###24562799
BACKGROUND	Many pathogenic processes and diseases are the result of an erroneous activation of the complement cascade and a number of inhibitors of complement have thus been examined for anti-inflammatory actions .
BACKGROUND	It was recently demonstrated that supraphysiological concentrations of the endogenous complement inhibitor MAp44 ( also denoted MAP1 ) protect against myocardial reperfusion injury .
BACKGROUND	In the present study , we examined the association between outcome after acute myocardial infarction ( MI ) and the plasma levels of MAp44 and its related proteins MASP-1 and MASP-3 in patients with first-time MI .
BACKGROUND	In addition , we compared plasma levels of MAp44 , MASP-1 , and MASP-3 in MI patients to levels in a healthy control group .
METHODS	A total of 192 MI patients and 140 control persons were included .
METHODS	Plasma samples were obtained and analysed with time-resolved immunofluorometric assays determining the plasma levels of MAp44 , MASP-1 , and MASP-3 .
METHODS	The myocardial outcomes ( salvage index and final infarct size ) were measured by gated single-photon emission CT. .
RESULTS	MI patients had 18 % higher plasma levels of MAp44 ( IQR 11-25 % ) as compared to the healthy control group ( p < 0.001 .
RESULTS	However , neither salvage index ( Spearman rho -0.1 , p = 0.28 ) nor final infarct size ( Spearman rho 0.02 , p = 0.83 ) correlated with plasma levels of MAp44 .
RESULTS	Likewise , MASP-1 and MASP-3 were elevated in MI patients ( p = 0.002 and p < 0.001 ) , but the levels were not correlated to outcome .
CONCLUSIONS	Plasma levels of MAp44 , MASP-1 , and MASP-3 are significantly higher in patients with MI compared to healthy control persons , but are not associated with short-term outcome measured as salvage index and final infarct .

###24099432
OBJECTIVE	We tested whether a brief cognitive behavioral ( CB ) group and bibliotherapy prevention reduce major depressive disorder ( MDD ) onset , depressive symptoms , and secondary outcomes relative to brochure controls in adolescents with self-reported depressive symptoms when school personnel recruit participants and deliver the intervention .
METHODS	Three hundred seventy-eight adolescents ( M age = 15.5 years , SD = 1.2 ; 68 % female , 72 % White ) with elevated self-assessed depressive symptoms were randomized to a 6-session CB group , minimal contact CB bibliotherapy , or educational brochure control .
METHODS	Participants were assessed at pretest , posttest , and 6-month follow-up .
RESULTS	CB group participants showed a significantly lower risk for major depressive disorder onset ( 0.8 % ) , compared to both CB bibliotherapy ( 6.3 % ) and brochure control ( 6.5 % ; hazard ratio = 8.1 and 8.3 , respectively ) .
RESULTS	Planned contrasts indicated that CB group resulted in lower depressive symptom severity than brochure control at posttest ( p = .03 , d = 0.29 ) but not 6-month follow-up ; differences between CB group and bibliotherapy were nonsignificant at posttest and 6-month follow-up .
RESULTS	Condition effects were nonsignificant for social adjustment and substance use .
CONCLUSIONS	The finding that a brief CB group intervention delivered by real-world providers significantly reduced MDD onset relative to both brochure control and bibliotherapy is very encouraging , although effects on continuous outcome measures were small or nonsignificant and approximately half the magnitude of those found in efficacy research , potentially because the present sample reported lower initial depression .

###7848884
BACKGROUND	The purpose of these two studies was to define the optimal therapeutic dose of the 5-HT3 receptor antagonist tropisetron ( Navoban , ICS 205-930 ) in cisplatin-induced nausea and vomiting .
METHODS	In two multicentre , dose-finding studies of tropisetron in the prevention of cisplatin-induced emesis , cancer patients nave to chemotherapy or who had not vomited previously were randomly assigned to tropisetron 5 , 10 , 20 or 40 mg ( study I , 143 patients ) or 2 or 5 mg ( study II , 74 patients ) , administered as a single intravenous dose over 15 minutes just before the start of chemotherapy .
RESULTS	In study I total control of acute symptoms ( no nausea and no vomiting ) was achieved in , respectively , 66 % , 50 % , 64 % and 50 % in the 5 - , 10 - , 20 - and 40-mg groups of patients .
RESULTS	A total absence of vomiting alone was seen in , respectively , 71 % , 51 % , 61 % or 58 % of patients .
RESULTS	None of the differences were statistically significant .
RESULTS	In study II there was total acute control in 57 % of patients in the 2-mg group and 63 % in the 5-mg group ( p = NS ) .
RESULTS	Total or major control of vomiting ( < or = 2 emetic episodes ) was the primary endpoint in study II and was seen in 68 % of patients for the 2-mg and 86 % for the 5-mg group ( p = 0.055 ) .
RESULTS	In this study failures ( > 3 vomiting ) were rescued with a second infusion of tropisetron ( 5-mg fixed dose ) .
RESULTS	Three of 8 rescue infusions administered in the 2-mg group prevented further vomiting whereas none of 5 were successful in the 5-mg group during course 1 of chemotherapy .
RESULTS	The most frequently reported adverse effects ( over all three courses ) were headache ( 6.0 % of 217 patients ) hypertension ( 3.7 % ) and diarrhoea ( 2.8 % ) .
RESULTS	None of the 25 deaths which occurred during the two studies were attributable to tropisetron .
CONCLUSIONS	Thus , a single dose of tropisetron provides 24-hour protection against cisplatin-induced nausea and vomiting and is well tolerated .
CONCLUSIONS	These studies do not allow a firm conclusion but suggest that 2 mg may be subtherapeutic and that 5 mg is as effective as higher doses .

###18492267
BACKGROUND	Daily interruption of sedation ( DIS ) and sedation algorithms ( SAs ) have been shown to decrease mechanical ventilation ( MV ) duration .
BACKGROUND	We conducted a randomized study comparing these strategies .
METHODS	Mechanically ventilated adults 18 years old or older in the medical intensive care unit ( ICU ) were randomly assigned to DIS or SA .
METHODS	Exclusion criteria were severe neurocognitive dysfunction , administration of neuromuscular blockers , and tracheostomy .
METHODS	Study endpoints were total MV duration and 28-day ventilator-free survival .
RESULTS	The study was terminated prematurely after 74 patients were enrolled ( DIS 36 and SA 38 ) .
RESULTS	The two groups had similar age , gender , racial distribution , Acute Physiology and Chronic Health Evaluation II score , and reason for MV .
RESULTS	The Data Safety Monitoring Board convened after DIS patients were found to have higher hospital mortality ; however , no causal connection between DIS and increased mortality was identified .
RESULTS	Interim analysis demonstrated a significant difference in primary endpoint , and study termination was recommended .
RESULTS	The DIS group had longer total duration of MV ( median 6.7 versus 3.9 days ; P = 0.0003 ) , slower improvement of Sequential Organ Failure Assessment over time ( 0.70 versus 0.23 units per day ; P = 0.025 ) , longer ICU length of stay ( 15 versus 8 days ; P < 0.0001 ) , and longer hospital length of stay ( 23 versus 12 days ; P = 0.01 ) .
CONCLUSIONS	In our cohort of patients , the use of SA was associated with reduced duration of MV and lengths of stay compared with DIS .
CONCLUSIONS	Based on these results , DIS may not be appropriate in all mechanically ventilated patients .
BACKGROUND	ClinicalTrials.gov NCT00205517 .

###15108607
OBJECTIVE	The aim of this study was to verify in bruxism patients the possible efficacy of auricular stimulation in reducing the hypertonicity of some masticatory muscles .
METHODS	Forty-three bruxism patients were randomly allocated to 3 groups : acupuncture , needle contact for 10 seconds , no treatment ( control ) .
METHODS	Helkimo 's clinical dysfunction index ( CDI ) and anamnestic dysfunction index ( ADI ) were used to assess the functional state of the masticatory system .
METHODS	The resting electrical activity of the anterior temporalis ( AT ) , masseter ( MM ) , digastric ( DA ) and sternocleidomastoid ( SCM ) muscles was measured , according to Jankelson , with surface electrodes at baseline , after stimulation and continually for 30 minutes ( 120 measurements in total ) .
METHODS	The electromyographical variations in the 3 groups were studied with t test for independent samples .
RESULTS	Acupuncture and needle contact were superior to control in reducing the muscle hypertonicity of all muscles except SCM .
RESULTS	In the comparison between acupuncture and needle contact the former showed better results only for the right TA and left DA ( p = 0.000 ) .
CONCLUSIONS	In this study it was possible to measure the efficacy of the stimulation of only one point or area , which is an ideal model for research in acupuncture .
CONCLUSIONS	The auricular area we chose for stimulation was never used before for the purpose of relaxing masticatory muscles .
CONCLUSIONS	Acupuncture and needle contact for 10 seconds showed similar effects .

###17064200
OBJECTIVE	To examine potential threats to internal and external study validity caused by differential patient withdrawal from a randomized controlled trial evaluating pharmacist management of hypertension , to compare the characteristics of patients who withdrew with those of patients who completed the study , and to identify characteristics that predispose patients to withdraw from hypertension management .
METHODS	Prospective , randomized , comparative study .
METHODS	Network of primary care clinics .
METHODS	Four hundred sixty-three patients with a diagnosis of hypertension and a last documented systolic blood pressure of 160 mm Hg or greater and/or diastolic blood pressure of 100 mm Hg or greater .
METHODS	Patients were randomly allocated to the pharmacist intervention or usual-care ( control ) group .
METHODS	Those in the pharmacist intervention group were collaboratively managed by a primary care clinical pharmacy specialist and their primary care provider .
METHODS	Patients in the control group received usual care from only their primary care provider .
RESULTS	Of the 463 patients , 191 ( 41 % ) withdrew from the study after randomization and 272 ( 59 % ) completed the study .
RESULTS	Patients who withdrew from the pharmacist intervention group were similar to patients who withdrew from the usual-care group with respect to age , sex , insurance status , and chronic conditions .
RESULTS	Patients who smoked or had commercial insurance were more likely to withdraw from the study than the other participants .
RESULTS	However , multivariate analysis of all variables , when adjusted for the effect of the intervention , revealed that insurance status was the only variable associated with a heightened probability of withdrawal ( p = 0.002 ) .
CONCLUSIONS	Although this study had a high withdrawal rate , between-group patient characteristics remained balanced .
CONCLUSIONS	Therefore , internal validity was preserved , and outcomes from the study groups could be reliably compared .
CONCLUSIONS	A lack of significant differences between patients who withdrew versus those who completed , with the exception of insurance status , suggests that external validity was not jeopardized .

###12476037
BACKGROUND	This two-way , randomized , single-dose , crossover study determined the pharmacokinetics and absolute oral bioavailability of telithromycin in young and elderly healthy subjects .
METHODS	Twelve young ( 18-40 years ) and 12 elderly ( > 65 years and < / = 85 years ) subjects received a single 800-mg oral dose of telithromycin or an intravenous infusion of 400 mg ( young subjects ) or 480 mg ( elderly subjects ) of telithromycin over 2.5 h in two treatment periods , separated by a 1-week washout period .
METHODS	The plasma concentrations and pharmacokinetic parameters of telithromycin and its major metabolite , RU 76363 , were determined .
METHODS	Absolute oral bioavailability was calculated using the area under the plasma concentration-time curve ( AUC ) from zero hours to infinity .
RESULTS	The absolute oral bioavailability of telithromycin was 57 % in both young and elderly subjects .
RESULTS	The AUC for the metabolite was lower after intravenous infusion of telithromycin , indicating first-pass loss following oral administration .
RESULTS	Telithromycin was well tolerated in both groups of subjects .
CONCLUSIONS	Telithromycin has an absolute oral bioavailability of 57 % in young and elderly subjects and is well tolerated .

###23279307
OBJECTIVE	Canagliflozin is a sodium glucose co-transporter 2 inhibitor in development for type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	The efficacy and safety of canagliflozin were evaluated in subjects with T2DM inadequately controlled with diet and exercise .
METHODS	In this 26-week , randomized , double-blind , placebo-controlled , phase 3 trial , subjects ( N = 584 ) received canagliflozin 100 or 300mg or placebo once daily .
METHODS	Primary endpoint was the change from baseline in haemoglobin A1c ( HbA1c ) at week 26 .
METHODS	Secondary endpoints included the proportion of subjects achieving HbA1c < 7.0 % ; change from baseline in fasting plasma glucose ( FPG ) , 2-h postprandial glucose ( PPG ) and systolic blood pressure ( BP ) ; and percent change in body weight , high-density lipoprotein cholesterol ( HDL-C ) and triglycerides .
METHODS	Adverse events ( AEs ) were recorded throughout the study .
RESULTS	At week 26 , HbA1c was significantly reduced from baseline with canagliflozin 100 and 300mg compared with placebo ( -0.77 , -1.03 and 0.14 % , respectively ; p < 0.001 for both ) .
RESULTS	Both canagliflozin doses significantly decreased FPG , 2-h PPG , body weight and systolic BP ( p < 0.001 for all ) , and increased HDL-C compared with placebo ( p < 0.01 for both ) .
RESULTS	Overall incidences of AEs were modestly higher with canagliflozin versus placebo ; rates of serious AEs and AE-related discontinuations were low and similar across groups .
RESULTS	Incidences of genital mycotic infections , urinary tract infections and osmotic diuresis-related AEs were higher with canagliflozin ; these led to few discontinuations .
RESULTS	The incidence of hypoglycaemia was low across groups .
CONCLUSIONS	Canagliflozin treatment improved glycaemic control , reduced body weight and was generally well tolerated in subjects with T2DM inadequately controlled with diet and exercise .

###25884724
BACKGROUND	Adults living in the sunny Australian climate are at high risk of skin cancer , but vitamin D deficiency ( defined here as a serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentration of less than 50 nmol/L ) is also common .
BACKGROUND	Vitamin D deficiency may be a risk factor for a range of diseases .
BACKGROUND	However , the optimal strategies to achieve and maintain vitamin D adequacy ( sun exposure , vitamin D supplementation or both ) , and whether sun exposure itself has benefits over and above initiating synthesis of vitamin D , remain unclear .
BACKGROUND	The Sun Exposure and Vitamin D Supplementation ( SEDS ) Study aims to compare the effectiveness of sun exposure and vitamin D supplementation for the management of vitamin D insufficiency , and to test whether these management strategies differentially affect markers of immune and cardio-metabolic function .
METHODS	The SEDS Study is a multi-centre , randomised controlled trial of two different daily doses of vitamin D supplementation , and placebo , in conjunction with guidance on two different patterns of sun exposure .
METHODS	Participants recruited from across Australia are aged 18-64 years and have a recent vitamin D test result showing a serum 25 ( OH ) D level of 40-60 nmol/L .
CONCLUSIONS	This paper discusses the rationale behind the study design , and considers the challenges but necessity of data collection within a non-institutionalised adult population , in order to address the study aims .
CONCLUSIONS	We also discuss the challenges of participant recruitment and retention , ongoing engagement of referring medical practitioners and address issues of compliance and participant retention .
BACKGROUND	Australia New Zealand Clinical Trials Registry : ACTRN12613000290796 Registered 14 March 2013 .

###25015740
BACKGROUND	Since the results from the randomized TARGIT A trial were published , intraoperative radiotherapy ( IORT ) is used more often .
BACKGROUND	IORT can be provided as accelerated partial breast irradiation ( APBI ) or as a boost .
BACKGROUND	The definition of suitable patients for IORT as APBI differs between different national societies ( e.g. ESTRO and ASTRO ) and different inclusion criteria of trials and so does the eligibility of patients .
BACKGROUND	This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials .
METHODS	Between 01/03 - 12/09 , 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim .
METHODS	Complete data sets for age , stage ( T , N , and M ) , histology and hormone receptor status were available in 1108 cases .
METHODS	Parameters to identify eligible patients are as follows : ESTRO : > 50 years , invasive ductal carcinoma/other favorable histology ( IDC ) , T1-2 ( 3 cm ) , N0 , any hormone receptor status , M0 ; ASTRO : 60 years , IDC , T1 , N0 , positive estrogen hormone receptor status , M0 ; TARGIT E `` elderly '' , risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology , phase II : 70 years , IDC , T1 , N0 , any hormone receptor status , M0 ; TARGIT C `` consolidation '' , risk adapted radiotherapy , phase IV : 50 years , IDC , T1 , N0 , positive hormone receptor status , M0 ; TARGIT BQR `` boost quality registry '' : every age , every histology , T1-2 ( max .
METHODS	3.5 cm ) , any hormone receptor status , N0 / + , M0 / + .
RESULTS	Out of the 1108 cases , 379 cases ( 34.2 % ) were suitable for IORT as APBI regarding the ESTRO and 175 ( 15.8 % ) regarding the ASTRO consensus statements .
RESULTS	82 ( 7.4 % ) patients were eligible for the TARGIT E trial , 258 ( 23.3 % ) for the TARGIT C trial and 671 ( 60.6 % ) for the TARGIT BQR registry .
RESULTS	According to the consensus statements of ASTRO ( 45.1 % ) and ESTRO ( 41.4 % ) about half of the eligible patients were treated with IORT as APBI .
RESULTS	From the eligible patients fulfilling the criteria for IORT boost ( 35 % ) about one third was eventually treated .
CONCLUSIONS	Patient selection for IORT should be restrictive .
CONCLUSIONS	For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements .

###23510357
BACKGROUND	The best strategy to protect individuals against meningococcal disease is to immunize against multiple serogroups .
BACKGROUND	Immunogenicity , antibody persistence , and safety of the EU-licensed meningococcal ACWY-tetanus toxoid conjugate vaccine ( MenACWY-TT ) were evaluated in healthy participants aged 11-55 years from the Philippines and Saudi Arabia .
METHODS	In this phase IIb , open , controlled study , 500 participants were randomised ( 3:1 ) to receive one dose of MenACWY-TT or a licensed meningococcal polysaccharide vaccine ( Men-PS ) .
METHODS	Functional antibody responses against meningococcal serogroups A , C , W-135 , and Y were assessed by a serum bactericidal antibody assay using rabbit complement ( rSBA ) at Month 0 , Month 1 , Year 1 , Year 2 , and Year 3 .
METHODS	Vaccine response was defined as an rSBA titre 32 at Month 1 in participants who were seronegative ( rSBA titre < 8 ) pre-vaccination and as at least a four-fold increase in titre in participants who were seropositive pre-vaccination .
METHODS	Solicited symptoms were recorded up to Day 4 , safety outcomes up to Month 6 , and serious adverse events related to vaccination up to Year 3 .
RESULTS	Pre-specified criteria for non-inferiority of MenACWY-TT versus Men-PS were met in terms of rSBA vaccine response and incidence of grade 3 general symptoms .
RESULTS	At Month 1 , 82.7 % -96.3 % of MenACWY-TT and 69.7 % -91.7 % in Men-PS recipients had a vaccine response for each serogroup .
RESULTS	At Year 3 , 99.1 % and 92.9 % of MenACWY-TT recipients retained rSBA titres 8 and 128 , respectively , as compared to 86.7 % and 80.0 % in the Men-PS group .
RESULTS	Both vaccines had a clinically acceptable safety profile , although injection site redness and swelling were more frequent in MenACWY-TT recipients .
CONCLUSIONS	These results suggest that MenACWY-TT could protect adolescents and adults against meningococcal disease up to three years post-vaccination .
BACKGROUND	This study is registered at http://www.clinicaltrials.gov/NCT00356369 .

###16627414
OBJECTIVE	Cardiac resynchronization therapy ( CRT ) confers sustained therapeutic benefits to patients suffering from congestive heart failure ( CHF ) due to systolic dysfunction associated with ventricular dyssynchrony .
OBJECTIVE	Biventricular ( BiV ) pacing has , thus far , been the preferred method , as it corrects both electrical and mechanical dyssynchrony .
OBJECTIVE	Left ventricular ( LV ) only pacing , which has conferred similar benefits in pilot studies , may be an alternative treatment method .
OBJECTIVE	` Biventricular vs. left univentricular pacing with ICD back-up in heart failure patients ' ( B-LEFT HF ) is an international , prospective , randomized , parallel-design , double-blind , clinical trial to examine whether LV only pacing is as safe and effective as BiV pacing in patients suffering from CHF .
RESULTS	The trial will randomly assign 172 patients to either LV only or BiV pacing .
RESULTS	The study has prospectively defined efficacy endpoints to be evaluated at 6 months , which are ( i ) changes in functional capacity and degree of reverse remodelling ( primary ) and ( ii ) changes in the heart failure clinical composite response ( secondary ) .
CONCLUSIONS	Because LV only pacing in CRT is likely to be technically less challenging and costly than BiV , a specifically designed study is needed to compare the safety and effectiveness of the two configurations .
CONCLUSIONS	B-LEFT HF has been designed to settle this critical issue .

###24139708
BACKGROUND	The quality of care provided to patients with cancer who are dying in hospital and their families is suboptimum .
BACKGROUND	The UK Liverpool Care Pathway ( LCP ) for patients who are dying was developed with the aim of transferring the best practice of hospices to hospitals .
BACKGROUND	We therefore assessed the effectiveness of LCP in the Italian context ( LCP-I ) in improving the quality of end-of-life care for patients with cancer in hospitals and for their family .
METHODS	In this pragmatic cluster randomised trial , 16 Italian general medicine hospital wards were randomly assigned to implement the LCP-I programme or standard health-care practice .
METHODS	For each ward , we identified all patients who died from cancer in the 3 months before randomisation ( preintervention ) and in the 6 months after the completion of the LCP-I training programme .
METHODS	The primary endpoint was the overall quality of care toolkit scale .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01081899 .
RESULTS	During the postintervention assessment , data were gathered for 308 patients who died from cancer ( 147 in LCP-I programme wards and 161 in control wards ) .
RESULTS	232 ( 75 % ) of 308 family members were interviewed , 119 ( 81 % ) of 147 with relatives cared for in the LCP-I wards ( mean cluster size 149 [ range eight to 22 ] ) and 113 ( 70 % ) of 161 in the control wards ( 141 [ eight to 22 ] ) .
RESULTS	After implementation of the LCP-I programme , no significant difference was noted in the distribution of the overall quality of care toolkit scores between the wards in which the LCP-I programme was implemented and the control wards ( score 705 of 100 vs 630 of 100 ; cluster-adjusted mean difference 76 [ 95 % CI -36 to 187 ] ; p = 0186 ) .
CONCLUSIONS	The effect of the LCP-I programme in our study is less than the effects noted in earlier phase 2 trials .
CONCLUSIONS	However , if the programme is implemented well it has the potential to reduce the gap in quality of care between hospices and hospitals .
CONCLUSIONS	Further research is needed to ascertain what components of the LCP-I programme might be effective and to develop and assess a wider range of approaches to quality improvement in hospital care for people at the end of their lives and for their families .
BACKGROUND	Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus .

###8961905
OBJECTIVE	To determine whether sulfasalazine ( SSZ ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis ( AS ) that is not controlled with nonsteroidal antiinflammatory drug therapy .
METHODS	Two hundred sixty-four patients with AS were recruited from 15 clinics , randomized ( double-blind ) to SSZ or placebo treatment , and followed up for 36 weeks .
METHODS	Treatment response was based on morning stiffness , back pain , and physician and patient global assessments .
RESULTS	While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment , no difference was seen at the end of treatment .
RESULTS	Response rates were 38.2 % for SSZ and 36.1 % for placebo ( P = 0.73 ) .
RESULTS	The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo ( P < 0.0001 ) .
RESULTS	AS patients with associated peripheral arthritis showed improvement that favored SSZ ( P = 0.02 ) .
RESULTS	Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints .
CONCLUSIONS	SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic , longstanding disease .
CONCLUSIONS	SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement .
CONCLUSIONS	This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients .

###14707568
OBJECTIVE	To evaluate the effects of a 48-hr neuromuscular blocking agents ( NMBA ) infusion on gas exchange over a 120-hr time period in patients with acute respiratory distress syndrome .
METHODS	Multiple center , prospective , controlled , and randomized trial .
METHODS	Four adult medical or mixed medical-surgical intensive care units .
METHODS	A total of 56 patients with acute respiratory distress syndrome with a PaO2/FiO2 ratio of < 150 at a positive end-expiratory pressure of > or = 5 cm H2O .
METHODS	After randomization , patients received either conventional therapy without NMBA ( control group ) or conventional therapy plus NMBA for the next 48 hrs .
METHODS	The initial ventilator mode was volume-assist/control .
METHODS	The ventilator remained on assist-control mode throughout the initial 48-hr period in both groups .
METHODS	Tidal volume was 6-8 mL/kg ideal body weight .
RESULTS	When analyzed for the entire 120 hrs , there was a significant effect of the NMBA on the course of PaO2/FiO2 ratio ( p = .021 ) .
RESULTS	Separate comparisons at each time point indicated that patients randomized to the NMBA group had a higher PaO2/FiO2 at 48 , 96 , and 120 hrs after randomization .
RESULTS	Moreover , a decrease of positive end-expiratory pressure ( p = .036 ) was only found in the NMBA group .
RESULTS	Two-way repeated-measures analysis of variance exhibited a decrease in positive end-expiratory pressure over time ( p = .036 ) .
RESULTS	Concerning short-term effects , there was no modification of PaO2/FiO2 ratio 1 hr after randomization in either group .
RESULTS	Only one patient ( from the control group ) developed pneumothorax .
CONCLUSIONS	Use of NMBA during a 48-hr period in patients with acute respiratory distress syndrome is associated with a sustained improvement in oxygenation .

###23084955
OBJECTIVE	To determine the effectiveness of exercise therapy ( ET ) compared with ET with adjunctive manual therapy ( MT ) for people with hip osteoarthritis ( OA ) ; and to identify if immediate commencement of treatment ( ET or ET+MT ) was more beneficial than a 9-week waiting period for either intervention .
METHODS	Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up .
METHODS	Four academic teaching hospitals in Dublin , Ireland .
METHODS	Patients ( N = 131 ) with hip OA recruited from general practitioners , rheumatologists , orthopedic surgeons , and other hospital consultants were randomized to 1 of 3 groups : ET ( n = 45 ) , ET+MT ( n = 43 ) , and waitlist controls ( n = 43 ) .
METHODS	Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks .
METHODS	Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up .
METHODS	Their data were pooled with original treatment group data : ET ( n = 66 ) and ET+MT ( n = 65 ) .
METHODS	The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) physical function ( PF ) subscale .
METHODS	Secondary outcomes included physical performance , pain severity , hip range of motion ( ROM ) , anxiety/depression , quality of life , medication usage , patient-perceived change , and patient satisfaction .
RESULTS	There was no significant difference in WOMAC PF between the ET ( n = 66 ) and ET+MT ( n = 65 ) groups at 9 weeks ( mean difference , .09 ; 95 % confidence interval [ CI ] -2.93 to 3.11 ) or 18 weeks ( mean difference , .42 ; 95 % CI , -4.41 to 5.25 ) , or between other outcomes , except patient satisfaction with outcomes , which was higher in the ET+MT group ( P = .02 ) .
RESULTS	Improvements in WOMAC , hip ROM , and patient-perceived change occurred in both treatment groups compared with the control group .
CONCLUSIONS	Self-reported function , hip ROM , and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip .
CONCLUSIONS	MT as an adjunct to exercise provided no further benefit , except for higher patient satisfaction with outcome .

###22334769
BACKGROUND	The purpose of this study was to investigate the clinical efficacy and safety of a fixed-dose combination of mometasone furoate/formoterol fumarate ( MF/F ) administered via a metered-dose inhaler in subjects with moderate-to-very severe chronic obstructive pulmonary disease ( COPD ) .
METHODS	This multicenter , double-blind , placebo-controlled trial had a 26-week treatment period and a 26-week safety extension .
METHODS	Subjects ( n = 1196 ) , at least 40 years old , were current or ex-smokers randomized to twice-daily inhaled MF/F 400/10 g , MF/F 200/10 g , MF 400 g , F 10 g , or placebo .
METHODS	The trial 's co-primary endpoints were mean changes from baseline , as area under the curve ( AUC ) , in forced expiratory volume ( FEV ( 1 ) ) over 0-12 hours ( AUC ( 0-12 h ) FEV ( 1 ) ) with MF/F versus MF , and in morning ( AM ) pre-dose ( trough ) FEV ( 1 ) with MF/F versus F after 13 weeks of treatment .
METHODS	Key secondary endpoints were the effects of MF/F on respiratory health status using the Saint George 's Respiratory Questionnaire ( SGRQ ) , symptom-free nights , partly stable COPD at 26 weeks , and time to first COPD exacerbation .
RESULTS	The largest improvements in AUC ( 0-12 h ) FEV ( 1 ) were observed with MF/F 400/10 g and MF/F 200/10 g. Serial spirometry results demonstrated that bronchodilator effects with MF/F occurred rapidly ( within 5 minutes ) , persisted for 12 hours after dosing , and were sustained over the 26-week treatment period .
RESULTS	Similar findings were observed for AM pre-dose FEV ( 1 ) , for which effects were further investigated , excluding subjects whose AM FEV ( 1 ) data were incorrectly collected after 2 days from the last dose of study treatment .
RESULTS	Improvements in SGRQ scores surpassed the minimum clinically important difference of more than four units with both MF/F treatments .
RESULTS	At 26 weeks , no notable between-treatment differences in the occurrence and nature of adverse events ( AEs ) were reported .
RESULTS	No unexpected AEs were observed .
RESULTS	Overall , 90 subjects reported AEs considered to be treatment-related , the most common of which were lenticular opacities , dysphonia , and oral candidiasis .
CONCLUSIONS	In conclusion , MF/F treatments improved lung function and respiratory health status , reduced exacerbations , and were well tolerated in subjects with moderate-to-very severe COPD .

###25213203
BACKGROUND	Transient post-ischemic LV dysfunction due to myocardial stunning in patients with coronary artery disease can be missed by conventional gated SPECT ( GSPECT ) acquisitions .
BACKGROUND	The aim of this IAEA-sponsored multi-center study was to determine whether early post-exercise imaging is more likely to detect stunning than conventional without adversely affecting image quality or perfusion information .
RESULTS	Patients undergoing exercise/rest GSPECT were enrolled in this international multicenter study .
RESULTS	Post-exercise studies were acquired at 15 5 minutes after radiotracer injection ( Stress-1 ) and repeated at 60 15 minutes ( Stress-2 ) .
RESULTS	Rest studies ( R ) were acquired at 60 minutes post injection .
RESULTS	A core laboratory quantitatively assessed perfusion pattern and LV blinded to the acquisition time .
RESULTS	Ischemia was defined as summed stress score ( SDS ) 4 , and stunning was defined as the difference between rest and post-stress LVEF ( - LVEF ) .
RESULTS	In the 229 patients enrolled into the study , both image quality and perfusion information were similar between Stress-1 and Stress-2 .
RESULTS	Post-stress LVEF was associated with both ischemia and time of acquisition , with a significant correlation between SDS and - LVEF , which was stronger at Stress-1 than Stress-2 in the ischemic compared to the non-ischemic population ( r = 0.23 vs 0.08 , P = 0.10 ) .
CONCLUSIONS	Early post-exercise imaging is feasible , and can potentially improve the detection of post-ischemic stunning without compromising image quality and perfusion data .

###16652085
BACKGROUND	Nasal polyposis is an inflammatory disease of unknown etiology .
BACKGROUND	This study aimed to evaluate the effect of a short course of oral prednisone followed by intranasal budesonide on nasal symptoms , polyp size , nasal flow , and computed tomography scan .
METHODS	Eighty-four patients with severe nasal polyps were included .
METHODS	After a steroid washout period , patients were randomized into two groups : group A ( n = 63 ) received oral prednisone for 2 weeks and group B ( n = 21 ) did not receive any steroid treatment .
METHODS	Patients from group A received intranasal budesonide for 12 weeks .
RESULTS	Atopy was positive in 36.8 % of patients .
RESULTS	Blood eosinophilia was higher in asthmatic ( 7.2 + / - 0.7 % , P < .05 ) than in nonasthmatic ( 3.0 + / - 0.4 % ) patients .
RESULTS	Asthmatic patients showed higher scores on nasal obstruction and loss of smell than nonasthmatics .
RESULTS	Oral steroids caused a significant improvement in all nasal symptoms and improved polyp size ( 2.1 + / - 0.1 , P < .05 ) and nasal flow ( 560 + / - 35 cm/s , P < .05 ) compared with nontreated patients ( 2.8 + / - 0.1 and 270 + / - 34 cm/s , respectively ) .
RESULTS	Intranasal budesonide maintained the improvement on nasal symptoms , polyp size , and nasal flow .
RESULTS	Steroid treatment reduced the computed tomography scan score ( 15.4 + / - 1 , P < .05 ) compared with before treatment ( 18.2 + / - 0.8 ) .
CONCLUSIONS	A short course of oral steroids improved all nasal symptoms , polyp size , and nasal flow , whereas intranasal steroid maintain this effect .

###20634438
OBJECTIVE	To determine whether oral administration of the antifungal fluconazole during the entire period of treatment of bacterial peritonitis ( BP ) , exit-site infection ( ESI ) , or tunnel infection ( TI ) prevents later appearance of fungal peritonitis ( called secondary ) in patients with chronic kidney disease stage 5 in a peritoneal dialysis ( PD ) program .
METHODS	All patients treated in the PD program in RTS Ltda Sucursal Caldas , during the period 1 June 2004 to 30 October 2007 were screened .
METHODS	Patients that had infectious bacterial complications ( BP , ESI , TI ) were included in a prospective randomized trial to receive or not receive oral fluconazole ( 200 mg every 48 hours ) throughout the time period required by the administration of therapeutic antibiotics via any route .
METHODS	It was evaluated whether the fungal peritonitis complication appeared within 30 - 150 days following the end of antibacterial treatment .
METHODS	Based on local results , the sample size necessary to obtain statistically significant results was determined to be 434 episodes of peritonitis .
RESULTS	The 434 episodes of peritonitis presented between the previously specified dates and during this same period there were 174 ESI or TI , of which only 52 received oral antibiotic treatment .
RESULTS	Information in relation to consumption of antibiotics for purposes other than BP , ESI , and TI was not reliable and thus this variable was excluded .
RESULTS	Among the episodes of peritonitis , 402 ( 92.6 % ) were of bacterial origin and 32 ( 7.3 % ) were mycotic , mainly Candida species [ 30 ( 93.75 % ) ] .
RESULTS	Of the fungal peritonitis , 14 ( 43.73 % ) were primary ( without prior use of antibiotics ) and 18 ( 56.25 % ) were secondary .
RESULTS	In the group of patients that received prophylaxis with fluconazole ( 210 for BP and 26 for ESI or TI ) , only 3 occurrences of fungal peritonitis were observed within 30 - 150 days of its administration , which is opposite to the group without prophylaxis ( 210 for BP and 26 for ESI or TI ) , in which 15 occurrences of fungal peritonitis were detected .
RESULTS	Statistical analysis of the group of patients with BP found comparisons of the proportions of those receiving fluconazole ( 0.92 % ) or not ( 6.45 % ) presented a highly significant difference in favor of prophylaxis ( p = 0.0051 , Z = 2.8021 ) .
RESULTS	Given that only 1 patient in each group with ESI or TI , with or without prophylaxis , presented the complication fungal peritonitis , it was concluded that this result was not statistically significant .
RESULTS	During laparoscopic surgery attempting reintroduction of the peritoneal catheter , it was found that 11 patients had severe adhesions or peritoneal fibrosis leading to obliteration of the peritoneal cavity .
RESULTS	In 19 patients , reintroduction of the catheter was possible and the patients returned to PD without consequence .
CONCLUSIONS	In patients with bacterial peritonitis , administration of prophylactic oral fluconazole throughout the time they received antibiotics significantly prevented the appearance of secondary fungal peritonitis .

###22230203
OBJECTIVE	Following treatment for colorectal cancer it is common practice for patients to attend hospital clinics at regular intervals for routine monitoring , although debate persists on the benefits of this approach .
OBJECTIVE	Nurse-led telephone follow-up is effective in meeting information and psycho-social needs in other patient groups .
OBJECTIVE	We explored the potential benefits of nurse-led telephone follow-up for colorectal cancer patients .
METHODS	Sixty-five patients were randomized to either telephone or hospital follow-up in an exploratory randomized trial .
RESULTS	The telephone intervention was deliverable in clinical practice and acceptable to patients and health professionals .
RESULTS	Seventy-five per cent of eligible patients agreed to randomization .
RESULTS	High levels of satisfaction were evident in both study groups .
RESULTS	Appointments in the hospital group were shorter ( median 14.0 min , range 2.3-58 .0 ) than appointments in the telephone group ( median 28.9 min , range 6.1-48 .3 ) .
RESULTS	Patients in the telephone arm were more likely to raise concerns during consultations .
CONCLUSIONS	Historical approaches to follow-up unsupported by evidence of effectiveness and efficiency are not sustainable .
CONCLUSIONS	Telephone follow-up by specialist nurses may be a feasible option .
CONCLUSIONS	A main trial comparing hospital and telephone follow-up is justified , although consideration needs to be given to trial design and practical issues related to the availability of specialist nurses at study locations .

###9475565
BACKGROUND	The efficacy and safety of regular-strength beclomethasone dipropionate MDI prescribed within its recommended dosing range of 2 to 5 puffs three to four times daily has been well established in more than 25 years of worldwide use .
BACKGROUND	A more concentrated formulation delivering 84 microg per puff was developed to provide for a more convenient twice-daily dosing regimen .
OBJECTIVE	This randomized , single-blinded , positive and placebo-controlled , parallel-group , multiple-dose bioactivity study was conducted to assess the potential of a new beclomethasone dipropionate 84 microg double-strength metered-dose inhaler ( Vanceril 84 microg Double Strength Inhalation Aerosol/Key ) to cause hypothalamic-pituitary-adrenocortical axis suppression .
METHODS	Beclomethasone dipropionate double-strength 84 microg was compared with beclomethasone dipropionate regular-strength 42 microg , orally administered prednisone , and placebo inhaler after 36 consecutive days of administration in adults with moderate asthma .
METHODS	Beclomethasone dipropionate double-strength was administered as 5 puffs BID and beclomethasone dipropionate regular-strength was administered as 10 puffs BID for the same total daily dose of 840 microg of beclomethasone dipropionate .
METHODS	Oral prednisone was administered by mouth at 10 mg once a day .
METHODS	The potential for hypothalamic-pituitary-adrenocortical axis suppression was evaluated by an adrenocorticotropic hormone ( ACTH ) stimulation test using cosyntropin 250 microg in 500 mL normal saline infused over six hours on the 36th day of treatment .
METHODS	Sixty-four patients completed this study .
RESULTS	No clinically significant post-study findings were observed from physical examination , electrocardiogram , or clinical laboratory evaluation for any treatment group .
RESULTS	No serious or unexpected adverse events were reported .
RESULTS	On the 36th day of treatment , there was a significant ( P < .01 ) difference in the plasma cortisol concentration response to cosyntropin stimulation between the prednisone and placebo treatment groups at the sixth hour of infusion .
RESULTS	There was no significant difference in the plasma cortisol concentration response to cosyntropin stimulation between the beclomethasone dipropionate double-strength and beclomethasone dipropionate regular-strength treatment groups and the placebo group .
RESULTS	In addition , comparison of the response between the beclomethasone dipropionate double-strength and beclomethasone dipropionate regular-strength groups showed no significant difference .
CONCLUSIONS	Beclomethasone dipropionate , administered either via a double-strength ( 84 microg/puff ) or regular-strength ( 42 microg/puff ) inhaler dosed at 840 microg/day showed no evidence of hypothalamic-pituitary-adrenocortical axis suppression in adults with moderate asthma .

###10149693
BACKGROUND	Little information is available in the performance of infant ventilation by basic life support ( BLS ) personnel .
OBJECTIVE	There are no significant differences between mouth-to-mouth ( M-M ) , mouth-to-mask ( M-Ma ) , pediatric bag-mask ( PBM ) , and adult bag-mask ( ABM ) devices in the percent of acceptable breaths delivered by BLS providers .
METHODS	Fifty certified BLS providers performed five ventilation methods in random sequences for 60 seconds each on a 5kg infant mannequin following standardized instructions .
METHODS	Supplemental oxygen , 10 l/min , was supplied with one M-Ma trial and PBM methods .
METHODS	Airway patency , peak airway pressure ( PAP ) , ventilatory rate ( VR ) , tidal volume , and delivered oxygen concentration ( FiO 2 ) were recorded .
METHODS	The percent of breaths with excessive PAP ( i.e. , greater than 30 mmHg ) , percent of acceptable breaths using loose ( i.e. , 25-125ml ) and strict ( i.e. , 50-100ml ) criteria , and FiO 2 at 15 , 30 , 45 , and 60 seconds were compared between ventilation methods using ANOVA .
RESULTS	For all subjects and those with a patent airway ( n = 36 ) , there were no significant differences in the percentage of acceptable breaths produced by PBM ( 56 + / -6 ) ( mean + / - SEM ; all subjects ) and ABM ( 41 + / -6.2 ) was significantly greater than M-Ma , with and without a patent airway .
RESULTS	Although RR and the percentage of excessive breaths were not significantly different , the percentage of acceptable breaths and FiO 2 delivered with each ventilation method was significantly better in the patent airway group .
RESULTS	( ABSTRACT TRUNCATED AT 250 WORDS )

###10702886
OBJECTIVE	In vitro results are inconclusive as to whether cilostazol is metabolised by cytochrome P450 isoenzyme 2D6 ( CYP2D6 ) .
OBJECTIVE	The goals of this study were ( 1 ) to assure the dose of quinidine and timing relative to cilostazol used in this study were adequate to cause inhibition of CYP2D6 , ( 2 ) to evaluate carryover effects of quinidine administration , and ( 3 ) to evaluate the effect of CYP2D6 deficiency and administration of quinidine ( a CYP2D6 inhibitor ) on the pharmacokinetics of a single 100 mg oral dose of cilostazol .
METHODS	This study was conducted as a single-centre , open-label , randomised sequence , 2-period , crossover pharmacokinetic trial .
METHODS	Water alone ( treatment without quinidine ) or two 200 mg oral doses of quinidine sulfate with water were administered 25 hours and 1 hour prior to a single 100 mg dose of cilostazol in period 1 .
METHODS	Study participants were crossed over to opposite treatment in period 2 .
METHODS	Metoprolol 25 mg , used as a positive control , was administered 1 hour after quinidine sulfate with water or using water alone to assess the magnitude of CYP2D6 inhibition by quinidine .
METHODS	22 healthy nonsmoking Caucasian ( 14 male and 8 female ) volunteers participated in the study .
METHODS	Serial blood and urine samples were collected at predose and after cilostazol administration to characterise cilostazol and its metabolite pharmacokinetics .
METHODS	Additional plasma samples were taken to assess the pharmacokinetics of quinidine .
METHODS	Urine samples were collected to measure metoprolol and hydroxymetoprolol .
RESULTS	Administration of metoprolol with quinidine caused a significant ( p < 0.001 ) decrease in the urinary 4-hydroxymetoprolol/metoprolol ratio compared with administration of metoprolol alone ( 42-fold decrease , 0.065 vs 2.707 ) .
RESULTS	Hence , quinidine effectively converted extensive metabolisers of CYP2D6 to poor metabolisers of CYP2D6 .
RESULTS	The 21-day washout period was adequate to have complete recovery from quinidine inhibition of CYP2D6 .
RESULTS	The analysis of variance demonstrated that the mean maximum plasma concentration ( Cmax ) for cilostazol , both adjusted and unadjusted for the free fraction , was higher in the control group than in the quinidine group ( p = 0.023 ) .
RESULTS	However , the time to Cmax ( p = 0.669 ) , the area under the plasma concentration-time curve from time zero to infinity ( AUC infinity ; p = 0.133 ) , and the apparent oral clearance ( p = 0.135 ) were unchanged .
RESULTS	The geometric mean ratios ( 90 % confidence interval ) comparing with quinidine ( test ) and without quinidine ( reference ) coadministration for Cmax and AUC infinity are 0.86 ( 0.77 , 0.95 ) and 0.92 ( 0.84 , 1.00 ) , respectively .
RESULTS	Similar patterns were observed for OPC-13015 and OPC-13213 with regard to Cmax , area under the plasma concentration-time curve from time zero to the last measurable concentration at time t , and AUC infinity ( where determinable ) .
RESULTS	The slight decrease in the systemic availability of cilostazol and its metabolites was thought to be a result of the increased gastrointestinal motility secondary to quinidine .
CONCLUSIONS	Administration of quinidine sulfate 200 mg profoundly inhibited CYP2D6-mediated metabolism .
CONCLUSIONS	The effects of quinidine inhibition of CYP2D6 metabolism were completely reversible during the 21-day washout period .
CONCLUSIONS	Coadministration of quinidine with cilostazol had no substantial effect on cilostazol or its metabolites ( OPC-13015 and OPC-13213 ) .
CONCLUSIONS	Hence , CYP2D6 does not have a significant contribution in the metabolic elimination of cilostazol .

###17118648
OBJECTIVE	The primary aims were to study risk factors for an ipsilateral breast event ( IBE ) after sector resection for ductal carcinoma in situ of the breast ( DCIS ) in a trial comparing adjuvant radiotherapy to no therapy and to assess predictive factors for response to radiotherapy .
OBJECTIVE	Secondary aims were to analyse reproducibility of the histopathological evaluation and to estimate correctness of diagnosis in the trial .
METHODS	A randomised trial in Sweden ( the SweDCIS trial ) , including 1046 women with a median of 5.2 years of follow-up in a population , offered routine mammographic screening .
METHODS	A case-cohort design with a total of 161 cases of IBE ( 42 of those being members of the subcohort ) and 284 sampled for the sub-cohort .
METHODS	Ninety five percent of the participants ' slides could be retrieved and were re-evaluated by three experienced pathologists .
RESULTS	Low nuclear grade ( NG 1-2 ) and absence of necrosis halves the risk of IBE in both irradiated and non-irradiated patients .
RESULTS	Lesion size , margins of excision and age at diagnosis did not modify these associations .
RESULTS	The presence of necrosis modified the effect of radiotherapy : relative risk was 0.40 with necrosis present and 0.07 with necrosis absent ( p-value for interaction 0.068 ) .
RESULTS	In all subsets of prognostic factors , radiotherapy conferred a substantial benefit .
RESULTS	The risk factors for in situ and invasive IBE were similar .
RESULTS	The agreement between pathologists was moderate ( kappa = 0.486 ) .
RESULTS	Correctness of diagnosis in the subcohort of SweDCIS was 84.8 % .
CONCLUSIONS	Although nuclear grade and necrosis carry prognostic information , we could not define a group with very low risk after sector resection alone .
CONCLUSIONS	Radiotherapy has a protective effect in all substrata of risk factors studied .
CONCLUSIONS	The interaction between the presence of necrosis and radiotherapy is a clinically and biologically relevant research area .

###9386112
BACKGROUND	Vasodilatory shock requiring catecholamine pressors occurs in some patients following cardiopulmonary bypass .
BACKGROUND	Prompted by a clinical observation , we investigated the use of vasopressin as a treatment for this syndrome in a randomized , controlled trial .
RESULTS	Patients undergoing placement of a left ventricular assist device ( n = 23 ) were evaluated for post-bypass vasodilatory shock requiring catecholamine pressors , and consecutive eligible subjects ( n = 10 ) were evenly randomized to blinded intravenous vasopressin or saline placebo .
RESULTS	Vasopressin ( 0.1 U/min ) increased mean arterial pressure ( 57 + / -4 to 84 + / -2 mm Hg , P < .001 ) and systemic vascular resistance ( 813 + / -113 to 1188 + / -87 dyne-s/cm5 , P < .001 ) , with decreased norepinephrine administration .
RESULTS	There was no significant response to saline , but in three subjects who crossed over , blinded vasopressin increased mean arterial pressure ( 69 + / -8 to 93 + / -4 mm Hg ) and systemic vascular resistance ( 898 + / -88 to 1443 + / -72 dyne-s/cm5 ) with decreased norepinephrine administration .
RESULTS	Plasma vasopressin concentrations prior to randomization clustered in two groups : one ( n = 5 ) with concentrations inappropriately low for the degree of hypotension ( 8.4 + / -2.1 pg/mL ) and a second ( n = 3 ) with moderately elevated levels ( 33.7 + / -1.6 pg/mL ) ; vasopressin increased mean arterial pressure in the low vasopressin group from 57 + / -4 to 85 + / -2 mm Hg ( P < .01 ) and in the high vasopressin group from 68 + / -8 to 86 + / -4 mm Hg .
CONCLUSIONS	Vasopressin is an effective pressor in vasodilatory shock after cardiopulmonary bypass .
CONCLUSIONS	An absolute vasopressin deficiency was observed in the majority of patients , but all subjects responded to vasopressin administration .

###16880313
OBJECTIVE	To estimate the incidence of cytological abnormalities and cervical cancer and to determine the effect of oral estrogen and progestin on cervical cytology among postmenopausal women participating in a multi-institution clinical trial .
METHODS	The study was a longitudinal analysis of a prospective cohort of 16,608 postmenopausal women ( aged 50-79 years ) participating in the Women 's Health Initiative ( WHI ) clinical trial of estrogen plus progestin .
METHODS	Eligible participants had a cervical smear within 1 year before randomization and at 3 - and 6-year follow-ups .
METHODS	Outcomes measured were low-grade and high-grade squamous intraepithelial lesions ( LSIL , HSIL ) and cervical cancer at follow-up years 3 and 6 .
RESULTS	Of 15,733 eligible participants with a uterus , 7,663 were assigned to placebo and 8,070 to estrogen plus progestin .
RESULTS	At baseline , 318 women ( 2 % ) had low-grade abnormalities on cervical cytology .
RESULTS	The annual incidence rate of any new cytological abnormality in the estrogen plus progestin group was significantly higher than that in the placebo group ( hazard ratio 1.4 , 95 % confidence interval [ CI ] 1.2-1 .6 ) .
RESULTS	Independent risk factors for HSIL and cervical cancer over a 6-year follow-up ( after stratifying for baseline cytologic abnormalities ) included sexual activity in the past year while not being married or living as married ( hazard ratio 3.5 , 95 % CI 1.5-8 .3 ) .
RESULTS	Risk factors did not include age or use of estrogen plus progestin .
CONCLUSIONS	Use of estrogen plus progestin was associated with increased incidence of any cytologic abnormality , although it had no impact on the incidence of HSIL or cervical cancer .
CONCLUSIONS	Sexually active older women who are not married or living as married may benefit from continued cervical cancer screening .
BACKGROUND	Clinicaltrials.gov , www.clinicaltrials.gov , NCT00000611 .

###10636270
OBJECTIVE	The aim of this study was to describe the electrocardiographic ( ECG ) evolutionary changes after an acute myocardial infarction ( AMI ) and to evaluate their correlation with left ventricular function and remodeling .
BACKGROUND	The QRS complex changes after AMI have been correlated with infarct size and left ventricular function .
BACKGROUND	By contrast , the significance of T wave changes is controversial .
METHODS	We studied 536 patients enrolled in the GISSI-3-Echo substudy who underwent ECG and echocardiographic studies at 24 to 48 h ( S1 ) , at hospital discharge ( S2 ) , at six weeks ( S3 ) and six months ( S4 ) after AMI .
RESULTS	The number of Qwaves ( nQ ) and QRS quantitative score ( QRSs ) did not change over time .
RESULTS	From S2 to S4 , the number of negative T waves ( nT NEG ) decreased ( p < 0.0001 ) , wall motion abnormalities ( % WMA ) improved ( p < 0.001 ) , ventricular volumes increased ( p < 0.0001 ) while ejection fraction remained stable .
RESULTS	According to the T wave changes after hospital discharge , patients were divided into four groups : stable positive T waves ( group 1 , n = 35 ) , patients who showed a decrease > or = 1 in nT NEG ( group 2 , n = 361 ) , patients with no change in nT NEG ( group 3 , n = 64 ) and those with an increase > or = 1 in nT NEG ( group 4 , n = 76 ) .
RESULTS	The QRSs and nQ remained stable in all groups .
RESULTS	Groups 3 and 4 showed less recovery in % WMA , more pronounced ventricular enlargement and progressive decline in ejection fraction than groups 1 and 2 ( interaction time x groups p < 0.0001 ) .
CONCLUSIONS	The analysis of serial ECG can predict postinfarct left ventricular remodeling .
CONCLUSIONS	Normalization of negative T waves during the follow-up appears more strictly related to recovery of regional dysfunction than QRS changes .
CONCLUSIONS	Lack of resolution and late appearance of new negative T predict unfavorable remodeling with progressive deterioration of ventricular function .

###11130216
OBJECTIVE	To compare the steady-state pharmacokinetics of citalopram after multiple-dose administration in elderly and young subjects , and to correlate pharmacokinetic measurements with tolerability .
METHODS	Single-blind , multiple-dose , dose-escalating , randomized , placebo-controlled trial .
METHODS	The Orlando Clinical Research Center , Orlando , Florida .
METHODS	Twenty-four healthy elderly and eight healthy young men and women .
METHODS	Subjects randomized to citalopram received 10 mg once/day for the first week , 20 mg once/day for the second week , and 40 mg once/day for the remaining 3 weeks .
RESULTS	Blood samples were collected weekly to determine steady-state pharmacokinetics of citalopram and its primary metabolites .
RESULTS	During dose escalation , samples were collected just before dose increase .
RESULTS	After the final dose , blood samples were collected periodically over 480 hours to characterize the terminal elimination phase .
RESULTS	In elderly subjects , maximum concentration , time associated with the maximum concentration , area under the concentration versus time curve from 0-24 hours , half-life , and volume of distribution were all slightly increased ; oral clearance was slightly decreased .
RESULTS	However , only half-life was statistically different between the groups , 30 % longer in the elderly .
RESULTS	In addition , the frequency and severity of adverse events were comparable between the two age groups and did not appear to be dose related .
CONCLUSIONS	The pharmacokinetics and tolerability of citalopram in elderly subjects are similar to those observed in younger subjects .
CONCLUSIONS	The slight differences observed in the elderly likely reflect declining liver and kidney function .

###17966969
BACKGROUND	In type 2 diabetes , metformin reduces cardiovascular risk beyond the effect of glycaemic control .
BACKGROUND	Since oxidative stress and the consequent enhanced platelet activation contribute to accelerated atherosclerosis in diabetes , we hypothesized that metformin could reduce oxidative stress in this condition .
METHODS	We randomized 26 newly diagnosed type 2 diabetic subjects to assume either metformin ( M , n = 13 ) or gliclazide ( G , n = 13 ) for 12 weeks .
METHODS	Drugs were titrated as needed to achieve good glycaemic control .
METHODS	Before and after treatment , we determined blood glucose , insulin , HbA ( 1c ) , vitamin A and E levels and 8-iso-PGF ( 2alpha ) and 11-dehydro-thromboxane B ( 2 ) urinary excretion , an in vivo oxidative stress and a thromboxane-dependent platelet activation marker , respectively .
RESULTS	Notwithstanding a comparable improvement in metabolic control , 8-iso-PGF ( 2alpha ) ( M from 708 + / - 32 to 589 + / - 45 pg/mg cr , p < 0.001 ; G from 646 + / - 80 to 665 + / - 79 , pg/mg cr , p = ns ) and 11-dehydro-thromboxane B ( 2 ) ( M from 2190 + / - 196 to 1753 + / - 150 pg/mg cr , p < 0.05 ; G from 2048 + / - 202 to 1923 + / - 223 , pg/mg cr , p = ns ) urinary excretion decreased after metformin but not after gliclazide treatment .
RESULTS	After metformin , vitamin A and E levels significantly increased while they remained unchanged after gliclazide .
CONCLUSIONS	These data suggest that metformin could improve oxidative stress , preserve antioxidant function and restrain platelet activation in type 2 diabetes .

###16406076
OBJECTIVE	To prospectively compare contact diode laser for myringotomy ( CDLM ) to myringotomy with tube insertion ( M&T ) for the surgical management of otitis media with effusion ( OME ) in children .
METHODS	Prospective randomized controlled study at a tertiary care pediatric institution .
METHODS	Thirty children for whom PE tube insertion was indicated were randomized for treatment by CDLM or by M&T , in order to investigate length of time for middle ear ventilation , and complication rates .
METHODS	Surgical time was measured , post-operative parental questionnaires were reviewed , and follow-up examinations were performed .
METHODS	Middle ear ventilation by CDLM or M&T .
RESULTS	Middle ear ventilation by CDLM took an average of 4.1 min , and was maintained for an average of 3.5 months , compared to surgical time of 10.2 min for M&T , and duration of middle ear ventilation of 6.3 months .
RESULTS	These differences were statistically significant ( p = 0.005 for surgical time , and p < 0.001 for duration of ventilation ) .
RESULTS	Complication rates were equivalent .
CONCLUSIONS	CDLM allowed for medium-duration middle ear ventilation in children compared to M&T .
CONCLUSIONS	Further study to clarify the role of CDLM in the management of OME in children is indicated .

###12045491
OBJECTIVE	To evaluate the safety and efficacy of once daily doses of tenofovir DF ( TDF ) administered in combination with other antiretroviral therapy ( ART ) in treatment-experienced HIV-1-infected patients with incomplete virological suppression .
METHODS	One-hundred and eighty-nine subjects with plasma HIV-1 RNA levels between 400 and 100,000 copies/ml and stable ART ( > or = 8 weeks ) were randomized ( 2 : 2 : 2 : 1 ratio ) to add TDF 75 mg , 150 mg , or 300 mg or placebo to existing ART in a double-blinded manner .
METHODS	After 24 weeks , patients initially randomized to placebo received blinded TDF 300 mg .
METHODS	Efficacy was analyzed by the mean changes HIV-1 RNA levels ( log10 copies/ml plasma ; DAVG (xx) ) from week 0 to weeks 4 , 24 , and 48 .
METHODS	Safety was analyzed by incidence of grade 3 or 4 clinical and laboratory adverse events .
RESULTS	At baseline , patients had mean 4.6 years prior ART use with 94 % having HIV-1 with nucleoside-associated resistance mutations .
RESULTS	There were statistically significant decreases in DAVG ( 4 ) and DAVG ( 24 ) for all doses of TDF compared with placebo , with the greatest effect seen with TDF 300 mg ( DAVG ( 4 ) , -0.62 , P < 0.001 ; DAVG ( 24 ) , -0.58 ; P < 0.001 ; DAVG ( 48 ) , -0.62 ) .
RESULTS	The incidence of adverse events was similar among the TDF groups and placebo through week 24 .
RESULTS	Throughout the 48-week study , no significant changes in renal function were observed .
CONCLUSIONS	In treatment-experienced patients with baseline nucleoside resistance mutations , TDF provided dose-related , durable reductions in HIV-1 RNA .
CONCLUSIONS	Through 24 weeks , the safety profile of TDF was similar to that of placebo .

###11907289
BACKGROUND	Endothelin-1 is a potent vasoconstrictor and smooth-muscle mitogen .
BACKGROUND	In a preliminary study , the orally administered dual endothelin-receptor antagonist bosentan improved exercise capacity and cardiopulmonary hemodynamics in patients with pulmonary arterial hypertension .
BACKGROUND	The present trial investigated the effect of bosentan on exercise capacity in a larger number of patients and compared two doses .
METHODS	In this double-blind , placebo-controlled study , we randomly assigned 213 patients with pulmonary arterial hypertension ( primary or associated with connective-tissue disease ) to receive placebo or to receive 62.5 mg of bosentan twice daily for 4 weeks followed by either of two doses of bosentan ( 125 or 250 mg twice daily ) for a minimum of 12 weeks .
METHODS	The primary end point was the degree of change in exercise capacity .
METHODS	Secondary end points included the change in the Borg dyspnea index , the change in the World Health Organization ( WHO ) functional class , and the time to clinical worsening .
RESULTS	At week 16 , patients treated with bosentan had an improved six-minute walking distance ; the mean difference between the placebo group and the combined bosentan groups was 44 m ( 95 percent confidence interval , 21 to 67 ; P < 0.001 ) .
RESULTS	Bosentan also improved the Borg dyspnea index and WHO functional class and increased the time to clinical worsening .
CONCLUSIONS	The endothelin-receptor antagonist bosentan is beneficial in patients with pulmonary arterial hypertension and is well tolerated at a dose of 125 mg twice daily .
CONCLUSIONS	Endothelin-receptor antagonism with oral bosentan is an effective approach to therapy for pulmonary arterial hypertension .

###23508563
BACKGROUND	A limitation of Bier 's block or i.v. regional anaesthesia ( IVRA ) is tourniquet pain .
BACKGROUND	We hypothesized that tourniquet placement on the forearm vs upper arm during IVRA for distal upper extremity surgery may result in less tourniquet pain , lower the need for analgesic interventions , and decrease post-anaesthesia care unit ( PACU ) admission .
METHODS	Patients for distal upper extremity surgery were randomized into upper or forearm single-cuff tourniquet placement .
METHODS	IVRA was either performed with 15 ml of 2 % lidocaine and 20 mg ketorolac in the upper group or 8 ml of 2 % lidocaine and 10 mg ketorolac in the forearm group .
METHODS	Vital signs and visual analogue scale ( VAS ) score were recorded .
METHODS	If VAS score was > 4 , 50 g fentanyl was injected .
METHODS	If the patient had VAS scores > 6 with fentanyl , deep sedation with propofol was administered .
RESULTS	Twenty-eight subjects were in each group .
RESULTS	There were no significant differences in patient characteristics , tourniquet time , or pressure between the groups .
RESULTS	Ten patients in the forearm vs 27 in the upper arm group had a VAS score > 4 .
RESULTS	The mean fentanyl use was 30 g in the forearm group vs 104 g in the upper arm group .
RESULTS	One patient in the forearm group required propofol vs 22 in the upper arm group .
RESULTS	PACU bypass to phase 2 recovery occurred 19 times in the forearm group vs zero times in the upper arm group ( P < 0.0001 ) .
CONCLUSIONS	Our results indicate that the placement of the tourniquet on the forearm resulted in less discomfort , fewer sedation interventions , and greater likelihood of bypassing the PACU when compared with upper arm tourniquet .

###16192451
BACKGROUND	Iseganan , an antimicrobial peptide , is active against aerobic and anaerobic gram-positive and gram-negative bacteria as well as fungi and yeasts .
BACKGROUND	The drug has shown little resistance in vitro and to be safe and well tolerated in 800 patients with cancer treated for up to 6 wk .
OBJECTIVE	To determine the efficacy of iseganan for the prevention of ventilator-associated pneumonia ( VAP ) .
METHODS	Mechanically ventilated patients in the United States and Europe were randomized to oral topical iseganan or placebo ( 1:1 ) and treated six times per day while intubated for up to 14 d. Patients were eligible if randomized within 24 h of intubation and estimated to survive and remain mechanically ventilated for 48 h or more .
METHODS	The primary efficacy endpoint of the study was VAP measured among survivors at Day 14 .
RESULTS	A total of 709 patients were randomized and received at least one dose of study drug .
RESULTS	The two groups were comparable at baseline except iseganan-treated patients were , on average , 3 yr older .
RESULTS	The rate of VAP among survivors at Day 14 was 16 % ( 45/282 ) in patients treated with iseganan and 20 % ( 57/284 ) in those treated with placebo ( p = 0.145 ) .
RESULTS	Mortality at Day 14 was 22.1 % ( 80/362 ) in the iseganan group compared with 18.2 % ( 63/347 ) in the placebo group ( p = 0.206 ) .
RESULTS	No pattern of excess adverse events in the iseganan group compared with placebo was observed .
CONCLUSIONS	Iseganan is not effective in improving outcome in patients on prolonged mechanical ventilation .

###18591698
OBJECTIVE	Flurbiprofen axetil ( FA ) is a potent non-steroidal anti-inflammatory drug ( NSAID ) .
OBJECTIVE	We examined the effects that peri-operative intravenous administration of FA , combined with thoracic epidural anesthesia and postoperative patient-controlled epidural analgesia ( PCEA ) , have on bowel function , postoperative pain , and cytokine release , after open colorectal surgery .
METHODS	This was a prospective , randomized , double-blind , placebo-controlled study .
METHODS	Forty patients were randomly assigned to one of two groups ( n = 20 in each group ) .
METHODS	The FA group patients received FA 1 mg.kg ( -1 ) iv , 30 min before and six hours after skin incision ; whereas the control group patients received an equal volume of intralipid .
METHODS	Blood cytokine levels were measured before FA administration , at the end of surgery , and six hours and 24 hr postoperatively .
METHODS	All patients received postoperative PCEA for pain control .
METHODS	Analgesic efficacy was evaluated for 72 hr postoperatively using visual analogue scale ( VAS ) pain scores both at rest and during coughing .
METHODS	Gastrointestinal motility was recorded .
METHODS	Temperature and leukocyte count were measured preoperatively , and 24 hr postoperatively .
RESULTS	The times to first bowel movement ( 87 + / - 23 vs 105 + / - 19 hr , P = 0.008 ) and first flatus ( 63 + / - 16 vs 75 + / - 11 hr , P = 0.01 ) were earlier in the FA group compared to the control group .
RESULTS	For the first 24 hr , the pain scores in the FA group were also lower during coughing ( P < 0.001 compared to control ) .
RESULTS	The plasma concentrations of interleukin ( IL ) -6 and IL-8 in the FA group were lower , postoperatively ( P < 0.01 and P < 0.05 , respectively , compared to control ) .
RESULTS	In contrast , the IL-10 levels were significantly increased at six hours , postoperatively , in the FA group ( P = 0.009 ) .
RESULTS	The total leukocyte count and the incidence of pyrexia were also lower in patients of the FA group ( P = 0.001 and P = 0.006 , respectively , compared to control ) .
CONCLUSIONS	Flurbiprofen axetil may have an anti-inflammatory effect in major abdominal surgery .
CONCLUSIONS	The combination of perioperative intravenous FA , intraoperative thoracic epidural anesthesia , and postoperative PCEA facilitated recovery of bowel function , enhanced analgesia , and attenuated the cytokine response .

###7602352
OBJECTIVE	This phase III randomized trial was designed to determine if granulocyte-macrophage colony-stimulating factor ( GM-CSF ) reduces the hematologic toxicity and morbidity induced by chemoradiotherapy in limited-stage small-cell lung cancer ( SCLC ) .
METHODS	This multicenter prospective trial randomized 230 patients to receive chemotherapy and radiotherapy ( RT ) with or without GM-CSF given on days 4 to 18 of each of six cycles .
METHODS	The primary end point was hematologic toxicity .
METHODS	Secondary end points included the following : nonhematologic toxicities ; days of ( 1 ) fever , ( 2 ) antibiotics , ( 3 ) hospitalization , and ( 4 ) infection ; number of transfusions ; drug doses delivered ; and response rates and survival .
RESULTS	There was a statistically significant increase in the frequency and duration of life-threatening thrombocytopenia ( P < .001 ) in patients randomized to GM-CSF .
RESULTS	GM-CSF patients had significantly more toxic deaths ( P < .01 ) , more nonhematologic toxicities , more days in hospital , a higher incidence of intravenous ( IV ) antibiotic usage , and more transfusions .
RESULTS	Patients randomized to GM-CSF had higher WBC and neutrophil nadirs ( P < .01 ) , but no significant difference in the frequency of grade 4 leukopenia or neutropenia .
RESULTS	Patients randomized to GM-CSF had a lower complete response rate ( 36 % v 44 % ) , but the differences were not significant ( P = .29 ) .
RESULTS	There were no significant differences in survival ( median , 14 months on GM-CSF and 17 months on no GM-CSF ; P = .15 ) .
CONCLUSIONS	GM-CSF , as delivered in this study , should not be included with concurrent chemoradiotherapy treatment programs for limited-stage SCLC .
CONCLUSIONS	The simultaneous use of hematopoietic colony-stimulating factors ( CSFs ) and chemoradiotherapy should be performed only in experimental settings .
CONCLUSIONS	Chemoradiotherapy programs with cisplatin and etoposide ( [ VP-16 ] PE ) and simultaneous chest RT produce grade 4 neutropenia and thrombocytopenia in a small-enough proportion of patients that prophylactic hematopoietic growth factors are clinically unnecessary .

###15816811
BACKGROUND	Prader-Willi syndrome ( PWS ) is a multisystem genetic disorder characterized by short stature , muscular hypotonia , hyperphagia , obesity , maladaptive behaviour , hypogonadism and partial growth hormone ( GH ) deficiency ( GHD ) .
BACKGROUND	Severe GHD of other aetiologies has been shown to affect mood and quality of life negatively , and there are reports of improvements with GH replacement .
BACKGROUND	We have studied cognitive , emotional , physical and social parameters in PWS adults at baseline , during and after GH treatment .
METHODS	Nineteen patients , 9 females and 10 males , median age 25 years , mean BMI 35 kg/m2 participated in this study .
METHODS	Approximately half of the group had GHD .
METHODS	All patients fulfilled the clinical criteria for PWS and 13 had a positive genotype .
METHODS	The patients were randomized to 6 months of treatment with either GH [ 1.6 IU/day ( 0.53 mg/day ) ] or placebo , followed by 12 months of active GH treatment .
METHODS	Treatment was then stopped , and the patients were followed for an additional period of 6 months .
METHODS	A test battery for general cognitive evaluation and a computer-based measurement of reaction time , motor speed and fluency were employed at baseline , after 6 months and at the end of GH treatment .
METHODS	At the same time intervals , a self-evaluation questionnaire was answered at the end of each test session .
METHODS	Other questionnaires reflecting the patients ' cognitive , emotional , physical and social status were answered by relatives/caretakers at baseline and at 3 and 6 months following cessation of GH treatment .
RESULTS	Baseline cognitive level was estimated to be moderately to mildly impaired ; IQ range was 40-90 .
RESULTS	The results from some of the cognitive and the motor performance tests improved significantly after 6 and 18 months of GH treatment .
RESULTS	According to the questionnaires , both the patients and the relatives/caretakers evaluated physical status rather negatively at baseline , but still , impairments in both physical and social status and overall functioning were observed when GH treatment was discontinued .
RESULTS	The self-evaluation did not change in any aspect during GH treatment .
CONCLUSIONS	In this pilot study of an adult PWS cohort , we were able to document beneficial effects in mental speed and flexibility and in motor performance during GH treatment .
CONCLUSIONS	Impairment was seen in physical and social status as well as overall functioning , when GH treatment stopped .
CONCLUSIONS	Studies of larger cohorts are needed to further elucidate the role of GH treatment in this group of patients .

###17198647
OBJECTIVE	Torasemide is a high ceiling loop diuretic frequently used for treatment of heart failure , renal failure and hypertension , according to results mainly based on clinic blood pressure measurements , without proper evaluation of the 24-hour efficacy of the drug .
OBJECTIVE	Accordingly , we investigated the time-dependent antihypertensive efficacy of torasemide in hypertensive patients .
METHODS	We studied 58 patients with grade 1-2 essential hypertension ( 25 men and 33 women ) , 48.7 ( 11.9 ) years of age , randomly assigned to receive torasemide ( 5 mg/day ) either upon awakening or at bedtime .
METHODS	Blood pressure was measured by ambulatory monitoring for 48 consecutive hours before and after 6 weeks of therapy .
RESULTS	Efficacy of torasemide was significantly higher with bedtime dosing ( 11.2 and 8.0 mmHg reduction in the 24-hour mean of systolic and diastolic blood pressure , respectively ) as compared to the administration of the drug on awakening ( 6.2 and 3.7 mmHg reduction in systolic and diastolic blood pressure ) .
RESULTS	The percentage of patients with controlled ambulatory blood pressure after treatment was also higher after bedtime treatment ( 54 % versus 27 % ) .
RESULTS	The time-response curves indicate a full 24-hour therapeutic duration only when torasemide was administered before bedtime .
RESULTS	With regard to the safety profile , 2 patients presented secondary effects ( abdominal pain , diarrhea ) in morning dose , and 4 patients taking the drug at bedtime reported nicturia .
CONCLUSIONS	A dose of 5 mg/day torasemide is effective for blood pressure reduction after bedtime administration .
CONCLUSIONS	The differences in efficacy and therapeutic duration as a function of the circadian time of treatment with torasemide here documented should be taken into account when prescribing this loop diuretic for treatment of patients with essential hypertension .

###21995983
OBJECTIVE	Selective laser trabeculoplasty ( SLT ) and argon laser trabeculoplasty ( ALT ) are used to lower intraocular pressure ( IOP ) in patients with open-angle glaucoma ( OAG ) .
OBJECTIVE	We report long-term follow-up data comparing SLT to ALT .
METHODS	Follow-up of prospective randomized clinical trial .
METHODS	Patients with glaucoma from the practices of three ophthalmologists at the University of Ottawa .
METHODS	We randomized 176 eyes of 152 patients with uncontrolled IOP on maximal tolerated medical therapy ( MTMT , with or without previous ALT ) to undergo either SLT or ALT .
METHODS	Data were available for 142 eyes at 3 years , 134 eyes at 4 years , and 120 eyes at 5 years .
METHODS	The primary outcome was change in IOP from pretreatment baseline .
RESULTS	Comparison of baseline parameters was similar in the two groups .
RESULTS	Lowering of IOP were similar at 3 years ( SLT -6.7 7.1 vs ALT -6.1 5.1 ) ; at 4 years ( SLT 7.0 7.7 vs ALT -6.3 5.0 ) ; and at 5 years ( SLT -7.4 7.3 vs ALT -6.7 6.6 ) .
RESULTS	There was no statistically significant change in IOP in either of the two groups .
RESULTS	Medication changes were equivalent in each group .
RESULTS	A number of interventions were required in both groups , cumulatively , over the 5-year follow-up period ( 49 SLT and 33 ALT ) .
RESULTS	Survival analysis indicated that the time to 50 % failure in each group was approximately 2 years .
CONCLUSIONS	The IOP-lowering effect of SLT and ALT was similar over 5 years in this group of patients with open-angle glaucoma on MTMT .

###17399674
OBJECTIVE	To compare the posterior capsule opacification ( PCO ) inhibiting effect of the round anterior and sharp posterior optic edge profile of the Clariflex silicone intraocular lens ( IOL ) [ AMO Inc , Santa Ana , California , USA ] with that of the double-round edge profile of the SI40 ( Phacoflex ; AMO Inc , Santa Ana , California , USA ) silicone IOL over a period of three years .
METHODS	Prospective , randomized , double-masked , bilateral clinical trial .
METHODS	The study took place at the Department of Ophthalmology , Medical University of Vienna , Austria .
METHODS	Fifty-two patients with age-related cataracts ( 104 eyes ) were included in the study .
METHODS	Each patient received an SI40 IOL ( round edges ) in one eye and a Clariflex IOL with OptiEdge ( sharp posterior optic edge ) in the other eye .
METHODS	Follow-up examinations were at one week , one month , six months , and one , two , and three years .
METHODS	Digital retroillumination images were taken of each eye .
METHODS	The amount of PCO was subjectively assessed with the slit-lamp and objectively assessed by automated image analysis software ( the computer program Automated Quantification of After-Cataract [ AQUA ] ; Vienna , Austria ) one , two , and three years after surgery .
RESULTS	The Clariflex lens showed markedly less PCO at one , two , and three years after surgery .
RESULTS	The mean AQUA PCO score was 1.39 for the SI40 and 0.56 for the Clariflex lens after one year , estimated at 1.64 and 0.57 after two years , and at 2.04 and 0.64 , respectively , after three years ( scale zero to 10 ; P < .001 ) .
RESULTS	The Nd : YAG laser capsulotomy rate was far higher in the SI40 group ( Five cases vs one case at three years ) .
CONCLUSIONS	The sharp posterior optic edge profile of the Clariflex silicone IOL led to marked and consistently less PCO than the round-edged SI40 IOL one , two , and three years after surgery .

###23504930
BACKGROUND	The objective of this study was to assess the impact of a prostate-specific antigen ( PSA ) complete response ( PSA-CR ) , measured at the end of external-beam radiotherapy and short-term hormone therapy , on treatment outcomes .
METHODS	The phase 3 Radiation Therapy Oncology Group 9413 trial , as part of its original protocol , used the assessment of PSA-CR ( ie , PSA 0.3 ng/mL ) at the end of short-term HT as a secondary endpoint .
METHODS	Short-term HT consisted of futamide plus a lutenizing hormone-releasing hormone agonist for 4 months .
METHODS	The Kaplan-Meier method was used to estimate overall survival ( OS ) and disease-free survival .
METHODS	Cumulative incidence was used to estimate biochemical failure , distant metastasis , and disease-specific survival .
METHODS	Univariate and multivariate analyses were performed to correlate PSA-CR after short-term hormone therapy with all endpoints , and the following variables were considered for analysis : PSA at baseline , Gleason score , treatment arm , age , and baseline testosterone status .
METHODS	Phoenix consensus definition was used to define PSA failure .
RESULTS	For 1070 evaluable patients , the median PSA at the end of short-term hormone therapy was 0.2 ng/mL .
RESULTS	In total , 744 patients ( 70 % ) had a PSA-CR .
RESULTS	At a median follow-up of 7.2 years , failure to obtain a PSA-CR was associated significantly with worse disease-specific survival ( P = .0003 ; hazard ratio [ HR ] , 2.03 ; 95 % confidence interval [ CI ] , 1.38-2 .97 ) , with worse disease-free survival ( P = .003 ; HR , 1.28 ; 95 % CI , 1.09-1 .50 ) , and with a higher incidence of distant metastasis ( P = .0002 ; HR , 1.92 ; 95 % CI , 1.37-2 .69 ) and biochemical failure ( P < .0001 ; HR , 1.57 ; 95 % CI , 1.29-1 .91 ) .
RESULTS	Other factors that were associated with worse disease-specific survival were Gleason scores from 8 to 10 ( P = .0002 ; HR , 3.06 ; 95 % CI , 1.71-5 .47 ) and PSA levels > 20 ng/mL ( P = .04 ; HR , 1.55 ; 95 % CI , 1.02-2 .30 ) .
CONCLUSIONS	The current results indicated that failure to obtain a PSA-CR ( PSA 0.3 ng/mL ) after short-term hormone therapy and external-beam radiotherapy appears to be an independent predictor of unfavorable outcomes and could help identify patients who may benefit from the addition of long-term androgen ablation .

###23917308
BACKGROUND	Due to concerns of fragility fracture , exercise is a perceived contraindication for prostate cancer patients with bone metastases .
BACKGROUND	These patients experience significant functional impairment and muscle atrophy , which may lead to an increased likelihood of skeletal complicaTIOns ( i.e. , pathological fracture , bone pain ) and/or falls .
BACKGROUND	Safe resistance exercise prescription may counteract this effect .
BACKGROUND	The aim of this feasibility trial was to determine the safety and efficacy of resistance exercise by prostate cancer survivors with bone metastatic disease .
METHODS	Twenty men with established bone metastases secondary to prostate cancer were randomly assigned to a 12-week resistance exercise program in which exercise prescription was based on the location of bone lesions ( n = 10 ) or usual care ( n = 10 ) .
METHODS	Outcomes included safety and tolerance of the exercise program , physical function , physical activity level , body composition , fatigue , quality of life and psychological distress .
METHODS	Outcomes were compared between groups using analysis of covariance adjusted for baseline values .
RESULTS	Participants had significant disease load with 65 % of participants presenting with two or more regions affected by bone metastases and an average Gleason score of 8.20.9 .
RESULTS	Five participants ( exercise = 2 ; usual care = 3 ) did not complete the intervention , three of which were due to advancing disease ( exercise = 2 ; usual care = 1 ) .
RESULTS	No adverse events or skeletal complications occurred during the supervised exercise sessions .
RESULTS	The exercise program was well tolerated as evidenced by high attendance ( 83 % ) and compliance rates ( 93 % ) , and the ability of the participants to exercise at an intensity within the target range for cancer survivors ( rating of perceived exertion = 13.81.5 ) .
RESULTS	The change in physical function ( muscle strength 11 % ; submaximal aerobic exercise capacity 5 % and ambulation 12 % ) , physical activity level ( 24 % ) and lean mass ( 3 % ) differed significantly between groups following the intervention , with favorable changes in the exercise group compared with the usual care group .
RESULTS	No significant between-group differences were observed for fatigue , quality of life or psychological distress .
CONCLUSIONS	This initial evidence involving a small sample size suggests that appropriately designed and supervised resistance exercise may be safe and well tolerated by prostate cancer patients with bone metastatic disease and can lead to improvements in physical function , physical activity levels and lean mass .
CONCLUSIONS	Future trials involving larger sample sizes are required to expand these preliminary findings .

###10945311
BACKGROUND	Budesonide is a glucocorticosteroid used in the treatment of , for example , inflammatory bowel diseases , with a recommended once-daily morning dosing regimen .
BACKGROUND	Ketoconazole is a potent inhibitor of the cytochrome P450 3A ( CYP3A ) activities and known to inhibit the elimination of drugs metabolized by CYP3A , including budesonide .
BACKGROUND	It is of therapeutic interest to know whether the influence of ketoconazole can be reduced by administration on an occasion different in time to CYP3A substrates .
METHODS	Eight healthy men completed this randomized , open crossover study that comprised three different periods .
METHODS	In period 1 , a single oral dose of 3 mg budesonide was given in the morning .
METHODS	In period 2 , a 200-mg ketoconazole tablet was administered once daily in the morning on 4 consecutive days .
METHODS	On the fourth day , 3 mg budesonide was administered at the same time as the ketoconazole .
METHODS	In period 3 , 200 mg ketoconazole was administered once daily in the evening on 4 consecutive days .
METHODS	On the fourth day , 3 mg budesonide was administered 12 hours before the ketoconazole .
METHODS	One-week washout periods separated the budesonide administrations .
RESULTS	The mean area under the plasma drug concentration-time curve [ AUC ( 0-24 ) ] for budesonide was increased by 6.5 times when it was given simultaneously with ketoconazole .
RESULTS	When the administrations of the two drugs were separated by 12 hours , the mean AUC ( 0-24 ) for budesonide was increased by only 3.8 times .
CONCLUSIONS	This study shows that the capability of ketoconazole to inhibit the elimination of budesonide is significantly reduced ( by 50 % ) by a 12-hour separation of the administration times .

###15592281
OBJECTIVE	We tested if fetal pulse oximetry in addition to electronic fetal monitoring ( CTG ) and scalp blood sampling improves the accuracy of fetal assessment and allows safe reduction of operative deliveries ( -50 % ) and scalp blood sampling ( -50 % ) performed because of nonreassuring fetal status .
OBJECTIVE	Study design A randomized controlled trial was conducted in 146 patients with term pregnancies in active labor and abnormal fetal heart rate patterns : 73 had electronic fetal heart rate monitoring ( CTG ) and fetal scalp blood sampling ( control group ) , 73 had CTG , fetal scalp blood sampling , and continuous fetal pulse oximetry ( study group ) .
RESULTS	There was a reduction of -50 % in operative deliveries and fetal scalp blood sampling performed because of nonreassuring fetal status in the study group : operative deliveries , study versus control 25/49 ( P < / = .001 ) ; fetal scalp sampling , study versus control 32/64 ( P < / = .001 ) .
RESULTS	An increase in cesarean sections because of dystocia in the study group did not change the net number of operative deliveries .
RESULTS	There was no difference between the 2 groups in adverse maternal or neonatal outcomes , as well as for the end points of metabolic acidosis and need for resuscitation .
CONCLUSIONS	There was a safe reduction in operative deliveries ( -50 % ) and scalp blood sampling ( -50 % ) performed because of nonreassuring fetal status .
CONCLUSIONS	The increase in cesarean sections because of dystocia in the study group was a well-documented arrest of labor , but it did not change the total number of operative deliveries in this group .

###24776754
OBJECTIVE	Growth Hormone ( GH ) dosage in childhood is adjusted for body size , but there is no consensus whether body weight ( BW ) or body surface area ( BSA ) should be used .
OBJECTIVE	We aimed at comparing the biological effect and cost-effectiveness of GH treatment dosed per m2 BSA in comparison with dosing per kg BW in girls with Turner syndrome ( TS ) .
METHODS	Serum IGF-I , GH dose , and adult height gain ( AHG ) from girls participating in two Dutch and five Swedish studies on the efficacy of GH were analyzed , and the cumulative GH dose and costs were calculated for both dose adjustment methods .
METHODS	Additional medication included estrogens ( if no spontaneous puberty occurred ) and oxandrolone in some studies .
RESULTS	At each GH dose , the serum IGF-I standard deviation score remained stable over time after an initial increase after the start of treatment .
RESULTS	On a high dose ( at 1 m2 equivalent to 0.056-0 .067 mg/kg/day ) , AHG was at least equal on GH dosed per m2 BSA compared with dosing per kg BW .
RESULTS	The cumulative dose and cost were significantly lower if the GH dose was adjusted for m2 BSA .
CONCLUSIONS	Dosing GH per m2 BSA is at least as efficacious as dosing per kg BW , and is more cost-effective .

###15615131
OBJECTIVE	To investigate the efficacy of the anterior repositioning splint and the canine-protected splint in relieving the signs and symptoms of anterior disc displacement with reduction , and to evaluate the effects of both splints on disc position using a standardized magnetic resonance imaging measurement technique .
METHODS	A sample of 18 adult subjects was studied .
METHODS	The joint disorder was dually diagnosed via pretreatment clinical examination and magnetic resonance imaging .
METHODS	The sample was randomly divided into two groups .
METHODS	In the first group , each subject received an anterior repositioning splint ; in the second group , each subject received a canine-protected splint .
METHODS	The treatment lasted 3 months .
METHODS	A standardized magnetic resonance imaging 10-step procedure was developed .
METHODS	Posttreatment clinical examinations and magnetic resonance imagings were done .
METHODS	Pretreatment and posttreatment records were statistically compared .
CONCLUSIONS	Both types of splints were effective in eliminating pain and clicking .
CONCLUSIONS	All magnetic resonance imaging measurements showed that the canine-protected splint was superior to the anterior repositioning splint , as it allowed the articular disc to resume its normal length and shape while moving in a posterior direction toward recapture .
CONCLUSIONS	Disc recapture was demonstrated via magnetic resonance imaging in 25 % of the subjects from the anterior repositioning splint group , in 40 % of the subjects from the canine-protected splint group , and in 33.3 % of the subjects from both groups .
CONCLUSIONS	Thus , noninvasive treatment techniques ( such as occlusal splint therapy ) might be the treatment of choice for anterior disc displacement with reduction .

###22129890
OBJECTIVE	This open-label phase II trial assessed mitoxantrone/prednisone ( M/P ) with and without siltuximab ( CNTO 328 ) , an anti-interleukin-6 chimeric monoclonal antibody , for patients with metastatic castration-resistant prostate cancer who received prior docetaxel-based chemotherapy .
METHODS	Part 1 assessed the safety of biweekly siltuximab 6 mg/kg plus M 12 mg/m ( 2 ) every 3 weeks and P. Part 2 assessed efficacy and safety of siltuximab plus M/P versus M/P alone .
METHODS	The primary end-point was progression-free survival ( PFS ) .
METHODS	Progression was defined as progressive disease per Response Evaluation Criteria in Solid Tumours ( RECIST ) , or 3 new skeletal lesions with clinical deterioration or without deterioration confirmed by repeated bone scan .
METHODS	Rising prostate-specific antigen was not considered progression .
RESULTS	Siltuximab plus M/P was well tolerated in Part 1 ( n = 9 ) .
RESULTS	In Part 2 , 48 and 49 patients received siltuximab plus M/P or M/P alone , respectively .
RESULTS	Enrolment was prematurely terminated by the Independent Data Monitoring Committee since an apparent imbalance in patient baseline characteristics ( favoring the M/P only arm ) made it unlikely that the study could achieve its primary efficacy end-point .
RESULTS	Median PFS was 97 days with siltuximab combination and 228 days with M/P alone ( hazard ratio , 1.72 ; P = 0.043 ) .
RESULTS	Use of a novel non-validated PFS definition may have contributed to this result .
RESULTS	Abnormal laboratory assessments were more frequent with the combination .
RESULTS	Infection and febrile neutropenia rates were similar between groups .
RESULTS	Greater C-reactive protein suppression was achieved during siltuximab combination treatment compared with M/P alone ( P = 0.0003 ) .
CONCLUSIONS	While siltuximab plus M/P appeared well tolerated , improvement in outcomes was not demonstrated .

###10636276
OBJECTIVE	The purpose of the present study was to compare the long-term clinical and echocardiographic results of the Inoue and the double-balloon techniques .
BACKGROUND	The large randomized trial comparing the extent of commissurotomy and the long-term results between the double-balloon and Inoue balloon techniques has not been reported .
METHODS	We conducted a prospective , randomized trial comparing two procedures in 302 consecutive patients who underwent percutaneous mitral valvuloplasty ( PMV ) using Inoue ( n = 152 ; group I ) or double-balloon technique ( n = 150 , group D ) between 1989 and 1995 .
METHODS	The sample size was planned to provide the study with approximately 80 % power for the detection of a 10 % difference between the two groups .
RESULTS	There were no significant differences in baseline characteristics between the two groups .
RESULTS	Immediately after PMV , mitral valve area ( MVA ) increased from 0.9 + / - 0.2 to 1.8 + / - 0.3 cm2 in group I and from 0.9 + / - 0.2 to 1.9 + / - 0.3 cm2 in group D. No significant differences existed between the two groups in terms of development of commissural splitting , commissural mitral regurgitation ( CMR ) , moderate to severe mitral regurgitation ( MR ) and MVA after PMV .
RESULTS	The successful immediate results ( MVA > or = 1.5 cm2 and MR < or = 2 ) were achieved in 127 ( 84 % ) patients of group I and 122 ( 81 % ) patients of group D ( p = NS ) .
RESULTS	Annual clinical and echocardiographic evaluation was completed for 290 ( 96 % ) patients with mean follow-up of 51 + / - 27 months .
RESULTS	Adverse events occurred in 19 ( 13 % ) patients of group I ( 3 deaths , 7 mitral valve replacements , 5 repeat PMV , 2 NYHA class > or = 3 , 2 technical failures ) and 16 ( 11 % ) patients of group D ( 2 deaths , 10 mitral valve replacements , 3 repeat PMV , 1 NYHA class > or = 3 ) .
RESULTS	Estimated actuarial seven-year event-free survival was 75 + / - 7 % in group I and 82 + / - 6 % in group D ( p = NS ) .
RESULTS	Estimated actuarial seven-year restenosis-free survival was 67 + / - 7 % in group I and 76 + / - 6 % in group D ( p = NS ) .
RESULTS	On multivariate analysis , unsuccessful immediate result ( p < 0.001 ) and absence of CMR ( p < 0.01 ) were independently related with events .
RESULTS	Absence of CMR and smaller mitral valve area after PMV were independently related with restenosis ( p < 0.001 ) .
CONCLUSIONS	The Inoue and double-balloon techniques were equally effective in commissurotomy and produced similar , excellent long-term results .
CONCLUSIONS	The achievement of complete commissurotomy with development of CMR or larger post-PMV mitral valve area is important to optimize the long-term results of PMV .

###25563714
BACKGROUND	Methotrexate is a commonly used anti-inflammatory and immunosuppressive drug .
BACKGROUND	There is growing evidence that inflammatory processes are involved in the pathogenesis of schizophrenia .
BACKGROUND	In our recent randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil , the addition of minocycline ( antibiotic and anti-inflammatory drug ) for 1year to treatment as usual reduced negative symptoms and improved some cognitive measures .
BACKGROUND	A meta-analysis of cytokine changes in the peripheral blood has identified IL-2 , IFN-gamma , TNF-alpha and soluble IL-2 receptor as trait markers of schizophrenia because their levels were elevated during acute exacerbations and reduced in remission .
BACKGROUND	This suggests immune activation and an inflammatory syndrome in schizophrenia .
BACKGROUND	Based on the evidence of the strong anti-inflammatory properties of methotrexate , we propose that low-dose methotrexate may be an effective therapy in early schizophrenia .
METHODS	This is a double-blind placebo-controlled study of methotrexate added to treatment as usual for patients suffering from schizophrenia , schizoaffective disorder , psychosis not otherwise specified or schizophreniform disorder .
METHODS	This will be with 72 patients , 36 in each arm over 3months .
METHODS	There will be screening , randomisation and follow-up visits .
METHODS	Full clinical assessments will be carried out at baseline , 2 , 4 , 8 and 12weeks .
METHODS	Social and cognitive assessments will be carried out at baseline and 12weeks .
METHODS	Methotrexate will be given at a dose of 10 mgs orally once a week for a 3-month period .
CONCLUSIONS	Evidence suggests inflammatory processes are involved in the pathogenesis of schizophrenia and anti-inflammatory treatments have shown to have some beneficial effects .
CONCLUSIONS	Methotrexate is a known immunosuppressant and anti-inflammatory drug .
CONCLUSIONS	The aim of this study is to establish the degree of improvement in positive and negative symptoms , as well as cognitive functioning with the addition of methotrexate to treatment as usual.ClinicalTrials.gov identifier : NCT02074319 ( 24 February 2014 ) .

###16107602
BACKGROUND	To clarify clinical arguments regarding nutrition support in patients with long-term mechanical ventilation , we investigated the effects of hypercaloric feeding on nutrition status and carbon dioxide production .
METHODS	Twenty-eight mechanically ventilated , clinically stable patients with nasogastric tube feeding were recruited and randomly divided into the control and hypercaloric groups , which were provided with 1.2 - and 1.8-fold of resting energy expenditure ( REE ) , respectively .
METHODS	The arterial and venous blood samples were collected , the anthropometric measurements were determined , the serum concentrations of nutrition-related proteins were measured , and the parameters on the ventilator and indirect calorimeter were recorded on weeks 0 , 2 , and 4 .
RESULTS	There were no significant changes in anthropometric measurements , blood gas tensions , and REE between the control and hypercaloric groups during the experimental period ( mixed model with repeated measures analysis , p < .05 ) .
RESULTS	After adjusted for values on week 0 and time , patients with hypercaloric feeding had significantly increased levels in white blood cells , hemoglobin , and hematocrit .
RESULTS	However , the control group had significantly decreased and the hypercaloric group had significantly increased serum concentrations of prealbumin and transferrin , rate of carbon dioxide production , and respiratory quotient ( RQ ) from week 0 to week 4 .
CONCLUSIONS	Our results suggest that 4 weeks of hypercaloric feeding may significantly increase the production of carbon dioxide but may not significantly alter the clinical outcomes in patients with long-term mechanical ventilation .
CONCLUSIONS	The adverse effects of hypercaloric feeding may easily be overlooked , and the appropriateness of nutrition support should be carefully monitored in patients with mechanical ventilation .

###17666627
OBJECTIVE	To compare anterior colporrhaphy with and without a tailored mesh .
METHODS	Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were randomly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh .
METHODS	The low-weight monofilament polypropylene mesh was self-tailored , having four arms and being placed over the plicated fascia .
METHODS	Before and 2 and 12 months after surgery , participants were evaluated by physical examination , postvoidal residual urine measurement and standard questions covering prolapse-related symptoms .
METHODS	The primary outcome was recurrence of anterior vaginal prolapse at 12 months .
METHODS	Secondary outcomes included operative complications , symptom resolution , and postvoidal urine residual volume .
RESULTS	Of the 202 women randomly assigned , 201 were operated on ( 97 without , 104 with mesh ) .
RESULTS	Thirty-seven women ( 38.5 % ) in the no-mesh and seven ( 6.7 % ) in the mesh group experienced a recurrence of anterior wall prolapse ( P < .001 ) at 12 months ; as a result , the number needed to treat for benefit was four .
RESULTS	The mean ( standard deviation ) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation : 25 ( 26 ) mL and 41 ( 57 ) mL ( P = .01 ) .
RESULTS	Twenty-three women ( 23 % ) with mesh and 9 ( 10 % ) with no mesh reported stress urinary incontinence ( P = .02 ) .
RESULTS	In 18 ( 17.3 % ) , exposure of the mesh was noted , mainly asymptomatic .
CONCLUSIONS	Anterior colporrhaphy , reinforced with , tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation , but was associated more often with stress urinary incontinence .

###17892539
BACKGROUND	Whilst laterally wedged insoles , worn inside the shoes , are advocated as a simple , inexpensive , non-toxic self-administered intervention for knee osteoarthritis ( OA ) , there is currently limited evidence to support their use .
BACKGROUND	The aim of this randomised , double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain , physical function and health-related quality of life , and slower structural disease progression as well as being more cost-effective , than control flat insoles in people with medial knee OA .
METHODS	Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation .
METHODS	Participants will be blinded as to which insole is considered therapeutic .
METHODS	Blinded follow up assessment will be conducted at 12 months after randomisation .
METHODS	The outcome measures are valid and reliable measures recommended for OA clinical trials .
METHODS	Questionnaires will assess changes in pain , physical function and health-related quality-of-life .
METHODS	Magnetic resonance imaging will measure changes in tibial cartilage volume .
METHODS	To evaluate cost-effectiveness , participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis .
METHODS	To test the effect of the intervention using an intention-to-treat analysis , linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics .
CONCLUSIONS	Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA .
BACKGROUND	ACTR12605000503628 ; NCT00415259 .

###20049949
BACKGROUND	Mesalamine has been used as the first-line medication for the treatment of ulcerative colitis ( UC ) .
BACKGROUND	We directly compared the efficacy and safety of two different mesalamine formulations in the maintenance of remission in patients with UC .
METHODS	In a multicenter , double-blind , randomized study , 131 patients with quiescent UC were assigned to two groups : 65 to receive a pH-dependent release formulation of mesalamine at 2.4 g/day ( pH-2 .4 g ) and 66 to receive a time-dependent release formulation of mesalamine at 2.25 g/day ( Time-2 .25 g ) .
METHODS	Both formulations were administered three times daily for 48 weeks .
METHODS	The primary endpoint was the proportion of patients without bloody stools .
RESULTS	In the full analysis set ( n = 130 ) , the proportion of patients without bloody stools was 76.9 % in the pH-2 .4 g and 69.2 % in the Time-2 .25 g , demonstrating the noninferiority of pH-2 .4 g to Time-2 .25 g. No statistically significant difference in time to bloody stools was found between the two formulations ( P = 0.27 , log-rank test ) , but the time to bloody stools tended to be longer in pH-2 .4 g compared to Time-2 .25 g , and a similar trend was observed with regard to the time to relapse .
RESULTS	No differences were observed between the safety profiles of the two formulations .
CONCLUSIONS	The pH - and time-dependent release of mesalamine formulations were similarly safe and effective .
CONCLUSIONS	Interestingly , the remission phase tended to be longer in the group that received the pH-dependent formulation compared to the group that received the time-dependent formulation ( UMIN Clinical Trials Registry , no .
CONCLUSIONS	C000000289 ) .

###21835486
OBJECTIVE	To examine the effects of glibenclamide and repaglinide on glucose stimulated insulin release , incretins , oxidative stress and cell adhesion molecules in patients with type 2 diabetes suboptimally treated with metformin .
METHODS	A randomized clinical trial was performed recruiting 27 subjects ( HbA ( 1c ) between 7.5 and 10.5 % ) free from cardiovascular and renal disease .
METHODS	Glucose , insulin , C-peptide , glucagon-like peptide-1 ( GLP-1 ) , glucose-dependent insulinotropic peptide ( GIP ) , total antioxidant status , F ( 2 ) - isoprostane , interleukin-6 and cell adhesion molecules were measured during an oral glucose load at baseline and after eight weeks of treatment .
METHODS	The areas under the curve were analysed at 45 , 60 and 120 min ( AUC ( 45 ) , AUC ( 60 ) , AUC ( 120 ) ) .
RESULTS	Significant improvements in glucose were observed with repaglinide ( HBA ( 1c ) : -1.5 % , fasting glucose : -2.8 mmol/L , 2-h glucose : -3.7 mmol/L , AUC ( 120 ) : -18.9 % ) and glibenclamide ( -1.0 % , -2.2 mmol/L , -2.5 mmol/L , -17.5 % ) .
RESULTS	Repaglinide was also associated with an increase in the AUC ( 60 ) and AUC ( 120 ) for insulin ( +56 % , +61 % ) and C-peptide ( +41 % , +36 % ) .
RESULTS	GLP-1 , GIP , IL-6 , ICAM-1 and E-selectin levels did not change in either group .
RESULTS	No association was observed between GLP-1 , GIP-1 and plasma markers of oxidative stress .
CONCLUSIONS	Repaglinide is associated with improved postprandial glycaemic control via insulin and C-peptide release .
CONCLUSIONS	We observed no direct effects of glibenclamide or repaglinide on plasma levels of GLP-1 or GIP .
CONCLUSIONS	We observed no associations of GLP-1 and GIP with plasma markers of oxidative stress .

###1575787
OBJECTIVE	We previously reported that monthly telephone contact by lay personnel , to promote self-care for patients with osteoarthritis ( OA ) , was associated with improved joint pain and physical function after 1 year of followup .
OBJECTIVE	The present study was a secondary analysis to determine whether improvement was contingent on intensified medical treatment .
METHODS	We reanalyzed control/treatment group differences in all 40 subjects with radiographically confirmed knee OA who had had no changes in antirheumatic drug therapy or institution of physical therapy during the period of observation .
RESULTS	Group differences in measured pain remained significant ( effect size [ ES ] = 0.65 SD , P less than 0.01 ) .
RESULTS	The same trend was observed for physical function ( ES = 0.53 SD , P not significant ) .
CONCLUSIONS	The findings in this reanalysis suggest that periodic telephone support interventions are effective enough to be regarded as an adjunctive treatment for OA .

###22749223
OBJECTIVE	To investigate the effect of stopping progesterone ( P ) support at week 5 versus week 8 on ongoing pregnancy rate after in vitro fertilization ( IVF ) / intracytoplasmic sperm injection ( ICSI ) .
METHODS	Prospective , randomized , controlled trial .
METHODS	University-affiliated infertility center .
METHODS	A total of 220 patients with intrauterine pregnancy demonstrated by transvaginal ultrasound after IVF/ICSI .
METHODS	Luteal phase support with micronized vaginal P was suspended at week 5 or at week 8 .
METHODS	Ongoing pregnancy rate , miscarriage rate , and number of bleeding episodes .
RESULTS	Progesterone levels were similar on the day of the first pregnancy ultrasound exam ( 149 108 vs. 167 115 ng/mL ) .
RESULTS	Significantly more bleeding episodes were observed in the first trimester in the group with early cessation of P supplementation ( 18.0 2.6 vs. 7.2 1.3 episodes ) .
RESULTS	Miscarriage rates among singleton pregnancies were similar in the two groups ( 5/80 vs. 6/79 ) .
CONCLUSIONS	Vaginal P supplementation after IVF/ICSI can be safely withdrawn at 5 weeks ' gestation , because cycle outcome was similar to conventional luteal phase support up to 8 weeks of pregnancy .
BACKGROUND	NCT01177904 .

###16503773
OBJECTIVE	The aim of this study was to evaluate the effect of preoperative topical latanoprost , bimatoprost , and travoprost administration on postoperative intraocular pressure ( IOP ) after phacoemulsification and posterior chamber intraocular lens ( PC IOL ) implantation .
METHODS	This prospective , randomized , double-masked study included 120 eyes of 120 consecutive , normotensive , uncomplicated cataract patients having phacoemulsification surgery with PC IOL implantation .
METHODS	They were randomized into 1 of 4 treatment groups , each of which had 30 patients .
METHODS	Two ( 2 ) h before the surgery , the patients received 0.005 % latanoprost ( Group 1 ) , 0.004 % bimatoprost ( Group 2 ) , 0.03 % travoprost ( Group 3 ) , or placebo ( Group 4 , artificial tears ) .
METHODS	IOP was measured at preoperative , 4 , 8 , and 24 h postoperative with a Goldmann applanation tonometer .
METHODS	The anterior chamber was examined postoperatively 24 h for levels of cell and flare using slit-lamp biomicroscopy .
RESULTS	The preoperative mean IOP was not statistically significant different among the four groups .
RESULTS	In Groups 1 and 3 , the mean IOP at 4 , 8 and 24 h were significantly lower than the control ( Group 4 ; P < 0.05 ) .
RESULTS	However , in Group 2 , there was no significant difference in IOP during the study period , compared to the control ( Group 4 ; P > 0.05 ) .
RESULTS	In addition , the mean postoperative IOP at 24 h in Groups 1 and 3 were significantly lower than the preoperative IOP ( P < 0.05 ) .
RESULTS	No severe anterior chamber reaction was observed in any group .
CONCLUSIONS	Our findings show that a single-dose topical of latanoprost and travoprost can prevent early postoperative IOP elevation after phacoemulsification surgery without any sideeffects .

###23849965
BACKGROUND	Elevated heart rate ( HR ) is associated with mortality in a number of heart diseases .
BACKGROUND	We examined the long-term prognostic significance of HR at discharge in a contemporary population of patients with stable angina ( SAP ) , non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) , and ST-segment elevation myocardial infarction ( STEMI ) revascularized with percutaneous coronary intervention ( PCI ) .
METHODS	Patients from the BASKET-PROVE trial , an 11-center randomized all-comers trial comparing bare-metal and drug-eluting stenting in large coronary vessels , were included .
METHODS	Discharge HR was determined from a resting ECG .
METHODS	Long-term outcomes ( 7 days to 2 years ) were evaluated for all-cause mortality and cardiovascular death and non-fatal myocardial infarction .
RESULTS	A total of 2029 patients with sinus rhythm were included , 722 ( 35.6 % ) SAP , 647 ( 31.9 % ) NSTE-ACS , and 660 ( 32.5 % ) STEMI .
RESULTS	Elevated discharge HR was associated significantly with all-cause mortality : when compared to a reference of < 60 beats per minute ( bpm ) , the adjusted hazard ratios were ( 95 % CI ) 4.5 ( 1.5-13 .5 , p = 0.006 ) for 60-69 bpm , 3.8 ( 1.2-11 .9 , p = 0.022 ) for 70-79 bpm , 4.3 ( 1.2-15 .6 , p = 0.025 ) for 80-89 bpm , and 16.9 ( 5.2-55 .0 , p < 0.001 ) for > 90 bpm .
RESULTS	For cardiovascular death/myocardial infarction , a discharge HR > 90 bpm was associated with a hazard ratio of 6.2 ( 2.5-15 .5 , p < 0.001 ) compared to a HR < 60 bpm .
RESULTS	No interaction was found for disease presentation , diabetes or betablocker use .
CONCLUSIONS	In patients revascularized with PCI for stable angina or acute coronary syndromes an elevated discharge HR was independently associated with poor prognosis .
CONCLUSIONS	Conversely , a HR < 60 bpm at discharge was associated with a good long-term prognosis irrespective of indication for PCI .

###24636035
OBJECTIVE	To evaluate the effect of tobacco cessation brief-intervention ( BI ) training for lay `` health influencers , '' on knowledge , self-efficacy and the proportion of participants reporting BI delivery post-training .
METHODS	Randomized , community-based study comparing In-person or Web-based training , with mailed materials .
RESULTS	In-person and Web-training groups had significant post-training cessation knowledge and self-efficacy gains .
RESULTS	All groups increased the proportion of individuals reporting BIs at follow-up , with no significant between-group differences .
RESULTS	Irrespective of participants ' prior intervention experience , 80 % -86 % reported BIs within the past 90 days ; 71 % -79 % reported > 1 in the past 30 .
CONCLUSIONS	Web and In-person training significantly increase health influencer cessation knowledge and self-efficacy .
CONCLUSIONS	With minimal prompting and materials , even persons without BI experience can be activated to encourage tobacco cessation .

###15756184
OBJECTIVE	To study the effects of 3 different intra-articular analgesic combinations on postoperative pain , and whether the timing of the injection , either preoperative or postoperative , had an effect on postoperative analgesia .
METHODS	Prospective , randomized , double-blind clinical trial .
METHODS	Patients undergoing knee arthroscopy performed by a single surgeon under general anesthesia were randomized into 6 study groups .
METHODS	Each patient received an intra-articular injection 20 minutes before incision and at the end of the procedure .
METHODS	One injection contained the study medications , and the other contained normal saline solution ( placebo ) .
METHODS	The patients , surgeon , and data collection personnel were blinded to the contents of the injections .
METHODS	Outcome measures included visual analogue pain scores at 0 , 60 , and 120 minutes after the procedure , and total recovery room fentanyl consumption .
RESULTS	Fifty patients successfully completed the study protocol .
RESULTS	Patients receiving combinations of morphine , bupivacaine , and epinephrine or bupivacaine and epinephrine yielded lower pain scores and narcotics consumption than patients receiving epinephrine alone , which was statistically significant irrespective of the timing of injection ( P < .0001 ) .
RESULTS	Patients receiving the study medication preoperatively had significantly lower pain scores at the first measurement ( t = 0 ) than those receiving the study medication postoperatively ( P = .0343 ) .
RESULTS	There was no statistically significant effect of timing of the treatment medication administration at either 60 or 120 minutes postoperatively .
RESULTS	Comparison of fentanyl consumption between groups receiving the treatment medication preoperatively versus postoperatively showed no significant difference .
CONCLUSIONS	The combination of morphine , bupivacaine , and epinephrine , as well as the combination of bupivacaine and epinephrine provide excellent postoperative pain control when used either preoperatively or postoperatively in knee arthroscopy .
CONCLUSIONS	There was a trend that patients receiving preoperative analgesic injections experienced superior pain control than did those injected postoperatively .
METHODS	Level I , Randomized Controlled Trial .

###9041301
OBJECTIVE	To use social learning theory to develop and examine the effectiveness of a 15-minute , culturally sensitive videotape in altering mealtime communication and attitudes among African-American adolescent mothers .
METHODS	Randomized clinical trial with baseline and follow-up evaluations .
METHODS	High schools , WIC ( Women , Infants , and Children ) Clinics , and Family Support Centers serving low-income families .
METHODS	Fifty-nine first-time , African-American adolescent mothers of infants .
METHODS	Intervention group viewed and received a copy of a videotape titled `` Feeding Your Baby With Love . ''
METHODS	The messages , title , music , and setting were designed by an advisory group of six African-American adolescent mothers who were filmed feeding their infants in their homes .
RESULTS	During baseline and follow-up evaluations , mothers were videotaped feeding their baby and completed a questionnaire on attitudes toward mealtime behavior .
RESULTS	Analysis of covariance with repeated measures indicated changes in both behavior and attitudes .
RESULTS	At follow-up , intervention mothers were more involved with their infant and reported more favorable attitudes toward feeding and communication than control mothers .
CONCLUSIONS	Brief culturally sensitive videotapes may be effective strategies to promote parenting skills and to prevent social and health problems among adolescents .

###19368788
BACKGROUND	Many strategies , including intradermal vaccination , have been tested to augment antibody responses upon vaccination .
BACKGROUND	This strategy has not been evaluated in different groups of immunocompromized patients .
BACKGROUND	We conducted a prospective , randomized study to compare the humoral response upon standard intramuscular influenza vaccination with the response upon reduced-dose intradermal vaccination in patients treated with anti-tumor necrosis factor ( TNF ) - alpha , human immunodeficiency virus ( HIV ) - infected patients , hematologic stem cell transplantation ( HSCT ) patients , and healthy controls .
METHODS	In total 156 immunocompromized patients and 41 healthy controls were randomized to receive either 0.5 mL of the 2005/2006 trivalent influenza vaccine intramuscular or 0.1 mL intradermal .
METHODS	Humoral responses , determined by hemagglutination inhibition assay , were measured before and 28 days postvaccination .
METHODS	Geometric mean titers ( GMTs ) and protection rates ( PRs ) are reported as primary outcomes , adverse events as a secondary outcome .
RESULTS	Reduced-dose intradermal vaccination leads to similar GMTs and PRs , within all tested groups , compared to the standard intramuscular vaccination .
RESULTS	Healthy controls yielded significantly better GMTs and PRs than immunocompromized patients .
RESULTS	Local skin reactions after intradermal vaccination occurred less frequent and were milder in immunocompromized patients than in healthy subjects and were predictive for a positive vaccination outcome for individual subjects .
CONCLUSIONS	Intradermal influenza vaccination is a feasible alternative for standard intramuscular vaccination in several groups of immunocompromized patients , including those treated with anti-TNF , HIV-infected patients and HSCT patients .
CONCLUSIONS	The occurrence of a local skin reaction after intradermal vaccination is predictive of a response to at least one of the vaccine antigens .

###11586996
BACKGROUND	One of the major problems when evaluating dyspeptic patients at public hospitals is the large interval between the consultation and the endoscopy , leading to the prescription of antisecretory drugs , what can be responsible for false results on examinations .
OBJECTIVE	To evaluate changes in ultrarapid urease test and histopathological examination for Helicobacter pylori by antisecretory drugs .
METHODS	In a prospective double-blind study , 50 patients with dyspeptic complaints and endoscopic diagnosis of peptic ulcer , erosive gastritis , esophagitis or duodenitis with a positive urease test , were randomized to a 7-day course of treatment with either omeprazole 20 mg or ranitidine 300 mg a day .
METHODS	Before and after treatment , two biopsy specimens each were obtained from the antrum and corpus and an ultrarapid urease test and a histopathological examination for Helicobacter pylori were performed .
RESULTS	There were no significant changes in the results of ultrarapid urease test and histopathological examination for Helicobacter pylori after treatment with ranitidine .
RESULTS	With omeprazole , we observed a decrease in positive results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum , but not in the corpus .
CONCLUSIONS	Omeprazole , used for 7 days can lead to negative results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum , and should not be employed in patients before the endoscopy is performed .

###17305624
BACKGROUND	The present study was undertaken to evaluate the safety and effectiveness of a recently developed electrostimulating device mounted on an individualized intra-oral removable appliance .
METHODS	The device , containing electrodes , a wetness sensor , an electronic circuit and a power source , was tested on patients with xerostomia in a crossover , randomized , sham-controlled , double-blinded , multicenter study .
METHODS	Electrical stimulation and also sham were delivered during 10 min to the oral mucosa , in the mandibular third molar region .
METHODS	Oral dryness was measured by the sensor .
METHODS	As the primary outcome , sensor dryness and xerostomia symptom changes as a result of device wearing were assessed , and compared between active and sham modes .
METHODS	In addition , side-effects were recorded .
RESULTS	Electrostimulation resulted in a significant decrease in sensor dryness , leading to a beneficial effect on patients ' subjective condition .
RESULTS	No significant side-effects were observed .

###10021957
OBJECTIVE	To evaluate the effects of clonidine on responses to adrenoceptor agonists and baroreflex sensitivity , we examined arterial blood pressure ( AP ) responses to phenylephrine and heart rate ( HR ) responses to isoproterenol and baroreflex sensitivity ( HR response to AP changes due to phenylephrine or nitroglycerin ) .
METHODS	We studied 60 anaesthetized patients who either did or did not receive 5 micrograms.kg-1 clonidine po before they were anaesthetized .
METHODS	After induction of general anaesthesia , the patients received 3 micrograms.kg-1 phenylephrine , 0.02 microgram.kg-1 isoproterenol , or 2-3 micrograms.kg-1 nitroglycerin , and haemodynamic measurements were taken .
METHODS	Baroreflex sensitivity was expressed as the slope of the linear regression line ( msec.mmHg-1 ; in msec of R-R interval change vs mmHg change in systolic arterial pressure ) following the administration of phenylephrine and nitroglycerin .
RESULTS	Patients who received clonidine had greater augmented responses in AP to phenylephrine and in HR to isoproterenol ( 47.2 + / - 15.6 % vs 23.7 + / - 11.9 % for increase in systolic AP and 59.8 + / - 22.6 % vs 26.2 + / - 11.0 % for increase in HR , P < 0.05 respectively ) .
RESULTS	There were no differences between the baroreflex sensitivities in the pressor ( phenylephrine ) test groups ( 3.77 + / - 1.08 vs 4.41 + / - 1.66 msec.mmHg-1 ) .
RESULTS	In contrast , the slopes of depressor ( nitroglycerin ) test groups were decreased in patients receiving clonidine ( 1.98 + / - 0.73 vs 3.68 + / - 1.72 msec.mmHg-1 , P < 0.05 ) .
CONCLUSIONS	The results suggest that premedication with clonidine might enhance critical hypotension during anaesthesia and surgery , but restoration both of AP and HR decrease can be achieved effectively by phenylephrine and isoproterenol i.v. , respectively .

###8627642
BACKGROUND	The possible link between psychological factors and length of cancer survival has generated a literature of contradictory findings .
BACKGROUND	Associations usually have not been found when general psychological symptoms are assessed .
BACKGROUND	Associations usually have been found for predictors related to expressive versus repressive emotional coping ( e.g. , depression , `` fighting spirit , '' hostility , and type C personality ) ; however , even these associations have been relatively small , when compared with those for medical factors .
BACKGROUND	Yet few studies have adequately controlled for medical and treatment-related factors .
OBJECTIVE	Within a Cancer and Leukemia Group B ( CALGB ) national clinical trial of four adjuvant therapy regimens for stage II breast cancer ( CALGB 8082 ) , this study prospectively examined the contribution of potential psychological predictors to length of disease-free and overall survival over a 15-year period .
METHODS	Subjects were 280 women with stage II breast cancer , out of a total of 899 , who were randomly assigned to receive CMFVP ( cyclophosphamide-methotrexate-fluorouracil-vincristine-prednisone ) for two 6-week cycles or six 4-week cycles , then subsequently randomly assigned to receive or not to receive VATH ( vinblastine-doxorubicin-thiotepa-fluoxymesterone ) .
METHODS	Subjects were recruited during the period between October 1980 and August 1984 , inclusive , and followed until January 1996 .
METHODS	Prior to chemotherapy , psychological symptoms were assessed using the Symptom Check List-90-Revised ( SCL-90-R ) .
METHODS	SCL-90-R scores were trichotomized into categories representing high , medium , and low distress .
METHODS	Basic base-line sociodemographic data ( including age , ethnicity , education , and marital status ) and medical data ( including lymph node status , estrogen receptor status , menopausal status , and performance status ) were collected .
METHODS	Subjects with psychosocial data differed from those without psychosocial data solely in their higher percentage of classification in the mild limitation category of the Zubrod ( Eastern Cooperative Oncology Group ) performance status rating ( subjects with psychosocial data : 14 % ; subjects without psychosocial data : 8 % ) .
RESULTS	In stepwise Cox regression analyses that controlled for sociodemographic and medical variables , there was no significant predictive effect of the level of distress ( as measured by the SCL-90-R trichotomized scores ) on length of disease-free and overall survival of the study subjects .
RESULTS	Risk ratios for low versus high distress were 1.01 ( 95 % confidence interval [ CI ] = 0.62-1 .66 ) for disease-free survival and 1.03 ( 95 % CI = 0.58-1 .82 ) for overall survival .
CONCLUSIONS	This study failed to provide evidence that psychological factors contributed to length of disease-free or overall survival of women who received adjuvant chemotherapy ( either CMFVP alone or CMFVP followed by VATH ) for treatment of stage II breast cancer .
CONCLUSIONS	In the context of far more potent medical factors , the contribution of psychological factors to disease-free and overall survival is likely to be relatively small .
CONCLUSIONS	Future research should focus on specific theory-driven predictors rather than on general psychological symptoms .
CONCLUSIONS	Moreover , it should be based on clinical studies using a controlled , prospective design , in which the effects of medical factors may be distinguished and psychological predictors are clear antecedents of survival outcomes .

###16948990
OBJECTIVE	Magnesium sulfate has been shown to have a bronchodilating effect in asthma , but this effect has not been clearly established in the context of chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	For this reason we investigated the possible bronchodilating effect of magnesium sulfate in COPD exacerbations .
METHODS	We studied 24 patients with exacerbated COPD who required admission to our hospital 's pneumology department .
METHODS	All patients underwent baseline spirometry and were subsequently randomized to groups in a double-blind crossover design .
METHODS	Patients received 1.5 g of magnesium sulfate or placebo in an intravenous solution for 20 minutes .
METHODS	Those who received magnesium sulfate the first day were given placebo the second day , and vice versa .
METHODS	Spirometry was performed 15 , 30 , and 45 minutes after administration of magnesium sulfate or placebo .
METHODS	Finally , 400 microg of salbutamol were administered using a spacer and a final spirometry was performed 15 minutes later .
METHODS	All patients also received treatment with corticosteroids , intravenous antibiotics , oxygen , and regularly-scheduled bronchodilator therapy ( salbutamol and ipratropium bromide every 6 hours ) .
RESULTS	When we compared absolute increase in milliliters and percentage increase in forced expiratory volume in 1 second ( FEV1 ) obtained with magnesium sulfate application to the increases obtained with placebo after 15 , 30 , and 45 minutes , no significant differences were found .
RESULTS	When we compared absolute and percentage increases in FEV1 after administering salbutamol , we found significantly greater increases after magnesium sulfate administration .
RESULTS	The mean ( SD ) absolute increase in FEV1 was 0.18 [ corrected ] ( 0.42 ) L after magnesium sulfate administration and 0.081 [ 0.01 ] L after placebo ( P = .004 ) .
RESULTS	The percentage increase in FEV1 was 17.11 % ( 3.7 % ) after magnesium sulfate and 7.06 % ( 1.8 % ) after placebo ( P = .008 ) .
CONCLUSIONS	Intravenous administration of magnesium sulfate has no bronchodilating effect in patients with COPD exacerbations .
CONCLUSIONS	It does , however , enhance the bronchodilating effect of inhaled ss2-agonists .

###21168853
OBJECTIVE	To examine the long-term effects of fluconazole prophylaxis in extremely low birth weight infants .
METHODS	Neurodevelopmental status and quality of life of survivors from a randomized , placebo-controlled trial of fluconazole prophylaxis were evaluated at 8 to 10 years of life using the Vineland Adaptive Behavior Scales-II ( VABS-II ) and the Child Health Questionnaire Parent-Completed Form 28 ( CHQ-PF28 ) , respectively .
RESULTS	VABS-II Domain Scores for the fluconazole-treated ( n = 21 ; 9.1 0.7 years ) compared with the placebo group ( n = 17 ; 9.3 0.8 years ) were similar for communication [ 94.6 ( 14.8 ) versus 92.6 ( 12.6 ) , P = .65 ] , daily living skills [ 87.9 ( 10.6 ) versus 87.4 ( 9.3 ) , P = .89 ] , socialization [ 97.2 ( 9.2 ) versus 94.4 ( 7.9 ) , P = .31 ] , and motor skills [ 92.1 ( 17.8 ) versus 95.1 ( 14.6 ) , P = .57 ] .
RESULTS	Internalizing and externalizing behaviors and maladaptive behavior index were also similar .
RESULTS	The CHQ-PF28 revealed no differences between the two groups regarding quality of life .
RESULTS	Survivors were also happy or satisfied with school ( 90 % versus 100 % , P = .49 ) , friendships ( 90 % versus 88 % , P = 1.00 ) , and life ( 95 % versus 100 % , P = 1.00 ) .
RESULTS	Self esteem scores were 87.3 15.7 versus 89.7 10.4 ( P = .59 ) .
RESULTS	There were also no differences between groups regarding emotional difficulties or behavior problems .
CONCLUSIONS	Fluconazole prophylaxis for the prevention of invasive Candida infections is safe in extremely low birth weight infants and does not appear to be associated with any long-term adverse effects on neurodevelopment and quality of life at 8 to 10 years of life .

###21377341
OBJECTIVE	To compare the effects of volume-controlled ventilation ( VCV ) and pressure-controlled ventilation ( PCV ) on respiratory mechanics and hemodynamics in steep Trendelenburg position .
METHODS	Prospective , randomized clinical trial .
METHODS	University hospital .
METHODS	34 ASA physical status 1 and 2 patients undergoing RLRP .
METHODS	Patients were randomly allocated to either the VCV ( n = 17 ) or the PCV group ( n = 17 ) .
METHODS	After induction of anesthesia , each patient 's lungs were ventilated in constant-flow VCV mode with 50 % O ( 2 ) and tidal volume of 8 mL/kg ; a pulmonary artery catheter was then inserted .
METHODS	After establishment of 30 Trendelenburg position and pneumoperitoneum , VCV mode was switched to PCV mode in the PCV group .
METHODS	Respiratory and hemodynamic variables were measured at baseline supine position ( T1 ) , post-Trendelenburg and pneumoperitoneum 60 minutes ( T2 ) and 120 minutes ( T3 ) , and return to baseline after skin closure ( T4 ) .
RESULTS	The PCV group had lower peak airway pressure ( AP ( peak ) ) and greater dynamic compliance ( C ( dyn ) ) than the VCV group at T2 and T3 ( P < 0.05 ) .
RESULTS	However , no other variables differed between the groups .
RESULTS	Pulmonary arterial pressure and central venous pressure increased at T2 and T3 ( P < 0.05 ) .
RESULTS	Cardiac output and right ventricular ejection fraction were unchanged in both groups .
CONCLUSIONS	PCV offered greater C ( dyn ) and lower AP ( peak ) than VCV , but no advantages over VCV in respiratory mechanics or hemodynamics .

###12878628
BACKGROUND	Blood/gas partition coefficients ( lambda ( b/g ) ) for volatile agents in horse blood are reported for halothane but not for isoflurane and sevoflurane .
BACKGROUND	We measured the lambda ( b/g ) of halothane , isoflurane and sevoflurane in the blood of fasted horses .
BACKGROUND	The correlation with age , weight and some haematological and biochemical variables was studied .
BACKGROUND	The temperature correction factor for isoflurane solubility was calculated .
METHODS	Twenty-four horses were randomly allocated to halothane ( n = 8 ) , isoflurane ( n = 8 ) or sevoflurane ( n = 8 ) .
METHODS	Blood samples were taken after 10 h ' fasting .
METHODS	Calculation of lambda ( b/g ) was based on the measurement of anaesthetic partial pressures in blood at 37 degrees C , which was achieved with tonometer equilibration and headspace gas chromatography .
RESULTS	Mean lambda ( b/g ) was 1.66 ( SD 0.06 ) for halothane , 0.92 ( 0.04 ) for isoflurane , and 0.47 ( 0.03 ) for sevoflurane .
RESULTS	The lambda ( b/g ) values were all significantly lower than in humans ( P < 0.001 ) .
RESULTS	No correlation was found between lambda ( b/g ) and weight , age , haematocrit , plasma triglycerides , cholesterol or total bilirubin .
RESULTS	The change in isoflurane solubility per 1 degrees C temperature increase was -2.63 ( 0.13 ) % .
CONCLUSIONS	The lambda ( b/g ) values of halothane , isoflurane and sevoflurane in fasted horses are significantly lower than those reported in humans .
CONCLUSIONS	The lambda ( b/g ) for halothane in this study agrees with values reported in the literature but a positive correlation with plasma triglycerides could not be confirmed .
CONCLUSIONS	Knowledge of lambda ( b/g ) can refine models of anaesthetic uptake .

###10383563
OBJECTIVE	To characterize the pharmacokinetics of amitriptyline and its metabolite nortriptyline following OROS and IR treatments , and to correlate them with anticholinergic side-effects .
METHODS	The pharmacokinetics and safety of amitriptyline following administration of an osmotic controlled release tablet ( OROS and an immediate release ( IR ) tablet were evaluated in 14 healthy subjects .
METHODS	In this randomized , open label , three-way crossover feasibility study , the subjects received a single 75 mg OROS tablet , three 25 mg IR tablets administered every 8 h , or 3x25 mg IR tablets administered at nighttime .
METHODS	In each treatment arm serial blood samples were collected for a period of 84 h after dosing .
METHODS	The plasma samples were analysed by gas chromatography for amitriptyline and its metabolite nortriptyline .
METHODS	Anticholinergic effects such as saliva output , visual acuity , and subject-rated drowsiness and dry mouth were measured on a continuous scale during each treatment period .
RESULTS	Following dosing with OROS ( amitriptyline hydrochloride ) , the mean maximal plasma amitriptyline concentration Cmax ( 15.3 ng ml-1 ) was lower and the mean tmax ( 25.7 h ) was longer than that associated with the equivalent IR dose administered at nighttime ( 26.8 ng ml-1 and 6.3 h , respectively ) .
RESULTS	The bioavailability of amitriptyline following OROS dosing was 95 % relative to IR every 8 h dosing , and 89 % relative to IR nighttime dosing .
RESULTS	The metabolite-to-drug ratios after the three treatment periods were similar , suggesting no change in metabolism between treatments .
RESULTS	The relationships between plasma amitriptyline concentration and anticholinergic effects ( e.g. reduced saliva weight , dry mouth , and drowsiness ) were similar with all three treatments .
RESULTS	Of the anticholinergic effects , only decreased saliva weight and dry mouth correlated well with plasma amitriptyline concentrations ; drowsiness did not .
RESULTS	There was no apparent correlation between anticholinergic effects and the plasma nortriptyline concentration .
CONCLUSIONS	The bioavailability of OROS ( amitriptyline hydrochloride ) was similar to that of the IR treatments and the pharmacokinetics of amitriptyline after OROS dosing may decrease the incidence of anticholinergic effects compared with that seen with nighttime dosing of the IR formulation .
CONCLUSIONS	Therefore , this controlled-release formulation of amitriptyline may be appropriate for single daily administration .

###9545357
BACKGROUND	Standard clinical practice permits the use of either single-chamber ventricular pacemakers or dual-chamber pacemakers for most patients who require cardiac pacing .
BACKGROUND	Ventricular pacemakers are less expensive , but dual-chamber pacemakers are believed to be more physiologic .
BACKGROUND	However , it is not known whether either type of pacemaker results in superior clinical outcomes .
METHODS	The Pacemaker Selection in the Elderly study was a 30-month , single-blind , randomized , controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers .
METHODS	Patients received a dual-chamber pacemaker that had been randomly programmed to either ventricular pacing or dual-chamber pacing .
METHODS	The primary end point was health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey .
RESULTS	The average age of the patients was 76 years ( range , 65 to 96 ) , and 60 percent were men .
RESULTS	Quality of life improved significantly after pacemaker implantation ( P < 0.001 ) , but there were no differences between the two pacing modes in either the quality of life or prespecified clinical outcomes ( including cardiovascular events or death ) .
RESULTS	However , 53 patients assigned to ventricular pacing ( 26 percent ) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome .
RESULTS	Patients with sinus-node dysfunction , but not those with atrioventricular block , had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing .
RESULTS	Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction , but not in those with atrioventricular block .
CONCLUSIONS	The implantation of a permanent pacemaker improves health-related quality of life .
CONCLUSIONS	However , the quality-of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction .

###8733090
BACKGROUND	In patients with postinfarction sustained ventricular tachycardia showing one or more antiarrhythmic drug failures , the question is how long to proceed with new drug trials before deciding to perform map-guided arrhythmia surgery .
BACKGROUND	Although the techniques of this surgery developed rapidly in the early 1980s , this therapy may be offset by damage to residual left ventricular function .
BACKGROUND	However , surgery has been shown to be very effective in selected groups of patients .
METHODS	A randomized study was carried out in patients with postinfarction ventricular tachycardia and eligible for arrhythmia surgery based on residual left ventricular function .
METHODS	Therapy failure was defined by the occurrence of the following events : spontaneous recurrence of ventricular tachycardia or ventricular fibrillation , sudden cardiac death , inducibility of sustained ventricular tachycardia or ventricular fibrillation with programmed stimulation of the heart , symptomatic non-sustained ventricular tachycardia requiring therapy or side-effects of antiarrhythmic drugs requiring withdrawal .
METHODS	In the drug limb , failure of the first antiarrhythmic drug was accepted but failure of a second and different drug was regarded as true therapy failure .
RESULTS	After randomization , antiarrhythmic drug therapy was administered in 33 patients , and 30 patients underwent surgery .
RESULTS	Neither group differed in baseline characteristics , and the mean number of drug failures before randomization was 2.7 .
RESULTS	The Kaplan-Meier therapeutic failure of antiarrhythmic drugs was 39 + / - 11 % , 42 + / - 11 % and 51 + / - 18 % at 0.5 - , 1 - and 4-year follow-up , respectively , whereas the therapeutic failure of cardiac surgery was 37 + / - 11 % , 37 + / - 11 % and 50 + / - 20 % at 0.5 , 1 and 4 years , respectively , showing no statistical difference .
RESULTS	The 1 - and 4-year Kaplan-Meier survival of the antiarrhythmic drug-treated group was 91 + / - 6 % and 78 + / - 15 % , respectively , and of the surgical group 92 + / - 6 % and 59 + / - 20 % , respectively , and did not differ between either group .
RESULTS	However , the relative risk for total cardiac death was higher in the surgical limb than in the drug limb ( relative risk 2.2 , CI 0.68-7 .48 ) .
CONCLUSIONS	This study demonstrated no difference between the therapeutic result of continuation of two different antiarrhythmic drugs and that of arrhythmia surgery .
CONCLUSIONS	Despite the small number of patients studied , it is recommended that drug therapy should continue as long as this regimen is tolerated by the patient .
CONCLUSIONS	When true drug refractoriness or side-effects of drugs arise , arrhythmia surgery offers a valuable alternative .
CONCLUSIONS	However , when additional reasons for cardiac surgery exist , arrhythmia surgery should be undertaken earlier and may become the first choice of treatment of postinfarction ventricular tachycardia .

###9247511
OBJECTIVE	This study was conducted to test the hypothesis that angiotensin-converting enzyme ( ACE ) inhibition reduces myocardial ischemia and related events after myocardial infarction ( MI ) .
BACKGROUND	The oxygen demand/supply ratio of the myocardium is influenced by angiotensin II as a result of its arterial vasoconstrictive and inotropic effects and through its interaction with the sympathetic nervous system .
METHODS	We studied 244 patients who had been included in a double-blind , randomized , placebo-controlled , post-MI , ACE inhibition intervention study ( Captopril and Thrombolysis Study [ CATS ] ) .
METHODS	All patients underwent exercise testing before and 3 and 12 months after hospital discharge .
METHODS	After 1-year double-blind treatment , all patients continued receiving single-blind placebo for 1 month .
RESULTS	Total exercise time increased in both groups after 3 months ( placebo : +86 + / - 13 s ; captopril : +69 + / - 12 s , p = 0.8 between groups ) and increased further after 1 year ( placebo : +13 + / - 11 s ; captopril : +33 + / - 13 s , p = 0.7 between groups ) .
RESULTS	There were also no differences in mean ST segment depression .
RESULTS	During the 12 months , significantly fewer ischemia-related events occurred in the captopril group ( 82 vs. 52 , p = 0.015 ) .
RESULTS	This difference was found between 3 and 12 months but not during the first 3 months .
RESULTS	After withdrawal from double-blind medication , nine ischemic events were reported in teh captopril group compared with one in the placebo group ( p = 0.006 between groups ) .
CONCLUSIONS	The present data show that captopril may reduce the incidence of ischemia-related events after MI , which becomes apparent after 3 months .
CONCLUSIONS	However , no anti-ischemic effect was observed during exercise testing .
CONCLUSIONS	After withdrawal from ACE inhibition , a high incidence of clinical events occurred , suggesting a rebound phenomenon .

###21162825
OBJECTIVE	To determine the efficient cut-off points of fasting fingertip blood glucose test for undiagnosed diabetes mellitus ( DM ) , impaired glucose tolerance ( IGT ) , and impaired fasting glucose ( IFG ) in community-based residents aged above 45 years old .
METHODS	A cluster-randomized study was conducted from May 2008 to January 2009 .
METHODS	A total of 3250 subjects aged above 45 years in two communities of Baoding city received questionnaire investigation and tested for fingertip blood glucose .
METHODS	Those subjects whose capillary blood glucose level 5.1 mmol/L were subjected to 75 g oral glucose tolerance test .
METHODS	Undiagnosed diabetes mellitus and pre-diabetes were identified by fasting plasma glucose and OGTT .
METHODS	In this study , the cut-off points of fasting capillary blood glucose for detecting undiagnosed diabetes and pre-diabetes were evaluated , using receiver operator characteristic curve ( ROC ) .
RESULTS	Of 1351 subjects that having had oral glucose tolerance test , 230 cases were diagnosed as diabetes mellitus ( 7.3 % ) , 166 cases ( 5.2 % ) as IFG , and 204 ( 6.7 % ) as IGT under fasting capillary blood glucose as test variable and state variables according to the following criteria .
RESULTS	( 1 ) FPG7 .0 mmol/L or/and 2hPG11 .1 mmol/L ( 2 ) FPG < 5.6 mmol/L ( 3 ) FPG < 7.0 mmol/L and 7.8 mmol/L2hPG11 .1 mmol/L , areas under three ROC curves were 0.905 , 0.633 and 0.719 , respectively .
RESULTS	The cut-off values of screening for undiagnosed DM , IGT and IFG were 6.0 mmol/L , 5.7 mmol/L , and 5.7 mmol/L , respectively .
RESULTS	When cut-off value of screening for undiagnosed DM was 6.0 mmol/L , the maximal sensitivity was 78.0 % and specificity was 89.3 % .
RESULTS	But there were both lower sensitivity and specificity in screening for IFG and IGT according to the best predicting value ( 5.7 mmol/L ) from the ROC curves ( 50.3 % and 28.0 % vs. 60.8 % and 28.0 % ) .
CONCLUSIONS	Fasting capillary blood glucose with the lower cut-point of 6.0 mmol/L in screening for undiagnosed diabetes mellitus alone , was relatively reliable , whereas for both IFG and IGT the fasting fingertip blood glucose tests were fallible .
CONCLUSIONS	It was convenient and could be used in screening the DM at the community level .

###18929814
OBJECTIVE	In this study , we examined whether cyclosporine was effective when combined with everolimus in clinical heart transplantation ( HT ) .
METHODS	From August 2004 to July 2007 , 108 adult patients underwent primary HT .
METHODS	The main exclusion criteria were : donors > 60 years ; cold ischemia times > 6 hours ; recipients of multiorgan transplantation or a previous transplantation ; and panel-reactive antibodies > or = 25 % .
METHODS	The cyclosporine plus everolimus regimen ( group CE , n = 32 ) was suggested first ; upon refusal or if the recipient or donor was positive for hepatitis B surface antigen or PCR + hepatitis C infection , then patient was randomly assigned to success cyclosporine plus mycophenolate mofetil ( MMF ; group CM , n = 24 ) or tacrolimus plus MMF ( group TM , n = 25 ) .
METHODS	All patients underwent similar operative procedures and postoperative care with protocol endomyocardial biopsies .
RESULTS	No 30-day mortality was noted in any group .
RESULTS	The efficacy failure rates were 3 % , 25 % , and 16 % in groups CE , CM , and TM , respectively ( P = .04 between groups CE and CM ) .
RESULTS	The 1-year survivals were 96.7 % + / - 18.1 % , 89.7 % + / - 29.8 % , and 81.0 % + / - 35.5 % for groups CE , CM , and TM , respectively ( P = .04 between groups CE and TM ) .
RESULTS	The 3-year survival rates were 91.9 % + / - 28.3 % , 79.8 % + / - 46.0 % , and 81.0 % + / - 35.5 % in groups CE , CM , and TM , respectively .
CONCLUSIONS	The 3 immunosuppressive regimens offered good efficacy after HT .
CONCLUSIONS	The cyclosporine plus everolimus regimen showed a significantly better result with less efficacy failure ( compared with cyclosporine plus MMF : 3 % vs 25 % ) and better 1-year survival compared with tacrolimus plus MMF : 96.7 % vs 81.0 % .

###26376136
BACKGROUND	Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable .
BACKGROUND	We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin .
BACKGROUND	However , its relative safety and efficacy as compared with conventional phototherapy are unknown .
METHODS	We conducted a randomized , controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large , urban Nigerian maternity hospital .
METHODS	The primary end point was efficacy , which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy ; we prespecified a noninferiority margin of 10 % for the difference in efficacy rates between groups .
METHODS	The need for an exchange transfusion was a secondary end point .
METHODS	We also assessed safety , which was defined as the absence of the need to withdraw therapy because of hyperthermia , hypothermia , dehydration , or sunburn .
RESULTS	We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy .
RESULTS	Filtered sunlight was efficacious on 93 % of treatment days that could be evaluated , as compared with 90 % for conventional phototherapy , and had a higher mean level of irradiance ( 40 vs. 17 W per square centimeter per nanometer , P < 0.001 ) .
RESULTS	Temperatures higher than 38.0 C occurred in 5 % of the infants receiving filtered sunlight and in 1 % of those receiving conventional phototherapy ( P < 0.001 ) , but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion .
CONCLUSIONS	Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety .
CONCLUSIONS	( Funded by the Thrasher Research Fund , Salt Lake City , and the National Center for Advancing Translational Sciences of the National Institutes of Health ; Clinical Trials.gov number , NCT01434810 . )

###7915979
OBJECTIVE	Dopexamine hydrochloride is a novel synthetic adrenergic agonist that combines the renal effects of dopamine with the hemodynamic effects of dobutatmine .
OBJECTIVE	Our study is designed to compare the hemodynamic , diuretic , and natriuretic effects of dopexamine and dobutamine in patients with reduced cardiac index following heart surgery .
METHODS	Prospectively randomized , blinded study .
METHODS	Operating room and intensive care unit of a large , urban , academic medical center .
METHODS	Twenty-eight patients undergoing elective coronary artery bypass grafting ( CABG ) with preoperative ejection fraction of at least 40 percent gave informed consent .
METHODS	The study group consisted of the ten patients who had a cardiac index < or = 2.5 L/min/m2 ( while receiving no inotropic medication ) immediately after separation from cardiopulmonary bypass .
METHODS	Study patients were randomly given a starting dose of either 5 micrograms/kg/min of dobutamine ( n = 5 ) or 2 micrograms/kg/min of dopexamine ( n = 5 ) .
METHODS	During the initial 30 min following separation from bypass , dosages were titrated incrementally to maintain cardiac index > or = 3.0 / L/min/m2 .
METHODS	Further titrations of the drug were done only if cardiac index fell below 3.0 L/min/m2 or if sustained tachycardia occurred during the 24-h study period .
METHODS	Data were collected at 5 - and 10-min intervals for the first 30 min after separation from bypass , hourly for the next 8 h , then every 2 h for the remainder of the study period .
RESULTS	Both drugs increased cardiac index by more than 50 percent over baseline ( dobutamine 2.2 + / - 0.1 to 3.5 + / - 0.2 [ p < 0.05 ] ; dopexamine , 2.3 + / - 0.1 to 3.5 + / - 0.1 [ p < 0.05 ] L/min/m2 ) .
RESULTS	The mean dose required to maintain cardiac index > or = 3.0 L/min/m2 was 1.5 micrograms/kg/min for dopexamine and 3.5 micrograms/kg/min for dobutamine .
RESULTS	There were no significant differences in either urinary output or net sodium excretion in the dopexamine group compared with the dobutamine group , and tachycardia ( heart rate > 120 beats/min ) was more common in the dopexamine group .
CONCLUSIONS	Our study demonstrates that dopexamine produces hemodynamic , diuretic , and natriuretic effects similar to dobutamine in patients with reduced cardiac index following CABG .

###24563922
BACKGROUND	This randomised , double blind prospective study compares intrathecal lidocaine with chloroprocaine in day-case surgery and the influence of a 500 ml pre-load intravenously .
BACKGROUND	We tested the hypothesis that chloroprocaine provides faster recovery and discharge in day-case surgery .
BACKGROUND	Secondary we studied the influence of a preload compared with fluid restriction on discharge time and micturition problems .
METHODS	One hundred patients undergoing day-case arthroscopy were randomised to receive either lidocaine ( L ) 60 mg or chloroprocaine ( CP ) 40 mg intrathecally and this with ( L + , CP + ) or without ( L , CP ) a 500 ml pre-load of crystalloid .
METHODS	Block characteristics , micturition and discharge times were registered .
METHODS	Bladder volumes were monitored by ultrasound .
METHODS	Micturition problems received a micturition score .
RESULTS	Onset and quality of the block were comparable between groups .
RESULTS	Time to regain Bromage 1 and L2 regression were shorter for the CP group compared with the L group .
RESULTS	Voiding ( 168 44 min ) and discharge ( 178 52 min ) were approximately 40 min faster for the CP group compared with the L group .
RESULTS	Pre-load provided faster bladder filling but there were no differences in voiding time within the CP or L group .
RESULTS	The CP + group ( 166 36 min ) was discharged faster than both L groups ( 226 57 min , 227 59 min ) .
RESULTS	More serious micturition problems occurred in the L + group compared with both CP groups .
CONCLUSIONS	Chloroprocaine is suitable for day-case surgery because of faster block regression and discharge than lidocaine .
CONCLUSIONS	A 500 ml pre-load may not affect discharge but did not increase micturition problems for chloroprocaine .

###16835602
OBJECTIVE	To analyse the changes in thiamin intake and blood levels of young , overweight/obese women following slightly hypocaloric diets based on the increased relative consumption of foods whose intakes were most removed from the ideal : cereals and vegetables .
METHODS	The women were randomly assigned to one of two slightly hypocaloric diets : diet V , in which the consumption of vegetables was increased , or diet C , in which the consumption of cereals ( especially breakfast cereals ) was increased .
METHODS	The study subjects were 67 young women with a body mass index of 24-35 kg/m2 .
METHODS	Dietetic , anthropometrics and biochemical data were collected at the start of the study and again at 2 and 6 weeks .
RESULTS	The reduction in energy intake was similar in both groups .
RESULTS	However , diet C subjects lost significantly more weight .
RESULTS	Blood thiamin concentration was higher in group C women than in group V women at 2 and 6 weeks .
RESULTS	Compared to initial values , group C subjects showed a higher blood thiamin level at 2 weeks .
RESULTS	The highest blood thiamin levels seen in group C women may have been due to their greater thiamin intake , their higher thiamin dietetic density , and a higher thiamin/carbohydrates ratio at both week 2 and 6 of the intervention period .
CONCLUSIONS	Increasing the relative consumption of breakfast cereals within the context of a slightly hypocaloric diet can help in weight control and improve thiamine intake and blood levels .

###8214177
OBJECTIVE	Although many studies have documented patterns of emotional distress in persons with HIV disease , there have been few controlled evaluations of therapy outcomes with these individuals .
OBJECTIVE	This research evaluated the effects of brief cognitive-behavioral or social support group therapy with this population .
METHODS	Sixty-eight depressed men with HIV infection were randomly assigned to one of three conditions : eight-session cognitive-behavioral groups , eight-session social support groups , or a comparison condition .
METHODS	Before and after intervention and at 3-month follow-up , all participants were individually assessed by using measures of symptoms of distress as well as substance use and sexual practices .
RESULTS	Relative to the comparison group , both the cognitive-behavioral and social support group therapies produced reductions in depression , hostility , and somatization .
RESULTS	The social support intervention also produced reductions in overall psychiatric symptoms and tended to reduce maladaptive interpersonal sensitivity , anxiety , and frequency of unprotected receptive anal intercourse , while the cognitive-behavioral intervention resulted in less frequent illicit drug use during the follow-up period .
RESULTS	Tests for clinical significance of change particularly underscored benefits of the social support group intervention both at postintervention and at long-term follow-up .
CONCLUSIONS	Brief group therapy for depressed persons with HIV infection produced reductions in symptoms of distress .
CONCLUSIONS	The two forms of therapy resulted in shared and unique improvements in functioning , although social support groups focused on emotional coping presented greater evidence of clinically significant change .
CONCLUSIONS	As more persons contract HIV infection and live longer with HIV disease , further research is needed to evaluate outcomes of mental health services with these individuals .

###19481750
OBJECTIVE	To assess the prevalence of fecal incontinence ( FI ) during pregnancy and post partum , and to determine any associations with demographic and birth variables .
METHODS	Secondary analysis of 240 primiparous women conducted during pregnancy and post partum .
METHODS	Women were asked at various time points if they had lost control over their stool or bowel movements , and if they were practicing Kegel exercises .
METHODS	Associations of bowel symptoms with demographic and birth data were evaluated .
RESULTS	Most participants were white ( 87 % ) , with a median age of 30 years ( range , 18-42 years ) .
RESULTS	Women who reported fecal incontinence at 1 year were more educated than those who did not report it .
RESULTS	No other demographic or birth data were associated with fecal incontinence at 1 year .
CONCLUSIONS	Prevalence of FI during pregnancy and post partum is low and not linked to low-risk birth .
CONCLUSIONS	Furthermore , when FI occurs it is often sporadic .
CONCLUSIONS	This should be reassuring to patients and providers alike .

###19378676
OBJECTIVE	To assess the long-term safety and efficacy of the paclitaxel-eluting TAXUS moderate-release ( MR ) investigation-only stent for the treatment of long , complex coronary artery lesions .
RESULTS	TAXUS VI was a prospective , double-blind , multicentre trial wherein 446 patients were randomised between a TAXUS Express MR stent and an uncoated Express Control stent .
RESULTS	At 5-years , the overall rate of major adverse cardiac events ( MACE ) was similar in the two groups at 27.8 % in control and 31.3 % in TAXUS ( P = 0.61 ) , including similar rates for stent thrombosis .
RESULTS	The target vessel revascularisation ( TVR ) rate was 23.7 % in control and 22.2 % in TAXUS ( P = 0.45 ) with a non-target lesion revascularisation ( non-TLR ) rate of 5.1 % in control and 10.9 % in TAXUS ( P = 0.0274 ) and a TLR rate of 21.4 % in control and 14.6 % in TAXUS ( relative reduction , 32 % ; P = 0.0325 ) .
RESULTS	Furthermore , subgroup analysis revealed that the TLR benefit of TAXUS was preserved among study groups including small vessels , long lesions and patients receiving multiple overlapping stents .
CONCLUSIONS	Treatment of complex coronary lesions with the TAXUS MR stent demonstrated similar MACE , similar TVR , and reduced TLR rates compared with control through five years .
CONCLUSIONS	Based on these positive results , the aetiology of increased non-TLR TVR rate in TAXUS remains unclear .

###10408485
BACKGROUND	Platelet dysfunction is a major cause of excessive microvascular bleeding after cardiac surgery .
BACKGROUND	A new point-of-care test ( hemoSTATUS ) can identify patients at risk of excessive bleeding .
BACKGROUND	We aimed to find out whether patients who can benefit from desmopressin during cardiac surgery can be identified by this test .
METHODS	We enrolled 203 patients scheduled for elective cardiac surgery in a prospective , double-blind , placebo-controlled trial .
METHODS	Patients with abnormal hemoSTATUS clot-ratio results ( < 60 % of maximum in channel 5 ) after discontinuation of cardiopulmonary bypass were randomly assigned desmopressin ( n = 50 ) or placebo ( n = 51 ) .
METHODS	Patients with normal clot ratios were included in an untreated control group ( n = 72 ) .
RESULTS	Intraoperative platelet counts and clot ratios were significantly higher in the untreated control group than in the study-drug groups .
RESULTS	In intensive care , clot ratios in patients who received desmopressin were similar to those in the untreated control group , despite significantly lower platelet counts , but were lower in the placebo group than in the other two groups ( p = 0.0001 ) .
RESULTS	Compared with the placebo group , patients who received desmopressin had less blood loss in 24 h ( mean 624 [ SD 209 ] vs 1028 mL [ 682 ] p = 0.0004 ) and required less transfusion of red blood cells ( 1.1 [ 022 ] vs 2.2 U [ 0.32 ] p = 0.009 ) , platelets ( 0.1 [ 0.04 ] vs 1.9 U [ 4.5 ] p = 0.0001 ) , and fresh-frozen plasma ( 0.1 [ 0.07 ] vs 0.75 U [ 0.21 ] p = 0.0008 ) , and had less total blood-donor exposures ( 1.56 [ 0.31 ] vs 5.2 [ 0.8 ] p = 0.0001 ) .
RESULTS	Placebo patients also had substantially higher blood loss and transfusion requirements than untreated control patients .
CONCLUSIONS	Patients identified with hemoSTATUS as being at increased risk of excessive bleeding after cardiac surgery can benefit from administration of desmopressin .
CONCLUSIONS	Further studies are , however , needed to confirm these findings as well as to identify the mechanism of action and safety of desmopressin in the clinical setting .

###12771974
BACKGROUND	Hypercholesterolemia is an important risk factor for cardiovascular disease .
BACKGROUND	Orally administered chitosan binds lipids in the small intestine and reduces their absorption .
BACKGROUND	Chitosan has been shown to decrease serum cholesterol in animal and human studies .
BACKGROUND	This study investigated the effectiveness of chitosan in reducing serum cholesterol without concomitant diet therapy .
METHODS	Ninety female volunteers ( age 34-70 y ) with confirmed mild to moderate hypercholesterolemia were enrolled into the study .
METHODS	They were randomly assigned to receive chitosan ( 1.2 g per day ) or placebo in a double-blind manner .
METHODS	Serum lipids , body weight and adverse events were assessed at baseline and after 28 and 56 days of treatment .
METHODS	Subjects maintained their usual diet and documented the type and gross amount of food consumed .
RESULTS	Eighty-four subjects ( 41 chitosan , 43 placebo ) were included in the analysis .
RESULTS	Chitosan significantly ( F = 3.19 , P = 0.04 ) reduced total cholesterol compared to placebo .
RESULTS	In a subgroup of subjects with over 60 y of age , chitosan group significantly reduced total and LDL cholesterol ( F = 4.21 , P = 0.02 , and F = 3.46 , P = 0.04 , respectively ) compared with placebo .
RESULTS	Adverse effects were few ; no serious events were reported .
CONCLUSIONS	Our results demonstrate that chitosan is safe and effective for lowering cholesterol .
CONCLUSIONS	However , the effect of chitosan for decreasing cholesterol is mild .

###21666939
OBJECTIVE	To examine the effects of alpha-lipoic acid ( ALA ) treatment over a period of 2 months on fasting blood glucose ( FBG ) , insulin resistance ( IR ) , and glutathione peroxidase ( GH-Px ) activity in type 2 diabetes ( T2DM ) patients .
METHODS	This study took place in Motahari Clinic , Shiraz , Iran , which is affiliated to Shiraz University of Medical Sciences from May to October 2006 .
METHODS	Type 2 DM patients ( n = 57 ) were divided into 2 groups to receive either ALA ( 300 mg daily ) or placebo by systematic randomization , and were followed-up for 8 weeks .
METHODS	After an overnight fasting and 2 hours after breakfast , patients ' blood samples were drawn and tested for FBG , 2 hours PPG , serum insulin level , and GH-Px activity .
RESULTS	The result of the study showed a significant decrease in FBG and PPG levels , IR-Homeostasis Model Assessment ( IR-HOMA index ) and GH-Px level in the ALA group .
RESULTS	The comparison of differences between FBG and IR at the beginning and at the end of study in the ALA treated group and the placebo group were also significant .
CONCLUSIONS	This study supports the use of ALA as an antioxidant in the care of diabetic patients .

###14687309
OBJECTIVE	To compare a proprietary extract of American ginseng , CVT-E002 , with placebo in preventing acute respiratory illness ( ARI ) in an institutional setting during the influenza season .
METHODS	Two randomized , double-blind , placebo-controlled trials conducted late in the 2000 ( 8 week ) and 2000-2001 ( 12 week ) influenza seasons .
METHODS	Long-term care setting that included nursing home and assisted living at three sites .
METHODS	Eighty-nine ( 2000 ) and 109 ( 2000-2001 ) enrolled subjects , average age 81 and 83.5 , respectively ; 74 % women .
METHODS	Approximately 90 % had received influenza vaccine in each of the 2 years .
METHODS	Oral twice-daily administration of a proprietary ginseng extract , CVT-E002 , 200 mg or placebo .
METHODS	ARI was defined as two new respiratory symptoms or one with a constitutional symptom .
METHODS	Confirmation of viral ARI was by culture ( influenza or respiratory syncytial virus ( RSV ) ) or serology for influenza .
METHODS	Laboratory safety monitoring was done at 0 , 4 , and 8 or 12 weeks .
RESULTS	An intent-to-treat analysis of pooled data corrected for drug exposure time showed that the incidence of laboratory-confirmed influenza illness ( LCII ) was greater in placebo - ( 7 cases/101 subjects ) than CVT-E002-treated ( 1/97 ) groups ( odds ratio ( OR ) = 7.73 , P = .033 ) .
RESULTS	Combined data for LCII and RSV illness were also greater in placebo - ( 9/101 ) than CVT-E002-treated ( 1/97 ) groups ( OR = 10.50 , P = .009 ) , for an overall 89 % relative risk reduction of ARI in the CVT-E002 group .
CONCLUSIONS	CVT-E002 was shown to be safe , well tolerated , and potentially effective for preventing ARI due to influenza and RSV .

###16046372
OBJECTIVE	Irritable bowel syndrome ( IBS ) and panic disorder ( PD ) coexist with a high frequency .
OBJECTIVE	However , the nature of this relationship remains obscure .
OBJECTIVE	We have proposed that PD and IBS may share a common dysfunction of the central cholecystokinin ( CCK ) system .
OBJECTIVE	To test this hypothesis , we assessed whether the enhanced panicogenic response to CCK-tetrapeptide ( CCK-4 ) observed in PD is also present in IBS .
METHODS	Eight psychiatrically healthy IBS patients , 8 PD patients with no history of IBS , and 12 normal controls received a bolus injection of CCK-4 and placebo on two separate days in a double-blind , randomized fashion .
RESULTS	Consistent with previous findings , panicogenic sensitivity to CCK-4 was enhanced in PD patients relative to controls .
RESULTS	In contrast , IBS patients exhibited a response that was comparable to controls .
RESULTS	Interestingly , CCK-4-induced nausea and abdominal distress were decreased in IBS patients relative to the other groups .
RESULTS	No diagnostic difference was noted for cardiovascular response to CCK-4 .
CONCLUSIONS	These data indicate that IBS patients with no lifetime psychiatric history do not share the CCK-2 receptor dysfunction implicated in the pathophysiology of PD and that this dysfunction may not be a common mechanism for both CNS and enteric nervous system disorders .
CONCLUSIONS	Nevertheless , the results suggest that a dysfunction of the CCK system may be involved in the pathophysiology of some enteric symptoms associated with IBS .

###15506597
OBJECTIVE	To evaluate the incidence of ophthalmologic and systemic complications in patients who undergo cataract surgery without preoperative tests compared to subjects undergoing cataract surgery preceded by preoperative tests .
METHODS	The randomized controlled study included 1276 consecutive patients admitted to the Institute of Ophthalmology of the University of Modena and Reggio Emilia for cataract surgery .
METHODS	The patients were randomly divided into two groups : 638 were assigned not to undergo preoperative evaluation based on routine medical tests and electrocardiograms ; the other 638 underwent preoperative evaluation based on said tests .
METHODS	Ophthalmologic and systemic complications were assessed intraoperatively and 1 month after surgery .
RESULTS	Eleven intraoperative complications occurred in the group without preoperative tests and eight in the group with preoperative tests ; at 1 month six complications were recorded in the group without tests and five in the group with tests .
RESULTS	Systemic adverse events occurred intraoperatively in four patients , whereas no systemic adverse event was recorded at 1 month in either group .
RESULTS	No statistically significant differences were observed between the two groups .
CONCLUSIONS	The findings of this study have broad applicability , because the sample is representative of the population existing in numerous social and healthcare settings ; they are of value for administrative purposes , because they may be taken as reference in resource allocation plans ; and they have medicolegal implications , as the resulting conduct of healthcare providers is supported by a rigorous scientific study .

###12807615
OBJECTIVE	Mental health education for the staffs of nursing homes is difficult to provide and often inadequate .
OBJECTIVE	The objectives of this study were to design and assess a curriculum of staff training on depression and dementia that is accessible , educational , and relevant .
METHODS	A core curriculum of 12 computer-based interactive video training modules was created in a television news-documentary format to educate nursing home staffs .
METHODS	A randomized trial of the first six modules , which are dedicated to mental health and aging , was conducted at a computer site ( CS ) , a `` lecture site '' ( LS ) , and control site ( CON ) .
METHODS	Three not-for-profit nursing facilities in Western Pennsylvania .
METHODS	The certified nursing assistants , and other nursing staff participated in the study as part of their required training .
METHODS	Nursing staffs at the two intervention sites ( CS and LS ) were mandated to participate in monthly educational sessions .
METHODS	At the CS , the computer program scheduled staff members each month for 45 minutes of individual , self-paced training using the interactive video modules .
METHODS	At the LS , staff members were scheduled to attend a 45-minute monthly lecture with identical learning objectives delivered by an advanced degree nurse educator .
METHODS	A videotape of the lectures was shown at two additionally scheduled times during the month to accommodate all shifts .
METHODS	Compliance and satisfaction with training were monitored at both intervention sites .
METHODS	Knowledge was assessed at the CS , LS , and CON , before each monthly training session , and with a cumulative post-training exam , administered at the end of the 6-month study .
RESULTS	Over the 6-month period , training compliance was 66 % and 22 % at CS and LS , respectively ( P < 0.001 ) .
RESULTS	Satisfaction with training and the relevance of training were rated significantly higher at the CS ( P < 0.0001 ) .
RESULTS	Before the study , assessed knowledge was similar at the CS , LS , and CON .
RESULTS	After 6 months , the CS scored significantly higher than the LS and CON in terms of knowledge ( P < 0.005 ) .
CONCLUSIONS	Individual , self-paced , interactive video education for nursing home staff resulted in greater compliance and satisfaction with training compared to staff receiving lectures .
CONCLUSIONS	Knowledge of core concepts was greater for staff of the computer site compared to the staffs of either the lecture or control sites at the end of this 6-month study .

###25041486
BACKGROUND	Ilaprazole , a proton pump inhibitor ( PPI ) currently in clinical use , may provide improved acid suppression vs. other PPIs .
OBJECTIVE	To compare the pharmacodynamic and pharmacokinetic profiles of ilaprazole and esomeprazole .
METHODS	A phase 1 , randomised , open-label , single-centre , 4-period crossover study was conducted in 40 healthy volunteers .
METHODS	Ilaprazole 10 , 20 or 40mg or esomeprazole 40mg was administered once daily for 5days with 5-day washout intervals .
METHODS	Pharmacokinetic blood samples and intragastric pH measurements were collected at scheduled timepoints for 24h after dosing on Days 1 and 5 .
RESULTS	Esomeprazole 40mg provided significantly better pH control during the initial hours ( 0-4h ) after a single dose , but ilaprazole ( particularly 20 and 40mg ) provided significantly better pH control for the entire 24-h period and during evening and overnight hours after single and multiple doses .
RESULTS	Increasing ilaprazole doses resulted in dose-proportional increases in peak plasma concentration and area under the plasma concentration vs. time curve following single and multiple doses .
RESULTS	Ilaprazole was safe and generally well tolerated ; an unexpectedly high incidence of allergic eye and skin reactions were observed but were not specific to any dosing regimen .
RESULTS	Plasma gastrin concentrations did not increase proportionately with increasing ilaprazole dose .
CONCLUSIONS	Ilaprazole provided significantly better pH control over 24h and during evening and overnight hours compared with esomeprazole in healthy volunteers , which may translate to greater relief of night-time heartburn in the clinical setting for patients with gastric acid-related disorders .

###25131034
BACKGROUND	Candidates for liver transplantation may have malnutrition , fatigue , loss of muscle mass and function .
BACKGROUND	The combination of these factors leads to overall physical disability and physical inactivity .
OBJECTIVE	The aim of the study was to evaluate the effects of a respiratory physiotherapeutic program on liver transplantation candidates .
METHODS	Forty-two patients were evaluated by respiratory muscle strength , surface electromyography of the rectus abdominis and diaphragm , and spirometry .
METHODS	We also applied the SF-36 .
METHODS	The patients were divided into two groups : 12 randomly assigned to the control group and 5 in the intervention group .
METHODS	The intervention consisted of an explanatory and illustrative manual to be followed at home with diaphragmatic breathing exercises , diaphragmatic isometric exercise , Threshold IMT , lifting the upper limbs with a bat , and strengthening the abdominals .
RESULTS	Significant difference was found between initial forced expiratory flow ( FEF ) 25-75 % ( P = .042 ) and final FEF25-75 in the intervention group .
RESULTS	The control group had significant difference ( P = .036 ) in the diaphragm RMS between initial time and end time .
RESULTS	In conclusion , the control group showed greater electrical activity of the diaphragm after 3 months .
CONCLUSIONS	The intervention group benefited from the exercise , thus improving the FEF25-75 % .

###22679301
OBJECTIVE	To determine the most effective induction disease-modifying antirheumatic drug ( DMARD ) strategy in early rheumatoid arthritis ( RA ) , second to compare one single dose of intramuscular glucocorticoids ( GCs ) with daily oral GCs during the induction phase .
METHODS	The 3-month data of a single-blinded clinical trial in patients with recent-onset arthritis ( tREACH ) were used .
METHODS	Patients were included who had a high probability ( > 70 % ) of progressing to persistent arthritis , based on the prediction model of Visser .
METHODS	Patients were randomised into three induction therapy strategies : ( A ) combination therapy ( methotrexate ( MTX ) + sulfasalazine + hydroxychloroquine ) with GCs intramuscularly ; ( B ) combination therapy with an oral GC tapering scheme and ( C ) MTX with oral GCs similar to B.
METHODS	A total of 281 patients were randomly assigned to strategy ( A ) ( n = 91 ) , ( B ) ( n = 93 ) or ( C ) ( n = 97 ) .
RESULTS	The Disease Activity Score ( DAS ) after 3 months was lower in patients receiving initial combination therapy than in those receiving MTX monotherapy ( 0.39 ( 0.67 to 0.11 , 95 % CI ) ) .
RESULTS	DAS did not differ between the different GC bridging treatments .
RESULTS	After 3 months 50 % fewer biological agents were prescribed in the combination therapy groups .
RESULTS	Although the proportion of patients with medication adjustments differed significantly between the treatment arms , no differences were seen in these adjustments due to adverse events after stratification for drug .
CONCLUSIONS	Triple DMARD induction therapy is better than MTX monotherapy in early RA .
CONCLUSIONS	Furthermore , no differences were seen in medication adjustments due to adverse events after stratification for drug .
CONCLUSIONS	Intramuscular and oral GCs are equally effective as bridging treatments and both can be used .

###23704677
OBJECTIVE	To determine the prevalence of retinopathy in 517 youth with type 2 diabetes of 2-8 years duration enrolled in the TODAY study .
METHODS	Retinal photographs were graded centrally for retinopathy using established standards .
RESULTS	Retinopathy was identified in 13.7 % of subjects .
RESULTS	Prevalence increased with age , diabetes duration , and mean HbA1c .
RESULTS	Subjects in the highest BMI tertile had the lowest prevalence of retinopathy .
CONCLUSIONS	Prevalence of retinopathy and its association with HbA1c and diabetes duration is similar to that previously reported in youth with type 1 diabetes and in adults with type 2 diabetes of known duration .
CONCLUSIONS	The mechanism underlying the reduced risk of retinopathy in the most obese individuals is unknown .
CONCLUSIONS	Follow-up of this cohort will help define the natural history of retinopathy in youth with type 2 diabetes .

###16197668
OBJECTIVE	This prospective , randomized , open-label , multicenter , community-based study was conducted to compare cyclobenzaprine 5 mg three times daily ( TID ) orally ( CYC5 ) given for 7 days as monotherapy or in combination with ibuprofen 400 mg TID ( CYC5/IBU400 ) or 800 mg TID ( CYC5/IBU800 ) in adults with acute neck or back pain with muscle spasm .
METHODS	Eligible patients were 18-65 years old , had cervical or thoracolumbar pain and spasm for < or = 14 days , and , aside from the prescribed study medications , discontinued treatment with all analgesics , anti-inflammatory agents , and skeletal muscle relaxants during the study period .
METHODS	Randomization was 1:1:1 to the three treatment groups .
METHODS	Treatment outcome was assessed after 3 and 7 days of therapy using five patient-rated scales : spasm , pain , patient global impression of change ( PGIC ) , medication helpfulness , and Oswestry Disability Index ( ODI ) .
RESULTS	A total of 867 patients provided postbaseline data and were included in the intent-to-treat population ( CYC5 , n = 288 ; CYC5/IBU400 , n = 286 ; CYC5/IBU800 , n = 293 ) .
RESULTS	All three treatment groups demonstrated significant improvements from baseline in PGIC , spasm , pain , ODI , and medication helpfulness ( p < 0.001 for all comparisons ) after 3 and 7 days of therapy .
RESULTS	There were no significant differences in mean PGIC among groups after 3 days of therapy ( p = 0.65 for treatment effect ) or after 7 days of therapy ( primary endpoint ; p = 0.41 ) .
RESULTS	A PGIC responder analysis of changes from baseline showed that 88 % and 93 % of patients reported at least mild improvement after 3 and 7 days of therapy , respectively .
RESULTS	All three treatments were well tolerated , with no significant differences between treatments regarding the number of adverse events ( AEs ) reported or number of patients reporting AEs .
RESULTS	The most common AEs in all groups were fatigue , somnolence , dizziness , sedation , and nausea .
RESULTS	Limitations of this study include an unblinded design and possible introduction of bias into efficacy and safety results by use of a voluntary telephone reporting system .
CONCLUSIONS	This randomized , community-based clinical trial demonstrated that combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone in adult patients with acute neck and back pain with muscle spasm .
CONCLUSIONS	All treatments were well tolerated .

###7687093
OBJECTIVE	To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure .
METHODS	Ninety-seven patients with orthostatic hypotension were randomized in a 4-week , double-blinded , placebo-controlled study with a 1-week placebo run-in period .
METHODS	Patients ranged in age from 22 to 86 years ( mean : 61 years ) .
METHODS	After a 1-week run-in phase , either placebo or midodrine at a dose of 2.5 mg , 5 mg , or 10 mg was administered three times a day for 4 weeks .
METHODS	Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase .
METHODS	The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached .
METHODS	Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension ( syncope , dizziness/lightheadedness , weakness/fatigue , and low energy level ) .
RESULTS	Midodrine ( 10 mg ) increased standing systolic blood pressure by 22 mm Hg ( 28 % , p < 0.001 versus placebo ) .
RESULTS	Midodrine improved ( p < 0.05 ) the following symptoms of orthostatic hypotension compared to placebo : dizziness/lightheadedness , weakness/fatigue , syncope , low energy level , impaired ability to stand , and feelings of depression .
RESULTS	The overall side effects were mainly mild to moderate .
RESULTS	One or more side effects were reported by 22 % of the placebo group compared with 27 % of the midodrine-treated group .
RESULTS	Scalp pruritus/tingling , which was reported by 10 of 74 ( 13.5 % ) of the midodrine-treated patients , was most frequent .
RESULTS	Other reported side effects included supine hypertension ( 8 % ) and feelings of urinary urgency ( 4 % ) .
CONCLUSIONS	We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure .

###9785106
OBJECTIVE	To compare the efficacy and safety of a 7-day course of treatment with oral grepafloxacin , 400 mg once daily , and oral doxycycline , 100 mg twice daily , in patients with chlamydial cervicitis .
METHODS	Women aged 18 years or older attending 17 sexually transmitted disease clinics in the United States who had clinical signs of mucopurulent cervicitis or who had a recent positive culture or nonculture test for Chlamydia trachomatis or who had contact with a male partner with a positive culture for C. trachomatis were enrolled into this randomized , double-blind , active-controlled clinical study .
METHODS	The diagnosis of chlamydial cervicitis was based on culture for C. trachomatis .
METHODS	Patients were randomized to receive a 7-day course of treatment with either oral grepafloxacin , 400 mg once daily , or oral doxycycline , 100 mg twice daily .
METHODS	Response to therapy was assessed 3-8 days and 21-28 days after completion of treatment .
METHODS	The primary measure of efficacy was eradication of C. trachomatis at the 21-28 day follow-up visit .
METHODS	Clinical success , defined as improvement or complete resolution of the signs and symptoms of cervicitis , was a secondary measure of efficacy .
RESULTS	Of the 451 female patients enrolled , 228 received grepafloxacin and 223 received doxycycline .
RESULTS	In all , 154/451 ( 35 % ) patients were evaluable at the 21-28 day follow-up ( 81 who received grepafloxacin and 73 who received doxycycline ) .
RESULTS	Microbiologic and clinical success rates demonstrated the equivalence of the two treatments .
RESULTS	The C. trachomatis eradication rates were 96.3 % ( 78/81 ) and 98.6 % ( 72/73 ) for patients receiving grepafloxacin or doxycycline , respectively .
RESULTS	The two study drugs were also equivalent in resolving clinical signs and symptoms , with clinical success rates of 88.9 % ( 64/72 ) and 89.5 % ( 51/57 ) for patients treated with grepafloxacin and doxycycline , respectively .
RESULTS	Both drugs were well tolerated , with 47 % of patients receiving grepafloxacin and 46 % of patients receiving doxycycline experiencing drug-related adverse events , none of which was serious .
CONCLUSIONS	Seven days of treatment with oral grepafloxacin , 400 mg once daily , was as effective as 7 days of treatment with oral doxycycline , 100 mg twice daily , in patients with cervicitis caused by C. trachomatis .
CONCLUSIONS	Both agents were well tolerated and had comparable safety profiles .
CONCLUSIONS	Grepafloxacin 's once-daily dosing regimen may offer advantages in terms of patient compliance .

###17341752
BACKGROUND	The validity of parental reporting of children 's health outcomes is an important methodological issue in community-based pediatric research .
BACKGROUND	We assessed the validity of parents ' reports of their children 's acute otitis media ( AOM ) history over the previous month in a pilot study of xylitol for AOM prevention .
METHODS	Parents of children participating in a study conducted in the Slone Center Office-Based Research ( SCOR ) Network were interviewed monthly for 3 months and asked whether their child had been diagnosed with AOM in the previous month .
METHODS	A blinded physician reviewed medical records .
METHODS	Results from parental interviews and medical records were compared by correlation analysis .
RESULTS	Medical records were obtained for 102 of 120 children ( 85.0 % ) ; 272 monthly interviews were completed .
RESULTS	Kappa for the agreement between parental reports and medical records was 0.88 [ 95 % confidence intervals ( CI ) : 0.76 to 0.94 ] .
RESULTS	The positive predictive value of a parental report of an AOM episode within the previous month was 85.0 % , and the negative predictive value was 99.1 % .
CONCLUSIONS	The results of this study suggest that parental reporting of children 's recent AOM history correlates well with medical records .
CONCLUSIONS	Parental interview is a reasonable approach to collecting data on recent AOM outcomes , particularly in large-scale community-based studies where obtaining medical records is often impractical .

###15605000
BACKGROUND	Although the initial rate of hemostasis achieved by endoscopic epinephrine injection for peptic ulcer bleeding is high , bleeding recurs in 14.6 % to 35.5 % of patients .
BACKGROUND	The aim of this study was to compare rates of recurrent bleeding after endoscopic injection of two different volumes of epinephrine in patients with peptic ulcer bleeding .
METHODS	A total of 72 patients with peptic ulcer with active bleeding or a non-bleeding visible vessel were randomly assigned to 15 to 25 mL or 35 to 45 mL injections of a 1:10,000 solution of epinephrine .
RESULTS	The two groups were similar with respect to all background variables .
RESULTS	The mean volume of epinephrine injected was 19.4 mL : 95 % CI [ 18.7 , 20.1 ] in the 15 to 25 mL group and 41.1 mL : 95 % CI [ 40.0 , 42.2 ] in the 35 to 45 mL group .
RESULTS	Initial hemostasis was achieved in 35 of 36 patients ( 97.2 % ) in the 15 to 25 mL group and in all 36 patients in the 35 to 45 mL group .
RESULTS	The 35 to 45 mL volume was significantly more effective in preventing recurrent bleeding than the 15 to 25 mL volume ( 0 % vs. 17.1 % ; p < 0.05 ) .
RESULTS	For ulcers in the gastric body , the 35 to 45 mL volume was significantly more effective in preventing recurrent bleeding than the 15 to 25 mL volume ( 0 % vs. 31.6 % ; p = 0.003 ) .
RESULTS	For ulcers in other locations , including the gastric antrum and the duodenum , there were no significant differences in the rate of recurrent bleeding between the two groups .
CONCLUSIONS	Injection of 35 to 45 mL of a 1:10,000 solution of epinephrine is more effective than injection of 15 to 25 mL of the same solution for prevention of recurrent bleeding from ulcers in the body of the stomach .

###12209034
OBJECTIVE	To compare the efficacy of the COX-2 specific inhibitor valdecoxib with the conventional NSAID naproxen and placebo in treating rheumatoid arthritis ( RA ) .
METHODS	This multi-centre , randomized , double-blind , placebo-controlled trial compared the efficacy and safety of valdecoxib 10 mg ( n = 209 ) , 20 mg ( n = 212 ) or 40 mg once daily ( q.d. ) ( n = 221 ) with naproxen 500 mg b.i.d. ( n = 226 ) or placebo ( n = 222 ) , in treating the signs and symptoms of RA .
METHODS	Efficacy was assessed by the number of patients responding to treatment according to the American College of Rheumatology-Responder Index ( ACR-20 ) .
RESULTS	ACR-20 response was recorded for all randomized patients who received a single dose of study medication ( above ) .
RESULTS	Valdecoxib , at all administered doses , produced significant improvements in the ACR-20 Responder Index at weeks 2 , 6 and 12 compared with placebo ( P < or = 0.01 ) .
RESULTS	Valdecoxib and naproxen did not differ in terms of ACR-20 response rate and the three doses of valdecoxib were similar to one another .
RESULTS	All three doses of valdecoxib were well tolerated .
CONCLUSIONS	Single daily doses of valdecoxib 10 , 20 and 40 mg demonstrated efficacy that was superior to placebo and similar to naproxen in treating the signs and symptoms of RA .
CONCLUSIONS	All three doses provided similar levels of efficacy .

###24373281
OBJECTIVE	postoperative pain increases the activity of the sympathetic system , causes hypermetabolic conditions , retains salt and water , increases glucose , fatty acid lactate and oxygen consumption , weakens the immunity system which delays wound healing .
OBJECTIVE	Our object was comparison of the analgesic effect of morphine and paracetamol in the patients undergoing laparotomy , using PCA method .
METHODS	Seventy patients who had undergone laparotomy were studied using double blind randomized clinical trial ( 35 patients received morphine and 35 paracetamol ) in the Shahid Rajaee Center and Velayat Hospital ( Qazvin , Iran ) .
METHODS	People using opioids , painkillers and sedatives regularly and in large doses and patients with a history of lung or liver problems did not participate in this project .
METHODS	The parameters of the severity of pain and nausea ( VAS ) , hemodynamic changes ( BP and HR ) , pruritus , arterial oxygen desaturation and patient satisfaction ( VAS ) of both groups were measured by a third party ( trained colleague ) .
METHODS	The data was analyzed using SPSS 16 statistical software then descriptive results were extracted and ultimately the groups were compared using the following statistical tests : student 's T-test , chi 2 and Fisher 's exact test ( P < 0.05 ) .
RESULTS	The mean age of the participants was 4512.5 years .
RESULTS	Women constituted 24.3 % of the patients and men 75.7 % .
RESULTS	The average pain severity for morphine and paracetamol groups ( VAS ) was 5.32.2 and 6.371.7 after2 hours and reached 1.911.3 and 2.491.3 after 8 hours ( after the operation ) respectively .
RESULTS	There was a significant difference between the groups after 2 and 4 hours in terms of pain severity ( after 2 hours P = 0.007 and after 4 hours P = 0.047 ) .
RESULTS	However there was no significant difference between the average pain severity of the studied groups ( after 6 hours P = 0.4 and 8 hours P = 0.08 ) .
RESULTS	After 8 hours , the average nausea severity was the minimum in both groups being 1.711.6 and 1.431.1 in morphine and paracetamol groups respectively .
RESULTS	Nausea severity was higher after 2 hours in paracetamol group .
RESULTS	In morphine group , it was higher after 4 , 6 and 8 hours .
RESULTS	Difference between the groups was not significant .
RESULTS	The average satisfaction level ( VAS ) for morphine and paracetamol groups reached from 5.292.3 and 4.22.4 after 2 hours , to 7.941.8 and 7.692.1 after 8 hours ( after the operation ) , respectively .
RESULTS	The average satisfaction level of patients was higher in morphine group in 2,4,6 and 8 hours and except for , after 4 hours ( P = 0.01 ) , the satisfaction difference between both groups was not significant in other hours ( P = 0.06 after 2 hours , P = 0.6 after 6 hours and P = 0.5 after 8 hours )
CONCLUSIONS	Morphine seems to be more effective at 2 and 4 hours , but after 4 hours they have similar effects , the satisfaction difference between both groups was not significant in the patients .

###10778658
OBJECTIVE	To assess the bioquivalence of carbamazepine ( CBZ ) controlled release formulation A ( Tegretol CR , local ) vs formulation B ( Tegretol CR , Basel ) and confirm their controlled release characteristics by comparing with conventional formulation ( Tegretol ) .
METHODS	A three-way randomized cross-over bioavailability study was carried out using CBZ 200 mg tablets of conventional and two controlled release formulations in twelve healthy volunteers .
METHODS	Coded plasma samples were analysed for levels of CBZ by HPLC method .
RESULTS	The mean Cmax , Tmax , t1/2 and AUC for formulation A were : 1.67 + / - 0.26 mcg/mL , 24 + / - 0 hr , 47.8 + / - 9.7 hr and 136.7 + / - 25.4 mcg/ml .
RESULTS	h ; for formulation B were 1.41 + / - 0.31 mcg/mL , 25 + / - 8 hr , 46.9 + / - 7.9 and 119 + / - 32.3 mcg/ml .
RESULTS	h and for conventional formulation were 2.43 + / - 3.6 mcg/mL , 9.5 + / - 7.4 hr , 44.6 + / - 9.8 hr and 178.8 + / - 41.9 mcg/ml .
RESULTS	h respectively .
RESULTS	The fluctuation in plasma concentration within 24 h ( peak : trough ) were 11.7 + / - 8.14 % with conventional formulation as compared to 0 % and 1.2 + / - 3.98 % with formulation A and B respectively .
RESULTS	The mean Tmax for both the controlled release formulations was not statistically significant .
RESULTS	On the basis of 90 % confidence interval , mean AUC and Cmax values obtained after controlled release formulation A , though statistically significant ( P < 0.05 ) lie well within the prescribed limits of 80-120 % as compared to formulation B. Thus both the controlled release formulations were bioequivalent .
RESULTS	In comparison to conventional formulation , both controlled release formulations gave lower Cmax , lower AUCs , higher Tmax values , less fluctuation in CBZ plasma concentrations , reduction in ratio of Cmax/AUC values , thus demonstrating controlled release characteristics of the formulation .
CONCLUSIONS	Based on the above mentioned parameters both controlled release formulations are bioequivalent and demonstrate controlled release characteristics .

###17178181
BACKGROUND	Delayed beneficial effects of gabapentin on mood were frequently reported in various patient populations .
BACKGROUND	This is the first controlled study which addressed acute effects of gabapentin on mood .
METHODS	Analysis of the German version of Profile of Mood States ( POMS ) throughout a randomised placebo-controlled , double-blinded study of gabapentin on acute alcohol withdrawal [ Bonnet , U. , Banger , M. , Leweke , F.M. , Specka , M. , Mller , B.W. , Hashemi , T. , Nyhuis , P.W. , Kutscher , S. , Burtscheidt , W. , Gastpar , M. 2003 .
METHODS	Treatment of acute alcohol withdrawal with gabapentin -- results from a controlled two-center trial .
METHODS	J Clin Psychopharmacol 23 , 514-519 ] .
METHODS	In addition , subjective severity of alcohol withdrawal was determined by the Essen Self-Assessment of Alcohol Withdrawal Scale ( ESA ) to control effects of concurrent withdrawal on POMS .
METHODS	Ratings were performed at intake ( baseline ) , day 1 ( study medication 400 mg q.i.d. ) , day 2 ( study medication 400 mg q.i.d. ) and day 7 ( no study medication ) .
RESULTS	Analyses could be performed on 46 out of 59 randomised subjects .
RESULTS	Within the first two days of the study , a significant stronger increase in the POMS-vigour subscore occurred in the gabapentin group .
RESULTS	A subgroup analysis suggests that gabapentin 's effect on vigour largely results from a stronger improvement of vigour in a small group of 11 patients with co-morbid mild depression ( according to ICD-10 : dysthymia or depressive adjustment disorder ) .
RESULTS	There were no significant differences between the treatment groups regarding the other POMS-subscores ( dejection , fatigue , anger ) ruling out an overall fast effect on mood .
RESULTS	Moreover , ESA-measures were not significantly altered indicating a missing effect of 400 mg gabapentin q.i.d. on acute alcohol withdrawal itself .
RESULTS	After tapering off study medication , no more significant differences between gabapentin and placebo group were observed on vigour , strongly suggesting that the initial effect results from a pharmacological gabapentin action .
CONCLUSIONS	Gabapentin selectively accelerated the improvement of the vigour-subscore of patients with acute alcohol withdrawal within 48 h.
CONCLUSIONS	This effect was independent from the subjective severity of withdrawal and especially marked in patients with co-morbid mild depression .

###22310190
BACKGROUND	Fiberoptic intubation is a core skill in anesthesiology .
BACKGROUND	However , this complex psychomotor skill is challenging to learn in the clinical setting .
BACKGROUND	The goal of this study was to evaluate the Virtual Fiberoptic Intubation ( VFI ) software as an adjunct to the traditional fibreoptic intubation teaching .
METHODS	After informed consent , 23 first year anesthesia residents with no previous experience of fiberoptic intubation were randomized to 2 groups .
METHODS	All subjects received an institutional didactic teaching session .
METHODS	The control group ( N. = 12 ) was taught by the usual didactic method only , while the VFI group ( N. = 11 ) had the same didactic teaching and also the opportunity to practice with VFI software for one week .
METHODS	Each resident was evaluated on their first oro - and nasotracheal fiberoptic intubations on a mannequin head .
METHODS	Each performance was evaluated by an expert bronchoscopist blinded to the previous type of teaching using a checklist score , a global rating scale ( GRS ) score and procedural time .
RESULTS	The VFI group performed significantly better on the checklist and GRS scores compared to the control group for both the oral and nasal routes ( all P < 0.05 ) .
RESULTS	For procedural time , there was a trend towards faster performance in the VFI group compared to the control group for the oral route ( P = 0.05 ) .
RESULTS	There was no significant difference for procedural time between the VFI and the control groups when fiberoptic intubation was performed nasally ( P = 0.76 ) .
CONCLUSIONS	Self-directed practice using VFI software may improve the initial acquisition of fibreoptic intubation skills for anesthesia residents .

###22456770
OBJECTIVE	Common opioids for analgesia and sedation of mechanically ventilated infants may tend to accumulate and cause prolonged sedation with an unpredictable extubation time .
OBJECTIVE	Remifentanil is a promising option due to its unique pharmacokinetic properties , which seem to be valid in adults as well as in infants .
METHODS	In this double-blind , randomized , controlled trial mechanically ventilated neonates and young infants ( < 60 days ) received either a remifentanil or fentanyl-based analgesia and sedation regimen with low dose midazolam .
METHODS	The primary endpoint of the trial was the extubation time following discontinuation of the opioid infusion .
METHODS	Secondary endpoints included efficacy and safety aspects .
RESULTS	Between November 2006 and March 2010 , we screened 431 mechanically ventilated infants for eligibility .
RESULTS	The intention to treat group included 23 infants who were assigned to receive either remifentanil ( n = 11 ) or fentanyl ( n = 12 ) .
RESULTS	Although this was designed as a pilot study , median extubation time was significantly shorter in the remifentanil group ( 80.0 min , IQR = 15.0-165 .0 ) compared to the fentanyl group ( 782.5 min , IQR = 250.8-1 ,875.0 ) ( p = 0.005 ) .
RESULTS	Remifentanil and fentanyl provided comparable efficacy with more than two-thirds of the measurements indicating optimal analgesia and sedation ( 66.4 and 70.2 % , respectively ; p = 0.743 ) .
RESULTS	Overall , both groups had good hemodynamic stability and a comparably low incidence of adverse events .
CONCLUSIONS	As neonates and young infants have a decreased metabolism of common opioids like fentanyl and are more prone to respiratory depression , remifentanil could be the ideal opioid for analgesia and sedation of mechanically ventilated infants .

###9314631
OBJECTIVE	Insulin lispro is a rapid-acting analog of human insulin that can be used to target the postprandial rise in plasma glucose .
OBJECTIVE	We designed an open-label randomized crossover study of type 2 diabetic patients with secondary failure of sulfonylurea therapy to determine whether improvement of postprandial hyperglycemia would affect total daily glucose control .
METHODS	Twenty-five type 2 diabetic patients who were poorly controlled on a maximum dose of sulfonylureas were studied in a university hospital clinical research center .
METHODS	In one arm of the study , patients continued therapy with maximum-dose sulfonylureas .
METHODS	In the other arm , patients used a combination therapy with insulin lispro before meals and sulfonylureas .
METHODS	After 4 months , patients were crossed over to the opposite arm .
METHODS	Fasting plasma glucose ( FPG ) and 1 - and 2-h postprandial glucose ( after a standardized meal ) , HbA1c , total , HDL , and LDL cholesterol , and triglyceride levels were measured at the end of each arm of the study .
RESULTS	Insulin lispro in combination with sulfonylurea therapy significantly reduced 2-h postprandial glucose concentrations compared with sulfonylureas alone , from 18.6 to 14.2 mmol/l ( P < 0.0001 ) , and incremental postprandial glucose area from 617.8 to 472.9 mmol.min.1-1 ( P < 0.0007 ) .
RESULTS	FPG levels were decreased from 10.9 to 8.5 mmol/l ( P < 0.0001 ) , and HbA1c values were reduced form 9.0 to 7.1 % ( P < 0.0001 ) .
RESULTS	Total cholesterol was significantly decreased in the lispro arm from 5.44 to 5.10 mmol/l ( P < 0.02 ) .
RESULTS	HDL cholesterol concentrations were increased in the lispro arm from 0.88 to 0.96 mmol/l ( P < 0.01 ) .
RESULTS	The patients weighed significantly more after lispro therapy than after sulfonylureas alone , but the difference was small in absolute terms ( sulfonylurea therapy alone , 90.6 kg ; lispro therapy , 93.8 kg ; P < 0.0001 ) .
RESULTS	Two episodes of hypoglycemia ( glucose concentrations , < 2.8 mmol/l ) were reported by the patients while using lispro .
CONCLUSIONS	Previously , it has not been possible to address the effect of treatment of postprandial hyperglycemia specifically .
CONCLUSIONS	We have now shown that the treatment of postprandial hyperglycemia with insulin lispro markedly improves overall glucose control and some lipid parameters in patients with type 2 diabetes .

###12000375
BACKGROUND	Investigations of pruritogenic substances in humans have involved intradermal injections in normal skin ; itching of inflamed skin has been little studied .
OBJECTIVE	To develop an itch model with provocation of itch in experimentally inflamed skin as well as in normal skin , using subjects as self-controls .
METHODS	In 32 non-atopic volunteers aged 21-30 years , the skin of five selected test sites on one volar forearm was pretreated for 24 h with large Finn chambers containing 1 % sodium lauryl sulphate ( SLS ) used as a standard contact irritant to induce inflammation .
METHODS	Twenty microlitres of different pruritogenic substances [ histamine , substance P , neurokinin A , neurokinin B , trypsin , platelet-activating factor ( PAF ) and serotonin ] and saline as control were injected intradermally into the inflamed test sites and in corresponding non-treated sites on the opposite forearm .
METHODS	The test individuals scored itch intensity on a visual analogue scale for 20 min , and weal area was then measured .
RESULTS	Histamine and substance P induced itch in both normal and inflamed skin compared with a saline reference .
RESULTS	Neurokinin A , trypsin , PAF and serotonin only elicited itch in normal skin , and neurokinin B neither elicited itch in normal skin nor in inflamed skin .
RESULTS	Itch was induced in normal and SLS-inflamed skin to a similar magnitude .
RESULTS	However , weal area after histamine was significantly ( P < 0.001 ) larger in inflamed skin when compared with normal skin .
CONCLUSIONS	Histamine and substance P elicited itch to the same degree in normal skin and inflamed skin pretreated with SLS despite a stronger weal response in inflamed skin .
CONCLUSIONS	Mediators present in inflamed skin did not potentiate itch , a c-fibre-mediated neuronal response .
CONCLUSIONS	The weal reaction is based on enhanced vascular permeability ( protein extravasation ) .
CONCLUSIONS	A greater skin perfusion in inflamed skin may therefore have increased the weal size .
CONCLUSIONS	We propose an experimental model in humans for testing of itch involving both normal and inflamed skin .
CONCLUSIONS	The model has the potential for use in evaluating new topical and systemic treatments of itch .

###23672055
OBJECTIVE	To observe the effect of Zaoren Anshen capsules in treating senile insomnia and changes in its hemorheology .
METHODS	A total of 120 patients with senile insomnia were randomly divided into the Zaoren Anshen capsules group ( five capsules , n = 60 ) and the Alprazolam group ( 0.8 mg , n = 60 ) for treatment and control observation .
METHODS	Pittsburgh sleep quality index ( PSQI ) was used for evaluating clinical efficacy in the first and fourth week before and after treatment .
RESULTS	The Zaoren Anshen capsules group had lower higher scores in PSQI ( 5.91 + / - 1.37 ) than that before treatment ( 13.49 + / - 3.87 ) , with great statistical significant in difference ( P < 0.01 ) .
RESULTS	The alprazolam group had lower higher scores in PSQI than that before treatment , with great statistical significant in difference ( P < 0.01 ) .
RESULTS	apart from higher PSQI scores in the Zaoren Anshen capsules group than that of the Alprazolam group after treatment for one week ( P < 0.05 ) , the comparison between the Zaoren Anshen capsules group and the alprazolam group before and after treatment for four weeks showed no statistical significance .
RESULTS	As for hemorheological parameters , the difference in the whole blood viscosity ( including high-shear , middle-shear and low-shear ) of patients in the Zaoren Anshen capsules showed great statistical significance before and after treatment ( P < 0.01 ) , and so did the plasma viscosity ( P < 0.05 ) .
RESULTS	Zaoren Anshen capsules showed less adverse reactions than alprazolam .
CONCLUSIONS	Zaoren Anshen capsules have similar effect in treating senile insomnia with alprazolam , with less adverse reactions .
CONCLUSIONS	They are so suitable for patients with senile insomnia that they can improve hemorheological indicators of patients with senile insomnia and have good effect in promoting circulation and removing stasis .

###18609155
OBJECTIVE	The mechanisms underlying symptom improvement in gastric electrical stimulation ( GES ) are not fully understood .
OBJECTIVE	Modulation of the central nervous system excitability may be involved .
OBJECTIVE	The objective of the study was to investigate the central effects of GES , including the possible modulation of the visceral sensory nervous system .
METHODS	A gastric electrical stimulator was implanted in seven diabetic patients with medically refractory gastroparesis .
METHODS	A double-blinded protocol was used to investigate the patients at baseline and one month after recovery with the stimulator turned on and off ( 1-month periods ) .
METHODS	The following assessments were carried out : mechanical , thermal and electrical stimulations with sensory recordings in the esophagus and duodenum , and standardized , self-administered , daily symptom questionnaires .
RESULTS	No difference was found between baseline and the on - and off periods in overall gut pain thresholds across all stimulus modalities in the esophagus ( p = 0.63 ) , duodenum ( p = 0.19 ) or esophagus and duodenum combined ( p = 0.76 ) .
RESULTS	No difference in the sensory response to mechanical stimulation was found in the esophagus before ( all p > 0.31 ) and after ( all p > 0.43 ) smooth muscle relaxation with butylscopolamine .
RESULTS	Similar findings were observed in the duodenum .
RESULTS	No differences were found in thermal sensitivity ( esophagus ( p = 0.67 ) and duodenum ( p = 0.17 ) ) , sensory response to electrical stimulation ( esophagus ( p = 0.57 ) and duodenum ( p = 0.52 ) ) or induced somatic referred pain areas ( esophagus ( p = 0.75 ) and duodenum ( p = 0.51 ) ) .
RESULTS	No difference was seen in the induced somatic referred pain areas or self-reported symptoms .
CONCLUSIONS	No evidence was found for GES-induced modulation of the visceral sensory system and central excitability .
CONCLUSIONS	However , GES has been proven to modulate the central nervous system in animal studies , necessitating further human experiments in order unambiguously to establish the possible central effects of GES .

###11180022
OBJECTIVE	The purpose of this study was the development of pharmacokinetic and pharmacodynamic models for the luteinizing hormone ( LH ) suppression and subsequent shift in LH surge and follicle-stimulating hormone by cetrorelix in women .
BACKGROUND	Cetrorelix is a potent luteinizing hormone-releasing hormone ( LH-RH ) antagonist and is used for the prevention of the premature ovulation indicated by an LH surge in in vitro fertilization .
BACKGROUND	The pharmacokinetic and pharmacodynamic relationship for the suppression and the shift in the LH surge has not yet been established .
METHODS	In a placebo-controlled study , single subcutaneous doses of 1 , 3 , and 5 mg of cetrorelix were given to 36 subjects on day 8 of the natural menstrual cycle .
METHODS	Cetrorelix , LH , follicle-stimulating hormone , estradiol , and progesterone were determined .
RESULTS	Cetrorelix pharmacokinetics were described by a 2-compartment model with a terminal half-life of 56.9 + / - 27.1 hours .
RESULTS	Mean shift in LH surge was by 4.1 , 7.5 , and 9.3 days with the 1 - , 3 - , and 5-mg doses , respectively .
RESULTS	An indirect response sigmoid Emax model was developed for the suppression of LH and the shift in the LH surge .
RESULTS	The inhibitory concentration of 50 % ( for LH suppression ) and median effective concentration ( for surge shift ) estimates were 3.6 ng/mL and 1.6 ng/mL , respectively .
RESULTS	The suppression of follicle-stimulating hormone was described by a similar Emax model , with an inhibitory concentration of 50 % of 7.25 ng/mL .
CONCLUSIONS	A pharmacokinetic and pharmacodynamic model was developed for the transient initial suppression of LH and the subsequent shift in the LH surge after 3 single subcutaneous doses of cetrorelix without ovarian stimulation .
CONCLUSIONS	A separate model was developed for the suppression of follicle-stimulating hormone by cetrorelix .
CONCLUSIONS	The shift in the LH surge could be adequately described by the model .

###21733166
BACKGROUND	Urinary incontinence is an important health problem to the individual sufferer and to health services .
BACKGROUND	Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques .
BACKGROUND	Despite the lack of evidence for its clinical utility , most clinicians undertake invasive urodynamic testing ( IUT ) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition .
BACKGROUND	IUT is expensive , embarrassing and uncomfortable for women and carries a small risk .
BACKGROUND	Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness .
METHODS	This is a mixed methods pragmatic multicentre feasibility pilot study with four components : - ( a ) A multicentre , external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT .
METHODS	The outcome measures are rates of recruitment , randomisation and data completion .
METHODS	Data will be used to estimate sample size necessary for the definitive trial .
METHODS	( b ) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate , be randomised and their overall trial experience .
METHODS	( c ) A national survey of clinicians to determine their views of IUT in this context , the main outcome being their willingness to randomise patients into the definitive trial .
METHODS	( d ) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions .
CONCLUSIONS	The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial .
CONCLUSIONS	Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim .
BACKGROUND	Current Controlled Trials ISRCTN71327395 assigned 7th June 2010 .

###16162465
OBJECTIVE	To investigate the effects of two differently styled self-care health books in general practice on the frequency and duration of patients ' consultations and their views of the books .
METHODS	Random allocation of patients to either a descriptive or a decision-tree based self-care health book , or a no-book control condition .
METHODS	Three - and 12-months follow-up by postal questionnaire and monitoring of consultations .
METHODS	A large general practice in the South East of England .
METHODS	A total of 1967 volunteer , adult patients who attended the practice in 2001 participated .
METHODS	Demographics ; health problems ; use of health services ; use and perceptions of the trial book ; frequency and duration of consultations .
RESULTS	Response rates to postal questionnaires at 3 and 12 months were 80 % and 74 % .
RESULTS	In all , 48 % consulted their allocated book , compared with 25 % who consulted any healthcare book in the Control group .
RESULTS	Those reporting health problems were more likely to have consulted their allocated book ; 60 % reported that the allocated book made them more likely to deal with a problem themselves and 40 % reported themselves less likely to consult the practice .
RESULTS	However , there were no differences in consultation rates or durations of consultations between the three groups .
CONCLUSIONS	Handing out of self-care health books may provide qualitative benefits for patients but is unlikely to reduce attendance at the GP practice .

###21258306
BACKGROUND	To compare the efficiency of isotonic and hypertonic seawater solutions used for nasal lavage and quality of life of the patients with chronic rhinosinusitis .
METHODS	A random and controlled clinical study was performed .
METHODS	The study included 60 patients with history of chronic rhinosinusitis .
METHODS	At the beginning of the study , each subject was given a Patient Logbook , which needed to be filled out daily during the 15-day study period .
METHODS	There were three visits per each patient during the study .
RESULTS	Results Patient Logbook notes showed significant statistical differences in all symptoms in the group of patients using hypertonic seawater solution .
RESULTS	However , while the notes showed significant statistical differences in congestion and rhinorrhea , in the group of patients using isotonic seawater solution , other symptoms showed no major changes during the study period .
CONCLUSIONS	Hypertonic seawater solution has been proven to be better than isotonic seawater solution in eliminating the symptoms of nasal congestion , rhinorrhea , cough , headache and waking up during the night .

###23796045
OBJECTIVE	Sildenafil has been shown to preserve alveolar growth and lung angiogenesis in a rat model of bronchopulmonary dysplasia .
OBJECTIVE	We conducted a proof-of-concept randomised controlled pilot study to assess the feasibility of oral sildenafil treatment in extremely preterm infants with evolving bronchopulmonary dysplasia .
METHODS	Preterm infants < 28 weeks gestational age were eligible if they were mechanically ventilated on day 7 of life .
METHODS	Infants were randomised to a 4-weeks course of either oral sildenafil ( 3mg/kg/day ) or placebo solution .
METHODS	Pre-discharge cardiorespiratory outcomes and medication side effects were collected .
RESULTS	Twenty infants were randomised , 10 received sildenafil ( mean gestational age 24 +5 weeks ( SD 4.9 days ) , mean weight 692g ( SD 98 ) ) and 10 received placebo ( mean gestational age 24 +5 weeks ( SD 6.5 days ) , mean weight 668g ( SD 147 ) ) .
RESULTS	One infant in the sildenafil group did not receive treatment because of an early pneumoperitoneum .
RESULTS	Two infants did not complete the study ( transferred out ) .
RESULTS	Of the remaining seven treated infants , three died ( two from respiratory-related causes ) .
RESULTS	One infant in the control group died from a non-respiratory cause .
RESULTS	Sildenafil did not reduce length of invasive ( median 688 versus 227h ) or non-invasive ventilation ( median 1609 versus 1416h ) .
RESULTS	More infants in the sildenafil group required postnatal steroid treatment .
RESULTS	One infant developed hypotension following sildenafil administration and was excluded after three doses .
CONCLUSIONS	In this pilot study , oral sildenafil treatment did not improve any short-term respiratory outcomes in extremely preterm infants .

###10585037
BACKGROUND	Various blood management strategies can be used to reduce the need for allogeneic blood in cardiac surgery .
BACKGROUND	In anemic patients , however , avoidance of allogeneic blood transfusion is difficult to achieve .
BACKGROUND	This study was performed to assess the safety and effectiveness of preoperative blood collection using recombinant human erythropoietin ( rHuEPO ) for reducing the exposure to allogeneic blood in anemic patients .
METHODS	Thirty-two anemic patients undergoing cardiac surgery at our hospital between January 1994 and October 1997 were divided into two groups according to preoperative strategies : 3-week treatment with rHuEPO and blood donation ( group 1 , n = 16 ) or iron supplementation alone ( group 2 , n = 16 ) .
RESULTS	There were no statistically significant differences between the two groups in patients ' characteristics and surgical data .
RESULTS	The number of reticulocytes was increased at just before surgery in group 1 , whereas group 2 showed no significant increase .
RESULTS	The estimated hemoglobin increases in group 1 were higher at 7 days and just before surgery .
RESULTS	The mean number of required allogeneic blood for patients during surgery was 0.59 + / - 1.12 U in group 1 and 5.01 + / - 2.63 U in group 2 .
RESULTS	In 75 % of group 1 patients , allogeneic blood transfusion was successfully avoided , whereas all patients in group 2 received allogeneic blood .
CONCLUSIONS	This study suggests that the combination of rHuEPO administration and autologous blood donation can reduce the need for allogeneic blood in anemic patients .

###20399994
BACKGROUND	Cross-study comparisons suggest that systemic exposure ( AUC ) to rosuvastatin calcium , a 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitor , may be approximately 2-fold higher in Asian subjects living in Asian countries than in white subjects living in Western countries .
OBJECTIVE	This study was conducted to determine the pharmacokinetic characteristics of rosuvastatin and its metabolites after single and multiple doses of rosuvastatin in healthy Chinese subjects living in China .
METHODS	This was an open-label , ascending single - and multiple-dose study .
METHODS	Subjects were randomly assigned to receive rosuvastatin 5 , 10 , or 20 mg .
METHODS	Each subject received 1 tablet of the assigned treatment on day 1 and days 4 through 10 .
METHODS	Plasma concentrations of rosuvastatin , N-desmethyl rosuvastatin , and rosuvastatin lactone were measured through 72 hours after administration of single doses and through 96 hours after administration of multiple doses .
METHODS	Blood samples were obtained within 30 minutes before dosing on days 7 , 8 , and 9 for the assessment of pharmacokinetic parameters at steady state .
METHODS	Noncompartmental pharmacokinetic analysis was performed to determine the C ( max ) and AUC ( 0-t ) for rosuvastatin , N-desmethyl rosuvastatin , and rosuvastatin lactone after single and multiple doses of rosuvastatin .
METHODS	Tolerability assessments were conducted throughout the study .
RESULTS	Of the 36 enrolled subjects , only 1 was female .
RESULTS	The mean age of subjects in the rosuvastatin 5 - , 10 - , and 20-mg groups was 22.4 , 21.3 , and 22.4 years , respectively .
RESULTS	Weight and height ranged from 54 to 85 kg and from 161 to 189 cm , respectively .
RESULTS	Geometric mean C ( max ) values for rosuvastatin after administration of single doses of rosuvastatin 5 , 10 , and 20 mg were 8.33 , 10.76 , and 19.17 ng/mL , respectively ; the corresponding geometric mean AUC ( 0-t ) values were 57.63 , 88.89 , and 163.87 ng .
RESULTS	h/mL .
RESULTS	At steady state , values for C ( max ) were 8.31 , 8.41 , and 20.73 ng/mL ; the corresponding geometric mean AUC values were 64.87 , 77.29 , and 178.64 ng .
RESULTS	h/mL .
RESULTS	After administration of multiple doses of rosuvastatin 5 , 10 , and 20 mg , the accumulation ratios were 1.23 , 0.95 , and 1.23 , respectively , indicating minimal accumulation of rosuvastatin .
RESULTS	Circulating concentrations of N-desmethyl rosuvastatin and rosuvastatin lactone were well below those of rosuvastatin after administration of single and multiple doses of rosuvastatin .
CONCLUSIONS	Increases in C ( max ) , AUC ( 0-t ) , C ( max , ss ) , and AUC ( ss ) were observed with increasing single and multiple doses of rosuvastatin 5 , 10 , and 20 mg .
CONCLUSIONS	The increase in exposure with increasing doses was lower than would be expected under conditions of strict proportionality .
CONCLUSIONS	Rosuvastatin exhibited little accumulation on repeated administration .
CONCLUSIONS	All rosuvastatin doses were well tolerated in these Chinese subjects .

###22544562
BACKGROUND	This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practices of breast and prostate cancer survivors .
BACKGROUND	The relationship between change in self-efficacy and long-term physical activity ( PA ) also was examined .
METHODS	Breast and prostate cancer survivors ( N = 543 ) from 39 US states and two Canadian provinces participated in the FRESH START intervention trial .
METHODS	Participants were randomly assigned to receive a 10-month program of mailed print materials on diet and PA available in the public domain or a 10-month program of tailored materials designed to increase fruit and vegetable ( F&V ) intake , decrease fat intake , and/or increase PA. .
METHODS	Changes in self-efficacy for F&V intake and fat restriction were analyzed as potential mediators of the intervention 's effects on diet at 2-year follow-up .
METHODS	Because we previously found that change in self-efficacy for PA did not vary by group assignment , the relationship between change in self-efficacy and PA at 2-year follow-up was examined across study conditions .
RESULTS	Results suggest that change in self-efficacy for fat restriction partially explained the intervention 's effect on fat intake ( mean indirect effect = -0.28 ) , and change in self-efficacy for F&V consumption partially explained the intervention 's effect on daily F&V intake ( mean indirect effect = .11 ) .
RESULTS	Change in self-efficacy for fat restriction partially accounted for the intervention 's impact on overall diet quality among men only ( mean indirect effect = 0.60 ) .
RESULTS	Finally , change in self-efficacy for PA predicted PA at 2-year follow-up .
CONCLUSIONS	Findings suggest that self-efficacy may influence long-term maintenance of healthy lifestyle practices among cancer survivors .

###23510972
BACKGROUND	Currently , in developing countries , there is considerable interest in using mobile phones as job-aids for community health workers ( CHWs ) to improve the care they provide .
BACKGROUND	However , acceptance of new technologies can be inhibited if the workload imposed is perceived as excessive compared to existing methods .
OBJECTIVE	To compare perceived workload of CHWs using clinical care guidelines presented on mobile phones versus using conventional paper-based guidelines .
METHODS	Validated clinical practice guidelines were developed as Interactive Structured Rich-Medical guidelines ( ISRMGs ) on Windows Mobile 6.5 mobile phones .
METHODS	A prospective randomized controlled study was performed in Colombia in which 50 CHWs used the ISRMGs , and paper-based materials with the same information , in a cross-over design to diagnose and treat 15 matched pairs of medical cases presented on Human Patient simulators .
METHODS	The NASA Task Load Index , a validated measure of perceived workload , was administered and results compared by means of a mixed model analysis .
RESULTS	When using the ISRMGs on mobile phones the health workers reported statistically significant decreases in mental demand , frustration , and overall workload as compared to using paper-based job-aids .
CONCLUSIONS	Use of ISRMGs on mobile phones by community health workers in developing countries has the potential to decrease their perceived workload , fatigue , and enhance their ability to provide better care for more patients .

###18046186
OBJECTIVE	To determine the effect of a 12-month moderate resistance training program on phenotypic and functional immunological parameters of previously sedentary , clinically healthy , elderly women .
METHODS	A total of 42 clinically healthy , sedentary females ( aged 60-77 yr old ) were randomly assigned to either a moderate-intensity resistance training program or a control group during a 12-month longitudinal , randomized , controlled , intervention study .
METHODS	Resistance training program consisted of three sets of 12 repetitions at 54.9 + / - 2.4 % 1RM for five different exercises performed three times per week during 12 months .
METHODS	Natural killer cell cytotoxic activity ( NKCA ) , lymphoproliferative response to the mitogen phytohemaglutinin ( PHA ) , and quantification of the lymphocytes ( CD3 , CD3CD19 , CD56 ) and subpopulations ( CD4 , CD8 , CD56 , CD56 ) as well as cellular expression molecules ( CD25 , CD28 , CD45RA , CD45RO , CD69 , CD95 , HLA-DR ) were determined by immunological assays .
RESULTS	The experimental group increased muscle strength in 44 % and 48 % after 6 and 12 months , respectively ( P < 0.05 ) .
RESULTS	There were no statistically significant differences between the groups or according to the time for quantitative ( CD3 , CD3CD19 , CD56 , CD4 , CD8 , CD45RA , CD45RO , CD56 , CD56 , CD95 , CD28 , CD25 , CD69 , HLA-DR ) and functional immunological parameters ( natural killer cell cytotoxic activity and lymphoproliferative response ) .
CONCLUSIONS	A 12-month moderate resistance training program increases muscle strength , but it does not change immune phenotypic and functional parameters of previously sedentary , clinically healthy , elderly women .

###20117379
OBJECTIVE	The aim of this study was to evaluate whether addition of omega-3 fatty acids or increase in aspirin dose improves response to low-dose aspirin among patients who are aspirin resistant .
BACKGROUND	Low response to aspirin has been associated with adverse cardiovascular events .
BACKGROUND	However , there is no established therapeutic approach to overcome aspirin resistance .
BACKGROUND	Omega-3 fatty acids decrease the availability of platelet arachidonic acid ( AA ) and indirectly thromboxane A2 formation .
METHODS	Patients ( n = 485 ) with stable coronary artery disease taking low-dose aspirin ( 75 to 162 mg ) for at least 1 week were screened for aspirin response with the VerifyNow Aspirin assay ( Accumetrics , San Diego , California ) .
METHODS	Further testing was performed by platelet aggregation .
METHODS	Aspirin resistance was defined by > or = 2 of 3 criteria : VerifyNow score > or = 550 , 0.5-mg / ml AA-induced aggregation > or = 20 % , and 10-micromol/l adenosine diphosphate ( ADP ) - induced aggregation > or = 70 % .
METHODS	Thirty patients ( 6.2 % ) were found to be aspirin resistant and randomized to receive either low-dose aspirin + omega-3 fatty acids ( 4 capsules daily ) or aspirin 325 mg daily .
METHODS	After 30 days of treatment patients were re-tested .
RESULTS	Both groups ( n = 15 each ) had similar clinical characteristics .
RESULTS	After treatment significant reductions in AA - and ADP-induced aggregation and the VerifyNow score were observed in both groups .
RESULTS	Plasma levels of thromboxane B2 were also reduced in both groups ( 56.8 % reduction in the omega-3 fatty acids group , and 39.6 % decrease in the aspirin group ) .
RESULTS	Twelve patients ( 80 % ) who received omega-3 fatty acids and 11 patients ( 73 % ) who received aspirin 325 mg were no longer aspirin resistant after treatment .
CONCLUSIONS	Treatment of aspirin-resistant patients by adding omega-3 fatty acids or increasing the aspirin dose seems to improve response to aspirin and effectively reduces platelet reactivity .

###14499752
OBJECTIVE	Scopolamine , a muscarinic receptor antagonist , can produce temporary cognitive impairments as well as electroencephalographic changes that partially resemble those observed in Alzheimer 's disease .
OBJECTIVE	In order to test the sensitivity of spectral power and hemispheric coherence to changes in cholinergic transmission , we evaluated quantitative magnetoencephalogram ( MEG ) after intravenous injection of scopolamine .
METHODS	MEG of 8 elderly healthy subjects ( 59-80 years ) were measured with a whole-head magnetometer after intravenous injection of scopolamine .
METHODS	An injection of glycopyrrolate , a peripheral muscarinic antagonist , was used as the placebo in a double-blind , randomized , cross-over design .
METHODS	Spectral power and coherence were computed over 7 brain regions in 3 frequency bands .
RESULTS	Scopolamine administration increased theta activity ( 4-8 Hz ) and resulted in the abnormal pattern of MEG desynchronization in eyes-open vs. eyes-closed conditions in the alpha band ( 8-13 Hz ) .
RESULTS	These effects were most prominent over the posterior regions .
RESULTS	Interhemispheric and left intrahemispheric coherence was significantly decreased in the theta band ( 4-8 Hz ) .
CONCLUSIONS	Spontaneous cortical activity at the theta and alpha range and functional coupling in the theta band are modulated by the cholinergic system .
CONCLUSIONS	MEG may provide a tool for monitoring brain dynamics in neurological disorders associated with cholinergic abnormalities .

###15793648
OBJECTIVE	A randomized trial was undertaken to evaluate and compare stapled hemorrhoidopexy with excisional hemorrhoidectomy in which the Harmonic Scalpel was used .
METHODS	Patients with Grade III hemorrhoids who were employed during the trial period were recruited and randomized into two groups : ( 1 ) Harmonic Scalpel hemorrhoidectomy , and ( 2 ) stapled hemorrhoidopexy .
METHODS	All operations were performed by a single surgeon .
METHODS	In the stapled group , the doughnut obtained was sent for histopathologic examination to determine whether smooth muscles were included in the specimen .
METHODS	Operative data and complications were recorded , and patients were followed up through a structured pro forma protocol .
METHODS	An independent assessor was assigned to obtain postoperative pain scores and satisfaction scores at six-month follow-up .
METHODS	Patients were also administered a simple questionnaire at follow-up to assess continence functions .
RESULTS	Over a 20-month period , 88 patients were recruited .
RESULTS	The two groups were matched for age and gender distribution .
RESULTS	No significant difference was identified between the two groups in terms of operation time , blood loss , day of first bowel movement after surgery , and complication rates .
RESULTS	Despite a similar parenteral and oral analgesic requirement , the stapled group had a significantly better pain score ( P = 0.002 ) ; these patients also had a significantly shorter length of stay ( P = 0.02 ) , and on average resumed work nine days earlier than the group treated with the Harmonic Scalpel ( 6.7 vs. 15.6 , P = 0.002 ) .
RESULTS	Although 88 percent of doughnuts obtained in the stapled group contained some smooth muscle fibers , no association was found between smooth muscle incorporation and postoperative continence function , and as a whole the continence outcomes of the stapled group were similar to those after Harmonic Scalpel hemorrhoidectomy .
RESULTS	Finally , at six-month follow-up , patients who underwent the stapled procedure had significantly better satisfaction scores ( P = 0.001 ) .
CONCLUSIONS	Stapled hemorrhoidopexy is a safe and effective procedure for Grade III hemorrhoidal disease .
CONCLUSIONS	Patients derive greater short-term benefits of reduced pain , shorter length of stay , and earlier resumption to work .
CONCLUSIONS	Long-term follow-up is necessary to determine whether these initial results are lasting .

###20362857
OBJECTIVE	To compare visual outcomes and changes in total higher-order aberrations ( HOAs ) between conventional photorefractive keratectomy ( PRK ) and custom PRK SETTING : Department of Ophthalmology , Labbafinejad Medical Center , Ophthalmic Research Center , Shahid Beheshti University of Medical Sciences and Negah Eye Center , Tehran , Iran .
METHODS	This clinical trial comprised eyes having bilateral myopic PRK with the Technolas 217z excimer machine .
METHODS	One eye had conventional ablation ( conventional group ) and the other eye , wavefront-guided custom treatment ( custom group ) .
METHODS	Changes in postoperative visual acuity , cycloplegic refraction , contrast sensitivity function , and root mean square higher-order aberrations ( RMS HOAs ) were compared between the 2 groups .
RESULTS	The mean age of the 28 patients ( 56 eyes ) was 26.7 years .
RESULTS	The mean preoperative cycloplegic spherical equivalent refractive error was -4.92 diopters ( D ) + / - 1.6 ( SD ) and the mean refractive astigmatism , 0.91 + / - 1.0 D.
RESULTS	There was no statistically significant difference between the 2 groups in preoperative cycloplegic refractive error , HOAs , or contrast sensitivity function .
RESULTS	The mean follow-up was 8.1 + / - 3.3 months .
RESULTS	The increase in RMS HOAs from preoperatively to postoperatively was statistically significantly higher in the custom group in the 6.0 mm zone ( P = .03 ) but not in the 4.0 mm zone ( P = .26 ) .
RESULTS	The decrease in low mesopic contrast sensitivity function was statistically significant in both groups .
CONCLUSIONS	The RMS HOAs significantly increased after PRK with both methods .
CONCLUSIONS	The results suggest that custom ablation is more sensitive to optical zone ( OZ ) size and may yield more aberrations with an OZ smaller than 6.0 mm .

###16846555
OBJECTIVE	To evaluate the efficacy and safety of levalbuterol metered dose inhaler ( MDI ) in children aged 4-11 years ( n = 173 ) .
METHODS	Multicenter , randomized , double-blind 28-day study of QID levalbuterol 90 microg , racemic albuterol 180 mug , and placebo ( 2:1:1 ratio ) .
METHODS	Serial spirometry was performed on Days 0 , 14 , and 28 .
METHODS	The primary endpoint was the double-blind average peak percent ( % ) change in FEV ( 1 ) from visit pre-dose ; the primary comparison was with placebo .
METHODS	Secondary endpoints included the area under the FEV ( 1 ) percent change from pre-dose curve and peak % predicted FEV ( 1 ) .
METHODS	Safety endpoints included adverse events , laboratory tests , rescue medication use , and electrocardiograms .
RESULTS	Levalbuterol significantly improved the least square mean peak percent change in FEV ( 1 ) compared with placebo ( levalbuterol 25.6 % + / - 1.3 % [ p < 0.001 ] ; racemic albuterol 21.8 % + / - 1.8 % [ p = ns ] ; placebo 16.8 % + / - 1.9 % ) .
RESULTS	Results for levalbuterol were similar for the other spirometry endpoints ( p < 0.05 vs. placebo ) .
RESULTS	No levalbuterol-treated patients had a peak percent change in FEV ( 1 ) < 10 % ( compared with 15.8 % of racemic albuterol-treated patients and 30.3 % of placebo-treated patients ) .
RESULTS	The incidence of adverse events was 43.4 % for levalbuterol , 56.4 % for racemic albuterol , and 51.4 % for placebo .
RESULTS	The rate of discontinuation was 1.3 % for levalbuterol , 2.6 % for racemic albuterol , and 8.6 % for placebo .
RESULTS	The rate of asthma attacks ( 10.5 % , 12.8 % , 14.3 % , respectively ) was similar among treatments .
RESULTS	Levalbuterol and racemic albuterol both reduced rescue medication use ( p < 0.01 vs. placebo ) and produced changes in ventricular heart rate and QT ( c-F ) that were similar to placebo .
CONCLUSIONS	In this study , levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo .

###18829079
OBJECTIVE	To introduce a new and easy technique to perform laparoscopic vesicourethral anastomosis with a single-suture , single-knot , running procedure .
METHODS	We have performed 350 laparoscopic radical prostatectomies .
METHODS	In a prospective study , we evaluated a new anastomosis technique in 50 consecutive cases .
METHODS	A multiple knot is prepared at 4 cm from the end of a suture .
METHODS	Then the running suture is started at the bladder neck at 4 o'clock .
METHODS	The posterior plate is maintained open for the first throws , and the suture is pulled only after the third passage at the bladder neck .
METHODS	Then the running suture is completed clockwise and finally tied to the 4-cm tail .
RESULTS	Use of this technique in 50 patients was compared with use of a double running suture in 50 other patients .
RESULTS	The 2 groups were comparable .
RESULTS	The new procedure was related to a decreased anastomotic time , without complications , with no leak at catheter removal at postoperative day 5 or 6 .
CONCLUSIONS	The experience with this original anastomosis is still preliminary , but the results are very promising , and we would like to propose it to laparoscopic urologists .

###24564888
BACKGROUND	Triple negative breast cancer ( TNBC ) has higher rates of recurrence and distant metastasis , and poorer outcome as compared to non-TNBC .
BACKGROUND	Aberrant activation of WNT signaling has been detected in TNBC , which might be important for triggering oncogenic conversion of breast epithelial cell .
BACKGROUND	Therefore , we directed our focus on identifying the WNT ligand and its underlying mechanism in TNBC cells .
METHODS	We performed large-scale analysis of public microarray data to screen the WNT ligands and the clinical significance of the responsible ligand in TNBC .
METHODS	WNT5B was identified and its overexpression in TNBC was confirmed by immunohistochemistry staining , Western blot and ELISA .
METHODS	ShRNA was used to knockdown WNT5B expression ( shWNT5B ) .
METHODS	Cellular functional alteration with shWNT5B treatment was determined by using wound healing assay , mammosphere assay ; while cell cycle and apoptosis were examined by flowcytometry .
METHODS	Mitochondrial morphology was photographed by electron microscope .
METHODS	Biological change of mitochondria was detected by RT-PCR and oxygen consumption assay .
METHODS	Activation of WNT pathway and its downstream targets were evaluated by liciferase assay , immunohistochemistry staining and immunoblot analysis .
METHODS	Statistical methods used in the experiments besides microarray analysis was two-tailed t-test .
RESULTS	WNT5B was elevated both in the tumor and the patients ' serum .
RESULTS	Suppression of WNT5B remarkably impaired cell growth , migration and mammosphere formation .
RESULTS	Additionally , G0/G1 cell cycle arrest and caspase-independent apoptosis was observed .
RESULTS	Study of the possible mechanism indicated that these effects occurred through suppression of mitochondrial biogenesis , as evidenced by reduced mitochondrial DNA ( MtDNA ) and compromised oxidative phosphorylation ( OXPHOS ) .
RESULTS	In Vivo and in vitro data uncovered that WNT5B modulated mitochondrial physiology was mediated by MCL1 , which was regulated by WNT / - catenin responsive gene , Myc .
RESULTS	Clinic data analysis revealed that both WNT5B and MCL1 are associated with enhanced metastasis and decreased disease-free survival .
CONCLUSIONS	All our findings suggested that WNT5B/MCL1 cascade is critical for TNBC and understanding its regulatory apparatus provided valuable insight into the pathogenesis of the tumor development and the guidance for targeting therapeutics .

###9019175
OBJECTIVE	Rocuronium is a new non-depolarising steroidal muscle relaxant with a short onset time .
OBJECTIVE	The present study was undertaken to compare intubating conditions as well as onset and clinical duration of a single dose of 0.6 mg/kg ( 2 x ED95 ) with a single dose of 1 mg/kg suxamethonium ( 3 x ED95 ) .
METHODS	After obtaining informed consent and approval of the Ethics Committee , 40 adult patients ( ASA I-III ) participated in this study .
METHODS	After premedication with oxazepam , anaesthesia was induced with fentanyl and propofol and maintained with propofol , N2O and supplements of fentanyl as needed .
METHODS	Muscular relaxation was assessed by EMG recording of adductor pollicis muscle after supramaximal single twitch stimulation of the ulnar nerve every 10 s. Patients were allocated randomly to receive either rocuronium 0.6 mg/kg or suxamethonium 1 mg/kg .
METHODS	The following parameters were measured : intubating conditions 60 s after injection , onset time and clinical duration of neuromuscular block , % block at intubation , heart rate , blood pressure and arterial oxygen saturation .
RESULTS	( mean + / - SD ) .
RESULTS	Intubating conditions after rocuronium and suxamethonium were found to be clinically acceptable ( excellent or good ) in 90 % of patients , though there was only a partial blockade of the adductor pollicis muscle with rocuronium ( 71 + / - 23 % ) compared to suxamethonium ( 95 + / - 14 % ) ( p < 0.05 ) .
RESULTS	The onset time and clinical duration of relaxation was shorter after suxamethonium ( p < 0.05 ) and occurred at 0.8 + / - 0.2 , 7 + / - 2.1 and 3.2 + / - 1.3 , 29 + / - 11 min after suxamethonium and rocuronium respectively .
CONCLUSIONS	At a dosage of 0.6 mg/kg , rocuronium has an onset time of about 3 min and a clinical duration of relaxation of nearly half an hour .
CONCLUSIONS	These data are supported by various studies , while others show shorter times , probably due to different monitoring techniques .
CONCLUSIONS	In spite of the pharmacodynamic differences between suxamethonium and rocuronium , the intubating conditions after administration of both compounds are comparable and develop at the same rate .

###23032981
OBJECTIVE	The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation ( TENS ) is being increasingly used to treat fecal incontinence ( FI ) , its efficacy has never been proved using controlled trials .
METHODS	In this randomized , double-blind , sham-controlled trial , 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months .
METHODS	The primary end point was the response to treatment based on the number of incontinence and urgency episodes .
METHODS	Secondary end points were severity scores , quality of life scores , delay to postpone defecation , patient self-assessment of treatment efficacy , physician assessment of TENS efficacy , anorectal manometry , and adverse events .
RESULTS	No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week .
RESULTS	Thirty-four patients ( 47 % ) who received the active TENS treatment exhibited a > 30 % decrease in the FI severity score compared with 19 patients ( 27 % ) who received the sham treatment ( odds ratio 2.4 , 95 % confidence interval 1.1-5 .1 , P = 0.02 ) .
RESULTS	No differences in delay to postpone defecation , patient self-assessment of treatment efficacy , or anorectal manometry were seen between the two groups .
RESULTS	The evaluating physicians rated the active stimulations as more effective than the sham stimulations ( P = 0.01 ) .
RESULTS	One minor therapy-related adverse event was observed ( 1.5 % ) ( see Supplementary Consort 1b ) .
CONCLUSIONS	We failed to demonstrate any benefit of TENS on our primary end-point .

###20805256
OBJECTIVE	To assess the association between antidepressant medicine use and risk of developing diabetes during the Diabetes Prevention Program ( DPP ) and Diabetes Prevention Program Outcomes Study ( DPPOS ) .
METHODS	DPP/DPPOS participants were assessed for diabetes every 6 months and for antidepressant use every 3 months in DPP and every 6 months in DPPOS for a median 10.0-year follow-up .
RESULTS	Controlled for factors associated with diabetes risk , continuous antidepressant use compared with no use was associated with diabetes risk in the placebo ( adjusted hazard ratio 2.34 [ 95 % CI 1.32-4 .15 ] ) and lifestyle ( 2.48 [ 1.45-4 .22 ] ) arms , but not in the metformin arm ( 0.55 [ 0.25-1 .19 ] ) .
CONCLUSIONS	Continuous antidepressant use was significantly associated with diabetes risk in the placebo and lifestyle arms .
CONCLUSIONS	Measured confounders and mediators did not account for this association , which could represent a drug effect or reflect differences not assessed in this study between antidepressant users and nonusers .

###14748464
OBJECTIVE	Nausea and vomiting remain the most distressing side effects of cancer chemotherapy .
OBJECTIVE	The present study aimed to study the efficacy and tolerability of ondansetron versus ( vs ) metoclopramide in different dose related grades of cisplatin induced acute emesis .
METHODS	A total of 137 patients were enrolled and 80 completed the study .
METHODS	Cisplatin 60 mg/m2 was given intravenously ( iv ) either as a single dose on day 1 ( high dose regimen ) or in three doses of 20 mg/m2 each on days 1-3 ( low dose regimen ) along with bleomycin +5 - flurouracil in 40 patients each .
METHODS	Patients were randomized in each cisplatin regimen to receive either 20 mg metoclopramide ( 20 patients ) or 8 mg ondansetron ( 20 patients ) iv 30 min prior to cisplatin administration followed by 20 mg metoclopramide or 8 mg ondansetron orally 8 h respectively for 24 h after the last cisplatin administration .
METHODS	Ten patients receiving high dose cisplatin in each group were also given dexamethasone 8 mg iv with the primary antiemetic .
METHODS	Patients were assessed for 24 h after the last cisplatin injection .
RESULTS	In low dose cisplatin regimen , complete suppression of acute emesis occurred in 65 per cent patients receiving ondansetron versus 30 per cent receiving metoclopramide , while in high dose regimen , complete response rate was 20 per cent with ondansetron versus 0 per cent with metoclopramide .
RESULTS	Dexamethasone significantly augmented the antiemetic efficacy of metoclopramide but not that of ondansetron .
RESULTS	Protection from nausea in the acute phase was seen in 95 per cent patients receiving ondansetron vs 70 per cent receiving metoclopramide in low dose regimen .
RESULTS	With high dose the protection rates were 90 vs 0 per cent respectively .
RESULTS	Combination of dexamethasone + metoclopramide achieved 70 per cent protection while dexamethasone + ondansetron was effective in 90 per cent .
RESULTS	Dropouts and withdrawals were more among patients receiving high dose cisplatin and antiemetic regimens without dexamethasone .
RESULTS	Thirty nine adverse events were reported by 20 out of 80 patients .
RESULTS	All adverse events were mild .
CONCLUSIONS	The results demonstrate dose related emetogenicity of cisplatin and superior antiemetic efficacy of ondansetron , especially against high dose cisplatin regimen .
CONCLUSIONS	Dexamethasone potentiated efficacy of metoclopramide but not that of ondansetron .
CONCLUSIONS	The combination of metoclopramide plus dexamethasone was found to be as efficacious as ondansetron monotherapy .

###19222851
BACKGROUND	Endothelial dysfunction is a hallmark of sepsis , associated with lung transvascular fluid flux and pulmonary dysfunction in septic patients .
BACKGROUND	We tested the hypothesis that methicillin-resistant Staphylococcus aureus ( MRSA ) sepsis following smoke inhalation increases pulmonary transvascular fluid flux via excessive nitric oxide ( NO ) production .
METHODS	Ewes were chronically instrumented , and randomised into either a control or MRSA sepsis ( MRSA and smoke inhalation ) group .
RESULTS	Pulmonary function remained stable in the control group , whereas the MRSA sepsis group developed impaired gas exchange and significantly increased lung lymph flow , permeability index and bloodless wet-to-dry weight-ratio ( W/D ratio ) .
RESULTS	The plasma nitrate/nitrite ( NOx ) levels , lung inducible nitric oxide synthases ( iNOS ) and endothelial nitric oxide synthases ( eNOS ) , vascular endothelial growth factor ( VEGF ) protein expressions and poly - ( ADP ) - ribose ( PAR ) were significantly increased by MRSA challenge .
CONCLUSIONS	These results provide evidence that excessive NO production may mediate pulmonary vascular hyperpermeability in MRSA sepsis via up regulation of reactive radicals and VEGF .

###22353992
OBJECTIVE	In patients with carpal tunnel syndrome ( CTS ) , a proximal stimulus can sometimes evoke typical symptoms .
OBJECTIVE	Explanations for this phenomenon include local disturbance of arterial circulation , stimulation of trigger points , and the double crush syndrome ( DCS ) .
OBJECTIVE	The aim of this study was to investigate the value of these hypotheses with a new provocation test performed on the infraspinatus muscle ( infraspinatus test [ IsT ] ) in a multiple-blind , controlled study .
METHODS	Thirty-four subjects were recruited , tested with IsT , and measured with nerve conduction velocity ( NCV ) .
METHODS	Additionally , the Tinel sign ( TS ) was examined .
METHODS	The McNemar test was used to compare the IsT and NCV with the subjects ' symptoms .
METHODS	The Fisher exact test was used to correlate IsT and symptoms .
RESULTS	In the McNemar test , IsT showed no significant difference to the NCV ( P = 0.18 , sensitivity : 69.7 % , specificity : 87.1 % ) regarding the subjects ' symptoms ( P = 0.2888 , sensitivity 80.6 % , specificity 93.9 % ) .
RESULTS	The Fisher exact test proved the significance of the IsT with regard to symptoms ( P < 0.0001 ) .
CONCLUSIONS	Pressure exerted on a certain point of the infraspinatus muscle has significant diagnostic power and may be a valuable clinical test in everyday practice .
CONCLUSIONS	We discuss the arguments for and against a new , latent trigger point and whether other mechanisms may play a role .

###21517230
BACKGROUND	Breast cancer is the most common malignancy in women .
BACKGROUND	Early diagnosis allows efficient treatment and increases survival , but the efficacy of breast self examination ( BSE ) is not sufficiently well established .
BACKGROUND	The American Cancer Society aims to give women the opportunity to recognize the utility , limitations and adverse effects of breast cancer screening through education models based on psychological theories .
BACKGROUND	With the Health Belief Model , people 's health perceptions and attitudes influence their practices , for example with screening .
OBJECTIVE	The purpose of this randomized controlled clinical trial was to determine the effect of education based on this model on breast cancer screening in high risk Iranian women .
METHODS	Participants were women with a family history of breast cancer ( mother , sister , and daughter ) .
METHODS	After explanation of the study objectives to participants , they were recruited on obtaining oral consent and each filled out the study questionnaire based on the Health Belief Model .
METHODS	Allocation was into two groups by computerized randomization , control and intervention , receiving education on breast cancer screening .
METHODS	Perceived susceptibility to and seriousness of breast cancer , perceived usefulness of and barriers to BSE , clinical breast examination , and mammography , and self-efficacy in the ability to perform these , were assessed , with comparison of scores for BSE practice before and after education and doing mammography and clinical examination by a physician in intervention and control group .
RESULTS	The mean age was 37.8 11.7 ( range 19-60 ) .
RESULTS	The mean rank in the intervention group significantly differed before and after the education , but except for '' perceived threat '' and `` perceived usefulness of breast self examination '' , we did not find any significant differences from the control group .
RESULTS	After educational sessions , breast self examination and clinical examination practice rates were elevated .
CONCLUSIONS	Health education based on well known psychological theories for breast cancer screening should be extended to the entire populations in developing countries .
CONCLUSIONS	In addition , we should pay attention to barriers to women undergoing mammography , such as costs , shame and accessibility , and increase the target population awareness and positive attitudes towards benefits of early breast cancer screening .

###19902755
OBJECTIVE	To explore the analgesic effect of electroacupuncture ( EA ) combined with acupoint-injection in treating lumbar intervertebral disc herniation .
METHODS	Sixty patients with lumbar intervertebral disc herniation were divided randomly into treatment group ( 30 cases , group A ) and control group ( 30 cases , group B ) according to random digits table .
METHODS	Involved 31 males and .
METHODS	29 females in the study , the age was from 35 to 62 years with an average of 48.3 years .
METHODS	The patients in group A were treated with EA ( once a day , a total of 10 times ) and acupoint-injection ( once every two days , a total of 5 times ) at L4 Jiaji ( EX-B2 ) , L5 Jiaji ( EX-B2 ) , Zhibian ( BL54 ) , Huantiao ( GB30 ) , Yanglingquan ( GB34 ) , Weizhong ( BLA0 ) and Kunlun ( BL60 ) ; and the patients in group B were treated with single EA ( Once a day , a total of 10 times ) .
METHODS	After 10 days of treatment , the visual analogue scale ( VAS ) was adopted to examine and compare the main pain score , and the clinical effects were compared between two groups from the symptoms and signs in accordance with efficacy criteria .
RESULTS	The paregoric effect of group A was better than that of group B , there was significant differences in the main pain score between two groups ( t = 7.18 , P < 0.01 ) .
RESULTS	The clinical effect of group A was better than that of group B , there was significant differences between two groups ( u = 2.91 , P < 0.01 ) .
CONCLUSIONS	EA combined with acupoint-injection is a convenient and highly effective therapy for lumbar intervertebral disc herniation , which can effectively relieve the pain of the patients , should be to promote clinical use .

###11484961
BACKGROUND	Both gemcitabine and etoposide are active in the treatment of small-cell lung cancer ( SCLC ) , and are characterised by mild toxicity profiles .
BACKGROUND	The combination of both drugs was found to be feasible and active in a phase I dose-finding study in solid tumours .
BACKGROUND	Therefore , a phase II trial was initiated to examine the activity and toxicity of this schedule in extensive disease SCLC .
METHODS	Forty-two chemo-nave extensive disease SCLC patients were enrolled to receive gemcitabine 1000 mg/m2 , days 1 , 8 and 15 , and etoposide 80 mg/m2 , days 8 , 9 and 10 of a 28-day cycle .
RESULTS	Thirty-seven patients were evaluable for efficacy ( five received less than one cycle ) .
RESULTS	No complete responses were observed , but partial responses were seen in 17 patients , yielding an overall response rate of 46 % .
RESULTS	The median duration of response was 5.8 months .
RESULTS	Disease stabilisation was obtained in another 10 patients ( 27 % ) .
RESULTS	The median survival of the 37 protocol-qualified patients was 10.5 months ( 95 % confidence interval ( CI ) : 7.5-12 .0 ) .
RESULTS	The levels of WHO grade 3 and 4 toxicities were low and clinically manageable .
CONCLUSIONS	In comparison with standard platinum-based regimens , this combination of gemcitabine and etoposide resulted in a somewhat lower response rate , but a similar median survival time .
CONCLUSIONS	Haematological toxicity was more pronounced than expected from the toxicity data of each agent individually .
CONCLUSIONS	However , because of its mild non-haematological toxicity , and its ability to be administered in an outpatient setting , this combination provides a reasonable palliative option for patients with extensive disease SCLC .

###11986086
OBJECTIVE	To evaluate the efficacy of cidofovir 1 % eyedrops with and without cyclosporin A 1 % eyedrops as a treatment of acute adenoviral keratoconjunctivitis ( AKC ) .
METHODS	Randomized , controlled trial .
METHODS	Thirty-four patients with acute adenoviral keratoconjunctivitis of recent onset .
METHODS	Patients were divided into 4 treatment groups : 1 ) cidofovir four times daily , 2 ) cidofovir 10 times daily , 3 ) cidofovir four times daily and cyclosporin A four times daily , and 4 ) sodium chloride four times daily ( control ) .
METHODS	The diagnosis was confirmed by adenoviral polymerase chain reaction from conjunctival swabs .
METHODS	Duration of treatment was 21 days .
METHODS	Severity of conjunctival injection , conjunctival chemosis , punctate epithelial keratitis during the course of treatment , and presence and severity of corneal subepithelial infiltrates were evaluated by a clinical score .
METHODS	Duration until subjective improvement of symptoms was recorded .
RESULTS	The frequency of severe corneal opacities was lower with cidofovir ( P = 0.048 ) .
RESULTS	Cidofovir was toxic locally to the skin of the eyelids and the conjunctiva in a dose-dependent manner .
RESULTS	Symptoms of local toxicity were clinically similar to the signs of the initial viral inflammation .
RESULTS	They first appeared 8 to 12 days after beginning of treatment and completely subsided 7 to 28 days after discontinuation of cidofovir .
RESULTS	The outcome measures of local inflammation did not differ between the four treatment groups .
RESULTS	Cyclosporin A did not alter the course of the infection .
CONCLUSIONS	Cidofovir lowers the frequency of severe corneal opacities , but its clinical use 4 to 10 times daily at a 1 % concentration is limited by local toxicity .
CONCLUSIONS	Further clinical studies to find an efficacious yet tolerable dosage regimen of cidofovir , possibly using an improved pharmaceutical preparation , are required .

###18397716
OBJECTIVE	To evaluate the efficacy of oral mizoribine ( MZB ) pulse therapy given twice a week for frequently relapsing steroid-dependent nephrotic syndrome ( FR-SDNS ) .
METHODS	16 patients with FR-SDNS with a median age of 11.6 years ( range 5.1 17.8 years ) were enrolled in the study .
METHODS	This study was a Phase II trial .
METHODS	The dose of MZB was adjusted to achieve a peak blood level of about 3 microg/ml ( 10.0-19 .7 mg/kg/d , maximum total dose 750 mg ) in two divided doses given 2 days a week before a meal .
METHODS	The therapeutic benefits of MZB pulse therapy were assessed based on a comparison of the incidence of relapse ( times/year ) and the required daily dosage of prednisolone ( PSL ) before and after therapy .
RESULTS	The incidence of relapse after therapy was significantly lower than that before therapy ( 2.4 A + / - 1.6 vs. 3.4 A + / - 1.1 times/year , p < 0.05 ) , and the required daily dosage of PSL after therapy was lower than that before therapy ( 0.39 A + / - 0.26 vs. 0.47 A + / - 0.24 mg/kg/d ; not significant ) .
RESULTS	During the follow-up period , discontinuation of PSL was possible in 6 of 12 patients who showed a decreased rate of relapse after therapy .
RESULTS	The age at entry into the study and the peak blood concentration of MZB of these patients were significantly higher than in four patients who did not show a decreased rate of relapse ( 12.3 A + / - 4.3 vs. 7.9 A + / - 2.6 years , p < 0.05 ; 3.00 A + / - 0.93 vs. 1.97 A + / - 0.36 microg/ml , p < 0.005 , respectively ) .
RESULTS	No adverse effects were observed in any patients .
CONCLUSIONS	Our results show that MZB pulse therapy is effective in decreasing the frequency of relapse and reducing the required PSL dosage in older pediatric patients with FR-SDNS .

###23813113
OBJECTIVE	A prospective , randomized , double-masked , clinical trial was designed to evaluate distance and near contrast sensitivity ( CS ) in patients symmetrically , and randomly , implanted with 4 different multifocal intraocular lens ( MIOL ) designs ( ReSTOR SN6AD1 , ReSTOR SN60D3 , ReZoom NXG , and Tecnis ZMA00 ) and a monofocal control group ( Tecnis ZA9003 ) , 6 months after cataract intervention .
METHODS	Photopic , mesopic , and mesopic with glare distance CS , as well as photopic near CS , was evaluated with the CSV-1000 CS test and the Vistech VCTS 6000 system , respectively , in a group of 180 patients attending the ophthalmology department of Sant Pau Hospital , Barcelona , for cataract intervention and lens implantation .
RESULTS	Statistically and clinically significant differences were found between the monofocal and multifocal lens groups at all spatial frequencies and illumination conditions , both during distance and near CS evaluation ( all p < 0.05 ) , with the monofocal lens offering the best performance in all cases .
RESULTS	Contrast sensitivity was similarly compromised in all MIOL models at distance , although MIOLs with diffractive optics and aspheric profiles showed a non-statistically significant trend to perform better in mesopic conditions .
RESULTS	Near CS was lower for refractive , distance dominant lens designs , particularly at medium to high spatial frequencies .
CONCLUSIONS	The present results , which reflect intraocular lens ( IOL ) characteristics in optics , profile , and add power , may contribute to help surgeons decide on the type of IOL most suitable for each patient by taking into consideration the individual needs for critical distance and near vision , both in terms of visual acuity and contrast sensitivity .

###17426001
OBJECTIVE	To compare the efficacy of preemptive epidural analgesia combined with postoperative epidural analgesia , postoperative epidural analgesia alone and intravenous analgesia for postoperative pain relief and their effects on plasma interleukin-6 ( IL-6 ) concentration following radical surgery for gastric carcinoma .
METHODS	Sixty-six patients with gastric carcinoma scheduled for gastrectomy were randomly divided into 3 groups , namely group P ( n = 22 ) , group E ( n = 22 ) and group V ( n = 22 ) , to receive preemptive epidural analgesia combined with postoperative epidural analgesia , exclusive postoperative epidural analgesia , and exclusive postoperative intravenous analgesia , respectively .
METHODS	Hemodynamic data were recorded for all the patients during the operation , and visual analogue scale ( VAS ) was used to assess the pain intensity at 4 , 8 , 16 , 24 , 48 and 72 h after surgery .
METHODS	Plasma IL-6 concentration was determined before surgery and at 24 , 48 , 72 h after surgery .
RESULTS	No significant changes occurred in the hemodynamics during the preoperative periods .
RESULTS	VAS and IL-6 were lower in group P than in group E and V , and group E had lower measurement than group V ( P < 0.05 ) .
CONCLUSIONS	Preemptive epidural analgesia combined with postoperative epidural analgesia provides more satisfactory pain relief and more effectively prevents IL-6 increment than exclusive epidural analgesia or intravenous analgesia after gastrectomy for gastric carcinoma .

###9734786
OBJECTIVE	To evaluate an innovative approach to continuing medical education , an outreach intervention designed to improve performance rates of breast cancer screening through implementation of office systems in community primary care practices .
METHODS	Randomized , controlled trial with primary care practices assigned to either the intervention group or control group , with the practice as the unit of analysis .
METHODS	Twenty mostly rural counties in North Carolina .
METHODS	Physicians and staff of 62 randomly selected family medicine and general internal medicine practices , primarily fee-for-service , half group practices and half solo practitioners .
METHODS	Physician investigators and facilitators met with practice physicians and staff over a period of 12 to 18 months to provide feedback on breast cancer screening performance , and to assist these primary care practices in developing office systems tailored to increase breast cancer screening .
RESULTS	Physician questionnaires were obtained at baseline and follow-up to assess the presence of five indicators of an office system .
RESULTS	Three of the five indicators of office systems increased significantly more in intervention practices than in control practices , but the mean number of indicators in intervention practices at followup was only 2.8 out of 5 .
RESULTS	Cross-sectional reviews of randomly chosen medical records of eligible women patients aged 50 years and over were done at baseline ( n = 2,887 ) and follow-up ( n = 2,874 ) to determine whether clinical breast examinations and mammography , were performed .
RESULTS	Results for mammography were recorded in two ways , mention of the test in the visit note and actual report of the test in the medical record .
RESULTS	These reviews showed an increase from 39 % to 51 % in mention of mammography in intervention practices , compared with an increase from 41 % to 44 % in control practices ( p = .01 ) .
RESULTS	There was no significant difference , however , between the two groups in change in mammograms reported ( intervention group increased from 28 % to 32.7 % ; control group increased from 30.6 % to 34.0 % , p = .56 ) .
RESULTS	There was a nonsignificant trend ( p = .06 ) toward a greater increase in performance of clinical breast examination in intervention versus control practices .
CONCLUSIONS	A moderately intensive outreach intervention to increase rates of breast cancer screening through the development of office systems was modestly successful in increasing indicators of office systems and in documenting mention of mammography , but had little impact on actual performance of breast cancer screening .
CONCLUSIONS	At follow-up , few practices had a complete office system for breast cancer screening .
CONCLUSIONS	Outreach approaches to assist primary care practices implement office systems are promising but need further development .

###20855554
BACKGROUND	Chronic proximal hamstring tendinopathy is an overuse syndrome that is usually managed by nonoperative methods .
BACKGROUND	Shockwave therapy has proved to be effective in many tendinopathies .
OBJECTIVE	Shockwave therapy may be more effective than other nonoperative treatments for chronic proximal hamstring tendinopathy .
METHODS	Randomized controlled clinical study ; Level of evidence , 1 .
METHODS	Forty professional athletes with chronic proximal hamstring tendinopathy were enrolled between February 1 , 2004 , and September 30 , 2006 .
METHODS	Patients were randomly assigned to receive either shockwave therapy , consisting of 2500 impulses per session at a 0.18 mJ/mm energy flux density without anesthesia , for 4 weeks ( SWT group , n = 20 ) , or traditional conservative treatment consisting of nonsteroidal anti-inflammatory drugs , physiotherapy , and an exercise program for hamstring muscles ( TCT group , n = 20 ) .
METHODS	Patients were evaluated before treatment , and 1 week and 3 , 6 , and 12 months after the end of treatment .
METHODS	The visual analog scale ( VAS ) score for pain and Nirschl phase rating scale ( NPRS ) were used as primary outcome measures .
RESULTS	The patients were observed for a mean of 10.7 months ( range , 1-12 months ) .
RESULTS	Six patients were lost to follow-up because they underwent a surgical intervention : 3 ( all in TCT group ) were lost at 3 months ; 2 ( 1 in each group ) , at 6 months ; and 1 ( in the TCT group ) , at 12 months .
RESULTS	Primary follow-up was at 3 months after the beginning of treatment .
RESULTS	The VAS scores in the SWT and TCT groups were 7 points before treatment ( P = .84 ) , and 2 points and 5 points , respectively , 3 months after treatment ( P < .001 ) .
RESULTS	The NPRS scores in the SWT and TCT groups were 5 points in either group before treatment ( P = .48 ) , and 2 points and 6 points , respectively , 3 months after treatment ( P < .001 ) .
RESULTS	At 3 months after treatment , 17 of the 20 patients ( 85 % ) in the SWT group and 2 of the 20 patients ( 10 % ) in the TCT group achieved a reduction of at least 50 % in pain ( P < .001 ) .
RESULTS	There were no serious complications in the SWT group .
CONCLUSIONS	Shockwave therapy is a safe and effective treatment for patients with chronic proximal hamstring tendinopathy .

###24019080
OBJECTIVE	Postsurgical recurrence of Crohn 's disease ( CD ) is very frequent and , to date , only infliximab has been shown to be useful in preventing it .
OBJECTIVE	The efficacy of adalimumab ( ADA ) is poorly known .
OBJECTIVE	We evaluated whether the administration of ADA after resective intestinal surgery reduces postoperative CD recurrence .
METHODS	We randomly assigned 51 patients with CD who had undergone ileocolonic resection to receive after 2 weeks from surgery ADA at the dose of 160/80/40mg every two weeks , azathioprine ( AZA ) at 2mg/kg/day , or mesalamine at 3g/day , and they were followed up for 2 years .
METHODS	The primary end point was the proportion of patients with endoscopic and clinical recurrence .
METHODS	Secondary end point was the assessment of quality of life by means of a previously validated questionnaire .
RESULTS	The rate of endoscopic recurrence was significantly lower in ADA ( 6.3 % ) compared with the AZA ( 64.7 % ; odds ratio ( OR ) = 0.036 ( 95 % confidence interval ( CI ) 0.004-0 .347 ) ) and mesalamine groups ( 83.3 % ; OR = 0.013 ( 95 % CI 0.001-0 .143 ) ) .
RESULTS	There was a significantly lower proportion of patients in clinical recurrence in the ADA group ( 12.5 % ) compared with the AZA ( 64.7 % ; OR = 0.078 ( 95 % CI 0.013-0 .464 ) ) and mesalamine groups ( 50 % ; ( OR = 0.143 ( 95 % CI 0.025-0 .819 ) ) .
RESULTS	The quality of life was higher in the ADA ( 202 ) than in the AZA ( 90 ; OR = 0.028 ( 95 % CI 0.004-0 .196 ) ) and mesalamine groups ( 98 ; OR = 0.015 ( 95 % CI 0.002-0 .134 ) ) .
CONCLUSIONS	The administration of ADA after intestinal resective surgery was greatly effective in preventing endoscopic and clinical recurrence of CD .
CONCLUSIONS	Further larger studies are necessary to confirm the therapeutic advantage and to show the economic implications of biologic therapy in this field .

###15628774
OBJECTIVE	There is some evidence for the efficacy of acupuncture in chronic low back pain , but it remains unclear which acupuncture modes are most effective .
OBJECTIVE	Our objective was to evaluate the effects of two different modes of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared to standard acupuncture treatment .
METHODS	Thirty five consecutive out-patients ( 25 women , 10 men ; age range : 65-81 years ) from the Department of Orthopaedic Surgery , Meiji University of Oriental Medicine , with non-radiating low back pain for at least six months and normal neurological examination , were randomised to one of three groups over 12 weeks .
METHODS	Each group received two phases of acupuncture treatment with an interval between them .
METHODS	Nine patients dropped out during the course of the study .
METHODS	The standard acupuncture group ( n = 9 ) received treatment at traditional acupuncture points for low back pain , while the other acupuncture groups received superficial ( n = 9 ) or deep ( n = 9 ) treatments on trigger points .
METHODS	Outcome measures were VAS pain intensity and Roland Morris Questionnaire .
RESULTS	After treatment , the group that received deep needling to trigger points reported less pain intensity and improved quality of life compared to the standard acupuncture group or the group that received superficial needling to trigger points , but the differences were not statistically significant .
RESULTS	There was a significant reduction in pain intensity between the treatment and interval in the group that received deep needling to trigger points ( P < 0.01 ) , but not in the standard acupuncture group or the group that received superficial needling to trigger points .
CONCLUSIONS	These results suggest that deep needling to trigger points may be more effective in the treatment of low back pain in elderly patients than either standard acupuncture therapy , or superficial needling to trigger points .

###16157899
BACKGROUND	Xenografts from patients with Charcot-Marie-Tooth type 1A ( CMT1A ) have shown delayed myelination and impaired regeneration of nude mice axons passing through the grafted segments .
BACKGROUND	Neurotrophin-3 ( NT-3 ) , an important component of the Schwann cell ( SC ) autocrine survival loop , could correct these deficiencies .
OBJECTIVE	To assess the efficacy of NT-3 treatment in preclinical studies using animal models of CMT1A and to conduct a double-blind , placebo-controlled , randomized , pilot clinical study to assess the efficacy of subcutaneously administered NT-3 in patients with CMT1A .
METHODS	Nude mice harboring CMT1A xenografts and Trembler ( J ) mice with a peripheral myelin protein 22-point mutation were treated with NT-3 , and the myelinated fiber ( MF ) and SC numbers were quantitated .
METHODS	Eight patients received either placebo ( n = 4 ) or 150 microg/kg NT-3 ( n = 4 ) three times a week for 6 months .
METHODS	MF regeneration in sural nerve biopsies before and after treatment served as the primary outcome measure .
METHODS	Additional endpoint measures included the Mayo Clinic Neuropathy Impairment Score ( NIS ) , electrophysiologic measurements , quantitative muscle testing , and pegboard performance .
RESULTS	The NT-3 treatment augmented axonal regeneration in both animal models .
RESULTS	For CMT1A patients , changes in the NT-3 group were different from those observed in the placebo group for the mean number of small MFs within regeneration units ( p = 0.0001 ) , solitary MFs , ( p = 0.0002 ) , and NIS ( p = 0.0041 ) .
RESULTS	Significant improvements in these variables were detected in the NT-3 group but not in the placebo group .
RESULTS	Pegboard performance was significantly worsened in the placebo group .
RESULTS	NT-3 was well tolerated .
CONCLUSIONS	Neurotrophin-3 augments nerve regeneration in animal models for CMT1A and may benefit patients clinically , but these results need further confirmation .

###24292111
BACKGROUND	Sentinel lymph node biopsy alone has become an acceptable alternative to elective axillary lymph node dissection in patients with clinically node-negative early-stage breast cancer .
BACKGROUND	Approximately 70 percent of the patients undergoing breast surgery develop side effects caused by the axillary lymph node dissection ( axillary pain , shoulder stiffness , lymphedema and paresthesias ) .
OBJECTIVE	The current standard treatment is to perform completion axillary lymph node dissection in patients with positive sentinel lymph node biopsy .
OBJECTIVE	However , randomized clinical trials of axillary dissection versus axillary irradiation failed to show survival differences between the two types of axillary treatment .
OBJECTIVE	The National Institute of Oncology , Budapest conducted a single centre randomized clinical study .
OBJECTIVE	The OTOASOR ( Optimal Treatment of the Axilla - Surgery or Radiotherapy ) trial compares completion axillary lymph node dissection to axillary nodal irradiation in patients with sentinel lymph node-positive primary invasive breast cancer .
METHODS	Patients with primary invasive breast cancer ( clinically lymph node negative and less than or equal to 3 cm in size ) were randomized before surgery for completion axillary lymph node dissection ( arm A-standard treatment ) or axillary nodal irradiation ( arm B-investigational treatment ) .
METHODS	Sentinel lymph node biopsy was performed by the radio-guided method .
METHODS	The use of blue-dye was optional .
METHODS	Sentinel lymph nodes were investigated with serial sectioning at 0.5 mm levels by haematoxylin and eosin staining .
METHODS	In the investigational treatment arm patients received 50Gy axillary nodal irradiation instead of completion axillary lymph node dissection .
METHODS	Adjuvant treatment was recommended and patients were followed up according to the actual institutional guidelines .
RESULTS	Between August 2002 and June 2009 , 2106 patients were randomized for completion axillary lymph node dissection ( 1054 patients ) or axillary nodal irradiation ( 1052 patients ) .
RESULTS	The two arms were well balanced according to the majority of main prognostic factors .
RESULTS	Sentinel lymph node was identified in 2073 patients ( 98.4 % ) and was positive in 526 patients ( 25.4 % ) .
RESULTS	Fifty-two sentinel lymph node-positive patients were excluded from the study ( protocol violation , patient 's preference ) .
RESULTS	Out of the remaining 474 patients , 244 underwent completion axillary lymph node dissection and 230 received axillary nodal irradiation according to randomization .
RESULTS	The mean length of follow-up to the first event and the mean total length of follow-up were 41.9 and 43.3 months , respectively , and there were no significant differences between the two arms .
RESULTS	There was no significant difference in axillary recurrence between the two arms ( 0.82 % in arm A and 1.3 % in arm B ) .
RESULTS	There was also no significant difference in terms of overall survival between the arms at the early stage follow-up .
CONCLUSIONS	The authors conclude that after a mean follow-up of more than 40 months axillary nodal irradiation may control the disease in the axilla as effectively as completion axillary lymph node dissection and there was also no difference in terms of overall survival .

###18227359
BACKGROUND	Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits .
METHODS	We conducted a randomized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater .
METHODS	In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program .
METHODS	Goals were then reviewed at each clinic visit by physicians .
METHODS	The control group received only printed health education materials .
METHODS	The main outcome measures included change in physical activity and body weight .
RESULTS	In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P = .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P = .006 ) .
CONCLUSIONS	A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss .

###18231720
BACKGROUND	Aspiration pneumonia ( AP ) and primary lung abscess ( PLA ) , are diseases following aspiration of infectious material from the oropharynx or stomach .
BACKGROUND	An antibiotic therapy , also covering anaerobic pathogens , is the treatment of choice .
BACKGROUND	In this study we compared moxifloxacin ( MXF ) and ampicillin/sulbactam ( AMP/SUL ) concerning efficacy and safety in the treatment of AP and PLA .
METHODS	Patients with pulmonary infections following aspiration were included in a prospective , open-label , randomized , multicenter trial .
METHODS	Sequential antibiotic therapy with MXF or AMP/SUL was administered until complete radiologic and clinical resolution .
RESULTS	A total of 139 patients with AP and PLA were included , 96 were evaluable for efficacy ( EE , 48 patients in each treatment group ) .
RESULTS	The overall clinical response rates in both groups were numerically identical ( 66.7 % ) .
RESULTS	MXF and AMP/SUL were both well tolerated , even after long-term administration [ median duration of treatment ( range ) in days MXF versus AMP/SUL : AP 11 ( 4-45 ) vs 9 ( 3-25 ) , PLA 30.5 ( 7-158 ) vs 35 ( 6-90 ) ] .
CONCLUSIONS	In the treatment of aspiration-associated pulmonary infections moxifloxacin appears to be clinically as effective and as safe as ampicillin/sulbactam ; but , however , having the additional benefit of a more convenient ( 400 mg qd ) treatment .

###22451180
OBJECTIVE	to compare the effectiveness of metformin and pioglitazone in ameliorating insulin resistance and cardiovascular risk factors in women with polycystic ovary syndrome ( PCOS ) .
METHODS	this study was a randomized clinical trial to compare treatment with metformin and pioglitozone .
METHODS	Fifty two women with PCOS aged 20-45 years were randomly allocated to one of the two treatment groups .
METHODS	All patients underwent clinical and biochemical evaluation and analyses involving these measures which consisted of repeated measures MANOVA using the pre - and post-intervention fasting blood sugar ( FBS ) , lipid profiles , body mass index ( BMI ) , serum insulin in two groups .
RESULTS	weight and BMI were significantly decreased in metformin group but not in case of pioglitazone .
RESULTS	FBS , serum triglycerides , total cholesterol were all reduced significantly by both metfomin and pioglitazone .
RESULTS	Insulin resistance measured by homeostasis model assessment ( HOMA ) method was significantly decreased in both treatment groups ( P < 0.05 ) .
RESULTS	There were no significant differences between treatments in most of variables except BMI .
CONCLUSIONS	these results suggest pioglitazone is as effective as metformin in improving insulin sensitivity and some cardiovascular risk biomarkers but it has no significant effect on reducing BMI and body weight .

###23351825
BACKGROUND	Systolic blood pressure ( SBP ) is related to the pathophysiologic development and progression of heart failure ( HF ) and is inversely associated with adverse outcomes during hospitalization for HF ( HHF ) .
BACKGROUND	The prognostic value of SBP after initiating inhospital therapy and the mode of death and etiology of cardiovascular readmissions based on SBP have not been well characterized in HHF .
METHODS	A post hoc analysis was performed of the placebo group ( n = 2061 ) of the EVEREST trial , which enrolled patients within 48 hours of admission for worsening HF with an ejection fraction ( EF ) 40 % and an SBP 90 mm Hg , for a median follow-up of 9.9 months .
METHODS	Systolic blood pressure was measured at baseline , daily during hospitalization , and at discharge/day 7 .
METHODS	Patients were divided into the following quartiles by SBP at baseline : 105 , 106 to 119 , 120 to 130 , and 131 mm Hg .
METHODS	Outcomes were all-cause mortality ( ACM ) and the composite of cardiovascular mortality or HHF ( CVM + HHF ) .
METHODS	The associations between baseline , discharge , and inhospital change in SBP and ACM and CVM + HHF were assessed using multivariable Cox proportional hazards regression models adjusted for known covariates .
RESULTS	Median ( 25th , 75th ) SBP at baseline was 120 ( 105 , 130 ) mm Hg and ranged from 82 to 202 mm Hg .
RESULTS	Patients with a lower SBP were younger and more likely to be male ; had a higher prevalence of prior revascularization and ventricular arrhythmias ; had a lower EF , worse renal function , higher natriuretic peptide concentrations , and wider QRS durations ; and were more likely to require intravenous inotropes during hospitalization .
RESULTS	Lower SBP was associated with increased mortality , driven by HF and sudden cardiac death , and cardiovascular hospitalization , primarily caused by HHF .
RESULTS	After adjusting for potential confounders , SBP was inversely associated with risk of the coprimary end points both at baseline ( ACM : hazard ratio [ HR ] / 10-mm Hg decrease 1.15 , 95 % CI1.08-1 .22 ; CVM + HHF : HR 1.09 / 10-mm Hg decrease , 95 % CI 1.04-1 .14 ) and at the time of discharge/day 7 ( ACM : HR 1.15 / 10-mm Hg decrease , 95 % CI 1.08-1 .22 ; CVM + HHF : HR 1.07 / 10-mm Hg decrease , 95 % CI 1.02-1 .13 ) , but the association with inhospital SBP change was not significant .
CONCLUSIONS	Systolic blood pressure is an independent clinical predictor of morbidity and mortality after initial therapy during HHF with reduced EF .

###21962336
BACKGROUND	Developing a sense of well-being and achieving maternal role competence are considered critical components of maternal adaptation .
BACKGROUND	Given the growing evidence of postpartum depression and its devastating effects , effective childbirth psychoeducation programme to promote maternal role competence , psychological well-being and prevent postpartum depression is essential and of an urgent priority .
OBJECTIVE	To examine the effects of an interpersonal psychotherapy oriented childbirth education programme on social support , maternal role competence , postpartum depression and psychological well-being in Chinese first-time childbearing women at three-month postpartum .
METHODS	Randomised controlled trial in a regional teaching hospital , Guangzhou , China with 194 first-time pregnant women , of whom 96 received interpersonal-psychotherapy-oriented childbirth education programme and 98 standard care .
METHODS	The intervention was developed from principles of interpersonal psychotherapy which consisted of two 90-min antenatal classes and a telephone follow-up within two weeks after delivery .
METHODS	Outcomes measurements included Perceived Social Support Scale , Parenting Sense of Competence Scale-Efficacy subscale , Edinburgh Postnatal Depression Scale and General Health Questionnaire , were compared over three-month follow up .
RESULTS	The study group had significantly better improvement on perceived social support ( p < 0.01 ) , maternal role competence ( p < 0.01 ) , postpartum depressive symptoms ( p < 0.01 ) and psychological well-being ( p < 0.01 ) when compared with the control group .
RESULTS	The study group also had significantly higher level of social support ( t = 2.33 , p = 0.021 ) , maternal role competence ( t = 2.43 , p = 0.016 ) and less depressive symptoms ( t = -2.39 , p = 0.018 ) at three-month postpartum when compared with the control group .
CONCLUSIONS	The childbirth psychoeducation programme can substantially benefit first time Chinese mothers .
CONCLUSIONS	It could be implemented as a routine care with ongoing evaluation .
CONCLUSIONS	Future studies could focus on women in lower social classes , with multiple pregnancy and complicated pregnancy .

###22464260
OBJECTIVE	The purpose of this study was to characterize patients with mitral regurgitation ( MR ) and atrial fibrillation ( AF ) treated percutaneously using the MitraClip device ( Abbott Vascular , Abbott Park , Illinois ) and compare the results with surgery in this population .
BACKGROUND	The EVEREST II ( Endovascular Valve Edge-to-Edge Repair Study ) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery , providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair .
METHODS	The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory .
METHODS	Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol ( cohort of patients with MR 2 + at discharge ) analyses .
RESULTS	Pre-existing AF was present in 27 % of patients .
RESULTS	These patients were older , had more advanced disease , and were more likely to have a functional etiology .
RESULTS	Similar reduction of MR to 2 + before discharge was achieved in patients with AF ( 83 % ) and in patients without AF ( 75 % , p = 0.3 ) .
RESULTS	Freedom from death , mitral valve surgery for valve dysfunction , and MR > 2 + was similar at 12 months for AF patients ( 64 % ) and for no-AF patients ( 61 % , p = 0.3 ) .
RESULTS	At 12 months , MR reduction to < 2 + was greater with surgery than with MitraClip , but there was no interaction between rhythm and MR reduction , and no difference in all-cause mortality between patients with and patients without AF .
CONCLUSIONS	Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities .
CONCLUSIONS	However , acute procedural success , safety , and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF .

###19196482
BACKGROUND	Skin cancer is the most prevalent yet most preventable cancer in the US .
BACKGROUND	While protecting oneself from ultraviolet radiation ( UVR ) can largely reduce risk , rates of unprotected sun exposure remain high .
BACKGROUND	Because the desire to be tan often outweighs health concerns among sunbathers , very few interventions have been successful at reducing sunbathing behavior .
BACKGROUND	Sunless tanning ( self-tanners and spray tans ) , a method of achieving the suntanned look without UVR exposure , might be an effective supplement to prevention interventions .
METHODS	This cluster randomized trial will examine whether a beach-based intervention that promotes sunless tanning as a substitute for sunbathing and includes sun damage imaging and sun safety recommendations is superior to a questionnaire only control group in reducing sunbathing frequency .
METHODS	Female beach visitors ( N = 250 ) will be recruited from 2 public beaches in eastern Massachusetts .
METHODS	Beach site will be the unit of randomization .
METHODS	Follow-up assessment will occur at the end of the summer ( 1-month following intervention ) and 1 year later .
METHODS	The primary outcome is average sunbathing time per week .
METHODS	The study was designed to provide 90 % power for detecting a difference of .70 hours between conditions ( standard deviation of 2.0 ) at 1-year with an intra-cluster correlation coefficient of 0.01 and assuming a 25 % rate of loss to follow-up .
METHODS	Secondary outcomes include frequency of sunburns , use of sunless tanning products , and sun protection behavior .
CONCLUSIONS	Interventions might be improved by promoting behavioral substitutes for sun exposure , such as sunless tanners , that create a tanned look without exposure to UVR .
BACKGROUND	NCT00403377 .

###24170814
BACKGROUND	Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent ( ESA ) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease ( ND-CKD ) .
METHODS	FIND-CKD was a 56-week , open-label , multicentre , prospective , randomized three-arm study ( NCT00994318 ) of 626 patients with ND-CKD and iron deficiency anaemia randomized to ( i ) intravenous ( IV ) ferric carboxymaltose ( FCM ) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 g/L ( ii ) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 g/L or ( iii ) oral ferrous sulphate 200 mg iron/day .
METHODS	The primary end point was time to initiation of other anaemia management ( ESA therapy , iron therapy other than study drug or blood transfusion ) or a haemoglobin ( Hb ) trigger ( two consecutive Hb values < 10 g/dL without an increase of 0.5 g/dL ) .
RESULTS	The background , rationale and study design of the trial are presented here .
RESULTS	The study has been completed and results are expected in late 2013 .
CONCLUSIONS	FIND-CKD was the longest randomized trial of IV iron therapy to date .
CONCLUSIONS	Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD .
CONCLUSIONS	It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing , and the first not to employ Hb response as its primary end point .

###24993838
BACKGROUND	Despite the findings of several randomized clinical studies , the role of gentamicin collagen implant ( GCI ) in rectal cancer surgery is unclear .
BACKGROUND	Local pelvic application of GCI following preoperative radiotherapy and total mesorectal excision ( TME ) was evaluated to determine the risk of surgical site infections ( SSI ) .
METHODS	In this single-center trial , 176 patients with rectal cancer after preoperative , short-term radiotherapy ( 5 5 Gy ) were randomized either to the study group in which GCI was used or in the control group without GCI .
METHODS	Prior to surgery and intraoperatively five patients were excluded from the study .
METHODS	The remaining 171 patients were analyzed ; 86 were in the study group and 85 in the control group .
RESULTS	There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group : 25.6 and 34.1 % respectively ; p = 0.245 , relative risk ( RR ) 0.750 [ 95 % confidence interval ( CI ) 0.471-1 .195 ] .
RESULTS	The reoperation rate was similar in both groups : 12.8 versus 9.4 % ; p = 0.628 ; RR 1.359 ; ( 95 % CI 0.575-3 .212 ) .
RESULTS	The total rate of SSI and organ space SSI were 22.2 and 15.8 % without differences between the study and control group .
RESULTS	In patients without anastomotic leakage , the risk of organ space SSI was significantly reduced in patients who received GCI : 2.6 versus 13.0 % ; p = 0.018 .
CONCLUSIONS	Application of GCI in the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage .

###8007079
OBJECTIVE	To determine whether individuals selected for good general health , high hypnotizability , and the ability to alter skin temperature under hypnotic suggestion can influence the delayed-type hypersensitivity ( DTH ) response to varicella-zoster ( VZ ) antigen under hypnotic suggestion .
METHODS	A blinded clinical trial using a repeated measures design with subjects serving as their own controls .
METHODS	Subjects were randomly assigned to undergo a predetermined sequence of four different experimental conditions , occurring at weekly intervals , with each condition including VZ skin testing : ( 1 ) hypnosis with suggestions to enhance the DTH response to VZ antigen ; ( 2 ) hypnosis with suggestions to suppress the DTH response ; ( 3 ) hypnosis with suggestions for relaxation only ; and ( 4 ) skin testing without hypnosis .
METHODS	A National Institutes of Health-supported clinical research center in a teaching hospital .
METHODS	A stratified sample of 24 ambulatory , healthy , highly hypnotizable , volunteer college students selected for their above-average ability to alter skin temperature after hypnotic suggestions and their positive baseline responses to VZ antigen .
METHODS	There were 11 males and 13 females with a mean + / - SD age of 22 + / - 6 years .
METHODS	The mean + / - SD hypnotizability score ( Harvard Group Scale of Hypnotic Susceptibility ) was 11 + / - 1 .
METHODS	Intradermal skin testing with VZ antigen ( Mantoux method ) and hypnotic suggestion .
METHODS	Areas of induration of the DTH response measured at 24 and 48 hours after injection of antigen .
RESULTS	The area of the DTH response was not affected by the experimental interventions .
RESULTS	The area of erythema was likewise unaffected .
CONCLUSIONS	Our subjects were unable to alter their DTH responses using hypnotic suggestion .

###19049375
OBJECTIVE	This study was designed to assess diabetes-related distress and its association with clinical outcomes in patients with type 2 diabetes using basal insulin who were treated with pramlintide .
METHODS	In a 16-week , double-blind , placebo-controlled study 211 patients using insulin glargine with or without oral antidiabetes agents were randomized to addition of pramlintide or placebo .
METHODS	Clinical outcomes ( change in A1C , postprandial glucose , daily basal insulin dose , and weight ) and during-trial hypoglycemia were assessed , along with the Diabetes Distress Scale ( DDS ) .
METHODS	The DDS assesses overall diabetes distress and four subdomains : regimen distress ( RD ) , emotional burden ( EB ) , interpersonal distress ( ID ) , and physician-related distress ( PD ) .
METHODS	Hierarchical , stepwise multiple regression was used to assess the association of clinical outcomes and during-trial hypoglycemia with DDS score changes during the study .
RESULTS	Pramlintide use was associated with a significant reduction in total DDS and RD , but only among those above the median of distress at baseline .
RESULTS	Across treatment groups , reduction in basal insulin dose was linked to a drop in total DDS , RD , EB , and ID , reduction in postprandial glucose was associated with reduced total DDS and ID , and reduction in A1C was associated with reduced EB and RD. .
RESULTS	PD was not associated with hypoglycemia or any clinical outcome .
RESULTS	Reduction in weight and incidence of hypoglycemia were not associated with any DDS measure .
CONCLUSIONS	Pramlintide use reduced diabetes-related distress among those with high levels of distress at baseline , and better clinical outcomes were associated with improvements in several domains of diabetes-related distress .
CONCLUSIONS	Efforts should be made to enhance these potential benefits of treatment .

###21122851
OBJECTIVE	Endothelial progenitor cells ( EPCs ) contribute to the maintenance of endothelial integrity and function .
OBJECTIVE	We investigated the effects of rosuvastatin and allopurinol on the number of EPCs in patients with heart failure and aimed to provide insight into the molecular inflammatory and oxidative mechanisms that could be responsible for the alterations in EPC levels after treatment .
METHODS	Sixty patients with systolic heart failure were randomized to receive rosuvastatin 10mg/d , allopurinol 300mg/d or placebo and followed up for 1 month .
METHODS	The number of CD34 ( + ) / KDR ( + ) and CD34 ( + ) / CD133 ( + ) / KDR ( + ) EPCs in blood was evaluated by flow cytometry .
METHODS	Endothelial function was assessed by brachial artery flow-mediated dilation .
METHODS	Levels of markers of inflammation and oxidative stress were also determined .
RESULTS	Circulating EPCs were significantly increased after rosuvastatin treatment ( from 230 ( 170-380 ) and 10 ( 8-24 ) to 390 ( 230-520 ) and 19 ( 8-33 ) cells/10 ( 6 ) lymphomonocytes , respectively , p = 0.004 and p = 0.008 ) , whereas they remained unchanged in the other groups .
RESULTS	The increase in EPC levels was not associated with the changes in the levels of the measured inflammatory and oxidative markers .
CONCLUSIONS	Short-term treatment with rosuvastatin , but not allopurinol , significantly increases the number of circulating EPCs in patients with heart failure providing further insights into its role in these individuals .
CONCLUSIONS	The impact of rosuvastatin on EPCs is not mediated by changes in inflammatory and oxidative status .

###21930328
BACKGROUND	Ustekinumab targets interleukin ( IL ) -12 and IL-23 in the treatment of moderate-to-severe psoriasis .
OBJECTIVE	To evaluate overall pooled study data to assess the safety profile of ustekinumab through 3 years of treatment .
METHODS	Cumulative safety data were pooled from studies in 3117 ustekinumab-treated patients .
RESULTS	During the placebo-controlled periods ( Phase 2 , PHOENIX 1 , PHOENIX 2 ) , rates of adverse events ( AEs ) were comparable among patients treated with placebo ( 50.4 % ) , with ustekinumab 45 mg ( 57.6 % ) , or with ustekinumab 90 mg ( 51.6 % ) ; similar findings were observed during the controlled period of the ACCEPT trial ( etanercept : 70.0 % ; ustekinumab 45 mg : 66.0 % ; and ustekinumab 90 mg : 69.2 % ) .
RESULTS	Rates of serious AEs ( SAEs ) through the controlled periods were low and comparable among all groups ( 1.2 % to 1.9 % ) .
RESULTS	Through 3 years , rates of AEs per 100 patient-years of follow-up ( / 100 patient-yrs ) ( 45 mg : 305.2 / 100 patient-yrs ; 90 mg : 305.9 / 100 patient-yrs ) and SAEs ( 45 mg : 6.8 / 100 patient-yrs ; 90 mg : 8.2 / 100 patient-yrs ) were comparable between ustekinumab doses .
RESULTS	No cases of demyelination or tuberculosis were reported in these trials .
RESULTS	No dose response in rates of AEs , overall infections , or SAEs was apparent through 3 years .
RESULTS	Rates of AEs , infections , SAEs , and AEs leading to study agent discontinuation remained generally stable or decreased over time .
CONCLUSIONS	Controlled periods did not extend beyond 12 to 20 weeks .
CONCLUSIONS	Only 1247 of the 3117 ustekinumab-treated patients were treated for 2 or more years .
CONCLUSIONS	The safety profile of continued ustekinumab exposure through up to 3 years is favorable and consistent with previous short-term reports .

###10583039
OBJECTIVE	This serendipitous study revealed an unexpected effect of Jufeng grape juice on the CYP1A2-mediated metabolism of phenacetin .
OBJECTIVE	Investigation of the inhibition of CYP1A2 by grapefruit juice was involved but a translation error led to the grape juice substitution .
METHODS	Twelve healthy subjects took a single oral dose of phenacetin ( 900 mg ) on two randomized occasions together with 200 ml water or grape juice .
METHODS	Plasma phenacetin and paracetamol concentrations were assessed by h.p.l.c.
RESULTS	Ingestion of grape juice was associated with reduced plasma phenacetin concentrations , while paracetamol levels were unaffected .
RESULTS	Paracetamol to phenacetin AUC ratios increased from 13.9 + / -3.1 to 24.3 + / -3.8 after ingestion of grape juice .
CONCLUSIONS	These findings suggest enhanced first-pass metabolism of phenacetin , due to CYP1A2 activation by grape juice or to desaturation of CYP1A2 isoenzymes secondary to a slower rate of phenacetin absorption .

###18422809
BACKGROUND	General iron supplementation to prevent iron deficiency in infants who are iron sufficient when starting supplementation may adversely affect their health .
OBJECTIVE	A secondary analysis to explore the effect of iron supplementation on iron-replete ( IR ; Hb > or = 113 g/L and S-ferritin > or = 33 microg/L ) or non-iron-replete 6-month-old Indonesian infants participating in a large , randomized trial on iron and zinc supplementation .
RESULTS	Among the iron-supplemented IR ( Fe-IR , n = 80 ) infants S-ferritin was , compared to non-iron-supplemented ( NS ) IR infants ( NS-IR , n = 74 ) , significantly higher ( 47.5 vs. 20.7 microg/L , p = 0.04 ) , and S-zinc significantly lower ( 9.7 vs. 10.5 micromol/L , p = 0.04 ) .
RESULTS	Haemoglobin concentration ( Hb ) did not differ between the Fe-IR and NS-IR groups .
RESULTS	Change in weight-for-age z-score ( WAZ ) from 6 to 12 months and mean WAZ at 12 months was lower in the Fe-IR group compared to the NS-IR group ( -1.45 vs. -1.03 , p < 0.001 and -1.97 vs. -1.60 , p < 0.001 , respectively ) .
RESULTS	There was no difference in morbidity between groups .
RESULTS	Iron supplementation of non-iron-replete infants increased Hb and S-ferritin , but did not affect S-zinc or anthropometrical indices .
CONCLUSIONS	In our study , iron supplementation of IR infants affected WAZ adversely , whereas iron supplementation to non-iron-replete infants did not affect growth .
CONCLUSIONS	These results support a cautious approach to iron supplementation of IR infants .

###15084616
OBJECTIVE	To determine whether addition of the farnesyltransferase inhibitor tipifarnib ( Zarnestra , R115777 ; Johnson and Johnson Pharmaceutical Research and Development , Beerse , Belgium ) to standard gemcitabine therapy improves overall survival in advanced pancreatic cancer .
METHODS	This randomized , double-blind , placebo-controlled study compared gemcitabine + tipifarnib versus gemcitabine + placebo in patients with advanced pancreatic adenocarcinoma previously untreated with systemic therapy .
METHODS	Tipifarnib was given at 200 mg bid orally continuously ; gemcitabine was given at 1,000 mg/m ( 2 ) intravenously weekly x 7 for 8 weeks , then weekly x 3 every 4 weeks .
METHODS	The primary end point was overall survival ; secondary end points included 6-month and 1-year survival rates , progression-free survival , response rate , safety , and quality of life .
RESULTS	Six hundred eighty-eight patients were enrolled .
RESULTS	Baseline characteristics were well balanced between the two treatment arms .
RESULTS	No statistically significant differences in survival parameters were observed .
RESULTS	The median overall survival for the experimental arm was 193 v 182 days for the control arm ( P = .75 ) ; 6-month and 1-year survival rates were 53 % and 27 % v 49 % and 24 % for the control arm , respectively ; median progression-free survival was 112 v 109 days for the control arm .
RESULTS	Ten drug-related deaths were reported for the experimental arm and seven for the control arm .
RESULTS	Neutropenia and thrombocytopenia grade > or = 3 were observed in 40 % and 15 % in the experimental arm versus 30 % and 12 % in the control arm .
RESULTS	Incidences of nonhematologic adverse events were similar in two groups .
CONCLUSIONS	The combination of gemcitabine and tipifarnib has an acceptable toxicity profile but does not prolong overall survival in advanced pancreatic cancer compared with single-agent gemcitabine .

###9374560
OBJECTIVE	To evaluate the efficacy of high titer respiratory syncytial virus ( RSV ) immune globulin ( RSVIG ) in the treatment of previously healthy children hospitalized with proven RSV lower tract infection ( LRI ) .
METHODS	Infants and young children < / = 2 years of age with RSV LRI of < / = 4 days duration , and respiratory scores > / = 2.5 were enrolled .
RESULTS	One hundred and one previously healthy children hospitalized with RSV LRI received either 1500 mg/kg of RSVIG ( RespiGam , MedImmune Inc , Gaithersburg , MD ) or albumin placebo in a randomized , double-blind , placebo-controlled trial .
RESULTS	Forty-six RSVIG and 52 recipients of placebo met all eligibility criteria .
RESULTS	Demographic characteristics of the two groups were similar .
RESULTS	More RSVIG recipients ( 46 % vs 29 % ) had an SaO2 < / = 85 % at entry than did placebo recipients , but a higher proportion of placebo recipients required intensive care unit ( ICU ) care and mechanical ventilation at study entry .
RESULTS	The mean RSV hospital stay was 5.52 + / - 0.69 days ( SE ) for placebo and 4.58 + / - 0.40 days for RSVIG .
RESULTS	Additionally , there was an interaction between treatment group and entry respiratory score , which led to subgroup analysis .
RESULTS	Children with modest respiratory illness did not receive any benefit from RSVIG therapy .
RESULTS	RSVIG recipients with more severe illness ( entry respiratory scores > / = 3.0 ) had 1.6 fewer hospital days and 2.7 days less ICU stays .
CONCLUSIONS	RSVIG infusions seemed safe and generally well tolerated .
CONCLUSIONS	Although some beneficial effect trends were seen for those with more severe disease who were treated there was no evidence that treatment with RSVIG resulted in reduced hospitalization and reduced ICU stays in all children with RSV disease .

###14739817
BACKGROUND	In this randomized , double-blind study , the authors investigated the efficacy of continuous and patient-controlled ropivacaine infusions via an infraclavicular perineural catheter in ambulatory patients undergoing moderately painful orthopedic surgery at or distal to the elbow .
METHODS	Preoperatively , patients ( n = 30 ) received an infraclavicular perineural catheter and nerve block .
METHODS	Postoperatively , patients were discharged home with both oral analgesics and a portable infusion pump delivering 0.2 % ropivacaine ( 500-ml reservoir ) in one of three dosing regimens : the basal group ( 12 ml/h basal , 0.05-ml patient-controlled bolus dose ) , the basal-bolus group ( 8 ml/h basal , 4 ml bolus ) , or the bolus group ( 0.3 ml/h basal , 9.9 ml bolus ) .
METHODS	Investigators and patients were blinded to random group assignment .
RESULTS	The basal group ( n = 10 ) required more oral analgesics than the basal-bolus group ( P = 0.002 ) and had a shorter median infusion duration than the other two groups ( P < 0.001 for both ) .
RESULTS	The bolus group had the longest median infusion duration ( P < 0.001 for both ) but experienced an increase in breakthrough pain incidence ( P = 0.004 ) and intensity ( P = 0.04 vs. basal-bolus group ) as well as sleep disturbances ( P < 0.001 for both ) compared with the other groups .
RESULTS	Overall satisfaction was greatest in the basal-bolus group ( 9.7 + / - 0.5 vs. 7.9 + / - 1.7 and 8.1 + / - 1.5 ; P < 0.05 for both ) .
CONCLUSIONS	After moderately painful orthopedic surgery at or distal to the elbow , 0.2 % ropivacaine delivered as a continuous infusion combined with patient-controlled bolus doses via an infraclavicular perineural catheter optimizes analgesia while minimizing oral analgesic use compared with basal - or bolus-only dosing regimens .

###23751736
OBJECTIVE	Recent trials using intravascular ultrasound ( IVUS ) have shown that statins induce regression and stabilization of coronary artery plaques .
OBJECTIVE	However , there are no reports on whether regression and stabilization in coronary artery plaques associated with statin therapy continue or not .
OBJECTIVE	The purpose of the present study was to examine the time course of statin-induced changes in coronary atherosclerosis .
METHODS	Coronary atherosclerosis was evaluated using virtual histology-IVUS in 39 patients at the time of a percutaneous coronary intervention , 8 months after statin therapy ( mid-term ) , and at 48-month ( long-term ) follow-up .
METHODS	IVUS images qualified for evaluation obtained from 30 of these patients at three time points .
RESULTS	Significant decreases in low-density lipoprotein cholesterol and high-sensitivity C-reactive protein were observed at 8 months and these decreases continued for 48 months .
RESULTS	A decrease in external elastic membrane volume was observed at 8 months ( -1.1 % ) and reached significance at 48 months ( -5.9 % , P = 0.0001 ) .
RESULTS	Plaque volume tended to decrease over time , but this was not statistically significant ( -1.6 % at 8 months and -3.8 % at 48 months ) .
RESULTS	An increase in the calcified plaque component was observed at 8 months ( 0.090.34 mm/mm ) and reached significance at 48 months ( 0.210.33 mm/mm , P = 0.002 ) .
RESULTS	Change in the calcified component and change in the external elastic membrane volume showed a significant negative correlation at the long-term follow-up ( r = -0.598 , P = 0.0005 ) .
CONCLUSIONS	Continued negative vessel remodeling associated with an increase in the calcified plaque component was observed following prolonged statin therapy by serial virtual histology-IVUS analysis .

###14716694
OBJECTIVE	To examine the safety and efficacy of sertraline augmentation therapy in the treatment of behavioral manifestations of Alzheimer 's disease ( AD ) in outpatients treated with donepezil .
METHODS	Patients with probable or possible AD , and a Neuropsychiatric Inventory ( NPI ) total score > 5 ( with a severity score > or = 2 in at least one domain ) , were treated with donepezil ( 5-10 mg ) for 8 weeks , then randomly assigned to 12 weeks of double-blind augmentation therapy with either sertraline ( 50-200 mg ) or placebo .
METHODS	Primary efficacy measures were the 12-item Neuropsychiatric Inventory ( NPI ) and the Clinical Global Impression Improvement ( CGI-I ) and Severity ( CGI-S ) scales .
RESULTS	24 patients were treated with donepezil + sertraline and 120 patients with donepezil + placebo .
RESULTS	There were no statistically significant differences at endpoint on any of the three primary efficacy measures .
RESULTS	However , a linear mixed model analysis found modest but statistically significantly greater improvements in the CGI-I score on donepezil + sertraline .
RESULTS	Moreover , in a sub-group of patients with moderate-to-severe behavioral and psychological symptoms of dementia , 60 % of patients on sertraline vs 40 % on placebo ( p = 0.006 ) achieved a response ( defined as > or = 50 % reduction in a four-item NPI-behavioral subscale ) .
RESULTS	One adverse event ( diarrhea ) was significantly ( p < 0.05 ) more common in the donepezil + sertraline group compared to the donepezil + placebo group .
CONCLUSIONS	Sertraline augmentation was well-tolerated in this sample of AD outpatients .
CONCLUSIONS	In addition , post hoc analyses demonstrated a modest but statistically significant advantage of sertraline over placebo augmentation in mixed model analyses and a clinically and statistically significant advantage in a subgroup of patients with moderate-to-severe behavioral and psychological symptoms of dementia .

###22100003
OBJECTIVE	The best treatment modalities for large proximal ureteral stones are controversial , and include extracorporeal shock wave lithotripsy , ureterolithotripsy , percutaneous nephrolithotripsy , laparoscopic ureterolithotomy and open surgery .
OBJECTIVE	To the best of our knowledge extracorporeal shock wave lithotripsy , semirigid ureterolithotripsy and laparoscopic ureterolithotomy have not been previously compared for the treatment of large proximal ureteral stones .
OBJECTIVE	Therefore , we compared these modalities for the treatment of large proximal ureteral stones .
METHODS	A total of 48 patients with large proximal ureteral stones ( greater than 1 cm ) were prospectively randomized and enrolled in the study at a single institution between 2008 and 2010 .
METHODS	Eligible patients were assigned to extracorporeal shock wave lithotripsy , semirigid ureterolithotripsy or laparoscopic ureterolithotomy .
RESULTS	Extracorporeal shock wave lithotripsy had a 35.7 % success rate , semirigid ureterolithotripsy 62.5 % and laparoscopic ureterolithotomy 93.3 % .
RESULTS	Stone-free rates showed a statistically significant difference among the groups ( p = 0.005 ) .
RESULTS	Patients treated with laparoscopic ureterolithotomy vs semirigid ureterolithotripsy vs extracorporeal shock wave lithotripsy required fewer treatment sessions ( mean SD 1.9 0.3 vs 2.2 0.6 vs 2.9 1.4 , p = 0.027 ) .
RESULTS	Neither major nor long-term complications were observed .
CONCLUSIONS	Proximal ureteral stone treatment requires multiple procedures until complete stone-free status is achieved .
CONCLUSIONS	Laparoscopic ureterolithotomy is associated with higher success rates and fewer surgical procedures , but with more postoperative pain , longer procedures and a longer hospital stay .
CONCLUSIONS	Although it is associated with the highest success rates for large proximal ureteral calculi , laparoscopic ureterolithotomy remains a salvage , second line procedure , and it seems more advantageous than open ureterolithotomy .
CONCLUSIONS	At less well equipped centers , where semirigid ureterolithotripsy or extracorporeal shock wave lithotripsy is not available , it remains a good treatment option .

###8538922
BACKGROUND	In some vascular beds calcium-channel-blocking agents have been shown to possess some antagonism to endothelin-1 ( ET-1 ) - induced vasoconstriction .
BACKGROUND	This issue has not been well investigated in humans , however .
METHODS	The study had a double-blind cross-over design .
METHODS	In 12 healthy human volunteers we investigated the effect of pretreatment with either isradipine 10 mg daily for 1 week or placebo on changes in ( i ) systemic and renal haemodynamics and ( ii ) renal handling of sodium and water induced by intravenous infusion of ET-1 at a rate of 1 pmol/min/kg for 60 min .
RESULTS	Infusion of ET-1 affected systemic haemodynamics .
RESULTS	The increase in diastolic blood pressure was similar after pretreatment with placebo ( +6.8 % ) or isradipine ( +5.3 % ) .
RESULTS	The changes in renal haemodynamics in response to ET-1 infusion were also familiar , e.g. renal plasma flow ( -32.1 % versus -31.2 % ) , glomerular filtration rate ( -8.8 % versus -10.9 % ) and renal vascular resistance ( +55.1 % versus +52.7 % ) .
RESULTS	Likewise the changes in renal handling of sodium and water in response to ET-1 infusion were unaffected by pretreatment with placebo or isradipine , e.g. sodium excretion ( -44.6 % versus -40.8 % ) , urine flow rate ( -49.8 % versus -38.9 % ) and clearance of lithium ( -32.0 % versus -29.1 % ) .
CONCLUSIONS	Intravenous infusion of ET-1 in healthy humans discretely increases diastolic blood pressure and profoundly decreases renal haemodynamics and excretion of sodium and water .
CONCLUSIONS	Pretreatment with the calcium-channel blocking agent isradipine for 1 week in a clinically relevant dose does not interfere with the action of ET-1 .

###10711609
BACKGROUND	This clinical controlled study was designed to measure the tension of coronally advanced flaps ( CAF ) performed to treat shallow gingival recessions and to compare the recession reduction ( Rec Red ) achieved in a test group ( flaps with tension ) and in a control group ( flaps without tension ) 3 months after surgery .
METHODS	Eleven patients , aged 22 to 41 years , with high levels of oral hygiene ( full mouth plaque score < 20 % ) were selected for the study .
METHODS	Each patient showed 2 bilateral Miller Class I maxillary or mandibular gingival recessions located on homologous teeth .
METHODS	A total of 22 recessions were treated .
METHODS	The recession depth at the right site was similar to that at the left site ( difference < or = 1 mm ) .
METHODS	For each patient , the 2 recessions underwent CAF procedure in the same surgical session .
METHODS	Before suturing , the residual tension ( FTens ) of both right and left flaps was measured with a dynamometer .
METHODS	Then , one site was randomly assigned to the test group and the contralateral site to the control group .
METHODS	In the test site the flap was sutured .
METHODS	In the control site the flap was further relaxed , the tension was measured again , and the flap was sutured .
RESULTS	In the test group ( with tension ) the initial mean recession depth was 2.82 + / - 0.64 mm and mean FTens was 6.5 g , while in the control group ( without tension ) the initial mean recession depth was 2.68 + / - 0.81 mm and mean FTens was 0.4 g. Three months later , the test group showed a mean recession reduction of 2.18 + / - 0.60 mm , a mean percent root coverage of 78 + / - 15 % , and complete root coverage was achieved on 2 teeth ( 18 % ) .
RESULTS	In the control group the mean recession reduction was 2.32 + / - 0.81 mm and mean percent root coverage was 87 + / - 13 % .
RESULTS	Complete root coverage was obtained on 5 teeth ( 45 % ) .
RESULTS	The difference of recession reduction between the test and control group was not statistically significant ( P = 0.3911 ) .
RESULTS	In the test group , linear regression analysis showed a statistically significant association between recession reduction and both recession depth at baseline ( P = 0.0001 ) and mean of the 3 tensions recorded on the test side ( MFTens ) ( P = 0.0009 ) .
CONCLUSIONS	This study shows that minimal flap tension does not influence recession reduction after 3 months when shallow recessions are treated by means of CAF .
CONCLUSIONS	In the test group ( with tension ) , the statistical analysis suggests that the higher the flap tension , the lower the recession reduction .

###19361872
BACKGROUND	The evidence of antiatherogenic and vasodilatatory effects of testosterone ( T ) suggest a possible role of the lack of this hormone in the development and pathophysiology of coronary artery disease ( CAD ) .
BACKGROUND	Aim of the present study was to evaluate the effects of oral administration of testosterone undecanoate during a period of three months on serum lipid levels and on the occurrence of anginal attacks and daily ischemic episodes in patients with CAD .
RESULTS	Eighty seven ( 87 ) diabetic male subjects ( mean age : 74 + / -7 years ) with proven CAD were randomized to a 12 week treatment with either T undecanoate ( 40 mg administered three daily ) or placebo ( P ) in a double blind protocol .
RESULTS	Weekly episodes of angina attacks , number of ischemic episodes daily and total ischemic burden on ambulatory ECG Holter were evaluated at baseline and at the end of the study .
RESULTS	Serum total cholesterol and triglyceride concentrations were also measured at the same time points .
RESULTS	Compared to P , T significantly reduced the number of anginal attacks/weeks of 34 % ( p < 0.05 ) ; the silent ischemic episodes of 26 % ( p < 0.05 ) , and the total ischemic burden of 21 % ( p < 0.05 ) on ambulatory ECG monitoring .
RESULTS	After 12 weeks total cholesterol , plasma triglycerides and HOMA index were significantly reduced in the T group compared to P group .
CONCLUSIONS	Three months administration of T has beneficial effect on serum cholesterol and triglyceride levels in patients with CAD and reduces the number of anginal attacks , and ischemic episodes .
CONCLUSIONS	These effect may be related to the metabolic and vasoactive properties of the hormone .
CONCLUSIONS	Further studies are needed in order to assess the long term relevance of these effects .

###8150098
OBJECTIVE	To determine whether weight loss in obese , hyperandrogenic , anovulatory women is associated with resumption of ovulation and/or with changes in insulin , androgen , and gonadotropin concentrations .
METHODS	Prospective , randomized , controlled study .
METHODS	University research center .
METHODS	Twelve obese , hyperandrogenic , anovulatory women .
METHODS	Twelve-week weight loss program in treatment ( n = 6 ) ; 12-week `` waiting list '' in control group ( n = 6 ) .
METHODS	[ 1 ] Ovulation ; [ 2 ] fasting insulin and glucose measurements ; [ 3 ] sex hormone-binding globulin ( SHBG ) , total and non-SHBG T concentrations ; [ 4 ] LH pulse frequency , amplitude , and concentration ; and [ 5 ] FSH concentration .
RESULTS	In contrast with the control group who showed no change in weight , ovulation status , or hormone levels , women in the treatment group lost an average of 16.2 kg and showed a significant increase in SHBG , a significant decline in non-SHBG T , and a decline ( though nonsignificant ) in fasting insulin .
RESULTS	Four of six subjects resumed ovulation .
RESULTS	However , no changes were evident in LH pulse frequency or amplitude or in mean LH and FSH concentrations .
CONCLUSIONS	Weight loss in obese , hyperandrogenic , anovulatory women appears to reduce insulin and non-SHBG T concentrations despite the absence of a change in gonadotropin secretion and may lead to resumption of ovulation .

###22017808
BACKGROUND	The aim of this study is to examine the efficacy of mindfulness-based cognitive therapy ( MBCT ) in addition to treatment as usual ( TAU ) for recurrent depressive patients with and without a current depressive episode .
METHODS	A randomized , controlled trial comparing MBCT+TAU ( n = 102 ) with TAU alone ( n = 103 ) .
METHODS	The study population consisted of patients with three or more previous depressive episodes .
METHODS	Primary outcome measure was post-treatment depressive symptoms according to the Hamilton Rating Scale for Depression .
METHODS	Secondary outcome measures included the Beck Depression Inventory , rumination , worry and mindfulness skills .
METHODS	Group comparisons were carried out with linear mixed modelling , controlling for intra-group correlations .
METHODS	Additional mediation analyses were performed .
METHODS	Comparisons were made between patients with and without a current depressive episode .
RESULTS	Patients in the MBCT+TAU group reported less depressive symptoms , worry and rumination and increased levels of mindfulness skills compared with patients receiving TAU alone .
RESULTS	MBCT resulted in a comparable reduction of depressive symptoms for patients with and without a current depressive episode .
RESULTS	Additional analyses suggest that the reduction of depressive symptoms was mediated by decreased levels of rumination and worry .
CONCLUSIONS	The study findings suggest that MBCT is as effective for patients with recurrent depression who are currently depressed as for patients who are in remission .
CONCLUSIONS	Directions towards a better understanding of the mechanisms of action of MBCT are given , although future research is needed to support these hypotheses .

###16965639
BACKGROUND	Comorbid psychiatric illness can undermine outcomes among homeless persons undergoing addiction treatment , and psychiatric specialty care is not always readily available .
BACKGROUND	The prognosis for nonsubstance abuse psychiatric diagnoses among homeless persons receiving behaviorally-based addiction treatment , however , is little studied .
RESULTS	Data from an addiction treatment trial for 95 cocaine-dependent homeless persons ( 1996-1998 ) were used to profile psychiatric diagnoses at baseline and 6 months , including mood-related disorders ( e.g. depression ) and anxiety-related disorders ( e.g. post-traumatic stress disorder ) .
RESULTS	Treatment interventions , including systematic reinforcement for goal attainment , were behavioral in orientation .
RESULTS	There was a 32 % reduction in the prevalence of comorbid non-addiction psychiatric disorder from baseline to 6 months , with similar reductions in the prevalence of mood ( -32 % ) and anxiety-related disorders ( -20 % ) ( p = 0.12 ) .
CONCLUSIONS	Among cocaine-dependent homeless persons with psychiatric comorbidity undergoing behavioral addiction treatment , a reduction in comorbid psychiatric disorder prevalence was observed over 6 months .
CONCLUSIONS	Not all participants improved , suggesting that even evidence-based addiction treatment will prove insufficient for a meaningful proportion of the dually diagnosed homeless population .

###9009369
OBJECTIVE	to investigate , in the first report in Central Africa , the influence of tropical Mitomycin C on the recurrence rate and on the complications after surgical treatment for primary pterygium .
METHODS	Sixty-six patients with primary pterygia underwent excision of the lesion , leaving the sclera bare .
METHODS	Patients were randomized in two groups : in one group ( 36 eyes in 33 patients ) 0.04 % mitomycin C eye drops were used four times daily during two weeks or longer after surgery , the other group ( 41 eyes in 33 patients ) underwent only surgery .
METHODS	The mean follow-up period was 6 months ( range , one to 24 months ) .
RESULTS	seven ( 19.4 % ) pterygia recurred in the group of eyes treated with topical 0.04 % mitomycin C and 11 ( 26.8 % ) in the group of eyes treated without this drug .
RESULTS	This difference was not significant ( p > 0.05 ) .
RESULTS	Complications were observed in two ( 5.6 % ) eyes in group 1 and included conjunctival granuloma ( one eye ) and transient ocular hypertension .
RESULTS	In group 2 , complications were noted in four eyes ( 9.8 % ) and included conjunctival granulomas ( three eyes ) and symblepharon ( one eye ) .
RESULTS	Ocular hypertension could be due to instillation of mitomycin C. No group had significantly more complications .
CONCLUSIONS	primary excision of pterygium with postoperative instillation of 0.04 % mitomycin C had a higher rate of occurrence in this study than previously reported in Japan , in the USA and Europe .

###21744377
OBJECTIVE	This study evaluated duloxetine in the treatment of binge eating disorder ( BED ) with comorbid current depressive disorders .
METHODS	In this 12-week , double-blind , placebo-controlled trial , 40 patients with Diagnostic and Statistical Manual of Mental Disorders-IV-TR BED and a comorbid current depressive disorder received duloxetine ( N = 20 ) or placebo ( N = 20 ) .
METHODS	The primary outcome measure was weekly binge eating day frequency .
RESULTS	In the primary analysis , duloxetine ( mean 78.7 mg/day ) was superior to placebo in reducing weekly frequency of binge eating days ( p = .04 ) , binge eating episodes ( p = .02 ) , weight ( p = .04 ) , and Clinical Global Impression-Severity of Illness ratings for binge eating ( p = .02 ) and depressive disorders ( p = .01 ) .
RESULTS	Changes in body mass index and measures of eating pathology , depression , and anxiety did not differ between the two groups .
CONCLUSIONS	Duloxetine may be effective for reducing binge eating , weight , and global severity of illness in BED with a comorbid current depressive disorder , but this finding needs confirmation in larger , placebo-controlled trials .

###16942827
BACKGROUND	The EasyTube , which is constructed in a similar way to the Combitube , is a recently introduced alternative to tracheal intubation for airway management in emergency medicine .
OBJECTIVE	To determine if there is a difference in rate of , and time to , successful airway placement and ventilation using tracheal intubation , Combitube and EasyTube .
METHODS	Twenty-six paramedics , trained in tracheal intubation received additional training in the use of the Combitube and the EasyTube .
METHODS	Each participant performed all three methods twice in random order on a manikin .
METHODS	Time to successful ventilation ( presented as mean and standard deviation ) and success rate were recorded .
RESULTS	Mean time to successful ventilation was significantly longer for tracheal intubation ( 45.2 s ( S.D. = 15.8 ) ) than for the Combitube ( 36.0 s ( S.D. = 8.6 ) ) p = 0.002 and the EasyTube ( 38.0 s ( S.D. = 15.3 ) ) p = 0.023 with no difference between the latter ( p = 1.000 ) .
RESULTS	Success rate for the Combitube and EasyTube combined ( 103/104 ) was significantly higher than for tracheal intubation ( 45/52 ) with odds ratio 16.0 ( 95 % CI : 1.9-134 ) ; p = 0.002 .
CONCLUSIONS	For paramedics tested on manikins placement success rate was higher with less time required for the Combitube and Easytube than for tracheal intubation with no differences between the Combitube and EasyTube .

###12790209
OBJECTIVE	Sevoflurane has been used for the induction and maintenance of anaesthesia during cardiac surgery owing to its favourable haemodynamic effects .
OBJECTIVE	It has been suggested that it offers protection against myocardial ischaemia-reperfusion injury .
METHODS	We investigated the effect of sevoflurane on plasma concentrations of tumour necrosis factor-alpha ( TNF-alpha ) after ex vivo stimulation of whole-blood leukocytes by lipopolysaccharide from 20 patients undergoing coronary artery bypass surgery .
METHODS	The patients were randomized to two groups .
METHODS	Group 1 patients were induced and maintained with sevoflurane ; those in Group 2 were anaesthetized with moderate doses of midazolam-sufentanil .
METHODS	Blood samples were drawn from the patients on seven occasions from before induction of anaesthesia until 24 h after skin closure .
RESULTS	Plasma concentrations of TNF-alpha were lower in Group 1 than in Group 2 after cessation of cardiopulmonary bypass ( median ( interquartiles ) : 25 ( 21-30 ) versus 37 ( 28-79 ) pg mL ( -1 ) ; P < 0.05 ) and 24h after skin closure ( 196 ( 100-355 ) versus 382 ( 233-718 ) pg mL ( -1 ) ; P < 0.05 ) .
RESULTS	Postoperatively , two cases of myocardial infarction were recorded , one in each group .
RESULTS	Six patients in Group 2 needed continued inotropic support after the first morning to maintain haemodynamic stability versus one patient in Group 1 ( P < 0.05 ) .
RESULTS	The length of stay in the intensive care unit was significantly lower in Group 1 than in Group 2 ( mean + / - SD : 25 + / - 16 versus 54 + / - 30 h ; P < 0.05 ) .
CONCLUSIONS	Sevoflurane reduces production of TNF-alpha more than total intravenous anaesthesia with midazolam-sufentanil during cardiac surgery .
CONCLUSIONS	This may reduce cardiac morbidity and the length of stay in the intensive care unit .

###19712448
BACKGROUND	Orientation and mobility training ( O&M - training ) in using an identification cane , also called symbol cane , is provided to people with low vision to facilitate independent participation in the community .
BACKGROUND	In The Netherlands this training is mainly practice-based because a standardised and validly evaluated O&M - training in using the identification cane is lacking .
BACKGROUND	Recently a standardised O&M - training in using the identification cane was developed .
BACKGROUND	This training consists of two face-to-face sessions and one telephone session during which , in addition to usual care , the client 's needs regarding mobility are prioritised , and cognitive restructuring techniques , action planning and contracting are applied to facilitate the use of the cane .
BACKGROUND	This paper presents the design of a randomised controlled trial aimed to evaluate this standardised O&M - training in using the identification cane in older adults with low vision .
METHODS	A parallel group randomised controlled trial was designed to compare the standardised O&M - training with usual care , i.e. the O&M - training commonly provided by the mobility trainer .
METHODS	Community-dwelling older people who ask for support at a rehabilitation centre for people with visual impairment and who are likely to receive an O&M - training in using the identification cane are included in the trial ( N = 190 ) .
METHODS	The primary outcomes of the effect evaluation are ADL self care and visual functioning with respect to distance activities and mobility .
METHODS	Secondary outcomes include quality of life , feelings of anxiety , symptoms of depression , fear of falling , and falls history .
METHODS	Data for the effect evaluation are collected by means of telephone interviews at baseline , and at 5 and 17 weeks after the start of the O&M - training .
METHODS	In addition to an effect evaluation , a process evaluation to study the feasibility of the O&M - training is carried out .
CONCLUSIONS	The screening procedure for eligible participants started in November 2007 and will continue until October 2009 .
CONCLUSIONS	Preliminary findings regarding the evaluation are expected in the course of 2010 .
CONCLUSIONS	If the standardised O&M - training is more effective than the current O&M - training or , in case of equal effectiveness , is considered more feasible , the training will be embedded in the Dutch national instruction for mobility trainers .
BACKGROUND	ClinicalTrials.gov NCT00946062 .

###16731324
OBJECTIVE	To evaluate the effects of clonidine and ephedrine on propofol-induced pain and on hemodynamic changes during the induction sequence .
METHODS	This was a prospective , randomized , double-blind study .
METHODS	The study was conducted at a university hospital .
METHODS	200 ASA physical status I or II adult patients scheduled for elective surgery .
METHODS	Patients were randomly allocated to one of 4 groups ( 50 patients per group ) : clonidine-ephedrine ( CE ) , clonidine-saline ( CS ) , diazepam-ephedrine ( DE ) , and diazepam-saline ( DS ) .
METHODS	Thirty seconds after the administration of ephedrine or saline , propofol 2 mg/kg was infused at a rate of 18.3 mL/min .
METHODS	Patients were asked whether they had pain due to propofol injection .
METHODS	A blinded investigator evaluated the pain score : 0 = no pain , 1 = mild pain , 2 = severe pain without behavioral signs such as grimace or arm withdrawal movement , and 3 = severe pain accompanied by behavioral signs .
METHODS	Mean arterial blood pressure ( MAP ) and heart rate ( HR ) were measured at 1-minute intervals from just before the administration of ephedrine or saline to 5 minutes after the tracheal intubation .
RESULTS	Median pain score in CE was significantly lower than those in the other groups ( P < 0.0001 ) .
RESULTS	Pain scores in CS and DE were significantly lower than that in DS ( P < 0.05 ) .
RESULTS	Ephedrine increased HR in CE and DE ( P < 0.05 ) , but clonidine did not augment the effect .
RESULTS	Mean arterial blood pressure before tracheal intubation decreased to comparable values in all groups .
RESULTS	After the intubation , mean arterial blood pressure and HR in CE and CS were significantly lower than those in DE and DS ( P < 0.05 ) .
CONCLUSIONS	Combination of clonidine and ephedrine effectively reduced propofol-induced pain , but did not prevent propofol-induced hypotension .
CONCLUSIONS	Clonidine did not augment low dose of ephedrine-induced increase in HR and produced stable hemodynamic condition during the induction sequence .

###16184071
BACKGROUND	: In a small pilot trial , patients with atypical depression demonstrated significant positive therapeutic response to chromium picolinate .
BACKGROUND	This finding is of interest because of the demonstrated link between depression , decreased insulin sensitivity , and subsequent diabetes and chromium picolinate 's insulin enhancing effect .
METHODS	: In this double-blind , multicenter , 8-week replication study , 113 adult outpatients with atypical depression were randomized 2:1 to receive 600 mug/day of elemental chromium , as provided by chromium picolinate ( CrPic ) , or placebo .
METHODS	Primary efficacy measures were the 29-item Hamilton Depression Rating Scale ( HAM-D-29 ) and the Clinical Global Impressions Improvement Scale ( CGI-I ) .
RESULTS	: Of the 113 randomized patients , 110 ( 70 CrPic , 40 placebo ) constituted the intent-to-treat ( ITT ) population ( i.e. , received at least one dose of study medication and completed at least one efficacy evaluation ) and 75 ( 50 CrPic , 25 placebo ) were evaluable ( i.e. , took at least 80 % of study drug with no significant protocol deviations ) .
RESULTS	In the evaluable population , mean age was 46 years , 69 % were female , 81 % were Caucasian , and mean body mass index ( BMI ) was 29.7 .
RESULTS	There was no significant difference between the CrPic and placebo groups in both the ITT and evaluable populations on the primary efficacy measures , with both groups showing significant improvement from baseline on total HAM-D-29 scores during the course of treatment ( p < 0.0001 ) .
RESULTS	However , in the evaluable population , the CrPic group showed significant improvements from baseline compared with the placebo group on 4 HAM-D-29 items : appetite increase , increased eating , carbohydrate craving , and diurnal variation of feelings .
RESULTS	A supplemental analysis of data from the subset of 41 patients in the ITT population with high carbohydrate craving ( 26 CrPic , 15 placebo ; mean BMI = 31.1 ) showed that the CrPic patients had significantly greater response on total HAM-D-29 scores than the placebo group ( 65 % vs. 33 % ; p < 0.05 ) as well as significantly greater improvements on the following HAM-D-29 items : appetite increase , increased eating , carbohydrate craving , and genital symptoms ( e.g. , level of libido ) .
RESULTS	Chromium treatment was well-tolerated .
CONCLUSIONS	: The study did not include a placebo run-in period , did not require minimum duration or severity of depression , and enrolled patients with major depression , dysthymia , or depression NOS .
CONCLUSIONS	: In a population of adults with atypical depression , most of whom were overweight or obese , CrPic produced improvement on the following HAM-D-29 items : appetite increase , increased eating , carbohydrate craving , and diurnal variation of feelings .
CONCLUSIONS	In a subpopulation of patients with high carbohydrate craving , overall HAM-D-29 scores improved significantly in patients treated with CrPic compared with placebo .
CONCLUSIONS	The results of this study suggest that the main effect of chromium was on carbohydrate craving and appetite regulation in depressed patients and that 600 mug of elemental chromium may be beneficial for patients with atypical depression who also have severe carbohydrate craving .
CONCLUSIONS	Further studies are needed to evaluate chromium in depressed patients specifically selected for symptoms of increased appetite and carbohydrate craving as well as to determine whether a higher dose of chromium would have an effect on mood .

###15705120
OBJECTIVE	To evaluate the efficacy and safety of venlafaxine in the prophylaxis of migraine .
BACKGROUND	The efficacy of venlafaxine , which is selectively effective on the serotonergic and noradrenergic mechanisms , on various headaches and chronic pain syndromes has been demonstrated .
BACKGROUND	To our knowledge , this is the first placebo-controlled , double-blind , randomized study of two different doses of venlafaxine for migraine treatment .
METHODS	In this prospective study , 60 migraine patients without aura were randomly assigned to venlafaxine XR 75 mg , venlafaxine XR 150 mg , or placebo .
METHODS	The frequency of headache attacks , the severity and the duration of attacks , and analgesic use were monitored every 2 weeks for 2 months .
METHODS	Adverse events and patient satisfaction were also evaluated during these visits .
METHODS	At the end of the 2 months , global efficacy and tolerance were investigated .
RESULTS	A significant difference was observed between the venlafaxine 150 mg and placebo groups in the number of headache attacks ( P = .006 ) .
RESULTS	According to patient satisfaction comparisons , the active drug groups were significantly different when compared with placebo ( P = .001 at visit 2 and visit 6 ) .
RESULTS	When the global efficacy was considered , 80 % of patients in the 75-mg group and 88.2 % of the patients in the 150-mg group evaluated treatment benefits as either good or very good .
CONCLUSIONS	Venlafaxine was more effective than placebo and is safe and well tolerated as migraine prophylaxis .

###24704801
BACKGROUND	The vertebral column is the most common site of bone metastases irrespective of the primary tumor .
BACKGROUND	Vertebral metastases are a major cause of motor deficit of the lower extremities .
BACKGROUND	The use of radiotherapy is the treatment of choice in these patients .
BACKGROUND	A temporary worsening of pain shortly during the course of palliative radiotherapy is clinically a common problem .
BACKGROUND	Steroid infusion has well-documented neuroprotective effects .
OBJECTIVE	Our study objective is to evaluate the effect of pre-emptive infusion of methylprednisolone on pain flare and motor function in patients with vertebral metastases .
METHODS	One hundred twenty patients with vertebral metastases received short-course external beam radiotherapy as high-voltage irradiation with a 6 MeV , via linear accelerator .
METHODS	In addition to the short-course radiotherapy , 60 patients received pre-emptive methylprednisolone infusion ( 5 mg/kg ) the day just before initiation of radiotherapy ( Group 1 [ G1 ] ) .
METHODS	The other 60 patients received short-course radiotherapy without pretreatment methylprednisolone infusion , and only normal saline was infused ( Group 2 [ G2 ] ) .
METHODS	The Brief Pain Inventory , incidence of pain flare during radiotherapy , and motor functions were evaluated using the Tomita scale at the time of initial assessment , at the end of external beam radiotherapy , and after two weeks .
RESULTS	Four patients ( 6.6 % ) in G1 experienced pain flare compared with 12 patients ( 20 % ) in G2 during the two-week short-course radiotherapy .
RESULTS	The mean values of pain scores were significantly reduced in both groups at the end of radiotherapy ; the mean value of worst , average , and current pain scores in G1 remained statistically significant in comparison to pretreatment and G2 mean values two weeks later .
RESULTS	Significant increase was noticed in patients with normal motor and ambulatory status in G1 at two and four weeks of initial assessment .
CONCLUSIONS	Pre-emptive methylprednisolone infusion is an effective prophylactic agent in the prevention of radiation-induced pain flare and improves functional motor status after short-term radiotherapy in patients with vertebral metastases .

###19531929
OBJECTIVE	To assess the effects of antiretroviral therapy ( ART ) on bone mineral density ( BMD ) DESIGN : Randomized comparison of continuous ART ( viral suppression group ; VS ) with intermittent ART ( drug conservation group ; DC ) SETTING : Outpatient clinics in the United States , Australia , and Spain .
METHODS	Participants in the Strategies for Management of Antiretroviral Therapy ( SMART ) Body Composition substudy .
METHODS	Annual hip and spine BMD by dual-energy radiographic absorptiometry ( DXA ) and spine BMD by quantitative computed tomography ( qCT ) .
METHODS	Comparisons were by intention-to-treat analysis , using longitudinal models for change in BMD .
METHODS	Risk factors for BMD loss were evaluated .
RESULTS	The 214 participants ( median 44 years , 19 % female participants , 73 % on ART ; median T-scores -0.5 total hip , -0.7 spine DXA , -0.9 spine qCT ; 98 randomized to VS and 116 to DC ) were followed for a mean 2.4 years .
RESULTS	With continuous ART , BMD declined per year by 0.8 % ( hip ) , 0.4 % ( spine DXA ) , and 2.4 % ( spine qCT ) .
RESULTS	BMD declined significantly less with intermittent ART .
RESULTS	Estimated DC minus VS group differences in mean BMD change through follow-up were 1.4 % [ hip ; 95 % confidence interval ( CI ) 0.6-2 .3 ; P = 0.002 ] , 1.3 % ( spine DXA ; 95 % CI 0.1-2 .4 , P = 0.03 ) , and 3.0 % ( spine qCT ; 95 % CI 0.8-5 .2 , P = 0.007 ) .
RESULTS	No consistent drug-specific association with BMD decline was found .
RESULTS	In the parent study , 10 of 2753 participants in the VS group and two of 2720 in the DC group reported serious fractures ( hazard ratio 4.9 ; 95 % CI 1.1-22 .5 ; P = 0.04 ) .
CONCLUSIONS	Continuous ART is associated with decline in BMD and possibly more fractures relative to intermittent , CD4 cell count-guided ART .

###15560810
OBJECTIVE	A single centre , randomised single-blind , three-way crossover study was performed , to compare the effect of an experimental test toothpaste with a commercially available whitening toothpaste and water control at inhibiting extrinsic stain promoted by repeated chlorhexidine/tea rinses .
METHODS	This study used 23 subjects .
METHODS	During the week before the study the subjects received a prophylaxis to remove all staining , plaque and calculus deposits .
METHODS	On the Monday of the following week subjects returned to the clinic to receive their rinses and to check their dentition was stain free .
METHODS	Under direct supervision at both 09:00 and 13:00 hours they rinsed with either a toothpaste slurry or water control that was repeated daily up to and including the following Thursday .
METHODS	Additionally from the Monday to the Thursday each subject rinsed with a 0.2 % chlorhexidine mouthrinse , immediately followed by a rinse with a warm black tea solution .
METHODS	This cycle was repeated hourly eight times throughout the day and on the following days until the Friday .
METHODS	Throughout this period volunteers omitted all other forms of oral hygiene except rinsing with the chlorhexidine mouthwash .
METHODS	On the Friday the level of stain on the teeth and dorsum of tongue was assessed using the Lobene stain index for both stain area and intensity .
METHODS	At the end of each trial period each subject received a thorough prophylaxis to remove all plaque , calculus and staining before starting the second and third period of the study .
RESULTS	As expected appreciable amounts of extrinsic stain accumulated on the teeth over each study period .
RESULTS	The amount of stain following use of the toothpastes and water control was least with the experimental toothpaste , followed by water control and lastly the commercial whitening paste .
RESULTS	For all sites combined there was evidence that the experimental paste was significantly superior to both the commercial paste and water control at reducing stain area ( p < 0.001 ) , a product of stain area and intensity ( p < 0.001 and 0.05 , respectively ) but not stain intensity ( p > 0.05 ) .
CONCLUSIONS	In this stain-prevention model the use of an experimental paste showed a significant reduction in stain accumulation on the teeth compared with a ( placebo ) negative water control and a commercially available whitening paste .
CONCLUSIONS	As such the experimental paste would be expected to be of benefit in controlling extrinsic dental staining .

###21679106
BACKGROUND	Platelet transfusion is required in the acute phase of some thrombocytopenic disorders in order to prevent potentially dangerous hemorrhages.The purpose of this study was to assess the increase in platelet count following a slow platelet transfusion .
METHODS	Patients suffering from thrombocytopenia due to various underlying diseases were enrolled in the prospective pilot feasibility trial and were randomly divided into two groups .
METHODS	Standard platelet transfusion was administered in one group , while slow transfusion was used in the other .
METHODS	The platelet count was examined at 1 hour , 24 hours , and 1 week following the transfusions .
RESULTS	Although the platelet count was higher following 1 hour after transfusion via the standard method , the count tended to be higher 1 week after the transfusion in the slow transfusion group .
RESULTS	This difference , however , only turned out to be statistically significant amongst females .
CONCLUSIONS	A therapy of slow platelet transfusion might be more effective for the prevention of platelet loss .
CONCLUSIONS	Further studies will be required to strengthen this hypothesis .

###25142002
BACKGROUND	Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration .
OBJECTIVE	To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized phase 2A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy ( DCM ) stratified by ischemic or nonischemic status .
RESULTS	In IMPACT-DCM , patients were randomized to either ixmyelocel-T or standard-of-care control in a 3:1 ratio ( n = 39 ) ; ixmyelocel-T was administered intramyocardially via minithoracotomy .
RESULTS	In Catheter-DCM , patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio ( n = 22 ) ; ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter .
RESULTS	Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections .
RESULTS	In the 2 studies , a total of 61 patients were randomized , and 59 were treated or received standard of care .
RESULTS	Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients .
RESULTS	A similar benefit was not seen in the nonischemic patients .
RESULTS	Heart failure exacerbation was the most common major adverse cardiovascular event .
RESULTS	Ixmyelocel-T treatment was associated with improved New York Heart Association class , 6-minute walk distance , and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control ; a similar trend was not observed in the nonischemic population .
CONCLUSIONS	Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM .

###16492621
OBJECTIVE	To clarify the relations between the sensory , affective and cognitive dimensions of pain and to analyse what influence these components have on persistent disability in patients with subacute whiplash-associated disorders ( WAD ) .
METHODS	The data was obtained from an on-going randomised controlled trial ( RCT ) on 47 patients .
METHODS	The sensory dimension of pain was evaluated with a visual analogue scale ( VAS ) diary and a Painometer .
METHODS	The affective dimension was assessed using the Painometer .
METHODS	The Tampa Scale for Kinesiophobia ( TSK ) and the Self-Efficacy Scale ( SES ) were used as measures of pain-related cognitions .
METHODS	The Pain Disability Index ( PDI ) was used as the outcome measure .
RESULTS	Forty patients ( 85 % ) completed the trial .
RESULTS	The correlations between the sensory and affective dimensions of pain were non-significant , which indicates that they are two independent constructs that describe various dimensions of whiplash-related pain .
RESULTS	High pain intensity and pain affect , more widespread pain , and high fear of movement / ( re ) injury corresponded to low self-efficacy .
RESULTS	Multiple regression analyses showed that self-efficacy was the most important predictor of persistent disability contributing to 42 % of the variation in the PDI score .
CONCLUSIONS	The treatment approach for patients with subacute WAD should incorporate the multidimensional nature of pain and to prevent disability special effort should be made to enhance the patient 's self-efficacy beliefs .

###9599360
OBJECTIVE	To compare the safety and efficacy of topical nonsteroidal antiinflammatory drugs ( NSAIDs ) for the control of pain after excimer laser photorefractive keratectomy ( PRK ) .
METHODS	One hundred twenty informed patients were enrolled in a double-masked , randomized , comparative study and assigned to either 0.1 % indomethacin , 0.1 % diclofenac , or placebo treatment .
METHODS	Subjective postoperative pain , symptoms , re-epithelialization rate , and systemic medications were monitored for 2 days following photoablation .
RESULTS	Compared with the placebo , 0.1 % indomethacin solution significantly reduced pain on the day of surgery ( D0 ) ( P < .05 ) , whereas 0.1 % diclofenac did not reach a significant level ( P = .46 ) .
RESULTS	At D0 , analgesic intake by the oral route was significantly greater in the placebo group ( P < .05 ) .
RESULTS	Severe photophobia was significantly less frequent in the group treated with 0.1 % indomethacin ( P < .05 ) .
RESULTS	Corneal wound healing was significantly delayed in the patients treated with 0.1 % diclofenac at D2 as compared with other groups ( P = .04 ) .
CONCLUSIONS	Topical 0.1 % indomethacin solution helps control the pain induced by excimer laser photoablation of the cornea without any detrimental effect to the corneal epithelial wound healing .

###21481958
OBJECTIVE	Inotrope treatment is often necessary in refractory to optimal management end stage heart failure , when signs of end-organ hypoperfusion appear .
OBJECTIVE	The effect of specific inotropes on patient outcome remains controversial .
OBJECTIVE	The aim of the study was to compare the effect of levosimendan versus dobutamine , alone or in combination with levosimendan , on the outcome of end-stage heart failure patients , requiring inotropic therapy .
RESULTS	We studied 63 patients in NYHA class IV , refractory to optimal medical therapy , recently hospitalized for cardiac decompensation and stabilized by an intravenous inotrope .
RESULTS	They were randomly assigned to intermittent infusions of either a ) dobutamine , 10mg/kg/min , versus b ) levosimendan , 0.3 mg/kg/min , versus c ) dobutamine , 10mg/kg/min + levosimendan 0.2 mg/kg/min , each administered weekly , for 6h , over a 6-month period .
RESULTS	All patients received amiodarone , 400 mg/day , to suppress the proarrhythmic effects of the inotropes .
RESULTS	Baseline characteristics of the 3 groups were similar .
RESULTS	At 6 months , survival free from death or urgent left ventricular device implantation was 80 % in the levosimendan , 48 % in the dobutamine ( P = 0.037 versus levosimendan ) , and 43 % in the levosimendan + dobutamine ( P = 0.009 versus levosimendan ) group .
RESULTS	At 3months , NYHA class improved significantly in all 3 groups , whereas pulmonary capillary wedge pressure decreased ( 27 4 to 19 8 mmHg , P = 0.008 ) and cardiac index increased ( 1.5 0.3 to 2.1 0.3 l/min/m ( 2 ) , P = 0.002 ) significantly only in patients assigned to levosimendan .
CONCLUSIONS	In patients with refractory end-stage heart failure , intermittent administration of levosimendan conferred survival and hemodynamic benefits in comparison to a regimen of intermittent infusions of dobutamine , alone or in combination with levosimendan .

###23164323
BACKGROUND	The biological fixation of an implant to bone is influenced by numerous factors , including surface chemistry and surface topography .
BACKGROUND	Various methods have been developed to create rough implant surfaces in order to improve the clinical performance of implants and to guarantee a stable mechanical bone-implant interface .
BACKGROUND	Anodic oxidation is a dental implant surface modification technique that results in oxide layer growth up to a thickness of 110 micron .
BACKGROUND	The purpose of this study was to evaluate the performance of the surface through the osteoblasts cells growth and the influence of oxidixed surface on BIC percent , in the human posterior maxilla after 2 months of unloaded healing .
METHODS	In vitro commercially available primary human osteoblasts ( NHOst ) from both femur and tibia of different donor systems ( Lonza Walkersville Inc , Walkersville , MD , USA ) were grown in Osteoblast Growth Media ( OBM ) ( Lonza ) .
METHODS	Osteogenic differentiation was induced for a period of 4 weeks by the OGM medium ( OBM basal medium supplemented with 200nM of hydrocortisone-21-hemisuccinate and 7.5 mM of glycerophosphate ) .
METHODS	The viability of NHOst cells seeded test A and B was measured by the quantitative colorimetric MTT ( 3 - [ 4,5-dimethyl-2-thiazolyl ] -2,5 - diphenyl-2Htetrazoliumbromide test ) ( Promega , Milan , Italy ) .
METHODS	One custom-made 2 x 10-mm site evaluation implant ( SEI ) with nanometer scale and oxidized surface ( test ) ( Evo Plan 1 Health s.r.l. - Amaro , UD , Italy ) , and one SEI with hydroxyapatite sandblasted surface ( control ) ( Osseogrip Plan 1 Health s.r.l. Amaro , UD , Italy ) , were placed in the posterior maxilla of 15 patients .
METHODS	Patients received one of each type of SEI placed on controlateral side .
RESULTS	The proliferation rate studied by the MTT assay showed that during the incubation time , starting at 24 h , an increased proliferation rate was evident in Test B respect to Test A.
RESULTS	After 2 months of unloaded healing BIC percent was significantly higher in oxidized implants .
RESULTS	BIC percent mean values for the Osseogrip surface was 36,133 + / -4,888 ER and 53,533 + / - 5,180 ER for the Evo surface ( P = 0,028 ) .
CONCLUSIONS	These results seem to confirm that implant surface topography entails mechanical restrictions to the spread and locomotion of the cells involved in bone healing .

###16504835
OBJECTIVE	Macrovascular disease ( MVD ) , especially coronary heart disease , is the most common cause of mortality in Type 2 diabetes .
OBJECTIVE	We assessed the association between demographic and clinical variables ( particularly HbA1c ) and prevalent MVD at time of enrollment into the VA Diabetes Trial ( VADT ) , a 7-year randomized trial to determine whether intensive glycemic control will reduce risk of MVD events in older participants with established Type 2 diabetes .
METHODS	We compared the demographic , treatment , and clinical characteristics of participants with and without known MVD , then assessed the interaction of multiple variables with HbA1c .
METHODS	Logistic regression models evaluated the association between HbA1c quartiles and prevalence of MVD , adjusting for potentially confounding variables .
RESULTS	Several variables were associated with prevalent MVD ( age , duration of diabetes , insulin use but not daily dosage , smoking history , hypertension , BMI , Caucasian race , non-Hispanic ethnicity , lower HDL cholesterol , higher triglycerides , lower LDL cholesterol , and statin use ) .
RESULTS	In univariate analysis , there was no association of HbA1c with MVD ( mean : 9.4 + / -1.46 % in those with MVD , 9.5 + / -1.58 % in those without ) .
RESULTS	Multivariate analyses found little confounding of the lack of association of HbA1c with MVD .
RESULTS	Only adjustment for age produced a slight increase in the odds ratio , but only for the highest quartile of HbA1c .
CONCLUSIONS	In this cross-sectional analysis , MVD was associated with a number of clinical and demographic variables but not with HbA1c .
CONCLUSIONS	Determining whether intensive lowering of HbA1c will reduce the prospective rate of MVD events in this population of older participants with established Type 2 diabetes is the primary objective of our trial .

###12971846
OBJECTIVE	To compare the difference of intracranial pressure ( ICP ) in patients with hypertensive intracerebral hemorrhage ( HICH ) treated with two surgical procedures , traditional craniotomy and puncture drainage .
METHODS	One hundred and twelve cases with HICH were randomly divided into two groups .
METHODS	In one group , 60 patients were operated by traditional craniotomy and in another group , 52 cases by puncture drainage and urokinase treatment .
METHODS	In the meantime , ICP was monitored by placing catheter in lateral ventricle on the contralateral side of the hemorrhage .
METHODS	ICP values were recorded after operation at once , at 24 hours , 72 hours and 1 week .
RESULTS	Although all the patients showed increased ICP , the increasing degree in patients treated with traditional craniotomy had lower ICP values ( P < 0.05 or P < 0.01 ) .
CONCLUSIONS	Traditional craniotomy has advantages over puncture drainage for patients with HICH at least with respect to decreasing ICP .

###21062674
OBJECTIVE	To determine whether continuous subcutaneous insulin infusion ( CSII ) or multiple daily injections of insulin ( MDI ) are associated with improved glycemic variability .
METHODS	Type 2 diabetic patients 60 years of age were randomized to 12 months of CSII ( n = 53 ) or MDI ( n = 54 ) therapy .
METHODS	Patients were asked to complete monthly eight-point self-monitored glucose profiles ( n = 78 ) and continuous glucose monitoring systems ( CGMS ) for up to 72 h at Months 0 , 6 , and 12 ( n = 77 ) .
METHODS	Within-day mean glucose , standard deviation ( SD ) , range , pre - and post-prandial glucose , M value , and mean amplitude of glycemic excursions ( MAGE ) were calculated from eight-point profiles .
METHODS	Mean glucose , SD , range , area under the curve ( AUC ) high ( > 180 mg/dl ) and AUC-low ( < 70 mg/dl ) were calculated from CGMS .
METHODS	Mixed model analyses of variance were used to examine the associations between treatment , time , and the study outcomes , adjusting for any effects of sex .
RESULTS	With the use of the eight-point profiles , CSII and MDI groups did not differ with respect to mean glucose , mean pre-prandial and post-prandial glucose , SD , range , M value , or MAGE .
RESULTS	With the CGMS data , there were no significant between-group differences in measures of mean glucose , range , SD , AUC-high , or AUC-low .
RESULTS	In both treatment groups , all measures improved over time ( P < .0001 ) except for AUC-low ( P = .68 ) which did not change .
RESULTS	There were treatment-by-time interactions when considering the CGMS range ( P = .04 ) and AUC-high ( P = .001 ) , but no significant differences were found at individual time points .
CONCLUSIONS	Glucose variability improved equally with CSII and MDI treatment in older patients with type 2 diabetes .

###21668963
BACKGROUND	Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life .
BACKGROUND	Fatigue was assessed as a secondary objective in a 2-phase , 24-week study in outpatients with American College of Rheumatology-defined fibromyalgia .
METHODS	Patients were randomized to duloxetine 60-120 mg/d ( N = 263 ) or placebo ( N = 267 ) for the 12-week acute phase .
METHODS	At Week 12 , all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase .
METHODS	Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory ( MFI ) scales : General Fatigue , Physical Fatigue , Mental Fatigue , Reduced Activity , and Reduced Motivation .
METHODS	Other assessments that may be associated with fatigue included Brief Pain Inventory ( BPI ) average pain , numerical scales to rate anxiety , depressed mood , bothered by sleep difficulties , and musculoskeletal stiffness .
METHODS	Treatment-emergent fatigue-related events were also assessed .
METHODS	Changes from baseline to Week 12 , and from Week 12 to Week 24 , were analyzed by mixed-effects model repeated measures analysis .
RESULTS	At Week 12 , duloxetine versus placebo significantly ( all p < .05 ) reduced ratings on each MFI scale , BPI pain , anxiety , depressed mood , and stiffness .
RESULTS	Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8 .
RESULTS	At Week 24 , mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks ( n = 176 ) .
RESULTS	Placebo-treated patients switched to duloxetine ( n = 187 ) had significant within-group improvement in Physical Fatigue ( Weeks 16 , 20 , and 24 ) ; General Fatigue ( Weeks 20 and 24 ) ; Mental Fatigue ( Week 20 ) ; and Reduced Activity ( Weeks 20 and 24 ) .
RESULTS	These patients also experienced significant within-group improvement in BPI pain , anxiety , depressed mood , bothered by sleep difficulties , and stiffness .
RESULTS	Overall , the most common ( > 5 % incidence ) fatigue-related treatment-emergent adverse events were fatigue , somnolence , and insomnia .
CONCLUSIONS	Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia , and improvement was maintained for up to 24 weeks .
BACKGROUND	ClinicalTrials.gov registry NCT00673452 .

###15089810
OBJECTIVE	The aim of this analysis was to develop a population pharmacokinetic model for Emfilermin ( recombinant human leukaemia inhibitory factor , r-hLIF ) following subcutaneous administration to healthy postmenopausal women and to infertile patients undergoing in vitro fertilization and embryo transfer ( IVF-ET ) .
METHODS	Data from three studies , a single and a repeat dose Phase I study in postmenopausal women as well as a proof of concept study in patients undergoing in vitro fertilization and embryo transfer were combined and analyzed .
METHODS	The structural pharmacokinetic model was developed using the rich data from the Phase I studies and the full pharmacostatistical model was then derived using all the data .
RESULTS	The pharmacokinetics of r-hLIF after repeated subcutaneous administration were described by a one-compartment disposition model with a zero order input .
RESULTS	The duration of the absorption phase was short ( 0.8 h ) and invariant .
RESULTS	The apparent clearance in postmenopausal women was 57 l h ( -1 ) ( CV = 17 % ) .
RESULTS	In in vitro fertilization and embryo transfer patients , the apparent clearance was decreased by 35 % compared with postmenopausal women .
RESULTS	The apparent volume of distribution was 235 l ( interindividual CV = 28 % ) and exhibited an interoccasion variability of 23 % .
RESULTS	It increased ( for weight above 62 kg ) or decreased ( for weight below 62 kg ) by 29 % for every 10 kg body weight .
RESULTS	The median posthoc estimates of apparent clearance and volume of distribution and their variability were consistent with the population estimates .
RESULTS	In postmenopausal women , the results were consistent with those obtained by noncompartmental analysis .
RESULTS	The residual variability on r-hLIF serum concentrations was 20 % .
CONCLUSIONS	The pharmacokinetics of r-hLIF after repeated SC administration were described by a one compartment disposition model , with zero order input , in postmenopausal women and those undergoing IVF or intracytoplasmic sperm injection and embryo transfer .
CONCLUSIONS	Absorption of r-hLIF was rapid as was its subsequent clearance .
CONCLUSIONS	The apparent volume of distribution of r-hLIF was moderate to high , depended on body weight and showed interoccasion variability .

###23949071
OBJECTIVE	To determine the repeated passive movement ( RPM ) and repeated active movement ( RAM ) exercise on position sense of the knee joint in patients with hemiplegia .
METHODS	45 hemiplegia patients were randomly allocated to either the control group ( no exercise ) , RPM group , or RAM group , with 15 subjects in each group .
METHODS	The exercise was repeated 60 times on the angle 10 to 100 degrees of the knee joint with an angle speed of 120/s , with three sets for 15 minutes .
METHODS	Evaluation was performed using Passive Angle Repositioning ( PAR ) and Active Angle Repositioning ( AAR ) .
RESULTS	Error of positioning sense showed a decrease in PAR and AAR in the RPM group ( p < 0.01 ) and an increase in AAR was observed in the RAM group ( p < 0.05 ) .
RESULTS	In comparison of knee joint position sense error value and rate of change among the three groups , the RPM group is decreased mostly in PAR and AAR ( p < 0.01 ) , and Error value ( p < 0.05 ) and rate of change ( p < 0.01 ) of the RAM group showed a greater increase in AAR than the control group .
CONCLUSIONS	RAM exercise can support an increase in proprioception on the knee joint of hemiplegia ; however , RAM exercise that causes fatigue can decrease proprioception .

###24075427
OBJECTIVE	To investigate effects of enoxaparin on postoperative inflammation in patients with moderate nonproliferative diabetic retinopathy ( NPDR ) and nuclear cataract .
METHODS	Prospective masked controlled trial .
METHODS	setting : Institutional practice .
METHODS	study population : The study included 51 eyes of 51 diabetes mellitus ( DM ) patients with moderate NPDR and grade 2-3 nuclear cataracts .
METHODS	Group 1 included randomly selected patients who received enoxaparin in balanced salt solution ( BSS ) during cataract surgery , while standard BSS was used in Group 2 .
METHODS	observation procedure : Patients were followed up 1day , 1week , and 1 and 2months after the surgery .
METHODS	main outcome measures : Anterior chamber cell and flare .
RESULTS	Postoperatively , 20 patients from Group 1 and 4 patients in Group 2 had less than a mean of 10 cells at day 1 ( P = .012 ) .
RESULTS	At the first week , 20 patients from Group 1 and 10 patients from Group 2 had less than a mean of 10 cells ( P = .004 ) .
RESULTS	When compared for flare , 20 patients from Group 1 and 8 patients from Group 2 had a flare between 0 and +1 at postoperative day 1 ( P < .001 ) .
RESULTS	By the end of postoperative first week , 24 patients from Group 1and 18 patients from Group 2 had a flare between 0 and +1 ( P = .012 ) .
RESULTS	There was no difference between groups in terms of postoperative inflammation at the first and second months after the surgery .
CONCLUSIONS	The results of the study suggest that enoxaparin added into the infusion fluid may reduce postoperative inflammation in patients with DM , and this result supports the anti-inflammatory effect of enoxaparin .

###24096919
BACKGROUND	A simulator for virtual radiographic examinations was developed .
BACKGROUND	In the virtual environment , the user can perform and analyze radiographic examinations of patient models without the use of ionizing radiation .
BACKGROUND	We investigated if this simulation technique could improve education of radiology technology students .
BACKGROUND	We compared student performance in the assessment of radiographic image quality after training with a conventional manikin or with the virtual radiography simulator .
METHODS	A randomized controlled experimental study involving 31 first-year radiology technology students was performed .
METHODS	It was organized in 4 phases as follows : ( I ) randomization to control or experimental group based on the results of an anatomy examination ; ( II ) proficiency testing before training ; ( III ) intervention ( control group , exposure and analysis of radiographic images of the cervical spine of a manikin ; experimental group , exposure and analysis of the cervical spine images in the virtual radiography simulator ) ; and ( IV ) proficiency testing after training .
RESULTS	The experimental group showed significantly higher scores after training compared with those before training ( P < 0.01 ) .
RESULTS	A linear mixed-effect analysis revealed a significant difference between the control and experimental groups regarding proficiency change ( P = 0.01 ) .
CONCLUSIONS	Virtual radiographic simulation is an effective tool for learning image quality assessment .
CONCLUSIONS	Simulation can therefore be a valuable adjunct to traditional educational methods and reduce exposure to x-rays and tutoring time .

###16826474
BACKGROUND	There is an urgent need to deploy and develop new control tools that will reduce the intolerable burden of malaria .
BACKGROUND	Intermittent preventive treatment in infants ( IPTi ) has the potential to become an effective tool for malaria control .
METHODS	We performed a randomized , double-blind , placebo-controlled trial of sulfadoxine-pyrimethamine ( SP ) treatment in 1503 Mozambican children .
METHODS	Doses of SP or placebo were given at 3 , 4 , and 9 months of age .
METHODS	The intervention was administered alongside routine vaccinations delivered through the Expanded Program on Immunization ( EPI ) .
METHODS	Hematological and biochemical tests were done when infants were 5 months old .
METHODS	Morbidity monitoring through a hospital-based passive case-detection system was complemented by cross-sectional surveys when infants were 12 and 24 months old .
RESULTS	IPTi was well tolerated , and no adverse events associated with SP were documented .
RESULTS	During the first year of life , intermittent SP treatment reduced the incidence of clinical malaria by 22.2 % ( 95 % confidence interval [ CI ] , 3.7 % -37.0 % ; P = .020 ) and the rate of hospital admissions by 19 % ( 95 % CI , 4.0 % -31.0 % ; P = .014 ) .
RESULTS	Although the incidence of severe anemia ( packed cell volume of < 25 % ) did not differ significantly between the 2 groups ( protective effect , 12.7 % [ 95 % CI , -17.3 % to 35.1 % ] ; P = .36 ) , there was a significant reduction in hospital admissions for anemia during the month after dosing for both the first and second dose .
RESULTS	The serological responses to EPI vaccines were not modified by the intervention .
CONCLUSIONS	IPTi with SP has been shown to moderately reduce the incidence of clinical malaria in Mozambican infants without evidence of rebound after stopping the intervention or of interactions with EPI vaccines .
CONCLUSIONS	Its recommendation as a malaria control strategy in Mozambique needs to be balanced against the scarcity of affordable control tools and the burden of malaria in children .

###16620334
OBJECTIVE	This study aimed to evaluate differences in post-operative pain comparing KTP laser-assisted uvulopalatoplasty without tonsillectomy ( LAUP ) with a new described surgical method : coblation uvulopalatoplasty with tonsillectomy ( CP ) .
OBJECTIVE	We also evaluate the impact of each surgical technique in reduction of snoring loudness .
METHODS	Single blind randomized-controlled trial .
METHODS	From a population of 41 consecutive patients on the waiting list for uvulopalatoplasty for simple snoring , the study group was reduced to 17 CP and 13 LAUP .
METHODS	Post-operative pain and reduction of snoring loudness were recorded using visual analogue scales ( VAS ) during the first 15 post-operative days .
METHODS	Post-operative snoring loudness was documented for 1-year period .
RESULTS	Both groups had similar post-operative pain during the first seven post-operative days .
RESULTS	A statistically significant reduction in post-operative pain was observed in the CP group after day 8 , and maintained until the end of the study .
RESULTS	Reduction of snoring loudness was significant in both groups , but no differences were observed between them .
CONCLUSIONS	Coblation uvulopalatoplasty compared with LAUP demonstrates a reduction in post-operative pain , significant after the first post-operative week .
CONCLUSIONS	The collateral thermal injury caused by laser is responsible for the slow-healing rate and maintained post-operative pain .
CONCLUSIONS	Coblation dissociates tissue at lower temperatures with minimal collateral thermal injury and consequently faster and less painful recovery .
CONCLUSIONS	Both surgical procedures have significant and similar reduction in snoring loudness .
CONCLUSIONS	Both methods are adequate treatment options for snoring .
CONCLUSIONS	The less painful recovery in CP promotes this surgical technique as our preferred choice for palate surgery .

###23534542
BACKGROUND	The stability and propagation of hepatitis C virus ( HCV ) is dependent on a functional interaction between the HCV genome and liver-expressed microRNA-122 ( miR-122 ) .
BACKGROUND	Miravirsen is a locked nucleic acid-modified DNA phosphorothioate antisense oligonucleotide that sequesters mature miR-122 in a highly stable heteroduplex , thereby inhibiting its function .
METHODS	In this phase 2a study at seven international sites , we evaluated the safety and efficacy of miravirsen in 36 patients with chronic HCV genotype 1 infection .
METHODS	The patients were randomly assigned to receive five weekly subcutaneous injections of miravirsen at doses of 3 mg , 5 mg , or 7 mg per kilogram of body weight or placebo over a 29-day period .
METHODS	They were followed until 18 weeks after randomization .
RESULTS	Miravirsen resulted in a dose-dependent reduction in HCV RNA levels that endured beyond the end of active therapy .
RESULTS	In the miravirsen groups , the mean maximum reduction in HCV RNA level ( log10 IU per milliliter ) from baseline was 1.2 ( P = 0.01 ) for patients receiving 3 mg per kilogram , 2.9 ( P = 0.003 ) for those receiving 5 mg per kilogram , and 3.0 ( P = 0.002 ) for those receiving 7 mg per kilogram , as compared with a reduction of 0.4 in the placebo group .
RESULTS	During 14 weeks of follow-up after treatment , HCV RNA was not detected in one patient in the 5-mg group and in four patients in the 7-mg group .
RESULTS	We observed no dose-limiting adverse events and no escape mutations in the miR-122 binding sites of the HCV genome .
CONCLUSIONS	The use of miravirsen in patients with chronic HCV genotype 1 infection showed prolonged dose-dependent reductions in HCV RNA levels without evidence of viral resistance .
CONCLUSIONS	( Funded by Santaris Pharma ; ClinicalTrials.gov number , NCT01200420 . )

###24596968
BACKGROUND	Obesity is one of the greatest public health challenges world wide and its prevalence has increased during the past 20-30 years .
BACKGROUND	Obesity is related to physical and mental health and increased mortality .
BACKGROUND	There are few evidence-based treatment options for the obese available in Iceland .
METHODS	The purpose of this pilot study was to develop a 15 week group program based on Cognitive Behavior Therapy and Appetite Awareness Training for young obese women .
METHODS	The participants were randomly allocated to two groups , A and B , in a convenience sample of 20 women , aged 19-44 with a BMI 30-39 .9 kg/m .
METHODS	Group A attended the program while group B served as a control in a crossover design where group B subsequently participated in the program .
METHODS	The effectiveness of the program was evaluated before , during and at the end of the program and at six and twelve month follow-up .
METHODS	Information was collected on body weight , BMI , body fat and body fat mass , blood pressure , cholesterol , triglyceride , high density lipoprotein and 25 ( OH ) D , quality of life ( SF-36 and OP scale ) , symptoms of depression ( BDI-II ) and anxiety ( BAI ) .
METHODS	Additionally participants completed a questionnaire on demographics and their view on participating in the program was assessed .
RESULTS	Participants reduced their weight ( P = 0.001 ) , BMI ( P = 0.001 ) , body fat ( P = 0.010 ) , body fat mass ( P = 0.002 ) , diastolic blood pressure ( P = 0.005 ) and vitamin D status improved ( P = 0.008 ) .
RESULTS	Symptoms of depression and anxiety decreased ( P < 0.001 and P < 0.004 ) .
RESULTS	Quality of life measured with OP scale improved ( P = 0.006 ) and the mental component summary ( MCS ) ( P = 0.012 ) of the SF-36 scale .
RESULTS	The mean weight loss was 3.7 kg following intervention which was maintained at follow up .
CONCLUSIONS	`` The enjoy eating '' program is a promising health promotion approach in the health care sector for obese women to improve mental health , quality of life and loose weight .

###22879453
BACKGROUND	Chronic undernutrition is a common condition in older people with low socioeconomic status and is clearly an important component of frailty .
BACKGROUND	However , it is uncertain whether protein-energy supplementation can prevent functional decline in this group .
METHODS	Eighty-seven frail older adults ( usual gait speed , < 0.6 m/second ; Mini Nutritional Assessment , < 24 ) were enrolled in this randomized controlled trial .
METHODS	Participants were randomly assigned to either an intervention group , which was provided two 200-mL cans of commercial liquid formula ( additional 400 kcal of energy , 25g of protein , 9.4 g of essential amino acids , 400mL of water ) per day for 12 weeks , or the controls group , which did not receive this supplement .
METHODS	The primary outcomes were the change of the Physical Functioning and Short Physical Performance Battery .
METHODS	Usual gait speed , timed up-and-go test , hand grip strength , and one-legged stance were also measured as secondary outcome variables .
RESULTS	Physical Functioning increased by 5.9 % ( 1 point ) in the intervention group , although no change was observed in the control group ( p = .052 ) .
RESULTS	Short Physical Performance Battery remained stable in the intervention group , although it decreased by 12.5 % ( 1 point ) in controls ( p = .039 ) .
RESULTS	Usual gait speed decreased by 1.0 % in the intervention group versus 11.3 % ( 0.04 m/second ) in controls ( p = .039 ) .
RESULTS	Timed up-and-go improved by 7.2 % ( 1.1 seconds ) in the intervention group and worsened by 3.4 % ( 0.9 seconds ) in controls ( p = .038 ) .
RESULTS	There were no differences between groups in hand grip strength or one-legged stance performance .
CONCLUSIONS	The results indicate that protein-energy supplementation administered to frail older adults with low socioeconomic status shows evidence of reducing the progression of functional decline .

###19095163
BACKGROUND	Interactive technologies have the potential to increase the reach and frequency of practical clinical interventions that assist the parents of overweight and at-risk children to promote healthy lifestyle behaviors for their families .
METHODS	A practical RCT evaluated the relative effectiveness of three interventions to support parents of overweight or at-risk children to change the home environment to foster more healthful child eating and activity behaviors , thereby reducing child BMI and BMI z-scores .
METHODS	A secondary purpose was to determine the patterns of use and potential dose effect for the highest-intensity intervention .
METHODS	Parent-and-child ( aged 8-12 years ) dyads ( N = 220 ) who received care from Kaiser Permanente Colorado were assigned randomly to one of the three Family Connections ( FC ) interventions : FC-workbook , FC-group , or FC-interactive voice response ( IVR ) counseling .
METHODS	Child BMI z-scores , as well as symptoms of eating disorders and body image , were assessed at baseline , 6 months , and 12 months .
RESULTS	The BMI z-scores of children assigned to the FC-IVR intervention were the only ones that decreased from baseline to 6 months ( 0.07 SD ) and from baseline to 12 months ( 0.08 SD , p < 0.05 ) .
RESULTS	Children whose parents completed at least six of the ten FC-IVR counseling calls had decreased BMI z-scores to a greater extent than children in the FC-workbook or FC-group interventions at both 6 months ( p < 0.05 ) and 12 months ( p < 0.01 ) .
RESULTS	No intervention increased child symptoms of eating disorders or body dissatisfaction at any time point .
CONCLUSIONS	This trial demonstrated that automated telephone counseling can support the parents of overweight children to reduce the extent to which their children are overweight .
BACKGROUND	NCT00433901 .

###26216331
BACKGROUND	DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases .
METHODS	This multicenter , open-label , comparator-controlled , phase III study randomly assigned healthy infants 2-to-1 as follows : group 1 received DTaP5-IPV-Hib-HepB , PCV13 , and RV5 at 2 , 4 , and 6 months of age followed by DTaP5 , Hib-OMP , and PCV13 at 15 months of age ; group 2 received DTaP5-IPV/Hib , PCV13 , and RV5 at 2 , 4 , and 6 months of age , with HepB at 2 and 6 months of age , followed by DTaP5 , Hib-TT , and PCV13 at 15 months of age .
RESULTS	Overall , 981 participants were vaccinated in group 1 and 484 in group 2 .
RESULTS	Immune responses in group 1 to all antigens contained in DTaP5-IPV-Hib-HepB 1 month after dose 3 and for concomitant rotavirus vaccine were noninferior to those in group 2 , with the exception of antipertussis filamentous hemagglutinin ( FHA ) geometric mean concentrations ( GMCs ) .
RESULTS	Vaccine response rates for FHA were noninferior to control .
RESULTS	After the toddler dose , group 1 immune responses were noninferior to group 2 for all pertussis antigens .
RESULTS	Solicited adverse event rates after any dose were similar in both groups , with the exceptions of increased injection-site erythema , increased fever , and decreased appetite in group 1 .
RESULTS	Fever was not associated with hospitalization or seizures .
CONCLUSIONS	The safety and immunogenicity of DTaP5-IPV-Hib-HepB are comparable with the analogous licensed component vaccines .
CONCLUSIONS	Decreased FHA GMCs and increased injection-site reactions and fever are unlikely to be clinically significant .
CONCLUSIONS	DTaP5-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule .

###10976977
OBJECTIVE	To determine the clinical benefit of dextrose prolotherapy ( injection of growth factors or growth factor stimulators ) in osteoarthritic finger joints .
METHODS	Prospective randomized double-blind placebo-controlled trial .
METHODS	Outpatient physical medicine clinic .
METHODS	Six months of pain history was required in each joint studied as well as one of the following : grade 2 or 3 osteophyte , grade 2 or 3 joint narrowing , or grade 1 osteophyte plus grade 1 joint narrowing .
METHODS	Distal interphalangeal ( DIP ) , proximal interphalangeal ( PIP ) , and trapeziometacarpal ( thumb CMC ) joints were eligible .
METHODS	Thirteen patients ( with seventy-four symptomatic osteoarthitic joints ) received active treatment , and fourteen patients ( with seventy-six symptomatic osteoarthritic joints ) served as controls .
METHODS	One half milliliter ( 0.5 mL ) of either 10 % dextrose and 0.075 % xylocaine in bacteriostatic water ( active solution ) or 0.075 % xylocaine in bacteriostatic water ( control solution ) was injected on medial and lateral aspects of each affected joint .
METHODS	This was done at 0 , 2 , and 4 months with assessment at 6 months after first injection .
METHODS	One-hundred millimeter ( 100 mm ) Visual Analogue Scale ( VAS ) for pain at rest , pain with joint movement and pain with grip , and goniometrically-measured joint flexion .
RESULTS	Pain at rest and with grip improved more in the dextrose group but not significantly .
RESULTS	Improvement in pain with movement of fingers improved significantly more in the dextrose group ( 42 % versus 15 % with a p value of .027 ) .
RESULTS	Flexion range of motion improved more in the dextrose group ( p = .003 ) .
RESULTS	Side effects were minimal .
CONCLUSIONS	Dextrose prolotherapy was clinically effective and safe in the treatment of pain with joint movement and range limitation in osteoarthritic finger joints .

###23936893
BACKGROUND	Distraction has recently gained attention as a technique that may help reduce acute pain in infants and toddlers ; however , results remain equivocal .
BACKGROUND	It appears that these mixed results stem from a variety of methodological differences with regard to how distraction is implemented .
OBJECTIVE	To offer more definitive conclusions regarding the efficacy and mechanisms of distraction for pain management during infancy .
OBJECTIVE	Specifically , the goal was to examine whether the agent of distraction ( i.e. , the specific person conducting the distraction ) and preneedle distress behaviours impact the efficacy of distraction when toddlers were held by parents .
METHODS	A total of 99 toddlers were randomly assigned to one of three conditions ( typical care , research assistant-directed distraction or parent-directed distraction ) .
METHODS	Toddler distress behaviours were assessed pre - and postneedle .
METHODS	Toddlers were further grouped according to distress behaviours preneedle ( lowno distress versus high distress ) .
METHODS	Parental soothing behaviours were also assessed as a manipulation check .
RESULTS	Toddler postneedle pain did not significantly differ among groups .
RESULTS	However , toddlers who were distressed preneedle displayed significantly more pain postneedle , regardless of the treatment group .
RESULTS	There were no significant interactions between treatment group and preneedle distress behaviours .
CONCLUSIONS	These results suggest that , when being held by a parent , distraction using a toy does not result in lower pain scores in the context of immunization , regardless of who offers the distraction .
CONCLUSIONS	Furthermore , these findings raise the notion that if clinicians ensured toddlers were regulated before attempting an immunization , postneedle pain may be significantly reduced .

###12799509
OBJECTIVE	We conducted a study to determine whether administration of a pneumococcal conjugate vaccine to toddlers attending day-care centers ( DCCs ) could prevent acquisition of Streptococcus pneumoniae of the vaccine serotypes ( VT ) by their younger siblings .
METHODS	In a double blind study , 262 DCC attendees ages 12 to 35 months were randomized to receive a 9-valent pneumococcal conjugate vaccine ( PnCRM9 ; n = 132 ) , or a control vaccine ( meningococcus C vaccine ; n = 130 ) .
METHODS	It was planned to follow the groups for 2 years with monthly nasopharyngeal pneumococcal cultures during the first follow-up year and every 2 months during the second year .
METHODS	Forty-six younger siblings of the above described children , age < 18 months ( 23 siblings of the PnCRM9 recipients and 23 of the controls ) , were also enrolled , and nasopharyngeal cultures were obtained monthly until the children reached the age of 18 months or started to attend DCC , if before the age of 18 months .
METHODS	Pneumococcal isolates were serotyped and tested for antibiotic susceptibility .
RESULTS	Of the 3748 cultures obtained from the DCC attendees , 2450 ( 65 % ) were positive for S. pneumoniae .
RESULTS	Of 306 cultures obtained from the younger siblings , 151 ( 49 % ) were positive .
RESULTS	Among the PnCRM9 recipients , cultures were significantly less frequently positive for the VT S. pneumoniae than among the controls ( 13 % vs. 21 % , respectively ; P < 0.001 ) .
RESULTS	The same pattern was seen in the younger siblings of PnCRM9 recipients vs. the siblings of controls ( 21 % vs. 34 % , respectively ; P = 0.017 ) .
RESULTS	The reverse trend was seen for non-VT strains in both the DCC attendees ( 44 % vs. 34 % , respectively ; P < 0.001 ) and their younger siblings ( 19 % vs. 13 % , respectively ; P = 0.15 ) .
RESULTS	There was a significant decrease in the carriage rate of antibiotic-resistant S. pneumoniae in both the PnCRM9 recipients and their younger siblings .
RESULTS	The relative risks ( and 95 % confidence intervals ) to carry S. pneumoniae penicillin-nonsusceptible , resistant to > or = 1 , > or = 2 and > or = 3 antibiotic categories among younger siblings of PnCRM9 recipients vs. siblings of controls were 0.47 ( 0.31 to 0.70 ) , 0.49 ( 0.33 to 0.71 ) , 0.46 ( 0.30 to 0.73 ) and 0.49 ( 0.21 to 1.17 ) , respectively .
RESULTS	When acquired , VT and antibiotic-resistant S. pneumoniae were carried for a significantly shorter period of time among siblings of PnCRM9 recipients than in siblings of controls .
CONCLUSIONS	The marked effect of PnCRM9 administration to DCC attendees on carriage of VT and antibiotic-resistant S. pneumoniae among their younger household close contacts demonstrates a herd effect of the vaccine .

###9279624
BACKGROUND	Five randomized trials , a follow-up study , and six case-control investigations of BCG vaccine 's effectiveness ( VE ) for preventing leprosy have been conducted internationally , with widely varying estimates of VE .
BACKGROUND	Because of the difficulty of generalizing from disparate results , local estimates of VE are needed for health planning purposes and are currently particularly relevant , given the World Health Organization 's ( WHO ) goal to eliminate leprosy by the year 2000 .
METHODS	We conducted a case-control study in Yangon , Myanmar .
METHODS	Residents of Yangon between the ages of 6 years and 24 years who were listed in the National Leprosy Registry as being on active treatment for leprosy between December 1992 and April 1993 were eligible to participate in the study as cases .
METHODS	Control subjects were matched to the cases on age , sex , and neighbourhood .
RESULTS	One or more doses of BCG were associated with a VE of 66 % .
RESULTS	The results show a significant trend of increasing VE with increasing number of BCG doses ( one dose , VE = 55 % ; two doses , VE = 68 % ; three doses , VE = 87 % ) .
RESULTS	One dose of BCG vaccine appeared to provide protection substantially higher than that found in an earlier vaccine trial in Myanmar , but consistent with results from case-control studies in other countries .
CONCLUSIONS	These data suggest that BCG reduces the risk of leprosy in Myanmar , and that BCG vaccination of infants , along with early case-finding and treatment , should be considered an important part of the leprosy intervention strategy .

###18056186
OBJECTIVE	In the first years of imatinib treatment , BCR-ABL remained detectable in all but a small minority of patients with chronic myeloid leukemia .
OBJECTIVE	We determined whether BCR-ABL continues to decline with longer imatinib exposure and the incidence and consequence of undetectable BCR-ABL .
METHODS	BCR-ABL levels were measured in a subset of 53 imatinib-treated IRIS trial patients for up to 7 years ( 29 first-line , 24 second-line ) .
METHODS	Levels were deemed undetectable using strict PCR sensitivity criteria .
RESULTS	By 18 months , the majority achieved a 3-log reduction [ major molecular response ( MMR ) ] .
RESULTS	BCR-ABL continued to decline but at a slower rate ( median time to 4-log reduction and undetectable BCR-ABL of 45 and 66 months for first-line ) .
RESULTS	The probability of undetectable BCR-ABL increased considerably from 36 to 81 months of first-line imatinib { 7 % [ 95 % confidence interval ( 95 % CI ) , 0-17 % ] versus 52 % ( 95 % CI , 32-72 % ) } .
RESULTS	Undetectable BCR-ABL was achieved in 18 of 53 patients and none of these 18 lost MMR after a median follow-up of 33 months .
RESULTS	Conversely , MMR was lost in 6 of 22 ( 27 % ) patients with sustained detectable BCR-ABL and was associated with BCR-ABL mutations in 3 of 6 .
RESULTS	Loss of MMR was recently defined as suboptimal imatinib response .
RESULTS	There was no difference in the probability of achieving molecular responses between first - and second-line patients but first-line had a significantly higher probability of maintaining MMR [ P = 0.03 ; 96 % ( 95 % CI , 88-100 % ) versus 71 % ( 95 % CI , 48-93 % ) ] .
CONCLUSIONS	With prolonged therapy , BCR-ABL continued to decline in most patients and undetectable BCR-ABL was no longer a rare event .
CONCLUSIONS	Loss of MMR was only observed in patients with sustained detectable BCR-ABL .

###9160033
OBJECTIVE	The purpose of the study is to evaluate in a double-blind , randomized study the efficacy of lodoxamide tromethamine 0.1 % versus placebo .
METHODS	Signs and symptoms , tear tryptase , and tear fluid cytology were evaluated in 20 asymptomatic subjects with allergic conjunctivitis .
METHODS	The study included three allergen challenges in skin test-positive patients .
METHODS	At the first visit , a threshold dose of allergen was established .
METHODS	At the second visit , a bilateral ocular challenge was performed without pretreatment .
METHODS	At the third visit , either lodoxamide or placebo eye drops were used for 1 week before ocular challenge .
RESULTS	Lodoxamide significantly reduced tryptase levels ( P < 0.01 ) , neutrophils ( P < 0.04 ) , and eosinophils ( P < 0.01 ) in the tear fluid and significantly inhibited ocular itching ( P < 0.02 ) when compared with that of placebo .
CONCLUSIONS	Lodoxamide is effective in reducing tryptase levels and the recruitment of inflammatory cells in the tear fluid after allergen challenge .

###14579879
OBJECTIVE	To evaluate the 2-year clinical sealant success when using Prompt L-Pop ( 3M-ESPE ) , the first self-etching adhesive , as the sole etching and adhesive step prior to sealant placement .
METHODS	Patients ages 7-13 years with matched pairs of permanent molars needing sealants were enrolled into an ongoing clinical study of sealant success .
METHODS	First and/or second permanent molars were randomly assigned to control ( sealant only after phosphoric acid etch ) or Prompt plus sealant groups in a split-mouth , matched pair study design .
METHODS	Standard methods were used for sealant ( Delton , Dentsply ) placement , except for the Prompt group in which the self-etching adhesive was brushed on the surface , air thinned , followed by immediate placement of the sealant and polymerization .
METHODS	All sealants were placed using appropriate cotton-roll isolation and a dental assistant .
METHODS	Sealant scoring was done at 24 months using strict clinical criteria for failure , previously published , and photos of the sealed surfaces were archived on video .
RESULTS	Percentages of sealants scored as successful ( no significant loss of material or need for repair ) through 24 months were : ( a ) Occlusal sealants : Control = 61 % , versus Prompt = 61 % ; ( b ) Bu/Lingual sealants : Control = 54 % , versus Prompt = 62 % ; McNemar 's Chi Square tests indicate no difference in success between the Prompt sealants and their matched controls ( P > 0.80 ) .
RESULTS	Time of placement for sealants , timed from start of the etch step through polymerization , averaged 3.1 minutes for Control and 1.8 minutes for Prompt .
RESULTS	We conclude that Prompt L-Pop self-etching adhesive is effective in bonding sealant to enamel and that the simplified method dramatically shortens treatment time and treatment complexity .

###15987228
OBJECTIVE	To compare the costs and effectiveness of adjustable maintenance dosing with budesonide/formoterol in a single inhaler versus fixed dosing in adults with asthma .
METHODS	In this prospective , randomised , open-label , parallel-group , multicentre trial conducted in Germany , patients with asthma received budesonide/formoterol 160 microg/4 .5 microg in a single inhaler ( Symbicort Turbuhaler with two inhalations twice daily for a 4-week run-in period .
METHODS	Patients were then randomised to either adjustable maintenance dosing ( one inhalation twice daily , stepping up to four inhalations twice daily for 1 week if asthma worsened ; n = 1679 ) or fixed dosing ( two inhalations twice daily ; n = 1618 ) for 12 weeks .
METHODS	The primary efficacy variable was the change in health-related quality of life ( HR-QOL ) , measured using the Asthma Quality of Life Questionnaire ( standardised ) during the randomised treatment period .
METHODS	Resource utilisation data were collected in parallel and combined with German unit costs to estimate direct and indirect costs ( year 2001 values ) .
RESULTS	Both treatment regimens were equally effective in maintaining HR-QOL and asthma control during the randomised treatment period .
RESULTS	However , overall , patients in the adjustable maintenance dosing group took fewer daily inhalations of budesonide/formoterol than those in the fixed-dosing group ( mean : 2.63 vs 3.82 inhalations ; p < 0.001 ) .
RESULTS	Adjustable maintenance dosing was associated with significantly lower asthma-related direct costs compared with fixed dosing ( mean : 221 euro vs 292 euro ; p < 0.001 ) .
RESULTS	This pattern was maintained when patients were stratified into those with peak expiratory flow ( PEF ) of 60 % to < 80 % predicted normal and those with PEF of > / = 80 % predicted normal and when total costs were considered .
CONCLUSIONS	Adjustable maintenance dosing with budesonide/formoterol in a single inhaler maintained HR-QOL in adult patients with asthma at a significantly lower cost than fixed dosing .

###16969378
OBJECTIVE	To compare the individual effects of dietary alpha-linolenic acid ( ALA ) , eicosapentaenoic acid ( EPA ) or docosahexaenoic acid ( DHA ) on low-density lipoprotein ( LDL ) fatty acid composition , ex vivo LDL oxidizability and tocopherol requirement .
METHODS	A randomized strictly controlled dietary study with three dietary groups and a parallel design , consisting of two consecutive periods .
METHODS	Sixty-one healthy young volunteers , students at a nearby college , were included .
METHODS	Forty-eight subjects ( 13 males , 35 females ) completed the study .
METHODS	Subjects received a 2-week wash-in diet rich in monounsaturated fatty acids ( 21 % energy ) followed by experimental diets enriched with about 1 % of energy of ALA , EPA or DHA for 3 weeks .
METHODS	The omega-3 ( n-3 ) fatty acids were provided with special rapeseed oils and margarines .
METHODS	The wash-in diet and the experimental diets were identical , apart from the n-3 fatty acid composition and the tocopherol content , which was adjusted to the content of dienoic acid equivalents .
RESULTS	Ex vivo oxidative susceptibility of LDL was highest after the DHA diet , indicated by a decrease in lag time ( -16 % , P < 0.001 ) and an increase in the maximum amount of conjugated dienes ( +7 % , P < 0.001 ) .
RESULTS	The EPA diet decreased the lag time ( -16 % , P < 0.001 ) and the propagation rate ( -12 % , P < 0.01 ) .
RESULTS	Tocopherol concentrations in LDL decreased in the ALA group ( -13.5 % , P < 0.05 ) and DHA group ( -7.3 % , P < 0.05 ) .
RESULTS	Plasma contents of tocopherol equivalents significantly decreased in all three experimental groups ( ALA group : -5.0 % , EPA group : -5.7 % , DHA group : -12.8 % ) .
RESULTS	The content of the three n-3 polyunsaturated fatty acid differently increased in the LDL : on the ALA diet , the ALA content increased by 89 % ( P < 0.001 ) , on the EPA diet the EPA content increased by 809 % ( P < 0.001 ) and on the DHA diet , the DHA content increased by 200 % ( P < 0.001 ) .
RESULTS	In addition , the EPA content also enhanced ( without dietary intake ) in the ALA group ( +35 % , P < 0.01 ) and in the DHA group ( +284 % , P < 0.001 ) .
CONCLUSIONS	Dietary intake of ALA , EPA or DHA led to a significant enrichment of the respective fatty acid in the LDL particles , with dietary EPA preferentially incorporated .
CONCLUSIONS	In the context of a monounsaturated fatty acid-rich diet , ALA enrichment did not enhance LDL oxidizability , whereas the effects of EPA and DHA on ex vivo LDL oxidation were inconsistent , possibly in part due to further changes in LDL fatty acid composition .

###10913939
OBJECTIVE	Our aim has been to evaluate the effects of i.v. infusion of recombinant human erythropoietin ( rhEPO ) on the responses of growth hormone ( GH ) , prolactin ( PRL ) and thyrotropin ( TSH ) to thyrotropin-releasing hormone ( TRH ) stimulation in acromegalic patients .
METHODS	We studied 16 patients ( 8 females , aged 29-68 years ) with active acromegaly and 12 control subjects ( 7 females , 24-65 years ) .
METHODS	All participants were tested with TRH ( 400 microg i.v. as bolus ) and with TRH plus rhEPO ( 40 U/kg at a constant infusion rate for 30 min , starting 15 min before TRH injection ) on different days .
METHODS	Blood samples were obtained between -30 and 120 min for GH and PRL determinations , and between -30 and 90 min for TSH determinations .
METHODS	Hormone responses were studied by a time-averaged ( area under the secretory curve ( AUC ) ) and time-independent ( peak values ) analysis .
RESULTS	Twelve patients exhibited a paradoxical GH reaction after TRH administration with great interindividual variability in GH levels .
RESULTS	When patients were stimulated with rhEPO plus TRH there were no changes in the variability of GH responses or in the peak and AUC for GH secretion .
RESULTS	Infusion with rhEPO did not induce any significant change in GH secretion in normal subjects .
RESULTS	Baseline and TRH-stimulated PRL concentrations in patients did not differ from those values found in controls .
RESULTS	When TRH was injected during the rhEPO infusion , a significant ( P < 0.05 ) increase in PRL concentrations at 15-120 min was found in acromegalic patients .
RESULTS	Accordingly , the PRL peak and the AUC for PRL secretion were significantly increased in patients .
RESULTS	Infusion with rhEPO had no effect on TRH-induced PRL release in control subjects .
RESULTS	Baseline TSH concentrations , as well as the TSH peak and the AUC after TRH , were significantly lower in patients than in controls .
RESULTS	Infusion with rhEPO modified neither the peak TSH reached nor the AUC for TSH secretion after TRH injection in acromegalic patients and in healthy volunteers .
CONCLUSIONS	Results in patients with acromegaly suggest that ( i ) the paradoxical GH response to TRH is not modified by rhEPO infusion , ( ii ) rhEPO has no effect on TRH-induced TSH release , and ( iii ) acute rhEPO administration increases the TRH-induced PRL release in acromegalic patients .

###24626433
OBJECTIVE	Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear .
METHODS	The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo .
METHODS	This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access .
RESULTS	Among 2353 SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a 13 % proportional reduction in vascular access occlusive events ( 355 [ 29.7 % ] for simvastatin/ezetimibe versus 388 [ 33.5 % ] for placebo ; risk ratio [ RR ] , 0.87 ; 95 % confidence interval [ 95 % CI ] , 0.75 to 1.00 ; P = 0.05 ) .
RESULTS	There was no evidence that the effects of treatment differed for any of the separate components of this outcome .
RESULTS	To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort .
RESULTS	AURORA did not provide independent confirmation ( vascular access occlusive events : 352 [ 28.9 % ] for rosuvastatin versus 337 [ 27.6 % ] for placebo ; RR , 1.06 , 95 % CI , 0.91 to 1.23 ; P = 0.44 ) .
RESULTS	After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( 707 [ 29.3 % ] with any LDL-C-lowering therapy versus 725 [ 30.5 % ] with placebo ; RR , 0.95 , 95 % CI , 0.85 to 1.05 ; P = 0.29 ) .
CONCLUSIONS	Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA .
CONCLUSIONS	Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .

###24966134
BACKGROUND	This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life ( HRQoL ; the primary outcome ) , physical activity ( PA ) , and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings .
METHODS	The study was a cluster-randomized controlled trial .
METHODS	Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria ; one of each pair was randomly assigned to the intervention or control condition .
METHODS	Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year ( 2011 ) .
METHODS	Female students in grades 7-9 in intervention schools participated in two 6-session PA units - a sport unit ( football or tennis ) and a recreational unit ( leisure centre-based ) .
METHODS	These were incorporated into physical education ( PE ) curriculum and linked to PA opportunities for participation outside school .
METHODS	Students were surveyed at baseline and endpoint , self-reporting impact on primary and secondary outcome measures ( HRQoL , PA ) and PA mediators ( e.g. self-efficacy ) .
METHODS	Linear mixed models for two-group ( intervention , control ) and three-group ( completers , non-completers , control ) analyses were conducted with baseline value , age and BMI as covariates , group as a fixed effect and school as random cluster effect .
RESULTS	Participants completing baseline and endpoint measures included : 358 intervention ( baseline response rate 33.7 % , retention rate 61.3 % ) and 256 control ( 14.1 % and 84.0 % ) .
RESULTS	Adjustment for age and BMI made no substantive difference to outcomes , and there were no cluster effects .
RESULTS	For HRQoL , after adjustment for baseline scores , the intervention group showed significantly higher scores on all three PedsQL scores ( physical functioning : MSE = 83.90.7 , p = .005 ; psychosocial : 79.90.8 , p = .001 ; total score : 81.30.7 , p = .001 ) than the control group ( 80.90.8 ; 76.10.9 and 77.80.8 ) .
RESULTS	The three-group analysis found intervention non-completers had significantly higher PedsQL scores ( 84.00.8 , p = .021 ; 80.40.9 , p = .003 ; 81.70.8 , p = .002 ;) than controls ( 80.90.8 , 76.10.9 and 77.80.8 ) .
RESULTS	There were no significant differences for any PA measure .
RESULTS	Intervention completers had significantly higher scores than non-completers and controls for some mediator variables ( e.g. self-efficacy , behavioural control ) .
CONCLUSIONS	Positive outcomes were achieved from a modest school-community linked intervention .
CONCLUSIONS	The school component contributed to maintaining HRQoL ; students who completed the community component derived a range of intra-personal and inter-personal benefits .
BACKGROUND	ACTRN12614000446662 .
BACKGROUND	April 30th 2014 .

###20970833
OBJECTIVE	This study used pooled data from 2 large , phase III , double-blind , randomized , placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release ( XR ) in men with overactive bladder ( OAB ) .
METHODS	A subgroup analysis was performed on data from the 176 male patients ( trospium XR , 94 ; placebo , 82 ) who participated in 1 of the 2 studies .
METHODS	Patients received either trospium XR 60 mg or placebo once daily for 12 weeks .
RESULTS	The mean age was 66.2 years for trospium XR and 63.1 years for placebo .
RESULTS	A history of benign prostatic hyperplasia was recorded for 29 trospium XR recipients ( 30.9 % ) and 23 placebo recipients ( 28.0 % ) .
RESULTS	A total of 19 patients ( 20.2 % ) receiving trospium XR and 15 ( 18.3 % ) receiving placebo experienced 1 treatment-emergent adverse event considered at least possibly related to the study medication .
RESULTS	Two trospium XR patients ( 2.1 % ) developed urinary retention ; both were aged 75 years , and 1 had a history of prostate enlargement .
RESULTS	Treatment with trospium XR compared with placebo resulted in significantly greater decreases from baseline in the mean number of daily toilet voids ( -2.5 vs -1.5 ; P < .05 ) and urgency urinary incontinence episodes ( -2.3 vs -1.4 ; P < .05 ) in men at week 12 ( the coprimary efficacy variables ) .
CONCLUSIONS	Trospium XR is safe and effective in men with OAB .
CONCLUSIONS	The risk of urinary retention is low and may be further decreased by careful patient selection .

###9454524
BACKGROUND	Uncertainty exists about the suitability of oral hypoglycemic drugs and insulin therapy for patients with newly diagnosed type 2 diabetes .
OBJECTIVE	To assess and compare response to sulfonylurea , insulin , or metformin over 6 years in patients with newly diagnosed type 2 diabetes in whom disease could and could not be controlled with diet therapy alone .
METHODS	Multicenter , randomized , controlled trial .
METHODS	Outpatient diabetes clinics of 15 hospitals in the United Kingdom .
METHODS	Sulfonylurea ( chlorpropamide or glyburide ) , insulin , or metformin ( if patients were obese ) .
METHODS	458 patients with newly diagnosed type 2 diabetes that could not be controlled with diet and had hyperglycemic symptoms or fasting plasma glucose levels greater than 15 mmol/L during the initial 3 months of diet therapy ( primary diet failure group ) and 1620 patients in whom disease was controlled by diet therapy and who had fasting plasma glucose levels of 6 to 15 mmol/L and no hyperglycemic symptoms while receiving diet therapy alone .
METHODS	Fasting plasma levels of glucose and insulin , hemoglobin A1c concentrations , body weight , and therapy required .
RESULTS	Compared with the diet-controlled group , the primary diet failure group was younger and less obese and had more retinopathy , lower fasting plasma insulin levels , and reduced beta-cell function .
RESULTS	At 6 years , patients allocated to insulin had lower fasting plasma glucose levels than did patients allocated to oral agents , but hemoglobin A1c concentrations were similar .
RESULTS	Forty-eight percent ( 95 % CI , 37 % to 58 % ) of patients in the primary diet failure group maintained hemoglobin A1c concentrations less than 0.08 .
RESULTS	By 6 years , 51 % of patients ( CI , 42 % to 62 % ) allocated to ultralente insulin required additional short-acting insulin and 66 % of patients ( CI , 58 % to 73 % ) allocated to sulfonylurea required additional therapy with metformin or insulin to control symptoms and maintain fasting plasma glucose levels less than 15 mmol/L .
RESULTS	Patients allocated to insulin gained more weight and had more hypoglycemic attacks than did patients allocated to sulfonylurea .
RESULTS	Obese patients allocated to metformin gained the least weight and had the fewest hypoglycemic attacks .
RESULTS	For all therapies , control achieved at 6 years was worse in the primary diet failure group than in the diet-controlled group .
CONCLUSIONS	Because initial insulin therapy induced more hypoglycemic reactions and weight gain without necessarily providing better control , it may be reasonable to start with oral agents and change to insulin if goals for glycemic levels are not achieved .

###24819857
OBJECTIVE	To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve ( AGV ) surgery outcomes .
METHODS	Randomized clinical trial .
METHODS	Ninety-four eyes of 94 patients with refractory glaucoma .
METHODS	After AGV implantation , 47 cases ( group 1 ) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure ( IOP ) exceeded 10 mmHg , whereas 47 controls ( group 2 ) received conventional stepwise treatment when IOP exceeded target pressure .
METHODS	Main outcome measures included IOP and success rate ( 6 mmHg < IOP < 15 mmHg and IOP reduction of at least 30 % from baseline ) .
METHODS	Other outcome measures included best-corrected visual acuity , complications , and hypertensive phase frequency .
RESULTS	Groups 1 and 2 were both followed up for a mean of 4511.6 and 47.27.4 weeks , respectively ( P = 0.74 ) .
RESULTS	Mixed model analysis revealed a significantly greater IOP reduction in group 1 at all intervals ( P < 0.001 ) .
RESULTS	At 1 year , the cases exhibited a significantly higher success rate ( 63.2 % vs. 33.3 % ; P = 0.008 ) and reduced hypertensive phase frequency ( 23.4 % vs. 66.0 % ; P < 0.001 ) .
CONCLUSIONS	Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction , success rate , and hypertensive phase frequency .

###20542419
OBJECTIVE	To compare the topical and the pulpal anesthesia efficacy of liposomal and plain benzocaine formulations .
METHODS	Double-blinded , randomized crossover study .
METHODS	University ambulatory dental center .
METHODS	30 ASA physical status I volunteers .
METHODS	Volunteers received , in three different sessions , topical application of liposome-encapsulated 10 % benzocaine ( LB10 ) , 10 % benzocaine gel ( B10 ) , and 20 % benzocaine gel ( B20 ) in the right maxillary canine mucobuccal fold .
METHODS	Pain associated with the needle insertion was rated by visual analog scale ( VAS ) and the duration of topical anesthesia was recorded .
METHODS	Pulpal anesthesia was evaluated using an electric pulp tester .
RESULTS	VAS values ( median , 1st - 3rd quartiles ) were 17 cm ( 11 - 25 ) , 14 cm ( 3 - 22 ) , and 21 cm ( 9 - 21 ) for B10 , LB10 , and B20 , respectively .
RESULTS	No differences were noted among the groups ( Friedman test ; P = 0.58 ) .
RESULTS	Soft tissue anesthesia was also not different .
RESULTS	The LB10 [ 10 ( 8 - 12 ) min ] showed longer soft tissue anesthesia ( Friedman test ; P < 0.01 ) than the other agents [ B10 = 8 ( 5 - 10 ) min , and B20 = 7 ( 6 - 9 ) min ] .
RESULTS	None of the topical benzocaine formulations tested induced pulpal anesthesia .
CONCLUSIONS	The encapsulation of benzocaine into liposome increased the duration of soft tissue anesthesia .
CONCLUSIONS	However , it did not induce pulpal anesthesia .

###12889683
BACKGROUND	The aim of this study was to test the hypothesis that people with a strong sense of coherence ( SOC ) have decreased all-cause mortality .
METHODS	The effect of occupation and the SOC on all-cause mortality was studied among 4405 Finnish middle-aged employed men in a prospective 8-year follow-up study .
RESULTS	Using Cox proportional hazards models the crude relative risk for all-cause mortality for the low SOC tertile when compared to the high SOC tertile was 1.23 ( 95 % CI : 0.90-1 .68 ) .
RESULTS	Adjusting for age , smoking , alcohol and occupation increased the risk slightly to 1.35 .
RESULTS	Occupation was an effect modifier , since among white-collar workers the corresponding relative risk of the low SOC tertile was 2.27 ( 95 % CI : 1.12-4 .59 , p = 0.02 ) and among blue-collar workers the relative risk for all-cause mortality was stable ( 1.33-1 .52 ) in each SOC tertile .
RESULTS	The classic risk factors , smoking and alcohol , showed higher relative risks than the SOC .
CONCLUSIONS	The effect of the health-promoting qualities of the SOC upon all-cause mortality was significant among white-collar workers , but not among blue-collar workers .

###10084467
OBJECTIVE	One week of regular treatment with salmeterol can induce tolerance to the protective effect of a beta2-agonist on early airway response to allergen ( EAR ) .
OBJECTIVE	The objective was to assess whether inhaled corticosteroids revert tolerance to salmeterol .
METHODS	The study had a randomized , double-blind , placebo-controlled design .
METHODS	Twelve subjects with mild allergic asthma and positive result of specific bronchial provocation test ( sBPT ) to allergen underwent three sBPTs , separated by 1 week .
METHODS	sBPT was done in all subjects after a single dose ( T1 ) and after 1 week of regular treatment with inhaled salmeterol ( 50 microg bid ) ( T2 ) in order to induce tolerance .
METHODS	Subjects were then randomized to receive either the same dose of salmeterol + beclomethasone dipropionate ( BDP , 500 microg bid ) ( group 1 , n = 6 ) or placebo + BDP ( group 2 , n = 6 ) for 1 week before sBPT ( T3 ) .
RESULTS	After a single dose of salmeterol ( T1 ) , all subjects were protected against EAR , whereas after 1 week of regular treatment , the protective effect of salmeterol was totally or partially lost ( T2 ) .
RESULTS	Maximum FEV1 percent fall ( MaxdeltaFEV1 % ) after allergen inhalation was significantly higher at T2 than at T1 .
RESULTS	All subjects except one of group 1 were protected against EAR after salmeterol + BDP ( T3 ) , and MaxdeltaFEV1 % at T3 ( median , 12 % ; range , 4 to 6 % ) was significantly lower than T2 ( median , 22 % ; range , 12 to 43 % ; p < 0.05 by Wilcoxon test ) .
RESULTS	Subjects of group 2 did not show any significant protection against EAR after placebo + BDP treatment ( T3 ) MaxdeltaFEV1 % at T2 ( median , 31 % ; range , 9 to 40 % ) and T3 ( median , 31 % ; range , 3 to 42 % ; not significant ) .
CONCLUSIONS	In conclusion , the addition of inhaled BDP partially restored the bronchoprotective effect of salmeterol on allergen challenge that was lost after 1 week of regular treatment with salmeterol alone .
CONCLUSIONS	This ability of BDP in reverting tolerance can not be ascribed to a direct effect of corticosteroids per se on allergen challenge in this group of asthmatics .

###24035872
OBJECTIVE	massage can help relieve pain , although empirical evidence is scarce and contradictory .
OBJECTIVE	This study aims to assess the effectiveness of a massage protocol in relieving pain in children hospitalized with cancer .
METHODS	a randomized , controlled , and single-blind trial was performed in a sample of 52 children aged between 10 and 18 years who were hospitalized in a pediatric cancer ward .
METHODS	The intervention consisted of the implementation of a massage protocol with three sessions of 20 to 30minutes on alternate days over a one-week period .
METHODS	The effectiveness of the protocol was evaluated by assessing pain using the Brief Pain Inventory ( BPI ) , while the effectiveness of each massage session was measured using the Visual Analogue Scale ( VAS ) .
RESULTS	the massage protocol was only effective in reducing the interference of pain in walking ( p < 0.05 ) , although it also contributed to relieve pain and its impact on the children 's activities .
RESULTS	After each massage session , the intensity of the pain experienced by the child decreased ( p < 0.001 ) .
CONCLUSIONS	despite the small sample size , massage therapy appears to be a useful intervention in reducing pain in children with cancer .
CONCLUSIONS	However , there are still questions regarding the effectiveness of this massage protocol .
CONCLUSIONS	The authors recommend its use due to its contribution to the promotion of the child 's well-being and quality of life .

###22379116
OBJECTIVE	To clarify the metabolic effects of an overnight i.v. infusion of unacylated ghrelin ( UAG ) in humans .
OBJECTIVE	UAG exerts relevant metabolic actions , likely mediated by a still unknown ghrelin receptor subtype , including effects on - cell viability and function , insulin secretion and sensitivity , and glucose and lipid metabolism .
METHODS	We studied the effects of a 16-h infusion ( from 2100 to 1300 h ) of UAG ( 1.0 g/kg per h ) or saline in eight normal subjects ( age ( means.e.m . )
METHODS	, 29.62.4 years ; body mass index ( BMI ) , 22.41.7 kg/m ( 2 ) ) , who were served , at 2100 and 0800 h respectively , with isocaloric balanced dinner and breakfast .
METHODS	Glucose , insulin , and free fatty acid ( FFA ) levels were measured every 20 min .
RESULTS	In comparison with saline , UAG induced significant ( P < 0.05 ) changes in glucose , insulin , and FFA profiles .
RESULTS	UAG infusion decreased glucose area under the curve ( AUC ) values by 10 % ( UAG ( 0 - 960 min ) : 79.01.710 ( 3 ) mg/dl per min vs saline ( 0 - 960 min ) : 87.53.810 ( 3 ) mg/dl per min ) and the AUC at night by 14 % ( UAG ( 180 ) ( - ) ( 660 min ) : 28.40.510 ( 3 ) mg/dl per min vs saline ( 180 - 660 min ) : 33.21.110 ( 3 ) mg/dl per min ) .
RESULTS	The overall insulin AUC was not significantly modified by UAG infusion ; however , insulin AUC observed after meals was significantly increased under the exposure to UAG with respect to saline at either dinner or breakfast .
RESULTS	The FFA AUC values were decreased by 52 % under the exposure to UAG in comparison with saline ( UAG ( 0 - 960 min ) : 0.30.0210 ( 3 ) mEq/l per min vs saline ( 0 - 960 min ) : 0.60.0510 ( 3 ) mEq/l per min ) .
CONCLUSIONS	Exposure to the i.v. administration of UAG improves glucose metabolism and inhibits lipolysis in healthy volunteers .
CONCLUSIONS	Thus , in contrast to the diabetogenic action of AG , UAG displays hypoglycemic properties .

###23228201
OBJECTIVE	There is no robust proof that the efficacy of lithium in the prevention of manic and depressive episodes in bipolar disorder depends on its plasma level .
OBJECTIVE	This analysis aimed to compare the effect of lithium within the presumed therapeutic range of 0.6-1 .2 mEq/L and below 0.6 mEq/L with that of placebo .
METHODS	We carried out a post hoc analysis of a double-blind trial in which patients aged 18 years with bipolar I disorder ( DSM-IV ) who had achieved stabilization from a manic , depressive , or mixed episode during open-label treatment with quetiapine were randomized to continue quetiapine or to switch to lithium or placebo for up to 104 weeks .
METHODS	Of patients randomized to lithium , 201 obtained median lithium levels between 0.6 and 1.2 mEq/L , and 137 obtained median lithium levels < 0.6 mEq/L .
METHODS	Their outcomes were compared with those of patients receiving placebo ( n = 404 ) .
METHODS	The primary outcome was time to recurrence of any mood event ; additional outcomes included time to recurrence of a manic or depressive event .
RESULTS	Times to recurrence of any mood event as well as a manic or depressive event were significantly longer for the lithium 0.6-1 .2 mEq/L group versus placebo and versus lithium < 0.6 mEq/L , with no differences between lithium < 0.6 mEq/L and placebo .
CONCLUSIONS	The results support and expand previous findings that lithium should be dosed high enough to achieve plasma levels 0.6 mEq/L in order to achieve an effect in the prevention of both manic and depressive recurrences of bipolar I disorder .
CONCLUSIONS	A major limitation is that the composition of the two lithium groups was not based on randomization .

###8605790
OBJECTIVE	To determine whether a continuous intravenous infusion of pentoxifylline , a methylxanthine derivative , alters the serum cytokine concentrations and/or hemodynamic measurements in patients with septic shock .
METHODS	A prospective , randomized , double-blind , placebo-controlled study .
METHODS	Medical intensive care unit in a university hospital .
METHODS	Sixteen patients with septic shock .
METHODS	Patients were randomly assigned to receive either pentoxifylline ( 1 mg/kg ) followed by an infusion of 1.5 mg/kg/hr for 24 hrs ( n = 8 ) , or placebo ( n = 8 ) .
RESULTS	Tumor necrosis factor ( TNF ) and interleukin ( IL ) -6 concentrations were measured by radioimmunoassays ; IL-8 concentrations by an enzyme-linked immunosorbent assay ( ELISA ) and pentoxifylline concentrations by high-performance liquid chromatography at 0 , 3 , 6 , 12 , 18 , 24 and 48 hrs after study entry .
RESULTS	Pulmonary artery catheter-derived hemodynamics were measured at 0 , 0.75 , 3 , 6 , 12 , 18 , and 24 hrs .
RESULTS	In pentoxifylline-treated patients , at 24 hrs , serum concentrations of TNF were significantly lower compared with controls ( 12 + / - 2 vs. 42 + / - 12 pg/mL , respectively , p = .04 ) .
RESULTS	Serum concentrations of IL-6 and IL-8 did not differ between the two treatment groups .
RESULTS	There were also no significant differences in any hemodynamic and oxygenation measurements comparing the two treatment groups .
RESULTS	Pentoxifylline concentrations were 1,544 + / - 241 ng/mL after the initial dose , and 5,776 + / - 1,781 ng/mL at the end of the 24-hr infusion .
RESULTS	Five patients in the pentoxifylline group and four patients in the placebo group died .
CONCLUSIONS	Pentoxifylline is able to decrease serum TNF but not IL-6 or IL-8 serum concentrations during septic shock .
CONCLUSIONS	Pentoxifylline was well tolerated by all eight patients with no adverse effect .
CONCLUSIONS	Further studies are needed to determine if pentoxifylline 's ability to lower circulating TNF concentration without altering hemodynamics will improve outcome in septic shock .

###11296170
OBJECTIVE	To investigate the interrelationship of free radicals ( FRs ) , ischemic preconditioning ( IP ) , and hemodynamic function in coronary artery bypass graft ( CABG ) patients .
METHODS	Prospective , randomized , and controlled clinical study .
METHODS	Forty CABG patients were randomized into an IP group ( n = 20 ) and a control group ( n = 20 ) .
METHODS	The IP group was preconditioned with two cycles of two-min ischemia followed by 3-min reperfusion before cross-clamping .
RESULTS	FR content in coronary sinus blood was measured directly using alpha-phenyl-N-tert-butylnitrone-electron spin-trapped spectroscopy .
RESULTS	A small amount of FRs was generated after the IP protocol ( 5.6 % above the baseline ) but not in control subjects .
RESULTS	A larger amount was generated 10 min after declamping in both groups ( 8.4 % in IP protocol and 7.7 % in control subjects ) .
RESULTS	Hemodynamic function recovered better in the IP group at 1 h and 6 h after declamping .
RESULTS	There was a significant negative correlation between FR generation after declamping and left ventricular stroke work index ( LVSWI ) at 1 h and 6 h after declamping ( r = -0.71 and - 0.59 , respectively ) in the control subjects but not in the IP group .
RESULTS	There was a significant positive correlation between FR generation after the IP protocol and cardiac index at 1 h and 6 h ( r = 0.50 and 0.61 , respectively ) and LVSWI at 1 h and 6 h ( r = 0.56 and 0.54 , respectively ) after declamping in the IP group but not in the control subjects .
CONCLUSIONS	FR generation after the operation correlates with ventricular functional depression in CABG patients .
CONCLUSIONS	IP protects the stunning heart but does not alter FR generation .
CONCLUSIONS	The association of better hemodynamic recovery after CABG with FR generation during the IP period suggests that FRs might act as one of the triggers for IP .

###22948250
OBJECTIVE	Repetitive transcranial magnetic stimulation ( rTMS ) is supposed to be not as effective in severe depression as it is in medium depression .
OBJECTIVE	We evaluated the treatment response to an ultra-high-frequency ( UHF ; 30 Hz ) approach , which was used to maximize the rTMS efficacy in severely ill patients .
METHODS	43 severely depressed patients were included in the randomized , double-blind study and received either rTMS with 30 Hz over the left dorsolateral prefrontal cortex or sham condition for 3 weeks as an add-on therapy to stable antidepressant medication .
METHODS	Hamilton Depression Rating Scale ( HDRS ) and cognitive performance were evaluated before and after the intervention .
RESULTS	In the active UHF group , the HRDS score was reduced by about 7.2 , whereas the sham condition showed a smaller reduction of the HDRS score with 3.9 .
RESULTS	However , lithium as a covariant was responsible for the outcome difference , not the group of stimulation .
RESULTS	No adverse events were reported .
RESULTS	Comparing the differences of both groups in the pre - and post-study performance in a trail-making test , a group effect for the UHF group that was not influenced by the lithium intake was observed .
CONCLUSIONS	A 30-Hz left prefrontal rTMS in severely depressed patients was safe and no adverse events occurred .
CONCLUSIONS	Due to a strong effect of lithium as a covariate , we could not demonstrate favorable antidepressant effects of the UHF stimulation compared to sham .
CONCLUSIONS	However , we found an improvement of processing speed performance in the UHF group , which covaried with improvement of psychomotor retardation .

###15839187
OBJECTIVE	To assess and compare healthcare utilization and costs over a 2-year period in older patients ( > or = 60 years ) with type 2 diabetes receiving combination therapy with rosiglitazone plus a sulfonylurea ( glipizide ) or progressive up-titration of glipizide monotherapy .
METHODS	Two-year , randomized , double-blind , parallel-group clinical trial .
METHODS	Older type 2 diabetic patients initially receiving submaximal doses of a sulfonylurea were randomized to receive rosiglitazone plus glipizide ( n = 115 ) or up-titrated glipizide monotherapy ( n = 110 ) .
METHODS	Information on patient self-reported healthcare utilization ( hospitalizations , emergency department [ ED ] visits , physician office visits ) was collected prospectively for the duration of the trial .
METHODS	National average healthcare costs per unit were applied to calculate direct medical costs .
RESULTS	Demographic characteristics of the 2 groups were similar .
RESULTS	At the study 's end , glycemic values were better in the rosiglitazone-plus-glipizide group .
RESULTS	Compared with the glipizide group , patients receiving rosiglitazone plus glipizide had significantly fewer ED visits ( P = .0006 ) and hospitalizations ( P = .0263 ) .
RESULTS	Although the glipizide group had more unscheduled physician office visits , the difference was not statistically significant .
RESULTS	Estimated treatment costs per patient per month were significantly lower for the rosiglitazone-plus-glipizide group than for the glipizide group ( 480 dollars vs 645 dollars ; P < .05 ) .
CONCLUSIONS	Addition of rosiglitazone to sulfonylurea therapy was associated with decreased use of medical resources , in particular hospitalizations and ED visits , compared with progressive sulfonylurea up-titration .
CONCLUSIONS	Although causality could not be established , this therapeutic approach could improve clinical outcomes in patients with type 2 diabetes and reduce healthcare utilization and costs .

###16051958
OBJECTIVE	Certain anthracycline-containing adjuvant chemotherapy regimens are associated with improved relapse-free survival ( RFS ) and overall survival ( OS ) compared with the classic regimen of cyclophosphamide , methotrexate , and fluorouracil in women with early-stage breast cancer .
METHODS	Between 1989 and 1993 , 710 pre - and perimenopausal women with axillary node-positive breast cancer were randomly assigned to either cyclophosphamide 75 mg/m ( 2 ) orally days 1 through 14 , epirubicin 60 mg/m ( 2 ) intravenously days 1 and 8 , and fluorouracil 500 mg/m ( 2 ) intravenously days 1 and 8 ( CEF ) or CMF ( cyclophosphamide 100 mg/m ( 2 ) orally days 1 through 14 , methotrexate 40 mg/m ( 2 ) intravenously days 1 and 8 , and fluorouracil 600 mg/m ( 2 ) intravenously days 1 and 8 ) .
METHODS	On the basis of follow-up to May 1997 ( median follow-up time , 59 months ) , there was a statistically significant improvement in RFS and OS for CEF compared with CMF .
RESULTS	The trial results are now updated , with a median follow-up of 10 years for live patients .
RESULTS	The 10-year RFS is 52 % for patients who received CEF compared with 45 % for CMF patients ( hazard ratio [ HR ] for CMF v CEF = 1.31 ; stratified log-rank , P = .007 ) .
RESULTS	The 10-year OS for patients who received CEF and CMF are 62 % and 58 % , respectively ( HR for CMF v CEF = 1.18 ; stratified log-rank , P = .085 ) .
RESULTS	The rates of acute leukemia have not changed since the original report , whereas the rates of congestive heart failure are slightly higher but acceptable ( four patients [ 1.1 % ] in the CEF group v one patient [ 0.3 % ] in the CMF group ) .
CONCLUSIONS	The previously demonstrated benefit of CEF compared with CMF adjuvant chemotherapy is maintained with longer follow-up in the MA5 trial .

###21941231
OBJECTIVE	Peripherally inserted central catheters are important but can be difficult to place in neonates .
OBJECTIVE	Therefore , we compared a near-infrared device , the Vein Viewer , to determine if its use would increase successful line placement , with standard techniques .
METHODS	Randomized controlled trial in preterm and term neonates in a level 3 Neonatal Intensive Care Unit .
RESULTS	In all , 115 subjects were enrolled with 59 randomized to the Vein Viewer group and 56 to the control group .
RESULTS	Overall , use of the Vein Viewer showed a trend to more successful placement 86 versus 75 % ; unadjusted odds ratio 2.33 ( 0.90 , 6.04 ; P = 0.08 ) .
RESULTS	Infants randomized to the Vein Viewer were more mature ( 30 2 weeks gestational age ( GA ) versus 28 2 weeks GA ; P = 0.08 ) .
RESULTS	After adjusting for GA , use of the Vein Viewer was significantly more likely to lead to successful line placement ( adjusted odds ratio 3.05 ( 1.10 , 1.82 ) ) .
CONCLUSIONS	The Vein Viewer improved successful placement with the most benefit seen in infants of greater GA. .

###16110017
OBJECTIVE	Accelerated repopulation is a main reason for locoregional failure after fractionated radiotherapy for head and neck squamous cell carcinoma ( HNSCC ) .
OBJECTIVE	Epidermal growth factor receptor ( EGFR ) is a key controller of cellular proliferation in HNSCC , which stimulated the current study to look for a direct link between EGFR status and a possible clinical advantage of accelerated radiotherapy .
METHODS	Immunohistochemical staining for EGFR was performed in 304 patients with available pretreatment tumor biopsy material among 918 patients randomized to receive continuous hyperfractionated accelerated radiotherapy versus conventionally fractionated radiotherapy .
METHODS	The EGFR index was estimated as the proportion of tumor cells with EGFR membrane staining .
RESULTS	Significant benefit in locoregional tumor control from continuous hyperfractionated accelerated radiotherapy was seen in patients with HNSCC with high EGFR expression ( 2P = .010 ) but not in those with low EGFR expression ( 2P = .85 ) .
RESULTS	EGFR status had no significant effect on survival or rate of distant metastases .
RESULTS	The EGFR index was significantly associated with histologic grade and microvessel density .
RESULTS	There was moderate support for an association between EGFR status and subsite within the head and neck region but no significant association with Ki-67 index , Ki-67 pattern , p53 index , p53 intensity , bcl-2 expression , or cyclin D1 index .
CONCLUSIONS	This study indicates a key role for the EGFR receptor in determining the proliferative cellular response to fractionated radiotherapy in HNSCC .
CONCLUSIONS	It also shows that we can select the dose-fractionation regime that has the greatest chance of benefiting the patient .
CONCLUSIONS	These results also encourage further development of EGFR targeting combined with fractionated radiotherapy in HNSCC .

###16456412
OBJECTIVE	To determine the doses of polyethylene glycol ( PEG ) 4000 without additional salts allowing normal bowel habits in childhood functional constipation .
METHODS	This multicenter noncomparative study allocated children to 4 groups : 6-12 months , 13 months-3 years , 4-7 years , and 8-15 years .
METHODS	Constipation was defined as < 1 stool/d for more than 1 month in children aged 6-12 months and < 3 stools/w for more than 3 months in older children .
METHODS	Children randomly received either a nominal or a double starting dose .
METHODS	Treatment scheduled for 3 months could be adapted .
METHODS	Data were collected daily by the parents and rated at each visit by the investigator .
RESULTS	In the 96 children included , the median ( interquartile ) effective daily doses were by groups ; 3.75 ( 2.50-5 .00 ) g , 6.00 ( 4.00-7 .43 ) g , 11.71 ( 7.00-16 .00 ) g , and 16.00 ( 16.00-24 .00 ) g , respectively , i.e. , around 0.50 g/day/kg with a potential increment of the maintenance dose with higher initial dosages .
RESULTS	More children had a final dosage identical to the initial one when started on the nominal dose ( 73 % ) than with the double one ( 42 % , P < 0.003 ) .
RESULTS	More than 90 % of children recovered normal bowel habits .
RESULTS	Fecal soiling ceased in > 60 % of children with this symptom at enrolment .
RESULTS	Fecal mass in the rectum and abdominal pain were markedly reduced and appetite improved .
CONCLUSIONS	A daily dose of PEG 4000 around 0.50 g/day/kg in children aged 6 months to 15 years is effective in more than 90 % of constipated children and 60 % of those with fecal soiling .

###21760515
OBJECTIVE	This study assessed the efficacy of endotracheal intubation using a double bending lightwand in patients with an anticipated difficult airway because of a short thyromental distance .
METHODS	On the basis of the shape of the lightwand used , 68 patients with a thyromental distance of less than 65 mm undergoing general anaesthesia were randomly allocated to one of two groups .
METHODS	In the conventional bending group ( n = 34 ) , the lightwand was bent at 6.5 cm from the distal end to 90 angle .
METHODS	In the double bending group ( n = 34 ) , the lightwand was bent 30 at 15 cm from its tip in addition to the conventional bending .
METHODS	The ease of insertion was assessed by the lightwand search time and success rate at the first attempt .
METHODS	Post-operative complications , if any , were noted .
RESULTS	The success rate of intubation at the first attempt was higher for the double bending group ( 94 vs. 74 % , P < 0.05 ) .
RESULTS	The search time was significantly shorter in the double bending group than the conventional bending group ( 10 6 vs. 15 8 s , P < 0.01 ) .
RESULTS	Mean blood pressure and heart rate increased after intubation in both groups ( P < 0.05 ) , but there were no significant differences between the groups .
RESULTS	The incidence of post-operative sore throat and mucosal bleeding was not significantly different between the groups .
CONCLUSIONS	We conclude that the double bending lightwand is associated with a greater success rate of intubation in patients with an anticipated difficult airway because of a short thyromental distance .

###24216257
OBJECTIVE	In end-stage renal disease ( ESRD ) patients , malnutrition is mainly addressed from a pharmacological but not educational point of view .
OBJECTIVE	Therefore , the objective of this study was to implement a nutritional education program ( NEP ) and to evaluate and compare its effectiveness in the treatment and prevention of malnutrition with oral supplementation ( OS ) - the standard treatment in these patients .
METHODS	This study was a longitudinal , 4-month prospective study .
METHODS	The study was conducted from January to May 2012 in the Hemodialysis Fresenius Medical Care Clinic of Murcia .
METHODS	One hundred twenty patients with ESRD undergoing hemodialysis were randomly assigned to a NEP or to OS .
METHODS	Patients assigned to the NEP group followed an educational program for 4months that aimed to improve general nutritional knowledge and included culinary recommendations and an elaboration of balanced menus .
METHODS	The OS group received a nutritional supplement during the hemodialysis procedure .
METHODS	The main outcome measure was certain biochemical markers of nutritional and metabolic status .
METHODS	Nutrition knowledge was also evaluated .
RESULTS	After 4months of intervention , nutritional knowledge was increased in all patients ( P < .050 ) after the NEP , which was reflected in a decrease in the prevalence of malnutrition , especially in this group .
RESULTS	Creatinine clearance , total protein serum values , and other biochemical parameters improved significantly in both groups ( P < .050 in all cases ) , although other parameters such as C-reactive protein were impaired only in the NEP group .
CONCLUSIONS	The NEP was at least as effective as OS for preventing and even treating malnutrition in patients with chronic renal failure on hemodialysis , improving their nutritional status , which may result in a long-term decrease in the mortality and morbidity of these patients .

###18971135
OBJECTIVE	To investigate the efficacy of placing bupivacaine-soaked Spongostan ( Ferrosan , Soeborg , Copenhagen , Denmark ) in episiotomy beds for relief of postpartum pain .
METHODS	Randomized , controlled study ( Canadian Task Force classification I ) .
METHODS	University medical school .
METHODS	Women with mediolateral episiotomy .
METHODS	Patients were recruited and randomized into 2 groups by using a random number table .
METHODS	Group I ( control group ) received local lignocaine infiltration 1 % up to 20 mL .
METHODS	For group II ( Spongostan group ) , in addition to local lignocaine infiltration , bupivacaine-soaked Spongostan was placed in the episiotomy bed .
METHODS	All patients received routine postpartum perineal care in addition to the regular pain drugs ( 75 mg of diclofenac every 4 hours if needed ) .
METHODS	The primary outcome for the study was severity of pain , rated on a 10-cm visual analog scale from 0 to 10 .
METHODS	Rating was recorded at 0 , 1 , 1.5 , 2 , 6 , and 24 hours after delivery .
RESULTS	In all , 48 women were randomized to group I ( local lignocaine alone ) and 51 women to group II ( local lignocaine plus Spongostan ) .
RESULTS	The Spongostan and control groups were similar with respect to maternal age , parity , gestational age , maternal weight , and neonatal birth weight ( p > .05 ; CI for difference : -2.6 / 10 , 0.1 / 0.3 , 0.3 / 0.7 , 6.9 / 1.7 , and -7 / 1.9 , respectively ) .
RESULTS	Episiotomy length ( both vaginal and perineal ) and episiotomy depth were higher in Spongostan group than control group ( p < .05 ; 95 % CI : -0.9 / 0 , -0.8 / -0.1 , and -0.6 / 0 , respectively ) .
RESULTS	However , episiotomy reconstruction time of both groups was similar ( p > .05 ; CI : 1.7 / 6.2 ) .
RESULTS	The pain score of Spongostan group was lower than control group and it was statistically significant at all time intervals ( 0 , 1 , 1.5 , 2 , 6 , and 24 hours ) between the Spongostan and control groups ( p < .05 ; CI : 0.6 / 1.9 , 1.1 / 2.4 , 1.0 / 2.5 , 0.9 / 2.4 , 0.3 / 1.9 , and 0.5 / 1.8 , respectively ) .
RESULTS	Postpartum total analgesic requirement ( mg/person ) again was significantly lower in the Spongostan group than control group ( p < .01 ; CI : 0.1 / 0.4 ) .
CONCLUSIONS	Placement of bupivacaine-soaked spongostan into the episiotomy bed resulted in decreased postpartum pain and drug requirement .
CONCLUSIONS	It may be attributed to a higher drug concentration at episiotomy bed and prolonged drug effect .

###23537332
BACKGROUND	There is growing evidence that home telemonitoring can be advantageous in societies with increasing prevalence of chronic diseases.The main objective of this study is to evaluate the effect of a primary care-based telemonitoring intervention on the number and length of hospital admissions .
METHODS	A randomised controlled trial was carried out across 20 health centres in Bilbao ( Basque Country , Spain ) to assess the impact of home telemonitoring on in-home chronic patients compared with standard care .
METHODS	The study lasted for one year .
METHODS	Fifty-eight in-home patients , diagnosed with heart failure ( HF ) and/or chronic lung disease ( CLD ) , aged 14 or above and with two or more hospital admissions in the previous year were recruited .
METHODS	The intervention consisted of daily patient self-measurements of respiratory-rate , heart-rate , blood pressure , oxygen saturation , weight , body temperature and the completion of a health status questionnaire using PDAs .
METHODS	Alerts were generated when pre-established thresholds were crossed .
METHODS	The control group ( CG ) received usual care .
METHODS	The primary outcome measure was the number of hospital admissions that occurred at 12 months post-randomisation .
METHODS	The impact of telemonitoring on the length of hospital stay , use of other healthcare resources and mortality was also explored .
RESULTS	The intervention group ( IG ) included 28 patients and the CG 30 .
RESULTS	Patient baseline characteristics were similar in both groups .
RESULTS	Of the 21 intervention patients followed-up for a year , 12 had some admissions ( 57.1 % ) , compared to 19 of 22 controls ( 86.4 % ) , being the difference statistically significant ( p = 0.033 , RR 0.66 ; 95 % CI 0.44 to 0.99 ) .
RESULTS	The mean hospital stay was overall 9 days ( SD 4.3 ) in the IG versus 10.7 ( SD 11.2 ) among controls , and for cause-specific admissions 9 ( SD 4.5 ) vs. 11.2 ( SD 11.8 ) days , both without statistical significance ( p = 0.891 and 0.927 , respectively ) .
RESULTS	Four patients need to be telemonitored for a year to prevent one admission ( NNT ) .
RESULTS	There were more telephone contacts in the IG than in the CG ( 22.6 - SD 16.1 - vs. 8.6 - SD 7.2 - , p = 0.001 ) , but fewer home nursing visits ( 15.3 - SD 11.6 - vs. 25.4 - SD 26.3 - , respectively ) , though the difference was not statistically significant ( p = 0.3603 ) .
CONCLUSIONS	This study shows that telemonitoring of in-home patients with HF and/or CLD notably increases the percentage of patients with no hospital admissions and indicates a trend to reduce total and cause-specific hospitalisations and hospital stay .
CONCLUSIONS	Home telemonitoring can constitute a beneficial alternative mode of healthcare provision for medically unstable elderly patients .
BACKGROUND	Current Controlled Trials ISRCTN89041993 .

###23884909
OBJECTIVE	The assessment of pulmonary perfusion using dynamic contrast-enhanced ( DCE ) MRI is still limited in the clinical routine due to the necessity of breath holding .
OBJECTIVE	An acquisition technique for the quantitative assessment of pulmonary perfusion in free breathing was investigated in our study .
METHODS	10 healthy male volunteers underwent pulmonary DCE-MRI on a 1.5 T scanner .
METHODS	Each volunteer was examined twice : ( a ) in breath-hold half expiration and ( b ) during shallow free breathing .
METHODS	The pulmonary parenchyma was segmented automatically .
METHODS	The pulmonary plasma flow ( PPF ) and pulmonary plasma volume ( PPV ) were determined pixel-wise using a one-compartment model .
RESULTS	All examinations were of diagnostic image quality .
RESULTS	The measured mean values of the PPV were significantly lower in the breath-hold technique than during free breathing ( ( 10.22.8 ) ml/100ml vs. ( 12.73.9 ) ml/100ml ) ; p < 0.05 ) .
RESULTS	A significant difference was also observed between both PPF measurements ( mean PPF ( 206.2104.0 ) ml/100ml/min in breath-hold technique vs. ( 240.6114.0 ) ml/100ml/min during free breathing ; p < 0.05 ) .
CONCLUSIONS	Free-breathing DCE-MRI appears to be suitable for the quantitative assessment of the pulmonary perfusion in healthy volunteers .
CONCLUSIONS	The proposed segmentation and quantification approach does not suffer from the increased motion , as compared to the breath-holding measurement .
CONCLUSIONS	The increased PPV and PPF during free breathing are in accordance with the results of previous studies concerning breathing influence on perfusion parameters .
CONCLUSIONS	Overall , free-breathing DCE-MRI may be a promising technique for the assessment of pulmonary perfusion in various pathologies .

###18374458
BACKGROUND	Very long chain n-3 polyunsaturated fatty acids have modulating effects on inflammatory mechanisms .
BACKGROUND	Seal and fish oils are rich in n-3 polyunsaturated fatty acids , and possibly therefore high doses of nasoduodenally administered seal oil rapidly relieved inflammatory bowel disease ( IBD ) - associated joint pain in two recent studies .
BACKGROUND	In the present study , we compared the effects of short-term oral administration of seal oil and cod liver oil on IBD-related joint pain , leucotriene B ( 4 ) level , serum fatty acid profile and IBD activity .
METHODS	Thirty-eight patients with IBD-related joint pain were included in the study ; 21 had Crohn 's disease and 17 ulcerative colitis .
METHODS	Ten milliters of seal oil ( n = 18 ) or cod liver oil ( n = 20 ) was self-administered orally 3 times a day for 14 days before meals in a double-blind setting .
RESULTS	There were no significant differences between the two intervention groups or between Crohn 's disease and ulcerative colitis patients .
RESULTS	There was a tendency toward improvement in several joint pain parameters after both seal oil and cod liver oil administration .
RESULTS	Further , plasma leucotriene B ( 4 ) concentration , serum Sigma n-6 to Sigma n-3 , and arachidonic acid ( 20:4 n-6 ) to eicosapentaenoic acid ( 20:5 n-3 ) ratios were similarly reduced after administration of seal oil and cod liver oil .
CONCLUSIONS	No significant differences in the two treatment groups were seen ; in both groups , the changes in several joint pain parameters , leucotriene B ( 4 ) level of plasma , and serum fatty acid profile were putatively favourable .

###23868858
BACKGROUND	Atrial-based pacing is associated with lower risk of atrial fibrillation ( AF ) in sick sinus syndrome compared with ventricular pacing ; nevertheless , the impact of site and rate of atrial pacing on progression of AF remains unclear .
BACKGROUND	We evaluated whether long-term atrial pacing at the right atrial ( RA ) appendage versus the low RA septum with ( ON ) or without ( OFF ) a continuous atrial overdrive pacing algorithm can prevent the development of persistent AF .
RESULTS	We randomized 385 patients with paroxysmal AF and sick sinus syndrome in whom a pacemaker was indicated to pacing at RA appendage ON ( n = 98 ) , RA appendage OFF ( n = 99 ) , RA septum ON ( n = 92 ) , or RA septum OFF ( n = 96 ) .
RESULTS	The primary outcome was the occurrence of persistent AF ( AF documented at least 7 days apart or need for cardioversion ) .
RESULTS	Demographic data were homogeneous across both pacing site ( RA appendage/RA septum ) and atrial overdrive pacing ( ON/OFF ) .
RESULTS	After a mean follow-up of 3.1 years , persistent AF occurred in 99 patients ( 25.8 % ; annual rate of persistent AF , 8.3 % ) .
RESULTS	Alternative site pacing at the RA septum versus conventional RA appendage ( hazard ratio = 1.18 ; 95 % confidence interval , 0.79-1 .75 ; P = 0.65 ) or continuous atrial overdrive pacing ON versus OFF ( hazard ratio = 1.17 ; 95 % confidence interval , 0.79-1 .74 ; P = 0.69 ) did not prevent the development of persistent AF .
CONCLUSIONS	In patients with paroxysmal AF and sick sinus syndrome requiring pacemaker implantation , an alternative atrial pacing site at the RA septum or continuous atrial overdrive pacing did not prevent the development of persistent AF .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	UNIQUE IDENTIFIER : NCT00419640 .

###23415428
BACKGROUND	The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs ( LLDs ) in randomized clinical trials may be elucidated with population-based studies .
OBJECTIVE	To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy .
METHODS	This observational study used claims data from 9 million members of five United States health plans to identify patients ( 18 years ) who received > 2 statin and nonstatin LLDs during July 2000 to December 2004 .
METHODS	Inpatient International Classification of Diseases , Ninth Revision , Clinical Modification , codes for rhabdomyolysis ( 791.3 , 728.89 , and 728.88 ) were observed during the follow-up period ; cases were confirmed with patients ' medical records .
METHODS	Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure ; multivariate analysis was conducted .
RESULTS	The study cohort ( N = 473,343 ) received 490,988 and 11,624 person-years of LLD , and combination therapy , respectively .
RESULTS	Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims ; 42 cases were confirmed .
RESULTS	With atorvastatin as reference , rhabdomyolysis rates ( 95 % confidence interval ) were greatest for cerivastatin , 8.4 ( 2.3-21 .7 ) ; no difference among available statins was observed .
RESULTS	Rates for other LLD monotherapies were : niacin , 2.1 ( 0.3-7 .7 ) , ezetimibe , 2.1 ( 0.3-7 .8 ) , fenofibrate , 0 ( 0-1 .7 ) , and gemfibrozil , 2.0 ( 0.5-5 .2 ) .
RESULTS	Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis ( odds ratio 4.74 , 95 % confidence interval 1.1-21 .2 , P = .041 ) versus atorvastatin among the statins .
RESULTS	Combination therapies had increased rhabdomyolysis risk ( OR 7.1 , 1.6-31 .6 , P = .010 ) versus LLDs alone .
CONCLUSIONS	The risk of habdomyolysis among hospitalized patients receiving statins was low ; no difference among the available statins was evident .
CONCLUSIONS	Further data are needed to establish the risk profile but current findings already offer guidance to physicians .

###11897728
OBJECTIVE	To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen .
METHODS	Randomized controlled clinical trial .
METHODS	Nonprofit group-practice health maintenance organization ( HMO ) .
METHODS	HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing ( UBT ) .
METHODS	Those whose tests were positive for H pylori ( 23.3 % ) were provided a standard antibiotic regimen and randomly assigned to receive either usual-care counseling from a pharmacist or a longer adherence counseling session and a follow-up phone call from the pharmacist during drug treatment .
METHODS	All subjects were given the same 7-day course of omeprazole , bismuth subsalicylate , metronidazole , and tetracycline hydrochloride ( OBMT ) .
METHODS	Dyspepsia symptoms were recorded at baseline and following therapy .
RESULTS	The main outcome was eradication of H pylori as measured by UBT at 3-month follow-up .
RESULTS	Secondary outcomes were patient satisfaction and dyspepsia symptoms at 3-month follow-up .
RESULTS	Of the 333 participants randomly assigned to treatment , 90.7 % completed the 3-month follow-up UBT and questionnaires .
RESULTS	Overall eradication rate with the OBMT regimen was 80.5 % with no significant difference in eradication rates between the 2 groups ( P = 0.98 ) .
RESULTS	Conclusions In this study , additional counseling by pharmacists did not affect self-reported adherence to the treatment regimen , eradication rates , or dyspepsia symptoms but did increase patient satisfaction .

###16939033
OBJECTIVE	To evaluate the occluding ability of ammonium hexafluorosilicate ( SiF ) .
METHODS	Dentin disks prepared from human extracted teeth were grouped as follows to prepare different situations of dentin hypersensitivity : ( 1 ) those sonicated for 20 minutes ; ( 2 ) those treated with 0.5 mol/L EDTA for 2 minutes ; ( 3 ) those treated with 6 % citric acid for 2 minutes ; ( 4 ) those treated with 50 % citric acid for 2 minutes .
METHODS	Then , SiF or diamine silver fluoride ( AgF ) was applied to the dentin disks and the dentin tubule occlusion was observed with scanning electron microscopy ( SEM ) .
METHODS	The percent of open tubules before and after SiF or AgF treatment were measured by NIH image using SEM photographs .
METHODS	Also , the dentin permeability was measured .
RESULTS	SEM micrographs demonstrated that the dentin tubules were completely occluded by the precipitate after SiF treatment .
RESULTS	Also , the dentin permeability was reduced to 10.3 % .
RESULTS	In contrast , most of the dentin tubules remained open after AgF treatment .
RESULTS	EDXA analysis showed that the precipitate in the dentin tubules that forms after SiF treatment contains Si , Ca and P , indicating a silica-calcium phosphate complex .

###16841603
OBJECTIVE	The aim of this study was to evaluate the clinical efficacy of home-administered vital bleaching procedures and possible adverse effects derived from their use .
OBJECTIVE	One gel containing 3.5 % hydrogen peroxide with a 5 % potassium nitrate component ( FKD , Kin Lab ) was compared with a carbamide peroxide-based gel with a concentration of 10 % ( Opalescence , Ultradent ) .
METHODS	Two sample groups were designed , each composed of 8 patients .
METHODS	All patients employed both bleaching products , 1 in the maxillary arch and the other in the mandibular arch on a random basis .
METHODS	The treatment was applied for 3 hours a day for 4 weeks .
METHODS	The degree of bleaching was evaluated using the Vita guide arranged by brightness .
METHODS	Dental sensitivity was measured with a specially designed 4-point scale .
METHODS	Gingival irritation was registered by the presence or absence of lesions in the marginal gingiva related to treatment .
RESULTS	The degree of bleaching was similar with both products ( 4.8 Vita shade tabs ) .
RESULTS	The hydrogen peroxide product with potassium nitrate provoked less dental sensitivity , although the difference between the 2 products was insignificant ( P = .063 ) .
RESULTS	Gingival irritation appeared in 6 subjects , but was unrelated to the applied product .
CONCLUSIONS	Under the conditions of this study , no statistically significant differences were detected between 3.5 % hydrogen peroxide containing 5 % potassium nitrate ( FKD ) and the 10 % carbamide peroxide-based product ( Opalescence ) .

###18810296
OBJECTIVE	To determine whether a hypocaloric diet higher in protein can prevent the loss of lean mass that is commonly associated with weight loss .
METHODS	An intervention study comparing a hypocaloric diet moderately high in protein to one lower in protein .
METHODS	Study measurements were taken at the Wake Forest University General Clinical Research Center ( GCRC ) and Geriatric Research Center ( GRC ) .
METHODS	Twenty-four post-menopausal , obese women ( mean age = 58 + / - 6.6 yrs ; mean BMI = 33.0 + / - 3.6 kg/m2 ) .
METHODS	Two 20-week hypocaloric diets ( both reduced by 2800 kcal/wk ) were compared : one maintaining dietary protein intake at 30 % of total energy intake ( 1.2-1 .5 g/kg/d ; HI PROT ) , and the other maintaining dietary protein intake at 15 % of total energy ( 0.5-0 .7 g/kg/d ; LO PROT ) .
METHODS	The GCRC metabolic kitchen provided lunch and dinner meals which the women picked up 3 days per week and ate outside of the clinic .
METHODS	Body composition , including total body mass , total lean mass , total fat mass , and appendicular lean mass , assessed by dual energy x-ray absorptiometry , was measured before and after the diet interventions .
RESULTS	The HI PROT group lost 8.4 + / - 4.5 kg and the LO PROT group lost 11.4 + / - 3.8 kg of body weight ( p = 0.11 ) .
RESULTS	The mean percentage of total mass lost as lean mass was 17.3 % + / - 27.8 % and 37.5 % + / - 14.6 % , respectively ( p = 0.03 ) .
CONCLUSIONS	Maintaining adequate protein intake may reduce lean mass losses associated with voluntary weight loss in older women .

###15029544
BACKGROUND	The authors compared the analgesic effects and quality of rehabilitation of three analgesic techniques after total-hip arthroplasty in a double-blind , randomized trial .
METHODS	Forty-five patients were assigned to 1 of 3 groups , patient-controlled analgesia with morphine ( PCA ) , femoral nerve block ( FNB ) , or psoas compartment block ( PCB ) .
METHODS	At the end of the procedure performed under general anesthesia , nerve blocks using 2 mg/kg of 0.375 % bupivacaine and 2 microg/kg of clonidine were performed in the FNB ( n = 16 ) and PCB ( n = 15 ) groups .
METHODS	In the recovery room , all 3 groups received initial intravenous morphine titration if their pain score was higher than 30 on a 100-mm visual analog scale ( VAS ) , and then a PCA device was initiated .
METHODS	Morphine consumption was the primary end point to assess postoperative analgesia .
RESULTS	After extubation ( H0 ) , morphine titration was higher in the PCA group ( P < .05 ) .
RESULTS	During the first 4 postoperative hours ( H0 to H4 ) , morphine consumption per hour and VAS pain score were lower in the PCB group ( P < .05 ) .
RESULTS	After H4 , there was no difference in morphine consumption and VAS among groups , either at rest or during mobilization .
RESULTS	After H4 , morphine consumption remained lower than 0.5 mg/h , and VAS remained lower than 30 mm in the 3 groups .
RESULTS	In 4 patients of the PCB group , an epidural diffusion was noted .
RESULTS	Hip mobility and length of stay in the rehabilitation center were not different among the groups .
CONCLUSIONS	PCA is an efficient and safe analgesia technique .
CONCLUSIONS	FNB and PCB should not be used routinely after total-hip arthroplasty .

###23262925
OBJECTIVE	To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture .
METHODS	Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture .
METHODS	Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions .
METHODS	Standardized wound evaluations were performed at discharge ( days 3-4 ) and 4-6 weeks postoperatively .
METHODS	The primary outcome was a composite of wound disruption or infection within 4-6 weeks .
METHODS	Secondary outcomes included operative time , highest pain score on analog scale , cosmesis score , and patient scar satisfaction score .
METHODS	Analyses were by intent to treat .
RESULTS	Of 398 patients , 198 were randomized to staples and 200 to suture ( but four received staples ) .
RESULTS	Baseline characteristics including body mass index , prior cesarean delivery , labor , and type of skin incision were similar by group .
RESULTS	The primary outcome incidence at hospital discharge was 7.1 % for staples and 0.5 % for suture ( P < .001 , relative risk 14.1 , 95 % confidence interval [ CI ] 1.9-106 ) .
RESULTS	Of 350 ( 87.9 % ) with follow-up at 4-6 weeks , the cumulative risk of the primary outcome at 4-6 weeks was 14.5 % for staples and 5.9 % for suture ( P = .008 , relative risk 2.5 , 95 % CI 1.2-5 .0 ) .
RESULTS	Operative time was longer with suture closure ( median time of 58 versus 48 minutes ; P < .001 ) .
RESULTS	Pain scores at 72-96 hours and at 6 weeks , cosmesis score , and patient satisfaction score did not differ by group .
CONCLUSIONS	Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery .
BACKGROUND	: ClinicalTrials.gov , www.clinicaltrials.gov , NCT01008449 .
METHODS	: I.

###19281114
OBJECTIVE	To prospectively compare the clinical performance of two different resin composites for luting IPS Empress inlays and onlays .
METHODS	83 IPS Empress restorations were placed in 30 subjects .
METHODS	All restorations were inserted under rubber dam .
METHODS	43 inlays/onlays were luted with a self-adhesive resin cement [ RelyX Unicem ( RX ) ] .
METHODS	A multistep adhesive ( Syntac ) was used with Variolink II low viscosity ( SV ) and served as control ( n = 40 ) .
METHODS	The restorations were evaluated after 2 weeks : Baseline = 1st recall ( R1 ) , after 6 months ( R2 ) and after 1 year ( R3 ) by two calibrated examiners using the modified USPHS criteria .
RESULTS	From R1 to R3 , one failure was noticed in the SV group ( R2 ) due to marginal enamel chipping .
RESULTS	After 1 year of clinical service , SV revealed significantly better results regarding color match and integrity inlay ( Mann-Whitney U-test , P < 0.05 ) .
RESULTS	No statistically significant differences were observed between SV and RX for the remaining criteria ( Mann-Whitney U-test , P > 0.05 ) .

###17964871
OBJECTIVE	We aimed to evaluate safety and efficacy of granulocyte-colony stimulating factor treatment in patients with acute on chronic liver failure and the effect of granulocyte-colony stimulating factor on the expression level of CXCR4 , vascular endothelial growth factor receptor and very late activation antigen 4 .
METHODS	Twenty-four patients with acute on chronic liver failure were randomised to receive standard therapy , standard therapy + granulocyte-colony stimulating factor ( 5 microg/kg/day for 6 days ) and standard therapy + granulocyte-colony stimulating factor ( 15 microg/kg/day s.c. for 6 days ) .
METHODS	Data on CD34 + cell mobilisation were compared to age-matched peripheral blood haematopoietic stem cell donors treated with granulocyte-colony stimulating factor .
METHODS	On day third of treatment , the expression level of CXCR4 , vascular endothelial growth factor receptor and very late activation antigen 4 was analysed in mobilised CD34 + cells .
RESULTS	CD34 cell count increased after the second day of granulocyte-colony stimulating factor injection in both treatment groups compared to the linear increase observed in control .
RESULTS	After the fifth day the increase was significantly higher in healthy donors versus patients with acute on chronic liver failure .
RESULTS	A decrease in the expression of CXCR4 , very late activation antigen 4 and vascular endothelial growth factor receptor compared to premobilisation values was observed .
RESULTS	No major side effects were observed .
CONCLUSIONS	Granulocyte-colony stimulating factor treatment is able to induce CD34 mobilisation in patients with acute on chronic liver failure .
CONCLUSIONS	The expression pattern of CXCR4 , very late activation antigen 4 and vascular endothelial growth factor receptor suggests that these molecules are involved in the granulocyte-colony stimulating factor-induced stem cell mobilisation .

###11303491
OBJECTIVE	To examine the effect of increasing the variety of sensorially distinct but nutritionally identical foods on appetite , food intake and body weight , over 7 days , in men .
METHODS	Six younger , lean men ( mean ( s.d. ) age 27.0 ( 2.9 ) y ; weight 74.7 ( 3.9 ) kg ; height 1.78 ( 0.03 ) m ; body mass index ( BMI ) 23.6 ( 1.1 ) kg/m2 ) and six older , overweight men ( mean ( s.d. ) age 39.7 ( 2.9 ) y ; weight 89.2 ( 4.4 ) kg ; height 1.78 ( 0.04 ) m ; BMI 28.1 ( 0.5 ) kg/m2 ) were each studied three times during a 9 day protocol , whilst resident in the Human Nutrition Unit .
METHODS	On days 1-2 , subjects consumed a medium fat ( MF ) maintenance diet ( 40 % fat , 13 % protein and 47 % carbohydrate by energy ) calculated at 1.6 x resting metabolic rate ( RMR ) .
METHODS	On days 3-9 subjects had ad libitum access to MF foods ( 550 kJ/100 g ) with every item the same macronutrient composition and energy density .
METHODS	Subjects had continuous ad libitum access to 5 , 10 or 15 food items per day on the low-variety ( LV ) , medium-variety ( MV ) and high-variety ( HV ) treatments , respectively .
METHODS	The order of treatments was randomized across subjects .
METHODS	Subjective hunger was tracked hourly during waking hours using visual analogue scales ( VAS ) .
METHODS	Body weight ( as a proxy of changes in energy balance ) was measured before eating and after voiding , each morning .
RESULTS	Food and energy intake of the 12 men increased as the variety of foods increased , giving mean energy intakes of 10.13 , 11.00 and 11.89 MJ/day on the LV , MV and HV treatments , respectively ( F ( 2,20 ) = 10.32 ; P < 0.001 ) .
RESULTS	This effect was ascribable almost entirely to the lean men .
RESULTS	Energy intake amounted to 1.57 , 1.76 and 1.97 x RMR in the lean men and 1.33 , 1.40 and 1.45 x RMR , for the overweight men on the LV , MV and HV diets , respectively .
RESULTS	Weight changes amounted to -0.16 , -0.28 and + 0.43 kg ( lean ) -1.03 and -1.52 kg and -0.66 kg ( overweight ) , on the LV , MV and HV diets , respectively .
RESULTS	The overweight men may have constrained their energy intake relative to expected requirements .
RESULTS	This may have been due to a congnitive effect or an age effect .
RESULTS	There was no significant group or diet effect on subjectively rated hunger .
CONCLUSIONS	These data suggest that increasing the variety of sensorially distinct foods that are virtually identical in composition can increase food and energy intake and in the short to medium term can alter energy balance .

###22846159
OBJECTIVE	Presynaptic and post-synaptic glutamatergic modulation is associated with antidepressant activity that takes several weeks to reach a maximal full effect .
OBJECTIVE	Limiting mood elevating effects after single drug administration may be the result of compensatory synaptic processes .
OBJECTIVE	Therefore , using augmentation treatment with agents having presynaptic and post-synaptic effects on the glutamatergic system , this study aims to evaluate the effect of augmentation therapy on the rate of change in mood elevation in patients with bipolar depression .
METHODS	In a pilot study , 29 outpatients with bipolar depression on a stable lamotrigine dose regimen received placebo or memantine pills daily ( titrated up by 5mgweek to 20mg ) in a randomized , double-blind , parallel group , 8week study .
METHODS	Patients were evaluated weekly using the 17-item Hamilton Depression Rating Score ( HDRS ) and all data were analyzed simultaneously .
METHODS	Linear , exponential , maximal effect , Gompertz and inverse Bateman functions were evaluated using a Bayesian approach population pharmacodynamic model framework .
METHODS	In these models , differences in parameters were examined across the memantine and placebo augmentation groups .
RESULTS	A Gompertz function with a treatment switch on the parameter describing the speed of HDRS decline ( , 95 % confidence interval [ CI ] ) best described the data ( ( memantine ) = 1.8 , 95 % CI 0.9 , 3.6 ) , ( placebo ) = 1.2 , 95 % CI 0.5 , 3.5 ) ) .
RESULTS	Between subject variability was identified on baseline HDRS ( 2.9 , 95 % CI 1.5 , 4.4 ) and amplitude of score improvement ( 4.3 , 95 % CI 2.7 , 6.5 ) .
CONCLUSIONS	This pharmacodynamic approach identified an increased speed of response after memantine augmentation , compared with placebo augmentation in bipolar depression patients .

###22169248
BACKGROUND	Cognitive dysfunction is a key predictor of functional disability in schizophrenia .
BACKGROUND	Davunetide ( AL-108 , NAP ) is an intranasally administered peptide currently being developed for treatment of Alzheimer 's disease and related disorders .
BACKGROUND	This study investigates effects of davunetide on cognition in schizophrenia .
METHODS	Sixty-three subjects with schizophrenia received davunetide at one of two different doses ( 5 , 30 mg ) or placebo for 12 weeks in a multicenter , double-blind , parallel-group randomized clinical trial .
METHODS	The MATRICS Consensus Cognitive Battery ( MCCB ) assessed cognitive effects .
METHODS	The UCSD Performance-based Skills Assessment ( UPSA ) and the Schizophrenia Cognition Rating Scale ( SCoRS ) assessed functional capacity .
METHODS	Subjects continued their current antipsychotic treatment during the trial .
RESULTS	There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms ( p = .45 ) .
RESULTS	Estimated effect-size ( d ) values were .34 and .21 favoring the 5 and 30 mg doses vs. placebo , respectively .
RESULTS	For UPSA , there was a significant main effect of treatment across study arms ( p = .048 ) .
RESULTS	Between-group effect size ( d ) values were .74 and .48 , favoring the 5 and 30 mg doses , respectively .
RESULTS	No significant effects were observed on the SCoRS or on symptom ratings .
RESULTS	No significant side effects or adverse events were observed .
CONCLUSIONS	Davunetide was well tolerated .
CONCLUSIONS	Effects of davunetide on MCCB-rated cognition were not significant relative to placebo .
CONCLUSIONS	In contrast , a significant beneficial effect was detected for the UPSA .
CONCLUSIONS	Based upon effect-size considerations , sample sizes of at least 45-50 subjects/group would be required to obtain significant effects on both MCCB and UPSA , providing guidance for continued clinical development in schizophrenia .

###11136260
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) results from a progressive decline in lung function , which is thought to be the consequence of airway inflammation .
BACKGROUND	We hypothesized that antiinflammatory therapy with inhaled corticosteroids would slow this decline .
METHODS	We enrolled 1116 persons with COPD whose forced expiratory volume in one second ( FEV1 ) was 30 to 90 percent of the predicted value in a 10-center , placebo-controlled , randomized trial of inhaled triamcinolone acetonide administered at a dose of 600 microg twice daily .
METHODS	The primary outcome measure was the rate of decline in FEV1 after the administration of a bronchodilator .
METHODS	The secondary outcome measures included respiratory symptoms , use of health care services , and airway reactivity .
METHODS	In a substudy of 412 participants , we measured bone density in the lumbar spine and femur at base line and one and three years after the beginning of treatment .
RESULTS	The mean duration of follow-up was 40 months .
RESULTS	The rate of decline in the FEV1 after bronchodilator use was similar in the 559 participants in the triamcinolone group and the 557 participants in the placebo group ( 44.2 + / -2.9 vs. 47.0 + / -3.0 ml per year , P = 0.50 ) .
RESULTS	Members of the triamcinolone group had fewer respiratory symptoms during the course of the study ( 21.1 per 100 person-years vs. 28.2 per 100 person-years , P = 0.005 ) and had fewer visits to a physician because of a respiratory illness ( 1.2 per 100 person-years vs. 2.1 per 100 person-years , P = 0.03 ) .
RESULTS	Those taking triamcinolone also had lower airway reactivity in response to methacholine challenge at 9 months and 33 months ( P = 0.02 for both comparisons ) .
RESULTS	After three years , the bone density of the lumbar spine and the femur was significantly lower in the triamcinolone group ( P < or = 0.007 ) .
CONCLUSIONS	Inhaled triamcinolone does not slow the rate of decline in lung function in people with COPD , but it improves airway reactivity and respiratory symptoms and decreases the use of health care services for respiratory problems .
CONCLUSIONS	These benefits should be weighed against the potential long-term adverse effects of triamcinolone on bone mineral density .

###15863535
OBJECTIVE	To test the effectiveness of a brief intervention in the reduction of prenatal alcohol consumption by women when a partner is included .
METHODS	Randomized trial of a single session brief intervention given by the study nurse or principal investigator for 304 pregnant women and their partners .
METHODS	The women had positive T-ACE ( Tolerance , Annoyed , Cut down , Eye-opener , an alcohol screening test ) results and were at risk for alcohol consumption while pregnant .
METHODS	All completed initial diagnostic and postpartum interviews .
RESULTS	Fewer than 20 % of participants ( median 11.5 weeks of gestation ) were abstinent at study enrollment , averaging more than 1.5 drinks per episode .
RESULTS	Nearly 30 % had 2 or more drinks at a time while pregnant .
RESULTS	Prenatal alcohol use declined in both the treatment and control groups after study enrollment , based on a 95 % follow-up rate .
RESULTS	Factors associated with increased prenatal alcohol use after randomization included more years of education , extent of previous alcohol consumption , and temptation to drink in social situations .
RESULTS	Brief interventions for prenatal alcohol reduced subsequent consumption most significantly for the women with the highest consumption initially ( regression coefficient , b = -0.163 , standard error ( b ) = 0.063 , P < .01 ) .
RESULTS	Moreover , the effects of the brief intervention were significantly enhanced when a partner participated ( b = -0.932 , standard error ( b ) = 0.468 ) , P < .05 ) .
CONCLUSIONS	Pregnant women with the highest levels of alcohol use reduced their drinking most after a brief intervention that included their partners .
CONCLUSIONS	Recommendations include consistent screening for prenatal alcohol use followed by diagnostic assessment when indicated , and if confirmed by other studies , a patient-partner brief intervention for the heaviest drinkers .

###16358301
BACKGROUND	The efficacy in pediatric acute myeloid leukemia ( AML ) of single-agent methotrexate ( MTX ) at a higher dose than previously applied , 1,000 mg/m2 , given as a theoretically beneficial 36-hr continuous infusion , is unknown , but may be beneficial based on preclinical data .
METHODS	We performed a therapeutic window study in children with first relapsed AML treated in four different countries .
RESULTS	Based on a comparison between the percentage of leukemic blasts in the bone marrow shortly before and 7-10 days after the MTX infusion , none of the first cohort of nine patients showed a good response , defined as a reduction of blasts of at least 50 % .
RESULTS	Therefore , the study was closed , concluding that the probability of a good response in this patient-group was most likely to be less than 30 % .
RESULTS	By that time , another four patients had been enrolled , of which one patient with a late relapsed AML FAB type M7 showed a good response .
RESULTS	Toxicity of MTX was limited and tolerable .
CONCLUSIONS	This study shows that single-agent MTX in the applied regimen in pediatric relapsed AML has limited efficacy .
CONCLUSIONS	However , it also demonstrates the feasibility of an international and therapeutic window phase II study in pediatric relapsed AML .

###8560996
BACKGROUND	Prostaglandin E2 for local application has been widely used for preinduction cervical ripening in cases presenting with an unfavorable cervical state .
BACKGROUND	The optimal way of administering prostaglandin E2 , however , remains unclear .
BACKGROUND	The aim of this study was to compare the effect of multiple application of 0.5 mg Minprostin intracervical Gel to the effect of 3 mg Minprostin vaginal tablets in priming the uterine cervix and inducing labor in an open , prospective , randomised study .
METHODS	PGE2 was applied up to three times a day for two days until ripening was obtained or labor induced .
METHODS	In case no progress took place amniotomy was performed and i.v. oxytocin stimulation one hour later if necessary .
METHODS	A total of 208 pregnant women , consecutively admitted for induction of delivery , with Bishop Scores 0-5 , were included .
RESULTS	Minprostin gel ( group I ) and Minprostin tablets ( group II ) were equally effective in ripening the cervix .
RESULTS	Delivery within 48 hours was achieved in 59 % and 63 % respectively .
RESULTS	The mean number of applications was 2.6 ( s.d. 1.6 ) and 2.7 ( s.d. 1.3 ) respectively .
RESULTS	In case more than four doses were required no further effect was seen on delivery rates .
RESULTS	Rates of cesarean section ( performed in 15 % and 18 % respectively ) , labor induction ( 3 % / 1 % ) , drop outs ( 14 % / 12 % ) and failed inductions ( 10 % / 5 % ) were comparable .
RESULTS	Patients in group I had a significantly lower demand for analgesia .
RESULTS	A significantly shorter induction-delivery interval in group II was seen in patients with preinduction Bishop scores 3-5 compared to patients with Bishop scores 0-2 .
RESULTS	Side effects were few .
RESULTS	Both procedures appear safe .
CONCLUSIONS	Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets in cases presenting with an unfavorable cervical state is equally effective .

###25162028
OBJECTIVE	The 5-year clinical outcomes and prognostic factors of nasopharyngeal carcinoma ( NPC ) patients treated with intensity modulated radiotherapy ( IMRT ) were evaluated .
METHODS	Six hundred ninety five NPC patients primarily treated with IMRT in Sichuan Cancer Hospital from January , 2003 to December , 2006 were analyzed retrospectively , including 540 males and 155 females .
METHODS	The prescription dose was delivered as follows : gross target volume ( GTVnx ) 67-76 Gy in 30-33 fractions , positive neck lymph nodes ( GTVln-R/L ) 60-70 Gy in 30-33 fractions , high-risk clinical target volume ( CTV1 ) 60-66 Gy , low-risk clinical target volume ( CTV2 ) 54-60 Gy , and clinical target volume of cervical lymph node regions ( CTVln ) 50-55 Gy .
RESULTS	The 5-year local control ( LC ) , regional control , distant metastasis-free survival ( DMFS ) , disease free survival , disease specific survival , and overall survival ( OS ) rates were 89.8 % , 95.2 % , 74.1 % , 69.6 % , 83.2 % , and 77.1 % .
RESULTS	The 5-year DMFS of IMRT and IMRT combined with chemotherapy was 62.1 % and 70.9 % , the OS of them was 72.9 % and 79.1 % .
RESULTS	The incidence of grade 3 acute and late toxicity was 38.3 % and 4.2 % , respectively .
CONCLUSIONS	The 5-year LC and OS rate of NPC treated with IMRT was 89.8 % and 77.1 % .
CONCLUSIONS	The clinical stage , N stage , volume of GTVnx , and chemotherapy were the main prognostic factor for the OS .
CONCLUSIONS	Distant metastasis was the main pattern of failure .

###19689979
BACKGROUND	Retention of skills and knowledge after neonatal resuscitation courses ( NRP ) is known to be problematic .
BACKGROUND	The use of cognitive aids is mandatory in industries such as aviation , to avoid dependence on memory when decision-making in critical situations .
BACKGROUND	We aimed to prospectively investigate the effect of a cognitive aid on the performance of simulated neonatal resuscitation .
METHODS	Thirty-two anaesthesia residents were recruited .
METHODS	The intervention group had a poster detailing the NRP algorithm and the control group did not .
METHODS	Video recordings of each of the performances were analysed using a previously validated checklist by a peer , an expert anaesthetist , and an expert neonatologist .
RESULTS	The median ( IQR ) checklist score in the control group [ 18.2 ( 15.0-20 .5 ) ] was not significantly different from that in the intervention group [ 20.3 ( 18.3-21 .3 ) ] ( P = 0.08 ) .
RESULTS	When evaluated by the neonatologist , none of the subjects correctly performed all life-saving interventions necessary to pass the checklist .
RESULTS	A minority of the intervention group used the cognitive aid frequently .
CONCLUSIONS	Retention of skills after NRP training is poor .
CONCLUSIONS	The infrequent use of the cognitive aid may be the reason that it did not improve performance .
CONCLUSIONS	Further research is required to investigate whether cognitive aids can be useful if their use is incorporated into the NRP training .

###16163870
OBJECTIVE	The aim of this study was to determine the caries-protective effect of 3 different desensitizing agents ( Seal & Protect 2.0 , D/Sense 2 , and Gluma Desensitizer ) on root dentin in vitro .
METHODS	The root surfaces of 60 freshly extracted , caries-free human molars were used .
METHODS	After removing the cementum , the teeth were coated with an acid-resistant nail varnish , exposing 2 rectangular windows of 2 X 3 mm each on the root surface .
METHODS	One window served as an untreated control , and the other window was treated with 1 of the desensitizing agents .
METHODS	The specimens were randomly distributed among the following experimental groups : group A , D/Sense 2 ; group B , Seal & Protect 2.0 ; and group C , Gluma Desensitizer .
METHODS	Subsequently , all specimens were demineralized for 14 days with acidified gel ( HEC , pH 4.8 , 37 degrees C ) .
METHODS	Two dentinal slabs were cut from each window .
METHODS	The slabs were ground to a thickness of 80 microm and immersed in water .
METHODS	The demineralization depth was determined using a polarized light microscope .
RESULTS	The nontreated control specimens showed lesions with a mean depth of 84.9 microm ( + / - 6.0 ) .
RESULTS	In the specimens treated with the desensitizing agents , lesion depth was generally significantly reduced .
RESULTS	Statistical analysis revealed significantly lower values for the specimens in group B in comparison with the others .
CONCLUSIONS	Within the limitations of an in vitro investigation , it can be concluded that the demineralization of the root surface can be hampered by applying the desensitizing agents tested .

###17891560
OBJECTIVE	To investigate the effects of upper limbs ' encircling motion ( ULEM ) apparatus on motor function of patients with stroke .
METHODS	This study adopted a single-blind , prospective , randomized control design .
METHODS	From July 2003 to September 2005 , 44 inpatients suffering from stroke in Jiangsu Province Hospital were enrolled in this study .
METHODS	All the subjects were randomized into two groups .
METHODS	Group A received ULEM therapy and conventional physical therapy ( PT ) aand group B received PT only .
METHODS	Blood pressure , pulse , Brunnstrom stage and Barthel Index were tested before and after 20 days ' treatment .
RESULTS	In group A , according to Brunnstrom stage , the effective rates of hand , upper extremities and lower extremities were 20.0 % , 80.0 % and 100.0 % , respectively , and the total effective rate improved significantly compared to that of group B ( p < 0.05 ) , especially lower extremities ( p < 0.05 ) .
RESULTS	There was no statistical difference in Barthel Indexes between two groups ( p > 0.05 ) .
CONCLUSIONS	ULEM apparatus can significantly improve integrative motor function of extremities of patients with stroke .
CONCLUSIONS	It is a safe and effective treatment .

###12637119
BACKGROUND	Parallel with the development of hypotheses regarding cholinergic involvement in geriatric memory dysfunction , the first attempts to treat patients with Alzheimer 's disease ( AD ) involved the cholinergic-precursor loading approach .
BACKGROUND	Despite encouraging early results , well-controlled clinical trials did not confirm a clinical utility of cholinergic precursors such as choline and lecithin ( phosphatidylcholine ) in AD .
OBJECTIVE	This study assessed the efficacy and tolerability of the cholinergic precursor choline alfoscerate ( CA ) in the treatment of cognitive impairment due to mild to moderate AD .
METHODS	In this multicenter , double-blind , randomized , placebo-controlled trial , patients affected by mild to moderate dementia of the Alzheimer type were treated with CA ( 400-mg capsules ) or placebo capsules , 3 times daily , for 180 days .
METHODS	Efficacy outcome measures that were assessed at the beginning of the investigation and after 90 and 180 days of treatment included scores of the Alzheimer 's Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog ) , the Mini-Mental State Examination ( MMSE ) , the Global Deterioration Scale ( GDS ) , the Alzheimer 's Disease Assessment Scale-Behavioral Subscale ( ADAS-Behav ) , all items of the Alzheimer 's Disease Assessment Scale ( ADAS-Total ) , and the Clinical Global Impression ( CGI ) scale .
METHODS	The Global Improvement Scale ( GIS ) score was assessed after 90 and 180 days of treatment .
RESULTS	A total of 261 patients ( 132 in the CA group , 129 in the placebo group ) were enrolled in the study .
RESULTS	The mean ( SD ) age in the CA group was 72.2 ( 7.5 ) years ( range , 60-80 years ) , and in the placebo group it was 71.7 ( 7.4 ) years ( range , 60-80 years ) .
RESULTS	The CA group comprised 105 women and 27 men ; the placebo group , 94 women and 35 men .
RESULTS	The mean decrease in ADAS-Cog score in patients treated with CA was 2.42 points after 90 days of treatment and 3.20 points at the end of the study ( day 180 ) ( P < 0.001 vs baseline for both ) , whereas in patients receiving placebo the mean increase in ADAS-Cog score was 0.36 point < 1 after 90 days of treatment and 2.90 points after 180 days of treatment ( P < 0.001 vs baseline ) .
RESULTS	In the CA group , all other assessed parameters ( MMSE , GDS , ADAS-Behav , ADAS-Total , and CGI ) consistently improved after 90 and 180 days versus baseline , whereas in the placebo group they remained unchanged or worsened .
RESULTS	Statistically significant differences were observed between treatments after 90 and 180 days in ADAS-Cog , MMSE , GDS , ADAS-Total , and CGI scores and after 180 days of treatment in ADAS-Behav and GIS scores .
CONCLUSIONS	The results of this study suggest the clinical usefulness and tolerability of CA in the treatment of the cognitive symptoms of dementia disorders of the Alzheimer type .

###20492039
OBJECTIVE	To explore the activities of daily living and psychological well-being of older people living in nursing homes and also to examine the effectiveness of a gardening programme in enhancing socilaisation and life satisfaction , reducing loneliness and promoting activities of daily living for older people living in nursing homes .
BACKGROUND	Life in nursing homes can mean very limited physical and social activity , leading to further decline in function for many older people .
METHODS	This was a quasi-experimental pre and posttest control group design .
METHODS	Older people from nursing homes were invited to join the eight week indoor gardening programme ( experimental group ) , while older people in other nursing homes were treated as the control group ; they received regular care without the eight week indoor gardening programme .
METHODS	There were 26 older people ( 25 female and one male ; mean age 85 years ) in the experimental group and 27 ( 20 female and seven male ; mean age 82 years ) in the control group .
METHODS	Demographic data including age , gender , educational level and financial situation were collected , in addition to information regarding life satisfaction , loneliness , physical activity and social network situation , before and after the eight week indoor gardening programme for both the experimental and control groups .
METHODS	Also , details of experimental group subjects ' experience of the indoor gardening programme were elicited using open-ended questions .
RESULTS	There were significant improvements in life satisfaction and social network and a significant decrease in perception of loneliness for older people in the experimental group after the eight week indoor gardening programme , while the activities of daily living were unchanged for both groups after the programme .
CONCLUSIONS	Given the positive effects of gardening activities , it is suggested that they be promoted more widely among nursing home residents .

###15389239
OBJECTIVE	The purpose of the current study was to determine whether there is any incremental benefit to routine intravascular ultrasound ( IVUS ) guidance of percutaneous coronary intervention .
RESULTS	We compared the outcome of 796 patients who underwent an IVUS study ( IVUS group ) during the index stent procedure with 8274 patients who did not have an IVUS study ( angiography group ) .
RESULTS	The primary end point was the composite end point of death , myocardial infarction , or ischemia-driven target vessel revascularization within 9 months of the index stent procedure .
RESULTS	There were statistically significant differences in multiple procedural characteristics .
RESULTS	Most importantly , those patients who underwent an IVUS study had a larger postprocedural minimal lumen diameter and smaller postprocedural percent diameter stenosis .
RESULTS	However , there was no significant difference between the IVUS group and the angiography group with respect to the primary end point ( RR 1.10 , 95 % CI 0.91 , 1.32 ) or any of the individual clinical end points .
RESULTS	Adjustment for multiple clinical and procedural characteristics did not significantly alter these findings .
CONCLUSIONS	These data suggest that the routine performance of IVUS during stent placement influences the performance of the procedure , as judged by differences in procedural characteristics , but does not improve clinical outcome at 9 months .

###9510317
OBJECTIVE	The aim of our study was to compare the efficacy and safety of oral mesalazine with mesalazine suppositories in patients with active ulcerative proctitis .
METHODS	A four-week , randomized , single-blind trial was performed in 58 patients with active , histologically confirmed ulcerative proctitis ( < or = 15 cm ) to evaluate the efficacy and safety of oral 800-mg mesalazine tablets taken three times per day ( n = 29 ) compared with 400 mg of mesalazine suppositories administered three times per day ( n = 29 ) .
METHODS	Patients were evaluated at study entry and after two and four weeks .
METHODS	Efficacy evaluations included a disease activity index , which represents a score with four variables : stools frequency , rectal bleeding , mucosal appearance , and physician 's assessment of disease severity .
METHODS	Histologic activity was also assessed at study entry and after two and four weeks in accordance with the criteria by Truelove and Richard .
METHODS	Safety assessment included clinical laboratory parameters and adverse event reports .
RESULTS	There were no significant differences with regard to baseline comparisons of demographics and severity between the two treatment groups .
RESULTS	Improvement in mean disease activity index score was significantly greater with suppositories compared with oral mesalazine , both at two-week and four-week visits ( mean disease activity index scores at baseline , two , and four weeks : suppositories = 7.7 , 2.59 , and 1.48 ; tablets = 7.42 , 5.72 , and 3.48 , respectively ( P < 0.001 ) ) .
RESULTS	The rate of histologic remission was significantly greater with suppositories compared with tablets both at two and four weeks ( P < 0.01 ) .
RESULTS	There were no significant differences in adverse events or clinical laboratory results between treatment groups .
CONCLUSIONS	Results of this study indicate that treatment with mesalazine suppositories produces earlier and significantly better results than oral mesalazine in the treatment of active ulcerative proctitis .

###19299322
BACKGROUND	Ginkgo biloba is one of the most popular herbal supplements in the world .
BACKGROUND	The supplement has been shown to induce the enzymatic activity of CYP2C19 , the main cytochrome P450 isozyme involved in voriconazole metabolism .
BACKGROUND	Because this enzyme exhibits genetic polymorphism , the inductive effect was expected to be modulated by the CYP2C19 metabolizer status .
OBJECTIVE	To examine the possible effects of Ginkgo biloba as an inducer of CYP2C19 on single-dose pharmacokinetics of voriconazole in Chinese volunteers genotyped as either CYP2C19 extensive or poor metabolizers .
METHODS	Fourteen healthy , nonsmoking volunteers-7 CYP2C19 extensive metabolizers ( 2C19 ( * ) 1/2C19 ( * ) 1 ) and 7 poor metabolizers ( 2C19 ( * ) 2/2C19 ( * ) 2 ) - were selected to participate in this study .
METHODS	Pharmacokinetics of oral voriconazole 200 mg after administration of Ginkgo biloba 120 mg twice daily for 12 days were determined for up to 24 hours by liquid chromatography-electrospray tandem mass spectrometry in a 2-phase randomized crossover study with 4-week washout between phases .
RESULTS	For extensive metabolizers , the median value for voriconazole area under the plasma concentration-time curve from zero to infinity ( AUC ( 0 - ) ( infinity ) ) was 5.17 microg.h / mL after administration of voriconazole alone and 4.28 microg.h / mL after voriconazole with Ginkgo biloba ( p > 0.05 ) .
RESULTS	The other pharmacokinetic parameters of voriconazole such as AUC ( 0-24 ) , time to reach maximum concentration , half-life , and apparent clearance also did not change significantly for extensive metabolizers in the presence of Ginkgo biloba .
RESULTS	Pharmacokinetic parameters followed a similar pattern for poor metabolizers .
CONCLUSIONS	The results suggest that 12 days of treatment with Ginkgo biloba did not significantly alter the single-dose pharmacokinetics of voriconazole in either CYP2C19 extensive or poor metabolizers .
CONCLUSIONS	Therefore , the pharmacokinetic interactions between voriconazole and Ginkgo biloba may have limited clinical significance .

###21043366
OBJECTIVE	To determine steady-state plasma concentrations and the pharmacokinetic profile of the essential components of synthetic conjugated estrogens , B ( SCE-B ) , particularly total estrone and delta8,9-dehydroestrone ( DHE ) , after oral administration of a modified-released tablet .
METHODS	A randomized , multiple-dose , pharmacokinetic study of 28 healthy , postmenopausal women randomly assigned to receive two SCE-B 0.3-mg tablets or one 1.25-mg tablet daily for 14 days .
METHODS	Blood samples were obtained before and after dosing at designated times .
METHODS	Total ( conjugated and free ) and unconjugated estrogens , namely estrone , equilin , and delta8,9-DHE , were determined , and pharmacokinetic analysis was performed .
RESULTS	Steady-state plasma levels of total estrone and total delta8,9-DHE measured on day 14 over a 24-hour period showed minor fluctuations and a similar time to maximum concentration ( Tmax ) : mean Tmax of total estrone = 7.94 and 8.36 hours for 0.3-mg and 1.25-mg tablets , respectively ; mean Tmax of total delta8,9-DHE = 7.08 and 8.36 hours for 0.3-mg and 1.25-mg tablets , respectively .
RESULTS	Consistency in pharmacokinetic parameters was seen between the two doses of SCE-B .
CONCLUSIONS	SCE-B 0.3-mg and SCE-B 1.25-mg tablets achieved consistent pharmacokinetic parameters and steady-state levels when administered to healthy postmenopausal women .
CONCLUSIONS	Achieving smooth , predictable levels of component estrogens may result in more consistent relief of menopausal symptoms .

###23578427
OBJECTIVE	To study the clinical effect of arthroscopic anterior cruciate ligament ( ACL ) construction with different transplants .
METHODS	From March 2006 to April 2009 , 86 patients including 60 male and 26 female undergoing arthroscopic ACL reconstruction were prospectively randomized consecutively into autograft group ( 44 patients , using autogeneic hamstring tendons ) and allograft group ( 42 patients , using allogenic lower extremity tendons ) .
METHODS	The age of those patients were 22 - 56 years , averaging ( 32 7 ) years .
METHODS	The operations were made by the same doctor with the standard technology .
METHODS	The postoperative effects were assessed by the range of motion and tibia forward distance , Lachman test , pivot shift test , Daniel test , IKDC scores systems , Lysholm-Tegner scores .
RESULTS	Seventy-nine patients were followed up , 41 patients in autograft groups averaged 39.6 months and 38 patients in allograft group averaged 37.4 months .
RESULTS	The operation time of autograft group was ( 87 11 ) minutes , that of allograft group was ( 55 10 ) minutes ( t = 15.732 , P < 0.05 ) .
RESULTS	The time of postoperative fever of autograft group was ( 3.2 1.4 ) days , that of allograft groups was ( 7.6 5.3 ) days ( t = 5.740 , P < 0.05 ) .
RESULTS	The Lysholm scores of autograft group was 42 7 before operation , and 89 8 at final follow-up .
RESULTS	The Lysholm scores of allograft group was 44 6 before operation , and 87 9 at final follow-up .
RESULTS	There was statistic difference in both groups between before operation and final follow-up ( t = 13.534 and 17.768 , P < 0.05 ) .
RESULTS	But no statistic difference existed between the two groups ( P > 0.05 ) .
RESULTS	The Tegner scores of autograft group was 2.9 2.1 before operation , and 7.7 1.2 at final follow-up .
RESULTS	The Tegner scores of allograft group was 2.7 1.4 before operation , and 7.1 1.6 at final follow-up .
RESULTS	There was statistic difference in both groups between before operation and final follow-up ( t = 16.004 and 12.338 , P < 0.05 ) .
RESULTS	No statistic difference existed between the two groups ( P > 0.05 ) .
RESULTS	The KT2000 results showed that the anterior displacement of autograft groups was ( 10.7 3.5 ) mm before operation and ( 5.0 2.7 ) mm at final follow-up , the anterior displacement of allograft groups was ( 10.9 2.9 ) mm before operation and ( 6.5 2.4 ) mm at final follow-up , there was statistic difference between before and after operation in anterior displacement in two groups ( t = 16.354 and 13.296 P < 0.05 ) .
RESULTS	There was no difference between two groups before operation and at final follow-up .
RESULTS	Compared to before operation , the IKDC scores were improved greatly after operation ( P < 0.05 ) .
CONCLUSIONS	The clinical effect of arthroscopic ACL construction with allograft transplants is near to autograft .

###19681774
BACKGROUND	The objective of this study was to evaluate the influence of single vs. dual control during an ultrasound-guided lateral sagittal infraclavicular block on the efficacy of sensory block and the time of block onset .
METHODS	In a prospective manner , 60 adult patients scheduled for distal upper limb surgery were randomly allocated to single ( Group S ) or double stimulation ( Group D ) groups .
METHODS	A local anesthetic ( LA ) mixture of 20 ml of levobupivacaine 5 mg/ml and 20 ml of lidocaine 20 mg/ml with 5 microg/ml epinephrine ( total 40 ml ) was administered in both groups .
METHODS	In the Group S following a median , an ulnar or a radial nerve response , the entire LA was administered at a single site .
METHODS	In Group D 10 ml of LA was administered following the electrolocation of the musculocutaneous nerve and 30 ml LA was injected following median , ulnar or radial nerves .
METHODS	A successful block was defined as analgesia or anesthesia of all five nerves distal to the elbow .
METHODS	Sensory and motor blocks were tested at 5-min intervals for 30 min .
RESULTS	The block was successful in 27 patients in Group S and 28 patients in Group D.
RESULTS	The time from starting the block until satisfactory anesthesia was significantly shorter in Group D than in Group S ( 19.3 vs. 23.2 min ) ( P < 0.05 ) .
RESULTS	Total sensory scores were significantly higher in the double stimulation group at 20 and 30 min after the block performance ( P < 0.05 ) .
CONCLUSIONS	Although the block performance time was longer in the double stimulation group , block onset time and extent of anesthesia were more favorable in the double stimulation group .

###8925581
BACKGROUND	Although trials of amiodarone therapy in patients with congestive heart failure have produced discordant results with regard to effects on survival , most studies have reported a significant rise in left ventricular ejection fraction during long-term therapy .
BACKGROUND	In the present study , we determined whether this increase in ejection fraction is associated with an improvement in the symptoms and/or physical findings of heart failure or a reduction in the number of hospitalizations for heart failure .
RESULTS	In the Department of Veterans Affairs cooperative study of amiodarone in congestive heart failure , 674 patients with New York Heart Association class II through IV symptoms and ejection fractions of < or = 40 % were treated with amiodarone or placebo for a median of 45 months in a randomized , double-blind , placebo-controlled protocol .
RESULTS	Clinical assessments and radionuclide ejection fraction were performed at baseline and after 6 , 12 , and 24 months .
RESULTS	Compared with the placebo group , ejection fraction increased more in the amiodarone group at each time point ( 8.1 + / - 10.2 % [ mean + / - SD ] versus 2.6 + / - 7.9 % at 6 months , 8.0 + / - 10.9 % versus 2.7 + / - 8.0 % at 12 months , and 8.8 + / - 10.1 % versus 1.9 + / - 9.4 % after 24 months , all P < .001 ) .
RESULTS	However , this difference was not associated with greater clinical improvement , lesser diuretic requirements , or fewer hospitalizations for heart failure ( 11.1 % for amiodarone and 13.6 % for placebo group ; overall relative risk in the amiodarone group , 0.81 [ 95 % CI , 0.56 to 1.10 ] , P = .18 ) .
RESULTS	Of note is the trend toward a reduction in the combined end point of hospitalizations and cardiac deaths ( relative risk , 0.82 [ CI , 0.65 to 1.03 ] , P = .08 ) , which was significant in patients with nonischemic etiology ( relative risk , 0.56 [ CI , 0.36 to 0.87 ] , P = .01 ) and absent in the ischemic group ( relative risk , 0.95 ) .
CONCLUSIONS	Although amiodarone therapy resulted in a substantial increase in left ventricular ejection fraction in patients with congestive heart failure , this was not associated with clinical benefit in the population as a whole .
CONCLUSIONS	The substantial reduction in the combined end point of cardiac death plus hospitalizations for heart failure in the nonischemic group suggests possible benefit in these patients .

###16885989
BACKGROUND	Inadequate nutrition leading to growth failure is common among premature infants .
BACKGROUND	Although fortified breast milk ( breast milk plus commercially prepared fortifier ) is the preferred feeding , nutrient intakes achieved with fortified breast milk fall short of meeting nutrient needs .
BACKGROUND	This is mainly due to inadequate protein content of fortifiers and variability in composition of expressed breast milk .
OBJECTIVE	A new adjustable fortification regimen has been designed to ensure that protein needs of premature infants are met at all times .
OBJECTIVE	The new regimen encompasses increasing the amount of fortifier and adding extra protein to breast milk guided by periodic determinations of blood urea nitrogen ( BUN ) .
OBJECTIVE	The study tested the hypothesis that infants fed according to the new regimen have higher protein intakes and improved weight gain compared to infants fed according to standard fortification regimen .
METHODS	In a prospective , controlled trial , preterm infants with birth weights of 600-1750 g and gestational ages between 26 and 34 weeks were fed their own mother 's milk or banked donor milk or both .
METHODS	Infants were randomly assigned before 21 days of age to either the new adjustable fortification regimen or the standard regimen .
METHODS	The study period began when feeding volume reached 150 ml/kg/day and ended when infants reached a weight of 2000 g. Standard fortification ( STD ) consisted in the use of the recommended amount of fortifier .
METHODS	Adjustable fortification ( ADJ ) consisted in the use , in addition to standard fortification , of extra fortifier and supplemental protein guided by twice-weekly BUN determinations .
METHODS	The primary outcome was weight gain , with serum biochemical indicators and nutrient intakes as secondary outcomes .
RESULTS	Thirty-two infants completed the study as planned ( 16 ADJ , 16 STD ) .
RESULTS	Infants receiving the ADJ regimen had mean protein intakes of 2.9 , 3.2 and 3.4 g/kg/day , respectively , in weeks 1 , 2 and 3 , whereas infants receiving the STD regimen had intakes of 2.9 , 2.9 , 2.8 g/kg/day , respectively .
RESULTS	Infants on the ADJ regimen showed significantly greater gain in weight ( 17.5 + / -3.0 vs 14.4 + / -3.0 g/kg/day , P < 0.01 ) and greater gain in head circumference ( 1.4 + / -0.3 vs 1.0 + / -0.3 ; P < 0.05 ) than infants on the STD regimen .
RESULTS	Weight and head circumference gain were significantly ( P < 0.05 ) correlated with protein intake .
RESULTS	No significant correlations were found between growth parameters and intake of fat and energy .
RESULTS	There were no significant differences between groups in BUN and other serum chemical values .
RESULTS	In the ADJ group , BUN concentrations increased significantly ( P < 0.001 ) over time but were not significantly higher than in the STD group .
CONCLUSIONS	Premature infants managed with the new adjustable fortification regimen had significantly higher weight and head circumference gains than infants managed with standard fortification .
CONCLUSIONS	Higher protein intake appears to have been primarily responsible for the improved growth with the adjustable regimen .
CONCLUSIONS	The new fortification method could be a solution to the problem of protein undernutrition among premature infants fed human milk .

###15864233
BACKGROUND	C-reactive protein ( CRP ) levels are associated with cardiovascular risk .
BACKGROUND	We assessed the hypothesis that atorvastatin might have anti-inflammatory effects in acute coronary syndromes ( ACS ) as shown by CRP reduction .
METHODS	This study was a prospective , randomized , double-blind , placebo-controlled study of 90 consecutive patients admitted within 48 hours of onset of ACS with CRP levels > or = 1.4 mg/dL .
METHODS	Patients were assigned to atorvastatin 40 mg daily or placebo over 30 days .
METHODS	C-reactive protein levels , lipid profiles , serum fibrinogen , white cell count , and erythrocyte sedimentation rate were measured at entry , hospital discharge , and 1 month later .
RESULTS	Baseline clinical characteristics did not differ between atorvastatin and placebo groups ( mean age 59.3 + / - 13.4 vs 61.1 + / - 11.5 , P = ns ) ; myocardial infarction 52.3 % versus 67.4 % ( P = ns ) .
RESULTS	In both groups , median baseline CRP levels were comparable ( 5.97 + / - 6.2 vs 4.64 + / - 4.2 mg/dL , P = ns ) .
RESULTS	C-reactive protein levels were lower in the atorvastatin group versus control group at discharge ( 1.68 + / - 1.65 vs 4.12 + / - 4.18 mg/dL ) and at 30 days ( 0.50 + / - 0.71 vs 2.91 + / - 2.68 mg/dL , both P < .0001 ) .
RESULTS	C-reactive protein levels significantly decreased from baseline to discharge and 1 month later in placebo and atorvastatin groups ( both P < .0001 ) ; however , the reduction was greater in the atorvastatin group ( 62 % vs 11 % at discharge [ P < .0001 ] ; 84 % vs 30 % at 1 month [ P < .0001 ] ) .
RESULTS	In addition , atorvastatin was associated with a reduction in total and low-density lipoprotein cholesterol and erythrocyte sedimentation rate at discharge and at 30 days ( P < .0001 for all comparisons ) .
RESULTS	No correlation was found between changes in CRP and cholesterol levels .
CONCLUSIONS	C-reactive protein levels in ACS were rapidly reduced with atorvastatin .
CONCLUSIONS	These data provide evidence that statins have fast and early anti-inflammatory effects in addition to lipid-lowering effects in ACS .

###23826087
BACKGROUND	Cutaneous leishmaniasis ( CL ) is a neglected infectious disease and a major health problem in several developing countries .
BACKGROUND	Despite some reasonable explanation for their potential benefits , there is only trace evidence regarding the role of dressings in the treatment of CL .
METHODS	This randomized , assessor-blind , controlled , clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intralesional meglumine antimoniate ( i.l.MA ) either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks .
METHODS	After screening of 241 patients with CL lesions , 83 eligible patients with 158 lesions were randomly allocated in three arms of the study .
METHODS	Eligibility criteria included parasitologically confirmed CL , age of 12 to 60 years ; willingness to participate , duration of lesion < 3 months , number of lesions < 5 , largest ulcer diameter < 5 cm .
METHODS	Pregnant or lactating women were excluded .
METHODS	The primary outcome was absolute risk reduction ( ARR ) based on the proportion of complete healing , which was defined as more than 75 % reduction in the size of the lesion compared with baseline in each group at the termination of treatment and 1 month later .
RESULTS	ARR ( 95 % Confidence Interval [ CI ] ) in i.l.MA versus i.l.MA + non-silver dressing groups was 5.98 % ( -7.07 % to 20.25 % ) , between i.l.MA versus i.l.MA + silver dressing groups was -0.23 % ( -13.53 % to 14.82 % ) , and between i.l.MA + non-silver dressing versus i.l.MA + silver dressing groups was -6.21 % ( -18.28 % to 6.52 % ) after 6 weeks of treatment .
RESULTS	ARR ( 95 % CI ) in i.l.MA versus i.l.MA + non-silver dressing groups was -2.22 % ( -22.12 % to 18.10 % ) , between i.l.MA versus i.l.MA + silver dressing groups was 3.64 % ( -15.36 % to 22.82 % ) , and between i.l.MA + non-silver dressing versus i.l.MA + silver dressing groups was 5.86 % ( -12.86 % to 24.31 % ) 1 month later .
CONCLUSIONS	It could not be demonstrated that the efficacy of i.l.MA was improved by either dressing .
BACKGROUND	Iranian Registry of Clinical Trials ( IRCT.ir ) IRCT138707201166N2 .

###16685054
BACKGROUND	Iron supplements are often prescribed during pregnancy despite the lack of intervention trials that have assessed the effects of supplementation in pregnancy on childhood development .
OBJECTIVE	The objective was to determine whether iron supplementation during pregnancy influences childhood intelligence quotient ( IQ ) in an industrialized country .
METHODS	Pregnant women ( n = 430 ) were randomly allocated to receive iron ( 20 mg/d ) or placebo from 20 wk gestation until delivery , and the women and their children were followed up over the long term ( 4 y ) .
METHODS	Seventy percent of these families participated in the follow-up .
METHODS	The proportion of women with iron deficiency anemia at the end of pregnancy was 1 % ( 2 of 146 ) in the iron group and 11 % ( 15 of 141 ) in the placebo group .
METHODS	The primary outcome was the IQ of the children at 4 y of age , as assessed by the Stanford-Binet Intelligence Scale .
METHODS	Secondary outcomes included child behavior and the general health of the mothers .
RESULTS	The mean IQ was not significantly different ( P = 0.980 ) between the children of the iron-supplemented mothers ( 109 + / - 11 ; n = 153 ) and the children of the mothers in the placebo group ( 109 + / - 11 ; n = 149 ) .
RESULTS	However , the percentage of children with an abnormal behavior score was higher in the iron group ( 24 of 151 , or 16 % ) than in the placebo group ( 12 of 149 , or 8 % ) ; the relative risk was 1.97 ( 95 % CI : 1.03 , 3.80 ; P = 0.037 ) .
RESULTS	There was no significant difference in the health of the mothers between groups , as assessed by the SF-36 Health Survey .
CONCLUSIONS	Prenatal iron supplementation that reduces the incidence of iron deficiency anemia from 11 % to 1 % has no effect on the IQ of the offspring at 4 y of age .

###20237046
BACKGROUND	Sore throat is a common complication after surgery .
BACKGROUND	Postoperative cough and hoarseness can also be distressing to patients .
BACKGROUND	We sought to determine the effect of an inhaler steroid on sore throat , cough , and hoarseness during the first 24 hours of the postoperative period .
METHODS	We enrolled 120 women with ASA physical status I or II and term singleton pregnancy who were scheduled for elective cesarean delivery under general anesthesia .
METHODS	Patients were randomized into 2 groups : in the sitting position , group F patients received 500 g inhaled fluticasone propionate via a spacer device during 2 deep inspirations , after arrival in the operating room , and group C had no treatment .
METHODS	The patients were interviewed by a blinded investigator for postoperative sore throat , cough , and hoarseness at 1 and 24 hours after surgery .
RESULTS	There were no significant differences in age , height , weight , body mass index , duration of surgery , intubation , and grade of laryngeal exposure between the 2 groups .
RESULTS	The incidence of sore throat , cough , and hoarseness was significantly lower in group F ( 3.33 % , 3.33 % , and 3.33 % ) compared with the control group ( 36.67 % , 18.33 % , and 35 % ) ( P < 0.05 for all comparisons ) , not only in the first postoperative hour but also 24 hours after surgery ( 13.33 % , 13.33 % , and 25 % in group F vs 40 % , 41.67 % , and 50 % in the control group ) .
RESULTS	The incidence of moderate and severe hoarseness in group F at the first hour was significantly less than the control group ( P < 0.05 ) .
CONCLUSIONS	Inhaled fluticasone propionate decreases the incidence and severity of postoperative sore throat , cough , and hoarseness in patients undergoing cesarean delivery under general anesthesia .

###12576870
OBJECTIVE	We examined the effects of atrasentan ( endothelin-A receptor antagonist ) on bone deposition and resorption markers and on bone scan index .
METHODS	This double-blind , randomized , placebo controlled clinical trial of hormone refractory prostate cancer patients was done at 74 medical centers in the United States and Europe .
METHODS	A total of 288 asymptomatic patients with hormone refractory prostate adenocarcinoma and evidence of metastatic disease were randomized to 1 of 3 treatment groups , namely 2.5 mg .
METHODS	atrasentan , 10 mg .
METHODS	atrasentan or placebo administered orally daily until disease progression .
METHODS	The main outcomes measures were changes in bone deposition markers ( total alkaline phosphatase and bone alkaline phosphatase ) and bone resorption ( N-telopeptides , C-telopeptides and deoxypyridinoline ) , and in the bone scan index .
RESULTS	At baseline markers of bone deposition and resorption were elevated 1.4 to 2.7-fold above respective upper limits of normal .
RESULTS	Subjects receiving placebo experienced a 58 % elevation in mean total alkaline phosphatase and a 99 % elevation in mean bone alkaline phosphatase ( p < 0.001 ) , whereas subjects receiving 10 mg .
RESULTS	atrasentan maintained stable mean total alkaline phosphatase and bone alkaline phosphatase values compared with baseline .
RESULTS	N-telopeptides , C-telopeptides and deoxypyridinoline elevation from baseline were consistently less in patients receiving 10 mg .
RESULTS	atrasentan compared with placebo .
RESULTS	Similar trends were observed in subjects who received 2.5 mg .
RESULTS	atrasentan .
RESULTS	Changes in clinical bone scan studies paralleled bone marker changes .
CONCLUSIONS	Atrasentan suppressed markers of biochemical and clinical prostate cancer progression in bone and demonstrates clinical activity for hormone refractory prostate cancer .

###19447770
OBJECTIVE	To assess the efficacy of rituximab ( RTX ) in SSc .
METHODS	Fourteen patients with SSc were evaluated .
METHODS	Eight patients were randomized to receive two cycles of RTX at baseline and 24 weeks [ each cycle consisted of four weekly RTX infusions ( 375 mg/m ( 2 ) ) ] in addition to standard treatment , whereas six patients ( control group ) received standard treatment alone .
METHODS	Lung involvement was assessed by pulmonary function tests ( PFTs ) and chest high-resolution CT ( HRCT ) .
METHODS	Skin involvement was assessed both clinically and histologically .
RESULTS	There was a significant increase of forced vital capacity ( FVC ) in the RTX group compared with baseline ( mean + / - s.d. : 68.13 + / - 19.69 vs 75.63 + / - 19.73 , at baseline vs 1-year , respectively , P = 0.0018 ) .
RESULTS	The median percentage of improvement of FVC in the RTX group was 10.25 % , whereas that of deterioration in the controls was 5.04 % ( P = 0.002 ) .
RESULTS	Similarly , diffusing capacity of carbon monoxide ( DL ( CO ) ) increased significantly in the RTX group compared with baseline ( mean + / - s.d. : 52.25 + / - 20.71 vs 62 + / - 23.21 , at baseline vs 1-year respectively , P = 0.017 ) .
RESULTS	The median percentage of improvement of DL ( CO ) in the RTX group was 19.46 % , whereas that of deterioration in the control group was 7.5 % ( P = 0.023 ) .
RESULTS	Skin thickening , assessed with the Modified Rodnan Skin Score ( MRSS ) , improved significantly in the RTX group compared with the baseline score ( mean + / - s.d. : 13.5 + / - 6.84 vs 8.37 + / - 6.45 at baseline vs 1-year , respectively , P < 0.001 ) .
CONCLUSIONS	Our results indicate that RTX may improve lung function in patients with SSc .
CONCLUSIONS	To confirm our encouraging results we propose that larger scale , multicentre studies with longer evaluation periods are needed .

###21234866
BACKGROUND	Toxicity is a major problem for patients undergoing intravesical therapy with Bacillus Calmette-Gurin ( BCG ) for the conservative management of intermediate or high-risk non-muscle invasive bladder cancer ( NMI-BC ) .
BACKGROUND	A prospective pilot trial was designed to evaluate the adoption of a single dose of prulifloxacin to prevent the toxicity of BCG .
BACKGROUND	Treatment tolerability and its possible influence on BCG efficacy have been analyzed .
METHODS	The study was designed to evaluate the action of prulifloxacin in patients with intermediate or high-risk NMI-BC , undergoing 6-week induction cycle of BCG .
METHODS	Main exclusion criteria were previous intravesical therapy , urinary infection and any other factor that could influence tolerability to BCG intravesical immunotherapy .
METHODS	The patients were randomized to receive BCG alone versus BCG plus prulifloxacin .
METHODS	BCG toxicity and local tolerability were evaluated by self-administered EORTC QLQ-BLS24 questionnaire , and BCG adverse events ( AEs ) were classified according a four-class classification .
METHODS	The toxicity and tolerability evaluations were performed at baseline , one week after every instillation and one week and one month after the last instillation .
METHODS	Cystoscopy and cytology were performed 3-monthly .
METHODS	Recurrence and progression were recorded .
RESULTS	The study included 43 patients receiving 258 instillations of BCG .
RESULTS	The patients were randomized to receive BCG alone ( Arm A : 132 instillations in 22 patients ) versus BCG plus prulifloxacin given as a single oral dose ( 600 mg ) 6 hours after the instillation .
RESULTS	An advantage in favor of prulifloxacin prophylaxis emerged , according to EORTC QLQ-BLS24 , in overall incidence of nocturnal micturitions ( 56 % vs 28.6 % ; p = 0.001 ) , insomnia ( 40 % vs 14.3 % ; p = 0.002 ) , urgency ( 70 % vs 42.6 % ; p = 0.05 ) , incontinence ( 44 % vs 12.7 % ; p = 0.01 ) and bothersome events due to intravesical therapy ( 84 % vs 63.5 % ; p = 0.02 ) .
RESULTS	Systemic class IIB and III adverse events occurred in only 14.2 % and 3.5 % of the patients , respectively .
RESULTS	No class IV AE was detected .
RESULTS	Due to the low incidence no statistically significant difference was evident between the two arms ( p = 0.6 ) .
RESULTS	Three patients of Arm B and 1 patient of Arm A interrupted the treatment , after the 3rd - 4th instillation .
RESULTS	Anti-tuberculosis therapy war required for 3 months in only one patient .
RESULTS	Three and 2 instillations were postponed for one - ( two ) week ( s ) in Arm B and Arm A , respectively .
RESULTS	Prulifloxacin , generally well tolerated , was withdrawn in one patient due to skin allergic reaction .
RESULTS	Recurrence rate at a mean follow-up of 12 months did not significantly differ between the two arms .
CONCLUSIONS	Prulifloxacin decreases the incidence of local symptoms and improves the compliance to BCG intravesical therapy .
CONCLUSIONS	Due to the low number of events , no evidence emerges in our study about its capability of preventing severe systemic toxicity , although it has proved effective in reducing local symptoms .

###24848812
OBJECTIVE	The purpose of this study was to compare the performance of a 20-gauge fenestrated catheter with an 18-gauge nonfenestrated catheter for i.v. contrast infusion during MDCT .
METHODS	Two hundred five adult outpatients imaged on a dual-source 128-MDCT scanner with arterial phase body CT ( flow rates , 5.0-7 .5 mL/s ) were randomized to either an 18-gauge nonfenestrated or 20-gauge fenestrated catheter .
METHODS	After randomization , any 18-gauge nonfenestrated subjects whose veins were deemed insufficient for that catheter gauge were assigned to a third cohort for placement of a 20-gauge fenestrated catheter .
METHODS	Catheter placement success , infusion rate , contrast volume , maximum pressure , complications , and aortic enhancement levels were recorded .
RESULTS	Catheters were placed on the first attempt in 97 % ( 100/103 ) for 18-gauge nonfenestrated and 94 % ( 96/102 ) for 20-gauge fenestrated placements and in two or fewer attempts in 99 % of both groups .
RESULTS	Mean infusion rates ( 5.74 mL/s for 18-gauge nonfenestrated and 5.58 mL/s for 20-gauge fenestrated placements ) and aortic enhancement levels were not significantly different .
RESULTS	Maximum pressure was higher with 20-gauge fenestrated catheters ( mean SD , 230.5 27.6 pounds per square inch [ psi ] ) than 18-gauge nonfenestrated catheters ( mean SD 215.6 32.8 psi ) ( p = 0.002 ) .
RESULTS	One subject with an 18-gauge nonfenestrated catheter had a high-pressure alarm .
RESULTS	In the third cohort , a 20-gauge fenestrated catheter was successfully placed in two or fewer attempts in 85 % ( 28/33 ) , with one minor extravasation attributed to vein insufficiency .
CONCLUSIONS	A 20-gauge fenestrated catheter performs similarly to an 18-gauge nonfenestrated catheter with respect to i.v. contrast infusion rates and aortic enhancement levels and can be placed in most subjects whose veins are deemed insufficient for an 18-gauge catheter .

###24557105
BACKGROUND	In the last 2 decades , the effectiveness of cricoid pressure ( CP ) in occluding the esophageal entrance has been questioned .
BACKGROUND	Recent magnetic resonance imaging studies yielded conflicting conclusions .
BACKGROUND	We used real-time visual and mechanical means to assess the patency of the esophageal entrance with and without CP in anesthetized and paralyzed adult patients .
METHODS	One hundred seven , nonobese ASA physical status I and II patients were recruited for the study .
METHODS	A cricoid force of 30 N was used .
METHODS	This force was standardized by using a weighing scale before application of CP in each patient .
METHODS	After oxygen administration , anesthetic induction , neuromuscular blockade , and establishment of manual ventilation with FIO2 = 1.0 , the view of the glottis and esophageal entrance was visualized , and video recordings were obtained by using a Glidescope video laryngoscope .
METHODS	Attempts to insert 2 gastric tubes ( GTs ) , size 12 and 20 F , into the esophagus were made by a `` blinded '' operator without and with CP , the timing of which was randomized .
METHODS	A successful insertion of a GT in the presence of CP was considered evidence of a patent esophageal entrance ( ineffective CP ) , whereas an unsuccessful insertion of a GT was considered evidence of an occluded esophageal entrance ( effective CP ) .
METHODS	After the attempts to insert the GTs were completed , tracheal intubation was performed while CP was applied .
METHODS	The position of the esophageal entrance in relation to the glottis ( midline versus lateral ) was assessed from the video recordings , with and without CP .
RESULTS	We stopped the study when 79 patients ( 41 men and 38 women ) qualified for and completed the study ( 2-sided Clopper-Pearson confidence interval ( CI ) 95 % to 100 % , n = 72 ) .
RESULTS	Advancement of either size GT into the esophagus could not be accomplished during CP in any patient but was easily done in all subjects when CP was not applied .
RESULTS	This occurred whether the esophageal entrance was in a midline position or in a left or right lateral position relative to the glottis .
RESULTS	Esophageal patency was visually observed in the absence of CP , whereas occlusion of the esophageal entrance was observed during CP in all patients .
RESULTS	Without CP , the esophageal entrance was in a left lateral position in relation to the glottis in 57 % ( [ 95 % CI , 45 % -68 % ) ] of patients , at midline in 32 % ( CI , 22 % -43 % ) , and in a right lateral position in 11 % ( CI , 5 % -21 % ) .
RESULTS	The position did not change with CP .
CONCLUSIONS	The current study provides additional visual and mechanical evidence supporting a success rate of at least 95 % by using a cricoid force of 30 N to occlude the esophageal entrance in anesthetized and paralyzed normal adult patients .
CONCLUSIONS	The efficacy of the maneuver was independent of the position of the esophageal entrance relative to the glottis , whether midline or lateral .

###21719715
BACKGROUND	Optimal utilization of health care resources for patients with chronic conditions is an increasing focus of health care policy researchers and clinicians .
BACKGROUND	Kidney disease , diabetes ( DM ) and cardiovascular disease ( CVD ) often coexist within one individual , but current systems are designed to manage individual conditions .
BACKGROUND	We sought to examine if streamlining medical care of complex patients ( two or more conditions ) is associated with similar , worse or improved outcomes using a randomized controlled study design .
METHODS	Patients attending a kidney care clinic ( KCC ) and at least one other specialty clinic of interest ( DM , CVD ) were randomly assigned to either the ` combined clinic ( CC ) ' arm , where resources from all three were integrated into one clinic , or to the ` standard care ' arm with continued attendance at multiple specialty clinics ( MC ) , including the KCC .
METHODS	The primary outcome was hospitalization rate and sample size was calculated based on non-inferiority .
RESULTS	Of 150 subjects enrolled , 11 subjects exited before study commencement : 139 remained for final analysis .
RESULTS	Other than older age in the MC group ( P = 0.009 ) , the demographics were comparable .
RESULTS	Hospitalization rates were not different ( 95 % CI for the difference : 0.013-0 .207 ; P = 0.03 ) .
RESULTS	Similar proportions in each group achieved clinical and laboratory targets .
RESULTS	Mortality ( 13 % ) and dialysis ( 32 % ) rates were the same between groups .
RESULTS	Differences in the cost of clinic visits alone were $ 86,400 per year in favor of the CC .
CONCLUSIONS	Medical care of complex patients may be delivered in a single combined specialty clinic as compared to multiple disease specific clinics without compromising patient care or important health outcomes , with demonstrable outpatient costs savings .

###11407289
BACKGROUND	The EEG-Bispectral Index ( BIS ) is a processed EEG information that has been validated as a means to measure the hypnotic effect of anesthetic drugs .
BACKGROUND	In this study we evaluated the BIS changes in induction of anesthesia with ketamine in comparison with that of thiamylal .
METHODS	Forty ASA class I and II adult female patients undergoing elective gynecologic surgeries were enrolled into this randomized , prospective study .
METHODS	No premedication was given to the patient .
METHODS	In each patient EEG was recorded continuously from the frontal electrodes using Aspect A-1050 monitor after his arrival at the operating room .
METHODS	Blood pressure and heart rate were also recorded throughout the surgery .
METHODS	After steady baseline recordings of all necessary parameters having been accomplished Group K patients ( n = 20 ) were given an induction dose of ketamine 1.5 mg/kg i.v. , whereas Group T patients ( n = 20 ) received thiamylal 5 mg/kg i.v.
METHODS	When loss of consciousness was ascertained , intubation was performed after administration of succinylcholine 1 mg/kg i.v. and anesthesia was maintained with isoflurane-nitrous oxide-oxygen .
METHODS	Demographics , BIS values , HR , BP were analyzed and compared .
RESULTS	The demographics were comparable between the two groups .
RESULTS	Both groups showed a mean value of BIS of 96 with comparable BP and HR before induction .
RESULTS	After study drug the post-induction BIS for ketamine was 94 as against 51 for thiamylal ( P < 0.05 ) , 91 against 43 post-succinylcholine ( P < 0.05 ) , 92 against 53 post-intubation ( P < 0.05 ) and 45 against 37 five min after isoflurane .
RESULTS	BIS remained below 60 throughout the entire course of anesthesia and returned to above 95 on emergence in both groups .
RESULTS	None of the patients reported awareness , recall , delirium or hallucination during anesthesia .
CONCLUSIONS	Ketamine-induced dissociative anesthesia produces persistently elevated BIS index which is different from thiamylal and those reported with other conventional anesthetic agents .
CONCLUSIONS	The established range of BIS index appears not to be applicable in patients under ketamine anesthesia .
CONCLUSIONS	Monitoring the depth of ketamine anesthesia remains to be a challenging problem .

###17404897
OBJECTIVE	There is a call for a further investigation of Sense of Coherence ( SOC ) , the central concept in salutogenesis , and its relation to health and life satisfaction .
OBJECTIVE	No previous studies have investigated the utility of SOC versus mental symptoms for the prediction of life satisfaction among people with chronic mental health problems ( MHP ) .
METHODS	The present study has a prospective design including a baseline assessment and a 1-year follow up .
METHODS	We recruited 107 adults from the community health care system .
METHODS	SOC was measured by the Sense of Coherence questionnaire , mental symptoms by the Symptom Checklist-90 revised and life satisfaction by The Quality of Life Scale ( all Norwegian versions ) .
RESULTS	The results show that while SOC predicts change in life satisfaction ( standardized beta coefficient for SOC was 0.39 , P = 0.014 ) , mental symptoms did not ( standardized beta coefficient 0.00 , P = 1.0 ) .
CONCLUSIONS	These findings emphasize the importance of assessing factors that may explain differences in life satisfaction over and above mental symptoms among people with MHP .
CONCLUSIONS	The results indicate that improving SOC among people with MHP might provide important opportunities for improving their life satisfaction .

###7633972
OBJECTIVE	To study the effect of long-term treatment of the platelet inhibitor ticlopidine as secondary prevention against the need of vascular surgery in patients with intermittent claudication .
METHODS	The Swedish Ticlopidine Multicentre Study ( STIMS ) , was conducted in six medical and surgical clinics of university hospitals in Sweden .
METHODS	687 claudicants were randomised to ticlopidine 250 mg bd or placebo and vascular surgery events were recorded prospectively over a 7-year period .
METHODS	Cox proportional hazards models of risk for leg vascular surgery were constructed using drug treatment and 11 putative risk factors for vascular disease as covariates .
METHODS	Surgical event-free survivals were compared by Kaplan-Meier analysis .
RESULTS	The overall rate of first operations was 2.4 % per annum .
RESULTS	More than half of these operations were in the aortoiliac region .
RESULTS	One-quarter of patients operated during the period required further operations but amputation was rare .
RESULTS	Ticlopidine treatment reduced the need for vascular reconstructive surgery by about half , both in intention-to-treat and on-treatment analyses ( unadjusted relative risks 0.486 , 95 % CI 0.317-0 .745 ; p < 0.001 ; 0.493 , 95 % CI 0.290-0 .841 : p < 0.01 , respectively ) .
RESULTS	In Cox model analysis only male sex was confirmed as a risk factor for surgery .
RESULTS	Previous peripheral arterial surgery was the strongest predictor of the need for surgery .
RESULTS	None of the risk factors examined interacted statistically with the effect of treatment with ticlopidine .
CONCLUSIONS	In patients with intermittent claudication it seems possible to prevent the need for future vascular surgery by the use of platelet inhibition with ticlopidine .

###19845100
BACKGROUND	A standard treatment option for carpal tunnel syndrome ( CTS ) is local injection of anesthetic-corticosteroid .
BACKGROUND	This clinical trial was designed to compare the safety and efficacy of daily application of the EMLA cream ( lidocaine 2.5 % plus prilocaine 2.5 % ) with that of a single injection of methyl prednisolone acetate ( Depo-Medrol ) 40 mg .
METHODS	In this randomized , parallel-group , open-label , single-center , case-controlled , prospective study , 65 participants ( 70 hands ) aged 18-75 years with clinical & electrodiagnostic evidences of CTS were randomized to receive either the EMLA cream ( n = 30 patients , 35 hands , group 1 ) or one injection of methylprednisolone acetate 40 mg at wrist ( n = 35 patients , group 2 ) .
METHODS	Outcome assessments included the visual analog scale and clinical assessment .
RESULTS	After 4 weeks of treatment , patients in both groups reported significant changes ( P < 0.001 ) in pain intensity .
RESULTS	Both treatments were well tolerated , with treatment-related adverse events ( AEs ) reported in 2 patients in group 1 ( 5.7 % ) and 10 patients in group 2 ( 28.5 % ) No systemic treatment-related AEs were observed with the EMLA cream .
CONCLUSIONS	EMLA cream was effective in reducing pain associated with CTS and well tolerated and it may offer patients with CTS an effective , noninvasive symptomatic treatment .

###21305227
OBJECTIVE	This study aimed to assess short-term effects of botulinum toxin A in ambulant adults with spastic cerebral palsy .
METHODS	A single-centre double-blind , placebo-controlled , randomized clinical trial .
METHODS	Patients were recruited through advertisements .
METHODS	Inclusion criteria were : spastic cerebral palsy , age 18-65 years , decreased walking , walking without aids for minimum 20 m , and no cognitive impairments .
METHODS	A total of 66 participants , mean age 37 ( standard deviation 11.4 ) years , were enrolled and received injections of either botulinum toxin A ( n = 33 ) or placebo ( n = 33 ) .
METHODS	Primary outcomes were : sagittal kinematics of ankle , knee and hip , and health-related quality of life ( Short Form 36 ) .
METHODS	Secondary outcomes were : visual analogue scale for muscle-stiffness/spasticity , Timed Up and Go , 6-minute walk test , and Global Scale of perceived effect .
RESULTS	No significant differences were found between the groups in the primary outcomes .
RESULTS	In the secondary outcomes the botulinum toxin A group rated improvement in visual analogue scale muscle-stiffness/spasticity and the Global Scale of perceived effect .
RESULTS	No serious adverse events occurred .
CONCLUSIONS	Botulinum toxin A injections alone gave no benefit over placebo in lower limb sagittal kinematics and Short Form 36 in ambulatory adults with cerebral palsy .
CONCLUSIONS	However , self-reported rating of muscle-stiffness/spasticity and global effects indicated positive effects of botulinum toxin A. Further studies with specific post-injection rehabilitation and longer study period are warranted .

###22019891
OBJECTIVE	Polycystic ovary syndrome ( PCOS ) is a frequent reproductive and metabolic disorder associated with insulin resistance ( IR ) .
OBJECTIVE	Berberine ( BBR ) is an isoquinoline derivative alkaloid extracted from Chinese medicinal herbs that has been used as an insulin sensitizer .
OBJECTIVE	BBR may have a potential therapeutic value for PCOS .
OBJECTIVE	The aim of this study was to evaluate the effects of BBR in comparison to metformin ( MET ) on the metabolic features of women with PCOS .
METHODS	Eighty-nine subjects with PCOS and IR subjects were randomized into one of three treatment groups : BBR + compound cyproterone acetate ( CPA ; n = 31 ) , MET+CPA ( n = 30 ) , and placebo + CPA ( n = 28 ) for 3 months .
METHODS	Clinical characteristics of the women and metabolic and hormonal parameters were assessed before and after the period of treatment .
RESULTS	Treatment with BBR in comparison to MET showed decrease in waist circumference and waist-to-hip ratio ( WHR ; P < 0.01 ) , total cholesterol ( TC ) , triglycerides ( TG ) , and low-density lipoprotein cholesterol ( LDLC ; P < 0.05 ) as well as increase in high-density lipoprotein cholesterol ( HDLC ) and sex hormone-binding globulin ( SHBG ; P < 0.05 ) .
RESULTS	Similarly , treatment with BBR in comparison to placebo showed decrease in WHR , fasting plasma glucose , fasting insulin , homeostasis model assessment for IR , area under the curve of insulin , TC , LDLC , and TG ( P < 0.05 ) as well as increase in HDLC and SHBG ( P < 0.01 ) .
CONCLUSIONS	Intake of BBR improved some of the metabolic and hormonal derangements in a group of treated Chinese women with PCOS .
CONCLUSIONS	Main effects could be related to the changes in body composition in obesity and dyslipidemia .
CONCLUSIONS	Further controlled studies are needed for the assessment of the potential favorable metabolic effects of BBR in women with PCOS .

###18364361
OBJECTIVE	The aim of this paper was to compare the quantity and frequency of alcohol use and its associated negative consequences between two groups of college students who were identified as being `` risky drinkers . ''
OBJECTIVE	Subjects were randomly allocated in a clinical trial to intervention or control groups .
METHODS	Risky drinking use was defined as Alcohol Use Disorders Identification Test ( AUDIT ) > or = 8 and/or Rutgers Alcohol Problem Index ( RAPI ) > or = 5 problems in the previous year .
METHODS	Students who had undergone the Brief Alcohol Screening and Intervention for College Students ( BASICS ) ( N = 145 at baseline ; 142 at 12 months , and 103 at 24 months , loss of 29.7 % ) were compared with a control group ( N = 121 at baseline ; 121 at 12 months and 113 at 24 months , loss of 9.3 % ) , the nonintervention group .
METHODS	Variables included drinking frequency , quantity and peak consumption , dependence assessment , and family and friends ' abuse assessment .
RESULTS	Treated students at a 24-month follow-up decreased quantity of alcohol use per occasion and lowered AUDIT and RAPI scores .
CONCLUSIONS	This is the first brief intervention work on risky drinking with college students in Brazil and the results are encouraging .
CONCLUSIONS	However , it is difficult to conduct individual prevention strategies in a country where culture fosters heavy drinking through poor public policy on alcohol and lack of law enforcement .

###19327616
BACKGROUND	Many patients encounter problems in the first weeks after discharge from hospital .
BACKGROUND	Telephone follow-up ( TFU ) is reputed to be a good tool for providing medical advice , managing symptoms , identifying complications and giving reassurance after discharge .
BACKGROUND	Therefore , we aimed to study whether tight TFU would increase patient satisfaction , improve compliance and reduce re-hospitalization rate .
METHODS	The study population included 400 patients , hospitalized in an Internal Medicine Department , randomly divided into two groups ; TFU and control .
METHODS	TFU took place one week and one month after discharge .
METHODS	Three months later , members of both groups were contacted by telephone .
RESULTS	Satisfaction was increased in the TFU group compared with control group by 6-12 % in most fields .
RESULTS	Notably , 87 % of patients in the TFU group indicated that earlier telephone contact increased their satisfaction .
RESULTS	In addition , 78.2 % of the patients in the control group reported that they performed the tests that were recommended at discharge and 86.5 % reported that they received explanations regarding their medications .
RESULTS	In the TFU group , this percentage was increased significantly to 86.9 % ( P = 0.02 ) and 96.7 % ( P < 0.0001 ) , respectively .
RESULTS	As to treatment results , 93 % of the patients in the TFU group as compared to 84 % in the control group reported improvement in their symptoms .
RESULTS	A non-significant trend towards fewer readmission was observed in the TFU group ( 26 % vs. 35 % P = 0.062 ) .
CONCLUSIONS	TFU can improve medical treatment by increasing satisfaction and compliance .
CONCLUSIONS	A trend towards decreased readmission rates was observed , which may lead to a reduction in the burden on the medical system .

###10330635
OBJECTIVE	To determine whether lidocaine 2 % jelly is an effective topical anesthetic agent for cataract surgery .
METHODS	Private practice and surgicenter .
METHODS	One hundred eighty cataract surgery patients were randomly assigned to 1 of 4 groups of 45 patients each : Group 1-topical eyedrop anesthesia ; Group 2-intracameral lidocaine ; Group 3-lidocaine 2 % jelly applied once , on arrival at the surgicenter ; and Group 4-lidocaine 2 % jelly applied on arrival and about 5 minutes prior to surgery .
METHODS	Each patient was asked about pain or pressure sensation during the operation and afterward .
RESULTS	Single instillation of lidocaine 2 % jelly was associated with pain scores comparable to those with topical eyedrop anesthesia .
RESULTS	When the jelly was readministered shortly before surgery , the pain scores were comparable to those with intracameral anesthesia .
CONCLUSIONS	Lidocaine 2 % jelly was an effective agent in cataract surgery .

###21208398
BACKGROUND	Gastro-intestinal parasitism has been identified as a significant cause of disease in working equids in many countries .
BACKGROUND	This randomized triple-blind trial was designed to assess the impact of an anthelmintic treatment programme ( using oral ivermectin and fenbendazole ) comparing treated and placebo control populations of working donkeys , mules and horses in field conditions in Morocco .
BACKGROUND	In particular , we assessed animal body weight and condition score , together with a questionnaire-based owner evaluation of number of subjective animal health parameters .
BACKGROUND	Faecal worm egg count was also measured .
RESULTS	239 animals completed the full study , 130 in the treatment group and 109 in the control group .
RESULTS	Although the average animal weight increased during the study , this change was not significantly different between the two groups .
RESULTS	Animals in the treatment group had a significantly lower strongyle worm egg count and increased in body condition score compared to animals in the control group at each examination during the study period .
RESULTS	Owners of animals in the treatment group reported improvement in health and work ability and a beneficial effect on pruritus during the early period of the study .
RESULTS	These differences in owner perception between treatment groups had disappeared in the latter stages of the study .
CONCLUSIONS	This study demonstrated that a routine anthelmintic treatment programme of three treatments annually can have a significant effect on faecal worm egg count .
CONCLUSIONS	There may be beneficial consequences for the animal health and productivity .
CONCLUSIONS	Further research on other populations of working equids in different environments would facilitate the objective planning of effective parasite control strategies for specific situations and provide better understanding of the likely clinical benefits of such programmes .

###11192477
BACKGROUND	For many racemic drugs , bioequivalence assessment based on isomer-nonspecific assays is appropriate because enantiomeric area under the concentration-time curve ( AUC ) exposure ratios are close to unity .
BACKGROUND	Use of nonspecific methods in cases in which the ratio is substantially greater or less than 1 , however , may obscure real therapeutic differences among formulations , especially if the enantiomers exhibit differing pharmacological potencies .
OBJECTIVE	To examine the influence of absorption rate on etodolac bioequivalence as measured by total [ ( R , S ) - ] and ( S ) - etodolac .
METHODS	Single dose , 3-period , crossover , pharmacokinetic study in 24 healthy volunteers in which the administration rate of etodolac was varied .
METHODS	Participants received etodolac 400mg in solution , given as a single dose over 1 minute or as divided doses over 30 and 90 minutes .
METHODS	Unresolved and enantiomer concentrations of etodolac were measured by a validated HPLC assay .
METHODS	The enantiomer ratio was similarly measured by HPLC .
RESULTS	Bioequivalence parameters derived for both unresolved and ( S ) etodolac indicate that peak plasma drug concentration ( Cmax ) was not bioequivalent .
RESULTS	By delaying absorption , bioequivalence was lost .
CONCLUSIONS	Collectively , these data demonstrate that bioequivalence between 2 products of etodolac based on enantiomerically nonspecific criteria alone may not generalise to the pharmacologically relevant ( S ) - enantiomer .
CONCLUSIONS	This suggests that enantiospecific assays are necessary for bioequivalence assessments .

###20799973
BACKGROUND	Osteoporosis-related fractures are a significant public health concern .
BACKGROUND	Interventions that increase detection and treatment of osteoporosis are underutilized .
BACKGROUND	This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures .
METHODS	This was a 12-month randomized trial performed in Ontario , Canada .
METHODS	Eligible patients were community-dwelling , aged 55 years , and identified to be at risk for osteoporosis-related fractures .
METHODS	Two hundred and one patients were allocated to the intervention group or to usual care .
METHODS	Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing , patient education and patient-specific recommendations for osteoporosis treatment .
METHODS	The primary outcome was the implementation of appropriate osteoporosis management .
RESULTS	101 patients were allocated to intervention and 100 to control .
RESULTS	Mean age of participants was 71.9 7.2 years and 94 % were women .
RESULTS	Pharmacological treatment ( alendronate , risedronate , or raloxifene ) for osteoporosis was increased by 29 % compared to usual care ( 56 % [ 29/52 ] vs. 27 % [ 16/60 ] ; relative risk [ RR ] 2.09 , 95 % confidence interval [ CI ] 1.29 to 3.40 ) .
RESULTS	More individuals in the intervention group were taking calcium ( 54 % [ 54/101 ] vs. 20 % [ 20/100 ] ; RR 2.67 , 95 % CI 1.74 to 4.12 ) and vitamin D ( 33 % [ 33/101 ] vs. 20 % [ 20/100 ] ; RR 1.63 , 95 % CI 1.01 to 2.65 ) .
CONCLUSIONS	A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care .
BACKGROUND	This trial has been registered with clinicaltrials.gov ( ID : NCT00465387 ) .

###25075834
BACKGROUND	Artemisinin resistance in Plasmodium falciparum has emerged in Southeast Asia and now poses a threat to the control and elimination of malaria .
BACKGROUND	Mapping the geographic extent of resistance is essential for planning containment and elimination strategies .
METHODS	Between May 2011 and April 2013 , we enrolled 1241 adults and children with acute , uncomplicated falciparum malaria in an open-label trial at 15 sites in 10 countries ( 7 in Asia and 3 in Africa ) .
METHODS	Patients received artesunate , administered orally at a daily dose of either 2 mg per kilogram of body weight per day or 4 mg per kilogram , for 3 days , followed by a standard 3-day course of artemisinin-based combination therapy .
METHODS	Parasite counts in peripheral-blood samples were measured every 6 hours , and the parasite clearance half-lives were determined .
RESULTS	The median parasite clearance half-lives ranged from 1.9 hours in the Democratic Republic of Congo to 7.0 hours at the Thailand-Cambodia border .
RESULTS	Slowly clearing infections ( parasite clearance half-life > 5 hours ) , strongly associated with single point mutations in the `` propeller '' region of the P. falciparum kelch protein gene on chromosome 13 ( kelch13 ) , were detected throughout mainland Southeast Asia from southern Vietnam to central Myanmar .
RESULTS	The incidence of pretreatment and post-treatment gametocytemia was higher among patients with slow parasite clearance , suggesting greater potential for transmission .
RESULTS	In western Cambodia , where artemisinin-based combination therapies are failing , the 6-day course of antimalarial therapy was associated with a cure rate of 97.7 % ( 95 % confidence interval , 90.9 to 99.4 ) at 42 days .
CONCLUSIONS	Artemisinin resistance to P. falciparum , which is now prevalent across mainland Southeast Asia , is associated with mutations in kelch13 .
CONCLUSIONS	Prolonged courses of artemisinin-based combination therapies are currently efficacious in areas where standard 3-day treatments are failing .
CONCLUSIONS	( Funded by the U.K. Department of International Development and others ; ClinicalTrials.gov number , NCT01350856 . )

###25514079
OBJECTIVE	This study aimed to compare the clinical and radiographic success of preveneered posterior NuSmile and Kinder Krowns over one year and to assess the level of parental satisfaction with their esthetics .
METHODS	Three trained operators placed 120 crowns in a split-mouth design with a random allocation for 36 participants ( mean age : 5.8 years ) who received two , four , six , or eight crowns .
METHODS	Blind assessment of the clinical and radiographic performance of the restorations was performed by four calibrated examiners after one year .
METHODS	Results were analyzed by Fisher 's exact test and McNemar test .
METHODS	Examiner reliability was determined by Cohen 's kappa score .
METHODS	Visual analogue scale ( VAS ) was used to assess the level of parental satisfaction .
RESULTS	All crowns but one were retained , and the majority ( 83 percent ) had no facing fractures .
RESULTS	Parental satisfaction was high ( 9.4 / 10 on the VAS ) .
RESULTS	Primary maxillary first molar crowns had more occlusal facing fractures than their mandibular counterparts ( P = .02 ) .
RESULTS	Primary mandibular second molar crowns showed more facing fractures than their maxillary counterparts ( P = .008 ) .
RESULTS	Both types showed no statistical difference in most categories , but Kinder Krowns had more facing fractures ( P < .02 ) .
CONCLUSIONS	Posterior preveneered crowns have predictable durability at 12 months while offering natural appearance to restored teeth .

###23590978
OBJECTIVE	Additional treatments with persisting benefit are needed for ADHD .
OBJECTIVE	Because ADHD often shows excessive theta electroencephalogram ( EEG ) power , low beta , and excessive theta-beta ratio ( TBR ) , a promising treatment is neurofeedback ( NF ) downtraining TBR .
OBJECTIVE	Although several nonblind randomized clinical trials ( RCTs ) show a medium-large benefit for NF , a well-blinded , sham-controlled RCT is needed to differentiate specific from nonspecific effects .
METHODS	Experts in NF , ADHD , clinical trials , and statistics collaborated to design a double-blind multisite RCT .
CONCLUSIONS	At four sites , 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR 5 will be randomized to active TBR-NF versus sham NF of equal duration , intensity , and appearance .
CONCLUSIONS	Sham , utilizing prerecorded EEGs with participant artifacts superimposed , will keep participants and staff blind .
CONCLUSIONS	Treatment fidelity will be trained/monitored by acknowledged NF leaders .
CONCLUSIONS	Multidomain assessments before , during , and after treatment ( follow-up to 2 years ) will also include tests of blinding and sham inertness .

###16326677
OBJECTIVE	To establish the effect of increasing concentrations of remifentanil on sevoflurane requirements in children .
METHODS	Fifty-eight healthy patients , ASA status I-II aged two to 12 yr , undergoing abdominal wall hernia or hydrocele repairs were serially assigned to one of four test groups to receive remifentanil 0.03 microg.kg ( -1 ) .
METHODS	min ( -1 ) , 0.06 microg.kg ( -1 ) .
METHODS	min ( -1 ) , 0.12 microg.kg ( -1 ) .
METHODS	min ( -1 ) , or 0.25 microg.kg ( -1 ) .
METHODS	min ( -1 ) iv .
METHODS	Patients received a bolus of remifentanil 1 microg.kg ( -1 ) iv before the infusion began .
METHODS	End-tidal sevoflurane concentration was adjusted according to a Dixon up-and-down approach .
METHODS	Ten minutes after starting the remifentanil infusion , the surgical incision was made .
METHODS	The patient was observed for one minute from the time of incision by a solitary blinded rater for either flexion or withdrawal of one or more extremities in response to skin incision .
RESULTS	The mean minimum alveolar concentration of sevoflurane was 2.39 + / - 0.58 with 0.03 microg.kg ( -1 ) .
RESULTS	min ( -1 ) remifentanil , 1.91 + / - 0.36 with 0.06 microg.kg ( -1 ) .
RESULTS	min ( -1 ) remifentanil , and 0.92 + / - 0.11 with 0.12 microg.kg ( -1 ) .
RESULTS	min ( -1 ) remifentanil .
RESULTS	Remifentanil 0.25 microg.kg ( -1 ) .
RESULTS	min ( -1 ) lead to the sevoflurane being decreased to a level associated with spontaneous patient awakening .
RESULTS	The effective dose ( ED ( 50 ) ) values of sevoflurane were 2.44 [ 95 % confidence interval ( CI ) 2.16-2 .72 ] , 2.00 ( 95 % CI 1.78-2 .22 ) , and 1.18 ( 95 % CI 0.99-1 .36 ) for remifentanil infusion rates of 0.03 microg.kg ( -1 ) .
RESULTS	min ( -1 ) , 0.06 microg.kg ( -1 ) .
RESULTS	min ( -1 ) , and 0.12 microg.kg ( -1 ) .
RESULTS	min ( -1 ) respectively .
CONCLUSIONS	The administration of remifentanil produced a dose-dependent decrease in the minimum alveolar concentration of sevoflurane necessary for inhibition of movement reaction in response to surgical incision .
CONCLUSIONS	The use of remifentanil may allow for flexible analgesic control and rapid recovery in children anesthetized with sevoflurane .

###23794338
OBJECTIVE	In regarding to azithromycin 's high tissue concentration , long biologic half life , low cost , and excellent anti bacterial profile for Helicobacter pylori in Iran , we sought to compare an azithromycin-based regimen with an already established clarithromycinbased regimen in regards to the eradication of Helicobacter pylori infection .
METHODS	A prospective , open label , randomized controlled trial was conducted on 165 patients who presented to gastrointestinal clinics of QOM Medical University Clinics , with complaint of dyspepsia .
METHODS	All patients received upper gastrointestinal endoscopy , and underwent rapid urease test to confirm Helicobacter pylori infection .
METHODS	Patients were randomized to a treatment arm , which consisted of , clarithromycin , amoxicillin , and omeprazole , or another treatment arm consisting of azithromycin , amoxicillin , and omeprazole .
METHODS	Informed consent was obtained from all patients participating in the trial .
METHODS	Urease breath test was performed in patients 6 weeks after end of treatment to assess eradication .
METHODS	All side effects were recorded .
METHODS	Comparison between the two groups was made using a chi-square test .
RESULTS	Seventy six and 89 patients received regimen clarithromycin , amoxicillin , and omeprazole and azithromycin , amoxicillin , and omeprazole , respectively , and completed the study course .
RESULTS	Per protocol , eradication rate was 83 % with clarithromycin , amoxicillin , and omeprazole and 75 % with azithromycin , amoxicillin , and omeprazole ( p = 0.158 ) .
RESULTS	Eradication rate for a subgroup of patients with peptic ulcer disease in two groups were 83 % and 74 % , respectively ( p = 0.134 ) .
RESULTS	Only one patient in each group was compelled to stop the treatment due to a severe skin hypersensitivity reaction .
RESULTS	Other lesser side effects were comparable within the two groups .
CONCLUSIONS	The results of this study suggest that azithromycin , amoxicillin , and omeprazole at best is as effective as clarithromycin , amoxicillin , and omeprazole ; and this new therapy could be considered as an alternative choice for Helicobacter pylori eradication , especially in geographic areas with lower economic status .

###22369708
OBJECTIVE	We evaluated the impact of educational interventions on sugary snacking in infants and toddlers in Tehran , Iran .
METHODS	A 6-month intervention was integrated into health staff duties .
METHODS	We assigned 12 - to 15-month-olds ( n = 242 ) and their mothers attending the vaccination offices of 18 randomly selected public health centers into the following groups : pamphlet and reminder ( A ) , pamphlet only ( B ) , and one control group ( C ) .
METHODS	The mothers were interviewed at baseline and after follow-up .
METHODS	We recorded the frequency of sugary snacking for both the children and their mothers and calculated changes over 6 months .
METHODS	A reduction in the children 's snacking frequency indicated a positive outcome .
METHODS	The family 's residential area ( affluent/nonaffluent ) indicated its socioeconomic level .
METHODS	Associations between the children 's and their mothers ' snacking frequency were assessed by means of Spearman correlation .
METHODS	The outcomes of each intervention group were compared separately to those of the control group by means of the Mann-Whitney test .
METHODS	In addition , we performed intention to treat analysis .
METHODS	Factors related to a positive outcome were explained by means of logistic regression models .
RESULTS	In all groups , the child 's and mother 's snacking at baseline correlated ( r = 0.4 ) .
RESULTS	A positive outcome was found for 62 % of the children in group A and for 49 % and 32 % in groups B and C , respectively .
RESULTS	In group A , a reduction in the children 's snacking frequency was found despite their residential area ( P < 0.05 ) .
RESULTS	Controlling for intervention effects , the logistic regression model showed that residential area was unrelated to the positive outcome .
CONCLUSIONS	Oral health education with reminders provided to mothers by general health staff is a valuable tool for reducing sugary snacking in infants and toddlers in a country with developing oral health systems .

###18372218
BACKGROUND	The aim of this study was to evaluate the effects of high frequency exercise for patients before and after an elective percutaneous coronary intervention ( PCI ) , with special reference to maximal aerobic capacity , muscle function , health related quality of life ( HRQoL ) , waist-hip ratio ( WHR ) and restenosis .
METHODS	A randomised , controlled study was performed in Sweden between 2004 and 2006 in thirty-seven patients ( five women ) with stable coronary artery disease ( CAD ) , age 63.6 + / -6.9 years , randomised to either high frequency exercise or control group .
METHODS	The patients in the training group performed three endurance resistance exercises and trained on a cycle ergometer 30 min , 5 times a week for 8 months at 70 % of VO ( 2max ) .
RESULTS	Patients in the training group significantly improved their maximal aerobic capacity ( 15 ( 9-46 ) vs. 8 ( 0-18 ) % p < or = 0.05 ) , shoulder flexion ( p < or = 0.01 ) , shoulder abduction ( p < or = 0.01 ) and heel-lift ( p < or = 0.05 ) compared to the control group .
RESULTS	There were no significant differences between the groups in HRQoL , WHR and restenosis .
CONCLUSIONS	High frequency exercise in patients treated with PCI seems to improve maximal aerobic capacity and muscle function , which may reduce the risks of further progression of atherosclerosis .
CONCLUSIONS	However , further larger studies are needed to fully investigate the effects of exercise in patients with PCI .

###17519820
BACKGROUND	There is no standard second-line treatment for small cell lung cancer ( SCLC ) .
BACKGROUND	The prognosis of these patients is poor and special attention should be paid to both quality of life and economic factors .
METHODS	The aim of this phase II randomised trial ( GFPC0501 ) is to compare , in patients with progressive SCLC after first-line platinum based chemotherapy , oral multi drug chemotherapy ( CCNU , cyclophosphamide , etoposide ) and classical intravenous chemotherapy with cyclophosphamide , doxorubicin and vincristine ( CAV ) in terms of tolerability , efficacy ( response rate , median one year survival and overall survival ) , quality of life and consumption of health care resources .
METHODS	Based on a two-stage Bryant and Day approach , this study will require a total of 138 patients with an interim analysis of the first 38 .
RESULTS	This trial will provide information on several aspects of second-line chemotherapy for patients with SCLC .
RESULTS	Thirty six patients have been enrolled in 16 centres by December 2006 and the results of the interim analysis will be available in June 2007 .

###20530316
BACKGROUND	Oropharyngeal squamous-cell carcinomas caused by human papillomavirus ( HPV ) are associated with favorable survival , but the independent prognostic significance of tumor HPV status remains unknown .
METHODS	We performed a retrospective analysis of the association between tumor HPV status and survival among patients with stage III or IV oropharyngeal squamous-cell carcinoma who were enrolled in a randomized trial comparing accelerated-fractionation radiotherapy ( with acceleration by means of concomitant boost radiotherapy ) with standard-fractionation radiotherapy , each combined with cisplatin therapy , in patients with squamous-cell carcinoma of the head and neck .
METHODS	Proportional-hazards models were used to compare the risk of death among patients with HPV-positive cancer and those with HPV-negative cancer .
RESULTS	The median follow-up period was 4.8 years .
RESULTS	The 3-year rate of overall survival was similar in the group receiving accelerated-fractionation radiotherapy and the group receiving standard-fractionation radiotherapy ( 70.3 % vs. 64.3 % ; P = 0.18 ; hazard ratio for death with accelerated-fractionation radiotherapy , 0.90 ; 95 % confidence interval [ CI ] , 0.72 to 1.13 ) , as were the rates of high-grade acute and late toxic events .
RESULTS	A total of 63.8 % of patients with oropharyngeal cancer ( 206 of 323 ) had HPV-positive tumors ; these patients had better 3-year rates of overall survival ( 82.4 % , vs. 57.1 % among patients with HPV-negative tumors ; P < 0.001 by the log-rank test ) and , after adjustment for age , race , tumor and nodal stage , tobacco exposure , and treatment assignment , had a 58 % reduction in the risk of death ( hazard ratio , 0.42 ; 95 % CI , 0.27 to 0.66 ) .
RESULTS	The risk of death significantly increased with each additional pack-year of tobacco smoking .
RESULTS	Using recursive-partitioning analysis , we classified our patients as having a low , intermediate , or high risk of death on the basis of four factors : HPV status , pack-years of tobacco smoking , tumor stage , and nodal stage .
CONCLUSIONS	Tumor HPV status is a strong and independent prognostic factor for survival among patients with oropharyngeal cancer .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00047008 . )

###15066470
OBJECTIVE	To evaluate serial hormone concentrations in subjects treated with vaginally administered misoprostol for early pregnancy failure .
METHODS	As part of a randomized clinical trial , serum was collected on treatment days 1 , 3 , 8 , and 15 .
METHODS	Multicenter clinical trial .
METHODS	Women with a nonviable first-trimester pregnancy .
METHODS	Serum concentrations of human chorionic gonadotropin ( hCG ) , progesterone , and sex hormone binding globulin ( SHBG ) were evaluated .
METHODS	A logistic regression model was constructed to assess the associations of percent and complete expulsion of the gestational sac and/or successful management .
RESULTS	The percent change from the day of treatment until the first follow-up visit was predictive for complete expulsion for progesterone ( P ) ( P < .005 ) and hCG ( P < .005 ) , but not for SHBG .
RESULTS	The actual value was not significantly associated with complete expulsion or successful management .
RESULTS	A decrease ( day 1-3 ) of 79 % for both hCG and P was associated with a 90 % probability of complete passage of the gestational sac .
RESULTS	A 90 % probability of successful management was noted if P decreased by 78 % on day 3 or 59 % on day 7 , or hCG decreased by 74 % on day 3 or 78 % on day 7 compared with pretreatment values .
CONCLUSIONS	Percent change , but not absolute change , in serial hormone values are strongly associated with both the complete expulsion of the gestational sac with one dose of misoprostol and ultimate success .

###24174392
OBJECTIVE	To assess whether weight loss improves markers of peripheral artery disease and vascular stenosis .
METHODS	The Action for Health in Diabetes randomized clinical trial compared intensive lifestyle intervention ( ILI ) for weight loss to a control condition of diabetes support and education ( DSE ) in overweight or obese adults with type 2 diabetes .
METHODS	Annual ankle and brachial blood pressures over four years were used to compute ankle-brachial indices ( ABIs ) and to assess interartery blood pressure differences in 5018 participants .
RESULTS	ILI , compared to DSE , produced 7.8 % ( Year 1 ) to 3.6 % ( Year 4 ) greater weight losses .
RESULTS	These did not affect prevalence of low ( < 0.90 ) ABI ( 3.60 % in DSE versus 3.14 % in ILI ; P = 0.20 ) or elevated ( > 1.40 ) ABI ( 7.52 % in DSE versus 7.59 % in ILI : P = 0.90 ) , but produced smaller mean ( SE ) maximum interartery systolic blood pressure differences among ankle sites [ 19.7 ( 0.2 ) mmHg for ILI versus 20.6 ( 0.2 ) mmHg for DSE ( P < 0.001 ) ] and between arms [ 5.8 ( 0.1 ) mmHg for ILI versus 6.1 ( 0.1 ) mmHg for DSE ( P = 0.01 ) ] .
CONCLUSIONS	Four years of intensive behavioral weight loss intervention did not significantly alter prevalence of abnormal ABI , however , it did reduce differences in systolic blood pressures among arterial sites .

###18161760
BACKGROUND	It is questionable whether elective appendicectomy can effectively reduce persistent or recurrent right lower-quadrant abdominal pain due to chronic or recurrent appendicitis .
METHODS	This single-centre double-blind randomized clinical trial studied the effects of elective laparoscopic appendicectomy on pain 6 months after operation in patients with persistent or recurrent lower-quadrant pain .
METHODS	A secondary outcome evaluated was the relationship between clinical response and appendiceal histopathology .
METHODS	The analysis was performed on an intention-to-treat basis .
RESULTS	Forty patients were randomized to laparoscopic appendicectomy ( 18 ) or laparoscopic inspection only ( 22 ) .
RESULTS	Postoperative pain scores differed significantly between the groups , favouring appendicectomy ( P = 0.005 ) .
RESULTS	Relative risk calculations indicated that there was a 2.4 ( 95 per cent confidence interval ( c.i. ) 1.3 to 4.0 ) times greater chance of improvement in pain after laparoscopic appendicectomy .
RESULTS	The number needed to treat was 2.2 ( 95 per cent c.i. 1.5 to 6.5 ) .
RESULTS	There was no association between postoperative pain scores and histopathology findings .
CONCLUSIONS	Persistent or recurrent lower abdominal pain can be treated by elective appendicectomy with significant pain reduction in properly selected cases .
CONCLUSIONS	Histopathology may not be abnormal .
BACKGROUND	ISRCTN48831122 ( http://www.controlled-trials.com ) .

###25938633
BACKGROUND	HIV infection is associated with a greater risk for fasting hyperinsulinemia , impaired glucose tolerance , and higher incidence rates for vascular disease , myocardial infarction , or stroke despite effective combination antiretroviral therapy ( cART ) .
BACKGROUND	The underlying mechanism ( s ) may involve chronic low-grade systemic inflammation and immune cell activation .
BACKGROUND	Dipeptidyl peptidase-4 inhibitors ( sitagliptin ) improve glucose tolerance and may possess immunomodulatory effects because leukocyte CD26 cell surface receptors express dipeptidyl peptidase-4 activity .
OBJECTIVE	Sitagliptin will reduce inflammatory and immune cell activation markers known to be elevated in cART-treated HIV-infected ( HIV + ) adults with impaired glucose tolerance .
METHODS	This was designed as a prospective , randomized , placebo-controlled , double-blind trial of sitagliptin in HIV + adults .
METHODS	The setting was an academic medical center .
METHODS	Patients were cART-treated HIV + men and women ( n = 36 ) with stable HIV disease and impaired glucose tolerance .
METHODS	Interventions included sitagliptin 100 mg/d or placebo for 8 weeks .
METHODS	At baseline and week 8 , plasma high-sensitivity C-reactive protein and C-X-C motif chemokine 10 concentrations ( ELISA ) , oral glucose tolerance , and abdominal sc adipose mRNA expression for M1 macrophage markers ( monocyte chemotactic protein-1 , EGF-like module-containing , mucin-like hormone receptor 1 ) .
RESULTS	Sitagliptin reduced glucose area under the curve ( P = .002 ) and improved oral glucose insulin sensitivity index ( P = .04 ) more than placebo .
RESULTS	Sitagliptin reduced plasma high-sensitivity C-reactive protein and C-X-C motif chemokine 10 levels more than placebo ( P < .009 ) .
RESULTS	Adipose tissue monocyte chemotactic protein-1 mRNA abundance declined significantly more ( P = .01 ) , and adipose EGF-like module-containing , mucin-like hormone receptor 1 mRNA expression tended to decline more ( P = .19 ) in sitagliptin than placebo .
CONCLUSIONS	Sitagliptin had beneficial systemic and adipose anti-inflammatory effects in cART-treated HIV + adults with impaired glucose tolerance .
CONCLUSIONS	Large-scale , long-term studies should determine whether sitagliptin reduces cardiovascular risk and events in HIV + adults .

###19575048
OBJECTIVE	To evaluate gingival recession changes after six months of brushing with an oscillating-rotating power toothbrush ( PT ) or an ADA reference manual toothbrush ( MT ) .
METHODS	Healthy subjects with pre-existing recession were assigned to brush with either a PT ( n = 55 ) or an ADA reference MT ( n = 54 ) according to a prospective randomized , controlled , single-blind , parallel group design .
METHODS	Participants were asked to brush their teeth twice daily for two minutes each with the same fluoride toothpaste .
METHODS	Clinical attachment loss and probing pocket depths ( PPDs ) were measured at six sites per tooth to the nearest mm by one calibrated examiner at baseline and after six months .
METHODS	Gingival recession was calculated as the differences between clinical attachment loss and PPDs overall and separately at individual sites .
RESULTS	As compared with baseline , overall recession at six months was reduced from 2.35 + / - 0.35 mm to 1.98 + / - 0.55 mm ( p < 0.001 ) in the PT group and from 2.26 + / - 0.31 mm to 1.90 + / - 0.45 mm ( p < 0.001 ) in the MT group .
RESULTS	The data showed 40 % ( power ) and 38 % ( manual ) of all recession sites improved by at least 0.5 mm while 51 % and 54 % remained unchanged .
RESULTS	Eight percent and 7 % recessions increased over time .
RESULTS	Differences between groups were not statistically significant at either timepoint .
CONCLUSIONS	Both the PT and the MT significantly reduced pre-existing gingival recession after six months of brushing .
CONCLUSIONS	This may have been due to improved brushing technique ( i.e. , Hawthorne effect ) .
CONCLUSIONS	Based on these six-month data , concern that power tooth brushing results in a higher risk for gingival recession is not warranted .

###12955409
BACKGROUND	Fractional flow reserve ( FFR ) is a measure of coronary stenosis severity that is based on pressure measurements obtained at maximal hyperemia .
BACKGROUND	Therefore , achievement of maximal vasodilatation of the coronary microcirculation is a prerequisite for the measurement of FFR .
BACKGROUND	The study was designed to address the hypothesis that intracoronary adenosine yields more complete vasodilatation of the coronary microcirculation when high doses are used , resulting in a more accurate FFR measurement .
METHODS	Thirty-six patients with 43 moderate lesions underwent determination of FFR during cardiac catheterization .
METHODS	FFR was calculated in all lesions as the ratio of the distal coronary pressure to the aortic pressure at hyperemia .
METHODS	Different incremental doses of intracoronary adenosine ( 16 , 24 , 32 and 40 microg for both coronary arteries ) were administered in a randomized fashion .
RESULTS	No adverse events occurred with any intracoronary adenosine bolus .
RESULTS	At baseline there were no significant differences for mean aortic and distal coronary pressure , heart rate as well as FFR values between the different doses .
RESULTS	FFR was not significantly altered from the different incremental adenosine doses .
RESULTS	However , in 27 ( 63 % ) out of 43 lesions there was a further reduction of FFR up to 0.23 when a dose > 16 microg was injected .
CONCLUSIONS	This study suggests that doses of adenosine up to 40 microg are safe and can be used to achieve a more pronounced vasodilatation in individual patients compared to the standard doses .
CONCLUSIONS	This may have therapeutic impact with FFR values near cut-off points in patients undergoing diagnostic coronary angiography as well as in patients in whom FFR is used to assess the outcome of interventions .

###23161001
BACKGROUND	In laboratory animals , the biological stressor yohimbine ( ( 2 ) - noradrenergic autoreceptor antagonist ) promotes drug seeking .
BACKGROUND	Human laboratory studies have demonstrated that psychological stressors can increase drug craving but not that stressors alter drug seeking .
OBJECTIVE	This clinical study tested whether yohimbine increases opioid-seeking behavior .
METHODS	Ten heroin-dependent , buprenorphine-stabilized ( 8 mg/day ) volunteers sampled two doses of hydromorphone [ 12 and 24 mg IM in counterbalanced order , labeled drug A ( session 1 ) and drug B ( session 2 ) ] .
METHODS	During each of six later sessions ( within-subject , double-blind , randomized crossover design ) , volunteers could respond on a 12-trial choice progressive ratio task to earn units ( 1 or 2 mg ) of the sampled hydromorphone dose ( drug A or B ) vs money ( $ 2 ) following different oral yohimbine pretreatment doses ( 0 , 16.2 , and 32.4 mg ) .
RESULTS	Behavioral economic demand intensity and peak responding ( O ( max ) ) were significantly higher for hydromorphone 2 than 1 mg .
RESULTS	Relative to placebo , yohimbine significantly increased hydromorphone demand inelasticity , more so for hydromorphone 1-mg units ( P ( max ) = 909 , 3,647 , and 3,225 for placebo , 16.2 , and 32.4 mg yohimbine doses , respectively ) than hydromorphone 2-mg units ( P ( max ) = 2,656 , 3,193 , and 3,615 , respectively ) .
RESULTS	Yohimbine produced significant but clinically modest dose-dependent increases in blood pressure ( systolic15 and diastolic10 mmHg ) and opioid withdrawal symptoms , and decreased opioid agonist symptoms and elated mood .
CONCLUSIONS	These findings concur with preclinical data by demonstrating that yohimbine increases drug seeking ; in this study , these effects occurred without clinically significant subjective distress or elevated craving , and partly depended on opioid unit dose .

###25818925
OBJECTIVE	To characterize anatomic and visual outcomes in patients with full-thickness macular hole ( FTMH ) at baseline in ocriplasmin phase 3 clinical trials , focusing on the relationship between resolution of vitreomacular adhesion and FTMH closure .
METHODS	Two multicenter , randomized , double-masked clinical trials .
METHODS	Pharmacologic FTMH closure was one of multiple secondary endpoints .
METHODS	OCT scans were obtained at baseline and at all postinjection visits , and for patients with baseline FTMH , evaluated for FTMH width , vitreomacular adhesion , and epiretinal membrane .
RESULTS	FTMH closure was observed in a greater proportion of ocriplasmin - vs vehicle-injected patients with baseline FTMH width 250 m ( 58.3 % vs 16.0 % , P < .001 ) and > 250 to 400 m ( 36.8 % vs 5.3 % , P = .009 ) .
RESULTS	Among FTMH patients in the ocriplasmin group , 2-line visual acuity gains at month 6 were achieved by a greater percentage of those who achieved hole closure at day 28 vs those who did not achieve this outcome ( 72.1 % vs 25.4 % ) .
CONCLUSIONS	Ocriplasmin demonstrated efficacy in closure of small and medium FTMH , and in FTMH without epiretinal membrane at baseline .
CONCLUSIONS	Visual acuity gains occurred more frequently when hole closure was achieved after ocriplasmin treatment compared to when this outcome did not occur .
CONCLUSIONS	Ocriplasmin treatment is an additional option for the management of patients with FTMH and vitreomacular adhesion .

###16222404
BACKGROUND	A number of frail , older , undernourished patients can not maintain adequate oral intake to meet protein-calorie needs after an illness , even when high-density nutritional supplements are added .
BACKGROUND	Tolerance to enteral nutrition by gastric tube is poor in this group of patients .
BACKGROUND	Peripheral parenteral nutrition is an effective method of administering nutritional support to patients with mild to moderate nutritional deficiencies who are unable to receive enteral nutrition or for whom enteral nutrition alone can not meet energy needs .
BACKGROUND	However , no data exists for the use of peripheral parenteral nutrition longer than two weeks and overall there are remarkably few studies on the efficacy of peripheral parenteral nutrition .
METHODS	A Phase 4 , single center , prospective , randomized , parallel group design clinical trial was conducted to evaluate long-term safety of peripheral parenteral nutrition in post-acute patients receiving inadequate enteral nutrition .
METHODS	Nutritional status was measured by the Mini-Nutritional Assessment and functional status by the Functional Inventory Measure .
METHODS	Subjects received a mean duration for peripheral parenteral nutrition of 15.8 + / - 6.7 days ( range 8-23 ) .
RESULTS	The peripheral parenteral nutrition group demonstrated several trends towards improvement in prealbumin , CD4 cell count , and functional status compared to the untreated control group .
RESULTS	Two patients in the peripheral parenteral nutrition group developed low-grade phlebitis ; however , this did not result in discontinuing intravenous therapy .
RESULTS	No other adverse events occurred .
RESULTS	This study demonstrates that peripheral parenteral nutrition is feasible and safe in postacute care .
CONCLUSIONS	We conclude that peripheral parenteral nutrition can be safely administered in post-acute settings with a low rate of complications .

###9011784
BACKGROUND	Injections of allergens are widely prescribed for patients with asthma , but little is known about the effectiveness of immunotherapy .
METHODS	We conducted a double-blind , placebo-controlled trial of multiple-allergen immunotherapy in 121 allergic children with moderate-to-severe , perennial asthma .
METHODS	The children , who required daily medication for their asthma , were randomly assigned to receive subcutaneous injections of either a mixture of up to seven aeroallergen extracts or a placebo .
METHODS	Maintenance injections were continued for 18 months or longer .
METHODS	Medications were adjusted every two to three weeks on the basis of peak flow rates and symptoms .
METHODS	The principal outcome was the daily medication score .
METHODS	Bronchial sensitivity to methacholine ( the concentration provoking a 20 percent decrease in the forced expiratory volume in one second [ PC20 ] ) was measured twice yearly .
RESULTS	The median medication score declined from 5.4 to 4.9 in the immunotherapy group ( P < 0.001 ) and from 5.2 to 5.0 in the placebo group ( P < 0.001 ) , but there was no significant difference between the groups ( P > 0.6 ) .
RESULTS	The number of days on which oral corticosteroids were used was similar in the two groups .
RESULTS	Partial or complete remission of asthma occurred in 31 percent of the immunotherapy group and in 28 percent of the placebo group ( P > 0.5 ) .
RESULTS	There was no difference between the groups in the use of medical care , symptoms , or peak flow rates .
RESULTS	The median PC20 increased significantly in both groups , but again with no difference between the two groups .
CONCLUSIONS	Immunotherapy with injections of allergens for over two years was of no discernible benefit in allergic children with perennial asthma who were receiving appropriate medical treatment .

###22932864
BACKGROUND	The usage of a drain following evacuation of a chronic subdural haematoma ( CSDH ) is known to reduce recurrence .
BACKGROUND	In this study we aim to compare the clinical outcomes and recurrence rate of utilising two different types of drains ( subperiosteal and subdural drain ) following drainage of a CSDH .
METHODS	Prospective randomised single-centre study analysing 50 patients who underwent CSDH treatment .
METHODS	Two types of drains , subperiosteal ( SPD ) and subdural ( SDD ) , were utilised on consecutive alternate patients following burr-hole craniostomy , with a total of 25 patients in each group .
METHODS	The drains were left in for 48-h duration and then removed .
METHODS	The modified Rankin Scale ( mRS ) was used for outcome measurement at 3 and 6months .
RESULTS	Data analysis was performed by unpaired t test with Welch 's correction .
RESULTS	It was observed that none of the patients in either group had haematoma recurrence during a 6-month follow-up , and a significant difference in outcome was noted at 6months ( p = 0.0118 ) more than at 3months ( p = 0.0493 ) according to the statistical analysis .
RESULTS	Postoperative seizure and inadvertent placement of the subdural drain into the brain parenchyma were the two complications noted in this study .
RESULTS	Anticoagulant use prior to the surgery did not affect the outcome in either group .
CONCLUSIONS	We conclude there was no recurrence of CSDH utilising the SDD and SPD following burr-hole craniostomy .
CONCLUSIONS	The mRS measurement at the 6-month follow-up was found to be statistically significant , with better outcomes with utilisation of the SPD .
CONCLUSIONS	The SPD may thus prove to be more beneficial than the SDD in the treatment of CSDH .
CONCLUSIONS	A multi-centre study with a larger group of patients is recommended to reinforce the results from our study .

###21323599
BACKGROUND	Recent literature advocates the decrease of the upper limit of the normal thyrotropin ( TSH ) reference range .
BACKGROUND	The objective of this study was to determine whether treated hypothyroid patients maintained within a low-normal TSH range ( 0.4-2 .0 mIU/L ) have better clinical outcomes than those maintained within a high-normal TSH range ( 2.0-4 .0 mIU/L ) .
METHODS	The study was performed in a thyroid outpatient clinic of a tertiary hospital .
METHODS	This was a prospective , interventional study .
METHODS	Forty-two participants with newly diagnosed overt primary hypothyroidism were paired in two groups : group 1 ( n = 20 ) , low-normal target TSH ; group 2 ( n = 22 ) , high-normal target TSH .
METHODS	Levothyroxine was initiated , and dose was adjusted to achieve and sustain the target TSH value during the study period .
METHODS	After the target TSH was reached , participants were evaluated every 3 months for thyroid function , serum lipid profile , resting energy expenditure ( REE ) , body composition , and bone mineral density , for 12 months .
RESULTS	Nineteen patients in group 1 and 16 in group 2 completed the study .
RESULTS	In the whole-group analysis , total cholesterol ( p = 0.01 ) , low-density lipoprotein cholesterol ( p = 0.004 ) , and triglycerides ( p < 0.001 ) decreased after treatment , whereas REE per kilogram of lean body mass ( p = 0.001 ) and total fat body mass ( p = 0.02 ) increased .
RESULTS	Group 1 patients had a significantly higher relative increase in REE ( +7.1 % 11.3 % vs. +3.6 % 15.1 % , p = 0.02 ) .
RESULTS	There was no difference between the groups in the other variables .
CONCLUSIONS	Despite recent trends toward lowering the upper limit of normal TSH range , the results of this 12-month study provided no substantial clinical evidence to corroborate that treatment of primary hypothyroidism should aim at maintaining TSH levels in a low-normal range

###22449831
OBJECTIVE	To determine whether gall bladder ( GB ) retrieval from umbilical port is associated with more pain at port site as compared to GB retrieval from epigastric port in adult patients undergoing four port elective laparoscopic cholecystectomy at a tertiary care hospital .
METHODS	Adult patients , who were undergoing elective laparoscopic cholecystectomy during a six month period in 2010 at our institute , were randomized to either group A ( n = 60 , GB retrieval through epigastric port ) or group B ( n = 60 , GB retrieval through umbilical port ) .
METHODS	VAS for pain was assessed by a registered nurse at 1 , 6 , 12 , 24 and 36 h after surgery .
RESULTS	The VAS for pain at umbilical port was less than epigastric port at 1 , 6 , 12 , 24 and 36 h after surgery ( 5.9 1.1 vs. 4.1 1.5 , 4.6 0.94 vs. 3.5 1.05 , 3.9 0.85 vs. 2.4 0.79 , 3.05 0.87 vs. 2.15 0.87 , respectively ) and the difference was statistically significant ( p-value < 0.001 ) .
RESULTS	Multiple linear regression was done for port site pain at 24 h and the VAS at umbilical port was less than epigastric port with VAS difference of 0.9 after adjusting for age , sex , duration of surgery and additional analgesia use ( r2 = 0.253 , p-value < 0.001 ) .
CONCLUSIONS	Gall bladder retrieval from umbilical port is associated with lower port site pain than GB retrieval from epigastric port in patients undergoing elective laparoscopic cholecystectomy .
CONCLUSIONS	We recommend umbilical port for gall bladder retrieval .

###16136765
BACKGROUND	The use of selective inhibitors of cyclooxygenase 2 ( COX-2 ) has been shown to be safe in patients with aspirin-induced asthma .
BACKGROUND	However , a few individuals with cutaneous reactions to nonsteroidal anti-inflammatory drugs ( NSAIDs ) experience urticaria or angioedema when challenged with various coxibs .
OBJECTIVE	To investigate the clinical tolerance of NSAID-sensitive individuals to the selective COX-2 inhibitors etoricoxib and celecoxib .
METHODS	Patients with NSAID-induced urticaria or angioedema were challenged in a double-masked , placebo-controlled design protocol with etoricoxib ( 120 mg ) and celecoxib ( 200 mg ) .
METHODS	Cutaneous , respiratory , and general symptoms ; vital signs ; and pulmonary function were monitored hourly for 3 hours .
RESULTS	Fifty-eight patients ( 46 females and 12 males ) with a mean + / - SD age of 31.7 + / - 14.1 years ( range , 13-66 years ) who showed urticaria or angioedema when challenged with NSAIDs were included in this study .
RESULTS	A cutaneous clinical pattern was observed in 34 patients ( 59 % ) , and a mixed pattern ( cutaneous and respiratory ) was seen in 24 ( 41 % ) .
RESULTS	Celecoxib provocation of 54 patients induced urticaria in 3 , urticaria and angioedema in 2 , and urticaria , rhinorrhea , and conjunctival erythema in 1 ( reaction rate , 11.1 % ) .
RESULTS	Etoricoxib challenges performed in 56 patients induced urticaria in 3 and angioedema in 1 ( reaction rate , 7.1 % ) .
CONCLUSIONS	These results confirm that most NSAID-sensitive individuals with cutaneous reactions to classic NSAIDs will tolerate specific COX-2 inhibitors , supporting the use of thesedrugs after careful oral provocation in such patients .

###22904246
BACKGROUND	Elderly nursing home residents are generally in poor health .
BACKGROUND	Many residents report pain on a daily basis , few are independent in their activities of daily living , and most take a large number of medications .
OBJECTIVE	To investigate the benefits elderly nursing home residents may receive from preventative osteopathic manipulative treatment ( OMT ) designed to optimize structure and function and enhance their bodies ' homeostatic mechanisms .
METHODS	Volunteer nursing home residents were randomly assigned to 1 of 3 groups : ( 1 ) OMT , ( 2 ) light touch ( LT ) , or ( 3 ) treatment as usual ( TAU ) .
METHODS	The OMT group received an OMT protocol twice per month for 5 months , for a total of 10 visits .
METHODS	The LT group received a light-touch protocol meant to simulate OMT at the same frequency as the OMT group .
METHODS	The TAU group received no intervention .
METHODS	Participant health information from Minimum Data Set assessments was monitored during the study , along with hospitalizations , emergency room visits , and outpatient procedures .
METHODS	The nursing home personnel and the participants ' attending physicians were blinded to treatment group assignment .
RESULTS	Twenty-one participants completed the study : 8 in the OMT group , 6 in the LT group , and 7 in the TAU group .
RESULTS	The OMT and LT groups had fewer hospitalizations ( P = .04 ) and decreased medication usage ( P = .001 ) compared with the TAU group .
CONCLUSIONS	Twice monthly OMT and LT protocols reduced the number of hospitalizations and decreased medication usage in elderly nursing home residents .

###15560813
OBJECTIVE	Plaque scoring usually employs subjective indices .
OBJECTIVE	The aim was to compare plaque inhibition of three toothpastes using two objective and one subjective measures of plaque .
METHODS	Formulations were : ( 1 ) an experimental anti-plaque paste ( test ) ; ( 2 ) an experimental paste ( minus active or negative control ) ; and ( 3 ) a proprietary anti-plaque toothpaste product ( positive control ) .
METHODS	The study was a blind , randomised crossover design using a 4-day , no tooth brushing , plaque regrowth model and involving 22 healthy subjects .
METHODS	After baseline plaque removal , subjects rinsed twice a day with slurries of the allocated paste .
METHODS	On day 5 , plaque was scored by index , wet weight and optical density of extracted disclosing solution from the plaque ( stain intensity ) .
RESULTS	All data showed the same pattern .
RESULTS	There were highly significant subject and treatment effects but not period effects .
RESULTS	The positive control was highly significantly more effective in plaque control than the test and minus active experimental formulations , which in turn were not significantly different from each other .
RESULTS	There were strong and significant correlations between pairs of scoring methods particularly wet weight and stain intensity .
CONCLUSIONS	The use of objective methods of plaque alongside conventional subjective indices provided convincing evidence for increased discriminatory power in a study comparing plaque inhibition by toothpastes .

###21805567
OBJECTIVE	This study aimed to test whether advanced cardiovascular injection ( ACI ) via 4 French ( Fr ) catheters is more advantageous than manual injection with 6 Fr catheters .
BACKGROUND	For coronary angiography , proponents of contrast media ACI believe it utilizes smaller-diameter catheters when compared with manual injection , without compromising the quality of the angiogram , and has the potential to reduce the amount of contrast used and lessen the use of closure devices .
METHODS	In a prospective study , 200 consecutive patients referred for elective coronary angiography were randomized to standard 6 Fr catheters with manual injection versus 4 Fr catheters with ACI .
METHODS	The study 's primary endpoint is the quality of the coronary angiogram .
METHODS	Secondary endpoints include groin complications , utilization of closure devices , and volume of contrast media .
METHODS	Thirty-six patients who underwent ad hoc percutaneous coronary intervention were excluded from the analysis .
RESULTS	The final analysis included 80 patients treated with 4 Fr catheters with ACI and 84 patients treated with 6 Fr catheters with manual injection .
RESULTS	The groups had similar demographic and clinical characteristics .
RESULTS	The quality of the angiogram was similar between groups with the exception of more left coronary sinus flush with 4 Fr catheters ( 3.57 1.1 vs. 2.98 0.9 , P < 0.001 ) and less closure device use with 4 Fr ( 25 vs. 71.4 % , P < 0.01 ) compared to 6 Fr catheters .
RESULTS	The procedure duration , volume of contrast used , vascular complications , and time to ambulation were similar between groups ( all P > 0.05 ) .
CONCLUSIONS	4 Fr diagnostic catheters with ACI offer similar quality coronary angiograms , similar rates of vascular complications , procedure duration , contrast used , and time to ambulation , but have a significantly lesser need for closure devices compared to the 6 Fr system with manual injection .

###8653994
OBJECTIVE	Oral contraceptive ( OC ) steroids alter the disposition of numerous drugs , including corticosteroids .
OBJECTIVE	We investigated the pharmacokinetics and pharmacodynamics of methylprednisolone .
METHODS	Twelve women ( six women used OC steroids and six women did not ) received intravenous methylprednisolone ( 0.6 mg/kg ideal body weight ) .
METHODS	Methylprednisolone disposition was assessed from plasma concentrations .
METHODS	Pharmacodynamic parameters measured were plasma cortisol , whole blood histamine ( reflecting basophils ) , and blood helper T lymphocytes .
RESULTS	Methylprednisolone clearance was significantly decreased in the women who used OC steroids ( 0.298 versus 0.447 L/hr/kg ) , resulting in a longer elimination half-life ( 2.20 versus 1.72 hours ) .
RESULTS	With use of indirect response models , significant differences were observed with the cortisol and basophil responses .
RESULTS	A larger value for the concentration that inhibits the zero-order production rate by 50 % ( 0.37 versus 0.11 ng/ml ) was observed in the women who used OC steroids for suppression of cortisol secretion , indicating less sensitivity to the suppressive effects of methylprednisolone .
RESULTS	Greater net suppression of basophils was observed in the users of OC steroids ( area under the response curve , 694 versus 401 ng x hr/ml ) .
RESULTS	No differences were observed for helper T-cell responses .
CONCLUSIONS	OC steroids appear to inhibit methylprednisolone metabolism .
CONCLUSIONS	However , mixed changes in several responses occur , indicating that women can probably receive similar doses of methylprednisolone irrespective of OC steroid use .

###16088404
OBJECTIVE	The purpose of this study was to compare the efficacy and toxicity of bendamustine , vincristine + prednisone ( BOP ) with a standard regimen of cyclophosphamide , vincristine + prednisone ( COP ) in patients with previously untreated advanced indolent non-Hodgkin 's lymphoma ( NHL ) and mantle cell lymphoma .
METHODS	A total of 164 patients with follicular lymphoma ( grade 1/2 ) , mantle cell lymphoma or lymphoplasmacytic lymphoma ( immunocytoma ) was randomised to treatment with vincristine 2 mg ( day 1 ) and prednisone 100 mg/m2 ( days 1-5 ) + bendamustine 60 mg/m2 ( days 1-5 ) or + cyclophosphamide 400 mg/m2 ( days 1-5 ) for a total of eight 21-day cycles .
RESULTS	The rate of complete remission was 22 % with BOP and 20 % with COP .
RESULTS	The projected 5-year survival rate was 61 % with BOP and 46 % with COP .
RESULTS	The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy ( 74 % vs. 56 % ; P = 0.05 ) , and did reach significance in responders who did not receive interferon maintenance therapy ( 70 % vs. 47 % ; P = 0.03 ) .
RESULTS	Toxicity was acceptable in both treatment groups , although alopecia and leucopenia were more severe with COP .
CONCLUSIONS	Bendamustine can efficaciously and safely replace cyclophosphamide , as used in standard COP therapy , for the treatment of patients with indolent NHL and mantle cell lymphoma .
CONCLUSIONS	Long-term survival data suggest a clinically significant benefit for patients treated with BOP .

###16440115
OBJECTIVE	To assess whether adrenocortical function was compromised in patients with active tuberculosis ( TB ) during the first 5 days of therapy with either a rifampicin-based or ciprofloxacin-based regimen .
METHODS	Patients were randomised into two groups of 10 each .
METHODS	Adrenocortical function was compared in both groups by the measurement of biochemical indices , electrolytes , osmolality and pituitary-adrenocortical hormones .
METHODS	Adrenal reserve was assessed by intravenous 250 mug adrenocorticotropin hormone ( ACTH ) stimulation tests .
METHODS	Department of Medicine , Johannesburg Hospital .
METHODS	Twenty hospitalised patients who were diagnosed with TB .
METHODS	Respiratory rate , pulse rate and blood pressure were recorded , and urinary sodium and osmolality were measured .
METHODS	Serum ACTH , cortisol , dehydroepiandrosterone - sulphate ( DHEA-S ) and aldosterone were assayed .
RESULTS	None of the patients demonstrated biochemical evidence of overt adrenal insufficiency .
RESULTS	There were no significant differences between the two groups before or during therapy for any biochemical indices , electrolytes , hormones or calculated osmolality .
RESULTS	Mean basal cortisol concentrations were substantially elevated and DHEA-S levels were consistently subnormal , resulting in a high cortisol / DHEA-S ratio .
RESULTS	In the ciprofloxacin group , cortisol responses to ACTH stimulation on day 1 were not significantly lower than on day 5 .
RESULTS	In the rifampicin group , cortisol concentrations decreased at each time point on day 5 compared with day 1 ( p = 0.001 ) .
RESULTS	However , a significantly higher mean incremental rise from the basal cortisol concentration was measured on day 5 at 60 minutes ( p = 0.04 ) .
RESULTS	In the entire cohort of 20 patients , 40 % demonstrated an incremental cortisol rise of < 250 nmol/l after ACTH stimulation on day 1 .
CONCLUSIONS	Rifampicin did not additionally impair adrenocortical function during the initial period of therapy .
CONCLUSIONS	The high cortisol/DHEA-S ratio might be of clinical relevance .

###10440606
BACKGROUND	The effect of acid secretion inhibitors in patients with functional dyspepsia ( FD ) is equivocal .
BACKGROUND	One previous trial showed an effect in patients with a characteristic gastro-oesophageal reflux pattern .
BACKGROUND	This double-blind trial compares the number of reflux episodes in responders and non-responders to omeprazole .
METHODS	Twenty-four patients ( men/women , 11:13 ; mean age , 49 years ) with FD were included ; those with reflux as the main symptom were excluded .
METHODS	An upper endoscopy and a 24-h oesophageal pH measurement were performed before randomization to treatment with 10-20 mg omeprazole or placebo for 4 weeks .
METHODS	Patients who at questioning considered themselves to have achieved sufficient relief of dyspeptic symptoms after 4 weeks were characterized as responders .
RESULTS	The number of responders in the omeprazole and placebo groups was 8 of 14 ( 57 % ) and 2 of 10 ( 20 % ) , respectively ( P = 0.07 ) .
RESULTS	The mean number of reflux episodes at the 24-h oesophageal pH measurement in responders and non-responders to omeprazole was 57 and 25 , respectively ( P < 0.003 ) .
RESULTS	In the omeprazole group the number of responders was 0 of 5 ( 0 % ) in those with < 32 reflux episodes and 8 of 9 ( 89 % ) in those with > 32 reflux episodes ( P < 0.003 ) .
CONCLUSIONS	Patients with FD responding to omeprazole were characterized by many reflux episodes .

###8922770
OBJECTIVE	To investigate whether a marginally hyperbaric tetracaine solution with or without phenylephrine could produce consistent blocks as compared with a conventionally hyperbaric tetracaine solution injected at L3-4 interspace with the patient in the lateral position .
METHODS	We studied 120 ASA I or II patients scheduled for elective surgery to the lower limb .
METHODS	Patients were randomly divided into four equal groups to receive spinal anaesthesia using tetracaine 0.5 % in glucose 0.75 % or 7.5 % , with or without phenylephrine 0.125 % .
METHODS	Neural block was assessed in a double-blind manner by cold , pinprick , and touch sensation , and a modified Bromage scale after the injection of the study drug .
RESULTS	The median ( 10th , 90th percentiles ) peak dermatomal level to pinprick obtained by the solutions in glucose 0.75 % was T10 ( L1 , T5 ) , which was lower than that obtained by the solution in glucose 7.5 % extending to T5 ( T10 , T3 ) and T5 ( T10 , T2 ) with or without phenylephrine , respectively ( P < 0.0001 ) .
RESULTS	The addition of phenylephrine prolonged the time to two-segment regression but did not change the maximum extent of blocks .
CONCLUSIONS	A marginally hyperbaric tetracaine with or without phenylephrine produced consistent blocks with spread restricted to the lower thoracic segments when administered intrathecally at the L3-4 interspace with the patient in the lateral position .

###7631730
OBJECTIVE	Our purpose was to determine the efficacy of transvaginal electrical stimulation in treating genuine stress incontinence .
METHODS	This was a multicenter , prospective , randomized , double-blind , placebo-controlled 15-week trial comparing the use of an active pelvic floor stimulator with a sham device .
METHODS	Thirty-five women used an active unit and 17 control subjects used sham devices .
METHODS	Weekly and daily voiding diaries were recorded throughout the trial .
METHODS	Urodynamic testing , including pad test and subtracted cystometry , was done before and at the end of device use .
METHODS	Pelvic muscle strength was measured at baseline and at the end of the trial .
METHODS	Patients scored their symptoms on visual analog scales and completed quality-of-life questionnaires before and after therapy .
RESULTS	Significant improvements from baseline were found in patients using active devices but not in controls .
RESULTS	Comparisons of changes from baseline between active-device and control patients showed that active-device patients had significantly greater improvement in weekly ( p = 0.009 ) and daily ( p = 0.04 ) leakage episodes , pad testing ( p = 0.005 ) , and vaginal muscle strength ( p = 0.02 ) when compared with control subjects .
RESULTS	Significantly greater improvement was also found for both visual analog scores of urinary incontinence ( p = 0.007 ) and stress incontinence ( p = 0.02 ) , as well as for subjective reporting of frequency of urine loss ( p = 0.002 ) , and urine loss with sneezing , coughing , or laughing ( p = 0.02 ) , when compared with controls .
RESULTS	Pad testing showed that stress incontinence was improved by at least 50 % in 62 % of patients using an active device compared with only 19 % of patients using sham devices ( p = 0.01 ) .
RESULTS	Voiding diaries showed at least 50 % improvement in 48 % of active-device patients compared with 13 % of women using the sham device ( p = 0.02 ) .
RESULTS	No irreversible adverse effects were noted in either group .
CONCLUSIONS	Transvaginal pelvic floor electrical stimulation was found to be a safe and effective therapy for genuine stress incontinence .

###7505423
OBJECTIVE	To determine the effects of large doses of aspartame on behavior , cognition , and monoamine metabolism in children with attention deficit disorder .
METHODS	A randomized , double-blind , placebo-controlled crossover study of unmedicated children meeting Diagnostic and Statistical Manual of Mental Disorders ( 3rd ed ) criteria for attention deficit disorder .
METHODS	Behavioral assessments were performed in the child 's home by their parents and in the classroom by a teacher .
METHODS	Cognitive tests were administered and blood drawing was performed during a 2-day inpatient admission to our Children 's Study Center .
METHODS	Administration of aspartame ( single morning dose , 34 mg/kg ) or placebo for alternate 2-week periods .
METHODS	Behavioral and cognitive tests included the Matching Familiar Figures Test ( MFFT ) , Children 's Checking Task ( CCT ) , the Airplane Test , the Wisconsin Card Sorting Test ( WCST ) , the Subjects Treatment Emergent Symptom Scale ( STESS ) , the Multigrade Inventory for Teachers ( MIT ) , and the Conners Behavior Rating Scale .
METHODS	Blood was drawn for complete blood cell count and liver function tests , as well as amino acid , methanol , formate , serotonin , and monoamine metabolite analyses , and urine was collected for measurement of catecholamine and monoamine metabolite excretion .
RESULTS	No clinically significant differences between aspartame and placebo were found for the STESS , MIT , or Conners ratings , or for the MFFT , CCT , WCST , or Airplane cognition tests .
RESULTS	Also , no differences were noted for any of the biochemical measures , except for the expected increase in plasma phenylalanine and tyrosine following aspartame .
CONCLUSIONS	The findings indicate that aspartame at greater than 10 times usual consumption has no effect on the cognitive and behavioral status of children with attention deficit disorder .
CONCLUSIONS	In addition , aspartame does not appear to affect urinary excretion rates of monoamines and metabolites .

###11505349
OBJECTIVE	To investigate the anti-inflammatory and hemodynamic effects of 17beta-estradiol in men undergoing elective coronary artery bypass graft surgery ( CABG ) .
METHODS	Prospective , randomized , controlled .
METHODS	Operating room and intensive care unit in a university hospital .
METHODS	Twenty-one men undergoing primary , elective CABG surgery .
METHODS	17beta-estradiol , 2mg , was given orally twice in 14 hours before the operation .
RESULTS	Leukocyte counts , plasma myeloperoxidase , tumor necrosis factor-alpha , interleukin ( IL ) -6 , IL-8 , and IL-10 were measured perioperatively .
RESULTS	Leukocyte counts were lower in the 17beta-estradiol group than in controls at 6 hours ( 11.4 + / - 2.0 hours v 15.5 + / - 4.7 hours x 10 ( 9 ) / L ) and 20 hours ( 11.6 + / - 1.9 hours v 13.6 + / - 2.5 hours x 10 ( 9 ) / L ) after reperfusion ( p = 0.03 ) .
RESULTS	The release of myeloperoxidase was lower in the 17beta-estradiol group than in controls ( 5 minutes ; 634.4 + / - 213.1 microg/mL v 773.1 + / - 209.3 microg/mL ; 4 hours , 305.0 + / - 108.0 microg/mL v 441.3 + / - 191.6 microg/mL ; p = 0.02 ) .
RESULTS	Systemic vascular resistance index was lower just after cardiopulmonary bypass , and cardiac index was higher postoperatively in the 17beta-estradiol group as compared with controls .
CONCLUSIONS	Pretreatment with 17beta-estradiol can limit leukocyte activation in men after CABG surgery .

###14560228
OBJECTIVE	We evaluated the safety and efficacy of the fibrin sealant Beriplast P ( FSBP ; Aventis-Behring ) for hemostasis in anastomosis of polytetrafluoroethylene ( PTFE ) grafts to the femoral artery .
METHODS	In a single-blinded randomized prospective multicenter clinical trial , FSBP was compared with thrombin-soaked gelatin sponge ( TSG ) for efficacy in stopping bleeding from needle or suture holes in PTFE grafts after anastomosis to the femoral artery .
METHODS	Patients were randomized to FSBP application , which requires a 3-minute period of arterial clamping to enable the fibrin clot to adhere , or to TSG application , which requires pressure from gauze sponges , after completion of the femoral artery anastomosis .
METHODS	The primary end point was hemostasis , defined as absence of any detectable bleeding as judged by the operating surgeon , by 4 minutes after randomization .
METHODS	Secondary end points included actual time from randomization to hemostasis , time to beginning of wound closure , measured blood loss ( weighed sponges ) , incidence of recurrent bleeding , stay in the intensive care unit , and hospital length of stay .
METHODS	Data were analyzed with the intention-to-treat method .
RESULTS	Two hundred thirty-five subjects were enrolled at 26 medical centers ; 34 were subsequently excluded from the study .
RESULTS	Of the 201 randomized subjects , 100 received FSBP and 99 received TSG .
RESULTS	Hemostasis was achieved by 4 minutes in 64 subjects ( 63 % ) in the FSBP group and 40 subjects ( 40 % ) in the TSG group ( P = .0018 ) .
RESULTS	In the FSBP group , compared with the TSG group , time to hemostasis was shorter ( median , 4.0 minutes ; 95 % confidence interval [ CI ] , 3.8-4 .18 minutes vs median , 5.6 minutes , 95 % CI , 4.5-7 .0 ; P = .008 ) , blood loss was less ( mean , 4.0 + / - 29.7 g vs mean , 15.6 + / - 28.4 g ; P < .0001 ) , and time to wound closure was shorter ( median , 15 minutes ; 95 % CI , 10.47-18 .67 minutes vs median , 22.8 minutes ; 95 % CI , 18.67-30 .67 ; P = .005 ) .
RESULTS	There were no differences in recurrent bleeding or any other adverse events .
RESULTS	There was no significant difference in ICU stay , but hospital length of stay was shorter in the FSBP group compared with the TSG group , and the difference approached significance ( median , 6.5 days ; 95 % CI , 5.00-7 .00 days vs median , 7.0 days ; 95 % CI , .
RESULTS	6.00-8 .00 days ; P = .0565 ) .
CONCLUSIONS	FSBP is more effective than TSG for achieving hemostasis of needle or suture hole bleeding from PTFE femoral artery grafts .

###16221141
OBJECTIVE	In vivo confocal laser scanning microscopy ( CLSM ) is a new method that provides skin images in horizontal plane at a level of resolution that allows to view microanatomic structures .
OBJECTIVE	This study examines whether certain digital image-processing steps can increase the visibility of various structures in CLSM .
METHODS	Fifty images were taken from normal skin of 25 probands , and 39 image enhancement procedures were created .
METHODS	Eight procedures that seemed to provide some quality enhancement were deliberately selected for further evaluation .
METHODS	Subsequently , a collection of random pairs of the original image and an image submitted to any of the eight selected procedures was rated by five independent observers .
RESULTS	In three of the eight procedures tested , the modified image was significantly preferred to the original image ( chi2-test , : P < or = 0.001 ) .
RESULTS	In particular , smoothing , shading correction , delineate and grey-level normalization in various combinations were helpful in showing the characteristic honeycomb pattern , pigmented basal cell layer , cell borders and the nuclei more clearly .
CONCLUSIONS	Digital image processing may help to increase visibility of in vivo CLSM images .

###16634959
OBJECTIVE	This randomized clinical trial presents a 12-month follow-up of the clinical and microbiological results after application of minocycline microspheres as an adjunct to mechanical treatment of incipient peri-implant infections compared with an adjunctive treatment using 1 % chlorhexidine gel application .
METHODS	Thirty-two subjects with probing depth > or = 4 mm , combined with bleeding and/or exudate on probing and presence of putative pathogenic bacteria were given oral hygiene instructions and mechanical treatment of infected areas adjacent to implants .
METHODS	The subjects were then randomly assigned adjunctive subgingival antimicrobial treatment using either chlorhexidine gel or minocycline microspheres .
METHODS	Sixteen patients in the minocycline group and 14 in the chlorhexidine group completed the study .
METHODS	Follow-up examinations were carried out after 10 days , 1 , 2 , 3 , 6 , 9 and 12 months .
RESULTS	The adjunctive use of minocycline microspheres resulted in improvements of probing depths and bleeding scores , whereas the adjunctive use of chlorhexidine only resulted in limited reduction of bleeding scores .
RESULTS	For the deepest sites of the treated implants in the minocycline group , the mean probing depth was reduced from 5.0 to 4.4 mm at 12 months .
RESULTS	This study could not show any significant difference in the levels of bacterial species or groups at any time point between the two antimicrobial agents tested .
RESULTS	The present findings encourage further studies on adjunctive use of minocycline microspheres in the treatment of peri-implant lesions .
CONCLUSIONS	The use of a local antibiotic as an adjunct to mechanical treatment of incipient peri-implantitis lesions demonstrated improvements in probing depths that were sustained over 12 months .

###16650261
BACKGROUND	In patients with common atrial flutter ( CAF ) , radiofrequency ablation ( RFA ) causes discomfort .
BACKGROUND	Patients undergoing RFA often feel pain which is difficult to control as the mechanisms are unclear .
OBJECTIVE	Inhaled nitrous oxide ( N2O ) is a potent sedative-analgesic-anxiolytic agent that may relieve anxiety and discomfort during CAF ablation .
RESULTS	In a prospective randomized study , the effect of Inhaled N2O was compared with that of intravenous sedation with Nalbuphine during CAF ablation in 76 patients ( 64 + / - 13 years , 56 men ) .
RESULTS	We used a 24 pole mapping catheter around the tricuspid annulus and a 8-mm tip ablation catheter for each patient .
RESULTS	Forty-two patients ( group 1 ) underwent radiofrequency ( RF ) application to the cavotricuspid isthmus 5 minutes after the beginning of inhalation of a ( 50 % N2O/50 % O2 ) mixture .
RESULTS	Thirty-four patients ( group 2 ) , underwent the first RF application 15 minutes after the end of an infusion of Nalbuphine ( 20 mg delivered over 15 minutes ) .
RESULTS	Ablation-related anxiety and discomfort were assessed using a visual analog scale ( VAS ) ranging from 0 to 100 mm , with 0 correlating to the statement `` no pain at all '' and 100 with `` the worst possible pain . ''
RESULTS	The VAS score was determined at the end of each application .
RESULTS	The number of RF applications ( group 1 ; 10 + / - 8 vs group 2 ; 11 + / - 6 , P = NS ) and procedure duration ( group 1 ; 75 + / - 53 minutes vs group 2 ; 72 + / - 45 minutes , P = NS ) , were similar for the two groups .
RESULTS	N ( 2 ) O sedation compared with nalbuphine infusion reduced VAS for anxiety ( 10 mm + / - 8 vs 58 mm + / - 22 , P < 0.05 ) and for discomfort ( 18 mm + / - 9 vs 45 mm + / - 34 , P < 0.01 ) , respectively .
RESULTS	Although there was more frequent vomiting in group 1 ; 7 of 42 ( 17 % ) than in group 2 ; 3 of 34 ( 9 % ) , P < 0.05 , patients were less likely to have hypotension during the procedure 1 of 42 ( 2.5 % ) versus 4 of 34 ( 12 % ) , P < 0.05 , respectively .
CONCLUSIONS	Inhalation of a ( 50 % N2O/50 % O2 ) mixture during RF ablation for atrial flutter is a safe and efficient way to reduce anxiety and discomfort caused by RF applications .

###11910660
OBJECTIVE	To determine the prevalence of uterine and endometrial abnormalities in normal postmenopausal women and assess the accuracy of subjective hysteroscopic appearances and endometrial histology following 12 weeks of hormonal treatment .
METHODS	A multicentered randomized double-blind placebo-controlled trial in which the volunteers received conjugated equine estrogen 0.625 mg , selective estrogen receptor modulator ( in one of two doses ) or placebo .
METHODS	Out-patient endoscopy unit in a large teaching hospital .
METHODS	Out-patient hysteroscopy and endometrial biopsy .
RESULTS	Forty-eight women had a hysteroscopy and endometrial biopsy : eight ( 16.6 % ; 95 % confidence interval , CI 6-27 % ) women had intrauterine polyps and 38 ( 79.2 % ) women had normal hysteroscopies .
RESULTS	Thirty-five women had a repeat endometrial assessment with hysteroscopy and , for the detection of proliferative endometrium ( prevalence 22.8 % ) , a sensitivity of 87.5 % , a specificity of 74 % , a negative predictive value of 95 % and a positive predictive value of 50 % were observed .
RESULTS	There was a good proportion of agreement , 0.77 ( 95 % CI 0.63-0 .91 ) , but a kappa score of 0.486 revealed only a moderate level of agreement .
RESULTS	The likelihood ratios for proliferative endometrium were : LHR + = 3.38 ( fair ) , and LHR - = 0.17 ( moderate ) .
CONCLUSIONS	Hysteroscopic assessment of the uterine cavity is efficient in the detection of pathological intrauterine lesions , but is only moderately successful in determining physiological changes in the endometrium .
CONCLUSIONS	This study defines a standard of observational statistics for out-patient hysteroscopy in relation to normal endometrial histology in postmenopausal women who may have been ingesting exogenous estrogens .

###2126198
OBJECTIVE	To study the effect of long-term continuous combined oestrogen/progestogen therapy on calcium metabolism , lipoproteins , and bleeding pattern in early postmenopausal women .
METHODS	A prospective , open , controlled study .
METHODS	After initial examinations , control examinations were performed every three months for the first two years and every year for the following three ( two ) years , with determinations of bone mass , serum lipoproteins , and bleeding pattern .
METHODS	Out-patient research clinic at The Department of Clinical Chemistry , Glostrup Hospital , Denmark .
METHODS	Eighteen healthy women between 6 months and 3 years after a natural menopause , entered in a trial of continuous long-term hormone replacement therapy and a comparison group of 19 age-matched untreated women .
METHODS	The treated group received 2 mg of 17 beta-oestradiol combined with 1 mg of norethisterone acetate orally each day continuously for 5 years with a 3 month therapy-free interval after the first 2 years .
METHODS	The women were investigated before treatment , then every 3 months for the first 2 years and every year for the next 3 years for determinations of bone mass , serum lipoproteins and bleeding patterns .
METHODS	The comparison group was followed-up in parallel for the first 4 years .
METHODS	Forearm bone mass was measured with single photon absorptiometry .
METHODS	Blood and urine samples were taken in the morning after an overnight fast and tobacco abstinence .
METHODS	The effects of hormone therapy on bone mineral content in the forearm , on serum and urine indices of calcium metabolism , on serum levels of total , high ( HDL-C ) and low ( LDL-C ) density lipoprotein cholesterol , and bleeding pattern .
RESULTS	Bone mineral content in the forearm was stable during the 5 years of treatment , whereas it declined significantly averaging 10 % after 4 years in the comparison group .
RESULTS	The biochemical estimates of bone turnover decreased to premenopausal level in the hormone group , whereas they remained at a high level in the comparison group .
RESULTS	In the hormone group total cholesterol and LDL-C decreased by 20 % whereas HDL-C was virtually unchanged .
RESULTS	The treatment was associated with minor irregular bleeding in nine women during the first 6 months of treatment , after which no bleeding was experienced .
CONCLUSIONS	Continuous combined oestrogen/progestogen therapy can keep early postmenopausal women free of bleeding episodes for a period of 5 years , after the first 6 months in which spotting occurs in 25 % .
CONCLUSIONS	The therapy prevented bone loss completely .
CONCLUSIONS	The changes in serum lipoproteins were concordant with a lipid profile associated with a decreased risk of coronary heart disease .

###15735611
OBJECTIVE	The purpose of this study was to elucidate the potential clinical relevance and mechanism ( s ) of action of 2 different volumes of grapefruit juice on the reduction of bioavailability of fexofenadine , a substrate of organic anion transporting polypeptides .
METHODS	Grapefruit juice or water at normal ( 300 mL ) or high ( 1200 mL ) volume was ingested concomitantly with 120 mg fexofenadine by 12 healthy volunteers in a randomized 4-way crossover study , and fexofenadine pharmacokinetics were determined over a period of 8 hours .
RESULTS	The 300-mL volume of grapefruit juice decreased the mean area under the plasma drug concentration-time curve ( AUC ) and the peak plasma drug concentration of fexofenadine to 58 % ( P < .001 ) and 53 % ( P < .001 ) , respectively , of those with the corresponding volume of water , and 1200 mL grapefruit juice reduced these parameters to 36 % ( P < .001 ) and 33 % ( P < .001 ) , respectively , of those with the corresponding volume of water .
RESULTS	The 300-mL volume of grapefruit juice diminished the AUC of fexofenadine variably among individuals .
RESULTS	This decline correlated with baseline AUC of fexofenadine with water at equivalent volume ( r ( 2 ) = 0.97 , P < .0001 ) .
RESULTS	The 1200-mL volume of grapefruit juice decreased the AUC of fexofenadine more than the 300-mL volume of grapefruit juice compared with the corresponding volume of water in each subject by a constant amount .
RESULTS	Grapefruit juice , 300 mL and 1200 mL , reduced the coefficient of variation of the AUC of fexofenadine by 2-fold compared with that with a matching volume of water .
CONCLUSIONS	Grapefruit juice at a commonly consumed volume diminished the oral bioavailability of fexofenadine sufficiently to be pertinent clinically , likely by direct inhibition of uptake by intestinal organic anion transporting polypeptide A ( OATP-A ; new nomenclature , OATP1A2 ) .
CONCLUSIONS	A much higher volume caused an additional modest effect , possibly from reduced intestinal concentration and transit time of fexofenadine .
CONCLUSIONS	This food-drug interaction appears to be novel and may be relevant to other fruit juices and drugs .

###14722034
OBJECTIVE	To evaluate the outcome of elderly patients with head and neck cancer undergoing palliative chemotherapy .
METHODS	We analyzed combined data from two mature phase III randomized trials conducted by the Eastern Cooperative Oncology Group ( ECOG ; trial E1393 , which compared cisplatin plus paclitaxel at two dose levels , and trial E1395 , which compared cisplatin plus fluorouracil to cisplatin plus paclitaxel ) to evaluate the toxicity , objective response rates , and survival of patients 70 years or older versus their younger counterparts .
METHODS	All patients had previously untreated recurrent or metastatic squamous cell carcinoma of the head and neck and ECOG performance status 0 or 1 .
RESULTS	Fifty-three elderly patients were enrolled from a total of 399 eligible participants ( 13 % ) .
RESULTS	Elderly patients had similar objective response rates ( 28 % v 33 % ) and median time to progression ( 5.25 v 4.8 months ) compared with younger patients .
RESULTS	The median survival was 5.3 v 8 months ( Wilcoxon P = .06 ; log-rank P = .17 ) and the 1-year survival 26 % v 33 % for elderly and younger patients , respectively .
RESULTS	Elderly patients had a significantly higher incidence of severe nephrotoxicity , diarrhea , and thrombocytopenia .
RESULTS	A higher rate of toxic deaths was noted in the elderly but did not reach statistical significance ( 13 % v 8 % ; P = .29 ) .
CONCLUSIONS	Elderly patients were underrepresented in these studies .
CONCLUSIONS	Fit elderly patients with recurrent or metastatic head and neck cancer sustained increased toxicities with cisplatin-based doublets but had comparable survival outcomes compared with younger patients .
CONCLUSIONS	Strategies to ameliorate toxicities should be pursued in the elderly .

###15341354
BACKGROUND	The aim of the present study was to compare the effectiveness of an Er : YAG laser to that of ultrasonic scaling for non-surgical periodontal treatment .
METHODS	Twenty patients with moderate to advanced periodontal disease were randomly treated in a split-mouth design with a single episode of subgingival debridement using either an Er : YAG laser device ( 160 mJ/pulse , 10 Hz ) combined with a calculus detection system with fluorescence induced by 655 nm InGaAsP diode laser radiation ( ERL ) , or an ultrasonic instrument ( UI ) .
METHODS	Clinical assessments of full-mouth plaque score ( FMPS ) , bleeding on probing ( BOP ) , probing depth ( PD ) , gingival recession ( GR ) , and clinical attachment level ( CAL ) were made at baseline and at 3 and 6 months following therapy .
RESULTS	No differences in any of the investigated parameters were observed at baseline between the two groups .
RESULTS	The mean value of BOP decreased in the ERL group from 40 % at baseline to 17 % after 6 months ( P < 0.0001 ) and in the UI group from 46 % at baseline to 15 % after 6 months ( P < 0.0001 ) .
RESULTS	The sites treated with ERL demonstrated mean CAL gain of 1.48 + / - 0.73 mm ( P < 0.001 ) and of 1.11 + / - 0.59 mm ( P < 0.001 ) at 3 and 6 months , respectively .
RESULTS	The sites treated with UI demonstrated mean CAL gain of 1.53 + / - 0.67 mm ( P < 0.001 ) and of 1.11 + / - 0.46 mm ( P < 0.001 ) at 3 and 6 months , respectively .
RESULTS	No statistically significant differences were observed between the groups ( P > 0.05 ) .
CONCLUSIONS	Within the limits of the present study , it can be concluded that both therapies led to significant improvements of the investigated clinical parameters .

###25058680
OBJECTIVE	The objective of this study was to assess the 48-week virological efficacy of atazanavir/ritonavir ( ATV/r ) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase ( NRTIs ) in HIV-1 treated individuals with HIV-RNA less than 50copies/ml .
METHODS	A multicentre , randomized , open-label , noninferiority trial .
METHODS	HIV-1 treated individuals on ATV/r 300/100mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen .
METHODS	The primary endpoint was the confirmed viral rebound ( CVR : two consecutive HIV-RNA > 50copies/ml ) or treatment discontinuation for any reason .
METHODS	Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than 50copies/ml after 12 weeks since reintensification .
RESULTS	One hundred and three patients enrolled .
RESULTS	By week 48 , 11 patients in ATV/r arm and two in ATV/r along with two NRTIs experienced CVR ; four ( 8 % ) patients in ATV/r and eight ( 15 % ) in ATV/r along with two NRTIs discontinued .
RESULTS	At the 48-week primary efficacy analysis ( re-intensification = failure ) , treatment success was 73 % in ATV/r arm and 85 % in ATV/r along with two NRTIs [ difference -12.1 % , 95 % confidence interval ( 95 % CI ) -27.8 to 2.1 ] .
RESULTS	According to the analysis considering re-intensification is equal to success , treatment success was 92 % in ATV/r arm and 85 % in the ATV/r along with two NRTIs arm ( difference 7.5 % , 95 % CI -4.7 to 19.8 ) .
RESULTS	At CVR , no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals .
RESULTS	Overall , Grade 3-4 ( P = 0.003 ) and grade 3-4 drug-related ( P = 0.027 ) adverse events were less frequent in ATV/r arm .
RESULTS	A significant increase in total and low-density lipoprotein ( LDL ) - cholesterol was observed as well as a significant improvement in high-density lipoprotein ( HDL ) - cholesterol , fasting glucose , liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs .
CONCLUSIONS	ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy ; NRTIs reintroduction was effective in all the individuals .

###9097338
BACKGROUND	This study examined the effects of an 8-week stress reduction program based on training in mindfulness meditation .
BACKGROUND	Previous research efforts suggesting this program may be beneficial in terms of reducing stress-related symptomatology and helping patients cope with chronic pain have been limited by a lack of adequate comparison control group .
METHODS	Twenty-eight individuals who volunteered to participate in the present study were randomized into either an experimental group or a nonintervention control group .
RESULTS	Following participation , experimental subjects , when compared with controls , evidenced significantly greater changes in terms of : ( 1 ) reductions in overall psychological symptomatology ; ( 2 ) increase in overall domain-specific sense of control and utilization of an accepting or yielding mode of control in their lives , and ( 3 ) higher scores on a measure of spiritual experiences .
CONCLUSIONS	The techniques of mindfulness meditation , with their emphasis on developing detached observation and awareness of the contents of consciousness , may represent a powerful cognitive behavioral coping strategy for transforming the ways in which we respond to life events .
CONCLUSIONS	They may also have potential for relapse prevention in affective disorders .

###23128283
BACKGROUND	Adequate control of blood pressure reduces the risk of recurrent stroke .
BACKGROUND	We conducted a randomized controlled study to determine whether home blood pressure monitoring with nurse-led telephone support would reduce blood pressure in patients with hypertension and a history of stroke .
METHODS	We recruited 381 participants ( mean age 72 years ) from outpatient and inpatient stroke clinics between Mar. 1 , 2007 , and Aug. 31 , 2009 .
METHODS	Nearly half ( 45 % , 170 ) of the participants had some disability due to stroke .
METHODS	Participants were visited at home for a baseline assessment and randomly allocated to home blood pressure monitoring ( n = 187 ) or usual care ( n = 194 ) .
METHODS	Those in the intervention group were given a monitor , brief training and telephone support .
METHODS	Participants who had home blood pressure readings consistently over target ( target < 130/80 mm Hg ) were advised to consult their family physician .
METHODS	The main outcome measure was a fall in systolic blood pressure after 12 months , measured by an independent researcher unaware of group allocation .
RESULTS	Despite more patients in the intervention group than in the control group having changes to antihypertensive treatment during the trial period ( 60.1 % [ 98/163 ] v. 47.6 % [ 78/164 ] , p = 0.02 ) , the fall in systolic blood pressure from baseline did not differ significantly between the groups ( adjusted mean difference 0.3 mm Hg , 95 % confidence interval -3.6 to 4.2 mm Hg ) .
RESULTS	Subgroup analysis showed significant interaction with disability due to stroke ( p = 0.03 at 6 months ) and baseline blood pressure ( p = 0.03 at 12 months ) .
CONCLUSIONS	Overall , home monitoring did not improve blood pressure control in patients with hypertension and a history of stroke .
CONCLUSIONS	It was associated with a fall in systolic pressure in patients who had uncontrolled blood pressure at baseline and those without disability due to stroke .
BACKGROUND	ClinicalTrials.gov registration NCT00514800 .

###15808246
OBJECTIVE	To compare the efficacy and efficiency of retrobulbar versus sub-Tenon 's capsule injection of local anesthetic in vitreoretinal surgery .
METHODS	Prospective , randomized , double-masked clinical trial .
METHODS	Sixty-four eyes from 61 patients undergoing vitreoretinal surgery were randomized to receive either retrobulbar or sub-Tenon 's capsule injection of 5 ml of a 50:50 mixture of 4 % lidocaine and 0.75 % bupivacaine .
METHODS	The primary outcome measured was intraoperative eye pain , which was rated by patients in both groups using an 11-point ( 0-10 ) numerical visual analogue scale immediately after surgery and again the next morning .
METHODS	The surgeons indicated whether they perceived patient discomfort during 4 different stages of the operation : opening of the conjunctiva , vitrectomy ( if performed ) , placement of scleral buckle ( if performed ) , and closing of the conjunctiva .
METHODS	The preincision time , need for supplemental local anesthesia , and use of IV sedation for additional pain control were compared between the two groups .
RESULTS	Thirty-four eyes were randomized to retrobulbar injections , and 30 eyes were randomized to sub-Tenon 's capsule injections .
RESULTS	There was no significant difference in patient-reported intraoperative pain scores between the retrobulbar and sub-Tenon 's capsule groups when assessed immediately after surgery ( median , 2.0 vs. 2.0 ; P = 0.52 ) or the next day ( median , 2.0 vs. 1.0 ; P = 0.26 ) .
RESULTS	The surgeons reported no difference between the two groups in terms of the percentages of patients with pain during opening of the conjunctiva ( 20.6 % vs. 3.3 % ; P = 0.058 ) , vitrectomy ( 31 % vs. 32 % ; P = 1.00 ) , placement of scleral buckle ( 33.3 % vs. 40 % ; P = 1.00 ) , and closing of the conjunctiva ( 26.5 % vs. 26.7 % ; P = 1.00 ) .
RESULTS	There was a suggestion that preincision time was longer in the sub-Tenon 's capsule group .
RESULTS	Approximately equal percentages of patients in each group required supplemental local anesthesia ( 38 % vs. 37 % ; P = 0.90 ) or IV medication ( 85 % vs. 70 % ; P = 0.14 ) for pain control .
CONCLUSIONS	Sub-Tenon 's capsule injection of local anesthetic seems as effective as retrobulbar injection at controlling intraoperative pain in vitreoretinal surgery .

###24613333
OBJECTIVE	A post-approval ( PA ) study for destination therapy ( DT ) was required by the Food and Drug Administration ( FDA ) to determine whether results with the HeartMate ( HM ) II ( Thoratec , Pleasanton , California ) left ventricular assist device ( LVAD ) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial .
BACKGROUND	New device technology developed in the clinical research setting requires validation in a real-world setting .
METHODS	The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS ( Interagency Registry for Mechanically Assisted Circulatory Support ) registry .
METHODS	Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years .
METHODS	A historical comparison group included patients ( n = 133 at 34 centers ) enrolled in the primary data cohort in the DT pivotal trial ( TR ) .
METHODS	Survival rates and adverse events for the PA group were obtained from the INTERMACS registry .
RESULTS	Baseline characteristics were similar for PA versus TR .
RESULTS	Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28 % were in profile 3 .
RESULTS	Adverse events in the PA group were similar or lower than those in the TR group , including improvements in device-related infection ( 0.22 vs. 0.47 ) and post-operative bleeding requiring surgery ( 0.09 vs. 0.23 ) events per patient-year .
RESULTS	Kaplan-Meier survival at 2 years was 62 % ( PA group ) versus 58 % ( TR group ) .
RESULTS	PA group survival at 1 and 2 years was 82 5 % and 69 6 % for INTERMACS profiles 4 to 7 ( n = 63 ) versus 72 3 % and 60 4 % for profiles 1 to 3 ( n = 184 ) .
RESULTS	The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group .
CONCLUSIONS	Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD .
CONCLUSIONS	Survival was best in patients who were not inotrope-dependent ( INTERMACS profiles 4 to 7 ) .

###20093905
OBJECTIVE	To investigate morphological and functional changes after pelvic floor muscle training in women with pelvic organ prolapse .
METHODS	This randomized controlled trial was conducted at a university hospital and a physical therapy clinic .
METHODS	One hundred nine women with pelvic organ prolapse stages I , II , and III were randomly allocated by a computer-generated random number system to pelvic floor muscle training ( n = 59 ) or control ( n = 50 ) .
METHODS	Both groups received lifestyle advice and learned to contract the pelvic floor muscles before and during increases in intraabdominal pressure .
METHODS	In addition the pelvic floor muscle training group did individual strength training with a physical therapist and daily home exercise for 6 months .
METHODS	Primary outcome measures were pelvic floor muscle ( pubovisceral muscle ) thickness , levator hiatus area , pubovisceral muscle length at rest and Valsalva , and resting position of bladder and rectum , measured by three-dimensional ultrasonography .
RESULTS	Seventy-nine percent of women in the pelvic floor muscle training group adhered to at least 80 % of the training protocol .
RESULTS	Compared with women in the control group , women in the pelvic floor muscle training group increased muscle thickness ( difference between groups : 1.9 mm , 95 % confidence interval [ CI ] 1.1-2 .7 , P < .001 ) , decreased hiatal area ( 1.8 cm , 95 % CI 0.4-3 .1 , P = .026 ) , shortened muscle length ( 6.1 mm , 95 % CI 1.5-10 .7 , P = .007 ) , and elevated the position of the bladder ( 4.3 mm , 95 % CI 2.1-6 .5 , P < .000 ) and rectum ( 6.7 mm , 95 % CI 2.2-11 .8 , P = .007 ) .
RESULTS	Additionally , they reduced the hiatal area and muscle length at maximum Valsalva indicating increased pelvic floor muscle stiffness .
CONCLUSIONS	Supervised pelvic floor muscle training can increase muscle volume , close the levator hiatus , shorten muscle length , and elevate the resting position of the bladder and rectum .
BACKGROUND	www.clinicaltrials.gov , NCT00271297 .
METHODS	I.

###10521751
OBJECTIVE	The object of the study was to determine whether time of day , interval after a standard meal , and maternal body mass influence plasma glucose concentrations in women with gestational diabetes mellitus .
METHODS	Identical mixed meals were administered on 2 separate occasions 1 week apart to 30 women with dietarily treated gestational diabetes and pregnancies between 28 and 38 weeks ' gestation .
METHODS	One meal was administered at 7 AM ( morning meal ) and the other was administered at 9 PM ( evening meal ) , each after a fast of > / = 5 hours .
METHODS	The order of the meals ( morning first versus evening first ) was assigned randomly .
METHODS	Sixteen of the women had a body mass index > / = 27 kg/m ( 2 ) ( overweight ) and 14 women had a body mass index < 27 kg/m ( 2 ) ( lean ) .
METHODS	Venous plasma concentrations of glucose , insulin , free fatty acids , beta-hydroxybutyrate , and bound and free cortisol were measured hourly for 9 hours after each of the test meals .
RESULTS	When all women were considered together glucose concentrations after the morning meal were significantly greater at 1 hour , were not different at 2 hours , and were significantly lower from 3 through 9 hours postprandially than those at corresponding times after the evening meal .
RESULTS	Plasma beta-hydroxybutyrate and free fatty acid concentrations were higher between 5 and 9 hours after the morning meal than at the same times after the evening meal .
RESULTS	Total and free cortisol levels were higher for the first 7 hours after the morning feeding , reflecting known diurnal variation in cortisol concentrations .
RESULTS	Overweight patients ' glucose values were significantly greater than those of lean subjects during the last 4 hours of the overnight fast .
CONCLUSIONS	Among women with dietarily treated gestational diabetes the glucose concentrations were significantly higher from 3 to 9 hours after an evening meal , whereas suppression of free fatty acids and beta-hydroxybutyrate was less sustained after a morning feeding .
CONCLUSIONS	The mechanisms underlying these differences remain to be determined but may involve diurnal influences of counterregulatory hormones .
CONCLUSIONS	The relationships between measurements of maternal glycemia and maternal and perinatal outcomes in pregnancies complicated by gestational diabetes may be clarified by establishing a uniform duration of a fast and by developing meal-specific preprandial and postprandial maternal glucose targets for these patients .

###22929209
BACKGROUND	Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings .
OBJECTIVE	We evaluated the cost effectiveness of two weight loss programmes of 1-year duration , either standard care ( SC ) as defined by national guidelines , or a commercial provider ( Weight Watchers ) ( CP ) .
METHODS	This analysis was based on a randomised controlled trial of 772 adults ( 87 % female ; age 47.412.9 years ; body mass index 31.42.6 kgm ( -2 ) ) recruited by health professionals in primary care in Australia , United Kingdom and Germany .
METHODS	Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER , expressed as the cost per quality adjusted life year ( QALY ) .
RESULTS	The cost per kilogram of weight loss was USD122 , 90 and 180 for the CP in Australia , the United Kingdom and Germany , respectively .
RESULTS	For SC the cost was USD138 , 151 and 133 , respectively .
RESULTS	From a health-sector perspective , the ICER for the CP relative to SC was USD18266 , 12100 and 40933 for Australia , the United Kingdom and Germany , respectively .
RESULTS	Corresponding societal ICER figures were USD31 ,663 , 24,996 and 51,571 .
CONCLUSIONS	The CP was a cost-effective approach from a health funder and societal perspective .
CONCLUSIONS	Despite participants in the CP group attending two to three times more meetings than the SC group , the CP was still cost effective even including these added patient travel costs .
CONCLUSIONS	This study indicates that it is cost effective for general practitioners ( GPs ) to refer overweight and obese patients to a CP , which may be better value than expending public funds on GP visits to manage this problem .

###19338552
OBJECTIVE	To analyse the efficiency of extracorporeal shockwave lithotripsy ( ESWL ) vs retrograde ureteroscopy and holmium : YAG laser lithotripsy , as ESWL is successful in 67-90 % of cases but endoscopic lithotripsy with pneumatic lithotrites or lasers is successful in 90-96 % of distal ureteric calculi , and holmium : YAG lithotripsy is effective in proximal ureteric calculi .
METHODS	From April 2006 to April 2008 we assessed 164 patients undergoing ureteric lithiasis in two homogeneous groups : group A included 83 treated with retrograde ureteroscopy and holmium : YAG endoscopic lithotripsy , and group B , 81 treated by ESWL .
METHODS	For laser lithotripsy we used 2071 mJ pulses at 3-6 Hz , with a mean of 1105 pulses and 2.5 kJ of total energy .
METHODS	ESWL was carried out using 37.5-87 .5 mJ shock waves , a mean of 3650 shock waves and 187.6 J , with a radioscopy time of 1-4 min .
METHODS	The results were assessed after 3 weeks with plain films and ultrasonography , or urography .
METHODS	The efficiency of each procedure was assessed by calculating the relative risk , and results compared using the chi-square or Student 's t-test .
METHODS	The efficiency quotient ( EQ ) was determined for both procedures , and the focal applied energy quotient ( FAEQ ) used to assess ESWL .
RESULTS	The overall success rate for retrograde ureteroscopy and laser lithotripsy was 96.4 % ( 80/83 patients ) , with an EQ of 0.52 ; a JJ catheter was placed in 67 patients .
RESULTS	The success rate for the first ESWL session was 48 % , and after repeat ESWL was 64 % ( 52/81 patients ) , giving an EQ of 0.39 .
RESULTS	For successful treatments the FAEQ was 9.22 , vs 6.47 for the failures ( P < 0.005 ) .
RESULTS	There was a significant difference ( P < 0.001 ) favouring laser lithotripsy , with an absolute benefit of 46 % ( 95 % confidence interval 33.8-57 .9 % ) , and number needed to treat of 2 ( 2-3 ) , but no significant differences for lumbar ureteric calculi .
CONCLUSIONS	Endoscopic lithotripsy with the holmium laser is more effective than ESWL , but for lumbar ureteric calculi ESWL is therapeutically recommended as it is less invasive .

###21252144
BACKGROUND	Genetic studies have identified 2 single-nucleotide polymorphisms ( SNPs ) at the LPA locus ( rs3798220 and rs10455872 ) that are strongly and independently related to lipoprotein ( a ) levels and to coronary disease risk , but their relevance for other atherothrombotic disease is uncertain .
RESULTS	These 2 LPA SNPs were examined together as an LPA genotype score for associations with vascular outcomes among participants in the Heart Protection Study .
RESULTS	The LPA score was examined first in 12 236 participants with prevalent vascular disease ( 9277 coronary disease cases , and 1326 ischemic stroke and 2011 peripheral vascular disease cases with no history of coronary disease ) and 3687 vascular disease-free controls and , subsequently , in 3251 participants who had incident major vascular events during follow-up ( 2106 coronary disease , 507 ischemic stroke , and 707 peripheral vascular disease events ) .
RESULTS	For prevalent disease , the LPA score was strongly associated with coronary disease ( odds ratio [ OR ] per variant allele , 1.19 ; 95 % CI , 1.08 to 1.30 ) and peripheral vascular disease ( OR , 1.18 ; 95 % CI , 1.04 to 1.34 ) but not with ischemic stroke ( OR , 1.03 ; 95 % CI , 0.89 to 1.20 ) .
RESULTS	Similarly , for incident disease , the LPA score was strongly associated with coronary disease ( hazard ratio [ HR ] , 1.19 ; 95 % CI , 1.09 to 1.30 ) and peripheral vascular disease ( HR , 1.20 ; 95 % CI , 1.02 to 1.40 ) but not with ischemic stroke ( HR , 0.83 ; 95 % CI , 0.67 to 1.03 ) .
CONCLUSIONS	The comparable strength of associations of the LPA score with coronary disease and peripheral vascular disease but not with stroke suggest that lipoprotein ( a ) may have effects on atherothrombotic vascular disease that are only relevant at specific sites .
CONCLUSIONS	Clinical Trial Registration - URL : http://isrctn.org .
CONCLUSIONS	Unique identifier : ISRCTN48489393 .

###19671263
BACKGROUND	This study was designed to compare differences in intraoperative blood loss , mean arterial blood pressure ( MABP ) , and duration of surgery when 0.25 % bupivacaine with 1:200000 epinephrine is injected , preoperatively , versus normal saline ( NS ) , during functional endoscopic sinus surgery ( FESS ) .
METHODS	A prospective , double-blind randomized placebo-controlled study was performed .
METHODS	Part I involved 46 patients who were infiltrated with 0.25 % bupivacaine with 1:200000 epinephrine on one side of the nose and sterile NS on the other ( control ) .
METHODS	Part II involved 30 patients infiltrated with 0.25 % bupivacaine with 1:200000 epinephrine bilaterally and 30 patients with NS bilaterally ( control ) .
METHODS	Patient demographics , preoperative MABP , intraoperative MABP , duration of surgery , and total estimated blood loss ( EBL ) were recorded for each side ( Part I ) and case ( Part II ) .
RESULTS	For part I , there were 46 patients ( mean age , 49 years ) , 24 women and 22 men .
RESULTS	MABP was 72 mmHg for each side ( p = 0.97 ) .
RESULTS	Preoperative MABP was 93 mmHg .
RESULTS	Duration of surgery was 48 minutes for epinephrine side and 45 minutes for control ( p = 0.17 ) .
RESULTS	Total EBL was 185 mL for the epinephrine side and 197 mL for control ( p = 0.53 ) .
RESULTS	For Part II , there were 60 patients ( mean age , 56 years ) , 28 women and 32 men .
RESULTS	The MABP was 77 mmHg for the epinephrine group and 72 mmHg for control ( p = 0.048 ) .
RESULTS	Preoperative MABP was 100 mmHg for the epinephrine group and 97 mmHg for control ( p = 0.37 ) .
RESULTS	Duration of surgery was 2.25 hours for the epinephrine group and 2.08 hours for control ( p = 0.17 ) .
RESULTS	Total EBL was 589 mL for the epinephrine group and 538 mL for control ( p = 0.64 ) .
CONCLUSIONS	There was no significant reduction in intraoperative blood loss during FESS when local anesthetic containing epinephrine was used compared with infiltration with NS .
CONCLUSIONS	More importantly , Part II shows a significantly higher MABP associated with infiltration of epinephrine .
CONCLUSIONS	Parts I and II did not show a significant difference in preoperative MABP or duration of surgery .

###21794155
BACKGROUND	Whiplash injury affects 83 % of persons in a traffic collision and leads to whiplash-associated disorders ( WAD ) .
BACKGROUND	A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence .
BACKGROUND	Our objective is to compare the cost-effectiveness of : 1 ) physician-based education and activation , 2 ) a rehabilitation program developed by Aviva Canada ( a group of property and casualty insurance providers ) , and 3 ) the legislated standard of care in the Canadian province of Ontario : the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario .
METHODS	The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial 's one-year follow-up .
METHODS	Resource use ( costs ) will include all health care goods and services , and benefits provided during the trial 's 1-year follow-up .
METHODS	The primary health effect will be the quality-adjusted life year .
METHODS	We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit .
METHODS	Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics , respectively .
METHODS	A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions .
METHODS	An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for , and inform priority setting in , research of WAD management .
CONCLUSIONS	Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management .
BACKGROUND	http://ClinicalTrials.gov identifier NCT00546806 [ Trial registry date : October 18 , 2007 ; Date first patient was randomized : February 27 , 2008 ] .

###21668768
OBJECTIVE	This study compares the maternal heart rate effects of carbetocin and oxytocin during elective caesarean delivery .
METHODS	Double blind randomised single centre study ( 1:1 ) .
METHODS	University hospital providing intrapartum care .
METHODS	Fifty-six women undergoing elective caesarean section after spinal anaesthesia .
METHODS	Haemodynamic parameters were measured non-invasively using the Task Force ( ) Monitor 3040i system .
METHODS	Measurements were taken for 500 seconds upon administration of a slow intravenous bolus of the clinically recommended doses of 100 g of carbetocin or 5 IU of oxytocin to prevent postpartum haemorrhage ( PPH ) .
METHODS	Effect on maternal heart rate ( HR ) .
RESULTS	Statistically indistinguishable haemodynamic effects were seen for both drugs , with a maximal effect at about 30-40 seconds : HR increased 17.98 2.53 bpm for oxytocin and 14.20 2.45 bpm for carbetocin .
RESULTS	Systolic blood pressure ( sBP ) decreased ( -26.80 2.82 mmHg for oxytocin versus -22.98 2.75 mmHg for carbetocin ) .
RESULTS	Following the maximal effect , women treated with carbetocin recovered slowly to baseline values asymptotically ( HR and BP ) , whereas women treated with oxytocin displayed a slight rebound bradycardia at 200 seconds ( -6.8 1.92 bpm ) .
RESULTS	Patients under both treatments showed a similar profile of side effects without any indication of unexpected adverse effects .
CONCLUSIONS	Both oxytocins have comparable haemodynamic effects and are uterotonic drugs with an acceptable safety profile for prophylactic use .
CONCLUSIONS	Minimal differences in the recovery phase beyond 70 seconds are in keeping with the fact that carbetocin has an extended half-life compared with oxytocin .

###17324764
OBJECTIVE	The study 's objective was to compare subfascial ligation at three different levels and partial exeresis of the short saphenous vein for persistence of a reflux route and patients ' subjective improvement of symptoms .
METHODS	A prospective randomized clinical trial was conducted .
METHODS	Eighty-four limbs with incompetent short saphenous veins were randomized for subfascial ligation at three different levels ( n = 44 ) or partial exeresis ( n = 40 ) .
METHODS	Duplex ultrasound was performed preoperatively and postoperatively .
METHODS	The short saphenous vein was mapped before surgery .
METHODS	The patients ' symptoms were documented before and after surgery .
METHODS	The Student t test and chi ( 2 ) test were used to calculate differences between the two treatment groups .
METHODS	Logistic regression analyses were performed to determine predictive values for the primary outcome measures : persisting reflux route and patients ' subjective improvement after surgery .
RESULTS	Patients ' characteristics and previous and additional surgical intervention were not significantly different between the two treatment groups ( chi ( 2 ) test ) .
RESULTS	Postoperative duplex sonography showed reflux in 64 limbs ( 76 % ) .
RESULTS	Improvement of symptoms was demonstrated in 57 cases ( 68 % ) .
RESULTS	There was no significant difference in the persistence of reflux or patients ' improvement of symptoms between the two treatment groups .
CONCLUSIONS	Our study showed poor technical results after subfascial ligation at three different levels or partial exeresis of the short saphenous vein .
CONCLUSIONS	No significant differences in the persistence of a reflux route and patients ' subjective improvement of symptoms between both treatments were demonstrated .
CONCLUSIONS	Routine postoperative monitoring with duplex ultrasound would facilitate the surgical techniques , and anatomic knowledge of all variations of the saphenopopliteal junction is needed .

###10335729
OBJECTIVE	The Liaison Committee on Medical Education mandates a core curriculum in primary care but does not specify its content or structure .
OBJECTIVE	In this study , we explored the question of whether primary care specialty or geographic location affects student learning and satisfaction .
METHODS	From 1994 to 1996 , 294 third-year medical students at one medical school in New York state were randomly assigned to multiple teaching sites for a required 5-week primary care clerkship .
METHODS	Independent predictor variables were primary care specialty of the preceptor ( family medicine , medicine , pediatrics , or joint medicine and pediatrics ) and geographic location of the site ( urban , suburban , rural ) .
METHODS	Outcome measures included four areas of student satisfaction , one of patient volume , and two of student performance .
RESULTS	Primary care specialty had no detectable association with the outcome measures , except for a lower rating of patient diversity in pediatric experiences ( P < 0.001 ) .
RESULTS	Geographic location of the site had a significant association with all measures of student satisfaction and patient volume ( all P values < 0.001 ) .
RESULTS	Students at rural sites rated the experience more highly and saw on average 15 more patients per rotation .
RESULTS	Ratings of student satisfaction remained high after adjusting for patient volume .
RESULTS	Primary care specialty and geographic location did not influence student performance in the clerkship or scores on standardized patient examination .
CONCLUSIONS	Rural geographic location of teaching site , but not primary care specialty , was associated with higher student satisfaction .
CONCLUSIONS	However , higher student satisfaction ratings did not correspond to better student performance .
CONCLUSIONS	Provided that all sites meet the screening criteria for inclusion in a teaching program , these findings support the continued development of high-quality , heterogeneous , interdisciplinary , primary care experiences .

###12734150
OBJECTIVE	To examine the effects of iv compound sodium lactate ( CSL ) with and without caloric supplementation with dextrose on nausea , vomiting and pain following general anesthesia for laparoscopy .
METHODS	We compared iv fluid loading with and without supplementary dextrose for the prevention of postoperative nausea and vomiting ( PONV ) .
METHODS	In a prospective double-blinded controlled trial , 120 ASA I female patients undergoing elective gynecological laparoscopy were randomized to one of three groups , and received either : ( a ) CSL 1.5 mL.kg ( -1 ) per hour fasting duration ; ( b ) CSL , 1.5 mL.kg ( -1 ) per hour fasting duration with 0.5 g.kg ( -1 ) dextrose added in 50 % formulation ( CSL/dextrose ) ; or ( c ) no iv fluid ( control ) .
RESULTS	Compared with control the percentage of patients who had no PONV within 24 hr of anesthesia in the CSL and CSL/dextrose groups was 78 % vs 83 % and 71 % , P = 0.81 and P = 0.683 respectively .
RESULTS	The numbers needed-to-harm for causing PONV episodes in CSL/dextrose vs CSL or control groups were 5.7 [ 95 % confidence interval ( CI ) , 5.57-5 .91 ] and 8.2 ( 95 % CI , 8.01-8 .37 ) respectively .
RESULTS	The number needed-to-treat for prevention of PONV episodes in CSL vs control was 19.2 ( 95 % CI , 19.08-19 .37 ) .
RESULTS	A greater proportion of patients in the CSL/dextrose group required narcotic analgesia in the postanesthetic care unit compared to those in the control group ( 16/35 vs 7/37 , P = 0.03 ) .
RESULTS	The CSL/dextrose group also demonstrated hyperglycemia ( serum glucose 14.0 + / - 3.94 vs 5.0 + / - 1.01 vs 5.2 + / - 0.9 mmol.L ( -1 ) , P < 0.0001 ) in the postanesthetic care unit compared to the CSL and control groups .
RESULTS	The CSL/dextrose group also reported increased thirst at 24 hr compared to control ( 20/35 vs 11/37 , P = 0.035 ) .
CONCLUSIONS	These findings suggest that : 1 ) administration of dextrose is associated with nausea , increased opioid requirement and late thirst after elective gynecological laparoscopy ; 2 ) iv fluids did not decrease PONV .

###23632396
OBJECTIVE	To investigate the effect of refractive correction on the reliability and accuracy of frequency-doubling technology ( FDT ) Matrix examinations .
METHODS	Forty-eight eyes of healthy people were submitted to the FDT Matrix 30/2 threshold program .
METHODS	They had experience in perimetry , normal eye examination , and negative history for glaucoma and/or neurological diseases .
METHODS	The subjects were randomized into groups A ( 24 subjects ) and B ( 24 subjects ) .
METHODS	The FDT Matrix 30/2 examinations were carried out in 3 different sessions .
METHODS	At the first session , groups A and B underwent the examinations with their best refractive correction .
METHODS	In the second session , group A underwent the FDT 30/2 examination with best refractive correction and the group B without it .
METHODS	In the third session , the groups were matched and followed the same protocol .
METHODS	The perimetric and reliability indexes and the time of examination with or without correction were considered .
METHODS	The Student t test was used when the distribution of the data was normal , whereas Mann-Whitney when the distribution of the data was not normal .
METHODS	After a Bonferroni correction , a P value < 0.001 was considered as statistically significant .
RESULTS	Mean deviation reduced statistically significantly when refractive correction was used ( -2.653.71 vs. -1.413.51 dB ; P < 0.006 ) .
RESULTS	All the other perimetric indexes and data considered did not change significantly when the subjects did the examination with or without the refractive correction .
CONCLUSIONS	The statistically significant reduction of mean deviation obtained with corrective lens showed that a better general accuracy and reliability of FDT responses was obtained with refractive correction .
CONCLUSIONS	Pattern standard deviation constancy with or without correction confirmed that a localized defect is the first sign of visual field defect and that the absence of differences of pattern standard deviation between the 2 sessions is related to the absence of pathologic conditions in the eyes studied .
CONCLUSIONS	Finally , as FDT Matrix is less influenced by other nonconventional perimetric techniques by refractive errors , the use of corrective lens is advisable to improve the accuracy and reliability of the results obtained and to optimize their performance .

###21901116
BACKGROUND	Due to the growing prevalence of type 2 diabetes , new dietary solutions are needed to help improve glucose and lipid metabolism in persons at high risk of developing the disease .
BACKGROUND	Herein we investigated the effects of low-insulin-response grain products , fatty fish , and berries on glucose metabolism and plasma lipidomic profiles in persons with impaired glucose metabolism .
RESULTS	Altogether 106 men and women with impaired glucose metabolism and with at least two other features of the metabolic syndrome were included in a 12-week parallel dietary intervention .
RESULTS	The participants were randomized into three diet intervention groups : ( 1 ) whole grain and low postprandial insulin response grain products , fatty fish three times a week , and bilberries three portions per day ( HealthyDiet group ) , ( 2 ) Whole grain enriched diet ( WGED ) group , which includes principally the same grain products as group ( 1 ) , but with no change in fish or berry consumption , and ( 3 ) refined wheat breads ( Control ) .
RESULTS	Oral glucose tolerance , plasma fatty acids and lipidomic profiles were measured before and after the intervention .
RESULTS	Self-reported compliance with the diets was good and the body weight remained constant .
RESULTS	Within the HealthyDiet group two hour glucose concentration and area-under-the-curve for glucose decreased and plasma proportion of ( n-3 ) long-chain PUFAs increased ( False Discovery Rate p-values < 0.05 ) .
RESULTS	Increases in eicosapentaenoic acid and docosahexaenoic acid associated curvilinearly with the improved insulin secretion and glucose disposal .
RESULTS	Among the 364 characterized lipids , 25 changed significantly in the HealthyDiet group , including multiple triglycerides incorporating the long chain ( n-3 ) PUFA .
CONCLUSIONS	The results suggest that the diet rich in whole grain and low insulin response grain products , bilberries , and fatty fish improve glucose metabolism and alter the lipidomic profile .
CONCLUSIONS	Therefore , such a diet may have a beneficial effect in the efforts to prevent type 2 diabetes in high risk persons .
BACKGROUND	ClinicalTrials.gov NCT00573781 .

###7696164
BACKGROUND	From 1980 to 1983 the Swiss Group for Clinical Cancer Research ( SAKK ) performed a randomised phase III trial in patients with small-cell lung cancer with the objective of improving the results of induction chemotherapy and defining the role of consolidating chest irradiation .
METHODS	Patients were initially randomised to induction arms AVP ( adriamycin , etoposide and cisplatin given every four weeks for four cycles ) , EVA ( cyclophosphamide , etoposide and adriamycin given every four weeks for four cycles ) or MOC/AVP ( methotrexate , vincristine , cyclophosphamide alternating with adriamycin , etoposide and cisplatin given for two cycles ) .
METHODS	All patients received prophylactic cranial irradiation with 30 Gy , and after four months of induction chemotherapy were randomized to maintenance chemotherapy with or without consolidating chest irradiation .
METHODS	The patients in the combined-modality maintenance arm first received radiation therapy to the chest ( 45 Gy ) followed by MOC/EVA chemotherapy .
RESULTS	266 patients were eligible and evaluable .
RESULTS	An overall response rate of 70 % with 21 % of complete remissions , a median survival of 9.3 months and survival of 8 % of the patients at two years were observed .
RESULTS	The highest objective response rate was achieved with the AVP-induction chemotherapy with an 80 % response rate and 32 % complete remissions .
RESULTS	Similar results were achieved with the alternating regimen of MOC/AVP .
RESULTS	In contrast , patients treated with the EVA induction regimen had significantly lower overall remission ( 56 % ) and complete remission rates ( 7 % ) .
RESULTS	The role of consolidating chest irradiation could not be clarified in limited-disease patients due to the small number of them who were randomised to the maintenance part of the study .
RESULTS	However , in patients with extensive disease in partial remission after induction treatment , combined maintenance therapy had a more significant adverse effect on survival than maintenance chemotherapy alone ( median survival in the maintenance phase of 148 days versus 239 days , p = 0.011 ) .
CONCLUSIONS	We conclude that the combination of adriamycin , etoposide and cisplatin is an active induction treatment .
CONCLUSIONS	Consolidating chest irradiation is contraindicated in patients with extensive disease in partial remission after induction when given in a sequential manner , as in our trial .

###17380562
BACKGROUND	It would be desirable to predict which patients are most likely to benefit from preoperative autologous blood donation .
BACKGROUND	This aim of this study was to develop a point scoring system for predicting the need for blood transfusion in liver surgery .
METHODS	The medical records of 480 consecutive patients who underwent hepatic resection were analysed .
METHODS	The data set was split randomly into a derivation set of two-thirds and a validation set of one-third .
METHODS	Univariable analysis was carried out to determine the association between clinicopathological factors and blood transfusion .
METHODS	Significant variables were entered into a multiple logistic regression model , and a transfusion risk score ( TRS ) was developed .
METHODS	The accuracy of the system was validated by calculating the area under the receiver-operator characteristic ( ROC ) curve .
RESULTS	Factors associated with blood transfusion in multivariable analysis included preoperative haemoglobin concentration below 12.5 g/dl , largest tumour more than 4 cm , need for exposure of the vena cava , need for an associated procedure , and cirrhosis .
RESULTS	Each variable was assigned one point , and the total score was compared with the transfusion status of each patient in the validation set .
RESULTS	The TRS accurately predicted the likelihood of blood transfusion .
RESULTS	In the validation set the area under the ROC curve was 0.89 .
CONCLUSIONS	Use of the TRS could lead to substantial saving by improving the cost-effectiveness of the autologous blood donation programme .

###17006874
BACKGROUND	Standard measurement scales used in anti-dementia trials may not capture symptomatic changes recognized by clinicians and caregivers .
BACKGROUND	We studied a symptom checklist , completed separately by caregivers and by clinicians , to identify patterns of change associated with donepezil treatment .
METHODS	In a multi-centre , 6-month , open-label study of 101 primary care patients , changes in a 19-symptom checklist were assessed in relation to changes in standardized scales of cognition , activities of daily living , behavior , and caregiver burden .
RESULTS	Three symptoms were reported in more than 80 % of patients by both clinicians and caregivers : problems in remembering , ( 97 % ) , temporal orientation ( 89 % ) , and repetitiveness ( 85 % ) .
RESULTS	Five others overlapped on each of the clinician and caregiver ` top ten ' , including cognitive activation , spatial orientation , leisure , attention , and apathy .
RESULTS	Clinicians reported that symptoms did not improve in 38 patients , whereas there was some improvement in 43 , and improvement in most symptoms in 20 .
RESULTS	Caregivers reported that symptoms did not improve in 55 patients , whereas 27 and 19 patients showed some and most symptoms improving respectively .
RESULTS	Patients with the greatest symptomatic improvement also improved most on the ADAS-Cog and the other standardized measures , whereas no improvement ( or decline ) in each standardized measure was observed in people whose symptoms worsened or did not improve .
CONCLUSIONS	A symptom checklist allowed clinically meaningful profiles to be identified , but revealed different estimates of response between clinicians and caregivers .
CONCLUSIONS	Both agreed that improved executive function was the most common response .
CONCLUSIONS	A symptom checklist can help translate between standard measures and everyday practice .

###9827783
BACKGROUND	Ardeparin sodium has recently received approval by the Food and Drug Administration for prophylaxis against venous thromboembolism in patients undergoing elective total knee replacement .
BACKGROUND	However , this low-molecular-weight heparin has not been previously evaluated in a randomized controlled trial for treatment of established acute deep venous thrombosis .
METHODS	The study included patients with ultrasound-documented acute symptomatic deep venous thrombosis of the legs .
METHODS	They had to be deemed appropriate for discharge home to receive subcutaneous low-molecular-weight heparin .
METHODS	Patients were randomized to receive ardeparin with a 2-day hospitalization or unfractionated heparin sodium with a 5-day hospitalization .
METHODS	Both groups received warfarin sodium .
METHODS	Follow-up ultrasound examinations were undertaken at 6 weeks .
RESULTS	Of the 80 patients enrolled , 75 had follow-up ultrasonography .
RESULTS	Evaluation of baseline vs 6-week venous scans demonstrated that , overall , 31 of the 39 ardeparin-treated patients improved , compared with 21 of the 36 patients assigned to receive unfractionated heparin ( P = .05 ) .
RESULTS	The 95 % confidence interval for the difference in improvement was 0.6 % to 42 % in favor of ardeparin .
RESULTS	Median charges for ardeparin and unfractionated heparin were $ 2815 and $ 6500 , respectively ( P < .001 ) .
RESULTS	There were no differences in bleeding or patient satisfaction between the 2 groups .
CONCLUSIONS	The results of this small preliminary trial suggest that ardeparin can be administered effectively and safely to selected patients with acute deep venous thrombosis and that , with proper nursing and home services , it can help decrease the duration of hospitalization .

###22256638
OBJECTIVE	To compare the clinical efficacy between Ashi-points and anti-Ashi-points for external humeral epicondylitis .
METHODS	Sixty-eight cases were randomly devided into an anti-Ashi-points group ( group A ) and an Ashi-points group ( group B ) , 34 cases in each group .
METHODS	In the group A , anti-Ashi-points ( points of pain relief or disappearance after local press ) were selected for acupuncture ; in the group B , Ashi-points ( pain spots ) were selected for acupuncture and surrounded needling therapy was added .
METHODS	Once other day , 10 treatments made one session , altogether 2 courses .
METHODS	The clinical effects were observed at the ending day , the 7th day , the 30th day , the 6th months and one year after treatment .
RESULTS	The effective rates at the ending day , the 7th day , the 30th day after treatment in the group A were 100.0 % ( 34/34 ) , 94.1 % ( 32/34 ) and 91.2 % ( 31/34 ) , which were superior to those of 73.5 % ( 25/34 ) , 70.6 % ( 24/34 ) , 67.6 % ( 23/34 ) respectively in group B ( all P < 0.01 ) .
RESULTS	In the group A , the effective rates at the 6 th months and one year after treatment were 73.5 % ( 25/34 ) and 52.9 % ( 18/34 ) ; in group B , they were 64.7 % ( 22/34 ) and 61.8 % ( 21/34 ) respectively , there were no significant differences between the two groups ( both P > 0.05 ) .
CONCLUSIONS	The acupoint selection of anti-Ashi-points has a better transient effect on external humeral epicondylitis , but it 's long-term curative effects is similar to Ashi-points .

###23269401
OBJECTIVE	To analyse the effects of lightweight meshes in laparoscopic inguinal hernia repair on male fertility aspects , chronic pain development and recurrence at 3-year follow-up .
METHODS	Fifty-nine male patients with a primary , unilateral or bilateral inguinal hernia were randomised to laparoscopic inguinal hernia repair using a standard polypropylene ( Marlex ( ) ) or lightweight mesh ( VyproII ( ) , TiMesh ( ) ) .
METHODS	Patients attended clinical follow-up 3 years postoperatively , at which male fertility aspects , by semen analysis and scrotal ultrasound , chronic pain status ( McGill Pain Questionnaire ) , quality of life ( SF-36 ) and recurrence were assessed , or completed quality of life , pain and hernia-specific questionnaires at home .
RESULTS	In total , 49 patients ( 83.1 % ) completed follow-up ( median follow-up = 39.1 months ) , by questionnaire and/or clinical follow-up .
RESULTS	As other semen parameters and scrotal ultrasound results , sperm motility was unchanged compared to 1 year postoperatively , but not significantly different between VyproII ( ) and TiMesh ( ) versus Marlex ( ) patients ( -8.5 % and -8 % vs. -2.8 % ; P = 0.23 ) .
RESULTS	Pain perception and quality of life were comparable between the heavyweight and lightweight groups , and no change was noted in comparison with 1 year postoperatively .
RESULTS	Chronic pain incidence was 6.1 % ( 3 patients ) , without occurrence of disabling pain .
RESULTS	Three patients were clinically diagnosed with a recurrent hernia ( 5.9 % ) .
CONCLUSIONS	The decrease in sperm motility in patients operated on with a lightweight mesh compared to patients operated on with a heavyweight mesh 1 year after laparoscopic inguinal hernia repair could not be confirmed at 3 years follow-up .
CONCLUSIONS	Furthermore , heavyweight and lightweight groups were comparable regarding quality of life , chronic pain and recurrence rate .

###12161042
OBJECTIVE	To investigate the effectiveness and safety of a red clover isoflavone dietary supplement ( Promensil , Novogen Ltd. , Australia ) versus placebo on the change in hot flush frequency in postmenopausal women .
METHODS	In this randomized , double blind , placebo-controlled trial 30 women with more than 12 months amenorrhoea and experiencing more than five flushes per day were enrolled .
METHODS	All received single blind placebo tablets for 4 weeks and were subsequently randomized to either placebo or 80 mg isoflavones for a further 12 weeks .
METHODS	Efficacy was measured by the decrease in number of hot flushes per day and changes in Greene Climacteric Scale Score .
RESULTS	During the first 4 weeks of placebo the frequency of hot flushes decreased by 16 % .
RESULTS	During the subsequent double blind phase , a further , statistically significant decrease of 44 % was seen in isoflavones group ( P < 0.01 ) , whereas no further reduction occurred within the placebo group .
RESULTS	The Greene score decreased in the active group by 13 % and remained unchanged in the placebo group .
CONCLUSIONS	In this study , treatment with 80 mg isoflavones ( Promensil ) per day resulted in a significant reduction in hot flushes from baseline .
CONCLUSIONS	At the end of the study there was a significant decrease in hot flushes of 44 % between the active and placebo group , demonstrating the effectiveness of Promensil in the management of hot flushes .

###15037402
OBJECTIVE	To evaluate the effect of adjuvant low-dose aspirin on utero-ovarian blood flow and ovarian responsiveness in poor responders undergoing IVF .
METHODS	Prospective randomized , double-blind , placebo-controlled study .
METHODS	University-affiliated teaching hospital .
METHODS	Sixty patients classified as poor responders undergoing IVF .
METHODS	Supplementation with low-dose aspirin ( 80 mg daily ) or placebo to a long down-regulation protocol .
METHODS	Doppler measurement of intraovarian and uterine pulsatility index was performed before ( baseline ) and after ovarian stimulation ( day of hCG administration ) .
METHODS	Duration of use and dose of gonadotropins , cycle cancellation rate , number of mature follicles recruited , and oocytes retrieved were also measured .
RESULTS	High cancellation rates were found in both groups ( 33.3 % vs. 26.7 % , placebo vs. treatment ) .
RESULTS	There were no significant differences in total dose of hMG used ( 66 vs. 57 hMG , 75 IU ampules ) , median number of mature follicles recruited ( 3.5 vs. 3.0 ) , or median number of oocytes retrieved ( 4 vs. 3 ) .
RESULTS	No significant differences were found in either intraovarian or uterine artery pulsatility index measured at baseline or on the day of hCG administration .
CONCLUSIONS	Supplementation with low-dose aspirin failed to improve either ovarian and uterine blood flow or ovarian responsiveness in poor responders undergoing IVF .

###21123471
OBJECTIVE	Evidence of the effects of tight , prolonged binding of infants on development is inconclusive and based on small ethnographic studies .
OBJECTIVE	The null hypothesis was that Mongolian infants not swaddled or swaddled tightly in a traditional setting ( to > 7 months of age ) do not have significantly different scores for the Bayley Scales of Infant Development , Second Edition ( BSID-II ) .
METHODS	In a randomized controlled trial , 1279 healthy newborns in Ulaanbaatar , Mongolia , were allocated at birth to traditional swaddling or nonswaddling .
METHODS	The families received 7 months of home visits to collect data and monitor compliance .
METHODS	At 11 to 17 months of age , the BSID-II was administered to 1100 children .
RESULTS	No significant between-group differences were found in mean scaled mental and psychomotor developmental scores .
RESULTS	The unadjusted mean difference between the groups was -0.69 ( 95 % confidence interval [ CI ] : -2.59 to 1.19 ) for psychomotor and -0.42 ( 95 % CI : -1.68 to 0.84 ) for mental scores in favor of the swaddling group .
RESULTS	A subgroup analysis of the compliant sample produced similar results .
RESULTS	BSID-II-scaled psychomotor and mental scores were 99.98 ( 95 % CI : 99.03-100 .92 ) and 105.52 ( 95 % CI : 104.89-106 .14 ) , respectively .
RESULTS	Background characteristics were balanced across the groups .
CONCLUSIONS	In the Mongolian context , prolonged swaddling in the first year of life did not have any significant impact on children 's early mental or psychomotor development .
CONCLUSIONS	Additional studies in other settings need to confirm this finding .
CONCLUSIONS	The Mongolian infants in this trial had scaled BSID-II mental and psychomotor scores comparable to United States norms .

###8093705
BACKGROUND	Salmeterol is a new inhaled selective beta 2-adrenergic receptor agonist with a long duration of action .
BACKGROUND	We studied the duration of the bronchodilation and the protective effect against methacholine-induced airway obstruction of a single dose of salmeterol in a double-blind , randomized , placebo-controlled , crossover design .
METHODS	Seventeen boys and three girls with mild-to-moderate asthma participated in the study .
METHODS	On two separate days either 50 micrograms salmeterol or placebo was inhaled .
METHODS	FEV1 and PD20 methacholine were determined before and 1 , 4 , 8 , 12 , and 24 hours after inhalation .
RESULTS	Salmeterol resulted in a significant bronchodilation compared with placebo , up to 12 hours ( p = 0.0001 ) .
RESULTS	At 24 hours there was a residual effect that approached significance ; mean FEV1 being 8.3 % + / - 2.4 % above baseline ( p = 0.06 ) .
RESULTS	Significant protection against airway sensitivity to methacholine after salmeterol inhalation was found at all time points ( p < 0.005 ) .
RESULTS	Twenty-four hours after administration mean PD20 was still 1.22 + / - 0.29 doubling dose above baseline .
RESULTS	No important adverse effects were noted .
CONCLUSIONS	We conclude that a single dose of 50 micrograms salmeterol in children with asthma gives a long-lasting bronchodilation , exceeding 12 hours , which is comparable to the results in adult studies .
CONCLUSIONS	The duration of the protection against airway sensitivity to methacholine exceeds 24 hours .

###22532639
OBJECTIVE	The aim was to compare continuous and on-demand NSAID treatment with respect to their ability to suppress radiographic progression in subgroups of patients with high/elevated CRP-levels , ESR , ASDAS-levels or BASDAI-levels in comparison to patients with normal levels .
METHODS	Post-hoc analyses were performed in a randomized trial comparing continuous and on-demand NSAID treatment .
METHODS	Relevant high/elevated subgroups were created based on time-averaged ( ta ) CRP ( > 5mg/L ) , ta-ESR ( > 12mm/hr ) , ta-BASDAI ( > 4 ) , ta-ASDAS-CRP ( > 2.1 ) and ta-ASDAS-ESR ( > 2.1 ) .
METHODS	Subgroups were further split according to NSAID-use ( continuous vs. on-demand ) .
METHODS	Radiological progression was presented in probability plots .
METHODS	Statistical interactions were tested using multiple and logistic regression analysis .
METHODS	Differences in radiological progression were analysed using the Chi-square and Mann-Whitney U test .
RESULTS	150 participants randomized to either the continuous-treatment group ( n = 76 ) , or the on-demand group ( n = 74 ) had complete radiographs and were included .
RESULTS	The effect of slowing radiological progression with continuous NSAID therapy was more pronounced in patients with elevated ta-CRP-levels , elevated ta-ESR , high ta-ASDAS-CRP or high ta-ASDAS-ESR versus patients with low/normal values .
RESULTS	No such effect was found for participants with high vs. low BASDAI .
RESULTS	Also , in participants with elevated ta-ESR ( irrespective of treatment ) , there appeared to be a higher rate of structural progression than in participants with normal ta-ESR .
RESULTS	Regression analyses showed that continuous NSAID treatment neutralizes the negative effect of inflammation ( high ta-ESR ) .
CONCLUSIONS	Patients with elevated acute phase reactants seem to benefit most from continuous treatment with NSAIDs .
CONCLUSIONS	Continuous NSAID-therapy in patients with elevated acute phase reactants may lead to an improved benefit-risk-ratio of these drugs .

###19938933
OBJECTIVE	To examine whether the decrease in the mean breath alcohol concentration ( BrAC ) and the rowdy social atmosphere reported after one month remained stable in the five-month assessment .
METHODS	Randomized controlled trial .
METHODS	University bars .
METHODS	The five-month assessment was based on 596 students visiting student bars during ordinary pub evenings .
METHODS	Bartenders ( n = 40 ) in 6 of 12 bars on a university campus underwent training programs in a randomized pattern .
METHODS	Bartenders in control bars did not participate in the program .
METHODS	The BrAC and reported social atmosphere in a five-month follow-up assessment .
RESULTS	All measurements ( BrAC , rowdy , cozy , and high social atmosphere ) showed that time had a significant decreasing effect .
RESULTS	The positive effects on BrAC and rowdy atmosphere shown in the one-month follow-up were no longer evident after five months .
CONCLUSIONS	The positive results after one month were not stable after five months .
CONCLUSIONS	The study 's limitations are noted .

###17340064
BACKGROUND	Endothelial dysfunction , detectable by an impaired flow-mediated vasodilation ( FMD ) of the brachial artery , has been shown to be associated with increased levels of circulating proinflammatory markers .
BACKGROUND	Therapeutic interventions such as lipid-lowering with statins increase FMD and decrease inflammatory markers , like soluble ( s ) E-selectin , soluble intercellular adhesion molecule-1 ( sICAM-1 ) or high-sensitivity Creactive protein ( hsCRP ) .
BACKGROUND	The effect of atorvastatin therapy on both FMD and inflammatory markers in patients with stable coronary artery disease ( CAD ) has not been investigated .
METHODS	Thirty hypercholesterolemic patients with angiographically documented stable coronary artery disease ( CAD ) were randomized to placebo or atorvastatin ( 20 mg/d ) for 3 months .
METHODS	FMD was assessed using highresolution ultrasound ( 13 MHz , Acuson Sequoia , C256 ) .
METHODS	High-sensitivity CRP was measured with Latex agglutination assay , sE-selectin and sICAM-1 were determined with ELISA .
RESULTS	Baseline characteristics were not different between groups .
RESULTS	FMD improved in patients on atorvastatin ( 6.7 + / -3.8 % to 8.5 + / -4.4 % ; p < 0.01 ) , but remained unchanged in placebo-treated patients ( 8.2 + / -3.3 % to 8.9 + / -5.1 % ; p = NS ) .
RESULTS	Atorvastatin treatment was associated with decreases of sICAM-1 ( from 274.2 + / -92.2 to 197.9 + / -70.0 ng/ml ; p < 0.01 ) and hsCRP ( from 0.57 + / -0.45 to 0.18 + / -0.15 mg/dl ; p < 0.01 ) , whereas placebo treatment had no effect on these markers .
RESULTS	sE-selectin levels were not influenced by either treatment .
RESULTS	No correlations were found between changes in FMD , lipids and inflammatory markers .
CONCLUSIONS	Treatment with atorvastatin leads to an improvement in endothelial function and a reduction in inflammatory markers in patients with stable CAD .
CONCLUSIONS	The lack of correlation between changes in FMD and inflammatory markers may support the concept of pleiotropic effects of statins in humans .

###21209304
OBJECTIVE	Recovery-oriented care for patients with schizophrenia involves consideration of cultural issues , such as religion and spirituality .
OBJECTIVE	However , there is evidence that psychiatrists rarely address such topics .
OBJECTIVE	This study examined acceptance of a spiritual assessment by patients and clinicians , suggestions for treatment that arose from the assessment , and patient outcomes -- in terms of treatment compliance and satisfaction with care ( as measured by treatment alliance ) .
METHODS	Outpatients with psychosis were randomly assigned to two groups : an intervention group that received traditional treatment and a religious and spiritual assessment ( N = 40 ) and a control group that received only traditional treatment ( N = 38 ) .
METHODS	Eight psychiatrists were trained to administer the assessment to their established and stable patients .
METHODS	After each administration , the psychiatrist attended a supervision session with a psychiatrist and a psychologist of religion .
METHODS	Baseline and three-month data were collected .
RESULTS	The spiritual assessment was well accepted by patients .
RESULTS	During supervision , psychiatrists reported potential clinical uses for the assessment information for 67 % of patients .
RESULTS	No between-group differences in medication adherence and satisfaction with care were found at three months , although patients in the intervention group had significantly better appointment attendance during the follow-up period .
RESULTS	Their interest in discussing religion and spirituality with their psychiatrists remained high .
RESULTS	The process was not as well accepted by psychiatrists .
CONCLUSIONS	Spiritual assessment can raise important clinical issues in the treatment of patients with chronic schizophrenia .
CONCLUSIONS	Cultural factors , such as religion and spirituality , should be considered early in clinical training , because many clinicians are not at ease addressing such topics with patients .

###12577332
OBJECTIVE	To observe the effects of combined transdermal acupoint electric stimulation and isoflurane anesthesia on isoflurane-induced hypotension and tissue oxygen metabolism in patients undergoing craniotomy .
METHODS	Forty-two patients with brain tumor of ASA physical status I or II and scheduled for elective surgery were randomly divided into two groups .
METHODS	The craniotomy was undergoing in Group A with isoflurane anesthesia , while in Group B , with combined transdermal acupoint electric stimulation ( TAES ) and isoflurane anesthesia .
METHODS	Isoflurane induced hypotension was performed in both groups by augmenting the concentration of isoflurane to lower the mean arterial pressure than before anesthesia for 30 % -40 % and maintain for 30-45 mins .
METHODS	The tissue oxygen metabolism , blood gas and arterial lactic acid level before , during and after hypotension were monitored by Swan-Ganz floating catheterization .
RESULTS	As compared with before hypotension , the pulmonary arterial and mixed with venous blood oxygen saturation lowered and oxygen supply lowered , and oxygen uptake increased significantly in both groups ( P < 0.05 ) , but the extent of changes in oxygen metabolic criteria in Group B were all lesser than those in Group A ( P < 0.05 ) .
CONCLUSIONS	Combined acupoint electric stimulation and general anesthesia could maintain the tissue oxygen supply and demand balance better in the isofluraneinduced hypotension process .

###25348459
BACKGROUND	In rural South Africa , only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ` prevention of mother-to-child transmission ' ( PMTCT ) services in 2010 .
BACKGROUND	Studies generally support male involvement to promote PMTCT , but the nature and impact of that involvement is unclear and untested .
BACKGROUND	Additionally , stigma , disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care , suggesting that male involvement may be ` necessary , but not sufficient ' to reduce infant HIV incidence .
BACKGROUND	This study expands on a successful United States President 's Emergency Plan for AIDS Relief ( PEPFAR ) - supported PMTCT couples intervention pilot study conducted in the Mpumalanga province , targeting HIV-positive pregnant women and their partners , the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence .
METHODS	The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 randomly assigned Community Health Centers ( CHC ) ( six experimental , six control ) .
METHODS	The two cohorts will consist of women attending without their male partners ( n = 720 ) and women attending with their male partners ( n = 720 couples ) , in order to determine whether the influence of male participation itself , or combined with a behavioral PMTCT intervention , can significantly reduce infant HIV infection ante - , peri - and postnatally .
CONCLUSIONS	It is our intention to significantly increase PMTCT participation from current levels ( 69 % ) in the Mpumalanga province to between 90 and 95 % through engaging women and couples in a controlled , six session ante - and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT ( such as stigma , disclosure , intimate partner violence , communication , infant feeding practices and safer conception ) that prevent women and men from utilizing treatment opportunities available to them and their infants .
CONCLUSIONS	Based upon the encouraging preliminary results from our pilot study , successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa : HIV-positive pregnant women and their infants .
BACKGROUND	ClinicalTrials.gov NCT02085356 ( registration date : 10 March 2014 ) .

###24138011
OBJECTIVE	The purpose of this study was to evaluate the impact of prior antipsychotic exposure ( PAE ) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment .
METHODS	This study was a post-hoc analysis of pooled data from two 8-week , double-blind , randomized , placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder , aged 6-17 years .
METHODS	Subjects were stratified by PAE ; adverse events ( AEs ) , and changes in weight , and metabolic measures were evaluated .
METHODS	For subjects receiving aripiprazole , regardless of PAE , baseline weight , age , gender , and symptom severity were evaluated in a regression model predicting body weight change .
RESULTS	Of 316 randomized subjects , 259 ( 82.0 % ) were antipsychotic nave ( AN ) and 57 ( 18.0 % ) had a PAE .
RESULTS	Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence ( 11.9 % vs. 2.8 % ) , sedation ( 22.7 % vs. 11.1 % ) , or fatigue ( 17.0 % vs. 13.9 % ) .
RESULTS	Rates of extrapyramidal disorder and drooling , but not akathisia or tremor , were marginally higher in AN subjects .
RESULTS	Overall , 10.8 % of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3 % of aripiprazole-treated PAE subjects .
RESULTS	AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo ( 1.9 vs. 0.7 kg ; treatment difference 1.2 kg , 95 % CI : 0.5 , 1.9 ) than PAE subjects receiving aripiprazole compared with subjects receiving placebo ( 0.4 vs. -0.4 kg ; treatment difference 0.9 kg , 95 % CI : -0.6 , 2.4 ) .
RESULTS	Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain .
RESULTS	There were no significant changes in metabolic measures compared with placebo in either group .
CONCLUSIONS	Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score .
CONCLUSIONS	AN subjects were more likely to experience AEs related to somnolence .
CONCLUSIONS	However , based on discontinuations rates from AEs , overall tolerability was good for both AN and PAE groups .
BACKGROUND	Study of aripiprazole in the treatment of children and adolescents with autistic disorder .
BACKGROUND	Registry : www.clinicaltrials.gov .
BACKGROUND	Identifiers : NCT00332241 and NCT00337571 .

###23931247
OBJECTIVE	In this study , our aim was to evaluate the effects of intravenous dexketoprofen trometamol with ilioinguinal and iliohypogastric nerve block on analgesic quality and morphine consumption after total abdominal hysterectomy operations .
METHODS	We conducted this randomized controlled clinical study on 61 patients .
METHODS	The study was conducted in the operation room , post-anesthesia care unit , and inpatient clinic .
METHODS	We randomly grouped the 61 patients into control group ( group C ) , block group ( group B ) and dexketoprofen-block group ( group DB ) .
METHODS	Before the skin incision performed after anesthesia induction , we performed ilioinguinal iliohypogastric block ( group C given saline and group P and DB given levobupivacaine ) .
METHODS	In contrast to group C and B , group DB was given dexketoprofen .
METHODS	We administered morphine analgesia to all patients by patient-controlled analgesia ( PCA ) during the postoperative 24 hours .
METHODS	We recorded Visual Analogue Scale ( VAS ) , satisfaction scores , morphine consumption and side effects during postoperative 24 hours .
RESULTS	We found the DB groups VAS scores to be lower than the control group and block groups ( p < 0.05 ) values at postoperative 1st , 2nd , 6th and 12th hours .
RESULTS	VAS scores of group C were higher than of group B at postoperative fi rst 2 hours .
RESULTS	Time to fi rst PCA demand was longer , morphine consumption values were lower and satisfaction scores were higher in group DB than in the other two groups ( p < 0.05 ) .
CONCLUSIONS	Ilioinguinal-iliohypogastric nerve block with IV dexketoprofen increases patient satisfaction by decreasing opioid consumption , increasing patient satisfaction , which suggests that dexketoprofen trometamol is an effective non-steroidal anti-inflammatory analgesic in postoperative analgesia .

###24890124
OBJECTIVE	Transbronchial lung biopsy ( TBLB ) is required for evaluation in selected patients with interstitial lung disease ( ILD ) .
OBJECTIVE	The diagnostic yield of histopathologic assessment is variable and is influenced by factors such as the size of samples and the presence of crush artefacts left by conventional biopsy forceps .
OBJECTIVE	We compared the diagnostic yield and safety of TBLB with cryoprobe sampling versus conventional forceps sampling .
METHODS	This randomized clinical trial analysed data for 77 patients undergoing TBLB for evaluation of ILD ; patients were assigned to either a conventional-forceps group or a cryoprobe group .
METHODS	Two pathologists assessed the tissue samples and agreed on histopathologic diagnoses .
METHODS	We also compared the duration of procedures , complications and sample-quality variables .
RESULTS	The most frequent diagnosis observed in the cryoprobe group was non-specific interstitial pneumonia .
RESULTS	Histopathologic diagnoses were identified in more cases in the cryoprobe group ( 74.4 % ) than in the conventional-forceps group ( 34.1 % ) ( P < 0.001 ) , and the diagnostic yield was higher in the cryoprobe group ( 51.3 % vs 29.1 % in the conventional forceps group ; P = 0.038 ) .
RESULTS	A larger mean area of tissue was harvested by cryoprobe ( 14.7 11 mm ( 2 ) ) than by conventional forceps ( 3.3 4.1 mm ( 2 ) ) ( P < 0.001 ) .
RESULTS	More grade 2 bleeding ( not statistically significant ) occurred in the cryoprobe group ( 56.4 % ) than in the conventional-forceps group ( 34.2 % ) .
RESULTS	No differences in other complications were observed .
CONCLUSIONS	TBLB by cryoprobe is safe and potentially useful in the diagnosis of ILD .
CONCLUSIONS	Larger multisite randomized trials are required to confirm the potential benefits of this procedure .
CONCLUSIONS	Clinical trial registration at ClinicalTrials.gov : NCT01064609 .

###14578238
OBJECTIVE	This study evaluated the Diabetes Outpatient Intensive Treatment ( DOIT ) program , a multiday group education and skills training experience combined with daily medical management , followed by case management over 6 months .
OBJECTIVE	Using a randomized control design , the study explored how DOIT affected glycemic control and self-care behaviors over a short term .
OBJECTIVE	The impact of two additional factors on clinical outcomes were also examined ( frequency of case management contacts and whether or not insulin was started during the program ) .
METHODS	Patients with type 1 and type 2 diabetes in poor glycemic control ( A1c > 8.5 % ) were randomly assigned to DOIT or a second condition , entitled EDUPOST , which was standard diabetes care with the addition of quarterly educational mailings .
METHODS	A total of 167 patients ( 78 EDUPOST , 89 DOIT ) completed all baseline measures , including A1c and a questionnaire assessing diabetes-related self-care behaviors .
METHODS	At 6 months , 117 patients ( 52 EDUPOST , 65 DOIT ) returned to complete a follow-up A1c and the identical self-care questionnaire .
RESULTS	At follow-up , DOIT evidenced a significantly greater drop in A1c than EDUPOST .
RESULTS	DOIT patients also reported significantly more frequent blood glucose monitoring and greater attention to carbohydrate and fat contents ( ACFC ) of food compared with EDUPOST patients .
RESULTS	An increase in ACFC over the 6-month period was associated with improved glycemic control among DOIT patients .
RESULTS	Also , the frequency of nurse case manager follow-up contacts was positively linked to better A1c outcomes .
RESULTS	The addition of insulin did not appear to be a significant contributor to glycemic change .
CONCLUSIONS	DOIT appears to be effective in promoting better diabetes care and positively influencing glycemia and diabetes-related self-care behaviors .
CONCLUSIONS	However , it demands significant time , commitment , and careful coordination with many health care professionals .
CONCLUSIONS	The role of the nurse case manager in providing ongoing follow-up contact seems important .

###17785361
BACKGROUND	GH replacement in GH-deficient adults results in an improvement in metabolic status .
BACKGROUND	GH might also decrease visceral adiposity in obese adults that are not GH deficient .
OBJECTIVE	Our objective was to determine the effects of supraphysiological GH therapy on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-I and the durability of these effects after stopping GH therapy .
METHODS	The study was a double-blind , placebo-controlled 6-month intervention trial followed by a blinded follow-up period of 6 months .
METHODS	Thirty nondiabetic middle-aged men with central adiposity ( body mass index > 27 kg/m ( 2 ) ; waist circumference > 102 cm ) participated .
RESULTS	After 6 months of GH therapy , we observed an increase in weight and lean body mass ( 2.5 + / - 0.6 kg , P < 0.05 compared with baseline and placebo ) and 8.8 % reduction in visceral adiposity .
RESULTS	GH increased resting energy expenditure by 172.5 + / - 41.6 kcal/24 h after 6 months of therapy .
RESULTS	Fasting insulin , glucose , and the quantitative insulin sensitivity check index for insulin resistance increased during GH therapy .
RESULTS	The effects of GH on fatness and visceral adiposity disappeared shortly after GH withdrawal , but weight remained increased over baseline and when compared with the placebo group ( P < 0.05 ) .
CONCLUSIONS	These data suggest that GH therapy is associated with small but statistically significant decreases in visceral adiposity and an increase in lean mass and body weight .
CONCLUSIONS	In viscerally obese subjects , supraphysiological GH administration is not an effective treatment ; however , additional studies are needed to evaluate the effects of low-dose , physiological GH treatment .

###8814852
OBJECTIVE	To investigate the possible relationship between serum levels of prostate specific antigen ( PSA ) , dihydrotestosterone ( DHT ) , testosterone , sexual-hormone binding globulin ( SHBG ) and tumour stage , grade and ploidy in 65 cases of prostate cancer diagnosed in a screening study compared to 130 controls from the same population .
METHODS	From a population of 26,602 men between the ages of 55 and 70 years , 2400 were selected randomly and invited to undergo screening for prostate cancer using a digital rectal examination , transrectal ultrasonography and PSA analysis .
METHODS	Among the 1782 attendees , 65 cases of prostate cancer were diagnosed .
METHODS	Each case was matched with two control subjects of similar age and prostate volume from the screening population .
METHODS	Frozen serum samples were analysed for PSA , DHT , testosterone and SHBG , and compared to the diagnosis and tumour stage , grade and ploidy .
METHODS	Comparisons between these variables , and multivariate and regression analyses were performed .
RESULTS	There were significant differences in PSA level with all variables except tumour ploidy .
RESULTS	DHT levels were slightly lower in patients with prostate cancer but the difference was not statistically significant .
RESULTS	There was a trend towards lower DHT values in more advanced tumours and the difference for T-stages was close to statistical significance ( P = 0.059 ) .
RESULTS	Testosterone levels were lower in patients with cancer than in the control group , but the differences were not significant .
RESULTS	There was no correlation between testosterone levels , tumour stage and ploidy , but the differences in testosterone level in tumours of a low grade of differentiation compared to those with intermediate and high grade was nearly significant ( P = 0.058 ) .
RESULTS	The testosterone/DHT ratio tended to be higher in patients with more advanced tumours .
RESULTS	SHBG levels were lower in patients with cancer than in controls but the differences were not statistically significant .
RESULTS	There were no systematic variations of tumour stage , grade and ploidy .
RESULTS	Multivariate analysis showed that if the PSA level was known , then DHT , testosterone or SHBG added no further information concerning diagnosis , stage , grade or ploidy .
RESULTS	Regression analysis on T-stage , PSA level and DHT showed an inverse linear relationship between PSA and DHT for stage T-3 ( P = 0.035 ) , but there was no relationship between PSA and testosterone .
CONCLUSIONS	PSA was of value in discriminating between cases and controls and between various tumour stages and grades , but no statistically significant correlation was found for ploidy .
CONCLUSIONS	If PSA level was known , no other variable added information in individual cases .
CONCLUSIONS	Within a group , DHT levels tended to be lower among cases and in those with more advanced tumours .
CONCLUSIONS	There was an inverse relationship between tumour volume , as defined by PSA level , and 5 alpha-reductase activity , as defined by DHT level , and the testosterone/DHT ratio .
CONCLUSIONS	This trend was most obvious with T-stage .
CONCLUSIONS	No systematic variation were found in the levels of testosterone or SHBG .

###18613283
OBJECTIVE	To assess the efficacy of a harm-reduction based intervention to enhance access to treatment and clinical outcomes among elderly at-risk drinkers .
METHODS	A site-specific secondary data analysis of Primary Care Research in Substance Abuse and Mental Health for Elders study ( PRISM-E ) .
METHODS	Thirty-four at-risk drinkers age 65 or older who were randomized into one of two treatment conditions : an integrated care condition which incorporated a harm-reduction based approach to treatment and an enhanced referral condition .
METHODS	Access to subsequent services and clinical outcomes were examined 6 months post index-interview date .
METHODS	Clinical outcomes included changes in the number of drinks in the week prior to assessment , changes in the number of binges in the past 3 months prior to assessment , and changes in scores on the Short Michigan Alcoholism Screening Test-Geriatric Version ( SMAST-G ) .
RESULTS	At-risk drinkers in the integrated care condition were more likely to access treatment than at-risk drinkers assigned to the enhanced referral condition ( 93 % vs 35 % ; chi ( 2 ) = 11.38 , df = 1 , p = 0.001 ) .
RESULTS	Among those who received treatment , there were no differences in the total amount of treatment visits or in the number of brief alcohol interventions received among at-risk drinkers in the two conditions .
RESULTS	However , those in integrated care condition received services sooner than those in the referral condition .
RESULTS	Those in the integrated care condition showed a significant decrease in the number of drinks in the past week and in the number of binge drinking episodes in the past 3 months while there were no significant changes in these outcomes among the at-risk drinkers in the enhanced referral condition .
CONCLUSIONS	At-risk drinkers in the integrated care condition were more likely to access treatment and decrease harmful drinking behaviors than those in the enhanced referral condition .
CONCLUSIONS	Implications for future research and treatment are discussed .

###12377205
BACKGROUND	The main concern in benign parotid surgery is complete removal of the lesion whilst avoiding any harm to the facial nerve .
BACKGROUND	Some time ago , surgeons also began to spare other structures including the great auricular nerve .
BACKGROUND	The purpose of this paper was to study these procedures prospectively and to evaluate the sensory recovery of this nerve .
METHODS	Fourteen patients undergoing parotid surgery with preservation of the great auricular nerve ( group A ) have been studied and compared with 10 patients whose operations involved sacrificing the nerve ( group B ) .
METHODS	The function of the great auricular nerve has been tested ( qualitatively and quantitatively ) before the operation , and postoperatively during the first few days and at 3 , 6 , 9 and 12 months .
RESULTS	Twelve months postoperatively , no area of anaesthesia was found in group A , whilst all patients in group B had some degree of sensory loss .
RESULTS	In group A , the qualitative and quantitative tests documented complete recovery of various types of surface sensitivity in 80 % of cases , with the remaining 20 % showing only a moderate reduction in comparison with the unoperated side .
CONCLUSIONS	From this study , it seems reasonable to spare the great auricular nerve during parotid surgery for benign disease because the procedure takes very little time , but guarantees a major improvement of postoperative sensitivity of the region innervated by the great auricular nerve .

###25042773
BACKGROUND	Websites and phone apps are increasingly used to track weights during weight loss interventions , yet the longitudinal accuracy of these self-reported weights is uncertain .
OBJECTIVE	Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic .
OBJECTIVE	We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5 % weight loss when using self-reported compared to clinic weights .
METHODS	This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction ( POWER ) trial , a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor .
METHODS	One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions .
METHODS	All intervention participants ( n = 277 ) received a digital scale and were asked to track their weight weekly on a study website .
METHODS	Research staff used a standard protocol to measure weight in the clinic .
METHODS	Differences ( self-reported weight - clinic weight ) indicate if self-report under ( - ) or over ( + ) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month ( n = 225 ) and 24-month ( n = 191 ) clinic visits .
METHODS	The absolute value of the differences ( absolute difference ) describes the overall accuracy .
RESULTS	Underestimation of self-reported weights increased significantly from 6 months ( mean -0.5 kg , SD 1.0 kg ) to 24 months ( mean -1.1 kg , SD 2.0 kg ; P = .002 ) .
RESULTS	The average absolute difference also increased from 6 months ( mean 0.7 kg , SD 0.8 kg ) to 24 months ( mean 1.3 , SD 1.8 kg ; P < .001 ) .
RESULTS	Participants who achieved the study weight loss goal at 24 months ( based on clinic weights ) had lower absolute differences ( P = .01 ) compared to those who did not meet this goal .
RESULTS	At 24 months , there was 9 % misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome .
RESULTS	At 24 months , those with self-reported weights ( n = 191 ) had three times the weight loss compared to those ( n = 73 ) without self-reported weights ( P < .001 ) .
CONCLUSIONS	Underestimation of weight increased over time and was associated with less weight loss .
CONCLUSIONS	In addition to intervention adherence , weight loss programs should emphasize accuracy in self-reporting .
BACKGROUND	ClinicalTrials.gov : NCT00783315 ; http://clinicaltrials.gov/show/NCT00783315 ( Archived by WebCite at http://www.webcitation.org/6R4gDAK5K ) .

###22025997
OBJECTIVE	To evaluate the efficacy of oily calcium hydroxide suspension ( OCHS ) in the of treatment of infrabony defects .
METHODS	Thirty patients with advanced chronic periodontitis , with one deep infrabony defect , were randomly treated with open flap debridement ( OFD ) ( control ) or OFD + OCHS ( test ) .
METHODS	Clinical measurements were performed at baseline and 9 months after treatment .
METHODS	Surgical reentry was performed after 9 months .
METHODS	The primary outcome variables were reduction in probing pocket depth ( PPD ) and gain in relative attachment level ( RAL ) .
METHODS	The secondary outcome was the reduction in depth of defect ( DOD ) measured intrasurgically .
RESULTS	A statistically significant reduction in PPD was observed at the end of 9 months , with the control group showing a mean reduction of 2.06 0.59 mm from baseline to 9 months and the test 1.06 1.22 mm ( P .05 ) .
RESULTS	There was no statistically significant gain in RAL at the end of 9 months , with a mean of 0.60 0.50 mm in the control group and 0.60 0.91 mm in the test ( P .05 ) .
RESULTS	No statistically significant difference was observed in DOD at 9 months , with a mean difference of 0.80 0.77 mm in the control group and 0.66 0.97 mm in the test ( P .05 ) .
CONCLUSIONS	Within the limitations of the study , OCHS failed to demonstrate any superior clinical outcomes in comparison with OFD .

###22513296
BACKGROUND	Genome-wide association studies ( GWAS ) have identified consistent associations with obesity .
BACKGROUND	However , the mechanisms remain unclear .
OBJECTIVE	The objective was to determine the association between obesity susceptibility loci and dietary intake .
METHODS	The association of GWAS-identified obesity risk alleles ( FTO , MC4R , SH2B1 , BDNF , INSIG2 , TNNI3K , NISCH-STAB1 , MTIF3 , MAP2K5 , QPCTL/GIPR , and PPARG ) with dietary intake , measured through food-frequency questionnaires , was investigated in 2075 participants from the Look AHEAD ( Action for Health in Diabetes ) clinical trial .
METHODS	We adjusted for age , sex , population stratification , and study site .
RESULTS	Obesity risk alleles at FTO rs1421085 significantly predicted more eating episodes per day ( P = 0.001 ) - an effect that persisted after adjustment for body weight ( P = 0.004 ) .
RESULTS	Risk variants within BDNF were significantly associated with more servings from the dairy product and the meat , eggs , nuts , and beans food groups ( P 0.004 ) .
RESULTS	The risk allele at SH2B1 rs4788099 was significantly associated with more servings of dairy products ( P = 0.001 ) , whereas the risk allele at TNNI3K rs1514176 was significantly associated with a lower percentage of energy from protein ( P = 0.002 ) .
CONCLUSIONS	These findings suggest that obesity risk loci may affect the pattern and content of food consumption among overweight or obese individuals with type 2 diabetes .
CONCLUSIONS	The Look AHEAD Genetic Ancillary Study was registered at clinicaltrials.gov as NCT01270763 and the Look AHEAD study as NCT00017953 .

###14563182
OBJECTIVE	To determine the accuracy of the most common available tests for the diagnosis of Helicobacter pylori infection in an unselected and untreated population of patients .
METHODS	Prospective study including 314 unselected patients from a population of 814 patients referred for upper endoscopy at one hospital .
METHODS	H. pylori infection was diagnosed by rapid urease test ( RUT ) , histology , culture and 13C-urea-breath test ( UBT ) and serum IgG ( EIA ) .
METHODS	H. pylori infection was defined as positive if culture or at least two of the other tests were positive .
RESULTS	The prevalence of H. pylori infection in this population was 72 % .
RESULTS	The diagnostic test with the greatest combination of sensitivity ( 97 % ) and specificity ( 100 % ) was the UBT .
RESULTS	EIA had a good sensitivity ( 96 % ) , but it was the test with the least specificity ( 71 % ) .
RESULTS	RUT , histology and culture showed a high specificity ( > 98 % ) but a sensitivity lower than 90 % .
RESULTS	In elderly patients ( > 65 years old , n = 120 ) , UBT was also the test with the greatest combination of sensitivity ( 94 % ) and specificity ( 100 % ) .
CONCLUSIONS	In conditions of real clinical practice the 13C-urea-breath test is a reliable test for H. pylori diagnosis , both in young and elderly patients .

###22276820
BACKGROUND	Bevacizumab , a monoclonal antibody against vascular endothelial growth factor A , has shown clinical efficacy in patients with human epidermal growth factor receptor 2 ( HER2 ) - negative metastatic breast cancer .
BACKGROUND	We evaluated the efficacy , measured according to the rate of pathological complete response ( absence of invasive and intraductal disease in the breast and the axillary lymph nodes ) , and the safety of adding bevacizumab to neoadjuvant chemotherapy in patients with early-stage breast cancer .
METHODS	We randomly assigned 1948 patients with a median tumor size of 40 mm on palpation to receive neoadjuvant epirubicin and cyclophosphamide followed by docetaxel , with or without concomitant bevacizumab .
METHODS	Patients with untreated HER2-negative breast cancer were eligible if they had large tumors , hormone-receptor-negative disease , or hormone-receptor-positive disease with palpable nodes or positive findings on sentinel-node biopsy , and no increased cardiovascular or bleeding risk .
RESULTS	Overall , the rates of pathological complete response were 14.9 % with epirubicin and cyclophosphamide followed by docetaxel and 18.4 % with epirubicin and cyclophosphamide followed by docetaxel plus bevacizumab ( odds ratio with addition of bevacizumab , 1.29 ; 95 % confidence interval , 1.02 to 1.65 ; P = 0.04 ) ; the corresponding rates of pathological complete response were 27.9 % and 39.3 % among 663 patients with triple-negative tumors ( P = 0.003 ) and 7.8 % and 7.7 % among 1262 patients with hormone-receptor-positive tumors ( P = 1.00 ) .
RESULTS	Breast-conserving surgery was possible in 66.6 % of the patients in both groups .
RESULTS	The addition of bevacizumab , as compared with neoadjuvant therapy alone , was associated with a higher incidence of grade 3 or 4 toxic effects ( febrile neutropenia , mucositis , the hand-foot syndrome , infection , and hypertension ) but with a similar incidence of surgical complications .
CONCLUSIONS	The addition of bevacizumab to neoadjuvant chemotherapy significantly increased the rate of pathological complete response among patients with HER2-negative early-stage breast cancer .
CONCLUSIONS	Efficacy was restricted primarily to patients with triple-negative tumors , in whom the pathological complete response is considered to be a reliable predictor of long-term outcome .
CONCLUSIONS	( Funded by Sanofi-Aventis and Roche , Germany ; ClinicalTrials.gov number , NCT00567554 . )

###19165757
OBJECTIVE	Palliative care ( PC ) nurses experience several recurrent organizational , professional , and individual challenges .
OBJECTIVE	To address existential and emotional demands , the meaning-centered intervention was recently developed .
OBJECTIVE	The intervention applied didactic and process-oriented strategies , including guided reflections , experiential exercises , and education based on themes of Viktor Frankl 's logotherapy .
OBJECTIVE	The objective of this study was to test its efficiency to improve job satisfaction and quality of life in PC nurses from three regional districts in Quebec Province , Canada .
METHODS	A randomized waiting-list group design was conducted , intervention group ( n = 56 ) versus waiting-list group ( n = 53 ) .
METHODS	Job satisfaction , perception of benefits of working in PC , and spiritual and emotional quality of life were measured at pre - , posttest , and 3-month follow-up .
RESULTS	The PC nurses in the experimental group reported more perceived benefits of working in PC after the intervention and at follow-up .
RESULTS	Spiritual and emotional quality of life remained , however , unaffected by the intervention .
CONCLUSIONS	To explain null findings , theoretical and methodological challenges , related to existential interventions , such as choice of outcomes , and selection bias ( participants recruited were healthy workers ) are discussed .
CONCLUSIONS	Future directions and strategies to deal with those issues are proposed .

###19733054
BACKGROUND	This study compared anxiety in two groups of women undergoing elective cesarean delivery to ascertain if their partner 's presence during neuraxial anesthesia placement affected patients ' overall anxiety levels .
METHODS	Three hundred fifteen patient-partner dyads were randomized to two groups : group 1 partners were present in the operating room during neuraxial anesthesia placement while group 2 partners remained outside the operating room during placement .
METHODS	Before surgery , all patient-partner dyads completed a survey of demographics , anesthetic experiences and baseline anxiety .
METHODS	Anxiety levels were rated using a visual analogue scale ( VAS ) and the state portion of the Spielberger State-Trait Anxiety Inventory .
RESULTS	The mean change in anxiety as measured by VAS among patients whose partners were present in the operating room for neuraxial anesthetic placement decreased from before to after the procedure ( -4.5 + / -25.8 ; P = 0.03 ; 95 % CI -8.55 , -0.45 ) ; the mean change in anxiety in patients whose partners were not present did not alter significantly ( +1.9 + / - 25.3 ; P = 0.34 ; 95 % CI 6.68 , 12.12 ) .
RESULTS	Anxiety was increased among partners who were not present ( +9.4 , P < 0.001 ) .
CONCLUSIONS	Although patients whose partners were present in the operating room at the time of neuraxial anesthesia placement reported less anxiety over the time of the study than did patients whose partners were not present , these differences were small and are not considered to be clinically important .
CONCLUSIONS	Increased anxiety among partners who were not present at neuraxial placements warrants further study .

###16142748
OBJECTIVE	Interleukin-15 ( IL-15 ) is a proinflammatory , innate response cytokine that mediates pleiotropic effector function in rheumatoid arthritis ( RA ) inflammatory synovitis .
OBJECTIVE	Our objective was to study the ability of HuMax-IL15 , a human IgG1 anti-IL-15 monoclonal antibody , to neutralize exogenous and endogenous IL-15 activity in vitro and to perform a phase I-II dose-escalation trial with HuMax-IL15 in patients with active RA .
METHODS	Mononuclear cells from blood and synovial fluid ( SF ) of RA patients were isolated and cultured in vitro under experimental conditions involving the addition of HuMax-IL15 .
METHODS	HuMax-IL15 was administered to 30 RA patients who received no other disease-modifying antirheumatic drugs in a 12-week , dose-ascending , placebo-controlled , double-blind , phase I-II proof-of-concept study .
RESULTS	In vitro studies showed that HuMax-IL15 suppressed proliferation and induced apoptosis in an IL-15-dependent cell line , BDB2 , and was capable of suppressing the release of interferon-gamma by synovial fluid mononuclear cell ( SFMC ) cultures induced by exogenous IL-15 .
RESULTS	Furthermore , HuMax-IL15 F ( ab ' ) 2 fragments suppressed exogenous IL-15-induced CD69 expression in RA peripheral blood mononuclear cells and SFMCs , which indicates that HuMax-IL15 can specifically neutralize several biologic effects of IL-15 in synovial tissue in vitro .
RESULTS	In a phase I-II clinical trial , HuMax-IL15 was well tolerated clinically , with no significant effects on T lymphocyte subset and natural killer cell numbers .
RESULTS	Substantial improvements in disease activity were observed according to the American College of Rheumatology criteria for 20 % improvement ( 63 % of patients ) , 50 % improvement ( 38 % ) , and 70 % improvement ( 25 % ) .
CONCLUSIONS	These clinical data suggest for the first time that IL-15 could represent a novel therapeutic target in RA .

###21595978
BACKGROUND	Tailored nutrition interventions have been shown to be more effective than non-tailored materials in changing dietary behaviours , particularly fat intake and fruit and vegetable intake .
BACKGROUND	But further research examining efficacy of tailored nutrition education in comparison to other nutrition education methods and across a wider range of dietary behaviours is needed .
BACKGROUND	The Stages to Healthy Eating Patterns Study ( STEPs ) was an intervention study , in middle-aged adults with cardiovascular risk factors , to examine the effectiveness of printed , tailored , iterative dietary feedback delivered by mail in improving short-term dietary behaviour in the areas of saturated fat , fruit , vegetable and grain and cereal intake .
METHODS	STEPs was a 3-month randomised controlled trial with a pre and post-test design .
METHODS	There were three experimental conditions : 1 ) tailored , iterative , printed dietary feedback ( TF ) with three instalments mail-delivered over a 3-month period that were re-tailored to most recent assessment of dietary intake , intention to change and assessment of self-adequacy of dietary intake .
METHODS	Tailoring for dietary intake was performed on data from a validated 63-item combination FFQ designed for the purpose 2 ) small group nutrition education sessions ( GE ) : consisting of two 90-minute dietitian-led small group nutrition education sessions and 3 ) and a wait-listed control ( C ) group who completed the dietary measures and socio-demographic questionnaires at baseline and 3-months later .
METHODS	Dietary outcome measures in the areas of saturated fat intake ( g ) , and the intake of fruit ( serves ) , vegetables ( serves ) , grain and cereals as total and wholegrain ( serves ) were collected using 7-day estimated dietary records .
METHODS	Descriptive statistics , paired t-tests and general linear models adjusted for baseline dietary intake , age and gender were used to examine the effectiveness of different nutrition interventions .
RESULTS	The TF group reported a significantly greater increase in fruit intake ( 0.3 serves/d P = 0.031 ) in comparison to GE and the C group .
RESULTS	All three intervention groups showed a reduction in total saturated fat intake .
RESULTS	GE also had a within-group increase in mean vegetable intake after 3 months , but this increase was not different from changes in the other groups .
CONCLUSIONS	In this study , printed , tailored , iterative dietary feedback was more effective than small group nutrition education in improving the short-term fruit intake behaviour , and as effective in improving saturated fat intake of middle-aged adults with cardiovascular risk factors .
CONCLUSIONS	This showed that a low-level dietary intervention could achieve modest dietary behaviour changes that are of public health significance .

###21134507
BACKGROUND	The study was conducted to assess socio-behavioral and biological factors associated with unplanned pregnancy in the US cohort of a microbicide trial .
METHODS	We conducted a mixed-method , nested case-control study of risk factors for pregnancy within the US cohort of the microbicide trial HPTN 035 .
METHODS	We developed an instrument to assess attitudes and beliefs about fertility control/contraceptive utilization among 122 women .
METHODS	Cases were HPTN 035 participants who became pregnant while enrolled , matched by time on study 1:4 with controls .
METHODS	Univariable and multivariable analysis were performed with pregnancy as the outcome of interest .
RESULTS	Contraceptive method change during the trial was associated with unplanned pregnancy ( OR = 1.76 ) .
RESULTS	Participant desire/partners ' desire for future children ( OR = 4.95 ) and young age ( OR = 0.88 annually above age 19 years ) were independently associated with unintended pregnancy .
CONCLUSIONS	Within a trial that enroll heterosexually active women , there may be ways to identify those at highest risk of becoming pregnant a priori .

###18279476
BACKGROUND	Dextromethorphan is widely used as a cough suppressant in over the counter medications .
BACKGROUND	Its efficacy in altering cough reflex sensitivity has been shown in healthy volunteers .
BACKGROUND	In contrast evidence for an effect on clinically important cough is poor .
CONCLUSIONS	A significant decrease in evoked cough was seen with dextromethorphan compared with placebo .
CONCLUSIONS	However , both placebo and active treatment improved subjective data to a similar degree .
CONCLUSIONS	We doubt the validity of currently used objective tests in the investigation of antitussives .
OBJECTIVE	Using an established model of smokers cough we measured the antitussive effects of dextromethorphan compared with placebo .
METHODS	The study was a randomized , double-blind placebo controlled , crossover comparison of 22 mg 0.8 ml ( -1 ) dextromethorphan delivered pregastrically with matched placebo .
METHODS	Objective and subjective measurements of cough were recorded .
METHODS	Subjective measures included a daily diary record of cough symptoms and the Leicester quality of life questionnaire .
METHODS	Cough frequency was recorded using a manual cough counter .
METHODS	The objective measure of cough reflex sensitivity was the citric acid , dose-response cough challenge .
RESULTS	Dextromethorphan was significantly associated with an increase in the concentration of citric acid eliciting an average of two coughs/inhalation ( C2 ) when compared with placebo , 1 h post dose by 0.49 mM ( 95 % CI 0.05 , 0.45 , geometric mean 3.09 ) compared with placebo 0.24 mM ( geometric mean 1.74 ) P < 0.05 and at 2 h 0.57 mM ( 95 % CI 0.01 , 0.43 , geometric mean 3.75 ) compared with placebo 0.34 mM ( geometric mean 2.19 ) P < 0.05 ) .
RESULTS	There was a highly significant improvement in the subjective data when compared with baseline .
RESULTS	However , there was no significant difference between placebo and active treatment .
RESULTS	No correlation was seen between cough sensitivity to citric acid and recorded cough counts or symptoms .
RESULTS	When both subjective and objective data were compared with screening data there was evidence of a marked ` placebo ' effect .
CONCLUSIONS	The objective measure of cough sensitivity demonstrates dextromethorphan effectively diminishes the cough reflex sensitivity .
CONCLUSIONS	However , subjective measures do not support this .
CONCLUSIONS	Other studies support these findings , which may represent a profound sensitivity of the cough reflex to higher influences .

###17389702
BACKGROUND	Although some endocrine surgeons administer Lugol solution to decrease thyroid gland vascularity , there is still not an agreement on its effectiveness .
OBJECTIVE	The aims of this clinical trial are to evaluate thyroid blood flow and microvessel density in patients with Graves ' disease who received Lugol solution treatment preoperatively .
METHODS	This was a prospective clinical trial .
METHODS	This clinical trial took place at a tertiary referral center .
METHODS	Thirty-six patients were randomly assigned to receive either preoperative treatment with Lugol solution ( group 1 , n = 17 ) or no preoperative treatment with Lugol solution ( group 2 , n = 19 ) .
METHODS	Blood flow through the thyroid arteries of patients with Graves ' disease was measured by color flow Doppler ultrasonography .
METHODS	The microvessel density ( MVD ) was assessed by immunohistochemical and Western blot analysis of the level of expression of CD-34 in thyroid tissue .
METHODS	The weight and blood loss of the thyroid gland were measured in all patients .
RESULTS	The mean blood flow , MVD , CD-34 expression , and blood loss in group 1 patients were significantly lower than those in group 2 patients .
RESULTS	There was a negative correlation between Lugol solution treatment and blood flow ( r ( s ) = -0.629 ; P = 0.0001 ) , blood loss ( r ( s ) = -0.621 ; P = 0.0001 ) , MVD ( r ( s ) = -0.865 ; P = 0.0001 ) , and CD-34 expression ( r ( s ) = -0.865 ; P = 0.0001 ) .
RESULTS	According to logistic regression analysis , Lugol solution treatment resulted in a 9.33-fold decreased rate of intraoperative blood loss .
CONCLUSIONS	Preoperative Lugol solution treatment decreased the rate of blood flow , thyroid vascularity , and intraoperative blood loss during thyroidectomy .

###24244703
BACKGROUND	Lifestyle interventions affect patients ' risk factors for metabolic syndrome ( MeSy ) , a pre-stage to cardiovascular diseases , diabetes and related complications .
BACKGROUND	An effective lifestyle intervention is the Swedish Bjrkns intervention , a 3-year randomized controlled trial in primary care for MeSy patients .
BACKGROUND	To include future disease-related cost and health consequences in a cost-effectiveness analysis , a simulation model was used to estimate the short-term ( 3-year ) and long-term ( lifelong ) cost-effectiveness of the Bjrkns study .
RESULTS	A Markov micro-simulation model was used to predict the cost and quality-adjusted life years ( QALYs ) for MeSy-related diseases based on ten risk factors .
RESULTS	Model inputs were levels of individual risk factors at baseline and at the third year .
RESULTS	The model estimated short-term and long-term costs and QALYs for the intervention and control groups .
RESULTS	The cost-effectiveness of the intervention was assessed using differences-in-differences approach to compare the changes between the groups in the health care and societal perspectives , using a 3 % discount rate .
RESULTS	A 95 % confidence interval ( CI ) , based on bootstrapping , and sensitivity analyses describe the uncertainty in the estimates .
RESULTS	In the short-term , costs are predicted to increase over time in both groups , but less in the intervention group , resulting in an average cost saving/reduction of US$ -700 ( in 2012 , US$ 1 = six point five seven SEK ) and US$ -500 , in the societal and health care perspectives .
RESULTS	The long-term estimate also predicts increased costs , but considerably less in the intervention group : US$ -7,300 ( 95 % CI : US$ -19,700 to US$ -1,000 ) in the societal , and US$ -1,500 ( 95 % CI : US$ -5,400 to US$ 2,650 ) in the health care perspective .
RESULTS	As intervention costs were US$ 211 per participant , the intervention would result in cost saving .
RESULTS	Furthermore , in the long-term an estimated 0.46 QALYs ( 95 % CI : 0.12 to 0.69 ) per participant would be gained .
CONCLUSIONS	The Swedish Bjrkns study appears to reduce demands on societal and health care resources and increase health-related quality of life .

###18712575
BACKGROUND	Visceral fat , especially the greater omentum , seems to be an important factor in the development of some metabolic disturbances such as insulin resistance , hyperglycemia , and dyslipidemia .
BACKGROUND	Therefore , we wanted to evaluate the influence of resecting or leaving in situ the greater omentum in a group of patients with morbid obesity .
METHODS	Seventy patients with morbid obesity were submitted to laparotomic resectional gastric bypass and an omentectomy was randomly performed in some patients .
METHODS	Body mass index ( BMI ) , serum levels of sugar , insulin , total cholesterol , and triglycerides were determined prior to surgery and followed up on for 2 years afterwards .
RESULTS	Two years after surgery , no differences were seen in BMI levels in either group .
RESULTS	Blood sugar levels , serum insulin , total cholesterol levels , and serum triglycerides had similar values in both groups .
RESULTS	Arterial hypertension had similar behavior .
CONCLUSIONS	Based on these results , omentectomy is not justified as part of bariatric surgery .
CONCLUSIONS	Its theoretical advantages are not reflected in this prospective random trial .

###25227656
OBJECTIVE	Evaluation of the safety and efficacy of pazopanib , a multikinase angiogenesis inhibitor , in a single-arm , open-label , extension study ( VEG107769/NCT00387764 ) for placebo-treated patients with advanced renal cell carcinoma ( RCC ) from a randomized , double-blind , placebo-controlled phase III study ( VEG105192/NCT00334282 ) .
METHODS	Patients received pazopanib 800 mg/day .
METHODS	The primary endpoint was the safety and tolerability of pazopanib treatment .
METHODS	Secondary endpoints included response rate per Response Evaluation Criteria in Solid Tumors , progression-free survival ( PFS ) , and overall survival ( OS ) .
RESULTS	Seventy-nine placebo-treated patients from VEG105192/NCT00334282 who experienced disease progression and one pazopanib-treated patient ( an exemption ) were enrolled .
RESULTS	Forty-one patients ( 51 % ) were treatment-naive ; 39 ( 49 % ) were cytokine-pretreated .
RESULTS	Median exposure to pazopanib was 9.7 months .
RESULTS	All patients had discontinued pazopanib at the time of analysis .
RESULTS	The most common reason for discontinuation was disease progression ( 61 % ) .
RESULTS	The most common adverse events were hypertension ( 45 % ) , diarrhea ( 45 % ) , hair color changes ( 44 % ) , anorexia ( 30 % ) , and nausea ( 25 % ) .
RESULTS	The response rate was 37.5 % [ 95 % confidence interval ( CI ) : 26.9-48 .1 ] ; median PFS was 9.2 months ( 95 % CI : 7.3-12 .0 ) ; median OS was 23.5 months ( 95 % CI : 16.3-28 .0 ) .
CONCLUSIONS	Efficacy and safety profiles for pazopanib in this extension study of patients with RCC previously treated with placebo were very similar to those observed for pazopanib-treated patients in the pivotal phase III study .

###18956517
OBJECTIVE	Radiotherapy of Hodgkin 's Lymphoma has evolved from extended-field to involved-field ( IF ) radiotherapy reducing toxicity whilst maintaining high cure rates .
OBJECTIVE	Recent publications recommend further reduction in the radiation field to involved-node ( IN ) radiotherapy ; however , this concept has never been tested in a randomized trial .
OBJECTIVE	The German Hodgkin Study Group aims to compare it with standard IF radiotherapy in their future HD17 trial .
METHODS	ALL patients must be examined by the radiation oncologist before the start of chemotherapy .
METHODS	At that time , patients must have complete staging CT scans .
METHODS	For patients with IN radiotherapy , a radiation planning CT before and after chemotherapy with patients in the treatment position is recommended .
METHODS	Fusion techniques , allowing the overlapping of the pre - and postchemotherapy CT scans , should be used .
METHODS	Usage of PET-CT scans with patients in the treatment position is recommended , whenever possible .
RESULTS	The clinical target volume encompasses the initial volume of the Lymph node ( s ) before chemotherapy and incorporates the initial Location and extent of the disease taking the displacement of the normal tissues into account .
RESULTS	The margin of the planning target volume should be 2 cm in axial and 3 cm in craniocaudal direction .
RESULTS	If necessary , it can be reduced to 1-1 .5 cm .
RESULTS	To minimize Lung and cardiac toxicity , the target definition in the mediastinum is different .
CONCLUSIONS	The concept of IN radiotherapy has been proposed as a means to further improve the therapeutic ratio by reducing the risk of radiation-induced toxicity , including second malignancies .
CONCLUSIONS	Field sizes wiLL further decrease compared to IF radiotherapy .

###7575117
OBJECTIVE	To determine whether an intensified follow-up of patients with colorectal cancer can lead to improved reresectability and a better long-term survival .
METHODS	A prospective randomized trial of 106 patients .
METHODS	Oulu University Hospital , a referral center in northern Finland .
METHODS	A total of 106 consecutive patients who underwent radical resection for colorectal cancer , 54 of whom were randomized into a conventional follow-up group and 52 into an intensified follow-up group .
METHODS	After a 5-year follow-up , the time of detection of recurrence , the recurrence rates , the first method showing recurrence , the mode of recurrence , reresectability , and survival were compared between the groups .
RESULTS	The recurrences were identified earlier in the intensified follow-up group than in the conventional follow-up group ( mean + / - SD , 10 + / - 5 months vs 15 + / - 10 months ) .
RESULTS	The overall recurrence rate was 41 % , with 39 % in the conventional group and 42 % in the intensified group .
RESULTS	Carcinoembryonic antigen determination was the most common method showing recurrence in both groups .
RESULTS	Endoscopy and ultrasound were beneficial in the intensified follow-up group , but computed tomography failed to improve the diagnostics .
RESULTS	The mode of recurrence did not differ between the groups .
RESULTS	Radical resections were performed on 19 % ( 8/43 ) of the patients , 14 % ( 3/21 ) in the conventional group and 22 % ( 5/22 ) in the intensified group .
RESULTS	The cumulative 5-year survival was 54 % in the conventional group and 59 % in the intensified group .
CONCLUSIONS	Earlier detection of recurrent colorectal cancer by intensified follow-up does not lead to either significantly increased reresectability or improved 5-year survival .

###10792119
BACKGROUND	The efficacy of several prokinetic drugs on dyspeptic symptoms and on gastric emptying rates are well-established in patients with functional dyspepsia , but formal studies comparing different prokinetic drugs are lacking .
OBJECTIVE	To compare the effects of chronic oral administration of cisapride and levosulpiride in patients with functional dyspepsia and delayed gastric emptying .
METHODS	In a double-blind crossover comparison , the effects of a 4-week administration of levosulpiride ( 25 mg t.d.s. ) and cisapride ( 10 mg t.d.s. ) on the gastric emptying rate and on symptoms were evaluated in 30 dyspeptic patients with functional gastroparesis .
METHODS	At the beginning of the study and after levosulpiride or cisapride treatment , the gastric emptying time of a standard meal was measured by 13C-octanoic acid breath test .
METHODS	Gastrointestinal symptom scores were also evaluated .
RESULTS	The efficacy of levosulpiride was similar to that of cisapride in significantly shortening ( P < 0.001 ) the t1/2 of gastric emptying .
RESULTS	No significant differences were observed between the two treatments with regards to improvements in total symptom scores .
RESULTS	However , levosulpiride was significantly more effective ( P < 0.01 ) than cisapride in improving the impact of symptoms on the patients ' every-day activities and in improving individual symptoms such as nausea , vomiting and early postprandial satiety .
CONCLUSIONS	The efficacy of levosulpiride and cisapride in reducing gastric emptying times with no relevant side-effects is similar .
CONCLUSIONS	The impact of symptoms on patients ' everyday activities and the improvement of some symptoms such as nausea , vomiting and early satiety was more evident with levosulpiride than cisapride .

###17345064
BACKGROUND	Clinical studies have shown that topiramate , an anticonvulsant medication , may be effective as a treatment for smoking cessation .
BACKGROUND	However , less is known about topiramate effects on nicotine withdrawal and craving and its interactions with a smoked cigarette .
OBJECTIVE	The objective of this study was to investigate the effects of topiramate treatment on abstinence-related nicotine withdrawal , cue-induced cigarette craving , and the acute effects of a smoked cigarette .
METHODS	Fifteen female and 25 male cigarette smokers were randomly assigned to 9-day treatment with topiramate ( final titration dose , 75 mg/day ) or placebo .
METHODS	On the last day of treatment , after a 3-h smoke-free abstinence period , participants were evaluated for symptoms of nicotine withdrawal and then underwent cigarette and neutral cue reactivity testing .
METHODS	Thirty minutes after completing cue exposure testing , participants were then evaluated for the acute effects of a smoked cigarette .
METHODS	Cue reactivity and acute smoking measures included subjective ratings of cigarette craving and withdrawal and physiological measures of skin conductance and temperature , heart rate , and blood pressure .
METHODS	In addition , smoking topography was measured using a puff volume apparatus .
RESULTS	Topiramate treatment enhanced subjective ratings of withdrawal after the 3-h abstinence period and reduced pre-cue skin conductance levels .
RESULTS	Cigarette cue exposure resulted in a moderate increase in craving , which was unaffected by treatment .
RESULTS	Topiramate treatment enhanced the rewarding effects of a smoked cigarette , even while participants smoked less per puff and achieved lower plasma nicotine levels .
CONCLUSIONS	Results suggest that topiramate enhances both nicotine withdrawal and reward .
CONCLUSIONS	These findings question the utility of topiramate treatment for smoking cessation .

###17562631
OBJECTIVE	To explore virtual reality ( VR ) as a distraction intervention to relieve symptom distress in adults receiving chemotherapy treatments for breast , colon , and lung cancer .
METHODS	Crossover design in which participants served as their own control .
METHODS	Outpatient clinic at a comprehensive cancer center in the southeastern United States .
METHODS	123 adults receiving initial chemotherapy treatments .
METHODS	Participants were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and then received no intervention ( control ) during an alternate matched chemotherapy treatment .
METHODS	The Adapted Symptom Distress Scale-2 , Revised Piper Fatigue Scale , and State Anxiety Inventory were used to measure symptom distress .
METHODS	The Presence Questionnaire and an open-ended questionnaire were used to evaluate the subjects ' VR experience .
METHODS	The influence of type of cancer , age , and gender on symptom outcomes was explored .
METHODS	Mixed models were used to test for differences in levels of symptom distress .
METHODS	Virtual reality and symptom distress .
RESULTS	Patients had an altered perception of time ( p < 0.001 ) when using VR , which validates the distracting capacity of the intervention .
RESULTS	Evaluation of the intervention indicated that patients believed the head-mounted device was easy to use , they experienced no cyber-sickness , and 82 % would use VR again .
RESULTS	However , analysis demonstrated no significant differences in symptom distress immediately or two days following chemotherapy treatments .
CONCLUSIONS	Patients stated that using VR made the treatment seem shorter and that chemotherapy treatments with VR were better than treatments without the distraction intervention .
CONCLUSIONS	However , positive experiences did not result in a decrease in symptom distress .
CONCLUSIONS	The findings support the idea that using VR can help to make chemotherapy treatments more tolerable , but clinicians should not assume that use of VR will improve chemotherapy-related symptoms .
CONCLUSIONS	Patients found using VR during chemotherapy treatments to be enjoyable .
CONCLUSIONS	VR is a feasible and cost-effective distraction intervention to implement in the clinical setting .

###24386491
BACKGROUND	A reduced exercise capacity is associated with increased morbidity and mortality in patients with advanced non-small cell lung cancer ( NSCLC ) .
BACKGROUND	Therapeutic exercise can be beneficial and neuromuscular electrical stimulation ( NMES ) of the quadriceps muscles may represent a practical approach .
BACKGROUND	The primary aim of this study was to determine the acceptability of NMES of the quadriceps to patients with NSCLC used alongside palliative chemotherapy .
BACKGROUND	Secondary aims explored aspects of safety and efficacy of NMES in this setting .
METHODS	Patients with advanced NSCLC due to receive first-line palliative chemotherapy were randomized to usual care with or without NMES .
METHODS	They were asked to undertake 30 minute sessions of NMES , ideally daily , but as a minimum , three times weekly .
METHODS	For NMES to be considered acceptable , it was predetermined that 80 % of patients should achieve this minimum level of adherence .
METHODS	Qualitative interviews were held with a subset of patients to explore factors influencing adherence .
METHODS	Safety was assessed according to the Common Terminology Criteria for Adverse Events .
METHODS	Quadriceps muscle strength , thigh lean mass , and physical activity level were assessed at baseline and after three cycles of chemotherapy .
RESULTS	49 patients ( 28 male , median ( IQR ) age 69 ( 64-75 ) years ) participated .
RESULTS	Of 30 randomized to NMES , 18 were eligible for the primary endpoint , of whom 9 ( 50 % [ 90 % CI , 29 to 71 ] ) met the minimum level of adherence .
RESULTS	Adherence was enhanced by incorporating sessions into a daily routine and hindered by undesirable effects of chemotherapy .
RESULTS	There were no serious adverse events related to NMES , nor significant differences in quadriceps muscle strength , thigh lean mass or physical activity level between groups .
CONCLUSIONS	NMES is not acceptable in this setting , nor was there a suggestion of benefit .
CONCLUSIONS	The need remains to explore NMES in patients with cancer in other settings .
BACKGROUND	Current Controlled Trials ISRCTN 42944026 www.controlled-trials.com/ISRCTN42944026 .

###12765886
BACKGROUND	Anti-inflammatory treatment with glucocorticoids during cardiopulmonary bypass can reduce inflammatory mediator release , but the effects of glucocorticoid on outcome are controversial .
METHODS	We studied the effects of dexamethasone on clinical course , C-reactive protein , von Willebrand factor antigen ( vWf : Ag ) and S100B in a randomized masked study of children after open cardiac surgery .
METHODS	Twenty children weighing > 10 kg received dexamethasone ( 1 mg kg ( -1 ) ) and 20 controls received saline after induction of anaesthesia .
METHODS	We measured vWf : Ag as a marker of endothelial activation , S100B as a marker of cerebral protein release and C-reactive protein as a marker of inflammatory activity .
METHODS	Oxygenation , body temperature , fluid balance , leucocyte and platelet counts , days in the intensive care unit ( ICU ) and days on mechanical ventilation were noted .
RESULTS	Dexamethasone decreased C-reactive protein concentration on the first postoperative day ( P < 0.05 ) , but did not affect the release of vWf : Ag or S100B .
RESULTS	There was no significant difference in oxygenation , body temperature , fluid balance , leucocyte and platelet counts , days in the ICU or days on mechanical ventilation between the placebo and dexamethasone-treated groups .
CONCLUSIONS	Administration of dexamethasone before cardiopulmonary bypass for paediatric cardiac surgery decreased the inflammatory response , but did not affect the immediate features after surgery or changes in vWf : Ag or S100B .

###9275441
OBJECTIVE	To improve the safety and the effect on induction of labor with oxytocin .
METHODS	112 cases were selected for labor induction with feedback pulsatile oxytocin under the monitoring of uterine contraction controller ( study group ) .
METHODS	112 cases were selected with continuous intravenous infusion of oxytocin as a control ( control group ) .
METHODS	The dose of oxytocin and the pulse time-point were adjusted .
METHODS	The effects of labor induction in the 2 groups were compared .
RESULTS	The most suitable time-point was 1.5 minute after the uterine contraction .
RESULTS	The best administration duration was 20 seconds .
RESULTS	But the most suitable dose varied individually , generally 12-25 mU .
RESULTS	The mean time to establish contraction in study group was significantly shorter ( 1.9 + / - 1.2 min ) than that of the control group ( 115.5 + / - 72.3 min , P < 0.001 ) .
RESULTS	The average dose of oxytocin administered per hour was significantly less in the study group ( 312 + / - 64 mU ) than that of the control group ( 735 + / - 125 mU , P < 0.001 ) the success rate was 100 % in study group whereas only 90.2 % in control group ( P < 0.01 ) .
RESULTS	The total duration of labor in the study group was 6.9 + / - 4.7 hours in contrast to 20.4 + / - 10.9 hours in the control group ( P < 0.001 ) .
RESULTS	The occurrences of dystocia , postpartum hemorrhage and neonatal asphyxia were lower in study group .
CONCLUSIONS	This study proved that the administration of oxytocin with the feedback pulsatile oxytocin system is easier to establish the effective uterine contraction , and it is a more physiologic and effective regimen for induction of labor .

###22372273
OBJECTIVE	The aim of the present study was to compare diagnostic assessments of anterior tooth and bone status in a randomised cohort of pre-orthodontic patients using panoramic and periapical radiographs .
METHODS	Four hundred and forty-four cases with matched periapical and panoramic radiographs were examined by three observers .
METHODS	Two were final-year postgraduate endodontic students and the other , a final-year Honours degree dental student .
METHODS	Multi-rater Kappa values were used to assess the reliability of the observers , with a value of 1 equating to complete agreement .
RESULTS	With the exception of endodontic Class 1 and 2 palatal invaginations , reliability exceeded 0.95 for all three observers .
RESULTS	An assessment of the graduate endodontic students revealed only a marginal increase in the kappa values .
RESULTS	Statistical analysis ( p < 0.05 ) determined that developmental anomalies or tooth/bone pathoses were more reliably detected by observers using periapical radiographs compared with panoramic films .
RESULTS	This finding has relevance given the likelihood of anterior dental trauma among young children .
CONCLUSIONS	While there have been considerable improvements in the quality of dental panoramic radiography , the present study indicated that a reliable pre-orthodontic or post-trauma diagnostic assessment should include both panoramic and intra-oral radiographs .

###10392251
OBJECTIVE	Anal fistula surgery is associated with considerable morbidity , mainly related to anal incontinence .
OBJECTIVE	As promising results of the use of fibrin glue in the treatment of complex anal fistulas were recently shown , we planned to do a randomized trial comparing the use of fibrin glue and surgery in the treatment of perianal fistulas .
OBJECTIVE	There were no reports of the use of fibrin glue in the management of previously untreated anal fistulas .
METHODS	Prior to the planned study a pretrial pilot series of 10 patients with different perianal fistulas were treated .
METHODS	Informed consent was obtained from every patient .
METHODS	Under spinal anesthesia , the fistula track was identified and brushed to remove granulous tissue , then washed with hydrogen peroxide and thereafter filled with fibrin glue .
RESULTS	We performed fibrin gluing on 10 patients with perianal fistulas of different etiology and type .
RESULTS	The gluing was done once to 7 patients , twice to 2 and three times to one patient .
RESULTS	In all but one patient the fistula and symptoms recurred after only one month .
RESULTS	One patient with a low trans-sphincteric fistula of which the internal opening was not found , was symptom-free for 6 months .
RESULTS	At the one-month follow-up visit the external opening of the fistula was almost unidentifiable , suggesting that the fistula had healed .
RESULTS	However , due to recurrence fistulotomy was performed after 6 months .
CONCLUSIONS	Fistulas around the anus , with or without associated inflammatory bowel disease , do not seem to heal after fibrin gluing .

###22274735
BACKGROUND	Intraocular pressure ( IOP ) has been shown to increase during prone spine surgery .
BACKGROUND	Although propofol and sevoflurane have been widely used during such surgery , there have been no data to compare the IOP changes under propofol and sevoflurane anesthesia .
BACKGROUND	The present study was therefore conducted to investigate IOP changes under propofol and sevoflurane anesthesia during prone spine surgery .
METHODS	After institutional approval and informed consent , 24 patients undergoing prone spine surgery were studied .
METHODS	Patients were randomly allocated to 1 of 2 groups : the propofol or sevoflurane group .
METHODS	Propofol or sevoflurane was administered to maintain the bispectral index between 40 and 60 .
METHODS	The IOP was measured using a Tonopen XL hand-held tonometer 10 minutes after induction of anesthesia in the supine position ( baseline ) , 10 , 60 , and 120 minutes after positioning in the prone position , and 10 minutes after returning to the supine position .
RESULTS	There were no significant differences in IOP values at baseline between the 2 groups .
RESULTS	IOP values after positioning in the prone position were significantly higher than those at baseline in both groups ( propofol group : from 8.93.5 to 21.95.0 mm Hg ; sevoflurane group : from 11.63.9 to 24.83.4 mm Hg ; P < 0.05 ) .
RESULTS	Although IOP values were higher in the sevoflurane group than in the propofol group , the differences in IOP values were not statistically significant .
CONCLUSIONS	The results indicated that the choice of anesthetic agent , sevoflurane or propofol , did not have significant effects on IOP changes during a relatively short interval of prone spine surgery .

###11575487
BACKGROUND	The authors tested whether clinicians make different decisions if they pursue information than if they receive the same information from the start .
METHODS	Three groups of clinicians participated ( N = 1206 ) : dialysis nurses ( n = 171 ) , practicing urologists ( n = 461 ) , and academic physicians ( n = 574 ) .
METHODS	Surveys were sent to each group containing medical scenarios formulated in 1 of 2 versions .
METHODS	The simple version of each scenario presented a choice between 2 options .
METHODS	The search version presented the same choice but only after some information had been missing and subsequently obtained .
METHODS	The 2 versions otherwise contained identical data and were randomly assigned .
RESULTS	In one scenario involving a personal choice about kidney donation , more dialysis nurses were willing to donate when they first decided to be tested for compatibility and were found suitable than when theyknew they were suitable from the start ( 65 % vs. 44 % , P = 0.007 ) .
RESULTS	Similar discrepancies were found in decisions made by practicing urologists concerning surgery for a patient with prostate cancer and in decisions of academic physicians considering emergency management for a patient with acute chest pain .
CONCLUSIONS	The pursuit of information can increase its salience and cause clinicians to assign more importance to the information than if the same information was immediately available .
CONCLUSIONS	An awareness of this cognitive bias may lead to improved decision making in difficult medical situations .

###17589833
BACKGROUND	Few randomized , placebo-controlled trials have evaluated the comparative efficacy and tolerability of more than one pharmacological agent for panic disorder .
OBJECTIVE	The primary objective of this study was to compare the efficacy and tolerability of venlafaxine extended release ( ER ) with placebo in treating panic disorder .
OBJECTIVE	Secondary objectives included comparing paroxetine with venlafaxine ER and placebo .
METHODS	Outpatients aged > or = 18 years ( placebo , n = 157 ; venlafaxine ER 75 mg , n = 156 ; venlafaxine ER 225 mg , n = 160 ; paroxetine , n = 151 ) , with a primary diagnosis of panic disorder ( + / - agoraphobia ) based on the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) criteria for > or = 3 months were randomly assigned to receive venlafaxine ER ( titrated to 75 mg/day or 225 mg/day ) , paroxetine ( titrated to 40 mg/day ) , or placebo for 12 weeks .
METHODS	The primary efficacy measure was the percentage of patients free of full-symptom panic attacks ( > or = four symptoms ) at endpoint .
METHODS	Key secondary outcomes included the Panic Disorder Severity Scale ( PDSS ) mean score change and response .
RESULTS	At endpoint , all active treatment groups showed a significantly ( P < 0.01 ) greater proportion of patients free of full-symptom panic attacks , compared with placebo , and were superior ( P < 0.05 ) on most secondary measures .
RESULTS	The venlafaxine ER 225 mg group had significantly ( P < 0.05 ) greater mean PDSS score improvement than the paroxetine group ( -12.58 vs -11.87 ) and a significantly higher proportion of patients free of full symptom panic attacks ( 70.0 vs 58.3 % ) .
RESULTS	Both drugs were generally well tolerated .
CONCLUSIONS	Venlafaxine ER 75 mg/days and 225 mg/days and paroxetine 40 mg/day were both well tolerated and effective for short-term treatment of panic disorder .

###19301513
OBJECTIVE	The objective of two single-blind , three-treatment , crossover design , clinical studies was to evaluate the antiplaque efficacy using the Modified Gingival Margin Plaque Index ( MGMPI ) scores of three dentifrices : 1 ) a dentifrice containing 0.3 % triclosan/2 .0 % polyvinylmethyl ether/maleic acid ( PVM/MA ) copolymer/sodium fluoride in a 17 % dual silica base ( Colgate Total Advanced Toothpaste-Test Dentifrice ) ; 2 ) a commercially available dentifrice containing 0.3 % triclosan/2 .0 % PVM/MA copolymer/sodium fluoride in a 10 % high-cleaning silica base ( Colgate Total Toothpaste-Positive Control Dentifrice ) ; and 3 ) a commercially available dentifrice containing 0.243 % sodium fluoride in a regular silica base ( Colgate Winterfresh Gel-Negative Control Dentifrice ) .
METHODS	In each study , subjects reported to the clinical facility , and those who met the inclusion/exclusion criteria were given a complete oral prophylaxis , a soft-bristled toothbrush , and a commercially available dentifrice ( Colgate Cavity Protection Fluoride Toothpaste ) .
METHODS	They were instructed to use these products exclusively for seven days ( washout period ) , after which time they reported back to the clinical facility and were randomized into three treatment groups .
METHODS	All subjects then brushed their teeth for one minute with a full ribbon ( approximately 1.5 gm ) of Colgate Cavity Protection Fluoride Toothpaste , and immediately followed with a one-minute brushing using a full ribbon of one of the three study dentifrices .
METHODS	Subjects then rinsed with a red disclosing solution ( Butler Red-Cote ) and had their teeth and gums examined to assess their plaque content .
METHODS	They returned to the clinical facility after 24 hours of no oral hygiene to again have their teeth and gums examined to assess their plaque content .
METHODS	As per the crossover clinical design , the same methods and materials were used until all subjects used all three study treatments .
RESULTS	Seventeen subjects in the first study and 16 subjects in the second study complied with the protocol and completed all phases of the study .
RESULTS	Two-way ANOVA results from both studies showed that there was no difference in mean delta MGMPI scores between the groups using the Test Dentifrice and the Positive Control Dentifrice .
RESULTS	Results also showed that there was a statistically significant difference ( p < 0.05 ) in delta MGMPI scores between both the Test Dentifrice treatment and the Positive Control Dentifrice treatment when compared to the Negative Control Dentifrice .
CONCLUSIONS	A new improved dentifrice containing 0.2 % triclosan/3 .0 % PVM/MA copolymer/sodium fluoride in a 17 % dual silica base is comparable in controlling dental plaque when compared to a Positive Control Dentifrice containing 0.3 % triclosan/2 .0 % PVM/MA copolymer/sodium fluoride in a 10 % high-cleaning silica base , and is statistically significantly better in controlling dental plaque when compared to a Negative Control Dentifrice containing 0.243 % sodium fluoride in a silica base .

###17438216
BACKGROUND	In patients experiencing motor fluctuations , a major treatment challenge is the reduction of `` off '' time , particularly upon awakening .
BACKGROUND	Rotigotine ( Neupro ) is a novel dopaminergic agonist with 24-hour transdermal delivery .
METHODS	A randomized , double-blind , placebo-controlled trial ( PREFER Study ) was performed to assess efficacy and safety with two targeted transdermal doses of rotigotine in subjects with advanced Parkinson disease with > or = 2.5 hours of daily `` off '' time .
METHODS	Subjects were randomized to receive placebo patches ( n = 120 ) or rotigotine up to either 8 mg/24 hours ( n = 120 ) or 12 mg/24 hours ( n = 111 ) .
METHODS	The primary efficacy measures compared changes from baseline to the end of week 24 in the number of daily hours `` off '' and responder rates for subjects achieving > or = 30 % reduction in `` off '' time .
RESULTS	Compared to placebo , there were significant decreases in mean `` off '' time of 1.8 hours/day for the rotigotine 8 mg/24 hours group and 1.2 hours/day for the 12 mg/24 hours group .
RESULTS	For rotigotine 8 and 12 mg/24 hours groups , > or = 30 % responder rates were 56.6 % and 55.1 % compared to the 34.5 % placebo response .
RESULTS	`` On '' time without dyskinesia after awakening was more than doubled in both rotigotine treatment groups vs placebo .
RESULTS	Drug-related adverse effects included typical dopaminergic side effects , which were generally mild/moderate in intensity .
RESULTS	Patch application site reactions including erythema and pruritus were mild to moderate and transient in the majority of instances .
CONCLUSIONS	Transdermal rotigotine significantly improved `` off '' time in subjects with Parkinson disease not optimally controlled with levodopa and was safe and well tolerated , with typical dopaminergic side effects and occasional application site reactions .

###11465711
OBJECTIVE	Studies evaluating osteoarthritis treatment often use increased arthritis activity ( `` flare '' ) as a selection criterion , although no standardized assessments are available to quantify flare intensity and little is known about how this criterion affects treatment comparisons .
OBJECTIVE	This study evaluated the reliability of a flare assessment and how pretreatment flare intensity impacts conclusions on treatment efficacy .
METHODS	Using data from a double-blind , randomized , controlled trial ( n = 182 ) , we compared 3 osteoarthritis treatments with placebo in patients who met 3 of 4 flare criteria .
METHODS	The Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) questionnaire was used to document levels of pain , stiffness , and physical functioning at baseline and at the final visit .
METHODS	Following factor analytic evaluation , the flare items were standardized and summed to create a flare intensity index , which was used to identify patient subgroups .
METHODS	Analysis of covariance was applied to compare change in WOMAC scale scores from baseline to final visit for assessment of treatment differences among the flare intensity subgroups .
RESULTS	The flare indicators appeared unidimensional .
RESULTS	Analyses were stratified by tertiles of flare intensity .
RESULTS	Mean WOMAC scores improved in the patients receiving active treatment who were categorized into the 2 lowest flare intensity subgroups , but mean WOMAC scores improved in patients in all 4 treatment groups ( active and placebo ) in the most intense flare subgroup .
CONCLUSIONS	Patients with higher intensity flares may be more likely to report substantial improvement in functional status regardless of treatment .
CONCLUSIONS	Failure to account for flare intensity in analyses of data from pain trials with flare-based designs may inflate the risk of Type I and Type II errors in the interpretation of study results .

###12241778
BACKGROUND	Deltamethrin-impregnated dog collars reduce sandfly bite rates on dogs , and are effective in killing sandflies that attempt to feed .
BACKGROUND	Because domestic dogs are the principal reservoir hosts of zoonotic visceral leishmaniasis , we tested whether community-wide application of dog collars could protect children against infection with Leishmania infantum , the parasite that causes the disease .
METHODS	18 villages were paired , matched by preintervention child prevalence of L infantum infection .
METHODS	Within pairs , villages were randomly assigned to either control or intervention .
METHODS	All domestic dogs in intervention villages were provided with collars for the transmission season .
METHODS	The main outcome measure was incidence of L infantum infection after 1 year measured by seroconversion .
METHODS	Secondary outcomes were leishmanin skin test ( LST ) conversion and seroconversion in dogs .
RESULTS	The seroconversion rate in children was 1.49 % ( 17/1141 ) in the intervention villages and 2.41 % ( 26/1078 ) in control villages ( odds ratio 0.57 , 95 % CI 0.36-0 .90 , p = 0.017 ) .
RESULTS	LST conversion was also lowered , but not significantly ( odds ratio 0.66 , 0.41-1 .08 , p = 0.096 ) .
RESULTS	The seroconversion rate in dogs in intervention villages was also significantly reduced ( 0.46 , 0.30-0 .70 , p = 0.0003 ) .
CONCLUSIONS	Community-wide application of deltamethrin-impregnated dog collars not only protects domestic dogs from L infantum infections , but might also reduce the risk of L infantum infection in children .
CONCLUSIONS	These dog collars could have a role in control of visceral leishmaniasis and replace controversial dog culling programmes in some countries .
CONCLUSIONS	However , the effectiveness of dog collars will depend on the importance of wild versus domestic canids as reservoir hosts of L infantum .

###17974118
OBJECTIVE	To compare the efficacy of immediate nonocclusal loading ( test group ) versus early loading ( control group ) in partially edentulous patients .
METHODS	Fifty-two patients in 5 Italian private practices were randomized to 1 of the treatments : 25 to the immediately loaded group and 27 to the early loaded group .
METHODS	To be immediately loaded , single implants had to be inserted with a torque of > 30 Ncm , and splinted implants had to be inserted with a torque of > 20 Ncm .
METHODS	Implants in the immediately loaded group were provided with full acrylic resin nonoccluding temporary restorations within 48 hours after placement .
METHODS	After 2 months , full occluding provisional restorations were provided .
METHODS	Implants in the early loading group were not submerged and were loaded after 2 months .
METHODS	At 8 months , provisional restorations were replaced with definitive metal-ceramic prostheses .
METHODS	Outcome measures were prosthesis and implant failures as well as biologic and prosthetic complications recorded by nonblinded assessors .
METHODS	The Fisher exact test was used to compare the proportion of implant failures .
RESULTS	Fifty-two implants were placed in the immediately loaded group and 52 in the early loaded group .
RESULTS	No dropouts or complications occurred up to 14 months postinsertion .
RESULTS	One single implant failed in the immediately loaded group 2 months after placement .
RESULTS	There was no statistically difference for the tested outcome measures between the 2 procedures ( P > .99 ) .
CONCLUSIONS	The results of this randomized controlled clinical trial with 25 patients rehabilitated with immediately restored nonocclusally loaded implant-supported prostheses compared to 27 patients restored 2 months following placement suggest that there are no major clinical differences in implant survival between these 2 protocols .
CONCLUSIONS	No biologic or prosthetic complications occurred .

###8627205
BACKGROUND	This double-blind , randomized , parallel-group , placebo-controlled study investigated the efficacy and tolerability of fluticasone propionate aerosol ( 25 , 50 , or 100 mg bid for 12 weeks ) administered as primary maintenance therapy to patients whose mild to moderate asthma was inadequately controlled by as-needed use of an inhaled beta-agonist .
RESULTS	At all clinic visits , fluticasone propionate compared with placebo was associated with significant ( P < .05 ) improvement in pulmonary function indexed by forced expiratory volume in 1 second ( FEV1 ) as well as fewer night awakenings and less use of rescue albuterol .
RESULTS	Values for patient-measured morning peak expiratory flow rates ( PEFR ) were significantly ( P < .05 ) higher and the use of rescue albuterol was significantly ( P < .05 ) lower beginning 3 to 5 days after initiation of therapy in the groups treated with fluticasone propionate , compared with the placebo group .
RESULTS	Maximal improvement in FEV1 was achieved during the second week of treatment and maintained throughout the course of therapy .
RESULTS	Differences among the three fluticasone propionate dosing groups for these efficacy measures were not statistically significant .
RESULTS	The incidence of adverse events was similar across groups .
CONCLUSIONS	These data indicate that fluticasone propionate aerosol is an effective and well-tolerated treatment for asthma and significantly improves pulmonary function within days of initiation of treatment in patients whose asthma is inadequately controlled with as-needed beta-agonists .

###22761759
BACKGROUND	Since human immunodeficiency virus ( HIV ) - infected individuals are at increased risk of severe disease from pandemic influenza A ( H1N1pdm09 ) , vaccination was recommended as a prevention strategy .
BACKGROUND	The aim of the present study was to evaluate the safety , immunogenicity and persistence of the immune response after vaccination against pandemic influenza A ( H1N1pdm09 ) with an adjuvanted vaccine in human immunodeficiency virus ( HIV ) - infected adults using two single and two double doses .
RESULTS	Open label , randomized trial to evaluate the immune response following H1N1pdm09 vaccination in HIV-infected participants compared to HIV-negative controls ( NCT01155037 ) .
RESULTS	HIV-infected participants were randomized to receive 2 single ( 3.75 g hemagglutinin ) or 2 double ( 7.5 g hemagglutinin ) doses of the vaccine , 21 days apart .
RESULTS	Controls received one dose of the vaccine .
RESULTS	The primary endpoint was seroconversion as measured by hemagglutination inhibition assay .
RESULTS	Two hundred fifty six HIV-infected participants ( 129 and 127 randomized to single and double doses , respectively ) and 71 HIV-negative controls were enrolled .
RESULTS	Among HIV-infected participants , seroconversion increased from 46.7 % and 51.7 % after the first dose to 77.2 % and 83.8 % after the second dose of the vaccine using single and double doses , respectively .
RESULTS	Participants aged > 40 years showed higher seroconversion compared to younger participants .
RESULTS	Seroconversion among HIV-infected women and those with nadir CD4 < 200 cells/mm ( 3 ) was significantly higher with double doses .
RESULTS	Persistence of protective antibodies six months after vaccination was achieved by 80 % and 89.9 % of the HIV-infected participants who received single and double doses , respectively .
CONCLUSIONS	Our results support the recommendation of two double doses of adjuvanted H1N1pdm09 vaccine for HIV-infected individuals , particularly women , and those aged > 40 years or with nadir CD4 < 200 cells/mm ( 3 ) , to achieve antibody levels that are both higher and more sustained .
BACKGROUND	ClinicalTrials.gov NCT01155037 .

###9195520
OBJECTIVE	Although cyclosporin A ( CyA ) has been shown in a series of controlled trials to be of benefit to patients with rheumatoid arthritis ( RA ) , the majority of patients continue to require nonsteroidal antiinflammatory drugs ( NSAID ) for relief of joint pain and stiffness .
OBJECTIVE	Our aim was to determine whether there is a clinically important difference in calculated creatinine clearance when CyA is given concurrently with NSAID with high cyclooxygenase activity ( indomethacin and ketoprofen ) compared with sulindac , which has been claimed to have fewer renal effects than other NSAID , and compared with a simple analgesic , paracetamol .
METHODS	Patients with RA started 2.5 mg/kg CyA/day and dosage was increased cautiously to 5 mg/kg/day or less if the serum creatinine rose by > or = 30 % above baseline .
METHODS	The mean stabilized dose was 171.43 + / - 48.94 mg/day .
METHODS	Once CyA dose was stabilized , patients were allocated in random order to possible sequences of 4 week periods of acetaminophen , indomethacin , ketoprofen , and sulindac .
METHODS	Monitoring of cyclosporine levels , nephrotoxicity , and hepatoxicity , and adjustment of doses were by an `` unblinded '' clinician not in direct contact with study patients .
METHODS	All other assessments were made by a `` blinded '' clinician .
METHODS	Patients were instructed to take the identical appearing gelatin capsules qid .
METHODS	The multiple crossover design was analyzed using analysis of variance procedures for repeated measures .
RESULTS	35 patients were enrolled , of whom 32 patients completed the acetaminophen and at least one course of NSAID .
RESULTS	The calculated creatinine clearance was increased by 2.79 ml/min ( 3.5 % ) on average for acetaminophen versus all 3 NSAID ( 6 % for indomethacin , 2.3 % for ketoprofen , 2.6 % for sulindac ) .
RESULTS	The study had adequate power to detect a true difference of more than 10 % in mean creatinine clearance for each major comparison .
CONCLUSIONS	NSAID studied did not produce a clinically important difference in the calculated creatinine clearance in these patients-the difference with acetaminophen was modest and not of clinical significance .
CONCLUSIONS	There is no evidence that any of the 3 NSAID studied have an advantage or disadvantage .
CONCLUSIONS	It seems reasonable to allow patients to continue an NSAID of their or their clinician 's choice .

###17850566
BACKGROUND	Insertion of a gastric tube ( GT ) in anaesthetized , paralyzed and intubated patients may be difficult .
BACKGROUND	Tracheobronchial malposition of a GT may result in deleterious consequences .
BACKGROUND	The purpose of this study was to determine the reliability of tracheal cuff pressure measurement to detect endobronchial malposition of GTs .
BACKGROUND	We compared this new method with the measurement of exhaled CO ( 2 ) through the GT .
METHODS	Thirty patients under general anesthesia and orotracheal intubation were analysed .
METHODS	First , the cuff pressure of the low-volume endotracheal tube ( ET ; ID 7.0-8 .5 mm ) was increased to 40 cmH ( 2 ) O. Then , in a randomized fashion , the GT ( 18 Charrire ) was inserted consecutively into the trachea and oesophagus or vice versa .
METHODS	Cuff pressure was monitored continuously while advancing the GT .
METHODS	Furthermore , a capnograph was connected to the gastric tube and the aspirated PCO ( 2 ) was monitored .
RESULTS	Advancement of the gastric tube into the oesophagus increased ET cuff pressure by 1 + / - 1 cmH ( 2 ) O , while endotracheal placement of the GT increased cuff pressure by 28 + / - 8 cmH ( 2 ) O ( P < 0.001 ) .
RESULTS	Using an increase of > 10 cmH ( 2 ) O in cuff pressure detected endotracheal malpositioning of the GT with 100 % sensitivity and specificity .
RESULTS	In 28 out of 30 cases , PCO ( 2 ) increased by more than 2.6 kPa .
RESULTS	Thus , the PCO ( 2 ) approach failed to detect tracheal malpositioning in two cases resulting in a sensitivity of 93.3 % .
CONCLUSIONS	In intubated patients , cuff pressure measurement during insertion of a gastric tube is a new , simple and reliable bedside method to detect endotracheal malpositioning of a GT .

###25277215
BACKGROUND	Laparoscopic surgery might be beneficial for the patient , but it imposes increased physical and mental strain on the surgeon .
BACKGROUND	Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain .
BACKGROUND	This could reduce the risk of surgeon 's fatigue , mishaps and strain-induced illnesses , which may eventually improve the safety of laparoscopic surgical procedures .
METHODS	To test this hypothesis , a randomized study was performed , comparing both heart rate and heart rate variability ( HRV ) of the surgeon as a measure of total and mental strain , respectively , during conventional and robot-assisted laparoscopic cholecystectomy .
RESULTS	Both heart rate and HRV ( the low-frequency band/high-frequency band ratio ) were significantly decreased when using robotic assistance .
CONCLUSIONS	These data suggest the use of the daVinci Surgical System leads to less physical and mental strain of the surgeon during surgery .
CONCLUSIONS	However , assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon 's health .

###8730940
BACKGROUND	The findings from a controlled study of the effect of a public education campaign on community attitudes to mentally ill people are presented .
METHODS	A census of neighbours ' attitudes toward mental illness was conducted in two areas before the opening of supported houses for the mentally ill .
METHODS	In one area an educational campaign was conducted .
METHODS	The attitude survey was then repeated in both areas and patients ' social contact with neighbours was recorded .
RESULTS	Respondents exposed to the didactic component of the campaign showed only a small increase in knowledge about mental illness but there was a lessening of fearful and rejecting attitudes in the experimental area and not in the control area .
RESULTS	Neighbours in the experimental area were more likely to make social contact with both staff and patients .
RESULTS	It was social contact which was directly associated with improved attitudes rather than education per se .
RESULTS	Patients in the experimental area made contact and even friendships with neighbours whereas those in the control area did not .
CONCLUSIONS	The public education campaign did not lead to significant change in neighbours ' knowledge of mental illness .
CONCLUSIONS	However , their attitudes improved and patients ' social integration was enhanced .

###23510291
BACKGROUND	Rehabilitation interventions promote functional recovery among frail older adults and little is known about the clinical significance of physical outcome measure changes .
BACKGROUND	The purpose of our study is to examine the minimal clinically important difference ( MCID ) for the 6-minute walk distance ( 6MWD ) among frail Asian older adults .
METHODS	Data from the `` Evaluation of the Frails ' Fall Efficacy by Comparing Treatments '' study were analyzed .
METHODS	Distribution-based and anchor-based methods were used to estimate the MCID of the 6MWD .
METHODS	Participants who completed the trial rated their perceived change of overall health on the Global Rating of Change ( GROC ) scale .
METHODS	The receiver operating characteristic curve ( ROC ) was used to analyze the sensitivity and specificity of the cut-off values of 6MWD ( in meters ) for GROC rating of `` a little bit better '' ( +2 ) , based on feedback from participants .
RESULTS	The mean ( SD ) change in 6MWD was 37.3 ( 46.2 ) m among those who perceived a change ( GROC 2 ) , while those who did not was 9.3 ( 18.2 ) m post-intervention ( P = 0.011 ) .
RESULTS	From the anchor-based method , the MCID value for the 6MWD was 17.8 m ( sensitivity 56.7 % and specificity 83.3 % ) while distribution-based method estimated 12.9 m.
CONCLUSIONS	The MCID estimate for 6MWD was 17.8 m in the moderately frail Asian older adults with a fear of falling .
CONCLUSIONS	The results will aid the clinicians in goal setting for this patient population .

###22205241
BACKGROUND	The initial treatment of differentiated thyroid cancer is thyroidectomy , followed by remnant ablation with iodine-131 ( I-131 ) in some patients .
BACKGROUND	However , controversy exists concerning the appropriate radioiodine dose .
BACKGROUND	The aim of the study is to compare the success rate of low and high activities of I-131 for postoperative remnant ablation .
METHODS	A total of 108 nonmetastatic low-risk patients ( mean age : 46 , 85 % women ) with papillary and follicular carcinoma had I-131 ablation for the postoperative thyroid remnant .
METHODS	Fifty-three patients received a low dose ( L ) ( 800 MBq ) and 55 patients received a high dose ( H ) ( 3700 MBq ) of I-131 .
METHODS	After total thyroidectomy , thyroid bed I-131 uptake ( RAIU ) and neck ultrasonography ( USG ) were performed to determine the remnant volume and the iodine avidity , which were used to calculate the dose delivered to the remnant tissue .
METHODS	The success rate of I-131 ablation was assessed with four different criteria based on serum thyroglobulin ( Tg ) and USG with and without the utilization of I-131 diagnostic whole-body scintigraphy ( DxWBS ) .
METHODS	Ablation was considered to be successful if patients fulfilled all of the following criteria .
METHODS	( a ) Strict criteria based on three tests : ( i ) USG negative , ( ii ) no tracer uptake or less than twice the background activity in the thyroid bed on DxWBS and/or up to 0.2 % RAIU , and ( iii ) Tg < 0.2 ng/ml ; ( b ) lax criteria based on three tests : ( i ) USG negative , ( ii ) no tracer uptake or less than twice the background activity in the thyroid bed on DxWBS and/or 0.2 % RAIU , and ( iii ) Tg < 2 ng/ml ; ( c ) strict criteria based on two tests : ( i ) USG negative and ( ii ) Tg < 0.2 ng/ml ; ( d ) lax criteria based on two test : ( i ) USG negative and ( ii ) Tg < 2 ng/ml .
RESULTS	When three tests were used to define successful ablation , in group L , 32 out of 53 ( 60 % ) and 43 out of 53 ( 81 % ) patients were successfully treated versus 35 out of 55 ( 64 % ) and 42 out of 55 ( 76 % ) for group H on the basis of strict and lax criteria , respectively ( P = NS ) .
RESULTS	The differences were not statistically significant between the two groups when only two tests were used to define ablation success ( 62 vs. 69 % with strict and 89 vs. 87 % with lax criteria , respectively ) .
CONCLUSIONS	Our findings suggest that remnant thyroid tissue in patients with low-risk , well-differentiated thyroid cancer after total thyroidectomy can be ablated with 800 MBq of I-131 .
CONCLUSIONS	The success rate is not different from that obtained with 3700 MBq I-131 .

###25390455
BACKGROUND	Oxygen consumption may be impaired in critically ill patients .
OBJECTIVE	To evaluate the effect of intravenous thiamine on oxygen consumption ( [ Formula : see text ] o2 ) in critically ill patients .
METHODS	This was a small , exploratory open-label pilot study conducted in the intensive care units at a tertiary care medical center .
METHODS	Critically ill adults requiring mechanical ventilation were screened for enrollment .
METHODS	Oxygen consumption ( [ Formula : see text ] o2 ) and cardiac index ( CI ) were recorded continuously for 9 hours .
METHODS	After 3 hours of baseline data collection , 200 mg of intravenous thiamine was administered .
METHODS	The outcome was change in [ Formula : see text ] o2 after thiamine administration .
RESULTS	Twenty patients were enrolled and 3 were excluded because of incomplete [ Formula : see text ] o2 data , leaving 17 patients for analysis .
RESULTS	There was a trend toward increase in [ Formula : see text ] o2 after thiamine administration ( 16.3 ml/min , SE 8.5 ; P = 0.052 ) .
RESULTS	After preplanned adjustment for changes in CI in case of a delivery-dependent state in some patients ( with exclusion of one additional patient because of missing CI data ) , this became statistically significant ( 16.9 ml/min , SE 8.6 ; P = 0.047 ) .
RESULTS	In patients with average CI greater than our cohort 's mean value of 3 L/min/m ( 2 ) , [ Formula : see text ] o2 increased by 70.9 ml/min ( 16 ; P < 0.0001 ) after thiamine .
RESULTS	Thiamine had no effect in patients with reduced CI ( < 2.4 L/min/m ( 2 ) ) .
RESULTS	There was no association between initial thiamine level and change in [ Formula : see text ] o2 after thiamine administration .
CONCLUSIONS	The administration of a single dose of thiamine was associated with a trend toward increase in [ Formula : see text ] o2 in critically ill patients .
CONCLUSIONS	There was a significant increase in [ Formula : see text ] o2 in those patients with preserved or elevated CI .
CONCLUSIONS	Further study is needed to better characterize the role of thiamine in oxygen extraction .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01462279 ) .

###24007452
OBJECTIVE	The aim of the present study was to evaluate a mobile health ( mHealth ) based remote medication adherence measurement system ( mAMS ) in elderly patients with increased cardiovascular risk treated for diabetes , high cholesterol and hypertension .
OBJECTIVE	Cardiovascular risk was defined as the presence of at least two out of the three risk factors : type 2 diabetes , hypercholesterolaemia and hypertension .
METHODS	For treatment of diabetes , hypercholesterolaemia and hypertension , four predefined routinely used drugs were selected .
METHODS	Drug adherence was investigated in a controlled randomized doctor blinded study with crossover design .
METHODS	The mAMS was used to measure and improve objectively the adherence by means of closed-loop interactions .
RESULTS	The mean age of the 53 patients ( 30 female ) was 69.4 4.8 years .
RESULTS	A total of 1654 electronic blisters were handed out .
RESULTS	A statistically significant difference ( P = 0.04 ) between the monitoring and the control phase was observed for the diabetes medication only .
RESULTS	In a post-study questionnaire twenty-nine patients appreciated that their physician knew if and when they had taken their medications and 13 asked for more or automated communication with their physicians .
RESULTS	Only one subject withdrew from the study because of technical complexity .
CONCLUSIONS	The results indicate that mHealth based adherence management is feasible and well accepted by patients with increased cardiovascular risk .
CONCLUSIONS	It may help to increase adherence , even in patients with high baseline adherence and , subsequently , lead to improved control of indicators including blood pressure and cholesterol concentrations .
CONCLUSIONS	Electronic blisters can be used in a multi-medication regimen but need to be carefully designed for day-to-day application .

###9786811
BACKGROUND	It is unclear whether smoking affects the course of Graves ophthalmopathy and therapeutic outcomes .
OBJECTIVE	To observe smoking behavior in a randomized study of the effect of radioiodine therapy on ophthalmopathy and in a case series of patients with Graves ophthalmopathy receiving orbital radiation therapy and glucocorticoids .
METHODS	Randomized , single-blind study of smoking and mild ophthalmopathy after radioiodine therapy ( study 1 ) and a retrospective cohort study of the association between smoking and response of severe ophthalmopathy to treatment ( study 2 ) .
METHODS	University medical center .
METHODS	300 patients with mild ophthalmopathy ( study 1 ) and 150 patients with severe ophthalmopathy ( study 2 ) .
METHODS	In study 1 , patients received radioiodine alone or radioiodine and a 3-month course of oral prednisone ( initial dosage , 0.4 to 0.5 mg/kg of body weight per day ) .
METHODS	In study 2 , patients received high-dose oral prednisone for 6 months ( initial dosage , 80 to 100 mg/d ) and underwent orbital radiation therapy by linear accelerator ( cumulative dose , 20 Gy per eye over 2 weeks ) .
METHODS	Degree of ophthalmopathy was assessed by overall evaluation ( inflammatory changes , proptosis , extraocular muscle dysfunction , corneal involvement , and optic neuropathy ) .
RESULTS	In study 1 , ophthalmopathy progressed in 4 of 68 nonsmokers ( 5.9 % [ 95 % CI , 3 % to 9 % ] ) and 19 of 82 smokers ( 23.2 % [ CI , 13 % to 33 % ] ) who received radioiodine alone ( P = 0.007 ) .
RESULTS	Ophthalmopathy was alleviated in 37 of 58 nonsmokers ( 63.8 % [ CI , 51 % to 78 % ] ) and 13 of 87 smokers ( 14.9 % [ CI , 10 % to 26 % ] ) who received radioiodine plus prednisone ( P < 0.001 ) .
RESULTS	In study 2 , 61 of 65 nonsmokers ( 93.8 % [ CI , 90 % to 98 % ] ) and 58 of 85 smokers ( 68.2 % [ CI , 57 % to 78 % ] ) responded to treatment ( P < 0.001 ) .
CONCLUSIONS	Cigarette smoking increases the risk for progression of ophthalmopathy after radioiodine therapy and decreases the efficacy of orbital radiation therapy and glucocorticoid therapy .

###7908257
OBJECTIVE	To assess the antihyperglycemic activity of a new peripherally acting alpha 2-adrenergic receptor antagonist , SL 84.0418 in healthy volunteers
METHODS	This was a randomized , double-blind crossover study .
METHODS	The effects of 10 , 50 , and 100 mg SL 84.0418 on blood glucose , plasma insulin , C-peptide , glucagon , epinephrine , and norepinephrine were investigated in comparison with placebo and 5 mg glipizide before and after an oral glucose challenge ( 75 gm ) .
RESULTS	Peak blood glucose and area under the blood-glucose curve were dose-dependently reduced by SL 84.0418 ; the extent of this reduction was similar with 100 mg SL 84.0418 and glipizide .
RESULTS	Glipizide but not SL 84.0418 decreased nadir blood glucose .
RESULTS	Plasma insulin and C-peptide were increased by glipizide but not by SL 84.0418 .
RESULTS	Treatments did not modify plasma glucagon .
RESULTS	Plasma epinephrine increased during glipizide treatment and plasma norepinephrine increased during treatment with 50 and 100 mg SL 84.0418 .
RESULTS	Systolic and diastolic blood pressure were moderately enhanced by 50 and 100 mg SL 84.0418 .
RESULTS	Adverse effects reflecting alpha 2-adrenergic receptor blockade occurred more frequently with 100 mg SL 84.0418 .
RESULTS	The adverse effect profile of 50 mg SL 84.0418 was not different from that observed with glipizide .
CONCLUSIONS	The alpha 2-adrenergic receptor antagonist SL 84.0418 dose dependently reduced the increase in blood glucose after glucose load without modification of plasma insulin .
CONCLUSIONS	It may represent an alternative to sulfonylureas in the treatment of non-insulin-dependent diabetes mellitus .
CONCLUSIONS	Further studies are needed to assess its efficacy and tolerability in non-insulin-dependent patients .

###9280815
BACKGROUND	Low-molecular-weight heparin is known to be safe and effective for the initial treatment of patients with proximal deep-vein thrombosis .
BACKGROUND	However , its application to pulmonary embolism or previous episodes of thromboembolism has not been studied .
METHODS	We randomly assigned 1021 patients with symptomatic venous thromboembolism to fixed-dose , subcutaneous low-molecular-weight heparin ( reviparin sodium ) or adjusted-dose , intravenous unfractionated heparin .
METHODS	Oral anticoagulant therapy with a coumarin derivative was started concomitantly and continued for 12 weeks .
METHODS	Approximately one third of the patients had associated pulmonary embolism .
METHODS	The outcome events studied over the 12 weeks were symptomatic recurrent venous thromboembolism , major bleeding , and death .
METHODS	We sought to determine whether low-molecular-weight heparin is at least equivalent to unfractionated heparin in patients with venous thromboembolism .
RESULTS	Twenty-seven of the 510 patients assigned to low-molecular-weight heparin ( 5.3 percent ) had recurrent thromboembolic events , as compared with 25 of the 511 patients assigned to unfractionated heparin ( 4.9 percent ) .
RESULTS	The difference of 0.4 percentage point indicates that the two therapies have equivalent value according to our predetermined definition of equivalence .
RESULTS	Sixteen patients assigned to low-molecular-weight heparin ( 3.1 percent ) and 12 patients assigned to unfractionated heparin ( 2.3 percent ) had episodes of major bleeding ( P = 0.63 ) , and the mortality rates in the two groups were 7.1 percent and 7.6 percent , respectively ( P = 0.89 ) .
CONCLUSIONS	Fixed-dose , subcutaneous low-molecular-weight heparin is as effective and safe as adjusted-dose , intravenous unfractionated heparin for the initial management of venous thromboembolism , regardless of whether the patient has pulmonary embolism or a history of venous thromboembolism .

###11958408
OBJECTIVE	To evaluate the clinical outcome of implants placed into sites grafted with bioactive glass .
METHODS	Seventeen consecutively treated patients were referred to a private specialist surgical practice for the repair of dentoalveolar defects , and/or ridge maintenance at the site of extraction sockets , prior to implantation .
METHODS	Bioactive glass available in 1 of 2 forms was utilized as an alloplastic grafting material .
METHODS	Bone cores were trephined out at the time of implantation and processed and examined to evaluate the tissue response under the light microscope .
METHODS	Implant mobility , marginal bone levels , and soft tissue health were all evaluated over a 2 - to 3-year follow-up period to determine treatment success .
RESULTS	A total of 40 Astra Tech dental implants were placed .
RESULTS	The overall success rate at the end of the study was 88.6 % for implants that were in function for a mean period of 29.2 months ( 22 to 24 months ) .
RESULTS	One patient with 5 successful implants died at 18 months after functional loading .
RESULTS	At that time the cumulative success rate was 90 % .
RESULTS	Another patient who was diagnosed with cancer of the large bowel lost 3 implants .
RESULTS	If this patient were excluded from the data , the cumulative success rate increases to 96.8 % .
RESULTS	Mean marginal bone loss measured 0.5 mm mesially and 0.4 mm distally over a maximum follow-up of 36 months .
RESULTS	Human histology demonstrated that connective tissue was seen to exist without any inflammatory response , for up to 6 months .
RESULTS	Increasing evidence of bone formation was seen in direct relation to the bioactive glass material beyond this time frame .
CONCLUSIONS	The need to repair and augment dentoalveolar defects necessitates the use of autogenous bone or a substitute that may be seen to avoid the additional morbidity of a donor site procedure and without risk of cross infection .
CONCLUSIONS	The use of bioactive glass has been proposed as a viable bone substitute .
CONCLUSIONS	The current study draws attention to the long healing time required to achieve even a small amount of new bone incorporation into the graft , as seen histologically .
CONCLUSIONS	However , the high rate of osseointegration and continued medium-term function of implants placed into these grafted sites would indicate that the use of bioactive glass does not prohibit osseointegration .
CONCLUSIONS	However , it is likely that the initial integration will have derived from those areas in contact with native bone .
CONCLUSIONS	Implants will survive for up to 3 years in sites grafted with bioactive glass , even when such grafts appear to only slowly conduct new bone growth .

###22809586
OBJECTIVE	Linear quadratic models predict that hypofractionation increases the biological effect of physical dose inhomogeneity .
OBJECTIVE	The clinical significance of this effect was tested retrospectively in a trial of adjuvant breast hypofractionation .
METHODS	The UK FAST trial randomised 915 women after breast conservation surgery between standard fractionation and two dose levels of a 5-fraction regimen delivering 5.7 or 6.0 Gy fractions in 5 weeks , using 3D dosimetry .
METHODS	Logistic regression tested for association between the absolute volumes receiving different isodose level > 100 % of prescribed dose ( hotspots ) and the risk of change in 2-year photographic breast appearance .
METHODS	The strength of this association was compared between control and hypofractionated groups .
RESULTS	Three hundred and ninety datasets from 11 participating centres were available for analysis .
RESULTS	At 2 years post-randomisation , 81 ( 20.8 % ) had mild change and 24 ( 6.2 % ) had marked change in photographic breast appearance .
RESULTS	After adjusting for breast size and surgical deficit , there was no statistically significant association between the risk of 2-year change in breast appearance and dose inhomogeneity in either the control or hypofractionated schedules , according to the various definitions of hotspots analysed .
RESULTS	The magnitude of the effect of dosimetry on 2-year change in breast appearance did not vary significantly between control and hypofractionated schedules for any of the dosimetry parameters ( p > 0.05 for all heterogeneity tests ) .
CONCLUSIONS	Dose inhomogeneity had no greater impact on the risk of 2-year change in photographic breast appearance after hypofractionated breast radiotherapy than after standard fractionation .

###12772546
OBJECTIVE	To assess the usefulness of three sources ( faith-based organizations ( FBOs ) , health system , and community ) for recruitment of African Americans with type 2 diabetes to a randomized controlled trial ( RCT ) .
METHODS	African Americans with type 2 diabetes were recruited to a diabetes self-management program at four FBO sites .
METHODS	An observational study of a multifaceted recruitment strategy to enroll subjects in the RCT that evaluated the effectiveness of a diabetes self-management program and the effect of recruitment source on retention after enrollment .
METHODS	Self-administered demographic surveys and weekly class attendance records were collected .
RESULTS	Of 184 interested individuals , 109 ( 59.2 % ) were enrolled .
RESULTS	Of those enrolled , 60.6 % recruited through the health system , 13.8 % FBOs , and 19.2 % the community .
RESULTS	The highest yield was achieved through the health system .
RESULTS	However , for both the intervention ( I ) and control ( C ) groups , respectively , participants recruited from FBOs ( 85.7 % I ; 62.5 % C ) were more likely to attend four or more sessions than those from the health system ( 75.0 % I ; 43.3 % C ) and community ( 55.6 % I ; 25.0 % C ) .
RESULTS	Despite similar class size , participants in the intervention group ( 74.5 % ; n = 41 ) were more likely to attend four or more of the seven classes than those in the delayed intervention ( control group ) ( 40.7 % ; n = 22 ) .
CONCLUSIONS	The findings suggest that African American adults with diabetes can be successfully recruited and retained in a racially targeted RCT conducted in FBOs .
CONCLUSIONS	Key elements to consider are the use of a multifaceted approach for participant recruitment , particularly the benefit of health system physician involvement in recruitment since the highest yield was achieved through health system providers , and importance of site location for retention .

###16960172
BACKGROUND	Vitamin A deficiency impairs iron metabolism ; vitamin A supplementation of vitamin A-deficient populations may reduce anemia .
BACKGROUND	The mechanism of these effects is unclear .
BACKGROUND	In vitro and in animal models , vitamin A treatment increases the production of erythropoietin ( EPO ) , a stimulant of erythropoiesis .
OBJECTIVE	We measured the effect of vitamin A supplementation on hemoglobin , iron status , and circulating EPO concentrations in children with poor iron and vitamin A status .
METHODS	In a double-blind , randomized trial , Moroccan schoolchildren ( n = 81 ) were given either vitamin A ( 200,000 IU ) or placebo at baseline and at 5 mo. .
METHODS	At baseline , 5 mo , and 10 mo , hemoglobin , indicators of iron and vitamin A status , and EPO were measured .
RESULTS	At baseline , 54 % of children were anemic ; 77 % had low vitamin A status .
RESULTS	In the vitamin A group at 10 mo , serum retinol improved significantly compared with the control group ( P < 0.02 ) .
RESULTS	Vitamin A treatment increased mean hemoglobin by 7 g/L ( P < 0.02 ) and reduced the prevalence of anemia from 54 % to 38 % ( P < 0.01 ) .
RESULTS	Vitamin A treatment increased mean corpuscular volume ( P < 0.001 ) and decreased serum transferrin receptor ( P < 0.001 ) , indicating improved iron-deficient erythropoiesis .
RESULTS	Vitamin A decreased serum ferritin ( P < 0.02 ) , suggesting mobilization of hepatic iron stores .
RESULTS	Calculated from the ratio of transferrin receptor to serum ferritin , overall body iron stores remained unchanged .
RESULTS	In the vitamin A group at 10 mo , we observed an increase in EPO ( P < 0.05 ) and a decrease in the slope of the regression line of log10 ( EPO ) on hemoglobin ( P < 0.01 ) .
CONCLUSIONS	In children deficient in vitamin A and iron , vitamin A supplementation mobilizes iron from existing stores to support increased erythropoiesis , an effect likely mediated by increases in circulating EPO .

###24393750
OBJECTIVE	To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors .
METHODS	A 12-week , randomized , controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors .
METHODS	Men and women were randomized to snacks ( n = 15 ) or raisins ( n = 31 ) .
METHODS	Outcome measures were performed at baseline , 4 , 8 , and 12 weeks .
RESULTS	Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks .
RESULTS	Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks ; changes with raisin intake were -13.1 mg/dL ( P = 0.003 vs baseline ; P = 0.03 vs snacks ) .
RESULTS	Eating raisins significantly decreased glycated hemoglobin ( HbA1c ) level ( -0.12 % ; P = 0.004 ) , a significantly greater level decrease than seen with snack intake ( P = 0.036 ) .
RESULTS	Snack intake did not significantly affect subject systolic or diastolic blood pressure ( BP ) .
RESULTS	Raisin intake was associated with reductions in systolic blood pressure ( SBP ) at 4 , 8 , and 12 weeks with mean changes of -6.0 to 10.2 mmHg ; all these changes were statistically significant ( P = 0.015 to 0.001 ) .
RESULTS	Raisins were associated with significantly greater changes in diastolic blood pressure ( DBP ) at 4 , 8 , and 12 weeks than snacks ( P < 0.05 ) .
RESULTS	Body weight did not significantly change within or between groups .
CONCLUSIONS	Regular consumption of raisins may reduce glycemia and cardiovascular risk factors , including BP rate .

###24481031
BACKGROUND	Endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) is superior to conventional transbronchial needle aspiration ( cTBNA ) in the staging of lung cancer .
BACKGROUND	However , its efficiency in diagnosis of sarcoidosis when combined with endobronchial biopsy ( EBB ) and transbronchial lung biopsy ( TBLB ) has not been studied .
BACKGROUND	This randomized controlled trial compares diagnostic yield of EBUS-TBNA vs cTBNA in combination with EBB and TBLB .
METHODS	Patients with clinical diagnosis of sarcoidosis were randomized 1:1 to EBUS-TBNA or cTBNA .
METHODS	All patients underwent TBLB and EBB .
METHODS	The primary outcome was detection of granulomas .
METHODS	The secondary end points were the individual and cumulative yields of various procedures , serious adverse events , and procedure time .
RESULTS	Of the 130 patients , sarcoidosis was diagnosed in 117 ( 62 cTBNA , 55 EBUS-TBNA ) .
RESULTS	The two groups were similar at baseline .
RESULTS	Granulomas were demonstrated in 104 ( 53 cTBNA , 51 EBUS-TBNA ) patients and were similar in two groups ( 85.5 % vs 92.7 % , P = .34 ) .
RESULTS	Individually , EBUS-TBNA had the highest yield ( 41 of 55 , 74.5 % ) , which was better than cTBNA ( 30 of 62 , 48.4 % , P = .004 ) or EBB ( 40 of 111 , 36.3 % , P < .0001 ) but not TBLB ( 78 of 112 , 69.6 % , P = .54 ) .
RESULTS	Adding EBB/TBLB to cTBNA led to an increase in granuloma detection , whereas the addition of TBLB ( but not EBB ) significantly enhanced the yield of EBUS-TBNA .
RESULTS	The procedure time was significantly longer with EBUS-TBNA .
RESULTS	No major adverse events occurred .
CONCLUSIONS	Individually , EBUS-TBNA has the highest diagnostic yield in sarcoidosis , but it should be combined with TBLB for the optimal yield .
CONCLUSIONS	The diagnostic yield of cTBNA ( plus EBB and TBLB ) is similar to EBUS-TBNA plus TBLB .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01908868 ; URL : www.clinicaltrials.gov .

###15446780
OBJECTIVE	To select and evaluate characteristics of primary care practice groups relevant for stratification prior to randomization .
METHODS	Structured telephone interviews and pre - and post-intervention prescription data .
METHODS	Additional study in an RCT to rationalize prescribing in primary care , addressing groups of pharmacists and doctors .
METHODS	Representatives of 61 primary care practice groups in the Netherlands .
METHODS	Identification and evaluation of primary care practice group characteristics related to changes in prescribing .
METHODS	These characteristics were evaluated by estimation of incidence rate ratios ( Poisson regression ) .
RESULTS	Of practice groups 40 representatives ( 66 % ) participated in our study .
RESULTS	Three characteristics were found to be most relevant for stratification : the purpose of the practice groups ( whether they participated in information exchange ( n = 14 ) or binding consensus on pharmacotherapy ( n = 26 ) ) , the use of a formulary ( 22 practice groups did and 18 groups did not ) and the use of feedback data ( 22 groups did and 18 groups did not ) .
RESULTS	These characteristics strongly modified the effect of the program on prescribing behaviour .
RESULTS	While the overall effect of the program was to significantly reduce the prescribing of the targeted drugs , this change was not consistent in all strata .
CONCLUSIONS	Assessment of the characteristics of practice groups made it possible to define factors to be used for a stratified randomization of practice groups which in retrospect indeed modified the effect of an educational intervention directed to change prescribing .
CONCLUSIONS	Such pre-randomization assessments can be a useful tool in interventions designed to improve practice patterns in groups of physicians .

###24321091
BACKGROUND	Eventual control of HIV/AIDS is believed to be ultimately dependent on a safe , effective and affordable vaccine .
BACKGROUND	Participation of sub-Saharan Africa in the conduct of HIV trials is crucial as this region still experiences high HIV incidences .
BACKGROUND	We describe the experience of recruiting and retaining volunteers in the first HIV vaccine trial ( HIVIS03 ) in Tanzania .
METHODS	In this trial enrolled volunteers from amongst Police Officers ( POs ) in Dar es Salaam were primed with HIV-1 DNA vaccine at months 0 , 1 and 3 ; and boosted with HIV-1 MVA vaccine at months 9 and 21 .
METHODS	A stepwise education provision/sensitization approach was employed to eventual recruitment .
METHODS	Having identified a `` core '' group of POs keen on HIV prevention activities , those interested to participate in the vaccine trial were invited for a first screening session that comprised of provision of detailed study information and medical evaluation .
METHODS	In the second screening session results of the initial assessment were provided and those eligible were assessed for willingness to participate ( WTP ) .
METHODS	Those willing were consented and eventually randomized into the trial having met the eligibility criteria .
METHODS	Voluntary participation was emphasized throughout .
RESULTS	Out of 408 POs who formed the core group , 364 ( 89.0 % ) attended the educational sessions .
RESULTS	263 out of 364 ( 72.2 % ) indicated willingness to participate in the HIV vaccine trial .
RESULTS	98 % of those indicating WTP attended the pre-screening workshops .
RESULTS	220 ( 85.0 % ) indicated willingness to undergo first screening and 177 POs attended for initial screenings , of whom 162 ( 91.5 % ) underwent both clinical and laboratory screenings .
RESULTS	119 volunteers ( 73.5 % ) were eligible for the study .
RESULTS	79 were randomized into the trial , while 19 did not turn up , the major reason being partner/family advice .
RESULTS	60 volunteers including 15 females were recruited during a one-year period .
RESULTS	All participated in the planned progress updates workshops .
RESULTS	Retention into the schedule was : 98 % for the 3 DNA/placebo vaccinations , while it was 83 % and 73 % for the first and second MVA/placebo vaccinations respectively .
CONCLUSIONS	In this first HIV vaccine trial in Tanzania , we successfully recruited the volunteers and there was no significant loss to follow up .
CONCLUSIONS	Close contact and updates on study progress facilitated the observed retention rates .
BACKGROUND	ISRCTN90053831 ISRNCT01132976 and ATMR2009040001075080 .

###17929555
OBJECTIVE	To study the effects of the co-administration of growth hormone ( GH ) and aspirin to women with suboptimal response to GnRHa/FSH hyperstimulation protocol during in vitro fertilization and embryo transfer ( IVF-ET ) cycles .
METHODS	Forty cases of poor ovarian response in previous IVF-ET cycles were randomly divided into 2 groups : the studied group of GH and aspirin ( n = 20 ) , and the control group without GH or aspirin ( n = 20 ) .
RESULTS	The co-administration of GH and aspirin significantly increased the rates of retrieved oocytes ( P < 0.01 ) , promoted the maturation of oocytes ( P < 0.01 ) and improve the fertilization rates ( P < 0.05 ) .
RESULTS	However , there were no statistically differences between the two groups in the number of replaced embryos ( P > 0.05 ) and the pregnancy rate ( P > 0.05 ) .
CONCLUSIONS	The co-administration of GH and aspirin to poor ovarian responders is effective to increase the rates of retrieved oocytes , promote the maturation of oocytes and improve the fertilization rate in IVF-ET .

###20969664
BACKGROUND	Facial appearance has profound influence on the first impression that is projected to others .
OBJECTIVE	To determine the effects that complete correction of the nasolabial folds ( NLFs ) with hyaluronic acid ( HA ) filler has on the first impression one makes .
METHODS	Twenty-two subjects received injections of HA filler into the NLFs .
METHODS	Photographs of the face in a relaxed pose were taken at baseline , optimal correction visit , and 4 weeks after optimal correction .
METHODS	Three hundred four blinded evaluators completed a survey rating first impression on various measures of success for each photo .
METHODS	In total , 5,776 first impressions were recorded , totaling 46,208 individual assessments of first impression .
RESULTS	Our findings indicate a significant improvement in mean first impression in the categories of dating success , attractiveness , financial success , relationship success , athletic success , and overall first impression at the optimal correction visit .
RESULTS	At 4 weeks after the optimal correction visit , significance was observed in all categories measured : social skills , academic performance , dating success , occupational success , attractiveness , financial success , relationship success , athletic success , and overall first impression .
CONCLUSIONS	Full correction of the NLFs with HA filler significantly and positively influences the first impression an individual projects .

###12154207
OBJECTIVE	A primary therapeutic goal in rheumatoid arthritis ( RA ) is to reduce functional disability .
OBJECTIVE	The recent introduction of several new drugs for RA creates a need for readily assessing the effectiveness of therapy .
OBJECTIVE	Because the consistent use of disease-modifying anti-rheumatic drugs ( DMARDs ) reduces long-term disability , we analysed the large database of 1817 RA patients from leflunomide trials to assess if changes in the Health Assessment Questionnaire ( HAQ ) can measure the effectiveness of RA therapy .
METHODS	Data from three randomized double-blind RA trials were evaluated .
METHODS	The patients had received 100 mg leflunomide ( then 20 mg/day in 807 cases ) , methotrexate ( 15-20 mg/day in 669 cases ) , sulphasalazine ( 2 g/day in 132 cases ) and placebo ( in 209 cases ) .
METHODS	HAQ scores and outcomes were assessed using the American College of Rheumatology core data set .
METHODS	Detailed statistical analyses were made of changes in outcome variables at 1 and 6 months , changes in HAQ scores at 1-12 months , and effect sizes for outcome variables at 6 and 12 months .
METHODS	Multiple regression models of changes in HAQ scores were evaluated using backwards stepwise linear regression .
RESULTS	Mean HAQ scores declined progressively with treatment with all three DMARDs .
RESULTS	Changes occurred rapidly , and at month 1 were most pronounced with leflunomide .
RESULTS	HAQ scores correlated closely with clinical response , as seen in changes in non-responders and ACR 20 % and 50 % responders .
RESULTS	Regression analysis indicated that pain intensity and global assessments were significant determinants of HAQ .
CONCLUSIONS	HAQ scores are sensitive measures of effective DMARD therapy .
CONCLUSIONS	HAQ may be especially useful early in the treatment process to assess patients ' responses to DMARDs that show rapid onset of action , such as leflunomide .

###12576806
OBJECTIVE	Internal stenting is an integral part of endopyelotomy .
OBJECTIVE	Studies in animals show good healing after 1 to 2 weeks of ureterotomy .
OBJECTIVE	Inherent stent related problems warrant a minimum possible duration of stenting without compromising the results of endopyelotomy .
OBJECTIVE	We performed a prospective randomized trial to evaluate the optimum duration of stenting after endopyelotomy .
METHODS	A total of 57 consecutive patients with primary ureteropelvic junction obstruction were randomized to undergo 7/14Fr internal endopyelotomy stent placement for 2 ( group 1 ) and 4 ( group 2 ) weeks .
METHODS	A symptom based questionnaire was administered to all patients at stent removal .
METHODS	Followup was done with diuretic scanning at 3 , 6 , 9 and 12 months and then yearly , and thereafter with diuretic renography .
RESULTS	In each group 26 patients were available for evaluation .
RESULTS	The 2 groups were comparable in terms of age , sex , symptoms and ipsilateral glomerular filtration rate .
RESULTS	Mean followup was 22.3 ( range 12 to 36 ) and 21.3 months ( range 12 to 35 ) in groups 1 and 2 , respectively .
RESULTS	At the end of 1 year 24 group 1 ( 92.3 % ) and 23 group 2 ( 90.3 % ) patients had an improved drainage pattern .
RESULTS	This difference was not significant .
RESULTS	Stent related symptoms were present in a good proportion of patients in groups 1 and 2 but there was a significant difference in the incidence of urinary tract infections ( 11.5 % versus 38.1 % , p = 0.04 ) .
RESULTS	Of the group 2 patients 64 % preferred 2 weeks of stenting .
CONCLUSIONS	Two weeks seems to be a sufficient duration to allow functional restoration across the ureteropelvic junction after endopyelotomy and decrease stent related complications .

###12501880
BACKGROUND	Alendronate , an oral bisphosphonate , is available for the treatment of osteoporosis in a 70-mg once-weekly and a 10-mg once-daily formulation .
OBJECTIVE	This study aimed to determine patient preference for once-weekly versus once-daily dosing with alendronate , and to determine which treatment regimen the patients believed was more convenient and would be easier to comply with for a long period .
METHODS	This was a multicenter , randomized , open-label , preference study in which postmenopausal women with osteoporosis were enrolled to receive 9 weeks of treatment in crossover fashion ( 4 weeks with each study regimen separated by a 1-week washout period ) .
METHODS	The study regimens included once-weekly alendronate 70 mg and once-daily alendronate 10 mg .
METHODS	The primary and secondary end points were assessed with a questionnaire completed by the patient .
METHODS	Adverse events ( AEs ) were recorded to assess patient tolerability of the study medications .
RESULTS	A total of 324 patients met the eligibility requirements ; 288 were randomized to treatment , 287 ( mean age , 64.8 years ) received treatment , 272 completed the questionnaire , and 266 completed the study .
RESULTS	Of the patients who completed the questionnaire , 235 patients preferred the 70-mg once-weekly dosing regimen compared with the 10-mg once-daily regimen ( 86.4 % vs 9.2 % ; P < 0.001 ) .
RESULTS	Most patients also believed that once-weekly dosing was more convenient than once-daily dosing ( 89.0 % vs 7.7 % ; P < 0.001 ) and would allow them to achieve better long-term compliance ( 87.5 % vs 8.5 % ; P < 0.001 ) .
RESULTS	Clinical AEs were reported in 30.7 % of patients treated with once-weekly alendronate and 30 % of patients treated with once-daily alendronate , with no significant differences between treatments .
CONCLUSIONS	When once-weekly alendronate 70 mg was compared with once-daily alendronate 10 mg in this study , 70-mg once-weekly alendronate was the preferred dosing regimen .

###18840641
BACKGROUND	Bone strength and fracture resistance are determined by bone mineral density ( BMD ) and structural , mechanical , and geometric properties of bone .
BACKGROUND	DESIGN , SETTING , AND OBJECTIVES : This randomized , double-blind , placebo-controlled outpatient study evaluated effects of once-monthly oral ibandronate on hip and lumbar spine BMD and calculated strength using quantitative computed tomography ( QCT ) with finite element analysis ( FEA ) and dual-energy x-ray absorptiometry ( DXA ) with hip structural analysis ( HSA ) .
METHODS	Participants were women aged 55-80 yr with BMD T-scores -2.0 or less to -5.0 or greater ( n = 93 ) .
METHODS	Oral ibandronate 150 mg/month ( n = 47 ) or placebo ( n = 46 ) was administered for 12 months .
METHODS	The primary end point was total hip QCT BMD change from baseline ; secondary end points included other QCT BMD sites , FEA , DXA , areal BMD , and HSA .
METHODS	All analyses were exploratory , with post hoc P values .
RESULTS	Ibandronate increased integral total hip QCT BMD and DXA areal BMD more than placebo at 12 months ( treatment differences : 2.2 % , P = 0.005 ; 2.0 % , P = 0.003 ) .
RESULTS	FEA-derived hip strength to density ratio and femoral , peripheral , and trabecular strength increased with ibandronate vs. placebo ( treatment differences : 4.1 % , P < 0.001 ; 5.9 % , P < 0.001 ; 2.5 % , P = 0.011 ; 3.5 % , P = 0.003 , respectively ) .
RESULTS	Ibandronate improved vertebral , peripheral , and trabecular strength and anteroposterior bending stiffness vs. placebo [ 7.1 % ( P < 0.001 ) , 7.8 % ( P < 0.001 ) , 5.6 % ( P = 0.023 ) , and 6.3 % ( P < 0.001 ) , respectively ] .
RESULTS	HSA-estimated femoral narrow neck cross-sectional area and moment of inertia and outer diameter increased with ibandronate vs. placebo ( respectively 3.6 % , P = 0.003 ; 4.0 % , P = 0.052 ; 2.2 % , P = 0.049 ) .
CONCLUSIONS	Once-monthly oral Ibandronate for 12 months improved hip and spine BMD measured by QCT and DXA and strength estimated by FEA of QCT scans .

###15555343
OBJECTIVE	To study the clinical safety and effect on local recurrence in unresectable small hepatocellular carcinoma treated by radiofrequency ablation ( RFA ) with and without chemotherapy through a prospective randomized trial .
METHODS	Thirty-eight unresectable small hepatocellular carcinoma patients with diameter < / = 3 cm were selected , of which 27 patients have been followed up for 1 year .
METHODS	Through a prospective randomized trial , 12 patients were in the RFA group and 15 patients in the RFA combined with systemic chemotherapy group .
METHODS	RFA was given image-guided .
METHODS	The regimen of systemic chemotherapy : EADM 50 mg on day 1 , 3 ; CDDP 40 mg on day 1 , 3 and FUDR 500 mg on day 1 , 2 , 3 .
METHODS	After RFA treatment , liver function , WBC count and complications were observed on day 1 , 4 , 7 ; CT scan was performed in 1 , 6 , 12 months .
METHODS	The safety and local recurrence were analyzed .
RESULTS	There was no local recurrence of the tumor in the two groups 1 month after RFA treatment .
RESULTS	The 6 - and 12-month local recurrence rates were significantly lower in the combined group than that in RFA group alone ( P < 0.01 ) .
RESULTS	There were no severe complications in the two groups , and nor was there any significant difference in liver function and WBC count .
CONCLUSIONS	RFA combined with systemic chemotherapy is safe , and it can reduce the local recurrence of unresectable small hepatocellular carcinoma < / = 3 cm in diameter .

###20926533
BACKGROUND	Metformin is widely prescribed to pregnant women with polycystic ovary syndrome ( PCOS ) in an attempt to reduce pregnancy complications .
BACKGROUND	Metformin is not approved for this indication , and evidence for this practice is lacking .
OBJECTIVE	Our objective was to test the hypothesis that metformin , from first trimester to delivery , reduces pregnancy complications in women with PCOS .
METHODS	We conducted a randomized , placebo-controlled , double-blind , multicenter study at 11 secondary care centers .
METHODS	The participants were 257 women with PCOS , in the first trimester of pregnancy , aged 18-42 yr .
METHODS	We randomly assigned 274 singleton pregnancies ( in 257 women ) to receive metformin or placebo , from first trimester to delivery .
METHODS	The prevalence of preeclampsia , gestational diabetes mellitus , preterm delivery , and a composite of these three outcomes is reported .
RESULTS	Preeclampsia prevalence was 7.4 % in the metformin group and 3.7 % in the placebo group ( 3.7 % ; 95 % CI , -1.7 -9.2 ) ( P = 0.18 ) .
RESULTS	Preterm delivery prevalence was 3.7 % in the metformin group and 8.2 % in the placebo group ( -4.4 % ; 95 % , CI , -10.1 -1.2 ) ( P = 0.12 ) .
RESULTS	Gestational diabetes mellitus prevalence was 17.6 % in the metformin group and 16.9 % in the placebo group ( 0.8 % ; 95 % CI , -8.6 -10.2 ) ( P = 0.87 ) .
RESULTS	The composite primary endpoint prevalence was 25.9 and 24.4 % , respectively ( 1.5 % ; 95 % CI , -8.9 -11.3 ) ( P = 0.78 ) .
RESULTS	Women in the metformin group gained less weight during pregnancy compared with those in the placebo group .
RESULTS	There was no difference in fetal birth weight between the groups .
CONCLUSIONS	Metformin treatment from first trimester to delivery did not reduce pregnancy complications in PCOS .

###10374198
BACKGROUND	The role of thrombolytic agents in the treatment of pulmonary thromboembolism ( PTE ) remains a controversial issue .
BACKGROUND	The objective of this study is to assess the efficacy and safety of thrombolytic therapy in the treatment of PTE by means of a meta-analysis of randomized controlled trials ( RCT ) .
METHODS	A bibliographic search of the main biomedical bibliographic databases was carried out and eight randomized controlled trials that fulfilled the inclusion criteria were found .
METHODS	Two blinded and independent evaluators assessed the quality of RCT according to Jadad scale , and selected the necessary data to fulfill the objective of this study .
RESULTS	The selected trials were heterogeneous regarding the type of thrombolytic agent , the administration schedule , and the efficacy measures used .
RESULTS	The methodological quality was 2 points in the Jadad scale as an average .
RESULTS	No statistically significant differences in mortality nor in risk of PTE relapse were found between the group of patients receiving thrombolytic agents and the group not receiving them .
RESULTS	Significant differences were found , however , between these two groups as regards the risk of bleeding events ( OR = 2.62 ; CI 95 % : 1.56-4 .38 ) .
CONCLUSIONS	The results of these meta-analyses do not suggest the use of thrombolytic therapy in PTE in everyday clinical practice since measurable risks overcome potential benefits .

###12911461
OBJECTIVE	The aim of our study was to determine the role of N-methyl-d-aspartate ( NMDA ) - mediated mechanisms in cortical excitability changes after limb amputation , and their possible relationship to phantom pain .
METHODS	Sixteen upper limb amputees who were suffering from chronic phantom pain received the NMDA-antagonist memantine or placebo for 3 weeks .
METHODS	Intracortical inhibition ( ICI ) and intracortical facilitation ( ICF ) were determined at baseline and on day 21 using transcranial magnetic stimulation .
METHODS	Simultaneously , phantom pain intensity was assessed .
RESULTS	Memantine reduced ICF and enhanced ICI to roughly the same extent as seen in healthy subjects in a previous study .
RESULTS	These changes were not correlated to the reduction of phantom pain .
CONCLUSIONS	We therefore conclude that NMDA-mediated mechanisms influence changes of ICI and ICF occurring after limb amputation .
CONCLUSIONS	However , our results suggest that these cortical excitability changes and phantom pain are independent of each other .

###25275368
BACKGROUND	Coordination between breathing and swallowing helps prevent aspiration of foreign material into the respiratory tract .
BACKGROUND	The authors examined the effects of anesthesia and hypercapnia on swallowing-breathing coordination .
METHODS	In a randomized controlled crossover study , general anesthesia with propofol or sevoflurane was titrated using an up-down method to identify the threshold for suppression of the motor response to electrical stimulation of the forearm .
METHODS	Additional measurements included bispectral index , genioglossus electromyogram , ventilation ( pneumotachometer ) , and hypopharyngeal pressure .
METHODS	During wakefulness and at each level of anesthesia , carbon dioxide was added to increase the end-tidal pressure by 4 and 8 mmHg .
METHODS	A swallow was defined as increased genioglossus activity with deglutition apnea and an increase in hypopharyngeal pressure .
METHODS	Spontaneous swallows were categorized as physiological ( during expiration or followed by expiration ) or pathological ( during inspiration or followed by an inspiration ) .
RESULTS	A total of 224 swallows were analyzed .
RESULTS	Anesthesia increased the proportion of pathological swallows ( 25.9 % vs. 4.9 % ) and decreased the number of swallows per hour ( 1.73.3 vs. 28.022.3 ) compared to wakefulness .
RESULTS	During anesthesia , hypercapnia decreased hypopharyngeal pressure during inspiration ( -14.13.7 vs. -8.72 mmHg ) and increased minute ventilation , the proportion of pathological swallows ( 19.1 % vs. 12.3 % ) , and the number of swallows per hour ( 5.517.0 .
RESULTS	vs. 1.35.5 ) .
CONCLUSIONS	Anesthesia impaired the coordination between swallowing and respiration .
CONCLUSIONS	Mild hypercapnia increased the frequency of swallowing during anesthesia and the likelihood of pathological swallowing .
CONCLUSIONS	During anesthesia , the risk for aspiration may be further increased when ventilatory drive is stimulated .

###21701060
BACKGROUND	Focal dystonia in musicians ( MD ) is a task-specific movement disorder with a loss of voluntary motor control during instrumental playing .
BACKGROUND	Defective inhibition on different levels of the central nervous system is involved in the pathophysiology .
BACKGROUND	Sensorimotor retraining is a therapeutic approach to MD and aims to establish non-dystonic movements .
BACKGROUND	Transcranial direct current stimulation ( tDCS ) modulates cortical excitability and alters motor performance .
BACKGROUND	In this study , tDCS of the motor cortex was expected to assist retraining at the instrument .
METHODS	Nine professional pianists suffering from MD were included in a placebo-controlled double-blinded study .
METHODS	Retraining consisted of slow , voluntarily controlled movements on the piano and was combined with tDCS .
METHODS	Patients were treated with three stimulation protocols : anodal tDCS , cathodal tDCS and placebo stimulation .
RESULTS	No beneficial effects of single-session tDCS-supported sensorimotor retraining on fine motor control in pianists with MD were found in all three conditions .
CONCLUSIONS	The main cause of the negative result of this study may be the short intervention time .
CONCLUSIONS	One retraining session with a duration of 20 min seems not sufficient to improve symptoms of MD. .
CONCLUSIONS	Additionally , a single tDCS session might not be sufficient to modify sensorimotor learning of a highly skilled task in musicians with dystonia .

###20346565
OBJECTIVE	Chlorhexidine ( CHX ) is an antimicrobial agent used in the prevention of tooth decay , periodontal disease , and postextraction alveolar osteitis ( AO ) .
OBJECTIVE	Recently , a bioadhesive gel to deliver the active substance , CHX , was introduced .
OBJECTIVE	The intra-alveolar placement of the bioadhesive gel allows a more direct and prolonged therapeutic effect of CHX , which is useful in the prevention of AO after extraction of impacted third molars .
OBJECTIVE	The intra-alveolar application of the bioadhesive CHX gel in patients with bleeding disorders may increase the risk of postoperative bleeding complications .
OBJECTIVE	Inversely , bleeding disorders might influence the efficacy of CHX for AO prevention .
OBJECTIVE	The purpose of the present study was to evaluate the effectiveness of the bioadhesive 0.2 % CHX gel in reducing the incidence of impacted third molar postextraction AO in patients with bleeding disorders .
METHODS	We performed a double-blind , randomized , parallel-group study of 38 patients with bleeding disorders .
METHODS	The experimental group ( n = 14 ) was treated with bioadhesive 0.2 % CHX gel applied intraoperatively once after surgical removal of the third molar .
METHODS	The control group ( n = 24 ) was treated in an identical fashion with placebo gel .
RESULTS	We observed a 57.15 % reduction in the incidence of AO in the experimental group .
RESULTS	The control group had a 17 % incidence of AO and the experimental group had a 7 % incidence of AO ( P = .402 ) .
RESULTS	Bleeding complications occurred in 21 % of the experimental group compared with 29 % of the control group ( P = .601 ) .
CONCLUSIONS	As described in previous studies , the single intra-alveolar application of the bioadhesive 0.2 % CHX gel in an intraoperative fashion seems to reduce the incidence of AO after removal of impacted third molars in patients with bleeding disorders .
CONCLUSIONS	On the basis of the reported percentage of bleeding complications , the routine use of postoperative local hemostatic measures is recommended .

###19690943
BACKGROUND	Recent studies have indicated that unmanaged pain , both acute and chronic , can affect mental status and might precipitate delirium , especially in elderly patients with hip fractures .
BACKGROUND	The aim of this study was to assess the effectiveness of fascia iliaca compartment block ( FICB ) for prevention of perioperative delirium in hip surgery patients who were at intermediate or high risk for this complication .
METHODS	On admission , all included patients were divided into three groups according to low , intermediate or high risk for perioperative delirium .
METHODS	Eligible patients ( those classified as at intermediate or high risk for developing delirium ) were sequentially randomly assigned to study treatment ( FICB prophylaxis or placebo ) according to a computer-generated randomization code .
METHODS	The primary outcome was perioperative delirium .
METHODS	Diagnosis of the syndrome was defined using the Diagnostic and Statistical Manual of Mental Disorders , 4th edition ( DSM-IV ) and Confusion Assessment Method ( CAM ) criteria .
METHODS	Secondary outcome variables were severity of delirium and delirium duration .
RESULTS	Delirium occurred in 33 ( 15.94 % ) out of 207 patients randomized to FICB prophylaxis or the placebo group .
RESULTS	Incidence of delirium in the FICB prophylaxis group was 10.78 % ( 11/102 ) , significantly different from the incidence ( 23.8 % , 25/105 ) in the placebo group [ relative risk 0.45 , 95 % confidence interval ( CI ) 0.23-0 .87 ] .
RESULTS	Nine of 17 patients with high risk for delirium and included in the FICB prophylaxis group developed delirium , whereas 10 of 16 high-risk patients included in the placebo group became delirious ( relative risk 0.84 , CI 0.47-1 .52 ) .
RESULTS	Two of 85 patients with intermediate risk for delirium and included in the FICB prophylaxis group developed delirium , whereas 15 of 89 intermediate-risk patients included in the placebo group became delirious ( relative risk 0.13 , CI 0.03-0 .53 ) .
RESULTS	Severity of delirium according to the highest value of the DRSR-98 during an episode with delirium in patients in the FICB prophylaxis group was on average 14.34 , versus 18.61 in the placebo group ( mean difference 4.27 , 95 % CI 1.8-5 .64 , P < 0.001 ) .
RESULTS	Mean duration of delirium in the FICB prophylaxis group was significantly shorter than in the placebo group ( FICB 5.22 days versus placebo 10.97 days , 95 % CI 3.87-7 .62 , P < 0.001 ) .
CONCLUSIONS	No significant difference was found among high-risk patients between FICB prophylaxis and placebo groups in terms of delirium incidence .
CONCLUSIONS	However , FICB prophylaxis significantly prevented delirium occurrence in intermediate-risk patients .
CONCLUSIONS	Thus FICB prophylaxis could be beneficial , particularly for intermediate-risk patients .

###19647623
OBJECTIVE	To determine if parenteral glutamine dipeptide supplementation given only in the preoperative period in malnourished patients after gastrointestinal surgery would sustain its effects into the first postoperative week , as shown by immune indices .
METHODS	A prospective randomized study on malnourished adult patients for abdominal surgery was done where one group ( n = 17 ) received preoperative glutamine supplementation ( 0.3 g .
METHODS	kg ( -1 ) x d ( -1 ) ) for 5 d and the other ( n = 17 ) had none .
METHODS	Both received isocaloric ( 30 kcal x kg ( -1 ) x d ( -1 ) ) and isonitrogenous ( 1.5 g x kg ( -1 ) x d ( -1 ) ) nutrition .
METHODS	Outcomes were 1 ) immune indices on admission ( day 1 ) , the day before surgery ( day 2 ) , and the seventh postoperative day ( day 3 ) ; and 2 ) clinical outcomes were infection , wound complication , days in the intensive care unit , and mortality .
METHODS	Statistical tests were repeated samples analysis of variance , Friedman 's test , Wilcoxon 's test , and t test for individual comparison .
RESULTS	The glutamine-supplemented group showed an increase in total white blood cells ( from 8700 on day to 11 080 on day 2 , P = 0.026 ) , granulocytes ( from 6177 on day 1 to 8568 on day 2 , P = 0.039 ) , and lymphocytes ( from 1516 on day 1 to 1747 on day 2 , P = 0.049 ) .
RESULTS	Significant decreases in glutamine-supplemented group values from day 2 to day 3 occurred in granulocytes , lymphocytes , and CD8 , CD22 , and CD19 cells .
RESULTS	Clinical outcome was similar in both groups .
RESULTS	Intake was adequate in both groups ( preoperative 85 % versus postoperative 82 % computed ) and the mean glutamine delivered was 18 g/d .
CONCLUSIONS	Parenteral glutamine supplementation in the preoperative period resulted in increased white blood cell , granulocyte , and lymphocyte counts , which was not sustained in the first week of the postoperative period , when supplementation was discontinued before surgery .

###24838369
BACKGROUND	Animal models suggest that neuroactive steroids contribute to alcohol 's acute effects .
BACKGROUND	We previously reported that a common nonsynonymous polymorphism , AKR1C3 2 in the gene encoding the enzyme 3-HSD2 / 17-HSD5 , and a synonymous single nucleotide polymorphism ( SNP ) , rs248793 , in SRD5A1 , which encodes 5-reductase , were associated with alcohol dependence ( AD ) .
OBJECTIVE	The aim of the study was to investigate whether these polymorphisms moderate subjective effects of alcohol in humans and whether AKR1C3 2 affects neuroactive steroid synthesis .
METHODS	Sixty-five Caucasian men ( 34 lighter and 31 heavier drinkers ; mean age 26.2 years ) participated in a double-blind laboratory study where they consumed drinks containing no ethanol or 0.8 g/kg of ethanol .
METHODS	Breath alcohol , heart rate ( HR ) , and self-reported alcohol effects were measured at 40-min intervals , and genotype was examined as a moderator of alcohol 's effects .
METHODS	Levels of the neuroactive steroid 5-androstane-3 ,17 - diol and its precursors , 3,5-androsterone and dihydrotestosterone , were measured at study entry using GC/MS .
RESULTS	Initially , carriers of the AD-protective AKR1C3 2G allele had higher levels of 5-androstane-3 ,17 - diol relative to the precursor 3,5-androsterone than C allele homozygotes .
RESULTS	AKR1C3 2G allele carriers exhibited greater increases in heart rate and stimulant and sedative effects of alcohol than C allele homozygotes .
RESULTS	The genotype effects on sedation were observed only in heavier drinkers .
RESULTS	The only effect of the SRD5A1 SNP was to moderate HR .
RESULTS	There were no interactive effects of the two SNPs .
CONCLUSIONS	The observed effects of variation in a gene encoding a neuroactive steroid biosynthetic enzyme on the rate of 17-reduction of androsterone relative to androstanediol and on alcohol 's sedative effects may help to explain the association of AKR1C3 2 with AD .

###25856791
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) generates a high burden on health care , and hospital admissions represent a substantial proportion of the overall costs of the disease .
BACKGROUND	Integrated care ( IC ) has shown efficacy to reduce hospitalisations in COPD patients at a pilot level .
BACKGROUND	Deployment strategies for IC services require assessment of effectiveness at the health care system level .
OBJECTIVE	The aim of this study was to explore the effectiveness of a community-based IC service in preventing hospitalisations and emergency department ( ED ) visits in stable frail COPD patients .
METHODS	From April to December 2005 , 155 frail community-dwelling COPD patients were randomly allocated either to IC ( n = 76 , age 73 ( 8 ) years , forced expiratory volume during the first second , FEV1 41 ( 19 ) % predicted ) or usual care ( n = 84 , age 75 ( 9 ) years , FEV1 44 ( 20 ) % predicted ) and followed up for 12 months .
METHODS	The IC intervention consisted of the following : ( a ) patient 's empowerment for self-management ; ( b ) an individualised care plan ; ( c ) access to a call centre ; and ( d ) coordination between the levels of care .
METHODS	Thereafter , hospital admissions , ED visits and mortality were monitored for 6 years .
RESULTS	IC enhanced self-management ( P = 0.02 ) , reduced anxiety-depression ( P = 0.001 ) and improved health-related quality of life ( P = 0.02 ) .
RESULTS	IC reduced both ED visits ( P = 0.02 ) and mortality ( P = 0.03 ) but not hospital admission .
RESULTS	No differences between the two groups were seen after 6 years .
CONCLUSIONS	The intervention improved clinical outcomes including survival and decreased the ED visits , but it did not reduce hospital admissions .
CONCLUSIONS	The study facilitated the identification of two key requirements for adoption of IC services in the community : appropriate risk stratification of patients , and preparation of the community-based work force .

###9850899
OBJECTIVE	To evaluate the pain produced during different phases of phacoemulsification cataract surgery using a scleral pocket incision under topical versus peribulbar anesthesia .
METHODS	Department of Ophthalmology , Oulu University Hospital , Oulu , Finland .
METHODS	This prospective study comprised 100 cataract patients who were randomly selected to have phacoemulsification with a scleral pocket incision using either topical or peribulbar anesthesia .
METHODS	Topical anesthesia comprised oxybuprocaine 0.4 % drops .
METHODS	Peribulbar anesthesia was given with an inferolateral transconjuctival injection of an even mixture of lidocaine 2 % and bupivacaine 0.5 % with hyaluronidase .
METHODS	Inadvertent eye movement during surgery was recorded .
METHODS	Pain occurring during intravenous line cannulation , introduction of the anesthetic agent , and phacoemulsification was measured using a visual analog scale ( from 0 to 10 ) and a descriptive verbal 5-step scale .
METHODS	Patients were asked about pain immediately after each phase .
RESULTS	The pain during cannulation was similar in both groups ( P = .498 ) .
RESULTS	The peribulbar injection was statistically significantly more painful than induction of topical anesthesia ( 2.11 and 0.10 , respectively ; P < .001 ) .
RESULTS	Surgery was statistically significantly more painful in the topical group than in the peribulbar group ( 2.76 and 0.85 , respectively ; P < .001 ) .
RESULTS	The mean pain score during all 3 phases was similar ( 1.43 topical group and 1.51 peribulbar group ; P = .500 ) .
RESULTS	On the verbal scale , surgery was more painful under topical than under peribulbar anesthesia ( P < .001 ) .
RESULTS	There were no statistical differences in pain during the peribulbar injection and during cannulation ( P = .461 and P = .462 , respectively ) .
RESULTS	Inadvertent eye movement occurred more often in the topical anesthesia group .
CONCLUSIONS	Considering the entire procedure , total pain using topical anesthesia was acceptable and equal to that using peribulbar anesthesia for phacoemulsification with a scleral pocket incision .
CONCLUSIONS	Pain during phacoemulsification was greater under topical anesthesia but not significantly different from the pain during the peribulbar injection .

###17069546
BACKGROUND	Early intervention in autism spectrum disorders ( ASDs ) appears promising and may represent a window of opportunity for more effective treatment .
BACKGROUND	Whereas the safety and efficacy of risperidone have been established for children aged 5 and older , they has not been adequately tested in preschool children .
METHODS	A randomized placebo-controlled study of risperidone in preschool children was conducted in a sample of young children , most of whom were also undergoing intensive behavioral treatment .
RESULTS	Preschool children tolerated low-dose risperidone well with no serious adverse effects observed over a 6-month treatment period .
RESULTS	Weight gain and hypersalivation were the most common side effects reported , and hyperprolactinemia without lactation or related signs was observed .
RESULTS	Significant differences between groups found at baseline complicated the analyses ; however , controlling for some of these differences revealed that preschoolers on risperidone demonstrated greater improvements in autism severity .
RESULTS	The change in autism severity scores from baseline to 6-month follow up for the risperidone group was 8 % compared to 3 % for the placebo group .
RESULTS	Notably , both groups significantly improved over the 6-month treatment period .
CONCLUSIONS	Study findings suggest that risperidone is well tolerated in preschoolers over a 6-month period , but that only minimally greater improvement in target symptoms was evident in the risperidone group , possibly due to the differences between groups at baseline or due to the small sample size .
CONCLUSIONS	Although these findings are not sufficient to direct treatment , they suggest that larger-scale , double-blind , placebo-controlled investigations of risperidone in preschoolers with ASDs should now be conducted .

###11310690
OBJECTIVE	To determine the safety and cost-effectiveness of replacing the intravenous ( IV ) tubing sets in hospitalized patients at 4 - to 7-day intervals instead of every 72 hours .
METHODS	Prospective , randomized study of infusion-related contamination associated with changing IV tubing sets within 3 days versus within 4 to 7 days of placement .
METHODS	A tertiary university cancer center .
METHODS	Cancer patients requiring IV infusion therapy were randomized to have the IV tubing sets replaced within 3 days ( 280 patients ) or within 4 to 7 days of placement ( 232 patients ) .
METHODS	Demographic , microbiological , and infusion-related data were collected for all participants .
METHODS	The main outcome measures were infusion - or catheter-related contamination or colonization of IV tubing , determined by quantitative cultures of the infusate , and infusion - or catheter-related bloodstream infection ( BSI ) , determined by quantitative culture of the infusate in association with blood cultures in febrile patients .
RESULTS	The two groups were comparable in terms of patient and catheter characteristics and the agents given through the IV tubing .
RESULTS	Intent-to-treat analysis demonstrated a higher level of tubing colonization in the 4 - to 7-day group versus the 3-day group ( median , 145 vs 50 colony-forming units ; P = .02 ) .
RESULTS	In addition , there were three episodes of possible infusion-related BSIs , all of which occurred in the 4 - to 7-day group ( P = .09 ) .
RESULTS	However , when the 84 patients who received total parenteral nutrition , blood transfusions , or interleukin-2 through the IV tubing were excluded , the two groups had a comparable rate of colonization ( 0.4 % vs 0.5 % ) , with no catheter - or infusion-related BSIs in either group .
CONCLUSIONS	In patients at low risk for infection from infusion - or catheter-related infection who are not receiving total parenteral nutrition , blood transfusions , or interleukin-2 , delaying the replacement of IV tubing up to 7 days may be safe , as well as cost-effective

###12649048
BACKGROUND	Recent screenings show a high prevalence of cardiovascular risk factors in the county of Stockholm .
BACKGROUND	Primary prevention may be a way to lower the risk burden of coronary heart disease , but we must establish that preventive programs are cost-effective .
METHODS	Through the use of a stochastic Markov model , which predicts reduction in coronary heart disease events based on risk factor reductions , this study evaluates the results of a previous controlled trial in middle-aged men comparing dietary advice , exercise , and the combination of both applied to an observed cohort of 60-year-old men in the county of Stockholm .
RESULTS	The model predicts lower costs and higher effectiveness for dietary advice compared to the alternatives .
RESULTS	Assuming a declining effect of the intervention , dietary advice saves 0.0228 life-years compared to no intervention .
RESULTS	If no decline is assumed , the corresponding figure is 0.0997 life-years .
RESULTS	From the societal perspective , the added costs are 2,892 Swedish Kronor ( SEK ) and 14,106 SEK for the two modeling assumptions , resulting in a cost-effectiveness of 127,065 SEK per life-year gained ( LYG ) and 141,555 SEK/LYG .
RESULTS	These figures are below what is generally thought of as cost-effective .
CONCLUSIONS	Based on the model , dietary advice appears to be the most cost-effective of the studied interventions .

###9389782
OBJECTIVE	To investigate changes in plasma lipid and lipoprotein levels induced by peroral oestrogen replacement and transdermal oestradiol gel therapy .
METHODS	The effects of peroral oestradiol valerate tablets ( 2 mg ) and placebo gel were compared with 1g transdermal oestradiol gel ( 1mg oestradiol ) and placebo tablets in a randomised , double-blind , double-dummy study for 6 months .
METHODS	Department of Internal Medicine , University of Oulu and Oulu Deaconess Institute , Oulu , Finland .
METHODS	Seventy-nine hysterectomised , postmenopausal women , 39 women in the peroral oestrogen group and 40 in the gel group .
METHODS	Cholesterol and triglycerides in total plasma and in various lipoprotein fractions , and sex hormones .
RESULTS	In the peroral oestrogen group total and LDL cholesterol were decreased and HDL cholesterol and triglycerides were increased .
RESULTS	In the oestradiol gel group plasma total , LDL and VLDL cholesterol and the ratio of LDL/HDL cholesterol were significantly decreased , but no change in HDL cholesterol and triglycerides was observed .
RESULTS	Overall the decrease in LDL levels was correlated with the increase in oestrogen levels .
CONCLUSIONS	Both peroral and transdermal replacement therapy had beneficial effects on plasma lipids by lowering total and LDL cholesterol and LDL/HDL cholesterol ratio .
CONCLUSIONS	These changes seem to be associated with changes in oestrogen levels .

###11199824
OBJECTIVE	The purpose of this study was to evaluate the results of two irradiated regions , the cervical and apical , for cervical dentin hypersensitivity treatment using pulsed a Nd : YAG laser with or without black ink .
BACKGROUND	There has been no reports on the irradiated area ( s ) except the cervical region for dentin hypersensitivity treatment using pulsed Nd : YAG laser .
METHODS	A total of 180 teeth diagnosed with cervical dentin hypersensitivity in 54 ( 39 females , 15 males , aged 21 to 73 ) healthy adult patients were included in this study , and teeth were randomly divided into four groups of 45 each .
METHODS	Sensitivity was rated using a blast from a fully depressed air syringe on a four-grade scale both before and up to 2 months after laser treatment .
METHODS	The effectiveness was evaluated on the change in the degree of hypersensitivity after laser treatment .
METHODS	The tooth surfaces in groups 1 and 2 were observed by the replica model method using scanning electron microscopy ( SEM ) .
RESULTS	The methods of irradiation at the cervical regions were better than those at the apical regions except for the period 2 months later .
RESULTS	The laser effect was enhanced by black ink at both areas .
RESULTS	The effective ( excellent and good ) rate was decreased depending on the time in every group .
RESULTS	SEM observation at the tooth surfaces from group 2 showed that dentinal tubules were occluded or narrowed after laser irradiation .
CONCLUSIONS	These results show that the method of irradiation by a pulsed Nd : YAG laser at cervical regions with black ink is the most effective for cervical dentin treatment of hypersensitivity and recurrence by this method is less than in other methods .

###19321052
OBJECTIVE	To investigate the necessity of modification to the traditional pigtail probe and evaluate its efficiency and therapeutic effect in searching the nasal cut ends and anastomosing the lacerated lacrimal canaliculus .
METHODS	Eighty-seven patients ( including 87 eyes ) suffering from canalicular laceration were randomized into two groups : 41 patients treated with traditional pigtail probes ( Group A ) and 46 with modified pigtail probes ( Group B ) .
METHODS	During the reconstruction of the lacerated canaliculi , the traditional pigtail probe and the modified pigtail probe were used respectively to seek for the nasal cut ends of lacerated lacrimal canaliculi .
METHODS	Peripherally inserted central catheter ( PICCTM ) silicone tube with diameter of 0.95 mm was intubated as a stent for 4-6 months .
METHODS	The surgical outcomes were retrospectively analyzed after stent removal .
RESULTS	In Group B , the primary success rate of searching the nasal cut ends of lacerated lacrimal canaliculi was 93.48 % ( 43/46 ) and the final success rate was 97.83 % ( 45/46 ) .
RESULTS	No false passage formed in Group B. Statistical significance was found between Group A and Group B as the primary success rates of searching the nasal cut ends ( X ( 2 ) equal to 10.522 , P less than 0.01 ) and the false passage forming rates were concerned ( X ( 2 ) ) equal to 4.704 , P less than 0.05 ) , whereas no significance was found between the two groups as the final success rates were concerned ( X ( 2 ) equal to 0.007 , P larger than 0.05 ) .
RESULTS	The mean time of searching the nasal cut ends of lacerated lacrimal canaliculi in Group B was ( 5.02 + / -0.73 ) minutes and the mean time of operation was ( 33.90 + / -4.84 ) minutes , and both were significantly shorter than those of Group A ( t ( 1 ) equal to 9.779 , t ( 2 ) equal to 10.700 , P less than 0.01 ) .
RESULTS	The cure rate of Group B was 95.65 % , though higher than that of Group A , no statistical significance was found ( Z equal to -0.007 , P larger than 0.05 ) .
RESULTS	Totally , 2 patients ( 2.30 % ) were found to be absent of common canaliculus and underwent bicanalicular nasal intubation in the two groups .
CONCLUSIONS	Pigtail probes are efficient and convenient apparatus for searching the nasal cut ends of the lacerated lacrimal canaliculi in the reconstruction of canalicular laceration .
CONCLUSIONS	Necessary or proper modifications to the pigtail probes can minimize the risk of iatrogenic damages or complications and enhance the efficiency and therapeutic effect of canalicular repair .

###25539757
BACKGROUND	Treatments of eating disorders result too often in partial psychological and physical remission , chronicization , dropout , relapse and death , with no fully known explanations for this failure .
BACKGROUND	In order to clarify this problem , we conducted three studies to identify the biochemical background of cognitive-behavioural psychotherapy ( CBT ) , individual psychology brief psychotherapy ( IBPP ) , and psychotherapy-pharmacotherapy with CBT + olanzapine in anorexics ( AN ) and bulimics ( BN ) by measuring the levels of plasma homovanillic acid ( HVA ) for dopamine secretion , plasma 3-methoxy-4-hydroxy-phenylglycol ( MHPG ) for noradrenalin secretion , and platelet [ 3H ] - Paroxetin-binding Bmax and Kd for serotonin transporter function .
BACKGROUND	The data were then compared with psychopathological and physical alterations .
METHODS	Study 1 investigated the effects of 4 months of CBT on plasma HVA , MHPG and [ 3H ] - Par-binding in 14 AN-restricted , 14 AN-bingeing/purging , and 22 BN inpatients .
METHODS	Study 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients .
METHODS	Study 3 investigated the effect of 3 months of CBT + olanzapine ( 5 mg/day ) in 30 AN outpatients .
METHODS	The data were analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters , two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups , Spearman 's test for the correlations between basal and final changes in the psychological and biological scores .
RESULTS	Study 1 revealed significant amelioration of the psychopathology in the AN and BN patients , no effects on HVA , MHPG or Paroxetin binding Kd , and a significant increase in Par-binding Bmax only in the BN patients .
RESULTS	Study 2 revealed a significant effect of IBPP on psychopathology in the AN and BN patients , and a significant increase in HVA only in the BN patients .
RESULTS	Study 3 revealed a significant positive effect of CBT + olanzapine therapy on the psychopathology and increased HVA values .
RESULTS	No correlations were observed in the 3 groups between biological and psychological effects of the three treatments .
CONCLUSIONS	Our data advance suggestions on the mechanism of action of the three therapies ; however , the lack of correlations between biochemical and psychological effects casts doubt on their significance .
CONCLUSIONS	Clinical Trials.gov .
CONCLUSIONS	Identifier NCT01990755 .

###8625237
BACKGROUND	The authors examined the relevance of S-phase fraction ( SPF ) and multidrug resistance ( MDR ) phenotype as predictive tests of breast cancer response in a series of patients treated by conventional doses of neoadjuvant chemotherapy with ( FAC ) or without ( FTC ) doxorubicin .
METHODS	Fine needle samplings of tumors were used to measure SPF by flow cytometry before treatment ( Day 0 ) , and to assess the MDR phenotype using semiquantified reverse transcriptase polymerase chain reaction and immunocytochemistry , before and after ( Days 8 and 28 ) the first cycle of chemotherapy .
RESULTS	Measurement of SPF before treatment was significantly associated with clinical response , but sequential assessment of MDR phenotype identified three groups of tumors with distinct outcomes : ( 1 ) tumors with a positive and constant expression of MDR1 , in which prediction of resistance was restricted to patients treated by FAC ; ( 2 ) tumors without any detectable expression , in which resistance to FAC or FTC treatments was rarely observed ; and ( 3 ) tumors with an early ( Day 8 ) acquired or increased MDR1 gene expression , which were always resistant to therapy to both treatment regimens .
RESULTS	These results were confirmed at the protein level .
CONCLUSIONS	Sequential assessment of MDR phenotype is a relevant tool for monitoring breast cancer response in neoadjuvant chemotherapy .

###16310895
OBJECTIVE	Peripheral intravenous nutrition ( PIVN ) delivered via a finebore midline offers a viable alternative to central venous feeding .
OBJECTIVE	The major complication is the onset of peripheral vein thrombophlebitis ( PVT ) .
OBJECTIVE	Feed additives such as heparin and hydrocortisone have been advocated in its prevention .
OBJECTIVE	Concern over the safety of heparin has prevented its widespread use ; this study examines its true benefit .
METHODS	A randomised , double-blind trial comparing the addition of either , Heparin 1500 units or hydrocortisone 15 mg or a combination of the two to full intravenous nutrition ( IVN ) ( 2500 ml , 13 g of nitrogen , 1190 m0sm/k ) was performed .
METHODS	All feeds were delivered via a finebore midline inserted via an antecubital fossa vein .
METHODS	Feeding was terminated in the event of complication or cessation of intended nutritional support .
RESULTS	One hundred and twenty-three episodes of feeding occurred in 110 patients .
RESULTS	The incidence of peripheral vein thrombosis was similar in each group ( Heparin 30 % ( 12/41 ) , hydrocortisone 33 % ( 14/42 ) , combination 31 % ( 13/41 ) chi ( 2 ) test P > 0.05 ) .
RESULTS	There was a significant difference in total catheter survival with the addition of heparin to the feeds , either alone ( 11 days ( SEM 1.79 ) or in combination with hydrocortisone ( 11.7 days ( SEM 1.39 ) compared with those receiving only hydrocortisone ( 6.9 days ( SEM 0.73 ) P = 0.002 and 0.030 , respectively ) ) .
CONCLUSIONS	When intravenous feeds are delivered in to a peripheral vein via a fine-bore midline , the addition of heparin to the feed extends the total period of feeding attainable .

###22894890
BACKGROUND	Anxiety and depression are the most commonly reported psychiatric conditions and frequently occur as comorbid disorders .
BACKGROUND	While the advent of conventional drug therapies has simplified treatment , a large segment of the population goes untreated or declines conventional therapy for financial , cultural , or personal reasons .
BACKGROUND	Therefore , the identification of inexpensive and effective alternative therapies for anxiety and depression is of relevance to public health .
OBJECTIVE	The current study explores data from a 2009 clinical chamomile trial in humans to determine if chamomile provides clinically meaningful antidepressant activity versus a placebo .
METHODS	In the 2009 randomized , double-blind , placebo-controlled study , the research team examined the antianxiety and antidepressant action of oral chamomile ( Matricaria recutita ) extract in participants with symptoms of comorbid anxiety and depression .
METHODS	In the 2009 study , all of participants ' evaluations took place at the Depression Research Unit at the University of Pennsylvania .
METHODS	The study drew participants from patients at the Department of Family Medicine and Community Health 's primary care clinic at the University of Pennsylvania , Philadelphia .
METHODS	Of the 57 participants in the 2009 trial , 19 had anxiety with comorbid depression ; 16 had anxiety with a past history of depression ; and 22 had anxiety with no current or past depression .
METHODS	The intervention and placebo groups in the 2009 trial received identically appearing 220-mg capsules containing either pharmaceutical-grade chamomile extract standardized to a content of 1.2 % apigenin or a placebo ( ie , lactose monohydrate NF ) , respectively .
METHODS	In the current study , the research team used generalized estimating equations analysis to identify clinically meaningful changes over time in scores from the Hamilton Depression Rating ( HAM-D ) questionnaire among treatment groups .
RESULTS	In the current study , the research team observed a significantly greater reduction over time in total HAM-D scores for chamomile vs placebo in all participants ( P < .05 ) .
RESULTS	The team also observed a clinically meaningful but nonsignificant trend for a greater reduction in total HAM-D scores for chamomile vs placebo in participants with current comorbid depression ( P = .062 ) .
RESULTS	When the team examined the HAM-D core mood item scores , it observed a significantly greater reduction over time for chamomile vs placebo in all participants ( P < .05 ) and a clinically meaningful but nonsignificant trend for a greater reduction over time for chamomile vs placebo in participants without current or past depression ( P = .06 ) .
CONCLUSIONS	Chamomile may provide clinically meaningful antidepressant activity that occurs in addition to its previously observed anxiolytic activity .

###20467616
OBJECTIVE	To evaluate the efficacy of 10 - to 16-mm-long implants inserted in maxillary sinuses augmented according to a lateral approach technique with 50 % particulated autogenous bone harvested from the oral cavity and 50 % Bio-Oss , versus 8-mm-long hydroxyapatite-coated implants placed in crestally augmented sinuses with autogenous bone according to the Cosci technique .
OBJECTIVE	All implants were early loaded at 45 days after placement .
METHODS	Forty partially or fully edentulous patients having 3 to 6 mm of residual crestal height and at least 4 mm thickness below the maxillary sinuses ( measured on a CT scan ) were randomised to receive one to three , 10 - to 16-mm-long implants ( 20 patients ) after lateral sinus lifting with 50 % anorganic bovine ( Bio-Oss ) and 50 % autogenous bone , or 8-mm-long implants ( 20 patients ) after crestal sinus lifting with autogenous bone .
METHODS	Implants were submerged and left to heal for 45 days .
METHODS	Within 1 week of abutment connection , implants were loaded with screw-retained full acrylic provisional prostheses .
METHODS	Definitive metal-ceramic prostheses were provisionally cemented 45 days after abutment connection .
METHODS	Outcome measures were the number of prosthesis and implant failures , and any complications .
METHODS	In addition , the stability of individual implants was assessed with Osstell and Periotest at abutment connection ( baseline ) and after 1 year of loading by a blinded outcome assessor .
METHODS	All patients were followed up for 1 year after loading .
RESULTS	No patient dropped out .
RESULTS	In three patients of the 8-mm implant group , primary stability could not be initially obtained .
RESULTS	However , after immediately replacing the unstable implants with implants with a larger diameter , sufficient primary stability was obtained .
RESULTS	One implant failed in the short implant group and five implants failed in three patients of the longer implant group .
RESULTS	The difference was not statistically significant .
RESULTS	There were no differences in complications between groups .
RESULTS	However , two major post-operative complications occurred in the longer implant group : one abscess and one sinusitis , which determined the complete failure of the treatment in two patients ( 4 implants lost ) .
RESULTS	Osstell values increased , whereas Periotest valves decreased over time , and there were no differences between groups at any time point .
CONCLUSIONS	This study suggests that in atrophic maxillary sinuses with a residual height of 3 to 6 mm , it may not be necessary to perform lateral sinus lifting to place longer implants ( 10 to 16 mm ) ; 8-mm short implants might be a preferable choice as the treatment appears to be associated with less morbidity .
CONCLUSIONS	This study also suggests that it is possible to load early ( at about 7 weeks ) implants placed in lifted sinuses that achieved a sufficient primary stability at placement .
CONCLUSIONS	These preliminary results must be confirmed by larger trials with follow-ups of 5 years or more to monitor the performance of short implants over time .

###9708589
OBJECTIVE	For contingent valuation to provide valid values for policy making , it is important that respondents be well informed about the goods they are asked to value .
OBJECTIVE	Few studies , however , have tested the impact of providing this information This study assessed the impact of risk information on patients ' willingness to pay for autologous blood donation and derived the willingness to pay in a sample of informed patients .
METHODS	Patients were randomized either to receive information about the risks of complications from allogeneic ( volunteer ) blood transfusions or to base their willingness to pay responses on their own prior knowledge .
METHODS	Four hundred twelve autologous blood donors were recruited from three study sites .
METHODS	Self-administered questionnaires collected information on willingness to pay , risk perceptions , and socioeconomic information .
RESULTS	As predicted by our theoretical model , providing risk information reduced the variance in the willingness to pay for autologous blood donation .
RESULTS	A tendency for information to reduce the willingness to pay was also found , suggesting that uninformed patients , on average , overestimate the risks of allogeneic blood transfusions .
RESULTS	The median willingness to pay in the informed sample was approximately $ 750 to $ 1,100 , depending on the estimation method , compared with $ 800 to $ 1,900 in the uninformed group .
RESULTS	Willingness to pay was significantly related to perceived transfusion risk , personal income , and dread of transfusions .
CONCLUSIONS	Our results are consistent with an economic model where individuals update their prior risk perceptions with new information .
CONCLUSIONS	The willingness to pay in the informed sample was far higher than the costs of autologous blood donation , suggesting that total benefits outweigh the costs of the procedure .

###22784703
BACKGROUND	For elementary school-children with aggressive behaviour problems , there is a strong need for effective preventive interventions to interrupt the developmental trajectory towards more serious behaviour problems .
OBJECTIVE	The aim of this RCT-study was to evaluate a school-based individual tailor-made intervention ( Stay Cool Kids ) , designed to reduce aggressive behaviour in selected children by enhancing cognitive behavioural skills .
METHODS	The sample consisted of 48 schools , with 264 fourth-grade children selected by their teachers because of elevated levels of externalizing behaviour ( TRF T-score > 60 ) , randomly assigned to the intervention or no-intervention control condition .
RESULTS	The intervention was found to be effective in reducing reactive and proactive aggressive behaviour as reported by children , mothers , fathers or teachers , with effect sizes ranging from .11 to .32 .
RESULTS	Clinically relevant changes in teacher-rated externalizing behaviour were found : the intervention reduced behaviour problems to ( sub ) clinical or normative levels for significantly more children than the control condition .
RESULTS	Some aspects of problems in social cognitive functioning were reduced and children showed more positive self-perception .
RESULTS	Ethnic background and gender moderated intervention effects on child and teacher reported aggression and child response generation .
CONCLUSIONS	The results of this study demonstrate the effectiveness on outcome behaviour and child cognitions of an individual tailor-made intervention across informants under real-world conditions .

###17711768
OBJECTIVE	Protoporphyrin IX ( PpIX ) is an endogenous photosensitizer commonly used in photodynamic therapy .
OBJECTIVE	This study sought to assess if PpIX fluorescence can be applied clinically to improve the delineation and excision of nonmelanotic cutaneous malignancies .
METHODS	Prospective , randomized control trial .
METHODS	A tertiary care skin cancer clinic .
METHODS	Fifty-one individuals with 65 cutaneous nonmelanotic cervicofacial malignancies were randomized into two groups .
METHODS	The control group was offered surgical excision with surgeon-delineated excision margins .
METHODS	The study group had their excision margins delineated while under fluorescence .
METHODS	The delineated lesion borders , proposed excision margins , and projected lesion-free areas were compared among the two groups .
METHODS	Pathologic resection margins and completeness of excision were also assessed .
RESULTS	Excisions performed using fluorescence delineation were 20 % narrower ( p < .01 ) and 17 % shorter ( p < .04 ) , with 35 % less lesion-free skin excised ( p < .005 ) .
RESULTS	All lesions excised using photodelineation had clear pathologic resection margins .
RESULTS	A significant number of lesions excised via the traditional approach required reexcision owing to pathologically positive peripheral margins ( p < .001 ) .
RESULTS	Follow-up at 2 years revealed no lesion recurrence among the study group and one recurrence within the control group .
CONCLUSIONS	The results demonstrate a reliable and novel application for photodynamic photodelination and support its application in the excision of nonmelanotic cutaneous malignancies .

###22512435
OBJECTIVE	High doses of short-term testosterone have been shown to acutely worsen sleep-disordered breathing in men with obstructive sleep apnoea ( OSA ) .
OBJECTIVE	The effects of lower , near-conventional doses of testosterone in obese men with OSA may differ over the longer term but have not been systematically studied .
OBJECTIVE	We assessed sleep and breathing effects of near-conventional testosterone treatment as an adjunct to weight loss in obese men with severe OSA .
METHODS	An 18-week randomized , double-blind , placebo-controlled , parallel group trial in 67 men .
METHODS	All subjects were placed on a hypocaloric diet and then received intramuscular injections of 1000 mg testosterone undecanoate or placebo at 0 , 6 and 12 weeks .
RESULTS	Sleep and breathing were measured by nocturnal polysomnography at 0 , 7 and 18 weeks .
RESULTS	Testosterone , compared to placebo , worsened the oxygen desaturation index ( ODI ) by 103 events/h ( 95 % CI , 08-198 events/h ; P = 003 ) and nocturnal hypoxaemia ( sleep time with oxygen saturation < 90 % , SpO ( 2 ) T90 % ) by 61 % ( 95 % CI , 15-106 ; P = 001 ) at 7 weeks .
RESULTS	Testosterone therapy did not alter ODI ( 45 , -54 to 144 events/h ; P = 036 ) or SpO ( 2 ) T90 % at 18 weeks ( 29 , -19 -77 % ; P = 023 ) compared to placebo .
RESULTS	The testosterone treatment effects on ODI and SpO ( 2 ) T90 % were not influenced by baseline testosterone concentrations ( testosterone by treatment interactions , all P > 035 ) .
RESULTS	Blood testosterone concentrations did not correlate with ODI or SpO ( 2 ) T90 % ( all P > 019 ) .
CONCLUSIONS	Testosterone therapy in obese men with severe OSA mildly worsens sleep-disordered breathing in a time-limited manner , irrespective of initial testosterone concentrations .
CONCLUSIONS	This time-dependency was not related to testosterone concentrations .
BACKGROUND	www.anzctr.org.au Identifier : ACTRN1260-6000404527 .

###19327948
OBJECTIVE	This study compares the effectiveness of midazolam and dexmedetomidine for the sedation of eclampsia patients admitted to our intensive care unit ( ICU ) .
METHODS	Forty women with eclampsia requiring termination of pregnancy by caesarean delivery were randomized in to 2 groups of 20 to receive either midazolam or dexmedetomidine .
METHODS	The midazolam group received a loading dose of 0.05 mg/kg followed by an infusion of 0.1 mg kg ( -1 ) h ( -1 ) .
METHODS	The dexmedetomidine group loading dose was 1 microg/kg per 20 minutes , followed by continuous infusion at 0.7 microg kg ( -1 ) h ( -1 ) .
METHODS	Heart rate , blood pressure , Ramsey sedation score , antihypertensive need , convulsion fits , and duration in ICU were monitored and recorded all through the ICU stay .
RESULTS	Dexmedetomidine markedly reduced heart rates for the first 24 hours ( P < .05 ) compared with midazolam , but there were no differences at 48 and 72 hours .
RESULTS	Mean arterial blood pressures were similar in the 2 groups ( P > .05 ) , although in the dexmedetomidine group , it was lower at 5 , 6 , 12 , and 24 hours compared with the first 4 hours ( P < .05 ) .
RESULTS	Moreover , fewer patients given dexmedetomidine required nitroglycerine and nitroprusside ( P < .05 ) .
RESULTS	The duration of ICU stay was less in the dexmedetomidine group , 45.5 hours ( range , 15-118 hours ) , than in the midazolam group , 83 hours ( minimum-maximum , 15-312 hours ) .
CONCLUSIONS	Dexmedetomidine sedation in eclampsia patients is effective in reducing the demand for antihypertensive medicine and duration of ICU stay .

###8743003
OBJECTIVE	To assess the safety and intraocular pressure ( IOP ) - lowering activity of 2 % dorzolamide ( topical carbonic anhydrase inhibitor ) , compared to 0.5 % timolol and 0.5 % betaxolol eyedrops .
METHODS	A parallel , masked , randomised one-year clinical trial was conducted in 16 patients with open-angle glaucoma or ocular hypertension , being a subset of a multicentre study which enrolled 523 subjects .
METHODS	Patients had IOP > 22 mmHg in one eye at baseline following washout of ocular hypotensive medications and were then randomised in a 3:1:1 ratio to receive 2 % dorzolamide thrice daily , 0.5 % timolol twice daily or 0.5 % betaxolol twice daily respectively .
METHODS	IOP was measured at Hour 2 ( morning peak ) , Hour 5 and Hour 8 ( afternoon trough for dorzolamide ) at baseline , Weeks 2 and 4 and Months 2 , 3 , 6 , 9 and 12 .
RESULTS	Topical dorzolamide 2 % solution was well tolerated and safe .
RESULTS	Mean IOP for dorzolamide at Hour 2 was 29.1 mmHg at baseline and 20.8 mmHg on treatment at one year , a 28.5 % change .
RESULTS	Mean IOP for dorzolamide at Hour 8 was 24.5 mmHg at baseline and 20.2 mmHg on treatment at one year , a 17.6 % change .
RESULTS	Comparable percent changes for timolol and betaxolol were 43.2 / 25.7 mmHg at Hour 2 and 21.9 / 13.5 mmHg at Hour 8 respectively .
CONCLUSIONS	Dozolamide 2 % given thrice daily was well tolerated and safe , with a clinically significant effect on IOP comparable to betaxolol 0.5 % twice daily , but not as great as timolol 0.5 % twice daily .

###11868059
BACKGROUND	A low level of high-density lipoprotein ( HDLC ) is a proven risk factor for coronary artery disease .
BACKGROUND	Niacin raises HDLC levels , but it is infrequently used because of its side effect profile .
BACKGROUND	Niacin 's side effects are dose related .
BACKGROUND	This study tests the hypothesis that very low-dose niacin , in conjunction with long-term statin therapy , will improve the lipid profile by significantly raising the level of HDLC , with fewer side effects than traditional doses of niacin .
METHODS	Fifty patients undergoing stable statin therapy for 3 months were blindly randomized to receive either placebo or niacin 50 mg administered by mouth 2 times daily for 3 months .
METHODS	Patients with diabetes and active smokers were excluded .
METHODS	Each patient completed a questionnaire regarding current medical problems , medications , and lifestyle before and after the therapy .
METHODS	Patients were questioned about any possible side effects that occurred during the medication trial .
METHODS	The primary end points were change in HDLC level and patient-reported side effects .
RESULTS	Thirty-nine patients completed the study .
RESULTS	Very low-dose niacin added to statin therapy increased the mean HDLC , 2.1 mg/dL in niacin group ( standard error of the mean , 0.767 ) versus -0.56 mg/dL for placebo group ( standard error of the mean -.816 , P = .0246 by analysis of variance ) .
RESULTS	Five patients receiving niacin , versus 2 patients receiving placebo , had episodes of flushing .
RESULTS	No major side effects were noted .
RESULTS	No patients stopped the study medication as a result of side effects .
CONCLUSIONS	The addition of very low-dose niacin to statin therapy increased HDLC cholesterol significantly , while avoiding the side effects that are associated with traditional doses of niacin therapy .

###15118290
BACKGROUND	The present study was designed to examine the hypothesis that minimally-diluted blood cardioplegia ( BCP ) supplemented with potassium and magnesium provides superior myocardial protection in comparison with the standard-diluted BCP for a combination of ` initial , continuous , and intermittent bolus ' BCP administration .
RESULTS	Seventy patients undergoing elective coronary revascularization between 1997 and 2001 ( M : F = 55:15 , mean age 67.6 + / -7.5 years ) were randomly divided into 2 groups : Group C ( n = 35 ) was given the standard 4:1 - diluted blood-crystalloid BCP , and Group M ( n = 35 ) was given minimally-diluted BCP supplemented with potassium-chloride and magnesium-sulfate .
RESULTS	The BCP temperature was maintained at 30 degrees C. Cardioplegic arrest was induced with 2 min of initial antegrade BCP infusion , followed by continuous retrograde BCP infusion .
RESULTS	Intermittent antegrade BCP was infused every 30 min for 2 min .
RESULTS	The time required for achieving cardioplegic arrest was significantly shorter in Group M ( 47.5 + / -16.3 vs 62.5 + / -17.6 s , p < 0.0001 ) .
RESULTS	The number of patients showing spontaneous heart beat recovery after reperfusion was significantly larger in Group M ( 28 vs 15 , p = 0.0029 ) , and the number of patients suffering from atrial fibrillation during the postoperative period was significantly smaller in Group M ( n = 3 vs 11 , p = 0.034 ) .
RESULTS	Both the postoperative maximum dopamine dose ( 3.57 + / -2.46 vs 5.44 + / -2.23 microg/kg per min , p = 0.0014 ) and peak creatine kinase-MB ( 19.5 + / -8.5 vs 25.8 + / -11.9 IU/L , p = 0.0128 ) were significantly less in Group M.
RESULTS	The number of patients showing paradoxical movement of the ventricular septum in the early postoperative echocardiography was significantly smaller in Group M ( 9 vs 24 , p = 0.0007 ) .
CONCLUSIONS	These results suggest that ` initial , continuous and intermittent bolus ' administration of minimally-diluted BCP supplemented with potassium and magnesium is a reliable and effective technique for intraoperative myocardial protection .

###11216968
OBJECTIVE	We aimed to evaluate the benefits of the glycoprotein ( GP ) IIb/IIIa antagonist , eptifibatide , after patients with acute coronary syndromes ( ACS ) were admitted to hospitals that approach revascularization for ACS through early transfer to tertiary referral centers .
BACKGROUND	Across a variety of hospital settings , GP IIb/IIIa inhibition , after patients were admitted to the hospital for non-ST segment elevation ACS , is associated with a reduction in death or myocardial infarction ( MI ) before and during a percutaneous coronary intervention .
METHODS	The outcomes of 429 patients from 153 sites in the Platelet glycoprotein IIb/IIIa in unstable angina : Receptor Suppression Using Integrilin Therapy ( PURSUIT ) trial , who were transferred during study drug infusion ( `` transfer patients '' ) , were compared with those of 1,987 patients who either remained in the hospital at those sites or were transferred after study drug termination ( `` nontransfer patients '' ) .
RESULTS	The baseline characteristics of transfer and nontransfer patients were similar .
RESULTS	Patients receiving eptifibatide were transferred less frequently than those receiving placebo ( 16 % vs. 20 % , p = 0.014 ) .
RESULTS	Transfer patients underwent more procedures and experienced a greater 30-day incidence of death or MI , as compared with nontransfer patients ( 21 % vs. 12 % , p = 0.001 ) .
RESULTS	Eptifibatide was associated with a reduction in death or MI through 30 days , independent of transfer status ( 2.5 % absolute reduction ) , as well as for those transferred ( 5.5 % absolute reduction ) .
CONCLUSIONS	For patients with ACS admitted to community hospitals , eptifibatide is associated with a reduced need for transfer and improved clinical outcomes .

###8306750
OBJECTIVE	The aim of this study was to assess the usefulness of a specific inspiratory muscle training in Duchenne muscular dystrophy ( DMD ) .
METHODS	Fifteen patients with DMD started 6 months of training the inspiratory muscles and 15 patients served as a control group .
METHODS	Pulmonary and inspiratory muscle function parameters were assessed 3 months before and at the beginning of training , in the first and third month of training , at the end , and 6 months after its cessation .
METHODS	Maximal sniff assessed esophageal and transdiaphragmatic pressure values served as indices for global inspiratory muscle strength and diaphragmatic strength , respectively .
METHODS	Inspiratory muscle endurance was assessed by the length of time a certain inspiratory task could be maintained .
RESULTS	In 10 of the 15 patients , respiratory muscle function parameters improved significantly after 1 month of training .
RESULTS	Further improvements were to be seen after 3 and after 6 months .
RESULTS	Even 6 months after the end of training , those effects remained to a large extent .
RESULTS	In the other five patients , there was no such improvement after 1 month of training , which was therefore discontinued .
RESULTS	All these five patients had vital capacity values of less than 25 percent predicted and/or PaCO2 values of more than 45 mm Hg .
RESULTS	The 15 control patients had no significant change in their respiratory muscle function parameters .
CONCLUSIONS	We conclude that a specific inspiratory muscle training is useful in the early stage of DMD .

###24929799
BACKGROUND	The PHARMACOP-intervention significantly improved medication adherence and inhalation technique for patients with COPD compared with usual care .
BACKGROUND	This study aimed to evaluate its cost-effectiveness .
METHODS	An economic analysis was performed from the Belgian healthcare payer 's perspective .
METHODS	A Markov model was constructed in which a representative group of patients with COPD ( mean age of 70years , 66 % male , 43 % current smokers and mean Forced Expiratory Volume in 1second of % predicted of 50 ) , was followed for either receiving the 3-month PHARMACOP-intervention or usual care .
METHODS	Three types of costs were calculated : intervention costs , medication costs and exacerbation costs .
METHODS	Outcome measures included the number of hospital-treated exacerbations , cost per prevented hospital-treated exacerbation and cost per Quality Adjusted Life-Year .
METHODS	Follow-up was 1year in the basecase analysis .
METHODS	Sensitivity and scenario analyses ( including long-term follow-up ) were performed to assess uncertainty .
RESULTS	In the basecase analysis , the average overall costs per patient for the PHARMACOP-intervention and usual care were 2,221 and 2,448 , respectively within the 1-year time horizon .
RESULTS	This reflects cost savings of 227 for the PHARMACOP-intervention .
RESULTS	The PHARMACOP-intervention resulted in the prevention of 0.07 hospital-treated exacerbations per patient ( 0.177 for PHARMACOP versus 0.244 for usual care ) .
RESULTS	Results showed robust cost-savings in various sensitivity analyses .
CONCLUSIONS	Optimization of current pharmacotherapy ( e.g. close monitoring of inhalation technique and medication adherence ) has been shown to be cost-saving and should be considered before adding new therapies .

###19362676
BACKGROUND	Research into mechanisms of skin scarring identified transforming growth factor beta3 ( TGFbeta3 ) as a potential antiscarring therapy .
BACKGROUND	We assessed scar improvement with avotermin ( recombinant , active , human TGFbeta3 ) .
METHODS	In three double-blind , placebo-controlled studies , intradermal avotermin ( concentrations ranging from 0.25 to 500 ng/100 microL per linear cm wound margin ) was administered to both margins of 1 cm , full-thickness skin incisions , before wounding and 24 h later , in healthy men and women .
METHODS	Treatments ( avotermin and placebo or standard wound care ) were randomly allocated to wound sites by a computer generated randomisation scheme , and within-participant controls compared avotermin versus placebo or standard wound care alone .
METHODS	Primary endpoints were visual assessment of scar formation at 6 months and 12 months after wounding in two studies , and from week 6 to month 7 after wounding in the third .
METHODS	Investigators , participants , and scar assessors were blinded to treatment .
METHODS	Efficacy analyses were intention to treat .
METHODS	These studies are registered with ClinicalTrials.gov , numbers NCT00847925 , NCT00847795 , and NCT00629811 .
RESULTS	In two studies , avotermin 50 ng/100 microL per linear cm significantly improved median score on a 100 mm visual analogue scale ( VAS ) by 5 mm ( range -2 to 14 ; p = 0.001 ) at month 6 and 8 mm ( -29 to 18 ; p = 0.0230 ) at month 12 .
RESULTS	In the third , avotermin significantly improved total scar scores at all concentrations versus placebo ( mean improvement : from 14.84 mm [ 95 % CI 5.5-24 .2 ] at 5 ng/100 microL per linear cm to 64.25 mm [ 49.4-79 .1 ] at 500 ng/100 microL per linear cm ) .
RESULTS	Nine [ 60 % ] scars treated with avotermin 50 ng/100 microL per linear cm showed 25 % or less abnormal orientation of collagen fibres in the reticular dermis versus five [ 33 % ] placebo scars .
RESULTS	After only 6 weeks from wounding , avotermin 500 ng/100 microL per linear cm improved VAS score by 16.12 mm ( 95 % CI 10.61-21 .63 ) .
RESULTS	Adverse events at wound sites were similar for avotermin and controls .
RESULTS	Erythema and oedema were more frequent with avotermin than with placebo , but were transient and deemed to be consistent with normal wound healing .
CONCLUSIONS	Avotermin has potential to provide an accelerated and permanent improvement in scarring .

###22562179
OBJECTIVE	The study aimed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance .
METHODS	This was a prospective randomised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and randomised by drawing ballots .
METHODS	Patients that did not speak Swedish could not be recruited .
METHODS	The primary outcomes in this non-blinded study were weight and HbA ( 1c ) .
METHODS	Patients on the LFD aimed for 55-60 energy per cent ( E % ) and those on LCD for 20 E % from carbohydrate .
RESULTS	The mean BMI and HbA ( 1c ) of the participants were 32.7 5.4 kg/m ( 2 ) and 57.0 9.2 mmol/mol , respectively .
RESULTS	No patients were lost to follow-up .
RESULTS	Weight loss did not differ between groups and was maximal at 6 months : LFD -3.99 4.1 kg ( n = 31 ) ; LCD -4.31 3.6 kg ( n = 30 ) ; p < 0.001 within groups .
RESULTS	At 24 months , patients on the LFD had lost -2.97 4.9 kg and those on LCD -2.34 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) .
RESULTS	HbA ( 1c ) fell in the LCD group only ( LCD at 6 months -4.8 8.3 mmol/mol , p = 0.004 , at 12 months -2.2 7.7 mmol/mol , p = 0.12 ; LFD at 6 months -0.9 8.8 mmol/mol , p = 0.56 ) .
RESULTS	At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 0.33 mmol/l to 1.25 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups .
RESULTS	Insulin doses were reduced in the LCD group ( 0 months , LCD 42 65 E , LFD 39 51 E ; 6 months , LCD 30 47 E , LFD 38 48 E ; p = 0.046 for between-group change ) .
CONCLUSIONS	Weight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good .
CONCLUSIONS	Thus , aiming for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative .
BACKGROUND	ClinicalTrials.gov NCT01005498
BACKGROUND	University Hospital of Linkping Research Funds , Linkping University , the County Council of stergtland , and the Diabetes Research Centre of Linkping University .

###25675664
OBJECTIVE	We compared the effects of preincisional peritonsillar infiltration of 5 ml levobupivacaine hydrochloride ( 50 mg/10 ml ) on bleeding during surgery and pain after tonsillectomy in patients aged 16 years or older .
METHODS	The study was conducted in 44 adult patients who underwent tonsillectomy .
METHODS	These patients were randomized to either the study group ( SG ) who received levobupivacaine infiltration to the peritonsillary fossae prior to surgery , or a control group ( CG ) treated with 0.9 % sodium chloride infiltration to the peritonsillary fossae prior to incision .
METHODS	The volume of intraoperative bleeding was recorded .
METHODS	Pain was evaluated using a visual analogue scale ( VAS ) .
METHODS	The first pain score was assessed immediately after arriving in the postoperative care unit .
METHODS	VAS scores were subsequently re-assessed 2 , 4 , 8 , 12 , and 24 hours postoperatively .
METHODS	The first analgesic requirement was assessed 24 hours postoperatively .
RESULTS	The pain relieving effect in the levobupivacaine group was statistically significant 2 , 4 , 12 , and 24 hours postoperatively ( p 0.05 ) , but there was no difference in VAS scores between groups at the first and 8-hour postoperative assessments .
RESULTS	There were no differences between the two groups regarding analgesic requirements .
RESULTS	The difference between the mean intraoperative blood loss in the SG and CG was statistically significant ( p 0.05 ) .
RESULTS	No serious complications were observed in either group .
CONCLUSIONS	Preincisional levobupivacaine infiltration seems to be a safe and easily applied medication for postoperative pain control , and decreased the volume of intraoperative blood loss in adult patients after tonsillectomy .

###8620278
BACKGROUND	Trauma and major surgery stimulate a cascade of events that mediate the inflammatory response .
BACKGROUND	The aim of our study was to determine whether or not hysterectomy leads to release of cytokines , cortisol , and C-reactive protein ( CRP ) , activation of neutrophils , and activation of the complement cascade .
BACKGROUND	A further aim was to compare laparoscopic and abdominal hysterectomy with regard to the same parameters .
METHODS	Twenty-four consecutive patients were randomized to either abdominal ( n = 12 ) or laparoscopic hysterectomy ( n = 12 ) .
METHODS	Blood samples were drawn preoperatively , intraoperatively , and then at one minute , 24 hours , and seven days postoperatively .
METHODS	Interleukin-6 ( IL-6 ) levels were used to evaluate cytokine release , cortisol and CRP to evaluate the inflammatory response , and polymorphonuclear ( PMN ) elastase to detect neutrophil activation .
METHODS	To evaluate complement activation , the terminal C5b-9 complement complex ( TCC ) was determined .
RESULTS	Interleukin-6 concentrations were significantly elevated one minute and 24 hours postoperatively in both groups .
RESULTS	Independent of the surgical technique or operative time , the highest IL-6 concentration was reached four hours after beginning the operation .
RESULTS	Cortisol levels were significantly elevated during and after the operation in both groups .
RESULTS	C-reactive peptide levels were significantly elevated in both groups 24 hours and seven days after the operation .
RESULTS	Polymorphonuclear elastase was elevated 24 hours postoperatively in both groups .
RESULTS	There were no signs of complement activation during the operative period or postoperatively in either patient group .
CONCLUSIONS	Our results indicate serious tissue trauma during both laparoscopic and abdominal hysterectomy .
CONCLUSIONS	The extent of surgical trauma did not differ between the two operative methods .

###21684602
OBJECTIVE	To investigate potential risk factors associated with incident nuclear , cortical , and posterior subcapsular ( PSC ) cataracts and cataract surgery in participants in the Age-Related Eye Disease Study ( AREDS ) .
METHODS	Clinic-based prospective cohort study .
METHODS	Persons ( n = 4425 ) 55 to 80 years of age enrolled in a controlled clinical trial of antioxidant vitamins and minerals , AREDS , for age-related macular degeneration and cataract .
METHODS	Lens photographs were graded centrally for nuclear , cortical , and PSC opacities using the AREDS system for classifying cataracts .
METHODS	Type-specific incident cataracts were defined as an increase in cataract grade from none or mild at baseline to a grade of moderate at follow-up , also with a grade of at least moderate at the final visit , or cataract surgery .
METHODS	Cox regression analyses were used to assess baseline risk factors associated with type-specific opacities and cataract surgery .
METHODS	Moderate cataract was defined as a grade of 4.0 or more for nuclear opacity , 10 % or more involvement within the full visible lens for cortical opacity , and 5 % or more involvement of the central 5-mm circle of the lens for PSC opacity .
METHODS	These were graded on baseline and annual lens photographs .
RESULTS	A clinic-based cohort of 4425 persons 55 to 80 years of age at baseline was followed up for an average of 9.82.4 years .
RESULTS	The following associations were found : increasing age with increased risk of all types of cataract and cataract surgery ; males with increased risk of PSC and decreased risk of cortical cataracts ; nonwhite persons with increased risk of cortical cataract ; hyperopia with decreased risk of PSC , nuclear cataract , and cataract surgery ; Centrum ( Wyeth Consumer Healthcare , Madison , NJ ) use with decreased risk of nuclear cataract ; diabetes with increased risk of cortical , PSC cataract , and cataract surgery ; higher educational level with decreased risk of cortical cataract ; and smoking with increased risk of cortical cataract and cataract surgery .
RESULTS	Estrogen replacement therapy in female participants increased the risk of cataract surgery .
CONCLUSIONS	These findings largely are consistent with the results of previous studies , providing further evidence for possible modifiable risk factors for age-related cataract .
BACKGROUND	The author ( s ) have no proprietary or commercial interest in any materials discussed in this article .

###17403400
OBJECTIVE	The purpose of this study was to determine the effect of early oral bowel stimulation with osmotic laxatives on gastrointestinal function , postoperative nausea and vomiting ( PONV ) and pain in patients who undergo fast-track abdominal hysterectomy .
METHODS	This was a double-blind , placebo-controlled study of 53 women who were assigned randomly to either laxative ( magnesium oxide + disodium phosphate ) or placebo that was initiated 6 hours after the operation .
METHODS	Primary outcome was time to first defecation ; the number of vomiting episodes ; nausea and pain score were assessed on a visual analogue scale .
RESULTS	Time to first postoperative defecation was a median of 45 hours in the laxative group and a median of 69 hours in the placebo group ( P < .0001 ) .
RESULTS	There were no significant differences between groups in pain scores , PONV and the use of morphine or antiemetics .
RESULTS	Postoperative hospitalization was a median of 1 day in the laxative group and of 2 days in the placebo group ( P = .41 ) .
CONCLUSIONS	Laxative improves recovery of gastrointestinal function after fast-track hysterectomy but has no significant effect on pain and PONV .

###16337041
BACKGROUND	Although statin-treatment during the acute phase of unstable coronary syndromes improve the outcome their effects on thrombosis/fibrinolysis system in normocholesterolemic patients admitted with unstable angina remain obscure .
BACKGROUND	We assessed the effects of short-term atorvastatin treatment on thrombotic/fibrinolysis markers in normocholesterolemic in patients with unstable angina .
METHODS	Forty-five patients with unstable angina were allocated into two groups to receive atorvastatin 10 mg/day ( n = 24 ) or no statin ( n = 21 ) for 6 weeks .
METHODS	Circulating levels of von Willebrand Factor ( vWF ) , factor V ( fV ) , protein C ( prC ) , tissue plasminogen activator ( tPA ) and antithrombin III ( ATIII ) were measured by enzyme linked immunosorbent assay , by the patients admission and at the 1st and 6th week of the study .
RESULTS	After 1 week of treatment , a significant increase of ATIII ( p < 0.05 ) , fV ( p < 0.01 ) and vWF ( p < 0.05 ) was found in the control group , but not in atorvastatin-treated group .
RESULTS	Similarly , at 6 weeks after admission , plasma levels of ATIII were still significantly higher than at baseline in controls ( p < 0.05 ) , but not in atorvastatin-treated group .
RESULTS	Plasma levels of PrtC were significantly increased in both controls ( p < 0.01 ) and atorvastatin-treated patients ( p < 0.05 ) at 1 week , while remained unaffected in atorvastatin-treated group at 6th week .
RESULTS	There was no significant difference in the variations of plasma levels of tPA , PrtS and fVII between the two groups at 1 and 6 weeks after admission .
CONCLUSIONS	In normocholesterolemic patients admitted with unstable angina the early administration of atorvastatin , significantly affects von Willebrand factor levels and the expression of liver-derived components of both thrombosis and fibrinolysis system .

###15797959
BACKGROUND	In controlled studies , bisphosphonates have been used to prevent bone loss after solid organ transplantations but not in conjunction with stem cell transplantation ( SCT ) .
OBJECTIVE	The objective of the study was to test whether additional iv pamidronate would prevent bone loss associated with SCT more effectively than the combination of calcium , vitamin D , and sex steroid replacement therapy alone .
METHODS	The study was carried out at the Helsinki University Central Hospital .
METHODS	PATIENTS , DESIGN , INTERVENTION : Ninety-nine adult recipients of allogeneic SCT were randomized by age and gender into two groups .
METHODS	In one group , the patients received 1000 mg calcium carbonate and 800 IU vitamin D daily , and females received estrogen and males received testosterone replacement therapy .
METHODS	In another group , the patients received the same treatments plus six iv infusions of 60 mg pamidronate before and 1 , 2 , 3 , 6 , and 9 months after SCT .
METHODS	Bone mineral density ( BMD ) of the lumbar spine and the upper femur , measured by dual-energy x-ray absorptiometry , and bone turnover markers were followed for 12 months .
RESULTS	In the pamidronate group , lumbar spine BMD remained stable but decreased in the other group by 2.9 % at 12 months ( P = 0.0084 between the groups over time ) .
RESULTS	Total hip BMD reduced 5.1 % in the pamidronate group and 7.8 % in the other group by 12 months ( P = 0.0015 ) , and femoral neck BMD reduced 4.2 and 6.2 % , respectively ( P = 0.074 ) .
RESULTS	In the pamidronate group , serum type I procollagen amino-terminal propeptide ( P = 0.032 between the groups over time ) and urinary type I collagen amino-terminal telopeptide ( P = 0.035 ) decreased 79 and 68 % during the first 3 months , and remained lowered thereafter , but did not change in the other group .
CONCLUSIONS	The recipients of allogeneic SCT receiving additional pamidronate sustain less bone loss than those treated with calcium , vitamin D , and sex steroid replacement alone .
CONCLUSIONS	Despite all the efforts , however , bone loss is not totally abolished at the hip .

###22694796
BACKGROUND	Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders .
BACKGROUND	The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs .
BACKGROUND	The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing .
BACKGROUND	In this paper , the design of the study and baseline findings are described .
METHODS	The design consists of a cluster preference randomized controlled trial .
METHODS	All sheltered housing organisations in the Flanders region ( Belgium ) were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group .
METHODS	Those without a preference were randomly assigned to the intervention or control group .
METHODS	Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual .
METHODS	Outcome assessments occur at baseline , at 10 and at 36 weeks .
METHODS	The primary outcomes include body weight , Body Mass Index , waist circumference , and fat mass .
METHODS	Secondary outcomes consist of physical activity levels , eating habits , health-related quality of life and psychiatric symptom severity .
METHODS	Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate .
METHODS	On the individual level 324 patients were willing to participate , including 225 individuals in the intervention group and 99 individuals in the control group .
METHODS	At baseline , no statistical significant differences between the two groups were found for the primary outcome variables .
CONCLUSIONS	This is the first trial evaluating both the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in mental health care using a cluster preference randomized controlled design .
CONCLUSIONS	The baseline characteristics already demonstrate the unhealthy condition of the study population .
BACKGROUND	This study is registered at clinicaltrials.gov - NCT 01336946 .

###16289977
OBJECTIVE	Coronary arteriosclerotic heart disease frequently develops in patients with diabetes .
OBJECTIVE	Decreases in [ corrected ] serum high-density lipoprotein cholesterol ( HDL-C ) [ corrected ] concentration and low-density lipoprotein ( LDL ) particle size , accompanied by hypertriglyceridemia , are associated with the onset of atherosclerosis .
OBJECTIVE	We recently reported that hypertriglyceridemia was significantly improved in patients with type 2 diabetes who ingested diacylglycerol ( DAG ) oil .
OBJECTIVE	The effect on variables , including LDL particle size related to lipid metabolism , however , was not examined .
OBJECTIVE	The present study investigated the effects on these variables in more detail .
METHODS	Patients with type 2 diabetes ( n = 24 ) were assigned to receive DAG oil or triacylglycerol oil , and a 3-mo , single-blind , controlled study was performed .
METHODS	Patients replaced cooking oil in their daily diet with DAG or triacylglycerol oil , and anthropometry and blood sampling were performed at monthly intervals .
RESULTS	There were no significant differences in calorie intake or amount of test oil ingested between groups .
RESULTS	Waist circumference and serum triacylglycerol concentrations were significantly lower and serum concentrations of high-density lipoprotein cholesterol and apolipoprotein-AI were significantly higher in the DAG oil group than in the triacylglycerol oil group .
RESULTS	Plasma plasminogen activator inhibitor-1 concentrations were significantly lower in the DAG oil group .
RESULTS	LDL particle size tended to increase in the DAG oil group and was significantly larger in patients who had a small initial LDL particle size ( < 25.5 nm ) .
RESULTS	There were no significant differences in variables related to glucose metabolism or in serum concentration of free fatty acids or total ketone bodies .
CONCLUSIONS	These results indicate that DAG oil may be useful for patients who have type 2 diabetes in the management of obesity and lipid abnormalities .

###14572189
OBJECTIVE	The effects of alcohol consumption , alcohol expectancy set and self-reported alcohol expectancies on college students ' perceptions of a potential date rape situation were examined .
OBJECTIVE	It was hypothesized that the effects of alcohol consumption on perceptions of the likelihood of forced sex would be mediated by cognitive factors and perceived sexual arousal .
METHODS	90 female and 90 male college students were randomly assigned to drink alcohol , a placebo beverage , or a nonalcoholic beverage .
METHODS	Participants read a story about a couple that had been drinking together at a party .
METHODS	The story ended with the woman saying `` no '' to sexual intercourse and the man exerting verbal pressure .
RESULTS	Participants ' alcohol consumption during the study , self-reported alcohol expectancies , attitudes about casual sex and usual drinking on dates had significant effects on their perceptions of the story .
RESULTS	Participants ' alcohol expectancy set and gender did not have significant effects on perceptions of the likelihood that the male character would force the female character to have sex .
CONCLUSIONS	Intoxicated participants perceived the woman in the vignette as being more sexually arousedand the man in the vignette as behaving more appropriately , and both of these variables were negatively related to ratings of how likely it was that forced sex would occur .
CONCLUSIONS	These findings highlight the importance of mediating cues in intoxicated decision making .

###23302446
BACKGROUND	Gender differences in schizophrenia include the age of onset , better treatment response , a better outcome , and the peak of the disease in postmenopausal women .
BACKGROUND	Some evidence indicates that these variations are due to estrogen 's effect .
BACKGROUND	The intention of this study was to evaluate the effectiveness of estrogen as an adjuvant agent in the treatment of women with chronic schizophrenia .
METHODS	Study participants were 32 women of childbearing age with chronic schizophrenia .
METHODS	These patients were hospitalized in an institute for the chronically mentally ill .
METHODS	Participants were randomized into two groups : the first group ( 16 cases ) received conjugated estrogens 0.625 mg/day 4 weeks with their previous antipsychotic treatment , while the second group ( 16 cases ) received placebo booster and antipsychotics .
METHODS	The Positive and Negative Syndrome Scale ( PANSS ) was used as a measurement tool for assessing psychopathology .
RESULTS	The combination of conjugated estrogens with antipsychotic treatment showed a significant decrease in positive ( p = 0.003 ) , negative ( p < 0.001 ) , general ( p < 0.001 ) and total ( p < 0.001 ) PANSS scores over 4 weeks .
CONCLUSIONS	Estrogen may be an effective adjuvant agent in the treatment of women with chronic schizophrenia .

###18416257
OBJECTIVE	To compare visual performance of the refractive Array SA40N and the diffractive CeeOn 811E multifocal intraocular lenses ( IOLs ) and to evaluate the potential benefits of combining both multifocal IOLs in the same patient .
METHODS	Two groups of cataract patients were unilaterally implanted with either the CeeOn diffractive ( n = 10 ) or the Array refractive multifocal IOL ( n = 10 ) .
METHODS	Another group was bilaterally implanted with one of each multifocal IOLs ( mix & match group , n = 10 ) .
METHODS	Visual acuity , spectacle independence , depth of focus , contrast sensitivity , presence of photic phenomena , and patient satisfaction were assessed postoperatively .
RESULTS	All eyes achieved good distance visual acuity but better uncorrected near vision was achieved with the CeeOn diffractive design .
RESULTS	Contrast sensitivity with either multifocal IOL was at the lower limit of the normal range but when multifocal IOLs were combined in the same patient , contrast sensitivity was not significantly different from phakic controls .
RESULTS	Defocus curves revealed a superiority of CeeOn diffractive design for near and Array refractive design for intermediate but mix & match patients performed better overall than the other patients , particularly for intermediate distances , which was reflected by total independence from spectacles in 90 % of patients compared to 60 % in the other groups .
RESULTS	Visual outcomes remained unchanged over time ( 1 month vs 6 month vs > 3 years ) .
CONCLUSIONS	Bilateral implantation with a diffractive multifocal IOL in one eye and a refractive multifocal IOL in the fellow eye is safe and could provide patients with better intermediate vision , increased depth of focus and contrast sensitivity , and also less dependence on spectacles .

###8276647
OBJECTIVE	This study is a prospective randomized clinical trial undertaken at our center to compare low dose rate versus high dose rate intracavitary brachytherapy for the treatment of carcinoma uterine cervix .
METHODS	From June 1986 to June 1989 , 482 patients with previously untreated invasive squamous cell carcinoma of the uterine cervix were entered into the study .
METHODS	After an initial clinical examination and investigative work-up the patients were staged according to FIGO staging system .
METHODS	Depending upon the stage of the disease , the size of the local growth and the local cervical anatomy , the patients were divided into two main groups .
METHODS	In group I patients , the predominant treatment was by intracavitary therapy and in group II patients , the predominant therapy was by external beam radiation .
METHODS	In both the groups at the time of intracavity brachytherapy the patients were alternately randomized to receive either low dose rate or high dose rate brachytherapy .
METHODS	There were thus two hundred forty-six patients in the low dose rate group and two hundred thirty-six patients in the high dose rate group .
METHODS	The patients were analyzed for local control , 5 years survival and late radiation morbidity .
RESULTS	Stage for stage the local control rates in the low dose rate group and high dose rate group were similar .
RESULTS	The overall local control achieved in the low dose rate group was 79.7 % as compared to 75.8 % in the high dose rate group .
RESULTS	The 5 years survival figures in the low dose rate and high dose rate group were also comparable .
RESULTS	In Stage I , it was 73 % for low dose rate patients and 78 % for high dose rate patients , for Stage II it was 62 % and 64 % respectively and for Stage III patients it was 50 % and 43 % .
RESULTS	The only statistically significant difference was found in the incidence of overall rectal complications which was 19.9 % for the low dose rate group as compared to only 6.4 % for the high dose rate group .
RESULTS	However , the more severe grade 3-4 complications were not significantly different between the two groups ( 2.4 % vs. 0.4 % , respectively ) .
RESULTS	The bladder morbidity in both the groups was similar .
CONCLUSIONS	Thus high dose rate intracavitary brachytherapy is an equally good alternative to conventional low dose rate brachytherapy in the treatment of carcinoma of the uterine cervix .

###24781217
BACKGROUND	The effectiveness of non-invasive positive pressure ventilation ( NIV ) in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure ( ARF ) remains unclear .
BACKGROUND	We investigated if nocturnal NIV in these patients prolongs the time to readmission for respiratory causes or death ( primary endpoint ) in the following 12months .
METHODS	201 COPD patients admitted to hospital with ARF and prolonged hypercapnia > 48h after termination of ventilatory support were randomised to NIV or standard treatment .
METHODS	Secondary outcomes were daytime arterial blood gasses , transcutaneous PCO2 during the night , lung function , health-related quality-of-life ( HRQL ) , mood state , daily activities and dyspnoea .
RESULTS	1year after discharge , 65 % versus 64 % of patients ( NIV vs standard treatment ) were readmitted to hospital for respiratory causes or had died ; time to event was not different ( p = 0.85 ) .
RESULTS	Daytime PaCO2 was significantly improved in NIV versus standard treatment ( PaCO2 0.5 kPa ( 95 % CI 0.04 to 0.90 , p = 0.03 ) ) as was transcutaneous PCO2 during the night .
RESULTS	HRQL showed a trend ( p = 0.054 , Severe Respiratory Insufficiency questionnaire ) in favour of NIV .
RESULTS	Number of exacerbations , lung function , mood state , daily activity levels or dyspnoea was not significantly different .
CONCLUSIONS	We could not demonstrate an improvement in time to readmission or death by adding NIV for 1year in patients with prolonged hypercapnia after an episode of NIV for ARF .
CONCLUSIONS	There is no reason to believe the NIV was not effective since daytime PaCO2 and night-time PCO2 improved .
CONCLUSIONS	The trend for improvement in HRQL favouring NIV we believe nevertheless should be explored further .
BACKGROUND	NTR1100 .

###17144916
BACKGROUND	The long-acting beta2-agonist ( LABA ) formoterol has an onset of effect comparable to that of salbutamol .
BACKGROUND	Consequently , the combination of formoterol and budesonide in one inhaler , approved for maintenance use , can potentially be used for reliever therapy .
BACKGROUND	This study compared the onset of relief from induced bronchospasm with a single dose of budesonide/formoterol versus standard salbutamol therapy in patients with asthma .
METHODS	In this randomised , double-blind , placebo-controlled , cross-over study , 32 patients with asthma underwent a methacholine provocation test leading to a fall in forced expiratory volume in 1 second ( FEV1 ) of > or = 30 % at enrollment ( Visit 1 ) and three subsequent study visits ( Visits 2-4 ) .
METHODS	Immediately after each provocation at Visits 2-4 , patients received one of three test treatments : one inhalation of budesonide/formoterol 160/4 .5 microg ( via Turbuhaler ) , two inhalations of salbutamol 100 microg ( via a pressurised metered-dose inhaler [ pMDI ] ) or placebo .
METHODS	All patients received each of the test treatments in a randomised order , after separate methacholine provocations .
METHODS	The effect of treatment on FEV1 and breathlessness ( using the Borg scale ) was measured at 1 , 3 , 5 , 10 , 15 , 20 , 25 and 30 minutes after test treatment .
RESULTS	Following methacholine provocation , Borg score increased from a baseline value of below 0.5 to 3.03 , 3.31 and 3.50 before treatment with budesonide/formoterol , salbutamol and placebo , respectively .
RESULTS	Budesonide/formoterol and salbutamol reversed methacholine-induced dyspnoea ( breathlessness ) rapidly .
RESULTS	At 1 minute after inhalation , statistically significant decreases in Borg score were observed for budesonide/formoterol and salbutamol ( p = 0.0233 and p < 0.0001 , respectively , versus placebo ) , with similar rapid increases in FEV1 ( both active treatments p < 0.0001 versus placebo ) .
RESULTS	The median time to 50 % recovery in Borg score after methacholine provocation was 3 minutes with budesonide/formoterol , 2 minutes with salbutamol and 10 minutes with placebo .
RESULTS	All treatments and procedures were well tolerated .
CONCLUSIONS	Single doses of budesonide/formoterol and salbutamol both provided rapid relief of dyspnoea and reversal of severe airway obstruction in patients with asthma with experimentally induced bronchoconstriction .
CONCLUSIONS	The perception of relief , as confirmed by objective lung function assessment , provides evidence that budesonide/formoterol can be used as reliever medication in asthma .

###12427648
BACKGROUND	Current National Cholesterol Education Program guidelines recommend that non-high-density lipoprotein cholesterol ( non-HDL-C ) be considered a secondary target of therapy among individuals with triglycerides > 2.26 mmol/L .
BACKGROUND	It is not known whether non-HDL-C relates to prognosis among patients with coronary heart disease .
RESULTS	Lipid levels were available at baseline among 1514 patients ( 73 % men ; mean age , 61 years ) enrolled in the Bypass Angioplasty Revascularization Investigation ( BARI ) ; all had multivessel coronary artery disease .
RESULTS	Patients were followed for 5 years .
RESULTS	Outcomes of death , nonfatal myocardial infarction , and death or myocardial infarction were modeled using univariate and multivariate time-dependent proportional hazards methods ; angina pectoris at 5 years was modeled using univariate and multivariate logistic regression .
RESULTS	Non-HDL-C was a strong and independent predictor of nonfatal myocardial infarction ( multivariate relative risk , 1.049 [ 95 % confidence intervals , 1.006 to 1.093 ] for every 0.26 mmol/L increase ) and angina pectoris ( multivariate odds ratio , 1.049 [ 95 % confidence intervals , 1.004 to 1.096 ] for every 0.26 mmol/L increase ) , but it did not relate to mortality .
RESULTS	HDL-C and LDL-C did not predict events during follow-up .
CONCLUSIONS	Among patients with lipid values in BARI , non-HDL-C is a strong and independent predictor of nonfatal myocardial infarction and angina pectoris at 5 years , even after consideration of powerful clinical variables .
CONCLUSIONS	Our data suggest that non-HDL-C is an appropriate treatment target among patients with coronary heart disease .

###23132262
BACKGROUND	Patients with severe cardiovascular disease are frequently hemodynamically unstable during abdominal surgery .
BACKGROUND	Improving the safety of such patients by stabilizing intraoperative hemodynamics remains a major concern for anesthesiologists .
BACKGROUND	Transversus abdominis plane ( TAP ) block in combination with general anesthesia may facilitate optimum anesthetic management of these high-risk patients .
METHODS	Patients with cardiovascular disease classified as American Society of Anesthesiologists ( ASA ) physical status 3 were enrolled .
METHODS	The patients were undergoing elective abdominal surgery and were randomized to a group receiving general anesthesia and TAP block ( Group T , N. = 33 ) or a group receiving general anesthesia alone ( Group G , N. = 35 ) .
METHODS	We compared the groups for intraoperative hemodynamic stability , anesthesia emergence time , amounts of anesthetics and opioids given , and frequency of emergency treatment with cardiovascular agents .
METHODS	A preliminary study demonstrated that systolic blood pressure and heart rate were maintained stable within 70-110 % of their preanesthesia values throughout surgery in ASA 1 elderly patients without cardiovascular disease .
METHODS	Thus , the hemodynamically stable time was defined as the time when systolic blood pressure and heart rate were 70-110 % of their preanesthesia values .
METHODS	The ratio of hemodynamically stable time to total operative time was used as an index of hemodynamic stability .
RESULTS	The median ( minimum-maximum ) percentage of hemodynamically stable time was longer in Group T ( 91 [ 50-100 ] % ) than Group G ( 79 [ 40-91 ] % , P < 0.01 ) .
RESULTS	The mean sevoflurane concentration , amount of fentanyl given and frequency of vasopressor use were lower in Group T than Group G ( P < 0.05 ) .
RESULTS	Anesthesia emergence time was shorter in Group T ( 14 [ 4-30 ] min ) than Group G ( 18 [ 9-52 ] min , P < 0.01 ) .
RESULTS	No worsening of cardiovascular complications was observed .
CONCLUSIONS	For abdominal surgery in patients with severe cardiovascular disease , combining TAP block with general anesthesia promotes intraoperative hemodynamic stability and early emergence from anesthesia .

###12404072
BACKGROUND	The subjective , psychomotor , and physiological effects of prescription compounds containing the opioid hydrocodone have not been studied in a population of non-drug-abusing people who might be prescribed these compounds for cough or pain relief .
OBJECTIVE	To characterize the effects of a hydrocodone combination product , Hycodan , which contains hydrocodone and a peripherally-acting anticholinergic , homatropine , in non-drug-abusing volunteers .
METHODS	Eighteen volunteers participated in a crossover , double-blind study in which they received placebo ; 5 mg hydrocodone/1 .5 mg homatropine , 10 mg hydrocodone/3 mg homatropine , 20 mg hydrocodone/6 mg homatropine ( all PO ) ; 40 mg morphine ( PO ) ; and 2 mg lorazepam ( PO ) .
METHODS	Measures were assessed before and for 300 min after drug administration .
METHODS	End-of-session and 24-h measures were taken to assess residual drug effects and overall subjects ' assessment of the drug effects .
METHODS	RESULTS .
METHODS	Subjective effects of the hydrocodone/homatropine combination were dose-related , although the majority of statistically significant effects were limited to the highest dose combination tested .
METHODS	A combination of 20 mg hydrocodone/6 mg homatropine and morphine had a similar profile of subjective effects , which included both pleasant and unpleasant effects .
METHODS	Peak liking ratings were increased by 20 mg hydrocodone/6 mg homatropine and morphine , and trough ratings of liking ( dislike ) were lower in the 20 mg hydrocodone/6 mg homatropine condition , relative to the placebo condition .
METHODS	Post-session ratings of overall liking were not significant , either at the end of the session or 24 h later .
METHODS	Cognitive and psychomotor impairment were more marked with lorazepam than with hydrocodone/homatropine and morphine .
METHODS	Miosis and exophoria were increased in a dose-related manner by hydrocodone/homatropine .
CONCLUSIONS	Hycodan at the highest dose tested had effects similar to that of a prototypic mu agonist , morphine .
CONCLUSIONS	Both drugs produced pleasant ( including drug liking ) as well as unpleasant subjective effects .
CONCLUSIONS	Post-session ratings of overall liking and `` want to take drug again '' were not significant .

###23925936
OBJECTIVE	To compare grip and pinch strength of individuals with carpal tunnel syndrome ( CTS ) to normative values before and after a combined splint/stretching intervention .
METHODS	Data collected on grip and pinch strength on 124 subjects with CTS were compared to age - and sex-matched normative data .
RESULTS	In general , our sample had significantly lower strength than the normative sample at baseline .
RESULTS	Although there were significant improvements in strength after 4 weeks of splinting/exercise , subjects continued to have significant deficits in comparison to the normative data .
CONCLUSIONS	Patients with CTS have moderate to large deficits in grip and pinch strength in comparison to normative data .
CONCLUSIONS	Splinting/stretching may reduce these deficits ; however , CTS patients are often left with residual problems at 4 weeks .

###15370684
BACKGROUND	There is a paucity of detailed and controlled studies on the action of ethanol and alcoholic beverages on gastric emptying in humans .
BACKGROUND	This study was designed to compare the effect of beer , red wine , whisky and their comparable pure ethanol solutions on gastric emptying in a controlled and randomized investigation .
METHODS	On separate days , 10 healthy , fasted subjects received the following solutions , in random order , through a gastric tube : 500 mL beer , red wine , comparable pure ethanol solutions ( 4 % and 10 % v/v ) , glucose ( 5.5 % and 11.4 % w/v ) and water , 125 mL whisky and 40 % ( v/v ) ethanol ( both followed by 125 mL water ) and 250 mL water .
METHODS	Gastric emptying of the test solutions was assessed using ultrasonography of the antrum .
RESULTS	As measured by ultrasonography of the antrum , half emptying times of the ethanol solutions ( 4 % , 10 % and 40 % v/v ) were significantly ( P < 0.05 ) longer ( 22.6 + / - 4.8 , 22.7 + / - 4.3 and 27.8 + / - 3.3 min , respectively , n = 10 ) than those of water ( 14.6 + / - 1.9 min ( 500 mL ) and 13.2 + / - 1.7 min ( 250 mL ) , respectively ) .
RESULTS	The half emptying times of beer ( 39.3 + / - 4.3 min ) and red wine ( 72.6 + / - 7.6 min ) were significantly longer than those of the corresponding ethanol concentrations , whereas whisky was emptied at nearly the same rate ( 26.4 + / - 5.9 min ) as 40 % ( v/v ) ethanol .
RESULTS	Emptying of glucose 5.5 % and 11.4 % ( w/v ) was significantly and dose dependently slower ( 29.7 + / - 4.5 and 64.8 + / - 8.9 min ) than water .
CONCLUSIONS	1 ) Pure ethanol in concentrations of 4 % , 10 % and 40 % ( v/v ) inhibits gastric emptying .
CONCLUSIONS	2 ) The inhibitory effect of beer and red wine , but not of whisky , is stronger than that of their comparable ethanol concentrations .
CONCLUSIONS	3 ) Caloric content and non-alcoholic ingredients in alcoholic beverages produced by fermentation ( beer and wine ) , but not in those produced by distillation ( whisky ) , are most likely responsible for this effect .

###20722677
OBJECTIVE	This study compared the efficacy and safety of tramadol/acetaminophen ( T/A ) and gabapentin in the management of painful diabetic neuropathy .
METHODS	An open , randomized , comparative study was conducted .
METHODS	Subjects with painful symmetric neuropathy in the lower limbs and mean pain-intensity score > or = 4 on a numeric rating scale were eligible .
METHODS	Subjects were randomized to receive either tramadol ( 37.5 mg ) / acetaminophen ( 325 mg ) or gabapentin ( 300 mg ) for 6 weeks .
METHODS	After 2 weeks of the titration period ( 1200 mg/day for gabapentin and three tablets/day for T/A ) , the doses were maintained if the pain was relieved .
METHODS	The primary efficacy outcome was a reduction in pain intensity .
METHODS	Secondary measures evaluated a pain relief scale , a Brief Pain Inventory , a 36-item Short Form Health Survey , average pain intensity and sleep disturbance .
RESULTS	One hundred and sixty-three subjects ( T/A 79 ; gabapentin 84 ) were included .
RESULTS	At the final visit , the mean doses were 1575 mg/day for gabapentin and 4.22 tablets/day for T/A .
RESULTS	Both groups were similar in terms of baseline pain intensity ( mean intensity : T/A 6.7 + / - 1.6 ; gabapentin 6.3 + / - 1.6 , P = 0.168 ) .
RESULTS	At the final visit , the mean reductions in pain intensity were similar in both groups ( T/A -3.1 + / - 2.0 ; gabapentin -2.7 + / - 2.1 , P = 0.744 ) .
RESULTS	Both groups had similar improvements in every Short Form Health Survey category and Brief Pain Inventory subcategory , and in the mean pain relief scores .
CONCLUSIONS	This study suggests that the T/A combination treatment is as effective as gabapentin in the treatment of painful diabetic neuropathy in patients with Type 2 diabetes .

###23418046
OBJECTIVE	To evaluate the effects of the anti-TNF - monoclonal antibody golimumab , administered by s.c. injection or i.v. infusion , on markers of inflammation in patients with RA .
METHODS	In this phase 1 , open-label study , patients with active RA were randomized to receive s.c. golimumab 100 mg at baseline and every 4 weeks through week 20 ( n = 33 ; group 1 ) or i.v. golimumab 2 mg/kg at baseline and week 12 ( n = 16 ; group 2 ) .
METHODS	Serum levels of CRP , IL-6 , serum amyloid A ( SAA ) , TNF receptor II ( TNFRII ) , MMP-3 , hyaluronic acid , haptoglobin , ferritin and haemoglobin and serum/urine hepcidin were measured at various time points .
METHODS	Associations between the biomarkers were assessed with Spearman 's correlations .
RESULTS	In both groups 1 and 2 , decreases in mean serum levels of CRP , IL-6 , SAA , TNFRII , MMP-3 , haptoglobin , ferritin and hepcidin , and mean urine levels of hepcidin occurred within 1 week and were sustained through week 8 .
RESULTS	Decreases in concentrations of serum CRP , IL-6 , SAA , MMP-3 , hepcidin , ferritin and haptoglobin and urine hepcidin were maintained through week 24 in group 1 , but began to reverse after week 8 in group 2 .
RESULTS	Among all patients , decreases in serum hepcidin correlated significantly with decreases in serum CRP and ferritin .
CONCLUSIONS	Decreases in serum and urine concentrations of markers of inflammation occurred as early as 24 h after treatment with golimumab , and most of these improvements were sustained through week 24 in group 1 .

###23715024
METHODS	Randomized prospective trial .
OBJECTIVE	To compare the efficacy of intravenous analgesia with single and dual continuous epidural analgesia ( CEA ) in patients with adolescent idiopathic scoliosis ( AIS ) undergoing posterior spinal fusion and instrumentation ( PSIF ) .
BACKGROUND	Pain management after posterior spinal fusion ( PSF ) for patients with AIS is challenging .
BACKGROUND	Although intravenous patient-controlled analgesia ( PCA ) is used most commonly , CEA has been found to be safe and effective .
BACKGROUND	Recently , the use of 2 epidural catheters has been thought to be more effective than a single catheter , although the efficacy of using 2 catheters has not been directly compared with a single catheter .
METHODS	Sixty-six patients with AIS were randomized into 3 groups prior to PSF ; PCA , single CEA , and double CEA .
METHODS	Postoperative pain scores as well as side effects , complications , and use of breakthrough medication were collected .
METHODS	Recovery times were also recorded , including hospitalization , times to first bowel movement , and days to walk and climb stairs .
METHODS	Four patients were withdrawn due to the inability to maintain the pain management protocol .
RESULTS	Pain intensity was most effectively controlled with a double CEA when compared with PCA ( P < 0.05 ) and a single CEA ( P < 0.05 ) .
RESULTS	Pain control was equivalent in both the PCA and single CEA groups ( P = 0.21 ) .
RESULTS	The pain control method with the fewest side effects trended toward the single CEA , with an average of 2.55 side effects per patient .
RESULTS	The majority of the side effects included pruritis , constipation , and nausea .
RESULTS	Late onset neurological events were absent in all patients .
CONCLUSIONS	These data document that the double CEA most effectively controls postoperative pain after surgery for AIS .
CONCLUSIONS	The single CEA trended toward having the fewest side effects when compared with the other techniques .
CONCLUSIONS	On the basis these findings , we now routinely use the double CEA technique for all patients having surgery for AIS .

###16014884
BACKGROUND	In the treatment of atrioventricular block , dual-chamber cardiac pacing is thought to confer a clinical benefit as compared with single-chamber ventricular pacing , but the supporting evidence is mainly from retrospective studies .
BACKGROUND	Uncertainty persists regarding the true benefits of dual-chamber pacing , particularly in the elderly , in whom it is used less often than in younger patients .
METHODS	In a multicenter , randomized , parallel-group trial , 2021 patients 70 years of age or older who were undergoing their first pacemaker implant for high-grade atrioventricular block were randomly assigned to receive a single-chamber ventricular pacemaker ( 1009 patients ) or a dual-chamber pacemaker ( 1012 patients ) .
METHODS	In the single-chamber group , patients were randomly assigned to receive either fixed-rate pacing ( 504 patients ) or rate-adaptive pacing ( 505 patients ) .
METHODS	The primary outcome was death from all causes .
METHODS	Secondary outcomes included atrial fibrillation , heart failure , and a composite of stroke , transient ischemic attack , or other thromboembolism .
RESULTS	The median follow-up period was 4.6 years for mortality and 3 years for other cardiovascular events .
RESULTS	The mean annual mortality rate was 7.2 percent in the single-chamber group and 7.4 percent in the dual-chamber group ( hazard ratio , 0.96 ; 95 percent confidence interval , 0.83 to 1.11 ) .
RESULTS	We found no significant differences between the group with single-chamber pacing and that with dual-chamber pacing in the rates of atrial fibrillation , heart failure , or a composite of stroke , transient ischemic attack , or other thromboembolism .
CONCLUSIONS	In elderly patients with high-grade atrioventricular block , the pacing mode does not influence the rate of death from all causes during the first five years or the incidence of cardiovascular events during the first three years after implantation of a pacemaker .

###20100633
OBJECTIVE	The present study was undertaken to test bioresorbable fixation versus titanium for equivalence in terms of clinical union and complications using the American Association of Oral and Maxillofacial Surgeons parameters of care .
OBJECTIVE	The study design was a randomized , controlled , equivalence trial .
METHODS	A total of 40 patients were enrolled and allocated to the titanium group and bioresorbable group using a computerized randomization table .
METHODS	All were plated using standard plating principles .
METHODS	In the bioresorbable group , 2 weeks of maxillomandibular fixation was also used .
METHODS	Evaluation of the study endpoint was done at 8 weeks postoperatively .
METHODS	For statistical analysis , the upper limit of the 95 % confidence interval was calculated for failure to achieve the primary outcome variable and compared with the maximal clinically acceptable difference between the standard and test modalities in the failure to achieve clinical union ( delta ) .
METHODS	Delta was predetermined as 2 % .
METHODS	The other complications were tested for significance using Fisher 's exact test .
RESULTS	Of the 40 patients , 21 were in the titanium group and 19 were in the bioresorbable group , with 20 men and 1 woman in the titanium group and 18 men and 1 woman in the bioresorbable group .
RESULTS	The mean age was 28.7 years in the titanium group and 26.6 years in the bioresorbable group .
RESULTS	In the titanium group , the complications noted were nonunion in 0 % , malocclusion in 7.7 % , continued postoperative swelling in 0 % , chronic pain in 2 % , infection in 5.2 % , an inability to chew hard food after 8 weeks in 7.7 % , the need for alternative treatment in 0 % , and the need for reoperation in 31 % .
RESULTS	In the bioresorbable group , the complications were nonunion in 4.17 % , malocclusion in 11.1 % , swelling in 8.3 % , chronic pain in 37.5 % , infection in 0 % , an inability to chew hard food in 11.1 % , the need for alternative treatment in 11.1 % , and need for reoperation for plate removal in 0 % .
CONCLUSIONS	The small sample size did not allow any meaningful conclusion to be drawn from the present study in terms of the primary question of achieving union .
CONCLUSIONS	Both groups matched in outcomes when evaluated only on a clinical basis .
CONCLUSIONS	The avoidance of repeat surgery for plate removal is a definite advantage of using resorbable plates .
CONCLUSIONS	However , the results are inconclusive in favor of any particular plating system .

###23748313
OBJECTIVE	It has been reported that multiple abutment disconnections and reconnections following implant placement may compromise the peri-implant mucosal seal and may lead to increased marginal bone loss .
OBJECTIVE	Thus , the aim of this study was to evaluate the effect of healing abutment disconnection and reconnection on soft and hard peri-implant tissues .
METHODS	Sixteen patients were included in this prospective randomized controlled clinical trial .
METHODS	Following one-stage implant placement , test group implants ( n = 10 ) received a permanent abutment and control group implants ( n = 11 ) received a healing abutment .
METHODS	After 2 months of healing , control group implants underwent a prosthetic protocol involving implant-level impressions and a two-time abutment disconnection and reconnection process prior to delivery of the definitive prosthesis .
METHODS	Test group implants underwent a prosthetic protocol involving abutment-level impressions without any abutment disconnection .
METHODS	Clinical parameters were recorded at 2 weeks , 2 months , 3 months , and 6 months , and marginal bone levels were assessed radiographically at implant placement , 3 months , and 6 months .
RESULTS	The overall survival rate from implant placement to the last follow-up visit was 100 % for both groups .
RESULTS	The mean marginal bone loss at the 6-month examination was 0.13 mm for test group implants and 0.28 mm for control group implants .
RESULTS	There were no significant differences regarding changes in peri-implant mucosal dimensions between the two groups .
CONCLUSIONS	The present study indicates that implants receiving a final abutment at the time of implant placement exhibited minimal marginal bone loss and were similar to implants subjected to abutment disconnection and reconnection two times .
CONCLUSIONS	Disconnection and reconnection of the abutment two times did not cause negative dimensional changes in the peri-implant mucosa .

###23110382
BACKGROUND	As the number of people with diabetes is increasing rapidly worldwide , a more thorough understanding of the psychosocial aspects of living with this condition has become an important health care priority .
BACKGROUND	While our knowledge has grown substantially over the past two decades with respect to the physical , emotional and social difficulties that people with diabetes may encounter , many important issues remain to be elucidated .
BACKGROUND	Under the umbrella of the Diabetes MILES ( Management and Impact for Long-term Empowerment and Success ) Study International Collaborative , Diabetes MILES -- The Netherlands aims to examine how Dutch adults with diabetes manage their condition and how it affects their lives .
BACKGROUND	Topics of special interest in Diabetes MILES -- The Netherlands include subtypes of depression , Type D personality , mindfulness , sleep and sexual functioning .
METHODS	Diabetes MILES -- The Netherlands was designed as a national online observational study among adults with diabetes .
METHODS	In addition to a main set of self-report measures , the survey consisted of five complementary modules to which participants were allocated randomly .
METHODS	From September to October 2011 , a total of 3,960 individuals with diabetes ( 40 % type 1 , 53 % type 2 ) completed the battery of questionnaires covering a broad range of topics , including general health , self-management , emotional well-being and contact with health care providers .
METHODS	People with self-reported type 1 diabetes ( specifically those on insulin pump therapy ) were over-represented , as were those using insulin among respondents with self-reported type 2 diabetes .
METHODS	People from ethnic minorities were under-represented .
METHODS	The sex distribution was fairly equal in the total sample , participants spanned a broad age range ( 19-90 years ) , and diabetes duration ranged from recent diagnosis to living with the condition for over fifty years .
CONCLUSIONS	The Diabetes MILES Study enables detailed investigation of the psychosocial aspects of living with diabetes and an opportunity to put these findings in an international context .
CONCLUSIONS	With several papers planned resulting from a pooled Australian-Dutch dataset and data collections planned in other countries , the Diabetes MILES Study International Collaborative will contribute substantially to identifying potentially unmet needs of those living with diabetes and to inform clinical research and care across the globe .

###17928994
OBJECTIVE	Elevated blood glucose is associated with poor outcome in patients resuscitated from out-of-hospital cardiac arrest ( OHCA ) .
OBJECTIVE	Our aim was to determine whether strict glucose control with intensive insulin treatment improves outcome of OHCA patients .
METHODS	A randomized , controlled trial .
METHODS	Two university hospital intensive care units .
METHODS	Ninety patients resuscitated from OHCA with ventricular fibrillation detected as the initial rhythm were treated with therapeutic hypothermia .
METHODS	Patients were randomized into two treatment groups : a strict glucose control group ( SGC group ) , with a blood glucose target of 4-6 mmol/l , or a moderate glucose control group ( MGC group ) , with a blood glucose target of 6-8 mmol/l .
METHODS	Both groups were treated with insulin infusion for 48 h , because a control group with no treatment was considered unethical .
RESULTS	Baseline data were similar in both groups .
RESULTS	In the SGC group 71 % of the glucose measurements were within the target range compared with 41 % in the MGC group .
RESULTS	Median glucose was 5.0 mmol/l in the SGC group and 6.4 mmol/l in the MGC group .
RESULTS	The occurrence of moderate hypoglycemic episodes was 18 % in the SGC group and 2 % in the MGC group ( p = 0.008 ) .
RESULTS	No episodes of severe hypoglycemia occurred .
RESULTS	Mortality by day 30 was 33 % in the SGC group and 35 % in the MGC group ( p = 0.846 ) ; the difference was 2 % ( 95 % CI -18 % to +22 % ) .
CONCLUSIONS	We found no additional survival benefit from strict glucose control compared with moderate glucose control with a target between 6 and 8 mmol/l in OHCA patients .

###21291529
BACKGROUND	The purpose of the present study was to investigate the relationship of expression of hypoxia inducible factor ( HIF ) -1 - modifying enzymes prolyl hydroxylase ( PHD ) 1 , PHD2 and PHD3 to response of tumours and survival in breast cancer patients enrolled in a phase II trial of neoadjuvant anthracycline and tamoxifen therapy .
METHODS	The expression of PHD1 , PHD2 and PHD3 together with HIF-1 and the HIF-inducible genes vascular endothelial cell growth factor ( VEGF ) and carbonic anhydrase IX were assessed by immunohistochemistry using a tissue microarray approach in 211 patients with T2-4 N0-1 breast cancer enrolled in a randomised trial comparing single-agent epirubicin versus epirubicin and tamoxifen as the primary systemic treatment .
RESULTS	PHD1 , PHD2 and PHD3 were detected in 47/179 ( 26.7 % ) , 85/163 ( 52.2 % ) and 69/177 ( 39 % ) of tumours at baseline .
RESULTS	PHD2 and PHD3 expression was moderate/strong whereas PHD1 expression was generally weak .
RESULTS	There was a significant positive correlation between HIF-1 and PHD1 ( P = 0.002 ) and PHD3 ( P < 0.05 ) but not PHD2 ( P = 0.41 ) .
RESULTS	There was a significant positive relationship between VEGF and PHD1 ( P < 0.008 ) and PHD3 ( P = 0.001 ) but not PHD2 ( P = 0.09 ) .
RESULTS	PHD1 , PHD2 and PHD3 expression was significantly increased after epirubicin therapy ( all P < 0.000 ) with no significant difference in PHD changes between the treatment arms .
RESULTS	There was no significant difference in response in tumours that expressed PHDs and PHD expression was not associated with survival .
CONCLUSIONS	Although expression of the PHDs was not related to response or survival in patients receiving neoadjuvant epirubicin , our data provide the first evidence that these enzymes are upregulated on therapy in breast cancer and that the biological effects independent of HIF make them therapeutic targets .

###22101205
BACKGROUND	Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy .
BACKGROUND	This paper describes the protocol for a randomised controlled trial ( RCT ) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy ( CBT ) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care .
METHODS	CoBalT is a two parallel group multi-centre pragmatic RCT .
METHODS	Eligible participants were those who : ( i ) were aged 18-75years ; ( ii ) were currently taking antidepressant medication ( for at least 6weeks at an adequate dose ) ; ( iii ) scored 14 on the Beck Depression Inventory ( BDI-II ) ; ( iv ) had adhered to their medication ; and ( v ) met ICD-10 criteria for depression ( assessed using the Clinical Interview Schedule - revised version ) .
METHODS	Those who gave written informed consent were randomised to one of two treatment groups : usual care or usual care plus CBT .
METHODS	The primary outcome is depressive symptoms assessed using the BDI-II at 6months post-randomisation .
METHODS	Secondary outcomes measured at 6 and 12months include quality of life , antidepressant use and health care utilisation .
METHODS	Outcomes will be analysed on an intention-to-treat basis .
CONCLUSIONS	The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy .
CONCLUSIONS	Given the move to widen access to ` talking therapies ' , the results of this study will be timely .

###10992533
BACKGROUND	It has been reported that intranasal corticosteroids can influence bronchial hyperresponsiveness ( BHR ) in asthmatic subjects with seasonal rhinitis .
BACKGROUND	The purpose of the present study was to evaluate the effect of intranasal fluticasone propionate and beclomethasone dipropionate on BHR and bronchial calibre ( forced expiratory volume in one second , FEV ( 1 ) ) in children and young adults with seasonal rhinitis and mild asthma during two consecutive grass pollen seasons .
METHODS	In the first pollen season 25 patients aged 8-28 years were included in a double blind , placebo controlled study .
METHODS	The active treatment group used fluticasone aqueous spray 200 microgram once daily .
METHODS	In the second pollen season 72 patients aged 8-28 years participated in a double blind , placebo controlled study of a similar design to that of the previous year except that an additional treatment group of patients using beclomethasone 200 microg twice daily was included .
METHODS	FEV ( 1 ) was measured before and after three and six weeks of treatment ; BHR to methacholine ( PD ( 20 ) ) was measured before and after six weeks of treatment .
RESULTS	In the first season the mean ( SD ) logPD ( 20 ) of the patients decreased significantly both in the fluticasone group ( from 2.43 ( 0.8 ) microgram to 1.86 ( 0.85 ) microgram ) and in the placebo group ( from 2.41 ( 0.42 ) microgram to 1.87 ( 0.78 ) microgram ) without any intergroup difference in the change in logPD ( 20 ) .
RESULTS	In the second pollen season the mean logPD ( 20 ) in the fluticasone , beclomethasone , and placebo groups did not change significantly .
CONCLUSIONS	Intranasal steroids did not influence BHR during two grass pollen seasons in children and young adults with seasonal rhinitis and mild asthma .

###9388088
BACKGROUND	Much has been written about the potential role of antioxidants in the prevention of atherosclerosis .
OBJECTIVE	To assess the short-term effect of a single high-fat meal with and without pretreatment with antioxidant vitamins on endothelial function in healthy , normocholesterolemic subjects .
METHODS	Observer-blinded randomized trial .
METHODS	University hospital .
METHODS	Twenty healthy , normocholesterolemic ( total and low-density lipoprotein cholesterol < 5.2 mmol/L and < 3.4 mmol/L [ < 200 mg/dL and < 130 mg / dL ] , respectively ) , male ( 7 ) and female ( 13 ) hospital employee volunteers , aged 24 to 54 years .
METHODS	Three randomly administered breakfasts : ( 1 ) a high-fat meal ( 3766 J [ 900 calories ] , 50 g of fat ) ; ( 2 ) a low-fat meal ( 3766 J [ 900 calories ] , 0 g of fat ) ; and ( 3 ) a high-fat meal and pretreatment with oral administration of vitamins C ( 1 g ) and E ( 800 IU ) ( high-fat meal with vitamins ) .
METHODS	A subgroup of 10 subjects also ate the low-fat meal with the same vitamin pretreatment ( low-fat meal with vitamins ) .
METHODS	High-resolution ultrasound assessed flow-mediated ( endothelium-dependent ) brachial artery vasodilation measured as percent diameter change before and hourly for 6 hours following each meal .
RESULTS	Flow-mediated vasodilation fell from a mean + / - SD of 20 % + / -8 % before to 12 % + / -6 % , 10 % + / -6 % , and 8 % + / -9 % at 2 , 3 , and 4 hours , respectively , after the high-fat meal ( P < .001 ) .
RESULTS	No significant changes in flow-mediated vasodilation occurred after the low-fat meal , high-fat meal with vitamins , or low-fat meal with vitamins .
RESULTS	The change in flow-mediated vasodilation after the low-fat and high-fat meals correlated inversely with the 2-hour postprandial change in triglyceride levels ( r = -0.54 ; P < .001 ) .
CONCLUSIONS	A single high-fat meal transiently reduces endothelial function for up to 4 hours in healthy , normocholesterolemic subjects , probably through the accumulation of triglyceride-rich lipoproteins .
CONCLUSIONS	This decrease is blocked by pretreatment with antioxidant vitamins C and E , suggesting an oxidative mechanism .

###25270426
BACKGROUND	Cognitive behavioral therapy ( CBT ) and U.S. Food and Drug Administration ( FDA ) - recommended pharmacologic treatments ( RPTs ; pregabalin , duloxetine , and milnacipran ) are effective treatment options for fibromyalgia ( FM ) syndrome and are currently recommended by clinical guidelines .
BACKGROUND	We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT ( combination of pregabalin + duloxetine ) and usual care ( TAU ) groups in the treatment of FM .
METHODS	The economic evaluation was conducted alongside a 6-month , multicenter , randomized , blinded , parallel group , controlled trial .
METHODS	In total , 168 FM patients from 41 general practices in Zaragoza ( Spain ) were randomized to CBT ( n = 57 ) , RPT ( n = 56 ) , or TAU ( n = 55 ) .
METHODS	The main outcome measures were Quality-Adjusted Life Years ( QALYs , assessed by using the EuroQoL-5D questionnaire ) and improvements in health-related quality of life ( HRQoL , assessed by using EuroQoL-5D visual analogue scale , EQ-VAS ) .
METHODS	The costs of healthcare use were estimated from patient self-reports ( Client Service Receipt Inventory ) .
METHODS	Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves ( CEACs ) .
RESULTS	On average , the total costs per patient in the CBT group ( 1,847 ) were significantly lower than those in patients receiving RPT ( 3,664 ) or TAU ( 3,124 ) .
RESULTS	Patients receiving CBT reported a higher quality of life ( QALYs and EQ-VAS scores ) ; the differences between groups were significant only for EQ-VAS .
RESULTS	From a complete case-analysis approach ( base case ) , the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed , by using both QALYs and EQ-VAS as outcomes .
RESULTS	These findings were confirmed by bootstrap analyses , net-benefit curves , and CEACs .
RESULTS	Two additional sensitivity analyses ( intention-to-treat analysis and per-protocol analysis ) indicated that the results were robust .
RESULTS	The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs , although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS .
CONCLUSIONS	Because of lower costs , CBT is the most cost-effective treatment for adult FM patients .
CONCLUSIONS	Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT .
BACKGROUND	Current Controlled Trials ISRCTN10804772 .
BACKGROUND	Registered 29 September 2008 .

###9631161
BACKGROUND	The study objective was to determine the impact of receiving results of a blood cholesterol test on changes in dietary behaviors among individuals participating in a Health Risk Appraisal Program .
METHODS	This randomized trial of maintenance employees at six hospitals included two groups : Group 1 received their blood cholesterol test results at the pretest ; Group 2 received results only at the posttest ( 16-20 weeks later ) .
METHODS	The pretest interview included ( 1 ) a 24-hour dietary recall ; ( 2 ) an evaluation of dietary behaviors and suggestions on how to change ; ( 3 ) height , weight , and blood cholesterol measurement .
METHODS	Five hundred employees participated , and 429 eligible employees completed both pretest and posttest interviews .
RESULTS	Blood cholesterol levels decreased by 4.8 % ( P < .001 ) and saturated fat intake decreased by 7.4 % ( P < .05 ) .
RESULTS	Regression analyses indicated that individuals more likely to have lowered saturated fat intake had higher pretest saturated fat intakes , had a family history of high blood cholesterol , and were light-maintenance employees ( P < .05 ) ; no other variables were associated ( receiving blood cholesterol test results , previous blood cholesterol test , pretest blood cholesterol levels , personal history of heart disease , BMI , age , gender , tobacco/alcohol use ) .
RESULTS	Among subjects with normal cholesterol levels , those not receiving blood test results reduced saturated fat intake more than those receiving test results ; both groups had similar saturated fat intakes ( > 12 % ) greater than recommended intake ( < 10 % ) .
CONCLUSIONS	Screening programs should include an assessment of saturated fat intake as screening for blood cholesterol may provide normocholesterolemic subjects with a false sense of security .

###12379064
BACKGROUND	Warfarin is used for prophylaxis of venous thromboembolism in patients undergoing total knee arthroplasty .
BACKGROUND	However , it is associated with rates of deep venous thrombosis ( DVT ) of approximately 38 % to 55 % and requires routine coagulation monitoring and frequent dose adjustment .
BACKGROUND	Ximelagatran , an oral direct thrombin inhibitor , has shown promising efficacy and tolerability in patients undergoing total hip or knee arthroplasty .
OBJECTIVE	To compare the efficacy and safety of ximelagatran and warfarin for prophylaxis of venous thromboembolism after total knee arthroplasty .
METHODS	Randomized , double-blind , parallel-group trial .
METHODS	74 North American hospitals .
METHODS	680 patients who had undergone total knee arthroplasty .
METHODS	7 to 12 days of treatment with oral ximelagatran , 24 mg twice daily , starting on the morning after surgery , or warfarin ( target international normalized ratio , 2.5 [ range , 1.8 to 3.0 ] ) , starting on the evening of the day of surgery .
METHODS	Principal end points were asymptomatic DVT on mandatory venography ; symptomatic DVT confirmed by ultrasonography or venography ; symptomatic , objectively proven pulmonary embolism ; and bleeding .
METHODS	All were assessed by blinded adjudication locally and at a central study laboratory .
RESULTS	On central adjudication , incidence of venous thromboembolism was 19.2 % ( 53 of 276 patients ) in the ximelagatran group and 25.7 % ( 67 of 261 patients ) in the warfarin group ( difference , -6.5 percentage points [ 95 % CI , -13.5 to 0.6 percentage points ] ; P = 0.070 ) .
RESULTS	On local assessment , incidence was 25.4 % in the ximelagatran group and 33.5 % in the warfarin group ( P = 0.043 ) .
RESULTS	In the ximelagatran and warfarin groups , respectively , major bleeding occurred in 1.7 % and 0.9 % of patients and minor bleeding occurred in 7.8 % and 6.4 % of patients .
RESULTS	No variables related to bleeding differed significantly between the two groups .
CONCLUSIONS	For prophylaxis of venous thromboembolism , fixed-dose ximelagatran started the morning after total knee arthroplasty is well tolerated and at least as effective as warfarin , but it does not require coagulation monitoring or dose adjustment .

###24145806
BACKGROUND	We compared two methods of asleep fibreoptic intubation in patients at risk of secondary cervical injury : the Aintree Intubation Catheter via a classic laryngeal mask airway ( cLMA ) versus the Fastrach technique via the intubating laryngeal mask airway ( iLMA ) .
OBJECTIVE	To test which system has the highest rate of successful intubations in the clinical setting .
METHODS	A randomised controlled study .
METHODS	Single-centre , between 2007 and 2010 .
METHODS	We randomly allocated 80 patients ( 30 women and 50 men ) who underwent elective neurosurgery of the cervical spine to either group , placed in a neutral position and wearing a soft cervical collar .
METHODS	Entry criteria were ASA status 1 to 3 , age 18 to 80 years and written informed consent .
METHODS	Exclusion criteria were patients with cervical instability , known or predicted difficult airway , BMI greater than 40 kg m and symptomatic gastro-oesophageal reflux .
METHODS	Two anaesthetists who were experienced in both techniques performed all anaesthesia procedures within the study .
METHODS	There was a maximum of three attempts for performing each technique .
METHODS	The primary outcome was the rate of successful fibreoptic intubation in a neutral position .
METHODS	We also investigated the timing sequence for both techniques , the Brimacombe and Berry Bronchoscopy Score , and differences in technical aspects .
RESULTS	All 40 patients in the Aintree group but only 31 patients in the Fastrach group were intubated successfully .
RESULTS	Thus , fibreoptic intubation failed significantly less using the Aintree technique ( P = 0.002 ) .
RESULTS	For secondary outcomes , the cLMA was faster ( 260 versus 289 s , P = 0.039 ) and easier ( P = 0.036 ) to insert than the iLMA .
RESULTS	The fibreoptic view of the glottis according to the Brimacombe and Berry Bronchoscopy Score was better ( P = 0.016 ) and the tracheal tube was easier to insert ( P = 0.010 ) in the Aintree group .
CONCLUSIONS	Fibreoptic intubation using the Aintree system was more successful than the Fastrach technique in our population of patients in a neutral position wearing a soft cervical collar .
CONCLUSIONS	The differences in the time to successful intubation between the two groups are unlikely to be clinically relevant .

###22368041
OBJECTIVE	Wireless pH monitoring is currently employed in the distal esophagus .
OBJECTIVE	There are no controlled studies on the feasibility/safety of proximal esophageal wireless pH capsule placement .
OBJECTIVE	We tested the hypothesis that there will be no difference in patient perception of a more proximally placed pH capsule .
METHODS	Randomized single-blinded sham-controlled trial .
METHODS	Tertiary care center .
METHODS	All patients had a wireless pH capsule positioned 6 cm proximal to the gastroesophageal junction .
METHODS	They were randomized into intervention or sham groups after distal capsule placement .
METHODS	The delivery introducer was positioned 10 cm proximal to the distal esophageal capsule , and a second capsule was either deployed ( intervention ) or not ( sham ) based on group allocation .
METHODS	Patients were blinded to group assignment .
METHODS	Modified Edmonton Score was used to assess for chest pain , dysphagia , and odynophagia .
METHODS	The primary endpoints were ( 1 ) required endoscopic removal because of discomfort and ( 2 ) change in chest pain scores , controlling for baseline pain .
RESULTS	Patients were randomized to either the intervention , proximal esophageal capsule ( n = 11 ) , or sham ( n = 11 ) .
RESULTS	Patients with proximal pH probes had higher odds of having their chest pain ( odds ratio [ OR ] , 8.44 ; 95 % confidence interval [ CI ] , 1.35-52 .6 ; P = .02 ) , odynophagia ( OR , 49.5 ; 95 % CI , 4.70-520 ; P = .001 ) , and dysphagia ( OR , 14.3 ; 95 % CI , 2.12-96 .6 ; P = .006 ) exacerbated .
RESULTS	Two ( 2/11 ; 18 % ) proximally deployed probes required endoscopic removal because of patient intolerance or discomfort .
CONCLUSIONS	A proximal esophageal wireless pH monitor placement is feasible but results in increased chest pain , odynophagia , and dysphagia that can be severe enough to require endoscopic removal .
CONCLUSIONS	These limitations preclude its potential clinical benefit .

###21197854
BACKGROUND	Caffeine ingestion has been demonstrated to increase physical performance in some situations .
BACKGROUND	This study examined the ability of a commercial energy drink containing caffeine to enhance acceleration tolerance and strength under G load .
METHODS	Eight experienced centrifuge subjects completed three separate experimental acceleration exposures following ingestion of 11.5 ml x kg ( -1 ) bodyweight of ( 1 ) a commercial energy drink , providing 5.0 mg caffeine/kg bodyweight ; ( 2 ) a commercial energy drink without caffeine ; or 3 ) a placebo .
METHODS	The acceleration exposures consisted of a relaxed gradual onset run to peripheral light loss , a rapid onset run to 6 G for 15 s , and a simulated air combat maneuver ( SACM ) run of repeated alternations between 4.5 G for 15 s and 7 G for 15 s until volitional exhaustion .
RESULTS	Relaxed G tolerance was 13 % higher under the caffeinated energy drink session , whereas SACM duration did not differ among the drink conditions .
RESULTS	Hip adductor muscle strength was 37 % lower during the placebo session than during the other two sessions .
CONCLUSIONS	Consumption of a caffeine-based energy drink may enhance relaxed G tolerance and may increase strength , but does not impact acceleration tolerance duration .

###22931620
OBJECTIVE	To investigate the effect of perioperative application of intestinal probiotics to substitute oral intestinal antimicrobial agents on intestinal flora and immune function in surgical patients with colorectal cancer .
METHODS	Sixty patients with colorectal cancer undergoing elective laparoscopic radical surgery were randomized to receive preoperative bowel preparation using oral intestinal antimicrobial agents ( n = 20 ) or using oral intestinal probiotics ( Jinshuangqi Tablets , 2.0 g , 3 times daily ) since the fifth day before the operation and at 24 h after the operation for 7 consecutive days .
METHODS	Upon admission and 7 days after the operation , fecal samples and fasting peripheral venous blood were collected from the patients to examine the intestinal flora and serum levels of interleukin-2 ( IL-2 ) , IgA , IgG , and IgM , NK cell activity , T lymphocytes subsets CD3 ( + ) , CD4 ( + ) , CD8 ( + ) and CD4 ( + ) / CD8 ( + ) ratio .
RESULTS	At 7 days after the operation , the patients receiving probiotics showed significantly increased counts of intestinal Bifidobacterium , Lactobacillus , and Enterococcus ( P < 0.05 ) and significantly lowered counts of Escherichia coli and Staphylococcus aureus ( P < 0.05 ) .
RESULTS	The serum levels of IL-2 , IgA , IgG and IgM as well as CD4 ( + ) cell percentage all increased significantly in probiotics group compared with those in patients with conventional intestinal preparation ( P < 0.05 ) .
CONCLUSIONS	Perioperative application of intestinal probiotics to replace preoperative oral intestinal antimicrobial agents can effectively correct intestinal flora imbalance and improve the immune function of surgical patients with colorectal cancer .

###23980808
OBJECTIVE	We evaluated the safety and effectiveness of the Resolute zotarolimus-eluting stent ( R-ZES ) in real-world clinical practice through 3 years .
BACKGROUND	A randomized comparison of the R-ZES and the XIENCE V everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers .
BACKGROUND	RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice .
METHODS	RESOLUTE International is a single arm , observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria .
METHODS	The primary end-point was the composite of cardiac death and target vessel myocardial infarction ( TV-MI ) at 1 year .
METHODS	Secondary end-points include target lesion failure ( TLF ) , target vessel revascularization ( TVR ) , and their components , and stent thrombosis ( ST ) .
RESULTS	At 3 years 97.2 % of patients completed clinical follow-up .
RESULTS	The mean age was 63.411.2 years , 77.8 % were male , and 30.4 % had diabetes .
RESULTS	The average number of stents per patient was 1.61.0 ; and mean stent length was 30.920.5 mm .
RESULTS	Dual antiplatelet therapy was used in 91.1 % of patients at 1 year , 43.0 % at 2 years , and 34.6 % at 3 years .
RESULTS	Cardiac death and TV-MI occurred in 161 patients ( 7.0 % ) .
RESULTS	There were 6 ( 0.3 % ) very late ST events for a total ST rate of 1.1 % through 3 years .
RESULTS	The rates of clinically driven target lesion revascularization ( TLR ) , TVR , and TLF were 5.7 % , 7.4 % , and 11.4 % , respectively .
CONCLUSIONS	The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials .

###8181198
OBJECTIVE	To study the pharmacodynamic effects of intravenous temazepam after different infusion rates to pseudo steady-state concentrations .
METHODS	This was a randomized , double-blind , placebo-controlled crossover study in an academic department of clinical pharmacology .
METHODS	Subjects were nine healthy volunteers .
METHODS	A computerized infusion pump was used to obtain target plasma concentrations of temazepam after 30 or 120 minutes and to maintain these levels for 2 hours .
METHODS	A vehicle infusion , similar to the 30-minute ( fast ) infusion was used as a placebo control .
METHODS	Infusion schedules were based on data obtained from individual subjects after infusion of 0.4 mg/kg temazepam in 30 minutes .
METHODS	Target plasma concentrations were chosen to induce subhypnotic effects and averaged ( + / - SD ) 597 + / - 123 ng/ml .
METHODS	Venous plasma concentrations of temazepam were measured by HPLC .
METHODS	Free fractions of temazepam were assessed at the start of the pseudo steady-state concentration intervals .
METHODS	Electroencephalogram alpha and beta amplitudes , saccadic peak velocity , and saccadic latency were used as pharmacodynamic parameters .
RESULTS	The rate of change of plasma concentrations averaged 21 + / - 4 ng/ml .
RESULTS	min-1 during fast infusion and 5 + / - 1 ng/ml .
RESULTS	min-1 during slow infusion of temazepam .
RESULTS	Average pseudo steady-state concentrations were 639 + / - 132 ng/ml after fast infusion and 629 + / - 133 ng/ml after slow infusion .
RESULTS	At the onset of pseudo steady-state concentration intervals the average free fractions of temazepam were 44 % ( 95 % confidence interval , 19 % to 61 % ) lower for slow than for fast infusions .
RESULTS	Compared with the slow infusion , electroencephalogram beta amplitudes were significantly larger during the first 30 minutes of pseudo steady-state concentration after fast infusion of temazepam .
RESULTS	No significant differences were found for the other parameters .
RESULTS	There was a slight decline of temazepam effects during the pseudo steady-state concentration intervals for all parameters after the fast infusion and for saccadic peak velocity and saccadic latency after the slow infusion .
CONCLUSIONS	The pharmacodynamic effects of intravenous temazepam may depend partly on the rate of administration .
CONCLUSIONS	Differences in pharmacodynamic effects after fast and slow infusions could be caused by changes in protein binding over time .

###11731898
OBJECTIVE	Nonmechanical trephination has been established as an advantageous procedure in penetrating keratoplasty ( PK ) for avascular corneal diseases and has been performed successfully in more than 1000 eyes at our institution .
OBJECTIVE	The purpose of this study was to compare incidence , type and reversibility of immunological graft reactions after mechanical and nonmechanical trephination for PK .
METHODS	As part of a prospective randomized clinical trial 179 eyes of 76 females and 103 males were included , that had primary central PK without previous intraocular surgery between 10/1992 and 12/1997 for Fuchs ' dystrophy ( diameter 7.5 mm , n = 73 ) or keratoconus ( 8.0 mm , n = 106 ) .
METHODS	The recipient and donor trephinations were performed from the epithelial side using either a motor trephine ( Microkeratron , Geuder , n = 91 ) or an 193-nm excimer laser ( MEL60 , Aesculap-Meditec , 1.5 x 1.5 mm spot mode , 16 - 24 mJ/pulse , repetition rate 25/s ) along round metal masks with 8 `` orientation teeth/notches '' ( n = 88 ) .
METHODS	As a routine , donor oversize was 0.1 mm .
METHODS	128 patients ( 72 % ) had PK only , 51 patients had simultaneous cataract extraction and PC-IOL implantation ( triple procedure ) .
METHODS	Wound closure was achieved using a 16-bite double running diagonal suture by one surgeon ( G.O.H.N. ) .
METHODS	In 53 % of procedures short-term-preserved donor tissue , in 47 % organ-cultured tissue was used .
METHODS	The mean patient/donor age was 51 + / - 17/57 + / - 19 years with nonmechanical trephination and 50 + / - 19/58 + / - 20 years with mechanical trephination .
METHODS	Incidence , type and reversibility of endothelial immunologic graft reactions were recorded continuously by clinical follow-up in an outpatient service with cornea specialization ( after 6 weeks , then every 3 months until after suture removal , then every half year ) .
RESULTS	During a mean follow-up of 40 + / - 15 months , 7.3 % of eyes developed an immunological endothelial graft reaction .
RESULTS	Acute diffuse ( 5.6 % ) were more frequent than chronic focal reactions ( 1.7 % ) .
RESULTS	Only 1.7 % of grafts became irreversibly cloudy .
RESULTS	More than 80 % of all graft reactions occurred later than one year ( on average 23 + / - 13 months ) after PK .
RESULTS	Neither incidence ( p = 0.82 , Chi square test ) nor cumulative 3-year-rate of immunological graft reactions ( p = 0.91 , LogRank test ) differed significantly comparing nonmechanical ( 6.8 % or 7.3 % ) and mechanical ( 7.7 % or 5.6 % ) trephination .
RESULTS	In eyes with keratoconus ( 6.6 % , 16 + / - 8 months ) graft reactions did not occur more frequently ( p = 0.68 ) but earlier ( p = 0.02 ) than in eyes with Fuchs ' dystrophy ( 8.2 % , 31 + / - 11 months ) .
RESULTS	Donor age , post-mortem-time and preservation period did not significantly affect the rate of graft reactions in our study setting .
CONCLUSIONS	Besides well-established optical advantages , nonmechanical trephination using the excimer laser seems to have no immunologic drawbacks in contrast to conventional mechanical trephination .
CONCLUSIONS	Donor parameters appear to have no major impact on the incidence of graft reactions after non-high-risk PK .
CONCLUSIONS	Rather , an adequate postoperative therapy with topical steroids , an informed patients ' compliance , a consequent long-term follow-up in a clinical out-patient service with corneal specialization and a good education of and cooperation with the referring ophthalmologists are of utmost importance for the clear corneal graft in the long run .

###11374698
OBJECTIVE	Although percutaneous liver biopsy ( PLB ) can be a painful procedure , common practice has not included intravenous sedation or analgesia .
OBJECTIVE	Patient-administered nitrous oxide/oxygen ( N2O/O2 ) inhalation has demonstrated analgesic efficacy in various procedures associated with mild to moderate pain .
OBJECTIVE	The aim of this study was to investigate the safety and efficacy of analgesia with N2O/O2 inhalation for PLB .
METHODS	One hundred consecutive patients undergoing a first PLB ( for chronic hepatitis C : 56 , for alcoholic liver disease : 23 , for miscellaneous reasons : 21 ) .
METHODS	Patients were randomly assigned to self-administrate from a facial mask with a demand valve , for 5 min before and during biopsy , either a breathing mixture of 50 % N2O/O2 ( N2O group , n = 51 ) , or a breathing oxygen placebo ( P group , n = 49 ) .
METHODS	Liver biopsy was performed at bedside after adequate local anesthesia with xylocaine .
METHODS	At the end of the procedure , patients were asked to self-evaluate pain experienced using a visual analogue scale ( VAS ) with scoring from 0 to 100 mm .
RESULTS	N2O/O2 administration resulted in the absence of pain in a significantly higher number of patients treated than in patients of the P group : 19 versus 2 , respectively ( p = 0.0001 ) .
RESULTS	Patients receiving N2O/O2 had significantly lower pain scores than those of the P group : 12 + / -12 versus 28 + / -19 mm ( p < 0.0001 ) .
RESULTS	No serious complication was observed .
RESULTS	Side effects of N2O/O2 were minor and reversible .
RESULTS	The average cost per biopsy was 4 US dollars .
CONCLUSIONS	Patient-administered N2O/O2 inhalation provides safe and effective analgesia , at a reasonable cost , for PLB .
CONCLUSIONS	Its routine use could be useful for the management of patients with chronic liver disease undergoing PLB as it may enhance patients compliance with future biopsies .

###23629959
OBJECTIVE	Sleep disturbances are a core and salient feature of posttraumatic stress disorder ( PTSD ) .
OBJECTIVE	Pilot studies have indicated that combined cognitive-behavioral therapy for insomnia ( CBT-I ) and imagery rehearsal therapy ( IRT ) for nightmares improves sleep as well as PTSD symptoms .
METHODS	The present study randomized 40 combat veterans ( mean age 37.7 years ; 90 % male and 60 % African American ) who served in Afghanistan and/or Iraq ( Operation Enduring Freedom [ OEF ] / Operation Iraqi Freedom [ OIF ] ) to 4 sessions of CBT-I with adjunctive IRT or a waitlist control group .
METHODS	Two thirds of participants had nightmares at least once per week and received the optional IRT module .
RESULTS	At posttreatment , veterans who participated in CBT-I/IRT reported improved subjectively and objectively measured sleep , a reduction in PTSD symptom severity and PTSD-related nighttime symptoms , and a reduction in depression and distressed mood compared to the waitlist control group .
CONCLUSIONS	The findings from this first controlled study with OEF/OIF veterans suggest that CBT-I combined with adjunctive IRT may hold promise for reducing both insomnia and PTSD symptoms .
CONCLUSIONS	Given the fact that only half of the patients with nightmares fully implemented the brief IRT protocol , future studies should determine if this supplement adds differential efficacy to CBT-I alone .

###17597827
OBJECTIVE	We wished to compare the efficacy of light-emitting diode ( LED ) phototherapy with special blue fluorescent ( BB ) tube phototherapy in the treatment of neonatal hyperbilirubinemia .
METHODS	We randomly assigned 66 infants > or = 35 weeks of gestation to receive phototherapy using an LED device or BB .
METHODS	In addition to phototherapy from above , all infants also received phototherapy from below using four BB tubes or a fiberoptic pad .
RESULTS	After 15 + / -5 h of phototherapy , the rate of decline in the total serum bilirubin ( TSB ) was 0.35 + / -0.25 mg/dl/h in the LED group vs 0.27 + / -0.25 mg/dl/h in the BB group ( P = 0.20 ) .
CONCLUSIONS	LED phototherapy is as effective as BB phototherapy in lowering serum bilirubin levels in term and near-term newborns .

###21841500
OBJECTIVE	In patients with type 2 diabetes mellitus ( T2DM ) , blocking of the renin-angiotensin-aldosterone system ( RAAS ) has demonstrated efficacy in lowering blood pressure ( BP ) and urinary albumin excretion rate ( UAER ) .
OBJECTIVE	Nonetheless , not all patients successfully respond to RAAS blockade with a reduction in BP and UAER .
METHODS	This secondary analysis of a double-blind study of 391 patients with T2DM assessed the importance of using higher doses of the RAAS blocker valsartan to improve the BP and UAER response in patients initially identified as prompt or delayed responders .
METHODS	All patients received a starting dose of valsartan 160mg for a 4-week run-in period to classify them as either prompt responders ( SBP < 130mmHg or reduction in SBP10mmHg , 53 % ) or delayed responders ( 47 % ) .
METHODS	All patients were then subsequently randomized to one of three valsartan doses : 160 , 320 , or 640mg/day for 26 weeks .
RESULTS	Higher doses of valsartan ( 640mg ) demonstrated additional reductions in SBP among the prompt responders and led to greater SBP reductions from baseline ( 19.8 mmHg ) compared with valsartan 160 ( 14.4 mmHg , P < 0.05 ) and 320mg ( 16.5 mmHg ) .
RESULTS	Among delayed responders , SBP reductions from baseline to end of study were similar ( 11-14mmHg , P > 0.05 ) across all valsartan doses .
RESULTS	For UAER , higher valsartan doses produced further reductions by week 30 , regardless of initial response .
CONCLUSIONS	Higher doses of valsartan did not appear to recruit delayed responders , but enhanced the prompt responder effects in patients with T2DM .
CONCLUSIONS	Not all patients successfully respond in concordance to RAAS blockade with both reductions in BP and UAER .
CONCLUSIONS	Reduction in BP dominates the antialbuminuric effect in both valsartan prompt responders and delayed responders independent of dose .

###20019315
OBJECTIVE	We assessed change in fruit and vegetable intake in a population-based sample , comparing an online untailored program ( arm 1 ) with a tailored behavioral intervention ( arm 2 ) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail ( arm 3 ) .
METHODS	We conducted a randomized controlled intervention trial , enrolling members aged 21 to 65 years from 5 health plans in Seattle , Washington ; Denver , Colorado ; Minneapolis , Minnesota ; Detroit , Michigan ; and Atlanta , Georgia .
METHODS	Participants reported fruit and vegetable intake at baseline and at 3 , 6 , and 12 months .
METHODS	We assessed mean change in fruit and vegetable servings per day at 12 months after baseline , using a validated self-report fruit and vegetable food frequency questionnaire .
RESULTS	Of 2540 trial participants , 80 % were followed up at 12 months .
RESULTS	Overall baseline mean fruit and vegetable intake was 4.4 servings per day .
RESULTS	Average servings increased by more than 2 servings across all study arms ( P < .001 ) , with the greatest increase ( +2.8 servings ) among participants of arm 3 ( P = .05 , compared with control ) .
RESULTS	Overall program satisfaction was high .
CONCLUSIONS	This online nutritional intervention was well received , convenient , easy to disseminate , and associated with sustained dietary change .
CONCLUSIONS	Such programs have promise as population-based dietary interventions .

###10334254
BACKGROUND	Wound complications that occur after closure of midline laparotomy remain challenging .
BACKGROUND	A new continuous double-loop closure ( CDLC ) technique was developed to avoid wound rupture through resistance to high intra-abdominal pressure and continued approximation of wound edges .
BACKGROUND	We investigated the efficacy of this technique .
METHODS	We randomly assigned 390 patients undergoing midline laparotomy-wound closure with the commonly used continuous running suture ( CRS ) technique ( n = 204 ) or with the CDLC technique ( n = 186 ) .
METHODS	We assessed the influence of closure technique on the rate of wound and other complications , with emphasis on wound dehiscence , pulmonary complications , and death .
RESULTS	The rate of wound complications did not differ significantly between groups .
RESULTS	Pulmonary complications were seen in 11 patients ( 5.4 % ) in the CRS group , and in 32 patients ( 17.2 % ) in the CDLC group ( p = 0.0002 ) .
RESULTS	In the CRS group , 17 ( 8.3 % ) patients died , compared with 39 ( 21.0 % ) patients in the CDLC group ( p = 0.0004 ) .
CONCLUSIONS	The CDLC technique should not be used .
CONCLUSIONS	The lessened compliance of the abdominal wall , which raises intra-abdominal pressure for long periods , may increase the risk of postoperative pulmonary complications and death .
CONCLUSIONS	The ideal closure technique should combine strength to prevent wound rupture with elasticity to adapt to increased intra-abdominal pressure .

###14572126
OBJECTIVE	To determine the therapeutic efficacy and viability of a novel oral interface for continuous positive airway pressure ( CPAP ) compared with conventional nasal interfaces .
METHODS	A randomized single-blind crossover study .
METHODS	Hospital-based sleep laboratory .
METHODS	21 CPAP-nave patients with obstructive sleep apnea ( baseline apnea-hypopnea index , 85 + / - 36 ) INTERVENTIONS : Nasal CPAP and oral CPAP MEASUREMENTS AND RESULTS : Patients were each treated for two 4-week periods using nasal CPAP and oral CPAP .
METHODS	The CPAP titrations were undertaken at the start of each treatment arm .
METHODS	Outcome measures were recorded at baseline and at the end of each treatment arm .
METHODS	These included polysomnography variables , CPAP compliance , subjective sleepiness , obstructive sleep apnea symptom ratings , and adverse effects .
METHODS	There were no significant differences between oral and nasal interfaces for the on-CPAP frequency of apneas and hypopneas ( mean difference , nasal-oral [ 95 % CI ] = -4.6 [ -10.1 -1.0 ] / h ; P = 0.06 ) or arousals ( -3.0 [ -7.8 -1.8 ] / h ; P = 0.23 ) .
METHODS	There were also no statistically significant differences between interfaces for scores on the Epworth Sleepiness Scale ( -0.7 [ -3.1 -1.7 ] ; P = 0.20 ) , obstructive sleep apnea symptoms ( -7.7 [ -17.7 -2.4 ] ; P = 0.052 ) , CPAP compliance ( 0.3 [ -0.5 -1.1 ] h/night ; P = 0.50 ) , CPAP pressure ( 0.05 [ -0.66 -0.76 ] cmH20 ; P = 0.73 ) , CPAP side effects scores ( -2.0 [ -5.3 -1.4 ] ; P = 0.23 ) , or mask preference ( P = 0.407 ) .
METHODS	In addition , both nasal and oral interfaces significantly improved polysomnographic variables , Epworth Sleepiness Scale scores , obstructive sleep apnea symptoms , and CPAP compliance from baseline ( all P < 0.05 ) .
CONCLUSIONS	This preliminary study indicates that oral CPAP has similar efficacy to traditionally applied nasal CPAP in treating obstructive sleep apnea .
CONCLUSIONS	Additional large studies are required to determine the range of clinical situations where oral CPAP is indicated .

###8968156
OBJECTIVE	To evaluate the tuberculin reactivity among medical students and the utility of RT-23 ( 2 tuberculin unit [ TU ] purified protein derivative [ PPD ] ) produced in Mexico .
METHODS	A blind and comparative study was conducted in a school of medicine using simultaneously RT-23 and an American product ( 5 TU PPD ) randomly assigned to each forearm and read 48 hours later .
METHODS	Ninety eight volunteers were included , 69 from the first year and 29 from the fifth year as medical students .
RESULTS	Using 5 TU PPD , 16 % of first year students and 41 % of fifth grade students were positive ( induration > or = 10 mm ) .
RESULTS	The RT-23 worked well and showed a sensitivity of 87 % and a specificity of 92 % .
RESULTS	There was a large difference in the positivity of fifth versus first year students ( x2 = 6.00 , P = 0.014 ) with an estimated annual conversion of 5.1 % .
RESULTS	The high tuberculin conversion rate urges the need to establish preventive and early diagnosis programs for tuberculosis .
RESULTS	The utility of RT-23 was found to be comparable to 5 TU PPD in our population .

###7479627
BACKGROUND	The cost of diabetes mellitus can be defined in both medical and economic terms .
BACKGROUND	Although there is an abundance of literature concerning the medical management of diabetes , few studies have assessed the financial impact of its treatment .
BACKGROUND	This study examined the savings in prescription costs associated with a weight reduction program for obese men and women with non-insulin-dependent diabetes mellitus ( NIDDM ) .
METHODS	Forty subjects ages 40-70 years who had body mass indexes of 30-40 kg/m2 and NIDDM of more than 1 year duration were assigned to one of two 800-kcal weight-loss programs for 12 weeks .
METHODS	A cost analysis was done on the 32 subjects who were taking anti-hypertensive and/or anti-diabetes medications .
METHODS	A list of medications and monthly amounts was obtained at the start , upon completion , and 1 year following completion of the diet .
METHODS	The average out-of-pocket cost for a month 's supply of each prescription was calculated by polling 16 retail pharmacies in Lexington , Kentucky .
RESULTS	Subjects lost an average of 15.3 kg ( 33.7 lb ) over the 12 weeks .
RESULTS	At 1-year follow-up , subjects maintained a mean 9.0-kg ( 19.8 lb ) weight loss .
RESULTS	The average monthly prediet out-of-pocket cost for anti-hypertensive and anti-diabetes medications and supplies was $ 63.30 per subject .
RESULTS	Following completion of the diet , this cost per month decreased to $ 20.40 and at 1-year follow-up the average monthly cost per subject was $ 32.40 .
RESULTS	The estimated average savings in prescription costs per subject over the year was $ 442.80 .
CONCLUSIONS	Significant short - and long-term savings in prescription costs were obtained following a 12-week hypocaloric weight reduction program for obese individuals with NIDDM .

###19680473
BACKGROUND	Limited evidence suggests that rizatriptan given before vestibular stimulation reduces motion sickness in persons with migraine-related dizziness .
BACKGROUND	The present study was designed to test whether rizatriptan is also effective in protecting against visually-induced motion sickness and to test whether rizatriptan blocks the augmentation of motion sickness by head pain .
METHODS	Using randomized double-blind , placebo-controlled methodology , 10 females , 6 with migrainous vertigo ( V + ) and four without vertigo ( V - ) received 10 mg rizatriptan or placebo two hours prior to being stimulated by optokinetic stripes .
METHODS	Visual stimulation was coupled with three pain conditions : no pain ( N ) , thermally-induced hand pain ( H ) and temple pain ( T ) .
METHODS	Motion sickness and subjective discomfort were measured .
RESULTS	Motion sickness was less after pre-treatment with rizatriptan for 4 of 10 subjects and more for 5 of 10 subjects .
RESULTS	Augmentation of motion sickness by head pain was seen in 6 of 10 subjects ; this effect was blunted by rizatriptan in 4 of these 6 subjects .
RESULTS	Subjective discomfort was significantly more noticeable in V + subjects as compared with V - subjects .
CONCLUSIONS	These pilot data suggest that rizatriptan does not consistently reduce visually-induced motion sickness in migraineurs .
CONCLUSIONS	Rizatriptan may diminish motion sickness potentiation by cranial pain .

###12221346
METHODS	A randomized controlled trial in occupational health practice was conducted .
OBJECTIVE	To study the efficacy of early management of workers with low back pain by occupational physicians , as compared with management by the supervisor only .
BACKGROUND	Health care and university workers with back pain and on sick leave for less than 1 month were included in the study .
METHODS	Patients with low back pain for at least 10 days on sick leave were randomly assigned to early management by the occupational physician ( n = 61 ) or to a reference group with management by the worker 's supervisor during the first 3 months of sick leave ( n = 59 ) .
METHODS	The patients were observed for 1 year and compared in terms of time until return to work , pain intensity , functional disability , and general health perception .
METHODS	The occupational physicians were provided with management guidelines .
RESULTS	No significant differences were found after 3 and 12 months of follow-up evaluation in terms of time until return to work ( hazard ratio , 1.3 ; 95 % CI , 0.90-1 .90 ) or in terms of other health outcomes .
RESULTS	Recurrences , however , occurred more frequently in the intervention group , but the total duration of sick leave in 1 year did not differ between the groups .
CONCLUSIONS	The findings do not show a significant positive effect of an early intervention by occupational physicians on workers with low back pain .
CONCLUSIONS	This might reflect the early phase of disability or the low intensity of the intervention resulting from overestimation of the physicians ' compliance with the guidelines .

###19092242
OBJECTIVE	To assess the influence of acute hypoxemia on the dimensions of diseased and nondiseased coronary arterial segments in humans .
METHODS	In 18 subjects ( age 53 + / - 8 years ) with known or suspected coronary artery disease , quantitative coronary angiography was performed before and after being randomly assigned to breathing ( 1 ) an inspired oxygen concentration ( fraction of inspired oxygen , FIO2 ) of 21 % ( room air , RA ) for 20 min ( n = 4 , controls ) or ( 2 ) an FIO2 of 15 and 10 % for 10 min each ( corresponding to altitudes of 2,500 and 5,500 m , respectively ; n = 14 ) .
RESULTS	In the control subjects , no hemodynamic , oximetric or angiographic variable changed .
RESULTS	In the 14 study subjects , the arterial partial pressure of oxygen averaged 85 + / - 13 mm Hg on RA , 65 + / - 15 mm Hg on 15 % FIO2 and 44 + / - 13 mm Hg on 10 % FIO2 .
RESULTS	Average arterial segment diameter was 2.52 + / - 0.63 mm on RA , 2.55 + / - 0.62 mm on 15 % FIO2 ( not significant vs. RA ) and 2.66 + / - 0.66 mm on 10 % FIO2 ( p < 0.001 vs. RA ) .
RESULTS	The increase in coronary arterial diameter with 10 % FIO2 occurred only in normal segments ( 2.74 + / - 0.64 vs. 2.97 + / - 0.64 mm ; p < 0.001 ) , but not in diseased segments ( 2.34 + / - 0.57 vs. 2.38 + / - 0.55 mm ; not significant ) .
CONCLUSIONS	In humans , severe hypoxemia induces vasodilation of angiographically normal coronary arterial segments , whereas it causes no change in diseased segments .

###19809412
OBJECTIVE	Gastroesophageal reflux disease ( GERD ) is a chronic condition that usually requires long-term maintenance therapy with proton-pump inhibitors ( PPIs ) .
OBJECTIVE	In clinical practice , patients receive PPIs at the lowest dose to control symptoms .
OBJECTIVE	However , it is not known whether this approach adequately controls acidic esophageal reflux .
OBJECTIVE	We sought to investigate the efficacy of three different dosages of esomeprazole in patients receiving maintenance therapy for GERD , using the Bravo pH system .
METHODS	Patients with a previous history of erosive esophagitis A or B ( LA classification ) that was healed at the time of enrollment or endoscopy-negative reflux disease ( ENRD ) , documented with an abnormal pH study , were randomized to receive maintenance therapy with esomeprazole 40 mg twice daily ( group A ) , once daily ( group B ) , or every other day ( group C ) .
METHODS	Intraesophageal pH was monitored for two consecutive days using the Bravo wireless system , 30 days after randomization .
METHODS	The parameters subjected to analysis were percent of total time pH < 4 and the De Meester score .
RESULTS	The pH results from 73 patients ( group A = 24 , group B = 24 , group C = 25 patients ) were subjected to final analysis .
RESULTS	On the first day of the study , the mean ( + / - s.d. ) percent of total time pH < 4 and the De Meester score were group A : 0.9 ( 1.2 ) and 4.1 ( 4.0 ) ; group B : 1.5 ( 1.6 ) and 7.0 ( 6.9 ) ; group C : 1.3 ( 1.0 ) and 6.0 ( 3.3 ) , respectively ( P = 0.262 and 0.134 , respectively ) .
RESULTS	On the second day of the study , the corresponding values were group A : 0.7 ( 1.0 ) and 3.9 ( 5.9 ) ; group B : 1.5 ( 1.8 ) and 6.4 ( 6.6 ) ; group C : 7.0 ( 4.4 ) and 29.4 ( 19.4 ) , respectively .
RESULTS	The difference was statistically significant ( P < 0.0001 and < 0.0001 , respectively ) .
RESULTS	Further analysis showed that patients not receiving PPI had a significantly higher mean percent of total time pH < 4 and De Meester score as compared with patients on PPI once or twice daily ( P < 0.001 and < 0.001 respectively ) .
CONCLUSIONS	The administration of esomeprazole 40 mg every other day does not control acidic esophageal reflux on the day off PPI .
CONCLUSIONS	Esomeprazole 40 mg once daily effectively controls reflux of acid in patients with history of mild esophagitis or ENRD , whereas doubling the dose does not seem to confer any further advantage .

###19301515
OBJECTIVE	The objective of these two six-week , double-blind clinical studies was to compare the extrinsic stain prevention ( Study # 1 ) and stain removal ( Study # 2 ) efficacy of a new dentifrice ( Colgate Total Advanced Toothpaste ) containing 0.3 % triclosan / 2.0 % polyvinylmethyl ether/maleic acid ( PVM/MA ) copolymer/0 .243 % sodium fluoride in a 17 % dual silica base , to a commercially available fluoride dentifrice without tooth whitening ingredients ( Crest Cavity Protection Toothpaste ) containing 0.243 % sodium fluoride in a silica base .
METHODS	Following baseline examinations for extrinsic tooth stain and an oral tissue examination , qualifying adult male and female subjects from the northern and central New Jersey , USA areas were randomized for each study into two treatment groups which were balanced for gender and level of extrinsic tooth stain .
METHODS	Subjects received a full oral prophylaxis at the start of Study # 1 only .
METHODS	All subjects were provided with their assigned product and a soft-bristled adult toothbrush for home use .
METHODS	Subjects were instructed to brush their teeth for one minute twice daily ( morning and evening ) using only the dentifrice and toothbrush provided , and to refrain from using any other oral hygiene products for the entire six weeks of the study .
METHODS	There were no restrictions regarding diet or smoking habits during the course of the study .
METHODS	Examinations for extrinsic tooth stain and oral tissue assessments were repeated after three weeks and six weeks of product use .
RESULTS	One-hundred fourteen ( 114 ) subjects participating in Study # 1 and 119 subjects participating in Study # 2 complied with the protocol and completed the entire study .
RESULTS	In both studies , at the three-week and the six-week examinations , subjects who used the new dentifrice exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects who used the commercially available fluoride control dentifrice .
CONCLUSIONS	A new dentifrice containing 0.3 % triclosan/2 .0 % PVM/MA copolymer/0 .243 % sodium fluoride in a 17 % dual silica base is more efficacious in the prevention and removal of extrinsic tooth stain than a commercially marketed fluoride dentifrice .

###22752384
BACKGROUND	Translational research implicates the mu opioid neurochemical system in hedonic processing , but its role in dissociable high-level cognitive functions is not well understood .
BACKGROUND	Binge-eating represents a useful model of ` behavioural addiction ' for exploring this issue .
OBJECTIVE	The aim of this study was to objectively assess the cognitive effects of a mu opioid receptor antagonist in obese individuals with binge-eating symptoms .
METHODS	Adults with moderate to severe binge-eating and body mass index 30 kg/m received 4 weeks of treatment with a mu opioid receptor antagonist ( GSK1521498 ) 2 or 5 mg per day , or placebo , in a double-blind randomised parallel design .
METHODS	Neuropsychological assessment was undertaken at baseline and endpoint to quantify processing bias for food stimuli ( visual dot probe with 500 - and 2,000-ms stimulus presentations and food Stroop tasks ) and other distinct cognitive functions ( N-back working memory , sustained attention , and power of attention tasks ) .
RESULTS	GSK1521498 5 mg/day significantly reduced attentional bias for food cues on the visual dot probe task versus placebo ( p = 0.042 ) , with no effects detected on other cognitive tasks ( all p > 0.10 ) .
RESULTS	The effect on attentional bias was limited to the longer stimulus duration condition in the higher dose cohort alone .
CONCLUSIONS	These findings support a central role for mu opioid receptors in aspects of attentional processing of food cues but militate against the notion of major modulatory influences of mu opioid receptors in working memory and sustained attention .
CONCLUSIONS	The findings have implications for novel therapeutic directions and suggest that the role of different opioid receptors in cognition merits further research .

###12066723
BACKGROUND	Coronary artery bypass grafting with hypothermic cardiac arrest and cardiopulmonary bypass ( CPB ) is associated with myocardial injury .
BACKGROUND	Our study investigated whether an infusion of glucose , insulin and potassium ( GIK ) during elective coronary artery bypass surgery decreases myocardial cell death .
METHODS	We measured cardiac troponin I ( cTnI ) , a myofibrillar structural protein , which is a sensitive and specific indicator of myocytic injury .
METHODS	With ethics committee approval , 42 patients were enrolled into a randomized , prospective , double-blinded study .
METHODS	In the GIK group , 500 ml of 50 % dextrose solution containing 100 IU insulin and potassium 80 mmol was infused at the rate of 0.75 ml kg ( -1 ) h ( -1 ) .
METHODS	Patients in the non-GIK group received 5 % dextrose solution at the same rate .
METHODS	Arterial blood samples were taken before induction of anaesthesia , after removal of the aortic clamp and 6 and 12 h after CPB .
RESULTS	In both groups there was an increase in cTnI concentration ( P < 0.05 ) , which was greatest about 6 h after CPB .
RESULTS	At no time did the cTnI concentration differ between the two groups .
CONCLUSIONS	The results suggest that GIK does not decrease the irreversible myocardial damage associated with routine coronary artery bypass surgery .

###20383847
OBJECTIVE	To compare the effects of topical antiallergic eyedrops in relieving the signs and symptoms of patients with allergic conjunctival pathology .
METHODS	In this multicenter , single-masked , randomized study , 240 patients with signs and symptoms of allergic conjunctivitis were randomized to receive 1 of the following 8 treatments twice daily : cromolyn sodium/chlorpheniramine maleate , diclofenac , epinastine , fluorometholone , ketotifen , levocabastine , naphazoline/antazoline , and olopatadine .
METHODS	Clinical signs and symptoms were evaluated by a masked operator using a 10-point scale at the moment of enrollment ( day 0 ) and at weeks 1 , 2 , and 4 .
METHODS	The percentage of patients achieving at least a small ( at least 50 % reduction of the total scale score ) or a good ( at least 75 % ) improvement of signs and symptoms was calculated at each visit .
METHODS	Tolerability was also evaluated as the duration of discomfort after instillation .
RESULTS	All drugs gave some improvement in symptoms in more than 85 % of cases .
RESULTS	Epinastine and olopatadine obtained at least a good relief of symptoms in 37 % and 33 % of cases at week 1 .
RESULTS	At the end of the study , good improvement of symptoms was obtained in at least 70 % of patients by epinastine , ketotifen , fluorometholone , and olopatadine , whereas a 75 % improvement for signs was obtained only by fluorometholone and ketotifen .
RESULTS	Naphazoline/antazoline induced higher discomfort compared to the other study treatments ( p < 0.0001 ) .
CONCLUSIONS	The efficacy of epinastine , ketotifen , and olopatadine in the treatment of allergic conjunctivitis was comparable to fluorometholone .
CONCLUSIONS	Naphazoline/antazoline had lower tolerability than the other study treatments .

###12385079
OBJECTIVE	To compare the efficacy of a psychodynamic psychotherapy group ( PPG ) and a cognitive-behavior group ( CBG ) for male veterans with a history of assault .
METHODS	Data collected included the Addiction Severity Index , the Overt Aggression Scale , and the State-Trait Anger Expression Inventory .
METHODS	Subjects ( N = 27 ) were assigned randomly to a central group , PPG , or CBG .
METHODS	Analyses included an overall comparison of the groups as well as repeated-measures analyses and adjustments for covariates .
RESULTS	The PPG showed a trend toward improvement of overt aggression and significant improvement of trait aggression compared with CBG .
RESULTS	There were no differences in state aggression or efforts to control aggression .
CONCLUSIONS	Both the PPG and CBG are effective treatments for aggression .

###12574761
OBJECTIVE	We sought to determine the effectiveness in decreasing some symptoms , such as vertigo , and increasing performance of daily life skills after vestibular rehabilitation .
METHODS	Patients who had chronic vertigo due to peripheral vestibular impairments were seen at a tertiary care center .
METHODS	They were referred for vestibular rehabilitation and were assessed on vertigo intensity and frequency with the use of the Vertigo Symptom Scale , the Vertigo Handicap Questionnaire , the Vestibular Disorders Activities of Daily Living Scale , and the Dizziness Handicap Inventory .
METHODS	They were then randomly assigned to 1 of 3 home program treatment groups .
RESULTS	Vertigo decreased and independence in activities of daily living improved significantly .
RESULTS	Improvement was not affected by age , gender , or history of vertigo .
CONCLUSIONS	For many patients a simple home program of vestibular habituation head movement exercises is related to reduction in symptoms and increasing independence in activities of daily living .

###9753527
BACKGROUND	Salmeterol is a potent long acting beta-agonist that is effective in relieving the symptoms and airflow limitation of asthma .
OBJECTIVE	To determine whether the effect of salmeterol on clinical parameters in a mild eosinophilic exacerbation of asthma was similar to that of beclomethasone dipropionate ( BDP ) and , thus , is due to an anti-inflammatory property .
METHODS	Thirty-four asthmatics with a persistent increase in symptoms for at least two weeks and an increase of sputum eosinophils of 4 % or more were randomized in a double-blind fashion to one of three groups that received daily treatment with 100 mg salmeterol , 1 mg BDP or placebo in divided doses using identical pressurized inhalers .
METHODS	Patients were treated with study medications for three weeks , followed by one week of open label BDP ( 500 mg bid ) .
METHODS	Patients were seen at weekly intervals , and sputum and blood were obtained on each visit .
METHODS	The primary outcome measure was a change in sputum eosinophils , and secondary outcomes were changes in blood eosinophils , eosinophilic cationic protein ( ECP ) and clinical parameters .
METHODS	Three patients ( one in each group ) could not produce any sputum after randomization and were excluded from the analysis .
RESULTS	Twelve patients received salmeterol , 10 received BDP and nine received placebo .
RESULTS	Salmeterol treatment had no effect on sputum eosinophils geometric mean , ( from 35.5 [ 24.9 ] to 26.9 % [ 25.8 ] ) , blood eosinophils ( from 7.6 [ 4.8 ] to 7.2 % [ 3.9 ] ) or ECP ( from 33.1 [ 18.1 ] to 27.8 [ 16.3 ] mg/L ) but improved morning peak expiratory flow ( PEF ) and diurnal variation of PEF , and decreased the use of rescue medication more than placebo ( P < 0.05 for all comparisons ) .
RESULTS	In contrast , BDP improved both inflammatory indexes ( sputum eosinophils from 22.5 [ 17.9 ] to 5.7 % [ 6.8 ] , blood eosinophils from 9.0 [ 5.5 ] to 2.1 % 1.0 , and serum ECP from 36.5 [ 22.0 ] to 16.1 [ 10.1 ] mg/L ) as well as clinical parameters .
CONCLUSIONS	These results show that salmeterol improves the symptoms and airway function of patients with asthma , but has no effect on eosinophilic airway infiltration .
CONCLUSIONS	These findings support current asthma guidelines , which recommend the initial use of inhaled steroid to maximize clinical improvement .
CONCLUSIONS	While salmeterol also produces clinical improvement , it does not suppress sputum eosinophilia .
CONCLUSIONS	The analysis of induced or spontaneous sputum for inflammatory indexes may be a valuable clinical test to guide the use of inhaled steroid and/or a long acting beta-agonist .

###23063945
OBJECTIVE	The purpose of this randomized , double-blind placebo-controlled study was to evaluate the effect of nefopam , a centrally acting antinociceptive compound , on the development of hyperalgesia after sternotomy .
OBJECTIVE	Preventive strategy giving nefopam from the early stage of anesthesia was compared with a postoperative strategy only and placebo .
METHODS	This study was double-blinded and randomized .
METHODS	It was conducted in a single university hospital .
METHODS	Ninety American Society of Anesthesiologists II to III patients scheduled for elective cardiac surgery .
METHODS	Patients were assigned randomly to receive a 0.3-mg / kg bolus of nefopam at the induction of anesthesia followed by a continuous infusion of 0.065 mg/kg/h for 48 hours ( G1 ) , a 0.3-mg / kg bolus of nefopam at the end of surgery followed by a continuous infusion of 0.065 mg/kg/h for 48 hours ( G2 ) , or a placebo ( G3 ) .
METHODS	Postoperative analgesia was based on morphine patient-controlled analgesia and rescue analgesia when necessary .
METHODS	Postoperative hyperalgesia , pain scores , morphine consumption , and postoperative cognitive dysfunction were assessed for the first 48 hours and thereafter on postoperative days 4 and 7 .
RESULTS	The postoperative extent of dynamic hyperalgesia and the decrease of the nociceptive threshold evaluated by von Frey filaments at the sternal midline were smaller in group 1 and group 2 compared with the placebo group at the 24th hour .
RESULTS	The primary objective was the extent of hyperalgesia at the midline given as the mean ( standard deviation [ SD ] ) ( 4.4 [ 2.5 ] cm for G1 , 4.1 [ 2.7 ] for G2 , and 6.1 [ 2.7 ] cm for G3 .
RESULTS	The punctuate is given as mean ( SD ) ( 64 [ 43 ] g for G1 , 68 [ 40.8 ] g for G2 , and 32 [ 27 ] g for G3 ; with p < 0.05 for the comparisons of extent and punctuate hyperalgesia between G1 and G3 and G2 and G3 ) .
RESULTS	The extent of hyperalgesia was not significantly different among the 3 groups on days 2 , 4 , and 7 after surgery .
RESULTS	There were no significant differences in pain scores , morphine consumption , or postoperative cognitive dysfunctions .
CONCLUSIONS	Nefopam administered during the perioperative period slightly reduced acute hyperalgesia after cardiac surgery , but this was not associated with improved analgesic efficacy .

###24192334
BACKGROUND	A substantial portion of patients with atrial fibrillation ( AF ) also have coronary artery disease ( CAD ) and are at risk for coronary events .
BACKGROUND	Warfarin is known to reduce these events , but increase the risk of bleeding .
BACKGROUND	We assessed the effects of apixaban compared with warfarin in AF patients with and without prior CAD .
RESULTS	In ARISTOTLE , 18,201 patients with AF were randomized to apixaban or warfarin .
RESULTS	History of CAD was defined as documented CAD , prior myocardial infarction , and/or history of coronary revascularization .
RESULTS	We analyzed baseline characteristics and clinical outcomes of patients with and without prior CAD and compared outcomes by randomized treatment using Cox models .
RESULTS	A total of 6639 ( 36.5 % ) patients had prior CAD .
RESULTS	These patients were more often male , more likely to have prior stroke , diabetes , and hypertension , and more often received aspirin at baseline ( 42.2 % vs. 24.5 % ) .
RESULTS	The effects of apixaban were similar among patients with and without prior CAD on reducing stroke or systemic embolism and death from any cause ( hazard ratio [ HR ] 0.95 , 95 % confidence interval [ CI ] 0.71-1 .27 , P for interaction = 0.12 ; HR 0.96 , 95 % CI 0.81-1 .13 , P for interaction = 0.28 ) .
RESULTS	Rates of myocardial infarction were numerically lower with apixaban than warfarin among patients with and without prior CAD .
RESULTS	The effect of apixaban on reducing major bleeding and intracranial hemorrhage was consistent in patients with and without CAD .
CONCLUSIONS	In patients with AF , apixaban more often prevented stroke or systemic embolism and death and caused less bleeding than warfarin , regardless of the presence of prior CAD .
CONCLUSIONS	Given the common occurrence of AF and CAD and the higher rates of cardiovascular events and death , our results indicate that apixaban may be a better treatment option than warfarin for these high-risk patients .

###24274891
OBJECTIVE	To evaluate effects of quaternary benzo ( c ) phenanthridine alkaloids ( QBAs ) against Salmonella spp and determine effects on growth performance , organism shedding , and gastrointestinal tract integrity in pigs inoculated with Salmonella enterica serovar Typhimurium .
METHODS	36 Salmonella isolates and twenty 5-week-old pigs .
METHODS	Minimum inhibitory concentration of QBAs against the Salmonella isolates was determined .
METHODS	Pigs were allocated to 4 groups and inoculated with Salmonella organisms .
METHODS	Pigs received diets supplemented with 1.5 g of QBAs/1 ,000 kg of feed , 0.75 g of QBAs/1 ,000 kg of feed , or 59.4 g of chlortetracycline/1 ,000 kg of feed or a nonsupplemented ( control ) diet .
METHODS	Pigs were weighed on day 0 and then weekly for 40 days .
METHODS	Fecal samples were collected to quantify Salmonella organisms .
METHODS	Gastrointestinal tract integrity was evaluated by measuring transepithelial resistance .
RESULTS	In vitro , 9 of 36 ( 25 % ) Salmonella isolates were inhibited at 90 g of QBAs/mL ; all 36 were inhibited at 179 g of QBAs/mL .
RESULTS	Diets containing QBAs significantly decreased Salmonella spp shedding ; shedding was lower 40 days after inoculation for pigs fed diets containing QBAs or chlortetracycline than for pigs fed the control diet .
RESULTS	Growth performance was similar for pigs fed diets containing QBA or chlortetracycline .
RESULTS	Gastrointestinal tract integrity was improved in pigs fed the diet containing 1.5 g of QBAs/1 ,000 kg of feed .
CONCLUSIONS	QBAs and chlortetracycline decreased Salmonella spp shedding but did not differ with regard to growth performance .
CONCLUSIONS	Gastrointestinal tract integrity was better , albeit not significantly , in pigs fed diets containing QBAs .
CONCLUSIONS	Further investigation into the role of QBAs and their mechanism as an immunomodulator is necessary .

###14507560
OBJECTIVE	To evaluate the onset time , success rate , and recovery profile of unilateral spinal anesthesia produced with 4 mg , 6 mg , and 8 mg of 0.5 % hyperbaric bupivacaine .
METHODS	Prospective , randomized , blinded study .
METHODS	Outpatient anesthesia unit at a University Hospital .
METHODS	90 ASA physical status I and II outpatients , who were scheduled for elective knee arthroscopy .
METHODS	After standard intravenous midazolam premedication ( 0.05 mg/kg ) and crystalloid infusion ( 7 mL/kg ) were given , patients were placed in the lateral decubitus position on the operative side , and randomly allocated to receive spinal block with either 4 mg ( Group 4 , n = 30 ) , 6 mg ( Group 6 , n = 30 ) , or 8 mg ( Group 8 , n = 30 ) of 0.5 % hyperbaric bupivacaine injected slowly ( 3 mL/min ) with the needle orifice directed toward the dependent side using a 25-gauge Whitacre needle .
METHODS	The lateral decubitus position was maintained for 15 minutes .
RESULTS	The onset time of surgical block was 13 + / - 5 minutes in Group 4 and 10 + / - 4 minutes in Group 6 ( p = 0.006 ) , and 9 + / - 4 minutes in Group 8 ( p = 0.002 ) .
RESULTS	The maximum level of sensory block on the operative and nonoperative sides was , respectively , T ( 10 ) ( T ( 12 ) - T ( 6 ) ) and / ( / - L ( 2 ) ) in Group 4 ( p = 0.0005 ) , T ( 8 ) ( T ( 12 ) - T ( 6 ) ) and / ( / - L ( 5 ) ) in Group 6 ( p = 0.0005 ) , and T ( 7 ) ( T ( 12 ) - T ( 5 ) ) and / ( / - T ( 10 ) ) in Group 8 ( p = 0.0005 ) .
RESULTS	A strictly unilateral sensory block was observed in 27 Group 4 patients ( 90 % ) , 28 Group 6 patients ( 93 % ) and 23 Group 8 patients ( 77 % ) ( p = 0.28 ) .
RESULTS	Complete unilateral motor block was observed in 29 Group 4 patients ( 97 % ) , 28 Group 6 patients ( 93 % ) , and 28 Group 8 patients ( 93 % ) ( p = 0.80 ) .
RESULTS	No failed blocks were reported .
RESULTS	Complete regression of spinal anesthesia required 71 + / - 20 minutes in Group 4 ( range : 40 to 110 min ) , 82 + / - 25 minutes in Group 6 ( range : 30 to 160 min ) , and 97 + / - 37 minutes in Group 8 ( range : 50 to 120 min ) ( p = 0.003 ) .
CONCLUSIONS	Hyperbaric bupivacaine 4 mg injected slowly through pencil-point directional needles in patients who are maintained in the lateral decubitus position for 15 minutes provided a surgical block that was mostly restricted to the operative side and adequate to perform knee arthroscopy , with a faster recovery profile than when a 6 mg or 8 mg dose was used .

###10375241
OBJECTIVE	In order to understand and update the prevalence of myopia in Taiwan , a nationwide survey was performed in 1995 .
METHODS	We stratified the cluster sampling by developmental grading of the city , using a size proportional to the population .
METHODS	Two cities were randomly selected from each city grading .
METHODS	The total number of students enrolled was 11,178 , including 5,676 boys and 5,502 girls .
METHODS	The refractive status and corneal radius of each student were measured with an autorefractometer under cycloplegia and checked with retinoscopy .
METHODS	Axial length was measured with biometric ultrasound .
RESULTS	The myopic rate was from 12 % at the age of 6 , it increased to 56 % at the age of 12 , and then to 76 % at the age of 15 .
RESULTS	A myopic rate of 84 % was found for the age range of 16 to 18 .
RESULTS	The prevalence of high myopia ( over -6.0 D ) at the age of 18 was 20 % in girls and 12 % in boys .
RESULTS	The mean refractive status became myopic at the age of 9 , then increased to -3.92 D in girls and -2.71 D in boys at the age of 18 .
RESULTS	The increase of axial length is correspondent with the progression of myopia .
RESULTS	The anterior chamber depth ( ACD ) was deeper with age and the severity of myopia , whereas the corneal curvature remained unchanged .
RESULTS	The lens thickness became thinner from age 7 to 13 , then it became thicker with age and the severity of myopia after age 15 .
RESULTS	The prevalence and degree of myopia in girls was more severe than in boys .
CONCLUSIONS	The prevalence of myopia in Taiwan increased year by year .
CONCLUSIONS	The increase in severity and prevalence of high myopia may be due to earlier onset .

###21062838
OBJECTIVE	The lack of effective school-based interventions for preventing obesity in children has caused a call for longer duration of interventions and better reporting on design and evaluation methodology .
OBJECTIVE	The purpose of this paper is to present the development of the intervention , the design of the effectiveness study , and the test-retest reliability of the main outcome measures in the HEalth In Adolescents ( HEIA ) study .
METHODS	The HEIA intervention programme was developed based on literature reviews , a social ecological framework , and focus groups .
METHODS	The intervention aimed to increase total physical activity ( PA ) and consumption of fruit and vegetables and to decrease screen time and consumption of sugar-sweetened beverages .
METHODS	The intervention programme consisted of a classroom component , including dietary behaviour lessons , computer tailoring , fruit/vegetable and PA breaks , and posters , and an environmental component including active transport campaigns , equipment , suggestions for easy improvements of schoolyards , inspirational courses for teachers ( all with regards to PA ) , and fact sheets to parents .
METHODS	The effect of the intervention programme is evaluated in a cluster randomised controlled trial design ( intervention = 12 schools , control = 25 schools ) including process evaluation .
METHODS	Main outcomes include anthropometry , PA , screen time , and consumption of fruit , vegetables , and sugar-sweetened beverages .
METHODS	A 2-week test - retest study was conducted among 114 pupils .
METHODS	Determinants of the behaviours were assessed .
METHODS	Similar data were collected from parents .
METHODS	Children 's PA was measured objectively by accelerometers .
CONCLUSIONS	The HEIA study represents a theoretically informed randomised trial comprising a comprehensive set of multilevel intervention components with a thorough evaluation using reliable outcome measures .
CONCLUSIONS	The study will contribute to a better understanding of determinants of healthy weight development among young people and how such determinants can be modified .

###22214253
BACKGROUND	A tea made from Eucommia ulmoides leaves and bark is part of the Japanese diet .
BACKGROUND	Eucommia is an herbal medicine that , by increasing nitric oxide , reduced blood pressure ( BP ) in rats and humans in an uncontrolled clinical trial .
OBJECTIVE	A controlled clinical trial was conducted to evaluate an aqueous bark extract of Eucommia standardized to eight percent pinoresinol di-beta-D-glucoside ( PG ) for BP reduction in humans .
METHODS	Study 1 : Twenty-four healthy adult subjects with a BP between 120-160/80 -100 mmHg were randomized to Eucommia extract 500 mg three times daily for eight weeks .
METHODS	Automatic 24-hour ambulatory blood pressure monitoring ( 24-h ABPM ) was utilized at baseline and after eight weeks .
METHODS	Study 2 : The effect of the Eucommia extract on isoproterenol-stimulated lipolysis was evaluated in a human fat cell assay to determine whether Eucommia was a beta-adrenergic blocker .
METHODS	Study 3 : Thirty healthy adult subjects with a BP between 120-160/80 -100 mmHg were randomized to 1 g Eucommia extract three times daily for two weeks with 24-h ABPM at baseline and after two weeks .
RESULTS	Study 1 : There was no toxicity or any difference in BP between the two groups .
RESULTS	Study 2 : Eucommia at 0.5 % w/v reduced isoproterenol-stimulated lipolysis from 2.67 to 1.4 times the buffer control ( P < 0.001 ) .
RESULTS	Study 3 : The Eucommia extract was well-tolerated and reduced BP by an average of 7.5 / 3.9 mmHg ( P < 0.008 ) .
CONCLUSIONS	The standardized Eucommia extract reduced BP and has beta-adrenergic blocking activity .
CONCLUSIONS	Eucommia may be an appropriate nutraceutical intervention for prehypertension .

###22263674
BACKGROUND	Statins are the standard-of-care therapy for reducing low-density lipoprotein cholesterol ( LDL-C ) levels ; however , combination with other lipid-modifying agents may be necessary to normalize lipid profiles in patients with mixed dyslipidemia who , in addition to high LDL-C , also have high triglycerides ( TG ) and low levels of high-density lipoprotein cholesterol ( HDL-C ) .
OBJECTIVE	This study aimed to evaluate the 1-year efficacy and safety of rosuvastatin in combination with fenofibric acid in a subgroup of patients treated for 12 weeks with rosuvastatin 10 mg + fenofibric acid 135 mg and subsequently treated for up to 52 weeks with rosuvastatin 20 mg + fenofibric acid 135 mg .
METHODS	The efficacy and safety of combination therapy with rosuvastatin + fenofibric acid were demonstrated in a 12-week controlled study ( NCT00300482 ) of patients with mixed dyslipidemia who were randomized to rosuvastatin 10 , 20 , or 40 mg , fenofibric acid 135 mg , or rosuvastatin 10 or 20 mg + fenofibric acid 135 mg .
METHODS	All patients who completed the controlled study were eligible to enroll in a subsequent 52-week open-label extension study ( NCT00300430 ) and received rosuvastatin 20 mg + fenofibric acid 135 mg .
METHODS	The present post hoc analysis evaluated patients who were treated with rosuvastatin 10 mg + fenofibric acid 135 mg in the controlled study and received rosuvastatin 20 mg + fenofibric acid 135 mg in the open-label extension study .
METHODS	The study was carried out at investigative sites in the US ( including Puerto Rico ) and Canada .
METHODS	Patients included in the study were men and women 18 years of age with mixed dyslipidemia , defined as TG 150 mg/dL , LDL-C 130 mg/dL , and HDL-C < 40/50 mg/dL for men/women ( at screening in the controlled trial ) .
METHODS	Efficacy variables included mean percentage changes in LDL-C , HDL-C , non-HDL-C , and apolipoprotein B ( ApoB ) , and median percentage changes in TG and high-sensitivity C-reactive protein ( hsCRP ) from baseline ( i.e. start of the open-label extension after 12 weeks of treatment with rosuvastatin 10 mg + fenofibric acid 135 mg ) to incremental time points up to 52 weeks in the extension study , and the proportion of patients achieving individual and combined goals for LDL-C and non-HDL-C .
METHODS	Adverse events ( AEs ) and clinical laboratory values were also assessed .
RESULTS	Of the 261 patients initially randomized to rosuvastatin 10 mg + fenofibric acid 135 mg , 220 completed the controlled study and 187 continued treatment with rosuvastatin 20 mg + fenofibric acid 135 mg in the extension study .
RESULTS	Increasing the rosuvastatin dose from 10 mg to 20 mg in combination with fenofibric acid 135 mg for up to 52 weeks resulted in significant ( p 0.005 for all comparisons ) mean percentage changes from baseline in LDL-C ( -9.5 % ) , non-HDL-C ( -6.0 % ) , ApoB ( -8.5 % ) , and HDL-C ( 3.6 % ) , while median TG levels remained largely unchanged ( 0.8 % , p = 0.055 ) at the week 52 visit .
RESULTS	Greater percentages of patients achieved their risk-stratified lipid goals at week 52 compared with baseline for LDL-C ( 89 % vs 84 % ) , non-HDL-C ( 50 % vs 25 % ) , and both LDL-C and non-HDL-C ( 50 % vs 19 % ) .
RESULTS	Combination therapy was generally well tolerated .
RESULTS	The incidence of muscle - , hepatic - , and renal-related AEs and laboratory values were within the expected range .
CONCLUSIONS	This study demonstrates that 1-year therapy with rosuvastatin + fenofibric acid is well tolerated and that increasing the rosuvastatin dose from 10 mg to 20 mg in the combination results in additional beneficial effects on key lipid parameters in patients with mixed dyslipidemia .
BACKGROUND	Clinicaltrials.gov identifiers NCT00300482 and NCT00300430 .

###25592006
OBJECTIVE	The aim of this study was to investigate the effects of ingesting caffeine and green coffee bean extract on blood glucose and insulin concentrations during a post-exercise oral glucose tolerance test .
METHODS	Ten male cyclists ( age : 26 5 y ; height : 179.9 5.4 cm ; weight : 77.6 13.3 kg ; body mass index : 24 4.3 kg/m ( 2 ) ; VO2 peak : 55.9 8.4 mLkgmin ( -1 ) ) participated in this study .
METHODS	In a randomized order , each participant completed three 30-min bouts of cycling at 60 % of peak power output .
METHODS	Immediately after exercise , each participant consumed 75 g of dextrose with either 5 mg/kg body weight of caffeine , 10 mg/kg of green coffee bean extract ( 5 mg/kg chlorogenic acid ) , or placebo .
METHODS	Venous blood samples were collected immediately before and after exercise during completion of the oral glucose tolerance test .
RESULTS	No significant time treatment effects for blood glucose and insulin were found .
RESULTS	Two-h glucose and insulin area under the curve values , respectively , for the caffeine ( 658 74 mmol/L and 30,005 13,304 pmol/L ) , green coffee bean extract ( 637 100 mmol/L and 31,965 23,586 pmol/L ) , and placebo ( 661 77 mmol/L and 27,020 12,339 pmol/L ) trials were not significantly different ( P > 0.05 ) .
CONCLUSIONS	Caffeine and green coffee bean extract did not significantly alter postexercise blood glucose and insulin concentrations when compared with a placebo .
CONCLUSIONS	More human research is needed to determine the impact of these combined nutritional treatments and exercise on changes in blood glucose and insulin .

###11918762
BACKGROUND	Anemia and malnutrition are significant complications in peritoneal dialysis ( PD ) patients .
BACKGROUND	Previous studies in hemodialysis have shown that androgens are effective as therapy for anemia ; however , this has not been tested in a randomized prospective trial in PD patients .
BACKGROUND	Furthermore , the anabolic properties of androgens may exert additional benefits on the nutritional status in this population .
METHODS	Twenty-seven stable male patients over 50 years who were under maintenance continuous ambulatory peritoneal dialysis ( CAPD ) therapy were randomized to receive recombinant human erythropoietin ( rHuEPO ; N = 14 ) or nandrolone decanoate ( ND ; 200 mg/week IM ; N = 13 ) as therapy for anemia .
METHODS	The evolution of hematologic parameters and the impact on both nutritional anthropometric and biochemical variables were evaluated after six months of treatment .
RESULTS	Hemoglobin and hematocrit experienced similar increases in both groups : from 8.5 + / - 0.9 g/dL and 25.8 + / - 2.7 % to 11.7 + / - 0.6 g/dL and 34.7 + / - 1.6 % ( P < 0.001 ) in patients receiving rHuEPO , and from 8.9 + / - 0.8 and 27 + / - 2.2 % to 11.8 + / - 0.4 g/dL and 35.1 + / - 1.5 % ( P < 0.001 ) in subjects treated with ND .
RESULTS	At the end of the study , out of the diverse nutritional variables included in this investigation , only weight and body mass index significantly increased in the rHuEPO group .
RESULTS	Conversely , both anthropometric [ weight , body mass index , triceps skinfold , mid-arm circumference ( MAC ) and mid-arm muscle circumference ( MAMC ) ] and biochemical parameters ( serum total proteins , albumin , prealbumin and transferrin ) were significantly increased in patients treated with ND .
RESULTS	In this group , serum urea nitrogen , urea net excretion and protein equivalent of nitrogen appearance significantly decreased .
RESULTS	These facts , together with an increase in serum creatinine and no changes in dietary intake during the study , suggest a rise in muscle mass related to an anabolic effect of nandrolone decanoate .
RESULTS	Interestingly , serum levels of insulin-like growth factor type 1 ( IGF-1 ) increased in patients on the androgen group compared to subjects treated with rHuEPO .
RESULTS	Moreover , there was a positive and significant correlation between the rise in IGF-1 concentrations and the increase in hemoglobin , hematocrit , MAC and MAMC .
CONCLUSIONS	Androgens therapy improved the anemia in elderly male CAPD patients in a similar manner to that observed with rHuEPO .
CONCLUSIONS	Furthermore , compared with rHuEPO , androgen administration was associated with beneficial effects on nutritional status .
CONCLUSIONS	The mechanism of action of androgens on hematologic and nutritional parameters might be mediated , at least in part , by IGF-1 .

###16680099
OBJECTIVE	To determine agreement between slit-lamp indirect ophthalmoscopy and Stratus optical coherence tomography ( OCT ) when assessing cup-to-disc ratios ( CDRs ) .
METHODS	Twenty-five ocular hypertensive subjects and 56 patients with primary open-angle glaucoma were included .
METHODS	Estimation of vertical ( VCDR ) and horizontal ( HCDR ) cup-to-disc ratio with slit-lamp ophthalmoscopy was made by three glaucoma specialists along with OCT scanning of optic nerve head .
METHODS	Agreement between OCT and specialists was measured by intraclass correlation coefficients ( ICC ) , Bland and Altman 's scatterplots , and a regression coefficient of the average difference .
RESULTS	The mean VCDR and HCDR was significantly higher ( P < 0.001 ) with OCT than that estimated by the specialists , with the difference ranging from 0.08 to 0.11 , and from 0.13 to 0.18 , respectively , depending on the specialist .
RESULTS	Difference was higher ( P < 0.001 ) for cuppings below 0.3 , and looses significance for larger VCDR cuppings ( above 0.7 ) .
RESULTS	ICC for VCDR was 0.87 among specialists , and ranges from 0.82 to 0.75 when comparing OCT and specialists .
RESULTS	ICC for HCDR was 0.83 among specialists and 0.74 between OCT and specialists .
RESULTS	When data were plotted according to the Bland-Altman method , as the cupping increased , the agreement also increased .
CONCLUSIONS	There is very good agreement among the specialists when estimating CDRs by stereoscopic slit-lamp biomicroscopy .
CONCLUSIONS	OCT shows higher values than the specialists ; the greatest differences occurred when assessing small CDRs and the differences diminished as the cupping increased .
CONCLUSIONS	These two methods of measurement are not interchangeable , and the difference must be considered , especially in discs with smaller CDRs .

###9130895
OBJECTIVE	To analyze the role of serum LH and of E2 secretion on IVF-ET outcome in patients stimulated with FSH .
METHODS	Using data from three studies , we analyzed ovarian response to FSH and IVF-ET outcome from two standpoints : [ 1 ] serum LH and [ 2 ] serum E2 on the day of hCG administration divided by the number of retrieved oocytes .
METHODS	Twenty-six academic and private clinical centers .
METHODS	Three hundred twenty-three ovulatory patients eligible for IVF-ET .
METHODS	Patients were treated with a GnRH agonist and FSH and underwent IVF-ET .
METHODS	Follicular development , embryos , and pregnancy rate ( PR ) .
RESULTS	Serum LH levels did not correlate significantly with number of oocytes retrieved , E2-oocyte ratio , fertilization rate , or PR .
RESULTS	Five patient subpopulations were identified on the basis of E2-oocyte ratios : 0 to 70 ( A ) , 70 to 140 ( B ) , 140 to 210 ( C ) , 210 to 280 ( D ) , and > 280 ( E ) pg/mL per oocyte ( conversion factor to SI unit , 3.671 ) .
RESULTS	Pregnancy rates were significantly different , i.e. , 5.3 % , 31.3 % , 18.1 % , 23.9 % , and 20.4 % for groups A , B , C , D , and E , respectively .
RESULTS	Groups were not different in terms of baseline characteristics , number of follicles , fertilization rates , and number of embryos transferred .
CONCLUSIONS	Patients with very low levels of LH respond to FSH alone as well as those with higher LH .
CONCLUSIONS	The E2-oocyte ratio is a strong index of success rate .

###22224253
OBJECTIVE	To observe the influence of rhubarb on gastrointestinal motility and intestinal mucosal barrier in patients with severe burn .
METHODS	Thirty patients with severe burn admitted to our burn wards within 48 hours after burn injury from December 2009 to December 2010 were divided into therapeutic group ( T , treated with 10 g rhubarb by nasal feeding and 5 g L-glutamine by oral administration beginning from 6 hours after admission , three times per day , and also given enteral nutrition beginning from 24 hours after admission , n = 16 ) and control group ( C , received the same treatment as used in T group but without rhubarb , n = 14 ) according to the random number table .
METHODS	Gastrointestinal function indexes including restoration of bowel sound within 24 hours , abdominal distension , tolerance to enteral nutrition , and defecation were observed after treatment .
METHODS	The serum samples were harvested on post burn day ( PBD ) 3 , 7 , 14 for determination of the levels of gastrin ( GAS ) by radioimmunoassay , motilin ( MTL ) by enzyme-linked immunosorbent assay , diamine oxidase ( DAO ) by enzyme spectrophotometry , and endotoxin ( ET ) by kinetic turbidimetric assay with TAL .
METHODS	Data were processed with t test and chi-square test .
RESULTS	Compared with those in C group , the numbers of patients with restoration of bowel sound within 24 hours and tolerance to enteral nutrition in T group were increased ( with chi2 value respectively 5.01 , 4.84 , P values all below 0.05 ) , the number of patients with abdominal distension was decreased ( chi2 = 4.84 , P = 0.025 ) .
RESULTS	Compared with those of C group , defecation time was earlier , number of bowel movement was increased with soft feces in patients of T group .
RESULTS	The serum levels of GAS in T group on PBD 3 , 7 , 14 [ ( 92 + / - 26 ) , ( 95 + / - 16 ) , ( 98 + / - 18 ) ng/L ] were significantly higher than those in C group [ ( 80 + / - 15 ) , ( 75 + / - 17 ) , ( 79 + / - 13 ) ng/L , with t value respectively 15.352 , 22.951 , 19.263 , P values all below 0.01 ] .
RESULTS	The serum levels of MTL in T group on PBD 3 , 7 , 14 [ ( 246 + / - 80 ) , ( 299 + / - 76 ) , ( 300 + / - 100 ) ng/L ] were significantly higher than those in C group [ ( 189 + / - 44 ) , ( 203 + / - 64 ) , ( 200 + / - 67 ) ng/L , with t value respectively 14.173 , 19.294 , 26.298 , P values all below 0.01 ] .
RESULTS	The serum levels of ET in T group on PBD 3 , 7 , 14 [ ( 0.398 + / - 0.035 ) , ( 0.373 + / - 0.005 ) , ( 0.238 + / - 0.019 ) EU/mL ] were significantly lower than those in C group [ ( 0.493 + / - 0.043 ) , ( 0.501 + / - 0.045 ) , ( 0.423 + / - 0.099 ) EU/mL , with t value respectively 6.213 , 9.153 , 15.134 , P < 0.05 or P < 0.01 ] .
RESULTS	The serum levels of DAO in T group on PBD 3 , 7 [ ( 3.0 + / - 0.4 ) , ( 2.9 + / - 0.5 ) U/mL ] were significantly lower than those in C group [ ( 3.9 + / - 0.5 ) , ( 3.6 + / - 0.6 ) U/mL , with t value respectively 3.982 , 4.236 , P values all below 0.05 ] , and there was no obvious difference between T and C groups on PBD 14 ( t = 1.762 , P > 0.05 ) .
CONCLUSIONS	Rhubarb can protect intestinal mucosal barrier in patients with severe burn through increasing secretion of gastrointestinal hormones and promoting restoration of gastrointestinal motility .

###25363178
BACKGROUND	Renal stones are common disorders that affect approximately 5 % to 10 % of the population and the incidence of renal stones is rising .
BACKGROUND	Treatment of ureteral stones is an important part of urologists and minimally invasive procedures such as ESWL and ureteroscopy effectiveness has been proven in various studies .
BACKGROUND	However , these methods are not completely safe and are expensive and can be complicated .
BACKGROUND	Purpose of this study is to evaluate the effectiveness of tamsulosin in the medical treatment of distal ureteral stones .
METHODS	A total of 96 patients with distal ureteral stones or UVj are randomly divided into two study group ( 50 patients ) and control group ( 46 patients ) .
METHODS	Patients in the control group allowed to freely consuming fluids ( hydration ) and indomethacin 100 mg PRN .
METHODS	Study group in addition to indomethacin and daily analgesic 0.4 mg tamsulosin was administered .
METHODS	All subjects in terms of analgesic dose , duration of expulsion and expulsion were studied .
RESULTS	Spontaneous expulsion of stone was occurred in 62.5 % ( 30 patients out of 46 ) of control group patients and 82 % ( 41 patients out of 50 ) that there was no significant difference ( P > 0.05 ) .
RESULTS	Average time to fix the stone in control group 4.7 8.03 days ( range 2 to 28 days ) and in the study group , 3.7 5.70 days ( range 1 to 23 days ) is significantly different ( P > 0.05 ) .
RESULTS	The average amount of analgesic consumption in the control group was 2.3 4.31 and in the study group was 1.48 2.15 that showed significant differences ( P < 0.05 ) .
CONCLUSIONS	In this study , although the addition of tamsulosin to conservative treatment of distal ureteral stones in the distal ureteral stone expulsion showed no significant difference between the two groups , but the reduction in the duration of expulsion , reduce pain and reduce the need for analgesic has been beneficial .

###12895267
OBJECTIVE	Initial high-dose interferon-alpha induction therapy in combination with ribavirin improves sustained response rates in treatment-nave patients .
OBJECTIVE	This prospective , randomized , controlled study tested whether non-responders or relapsers to interferon monotherapy also benefit from induction therapy .
METHODS	Patients with chronic hepatitis C who had not responded to ( n = 75 ) or relapsed ( n = 80 ) after previous interferon therapy were randomized to receive three different interferon doses during the first 14 weeks of therapy ( A : 10 MU IntronA/day for 2 weeks , followed by 10 MU/2 days for 12 weeks ; B :5 MU/d for 14 weeks ; C : 5 MU/2 days for 14 weeks ) followed in all by 5 MU/2 days for 24 weeks .
METHODS	All patients received 1-1 .2 g ribavirin/day throughout the whole study .
RESULTS	The rates of viral clearance at any time on treatment were similar in all groups .
RESULTS	Sustained response rates were also not different among the groups in interferon nonresponders ( A 32 % , B 29 % , C 31 % ) and relapsers ( A 64 % , B 68 % , C 71 % ) , respectively , as well as in patients with different genotypes .
RESULTS	As expected , sustained response rates were higher in patients with genotype non-1 than in those with genotype 1 .
CONCLUSIONS	High-dose induction therapy does not improve the outcome of interferon/ribavirin therapy in interferon nonresponders or relapsers .

###12460132
OBJECTIVE	To evaluate the agreement between adolescent self-reported cannabis use , `` on-site '' qualitative urine screening , and quantitative laboratory testing .
METHODS	A cross-sectional study of intake and follow-up data from 248 adolescents entering substance abuse treatment for cannabis use disorders ( abuse or dependence ) .
METHODS	This is part of the multi-site cooperative agreement Cannabis Youth Treatment study .
METHODS	Data collected from adolescents randomly assigned to one of five outpatient treatments at four sites : Operation PAR , Inc. , Florida ; Chestnut Health Systems , Illinois ; University of Connecticut Health Center , Connecticut ; and Children 's Hospital of Philadelphia , Pennsylvania .
METHODS	The data represent 248 unique individuals from a sample of 297 adolescents ranging in age from 12 to 18 years .
METHODS	Prevalence , agreement , kappa , sensitivity , specificity , positive and negative predictive value .
RESULTS	The self-report rates were higher at intake than either urine test ( 82.4 % vs. 77.0 % vs. 52.7 % ) , but both lower and higher at the 3-month follow-up ( 55.5 % vs. 70.0 % vs. 47.3 % ) and 6-month follow-up ( 60.2 % vs. 73.5 % vs. 55.8 % ) .
RESULTS	The disagreements went in both directions and the kappa coefficients were only in the moderate range ( 0.4 ) .
RESULTS	Over two-thirds of these frequent cannabis users tested positive when they said they had not used in 1 week and one-third tested positive even though they said it had been more than 4 weeks since last use .
CONCLUSIONS	The findings suggest both the advantages of multiple sources of information and the need for further work on the latency of cannabis metabolites in clinical populations .

###11956263
OBJECTIVE	Nasopharyngeal carcinoma ( NPC ) is highly sensitive to both radiotherapy ( RT ) and chemotherapy .
OBJECTIVE	This randomized phase III trial compared concurrent cisplatin-RT ( CRT ) with RT alone in patients with locoregionally advanced NPC .
METHODS	Patients with Ho 's N2 or N3 stage or N1 stage with nodal size > or = 4 cm were randomized to receive cisplatin 40 mg/m ( 2 ) weekly up to 8 weeks concurrently with radical RT ( CRT ) or RT alone .
METHODS	The primary end point was progression-free survival ( PFS ) .
RESULTS	Three hundred fifty eligible patients were randomized .
RESULTS	Baseline patient characteristics were comparable in both arms .
RESULTS	There were significantly more toxicities , including mucositis , myelosuppression , and weight loss in the CRT arm .
RESULTS	There were no treatment-related deaths in the CRT arm , and one patient died during treatment in the RT-alone arm .
RESULTS	At a median follow-up of 2.71 years , the 2-year PFS was 76 % in the CRT arm and 69 % in the RT-alone arm ( P = .10 ) with a hazards ratio of 1.367 ( 95 % confidence interval [ CI ] , 0.93 to 2.00 ) .
RESULTS	The treatment effect had a significant covariate interaction with tumor stage , and a subgroup analysis demonstrated a highly significant difference in favor of the CRT arm in Ho 's stage T3 ( P = .0075 ) with a hazards ratio of 2.328 ( 95 % CI , 1.26 to 4.28 ) .
RESULTS	For T3 stage , the time to first distant failure was statistically significantly different in favor of the CRT arm ( P = .016 ) .
CONCLUSIONS	Concurrent CRT is well tolerated in patients with advanced NPC in endemic areas .
CONCLUSIONS	Although PFS was not significantly different between the concurrent CRT arm and the RT-alone arm in the overall comparison , PFS was significantly prolonged in patients with advanced tumor and node stages .

###16108295
OBJECTIVE	The purpose of this study was to examine a church-based intervention employing a 6-month pilot weight loss program as a strategy to improve health of African-American adults .
METHODS	A randomized trial design was used without a control group .
METHODS	Eligible church members were randomized into two groups : an intervention delivered in the group setting and an intervention delivered in the individual setting .
METHODS	The study was conducted at an African-American church in Baton Rouge , Louisiana .
METHODS	Forty church members were enrolled in the study .
METHODS	Two trained church members without specialization in obesity treatment conducted the study .
METHODS	The primary outcome measure was weight loss .
RESULTS	The program retention rate was 90 % .
RESULTS	After six months , a modest but significant mean weight loss was seen in all participants of 3.3 kg .
RESULTS	The mean weight losses in the individual and group interventions were 3.4 kg and 3.1 kg , respectively .
RESULTS	The mean body fat loss was 2.1 kg and 1.9 kg , respectively .
RESULTS	The difference in weight loss and fat loss between the individual and group interventions was not statistically significant .
RESULTS	An improvement in the quality of life and an increase in physical activity were reported by the program participants .
CONCLUSIONS	A church setting may provide an effective delivery mechanism for a health and nutrition program .
CONCLUSIONS	Church members may be trained to conduct a weight control program .
CONCLUSIONS	Both interventions ( individual and group ) were effective in inducing weight loss .

###23361456
OBJECTIVE	To compare the hormonal-metabolic profiles and reproductive outcomes between women receiving metformin plus letrozole and women undergoing bilateral ovarian drilling in clomiphene citrate ( CC ) - resistant women with polycystic ovary syndrome ( PCOS ) .
METHODS	In this randomized study , 146 patients were randomly allocated into group 1 ( n = 73 ) who received metformin plus letrozole , and group 2 ( n = 73 ) who underwent bilateral ovarian drilling .
METHODS	Comparison was done between the basal and after treatment biochemical values for each group , in addition reproductive outcomes after treatment were compared between both groups .
RESULTS	There was significant reduction in testosterone ( p 0.001 ) , fasting insulin ( p 0.001 ) , and fasting glucose/fasting insulin ratio ( p = 0.029 ) in metformin plus letrozole group , while there was significant reduction in FSH , LH and LH/FSH ratio in bilateral drilling group ( p 0.001 , 0.001 and 0.001 ) .
RESULTS	No significant difference in cycle regularity ( p = 0.82 ) , ovulation ( p = 0.24 ) , pregnancy rate ( p = 0.32 ) and abortion rate ( p = 0.51 ) between both groups .
CONCLUSIONS	Both metformin plus letrozole and bilateral ovarian drilling are similarly effective as second-line strategies for the treatment of women with PCOS who do not conceive with CC .

###24229558
BACKGROUND	Educating emergency medical staffs in triage skills is an important aspect of disaster preparedness .
BACKGROUND	The aim of the study was to compare the effect of role-playing and educational video presentation on the learning and performance of the emergency medical service staffs in Khozestan , Iran
METHODS	A total of 144 emergency technicians were randomly classified into two groups .
METHODS	A researcher trained the first group using an educational video method and the second group with a role-playing method .
METHODS	Data were collected before , immediately , and 15 days after training using a questionnaire covering the three domains of demographic information , triage knowledge , and triage performance .
METHODS	The data were analyzed using defined knowledge and performance parameters .
RESULTS	There was no significant difference between the two training methods on performance and immediate knowledge ( P = .2 ) , lasting knowledge ( P = .05 ) and immediate performance ( P = .35 ) , but there was a statistical advantage for the role-playing method on lasting performance ( P = .02 ) .
CONCLUSIONS	The two educational methods equally increase knowledge and performance , but the role-playing method may have a more desirable and lasting effect on performance .

###11339515
OBJECTIVE	This double-blind , double-dummy , two-way comparative trial evaluated the overall efficacy and tolerability of intramuscular ( im ) vs oral meloxicam .
METHODS	346 patients with rheumatoid arthritis ( RA ) .
METHODS	173 patients in each group were randomised to receive either im meloxicam ( 15 mg ) plus a placebo tablet , or oral meloxicam ( 15 mg ) plus a placebo injection for 7 days .
RESULTS	Significant ( p < 0.001 ) improvements in overall pain and disease activity were observed by patients treated with im and oral meloxicam , with no significant difference between treatments .
RESULTS	The im formulation was better than the oral tablet in terms of rapidity of action ( p = 0.012 ) , global efficacy ( p = 0.030 ) and duration of morning stiffness ( p = 0.026 ) .
RESULTS	Local tolerability of im meloxicam was very good and comparable with placebo injections .
CONCLUSIONS	Oral and im meloxicam ( 15 mg ) were both effective and well-tolerated for acute exacerbations of RA .
CONCLUSIONS	The im formulation had some advantages , such as a faster onset of action .

###25057116
BACKGROUND	Although previous studies have illustrated improvements in surgical cohorts for patients with intervertebral disc herniation , there are limited data on predictors of long-term outcomes comparing surgical and nonsurgical outcomes .
OBJECTIVE	We assessed outcomes of operative and nonoperative treatment for patients with intervertebral disc herniation and symptomatic radiculopathy at 8years from the Spine Patient Outcomes Research Trial .
OBJECTIVE	We specifically examined subgroups to determine whether certain populations had a better long-term outcome with surgery or nonoperative treatment .
METHODS	Patients with symptomatic lumbar radiculopathy for at least 6weeks associated with nerve root irritation or neurologic deficit on examination and a confirmed disc herniation on cross-sectional imaging were enrolled at 13 different clinical sites .
METHODS	Patients consenting to participate in the randomized cohort were assigned to surgical or nonoperative treatment using variable permuted block randomization stratified by site .
METHODS	Those who declined randomization entered the observational cohort group based on treatment preference but were otherwise treated and followed identically to the randomized cohort .
METHODS	Of those in the randomized cohort , 309 of 501 ( 62 % ) provided 8-year data and in the observational group 469 of 743 ( 63 % ) .
METHODS	Patients were treated with either surgical discectomy or usual nonoperative care .
METHODS	By 8years , only 148 of 245 ( 60 % ) of those randomized to surgery had undergone surgery , whereas 122 of 256 ( 48 % ) of those randomized to nonoperative treatment had undergone surgery .
METHODS	The primary outcome measures were SF-36 bodily pain , SF-36 physical function , and Oswestry Disability Index collected at 6weeks , 3months , 6months , 12months , and then annually .
METHODS	Further analysis studied the following factors to determine if any were predictive of long-term outcomes : sex , herniation location , depression , smoking , work status , other joint problems , herniation level , herniation type , and duration of symptoms .
RESULTS	The intent-to-treat analysis of the randomized cohort at 8years showed no difference between surgical and nonoperative treatment for the primary outcome measures .
RESULTS	Secondary outcome measures of sciatica bothersomeness , leg pain , satisfaction with symptoms , and self-rated improvement showed greater improvement in the group randomized to surgery despite high levels of crossover .
RESULTS	The as-treated analysis of the combined randomized and observational cohorts , adjusted for potential confounders , showed advantages for surgery for all primary outcome measures ; however , this has the potential for confounding from other unrecognized variables .
RESULTS	Smokers and patients with depression or comorbid joint problems had worse functional outcomes overall ( with surgery and nonoperative care ) but similar surgical treatment effects .
RESULTS	Patients with sequestered fragments , symptom duration greater than 6months , those with higher levels of low back pain , or who were neither working nor disabled at baseline showed greater surgical treatment effects .
CONCLUSIONS	The intent-to-treat analysis , which is complicated by high rates of crossover , showed no difference over 8years for primary outcomes of overall pain , physical function , and back-related disability but did show small advantages for secondary outcomes of sciatica bothersomeness , satisfaction with symptoms , and self-rated improvement .
CONCLUSIONS	Subgroup analyses identified those groups with sequestered fragments on MRI , higher levels of baseline back pain accompanying radiculopathy , a longer duration of symptoms , and those who were neither working nor disabled at baseline with a greater relative advantage from surgery at 8years .
METHODS	Level II , therapeutic study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###23213004
OBJECTIVE	To evaluate the metrologic properties of composite disease activity indices in rheumatoid arthritis ( RA ) , utilizing information derived from clinical , gray-scale ( GS ) , and power Doppler ( PD ) ultrasound examinations , and to assess the classification of patients according to disease activity using such indices .
METHODS	This ancillary study utilized data from a multicenter , prospective , randomized , parallel-group study conducted in subjects with moderate RA randomized to receive etanercept and methotrexate ( ETN + MTX ) or usual care ( various disease-modifying antirheumatic drugs [ DMARDs ] ) .
METHODS	In multimodal indices , the 28 swollen joint count was either supplemented or replaced by clinically nonswollen joints in which the presence of synovitis was detected either by GS and/or PD and was calculated according to the Disease Activity Score in 28 joints ( DAS28 ) or the Simplified Disease Activity Index ( SDAI ) .
METHODS	Reliability , external validity , and discriminative capacity were calculated at baseline/screening by intraclass correlation coefficient , Pearson 's correlation , and standardized response mean , respectively .
RESULTS	Data from 62 patients ( mean SD age 53.8 13.2 years , mean SD disease duration 8.8 7.7 years , mean SD disease activity 4.6 0.5 [ DAS28 ] and 20.9 5.9 [ SDAI ] ) were analyzed , with 32 receiving ETN + MTX and 30 receiving DMARDs .
RESULTS	The metrologic properties were at least as good for GS - and/or PD-based indices as for their clinical counterparts .
RESULTS	Using GS - and PD-supplemented indices , an additional 67.8 % and 32.3 % of patients ( DAS28-derived and SDAI-derived indices , respectively ) could be classified as having high disease activity at the screening visit .
CONCLUSIONS	Multimodal indices incorporating ultrasound and clinical data had similar metrologic properties to their clinical counterparts ; certain indices allowed for a significantly larger number of patients to be classified to either high or moderate disease activity at the screening visit .

###7644960
METHODS	A randomized , placebo-controlled trial in which patients received either usual care by a general practitioner ( information and analgesics ) , or placebo physiotherapy given by a physiotherapist , or exercise therapy given by a physiotherapist .
OBJECTIVE	To assess the efficacy of exercise therapy on sickness absence from work in patients with acute low back pain .
BACKGROUND	Exercise therapy during the nonchronic phase of back pain is considered to reduce sickness absence , but this opinion is controversial .
METHODS	Patients with acute nonspecific low back pain and a paid job were included for analysis .
METHODS	Sickness absence ( number of days ) was checked monthly during the 1-year follow-up period and compliance was also assessed .
RESULTS	From 40 general practices 363 patients who were gainfully employed were included .
RESULTS	In the exercise therapy group the percentage of patients with sickness absence was higher and the duration of absence was longer than in the placebo and usual care groups , but these differences were not significant .
RESULTS	Indications of more absence in the exercise therapy group appeared to be based largely on a greater number of patients with absences during the first 3 months .
RESULTS	Patients in the exercise group who had not reported sick at entry had more sickness absences during the follow-up year than patients in the usual care and placebo group .
RESULTS	Good compliance did not affect the results .
CONCLUSIONS	Exercise therapy for patients with acute low back pain does not reduce sickness absence .

###19939369
OBJECTIVE	To evaluate the impact of follicle-stimulating hormone ( FSH ) with different glycosylation patterns on oocyte quality and clinical outcomes in an in vitro fertilization ( IVF ) treatment program .
METHODS	Prospective randomized , open-label , clinical study .
METHODS	Assisted reproduction center .
METHODS	One hundred eighty-eight infertile couples undergoing assisted fertilization treatment .
METHODS	All participants underwent a standard down-regulation with a gonadotropin-releasing hormone ( GnRH ) analogue .
METHODS	The patients were randomized into three groups : 63 patients received combined sequential acidic and less-acidic FSH , 65 patients received only less-acidic FSH ( recombinant FSH ) , and 60 received only acidic FSH ( human-derived FSH ) .
METHODS	Number of mature metaphase II oocytes , embryo quality , clinical pregnancy rates , and implantation rates .
RESULTS	The pregnancy and implantation rates were statistically significantly lower in the less-acidic recombinant FSH alone group than in the combined sequential acidic hFSH/less-acidic recombinant FSH , and acidic hFSH alone groups ( 33.3 % , 43.5 % , 39 % and 17.3 % , 24.5 % , 20.4 % , respectively ) .
RESULTS	Metaphase II oocytes and grade 1 embryos were statistically significantly higher in favor of the combined sequential acidic hFSH/less-acidic recombinant FSH group compared with the less-acidic recombinant FSH alone group .
CONCLUSIONS	The glycosylation patterns of the two types of FSH implemented for ovarian stimulation have different impacts on oocyte quality and clinical outcome .
CONCLUSIONS	A sequential combined protocol using both acidic and less-acidic FSH for ovarian stimulation improves oocyte maturity and embryo cleavage , and increases pregnancy and implantation rates .

###17674759
OBJECTIVE	To study the influence caused by the different intervention opportunity and frequencies in treatment chronic sinusitis after endoscopic sinus surgery .
METHODS	Eighty patients with chronic sinusitis and nasal polyps were divided into group A and group B randomly .
METHODS	First postoperative management of functional endoscopic sinus surgery was taken in one week after operation , a week one time at first and second month , two weeks one time at third and fourth month , one month one time after fifth month , in group A. First postoperative management of functional endoscopic sinus surgery was taken in two weeks after operation , two weeks one time at first and second month , one month one time from third month to fifth month , two month one time after sixth month , in group B.
METHODS	The nasal middle meatus mucociliary transport rate ( MTR ) was measured by saccharin method at third month , sixth month and twelfth month , the rate of epithelialization was measured at third months and the efficiency rate was measured at twelfth months after operation .
RESULTS	All results were no significant difference .
CONCLUSIONS	Appropriate extended postoperative management time and decrease intervention frequencies were not influence the therapeutic effect of endoscopic surgery for chronic sinusitis and/or nasal polyps .

###24138536
BACKGROUND	Dyslipidemia due to diabetes is characterized by hypertriglyceridemia and reduced levels of high-density lipoprotein cholesterol ( HDL-C ) and elevated or normal levels of low-density lipoprotein cholesterol ( LDL-C ) in type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	The objectives of this Phase III study were to evaluate the safety , tolerability , and efficacy of saroglitazar ( ZYH1 ) 2-mg and 4-mg tablets ( Lipaglyn ; Zydus Cadila , Ahmedabad , India ) compared with placebo in patients with diabetic dyslipidemia who are not controlled with atorvastatin 10mg therapy .
METHODS	This was a 16-week prospective , multicenter , randomized , double-blind , placebo controlled , three-arm Phase III study in subjects with hypertriglyceridemia ( > 200 and < 500mg/dL ) with T2DM not controlled with atorvastatin 10mg .
METHODS	The study consisted of a run-in period of 4 weeks of life-style modification followed by 12 weeks of treatment with saroglitazar ( 2-mg or 4-mg ) or placebo tablets .
METHODS	The primary end point was the change in plasma triglyceride level compared with baseline and the placebo arm at the end of Week 12 .
METHODS	The secondary exploratory end points were change in lipid profile and fasting plasma glucose at Week 12 .
METHODS	In total , 302 subjects were randomized to receive one of the treatments , saroglitazar 2mg ( n = 101 ) or saroglitazar 4mg ( n = 99 ) , or matching placebo ( n = 102 ) .
METHODS	Patients who received study medication and had undergone at least one post baseline efficacy evaluation were included in the efficacy analysis .
RESULTS	At Week 12 , saroglitazar 2-mg and 4-mg tablets significantly reduced mean plasma triglyceride levels by -45.53.03 % and -46.73.02 % ( meanSE ) , respectively , and the difference was significant ( P < 0.001 ) compared with placebo .
RESULTS	Saroglitazar 2mg demonstrated significant decrease in levels of non-HDL-C , very LDL-C , total cholesterol , and fasting plasma glucose .
RESULTS	Additionally , saroglitazar 4mg also significantly reduced LDL-C and apolipoprotein B levels .
RESULTS	Saroglitazar was found to be safe and well tolerated by patients .
CONCLUSIONS	Saroglitazar appeared to be an effective and safe therapeutic option for improving hypertriglyceridemia in patients with T2DM .

###9391254
BACKGROUND	Few studies have compared vasoactive drugs with endoscopic sclerotherapy in the control of acute variceal haemorrhage .
BACKGROUND	Octreotide is widely used for this purpose , but its value remains undetermined .
OBJECTIVE	To compare octreotide with endoscopic sclerotherapy for acute variceal haemorrhage .
METHODS	Consecutive patients with acute variceal haemorrhage .
METHODS	Patients were randomised at endoscopy to receive either a 48 hour intravenous infusion of 50 pg/h octreotide ( n = 73 ) , or emergency sclerotherapy ( n = 77 ) .
RESULTS	Overall control of bleeding and mortality was not significantly different between octreotide ( 85 % , 62 patients ) and sclerotherapy ( 82 % , 63 patients ) over the 48 hour trial period ( relative risk of rebleeding 0.83 ; 95 % confidence interval ( CI ) 0.38 to 1.82 ) , irrespective of Child 's grading or active bleeding at endoscopy .
RESULTS	One major complication was observed in the sclerotherapy group ( aspiration ) and two in the octreotide group ( pulmonary oedema , severe paralytic ileus ) .
RESULTS	During 60 days of follow up there was an overall trend towards an increased mortality in the octreotide group which was not statistically significant ( relative risk of dying at 60 days 1.91 , 95 % CI 0.97 to 3.78 , p = 0.06 ) .
CONCLUSIONS	The results of this study indicate that intravenous octreotide is as effective as injection sclerotherapy in the control of acute variceal bleeding , but further controlled trials are necessary to evaluate the safety of this treatment .

###19322104
BACKGROUND	There is some evidence that sleep patterns may be affected by iron deficiency anemia but the role of iron in sleep has not been tested in a randomized iron supplementation trial .
OBJECTIVE	We investigated the effect of iron supplementation on maternal reports of sleep in infants in 2 randomized , placebo-controlled trials from Pemba Island , Zanzibar , and Nepal .
METHODS	In both studies , which had parallel designs and were carried out in years 2002 to 2003 , infants received iron-folic acid with or without zinc daily for 12 months , and assessments of development were made every 3 months for the duration of the study .
METHODS	Eight hundred seventy-seven Pemban ( 12.5 + / - 4.0 months old ) and 567 Nepali ( 10.8 + / - 4.0 months ) infants participated .
METHODS	Maternal reports of sleep patterns ( napping frequency and duration , nighttime sleep duration , frequency of night waking ) were collected .
RESULTS	Mean Hb concentration was 9.2 + / - 1.1 for Pemban and 10.1 + / - 1.2 g/dL for Nepali infants .
RESULTS	Approximately , one-third of the children were stunted .
RESULTS	Supplemental iron was consistently associated with longer night and total sleep duration .
RESULTS	The effects of zinc supplementation also included longer sleep duration .
CONCLUSIONS	Micronutrient supplementation in infants at high risk for iron deficiency and iron deficiency anemia was related to increased night sleep duration and less night waking .

###8836263
BACKGROUND	The neuroendocrine response following major surgery has not been previously influenced by either regional anaesthetic techniques or opioid analgesia probably due to insufficient intraoperative afferent neural blockade .
BACKGROUND	In this study we attempted to determine whether significant inhibition of these pathways could be achieved by combining preoperative high spinal anaesthesia with postoperative thoracic epidural anaesthesia .
BACKGROUND	In theory too , there may be additional benefits over perioperative thoracic epidural anaesthesia on pain and pulmonary dysfunction .
METHODS	20 ASA 1-3 patients undergoing elective colonic surgery were studied .
METHODS	Gp 1 ( n = 10 ) received a high spinal intraoperative block to T4 using 6mls of 0.5 % bupivacaine plus continuous epidural 0.125 % bupivacaine/0 .0025 % diamorphine .
METHODS	Gp 2 ( n = 10 ) patients received epidural 0.5 % bupivacaine block to T4 plus continuous epidural infusion of 0.125 % bupivacaine/0 .0025 % diamorphine .
METHODS	We measured a ) plasma glucose and cortisol at 0 , 1 , 2 , 3 , 4 , 8 and 24 h ; b ) forced vital capacity ( FVC ) , forced expiratory volume in the first second ( FEV1 ) and peak flow rate ( PFR ) preoperatively , at 8 and 24 h ; c ) visual analogue pain scores ( VAS 0-10 ) at rest , cough and mobilisation at 8 and 24 h ; d ) block height every hour for 12 hours then 3 hourly ; e ) 24-hour urine volumes for dopamine , adrenaline and noradrenaline f ) 24-hour PCA morphine requirements .
RESULTS	The two groups did not differ in age , sex , height , weight , duration of surgery , blood loss or serum albumin .
RESULTS	Pain relief was excellent and similar in both groups .
RESULTS	The average 24 hour morphine consumption was 10 mg in both groups with no differences in the block height .
RESULTS	All the patients had a 30-50 % reduction in FEV1 , FVC and PFR ( P > 0.05 ) .
RESULTS	Metabolically , there was no statistical difference between the 2 groups except a higher rise in glucose in Gp1 at 2 and 3 h ( P = 0.0312 and 0.014 ) .
RESULTS	24-hour catecholamine studies showed no differences for noradrenaline ( P = 0.8 ) , adrenaline ( P = 0.47 ) and dopamine ( P = 0.36 ) .
CONCLUSIONS	Thoracic epidural bupivacaine/diamorphine infusion provided excellent postoperative analgesia following colonic surgery .
CONCLUSIONS	An intraoperative combined spinal/epidural technique conferred no additional benefit on analgesia , pulmonary function and the neuroendocrine response .

###10350666
BACKGROUND	Multiple investigations both in experimental models and in middle-aged patients with essential hypertension have demonstrated impaired endothelium-dependent vasodilation .
OBJECTIVE	To determine whether hypertension exerts an additional negative effect on endothelial function of large arteries in hypertensive elderly patients who may already be affected by endothelial dysfunction due to aging .
METHODS	Thirteen elderly patients with hypertension ( 69 9 years of age [ mean SD ] ) were compared with 13 matched healthy elderly subjects ( 72 6 years of age ) .
METHODS	High resolution vascular ultrasound was used to measure brachial artery responses to reactive hyperemia ( with increased flow causing endothelium-dependent dilation ) and to sublingual nitroglycerine ( causing endothelium-independent dilation ) .
RESULTS	Flow-mediated diameter ( FMD ) was significantly impaired in the hypertensive elderly group ( 6.7 3.3 % versus 13.3 3.8 % in the control group , P < 0.05 ) .
RESULTS	No significant difference could be found in nitroglycerine-induced dilation between the elderly control group ( 12.1 4.9 % ) and the hypertensive elderly ( 10.2 6.8 % ) .
RESULTS	On simple linear analysis , FMD was inversely correlated with age ( r = -0.60 , P = 0.03 ) in the healthy elderly group .
RESULTS	FMD in the hypertensive elderly was inversely related to age ( r = -0.41 , P = 0.04 ) and mean blood pressure ( r = -0.67 , P = 0.01 ) .
CONCLUSIONS	This study showed decreased FMD with aging even in the healthy elderly , with a further decline in hypertensive elderly compared with healthy elderly subjects .
CONCLUSIONS	This impairment of FMD in the hypertensive elderly group was related to age and mean blood pressure , indicating that aging and hypertension may impair endothelial function in the brachial artery of elderly patients with hypertension .

###19131432
BACKGROUND	Apnoea of prematurity ( AOP ) is a common problem in preterm infants which can be treated with various modes of nasal continuous positive airway pressure ( NCPAP ) or nasal intermittent positive pressure ventilation ( NIPPV ) .
BACKGROUND	It is not known which mode of NCPAP or NIPPV is most effective for AOP .
OBJECTIVE	To assess the effect of four NCPAP/NIPPV systems on the rate of bradycardias and desaturation events in very low birthweight infants .
METHODS	Sixteen infants ( mean gestational age at time of study 31 weeks , 10 males ) with AOP were enrolled in a randomised controlled trial with a crossover design .
METHODS	The infants were allocated to receive nasal pressure support using four different modes for 6 h each : NIPPV via a conventional ventilator , NIPPV and NCPAP via a variable flow device , and NCPAP delivered via a constant flow underwater bubble system .
METHODS	The primary outcome was the cumulative event rate of bradycardias ( < or = 80 beats per minute ) and desaturation events ( < or = 80 % arterial oxygen saturation ) , which was obtained from cardio-respiratory recordings .
RESULTS	The median event rate was 6.7 per hour with the conventional ventilator in NIPPV mode , and 2.8 and 4.4 per hour with the variable flow device in NCPAP and NIPPV mode , respectively ( p value < 0.03 for both compared to NIPPV/conventional ventilator ) .
RESULTS	There was no significant difference between the NIPPV/conventional ventilator and the underwater bubble system .
CONCLUSIONS	A variable flow NCPAP device may be more effective in treating AOP in preterm infants than a conventional ventilator in NIPPV mode .
CONCLUSIONS	It remains unclear whether synchronised NIPPV would be even more effective .

###15166570
BACKGROUND	Intrathecal administration of opioids may cause lower urinary tract dysfunction .
BACKGROUND	In this study , the authors compared the effects of morphine and sufentanil administered intrathecally in a randomized double-blind fashion ( two doses each ) on lower urinary tract function in healthy male volunteers .
METHODS	Urodynamic evaluation was performed before and every hour after drug administration up to complete recovery of lower urinary tract function using pressure and flow measurements recorded from catheters in the bladder and rectum .
METHODS	Sense of urge and urinary flow rates were assessed every hour by filling the bladder with its cystometric capacity and asking the patient to void .
METHODS	Full recovery was defined as a residual volume of less than 10 % of bladder capacity and a maximum flow rate within 10 % of the initial value .
RESULTS	Intrathecal administration of both opioids caused dose-dependent suppression of detrusor contractility and decreased sensation of urge .
RESULTS	Mean times to recovery of normal lower urinary tract function were 5 and 8 h after 10 or 30 microg sufentanil and 14 and 20 h after 0.1 or 0.3 mg morphine , respectively .
RESULTS	This recovery profile can be explained by the spinal pharmacokinetics of both opioids .
CONCLUSIONS	Intrathecal opioids decrease bladder function by causing dose-dependent suppression of detrusor contractility and decreased sensation of urge .
CONCLUSIONS	Recovery of normal lower urinary tract function is significantly faster after intrathecal sufentanil than after morphine , and the recovery time is clearly dose dependent .

###14519610
BACKGROUND	The Outcomes of Depression International Network ( ODIN ) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care .
BACKGROUND	Only about half of the patients in the treatment arm complied with the offer of treatment , prompting the question : ` what was the effect of treatment in those patients who actually received it ? '
OBJECTIVE	To illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up .
METHODS	We estimated the complier average causal effect ( CACE ) of treatment .
RESULTS	In the ODIN trial the effect of receipt of psychological intervention ( an average of about 4 points on the Beck Depression Inventory ) is about twice that of offering it .
CONCLUSIONS	The statistical analysis of the results of a clinical trial subject to non-compliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report .

###16790200
OBJECTIVE	It has been clearly demonstrated that abciximab is useful in percutaneous coronary interventions .
OBJECTIVE	However , it is not known if intracoronary administration of the initial abciximab bolus improves outcome .
OBJECTIVE	Moreover , there may be safety concerns .
METHODS	The study was a single-center prospective randomized trial that included all patients undergoing coronary angioplasty involving the use of abciximab .
METHODS	Patients were randomized to either intracoronary or intravenous administration of the abciximab bolus .
METHODS	The primary endpoint was the incidence of major adverse cardiac events ( i.e. , death , myocardial infarction , or the need for revascularization ) ; secondary endpoints were hemorrhagic complications and the troponin-I level .
RESULTS	The study included 137 patients ; 72 received an intracoronary abciximab bolus and 65 , an intravenous bolus .
RESULTS	Clinical characteristics and baseline angiographic findings were similar in the two groups .
RESULTS	All patients underwent coronary stent implantation .
RESULTS	No difference was observed between the intracoronary bolus group and the intravenous bolus group in type of stent used ( drug eluting stent 47.2 % vs 50.8 % , respectively ) , total stent length , or final TIMI flow grade ( 3 vs 2.97 , respectively ) .
RESULTS	The intervention success rates were also similar ( 98.5 % vs. 99 % , respectively ) .
RESULTS	No complication associated with the administration route was reported .
RESULTS	However , the level of the myocardial injury marker troponin I increased significantly in the intravenous bolus group .
RESULTS	Clinical follow-up at 1 year did not reveal any difference in the incidence of major adverse cardiac events : 8.5 % in the intracoronary bolus group versus 6.2 % in the intravenous bolus group .
CONCLUSIONS	Intracoronary administration of an abciximab bolus did not appear to be less safe or effective than intravenous administration .
CONCLUSIONS	Less post-procedural myocardial damage was observed in the intracoronary bolus group .

###23111127
BACKGROUND	Many people in Western countries do not follow public health physical activity ( PA ) recommendations .
BACKGROUND	Web-based interventions provide cost - and time-efficient means of delivering individually targeted lifestyle modification at a population level .
OBJECTIVE	To examine whether access to a website with individually tailored feedback and suggestions on how to increase PA led to improved PA , anthropometrics , and health measurements .
METHODS	Physically inactive adults ( n = 12,287 ) participating in a nationwide eHealth survey and health examination in Denmark were randomly assigned to either an intervention ( website ) ( n = 6055 ) or a no-intervention control group ( n = 6232 ) in 2008 .
METHODS	The intervention website was founded on the theories of stages of change and of planned behavior and , apart from a forum page where a physiotherapist answered questions about PA and training , was fully automated .
METHODS	After 3 and again after 6 months we emailed participants invitations to answer a Web-based follow-up questionnaire , which included the long version of the International Physical Activity Questionnaire .
METHODS	A subgroup of participants ( n = 1190 ) were invited to a follow-up health examination at 3 months .
RESULTS	Less than 22.0 % ( 694/3156 ) of the participants logged on to the website once and only 7.0 % ( 222/3159 ) logged on frequently .
RESULTS	We found no difference in PA level between the website and control groups at 3 - and 6-month follow-ups .
RESULTS	By dividing participants into three groups according to use of the intervention website , we found a significant difference in total and leisure-time PA in the website group .
RESULTS	The follow-up health examination showed no significant reductions in body mass index , waist circumference , body fat percentage , and blood pressure , or improvements in arm strength and aerobic fitness in the website group .
CONCLUSIONS	Based on our findings , we suggest that active users of a Web-based PA intervention can improve their level of PA. .
CONCLUSIONS	However , for unmotivated users , single-tailored feedback may be too brief .
CONCLUSIONS	Future research should focus on developing more sophisticated interventions with the potential to reach both motivated and unmotivated sedentary individuals .
BACKGROUND	Clinicaltrials.gov NCT01295203 ; http://clinicaltrials.gov/ct2/show/NCT01295203 ( Archived by WebCite at http://www.webcitation.org/6B7HDMqiQ ) .

###24456217
BACKGROUND	The Japan Atherosclerosis Society 's 2007 Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases ( JAS2007GL ) advocate reducing LDL cholesterol ( LDL-C ) to target levels in patients with dyslipidemia , but achievement rates are frequently unsatisfactory even in the presence of lipid-lowering therapy .
BACKGROUND	This multicenter , open-label , randomized , parallel-group study compared the efficacy of rosuvastatin and atorvastatin on JAS2007GL LDL-C goals in Japanese patients not achieving their target goal with atorvastatin treatment .
METHODS	The study involved 20 clinical institutes in Japan ( Kishiwada Atherosclerosis Prevention Study [ KAPS ] Group ) .
METHODS	Patients with category II or III risk of coronary artery disease ( CAD ) , or those with a history of CAD ( secondary prevention ) , who had not achieved their JAS2007GL LDL-C goals during treatment with atorvastatin for at least 4 weeks were switched either to rosuvastatin 5 mg/day ( from atorvastatin 10 mg/day ) or rosuvastatin 10 mg/day ( from atorvastatin 20 mg/day ) ( n = 75 ) or continued to receive atorvastatin ( n = 77 ) .
METHODS	The primary endpoint was achievement of LDL-C goals at 3 months .
METHODS	The main secondary endpoint was achievement of LDL-C goal + high-sensitivity C-reactive protein level < 1.0 mg/L at 3 months .
RESULTS	Achievement rates for the primary endpoint were 49.3 % in the rosuvastatin group and 31.7 % in the atorvastatin group ( P = 0.022 ) .
RESULTS	Achievement rates for the main secondary endpoint were 40.0 % in the rosuvastatin group and 20.8 % in the atorvastatin group ( P = 0.010 ) .
RESULTS	Rosuvastatin and atorvastatin were both well tolerated in this study .
CONCLUSIONS	Rosuvastatin is a useful treatment option for Japanese patients who are not achieving their JAS2007GL LDL-C goal with atorvastatin .

###12219998
OBJECTIVE	To compare the intraocular pressure ( IOP ) response of uncontrolled capsular glaucoma ( CG ) and primary open-angle glaucoma ( POAG ) to selective laser trabeculoplasty ( SLT ) in a prospective clinical trial .
METHODS	Ten eyes often patients suffering from uncontrolled CG ( CG Group ) and ten eyes of ten patients with uncontrolled POAG ( POAG Group ) were treated with a frequency-doubled , Q-switched Nd : YAG laser ( 532 nm ) .
METHODS	The baseline characteristics were similar in both groups .
METHODS	IOP was measured before and 1 day , 1 week , 1 month and 3 , 6 , 9 , 12 , 15 and 18 months after treatment .
METHODS	Success was defined as IOP more than 20 % lower than before treatment .
METHODS	Any change of hypotensive medication led to the subjects ' exclusion from the study .
METHODS	The two groups were compared using the independent-sample t test for continuous variables and the log-rank test for survival analysis .
METHODS	A value of p < 0.05 was considered significant .
RESULTS	The mean follow-up was 12.0 months ( SD 5.5 ) for the CG group and 13.5 months ( SD 4.3 ) for POAG ( n.s. ) .
RESULTS	No significant difference was found between the two groups for mean pretreatment IOP ( 23.6 mmHg + / - 5.70 in the CG group and 22.8 mmHg + / - 2.44 in the POAG group ) or for mean IOP and mean IOP reductions during the follow-up .
RESULTS	At all follow-up visits , IOP was reduced less in the CG group than in the POAG group ( 24.8 % + / - 11.15 vs. 27.7 % + / - 9.91 at 6 months , 22.0 % + / - 6.66 vs. 30.6 % + / - 6.35 at 12 months , and 31.4 % + / - 5.55 vs. 35.1 % + / - 1.75 at 18 months ) , but the difference was significant only at 12 months .
RESULTS	Kaplan-Meier survival analysis gave an 18-month success rate of 64 % in the CG group and 78 % in the POAG group , with no significant differences between the groups .
CONCLUSIONS	SLTis an effective procedure forlowering IOP in CG and POAG eyes , although the effect seems to last less in CG eyes .

###23499523
BACKGROUND	We aimed to assess whether echocardiographically-optimised atrioventricular ( AV ) and interventricular ( VV ) delay programming provided any additional benefit over standard settings following biventricular pacemaker implantation in patients with advanced heart failure .
METHODS	Paired data were collected on 22 patients ( aged 67.5 8.3 years , 16 male ) with refractory heart failure , NYHA class III/IV symptoms , sinus rhythm , LBBB and a broad QRS complex > 120 ms. All patients underwent implantation of a biventricular pacemaker and were randomised to eight weeks of factory pacing mode ( Mode 1 ) or echocardiographically-guided pacing mode ( Mode 2 ) , followed by eight weeks in the alternate mode , in a randomised blinded crossover design .
RESULTS	Peak oxygen consumption , 6 min walk distance , NYHA class and quality of life scores improved after biventricular pacing , but no significant difference was found between the two modes , with the exception of peak oxygen consumption score ( baseline : 14.8 0.9 , Mode 1 : 14.6 1.2 , Mode 2 : 16.1 1.2 mL/kg/min ) , which was better in Mode 2 than Mode 1 ( p 0.003 ) .
CONCLUSIONS	Transthoracic echocardiographic optimisation of AV and VV delays following biventricular pacing may offer additional clinical benefit in an unselected group of patients when compared with factory settings .

###11490185
OBJECTIVE	To investigate whether not shaving hair in neurosurgical operations carries an increased infection rate .
METHODS	Taking advantage of different practices among neurosurgeons in a single institution , we embarked upon a prospective non-randomised study of 100 consecutive neurosurgical procedures involving 90 paediatric patients aged 7 days to 16.8 years .
METHODS	The patients were split into two groups ( ` hair shave ' and ` no hair shave ' ) .
METHODS	The differences with respect to wound complications , positive microbiology on wound culture swabs and wound infection rates were analysed .
METHODS	Other factors considered were the cleansing solution , prophylactic antibiotic regime , duration of the operation , the surgeon 's experience and the patient 's age .
RESULTS	The only complications observed were 4 incidences of wound dehiscence ( 2 in the hair shave and 2 in the no hair shave group ) and 3 shunt infections ( 2 in the hair shave and 1 in the no hair shave group ) .
RESULTS	We did not find any significant difference between the two arms for any of the factors assessed .
RESULTS	Age was a significant factor in shunt infection , as all shunt infections were seen in patients aged less than 6 months , regardless of whether the hair was shaved or not ( p = 0.024 , Fisher 's exact test ) .
CONCLUSIONS	This study confirms our clinical experience that no hair shave is a good alternative to the traditional hair shaving approach , allowing patients to enjoy the psychological benefits of undisturbed body image while recovering from major surgery .

###15145879
OBJECTIVE	To assess with magnetic resonance imaging ( MRI ) cardiovascular function in response to exercise in patients after atrial correction of transposition of the great arteries ( TGA ) .
METHODS	Cardiac function at rest and during submaximal exercise was assessed with MRI in 27 patients with TGA ( mean ( SD ) age 26 ( 5 ) years ) late ( 23 ( 2 ) years ) after atrial correction and in 14 control participants ( 25 ( 5 ) years old ) .
RESULTS	At rest , only right ventricular ejection fraction was significantly lower in patients than in controls ( 56 ( 7 ) % v 65 ( 7 ) % , p < 0.05 ) .
RESULTS	In response to exercise , increases in right ventricular end diastolic ( 155 ( 55 ) ml to 163 ( 57 ) ml , p < 0.05 ) and right ventricular end systolic volumes ( 70 ( 34 ) ml to 75 ( 36 ) ml , p < 0.05 ) were observed in patients .
RESULTS	Furthermore , right and left ventricular stroke volumes and ejection fraction did not increase significantly in patients .
RESULTS	Changes in right ventricular ejection fraction with exercise correlated with diminished exercise capacity ( r = 0.43 , p < 0.05 ) .
CONCLUSIONS	In patients with atrially corrected TGA , MRI showed an abnormal response to exercise of both systemic right and left ventricles .
CONCLUSIONS	Exercise MRI provides a tool for close monitoring of cardiovascular function in these patients , who are at risk for late death .

###22311406
OBJECTIVE	To examine the effect of a Chinese medicinal herbal formula ( Feitai Capsule , ) on the quality of life ( QOL ) and progression-free survival ( PFS ) of patients with unresectable non-small cell lung cancer ( NSCLC ) .
METHODS	Sixty-two patients were randomly divided into the treatment group ( 31 cases ) and the control group ( 31 cases ) .
METHODS	For the treatment group , 4 capsules ( 1.2 g/capsule ) of Feitai Capsule were administered 3 times a day after meals for 3 weeks ; then no drug was administered for 1 week .
METHODS	This schedule was continued for at least 3 more cycles ( 12 weeks totally ) .
METHODS	If there were no obvious toxic reactions , the treatment was extended .
METHODS	The patients were evaluated at least once every 8 weeks until progressive disease ( PD ) .
METHODS	For the control group , the regular follow-up and evaluation were performed at least once every 8 weeks until PD .
METHODS	Clinical symptoms , objective response , physical constitution and energy , QOL , and PFS were evaluated regularly .
METHODS	Analysis of variance ( ANOVA ) , a non-parametric test , and analysis of covariance were used to compare clinical features , amelioration of clinical symptoms , physical constitution and energy , and QOL .
METHODS	Kaplan-Meier analysis was used to compare the two-group PFS .
RESULTS	Sixty patients finished the final evaluation , with 30 patients in each group .
RESULTS	Baseline characters between groups were not significantly different ( P > 0.05 ) .
RESULTS	The control group had a 36.7 % improvement in clinical symptoms , while the treatment group had a 73.3 % improvement .
RESULTS	This difference was statistically significant ( Z = -2.632 , P = 0.008 ) .
RESULTS	The control group had a 26.7 % improvement in the Karnofsky performance status ( KPS ) , while the treatment group had a 53.4 % improvement .
RESULTS	This was also significantly different ( Z = -2.182 , P = 0.029 ) .
RESULTS	A comparative analysis indicated a positive correlation ( r = 0.917 , P < 0.001 ) .
RESULTS	Compared with the control group , QOL in the treatment group was significantly improved , except in the social/family condition and doctor-patient relationship indicators .
RESULTS	The PFS of the treatment group and control group were 6.23 months and 4.67 months , respectively ( P = 0.048 ) .
CONCLUSIONS	Feitai Capsule , a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients .

###19530976
OBJECTIVE	To determine whether verteporfin photodynamic therapy ( PDT ) can safely reduce the risk of vision loss in patients with subfoveal occult with no classic choroidal neovascularization ( CNV ) due to age-related macular degeneration .
METHODS	Eligible patients were > or = 50 years of age with lesion size < or = 6 disc areas and best-corrected vision 20/40-20 / 200 .
METHODS	A total of 364 patients with occult with no classic CNV were randomly assigned 2 : 1 to verteporfin PDT ( n = 244 ) or placebo ( n = 120 ) .
METHODS	The primary outcome measures were loss of > or = 15 and > or = 30 letters of visual acuity ( VA ) from baseline at 12 and 24 months .
BACKGROUND	This study was registered with ClinicalTrials.gov on 20 July 2005 .
BACKGROUND	ClinicalTrials.gov identifier : NCT00121407 .
RESULTS	A total of 37 % and 47 % of verteporfin-treated patients versus 45 % and 53 % of placebo recipients lost > or = 15 letters of VA at month 12 and month 24 , respectively ; 16 % and 23 % of verteporfin-treated patients versus 17 % and 25 % of placebo recipients lost > or = 30 letters at month 12 and month 24 , respectively .
RESULTS	These differences were not statistically significant .
RESULTS	Four ( 1.6 % ) verteporfin-treated patients and one placebo patient ( who received verteporfin in error ) experienced an acute severe VA decrease ; all five patients recovered some degree of vision .
RESULTS	No unexpected ocular or systemic adverse events were identified .
CONCLUSIONS	Verteporfin PDT in the treatment of occult with no classic CNV was safe and well-tolerated .
CONCLUSIONS	The differences between the two groups in the primary efficacy variables were not significant .
CONCLUSIONS	Baseline characteristics and patient selection methods may have contributed to the small treatment effect .

###20137430
OBJECTIVE	To study the conjunctival bacteria flora in eyes of patients undergoing cataract surgery and determine the efficacy of reducing conjunctival bacteria with different methods .
METHODS	A total of 135 eyes of 135 patients scheduled to undergo cataract surgery were randomized into 3 groups ( 45 each ) .
METHODS	They received topical prophylactic treatment with three different kinds of antibiotics ( 0.5 % levofloxacin , 0.3 % levofloxacin and 0.3 % tobramycin ) .
METHODS	Each group was randomized into one-day group and three-day group .
METHODS	All the eyes underwent irrigation of fornices with 2.5 % povidone-iodine ( PVI ) before surgery .
METHODS	Conjunctival cultures were obtained at various time points .
RESULTS	The total positive rate of conjunctival cultures was 66.7 % .
RESULTS	The eliminating rate of conjunctival bacteria in one-day groups were 72.7 % , 72.7 % and 61.1 % ( P = 0.667 ) while 70.0 % , 70.0 % and 55.5 % in the three-day groups respectively ( P = 0.751 ) .
RESULTS	Immediately after PVI irrigation , the eliminating rate in one-day groups added up to 86.4 % , 77.3 % and 88.9 % ( P = 0.564 ) as compared with 90.0 % , 80.0 % and 66.7 % in the three-day groups respectively ( P = 0.749 ) .
RESULTS	And there was no statistically significant difference between one-day groups and three-day groups in the eliminating rate of conjunctival bacterial after the topical antibiotic application .
RESULTS	The MIC test revealed that the antibiotic sensitivity of Gram-positive cocci ( G ( + ) C ) to levofloxacin was 94.8 % versus 74.1 % to tobramycin ( P = 0.000 ) while the antibiotic sensitivity of Gram-negative bacillus ( G ( - ) B ) to levofloxacin was 94.4 % versus 83.3 % to tobramycin ( P = 0.289 ) .
CONCLUSIONS	G ( + ) C accounts for the most among the conjunctival bacteria flora in eyes of patients undergoing cataract surgery and there is no statistically significant difference in the efficacy of reducing conjunctival bacteria between the application of topical antibiotic for one day and for three days .
CONCLUSIONS	Both G ( + ) C and G ( - ) B retain a high sensitivity to levofloxacin .
CONCLUSIONS	Topical antibiotic in combination with 2.5 % PVI irrigation further reduces conjunctival bacteria .

###17927463
OBJECTIVE	To determine the effectiveness of a telephone reminder to increase pneumococcal vaccination in a population that had received mailed reminders and to evaluate whether the intervention effect is similar for clinics serving primarily non-Hispanic black or non-Hispanic white patient populations .
METHODS	Randomized trial within a managed care network .
METHODS	All unvaccinated patients 18 years and older with chronic medical conditions and 65 years and older without chronic medical conditions ( N = 6106 ) were randomized to receive telephone intervention or standard care and followed up for 6-month vaccination status .
METHODS	The intervention was a telephone call initiated by a nurse to inform patients that pneumococcal vaccination was recommended and was a covered benefit of their insurance .
RESULTS	Intervention patients were 2.3 times as likely to be vaccinated during the study period than control patients ( P < .001 ) .
RESULTS	The success of telephone intervention versus control was similar across clinics ( P = .16 ) and across the chronic disease and elderly groups ( P = .14 ) .
RESULTS	In subanalyses of individuals reached by telephone intervention , unvaccinated black subjects were less likely to be vaccinated during the study than unvaccinated white subjects ( 34 % vs 25 % , P = .03 ) .
RESULTS	Nurse staff time for telephone intervention cost $ 147.35 per additional patient vaccinated .
CONCLUSIONS	Telephone intervention was successful at increasing vaccination rates in a diverse managed care population that had already received mailed reminders .
CONCLUSIONS	Tailored messaging for pneumococcal vaccination through telephone reminders increases patient demand for vaccination and should be implemented by managed care organizations seeking to increase their vaccination rates .

###9661687
BACKGROUND	No effective treatment exists in the United States for acute attacks of hereditary angioedema ( HAE ) .
METHODS	To evaluate the efficacy and safety of C1 inhibitor concentrate in treating HAE , a large primary care and referral center hospital conducted a randomized , placebo-controlled , double-blind trial with intent-to-treat analysis .
METHODS	Of the 36 patients enrolled in the study , 23 received treatment , and 22 completed the trial .
METHODS	C1 inhibitor concentrate or albumin ( placebo ) infusions were administered in a blind fashion to HAE patients who came to the hospital for treatment no later than 5 hours after an attack began .
RESULTS	Relief was almost twice as fast in persons receiving C1 inhibitor concentrate than in the controls : 7.62 hours ( mean ; SD 7.08 ) versus 15.35 hours ( mean ; SD 8.31 ) , respectively .
RESULTS	The difference for time-to-relief was highly significant ( p = 0.007 , Mann-Whitney U test ) .
RESULTS	The median time-to-relief was 6.17 hours ( interquartile range 0.33-15 .35 ) in the treatment group and 15.35 hours ( interquartile range 14.00-22 .83 ) in the control group .
RESULTS	Resolution of symptoms was one-third faster in the C1 inhibitor concentrate group than in the placebo group : 23.98 hours ( mean ; SD 14.81 ) and 34.58 hours ( mean ; SD 13.56 ) , respectively ( p = 0.09 , Mann-Whitney U test ) .
RESULTS	Recovery of functional C1 inhibitor was 119.65 percent ( mean ; SD 50.80 ) , and half-life was 37.87 hours ( mean ; SD 19.75 ) .
RESULTS	Recovery of antigenic C1 inhibitor was 147.75 percent ( mean ; SD 97.68 ) , and half-life was 24.01 hours ( mean ; SD 9.70 ) .
RESULTS	There were no viral infections or serious adverse effects from the drug after 70 attacks in the treatment group and 96 attacks in the control group .
CONCLUSIONS	C1 inhibitor concentrate is a safe , effective treatment for acute attacks of HAE .

###23646838
OBJECTIVE	Despite long-standing social psychological research supporting the influence of injunctive norms ( i.e. , what is commonly approved or disapproved ) on behavior , support for this influence on health behaviors is limited .
OBJECTIVE	We examined the utility of correcting misperceptions of injunctive norms for improving sun protection and whether changes in attitudes mediated the injunctive norm-intention relationship .
METHODS	At baseline 263 community residing primarily White women , aged 37 to 77 years , reported their beliefs about sun protection and tanning and their perceptions of `` typical women 's '' approval of sun protection versus tanning .
METHODS	Women underestimated approval of sun protection and overestimated approval of tanning .
METHODS	In a randomized trial , 189 of these women received either information about sun protection or information plus personalized normative feedback ( PNF ) .
METHODS	PNF compared each woman 's own perceptions of typical women 's approval of tanning and sun protection with actual normative values , both measured at baseline .
METHODS	PNF communicated that most women approve of others who sun protect .
RESULTS	PNF led to more positive sun protection injunctive norms , attitudes , and intentions at immediate posttest and more positive intentions and self-reported behavior at 4-week follow-up .
RESULTS	Baseline discrepancy between a woman 's beliefs and actual normative values related negatively to changes in sun protection in the control condition but positively in the PNF condition .
RESULTS	As hypothesized , changes in attitudes partially mediated the influence of PNF on changes in intentions .
CONCLUSIONS	The present research demonstrates the utility of correcting injunctive norm misperceptions for promoting healthy behaviors .
CONCLUSIONS	That attitudes changed in response to PNF and mediated the norm-intention relationship suggests a method for influencing attitudes that may limit reactance .

###12824973
OBJECTIVE	The purpose of this study was to evaluate the effectiveness and endocrine response of oral contraceptive ovarian suppression followed by clomiphene citrate in patients who previously were clomiphene citrate resistant .
METHODS	Forty-eight patients from a private tertiary infertility clinic were assigned randomly prospectively to either group 1 ( oral contraceptive/clomiphene citrate ) , which received continuous oral contraceptives followed by clomiphene citrate , or to group 2 ( control ) received no treatment in the cycle before clomiphene citrate treatment .
METHODS	On day 3 , 17 beta-estradiol , follicle-stimulating hormone , luteinizing hormone , and androgens were assayed before and after treatment .
METHODS	Follicle growth , ovulation , and pregnancy were evaluated .
METHODS	The Student t test and analysis of variance were used for statistical significance .
RESULTS	The oral contraceptive/clomiphene citrate group had a significantly higher percentage of patients who ovulated and of ovulatory cycles and pregnancies .
RESULTS	Significantly lower levels of 17 beta-estradiol , luteinizing hormone , and androgen levels were seen in the oral contraceptive/clomiphene citrate group , with no significant changes in group 2 .
CONCLUSIONS	Suppression of the ovary with oral contraceptives results in excellent rates of ovulation and pregnancy in patients who previously were resistant to clomiphene citrate .
CONCLUSIONS	The decreases in ovarian androgens , luteinizing hormone , and 17 beta-estradiol may be responsible for the improved response .

###24742399
OBJECTIVE	We explore gender differences in older adults ' appraisals of positive and negative aspects of their marriages , examine how these appraisals relate to global marital satisfaction , and identify distinctive marital profiles associated with global satisfaction in men and women .
METHODS	Data are from the Changing Lives of Older Couples Study ( n = 1,110 ) .
METHODS	We used a variant of principal components analysis to generate marital quality profiles , based on one 's endorsement of positive and negative marital characteristics .
METHODS	OLS regression was used to detect associations between marital profiles and global marital satisfaction .
RESULTS	Men offered more positive marital assessments than women , particularly on items reflecting positive treatment by one 's wife .
RESULTS	Three marital quality profiles emerged : Positive , Positive-Negative , and Negative .
RESULTS	Although marital satisfaction was best explained by positive appraisals in both genders , they were less important for men than for women .
RESULTS	The negative profile showed a tendency for a stronger prediction in men .
CONCLUSIONS	Prior studies show small differences in men 's and women 's global marital satisfaction .
CONCLUSIONS	Our work provides evidence that the presence and magnitude of such gender differences may vary based on the specific marital component considered .
CONCLUSIONS	We discuss ways that gender shapes marital interactions , expectations , and perceptions , and the implications of our results for the well-being of married older adults .

###19560195
OBJECTIVE	The objectives of this study were to determine the bond strength of powder-liquid and paste opaquers with different chemical compositions and viscosity to a metal substructure when they were applied in two thicknesses and to evaluate the failure modes after the bond strength test .
METHODS	Titanium plates ( 51 mm x 25 mm x 1mm ) ( n ( plates ) = 25 , N = 80 , n = 10 per group ) were conditioned with chairside silica coating ( CoJet-Sand , 30 microm silica coated Al ( 2 ) O ( 3 ) ) from a distance of approximately 10mm at a pressure of 2.8 bar for 15 s/cm ( 2 ) and silanized .
METHODS	Four types of opaquers , namely one powder-liquid ( Sinfony , 3M ESPE ) , and three paste opaquers [ ( Cimara , Voco ) , ( Monopaque , Ivoclar Vivadent ) , ( Cavex Experimental , Cavex ) ] were applied either in 0.25 or 0.50 mm thicknesses using standard polyethylene molds and photo-polymerized .
METHODS	Resin composite ( Quadrant Posterior Dense , Cavex ) was applied incrementally and photo-polymerized .
METHODS	The specimens were thermocycled ( 5-55 degrees C , 6000 cycles ) prior to shear bond strength test ( 1mm/min ) .
METHODS	Failure types were analyzed using an optical microscope and scores were given according to the modified Adhesive Remnant Index ( ARI ) ( Score 0 = no opaquer on the surface , Score 1 = < 1/2 covered with opaquer , Score 2 = > 1/2 covered with opaquer , Score 3 = completely covered with opaquer ) .
RESULTS	While thickness did not significantly affect the bond strength results ( p = 0.523 ) , type of opaquers had a significant influence on the results ( p < 0.01 ) ( Univariate ANOVA , Tukey 's test ) .
RESULTS	Interaction terms between thickness and opaquer type were significant ( p < 0.01 ) .
RESULTS	Debonded specimens during thermocycling were considered as 0 MPa .
RESULTS	At both 0.25 and 0.5 mm thicknesses , powder-liquid based opaquer ( Sinfony ) showed significantly higher results ( 8.4 + / -5.6 and 8.4 + / -4.9 MPa , respectively ) than those of other opaquers ( 1.4 + / -1 to 4.3 + / -3.8 MPa ) ( p < 0.05 ) .
RESULTS	Only when Cimara was applied in 0.25 mm ( 6.9 + / -4.2 MPa ) , there were no significant differences with Sinfony ( p > 0.05 ) .
RESULTS	The lowest results in both thicknesses were obtained from Monopaque ( 4 + / -3.8 to 1.6 + / -1 MPa , respectively ) and Cavex ( 1.4 + / -1 to 4.2 + / -2.9 MPa , respectively ) paste opaquers .
RESULTS	In all opaquers , the incidence of Score 0 ( 30 ) was more frequent followed by Score 1 ( 27 ) and Score 2 ( 20 ) .
CONCLUSIONS	The use of powder-liquid opaquer in order to mask the metal in repair actions provided higher bond strength than those of the paste opaquers in both thin and thick applications .
CONCLUSIONS	In all opaquers , the incidence of adhesive failure between the opaquer and the metal was more common implying inadequate adhesion .

###17998493
BACKGROUND	There is a paucity of data on the efficacy of nitrofurantoin for the treatment of acute uncomplicated cystitis in regimens shorter than 7 days .
BACKGROUND	Evidence-based use of this drug is increasingly important as trimethoprim-sulfamethoxazole resistance among uropathogens increases .
METHODS	To assess the efficacy of nitrofurantoin vs trimethoprim-sulfamethoxazole , 338 women aged 18 to 45 years with acute uncomplicated cystitis were randomized to open-label treatment with either trimethoprim-sulfamethoxazole , 1 double-strength tablet twice daily for 3 days , or nitrofurantoin , 100 mg twice daily for 5 days .
METHODS	Clinical cure 30 days after therapy was the main outcome measure .
METHODS	Secondary outcomes included clinical and microbiological cure rates 5 to 9 days after therapy and , for trimethoprim-sulfamethoxazole-treated women , clinical cure stratified by the trimethoprim-sulfamethoxazole susceptibility of the uropathogen .
RESULTS	Clinical cure was achieved in 79 % of the trimethoprim-sulfamethoxazole group and in 84 % of the nitrofurantoin group , for a difference of -5 % ( 95 % confidence interval , -13 % to 4 % ) .
RESULTS	Clinical and microbiological cure rates at the first follow-up visit were also equivalent between the 2 groups .
RESULTS	In the trimethoprim-sulfamethoxazole arm , 7 of 17 women ( 41 % ) with a trimethoprim-sulfamethoxazole-nonsusceptible isolate had a clinical cure compared with 84 % of women with a trimethoprim-sulfamethoxazole-susceptible isolate ( P < .001 ) .
CONCLUSIONS	A 5-day course of nitrofurantoin is equivalent clinically and microbiologically to a 3-day course of trimethoprim-sulfamethoxazole and should be considered an effective fluoroquinolone-sparing alternative for the treatment of acute cystitis in women .

###21690120
OBJECTIVE	In this study we sought to evaluate the efficacy of motivational interviewing ( MI ) compared with structured brief advice ( SBA ) for adolescent smoking behavior change .
METHODS	Participants ( N = 355 ) were randomly assigned to 5 sessions of either MI or SBA .
METHODS	The primary outcomes were attempts to reduce and to quit smoking , smoking reduction , and cotinine-validated 7-day point-prevalence smoking abstinence at the end of treatment ( week 12 ) and the 24-week follow-up .
RESULTS	White adolescents were 80 % less likely to attempt to cut back ( odds ratio [ OR ] : 0.21 ; confidence interval [ CI ] : 0.08-0 .53 ) and > 80 % less likely to attempt to quit smoking compared with black adolescents ( OR : 0.17 [ CI : 0.06-0 .46 ] ) .
RESULTS	Adolescents who were at least planning to cut back or quit smoking at baseline were almost 3 times more likely to attempt to cut back ( OR : 2.87 [ CI : 1.26-6 .52 ] ) and to attempt to quit smoking ( OR : 3.13 [ CI : 1.19-8 .26 ] ) .
RESULTS	Adolescents who received MI were 60 % less likely than adolescents who received SBA to try to quit smoking ( OR : 0.41 [ CI : 0.17-0 .97 ] ) .
RESULTS	However , adolescents who received MI showed a greater reduction in cigarettes smoked per day than adolescents who received SBA ( 5.3 vs 3.3 fewer cigarettes per day ) .
RESULTS	There were no statistically significant differences between MI and SBA in smoking abstinence ( 5.7 % vs 5.6 % , respectively ) .
CONCLUSIONS	The effects of MI on adolescent smoking behavior change are modest , and MI may best fit within a multicomponent smoking cessation treatment approach in which behavior change skills can support and promote smoking behavior change decisions .

###15921508
BACKGROUND	Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia .
BACKGROUND	Simultaneous treatment with multiple antipsychotics ( polypharmacy ) is suggested by some expert consensus guidelines as the last resort after exhausting monotherapy alternatives .
BACKGROUND	This study assessed the annual rate and duration of antipsychotic monotherapy and its inverse , antipsychotic polypharmacy , among schizophrenia patients initiated on commonly used atypical antipsychotic medications .
METHODS	Data were drawn from a large prospective naturalistic study of patients treated for schizophrenia-spectrum disorders , conducted 7/1997 -9 / 2003 .
METHODS	Analyses focused on patients ( N = 796 ) who were initiated during the study on olanzapine ( N = 405 ) , quetiapine ( N = 115 ) , or risperidone ( N = 276 ) .
METHODS	The percentage of patients with monotherapy on the index antipsychotic over the 1-year post initiation , and the cumulative number of days on monotherapy were calculated for all patients and for each of the 3 atypical antipsychotic treatment groups .
METHODS	Analyses employed repeated measures generalized linear models and non-parametric bootstrap re-sampling , controlling for patient characteristics .
RESULTS	During the 1-year period , only a third ( 35.7 % ) of the patients were treated predominately with monotherapy ( > 300 days ) .
RESULTS	Most patients ( 57.7 % ) had at least one prolonged period of antipsychotic polypharmacy ( > 60 consecutive days ) .
RESULTS	Patients averaged 195.5 days on monotherapy , 155.7 days on polypharmacy , and 13.9 days without antipsychotic therapy .
RESULTS	Olanzapine-initiated patients were significantly more likely to be on monotherapy with the initiating antipsychotic during the 1-year post initiation compared to risperidone ( p = .043 ) or quetiapine ( p = .002 ) .
RESULTS	The number of monotherapy days was significantly greater for olanzapine than quetiapine ( p < .001 ) , but not for olanzapine versus risperidone , or for risperidone versus quetiapine-initiated patients .
CONCLUSIONS	Despite guidelines recommending the use of polypharmacy only as a last resort , the use of antipsychotic polypharmacy for prolonged periods is very common during the treatment of schizophrenia patients in usual care settings .
CONCLUSIONS	In addition , in this non-randomized naturalistic observational study , the most commonly used atypical antipsychotics significantly differed on the rate and duration of antipsychotic monotherapy .
CONCLUSIONS	Reasons for and the impact of the predominant use of polypharmacy will require further study .

###23446769
METHODS	Multicenter randomized controlled trial .
OBJECTIVE	To compare the efficacy and safety of balloon kyphoplasty ( BKP ) with nonsurgical management ( NSM ) during 24 months in patients with painful vertebral compression fractures ( VCFs ) .
BACKGROUND	Recently , several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs .
BACKGROUND	Few of these trials report on the surgical aspects and radiographical vertebral deformity results .
METHODS	Adults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP ( n = 149 ) or NSM ( n = 151 ) .
METHODS	Surgical parameters , subjective quality of life assessments and objective functional ( timed up and go ) and radiographical assessments were collected .
RESULTS	Compared with NSM , the BKP group had greater improvements in SF-36 physical component summary ( PCS ) scores at 1 month ( 5.35 points ; 95 % CI , 3.41-7 .30 ; P < 0.0001 ) and when averaged across the 24 months ( overall treatment effect 2.71 points ; 95 % CI , 1.34-4 .09 ; P = 0.0001 ) .
RESULTS	The kyphoplasty group also had greater functionality by assessing timed up and go ( overall treatment effect -2.49 s ; 95 % CI , -0.82 to -4.15 ; P = 0.0036 ) .
RESULTS	At 24 months , the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group ( average 3.13 of correction for kyphoplasty compared with 0.82 in the control , P = 0.003 ) .
RESULTS	Number of baseline prevalent fractures ( P = 0.0003 ) and treatment assignment ( P = 0.004 ) are the most predictive variables for PCS improvement ; however , in patients who underwent BKP , there may also be a link with kyphotic angulation .
RESULTS	In BKP , the highest quart for kyphotic angulation correction had higher PCS improvement ( 13.4 points ) than the quart having lowest correction of angulation ( 7.40 points , P = 0.0146 for difference ) .
RESULTS	The most common adverse events temporally related to surgery ( i.e. , within 30 d ) were back pain ( 20 BKP , 11 NSM ) new VCF ( 11 BKP , 7 NSM ) , nausea/vomiting ( 12 BKP , 4 NSM ) , and urinary tract infection ( 10 BKP , 3 NSM ) .
RESULTS	Several other adverse events were possibly related to patient positioning in the operating room .
CONCLUSIONS	Compared with NSM , BKP improves patient quality of life and pain averaged during 24 months and results in better improvement of index vertebral body kyphotic angulation .
CONCLUSIONS	Perioperative complications may be reduced with more care in patient positioning .
METHODS	2 .

###12487015
OBJECTIVE	The purpose of this study was to assess the use of nicotine replacement therapy ( NRT ) in a nurse-managed smoking cessation program .
METHODS	A cohort design nested within the WINS randomized clinical trial was used with follow-up at 2 , 7 , 21 , 28 , and 90 days .
METHODS	The study took place in 10 hospitals in the San Francisco Bay Area .
METHODS	Participants included 142 women hospitalized with cardiovascular disease ( CVD ) .
METHODS	The outcome measure was the use of NRT after having been assessed as eligible for its use .
METHODS	NRT was used as an adjunct in the behavioral intervention protocol .
METHODS	NRT was recommended during the hospital intervention and during the 90-day outpatient phase .
RESULTS	Of 142 women in the intervention group , 127 met the criteria for NRT use .
RESULTS	During the 5 follow-up assessments , the reported NRT use ranged from 9 % to 22 % .
CONCLUSIONS	A low NRT use rate among women with CVD is evident .
CONCLUSIONS	The results suggest that future research about NRT myths pertaining to women is needed .
CONCLUSIONS	Nurses can help patients dispel these myths and prevent smoking relapse in women with CVD .

###11783240
OBJECTIVE	To observe the effect of Chinese herbal medicine on hepatic artery chemoembolization caused liver damage .
METHODS	One hundred and ten patients , who received hepatic artery chemoembolization , were divided into two groups , 60 patients in the treated group were treated with Qinggan Jiedu Sanjie Decoction and the other 50 Patients in the control group treated with routine western medicine .
METHODS	The changes of liver function , cirrhosis incidence and exacerbation rate of both groups were observed .
RESULTS	The total liver function deterioration rate of the treated group , according to Child 's grading standard , was 46.67 % , while that of the control group was 68.00 % , the former was much lower than the latter ( P < 0.05 ) .
RESULTS	The cirrhosis incidence and exacerbation rate in the treated group were 35.00 % ( 7/20 ) and 50.00 % ( 20/40 ) respectively , while in the control group , they were 65.00 % ( 13/20 ) and 76.67 % ( 23/30 ) respectively .
RESULTS	The difference between the two groups was also significant ( P < 0.05 ) .
CONCLUSIONS	Qinggan Jiedu Sanjie Decoction has some effect on alleviating and preventing hepatic damage caused by hepatic artery chemoembolization .

###8004592
BACKGROUND	A major issue in decisions regarding screening women for breast cancer concerns ages of coverage , in particular , whether routine mass screening programs with mammography should cover women aged 40-49 .
BACKGROUND	Interpretation of results of studies on this question is affected by differences in design , adequacy of sample size , quality of mammography , period of follow-up , and other methodologic and content issues .
METHODS	Experience in eight randomized controlled trials ( RCTs ) conducted over the past 30 years in the United States , Europe , and Canada were assessed , and problems influencing their conclusions were considered .
RESULTS	The age groups studied in these RCTs varied , from 40-64 in the Health Insurance Plan ( HIP ) study to 40-74 in the Swedish two-country trials .
RESULTS	In addition , they differed in periodicity and modalities of screening , with the HIP and the Canadian National Breast Screening Study providing annual examinations with mammography and clinical breast examination , and most of the other trials scheduling longer intervals between examinations with mammography alone .
RESULTS	Great consistency is found , however , in the results for women aged 50-69 , as all of these studies showed a reduction in breast cancer mortality in this age group , suggesting about a 30 % decrease .
RESULTS	For women aged 40-49 , the studies showed no benefit 5-7 years after entry and an uncertain benefit 10-12 years after entry , and only one study offered information on long term effects .
RESULTS	Additional follow-up is needed .
RESULTS	Adequate data are not available for women 70 and older .
CONCLUSIONS	Public health policy on mass screening with mammography for women aged 40-49 is questionable .
CONCLUSIONS	At this time , the emphasis should be on physicians advising women about the uncertainty of the benefits of routine mammography when referrals are being considered .

###25643051
OBJECTIVE	This study was aimed at evaluating the clinical efficacy and safety of transcutaneous electrical acupoint stimulation ( TEAS ) to treat muscle spasticity after brain injury ( Chinese Clinical Trial Registry : ChiCTR-TRC-11001310 ) .
METHODS	A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups : 100 , 2 , and 0 Hz ( sham ) TEAS .
METHODS	The acupoints Hegu ( LI4 ) -- Yuji ( LU10 ) and Zusanli ( ST36 ) -- Chengshan ( BL57 ) on the injured side were stimulated at 0 , 2 , or 100 Hz , 5 times per week for 4 weeks .
METHODS	The patients were followed up for 1 and 2 months after the treatments .
METHODS	The effects of the treatments on muscle spasticity at the wrist , thumb , the other 4 fingers , elbow , shoulder , knee , and ankle were evaluated by the Modified Ashworth Scale , and the effects on disability were assessed by the Disability Assessment Scale .
METHODS	The walking capability was evaluated by the Holden functional ambulation classification score .
METHODS	The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index .
METHODS	The safety of the treatments administered was also monitored .
RESULTS	The wrist spasticity was significantly reduced from baseline at weeks 2 , 3 , and 4 of treatment and at the 1 - and 2-month follow-up visits in the 100 Hz group ( P < 0.01 ) .
RESULTS	Compared with 2 Hz or sham TEAS , 100 Hz TEAS decreased wrist spasticity at weeks 2 , 3 , and 4 of treatment and 1 month after treatment ( P < 0.001 ) .
RESULTS	The other endpoints were not affected by the treatments .
RESULTS	No treatment-emergent adverse events were reported during treatments and follow-up visits .
CONCLUSIONS	TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury , although large-scale studies are required to further verify the findings .
BACKGROUND	Chinese Clinical Trial Registry ChiCTR-TRC-11001310 http://www.chictr.org .

###18024166
OBJECTIVE	Nocturnal positive pressure ventilation ( PPV ) has been shown to be effective in patients with impaired left ventricular ejection fraction ( LVEF ) and Cheyne-Stokes respiration ( CSR ) .
OBJECTIVE	We investigated the effect of a bi-level PPV and adaptive servo ventilation on LVEF , CSR , and quantitative sleep quality .
METHODS	Thirty-seven patients ( New York heart association [ NYHA ] II-III ) with LVEF < 45 % and CSR were investigated by electrocardiography ( ECG ) , echocardiography and polysomnography .
METHODS	The CSR index ( CSRI ) was 32.3 + / -16.2 / h. Patients were randomly treated with bi-level PPV using the standard spontaneous/timed ( S/T ) mode or with adaptive servo ventilation mode ( AutoSetCS ) .
METHODS	After 6 weeks , 30 patients underwent control investigations with ECG , echocardiography , and polysomnography .
RESULTS	The CSRI decreased significantly to 13.6 + / -13.4 / h. LVEF increased significantly after 6 weeks of ventilation ( from 25.1 + / -8.5 to 28.8 + / -9.8 % , p < 0.01 ) .
RESULTS	The number of respiratory-related arousals decreased significantly .
RESULTS	Other quantitative sleep parameters did not change .
RESULTS	The Epworth sleepiness score improved slightly .
RESULTS	Daytime blood pressure and heart rate did not change .
RESULTS	There were some differences between bi-level PPV and adaptive servo ventilation : the CSRI decreased more in the AutoSetCS group while the LVEF increased more in the bi-level PPV group .
CONCLUSIONS	Administration of PPV can successfully attenuate CSA .
CONCLUSIONS	Reduced CSA may be associated with improved LVEF ; however , this may depend on the mode of PPV .
CONCLUSIONS	Changed LVEF is evident even in the absence of significant changes in blood pressure .

###21349878
BACKGROUND	Treatment based on ultrasound ( US ) and colour Doppler ( CD ) findings in midportion Achilles tendinosis has shown promising results .
BACKGROUND	In a randomised study on a small patient material , similar short-term clinical results were demonstrated with surgery outside the tendon and sclerosing polidocanol injections , but surgical treatment led to a faster return to activity .
OBJECTIVE	To evaluate the clinical results of US and CD-guided mini-surgery ( scraping ) outside the ventral tendon in a larger patient material and , in a randomised study , compare two different techniques for surgical scraping .
METHODS	103 patients ( 66 men , 37 women ) , mean age 43 years ( range 24-77 ) , with midportion tendinosis in 125 Achilles tendons were included .
METHODS	Patients from a large group ( 88 tendons ) , and a randomised study ( 37 tendons ) , were in local anaesthesia treated with a US and CD-guided new surgical approach outside the ventral tendon .
METHODS	All patients in the large group , and one arm of the randomised study , were treated open with a scalpel , while the other arm of the randomised study were treated percutaneously .
METHODS	Pain during Achilles tendon loading activity ( Visual Analogue Scale ( VAS ) ) , and satisfaction with treatment , were evaluated .
RESULTS	Before surgery , the mean VAS was 73 .
RESULTS	After surgery ( follow-up mean 18 months , range 6-33 ) , the mean VAS was 3 in 111 tendons ( 89 % ) from satisfied patients back in full Achilles tendon loading activity .
RESULTS	In the randomised study , there were no significant differences in the results between open treatment with a scalpel and percutaneous treatment with a needle .
CONCLUSIONS	US and CD-guided scraping show good short-term results in midportion Achilles tendinosis .

###24495355
BACKGROUND	Declining cognitive function is relatively common and increasingly prevalent .
BACKGROUND	Studies have shown that different nutrients ( e.g. , Ginkgo biloba and vitamin E ) appear to be effective at improving memory and concentration , while less is known about their effect on immunity .
METHODS	This study investigated the effect of Ginkgo Synergy ( ) plus Choline ( n = 33 ) and OPC Synergy ( ) plus Catalyn ( ) ( n = 31 ) versus placebo ( n = 33 ) in a 6-month , randomized , double-blind trial on cognitive and immune functioning among English-speaking , non-smoking , healthy older adults .
METHODS	The Stroop Color and Word Test , Trail Making Test A and B , Controlled Oral Word Association , Hopkins Verbal Learning , Mini-Mental State Exam , and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning .
METHODS	Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning .
METHODS	Data were analyzed with linear mixed modeling .
RESULTS	No serious adverse events were noted in this study .
RESULTS	According to time on the Trail Making Test-B , the Ginkgo Synergy ( ) plus Choline arm showed improvement from baseline to 3 months follow-up ( mean difference = 24.2 ; SE = 6.4 ; 95 % CI : 8.6 , 39.7 ; p = 0.01 ) .
RESULTS	On the Controlled Oral Word Association Trial-S , the scores significantly increased for the Ginkgo Synergy ( ) plus Choline arm from baseline to 6 months follow-up ( mean difference = 2.1 ; SE = 0.8 ; 95 % CI : 0.2 , 3.9 ; p < 0.05 ) and for the OPC Synergy ( ) plus Catalyn ( ) arm from baseline to 3 months follow-up ( mean difference = 2.1 ; SE = 0.8 ; 95 % CI : 0.2 , 4.0 ; p < 0.05 ) .
RESULTS	Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy ( ) plus Choline arm ( mean difference = 120.7 ; SE = 28.4 ; 95 % CI : 62.6 , 178.8 ; p < 0.001 ) .
CONCLUSIONS	Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits .
CONCLUSIONS	Our trial was registered with clinicaltrials.gov ( ID : NCT01672359 ) .
CONCLUSIONS	This study was supported by a grant from Standard Process , Inc. .

###15763054
OBJECTIVE	To evaluate the immuno-modulatory effect of short course administration of somatostatin ( stilamin ) continuously at early stage in patients with severe acute pancreatitis ( SAP ) .
METHODS	Thirty-nine patients with SAP ( 22 men , 17 women ; the middle age was 49 years ) were randomly allocated into control group ( 20 patients treated with non-surgical integrated traditional Chinese and Western medicine ) and treatment group ( 19 patients treated with somatostatin administered intravenously at a dosage of 250 mug/h for consecutive 72 hours as well as the treatment for the control group ) .
METHODS	Laboratory parameters , including the expressions of CD ( 3 ) , CD ( 4 ) and CD ( 8 ) in lymphocytes ( tested by flow cytometry ) and C reactive protein ( CRP ) , and indexes of therapeutic effect , including the occurrence of organic dysfunction , local complication and mortality between the two groups were compared .
METHODS	Another group of 30 healthy volunteers ( 19 men , 11 women ; the middle age was 47 years ) were recruited for testing the normal levels of CD ( 3 ) , CD ( 4 ) and CD ( 8 ) .
RESULTS	( 1 ) The levels of CD ( 3 ) , CD ( 4 ) and CD ( 4 ) / CD ( 8 ) in lymphocytes before treatment in both groups were significantly lower than those in the healthy subjects ( P < 0.05 ) , but there were no statistical differences between the two groups .
RESULTS	At the 4th day , CD ( 3 ) , CD ( 4 ) and CD ( 4 ) / CD ( 8 ) increased significantly in the treatment group ( P < 0.05 ) while no changes in the control group ; the levels of CD ( 4 ) and CD ( 4 ) / CD ( 8 ) in the treatment group were also higher than those in the control group ( P < 0.05 ) .
RESULTS	( 2 ) The CRP levels of the 2 groups showed no statistical difference before and 4 days after the treatment , but the CRP level in the treatment group was significantly lower than that in the control group at the 7th day ( P < 0.05 ) .
RESULTS	WBC count , serum levels of amylase , lipase , lactate dehydrogenase , aspartate aminotransferase , as well as the score of APACHE II in the treatment group recovered more quickly than those in the control group ( P < 0.05 ) .
RESULTS	( 3 ) The occurrences of organic dysfunctions , local complications and mortality in both groups were not statistically different .
CONCLUSIONS	The short course administration of somatostatin continuously at early stage can reduce the inflammatory response , up-regulate the cell immune function and improve the conditions of the patients with SAP , but its effect on mortality and morbidity needs further study .

###21261786
BACKGROUND	The aim of the present study was to evaluate the effectiveness of zinc , probiotic bacteria , and lactose-free formula and their different combinations in the treatment of rotavirus diarrhea in young children .
METHODS	Eight different treatment groups were formed : group 1 , 60 patients receiving Saccharomyces boulardii ; group 2 , 60 patients receiving zinc ; group 3 , 60 patients receiving lactose-free formula ; group 4 , 60 patients receiving S. boulardii plus zinc ; group 5 , 60 patients receiving S. boulardii plus lactose-free formula ; group 6 , 60 patients receiving zinc plus lactose-free formula ; group 7 , 60 patients receiving S. boulardii plus zinc plus lactose-free formula ; group 8 , 60 patients receiving only oral and/or parenteral rehydration solutions .
RESULTS	No statistically significant differences were found in the time to resolution of fever after intervention between the treatment groups and the control group .
RESULTS	The time to resolution of vomiting was significantly lower in group 4 compared with groups 1 and 5 .
RESULTS	The duration of diarrhea was significantly reduced in groups 2 and 4 compared to control .
RESULTS	A statistically significant difference in the duration of hospitalization was observed for the groups 2 and 4 in comparison to the control group .
CONCLUSIONS	A different combination of adjunct therapies did not seem to bring additional value to rehydration therapy in children with rotavirus diarrhea except for in those receiving only zinc and zinc plus S. boulardii .
CONCLUSIONS	Further studies are required to determine the optimal protocol of adjunct therapy use in children with rotavirus diarrhea .

###8912962
OBJECTIVE	The authors compare the success of macular hole surgery with a short duration tamponade using 5 % perfluoropropane ( C3F8 ) , intermediate duration tamponade using 10 % C3F8 , or a long duration tamponade using 16 % C3F8 in a prospective consecutive clinical trial at two institutions .
METHODS	Vitrectomy and fluid-gas exchange was performed in 29 eyes treated with 5 % C3F8 and 1 week of prone positioning , 30 eyes treated with 10 % C3F8 and 2 weeks of prone positioning , and 90 eyes treated with 16 % C3F8 and 2 weeks of prone positioning 90 % of time , followed by 2 weeks of prone positioning 50 % of time .
RESULTS	The macular hole was closed successfully in 19 of 29 eyes ( 65.6 % ) treated with 5 % C3F8 , 19 of 30 eyes ( 63.3 % ) treated with 10 % C3F8 , and 85 of 90 eyes ( 94.4 % ) treated with 16 % C3F8 at 3 months ( P = 0.00017 for 5 % vs. 16 % C3F8 , P = 0.00006 for 10 % vs. 16 % C3F8 ) .
RESULTS	The visual acuity improvements measured by refraction using the Early Treatment Diabetic Retinopathy Study ( ETDRS ) acuity charts paralleled the success of macular hole closure .
RESULTS	The acuity improved a mean improvement of + 9.6 ETDRS letters for eyes treated with 5 % C3F8 , + 6.4 ETDRS letters for eyes treated with 10 % C3F8 , and + 13.1 ETDRS letters in eyes treated in 16 % C3F8 .
CONCLUSIONS	A long duration intraocular gas tamponade with 16 % C3F8 gives a substantially higher success rate for macular hole surgery than a short ( 5 % C3F8 ) or intermediate duration ( 10 % C3F8 ) intraocular gas tamponade .

###16698176
OBJECTIVE	To compare the efficacy and tolerability of propiverine and oxybutynin in patients with neurogenic detrusor overactivity .
METHODS	Patients were eligible , if at least 18 years of age and suffering from neurogenic detrusor overactivity .
METHODS	Eligibility also required a maximum cystometric capacity less than 300 ml .
METHODS	After a one-week run-in period , propiverine 15 mg t.i.d. or oxybutynin 5mg t.i.d. were administered for 21 days .
METHODS	As primary efficacy outcomes urodynamic parameters were assessed .
METHODS	As tolerability outcome the percentage of patients with newly manifesting anticholinergic adverse events was taken .
RESULTS	131 patients were recruited at 20 study centers .
RESULTS	The maximum cystometric capacity ( ml ) was increased significantly in the propiverine group from 198 ( + / -110 ) to 309 ( + / -166 ) , and in the oxybutynin group from 164 ( + / -64 ) to 298 ( + / -125 ) .
RESULTS	Similarly , maximum detrusor pressure during the filling phase ( cm H ( 2 ) O ) was lowered significantly in the propiverine group from 56.8 ( + / -36.2 ) to 37.8 ( + / -31.6 ) , and in the oxybutynin group from 68.6 ( + / -34.5 ) to 43.1 ( + / -29.2 ) .
RESULTS	No significant differences resulted between treatment groups .
RESULTS	Anticholinergic adverse events were reported less frequently in the propiverine compared to the oxybutynin group ( 63.0 % versus 77.8 % ) .
RESULTS	Dryness of the mouth , the most frequent adverse event , was reported significantly less ( 47.1 % versus 67.2 % ; p = 0.02 ) in the propiverine compared to the oxybutynin group .
CONCLUSIONS	Propiverine and oxybutynin are equally effective in increasing bladder capacity and lowering bladder pressure in patients with neurogenic detrusor overactivity .
CONCLUSIONS	The trend for better tolerability of propiverine compared to oxybutynin achieved significance for dryness of the mouth .

###9058627
OBJECTIVE	Short-chain fatty acids ( SCFAs ) derived from bacterial fermentation of complex carbohydrates are preferred luminal nutrients of the colonic mucosa .
OBJECTIVE	Starvation of colonocytes through lack or impaired metabolism of luminal SCFAs may be a cofactor in the pathogenesis of ulcerative colitis .
METHODS	A detailed histological evaluation of colonic biopsy specimens was performed in patients with active distal ulcerative colitis who were treated with rectal enemas containing a mixture of SCFAs , n-butyrate alone or saline placebo .
METHODS	Together with light microscopic parameters of mucosal inflammation , the pattern of crypt cell proliferation ( proliferating cell nuclear antigen ) and the mucosal activity of factor XIII were assessed .
RESULTS	Butyrate reduced the density of polymorphonuclear leucocytes in the lamina propria ( 4 weeks : P = 0.063 ; 8 weeks : P = 0.091 ) ; other inflammatory parameters remained unchanged .
RESULTS	Both butyrate and the SCFA mixture reduced significantly the number of proliferating cells in the upper 40 % of crypts .
RESULTS	Tissue factor XIII activity in active ulcerative colitis was significantly lower than in mucosa from normal colons ; however , it was not affected by SCFA or butyrate irrigation .
CONCLUSIONS	SCFAs and butyrate have a more marked effect on crypt cell proliferation than on parameters of inflammation in patients with active ulcerative colitis .

###10883872
OBJECTIVE	This clinical trial aimed at comparing 2 different means of delivering chlorhexidine digluconate ( CHX ) in the oral hygiene phase during the 2 weeks following periodontal surgery .
METHODS	40 patients were randomly divided into 2 groups : A ( using CHX mouthwash ) and B ( using CHX spray ) .
METHODS	Professional oral hygiene was carried out immediately before surgical operation .
METHODS	For 7 days after surgery , group A used CHX mouthwash and group B CHX spray on the teeth involved in the surgical procedure , while mechanical oral hygiene was maintained only on the teeth not involved surgically .
METHODS	After suture removal , on the 7th day , patients were allowed to perform mechanical oral hygiene also on surgical sites .
METHODS	Plaque index ( PI ) and stain index ( SI ) were evaluated on the 7th and 14th days after the operation .
RESULTS	In both groups , PI increased similarly with respect to the baseline in surgically involved teeth , being 0.25 + / -0.41 ( SD ) and 0.15 + / -0.26 , respectively , in A and B , on day 7 , and 0.14 + / -0.23 ( A ) and 0.10 + / -0.22 ( B ) , on day 14 .
RESULTS	There was no significant difference between A and B on either day 7 or 14 .
RESULTS	On the contrary , SI increased significantly in respect to the baseline over the 14 days in group A at both involved and not involved sites , while it did not differ from the baseline in group B.
CONCLUSIONS	The present results indicate that the efficacy of CHX spray in the post-surgical control of dental plaque is not different from that of CHX mouthwash .
CONCLUSIONS	Tooth staining , on the contrary , was significantly lower in the group using CHX spray .
CONCLUSIONS	The observed effects might be related to the way of delivering CHX and to the total dose administered , about 80 % lower in group B in respect to A. Further studies are needed to validate the preliminary findings of the present study .

###18543158
BACKGROUND	We conducted a prospective randomised trial to compare the postoperative results and complications following two postoperative treatment protocols ( dynamic motion vs. early active motion ) after transfer of the extensor indicis tendon .
METHODS	21 patients ( 10 female , 11 male ) were randomly assigned to two treatment protocols after transfer of the extensor indicis tendon .
METHODS	In one group of patients ( `` dynamic '' ) , the reconstructed tendon was extended passively with a rubber band system , in the other study group ( `` active '' ) , early active extension of the thumb was initiated .
METHODS	Active range of motion in the interphalangeal ( IP ) and metacarpophalangeal joints ( MP ) as well as grip and pinch strength were evaluated after the third , fourth , sixth and eighth postoperative week .
METHODS	All complications during the first postoperative year were noted .
METHODS	Statistical analysis was performed with chi-square and Mann-Whitney U-tests .
RESULTS	After the eighth postoperative week , in the IP joint an average range of motion of 69 degrees ( 45-110 degrees ) was found in the dynamic study group and 58 degrees ( 40-75 degrees ) in the active study group .
RESULTS	After three weeks , patients treated with the dynamic treatment protocol demonstrated significantly ( p = 0.03 ) greater ranges of motion , during the further treatment course no significant differences between the two groups were detected .
RESULTS	After eight weeks , the average grip and pinch strength was 66 % / 73 % of the contralateral side in the dynamic study group and 63 % / 71 % in the active study group .
CONCLUSIONS	With respect to the small groups of patients , both treatment protocols demonstrate comparable clinical results after 8 weeks .
CONCLUSIONS	Early active motion does not result in a higher rate of complications but fails to speed up rehabilitation .

###11110739
OBJECTIVE	To determine the acceptability of two psychological interventions for depressed adults in the community and their effect on caseness , symptoms , and subjective function .
METHODS	A pragmatic multicentre randomised controlled trial , stratified by centre .
METHODS	Nine urban and rural communities in Finland , Republic of Ireland , Norway , Spain , and the United Kingdom .
METHODS	452 participants aged 18 to 65 , identified through a community survey with depressive or adjustment disorders according to the international classification of diseases , 10th revision or Diagnostic and Statistical Manual of Mental Disorders , fourth edition .
METHODS	Six individual sessions of problem solving treatment ( n = 128 ) , eight group sessions of the course on prevention of depression ( n = 108 ) , and controls ( n = 189 ) .
METHODS	Completion rates for each intervention , diagnosis of depression , and depressive symptoms and subjective function .
RESULTS	63 % of participants assigned to problem solving and 44 % assigned to prevention of depression completed their intervention .
RESULTS	The proportion of problem solving participants depressed at six months was 17 % less than that for controls , giving a number needed to treat of 6 ; the mean difference in Beck depression inventory score was -2.63 ( 95 % confidence interval -4.95 to -0.32 ) , and there were significant improvements in SF-36 scores .
RESULTS	For depression prevention , the difference in proportions of depressed participants was 14 % ( number needed to treat of 7 ) ; the mean difference in Beck depression inventory score was -1.50 ( -4.16 to 1.17 ) , and there were significant improvements in SF-36 scores .
RESULTS	Such differences were not observed at 12 months .
RESULTS	Neither specific diagnosis nor treatment with antidepressants affected outcome .
CONCLUSIONS	When offered to adults with depressive disorders in the community , problem solving treatment was more acceptable than the course on prevention of depression .
CONCLUSIONS	Both interventions reduced caseness and improved subjective function .

###11216733
BACKGROUND	Spasm is a major concern with the use of arterial conduits in coronary artery bypass surgery ( CABG ) .
BACKGROUND	We evaluated the effect of systemic vasodilators on in vivo radial artery flow compared with internal mammary artery ( IMA ) flow .
METHODS	Fifty patients undergoing primary CABG with a mean age of 69 + / - 5 years enrolled in this study and were randomized to 1 of 5 groups based on the vasodilating agent administered ( nitroglycerin , nitroprusside , dobutamine , milrinone , and normal saline as control group ) .
METHODS	Radial artery and IMA flows , blood pressure , central venous pressure , and heart rate were measured before and 10 minutes after drug administration .
RESULTS	Mean arterial pressure decreased significantly after drug administration in both the nitroglycerin ( p = 0.007 ) and nitroprusside ( p < 0.001 ) groups and increased in the dobutamine group ( p < 0.001 ) .
RESULTS	There were no significant differences between IMA flow or radial flow among the groups before drug administration .
RESULTS	A multivariate general linear model was created and revealed drug ( specifically nitroglycerin ) as the only predictor to increase flow in the IMA ( p < 0.001 ) or the radial artery ( p = 0.009 ) .
CONCLUSIONS	We conclude that intravenous nitroglycerin causes in vivo vasodilatation of both the IMA and radial artery and is a good systemic vasodilator to be given when harvesting these two conduits .

###15781762
OBJECTIVE	To compare the effects of desloratadine , an H1-blocking antihistamine , and budesonide , an intranasal corticosteroid , on nasal peak inspiratory flow ( NPIF ) in patients with seasonal allergic rhinitis .
METHODS	We performed a randomized , double-blind , double-dummy , parallel study comparing oral desloratadine , 5 mg/d ( n = 31 ) , and budesonide , 32 mug/d per nostril ( n = 30 ) , for 2 weeks during the spring allergy season .
METHODS	Subjects recorded NPIF and nasal symptoms twice daily .
METHODS	Baseline measurements were obtained before initiation of treatment .
METHODS	The Rhinoconjunctivitis Quality of Life Questionnaire was completed at baseline and after treatment .
RESULTS	Desloratadine and budesonide caused a significant increase in NPIF compared with baseline on the evening of the first dose ( P < .01 ) .
RESULTS	Budesonide , however , led to a significantly greater increase in NPIF than did desloratadine when the change from baseline was compared for the entire treatment period ( median , 475 vs 150 L/min ; P = .01 ) .
RESULTS	Both treatments resulted in clinically significant reductions of the individual domains and overall scores on the Rhinoconjunctivitis Quality of Life Questionnaire ( P < .01 ) .
RESULTS	There was a significant reduction in total symptom scores ( P < or = .01 ) compared with baseline during all treatment days in both treatment groups , with no statistically significant differences between treatments ( median , -60.0 vs -59.5 ; P = .67 ) .
CONCLUSIONS	Both treatments led to significant improvements in NPIF , but the improvement was greater with the intranasal corticosteroid .
CONCLUSIONS	Both treatments improved quality of life and reduced symptoms .
CONCLUSIONS	The difference between the objective and subjective outcomes probably reflects the small sample size , the low pollen counts for the season , and the greater variability in subjective compared with objective measures .

###18580407
BACKGROUND	Few studies have reported the response of high-molecular-weight ( HMW ) adiponectin to acute aerobic exercise .
OBJECTIVE	The purpose of this study was to investigate the influence of acute aerobic exercise on HMW adiponectin in healthy men .
METHODS	Eight healthy men ( age , 24.9 + / - 1.8 yr ; BMI , 21.9 + / - 0.5 kg x m ) participated in this study .
METHODS	They performed two trials .
METHODS	Trial 1 [ exercise trial ( EX ) ] consisted of 60-min stationary cycle exercise ( 50 % peak oxygen uptake ) followed by 30-min rest .
METHODS	Trial 2 [ control trial ( CON ) ] was 90-min rest .
METHODS	Blood samples were drawn to assess hormones ( catecholamine and insulin ) , metabolites ( free fatty acid [ FFA ] , glycerol , and glucose ) , and total and HMW adiponectin concentration .
RESULTS	There were significant trial x group interactions in serum FFA and glycerol concentrations ( P < 0.05 ) .
RESULTS	Serum FFA and glycerol concentrations were higher in EX than in CON ( P < 0.05 ) .
RESULTS	There were significant trial x group interactions in plasma insulin and glucose concentration ( P < 0.05 ) .
RESULTS	Plasma insulin and glucose concentrations were lower in EX than in CON ( P < 0.05 ) .
RESULTS	Total adiponectin , HMW adiponectin concentration , and the ratio of HMW to total adiponectin concentration , however , were unchanged during aerobic exercise and postexercise .
RESULTS	Also , those changes did not differ between EX and CON .
CONCLUSIONS	Our results indicate that total adiponectin and HMW adiponectin concentrations are not regulated by the change of hormones or metabolites during acute moderate-intensity aerobic exercise and postexercise in healthy young men .

###11375232
OBJECTIVE	To investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface .
METHODS	Cluster randomised controlled trial .
METHODS	General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area .
METHODS	All 221 general practices in Glasgow ; 214 completed the trial .
METHODS	General practices in the intervention arm received clinical guidelines developed locally .
METHODS	Control practices received them one year later .
METHODS	Dissemination of the guidelines included educational meetings .
METHODS	The time from presentation to referral , investigations completed in general practice , the number and content of visits as a hospital outpatient , the time to reach a management plan , and costs for referrals from the two groups .
RESULTS	Data on 689 referrals were collected .
RESULTS	No significant difference was found in referral rates for infertility .
RESULTS	Fewer than 1 % of couples were referred inappropriately early .
RESULTS	Referrals from intervention practices were significantly more likely to have all relevant investigations carried out ( odds ratio 1.32 , 95 % confidence interval 1.00 to 1.75 , P = 0.025 ) .
RESULTS	70 % of measurements of serum progesterone concentrations during the midluteal phase and 34 % of semen analyses were repeated at least once in hospital , despite having been recorded as normal when checked in general practice .
RESULTS	No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan .
RESULTS	NHS costs were not significantly affected .
CONCLUSIONS	Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice , but there are no detectable differences in outcome for patients or reduction in costs .
CONCLUSIONS	Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors .
CONCLUSIONS	Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care .

###17413099
BACKGROUND	Resistance training ( RT ) and dietary protein independently influence indexes of whole-body glucose control , though their synergistic effects have not yet been documented .
OBJECTIVE	This study assessed the influence of dietary protein intake on RT-induced changes in systemic glucose tolerance and the contents of skeletal muscle insulin signaling proteins in healthy older persons .
METHODS	Thirty-six older men and women ( age : 61 + / - 1 y ) performed RT ( 3 times/wk for 12 wk ) and consumed either 0.9 g protein .
METHODS	kg ( -1 ) .
METHODS	d ( -1 ) [ lower-protein ( LP ) group ; approximately 112 % of the Recommended Dietary Allowance ( RDA ) ] or 1.2 g protein .
METHODS	kg ( -1 ) .
METHODS	d ( -1 ) [ higher-protein ( HP ) group ; approximately 150 % of the RDA ] ; the HP group consumed more total , egg , and dairy proteins .
RESULTS	After RT , body weight was unchanged ; whole-body protein and water masses increased , and fat mass decreased with no significantly different responses observed between the LP and HP groups .
RESULTS	The RT-induced improvement in oral glucose tolerance ( decreased area under the curve , AUC ) was not significantly different between the groups ( LP : -28 % ; HP : -25 % ) .
RESULTS	The insulin ( -21 % ) and C-peptide ( -14 % ) AUCs decreased in the LP group but did not change significantly in the HP group .
RESULTS	Skeletal muscle insulin receptor , insulin receptor substrate-1 , and Akt contents were unchanged , and the amount of atypical protein kinase C zeta/lambda ( aPKC zeta/lambda ) , a protein involved with insulin signaling , increased 56 % with RT , independent of protein intake .
CONCLUSIONS	These results support the hypothesis that older persons who consume adequate or moderately high amounts of dietary protein can use RT to improve body composition , oral glucose tolerance , and skeletal muscle aPKC zeta/lambda content without a change in body weight .

###8409874
BACKGROUND	As physicians begin to use computer technology in front of patients during clinical encounters , concern has been raised that such computer use may exert a dehumanizing effect on the physician-patient relationship .
BACKGROUND	To investigate this concern , we measured patient reactions to physician use of a computerized medical record system during clinical encounters .
METHODS	Adult patients who presented for clinical care were randomized into three groups .
METHODS	With the first group , the physician used a standard paper-and-pencil charting system during the encounter .
METHODS	With the second group , the physician used a computerized medical record system with keyboard input .
METHODS	With the third group , the physician used the computerized medical record system with voice input .
METHODS	Patient reactions were measured with a questionnaire that the patients completed after the clinical encounter .
RESULTS	For most components of the physician-patient relationship studied in this report , questionnaire scores did not differ significantly among the three study groups .
RESULTS	Patients in the voice input group rated physician explanations of patient problems significantly higher than patients in the other two groups .
RESULTS	There was a trend for patient confidence in the physician to be higher in the keyboard input group .
RESULTS	Although measured encounter durations were significantly shorter in the computer groups , there were no differences in patient satisfaction with encounter duration among the three groups .
CONCLUSIONS	Physician use of computers during clinical encounters was not associated with a decline in the perceived quality of the physician-patient relationship .

###17306507
BACKGROUND	Overweight and obesity are common concerns in individuals with severe mental disorders .
BACKGROUND	In particular , antipsychotic drugs ( AP ) frequently induce weight gain .
BACKGROUND	This phenomenon lacks current management and no previous controlled studies seem to use cognitive therapy to modify eating and weight-related cognitions .
BACKGROUND	Moreover , none of these studies considered binge eating or eating and weight-related cognitions as possible outcomes .
OBJECTIVE	The main aim of this study is to assess the effectivity of cognitive and behavioural treatment ( CBT ) on eating and weight-related cognitions , binge eating symptomatology and weight loss in patients who reported weight gain during AP treatment .
METHODS	A randomized controlled study ( 12-week CBT vs. Brief Nutritional Education ) was carried out on 61 patients treated with an antipsychotic drug who reported weight gain following treatment .
METHODS	Binge eating symptomatology , eating and weight-related cognitions , as well as weight and body mass index were assessed before treatment , at 12 weeks and at 24 weeks .
RESULTS	The CBT group showed some improvement with respect to binge eating symptomatology and weight-related cognitions , whereas the control group did not .
RESULTS	Weight loss occurred more progressively and was greater in the CBT group at 24 weeks .
CONCLUSIONS	The proposed CBT treatment is particularly interesting for patients suffering from weight gain associated with antipsychotic treatment .

###21193281
OBJECTIVE	When comparing the efficacy of different interventions for cancer patients , there should be certainty that these types are sufficiently different in the way they are actually presented .
OBJECTIVE	The aim of the present study is to develop a method for assessing differences between the content of social support groups and experiential-existential therapy groups .
METHODS	Independent and blind raters assessed video fragments of both intervention types , using a self-developed checklist of five questions .
METHODS	This checklist was first evaluated by a group of experts for appropriateness , importance , and rateability .
RESULTS	Three out of the five questions were selected on the basis of these experts ' evaluation and on inter-rater reliability .
RESULTS	The scores on these questions were used to evaluate five social support groups and six experiential-existential therapy groups for breast cancer patients .
RESULTS	According to the independent and blind raters the content of the two intervention forms appeared to be significantly different .
CONCLUSIONS	The assessment method we developed appeared reliable and valid .
CONCLUSIONS	Our assessment method is feasible as a check to compare the content of psycho-oncological interventions and can be easily adjusted into a test for other intervention types .

###11481357
OBJECTIVE	To investigate the effect of adding tamoxifen to a preoperative dose-dense doxorubicin and docetaxel regimen on the pathologic response of primary operable breast cancer .
METHODS	Patients ( tumor size > or = 3 cm , N0 to 2 , M0 ) were prospectively randomized to receive every 14 days a total of four cycles of doxorubicin 50 mg/m2 and docetaxel 75 mg/m ( 2 ) , either with ( ADocT ) or without ( ADoc ) simultaneous tamoxifen .
METHODS	Granulocyte colony-stimulating factor ( G-CSF ) was routinely given on days 5 to 10 .
METHODS	Surgery followed 8 to 10 weeks after the start of treatment .
RESULTS	Within 14 months , 250 patients were included in the study at 56 centers .
RESULTS	Of 992 planned cycles , 97.9 % were administered .
RESULTS	Pathologically complete remission ( pCR ) with no detectable viable tumor cells was achieved in 9.7 % .
RESULTS	There was a nonsignificant difference of -1.2 % in favor of ADoc , with a 95 % confidence interval of -8.6 % to 6.2 % .
RESULTS	A further 2.4 % had only noninvasive tumor residues , and 13.8 % had focal invasive residues .
RESULTS	Complete and partial responses detected by palpation were observed in 28.9 % and 52.4 % , respectively .
RESULTS	The response rates ( complete and partial ) by best appropriate imaging methods were 77.5 % and 67.5 % for ADocT and ADoc , respectively .
RESULTS	Breast conservation was possible in 68.8 % of the patients .
RESULTS	A tendency toward more frequent toxic events was observed with ADocT treatment .
RESULTS	Significant predictors of pCR to chemotherapy were negative lymph node and negative estrogen receptor status .
CONCLUSIONS	A dose-dense regimen of ADoc with G-CSF offers high compliance , moderate toxicity , and rapid efficacy as a form of preoperative chemotherapy in operable breast cancer .
CONCLUSIONS	Concurrent treatment with tamoxifen for 8 weeks could not improve the pathologic response rate .

###18265662
OBJECTIVE	Standard interferon or lamivudine monotherapy has been shown to induce a low response rate in patients with chronic hepatitis B infection .
OBJECTIVE	Genotype D represents almost the whole of chronic HBV infection of Turkish population .
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of the long-term interferon-alpha plus lamivudine on these patients , and thereafter the co-effect of maintenance therapy by lamivudine .
METHODS	This prospective study was carried out between the late 1999 and 2005 .
METHODS	A total of 37 ( 24 HBeAg-positive and 13 HBeAg-negative ) patients were enrolled in the study .
METHODS	These patients received standard interferon-alpha ( 9/10 MU ) three times sc .
METHODS	a week plus lamivudine 100mg po .
METHODS	daily , for 52 weeks .
METHODS	After the interferon discontinuation , lamivudine monotherapy was assigned to be given until 4-6 months after the occurrence of HBeAg seroconversion in the HBeAg-positive patients and at least three years in HBeAg-negative patients .
METHODS	Response-1 was defined as the response at the end of combination therapy at the 52nd week , and Response-2 as response at the end of the follow-up period under lamivudine monotherapy .
METHODS	An intention-to-treat analysis was performed .
RESULTS	Patients ' follow-up ranged between 7-67 months , with a mean duration of 29.64 + / - 14.01 months .
RESULTS	Twenty-six patients ( 70.3 % ) had a Response-1 , both virological and biochemical .
RESULTS	A biochemical Response-2 was achieved in 24 patients ( 64.9 % ) , while virological Response-2 in 17 ( 45.9 % ) .
RESULTS	Response-1 and Response-2 were similar between HBeAg-positive and HBeAg-negative patients ( p = 0.262 and p = 0.734 , respectively ) .
RESULTS	HBeAg seroconversion was achieved only in 8 ( 33.3 % ) of HBeAg-positive patients .
RESULTS	Clinical resistance to lamivudine developed only in 9 ( 24.3 % ) of the patients .
RESULTS	Decompensation or hepatocellular carcinoma did not observe in any case .
CONCLUSIONS	This study showed the efficacy of the ` long-term ' anti-viral maintenance along with the combination therapy in genotype D predominant chronic hepatitis B patients .
CONCLUSIONS	A low clinical resistance rate to lamivudine was achieved .

###21365629
BACKGROUND	Lonafarnib ( LNF ) is a protein farnesyl transferase ( FTase ) inhibitor that has shown synergistic activity with taxanes in preclinical models and early stage clinical trials .
BACKGROUND	Preclinical findings suggested tubulin acetylation and FTase expression levels may be important determinants of drug sensitivity that would help identify patient populations more likely to benefit from this regimen .
BACKGROUND	This pilot study evaluated the biological effects of LNF and docetaxel ( DTX ) combination therapy in refractory solid tumors by comparing pretreatment and post-treatment tumor biopsies .
METHODS	Patients with histologically confirmed locally advanced or metastatic solid malignancies refractory to standard therapies or with no effective therapies available were eligible .
METHODS	Patients were randomized to 1 of 4 dosing cohorts : 1 ) 30 mg/m , 100 mg ; 2 ) 36 mg/m , 100 mg ; 3 ) 30 mg/m , 150 mg ; or 4 ) 36 mg/m , 150 mg of DTX intravenously weekly , LNF orally twice daily , respectively .
RESULTS	Of the 38 patients enrolled , 36 were treated , and 29 were evaluable for toxicity and response assessment .
RESULTS	The combination of LNF and DTX was tolerated in all cohorts with the exception of a 28 % incidence of grade 3/4 diarrhea , which was manageable with aggressive antidiarrheal regimens .
RESULTS	Seven patients derived clinically meaningful benefit from this combination treatment ; these patients had significantly lower basal FTase-beta mRNA expression levels than the mean study population level ( P < .05 ) .
RESULTS	Correlation of clinical benefit with tubulin acetylation content as well as basal acetyl-tubulin content were evaluated .
RESULTS	However , no significant correlation was found .
CONCLUSIONS	Despite the small number of patients , these findings support our preclinical mechanistic studies and warrant further clinical investigations using FTase-beta mRNA expression as a potential predictive biomarker to select for an enriched patient population to study the effects of taxane and FTase inhibitor combination therapies .

###22607546
BACKGROUND	A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes , thus a single treatment approach is seldom efficient .
BACKGROUND	The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain .
BACKGROUND	The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values .
BACKGROUND	Our main hypothesis is that the tailored treatment has better short , intermediate and long-term effects than either non-tailored treatment or treatment-as-usual ( TAU ) on pain and function .
BACKGROUND	We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU .
METHODS	120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20-65 , are allocated by minimisation with the factors age , duration of pain , pain intensity and disability in to the groups tailored treatment ( T ) , non-tailored treatment ( NT ) or treatment-as-usual ( TAU ) .
METHODS	Treatment is given to the groups T and NT for 11 weeks ( 27 sessions evenly distributed ) .
METHODS	An extensive presentation of the tests and treatment decision model is provided .
METHODS	The main treatment components are manual therapy , cranio-cervical flexion exercise and strength training , EMG-biofeedback training , treatment for cervicogenic headache , neck motor control training .
METHODS	A decision algorithm based on the baseline assessment determines the treatment components given to each participant of T - and NT-groups .
METHODS	Primary outcome measures are physical functioning ( Neck Disability Index ) and average pain intensity last week ( Numeric Rating Scale ) .
METHODS	Secondary outcomes are general improvement ( Patient Global Impression of Change scale ) , symptoms ( Profile Fitness Mapping neck questionnaire ) , capacity to work in the last 6 weeks ( quality and quantity ) and pressure pain threshold of m. trapezius .
METHODS	Primary and secondary outcomes will be reported for each group with effect size and its precision .
CONCLUSIONS	We have chosen not to include women with psychological ill-health and focus on biomedical aspects of neck pain .
CONCLUSIONS	Future studies should aim at including psychosocial aspects in a widened treatment decision model .
CONCLUSIONS	No important adverse events or side-effects are expected .

###23622912
BACKGROUND	Only limited and conflicting data on the impact of preoperative chronic kidney disease ( CKD ) on outcomes after transcatheter aortic valve implantation ( TAVI ) are available .
METHODS	We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers ( 942 patients ) .
METHODS	Valve Academic Research Consortium end point definitions were used .
METHODS	The outcomes were compared among patients with normal estimated glomerular filtration rate ( 90 mL/min ) , mild ( 60-89 mL/min ) , moderate ( 30-59 mL/min ) , and severe ( < 30 mL/min ) CKD and those on chronic hemodialysis ( HD ) .
METHODS	The primary end point was 1-year survival .
RESULTS	A total of 109 patients had a normal estimated glomerular filtration rate ( 11.6 % ) ; 329 ( 34.9 % ) had mild , 399 ( 42.5 % ) moderate , 72 ( 7.5 % ) severe CKD , and 33 ( 3.5 % ) were on HD .
RESULTS	Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE .
RESULTS	Major stroke , life-threatening bleeding , all-cause 30-day mortality ( HD 15.2 % , severe CKD 8.3 % , moderate CKD 8.3 % , mild CKD 6.7 % , normal 1.8 % , P = .007 ) and 1-year survival ( HD 54.8 % , severe CKD 67.2 % , moderate CKD 80.0 % , mild CKD 85.2 % , normal eGFR 91.4 % , HD vs severe CKD P = .23 , severe CKD vs moderate CKD P = .002 , moderate CKD vs mild CKD P = .04 , moderate CKD vs normal eGFR P = .03 , by log-rank test ) differed significantly across groups .
RESULTS	Through multivariable analysis , HD and severe CKD were independently associated with an increased risk of 1-year mortality ( hazard ratios 5.07 [ 95 % CI 1.79-14 .35 , P = .002 ] and 4.03 [ 95 % CI 1.52-10 .69 , P = .005 ] , respectively ) .
CONCLUSIONS	Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes .
CONCLUSIONS	Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI .

###17216681
OBJECTIVE	To examine the prevalence of depressive symptoms in a cross-sectional study of postmenopausal women with osteoporosis with and without prevalent vertebral fracture .
METHODS	Participants were a subset of English-speaking women ( n = 3798 , mean age 66.7 yrs ) from the Multiple Outcomes of Raloxifene Evaluation trial , who had low bone mineral density ( BMD ) and/or prevalent vertebral fractures .
METHODS	Vertebral fractures were measured at baseline by radiography using a semiquantitative technique .
METHODS	Depressive symptoms were assessed at baseline using the Geriatric Depression Scale ( GDS ) , a valid and reliable scale for depression screening in elderly patients .
METHODS	Women were considered as probably depressed if > or = 6 symptoms of depression were reported .
RESULTS	Postmenopausal women with prevalent vertebral fracture reported more depressive symptoms as assessed by the GDS than women without prevalent vertebral fracture ( 1.54 vs 1.26 ; p = 0.001 ) .
RESULTS	There was an absolute increase of 2.5 % ( p = 0.008 ) in the prevalence of probable depression ( GDS score > or = 6 ) in women with prevalent fracture compared to those without prevalent fracture .
RESULTS	The prevalence of probable depression was 4.1 % among women without prevalent vertebral fracture and 6.6 % in women with a prevalent vertebral fracture .
RESULTS	The prevalence of probable depression was 3-fold higher in women with at least 3 prevalent vertebral fractures compared to women without prevalent fracture ( 12.8 % vs 4.1 % ; p < 0.001 ) .
CONCLUSIONS	Postmenopausal women with prevalent vertebral fractures had greater prevalence of depressive symptoms and probable depression as assessed by the GDS than women without vertebral fracture with low BMD .
CONCLUSIONS	The dual diagnosis of depression and osteoporosis may mean worse health outcomes .
CONCLUSIONS	Patients with prevalent vertebral fractures may be considered not only for interventions that address fracture risk reduction , but also for psychosocial interventions that address depressive symptoms .

###21040375
OBJECTIVE	To compare racemic ketamine and S-ketamine as induction agents prior to isoflurane anaesthesia .
METHODS	Prospective , blinded , randomized experimental study .
METHODS	Thirty-one healthy adult goats weighing 39-86 kg .
METHODS	Goats were premedicated with xylazine ( 0.1 mg kg ( -1 ) ) intravenously ( IV ) given over 5 minutes .
METHODS	Each goat was assigned randomly to one of two treatments for IV anaesthetic induction : group RK ( 15 goats ) racemic ketamine ( 3 mg kg ( -1 ) ) and group SK ( 16 goats ) S-ketamine ( 1.5 mg kg ( -1 ) ) .
METHODS	Time from end-injection to recumbency was measured and quality of anaesthetic induction and condition for endotracheal intubation were scored .
METHODS	Anaesthesia was maintained with isoflurane in oxygen for 90 minutes .
METHODS	Heart rate , invasive arterial blood pressure , oxygen saturation , temperature , end-tidal carbon dioxide and isoflurane were recorded every 5 minutes .
METHODS	Arterial blood samples were taken for analysis every 30 minutes .
METHODS	Recovery time to recurrence of swallowing reflex , to first head movement and to standing were recorded and recovery quality was scored .
METHODS	Two-way repeated measures anova , Mann-Whitney and a Mantel-Cox tests were used for statistical analysis as relevant with a significance level set at p < 0.05 .
RESULTS	Induction of anaesthesia was smooth and uneventful in all goats .
RESULTS	There was no statistical difference between groups in any measured parameter .
RESULTS	Side effects following anaesthetic induction included slight head or limb twitching , moving forward and backward , salivation and nystagmus but were minimal .
RESULTS	Endotracheal intubation was achieved in all goats at first or second attempt .
RESULTS	Recovery was uneventful on all occasions .
RESULTS	All goats were quiet and needed only one or two attempts to stand .
CONCLUSIONS	S-ketamine at half the dose rate of racemic ketamine in goats sedated with xylazine and thereafter anaesthetised with isoflurane induces the same clinically measurable effects .

###15822580
OBJECTIVE	To determine the effect of morphine administered prior to anesthesia on the incidence of gastroesophageal reflux ( GER ) in dogs during the subsequent anesthetic episode .
METHODS	90 dogs ( 30 dogs/group ) .
METHODS	The randomized prospective clinical study included healthy dogs with no history of vomiting .
METHODS	Dogs were scheduled to undergo elective orthopedic surgery .
METHODS	Food was withheld for ( mean + / - SD ) 17.8 + / -4.1 hours prior to induction of anesthesia .
METHODS	The anesthetic protocol included acepromazine maleate , thiopental , and isoflurane .
METHODS	Dogs were randomly selected to receive morphine at various dosages ( 0 , 0.22 , or 1.10 mg/kg , IM ) concurrent with acepromazine administration prior to induction of anesthesia .
METHODS	A sensor-tipped catheter was used to measure esophageal pH , and GER was defined as a decrease in pH to < 4 or an increase to > 7.5 .
RESULTS	40 dogs had acidic reflux , and 1 had biliary reflux .
RESULTS	Proportions of dogs with GER were 8 of 30 ( 27 % ) , 15 of 30 ( 50 % ) , and 18 of 30 ( 60 % ) for morphine dosages of 0 , 0.22 , and 1.10 mg/kg , respectively .
RESULTS	Mean duration of GER was 91.4 + / -56.8 minutes .
RESULTS	There was no significant association between GER and age , weight , vomiting after preanesthetic medication , administration of antimicrobials , or start of surgery .
CONCLUSIONS	Most healthy dogs vomit after a large dose of morphine , but vomiting does not increase the likelihood of GER during the subsequent anesthetic episode .
CONCLUSIONS	Administration of morphine prior to anesthesia substantially increases the incidence of GER during the subsequent anesthetic episode .

###21189774
OBJECTIVE	The objective of this study was to comparatively evaluate the effectiveness ofsubmucosalfentanyl when administered in conjunction with oral midazolam during pediatric procedural sedations .
METHODS	Twenty three uncooperative ASA type I children who met the selection criteria were randomly assigned to receive either submucosal fentanyl ( 3 microg/kg ) or placebo , along with oral midazolam ( 0.5 mg/kg ) .
METHODS	A triple blind , 2-stage cross-over design was adopted so that each child received both the regimens .
RESULTS	Transient oxygen desaturation was observed in 4 children who were sedated with the combination of oral midazolam and submucosalfentanyl .
RESULTS	The overall success was 73.91 % with oral midazolam and submucosal fentanyl regimen and 47.83 % for oral midazolam and submucosal placebo regimen .
RESULTS	The chances of ` satisfactorily ` completing a 45 minute dental procedure in an uncooperative pediatric patient was 2.8 times more , when submucosalfentanyl was used along with oral midazolam .
CONCLUSIONS	Submucosal fentanyl appears to improve the short working time associated with oral midazolam .
CONCLUSIONS	But the oxygen desaturation associated with this regimen necessitates further studies to evaluate the efficacy of this combination at relatively lower doses before being used routinely for pediatric procedural sedation and analgesia .

###9236443
BACKGROUND	Pacemakers and theophylline are currently being used to relieve symptoms in patients with sick sinus syndrome ( SSS ) .
BACKGROUND	However , the impact of either therapy on the natural course of the disease is unknown .
BACKGROUND	We conducted a randomized controlled trial to prospectively assess the effects of pacemakers and theophylline in patients with SSS .
RESULTS	One hundred seven patients with symptomatic SSS ( age , 73 + / - 11 years ) were randomized to no treatment ( control group , n = 35 ) , oral theophylline ( n = 36 ) , or dual-chamber rate-responsive pacemaker therapy ( n = 36 ) .
RESULTS	They were followed for up to 48 months ( mean , 19 + / - 14 months ) .
RESULTS	During follow-up , the occurrence of syncope was lower in the pacemaker group than in the control group ( P = .02 ) and tended to be lower than in the theophylline group ( P = .07 ) .
RESULTS	Heart failure occurred less often in patients assigned to pacemaker therapy and theophylline than in control patients ( both , P = .05 ) , whereas the incidence of sustained paroxysmal tachyarrhythmias , permanent atrial fibrillation , and thromboembolic events did not show any apparent difference among the three groups .
RESULTS	Heart rate was higher in the theophylline group than in the control group .
RESULTS	Both pacemaker therapy and theophylline improved symptom scores after 3 months of treatment ; however , a similar improvement was observed in the control group .
CONCLUSIONS	In patients with symptomatic SSS , therapy with theophylline or dual-chamber pacemaker is associated with a lower incidence of heart failure ; pacemaker therapy is also associated with a lower incidence of syncope .
CONCLUSIONS	The therapeutic benefits of pacemakers and theophylline on symptoms are partly a result of spontaneous improvement of the disease .

###22410021
OBJECTIVE	Ischemic reperfusion ( IR ) injury is known to have an important influence on the success of transplant surgery and the occurrence of complications .
OBJECTIVE	Malondialdehyde ( MDA ) is an intermediate metabolite of lipid peroxidation resulting from IR-induced reactive oxygen species .
OBJECTIVE	This study was designed to investigate the protective effects of propofol on IR injury in liver transplant recipients .
METHODS	We analyzed 19 recipients prospectively by measuring the blood levels of MDA at nine predefined intervals ; before induction of anesthesia ( baseline , T0 ) , 1 hour after surgical incision ( T1 ) , 1 minute before reperfusion ( T2 ) , 30 seconds after reperfusion ( T3 ) , as well as 1 , 3 , 5 , 30 , and 60 minutes thereafter ( T4-8 ) .
METHODS	These patients were randomly allocated to two groups .
METHODS	The propofol group received an infusion ( 2 mg/kg per hr ) after an induction bolus ( 2 mg/kg ) .
METHODS	The control group was prescribed midazolam ( 0.2 mg/kg ) for induction without intravenous anesthetic infusion for maintenance .
RESULTS	The highest MDA level occured at T6 in the controls and T7 in the propofol group .
RESULTS	Compared with the blood levels at baseline , the MDA levels increased significantly at T2-T8 among controls versus T2 , T3 , T4 , and T7 in the propofol group .
RESULTS	Compared to the control group , propofol significantly lowered MDA values at T5-T8 .
CONCLUSIONS	There were significantly higher MDA levels among the control versus the propofol group at 3 , 5 , 30 , and 60 minutes after reperfusion in liver transplant recipients .

###25960303
BACKGROUND	Evidence of a beneficial effect of exercise training on mediators of vascular disease is accumulating in chronic kidney disease ( CKD ) , but its effect on vascular function in vivo still has to be established .
BACKGROUND	The present study was designed to investigate whether a formal aerobic exercise training program improves peripheral endothelial function in patients with CKD stages 3 to 4 .
METHODS	Randomized controlled trial with a parallel-group design .
METHODS	48 patients with CKD stages 3 to 4 without established cardiovascular disease were randomly assigned to either an exercise training program or usual care .
METHODS	40 patients completed the study ( exercise training , 19 ; usual care , 21 ) .
METHODS	The 3-month home-based aerobic training program consisted of 4 daily cycling sessions of 10 minutes each at a target heart rate , calculated as 90 % of the heart rate achieved at the anaerobic threshold .
METHODS	Patients in the usual-care group were given standard therapy .
RESULTS	The primary outcome was peripheral endothelial function .
RESULTS	Secondary outcomes were aerobic capacity , arterial stiffness , numbers of endothelial ( EPCs ) and osteogenic progenitor cells ( OPCs ) , migratory function of circulatory angiogenic cells , and health-related quality of life .
METHODS	Endothelial function was assessed with flow-mediated dilation of the brachial artery , aerobic capacity by peak oxygen uptake ( VO ( 2peak ) ) , arterial stiffness by carotid-femoral pulse wave velocity , numbers of EPCs and OPCs by flow cytometry , circulatory angiogenic cell function by an in vitro migratory assay , and quality of life by the Kidney Disease Quality of Life-Short Form questionnaire .
RESULTS	Exercise training significantly improved VO ( 2peak ) and quality of life , but not in vivo vascular function ( flow-mediated dilation and carotid-femoral pulse wave velocity ) or cellular markers for vascular function ( EPC and OPC count and circulatory angiogenic cell migratory function ) .
CONCLUSIONS	Short duration and intermittent nature of the exercise intervention .
CONCLUSIONS	In patients with CKD stages 3 to 4 without overt cardiovascular disease , 3 months of aerobic exercise training improved VO ( 2peak ) and quality of life , without altering endothelial function or arterial stiffness .

###15136383
OBJECTIVE	To assess the effects of tiotropium on lung mucociliary clearance in COPD .
METHODS	Randomized , double-blind , placebo-controlled , parallel-group study .
METHODS	Outpatients of an urban-area university teaching hospital .
METHODS	Thirty-four patients with COPD aged 40 to 75 years classified equally into two groups .
METHODS	Single ( 18 microg ) daily dose of tiotropium inhalation capsules or of placebo for 21 days .
METHODS	Six-hour tracheobronchial clearance of inhaled 99mTc-labeled polystyrene particles using a 48-h retention measurement to determine the `` nontracheobronchial '' deposition fraction .
RESULTS	Test radioaerosol penetration into the lungs increased significantly ( p < 0.003 ) as did FEV1 ( p < 0.006 ) in the tiotropium-treated patients , but measured mucociliary clearance was not significantly changed despite the increased pathway length for clearance ( mean + / - SE area under the tracheobronchial retention curve changed from 442 + / - 22 to 453 + / - 20 % / h ) .
RESULTS	Smaller ( nonsignificant ) decreases of radioaerosol penetration and FEV1 occurred in the placebo group together with a small ( nonsignificant ) decrease in the area under the retention curve .
CONCLUSIONS	Twenty-one days of inhaled tiotropium , 18 microg/d , as a dry powder does not retard mucus clearance from the lungs .

###16320677
OBJECTIVE	To compare efficacy of 3-oxypiridine and succinic acid derivatives ( emoxipine , reamberine and mexidol ) in distal neuropathy ( DN ) and left ventricular myocardium systolic function ( LVMSF ) in diabetic patients with diabetic foot syndrome ( DFS ) .
METHODS	We studied 120 patients with diabetes mellitus type 1 and 2 ( DM1 and DM2 ) .
METHODS	The patients had neuropathic and neuroischemic forms of DFS ( stage 0-1 by Wagner , 1990 ) .
METHODS	The patients were randomized into 4 equal groups matched by gender and number of patients with DM1 and DM2 .
METHODS	Group 1 received basic therapy plus intravenous placebo ( daily 200 ml drops of the polarizing mixture ) .
METHODS	Group 2 received additional 150 mg emoxipine .
METHODS	Group 3 was given daily intravenous drop infusions of 400 ml reamberin .
METHODS	Group 4 received once daily 300 mg mexidol .
METHODS	The infusion therapy in all the groups lasted for 14 days .
METHODS	Quantitation of neuropathic symptomatic count ( NSC ) , neuropathic dysfunction count ( NDC ) and echocardiographic examination of LVMSF were made and venous blood samples were obtained before the treatment and after 2 weeks of therapy .
RESULTS	Emoxipin , reamberin and mexidol therapy alleviated DM symptoms .
RESULTS	In contrast to placebo , the drugs lessened the scores by NSC and NDC .
RESULTS	By NSC , the lowest total score was observed after treatment with reamberin .
RESULTS	LVMSF changed most significantly in patients on emoxipin , less significantly in those on reamberin and insignificantly on mexidol .
RESULTS	The above positive effect did not depend on metabolic compensation of DM .
CONCLUSIONS	The addition of emoxipin , reamberin and mexidol to the scheme of DM patients with DFS relieves symptoms of DM .
CONCLUSIONS	Moreover , reduction of DM symptoms due to emoxipin and reamberin is associated with better LVMSF .

###8617693
BACKGROUND	Patterns of response to the light box and head-mounted unit ( HMUs ) in seasonal affective disorder ( SAD ) appear to differ .
BACKGROUND	The current study employed a `` no light '' condition to compare the response rates with the light box and HMU against a plausible placebo .
METHODS	Forty-three subjects with DSM-III-R nonpsychotic , unipolar major depression , seasonal subtype , were randomly assigned , in a double-blind manner , to receive 2 weeks of active treatment with a light box ( N = 9 ) or HMU ( N = 12 ) that emitted no visible light , or 2 weeks of placebo treatment with a light box ( N = 12 ) or HMU ( N = 10 ) that emitted no visible light .
METHODS	Response was defined as a 50 % or greater reduction in both the 17-item `` typical '' score and 8-item `` atypical '' score on the Structured Interview Guide for the Hamilton Rating Scale for Depression-SAD version ( SIGH-SAD ) .
RESULTS	Using ANOVA for repeated measures , with change in total SIGH-SAD score as the dependent measure , we found no significant main effect of light ( F = 0.20 , p = N.S. ) or unit ( F = 0.50 , p = N.S. ) , and no interaction ( F = 0.21 , p = N.S. ) .
RESULTS	Using log-linear analysis , we found no significant difference in response rate between the four cells ( likelihood ratio chi-square = 2.1 , p = N.S. ) .
RESULTS	Using chi-square analysis , we found no significant difference in response rates between patients who received light ( 48 % ) versus patients who received no light ( 41 % ; chi-square = 0.2 , p = N.S. ) or between patients who received the light box ( 38 % ) versus HMU ( 50 % ; chi-square = 0.62 , p = N.S. ) .
CONCLUSIONS	The failure to detect any significant difference in efficacy between active and placebo treatments calls into question the specificity of light in light therapy for SAD .
CONCLUSIONS	Methodological limitations , particularly small sample size , are discussed .

###20861405
BACKGROUND	The rate of non-compliance with vitamin D supplementation is as high as 45 % .
BACKGROUND	This is why randomised controlled trials are needed to analyse the response to low doses of vitamin D3 .
OBJECTIVE	( 1 ) To compare supplementation with 250 versus 500 units of vitamin D3 and ( 2 ) to analyse sun exposure time/ultraviolet B ( UVB ) exposure during the first 6 weeks of life .
METHODS	40 breastfed infants ( skin photo-types I , II ) were recruited in Berlin , Germany ( 52.5 N ) , during summer ( n = 20 ) and winter ( n = 20 ) and randomised into equal groups on either 250 or 500 units of vitamin D3 per day .
METHODS	Outcome measures were : parameters of vitamin D and bone metabolism at delivery and 6 weeks later , sun exposure time , UVB dosimetry and surrounding factors including maternal diet .
RESULTS	At delivery 25-hydroxy vitamin D levels were insufficient : 68 ( 53-83 ) nmol/l in each group .
RESULTS	6 weeks later levels were sufficient : 139 ( 114-164 ) nmol/l on 250 units of vitamin D3 per day and 151 ( 126-176 ) nmol/l on 500 units/day .
RESULTS	There was no seasonal variation .
RESULTS	Daily sun exposure time was 0.4-3 .5 h and higher in summer .
RESULTS	UVB exposure was 0.01-0 .08 minimal erythema dose/day .
RESULTS	Calcium levels were within normal .
CONCLUSIONS	In Berlin , Germany , supplementation with 250 units of vitamin D3 is sufficient for breastfed infants during their first 6 weeks of life in summer and winter .
CONCLUSIONS	UVB exposure is very low throughout the year .

###11598535
OBJECTIVE	The objective of the study was to estimate the cost of first line chemotherapy in metastatic colorectal cancer treated in the Gustave-Roussy Institute .
OBJECTIVE	Patients were randomized in the study FFCD 9601 with four schedules of treatment : Tomudex ( R ) , 5FU weekly , LV5FU2 with low dose of folinic acid and LV5FU2 with high dose of folinic acid .
METHODS	Thirty three patients were included prospectively from March 1997 to April 1999 .
METHODS	Healthcare costs took into account drug-regimen related costs ( cost of the drugs and its preparation , drug administration , laboratory tests , transport from and to hospital ) , non-drug-regimen related hospitalization costs ( treatment of chemotherapy related side effects , radiologic tests , hospital outpatient visits , transport from and to hospital ) and surgery costs .
METHODS	Costs were derived from the accounting system in the Gustave-Roussy Institute .
METHODS	Non medical costs were not taken into account in this study .
RESULTS	The median overall cost per 4 weeks was 6,343 FF with LV5FU2 low dose , 9,968 FF with LV5FU2 high dose , 15,340 FF with 5FU weekly and 28,810 FF with Tomudex ( R ) .
RESULTS	This overcost is explained by a more expensive price and greater toxicity : 12 grade 3-4 toxicity and 9 hospitalizations ( including one in intensive care unit for the 8 treated patients ) for Tomudex ( R ) despite a lower cost for the administration of the drug .
RESULTS	Weekly 5FU was the most expensive among the 5FU schedules because of its dose and frequency of administration .
CONCLUSIONS	The cost of first line chemotherapy in metastatic cancer colorectal is high ( 6,000 FF minimum per 4 weeks of treatment ) .
CONCLUSIONS	Tomudex , a recent and expensive drug , seems to be more toxic .
CONCLUSIONS	In this study , toxicity was probably overestimated due to the small number of patients .
CONCLUSIONS	More patients are necessary in order to better estimate the cost of toxicity of these chemotherapies .

###21407218
BACKGROUND	An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting .
BACKGROUND	Re-exposure in the metastatic stage is limited by drug resistance , thus evaluation of non-cross-resistant regimens is mandatory .
METHODS	Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens .
METHODS	Chemotherapy consisted of gemcitabine 1.000 mgm ( -2 ) plus vinorelbin 25mgm ( -2 ) on days 1 +8 ( GemVin ) , or plus cisplatin 30mgm ( -2 ) on days 1 +8 ( GemCis ) , or plus capecitabine 650mgm ( -2 ) b.i.d. orally days 1-14 ( GemCap ) , q3w .
METHODS	The primary end point was response rate .
RESULTS	A total of 141 patients were recruited on the trial .
RESULTS	The overall response rates were 39.0 % ( GemVin ) , 47.7 % ( GemCis ) and 34.7 % ( GemCap ) .
RESULTS	Median progression-free survival was estimated with 5.7 , 6.9 and 8.3 months , respectively .
RESULTS	Corresponding median survival times were 17.5 ( GemVin ) , 13.0 ( GemCis ) and 19.4 months ( GemCap ) .
RESULTS	Neutropenia grade 3 occurred in 16.7 % ( Gem/Vin ) , 4.4 % ( GemCis ) and 0 % ( Gem/Cap ) , whereas non-haematological toxicities were rarely severe except grade 3 hand-foot syndrome in 2.0 % of the GemCap patients ( per patient analysis ) .
CONCLUSIONS	This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity .
CONCLUSIONS	Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer .

###10215812
BACKGROUND	Biliary reconstruction is the Achilles heel of liver transplantation .
BACKGROUND	Side-to-side anastomosis of donor and recipient bile duct has been claimed to be superior to end-to-end anastomosis in uncontrolled studies .
METHODS	A total of 100 consecutive patients undergoing orthotopic liver transplantation were randomized after commencement of the transplant procedure to end-to-end or side-to-side anastomosis .
METHODS	No T tube drainage was employed .
METHODS	Endoscopic retrograde cholangiography was performed 2 weeks after transplantation and findings were reported by an experienced endoscopist as normal , leak or stricture .
METHODS	Median follow-up was 53 ( range 35-63 ) months .
RESULTS	Patient age , sex , the graft preservation time and indication for transplantation were similar in both groups .
RESULTS	Sixty patients received end-to-end and 40 side-to-side anastomosis .
RESULTS	Ten patients randomized to side-to-side anastomosis had an end-to-end procedure .
RESULTS	The total number of biliary complications was similar in both groups ( end-to-end 32 per cent versus side-to-side 30 per cent ) as were the number of leaks ( 17 versus 18 per cent ) and biliary strictures ( 15 versus 12 per cent ) .
RESULTS	There was no difference in the number of biliary complications that required interventional treatment ( 22 per cent in both groups ) .
CONCLUSIONS	Side-to-side and end-to-end biliary anastomosis at liver transplantation are equally effective .

###15886245
OBJECTIVE	The dipeptidyl peptidase IV inhibitor , vildagliptin , increases levels of intact glucagon-like peptide-1 ( GLP-1 ) and improves glycemic control in patients with type 2 diabetes .
OBJECTIVE	Although GLP-1 is known to stimulate insulin secretion , vildagliptin does not affect plasma insulin levels in diabetic patients , suggesting that more sophisticated measures are necessary to ascertain the influence of vildagliptin on beta-cell function .
METHODS	This study examined the effects of 28-d treatment with vildagliptin ( 100 mg , twice daily ; n = 9 ) vs. placebo ( n = 11 ) on beta-cell function in diabetic patients using a mathematical model that describes the insulin secretory rate as a function of glucose levels ( beta-cell dose response ) , the change in glucose with time ( derivative component ) , and a potentiation factor , which is a function of time and may reflect the actions of nonglucose secretagogues and other factors .
RESULTS	Vildagliptin significantly increased the insulin secretory rate at 7 mmol/liter glucose ( secretory tone ) , calculated from the dose response ; the difference in least squares mean ( deltaLSM ) was 101 + / - 51 pmol.min ( -1 ) .
RESULTS	m ( -2 ) ( P = 0.002 ) .
RESULTS	The slope of the beta-cell dose response , the derivative component , and the potentiation factor were not affected .
RESULTS	Vildagliptin also significantly decreased mean prandial glucose ( deltaLSM , -1.2 + / - 0.4 mmol/liter ; P = 0.01 ) and glucagon ( deltaLSM , -10.7 + / - 4.8 ng/liter ; P = 0.03 ) levels and increased plasma levels of intact GLP-1 ( deltaLSM , +10.8 + / - 1.6 pmol/liter ; P < 0.0001 ) and gastric inhibitory polypeptide ( deltaLSM , +43.4 + / - 9.4 pmol/liter ; P < 0.0001 ) relative to placebo .
CONCLUSIONS	Vildagliptin is an incretin degradation inhibitor that improves beta-cell function in diabetic patients by increasing the insulin secretory tone .

###23855759
BACKGROUND	Previous research has shown that the use of the bispectral index ( BIS ) monitor to measure the depth of anaesthesia reduces the amount of anaesthetics administered and the recovery time from general anaesthesia .
BACKGROUND	The effect of BIS on recovery from anaesthesia and consumption of anaesthetics in a paediatric population receiving total intravenous anaesthesia ( TIVA ) with propofol and remifentanil has not been studied .
METHODS	A single-blind , single-centre clinical trial .
METHODS	One hundred fifty-seven patients were enrolled .
METHODS	They were scheduled for ear , nose , and throat surgery and stratified according to age groups ( 1-3 years , 4-11 years , 12-17 years , 18-65 years ) and type of operation , yielding a total of nine subgroups .
METHODS	Patients were randomly allocated to receive either a TIVA with propofol and remifentanil according to conventional clinical practice ( control ) or guided by BIS .
METHODS	Normalised propofol ( g/kg/min ) and remifentanil ( g/kg/min ) consumption and time to extubation ( s ) were the outcome measures .
RESULTS	Children aged 1-3 years in the BIS group had a longer time to extubation compared with controls ( P : 0.04 ) .
RESULTS	Patients aged 12-17 years in the BIS group received higher maintenance infusion rates of propofol compared with controls ( P = 0.02 ) .
RESULTS	No significant difference for the outcome variables was evidenced in the other age groups .
CONCLUSIONS	BIS monitoring for guidance of propofol-remifentanil anaesthesia does not result in reduced consumption of anaesthetics and does not reduce time to extubation in adult and children compared with conventional practice .

###21178836
METHODS	Cluster randomized controlled trial .
OBJECTIVE	To evaluate the effect of a very simple education campaign among community-dwelling 8-year-old schoolchildren .
BACKGROUND	Information has a positive effect on low back pain ( LBP ) prevention and management .
BACKGROUND	There is sparse evidence on the feasibility and effectiveness of education campaigns focusing on LBP among young schoolchildren .
METHODS	A stratified random sample of 12 schools was randomized to an intervention and a control group .
METHODS	Eight-year-old schoolchildren from these schools were given a questionnaire on LBP prevention and management at baseline , and 15 and 98 days later .
METHODS	On day 8 , teachers in the intervention group gave the schoolchildren a Comic Book of the Back , while no intervention was carried out in the control group .
METHODS	After adjusting by possible confounders , generalized estimating equations ( GEE ) models were developed to calculate the probability of `` success '' ( a score over 80 % of the maximum possible one ) .
RESULTS	Six schools ( 231 children , 46.5 % ) were assigned to the control group , and 6 ( 266 children , 53.5 % ) to the intervention one .
RESULTS	At baseline , the percentage of correct answers was above 73 % in both groups , with 8 as a median total score in the control group and 7 in the intervention group .
RESULTS	GEE showed that the odds ratio for success in the intervention group , when compared with the control group , was 1.61 ( 95 % CI : 1.03-2 .52 , P = 0.038 ) .
CONCLUSIONS	The handing out of a Comic Book of the Back slightly improves children 's knowledge of appropriate methods for the prevention and management of LBP , and the effect remains significant 3 months after intervention .

###24599947
OBJECTIVE	Attention-based coping strategies for pain are widely used in pediatric populations .
OBJECTIVE	The purpose of this study was to test a novel mindful attention manipulation on adolescent 's experimental pain responses .
OBJECTIVE	Furthermore , the relationship between state mindfulness and experimental pain was examined .
METHODS	A total of 198 adolescents were randomly assigned to a mindful attention manipulation or control group prior to an experimental pain task .
METHODS	Participants completed measures of state mindfulness immediately prior to the pain task , and situational catastrophizing and pain intensity following the task .
RESULTS	Overall the manipulation had no effect on pain .
RESULTS	Secondary analysis showed that meditation experience moderated the effect of the manipulation .
RESULTS	State mindfulness predicted pain outcomes , with reductions in situational catastrophizing mediating this relationship .
CONCLUSIONS	The mindful attention manipulation was effective among adolescents with a regular meditation practice .
CONCLUSIONS	State mindfulness was related to ameliorated pain responses , and these effects were mediated by reduced catastrophizing .

###8632120
OBJECTIVE	The sensitivity of one plasma and two urinary methods to assess zinc absorption after oral dosing were compared over the dose range of 10 to 100 mg .
METHODS	Eleven healthy subjects participated in this four-way crossover design study .
METHODS	After an overnight fast , the subjects received a single oral dose of zinc acetate corresponding to 10 , 25 , 50 , or 100 mg of elemental zinc .
METHODS	Plasma zinc concentrations were measured at baseline ( pre-zinc administration ) and hourly intervals post-zinc administration for 9 hours .
METHODS	Urine was collected for 24 hours prior to and for 24 hours after zinc administration .
METHODS	During this 48-hour period , subjects consumed an isocaloric , caffeine-free diet containing 18 mg of elemental zinc per day .
RESULTS	The area under the plasma zinc concentration versus time curve ( PZAUC ) increased linearly with doses between 10 and 50 mg , then flattened out .
RESULTS	By contrast , urinary zinc excretion was approximately linear with doses in the 25 to 100 mg range , but no differences were observed in urinary zinc excretion after doses of 10 and 25 mg .
CONCLUSIONS	Plasma zinc concentration is a useful method of evaluating oral zinc absorption from doses of 10 to 50 mg .
CONCLUSIONS	Urinary zinc excretion is an alternative method of assessing zinc absorption , particularly when doses of 50 to 100 mg of elemental zinc are administered .

###11340558
OBJECTIVE	To determine thermal necrosis zone and the maximal temperature achieved with various electrocautery doses applied to the pubic symphysis of immature dogs , and to establish the minimal electrocautery dose needed to affect thermal necrosis of the germinal chondrocytes of the immature canine pubis .
METHODS	A randomized , controlled , prospective study .
METHODS	Twelve puppies , 15 to 17 weeks of age .
METHODS	Each treated puppy was randomly selected to receive 3 of 33 possible doses of electrical current applied at uniform intervals along the pelvic symphysis .
METHODS	Three treatment sites were sham-operated controls .
METHODS	All treatment zones were biopsied 7 days after application of electrocautery .
METHODS	Confocal laser microscopy with calcein green and ethidium homodimer red stains were used to determine cell type and viability within treatment and control zones .
METHODS	The physeal diameter and thermal necrosis zone were measured .
METHODS	Thermal necrosis zone and dose , and temperature and dose were compared using regression analysis .
METHODS	Prediction equation analysis was used to establish dose recommendations .
RESULTS	Doses of 40 W produced a highly significant linear relationship ( R ( 2 ) = .88 , P < .01 ) with thermal necrosis zone , and a significant linear relationship ( R ( 2 ) = .76 , P < .02 ) with maximal temperature .
CONCLUSIONS	The thermal necrosis zone within the pelvic symphysis and maximal temperature achieved can be reliably predicted using electrocautery doses of 40 W. For application of electrocautery to induce pubic symphysiodesis , doses should be chosen based on measured or estimated physeal size .
CONCLUSIONS	Using prediction equation analysis , the surgeon can plan mean thermal necrosis zone with acceptable variance .
CONCLUSIONS	Unipolar needle electrocautery can be used to reliably achieve symphyseal necrosis .
CONCLUSIONS	Prediction equation analysis can be used to determine 40-W doses .

###21946475
OBJECTIVE	We investigated the outcomes of three home blood pressure measurement ( HBPM ) education programs on adult knowledge and practice .
METHODS	We chose a pretest/post-test design and randomly divided 95 adults into three groups : individual training ( group A ) , group training ( group B ) , and self-learning ( group C ) , for education regarding HBPM in accordance with the Canadian Hypertension Education Program .
METHODS	Participants involved in groups A and B received interactive education led by a nurse .
METHODS	Participants in group C learned by themselves using an instruction booklet and a HBPM device lent to them for 7 days .
METHODS	Knowledge was assessed pretest and post-test by questionnaire .
METHODS	Skills were evaluated postintervention by direct observation .
RESULTS	Analysis of the 60 participants indicated significant knowledge improvement .
RESULTS	Pretest scores of 38 ( group A ) , 54 ( group B ) , and 45 % ( group C ) rose significantly to 97 , 99 , and 90 % , respectively ( pretest vs. post-test ; P < 0.0001 ) .
RESULTS	Individual and group training sessions were significantly more effective compared with the self-learning program , which was confirmed by differences between groups in post-test practice .
RESULTS	Assessment scores : 74 ( group A ) , 79 ( group B ) , and 53 % ( group C ; group A vs. group C ; P = 0.001 , group B vs. group C ; P = 0.001 ) .
CONCLUSIONS	Our findings indicate that adults attending an individual or group training program for HBPM retained its theoretical and practical principles better than those engaged in self-learning .
CONCLUSIONS	Their success may be attributed to interaction with the nurse .

###22099625
OBJECTIVE	This study aimed to compare the acute effects of nicardipine and esmolol on hemodynamic and endothelial shear stress ( ESS ) in patients with unstable angina ( UA ) and moderate coronary stenosis ( MCS ) .
BACKGROUND	Nicardipine and esmolol exhibit cardioprotection via different mechanisms .
BACKGROUND	However , their acute effects on hemodynamic and ESS are still unknown .
METHODS	One-hundred sixteen patients with UA and MSC were randomly divided into nicardipine ( n = 59 ) and esmolol ( n = 57 ) groups .
METHODS	Drugs were injected as a bolus followed by continuous infusion to achieve the steady states defined as the mean blood pressure ( MBP ) reduced by 10 % or a heart-rate change by 15 bpm , lasting for at least 10 min .
METHODS	The aortic pressure ( AP ) , EKG , blood velocity , right atrial pressure , distal coronary pressure ( DCP ) , systolic time ( ST ) , isovolumetric diastolic time ( IVDT ) , speed filling time ( SFT ) , and ESS were simultaneously calculated at baseline and steady states .
RESULTS	Both drugs significantly reduced blood pressure and rate-pressure load .
RESULTS	Infusion of nicardipine was associated with negative remodeling of the distal segment ( P = 0.005 ) .
RESULTS	Esmolol , rather than nicardipine , increased minimal lumen diameter ( P = 0.040 ) , prolonged SFT ( 0.34 0.03 s vs. 0.41 0.03 s , P < 0.001 ) , reduced DCP ( P < 0.001 ) and increased blood velocity ( 33.65 1.07 cm/s vs. 43.36 1.25 cm/s , P < 0.001 ) at SFT stages , with increased blood-flow ( P < 0.001 ) .
RESULTS	Both drugs increased downstream ESS .
RESULTS	Esmolol significantly reversed abnormally increased ESS ( P < 0.001 ) and increased upstream ESS compared with nicardipine ( P < 0.001 ) .
CONCLUSIONS	Beyond a similar reduction of AP , patients with UA and MCS could benefit more from the reduction of heart rate induced by esmolol ( ChiCTR-TRC-10000964 ) .

###16842467
BACKGROUND	The clinical management of Helicobacter pylori infected patients who failed standard eradication therapies remains a challenge .
OBJECTIVE	To investigate the efficacy of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of H. pylori , and the correlation between cytochrome P450 2C19 ( CYP2C19 ) polymorphisms and treatment outcome .
METHODS	Patients infected with H. pylori resistant to both metronidazole and clarithromycin ( n = 145 ) were randomized to either esomeprazole 20 mg , rifabutin 150 mg and amoxicillin 1 g , each given b.d. for 7 days ( ERA ) , or to omeprazole 40 mg and amoxicillin 1000 mg , each given t.d.s. for 14 days ( OA ) .
METHODS	Crossover therapy was offered in cases of persistent infection .
METHODS	CYP2C19 polymorphisms were determined by polymerase chain reaction restriction fragment length polymorphism .
RESULTS	Intention-to-treat and per-protocol eradication rates were : ERA 74 % ( 62.4-83 .6 ) and 78 % ( 66.7-87 .3 ) ; high-dose OA 70 % ( 57.5-79 .7 ) and 75 % ( 62.5-84 .5 ) .
RESULTS	Crossover therapy was successful in seven of 10 patients with ERA and in eight of 10 patients with OA .
RESULTS	Premature discontinuation of treatment occurred in 2 % and 5 % of patients , respectively .
RESULTS	There was only a non-significant trend to lower eradication rates in homozygous extensive metabolizers .
CONCLUSIONS	Triple therapy with esomeprazole , rifabutin and amoxicillin and high-dose omeprazole/amoxicillin are comparable and effective and safe for rescue therapy of H. pylori regardless of the patient 's CYP2C19 genotype .

###9566100
BACKGROUND	Leukotrienes and prostaglandines are important mediators of inflammation .
BACKGROUND	While prostaglandine synthesis can be influenced by NSAIDs therapeutical approaches to the 5-lipoxygenase pathway are rare .
BACKGROUND	Resinous extracts of Boswellia serrata ( H15 , indish incense ) , known from traditional ayurvedic medicine , decrease leukotriene synthesis in vitro .
BACKGROUND	Case reports suggest a clinical role for that drug .
METHODS	Outpatients with active RA have been enrolled into a multicenter controlled trial .
METHODS	Patients received 9 tablets of active drug ( 3600 mg ) or placebo daily in addition to their previous therapy .
METHODS	Doses of NSAIDs could be adjusted on demand .
METHODS	Efficacy parameters , Ritchies Index for swelling and pain , ESR , CRP , pain on VAS and NSAID dose were documented at baseline and 6 and 12 weeks after initiation .
METHODS	Mean values and medians were calculated to compare the groups for significant or clinically relevant change from baseline or difference between both groups at any time point of observation .
RESULTS	A total of 78 patients were recruited in 4 centers , the data have been published in abstract form .
RESULTS	Only 37 patients ( verum 18 , placebo 19 ) , enrolled in Ratingen were available for detailed efficacy and safety analysis .
RESULTS	All evaluations in these patients were performed by one investigator ( G.H. ) .
RESULTS	There was no subjective , clinical or laboratory parameter showing a significant or clinically relevant change from baseline or difference between both groups at any time point of observation .
RESULTS	The mean NSAID dose reduction reached levels of 5.8 % ( H15 ) and 3.1 % ( placebo ) .
RESULTS	One patient in each group showed a good response in all parameters but 4 patients in each group worsened .
RESULTS	The others showed no alteration of their disease .
CONCLUSIONS	Treatment with H15 showed no measurable efficacy .
CONCLUSIONS	Controlled studies including a greater patient population are necessary to confirm or reject our results .

###17803204
BACKGROUND	Beta-blockers exert complex effects on plasma N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) level .
OBJECTIVE	We aimed to investigate whether NT-proBNP was still able to mirror the severity of chronic heart failure and predict the prognosis of the disease after administration of a beta-blocker .
METHODS	Forty-four patients with chronic congestive heart failure were enrolled in the study to randomly receive carvedilol or bisoprolol in addition to background therapy .
METHODS	These patients underwent clinical measurement and blood sampling for NT-proBNP measurement at baseline and 3 or 7 months after the addition of the beta-blocker .
METHODS	The patients were followed-up for 3 years in order to register the occurrence of all-cause death .
RESULTS	NT-proBNP level showed a positive correlation with the severity of heart failure as evaluated by New York Heart Association ( NYHA ) classification both before and after administration of either beta-blocker .
RESULTS	The relationship between NT-proBNP and NYHA class was not weakened with the duration of therapy .
RESULTS	Furthermore , NT-proBNP was the only independent predictor of all-cause mortality both before and after administration of either beta-blocker .
RESULTS	Left ventricular ejection fraction ( LVEF ) , left ventricular end diastolic diameter ( LVEDD ) , age , NYHA class and treatment group were not independently predictive of mortality in this study .
CONCLUSIONS	The ability of NT-proBNP to reflect the severity and to predict the endpoint in chronic heart failure is not undermined after administration of a beta-blocker , suggesting that NT-proBNP remains a sensitive biomarker for chronic heart failure both before and after administration of a beta-blocker .

###11908554
OBJECTIVE	This Phase III , placebo and active controlled , multicenter trial evaluated the efficacy and safety of meloxicam 7.5 , 15 , and 22.5 mg daily for the treatment of rheumatoid arthritis ( RA ) .
METHODS	A 12 week , randomized , double blind , double dummy , parallel group trial compared daily oral meloxicam 7.5 , 15 , and 22.5 mg to placebo ( negative control ) and diclofenac 75 mg BID ( positive control ) .
METHODS	A total of 894 patients ( 18 years of age with confirmed RA who flared following an NSAID-free period ) were randomized to be treated .
METHODS	Baseline scores for all endpoints were similar among the treatment groups .
METHODS	Patient assessments were at 0 , 2 , 4 , 8 , and 12 weeks or early termination .
RESULTS	All treatment groups demonstrated significant improvement from baseline ( p < 0.001 ) .
RESULTS	Meloxicam 7.5 and 22.5 mg was significantly superior to placebo in all 5 primary efficacy endpoints ( swollen joint count , tender joint count , patient pain , patient and physician global ; all p < 0.05 ) .
RESULTS	Diclofenac 150 mg was superior to placebo for 4 of 5 primary efficacy measures ( all but swollen joint count ; p < 0.05 ) and meloxicam 15 mg was superior for 3 of 5 primary endpoints ( patient pain and patient and physician global ) .
RESULTS	AUC of patient global , patient pain , and modified Health Assessment Questionnaire demonstrated dose-response ( p < 0.04 ) , while AUC ACR20 showed a qualitative trend in the same direction .
RESULTS	The rate of gastrointestinal ( GI ) events during the 12 week trial for all doses of meloxicam and diclofenac did not differ significantly from placebo ( 23.2-32 .0 % ) .
RESULTS	GI withdrawals were comparable and not significantly different across all treatment groups ( 4.3-5 .7 % ) .
CONCLUSIONS	This trial demonstrated a dose response relationship for meloxicam 7.5 , 15 , and 22.5 mg using AUC measurement of response for the treatment of RA .
CONCLUSIONS	All 3 doses of meloxicam .
CONCLUSIONS	and positive control , were effective in the treatment of RA .
CONCLUSIONS	The overall incidence rate of GI events did not differ significantly from placebo in either the meloxicam treatment groups or the positive control .

###18982784
OBJECTIVE	To compare the utility of intra-articular analgesia ( IA ) to that of a continuous interscalene block ( CIB ) by evaluating the quality of postoperative analgesia , a satisfaction index , and the incidence of complications .
METHODS	A randomized controlled trial enrolling patients classified as ASA 1 or 2 .
METHODS	The IA group received 25 mL of ropivacaine 0.2 % plus 2 mg of morphine .
METHODS	The CIB group received a 7-mL/h infusion of bupivacaine 0.0625 % plus 1 microg/mL of sufentanil .
METHODS	Postoperative pain was expressed on a visual analog scale ( VAS ) at 2 , 4 , 6 , 12 , 24 , and 48 hours .
METHODS	Intravenous morphine was used as a rescue analgesic .
METHODS	Morphine use , incidence of adverse effects , and level of patient satisfaction after 48 hours were recorded .
RESULTS	Twenty-three patients were randomized to the IA group and 24 to the CIB group .
RESULTS	There were no between-group differences in patient characteristics .
RESULTS	VAS scores and morphine use were similar in the 2 groups in the first 12 hours but were lower in the CIB group at 24 and 48 hours .
RESULTS	The level of patient satisfaction was higher in the CIB group .
RESULTS	There was a higher incidence of nausea and/or vomiting in the IA group at 24 and 48 hours .
CONCLUSIONS	Postoperative pain in the first 12 hours after shoulder surgery can be adequately managed with either IA or CIB .
CONCLUSIONS	CIB is more effective than IA between 12 and 48 hours after surgery .

###15017504
OBJECTIVE	To compare the efficacy of controlled-release budesonide capsules with that of mesalamine for maintaining remission and improving quality of life ( QOL ) in patients with steroid-dependent Crohn 's disease .
METHODS	Fifty-seven patients ( 25 men ; mean age , 32 + / - 10.1 yr ) with quiescent steroid-dependent Crohn 's ileitis , ileocolitis , or colitis ( Crohn 's disease activity index < 150 ) entered a prospective , investigator-blind trial .
METHODS	Patients were eligible for treatment with azathioprine but had not consented or had developed side effects .
METHODS	Patients were randomized to receive budesonide 6 mg/day ( n = 29 ) or mesalamine 1 g 3 times/day ( n = 28 ) .
METHODS	Follow-up assessments were made every 2 months for up to 1 year or until relapse .
METHODS	At each visit , quality of life ( QOL ) was assessed using the Inflammatory Bowel Disease Questionnaire ( IBDQ ) .
RESULTS	There were no significant differences in baseline clinical characteristics between the study groups .
RESULTS	The 1-year relapse rate was significantly lower in the budesonide group than in the mesalamine group ( 55 % vs. 82 % ; 95 % confidence interval , 12.4 % -41 % ; P = 0.045 ) .
RESULTS	Patients assigned to budesonide also remained in remission longer ( 241 + / - 114 days vs. 147 + / - 117 days ; 95 % confidence interval , 32.7-155 .3 days ; P = 0.003 ) .
RESULTS	Compared with mesalamine , budesonide treatment also was associated with a better QOL throughout the study ( mean total IBDQ scores 165 + / - 36 vs. 182 + / - 28 , respectively ; 95 % confidence interval , -0.4 to 34.4 , P = 0.0001 ) .
RESULTS	This advantage was confirmed in patients ' self-assessed QOL scores .
CONCLUSIONS	Over a 1-year period , controlled-release budesonide was significantly more effective than mesalamine for maintaining remission and improving the QOL of patients with steroid-dependent Crohn 's disease .

###23868159
OBJECTIVE	Independent evaluation of angiographic images is becoming widely applied in the assessment of treatment outcomes of cerebral aneurysms .
OBJECTIVE	In the current study , we assessed the agreement between an independent core laboratory and the operators regarding angiographic appearance in a recent randomized , controlled trial .
METHODS	Data were derived from the Cerecyte Coil Trial .
METHODS	Angiographic images of each coiled aneurysm , taken immediately after embolization and at 5 - to 7-month follow-up , were evaluated by the operator at the treating center and by an independent neuroradiologist at the core laboratory .
METHODS	For the purpose of this study , images were interpreted on a 3-point scale to provide uniformity for analysis ; grade 1 : complete occlusion , grade 2 : neck remnant ; and grade 3 : sac filling .
METHODS	`` Unfavorable angiographic appearance '' was defined as grade 3 at follow-up or interval worsening of grade between the 2 time points .
RESULTS	The study included 434 aneurysms .
RESULTS	Immediately after embolization , grade 3 was reported by operators in 39 ( 9 % ) compared with 52 ( 12 % ) by the core laboratory ( P = .159 ) .
RESULTS	On follow-up , grade 3 was reported by operators in 44 ( 10 % ) compared with 81 ( 19 % ) by the core laboratory ( P < .0001 ) .
RESULTS	Overall , operators noted unfavorable angiographic appearance in 78 ( 18 % ) compared with 134 ( 31 % ) by the core laboratory ( P < .0001 ) .
RESULTS	At every time point , agreement between the core laboratory and the operators was slight .
CONCLUSIONS	Unfavorable angiographic appearance was noted almost twice as frequently by an independent core laboratory as compared with the operators .
CONCLUSIONS	Planning of trials and interpretation of published studies should be done with careful attention to the mode of angiographic appearance interpretation .

###18093504
OBJECTIVE	To determine the cut-off point of calcaneous quantitative ultrasound densitometry ( QUS ) as a selection method in primary care for referral of postmenopausal women for dual energy x-ray absorptiometry ( DXA ) .
METHODS	Diagnostic techniques trial .
METHODS	Four general practices in the Basque Country Autonomous Region , Spain .
METHODS	Randomly selected Caucasian women older than 45 , chosen at random .
METHODS	A sample size of 146 women was used .
METHODS	Calcaneous ultrasound bone mineral density ( BMD ) measurement , using Achilles Express ( R ) and DXA .
METHODS	T-score BMD measurement on both devices .
METHODS	The sensitivity , specificity and positive predictive values of QUS and finally the ideal cut-off value were calculated .
RESULTS	The mean age of the sample was 58.2 ( 17.7 ) ( range , 48-83 years old ) .
RESULTS	The prevalence of women with osteoporosis , osteopaenia and normal DXA was 14.1 % , 50.4 % and 35.5 % , respectively .
RESULTS	The estimated sensitivity of QUS was 78.9 % ( 56.7-91 .5 ) and the specificity was 64.7 % ( 55.6-72 .8 ) .
RESULTS	The negative predictive value ( NPV ) was 94.9 % ( 87.7-98 .0 ) and the positive predictive value ( PPV ) was 26.8 % ( 17.0-39 .6 ) .
RESULTS	After the COR curve analysis , the ideal cut-off for QUS was determined as a T-score < / = -2.0 .
CONCLUSIONS	Given its high NPV , QUS can be considered a useful device for screening before DXA .
CONCLUSIONS	Its low PPV means it has to be combined with other complementary or substitutive selective screening methods , such as predictive rules , which should be evaluated in each specific use .

###9667297
BACKGROUND	The addition of opioids to epidural infusions for laboring mothers may reintroduce the problem of neonatal depression seen with systemic opioids .
BACKGROUND	The authors studied neonatal respiration and neurobehavior in newborns of mothers randomized to receive epidural analgesia with or without fentanyl .
METHODS	One hundred thirty-eight women in labor received loading doses of plain bupivacaine .
METHODS	When pain-free , they received an infusion of either 0.125 % bupivacaine alone or 0.0625 % bupivacaine with 2.5 microg/ml fentanyl .
METHODS	After delivery , transcutaneous oxygen tension and carbon dioxide tension were recorded in the newborns every 10 s until 90 min after delivery using a transcutaneous oxygen-carbon dioxide monitor .
METHODS	Umbilical venous and arterial acid-base status , Apgar scores , and Neurologic and Adaptive Capacity Scores 2 h and 24 h after delivery were measured .
METHODS	The umbilical venous plasma fentanyl concentration was correlated with indices of neonatal respiration and welfare in the fentanyl group .
RESULTS	One hundred fourteen newborns delivered vaginally were studied .
RESULTS	In the fentanyl group , the mean ( range ) maternal dose of fentanyl was 184 microg ( range , 53-400 ) , and the umbilical venous fentanyl concentration was 0.077 ng/ml ( range , < 0.021 to 0.244 ) .
RESULTS	There were no significant differences between the groups for any indices of neonatal respiration or neonatal welfare , and the plasma fentanyl concentration did not correlate with any of these indices .
CONCLUSIONS	The results suggest that fentanyl added to epidural bupivacaine infusions during labor does not depress neonatal respiration or adversely affect neurobehavioral scores and other indices of neonatal welfare .

###14742344
BACKGROUND	Although the synergistic interaction between hypnotics and opioids for total i.v. anaesthesia has been repeatedly demonstrated , questions about different dose combinations of hypnotics and opioids remain .
BACKGROUND	The optimal combination would be based on maximal synergy , using the lowest dose of both drugs and having the lowest incidence of side-effects .
METHODS	The major goal of this prospective randomized study was to compare two different dose combinations of propofol and remifentanil ( both administered by target controlled infusion ( TCI ) ) in respect of haemodynamics during surgery and recovery , and the need for cardiovascular treatment in the recovery room .
METHODS	A secondary goal was to compare pain scores ( VAS ) and morphine consumption in the recovery room .
METHODS	Anaesthesia was induced in both groups using TCI propofol , adjusted to obtain a bispectral index score ( BIS ) value between 40 and 60 .
METHODS	TCI for remifentanil commenced at an initial effect-site concentration of 0.5 ng ml ( -1 ) , and was adjusted according to haemodynamics .
METHODS	Patients were divided into one of two groups during anaesthesia : ( i ) .
METHODS	Group H , hypnotic anaesthesia ( n = 23 ) , propofol effect-site concentration maintained at 2.4 microg x ml ( -1 ) ; and ( ii ) .
METHODS	Group O , opioid anaesthesia ( n = 23 ) , propofol effect-site concentration maintained at 1.2 microg x ml ( -1 ) .
METHODS	In both groups , remifentanil effect-site concentration was adjusted according to haemodynamics and changes in BIS value .
RESULTS	In Group O , more episodes of intraoperative hypotension ( P < 0.02 ) and hypertension ( P < 0.01 ) , and fewer episodes of tachycardia were observed .
RESULTS	More patients in Group O required nicardipine administration for postoperative hypertension ( 8 patients in Group H vs 15 patients in Group O , P < 0.04 ) .
RESULTS	During recovery , morphine titration was necessary in approximately 50 % of patients .
RESULTS	No significant difference between groups was observed concerning pain scores or requirement for morphine titration .
CONCLUSIONS	Maintenance of anaesthesia predominantly with propofol and a low dose of remifentanil , both administered using TCI , is associated with greater stability in perioperative haemodynamics than anaesthesia predominantly with remifentanil alone .
CONCLUSIONS	Postoperative pain was identical in both groups of patients who underwent relatively short duration , and relatively painless surgery .

###19071061
BACKGROUND	Laparoscopic surgery for colon cancer has been proven safe , but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer .
BACKGROUND	The aim of the COlon cancer Laparoscopic or Open Resection ( COLOR ) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer .
METHODS	Between March 7 , 1997 , and March 6 , 2003 , patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m ( 2 ) were randomly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority randomised trial .
METHODS	Disease-free survival at 3 years after surgery was the primary outcome , with a prespecified non-inferiority boundary at 7 % difference between groups .
METHODS	Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , and blood loss during surgery .
METHODS	Neither patients nor health-care providers were blinded to patient groupings .
METHODS	Analysis was by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00387842 .
RESULTS	During the recruitment period , 1248 patients were randomly assigned to either open surgery ( n = 621 ) or laparoscopic surgery ( n = 627 ) .
RESULTS	172 were excluded after randomisation , mainly because of the presence of distant metastases or benign disease , leaving 1076 patients eligible for analysis ( 542 assigned open surgery and 534 assigned laparoscopic surgery ) .
RESULTS	Median follow-up was 53 months ( range 0.03-60 ) .
RESULTS	Positive resection margins , number of lymph nodes removed , and morbidity and mortality were similar in both groups .
RESULTS	The combined 3-year disease-free survival for all stages was 74.2 % ( 95 % CI 70.4-78 .0 ) in the laparoscopic group and 76.2 % ( 72.6-79 .8 ) in the open-surgery group ( p = 0.70 by log-rank test ) ; the difference in disease-free survival after 3 years was 2.0 % ( 95 % CI -3.2 to 7.2 ) .
RESULTS	The hazard ratio ( HR ) for disease-free survival ( open vs laparoscopic surgery ) was 0.92 ( 95 % CI 0.74-1 .15 ) .
RESULTS	The combined 3-year overall survival for all stages was 81.8 % ( 78.4-85 .1 ) in the laparoscopic group and 84.2 % ( 81.1-87 .3 ) in the open-surgery group ( p = 0.45 by log-rank test ) ; the difference in overall survival after 3 years was 2.4 % ( 95 % CI -2.1 to 7.0 ; HR 0.95 [ 0.74-1 .22 ] ) .
CONCLUSIONS	Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95 % CI for the difference just exceeded the predetermined non-inferiority boundary of 7 % .
CONCLUSIONS	However , the difference in disease-free survival between groups was small and , we believe , clinically acceptable , justifying the implementation of laparoscopic surgery into daily practice .
CONCLUSIONS	Further studies should address whether laparoscopic surgery is superior to open surgery in this setting .

###11553245
OBJECTIVE	Hypothermia may alter the disposition of opioids .
OBJECTIVE	Because opioids are commonly used as analgesics in the postoperative period , it is of clinical interest to clarify whether perioperatively developed hypothermia affects postoperative opioid requirements .
METHODS	Fifty-nine patients undergoing subtotal hysterectomy were prospectively randomized and either treated intraoperatively with forced air warming , or served as controls covered with conventional blankets without active warming .
METHODS	Both groups received postoperative patient-controlled analgesia with the opioid ketobemidone .
METHODS	Total analgesic requirements , demands , analgesic requirements over 6-h intervals and pain scores were measured for 48 h. Core temperature at the tympanic membrane and ambient room temperature were measured during the perioperative period .
RESULTS	There were no postoperative differences in analgesic requirements or pain intensity between normothermic and hypothermic patients .
RESULTS	Patients treated with warm air had an up to 1 degree C higher core temperature from 0.5 h after anaesthesia induction until almost 2 h postoperatively .
RESULTS	The actively warmed patients also had a lower intraoperative blood loss than the hypothermic patients ( 186 + / - 27 mL vs. 308 + / - 47 mL ; P < 0.05 ) .
CONCLUSIONS	In a clinical setting , opioid requirements do not seem to be affected by mild postoperative hypothermia after lower abdominal surgery .

###18375876
BACKGROUND	There is growing interest in geriatric care for community-dwelling older people .
BACKGROUND	There are , however , relatively few reports on the economics of this type of care .
BACKGROUND	This article reports about the cost-effectiveness of the Dutch Geriatric Intervention Program ( DGIP ) compared to usual care in frail older people at 6-month follow-up from a health care system 's point of view .
METHODS	We conducted this economic evaluation in an observer-blind randomized controlled trial ( Dutch EASYcare Study : ClinicalTrials.gov Identifier NCT00105378 ) .
METHODS	Difference in treatment effect was calculated as the difference in proportions of successfully treated patients ( prevented functional decline accompanied by improved well-being ) .
METHODS	Incremental treatment costs were calculated as the difference in mean total care costs .
METHODS	The incremental cost-effectiveness ratio ( ICER ) was expressed as total cost per successful treatment .
METHODS	Bootstrap methods were used to determine confidence intervals ( CI ) for these measures .
RESULTS	The average cost of the intervention under study ( DGIP ) was 998 euros ( 95 % CI , 888-1108 ) .
RESULTS	The increment in total cost resulting from DGIP was a little over 761 euros ( -3336 to 4687 ) .
RESULTS	Hospitalization and institutionalization costs were less ; home care , adult day care , and meals-on-wheels costs were higher .
RESULTS	There was a significant difference in proportions of successful treatments of 22.3 % ( 4.3-41 .4 ) .
RESULTS	The number needed to treat was approximately 4.7 ( 2.3-18 .0 ) .
RESULTS	The ICER is 3418 euros per successful treatment ( -21,458 to 45,362 ) .
RESULTS	The new treatment is cost-effective at a willingness-to-pay of 34,000 euros .
CONCLUSIONS	The results of this economic evaluation suggest that DGIP is an effective addition to primary care for frail older people at a reasonable cost .

###24850615
BACKGROUND	We studied whether a 6-month group-mediated cognitive behavioral ( GMCB ) intervention for peripheral artery disease ( PAD ) participants , which promoted home-based walking exercise , improved 6-minute walk and other outcomes at 12-month follow-up , 6 months after completing the intervention , compared to a control group .
RESULTS	We randomized PAD participants to a GMCB intervention or a control group .
RESULTS	During phase I ( months 1 to 6 ) , the intervention used group support and self-regulatory skills during weekly on-site meetings to help participants adhere to home-based exercise .
RESULTS	The control group received weekly on-site lectures on topics unrelated to exercise .
RESULTS	Primary outcomes were measured at the end of phase I.
RESULTS	During phase II ( months 7 to 12 ) , each group received telephone contact .
RESULTS	Compared to controls , participants randomized to the intervention increased their 6-minute walk distance from baseline to 12-month follow-up , ( from 355.4 to 381.9 m in the intervention versus 353.1 to 345.6 m in the control group ; mean difference = +34.1 m ; 95 % confidence interval [ CI ] = +14.6 , +53.5 ; P < 0.001 ) and their Walking Impairment Questionnaire ( WIQ ) speed score ( from 36.1 to 46.5 in the intervention group versus 34.9 to 36.5 in the control group ; mean difference = +8.8 ; 95 % CI = +1.6 , +16.1 ; P = 0.018 ) .
RESULTS	Change in the WIQ distance score was not different between the 2 groups at 12-month follow-up ( P = 0.139 ) .
CONCLUSIONS	A weekly on-site GMCB intervention that promoted home-based walking exercise intervention for people with PAD demonstrated continued benefit at 12-month follow-up , 6 months after the GMCB intervention was completed .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	Unique identifier : NCT00693940 .

###16286549
BACKGROUND	Reported rates of mild cognitive impairment ( MCI ) range widely depending on methodologic differences , including specific sample characteristics , cognitive measures used , normative samples used for neuropsychological tests , and diagnostic criteria .
OBJECTIVE	To operationalize diagnostic criteria for MCI and examine the frequency of MCI in ethnically and linguistically diverse elders ( individuals older than 65 years ) .
METHODS	Prospective , community-based longitudinal cohort study .
METHODS	Northern Manhattan , New York , NY .
METHODS	A cohort of 1315 nondemented elderly participants .
METHODS	A diagnosis of MCI was assigned retrospectively on the basis of comprehensive neuropsychological , functional , and neurologic assessments .
METHODS	Amnestic MCI , as well as forms of mild impairment with other cognitive characteristics , were classified .
RESULTS	The frequency of amnestic MCI was 5.0 % ( 95 % confidence interval , 3.8-6 .2 ) .
RESULTS	Other subtypes of MCI ranged in frequency from 2.1 % to 6.2 % .
RESULTS	Mild cognitive impairment was more common among those older than 75 years compared with those aged 65 to 75 years .
RESULTS	Individuals with fewer than 9 years of schooling were more likely to meet MCI criteria .
RESULTS	Apolipoprotein ( APOE ) E4 allele was more frequent among those with amnestic MCI .
CONCLUSIONS	When proper normative values are used , only age and education , and not race or ethnicity , are associated with higher frequency of MCI .
CONCLUSIONS	The proportion of nondemented elders with isolated memory deficits is smaller than the proportion with deficits in multiple cognitive domains .
CONCLUSIONS	The strong association of the APOE E4 allele with only amnestic MCI suggests that there are likely to be multiple causes of cognitive impairment and differential rates of conversion to Alzheimer disease within the cognitive subtypes of MCI .

###25623102
OBJECTIVE	To explore the clinical efficacies of different internal fixation materials in the treatment of senile proximal humerus fractures .
METHODS	A total of 284 hospitalized patients of proximal humerus fractures over 60 years of age cases from October 2009 to February 2012 were randomly divided into two groups of locking proximal humeral plate ( LPHP ) and PHILOS ( n = 142 each ) .
METHODS	And the clinical efficacies of two groups were compared .
RESULTS	For PHILOS and LPHP groups , the fracture healing periods were ( 11.64 3.81 ) and ( 14.95 3.95 ) weeks .
RESULTS	And there was statistical significance ( P < 0.05 ) .
RESULTS	At 3 months post-surgery , the incidence of pain was 72.41 % and 64.81 % .
RESULTS	And there was statistical significance ( P < 0.05 ) .
RESULTS	At 2 years , Neer shoulder function score had inter-group statistically insignificant difference ( P > 0.05 ) .
CONCLUSIONS	Both PHILOS and LPHP are effective in the treatment of senile proximal humeral fractures.However , the former is conducive to fracture healing and has shorter healing time and lowered postoperative pain .

###16209971
BACKGROUND	Multidisciplinary heart failure ( HF ) programs reduce hospital readmission and improve clinical outcomes .
BACKGROUND	Although dietitians are often members of such teams , no randomized studies have demonstrated the independent benefit of dietitian-administered dietary counseling for patients with HF .
BACKGROUND	The purpose of this study was to evaluate the effect of dietitian education on adherence to a sodium-restricted diet in ambulatory patients with stable HF .
METHODS	Patients with HF ( left ventricular ejection fraction < 35 % ) were randomized into a dietitian education group ( n = 23 ) or a usual care group ( n = 24 ) , then observed for 3 months .
METHODS	Both groups received a 2 g/d dietary sodium prescription .
METHODS	The usual care group received nutrition advice by way of self-help literature , whereas the dietitian education group returned for 2 counseling sessions with a dietitian .
RESULTS	Dietitian education resulted in a significant decrease in sodium intake at 3 months ( 2.80 + / - 0.30 to 2.14 + / - 0.23 g/d , P < .05 ) .
RESULTS	In contrast , there was no change in sodium intake in the usual care group ( 3.00 + / - 0.31 to 2.74 + / - 0.35 g/d , P = ns ) .
CONCLUSIONS	Dietitian-administered counseling was more effective than providing literature in reducing dietary sodium intake in patients with stable HF .

###21300334
OBJECTIVE	To investigate the impact on the number of cumulus-oocyte complexes ( COC ) when a 3-day course of GnRH antagonist treatment precedes the initiation of controlled ovarian stimulation with gonadotropins in a GnRH antagonist protocol for IVF/intracytoplasmic sperm injection ( ICSI ) .
METHODS	Randomized controlled trial .
METHODS	Tertiary referral center .
METHODS	Sixty-nine women undergoing controlled ovarian hyperstimulation for IVF/ICSI .
METHODS	The control group ( n = 36 ) received a standard treatment with daily injections of recombinant FSH ( rFSH ) , starting on day 2 of the cycle at a dose of 150-225 IU/day , and GnRH antagonists from cycle day 7 onward .
METHODS	In the pretreatment group ( n = 33 ) , a GnRH antagonist was administered from day 2 of the menstrual cycle onward during 3 consecutive days ; thereafter controlled ovarian stimulation was initiated with the same protocol as used in the control group .
METHODS	The primary endpoint was the number of COCs at egg retrieval .
RESULTS	Both groups had comparable baseline characteristics .
RESULTS	The duration of rFSH stimulation and consumption of gonadotropins were similar in both groups .
RESULTS	The number of COCs was higher in the pretreatment group ( 12.8 ; SD , 7.8 ) compared with in the control group ( 9.9 ; SD , 4.9 ) , although this increment was not significant ( between-group difference of 2.9 [ 95 % confidence interval { CI } -0.2 to 6.0 ] ) .
RESULTS	The ongoing pregnancy rates per started cycle of 14/33 ( 42 % ) versus 12/36 ( 33 % ) for pretreatment versus control did not differ significantly ( between-group difference , 9.1 % ; 95 % CI , -13 % to 30 % ) .
CONCLUSIONS	Among women under 36 years old , early follicular phase GnRH antagonist pretreatment in a fixed GnRH antagonist protocol results in a trend toward a higher number of retrieved oocytes but does not yield significantly higher pregnancy rates .

###25337871
OBJECTIVE	Because of the restrictions applied to the conduct of randomized clinical trials , the risks reported in their comparison of open and endovascular aneurysm repair ( EVAR ) of abdominal aortic aneurysms ( AAA ) may not be applicable to real-world vascular surgical practice .
OBJECTIVE	The magnitude of this deviation is indeterminate .
OBJECTIVE	To compare 30-day mortality from the recent Open Vs Endovascular Repair ( OVER ) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) and to assess temporal trends in perioperative mortality .
METHODS	We analyzed data from 21,115 patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January 1 , 2005 , and December 31 , 2011 , in the NSQIP database .
METHODS	We used 2 and t tests to compare perioperative mortality between groups .
METHODS	Logistic regression was used to analyze perioperative mortality , adjusting for age , sex , race , and comorbidities .
METHODS	The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP .
METHODS	Death within 30 days of surgery .
RESULTS	Perioperative mortality was 3.7 % ( 95 % CI , 3.2 % -4.3 % ) after open repair and 1.3 % ( 95 % CI , 1.2 % -1.5 % ) after EVAR .
RESULTS	There was a 70 % reduction in operative mortality after EVAR compared with open repair ( adjusted odds ratio [ aOR ] , 0.30 ; 95 % CI , 0.25-0 .38 ; P < .001 ) .
RESULTS	Mortality was significantly lower in men compared with women ( aOR , 0.73 ; 95 % CI , 0.57-0 .92 ; P = .009 ) .
RESULTS	Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair ( EVAR , 1.3 % vs 0.2 % ; open , 3.7 % vs 2.3 % ) .
RESULTS	There was an increase in the proportion of patients who received EVAR during the 7 years studied ( 65 % in 2005 and 80 % in 2011 ) .
RESULTS	There has been no significant decrease in perioperative mortality during these years ( P > .05 ) .
CONCLUSIONS	Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials .
CONCLUSIONS	We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair .
CONCLUSIONS	This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA .
CONCLUSIONS	There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques , devices , and proficiency .

###23732051
BACKGROUND	Oral flucloxacillin , either alone or in combination with phenoxymethylpenicillin , is a commonly prescribed antibiotic for the treatment of cellulitis , particularly in Ireland and the United Kingdom .
BACKGROUND	This study aims to establish the non-inferiority of oral monotherapy ( flucloxacillin alone ) to dual therapy ( flucloxacillin and phenoxymethylpenicillin ) for the outpatient treatment of cellulitis in adults .
METHODS	This study is a multicentre , randomised , double-blind , placebo-controlled trial of adults who present to the emergency department ( ED ) with cellulitis that is deemed treatable on an outpatient basis with oral antibiotics .
METHODS	After fulfilling specified inclusion and exclusion criteria , informed consent will be taken .
METHODS	Patients will be given a treatment pack containing 7 days of treatment with flucloxacillin 500 mg four times daily and placebo or flucloxacillin 500 mg four times daily and phenoxymethylpenicillin 500 mg four times daily .
METHODS	The primary outcome measure under study is the proportion of patients in each group in which there is greater than or equal to a 50 % reduction in the area of diameter of infection from the area measured at enrolment at the end-of-treatment visit ( 7 to 10 days ) .
METHODS	Secondary endpoints include a health-related quality of life measurement as rated by the SF-36 score and the Extremity Soft Tissue Infection Score ( not validated ) , compliance and adverse events .
METHODS	Patients will be followed up by telephone call at 3 days , end-of-treatment visit ( EOT ) at 7 to 10 days and test-of-cure ( TOC ) visit at 30 days .
METHODS	To achieve 90 % power , a sample size of 172 patients per treatment arm is needed .
METHODS	This assumes a treatment success rate of 85 % with oral flucloxacillin and phenoxymethylpenicillin , an equivalence threshold = 12.5 % and an = 0.025 .
METHODS	Non-inferiority will be assessed using a one-sided confidence interval on the difference of proportions between the two groups .
METHODS	Standard analysis including per-protocol and intention-to-treat will be performed .
CONCLUSIONS	This trial aims to establish the non-inferiority of flucloxacillin monotherapy to dual therapy in the treatment of uncomplicated cellulitis among ED patients .
CONCLUSIONS	In doing so , this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines .

###23323043
OBJECTIVE	The quality and radiation dose of different tube voltage sets for chest digital radiography ( DR ) were compared in a series of pediatric age groups .
METHODS	Forty-five hundred children aged 0-14 years ( yr ) were randomly divided into four groups according to the tube voltage protocols for chest DR : lower kilovoltage potential ( kVp ) ( A ) , intermediate kVp ( B ) , and higher kVp ( C ) groups , and the fixed high kVp group ( controls ) .
METHODS	The results were analyzed among five different age groups ( 0-1 yr , 1-3 yr , 3-7 yr , 7-11 yr and 11-14 yr ) .
METHODS	The dose area product ( DAP ) and visual grading analysis score ( VGAS ) were determined and compared by using one-way analysis of variance .
RESULTS	The mean DAP of protocol C was significantly lower as compared with protocols A , B and controls ( p < 0.05 ) .
RESULTS	DAP was higher in protocol A than the controls ( p < 0.001 ) , but it was not statistically significantly different between B and the controls ( p = 0.976 ) .
RESULTS	Mean VGAS was lower in the controls than all three protocols ( p < 0.001 for all ) .
RESULTS	Mean VGAS did not differ between protocols A and B ( p = 0.334 ) , but was lower in protocol C than A ( p = 0.008 ) and B ( p = 0.049 ) .
CONCLUSIONS	Protocol C ( higher kVp ) may help optimize the trade-off between radiation dose and image quality , and it may be acceptable for use in a pediatric age group from these results .

###7866602
OBJECTIVE	This study aimed to investigate the influence of vasoactive drugs , including a calcium channel blocker , nitroglycerine , and a beta-blocker , often used after coronary artery bypass grafting ( CABG ) .
OBJECTIVE	Measurements were taken using a new , completely implantable , mini-Doppler system .
OBJECTIVE	The probes were implanted during CABG , led outside through the thoracic wall , and removed 3 days after the operation by a simple pull .
RESULTS	The mean Doppler flow increased dramatically in the calcium channel blocker and the nitroglycerine groups ( P = 0.002 ) and decreased slightly in the beta-blocker group ( P = 0.015 ) .
RESULTS	Mean arterial pressure decreased significantly in all three groups .
RESULTS	Heart rate decreased in the beta-blocker group ( P = 0.002 ) .
RESULTS	Changes in the other hemodynamic variables measured were not significant ; there were no changes in the control group .
RESULTS	Doppler sonographic monitoring of bypass diameters did not show any changes .
CONCLUSIONS	This is the first study to measure the influence of vasoactive drugs directly and online after CABG .
CONCLUSIONS	From our experience of more than 40 implantations , we conclude that our method is easy to use and reliable and will help improve the therapeutic regimen for patients after CABG .

###9421122
BACKGROUND	This double-blind , randomized study evaluated the efficacy of dual and triple therapies including ranitidine for treatment of Helicobacter pylori infection .
METHODS	Dyspeptic patients ( n = 105 ) with a positive rapid urease test formed the intention-to-treat population ( ITT ) .
METHODS	All patients were assigned to 14 days treatment with ranitidine 300 mg b.i.d and clarithromycin 750 mg b.i.d. Group A ( n = 53 ) also received a placebo twice daily , while group B ( n = 52 ) received lymecycline 300 mg b.i.d. Treatment with ranitidine , 150 mg b.i.d , was continued for an additional 30 days .
METHODS	H. pylori infection was verified by culture .
METHODS	Twelve weeks after antibiotic treatment , H. pylori status was investigated by culture and 14C-urea breath test ( UBT ) .
METHODS	The per-protocol ( PP ) group consisted of 73 patients ( A , n = 38 ; B , n = 35 ) .
RESULTS	Cure rates were 87 % ( 95 % C.I. = 72 % to 94 % ) vs. 72 % ( 95 % C.I. = 58 % to 83 % ) in the ITT-group and 89 % ( 95 % C.I. = 73 % to 97 % ) vs. 87 % ( 95 % C.I. = 72 % to 96 % ) in the PP-population ( culture and UBT ) when triple and dual therapies were compared .
RESULTS	In all patients who were not cured , clarithromycin resistance of H. pylori was acquired .
RESULTS	Side effects were experienced by 54 % of patients .
CONCLUSIONS	The difference in efficacy between the two treatment regimens was not significant .
CONCLUSIONS	However , the cure rates in this study are comparable to combination treatments with omeprazole .
CONCLUSIONS	Treatment failures were due to acquired clarithromycin resistance .

###25141250
OBJECTIVE	To compare the safety and efficacy of U.S. Food and Drug Administration ( FDA ) - recommended doses of labetalol and nicardipine for hypertension ( HTN ) management in a subset of patients with renal dysfunction ( RD ) .
METHODS	Randomized , open label , multicenter prospective clinical trial .
METHODS	Thirteen United States tertiary care emergency departments .
METHODS	Subgroup analysis of the Evaluation of IV Cardene ( Nicardipine ) and Labetalol Use in the Emergency Department ( CLUE ) clinical trial .
METHODS	The subjects were 104 patients with RD ( i.e. , creatinine clearance < 75 mL/min ) who presented to the emergency department with a systolic blood pressure ( SBP ) 180 mmHg on 2 consecutive readings and for whom the emergency physician felt intravenous antihypertensive therapy was desirable .
METHODS	The FDA recommended doses of either labetalol or nicardipine for HTN management .
METHODS	The number of patients achieving the physician 's predefined target SBP range within 30 minutes of treatment .
RESULTS	Patients treated with nicardipine were within target range more often than those receiving labetalol ( 92 % vs. 78 % , P = 0.046 ) .
RESULTS	On 6 SBP measures , patients treated with nicardipine were more likely to achieve the target range on either 5 or all 6 readings than were patients treated with labetalol ( 46 % vs. 25 % , P = 0.024 ) .
RESULTS	Labetalol patients were more likely to require rescue medication ( 27 % vs. 17 % , P = 0.020 ) .
RESULTS	Adverse events thought to be related to either treatment group were not reported in the 30-minute active study period , and patients had slower heart rates at all time points after 5 minutes ( P < 0.01 ) .
CONCLUSIONS	In severe HTN with RD , nicardipine-treated patients are more likely to reach a target blood pressure range within 30 minutes than are patients receiving labetalol .
CONCLUSIONS	Within 30 minutes of administration , nicardipine is more efficacious than labetalol for acute blood pressure control in patients with RD. .

###24448262
OBJECTIVE	Mass drug administration ( MDA ) is part of the SAFE strategy for trachoma elimination .
OBJECTIVE	This study examined the effect of three annual MDAs on prevalence of trachoma among 13 longitudinal cohorts of Tanzanian children .
METHODS	Children younger than 10 years were assigned to cohorts based on age at baseline and followed annually for 3 years , with newborns assigned to new cohorts over time .
METHODS	Annual MDA consisted of topical tetracycline for children younger than 6 months and oral azithromycin for those 6 months and older .
METHODS	Follicular trachoma ( TF ) and Chlamydia trachomatis infection status were assessed annually before the next MDA .
METHODS	Prevalence and risk factors for TF and infection at each age were compared across cohorts .
RESULTS	At each survey , most age groups and cohorts had MDA coverage of more than 80 % and showed decreased TF prevalence after every MDA .
RESULTS	One cohort had consistently lower coverage , higher-than-expected TF and infection at ages 6 and 7 , and elevated risk of TF at age 7 relative to the preceding cohort in spite of receiving one additional MDA ( odds ratio 2.3 , 95 % confidence interval 1.0-5 .2 ) .
RESULTS	Cohorts aged 1 or older at baseline generally showed reductions in TF and infection after each MDA , whereas younger cohorts showed decreased infection but increased TF over time .
RESULTS	Successive cohorts of never-treated children younger than 1 year showed sequential TF and infection reductions with each MDA ( P < 0.001 ) .
CONCLUSIONS	Multiple MDAs significantly reduce trachoma prevalence and appear to increasingly protect children born into these communities .
CONCLUSIONS	The youngest children show declining/stable rates of infection but increasing rates of trachoma , which may reflect longer duration of clinical signs .

###9529556
BACKGROUND	Pruritus in HIV-1 + patients is common and increases with disease progression .
BACKGROUND	The causes of pruritus are numerous including xerosis , drug and photoeruptions , follicular and papular eruptions as well as infestations and infections by a wide range of organisms .
BACKGROUND	One other possible factor contributing to pruritus is the pattern of immune dysregulation .
BACKGROUND	With advancing HIV-1 disease there is Th1 to Th2 cytokine switching .
METHODS	After some positive results with prostaglandin inhibitors , we undertook a study in which we randomly placed patients on four different forms of therapy for their pruritus .
METHODS	The therapies included hydroxyzine with or without doxepin at night , pentoxifylline , indomethacin and topical moisturization with medium-strength topical steroids .
METHODS	All patients were evaluated for both subjective relief as well as side effects .
RESULTS	Patients placed on indomethacin obtained relief more consistently and more completely .
RESULTS	Patients on pentoxifylline had the fewest side effects of all oral therapies .
RESULTS	Patients on antihistamines with or without doxepin had the highest incidence of side effects , although more of these patients reported a greater degree of relief than patients on pentoxifylline .
RESULTS	All patients on oral therapy overall had greater relief than patients using topical steroids .
CONCLUSIONS	The systemic therapies which may modulate the pattern of immune dysregulation seen in HIV-1 disease may be beneficial in the pruritus seen in late-stage patients .

###22878383
OBJECTIVE	To evaluate demographic , clinical , and microbiological profile of eye donors and efficacy of 0.3 % gatifloxacin hydrochloride in microbial decontamination of donor corneas .
METHODS	About 513 donors and 1,026 corneas received at National Eye Bank of a tertiary care hospital during 1-year period were analyzed prospectively in this randomized clinical trial .
METHODS	The donor eyes were graded and treated with 5 % povidone-iodine , 0.4 % amikacin sulphate , and 0.3 % gatifloxacin hydrochloride .
METHODS	The parameters evaluated were death enucleation time ( DET ) , grading of donor corneas , microbiological profile of culture organisms , and their sensitivity to various antibiotics .
RESULTS	Mean DET was 6.295.7 hours .
RESULTS	Forty one percent eyes were optical grade corneas and the majority of donors ( 38.5 % ) had accidental deaths .
RESULTS	Good grade eyes were maximum with DET of < 1 hour and were comparable between 0-6 hours and 6-12 hours .
RESULTS	About 57.6 % ( 591/1026 ) eyes were culture positive ; most common organisms were Pseudomonas spp ( 53 % ) and Coagulase-negative Staphylococci ( 24 % ) .
RESULTS	Culture positivity reduced significantly after treatment with povidone iodine and amikacin ( P = 0.002 , right eye ; P = 0.004 ; left eye ) and decreased further with use of gatifloxacin ( P = 0.001 ) .
RESULTS	Pseudomonas ( 93 % ) , Coagulase-negative Staphylococci ( 96.3 % ) , Staphylococcus aureus ( 90.5 % ) , enterococci and gram-negative bacilli were sensitive to gatifloxacin .
RESULTS	Pseudomonas spp which were multidrug-resistant were sensitive to polymyxin-B .
CONCLUSIONS	Gatifloxacin hydrochloride in addition to amikacin sulphate is beneficial for donor eye decontamination .
CONCLUSIONS	Polymyxin-B may be used for multidrug-resistant Pseudomonas spp .

###17496414
OBJECTIVE	The purpose of the present study was to evaluate the differences in the sequence of administration of 5-fluorouracil ( 5-FU ) / leucovorin ( LV ) followed by irinotecan ( CPT-11 ) , or CPT-11 followed by 5-FU/LV in advanced colorectal cancer ( ACC ) .
METHODS	Chemotherapy-nave patients with ACC were allocated to the following treatment groups : group A , a bolus of 20 mg/m ( 2 ) LV and 425 mg/m ( 2 ) 5-FU for 5 days until progression/relapse , and upon progression treatment with weekly CPT-11 ( 100 mg/m ( 2 ) ) , and group B , CPT-11 followed at progression/relapse by 5-FU/LV at the same doses and schedules as in group A.
RESULTS	120 patients were randomized to receive one of the two treatment sequences and their pretreatment characteristics were equally balanced between treatment arms .
RESULTS	No statistically significant difference was found in the objective response rate to CPT-11 ( p = 0.45 ) ; partial response ( PR ) was 23.3 % for group A patients and 33.3 % for group B. Following documented progression and second line treatment there was a significant difference between the response rate in group A ( 23.3 % ) and group B where no patients were found to respond to second-line treatment with 5-FU/LV ( p = 0.024 ) .
RESULTS	The median overall survival was 42.0 weeks ( range , 36.6-47 .4 weeks ) for group A and 32.0 weeks ( range , 28.2-35 .8 weeks ) for group B.
RESULTS	The median time to progression for patients in group A following first-line 5-FU/LV was 18 weeks ( range , 10-36 weeks ) and 12 weeks ( range , 10-16 weeks ) for group B following first-line CPT-11 ( p = 0.0005 ) .
RESULTS	Toxicity , according to WHO , was similar between groups .
CONCLUSIONS	Treating patients with CPT-11 upon progression to 5-FU/LV treatment seems to be superior to the opposite sequence .
CONCLUSIONS	We used these treatments as sequential monotherapies ( at progression/relapse ) , and the best results are gained when 5-FU/LV is followed by CPT-11 at disease progression or relapse .

###17509947
OBJECTIVE	Few trials report event-adjudication procedures in detail .
OBJECTIVE	Using data from the ACTION ( A Coronary disease Trial Investigating Outcome with Nifedipine GITS ) study , we compared the impact on event-rates of an adjudication strategy based on systematic screening of all reported serious adverse events ( SAEs ) with a strategy based on investigator diagnoses .
OBJECTIVE	The final diagnosis was always made by a critical events committee ( CEC ) using standard criteria .
METHODS	ACTION randomized 7665 patients with stable angina to either nifedipine or placebo .
METHODS	Pre-specified events included acute or procedural myocardial infarction ( MI ) , refractory angina , heart failure and debilitating stroke .
METHODS	Clinically related SAEs including in-hospital procedures were combined into episodes independent from the investigator diagnoses entered on SAE reports .
METHODS	All fatal episodes and those episodes suggestive of pre-specified events were adjudicated by the CEC .
RESULTS	During follow-up , 17,081 episodes were reported in 5312 patients .
RESULTS	The SAE descriptions ruled out the occurrence of a pre-specified event in 28 % .
RESULTS	The remaining 72 % were adjudicated by the CEC and 616 cases of MI , 361 of refractory angina , 275 of heart failure and 190 of debilitating stroke were diagnosed ( total = 1442 ) .
RESULTS	Had adjudication by the CEC been limited to the 3924 episodes ( 2397 patients ) that were fatal or for which the investigator had reported any of the diagnoses mentioned , 98 cases of MI , 35 of refractory angina , 81 of heart failure and 14 of debilitating stroke would have been missed ( total = 228 ) .
CONCLUSIONS	Both the diagnostic criteria used and the adjudication process determine event-rates and conclusions about treatment effects in clinical trials .
CONCLUSIONS	Published trial reports should always state if event-adjudication was independent of the diagnoses of investigators , and if all events of interest were adjudicated or only the first one .

###12422155
OBJECTIVE	The aim of this study was to evaluate the effects of 2 different right atrial electrode coil lengths on energy and voltage requirements for transvenous atrial cardioversion .
METHODS	Twenty-six patients ( mean age 61 + / - 11 years ) with chronic persistent atrial fibrillation ( AF ) ( mean duration 11 + / - 10 months ) underwent transvenous cardioversion .
METHODS	A 6F catheter with a 5.5-cm coil was positioned in the coronary sinus .
METHODS	Another catheter with either a 5.5-cm or an 8-cm coil was positioned along the lateral wall of the right atrium , according to a randomized allocation .
METHODS	R wave-synchronized biphasic shocks were delivered according to a step-up protocol .
METHODS	After cardioversion of baseline AF , AF was reinduced , the right atrial catheter was substituted , and cardioversion was repeated with the alternative right atrial coil .
RESULTS	Successful cardioversion was obtained in all of the patients .
RESULTS	Leading edge voltage of effective shocks was significantly lower when catheters with an 8-cm coil in right atrium were used compared with the alternative 5-cm coil catheters ( 301 + / - 80 volts vs 340 + / - 78 volts , P < .001 ) , and delivered energy ( 6.75 + / - 4.25 joules vs 7.86 + / - 4.29 joules , P = .043 ) and shock impedance ( 60 + / - 9 ohm vs 66 + / - 10 ohm , P < .001 ) were lower .
RESULTS	Moreover , shock-induced discomfort , evaluated by assessment of pain score , was reduced ( 3.69 + / - 1.09 vs 4.12 + / - 0.99 , P = .035 ) .
CONCLUSIONS	The use of a longer right atrial coil results in lower shock impedance , lower energy and voltage requirements , and lower discomfort during transvenous atrial cardioversion .
CONCLUSIONS	The results of the current study are of value either for transvenous internal cardioversion of chronic persistent AF or for implantable atrial defibrillators .

###19440025
OBJECTIVE	This study was undertaken to compare the results of laser ( Ho : YAG ) and pneumatic ( ballistic ) intracorporeal lithotripsy for ureteric calculi in terms of efficacy , safety and complications .
METHODS	55 patients having ureteric calculus were randomly allocated into pneumatic lithotripsy ( PL ) and laser lithotripsy ( LL ) groups .
METHODS	Swiss lithoclast was used for PL ( 3 atm pressure and 12 Hz frequency ) and the VersaPulse PowerSuite was used for LL .
METHODS	Appropriate statistical tests were applied .
RESULTS	30 patients ( 34 stones ) were treated with LL and 25 patients ( 25 stones ) with PL .
RESULTS	Both groups were comparable in profile .
RESULTS	Mean lithotripsy time was 24.03 + / - 9.51 min in the LL group and 19.80 + / - 4.44 min in the PL group ( p = 0.027 ) .
RESULTS	The immediate stone clearance rate was higher in the LL group ( p = 0.001 ) , but it was comparable at 4 weeks ( p = 0.097 ) .
RESULTS	Stone migration occurred in 16 % of cases in the PL group .
RESULTS	No major complication was observed in either group .
CONCLUSIONS	We conclude that both laser and pneumatic energies are effective and safe for intracorporeal lithotripsy .
CONCLUSIONS	Laser lithotripsy takes more time but provides earlier stone-free status .

###21345850
OBJECTIVE	Major guidelines recommend lowering systolic blood pressure ( SBP ) to < 140 mmHg in all hypertensives , but evidence is missing whether this is beneficial in ( i ) uncomplicated hypertensives , ( ii ) grade 1 hypertensives , and ( iii ) elderly hypertensives .
OBJECTIVE	Providing this missing evidence is important to justify efforts and costs of aggressive therapy in all hypertensives .
RESULTS	Felodipine Event Reduction ( FEVER ) was a double-blind , randomized trial on 9711 Chinese hypertensives , in whom cardiovascular outcomes were significantly reduced by more intense therapy ( low-dose hydrochlorothiazide and low-dose felodipine ) achieving a mean of 138 mmHg SBP compared with less-intense therapy ( low-dose hydrochlorothiazide and placebo ) achieving a mean of 142 mmHg .
RESULTS	FEVER included older and younger patients , and patients with and without diabetes or cardiovascular disease .
RESULTS	In the analyses here reported , Cox regression models assessed outcome differences between more and less-intense treatments in groups of patients with different baseline characteristics .
RESULTS	Significant reductions in stroke were found in uncomplicated hypertensives ( -39 % , P = 0.002 ) , in hypertensives with randomization SBP < 153 mmHg ( -29 % , P = 0.03 ) , and in elderly hypertensives ( -44 % , P < 0.001 ) , when their SBP was lowered by more intense treatment .
RESULTS	Significant reductions ( between -29 and -47 % , P = 0.02 to < 0.001 ) were also found in all cardiovascular events and all deaths .
RESULTS	Achieving mean SBP values < 140 mmHg by adding a small dose of a generic drug prevented 2.1 ( uncomplicated hypertensives ) and 5.2 ( elderly ) cardiovascular events every 100 patients treated for 3.3 years .
CONCLUSIONS	These analyses provide strong support , missing so far , to guidelines recommending goal SBP < 140 mmHg in uncomplicated hypertensives , individuals with moderately elevated BP and elderly hypertensives .

###20659072
BACKGROUND	A randomized controlled trial of screening , brief intervention , and referral to treatment ( SBIRT ) among at-risk ( based on average number of drinks per week and drinks per drinking day ) and dependent drinkers was conducted in an emergency department ( ED ) among 446 patients 18 and older in Sosnowiec , Poland .
METHODS	Patients were recruited over a 23-week period ( 4:00 pm to 12:00 midnight ) and randomized to 1 of 3 conditions : screened-only ( n = 147 ) , assessed ( n = 152 ) , and intervention ( n = 147 ) .
METHODS	Patients in the assessed and intervention conditions were blindly reassessed via a telephone interview at 3 months , and all 3 groups were assessed at 12 months ( screened-only = 92 , assessed = 99 , and intervention = 87 ) .
RESULTS	No difference was found across the 3 conditions in at-risk drinking at 12 months , as the primary outcome variable , or in decrease in the number of drinks per drinking day , with all 3 groups showing a significant reduction in both .
RESULTS	Significant declines between baseline and 12 months in secondary outcomes of the RAPS4 , number of drinking days per week , and the maximum number of drinks on an occasion were seen only for the intervention condition , and in negative consequences for both the assessment and intervention conditions .
CONCLUSIONS	Data suggest that improvements in drinking outcomes found in the assessment condition were not because of assessment reactivity , with both the screened and intervention conditions demonstrating greater ( although nonsignificant ) improvement than the assessed condition .
CONCLUSIONS	Only those in the intervention condition showed significant improvement in all outcome variables from baseline to 12-month follow-up .
CONCLUSIONS	Although group by time interaction effects were not found to be significant , these findings suggest that declines in drinking measures for those receiving a brief intervention can be maintained at long-term follow-up .

###23052571
BACKGROUND	Japanese researchers have recently conducted studies using near-infrared spectroscopy ( NIRS ) to help diagnose psychiatric disorders based on changes in brain activity .
BACKGROUND	However , the influence of psychotropic drugs on NIRS measurements has not been clarified .
OBJECTIVE	To assess the effects of sedative antidepressants on prefrontal cortex activity in healthy subjects using NIRS in a double-blinded , placebo-controlled , crossover trial .
METHODS	Nineteen healthy males received nocturnal doses of mirtazapine 15mg , trazodone 25mg , or placebo for eight consecutive days in rotation , with a washout period of more than 1week between each rotation .
METHODS	Subjects performed a verbal fluency task during NIRS on a total of seven occasions during the study period : more than a week prior to receiving the first dose of the first medication ; and on days 2 and 9 of each rotation .
METHODS	The number of words correctly generated during the task ( behavioral performance ) was also recorded .
METHODS	Stanford Sleepiness Scale ( SSS ) scores were determined each day .
RESULTS	Mirtazapine 15mg significantly increased oxyhemoglobin ( oxy-Hb ) concentration change in NIRS on day 9 , compared to trazodone 25mg and placebo .
RESULTS	Mirtazapine 15mg significantly increased SSS on day 2 , compared to the other conditions .
RESULTS	No significant differences in behavioral performance were observed .
CONCLUSIONS	Administration of mirtazapine for eight consecutive days affected oxy-Hb changes on NIRS .
CONCLUSIONS	This result indicates that researchers should consider how certain types of antidepressant could influence brain function when the brain activity of patients with psychiatric disorders is assessed .

###23013802
BACKGROUND	Severe TBI , defined as a Glasgow Coma Scale8 , increases intracranial pressure and activates the sympathetic nervous system .
BACKGROUND	Sympathetic hyperactivity after TBI manifests as catecholamine excess , hypertension , abnormal heart rate variability , and agitation , and is associated with poor neuropsychological outcome .
BACKGROUND	Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow , brain edema , and agitation .
BACKGROUND	However , there is no prospective randomized evidence available demonstrating the feasibility , outcome benefits , and safety for adrenergic blockade after TBI .
METHODS	The DASH after TBI study is an actively accruing , single-center , randomized , double-blinded , placebo-controlled , two-arm trial , where one group receives centrally acting sympatholytic drugs , propranolol ( 1mg intravenously every 6h for 7days ) and clonidine ( 0.1 mg per tube every 12h for 7days ) , and the other group , double placebo , within 48h of severe TBI .
METHODS	The study uses a weighted adaptive minimization randomization with categories of age and Marshall head CT classification .
METHODS	Feasibility will be assessed by ability to provide a neuroradiology read for randomization , by treatment contamination , and by treatment compliance .
METHODS	The primary endpoint is reduction in plasma norepinephrine level as measured on day 8 .
METHODS	Secondary endpoints include comprehensive plasma and urine catecholamine levels , heart rate variability , arrhythmia occurrence , infections , agitation measures using the Richmond Agitation-Sedation Scale and Agitated Behavior scale , medication use ( anti-hypertensive , sedative , analgesic , and antipsychotic ) , coma-free days , ventilator-free days , length of stay , and mortality .
METHODS	Neuropsychological outcomes will be measured at hospital discharge and at 3 and 12months .
METHODS	The domains tested will include global executive function , memory , processing speed , visual-spatial , and behavior .
METHODS	Other assessments include the Extended Glasgow Outcome Scale and Quality of Life after Brain Injury scale .
METHODS	Safety parameters evaluated will include cardiac complications .
CONCLUSIONS	The DASH After TBI Study is the first randomized , double-blinded , placebo-controlled trial powered to determine feasibility and investigate safety and outcomes associated with adrenergic blockade in patients with severe TBI .
CONCLUSIONS	If the study results in positive trends , this could provide pilot evidence for a larger multicenter randomized clinical trial .
CONCLUSIONS	If there is no effect of therapy , this trial would still provide a robust prospective description of sympathetic hyperactivity after TBI .
BACKGROUND	ClinicalTrials.gov NCT01322048 .

###17449194
OBJECTIVE	To evaluate the long-term prognostic impact of plasma Epstein-Barr virus ( EBV ) DNA concentration measured by real-time quantitative polymerase chain reaction ( RTQ-PCR ) in nasopharyngeal carcinoma ( NPC ) patients receiving concurrent chemoradiotherapy ( CCRT ) .
METHODS	Epstein-Barr virus DNA was retrospectively measured from stock plasma of 152 biopsy-proven NPC patients with Stage II-IV ( M0 ) disease with a RTQ-PCR using the minor groove binder-probe .
METHODS	All patients received CCRT with a median follow-up of 78 months .
METHODS	We divided patients into three subgroups : ( 1 ) low pretreatment EBV DNA ( < 1,500 copies/mL ) and undetectable posttreatment EBV DNA ( pre-L/post-U ) , ( 2 ) high pretreatment EBV DNA ( > or = 1,500 copies/mL ) and undetectable posttreatment EBV DNA ( pre-H/post-U ) , and ( 3 ) low or high pretreatment EBV DNA and detectable posttreatment EBV DNA ( pre-L or H/post-D ) for prognostic analyses .
RESULTS	Epstein-Barr virus DNA ( median concentration , 573 copies/mL ; interquartile range , 197-3 ,074 ) was detected in the pretreatment plasma of 94.1 % ( 143/152 ) of patients .
RESULTS	After treatment , plasma EBV DNA decreased or remained 0 for all patients and was detectable in 31 patients ( 20.4 % ) with a median concentration 0 copy/mL ( interquartile range , 0-0 ) .
RESULTS	The 5-year overall survival rates of the pre-L/post-U , pre-H/post-U , and pre-L or H/post-D subgroups were 87.2 % , 71.0 % , and 38.7 % , respectively ( p < 0.0001 ) .
RESULTS	The relapse-free survival showed similar results with corresponding rates of 85.6 % , 75.9 % , and 26.9 % , respectively ( p < 0.0001 ) .
RESULTS	Multivariate Cox analysis confirmed the superior effects of plasma EBV DNA compared to other clinical parameters in prognosis prediction .
CONCLUSIONS	Plasma EBV DNA is the most valuable prognostic factor for NPC .
CONCLUSIONS	More chemotherapy should be considered for patients with persistently detectable EBV DNA after CCRT .

###23592567
BACKGROUND	The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent ( ZoMaxx ( ) ) when compared with a paclitaxel-eluting coronary stent ( Taxus ( ) Express ( 2 ) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis .
BACKGROUND	Angiographic analysis at the primary endpoint of 9 months has been reported previously .
BACKGROUND	The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years .
RESULTS	In the ZOMAXX I trial , 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe , Australia , and New Zealand .
RESULTS	The two groups were generally well matched with respect to both clinical and lesional characteristics , including the incidence of diabetes ( ZoMaxx 22 % vs. Taxus 26 % ; P = 0.29 ) , reference vessel diameter ( ZoMaxx 2.79 0.43 mm vs. Taxus 2.81 0.46 mm ; P = 0.65 ) , and lesion length ( ZoMaxx 14.9 5.7 mm vs. Taxus 14.6 5.5 ; P = 0.61 ) .
RESULTS	Through 5 years of follow-up , a total of 21 patients had died , six patients had withdrawn , nine had been lost to follow-up , and 13 missed their 5-year visit , leaving a total of 347 patients for analysis ( 169 ZoMaxx and 178 Taxus ) .
RESULTS	At the 5-year time point , there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization ( TLR ; ZoMaxx 10.6 % vs. Taxus 7.1 % ; P = 0.29 ) , Q-wave myocardial infarction ( ZoMaxx 1.5 % vs. Taxus 1.0 % ; P = 0.99 ) , definite/probable stent thrombosis ( ZoMaxx 1.5 % vs. Taxus 3.0 % ; P = 0.34 ) , and cardiac death ( ZoMaxx 3.0 % vs. Taxus 1.0 % ; P = 0.28 ) .
CONCLUSIONS	After 5 years , the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance .
CONCLUSIONS	However , the nominally higher rate of ischemia-driven TLR ( 10.6 vs. 7.1 % ) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus .
CONCLUSIONS	2013 Wiley Periodicals , Inc. .

###19576082
OBJECTIVE	To explore the effect of adriamycin , bleomycin , vincristine and dacarbazinum ( ABVD ) chemotherapy scheme executed at day 1 and day 8 for primary Hodgkin 's lymphomas ( HL ) .
METHODS	62 patients with primary HL in stages II - IV treated in our department from October 2005 to October 2006 were divided into group A and B at random with 31 patients in each group .
METHODS	The patients in group A received ABVD chemotherapy scheme executed at day 1 and day 8 for 6 - 8 cycles .
METHODS	The patients in group B received ABVD chemotherapy scheme executed at day 1 and day 15 for 6 - 8 cycles .
METHODS	The patients of the groups received radiotherapy by the same doctor after chemotherapy according to the patients condition and the radiotherapy regimens were not affected by the grouping .
RESULTS	The complete remission rate ( CR ) in group A after chemotherapy was 90.3 % ( 28/31 ) ; the one-year and two-year disease free survival ( DFS ) rates were 87.1 % ( 27/31 ) and 80.0 % ( 20/25 ) respectively .
RESULTS	The CR rate in group B after chemotherapy was 83.9 % ( 26/31 ) ; the one-year and two-year DFS rates were 80.6 % ( 25/31 ) and 72.0 % ( 18/25 ) respectively .
RESULTS	The discrepancy of CR rates and the one-year and two-year DFS rates between the two groups was not significant ( P > 0.05 ) .
RESULTS	The incidences of therapeutic side effects such as myocardial ischemia grade III - IV liver function impairment , pulmonary fibrosis and serious marrow inhibition between the two groups were not significant too ( P > 0.05 ) .
RESULTS	Average chemotherapy period for the patients in group A was 159 days ; it was 69 days shorter than that in group B.
CONCLUSIONS	The CR rate , 1-year DFS rate and 2-year DFS rate of ABVD chemotherapy scheme executed at day 1 and 8 are similar to those of ABVD chemotherapy scheme executed at day 1 and 15 for primary HL in stages II - IV .
CONCLUSIONS	The side-effects of chemotherapy between group A and B are similar too .
CONCLUSIONS	The chemotherapy period in group A is shortened significantly .

###12860586
BACKGROUND	The value of the `` test-and-treat '' strategy in the approach to dyspepsia has been evaluated only in a few secondary care studies .
BACKGROUND	Most patients with dyspepsia , however , are treated by their primary care physician .
BACKGROUND	This study evaluated the test-and-treat strategy in primary care .
METHODS	Patients consulting their general practitioners for dyspepsia were randomized to either direct open-access endoscopy with Helicobacter pylori testing or a test-and-treat strategy by H pylori serology .
METHODS	In the 12-month follow-up period , any additional treatment or referral for investigations was left at the discretion of the general practitioner .
METHODS	At the end of the study , data were collected concerning the number of endoscopies , changes in symptom severity and quality of life , patient satisfaction , and the use of medical resources .
RESULTS	Two hundred seventy patients were enrolled ( 129 who received endoscopy and 141 in the test-and-treat group ) .
RESULTS	The prevalence of H pylori infection was 38.3 % and 37.2 % in the test-and-treat and endoscopy groups , respectively .
RESULTS	In the test-and-treat group , 46 patients ( 33 % ) were referred for endoscopy during follow-up .
RESULTS	Improvement in symptom severity , quality of life , and patient satisfaction was comparable in both groups .
RESULTS	Patients in the test-and-treat group paid more dyspepsia-related visits to their general practitioner ( P = .005 ) .
RESULTS	Patients in the endoscopy group were more often prescribed proton pump inhibitors ( P = .007 ) , whereas patients in the test-and-treat group were more often prescribed prokinetic drugs ( P = .005 ) .
CONCLUSIONS	The test-and-treat strategy proved to be as effective and safe as prompt endoscopy .
CONCLUSIONS	Only a minority of patients were referred for endoscopy after the test-and-treat approach .

###18833509
OBJECTIVE	For surveillance of Barrett 's esophagus random stepwise four-quadrant biopsy ( 4QB ) is recommended for detecting macroscopically occult neoplasias .
OBJECTIVE	Thorough performance of the systematic protocol is commonly hampered by poor visibility due to oozing from biopsy sites .
OBJECTIVE	Topical application of dilute epinephrine may prevent bleeding by vasoconstriction of superficial microvessels and might therefore enable `` dry biopsy '' sampling .
OBJECTIVE	The aim of this study was to examine the safety and efficacy of spraying dilute epinephrine for optimal 4QB mapping of Barrett 's esophagus .
METHODS	In this prospective , double-blind trial 40 patients with known long segment Barrett 's esophagus were randomly allocated to undergo spraying with either dilute epinephrine ( 1 : 20 000 ) ( epinephrine group ; n = 20 ) or saline ( control group ; n = 20 ) before 4QB sampling .
METHODS	During endoscopies patients received continuous monitoring of vital parameters .
METHODS	Endoscopists blinded to randomization assessed visibility scores during biopsy sampling .
METHODS	Additionally , electronically stored images of the Barrett 's esophagus segment after 4QB sampling were evaluated by blinded assessors .
RESULTS	The mean length of Barrett 's segments was 5.5 + / - 1.8 cm and the mean number of 4QBs was 12.5 + / - 3.6 with no statistically significant differences between control and epinephrine groups .
RESULTS	Epinephrine spraying did not affect patients ' vital parameters .
RESULTS	Visualization ratings by endoscopists on site and by the assessors of the stored images were significantly better in the epinephrine compared with the control group ( P < 0.05 ) .
RESULTS	Moreover , epinephrine spraying reduced the time for 4QB sampling ( P = 0.015 ) and the mean number of saline flushes needed to maintain visibility ( P = 0.0003 ) .
CONCLUSIONS	The novel `` dry biopsy '' technique with spraying of dilute epinephrine is safe , and facilitates thorough performance of systematic 4QB mapping of Barrett 's esophagus by improvement of visibility .

###23789889
BACKGROUND	The threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value .
BACKGROUND	We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia .
METHODS	We randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented insulin-pump therapy with or without the threshold-suspend feature for 3 months .
METHODS	The primary safety outcome was the change in the glycated hemoglobin level .
METHODS	The primary efficacy outcome was the area under the curve ( AUC ) for nocturnal hypoglycemic events .
METHODS	Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values .
RESULTS	A total of 247 patients were randomly assigned to receive sensor-augmented insulin-pump therapy with the threshold-suspend feature ( threshold-suspend group , 121 patients ) or standard sensor-augmented insulin-pump therapy ( control group , 126 patients ) .
RESULTS	The changes in glycated hemoglobin values were similar in the two groups .
RESULTS	The mean AUC for nocturnal hypoglycemic events was 37.5 % lower in the threshold-suspend group than in the control group ( 980 1200 mg per deciliter [ 54.4 66.6 mmol per liter ] minutes vs. 1568 1995 mg per deciliter [ 87.0 110.7 mmol per liter ] minutes , P < 0.001 ) .
RESULTS	Nocturnal hypoglycemic events occurred 31.8 % less frequently in the threshold-suspend group than in the control group ( 1.5 1.0 vs. 2.2 1.3 per patient-week , P < 0.001 ) .
RESULTS	The percentages of nocturnal sensor glucose values of less than 50 mg per deciliter ( 2.8 mmol per liter ) , 50 to less than 60 mg per deciliter ( 3.3 mmol per liter ) , and 60 to less than 70 mg per deciliter ( 3.9 mmol per liter ) were significantly reduced in the threshold-suspend group ( P < 0.001 for each range ) .
RESULTS	After 1438 instances at night in which the pump was stopped for 2 hours , the mean sensor glucose value was 92.6 40.7 mg per deciliter ( 5.1 2.3 mmol per liter ) .
RESULTS	Four patients ( all in the control group ) had a severe hypoglycemic event ; no patients had diabetic ketoacidosis .
CONCLUSIONS	This study showed that over a 3-month period the use of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia , without increasing glycated hemoglobin values .
CONCLUSIONS	( Funded by Medtronic MiniMed ; ASPIRE ClinicalTrials.gov number , NCT01497938 . )

###21733566
OBJECTIVE	The aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response .
METHODS	Randomised open-label phase IIa study in women with platinum-resistant or - refractory epithelial ovarian cancer .
METHODS	Catumaxomab ( 6-hour intraperitoneal infusion on days 0 , 3 , 7 and 10 ) was administered at a low ( 10 , 10 , 10 and 10 g ) or high dose ( 10 , 20 , 50 and 100 g ) .
METHODS	Responders were patients with either a complete ( CR ) or partial ( PR ) response .
RESULTS	Forty-five patients were randomised to receive either low dose ( 23 ) or high dose ( 22 ) .
RESULTS	There were no responders in the low-dose versus one patient ( 5 % ) in the high-dose group with a PR .
RESULTS	In the low-dose group , two patients ( 9 % ) had stable disease compared with five patients ( 23 % ) in the high-dose group .
RESULTS	Catumaxomab was well tolerated and there was no difference between the dose groups in the incidence of treatment-induced adverse events , the most common of which were gastrointestinal and injection-site reactions .
CONCLUSIONS	Catumaxomab had modest activity in platinum-resistant ovarian cancer .
CONCLUSIONS	The high-dose regimen was associated with a slightly better therapeutic index than the low dose regimen .

###21939972
BACKGROUND	The incidence of posttraumatic acute lung injury is high and may result in increased mortality .
BACKGROUND	Changes in the body position are additional measures to improve pulmonary gas exchange and to prevent pulmonary complications .
BACKGROUND	We investigated the effect of a continuous lateral rotational therapy ( CLRT ) on the inflammatory response in patients with posttraumatic lung failure .
METHODS	After admission to the intensive care unit ( ICU ) and after randomisation , 13 patients were placed in a special motor-driven bed and CLRT was performed for 5 days .
METHODS	In the control group ( n = 14 ) , patients were positioned conventionally .
METHODS	Samples from blood and from broncho-alveolar lavage fluid ( BAL ) were collected in both groups before study began and on day 5 .
METHODS	The levels of cytokines ( Tumour Necrosis Factor , Interleukin 6 , Interleukin 8 or Intercellular Adhesion Molecule-1 ) were assessed and haemodynamic , pulmonary , and laboratory values were documented .
RESULTS	On day 5 , no significant differences were found in cytokine levels between groups , but a significant decrease in IL-8 ( p < 0.01 ) and TNF - ( p < 0.05 ) serum levels and an increase in IL-8 BAL levels was found in the CLRT-group , but not for conventionally managed patients .
RESULTS	In general cytokine BAL levels tended to be increased in both groups , but more pronounced during CLRT .
RESULTS	Daily assessment of the severity of disease ( SAPS-II , SOFA ) was significantly reduced in the study group on days 2-4 ( p < 0.05 ) in comparison to control group .
CONCLUSIONS	CLRT may attenuate the inflammatory response to posttraumatic acute lung injury .
CONCLUSIONS	The exact mechanism of such an effect is unknown .

###15183553
OBJECTIVE	To determine whether a distance-learning programme on LUTS provided to the general practitioner affected patient self-management .
METHODS	A randomised trial was performed to examine the effects of the distance-learning programme ( an educational package for the GP and a patient information leaflet ) compared with written guidelines on LUTS mailed to the GP .
METHODS	In 63 general practices ( 32 intervention and 31 control ) across the Netherlands all patients older than 50 years presenting LUTS for the first time were invited to participate .
METHODS	Main outcome measures were patient evaluation of quality of care received and perceptions of enablement .
RESULTS	A total of 151 patients was included .
RESULTS	The intervention increased patient enablement regarding maintenance of independence ( OR = 3.14 ) and coping with illness ( OR = 2.21 ) .
RESULTS	Overall enablement scores were not changed .
RESULTS	Patients in the intervention group had more positive evaluations of general practice care received ( OR = 2.28 to 3.95 ) .
RESULTS	An explorative analysis suggested that the effects of the intervention were mediated in particular by handing out of patient information leaflets .
CONCLUSIONS	A distance-learning programme on LUTS for general practitioners had positive effects on patient self-management .
CONCLUSIONS	Handing out leaflets appeared to be a crucial mediating factor .

###16239861
OBJECTIVE	To compare the effectiveness of group cognitive-behavioral therapy ( GCBT ) and of sertraline in treatment-nave children and adolescents with obsessive-compulsive disorder .
METHODS	Between 2000 and 2002 , 40 subjects between 9 and 17 years old were randomized to receive GCBT ( n = 20 ) or sertraline ( n = 20 ) .
METHODS	GCBT consisted of a manual-based 12-week cognitive-behavioral protocol adapted for groups , and treatment with sertraline involved medication intake for 12 weeks .
METHODS	Subjects were assessed before , during , and after treatment ( at 1 , 3 , 6 , and 9 months after treatment conclusion ) .
METHODS	Primary outcome measure was the Children 's Yale-Brown Obsessive-Compulsive Scale .
METHODS	Repeated-measures analyses of variance were done .
RESULTS	Both GCBT and sertraline conditions had significant improvement in obsessive-compulsive disorder symptoms as measured by the Children 's Yale-Brown Obsessive-Compulsive Scale after 12 weeks of treatment .
RESULTS	After the 9-month follow-up period , subjects in the GCBT condition had a significantly lower rate of symptom relapse than those in the sertraline group .
CONCLUSIONS	The treatment with GCBT may be effective in decreasing obsessive-compulsive symptoms in childhood obsessive-compulsive disorder and should be considered as an alternative to either individual cognitive-behavioral therapy or a medication , such as sertraline .
CONCLUSIONS	Results support the effectiveness and the maintenance of gains of GCBT in the treatment of youngsters with obsessive-compulsive disorder .

###23930726
BACKGROUND	The common cold is responsible for the largest proportion of school and work absenteeism and is a huge economic burden .
BACKGROUND	None of the currently available interventions is clearly effective for prevention or treatment .
OBJECTIVE	To assess the efficacy of 15-mg chelated zinc ( zinc bis-glycinate ) given once a day for 3 months during the winter season to healthy school children aged 8-13 years to prevent symptoms of the common cold .
METHODS	In a double-blind randomized controlled trial , zinc bis-glycinate 15 mg or matching placebo once a day for 3 months was administered to healthy school children aged 8-13 years .
METHODS	Primary outcomes were any symptom of cold ( fever , cough , rhinorrhoea ) during the study period , and secondary outcomes were vomiting , diarrhoea , use of antibiotics , school absence for any reason , school absence because of a cold and duration of all symptoms .
RESULTS	Of 50 children in each group , 42 ( 84 % ) in the zinc group and 41 ( 82 % ) in the placebo group ( P = 1.00 ) developed at least one symptom of a cold .
RESULTS	There was no difference in the incidence of fever , cough , rhinorrhoea , school absence and school absence related to the common cold compared with children in the placebo group .
RESULTS	However , duration of cough [ median ( IQR ) 1.0 ( 0.0-6 .0 ) vs 6.0 ( 0.0-13 .3 ) days ] , rhinorrhoea [ median ( IQR ) 2.0 ( 0.0-7 .0 ) vs 5.5 ( 1.0-15 .3 ) days ] and the frequency of having two or more symptoms of the common cold [ median ( IQR ) 0.0 ( 0.0-1 .0 ) vs 1.0 ( 0.0-5 .3 ) days ] were reduced significantly in the intervention group ( P < 0.01 ) .
CONCLUSIONS	Zinc bis-glycinate given in a dose of 15 mg once a day for 3 months failed to reduce the incidence of the common cold in 8 to 13-year-old school children , but decreased the number of days on which children suffered from cough , rhinorrhoea and the likelihood of having two or more symptoms of the common cold .

###15690654
OBJECTIVE	Functional disturbances are common after anterior resection for rectal cancer .
OBJECTIVE	This study was designed to compare functional and physiologic outcome after low anterior resection and total mesorectal excision with a colonic J-pouch or a side-to-end anastomosis .
METHODS	Functional and physiologic variables were analyzed in patients randomized to a J-pouch ( n = 36 ) or side-to-end anastomosis ( n = 35 ) .
METHODS	Postoperative functional outcome was investigated with questionnaires .
METHODS	Anorectal manometry was performed preoperatively and at six months , one year , and two years postoperatively .
RESULTS	There was no statistical difference in functional outcome between groups at two years .
RESULTS	Maximum neorectal volume increased in both groups but was approximately 40 percent greater at two years in pouches compared with the side-to-end anastomosis .
RESULTS	Anal sphincter pressures volumes were halved postoperatively and did not recover during follow-up of two years .
RESULTS	Male gender , low anastomotic level , pelvic sepsis , and the postoperative decrease of sphincter pressures were independent factors for more incontinence symptoms .
CONCLUSIONS	Colonic J-pouch and side-to-end anastomosis gives comparable functional results two years after low anterior resection .
CONCLUSIONS	Neorectal volume had no detectable influence on function .
CONCLUSIONS	There was a pronounced and sustained postoperative decrease in sphincter pressures .

###19845926
OBJECTIVE	To compare the incidence of gastro-oesophageal reflux ( GOR ) during anaesthesia in the kitten when using a laryngeal mask airway ( LMA ) or an endotracheal tube ( ET ) .
METHODS	Prospective randomized cross-over experimental study .
METHODS	Forty Domestic Short Hair laboratory cats , 19 females and 21 males , aged 12-15 weeks and weighing 0.57-1 .73 kg ( mean 1.13 + / - SD 0.26 ) .
METHODS	Kittens were anaesthetized twice , once using the LMA and once the ET .
METHODS	Following induction of anaesthesia with isoflurane in an anaesthetic chamber and intubation of the trachea with the ET or placement of the LMA , a pH-electrode was introduced into the lower oesophagus .
METHODS	Monitoring of the oesophageal pH was performed for 45 minutes while anaesthesia was maintained with isoflurane .
METHODS	At the end of the experiment , gastric pH was measured .
METHODS	Kittens that had GOR during the experiment were treated with sucralfate , cisapride and ranitidine for 15 days .
METHODS	Results Oesophageal pH was 6.51 + / - 0.76 and gastric pH was 1.54 + / - 0.59 .
METHODS	GOR was observed in nine kittens when the ET was used , and in 20 kittens when the LMA was used , the difference being significant ( p = 0.013 ) .
METHODS	The refluxate nearly always was acidic , being alkaline in only one kitten .
METHODS	Most of the GOR episodes occurred shortly after induction of anaesthesia and the oesophageal pH remained below 4.0 until the end of the experiment .
METHODS	No regurgitation was observed .
CONCLUSIONS	The use of the LMA is associated with an increased incidence of GOR during anaesthesia in the kitten , which is not detected by observation .
CONCLUSIONS	That this may have occurred should be considered if the kitten demonstrates signs of oesophagitis in the postoperative period .

###21300931
OBJECTIVE	The 2000 National Institutes of Health Consensus Conference on Adjuvant Therapy of Breast Cancer recommended chemotherapy for all women with invasive cancer greater than 1 centimeter .
OBJECTIVE	Studies of long-term breast cancer survivors have found poorer quality of life ( QOL ) in women who received adjuvant chemotherapy .
OBJECTIVE	The aim of this article is to characterize physical and psychosocial recovery as a function of chemotherapy receipt in the year after medical treatment completion .
METHODS	Prospective longitudinal survey data ( RAND SF-36 and Breast Cancer Prevention Trial [ BCPT ] Symptom Scales ) collected from 558 women with breast cancer enrolled on the Moving Beyond Cancer ( MBC ) psychoeducational intervention trial were compared according to receipt of chemotherapy .
METHODS	MBC study enrollment occurred within 4 weeks after the end of primary treatment ( eg , surgery , chemotherapy , radiation ) .
METHODS	Self-report questionnaire data collected at enrollment and at 2 , 6 , and 12 months thereafter were examined , controlling for intervention and with propensity score adjustment for imbalance of covariates .
METHODS	Outcome analyses were carried out by fitting linear mixed models by using SAS PROC MIXED .
RESULTS	Longitudinal SF-36 scale scores did not differ by chemotherapy treatment exposure , and both groups improved significantly ( P < .01 ) in the year after primary treatment ended .
RESULTS	However , adjuvant chemotherapy treatment was associated with significantly more severe physical symptoms , including musculoskeletal pain ( P = .01 ) , vaginal problems ( P < .01 ) , weight problems ( P = .01 ) , and nausea ( P = .03 ) .
CONCLUSIONS	Physical and psychosocial functioning improved significantly after breast cancer treatment , independent of receipt of adjuvant chemotherapy .
CONCLUSIONS	Women who received chemotherapy experienced more severe and persistent physical symptoms that should be more effectively managed as part of survivorship care .

###17803835
BACKGROUND	Functional brain-imaging studies in post-traumatic stress disorder ( PTSD ) have suggested functional alterations in temporal and prefrontal cortical regions .
BACKGROUND	Effects of psychotherapy on these brain regions have not yet been examined .
METHODS	Twenty civilian PTSD out-patients and 15 traumatized control subjects were assessed at baseline using psychometric ratings .
METHODS	Cerebral blood flow was measured using trauma script-driven imagery during 99mtechnetium hexamethyl-propylene-amine-oxime single-photon emission computed tomography scanning .
METHODS	All 20 out-patients were randomly assigned to treatment or wait-list conditions .
METHODS	Treatment was brief eclectic psychotherapy ( BEP ) in 16 weekly individual sessions .
RESULTS	At baseline , greater activation was found in the right insula and right superior/middle frontal gyrus in the PTSD group than in the control group .
RESULTS	PTSD patients treated with BEP significantly improved on all PTSD symptom clusters compared to those on the waiting list .
RESULTS	After effective psychotherapy , lower activation was measured in the right middle frontal gyrus , compared to the PTSD patients on the waiting list .
RESULTS	Treatment effects on PTSD symptoms correlated positively with activation in the left superior temporal gyrus , and superior/middle frontal gyrus .
CONCLUSIONS	BEP induced clinical recovery in PTSD patients , and appeared to modulate the functioning of specific PTSD-related sites in the prefrontal cortical regions .

###12828139
BACKGROUND	In 2 previous multicenter studies evaluating the efficacy of a novel anesthetic gel ( lidocaine 25 mg/g plus prilocaine 25 mg/g ) , there was a rather small , although statistically significant , overall difference between the active and placebo gels .
BACKGROUND	There were , however , large center variations .
BACKGROUND	At centers where the placebo-treated patients reported high pain scores , the difference between treatments was large , suggesting that the anesthetic gel is most effective in patients who experience the procedure as painful .
BACKGROUND	The present multicenter , double-blind , randomized study evaluated the anesthetic effect of this gel in pain-sensitive patients by using a visual analog scale ( VAS ) and a verbal rating scale ( VRS ) .
METHODS	One hundred thirteen ( 113 ) patients with moderate to severe periodontitis were screened for pain sensitivity upon probing .
METHODS	Eighty-five reported VAS > or = 30 mm on probing and were included in the treatment phase ( 43 anesthetic and 42 placebo gel ) .
METHODS	The periodontal pockets of one quadrant in each patient were treated with gel for 30 to 45 seconds , followed by scaling and/or root planing .
RESULTS	The results were similar between centers .
RESULTS	The median overall VAS pain score was 11 mm in the anesthetic group and 27 mm in the placebo group .
RESULTS	The Hodges-Lehmann point estimate of the treatment difference was 10 mm ( P = 0.004 ) .
RESULTS	No pain or only mild pain was reported by 70 % in the anesthetic group and by 48 % in the placebo group ( P = 0.003 ) .
RESULTS	Two patients in the anesthetic group and 7 patients in the placebo group required rescue anesthesia .
CONCLUSIONS	This study confirms the favorable anesthetic efficacy of active gel over placebo in selected pain-sensitive patients .
CONCLUSIONS	It suggests that the gel may be a valuable alternative to conventional injection anesthesia .

###25375047
BACKGROUND	Seroma formation is the most frequent postoperative complication after axillary dissection for breast surgery with an incidence of 10 - 50 % .
BACKGROUND	This prospective clinical randomized study was carried out to evaluate the Ligasure vessel sealing system and its effect on seromaformation and other complications for axillary dissection .
METHODS	Between January 2006 and November 2007 , the patients with histopathological diagnosis of breast cancer were analysed prospectively .
METHODS	The patients with positive sentinel lymph node biopsy or clinical axillary involvement were included in the study , and the patients who underwent neoadjuvant therapy or using anticoagulants have been excluded from the study .
METHODS	Patients were divided into two study groups.Axillary dissection was performed in the first group by LigaSure and in the second group by linking and electrocautery .
RESULTS	There were a total of thirty three patients with a mean age of 51.4 + - 13.7 .
RESULTS	In group one , mean age of patients was 54.1 + - 13.2 and 48.68 + - 14.1 in group two .
RESULTS	There was no significant statistical difference between the groups regarding age , body mass index , excised tissue weight , tumour size and number of excised lymph nodes .
RESULTS	The use of Ligasure reduced drainage amount and duration of drain till removal , but increased operative time .
CONCLUSIONS	There were no significant differences between study groups regarding the complications .
CONCLUSIONS	LigaSure electrothermal bipolar vessel sealing system can be safely used in axillary dissection as an alternative to traditional methods .

###14514574
OBJECTIVE	To examine the effect of vitamin C on forearm vasodilatory response to reactive hyperemia and on plasma level of plasminogen activator inhibitor 1 ( PAI-1 ) , von Willebrand factor ( vWF ) , tissue plasminogen activator ( tPA ) , antithrombin III ( ATIII ) , proteins C and S , and factors V ( fV ) and VII ( fVII ) in patients with both type 2 diabetes and CAD .
METHODS	A total of 39 patients with type 2 diabetes and CAD were divided into two groups and received vitamin C ( 2 g/day ) or no antioxidant for 4 weeks .
METHODS	Forearm blood flow was determined using venous occlusion gauge-strain plethysmography at baseline and after treatment .
METHODS	Forearm vasodilatory response to reactive hyperemia ( RH % ) or nitrate ( NTG % ) was defined as the percent change of flow from baseline to the maximum flow during reactive hyperemia or after administration of nitrate , respectively .
METHODS	Biochemical markers were determined by enzyme-linked immunosorbent assay ( ELISA ) or other standard methods .
RESULTS	RH % was significantly increased after treatment with vitamin C ( from 62.4 + / - 7.2 to 83.1 + / - 9.3 % , P = 0.024 ) but remained unaffected in the control group .
RESULTS	Vitamin C decreased plasma levels of fV ( from 143 + / - 5.4 to 123 + / - 6.03 % , P = 0.038 ) , vWF ( from 133.5 + / - 14.5 to 109.5 + / - 11.4 % , P = 0.016 ) , and tPA ( from 12.3 + / - 0.99 to 8.40 + / - 0.60 ng/ml , P = 0.001 ) , whereas these levels remained unaffected in the control group .
RESULTS	The changes in RH % , vWF , and tPA were significantly greater ( P = 0.028 , 0.036 , and 0.007 , respectively ) in the vitamin C-treated group than in the control group .
RESULTS	Levels of ATIII , proteins S and C , fVII , and PAI-1 remained unchanged in all groups .
CONCLUSIONS	Short-term treatment with high doses of vitamin C improved RH % and decreased plasma levels of tPA and vWF in patients with type 2 diabetes and CAD .

###17893454
BACKGROUND	Tracheal intubation with neuromuscular blocking agents is associated with a low incidence of minor vocal cord sequelae ( 8 % ) .
BACKGROUND	The aim of this noninferiority trial was to demonstrate that the frequency of vocal cord sequelae after fiberoptic intubation with a flexible silicone tube without neuromuscular blocking agents was less than 25 % ( maximum tolerable inferiority ) .
METHODS	Two-hundred seventy patients were prospectively randomized to two groups .
METHODS	All intubations were performed by anesthesiologists with extensive experience in fiberoptic and conventional techniques .
METHODS	Fiberoptic nasotracheal intubation consisted of a bolus dose of 2 microg/kg fentanyl ; 0.25 ml cocaine instillation , 10 % , into nasal canals ; cricothyroid injection of 2 ml lidocaine , 1 % ; bronchoscopy ; administration of 0.3 mg/kg etomidate ; and advancing a flexible silicone tube after loss of consciousness .
METHODS	Orotracheal intubation was performed with a polyvinyl chloride tube after induction with 2 microg/kg fentanyl , 2 mg/kg propofol , and 0.6 mg/kg rocuronium .
METHODS	Patients were examined by laryngoscopy before surgery , 24 h after surgery , and daily until complete restitution .
METHODS	Postoperative hoarseness was assessed by a standardized interview .
RESULTS	The incidence of vocal cord sequelae was 11 out of 130 ( 8.5 % ) in the fiberoptic group versus 12 out of 129 ( 9.3 % ) in the control group ( chi-square = 0.057 , df = 1 , P = 0.81 ; upper limit of the one-sided 95 % confidence interval for the difference : +5.1 % ) .
RESULTS	There were no persistent injuries .
RESULTS	The incidence of postoperative hoarseness was 4 % in both groups .
CONCLUSIONS	Because fiberoptic intubation without neuromuscular blocking agents is safe regarding vocal cord sequelae , routine use is justified for anesthesiologists experienced in this technique .

###11783155
OBJECTIVE	To investigate the effect of Shenmai injection ( SMI ) on neuroendocrine function in the patients with heart failure ( HF ) .
METHODS	Sixty patients with HF were randomly divided into the treated group administered with SMI combined with western medicine , and the control group administered with western medicine alone .
METHODS	The change of cardiac function was observed , and plasma neuropeptide Y ( NPY ) , endothelin ( ET ) and atrial natriuretic polypeptide ( ANP ) were determined by immunoradiometric assay .
RESULTS	The total effective rate and markedly effective rate were higher in the treated group than that of the control group , the level of NPY , ET and ANP of both groups were higher than healthy subjects .
RESULTS	The plasma NPY , ET and ANP of both groups were significantly reduced after treatment , the effect of treated group was better than that of control group .
CONCLUSIONS	SMI could improve the HF patient 's cardiac function , reduce the level of plasma NPY , ET and ANP , their neuroendocrine activity was affected at the same time .

###23013200
BACKGROUND	This study evaluated whether education and use of the advanced meter features of the CONTOUR ( ) ( Bayer HealthCare LLC , Diabetes Care , Tarrytown , NY ) blood glucose monitoring system ( BGMS ) affect the frequency and pattern of blood glucose testing in insulin-using subjects with diabetes who routinely perform self-monitoring of blood glucose ( SMBG ) .
METHODS	Insulin-using subjects with type 1 or type 2 diabetes were enrolled in this 6-month , multicenter , prospective study and randomized to one of two groups .
METHODS	The basic meter features group ( BMF group ) received basic instruction in the use of the BGMS , whereas the advanced meter features group ( AMF group ) also received training in the use of advanced features , including the meal marker and audible reminder , and were instructed to use these features .
METHODS	Both groups received education on the importance of postprandial testing .
RESULTS	The AMF group ( n = 105 ) had significantly greater average weekly postprandial blood glucose testing than the BMF group ( n = 106 ) at each follow-up visit ( P < 0.001 ) and significantly increased the frequency of paired blood glucose testing ( P < 0.001 ) as well .
RESULTS	In both groups , glycated hemoglobin decreased significantly as postprandial testing frequency increased ( P < 0.05 ) .
RESULTS	Subject reports indicated that use of advanced features made postmeal SMBG considerably easier to remember , helped them better understand how to make decisions on their own , and increased their confidence in meal choices .
CONCLUSIONS	Study findings showed that advanced features of the CONTOUR BGMS increased structured testing as measured by postprandial and paired SMBG and were perceived as useful by patients .

###24439655
BACKGROUND	Neuropeptide S Receptor ( NPSR1 ) gene has been associated with multiple allergic phenotypes in several patient populations .
OBJECTIVE	We analysed the effect of the NPSR1 genotypes in the development of asthma , rhinitis , eczema , or food allergy in children randomly receiving either probiotic or placebo treatment .
METHODS	796 children born to families at high risk for allergic diseases were examined by a paediatrician at the age of three months , six months , two years , and five years .
METHODS	Asthma , rhinitis , eczema , and food allergy were diagnosed according to international guidelines .
METHODS	Treatment with probiotics ( double-blinded and placebo controlled ) was begun with mothers at 35 weeks of gestation age and continued after the birth of infants up to the age of six months .
METHODS	Association and additive inheritance models were used in genetic analyses .
RESULTS	Distribution of the hopo546333 was suggestive in the group of patients with atopic eczema at two years .
RESULTS	The hopo546333_G was found more often in those with eczema in the placebo group ( p = 0.048 , after Bonferroni correction ) and the hopo546333_A was found more often in those with eczema and probiotics compared to those with eczema and placebo treatment .
RESULTS	None of the NPSR1 tagging SNPs was associated with asthma , IgE-mediated asthma , or sensitisation .
RESULTS	Allergic disease in both parents doubled the risk for IgE-mediated allergic disease ( OR 2.1 ) .
CONCLUSIONS	The NPSR1 gene SNP hopo546333 showed a suggestive association for high IgE-associated atopic eczema at two years .

###20102875
BACKGROUND	Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention ( PCI ) .
BACKGROUND	No uniform definitions exist for major and minor bleeding .
BACKGROUND	Hematomas > or = 5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others .
BACKGROUND	Limited information is available on the incidence and clinical relevance of hematomas > or = 5 cm in PCI patients .
METHODS	Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas > or = 5 cm on ischemic outcomes ( mortality , nonfatal myocardial infarction , or urgent target vessel revascularization ) up to day 30 and all-cause 1-year mortality .
METHODS	Hematoma data were available for 3,342 of 3,528 patients in STEEPLE .
METHODS	Patients with ( n = 103 ) and without ( n = 3,239 ) hematomas > or = 5 cm were evenly distributed across treatment groups .
RESULTS	No differences were observed in 30-day ischemic outcomes between patients with and without hematomas ( 5.8 % vs 5.9 % , respectively ; P = .96 ) .
RESULTS	No transfusions were observed in patients with hematomas as compared with patients without hematomas ( 0 % and 0.4 % , respectively ; P = .52 ) .
RESULTS	A greater reduction in hemoglobin was observed ( pre - vs post-PCI ) in patients with hematomas as compared with patients without hematomas ( -0.84 vs -0.35 g/L , P < or = .001 ) .
RESULTS	No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas ( 0.0 % vs 1.7 % , P = .98 ) .
CONCLUSIONS	After PCI , hematomas > or = 5 cm had no effect on 30-day ischemic events or 1-year mortality .
CONCLUSIONS	Although there is no agreed classification for large hematomas , the lack of a relationship between hematomas > or = 5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE .

###19688338
OBJECTIVE	The aim of the study was to compare the efficacy and safety of liraglutide in type 2 diabetes mellitus vs placebo and insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) , all in combination with metformin and glimepiride .
METHODS	This randomised ( using a telephone or web-based randomisation system ) , parallel-group , controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy ( HbA ( 1c ) 7.5-10 % ) and combination therapy ( 7.0-10 % ) was conducted in 107 centres in 17 countries .
METHODS	The primary endpoint was HbA ( 1c ) .
METHODS	Patients were randomised ( 2:1:2 ) to liraglutide 1.8 mg once daily ( n = 232 ) , liraglutide placebo ( n = 115 ) and open-label insulin glargine ( n = 234 ) , all in combination with metformin ( 1 g twice daily ) and glimepiride ( 4 mg once daily ) .
METHODS	Investigators , participants and study monitors were blinded to the treatment status of the liraglutide and placebo groups at all times .
RESULTS	The number of patients analysed as intention to treat were : liraglutide n = 230 , placebo n = 114 , insulin glargine n = 232 .
RESULTS	Liraglutide reduced HbA ( 1c ) significantly vs glargine ( 1.33 % vs 1.09 % ; -0.24 % difference , 95 % CI 0.08 , 0.39 ; p = 0.0015 ) and placebo ( -1.09 % difference , 95 % CI 0.90 , 1.28 ; p < 0.0001 ) .
RESULTS	There was greater weight loss with liraglutide vs placebo ( treatment difference -1.39 kg , 95 % CI 2.10 , 0.69 ; p = 0.0001 ) , and vs glargine ( treatment difference -3.43 kg , 95 % CI 4.00 , 2.86 ; p < 0.0001 ) .
RESULTS	Liraglutide reduced systolic BP ( -4.0 mmHg ) vs glargine ( +0.5 mmHg ; -4.5 mmHg difference , 95 % CI 6.8 , -2.2 ; p = 0.0001 ) but not vs placebo ( p = 0.0791 ) .
RESULTS	Rates of hypoglycaemic episodes ( major , minor and symptoms only , respectively ) were 0.06 , 1.2 and 1.0 events/patient/year , respectively , in the liraglutide group ( vs 0 , 1.3 , 1.8 and 0 , 1.0 , 0.5 with glargine and placebo , respectively ) .
RESULTS	A slightly higher number of adverse events ( including nausea at 14 % ) were reported with liraglutide , but only 9.8 % of participants in the group receiving liraglutide developed anti-liraglutide antibodies .
CONCLUSIONS	Liraglutide added to metformin and sulfonylurea produced significant improvement in glycaemic control and bodyweight compared with placebo and insulin glargine .
CONCLUSIONS	The difference vs insulin glargine in HbA ( 1c ) was within the predefined non-inferiority margin .
BACKGROUND	ClinicalTrials.gov NCT00331851 .
BACKGROUND	The study was funded by Novo Nordisk A/S .

###8537627
OBJECTIVE	To determine if an attachable silver-impregnated cuff is effective in reducing subclavian hemodialysis catheter-related infections .
METHODS	Prospective , randomized , nonblinded study .
METHODS	Community teaching hospital .
METHODS	One hundred one acute and chronic renal failure patients requiring subclavian venipuncture and catheterization .
METHODS	After randomization , 47 patients underwent subclavian catheterization with a silver-impregnated cuff ( Ag-CC ) , and 54 patients had routine catheter ( RC ) placements .
METHODS	Multiple presumed predictor variables for catheter-related infections , exit site infection rate , bacteremia rates , and semiquantitative cultures of all catheters .

###8940320
OBJECTIVE	To determine the long-term effectiveness of comprehensive support and counseling for spouse-caregivers and families in postponing or preventing nursing home placement of patients with Alzheimer disease ( AD ) .
METHODS	Randomized controlled intervention study .
METHODS	Outpatient research clinic in the New York City metropolitan area .
METHODS	Referred , volunteer sample of 206 spouse-caregivers of AD patients who enrolled in the study during a 3 1/2 - year period .
METHODS	All patients were living at home at baseline and had at least 1 relative living in the area .
METHODS	Caregivers in the treatment group were provided with 6 sessions of individual and family counseling within 4 months of enrollment in the study and were required to join support groups .
METHODS	In addition , counselors were available for further counseling at any time .
METHODS	Time from enrollment of caregivers in the study to placement of the AD patients in a nursing home .
RESULTS	Using Kaplan-Meier survival analysis , we estimated that the median time ( weighted average of estimates for male and female caregivers ) from baseline to nursing home placement of AD patients was 329 days longer in the treatment group than in the control group ( z = 2.29 ; P = .02 ) .
RESULTS	The relative risk ( RR ) from a Cox proportional hazard model of nursing home placement ( intent-to-treat estimate ) after adjusting for caregiver sex , patient age , and patient income was 0.65 ( 95 % confidence interval [ CI ] , 0.45 to 0.94 ; P = .02 ) , indicating that caregivers were approximately two thirds as likely to place their spouses in nursing homes at any point in time if they were in the treatment group than if they were in the control group .
RESULTS	Treatment had the greatest effect on risk of placement for patients who were mildly demented ( RR , 0.18 ; 95 % CI , 0.04 to 0.77 ) or moderately demented ( RR , 0.38 ; 95 % CI , 0.17 to 0.82 ) .
CONCLUSIONS	A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home , particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate .

###22156352
OBJECTIVE	to investigate the effect of consumption of dark chocolate 30 g/day for fifteen days on Nitric oxide ( NO ) serum levels and blood pressure in male and female employees with prehypertension .
METHODS	the study was a parallel randomized clinical trial .
METHODS	A total of thirty-two subjects was divided into two groups using block randomization .
METHODS	Sixteen subjects received 30 g/day dark chocolate and dietary counseling ( treatment group ) and the other 16 subjects received white chocolate 25 g/day and dietary counseling ( control group ) for fifteen days .
METHODS	Data collected in this study consisted of age , physical activity , body massa index , intake of energy , intake of sodium , and intake of polyphenol , NO serum levels and blood pressure .
METHODS	The measurement of NO serum levels was done in pre - and after - treatment , while blood pressure was assessed in pre - , during - and after - treatment .
METHODS	Statistical analysis was performed using independent t-test for normal distribution data and Mann-Whitney test for not normal distribution data , with the level of significancy of 5 % .
RESULTS	after 15 days treatment , NO serum level between treatment and control groups were significantly different 7.70 3.84 vs 1.92 ( -0.79 17.78 ) ( p = 0.001 ) .
RESULTS	Both groups had decreased systolic and diastolic blood pressure .
RESULTS	Systolic blood pressure was different significantly between groups after treatment 120.64 8.47 vs 131.19 7.45 ( p = 0.001 ) , while diastolic blood pressure was not significant 74.14 6.30 vs 77.44 10.29 ( p = 0.308 ) .
CONCLUSIONS	in prehypertension subjects , dark chocolate 30 g/day increased NOx serum levels and decreased systolic blood pressure after 15 days of treatment .

###9509822
OBJECTIVE	The purpose of the study was to determine the effect of six months of heavy resistance training ( weightlifting ) on the bone density of premenopausal women .
METHODS	A 6-month prospective design with random assignment to groups .
METHODS	Measurements of bone mineral density ( BMD ) were obtained from the Radiology Clinic at North Carolina Memorial Hospital .
METHODS	Exercise sessions were completed in the Physical Education Department facilities at the University of North Carolina , Chapel Hill , NC .
METHODS	Thirty-five premenopausal women , 40-50 years of age , were randomly assigned to either a resistance training ( RT ) and sedentary control ( CON ) group .
METHODS	The study finished with 12 women exercising and 14 in the control group .
METHODS	The resistance training consisted of three days per week of high-intensity weightlifting specifically designed to place strain on the spine and hips .
METHODS	Bone density of the lumbar vertebrae , femoral neck , and distal radius , were determined prior to and at the end of the exercise program using dual energy X-ray absorptiometry ( DEXA ) .
RESULTS	Resistance-training produced strength gains : overhead press = 125 % , leg press = 86 % , and calf raises = 91 % ( p < 0.001 ) .
RESULTS	RT tended to increased lumbar BMD 1.03 % , while the CON decreased 0.36 % ( p = 0.072 ) .
RESULTS	Both groups lost radial BMD ( CON = -0.45 % ; RT = -1.04 % ) .
RESULTS	Both groups gained femoral neck BMD ( CON = 1.26 % ; RT = 1.22 % ) .
CONCLUSIONS	These results suggest that even a short-term weight training program can either maintain or improve the BMD of the femoral neck and lumbar vertebrae in premenopausal women .

###9726382
OBJECTIVE	To compare the efficacy and tolerability of olsalazine sodium with enteric-coated mesalazine in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis .
METHODS	Patients with mild to moderate active ulcerative colitis were randomized to receive either olsalazine sodium , 3 g/day ( n = 88 ) , or mesalazine , 3 g/day ( n = 80 ) , for up to 12 weeks .
RESULTS	Of the patients treated with olsalazine sodium , 52.2 % achieved endoscopic remission , compared with 48.8 % of patients treated with mesalazine .
RESULTS	This difference was not significant ( P = 0.67 ) .
RESULTS	There was a nonsignificant trend for patients with left-sided colitis or a more severe endoscopic grade to achieve remission if they were treated with olsalazine sodium than if they were treated with mesalazine .
RESULTS	Both treatments were comparable with respect to clinical activity index and an investigator 's global assessment .
RESULTS	Seventy patients reported one or more adverse events ; adverse events were seen in 45 % of olsalazine sodium-treated patients and in 36 % of mesalazine-treated patients .
RESULTS	Eleven patients treated with olsalazine sodium and nine patients treated with mesalazine withdrew from the study because of adverse events .
RESULTS	One patient treated with olsalazine sodium compared with two treated with mesalazine stopped treatment because of diarrhoea .
RESULTS	Serious adverse events occurred in three patients treated with olsalazine sodium and in four treated with mesalazine .
CONCLUSIONS	Therapeutic effectiveness and tolerance to the treatment did not differ between olsalazine sodium , 3 g/day , and mesalazine , 3 g/day , in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis within 12 weeks of treatment .

###24083403
OBJECTIVE	To describe quality of care for feeding problems in advanced dementia and probability and predictors of weight loss and mortality .
METHODS	Prospective cohort .
METHODS	Twenty-four nursing homes ( NHs ) .
METHODS	Nursing home residents with advanced dementia and feeding problems and family surrogates ( N = 256 ) .
METHODS	Family reported on quality of feeding care at enrollment and 3 months .
METHODS	Chart reviews at enrollment and 3 , 6 , and 9 months provided data on feeding problems , treatments , weight loss of more than 5 % in 30 days or more than 10 % in 6 months , and mortality .
METHODS	Organizational variables were obtained from administrator surveys and publically reported data .
RESULTS	Residents with advanced dementia and feeding problems had an average age of 85 ; 80 % had chewing and swallowing problems , 11 % weight loss , and 48 % poor intake .
RESULTS	Family reported feeding assistance of moderate quality ; 23 % felt the resident received less assistance than needed .
RESULTS	Mortality risk was significant ; 8 % died within 3 months , 17 % within 6 months , and 27 % within 9 months .
RESULTS	Residents with advanced dementia who had stable weight over 3 months had a 5.4 % rate of significant weight loss and a 2.1 % risk of death over the next 3 months .
RESULTS	Residents with advanced dementia and weight loss over 3 months had a 38.9 % chance of stabilizing weight over the next 3 months but also had a 19.2 % chance of dying .
RESULTS	Weight loss was the only independent predictor of death .
CONCLUSIONS	Weight loss is a predictor of death in advanced dementia .
CONCLUSIONS	Treatments can often stabilize weight , but weight loss should be used to trigger discussion of goals of care and treatment options .

###19783324
OBJECTIVE	We determine whether the use of capnography is associated with a decreased incidence of hypoxic events than standard monitoring alone during emergency department ( ED ) sedation with propofol .
METHODS	Adults underwent ED propofol sedation with standard monitoring ( pulse oximetry , cardiac and blood pressure ) and capnography and were randomized into a group in which treating physicians had access to the capnography and a blinded group in which they did not .
METHODS	All patients received supplemental oxygen ( 3 L/minute ) and opioids greater than 30 minutes before .
METHODS	Propofol was dosed at 1.0 mg/kg , followed by 0.5 mg/kg as needed .
METHODS	Capnographic and SpO2 data were recorded electronically every 5 seconds .
METHODS	Hypoxia was defined as SpO2 less than 93 % ; respiratory depression , as end tidal CO2 ( ETCO2 ) greater than 50 mm Hg , ETCO2 change from baseline of 10 % , or loss of the waveform .
RESULTS	One hundred thirty-two subjects were evaluated and included in the final analysis .
RESULTS	We observed hypoxia in 17 of 68 ( 25 % ) subjects with capnography and 27 of 64 ( 42 % ) with blinded capnography ( P = .035 ; difference 17 % ; 95 % confidence interval 1.3 % to 33 % ) .
RESULTS	Capnography identified all cases of hypoxia before onset ( sensitivity 100 % ; specificity 64 % ) , with the median time from capnographic evidence of respiratory depression to hypoxia 60 seconds ( range 5 to 240 seconds ) .
CONCLUSIONS	In adults receiving ED propofol sedation , the addition of capnography to standard monitoring reduced hypoxia and provided advance warning for all hypoxic events .

###21353334
BACKGROUND	Lichen sclerosus ( LS ) is a lymphocyte-mediated chronic cutaneous disorder with a predilection for the vulva .
BACKGROUND	The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol .
OBJECTIVE	We sought to compare the safety and efficacy of clobetasol and pimecrolimus in the treatment of vulvar LS .
METHODS	This double-blind , randomized trial enrolled 38 women with biopsy-proven vulvar LS .
METHODS	This study consisted of a 2-week screening period and a 12-week treatment period .
METHODS	The primary efficacy variable was the change in inflammation , as determined by a dermatopathologist , on the biopsy specimens obtained at screening and at the week 12 visit .
METHODS	Secondary efficacy variables included the change from baseline in pruritus and burning/pain as assessed by patients using a visual analog scale and a clinical evaluation by the investigator .
RESULTS	Clobetasol was found to be superior in improving inflammation when compared with pimecrolimus ( P = .015 ) .
RESULTS	Both groups showed improvement in pruritus and burning/pain but this difference was not statistically significant ( P = .32 and .93 , respectively ) .
RESULTS	Both clobetasol and pimecrolimus were found to be effective in decreasing both the total score on the Investigator Global Assessment ( P = .001 ) and all 3 subscales .
RESULTS	Serum levels of pimecrolimus and clobetasol did not approach levels of concern during the study period .
RESULTS	No adverse events were reported .
CONCLUSIONS	This study was limited by the relatively short study duration .
CONCLUSIONS	Both clobetasol and pimecrolimus appear efficacious and well tolerated for the treatment of vulvar LS ; however , clobetasol is more effective than pimecrolimus and should remain first-line therapy for LS .

###24736677
OBJECTIVE	To examine the effectiveness , acceptability and sustainability of interventions to reduce vitamin B12 ( B12 ) deficiency in South Asian women before conception .
METHODS	A 6-month randomised controlled trial conducted in Auckland , New Zealand .
METHODS	Participants ( 62 South Asian women , 18-50 years old ) were stratified by dietary practices , then randomised to three treatment groups : B12 Supplement ( oral cyanocobalamin 6g/day ) ( n = 21 ) , Placebo ( n = 21 ) , or B12 Dietary Advice ( n = 20 ) .
METHODS	Primary outcome measures were changes in B12 biomarkers ( serum B12 and holotranscobalamin ( holoTC ) ) at 6 months .
METHODS	Dietary B12 intake was estimated from a B12 food-specific frequency questionnaire ( B12FFQ ) .
METHODS	Intention-to-treat analysis was applied using ` last observation carried forward ' method .
METHODS	Changes in B12 biomarkers by treatment were compared using analysis of variance .
METHODS	Pearson 's correlations tested relationships between dietary B12 intake and B12 biomarkers .
RESULTS	At baseline , 48 % of women tested as insufficient or deficient in serum B12 ( < 222pmol/l ) and 51 % as insufficient or deficient in holoTC ( < 45pmol/l ) .
RESULTS	B12 status was moderately correlated with dietary B12 intake ( r = 0.5 , 95 % confidence interval ( CI ) ( 0.3-0 .7 ) ) and 44 % of women reported insufficient dietary intake ( < 2.4 g/day ) .
RESULTS	B12 Supplement was the only treatment group to record a significant increase in B12 biomarkers over 6 months : serum B12 by 30 % ( 95 % CI ( 11-48 % ) ) and holoTC by 42 % ( 12-72 % ) .
CONCLUSIONS	The prevalence of B12 insufficiency among Auckland South Asian women is high and moderately correlated with inadequate intake of foods that contain B12 .
CONCLUSIONS	Cyanocobalamin supplementation ( 6g/day ) was associated with improved B12 biomarkers , with a potential to improve preconception B12 status in South Asian women .

###23249655
OBJECTIVE	Chronic neck pain is a significant public health problem with only very few evidence-based treatment options .
OBJECTIVE	There is growing evidence for the effectiveness of yoga for relieving musculoskeletal disorders .
OBJECTIVE	The aim of this study was to evaluate the effect of Iyengar yoga compared with exercise on chronic nonspecific neck pain .
METHODS	Patients were randomly assigned to either yoga or exercise .
METHODS	The yoga group attended a 9-week yoga course and the exercise group received a self-care manual on home-based exercises for neck pain relief .
METHODS	The main outcome measure was the present neck pain intensity ( 100 mm visual analog scale ) .
METHODS	Secondary outcome measures included functional disability ( Neck Disability Index ) , pain at motion ( visual analog scale ) , health-related quality of life ( Short Form-36 questionnaire ) , cervical range of motion , proprioceptive acuity , and pressure pain threshold .
RESULTS	Fifty-one patients ( mean age 47.8 y ; 82.4 % female ) were randomized to yoga ( n = 25 ) and exercise ( n = 26 ) intervention .
RESULTS	After the study period , patients in the yoga group reported significantly less neck pain intensity compared with the exercise group [ mean difference : -13.9 mm ( 95 % CI , -26.4 to -1.4 ) , P = 0.03 ] .
RESULTS	The yoga group reported less disability and better mental quality of life .
RESULTS	Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group .
CONCLUSIONS	Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program .
CONCLUSIONS	Yoga reduced neck pain intensity and disability and improved health-related quality of life .
CONCLUSIONS	Moreover , yoga seems to influence the functional status of neck muscles , as indicated by improvement of physiological measures of neck pain .

###23957255
OBJECTIVE	Depression and anxiety related to stroke are caused by vascular lesions and psychological reactions .
OBJECTIVE	Treatment of vascular and modifiable behavioral risk factors reduces the risk of stroke and may also reduce the risk of emotional changes after stroke .
OBJECTIVE	We aimed to investigate whether a multifactorial risk factor intervention program in patients with first-ever stroke or transient ischemic attack ( TIA ) can influence post-stroke anxiety and depressive symptoms in patients one year post-stroke .
METHODS	The study population consisted of first-ever stroke and TIA patients allocated in a randomized , evaluator-blinded , controlled trial to care as usual or a structured and multidisciplinary follow-up including intensive treatment of vascular risk .
METHODS	The primary endpoint ( cognition ) has previously been reported .
METHODS	The secondary endpoint , reported here , was changes in the Hospital Anxiety and Depression Scale ( HADS ) from baseline to 12-month follow-up .
RESULTS	One hundred and ninety-five patients were randomized .
RESULTS	The estimated difference between treatment groups , in changes in HADS , from baseline to 12 months was -1.32 ( 95 % confidence interval : -2.61 , -0.04 ; P = 0.044 ) in favor of the intervention group .
RESULTS	One year post-stroke , 4/85 ( 4.7 % ) patients in the intervention group and 12/89 ( 13.5 % ) in the control group suffered from depression ( P = 0.045 ) , while 7/85 ( 8.2 % ) patients in the intervention group and 13/89 ( 14.6 % ) patients in the control group suffered from anxiety ( P = 0.19 ) .
CONCLUSIONS	A structured , multidisciplinary , multifactorial risk factor program including vascular risk factor management may be associated with reduced HADS scores and a lower prevalence of depressive symptoms one year after stroke .

###19561372
BACKGROUND	Interval cycle training could positively influence dynamic balance in middle-aged women .
OBJECTIVE	To compare training effects of a strength ergometer and a standard ergometer on 3 dynamic balance tests .
METHODS	Repeated measures .
METHODS	Laboratory .
METHODS	Seventeen women were randomly assigned to standard ( n = 10 ) or strength cycle ergometry ( n = 7 ) .
METHODS	A control group consisted of 7 women .
METHODS	Ergometry interval training ( 3 sessions/wk for 4 wk ) .
METHODS	Three balance tests-the Star Excursion Balance Test ( SEBT ) , timed up-and-go ( TUG ) , and four-square step test ( FSST ) - were performed at pretraining and 4 wk posttraining .
RESULTS	Four SEBT directions improved and faster scores for FSST and TUG tests for the standard-cycle group were found , whereas the strength-cycle group only improved their TUG scores .
RESULTS	No changes posttraining for the control group .
CONCLUSIONS	Stationary cycle training should be included in the dynamic balance-rehabilitation protocol for middle-aged women .

###24068158
OBJECTIVE	To date , no study has defined the consequences of radial artery harvest based on a large number of patients in a prospective randomized trial .
OBJECTIVE	To compare pain at the harvest site and functional changes associated with harvesting the radial artery vs saphenous vein for coronary artery bypass grafting .
METHODS	This study compares the consequences of radial artery harvest with saphenous vein harvest in patients undergoing elective coronary artery bypass grafting procedures in Veterans Affairs hospitals .
METHODS	Eleven hospitals screened 6148 patients , of whom 751 were included in this trial .
METHODS	We analyzed 2 variables : pain at the harvest site as measured on a scale of 0 to 100 ( least to most painful ) and hand performance testing .
METHODS	Patients included in this analysis had radial artery only ( n = 80 ) or saphenous vein only ( n = 337 ) harvest .
METHODS	Pain score , grip strength , and dexterity were measured before surgery and at 3 and 12 months after surgery .
METHODS	We adjusted for pain scores of the nonharvested extremity , age , whether the patient underwent endoscopic vein harvesting , and comorbid health conditions ( smoking history , type 2 diabetes mellitus , hypertension , and heart failure ) .
RESULTS	There was a significant difference in change of pain score at 3 months from the preoperative baseline between radial artery and saphenous vein groups after adjusting for covariates ( P < .001 ) but not at 12 months ( P = .07 ) .
RESULTS	No significant changes occurred in grip strength or dexterity from preoperative baseline to 3 and 12 months after surgery ( P > .05 ) .
CONCLUSIONS	The radial artery group reported significantly more pain than the saphenous vein group 3 months after surgery ; however , similar levels of pain were observed in both groups at 12 months after surgery .
CONCLUSIONS	Grip strength and manual dexterity were not changed by radial artery harvesting at 3 and 12 months .

###19915480
OBJECTIVE	To examine whether prophylactic use of haloperidol in addition to dexamethasone decreased the incidence of postoperative nausea and vomiting in high-risk patients undergoing ambulatory surgery .
METHODS	One hundred and sixty nonsmoking women aged between 18 and 50 years receiving a standardized anaesthesia , which included dexamethasone 8 mg at the beginning of cosmetic or ENT surgery , were enrolled .
METHODS	They were randomized to receive either 1.5 mg of haloperidol ( dexamethasone-haloperidol group ) or placebo ( dexamethasone-placebo group ) 30 min before the end of surgery .
METHODS	The incidence of postoperative nausea and vomiting was assessed by a blinded investigator at 30 min , 2 , 6 , and 24 h in the postoperative period .
METHODS	Analgesic requirements , eye opening time , and sedation were also assessed .
RESULTS	We found no differences in nausea or vomiting at 30 min and 2 h postoperatively ; we found no difference in the incidence of nausea between dexamethasone-haloperidol and dexamethasone-placebo groups at 6 h [ relative risk ( RR ) 0.82 , 95 % confidence interval ( CI ) 0.56-1 .25 ] and 24 h ( RR 0.79 , 95 % CI 0.56-1 .1 ) , but the cumulative incidence of vomiting in the dexamethasone-haloperidol group was significantly lower at 6 h ( RR 0.57 , 95 % CI 0.39-1 .05 ) and 24 h ( RR 0.54 , 95 % CI 0.31-0 .86 ) .
RESULTS	We found no differences in eye opening time and Ramsay score higher than 2 at 30 min and 2 h after surgery .
CONCLUSIONS	To combine 1.5 mg of haloperidol and 8 mg of dexamethasone reduces the cumulative incidence of postoperative vomiting at 6 and 24 h postoperatively in day patients at high risk of postoperative nausea and vomiting .

###15547086
OBJECTIVE	To study the effects of dehydroepiandrosterone ( prasterone , DHEA ) 200 mg/day on cytokine profiles in adult women with active systemic lupus erythematosus ( SLE ) .
METHODS	In a double blind , randomised , placebo controlled study conducted as part of a larger multicentre study , 30 adult women with active SLE received oral DHEA 200 mg/day or placebo for 24 weeks .
METHODS	Baseline prednisone ( < 10 mg/day ) and other concomitant SLE medications were to remain constant .
METHODS	The levels of cytokines including interleukin ( IL ) 1 , IL2 , interferon gamma , IL4 , and IL10 were determined by ELISA .
METHODS	The mean change from baseline to 24 weeks of therapy was analysed .
RESULTS	The two groups ( DHEA n = 15 ; placebo n = 15 ) were well balanced for baseline characteristics .
RESULTS	Only IL1beta and IL10 could be detected in the serum of lupus patients ; however , there was no significant mean ( SD ) difference in serum IL1beta before and after treatment ( 9.94 ( 8.92 ) v 9.20 ( 6.49 ) pg/ml ) .
RESULTS	IL10 demonstrated a greater and significant reduction from baseline ( 9.21 ( 9.66 ) to 1.89 ( 1.47 ) pg/ml in the DHEA treatment group ) .
CONCLUSIONS	In a 24 week study of adult Chinese women with mild to moderate SLE , treatment with DHEA 200 mg once daily resulted in significant reduction of serum levels of IL10 .
CONCLUSIONS	This finding may suggest why DHEA could significantly reduce lupus flares .

###11748512
OBJECTIVE	To assess the skills of anesthesiologists in the interpretation of chest radiographs .
METHODS	Randomized evaluation conducted among anesthesiologists and radiologists .
METHODS	Postgraduate Assembly of the New York State Society of Anesthesiologists in 1999 , and the Department of Radiology , New York University Medical Center .
METHODS	A total of 61 anesthesiologists ( 48 attending physicians ; 13 residents ) ; control group of 8 radiology residents ( all participants volunteered ) .
METHODS	After completing a demographic survey , participants were asked to review a series of 10 chest radiographs .
METHODS	A brief clinical scenario accompanied each radiograph .
METHODS	No time limit was set for these interpretations .
RESULTS	The demographic characteristics of the anesthesiology participants included university faculty ( 46 % ) , private group practitioners ( 41 % ) , independent practitioners ( 11 % ) , and 1 participant with an unspecified type of practice .
RESULTS	Additional training among the participants included internal medicine ( 31 % ) , surgery ( 19 % ) , and pediatrics ( 3 % ) ; 34 % did not specify any additional training .
RESULTS	Of the participants , 92 % were involved in cases requiring general anesthesia ; 96 % managed patients in the recovery room ; and 34 % managed patients in the intensive care unit .
RESULTS	Of participants , 80 % usually order chest radiographs , but only 42 % interpret the films themselves .
RESULTS	Misdiagnosed radiographs included pneumothorax by 11 % of participants , free air under the diaphragm by 41 % , bronchial perforation from a nasogastric tube by 28 % , right mainstem intubation by 20 % , superior vena cava perforation from a central venous catheter by 31 % , normal film by 75 % , negative pressure pulmonary edema by 16 % , left lower lobe collapse by 80 % , pulmonary infarction from a pulmonary artery catheter by 29 % , and tension pneumothorax by 41 % .
RESULTS	Overall scores of the attending physicians were not significantly different from that of residents ( p > 0.05 ) .
RESULTS	The control group of radiology residents scored significantly better ( mean , 83.7 ; p = 0.009 ) than the anesthesia residents ( mean , 62.8 ) and anesthesia attending physicians ( mean , 62.5 ) .
CONCLUSIONS	Anesthesiologists are deficient in skills for the interpretation of chest radiographs .
CONCLUSIONS	The skill level of university-based physicians is not greater than physicians in private practice , and skill level does not improve with level of training or experience .
CONCLUSIONS	Most anesthesiologists rely on radiologists for interpretative results .
CONCLUSIONS	Further training during the residency years may help improve diagnostic skills .

###17995495
OBJECTIVE	To study the prophylactic use of levonorgestrel intrauterine system ( LNG-IUS ) in the prevention of endometrial pathology in women having breast cancer treated with tamoxifen .
METHODS	Randomised controlled trial .
METHODS	A tertiary teaching hospital .
METHODS	One hundred and thirteen women ( 66 premenopausal/47 postmenopausal ) who required adjuvant tamoxifen for breast cancer after the completion of postoperative radiotherapy and chemotherapy .
METHODS	Women were randomised to treatment group ( prophylactic LNG-IUS insertion before the commencement of tamoxifen ) or control group .
METHODS	Uterine cavity was examined by outpatient hysteroscopy and endometrial biopsy before and at 12 months after commencement of tamoxifen .
METHODS	De novo endometrial pathology at 1 year of tamoxifen .
RESULTS	Women in the treatment group had a much lower incidence of endometrial polyp ( 1.8 versus 15.5 % , P = 0.017 ) ( relative risk : 0.12 ; 95 % CI : 0.02-0 .91 ) at 12 months .
RESULTS	There was no significant difference in the incidence of submucosal fibroid between the two groups ( 1.8 versus 3.4 % , P = 1.0 ) .
RESULTS	LNG-IUS was retained in 95 % women in the treatment group at 1 year .
CONCLUSIONS	LNG-IUS reduces the occurrence of de novo endometrial polyp in women treated with tamoxifen for breast cancer .

###16621906
BACKGROUND	Testicular production of steroids and gametes is under gonadotropin support , but there is little information as to the molecular mechanisms by which these are regulated in the human .
BACKGROUND	The testicular response to gonadotropin withdrawal is important for the development of effective contraceptive methods .
OBJECTIVE	Our objective was investigation of expression of genes in the normal human testis reflecting steroidogenesis , Sertoli cell function , and spermatogenesis after short-term gonadotropin withdrawal and the effects of activating testicular progesterone receptors .
METHODS	We conducted a randomized controlled trial at a research institute .
METHODS	Thirty healthy men participated .
METHODS	Subjects were randomized to no treatment or gonadotropin suppression by GnRH antagonist ( cetrorelix ) with testosterone ( CT group ) or with additional administration of the gestogen desogestrel ( CTD group ) for 4 wk before testicular biopsy .
METHODS	Gene expression was quantified by RT-PCR .
RESULTS	Both treatment groups showed similar suppression of gonadotropins and sperm production and markedly reduced expression of steroidogenic enzymes .
RESULTS	Addition of progestogen in the CTD group resulted in reduced expression of 5alpha-reductase type 1 compared with both controls and the CT group .
RESULTS	Inhibin-alpha and the spermatocyte marker acrosin-binding protein were significantly lower in the CTD but not CT groups , compared with controls , but did not differ between treated groups .
RESULTS	Men who showed greater falls in sperm production also showed reduced expression of these three genes but not of the spermatid marker protamine 1 .
CONCLUSIONS	These data provide evidence for direct progestogenic effects on the testis and highlight steroid 5alpha-reduction and disruption of spermiation as important components of the testicular response to gonadotropin withdrawal .

###22288082
BACKGROUND	Because standard home oxygen ( O2 ) systems deliver O2 at fixed rates , these systems are not designed to ensure optimal oxygen delivery based on physiologic need .
BACKGROUND	We tested the ability of the AccuO2 ( OptiSat Medical , Minneapolis , Minnesota ) , a portable , closed-loop , oximetry-driven , O2-conserving device to maintain SpO2 at 90 % , compared to continuous-flow oxygen and a standard O2-conserving device ( CR-50 , Puritan-Bennett , Pleasanton , California ) .
METHODS	We randomly assigned 28 patients who were on continuous home O2 for COPD to use each of 3 O2 delivery systems ( continuous-flow O2 , CR-50 , and AccuO2 ) for 8 hours a day , for 2 consecutive days , at home , at their current O2 prescription .
METHODS	We recorded SpO2 and calculated the conservation ratio ( duration of a given O2 supply with an O2-conserving device compared to continuous-flow O2 ) .
RESULTS	Twenty-two patients completed all 3 study arms ; 2 additional patients completed the AccuO2 arm and the continuous-flow O2 arm .
RESULTS	The mean SD SpO2 was 92 4 % with continuous-flow O2 , 92 4 % with the CR-50 , and 91 2 % with AccuO2 ( P = .006 for the AccuO2 vs continuous-flow O2 , P = .03 for the AccuO2 vs the CR-50 ) .
RESULTS	SpO2 variability was less with the AccuO2 ( P < .001 vs continuous-flow O2 and vs the CR-50 ) .
RESULTS	The conservation ratios were 9.9 7.3 for the AccuO2 and 2.6 1.0 for the CR-50 ( P < .001 ) .
CONCLUSIONS	Compared to continuous-flow O2 or the CR-50 , the AccuO2 maintained SpO2 closer to the target , and AccuO2 had a higher conservation ratio than CR-50 .

###19437082
BACKGROUND	Roux-en-Y gastric bypass ( RYGB ) restricts food intake .
BACKGROUND	Consequently , patients consume less calcium .
BACKGROUND	In addition , food no longer passes through the duodenum , the main site of calcium absorption .
BACKGROUND	Therefore , calcium absorption is significantly impaired .
BACKGROUND	The goal of this study is to compare two common calcium supplements in gastric bypass patients .
METHODS	Nineteen patients were enrolled in a randomized , double-blinded , crossover study comparing the absorption of calcium from calcium carbonate and calcium citrate salts .
METHODS	Serum and urine calcium levels were assessed for peak values ( C ( max ) ) and cumulative calcium increment ( area under the curve [ AUC ] ) .
METHODS	Serum PTH was assessed for minimum values ( PTH ( min ) ) and cumulative PTH decrement ( AUC ) .
METHODS	Statistical analysis was performed using a repeated analysis of variance model .
RESULTS	Eighteen subjects completed the study .
RESULTS	Calcium citrate resulted in a significantly higher serum C ( max ) ( 9.4 + 0.4 mg/dl vs. 9.2 + 0.3 mg/dl , p = 0.02 ) and serum AUC ( 55 + 2 mg/dl vs. 54 + 2 mg/dl , p = 0.02 ) .
RESULTS	Calcium citrate resulted in a significantly lower PTH ( min ) ( 24 + 11 pg/ml vs. 30 + 13 pg/ml , p = 0.01 ) and a higher AUC ( -32 + 51 pg/ml vs. -3 + 56 pg/ml , p = 0.04 ) .
RESULTS	There was a non-significant trend for higher urinary AUC in the calcium citrate group ( 76.13 + 36.39 mg/6 h vs. 66.04 + 40.82 , p = 0.17 ) .
CONCLUSIONS	Calcium citrate has superior bioavailability than calcium carbonate in RYGB patients .

###8614073
OBJECTIVE	To optimize cryopreservation methods for cultured epidermal allografts ( CEAs ) for transplantation onto wounds .
METHODS	Conditions were determined to optimize the cryopreservation of CEAs .
METHODS	Cryopreserved CEAs were then grafted onto 16 donor sites in a double blind randomized trial .
METHODS	CEAs were grown in culture .
METHODS	Viability of cryopreserved CEAs was determined by : 1 ) trypan blue dye exclusion ; 2 ) histology ; 3 ) flow cytometry ; and 4 ) acid lipase activity .
METHODS	Cryopreserved CEAs were grafted onto 16 donor sites .
METHODS	Wound healing assessments included 1 ) visual assessment of healing ; 2 ) histologic assessment of re-epithelialization and differentiation ; and 3 ) visual scar assessment .
RESULTS	CEAs were cryopreserved using a controlled rate freezer with an experimentally determined setting of -7 degrees C for the CEA freezing point .
RESULTS	Such freezing conditions resulted in retention of approximately 92 % of the original viability , no loss in basal keratinocytes as determined by flow cytometry , and no change in acid lipase activity .
RESULTS	CEAs cryopreserved according to this method were grafted onto 16 donor sites in a double blind randomized trial .
RESULTS	All donor sites underwent complete healing .
RESULTS	Histologic examination of biopsies taken from the center of the wound beds showed that CEA-treated wounds significantly accelerated the rate of re-epithelialization ( 7.8 + / - 0.6 days vs. 9.2 + / - 0.9 days for CEA - and control-treated wounds , respectively ; p = 0.039 ) and epithelial differentiation ( p = 0.023 ) compared with control sites .
RESULTS	Longterm results showed that CEA-treated wounds were comparable to control sites with regard to : 1 ) pigmentation ; 2 ) scar height ; 3 ) scar pliability ; 4 ) vascularity ; and 5 ) pain .
RESULTS	Wounds treated with cryopreserved CEAs remained durable and not prone to blistering after healing .
CONCLUSIONS	CEAs can be successfully cryopreserved for long-term storage .
CONCLUSIONS	Upon retrieval from storage , CEAs may be used to treat partial thickness wounds .

###24916884
BACKGROUND	We investigated the effect of resistance exercise intensity and exercise-induced metabolic stress on the activation of anabolic signaling and expression of myogenic genes in skeletal muscle .
METHODS	Ten strength-trained athletes performed high-intensity [ HI , 74 % of 1-repetition maximum ( RM ) ] , middle-intensity ( MI , 54 % 1RM ) , or middle-intensity ( 54 % 1RM ) no-relaxation exercise ( MIR ) .
METHODS	Kinase phosphorylation level and myogenic gene expression in muscle samples were evaluated before , 45 min , 5 h , and 20 h after exercise .
RESULTS	The lactate concentration in MI was approximately 2-fold lower than in the 2 other sessions , and was highest in MIR .
RESULTS	The phosphorylation level of extracellular kinase 1/2Thr202/Tyr204 after exercise was related to metabolic stress .
RESULTS	Metabolic stress induced a decrease in myostatin mRNA expression , whereas mechano-growth factor mRNA level depended on exercise intensity .
CONCLUSIONS	This study demonstrates that both intensity and exercise-induced metabolic stress can be manipulated to affect muscle anabolic signaling .

###7494563
BACKGROUND	Chemotherapy combinations that include an alkylating agent and a platinum coordination complex have high response rates in women with advanced ovarian cancer .
BACKGROUND	Such combinations provide long-term control of disease in few patients , however .
BACKGROUND	We compared two combinations , cisplatin and cyclophosphamide and cisplatin and paclitaxel , in women with ovarian cancer .
METHODS	We randomly assigned 410 women with advanced ovarian cancer and residual masses larger than 1 cm after initial surgery to receive cisplatin ( 75 mg per square meter of body-surface area ) with either cyclophosphamide ( 750 mg per square meter ) or paclitaxel ( 135 mg per square meter over 24 hours ) .
RESULTS	Three hundred eighty-six women met all the eligibility criteria .
RESULTS	Known prognostic factors were similar in the two treatment groups .
RESULTS	Alopecia , neutropenia , fever , and allergic reactions were reported more frequently in the cisplatin-paclitaxel group .
RESULTS	Among 216 women with measurable disease , 73 percent in the cisplatin-paclitaxel group responded to therapy , as compared with 60 percent in the cisplatin-cyclophosphamide group ( P = 0.01 ) .
RESULTS	The frequency of surgically verified complete response was similar in the two groups .
RESULTS	Progression-free survival was significantly longer ( P < 0.001 ) in the cisplatin-paclitaxel group than in the cisplatin-cyclophosphamide group ( median , 18 vs. 13 months ) .
RESULTS	Survival was also significantly longer ( P < 0.001 ) in the cisplatin-paclitaxel group ( median , 38 vs. 24 months ) .
CONCLUSIONS	Incorporating paclitaxel into first-line therapy improves the duration of progression-free survival and of overall survival in women with incompletely resected stage III and stage IV ovarian cancer .

###21059586
OBJECTIVE	To determine the feasibility and effectiveness of implementing an in-home expressive-writing intervention among breast cancer survivors living in urban and rural areas .
METHODS	Women who had completed radiation therapy were selected to participate in either expressive writing or a usual-care control condition .
METHODS	All materials were completed in the privacy of participants ' homes .
METHODS	Of the 57 breast cancer survivors recruited , 40 participated in the writing intervention .
METHODS	An additional 40 women were assigned to the control group .
METHODS	Participants completed measures of physical and psychological health at two time points prior to writing and at two follow-up time points three and nine months after writing .
METHODS	Participation rates and physical and psychological health .
RESULTS	Results showed that engaging in a single in-home writing session for women with breast cancer was feasible and showed significant improvements in physical and psychological health compared to control three months ( but not nine months ) after writing .
RESULTS	Although no difference was found in effectiveness of the intervention between women living in urban versus rural areas , rural women showed slightly higher participation rates .
CONCLUSIONS	The results illustrate the utility of employing remotely administered expressive-writing interventions for breast cancer survivors .
CONCLUSIONS	Healthcare professionals who wish to use writing to facilitate improvements in their patients may suggest that patients write at multiple time points , offer for the intervention to be completed at home , and target rural populations in particular .

###11919132
OBJECTIVE	To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients with type 1 diabetes .
METHODS	In a 52-week , double-blind , placebo-controlled , multicenter study , 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d. , in addition to existing insulin regimens .
METHODS	At week 20 , pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA ( 1c ) were < 1 % at week 13 .
METHODS	Of the 342 patients who completed the 52-week study , 236 individuals ( approximately 70 % ) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 microg pramlintide q.i.d.
RESULTS	Treatment with pramlintide led to a mean reduction in HbA ( 1c ) of 0.67 % from baseline to week 13 that was significantly ( P < 0.0001 ) greater than the placebo reduction ( 0.16 % ) , and a significant placebo-corrected treatment difference was sustained through week 52 ( P = 0.0071 ) .
RESULTS	The greater HbA ( 1c ) reduction was associated with an average weight loss , rather than weight gain , and was not accompanied by an increased overall event rate of severe hypoglycemia .
RESULTS	In the open-label extension , mean HbA ( 1c ) levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients who continued pramlintide treatment .
RESULTS	The most common adverse events reported by the pramlintide group were mild nausea and anorexia , which both occurred during the initial weeks of treatment and dissipated over time .
CONCLUSIONS	Mealtime pramlintide treatment as an adjunct to insulin improved long-term glycemic control without inducing weight gain or increasing the overall risk of severe hypoglycemia in patients with type 1 diabetes .

###14517661
OBJECTIVE	The current study was done to compare the effect of spinal and epidural anesthesia on surgical outcome measures of inguinal herniorrhaphy .
METHODS	Ninety-eight male patients undergoing inguinal hernia repair were randomized to either spinal ( SA ; n = 39 ) or epidural ( EA ; n = 59 ) anesthesia groups anesthetized with either glycosylated bupivacaine ( 20 mg ) or 0.5 % bupivacaine ( 100 mg ) .
METHODS	Anesthesia onset time ( AOT ) , postoperative stand-up time ( SUT ) , first pain sensation time ( FPT ) , operation time ( OT ) , analgesic requirement ( AR ) , hospital stay ( HS ) , visual analogue scores of pain ( VAS ) , per - and postoperative complications , and postanesthesia complications were recorded and compared with each other .
RESULTS	FPT was 6.6 + / - 0.6 h and 3.1 + / - 0.4 h and OT was 40 + / - 2 min and 33.1 + / - 1 min in the EA and SA groups , respectively ( p < 0.05 ) .
RESULTS	SUT was also longer in EA group .
RESULTS	VAS scores at 12 and 24 h were significantly higher in the EA group ( 28 + / - 4 mm and 24 + / - 5 mm in EA and 16 + / - 4 and 5 + / - 1 mm in SA ; P < 0.05 ) .
RESULTS	No statistically significant difference was found between the SA and EA groups with respect to the other outcome measures that were considered .
CONCLUSIONS	Spinal and epidural anesthesia show some differences from each other with respect to outcome measures such as OT , SUT , FPT , and 12 - and 24-h VAS scores .

###19832769
OBJECTIVE	The aim of this study was to compare ball and magnet attachments within implant-supported mandibular overdentures ( ISMOD ) using patient centred outcome measures .
OBJECTIVE	Our a priori hypothesis was that there is no difference in patient satisfaction between the two attachment types .
METHODS	In this within-subject crossover randomised clinical trial , edentulous patients were recruited to the study and completed a denture satisfaction questionnaire before having two implants placed in the intraforaminal region of the mandible .
METHODS	They were randomly assigned to receive an ISMOD retained by either ball or magnetic attachment .
METHODS	After 3 months satisfaction questionnaires were repeated before attachments were changed to the alternative design .
METHODS	After a further 3 months patients completed final questionnaires .
METHODS	Patients were asked to choose their preferred prostheses and record the most influential factors in their final choice .
METHODS	The outcome variables of patient satisfaction were compared between baseline and the two attachment types using non-parametric two-related sample tests ( Wilcoxon 's signed rank ) .
CONCLUSIONS	Sixteen patients completed the study .
CONCLUSIONS	Patient satisfaction improved significantly between baseline and the new prosthesis with each attachment type for all domains of satisfaction ( P < 0.05 ) .
CONCLUSIONS	Ball attachments provided greater satisfaction in the domains of general satisfaction , stability and ability to chew ( P < 0.05 ) .
CONCLUSIONS	Patients ' general satisfaction with ball attachment retained overdentures was greater than that for magnetic attachments ; however , both designs provide significantly greater satisfaction than conventional dentures .
CONCLUSIONS	In this study , the majority preferred to retain the ball attachment although one-third of patients actively chose the magnetic attachment .

###22085440
BACKGROUND	Most physical activity and nutrition interventions in children focus on the school setting ; however , evidence suggests that children are less active and have greater access to unhealthy food at home .
BACKGROUND	The aim of this pilot study was to examine the efficacy of a compulsory homework programme for increasing physical activity and healthy eating in children .
METHODS	The six-week ` Healthy Homework ' programme and complementary teaching resource was developed under the guidance of an intersectoral steering group .
METHODS	Eight senior classes ( year levels 5-6 ) from two diverse Auckland primary schools were randomly assigned into intervention and control groups .
METHODS	A total of 97 children ( 57 intervention , 40 control ) aged 9-11 years participated in the evaluation of the intervention .
METHODS	Daily step counts were monitored immediately before and after the intervention using sealed multiday memory pedometers .
METHODS	Screen time , sports participation , active transport to and from school , and the consumption of fruits , vegetables , unhealthy foods and drinks were recorded concurrently in a 4-day food and activity diary .
RESULTS	Healthy Homework resulted in a significant intervention effect of 2,830 steps.day-1 ( 95 % CI : 560 , 5,300 , P = 0.013 ) .
RESULTS	This effect was consistent between sexes , schools , and day types ( weekdays and weekend days ) .
RESULTS	In addition , significant intervention effects were observed for vegetable consumption ( 0.83 servings.day-1 , 95 % CI : 0.24 , 1.43 , P = 0.007 ) and unhealthy food consumption ( -0.56 servings.day-1 , 95 % CI : -1.05 , -0.07 , P = 0.027 ) on weekends but not weekdays , with no interactions with sex or school .
RESULTS	Effects for all other variables were not statistically significant regardless of day type .
CONCLUSIONS	Compulsory health-related homework appears to be an effective approach for increasing physical activity and improving vegetable and unhealthy food consumption in children .
CONCLUSIONS	Further research in a larger study is required to confirm these initial results .

###20506356
OBJECTIVE	To evaluate whether an everolimus-eluting stent ( EES ) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes .
BACKGROUND	Higher periprocedural myocardial infarction ( MI ) rates have been reported with the TAXUS EXPRESS ( 2 ) paclitaxel-eluting stent ( PES ) compared to the bare metal EXPRESS ( 2 ) stent due to more frequent side branch compromise , presumably attributable to the thickness of the stent/polymer on the PES .
METHODS	In the SPIRIT III trial , we identified 113 patients in the XIENCE V EES group and 63 patients in the TAXUS EXPRESS ( 2 ) PES group who met the criteria of having a lesion with a jailed side branch ( < 2 mm diameter , and < 50 % stenosis ) .
METHODS	Two-year clinical outcomes were evaluated .
RESULTS	A periprocedural increase in Creatine Kinase-MB > 1 upper normal level occurred in 9.0 % of EES compared to 29.7 % of PES patients with jailed side branches , P = 0.01 .
RESULTS	Through 2 years , major adverse cardiac events ( MACE ; cardiac death , MI , or target lesion revascularization [ TLR ] ) occurred in 6.8 % of EES and 19.0 % of PES jailed side branch patients ( P = 0.03 ) , with numerically lower rates of MI ( 2.9 % vs. 10.3 % , P = 0.07 ) and TLR ( 3.9 % vs. 10.3 % , P = 0.17 ) in the EES group , with comparable rates of cardiac death ( 1.9 % vs. 1.7 % , P = 1.00 ) .
CONCLUSIONS	In this post-hoc analysis of the SPIRIT III RCT , patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs .
CONCLUSIONS	2010 Wiley-Liss , Inc. .

###15967861
BACKGROUND	Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality .
BACKGROUND	The aim of this study was to evaluate the usefulness of fenoldopam , a specific agonist of the dopamine-1 receptor , in patients at high risk of perioperative renal dysfunction .
RESULTS	A prospective single-center , randomized , double-blind trial was performed after local ethical committee approval and after written consent was obtained from 80 patients undergoing cardiac surgery .
RESULTS	Patients received either fenoldopam at 0.05 microg/kg per minute or dopamine at 2.5 microg/kg per minute after the induction of anesthesia for a 24-hour period .
RESULTS	All these patients were at high risk of perioperative renal dysfunction as indicated by Continuous Improvement in Cardiac Surgery Program score > 10 .
RESULTS	Primary end point was defined as 25 % creatinine increase from baseline levels after cardiac surgery .
RESULTS	The 2 groups ( fenoldopam versus dopamine ) were homogeneous cohorts , and no difference in outcome was observed .
RESULTS	Acute renal failure was similar : 17 of 40 ( 42.5 % ) in the fenoldopam group and 16 of 40 ( 40 % ) in the dopamine group ( P = 0.9 ) .
RESULTS	Peak postoperative serum creatinine level , intensive care unit and hospital stay , and mortality were also similar in the 2 groups .
CONCLUSIONS	Despite an increasing number of reports of renal protective properties from fenoldopam , we observed no difference in the clinical outcome compared with dopamine in a high-risk population undergoing cardiac surgery .

###23446198
BACKGROUND	An easy-to-administer tool for predicting response to antipsychotic treatment could improve the acute management of patients with schizophrenia .
BACKGROUND	We assessed whether a patient 's perception of medication benefit early in treatment could predict subsequent response or nonresponse to continued use of the same treatment .
METHODS	This post hoc analysis used data from a randomized , open-label trial of antipsychotics for treatment of schizophrenia in which attitudes about medication adherence were assessed after two weeks of antipsychotic treatment using the Rating of Medication Influences ( ROMI ) scale .
METHODS	The analysis included 439 patients who had Positive and Negative Syndrome Scale ( PANSS ) and ROMI scale data at Weeks 2 and 8 .
METHODS	Scores on the ROMI subscale Perceived Medication Benefit factor were used to predict subsequent antipsychotic response at Week 8 , defined as a .20 % reduction from baseline on the PANSS .
METHODS	Logistic regression was used to identify a cut-off score for the Perceived Medication Benefit factor that could accurately identify antipsychotic responders vs. nonresponders at Week 8 .
RESULTS	A score of .2.75 ( equal to a mean subscale score of .11.00 ) on the ROMI scale Perceived Medication Benefit factor at Week 2 predicted response at Week 8 with high specificity ( 72 % ) and negative predictive value ( 70 % ) , moderate sensitivity ( 44 % ) and positive predictive value ( 47 % ) , and with a 38 % misclassification rate .
CONCLUSIONS	A brief assessment of the patient 's perception of medication benefit at two weeks into treatment appears to be a good predictor of subsequent response and nonresponse after eight weeks of treatment with the same antipsychotic .

###11316092
OBJECTIVE	To measure the effect on intraocular pressure ( IOP ) for 24 hours after repeated administration of the fixed combination of latanoprost 0.005 % and timolol 0.5 % .
METHODS	A randomized , double-masked placebo-controlled crossover study including 20 patients with ocular hypertension was carried out .
METHODS	Patients were randomized to treatment with the fixed combination of latanoprost and timolol or with placebo .
METHODS	The eyedrop was taken at 8 AM .
METHODS	After 2 weeks of treatment , the patients were hospitalized , and the IOP was measured at 8 AM , and thereafter every other hour until midnight , and also at 3 AM , 6 AM , and 8 A.M.
METHODS	After a washout period of 4 weeks , they switched to the other eyedrop , and after 2 weeks of treatment were hospitalized and the IOP measurements were repeated at the same intervals .
RESULTS	The mean 24-hour IOP was 14.7 + / - 0.3 mm Hg ( mean + / - standard error of the mean ) for latanoprost and timolol and 19.4 + / - 0.3 mm Hg for placebo .
RESULTS	This corresponds to a significant IOP difference of 4.7 + / - 0.4 mm Hg ( 95 % confidence interval 3.8-5 .8 ; P < 0.001 ) between the two treatments in favor of the combination .
RESULTS	At all measured time points , except at 3 AM , the mean IOP was lower with latanoprost and timolol than with placebo .
RESULTS	During daytime measurements the mean IOP was 13.9 + / - 0.7 mm Hg for the fixed combination and 19.5 + / - 0.7 mm Hg for the placebo .
RESULTS	Corresponding figures at nighttime were 16.1 + / - 0.7 mm Hg and 19.2 + / - 0.7 mmHg , respectively .
CONCLUSIONS	The fixed combination of latanoprost and timolol significantly reduced IOP after administration once daily for 2 weeks in patients with ocular hypertension .
CONCLUSIONS	A reduction of IOP during a 24-hour period was seen , with a greater IOP reduction during daytime compared with nighttime .
CONCLUSIONS	The fixed combination applied once daily could be a convenient alternative to concomitant therapy with its individual components .

###24636118
OBJECTIVE	To integrate group-based lifestyle sessions ( GBLS ) within prenatal care for gestational weight gain ( GWG ) management .
METHODS	In Study 1 , participants attended GBLS during prenatal care visits .
METHODS	Participants in Study 2 attended off-site GBLS whereby care providers were asked to discuss the program with patients .
METHODS	Process and outcome evaluation were conducted through a mixed-methods approach .
RESULTS	In both pre-experimental feasibility studies , data provide preliminary support for GBLS ( eg , positive care provider and patient feedback , weight gain patterns ) as well as highlight areas for future research ( eg , lack of GWG management discussions , preference for GBLS location ) .
CONCLUSIONS	GBLS represents a promising approach to GWG management .
CONCLUSIONS	Future research should assess the generalizability , sustainably , and compatibility of GBLS within prenatal care .

###23983090
OBJECTIVE	To determine the additional effects of transcutaneous electrical nerve stimulation ( TENS ) for knee osteoarthritis ( OA ) when combined with a group education and exercise program ( knee group ) .
METHODS	The study was a randomized , sham-controlled clinical trial .
METHODS	Patients referred for physiotherapy with suspected knee OA ( confirmed using the American College of Rheumatology clinical criteria ) were invited .
METHODS	Exclusion criteria included comorbidities preventing exercise , previous TENS experience , and TENS contraindications .
METHODS	Prospective sample size calculations required 67 participants in each trial arm .
METHODS	A total of 224 participants ( mean age 61 years , 37 % men ) were randomized to 3 arms : TENS and knee group ( n = 73 ) , sham TENS and knee group ( n = 74 ) , and knee group ( n = 77 ) .
METHODS	All patients entered an evidence-based 6-week group education and exercise program ( knee group ) .
METHODS	Active TENS produced a `` strong but comfortable '' paraesthesia within the painful area and was used as much as needed during the 6-week period .
METHODS	Sham TENS used dummy devices with no electrical output .
METHODS	Blinded assessment took place at baseline and 3 , 6 , 12 , and 24 weeks .
METHODS	The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale at 6 weeks .
METHODS	Secondary outcomes included WOMAC pain , stiffness , and total scores ; extensor muscle torque ; global assessment of change ; exercise adherence ; and exercise self-efficacy .
METHODS	Data analysis was by intent to treat .
RESULTS	All outcomes improved over time ( P < 0.05 ) , but there were no differences between trial arms ( P > 0.05 ) .
RESULTS	All improvements were maintained at 24-week followup .
CONCLUSIONS	There were no additional benefits of TENS , failing to support its use as a treatment adjunct within this context .

###14653830
BACKGROUND	Small bowel bacterial overgrowth is common in Crohn 's disease but its treatment is not clearly defined .
BACKGROUND	Metronidazole and ciprofloxacin are effective antibiotics in active Crohn 's disease .
OBJECTIVE	To investigate the efficacy of metronidazole and ciprofloxacin in the treatment of bacterial overgrowth in patients with Crohn 's disease .
METHODS	We performed the lactulose breath test in 145 consecutive patients affected by Crohn 's disease .
METHODS	Patients positive to the lactulose breath test underwent a glucose breath test to confirm the overgrowth .
METHODS	These patients were randomized in two treatment groups : metronidazole 250 mg t.d.s. ( Group A ) and ciprofloxacin 500 mg b.d. ( Group B ) , both orally for 10 days .
METHODS	The glucose breath test was repeated at the end of treatment .
METHODS	The clinical outcome after therapy was also recorded .
RESULTS	Bacterial overgrowth was present in 29 patients ( 20 % ) .
RESULTS	Breath test normalization occurred in 13 out of 15 patients treated by metronidazole and in all 14 patients treated by ciprofloxacin ( P = ns ) .
RESULTS	In both groups antibiotic treatment induced an improvement of intestinal symptoms : bloating ( Group A 85 % and Group B 83 % ) , stool softness ( 44 % and 50 % ) , and abdominal pain ( 50 % and 43 % ) .
CONCLUSIONS	Small bowel bacterial overgrowth is a frequent condition in Crohn 's disease which can be effectively treated by metronidazole or ciprofloxacin .

###15191483
BACKGROUND	No data are currently available to assess the relative merits of breast binder or bra following breast surgery .
METHODS	A randomized controlled study was undertaken to compare a breast binder with a bra postoperatively for patients undergoing lumpectomies , partial mastectomies and total mastectomies .
RESULTS	Fifty-eight patients were included in the study .
RESULTS	Six different parameters were compared and the bra was found better on all criteria ; a small group of patients who initially used a binder and then , for a second procedure , used a bra , found the bra more comfortable .
CONCLUSIONS	Postoperative discomfort can be decreased by using a well-fitting bra rather than a breast binder .

###12848782
OBJECTIVE	We assessed whether montelukast or formoterol provides additive effects to asthmatics not controlled on inhaled corticosteroids , by studying patients who were considered to be genetically susceptible to beta2-receptor down regulation and subsensitivity , and who expressed the homozygous glycine-16 beta2-receptor genotype .
METHODS	Fifteen corticosteroid-treated , mild to moderate persistent asthmatics received montelukast 10 mg once daily or formoterol 9 micro g twice daily for 2 weeks , separated by a 2-week placebo run-in and washout , in a double-blind , double-dummy , randomized crossover design .
METHODS	Bronchoprotection against adenosine monophosphate ( AMP ) challenge ( primary endpoint ) , spirometry and blood eosinophils were measured at trough after placebo , first and last doses .
RESULTS	For AMP PC20vs placebo , there were sustained significant ( P < 0.05 ) doubling dilution improvements following first ( 1.1 ; 95 % CI 0.4 , 1.9 ) and last ( 1.0 ; 95 % CI 0.3 , 1.8 ) doses of montelukast , and following first ( 1.3 ; 95 % CI 0.1 , 2.6 ) but not last ( 0.3 ; 95 % CI -0.9 , 1.6 ) doses of formoterol .
RESULTS	Blood eosinophils ( x 10 ( 6 ) l ( -1 ) ) were significantly ( P < 0.05 ) suppressed after the last dose of montelukast ( -71 ; 95 % CI -3 , -140 ) compared with placebo , while formoterol exhibited a nonsignificant rise ( 20 ; 95 % CI -92 , 132 ) .
RESULTS	Neither treatment significantly improved FEV1 , FEF25-75 or PEF after 2 weeks .
CONCLUSIONS	In genetically susceptible patients with the homozygous glycine-16 genotype , montelukast , but not formoterol , conferred sustained anti-inflammatory properties in addition to inhaled corticosteroid , which were dissociated from changes in lung function after 2 weeks .
CONCLUSIONS	Thus , assessing lung function may miss potentially beneficial anti-inflammatory effects of montelukast when used as add-on therapy .

###20496307
BACKGROUND	The local application of drugs is an efficient method for treating diseases of the external eye .
BACKGROUND	However , some active substances can also cause a chronic toxic reaction at the ocular surface .
BACKGROUND	No results from clinical experiments on the local tolerance of kanamycin which would meet the requirements of evidence-based medicine are as yet available .
METHODS	Thus , the cytomorphological processes of the treatment with kanamycin were examined in a prospective randomised placebo-controlled double blind cross-over study .
METHODS	The effect of the topical application ( 5 times a day for 7 days ) of Kanamycin POS eye ointment on the conjunctival epithelial barrier was studied in comparison with an eye ointment base ( placebo ) in 25 healthy subjects .
METHODS	To detect cytopathological microchanges of the epithelium , we carried out a standardised impression cytology ( primary compatibility parameter ) .
METHODS	Biomicroscopy , Schirmer II test and non-invasive measurement of the break-up-time ( tearscope ) were also examined .
METHODS	The subjective compatibility parameters ( itching , tearing , foreign body sensation , burning sensation , mucus ) were measured on a 0 - 10 visual analogue scale .
RESULTS	The cytological findings of 23 subjects were included in the final evaluation of the study .
RESULTS	The impression cytology did not reveal a different effect of kanamycin ophthalmic ointment on the conjunctival ocular surface in comparison with the placebo .
RESULTS	Only in one subject was a marked shift found in the nuclear-cytoplasmic ratio after application of verum .
RESULTS	No signs of increased apoptosis ( `` snake-like chromatin '' ) were found at the conjunctival epithelial barrier .
RESULTS	The mean goblet cell count was 109 goblet cells per mm ( 2 ) .
RESULTS	No significant reduction of the goblet cell density was found in any treatment group .
RESULTS	Among the subjective compatibility parameters , only the mean for itching constantly remained above the placebo group after application of kanamycin .
RESULTS	Statistically significant differences were not found by the Wilcoxon test .
CONCLUSIONS	In contrast to the clinical experience with the systematic application of kanamycin , the standardised evaluation of this study confirmed the very good topical tolerability of the tested kanamycin eye ointment .
CONCLUSIONS	In view of the continuing clinically relevant aspect of the availability of a wide spectrum of antibiotics to avoid the development of resistance while at the same time keeping within what is reasonable economically , Kanamycin POS for topical application supplements the options of ophthalmological antibacterial chemotherapy .

###14738791
BACKGROUND	Despite available treatment with intravenous immunoglobulin ( IVIg ) , morbidity and mortality are considerable in patients with Guillain-Barr syndrome ( GBS ) .
BACKGROUND	Our aim was to assess whether methylprednisolone , when taken with IVIg , improves outcome when compared with IVIg alone .
METHODS	We did a double-blind , placebo-controlled , multicentre , randomised study , to which we enrolled patients who were unable to walk independently and who had been treated within 14 days after onset of weakness with IVIg ( 0.4 g/kg bodyweight per day ) for 5 days .
METHODS	We assigned 233 individuals to receive either intravenous methylprednisolone ( 500 mg per day ; n = 116 ) or placebo ( n = 117 ) for 5 days within 48 h of administration of first dose of IVIg .
METHODS	Because age is an important prognostic factor , we split treatment groups into two age-groups-ie , younger than age 50 years , or 50 years and older .
METHODS	Our primary outcome was an improvement from baseline in GBS disability score of one or more grades 4 weeks after randomisation .
METHODS	Analysis was by intention to treat .
RESULTS	We analysed 225 patients .
RESULTS	GBS disability scores increased by one grade or more in 68 % ( 76 of 112 ) of patients in the methylprednisolone group and in 56 % ( 63 of 113 ) of controls ( odds ratio [ OR ] 1.68 , 95 % CI 0.97-2 .88 ; p = 0.06 ) .
RESULTS	After adjustment for age and degree of disability at entry , treatment OR was 1.89 ( 95 % CI 1.07-3 .35 ; p = 0.03 ) .
RESULTS	Side-effects did not differ greatly between groups .
CONCLUSIONS	We noted no significant difference between treatment with methylprednisolone and IVIg and IVIg alone .
CONCLUSIONS	Because of the relevance of prognostic factors and the limited side-effects of methylprednisolone , the potential importance of combination treatment with the drug and IVIg , however , warrants further investigation .

###7658483
BACKGROUND	The kinetics of colorectal epithelial cell proliferation is altered in patients at increased risk for colon cancer .
BACKGROUND	Calcium administration ameliorates such proliferative changes in rodents .
BACKGROUND	Findings in preliminary clinical trials have suggested similar effects in humans .
OBJECTIVE	A randomized , double-blind , placebo-controlled , clinical trial was designed to determine whether calcium supplementation will reduce the colorectal epithelial cell proliferation rate and normalize the distribution of proliferating cells within colorectal crypts ( i.e. , shift the zone of proliferation from the entire crypt to the lower 60 % of the crypt , which is thought to be the normal proliferative zone of the crypt ) in patients with sporadic adenomas .
METHODS	Sporadic adenoma patients ( n = 193 ) were treated with placebo ( n = 66 ) , 1.0 g calcium ( n = 64 ) , or 2.0 g calcium ( n = 63 ) daily for 6 months .
METHODS	Rectal mucosa biopsy specimens were obtained at base line and at 1 - , 2 - , and 6-month follow-up .
METHODS	Cell proliferation was measured by detection of S-phase-associated proliferating cell nuclear antigen by immunohistochemical methods .
METHODS	The cell proliferation rate , called labeling index ( LI ) , was calculated as the proportion of labeled cells in the crypts .
METHODS	The deviation of the proliferative zone from the normal location in the lower 60 % of the crypt was calculated as the proportion of labeled cells in the upper 40 % of the crypt , called distributional index ( phi h ) .
METHODS	The effects of calcium treatment on the LI and phi h were expressed as relative effects -- ( calcium follow-up/calcium base line ) / ( placebo follow-up/placebo base line ) .
METHODS	Calculations and inference testing of the relative effects were accomplished using a repeated-measures mixed model on log-transformed LI and phi h values .
METHODS	All statistical tests were two-sided .
RESULTS	Scorable biopsy specimens were obtained on 170 patients at base line , 164 at 1 month , 161 at 2 months , and 163 at 6 months .
RESULTS	The difference in the change in the LI between the combined calcium groups and the placebo group was insignificant , with a relative effect of calcium versus placebo of 0.97 ( P = .87 ) .
RESULTS	However , for the phi h , the relative effect of calcium versus placebo was 0.50 ( P = .05 ) in the combined calcium groups , 0.56 ( P = .16 ) in the 1.0-g calcium group , and 0.44 ( P = .05 ) in the 2.0-g calcium group .
CONCLUSIONS	Calcium supplementation normalizes the distribution of proliferating cells without affecting the proliferation rate in the colorectal mucosa of sporadic adenoma patients .
CONCLUSIONS	These results support further study of whether alterations in colon cell proliferative kinetics represent true intermediate steps in colon carcinogenesis that can be used to investigate the etiology and prevention of , and whether a higher calcium consumption can reduce the risk of , colon cancer .

###25739878
BACKGROUND	Chikungunya is an emerging arthropod-borne disease that has spread from tropical endemic areas to more temperate climates of the USA and Europe .
BACKGROUND	However , no specific treatment or preventive measure is yet available .
BACKGROUND	We aimed to investigate the immunogenicity and safety of a live recombinant measles-virus-based chikungunya vaccine .
METHODS	We did a randomised , double-blind , placebo-controlled , active-comparator , phase 1 , dose-escalation study at one centre in Vienna , Austria .
METHODS	Healthy men and women aged 18-45 years with no comorbidities were randomly assigned , by computer-generated block randomisation ( block size of 14 ) , to receive either one of three escalating doses of the measles-virus-based candidate vaccine ( low dose [ 1510 ( 4 ) median tissue culture infection doses ( TCID50 ) per 005 mL ] , medium dose [ 7510 ( 4 ) TCID50 per 025 mL ] , or high dose [ 3010 ( 5 ) TCID50 per 10 mL ] ) , or the active comparator-Priorix .
METHODS	Participants were additionally block-randomised to receive a booster injection on either day 28 or day 90 after the first vaccination .
METHODS	Participants and study investigators were masked to group allocation .
METHODS	The primary endpoint was the presence of neutralising anti-chikungunya antibodies on day 28 , as assessed by 50 % plaque reduction neutralisation test .
METHODS	Analysis was by intention to treat and per protocol .
METHODS	This trial is registered with EudraCT , number 2013-001084-23 .
RESULTS	Between Nov 22 , 2013 , and Feb 25 , 2014 , we randomly assigned 42 participants to receive the low dose ( n = 12 ) , the medium dose ( n = 12 ) , or the high dose ( n = 12 ) of the measles-virus-based candidate vaccine , or Priorix ( n = 6 ) , of whom 36 participants ( 86 % ; n = 9 , n = 12 , n = 10 , n = 5 , respectively ) were included in the per-protocol population .
RESULTS	The candidate vaccine raised neutralising antibodies in all dose cohorts after one immunisation , with seroconversion rates of 44 % ( n = 4 ) in the low-dose group , 92 % ( n = 11 ) in the medium-dose group , and 90 % ( n = 10 ) in the high-dose group .
RESULTS	The immunogenicity of the candidate vaccine was not affected by pre-existing anti-measles immunity .
RESULTS	The second vaccination resulted in a 100 % seroconversion for all participants in the candidate vaccine groups .
RESULTS	The candidate vaccine had an overall good safety profile , and the rate of adverse events increased with vaccine dose and volume .
RESULTS	No vaccination-related serious adverse events were recorded .
CONCLUSIONS	The live recombinant measles-virus-based chikungunya vaccine had good immunogenicity , even in the presence of anti-vector immunity , was safe , and had a generally acceptable tolerability profile .
CONCLUSIONS	This vaccine is the first promising measles-virus-based candidate vaccine for use in human beings .
BACKGROUND	Themis Bioscience GmBH .

###15998657
BACKGROUND	Transplant recipients have elevated oxidative stress , which has prompted suggestions that supplementary antioxidants may be beneficial .
BACKGROUND	However , only a small number of clinical trials have investigated antioxidant supplementation in transplant recipients , with very few data on their effects on patients ' immunosuppressive therapy .
METHODS	A randomized placebo-controlled single-blind crossover trial was conducted in 10 renal transplant recipients ( RTRs ) taking cyclosporin A ( CsA ) as part of their immunosuppressive therapy .
METHODS	Each phase of the trial lasted 6 months , with a 6 month wash-out period in between .
METHODS	During one of the phases , patients consumed a tablet twice per day which delivered 400 IU/day of vitamin E , 500 mg/day of vitamin C and 6 mg/day of beta-carotene .
RESULTS	During antioxidant supplementation , there was no change in CsA dose .
RESULTS	Antioxidant supplementation resulted in a significant decrease ( P < 0.05 ) in blood trough CsA by 24 % ( mean + / - SD , pre - 127.3 + / -38.9 , post - 97.2 + / -30.7 microg/ml ) compared with no change while taking the placebo ( pre - 132.2 + / -50.6 , post - 138.6 + / -56.0 microg/ml ) .
RESULTS	The glomerular filtration rate was significantly ( P < 0.05 ) improved by 12 % during antioxidant supplementation ( pre - 66.9 + / -20.7 , post - 75.0 + / -20.1 ml/min/1 .72 m2 ) , with no change during the placebo phase ( pre - 66.8 + / -11.8 , post - 66.7 + / -16.1 ml/min/1 .72 m2 ) .
RESULTS	There were no significant differences ( P > 0.05 ) in markers of oxidative stress ( malondialdehyde , susceptibility of plasma to oxidation ) or plasma antioxidant enzymes .
CONCLUSIONS	In CsA-treated RTRs , antioxidant supplementation decreased blood CsA , which may affect adequacy of immunosuppression .

###9924299
OBJECTIVE	Lodoxamide tromethamine and N-acetyl-aspartyl glutamic acid ( NAAGA ) are mast cell stabilisers , both of which have been shown to be effective in the treatment of allergic conjunctivitis .
OBJECTIVE	The aim of this study was to compare the two compounds in patients with common ocular allergic disorders .
METHODS	73 patients participated in a double masked , randomised multicentre study .
METHODS	Diagnoses were chronic allergic conjunctivitis , vernal conjunctivitis , seasonal and atopic conjunctivitis .
METHODS	36 patients were treated with lodoxamide 0.1 % and 37 with NAAGA 4.9 % , the drops being instilled four times daily for up to 56 days .
RESULTS	The overall opinion of the physicians and the patients was in favour of lodoxamide at day 10 of the study .
RESULTS	At this time , 86 % of lodoxamide treated and 49 % of NAAGA treated patients considered they had improved .
RESULTS	The patients ' opinion favoured lodoxamide at day 28 and both physicians ' and patients ' evaluations were in favour of lodoxamide at day 42 .
RESULTS	Evaluation of signs and symptoms indicated superiority of lodoxamide at days 42 and 56 .
RESULTS	Both treatments were well tolerated .
CONCLUSIONS	While both lodoxamide and NAAGA treatments are associated with clinical improvements in patients with allergic conjunctivitis , lodoxamide may have an earlier onset of action .

###15772567
OBJECTIVE	To assess the effects of 6 weeks of treatment with soy supplements on mood , menopausal symptoms , and cognition in postmenopausal women not taking other forms of hormone therapy .
METHODS	In a double-blind , placebo-matched parallel groups study , 50 postmenopausal women ( aged 51-66 y ) were randomly allocated to receive daily treatment with a soy supplement ( Novasoy , 60 mg total isoflavone equivalents/day ) or matching placebo capsules .
METHODS	They were tested at baseline before treatment began and after 6 weeks of treatment in tests of attention , memory , and frontal lobe function , and completed questionnaires to assess sleepiness , mood , and menopausal symptoms .
RESULTS	After 6 weeks of treatment , there was a significant ( P < 0.02 ) reduction in somatic menopausal symptoms in the group taking soy supplements , but there were no other significant effects of soy on menopausal symptoms or mood .
RESULTS	On the test of nonverbal short-term memory , the soy group showed greater improvement than the placebo group ( P < 0.03 ) , but there were no effects of soy on long-term memory , category generation , or sustained attention .
RESULTS	However , the soy treatment produced significantly better performance on the two tests of frontal lobe function , those of mental flexibility ( simple rule reversal , P < 0.05 ; complex rule reversal , P < 0.03 ) and of planning ability ( P < 0.05 ) .
CONCLUSIONS	The results suggest that the main improvement after 6 weeks of soy supplementation was in frontal lobe function .
CONCLUSIONS	Significant improvements in the same three measures of frontal lobe function were previously found after 12 weeks of soy supplements in postmenopausal women .
CONCLUSIONS	The effects of soy on memory seem less robust .

###21110411
OBJECTIVE	We assessed the exercise tolerance and cardiorespiratory responses during 2-month weight-loss programmes using the 6-minute walking test ( 6MWT ) in obese children .
METHODS	Twenty-eight male obese children were randomly assigned to either a control group ( C ) , an energy restriction group ( R ) , an exercise training at maximum lipid-oxidation ( LIPOXmax ) group ( E ) , or an energy restriction/training group ( RE ) .
METHODS	The body composition , the submaximal incremental cycling exercise , and the 6MWT were performed before and after the 2-month programme .
RESULTS	After the programme , RE group showed a significant improvement of body composition ( body weight reduced by 6.3 1.5 kg , p < 0.01 ) , and an increase of 6-minute walking distance ( 6MWD ) ( +13.7 % , p < 0.01 ) .
RESULTS	Similarly , maximum oxygen uptake calculated according to the American College of Science Medicine guideline ( VO ( 2max ) ACSM ) and VO ( 2max ) predicted from 6MWD were respectively higher ( +12.9 % and +10.0 % , p < 0.01 ) than the R or E groups .
RESULTS	Bland-Altman analysis highlighted an agreement of these two methods of VO ( 2max ) measurement .
RESULTS	Moreover , in all participants the 6MWD was significantly correlated with VO ( 2max ) ACSM and LIPOXmax ( r = 0.77 , p < 0.001 and r = 0.67 , p < 0.01 ; respectively ) before the programme as well as their changes in percentage over the programme ( r = 0.85 and r = 0.86 , p < 0.0001 ; respectively ) .
CONCLUSIONS	We concluded that a 2-month weight-loss programme including energy restriction and exercise training targeted at LIPOXmax improved body composition and cardiorespiratory tolerance in obese children .
CONCLUSIONS	Furthermore , the 6MWT could be considered as a useful and reliable tool for the assessment and the follow-up of cardiorespiratory responses during weight-loss programme in obese children .

###12802653
BACKGROUND	Laparoscopic hernia repair excites controversy because its benefits are debatable and critics claim it is attended by serious complications .
BACKGROUND	The one group of patients in whom benefits may outweigh the perceived disadvantages are those with bilateral or recurrent inguinal hernias .
METHODS	One hundred twenty patients with bilateral or recurrent hernias were randomized to either laparoscopic transabdominal preperitoneal ( TAPP ) or open mesh repair .
METHODS	Patients completed a well-being questionnaire prior to and following surgery together with a visual analog pain score .
METHODS	Patients were followed up clinically at 1 and 3 months and thereafter by their general practitioner .
RESULTS	Age and sex distribution was similar in the two groups .
RESULTS	Laparoscopic TAPP hernia was quicker ( 40 vs 55 min ; p < 0.001 ) , less painful ( visual analog pain score , 2.8 vs 4.3 ; p = 0.003 ) and allowed earlier return to work ( 11 vs 42 days ; p < 0.001 ) compared to open mesh repair .
CONCLUSIONS	This trial demonstrates that laparoscopic hernia repair via the TAPP route offers significant benefit to patients undergoing bilateral or recurrent inguinal hernia repair .

###19293290
OBJECTIVE	To determine the acceptability and clinical application of two recently developed goal-setting interventions ( Goal Management Training and Identity Oriented Goal Training ) in people with traumatic brain injury .
METHODS	A three parallel group , randomized controlled pilot study .
METHODS	Inpatient and community rehabilitation facilities .
METHODS	Thirty-four people with moderate to severe traumatic brain injury ( Goal Management Training , n = 12 ; Identity Oriented Goal Training , n = 10 ; usual care , n = 12 ) and their rehabilitation clinicians .
METHODS	For both Goal Management Training and Identity Oriented Goal Training participants met face to face with their key worker weekly over a period of 6-8 weeks , during which time the key worker worked to engage them in goal setting and goal performance using the strategy prescribed by their group allocation .
METHODS	Usual care was provided to the other participants .
METHODS	Largely qualitative using observation , individual interviews and focus groups .
METHODS	Participants also completed a Goal Attainment Scale at baseline , post intervention and at three months follow-up .
RESULTS	Both approaches were acceptable to the majority of participants with many reporting improved mood and goal attainment .
RESULTS	Clinicians found working in a different way with patients both challenging and rewarding , with both experimental approaches enhancing a focus on the person 's own goals .
RESULTS	Identity Oriented Goal Training seemed particularly helpful in engaging people in the goal-setting process while Goal Management Training appeared particularly helpful in providing a structured framework for error prevention in attempting goal performance .
CONCLUSIONS	These theoretically informed approaches to goal setting showed promise but were time intensive and at times difficult for practitioners to utilize .

###19166566
BACKGROUND	Women who do not receive regular mammograms are more likely than others to have breast cancer diagnosed at an advanced stage .
OBJECTIVE	To examine predisposing and enabling factors associated with mammography use among Hispanic and non-Hispanic White women .
METHODS	Baseline data were used from a larger study on cancer prevention in rural Washington state .
METHODS	In a sample of 20 communities , 537 women formed the sample for this study .
METHODS	The main outcomes were ever having had a mammogram and having had a mammogram within the past 2 years .
RESULTS	Reporting ever having had a mammogram was inversely associated with lack of health insurance ( OR = 0.37 , 95 % CI : 0.16-0 .84 ) , ages under 50 years ( OR = 0.23 , 95 % CI : 0.12-0 .45 ) , high cost of exams ( OR = 0.48 , 95 % CI : 0.27-0 .87 ) , and lack of mammography knowledge ( OR = 0.16 , 95 % CI : 0.07-0 .37 ) , while increasing education levels were positively associated ( OR = 1.72 , 95 % CI : 1.09-2 .70 ) .
RESULTS	Reporting mammography use within the past 2 years was inversely associated with ages under 50 years ( OR = 0.49 , 95 % CI : 0.27-0 .88 ) and over 70 years ( OR = 0.47 , 95 % CI : 0.24-0 .94 ) , lack of health insurance ( OR = 0.23 , 95 % CI : 0.10-0 .50 ) , and high cost of exams ( OR = 0.55 , 95 % CI : 0.35-0 .87 ) .
CONCLUSIONS	Continued resources and programs for cancer screening are needed to improve mammography participation among women without health insurance or low levels of education .

###9927017
OBJECTIVE	This study examined the relationships among diet , exercise intensity , and breast milk composition in lactating women .
METHODS	Twelve lactating women were randomly assigned to either a high ( N = 6 ; 5.03 g carbohydrate ( CHO ) x kg body mass ( BM ) ( -1 ) ) or moderate ( N = 6 ; 3.89 g CHO x kg BM ( -1 ) ) carbohydrate diet .
METHODS	Milk and blood samples were collected before and after a nonexercise session ( control ) and maximal , lactic acid-threshold ( LAT ) , and 20 % below the LAT ( LAT-20 ) intensities .
RESULTS	The 30-min exercise LAT bout was more stressful than the 30-min LAT-20 bout ( rating of perceived exertion ( RPE ) = 15 vs 12 , respectively , P < 0.05 ) .
RESULTS	Milk LA was significantly higher at 0 min following maximal exercise in the high and moderate CHO groups ( 1.27 + / -0.56 and 1.52 + / -0.49 mM , respectively ) and following LAT exercise ( 0.19 + / -0.16 and 0.25 + / -0.12 mM , respectively ) , when compared with the control session ( 0.08 + / -0.03 and 0.09 + / -0.05 mM , respectively ) .
RESULTS	This was not observed following the LAT-20 exercise in the high and moderate CHO groups ( 0.11 + / -0.04 and 0.12 + / -0.08 mM , respectively ) .
RESULTS	Elevated milk LA persisted in the 30-min collection point after maximal exercise only .
RESULTS	There was no significant effect of dietary treatment on milk or blood LA at any of the collection points .
CONCLUSIONS	In lactating women whose caloric needs are being met : 1 ) dietary CHO intake , within a practical range , does not influence LA levels in breast milk at rest or after exercise ; 2 ) LA appearance in the milk is a function of exercise intensity ; and 3 ) moderate intensity exercise ( RPE = 12 ) will not increase breast milk LA levels .

###22510506
OBJECTIVE	Lung cancer is the most common type among all malignant tumors , bringing huge pain and mood disorders to patients suffering from it .
OBJECTIVE	This study aims to evaluate the effect of the Feiji Decoction for soothing the liver combined with psychotherapy for depression and anxiety on patients with primary lung cancer .
OBJECTIVE	It also aims to further explore the relationship between depression and anxiety .
METHODS	A total of 118 patients with primary non-small cell lung cancer were randomly divided into two groups .
METHODS	The combined therapy group consisted of 57 patients who were treated with Feiji Decoction for soothing the liver and psychotherapy combined with chemotherapy .
METHODS	The control group consisted of 61 patients who were treated with chemotherapy only .
METHODS	Both groups were observed for two treatment courses .
METHODS	The Zung Self-reported Depression Scales ( SDS ) and Zung Self-reported Anxiety Scales ( SAS ) were used to assess the patients ' psychology status in both groups before and after treatment scales .
RESULTS	After treatment , the depression and anxiety scores of the therapy group remarkably decreased compared with scores before treatment , indicating a statistical significance ( P < 0.01 ) .
RESULTS	In comparison , after treatment , the depression and anxiety scores of the control group significanfly increased compared with scores before treatment , indicating a statistical significance ( P < 0.01 ) as well .
RESULTS	The depression and anxiety scores of the therapy group significanfly decreased compared with scores of the control group , showing statistical significance ( P < 0.01 ) .
RESULTS	Thus , depression and anxiety score has a close co-relationship , showing significant positive correlation ( P < 0.01 ) .
CONCLUSIONS	Feiji Decoction for soothing the liver combined with psychotherapy can alleviate depression and anxiety in patients with primary lung cancer .
CONCLUSIONS	This therapy has good clinical therapeutic effect .

###24055998
BACKGROUND	Acute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis ( CF ) .
BACKGROUND	Pulmonary exacerbations lead to impaired lung function , worse quality of life , and shorter survival .
BACKGROUND	We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes .
OBJECTIVE	Describe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations .
METHODS	A randomized , non-blinded , multi-center trial in 320 individuals with CF aged 14 years and older .
METHODS	The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation .
METHODS	Participants will be enrolled in the study for 12 months .
METHODS	The primary endpoint is change in FEV1 ( L ) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV1 measurements .
METHODS	Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation , number of acute pulmonary exacerbations , number of hospitalization days for acute pulmonary exacerbation , time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation , change in health related quality of life , change in treatment burden , change in CF respiratory symptoms , and adherence to the study protocol .
CONCLUSIONS	This study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations .
CONCLUSIONS	We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline , reduce respiratory symptoms and improve the quality of life for individuals with CF.

###20735782
BACKGROUND	Crohn 's disease is an inflammatory illness in which the immune response against gut microorganisms is believed to drive an abnormal immune response .
BACKGROUND	Consequently , modification of mucosal bacterial communities , and the immune effects they elicit , might be used to modify the disease state .
OBJECTIVE	To investigate the effects of synbiotic consumption on disease processes in patients with Crohn 's disease .
METHODS	A randomized , double-blind placebo-controlled trial was conducted involving 35 patients with active Crohn 's disease , using a synbiotic comprising Bifidobacterium longum and Synergy 1 .
METHODS	Clinical status was scored and rectal biopsies were collected at the start , and at 3 - and 6-month intervals .
METHODS	Transcription levels of immune markers and mucosal bacterial 16S rRNA gene copy numbers were quantified using real-time PCR .
RESULTS	Significant improvements in clinical outcomes occurred with synbiotic consumption , with reductions in both Crohn 's disease activity indices ( P = 0.020 ) and histological scores ( P = 0.018 ) .
RESULTS	The synbiotic had little effect on mucosal IL-18 , INF-gamma and IL-1beta ; however , significant reductions occurred in TNF-alpha expression in synbiotic patients at 3 months ( P = 0.041 ) , although not at 6 months .
RESULTS	Mucosal bifidobacteria proliferated in synbiotic patients .
CONCLUSIONS	Synbiotic consumption was effective in improving clinical symptoms in patients with active Crohn 's disease .

###18705707
OBJECTIVE	To describe the self-reported fluid intake and its effects on body weight , signs and symptoms of heart failure , quality of life , physical capacity and thirst , in patients with stabilised chronic heart failure .
BACKGROUND	Patients with chronic heart failure are often recommended a fluid restriction of 1.5 l/day but there is no evidence in the literature for this recommendation and little is known about the fluid intake consequences .
METHODS	Crossover study .
METHODS	Chronic heart failure patients , clinically stabilised after an unstable state , were randomised to a 32-week cross-over study assessing the clinical importance of fluid prescription .
METHODS	In a secondary analysis of 63 patients , efficacy variables were analysed in relation to the self-reported median fluid intake of 19 ml/kg body weight/day .
RESULTS	The mean fluid intake was 16 ml/kg/day in the below-median group and 24 ml/kg/day in the above-median group .
RESULTS	No between-group differences were found in change in body weight , signs and symptoms , diuretic use , quality of life or physical capacity .
RESULTS	However , the above-median group significantly decreased sense of thirst and difficulties to adhere to the fluid prescription compared with the below-median group .
CONCLUSIONS	In clinically stabilised chronic heart failure patients on optimal pharmacological treatment , a larger fluid intake was associated with decreasing thirst without any measurable negative effects on signs and symptoms of heart failure , diuretic use or physical capacity .
CONCLUSIONS	Thus , a more liberal fluid intake may be advisable in chronic heart failure patients who have been stabilised after an initial unstable clinical state .
CONCLUSIONS	Nurses involved in the care for patients with heart failure known how troublesome thirst can be and how difficult it can be to follow a restricted fluid intake .
CONCLUSIONS	This study indicates that it is possible to reassess and recommend a less strict fluid intake in stabilised patients with chronic heart failure .

###16818967
BACKGROUND	Currently , the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction .
BACKGROUND	Although this technique results in high healing rates , the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks .
BACKGROUND	The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft .
METHODS	Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft ( cancellous bone chips ) for staged reconstruction of the tibial defect .
METHODS	Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge .
METHODS	The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness .
METHODS	The Short Musculoskeletal Function Assessment ( SMFA ) was administered before and after treatment .
METHODS	Radiographs were used to document union , the presence of extracortical bridging callus , and incorporation of the bone-graft material .
RESULTS	Fifteen patients were enrolled in each group .
RESULTS	The mean length of the defect was 4 cm ( range , 1 to 7 cm ) .
RESULTS	Ten patients in the autograft group and thirteen patients in the rhBMP-2 / allograft group had healing without further intervention .
RESULTS	The mean estimated blood loss was significantly less in the rhBMP-2 / allograft group .
RESULTS	Improvement in the SMFA scores was comparable between the groups .
RESULTS	No patient in the rhBMP-2 / allograft group had development of antibodies to BMP-2 ; one patient had development of transient antibodies to bovine type-I collagen .
CONCLUSIONS	The present study suggests that rhBMP-2 / allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss .
METHODS	Therapeutic Level II .
METHODS	See Instructions to Authors for a complete description of levels of evidence .

###21498063
BACKGROUND	Indacaterol is a novel , inhaled , once-daily ultra long-acting ( 2 ) - agonist ( ultra-LABA ) for the treatment of COPD .
BACKGROUND	This study investigated the effect of indacaterol on exercise endurance , and on lung hyperinflation during exercise and at rest in patients with moderate-to-severe COPD .
METHODS	In this double-blind , placebo-controlled , two-period crossover study ( 3-week treatment , 3-week washout between treatments ) , patients were randomized to receive indacaterol 300 g once-daily or matching placebo .
METHODS	The primary efficacy variable was exercise endurance time after 3 weeks of treatment , measured through constant-load cycle ergometry testing performed at 75 % of the peak work rate in a screening incremental exercise test .
RESULTS	Of 90 patients randomized ( mean age : 62.8 years ; post-bronchodilator FEV ( 1 ) : 61.2 % predicted and FEV ( 1 ) / FVC : 51.6 % ) , 74 completed the study .
RESULTS	Pre-treatment exercise tolerance averaged 459 s. Improvement in exercise endurance time was higher with indacaterol 300 g than with placebo both after the first dose ( treatment difference : 101 s ; p < 0.001 ) and after 3 weeks ( treatment difference : 111 s ; p = 0.011 ) .
RESULTS	In addition , indacaterol increased end-exercise inspiratory capacity ( IC ) versus placebo after 3 weeks ( 0.28 L , p = 0.002 ) .
RESULTS	Significant improvements were also observed in resting IC ( 0.17 L , p = 0.001 ) , FEV ( 1 ) ( 0.25 L , p < 0.001 ) and FVC ( 0.26 L , p < 0.001 ) with indacaterol compared with placebo at 75 min post-dose after 3 weeks .
CONCLUSIONS	In conclusion , indacaterol treatment improved the ability of patients with COPD to exercise .
CONCLUSIONS	In addition , the improvements observed in resting and end-exercise IC indicate reductions in lung hyperinflation after 3 weeks treatment ( ClinicalTrials.gov registration number : NCT00620022 ) .

###12828699
BACKGROUND	An ingrown nail is a common disorder that occurs most frequently in the great toe and causes much discomfort in patients .
BACKGROUND	Although many therapeutic methods have been described , most of them can lead to severe damage to the nail or to frequent relapses .
BACKGROUND	The nail-splinting technique is known to be a noninvasive therapeutic method for treating an ingrown nail .
OBJECTIVE	Our purpose was to access the recurrence rate of the nail-splinting technique and to determine the proper removal time of the splint from the ingrown nail .
METHODS	Fifty-seven patients with ingrown nail were treated with the nail-splinting technique .
METHODS	Subjects were randomized into two groups .
METHODS	For group 1 ( 28 patients ) , the splint was removed splint 3 days after treatment , whereas for group 2 ( 29 patients ) , the splint was removed splint 2 weeks after treatment .
METHODS	All patients underwent a follow-up examination at 1 , 2 , and 4 weeks after treatment and were evaluated for tissue status and level of pain .
METHODS	After 1 year , we evaluated the rate of recurrence by means of a telephone interview with each patient .
RESULTS	A low recurrence rate ( 8.7 % ) for the nail-splinting technique was observed in both groups ( 7.1 % in group 1 vs. 10.3 % in group 2 ) .
RESULTS	The tissue status and level of pain were found to improve with time , with no statistical significance between the two groups ( P > 0.05 ) .
CONCLUSIONS	This study indicates that the nail-splinting technique constitutes a very simple and effective , noninvasive therapeutic method for treating ingrown nail .
CONCLUSIONS	We suggest that the 3-day nail-splinting technique is the most useful when the nail is intact or has only a slight defect .

###15999135
OBJECTIVE	To compare the efficacy of the high specificity Frequency Doubling Technology ( FDT ) Perimeter Screening Program ( C-20-1 ) to standard threshold automated perimetry in the diagnosis of open-angle glaucoma .
METHODS	A total of 100 consecutively presenting patients attending a glaucoma clinic who volunteered for the study ( approximately 30 % of whom were attending for an initial visit ) were examined with the FDT C-20-1 Screening Program and with the Humphrey Field Analyzer ( HFA ) SITA Fast algorithm and Program 24-2 .
RESULTS	Of the patients , 17 were excluded due to unreliable visual field results or non-glaucomatous ocular abnormalities .
RESULTS	In all , 10 patients were diagnosed as normal , 54 with open-angle glaucoma , eight with ocular hypertension , and 11 as glaucoma suspects .
RESULTS	Of the 54 glaucomatous patients , 45 exhibited high-tension glaucoma and nine normal tension glaucoma .
RESULTS	Perimetry with the HFA gave a sensitivity of 81.5 % for the combined category of glaucoma and glaucoma suspect and a specificity of 83.3 % for the combined category of normal and ocular hypertension .
RESULTS	Perimetry with the FDT gave a sensitivity of 74.5 % and a specificity of 85.2 % compared to that of the HFA .
CONCLUSIONS	In the detection of glaucoma , Program C-20-1 of the FDT perimeter exhibits high specificity .
CONCLUSIONS	It exhibits low sensitivity for the detection of mild loss but high sensitivity for advanced field loss relative to Program 24-2 and the SITA Fast algorithm of the HFA .

###11673338
BACKGROUND	Experimentally , activated macrophages have been documented to induce vascular proliferation .
RESULTS	In 21 patients ( age 74 + / -9 years ) with extensive coronary artery disease not eligible for coronary artery bypass surgery , the effect of granulocyte-macrophage colony-stimulating factor ( GM-CSF , Molgramostim ) on quantitatively assessed collateral flow was tested in a randomized , double-blind , placebo-controlled fashion .
RESULTS	The study protocol consisted of an invasive collateral flow index ( CFI ) measurement immediately before intracoronary injection of 40 microg of GM-CSF ( n = 10 ) or placebo ( n = 11 ) and after a 2-week period with subcutaneous GM-CSF ( 10 microg/kg ) or placebo , respectively .
RESULTS	CFI was determined by simultaneous measurement of mean aortic pressure ( P ( ao ) , mm Hg ) , distal coronary occlusive pressure ( P ( occl ) , mm Hg ; using intracoronary sensor guidewires ) , and central venous pressure ( CVP , mm Hg ) : CFI = ( P ( occl ) - CVP ) / ( P ( ao ) - CVP ) .
RESULTS	CFI , expressing collateral flow during coronary occlusion relative to normal antegrade flow during vessel patency , changed from 0.21 + / -0.14 to 0.31 + / -0.23 in the GM-CSF group ( P < 0.05 ) and from 0.30 + / -0.16 to 0.23 + / -0.11 in the placebo group ( P = NS ) .
RESULTS	The treatment-induced difference in CFI was +0.11 + / -0.12 in the GM-CSF group and -0.07 + / -0.12 in the placebo group ( P = 0.01 ) .
RESULTS	ECG signs of myocardial ischemia during coronary balloon occlusion occurred in 9 of 10 patients before and 5 of 10 patients after GM-CSF treatment ( P = 0.04 ) , whereas they were observed in 5 of 11 patients before and 8 of 11 patients after placebo ( P = NS ) .
CONCLUSIONS	This first clinical study investigating the potential of GM-CSF to improve collateral flow in patients with coronary artery disease documents its efficacy in a short-term administration protocol .

###18843179
BACKGROUND	Although memory for future intentions ( prospective memory , PM ) is compromised in older adults with cognitive impairment , the effectiveness of specific training techniques to help these older adults with PM tasks remains unclear .
OBJECTIVE	The present study examined the effectiveness of spaced retrieval ( rehearsing at increasingly spaced intervals ) as an intervention for improving PM in cognitively impaired older adults .
METHODS	Healthy older adults ( n = 40 ) and cognitively impaired older adults ( n = 30 ) were randomly assigned to either a spaced retrieval or a standard rehearsal condition .
RESULTS	Whilst both groups benefited from the spaced retrieval intervention , enhancement effects were substantial for the cognitively impaired older adults , and no main effect of group was observed in this condition .
CONCLUSIONS	These data indicate that spaced retrieval may be an effective means of helping cognitively impaired older adults maintain functional independence .

###23988781
OBJECTIVE	To determine whether or not there was a significant difference between the methods of centrifugation ( CF ) and multiple-pass hemoconcentration ( MPH ) of the residual cardiopulmonary-bypass volume in relation to biochemical measurements and patient outcomes .
METHODS	Prospective , randomized , and controlled .
METHODS	Conducted at a western Canadian tertiary care hospital .
METHODS	Consisted of 61 consecutive male and female patients from ages 40 to 80 who were scheduled for cardiac surgery with cardiopulmonary bypass .
METHODS	Either the centrifugation or multiple-pass hemoconcentration method was used to process the residual blood from the cardiopulmonary bypass circuit .
RESULTS	The 12-hour postoperative levels of serum hemoglobin were not significantly different in the centrifugation group as compared to the multiple-pass hemoconcentration group .
RESULTS	However , the serum levels of total protein and albumin were significantly higher in the multiple-pass hemoconcentration group as compared to the centrifugation group .
RESULTS	Additionally , after 12-hours postoperatively , the serum fibrinogen and platelet counts were significantly higher in the multiple-pass hemoconcentration group as compared to those of the centrifugation group .
RESULTS	The allogeneic product transfusion index and the chest-tube blood drainage indices were lower in the multiple-pass hemoconcentration group as compared to the centrifugation group .
CONCLUSIONS	Although the CF method provided a product in a shorter turnaround time , with consistent clearance of heparin , the MPH method trended towards enhanced biochemical and clinical patient outcomes over the 12-hour postoperative period .

###16687036
BACKGROUND	Laparoscopic adjustable gastric banding is a widely used operation for morbid obesity .
BACKGROUND	The most frequent complications of this operation are band migration and pouch dilatation ( slippage ) .
BACKGROUND	The use of the newly introduced MiniMizer Extra band with a unique gastric wall fixation system and a two-degree closure may decrease the postoperative complication rate .
BACKGROUND	Very early ( perioperative ) results are hereby reported .
METHODS	From February 2005 through October 2005 , 50 classical bands ( Obtech-Ethicon , AMI , Midband , Inamed ) and 10 MiniMizer Extra bands were inserted in our department .
METHODS	Bands were chosen randomly .
METHODS	Complications in the very early postoperative period were studied .
RESULTS	No statistically significant differences between surgery times were noted -- classical bands mean 36 min ( 20-60 ) , and MiniMizer Extra bands mean 34 min ( 25-55 ) .
RESULTS	No statistically different rates of perioperative complications were noted , with only 2 very minor intraoperative complications in the entire series .
CONCLUSIONS	The absence of problems in the perioperative period allows the use of the MiniMizer Extra band as an alternative to classical bands for short - and long-term comparison .

###25155070
OBJECTIVE	Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection ( STI ) / human immunodeficiency virus ( HIV ) risk behaviors ; however , few have demonstrated long-term efficacy .
OBJECTIVE	To evaluate the efficacy of a telephone counseling prevention maintenance intervention ( PMI ) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up .
METHODS	In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta , Georgia , 701 African American adolescent girls aged 14 to 20 years received a primary treatment and subsequently received a different ( supplemental ) treatment ( PMI ) to enhance effects of the primary treatment .
METHODS	Participants in the experimental condition ( n = 342 ) received an adapted evidence-based STI/HIV intervention ( HORIZONS ) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages .
METHODS	Comparison-condition participants ( n = 359 ) received HORIZONS and a time - and dose-consistent PMI focused on general health .
METHODS	The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up .
METHODS	Behavioral outcomes included the following : ( 1 ) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments ; ( 2 ) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol ; and ( 3 ) number of vaginal sex partners in the 6 months prior to assessments .
RESULTS	During the 36-month follow-up , fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections ( 94 vs 104 participants , respectively ; risk ratio = 0.50 ; 95 % CI , 0.28 to 0.88 ; P = .02 ) and gonococcal infections ( 48 vs 54 participants , respectively ; risk ratio = 0.40 ; 95 % CI , 0.15 to 1.02 ; P = .06 ) .
RESULTS	Participants completing more telephone contacts had a lower risk of chlamydial infection ( risk ratio = 0.95 ; 95 % CI , 0.90 to 1.00 ; P = .05 ) .
RESULTS	Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.11 ; P = .02 ) and 6 months ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.10 ; P = .04 ) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol ( mean difference = -0.61 ; 95 % CI , -0.98 to -0.24 ; P < .001 ) .
CONCLUSIONS	Sustaining the long-term impact of an STI/HIV intervention is achievable with brief , tailored telephone counseling .
BACKGROUND	clinicaltrials.gov Identifier : NCT00279799 .

###12775138
OBJECTIVE	To determine the effects of diphenhydramine 50 mg and fexofenadine 180 mg on cognitive performance using the Test of Variables of Attention ( TOVA ) , and to ascertain whether the TOVA was sufficiently sensitive to differentiate between the effects of these first - and second-generation H1-receptor antagonists on performance .
METHODS	The study used a double-blind , placebo-controlled , randomized , crossover design .
METHODS	Forty-two subjects completed four separate TOVA tests : at baseline and after administration of placebo , diphenhydramine 50 mg , and fexofenadine 180 mg .
METHODS	On each occasion , subjects rated subjective feelings of drowsiness on a visual analog scale ( VAS ) before taking the TOVA .
RESULTS	Compared with placebo , diphenhydramine caused an increased response time ( P = 0.0230 ) and more omission errors ( P = 0.0398 ) .
RESULTS	Diphenhydramine was also associated with increased drowsiness VAS ratings ( P = 0.0065 ) compared with placebo .
RESULTS	Diphenhydramine caused significantly more commission errors than fexofenadine ( P = 0.0354 ) .
RESULTS	Neither placebonor fexofenadine 180 mg caused significant changes in any TOVA or VAS measurements compared with baseline .
RESULTS	Fexofenadine was not statistically different from placebo for any evaluation .
CONCLUSIONS	The TOVA was sufficiently sensitive to differentiate between the central nervous system effects of fexofenadine and diphenhydramine .
CONCLUSIONS	Fexofenadine 180 mg had no significant effect on the TOVA measures of performance or on self-reported drowsiness compared with placebo .
CONCLUSIONS	In contrast , diphenhydramine 50 mg caused significant increases in omission errors and response time on the TOVA and increases in self-reported drowsiness compared with placebo [ corrected ] .

###8265329
OBJECTIVE	To examine , during the 3rd and 4th years of life , the health , development , rates of child maltreatment , and living conditions of children who had been enrolled in a randomized trial of nurse home visitation during pregnancy and first 2 years of their lives .
METHODS	Prospective follow-up of families who had been randomly assigned to nurse-visited and comparison conditions .
METHODS	Study conducted in semirural community in upstate New York .
METHODS	Families dispersed among 14 other states during 2-year period after children 's second birthdays .
METHODS	Four hundred women were recruited through a health department antepartum clinic and offices of private obstetricians and were registered before 30th week of pregnancy .
METHODS	All women had no previous live births and 85 % were either teenaged ( < 18 years at registration ) , unmarried , or from Hollingshead social classes IV or V. Analysis focused on whites , who comprised 89 % of sample .
METHODS	Nurse home visitation from pregnancy through second year of the child 's life .
RESULTS	There were no treatment differences in the rates of child abuse and neglect or children 's intellectual functioning from 25 to 48 months of age .
RESULTS	Nurse-visited children , nevertheless , lived in homes with fewer hazards for children ; they had 40 % fewer injuries and ingestions and 45 % fewer behavioral and parental coping problems noted in the physician record ; and they made 35 % fewer visits to the emergency department than did children in the comparison group .
RESULTS	Nurse-visited mothers were observed to be more involved with and to punish their children to a greater extent than were mothers in the comparison group .
RESULTS	The functional meaning of punishment differed between the nurse-visited and comparison families .
CONCLUSIONS	The program does have enduring effects on certain aspects of parental caregiving , safety of the home , and children 's use of the health care system , but it may be necessary to extend the length of the program for families at highest risk to produce lasting reductions in child abuse and neglect .

###20577923
OBJECTIVE	To evaluate the effects of perioperative total parenteral nutrition on cyclin D1 , recurrence and metastasis of colorectal cancer cells .
METHODS	A total of 120 patients with colorectal carcinoma were randomly divided into two groups , namely group A ( total parenteral nutrition , TPN ,60 cases ) and group B ( non total parenteral nutrition , NTPN , 60 cases ) .
METHODS	In group A , the patients were given with TPN ( including glucose , intralipid , amino acid , and vitamins , etc. ) for 10 days perioperation ( 7 days preoperatively and 3 days postoperatively ) .
METHODS	In group B , the patients did not receive any nutrition support perioperative nutrition support .
METHODS	The samples were obtained by colonoscopy preoperatively or during operation .
METHODS	Apoptosis was detected by terminal deoxynucleotidyl transferase-mediated nick end labeling ( TUNEL ) technique , expression of proliferating cell nuclear antigen ( PCNA ) by immunohistochemical staining , and the expression of cyclin D1 by in situ hybridization .
METHODS	The apoptotic index ( AI ) , the proliferating index ( PI ) , and the expression of cyclin D1 were calculated perioperatively and postoperatively .
RESULTS	After perioperative nutrition support , the expression rates of cyclin D1 , PI and AI in group A and group B were ( 35.23 + / -5.12 ) % and ( 37.53 + / -5.31 ) % , ( 7.21 + / -2.56 ) % and ( 8.75 + / -3.84 ) % , ( 53.45 + / -7.74 ) % and ( 56.74 + / -8.02 ) % respectively .
RESULTS	There were no significant difference of PI , AI and the expression of cyclin D1 ( all P > 0.05 ) between two groups .
RESULTS	The 3-year recurrent rates in two groups were 16.7 % and 15.0 % ( P > 0.05 ) .
CONCLUSIONS	Perioperative TPN can not promote proliferation and apoptosis of carcinoma cells , and has no significant impact on the expression of cyclin D1 , recurrence or metastasis of colorectal cancer .

###16613886
BACKGROUND	Twin pregnancies after IVF are still frequent and are considered high-risk pregnancies leading to high costs .
BACKGROUND	Transferring one embryo can reduce the twin pregnancy rate .
BACKGROUND	We compared cost-effectiveness of one fresh cycle elective single embryo transfer ( eSET ) versus one fresh cycle double embryo transfer ( DET ) in an unselected patient population .
METHODS	Patients starting their first IVF cycle were randomized between eSET and DET. Societal costs per couple were determined empirically , from hormonal stimulation up to 42 weeks after embryo transfer .
METHODS	An incremental cost-effectiveness ratio ( ICER ) was calculated , representing additional costs per successful pregnancy .
RESULTS	Successful pregnancy rates were 20.8 % for eSET and 39.6 % for DET. Societal costs per couple were significantly lower after eSET ( 7334 euro ) compared with DET ( 10,924 euro ) .
RESULTS	The ICER of DET compared with eSET was 19,096 euro , meaning that each additional successful pregnancy in the DET group will cost 19,096 euro extra .
CONCLUSIONS	One cycle eSET was less expensive , but also less effective compared to one cycle DET. It depends on the society 's willingness to pay for one extra successful pregnancy , whether one cycle DET is preferred from a cost-effectiveness point of view .

###24352414
OBJECTIVE	The aim of the study is to evaluate the long-term near-transfer effects of computerized working memory ( WM ) training on standard WM tasks in children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) .
METHODS	Sixty-seven children aged 10-12 years in Vestfold/Telemark counties ( Norway ) diagnosed with F90 .0 Hyperkinetic disorder ( ICD-10 ) were randomly assigned to training or control group .
METHODS	The training group participated in a 25-day training program at school , while the control group received treatment-as-usual .
METHODS	Participants were tested one week before intervention , immediately after and eight months later .
METHODS	Based on a component analysis , six measures of WM were grouped into composites representing Visual , Auditory and Manipulation WM.
RESULTS	The training group had significant long-term differential gains compared to the control group on all outcome measures .
RESULTS	Performance gains for the training group were significantly higher in the visual domain than in the auditory domain .
RESULTS	The differential gain in Manipulation WM persisted after controlling for an increase in simple storage capacity .
CONCLUSIONS	Systematic training resulted in a long-term positive gain in performance on similar tasks , indicating the viability of training interventions for children with ADHD .
CONCLUSIONS	The results provide evidence for both domain-general and domain-specific models .
CONCLUSIONS	Far-transfer effects were not investigated in this article .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN19133620 .

###11886903
BACKGROUND	An optimal outcome of closed treatment of a Colles fracture may depend on accurate reduction and adequate immobilization .
BACKGROUND	It has been suggested that the use of finger-trap traction results in a better reduction and a lower rate of redisplacement than manual manipulation does , but to our knowledge these concepts have never been evaluated scientifically .
BACKGROUND	We compared these two methods in a prospective , randomized controlled trial .
METHODS	Two hundred and twenty-three patients with 225 displaced Colles-type fractures were randomized to treatment with closed reduction with either finger-trap traction ( 112 patients ) or manual manipulation ( 111 patients ) .
METHODS	The fractures were assessed radiographically by measurement of the radial angle , dorsal tilt , and radial shortening before reduction , immediately after reduction , and at one and five weeks after reduction .
RESULTS	The groups were comparable with regard to age , sex , side of injury , fracture grade , and amount of displacement at presentation .
RESULTS	No significant differences were found between the alignment of the fractures in the two treatment groups at any time .
RESULTS	With dorsal tilt of < 10 degrees and radial shortening of < 5 mm considered acceptable , the two techniques both produced an 87 % rate of satisfactory reductions .
RESULTS	However , the percentages of fractures in an acceptable alignment were only 57 % and 50 % at one week after finger-trap traction and manual manipulation , respectively , and only 27 % and 32 % at five weeks .
RESULTS	The failure rates did not differ significantly between the two groups .
CONCLUSIONS	The two methods of fracture reduction did not differ with regard to the eventual position of the fracture or the rate of failure .
CONCLUSIONS	Although closed reduction was successful for the majority of fractures , most redisplaced substantially during the period of cast immobilization .

###18718654
OBJECTIVE	This study evaluated the effect of thermal - and mechanical-cycling on the shear bond strength of three low-fusing glassy matrix dental ceramics to commercial pure titanium ( cpTi ) when compared to conventional feldspathic ceramic fused to gold alloy .
METHODS	Metallic frameworks ( diameter : 5 mm , thickness : 4 mm ) ( N = 96 , n = 12 per group ) were cast in cpTi and gold alloy , airborne particle abraded with 150 microm aluminum oxide .
METHODS	Low-fusing glassy matrix ceramics and a conventional feldspathic ceramic were fired onto the alloys ( thickness : 4 mm ) .
METHODS	Four experimental groups were formed ; Gr1 ( control group ) : Vita Omega 900-Au-Pd alloy ; Gr2 : Triceram-cpTi ; Gr3 : Super Porcelain Ti-22-cpTi and G4 : Vita Titankeramik-cpTi .
METHODS	While half of the specimens from each ceramic-metal combination were randomly tested without aging ( water storage at 37 degrees C for 24 h only ) , the other half were first thermocycled ( 6000 cycles , between 5 and 55 degrees C , dwell time : 13 s ) and then mechanically loaded ( 20,000 cycles under 50 N load , immersion in distilled water at 37 degrees C ) .
METHODS	The ceramic-alloy interfaces were loaded under shear in a universal test machine ( crosshead speed : 0.5 mm/min ) until failure occurred .
METHODS	Failure types were noted and the interfaces of the representative fractured specimens from each group were examined with stereomicroscope and scanning electron microscope ( SEM ) .
METHODS	In an additional study ( N = 16 , n = 2 per group ) , energy dispersive X-ray spectroscopy ( EDS ) analysis was performed from ceramic-alloy interfaces .
METHODS	Data were analyzed using ANOVA and Tukey 's test .
RESULTS	Both ceramic-metal combinations ( p < 0.001 ) and aging conditions ( p < 0.001 ) significantly affected the mean bond strength values .
RESULTS	Thermal - and mechanical-cycling decreased the bond strength ( MPa ) results significantly for Gr3 ( 33.4 + / -4.2 ) and Gr4 ( 32.1 + / -4.8 ) when compared to the non-aged groups ( 42.9 + / -8.9 , 42.4 + / -5.2 , respectively ) .
RESULTS	Gr1 was not affected significantly from aging conditions ( 61.3 + / -8.4 for control , 60.7 + / -13.7 after aging ) ( p > 0.05 ) .
RESULTS	Stereomicroscope images showed exclusively adhesive failure types at the opaque ceramic-cpTi interfacial zone with no presence of ceramic on the substrate surface but with a visible dark titanium oxide layer in Groups 2-4 except Gr1 where remnants of bonder ceramic was visible .
RESULTS	EDS analysis from the interfacial zone for cpTi-ceramic groups showed predominantly 34.5-85 .1 % O ( 2 ) followed by 1.1-36 .7 % Al and 0-36 .3 % Si except for Super Porcelain Ti-22 where a small quantity of Ba ( 1.4-8 .3 % ) , S ( 0.7 % ) and Sn ( 35.3 % ) was found .
RESULTS	In the Au-Pd alloy-ceramic interface , 56.4-69 .9 % O ( 2 ) followed by 15.6-26 .2 % Si , 3.9-10 .9 % K , 2.8-6 % Na , 4.4-9 .6 % Al and 0-0 .04 % Mg was observed .
CONCLUSIONS	After thermal-cycling for 6000 times and mechanical-cycling for 20,000 times , Triceram-cpTi combination presented the least decrease among other ceramic-alloy combinations when compared to the mean bond strength results with Au-Pd alloy-Vita Omega 900 combination .

###8533565
BACKGROUND	To study the effectiveness of three different cervical ripening agents in terms of dilatation ability and patient discomfort in connection with legal first trimester abortion .
METHODS	Three randomized trials among unselected nulliparous women were performed 1 : hygroscopic tent versus gemeprost , 2 : misoprostol versus gemeprost and 3 : misoprostol administered orally 17 versus 10 hours before vacuum curettage was performed .
RESULTS	Dilatation ability , frequent gastrointestinal side effects , severe pain ( patients ' perception ) .
RESULTS	In Trial 1 , there was a tendency of a greater dilatation ability using the hygroscopic tent , while the experience of pain was a greater problem with gemeprost .
RESULTS	In Trials 2 and 3 , there were no significant differences in the dilatation abilities or gastrointestinal patient discomfort .
RESULTS	There was a tendency towards a higher demand for narcotic analgesics in patients treated with gemeprost compared with all other groups .
CONCLUSIONS	Gemeprost and misoprostol showed almost identical ability to dilate and caused patient-experienced discomfort to the same degree .
CONCLUSIONS	The use of misoprostol may be preferred as it has the advantage of being both less expensive and easier to administer .

###18223530
OBJECTIVE	The aim of this study was to evaluate the effect of two different concentrations ( 4 and 8 mg ) of dexamethasone to decrease the swelling and trismus after the surgical extraction of mandibular impacted third molars .
METHODS	This randomized clinical trial comprised thirty ( 30 ) adult patients of both genders with no local or systemic problems , with bilateral impacted lower third molars in similar position , where surgical extraction had been indicated .
METHODS	They were given 4 mg and 8 mg of dexamethasone 1 hour before the surgical procedure at the first or second surgery .
METHODS	The choice of which side to operate first and the amount of concentration of medication to use was made randomly and double-blindly .
METHODS	Postoperative pain was evaluated using a visual analog scale ( VAS ) and the degree of swelling was evaluated through facial reference points ' variation .
METHODS	The presence of trismus was analyzed through measurement of the interincisal distance ( IID ) .
METHODS	These assessments were obtained before the operation and 24h and 48 h after the surgery .
RESULTS	Based on statistic analysis ( pared t-student and Wilcoxon tests ) , the results showed a significant difference in the measurements of the degree of swelling and trismus of the treated sample .
RESULTS	8 mg of dexamethasone promoted a greater reduction of symptoms than 4 mg of dexamethasone
CONCLUSIONS	The administration of 8 mg of the dexamethasone was more effective than 4 mg of the dexamethasone to reduce the degree of swelling and trismus .
CONCLUSIONS	However , it had no effect on pain control .

###20035529
BACKGROUND	: Previous studies of video-assisted techniques for parathyroidectomy in patients with primary hyperparathyroidism have found similar or better results compared with bilateral neck exploration .
BACKGROUND	The aim of the present study was to compare open minimally invasive parathyroidectomy with the video-assisted technique for primary hyperparathyroidism in a multicentre randomized trial .
METHODS	: Some 143 patients were randomized to open ( n = 75 ) or video-assisted ( n = 68 ) parathyroidectomy after positive sestamibi scintigraphy .
METHODS	There were no differences in preoperative data .
METHODS	The open operation was performed through a 15-mm incision .
METHODS	The video-assisted techniques used were minimally invasive video-assisted parathyroidectomy ( MIVAP ) or video-assisted parathyroidectomy using the lateral approach ( VAPLA ) .
METHODS	Data were collected prospectively including postoperative pain scoring .
RESULTS	: The procedure was significantly quicker for the open compared to the video assisted operations : mean ( s.d. ) 60 ( 35 ) versus 84 ( 47 ) min ( P = 0.001 ) .
RESULTS	Both groups of patients had similar conversion rates and the same outcome , with comparable incision lengths , low scores for postoperative neck discomfort , high cosmetic satisfaction and low complication rates .
CONCLUSIONS	: Open minimally invasive parathyroidectomy for primary hyperparathyroidism was quicker than either video-assisted technique .
BACKGROUND	NCT00877981 ( http://www.clinicaltrials.gov )

###17300594
OBJECTIVE	The aim of this study was to assess the effect of sitagliptin , a dipeptidyl peptidase-4 inhibitor , on 24-h glucose control when added to the regimen of patients with type 2 diabetes who had inadequate glycaemic control on metformin therapy .
METHODS	In a double-blind , randomized , placebo-controlled , two-period crossover study , patients with type 2 diabetes with inadequate glycaemic control on metformin monotherapy ( i.e. on a stable dose of > or = 1500 mg/day for > or = 6 weeks prior to the screening visit and an haemoglobin A ( 1c ) ( HbA ( 1c ) ) > or = 6.5 % and < 10 % and fasting plasma glucose ( FPG ) < or = 240 mg/dl ) were recruited for participation .
METHODS	A total of 28 patients ( baseline HbA ( 1c ) range = 6.5-9 .6 % ) receiving metformin were randomized into one of two treatment sequences : the addition of placebo for 4 weeks followed by the addition of sitagliptin 50 mg twice daily ( b.i.d. ) for 4 weeks , or vice versa .
METHODS	At the end of each treatment period , patients were domiciled for frequent blood sampling over 24 h.
METHODS	The primary endpoint was 24-h weighted mean glucose ( WMG ) and secondary endpoints included change in FPG , mean of 7 daily self-blood glucose measurements ( MDG ) and fructosamine .
METHODS	beta-cell function was assessed from glucose and C-peptide concentrations were measured during the 5-h period after a standard breakfast meal by using the C-peptide minimal model .
RESULTS	Despite a carryover effect from period 1 to period 2 , the combined period 1 and period 2 results for glycaemic endpoints were statistically significant for sitagliptin relative to placebo when added to ongoing metformin therapy .
RESULTS	To account for the carryover effect , the period 1 results were also compared between the groups .
RESULTS	Following period 1 , there were significant least-squares ( LS ) mean reductions in 24-h WMG of 32.8 mg/dl , significant LS mean reduction from baseline in MDG of 28 mg/dl , FPG of 20.3 mg/dl and fructosamine of 33.7 mmol/l in patients treated with sitagliptin relative to placebo ( p < 0.05 ) .
RESULTS	When added to ongoing metformin therapy , parameters of beta-cell function were significantly improved with sitagliptin compared with placebo .
RESULTS	No weight gain or increases in gastrointestinal adverse events or hypoglycaemia events were observed with sitagliptin relative to placebo during this study .
CONCLUSIONS	In this study , the addition of sitagliptin 50 mg b.i.d. to ongoing metformin therapy improved 24-h glycaemic control and beta-cell function , and was generally well tolerated in patients with type 2 diabetes .

###9284876
OBJECTIVE	To compare rates of adherence to low-fat diets using food-record rating and fat-gram counting , to evaluate dietary adherence using the fat-gram counting method , and to assess correlations between food-record rating and fat-gram counting .
METHODS	A diet monitoring and observation study was conducted to compare the effectiveness of food-record rating and fat-gram counting to evaluate dietary adherence .
METHODS	Subjects were randomly assigned to the food-record rating group of the fat-gram counting group .
METHODS	Each participant was asked to complete four 3-day food records .
METHODS	Food records were evaluated by food-record rating for one group and by fat-gram counting for the other .
METHODS	Each record was then scored using the alternate system .
METHODS	For a subset , manually calculated fat-gram values were compared for accuracy with values from the Nutrient Data Systems database .
METHODS	Mantel-Haenszel chi 2 , regression , and K analyses were used to evaluate adherence rates and within-subject agreement between fat-gram counting and food-record rating .
METHODS	Seventy-eight participants were recruited from a lipid-lowering research trial conducted in Houston , Tex. .
RESULTS	Strong correlations were found between fat-gram values calculated manually and those calculated using the Nutrient Data Systems .
RESULTS	No significant differences in adherence rates were found between the food-record rating and fat-gram counting groups .
CONCLUSIONS	Fat-gram counting is at least as effective as food-record rating in monitoring dietary fat content .
CONCLUSIONS	Dietitians can use it as an alternative dietary fat-monitoring procedure for clinical practice and research .

###23383603
BACKGROUND	Pancreatic exocrine insufficiency ( PEI ) often occurs following pancreatic surgery .
OBJECTIVE	To demonstrate the superior efficacy of pancreatin 25000 minimicrospheres ( Creon 25000 MMS ; 9-15 capsules/day ) over placebo in treating PEI after pancreatic resection .
METHODS	A 1-week , double-blind , randomised , placebo-controlled , parallel-group , multicentre study with a 1-year , open-label extension ( OLE ) .
METHODS	Subjects 18years old with PEI after pancreatic resection , defined as baseline coefficient of fat absorption ( CFA ) < 80 % , were randomised to oral pancreatin or placebo ( 9-15 capsules/day : 3 with main meals , 2 with snacks ) .
METHODS	In the OLE , all subjects received pancreatin .
METHODS	The primary efficacy measure was least squares mean CFA change from baseline to end of double-blind treatment ( ancova ) .
RESULTS	All 58 subjects randomised ( 32 pancreatin , 26 placebo ) completed double-blind treatment and entered the OLE ; 51 completed the OLE .
RESULTS	The least squares mean CFA change in the double-blind phase was significantly greater with pancreatin vs. placebo : 21.4 % ( 95 % CI : 13.7 , 29.2 ) vs. -4.2 % ( -12.8 , 4.5 ) ; difference 25.6 % ( 13.9 , 37.3 ) , P < 0.001 .
RESULTS	The mean s.d. CFA increased from 53.620.6 % at baseline to 78.420.7 % at OLE end ( P < 0.001 ) .
RESULTS	Treatment-emergent adverse events occurred in 37.5 % subjects on pancreatin and 26.9 % on placebo during double-blind treatment , with flatulence being the most common ( pancreatin 12.5 % , placebo 7.7 % ) .
RESULTS	Only two subjects discontinued due to treatment-emergent adverse events , both during the OLE .
CONCLUSIONS	This study demonstrates superior efficacy of pancreatin 25000 over placebo in patients with PEI after pancreatic surgery , measured by change in CFA .
CONCLUSIONS	Pancreatin was generally well tolerated at the high dose administered ( EudraCT registration number : 2005-004854-29 ) .

###10896376
OBJECTIVE	Local wound heating improves tissue oxygen tension in postoperative patients .
METHODS	University hospital .
METHODS	Forty normothermic and well-hydrated patients recovering from elective open abdominal surgery .
METHODS	A comparison between an experimental bandage system ( Warm-Up ; Augustine Medical Inc , Eden Prairie , Minn ) and conventional gauze covered with elastic adhesive ( Medipore Dress-it ; 3M , St Paul , Minn ) .
METHODS	The experimental system is heated to 38 degrees C and does not touch the wound .
METHODS	Subcutaneous tissue oxygen tension was measured postoperatively and on the first postoperative day .
METHODS	In a subgroup , we also evaluated the effects of bandage pressure per se on tissue oxygen .
RESULTS	Initial postoperative tissue oxygen tensions were approximately 30 mm Hg greater with the experimental bandage , even before warming .
RESULTS	Subcutaneous oxygen tension during heating remained significantly greater in patients with the warmed bandage than the conventional elastic bandage ( 116 + / - 40 vs 85 + / - 34 mm Hg , respectively ) while the patients were breathing approximately 50 % oxygen .
RESULTS	The difference was smaller on the first postoperative day , but still statistically significant ( 82 + / - 30 vs 65 + / - 22 mm Hg , respectively ) .
RESULTS	In the subgroup analysis , tissue oxygen tension increased significantly by 12 + / - 4 mm Hg when the heating bandage was substituted for a conventional bandage ( P < .001 ) .
CONCLUSIONS	In normothermic and well-hydrated surgical patients , much benefit from the heating bandage system appears to result from pressure relief .
CONCLUSIONS	These data suggest that relieving wound pressure markedly improves tissue perfusion and oxygenation .

###18056488
BACKGROUND	There have been few randomized controlled trials evaluating nonoperative treatment of proximal humeral fractures .
BACKGROUND	To investigate shortening the period of dependence , we assessed the feasibility and efficacy of early mobilization of the shoulder ( within three days after the fracture ) in comparison with those of conventional three-week immobilization followed by physiotherapy .
METHODS	We randomly assigned seventy-four patients with an impacted proximal humeral fracture to receive early passive mobilization or conventional treatment .
METHODS	The primary outcome was the overall shoulder functional status ( as measured with the Constant score ) at three months .
METHODS	The secondary outcomes were the Constant score at six weeks and at six months , the change in pain ( on a visual analog scale ) , and the active and passive range of motion .
RESULTS	At three months and at six weeks , the early mobilization group had a significantly better Constant score than did the conventional-treatment group ( between-group difference , 9.9 [ 95 % confidence interval , 1.9 to 17.8 ] [ p = 0.02 ] and 10.1 [ 95 % confidence interval , 2.0 to 18.1 ] [ p = 0.02 ] , respectively ) and better active mobility in forward elevation ( between-group difference , 12.0 [ 95 % confidence interval , 1.7 to 22.4 ] [ p = 0.02 ] and 28.1 [ 95 % confidence interval , 7.1 to 49.1 ] [ p = 0.01 ] , respectively ) .
RESULTS	At three months , the early mobilization group had significantly reduced pain compared with the conventional-treatment group ( between-group difference , 15.7 [ 95 % confidence interval , 0.52 to 30.8 ] [ p = 0.04 ] ) .
RESULTS	No complications in displacement or nonhealing were noted .
CONCLUSIONS	Early mobilization for impacted nonoperatively treated proximal humeral fractures is safe and is more effective for quickly restoring the physical capability and performance of the injured arm than is conventional immobilization followed by physiotherapy .

###21843831
OBJECTIVE	Does the localised application of vibration over the hamstrings improve hamstring extensibility ?
METHODS	Randomised controlled trial with concealed allocation , intention-to-treat analysis , and assessor blinding .
METHODS	30 non-athletic females ( aged 18-22 yrs ) with limited hamstring extensibility bilaterally .
METHODS	The experimental group received 3 sessions of localised application of vibration per week for 8 weeks .
METHODS	At each session , 3 sets of vibration were applied over the left and right hamstring muscles .
METHODS	The control group continued their usual daily activities .
METHODS	Both groups were asked to perform no specific exercises during the 8-week intervention period .
METHODS	Hamstring muscle extensibility was measured bilaterally at baseline and at the end of the 8-week intervention period by measuring passive knee extension in supine with 90 deg of hip flexion .
RESULTS	At baseline , the mean lack of knee extension was 27 deg ( SD 9 ) in the experimental group and 24 deg ( SD 8 ) in the control group .
RESULTS	At 8 weeks , this had changed to 13 deg ( SD 5 ) in the experimental group and 23 deg ( SD 9 ) in the control group .
RESULTS	This was a significant treatment effect : mean between-group difference of 13 deg ( 95 % CI 11 to 16 ) .
CONCLUSIONS	An 8-week regimen of localised application of vibration over the hamstring muscles significantly reduces knee extension lack in women with reduced range on the passive knee extension test .

###12217947
OBJECTIVE	The gamma-aminobutyric acid ( GABA ( B ) ) receptor agonist , baclofen , has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans .
OBJECTIVE	The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design .
METHODS	A total of 39 alcohol-dependent patients were consecutively enrolled in the study .
METHODS	After 12-24 h of abstinence from alcohol , patients were randomly divided into two groups .
METHODS	Twenty patients were treated with baclofen and 19 with placebo .
METHODS	Drug and placebo were orally administered for 30 consecutive days .
METHODS	Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days , divided into three daily doses .
METHODS	Patients were monitored as out-patients on a weekly basis .
METHODS	At each visit alcohol intake , abstinence from alcohol , alcohol craving and changes in affective disorders were evaluated .
RESULTS	A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen , compared to the placebo , group .
RESULTS	A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group ; likewise , alcohol intake was reduced in the baclofen group .
RESULTS	A decrease in state anxiety was found in the baclofen compared to the placebo group .
RESULTS	No significant difference was found between the two groups in terms of current depressive symptoms .
RESULTS	Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects .
RESULTS	No patient was affected by craving for the drug and/or drug abuse .
CONCLUSIONS	Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics .
CONCLUSIONS	With the limits posed by the small number of subjects involved , the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations .

###16372331
BACKGROUND	To examine the prognostic value of markers of bone metabolism ( serum PINP , BAP , and CTX-I ) and serum YKL-40 in metastatic prostate carcinoma ( PC ) .
METHODS	The biomarkers were determined by ELISAs in 153 metastatic PC patients before treatment with parenteral estrogen or total androgen ablation .
METHODS	The median follow-up was 4.9 years .
METHODS	One hundred fifteen patients died .
RESULTS	The biomarkers were increased in the patients compared to controls ( P < 0.001 ) , and related to performance status and Soloway score ( except YKL-40 ) , but not to T-category and WHO tumor grade .
RESULTS	PINP was elevated in 87 % , BAP ( 55 % ) , CTX-I ( 33 % ) , and YKL-40 ( 43 % ) .
RESULTS	Univariate analysis showed an association to survival : PINP ( HR = 1.6 , P < 0.0001 ) , BAP ( HR = 1.4 , P < 0.0001 ) , CTX-I ( HR = 1.7 , P < 0.0001 ) , and YKL-40 ( HR = 1.4 , P = 0.004 ) .
RESULTS	In multivariate Cox analysis performance status , WHO grade , Soloway score , PINP , and YKL-40 were independently predictive factors .
CONCLUSIONS	High serum PINP , BAP , CTX-I , and YKL-40 are associated with poor outcome of metastatic PC patients .

###21048211
OBJECTIVE	The effects of oral aloe vera on electrocardiographic and blood pressure measurements were evaluated .
METHODS	In this double-blind , placebo-controlled , crossover study , healthy volunteers over age 18 years received either 1200 mg of oral aloe vera powder or matching placebo on day 1 of the study and the treatment not received during the first phase on day 8 .
METHODS	In each phase , electrocardiographic variables , systolic blood pressure , and diastolic blood pressure were evaluated at baseline and one , three , five , and eight hours after treatment .
METHODS	The primary endpoint was the maximum posttreatment Q-Tc interval over eight hours in both groups .
RESULTS	Sixteen participants were enrolled in the study , with a mean S.D. age of 25 5 years .
RESULTS	No significant differences in electrocardiographic or blood pressure measurements were observed .
RESULTS	The maximum Q-Tc interval was 419 17 milliseconds in the placebo group and 422 17 milliseconds in the aloe-treated group .
RESULTS	The maximum P-R intervals in the placebo - and aloe-treated groups were 166 22 and 169 25 milliseconds , respectively .
RESULTS	The maximum QRS complex duration did not significantly differ between the placebo - and aloe-treated groups ( 89.4 9 and 89.3 9 milliseconds , respectively ) .
RESULTS	The maximum systolic blood pressures in the placebo - and aloe-treated groups were 120 16 and 120 14 milliseconds , respectively .
RESULTS	The maximum diastolic blood pressures in the placebo - and aloe-treated groups were 74 10 and 75 9 milliseconds , respectively .
CONCLUSIONS	A single dose of oral aloe vera had no effect on electrocardiographic or blood pressure measurements in young healthy volunteers .

###24643203
BACKGROUND	Previous phase III studies in patients with advanced Parkinson 's disease ( PD ) not adequately controlled on levodopa demonstrated significant reduction of ` off ' time with rotigotine transdermal system up to 16 mg/24 h. However , the minimal effective dose has not been established .
OBJECTIVE	This international , randomized , double-blind , placebo-controlled study ( SP921 ; NCT00522379 ) investigated rotigotine dose response up to 8 mg/24 h.
METHODS	Patients with advanced idiopathic PD ( 2.5 h of daily ` off ' time on stable doses of levodopa ) were randomized 1:1:1:1:1 to receive rotigotine 2 , 4 , 6 , or 8 mg/24 h or placebo , titrated over 4 weeks and maintained for 12 weeks .
METHODS	The primary efficacy variable was change from baseline to end of maintenance in absolute time spent ` off ' .
RESULTS	409/514 ( 80 % ) randomized patients completed maintenance .
RESULTS	Mean ( SD ) baseline daily ` off ' times ( h/day ) were placebo : 6.4 ( 2.5 ) , rotigotine 2-8 mg/24 h : 6.4 ( 2.6 ) .
RESULTS	Rotigotine 8 mg/24 h was the minimal dose to significantly reduce ` off ' time versus placebo .
RESULTS	LS mean ( SE ) absolute change in daily ` off ' time ( h/day ) from baseline was -2.4 ( 0.28 ) with rotigotine 8 mg/24 h , and -1.5 ( 0.26 ) with placebo ; absolute change in ` off ' time in the 8 mg/24 h group compared with placebo was -0.85 h/day ( 95 % CI -1.59 , -0.11 ; p = 0.024 ) .
RESULTS	There was an apparent dose-dependent trend .
RESULTS	Adverse events ( AEs ) reported at a higher incidence in the rotigotine 8 mg/24 h group versus placebo included application site reactions , nausea , dry mouth , and dyskinesia ; there was no worsening of insomnia , somnolence , orthostatic hypotension , confusional state or hallucinations , even in patients 75 years of age .
CONCLUSIONS	The minimal statistically significant effective dose of rotigotine to reduce absolute ` off ' time was 8 mg/24 h.
CONCLUSIONS	The AE profile was similar to previous studies .

###16060962
BACKGROUND	Morbidity in COPD results from a combination of factors including hypoxia-induced pulmonary hypertension , in part due to pulmonary vascular remodelling .
BACKGROUND	Animal studies suggest a role of angiotensin II and acute studies in man concur .
BACKGROUND	Whether chronic angiotensin-II blockade is beneficial is unknown .
BACKGROUND	We studied the effects of an angiotensin-II antagonist losartan , on haemodynamic variables , exercise capacity and symptoms .
METHODS	This was a double-blind , randomized , parallel group , placebo - controlled study of 48 weeks duration .
METHODS	Forty patients with COPD and pulmonary hypertension ( Tran tricuspid pressure gradient ( TTPG ) = 30 mmHg ) were randomised to losartan 50 mg or placebo .
METHODS	Changes in TTPG were assessed at 3 , 6 and 12 months .
RESULTS	There was a trend for TTPG to increase in the placebo group ( baseline 43.4 versus 48.4 mmHg at endpoint ) and stay constant in the losartan group ( baseline 42.8 versus 43.6 mmHg ) .
RESULTS	More patients in the losartan group ( 50 % ) than in the placebo group ( 22 % ) showed a clinically meaningful reduction in TTPG at any timepoint ; these effects seemed more marked in patients with higher baseline TTPG .
RESULTS	There were no clear improvements in exercise capacity or symptoms .
CONCLUSIONS	In this 12-month pilot study , losartan 50 mg had no statistically significant beneficial effect on TTPG , exercise capacity or symptoms in pulmonary hypertension secondary to obstructive disease .
CONCLUSIONS	A sub-group of patients with higher TTPG may benefit .

###19552867
OBJECTIVE	To assess the efficacy of duloxetine 60-120 mg once daily in the prevention of depressive recurrence in outpatients with recurrent major depressive disorder ( MDD ) .
METHODS	Eligible patients with at least 3 episodes of MDD ( DSM-IV diagnosis ) in the past 5 years received open-label duloxetine 60-120 mg/day for up to 34 weeks .
METHODS	Patients meeting response criteria were then randomly assigned to either duloxetine or placebo for up to 52 weeks of double-blind maintenance treatment .
METHODS	The primary outcome measure was time to recurrence of a major depressive episode .
METHODS	Safety and tolerability were assessed via analysis of treatment-emergent adverse events ( TEAEs ) , vital signs , weight , and laboratory measures .
METHODS	Patients were recruited from 43 study centers in 5 European countries ( France , Germany , Italy , Russia , and Sweden ) and the United States .
METHODS	The study was conducted from March 2005 to January 2008 .
RESULTS	A total of 288 patients were randomly assigned to duloxetine or placebo .
RESULTS	Time to a depressive recurrence was significantly longer in duloxetine-treated patients compared with placebo-treated patients ( p < .001 ) .
RESULTS	During the double-blind maintenance phase , 33.1 % of placebo-treated patients experienced a depressive recurrence compared with 14.4 % of duloxetine-treated patients ( p < .001 ) .
RESULTS	There were no significant differences between treatment groups in TEAEs , discontinuations due to adverse events , vital signs , or weight .
CONCLUSIONS	Treatment with duloxetine was associated with a longer time to depressive recurrence and a significantly lower recurrence rate compared with placebo .
BACKGROUND	( ClinicalTrials.gov ) Identifier : NCT00105989 .

###8915229
OBJECTIVE	To compare the usefulness of dipyridamole echocardiography , dobutamine-atropine echocardiography , and exercise stress testing in the diagnosis of coronary artery disease and to analyze the agreement among the tests .
METHODS	Performance of these three tests in random order on a consecutive cohort of patients .
METHODS	A tertiary care and university center .
METHODS	One hundred two consecutive patients with chest pain and no history of coronary artery disease .
METHODS	Dipyridamole echocardiography , dobutamine-atropine echocardiography , exercise stress testing , and coronary angiography .
RESULTS	Dobutamine-atropine test was positive in 49 ( 77 % ) of 63 patients with coronary artery disease , dipyridamole test in 49 ( 77 % ) , and exercise stress test in 44 ( 68 % ; p = NS ) .
RESULTS	Both echocardiographic tests showed an overall specificity ( dipyridamole , 97 % ; dobutamine , 95 % ) higher than exercise stress test ( 79 % ; p < 0.05 ) .
RESULTS	Sensitivity of dipyridamole testing decreased from 93 to 61 % ( p = 0.002 ) if patients were receiving antianginal treatment but sensitivity of dobutamine-atropine testing was not affected ( 77 % in patients receiving and not receiving treatment ) .
RESULTS	When results were considered as positive-negative , agreement between dipyridamole and dobutamine-atropine echocardiography was 85 % ( kappa = 0.70 ) .
RESULTS	With regards to regional analysis , concordance was good ( 93 % for segments , kappa = 0.76 ; and 95 % for coronary arteries , kappa = 0.92 ) .
RESULTS	Major complications were more frequent during dobutamine-atropine ( n = 7 ) than during dipyridamole infusion ( n = 2 ) ( p = 0.06 ) .
CONCLUSIONS	Dobutamine-atropine and dipyridamole echocardiography have a similar sensitivity and a higher specificity than that obtained by exercise ECG for the diagnosis of coronary artery disease .
CONCLUSIONS	Similar information is obtained with dipyridamole and dobutamine-atropine echocardiography .
CONCLUSIONS	It is our thought that pharmacologic stress echocardiography should be used as a first-step test to rule out coronary artery disease in patients not capable of exercising .

###9578120
OBJECTIVE	Identify differences in adenoidectomy performed by curettage versus electrocautery ablation .
METHODS	To receive adenoidectomy by curettage or electrocautery ablation 38 patients undergoing adenoidectomy or adenotonsillectomy were prospectively randomized .
METHODS	The study was completed by 24 patients .
METHODS	All tonsillectomy patients received electrocautery dissection of the tonsils .
METHODS	Preoperative and at least 1 month postoperative video-nasopharyngoscopy was performed .
METHODS	Video tapes were reviewed by the authors blinded to patient identity and procedure to evaluate choanal obstruction .
METHODS	Preoperative and postoperative lateral neck radiographs were obtained .
METHODS	Blood loss and postoperative complications were recorded .
METHODS	A single , tertiary care pediatric facility .
METHODS	Electrocautery ablation of the adenoid was performed with suction cautery .
METHODS	Curettage was performed with standard adenoid curettes .
METHODS	A grading system for adenoid size was developed using radiographs and endoscopic parameters .
METHODS	The grade of preoperative and postoperative adenoid tissue was compared between the curettage and electrocautery ablation groups .
METHODS	Operative blood loss was compared between the groups .
METHODS	The postoperative course and complications were compared .
RESULTS	The preoperative grade of choanal obstruction in both groups was the same .
RESULTS	No differences could be found in the postoperative grade between the curettage and the electrocautery ablation groups .
RESULTS	No postoperative complications were recorded in either group .
RESULTS	The estimated blood loss in the curettage group was 54.5 ml ( S.D. 50.7 ) while the electrocautery ablation group averaged 3.75 ml ( S.D. 6.4 ; p = 0.0053 ) .
CONCLUSIONS	There are no differences in the postoperative results of adenoidectomy performed by electrocautery ablation or curettage .
CONCLUSIONS	There are no complications recorded in either group .
CONCLUSIONS	Estimated blood loss was lower in the electrocautery ablation group .
CONCLUSIONS	Decreased blood loss during the procedure makes the electrocautery ablation method of adenoidectomy attractive .

###15081650
BACKGROUND	Although laparoscopic resection of colorectal carcinoma improves post-operative recovery , long-term survival and disease control are the determining factors for its application .
BACKGROUND	We aimed to test the null hypothesis that there was no difference in survival after laparoscopic and open resection for rectosigmoid cancer .
METHODS	From Sept 21 , 1993 , to Oct 21 , 2002 , 403 patients with rectosigmoid carcinoma were randomised to receive either laparoscopic assisted ( n = 203 ) or conventional open ( n = 200 ) resection of the tumour .
METHODS	Survival and disease-free interval were the main endpoints .
METHODS	Patients were last followed-up in March , 2003 .
METHODS	Perioperative data were recorded and direct cost of operation estimated .
METHODS	Data were analysed by intention to treat .
RESULTS	The demographic data of the two groups were similar .
RESULTS	After curative resection , the probabilities of survival at 5 years of the laparoscopic and open resection groups were 76.1 % ( SE 3.7 % ) and 72.9 % ( 4.0 % ) respectively .
RESULTS	The probabilities of being disease free at 5 years were 75.3 % ( 3.7 % ) and 78.3 % ( 3.7 % ) , respectively .
RESULTS	The operative time of the laparoscopic group was significantly longer , whereas postoperative recovery was significantly better than for the open resection group , but these benefits were at the expense of higher direct cost .
RESULTS	The distal margin , the number of lymph nodes found in the resected specimen , overall morbidity and operative mortality did not differ between groups .
CONCLUSIONS	Laparoscopic resection of rectosigmoid carcinoma does not jeopardise survival and disease control of patients .
CONCLUSIONS	The justification for adoption of laparoscopic technique would depend on the perceived value of its effectiveness in improving short-term post-operative outcomes .

###11978744
OBJECTIVE	To determine whether the routine examination of the newborn by a midwife compared with a junior paediatrician ( SHO ) affects maternal satisfaction with this examination .
METHODS	Randomised controlled trial : 826 mother and baby pairs in a district general hospital in south east England were randomised to a paediatric SHO or a midwife for the routine newborn examination .
METHODS	Maternal satisfaction with the examination was analysed in relation to intervention group , process , and background variables .
RESULTS	Some 81 % of mothers reported that they were satisfied or very satisfied with the newborn examination .
RESULTS	Mothers assigned to a midwife were more satisfied with the newborn examination ( crude odds ratio ( OR ) 0.54 ( 95 % confidence interval ( CI ) 0.39 to 0.75 ) , p < 0.001 ) .
RESULTS	However , after provision of health education during the examination , continuity of care provided , and history of miscarriage had been controlled for , status of examiner was no longer related to maternal satisfaction ( adjusted OR 0.82 ( 95 % CI 0.57-1 .20 ) , NS ) .
RESULTS	The discussion of healthcare issues by the examiner ( adjusted OR 0.49 ( 95 % CI 0.34 to 0.70 ) , p < 0.001 ) and continuity of care ( adjusted OR 0.43 ( 95 % CI 0.23 to 0.81 ) , p < 0.01 ) were both related to enhanced satisfaction , and history of miscarriage ( adjusted OR 1.61 ( 1.08 to 2.40 ) , p < 0.05 ) was associated with lower maternal satisfaction with the newborn examination .
RESULTS	Midwives ( 61 % ) were more likely than SHOs ( 33 % ) to discuss healthcare issues , such as feeding , sleeping , and skin care .
CONCLUSIONS	Mothers were more likely to be satisfied with the newborn examination by a midwife than an SHO because midwives were more likely to discuss healthcare issues during the examination and were able to provide continuity of care .
CONCLUSIONS	However , midwife examinations according to exclusion criteria agreed with trial midwives excluded half of all newborns , and criteria may have to be reconsidered for practice implementation .

###18271716
OBJECTIVE	Percutaneous nephrolithotomy ( PCNL ) can be done in patients who have previously had open nephrolithotomy .
OBJECTIVE	Currently , dilatation of the nephrostomy tract is achieved using an Amplatz renal dilator or telescopic metal dilators in these patients .
OBJECTIVE	The aim of this study was to compare the safety and efficacy of the `` one-shot '' procedure in patients with previous open nephrolithotomy with those of the current telescopic technique .
METHODS	Thirty-one patients with past history of open surgery for kidney stone disease underwent PCNL at our institution from February 2006 to March 2007 .
METHODS	Patients were randomly divided into two groups according to dilation technique used : group A ( telescopic procedure ) and group B ( one-shot procedure ) .
METHODS	X-ray exposure , blood loss , and complications were evaluated .
RESULTS	No significant difference in hemoglobin decrease was seen in the two groups .
RESULTS	The stone-free and complication rates were the same in the two groups .
RESULTS	Fluoroscopy time during the one-shot procedure was significantly shorter than that of the telescopic procedure ( P < 0.000 ) .
CONCLUSIONS	Our experience indicated that the one-shot procedure is feasible in patients with previous open nephrolithotomy .
CONCLUSIONS	It is as safe and effective as the telescopic procedure , with significant reduction in x-ray exposure .

###15486365
BACKGROUND	Intensive oral care can reduce the incidence of pneumonia in elderly nursing home patients , but the mechanism is unknown .
OBJECTIVE	To explore the effects of intensive oral care on impaired cough reflex sensitivity , which is a known risk factor of aspiration pneumonia .
METHODS	Cough reflex sensitivity to citric acid was measured in elderly nursing home patients , who were randomly assigned to the intervention group ( n = 30 ) and the control group ( n = 29 ) .
METHODS	The patients in the intervention group had their teeth and gingiva cleaned by caregivers after every meal for 1 month .
METHODS	The patients in the control group performed their own oral care during the same period .
METHODS	Serum substance P ( SP ) concentration , cognitive function , and activities of daily living ( ADL ) were also assessed .
RESULTS	In the intervention group , cough reflex sensitivity at 30 days showed significantly higher sensitivity than baseline ( p < 0.01 ) .
RESULTS	At 30 days , the cough reflex sensitivities in the intervention group were significantly higher than that of the control group ( p < 0.05 ) .
RESULTS	Compared with the control group , the odds ratio of improvement of cough reflex sensitivity was 5.3 ( 95 % confidence interval , 1.7 to 16.0 ; p < 0.005 ) for the intervention group .
RESULTS	One month of intensive oral care did not have a significant effect on serum SP concentration , cognitive function , and ADL .
CONCLUSIONS	Intensive oral care may reduce the incidence of pneumonia by improving cough reflex sensitivity in elderly nursing home patients .

###9872196
OBJECTIVE	To determine whether changes of partial expiratory flow-volume curve ( PEFV ) and inspiratory capacity ( IC ) detect functional responses to bronchodilator in patients who do not meet the FEV1 criteria for reversibility of airway obstruction .
METHODS	The effects of salbutamol ( 200 microg by metered-dose inhaler ) on lung function were examined in 50 patients with asthma and 28 patients with COPD .
METHODS	Measurements evaluated were FEV1 , forced expiratory flow at 30 % of control FVC from maximal expiratory flow-volume curve ( Vm30 ) , forced expiratory flow at 30 % of control FVC from PEFV ( Vp30 ) , and IC .
METHODS	On a separate occasion , a representative sample of 26 subjects inhaled placebo to determine the 95 % confidence limits ( CLs ) of each of the parameters .
RESULTS	A percent and absolute increment of FEV1 above the upper CL was recorded in 28 patients .
RESULTS	Of these , 26 had a percent and absolute increase of Vp30 , 21 of Vm30 , 9 of FVC , and 11 of IC above the 95 % CL .
RESULTS	Of the 50 patients who did not have an increase in FEV1 above the 95 % CL , 25 had a percent and absolute increase in Vp30 , 15 of Vm30 , 3 of FVC , and 13 of IC above the 95 % CL .
RESULTS	On average , the percent and absolute increase Vp30 above the 95 % CL significantly identified more responders than every other parameter .
CONCLUSIONS	Increases in maximal flow detected by PEFV and/or changes in IC may be substantially obscured by the effects of inspiration to total lung capacity required for the measurement of FEV1 in patients with chronic bronchoconstriction .
CONCLUSIONS	Decreases in functional residual capacity ( FRC ) manifested by an increase of IC occur because , in patients whose FRC is dynamically determined , bronchodilatation that increases maximal flow in the tidal breathing range allows patients to breathe at lower lung volumes .
CONCLUSIONS	Changes of FEV1 frequently fail to detect significant functional response to bronchodilators in patients with chronic airflow obstruction .

###23195913
OBJECTIVE	To explore the impact of pictorial image and teach back educational strategies on knowledge , adherence to medication and diet among patients with type 2 diabetes and low health literacy in Saqqez , Iran .
METHODS	In this randomized controlled trial , 127 patients with type 2 diabetes who had low health literacy were randomly allocated into three arms of the study ( pictorial image , teach back , and control groups ) .
METHODS	The two intervention groups received education within three weekly sessions , each lasting 20 min .
METHODS	The level of functional health literacy in adults ( TOFHLA ) , diabetes knowledge , and adherence to medication and diet were measured and compared in the three groups before and six weeks after the interventions .
METHODS	We used intention to treat analysis .
METHODS	Data were analyzed using ANOVA and Paired t test .
RESULTS	Mean scores of knowledge , adherence to medication and diet revealed significant differences between two intervention groups and control group ( P < 0/001 ) six weeks after intervention .
CONCLUSIONS	Both educational strategies increased knowledge , as well as adherence to medications and diet among patients with type 2 diabetes and low health literacy .
CONCLUSIONS	Both educational strategies seem to be effective for patients with low health literacy and are recommended to be used according to patients ' conditions .

###17697456
OBJECTIVE	To compare the efficacy of two formulations of prednisolone acetate 1 % in reducing postoperative inflammation in patients having primary phacoemulsification surgery with IOL implantation .
METHODS	This multicenter study was conducted in randomized , double-masked fashion with a parallel active control group .
METHODS	Patients undergoing phacoemulsification surgery with IOL implantation were assigned to one of two treatment groups receiving study drug in addition to standard therapy .
METHODS	Study drug was administered four times daily beginning one day before surgery , postoperatively for 14 days , then twice daily until the bottle was empty .
METHODS	Clinical efficacy was compared for differences in corneal surface keratitis , anterior chamber cells and flare , and postoperative pain .
METHODS	Results were compared on day 1 , 2 weeks , and 4 weeks postoperatively .
RESULTS	No statistical differences in clinical efficacy or safety were seen between the two formulations tested at any time point evaluated .
CONCLUSIONS	In this study of routine cataract patients , both prednisolone acetate 1 % formulations are comparably effective and safe when administered for the reduction of inflammation after phacoemulsification surgery with IOL implantation .

###17082465
BACKGROUND	Phantom limb and complex regional pain syndrome type 1 ( CRPS1 ) are characterized by changes in cortical processing and organization , perceptual disturbances , and poor response to conventional treatments .
BACKGROUND	Graded motor imagery is effective for a small subset of patients with CRPS1 .
OBJECTIVE	To investigate whether graded motor imagery would reduce pain and disability for a more general CRPS1 population and for people with phantom limb pain .
METHODS	Fifty-one patients with phantom limb pain or CRPS1 were randomly allocated to motor imagery , consisting of 2 weeks each of limb laterality recognition , imagined movements , and mirror movements , or to physical therapy and ongoing medical care .
RESULTS	There was a main statistical effect of treatment group , but not diagnostic group , on pain and function .
RESULTS	The mean ( 95 % CI ) decrease in pain between pre - and post-treatment ( 100 mm visual analogue scale ) was 23.4 mm ( 16.2 to 30.4 mm ) for the motor imagery group and 10.5 mm ( 1.9 to 19.2 mm ) for the control group .
RESULTS	Improvement in function was similar and gains were maintained at 6-month follow-up .
CONCLUSIONS	Motor imagery reduced pain and disability in these patients with complex regional pain syndrome type I or phantom limb pain , but the mechanism , or mechanisms , of the effect are not clear .

###10391548
BACKGROUND	Acute hypotension , hypoxemia , cardiac arrest , and sudden death are well recognized complications during total hip arthroplasty , and they have been attributed to embolization of fat and bone marrow .
BACKGROUND	An increase in intramedullary pressure in the femur is the most important pathogenic factor for the development of embolic events .
BACKGROUND	Intravasation of fat , bone marrow , and bone debris during the implantation of a femoral component , and the embolization of these elements through the venous system located along the linea aspera and through the metaphyseal vessels , have been demonstrated experimentally and clinically .
BACKGROUND	The purpose of the present study was to compare the effects of fixation of the femoral component without cement with those of fixation with a bone-vacuum cementing technique on the severity of embolic phenomena and cardiopulmonary impairment during total hip arthroplasty .
BACKGROUND	Fixation with a conventional cementing technique was also evaluated as a control .
METHODS	Sixty patients ( sixty hips ) were entered into a prospective , randomized clinical trial .
METHODS	The patients were assigned to one of three groups .
METHODS	Group 1 consisted of twenty patients who had the femoral component inserted without cement , Group 2 comprised twenty patients who had the component inserted with a conventional cementing technique , and Group 3 included twenty patients who had fixation with the so-called bone-vacuum cementing technique .
METHODS	In the hips in Group 3 , a suction of -800 millibars ( -80,000 pascals ) was applied to a proximal drainage cannula placed along the linea aspera and a distal drainage cannula placed in the diaphysis in order to produce a vacuum in the medullary cavity of the femur during the application of cement and the insertion of the stem .
METHODS	Transesophageal echocardiography and hemodynamic and blood-gas analysis were performed during the operation .
RESULTS	Severe embolic events ( defined as a cascade of fine echogenic particles of less than five millimeters in diameter ) were observed in seventeen ( 85 percent ) of the twenty patients during insertion of the stem with use of a conventional cementing technique but in none of the patients who had the stem inserted without cement ( p < 0.05 ) .
RESULTS	Insertion of the femoral component with the bone-vacuum cementing technique prevented embolic phenomena in all but one patient ( 5 percent ) .
RESULTS	Arterial oxygen saturation decreased significantly ( p < 0.05 ) from a mean of 99.5 to 92.9 percent after insertion of the stem with a conventional cementing technique , but only slight changes were observed in the patients who had fixation of the component without cement and in those who were managed with the bone-vacuum cementing technique .
RESULTS	Intraoperative pulmonary shunt values increased a mean of 24 percent ( p < 0.05 ) when the femoral component was inserted with a conventional cementing technique , but with the numbers available we did not detect a significant change in those values when the component was fixed without cement or when it was inserted with use of the bone-vacuum cementing technique .
CONCLUSIONS	The present study showed that severe embolic events and intraoperative pulmonary impairment are common when a femoral component is fixed with use of a conventional cementing technique .
CONCLUSIONS	The results clearly demonstrated a low risk of embolism during total hip arthroplasty when the femoral component was fixed without cement and when it was fixed with the bone-vacuum cementing technique .
CONCLUSIONS	The ability of a patient to withstand an embolic event should be considered before fixation of the femoral component with use of a conventional cementing technique is planned .

###21669016
OBJECTIVE	To investigate the therapeutic effects of antioxidants on the clinical and biochemical outcome of patients with nasal polyposis .
METHODS	Thirty-four patients with nasal polyposis were divided into two groups receiving either intranasal steroid or intranasal steroid plus per-oral vitamins A , C and E and selenium .
METHODS	Paranasal sinus computed tomography , endoscopy , and polyp tissue and serum sampling were conducted pre - and post-therapy .
METHODS	Serum levels of malondialdehyde , superoxide dismutase , nitrite and myeloperoxidase and tissue levels of malondialdehyde and superoxide dismutase were measured .
METHODS	Group results were compared using the Mann-Whitney U test and Wilcoxon signed-rank test .
RESULTS	Both groups had significantly lower tissue parameters , computed tomography scores and serum malondialdehyde levels , comparing pre - versus post-treatment results .
RESULTS	Post-treatment , the steroid plus antioxidant group had significantly lower tissue malondialdehyde levels and a greater fall in tissue and serum malondialdehyde , compared with the steroid group .
CONCLUSIONS	Serum and tissue levels of malondialdehyde ( an oxidative marker ) were significantly decreased by adding antioxidants to standard therapy .
CONCLUSIONS	This is the first report of the positive effects of adding antioxidants to steroid therapy for nasal polyposis .

###25045824
BACKGROUND	GS-4774 is a recombinant , heat-killed , yeast-based immunotherapy engineered to express hepatitis B virus ( HBV ) - specific antigens .
BACKGROUND	GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection .
BACKGROUND	The aim of this study was to assess the safety , tolerability and immunogenicity of GS-4774 in healthy subjects .
METHODS	This was a randomized , open-label , dose-ascending study .
METHODS	Subjects were allocated to one of three dose groups ( n = 20 per group ) to receive 10 , 40 or 80 yeast units ( YU ; 1YU = 10 ( 7 ) yeast ) of GS-4774 in two immunization regimens ( five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals ) .
METHODS	T-cell-mediated responses were determined by interferon ( IFN ) - enzyme-linked immunospot ( ELISpot ) assay and lymphocyte-proliferation assay ( LPA ) .
RESULTS	Adverse events were reported by 39 of 60 ( 65 % ) subjects ; all were mild or moderate and none was serious .
RESULTS	Adverse events occurred most frequently in the highest dose group , 80YU , and the number of individual events was higher after weekly immunization than monthly .
RESULTS	The most common adverse events were injection-site reactions .
RESULTS	Most ( 88 % ) subjects responded to GS-4774 by at least one of the T-cell assays .
RESULTS	Following immunization with GS-4774 , IFN -- producing T-cells specific for HBV antigens were detectable in 30 ( 51 % ) subjects .
RESULTS	The ELISpot response was observed at all doses , with the highest frequency of responders occurring at the highest dose ( 10YU : 45 % ; 40YU : 35 % ; 80YU : 74 % ) .
RESULTS	Proliferative responses to HBV recombinant antigens were observed in 90 % subjects ; responses were mainly independent of GS-4774 dose and immunization regimen .
CONCLUSIONS	GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events .
CONCLUSIONS	With both weekly and monthly regimens , GS-4774 provided HBV-specific immune responses at all doses evaluated .
CONCLUSIONS	Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection .
BACKGROUND	Clinicaltrials.gov ( NCT01779505 ) .

###16054252
BACKGROUND	Nitric oxide is an endothelium dependent dilator , which may protect against atherosclerosis .
BACKGROUND	Several studies have shown a decrease in nitric oxide activity with aging , however none have assessed aging and atherosclerosis separately .
BACKGROUND	We tested the hypothesis that aging blunts both basal and receptor-mediated endothelial nitric oxide release in humans .
METHODS	We examined whether forearm blood flow responses to intra-arterial acetylcholine , and nitroprusside , were altered with aging , with and without co-infusion of an inhibitor of nitric oxide synthase ( N ( G ) - mono-methyl-L-arginine ) in three groups of human subjects ; a group with clinical atherosclerotic vascular disease ( n = 31 , 21 M ) , otherwise healthy elderly ( n = 17 , 13 M ) , and healthy young controls ( n = 15 , 8 M ) .
RESULTS	There was no difference in basal flows between the three groups .
RESULTS	There was also no difference in the dilatation to either acetylcholine or nitroprusside responses between the AVD and the healthy elderly group ; however , aging significantly decreased acetylcholine or nitroprusside responses when compared to the young controls ( p < 0.02 ) .
RESULTS	Furthermore , the ratio between acetylcholine and nitroprusside , a marker of endothelial NO synthase activity , was significantly greater in the young volunteers ( 0.816 + / - 0.094 % vs. 0.892 + / - 0.146 % vs. 1.389 + / - 0.2 % , in atherosclerotic vascular disease , healthy elderly group , and young controls respectively ) .
CONCLUSIONS	Forearm blood flow responses to endothelium dependent and independent stimuli are blunted with aging , independent of the presence of atherosclerotic disease .
CONCLUSIONS	Moreover , the normal aging process may induce significant global vascular dysfunction ( involving the endothelium and the vascular smooth muscle ) ; to as great a degree as clinically manifest atherosclerosis .

###12717124
BACKGROUND	Vocal cord sequelae and postoperative hoarseness during general anesthesia are a significant source of morbidity for patients and a source of liability for anesthesiologists .
BACKGROUND	Several risk factors leading to laryngeal injury have been identified in the past .
BACKGROUND	However , whether the quality of tracheal intubation affects their incidence or severity is still unclear .
METHODS	Eighty patients were randomized in two groups ( n = 40 for each ) to receive a propofol-fentanyl induction regimen with or without atracurium .
METHODS	Intubation conditions were evaluated with the Copenhagen Score ; postoperative hoarseness was assessed at 24 , 48 , and 72 h by a standardized interview ; and vocal cords were examined by stroboscopy before and 24 and 72 h after surgery .
METHODS	If postoperative hoarseness or vocal cord sequelae persisted , follow-up examination was performed until complete restitution .
RESULTS	Without atracurium , postoperative hoarseness occurred more often ( 16 vs. 6 patients ; P = 0.02 ) .
RESULTS	The number of days with postoperative hoarseness was higher when atracurium was omitted ( 25 vs. 6 patients ; P < 0.001 ) .
RESULTS	Similar findings were observed for vocal cord sequelae ( incidence of vocal cord sequelae : 15 vs. 3 patients , respectively , P = 0.002 ; days with vocal cord sequelae : 50 vs. 5 patients , respectively , P < 0.001 ) .
RESULTS	Excellent intubating conditions were less frequently associated with postoperative hoarseness compared to good or poor conditions ( 11 , 29 , and 57 % of patients , respectively ; excellent vs. poor : P = 0.008 ) .
RESULTS	Similar findings were observed for vocal cord sequelae ( 11 , 22 , and 50 % of patients , respectively ; excellent vs. poor : P = 0.02 ) .
CONCLUSIONS	The quality of tracheal intubation contributes to laryngeal morbidity , and excellent conditions are less frequently associated with postoperative hoarseness and vocal cord sequelae .
CONCLUSIONS	Adding atracurium to a propofol-fentanyl induction regimen significantly improved the quality of tracheal intubation and decreased postoperative hoarseness and vocal cord sequelae .

###15969892
OBJECTIVE	To evaluate the efficacy and safety of quetiapine monotherapy for mania in bipolar disorder by an a priori defined combined analysis of data from two placebo-controlled studies .
METHODS	The intent-to-treat ( ITT ) populations from two studies of patients with DSM-IV bipolar I disorder , manic episode , randomised to 12 weeks of double-blind treatment with quetiapine ( up to 800 mg/day ) or placebo were combined .
METHODS	The primary efficacy endpoint was change in Young Mania Rating Scale ( YMRS ) score from baseline to Day 21 .
METHODS	Secondary endpoints included change from baseline in YMRS to Day 84 , YMRS response and remission rates and change from baseline to Days 21 and 84 in the Montgomery-Asberg Depression Rating Scale ( MADRS ) , Clinical Global Impressions ( CGI ) , Clinical Global Impressions-Bipolar ( CGI-BP ) and the Positive and Negative Syndrome Scale ( PANSS ) .
METHODS	These endpoints were analysed as continuous variables , using an analysis of covariance ( ANCOVA ) , with the baseline as covariate .
METHODS	In order to account for any difference in response between studies , the analyses were stratified by study as a fixed effect , and centre as a random effect .
METHODS	The Cochran-Mantel-Haenszel test was used to analyse binary variables .
METHODS	A chi square test was used to compare the frequency of adverse events between the treatment groups .
RESULTS	The combined analysis included a total of 403 patients from two quetiapine monotherapy studies in patients with bipolar I disorder .
RESULTS	A significant improvement in YMRS score was observed from Day 4 ( p = 0.021 ) onward in the quetiapine group compared with placebo .
RESULTS	The treatment advantage of quetiapine over placebo continued to increase to Day 21 ( p < 0.001 ) and Day 84 ( p < 0.001 ) .
RESULTS	Significantly more quetiapine-treated than placebo-treated patients achieved a response ( p < 0.001 ) .
RESULTS	The average quetiapine dose in responders was approximately 600 mg daily .
RESULTS	Of adverse events occurring in > or = 5 % of patients , quetiapine-treated patients had a significantly greater incidence versus placebo of somnolence ( 16.3 % vs. 4.0 % ) , dry mouth ( 15.8 % vs. 3 % ) , weight gain ( 9.1 % vs. 1.5 % ) and dizziness ( 6.7 % vs. 2.5 % ) .
CONCLUSIONS	The data from this combined analysis support the results from the individual studies and indicate that quetiapine monotherapy is effective across a broad range of mood symptoms , fast-acting and well tolerated in the treatment of mania .

###9935252
BACKGROUND	This randomized open-label study assessed the penetration into gynecologic tissues of trovafloxacin , a new broad-spectrum , fourth-generation fluoroquinolone with in vitro activity against anaerobes , gram-positive , gram-negative , and atypical pathogens .
METHODS	Women undergoing hysterectomy or hysterectomy and adnexectomy received 200 mg trovafloxacin orally before surgery as a single dose or as multiple doses .
METHODS	Samples of genital tract tissue and serum were obtained simultaneously during surgery .
RESULTS	In the single-dose group , trovafloxacin concentrations in genital tract tissues were measurable for up to 30 hours .
RESULTS	Tissue concentrations of trovafloxacin after multiple doses were comparable to those after single doses .
RESULTS	Mean tissue : serum concentration ratios after a single dose were greatest in the ovary ( 1.6 microg/g ) and comparable in uterus , myometrium , cervix , and fallopian tubes ( 0.5 to 0.7 microg/g ) .
RESULTS	Adverse events after a single dose were minor .
CONCLUSIONS	A daily dose of 200 mg trovafloxacin produces gynecologic tissue concentrations that persist for up to 30 hours at levels necessary to prevent or treat pelvic infections .
CONCLUSIONS	This dosing regimen is well tolerated .

###19016254
OBJECTIVE	To examine the relationship between use of multiple health services and health utilities , quality of life and other factors in Alzheimer 's disease ( AD ) .
METHODS	Data were obtained via caregiver proxy at baseline and 3 - 6 - and 9-months post-random assignment among 421 community-dwelling AD patients participating in the CATIE-AD trial of anti-psychotic medications .
METHODS	Service use includes both institutional and outpatient services .
METHODS	Correlates include the AD-Related Quality of Life Scale ( ADRQoL ) , Health Utilities Index ( HUI ) - III , Neuropsychiatric Inventory , Mini Mental Status Examination , and AD-Cooperative Study Activities of Daily Living Scale .
METHODS	Chi squared tests , t-tests and logistic regression ( using general estimating equations ) were used to examine the correlates of service use .
RESULTS	Three quarters ( 74.2 % ) used at least one service each month .
RESULTS	Average monthly utilization rates for specific service types were : 4.5 % , inpatient hospital ; 5.6 % , nursing home ; 3.9 % , residential care ; 44.0 % , AD-related outpatient ; 9.4 % , mental health outpatient ; and 45.5 % , medical-surgical outpatient .
RESULTS	The likelihood of using any service was higher among older patients [ Odds Ratio ( OR ) = 1.03 ] and non-Hispanic Whites ( OR = 1.61 ) .
RESULTS	Each 0.10 increment on the Health Utilities Index ( HUI ) - III was associated with a 7.0 % decrease in the odds of using one or more service ( OR = 0.93 ) .
RESULTS	The odds of using outpatient and institutional services were 6.0 % and 10.0 % lower , respectively , for each 0.10 increment on the HUI-III ( OR = 0.94 , OR = 0.90 ) .
RESULTS	The AD-Related Quality of Life Scale proved significantly related to outpatient medical-surgical services only ( OR = 1.01 ) .
CONCLUSIONS	Findings suggest that the HUI-III could be combined with other known correlates of service use to inform population planning associated with AD .

###12413331
OBJECTIVE	To evaluate the magnitude of hemolysis in blood specimens collected from the heels of newborns using an automated blood collection device that uses a spring-loaded lance with blood collected using a manual lance .
METHODS	A randomized controlled trial involving 134 newborns assigned to have blood collected using either an automated blood collection device or a manual lance .
METHODS	A single experienced individual performed all blood collections .
METHODS	Serum hemoglobin concentrations were measured in all samples to gauge the extent of hemolysis .
METHODS	A neonatology unit in a 740-bed tertiary care teaching hospital .
METHODS	Healthy newborns with gestational ages ranging from 33 weeks to 41 weeks .
METHODS	Blood samples were collected from study participants at between 7 and 126 hours postpartum .
METHODS	Group 1 consisted of 66 individuals who had blood collected using the manual lance .
METHODS	Group 2 contained 68 individuals with blood collected using a spring-loaded automatic lance .
METHODS	Plasma hemoglobin content as an indicator of the extent of hemolysis .
RESULTS	There were no significant differences between newborns in groups 1 and 2 with respect to gestational age , birth weight , or time interval between birth and time of blood collection .
RESULTS	We found a highly significant difference with respect to plasma hemoglobin concentrations in specimens collected with an automated lance ( hemoglobin , 2.35 g/L ) vs that collected using the hand-held lance ( hemoglobin , 4.85 g/L ) .
CONCLUSIONS	Use of an automated spring-loaded lance allows for the collection of blood specimens with smaller levels of plasma hemoglobin .

###16888454
OBJECTIVE	To determine whether creatine ( Cr ) supplementation improves muscle performance during exposure to acute hypobaric hypoxia .
METHODS	Seven healthy men ( 28 + / - 6 yr , mean + / - SD ) performed submaximal intermittent static knee contractions interspersed with maximal voluntary contractions ( MVCs ) every minute to exhaustion ( approximately 50 % of rested MVC force ) in normoxia and hypobaric hypoxia ( separated by 3 d ) after supplementation with Cr ( 20 g.d ( -1 ) for 7 d then 5 g.d ( -1 ) for 4-7 d ) or placebo ( Pla ) in a double-blind , randomized crossover study .
METHODS	A 5-wk period without supplementation separated treatments .
METHODS	Each test day , subjects performed two bouts ( separated by 2 min ) at their preset submaximal force , 32 + / - 4 % rested MVC ) .
RESULTS	Rested MVC force ( 860 + / - 66 N ) and MVC force at exhaustion ( 396 + / - 27 N ; 47 + / - 3 % rested MVC ) did not differ among treatments or environments ( P > 0.05 ) .
RESULTS	For bout 1 , endurance time was shorter in hypobaria ( 26 + / - 3 min ) than normoxia ( 34 + / - 2 min ) ( P < 0.01 ) , but did not differ between Cr ( 27 + / - 3 min ) and Pla ( 33 + / - 3 min ) ( P > 0.05 ) .
RESULTS	MVC force returned to similar levels ( P > 0.05 ) in bout 2 after recovery in all four sessions ( to approximately 615 N ) .
RESULTS	For bout 2 , endurance time also was shorter in hypobaria ( 7 + / - 1 min ) than normoxia ( 9 + / - 1 min ) ( P < 0.03 ) but did not differ between Cr and Pla ( P > 0.05 ) .
CONCLUSIONS	This study , which used an exercise model designed to impose the same target contraction force under all experimental conditions , found no effect of Cr on maximal force , muscle endurance , or recovery in normoxia or hypobaric hypoxia .

###18468543
BACKGROUND	Schools in many countries undertake programmes for smoking prevention , but systematic reviews have shown mixed evidence of their effectiveness .
BACKGROUND	Most peer-led approaches have been classroom-based , and rigorous assessments are scarce .
BACKGROUND	We assessed the effectiveness of a peer-led intervention that aimed to prevent smoking uptake in secondary schools .
METHODS	We undertook a cluster randomised controlled trial of 10 730 students aged 12-13 years in 59 schools in England and Wales .
METHODS	29 schools ( 5372 students ) were randomly assigned by stratified block randomisation to the control group to continue their usual smoking education and 30 ( 5358 students ) to the intervention group .
METHODS	The intervention ( ASSIST [ A Stop Smoking In Schools Trial ] programme ) consisted of training influential students to act as peer supporters during informal interactions outside the classroom to encourage their peers not to smoke .
METHODS	Follow-up was immediately after the intervention and at 1 and 2 years .
METHODS	Primary outcomes were smoking in the past week in both the school year group and in a group at high risk of regular smoking uptake , which was identified at baseline as occasional , experimental , or ex-smokers .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered , number ISRCTN55572965 .
RESULTS	The odds ratio of being a smoker in intervention compared with control schools was 0.75 ( 95 % CI 0.55-1 .01 ) immediately after the intervention ( n = 9349 students ) , 0.77 ( 0.59-0 .99 ) at 1-year follow-up ( n = 9147 ) , and 0.85 ( 0.72-1 .01 ) at 2-year follow-up ( n = 8756 ) .
RESULTS	The corresponding odds ratios for the high-risk group were 0.79 ( 0.55-1 .13 [ n = 3561 ] ) , 0.75 ( 0.56-0 .99 [ n = 3483 ] ) , and 0.85 ( 0.70-1 .02 [ n = 3294 ] ) , respectively .
RESULTS	In a three-tier multilevel model with data from all three follow-ups , the odds of being a smoker in intervention compared with control schools was 0.78 ( 0.64-0 .96 ) .
CONCLUSIONS	The results suggest that , if implemented on a population basis , the ASSIST intervention could lead to a reduction in adolescent smoking prevalence of public-health importance .

###1588378
OBJECTIVE	Mastectomy versus excisional biopsy ( lumpectomy ) plus radiation for the treatment of stage I and II breast cancer was compared in a prospective randomized study .
METHODS	From 1979 to 1987 , 247 women were randomized and 237 were treated on this study .
METHODS	All patients received a full axillary dissection and all node-positive patients received adjuvant chemotherapy with cyclophosphamide and doxorubicin .
METHODS	Radiation consisted of external-beam therapy to the whole breast with or without supraclavicular nodal irradiation followed by a boost to the tumor bed .
RESULTS	The minimum time on the study was 18 months and the median time on the study was 68 months .
RESULTS	No differences in overall survival or disease-free survival were observed .
RESULTS	Actuarial estimates at 5 years showed that 85 % of mastectomy-treated patients were alive compared with 89 % of the lumpectomy/radiation patients ( P2 = .49 ; 95 % two-sided confidence interval [ CI ] about this difference , 0 % to 9 % favoring lumpectomy plus radiation ) .
RESULTS	The probability of failure in the irradiated breast was 12 % by 5 years and 20 % by 8 years according to actuarial estimates .
RESULTS	Of 15 local breast failures , 14 were treated with and 12 were controlled by mastectomy ; the ultimate local-regional control was similar in both arms of the trial .
CONCLUSIONS	These data add further weight to the conclusion that breast conservation using lumpectomy and breast irradiation is equivalent to mastectomy in terms of survival and ultimate local control for stage I and II breast cancer patients .

###21480694
OBJECTIVE	The therapeutic alliance has been linked to symptom change in numerous investigations .
OBJECTIVE	Although the alliance is commonly conceptualized as a multidimensional construct , few studies have examined its components separately .
OBJECTIVE	The current study explored which components of the alliance are most highly associated with depressive symptom change in cognitive therapy ( CT ) .
METHODS	Data were drawn from 2 published randomized , controlled clinical trials of CT for major depressive disorder ( n = 105 , mean age = 40 years , female = 62 % , White = 82 % ) .
METHODS	We examined the relations of 2 factor-analytically derived components of the Working Alliance Inventory ( WAI ; Horvath & Greenberg , 1986 , 1989 ) with symptom change on the Beck Depression Inventory-II ( BDI-II ; Beck , Steer , & Brown , 1996 ) that occurred either prior to or subsequent to the examined sessions .
METHODS	WAI ratings were obtained at an early and a late session for each therapist-patient dyad .
RESULTS	Variation in symptom change subsequent to the early session was significantly related to the WAI factor that assesses therapist-patient agreement on the goals and tasks of therapy but not to a factor assessing the affective bond between therapist and patient .
RESULTS	In contrast , both factors , when assessed in a late session , were significantly predicted by prior symptom change .
CONCLUSIONS	These findings may reflect the importance , in CT , of therapist-patient agreement on the goals and tasks of therapy .
CONCLUSIONS	In contrast , the bond between therapist and patient may be more of a consequence than a cause of symptom change in CT. .
CONCLUSIONS	The implications of these results and directions for future research are discussed .

###18602312
OBJECTIVE	Autologous bone grafting and sinus floor elevation is a widely accepted method for reconstruction of the atrophic maxilla .
OBJECTIVE	The aim of this investigation was to examine the influence of platelet-rich plasma ( PRP ) on bone grafting in sinus floor augmentation .
METHODS	A prospective , controlled , randomized study including 34 patients undergoing sinus augmentation before implant placement was designed .
METHODS	The intervention group had additional treatment with PRP .
METHODS	Radiographic imaging was performed by computerized tomography ( CT ) and panoramic radiography 4 months after augmentation and before implant placement .
RESULTS	Bone density showed no significant increase when PRP was used in combination with autologous bone grafting compared with autologous bone alone .
CONCLUSIONS	This study showed no positive effect of PRP on bone density in CT evaluation when used in sinus floor augmentation .
CONCLUSIONS	Bone density in the CT showed no correlation to histomorphometric evaluation .

###21067805
BACKGROUND	Lowering of LDL cholesterol reduces major vascular events , but whether more intensive therapy safely produces extra benefits is uncertain .
BACKGROUND	We aimed to establish efficacy and safety of more intensive statin treatment in patients at high cardiovascular risk .
METHODS	We undertook a double-blind randomised trial in 12,064 men and women aged 18-80 years with a history of myocardial infarction .
METHODS	Participants were either currently on or had clear indication for statin therapy , and had a total cholesterol concentration of at least 35 mmol/L if already on a statin or 45 mmol/L if not .
METHODS	Randomisation to either 80 mg or 20 mg simvastatin daily was done centrally using a minimisation algorithm .
METHODS	Participants were assessed at 2 , 4 , 8 , and 12 months after randomisation and then every 6 months until final follow-up .
METHODS	The primary endpoint was major vascular events , defined as coronary death , myocardial infarction , stroke , or arterial revascularisation .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered , number ISRCTN74348595 .
RESULTS	6031 participants were allocated 80 mg simvastatin daily , and 6033 allocated 20 mg simvastatin daily .
RESULTS	During a mean follow-up of 67 ( SD 15 ) years , allocation to 80 mg simvastatin produced an average 035 ( SE 001 ) mmol/L greater reduction in LDL cholesterol compared with allocation to 20 mg .
RESULTS	Major vascular events occurred in 1477 ( 245 % ) participants allocated 80 mg simvastatin versus 1553 ( 257 % ) of those allocated 20 mg , corresponding to a 6 % proportional reduction ( risk ratio 094 , 95 % CI 088-101 ; p = 010 ) .
RESULTS	There were no apparent differences in numbers of haemorrhagic strokes ( 24 [ 04 % ] vs 25 [ 04 % ] ) or deaths attributed to vascular ( 565 [ 94 % ] vs 572 [ 95 % ] ) or non-vascular ( 399 [ 66 % ] vs 398 [ 66 % ] ) causes .
RESULTS	Compared with two ( 003 % ) cases of myopathy in patients taking 20 mg simvastatin daily , there were 53 ( 09 % ) cases in the 80 mg group .
CONCLUSIONS	The 6 % ( SE 35 % ) reduction in major vascular events with a further 035 mmol/L reduction in LDL cholesterol in our trial is consistent with previous trials .
CONCLUSIONS	Myopathy was increased with 80 mg simvastatin daily , but intensive lowering of LDL cholesterol can be achieved safely with other regimens .
BACKGROUND	Merck ; The Clinical Trial Service Unit also receives funding from the UK Medical Research Council and the British Heart Foundation .

###21045674
OBJECTIVE	We compared the efficacy and safety of sodium hyaluronate ( SH ) and carboxymethylcellulose ( CMC ) in treating mild to moderate dry eye .
METHODS	Sixty-seven patients with mild to moderate dry eye were enrolled in this prospective , randomized , blinded study .
METHODS	They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1 % SH or 0.5 % CMC for 8 weeks .
METHODS	Corneal and conjunctival staining with fluorescein , tear film breakup time , subjective symptoms , and adverse reactions were assessed at baseline , 4 weeks , and 8 weeks after treatment initiation .
RESULTS	Thirty-two patients were randomly assigned to the SH group and 33 were randomly assigned to the CMC group .
RESULTS	Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores , tear film breakup time , and dry eye symptom score at 4 and 8 weeks after treatment initiation .
RESULTS	However , there were no statistically significant differences in any of the indices between the 2 treatment groups .
RESULTS	There were no significant adverse reactions observed during follow-up .
CONCLUSIONS	The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye .
CONCLUSIONS	SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula .

###20569170
BACKGROUND	Several recent studies have indicated that total antioxidant capacity ( TAOC ) of plasma seems to be compromised in chronic periodontitis ( ChP ) .
BACKGROUND	The aim of this study is to investigate plasma TAOC in patients with ChP and to assess the effects of vitamin C as an adjunct to non-surgical periodontal treatment .
METHODS	The study population consisted of 60 subjects : 30 diagnosed with ChP and 30 matched controls .
METHODS	Furthermore , patients from the ChP group were randomly allocated into ChP1 ( 15 patients received non-surgical treatment with adjunctive dose of vitamin C ) and ChP2 ( 15 patients received non-surgical periodontal treatment alone ) .
METHODS	Plasma TAOC levels were measured by an ABTS assay at baseline and 1 month post-therapy .
RESULTS	Plasma TAOC levels were significantly lower in ChP patients than controls ( P < 0.001 ) .
RESULTS	The periodontal therapy resulted in increasing plasma TAOC and improvements in clinical measures among both ChP1 and ChP2 groups ( P < 0.001 ) .
RESULTS	However , the adjunctive dose of vitamin C did not offer additional effect ( P > 0.05 ) .
CONCLUSIONS	ChP is significantly associated with lower levels of plasma TAOC .
CONCLUSIONS	The non-surgical periodontal therapy seems to reduce the oxidative stress during the periodontal inflammation .
CONCLUSIONS	However , the use of adjunctive vitamin C still needs further investigation .

###25298158
BACKGROUND	Major depressive disorder ( MDD ) places a significant disease burden on individuals as well as on societies .
BACKGROUND	Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms .
BACKGROUND	However , it is not known whether web-based interventions , when used as adjunctive treatment tools to regular psychotherapy , have an additional effect compared to regular psychotherapy for depression .
METHODS	This study is a currently recruiting pragmatic randomized controlled trial ( RCT ) that compares regular psychotherapy plus a web-based depression program ( `` deprexis '' ) with a control condition exclusively receiving regular psychotherapy .
METHODS	Adults with a depressive disorder ( N = 800 ) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions .
METHODS	The primary outcome is depressive symptoms measured with the Beck Depression Inventory ( BDI-II ) at three months post randomization .
METHODS	Secondary outcomes include changes on various indicators such as anxiety , somatic symptoms and quality of life .
METHODS	All outcomes are again assessed at the secondary endpoint six months post randomization .
METHODS	In addition , the working alliance and feasibility/acceptability of the treatment condition will be explored .
CONCLUSIONS	This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care .
BACKGROUND	ISRCTN20165665 .

###22157370
BACKGROUND	In a recent global phase 3 trial , patients with advanced non-small cell lung cancer ( NSCLC ) , who had not progressed after four cycles of platinum-based induction chemotherapy , were randomized to maintenance therapy with pemetrexed or placebo .
BACKGROUND	The objective of this retrospective , exploratory , post hoc subgroup analysis was to compare outcomes of East Asian patients with non-East Asian patients treated with pemetrexed or placebo .
METHODS	Only patients with nonsquamous histology were analyzed .
METHODS	Patients were grouped by enrollment location ( East Asian = China , Korea , or Taiwan ; non-East Asian = all other countries ) .
METHODS	The Kaplan-Meier method was used to calculate median progression-free survival ( PFS ) and overall survival ( OS ) times .
METHODS	Hazard ratios ( HRs ) were calculated using unadjusted Cox proportional hazard models .
RESULTS	Of the 663 patients enrolled in the study , 481 patients had nonsquamous NSCLC : East Asian = 27 % and non-East Asian = 73 % .
RESULTS	In the East Asian subgroup , there were more women , never smokers , and patients with adenocarcinoma .
RESULTS	PFS was similar between the subgroups and significantly prolonged in patients treated with pemetrexed than placebo ( median PFS : East Asian , 4.4 versus 1.6 months , HR = 0.42 , p < 0.001 ; non-East Asian , 4.5 versus 2.8 months , HR = 0.45 , p < 0.001 ) .
RESULTS	OS was numerically prolonged in East Asians ( median OS : pemetrexed , 19.7 months ; placebo , 16.4 months ) compared with non-East Asians ( pemetrexed , 13.2 months ; placebo , 8.5 months ) .
RESULTS	Pemetrexed was reasonably well tolerated with few severe adverse events reported .
CONCLUSIONS	The results of this subgroup analysis support pemetrexed as maintenance therapy for East Asian patients with advanced , nonsquamous NSCLC .

###21528596
OBJECTIVE	To explore the better treatment of postmenopausal osteoporosis of liver and kidney deficiency type .
METHODS	One hundred and five cases were randomly divided into an observation group , a control group A and a control group B equally .
METHODS	In control group A , Calcichew D3 tablets were taken with oral administration ; in control group B , Calcichew D3 tablets and Xianling Gubao capsule were taken with oral administration .
METHODS	In observation group , Calcichew D3 tablets and acupoint catgut embedding were applied ; Shenshu ( BL 23 ) , Ganshu ( BL 18 ) , Jiaji ( EX-B 2 ) and Weizhong ( BL 40 ) etc. were selected at acute stage ; Shenshu ( BL 23 ) and Ganshu ( BL 18 ) etc. were selected at remission stage , once every half a month and 6 months treatment in all .
METHODS	The Visual Analogue Scale ( VAS ) , bone mineral density ( BMD ) , estradiol ( E2 ) and clinical effects were compared among groups .
RESULTS	After 3 and 6 months treatment , the scores of VAS were reduced among groups ( all P < 0.01 ) ; the reduction in observation group and control group B was superior to that in control group A ( all P < 0.001 ) , and it was more obvious in observation group than that in control group B ( both P < 0.001 ) .
RESULTS	After 6 months treatment , lumbar BMD and the serum level of Ez improved obviously in observation group and control group B ( all P < 0.01 ) .
RESULTS	The comparison among groups after treatment showed that the BMD in observation group and control group B was superior o o that in control group A ( P < 0.01 , P < 0.05 ) ; the serum level of E2 in observation group was superior to that in control group B and control group A ( both P < 0.001 ) , and it in control group B was superior to that in control group A.
RESULTS	The total effective rate was 91.4 % ( 32/35 ) in observation group , superior to that in control group A ( 57.1 % , 20/35 ) ; and the total effective rate was 82.9 % ( 29/35 ) in control group B , superior to that in control group A.
CONCLUSIONS	Calcichew D3 tablets and acupoint catgut embedding therapy can relieve the pain caused by postmenopausal osteoporosis of liver and kidney deficiency , improve the bone mineral density and serum level of estradiol ; in brief , it is the better method .

###18065586
BACKGROUND	There is still uncertainty about the best procedure to alleviate iron deficiency .
BACKGROUND	Additionally more reliable methods are needed to assess the effect of iron intervention .
OBJECTIVE	We examined the efficacy of daily iron ( 10 mg ) , daily and weekly multiple-micronutrient supplementation ( 10 and 20 mg Fe , respectively ) in improving body iron stores of Indonesian infants .
METHODS	Infants aged 6-12 mo were randomly allocated to 1 of 4 groups : daily multiple-micronutrients ( DMM ) foodlike tablets ( foodLETs ) , weekly multiple-micronutrient ( WMM ) foodLETs , daily iron ( DI ) foodLETs , or daily placebo .
METHODS	Hemoglobin , ferritin , transferrin receptors , and C-reactive protein data were obtained at baseline and 23 wk .
RESULTS	Body iron estimated from the ratio of transferrin receptors to ferritin was analyzed for 244 infants .
RESULTS	At baseline , mean iron stores ( 0.5 + / - 4.1 mg/kg ) did not differ among the groups , and 45.5 % infants had deficits in tissue iron ( body iron < 0 ) .
RESULTS	At week 23 , the group DI had the highest increment in mean body iron ( 4.0 mg/kg ) , followed by the DMM group ( 2.3 mg/kg ; P < 0.001 for both ) .
RESULTS	The iron stores in the WMM group did not change , whereas the mean body iron declined in the daily placebo group ( -2.2 mg/kg ; P < 0.001 ) .
RESULTS	Compared with the daily placebo group , the DMM group gained 4.55 mg Fe/kg , the DI group gained 6.23 mg Fe/kg ( both P < 0.001 ) , and the WMM group gained 2.54 mg Fe/kg ( P = 0.001 ) .
CONCLUSIONS	When compliance can be ensured , DI and DMM foodLETs are efficacious in improving and WMM is efficacious in maintaining iron stores among Indonesian infants .

###19040336
BACKGROUND	High-density lipoprotein ( HDL ) includes discrete subfractions .
BACKGROUND	HDL exhibits anti-atherogenic properties , which have been partly linked to the activity of HDL-associated enzymes , such as the lipoprotein associated phospholipase A ( 2 ) ( HDL-LpPLA ( 2 ) ) and paraoxonase-1 ( PON1 ) .
OBJECTIVE	We assessed in an open-label randomised study the effect of orlistat and ezetimibe , alone or in combination , on plasma HDL subclasses and HDL-associated enzyme activities in overweight and obese subjects ( body mass index > 28 kg/m ( 2 ) ) with hypercholesterolemia [ total cholesterol > 200 mg/100 ml ( 5.2 mmol/l ) ] .
METHODS	Eighty-six people were prescribed a low-fat low-calorie diet and were randomly allocated to receive orlistat 120 mg , three times daily ( O group ) , ezetimibe 10 mg/day ( E group ) or both ( OE group ) for 6 months .
METHODS	HDL subfractions were determined using a polyacrylamide gel-tube electrophoresis method .
RESULTS	Levels of HDL cholesterol ( HDL-C ) and apolipoprotein AI did not change significantly in any group .
RESULTS	In group O the cholesterol concentration of HDL-2 subclass increased significantly , while the cholesterol of HDL-3 subclass decreased significantly .
RESULTS	In groups E and OE HDL-2 subclass did not significantly change , while the cholesterol concentration of HDL-3 subclass decreased significantly .
RESULTS	We observed a non-significant decrease in the HDL-LpPLA ( 2 ) and PON1 activity in all groups .
RESULTS	However , the ratios of both enzyme activities to low-density lipoprotein cholesterol ( LDL-C ) levels ( an index of atherogenicity ) significantly increased in all groups .
CONCLUSIONS	Although HDL-C levels did not change after treatment with orlistat and ezetimibe , alone or in combination , there were alterations of the HDL-2 and HDL-3 subclasses .
CONCLUSIONS	The activity of HDL-LpPLA ( 2 ) and PON1 per mg LDL-C increased significantly in all groups .

###16987360
BACKGROUND	Paracetamol is commonly used for post-operative pain management in combination with more potent analgesics .
BACKGROUND	The best route of paracetamol administration after major surgery , when oral intake may not be optimal , is not known .
BACKGROUND	Our primary purpose was to study plasma concentrations after the 1st and 4th dose of 1 g of paracetamol given either rectally or intravenously ( i.v. ) after major surgery .
METHODS	In this prospective , randomized study , 48 patients undergoing heart surgery were randomized upon arrival to the intensive care unit ( ICU ) to receive paracetamol every 6th hour either as suppositories or intravenous injections .
METHODS	In half the patients ( n = 24 ) , blood samples for paracetamol concentration were obtained before and 20 , 40 and 80 min after the first dose .
METHODS	In the other patients ( n = 24 ) , additional samples were taken prior to , and at 20 , 40 , 80 min and 4 and 6 h after , the 4th dose .
RESULTS	Plasma paracetamol concentration peaked ( 95 + / - 36 micromol/l ) within 40 min after initial i.v. administration but did not increase within 80 min after the 1st suppository .
RESULTS	Plasma concentration before the 4th dose was 74 + / - 51 and 50 + / - 27 in the rectal and i.v. groups , respectively .
RESULTS	Paracetamol concentration peaked 20 min after the 4th dose for the i.v. patients ( 210 + / - 84 micromol/l ) and declined to 99 + / - 27 micromol/l at 80 min as compared with the rectal patients 69 + / - 44 to 77 + / - 48 micromol/l .
CONCLUSIONS	Both time course and peak plasma concentrations of paracetamol given rectally differ from the one seen after intravenous administration .
CONCLUSIONS	The clinical impact of these differences needs further investigation .

###12663707
OBJECTIVE	To evaluate the role of adjuvant interferon alfa after complete resection of locally extensive renal cell carcinoma .
METHODS	A total of 283 eligible patients with pT3-4a and/or node-positive disease were randomly assigned after radical nephrectomy and lymphadenectomy to observation or to interferon alfa-NL ( Wellferon , Burroughs-Wellcome , Research Park , NC ) given daily for 5 days every 3 weeks for up to 12 cycles .
METHODS	Patients were stratified on the basis of pathologic stage .
METHODS	Patients remained on treatment until documented recurrence , excessive toxicity , or patient/physician preference deemed removal appropriate .
RESULTS	At median follow-up of 10.4 years , median survival was 7.4 years in the observation arm and 5.1 year in the treatment arm ( log-rank P = .09 ) .
RESULTS	Median recurrence-free survival was 3.0 years in the observation arm and 2.2 years in the interferon arm ( P = .33 ) .
RESULTS	Performance status ( P = .003 ) , nodal status ( N2 v N0 , P < .0001 ) , and tumor stage ( P = .0002 ) were significant prognostic factors in multivariate analysis .
RESULTS	A proportional hazards model examining the effects of treatment arm and time to recurrence on survival after recurrence among patients who recurred found that random assignment to interferon treatment ( P = .009 ) and shorter time to recurrence ( P < .0001 ) were independent predictors of shorter survival after recurrence .
RESULTS	Although no lethal toxicities were observed , severe ( grade 4 ) toxicities including neutropenia , myalgia , fatigue , depression , and other neurologic toxicities occurred in 11.4 % of those randomly assigned to interferon treatment .
CONCLUSIONS	Adjuvant treatment with interferon did not contribute to survival or relapse-free survival in this group of patients .

###26271061
BACKGROUND	The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve .
OBJECTIVE	The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up .
METHODS	The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon - and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device .
METHODS	Patients were followed-up for 1 year , with assessment of clinical outcomes and echocardiographic evaluation of valve function .
RESULTS	At 1 year , the rates of death of any cause ( 17.4 % vs. 12.8 % ; relative risk [ RR ] : 1.35 ; 95 % confidence interval [ CI ] : 0.73 to 2.50 ; p = 0.37 ) and of cardiovascular causes ( 12.4 % vs. 9.4 % ; RR : 1.32 ; 95 % CI : 0.63 to 2.75 ; p = 0.54 ) were not statistically significantly different in the balloon - and self-expandable groups , respectively .
RESULTS	The frequencies of all strokes ( 9.1 % vs. 3.4 % ; RR : 2.66 ; 95 % CI : 0.87 to 8.12 ; p = 0.11 ) and repeat hospitalization for heart failure ( 7.4 % vs. 12.8 % ; RR : 0.58 ; 95 % CI : 0.26 to 1.27 ; p = 0.19 ) did not statistically significantly differ between the 2 groups .
RESULTS	Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group ( 3.4 % vs. 0 % ; p = 0.12 ) ; all were resolved with anticoagulant therapy , suggesting a thrombotic etiology .
RESULTS	More than mild paravalvular regurgitation was more frequent in the self-expandable group ( 1.1 % vs. 12.1 % ; p = 0.005 ) .
CONCLUSIONS	Despite the higher device success rate with the balloon-expandable valve , 1-year follow-up of patients in CHOICE ( Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : Medtronic CoreValve Versus Edwards SAPIEN XT Trial ) , with limited statistical power , revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon - and self-expandable prostheses that were not statistically significantly different .
CONCLUSIONS	( A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : The CHOICE Trial ; NCT01645202 ) .

###23211655
OBJECTIVE	The European Childhood Obesity Project is a multi-centre double-blind randomised clinical trial in five countries testing whether protein intake in early life is related to later obesity risk .
OBJECTIVE	We use electronic data capture ( EDC ) in this trial and report here on our experience with the method .
METHODS	Data capture for the first two study years was done with 10 notebooks , which were installed with the RDE ( Remote Data Entry ) programme Clindoc .
RESULTS	We here exemplary report our experiences in 1 of the 11 study centres .
RESULTS	A total of 205 of 760 visits ( 27.0 % ) were documented with interim paper-based case report forms , whereas 555 ( 73.0 % ) visits were recorded with electronic case report forms ( eCRF ) .
RESULTS	The need for after-trial plausibility checks of anthropometric data is significantly reduced in visits done by eCRF in comparison with visits done by paper-based CRFs ( 14.05 % versus 35.61 % ) .
CONCLUSIONS	EDC reduces significantly the need for after-trial data checks but the planning and implementation process before starting the trial is more time-consuming .

###24375720
BACKGROUND	Deep brain stimulation ( DBS ) of the globus pallidus internus is an effective treatment for cervical dystonia ( CD ) .
BACKGROUND	Interestingly , the onset of initial DBS effects is significantly prolonged compared with that in other diseases , such as Parkinson 's disease .
BACKGROUND	The return of symptoms after cessation of DBS could be delayed as well , but this has not been studied systematically .
METHODS	In patients who were treated for CD using DBS and had a good treatment effect , we compared interruption of DBS with sham-OFF in a randomized , double-blind crossover trial .
RESULTS	We observed that dystonic features appeared within a few minutes at almost full intensity in all patients after the cessation of DBS .
CONCLUSIONS	The almost immediate onset of dystonic features in our sample seems to exclude mechanisms with long time constants from the pathophysiology of dystonia .
CONCLUSIONS	Thus , it is likely that , in these patients , an aberrant pattern of neural activity representing an inappropriate set point value for the position of the head is responsible for dystonia .

###8542001
OBJECTIVE	To evaluate the success of efforts to educate youth not only to use prescription contraceptives to avoid pregnancy , but also to use condoms to avoid sexually transmitted diseases , including infection with the human immunodeficiency virus .
METHODS	Longitudinal study of 383 African-American youth aged 9 to 15 years enrolled in a randomized , controlled trial of an acquired immunodeficiency syndrome ( AIDS ) risk reduction intervention .
METHODS	Data about contraceptive practices were obtained at baseline and 6 , 12 , and 18 months later using a culturally and developmentally appropriate risk assessment tool administered with `` talking '' computers ( Macintosh , Apple Computer Inc , Cupertino , Calif ) .
RESULTS	Approximately three fourths of sexually active youth used some form of contraception in each 6-month round , with almost half of the youth using combinations of contraceptives .
RESULTS	Among all youth at baseline and among control youth throughout the study , more than half used condoms and more than two thirds who used oral contraceptives also used condoms .
RESULTS	Receipt of an AIDS education intervention was associated with use of more effective contraceptive practices ( eg , condoms and another prescription or nonprescription method of birth control ) .
RESULTS	After receiving the intervention , more than 80 % of the youth who used oral contraceptives also used condoms .
RESULTS	Contraceptive practices showed considerable stability .
RESULTS	Knowledge about AIDS was positively associated with use of more effective contraceptive methods .
CONCLUSIONS	Many youth are using condoms and prescription birth control simultaneously , and these use rates can be increased through AIDS education interventions .

###10639684
BACKGROUND	Lorazepam has been repeatedly shown to impair both explicit memory and perceptual priming , a form of implicit memory , in the visual domain .
BACKGROUND	However , the effects of this benzodiazepine on priming in other perceptual domains , such as auditory priming , have never been explored .
OBJECTIVE	The present study investigated whether the deleterious effects of lorazepam on perceptual priming are restricted to the visual domain , or if they could be extended to the auditory domain .
METHODS	Thirty-two healthy volunteers were randomly assigned to two parallel groups , placebo and lorazepam 0.038 mg/kg .
METHODS	The drug was administered orally , following a double-blind procedure .
METHODS	In the same subjects , perceptual priming was assessed in the auditory and visual domains using similar word-stem completion tasks , and explicit memory was explored using a free-recall task .
RESULTS	Lorazepam markedly reduced free-recall performance for visually and auditorily presented words .
RESULTS	Lorazepam equally impaired visual and auditory priming .
RESULTS	In the auditory word-stem completion task , prior presentation of a word facilitated perception of its stem in the placebo group .
RESULTS	This facilitation effect was not observed in the lorazepam group .
RESULTS	The lorazepam-induced impairment of priming was not due to sedation or explicit contamination .
CONCLUSIONS	These results indicate that the deleterious effects of lorazepam on priming are not restricted to the visual modality , but extend to the auditory modality .

###22238691
BACKGROUND	Extraction of linguistically relevant auditory features is critical for speech comprehension in complex auditory environments , in which the relationships between acoustic stimuli are often abstract and constant while the stimuli per se are varying .
BACKGROUND	These relationships are referred to as the abstract auditory rule in speech and have been investigated for their underlying neural mechanisms at an attentive stage .
BACKGROUND	However , the issue of whether or not there is a sensory intelligence that enables one to automatically encode abstract auditory rules in speech at a preattentive stage has not yet been thoroughly addressed .
RESULTS	We chose Chinese lexical tones for the current study because they help to define word meaning and hence facilitate the fabrication of an abstract auditory rule in a speech sound stream .
RESULTS	We continuously presented native Chinese speakers with Chinese vowels differing in formant , intensity , and level of pitch to construct a complex and varying auditory stream .
RESULTS	In this stream , most of the sounds shared flat lexical tones to form an embedded abstract auditory rule .
RESULTS	Occasionally the rule was randomly violated by those with a rising or falling lexical tone .
RESULTS	The results showed that the violation of the abstract auditory rule of lexical tones evoked a robust preattentive auditory response , as revealed by whole-head electrical recordings of the mismatch negativity ( MMN ) , though none of the subjects acquired explicit knowledge of the rule or became aware of the violation .
CONCLUSIONS	Our results demonstrate that there is an auditory sensory intelligence in the perception of Chinese lexical tones .
CONCLUSIONS	The existence of this intelligence suggests that the humans can automatically extract abstract auditory rules in speech at a preattentive stage to ensure speech communication in complex and noisy auditory environments without drawing on conscious resources .

###22738092
OBJECTIVE	Practical choice in parenteral antiepileptic drugs ( AEDs ) remains limited despite formulation of newer intravenous agents and requirements of special patient groups .
OBJECTIVE	This study aims to compare the tolerability , safety , and side effect profiles of levetiracetam ( LEV ) against the standard agent phenytoin ( PHT ) when given intravenously and in total regimen for seizure prophylaxis in a neurosurgical setting .
METHODS	This prospective , randomized , single-center study with appropriate blinding comprised evaluation pertaining to intravenous use 3 days following craniotomy and at discharge , and to total intravenous-plus-oral AED regimen at 90 days .
METHODS	Primary tolerability end points were discontinuation because of side effect and first side effect .
METHODS	Safety combined end point was major side effect or seizure .
METHODS	Seizure occurrence and side effect profiles were compared as secondary outcomes .
RESULTS	Of 81 patients randomized , 74 ( 36 LEV , 38 PHT ) received parenteral AEDs .
RESULTS	No significant difference attributable to intravenous use was found between LEV and PHT in discontinuation because of side effect ( LEV 1/36 , PHT 2/38 , p = 1.00 ) or number of patients with side effect ( LEV 1/36 , PHT 4/38 , p = 0.36 ) .
RESULTS	No significant difference was found between LEV and PHT total intravenous-plus-oral regimen in discontinuation because of side effect ( hazard ratio [ HR ] 0.78 , 95 % confidence interval [ CI ] 0.21-2 .92 , p = 0.72 ) or number of patients with side effect ( HR 1.51 , 95 % CI 0.77-2 .98 , p = 0.22 ) .
RESULTS	More patients assigned PHT reached the undesirable clinical end point for safety of major side effect or seizure ( HR 0.09 , 95 % CI 0.01-0 .70 , p = 0.002 ) .
RESULTS	Seizures occurred only in patients assigned PHT ( n = 6 , p = 0.01 ) .
RESULTS	Although not significant , trends were observed for major side effect in more patients assigned PHT ( p = 0.08 ) and mild side effect in more assigned LEV ( p = 0.09 ) .
CONCLUSIONS	Both LEV and PHT are well-tolerated perioperatively in parenteral preparation , and in total intravenous-plus-oral prophylactic regimen .
CONCLUSIONS	Comparative safety and differing side effect profile of intravenous LEV supports use as an alternative to intravenous PHT .

###24258020
OBJECTIVE	The purpose of the study was to evaluate whether the biomembrane made of cartilage extracellular matrix , designed to provide cartilage-like favourable environments as well as to prevent against washout of blood clot after microfracture , would enhance cartilage repair compared with the conventional microfracture technique .
METHODS	A prospective trial was designed to compare the biomembrane cover after microfracture with conventional microfracture among patients with grade III-IV symptomatic cartilage defect in the knee joint .
METHODS	Patients aged 18-60 years were assigned to either the microfracture/biomembrane ( n = 45 ) or microfracture groups ( n = 19 ) .
METHODS	Among them , 24 knees in the microfracture/biomembrane and 12 knees in the microfracture were followed up for 2 years .
METHODS	Cartilage repair was assessed with magnetic resonance imagings taken 6 months , 1 year , and 2 years postoperatively , and the clinical outcomes were also recorded .
RESULTS	Compared with conventional microfracture , microfracture/biomembrane resulted in greater degree of cartilage repair ( p = 0.043 ) .
RESULTS	In the intra-group analysis , while microfracture showed moderate to good degree of cartilage repair in nearly 50 % of the patients ( 47 % at 6 months to 50 % at 2 years ; n.s. ) , microfracture/biomembrane maintained an equivalent degree of repair up to 2 years ( 88 % at 6 months to 75 % at 2 years ; n.s. ) .
RESULTS	The clinical outcome at 2 years also showed improved knee score and satisfaction and decreased pain in each group , but the difference between the two groups was not statistically significant .
CONCLUSIONS	Compared with conventional microfracture , biomembrane cover after microfracture yielded superior outcome in terms of the degree of cartilage repair during 2 years of follow-up .
CONCLUSIONS	This implies that initial protection of blood clot and immature repair tissue at the microfractured defect is important for the promotion of enhanced cartilage repair , which may be obtained by the application of a biomembrane .
METHODS	Prospective comparative study , Level II .

###22781558
BACKGROUND	Despite the clinical improvements attributed to noninvasive ventilation ( NIV ) during asthma crises , and the well established effects of nebulization , there are few studies on the effects of these interventions together .
BACKGROUND	We hypothesized that nebulization coupled to NIV should raise radio-aerosol pulmonary deposition in asthmatics .
BACKGROUND	The aims of this study were to assess the effects of coupling - agonist nebulization and NIV during asthma exacerbations on radio-aerosol pulmonary deposition , using scintigraphy and cardiopulmonary parameters , to correlate pulmonary function with radio-aerosol deposition index , radio-aerosol penetration index , and pulmonary clearance .
METHODS	In this controlled trial , 21 adults with moderate to severe asthma attack were randomized to a control group ( n = 11 ) or experimental group ( NIV + nebulizer group , n = 10 ) .
METHODS	All subjects inhaled bronchodilators for 9 minutes , and after particles were counted with a gamma camera to analyze regions of interest and pulmonary clearance at 0 , 15 , 30 , 45 , and 60 min .
RESULTS	Breathing frequency ( P = < .001 ) and minute ventilation ( P = .01 ) were reduced , and tidal volume was increased ( P = .01 ) in the NIV + nebulizer group , compared with the control group .
RESULTS	The NIV + nebulizer group had improvement from baseline values , compared to the control group in the following parameters : FEV ( 1 ) 46.7 0.5 % of predicted vs 29.8 8.9 % of predicted , P = .02 ) , FVC ( 41.2 1.5 % of predicted vs 23.2 7.1 % of predicted , P = .02 ) , peak expiratory flow ( 67.3 38.3 % of predicted vs 26.9 12.1 % of predicted , P = .01 ) , and inspiratory capacity ( 54.9 28.8 % of predicted vs 31.2 9.1 % of predicted , P = .01 ) .
RESULTS	No differences were observed between groups regarding radio-aerosol deposition index or pulmonary clearance .
RESULTS	Negative correlations were found between FEV1 , forced expiratory flow during the middle half of the FVC maneuver ( FEF ( 25-75 % ) ) , inspiratory capacity , and radio-aerosol penetration index .
CONCLUSIONS	Coupling nebulization and NIV during asthma exacerbation did not improve radio-aerosol pulmonary deposition , but we observed clinical improvement of pulmonary function in these subjects .
CONCLUSIONS	( ClinicalTrials.gov registration NCT01012050 ) .

###10102961
OBJECTIVE	To assess the influence of metronidazole resistance on the efficacy of ranitidine bismuth citrate-based triple therapy regimens in two consecutive studies .
METHODS	In the first study , patients with a culture-proven Helicobacter pylori infection were treated with ranitidine bismuth citrate 400 mg , metronidazole 500 mg , and clarithromycin 500 mg , all twice daily for 1 week ( RMC ) .
METHODS	In the second study , amoxycillin 1000 mg was substituted for clarithromycin ( RMA ) .
METHODS	Susceptibility testing for metronidazole was performed with the E-test .
METHODS	Follow-up endoscopy was performed after > / = 4 weeks .
METHODS	Antral biopsy samples were taken for histology and urease test , and culture and corpus samples for histology and culture .
RESULTS	112 patients , 53 males , age 55 + / - 14 years ( 39 duodenal ulcer , 7 gastric ulcer and 66 gastritis ) were treated with RMC , and 89 patients , 52 males , age 58 + / - 15 years ( 23 duodenal ulcer , 7 gastric ulcer and 59 gastritis ) were treated with RMA .
RESULTS	For RMC , intention-to-treat eradication results were 98 % ( 59/60 , 95 % CI : 91-100 % ) and 95 % ( 20/21 , 95 % CI : 76-100 % ) for metronidazole susceptible and resistant strains , respectively ( P = 0.45 ) .
RESULTS	For RMA these figures were 87 % ( 53/61 , 95 % CI : 76-94 % ) for metronidazole susceptible strains and 22 % ( 2/9 , 95 % CI : 3-60 % ) for resistant strains ( P = 0.0001 ) .
CONCLUSIONS	Both regimens are effective in metronidazole susceptible strains .
CONCLUSIONS	However , in contrast to the amoxycillin-containing regimen , that containing clarithromycin is also effective in resistant strains .

###18811568
OBJECTIVE	To assess the outcome and safety of the totally tubeless percutaneous nephrolithotomy in renal anomalies .
METHODS	During a prospective clinical trial from December 2002 to November 2006 , 60 patients with renal anomalies and nephrolithiasis were included in our study .
METHODS	The anomalies consisted of the horseshoe kidney , rotational anomalies of pyelocalyceal system , and ectopic kidney .
METHODS	The patients were randomly divided in two groups : the `` totally tubeless '' procedures performed in 30 patients ( the nephrostomy tube and internal stent were not used in any patient ) , and 30 patients underwent standard percutaneous nephrolithotomy ( PCNL ; using both nephrostomy tube and ureteral stent ) .
METHODS	The incidence of complications , hospital stay , transfusion requirements , and stone-free rates were compared in the two groups .
RESULTS	In the group of patients that underwent totally tubeless PCNL for the stone extraction , the mean stone burden was 2.54 cm ( 2 ) ( standard deviation [ SD ] = 0.96 ) .
RESULTS	Patients ' stay in the hospital averaged 1.3 ( SD = 0.43 ) days .
RESULTS	The average analgesics requirement was 4.5 ( SD = 1.6 ) mg of morphine .
RESULTS	The patients returned to normal activity in 10 ( SD = 3.2 ) days .
RESULTS	The postoperative complications were blood transfusion in one patient ( 3.3 % ) and fever in one patient ( 3.3 % ) .
RESULTS	An 83.3 % stone-free rate was achieved .
RESULTS	For the standard PCNL group , the mean stone size was 2.83 ( SD = 0.76 ) cm ( 2 ) , and the mean length of hospitalization was 2.6 ( SD = 0.65 ) days .
RESULTS	The average analgesics requirement was 10.4 ( SD = 3.2 ) mg of morphine , and the time to return normal activity was 15.5 ( SD = 3.2 ) days .
RESULTS	Only 2 ( 6.7 % ) patients required a transfusion , and 1 ( 3.3 % ) patient had postoperative complications ( penumothorax ) .
RESULTS	Of the 30 patients , 86.7 % became stone free .
RESULTS	The differences between operation time , transfusion rates , complications , retreatment , and overall stone-free rate were not statistically significant in the two groups but days of hospitalization ( P < 0.001 ) , analgesics requirement ( P < 0.001 ) , and time of return tonormal activity ( P < 0.001 ) were statistically significant .
CONCLUSIONS	Totally tubeless percutaneous renal surgery is a safe and effective procedure in renal anomalies and can be performed in patients even with a moderate to large stone burden .

###23276416
OBJECTIVE	The purpose of this prospective , randomized , computed tomography-based study was to investigate whether the press-fit technique reduces tunnel volume enlargement ( TVE ) and improves the clinical outcome after anterior cruciate ligament reconstruction at a minimum follow-up of 1 year compared with conventional technique .
METHODS	Sixty-nine patients undergoing primary ACL reconstruction using hamstring autografts were randomly allocated to either the press-fit technique group ( group A ) or conventional technique group ( group B ) .
METHODS	All patients were evaluated for TVE and tunnel widening using computed tomography scanning , for functional outcome using International Knee Documentation Committee and Lysholm scores , for rotational stability using the pivot-shift test , and for anterior laxity using the KT-2000 arthrometer at a minimum of 1-year follow-up .
RESULTS	There were no significant differences in TVE between the 2 groups .
RESULTS	In group A , in which the press-fit technique was used , mean volume enlargement in the femoral tunnel was 65 % compared with 71.5 % in group B ( P = .84 ) .
RESULTS	In group A , 57 % ( 20 of 35 ) of patients developed femoral TVE compared with 67 % ( 23 of 34 ) of patients in group B ( P = .27 ) .
RESULTS	Both groups showed no significant difference for functional outcome ( mean Lysholm score P = .73 , International Knee Documentation Committee score P = .15 ) , or knee laxity ( anterior P = .78 , rotational P = .22 ) at a minimum follow-up of 1 year .
CONCLUSIONS	In a comparison of press-fit and conventional techniques , there were no significant differences in TVE and clinical outcome at short-term follow-up .
METHODS	Level II , therapeutic study , prospective randomized clinical trial .

###23749315
OBJECTIVE	To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments .
METHODS	We randomized 75 women with OAB , in three groups : GI -- 30 min TENS , twice a week ; GII -- daily slow release 10 mg oxybutynin ; and GIII -- TENS + oxybutynin ( multimodal ) ; all for 12 weeks .
METHODS	Patients were evaluated with validated questionnaires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 .
RESULTS	The groups were similar before treatment .
RESULTS	After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) .
RESULTS	At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 .
RESULTS	At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 .
CONCLUSIONS	The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and QoL .

###25442646
OBJECTIVE	To assess driving ability ( brake response time [ BRT ] ) with commonly used knee braces .
METHODS	Sixty-four healthy participants ( 32 women and 32 men ) participated in our study .
METHODS	BRT was assessed using a custom-made driving simulator .
METHODS	We assessed BRT for 5 different commonly used knee braces ( right leg ) used in 9 different settings : without a knee brace ( control group ) ; with a typical postoperative knee brace with adjustable range of motion ( ROM ) and the settings of 0 to 30 , 0 to 60 , 0 to 90 , and 20 to 90 ( extension and flexion ) ; and with an unloading knee brace for moderate to severe unicompartmental osteoarthritis , an orthosis for ligament instabilities , a knee brace for patellofemoral disorders , and an elastic knee bandage .
RESULTS	The 64 participants ( mean age , 33.5 years ) showed significantly impaired BRT with the typical postoperative brace set at an ROM of 0 to 30 ( 673 milliseconds , P < .001 ) , ROM of 0 to 60 ( 629 milliseconds , P < .001 ) , ROM of 0 to 90 ( 607 milliseconds , P = .001 ) , and ROM of 20 to 90 ( 602 milliseconds , P = .005 ) compared with the control group .
RESULTS	However , no such impaired BRT was found for any other investigated knee brace .
CONCLUSIONS	Right-sided ROM-restricting knee braces involve significant impairment of BRT in healthy participants .
CONCLUSIONS	No such prolonged BRT was found for a patellofemoral realignment brace , a ligament brace , a valgus/osteoarthritis brace , or an elastic knee bandage .
CONCLUSIONS	However , our findings should be viewed in light of the limitations of the study , which are ( 1 ) the lack of a defined decrease in BRT that could lead to an accident and ( 2 ) uncertainty of whether the statistical differences are also clinically important .
METHODS	Level II , lesser-quality randomized controlled trial .

###9778080
BACKGROUND	This study was designed to investigate the efficacy of alteplase double-bolus dosing compared with the front-loaded 90-minute infusion regimen in patients with acute myocardial infarction .
BACKGROUND	Recent pilot studies have suggested that bolus dosing may provide improved efficacy in establishing early , complete , and sustained patency of the infarct-related artery in the thrombolytic treatment of acute myocardial infarction .
RESULTS	In this multicenter , randomized , open-label trial , 461 patients with acute myocardial infarction received 100 mg alteplase as a front-loaded 90-minute infusion ( 15 mg bolus , then 50 mg over a 30-minute period , then 35 mg over a 60-minute period ) or double bolus ( two 50 mg bolus injections 30 minutes apart ) .
RESULTS	All patients also received intravenous heparin and oral aspirin during and after alteplase treatment .
RESULTS	The 90-minute angiographic patency rates were 74.5 % in the double-bolus group and 81.4 % in the infusion group ( p = 0.08 ) .
RESULTS	Patency rates were also comparable for the two groups at 60 minutes ( 76.8 % vs 77.5 % ) and 24 hours ( 95.5 % vs 93.5 % ) after initiation of treatment .
RESULTS	In-hospital mortality rates were 4.5 % in the bolus group and 1.3 % in the infusion group ( p = 0.04 ) ; 30-day mortality rates were 4.5 % and 1.7 % , respectively ( p = NS ) .
RESULTS	The two-groups were comparable in frequency of all other adverse events .
CONCLUSIONS	Double-bolus alteplase administration produced reperfusion rates comparable to front-loaded infusion , but in-hospital and 30-day mortality rates were higher in the double-bolus group .
CONCLUSIONS	These findings are in agreement with those of the COBALT megatrial , which also reported a trend to higher mortality rates with double-bolus dosing .

###25693050
BACKGROUND	Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy ( ART ) globally initiate treatment prior to delivery , with lack of access to timely CD4 results being a principal barrier .
BACKGROUND	We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART .
METHODS	We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone , Botswana .
METHODS	From July 2011-April 2012 , 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing .
METHODS	CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed .
RESULTS	Three-hundred-sixty-six ART-nave women were included , 189 registering for antenatal care under Intervention and 177 under Usual Care periods .
RESULTS	Of CD4-eligible women , 100 ( 59.2 % ) women under Intervention and 79 ( 50.6 % ) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation , adjusted odds ratio ( aOR , adjusted for time that a clinic initiated Intervention ) 0.87 ( 95 % confidence interval [ CI ] 0.47-1 .63 , P = 0.67 ) .
RESULTS	The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days ( P < 0.001 ) , was appreciated by clinic staff , and was associated with reduced operational cost .
RESULTS	However , rates of ART initiation remained low , with 56 ( 36.4 % ) women registering under Intervention versus 37 ( 24.2 % ) women under Usual Care initiating ART prior to 30 weeks gestation , aOR 1.06 ( 95 % CI 0.53-2 .13 , P = 0.87 ) .
CONCLUSIONS	The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently , and this type of SMS-based results delivery platform may be useful for a variety of tests and settings .
CONCLUSIONS	However , the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation , as obstacles other than CD4 impeded ART initiation during pregnancy .

###15957509
OBJECTIVE	The human Herpesvirus type-6 ( HHV-6 ) has been implicated in multiple sclerosis ( MS ) .
OBJECTIVE	Valacyclovir is an antiviral agent with an excellent safety profile .
OBJECTIVE	A two-year placebo-controlled , double-blind study was conducted to ( 1 ) ascertain if high-dose , prolonged treatment with valacyclovir would be safe and ( 2 ) observe if valacyclovir would delay the progression of MS clinically or by magnetic resonance imaging ( MRI ) .
METHODS	Fifty-eight patients were stratified as to severity and randomly assigned to receive valacyclovir ( 3000 mg/day ) or placebo for a period of two years .
METHODS	Patients were followed clinically over the two-year period by means of the Expanded Disability Status Scale ( EDSS ) , the Ambulation Index ( AI ) and brain MRI scans .
METHODS	Patients underwent routine lab studies every three months .
METHODS	Patients continued on the medication for two years unless they had a sustained progression or repeated exacerbations .
RESULTS	No patient discontinued the study due to side effects or toxicity .
RESULTS	In Relative Ranking of Progression , time to first attack , attack rate , and time to withdrawal there were trends ( but not statistically significant ) toward drug effect over placebo in the Severe clinical category .
RESULTS	MRI evaluation showed no significant drug effect .
CONCLUSIONS	Although not statistically significant , positive trends were detected for acyclovir by clinical measures , but not by MRI .

###11074109
BACKGROUND	The aim of this study was to test the efficacy of critically timed sleep deprivation in major mood disorders ( MMD ) occurring during pregnancy and postpartum .
METHODS	Nine women who met DSM-IV criteria for a MMD with onset during pregnancy or within 1 year postpartum underwent a trial of either early-night sleep deprivation ( ESD ) , in which they were sleep deprived in the early part of one night and slept from 03:00 -07:00 h , or late-night sleep deprivation ( LSD ) , in which they were deprived of sleep in the latter part of one night and slept from 21:00 -01:00 h. Mood was assessed before the night of sleep deprivation , after the night of sleep deprivation , and after a night of recovery sleep ( sleep 22:30 -06:30 h ) by trained clinicians , blind to treatment condition , using standardized scales .
RESULTS	More patients responded to LSD ( nine of 11 trials : 82 % ) compared with ESD ( two of six trials : 33 % ) and they responded more after a night of recovery sleep ( nine of 11 nights : 82 % ) than after a night of sleep deprivation ( six of 11 nights : 55 % ) .
RESULTS	Pregnant women were the only responders to ESD and the only nonresponders to LSD .
CONCLUSIONS	The small and heterogeneous sample size prevents us from making more definitive conclusions based on statistical analyses .
CONCLUSIONS	Although the findings are preliminary , the results suggest that with further study , critically timed sleep deprivation interventions may benefit women with pregnancy or postpartum major mood disorders and potentially provide a viable alternative treatment modality for those women who are not candidates for pharmacologic or psychotherapeutic interventions .
CONCLUSIONS	Such interventions are needed to help prevent the devastating effects of depression during pregnancy and the postpartum period on the mother , infant , her family and society .

###24768120
BACKGROUND	Deep brain stimulation ( DBS ) is an effective and approved therapy for advanced Parkinson 's disease ( PD ) , and a recent study suggests efficacy in mid-stage disease .
BACKGROUND	This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD .
METHODS	Thirty subjects with idiopathic PD ( Hoehn & Yahr Stage II off medication ) , age 50-75 , on medication 6 months but 4 years , and without motor fluctuations or dyskinesias were randomized to optimal drug therapy ( ODT ) ( n = 15 ) or DBS + ODT ( n = 15 ) .
METHODS	Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months .
RESULTS	As hypothesized , the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months .
RESULTS	Medication requirements in the DBS + ODT group were lower at all time points with a maximal difference at 18 months .
RESULTS	With a few exceptions , differences in neuropsychological functioning were not significant .
RESULTS	Two subjects in the DBS + ODT group suffered serious adverse events ; remaining adverse events were mild or transient .
CONCLUSIONS	This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD .
CONCLUSIONS	The results of this trial provide the data necessary to design a large , phase III , double-blind , multicenter trial investigating the safety and efficacy of DBS in early PD .

###16553177
BACKGROUND	Dinoprostone vaginal insert has been compared to Dinoprostone cervical gel in few studies , whose cases presented different Bishop scores and gestational ages at admission , and various treatment strategies in control arms .
BACKGROUND	The present study compares the vaginal insert to the cervical gel in patients with low Bishop score at term .
METHODS	Prospective multicenter randomized trial , with parity-based randomization .
METHODS	Admission criteria : single pregnancy with Bishop score of 0-4 , gestational age of 37-41 weeks , intact membranes , no previous cesarean section , no bleeding or abnormal cardiotocography at admission .
RESULTS	Vaginal prostaglandins were required as a second-line induction procedure in 25 % of study patients versus 47.1 % of controls ( p < 0.03 , chi2 ) .
RESULTS	Study patients experienced shorter induction-to-delivery time ( 920 + / - 428 versus 1,266 + / - 740 min , p < 0,01 ) , with a mean difference of 5 h and 46 min between the groups .
RESULTS	Even though patients that received vaginal insert showed a trend of increased incidence of abnormal cardiotocography during labor ( 12 % versus 6.3 % ) and hyperkinetic labor ( 11.8 % versus 2.1 % ) , the incidence of cesarean sections ( 21.4 % versus 21.6 % ) , cesareans for fetal distress ( 12.5 % versus 11.8 % ) , and umbilical artery pH < 7.10 ( 4.9 % versus 2.5 % ) was comparable between the two groups .
CONCLUSIONS	Dinoprostone vaginal insert is more efficient than cervical gel in promoting cervical priming and labor induction in low-Bishop-score patients at term .
CONCLUSIONS	The vaginal insert placement seems to be safe for the mother and the newborn , although larger studies are required to investigate uterine hyperstimulation incidence .

###22718671
OBJECTIVE	Obsessive-Compulsive Disorder ( OCD ) is a common neuropsychiatric condition .
OBJECTIVE	Many herbs with psychotropic effects exist which can have fewer side effects compared to more conventional medications .
OBJECTIVE	Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in the world with an effect on GABA .
OBJECTIVE	This plant is reported to be safe on humans .
OBJECTIVE	Our objective in this study was to compare the efficacy of the extract of Valeriana Officinalis L. with placebo in the treatment of OCD .
METHODS	The study was an 8-week pilot double-blind randomized trial .
METHODS	Thirty-one adult outpatients who met the DSM-IV-TR criteria for OCD based on the structured clinical interview participated in the trial .
METHODS	In this double-blind and randomized trial , patients were randomly assigned to receive either capsule of the extract ( 765 mg/day ) or placebo ( 30 mg/day ) for 8 weeks .
RESULTS	The results showed significant difference between the extract and placebo in the end of treatment ( P = 0.000 ) .
RESULTS	Somnolence was the only significant difference between the two groups in terms of observed side effects ( P = 0.02 ) .
CONCLUSIONS	The results suggest that Valeriana Officinalis L. has some antiobsessive and compulsive effects .
CONCLUSIONS	However , further studies are needed to confirm these findings .
CONCLUSIONS	Psychiatrists often find that many patients can not tolerate the side effects of psychiatry medicine Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in world with effect on GABA.The results showed significant difference between the extract and placebo in the treatment of OCD .
CONCLUSIONS	There was also no significant difference between the two groups in terms of observed side effects .

###23876536
OBJECTIVE	To investigate whether randomized diet and/or physical exercise influence serum levels of antimllerian hormone ( AMH ) in obese women with polycystic ovary syndrome ( PCOS ) .
METHODS	Randomized , 4-month trial with three interventions .
METHODS	Women 's health clinical research unit at a university hospital .
METHODS	Fifty-seven overweight/obese women with PCOS .
METHODS	Diet , physical exercise , or both , using programs individually adapted and supervised by a dietician and/or a physiotherapist .
METHODS	Serum AMH levels before and after the interventions and correlations to reproductive function , body composition , and endocrine and metabolic variables .
RESULTS	After intervention , serum levels of AMH were significantly decreased only in the diet group , and the levels were significantly lower than in the exercise group .
RESULTS	The strongest predictor of decreased AMH was a decrease in free T , whereas weight loss had no significant influence .
RESULTS	Normalized levels of AMH were associated with improvements in menstrual cyclicity and hyperandrogenism but not in metabolic variables .
CONCLUSIONS	This randomized study supports that diet reduces serum AMH in association with decreased androgen levels in obese women with PCOS .
CONCLUSIONS	Increased serum AMH may be used as a marker of ovulatory dysfunction and hyperandrogenism but not as a marker of insulin resistance .
BACKGROUND	ISRCTN48342048 .

###11861354
OBJECTIVE	To evaluate the efficacy of inhaled nitric oxide ( iNO ) on oxygenation , shunt , and pulmonary vascular resistance index ( PVRI ) in severely hypoxemic , ventilated patients .
METHODS	In a two-period double-blind crossover design , 14 critically ill , hypoxemic , ventilated patients were randomized to receive iNO 10 ppm in 100 % oxygen or no iNO in 100 % oxygen for 30 min followed by a 30-min washout period and then crossed over to the other intervention .
METHODS	Responders to iNO then received iNO , which was increased from 5 ppm to 25 ppm in 5 ppm increments .
METHODS	Severity of illness scores and cardiorespiratory variables were measured .
RESULTS	Nitric oxide decreased shunt ( P = 0.002 ) and PVRI ( P = 0.033 ) and increased oxygenation ( P = 0.011 ) although the latter two were not statistically significant after adjustment for multiple comparisons .
RESULTS	Treatment by period interactions were observed .
CONCLUSIONS	Our findings suggest that iNO improves oxygenation to a clinically significant extent in critically ill patients who are severely hypoxemic .

###12719047
OBJECTIVE	To examine the influence of epidural morphine on the end-tidal sevoflurane concentration titrated to maintain bispectral index ( BIS ) values between 40 and 50 .
METHODS	Prospective , double-blinded clinical trial .
METHODS	Anesthesia department of a university hospital .
METHODS	40 ASA physical status I , II , and III patients scheduled for elective coloproctological surgery .
METHODS	Patients were randomized to receive via a thoracic epidural catheter either a ) bupivacaine 0.25 % ( 10 mL ) and saline 0.9 % ( 2 mL ) as a bolus followed by an infusion of bupivacaine 0.25 % ( 5 mL/hr ) or b ) bupivacaine 0.25 % ( 10 mL ) and morphine 0.1 % ( 2 mL ) as a bolus followed by an infusion of bupivacaine 0.25 % plus morphine 0.025 % ( 5 mL/hr ) .
METHODS	Anesthesia was induced with propofol , fentanyl 2 microg kg ( -1 ) and atracurium and maintained with sevoflurane and nitrous oxide in oxygen .
METHODS	Sevoflurane level was titrated to maintain a BIS value between 40 and 50 .
METHODS	After extubation , patients were asked about the presence of pain .
RESULTS	There was no significant difference between groups of end-tidal sevoflurane concentrations at identical BIS values and hemodynamic values at any time in the study .
RESULTS	However , the morphine group had a lower pain score level at extubation than did the plain bupivacaine group ( no pain on movement , 79 % vs. 31.5 % , p < 0.01 ) .
CONCLUSIONS	Adding morphine to the bupivacaine epidural solution did not reduce sevoflurane requirements but did provide high-quality postoperative analgesia , mainly just after tracheal extubation .

###25575420
OBJECTIVE	To compare functional outcomes of 7-year-old ( school-age ) children born small for gestational age ( SGA ; ie , a birth weight z score -1 SD ) , with appropriate for gestational age ( AGA ) peers , born moderately preterm or full term .
METHODS	Data were collected as part of the Longitudinal Preterm Outcome Project study , a community-based , prospective cohort study of 336 AGA and 42 SGA born children ( median gestational age 35 weeks , range 31-41 ) .
METHODS	Of the SGA children , 32 were moderately preterm , 10 were full term ; of the AGA , these numbers were 216 and 120 , respectively .
METHODS	At 6.9 years , we assessed intelligence , verbal memory , attention , visuomotor integration , and motor skills and we collected the parent-reported executive functioning .
METHODS	We compared the outcomes of the SGA children with those of their AGA peers .
RESULTS	The performance of SGA children was similar to that of their AGA peers , except for attention control which was abnormal more often in SGA children ( OR 3.99 , 95 % CI 1.32-12 .12 ) .
RESULTS	The IQ of SGA children was 3 points lower , but this difference failed to reach significance .
CONCLUSIONS	At school age , children born SGA have a greater risk of abnormal test scores on attention control than children born AGA , independent of gestational age .
CONCLUSIONS	Their motor and many other cognitive functions are similar .
CONCLUSIONS	The impact of these outcomes seems limited .
CONCLUSIONS	Nevertheless , the consequences for school performance deserve attention .

###16227798
OBJECTIVE	To evaluate the effects of an HIV prevention intervention with social networks of young men who have sex with men ( YMSM ) in St. Petersburg , Russia and Sofia , Bulgaria .
METHODS	A two-arm randomized trial with a longitudinally-followed community cohort .
METHODS	Fifty-two MSM social networks were recruited through access points in high-risk community venues .
METHODS	Network members ( n = 276 ) were assessed to determine risk characteristics , administered sociometric measures to empirically identify the social leader of each network , and counseled in risk reduction .
METHODS	The leaders of 25 experimental condition networks attended a nine-session program that provided training and guidance in delivering ongoing theory-based HIV prevention advice to other network members .
METHODS	Leaders successively targeted network members ' AIDS risk-related knowledge and risk reduction norms , attitudes , intentions , and self-efficacy .
METHODS	Participants were re-administered risk assessment measures at 3 - and 12-month follow-ups .
RESULTS	Among changes produced , the percentage of experimental network members reporting unprotected intercourse ( UI ) declined from 71.8 to 48.4 % at 3-month follow up ( P = 0.0001 ) .
RESULTS	The percentage who engaged in UI with multiple partners reduced from 31.5 to 12.9 % ( P = 0.02 ) .
RESULTS	After 12 months , the effects became attenuated but remained among participants who had multiple recent sexual partners , the most vulnerable group .
RESULTS	Little change was found in control group networks .
CONCLUSIONS	Interventions that engage the identified influence leaders of at-risk YMSM social networks to communicate theory-based counseling and advice can produce significant sexual risk behavior change .
CONCLUSIONS	This model is culturally pertinent for HIV prevention efforts in former socialist countries , as well as elsewhere for other hard-to-reach vulnerable community populations .

###18582308
BACKGROUND	Spinal anesthesia with the local anesthetic lidocaine has come under scrutiny because it is associated with transient neurologic symptoms ( TNS ) .
BACKGROUND	Although TNS is not associated with either lidocaine concentration or dose , its incidence has never been examined with very small doses of hyperbaric spinal lidocaine in patients in the lithotomy position .
BACKGROUND	We designed this study prospectively to compare the efficacy of low-dose 15 mg/ml with low-dose 20 mg/ml hyperbaric lidocaine in patients undergoing elective outpatient surgery in the lithotomy position .
METHODS	A total of 100 patients were randomized to receive either 30 mg of 15 mg/ml or the same dose of 20 mg/ml hyperbaric lidocaine .
METHODS	Lidocaine density at 37 degrees C is 1.0241 g/ml for the 15 mg/ml and 1.0260 g/ml for the 20 mg/ml solution .
METHODS	Patients were examined for motor block , sensory block , and block duration .
METHODS	Patients were contacted at 24 , 48 and 72 h and questioned about their perceptions of pain after the spinal anesthesia with specific questions designed to diagnose TNS .
RESULTS	The spread of analgesia was the same with both solutions of lidocaine .
RESULTS	Motor block was incomplete in all patients in both groups .
RESULTS	TNS were not observed when low doses of both solutions of lidocaine with dextrose were used in these ambulatory patients in the lithotomy position .
CONCLUSIONS	Hyperbaric lidocaine results in rapid recovery from sensory block and motor blockade .
CONCLUSIONS	It may have advantages for patients in a day-case setting .
CONCLUSIONS	No patients complained of TNS after discharge .

###17214057
BACKGROUND	Amifostine has a potential role for salivary gland protection in head and neck cancer patients who had radiotherapy .
METHODS	Sixty-seven head and neck cancer patients were randomized to receive radiotherapy or radiotherapy plus Amifostine .
METHODS	The efficacy of the treatment was determined by a questionnaire evaluating dryness of mouth and the oral comfort , the RTOG/EORTC acute/late radiation morbidity scoring criteria , collection of the whole saliva and the 99mTc-pertecnetate scintigraphy of the salivary glands .
RESULTS	Amifostine significantly reduced the mean questionnaire scores from 6.49 to 3.73 , the incidence of grade > or = 2 mucositis from 75 % to 36 % and acute xerostomia from 82 % to 39 % .
RESULTS	The salivary gland function returned to normal at a rate of 36.3 % in the Amifostine group versus 9.1 % in the control group .
CONCLUSIONS	Amifostine is effective in reducing the incidence and severity of acute mucositis , acute and late xerostomia in head and neck cancer patients .

###19568205
OBJECTIVE	Exercise is a possible means to increase resting energy expenditure , which could offset age-related metabolic declines and facilitate weight management , both of which are particularly important for people who have type 2 diabetes mellitus .
OBJECTIVE	We sought to determine the effects of aerobic exercise training and resistance exercise training and the incremental effect of combined aerobic and resistance exercise training on resting metabolic rate ( RMR ) in previously sedentary individuals with type 2 diabetes .
METHODS	After a 4-wk run-in period , 103 participants ( 72 male , 31 female , 39-70 yr , mean + / - SD body mass index = 32.9 + / - 5.7 kg x m ( -2 ) ) were randomly assigned to four groups for 22 wk : aerobic training , resistance training , combined aerobic and resistance exercise training , or waiting-list control .
METHODS	Exercise training was performed three times per week at community-based gym facilities .
METHODS	RMR was measured by indirect calorimetry for 30 min after an overnight fast .
METHODS	Body composition was assessed using bioelectrical impedance .
METHODS	These measurements were taken at baseline , at 3 months , and at 6 months of the intervention .
RESULTS	RMR did not change significantly in any group after accounting for multiple comparisons despite significant improvements in peak oxygen consumption and muscular strength in the exercising groups .
RESULTS	Adjusting RMR for age , sex , fat mass , and fat-free mass in various combinations did not alter these results .
CONCLUSIONS	These results suggest that RMR was not significantly changed after a 6-month exercise program , regardless of modality , in this sample of adults with type 2 diabetes .

###23963688
OBJECTIVE	To verify the hypothesis that erythrocytes play a role in suboptimal blood platelet response to acetylsalicylic acid ( ASA , aspirin ) in subjects with coronary artery disease ( CAD ) .
METHODS	In a cross-over randomized controlled intervention study we evaluated blood platelet response to 30-day treatment with 75mg/d or 150mg/d of ASA ( enteric coated ) in CAD patients ( n = 125 ) .
METHODS	In vitro platelet response to collagen or arachidonic acid was monitored with impedance aggregometry and plasma thromboxane B2 was assayed immunoenzymatically .
METHODS	Blood morphology and several plasma biochemical parameters were determined using routine diagnostic procedures .
RESULTS	CAD patients demonstrated lower blood platelet responsiveness to 75mg/d of ASA compared to healthy subjects .
RESULTS	The improved platelet responsiveness to 150mg/d of ASA was particularly evident in `` poor '' responding patients .
RESULTS	Positive correlations between platelet `` poor '' response to lower ( 75mg/d ) ASA dose and red blood cell count ( Rs = 0.215 ; p < 0.04 ) , haemoglobin ( Rs = 0.232 ; p < 0.02 ) and haematocrit ( Rs = 0.239 ; p < 0.02 ) were found in CAD patients .
RESULTS	Association between `` poor '' platelet response with lower ASA dose was confirmed by conditional maximum likelihood logistic regression , which showed the independency between erythrocyte-derived parameters , as the risk factors for suboptimal platelet response to ASA , and other risk factors , like CRP or LDL-cholesterol .
RESULTS	In `` poor '' ASA responders taking the higher ASA dose ( 150mg/d ) the correlation between platelets ' response to ASA and erythrocyte-derived parameters was not significant .
CONCLUSIONS	Red blood cell parameters are associated with suboptimal blood platelet response to ASA in patients with CAD .
CONCLUSIONS	Such a platelet refractoriness to ASA may be effectively overcome by increasing the ASA dose .

###18706557
OBJECTIVE	To evaluate the effects of low-dose oral hormone therapy and nonoral hormone therapy on endothelial function markers and on anthropometric , metabolic , and hormonal variables in early postmenopausal women .
METHODS	Cross-over , randomized clinical trial .
METHODS	Gynecological Endocrinology Unit .
METHODS	Healthy postmenopausal women .
METHODS	Twenty patients received oral E ( 2 ) 1 mg plus drospirenone 2 mg/d for 2 months .
METHODS	Another group of 20 patients received 3 mg/d 17beta intranasal E ( 2 ) , and then 200 mg/d vaginal micronized P for 14 days during two 28-day cycles .
METHODS	At the end of this period , the patients were crossed over for another 2 months .
METHODS	Endothelial function markers and anthropometric , metabolic , and hormonal variables before and after hormone therapy .
RESULTS	Mean age was 51.2 + / - 2.7 years .
RESULTS	Mean time since menopause was 23.1 + / - 10 months .
RESULTS	After low-dose treatment , a reduction in waist circumference , waist-to-hip ratio , and high-density-lipoprotein cholesterol was observed .
RESULTS	Triglycerides and von Willebrand factor levels decreased significantly with nonoral treatment .
RESULTS	Fasting glucose and insulin levels did not change .
RESULTS	In both groups , total and non-high-density-lipoprotein cholesterol levels decreased below basal levels , and endothelin-1 , fibrinogen , and C-reactive protein levels remained unchanged .
CONCLUSIONS	Neither treatment induced deleterious effects in the short term on variables related to cardiovascular risk in early postmenopausal women .

###9058219
OBJECTIVE	The present study evaluated the effects of the nucleoside transport inhibitor , lidoflazine , at a dose of 1 mg/kg , on left ventricular function .
METHODS	Patients were randomly assigned to receive either lidoflazine or saline in a double-blind manner .
METHODS	A university hospital .
METHODS	The study was performed in 32 patients scheduled for elective coronary artery bypass surgery .
METHODS	Left ventricular pressures were measured with fluid-filled catheters .
METHODS	Data were digitally recorded during pressure elevation induced by tilt-up of the legs .
METHODS	Transgastric short-axis echocardiographic views of the left ventricle were simultaneously recorded on videotape .
METHODS	Systolic function was evaluated with the slope ( Ees , mmHg/mL ) of the systolic pressure-volume relationship .
METHODS	Diastolic function was evaluated with the chamber stiffness constant ( Kc , mmHg/mL ) of the diastolic pressure-volume relationship .
METHODS	Cardiac function was assessed at baseline and after administration of either lidoflazine ( group A [ n = 16 ] ) or placebo ( group B [ n = 16 ] ) .
METHODS	Data were compared using two-factor analysis of variance .
RESULTS	At baseline , diastolic and systolic function were comparable in both groups .
RESULTS	Lidoflazine increased Kc from 0.079 + / - 0.015 to 0.125 + / - 0.017 mmHg/mL and decreased Ees from 2.481 + / - 0.213 to 1.217 + / - 0.211 mmHg/mL ( p = 0.009 and p = 0.004 , respectively ) .
RESULTS	None of these changes occurred when placebo was administered .
CONCLUSIONS	Administration of lidoflazine before the start of cardiopulmonary bypass impaired left ventricular systolic function but also increased diastolic stiffness .

###18318773
BACKGROUND	The phosphodiesterase ( PDE ) type 5 inhibitor is a widely used agent that facilitates penile erection .
BACKGROUND	Udenafil is newly developed as a PDE-5 inhibitor .
CONCLUSIONS	This is the first study to determine the safety , tolerability and pharmacokinetics of udenafil in healthy subjects .
CONCLUSIONS	Udenafil was safe and well tolerated in healthy Korean subjects .
CONCLUSIONS	The AUC and C ( max ) of udenafil increased supraproportionally with increasing dose upon single administration , but there was no significant drug accumulation upon multiple administrations .
OBJECTIVE	To evaluate the safety , tolerability and pharmacokinetics ( PK ) of udenafil , a novel phosphodiesterase type 5 inhibitor .
METHODS	A double-blind , randomized , placebo-controlled , dose-rising , parallel-group , single - and multiple-dose study was conducted in healthy Korean subjects .
METHODS	The subjects were allocated to single-dose groups of 25 , 50 , 100 , 200 or 300 mg ( eight subjects in each dose group , including two placebos ) , or to multiple-dose groups of 100 or 200 mg ( once-daily dosing for 7 days ; nine subjects in each dose group , including three placebos ) .
METHODS	Serial samples of blood and urine were collected after oral administration and the drug concentrations in plasma and urine were determined by high-performance liquid chromatography .
METHODS	Safety and tolerability were evaluated by monitoring clinical laboratory parameters and adverse events .
RESULTS	Udenafil reached peak plasma concentrations at 0.8-1 .3 h , and then declined mono-exponentially with a terminal half-life of 7.3-12 .1 h in the single-dose study .
RESULTS	The area under the time-concentration curves ( AUC ) and maximum plasma concentrations ( C ( max ) ) increased supraproportionally with increasing dose in the single-dose study .
RESULTS	During multiple dosing , a steady state was reached at 5 days and little accumulation occurred after repeated dosing for 7 days .
RESULTS	Udenafil was generally well tolerated in these healthy subjects , and no serious adverse events occurred .
CONCLUSIONS	Udenafil was safe and well tolerated in healthy volunteers .
CONCLUSIONS	The AUC and C ( max ) of udenafil increased supraproportionally with increasing dose upon single administration , but there was no significant drug accumulation upon multiple administrations .

###8859136
OBJECTIVE	To determine whether premedication for lumbar puncture ( LP ) with lidocaine hinders collection of cerebrospinal fluid ( CSF ) through either increased number of attempts or increased incidence of traumatic punctures .
METHODS	A randomized controlled trial .
METHODS	The pediatric emergency department of an innercity teaching hospital .
METHODS	A convenience sample of 100 children , younger than 3 years , who required an LP as part of their diagnostic workup .
METHODS	Patients were randomized to receive either lidocaine or no local anesthetic before undergoing an LP .
METHODS	Comparison of the number of attempts needed to obtain CSF and the number of traumatic LPs between the lidocaine-treated and no local anesthetic groups .
RESULTS	The 51 patients randomized to receive lidocaine did not differ markedly in age from the 49 patients randomized to receive no local anesthetic .
RESULTS	Ease of obtaining CSF , as measured by number of attempts , did not differ with 59 % of the patients in each group requiring 1 attempt .
RESULTS	Defining a traumatic LP as more than 1000 x 10 ( 6 ) / L red blood cells in the CSF showed notably more traumatic LPs in the lidocaine-treated group .
RESULTS	Defining a traumatic LP as one with more than 10,000 x 10 ( 6 ) / L red blood cells in the CSF showed no significant difference in the number of traumatic LPs whether or not the patient was premedicated with lidocaine .
RESULTS	The level of experience of the physician performing the LP did not affect the outcome .
CONCLUSIONS	Premedication with lidocaine for an LP does not binder the ease of obtaining CSF .
CONCLUSIONS	The clinical relevance of a greater number of traumatic LPs in the lidocaine-treated group is questionable because this finding is negated when traumatic is defined as more than 10,000 x 10 ( 6 ) / L CSF red blood cells .
CONCLUSIONS	Based on these results , we advocate premedication with a local anesthetic when an LP is performed in the pediatric emergency department .

###18442690
OBJECTIVE	The purpose of this prospective randomized study was to assess biomechanical , radiographic , and functional results after single-bundle anterior cruciate ligament ( ACL ) reconstruction by use of a navigation system .
METHODS	ACL reconstruction was performed by use of the OrthoPilot navigation system ( B. Braun-Aesculap , Tuttlingen , Germany ) in 40 patients ( group 1 ) ; and in another 40 patients , surgery was done by the standard manual targeting technique ( group 2 ) .
METHODS	The anterior laxity was measured with a KT-1000 arthrometer ( MEDmetric , San Diego , CA ) .
METHODS	Femoral and tibial tunnel position was evaluated radiologically according to the method described by Bernard and Hertel and by Harner et al. , respectively .
METHODS	The questionnaire-based Lysholm and International Knee Documentation Committee scales were included to compare the functional state in both groups .
RESULTS	The knees in group 1 were as stable as those in group 2 during the arthrometer testing , with a lower value of dispersion .
RESULTS	The postoperative Lysholm and International Knee Documentation Committee scores had the same value in both groups .
RESULTS	Statistical differences existed with regard to anterior-posterior femoral tunnel placement when the navigated and standard techniques were compared ; in the navigated group , more exact results were found .
RESULTS	No significant complications were observed .
CONCLUSIONS	The only difference that we found between the navigated and standard groups was in radiographic tunnel position measurement .
CONCLUSIONS	The computer-assisted navigation technique in our study resulted in more accurate tunnel placement in the femur ( but not the tibia ) than the traditional arthroscopic technique .
CONCLUSIONS	However , the performed standard radiographic measurements are of limited precision in principle .
CONCLUSIONS	Functional scales and stability tests gave similar results in both groups .
METHODS	Level I , therapeutic study .

###11838820
OBJECTIVE	To describe the methodological challenges and decisions made in developing a multisite , controlled study of risperidone in children and adolescents with autism .
METHODS	Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums , aggressive and/or self-injurious behaviors .
METHODS	These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short - and long-term effects .
METHODS	Additional ethical and scientific issues concern the length of trial and sample size .
RESULTS	We undertook a short-term , placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder .
RESULTS	This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety .
RESULTS	Finally , a placebo-controlled discontinuation study tested the need for continuous treatment .
CONCLUSIONS	In the absence of standard pharmacological treatment for children with autistic disorder , a placebo-controlled study remains the most appropriate method of testing efficacy and safety .
CONCLUSIONS	The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation .

###24597915
BACKGROUND	Sexual risk is an important , oft-neglected area in addiction treatment .
OBJECTIVE	This report examines computerized sexual risk assessment and client feedback at intake as means of enhancing counselor awareness of client risk behavior during early treatment , as well as any clinical impact of that counselor awareness .
METHODS	In 2009-2011 , new clients at both opiate treatment and drug-free treatment programs endorsed in a computer-assisted assessment at intake 90-day retrospective indices for : being sexually active , having multiple partners , having sex under drug influence , and inconsistently using condoms .
METHODS	Clients were randomly assigned in a 2:1 ratio to receive or not receive a personal feedback report , and those receiving a report chose if a counselor copy was also distributed .
METHODS	Ninety days later , retained clients ( N = 79 ) repeated the assessment and their counselors concurrently reported perceptions of recent client risk behavior .
RESULTS	Based on client reports , pretreatment risk behaviors were prevalent among men and women and remained so during treatment .
RESULTS	A general linear model revealed greater counselor awareness of subsequent client risk behavior with mutual distribution of intake feedback reports to client and counselor , and at the opiate treatment program .
RESULTS	A repeated-measures analysis of variance indicated that counselor awareness did not predict change in temporally stable patterns of sexual risk behavior .
RESULTS	CONCLUSIONS/IMPORTANCE : Findings document that computerized intake assessment of sexual risk and mutually distributed feedback reports prompt greater counselor awareness of clients ' subsequent risk behavior .
RESULTS	Future research is needed to determine how best to prepare counselors to use such awareness to effectively prompt risk reduction in routine care .

###11414348
OBJECTIVE	Knowledge of treatment response for alcohol and drug problems among adults is mounting ; less is known about long-term outcome for adolescents who receive treatment for alcohol and drug problems .
OBJECTIVE	The current study examined youth substance involvement over 4 years ( using five waves of data collection ) following treatment for alcohol and drug abuse .
METHODS	A cohort of youth ( N = 162 , 60 % male ) treated during adolescence ( mean age = 16 years ) was followed into young adulthood , a period associated with stabilization of alcohol use patterns and elevated risk for life problems secondary to both alcohol and drug use .
METHODS	Participants ( 14-18 years old ) were consecutive admissions to inpatient adolescent alcohol and drug treatment centers in San Diego that were abstinence focused and based on the 12-step approach .
RESULTS	Alcohol and other drug use were reduced during the 4 years posttreatment , with the exception of nicotine .
RESULTS	The greatest prevalence reduction occurred for stimulants ; modest changes were evident in alcohol and marijuana use .
RESULTS	Nicotine was the most commonly used substance throughout the 4 years after treatment .
RESULTS	Several distinct substance involvement trajectories were evident during the 4 years following treatment .
CONCLUSIONS	Alcohol and drug use patterns during the 4 years following treatment highlight both changes and diversity in substance involvement as youth make the transitions from middle to late adolescence and into young adulthood .
CONCLUSIONS	Findings demonstrate the importance of identifying transitional periods and the need for alternative intervention strategies that may help the progression of this population into young adulthood .

###18378519
BACKGROUND	Whether the treatment of patients with hypertension who are 80 years of age or older is beneficial is unclear .
BACKGROUND	It has been suggested that antihypertensive therapy may reduce the risk of stroke , despite possibly increasing the risk of death .
METHODS	We randomly assigned 3845 patients from Europe , China , Australasia , and Tunisia who were 80 years of age or older and had a sustained systolic blood pressure of 160 mm Hg or more to receive either the diuretic indapamide ( sustained release , 1.5 mg ) or matching placebo .
METHODS	The angiotensin-converting-enzyme inhibitor perindopril ( 2 or 4 mg ) , or matching placebo , was added if necessary to achieve the target blood pressure of 150/80 mm Hg .
METHODS	The primary end point was fatal or nonfatal stroke .
RESULTS	The active-treatment group ( 1933 patients ) and the placebo group ( 1912 patients ) were well matched ( mean age , 83.6 years ; mean blood pressure while sitting , 173.0 / 90.8 mm Hg ) ; 11.8 % had a history of cardiovascular disease .
RESULTS	Median follow-up was 1.8 years .
RESULTS	At 2 years , the mean blood pressure while sitting was 15.0 / 6.1 mm Hg lower in the active-treatment group than in the placebo group .
RESULTS	In an intention-to-treat analysis , active treatment was associated with a 30 % reduction in the rate of fatal or nonfatal stroke ( 95 % confidence interval [ CI ] , -1 to 51 ; P = 0.06 ) , a 39 % reduction in the rate of death from stroke ( 95 % CI , 1 to 62 ; P = 0.05 ) , a 21 % reduction in the rate of death from any cause ( 95 % CI , 4 to 35 ; P = 0.02 ) , a 23 % reduction in the rate of death from cardiovascular causes ( 95 % CI , -1 to 40 ; P = 0.06 ) , and a 64 % reduction in the rate of heart failure ( 95 % CI , 42 to 78 ; P < 0.001 ) .
RESULTS	Fewer serious adverse events were reported in the active-treatment group ( 358 , vs. 448 in the placebo group ; P = 0.001 ) .
CONCLUSIONS	The results provide evidence that antihypertensive treatment with indapamide ( sustained release ) , with or without perindopril , in persons 80 years of age or older is beneficial .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00122811 [ ClinicalTrials.gov ] . )

###15539863
OBJECTIVE	To assess peripheral anti-H1 and central nervous system ( CNS ) activity of single increasing doses of rupatidine fumarate ( RU ) , a new antihistamine/platelet-activating factor antagonist compound , in comparison with hydroxyzine and placebo .
METHODS	Eighteen healthy young subjects of both sexes took part in a crossover , randomised , double-blind , placebo-controlled study .
METHODS	Treatments tested were : RU 10 , 20 , 40 and 80 mg and hydroxyzine 25 mg , as a positive standard .
METHODS	Before and several times after drug intake , peripheral anti-H1 activity was appraised by the skin reactivity to intradermal injection of histamine .
METHODS	CNS effects were also obtained by objective tests of psychomotor performance and subjective mood scales .
RESULTS	All active treatments showed a significant reduction of the wheal and flare reaction in relation to placebo , RU displaying a potent dose-dependent inhibition pattern .
RESULTS	The global nonparametric Friedman test to changes from placebo in 15 objective variables from psychomotor performance showed a significant impairment of similar magnitude after hydroxyzine 25 mg ( p = 0.01 ) and RU 80 mg ( p = 0.02 ) , but this was slower in development and recovery after the latter .
RESULTS	After RU 40 mg , a smaller impairment was also obtained ( p = 0.04 ) .
RESULTS	Activity ( p = 0.01 ) and drowsiness ( p = 0.02 ) scales showed significant changes , the subjects feeling less active and more drowsy after all active treatments .
CONCLUSIONS	RU presents a potent dose-dependent peripheral anti-H1 activity , displaying psychomotor impairment activity only at the highest dose ( 80 mg ) , while therapeutically relevant lower doses ( 10 and 20 mg ) were similar to placebo .

###11745230
BACKGROUND	To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization ( TACE ) and percutaneous ethanol injection ( PEI ) is superior to PEI alone in the treatment of patients with small hepatocellular carcinoma ( HCC ) , a randomized controlled study was performed .
METHODS	Fifty-two patients with one to three HCC tumors measuring < than 3 cm in greatest dimension were enrolled and underwent the combination TACE-PEI therapy ( 26 patients with 31 nodules ) or PEI alone ( 26 patients with 34 nodules ) .
METHODS	There were no significant differences in background between the two groups .
METHODS	The mean follow-up was 30.1 months + / - 17.5 months .
RESULTS	The cumulative detection rates of local residual disease in the TACE-PEI group ( 3.7 % at 1 year and 19.3 % at 3 years ) were significantly lower compared with the detection rates in the PEI alone group ( 34.2 % and 39.3 % , respectively ; P = 0.013 ) .
RESULTS	The cumulative new nodular recurrence rates in the TACE-PEI group ( 8.7 % at 1 year and 19.3 % at 3 years ) tended to be lower compared with the recurrence rates in the PEI alone group ( 26.9 % and 80.1 % , respectively ; P = 0.057 ) .
RESULTS	The cumulative survival rates were not significantly different between the two groups ( TACE-PEI group : 100 % , 80.8 % , and 40.4 % at 1 year , 3 years , and 5 years , respectively ; PEI alone group : 91.3 % , 65.9 % , and 37.7 % , respectively ; P = 0.458 ) .
RESULTS	However , among the patients from each group with HCC tumors measuring < 2 cm , the survival rates in the TACE-PEI group were improved compared with the survival rates in the PEI alone group ( P < 0.01 ) in addition to the detection rates of local residual disease and the new nodular recurrence rates ( P < 0.01 and P = 0.047 , respectively ) .
RESULTS	The frequency of short-term and long-term adverse effects was not significantly different between the groups .
RESULTS	However , only two major complications ( biloma and ascites with pleural effusion ) were observed , both of which occurred in patients in the TACE-PEI group .
CONCLUSIONS	Combination therapy with TACE-PEI was superior to PEI alone in the treatment of patients with small HCC tumors , especially for patients with HCC tumors measuring < 2 cm in greatest dimension .

###14733779
BACKGROUND	It has been known that intra-cellular immunity is important for defense against viral infections and this function lies with interferon gamma ( INF-gamma ) .
BACKGROUND	Here we evaluated the role of IFN-gamma system in the pathogenesis of chronic hepatitis C ( CHC ) .
METHODS	The levels of interferon gamma receptor alpha ( IFNGR alpha ) on the peripheral lymphocyte membrane were assayed with flow cytometry .
METHODS	The plasma concentrations of the cytokines IFN-gamma and IL-10 in CHC patients and normal controls were assayed by enzyme-linked-immunosorbent assay ( ELISA ) .
METHODS	The samples were collected randomly from Xinjiang Autonomous Region , Zhejiang and the northern regions of Jiangsu Province in China .
RESULTS	The levels of IFNGR alpha in CHC patients were significantly lower than that of normal controls ( NC ) , especially among patients during the stable stage ( P < 0.001 ) , whereas there were no significant differences between CHC in active and stable stages .
RESULTS	Among the patients of the three regions , there were no significant differences between patients from Xinjiang and Zhejiang provinces , but both had statistically significant difference compared with the patients from Jiangsu Province ( P < 0.001 ) .
RESULTS	Plasma IFN-gamma and IL-10 concentrations in CHC patients decreased significantly , IFN-gamma in particular , but there were no significant differences in these levels between various stages of the disease .
RESULTS	The IFN-gamma/IL -10 ( Th1/Th2 ) ratio in patients was reversed .
CONCLUSIONS	There may be defects in the IFN-gamma system in chronic HCV infected subjects and a low immune response , which may play an important role in the persistence of HCV infection .

###23769278
OBJECTIVE	We aimed to assess the diagnostic accuracy of photodynamic diagnostic ureterorenoscopy ( PDD-FURS ) in detection of UUT-TCC in comparison with CT Urogram ( CTU ) and WL-FURS .
METHODS	Between June 2009 and August 2011 , 30 patients underwent PDD-FURS after CTU for suspicion of UUT-TCC .
METHODS	Ureterorenoscopy was performed for abnormal upper urinary tract on imaging .
METHODS	Oral 5-Aminolevulinic Acid ( 5-ALA ) was used as a photosensitizer .
METHODS	All procedures were performed by single endourologist experienced in photodynamic diagnosis .
METHODS	The sensitivity , specificity , and detection rate of WL-FURS , PDD-FURS and CTU were calculated using the Meta-DiSc v1 .4 programme .
METHODS	P values < 0.05 were considered significant .
RESULTS	PDD-FURS detected more UUT-TCCs than CTU or WL-FURS ( 94 % ( 16/17 ) vs. 76.5 % ( 13/17 ) vs. 82 % ( 14/17 ) respectively ) .
RESULTS	PDD-FURS was not significantly more sensitive than CTU and WL-FURS to detect UUT-TCC ( 0.94 ( 95 % CI : 0.71-0 .99 ) vs. 0.82 ( 95 % CI : 0.57-0 .96 ) vs. 0.81 ( 95 % CI : 0.54-0 .96 ) respectively ; PDD-FURS vs. CTU : P = 0.249 ; PDD-FURS vs. WL-FURS : P = 0.277 ) .
RESULTS	There was no difference in the specificity between PDD-FURS and WL-FURS ( 1.0 ( 95 % CI : 0.75-1 .0 ) and 1.0 ( 95 % CI : 0.75-1 .0 ) respectively ) ( P = 1 ) , while PDD-FURS was significantly more specific than CTU ( CTU : 0.21 ( 95 % CI : 0.05-0 .51 ) ( P < 0.001 ) .
RESULTS	PDD-FURS picked up 3 cases of CIS , which was not seen on WL-FURL and CTU .
CONCLUSIONS	Oral 5-ALA induced PDD-FURS has a high sensitivity and specificity to detect lesions and a higher detection rate to diagnose UUT-TCC than WL-FURS and CTU .
CONCLUSIONS	It appears to be the only tool to visualise UUT CIS lesions .

###9758071
OBJECTIVE	Pain-relieving effects of lidocaine/bupivicaine local anesthetic ( LA ) and saline ( S ) block of sympathetic ganglia ( stellate block , 4 patients ; lumbar sympathetic block , 3 patients ) were compared in 7 complex regional pain syndrome ( CRPS ) patients on a double-blind crossover basis to evaluate the diagnostic and therapeutic value of local anesthetic sympathetic blocks .
METHODS	Patients rated their pain on a visual analog scale before and after blocks and were tested for mechanical allodynia one-half hour after blocks .
METHODS	Thereafter , they rated their pain intensity in diaries four times a day for 7 days .
METHODS	Each patient received two blocks , S and LA , and served as his own control .
RESULTS	Both S and LA injections of sympathetic ganglia produced large reductions in pain intensity in 6 of 7 patients 30 minutes after block .
RESULTS	These large reductions were accompanied by the reversal of mechanical allodynia in both S and LA. .
RESULTS	The mean difference between initial peak reduction in pain intensity produced by saline ( 68.7 % ) and active local anesthetic ( 74.4 % ) did not approach statistical significance .
RESULTS	In striking contrast , the mean duration of pain relief was reliably longer in the case of LA ( 3 days , 18 hours ) as compared with S ( 19.9 hours ) , a difference that occurred in all 7 patients .
RESULTS	In a larger sample of 41 CRPS patients , signs of sympathetic efferent blockade , including Homer ' s syndrome or skin surface temperature change , were not predictive of initial peak magnitude of pain relief from sympathetic blockade but were predictive of duration of pain reduction .
CONCLUSIONS	The combination of these results provides evidence that duration of pain relief is affected by injection of local anesthetics into sympathetic ganglia .
CONCLUSIONS	These results indicate that both magnitude and duration of pain reduction should be closely monitored to provide optimal efficacy in procedures that use local anesthetics to treat CRPS .

###24411681
BACKGROUND	Childbirth is an important experience in a woman 's life , and unfavorable birth experiences have been shown to negatively impact postpartum maternal health .
BACKGROUND	Aim of this study was to evaluate the effects of music therapy on postpartum pain , anxiety level , satisfaction and early pospartum depression rate .
METHODS	Totally 161 primiparous women were recruited and randomized either music group ( n = 80 ) or a control group ( n = 81 ) .
METHODS	Women in the music group listened to self-selected music during labor .
METHODS	Postpartum pain intensity , anxiety level and satisfaction rate were measured using the visual analog scale ( VAS ) , postpartum depression rate was assessed with Edinburg Postpartum Depression Scale ( EPDS ) at postpartum day one and day eight .
RESULTS	Mothers in the music therapy group had a lower level of postpartum pain and anxiety than the control group and it was statistically significant at all time intervals ( 1 , 4 , 8 , 16 and 24h , p < 0.001 ) .
RESULTS	A significant difference was observed between the two groups in terms of satisfaction rate ( p < 0.001 ) and postpartum depression rate at postpartum day one and day eight ( p < 0.05 ) .
CONCLUSIONS	We only measured the effect of music therapy on early postpartum depression rate .
CONCLUSIONS	Effect of music on late postpartum depression rate should be investigated in future .
CONCLUSIONS	Using music therapy during labor decreased postpartum anxiety and pain , increased the satisfaction with childbirth and reduced early postpartum depression rate .
CONCLUSIONS	Music therapy can be clinically recommended as an alternative , safe , easy and enjoyable nonpharmacological method for postpartum well-being .

###12935823
BACKGROUND	A third-generation troponin T assay with improved precision and a lower detection limit has been developed .
BACKGROUND	However , the appropriate cutoff for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality has not been established .
METHODS	A retrospective evaluation of data from the Fragmin and fast Revascularization during InStability in Coronary artery disease II ( FRISC-II ) trial suggested that a cutoff below 0.1 microg/L for troponin T levels might be more useful in risk stratification .
METHODS	A prospective validation of two cutoff levels ( 0.03 microg/L and 0.01 microg/L ) was performed in 7115 patients with non-ST-elevation acute coronary syndrome from the Global Utilization of Strategies To open Occluded arteries IV ( GUSTO-IV ) trial .
RESULTS	Patients with troponin T levels > 0.1 microg/L had greater 30-day mortality ( 5.5 % [ 201/3679 ] ) than did those with levels < or = 0.1 microg/L ( 2.2 % [ 75/3436 ] , P < 0.001 ) .
RESULTS	A cutoff value of 0.03 microg/L provided better discrimination between high and low risk : 5.1 % ( 234/4552 ) versus 1.6 % ( 42/2563 ) .
RESULTS	However , a cutoff value at the lower limit of detection , 0.01 microg/L , provided the best discrimination : 5.0 % ( 254/5123 ) versus 1.1 % ( 22/1992 ) ( P < 0.001 ) .
RESULTS	This cutoff level had the highest negative predictive value ; it also discriminated best for the combined endpoint of death and myocardial infarction .
CONCLUSIONS	Using a cutoff of < or = 0.01 microg/L for the third-generation troponin T assay , the detection level of the assay , is useful for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality .

###9820260
BACKGROUND	Irritable bowel syndrome ( IBS ) is a common functional bowel disorder for which there is no reliable medical treatment .
OBJECTIVE	To determine whether Chinese herbal medicine ( CHM ) is of any benefit in the treatment of IBS .
METHODS	Randomized , double-blind , placebo-controlled trial conducted during 1996 through 1997 .
METHODS	Patients were recruited through 2 teaching hospitals and 5 private practices of gastroenterologists , and received CHM in 3 Chinese herbal clinics .
METHODS	A total of 116 patients who fulfilled the Rome criteria , an established standard for diagnosis of IBS .
METHODS	Patients were randomly allocated to 1 of 3 treatment groups : individualized Chinese herbal formulations ( n = 38 ) , a standard Chinese herbal formulation ( n = 43 ) , or placebo ( n = 35 ) .
METHODS	Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist .
METHODS	Patients , gastroenterologists , and herbalists were all blinded to treatment group .
METHODS	Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients .
RESULTS	Compared with patients in the placebo group , patients in the active treatment groups ( standard and individualized CHM ) had significant improvement in bowel symptom scores as rated by patients ( P = .03 ) and by gastroenterologists ( P = .001 ) , and significant global improvement as rated by patients ( P = .007 ) and by gastroenterologists ( P = .002 ) .
RESULTS	Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms ( P = .03 ) .
RESULTS	Chinese herbal formulations individually tailored to the patient proved no more effective than standard CHM treatment .
RESULTS	On follow-up 14 weeks after completion of treatment , only the individualized CHM treatment group maintained improvement .
CONCLUSIONS	Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS .

###19559191
BACKGROUND	Clopidogrel and aspirin are the most popular antiplatelet agents for anticoagulation management after coronary artery bypass grafting ( CABG ) in clinical practice , but there is neither a standard antiplatelet therapy for patients undergoing CABG , nor an exact conclusion about its effects on graft patency until now .
METHODS	One-hundred and ninety-seven selected patients undergoing CABG were assigned to two groups according to antiplatelet drug : the clopidogrel group of 102 patients who received clopidogrel ( 75 mg ) daily ; and the combination group of 95 patients who received clopidogrel ( 75 mg ) plus aspirin ( 100 mg ) daily .
METHODS	Multislice computed tomography angiography was performed to evaluate graft patency at 1 month and 12 months after CABG .
RESULTS	There were no significant differences between the two groups in preoperational data .
RESULTS	At 1 month and 12 months after CABG graft patency rates of clopidogrel group were , respectively , 99.0 % and 96.9 % for the left internal mammary artery ( LIMA ) and 98.1 % and 93.5 % for the saphenous vein grafts ; those of the combination group were , respectively , 98.9 % and 97.8 % for LIMA , and 98.2 % and 96.3 % for saphenous vein grafts .
RESULTS	There were no significant differences in graft patency between the two groups ( p > 0.05 ) .
CONCLUSIONS	Either clopidogrel plus aspirin or clopidogrel alone maintain high graft patency in the early postoperative phase after CABG .
CONCLUSIONS	The observed trend toward higher patency rates in patients treated with clopidogrel plus aspirin compared to those in the clopidogrel group did not reach statistical significance .

###9850017
OBJECTIVE	National Wilms ' Tumor Study ( NWTS ) -4 was designed to evaluate the efficacy , toxicity , and cost of the administration of different regimens for the treatment of Wilms ' tumor ( WT ) .
METHODS	Between August 6 , 1986 and September 1 , 1994 , 905 previously untreated children aged younger than 16 years with stage II favorable histology ( FH ) WT ( low-risk [ LR ] ) , stages III to IV FH WT , or stages I to IV clear-cell sarcoma of the kidney ( high-risk [ HR ] ) were randomized after the completion of 6 months of chemotherapy to discontinue ( short ) or continue for 9 additional months ( long ) treatment with chemotherapy regimens that included vincristine and either divided-dose ( standard [ STD ] ) courses ( 5 days ) or single-dose ( pulse-intensive [ PI ] ) treatment with dactinomycin .
METHODS	HR patients also received either divided-dose ( STD ) courses ( 3 days ) or single-dose ( PI ) treatment with doxorubicin .
RESULTS	The 4-year relapse-free survival ( RFS ) rates after the second randomization for LR patients were 83.7 % for the 190 patients treated with short and 88.2 % for the 187 patients treated with long chemotherapy ( P = .11 ) .
RESULTS	The 4-year RFS rates after the second randomization for HR FH patients were 89.7 % for the 256 patients treated with short and 88.8 % for the 246 patients treated with long chemotherapy ( P = .87 ) .
RESULTS	The charge for treatment with the short PI treatment regimens for all children with stages I through IV FH WT was approximately one half of that with the long STD treatment regimens .
CONCLUSIONS	The short administration schedule for the treatment of children with WT is no less effective than the long administration schedule and can be administered at a substantially lower total treatment cost .

###23633277
BACKGROUND	Commercial weight loss programs offer support to overweight and obese patients to reduce excess bodyweight .
BACKGROUND	Many patients seek advice for weight loss from their general practitioners .
METHODS	In the framework of a randomized controlled 1-year trial the effectiveness and safety of a commercial weight loss program was compared with a primary care intervention .
METHODS	At the end of the trial the participating general practitioners and study participants were asked to answer specific questions about their offered weight loss management .
METHODS	This paper relates to the German study part ( 268 participants , 40 general practitioners ) .
RESULTS	More than half of the general practitioners reported to offer a dietary concept which varied strongly across general practitioners .
RESULTS	About one third of the general practitioners considered commercial weight loss programs as an alternative to support weight reduction .
RESULTS	Participants reported that they considered weight loss advice by their general practitioners as helpful .
RESULTS	But patients in the commercial weight loss program assessed the advice as more positive and achieved twice as much weight loss as patients in the primary care intervention .
CONCLUSIONS	Evaluated commercial weight loss programs can be effective and safe alternatives for general practitioners to achieve weight loss in overweight and obese patients .

###15379144
BACKGROUND	In a prospective randomised trial we studied haemodynamic stability during induction of anaesthesia for CABG surgery in patients receiving remifentanil-propofol or fentanyl-propofol anaesthesia .
METHODS	Fifty-four patients scheduled for elective CABG surgery were studied .
METHODS	Anaesthesia was induced with propofol and pancuronium .
METHODS	The patients were randomly assigned to two groups according to the opioid used during the induction .
METHODS	The remifentanil group received 0.5 microg kg ( -1 ) min ( -1 ) of the drug and the fentanyl group received 5 microg kg ( -1 ) .
METHODS	We measured blood pressure , central venous pressure and heart rate continuously for 15 min before and 30 min after orotracheal intubation .
METHODS	We also recorded use of rescue medication for maintaining the mean arterial pressure between 65 and 85 mmHg .
RESULTS	After induction of anaesthesia the mean arterial pressure and heart rate decreased significantly in both groups ( P < 0.05 ) .
RESULTS	After orotracheal intubation the mean arterial pressure and heart rate increased significantly in the fentanyl group but not in the remifentanil group ( P < 0.05 ) .
RESULTS	The incidence of hypertonic events necessitating the use of rescue medication was significantly higher in the fentanyl group ( P < 0.05 ) .
CONCLUSIONS	Our results show more stable haemodynamics after induction of anaesthesia in CABG surgery in patients receiving remifentanil-propofol than in patients receiving fentanyl-propofol .

###14672246
BACKGROUND	Dieting in healthy women results in a decrease in the availability of tryptophan ( TRP ) , the amino-acid precursor of serotonin ( 5-HT ) , for brain 5-HT synthesis .
BACKGROUND	This is associated with increases in the prolactin response to 5-HT drug challenge suggesting a ` supersensitivity ' of 5-HT neuroendocrine responses .
BACKGROUND	The aim of the study was to assess whether increased TRP intake during dieting would prevent the changes in TRP availability and 5-HT neuroendocrine function .
METHODS	Fifty female subjects underwent a 1000 kcal daily diet for 3 weeks .
METHODS	In the final week of the diet subjects were randomly allocated to receive either nutritionally-sourced TRP ( 1.8 g daily ) or placebo in a double-blind , parallel group , design .
RESULTS	TRP supplementation failed to modify the dieting-induced reduction in fasting TRP availability to the brain .
RESULTS	However , in contrast to placebo-treated subjects , subjects receiving additional TRP did not show enhanced prolactin responses to intravenous TRP challenge .
CONCLUSIONS	The decrease in TRP availability produced by dieting may be due to increased TRP metabolism rather than decreased TRP intake .
CONCLUSIONS	While TRP treatment did not increase fasting TRP availability it may have modified the effect of dieting on brain 5-HT function .
CONCLUSIONS	Further studies will be needed to see if this effect of TRP has consequences for the effectiveness of dieting as means of weight control .

###18721455
BACKGROUND	Trauma is a major source of morbidity and mortality , especially in people below the age of 50 years .
BACKGROUND	For the evaluation of trauma patients CT scanning has gained wide acceptance in and provides detailed information on location and severity of injuries .
BACKGROUND	However , CT scanning is frequently time consuming due to logistical ( location of CT scanner elsewhere in the hospital ) and technical issues .
BACKGROUND	An innovative and unique infrastructural change has been made in the AMC in which the CT scanner is transported to the patient instead of the patient to the CT scanner .
BACKGROUND	As a consequence , early shockroom CT scanning provides an all-inclusive multifocal diagnostic modality that can detect ( potentially life-threatening ) injuries in an earlier stage , so that therapy can be directed based on these findings .
METHODS	The REACT-trial is a prospective , randomized trial , comparing two Dutch level-1 trauma centers , respectively the VUmc and AMC , with the only difference being the location of the CT scanner ( respectively in the Radiology Department and in the shockroom ) .
METHODS	All trauma patients that are transported to the AMC or VUmc shockroom according to the current prehospital triage system are included .
METHODS	Patients younger than 16 years of age and patients who die during transport are excluded .
METHODS	Randomization will be performed prehospitally .
METHODS	Study parameters are the number of days outside the hospital during the first year following the trauma ( primary outcome ) , general health at 6 and 12 months post trauma , mortality and morbidity , and various time intervals during initial evaluation .
METHODS	In addition a cost-effectiveness analysis of this shockroom concept will be performed .
METHODS	Regarding primary outcome it is estimated that the common standard deviation of days spent outside of the hospital during the first year following trauma is a total of 12 days .
METHODS	To detect an overall difference of 2 days within the first year between the two strategies , 562 patients per group are needed .
METHODS	( alpha 0.95 and beta 0.80 ) .
CONCLUSIONS	The REACT-trial will provide evidence on the effects of a strategy involving early shockroom CT scanning compared with a standard diagnostic imaging strategy in trauma patients on both patient outcome and operations research .
BACKGROUND	ISRCTN55332315 .

###18351303
OBJECTIVE	The aim of this randomized , single blind phase IIIb study was to evaluate the efficacy of 0.5 % levobupivacaine versus 0.5 % bupivacaine and 0.75 % ropivacaine administered as epidural anesthesia and 0.125 % levobupivacaine versus 0.125 % bupivacaine and 0.2 % ropivacaine for postoperative analgesia .
OBJECTIVE	The study was designed to test the equivalence of the overall profile of levobupivacaine against bupivacaine and ropivacaine .
OBJECTIVE	In addition , parameters of clinical safety were assessed .
METHODS	A total of 88 patients undergoing hip surgery at 12 German academic hospitals were randomly assigned to 3 different treatment groups .
METHODS	Criteria for drug evaluation were the required epidural volume and time until onset and offset of sensory and motor block , the quality of postoperative analgesia using a pain visual analogue scale and verbal rating scale , as well as the need for rescue medication based on statistical non-inferiority testing .
RESULTS	With respect to onset and offset of sensory and motor blockade , 0.5 % levobupivacaine , 0.5 % bupivacaine and 0.75 % ropivacaine showed clinically significant equivalent profiles for all primary study endpoints .
RESULTS	However , the levobupivacaine group showed a higher demand for intraoperative anesthesia .
RESULTS	Postoperative analgesia request and pain scales did not differ significantly between groups , but comparatively lower total drug volumes were required in the bupivacaine group .
RESULTS	No relevant differences between the trial groups concerning safety parameters were observed .
CONCLUSIONS	The efficacy of epidural levobupivacaine for hip surgery and postoperative analgesia is equivalent and shows a comparable clinical profile to bupivacaine and 50-60 % higher concentrated ropivacaine .
CONCLUSIONS	The results of this equivalence study confirm suggestions derived from previous comparative studies .

###18052559
OBJECTIVE	This study evaluated the efficacy and tolerability of desvenlafaxine succinate ( desvenlafaxine ) in the treatment of major depressive disorder ( MDD ) .
METHODS	In this 8-week , multicenter , randomized , double-blind , placebo-controlled trial , adult outpatients ( aged 18-75 years ) with a primary diagnosis of MDD ( DSM-IV criteria ) were randomly assigned to treatment with desvenlafaxine ( 100-200 mg/day ) or placebo .
METHODS	The primary outcome measure was the 17-item Hamilton Rating Scale for Depression ( HAM-D ( 17 ) ) score at final on-therapy evaluation .
METHODS	The Clinical Global Impressions-Improvement scale ( CGI-I ) was the key secondary measure .
METHODS	Other secondary measures included the Montgomery-Asberg Depression Rating Scale ( MADRS ) , Clinical Global Impressions-Severity of Illness scale , Visual Analog Scale-Pain Intensity ( VAS-PI ) overall and subcomponent scores , and HAM-D ( 17 ) response and remission rates .
METHODS	The study was conducted from June 2003 to May 2004 .
RESULTS	Of the 247 patients randomly assigned to treatment , 234 comprised the intent-to-treat population .
RESULTS	Following titration , mean daily desvenlafaxine doses ranged from 179 to 195 mg/day .
RESULTS	At endpoint , there were no significant differences in scores between the desvenlafaxine ( N = 120 ) and placebo ( N = 114 ) groups on the HAM-D ( 17 ) or CGI-I .
RESULTS	However , the desvenlafaxine group had significantly greater improvement in MADRS scores ( p = .047 ) and in VAS-PI overall pain ( p = .008 ) , back pain ( p = .006 ) , and arm , leg , or joint pain ( p < .001 ) scores than the placebo group .
RESULTS	The most common treatment-emergent adverse events ( at least 10 % and twice the rate of placebo ) were nausea , dry mouth , constipation , anorexia , somnolence , and nervousness .
CONCLUSIONS	Desvenlafaxine was generally safe and well tolerated .
CONCLUSIONS	In this study , it did not show significantly greater efficacy than placebo on the primary or key secondary efficacy endpoints , but it did demonstrate efficacy on an alternate depression scale and pain measure associated with MDD .
BACKGROUND	ClinicalTrials.gov identifier NCT00063206 .

###17213792
OBJECTIVE	In this study peak systolic velocity ( PSV ) was measured by penile duplex Doppler spectrum dynamic analysis in diabetic patients with erectile dysfunction ( ED ) administered continuous treatment with tadalafil for 3 months in a weekly regimen ( Monday-Wednesday-Friday ) .
OBJECTIVE	Responses to the Structured Interview on Erectile Dysfunction ( SIEDY ) questionnaire and hormonal blood levels ( LH , testosterone , prolactin ) were studied before and after treatment .
METHODS	The study sample was 20 diabetic patients ( mean age 60 years ; range 55-65 ) with organic vascular arterial ED at enrollment into the study .
METHODS	All patients were eligible for receiving tadalafil .
METHODS	Patients were randomly assigned to 2 different treatment groups according to a computer-generated list .
METHODS	The first random set of numbers was assigned to group A , the second to group B. Group A ( n = 10 ) received tadalafil 20 mg per os on demand for 3 months ( Cialis , Lilly ICOS ; London , UK ) .
METHODS	Group B ( n = 10 ) received tadalafil 20 mg per os on weekly fixed days ( Monday-Wednesday-Friday ) for 3 months .
METHODS	All patients underwent duplex penile sonographic dynamic evaluation after intracavernosal injection of alprostadil 20 microg ( Caverject , Pharmacia SpA ; Milan , Italy ) ; SIEDY questionnaire responses and changes in blood hormonal levels ( LH , testosterone , prolactin ) before and after treatment were compared .
RESULTS	Increased PSV at 10 min and 20 min after alprostadil administration was found in 30 % of Group A patients and in 60 % of Group B patients .
RESULTS	In 40 % of Group B patients , the increase in PSV was so significant as to justify reclassification to a less severe diagnostic category ( Benson classification ) in vascular profile .
RESULTS	No changes in hormonal levels after treatment were found in either group .
RESULTS	Analysis of the questionnaires showed a more marked reduction in the global total scores in Group B , with a greater frequency and a clearer improvement in global scores .
CONCLUSIONS	This study on a group of 20 patients with organic vascular arterial ED disclosed at least 2 basic aspects : 1 ) a higher percentage of Group B patients ( fixed-day treatment regimen ) showed a greater improvement in PSV than the controls ; 40 % of these patients were reclassified according to the Benson classification ; 2 ) within the context of a clinical study , monitoring and supportive care to increase the frequency and quality of sexual intercourse led to a resumption of and a greater interest in sexual activity .
CONCLUSIONS	This finding can not be explained by changes in hormonal levels ; instead , there appeared a sort of effect placebo that the continuous therapy , like conventional treatment for other health reasons , had on the patient .

###20546261
OBJECTIVE	The purpose of this sub-study of the Outcome Reduction with Initial Glargine Intervention ( ORIGIN ) trial was to determine efficacy and safety of targeting normal fasting plasma glucose ( FPG ) levels in patients with early Type 2 diabetes treated with insulin glargine in comparison with standard care .
METHODS	Participants were randomly allocated to insulin or standard care .
METHODS	Insulin was titrated to reach FPG < or = 5.3 mmol/l .
METHODS	Two years after randomization in a small subset ( 43 glargine , 32 standard care ) , continuous glucose measurement ( CGMS System Gold ) , including a test meal , was performed .
METHODS	Sixteen volunteers with normal oral glucose tolerance test ( OGTT ) served as control subjects .
METHODS	Objectives were glycaemic variability , standard deviation ( sd ) , mean amplitude of glucose excursion ( MAGE ) with postprandial glucose excursion after the test meal , time spent < 3.0 mmol/l interstitial glucose .
RESULTS	Participants allocated to insulin and standard care had FPG levels of 5.3 and 6.1 mmol/l ( P = 0.019 ) and glycated haemoglobin ( HbA ( 1c ) ) 5.7 % and 5.9 % , respectively ( P < 0.025 ) .
RESULTS	Time ( min/24 h ) spent at low glucose levels was not significantly different between groups ( 30.6 + / - 83.8 min control subjects , 33.7 + / - 75.1 min insulin , 10.6 + / - 50.6 min standard care ) .
RESULTS	Standard deviation and MAGE were similar for glargine and standard care , but significantly higher than in control subjects .
RESULTS	If FPG was < 5.3 mmol/l , the postprandial glucose excursion was in the range seen in control subjects .
CONCLUSIONS	Treatment to target of FPG < 5.3 mmol/l with insulin glargine was not associated with significantly increased risk of hypoglycaemia .
CONCLUSIONS	Strict control of FPG with insulin glargine was effective to control postprandial glucose excursion , but had no significant effect on sd and MAGE .

###15671968
OBJECTIVE	Nasal tampons are commonly used to stop bleeding , yet their insertion is painful .
OBJECTIVE	We compare the pain of insertion and removal of 2 commonly used nasal tampons .
METHODS	This was a prospective randomized controlled trial in 1 urban and 1 suburban emergency department ( ED ) .
METHODS	Subjects were a convenience sample of adult ED patients with active epistaxis requiring insertion of a nasal tampon , regardless of coagulation status .
METHODS	Pretreatment of the nasal mucosa was performed using an aerosolized lidocaine-Neo-Synephrine combination .
METHODS	Patients were randomized to tamponade with a single Rapid Rhino or Rhino Rocket nasal tampon .
METHODS	The pain and ease of insertion and success of tamponade were recorded .
METHODS	Tampon removal was performed after 1 to 3 days , and the pain and ease of removal , as well as the presence of any bleeding , were noted .
METHODS	Patients rated pain of insertion and removal on a previously validated 100-mm visual analogue pain scale ( 100 = worst pain ) .
METHODS	Physician ease of insertion and removal was recorded on a 5-point Likert scale .
METHODS	Continuous data are presented as means and 95 % confidence intervals ( CIs ) .
RESULTS	We evaluated 40 patients evenly distributed between study groups and sites .
RESULTS	Median patient age was 61 years ( interquartile range 48 to 79 years ) , and 33 % were female patients .
RESULTS	Coagulopathy was present in 10 ( 25 % ) patients .
RESULTS	Baseline characteristics were similar in both treatment groups .
RESULTS	The mean pain of insertion of the Rapid Rhino ( 30 mm , 95 % CI 18 to 41 mm ) was significantly less than with the Rhino Rocket ( 48 mm , 95 % CI 34 to 61 mm ; mean difference 18 mm , 95 % CI 1 to 35 mm ) .
RESULTS	The mean pain of removal of the Rapid Rhino ( 11 mm , 95 % CI 1 to 21 mm ) was also lower than with the Rhino Rocket ( 23 mm , 95 % CI 13 to 33 mm ; mean difference 12 mm , 95 % CI -1 to 25 mm ) .
RESULTS	The Rapid Rhino was also easier to insert and remove and had a lower incidence of recurrent bleeding after removal than the Rhino Rocket .
RESULTS	Rates of successful tamponade were similar in the 2 groups .
CONCLUSIONS	The Rapid Rhino nasal tampon is less painful to insert and easier to remove than the Rhino Rocket , whereas both are similarly effective at stopping nosebleeds .

###15916866
OBJECTIVE	To test the hypothesis that switching from L-methadone to D,L-methadone is associated with more frequent withdrawal symptoms and side-effects than switching from D,L-methadone to L-methadone .
METHODS	Stratified , randomized 2 x 2 crossover study design over a time-period of 8 weeks .
METHODS	At study entry , every second patient was switched from the pre-study substance to the other medication , after 4 weeks all patients were subject to a ( re - ) switch .
METHODS	The study was conducted as a multi-centre trial in three methadone maintenance therapy ( MMT ) clinics .
METHODS	Seventy-five patients previously treated with either D,L-methadone or L-methadone for at least 1 year took part in the study .
METHODS	Intra-individual changes in withdrawal symptoms ( Short Opiate Withdrawal Scale , SOWS ) and side-effects were defined as primary outcome criteria .
METHODS	Secondary outcome measures included necessity for methadone dose adjustment .
RESULTS	Complete data were available for 68 patients ( 91 % ) .
RESULTS	Sample strata were unbalanced at baseline : 15 patients ( 22 % ) were treated with L-methadone and 43 with D,L-methadone ( 78 % ) .
RESULTS	Thirty-five patients were randomized into the group treated with L-methadone and 33 into the group treated with D,L-methadone during the first 4 weeks .
RESULTS	There were no significant differences in intra-individual change of withdrawal symptoms and side-effects between groups after crossover .
RESULTS	However , patients treated with levomethadone tended to feel less withdrawal symptoms than patients treated with d,l-methadone .
CONCLUSIONS	D,L-methadone and L-methadone can safely be replaced by each other on a 2:1 ratio .
CONCLUSIONS	Withdrawal symptoms or side-effects due to conversion are of transient nature only .

###21319355
OBJECTIVE	Opioids may affect changes in the corrected QT interval ( QTc ) during anesthetic induction .
OBJECTIVE	This study examine whether a single bolus of remifentanil would prolong QTc after laryngeal mask airway ( LMA ) insertion during sevoflurane induction .
METHODS	Forty women of American Society of Anesthesiologists physical status 1 ( ASA PS1 ) undergoing gynecological surgery were studied .
METHODS	All patients were induced using three vital capacity inhalation inductions with 5 % sevoflurane .
METHODS	Two minutes after induction , the inspiratory concentration of sevoflurane was reduced to 2 % .
METHODS	Using double-blinded randomization , patients were allocated into one of two groups , receiving either saline ( placebo group , n = 20 ) or 0.25 g.kg remifentanil ( remifentanil group , n = 20 ) over a period of thirty seconds .
METHODS	Sixty seconds later , LMA insertion was performed .
METHODS	Recordings were taken with a 12-lead electrocardiogram at baseline , 2 min after induction and 1 and 3 min after LMA insertion .
METHODS	QTc was calculated by Bazett 's formula .
METHODS	The mean arterial pressure ( MAP ) and heart rate ( HR ) were also measured at each time point .
RESULTS	The QTc interval was significantly prolonged in the placebo group as compared to the remifentanil group at 1 min after LMA insertion ( 467.8 16.5 vs. 442.7 21.3 ms , p < 0.001 ) .
RESULTS	However , there was no significant difference in QTc at 3 min after LMA insertion between the two groups .
RESULTS	MAP and HR were significantly higher in the placebo group ( p < 0.001 ) .
CONCLUSIONS	A single bolus of remifentanil is safe method to attenuate prolonged QTc associated with insertion of LMA .

###9209989
OBJECTIVE	To determine whether intraoperative unpreserved lidocaine further decrease discomfort or pain during sutureless small incision cataract surgery and intraocular lens ( IOL ) implantation under topical anesthesia .
METHODS	Outpatient ambulatory surgical center .
METHODS	In this prospective controlled study , comparable eligible patients were randomized to receive 0.1 cc unpreserved lidocaine 1 % or 0.1 cc balanced salt solution ( BSS ) ( control group ) in double-masked fashion .
METHODS	Study drugs were injected intracamerally 1 minute before phacoemulsification .
METHODS	A predefined uniform pain/discomfort scale was used for assessment during phacoemulsification and IOL insertion .
METHODS	A secondary study using a 0.5 cc dose was also performed .
RESULTS	Twenty-six percent in the control group and 9 % in the lidocaine group had discomfort pain scores of 2 or more ; 10 % in the BSS group felt increased pressure or pain during phacoemulsification .
RESULTS	In the lidocaine group , discomfort was felt mainly during IOL insertion , possibly as a result of wound manipulation .
RESULTS	During phacoemulsification , no patient in the lidocaine group reported pain ; 2 % felt increased pressure during phacoemulsification .
RESULTS	A dose increase to 0.5 cc reduced any intraocular sensation to 3 % in the lidocaine group .
RESULTS	No patient in either group had significant cell loss or adverse events .
CONCLUSIONS	Intraoperative lidocaine is safe and effective in controlling intraoperative discomfort .

###11377155
OBJECTIVE	To compare the Bullard laryngoscope ( BL ) with the flexible fiberoptic bronchoscope ( FFB ) in a cervical spine injury model , using inline stabilization .
METHODS	Randomized clinical trial .
METHODS	Main operating room of a tertiary care hospital .
METHODS	50 adult , ASA physical status I , II , and III patients undergoing an elective general anesthetic .
METHODS	Each patient 's trachea was intubated with both techniques .
METHODS	Cricoid pressure was applied to half of the study patients .
METHODS	The time for laryngoscopic view and the time to intubation were recorded for each technique .
METHODS	The effects of cricoid pressure on laryngoscopic view and intubation time were determined .
RESULTS	The times for laryngoscopy and intubation were longer in the FFB group than in the BL group ( p < 0.004 ) .
RESULTS	There was a significantly lower success rate of laryngoscopy view in the FFB group in the presence of cricoid pressure ( 15 of 25 patients , or 60 % ) than either of the BL groups or the FFB no-cricoid pressure group .
CONCLUSIONS	The BL is more reliable , quicker , and more resistant to the effects of cricoid pressure than is the FFB .

###24305799
OBJECTIVE	The control of body lice in homeless persons remains a challenge .
OBJECTIVE	To determine whether the use of long-lasting insecticide-treated underwear provides effective long-term protection against body lice in homeless persons .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted in February and December 2011 in 2 homeless shelters ( Madrague Ville and Forbin ) in Marseille , France .
METHODS	Of the 125 homeless persons screened for eligibility , 73 body lice-infested homeless persons , 18 years or older , were enrolled .
METHODS	Body lice-infested homeless persons were randomly assigned to receive 0.4 % permethrin-impregnated underwear or an identical-appearing placebo for 45 days , in a 1:1 ratio , with a permuted block size of 10 .
METHODS	Visits were scheduled at days 14 and 45 .
METHODS	Data regarding the presence or absence of live body lice were collected .
METHODS	The primary and secondary end points were the proportions of homeless persons free of body lice on days 14 and 45 , respectively .
METHODS	Mutations associated with permethrin resistance in the body lice were also identified .
RESULTS	Significantly more homeless persons receiving permethrin-impregnated underwear than homeless persons receiving the placebo were free of body lice on day 14 in the intent-to-treat population ( 28 % vs 9 % ; P = .04 ) , with a between-group difference of 18.4 percentage points ( 95 % CI , 1.4-35 .4 ) , and in the per-protocol population ( 34 % vs 11 % ; P = .03 ) , with a between-group difference of 23.7 percentage points ( 95 % CI , 3.6-43 .7 ) .
RESULTS	This difference was not sustained on day 45 .
RESULTS	At baseline , the prevalence of the permethrin-resistant haplotype was 51 % in the permethrin group and 44 % in the placebo group .
RESULTS	On day 45 , the permethrin-resistant haplotype was significantly more frequent in the permethrin group than in the placebo group ( 73 % vs 45 % , P < .001 ) .
CONCLUSIONS	Permethrin-impregnated underwear is more efficient than placebo at eliminating body louse infestations by day 14 ; however , this difference was not sustained on day 45 .
CONCLUSIONS	The use of permethrin may have increased the resistance to permethrin in body lice and thus must be avoided .
BACKGROUND	clinicaltrials.gov Identifier : NCT01287663 .

###20937977
BACKGROUND	In the Postmenopausal Evaluation and Risk Reduction With Lasofoxifene ( PEARL ) trial , women assigned to lasofoxifene 0.5 mg/d had a lower risk of major coronary heart disease ( CHD ) events and stroke , whereas women assigned to lasofoxifene 0.25 mg/d had a lower risk of stroke .
BACKGROUND	Both doses of lasofoxifene increased the risk of venous thromboembolic events .
BACKGROUND	In this report , we provide comprehensive cardiovascular end-point data , including component events comprising the composite end point of major CHD events , and evaluate whether the effect of lasofoxifene 0.5 mg/d is consistent across different categories of CHD risk .
RESULTS	In this study , 8556 women 59 to 80 years of age with osteoporosis received lasofoxifene 0.25 mg/d , lasofoxifene 0.5 mg/d , or placebo for 5 years .
RESULTS	Cardiovascular events , including major CHD events , were prespecified secondary end points .
RESULTS	Compared with placebo , lasofoxifene 0.5 mg/d reduced the risk of major CHD events 32 % ( hazard ratio , 0.68 ; 95 % confidence interval , 0.50 to 0.93 ) , including the risk of coronary revascularization ( hazard ratio , 0.56 , 95 % confidence interval , 0.32 to 0.98 ) .
RESULTS	Reductions in risk of hospitalization for unstable angina ( hazard ratio , 0.55 ; 95 % confidence interval , 0.29 to 1.04 ) and diagnosis of new ischemic heart disease ( hazard ratio , 0.52 ; 95 % confidence interval , 0.26 to 1.04 ) nearly reached significance ( P = 0.06 for both comparisons ) .
RESULTS	Although both hazard ratios were < 1.0 , no significant effect of lasofoxifene at 0.5 mg/d was demonstrated for coronary death or nonfatal myocardial infarction .
RESULTS	The reduction in CHD events with lasofoxifene 0.25 mg/d was not significant ( hazard ratio , 0.76 ; 95 % confidence interval , 0.56 to 1.03 ; P = 0.08 ) .
RESULTS	The effectiveness of lasofoxifene 0.5 mg/d in reducing CHD events was similar across strata of major cardiovascular risk factors .
CONCLUSIONS	In postmenopausal women with osteoporosis , lasofoxifene 0.5 mg/d for 5 years reduced the risk of CHD events , regardless of the presence or absence of risk factors for cardiovascular disease .
CONCLUSIONS	The significant reduction in risk of CHD events with lasofoxifene 0.5 mg/d was due primarily to lower risks of coronary revascularization procedures , hospitalization for unstable angina , and diagnosis of new ischemic heart disease .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00141323 .

###16763797
BACKGROUND	The study was carried out to confirm the effect of calcium dobesilate ( CaD ) compared to placebo ( PLA ) on the blood-retinal barrier ( BRB ) permeability in early diabetic retinopathy ( DR ) .
METHODS	Adults with type II diabetes and early diabetic retinopathy ( below level 47 of ETDRS grading and PVPR between 20 and 50x10 ( -6 ) / min , plasma-free fluorescein ) were included in this double-blind placebo-controlled study .
METHODS	Treatment was 2 g daily for 24 months .
METHODS	The primary parameter , posterior vitreous penetration ratio ( PVPR ) , was measured every 6 months by fluorophotometry .
METHODS	Secondary parameters were fundus photography , fluorescein angiography and safety assessments .
METHODS	Metabolic control was performed every 3 months .
RESULTS	A total of 194 patients started the treatment ( 98 CaD , 96 PLA ) and 137 completed the 24-month study ( 69 CaD , 68 PLA ) .
RESULTS	Both treatment groups were comparable at baseline , with ETDRS level 10 in about 59 % of patients .
RESULTS	Mean PVPR change from baseline after 24 months was significantly ( P = 0.002 ) lower in the CaD group [ -3.87 ( SD 12.03 ) ] than in the PLA group [ +2.03 ( SD 12.86 ) ] , corresponding to a 13.2 % decrease in the CaD group and a 7.3 % increase in the PLA group .
RESULTS	PVPR evolution was also analysed by HbA1c classes ( < 7 % , between 7 and 9 % , > or = 9 % ) and results confirmed the superiority of CaD independently of the diabetes control level .
RESULTS	A highly significant difference [ CaD : -3.38 ( SD 13.44 ) versus PLA : +3.50 ( SD 13.70 ) ] was also obtained in a subgroup of patients without anti-hypertensive and/or lipid-lowering agents ( P = 0.002 at 24 months ) .
RESULTS	A further analysis of the secondary parameters showed significant changes in favour of CaD in the evolution from baseline to the last visit of haemorrhages ( P = 0.029 ) , DR level ( P = 0.0006 ) and microaneurysms ( P = 0.013 ) .
RESULTS	Regarding safety , only 2.5 % ( n = 5 patients / events ) of all adverse events reported were assessed as possibly or probably related to the test drug , while all serious adverse events were reported as unlikely .
RESULTS	There was no statistical difference between groups .
CONCLUSIONS	Calcium dobesilate 2 g daily for 2 years shows a significantly better activity than placebo on prevention of BRB disruption , independently of diabetes control .
CONCLUSIONS	Tolerance was very good .

###25646321
BACKGROUND	Epidemiology associates whole-grain ( WG ) consumption with several health benefits .
BACKGROUND	Mounting evidence suggests that WG wheat polyphenols play a role in mechanisms underlying health benefits .
OBJECTIVE	The objective was to assess circulating concentration , excretion , and the physiologic role of WG wheat polyphenols in subjects with suboptimal dietary and lifestyle behaviors .
METHODS	A placebo-controlled , parallel-group randomized trial with 80 healthy overweight/obese subjects with low intake of fruit and vegetables and sedentary lifestyle was performed .
METHODS	Participants replaced precise portions of refined wheat ( RW ) with a fixed amount of selected WG wheat or RW products for 8 wk .
METHODS	At baseline and every 4 wk , blood , urine , feces , and anthropometric and body composition measures were collected .
METHODS	Profiles of phenolic acids in biological samples , plasma markers of metabolic disease and inflammation , and fecal microbiota composition were assessed .
RESULTS	WG consumption for 4-8 wk determined a 4-fold increase in serum dihydroferulic acid ( DHFA ) and a 2-fold increase in fecal ferulic acid ( FA ) compared with RW consumption ( no changes ) .
RESULTS	Similarly , urinary FA at 8 wk doubled the baseline concentration only in WG subjects .
RESULTS	Concomitant reduction in plasma tumor necrosis factor - ( TNF - ) after 8 wk and increased interleukin ( IL ) -10 only after 4 wk with WG compared with RW ( P = 0.04 ) were observed .
RESULTS	No significant change in plasma metabolic disease markers over the study period was observed , but a trend toward lower plasma plasminogen activator inhibitor 1 with higher excretion of FA and DHFA in the WG group was found .
RESULTS	Fecal FA was associated with baseline low Bifidobacteriales and Bacteroidetes abundances , whereas after WG consumption , it correlated with increased Bacteroidetes and Firmicutes but reduced Clostridium .
RESULTS	TNF - reduction correlated with increased Bacteroides and Lactobacillus .
RESULTS	No effect of dietary interventions on anthropometric measurements and body composition was found .
CONCLUSIONS	WG wheat consumption significantly increased excreted FA and circulating DHFA .
CONCLUSIONS	Bacterial communities influenced fecal FA and were modified by WG wheat consumption .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01293175 .

###21216833
BACKGROUND	Osteoprotegerin ( OPG ) may be implicated in the pathogenesis of heart failure ( HF ) , and circulating levels predict survival in patients with postinfarction HF .
BACKGROUND	Our primary goal was to determine whether OPG provided independent prognostic information in patients with chronic HF , and to examine its potential interactions with statin therapy .
RESULTS	OPG as a risk factor for the primary end point ( cardiovascular death , nonfatal myocardial infarction , nonfatal stroke ; n = 318 ) , all-cause mortality ( n = 329 ) , and all-cause mortality/hospitalization for worsening of heart failure ( WHF ; n = 475 ) was investigated in 1464 patients ( 60 years , New York Heart Association class II to IV , ischemic systolic HF , optimal pharmacological therapy ) in the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) population , randomly assigned to 10 mg rosuvastatin or placebo .
RESULTS	In multivariate analyses , OPG ( continuous variable ) added no significant predictive information for risk estimation of the primary end point ( adjusting for left ventricular ejection fraction , New York Heart Association class , age , body mass index , diabetes , sex , intermittent claudication , heart rate , serum creatinine , apoA1 , and N-terminal pro-B-type natriuretic peptide ) .
RESULTS	However , OPG added independent predictive information for WHF hospitalization ( hazard ratio [ HR ] 1.10 [ 1.04 to 1.16 ] , P < 0.001 ) and all-cause mortality/WHF hospitalization ( HR 1.06 [ 1.01 to 1.11 ] ) .
RESULTS	The HR indicated a reduced risk for all-cause mortality in the rosuvastatin group in those with lowest OPG values ( tertile 1 , HR = 0.66 unadjusted [ P = 0.025 ] ; HR = 0.71 Cox adjusted [ P = 0.025 ] ; interaction by treatment effect for the tertiles P = 0.086 ) .
CONCLUSIONS	OPG added no predictive information for the primary end point , but independently predicted WHF hospitalization in older patients with advanced chronic systolic HF of ischemic etiology .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT00206310 .

###12682319
OBJECTIVE	To evaluate the efficacy and safety of risperidone in children and adults with Tourette syndrome .
METHODS	This was an 8-week , randomized , double-blind , placebo-controlled trial .
METHODS	The primary outcome measure was the Total Tic score of the Yale Global Tic Severity Scale ( YGTSS ) .
RESULTS	Thirty-four medication-free subjects ( 26 children and 8 adults ) ranging in age from 6 to 62 years ( mean = 19.7 + / - 17.0 years ) participated .
RESULTS	YGTSS Total Tic scores were similar at baseline ( 26.0 + / - 5.1 for risperidone vs 27.4 + / - 8.5 for placebo ) .
RESULTS	After 8 weeks of treatment ( mean daily dose of 2.5 + / - 0.85 ) , the 16 subjects on risperidone showed a 32 % reduction in tic severity from baseline , compared to a 7 % reduction for placebo patients ( n = 18 ) ( F [ 2,64 ] = 6.07 ; p = 0.004 ) .
RESULTS	The 12 children randomized to risperidone showed a 36 % reduction in tic symptoms compared to an 11 % decrease in the 14 children on placebo ( F [ 2,48 ] = 6.38 ; p = 0.004 ) .
RESULTS	Two children on risperidone showed acute social phobia , which resolved with dose reduction in one subject but resulted in medication discontinuation in the other .
RESULTS	A mean increase in body weight of 2.8 kg was observed in the risperidone group compared to no change in placebo ( F [ 2,64 ] = 10.68 ; p = 0.0001 ) .
RESULTS	No extrapyramidal symptoms and no clinically significant alterations in cardiac conduction times or laboratory measures were observed .
CONCLUSIONS	Risperidone appears to be safe and effective for short-term treatment of tics in children or adults with Tourette syndrome .
CONCLUSIONS	Longer-term studies are needed to evaluate the durability of efficacy and safety over time .

###10609719
OBJECTIVE	To compare the use of outpatient and inpatient procedures in the investigation of abnormal uterine bleeding .
METHODS	A randomised controlled trial .
METHODS	Two university teaching hospitals .
METHODS	Four hundred women with abnormal uterine bleeding ( postmenopausal bleeding , menorrhagia , intermenstrual bleeding , postcoital bleeding , or irregular periods ) above the age of 35 years , between June 1993 and January 1995 .
METHODS	1 .
METHODS	Incidence of detection of abnormal pathology by vaginal ultrasound , outpatient hysteroscopy and endometrial biopsy compared with inpatient hysteroscopy and curettage ; 2 .
METHODS	Number of ` lesions ' ( e.g. fibroids , polyps , endometrial hyperplasia or malignancy ) found by hysteroscopy that would have been missed by the combination of endometrial sampling and ultrasound ; 3 .
METHODS	Comparison of the quality of tissue obtained for histology by outpatient endometrial sampling and inpatient curettage ; and 4 .
METHODS	An evaluation of patient acceptability of outpatient and inpatient procedures .
RESULTS	1 .
RESULTS	A combination of transvaginal sonography , Pipelle endometrial biopsy and outpatient hysteroscopy has similar efficacy to inpatient hysteroscopy and curettage for the investigation of abnormal uterine bleeding ; 2 .
RESULTS	Hysteroscopy will detect some fibroids and polyps missed by a combination of transvaginal ultrasound and Pipelle endometrial sampling ; 3 .
RESULTS	The quality of histological samples obtained by outpatient Pipelle were comparable to those obtained by formal inpatient curettage ; and 4 .
RESULTS	Outpatient procedures were well tolerated , with good patient acceptability .
CONCLUSIONS	Transvaginal sonography and endometrial biopsy can safely be used as the initial investigations in the management of abnormal uterine bleeding .
CONCLUSIONS	Hysteroscopy can be used as a second line investigation .
CONCLUSIONS	Outpatient hysteroscopy with local anaesthesia is well tolerated although general anesthesia may occasionally be necessary .

###15122555
OBJECTIVE	A 2-arm , parallel-group , stratified-block , randomized clinical trial was designed to assess whether patients ' perceptions of recovery and satisfaction 4 to 6 weeks after surgery were affected by 3 factors : preparation strategy ( viewing a visual treatment simulation ) , attitudes ( expectations about recovery ) , and psychologic distress ( reported before surgery ) .
METHODS	One hundred eighty-four patients with a dentofacial disharmony scheduled for orthognathic surgery were randomly assigned to 1 of 2 preparation strategy groups : a standard presurgical consultation with or without a computerized treatment simulation presentation .
METHODS	Psychologic well-being and expectations regarding recovery were obtained before surgery and perceptions of recovery , and satisfaction were assessed for 126 patients at 4 to 6 weeks after surgery .
RESULTS	Viewing a treatment simulation before surgery did not affect patients ' perceptions of postsurgical discomfort or satisfaction at 4 to 6 weeks after surgery .
RESULTS	Patients who overestimated the discomfort or problems they would experience reported significantly lower average level of problems than those who did not overestimate .
RESULTS	Patients who were psychologically distressed before surgery reported , on average , significantly more discomfort or difficulty with symptoms , social/self-concerns , general health , and overall recovery after surgery .
CONCLUSIONS	Viewing a treatment simulation before surgery does not , on average , negatively affect perception of symptoms or satisfaction 4 to 6 weeks after surgery .
CONCLUSIONS	Orthognathic surgery patients who are psychologically distressed before surgery tend to report a higher recovery burden overall and , on average , experience more difficulty with symptoms , social/self-concerns , and general health in the first 1 or 2 months after surgery .

###7501332
OBJECTIVE	To compare two prostaglandin ( PG ) E2 preparations for pre-induction cervical ripening in a randomized clinical trial .
METHODS	Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women .
METHODS	Outcomes assessed were induction failure , need for labor augmentation , pain relief requirements , fetal heart rate ( FHR ) abnormalities , operative delivery rate , induction-to-delivery interval , neonatal condition , and occurrence of uterine hyperstimulation .
RESULTS	There was no statistical difference in pre - and post-dose cervical scores .
RESULTS	Compared with the tablet group , women in the gel group were more likely to have significant FHR abnormalities in early labor ( odds ratio [ OR ] 4.77 , 95 % confidence interval [ CI ] 1.15-19 .5 ) requiring cesarean delivery .
RESULTS	Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group ( chi 2 = 4.31 , P < .05 ) .
RESULTS	Compared with the gel group , women in the tablet group were significantly more likely to require operative delivery for poor progress in labor ( OR 2.83 , 95 % CI 1.20-7 .24 ) .
RESULTS	Other clinical outcomes were identical , with no significant differences in the overall rate of failed induction , cesarean delivery , rate of assisted delivery , requirement for oxytocin infusion , induction-to-delivery interval , pain relief requirements , or neonatal condition .
CONCLUSIONS	When compared with the PGE2 tablet , the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome .
CONCLUSIONS	Whereas the gel was associated with an increase in significant FHR abnormalities , the tablet was associated with an increase in the rate of operative delivery for poor progress in labor .

###10979796
BACKGROUND	Despite its association with disability , death , and increased medical costs , osteoporosis in men has been relatively neglected as a subject of study .
BACKGROUND	There have been no large , controlled trials of treatment in men .
METHODS	In a two-year double-blind trial , we studied the effect of 10 mg of alendronate or placebo , given daily , on bone mineral density in 241 men ( age , 31 to 87 years ; mean , 63 ) with osteoporosis .
METHODS	Approximately one third had low serum free testosterone concentrations at base line ; the rest had normal concentrations .
METHODS	Men with other secondary causes of osteoporosis were excluded .
METHODS	All the men received calcium and vitamin D supplements .
METHODS	The main outcome measures were the percent changes in lumbar-spine , hip , and total-body bone mineral density .
RESULTS	The men who received alendronate had a mean ( + / - SE ) increase in bone mineral density of 7.1 + / -0.3 percent at the lumbar spine , 2.5 + / -0.4 percent at the femoral neck , and 2.0 + / -0.2 percent for the total body ( P < 0.001 for all comparisons with base line ) .
RESULTS	In contrast , men who received placebo had an increase in lumbar-spine bone mineral density of 1.8 + / -0.5 percent ( P < 0.001 for the comparison with base line ) and no significant changes in femoral-neck or total-body bone mineral density .
RESULTS	The increase in bone mineral density in the alendronate group was greater than that in the placebo group at all measurement sites ( P < 0.001 ) .
RESULTS	The incidence of vertebral fractures was lower in the alendronate group than in the placebo group ( 0.8 percent vs. 7.1 percent , P = 0.02 ) .
RESULTS	Men in the placebo group had a 2.4-mm decrease in height , as compared with a decrease of 0.6 mm in the alendronate group ( P = 0.02 ) .
RESULTS	Alendronate was generally well tolerated .
CONCLUSIONS	In men with osteoporosis , alendronate significantly increases spine , hip , and total-body bone mineral density and helps prevent vertebral fractures and decreases in height .

###18218556
BACKGROUND	Previous studies on variable stiffness colonoscopes showed mixed results .
BACKGROUND	Different methods of activating the variable stiffness function were used and might explain part of the controversy .
BACKGROUND	To determine the most efficient way of activating the variable stiffness function , this study compared 3 methods ( no activation , regular activation , activation on an as-needed basis ) using 1 single type of pediatric variable stiffness colonoscope .
METHODS	Asymptomatic patients admitted for physical check-up at the Buddhist Dalin Tzu Chi General Hospital were included .
METHODS	A single endoscopist performed all of the colonoscopic examinations of patients under sedation using a variable stiffness pediatric colonoscope .
METHODS	Consecutive patients were randomized to undergo colonoscopy using 3 different methods of activating the variable stiffness function : no activation ( `` no '' group ) , regular activation at descending colon ( `` regular '' group ) , and activation on an as-needed basis ( `` as-needed '' group ) .
METHODS	Completion rate , cecal intubation time , and use of adjunct measures were evaluated and compared among the 3 groups .
METHODS	Subgroup analysis by gender was also performed .
RESULTS	Between January and July 2006 , a total of 250 patients were enrolled .
RESULTS	The completion rates of the examinations were 97.6 % , 91.7 % and 96.4 % in the no , regular and as-needed groups , respectively ( p = 0.17 ) .
RESULTS	The cecal intubation times were 5.6 + / - 2.6 minutes , 5.6 + / - 2.7 minutes and 6.2 + / - 2.3 minutes , respectively ( p = 0.22 ) .
RESULTS	Multivariate logistic regression analysis showed that activation of the variable stiffness function regularly ( odds ratio [ OR ] , 0.53 ; 95 % confidence interval [ CI ] , 0.28 , 0.98 ; p = 0.04 ) or on an as-needed basis ( OR , 0.52 ; 95 % CI , 0.28 , 0.97 ; p = 0.04 ) were independent factors that were related with less use of abdominal pressure .
RESULTS	When only women were considered , the completion rate was lower in the regular group ( 98.0 % , 86.8 % and 96.5 % , p = 0.04 ) .
RESULTS	The use of abdominal pressure was more in the no group than the other 2 groups ( 56 % , 34 % and 33 % , p = 0.03 ) .
RESULTS	When only men were considered , the cecal intubation time was longer in the as-needed group ( 4.6 + / - 1.4 , 4.6 + / - 1.8 and 5.8 + / - 2.5 minutes , p = 0.02 ) .
RESULTS	The other outcomes were similar in both genders .
CONCLUSIONS	The 3 different methods did not result in significantly different completion rates or cecal intubation times .
CONCLUSIONS	However , activation of the variable stiffness function decreased the need for abdominal pressure .
CONCLUSIONS	When males and females were considered separately , activation of the variable stiffness function on an as-needed basis in females was the only useful setting .

###22459892
BACKGROUND	Despite the high prevalence of clinical benign prostatic hyperplasia ( BPH ) among older men , there remains a notable absence of studies focused on BPH prevention .
OBJECTIVE	To determine if finasteride prevents incident clinical BPH in healthy older men .
METHODS	Data for this study are from the Prostate Cancer Prevention Trial .
METHODS	After excluding those with a history of BPH diagnosis or treatment , or an International Prostate Symptom Score ( IPSS ) 8 at study entry , 9253 men were available for analysis .
METHODS	The primary outcome was incident clinical BPH , defined as the initiation of medical treatment , surgery , or sustained , clinically significant urinary symptoms ( IPSS > 14 ) .
METHODS	Finasteride efficacy was estimated using Cox proportional regression models to generate hazards ratios ( HRs ) .
CONCLUSIONS	Mean length of follow-up was 5.3 yr .
CONCLUSIONS	The rate of clinical BPH was 19 per 1000 person-years in the placebo arm and 11 per 1000 person-years in the finasteride arm ( p < 0.001 ) .
CONCLUSIONS	In a covariate-adjusted model , finasteride reduced the risk of incident clinical BPH by 40 % ( HR : 0.60 ; 95 % confidence interval , 0.51-0 .69 ; p < 0.001 ) .
CONCLUSIONS	The effect of finasteride on incident clinical BPH was attenuated in men with a body mass index 30 kg/m ( 2 ) ( p ( interaction ) = 0.04 ) but otherwise did not differ significantly by physical activity , age , race , current diabetes , or current smoking .
CONCLUSIONS	The post hoc nature of the analysis is a potential study limitation .
CONCLUSIONS	Finasteride substantially reduces the risk of incident clinical BPH in healthy older men .
CONCLUSIONS	These results should be considered in formulating recommendations for the use of finasteride to prevent prostate diseases in asymptomatic older men .

###9431610
METHODS	A randomized clinical trial .
OBJECTIVE	To assess the efficacy of motorized continuous traction for low back pain .
BACKGROUND	The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe methodologic flaws .
BACKGROUND	The current trial aimed to overcome these shortcomings .
METHODS	Patients with at least 6 weeks of nonspecific low back pain were selected .
METHODS	High-dose traction was compared with sham ( or low-dose ) traction .
METHODS	Sham traction was given with a specially developed brace that becomes tighter in the back during traction .
METHODS	This was experienced as if real traction were exerted .
METHODS	The patients and the outcome assessor were unaware of treatment allocation .
METHODS	Outcome measures were : patient 's global perceived effect , severity of main complaints , functional status , pain , range of motion , work absence , and medical treatment .
METHODS	Results for the outcome measures at 12 weeks and 6 months after randomization are presented .
RESULTS	One hundred and fifty-one patients were randomly allocated to one of the two treatment methods .
RESULTS	Intention-to-treat analysis of the 12-week and 6-month results showed no statistically significant differences between the groups on all outcome measures : all 95 % confidence intervals included the value zero .
RESULTS	The number of patients lost to follow-up study was very low .
RESULTS	Other analyses showed the same results .
CONCLUSIONS	Most common flaws of earlier studies on traction therapy could be overcome .
CONCLUSIONS	This trial did not support the claim that traction is efficacious for patients with low back pain .

###22041501
BACKGROUND	It has been reported that both sublingual ( SLIT ) and subcutaneous ( SCIT ) allergen-specific immunotherapy have clinical efficacy , yet there are rather few comparative placebo studies of children .
BACKGROUND	We aimed to investigate the clinical and immunological efficacy of mite-specific SLIT and SCIT versus a placebo in rhinitis and asthma in children .
METHODS	The outcomes of this 1-year , randomized , placebo-controlled , double-blind , double-dummy study were symptom and medication scores , visual analog scores ( VAS ) , titrated skin prick tests , nasal and bronchial allergen provocation doses , serum house dust mite-specific immunglobulin E ( HDM-sIgE ) , sIgG4 , IL-10 and IFN - levels .
RESULTS	Clinical and laboratory parameters were evaluated in 30 patients .
RESULTS	SCIT significantly diminished symptom and medication scores for rhinitis and asthma ( p = 0.03 and p = 0.05 for rhinitis ; p = 0.01 and p = 0.05 for asthma ) and VAS .
RESULTS	SLIT also reduced VAS , symptoms associated with rhinitis and asthma as well as medication usage for rhinitis , but this reduction was not significant when compared with the placebo .
RESULTS	Skin reactivitiy to HDM and HDM-sIgE levels was reduced significantly in both immunotherapy groups .
RESULTS	Serum IL-10 levels and nasal provocative doses increased significantly with both SCIT and SLIT .
RESULTS	Nasal eosinophil increments after nasal challenge decreased with two treatment modes , but bronchial provocative doses and sputum eosinophil increments after bronchial challenge were reduced only with SCIT .
RESULTS	In both treatment arms , there was no change in IFN - levels .
RESULTS	Serum sIgG4 levels increased significantly only in the SCIT group .
CONCLUSIONS	Based on the limited number of patients at the end of the 1-year immunotherapy , the clinical efficacy of SCIT on rhinitis and asthma symptoms was more evident when compared with the placebo .

###24105358
OBJECTIVE	This is a pilot study investigating the effect of healing touch ( HT ) on fatigue in breast cancer patients undergoing radiation therapy ( RT ) .
METHODS	This study presents the results of a within-subjects design randomized clinical trial where the treatment group was treated with HT , whereas the control group experienced sham therapy .
METHODS	The setting was a university RT clinic .
METHODS	The participants were breast cancer patients treated with lumpectomy or mastectomy , 21 to 75 years old with an Eastern Cooperative Oncology Group ( ECOG ) score of 0 to 2 .
METHODS	The intervention was a 45-minute session of HT or sham therapy once a week during RT. .
METHODS	Outcome measures included fatigue , quality of life ( QOL ) , and anxiety/depression .
RESULTS	A total of 70 patients were approached , with 41 completing the study .
RESULTS	At completion , the HT participants tended to report higher levels of fatigue , statistically significant for interference ( : = .010 ) and usual fatigue ( : = .024 ) .
RESULTS	The control group tended to report greater reductions in fatigue relative to their own means than the HT group ( Cohen 's : = 0.30 to 0.49 vs 0.06 to 0.18 , respectively ) .
RESULTS	There were no statistically significant differences between the groups for QOL .
CONCLUSIONS	Our enrollment and retention indicate that HT is feasible for women during RT. .
CONCLUSIONS	Our pilot findings do not support a beneficial effect of HT on fatigue or QOL .
CONCLUSIONS	Future research may explore increasing dose and teasing out therapist effect .

###12387962
BACKGROUND	Chlorproguanil-dapsone exerts lower resistance pressure on Plasmodium falciparum than does sulfadoxine-pyrimethamine , but is rapidly eliminated .
BACKGROUND	We aimed to find out whether chlorproguanil-dapsone results in a higher retreatment rate for malaria than sulfadoxine-pyrimethamine .
METHODS	In a randomised trial of paediatric outpatients with uncomplicated falciparum malaria , patients received either chlorproguanil-dapsone or sulfadoxine-pyrimethamine and were followed up for up to 1 year .
METHODS	Sites were in Kenya ( n = 410 ) and Malawi ( n = 500 ) .
METHODS	We used per-protocol analysis to assess the primary outcome of annual malaria incidence .
RESULTS	Drop-outs were 117 of 410 ( 28.5 % ) in Kenya , and 342 of 500 ( 68.4 % ) in Malawi .
RESULTS	Follow-up was for a median of 338 days ( IQR 128-360 ) and 342 days ( 152-359 ) in Kilifi ( chlorproguanil-dapsone and sulfadoxine-pyrimethamine , respectively ) , and for 120 days ( 33-281 ) and 84 days ( 26-224 ) in Blantyre .
RESULTS	Mean annual malaria incidence was 2.5 versus 2.1 in Kenya ( relative risk 1.16 , 95 % CI 0.98-1 .37 ) , and 2.2 versus 2.8 in Malawi ( 0.77 , 0.63-0 .94 ) .
RESULTS	4.3 % versus 12.8 % , and 5.4 % versus 20.1 % , of patients were withdrawn for treatment failure in Kenya and Malawi , respectively .
RESULTS	In Kenya haemoglobin concentration of 50 g/L or less caused exit in 6.9 % of chlorproguanil-dapsone patients and 1.5 % of sulfadoxine-pyrimethamine patients , but most anaemia occurred before re-treatment .
RESULTS	In Malawi only one patient exited because of anaemia .
CONCLUSIONS	Despite the rapid elimination of chlorproguanil-dapsone , children treated with this drug did not have a higher incidence of malaria episodes than those treated with sulfadoxine-pyrimethamine .
CONCLUSIONS	Treatment failure was more common with sulfadoxine-pyrimethamine .
CONCLUSIONS	Cause of anaemia in Kenya was probably not adverse reaction to chlorproguanil-dapsone , but this observation requires further study .

###20451345
OBJECTIVE	the modern joint protection ( JP ) concept for people with rheumatoid arthritis ( RA ) is an active coping strategy to improve daily tasks and role performance by changing working methods and using assistive devices .
OBJECTIVE	Effective group JP education includes psycho-educational interventions .
OBJECTIVE	The Pictorial Representation of Illness and Self Measure ( PRISM ) is an interactive hands-on-tool , assessing ( a ) the individual 's perceived burden of illness and ( b ) relevant individual resources .
OBJECTIVE	Both issues are important for intrinsic motivation to take action and change behaviour .
OBJECTIVE	This study compared individual conventional JP education ( C-JP ) with PRISM-based JP education ( PRISM-JP ) .
METHODS	an assessor-blinded multicentre randomized controlled trial , including four JP education sessions over 3 weeks , with assessments at baseline and 3 months .
RESULTS	in total 53 RA patients participated .
RESULTS	At 3 months , the PRISM-JP ( n = 26 ) participants did significantly better compared to the C-JP participants ( n = 27 ) in JP behaviour ( p = 0.02 and p = 0.008 when corrected for baseline values ) , Arthritis Self-efficacy ( ASES , p = 0.015 ) and JP self-efficacy ( JP-SES , p = 0.047 ) .
RESULTS	Within-group analysis also showed less hand pain ( p < 0.001 ) in PRISM-JP group .
CONCLUSIONS	PRISM-JP more effectively supported learning of JP methods , with meaningful occupations , resource activation and self-efficacy acting as important mediators .
CONCLUSIONS	PRISM improved patient-clinician communication and is feasible for occupational therapy .

###24102148
OBJECTIVE	The objective of this study was to evaluate the effect of an intervention with advance provision of emergency contraceptive pills ( ECP ) , condoms , and extended information to a targeted group of teenage girls , compared with a control group , 12 months after intervention .
METHODS	A randomized controlled trial among 420 girls , 15-19 years old , requesting emergency contraception at a youth clinic in Sweden was carried out .
METHODS	Data were collected by a questionnaire at the initial visit and structured telephone interviews 12 months after enrolment .
METHODS	Differences between the intervention group and the control group regarding ECP use , time interval from unprotected intercourse to ECP intake , contraceptive use , and sexual risk-taking were analysed .
RESULTS	One year after the intervention 62 % of the girls could be reached for follow-up .
RESULTS	The girls in the intervention group reported a shorter time interval ( mean 15.3 hours ) from unprotected intercourse to ECP intake compared to the control group ( mean 25.8 hours ) ( p = 0.019 ) , without any evidence of decreased use of contraceptives or increased sexual risk-taking .
CONCLUSIONS	Even up to 12 months following the intervention , advance provision of ECP at one single occasion , to a specific target group of adolescent girls , shortens the time interval from unprotected intercourse to pill intake , without jeopardizing contraceptive use or increasing sexual risk-taking .
CONCLUSIONS	Considering the clinical relevance of these results , we suggest that advance provision of ECP could be implemented as a routine preventive measure for this target group .

###21639607
OBJECTIVE	To examine the dependability of alliance scores at the patient and therapist level , to evaluate the potential causal direction of session-to-session changes in alliance and depressive symptoms , and to investigate the impact of aggregating the alliance over progressively more sessions on the size of the alliance-outcome relationship .
METHODS	We used data from a study ( N = 45 patients ; N = 9 therapists ) of psychotherapy for major depressive disorder in which the alliance was measured at every treatment session to calculate generalizability coefficients and to predict change in depressive symptoms from alliance scores .
METHODS	Two replication samples were also used .
RESULTS	At the therapist level , a large number of patients ( about 60 ) per therapist is needed to provide a dependable therapist-level alliance score .
RESULTS	At the patient level , generalizability coefficients revealed that a single assessment of the alliance is only marginally acceptable .
RESULTS	Very good ( > .90 ) dependability at the patient level is only achieved through aggregating 4 or more assessments of the alliance .
RESULTS	Session-to-session change in the alliance predicted subsequent session-to-session changes in symptoms .
RESULTS	Evidence for reverse causation was found in later-in-treatment sessions , suggesting that only aggregates of early treatment alliance scores should be used to predict outcome .
RESULTS	Session 3 alliance scores explained 4.7 % of outcome variance , but the average of Sessions 3-9 explained 14.7 % of outcome variance .
CONCLUSIONS	Adequate assessment of the alliance using multiple patients per therapist and at least 4 treatment sessions is crucial for fully understanding the size of the alliance-outcome relationship .

###17984136
OBJECTIVE	The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown .
OBJECTIVE	We hypothesized that MVS combined with LA cryoablation is superior to MVS alone .
RESULTS	Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation .
RESULTS	The primary endpoint was regained sinus rhythm .
RESULTS	Risk factors for failed AF cryoablation were elucidated .
RESULTS	Sixty-five out of 69 patients reached the primary endpoint .
RESULTS	At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) .
RESULTS	The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) .
RESULTS	Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis .
CONCLUSIONS	This first prospective randomized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone .

###19142539
OBJECTIVE	to compare diagnostic hysteroscopy through vaginoscopy , using warm saline solution , with traditional technique , regarding to pain , patient satisfaction and feasibility of the procedure .
METHODS	randomized clinical trial , involving 184 women , referred for diagnostic hysteroscopy , between May and December of 2006 .
METHODS	Participants were randomized to be submitted to hysteroscopy by the proposed technique , which consisted of access through vaginoscopy using normal saline at 36 degrees C as distension medium , no speculum or cervical grasping , or by the traditional technique with CO2 .
METHODS	In both techniques , a 2.7 mm hysteroscope was used .
METHODS	Pain was assessed by the analogical visual scale , during the procedure and every five minutes after it .
RESULTS	the mean pain score was 1.60 in the proposed technique and 3.39 in the traditional technique ( p < 0.01 ) .
RESULTS	Lower pain scores were also observed after 5 , 10 and 15 minutes ( p < 0,01 ) as well as after 20 minutes ( p = 0.056 ) .
RESULTS	In the proposed technique , 82.4 % of the procedures were feasible , while , in the traditional technique , 84.9 % were so ( p = 0.64 ) .
RESULTS	Satisfaction with the procedure was referred by 88.7 % of women submitted to the proposed technique and by 76.3 % of women submitted to the traditional technique ( p < 0.05 ) .
CONCLUSIONS	diagnostic hysteroscopy by the proposed technique resulted in less pain , same feasibility and greater satisfaction of patients .

###17313001
OBJECTIVE	To probe clinical therapeutic effect of acupuncture on diabetic retinopathy and the mechanism .
METHODS	One hundred and twenty cases of diabetic retinopathy were randomly divided into an observed group and a control group , 60 cases in each group .
METHODS	On the basis of routine diabetic treatment , the observation group were treated with the acupoints for regulating the spleen and stomach , and the control group with the acupoints around eye mainly .
METHODS	Clinical therapeutic effect was evaluated by eye fundus condition , blood glucose , blood lipids , nitric oxide ( NO ) and endothelin ( ET ) levels .
RESULTS	The needling method for regulating the spleen and stomach not only can improve the eye fundus condition , but also has benign regulative action on metabolism of blood glucose and blood lipids , and NO and ET levels , with significant differences as compared with those in the control group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	The needling method for regulating the spleen and stomach is an effective therapy for diabetic retinopathy , and the mechanism is possibly related with the regulation of levels of vascular active substances , NO and ET .

###18799425
OBJECTIVE	To assess the relationship between depression and anxiety comorbidity on pain intensity , pain-related disability , and health-related quality of life ( HRQL ) .
METHODS	Analysis of baseline data from the Stepped Care for Affective Disorders and Musculoskeletal Pain ( SCAMP ) study .
METHODS	All patients ( n = 500 ) had chronic pain ( > or = 3-month duration ) of the low back , hip , or knee .
METHODS	Patients with depression were oversampled for the clinical trial component of SCAMP and thus represented 50 % of the study population .
METHODS	Patients were categorized according to pain comorbid with depression , anxiety , or both .
METHODS	We used analysis of variance and multivariate analysis of variance models to assess the relationships between independent and dependent variables .
RESULTS	Participants had a mean age of 59 years ; they were 55 % women , 56 % White , and 40 % Black .
RESULTS	Fifty-four percent ( n = 271 ) reported pain only , 20 % ( n = 98 ) had pain and depression , 3 % ( n = 15 ) had pain and anxiety , and 23 % ( n = 116 ) had pain , depression , and anxiety .
RESULTS	Patients with pain and both depression and anxiety experienced the greatest pain severity ( p < .0001 ) and pain-related disability ( p < .0001 ) .
RESULTS	Psychiatric comorbidity was strongly associated with disability days in the past 3 months ( p < .0001 ) , with 18.1 days reported by patients with pain only , 32.2 days by those with pain and anxiety , 38.0 days by those with pain and depression , and 42.6 days in those with all three conditions .
RESULTS	We found a similar pattern of poorer HRQL ( p < .0001 ) in those with pain , depression , and anxiety .
CONCLUSIONS	The added morbidity of depression and anxiety with chronic pain is strongly associated with more severe pain , greater disability , and poorer HRQL .

###11137414
OBJECTIVE	To assess the analgesic efficacy and perioperative opioid-sparing effects of adjuvant intravenous ( IV ) diclofenac .
METHODS	Prospective , controlled , double-blind study .
METHODS	Large referral hospital .
METHODS	40 ASA physical status I , II , and III geriatric patients ( > 65 years ) undergoing open reduction and internal fixation of subcapital fracture of the femur .
METHODS	A standardized general anesthetic was administered .
METHODS	On induction of anesthesia , patients in the diclofenac group received an IV bolus of diclofenac ( 0.7 mg/kg ) followed by a constant infusion ( 0.15 mg/kg/hr ) until the end of surgery .
METHODS	In the saline group , an equal volume of saline was administered .
METHODS	`` Rescue '' fentanyl was administered in response to an increase in mean arterial pressure or heart rate ( exceeding 20 % of the patient 's preinduction `` baseline '' values ) that did not respond to a 30 % increase in the inspired isoflurane concentration .
METHODS	Postoperative pain was assessed using a four-point patient-generated pain score ( 1 = none , 2 = mild , 3 = moderate , 4 = severe ) as well as number of attempts and actual morphine delivered via a patient-controlled analgesia ( PCA ) device .
RESULTS	The two treatment groups were demographically comparable .
RESULTS	The perioperative hemodynamic variables , as well as the induction and `` rescue '' fentanyl dosages , were unaffected by the treatment modality .
RESULTS	Pain scores , PCA attempts , and actual morphine delivered were statistically similar between the two groups .
CONCLUSIONS	Adjuvant IV diclofenac does not improve intraoperative stability or decrease postoperative opioid requirements in geriatric patients undergoing internal fixation of subcapital fracture of the femur .

###12560306
OBJECTIVE	Peripheral opioid receptors may result in antinociceptive effects when occupied by opioids .
OBJECTIVE	This study examined intradermally injected sufentanil ( S ) , a highly lipid soluble opioid , administered with and without lidocaine ( L ) , in a thermal pain model .
METHODS	Nine volunteers were instructed on the method of magnitude estimation of pain before undergoing baseline testing with seven seconds thermal stimuli between 44 and 52 degrees C , delivered by a contact thermal stimulator at five cutaneous forearm sites .
METHODS	Then , four sites randomly received injections of equal volumes ( 0.1 mL ) of either normal saline ( NS ) , lidocaine 0.5 % ( L ) , sufentanil 0.75 microg ( S ) , lidocaine 0.5 % plus sufentanil 0.75 microg ( L+S ) , and one site was not injected and served as reference ( REF ) .
METHODS	Testing was repeated at six , 30 , 60 , 90 , 120 , and 150 min following injection .
METHODS	The pain elicited by each stimulus was normalized to the subject 's response to the 50 degrees C stimulus at the REF site .
RESULTS	Baseline testing showed small ( P = ns ) differences in pain scores .
RESULTS	At six minutes , the lidocaine sites ( L , L+S ) had pain scores that were mean 83 % ( range 78-88 % ) lower than the other sites ( P < 0.05 ) , but there was no difference between the L and L+S sites or between the S and NS or REF sites .
RESULTS	At 30 and 60 min these pain scores were mean 38 % ( 29-44 % ) and 20 % ( 8-30 % ) less than at the REF , NS , and S sites ( P = ns ) .
RESULTS	At 90 min and later times , the pain scores had returned to baseline .
CONCLUSIONS	These results suggest that intradermal sufentanil alone has no analgesic effect .
CONCLUSIONS	Further , in combination with lidocaine , sufentanil does neither potentiate nor prolong the analgesic effect of lidocaine .

###24272788
OBJECTIVE	The objective was to explore the role of specific patient-related and operator-related factors in pain perception during flexible laryngoscopy , which is one of the most common ENT procedures .
METHODS	Monocentric , randomized , individual prospective study .
METHODS	A total of 532 patients ( 145 men and 387 women ) , without any relevant ENT diseases , underwent laryngoscopy performed by otolaryngologists with various degrees of experience .
METHODS	Patient discomfort was reported using visual analog scores , and willingness to repeat the experience was also recorded .
RESULTS	Statistical analysis showed that greater pain was significantly associated with female patients and female otolaryngologists , whereas the pain was less severe in the cases of experienced laryngologists and older patients .
RESULTS	Pain plays an important role in determining the willingness to repeat the examination ; in fact , patients who experienced lower levels of pain during laryngoscopy were more prone to repeat the experience .
CONCLUSIONS	This article explores the importance of the extrinsic factors that are related to the patient and the otolaryngologist in determining the level of pain associated with laryngoscopy .
CONCLUSIONS	Our study indicated that laryngoscopy is generally a well-tolerated procedure , causing little overall discomfort , but that a subgroup of patients may experience more pain than others , which may affect the patient 's perspective toward undergoing a similar future experience .
CONCLUSIONS	Our analysis may be helpful for clinicians in understanding pain perception during a routine procedure , enabling them to focus more on that subgroup of patients who are more prone to pain .
METHODS	1b .

###15179345
OBJECTIVE	The cardioprotective effects afforded by volatile anesthetics , i.e. isoflurane , during heart surgery may be due to preconditioning of the myocardium through the activation of KATP channels .
OBJECTIVE	The aims of this study were to establish whether glibenclamide prevents the isoflurane-induced cardioprotection in diabetic patients undergoing coronary surgery ( CABG ) and whether this cardioprotective effect can be restored by preoperative shift from glibenclamide to insulin therapy .
METHODS	We enrolled 60 patients undergoing CABG .
METHODS	Twenty consecutive non-diabetic patients were randomized to receive conventional anesthesia ( CA ) or conventional anesthesia plus isoflurane ( ISO ) ( added to the inspired oxygen before starting cardiopulmonary bypass ) ; 40 consecutive diabetic patients in chronic treatment with oral glibenclamide were randomized to conventional anesthesia ( G-CA ) , conventional anesthesia plus isoflurane ( G-ISO ) , conventional anesthesia after shifting to insulin ( I-CA ) or conventional anesthesia plus isoflurane after shifting to insulin ( I-ISO ) .
METHODS	Serum levels of cardiac troponin I ( CTnI ) and CK-MB , as markers of ischemic injury , were obtained 1 , 24 , 48 and 96 hours , postoperatively .
RESULTS	Postoperative peak levels of CTnI and CK-MB were lower in ISO than in CA ( 0.5 + / -0.3 vs 2.8 + / -2.2 ng/ml , p < 0.05 and 61 + / -27 vs 79 + / -28 U/L , p < 0.05 , respectively ) , as well as in I-CA and I-ISO than G-CA and G-ISO groups ( 0.5 + / -0.7 and 0.7 + / -0.9 vs 3.5 + / -3 and 2.7 + / -2.5 ng/ml , p < 0.05 ; 47 + / -7 and 41 + / -5 vs 85 + / -28 and 50 + / -23 U/L , p < 0.05 , respectively ) .
RESULTS	No significant differences were detected in postoperative hemodynamic variables or in-hospital outcome .
CONCLUSIONS	This prospective randomized study shows a cardioprotective effect of preoperative administration of isoflurane during CABG .
CONCLUSIONS	Such an effect is prevented by glibenclamide , but can be restored in diabetic patients by preoperative shift from glibenclamide to insulin .

###21784297
OBJECTIVE	To evaluate the clinical and prognostic significance of suicide attempts ( SAs ) and nonsuicidal self-injury ( NSSI ) in adolescents with treatment-resistant depression .
METHODS	Depressed adolescents who did not improve with an adequate SSRI trial ( N = 334 ) were randomized to a medication switch ( SSRI or venlafaxine ) , with or without cognitive-behavioral therapy .
METHODS	NSSI and SAs were assessed at baseline and throughout the 24-week treatment period .
RESULTS	Of the youths , 47.4 % reported a history of self-injurious behavior at baseline : 23.9 % NSSI alone , 14 % NSSI+SA s , and 9.5 % SAs alone .
RESULTS	The 24-week incidence rates of SAs and NSSI were 7 % and 11 % , respectively ; these rates were highest among youths with NSSI+SA s at baseline .
RESULTS	NSSI history predicted both incident SAs ( hazard ratio [ HR ] = 5.28 , 95 % confidence interval [ CI ] = 1.80-15 .47 , z = 3.04 , p = .002 ) and incident NSSI ( HR = 7.31 , z = 4.19 , 95 % CI = 2.88-18 .54 , p < .001 ) through week 24 , and was a stronger predictor of future attempts than a history of SAs ( HR = 1.92 , 95 % CI = 0.81-4 .52 , z = 2.29 , p = .13 ) .
RESULTS	In the most parsimonious model predicting time to incident SAs , baseline NSSI history and hopelessness were significant predictors , adjusting for treatment effects .
RESULTS	Parallel analyses predicting time to incident NSSI through week 24 identified baseline NSSI history and physical and/or sexual abuse history as significant predictors .
CONCLUSIONS	NSSI is a common problem among youths with treatment-resistant depression and is a significant predictor of future SAs and NSSI , underscoring the critical need for strategies that target the prevention of both NSSI and suicidal behavior .
BACKGROUND	Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique Identifier : NCT00018902 .

###18760135
BACKGROUND	Atrial fibrillation ( AF ) is associated with increased morbidity and mortality in patients suffering from heart failure ( HF ) .
BACKGROUND	Patients in New York Heart Association HF classes III or IV , with systolic dysfunction and a wide QRS , are candidates for cardiac resynchronization therapy ( CRT ) , and might benefit from atrial overdrive pacing ( AOP ) .
METHODS	The Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy ( MASCOT ) trial enrolled 409 CRT device recipients ( 79 % men ) , who were randomly assigned to AOP ON ( n = 197 ) , versus AOP OFF ( n = 197 ) and followed up for 1 year .
METHODS	Their mean age was 68 + / - 10 years , left ventricular ejection fraction 25 + / - 6 % , QRS duration 163 + / - 29 milliseconds .
METHODS	New York Heart Association class III was present in 86 % of patients and 19 % had a history of paroxysmal AF .
METHODS	The primary study end point was incidence of permanent AF at 1 year .
RESULTS	Atrial overdrive pacing increased the percentage of atrial pacing from 30 % to 80 % ( P < .0001 ) , was well tolerated , and did not interfere with ( a ) delivery of CRT ( 95 % mean ventricular pacing in both groups ) , ( b ) response to CRT ( 70 % responders in the control vs 67 % in the treatment group ) , or ( c ) cardiac function ( left ventricular ejection fraction increased from 24.5 % + / - 6.2 % to 32.7 % + / - 10.9 % in the control and from 25.8 % + / - 6.8 % to 33.1 % + / - 12.6 % in the treatment group ) .
RESULTS	The incidence of permanent AF was 3.3 % in both groups .
RESULTS	By logistic regression analysis , a history of AF ( P < .001 ) and absence of antiarrhythmic drugs ( P = .002 ) were associated with permanent AF .
CONCLUSIONS	In this first trial of a specific AF prevention algorithm in CRT recipients , AOP was safe and did not worsen HF .
CONCLUSIONS	The prevention algorithm did not lower the 1-year incidence of AF .

###17369514
BACKGROUND	A major challenge in stroke rehabilitation is restoration of arm motor function .
BACKGROUND	Therapy-induced improvements in arm function may occur via restoration of premorbid movement patterns ( recovery ) or development of compensatory movement strategies .
BACKGROUND	However , it is unclear whether the learning benefits of practice might be enhanced by incorporating different forms of feedback , focusing on movement outcomes or on specific arm movement patterns .
OBJECTIVE	To determine if manipulation of attentional focus by providing either knowledge of results ( KR ) feedback , focusing on movement outcomes , or knowledge of performance ( KP ) feedback , focusing on arm movement patterns during repetitive practice of a pointing movement , may lead to arm motor recovery .
METHODS	Twenty-eight chronic stroke survivors were randomly assigned to 2 groups that practiced 10 sessions of 75 pointing movements .
METHODS	During practice , groups received either 20 % KR about movement precision or faded ( 26.6 % average ) KP about arm joint movements .
METHODS	A nondisabled control group ( n = 5 ) practiced the same task with KR .
RESULTS	Motor patterns recovered only in KP , as evidenced by immediate and long-term increases in joint range , better interjoint coordination in early movement phases , and generalization of gains .
RESULTS	Improvements in clinical impairment and function were related to decreases in compensation ( trunk rotation ) and recovery of interjoint coordination in mid-movement phases .
CONCLUSIONS	In stroke survivors , when the learners ' attention was directed to the movements themselves ( KP ) , motor improvements reflect recovery compared to when attention was directed toward movement outcomes ( KR ) .

###23269596
OBJECTIVE	To evaluate the efficacy and safety of minocycline in the management of HIV-associated cognitive impairment .
METHODS	We enrolled HIV-positive participants with a CD4 count of 250 to 500 cells/L in a randomized , double-blind , placebo-controlled study .
METHODS	They received 100 mg of minocycline or matching placebo orally every 12 hours for 24 weeks .
METHODS	Cognitive function was measured using the Uganda neuropsychological test battery summary measure ( U NP Sum ) and the Memorial Sloan-Kettering ( MSK ) scale .
METHODS	The primary efficacy measure was the 24-week change in an average of 9 standardized U NP Sum z scores .
RESULTS	Seventy-three participants were enrolled .
RESULTS	Of these , 90 % were female , 49 % were between the ages 30 and 39 years , and 74 % had 6 or more years of education .
RESULTS	One participant had MSK score of stage 1 ( i.e. , mild HIV dementia ) , and 72 participants had MSK stage 0.5 ( i.e. , equivocal or subclinical dementia ) at the baseline evaluation .
RESULTS	The minocycline effect on the 24-week change of the U NP Sum compared with placebo was 0.03 ( 95 % confidence interval -0.51 , 0.46 ; p = 0.37 ) .
CONCLUSIONS	Minocycline was safe and well tolerated in HIV-positive individuals .
CONCLUSIONS	However , it did not improve HIV-associated cognitive impairment .
METHODS	This study provides Class II evidence that 100 mg of minocycline given orally every 12 hours for 24 weeks had no significant effect compared with placebo in the improvement of cognitive function in antiretroviral therapy-naive , HIV-positive patients .

###10379018
BACKGROUND	Although patients with chronic obstructive pulmonary disease ( COPD ) should stop smoking , some do not .
BACKGROUND	In a double-blind , placebo-controlled study , we evaluated the effect of the inhaled glucocorticoid budesonide in patients with mild COPD who continued smoking .
BACKGROUND	After a six-month run-in period , we randomly assigned 1277 subjects ( mean age , 52 years ; mean forced expiratory volume in one second [ FEV1 ] , 77 percent of the predicted value ; 73 percent men ) to twice-daily treatment with 400 microg of budesonide or placebo , inhaled from a dry-powder inhaler , for three years .
RESULTS	Of the 1277 subjects , 912 ( 71 percent ) completed the study .
RESULTS	Among these subjects , the median decline in the FEV1 after the use of a bronchodilator over the three-year period was 140 ml in the budesonide group and 180 ml in the placebo group ( P = 0.05 ) , or 4.3 percent and 5.3 percent of the predicted value , respectively .
RESULTS	During the first six months of the study , the FEV1 improved at the rate of 17 ml per year in the budesonide group , as compared with a decline of 81 ml per year in the placebo group ( P < 0.001 ) .
RESULTS	From nine months to the end of treatment , the FEV1 declined at similar rates in the two groups ( P = 0.39 ) .
RESULTS	Ten percent of the subjects in the budesonide group and 4 percent of those in the placebo group had skin bruising ( P < 0.001 ) .
RESULTS	Newly diagnosed hypertension , bone fractures , postcapsular cataracts , myopathy , and diabetes occurred in less than 5 percent of the subjects , and the diagnoses were equally distributed between the groups .
CONCLUSIONS	In patients with mild COPD who continue smoking , the use of inhaled budesonide is associated with a small one-time improvement in lung function but does not appreciably affect the long-term progressive decline .

###18362594
BACKGROUND	Postoperative patients are sleep deprived .
BACKGROUND	Opioids , commonly administered for postoperative pain control , are often mistakenly considered inducers of naturally occurring sleep .
BACKGROUND	This study describes the effect of the opioid remifentanil on nocturnal sleep in healthy volunteers .
BACKGROUND	In addition , this study tests the hypothesis that opioid-induced sleep disturbance is caused by a circadian pacemaker disturbance , reflected by suppressed nocturnal plasma concentration of melatonin .
METHODS	Polysomnography was performed in 10 volunteers from 11:00 pm to 7:00 am for four nights at 6-day intervals .
METHODS	On two nights , remifentanil ( 0.01-0 .04 microg x kg x min ) was infused from 10:30 pm to 7:00 am , and either a placebo capsule or 3.0 mg melatonin was administered at 10:30 pm .
METHODS	On two additional nights , saline was infused , and the placebo or melatonin capsules were administered at 10:30 pm .
METHODS	Blood was drawn at 12:00 am , 3:00 am , and 6:00 am to measure the plasma concentration of melatonin and cortisol .
METHODS	A repeated-measures analysis of variance model was used to determine the effect of remifentanil on sleep stages , the effect of remifentanil on the plasma concentration of melatonin , and the effect of exogenous melatonin on remifentanil-induced sleep disturbance .
RESULTS	Remifentanil inhibited rapid eye movement sleep ( 14.1 + / - 7.2 % to 3.9 + / - 6.9 % ) .
RESULTS	The amount of slow wave sleep decreased from 6.8 + / - 7.6 % to 3.2 + / - 6.1 % , but this decrease was not statistically significant .
RESULTS	Remifentanil did not decrease melatonin concentration .
RESULTS	Melatonin administration did not prevent remifentanil-induced sleep disturbance .
CONCLUSIONS	An overnight constant infusion of remifentanil inhibits rapid eye movement sleep without suppressing the nocturnal melatonin surge .

###24504761
OBJECTIVE	The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) .
OBJECTIVE	While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies .
OBJECTIVE	We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies .
METHODS	Data were integrated from four randomized , placebo-controlled , double-blind , 12-week registrational studies of tadalafil for LUTS/BPH .
METHODS	Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) .
METHODS	Efficacy results were analyzed using analysis of covariance .
RESULTS	For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 1.2 .
RESULTS	The mean treatment change was -0.4 with placebo and -0.5 with tadalafil ; the least-squares mean ( standard error ) treatment difference was -0.2 ( 0.05 ) , p = 0.002 .
RESULTS	For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % .
CONCLUSIONS	A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinically meaningful .
CONCLUSIONS	Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH .

###18179503
OBJECTIVE	To evaluate hospital readmission rates and mortality at 6-month follow-up in selected elderly patients with acute exacerbation of chronic obstructive pulmonary disease ( COPD ) .
METHODS	Prospective randomized , controlled , single-blind trial with 6-month follow-up .
METHODS	San Giovanni Battista Hospital of Torino .
METHODS	One hundred four elderly patients admitted to the hospital for acute exacerbation of COPD were randomly assigned to a general medical ward ( GMW , n = 52 ) or to a geriatric home hospitalization service ( GHHS , n = 52 ) .
METHODS	Measurements of baseline sociodemographic information ; clinical data ; functional , cognitive , and nutritional status ; depression ; and quality of life were obtained .
RESULTS	There was a lower incidence of hospital readmissions for GHHS patients than for GMW patients at 6-month follow-up ( 42 % vs 87 % , P < .001 ) .
RESULTS	Cumulative mortality at 6 months was 20.2 % in the total sample , without significant differences between the two study groups .
RESULTS	Patients managed in the GHHS had a longer mean length of stay than those cared for in the GMW ( 15.5 + / -9.5 vs 11.0 + / -7.9 days , P = .010 ) .
RESULTS	Only GHHS patients experienced improvements in depression and quality-of-life scores .
RESULTS	On a cost per patient per day basis , GHHS costs were lower than costs in GMW ( $ 101.4 + / -61.3 vs $ 151.7 + / -96.4 , P = .002 ) .
CONCLUSIONS	Physician-led substitutive hospital-at-home care as an alternative to inpatient care for elderly patients with acute exacerbations of COPD is associated with a substantial reduction in the risk of hospital readmission at 6 months , lower healthcare costs , and better quality of life .

###15994720
OBJECTIVE	Risperidone is effective for short-term treatment of aggression , temper outbursts , and self-injurious behavior in children with autism .
OBJECTIVE	Because these behaviors may be chronic , there is a need to establish the efficacy and safety of longer-term treatment with this agent .
METHODS	The authors conducted a multisite , two-part study of risperidone in children ages 5 to 17 years with autism accompanied by severe tantrums , aggression , and/or self-injurious behavior who showed a positive response in an earlier 8-week trial .
METHODS	Part I consisted of 4-month open-label treatment with risperidone , starting at the established optimal dose ; part II was an 8-week randomized , double-blind , placebo-substitution study of risperidone withdrawal .
METHODS	Primary outcome measures were the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression improvement scale .
RESULTS	Part I included 63 children .
RESULTS	The mean risperidone dose was 1.96 mg/day at entry and remained stable over 16 weeks of open treatment .
RESULTS	The change on the Aberrant Behavior Checklist irritability subscale was small and clinically insignificant .
RESULTS	Reasons for discontinuation of part I included loss of efficacy ( N = 5 ) and adverse effects ( N = 1 ) .
RESULTS	The subjects gained an average of 5.1 kg .
RESULTS	Part II included 32 patients .
RESULTS	The relapse rates were 62.5 % for gradual placebo substitution and 12.5 % for continued risperidone ; this difference was statistically significant .
CONCLUSIONS	Risperidone showed persistent efficacy and good tolerability for intermediate-length treatment of children with autism characterized by tantrums , aggression , and/or self-injurious behavior .
CONCLUSIONS	Discontinuation after 6 months was associated with a rapid return of disruptive and aggressive behavior in most subjects .

###20147716
BACKGROUND	Some 50 % of patients with visceral leishmaniasis ( kala-azar ) worldwide live in the Indian state of Bihar .
BACKGROUND	Liposomal amphotericin B is an effective treatment when administered in short courses .
BACKGROUND	We wanted to determine whether the efficacy of a single infusion of liposomal amphotericin B was inferior to conventional parenteral therapy , consisting of 15 alternate-day infusions of amphotericin B deoxycholate .
METHODS	In this open-label study , we randomly assigned 412 patients in a 3:1 ratio to receive either liposomal amphotericin B ( liposomal-therapy group ) or amphotericin B deoxycholate ( conventional-therapy group ) .
METHODS	Liposomal amphotericin B ( at a dose of 10 mg per kilogram of body weight ) was given once , and patients were discharged home 24 hours later .
METHODS	Amphotericin B deoxycholate , which was administered in 15 infusions of 1 mg per kilogram , was given every other day during a 29-day hospitalization .
METHODS	We determined the cure rate 6 months after treatment .
RESULTS	A total of 410 patients -- 304 of 304 patients ( 100 % ) in the liposomal-therapy group and 106 of 108 patients ( 98 % ) in the conventional-therapy group -- had apparent cure responses at day 30 .
RESULTS	Cure rates at 6 months were similar in the two groups : 95.7 % ( 95 % confidence interval [ CI ] , 93.4 to 97.9 ) in the liposomal-therapy group and 96.3 % ( 95 % CI , 92.6 to 99.9 ) in the conventional-therapy group .
RESULTS	Adverse events in the liposomal-therapy group were infusion-related fever or rigors ( in 40 % ) and increased anemia or thrombocytopenia ( in 2 % ) ; such events in the conventional-therapy group were fever or rigors ( in 64 % ) , increased anemia ( in 19 % ) , and hypokalemia ( in 2 % ) .
RESULTS	Nephrotoxicity or hepatotoxicity developed in no more than 1 % of patients in each group .
CONCLUSIONS	A single infusion of liposomal amphotericin B was not inferior to and was less expensive than conventional therapy with amphotericin B deoxycholate .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00628719 . )

###11641670
OBJECTIVE	To compare rectally administered misoprostol to intravenously administered oxytocin for the management of third-stage labor .
METHODS	Subjects were randomized to receive two , 200-microg misoprostol tablets rectally ( study medication ) plus 2 mL saline in Ringer 's lactate intravenously or two lactose tablets rectally plus 20 units oxytocin in Ringer 's lactate intravenously ( control medication ) .
METHODS	Blood loss was determined by estimation , measurement , and change in hematocrit values from admission to postpartum day 1 .
METHODS	Subjects were excluded if cesarean delivery was required .
RESULTS	A total of 325 women underwent analysis .
RESULTS	By estimation , 21 % of subjects and 15 % of controls had postpartum hemorrhage ( P = .17 ) .
RESULTS	By using measured blood loss , we determined that 70 of 154 ( 46 % ) study subjects and 61 of 161 ( 38 % ) control subjects had postpartum hemorrhage ( P = .17 ) .
RESULTS	For 36 ( 23 % ) misoprostol subjects and 18 ( 11 % ) oxytocin subjects at least one additional agent was required to control bleeding ( P = .004 ) .
CONCLUSIONS	Rectal misoprostol ( 400 microg ) was no more effective than intravenous oxytocin in preventing postpartum hemorrhage .

###24388920
OBJECTIVE	In vitro data and pilot data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and precursor lesions .
OBJECTIVE	We conducted a randomized , double-blind , placebo-controlled trial of Polyphenon E ( decaffeinated and enriched green tea catechin extract ) in women with persistent human papillomavirus ( HPV ) infection and low-grade cervical intraepithelial neoplasia ( CIN1 ) to evaluate the potential of Polyphenon E for cervical cancer prevention .
METHODS	Ninety-eight eligible women were randomized to receive either Polyphenon E ( containing 800 mg epigallocatechin gallate ) or placebo once daily for 4 months .
METHODS	The primary study outcome was oncogenic HPV clearance and clearance of CIN1 .
RESULTS	Polyphenon E was shown to be acceptable , safe and well tolerated .
RESULTS	There was no difference in the response rate by treatment allocation .
RESULTS	Complete response , defined as negative for high-risk HPV and normal histopathology , was noted in 7 ( 17.1 % ) and 6 ( 14.6 % ) women in the Polyphenon E and placebo arms , respectively .
RESULTS	Progression , defined as persistent oncogenic HPV with histopathologic evidence of progression , was more common in the Polyphenon E group than in the placebo group [ 6 ( 14.6 % ) vs. 3 ( 7.7 % ) ] .
CONCLUSIONS	Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease , we conclude that 4 months of Polyphenon E intervention did not promote the clearance of persistent high-risk HPV and related CIN1 .
CONCLUSIONS	Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies .

###8829162
OBJECTIVE	To test the effectiveness of a nurse-initiated systematic oral hygiene teaching program-PRO-SELF : Mouth Aware ( PSMA ) - in conjunction with two mouthwashes ( 0.12 % chlorhexidine or sterile water ) in preventing chemotherapy-induced oral mucositis .
METHODS	Randomized , double-blind , placebo-controlled , clinical trial .
METHODS	23 outpatient clinics and office practices in California .
METHODS	222 patients who were starting a cycle of mucositis-inducing chemotherapy .
METHODS	Participants were followed over three chemotherapy cycles .
METHODS	All patients were provided the PSMA program .
METHODS	Random assignment to a mouthwash occurred prior to the development of oral mucositis .
METHODS	Researchers used the Oral Assessment Guide to assess the patients oral cavities monthly ( with the patients cycles of chemotherapy ) and when patients reported any oral changes between cycles .
METHODS	Type of mouthwash , incidence , days to onset , and severity of chemotherapy-induced oral mucositis .
RESULTS	No significant differences existed between the two mouthwashes in regard to incidence , days to onset , and severity of mucositis .
CONCLUSIONS	Because chlorhexidine ( S20 per pint ) was no more effective than water , a substantial cost savings can be realized by rinsing with water .
CONCLUSIONS	Interestingly , the PSMA program appeared to reduce the incidence of mucositis from on a prior estimate of 44 % to less than 26 % .
CONCLUSIONS	A nursing prescription of a systematic oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis .

###17013356
BACKGROUND	The purpose of this study was to examine the immediate effect of single acupuncture stimulation to the most painful point in patients with low back pain .
METHODS	A randomised , evaluator-blinded , sham controlled clinical trial was conducted in which 31 patients with low back pain were randomly allocated to either an acupuncture group ( n = 15 ) or a sham acupuncture group ( n = 16 ) .
METHODS	Both acupuncture and sham acupuncture were performed at the most painful point on the lower back of the subjects .
METHODS	For the acupuncture group , a stainless steel needle was inserted to a depth of 20 mm and manually stimulated ( sparrow pecking method ) for 20 seconds , while for the sham treatment a guide tube without a needle was placed at the point and tapped on the skin .
METHODS	Changes in low back pain were evaluated with a visual analogue scale ( VAS ) and the Schober test .
METHODS	Participants were also asked if they felt the needling sensation or not .
METHODS	The therapy and the evaluation were independently performed by two different acupuncturists .
RESULTS	VAS score and the Schober test score showed significant improvement after treatment as compared with the sham group ( P = 0.02 , 0.001 , respectively ) .
RESULTS	There were no significant differences in the needling sensation between the acupuncture and sham group .
CONCLUSIONS	These results suggest that acupuncture at the most painful point gives immediate relief of low back pain .

###25085447
BACKGROUND	Psychological therapy is effective for symptoms of mental distress , but many groups with high levels of mental distress face significant barriers in terms of access to care , as current interventions may not be sensitive to their needs or their understanding of mental health .
BACKGROUND	There is a need to develop forms of psychological therapy that are acceptable to these groups , feasible to deliver in routine settings , and clinically and cost effective .
METHODS	We developed a culturally sensitive wellbeing intervention with individual , group and sign-posting elements , and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial .
RESULTS	We recruited 57 patients ( 57 % of our target ) from 4 disadvantaged localities in the NW of England .
RESULTS	The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care .
RESULTS	For elders , the largest effects were on CORE-OM and PHQ-9 .
RESULTS	For ethnic minority patients , the largest effect was on PHQ-9 .
RESULTS	Qualitative data suggested that patients found the intervention acceptable , both in terms of content and delivery .
CONCLUSIONS	This exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression , although challenges in recruitment and engagement remain .
CONCLUSIONS	Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs .
BACKGROUND	Current controlled trials ISRCTN68572159 .

###24863677
OBJECTIVE	To assess health-related quality of life ( QoL ) and clinical factors predicting it after tonsillectomy among adult patients with recurrent pharyngitis .
METHODS	Prospective cohort design .
METHODS	Tertiary referral centre .
METHODS	Adults ( n = 153 ) who underwent tonsillectomy for recurrent pharyngitis .
METHODS	QoL 6 months after tonsillectomy measured by the Glasgow Benefit Inventory ( GBI ) .
METHODS	Factors predicting high postoperative QoL were sought using multiple linear regression analysis .
RESULTS	Of the 142 patients ( 93 % of all eligible ) responding to the GBI questionnaire , 94 ( 66 % ) were female ; median age was 26 years ( range 14-65 ) .
RESULTS	GBI Total Scores varied markedly ( range -19 to +69 ) , but on average showed improvement ( median +27 , interquartile range 18-36 ) , most evidently in the GBI Physical Health Score ( median +83 ) , after tonsillectomy .
RESULTS	Among routinely recorded clinical characteristics , the number of prior pharyngitis episodes , frequent throat pain , untreated dental caries and chronically infected tonsils made up the optimal subset of factors for predicting the GBI Total Score .
RESULTS	However , in a random sample of patients ( n = 56 ) for whom preoperative diary-based data were also available , somewhat better predictive ability was achieved based on just two diary items : number of days with throat pain and with fever during the preceding few months ( correlation coefficient , r , between observed and fitted scores improved from 0.39 to 0.55 ) .
RESULTS	Yet , the precision of even these predictions was still quite low .
CONCLUSIONS	Adult patients with recurrent pharyngitis were on average satisfied after tonsillectomy , regardless of the aetiology of the episodes .
CONCLUSIONS	Clinical factors rather modestly predicted which patients benefited most from the operation .

###11796177
OBJECTIVE	to clarify and confirm the renoprotective effects of ACEIs in Japanese type 1 diabetics .
METHODS	a double-blind randomized study using two ACEIs , imidapril ( a prodrug of imdaprilat without an SH-residue ) and captopril as well as placebo was performed .
METHODS	Seventy-nine eligible cases were randomized to receive captopril 37.5 mg ( n = 26 ) , imidapril 5 mg ( n = 26 ) or their placebos ( n = 27 ) daily in a double-blind manner .
RESULTS	urinary albumin excretion ( UAE ) , determined every half year , was significantly decreased by the ACEIs ( placebo vs. ACEIs F = 11.316 , P = 0.001 , placebo vs. captopril F = 4.260 , P = 0.043 , placebo vs. imidapril F = 14.341 , P < 0.001 ) during the study period ( the mean ; 1.48 years ) .
RESULTS	Although the HbA ( 1C ) levels and systolic blood pressure ( BP ) between the three groups were not different , glycemic and BP control significantly affected UAE .
RESULTS	Systolic BP in the placebo group tended to be higher by 7-10 mmHg throughout the study .
CONCLUSIONS	these results suggest that the ACE inhibitors , imidapril and captopril , prevent the increase in UAE in micro and macroalbuminuric patients with type 1 diabetes mellitus and that the target BP might be less than 130/80 mmHg .

###26009832
BACKGROUND	Combination antiretroviral therapy ( ART ) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed .
METHODS	Participants were HIV-1-infected partners randomized to early ART ( CD4 350-550 ) in HPTN052 ( n = 886 , median follow-up = 2.1 years ) , a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries .
METHODS	Adherence was assessed through pill count ( dichotomized at < 95 % ) and through self-report items .
METHODS	Predictors of adherence were mental health and general health perceptions , substance use , binge drinking , social support , sexual behaviors , and demographics .
METHODS	Viral suppression was defined as HIV plasma viral load < 400 copies per milliliter .
METHODS	Adherence counseling and couples ' counseling about safer sex were provided .
METHODS	Logistic and linear regression models using generalized estimating equation for repeated measurements were used .
RESULTS	Through pill count , 82 % of participants were adherent at 1 month and 83.3 % at 1 year .
RESULTS	Mental health was the only psychosocial variable associated with adherence [ pill count , odds ratios ( OR ) = 1.05 , 95 % confidence intervals ( CIs ) : 1.00 to 1.11 ; self-report parameter estimate , OR = 0.02 , 95 % CI : 0.01 to 0.04 ] , although regional differences emerged .
RESULTS	Pill count ( OR = 1.19 , 95 % CI : 1.10 to 1.30 ) and self-report ( OR = 1.42 , 95 % CI : 1.14 to 1.77 ) adherence were associated with viral suppression .
CONCLUSIONS	Although adherence was high among individuals in stable relationships taking ART for prevention , mental health and adherence covaried .
CONCLUSIONS	Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored .
CONCLUSIONS	Adherence and couples ' counseling , feedback about viral suppression , and/or altruism may also help explain the magnitude of adherence observed .

###20484150
OBJECTIVE	Several basic science studies support the existence of non-genomic glucocorticoid signaling in pancreas , liver , and adipocytes , but its clinical relevance has not yet been elucidated .
OBJECTIVE	This study aimed at investigating the rapid effects of hydrocortisone on the human metabolic response to glucose .
METHODS	In a randomized placebo-controlled crossover study , ten healthy men received an i.v. bolus of 0.6 mg/kg hydrocortisone once and placebo once 4 min before the administration of 330 mg/kg glucose .
METHODS	Cortisol , glucose , insulin , C-peptide , ghrelin , and peptide YY ( PYY ) levels were measured during the following 3 h. Minimal model analysis was performed for evaluating the metabolic response .
RESULTS	Hydrocortisone attenuated the rise in plasma glucose during the initial 15 min following glucose administration ( P = 0.039 ) , and it led to lower glucose levels during the first 2 h ( P = 0.017 ) .
RESULTS	This was accompanied by enhanced circulating insulin ( P = 0.02 ) and C-peptide ( P = 0.03 ) levels during the initial 15 min , and a 35 % increase in the first-phase beta-cell function ( P = 0.003 ) .
RESULTS	Hydrocortisone decreased PYY concentrations during the initial 30 min ( P = 0.014 ) , but it did not affect the ghrelin response to glucose .
CONCLUSIONS	One i.v. bolus of hydrocortisone induces rapid effects on carbohydrate metabolism increasing the first-phase beta-cell function .
CONCLUSIONS	The modulation of PYY plasma levels suggests the possible non-genomic effects of glucocorticoids on appetite-regulatory hormones .

###21479818
OBJECTIVE	To obtain an adequate view of the whole small intestine during capsule endoscopy ( CE ) a clear liquid diet and overnight fasting is recommended .
OBJECTIVE	However , intestinal content can hamper vision in spite of these measures .
OBJECTIVE	Our aim was to evaluate tolerance and degree of intestinal cleanliness during CE following three types of bowel preparation .
METHODS	This was a prospective , multicenter , randomized , controlled study .
METHODS	Two-hundred ninety-one patients underwent one of the following preparations : 4L of clear liquids ( CL ) ( group A ; 92 patients ) ; 90mL of aqueous sodium phosphate ( group B ; 89 patients ) ; or 4L of a polyethylene glycol electrolyte solution ( group C ; 92 patients ) .
METHODS	The degree of cleanliness of the small bowel was classified by blinded examiners according to four categories ( excellent , good , fair or poor ) .
METHODS	The degree of patient satisfaction , gastric and small bowel transit times , and diagnostic yield were measured .
RESULTS	The degree of cleanliness did not differ significantly between the groups ( P = 0.496 ) .
RESULTS	Interobserver concordance was fair ( k = 0.38 ) .
RESULTS	No significant differences were detected between the diagnostic yields of the CE ( P = 0.601 ) .
RESULTS	Gastric transit time was 35.73.7 min ( group A ) , 46.18.6 min ( group B ) and 34.65.0 min ( group C ) ( P = 0.417 ) .
RESULTS	Small-intestinal transit time was 276.910.7 min ( group A ) , 249.713.1 min ( group B ) and 245.611.6 min ( group C ) ( P = 0.120 ) .
RESULTS	CL was the best tolerated preparation .
RESULTS	Compliance with the bowel preparation regimen was lowest in group C ( P = 0.008 ) .
CONCLUSIONS	A clear liquid diet and overnight fasting is sufficient to achieve an adequate level of cleanliness and is better tolerated by patients than other forms of preparation .

###22074866
OBJECTIVE	The aim of this study was to assess longitudinal quantitative changes in bone density around different implant loading protocols and implant surfaces measured by digital subtraction radiography ( DSR ) .
METHODS	12 patients received bilateral homologous standard and TiUnite ( Nobel Biocare , Kloten , Switzerland ) single-tooth implants under 2 implant-loading protocols : immediate loading ( 8 patients , 16 implants , 12 maxillary ) and conventional loading ( 4 patients , 8 implants , 4 maxillary ) .
METHODS	Standardized periapical radiographs were taken immediately after implant placement ( baseline image ) and at the 3-month , 6-month and 12-month follow ups .
METHODS	Radiographic images were digitized and submitted to digital subtraction using the DSR system ( Electro Medical System , Nyon , Switzerland ) , resulting in three subtracted images .
METHODS	Quantitative analysis of bone density was performed using Image Tool software ( University of Texas Health Science Centre , San Antonio , TX ) to assess pixel value changes in five areas around the implants ( crestal , subcrestal , medial third , apical-lateral and apical ) .
RESULTS	Repeated-measures analysis of variance showed that grey levels were significantly influenced by follow-up time and implant-loading protocol .
RESULTS	A linear increase in grey levels was found for immediate loading ( IML ) implants and a significant decrease in grey levels was observed in the 12-month follow up for conventional loading implants .
RESULTS	No effect of implant surface treatment was observed .
CONCLUSIONS	In conclusion , IML protocol induced mineral bone gain around single-tooth implants after the first year under function for cases with favourable bone conditions .

###21839654
OBJECTIVE	Chronic cerebrospinal venous insufficiency ( CCSVI ) is associated with multiple sclerosis ( MS ) .
OBJECTIVE	The objective of the study was to see if percutaneous transluminal angioplasty ( PTA ) of duplex-detected lesions , of the internal jugular and/or azygous veins , was safe , burdened by a significant restenosis rate , and whether there was any evidence that treatment reduced MS disease activity .
METHODS	This was a case-control study .
METHODS	We studied 15 patients with relapsing-remitting MS and duplex-detected CCSVI .
METHODS	Eight patients had PTA in addition to medical therapy ( immediate treatment group ( ITG ) ) , whereas seven had treatment with PTA after 6 months of medical therapy alone ( delayed treatment group ( DTG ) ) .
RESULTS	No adverse events occurred .
RESULTS	At 1 year , there was a restenosis rate of 27 % .
RESULTS	Overall , PTA was followed by a significant improvement in functional score compared with baseline ( p < 0.02 ) .
RESULTS	The annualised relapse rate was 0.12 % in the ITG compared with 0.66 % in the DTG ( p = NS ) .
RESULTS	Magnetic resonance imaging ( MRI ) blindly demonstrates a trend for fewer T2 lesions in the ITG ( p = 0.081 ) , corresponding to a 10 % decrease in the ITG compared with a 23 % increase in the DTG over the first 6 months of the study .
CONCLUSIONS	This study further confirms the safety of PTA treatment in patients with CCSVI associated with MS. The results , despite the significant rate of restenosis , are encouraging and warrant a larger multicentre double-blinded , randomised study .

###18260773
BACKGROUND	This study compared the accuracy and precision of five blood glucose ( BG ) meters .
METHODS	Diabetes patients undergoing venipuncture for glucose testing were randomized to one of two groups consisting of three meters : FreeStyle Flash ( Abbott Diabetes Care , Alameda , CA ) , Accu-Chek Advantage ( Roche Diagnostics Corp. , Indianapolis , IN ) , and Accu-Chek Compact Plus ( Roche Diagnostics ) or FreeStyle Flash , Ascensia Contour ( Bayer Healthcare , Diagnostic Division , Tarrytown , NY ) , and BD Logic ( BD Diabetes Care , Franklin Lake , NJ ) .
METHODS	Within 5 min following venipuncture , duplicate finger BG measurements from three ipsilateral fingers were taken .
METHODS	Finger glucose measurements were compared with laboratory reference values .
METHODS	Accuracy was assessed by a Clarke error grid analysis ( EGA ) and within 10 % of the laboratory value criteria .
METHODS	Meter precision was determined by calculating the absolute mean differences in glucose values between duplicate samples .
RESULTS	Finger sticks were obtained from 202 patients .
RESULTS	Mean venipuncture BG was 148 mg/dL ( SD + / - mg/64 dL ; range 25-439 mg/dL ) .
RESULTS	Accuracy by Clarke EGA ( Zone A results ) was demonstrated in 69 % of Advantage samples , 75 % of Compact Plus , and 96 % of the first group of Flash versus 88 % of the Contour , 67 % of the Logic , and 91 % of the second Flash samples ( P < 0.05 for both Flash and Contour ) .
RESULTS	Meter accuracy using the 10 % criteria was demonstrated in 30 % , 38 % , 70 % , 46 % , 48 % , and 68 % of the samples , respectively ( P < 0.05 for both Flash groups compared to each of the other meters ) .
RESULTS	There were no differences in meter precision .
CONCLUSIONS	No statistically significant differences in accuracy were evident using the Clarke EGA criteria ( pooled results of Zone A and B ) , though the more strict 20 % accuracy criteria ( Zone A results only ) found the Flash and Contour to have significantly greater accuracy compared to the Advantage , Compact Plus , and the Logic .
CONCLUSIONS	Using the 10 % accuracy criteria found the Flash to have significantly greater accuracy than each of the other four meters .
CONCLUSIONS	All five meters demonstrated similar precision .

###24711481
OBJECTIVE	Syncope is a cause of significant morbidity in sick sinus syndrome ( SSS ) which may not be resolved with permanent pacemaker therapy .
OBJECTIVE	We aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with SSS .
METHODS	We studied 1415 patients ( mean age 72.9 years , SD 11.1 ) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing ( n = 707 ) or rate-responsive dual chamber pacing ( n = 708 ) .
METHODS	Main outcome measures were patient-reported syncope after pacemaker implantation and mortality .
RESULTS	Mean follow-up was 5.4 years ( SD 2.6 ) .
RESULTS	A total of 247 ( 17.5 % ) patients experienced syncope after pacemaker implantation ( 135 ( 19 % ) from the rate-responsive single chamber pacing group , and 112 ( 15.8 % ) from the rate-responsive dual chamber pacing group .
RESULTS	Predictors of syncope post pacemaker implantation included : age 0-39 years ( HR 2.9 , 95 % CI 1.4 to 6.3 , p = 0.01 ; reference range 60-79 years ) , age 80 years ( HR 1.4 , 95 % CI 1.0 to 1.8 , p = 0.03 ) , syncope prior to pacemaker implant ( HR 1.8 , 95 % CI 1.4 to 2.3 , p < 0.001 ) , previous myocardial infarction ( HR 1.5 , 95 % CI 1.1 to 2.1 , p = 0.03 ) , heart failure ( HR 1.4 , 95 % CI 1.0 to 1.9 , p = 0.046 ) , and high Charlson comorbidity index ( HR 1.6 , 95 % CI 1.1 to 2.2 , p = 0.01 ) .
RESULTS	Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted HR 1.6 , 95 % CI 1.3 to 2.1 , p < 0.001 ) .
CONCLUSIONS	Syncope in paced patients with SSS is common , and is associated with higher mortality .
CONCLUSIONS	The predictors identified in this study suggest a multifactorial aetiology of syncope .

###22543342
OBJECTIVE	The goal was to determine the effectiveness of the posterior pericardiotomy technique in preventing the development of early and late pericardial effusions ( PEs ) and to determine the role of anxiety level for the detection of late pericardial tamponade ( PT ) .
METHODS	We divided 100 patients randomly into 2 groups , the posterior pericardiotomy group ( n = 50 ) and the control group ( n = 50 ) .
METHODS	All patients undergoing coronary artery bypass grafting surgery ( CABG ) , valvular heart surgery , or combined valvular and CABG surgeries were included .
METHODS	The posterior pericardiotomy technique was performed in the first group of 50 patients .
METHODS	Evaluations completed preoperatively , postoperatively on day 1 , before discharge , and on postoperative days 5 and 30 included electrocardiographic study , chest radiography , echocardiographic study , and evaluation of the patient 's anxiety level .
METHODS	Postoperative causes of morbidity and durations of intensive care unit and hospital stays were recorded .
RESULTS	The 2 groups were not significantly different with respect to demographic and operative data ( P > .05 ) .
RESULTS	Echocardiography evaluations revealed no significant differences between the groups preoperatively ; however , before discharge the control group had a significantly higher number of patients with moderate , large , and very large PEs compared with the pericardiotomy group ( P < .01 ) .
RESULTS	There were 6 cases of late PT in the control group , whereas there were none in the pericardiotomy group ( P < .05 ) .
RESULTS	Before discharge and on postoperative day 15 , the patients in the pericardiotomy group showed significant improvement in anxiety levels ( P = .03 and .004 , respectively ) .
RESULTS	No differences in postoperative complications were observed between the 2 groups .
CONCLUSIONS	Pericardiotomy is a simple , safe , and effective method for reducing the incidence of PE and late PT after cardiac surgery .
CONCLUSIONS	It also has the potential to provide a better quality of life .

###23287697
OBJECTIVE	Several trials demonstrated the life saving role of implantable cardioverter-defibrillators ( ICD ) in primary prevention of sudden cardiac death ( SCD ) .
OBJECTIVE	The aim was to evaluate the clinical characteristics and 4-year outcome of consecutive patients treated in clinical practice by prophylactic ICD implantation on the basis of class I recommendations and up-to-date ICD programming .
RESULTS	IRIDE multi-center , prospective and observational study enrolled 604 consecutive patients ( mean age : 66 10 years ) treated by ICD between 01/01/2006 and 30/06/2010 .
RESULTS	Main characteristics were similarly distributed among the inclusion criteria of MADIT II ( 24 % ) , SCD-HeFT ( 24 % ) , COMPANION ( 26 % ) and MADIT-CRT ( 18 % ) trials , while a small number of patients met the MUSTT and MADIT ( 7 % ) inclusion criteria .
RESULTS	Single-chamber ICDs were implanted in 168 ( 28 % ) patients , dual-chamber in 167 ( 28 % ) and biventricular in 269 ( 43 % ) patients .
RESULTS	ATP programming was activated in 546 ( 90 % ) patients .
RESULTS	Overall survival and rate of appropriate ICD intervention by ATP and/or shock at 12-24-36-48 months of follow-up were 94 % , 89 % , 80 % , 75 % and 16 % , 28 % , 37 % and 50 % , respectively .
RESULTS	No difference in mortality rate between the groups who received or did not receive appropriate ICD interventions was demonstrated ( p = ns ) .
CONCLUSIONS	The IRIDE study confirms the effectiveness in real world practice of ICD implantation in patients at risk of SCD .
CONCLUSIONS	The life saving role of ICD therapy increases as the duration of follow-up is prolonged and the survival benefit is similar in patients who received or did not receive appropriate device treatment , thus suggesting a beneficial effect of up-to-date device programming .

###20003405
BACKGROUND	Occupational health professionals may play an important role in preventive health promotion activities for employees .
BACKGROUND	However , due to a lack of knowledge and evidence - and practice based methods and strategies , interventions are hardly being implemented by occupational physicians to date .
BACKGROUND	The aim of the Balance@Work project is to develop , evaluate , and implement an occupational health guideline aimed at the prevention of weight gain among employees .
METHODS	Following the guideline development protocol of the Netherlands Society of Occupational Medicine and the Intervention Mapping protocol , the guideline was developed based on literature , interviews with relevant stakeholders , and consensus among an expert group .
METHODS	The guideline consists of an individual and an environmental component .
METHODS	The individual component includes recommendations for occupational physicians on how to promote physical activity and healthy dietary behavior based on principles of motivational interviewing .
METHODS	The environmental component contains an obesogenic environment assessment tool .
METHODS	The guideline is evaluated in a randomised controlled trial among 20 occupational physicians .
METHODS	Occupational physicians in the intervention group apply the guideline to eligible workers during 6 months .
METHODS	Occupational physicians in the control group provide care as usual .
METHODS	Measurements take place at baseline and 6 , 12 , and 18 months thereafter .
METHODS	Primary outcome measures include waist circumference , daily physical activity and dietary behavior .
METHODS	Secondary outcome measures include sedentary behavior , determinants of behavior change , body weight and body mass index , cardiovascular disease risk profile , and quality of life .
METHODS	Additionally , productivity , absenteeism , and cost-effectiveness are assessed .
CONCLUSIONS	Improving workers ' daily physical activity and dietary behavior may prevent weight gain and subsequently improve workers ' health , increase productivity , and reduce absenteeism .
CONCLUSIONS	After an effect - and process evaluation the guideline will be adjusted and , after authorisation , published .
CONCLUSIONS	Together with several implementation aids , the published guideline will be disseminated broadly by the Netherlands Society of Occupational Medicine .
BACKGROUND	ISRCTN73545254/NTR1190 .

###16453054
OBJECTIVE	The aim of this study was to assess the effectiveness of a community-based , low-intensity exercise programme in older adults from socio-economically and historically disadvantaged communities .
METHODS	Three community centres were selected : two were allocated to the same 20-week , twice-weekly exercise program ( EX1 , n = 38 ; EX2 , n = 32 ) ; and a third to relaxation classes ( control/CTL ; n = 21 ) .
METHODS	Measurements at baseline , 10 and 20 weeks included field tests for anthropometry , static and dynamic balance , gait , upper and lower body strength , 6-minute walk test , blood pressure , activities of daily living ( ADL ) , instrumental activities of daily living ( IADL ) , physical activity recall and self perceived health status .
RESULTS	Exercise training significantly improved dynamic balance in both groups ( 75.1 + / -31.5 vs 55.3 + / -13.6 s , and 53.3 + / -17.0 vs 37.0 + / -10.4 s , for EX1 and EX2 , respectively , p < 0.001 compared to CTL ( 57 + / -27 vs 53 + / -15 s ) .
RESULTS	Lower body strength , as measured by the number of sit-to-stand repetitions in 10 s was also significantly improved in both EX1 and EX2 ( p < 0.001 ) .
RESULTS	No significant changes occurred in the CTL group .
RESULTS	Systolic blood pressure decreased in both EX1 and EX2 from baseline to 20 weeks ( 147.8 + / -12.8 vs 143.9 + / -3.3 mmHg and 143.0 + / -13.9 vs 137.4 + / -14.5 mmHg , respectively , p < 0.009 , compared to CTL ( 147 + / -13 to 150 + / -16 mmHg ) .
RESULTS	Furthermore , in a sub sample of subjects who were hypertensive at the outset , exercise intervention was associated with a significant decrease in systolic blood pressure ( n = 26 ; 146 + / -14 mmHg to 140 + / -14 mmHg ; p = 0.005 ) .
RESULTS	Variables unaffected by exercise training were upper body strength , body composition and fat distribution , 20 m walk , cardiovascular endurance , time spent in recreational activities , self perceived health status and ADL .
CONCLUSIONS	A community-based , low intensity exercise programme improved dynamic balance and lower body strength in community dwelling older adults and improved blood pressure , particularly in those who were hypertensive .

###10470568
OBJECTIVE	Air leaks around the mask are very likely to occur during noninvasive ventilation , in particular when prolonged ventilatory treatment is required .
OBJECTIVE	It has been suggested that leaks from the mask may impair the expiratory trigger cycling mechanism when inspiratory pressure support ventilation ( PSV ) is used .
OBJECTIVE	The aim of this study was to compare the short-term effect of two different expiratory cycling mechanisms ( time-cycled vs flow-cycled ) during noninvasive inspiratory pressure support ventilation ( NIPSV ) on patient-ventilator synchronisation in severe hypoxemic respiratory failure .
METHODS	Six patients with acute lung injury ( ALI ) due to acquired immunodeficiency syndrome ( AIDS ) - related opportunistic pneumonia were enrolled in the protocol .
METHODS	Each subject was first studied during spontaneous breathing with a Venturi oxygen mask ( SB ) and successively submitted to a randomly assigned 20 ' conventional flow-cycling ( NIPSVfc ) or time-cycling inspiratory pressure support ventilation ( NIPSVtc ) .
METHODS	The pre-set parameters were : inspiratory pressure of 10 cm H2O , PEEP of 5 cm H2O for the same inspired oxygen fraction as during SB .
METHODS	A tight fit of the mask was avoided in order to facilitate air leaks around the mask .
METHODS	The esophageal pressure time product ( PTPes ) and tidal swings ( delta Pes ) were measured to evaluate the patient 's respiratory effort .
METHODS	A subjective `` comfort score '' and the difference between patient and machine respiratory rate [ delta RR ( p-v ) ] , calculated on esophageal and airway pressure curves , were used as indices of patient-machine interaction .
RESULTS	Air leaks through the mask occurred in five out of six patients .
RESULTS	The values of PEEPi ( < 1.9 cm H2O ) excluded significant expiratory muscle activity .
RESULTS	NIPSVtc significantly reduced PTPes , delta Pes , and delta RR ( p-v ) when compared to NIPS-Vfc [ 230 + / - 41 ( SE ) vs 376 + / - 72 cm H2O.s.min-1 ; 8 + / - 2 vs 13 + / - 2 cm H2O ; 1 + / - 1 vs 9 + / - 2 br.min-1 ; respectively ] with a concomitant significant improvement of the `` comfort score '' .
CONCLUSIONS	In the presence of air leaks a time-cycled expiratory trigger provides a better patient-machine interaction than a flow-cycled expiratory trigger during NIPSV .

###16041207
BACKGROUND	The benefit of adjuvant therapy in curatively resected lymph node-positive colon cancer was established using 5-fluorouracil ( 5-FU ) and levamisole ( LEV ) for 12 months .
BACKGROUND	5-FU cytotoxicity can be modulated by folinic acid ( FA ) or interferon-alpha ( INF-alpha ) .
BACKGROUND	The aim of this study was to investigate the efficacy of modulating 5-FU + LEV by either FA or IFN-alpha in the adjuvant treatment of high-risk colon cancer .
METHODS	Patients with curatively resected colon cancer ( stages UICC IIb and III ) were stratified according to T , N , and participating center and randomized to receive a 12-month treatment using 5-FU + LEV alone or in combination with FA or IFN-alpha .
RESULTS	A total of 855 of 904 entered patients ( 94.6 % ) were eligible .
RESULTS	The median follow-up of all eligible patients was 4.6 years .
RESULTS	Addition of FA to 5-FU + LEV improved recurrence-free and overall survival in comparison with 5-FU + LEV alone ( P = 0.007 and P = 0.004 , respectively , 1-sided ) .
RESULTS	The 5-year overall survival rates were 60.5 % ( 95 % confidence interval , 54.3-66 .7 ) and 72.0 % ( 95 % confidence interval , 66.5-77 .5 ) for 5-FU + LEV and 5-FU + LEV + FA , respectively .
RESULTS	Addition of INF-alpha showed a tendency to improve recurrence-free survival , however , without altering overall survival .
RESULTS	Toxicities ( WHO III + IV ) were generally tolerable except one toxic death in the control arm and were observed in 9.9 % of the patients receiving 5-FU + LEV alone and in 13.3 % and in 30.7 % of patients receiving additional FA and IFN-alpha , respectively .
CONCLUSIONS	Addition of IFN-alpha was associated with increased toxicity without markedly influencing the outcome and should therefore not be recommended for adjuvant treatment .
CONCLUSIONS	Addition of FA increased the 5-year recurrence-free and overall survival rate by 9.3 and 11.5 percentage points , respectively .
CONCLUSIONS	5-FU + LEV + FA for 12 months may be an effective adjuvant treatment option for locally advanced high-risk colon cancer .

###15319721
BACKGROUND	The internet CD-ROM thoracic surgery ( TS ) e-learning system was implemented in 2001 as a prospective randomized trial testing resident acceptance and educational impact of a unique web-based curriculum system on prematriculated TS residents .
BACKGROUND	The Prerequisite Curriculum ( PRC ) contains 75 segments organized with textbook and case-based navigational systems .
METHODS	Web-based technology tracked the PRC use for each resident .
METHODS	Of 142 residents , 138 thoracic surgery residents matching in 2001 for 2002 matriculation participated in a prospective randomized trial comparing the PRC system to a control group .
METHODS	Two sets of in-training exams , as well as resident and faculty knowledge/performance surveys , were used from July 2001 through January 2004 for ongoing , blinded multidimensional evaluation .
RESULTS	Most residents ( 55/69 ) responded to the written prematriculation surveys and indicated they used the PRC ( 43/55 ) , averaging 1.45 hours weekly .
RESULTS	The PRC was rated as easy to use ( 8.3 / 10 ) , a valuable study guide ( 7.7 / 10 ) , and superior to traditional texts and journals for preresidency preparation ( 7.9 / 10 ) .
RESULTS	Web-based tracking revealed that 47/69 actually used the PRC .
RESULTS	Sessions averaged 23.3 minutes with an average of 148 sessions over the prematriculation year .
RESULTS	The in-training exam performance when evaluated at 1 and 9 months into the TS residency revealed a positive correlation between examination performance and PRC use .
RESULTS	After TS residency matriculation , the self-evaluated knowledge and performance satisfaction scores were superior among PRC users in all categories .
RESULTS	Simultaneous TS faculty evaluations of the same resident groups demonstrated smaller , but significant group differences .
CONCLUSIONS	The implementation of the TS PRC has been exciting and successful .
CONCLUSIONS	Future multidisciplinary curricular progress will hopefully continue to build upon this e-learning strategy .

###17632309
OBJECTIVE	To compare the results of laser subepithelial keratomileusis ( LASEK ) and laser in situ keratomileusis ( LASIK ) for the correction of moderate myopia .
METHODS	We performed a retrospective , single-masked , interventional study of 80 consecutive eyes .
METHODS	Forty eyes that had undergone LASEK to correct myopia of -2.0 to -6.0 D were compared with age and refraction matched patients treated with LASIK .
METHODS	All eyes had been operated by the same experienced surgeon using the same laser ( Technolas 217 ) .
METHODS	Mitomycin C was not used in any patient .
RESULTS	Eighty eyes were reviewed ( 40 treated with LASEK , 40 treated with LASIK ) .
RESULTS	The preoperative mean sphere was -3.8 D ( range -2 to -6 D ) and mean cylinder was -0.7 D ( range 0 to -2 D ) in both groups .
RESULTS	Postoperative uncorrected visual acuity was worse in LASEK eyes 1 and 7 days postoperatively ( p = 0.0001 ) , although the difference 7 days postoperatively ( < one letter ) was not clinically meaningful .
RESULTS	No significant differences were noted 3 months postoperatively either in the uncorrected visual acuity , in the best-spectacle corrected visual acuity , or in the residual refractive error .
RESULTS	Nine LASEK-treated eyes showed a postoperative refraction of +1 D or more .
RESULTS	These cases had a higher preoperative sphere ( -4.5 D ) compared with the nonovercorrected LASEK-treated eyes ( -3.5 D ) ( p = 0.03 ) .
RESULTS	One eye after LASEK and four eyes after LASIK needed retreatment ( p > 0.05 ) .
CONCLUSIONS	LASEK and LASIK seem to be similar in terms of safety and efficacy for the correction of moderate myopia .
CONCLUSIONS	Nevertheless , a trend toward overcorrection was found in the LASEK group in correlation with a higher preoperative refractive error .

###8139084
OBJECTIVE	To characterize the hepatic effects of tacrine treatment in patients with Alzheimer 's disease .
METHODS	Controlled trials of tacrine therapy consisting of two blinded , parallel-group trials ; three blinded , enrichment-design trials ; and their respective open-label extensions .
METHODS	Multicenter clinical trials in the United States , France , and Canada .
METHODS	A total of 2446 men and women at least 50 years of age with a diagnosis of probable Alzheimer 's disease of mild to moderate severity and in good health without significant hepatic , cardiovascular , or renal disease .
METHODS	Administration of tacrine vs placebo , with weekly measurement of serum hepatic enzymes .
METHODS	Incidence , maximum severity , and timing of event for serum alanine aminotransferase ( ALT ) elevation .
RESULTS	Among the 2446 patients who received tacrine in clinical trials , ALT levels greater than the upper limit of normal ( ULN ) occurred on at least one occasion in 1203 patients ( 49 % ) , ALT levels greater than three times the ULN occurred in 621 patients ( 25 % ) , and ALT levels greater than 20 times the ULN occurred in 40 patients ( 2 % ) .
RESULTS	The elevated ALT levels were generally asymptomatic and occurred more frequently in women than men .
RESULTS	The mean time from initiation of tacrine treatment to first ALT level greater than three times the ULN was 50 days , and 90 % of all initial ALT levels greater than three times the ULN occurred during the first 12 weeks of treatment .
RESULTS	Of 145 patients who discontinued tacrine treatment because of an ALT level greater than three times the ULN and were rechallenged , 127 ( 88 % ) were able to resume long-term therapy with the drug .
RESULTS	In all instances , discontinuing tacrine completely reversed elevations in ALT levels , and no deaths related to hepatotoxicity occurred .
CONCLUSIONS	These data suggest that the potential for serious hepatic toxicity can be reduced through careful monitoring of ALT levels in patients who may benefit from tacrine therapy .

###12632137
BACKGROUND	Reports on intrapleural analgesia ( IPA ) are conflicting .
BACKGROUND	The current study assessed the effect of a single-dose thoracoscopic bilateral intrapleural anesthetic administration on the immediate postoperative recovery room and 24-h pain control .
METHODS	Fifty patients with primary palmar hyperhidrosis were randomly classified into two groups to receive either 20 ml of 0.5 % bupivacaine and 5 mg/ml epinephrine or 0.9 % NaCl in each thoracic cavity at the end of thoracoscopic T2-T3 sympathectomy .
METHODS	The degree of early postoperative pain was estimated by visual analog scale ( VAS ) .
METHODS	The 24-h parenteral opioid analgesic requirement was recorded .
RESULTS	The immediate postoperative VAS score ( 1.46 + / - 0.41 vs 2.0 + / - 0.61 , p = 0.03 ) , opioid consumption ( 0.42 + / - 0.36 vs 0.65 + / - 0.28 , p = 0.0133 ) , and 24-h opioid consumption ( 1.02 + / - 0.80 vs 1.48 + / - 0.84 , p = 0.05 ) were significantly reduced following IPA compared to those of the control group .
CONCLUSIONS	IPA is a simple and effective means for postoperative pain control following thoracoscopic upper dorsal sympathectomy .

###21214709
OBJECTIVE	To evaluate the effects of propofol , on isoflurane minimum alveolar concentration ( MAC ) and cardiovascular function in mechanically ventilated goats .
METHODS	Prospective , randomized , crossover experimental study .
METHODS	Six goats , three does and three wethers .
METHODS	General anaesthesia was induced with isoflurane in oxygen .
METHODS	Following endotracheal intubation , anaesthesia was maintained with isoflurane in oxygen .
METHODS	Intermittent positive pressure ventilation was applied .
METHODS	Baseline isoflurane MAC was determined , the noxious stimulus used being clamping a claw .
METHODS	The goats then received , on separate occasions , three propofol treatments intravenously : bolus of 0.5 mg kg ( -1 ) followed by a constant rate infusion ( CRI ) of 0.05 mg kg ( -1 ) minute ( -1 ) ( treatment LPROP ) ; bolus of 1.0 mg kg ( -1 ) followed by a CRI of 0.1 mg kg ( -1 ) minute ( -1 ) ( treatment MPROP ) , bolus of 2.0 mg kg ( -1 ) followed by a CRI of 0.2 mg kg ( -1 ) minute ( -1 ) ( treatment HPROP ) .
METHODS	Isoflurane MAC was re-determined following propofol treatments .
METHODS	Plasma propofol concentrations at the time of MAC confirmation were measured .
METHODS	Cardiopulmonary parameters were monitored throughout the anaesthetic period .
METHODS	Quality of recovery was scored .
METHODS	The Friedman test was used to test for differences between isoflurane MACs .
METHODS	Medians of repeatedly measured cardiovascular parameters were tested for differences between and within treatments using repeated anova by ranks ( p < 0.05 for statistical significance ) .
RESULTS	Isoflurane MAC [ median ( interquartile range ) ] was 1.37 ( 1.36-1 .37 ) vol % .
RESULTS	Propofol CRI significantly reduced the isoflurane MAC , to 1.15 ( 1.08-1 .15 ) , 0.90 ( 0.87-0 .93 ) and 0.55 ( 0.49-0 .58 ) vol % following LPROP , MPROP and HPROP treatment , respectively .
RESULTS	Increasing plasma propofol concentrations strongly correlated ( Spearman rank correlation ) with decrease in MAC ( Rho = 0.91 ) .
RESULTS	Cardiovascular function was not affected significantly by propofol treatment .
RESULTS	Quality of recovery was satisfactory .
CONCLUSIONS	In goats , propofol reduces isoflurane MAC in a dose-dependent manner with minimal cardiovascular effects .

###12568834
OBJECTIVE	To compare the therapeutic efficacy of hormone replacement therapy ( HRT ) and tacrine in Alzheimer 's disease .
METHODS	Six-month , randomized , open-label study .
METHODS	University hospital .
METHODS	Fifty-five women with mild to moderate Alzheimer 's disease were randomly assigned to tacrine ( n = 26 ) or HRT ( n = 29 ) .
METHODS	In the tacrine group , an initial dose of 40 mg/day was increased up to 160 mg/day .
METHODS	In the HRT group , conjugated equine estrogen was given to patients without uteri ( n = 3 ) or together with micronized progesterone to patients with uteri ( n = 26 ) .
METHODS	Mini-Mental State Examination ( MMSE ) , Hopkins Verbal Learning Test , Boston Naming Test , Controlled Oral Word Association Test , Geriatric Depression Scale , Hamilton Depression Scale ( HDS ) , and Instrumental Activities of Daily Living ( IADL ) .
RESULTS	Thirty-three patients who completed the outcome measures ( tacrine , 17 ; HRT , 16 ) were included in an intent-to-treat analysis .
RESULTS	The results did not differ between groups except for IADL , which rated more highly after HRT .
RESULTS	Apolipoprotein E genotype effects were assessed .
RESULTS	MMSE and HDS scores were improved after tacrine treatment in epsilon 4-negative patients .
CONCLUSIONS	Overall efficacy of estrogen plus progesterone combination was similar to tacrine for cognition and mood , but greater for ADL .
CONCLUSIONS	In epsilon 4-negative patients , tacrine is preferable for cognition and mood .

###17955656
OBJECTIVE	To observe the effect of Lianbai liquid in prevention and treatment of acute radiation dermal injury .
METHODS	From May 2000 to December 2005 , 126 cancer patients were randomly divided into a prevention group of 75 cases given externally topical application of Lianbai liquid since the first radiotherapy , and a control group I of 51 cases given only advice after radiotherapy ; while the other 92 cancer patients who had already had grade III acute radiation-induced dermal injury were randomly divided into a treatment group of 54 cases treated by externally topical use of Lianbai liquid , and a control group II of 38 cases treated by topical use of norfloxacin .
METHODS	Clinical evaluation was carried out according to the CTC.V2 .0 standard stipulated by NCI for classifying acute radiation dermal injury .
RESULTS	The incidence of skin reaction was 32.0 % in the prevention group and 92.2 % in the control group I , with an obvious difference between the two groups ( chi2 = 54.163 , P < 0.01 ) .
RESULTS	Mild radioactive reaction ( grade I and II ) was 28.0 % ( 21/75 ) in the prevention group and 70.6 % ( 36/51 ) in the control group I , with a remarkable difference between the two groups ( chi2 = 22.226 , P < 0.01 ) .
RESULTS	The effective rate for grade III dermal injury was 92.6 % ( 50/54 ) in the treatment group and 65.9 % ( 25/38 ) in the control group II , with a remarkable difference between the two groups ( chi2 = 6.018 , P = 0.024 ) .
RESULTS	The wound-healing time was 11.07 + / -2.21 days in the treatment group and 18.08 + / -1.76 days in the control group II , with a remarkable difference between the two groups ( u = 16.932 , P < 0.01 ) .
CONCLUSIONS	Lianbai liquid can effectively prevent the radiation dermatitis , and treat grade III acute radiation dermal injury with obvious curative effect .

###23532888
OBJECTIVE	This randomized , double-blind , placebo-controlled , phase IIb study evaluated adding sorafenib to first-line modified FOLFOX6 ( mFOLFOX6 ) for metastatic colorectal cancer ( mCRC ) .
METHODS	Patients were randomized to sorafenib ( 400 mg b.i.d. ) or placebo , combined with mFOLFOX6 ( oxaliplatin 85 mg/m ( 2 ) ; levo-leucovorin 200 mg/m ( 2 ) ; fluorouracil 400 mg/m ( 2 ) bolus and 2400 mg/m ( 2 ) continuous infusion ) every 14 days .
METHODS	Primary endpoint was progression-free survival ( PFS ) .
METHODS	Target sample was 120 events in 180 patients for > 85 % power ( two-sided = 0.20 ) to detect an HR = 0.65 .
RESULTS	Of 198 patients randomized , median PFS for sorafenib plus mFOLFOX6 was 9.1 months versus 8.7 months for placebo plus mFOLFOX6 ( HR = 0.88 ; 95 % CI , 0.64-1 .23 ; P = 0.46 ) .
RESULTS	There was no difference between treatment arms for overall survival .
RESULTS	Subgroup analyses of PFS and overall survival showed no difference between treatment arms by KRAS or BRAF status ( mutant and wild type ) .
RESULTS	The most common grade 3/4 adverse events in the sorafenib and placebo arms were neutropenia ( 48 % vs. 22 % ) , peripheral neuropathy ( 16 % vs. 21 % ) , and grade 3 hand-foot skin reaction ( 20 % vs. 0 % ) .
RESULTS	Treatment discontinuation because of adverse events was 9 % and 6 % , respectively .
RESULTS	Generally , dose intensity ( duration and cumulative doses ) was lower in the sorafenib arm than in the placebo arm .
CONCLUSIONS	This study did not detect a PFS benefit with the addition of sorafenib to first-line mFOLFOX6 for mCRC .
CONCLUSIONS	KRAS and BRAF status did not seem to impact treatment outcomes but the subgroups were small .
CONCLUSIONS	These results do not support further development of sorafenib in combination with mFOLFOX6 in molecularly unselected patients with mCRC .

###17967640
OBJECTIVE	To investigate the prophylactic antiemetic effect of midazolam after middle ear surgery .
METHODS	A prospective , randomized , double-blind , placebo-controlled study .
METHODS	Ninety women patients undergoing middle ear surgery with general anesthesia received intravenously either midazolam 0.075 mg/kg or normal saline ( n = 45 each ) after induction of anesthesia .
METHODS	The incidence and severity of postoperative nausea and vomiting , rescue antiemetics , pain intensity , and side effects such as headache , dizziness , and drowsiness were assessed during the first 24 hours after anesthesia .
RESULTS	Midazolam groups showed total incidence and severity of nausea and vomiting .
RESULTS	Patients who required rescue antiemetics were significantly lower than in saline group ( P < 0.05 ) , but there were no significant differences in pain intensity and side effects such as headache , dizziness , and drowsiness between groups .
CONCLUSIONS	Midazolam 0.075 mg/kg is effective for reducing nausea and vomiting after middle ear surgery .

###22429384
BACKGROUND	Decision aids are often used to assist individuals confronted with a diagnosis of a serious illness to make decisions about treatment options .
BACKGROUND	However , they are rarely utilised to help those with chronic or age related conditions to make decisions about care services .
BACKGROUND	Decision aids should also be useful for carers of people with decreased decisional capacity .
BACKGROUND	These carers ' choices must balance health outcomes for themselves and for salient others with relational and value-based concerns , while relying on information from health professionals .
BACKGROUND	This paper reports on a study that both developed and pilot tested a decision aid aimed at assisting carers to make evaluative judgements of community services , particularly respite care .
METHODS	A mixed method sequential study , involving qualitative development and a pilot randomised controlled trial , was conducted in Tasmania , Australia .
METHODS	We undertook 13 semi-structured interviews and three focus groups to inform the development of the decision aid .
METHODS	For the randomised control trial we randomly assigned 31 carers of people with dementia to either receive the service decision aid at the start or end of the study .
METHODS	The primary outcome was measured by comparing the difference in carer burden between the two groups three months after the intervention group received the decision aid .
METHODS	Pilot data was collected from carers using interviewer-administered questionnaires at the commencement of the project , two weeks and 12 weeks later .
RESULTS	The qualitative data strongly suggest that the intervention provides carers with needed decision support .
RESULTS	Most carers felt that the decision aid was useful .
RESULTS	The trial data demonstrated that , using the mean change between baseline and three month follow-up , the intervention group had less increase in burden , a decrease in decisional conflict and increased knowledge compared to control group participants .
CONCLUSIONS	While these results must be interpreted with caution due to the small sample size , all intervention results trend in a direction that is beneficial for carers and their decisional ability .
CONCLUSIONS	Mixed method data suggest the decision aid provides decisional support that carers do not otherwise receive .
CONCLUSIONS	Decision aids may prove useful in a community health services context .
BACKGROUND	ISRCTN : ISRCTN32163031 .

###15759065
OBJECTIVE	To examine the effectiveness of a telephone interpersonal counseling ( TIP-C ) intervention compared to a usual care attentional control for symptom management ( depression and fatigue ) and quality of life ( positive and negative affect , stress ) for women with breast cancer .
METHODS	Experimental with repeated measures .
METHODS	Academic cancer center and urban , private oncology offices .
METHODS	48 women with breast cancer who were in their mid-50s , married , and employed at the time of the study .
METHODS	Women were assigned to either the six-week TIP-C or attentional usual care groups .
METHODS	Women were matched on stage and treatment .
METHODS	Data were collected at baseline , after the six interventions , and one month postintervention .
METHODS	Measures included the Center for Epidemiologic Studies Depression Scale , Positive and Negative Affect Schedule , Multidimensional Fatigue Inventory , and Index of Clinical Stress .
METHODS	Depression , positive and negative affect , fatigue , and stress .
RESULTS	Women in the intervention group experienced decreases in depression , fatigue , and stress over time and increases in positive affect .
CONCLUSIONS	The preliminary results partially supported the effectiveness of TIP-C for symptom management and quality of life .
CONCLUSIONS	The authors hypothesized that decreased depression , reduced negative affect , decreased stress , decreased fatigue , and increased positive affect over time would be the resulting psychosocial effects , given the theoretical underpinnings of the intervention .
CONCLUSIONS	Nurses need to assess the quantity and quality of the social support network early in treatment ; women with less social support need to be referred to counseling and support services .
CONCLUSIONS	Because these women have limited participation in face-to-face interventions , they should be encouraged to participate in telephone or online support programs or in other programs or organizations ( e.g. , churches , social clubs ) that would provide support .

###22687392
OBJECTIVE	This study examined the effects of modafinil on apathetic symptomatology , performance of activities of daily living ( ADLs ) , and caregiver burden in individuals with Alzheimer 's disease ( AD ) .
METHODS	23 participants with a diagnosis of mild-to-moderate probable AD according to National Institute of Neurologic and Communicative Disorder and Stroke-Alzheimer 's Disease and Related Disorders criteria were randomized into the experimental ( modafinil 200 mg daily ) or control ( placebo ) groups .
METHODS	All participants were also receiving stable doses of a cholinesterase inhibitor medication .
METHODS	Participants completed assessments at baseline and after 8 weeks of treatment .
METHODS	Outcome measures included family report measures of apathy , ADL performance , and caregiver burden , as well as direct assessment of ADL performance .
METHODS	The study was conducted at a private psychiatric hospital in Rhode Island from September 2005 until September 2007 .
RESULTS	Both the experimental and control groups showed reductions in apathy on the Frontal Systems Behavior Scale between baseline and final assessments ( F1 ,20 = 18.017 , P < .001 , 2 = 0.474 ) , and there was no significant additional reduction in apathy with modafinil ( F1 ,20 = 0.008 , P = .932 , 2 = 0.000 ) .
RESULTS	Groups did not show significant changes in caregiver report of ADL performance over time ( F1 ,19 = 0.268 , P = .611 ) .
RESULTS	The correlation between change in apathy and change in caregiver burden was not significant ( r = 0.355 , P = .053 ) , but there was a trend toward improved levels of apathy being related to decreased levels of caregiver burden .
CONCLUSIONS	The addition of modafinil to the standard of care treatment ( cholinesterase inhibitor medication ) did not result in significant additional reductions in apathy or improvements in ADL functioning .
CONCLUSIONS	The reduction in reported apathy observed in both groups between baseline and final assessments was likely due to placebo effect .
CONCLUSIONS	However , reductions in perceived apathetic symptomatology were correlated with reductions in reported caregiver distress and burden .
CONCLUSIONS	Larger studies with more statistical power are needed to confirm the absence of significant effects .
BACKGROUND	ClinicalTrials.gov identifier : NCT01172145 .

###11136274
BACKGROUND	Prophylactic misoprostol or non-steroidal anti-inflammatory drugs ( NSAIDs ) with low gastric toxicity ( nabumetone ) has been shown to reduce mucosal injury .
OBJECTIVE	To compare nabumetone vs. co-therapy of naproxen with low-dose misoprostol for secondary prevention of upper gastrointestinal bleeding in NSAID users .
METHODS	NSAID users presenting with upper gastrointestinal bleeding were enrolled if they required long-term NSAIDs .
METHODS	After ulcer healing , they were randomized to receive : naproxen ( 500-1000 mg/day ) and misoprostol ( 200 microg b.d. ) , or nabumetone ( 1000-1500 mg/day ) and placebo misoprostol for 24 weeks .
METHODS	The primary end-point was recurrent upper gastrointestinal bleeding .
METHODS	The secondary end-point was the proportion of patients suffering from major gastrointestinal events including ulcer bleeding , symptomatic ulcers and severe dyspepsia .
RESULTS	A total of 90 patients were included in the intention-to-treat analysis ( misoprostol/naproxen 45 , nabumetone 45 ) .
RESULTS	Recurrent bleeding occurred in 10 patients ( 22.2 % ) receiving misoprostol/naproxen compared with three ( 6.7 % ) receiving nabumetone ( relative risk 3.33 , 95 % CI : 0.98-11 .32 , P = 0.069 ) .
RESULTS	The proportion of patients suffering from major gastrointestinal events at 24 weeks was 31.1 % in the misoprostol/naproxen group and 28.9 % in the nabumetone group .
CONCLUSIONS	Misoprostol/naproxen is not superior to nabumetone for secondary prevention of upper gastrointestinal bleeding .
CONCLUSIONS	Neither low-dose misoprostol nor nabumetone is adequate for high-risk NSAID users .

###15076638
BACKGROUND	Montelukast , a competitive cysteinyl leucotriene-1 receptor antagonist , reduces airway eosinophilia in asthmatics .
BACKGROUND	We evaluated the effect of this drug in children with eosinophilic duodenitis , defined histologically as duodenal mucosa with peak eosinophil count of more than 10 eosinophils/hpf .
METHODS	Forty children and adolescents ( 6-18 yr ) with dyspepsia and duodenal eosinophilia were enrolled in a double blind , randomized , placebo-controlled , cross-over study of monteleukast therapy .
METHODS	Subjects were randomized to receive either 10 mg montelukast or an identical placebo once daily and were evaluated on day 14 for symptomatic and biochemical responses .
METHODS	Subjects were also randomized to one of two blood sampling schemes to evaluate montelukast pharmacokinetics .
RESULTS	Using a post treatment global pain assessment , a positive clinical response was observed in 62.1 % of patients receiving montelukast compared with 32.4 % on placebo ( p < 0.02 ) .
RESULTS	Pain assessment score deteriorated in 45 % of montelukast responders ( 5/11 ) after cross-over to placebo and improved in 62 % ( 8/13 ) of placebo non-responders on cross-over to montelukast .
RESULTS	In patients with peak duodenal eosinophil counts between 20-29 / hpf ( n = 19 ) , a positive pain assessment response was observed in 84 % of patients receiving montelukast compared to 42 % receiving placebo ( p < 0.01 ) .
RESULTS	Response rate did not differ by age , gender or histologic findings at baseline .
RESULTS	Pharmacokinetic analysis yielded parameter estimates for absorption rate constant ( Ka ) , apparent volume of distribution ( Vd/F ) and elimination rate constant ( Kel ) of 0.42 h , 0.19 L/kg and 0.26 h , respectively .
RESULTS	The relative extent of systemic drug exposure was comparable to that observed in previous pediatric investigations with similar weight-adjusted montelukast doses .
RESULTS	Neither dose nor calculated drug exposure were associated with the level of post treatment pain assessment or the change in biochemical markers .
CONCLUSIONS	These data suggest a beneficial role for montelukast in the treatment of pediatric patients with dyspepsia associated with duodenal eosinophilia .

###10433527
OBJECTIVE	To compare re-epithelialization rates of superficial partial-thickness burns treated with octylcyanoacrylate ( OCA ) , silver sulfadiazine ( SSD ) , and dry gauze ( controls ) in swine .
METHODS	This was a prospective , longitudinal , blinded , controlled , experimental trial using anesthetized swine .
METHODS	Sixty-three standardized burns were created by applying an aluminum bar preheated to 80 degrees C for 20 seconds to the flanks of four young pigs .
METHODS	Three equal sets of 21 burns were randomly treated with OCA spray , SSD , or dry gauze ( controls ) .
METHODS	Full-thickness biopsies were taken after 30 minutes and at seven and 14 days for blinded histopathologic evaluation by two dermatopathologists using hematoxylin and eosin staining .
METHODS	The percent of wound re-epithelialization was measured at days 7 and 14 , calculated by dividing the length of the regenerated epidermis by the measured width of the biopsy .
METHODS	Analysis of variance ( ANOVA ) and repeated-measures ANOVA controlling for the individual pig were used for comparisons among groups .
METHODS	This study had 80 % power to demonstrate a large between-group difference in percent re-epithelization ( alpha = 0.05 ) .
RESULTS	There were 63 burns and 126 biopsies .
RESULTS	Ten biopsies were excluded for technical reasons .
RESULTS	At seven days , there was a significant between-group difference in percent re-epithelialization .
RESULTS	Percent re-epithelialization was greatest in the OCA group ( 65.0 % ) , followed by the SSD group ( 37.6 % ) , and lowest in the control group ( 8.8 % ) .
RESULTS	At 14 days , all wounds demonstrated near complete re-epithelialization and there was no significant difference in the percent of re-epithelialization among the groups .
RESULTS	There was only one wound infection in the OCA group .
CONCLUSIONS	Under these study conditions , treatment of partial-thickness burns with OCA spray resulted in a higher percent of re-epithelialization at seven but not 14 days when compared with both SSD and control , with no significant increase in infection rates .
CONCLUSIONS	Future studies should evaluate the use of OCA for the treatment of burns in humans .

###14516798
OBJECTIVE	To investigate whether conjunctival inflammation represents a primary event in the pathogenesis of keratoconjunctivitis sicca or whether it is a secondary inflammatory reaction caused by enhanced mechanical irritation as a result of surface dryness and whether anti-inflammatory drops ( corticosteroids and nonsteroidal anti-inflammatory ) have therapeutic effects and are similar .
METHODS	Single-masked , randomized , prospective clinical trial .
METHODS	Thirty-two keratoconjuctivitis patients with or without Sjgren syndrome were included in the study .
METHODS	The patients were randomized to three groups .
METHODS	Group 1 patients received a topical artificial tear substitute ( ATS ) ; group 2 received ATS plus nonsteroidal anti-inflammatory drops ( NSAID ) ; and group 3 received ATS plus topical corticosteroidal drops .
METHODS	The eye symptom severity scores , Schirmer test values , rose bengal and fluorescein staining scores were evaluated before treatment and 15 and 30 days after start of treatment .
METHODS	Impression cytology specimens were stained using immunohistochemical methods to detect the percentages of human leukocyte antigen II ( HLA-DR ) positive , Apo 2.7 positive , and periodic acid-Schiff positive cells .
METHODS	Statistical analyses were performed within and between groups .
METHODS	Group 3 patients had significantly lower symptom severity scores , fluorescein and rose bengal staining , and HLA-DR positive cells on days 15 and 30 compared with patients in other groups .
METHODS	They also had a significantly higher number of periodic acid-Schiff positive ( goblet ) cells in their impression cytology specimens on days 15 and 30 compared with the other patients .
METHODS	On day 30 , group 3 patients had significant differences compared with their baseline measurements in terms of above-mentioned parameters .
METHODS	However , we did not detect a significant effect of any treatment schedule on the Shirmer test value and the numbers of Apo 2.7 cells in impression cytology specimens .
CONCLUSIONS	Topical corticosteroids had a clearly beneficial effect both on the subjective and objective clinical parameters of moderate-to-severe dry eye patients .
CONCLUSIONS	These effects were associated with the reduction of inflammation markers of conjunctival epithelial cells .

###24284971
OBJECTIVE	To analyze the differences between biodegradable and nondegradable nasal dressings with regard to their effects on wound healing in the short and medium term and on surgical outcomes in the long term , after endoscopic sinus surgery ( ESS ) .
METHODS	A prospective , randomized , partly blinded , controlled trial .
METHODS	A total of 56 patients undergoing bilateral ESS for chronic rhinosinusitis with polyposis were enrolled and randomized to receive biodegradable ( Nasopore ; Stryker , Hamilton , ON , Canada ) on one side and nondegradable packing ( Merocel ; Medtronic Xomed , Minneapolis , MN ) on the opposite side .
METHODS	Postoperative morbidities ( pain , bleeding , facial edema , nasal blockage ) related to dressings were assessed on postoperative day 6 .
METHODS	Wound healing ( edema , crusting , secretions , synechia , granulation tissue formation , and percentage re-epithelialization ) were evaluated at 2 weeks , 1 month , 3 months , and 6 months using modified Lund-Kennedy scores .
METHODS	Long-term assessment at 12 months was done using validated Lund-Kennedy scores .
RESULTS	Morbidities related to nondegradable packing were significantly higher than with degradable packing ( Wilcoxon signed rank test , P < .01 ) .
RESULTS	Pain , bleeding , nasal blockage , and facial edema were significantly less with absorbable packing .
RESULTS	No statistically significant difference was found between sinonasal cavities packed with biodegradable or nondegradable materials with regard to healing scores and percentage of re-epithelialization at 2 weeks , 1 month , 3 months , 6 months , and surgical outcomes at 1 year ( P > .05 ) .
RESULTS	However , healing at 6 months was correlated with the preoperative Lund-Mackay radiology and surgery scores ( Spearman 's rho correlation test , P < .05 and P < .01 , respectively ) .
CONCLUSIONS	No significant healing or surgical outcome differences were found between biodegradable and nondegradable packing .
CONCLUSIONS	However pain , bleeding , nasal blockage , and facial edema were lower with biodegradable packing .
METHODS	1b .

###16500952
BACKGROUND	As xenon anaesthesia ( XE ) does not produce haemodynamic depression its use may be of benefit in patients at high risk of intraoperative haemodynamic instability and perioperative cardiac complications .
BACKGROUND	XE ( n = 22 ) was compared with total i.v. anaesthesia ( TIVA , n = 22 ) for differences in autonomic regulation , peri - and postoperative performance .
METHODS	Patients undergoing abdominal aortic surgery were studied at five events : T1 : baseline awake ; T2 : anaesthesia induction ; T3 : before aortic cross-clamping ; T4 : after aortic cross-clamping ; T5 : after aortic declamping .
METHODS	T3-T5 : end-tidal xenon concentration 60 ( 5 ) % .
METHODS	Intraoperative analysis : heart rate , heart rate variability , blood pressure and cardiac output .
METHODS	Postoperative analysis : 24 h Holter ECG , intensive care unit and hospital stay , and patient 's outcome after 6 months .
RESULTS	XE in contrast to TIVA increased parasympathetic and decreased sympathetic activity .
RESULTS	Median low to high frequency decreased significantly in the XE group after start of XE ( P < 0.05 ) and remained significantly lower during all events after start of XE as compared with TIVA ( P = 0.0001 ) .
RESULTS	After start of XE heart rate of these patients was significantly lower as compared with TIVA ( P = 0.04 ) .
RESULTS	Cardiac output increased significantly in TIVA after aortic declamping ( P < 0.05 ) .
RESULTS	Outcome parameters did not differ significantly between groups .
CONCLUSIONS	XE patients demonstrated lower sympathetic and higher parasympathetic activity as compared with TIVA patients .
CONCLUSIONS	This was reflected by significant differences in haemodynamics but did not correlate with a better postoperative outcome .
CONCLUSIONS	Thus , it remains controversial whether XE provides benefits in high risk patients .

###21079179
BACKGROUND	Excessive daytime sleepiness ( EDS ) and fatigue are common symptoms after traumatic brain injury ( TBI ) , but there is no specific treatment for affected patients .
BACKGROUND	With this pilot study , we aimed at studying the effect of daily modafinil on posttraumatic EDS and fatigue .
METHODS	We conducted a prospective , double-blind , randomized , placebo-controlled pilot study in 20 patients with TBI who had fatigue or EDS or both .
METHODS	After baseline examinations ( questionnaires including the Epworth Sleepiness Scale to assess EDS and the Fatigue Severity Scale to assess fatigue , actigraphy , polysomnography , maintenance of wakefulness test , and psychomotor vigilance test ) , 10 patients received 100 to 200 mg modafinil every morning , and 10 patients were treated with placebo .
METHODS	After a 6-week treatment period , all examinations were repeated .
RESULTS	EDS improved significantly in patients with TBI who were treated with modafinil , compared with the placebo group .
RESULTS	Similarly , the ability to stay awake on the maintenance of wakefulness test improved only in the modafinil group .
RESULTS	Modafinil , however , had no impact on posttraumatic fatigue .
RESULTS	Clinically relevant side effects were not observed .
CONCLUSIONS	This study indicates that modafinil is effective and well tolerated in the treatment of posttraumatic EDS but not of fatigue .
METHODS	This study provides Class I evidence that modafinil ( 100-200 mg daily ) improves posttraumatic EDS compared with placebo .
METHODS	This study provides Class I evidence that modafinil ( 100-200 mg daily ) does not improve posttraumatic fatigue compared with placebo .

###18580415
OBJECTIVE	To determine whether various intensities of aerobic training differentially affect aerobic capacity as well as resting HR and resting blood pressure ( BP ) .
METHODS	Sixty-one health young adult subjects were matched for sex and VO2max and were randomly assigned to a moderate - ( 50 % VO2 reserve ( VO2R ) , vigorous ( 75 % VO2R ) , near-maximal-intensity ( 95 % VO2R ) , or a nonexercising control group .
METHODS	Intensity during exercise was controlled by having the subjects maintain target HR based on HR reserve .
METHODS	Exercise volume ( and thus energy expenditure ) was controlled across the three training groups by varying duration and frequency .
METHODS	Fifty-five subjects completed a 6-wk training protocol on a stationary bicycle ergometer and pre - and posttesting .
METHODS	During the final 4 wk , the moderate-intensity group exercised for 60 min , 4 d.wk the vigorous-intensity group exercised for 40 min , 4 d.wk and the near-maximal-intensity group exercised 3 d.wk performing 5 min at 75 % VO2R followed by five intervals of 5 min at 95 % VO2R and 5 min at 50 % VO2R .
RESULTS	VO2max significantly increased in all exercising groups by 7.2 , 4.8 , and 3.4 mL.min.kg in the near-maximal - , the vigorous - , and the moderate-intensity groups , respectively .
RESULTS	Percent increases in the near-maximal - ( 20.6 % ) , the vigorous - ( 14.3 % ) , and the moderate-intensity ( 10.0 % ) groups were all significantly different from each other ( P < 0.05 ) .
RESULTS	There were no significant changes in resting HR and BP in any group .
CONCLUSIONS	When volume of exercise is controlled , higher intensities of exercise are more effective for improving VO2max than lower intensities of exercise in healthy , young adults .

###25052161
BACKGROUND	Psoriasis causes worldwide concern because of its high-prevalence , as well as its harmful , and incurable characteristics .
BACKGROUND	Topical therapy is a conventional treatment for psoriasis vulgaris .
BACKGROUND	Chinese medicine ( CM ) has been commonly used in an integrative way for psoriasis patients for many years .
BACKGROUND	Some CM therapies have shown therapeutic effects for psoriasis vulgaris ( PV ) , including relieving symptoms and improving quality of life , and may reduce the relapse rate .
BACKGROUND	However , explicit evidence has not yet been obtained .
BACKGROUND	The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule , a compound Chinese herbal medicine , with a combination of topical therapy for PV patients .
METHODS	Using an add-on design , the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV .
METHODS	The study design is a double-blind , parallel , randomized controlled trial comparing the YXBCM01 granule ( 5.5 g twice daily ) to a placebo .
METHODS	The duration of treatment is 12weeks .
METHODS	A total of 600 participants will be randomly allocated into two groups , YXBCM01 granule group and placebo group , from 11 general or dermatological hospitals in China .
METHODS	Topical use of calcipotriol betamethasone for the first 4weeks and calcipotriol ointment for the remaining 8weeks will be the same standard therapy for the two groups .
METHODS	Patients will be enrolled if they have a clinical diagnosis of PV , a psoriasis area severe index ( PASI ) of more than 10 or body surface area ( BSA ) of more than 10 % , but PASI of less than 30 and BSA of less than 30 % , are aged between 18 and 65-years-old , and provide signed informed consent .
METHODS	The primary outcome , relapse rate , is based on PASI assessed blindly during the treatment .
METHODS	Secondary outcomes include : ( i ) relapse time interval , ( ii ) time to onset , ( iii ) rebound rate , ( iv ) PASI score , ( v ) cumulative consumption of medicine , ( vi ) the dermatology quality life index ( DLQI ) , and ( vii ) the medical outcomes study ( MOS ) item short form health survey ( SF-36 ) .
METHODS	Analysis will be on intention-to-treat and per-protocol subject analysis principles .
CONCLUSIONS	To address the effectual remission of the YXBCM01 granule for PV , this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects .
BACKGROUND	Chinese Clinical Trial Registry ( http://cwww.chictr.org ) : ChiCTR-TRC-13003233 , registered 26 May 2013 .

###23587135
BACKGROUND	Flight simulators have been used to train pilots to experience and recognize spatial disorientation , a condition in which pilots incorrectly perceive the position , location , and movement of their aircrafts .
BACKGROUND	However , during or after simulator training , simulator sickness ( SS ) may develop .
BACKGROUND	Spatial disorientation and SS share common symptoms and signs and may involve a similar mechanism of dys-synchronization of neural inputs from the vestibular , visual , and proprioceptive systems .
BACKGROUND	Transcutaneous electrical nerve stimulation ( TENS ) , a maneuver used for pain control , was found to influence autonomic cardiovascular responses and enhance visuospatial abilities , postural control , and cognitive function .
BACKGROUND	The purpose of present study was to investigate the protective effects of TENS on SS .
METHODS	Fifteen healthy young men ( age : 28.60.9 years , height : 172.51.4 cm , body weight : 69.31.3 kg , body mass index : 23.41.8 kg/m2 ) participated in this within-subject crossover study .
METHODS	SS was induced by a flight simulator .
METHODS	TENS treatment involved 30 minutes simultaneous electrical stimulation of the posterior neck and the right Zusanli acupoint .
METHODS	Each subject completed 4 sessions ( control , SS , TENS , and TENS+SS ) in a randomized order .
METHODS	Outcome indicators included SS symptom severity and cognitive function , evaluated with the Simulator Sickness Questionnaire ( SSQ ) and d2 test of attention , respectively .
METHODS	Sleepiness was rated using the Visual Analogue Scales for Sleepiness Symptoms ( VAS-SS ) .
METHODS	Autonomic and stress responses were evaluated by heart rate , heart rate variability ( HRV ) and salivary stress biomarkers ( salivary alpha-amylase activity and salivary cortisol concentration ) .
RESULTS	Simulator exposure increased SS symptoms ( SSQ and VAS-SS scores ) and decreased the task response speed and concentration .
RESULTS	The heart rate , salivary stress biomarker levels , and the sympathetic parameter of HRV increased with simulator exposure , but parasympathetic parameters decreased ( p < 0.05 ) .
RESULTS	After TENS treatment , SS symptom severity significantly decreased and the subjects were more able to concentrate and made fewer cognitive test errors ( p < 0.05 ) .
CONCLUSIONS	Sympathetic activity increased and parasympathetic activity decreased after simulator exposure .
CONCLUSIONS	TENS was effective in reducing SS symptoms and alleviating cognitive impairment .
BACKGROUND	Australia and New Zealand Clinical Trials Register : http://ACTRN12612001172897 .

###17697104
OBJECTIVE	To evaluate the effect of epoetin alfa treatment on hemoglobin ( Hb ) , fatigue , quality of life ( QOL ) , and mobility in elderly patients with chronic anemia .
METHODS	An exploratory , 32 week , randomized , double-blind , crossover treatment trial .
METHODS	Sixty-two community-dwelling individuals aged 65 and older with chronic anemia ( Hb < or = 11.5 g/dL ) .
METHODS	Subcutaneous epoetin alfa or placebo weekly for 16 weeks ( Phase I ) with crossover to the opposite treatment ( Phase II ) .
METHODS	Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy ( FACIT ) measurement system .
METHODS	Mobility was assessed as a secondary outcome using the Timed Up and Go ( TUG ) test .
RESULTS	Of the 62 subjects enrolled , complete data were analyzed for 58 in Phase I and 54 participants in Phase II .
RESULTS	Of those enrolled , most were African American ( 95 % ) and female ( 85 % ) and had multiple comorbidities and a mean age + / - standard deviation of 76.1 + / -7.2 .
RESULTS	Mean baseline Hb was 10.5 + / -0.9 g/dL ( 7.3-11 .5 ) .
RESULTS	In Phase I , 67 % of those taking epoetin alfa , and in Phase II , 69 % of those taking epoetin alfa had an increase in Hb of more than 2 g/dL , significantly more than those taking placebo ( P < .001 ) .
RESULTS	Similarly , elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases ( all P < .05 ) .
RESULTS	No significant differences were found between treatment and placebo on TUG scores .
RESULTS	Epoetin alfa was well tolerated .
CONCLUSIONS	In this trial involving predominantly older African-American women with anemia , a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL .

###15140778
BACKGROUND	Diary recording of pain and disabling activities in osteoarthritis ( OA ) is widely recommended , but , to our knowledge , its impact on symptoms has not been investigated .
BACKGROUND	Exercise programmes have been shown to be effective when patients are closely supervised by nurses or physiotherapists ; however , data are lacking on the efficacy of an unsupervised home based exercise regimen in patients with OA .
OBJECTIVE	To evaluate the clinical efficacy of patient administered assessment tools and an unsupervised home based exercise programme alone or in combination in patients with OA .
METHODS	The study was a 24 week , open cluster randomised controlled trial with a factorial design .
METHODS	Rheumatologists ( n = 867 ) were assigned to four groups according to the treatment given : standardised tools ( ST ; n = 220 ) , exercises ( EX ; n = 213 ) , both tools and exercises ( ST+EX ; n = 213 ) , or usual care ( n = 221 ) .
METHODS	Each rheumatologist was to enroll four patients who met the American College of Rheumatology criteria for OA ( three with knee OA , one with hip OA ) .
METHODS	`` Tools '' consisted of weekly recording of pain and disabling activities in a diary .
METHODS	A home based exercise programme was performed daily at least four times per week with the aid of videotape and booklet .
METHODS	In addition to exercise and assessment , all patients received 12.5 mg or 25 mg of the non-steroidal anti-inflammatory drug rofecoxib once daily .
METHODS	Outcome variables were : pain ( measured on a visual analogue scale , 0-100 ) ; Western Ontario and McMaster Universities Osteoarthritis Index , function subscale ( 0-100 ) ; and patient assessment of the quality of care ( 0-100 ) .
RESULTS	Overall , 2957 patients with OA ( 2216 knee , 741 hip ) were included .
RESULTS	After 24 weeks , both pain and function improved in the ST , EX , ST+EX , and usual care groups ( mean ( SD ) -17 ( 27 ) , -20 ( 29 ) , -15 ( 27 ) , -19 ( 29 ) ; and -11 ( 19 ) , -12 ( 19 ) , -10 ( 19 ) , -11 ( 20 ) , respectively ) , without significant differences between groups .
RESULTS	However , patients in the EX and ST+EX groups were more likely to agree that their rheumatologist had done his best to preserve their functional and physical activities .
CONCLUSIONS	Although patients ' assessments favoured the exercise programme , results from this study failed to demonstrate a short term symptomatic effect of the two non-pharmacological treatments ( weekly recording of condition and exercise ) in patients with OA concurrently receiving nonsteroidal anti-inflammatory drugs .

###21840651
BACKGROUND	Some chronic pain patients on long-term opioid therapy also take centrally active skeletal muscle relaxants .
BACKGROUND	One of those muscle relaxants is carisoprodol , a drug that is abused and capable of producing impairment .
BACKGROUND	It would be of relevance to characterize the effects of an opioid and carisoprodol when taken together to determine if abuse liability-related measures and psychomotor impairment are increased compared to when the drugs are taken alone .
METHODS	As part of a larger crossover , randomized , double-blind study , we examined the subjective and psychomotor responses of 15 healthy volunteers to four experimental conditions : placebo , 350 mg carisoprodol , 10mg oxycodone , and 350 mg carisoprodol followed 60 min later by 10mg oxycodone ( intended to test the interaction of the two drugs when they were producing their maximal effects ) .
RESULTS	Preliminary data analyses indicated that some of carisoprodol 's effects were declining when we tested for drug interactions .
RESULTS	Despite this , on some outcome measures in which the drugs alone did not differ from placebo , when tested together subjective effects were increased , including those that were abuse liability-related , and psychomotor performance decreased , relative to placebo .
CONCLUSIONS	This is the first study that we are aware of that has shown that carisoprodol and oxycodone , two drugs that are sometimes co-prescribed for relief of pain , produce effects when administered `` together '' ( i.e. , separated by 60 min ) that are of greater magnitude than when they are administered alone .
CONCLUSIONS	Some of the effects were not benign , and are of concern from both abuse liability and public safety standpoints .

###19717691
BACKGROUND	Spirometry for early detection of chronic obstructive pulmonary disease ( COPD ) and smoking cessation is criticised because of the potential negative effects of labelling with disease .
OBJECTIVE	To assess the effects of opinions of smokers with mild to moderate COPD on the effectiveness of spirometry for smoking cessation , the justification of early detection of airflow limitation in smokers and the impact of confrontation with COPD .
METHODS	Qualitative study with data from a randomised controlled trial .
METHODS	General population of Dutch and Belgian Limburg .
METHODS	Semistructured ethical exit interviews were conducted with 205 smokers who were motivated to quit smoking and had no prior diagnosis of COPD but were detected with airflows limitation by means of spirometry .
METHODS	They received either ( 1 ) counselling , including labelling with COPD , plus with nortriptyline for smoking cessation , ( 2 ) counselling excluding labelling with COPD , plus nortriptyline for smoking cessation or ( 3 ) care as usual for smoking cessation by the general practitioner , without labelling with COPD .
RESULTS	Of the participants , 177 ( 86 % ) agreed or completely agreed that it is justified to measure lung function in heavy smokers .
RESULTS	These participants argued that measuring lung function raises consciousness of the negative effects of smoking , helps to prevent disease or increases motivation to stop smoking .
RESULTS	Most of the 18 participants who disagreed argued that routinely measuring lung function in smokers would interfere with freedom of choice .
CONCLUSIONS	Labelling with disease is probably a less important issue in the discussion about the pros and cons of early detection of COPD .

###17275886
BACKGROUND	A state of hypercoagulation and fibrinolytic dysfunction is present in individuals with diabetes , which may contribute to disturbed skin microcirculation and impaired ulcer healing .
BACKGROUND	We have previously reported an improved outcome of chronic diabetic foot ulcers during treatment with dalteparin .
BACKGROUND	In the present study we investigated the effects of dalteparin on skin microcirculation and haemostatic function .
METHODS	87 patients with diabetes , peripheral arterial obliterative disease and chronic foot ulcers were investigated in a prospective , randomised , double-blind and placebo-controlled study .
METHODS	They were randomised to treatment with subcutaneous injections of 5000 U dalteparin ( n = 44 ) or placebo ( n = 43 ) , once daily until ulcer healing or for a maximum of six months .
METHODS	Plasma fibrinogen , fibrin gel structure [ permeability coefficient ( Ks ) and fiber mass/length ratio ( mu ) ] , prothrombin fragment 1 +2 ( F1 +2 ) antigen , plasminogen activator inhibitor-1 ( PAI-1 ) activity and tissue plasminogen activator ( tPA ) antigen were analysed before randomization ( baseline value ) , and at the end of the treatment period .
METHODS	The skin microcirculation of the foot was investigated by transcutaneous oxygen tension ( TcPO ( 2 ) ) and laser Doppler fluxmetry ( LDF ) .
RESULTS	The changes ( Delta-values ) of Ks , mu , tPA and TcPO ( 2 ) were higher ( p < 0.05 ) during treatment with dalteparin , as compared to the changes during treatment with placebo .
RESULTS	At baseline , plasma fibrinogen and Ks were significantly correlated to TcPO ( 2 ) .
CONCLUSIONS	Local skin oxygenation improved and a less thrombogenic fibrin gel structure was formed in patients treated with dalteparin .
CONCLUSIONS	Beneficial effects on haemostatic function are likely to contribute to the improved skin oxygenation observed during treatment with dalteparin .

###15890074
BACKGROUND	Training of a repetitive synchronised movement of two limb muscles leads to short-term plastic changes in the primary motor cortex , which can be assessed by transcranial magnetic stimulation ( TMS ) mapping .
BACKGROUND	We used this paradigm to study the effect of memantine , a NDMA antagonist , on short-term motor cortex plasticity in 20 healthy human subjects , and we were especially interested in possible differential effects of different treatment regimens .
BACKGROUND	In a randomised double-blinded cross over study design we therefore administered placebo or memantine either as a single dosage or as an ascending dosage over 8 days .
BACKGROUND	Before and after one hour of motor training , which consisted of a repetitive co-contraction of the abductor pollicis brevis ( APB ) and the deltoid muscle , we assessed the motor output map of the APB muscle by TMS under the different conditions .
RESULTS	We found a significant medial shift of the APB motor output map after training in the placebo condition , indicating training-induced short-term plastic changes in the motor cortex .
RESULTS	A single dosage of memantine had no significant effect on this training-induced plasticity , whereas memantine administered in an ascending dosage over 8 days was able to block the cortical effect of the motor training .
RESULTS	The memantine serum levels after 8 days were markedly higher than the serum levels after a single dosage of memantine , but there was no individual correlation between the shift of the motor output map and the memantine serum level .
RESULTS	Besides , repeated administration of a low memantine dosage also led to an effective blockade of training-induced cortical plasticity in spite of serum levels comparable to those reached after single dose administration , suggesting that the repeated administration was more important for the blocking effect than the memantine serum levels .
CONCLUSIONS	We conclude that the NMDA-antagonist memantine is able to block training-induced motor cortex plasticity when administered over 8 days , but not after administration of a single dose .
CONCLUSIONS	This differential effect might be mainly due to the prolonged action of memantine at the NMDA receptor .
CONCLUSIONS	These findings must be considered if clinical studies are designed , which aim at evaluating the potency of memantine to prevent `` maladaptive '' plasticity , e.g. after limb amputation .

###25201555
OBJECTIVE	Application of an abdominal binder is often part of a standard postoperative regimen after ventral hernia repair to reduce pain and seroma formation .
OBJECTIVE	However , there is lack of evidence of the clinical effects .
OBJECTIVE	The aim of the present study was to investigate the pain - and seroma-reducing effect of an abdominal binder in patients undergoing laparoscopic umbilical or epigastric hernia repair .
METHODS	Based on power analysis , a minimum of 54 patients undergoing laparoscopic umbilical and epigastric hernia repair were to be included .
METHODS	Patients were randomized to abdominal binders vs. no abdominal binders during the first postoperative week .
METHODS	Standardized surgical technique , anaesthesia , and analgesic regimens were used and study observers were blinded towards the intervention .
METHODS	Postoperative pain ( visual analogue score ) on day 1 was the primary outcome .
METHODS	In addition , ultrasonographic evaluation of seroma formation and several subjective patient-related parameters were registered .
METHODS	Furthermore , patients in the abdominal binder group were asked to rate benefits or discomforts of wearing the binder .
RESULTS	Data from 56 patients ( abdominal binder , n = 28 ; no binder , n = 28 ) were available for analysis .
RESULTS	No significant intergroup differences in postoperative pain or any of the other surgical outcomes , including seroma formation , were found .
RESULTS	However , the abdominal binder group reported subjective beneficial effect of wearing the binder in 24 of the 28 patients ( 86 % ) .
RESULTS	No adverse effects of the abdominal binder were found .
CONCLUSIONS	There were no effects of an abdominal binder on pain , movement limitation , fatigue , seroma formation , general well-being , or quality of life .
CONCLUSIONS	However , most patients claimed a subjective beneficial effect of using their abdominal binder .

###19724042
BACKGROUND	Chronic pelvic pain is a common condition with a major effect on health-related quality of life , work productivity , and health care use .
BACKGROUND	Operative interruption of nerve trunks in the uterosacral ligaments by laparoscopic uterosacral nerve ablation ( LUNA ) is a treatment option for patients with chronic pelvic pain .
OBJECTIVE	To assess the effectiveness of LUNA in patients with chronic pelvic pain .
METHODS	Randomized controlled trial of 487 women with chronic pelvic pain lasting longer than 6 months without or with minimal endometriosis , adhesions , or pelvic inflammatory disease , who were recruited to the study by consultant gynecological surgeons from 18 UK hospitals between February 1998 and December 2005 .
METHODS	Follow-up was conducted by questionnaires mailed at 3 and 6 months and at 1 , 2 , 3 , and 5 years .
METHODS	Bilateral LUNA or laparoscopy without pelvic denervation ( no LUNA ) ; participants were blinded to the treatment allocation .
METHODS	The primary outcome was pain , which was assessed by a visual analogue scale .
METHODS	Data concerning the 3 types of pain ( noncyclical pain , dysmenorrhea , and dyspareunia ) were analyzed separately as was the worst pain level experienced from any of these 3 types of pain .
METHODS	The secondary outcome was health-related quality of life , which was measured using a generic instrument ( EuroQoL EQ-5D and EQ-VAS ) .
RESULTS	After a median follow-up of 69 months , there were no significant differences reported on the visual analogue pain scales for the worst pain ( mean difference between the LUNA group and the no LUNA group , -0.04 cm [ 95 % confidence interval { CI } , -0.33 to 0.25 cm ] ; P = .80 ) , noncyclical pain ( -0.11 cm [ 95 % CI , -0.50 to 0.29 cm ] ; P = .60 ) , dysmenorrhea ( -0.09 cm [ 95 % CI , -0.49 to 0.30 cm ] ; P = .60 ) , or dyspareunia ( 0.18 cm [ 95 % CI , -0.22 to 0.62 cm ] ; P = .40 ) .
RESULTS	No differences were observed between the LUNA group and the no LUNA group for quality of life .
CONCLUSIONS	Among women with chronic pelvic pain , LUNA did not result in improvements in pain , dysmenorrhea , dyspareunia , or quality of life compared with laparoscopy without pelvic denervation .
BACKGROUND	controlled-trials .
BACKGROUND	com Identifier : ISRCTN41196151 .

###16078955
OBJECTIVE	To determine the relative effects of cobblestone mat walking , in comparison with regular walking , on physical function and blood pressure in older adults .
METHODS	Randomized trial with allocation to cobblestone mat walking or conventional walking .
METHODS	General community in Eugene , Oregon .
METHODS	One hundred eight physically inactive community-dwelling adults aged 60 to 92 ( mean age + / - standard deviation = 77.5 + / -5.0 ) free of neurological and mobility-limiting orthopedic conditions .
METHODS	Participants were randomized to a cobblestone mat walking condition ( n = 54 ) or regular walking comparison condition ( n = 54 ) and participated in 60-minute group exercise sessions three times per week for 16 consecutive weeks .
METHODS	Primary endpoint measures were balance ( functional reach , static standing ) , physical performance ( chair stands , 50-foot walk , Up and Go ) , and blood pressure ( systolic , diastolic ) .
METHODS	Secondary endpoint measures were Short Form-12 physical and mental health scores and perceptions of health-related benefits from exercise .
RESULTS	At the 16-week posttest , differences between the two exercise groups were found for balance measures ( P = .01 ) , chair stands ( P < .001 ) , 50-foot walk ( P = .01 ) , and blood pressure ( P = .01 ) but not for the Up and Go test ( P = .14 ) .
RESULTS	Although significant within-group changes were observed in both groups for the secondary outcome measures , there were no differences between intervention groups .
CONCLUSIONS	Cobblestone mat walking improved physical function and reduced blood pressure to a greater extent than conventional walking in older adults .
CONCLUSIONS	Additional benefits of this walking program included improved health-related quality of life .
CONCLUSIONS	This new physical activity may provide a therapeutic and health-enhancing exercise alternative for older adults .

###18544384
OBJECTIVE	This prospective randomized double-blind study examined the effect of local wound infusion of anesthetics on pain control in the thoracotomy wound of patients undergoing minimally invasive cardiac surgery .
METHODS	Patients who underwent coronary artery bypass grafting or cardiac valvular procedures via a minimally invasive thoracotomy were studied .
METHODS	Patients were enrolled and randomly allocated to two groups with different modalities of postoperative analgesia .
METHODS	The thoracotomy wound infusion group received 0.15 % bupivacaine infused continuously at 2 mL/h through a catheter embedded in the wound , as well as intravenous patient-controlled analgesia .
METHODS	The control group had patient-controlled analgesia alone with a sham thoracotomy wound infusion of normal saline .
METHODS	Verbal analog pain scores ( 0-10 points ) and recovery profiles were investigated .
RESULTS	There were 19 patients in each group for complete data analysis .
RESULTS	On the first day after the operation , infusion of local anesthetics significantly reduced the verbal analog pain scores both at rest and during motion ( thoracotomy wound infusion vs control ) .
RESULTS	The improved pain relief with thoracotomy wound infusion persisted at day 3 and even at 3 months after the operation .
RESULTS	No difference was noted about time to extubation , length of intensive care unit stay , or hospital stay .
CONCLUSIONS	In this controlled double-blind study , thoracotomy wound infusion and patient-controlled analgesia were superior to patient-controlled analgesia alone in reducing pain at 1 , 3 , and 90 days after minimally invasive cardiac surgery .

###12842526
BACKGROUND	We evaluated the newly introduced Bioline heparin coating and tested the hypothesis that surface heparinization limited to the oxygenator and the arterial filter will ameliorate systemic inflammation and preserve platelets during cardiopulmonary bypass ( CPB ) .
METHODS	In a prospective double-blind study , 159 patients underwent coronary revascularization using closed-system CPB with systemic heparinization , mild hypothermia ( 33 degrees C ) , a hollow-fiber oxygenator , and an arterial filter .
METHODS	The patients were randomly divided in three groups .
METHODS	In group A ( controls , n = 51 ) , surface heparinization was not used .
METHODS	In group B ( n = 52 ) , the extracorporeal circuits were totally surface-heparinized with Bioline coating .
METHODS	In group C ( n = 56 ) , surface heparinization was limited to oxygenator and arterial filter .
RESULTS	No significant difference was noted in patient characteristics and operative data between groups .
RESULTS	Operative ( 30-day ) mortality was zero .
RESULTS	Platelet counts dropped by 12.3 % of pre-CPB value among controls at 15 minutes of CPB , but were preserved in groups B and C throughout perfusion ( p = 0.0127 ) .
RESULTS	Platelet factor 4 , plasmin-antiplasmin levels , and tumor necrosis factor-alpha increased more in controls during CPB than in groups B or C ( p = 0.0443 , p = 0.0238 and p = 0.0154 respectively ) .
RESULTS	Beta-thromboglobulin , fibrinopeptide-A , prothrombin fragments 1 + 2 , factor XIIa levels , bleeding times , blood loss , and transfusion requirements were similar between groups .
RESULTS	Intensive care unit stay was shorter in groups B and C than in controls ( p = 0.037 ) .
CONCLUSIONS	Surface heparinization with Bioline coating preserves platelets , ameliorates the inflammatory response and is associated with a reduced fibrinolytic activity during CPB .
CONCLUSIONS	Surface heparinization limited to the oxygenator and the arterial filter had similar results as totally surface-heparinized circuits .

###23234491
BACKGROUND	The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature .
BACKGROUND	Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia .
BACKGROUND	An example is virtual reality , which has been used effectively to dampen pain intensity and unpleasantness .
BACKGROUND	Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated .
BACKGROUND	The purpose of this study is to investigate these relationships , specifically by determining if a newly developed multi-modal procedural preparation and distraction device ( Ditto ) used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization .
METHODS	Children ( 4 to 12 years ) with acute burn injuries presenting for their first dressing change will be randomly assigned to either the ( 1 ) Control group ( standard distraction ) or ( 2 ) Ditto intervention group ( receiving Ditto , procedural preparation and Ditto distraction ) .
METHODS	It is intended that a minimum of 29 participants will be recruited for each treatment group .
METHODS	Repeated measures of pain intensity , anxiety , stress and healing will be taken at every dressing change until complete wound re-epithelialization .
METHODS	Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto intervention , as well as its effect on speed of wound re-epithelialization .
CONCLUSIONS	Results of this study will provide data on whether the disease process can be altered by reducing stress , pain and anxiety in the context of acute burn wounds .
BACKGROUND	ACTRN12611000913976 .

###20888994
BACKGROUND	On the basis of promising results that were reported in several phase 2 trials , we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia .
METHODS	Treatment-naive , physically fit patients ( aged 30-81 years ) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine ( 25 mg/m ( 2 ) per day ) and cyclophosphamide ( 250 mg/m ( 2 ) per day ) for the first 3 days of each 28-day treatment course with or without rituximab ( 375 mg/m ( 2 ) on day 0 of first course , and 500 mg/m ( 2 ) on day 1 of second to sixth courses ) in 190 centres in 11 countries .
METHODS	Investigators and patients were not masked to the computer-generated treatment assignment .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00281918 .
RESULTS	408 patients were assigned to fludarabine , cyclophosphamide , and rituximab ( chemoimmunotherapy group ) and 409 to fludarabine and cyclophosphamide ( chemotherapy group ) ; all patients were analysed .
RESULTS	At 3 years after randomisation , 65 % of patients in the chemoimmunotherapy group were free of progression compared with 45 % in the chemotherapy group ( hazard ratio 056 [ 95 % CI 046-069 ] , p < 00001 ) ; 87 % were alive versus 83 % , respectively ( 067 [ 048-092 ] ; p = 001 ) .
RESULTS	Chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia ( 136 [ 34 % ] of 404 vs 83 [ 21 % ] of 396 ; p < 00001 ) and leucocytopenia ( 97 [ 24 % ] vs 48 [ 12 % ] ; p < 00001 ) .
RESULTS	Other side-effects , including severe infections , were not increased .
RESULTS	There were eight ( 2 % ) treatment-related deaths in the chemoimmunotherapy group compared with ten ( 3 % ) in the chemotherapy group .
CONCLUSIONS	Chemoimmunotherapy with fludarabine , cyclophosphamide , and rituximab improves progression-free survival and overall survival in patients with chronic lymphocytic leukaemia .
CONCLUSIONS	Moreover , the results suggest that the choice of a specific first-line treatment changes the natural course of chronic lymphocytic leukaemia .
BACKGROUND	F Hoffmann-La Roche .

###11789186
OBJECTIVE	To explore the effect of Chinese drug Chang ` ai Kangfu decoction ( CAKF ) on immunity in post-operational patients with large intestine cancer ( LIC ) .
METHODS	Forty-eight patients with LIC in Dukes ' B , C stage after operation were randomly assigned to 3 groups , the CAKF group ( 16 cases ) , chemotherapy group ( 17 cases ) and combination therapy ( CAKF plus chemotherapy ) group ( 15 cases ) .
METHODS	5-FU and mitomycin C were given to the chemotherapy group .
METHODS	The dynamic changes of T-lymphocyte subsets , NK cells and immunoglobulins were investigated .
RESULTS	Before operation , the CD3 + , CD4 + , CD4 + / CD8 + and the activity of NK cells in LIC patients were lower , but CD8 + was higher than that of normal level ( P < 0.01 ) , which indicated that cellular immunity in LIC was in immunosuppressive state , they all further reduced 1 week after operation , particularly CD3 + cell counts , but CD3 + , CD4 + and the activity of NK cells normalized 1 month after operation in CAKF group , and 2 months were needed to normalize in combination therapy group .
RESULTS	Both groups recovered to a certain extent in comparing with before treatment , but the chemotherapy group recovered slower .
RESULTS	The similar results appeared in humoral immunity .
CONCLUSIONS	CAKF could obviously increase the immunity in LIC patients after operation .

###16458133
OBJECTIVE	We studied the modifier effect of platelet antigen polymorphism ( PlA2 ) on platelet inhibition by acetylsalicylic acid ( ASA , i.e. , aspirin ) , clopidogrel , or their combination in patients with coronary heart disease .
BACKGROUND	Clopidogrel , when administered with ASA , was shown to significantly improve the outcome of patients with acute coronary syndromes compared with patients receiving only ASA .
BACKGROUND	We have shown previously that the effect of ASA on platelets is modified by the glycoprotein IIIa single nucleotide polymorphism PlA2 .
BACKGROUND	Hence , an important pharmacogenetic question remains whether the antiplatelet effect of clopidogrel is uniform for all patients or , like acetylsalicylic acid , more selective .
METHODS	Thirty PlA1/A1 and 30 PlA1/A2 patients were assigned randomly to ASA 325 mg/day , clopidogrel 75 mg/day , or both .
METHODS	After 10 days , platelet function was studied .
RESULTS	Clopidogrel provided stronger platelet inhibition than ASA with adenosine diphosphate as the agonist , and combination therapy resulted in greater inhibition than either inhibitor used alone ( p < 0.0001 ) .
RESULTS	The use of ASA resulted in greater inhibition compared with clopidogrel with epinephrine ( p < 0.0001 ) and collagen as agonists ( p < 0.0001 ) .
RESULTS	With collagen as the agonist , platelets from PlA1/A2 donors were markedly and significantly less inhibited by ASA ( p = 0.005 ) .
RESULTS	In contrast , with clopidogrel , no significant difference could be detected between inhibition of Pl ( A1/A1 ) and Pl ( A1/A2 ) platelets .
CONCLUSIONS	The combination of ASA and clopidogrel appears superior to either agent alone in inhibiting platelet function .
CONCLUSIONS	Pl ( A2 ) functions as an important modifier for platelet responsiveness to ASA but not to clopidogrel .
CONCLUSIONS	These findings could have significant impact on the future design of pharmacogenetic antithrombotic strategies for patients with coronary heart disease .

###11297958
BACKGROUND	Reversal of the progressive increase in frequency of atopic disease would be an important breakthrough for health care and wellbeing in western societies .
BACKGROUND	In the hygiene hypothesis this increase is attributed to reduced microbial exposure in early life .
BACKGROUND	Probiotics are cultures of potentially beneficial bacteria of the healthy gut microflora .
BACKGROUND	We assessed the effect on atopic disease of Lactobacillus GG ( which is safe at an early age and effective in treatment of allergic inflammation and food allergy ) .
METHODS	In a double-blind , randomised placebo-controlled trial we gave Lactobacillus GG prenatally to mothers who had at least one first-degree relative ( or partner ) with atopic eczema , allergic rhinitis , or asthma , and postnatally for 6 months to their infants .
METHODS	Chronic recurring atopic eczema , which is the main sign of atopic disease in the first years of life , was the primary endpoint .
RESULTS	Atopic eczema was diagnosed in 46 of 132 ( 35 % ) children aged 2 years .
RESULTS	Asthma was diagnosed in six of these children and allergic rhinitis in one .
RESULTS	The frequency of atopic eczema in the probiotic group was half that of the placebo group ( 15/64 [ 23 % ] vs 31/68 [ 46 % ] ; relative risk 0.51 [ 95 % CI 0.32-0 .84 ] ) .
RESULTS	The number needed to treat was 4.5 ( 95 % CI 2.6-15 .6 ) .
CONCLUSIONS	Lactobacillus GG was effective in prevention of early atopic disease in children at high risk .
CONCLUSIONS	Thus , gut microflora might be a hitherto unexplored source of natural immunomodulators and probiotics , for prevention of atopic disease .

###15870666
OBJECTIVE	To investigate the effect of hydrocortisone treatment on survival without bronchopulmonary dysplasia ( BPD ) and to study whether serum cortisol concentrations predict the response .
METHODS	We performed a randomized , placebo-controlled trial on infants with gestation < or = 30 weeks , body weight of 501 to 1250 g , and respiratory failure .
METHODS	Hydrocortisone was started before 36 hours of age and given for 10 days at doses from 2.0 to 0.75 mg/kg per day .
METHODS	Shortly before hydrocortisone treatment , basal and stimulated ( ACTH , 0.1 microg/kg ) serum cortisols were measured .
RESULTS	The study was discontinued early , because of gastrointestinal perforations in the hydrocortisone group ( 4/25 vs 0/26 , P = .05 ) ; 3 of the 4 had received indomethacin/ibuprofen .
RESULTS	The incidence of BPD ( 28 % vs placebo 42 % , P = 0.28 ) tended to be lower , and patent ductus arteriosus ( 36 % vs 73 % , P = .01 ) was lower in the hydrocortisone group .
RESULTS	The hydrocortisone-treated infants with serum cortisol concentrations above the median had a high risk of gastrointestinal perforation .
RESULTS	In infants with cortisol values below the median , hydrocortisone treatment increased survival without BPD .
CONCLUSIONS	Serum cortisol concentrations measured shortly after birth may identify those very high-risk infants who may benefit from hydrocortisone supplementation .

###19709893
BACKGROUND	Thoracotomy is a surgical procedure associated with severe pain .
BACKGROUND	Operative morbidity rates reduce by effective postoperative pain control .
BACKGROUND	The aim of this study is to compare the effectiveness of the thoracic epidural blockade ( TEB ) and the paravertebral blockade ( PVB ) methods in relieving the pain caused by a thoracotomy incision .
METHODS	We studied 44 consecutive patients who underwent elective posterolateral thoracotomy .
METHODS	The patients were classed into two groups : TEB ( n = 19 ) and PVB ( n = 25 ) .
METHODS	Patients in both the groups could self-control the infusion of bupivacaine infusion and diclofenac sodium .
METHODS	The groups were compared according to the parameters such as analgesic efficacy ( VAS ) , respiratory function tests ( forced expiratory volume in 1s ( FEV ( 1 ) ) , peak expiratory flow rate ( PEFR ) and arterial blood gases ) , stress response ( serum cortisol and glucose levels ) , adverse effects , necessity for additional analgesia , duration of catheter application procedure , mean hospital stay and postoperative follow-up .
METHODS	Results are analysed statistically by Mann-Whitney U , Wilcoxon , chi-square and Fisher 's exact tests , and a p-value of < 0.05 was accepted to be statistically significant .
RESULTS	There was no significant difference between the two groups with regard to age , gender , VAS , FEV ( 1 ) , PEFR , serum cortisol and glucose levels , necessity for additional analgesia and hospital staying days .
RESULTS	In contrast , adverse effects and duration of catheterisation were statistically significantly lower in group PVB ( p = 0.001 and p < 0.001 , respectively ) .
CONCLUSIONS	PVB catheterisation can be easily performed and placed in a short span perioperatively .
CONCLUSIONS	Therefore , it might be the preferred method over TEB which has a high incidence of adverse effects and complication rates .

###12794815
OBJECTIVE	To observe the long-term safety and efficacy of combination therapy with etanercept and methotrexate in patients with rheumatoid arthritis ( RA ) , and to determine whether the addition of etanercept allowed reductions in methotrexate or corticosteroid dosages while maintaining a clinical response .
METHODS	Patients with RA who received methotrexate plus etanercept in a previous randomized , placebo-controlled trial were offered the opportunity to enroll in an open-label extension study for further evaluation of treatment with etanercept and methotrexate .
RESULTS	Seventy-nine of the 89 patients in the original blinded study enrolled in the extension study , and 65 of these patients continue in the study .
RESULTS	Patients have received etanercept therapy for up to 47 months ( median 44 months ) .
RESULTS	The types and rate of adverse events noted during the extension trial were similar to those observed in the controlled trial .
RESULTS	At the 3-year assessment , 77 % of the 57 patients available for evaluation met American College of Rheumatology 20 % ( ACR20 ) criteria for improvement in RA , 47 % met the ACR50 criteria , and 23 % met the ACR70 criteria .
RESULTS	Of the 36 patients assessed at 3 years in the extension study , 30 ( 83 % ) were able to decrease their dosages of corticosteroids , and 20 ( 56 % ) were able to discontinue corticosteroid therapy .
RESULTS	At 3 years , the dosage of methotrexate was decreased in 41 of 66 patients ( 62 % ) , and methotrexate therapy was discontinued in 19 patients ( 29 % ) .
CONCLUSIONS	In this observational continuation study , the addition of etanercept to background methotrexate provided sustained clinical benefit over a median period of 44 months .
CONCLUSIONS	With etanercept therapy , there were trends toward dosage reduction or discontinuation of methotrexate and corticosteroids , without apparent worsening of ACR response rates .
CONCLUSIONS	Compared with the controlled trial , no increases in the rate of adverse events were observed .

###9431897
OBJECTIVE	Contradictory reports have been published on gastric emptying in patients with liver cirrhosis .
OBJECTIVE	The differences have been attributed to differences in the innervation of the stomach or in the behaviour of the gastric wall .
OBJECTIVE	The type of test meal used may , however , have its importance .
OBJECTIVE	We looked for the role of the test meal in the assessment of gastric emptying in cirrhosis .
METHODS	In a prospective study , we included 15 patients with liver cirrhosis who had no symptoms of autonomic neuropathy , portal hypertensive gastropathy or antral vascular ectasia and 15 controls .
METHODS	In these subjects we estimated the gastric emptying and varied the type of test meals .
METHODS	An ultrasonographic method was used for the estimation of gastric emptying .
METHODS	Antral area was monitored in the aorto-mesenteric plane in the fasting condition and at 0 , 15 , 30 , 45 , 60 min after a test meal .
METHODS	Each patient was tested twice on 2 consecutive days in randomized order with a liquid meal ( 220 kJ ) and a semisolid meal ( 1472 kJ ) .
RESULTS	Fasting antral areas ( mean + / - SD ) had similar size in both groups with both meals .
RESULTS	Gastric emptying ( expressed by the area under the curve and half-time ( T1/2 ) ) of the semisolid meal was not different in cirrhosis ( 2347 + / - 1648 ) compared to controls ( 2840 + / - 1983 ) .
RESULTS	Postprandial antral distension was also similar in both groups ( 312.2 + / - 133.6 % in cirrhosis vs. 397.9 + / - 155.6 % in controls ) .
RESULTS	But emptying of the liquid meal was accelerated in the cirrhotic patients with respect to the area under the curve ( AUC : 882 + / - 548 ) and half-time ( 12 + / - 2 min ) vs. controls ( AUC : 1863 + / - 1088 , P < 0.01 ; T1/2 : 18 + / - 7 min , P < 0.05 ) .
RESULTS	Postprandial antral distension with the liquid meal was decreased ( 299.4 + / - 76.5 % vs. 431.5 + / -154.0 % , P < 0.01 , in controls ) .
CONCLUSIONS	These data suggest that in patients with liver cirrhosis free of autonomic neuropathy and without portal hypertensive gastropathy or vascular antral ectasia , gastric emptying of liquid low calorie meals is accelerated .
CONCLUSIONS	The gastric emptying of a semisolid meal richer in calories is normal .
CONCLUSIONS	Thus , the physical and chemical properties of a meal are major determinants of gastric emptying and may account for the large divergence of results hitherto published on this topic .

###9875081
OBJECTIVE	To study the effects of oestrogen replacement treatment on fibrinolytic potential in postmenopausal women .
METHODS	Randomised , double blind , placebo controlled trial of oral 17 beta-oestradiol .
METHODS	Subjects were evaluated in the outpatient setting .
METHODS	Nineteen postmenopausal women with mild dyslipidaemia , aged 44 to 69 years ( mean ( SD ) 55.7 ( 6.7 ) ) .
METHODS	Fibrinolytic activity ( fibrin plate assay ) and tissue plasminogen activator ( t-PA ) antigen were measured at baseline and after three , six , and nine weeks of each treatment .
RESULTS	After nine weeks of 2 mg oestradiol treatment , there was a significant increase in fibrinolytic potential compared with placebo , as indicated by an increase in fibrinolytic activity ( mean ( SEM ) , 80 ( 9 ) v 54 ( 5 ) mm2 of lysis in the fibrin plate , 2 mg v placebo , p = 0.002 ) and a decrease in t-PA antigen ( 5.8 ( 0.9 ) v 8.4 ( 1.2 ) ng/ml , 2 mg v placebo , p < 0.001 ) .
RESULTS	There was a similar trend with the 1 mg dose but the changes were less noticeable .
CONCLUSIONS	Hormone replacement treatment with 17 beta-oestradiol for nine weeks significantly increased fibrinolytic potential in postmenopausal women with mild dyslipidaemia .
CONCLUSIONS	This suggests that the cardioprotective effect of oestrogen may be mediated , in part , by an increase in fibrinolytic potential .

###16447051
OBJECTIVE	Pioglitazone , a thiazolidinedione antidiabetic , inhibits cytochrome P450 ( CYP ) 2C8 and CYP3A4 enzymes in vitro .
OBJECTIVE	Repaglinide , a meglitinide analogue antidiabetic , is metabolised by CYP2C8 and CYP3A4 .
OBJECTIVE	In patients with type 2 diabetes , the pioglitazone-repaglinide combination has acted synergistically on glycaemic parameters .
OBJECTIVE	Our aim was to determine whether pioglitazone increases the plasma concentrations of repaglinide .
METHODS	In a randomized , 2-phase cross-over study , 12 healthy volunteers received 30 mg pioglitazone or placebo once daily for 5 days .
METHODS	On day 5 , they ingested a single 0.25 mg dose of repaglinide 1 h after the last pretreatment dose .
METHODS	Plasma repaglinide and pioglitazone , and blood glucose concentrations were measured for 12 h.
RESULTS	During the pioglitazone phase , the mean peak plasma repaglinide concentration ( C ( max ) ) and the total area under the concentration-time curve [ AUC ( 0-infinity ) ] of repaglinide were 100 % ( range 53-157 % , P = 0.99 ) and 90 % ( range 63-120 % , P = 0.22 ) , respectively , of those during the placebo phase .
RESULTS	Also the half-life of repaglinide was unaffected , but the median peak time of repaglinide was shortened from 40 min to 20 min by pioglitazone ( P = 0.014 ) .
RESULTS	The short-term pioglitazone administration did not modify the blood glucose-lowering effect of a single dose of repaglinide .
CONCLUSIONS	Pioglitazone does not increase the plasma concentrations of repaglinide , indicating that the inhibitory effect of pioglitazone on CYP2C8 and CYP3A4 is very weak in vivo , probably due to its extensive plasma protein binding .
CONCLUSIONS	The synergistic effect of repaglinide and pioglitazone on the glycaemic parameters , seen in patients with type 2 diabetes during their long-term use , is unlikely to be caused by inhibition of repaglinide metabolism by pioglitazone .

###15162970
OBJECTIVE	Male caregivers are growing in number , as the frequency of spouse caregiving rapidly increases .
OBJECTIVE	This study aimed to examine gender differences in family caregivers with reference to the mode of caregiving and caregiver distress in Japan .
OBJECTIVE	It was designed to clarify the characteristics of both female and male caregivers .
METHODS	The subjects were 2,020 users of public Long-term Care Insurance , randomly stratified and sampled in Higashi-osaka city , Osaka prefecture .
METHODS	Data were collected through mailed , anonymous self-report questionnaires .
METHODS	1,287 ( 63.7 % ) surveys were collected and data from 868 caregivers and care recipients were analyzed , after excluding incomplete cases from 947 participants who were family caregivers .
METHODS	We compared males and females for the level of nursing needs , cognitive disorders of their care recipients , the types and amounts of care provided , the levels of their burdens and the depression associated with providing care , the availability of informal support , the frequency of usage of Long-term care insurance services , and the types of stress coping strategies .
RESULTS	Of the total , 27.1 % of the caregivers were male .
RESULTS	Their age was higher than that of females , but the age of care recipients of female caregivers was significantly higher than that of care recipients of males .
RESULTS	There were no significant gender differences in the level of nursing needs of recipients .
RESULTS	However , cognitive disorders of care recipients of female caregivers were more severe .
RESULTS	Female caregivers spent more time providing care , and performed a greater number of care activities .
RESULTS	In particular , female caregivers assisted their care recipients in taking medications , dressing , bathing , eating , meal preparation , shopping , laundry , and money management more often to a significant degree .
RESULTS	Furthermore , the average scores for burden and depression were higher in female than in male caregivers .
RESULTS	Concerning the usage of Long-term care insurance services , males used a Home-helper service more often .
RESULTS	Female caregivers used types of Informal support seeking and Positive acceptance of caregiving role as coping strategies more often than the men .
RESULTS	Multiple logistic regression analysis indicated that caregiver 's subjective burden and types of informal support seeking , as well as acceptance of the caregiving role were significantly higher in female caregivers .
CONCLUSIONS	These results suggest that there are significant gender differences regarding the mode of caregiving and experience of caregiver distress in Japan .
CONCLUSIONS	It is important that future research be focused on supplying appropriate social support for family caregivers , taking gender differences into account .

###21651736
BACKGROUND	Evidence is needed on the effectiveness of non-pharmaceutical interventions ( NPIs ) to reduce influenza transmission .
METHODS	We studied NPIs in households with a febrile , influenza-positive child .
METHODS	Households were randomized to control , hand washing ( HW ) , or hand washing plus paper surgical face masks ( HW + FM ) arms .
METHODS	Study nurses conducted home visits within 24 hours of enrollment and on days 3 , 7 , and 21 .
METHODS	Respiratory swabs and serum were collected from all household members and tested for influenza by RT-PCR or serology .
RESULTS	Between April 2008 and August 2009 , 991 ( 165 % ) of 5995 pediatric influenza-like illness patients tested influenza positive .
RESULTS	Four hundred and forty-two index children with 1147 household members were enrolled , and 221 ( 500 % ) were aged < 6 years .
RESULTS	Three hundred and ninety-seven ( 898 % ) households reported that the index patient slept in the parents ' bedroom .
RESULTS	The secondary attack rate was 215 % , and 56/345 ( 163 % ; 95 % CI 124-202 % ) secondary cases were asymptomatic .
RESULTS	Hand-washing subjects reported 47 washing episodes/day , compared to 49 times/day in the HW + FM arm and 39 times/day in controls ( P = 0001 ) .
RESULTS	The odds ratios ( ORs ) for secondary influenza infection were not significantly different in the HW arm ( OR = 120 ; 95 % CI 076-188 ; P-0 .442 ) , or the HW + FM arm ( OR = 116 ; 95 % CI .074 -182 ; P = 0.525 ) .
CONCLUSIONS	Influenza transmission was not reduced by interventions to promote hand washing and face mask use .
CONCLUSIONS	This may be attributable to transmission that occurred before the intervention , poor facemask compliance , little difference in hand-washing frequency between study groups , and shared sleeping arrangements .
CONCLUSIONS	A prospective study design and a careful analysis of sociocultural factors could improve future NPI studies .

###16752617
OBJECTIVE	To investigate the optimization of multidisciplinary and interdisciplinary oral health care through the introduction of pathways .
METHODS	A prospective randomized clinical trial was carried out in a tertiary referral academic institution .
METHODS	Ninety-one patients admitted for multidisciplinary oral health care from January 1 , 2001 , to March 31 , 2003 , were randomized to the test group ( n = 50 ) or to the control group ( n = 41 ) .
METHODS	Pathways were implemented by means of the Medical Patient Management program , a computerized planning and coordination system specifically developed for a population with multidisciplinary oral rehabilitation needs .
METHODS	The efficiency of pathways in interdisciplinary oral health care was assessed .
RESULTS	Statistically significant differences between test and control groups were found for variables regarding the process of care , such as `` number of planned versus actual disciplines , '' `` length of planned versus actual treatment , '' and `` average length of a treatment session . ''
RESULTS	For variables regarding patient satisfaction , significant differences between test and control groups were found for questions regarding patient involvement with the treatment and patient satisfaction with the outcome of multidisciplinary treatment .
RESULTS	Regarding practitioner satisfaction , the results of the questionnaire indicate that implementation of pathways into everyday clinical practice is desired but remains difficult .
CONCLUSIONS	The findings of this study show that the implementation of pathways in multidisciplinary oral health care improved some aspects of the process of care and increased patient satisfaction .
CONCLUSIONS	The predictive capability of the Medical Patient Management program in managing oral health care has been demonstrated .

###19371492
OBJECTIVE	The aim of this research was to study marijuana use , associated risks , and response to brief motivational intervention among young adult drinkers treated in an emergency department .
METHODS	Study participants ( N = 215 ; ages 18-24 ) were in a randomized controlled trial for alcohol use that compared motivational interviewing with personalized feedback ( MI ) with personalized feedback only .
METHODS	Past-month marijuana users were compared with nonusers on demographics , readiness , self-efficacy , and behavioral risk variables .
METHODS	Marijuana use was examined as a potential moderator of alcohol outcomes .
METHODS	Whether marijuana use alone or combined marijuana and alcohol use would be reduced as a result of brief intervention for alcohol was examined at 6 and 12 months .
RESULTS	Current marijuana users were younger , were more likely to be white , and reported more alcohol use , other illicit drug use , and more alcohol-related consequences than nonmarijuana users .
RESULTS	Marijuana use at baseline did not moderate response to brief alcohol treatment .
RESULTS	Marijuana use declined from baseline to 6 months for both treatment groups , but only MI participants continued to reduce their use of marijuana from 6 - to 12-month follow-up .
RESULTS	Reductions in number of days of use of marijuana with alcohol appeared to be primarily a function of decreased alcohol use .
CONCLUSIONS	Young adult drinkers reporting current marijuana use are at generally higher risk but responded to brief alcohol treatment by reducing alcohol and marijuana use .

###10084524
OBJECTIVE	In Lithuania , there is little awareness of the notion that chronic symptoms may result from rear end collisions via the so-called whiplash injury .
OBJECTIVE	After most such collisions no contact with the health service is established .
OBJECTIVE	An opportunity therefore exists to study post-traumatic pain without the confounding factors present in western societies .
METHODS	In a prospective , controlled inception cohort study , 210 victims of a rear end collision were consecutively identified from the daily records of the Kaunas traffic police .
METHODS	Neck pain and headache were evaluated by mailed questionnaires shortly after the accident , after 2 months , and after 1 year .
METHODS	As controls , 210 sex and age matched subjects were randomly taken from the population register of the same geographical area and evaluated for the same symptoms immediately after their identification and after 1 year .
RESULTS	Initial pain was reported by 47 % of accident victims ; 10 % had neck pain alone , 18 % had neck pain together with headache , and 19 % had headache alone .
RESULTS	The median duration of the initial neck pain was 3 days and maximal duration 17 days .
RESULTS	The median duration of headache was 4.5 hours and the maximum duration was 20 days .
RESULTS	After 1 year , there were no significant differences between the accident victims and the control group concerning frequency and intensity of these symptoms .
CONCLUSIONS	In a country were there is no preconceived notion of chronic pain arising from rear end collisions , and thus no fear of long term disability , and usually no involvement of the therapeutic community , insurance companies , or litigation , symptoms after an acute whiplash injury are self limiting , brief , and do not seem to evolve to the so-called late whiplash syndrome .

###25194621
OBJECTIVE	Muscle atrophy and weakness impair activity of daily living ( ADL ) .
OBJECTIVE	We examined whether chair stand exercise can improve ADL of hemodialysis patients .
METHODS	A randomized controlled trial .
METHODS	A single center study .
METHODS	Outpatients on hemodialysis older than 60 years ( 61-79years ) .
METHODS	Twelve weeks of intervention with chair stand exercise , 3 sessions/week versus the control exercise ( stretch , 1 session/week ) .
METHODS	The primary outcome was the change in functional independence measure ( FIM ) score from baseline .
METHODS	The secondary outcomes were changes in thigh circumference , muscle strength of quadriceps , 6-minute walking distance , maximum duration of chair stand exercise , health-related quality of life , cognitive function serum albumin , and hemoglobin .
RESULTS	Among the 27 patients who were randomized , 17 completed the study .
RESULTS	The change in FIM from baseline was greater in the intervention group ( 1 [ 1-3 ] vs. 0 [ 0-0 ] , median ( minimum to maximum ) , P < .001 ) due to the significant improvement in the FIM subscales related to mobility ( bed/chair/wheel chair ) and locomotion ( stair ) .
RESULTS	Among the secondary outcomes , significant difference was noticed in the changes in thigh circumference and the physical component summary score of health-related quality of life by Medical Outcome Study 36-Item Short-Form Health Survey ( SF-36v2 ) .
CONCLUSIONS	Chair stand exercise improved ADL in the hemodialysis patients aged older than 60years .

###12504399
BACKGROUND	New antimalarial treatments are urgently needed in sub-Saharan Africa .
BACKGROUND	Improved therapies should decrease failure rates in the short term , but their effect on incidence of subsequent episodes of malaria is little studied .
BACKGROUND	We aimed to compare the short-term and long-term effectiveness of three antimalarial regimens in children from Kampala , Uganda .
METHODS	We randomly allocated healthy children aged 6 months to 5 years to receive 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine plus either placebo , 25 mg/kg amodiaquine , or 12 mg/kg artesunate .
METHODS	Participants were followed up for 1 year and received the same preassigned treatment for every new episode of uncomplicated malaria diagnosed during follow-up .
METHODS	Recrudescent and new infections were distinguished by comparison of polymorphisms in merozoite surface protein 2 ( MSP2 ) .
METHODS	Our primary endpoint was the total number of treatments for malaria per time at risk .
METHODS	Analyses were done per protocol .
RESULTS	183 ( 61 % ) of 316 participants were diagnosed with at least one episode of uncomplicated malaria .
RESULTS	A total of 577 episodes of uncomplicated Plasmodium falciparum malaria were treated with study drugs ; all regimens were safe and well tolerated .
RESULTS	Clinical treatment failure after 14 days was significantly more frequent in the sulfadoxine/pyrimethamine group ( 38 of 215 , 18 % ) compared with either the sulfadoxine/pyrimethamine plus amodiaquine group ( two of 164 , 1 % ; p < 0.0001 ) or sulfadoxine/pyrimethamine plus artesunate group ( one of 198 , 1 % ; p < 0.0001 ) .
RESULTS	After 28 and 42 days , patients in the sulfadoxine/pyrimethamine plus amodiaquine group were significantly less likely to develop malaria than were those in the other groups .
RESULTS	Overall , sulfadoxine/pyrimethamine plus amodiaquine reduced the rate of subsequent treatments for malaria by 54 % ( 95 % CI 36-66 , p < 0.0001 ) compared with sulfadoxine / pyrimethamine alone and by 37 % ( 12-54 , p = 0.007 ) compared with sulfadoxine/pyrimethamine plus artesunate .
CONCLUSIONS	Sulfadoxine/pyrimethamine plus amodiaquine could be used as an inexpensive regimen to decrease the rate of subsequent episodes of malaria .

###24387642
BACKGROUND	Interface choice is crucial for non-invasive ventilation ( NIV ) success .
BACKGROUND	We compared a new interface , the helmet next ( HN ) , with the facial mask ( FM ) and the standard helmet ( HS ) in twelve healthy volunteers .
METHODS	In this study , five NIV trials were randomly applied , preceded and followed by a trial of unassisted spontaneous breathing ( SB ) .
METHODS	Baseline settings , for example , 5 cmH2O of both inspiratory pressure support ( PS ) and positive end-expiratory pressure ( PEEP ) , were applied through FM , HS and HN , while increased settings ( PS and PEEP of 8 cmH2O ) were only applied through HS and HN .
METHODS	We measured flow , airway , esophageal and gastric pressures , and calculated inspiratory effort indexes and trigger delays .
METHODS	Comfort was assessed with a visual-analog-scale .
RESULTS	We found that FM , HS and HN at baseline settings were not significantly different with respect to inspiratory effort indexes and comfort .
RESULTS	Inspiratory trigger delay and time of synchrony ( TI , synchrony ) were significantly improved by FM compared to both helmets , whereas expiratory trigger delay was shorter with FM , as opposed to HS only .
RESULTS	HN at increased settings performed better than FM in decreasing inspiratory effort measured by pressure-time product of transdiaphragmatic pressure ( PTPdi ) / breath ( 10.79.9 versus 17.011.0 cmH2Os ) , and PTPdi/min ( 12896 versus 20481 cmH2Os/min ) , and PTPdi/L ( 12.69.9 versus 30.216.8 cmH2Os/L ) .
RESULTS	TI , synchrony was inferior between HN and HS at increased settings and FM .
CONCLUSIONS	HN might hold some advantages with respect to interaction and synchrony between subject and ventilator , but studies on patients are needed to confirm these findings .
BACKGROUND	ClinicalTrials.gov NCT01610960 .

###9187187
OBJECTIVE	To compare the effects of noninvasive assist-control ventilation ( ACV ) and pressure support ventilation ( PSV ) by nasal mask on respiratory physiologic parameters and comfort in acute hypercapnic respiratory failure ( AHRF ) .
METHODS	A prospective randomized study .
METHODS	A medical ICU .
METHODS	Fifteen patients with COPD and AHRF were consecutively and randomly assigned to two noninvasive ventilation ( NIV ) sequences with ACV and PSV mode , spontaneous breathing ( SB ) via nasal mask being used as control .
METHODS	ACV and PSV settings were always subsequently adjusted according to patient 's tolerance and air leaks .
METHODS	Fraction of inspired oxygen did not change between the sequences .
RESULTS	ACV and PSV mode strongly decreased the inspiratory effort in comparison with SB .
RESULTS	The total inspiratory work of breathing ( WOBinsp ) expressed as WOBinsp/tidal volume ( VT ) and WOBinsp/respiratory rate ( RR ) , the pressure time product ( PTP ) , and esophageal pressure variations ( deltaPes ) were the most discriminant parameters ( p < 0.001 ) .
RESULTS	ACV most reduced WOBinsp/VT ( p < 0.05 ) , deltaPes ( p < 0.05 ) , and PTP ( 0.01 ) compared with PSV mode .
RESULTS	The surface diaphragmatic electromyogram activity was also decreased > 32 % as compared with control values ( p < 0.01 ) , with no difference between the two modes .
RESULTS	Simultaneously , NIV significantly improved breathing pattern ( p < 0.01 ) with no difference between ACV and PSV for VT , RR , minute ventilation , and total cycle duration .
RESULTS	As compared to SB , respiratory acidosis was similarly improved by both modes .
RESULTS	The respiratory comfort assessed by visual analog scale was less with ACV ( 57.23 + / -30.12 mm ) than with SB ( 75.15 + / -18.25 mm ) ( p < 0.05 ) and PSV mode ( 81.62 + / -25.2 mm ) ( p < 0.01 ) in our patients .
CONCLUSIONS	During NIV for AHRF using settings adapted to patient 's clinical tolerance and mask air leaks , both ACV and PSV mode provide respiratory muscle rest and similarly improve breathing pattern and gas exchange .
CONCLUSIONS	However , these physiologic effects are achieved with a lower inspiratory workload but at the expense of a higher respiratory discomfort with ACV than with PSV mode .

###15371787
OBJECTIVE	We report a prospective randomized controlled study to evaluate the possible benefits of sacral neuromodulation ( SNM ) for the management of neurogenic bladder dysfunction in children .
METHODS	We included in the study subjects between the ages of 5 and 21 years presenting with urinary incontinence due to neurogenic bladder .
METHODS	Before study inclusion all previous treatment was discontinued .
METHODS	Patients were randomly divided into the control group treated conventionally and the implant group treated with SNM .
METHODS	Treatment outcome was compared every 3 months for a minimum of 12 months based on clinical examination , voiding diary and urodynamic evaluation .
RESULTS	A total of 26 boys and 16 girls with a mean age of 11.9 years were enrolled in this study .
RESULTS	There were 21 patients in each group .
RESULTS	The main underlying etiology was spina bifida .
RESULTS	The 2 groups were comparable with regard to sex , age and urodynamic variables .
RESULTS	Total disappearance of urinary leakage was observed in 1 patient who underwent implantation but he still required intermittent catheterization .
RESULTS	Comparison of urodynamic variables disclosed no significant statistical difference except with regard to functional bladder capacity which was better in the control group and the leak point pressure which was better in the implant group ( p < 0.05 ) .
RESULTS	Evaluation of interindividual variations in the implant group revealed significant improvement in compliance and functional bladder capacity at 6 and 9 months but not at 12 months .
RESULTS	Nine patients in the implant group reported improvement in intestinal transit , 5 total disappearance of urinary infection and 6 persistent sensation of a full bladder .
RESULTS	No patient in the control group reported any improvement .
RESULTS	Revision surgery was required in 3 cases due to lead migration , faulty connection and wound infection .
CONCLUSIONS	SNM is a promising new therapeutic modality .
CONCLUSIONS	Implant placement is minimally invasive , nondestructive and reversible .
CONCLUSIONS	Use in children with neurogenic bladder has not been previously reported .
CONCLUSIONS	Although some improvement was noted in patients treated with SNM , the difference with the control group was not significant .
CONCLUSIONS	A larger multicenter study is warranted to evaluate SNM .

###14616414
OBJECTIVE	Voriconazole , a new triazole antifungal agent , is metabolized mainly by cytochrome P450s CYP2C19 and CYP2C9 , and also by CYP3A4 .
OBJECTIVE	The aim of this open-label , placebo-controlled , randomized , three-way crossover study was to determine the effects of cimetidine and ranitidine on the steady-state pharmacokinetics of voriconazole .
METHODS	Twelve healthy male subjects received oral voriconazole 200 mg twice daily plus cimetidine 400 mg twice daily , voriconazole 200 mg twice daily plus ranitidine 150 mg twice daily , and voriconazole 200 mg twice daily plus placebo twice daily .
METHODS	Treatment periods were separated by at least 7 days .
RESULTS	When cimetidine was administered with voriconazole , the maximum plasma voriconazole concentration ( Cmax ) and the area under the plasma concentration-time curve of voriconazole ( AUCtau ) was increased by 18.3 % [ 90 % confidence interval ( CI ) 6.0 , 32.0 ] and 22.5 % ( 90 % CI 13.3 , 32.5 ) , respectively .
RESULTS	Concomitant ranitidine had no significant effect on voriconazole Cmax or AUCtau .
RESULTS	Time of Cmax ( tmax ) elimination half-life ( t 1/2 ) or terminal phase rate constant ( kel ) for voriconazole were similar in all three treatment groups .
RESULTS	Most adverse events were mild and transitory ; two subjects were withdrawn due to adverse events .
CONCLUSIONS	Coadministration of the histamine H2-receptor antagonists cimetidine or ranitidine does not affect the steady-state pharmacokinetics of voriconazole in a clinically relevant manner .

###23428340
OBJECTIVE	To evaluate the image quality of contrast-enhanced chest computed tomography ( CT ) with low tube voltage settings using an iterative reconstruction algorithm ( iDose4 ) and standard dose filtered back projection ( FBP ) CT in patients with normal body mass index ( BMI ) .
METHODS	Eighty patients with normal BMI were referred for a contrast-enhanced chest CT. .
METHODS	Patients were randomly assigned into two groups : 120kVp and 80kVp .
METHODS	Standard convolution FBP was used to reconstruct the 120kVp group ( A ) and 80kVp group ( C ) image sets and iterative reconstruction ( iDose4 ) was used to reconstruct the 80kVp group ( B ) image sets .
METHODS	The mean image noise , signal-to-noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) , and effective dose ( ED ) were calculated for each protocol .
METHODS	Image quality was graded ( scale : 1-3 ) and compared among the three groups .
RESULTS	The radiation dose was 71.35 % less for the low-voltage protocol .
RESULTS	Noise was significantly lower in the low-voltage images reconstructed with iDose4 ( group B ) compared with images reconstructed with FBP ( group C ) .
RESULTS	Group B had the highest SNR and CNR .
RESULTS	There was no difference in subjective image quality scores between groups B and A ( p > 0.05 ) .
CONCLUSIONS	Compared with standard FBP reconstruction , the iDose4 iterative reconstruction yields higher SNR , CNR , and better image quality in contrast-enhanced chest CT with low tube voltage settings .

###17986903
OBJECTIVE	Studies attributing gains in strength and lean body mass ( LBM ) to creatine monohydrate ( CrM ) during resistance exercise ( RE ) training have not assessed these changes alongside cellular and subcellular adaptations .
OBJECTIVE	Additionally , CrM-treated groups have seldom been compared with a group receiving a placebo similar in nitrogen and energy .
OBJECTIVE	The purpose of this study was to examine the effects of a CrM-containing protein-carbohydrate ( PRO-CHO ) supplement in comparison with a supplement containing a similar amount of nitrogen and energy on body composition , muscle strength , fiber-specific hypertrophy , and contractile protein accrual during RE training .
METHODS	In a double-blind , randomized protocol , resistance-trained males were matched for strength and placed into one of three groups : protein ( PRO ) , PRO-CHO , or the same PRO-CHO supplement ( 1.5 g x kg ( -1 ) body weight x d ( -1 ) ) containing CrM ( Cr-PRO-CHO ) ( 0.1 g x kg ( -1 ) body weight x d ( -1 ) ) .
METHODS	Assessments were completed the week before and after a 10-wk structured , supervised RE program : strength ( 1RM , three exercises ) , body composition ( DEXA ) , and vastus lateralis muscle biopsies for determination of muscle fiber type ( I , IIa , IIx ) , cross-sectional area ( CSA ) , contractile protein , and creatine content .
RESULTS	Cr-PRO-CHO provided greater improvements in 1RM strength .
RESULTS	At least 40 % of the strength improvements could be attributed to hypertrophy of muscle involved in this exercise .
RESULTS	Cr-PRO-CHO also resulted in greater increases in LBM , fiber CSA , and contractile protein compared with PRO and PRO-CHO .
CONCLUSIONS	In RE-trained participants , supplementation with Cr-PRO-CHO provided greater muscle hypertrophy than an equivalent dose of PRO-CHO , and this response was apparent at three levels of physiology ( LBM , fiber CSA , and contractile protein content ) .

###16208081
OBJECTIVE	This study was done to determine the effects of walking exercise training ( WET ) on metabolic syndrome risk factors and body composition in obese middle school girls .
METHODS	A non-equivalent pretest-posttest experimental design was used .
METHODS	Twenty seven subjects participated in this study from one women 's middle school in Busan .
METHODS	The participants were purposely allocated to an experimental group ( n = 14 ) and a control group ( n = 13 ) .
METHODS	The experimental group participated in 30-60 minutes of WET with 55 to 75 % of a maximal heart rate six days a week for 12 weeks .
RESULTS	The prevalence of individual risk factors on metabolic syndrome were improved in the experimental group after the intervention .
RESULTS	The high waist circumference ( WC ) , high triglyceride ( TG ) , low high density lipoprotein cholesterol ( HDL-C ) , high blood pressure ( BP ) and high fasting glucose ( FG ) were 21.4 , 21.4 , 14.3 , 28.6 and 7.2 % , respectively .
RESULTS	There were significant differences in WC ( F = 22.24 , p < .001 ) , TG ( F = 5.34 , p = 0.30 ) , body weight ( F = 21.99 , p < .001 ) , fat mass ( F = 19.17 , p < .001 ) , and % body fat ( F = 17.93 , p < .001 ) between the experimental and control group after the intervention .
RESULTS	However , there were no significant differences in HDL-C , FG and BP between the experimental and control group after the intervention .
CONCLUSIONS	These results indicate that WET is effective in decreasing risk factors of the metabolic syndrome and body composition components in obese middle school girls .
CONCLUSIONS	These findings suggest that WET can be useful as a nursing intervention in the prevention of obesity-related disorders in obese adolescents .

###11097131
BACKGROUND	Apart from their vasodilatatory properties , nitrates have been shown to inhibit platelet aggregation .
BACKGROUND	The effects of nitrates on platelet adhesion have not been studied .
BACKGROUND	Nonselected patients with acute myocardial infarction ( AMI ) have been suggested to gain no benefit from administration of nitrates .
BACKGROUND	However , the importance of nitrates may be greater in a subgroup of nonthrombolyzed patients with AMI .
OBJECTIVE	Isosorbide dinitrate ( ISDN ) decreases platelet adhesion and aggregation in nonthrombolyzed patients with AMI .
METHODS	Consecutive 48 men with AMI , not eligible for thrombolytic therapy because of late presentation ( > 12 h ) , were prospectively randomized 2:1 to double-blind ISDN ( mean dose 2.4 + / - 0.9 mg/h ) ( n = 33 ) or placebo ( 0.9 % sodium chloride ) ( n = 15 ) infusion .
METHODS	All patients received aspirin .
METHODS	Blood samples were taken at baseline ( no study medication ) and 3 h into ISDN or placebo infusion .
METHODS	Platelet adhesion to collagen was measured in the ethylene diamine tetraacetic acid ( EDTA ) - platelet rich plasma by recording changes in light transmission with an optical aggregometer .
METHODS	Platelet aggregation was measured using the Born 's method .
RESULTS	Isosorbide dinitrate significantly decreased both platelet adhesion and aggregation .
RESULTS	No effect was seen in the placebo group .
CONCLUSIONS	In patients with AMI who do not receive thrombolytic therapy , ISDN effectively inhibits platelet adhesion and aggregation .
CONCLUSIONS	These effects of nitrates may be of therapeutic and prognostic significance in this group of patients .

###9865617
BACKGROUND	The carbonic anhydrase inhibitor acetazolamide ( AZM ) reduces macular oedema in some patients with retinitis pigmentosa .
BACKGROUND	To better understand the oedema-reducing effect of AZM , the effect of AZM on passive permeability and active transport of fluorescein across the blood-retina barrier was studied in patients with retinitis pigmentosa and varying degrees of macular oedema .
METHODS	The selection of patients was based on an introductory examination including vitreous fluorometry for qualitative assessment of the vitreous .
METHODS	Macular oedema was graded by fluorescein angiographic leakage .
METHODS	The effect of AZM on the transport properties of the blood-retina barrier was determined by differential spectrofluorometry , in a randomised , double-masked , cross-over study , comprising 2 weeks ' treatment with AZM ( 500 mg/day ) and 2 weeks ' treatment with placebo .
METHODS	The penetration ratio , defined as the ratio between vitreous concentration 3 mm in front of the retina and the plasma integral , was determined for fluorescein and its metabolite fluorescein glucuronide at 30-60 min and at 120 min after fluorescein injection .
METHODS	Passive permeability and unidirectional permeability in the direction vitreous to blood , due to outward active transport of fluorescein , were determined in those cases where the curves for vitreous concentration of fluorescein could be fitted to a mathematical model .
METHODS	Visual acuity was tested by use of ETDRS standard logarithmic charts .
RESULTS	Twenty-two patients volunteered to participate in the study .
RESULTS	Signs of significant vitreous detachment/liquefaction caused the exclusion of ten patients after the introductory examination .
RESULTS	Nine patients with approximately intact vitreous and varying degrees of oedema completed the cross-over study .
RESULTS	AZM treatment was related to a decrease in the penetration ratio of 21 % for fluorescein ( P = 0.01 ) and of 22 % for fluorescein glucuronide ( P = 0.004 ) .
RESULTS	Passive permeability and unidirectional permeability were determined in seven patients .
RESULTS	AZM caused a decrease of 27 % in the passive permeability of fluorescein ( from 1.1 x 10 ( 1 ) nm/s , P = 0.031 ) , and a 95 % increase in unidirectional permeability of fluorescein ( from 1.2 x 10 ( 2 ) nm/s , P = 0.047 ) .
RESULTS	AZM led to a reduction in the grade of macular oedema as determined by fluorescein angiography in three out of seven patients .
RESULTS	Only small improvements ( < or = 5 letters ) in visual acuity were noted .
CONCLUSIONS	The present study indicates that the oedema-reducing effect of AZM is due to decreased leakage and stimulated active transport across the blood-retina barrier .

###10088569
BACKGROUND	Recombinant human growth hormone ( rhGH ) has been shown to favorably modulate the acute-phase response and may improve the clinical outcome .
OBJECTIVE	To examine whether rhGH attenuates the elevated tumor necrosis factor alpha ( TNF-alpha ) levels that correlate with increased multiorgan failure and mortality in burned adults and children .
METHODS	Twenty children with burns of greater than 40 % of the total body surface area were randomly divided into 2 groups to receive placebo ( n = 10 ) or rhGH , 0.2 mg/kg per day intramuscularly ( n = 10 ) .
METHODS	Pediatric burn hospital .
METHODS	Serum TNF-alpha levels by enzyme-linked immunoassay at baseline ( day 0 ) and at 21 and 42 days after injury .
METHODS	For statistical analysis , we used the Kruskal-Wallis and Friedman tests .
RESULTS	No significant differences in age ( mean + / - SD , 6.2 + / -1.6 vs 5.0 + / -1.2 years ) or percentage of total body surface area burn ( mean + / - SD , 65.1 % + / -8.2 % vs 57.1 % + / -5.2 % ) could be shown between the groups given rhGH and placebo .
RESULTS	Baseline TNF-alpha levels were elevated from reference values in both groups .
RESULTS	Twenty-one and 42 days after rhGH administration , serum TNF-alpha levels were significantly decreased from those at baseline ( P < .05 ) .
RESULTS	No significant decrease in TNF-alpha levels was observed in the placebo group ( P = .5 ) .
CONCLUSIONS	Recombinant human growth hormone significantly lowers serum TNF-alpha levels after burn injury .
CONCLUSIONS	This is consistent with the beneficial effect that rhGH has on the acute-phase response .

###23170990
OBJECTIVE	This study was designed to assess the efficacy and safety of the dipeptidyl peptidase IV inhibitor gemigliptin ( LC15-0444 ) 50 mg versus placebo in patients with type 2 diabetes .
METHODS	We conducted a 24-week , randomized , double-blind , placebo-controlled phase III trial in 182 patients ( 74 from Korea and 108 from India ) with type 2 diabetes .
METHODS	After an initial 2 weeks of a diet and exercise programme followed by 2 weeks of a single-blind placebo run-in period , eligible patients were randomized to gemigliptin 50 mg or placebo , receiving the assigned treatment for 24 weeks .
METHODS	HbA1c and fasting plasma glucose ( FPG ) were measured periodically , and oral glucose tolerance test was performed at baseline and weeks 12 and 24 .
RESULTS	At week 24 , gemigliptin treatment led to significant reductions in HbA1c measurements compared to placebo ( adjust mean after subtracting the placebo effect size : -0.71 % , 95 % confidence interval : -1.04 to -0.37 % ) .
RESULTS	A significantly greater proportion of patients achieved an HbA1c < 7 % with gemigliptin than with placebo .
RESULTS	The placebo-subtracted FPG change from baseline at week 24 was -19.80 mg/dl .
RESULTS	The overall incidence rates for adverse events were similar in the gemigliptin and placebo groups .
CONCLUSIONS	This study showed the efficacy and safety of gemigliptin 50 mg administered once daily as a monotherapy for type 2 diabetes patients .

###25201533
OBJECTIVE	To evaluate the efficacy of a large capsulorhexis and intraocular lens ( IOL ) in obtaining a larger anterior capsule opening after cataract surgery in patients with diabetes mellitus ( DM ) .
METHODS	Department of Ophthalmology , University of Fukui , Fukui , Japan .
METHODS	Prospective clinical trial .
METHODS	Patients with DM had bilateral cataract surgery with a 2.8 or 3.0 mm scleral incision , a capsulorhexis with a diameter of approximately 5.0 or 6.0 mm , and implantation of a 6.0 mm optic ( Eternity X-60 ) or 7.0 mm optic ( Eternity X-70 ) IOL .
METHODS	The anterior capsule opening area , aqueous flare intensity , surgically induced astigmatism ( SIA ) , corneal endothelial cell density ( ECD ) , and central corneal thickness ( CCT ) were measured 1 day , 1 week , and 1 , 3 , and 6 months after surgery .
RESULTS	Thirty-one patients ( 62 eyes ) with DM were enrolled .
RESULTS	At all postoperative timepoints , the anterior capsule opening was significantly larger in eyes with the 7.0 mm optic IOL than in eyes with the 6.0 mm optic IOL ( P < .05 , Mann-Whitney U test ) .
RESULTS	There were no significant differences in postoperative aqueous flare intensity , SIA , ECD , or CCT based on the size of the capsulorhexis and IOL .
CONCLUSIONS	A larger capsulorhexis and implantation of a 7.0 mm IOL resulted in a larger anterior capsule opening after cataract surgery in patients with DM .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###8688387
OBJECTIVE	To assess the effect of low dose aspirin on severe pre-eclampsia when given to women identified as high risk by abnormal uterine artery Doppler ultrasound .
METHODS	Women with abnormal uterine artery flow velocity waveforms were recruited to the CLASP trial at 24 weeks .
METHODS	Abnormal uterine artery waveforms , with a high resistance index or an early diastolic notch , were identified at the 18-22 week anomaly scan and confirmed at 24 weeks .
METHODS	Of those women with persistently abnormal waveforms , 63 agreed to enter the CLASP trial .
METHODS	Three women were lost to follow up and five did not comply .
METHODS	Thus , 60 were randomised : 29 to placebo and 31 to low dose aspirin ( 60 mg daily ) and analysis by intention to treat is reported .
RESULTS	There were nine cases ( 29 % ) of pre-eclampsia in the aspirin group and twelve ( 41 % ) in the placebo group ( odds ratio ( OR ) 0-58 , confidence interval ( CI ) 0.2-1 .69 , P = 0.32 ) .
RESULTS	Severe pre-eclampsia developed in four women in the aspirin group and eleven women in the placebo group ( OR 0.24 , CI 0.07-0 .88 , P = 0.03 ) and intrauterine growth retardation occurred in eight cases in the aspirin group and twelve in the placebo group ( OR 0.49 , CI 0.17-1 .47 ) .
RESULTS	The mean birthweight and gestation at delivery were 2.69 kg and 38.5 weeks in the aspirin group and 2.38 kg and 37.4 weeks in the placebo group , neither of which were statistically significant using the unpaired t test ; P = 0.09 and P = 0.23 , respectively .
CONCLUSIONS	In high risk pregnancy low dose aspirin commenced at 24 weeks may reduce the incidence of severe pre-eclampsia .

###19183462
BACKGROUND	The diabetes of many patients is managed in general practice ; healthcare providers aim to promote healthful behaviors , such as healthful diet , adequate physical activity , and smoking cessation .
BACKGROUND	These measures may decrease insulin resistance , improve glycemic control , lipid abnormalities , and hypertension .
BACKGROUND	They may also prevent cardiovascular disease and complications of diabetes .
BACKGROUND	However , professionals do not adhere optimally to guidelines for lifestyle counseling .
BACKGROUND	Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling .
BACKGROUND	Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice .
BACKGROUND	The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses ' training on patient outcomes .
METHODS	A cluster , randomized , controlled trial involving 70 general practices ( 35 practices in the intervention arm and 35 in the control arm ) starting in March 2007 .
METHODS	A total of 700 patients with type 2 diabetes will be recruited .
METHODS	The patients in the intervention arm will receive care from the primary care nurse , who will receive training in an implementation strategy with motivational interviewing as the core component .
METHODS	Other components of this strategy will be adaptation of the diabetes protocol to local circumstances , introduction of a social map for lifestyle support , and educational and supportive tools for sustaining motivational interviewing .
METHODS	The control arm will be encouraged to maintain usual care .
METHODS	The effect measures will be the care process , metabolic parameters ( glycosylated hemoglobin , blood pressure and lipids ) , lifestyle ( diet , physical activity , smoking , and alcohol ) , health-related quality of life , and patients ' willingness to change behaviors .
METHODS	The measurements will take place at baseline and after 14 months .
CONCLUSIONS	Applying motivational interviewing for patients with diabetes in primary care has been studied , but to our knowledge , no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice .
CONCLUSIONS	If this intervention proves to be effective and cost-effective , large-scale implementation of this nurse-oriented intervention will be considered and anticipated .
BACKGROUND	Current Controlled Trials ISRCTN68707773 .

###15914575
OBJECTIVE	Melatonin , a sleep promoting agent , is involved in the regulation of gastrointestinal motility and sensation .
OBJECTIVE	We aimed to determine if melatonin was effective in improving bowel symptoms and sleep disturbances in irritable bowel syndrome ( IBS ) patients with sleep disturbance .
METHODS	Forty IBS patients ( aged 20-64 years ; 24 female ) with sleep disturbances were randomly assigned to receive either melatonin 3 mg ( n = 20 ) or matching placebo ( n = 20 ) at bedtime for two weeks .
METHODS	Immediately before and after the treatment , subjects completed bowel , sleep , and psychological questionnaires , and underwent rectal manometry and overnight polysomnography .
RESULTS	Compared with placebo , melatonin taken for two weeks significantly decreased mean abdominal pain score ( 2.35 v 0.70 ; p < 0.001 ) and increased mean rectal pain threshold ( 8.9 v -1.2 mm Hg ; p < 0.01 ) .
RESULTS	Bloating , stool type , stool frequency , and anxiety and depression scores did not significantly differ after treatment in both groups .
RESULTS	Data from sleep questionnaires and polysomnography showed that the two week course of melatonin did not influence sleep parameters , including total sleep time , sleep latency , sleep efficiency , sleep onset latency , arousals , duration of stages 1-4 , rapid eye movement ( REM ) sleep , and REM onset latency .
CONCLUSIONS	Administration of melatonin 3 mg at bedtime for two weeks significantly attenuated abdominal pain and reduced rectal pain sensitivity without improvements in sleep disturbance or psychological distress .
CONCLUSIONS	The findings suggest that the beneficial effects of melatonin on abdominal pain in IBS patients with sleep disturbances are independent of its action on sleep disturbances or psychological profiles .

###21081251
OBJECTIVE	The aim of the present study was to evaluate the safety , tolerability , clinical and haemodynamic impact of add-on sildenafil in patients with congenital heart disease ( CHD ) - related pulmonary arterial hypertension ( PAH ) and Eisenmenger physiology after failure of oral bosentan therapy .
METHODS	Thirty-two patients with CHD-related PAH ( 14 male , mean age 37.1 13.7 years ) treated with oral bosentan underwent right heart catheterization ( RHC ) for clinical worsening .
METHODS	After RHC , all patients received oral sildenafil 20mg thrice daily in addition to bosentan .
METHODS	Clinical status , resting transcutaneous oxygen saturation ( SpO ( 2 ) ) , 6-minute walk test ( 6MWT ) , serology and RHC were assessed at baseline ( before add-on sildenafil ) and after 6 months of combination therapy .
RESULTS	Twelve patients had ventricular septal defect , 8 atrio-ventricular canal , 6 single ventricle , and 6 atrial septal defect .
RESULTS	Twenty-eight/32 had Eisenmenger physiology and 4 ( all with atrial septal defect ) did not .
RESULTS	All patients well tolerated combination therapy .
RESULTS	After 6 months of therapy , an improvement in clinical status ( WHO functional class 2.1 0.4 vs 2.9 0.3 ; P = 0.042 ) , 6-minute walk distance ( 360 51 vs 293 68 m ; P = 0.005 ) , SpO ( 2 ) at the end of the 6MWT ( 72 10 vs 63 15 % ; P = 0.047 ) , Borg score ( 2.9 1.5 vs 4.4 2.3 ; P = 0.036 ) , serology ( pro-brain natriuretic peptide 303 366 vs 760 943 pg/ml ; P = 0.008 ) and haemodynamics ( pulmonary blood flow 3.4 1.0 vs 3.1 1.2 l/min/m ( 2 ) , P = 0.002 ; pulmonary vascular resistances index 19 9 vs 24 16 WU/m ( 2 ) , P = 0.003 ) was observed .
CONCLUSIONS	Addition of sildenafil in adult patients with CHD-related PAH and Eisenmenger syndrome after oral bosentan therapy failure is safe and well tolerated at 6-month follow-up , resulting in a significant improvement in clinical status , effort SpO ( 2 ) , exercise tolerance and haemodynamics .

###21849078
BACKGROUND	Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers .
BACKGROUND	Care as usual primarily consists of pharmacotherapy and supportive treatment .
BACKGROUND	However , a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes , persistent interepisodic symptoms and poor social functioning .
BACKGROUND	Both psychiatric and somatic comorbid disorders are frequent , especially personality disorders , substance abuse , cardiovascular diseases and diabetes .
BACKGROUND	Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment .
BACKGROUND	` Collaborative Care ' is a treatment method that could meet these needs .
BACKGROUND	Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder .
BACKGROUND	In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands .
METHODS	The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care ( CC ) in comparison with Care as usual ( CAU ) in outpatient clinics for bipolar disorder or mood disorders in general .
METHODS	Collaborative Care includes individually tailored interventions , aimed at personal goals set by the patient .
METHODS	The patient , his caregiver , the nurse and the psychiatrist all are part of the Collaborative Care team .
METHODS	Elements of the program are : contracting and shared decision making ; psycho education ; problem solving treatment ; systematic relapse prevention ; monitoring of outcomes and pharmacotherapy .
METHODS	Nurses coordinate the program .
METHODS	Nurses and psychiatrists in the intervention group will be trained in the intervention .
METHODS	The effects will be measured at baseline , 6 months and 12 months .
METHODS	Primary outcomes are psychosocial functioning , psychiatric symptoms , and quality of life .
METHODS	Caregiver outcomes are burden and satisfaction with care .
CONCLUSIONS	Several ways to enhance the quality of this study are described , as well as some limitations caused by the complexities of naturalistic treatment settings where not all influencing factors on an intervention and the outcomes can be controlled .
BACKGROUND	The Netherlands Trial Registry , NTR2600 .

###19034343
OBJECTIVE	To assess the value of external shielding of the testis during pelvic radiotherapy .
METHODS	Nineteen patients , receiving radiotherapy to the pelvis with the lower border of the field at the obturator foramen , were randomly selected .
METHODS	A 5 half value layer cerrobent shield was positioned at the inferior border of the field .
METHODS	The dose to the testis was measured with and without the shield .
METHODS	Observations were made regarding the reflex cremaster contraction and phantom measurements were done at different distances from the perineum .
RESULTS	The mean radiation dose to the testis for patients receiving treatment with no shield was 7.4 cGy ( 1.3 ) and it was 5.7 cGy ( - / +2.5 ) for patients with external shield , this difference was statistically significant by the paired t test p < 0.0001 .
RESULTS	This accounted for a 22 % decrease in the dose received by the testis .
RESULTS	The position of the testis with the contraction of the cremaster muscle and the dartos fascia after manipulation of the testis during diodes placement changed up to 3.5 cm ( mean 1.5 ) .
RESULTS	Phantom measurements showed 37 % increase in the dose with 2cm change in the position of the testis to the pelvic direction .
CONCLUSIONS	External shield at the inferior border of the pelvic field is a simple , easy reproducible , convenient shielding method .
CONCLUSIONS	Clam-shell scrotal shield is not free of drawbacks , but still its benefits overweigh its harms and should be used with caution .

###18763689
OBJECTIVE	This study was designed to determine the effects of twice daily tooth brushing with the Sonicare Elite ( Elite ) and the Oral-B P40 manual toothbrush ( MTB ) on plaque accumulation and plaque-induced gingival inflammation .
METHODS	One-hundred and eighty ( 180 ) subjects , with moderate gingival inflammation and a Silness and Le Plaque Index ( PI ) of > or = 0.8 after refraining from oral hygiene for three to six hours , were randomly assigned to receive the Elite or MTB in this single-blinded , controlled clinical trial .
METHODS	At baseline and after two and four weeks of using the product at home twice daily for two minutes , efficacy was assessed with the PI and the Le and Silness Gingival Index ( GI ) after brushing three to six hours prior to assessment The primary efficacy variable was reduction of baseline plaque scores over the four weeks for Elite compared to MTB .
METHODS	Secondary outcomes included a change in GI and number of bleeding sites .
METHODS	Safety was appraised using adverse event reports and soft tissue examinations .
RESULTS	One-hundred and sixty-eight subjects ( 81 Elite , 87 MTB ) completed the study .
RESULTS	The four-week study period resulted in significant reductions of PI and GI from baseline at weeks two and four for both brushes .
RESULTS	Reduction in mean PI from baseline to week four for Elite was 0.84 ( 95 % CI : 0.80 , 0.88 ) , and 0.72 ( 0.68 , 0.76 ) for MTB , p < 0.0001 .
RESULTS	Reduction in mean GI from baseline to four weeks for Elite was 0.56 ( 0.53 , 0.59 ) , and 0.47 ( 0.45 , 0.50 ) for MTB , p = 0.0001 .
RESULTS	Both treatment groups demonstrated a significant reduction in number of bleeding sites relative to baseline ( p < 0.0001 ) ; however , a significant difference in percent reduction in favor of Elite relative to MTB was found at week four : 82.5 % vs. 75.8 % ( p = 0.026 ) .
RESULTS	Both toothbrushes were safe on oral tissues .
CONCLUSIONS	Elite was significantly more effective than MTB in the reduction of plaque after two and four weeks of product use , and significantly more effective in the reduction of gingivitis and bleeding sites than MTB after four weeks .

###10989241
OBJECTIVE	To assess the effects of bilateral oophorectomy on the resting ECG and whether they regress with estrogen replacement therapy .
METHODS	Twenty-six premenopausal and 15 postmenopausal women were enrolled in the present study .
METHODS	All women had undergone hysterectomy and bilateral ovariectomy .
METHODS	All women underwent 12-lead ECG on admission to hospital .
METHODS	A second ECG was recorded 20-25 days after surgery .
METHODS	After this second ECG , premenopausal women were randomly divided into two groups .
METHODS	The women of Group A ( n = 14 ) received transdermal ethinyl estradiol ( EE ) .
METHODS	The women of Group B ( n = 12 ) did not receive any therapy .
METHODS	A third ECG was performed in both groups 30-35 days after randomization .
RESULTS	Bilateral oophorectomy did not induce any significant modifications in the ECG parameters of the postmenopausal women whereas in the premenopausal women , we observed a significant increment in mean duration of the T wave , a significant decrease in its amplitude and significant reduction in ST depression in V2 , V3 , V4 and V5 .
RESULTS	The third ECG showed regression of the ECG modifications in Group A.
RESULTS	In the women of Group B , the second and third ECGs were not substantially different , but there were statistically significant differences between the first and third ECGs .
CONCLUSIONS	The results of the present study show that ovariectomy induces significant though not clinically evident modifications in resting ECG .
CONCLUSIONS	These ECG changes are probably due to the sudden reduction in sex hormone plasma levels after ovariectomy .
CONCLUSIONS	Administration of estradiol induced regression of the ECG modifications .

###9462573
OBJECTIVE	The Veterans Affairs Non-Q-Wave Infarction Strategies In-Hospital ( VANQWISH ) trial was designed to compare outcomes of patients with a non-Q wave myocardial infarction ( NQMI ) who were randomized prospectively to an early `` invasive '' strategy versus an early `` conservative '' strategy .
OBJECTIVE	The primary objective was to compare early and late outcomes between the two strategies using a combined trial end point ( all-cause mortality or nonfatal infarction ) during at least 1 year of follow-up .
BACKGROUND	Because of the widely held view that survivors of NQMI are at high risk for subsequent cardiac events , management of these patients has become more aggressive during the last decade .
BACKGROUND	There is a paucity of data from controlled trials to support such an approach , however .
METHODS	Appropriate patients with a new NQMI were randomized to an early `` invasive '' strategy ( routine coronary angiography followed by myocardial revascularization , if feasible ) versus an early `` conservative '' strategy ( noninvasive , predischarge stress testing with planar thallium scintigraphy and radionuclide ventriculography ) , where the use of coronary angiography and myocardial revascularization was guided by the development of ischemia ( clinical course or results of noninvasive tests , or both ) .
RESULTS	A total of 920 patients were randomized ( mean follow-up 23 months , range 12 to 44 ) .
RESULTS	The mean patient age was 61 + / - 10 years ; 97 % were male ; 38 % had ST segment depression at study entry ; 30 % had an anterior NQMI ; 54 % were hypertensive ; 26 % had diabetes requiring insulin ; 43 % were current smokers ; 43 % had a previous acute myocardial infarction ; and 45 % had antecedent angina within 3 weeks of the index NQMI .
CONCLUSIONS	Baseline characteristics were compatible with a moderate to high risk group of patients with an NQMI .

###19667999
OBJECTIVE	To investigate the efficacy of insulin-sensitizing agents in nonalcoholic fatty liver disease ( NAFLD ) patients .
METHODS	This is an open-label , randomized , a single-center study .
METHODS	Sixty-four patients , with impaired glucose metabolism and elevated alanine aminotransferase for at least 6 months before enrollment and NAFLD activity score at least 5 in liver biopsy , were randomized as group 1 and received metformin 1700 mg/day , group 2 received rosiglitazone 4 mg/day , and group 3 received a combination of metformin 1700 mg/day and rosiglitazone 4 mg/day for 12 months .
RESULTS	Baseline demographic and laboratory findings were similar in all the three groups , except baseline insulin level that was significantly higher in group 1 and group 3 versus group 2 ( P < 0.05 ) .
RESULTS	Serum transaminase levels showed a significant decrease after treatment in both group 2 and group 3 .
RESULTS	Serum gamma-glutamyl transpeptidase levels decreased significantly only in the group 3 .
RESULTS	However , there was no significant change in liver tests of group 1 .
RESULTS	Postprandial glucose levels showed significant decrease in all of the three groups .
RESULTS	Homeostasis model assessment-insulin resistance was reduced significantly in only group 2 .
RESULTS	NAFLD score was significantly decreased on follow-up biopsy of the patients in group 2 and group 3 .
RESULTS	Fibrosis did not change significantly after the treatment .
CONCLUSIONS	Rosiglitazone therapy seems to be more effective in metabolic control and histological improvement in NAFLD patients with impaired glucose metabolism .

###17395870
OBJECTIVE	Because the long-term security of endovascular treatments remains uncertain , a follow-up study of the patients treated in the International Subarachnoid Aneurysm Trial was performed to compare the frequency , timing , and consequences of aneurysm recurrence .
METHODS	Patient data were reclassified by actual treatment performed .
METHODS	Aneurysm and patient characteristics , including occlusion grades , time and type of retreatment , and clinical outcomes , were compared .
METHODS	The relationship between these variables and late retreatment as a surrogate for recurrence was analyzed by means of the Cox proportional hazards model .
RESULTS	Retreatment was performed in 191 of 1096 ( 17.4 % ) patients after primary endovascular coiling ( EVT ) and in 39 of 1012 patients ( 3.8 % ) after neurosurgical clipping .
RESULTS	After EVT , 97 ( 8.8 % ) patients were retreated early and 94 ( 9.0 % ) late , 7 ( 0.6 % ) after rebleeding and 87 ( 8.3 % ) without .
RESULTS	The mean time to late retreatment was 20.7 months .
RESULTS	After neurosurgical clipping , 30 ( 2.9 % ) patients were retreated early and 9 ( 0.85 % ) late , 3 ( 0.3 % ) after rebleeding and 6 ( 0.6 % ) without .
RESULTS	The mean time to late retreatment was 5.7 months .
RESULTS	The hazard ratio ( HR ) for retreatment after EVT was 6.9 ( 95 % CI = 3.4 to 14.1 ) after adjustment for age ( P = 0.001 , HR = 0.97 , 95 % CI = 0.95 to 0.98 ) , lumen size ( P = 0.006 , HR = 1.1 , 95 % CI = 1.03 to 1.18 ) , and incomplete occlusion ( P < 0.001 , HR = 7.6 , 95 % CI = 3.3 to 17.5 ) .
CONCLUSIONS	Late retreatment was 6.9 times more likely after EVT .
CONCLUSIONS	Younger age , larger lumen size , and incomplete occlusion were risk factors for late retreatment after EVT .
CONCLUSIONS	After neurosurgical clipping , retreatments were earlier ; whereas EVT retreatments continued to be performed throughout the follow-up period .
CONCLUSIONS	Short-term follow-up imaging is therefore insufficient to detect recurrences after EVT .

###12548303
OBJECTIVE	It is known that the immune system is frequently affected in patients with head and neck cancer .
OBJECTIVE	Although immune dysfunction could be multifactorial , this immune system may be modulated by specific nutritional substrates , such as arginine .
OBJECTIVE	The aim of our study was to evaluate the effect of enteral nutrition supplemented with arginine on c-reactive protein ( CRP ) , interleukin 6 ( IL-6 ) and tumour necrosis factor ( TNFalpha ) in surgical head and neck cancer patients .
METHODS	Randomized trial .
METHODS	Tertiary care .
METHODS	A population of 36 patients with oral and laryngeal cancer were enrolled .
METHODS	At surgery patients were randomly allocated to two groups : ( a ) patients receiving an enteral diet supplements with arginine and dietary fibre ( group I , n = 18 ) ; ( b ) patients receiving an isocaloric , isonitrogenous enteral formula ( group II , n = 18 ) .
METHODS	Perioperatively and on postoperative day 5 the following parameters were evaluated : serum values of prealbumin , transferrin , albumin , total number of lymphocytes , interleukin 6 , tumour necrosis factor alpha and c-reactive protein .
RESULTS	The mean age was 59.6 + / -10.9 y ( two females/34 males ) .
RESULTS	No significant intergroup differences in the trend of the three plasma proteins and weight were detected .
RESULTS	CRP decreased in both groups ( group I : 152.9 + / -76.9 vs 68.9 + / -82.5 mg/dl ; P < 0.05 ; and group II : 105.9 + / -92 vs 43.6 + / -59.1 mg/dl ; P < 0.05 ) .
RESULTS	Interleukin 6 did not change ( group I : 16.3 + / -12.3 vs 35.6 + / -83.4 pg/ml ; NS ; and group II : 22.8 + / -40 vs 9.9 + / -17.7 pg/ml ; NS ) .
RESULTS	TNFalpha did not show any differences ( group I : 4.6 + / -1.6 vs 5.1 + / -1.5 pg/ml ; NS ; and group II : 8.8 + / -6.1 vs 5.8 + / -1.7 pg/ml ; NS ) .
RESULTS	Lymphocytes increased in both groups ( group I : 1405.6 + / -517 vs 1634 + / -529 x 10 ( 6 ) / ml ; P < 0.05 ; and group II : 1355 + / -696 vs 1561 + / -541 x 10 ( 6 ) / ml ; P < 0.05 ) .
CONCLUSIONS	Enhanced formula did not change IL6 and TNFalpha levels .
CONCLUSIONS	Further studies are needed to determine whether route of nutrition or type of formula is the key in these patients .

###15564275
OBJECTIVE	To assess the effectiveness of a primary care referral scheme on increasing physical activity at 1 year from referral .
OBJECTIVE	Design Two-group randomized controlled trial recruiting primary care referrals to a borough-based exercise scheme .
OBJECTIVE	Setting A local authority borough in the north-west of England .
OBJECTIVE	Participants 545 patients defined as sedentary by a primary care practitioner .
OBJECTIVE	Intervention Referral to a local-authority exercise referral scheme and written information compared with written information only .
OBJECTIVE	Main outcome measures Meeting physical activity target at 12 months following referral , with a secondary outcome measured at 6 months from referral .
RESULTS	At 12 months , a non-significant increase of 5 per cent was observed in the intervention compared with control group , for participation in at least 90 minutes of moderate/vigorous activity per week ( 25.8 versus 20.4 per cent , OR 1.45 , 0.84 to 2.50 , p = 0.18 ) .
RESULTS	At 6 months , a 10 per cent treatment effect was observed which was significant ( 22.6 versus 13.6 per cent , OR 1.67 , 1.08 to 2.60 , p = 0.05 ) .
RESULTS	The intervention increased satisfaction with information but this did not influence adherence with physical activity .
CONCLUSIONS	Community-based physical activity referral schemes have some impact on reducing sedentary behaviour in the short-term , but which is unlikely to be sustained and lead to benefits in terms of health .

###17043957
OBJECTIVE	To evaluate the safety and efficacy of compression anastomosis clip ( CAC ) for small bowel anastomosis .
METHODS	Forty gastric cancer patients undergoing total gastrectomy were randomly divided into two groups and received side-to-side Roux-en-Y small bowel anastomosis with CAC or stapler .
METHODS	The following parameters were recorded : small bowel anastomotic complication , first post-operation flatus and bowel movement , extrusion of clip device .
RESULTS	Neither group had small bowel anastomotic complications such as leakage or obstruction .
RESULTS	The clip was expelled with stool within 9-16 days .
RESULTS	Two groups had the similar results in recovery of bowel function .
CONCLUSIONS	CAC is safe and simple for small bowel anastomosis .

###14557150
OBJECTIVE	To examine the contributions of community reinforcement therapy to outcome in the community reinforcement approach ( CRA ) + vouchers outpatient treatment for cocaine dependence .
METHODS	One hundred cocaine-dependent outpatients were randomly assigned to one of 2 treatment conditions : CRA + vouchers or vouchers only .
METHODS	All patients earned incentives in the form of vouchers exchangeable for retail items contingent on cocaine-free urinalysis results during treatment weeks 1 to 12 .
METHODS	Incentives were combined with a 24-week course of CRA therapy designed to promote healthy lifestyle changes in the CRA + vouchers condition , while incentives represented the primary treatment in the vouchers-only condition .
METHODS	Patient drug use and psychosocial functioning were assessed at intake and at least every 3 months for 2 years after treatment entry .
RESULTS	Patients treated with CRA + vouchers were retained better in treatment , used cocaine at a lower frequency during treatment but not follow-up , and reported a lower frequency of drinking to intoxication during treatment and follow-up compared with patients treated with vouchers only .
RESULTS	Patients treated with CRA + vouchers also reported a higher frequency of days of paid employment during treatment and the initial 6 months of follow-up , decreased depressive symptoms during treatment only , and fewer hospitalizations and legal problems during follow-up .
CONCLUSIONS	Combining CRA with vouchers had therapeutic effects on substance abuse and psychosocial functioning during treatment and posttreatment follow-up in cocaine-dependent outpatients , although effects on cocaine use appear to be limited to the treatment period .

###9389815
OBJECTIVE	To investigate whether establishment and maintenance of chronic opioid blockade throughout the follicular phase of the menstrual cycle influences midcycle and luteal phase prolactin levels .
METHODS	Randomized , double-blind , crossover study .
METHODS	Academic research environment .
METHODS	Volunteers , aged 21-35 years , with regular menstrual cycles .
METHODS	Naltrexone ( 50 mg ) or placebo were administered on cycle days 2-14 .
METHODS	Blood samples were obtained in the early follicular phase and in the periovulatory and midluteal phases of the menstrual cycle .
METHODS	Serum prolactin levels .
RESULTS	In the early follicular phase , serum prolactin levels were equivalent in naltrexone ( 12.0 + / - 2.7 microgram/L ; mean + / - SE ) and placebo ( 12.1 + / - 2.9 micrograms/L ) cycles .
RESULTS	A statistically significant increase in serum prolactin was observed on the day of the LH surge ( naltrexone : 22.6 + / - 3.7 micrograms/L ; placebo : 21.7 + / - 2.7 micrograms/L ; P < 0.05 versus early follicular phase ) , but no difference between treatments was observed .
RESULTS	However , midluteal prolactin levels were statistically significantly lower in naltrexone cycles compared with placebo cycles ( 12.6 + / - 3.3 versus 15.4 + / - 3.0 micrograms/L ; P < 0.05 ) .
CONCLUSIONS	Chronic blockade of opioid activities during the follicular phase does not affect midcycle prolactin increments , but withdrawal of opioid blockade may enhance opioid effects on prolactin levels in the luteal phase .

###21873668
OBJECTIVE	There is evidence from several large-scale clinical trials that reduced intake of lutein , a major component of the macular pigment , is a risk factor for the development of AMD .
OBJECTIVE	In the present study ( LISA ; Lutein Intervention Study Austria ) it was hypothesized that lutein supplementation increases macular pigment optical density ( MPOD ) .
OBJECTIVE	In addition , an investigation was conducted into whether lutein supplementation improves visual acuity ( VA ) and macular function ( mean differential light threshold ; MDLT ) , as assessed with microperimetry .
METHODS	One hundred twenty-six patients with AMD ( AREDS [ Age-related Eye Disease Study ] stages 2 , 3 , and 4 ) were included in this randomized ( 2:1 ) , placebo-controlled , double-masked parallel group study .
METHODS	Lutein or placebo was administered for 6 months .
METHODS	MPOD was measured with a custom-built reflectometer .
METHODS	VA was assessed with ETDRS ( Early Treatment Diabetic Retinopathy Study ) charts , and MDLT was assessed with a microperimeter .
RESULTS	Lutein significantly increased MPOD by 27.9 % 2.9 % ( P < 0.001 versus placebo ) .
RESULTS	No significant effect of lutein supplementation on MDLT or VA was seen , although a tendency toward an increase was seen for both parameters ( MDLT , P = 0.096 versus placebo ; VA , P = 0.070 versus placebo ) .
RESULTS	A significant correlation was found , however , between the increase in MPOD after 6 months and the increase in MDLT after 6 months ( r = 0.25 , P = 0.027 ) , as well as between the increase in MPOD after 6 months and the increase in VA after 6 months ( r = 0.27 , P = 0.013 ) .
CONCLUSIONS	The present study demonstrates that lutein supplementation increases MPOD , as assessed with an objective
METHODS	The correlation between the change in MPOD and the change in VA and MDLT indicates that patients who show a pronounced increase in MPOD also benefit in terms of visual function .
METHODS	( ClinicalTrials.gov number , NCT00879671 . )

###12133743
BACKGROUND	Through a re-analysis of a Tai Chi intervention data set , the study objective was to determine which , if any , subgroups of the study sample evidenced differential benefits from the intervention .
METHODS	Re-analysis of a Tai Chi intervention study , a randomized controlled trial in Eugene and Springfield , Oregon .
METHODS	Physically inactive participants aged > or = 65 years were randomly assigned to one of two groups : Tai Chi ( n = 49 ) and a wait-list control ( n = 45 ) .
METHODS	The main outcome measure was self-reported physical function .
RESULTS	Initial latent curve analyses indicated significant Tai Chi training effects : Participants in the Tai Chi group reported significant improvements in perceived physical function compared to those in the control group .
RESULTS	However , there was significant interindividual variability in response to Tai Chi .
RESULTS	The overall intervention effect was further delineated by identifying two subgroups .
RESULTS	This delineation showed that Tai Chi participants with lower levels of physical function at baseline benefited more from the Tai Chi training program than those with higher physical function scores .
RESULTS	Inclusion of additional measures of individual characteristics at baseline , change in movement confidence , and class attendance further explained differences in treatment responses .
CONCLUSIONS	Findings from this study suggest that although an intervention may show an overall effect ( or no overall effect ) , it may be differentially effective for subgroups of participants that differ in their pre-intervention characteristics .
CONCLUSIONS	Examination of variability in outcome measures can provide important information for refining and tailoring appropriate interventions targeted to specific subgroups .

###15049961
OBJECTIVE	In women , GH secretion is strongly influenced by oestrogen status , whereas the role of androgens is unclear .
OBJECTIVE	We , therefore , examined GH secretory dynamics during low vs. normalized androgen levels in women with adrenal failure .
METHODS	Ten females with adrenal failure ( AF ) , mean age of 42 years ( range 22-54 years ) .
METHODS	The effects of 8 days of oral dehydroepiandrosterone ( DHEA ; 50 mg/day ) were studied in a double-blind placebo-controlled , cross-over design .
METHODS	A control group of healthy women was studied once without any treatment .
METHODS	Before and after each treatment period , blood was sampled for measurement of androgens , IGF-I , IGFBP-3 and GHBP .
METHODS	A 24-h GH profile with measurements every 20 min was performed at the end of each period .
RESULTS	DHEA supplementation normalized the mean circulating levels of testosterone and androgen precursors .
RESULTS	The secretory pattern of GH was unaltered during DHEA [ placebo vs. DHEA ; half-life 22.83 + / - 1.24 vs. 21.45 + / - 1.19 ( min ) , P = 0.429 ; pulse frequency 9.9 + / - 0.7 vs. 10.5 + / - 0.5 ( / 24 h ) , P = 0.502 ; total production rate 62.27 + / - 13.44 vs. 52.61 + / - 7.06 ( microg/l/day ) , P = 0.317 ] .
RESULTS	Subgroup analysis , however , indicated that DHEA treatment increased GH secretion in patients not receiving oestrogen ( n = 5 ) , whereas the opposite was observed among patients receiving exogenous oestrogen derivatives ( n = 5 ) .
RESULTS	Compared to the control group ( CON ) , GH half-life was longer in AF ( half-life CON : 16.48 + / - 0.91 , P = 0.001 ) .
RESULTS	The additional features of GH secretion were similar .
RESULTS	Unexpectedly , the levels of IGF-I , IGFBP-3 and GHBP were elevated in the patients as compared to controls , without significant effects of DHEA [ AF vs. CON .
RESULTS	IGF-I : 186 + / - 20 vs. 144 + / - 7 ( microg/l ) , P = 0.04 ; IGFBP-3 : 5196 + / - 224 vs. 3687 + / - 212 ( microg/l ) , P = 0.001 ; GHBP : 2.27 + / - 0.25 vs. 1.41 + / - 0.13 ( nmol/l ) , P = 0.002 ] .
CONCLUSIONS	( 1 ) Short-term DHEA administration in women with adrenal failure normalizes the circulating levels of androgens without uniformly affecting the GH-IGF axis ; ( 2 ) The observation that exogenous oestradiol may mask a stimulatory effect of DHEA on GH secretion merits future investigation .

###21447515
BACKGROUND	In the context of a multisite HIV prevention trial in Southern African women , we examined the effectiveness of the Ortho All-Flex Diaphragm , lubricant gel ( Replens ) and condoms compared to condoms alone on the incidence of herpes simplex virus type 2 ( HSV-2 ) infections .
METHODS	We analysed data from 2016 sexually active women in Zimbabwe and South Africa .
METHODS	Women were followed quarterly , and specimens obtained at the closing visit from previously HSV-2 seronegative women were retested for HSV-2 antibodies using Focus HerpeSelect Elisa .
METHODS	The first visit at which the participant tested positive for HSV-2 was defined by back-testing .
METHODS	We compared the incidence of HSV-2 after randomisation between study arms in both intent-to-treat ( ITT ) and per-protocol populations .
RESULTS	210 women acquired HSV-2 during study participation ( HSV incidence : 6.8 cases/100 women years ) .
RESULTS	Allocation to the intervention arm was found to offer no benefit in reduction of HSV-2 by modified ITT ( HR 1.03 , 95 % CI 0.78 to 1.35 ; p = 0.85 ) or per protocol analysis ( HR 0.87 , 95 % CI 0.61 to 1.24 ; p = 0.45 ) .
CONCLUSIONS	HSV-2 infection was common in the study population as detected by type-specific Elisa testing .
CONCLUSIONS	Provision of diaphragm and lubricant gel offered no additional protection against HSV-2 acquisition over male condoms alone .

###12600857
BACKGROUND	Food fortification with folic acid has been introduced in several countries for the prevention of neural tube defects .
BACKGROUND	Fortification has lowered total homocysteine ( tHcy ) concentrations in the US population , a consequence that may have health benefits .
BACKGROUND	However , folic acid fortification could mask vitamin B-12 deficiency .
BACKGROUND	Synthetic L-5-methyltetrahydrofolate ( L-MTHF ) may be more appropriate than folic acid as a fortificant because it is unlikely to mask the hematologic indicators of vitamin B-12 deficiency .
OBJECTIVE	The objective of the study was to compare the effectiveness of 100 micro g folic acid/d with that of equimolar L-MTHF in lowering tHcy in healthy volunteers .
METHODS	The study was designed as a 24-wk , randomized , placebo-controlled intervention .
METHODS	Free-living healthy volunteers ( n = 167 ) were randomly assigned to receive a daily supplement containing folic acid ( 100 microg ) , L-MTHF ( 113 microg ) , or placebo .
METHODS	Blood collected at baseline and at 8 , 16 , and 24 wk was analyzed for tHcy , plasma folate , and red blood cell folate ( RCF ) concentrations .
RESULTS	At 24 wk , after adjustment for baseline values , mean ( 95 % CI ) tHcy was 14.6 % ( 9.3 , 19.5 % ) and 9.3 % ( 3.7 , 14.6 % ) lower , mean plasma folate was 34 % ( 14 , 56 % ) and 52 % ( 30 , 78 % ) higher , and mean RCF was 23 % ( 12 , 35 % ) and 31 % ( 19 , 44 % ) higher in the L-MTHF and folic acid groups , respectively , than in the placebo group .
RESULTS	L-MTHF was more effective than was folic acid in lowering tHcy ( P < 0.05 ) .
RESULTS	At 24 wk , the increases in plasma folate and RCF concentrations did not differ significantly between the 2 supplemented groups .
CONCLUSIONS	Low-dose L-MTHF is at least as effective as is folic acid in reducing tHcy concentrations in healthy persons .

###22009510
OBJECTIVE	To evaluate the efficacy of transcutaneous electrical nerve stimulation ( TENS ) for decreasing pain related with office endometrial biopsy .
METHODS	In this prospective study , 65 women undergoing office endometrial biopsy were randomly allocated to receive 550 mg oral naproxen sodium plus active TENS ( Group I , n = 33 ) or 550 mg oral naproxen sodium plus placebo TENS ( Group II , n = 32 ) .
METHODS	The intensity of pain perceived by the patients was measured using a 10-cm visual analog scale ( VAS ) before insertion of the speculum , when the cervix grasped , immediately after biopsy , and 15 min after the procedure .
METHODS	The effect of anxiety ( Spielberger 's state anxiety inventory ) on pain scores was also investigated .
RESULTS	There were no statistical significant differences between groups in age , weight , body mass index , gravidity , parity , education , and menopausal status ( p > 0.05 ) .
RESULTS	The pain scores before insertion of the speculum , when the cervix grasped , and immediately after biopsy were similar in both groups ( p > 0.05 ) .
RESULTS	But at 15 min after the procedure , there was a significant reduction of the mean VAS pain score in naproxen sodium plus TENS group , compared with the naproxen sodium plus placebo TENS group ( 0.14 0.47 , 1.44 1.37 , respectively , p < 0.0001 ) .
RESULTS	The mean anxiety scores were 48.19 6.71 and 45.85 6.22 in Group I and Group II , respectively .
RESULTS	We did not find any significant correlation between anxiety and VAS pain scores ( p > 0.05 ) .
CONCLUSIONS	TENS appears to be successful in decreasing pain only after the procedure undergoing office endometrial biopsy .
CONCLUSIONS	It can be used as a simple , cheap , safe , and effective pain relief method .

###16175842
OBJECTIVE	To explore the relative effectiveness of clinician-delivered vs family-supported interventions for children with chronic impairment after TBI .
METHODS	Randomized controlled clinical trial .
METHODS	Children aged 5-12 years in the chronic phase of their recovery were randomly assigned to the clinician-delivered or to the family-supported intervention group ; both samples received intensive services for 1 year ; physical outcome was measured by the SARAH scales , cognitive outcome by the WISC-III .
RESULTS	Parents in the family-supported intervention sample efficiently acquired the skills needed to deliver physical and cognitive interventions within the context of everyday routines of the child 's life at home ; family education level was not a factor .
RESULTS	Although both groups demonstrated improvements , only the children in the family-supported intervention group demonstrated statistically significant -- and clinically important -- improvements on both outcome measures .
CONCLUSIONS	This RCT provides compelling evidence for organizing cognitive and physical interventions and supports for children with TBI around the everyday routines of their lives , with intensive supports for their families .

###17368247
OBJECTIVE	Minimally invasive surgery aims to achieve at least a similar clinical effectiveness with a quicker recovery than traditional open techniques .
OBJECTIVE	Although there have been numerous randomized clinical trials comparing laparoscopic hysterectomy with hysterectomy by laparotomy , only a few studies have compared quality of life after different types of hysterectomy .
OBJECTIVE	None of these studies evaluated total laparoscopic hysterectomy .
OBJECTIVE	In this paper , we report on a randomized comparison of quality of life after total laparoscopic versus total abdominal hysterectomy .
METHODS	Randomized , controlled trial ( Canadian Task Force classification I ) .
METHODS	Single-center teaching hospital in The Netherlands .
METHODS	Patients scheduled for hysterectomy for a benign condition , in whom a vaginal hysterectomy was not possible and laparoscopic hysterectomy was feasible ( mobile uterus not exceeding the size of 18 weeks ' gestation ) .
METHODS	Abdominal versus laparoscopic hysterectomy .
RESULTS	Patients completed the Dutch version RAND-36 health survey preoperatively as well as at 5 time points in the first 12 weeks after surgery .
RESULTS	The primary outcome of the study was quality of life as measured by the RAND-36 .
RESULTS	A linear mixed model was used for statistical analysis while accounting for baseline values .
RESULTS	Secondary outcomes were hospital stay and complications .
RESULTS	There were 88 patients eligible , of whom 59 gave consent for randomization .
RESULTS	Twenty-seven women were allocated to the laparoscopic arm and 32 to the abdominal arm .
RESULTS	We found a significant treatment effect favoring laparoscopic hysterectomy in the RAND-36 scale for vitality .
RESULTS	Laparoscopic hysterectomy performed better on all other scales of the RAND-36 , but these differences were not statistically significant .
CONCLUSIONS	Laparoscopic hysterectomy results in more postoperative vitality when compared with abdominal hysterectomy .
CONCLUSIONS	For this reason , all women with a benign condition requiring abdominal hysterectomy , in whom the laparoscopic approach is feasible , should have the chance to choose laparoscopic hysterectomy .

###17184645
BACKGROUND	To evaluate the impact of the genetic polymorphisms affecting aspirin response using platelet aggregation and the response to different aspirin doses after cardiopulmonary bypass , we performed a subanalysis of the results from a randomized trial evaluating low - and medium-dose aspirin and clopidogrel .
METHODS	Blood was collected from consenting patients and DNA extracted .
METHODS	Polymerase chain reaction and restriction fragment length polymorphism analysis was performed to detect Pl ( A2 ) , C807T , and A842/C50T polymorphisms .
METHODS	Aspirin efficacy was assessed using light transmission platelet aggregometry , and reported as percentage aggregation and EC50 concentrations using the technique of Born .
RESULTS	Of 90 patients , 80 consented to further genetic testing , of whom 63 patients were randomly assigned to medium - ( 325 mg ) or low-dose ( 100 mg ) aspirin .
RESULTS	The Pl ( A2 ) , C807T , and A842/C50T gene frequencies were 30 % , 66 % , and 21 % , respectively , with no identifiable differences in the baseline platelet aggregation .
RESULTS	Postoperatively , after 5 days of aspirin , platelet aggregation was consistently but not significantly impaired with Pl ( A2 ) and A842/C50T carriers and consistently but not significantly improved with C50T carriers .
RESULTS	An interaction term was identified on percentage aggregation and EC50 using epinephrine .
RESULTS	The interaction coefficient describes a higher aggregation of 19 % ( 95 % confidence interval : 2 to 36 ; p = 0.03 ) and less inhibition with an EC50 of -2.07 ( -4.19 to 0.04 ; p = 0.06 ) in patients who were both Pl ( A2 ) positive and receiving low-dose aspirin .
CONCLUSIONS	Genetic polymorphisms that affect the response to aspirin are common .
CONCLUSIONS	The impaired response of persons with the Pl ( A2 ) polymorphism to aspirin may be dose related , with significant improvement observed in patients using medium - rather than low-dose aspirin .

###24361804
BACKGROUND	There are no data regarding the effect of weight loss on clinical outcomes in patients undergoing cardiac resynchronization therapy .
BACKGROUND	This study was designed to evaluate the effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy with defibrillator ( CRT-D ) .
RESULTS	The risk of heart failure ( HF ) or death , and of death alone , was compared between patients with and without weight loss of 2 kg or more at 1 year in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) .
RESULTS	Weight loss was observed in 170 of 994 patients ( 17 % ) implanted with a CRT-D .
RESULTS	Multivariate analysis showed a significant increase in the risk of HF or death among patients with weight loss compared with those without weight loss ( hazard ratio [ HR ] 1.82 , 95 % confidence interval [ CI ] 1.26-2 .63 ; P = .001 ) .
RESULTS	Weight loss was associated with a 79 % increase in the risk of all-cause mortality ( HR 1.79 , 95 % CI 1.16-3 .34 ; P = .01 ) .
RESULTS	When analyzed in a continuous fashion , each kg of weight loss was associated with a 4 % increase in the risk of HF or death ( P = .03 ) .
RESULTS	In left bundle branch block ( LBBB ) patients with a CRT-D , weight loss was associated with an especially high risk of HF or death ( HR 2.23 , 95 % CI 1.36-3 .65 ; P = .002 ) and of death alone ( HR 2.33 , 95 % CI 1.07-5 .06 ; P = .03 ; interaction P = .26 ) .
CONCLUSIONS	In patients with mild symptoms of HF receiving CRT-D , weight loss observed at 1 year is associated with adverse clinical outcomes , especially in those with a LBBB electrocardiographic pattern .

###19364290
OBJECTIVE	The aim of this study was to examine the prevalence of activation cluster adverse events ( AC-AEs ) in youths treated with the selective serotonin reuptake inhibitor ( SSRI ) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels .
METHODS	Data from the Research Units on Pediatric Psychopharmacology ( RUPP ) Anxiety Study were examined for 45 youths ( 22 active fluvoxamine , 23 placebo ) treated for Diagnostic and Statistical Manual for Mental Disorders , 4 ( th ) edition ( DSM-IV ) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule .
METHODS	As part of the double-blind placebo-controlled trial , AC-AEs were recorded by clinicians at weekly patient visits .
METHODS	AC-AEs were defined as hyperactivity , activation , and disinhibition .
METHODS	Demographic characteristics , daily doses , and week-8 blood levels were examined in relation to the presence of AC-AEs .
METHODS	The prevalence of AC-AE and time to first event were established for those who experienced this side effect .
RESULTS	AC-AEs were found in 10 of 22 participants ( 45 % ) receiving fluvoxamine and only 1 of 23 in the placebo group ( 4 % ) .
RESULTS	The onset of AC-AEs occurred from week 1 to week 8 , with the majority occurring at or before week 4 .
RESULTS	The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs ( n = 16 , t = -2.61 , p = 0.04 ) .
RESULTS	Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE .
CONCLUSIONS	AC-AEs were common side effects of fluvoxamine , often appeared during the first 8 weeks of treatment , and were associated with higher fluvoxamine blood levels .
CONCLUSIONS	Close monitoring for AC-AEs , not only when initiating SSRI treatment but also throughout dose titration , is recommended for early identification of activation .

###21636144
BACKGROUND	Diabetes mellitus is associated with a high risk for heart failure , which is further increased in the presence of coronary heart disease .
BACKGROUND	So far no clinical risk score for development of heart failure exists for patients with type 2 diabetes and macrovascular disease .
METHODS	Independent clinical predictors for heart failure events were identified by Cox regression in a post-hoc analysis of the PROactive trial and were used for calculating a risk prediction score .
RESULTS	233 of 4951 patients with available baseline data suffered a serious adverse heart failure event during a mean follow-up of 34.5 ( 2.3 ) months .
RESULTS	Age , renal dysfunction , diuretic use , HbA1c , duration of diabetes , LDL-cholesterol , heart rate , right and left bundle branch block , microalbuminuria , previous myocardial infarction and pioglitazone treatment were independent predictors of heart failure .
RESULTS	The risk score showed a good calibration and moderate discrimination ( AUC 0.75 ) .
RESULTS	Patients were accurately stratified with an actual risk of 1.0 % , 3.2 % and 9.7 % in the bottom , middle and top tertile of the score , respectively , with corresponding hazard ratios of 3.5 ( 95 % CI 2.0-6 .2 ) and 10.5 ( 95 % CI 6.3-17 .6 ) for the middle and top tertile compared to the bottom tertile ( both p < 0.0001 ) .
RESULTS	The score stratified well in subgroups defined by pioglitazone treatment , prior myocardial infarction , obesity , poor glycemic control and microalbuminuria .
CONCLUSIONS	A risk score based on routinely assessed clinical variables proved a good stratification for future heart failure events in diabetic patients with macrovascular disease .
CONCLUSIONS	Strategies targeting specific interventions and monitoring of high risk patients need further evaluation .

###16169582
BACKGROUND	To improve follow-up compliance after an initial inadequate or abnormal cervical smear , two follow-up guidance systems were tested for effectiveness .
BACKGROUND	A comprehensive system ( cytopathology laboratory monitored the follow-up of all abnormal and inadequate smears ) was compared to a selective system ( monitoring was left to the smear taker ; laboratory acted as a safety net ) .
METHODS	In an RCT on all family practices ( N = 171 ) in the catchment areas of two cytopathology laboratories ( Nijmegen region , The Netherlands , 1998-2000 ) , practices were allocated at random to one of the follow-up guidance systems .
METHODS	All women included were registered at the practices , invited to the national screening program and had abnormal or inadequate smears .
METHODS	Measurements comprised of ( 1 ) follow-up compliance at baseline and 1 year after the initial smear and ( 2 ) diagnostic outcome of the follow-up smear .
RESULTS	During the study period , 132 practices sent their cervical smears to the laboratories .
RESULTS	The comprehensive system covered 1226 women , the selective 1034 .
RESULTS	In the comprehensive system , the increase in follow-up compliance for initial inadequate and slightly abnormal smears was significantly higher ( 8.9 % ) than in the selective one , which implied an extra detection of eleven , more serious , abnormalities per 1000 women .
CONCLUSIONS	The comprehensive system was more effective than the selective and is suitable for use on a larger scale .

###19543672
OBJECTIVE	The aim of the present study was to evaluate the safety of methylphenidate administered during inpatient rehabilitation following traumatic brain injury .
METHODS	Forty inpatients with moderate-severe traumatic brain injury ( mean 68.4 days post-injury ) participated in a randomized , cross-over , double-blind , placebo-controlled trial of methylphenidate administered at a dose of 0.3 mg/kg body weight twice daily .
RESULTS	Methylphenidate administration resulted in a statistically significant increase in pulse of 12.3 beats/min ( 95 % confidence interval ( CI ) 9.25-15 .36 ) , diastolic blood pressure of 4.1 mmHg ( 95 % CI 2.11-6 .10 ) , and mean arterial pressure of 3.75 mmHg ( 95 % CI 1.79-5 .72 ) .
RESULTS	These changes did not , however , appear to be symptomatic , as no participants were withdrawn due to adverse events , and there was no significant self-report of increased heart rate with methylphenidate .
RESULTS	Blinding was successful .
RESULTS	Significantly greater reporting of irritability of 0.14 points ( 95 % CI 0.02-0 .26 ) , difficulty sleeping of 0.17 points ( 95 % CI 0.02-0 .31 ) and total side-effects of 0.68 points ( 95 % CI 0.06-1 .30 ) was associated with methylphenidate compared with placebo .
CONCLUSIONS	Methylphenidate given at 0.3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase .
CONCLUSIONS	This trial is registered with the Australian New Zealand Clinical Trials Registry ( 12607000503426 ) .

###17675321
BACKGROUND	Airway obstruction in acute asthma is the result of airway smooth muscle contraction , inflammation and mucus plugging .
BACKGROUND	Case reports suggest that mucolytic therapy might be beneficial in acute asthma .
BACKGROUND	The aim of this study was to determine the efficacy of the mucolytic drug recombinant human deoxyribonuclease ( rhDNase ) in addition to standard treatment at the emergency department in children with an asthma exacerbation .
METHODS	In a multicentre randomised double-blind controlled clinical trial , 121 children brought to the emergency room for a moderate to severe asthma exacerbation were randomly assigned to receive either a single dose of 5 mg nebulised rhDNase or placebo following the second dose of bronchodilators .
METHODS	An asthma score ( scale 5-15 ) was assessed at baseline and at 1 , 2 , 6 , 12 and 24 h.
METHODS	The primary outcome variable was the asthma score 1 h after the study medication .
RESULTS	One hour after the study medication the asthma score in the rhDNase group showed an adjusted mean decrease from baseline of 1.0 ( 95 % CI 0.5 to 1.6 ) points compared with 0.7 ( 95 % CI 0.3 to 1.2 ) points in the placebo group ( mean difference 0.4 ( 95 % CI -0.2 to 1.0 ) points ; p = 0.23 ) .
RESULTS	The asthma score over the study period of 24 h also did not differ significantly between the rhDNase and placebo group ( mean difference 0.2 ( 95 % CI -0.3 to 0.7 ) points , p = 0.40 ) .
RESULTS	The duration of oxygen supplementation and number of bronchodilator treatments in the first 24 h were similar in both groups .
CONCLUSIONS	Adding a single dose of nebulised rhDNase to standard treatment in the emergency room has no beneficial effects in children with moderate to severe acute asthma .

###8622072
OBJECTIVE	A randomized trial was conducted to compare tumorectomy and breast irradiation with modified radical mastectomy .
OBJECTIVE	We have analyzed the patterns of failure in each arm of the trial and the prognostic factors that have an independent effect on treatment failures and overall survival .
METHODS	The trial included 179 patients with breast cancer of up to 20 mm in diameter at macroscopic examination .
METHODS	Eighty-eight patients had conservative management and 91 a mastectomy .
METHODS	All patients had axillary dissection with frozen-section examination .
METHODS	For patients with positive axillary nodes ( N + ) , a second randomization was performed : lymph node irradiation versus no further regional treatment .
METHODS	Patterns of failure were determined by a competing-risk approach and multivariate analysis .
METHODS	A prognostic-score was determined by multivariate analysis .
RESULTS	Overall survival , distant metastasis , contralateral breast cancer , new primary malignancy , and locoregional recurrence rates were not significantly different between the two surgical groups , or between lymph node irradiation groups .
RESULTS	Most recurrences appeared during the first 10 years .
RESULTS	Three distinct prognostic groups were determined taking into account age , tumor size , histologic grading , and number of positive axillary nodes .
CONCLUSIONS	Long-term results support conservative treatment with limited surgery and systematic breast irradiation as a safe procedure for the management of small breast cancers .
CONCLUSIONS	Four easily obtainable clinical and histologic factors may be combined in a prognostic score that is highly predictive of overall and event-free survival .

###8990451
OBJECTIVE	To investigate whether the incidence of persistent ectopic pregnancy after linear salpingostomy can be reduced by prophylactic administration of a single dose of methotrexate postoperatively .
METHODS	Women who underwent linear salpingostomy for treatment of unruptured ectopic pregnancy and who agreed to participate in the study ( n = 129 ) were randomly assigned to the prophylaxis or control group .
METHODS	Women with anemia , renal insufficiency , or liver disease were excluded .
METHODS	In the prophylaxis group , patients received a single dose of methotrexate , 1 mg/kg intramuscularly , within 24 hours postoperatively .
METHODS	No treatment was used in the control group .
METHODS	Both groups were followed with serial serum beta-hCG titers ; titers were measured on the seventh postoperative day , then every 72 hours until levels were lower than 15 mIU/mL .
METHODS	A blood count and chemistry panel were also obtained on postoperative day 7 , and any side effects related to methotrexate were noted .
METHODS	Persistent ectopic pregnancy was defined as a rise in the serum beta-hCG level or a decline of less than 20 % between two consecutive measurements taken 3 days apart .
RESULTS	A total of 116 women completed the postoperative follow-up : 54 in the prophylaxis group and 62 in the control group .
RESULTS	Ten women had persistent ectopic pregnancy , one in the prophylaxis group ( 1.9 % ) and nine among the controls ( 14.5 % ) ; this difference was statistically significant ( P < .05 ) .
RESULTS	The relative risk of developing persistent ectopic pregnancy after prophylactic methotrexate was 0.13 ( 95 % confidence interval 0.02 , 0.97 ) .
RESULTS	Three women ( 5.5 % ) reported mild side effects after methotrexate , but these resolved spontaneously .
CONCLUSIONS	The incidence of persistent ectopic pregnancy was significantly reduced after a single prophylactic dose of systemic methotrexate administered postoperatively .
CONCLUSIONS	This regimen is safe and can be used to decrease the extent of postoperative monitoring after conservative treatment of unruptured ectopic pregnancy .

###11696746
OBJECTIVE	We compared ambulatory urodynamics and conventional video cystometry findings in women with symptoms of bladder overactivity .
METHODS	In a prospective randomized crossover study 106 women with symptoms of urinary urgency with or without incontinence were comprehensively investigated by video cystometry and ambulatory urodynamics in random order .
METHODS	In addition , all women completed a validated symptoms questionnaire and voiding diary .
RESULTS	Involuntary detrusor activity was detected in 32 and 70 cases on video cystometry and ambulatory urodynamics , respectively ( p < 0.001 ) .
RESULTS	Video cystometry done according to International Continence Society standards diagnosed detrusor instability in 4 women with no involuntary detrusor activity on ambulatory urodynamics .
RESULTS	Involuntary detrusor activity resulting in incontinence was observed in 39 cases on ambulatory urodynamics , including 20 ( 51 % ) with stable video cystometry results .
RESULTS	Stress incontinence was diagnosed in 42 cases on video cystometry and in 34 on ambulatory urodynamics ( p = 0.629 ) .
RESULTS	Increasingly severe urge and stress incontinence reported in the symptoms questionnaire correlated positively with the subsequent detection of detrusor overactivity and stress incontinence , respectively , on the 2 urodynamic tests .
CONCLUSIONS	In contrast to video cystometry , ambulatory urodynamics provides objective evidence of clinically important bladder overactivity in the majority of women with symptoms suggestive of bladder overactivity .
CONCLUSIONS	The correlation of symptoms with ambulatory urodynamic findings implies that greater reliance may be placed on symptomatic diagnosis of bladder overactivity .
CONCLUSIONS	Improved objective assessment of detrusor function provided by ambulatory urodynamics has implications for the definition of bladder overactivity and relevance of conventional cystometry in this context .
CONCLUSIONS	In women who complain of urgency stable conventional cystometrography findings should be interpreted with caution .

###22177437
OBJECTIVE	To investigate the effects of ulinastatin ( Uti ) and low-molecular-weight heparin ( Lmwh ) on coagulation function and deep vein thrombosis ( DVT ) in patients undergoing hip joint replacement .
METHODS	From March to December 2010 150 ASAI-II patients with average age of 72.5 ( 65 - 85 ) years undergoing hip joint replacement were randomly divided into 3 groups ( n = 50 each ) : normal saline ( NS ) control group ( Group C ) , Uti group ( Group U ) and Lmwh group ( Group L ) .
METHODS	Group U received intravenous infusion of ulinastatin ( 10 000 U/kg ) at preoperative , perioperative and after operation 1 , 2 and 3 d , respectively .
METHODS	Group C received the same volume of NS instead of Uti .
METHODS	Group L were injected Lmwh subcutaneously ( 3200 U/d ) at preoperative , after operation 1 , 2 and 3 d. Blood samples were taken before operation ( T ( 0 ) ) , at the end of surgery ( T ( 1 ) ) , 1 d ( T ( 2 ) ) , 2 d ( T ( 3 ) ) and 3 d ( T ( 4 ) ) after operation for determination the values of R , K , angle , MA and CI , using thromboelastography , and the DVT were also examined through color Doppler ultrasonography at 3 d after operation .
RESULTS	Compared with T ( 0 ) , R , K were shorter , angle , MA and CI were larger in group C , the values at T ( 2 ) were up to the peak then declined at T ( 4 ) .
RESULTS	Compared with group C , the value of R , K were larger , the value of angle , MA and CI were shorter in group U and group L.
RESULTS	The DVT checked by ultrasonography were found in 20 cases in group C , 1 case in group U , and zero case in group L.
RESULTS	The differences were no statistically significant between group U and group L.
CONCLUSIONS	Intravenous infusion of Uti during the period of operation can correct the hypercoagulability of blood and decrease the incidence of DVT after operation .

###18158289
OBJECTIVE	The aim of this study is to investigate whether the benefit of abciximab in patients with non-ST-segment elevation acute coronary syndromes ( NSTE-ACSs ) undergoing percutaneous coronary intervention ( PCI ) after pre-treatment with 600 mg clopidogrel is sustained at 1 year .
RESULTS	We performed 1-year follow-up of 2022 high-risk patients with NSTE-ACS undergoing urgent PCI , who were randomized to abciximab or placebo after pre-treatment with 600 mg clopidogrel in the Intracoronary Stenting and Antithrombotic Regimen : Rapid Early Action for Coronary Treatment 2 trial .
RESULTS	The combined incidence of death , myocardial infarction , or target vessel revascularization at 1 year was the primary outcome analysis .
RESULTS	At 1 year , the primary outcome was reached in 23.3 % of patients allocated to abciximab vs. 28.0 % of patients allocated to placebo [ relative risk ( RR ) 0.80 , 95 % confidence interval ( CI ) 0.67-0 .95 , P = 0.012 ] .
RESULTS	The combined incidence of death or myocardial infarction was 11.6 % in patients allocated to abciximab vs. 15.3 % in patients allocated to placebo ( RR 0.74 , 95 % CI 0.59-0 .94 , P = 0.015 ) .
CONCLUSIONS	In high-risk patients with NSTE-ACS undergoing a PCI after pre-treatment with 600 mg clopidogrel , adverse events occurred less frequently with abciximab and the early benefit was maintained at 1 year after administration .

###23395102
BACKGROUND	Sarcopenia is prevalent in older populations with many causes and varying outcomes however information for use in clinical practice is still lacking .
OBJECTIVE	The aim of this report is to identify the clinical determinants and prognostic significance of sarcopenia in a cohort of hospitalized acutely ill older patients .
METHODS	Four hundred and thirty two randomly selected patients had their baseline clinical characteristic data assessed within 72h of admission , at 6 weeks and at 6 months .
METHODS	Nutritional status was assessed from anthropometric and biochemical data .
METHODS	Sarcopenia was diagnosed from low muscle mass and low muscle strength-hand grip using anthropometric measures based on the European Working Group criteria .
RESULTS	Compared with patients without sarcopenia , those diagnosed with sarcopenia 44 ( 10 % ) were more likely to be older , have more depression symptoms and lower serum albumin concentration .
RESULTS	The length of hospital stay ( LOS ) was significantly longer in patients diagnosed with sarcopenia compared with patients without sarcopenia [ mean ( SD ) LOS 13.4 ( 8.8 ) versus 9.4 ( 7 ) days respectively , p = 0.003 ] .
RESULTS	The risk of non-elective readmission in the 6 months follow up period was significantly lower in patients without sarcopenia compared with those diagnosed with sarcopenia ( adjusted hazard ratio .53 ( 95 % CI : .32 to .87 , p = 0.013 ) .
RESULTS	The death rate was also lower in patients without sarcopenia 38/388 ( 10 % ) , compared with those with sarcopenia 12/44 ( 27 % ) , p-value = .001 .
CONCLUSIONS	Older people with sarcopenia have poor clinical outcome following acute illness compared with those without sarcopenia .

###17985560
BACKGROUND	We describe a new principle for enhancing the effects of sensory re-education following nerve injury and repair .
BACKGROUND	The outcome from nerve repair in adult patients is generally poor .
BACKGROUND	One reason is the functional cortical reorganisation which always occurs because of axonal misdirection at the repair site .
BACKGROUND	In healthy individuals selective anaesthesia of the forearm results in improved hand sensation .
BACKGROUND	Here we hypothesised that this principle would be valid also after nerve injury and repair .
METHODS	In a prospective , randomised , double blind study we studied the effects of cutaneous forearm anaesthesia combined with sensory reeducation on the outcome after median or ulnar nerve repair at wrist or distal forearm level .
RESULTS	EMLA-application four times over a two week period starting with beginning reinnervation of the fingers resulted in significantly improved sensory recovery ( tactile gnosis ) as compared to the placebo group and also at assessment four weeks after the last EMLA-session .
RESULTS	However , at assessment 8-11 months after the first EMLA-treatment there was no difference between the groups .
CONCLUSIONS	Our findings indicate that repeated cutaneous forearm anaesthesia over a two week period can enhance the effects of sensory re-education at least over the four following weeks .
CONCLUSIONS	However , the optimal time protocol for EMLA-treatment , aiming at a long-lasting or permanent effect on sensory recovery still has to be defined .

###16002806
BACKGROUND	Single-meal studies have established that calcium has an acute inhibitory effect on the absorption of iron .
BACKGROUND	However , there is growing evidence that high calcium intakes do not compromise iron status .
OBJECTIVE	We evaluated whether long-term calcium supplementation taken with the main meal affected biomarkers of iron status in adolescent girls with high requirements of both iron and calcium .
METHODS	The study was a randomized , double-blind , placebo-controlled trial of supplementation with 500 mg Ca/d for 1 y among 113 adolescent girls aged 13.2 + / - 0.4 y at enrollment .
METHODS	Participants were advised to take the supplement with their evening meal , which usually contributes the majority of dietary iron .
METHODS	Iron status was assessed at baseline and after 1 y of supplementation by measuring hemoglobin and serum concentrations of ferritin and transferrin receptors ( TfRs ) .
RESULTS	The mean ( + / - SD ) hemoglobin at enrollment was 134 + / - 9 g/L , geometric mean serum ferritin was 26.3 microg/L ( interquartile range : 18.6-39 .4 microg/L ) , and serum TfR was 4.19 mg/L ( 3.52-5 .10 mg/L ) .
RESULTS	Daily calcium supplementation had no effect on the least-squares mean concentrations of iron-status markers adjusted for their baseline values ( hemoglobin : 136 and 134 g/L , P = 0.31 ; ferritin : 25.4 and 26.1 microg/L , P = 0.73 ; TfR : 4.1 and 4.4 mg/L , P = 0.12 ; and the ratio of TfR to ferritin : 160 and 161 in the calcium and placebo groups , respectively ; P = 0.97 ) .
CONCLUSIONS	Although it remains to be shown in iron-deficient persons , long-term iron status does not seem to be compromised by high calcium intakes .

###15584057
BACKGROUND	Severe chronic pain is a long-term problem that may occur after inguinal hernia repair .
BACKGROUND	The aim of this randomized study was to compare pain of any severity at 12 months after inguinal hernia repair with a partially absorbable lightweight mesh ( LW group ) or with a non-absorbable heavyweight mesh ( HW group ) .
METHODS	Patients were assessed for pain at 1 , 3 and 12 months by questionnaire , and were examined clinically at 12 months .
RESULTS	Some 321 patients were included in an intention-to-treat analysis , 162 in the LW group and 159 in the HW group .
RESULTS	At 12 months , significantly fewer patients in the LW group than in the HW group had pain of any severity : 39.5 versus 51.6 per cent ( difference-12 .1 ( 95 per cent confidence interval-23 .1 to-1 .0 ) per cent ; P = 0.033 ) .
RESULTS	The recurrence rate was higher in the LW group ( 5.6 versus 0.4 per cent ; P = 0.037 ) .
RESULTS	Five of eight recurrences in LW group were associated with a single participating centre .
CONCLUSIONS	Use of lightweight mesh was associated with less chronic pain but an increase in hernia recurrence after inguinal hernia repair .
CONCLUSIONS	The latter may be related to technical factors associated with fixation of such meshes rather than any inherent defect in the mesh .

###9881552
OBJECTIVE	This study was planned to investigate the penetration of ciprofloxacin into aqueous humor following oral and topical application as a prophylactic antimicrobial agent .
METHODS	Forty-six patients undergoing cataract surgery were randomly divided into two groups .
METHODS	In the first group , the patients received 500 mg oral ciprofloxacin eight hours before surgery and in the second , 5 drops of 0.3 % ciprofloxacin were applied to the patients every twenty minutes , starting 100 minutes before the surgery .
METHODS	By paracentesis , aqueous samples were taken just before the operation so the interval between the first topical application and paracentesis was 100 minutes .
RESULTS	The mean concentration of ciprofloxacin in aqueous humor was 0.63 + / -0.29 microg/ml in the first group .
RESULTS	The concentration was 0.69 + / -0.30 microg/ml in the second group .
RESULTS	Both of these mean concentrations were higher than the levels of MIC90 of S.aureus , S. epidermidis , P. aeruginosa and Gram ( - ) bacteriae .
CONCLUSIONS	As a result , both topically and orally applied ciprofloxacin achieved a significant aqueous concentration .
CONCLUSIONS	Each route studied might be suitable for surgical prophylaxis or treatment of infections .

###20105036
OBJECTIVE	Prior research had shown that an additional training session immediately after acute stress increased release of salivary secretory immunoglobin A ( sIgA ) in a group trained with 5-day Integrative Body-Mind Training ( IBMT ) in comparison to a control group given the same amount of relaxation training .
OBJECTIVE	However , 5 days of training did not influence the basal secretion of sIgA .
OBJECTIVE	The current study seeks to extend this finding and determine whether increasing amounts of IBMT will increase the basal sIgA level , suggesting further improvements in mucosal immune function .
METHODS	Thirty-five ( 35 ) Chinese undergraduates were randomly assigned either to an experimental group receiving 4 weeks of IBMT or a relaxation control .
METHODS	Salivary sIgA levels at baseline before training and three stages ( i.e. , rest , stress , and additional 20-minute practice ) after 2 and 4 weeks training were assessed .
RESULTS	The basal sIgA levels increased significantly in the experimental subjects but not in controls after 4 weeks of training .
RESULTS	An additional IBMT practice session immediately after acute stress produced significantly higher sIgA release for the IBMT-trained group in comparison with controls at week 2 and 4 .
RESULTS	This effect was larger at week 4 than week 2 .
CONCLUSIONS	These results indicate that the IBMT produces a change in the basal immune system and larger acute effects as the dose of training increases .

###12489980
OBJECTIVE	To assess the dose proportionality of lacidipine after single and repeated oral doses , and to obtain new information on the pharmacokinetics of the compound since improvement of the plasma assay method .
METHODS	Open , randomised , four-way cross-over trial .
METHODS	24 healthy male and female volunteers , aged 18-46 years .
METHODS	Lacidipine was administered as single doses of 2 , 4 , 6 and 8 mg , and as multiple doses of 2 , 4 and 6 mg for 8 days .
METHODS	Pharmacokinetic evaluations were performed on study days 1 and 8 .
METHODS	Plasma concentrations of lacidipine were determined by a validated high-performance liquid chromatography-radioimmunoassay method .
METHODS	The ratios of dose-normalised peak plasma concentration ( C ( max ) ) and area under the concentration-time curve ( AUC ) were calculated and then compared across dose groups by analysis of variance to assess dose linearity against a 4 mg reference dose .
METHODS	A power model was also applied as an alternative method for the evaluation of linearity .
RESULTS	After repeated 2 , 4 and 6 mg doses of lacidipine , geometric least square mean values ( 95 % CI ) were 1.76 ( 1.46-2 .12 ) , 3.56 ( 2.96-4 .29 ) and 5.23 ( 4.34 -- 6.30 ) microg/L for C ( max ) and 5.29 ( 4.57-6 .11 ) , 11.42 ( 9.87-13 .20 ) and 17.55 ( 15.18-20 .29 ) microg x h/L for AUC over the administration interval at steady state ( AUC ( tau ) ) , respectively .
RESULTS	Mean half-life ranged between 13.2 hours and 18.7 hours .
RESULTS	Precision of these estimates was limited by the small number of sampling timepoints collected in the final part of the curve .
RESULTS	After administration of single doses , no statistically significant deviation from linearity was found except for the 8 mg dose , but a trend of greater than proportional exposure was evident with increasing dose .
RESULTS	Following repeated administration , dose linearity over the therapeutic range was observed .
RESULTS	No statistically significant difference was observed between AUC to infinity ( AUC ( infinity ) ) on day 1 and AUC ( tau ) on day 8 , suggesting time-invariance of pharmacokinetics .
CONCLUSIONS	Lacidipine exhibited linear kinetics after repeated doses in the therapeutic range of 2-6 mg once daily .
CONCLUSIONS	The two different methodologies for assessing linearity gave consistent results .
CONCLUSIONS	Only the single 8 mg dose , which is outside the recommended therapeutic range , resulted in greater than predicted exposure .
CONCLUSIONS	After low doses , the analytical method still does not allow complete characterisation of kinetics .
CONCLUSIONS	Time-invariance of lacidipine kinetics is suggested .

###21466598
BACKGROUND	Rapeseed oil ( RO ) , also known as canola oil , principally contains the unsaturated fatty acids 18:1 n-9 , 18:2 n-6 and 18:3 n-3 and may promote cardiometabolic health .
OBJECTIVE	To investigate the effects on lipoprotein profile , factors of coagulation and insulin sensitivity of replacing a diet rich in saturated fat from dairy foods ( DF diet ) with a diet including RO-based fat ( RO diet ) .
METHODS	During a 23-week randomized , controlled , cross-over trial , 20 free-living hyperlipidaemic subjects were provided with isocaloric test diets that differed in fat composition alone .
METHODS	Blood lipoprotein profile , coagulation and fibrinolytic factors and insulin sensitivity ( euglycaemic clamp ) were determined before and after the dietary intervention .
RESULTS	All subjects completed the study , and compliance was high according to changes in serum fatty acids .
RESULTS	The RO diet , but not the DF diet , reduced the levels of serum cholesterol ( -17 % ) , triglycerides ( -20 % ) and low-density lipoprotein cholesterol ( -17 % ) , cholesterol/high-density lipoprotein ( HDL ) cholesterol ratio ( -21 % ) , apolipoprotein ( apo ) B/apo A-I ratio ( -4 % ) and factor VII coagulant activity ( FVIIc ) ( -5 % ) from baseline .
RESULTS	These changes were significantly different between the diets ( P = 0.05 to P < 0.0001 ) , except for FVIIc ( P = 0.1 ) .
RESULTS	The RO diet , but not the DF diet , modestly increased serum lipoprotein ( a ) ( +6 % ) and tended to increase the glucose disappearance rate ( K-value , +33 % ) .
RESULTS	HDL cholesterol , insulin sensitivity , fibrinogen and tissue plasminogen activator inhibitor-1 levels did not change from baseline or differ between the two diets .
CONCLUSIONS	In a diet moderately high in total fat , replacing dairy fat with RO causes a rapid and clinically relevant improvement in serum lipoprotein profile including lowering of triglycerides in hyperlipidaemic individuals .

###16508401
BACKGROUND	The mechanisms underlying neuropathic pain are incompletely understood .
BACKGROUND	Targeting specific molecular mechanisms in the pain signaling system may assist in understanding key features in neuropathic pains such as allodynia .
BACKGROUND	This study examined the effect of systemically administered ketamine , an N-methyl-D-aspartate receptor antagonist and lidocaine , a sodium channel blocker , on spontaneous pain , brush-evoked pain , and pinprick-evoked pain in patients with nerve injury pain .
METHODS	Twenty patients participated in two randomized , double-blinded , placebo-controlled , crossover experiments in which they , on four different days , received a 30-minute intravenous infusion of ketamine ( 0.24 mg/kg ) , lidocaine ( 5 mg/kg ) , or saline .
METHODS	Ongoing pain , pain evoked by brush and repetitive pinprick stimuli , and acetone was measured before , during , and after infusion .
RESULTS	Ketamine significantly reduced ongoing pain and evoked pain to brush and pinprick , whereas lidocaine only reduced evoked pain to repetitive pinprick stimuli .
RESULTS	In individual patients , there was no correlation between the pain-relieving effect of lidocaine and ketamine on ongoing or mechanically evoked pains .
CONCLUSIONS	N-methyl-D-aspartate receptor-linked systems and sodium channels are involved in generation and maintenance of pain in patients with peripheral nerve injury .
CONCLUSIONS	It is likely that ongoing pain as well as mechanical hyperalgesia in individual patients is dependent on several separate molecular mechanisms .

###12219064
OBJECTIVE	To investigate the efficacy and safety of polyethylene glycol ( PEG ) 3350 in the treatment of childhood fecal impaction .
METHODS	This was a prospective , double-blind , parallel , randomized study of 4 doses of PEG 3350 ; 0.25 g/kg per day , 0.5 g/kg per day , 1 g/kg per day , 1.5 g/kg per day , given for 3 days in children with constipation for > 3 months and evidence of fecal impaction .
RESULTS	Forty patients completed the study ( 27 boys , median age 7.5 , range 3.3-13 .1 years ) .
RESULTS	Disimpaction occurred in 75 % of children , with a significant difference between the two higher doses and the lower doses ( 95 % vs 55 % , P < .005 ) .
RESULTS	All groups had an increased number of bowel movements during the 5-day study versus baseline , respectively : 6.5 versus 1.1 ( P < .005 ) , 8.0 versus 1.3 ( P < .005 ) , 10.9 versus 1.7 ( P < .005 ) , and 12.3 versus 1.4 ( P < .005 ) .
RESULTS	Adverse effects included nausea ( 5 % ) , vomiting ( 5 % ) , bloating ( 18 % ) , cramping ( 5 % ) , and diarrhea ( 13 % ) .
RESULTS	Diarrhea and bloating were more prevalent ( P < .02 ) in the higher-dose than in the lower-dose group .
RESULTS	No clinically significant changes in electrolytes were noted .
CONCLUSIONS	The 3-day administration of PEG 3350 is safe and effective in the treatment of childhood fecal impaction at doses of 1 and 1.5 g/kg per day .

###22733398
BACKGROUND	Medicinal or surgical castration remains the treatment of choice in metastatic , hormone-naive prostate cancer ; however , 2-12 % of patients never reach the target serum levels for medicinal castration .
BACKGROUND	We analyzed the therapeutic efficacy of triptorelin pamoate ( TP ) as salvage treatment due to its higher potency than endogenous luteinizing hormone-releasing hormone ( LHRH ) .
BACKGROUND	The amino acid sequence of TP is identical to that of endogenous LHRH except for position 6 where L-glycine is replaced by D-tryptophane rendering the synthetic moiety less susceptible to cleavage by proteolytic enzymes .
METHODS	In this study 36 patients with prostate-specific antigen ( PSA ) progression following first line complete androgen blockade and antiandrogen ( ADT ) withdrawal were retrospectively analyzed .
METHODS	All patients demonstrated no or minimal metastatic disease .
METHODS	The PSA levels , PSA doubling time ( PSADT ) , PSA velocity ( PSAV ) and testosterone serum concentrations were correlated with the therapeutic response .
METHODS	All patients received TP at a dose of 11.5 mg at 3-month intervals until documented progression .
RESULTS	The mean patient age was 69.2 years ( range 52-79 years ) , the mean PSA level was 23.4 ng/ml ( 8.7-53 .1 ng/ml ) and the mean PSADT was 9.2 months ( 2.9-15 .4 months ) .
RESULTS	Mean testosterone serum concentration was 38.67 ng/dl ( 21-76ng / dl ) , the mean time between start of ADT and progression was 42.4 months ( 13-76 months ) and the median time was 46.8 months ( 16-82 months ) .
RESULTS	A PSA decrease of 50 % was reached in 9 out of 36 ( 25 % ) patients , 3 out of 36 ( 13.9 % ) patients each demonstrated stable PSA levels and a prolongation of PSADT from 6.2 to 9.8 months .
RESULTS	Mean progression-free survival ( PFS ) was 21.4 weeks ( 7-53 weeks ) .
RESULTS	PSA-responders exhibited a PFS of 53.2 weeks ( 26-64 weeks ) as compared to 28 weeks ( 17-35 weeks ) in nonresponders .
RESULTS	PSA responders demonstrated significantly higher testosterone serum concentrations of 48.3 ng/dl ( 29-76ng / dl ) as compared to nonresponders with 32.6 ng/dl ( 21-62ng / dl , p = 0.02 ) .
RESULTS	Mean follow-up was 31.4 months ( 27-39 months ) , overall survival was 80.5 % and cancer-specific survival was 88.9 % .
CONCLUSIONS	Changing the LHRH analogue in castration-refractory prostate cancer ( CRPC ) with testosterone serum concentrations at or above the castration level results in a temporary PSA response .
CONCLUSIONS	This treatment option might be included in the therapeutic algorithm of CRPC .
CONCLUSIONS	Although the PFS is short it allows the continuation of a treatment option with minimal side effects in a mere palliative situation .
CONCLUSIONS	The data underline the need for continuous monitoring of testosterone during treatment with LHRH analogues .

###19848209
OBJECTIVE	To evaluate the effect of treatment for tonifying qi , nourishing yin , activating blood circulation and removing stasis on insulin resistance ( IR ) in patients of type 2 diabetes mellitus ( T2DM ) complicated with hypertension .
METHODS	Forty-five patients of T2DM with hypertension enrolled from authors ' special clinics were equally randomized into two groups : the test group ( 20 patients ) and the control group ( 25 patients ) .
METHODS	Both groups received orally hypoglycemic drugs , such as glipizide sustained-release tablets , pioglitazone , and metformin , and antihypertensive drug as nifedipine sustained-release tablets as well .
METHODS	Additionally , Sanqidan Granules ( SQD ) , a Chinese patent medicine was given to the test group .
METHODS	The course of treatment lasted for 8 weeks .
METHODS	The clinical efficacy of Chinese medicine syndromes , blood pressure , T2DM related indices and blood lipids in the two groups were observed .
RESULTS	The effect in improving Chinese medicine syndromes in the test group was better than that in the control group significantly ( P < 0.05 ) .
RESULTS	After treatment , all the indices were examined , except FINS and TG were improved in the test group , showing significant difference as compared with those before treatment ; while in the control group , significant difference was only shown in terms of fasting blood glucose ( FBG ) , HbA1 c , systolic blood pressure ( SBP ) and HDL-C ( P < 0.01 ) .
RESULTS	Comparison between groups showed that the effect in the former was better than that in the latter group in terms of decreasing FBG , HbA1c , SBP and increasing of HDL-C ( P < 0.05 ) , while a downward trend of ISI in the test group was shown but with no statistical significance ( P = 0.230 ) .
CONCLUSIONS	SQD can relieve the clinical symptoms in patients of syndrome of qi-yin deficiency and inner blockage of blood stasis , increase the insulin sensitivity and reduce the IR in patients , so as to decrease their FBG , blood pressure and HbAlc .
CONCLUSIONS	It also can increase HDL-C level , and lower TC and LDL-C levels , which is beneficial to anti-atherosclerosis .

###16176203
OBJECTIVE	Fatigue is a common complaint in diabetic patients during periods of hyperglycaemia .
OBJECTIVE	To test whether muscle performance is reduced during acute hyperglycaemia , diabetic patients were studied whilst performing maximal isokinetic and isometric contractions .
METHODS	In this double-blind placebo controlled study , maximal isometric and isokinetic muscle strength was determined in seven Type 1 diabetic patients during normo - and hyperglycaemia using a hyperglycaemic clamp technique .
METHODS	On two separate days , maximal muscle strength of the knee extensors was determined quantitatively using a dynamometer .
METHODS	On both days , muscle strength was determined before a constant blood glucose level was obtained and after the blood glucose level had been kept constant at either 5 or 16 mmol/l for 3 h. Percentage of change from baseline at the two glycaemic levels were calculated and compared .
METHODS	In addition , the changes from baseline at these glycaemic levels were related to glucose turnover .
RESULTS	Following hyperglycaemia , a significant decrease in maximal isometric muscle strength was found as compared with normoglycaemia ( 86 vs. 104 % of the initial level ) ( P = 0.018 ) .
RESULTS	In contrast , no alteration of maximal isokinetic muscle strength was found comparing normo - and hyperglycaemia ( 96 and 95 % ) ( P = 0.74 ) .
RESULTS	Changes in muscle strength were not significantly related to either basal or hyperglycaemic glucose turnover .
CONCLUSIONS	A few hours of hyperglycaemia in Type 1 diabetic patients leads to a reduction of isometric muscle performance , whereas isokinetic muscle strength is unchanged .
CONCLUSIONS	The reduction in muscle strength could play a role in the development of fatigue and is related more closely to ambient glucose concentrations than to systemic glucose availability .

###19652072
OBJECTIVE	Sunitinib has demonstrated antitumor activity in metastatic renal cell carcinoma ( mRCC ) when given at 50 mg/d on a 4-weeks-on 2-weeks-off regimen .
OBJECTIVE	Herein , we report results of an open-label , multicenter phase II mRCC study of sunitinib administered on a continuous once-daily dosing regimen .
METHODS	Eligibility criteria included histologically proven mRCC with measurable disease , failure of one prior cytokine regimen , and good performance status .
METHODS	Patients were randomly assigned to a sunitinib starting dose of 37.5 mg/d in the morning ( AM ) or evening ( PM ) .
METHODS	RECIST-defined objective response rate ( ORR ) was the primary end point .
METHODS	Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , adverse events ( AEs ) , and quality-of-life measures .
RESULTS	One hundred seven patients were randomly assigned to AM ( n = 54 ) or PM ( n = 53 ) dosing and on study for a median 8.3 months .
RESULTS	Eighty-three patients discontinued , 65 due to disease progression and 16 because of AEs ; two patients withdrew consent .
RESULTS	Dosing was reduced to 25 mg/d in 46 patients ( 43 % ) due to grade 3/4 AEs .
RESULTS	The most common grade 3 treatment-related AEs were asthenia/fatigue ( 16 % ) , diarrhea ( 11 % ) , hypertension ( 11 % ) , hand-foot syndrome ( 9 % ) , and anorexia ( 8 % ) .
RESULTS	ORR was 20 % with a 7.2-month median response duration .
RESULTS	Median PFS and OS were 8.2 and 19.8 months , respectively , at median follow-up of 26.4 months .
RESULTS	Efficacy , tolerability , and quality-of-life results were similar between patients dosed in the AM or PM .
CONCLUSIONS	Sunitinib 37.5 mg , administered on a continuous once-daily dosing regimen , has a manageable safety profile as second-line mRCC therapy , providing flexible dosing , which can be explored in combination studies .

###24020364
BACKGROUND	Tumescent anaesthesia ( TA ) is a widely used technique in oncologic surgeries necessitating large resection margins .
BACKGROUND	This technique produces transoperative and postoperative analgesia , reduces surgical bleeding , and facilitates tissue divulsion .
BACKGROUND	This prospective , randomised , blind study evaluated the use of TA in bitches submitted to mastectomy and compared the effect of TA with an intravenous fentanyl bolus .
BACKGROUND	A 2.5-mcg / kg intravenous fentanyl bolus ( n = 10 ) was compared with TA using 0.275 % lidocaine ( n = 10 ) in bitches submitted to unilateral mastectomy .
BACKGROUND	Sedation was performed by intramuscular ( IM ) injection of 0.05 mg/kg of acepromazine combined with 2 mg/kg of meperidine .
BACKGROUND	Anaesthesia was induced with 5 mg/kg of intravenous propofol and maintained with isoflurane/O2 .
BACKGROUND	Heart and respiratory rates ; systolic , mean , and diastolic arterial blood pressures ; central venous pressure ; SpO2 ; ETCO2 ; inspired and expired isoflurane concentrations ; and temperature were measured transoperatively .
BACKGROUND	Visual analogue scales for sedation and pain and the Glasgow composite and Melbourne pain scales were used for postoperative assessment .
BACKGROUND	The surgeon investigated the quality of the surgical approach , considering bleeding and resection ability , and the incidence of postoperative wound complications .
RESULTS	The heart rate was lower and the end-tidal isoflurane concentration was higher in dogs treated with fentanyl than in dogs treated with TA .
RESULTS	A fentanyl bolus was administered to 8 of 10 dogs treated with fentanyl and to none treated with TA .
RESULTS	Intraoperative bleeding and the mammary gland excision time were lower in dogs treated with TA .
RESULTS	The maximal mean and individual plasma lidocaine concentrations were 1426 502 ng/ml and 2443 ng/ml at 90 minutes after infiltration , respectively .
RESULTS	The Glasgow Composite Pain Scale scores were higher in dogs treated with fentanyl than in dogs treated with TA until 2 hours after extubation .
CONCLUSIONS	Compared with intravenous fentanyl , TA in bitches : may be easily performed in non-inflamed , ulcerated , adhered mammary tumours ; has an isoflurane-sparing effect ; improves transoperative and immediate postoperative analgesia ; is apparently safe for use in clinical conditions as evidenced by the fact that it did not produce any adverse signs or lidocaine plasma concentrations compatible with toxicity ; does not modify the recovery time ; and facilitates the surgical procedure without interfering with wound healing .

###11704778
BACKGROUND	Many Americans have heartburn or related symptoms monthly and > 20 % experience heartburn at least once per day .
BACKGROUND	Although many self-treat episodic heartburn with nonprescription antacids , newer treatments that decrease gastric volume and increase the pH of refluxed material are proving effective and popular in relieving heartburn .
OBJECTIVE	To evaluate the safety and efficacy of low-dose regimens of ranitidine for the relief of heartburn .
METHODS	Adults with at least a 3-month history of heartburn were eligible for this randomized , double-blind , parallel group , multicenter dose-ranging study .
METHODS	Following a 1-week , open-label run-in phase to document baseline heartburn frequency , subjects were randomly assigned to receive treatment with one tablet of either ranitidine , 75 mg ( n = 537 ) ; ranitidine , 25 mg ( n = 539 ) ; or placebo ( n = 544 ) , to be taken as needed up to four times daily for 2 weeks for the relief of heartburn .
RESULTS	The ranitidine 75-mg regimen was statistically ( P < 0.05 ) and clinically ( as defined a priori as > or = 10 % improvement ) more effective than placebo in relieving episodic heartburn and in reducing antacid consumption .
RESULTS	Ranitidine , 25 mg , was also statistically superior ( P < 0.05 ) to placebo in providing heartburn relief .
RESULTS	In addition , both regimens were superior to placebo in providing heartburn relief within 30 to 45 minutes of dosing .
RESULTS	Ranitidine continued to be as effective over placebo in the treatment of the last heartburn episode as in the treatment of the first heartburn episode .
RESULTS	Ranitidine was also equally effective over placebo in the treatment of mild , moderate , and severe episodes of heartburn .
RESULTS	Ranitidine , 75 mg , was statistically superior to placebo for the relief of nocturnal heartburn episodes , whereas ranitidine , 25 mg , was not .
RESULTS	All treatments were well tolerated and adverse events occurred no more frequently with the ranitidine regimens than with placebo .
CONCLUSIONS	Low-dose ranitidine provides prompt and lasting relief of heartburn and has a safety profile comparable to that of placebo .

###12795776
OBJECTIVE	To determine the relative beta1-selectivity of three beta-blockers ( nebivolol , bisoprolol and atenolol ) , administered orally at normal therapeutic doses , by assessing their impact on the beta2-mediated , haemodynamic and biochemical responses to a terbutaline infusion , which decreases serum potassium and increases serum glucose and insulin .
METHODS	Twenty-four healthy volunteers ( 14 men , 10 women ) , with no history of respiratory disease , attended on five separate occasions ; beta-blockers ( nebivolol 5 mg , bisoprolol 10 mg , atenolol 50 and 100 mg ) or placebo were supplied in random order .
METHODS	Three baseline blood samples were collected at 65-85 min post-beta-blocker .
METHODS	A 60-min terbutaline infusion was started 90 min after taking the beta-blocker .
METHODS	Blood samples were taken and blood pressure and heart rate recorded at 15 min intervals up to 30-min post-infusion .
METHODS	Blood samples were analysed for serum potassium , glucose and insulin concentrations .
RESULTS	Terbutaline increased heart rate .
RESULTS	Pretreatment with nebivolol caused a modest and non-significant reduction in terbutaline-induced tachycardia whilst bisoprolol produced a more marked effect .
RESULTS	Atenolol at both 50 and 100 mg doses caused a highly significant reduction in terbutaline-induced tachycardia .
RESULTS	All active preparations had a comparable impact on the terbutaline-induced increase in systolic blood pressure , but the drugs had no impact on the changes produced in diastolic blood pressure .
RESULTS	After pretreatment with placebo , the terbutaline infusion caused a significant decrease in serum potassium and increases in serum glucose and insulin .
RESULTS	Pretreatment with nebivolol had no discernible effect on potassium compared with placebo .
RESULTS	In contrast , when compared with either placebo or nebivolol , bisoprolol ( P < 0.01 ) and both doses of atenolol ( P < 0.001 ) significantly attenuated the hypokalaemic effect of terbutaline .
RESULTS	Treatment with nebivolol and bisoprolol modestly but significantly reduced the terbutaline-induced increases in glucose ( P < 0.05 ) .
RESULTS	The blocking effects of both doses of atenolol were highly significant ( P < 0.001 ) when compared with placebo and also significant ( P < 0.05 and P < 0.01 , respectively ) when compared with nebivolol and bisoprolol .
RESULTS	A similar pattern of responses with the different beta-blocker treatments was observed for the effects on insulin concentrations during the terbutaline infusion .
CONCLUSIONS	The beta1-selectivity of three different beta1-blockers has been demonstrated in healthy volunteers using the blocking of biochemical and haemodynamic responses to a beta2 stimulus .
CONCLUSIONS	Terbutaline alone caused an increase in heart rate , a rise in systolic blood pressure , a fall in serum potassium and a rise in both serum glucose and insulin .
CONCLUSIONS	In this study , for both haemodynamic and biochemical responses , atenolol 100 mg had the greatest beta2-blocking effect , nebivolol 5 mg the least .
CONCLUSIONS	Bisoprolol 10 mg and atenolol 50 mg had intermediate effects ; bisoprolol was the more beta1-selective of these two .

###20493771
BACKGROUND	First-line chemotherapy for advanced non-small-cell lung cancer ( NSCLC ) is usually limited to four to six cycles .
BACKGROUND	Maintenance therapy can delay progression and prolong survival .
BACKGROUND	The oral epidermal growth factor receptor ( EGFR ) tyrosine-kinase inhibitor erlotinib has proven efficacy and tolerability in second-line NSCLC .
BACKGROUND	We designed the phase 3 , placebo-controlled Sequential Tarceva in Unresectable NSCLC ( SATURN ; BO18192 ) study to assess use of erlotinib as maintenance therapy in patients with non-progressive disease following first-line platinum-doublet chemotherapy .
METHODS	Between December , 2005 , and May , 2008 , 1949 patients were included in the run-in phase ( four cycles of platinum-based chemotherapy ) .
METHODS	At the end of the run-in phase , 889 patients who did not have progressive disease were entered into the main study , and were randomly allocated using a 1:1 adaptive randomisation method through a third-party interactive voice response system to receive erlotinib ( 150 mg/day ; n = 438 ) or placebo ( n = 451 ) until progression or unacceptable toxicity .
METHODS	Patients were stratified by EGFR immunohistochemistry status , stage , Eastern Cooperative Oncology Group performance status , chemotherapy regimen , smoking history , and region .
METHODS	Co-primary endpoints were progression-free survival ( PFS ) in all analysable patients irrespective of EGFR status , and PFS in patients whose tumours had EGFR protein overexpression , as determined by immunohistochemistry .
METHODS	This study is registered with www.ClinicalTrials.gov , number NCT00556712 .
RESULTS	884 patients were analysable for PFS ; 437 in the erlotinib group and 447 in the placebo group .
RESULTS	After a median follow-up of 11.4 months for the erlotinib group and 11.5 months for the placebo group , median PFS was significantly longer with erlotinib than with placebo : 12.3 weeks for patients in the erlotinib group versus 11.1 weeks for those in the placebo group ( HR 0.71 , 95 % CI 0.62-0 .82 ; p < 0.0001 ) .
RESULTS	PFS was also significantly longer in patients with EGFR-positive immunohistochemistry who were treated with erlotinib ( n = 307 ) compared with EGFR-positive patients given placebo ( n = 311 ; median PFS 12.3 weeks in the erlotinib group vs 11.1 weeks in the placebo group ; HR 0.69 , 0.58-0 .82 ; p < 0.0001 ) .
RESULTS	The most common grade 3 or higher adverse events were rash ( 37 [ 9 % ] of 443 patients in the erlotinib group vs none of 445 in the placebo group ) and diarrhoea ( seven [ 2 % ] of 443 patients vs none of 445 ) .
RESULTS	Serious adverse events were reported in 47 patients ( 11 % ) on erlotinib compared with 34 patients ( 8 % ) on placebo .
RESULTS	The most common serious adverse event was pneumonia ( seven cases [ 2 % ] with erlotinib and four [ < 1 % ] with placebo ) .
CONCLUSIONS	Maintenance therapy with erlotinib for patients with NSCLC is well tolerated and significantly prolongs PFS compared with placebo .
CONCLUSIONS	First-line maintenance with erlotinib could be considered in patients who do not progress after four cycles of chemotherapy .
BACKGROUND	F Hoffmann-La Roche Ltd. .

###22234381
BACKGROUND	It has previously been shown that impairment of postural stability is a side effect of typical antipsychotic drugs , which are largely administered to control psychosis and behavioral symptoms in elderly patients .
BACKGROUND	Surprisingly , no study has yet addressed this problem with second-generation antipsychotics .
OBJECTIVE	The objective of this study was to determine the extent to which risperidone at low doses altered balance control in healthy participants .
METHODS	Twelve healthy young adults received , following a randomized double-blind crossover design , a single oral dose of placebo , 1 and 3mg of risperidone on separate days at least 14days apart .
METHODS	Evaluation of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-abbreviated scoring form ( ESRS-A ) and measures of postural sway using a force platform were assessed over 9h following drug ingestion .
RESULTS	There is a significant increase in the postural stability item of the ESRS-A parkinsonism subscale at 3 and 6h following 3mg of risperidone only when compared to placebo .
RESULTS	With regard to balance control , body sway measures were increased at 1mg of risperidone but more pronounced at 3mg .
RESULTS	The peak effects were observed at 3h after administration of the drug and had not completely returned to baseline after 9h .
CONCLUSIONS	Risperidone administered at low doses did not elicit clinically detectable EPS but had significant effects on balance control .
CONCLUSIONS	A dose-response effect on impairment of balance was observed that followed the expected time course of the drug pharmacokinetics .
CONCLUSIONS	These results are likely to apply to older or demented individuals who have pre-existing balance control deficit .

###10582983
OBJECTIVE	Citicoline ( cytidine-5 ' - diphosphocholine ; CDP-choline ) may reduce central nervous system ischemic injury by stabilizing cell membranes and reducing free radical generation .
OBJECTIVE	A previous dose-comparison trial in patients with acute stroke found that 500 mg of citicoline appeared to improve neurological outcome with minimal side effects .
METHODS	The current trial was a 33-center , randomized , double-blind , efficacy trial in 394 patients comparing placebo ( n = 127 ) with citicoline ( n = 267 ) ( 500 mg po daily ) for 6 weeks , with a 6-week posttreatment follow-up period .
METHODS	Patients with acute ( 24 hours ) ischemic strokes clinically assessed to be in the middle cerebral artery territory with National Institutes of Health Stroke Scale ( NIHSS ) > or = 5 were enrolled .
RESULTS	Mean time to treatment was 12 hours , and mean age was 71 for placebo and 70 for citicoline .
RESULTS	Although mean baseline NIHSS were similar for both groups , there was a higher percentage of placebo patients with NIHSS < 8 ( 34 % vs 22 % ; P < 0.01 ) .
RESULTS	The incidence and type of side effects were similar between the groups .
RESULTS	The planned primary analysis ( logistic regression : 5 categories Barthel ) failed the proportional odds assumption and was rendered unreliable .
RESULTS	There were no between-group differences seen on the planned secondary assessment analyses at 90 days , including the Barthel Index > or = 95 at 12 weeks ( last observation carried forward : placebo 40 % ; citicoline 40 % ) or mortality rate ( placebo 18 % ; citicoline 17 % ) .
RESULTS	However , post hoc analyses in a subgroup of patients with baseline NIHSS > or = 8 found that citicoline-treated patients were more likely to have a full recovery ( Barthel > or = 95 ) : placebo 21 % ; citicoline 33 % ; P = 0.05 ; whereas no difference was seen in patients with baseline NIHSS < 8 ( placebo 77 % ; citicoline 69 % ; P > 0.1 .
CONCLUSIONS	The results of this study indicate that citicoline was safe but ineffective in improving the outcome of patients with acute ischemic stroke who were enrolled in this trial .
CONCLUSIONS	Post hoc analyses indicate that there may be a subgroup of patients with moderate to severe strokes who would benefit .

###22677568
OBJECTIVE	To compare the effectiveness of a mixture of acacia fiber , psyllium fiber , and fructose ( AFPFF ) with polyethylene glycol 3350 combined with electrolytes ( PEG+E ) in the treatment of children with chronic functional constipation ( CFC ) ; and to evaluate the safety and effectiveness of AFPFF in the treatment of children with CFC .
METHODS	This was a randomized , open label , prospective , controlled , parallel-group study involving 100 children ( M/F : 38/62 ; mean age SD : 6.5 2.7 years ) who were diagnosed with CFC according to the Rome III Criteria .
METHODS	Children were randomly divided into 2 groups : 50 children received AFPFF ( 16.8 g daily ) and 50 children received PEG+E ( 0.5 g/kg daily ) for 8 weeks .
METHODS	Primary outcome measures were frequency of bowel movements , stool consistency , fecal incontinence , and improvement of other associated gastrointestinal symptoms .
METHODS	Safety was assessed with evaluation of clinical adverse effects and growth measurements .
RESULTS	Compliance rates were 72 % for AFPFF and 96 % for PEG+E .
RESULTS	A significant improvement of constipation was seen in both groups .
RESULTS	After 8 weeks , 77.8 % of children treated with AFPFF and 83 % of children treated with PEG+E had improved ( P = .788 ) .
RESULTS	Neither PEG+E nor AFPFF caused any clinically significant side effects during the entire course of the study period .
CONCLUSIONS	In this randomized study , we did not find any significant difference between the efficacy of AFPFF and PEG+E in the treatment of children with CFC .
CONCLUSIONS	Both medications were proved to be safe for CFC treatment , but PEG+E was better accepted by children .

###22376026
OBJECTIVE	The aim was to evaluate whether oral swabbing with 0.2 % chlorhexidine gluconate ( CHX ) decreases the risk of ventilator-associated pneumonia ( VAP ) in intensive care unit ( ICU ) patients .
METHODS	Sixty-one dentate patients scheduled for invasive mechanical ventilation for at least 48 h were included in this randomized , double-blind , controlled study .
METHODS	As these patients were variably incapacitated , oral care was provided by swabbing the oral mucosa four times/d with CHX in the CHX group ( 29 patients ) and with saline in the control group ( 32 patients ) .
METHODS	Clinical periodontal measurements were recorded , and lower-respiratory-tract specimens were obtained for microbiological analysis on admission and when VAP was suspected .
METHODS	Pathogens were identified by quantifying colonies using standard culture techniques .
RESULTS	Ventilator-associated pneumonia developed in 34/61 patients ( 55.7 % ) within 6.8 d.
RESULTS	The VAP development rate was significantly higher in the control group than in the CHX group ( 68.8 % vs. 41.4 % , respectively ; p = 0.03 ) with an odds ratio of 3.12 ( 95 % confidence interval = 1.09-8 .91 ) .
RESULTS	Acinetobacter baumannii was the most common pathogen ( 64.7 % ) of all species identified .
RESULTS	There were no significant differences between the two groups in clinical periodontal measurements , VAP development time , pathogens detected or mortality rate .
CONCLUSIONS	The finding of the present study , that oral care with CHX swabbing reduces the risk of VAP development in mechanically ventilated patients , strongly supports its use in ICUs and indeed the importance of adequate oral hygiene in preventing medical complications .

###17616785
BACKGROUND	Some humans fed a low-choline diet develop hepatosteatosis , liver and muscle damage , and lymphocyte apoptosis .
BACKGROUND	The risk of developing such organ dysfunction is increased by the presence of single-nucleotide polymorphisms ( SNPs ) in genes involved in folate and choline metabolism .
OBJECTIVE	We investigated whether these changes that occur in the expression of many genes when humans are fed a low-choline diet differ between subjects who develop organ dysfunction and those who do not .
OBJECTIVE	We also investigated whether expression changes were dependent on the presence of the SNPs of interest .
METHODS	Thirty-three subjects aged 20-67 y were fed for 10 d a baseline diet containing the recommended adequate intake of choline .
METHODS	They then were fed a low-choline diet for up to 42 d or until they developed organ dysfunction .
METHODS	Blood was collected at the end of each phase , and peripheral lymphocytes were isolated and used for genotyping and for gene expression profiling with the use of microarray hybridization .
RESULTS	Feeding a low-choline diet changed the expression of 259 genes , and the profiles of subjects who developed and those who did not develop signs of organ dysfunction differed .
RESULTS	Group clustering and gene ontology analyses found that the diet-induced changes in gene expression profiles were significantly influenced by the SNPs of interest and that the gene expression phenotype of the variant gene carriers differed significantly even with the baseline diet .
CONCLUSIONS	These findings support our hypothesis that a person 's susceptibility to organ dysfunction when fed a low-choline diet is modulated by specific SNPs in genes involved in folate and choline metabolism .

###19909984
OBJECTIVE	Commonly used procedures to repair functional tricuspid regurgitation have a high failure rate .
OBJECTIVE	The present study was designed to lower this failure rate by reducing leaflet tethering via pericardial patch augmentation when the preoperative probability of recurrence was high .
METHODS	Between 2001 and 2007 , 210 patients with severe functional tricuspid regurgitation underwent tricuspid valve repair at the Day General Hospital .
METHODS	With respect to the type of repair , the patients were randomly divided into 4 groups : ( 1 ) De Vega in 52 patients ; ( 2 ) ring annuloplasty in 53 patients ; ( 3 ) De Vega and , if indicated by the preoperative tethering index ( tethering distance > 8 mm or tethering area > 16 mm ( 2 ) ) , pericardial patch augmentation in 53 patients ; and ( 4 ) ring annuloplasty and , if indicated by the preoperative tethering index ( tethering distance > 8 mm or tethering area > 16 mm ( 2 ) ) , pericardial patch augmentation in 52 patients .
METHODS	The results of 1-month and 1-year postoperative tricuspid regurgitation were evaluated .
RESULTS	Fifteen patients in group 3 and 15 patients in group 4 met the criterion for the complementary procedure .
RESULTS	Postoperative tricuspid regurgitation was different between the groups ( P < .05 ) : 16.0 % and 28.0 % of patients in the De Vega group , 8.0 % and 14.0 % of patients in the ring annuloplasty group , 4.0 % and 10.0 % of patients in the De Vega + pericardial patch augmentation group , and 2.0 % and 8.0 % of patients in the ring annuloplasty + pericardial patch augmentation group had postoperative tricuspid regurgitation at 1-month and 1-year follow-up , respectively .
CONCLUSIONS	An assessment of preoperative tricuspid valve tethering to select patients suitable for augmentation contributes to a good surgical outcome in patients with severe functional tricuspid regurgitation .

###18727886
OBJECTIVE	Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma , and it has been suggested that allowing patients to choose their own inhalers would resolve this problem .
OBJECTIVE	The FSI-10 ( Feeling of Satisfaction with Inhaler ) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use , portability , and usability of devices for delivery of inhaled corticosteroids .
OBJECTIVE	The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids : Turbuhaler , Accuhaler , and Novolizer .
METHODS	We performed a multicenter , prospective , observational study in 112 stable asthmatic patients ( 64 women ; mean [ SD ] age , 37 [ 22 ] years ) treated on a regular basis with inhaled corticosteroids .
METHODS	The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned .
METHODS	The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used .
METHODS	Once the protocol was completed , patients stated their preference for the different devices used .
RESULTS	The FSI-10 was easily understood and rapidly completed , and it exhibited acceptable measurement properties .
RESULTS	Factor analysis showed that the measure was unidimensional .
RESULTS	Although acceptance of all 3 devices assessed was reasonable , the FSI-10 questionnaire detected significant differences between them : Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions .
RESULTS	This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study .
RESULTS	However , the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer , even though the Turbuhaler had also usually been used by those patients prior to the study .
CONCLUSIONS	The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices .
CONCLUSIONS	It is easy to understand and complete , and able to identify differences in patient satisfaction with the different inhalers .

###23181618
BACKGROUND	Shivering during regional anesthesia is a common complication and is related to a decrease in the patient 's core body temperature .
BACKGROUND	Previous studies have shown that acupuncture on specific acupoints can preserve core body temperature .
BACKGROUND	The present study evaluated the effect of electroacupuncture in preventing the shivering caused by regional anesthesia .
METHODS	This prospective and randomized controlled study analyzed the data from 80 patients undergoing urological surgery , who were classified as ASA I or II .
METHODS	Spinal anesthesia was performed in all patients using 15mg of bupivacaine .
METHODS	The patients were randomly allocated to receive either placebo acupuncture ( Group P , n = 40 ) or electroacupuncture ( Group A , n = 40 ) for 30min before administration of spinal anesthesia .
METHODS	Shivering score was recorded at 5min intervals , with 0 representing no shivering and 4 representing the most severe shivering possible .
METHODS	Heart rate , blood pressure , and tympanic temperature were recorded before the intrathecal injection , and again every 5min thereafter until 30min .
RESULTS	After spinal anesthesia , the decrease in tympanic temperature was less for Group A patients than Group P , with the difference being statistically significant .
RESULTS	After 15min , 13 patients in Group P attained a shivering score of 3 or more , compared with 3 patients in Group A. Significantly more patients in Group P attained a shivering score of at least 1 .
CONCLUSIONS	The prophylactic use of electroacupuncture might maintain core body temperature , and may effectively prevent the shivering that commonly develops during regional anesthesia .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000096853 .

###23328268
BACKGROUND	Clopidogrel bisulfate , a potent antiplatelet agent , has a pivotal role in the prevention and treatment of atherothrombotic disease .
BACKGROUND	Clopidogrel napadisilate , a different salt preparation of clopidogrel , has been developed and approved in Korea and several European countries .
BACKGROUND	Recent studies have suggested that clopidogrel napadisilate might have improved stability and comparable bioequivalence to clopidogrel bisulfate .
BACKGROUND	However , these 2 clopidogrel preparations have not been compared in terms of efficacy and tolerability in patients with coronary artery disease ( CAD ) who underwent percutaneous coronary intervention ( PCI ) .
OBJECTIVE	We sought to investigate the antiplatelet efficacy and safety profile of clopidogrel napadisilate compared with clopidogrel bisulfate in CAD patients after PCI .
METHODS	This was a randomized , multicenter , open-label , Phase IV , noninferiority clinical trial .
METHODS	We prospectively recruited CAD patient in 6 institutions in Korea between October 2010 and November 2011 .
METHODS	Patients who underwent PCI were randomly assigned to the test group ( clopidogrel napadisilate plus aspirin ) or control group ( clopidogrel bisulfate plus aspirin ) .
METHODS	Antiplatelet efficacy and safety profile were assessed after 4 weeks of maintenance treatment .
METHODS	The primary end point was noninferiority of the percentage of P2Y ( 12 ) inhibition , measured by point-of-care assay .
METHODS	The rate of major adverse cardiovascular events ( MACE ) , as a secondary end point , was compared between the 2 clopidogrel preparations .
METHODS	To assess tolerability , we evaluated the incidence , severity , and causal relation of adverse events ( AEs ) of 2 groups .
RESULTS	A total of 169 patients were screened , and 127 patients completed the study ( 64 in the test group and 63 in the control group ; P = 0.296 ) .
RESULTS	The baseline characteristics of patients did not differ significantly between the treatment groups .
RESULTS	The between-group difference in percentage of P2Y ( 12 ) inhibition did not exceed the prespecified limit for noninferiority ( P for noninferiority = 0.032 ; 95 % CI , -8.33 to 5.53 ) .
RESULTS	With respect to the risk of MACE , no significant difference was found in the incidence of myocardial infarction or stroke between the groups ( 1 in the test group and 2 in the control group ; P > 0.99 ) ; no mortality was reported in either group .
RESULTS	The tolerability of clopidogrel napadisilate was comparable with that of clopidogrel bisulfate in terms of all AEs , drug-related AEs , and serious AEs ( all AEs : test group , 33.3 % ; control group , 32.9 % [ P > 0.99 ] ; drug-related AEs : test group , 4.17 % ; control group , 0 % [ P = 0.113 ] ; serious AEs : test group , 1.39 % ; control group , 5.26 % [ P = 0.367 ] ) .
CONCLUSIONS	In this study of CAD Korean patients who have undergone PCI , the antiplatelet efficacy of clopidogrel napadisilate was noninferior to that of clopidogrel bisulfate after 4 weeks of maintenance treatment .
CONCLUSIONS	No statistically significant difference was found in tolerability between the 2 treatment groups .

###23266342
BACKGROUND	New vaccines to prevent tuberculosis are urgently needed .
BACKGROUND	MVA85A is a novel viral vector TB vaccine candidate designed to boost BCG-induced immunity when delivered intradermally .
BACKGROUND	To date , intramuscular delivery has not been evaluated .
BACKGROUND	Skin and muscle have distinct anatomical and immunological properties which could impact upon vaccine-mediated cellular immunity .
METHODS	We conducted a randomised phase I trial comparing the safety and immunogenicity of 110 ( 8 ) pfu MVA85A delivered intramuscularly or intradermally to 24 healthy BCG-vaccinated adults .
RESULTS	Intramuscular and intradermal MVA85A were well tolerated .
RESULTS	Intradermally-vaccinated subjects experienced significantly more local adverse events than intramuscularly-vaccinated subjects , with no difference in systemic adverse events .
RESULTS	Both routes generated strong and sustained Ag85A-specific IFN T cell responses and induced multifunctional CD4 + T cells .
RESULTS	The frequencies of CD4 + T cells expressing chemokine receptors CCR4 , CCR6 , CCR7 and CXCR3 induced by vaccination was similar between routes .
CONCLUSIONS	In this phase I trial the intramuscular delivery of MVA85A was well tolerated and induced strong , durable cellular immune responses in healthy BCG vaccinated adults , comparable to intradermal delivery .
CONCLUSIONS	These findings are important for TB vaccine development and are of relevance to HIV , malaria , influenza and other intracellular pathogens for which T cell-inducing MVA-based vaccine platforms are being evaluated .

###15800692
BACKGROUND	Despite availability of numerous surgical and non-surgical options for the treatment of hemorrhoids like sclerotherapy , rubber band ligation , cryosurgery , infrared photocoagulation , bipolar diathermy , and electro coagulation , none of these therapies has been acclaimed as the ultimate .
BACKGROUND	Coagulation of hemorrhoids using a radio-frequency device is a new therapy to be added to the list .
METHODS	In the present retrospective study , the early and long - term effects of radiofrequency coagulation on patients presenting with hemorrhoids is described .
METHODS	An Ellman radiofrequency generator was used for this procedure .
METHODS	In a separate , randomized , and blinded study , a comparative evaluation was carried out between radiofrequency coagulation and rubber band ligation in terms of their effectiveness and patient comfort .
RESULTS	Two hundred and forty patients with Grade I and II hemorrhoids were treated by radiofrequency coagulation technique and were followed up for a period of 16 months .
RESULTS	While 33 patients reported persistence or recurrence of bleeding , only few complained of pain or discomfort .
RESULTS	The comparative study showed that though rubber band ligation is an effective procedure , its pain quotient is greater than the radiofrequency coagulation .
CONCLUSIONS	This study shows that radiofrequency coagulation is an easy and effective alternative to conventional techniques employed in the treatment of bleeding hemorrhoids .
CONCLUSIONS	It is easy to perform , is less painful , and has a low rate of complications .
CONCLUSIONS	However , further results based on a longer follow-up of larger number of patients and its comparison with other conventional treatment techniques are called for .

###24411976
OBJECTIVE	The purpose of this study was to determine whether 400 g/kg oral ivermectin is able to kill Ixodes scapularis nymphs and adult female ticks feeding on humans .
METHODS	Ten study subjects each wore 2 ostomy bags , the one containing 24 I scapularis nymphs , and the other containing 24 I scapularis adult females .
METHODS	Twenty-four hours after the ostomy bags were attached , study subjects received either 400 g/kg ivermectin or placebo .
METHODS	Thirty hours after the ivermectin or placebo was consumed , the ticks were removed , and mortality determined in a double-blinded manner .
RESULTS	Eleven percent of the I scapularis nymphs attached in the ivermectin group compared with 17 % in the placebo .
RESULTS	Mortality for the I scapularis nymphs that attached at the time of removal was 55 % in the ivermectin group and 47 % in the placebo group .
RESULTS	Mortality for the I scapularis nymphs 5 days after removal was 92 % in the ivermectin group and 88 % for the placebo .
RESULTS	Three percent of the I scapularis adults attached in the ivermectin group compared with 9 % in the placebo group .
RESULTS	Mortality for I scapularis adults was 0 % on day 3 and 33 % on day 8 for both the ivermectin and placebo groups .
RESULTS	There were statistically insignificant differences in the mortality rates between I scapularis nymphs and adults exposed to ivermectin or placebo .
CONCLUSIONS	There were a high number of ticks that died in both groups but the data do not support our hypothesis that ivermectin can kill I scapularis .
CONCLUSIONS	The study was not designed to determine whether it could prevent the transmission of tick-borne illness .

###23558840
BACKGROUND	The pattern and magnitude of the hyperglycemic response to surgical stress , the added effect of low-dose steroids , and whether these differ in diabetics and nondiabetics remain unclear .
BACKGROUND	We therefore tested 2 hypotheses : ( 1 ) that diabetics show a greater increase from preoperative to intraoperative glucose concentrations than nondiabetics ; and ( 2 ) that steroid administration increases intraoperative hyperglycemia more so in diabetics compared with nondiabetics .
METHODS	Patients scheduled for major noncardiac surgery under general anesthesia were enrolled and randomized to preoperative IV 8 mg dexamethasone or placebo , stratified by diagnosis of diabetes .
METHODS	Patients were part of a larger underlying trial ( the Dexamethasone , Light Anesthesia and Tight Glucose Control [ DeLiT ] Trial ) .
METHODS	IV insulin was given when glucose concentration exceeded 215 mg/dL .
METHODS	The primary outcome measure was the change in glucose from the preoperative to maximal intraoperative glucose concentration .
METHODS	We also report the time-dependent pattern of intraoperative hyperglycemia .
RESULTS	Ninety patients ( 23 % with diabetes ) were randomized to dexamethasone , and 95 ( 29 % with diabetes ) were given placebo .
RESULTS	The mean SD change from preoperative to maximal intraoperative glucose concentration was 63 69 mg/dL in diabetics and 72 45 mg/dL in nondiabetics .
RESULTS	The mean covariable-adjusted change ( 95 % confidence interval ) in nondiabetics was 29 ( 13 , 46 ) mg/dL more than in diabetics ( P < 0.001 ) .
RESULTS	For all patients combined , mean glucose increased slightly from preoperative to incision , substantially from incision to surgery midpoint , and then remained high and fairly stable through emergence , with nondiabetic patients showing a greater increase ( P < 0.001 ) .
RESULTS	For nondiabetics , the mean increase in glucose concentration ( 97.5 % CI ) was 29 ( 9 , 49 ) mg/dL more in patients given dexamethasone than placebo ( P = 0.0012 ) .
RESULTS	However , there was no dexamethasone effect in diabetics ( P = 0.99 ) .
CONCLUSIONS	Treatment of intraoperative hyperglycemia should account for the hyperglycemic surgical stress response trend depending on the stage of surgery as well as the added effects of steroid administration .
CONCLUSIONS	Denying steroid prophylaxis for postoperative nausea and vomiting for fear of hyperglycemic response should be reconsidered given the limited effect of steroids on intraoperative blood glucose concentrations .

###23835185
BACKGROUND	Although physiotherapists have long advocated workplace health , school teachers have not traditionally been a focus of study by these professionals .
BACKGROUND	However , classroom teaching contributes to a range of occupational health issues related to general health as well as ergonomics that can be prevented or addressed by physiotherapists .
OBJECTIVE	To undertake a pilot study to explore the potential effects of a physiotherapy-directed occupational health programme individualised for school teachers , develop study methodology and gather preliminary data to establish a ` proof of concept ' to inform future studies .
METHODS	Cluster randomised pilot study using a convenience sample .
METHODS	Eight Austrian regional secondary schools .
METHODS	Schools and their teachers were recruited and allocated to an intervention group ( IG , n = 26 teachers ) or a control group ( CG , n = 43 teachers ) .
METHODS	Teachers were eligible to participate if they reported no health issues that compromised their classroom responsibilities .
METHODS	The IG participated in an individualised physiotherapy-directed occupational health programme ( six 30-minute sessions ) related to ergonomics and stress management conducted over a 5-month semester .
METHODS	The CG had a pseudo-intervention of one oral education session .
METHODS	Primary outcomes included scores from the physical and mental components and health transition item of the Short-Form-36 Health Survey questionnaire ( SF-36 ) , and emotional well-being and resistance to stress items from the work-related behaviour and experience patterns questionnaire .
METHODS	Data were collected before and after one semester .
RESULTS	The primary outcome measure , the SF-36 physical component score , showed a reduction in the CG and no change in the IG , meaning that the CG deteriorated over the study semester while the IG did not show any change .
CONCLUSIONS	A physiotherapy-directed occupational health programme may prevent deterioration of physical health of school teachers in one semester ( proof of concept ) .
CONCLUSIONS	This pilot study provided valuable information to inform the design of replication and extension studies related to this work .

###20102995
BACKGROUND	Binge drinking is a common pattern of alcohol use in the US .
BACKGROUND	However , no studies have evaluated the effectiveness of brief interventions targeting only binge drinkers .
METHODS	Randomized controlled clinical trial with a 12-month follow-up period conducted from March 1 , 2003 to March 1 , 2006 in Spain .
METHODS	Of a screened population of 15,325 patients seeking routine medical care from their primary care providers , patients who met inclusion criteria were randomized into an experimental group ( n = 371 ) or a control group ( n = 381 ) .
METHODS	The primary outcome measures were the frequency of binge drinking episodes and weekly alcohol intake .
RESULTS	There were no significant differences at baseline between groups in alcohol use and demographic variables .
RESULTS	At the end of the 12-month follow-up period , there were significant reductions in binge-drinking status ( 52.2 % vs 67.2 % , P < .001 ) , number of episodes of binge drinking ( 1.14 vs 1.56 , P < .001 ) , number of drinks weekly ( 19.2 vs 22.4 , P < .001 ) , and frequency of excessive alcohol intake in 7 days ( 47.9 % vs 66.6 % , P > .001 ) .
CONCLUSIONS	This study provided evidence that screening and brief counseling delivered by a primary care physician as part of regular health care significantly reduced binge drinking episodes in binge drinkers .

###11355042
OBJECTIVE	To compare serum estrone sulfate ( E1S ) levels in postmenopausal women during long-term treatment with commonly prescribed doses of oral and transdermal estradiol ( E2 ) .
METHODS	A retrospective study performed in a University setting in the United States involving 33 healthy postmenopausal women .
METHODS	Two groups of postmenopausal women were studied : group 1 ( n = 10 ) received 1 mg oral micronized E2 daily for 16 months ; blood was drawn at 0 , 7 , and 15 months .
METHODS	Group 2 ( n = 23 ) was randomized into three subgroups .
METHODS	Two of the subgroups ( n = 8 ; n = 7 ) received E2 delivered at a rate of 0.05 mg/day and 0.1 mg/day , respectively , by transdermal patch , changed twice weekly ; the third subgroup received a placebo ( without E2 ) patch for 9 continuous months .
METHODS	Blood samples were drawn at 0 , 6 , and 9 months .
METHODS	Serum E1S and E2 were quantified by specific radioimmunoassays .
METHODS	Statistical analysis was performed by analysis of variance .
RESULTS	After oral E2 treatment , E1S levels increased significantly ( p < 0.01 ) from baseline , reaching an average level of 38.8 ng/mL at 15 months .
RESULTS	After transdermal E2 treatment , E1S levels increased significantly , yet to a much lesser extent , reaching levels of 1.8 ng/mL and 3.2 ng/mL after 9 months of treatment with the 0.05 mg/day and 0.1 mg/day patches , respectively .
CONCLUSIONS	Markedly elevated levels of E1S were found after long-term oral estrogen treatment .
CONCLUSIONS	In comparison to the increase in E1S levels after long-term oral estrogen treatment , there was only a small increase in E1S levels after transdermal E2 therapy .
CONCLUSIONS	This difference may be attributed to the higher dosage of oral E2 that is required because of the low bioavailability compared with the transdermal dosages .

###20800270
OBJECTIVE	To evaluate marginal integrity of direct resin composite restorations before and after thermo-mechanical loading in vitro , and before and after 6 years of clinical service in a prospective clinical trial .
METHODS	For the in vitro part , MO cavities with the proximal box beneath the cemento-enamel junction were prepared in 32 extracted human third molars .
METHODS	The specimens were randomly assigned to four groups ( n = 8 ) and received bonded resin composite restorations ( two groups each Grandio bonded with Solobond M and Tetric Ceram bonded with Syntac ) .
METHODS	Specimens were subjected to three different aging protocols : 6-year water storage ( WS ) , thermo-mechanical loading ( TML ; 100,00050 N ; 2500 +5 / +55 C ) , and 6-year water storage plus thermo-mechanical loading ( WS+TML ) .
METHODS	Initially and after aging , marginal qualities in enamel and dentin were evaluated using replicas at 200 magnification ( SEM ) .
METHODS	For the in vivo part , 30 patients received 68 direct resin composite restorations of the same materials in a prospective clinical trial .
METHODS	Replicas of 11 selected subjects per group were assessed for marginal quality under a SEM at 200 .
RESULTS	in vitro , all initial results showed nearly 100 % gap-free margins .
RESULTS	For TML , percentages of gap-free margins dropped to 87-90 % in enamel and to 58-66 % in dentin ( p < 0.05 ) .
RESULTS	For WS , enamel margins still were at 97-99 % whereas dentin margins exhibited 67-75 % gap-free margins , and for WS+TML , enamel margins were at 85-87 % and dentin margins at 42-52 % gap-free margins .
RESULTS	In vivo , gap-free enamel margins were reduced from initially 86-90 % to 74-80 % after 6 years of clinical service ( p < 0.05 ) .
RESULTS	Proximally exposed dentin margins were not recordable by impressions , however , clinically no considerable problems like recurrent caries or discolorations were detected .
CONCLUSIONS	In vitro , hydrolytic degradation supports mechanical fatigue in dentin-composite bonds over time .
CONCLUSIONS	In vivo , wear phenomena are superimposing marginal quality aspects .
CONCLUSIONS	Gaps between enamel and resin composite did not play a major role .

###12580994
OBJECTIVE	As statin therapy has been demonstrated to augment endothelial function in sedentary hypercholesterolaemia ( HC ) , we aimed to investigate the effects of atorvastatin therapy on endothelial function in physically active , HC men .
RESULTS	Eleven physically active , HC males were recruited .
RESULTS	Endothelial function [ forearm blood flow response to brachial artery infusion of acetylcholine ( Ach ) ] was assessed twice in each subject following atorvastatin or no therapy in a randomized crossover design .
RESULTS	In addition , endothelial function was compared with an active , normolipidaemic control group ( C ) .
RESULTS	Atorvastatin therapy reduced total and LDL cholesterol , but had no effect on basal blood flow or endothelial function ( peak ACh mean difference + / - standard error 0.75 + / - 1.75 ml min ( -1 ) per 100 ml tissue ) [ 95 % confidence interval ( CI ) -3.1 , 4.6 ] .
RESULTS	In addition , there was no difference in endothelial function between the HC and C groups ( -1.14 + / - 2.60 ml min ( -1 ) per 100 ml tissue ; CI -6.53 , 4.25 ) .
CONCLUSIONS	Statin therapy in HC patients with normal endothelial function does not augment endothelial function .

###17382220
BACKGROUND	Postoperative ileus ( POI ) , an interruption of coordinated bowel motility after operation , is exacerbated by opioids used to manage pain .
BACKGROUND	Alvimopan , a peripherally acting mu-opioid receptor antagonist , accelerated gastrointestinal ( GI ) recovery after bowel resection in randomized , double-blind , placebo-controlled , multicenter phase III POI trials .
BACKGROUND	The effect of alvimopan on POI-related morbidity for patients who underwent bowel resection was evaluated in a post-hoc analysis .
METHODS	Incidence of POI-related postoperative morbidity ( postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission ) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge ( 7 or fewer postoperative days ) .
METHODS	GI-related adverse events and opioid consumption were summarized for each treatment .
METHODS	Estimations of odds ratios of alvimopan to placebo and number needed to treat ( NNT ) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis .
RESULTS	Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo ( odds ratio = 0.44 , p < 0.001 ) .
RESULTS	Fewer patients receiving alvimopan ( alvimopan , 7.6 % ; placebo , 15.8 % ; NNT = 12 ) experienced POI-related morbidity .
RESULTS	There was a lower incidence of postoperative nasogastric tube insertion , and other GI-related adverse events on postoperative days 3 to 6 in the alvimopan group than the placebo group .
RESULTS	Opioid consumption was comparable between groups .
CONCLUSIONS	Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo , without compromising opioid-based analgesia in patients undergoing bowel resection .
CONCLUSIONS	Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system .

###24061719
OBJECTIVE	The aim of this study is to assess and compare the accuracy of two different patient-specific instrumentation ( PSI ) systems for total knee replacement , both intra-operatively for bone preparation and post-operatively for final component alignment .
METHODS	Twenty-five patients were treated according to a computer tomography ( CT ) - based PSI system ( group A ) and 25 to a magnetic resonance imaging ( MRI ) / X-ray-based system ( group B ) .
METHODS	Alignments on the three anatomical planes and resection thickness at the cutting blocks and at the resulting bone cuts were recorded intra-operatively by a standard surgical navigation system .
METHODS	Alignments of the prosthetic components and mechanical axis were also measured post-operatively on radiographs .
METHODS	These measurements at both the femur and tibia were compared with those of the corresponding pre-operative planning , considering discrepancies larger than 3 as outliers .
RESULTS	In both groups , the mean absolute differences between pre-operatively planned alignments and corresponding intra - and post-operative measurements ranged from a minimum of 1.2 to a maximum of 2.9 in all three anatomical planes .
RESULTS	In both groups and in both femur and tibia , the plane with the smallest percentage of outliers was the coronal , maximum 17 % .
RESULTS	The comparison between two groups was statistically significant ( p = 0.02 ) in the femoral sagittal plane , where group B showed smaller alignment discrepancies at the cutting blocks .
CONCLUSIONS	Both PSI systems showed good alignments in the coronal plane in all stages .
CONCLUSIONS	For a few measurements , a better performance was observed in the MRI/X-ray-based system than in the CT-based system .
METHODS	I.

###16574034
OBJECTIVE	Establishing local tolerability of transdermal opioid systems is important as more systems become available for use in a range of indications .
OBJECTIVE	We compared the skin irritation potential of a single application of transdermal fentanyl ( Durogesic D-trans ; DDTDF ) and transdermal buprenorphine ( Transtec ; TDB ) patches in healthy volunteers .
METHODS	46 healthy males and females ( mean age [ range ] : 59.6 [ 50-69 ] years ) with healthy skin received a single dose of both the DDTDF 25 mug/h patch and the TDB 35 mug/h patch in a randomised order under naltrexone cover .
METHODS	The incidence and severity of erythema was assessed at various timepoints after patch removal .
RESULTS	There was a non-significant trend towards a higher incidence of erythema 60 min after patch removal with TDB compared with DDTDF .
RESULTS	The severity of erythema at 60 min and the incidence of erythema at 72 h after patch removal were significantly higher with TDB than with DDTDF ( p = 0.01 and 22 % versus 4.9 % , p = 0.04 , respectively ) .
RESULTS	In general , the results from the chromametric assessment of treated skin were in agreement .
RESULTS	The incidence of topical adverse events ( AEs ) was lower with DDTDF than with TDB ( one versus six events ) and subjects preferred the DDTDF patch and felt it was less noticeable on the skin .
RESULTS	The DDTDF patch was considered less painful to remove , and , consistent with that , the TDB patch was judged to have better adhesion .
RESULTS	Twenty-one subjects reported systemic AEs with DDTDF plus naltrexone and 22 with TDB plus naltrexone , most of which were considered treatment-related , 34 and 60 AEs , respectively .
CONCLUSIONS	Local tolerability of transdermal opioid systems should be considered when making a therapeutic choice .
CONCLUSIONS	Even after a single application in healthy volunteers , differences in local tolerability , assessed both clinically and by chromametry , and patch comfort were shown between DDTDF and TDB , in favour of DDTDF .

###11811506
BACKGROUND	The aims of the present multi-center , randomized , controlled clinical trial were : 1 ) to compare the efficacy of the simplified papilla preservation flap with and without a barrier membrane in deep intrabony defects ; 2 ) to evaluate the postoperative morbidity and surgical complications ; and 3 ) to preliminarily test the impact of baseline tooth mobility on clinical outcomes .
METHODS	This parallel group , randomized , multi-center , controlled clinical trial involved 112 patients in 8 periodontal practices in 4 countries .
METHODS	A deep intrabony defect in each patient was accessed with the simplified papilla preservation flap .
METHODS	In the test defects , a bioabsorbable membrane was positioned .
METHODS	Patients ' experiences with the surgical procedure and postoperative period were evaluated with a questionnaire .
METHODS	Clinical outcomes included clinical attachment level ( CAL ) and probing depth ( PD ) changes .
RESULTS	Complete observations were available for 55 test and 54 control defects .
RESULTS	CAL gains at 1 year were 3.5 + / - 2.1 mm in the guided tissue regeneration ( GTR ) group and 2.6 + / - 1.8 mm in the control group ( P = 0.0117 ) .
RESULTS	CAL gains > or = 4 mm were observed in 50.9 % of GTR sites and 33.3 % of control sites .
RESULTS	A significant center effect of 2.1 mm was observed ( P = 0.01 ) .
RESULTS	Initial PD ( P = 0.01 ) and baseline tooth mobility ( P = 0.036 ) were significant covariates .
RESULTS	During the procedure , 30.4 % of test and 28.6 % of controls reported feeling moderate pain , and subjects estimated the hardship of the procedure at 24 + / - 25 visual analog scale ( VAS ) units in the test group , and at 22 + / - 23 VAS in controls .
RESULTS	In terms of the investigated outcomes , differences between test and control groups were not statistically significant .
RESULTS	Among the postoperative complications , edema was most prevalent at week 1 , and more frequently associated with the test treatment ( P = 0.01 ) .
RESULTS	In the test group , 53.6 % of membranes were exposed at week 3 .
CONCLUSIONS	The present study further supports the added benefits of guided tissue regeneration with respect to access flap alone in the treatment of deep intrabony defects , as well as the general efficacy of GTR in different clinical settings .
CONCLUSIONS	Furthermore , our study indicates a possible influence of baseline tooth mobility on clinical outcomes .

###17998497
BACKGROUND	Few reliable and efficient systems support the communication of test results to outpatients , and this may lead to patient dissatisfaction with test result communication .
BACKGROUND	The objective of this study was to assess the impact of physicians ' use of a test results management tool embedded in an electronic health record on patient satisfaction with test result communication .
METHODS	A prospective , cluster-randomized , controlled trial of 570 patient encounters in 26 outpatient primary care practices was performed from December 1 , 2002 , to April 31 , 2005 .
METHODS	Physicians in the intervention practices were trained and given access to a physician test results management tool with imbedded patient notification functions to evaluate whether patient satisfaction with communication of test results ordered by the primary care provider was improved .
METHODS	Patient satisfaction surveys were conducted by telephone after the patient underwent the test and were administered before and after the intervention in both arms .
RESULTS	The survey response rate after successful patient contact was 74.2 % ( 570/768 ) .
RESULTS	After adjusting for patient age , sex , race , socioeconomic status , and insurance type , the intervention significantly increased patient satisfaction with test results communication ( odds ratio , 2.35 ; 95 % confidence interval , 1.05-5 .25 ; P = .03 ) .
RESULTS	In addition , patients in the postintervention group were more satisfied with information given them for medical treatments and conditions regarding their results ( odds ratio , 3.45 ; 95 % confidence interval , 1.30-9 .17 ; P = .02 ) .
CONCLUSIONS	An automated test results management system can improve patient satisfaction with communication of test results ordered by their primary care provider and can improve patient satisfaction with the communication of information regarding their condition and treatment plans .

###25208357
OBJECTIVE	This randomized , single center , examiner-blind , controlled , parallel-group , 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil ( EO ) versus a 0.07 % cetylpyridinium chloride ( CPC ) - containing mouthrinse .
OBJECTIVE	A 5 % hydroalcohol solution was included as a control group .
METHODS	354 healthy volunteers ( 18-71 years of age ) were enrolled in this clinical trial ; 338 subjects completed the study .
METHODS	At baseline , 1 - , 3 - , and 6-month visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque assessments ( PI ) .
METHODS	Following randomization , subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds .
RESULTS	All rinses were well tolerated by the subjects , with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3 - and 6-month exams .
RESULTS	Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control .
RESULTS	At 6 months MGI and PI were reduced by 42.6 % and 42.0 % for EO and by 17.1 % and 13.9 % respectively , for CPC vs. control .
RESULTS	When compared to CPC , EO was statistically significantly superior at all post-baseline time-points .
RESULTS	EO showed increasing reductions in MGI of 10.5 % , 20.3 % and 30.7 % as well as reductions in PI of 12.7 % , 23.7 % and 32.6 % at 1 , 3 and 6 months , respectively .
RESULTS	When analyzing the number of healthy sites ( MGI scores of 0 or 1 ) , the beneficial effect of the EO-containing mouthrinse is 45.8 % greater than using a CPC-containing mouthrinse and 59.8 % greater than placebo .

###21967254
OBJECTIVE	This prospective study was designed to develop a steroid and calcineurin inhibitor-free regimen for kidney transplants using alemtuzumab .
METHODS	A single dose of alemtuzumab ( 30 mg ) was given preoperatively .
METHODS	Phase 1 : Twenty-one patients were randomized into 2 groups ; the tacrolimus ( n = 11 ) and the sirolimus groups ( n = 10 ) .
METHODS	Steroids were given for 5 days .
METHODS	Azathioprine ( 1 mg/kg ) was added when white blood cells 4000 cells/cm ( 3 ) .
METHODS	Mean follow-up was 48 2.8 and 48.2 1.6 months for the tacrolimus and sirolimus groups .
METHODS	Phase 2 : Twenty patients were included and the study design was modified .
METHODS	Tacrolimus was given for 2 months , and was replaced by sirolimus thereafter .
METHODS	The mean follow-up was 28.3 2.1 months .
RESULTS	Phase 1 : Acute rejection episodes were encountered in 5 patients of the tacrolimus versus 2 cases in the sirolimus group ( P = .44 ) .
RESULTS	Antibody-mediated rejection was diagnosed in 2 recipients in each group .
RESULTS	Four patients were switched from sirolimus to tacrolimus owing to resistant rejection , significant proteinuria , persistent thrombocytopenia , lymphocele , and urinary leakage .
RESULTS	One patient was shifted from tacrolimus to sirolimus owing to Kaposi sarcoma .
RESULTS	Glomerular filtration rate was significantly higher in the sirolimus group .
RESULTS	Currently , 14 patients ( 8 tacrolimus , and 6 sirolimus ) are steroid-free .
RESULTS	One patient died from the tacrolimus group owing to fulminant hepatitis .
RESULTS	Two grafts were lost in the sirolimus group versus 1 graft in the tacrolimus group .
RESULTS	Phase 2 : Five patients developed successfully treated borderline changes with no antibody-mediated rejection .
RESULTS	Mean serum creatinine was 114.9 17.7 mol/L .
RESULTS	Currently , 17 patients are steroid free and 15 of them are calcineurin inhibitor-free as well .
RESULTS	In this phase , only 1 patient died with a functioning graft .
CONCLUSIONS	This clinical trial provides a good insight into a potentially effective steroid and calcineurin inhibitor-free protocol with the use of alemtuzumab induction in combination with sirolimus .

###11684981
BACKGROUND	Anesthetic agents alter pharyngeal function with risk of impaired airway protection and aspiration .
BACKGROUND	This study was performed to evaluate pharyngeal function during subhypnotic concentrations of propofol , isoflurane , and sevoflurane and to compare the drugs for possible differences in this respect .
METHODS	Forty-five healthy volunteers were randomized to receive propofol , isoflurane , or sevoflurane .
METHODS	During series of liquid contrast bolus swallowing , fluoroscopy and simultaneous solid state videomanometry was used to study the incidence of pharyngeal dysfunction , the initiation of swallowing , and the bolus transit time .
METHODS	Pressure changes were recorded at the back of the tongue , the pharyngeal constrictor muscles , and the upper esophageal sphincter .
METHODS	After control recordings , the anesthetic was delivered , and measurements were made at 0.50 and 0.25 predicted blood propotol concentration ( Cp50 ( asleep ) ) for propofol and 0.50 and 0.25 minimum alveolar concentration ( MAC ) ( awake ) for the inhalational agents .
METHODS	Final recordings were made 20 min after the end of anesthetic delivery .
RESULTS	All anesthetics caused an increased incidence of pharyngeal dysfunction with laryngeal bolus penetration .
RESULTS	Propofol increased the incidence from 8 to 58 % , isoflurane from 4 to 36 % , and sevoflurane from 6 to 35 % .
RESULTS	Propofol in 0.50 and 0.25 Cp50 ( asleep ) had the most extensive effect on the pharyngeal contraction patterns ( P < 0.05 ) .
RESULTS	The upper esophageal sphincter resting tone was markedly reduced from 83 + / - 36 to 39 + / - 19 mmHg by propofol ( P < 0.001 ) , which differed from isoflurane ( P = 0.03 ) .
RESULTS	Sevoflurane also reduced the upper esophageal sphincter resting tone from 65 + / - 16 to 45 + / - 18 mmHg at 0.50 MAC ( awake ) ( P = 0.008 ) .
RESULTS	All agents caused a reduced upper esophageal sphincter peak contraction amplitude ( P < 0.05 ) , and the reduction was greatest in the propofol group ( P = 0.002 ) .
CONCLUSIONS	Subhypnotic concentrations of propofol , isoflurane , and sevoflurane cause an increased incidence of pharyngeal dysfunction with penetration of bolus to the larynx .
CONCLUSIONS	The effect on the pharyngeal contraction pattern was most pronounced in the propofol group , with markedly reduced contraction forces .

###24801219
OBJECTIVE	To investigate effects and functional mechanism of compound Congrongyizhi Capsule ( CCRC ) , a Chinese medicine , on cognitive functions against amnestic mild cognitive impairment ( aMCI ) patients with functional magnetic resonance imaging ( fMRI ) based on n-back task .
METHODS	Forty-one aMCI participants from hospital and local communities in Beijing and randomly divided into treatment ( 16 patients with CCRC capsule treatment ) , placebo ( 12 patients with placebo capsules ) and control group ( 13 patients with no treatment ) .
METHODS	The duration of intervention lasted for 3 months .
METHODS	Neuropsychological tests and fMRI were applied to assess cognitive ability and brain activation changes after three months treatment .
RESULTS	Drug group ( n = 16 ) presented increased significance in the MMSE ( P = 0.008 ) and digit span ( P < 0.001 ) tests , while other scores of neuropsychological tests showed no statistical significance .
RESULTS	fMRI results showed an increased brain negative activation in drug group during performing the n-back working-memory task in posterior cingulate ( PCC ) , inferior frontal gyrus and lingual gyrus regions after 3 months ; placebo and control group did not show the same effect .
RESULTS	Meanwhile , there were negative correlations between left PCC activation levels and changed values of MMSE and digit span separately since increased negative activation was associated with better performance on the scores of MMSE and Digit Span tests .
CONCLUSIONS	CCRC can increase negative activation degree of PCC under performing working memory tasks while this modulation are associated with better performance on the MMSE and Digit Span .

###24925026
BACKGROUND	In adults with Williams-Beuren syndrome ( WBS ) , a common endocrine abnormality is type 2 diabetes mellitus ( T2DM ) or impaired glucose tolerance ( IGT ) .
BACKGROUND	However , few and sporadic data are available in children , adolescents , and young adults with WBS .
OBJECTIVE	To evaluate the frequency of IGT and T2DM in a cohort of children and young patients with WBS .
METHODS	We longitudinally evaluated 27 patients ( 9 males and 18 females , median age at study onset 13.6 years ) with WBS .
METHODS	The median follow-up was 3.6 years .
METHODS	Variables of insulin resistance and - cell function were evaluated in all subjects using an oral glucose tolerance test .
METHODS	The homeostasis model assessment ( HOMA ) of insulin resistance and the Matsuda index of insulin sensitivity were calculated .
METHODS	The study of the GCK and HNF1 genes was performed in patients with glucose metabolism abnormalities .
METHODS	45 age - and sex-matched healthy subjects and 51 age - , sex - and BMI-matched subjects were recruited as two control groups .
RESULTS	Considering nutritional status , 7 ( 25.9 % ) patients were obese , 9 ( 33.3 % ) overweight , and 11 ( 40.8 % ) normal-weight .
RESULTS	One ( 3.1 % ) patient had acanthosis nigricans .
RESULTS	IGT was diagnosed in 7 ( 25.9 % ) WBS patients and T2DM in 3 ( 11.1 % ) .
RESULTS	Considering all WBS patients , the median value of HOMA was 5.23 ( range 2.93-14 .89 ; insulin 24.73 14.67 U/ml ; glucose 104.98 16.06 mg/dl ) .
RESULTS	Considering BMI values , HOMA was 11.00 ( range 6.53-12 .56 ) , 5.64 ( range 3.54-7 .95 ) , and 4.54 ( range 3.21-5 .43 ) , and insulin was 34.53 6.84 , 22.76 8.91 , and 19.47 6.01 U/ml in obese , overweight , and normal-weight WBS patients , respectively .
RESULTS	Comparing the results with the two control groups , WBS patients showed higher insulin values than healthy controls ( p < 0.001 ) , but similar values as the BMI-matched control group ( p = n.s. ) .
RESULTS	However , WBS patients showed significantly higher values of glycemia ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) and HOMA ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) than the two control groups .
RESULTS	Finally , among WBS patients there was a higher number of subjects with IGT and T2DM than among healthy controls ( p < 0.0001 ) and the BMI-matched control group ( p = 0.0002 ) .
CONCLUSIONS	Our data strongly suggest that IGT and T2DM may be frequently discovered in children , adolescents , and young adults with WBS .
CONCLUSIONS	WBS should be included among the genetic syndromes associated with T2DM .
CONCLUSIONS	Further studies are necessary to evaluate the etiopathogenesis of this aspect .

###12944569
BACKGROUND	We compared two strategies for treating patients infected with multidrug-resistant human immunodeficiency virus ( HIV ) .
METHODS	Patients with multidrug-resistant HIV and HIV RNA levels of more than 5000 copies per milliliter were randomly assigned to a four-month structured interruption of treatment followed by a change in antiretroviral regimen ( treatment-interruption group ) or to an immediate change in regimen ( control group ) .
METHODS	Genotypic and phenotypic resistance testing was performed .
METHODS	Disease progression , death , and changes in genotypic resistance , CD4 cell counts , HIV RNA levels , and quality of life were assessed .
RESULTS	After a median follow-up of 11.6 months , disease progression or death occurred in 22 of the 138 patients in the treatment-interruption group and in 12 of the 132 patients in the control group ( P = 0.01 ) , with a hazard ratio of 2.57 ( 95 percent confidence interval , 1.2 to 5.5 ) for the treatment-interruption group .
RESULTS	There were eight deaths in each group .
RESULTS	In the treatment-interruption group , the mutant HIV populations completely or partially reverted to wild type by four months in 64.0 percent of patients .
RESULTS	As compared with the control group , the treatment-interruption group had a mean CD4 cell count that was 85 cells per cubic millimeter lower from months 0 through 4 ( P < 0.001 ) , 47 cells per cubic millimeter lower from months 5 through 8 ( P < 0.001 ) , and 31 cells per cubic millimeter lower after eight months ( P = 0.11 ) .
RESULTS	The mean HIV RNA levels were 1.2 log copies per milliliter higher ( on a base-10 scale ) in the treatment-interruption group during months 0 through 4 ( P < 0.001 ) , but they were not significantly different from those in the control group after month 4 .
RESULTS	The overall quality of life was similar in the two groups .
CONCLUSIONS	In patients infected with multidrug-resistant HIV , structured interruption of treatment was associated with greater progression of disease and did not confer immunologic or virologic benefits or improve the overall quality of life .

###16814646
OBJECTIVE	This study was designed to determine the relationship between clopidogrel and early ST-segment resolution ( STRes ) and the interaction of the two with clinical outcomes after fibrinolysis .
BACKGROUND	ST-segment resolution is an early noninvasive marker of coronary reperfusion .
METHODS	The CLARITY-TIMI 28 ( Clopidogrel as Adjunctive Reperfusion Therapy-Thrombolysis in Myocardial Infarction 28 ) trial randomized 3,491 patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing fibrinolysis to clopidogrel versus placebo .
METHODS	ST-segment resolution was defined as complete ( > 70 % ) , partial ( 30 % to 70 % ) , or none ( < 30 % ) .
RESULTS	Electrocardiograms were valid for interpretation in 2,431 patients at 90 min and 2,087 at 180 min .
RESULTS	There was no difference in the rate of complete STRes between the clopidogrel and placebo groups at 90 min ( 38.4 % vs. 36.6 % at 90 min ) .
RESULTS	When patients were stratified by STRes category , treatment with clopidogrel resulted in greater benefit among those with evidence of early STRes , with greater odds of an open artery at late angiography in patients with partial ( odds ratio [ OR ] 1.4 , p = 0.04 ) or complete ( OR 2.0 , p < 0.001 ) STRes , but no improvement in those with no STRes at 90 min ( OR 0.89 , p = 0.48 ) ( p for interaction = 0.003 ) .
RESULTS	Clopidogrel was also associated with a significant reduction in the odds of an in-hospital death or myocardial infarction in patients who achieved partial ( OR 0.30 , p = 0.003 ) or complete STRes at 90 min ( OR 0.49 , p = 0.056 ) , whereas clinical benefit was not apparent in patients who had no STRes ( OR 0.98 , p = 0.95 ) ( p for interaction = 0.027 ) .
RESULTS	By 30 days , the clinical benefit of clopidogrel was predominately seen in patients with complete STRes .
CONCLUSIONS	Clopidogrel appears to improve late coronary patency and clinical outcomes by preventing reocclusion of open arteries rather than by facilitating early reperfusion .

###9298055
OBJECTIVE	To analyze the data for cultures and Gram stains prospectively collected by protocol in the Endophthalmitis Vitrectomy Study .
METHODS	Cultures of aqueous , undiluted vitreous , and ( for patients who underwent vitrectomy ) vitrectomy cassette fluid obtained from 420 patients were prepared on chocolate agar , in thioglycolate broth , and on Sabouraud dextrose agar ; Gram stains of the aqueous and undiluted vitreous were made .
METHODS	Criteria were devised to distinguish true pathogens ( confirmed positive cultures ) from contaminants .
METHODS	Private and university-based retina-vitreous practices and corresponding microbiology laboratories .
RESULTS	Compared with the aqueous , undiluted vitreous produced a higher percentage of confirmed positive cultures and higher colony counts on chocolate agar and was more frequently the only source of a positive culture from the eye .
RESULTS	Nevertheless , the aqueous and vitrectomy cassette fluid were the only source of a positive culture from the eye in 4.2 % and 8.9 % of eyes , respectively .
RESULTS	The overall yields of chocolate agar and thioglycolate broth were similar .
RESULTS	A positive Gram stain from the aqueous or undiluted vitreous was highly predictive of a positive culture from the eye , but a negative Gram stain had little predictive value for the culture result .
RESULTS	The overall rate of laboratory-confirmed infection was not statistically significantly higher in the vitrectomy group than in the tap or biopsy group .
CONCLUSIONS	The vitreous was a richer source of positive cultures and high colony counts than was the aqueous , either because it is more supportive of bacterial growth or because a somewhat larger inoculum of the vitreous than of aqueous could be obtained .
CONCLUSIONS	The result of Gram stain should not determine the choice of antibiotic drugs in the treatment of endophthalmitis .
CONCLUSIONS	Vitrectomy , with culture of the vitrectomy cassette fluid , did not produce significantly more positive cultures than tap or biopsy material , and the procedure should not be performed to improve the microbiological yield .

###19118695
OBJECTIVE	To compare contrast acuity at different illumination levels and color vision and the subjective impression in patients after bilateral cataract surgery with a mixed implantation of a blue-light-filtering and an ultraviolet ( UV ) - filtering intraocular lens ( IOL ) .
METHODS	Randomized , controlled , double-masked , and bilateral study with intraindividual comparison .
METHODS	This study included 48 eyes of 24 consecutive patients with age-related cataract .
METHODS	Each patient had standardized small incision cataract surgery with IOL implantation into the capsular bag .
METHODS	Patients were randomly assigned to receive a blue-light-filtering Hoya AF-1 ( UY ) YA-60BB IOL in one eye and a UV-filtering Hoya AF-1 ( UV ) VA-60BB IOL ( Hoya Medical Europe , Frankfurt/Main , Germany ) in the contralateral eye .
METHODS	Contrast acuity was measured at illumination levels of 500 , 5 , and 0.5 lux and contrast levels of 100 % , 50 % , 25 % , 12.5 % , and 6.25 % .
METHODS	Color vision was assessed using the Lanthony desaturated D-15 test , the Lanthony new color test ( Munsell chroma 2 and 4 ) , and an anomaloscope .
METHODS	Blue/yellow foveal threshold was tested applying short-wave automated perimetry .
METHODS	The subjective visual impression of patients was evaluated using a questionnaire .
METHODS	Contrast acuity , color vision , and foveal threshold .
RESULTS	The blue-light-filtering IOLs had worse contrast acuity ( P = 0.0004 ) and foveal threshold ( P = 0.008 ) compared with the UV-filtering IOLs .
RESULTS	Color vision tests and high-contrast visual acuity did not show any statistically significant differences between IOLs ( P > 0.05 ) .
RESULTS	On questioning , 3 of 24 patients noticed a difference between the implanted IOLs concerning visual impression .
CONCLUSIONS	This study shows that blue-light-filtering IOLs negatively affect contrast acuity and blue/yellow foveal threshold when compared with UV-filtering IOLs .
CONCLUSIONS	Although the differences were small , the results suggest bilateral implantation of the same IOL type and avoidance of a mixed implantation of a blue-light-filtering IOL in one and a non-blue-light-filtering IOL in the contralateral eye in patients with high demands in color vision .
BACKGROUND	The author ( s ) have no proprietary or commercial interest in any materials discussed in this article .

###25139479
BACKGROUND	Transvaginal cholecystectomy ( TVC ) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery ( NOTES ) .
BACKGROUND	Randomized , controlled trials to assess TVC as a surgical strategy are largely missing .
METHODS	The study was a double blind , randomized , controlled , single center trial in female patients > 18 years with symptomatic cholecystolithiasis comparing laparoscopic cholecystectomy ( CLC ) and TVC .
METHODS	The study investigated pain reduction of 1 point on a visual-numeric rating scale with a follow-up after 7 days .
METHODS	Secondary endpoints were complications and patient reported outcome .
METHODS	Groups were established using computer-generated randomization and sealed envelopes in the operating theatre .
METHODS	At the end of the surgical procedure all patients received a standard 4-trocar dressing as for CLC and a vaginal tamponade .
RESULTS	A total of 426 patients were asked to participate , of which 97 were randomized , 51 in the CLC , 41 in the TVC groups and 5 were excluded from the study .
RESULTS	Patients were comparable regarding age , body mass index ( BMI ) and American Society of Anesthesiologists ( ASA ) grade .
RESULTS	Surgical and anesthesia times were significantly different .
RESULTS	There was no difference in postoperative pain .
RESULTS	The majority of patients were satisfied with both procedures and TVC was recommended to other patients by 93 % of patients in the TVC group .
CONCLUSIONS	The results did not show superiority of TVC over CLC with regards to postoperative pain .
CONCLUSIONS	With no differences in postoperative pain and high patient satisfaction , TVC can be recommended to future patients as an alternative method .
CONCLUSIONS	For confirmation of this evaluation of TVC further randomized trials are needed .

###24747996
BACKGROUND	Many workers suffer from low-back pain .
BACKGROUND	Type and severity of spinal complaints have relationship with work load .
BACKGROUND	Lack of adherence to ergonomics recommendations among the important causes of low-back pain .
OBJECTIVE	To assess the effect of 3 ergonomics training programs on the prevalence of lowback pain among workers of an Iranian automobile factory .
METHODS	In a parallel-design 4-arm randomized clinical trial , 760 active workers of an automobile factory were studied .
METHODS	503 workers were found eligible and randomized into 3 intervention groups ( n = 252 ) , and a control group ( n = 251 ) .
METHODS	The intervention groups consisted of 3 arms : 84 workers were educated by pamphlet , 84 by lectures , and 84 by workshop .
METHODS	Nordic questionnaire was used to determine the prevalence of spinal complaint before and 1-year after the interventions .
METHODS	The trial is registered with the Iranian Randomized Clinical Trial Registry , number IRCT2013061213182N2 .
RESULTS	Out of 503 workers , 52 lost to follow-up leaving 451 workers for analyses .
RESULTS	The prevalence of low-back pain at the baseline was not significantly different among the studied arms .
RESULTS	1-year after the interventions , the prevalence did not change significantly from the baseline values for the lecture and pamphlet group .
RESULTS	However , the prevalence of LBP experienced during the last year significantly ( p = 0.036 ) decreased from 42 % to 23 % in participant took part in the workshop .
CONCLUSIONS	Training of automobile factory workers in ergonomics is more effective by running workshop than giving lecture or disseminating pamphlet .

###22986218
OBJECTIVE	To investigate the potential of information and communication technology ( ICT ) adoption among maternal and child health workers in rural Nigeria .
METHODS	A prospective , quantitative survey design was used to collect data from quasi-randomly selected clusters of 25 rural health facilities in 5 of the 36 states in Nigeria over a 2-month period from June to July 2010 .
METHODS	A total of 200 maternal and child health workers were included in the survey , and the data were analyzed using a modified theory of acceptance model ( TAM ) .
RESULTS	There was no significant difference between ICT knowledge and attitude scores across states .
RESULTS	There were significant differences in perceived ease of use ( P < .001 ) and perceived usefulness scores ( P = .001 ) across states .
RESULTS	Midwives reported higher scores on all the constructs but a lower score on endemic barriers ( which is a more positive outcome ) .
RESULTS	However , the differences were only statistically significant for perceived usefulness ( P = .05 ) and endemic barriers ( P < .001 ) .
RESULTS	Regression analysis revealed that there was no interaction between worker group and age .
RESULTS	Older workers were likely to have lower scores on knowledge and attitude but higher scores on perceived ease of use and perceived usefulness .
RESULTS	Lastly , we found that worker preference for ICT application in health varied across worker groups and conflicted with government/employer priorities .
CONCLUSIONS	Although the objective of this study was exploratory , the results provide insight into the intricacies involved in the deployment of ICT in low-resource settings .
CONCLUSIONS	Use of an expanded TAM should be considered as a mandatory part of any pre-implementation study of ICT among health workers in sub-Saharan Africa .

###12663287
BACKGROUND	Combined supplementation with iron and zinc during infancy may be effective in preventing deficiencies of these micronutrients , but knowledge of their potential interactions when given together is insufficient .
OBJECTIVE	The goal was to compare the effect in infants of combined supplementation with iron and zinc and of supplementation with single micronutrients on iron and zinc status .
METHODS	Indonesian infants ( n = 680 ) were randomly assigned to daily supplementation with 10 mg Fe ( Fe group ) , 10 mg Zn ( Zn group ) , 10 mg Fe + 10 mg Zn ( Fe + Zn group ) , or placebo from 6 to 12 mo of age .
METHODS	Venous blood samples were collected at the start and end of the study .
METHODS	Five hundred forty-nine infants completed the supplementation and had both baseline and follow-up blood samples available for analysis .
RESULTS	Baseline prevalences of anemia , iron deficiency anemia ( anemia and low serum ferritin ) , and low serum zinc ( < 10.7 micromol/L ) were 41 % , 8 % , and 78 % , respectively .
RESULTS	After supplementation , the Fe group had higher hemoglobin ( 119.4 compared with 115.3 g/L ; P < 0.05 ) and serum ferritin ( 46.5 compared with 32.3 microg/L ; P < 0.05 ) values than did the Fe + Zn group , indicating an effect of zinc on iron absorption .
RESULTS	The Zn group had higher serum zinc ( 11.58 compared with 9.06 micromol/L ; P < 0.05 ) than did the placebo group .
RESULTS	There was a dose effect on serum ferritin in the Fe and Fe + Zn groups , but at different levels .
RESULTS	There was a significant dose effect on serum zinc in the Zn group , whereas no dose effect was found in the Fe + Zn group beyond 7 mg Zn/d .
CONCLUSIONS	Supplementation with iron and zinc was less efficacious than were single supplements in improving iron and zinc status , with evidence of an interaction between iron and zinc when the combined supplement was given .

###10555719
OBJECTIVE	To investigate the effect on immunization levels of retrospective written feedback to residents regarding missed immunization opportunities .
METHODS	Randomized trial with control group .
METHODS	Pediatric resident continuity clinic in an urban hospital-based primary care clinic .
METHODS	Thirty-two postgraduate level 2 and postgraduate level 3 pediatric residents .
METHODS	Monthly retrospective written feedback mailed to residents detailing their missed immunization opportunities and appointment failure rates over a 12-month period beginning in February 1997 .
METHODS	The immunization level of 2-year-old children in the resident clinic was the main outcome of interest .
METHODS	Secondary outcomes included missed immunization opportunity rates and appointment failure rates .
RESULTS	Postintervention immunization levels were 71.4 % ( 95 % confidence limits [ CLs ] : 63.2 % , 78.7 % ) for patients from the intervention group and 68.5 % ( 95 % CLs : 60.8 % , 75.4 % ) for patients from the control group .
RESULTS	The immunization level for patients of both groups who had fewer than 2 visits during the second year of life was 47.2 % ( 95 % CLs : 38.2 % , 56.3 % ) .
RESULTS	This compares with an immunization level of 78.1 % ( 95 % CLs : 66.0 % , 87.5 % ) for patients from both groups who had 2 visits during the second year of life , and with an immunization level of 88.2 % ( 95 % CLs : 81.0 % , 93.4 % ) for patients of both groups who had more than 2 visits during the second year of life ( P < .001 ) .
CONCLUSIONS	In this setting , written retrospective feedback to residents was an ineffective strategy for improving immunization levels .
CONCLUSIONS	Adequate follow-up during the second year of life is critical in achieving high immunization levels .

###24571855
BACKGROUND	Chronic pain can disrupt the cortical representation of a painful body part .
BACKGROUND	This disruption may play a role in maintaining the individual 's pain .
BACKGROUND	Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions .
BACKGROUND	However , there is little evidence for the effectiveness of this intervention for chronic low back pain ( CLBP ) .
BACKGROUND	The primary aim of this study was to inform the development of a fully powered randomised controlled trial ( RCT ) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP .
BACKGROUND	The secondary aim was to obtain qualitative feedback about the intervention .
METHODS	In this mixed-methods pilot RCT 15 individuals were randomised to either an intervention ( tactile acuity training ) or a placebo group ( sham tactile acuity training ) .
METHODS	All participants received 3 sessions of acuity training ( intervention or sham ) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer ( friend/relative ) .
METHODS	All participants also received usual care physiotherapy .
METHODS	The primary outcome measures were pain ( 0-100visual analogue scale ( VAS ) ) and function ( Roland Morris Disability Questionnaire ( RMDQ ) ) .
METHODS	Participants and their informal carers were invited to a focus group to provide feedback on the intervention .
RESULTS	The placebo group improved by the greatest magnitude for both outcome measures , but there was no statistically significant difference ( Mean difference ( 95 % CI ) , p-value ) between groups for change in pain ( 25.6 ( -0.7 to 51.9 ) , p = 0.056 ) or function ( 2.2 ( -1.6 to 6.0 ) , p = 0.237 ) .
RESULTS	Comparing the number of individuals achieving a minimally clinically significant improvement , the placebo group had better outcomes for pain with all participants achieving 30 % improvement compared to only a third of the intervention group ( 6/6 vs. 3/9 , p = 0.036 ) .
RESULTS	Qualitatively , participants reported that needing an informal carer was a considerable barrier to the home training component of the study .
CONCLUSIONS	This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP .
CONCLUSIONS	That the intervention could not be self-applied was a considerable barrier to its use .
BACKGROUND	ISRCTN98118082 .

###21177084
OBJECTIVE	To evaluate the effect of bakumondoto , Kampo medicine , on cough in patients with chronic obstructive pulmonary disease ( COPD ) .
METHODS	A 16-week , randomized , open-labeled , cross-over design .
METHODS	Outpatient clinics at one university hospital and two general hospitals in Japan from May 2007 to March 2009 .
METHODS	Twenty-four elderly patients ( 14 men and 9 women aged over 65 ) with COPD .
METHODS	Treatment with or without bakumondoto for 8 weeks in a cross-over design .
METHODS	The primary outcome measurements were the frequency and intensity of cough assessed by a visual analogue scale ( VAS ) and a daily cough diary .
METHODS	Secondary outcome measurements were quality of life ( QOL ) assessed using St. George 's Respiratory Questionnaire ( SGRQ ) and lung functions measured using spirometry .
RESULTS	Treatment with bakumondoto significantly improved cough severity during the first treatment period ( week 0 vs. week 8 , p = 0.004 ) and showed a trend to decrease during the second treatment period ( week 8 vs. week 16 , p = 0.129 ) assessed by the VAS .
RESULTS	Neither QOL nor lung function was affected by the treatment with bakumondoto .
CONCLUSIONS	Bakumondoto may be effective in suppressing cough in elderly patients with COPD .
CONCLUSIONS	To further confirm the efficacy , a larger and placebo-controlled study with objective cough assessment is necessary .

###8618603
BACKGROUND	In the advanced stages of the acquired immunodeficiency syndrome ( AIDS ) , cytomegalovirus ( CMV ) disease , particularly vision-damaging retinitis due to CMV is common .
BACKGROUND	We evaluated prophylactic treatment with orally administered ganciclovir as a way to prevent CMV disease .
METHODS	We conducted a prospective , randomized , double-blind , placebo-controlled study of CMV infected persons with AIDS with either CD4 + lymphocyte counts of < or = 50 per cubic millimeter or counts of < or = 100 per cubic millimeter in those with a history of an AIDS defining opportunistic infection .
METHODS	Patients were randomly assigned , in a 2:1 ratio , to receive either oral ganciclovir ( 1000 mg three times daily ) or placebo .
RESULTS	The study was stopped after a median 367 days of follow-up .
RESULTS	In an intention-to-treat analysis , the twelve month cumulative rates of confirmed CMV disease were 26 percent in the placebo group ( n = 239 ) and 14 percent in the ganciclovir group ( n = 486 ) , representing an overall reduction in risk of 49 percent in the ganciclovir group ( P < 0.001 ) .
RESULTS	The incidence of CMV retinitis after 12 months was 24 percent in the placebo group and 12 percent in the ganciclovir group ( P < 0.0001 ) .
RESULTS	The prevalence of CMV-positive urine cultures at base line was 42 percent ; after two months it was 43 percent in the placebo group and 10 percent in the ganciclovir group ( P < 0.0001 ) .
RESULTS	The one year mortality rate was 26 percent in the placebo group and 21 percent in the ganciclovir group ( P = 0.14 ) .
RESULTS	Therapy with granulocyte colony stimulating factor was more frequent in the ganciclovir group ( 24 percent ) than in the placebo group ( 9 percent ) .
CONCLUSIONS	In persons with advanced AIDS , phophylactic oral ganciclovir significantly reduces the risk of CMV disease .

###24801567
BACKGROUND	To assess the effect of aging on stretch reflex modulation during walking , soleus H-reflexes obtained in 15 middle-aged ( mean age 56.46.9 years ) and 15 young ( mean age 23.73.9 years ) subjects were compared .
METHODS	The H-reflex amplitude , muscle activity ( EMG ) of the soleus and tibialis anterior muscles , and EMG/H-reflex gain were measured during 4-km/h treadmill walking .
RESULTS	The normalized H-reflex amplitude was lower in the swing phase for the middle-aged group , and there was no difference in muscle activity .
RESULTS	EMG/H-reflex gain did not differ between groups .
CONCLUSIONS	H-reflex amplitude during walking was affected by aging , and changes during the swing phase could be seen in the middle-aged subjects .
CONCLUSIONS	Subdividing the 2 age groups into groups of facilitated or suppressed swing-phase H-reflex revealed that the H-reflex amplitude modulation pattern in the group with facilitated swing-phase H-reflex may be influenced by aging .

###10922420
BACKGROUND	After endoscopic treatment of bleeding peptic ulcers , bleeding recurs in 15 to 20 percent of patients .
METHODS	We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers .
METHODS	Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation .
METHODS	After hemostasis had been achieved , they were randomly assigned in a double-blind fashion to receive omeprazole ( given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours ) or placebo .
METHODS	After the infusion , all patients were given 20 mg of omeprazole orally per day for eight weeks .
METHODS	The primary end point was recurrent bleeding within 30 days after endoscopy .
RESULTS	We enrolled 240 patients , 120 in each group .
RESULTS	Bleeding recurred within 30 days in 8 patients ( 6.7 percent ) in the omeprazole group , as compared with 27 ( 22.5 percent ) in the placebo group ( hazard ratio , 3.9 ; 95 percent confidence interval , 1.7 to 9.0 ) .
RESULTS	Most episodes of recurrent bleeding occurred during the first three days , which made up the infusion period ( 5 in the omeprazole group and 24 in the placebo group , P < 0.001 ) .
RESULTS	Three patients in the omeprazole group and nine in the placebo group underwent surgery ( P = 0.14 ) .
RESULTS	Five patients ( 4.2 percent ) in the omeprazole group and 12 ( 10 percent ) in the placebo group died within 30 days after endoscopy ( P = 0.13 ) .
CONCLUSIONS	After endoscopic treatment of bleeding peptic ulcers , a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding .

###18093331
BACKGROUND	Depression is a highly prevalent condition , affecting more than 15 % of the adult population at least once in their lives .
BACKGROUND	Guided self-help is effective in the treatment of depression .
BACKGROUND	The purpose of this study is to investigate the effectiveness of two Internet-based guided self-help treatments with adults reporting elevated depressive symptoms .
BACKGROUND	Other research questions concern the identification of potential mediators and the search for subgroups who respond differently to the interventions .
METHODS	This study is a randomized controlled trial with three conditions : two treatment conditions and one waiting list control group .
METHODS	The two treatment conditions are Internet-based cognitive behavior therapy and Internet-based problem-solving therapy .
METHODS	They consist of 8 and 5 weekly lessons respectively .
METHODS	Both interventions are combined with support by e-mail .
METHODS	Participants in the waiting list control group receive the intervention three months later .
METHODS	The study population consists of adults from the general population .
METHODS	They are recruited through advertisements in local and national newspapers and through banners on the Internet .
METHODS	Subjects with symptoms of depression ( > or = 16 on the Center for Epidemiological Studies Depression scale ) are included .
METHODS	Other inclusion criteria are having sufficient knowledge of the Dutch language , access to the Internet and an e-mail address .
METHODS	Primary outcome is depressive symptoms .
METHODS	Secondary outcomes are anxiety , quality of life , dysfunctional cognitions , worrying , problem solving skills , mastery , absence at work and use of healthcare .
METHODS	We will examine the following variables as potential mediators : dysfunctional cognitions , problem solving skills , worrying , anxiety and mastery .
METHODS	Potential moderating variables are : socio-demographic characteristics and symptom severity .
METHODS	Data are collected at baseline and at 5 weeks , 8 weeks , 12 weeks and 9 months after baseline .
METHODS	Analyses will be conducted on the intention-to-treat sample .
CONCLUSIONS	This study evaluates two Internet-based treatments for depression , namely cognitive behavioral therapy and problem-solving therapy .
CONCLUSIONS	The effectiveness of Internet-based problem-solving therapy suggest that this may be a worthwhile alternative to other more intensive treatment options .
CONCLUSIONS	Strengths and limitations of this study are discussed .
BACKGROUND	Current Controlled Trials ISRCTN16823487 .

###22806274
OBJECTIVE	Recent clinical trials in lupus nephritis have all used different criteria to assess complete response .
OBJECTIVE	The objective of this analysis was to compare several previously proposed criteria , using the same data set from a large trial of abatacept in lupus nephritis ( IM101075 ) .
OBJECTIVE	In so doing , we sought to determine which criteria are most sensitive to differences among treatment groups and to further examine the potential of abatacept in lupus nephritis .
METHODS	Patients in the IM101075 trial received abatacept at 1 of 2 different dose regimens or placebo , both on a background of mycophenolate mofetil and corticosteroids .
METHODS	Using data from this trial , we assessed rates of complete response at 12 months according to 5 sets of criteria , from 1 ) the trial protocol , 2 ) the Aspreva Lupus Management Study ( ALMS ) trial of mycophenolate mofetil , 3 ) the Lupus Nephritis Assessment with Rituximab ( LUNAR ) trial of rituximab , 4 ) an ongoing National Institutes of Health trial of abatacept ( Abatacept and Cyclophosphamide Combination : Efficacy and Safety Study [ ACCESS ] ) , and 5 ) published recommendations of the American College of Rheumatology .
RESULTS	According to the complete response definition from the IM101075 study protocol , there was no difference among treatment groups in the IM101075 study .
RESULTS	In contrast , according to the ALMS , LUNAR , and ACCESS criteria , rates of complete response among patients in the IM101075 study were higher in both treatment groups relative to control .
RESULTS	The largest differences were obtained with use of the LUNAR criteria ( complete response rate of 6 % in the control group , compared to 22 % and 24 % in the 2 abatacept groups ) .
CONCLUSIONS	The choice of definition of complete response can determine whether a lupus nephritis trial is interpreted as a success or a failure .
CONCLUSIONS	The results of this analysis provide an evidence-based rationale for choosing among alternative definitions and offer a strong rationale for conducting further studies of abatacept in lupus nephritis .

###24472731
BACKGROUND	Subclinical diabetic cardiomyopathy ( DCM ) is frequent in asymptomatic subjects with type 2 diabetes ( T2DM ) .
BACKGROUND	We sought the response of functional and fibrosis markers to therapy in a trial of aldosterone antagonism for treatment of DCM .
METHODS	Biochemical , anthropometric , and echocardiographic data were measured in 225 subjects with T2DM .
METHODS	Myocardial function was evaluated with standard echocardiography and myocardial deformation ; ischaemia was excluded by exercise echocardiography .
METHODS	Calibrated integrated backscatter and post-contrast T1 mapping from cardiac magnetic resonance imaging were used to assess myocardial structure .
METHODS	Amino-terminal propeptides of pro-collagen type I ( PINP ) and III ( PIIINP ) , the carboxy-terminal propeptide of pro-collagen type I ( PICP ) and transforming growth factor beta-1 were measured from peripheral blood or urine to assess myocardial collagen turnover .
RESULTS	Diastolic dysfunction was identified in 81 individuals , of whom 49 ( 25 male , age 60 10 years ) were randomized to spironolactone 25 mg/day or placebo therapy for 6 months .
RESULTS	Groups were well-matched at baseline .
RESULTS	Spironolactone therapy was associated with improvements in diastolic filling profile ( peak E wave velocity -4 15 vs. 9 10 ms , P = 0.001 ; E/A ratio -0.1 0.3 vs. 0.2 0.2 , P < 0.001 ) and cIB values ( -21.2 4.5 dB vs. -18.0 5.2 dB , P = 0.026 ; cIB -5.1 6.8 vs. -1.3 5.2 , P = 0.030 ) .
RESULTS	cIB was independently associated with spironolactone therapy ( = 0.320 , P = 0.026 ) but not blood pressure .
RESULTS	With intervention , pro-collagen biomarkers ( PINP P = 0.92 , PICP P = 0.25 , PIIINP P = 0.52 , and TGF-1 P = 0.71 ) and T1 values ( P = 0.54 ) remained similar between groups .
CONCLUSIONS	Spironolactone-induced changes in myocardial structure and diastolic properties in DCM are small , and are unassociated with changes in collagen biomarkers or T1 values .

###23620930
OBJECTIVE	To observe the clinical efficacy on sleep disorder in the intervention of flying needling therapy and compare the efficacy difference among flying needling therapy , estazolam and non-acupoint acupuncture .
METHODS	Three hundred and fifteen cases of sleep disorder were randomized into a flying needling group ( 110 cases ) , an estazolam group ( 107 cases ) and a non-acupoint acupuncture group ( 98 cases ) .
METHODS	In the flying needling group , the flying needling therapy was applied to Sanyinjiao ( SP 6 ) , Anmian ( EX HN22 ) , Shenmen ( HT 7 ) and so on .
METHODS	Additionally , vitamin B1 was prescribed for oral administration and the intradermal needle method was given at the Back-shu points .
METHODS	In the estazolam group , estazolam was prescribed for oral administration .
METHODS	Also the non-acupoint acupuncture and the acupoint sticking therapy on the Back-shu points were given additionally .
METHODS	In the non-acupoint acupuncture group , the non-acupoint acupuncture , oral administration of vitamin B1 and the acupoint sticking therapy on the Back-shu points were applied .
METHODS	The treatment of 2 weeks were required in all the groups .
METHODS	The efficacy and the score of PSQI ( Pittsburgh sleep quality index ) were observed in the 2-week follow-up visit .
RESULTS	The total effective rate in the flying needling group was 84.1 % ( 90/107 ) , which was superior to 59.7 % ( 62/104 ) in the estazolam group and 25.0 % ( 24/96 ) in the non-acupoint acupuncture group ( both P < 0.05 ) .
RESULTS	In the follow-up observation , the score of each item and the total score of PSQI were lower apparently than those before treatment in each group ( all P < 0.05 ) , and those in the flying needling group were lower apparently than those in the other two groups ( all P < 0.05 ) .
CONCLUSIONS	The flying needling therapy as the chief therapeutic method effectively improves the sleep quality for the patients with sleep disorder , which is apparently superior to estazolam and non-acupoint acupuncture .

###23365053
OBJECTIVE	The aim of our study was to test the hypothesis that ketamine would affect aura in a randomized controlled double-blind trial , and thus to provide direct evidence for the role of glutamatergic transmission in human aura .
METHODS	We performed a double-blinded , randomized parallel-group controlled study investigating the effect of 25 mg intranasal ketamine on migraine with prolonged aura in 30 migraineurs using 2 mg intranasal midazolam as an active control .
METHODS	Each subject recorded data from 3 episodes of migraine .
RESULTS	Eighteen subjects completed the study .
RESULTS	Ketamine reduced the severity ( p = 0.032 ) but not duration of aura in this group , whereas midazolam had no effect .
CONCLUSIONS	These data provide translational evidence for the potential importance of glutamatergic mechanisms in migraine aura and offer a pharmacologic parallel between animal experimental work on cortical spreading depression and the clinical problem .
METHODS	This study provides class III evidence that intranasal ketamine is effective in reducing aura severity in patients with migraine with prolonged aura .

###21306324
OBJECTIVE	Insulin resistance ( IR ) , which is common in women with polycystic ovarian syndrome ( PCOS ) , may adversely affect the outcome of ovulation induction due to its detrimental effect on ovarian function .
OBJECTIVE	The aim of this study was to evaluate the impact of IR on the outcome of laparoscopic ovarian diathermy ( LOD ) .
METHODS	Prospective observational study .
METHODS	Tertiary fertility centre .
METHODS	Forty-four anovulatory women with PCOS undergoing LOD .
METHODS	Fasting serum concentrations of insulin and glucose were measured before and after LOD .
METHODS	Insulin sensitivity was determined using the homeostasis model assessment ( HOMA ) index .
METHODS	Values of HOMA index 2.1 were considered abnormal , indicating IR .
METHODS	Ovulation and pregnancy rates were compared between women with and without IR using ( 2 ) test and odds ratio ( OR ) with 95 % confidence interval ( CI ) .
RESULTS	Eighteen women ( 41 % ) had elevated HOMA index ( 2.1 ) .
RESULTS	There was no change of HOMA index after LOD ( median 1.89 , range 0.53-8 .48 vs. 1.92 , range 0.53-8 .46 ) .
RESULTS	The ovulation rate in women with IR ( 12 of 18 , 67 % ) was significantly ( p = 0.013 , OR 0.08 ; 95 % CI 0.01-0 .74 ) lower than that ( 25 of 26 , 96 % ) of women without IR .
RESULTS	Likewise , the pregnancy rate ( six of 18 , 33 % ) was significantly ( p = 0.037 , OR 0.26 ; 95 % CI 0.07-0 .94 ) lower in women with IR than that of women without IR ( 17 of 26 , 65 % ) .
RESULTS	Using a receiver operating characteristics curve , the HOMA index was useful in predicting no ovulation after LOD ( area under the curve 0.826 ) .
CONCLUSIONS	Insulin resistance appears to have an adverse effect on the outcome of LOD and seems to be a useful prognostic factor .

###21999705
BACKGROUND	Donor site wounds after split-skin grafting are rather ` standard ' wounds .
BACKGROUND	At present , lots of dressings and topical agents for donor site wounds are commercially available .
BACKGROUND	This causes large variation in the local care of these wounds , while the optimum ` standard ' dressing for local wound care is unclear .
BACKGROUND	This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds .
METHODS	A 14-center , six-armed randomized clinical trial is being carried out in the Netherlands .
METHODS	An a-priori power analysis and an anticipated dropout rate of 15 % indicates that 50 patients per group are necessary , totaling 300 patients , to be able to detect a 25 % quicker mean time to complete wound healing .
METHODS	Randomization has been computerized to ensure allocation concealment .
METHODS	Adult patients who need a split-skin grafting operation for any reason , leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings : hydrocolloid , alginate , film , hydrofiber , silicone dressing , or paraffin gauze .
METHODS	No combinations of products from other intervention groups in this trial are allowed .
METHODS	Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers .
METHODS	Primary outcomes are days to complete wound healing and pain ( using a Visual Analogue Scale ) .
METHODS	Secondary outcomes are adverse effects , scarring , patient satisfaction , and costs .
METHODS	Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred .
METHODS	Results will be analyzed according to the intention to treat principle .
METHODS	The first patient was randomized October 1 , 2009 .
CONCLUSIONS	This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds .
CONCLUSIONS	The dressing ( s ) that will prevail in effectiveness , satisfaction and costs will be promoted among clinicians dealing with such patients .
CONCLUSIONS	Thus , we aim to contribute a well-designed trial , relevant to all clinicians involved in the care for donor site wounds , which will help enhance uniformity and quality of care for these patients .
BACKGROUND	http://www.trialregister.nl , NTR1849 .
BACKGROUND	Date registered : June 9 , 2009 .

###10586171
OBJECTIVE	To determine the effect of cranberry prophylaxis on rates of bacteriuria and symptomatic urinary tract infection in children with neurogenic bladder receiving clean intermittent catheterization .
METHODS	Double-blind , placebo-controlled , crossover study of 15 children receiving cranberry concentrate or placebo concentrate for 6 months ( 3 months receiving one concentrate , followed by 3 months of the other ) .
METHODS	Weekly home visits were made .
METHODS	During each visit , a sample of bladder urine was obtained by intermittent catheterization .
METHODS	Signs and symptoms of urinary tract infection and all medications were recorded , and juice containers were counted .
RESULTS	During consumption of cranberry concentrate , the frequency of bacteriuria remained high .
RESULTS	Cultures of 75 % ( 114 of 151 ) of the 151 samples obtained during consumption of placebo were positive for a pathogen ( > / = 10 ( 4 ) colony-forming units/mL ) compared with 75 % ( 120 of 160 ) of the 160 samples obtained during consumption of cranberry concentrate .
RESULTS	Escherichia coli remained the most common pathogen during placebo and cranberry periods .
RESULTS	Three symptomatic infections each occurred during the placebo and cranberry periods .
RESULTS	No significant difference was observed in the acidification of urine in the placebo group versus the cranberry group ( median , 5.5 and 6.0 , respectively ) .
CONCLUSIONS	The frequency of bacteriuria in patients with neurogenic bladder receiving intermittent catheterization is 70 % ; cranberry concentrate had no effect on bacteriuria in this population .

###17877648
OBJECTIVE	Inhaled human insulin ( Exubera ; EXU ) has shown encouraging tolerability in short-term trials .
OBJECTIVE	We evaluated the safety profile of EXU after long-term exposure .
METHODS	In two , open-label , 2-year studies patients poorly controlled on a sulphonylurea were randomised to adjunctive EXU or metformin ( study 1 ) and patients poorly controlled on metformin were randomised to adjunctive EXU or the sulphonylurea , glibenclamide ( study 2 ) .
METHODS	The studies included 446 ( study 1 ) and 476 ( study 2 ) patients with type 2 diabetes , no clinically significant respiratory disease and glycosylated haemoglobin ( HbA ( 1c ) ) levels of 8-12 % .
METHODS	Main outcome measures were pulmonary function tests and insulin antibody assays .
RESULTS	A total of 109 patients ( study 1 ) and 195 patients ( study 2 ) completed 104 weeks treatment .
RESULTS	In both studies , small treatment group differences in change from baseline forced expiratory volume in 1 s were greatest at 6 months ( first time-point measured ) and less at later visits , and reversed on treatment discontinuation .
RESULTS	At 2 years , differences in mean changes were -0.10 and -0.01 l in studies 1 and 2 , respectively , and -0.04 l for the pooled studies .
RESULTS	There was no discernable effect of long-term EXU therapy on pulmonary gas exchange .
RESULTS	Insulin antibody binding reached a plateau at 6 months and did not correlate with HbA ( 1c ) or lung function changes .
RESULTS	Glycaemic control was maintained over 2 years .
CONCLUSIONS	Exubera was well tolerated during long-term use .
CONCLUSIONS	Pulmonary function changes compared with comparator groups were small , non-progressive and reversed upon treatment discontinuation .
CONCLUSIONS	Importantly , rates of lung function change were indistinguishable between EXU and comparator after 6 months of therapy .

###23398978
OBJECTIVE	To compare the effectiveness of group follow-up with individual follow-up after participation in the Dose Adjustment for Normal Eating ( DAFNE ) structured education programme .
METHODS	Cluster randomised controlled trial involving 437 adults with type 1 diabetes attending hospital diabetes clinics in Ireland .
METHODS	All participants received DAFNE at baseline .
METHODS	Intervention arm participants received 2 group education sessions post-DAFNE and did not attend clinics .
METHODS	Control arm participants received 2 one-to-one clinic visits post-DAFNE .
RESULTS	We observed no significant difference in the primary outcome ( change in HbA1c ) at 18 months follow-up ( mean difference 0.14 % ; 95 % CI -0.33 to 0.61 ; p = 0.47 ) .
RESULTS	Secondary outcomes , including rates of severe hypoglycaemia , anxiety , depression , the burden of living with diabetes and quality of life did not differ between groups .
RESULTS	Mean level of HbA1c for the entire sample ( regardless of treatment arm ) did not change between baseline and 18 month follow-up ( p = 0.09 ) , but rates of severe hypoglycaemia , diabetes related hospital attendance , levels of anxiety , depression , the burden of living with diabetes , quality of life and treatment satisfaction all significantly improved .
CONCLUSIONS	Our data suggest that group follow-up as the sole means of follow-up after structured education for individuals with type 1 diabetes is as effective as a return to one-to-one clinic visits .

###24077863
OBJECTIVE	This randomized controlled trial had two main aims .
OBJECTIVE	The first aim was to investigate the effect of early preventive , psychologically informed , interventions for pain-related disability .
OBJECTIVE	The second aim was explore whether people who are matched to an intervention specifically targeting their psychological risk profile had better outcomes than people who were not matched to interventions .
METHODS	A total of 105 participants were recruited from their workplace , screened for psychological risk factors and classified as being at risk for long-term pain-related disability .
METHODS	They were subgrouped into one of three groups based on their psychological profile .
METHODS	Three behaviorally oriented psychological interventions were developed to target each of the three risk profiles .
METHODS	Half of the participants were assigned a matched intervention developed to target their specific profile , and half were assigned an unmatched intervention .
METHODS	After treatment , repeated measure ANOVAs and v2 tests were used to determine if treatments had an effect on primary and secondary outcomes including perceived disability , sick leave , fear and avoidance , pain catastrophizing and distress , and if matched participants had better outcomes than did unmatched .
RESULTS	Treatments had effects on all outcome variables ( effect sizes d ranging between 0.23 and 0.66 ) , but matched participants did not have better outcomes than unmatched .
CONCLUSIONS	Early , preventive interventions have an impact on a number of outcome variables but it is difficult to realize a matching procedure .
CONCLUSIONS	More in-depth research of the process of matching is needed .

###19917887
BACKGROUND	The Sudden Cardiac Death in Heart Failure Trial ( SCD-HeFT ) demonstrated that implantable cardioverter-defibrillator ( ICD ) therapy reduces all-cause mortality in patients with New York Heart Association class II/III heart failure and a left ventricular ejection fraction < or = 35 % on optimal medical therapy .
BACKGROUND	Whether ICD therapy reduced sudden death caused by ventricular tachyarrhythmias without affecting heart failure deaths in this population is unknown .
RESULTS	SCD-HeFT randomized 2521 subjects to placebo , amiodarone , or shock-only , single-lead ICD therapy .
RESULTS	Over a median follow-up of 45.5 months , a total of 666 deaths occurred , which were reviewed by an Events Committee and initially categorized as cardiac or noncardiac .
RESULTS	Cardiac deaths were further adjudicated as resulting from sudden death presumed to be ventricular tachyarrhythmic , bradyarrhythmia , heart failure , or other cardiac causes .
RESULTS	ICD therapy significantly reduced cardiac mortality compared with placebo ( adjusted hazard ratio , 0.76 ; 95 % confidence interval , 0.60 to 0.95 ) and tachyarrhythmia mortality ( adjusted hazard ratio , 0.40 ; 95 % confidence interval , 0.27 to 0.59 ) and had no impact on mortality resulting from heart failure or noncardiac causes .
RESULTS	The cardiac and tachyarrhythmia mortality reductions were evident in subjects with New York Heart Association class II but not in subjects with class III heart failure .
RESULTS	The reduction in tachyarrhythmia mortality with ICD therapy was similar in subjects with ischemic and nonischemic disease .
RESULTS	Compared with placebo , amiodarone had no significant effect on any mode of death .
CONCLUSIONS	ICD therapy reduced cardiac mortality and sudden death presumed to be ventricular tachyarrhythmic in SCD-HeFT and had no effect on heart failure mortality .
CONCLUSIONS	Amiodarone had no effect on all-cause mortality or its cause-specific components , except an increase in non-cardiac mortality in class III patients .
CONCLUSIONS	[ corrected ]
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00000609 .

###19733827
BACKGROUND	Six major pharmaceutical products were withdrawn from the market from 2000 to 2006 .
BACKGROUND	Little evidence exists in understanding consumer reactions to such events and the influence the withdrawal has on its competitors .
OBJECTIVE	To explore consumers ' attribution of blame after pharmaceutical product market withdrawal ( PPMW ) and its effect on trust .
METHODS	Subjects were assigned randomly to 4 groups and provided a unique hypothetical PPMW scenario and asked to imagine themselves in the situation described .
METHODS	Each scenario represented a different `` distance '' from the PPMW ( eg , whether subjects were asked to assume they were taking the withdrawn drug or a therapeutic substitute ) .
METHODS	Blame of and trust in several key professionals/groups were measured .
RESULTS	Closer `` distance '' to the PPMW resulted in higher blame attributions for the Food and Drug Administration ( FDA ) , pharmaceutical company ( Pharma ) , and the physician .
RESULTS	Although the pattern of trust scores did not differ based on `` distance , '' insurance companies and Pharma suffered from low trust , whereas pharmacists and physicians received higher trust ratings .
RESULTS	Blaming appeared to be no different between consumers on a withdrawn product and those consumers on a product in the same therapeutic class ( `` substitute '' product ) .
CONCLUSIONS	Substitute products ( drugs in the same therapeutic class ) appear to be affected in the event of a PPMW , although drugs used to treat the same disease do not appear to be so affected .
CONCLUSIONS	The difficult-to-explain findings with respect to trust may be accounted for by the fact that trust is more downstream than blame ( based on the scenario presentations ) and that trust is a complex construct with multiple antecedents .
CONCLUSIONS	Although the bonds of interpersonal trust remain stronger than those of institutional trust , the likelihood of situational trust versus overall trust may complicate this picture of understanding trust .
CONCLUSIONS	It may be possible that trust is impervious to this one negative instance versus many positive interactions .

###10513507
OBJECTIVE	This study compares the responsiveness and relative effect sizes of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) with the Medical Outcomes Study Short Form Health Survey ( SF-36 ) in a randomized clinical trial for treatment of osteoarthritis ( OA ) .
METHODS	Patients with OA of the knee or hip were randomized to receive either placebo or 2,400 mg/day of ibuprofen for 28 days .
METHODS	Patients completed the WOMAC and SF-36 at baseline and days 7 , 14 , and 28 of the trial .
RESULTS	Patients receiving ibuprofen showed significant improvement in WOMAC pain , physical functioning , and the total score , while improvement was detected only for bodily pain on the SF-36 .
RESULTS	The WOMAC detected significant differences between ibuprofen and placebo for pain and physical functioning , whereas the SF-36 detected differences for the bodily pain subscale .
CONCLUSIONS	These results suggest the WOMAC has greater power to detect treatment differences than the SF-36 , with respect to pain and physical functioning , in OA clinical trials .

###15602019
BACKGROUND	Oral mucositis is a complication of intensive chemotherapy and radiotherapy with no effective treatment .
BACKGROUND	We tested the ability of palifermin ( recombinant human keratinocyte growth factor ) to decrease oral mucosal injury induced by cytotoxic therapy .
METHODS	This double-blind study compared the effect of palifermin with that of a placebo on the development of oral mucositis in 212 patients with hematologic cancers ; 106 patients received palifermin ( 60 microg per kilogram of body weight per day ) and 106 received a placebo intravenously for three consecutive days immediately before the initiation of conditioning therapy ( fractionated total-body irradiation plus high-dose chemotherapy ) and after autologous hematopoietic stem-cell transplantation .
METHODS	Oral mucositis was evaluated daily for 28 days after transplantation .
RESULTS	The incidence of oral mucositis of World Health Organization ( WHO ) grade 3 or 4 was 63 percent in the palifermin group and 98 percent in the placebo group ( P < 0.001 ) .
RESULTS	Among patients with this degree of mucositis , the median duration of mucositis was 6 days ( range , 1 to 22 ) in the palifermin group and 9 days ( range , 1 to 27 ) in the placebo group .
RESULTS	Among all patients , regardless of the occurrence of mucositis , the median duration of oral mucositis of WHO grade 3 or 4 was 3 days ( range , 0 to 22 ) in the palifermin group and 9 days ( range , 0 to 27 ) in the placebo group ( P < 0.001 ) .
RESULTS	As compared with placebo , palifermin was associated with significant reductions in the incidence of grade 4 oral mucositis ( 20 percent vs. 62 percent , P < 0.001 ) , patient-reported soreness of the mouth and throat ( area-under-the-curve score , 29.0 [ range , 0 to 98 ] vs. 46.8 [ range , 0 to 110 ] ; P < 0.001 ) , the use of opioid analgesics ( median , 212 mg of morphine equivalents [ range , 0 to 9418 ] vs. 535 mg of morphine equivalents [ range , 0 to 9418 ] , P < 0.001 ) , and the incidence of use of total parenteral nutrition ( 31 percent vs. 55 percent , P < 0.001 ) .
RESULTS	Adverse events , mainly rash , pruritus , erythema , mouth and tongue disorders , and taste alteration , were mild to moderate in severity and were transient .
CONCLUSIONS	Palifermin reduced the duration and severity of oral mucositis after intensive chemotherapy and radiotherapy for hematologic cancers .

###22612557
OBJECTIVE	To explore whether improvements in physical activity following the MobileMums intervention were mediated by changes in Social Cognitive Theory ( SCT ) constructs targeted in the intervention ( barrier self efficacy , goal setting skills , outcome expectancy , social support , and perceived environmental opportunity for exercise ) .
OBJECTIVE	This paper also examined if the mediating constructs differed between initial ( baseline to 6 weeks ) and overall ( baseline to 13 weeks ) changes in physical activity .
METHODS	Secondary analysis of data from a randomized controlled trial involving 88 postnatal women ( < 12 months postpartum ) .
METHODS	Participants were randomized to receive either the 12-week MobileMums intervention or a minimal-contact control condition .
METHODS	Physical activity and proposed mediators were assessed by self-report at baseline , 6 weeks , and 13 weeks .
METHODS	Walking for Exercise frequency was assessed using the Australian Women 's Activity Survey and frequency of moderate-to-vigorous physical activity ( MVPA ) was assessed using a single-item question .
RESULTS	Initial improvements in goal-setting skills mediated the relationship between experimental condition and initial changes in MVPA , ( 95 % CI ) = 0.23 ( 0.01 , 0.59 ) , and Walking for Exercise , ( 95 % CI ) = 0.34 ( 0.06 , 0.73 ) .
RESULTS	Initial improvements in barrier self efficacy mediated the relationship between experimental condition and initial change in MVPA , ( 95 % CI ) = 0.36 ( 0.12 , 0.65 ) , but not Walking for Exercise .
RESULTS	None of the SCT outcomes significantly mediated the relationship between experimental condition and overall ( baseline to 13 weeks ) change in frequency of MVPA or Walking for Exercise .
CONCLUSIONS	Future interventions with postnatal women using SCT should target barrier self-efficacy and goal setting skills in order to increase physical activity .

###21029892
OBJECTIVE	To compare the intraoperative and postoperative outcomes of conventional longitudinal phacoemulsification and torsional phacoemulsification .
METHODS	Department of Ophthalmology , University of Leipzig , Germany .
METHODS	Randomized single-center clinical trial .
METHODS	Eyes with senile cataract were randomized to have phacoemulsification using the Infiniti Vision System and the torsional mode ( OZil ) or conventional longitudinal mode .
METHODS	Primary outcomes were corrected distance visual acuity ( CDVA ) and central endothelial cell density ( ECD ) , calculated according to the Conference on Harmonisation-E9 Guidelines in which missing values were substituted by the median in each group ( primary analysis ) and the loss was then calculated using actual data ( secondary analysis ) .
METHODS	Secondary outcomes were ultrasound ( US ) time , cumulative dissipated energy ( CDE ) , and percentage total equivalent power in position 3 .
METHODS	Postoperative follow-up was at 3 months .
RESULTS	The mean preoperative CDVA was 0.41 logMAR in the torsional group and 0.38 logMAR in the longitudinal group , improving to 0.07 logMAR postoperatively in both groups .
RESULTS	The mean ECD loss was 7.2 % 4.6 % in the torsional group ( 72 patients ) and 7.1 % 4.4 % in the longitudinal group ( 76 patients ) , with no statistically significant differences in the primary analysis ( P = .342 ) or secondary analysis ( P = .906 ) .
RESULTS	The mean US time , CDE , and percentage total equivalent power in position 3 were statistically significantly lower in the torsional group ( 98 patients ) than in the longitudinal group ( 94 patients ) ( P < .001 ) .
CONCLUSIONS	The torsional mode was as safe as the longitudinal mode in phacoemulsification for age-related cataract .

###17661847
OBJECTIVE	The aim of the study was to investigate the influence of highly active antiretroviral therapy ( HAART ) on iron status and , conversely , the influence of iron status on the response to HAART .
METHODS	Ferritin levels were retrospectively determined in stored plasma from 138 HAART-nave , moderately immunosuppressed HIV-infected Thai patients participating in a structured treatment interruption trial .
METHODS	Ferritin levels were determined at three predefined time-points : ( 1 ) HAART initiation ; ( 2 ) HAART discontinuation ; and ( 3 ) HAART resumption .
RESULTS	At baseline , 31 % and 16 % of the HIV-infected patients included in the study had high ( > 200 ng/mL ) and low ( < 30 ng/mL ) ferritin levels , respectively .
RESULTS	Ninety-five per cent of patients with low ferritin levels were female .
RESULTS	Ferritin decreased significantly during the interruption phase of HAART ( -8.8 ng/mL ; P = 0.0005 ) but remained elevated in 62 % of the patients with high baseline levels .
RESULTS	A low baseline ferritin level was associated with a shorter time ( P = 0.041 ) to reach the CD4 cell target for HAART interruption ( 350 cells/microL ) , compared with a normal or high baseline ferritin level .
RESULTS	Moreover , in a multivariate model , the relative risk ( RR ) of arriving at this CD4 cell target was significantly higher [ RR 1.81 ; 95 % confidence interval ( CI ) 1.05-3 .14 ] in patients with low baseline ferritin .
RESULTS	It is unlikely that inflammation affected ferritin in our patients , as mean levels of C-reactive protein were not elevated in patients with either high or low ferritin levels .
CONCLUSIONS	Both high and low ferritin levels were highly prevalent in moderately immunosuppressed HIV-positive Thai patients .
CONCLUSIONS	Structured treatment interruption of HAART resulted in a significant decrease in overall ferritin levels .
CONCLUSIONS	Furthermore , subjects with low baseline ferritin levels had a faster and greater CD4 response to HAART , suggesting a potential beneficial effect of iron deficiency on immunological recovery after initiation of HAART .

###21829006
OBJECTIVE	To compare the efficacy and safety of single-injection inferomedial ( IM ) and conventional inferotemporal ( IT ) peribulbar blockades .
METHODS	This prospective randomized study included 200 patients who were randomly allocated into two equal groups ( n = 100 patients ) ; in the first group , patients received IM peribulbar injection ( IM group ) , while IT peribulbar injection was performed for the second group ( IT group ) .
METHODS	The measurement data were patient characteristics , number of patients who required supplementations , total anesthetic volume injected , surgeon 's experience and any recordable complications .
RESULTS	The number of patients who required supplemental anesthetics due to inadequate block was significantly higher in the IT group ( 15 patients , 15 % , vs. no patients , 0 % , in the IM group ) .
RESULTS	The total anesthetic volume injected was significantly lower in the IM group ( 5.6 0.8 vs. 9.8 0.7 ml in the IT group ) .
RESULTS	Surgeon 's satisfaction was significantly higher in the IM group ( 100 vs. 22 % in the IT group ) .
RESULTS	The incidences of complications were not significantly different between the two groups .
CONCLUSIONS	It is safe and effective to conduct single-injection IM peribulbar blockade using a small needle size and low anesthetic volume .

###18223492
OBJECTIVE	Alterations in bone metabolism in primary biliary cirrhosis ( PBC ) are generally considered to be highly prevalent and severe , but no data are available from prospective studies with adequate control groups .
OBJECTIVE	The aims of this study were : ( 1 ) to measure changes in bone mineral density ( BMD ) over time ; ( 2 ) to correlate the degree of bone loss with the severity of liver disease ; and ( 3 ) to characterize bone disease in PBC patients receiving regular calcium and vitamin D supplementation .
METHODS	We enrolled 118 women with PBC ( mean age + / - SD : 56 + / -11 y ; 72 % postmenopausal ; 43 % with cirrhosis ) , and measured BMD ( lumbar spine , DXA-Hologic ) at entry and serially over the following 5 years .
METHODS	The controls were 472 healthy women selected from a large observational group matched for age and menopausal status ( mean age + / - SD : 55 + / -10 y ; 73 % postmenopausal ) .
RESULTS	Mean BMD was 0.851 + / -0.142 g/cm2 in the PBC group and 0.857 + / -0.158 g/cm2 in the control group ; the prevalence of osteoporosis was 28 % and 29 % , respectively .
RESULTS	BMD significantly correlated with age and postmenopausal status , but not with liver cirrhosis or serum bilirubin levels .
RESULTS	The biochemical markers of bone turnover were high in about 50 % of the patients .
RESULTS	The yearly bone loss in the PBC group was 0.008 g/cm2 ( 95 % confidence interval : 0.014-0 .003 ) similar to that calculated in the control group .
CONCLUSIONS	Among patients with PBC , the prevalence of osteoporosis and the yearly rate of BMD loss are similar to those observed in the general population , and are not associated with the severity of liver disease .

###19910834
OBJECTIVE	This study was designed to evaluate the effects of total enteral nutrition and total parenteral nutrition in prevention of pancreatic necrotic infection in severe acute pancreatitis .
METHODS	One hundred seven patients were enrolled in the study between 2003 and 2007 .
METHODS	In the first week of hospitalization , they were randomized to feeding by either total parenteral nutrition ( 54 patients ) or total enteral nutrition ( 53 patients ) .
METHODS	All patients were concomitantly administered with sufficient prophylactic antibiotics .
METHODS	Computed tomographic scan and C-reactive protein level indicated a similar clinical severity in both groups .
RESULTS	Eighty percent of the patients developed organ failure in the group with total parenteral nutrition , which was higher than that in the group with total enteral nutrition ( 21 % ) .
RESULTS	Eighty percent and 22 % ( P < 0.05 ) of the patients in the total parenteral nutrition and total enteral nutrition groups , respectively , underwent surgical intervention .
RESULTS	The incidence of pancreatic septic necroses in the group with total enteral nutrition ( 23 % ) was lower than that in the group with total parenteral nutrition ( 72 % , P < 0.05 ) .
RESULTS	Mortality in the total parenteral nutrition group ( 43 % ) was higher than in the total enteral nutrition group ( 11 % , P < 0.05 ) .
CONCLUSIONS	Total enteral nutrition is better than total parenteral nutrition in the prevention of pancreatic necrotic infection in severe acute pancreatitis .

###22039966
BACKGROUND	Children with tuberculosis often have underlying nutritional deficiencies .
BACKGROUND	Multivitamin supplementation has been proposed as a means to enhance the health of these children ; however , the efficacy of such an intervention has not been examined adequately .
METHODS	255 children , aged six weeks to five years , with tuberculosis were randomized to receive either a daily multivitamin supplement or a placebo in the first eight weeks of anti-tuberculous therapy in Tanzania .
METHODS	This was only 64 % of the proposed sample size as the trial had to be terminated prematurely due to funding constraints .
METHODS	They were followed up for the duration of supplementation through clinic and home visits to assess anthropometric indices and laboratory parameters , including hemoglobin and albumin .
RESULTS	There was no significant effect of multivitamin supplementation on the primary endpoint of the trial : weight gain after eight weeks .
RESULTS	However , significant differences in weight gain were observed among children aged six weeks to six months in subgroup analyses ( n = 22 ; 1.08 kg , compared to 0.46 kg in the placebo group ; 95 % CI = 0.12 , 1.10 ; p = 0.01 ) .
RESULTS	Supplementation resulted in significant improvement in hemoglobin levels at the end of follow-up in children of all age groups ; the median increase in children receiving multivitamins was 1.0 g/dL , compared to 0.4 g/dL in children receiving placebo ( p < 0.01 ) .
RESULTS	HIV-infected children between six months and three years of age had a significantly higher gain in height if they received multivitamins ( n = 48 ; 2 cm , compared to 1 cm in the placebo group ; 95 % CI = 0.20 , 1.70 ; p = 0.01 ; p for interaction by age group = 0.01 ) .
CONCLUSIONS	Multivitamin supplementation for a short duration of eight weeks improved the hematological profile of children with tuberculosis , though it did n't have any effect on weight gain , the primary outcome of the trial .
CONCLUSIONS	Larger studies with a longer period of supplementation are needed to confirm these findings and assess the effect of multivitamins on clinical outcomes including treatment success and growth failure .
CONCLUSIONS	CLINICALTRIALS.GOV IDENTIFIER : NCT00145184 .

###7482644
OBJECTIVE	Stroke unit rehabilitation tends to be directed toward stroke patients with moderately severe disabilities ( `` the middle group '' ) .
OBJECTIVE	Data collected on a stroke rehabilitation unit , however , showed improving outcome over 3 years in patients with a poor prognosis ( discharge home : 48 % versus 16 % , P < .02 ; discharge Barthel Index score : 9 versus 6 , P < .05 ) .
OBJECTIVE	The hypothesis that stroke rehabilitation units may improve outcome in severely disabled stroke patients was tested in this study .
METHODS	A randomized controlled study was undertaken in 71 patients with a poor prognosis who were treated either on a stroke rehabilitation unit ( n = 34 ) or on general wards ( n = 37 ) to compare outcome between the two groups .
METHODS	Data collected were also compared with those from a methodologically similar study undertaken 3 years ago .
RESULTS	Severe stroke patients treated on the stroke rehabilitation unit had a significantly better outcome compared with general wards ( mortality : 21 % versus 46 % , P < .05 ; discharge home 47 % versus 19 % , P < .01 ; median length of hospital stay : 43 versus 59 days , P < .02 ) .
RESULTS	The number of stroke unit patients being discharged home had increased significantly from the previous study , with a trend toward improvement in median discharge Barthel Index score .
CONCLUSIONS	Stroke rehabilitation units may improve outcome in severe stroke patients .
CONCLUSIONS	This improvement appears to be due to the development of innovative management strategies that reduce mortality and institutionalization and enable caregivers to support more disabled stroke patients at home .

###21077956
BACKGROUND	Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients , yet there is a paucity of studies testing interventions in this area .
METHODS	Using a randomized controlled trial design , 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring .
METHODS	Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management .
METHODS	The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person 's life routines , important people , and possible solutions to enhance medication taking .
METHODS	The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring .
RESULTS	The mean medication adherence score for the continuous self-improvement intervention group ( n = 8 ) was statistically significantly higher than the attention control group 's ( n = 5 ) mean medication adherence score ( p = 0.03 ) .
RESULTS	The continuous self-improvement intervention effect size ( Cohen 's d ) was large at 1.4 .
RESULTS	Participants ' perceptions of the intervention were highly favorable .
CONCLUSIONS	The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients .
CONCLUSIONS	A fully-powered study with a diverse sample is needed to confirm these preliminary findings .

###9403284
OBJECTIVE	In a randomized cross-over study , we assessed pharmacokinetics and intracellular concentrations in polymorphonuclear leukocytes ( PMN ) and saliva of erythromycin and erythromycylamine , the active metabolite of dirithromycin .
METHODS	Ten healthy volunteers received 1 g erythromycin b.i.d. or 500 mg dirithromycin qd for 5 days ( wash out period , 35 days ) .
METHODS	Concentrations of erythromycin and erythromycylamine were measured in serum , urine , saliva , and granulocytes by bioassay and high-performance liquid chromatography ( HPLC ) on days 1 , 3 , and 5 of each study period , respectively .
RESULTS	While maximal serum concentrations ( Cmax ) and the area under the data ( AUDtot ) of erythromycin were significantly higher ( Cmax 1.44 mg.l-1 , AUDtot 5.66 mg.h.l-1 ) than those of erythromycylamine ( Cmax 0.29 mg.l-1 , AUDtot 1.96 mg.h.l-1 ) , erythromycylamine had a significantly higher mean residence time ( 21 h ) than erythromycin ( 5.5 h ) .
RESULTS	Erythromycylamine accumulated significantly more in PMN than erythromycin ; the accumulation factor of erythromycylamine was 100 with a maximal intracellular concentration of 13.4 mg.l-1 , whereas the maximal accumulation factor of erythromycin was 4 with a maximal intracellular concentration of 6.1 mg.l-1 .
RESULTS	There were no significant differences in maximal saliva concentrations ( erythromycin 0.35 mg.l-1 , erythromycylamine 0.31 mg.l-1 ) .

###21059778
BACKGROUND	Recent studies have reported a high prevalence of relative adrenal insufficiency in patients with liver cirrhosis .
BACKGROUND	However , the effect of corticosteroid replacement on mortality in this high-risk group remains unclear .
BACKGROUND	We examined the effect of low-dose hydrocortisone in patients with cirrhosis who presented with septic shock .
METHODS	We enrolled patients with cirrhosis and septic shock aged 18 years or older in a randomized double-blind placebo-controlled trial .
METHODS	Relative adrenal insufficiency was defined as a serum cortisol increase of less than 250 nmol/L or 9 g/dL from baseline after stimulation with 250 g of intravenous corticotropin .
METHODS	Patients were assigned to receive 50 mg of intravenous hydrocortisone or placebo every six hours until hemodynamic stability was achieved , followed by steroid tapering over eight days .
METHODS	The primary outcome was 28-day all-cause mortality .
RESULTS	The trial was stopped for futility at interim analysis after 75 patients were enrolled .
RESULTS	Relative adrenal insufficiency was diagnosed in 76 % of patients .
RESULTS	Compared with the placebo group ( n = 36 ) , patients in the hydrocortisone group ( n = 39 ) had a significant reduction in vasopressor doses and higher rates of shock reversal ( relative risk [ RR ] 1.58 , 95 % confidence interval [ CI ] 0.98-2 .55 , p = 0.05 ) .
RESULTS	Hydrocortisone use was not associated with a reduction in 28-day mortality ( RR 1.17 , 95 % CI 0.92-1 .49 , p = 0.19 ) but was associated with an increase in shock relapse ( RR 2.58 , 95 % CI 1.04-6 .45 , p = 0.03 ) and gastrointestinal bleeding ( RR 3.00 , 95 % CI 1.08-8 .36 , p = 0.02 ) .
CONCLUSIONS	Relative adrenal insufficiency was very common in patients with cirrhosis presenting with septic shock .
CONCLUSIONS	Despite initial favourable effects on hemodynamic parameters , hydrocortisone therapy did not reduce mortality and was associated with an increase in adverse effects .
CONCLUSIONS	( Current Controlled Trials registry no .
CONCLUSIONS	ISRCTN99675218 . )

###16996618
OBJECTIVE	To determine the success of two transnasally endoscopic assisted procedures as balloon dilatation and bicanalicular silicone tube intubation for the primary surgical treatment of congenital nasolacrimal duct obstruction in children older than 3 years .
METHODS	Prospective randomized clinical trial .
METHODS	An interventional case series of consecutive primary endoscopic assisted balloon dilatation ( BD ) and bicanalicular silicone tube intubation ( STI ) for congenital nasolacrimal duct obstruction in children older than 3 years was reviewed .
METHODS	BD was performed in 20 eyes of 17 patients and STI was performed 24 eyes of 20 patients .
METHODS	Clinical success was defined as a complete remission of epiphora at the end of follow-up period of 12 months and a continuation of the remission at least for 4 months .
RESULTS	Eighteen out of 20 eyes ( 90 % ) nasolacrimal ducts responded to BD whereas the rate was 15 out of 24 eyes ( 62.5 % ) in STI group .
RESULTS	No significant complications occured in BD group while the complication rate in STI group was 8 out of 24 eyes ( 33.3 % ) .
RESULTS	chi ( 2 ) - Statistical analysis showed significantly better results for BD in clinical success and complication rates than those of STI .
CONCLUSIONS	BD should be the first choice therapy instead of invasive approaches with high rate of complications and lower success rates such as silicone intubation , in patients who are older than 3 years .

###2742247
OBJECTIVE	To examine the effects of targeted inspiratory muscle training on respiratory muscle function , clinical ratings of dyspnea , and perception of resistive loads in symptomatic patients with chronic obstructive pulmonary disease .
METHODS	Randomized , placebo-controlled trial with an 8-week treatment period .
METHODS	Outpatient pulmonary clinic and pulmonary function laboratory .
METHODS	We studied 19 patients with moderate to severe chronic obstructive pulmonary disease , assigning 10 patients to an experimental group and 9 to a control group .
METHODS	Patients in both groups trained for 15 minutes twice each day using a device that provided breath-to-breath visual feedback of training intensity .
METHODS	Patients in the experimental group trained at six increasing levels of inspiratory resistance , whereas the patients in the control group trained at a constant , nominal level of resistance .
RESULTS	Although there was no statistically discernible difference in the effects of targeted muscle training on the mean difference in maximal inspiratory pressures between the two groups ( 9.83 cm H2O ; 95 % CI , -7.37 to 27.03 ) , patients in the experimental group did show a significant increase in inspiratory muscle strength ( 15.03 cm H2O ; P = 0.01 ) .
RESULTS	Experimental subjects also had decreased dyspnea after 8 weeks of training compared with control subjects ( P = 0.003 ) .
RESULTS	Improvements in physiologic values and in dyspnea ratings were correlated .
RESULTS	The perception of added resistive loads was not affected by inspiratory muscle training .
CONCLUSIONS	Targeted inspiratory muscle training may enhance respiratory muscle function and reduce dyspnea in symptomatic patients with moderate to severe chronic obstructive pulmonary disease .

###18823458
BACKGROUND	Systemic inflammatory response frequently occurs after coronary artery bypass surgery and is strongly correlated with the risk of postoperative morbidity and mortality .
BACKGROUND	This study tests the hypothesis that the priming of the extracorporeal circuit with colloid solutions results in less inflammation in patients undergoing cardiac surgery than priming with crystalloid solutions .
METHODS	A prospective , randomized study was designed .
METHODS	Forty-four patients undergoing elective coronary artery bypass grafting were randomly allocated to one of two groups : 22 patients primed with Ringer 's lactate ( RL ) solution and 22 patients primed with gelatin-containing solution during the surgery .
METHODS	Plasma levels of interleukin ( IL ) -6 , IL-8 , tumor necrosis factor ( TNF ) - alpha , C-reactive protein ( CRP ) and , complement 4 were measured during the surgical intervention and over the following 48 postoperative hours .
METHODS	Cytokine levels were measured by enzyme-linked assays from plasma samples obtained at specific time points pre - and post-operatively .
RESULTS	In both groups the serum levels of the pro-inflammatory cytokines ( IL-6 , IL-8 , TNF-alpha ) , CRP , complement 4 , and leukocytes increased significantly over the baseline , although no significant differences were observed between the two groups .
RESULTS	The operation time , blood loss , need for inotropic support , extubation time , and length of intensive care unit stay did not differ significantly between the two groups .
CONCLUSIONS	Priming with gelatin vs. RL produces no significant differences in the inflammatory response in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass .

###22683257
OBJECTIVE	We investigated whether antioxidant therapy reduces pain and improves quality of life in patients with chronic pancreatitis .
METHODS	We performed a double-blind , randomized , controlled trial that compared the effects of antioxidant therapy with placebo in 70 patients with chronic pancreatitis .
METHODS	Patients provided 1 month of baseline data and were followed for 6 months while receiving either antioxidant therapy ( Antox version 1.2 , Pharma Nord , Morpeth , UK ) or matched placebo ( 2 tablets , 3 times/day ) .
METHODS	The primary analysis was baseline-adjusted change in pain score at 6 months , assessed by an 11-point numeric rating scale .
METHODS	Secondary analyses included alternative assessments of clinical and diary pain scores , scores on quality-of-life tests ( the European Organization for Research and Treatment of Cancer [ EORTC-QLQ-C30 ] , Quality of Life Questionnaire-Pancreatic modification [ QLQ-PAN28 ] , European Quality of Life questionnaire [ EuroQOL EQ-5D ] , and European Quality of Life questionnaire - Visual Analog Score [ EQ-VAS ] ) , levels of antioxidants , use of opiates , and adverse events .
METHODS	Analyses , reported by intention to treat , were prospectively defined by protocol .
RESULTS	After 6 months , pain scores reported to the clinic were reduced by 1.97 from baseline in the placebo group and by 2.33 in the antioxidant group but were similar between groups ( -0.36 ; 95 % confidence interval [ CI ] , -1.44 to 0.72 ; P = .509 ) .
RESULTS	Average daily pain scores from diaries were also similar ( 3.05 for the placebo group and 2.93 for the antioxidant group , a difference of 0.11 ; 95 % CI , 1.05-0 .82 ; P = .808 ) .
RESULTS	Measures of quality of life were similar between groups , as was opiate use and number of hospital admissions and outpatient visits .
RESULTS	Blood levels of vitamin C and E , - carotene , and selenium were increased significantly in the antioxidant group .
CONCLUSIONS	Administration of antioxidants to patients with painful chronic pancreatitis of predominantly alcoholic origin does not reduce pain or improve quality of life , despite causing a sustained increase in blood levels of antioxidants .

###20357486
BACKGROUND	Polymerised allergenic extracts ( allergoids ) are commonly used in allergen immunotherapy .
BACKGROUND	Clinical efficacy and safety of these extracts have been demonstrated .
BACKGROUND	Recently , allergen sequences have been identified by mass spectrometry in depigmented and polymerised ( Dpg-Pol ) extracts .
BACKGROUND	The objectives of this study were to investigate the presence of allergens in Dpg-Pol extracts of house dust mite and to analyze the immunological changes induced by these extracts in asthmatic patients enrolled in a double-blind , placebo-controlled study .
METHODS	Dpg-Pol extracts were manufactured and vaccines with a composition of 50 % Dermatophagoides pteronyssinus and 50 % D. farinae ( 100 HEPL/ml ) were prepared .
METHODS	Allergen composition was analyzed by mass spectrometry .
METHODS	Patients with asthma and rhinoconjunctivitis were treated in a 1-year , double-blind , placebo-controlled , parallel-group study with 6 up-dosing and monthly maintenance injections .
METHODS	Specific IgE and IgG4 titres to D. pteronyssinus , Der p 1 and Der p 2 were measured in patients ' sera using the CAP system and direct ELISA experiments .
RESULTS	Sequences from the major allergens Der p 1 and Der p 2 and from other allergens were identified in native and Dpg-Pol extracts .
RESULTS	There was a statistically significant increase in specific IgG4 , a decrease in the ratio of IgE/IgG4 to D. pteronyssinus and a significant increase in specific IgG4 to Der p 1 and Der p 2 in the patients allotted to active treatment .
CONCLUSIONS	The detection of allergen sequences suggests preservation of major and minor allergens in Dpg-Pol allergoids from house dust mites .
CONCLUSIONS	Efficacy in asthma treatment and the increase in specific IgG4 seem to be associated with the presence of major allergens in Dpg-Pol allergen extracts .

###8942551
BACKGROUND	Stereotactic breast biopsy has been developed as a less invasive means of performing biopsy for mammographic abnormalities .
METHODS	From July 1994 through June 1995 , 103 women with mammographic abnormalities requiring biopsy were prospectively evaluated .
RESULTS	Fifty-one women had open biopsy , and 52 women had stereotactic biopsy .
RESULTS	The average age in both groups was 60 years .
RESULTS	Pathology revealed malignancy in 12 % of stereotactic biopsies and 13 % of open biopsies .
RESULTS	Complications occurred in 6 % of the open biopsies and 4 % of the stereotactic biopsies and were limited to hematomas or seromas .
RESULTS	The average cost was $ 2400 for open biopsy and $ 650 for stereotactic biopsy ( P < 0.01 ) .
RESULTS	One hundred and one patients returned for a follow-up mammogram within 6 months , and 1 patient in each group required a second biopsy , which revealed benign pathology .
RESULTS	A Patient Satisfaction Survey revealed no significant differences in patient satisfaction between the two types of procedures .
CONCLUSIONS	There were no differences between open and stereotactic biopsies in regards to diagnostic accuracy , complications , or patient satisfaction .
CONCLUSIONS	A significant difference was noted in charges during the time frame of our study .

###15121563
OBJECTIVE	To measure the effect of 24 months of depot medroxyprogesterone acetate use on bone mineral density compared with oral contraception ( pills ) and nonhormonal contraception .
METHODS	Women aged 18-33 years self-selected oral contraception , depot medroxyprogesterone acetate , or nonhormonal contraception ( controls ) .
METHODS	Those selecting pills were randomized to formulations containing either 35 microg ethinyl estradiol and norethindrone or 30 microg ethinyl estradiol and desogestrel .
METHODS	Controls were frequency matched on age and race/ethnicity to hormonal contraception users .
METHODS	Dual-energy X-ray absorptiometry of the lumbar spine ( L1-L4 ) was performed at baseline , 12 months , and 24 months .
METHODS	Percent change in bone mineral density was analyzed by using analysis of covariance , adjusting for age , race/ethnicity , weight-bearing exercise , calcium intake , smoking status , and body mass index .
RESULTS	Of the 191 women making up the final sample , 86 used pills , 47 used depot medroxyprogesterone acetate , and 58 used nonhormonal contraception .
RESULTS	Women using depot medroxyprogesterone acetate for 24 months experienced , on average , a 5.7 % loss in bone mineral density , with a 3.2 % loss occurring between months 12 and 24 .
RESULTS	On average , users of desogestrel pills experienced a 2.6 % loss in bone mineral density after 24 months .
RESULTS	Bonferroni-adjusted pairwise comparisons demonstrated that bone mineral density changes from baseline to 24 months among depot medroxyprogesterone acetate users differed significantly from changes experienced by either of the pill groups or the control group .
RESULTS	Changes in bone mineral density among users of either pill did not significantly differ from each other or from controls .
CONCLUSIONS	Loss of bone mineral density associated with depot medroxyprogesterone acetate use appears to be linear during the first 2 years of use .
CONCLUSIONS	Shifts in bone mineral density among pill users were not significant when compared with controls .

###23300117
OBJECTIVE	To assess the effect of golimumab , with or without methotrexate ( MTX ) , on serum lipids and inflammatory markers of cardiovascular disease ( CVD ) in patients with rheumatoid arthritis ( RA ) in two phase 3 , randomised , placebo-controlled trials ( GO-BEFORE and GO-FORWARD ) .
METHODS	Patients in GO-BEFORE ( n = 637 , MTX-nave ) and GO-FORWARD ( n = 444 , MTX-inadequate response ) were randomised to placebo + MTX , golimumab 100 mg + placebo , golimumab 50 mg + MTX , or golimumab 100 mg + MTX .
METHODS	Subcutaneous injections ( placebo and golimumab ) were given every 4 weeks .
METHODS	Patients with an insufficient response entered early escape at week 16 ( GO-FORWARD ) or 28 ( GO-BEFORE ) .
METHODS	All placebo + MTX patients in GO-FORWARD crossed over to golimumab 50 mg + MTX at week 24 .
METHODS	Changes from baseline to weeks 14 ( GO-FORWARD ) or 24 ( GO-BEFORE ) , and 52 in serum lipid levels and inflammatory markers were assessed .
RESULTS	At week 14 in the GO-FORWARD trial , total cholesterol ( TC ) , high-density lipoprotein ( HDL ) and low-density lipoprotein ( LDL ) increased in golimumab + MTX patients versus MTX-only patients ( 16.00 vs 2.00 ( p < 0.001 ) ; 3.00 vs 0.00 ( p < 0.05 ) ; 8.00 vs 4.00 ( p < 0.001 ) ; respectively ) ; favourable changes in LDL subfractions were only observed in golimumab-treated patients .
RESULTS	At week 24 in GO-BEFORE , TC and LDL increased , and LDL subfractions improved in the MTX-only and golimumab + MTX groups .
RESULTS	Inflammatory markers of CVD risk improved significantly with golimumab + MTX versus placebo + MTX in both studies and were generally maintained through week 52 .
RESULTS	Atherogenic indices were generally stable .
CONCLUSIONS	While TC and LDL levels increased mildly in RA patients receiving golimumab + MTX , atherogenic indices generally remained stable , favourable changes in LDL subfractions were observed , and inflammatory markers improved .

###24722260
BACKGROUND	The 2-adrenergic agonist dexmedetomidine is a sedative and can be used as an adjunct to anesthetics .
BACKGROUND	Our primary goal was thus to determine the extent to which dexmedetomidine reduces the requirement for propofol and remifentanil .
METHODS	This double-blinded , randomized study ( NCT00921284 ) used an automated dual closed-loop administration to maintain the Bispectral Index between 40 and 60 .
METHODS	Sixty-6 ASA physical status I and II patients were given either dexmedetomidine ( 1 g/kg over 10 minutes followed by a continuous infusion of 0.5 g/kg/h throughout surgery ) or comparable volumes of saline as a placebo .
METHODS	Propofol and remifentanil requirements were compared using nonparametric tests and expressed as medians ( interquartile ranges ) .
RESULTS	Twenty-eight patients in each group completed the study .
RESULTS	Patients given dexmedetomidine required less propofol ( 1.0 [ 0.7-1 .3 ] vs 1.3 [ 1.0-1 .7 ] mg/kg , P = 0.002 ) and remifentanil ( 1.2 [ 1.0-1 .4 ] vs 1.6 [ 1.1-2 .8 ] g/kg , P = 0.02 ) for anesthetic induction .
RESULTS	The propofol dosage required for anesthetic maintenance was 29 % ( with a 95 % confidence interval , 18-40 ) lower in patients given dexmedetomidine ( 2.2 [ 1.5-3 .0 ] vs 3.1 [ 2.4-4 .5 ] mg/kg/h , P = 0.005 ) , whereas the remifentanil dosage was not significantly different ( 0.16 [ 0.09-0 .17 ] vs 0.14 [ 0.13-0 .21 ] g/kg/h with P = 0.3 ) .
RESULTS	The incidence of adverse events , including hemodynamic instability and delayed recovery , was comparable with and without dexmedetomidine .
RESULTS	The first postoperative request for morphine analgesia was delayed in patients given dexmedetomidine ( median fourth hour vs first hour , P = 0.008 ) .
CONCLUSIONS	Dexmedetomidine administration significantly reduced the requirement for both propofol and remifentanil during anesthetic induction and reduced propofol use during maintenance of anesthesia .
CONCLUSIONS	Dexmedetomidine also delayed postoperative analgesic use .
CONCLUSIONS	Dexmedetomidine is a useful adjuvant that reduces anesthetic requirement and provides postoperative analgesia .

###21410418
BACKGROUND	Drug-dependent pregnant women with intimate partners who are also drug-dependent have been found to have compromised treatment outcomes .
BACKGROUND	Thus , developing a treatment to reduce a male partner 's drug use is the first step in a line of research with a distal goal of improving pregnant patient 's treatment outcomes .
OBJECTIVE	This study examined a novel intervention for engaging the male partner in drug treatment .
METHODS	Men targeted for intervention were non-treatment-seeking opioid users .
METHODS	Motivational enhancement therapy ( MET ) , an effective non-confrontational intervention approach for evoking behavioral change , was employed to encourage treatment participation .
METHODS	This six-session intervention was followed by a drug-abstinent contingency-based voucher incentive program .
METHODS	Moreover , to help maintain drug abstinence , male partners had rapid facilitation into either opioid detoxification with aftercare or methadone maintenance .
METHODS	Interwoven into treatment were both couple 's counseling and a men 's group educational program designed to strengthen the support provided by the men to their partners during pregnancy and post-delivery .
METHODS	Men ( n = 45 ) received either the novel intervention package called HOPE ( Helping Other Partners Excel ) or a control condition ( n = 17 ) that received weekly support and referrals for treatment .
RESULTS	Men in the HOPE condition , compared with the usual care condition , showed increased treatment retention , transient decreases in heroin use , increased involvement in recreational activities , less reliance on public assistance , and increased social support for their pregnant partners .
CONCLUSIONS	Results suggest that treatment of male partners is feasible and efficacious in the short term but modifications to the intervention are needed to sustain results .

###24902920
BACKGROUND	High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes , including coronary heart disease , stroke , decompensated heart failure , chronic kidney disease , and decline in cognitive function .
BACKGROUND	Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg .
BACKGROUND	Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease .
BACKGROUND	However , the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear , and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large , definitive clinical trial .
OBJECTIVE	To describe the design considerations of the Systolic Blood Pressure Intervention Trial ( SPRINT ) and the baseline characteristics of trial participants .
METHODS	The Systolic Blood Pressure Intervention Trial is a multicenter , randomized , controlled trial that compares two strategies for treating systolic blood pressure : one targets the standard target of < 140 mm Hg , and the other targets a more intensive target of < 120 mm Hg .
METHODS	Enrollment focused on volunteers of age 50 years ( no upper limit ) with an average baseline systolic blood pressure 130 mm Hg and evidence of cardiovascular disease , chronic kidney disease , 10-year Framingham cardiovascular disease risk score 15 % , or age 75 years .
METHODS	The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups : participants with chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min/1 .73 m ( 2 ) ) , participants with a history of cardiovascular disease , and participants 75 years of age or older .
METHODS	The primary outcome is first the occurrence of a myocardial infarction ( MI ) , acute coronary syndrome , stroke , heart failure , or cardiovascular disease death .
METHODS	Secondary outcomes include all-cause mortality , decline in kidney function or development of end-stage renal disease , incident dementia , decline in cognitive function , and small-vessel cerebral ischemic disease .
RESULTS	Between 8 November 2010 and 15 March 2013 , Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics , including 3331 women , 2648 with chronic kidney disease , 1877 with a history of cardiovascular disease , 3962 minorities , and 2636 75 years of age .
CONCLUSIONS	Although the overall recruitment target was met , the numbers recruited in the high-risk subgroups were lower than planned .
CONCLUSIONS	The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants , including those with prior cardiovascular disease , chronic kidney disease , and those aged 75 years .

###23217054
BACKGROUND	Women with cancer are significantly more likely to fall than women without cancer placing them at higher risk of fall-related fractures , other injuries and disability .
BACKGROUND	Currently , no evidence-based fall prevention strategies exist that specifically target female cancer survivors .
BACKGROUND	The purpose of the GET FIT ( Group Exercise Training for Functional Improvement after Treatment ) trial is to compare the efficacy of two distinct types of exercise , tai chi versus strength training , to prevent falls in women who have completed treatment for cancer .
BACKGROUND	The specific aims of this study are to : 1 ) Determine and compare the efficacy of both tai chi training and strength training to reduce falls in older female cancer survivors , 2 ) Determine the mechanism ( s ) by which tai chi and strength training each reduces falls and , 3 ) Determine whether or not the benefits of each intervention last after structured training stops .
METHODS	We will conduct a three-group , single-blind , parallel design , randomized controlled trial in women , aged 50-75 years old , who have completed chemotherapy for cancer comparing 1 ) tai chi 2 ) strength training and 3 ) a placebo control group of seated stretching exercise .
METHODS	Women will participate in supervised study programs twice per week for six months and will be followed for an additional six months after formal training stops .
METHODS	The primary outcome in this study is falls , which will be prospectively tracked by monthly self-report .
METHODS	Secondary outcomes are maximal leg strength measured by isokinetic dynamometry , postural stability measured by computerized dynamic posturography and physical function measured by the Physical Performance Battery , all measured at baseline , 3 , 6 and 12 months .
METHODS	The sample for this trial ( N = 429 , assuming 25 % attrition ) will provide adequate statistical power to detect at least a 47 % reduction in the fall rate over 1 year by being in either of the 2 exercise groups versus the control group .
CONCLUSIONS	The GET FIT trial will provide important new knowledge about preventing falls using accessible and implementable exercise interventions for women following chemotherapy for cancer .
CONCLUSIONS	ClinicalTrials.gov NCT01635413 .

###15699482
OBJECTIVE	Liposomal lurtotecan ( OSI-211 ) is a liposomal formulation of the water-soluble topoisomerase I inhibitor lurtotecan ( GI147211 ) , which demonstrated superior levels of activity compared with topotecan in preclinical models .
OBJECTIVE	We studied two schedules of OSI-211 in a randomized design in relapsed ovarian cancer to identify the more promising of the two schedules for further study .
METHODS	Eligible patients had measurable epithelial ovarian , fallopian , or primary peritoneal cancer that was recurrent after one or two prior regimens of chemotherapy .
METHODS	Patients were randomly assigned to receive either arm A ( OSI-211 1.8 mg/m ( 2 ) / d administered by 30-minute intravenous infusion on days 1 , 2 , and 3 every 3 weeks ) or arm B ( OSI-211 2.4 mg/m ( 2 ) / d administered by 30-minute intravenous infusion on days 1 and 8 every 3 weeks ) .
METHODS	The primary outcome measure was objective response , which was confirmed by independent radiologic review , and a pick the winner statistical design was used to identify the schedule most likely to be superior .
RESULTS	Eighty-one patients were randomized between October 2000 and September 2001 .
RESULTS	The hematologic toxic effects were greater on arm A than on arm B ( grade 4 neutropenia , 51 % v 22 % , respectively ) , as was febrile neutropenia ( 26 % v 2.4 % , respectively ) .
RESULTS	Of the 80 eligible patients , eight patients ( 10 % ) had objective responses ; six responders ( 15.4 % ; 95 % CI , 6 % to 30 % ) were in arm A and two responders ( 4.9 % ; 95 % CI , 1 % to 17 % ) were in arm B.
CONCLUSIONS	The OSI-211 daily for 3 days intravenous schedule met the statistical criteria to be declared the winner in terms of objective response .
CONCLUSIONS	This schedule was also associated with more myelosuppression than the schedule of OSI-211 administered in arm B.

###21072756
OBJECTIVE	To compare the postoperative complication rates of phosphorylcholine-coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes .
METHODS	A prospective randomized double-blind controlled trial in children with recurrent acute otitis media and chronic otitis media with effusion ; 240 children were randomized to receive a phosphorylcholine-coated tube in one ear and an uncoated tube in the other .
METHODS	Postoperatively , patients were assessed at 2 weeks and 4 , 8 , 12 , 18 , and 24 months to ascertain the incidence of otorrhea , tube lumen blockage , and early extrusion .
RESULTS	Out of 240 children , 5 withdrew and 16 were lost to early follow-up .
RESULTS	The mean age was 43.8 months .
RESULTS	There were no statistically significant differences in the incidence of postoperative otorrhea , tube blockage , and extrusion .
CONCLUSIONS	Phosphorylcholine-coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes .

###23398140
OBJECTIVE	The aims of this study were to determine the effects of synbiotic ( probiotic plus prebiotic ) supplementation on total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) levels of human breastmilk .
METHODS	In this randomized , double-blind , placebo-controlled trial , 80 lactating mothers were randomly divided into two groups to receive a daily supplement of synbiotic ( n = 40 ) or a placebo ( n = 40 ) for 30 days .
METHODS	Information on dietary intake was collected from lactating women using the 24-hour recall method for 3 days before and after supplementation .
METHODS	The TAC was measured by using a Randox ( Crumlin , County Antrim , United Kingdom ) assay , and the MDA level of breastmilk as thiobarbitaric acid complexes was measured by the fluorometry method .
METHODS	Data analysis was carried out using Nutritionist IV ( Axxya Systems , Stafford , TX ) and SPSS ( SPSS , Inc. , Chicago , IL ) .
RESULTS	The TAC of breastmilk increased significantly from 0.3120.16 to 0.4810.2 mmol/L in the supplemented group ( p < 0.039 ) , whereas it decreased from 0.3170.18 to 0.2550.13 mmol/L in the placebo group ( p > 0.13 ) .
RESULTS	Although the MDA level decreased slightly from 1.620.69 to 1.60.95 mol/L in the supplemented group , it increased significantly in the placebo group from 1.710.86 to 2.160.277 mol/L after the experimental period ( p < 0.001 ) .
RESULTS	Also , maternal vitamin A , E , and C , zinc , and selenium intake did not change significantly in both groups during the study period .
RESULTS	Moreover , no significant correlation was found between weight for age Z-score of infants and TAC and MDA levels in breastmilk .
CONCLUSIONS	Based on these results , synbiotic supplementation may have positive effects on the TAC and MDA levels in breastmilk ; however , these findings require confirmation from future trials .

###24047126
BACKGROUND	Antimuscarinic agents are currently the predominant treatment option for the clinical management of the symptoms of overactive bladder ( OAB ) .
BACKGROUND	However , low rates of persistence with these agents highlight the need for novel , effective and better-tolerated oral pharmacological agents .
BACKGROUND	Mirabegron is a 3-adrenoceptor agonist developed for the treatment of OAB , with a mechanism of action distinct from that of antimuscarinics .
BACKGROUND	In a randomized , double-blind , placebo - and active-controlled Phase 3 trial conducted in Europe and Australia ( NCT00689104 ) , mirabegron 50mg and 100mg resulted in statistically significant reductions from baseline to final visit , compared with placebo , in the co-primary end points - mean number of incontinence episodes/24h and mean number of micturitions/24h .
BACKGROUND	We conducted a post hoc , subgroup analysis of this study in order to evaluate the efficacy of mirabegron in treatment-nave patients and patients who had discontinued prior antimuscarinic therapy because of insufficient efficacy or poor tolerability .
METHODS	Patients were randomized to placebo , mirabegron 50 or 100mg , or tolterodine extended release ( ER ) 4mg orally , once-daily , for 12weeks .
METHODS	For the post hoc analysis , the primary patient population was divided into the following subgroups : ( 1 ) patients who had not received any prior antimuscarinic OAB medication ( treatment-nave ) and ( 2 ) patients who had received prior antimuscarinic OAB medication .
METHODS	The latter subgroup was further subdivided into patients who discontinued due to : ( 3 ) insufficient efficacy or ( 4 ) poor tolerability .
METHODS	Analysis of the co-primary efficacy endpoints by subgroup was performed using analysis of covariance with treatment group , subgroup , sex , geographical region , and subgroup-by-treatment interaction as fixed factors ; and baseline value as a covariate .
RESULTS	Mirabegron , 50mg and 100mg once-daily , demonstrated similar improvements in the frequency of incontinence episodes and micturitions in OAB patients who were antimuscarinic-nave and who had discontinued prior antimuscarinic therapy .
RESULTS	While mirabegron demonstrated improvements in incontinence and micturition frequency in patients who had discontinued prior antimuscarinic therapy due to insufficient efficacy , the response to tolterodine was similar to that of placebo .
CONCLUSIONS	In this post hoc subgroup analysis , mirabegron provided treatment benefits in OAB patients who were antimuscarinic treatment-nave and in patients who had received prior antimuscarinic treatment .

###8892717
OBJECTIVE	To evaluate the effect of catheter tunneling on internal jugular catheter-related sepsis in critically ill patients .
METHODS	A prospective randomized controlled study involving 3 intensive care units ( ICUs ) , stratified by number of catheter lumina ( 1 or 2 ) and center .
METHODS	The 10-bed medical-surgical and 10-bed surgical ICUs at Saint Joseph Hospital and 8-bed surgical ICU at Clinique de la Dfense , Paris , France .
METHODS	Every patient older than 18 years admitted to the ICUs between March 1 , 1993 , and July 17,1996 , who required a jugular venous catheter for more than 48 hours .
METHODS	Random allocation to tunneled or nontunneled catheters .
METHODS	Times to occurrence of systemic catheter-related sepsis , catheter-related septicemia , or a quantitative catheter-tip culture with a cutoff of 103 colony-forming units per milliliter .
RESULTS	A total of 241 patients were randomized .
RESULTS	Ten patients in whom jugular puncture was not achieved were subsequently excluded .
RESULTS	The proportion of patients receiving mechanical ventilation ( 87 % ) and mean + / - SD age ( 65 + / -4 years ) , Simplified Acute Physiologic Score ( 13.3 + / -4.9 ) , Organ System Failure score ( 1.5 + / -1.0 ) , and duration of catheterization ( 8.7 + / -5.0 days ) were similar in both groups .
RESULTS	Taking into account the first 231 catheters ( 114 nontunneled [ control ] , 117 tunneled ) , we found that tunnelization decreased catheter-related sepsis ( odds ratio [ OR ] , 0.33 ; 95 % confidence interval [ CI ] , 0.13-0 .83 ; P = .02 ) , catheter-related septicemia ( OR , 0.23 ; 95 % CI , 0.07-0 .81 ; P = .02 ) , and , though not statistically significant , positive quantitative tip-culture rate ( OR , 0.62 ; 95 % CI , 0.35-1 .10 ; P = .10 ) .
RESULTS	These results were slightly modified after adjustment on parameters either imbalanced between both groups ( duration of catheter placement and cancer at admission ) or prognostic ( insertion by a resident , use of antibiotics at catheter insertion , cancer , and sex ) .
CONCLUSIONS	The incidence of internal jugular catheter-related infections in critically ill patients can be reduced by using subcutaneous tunnelization .

###15213472
OBJECTIVE	To determine the effects of a perturbed walking exercise using a bilateral separated treadmill in physically disabled elderly .
METHODS	Participants of the study were 32 long-term care facility residents and outpatients aged 66-98 yrs .
METHODS	Participants were randomly assigned to a usual exercise group or to a treadmill exercise group .
METHODS	Perturbed gait exercise on a treadmill continued for 6 mos .
METHODS	Number of falls and time to first fall during a 6-mo period , balance and gait functions , and reaction time were evaluated before and after intervention .
RESULTS	The treadmill exercise group showed significant improvement in balance and reaction time when compared with the usual exercise group .
RESULTS	Number of falls in the treadmill exercise group was 21 % lower than that in the usual exercise group .
RESULTS	However , this difference was not significant .
RESULTS	No significant differences were seen in time to first fall .
CONCLUSIONS	Gait training with unexpected perturbation seems to have a beneficial impact on physical function in disabled elderly individuals .
CONCLUSIONS	The results suggest that this program may be used as an exercise intervention to reduce falls in institutional settings .

###25180722
BACKGROUND	ICU-acquired weakness ( ICU-AW ) has immediate and long-term consequences for critically ill patients .
BACKGROUND	Strategies for the prevention of weakness include modification of known risk factors , such as hyperglycemia and immobility .
BACKGROUND	Intensive insulin therapy ( IIT ) has been proposed to prevent critical illness polyneuropathy .
BACKGROUND	However , the effect of insulin and early mobilization on clinically apparent weakness is not well known .
METHODS	This is a secondary analysis of all patients with mechanical ventilation ( N = 104 ) previously enrolled in a randomized controlled trial of early occupational and physical therapy vs conventional therapy , which evaluated the end point of functional independence .
METHODS	Every patient had IIT and blinded muscle strength testing on hospital discharge to determine the incidence of clinically apparent weakness .
METHODS	The effects of insulin dose and early mobilization on the incidence of ICU-AW were assessed .
RESULTS	On logistic regression analyses , early mobilization and increasing insulin dose prevented the incidence of ICU-AW ( OR , 0.18 , P = .001 ; OR , 0.001 , P = .011 ; respectively ) independent of known risk factors for weakness .
RESULTS	Early mobilization also significantly reduced insulin requirements to achieve similar glycemic goals as compared with control patients ( 0.07 units/kg/d vs 0.2 units/kg/d , P < .001 ) .
CONCLUSIONS	The duel effect of early mobilization in reducing clinically relevant ICU-AW and promoting euglycemia suggests its potential usefulness as an alternative to IIT .

###15152874
BACKGROUND	Acute bacterial infections of the upper respiratory tract , including the nasal sinuses , lead to an activation of neutrophil granulocytes .
BACKGROUND	The protein myeloperoxidase ( MPO ) is released by this cell type only and therefore can act as a marker for activity of inflammation .
METHODS	In a prospective multicenter study , 45 patients with acute bacterial sinusitis ( diagnosed by clinical examination , ultrasonography , and X ray or computed tomography scan ) were treated with two different antibiotics ( Cefditoren or Cefuroxim twice a day for 10 days ) .
METHODS	Nasal secretions were collected with absorbing foam-rubber samplers and a concentration of MPO was evaluated before the therapy and after 7 + / - 1 days and 14 + / - 2 days of antibiotic treatment .
METHODS	The concentrations of MPO were measured by a radioimmunoassay method and the dilution factors were determined by the lithium method .
RESULTS	Significant differences in the MPO concentration in nasal secretions between the first and third visit could be found in both groups ( p < 0.01 each ) .
RESULTS	No significant difference was seen within the two different antibiotics used .
CONCLUSIONS	Measurement of MPO concentration in nasal secretions showed a significant change after antibiotic treatment of acute bacterial rhinosinusitis .
CONCLUSIONS	The reduction of MPO levels correlated with the observed clinical and radiological improvement of the disease .
CONCLUSIONS	Additional investigations are needed to achieve more knowledge about basal concentrations of MPO in healthy persons and different activation patterns before it can be determined whether the MPO measurement could be a suitable method for monitoring the success of an antibiotic treatment in acute bacterial sinusitis .

###25216649
BACKGROUND	Continuous theta burst stimulation ( cTBS ) of the human primary motor cortex ( M1 ) induces long-term depression ( LTD ) - like plastic changes in corticospinal excitability , but several studies have reported high inter-subject variability of this effect .
BACKGROUND	Most studies use a tonic voluntary contraction of the target muscle before cTBS to set stimulation intensity ; however , it is unclear how this might affect response variability .
OBJECTIVE	To examine the influence of pre-activation of the target hand muscle on inter-subject response variability to cTBS of the human M1 .
METHODS	The response to cTBS was assessed by changes in motor evoked potential ( MEP ) amplitude in the right first dorsal interosseous ( FDI ) muscle .
METHODS	For Study 1 , ten healthy subjects attended two sessions .
METHODS	They were instructed in one session to keep their FDI relaxed for the entire testing period ( pre-relax ) , and in the other to perform a 2-min 10 % of maximal voluntary tonic contraction 15 min before cTBS ( pre-active ) .
METHODS	For Study 2 , data from our previous study were re-analyzed to extend the pre-relax condition to an additional 26 subjects ( total n = 36 ) .
RESULTS	cTBS-induced highly consistent LTD-like MEP depression in the pre-relax condition , but not in the pre-active condition .
RESULTS	Inter-subject response variability increased in the pre-active condition .
CONCLUSIONS	cTBS induces consistent LTD-like plasticity with low inter-subject variability if pre-activation of the stimulated motor cortex is avoided .
CONCLUSIONS	This affirms a translational potential of cTBS in clinical applications that aim at reducing cortical excitability .

###21076285
OBJECTIVE	The aim of this study was to evaluate whether socioemotional stress affects the quality of cardiopulmonary resuscitation during advanced life support in a simulated manikin model .
METHODS	A randomized crossover trial with advanced life support performed in two different conditions , with and without exposure to socioemotional stress .
METHODS	The study was conducted at the Stavanger Acute Medicine Foundation for Education and Research simulation center , Stavanger , Norway .
METHODS	Paramedic teams , each consisting of two paramedics and one assistant , employed at Stavanger University Hospital , Stavanger , Norway .
METHODS	A total of 19 paramedic teams performed advanced life support twice in a randomized fashion , one control condition without socioemotional stress and one experimental condition with exposure to socioemotional stress .
METHODS	The socioemotional stress consisted of an upset friend of the simulated patient who was a physician , spoke a foreign language , was unfamiliar with current Norwegian resuscitation guidelines , supplied irrelevant clinical information , and repeatedly made doubts about the paramedics ' resuscitation efforts .
METHODS	Aural distractions were supplied by television and cell telephone .
RESULTS	The primary outcome was the quality of cardiopulmonary resuscitation : chest compression depth , chest compression rate , time without chest compressions ( no-flow ratio ) , and ventilation rate after endotracheal intubation .
RESULTS	As a secondary outcome , the socioemotional stress impact was evaluated through the paramedics ' subjective workload , frustration , and feeling of realism .
RESULTS	There were no significant differences in chest compression depth ( 39 vs. 38 mm , p = .214 ) , compression rate ( 113 vs. 116 min , p = .065 ) , no-flow ratio ( 0.15 vs. 0.15 , p = .618 ) , or ventilation rate ( 8.2 vs. 7.7 min , p = .120 ) between the two conditions .
RESULTS	There was a significant increase in the subjective workload , frustration , and feeling of realism when the paramedics were exposed to socioemotional stress .
CONCLUSIONS	In this advanced life support manikin study , the presence of socioemotional stress increased the subjective workload , frustration , and feeling of realism , without affecting the quality of cardiopulmonary resuscitation .

###25867783
BACKGROUND	Self-monitoring by mobile phone applications offers new opportunities to engage patients in self-management .
BACKGROUND	Self-monitoring has not been examined thoroughly as a self-directed intervention strategy for self-management of multiple behaviors and states by people living with HIV ( PLH ) .
METHODS	PLH ( n = 50 ) , primarily African American and Latino , were recruited from 2 AIDS services organizations and randomly assigned to daily smartphone ( n = 34 ) or biweekly Web-survey only ( n = 16 ) self-monitoring for 6 weeks .
METHODS	Smartphone self-monitoring included responding to brief surveys on medication adherence , mental health , substance use , and sexual risk behaviors , and brief text diaries on stressful events .
METHODS	Qualitative analyses examine biweekly open-ended user-experience interviews regarding perceived benefits and barriers of self-monitoring , and to elaborate a theoretical model for potential efficacy of self-monitoring to support self-management for multiple domains .
RESULTS	Self-monitoring functions include reflection for self-awareness , cues to action ( reminders ) , reinforcements from self-tracking , and their potential effects on risk perceptions , motivations , skills , and behavioral activation states .
RESULTS	Participants also reported therapeutic benefits related to self-expression for catharsis , nonjudgmental disclosure , and in-the-moment support .
RESULTS	About one-third of participants reported that surveys were too long , frequent , or tedious .
RESULTS	Some smartphone group participants suggested that daily self-monitoring was more beneficial than biweekly due to frequency and in-the-moment availability .
RESULTS	About twice as many daily self-monitoring group participants reported increased awareness and behavior change support from self-monitoring compared with biweekly Web-survey only participants .
CONCLUSIONS	Self-monitoring is a potentially efficacious disruptive innovation for supporting self-management by PLH and for complementing other interventions , but more research is needed to confirm efficacy , adoption , and sustainability .

###9843456
BACKGROUND	Although diabetes is a major risk factor for coronary heart disease ( CHD ) , little information is available on the effects of lipid lowering in diabetic patients .
BACKGROUND	We determined whether lipid-lowering treatment with pravastatin prevents recurrent cardiovascular events in diabetic patients with CHD and average cholesterol levels .
RESULTS	The Cholesterol And Recurrent Events ( CARE ) trial , a 5-year trial that compared the effect of pravastatin and placebo , included 586 patients ( 14.1 % ) with clinical diagnoses of diabetes .
RESULTS	The participants with diabetes were older , more obese , and more hypertensive .
RESULTS	The mean baseline lipid concentrations in the group with diabetes -- 136 mg/dL LDL cholesterol , 38 mg/dL HDL cholesterol , and 164 mg/dL triglycerides -- were similar to those in the nondiabetic group .
RESULTS	LDL cholesterol reduction by pravastatin was similar ( 27 % and 28 % ) in the diabetic and nondiabetic groups , respectively .
RESULTS	In the placebo group , the diabetic patients suffered more recurrent coronary events ( CHD death , nonfatal myocardial infarction [ MI ] , CABG , and PTCA ) than did the nondiabetic patients ( 37 % versus 25 % ) .
RESULTS	Pravastatin treatment reduced the absolute risk of coronary events for the diabetic and nondiabetic patients by 8.1 % and 5.2 % and the relative risk by 25 % ( P = 0.05 ) and 23 % ( P < 0.001 ) , respectively .
RESULTS	Pravastatin reduced the relative risk for revascularization procedures by 32 % ( P = 0.04 ) in the diabetic patients .
RESULTS	In the 3553 patients who were not diagnosed as diabetic , 342 had impaired fasting glucose at entry defined by the American Diabetes Association as 110 to 125 mg/dL .
RESULTS	These nondiabetic patients with impaired fasting glucose had a higher rate of recurrent coronary events than those with normal fasting glucose ( eg , 13 % versus 10 % for nonfatal MI ) .
RESULTS	Recurrence rates tended to be lower in the pravastatin compared with placebo group ( eg , -50 % , P = 0.05 for nonfatal MI ) .
CONCLUSIONS	Diabetic patients and nondiabetic patients with impaired fasting glucose are at high risk of recurrent coronary events that can be substantially reduced by pravastatin treatment .

###22607870
BACKGROUND	The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions ( PCIs ) is uncertain .
BACKGROUND	We aimed to assess the impact of glycoprotein IIb/IIIa ( GpIIb/IIIa ) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions .
METHODS	Patients with stable coronary artery disease undergoing PCI by means of implantation of > 33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone .
METHODS	The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values .
METHODS	Secondary end points were major adverse cardiovascular events ( MACEs ) ( ie , cardiac death , myocardial infarction , or urgent revascularization ) and MACE plus bailout GpIIb/IIIa inhibitor use .
RESULTS	The study was stopped for slow enrollment and funding issues after including a total of 91 patients : 44 were randomized to heparin plus eptifibatide , and 47 , to heparin alone .
RESULTS	Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group ( 18 [ 41 % ] ) versus the heparin-alone group ( 26 [ 55 % ] , relative risk 0.74 [ 95 % CI 0.48-1 .15 ] , P = .169 ) .
RESULTS	Similar nonstatistically significant trends were found for rates of MACE , their components , or MACE plus bailout GpIIb/IIIa inhibitors ( all P > .05 ) .
RESULTS	Notably , heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups ( all P > .05 ) .
CONCLUSIONS	Given its lack of statistical power , the INSTANT study can not definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease .
CONCLUSIONS	However , the favorable trend evident for the primary end point warrants further larger randomized studies .

###20433277
OBJECTIVE	The Onyx liquid embolic system ( Onyx ) was approved in the European Union in 1999 for embolization of lesions in the intracranial and peripheral vasculature , including brain arteriovenous malformations ( AVMs ) and hypervascular tumors .
OBJECTIVE	In 2001 a prospective , equivalence , multicenter , randomized controlled trial was initiated to support a submission for FDA approval .
OBJECTIVE	The objective of this study was to verify the safety and efficacy of Onyx compared with N-butyl cyanoacrylate ( NBCA ) for the presurgical treatment of brain AVMs .
METHODS	One hundred seventeen patients with brain AVMs were treated with either Onyx ( 54 patients ) or NBCA ( 63 patients ) for presurgical endovascular embolization between May 2001 and April 2003 .
METHODS	The primary end point was technical success in achieving 50 % reduction in AVM volume .
METHODS	Secondary end points were operative blood loss and resection time .
METHODS	All adverse events ( AEs ) were reported and assigned a relationship to the Onyx or NBCA system , treatment , disease , surgery , or other/unknown .
METHODS	The Data Safety Monitoring Board adjudicated AEs , and a blinded , independent core lab assessed volume measurements .
METHODS	Patients were monitored through discharge after the final surgery or through a 3 - and/or 12-month follow-up if resection had not been performed or was incomplete .
RESULTS	The use of Onyx led to 50 % AVM volume reduction in 96 % of cases versus 85 % for NBCA ( p = not significant ) .
RESULTS	The secondary end points of resection time and blood loss were similar .
RESULTS	Serious AEs were also similar between the 2 treatment groups .
CONCLUSIONS	Onyx is equivalent to NBCA in safety and efficacy as a preoperative embolic agent in reducing brain AVM volume by at least 50 % .

###20806388
OBJECTIVE	We present our clinical experiences of two recently introduced vaporization laser systems : the GreenLight High Performance System ( HPS ) laser ( 532 nm , 120 W ) and the Diolas LFD diode laser ( 980 nm , 200 W ) .
METHODS	Two laser systems were evaluated to compare their clinical results for the treatment of benign prostatic hyperplasia ( BPH ) .
METHODS	Patients were treated using either the GreenLight HPS laser ( n = 84 ) or the diode laser ( n = 55 ) in a prospective randomized study .
METHODS	The data of International Prostate Symptom Score ( IPSS ) , maximum flow rate ( Q ( max ) ) , post-void residual urine ( PVR ) , and quality of life score ( Qols ) were recorded at baseline , 1 - , 6 - , and 12-month follow-ups .
METHODS	The prostate volume and prostate-specific antigen ( PSA ) level were assessed at baseline and 6-month follow-up .
METHODS	All complications were also recorded .
RESULTS	There was a statistically significant difference in IPSS , Q ( max ) , PVR , and QoLs in each laser group at the 1 - , 6 - , and 12-month follow-ups compared with baseline .
RESULTS	There was no statistical significant difference in any of these parameters at any follow-up interval between each group .
RESULTS	The diode laser demonstrates superior hemostatic properties compared with the GreenLight HPS laser .
RESULTS	Postoperative incontinence and postoperative irritative symptoms are more pronounced ( P < 0.05 ) after diode laser prostatectomy .
RESULTS	Higher incidence of dysuria with sloughing tissues and epididymitis ( P < 0.05 ) is noted after diode laser prostatectomy .
RESULTS	Other complications were comparable for both procedures .
CONCLUSIONS	Although both lasers can improve subjective and objective parameters of BPH , both can produce undesired effects .
CONCLUSIONS	The search for the ideal vaporization laser to treat BPH still continues .

###8792695
OBJECTIVE	To evaluate complete symptom resolution , mucosal healing , and tolerability of omeprazole , ranitidine , or ranitidine/metoclopramide in patients with poorly responsive , symptomatic gastroesophageal reflux disease ( GERD ) .
METHODS	Adults with persistent symptomatic GERD after ranitidine treatment were stratified by esophagitis grade and randomized to omeprazole 20 mg once daily , ranitidine HCI 150 mg twice daily , or ranitidine HCI 150 mg twice daily plus metoclopramide HCI 10 mg four times daily .
METHODS	Endoscopies were conducted at baseline and at wk 4 and 8 .
METHODS	Patients assessed overall symptom improvement at wk 4 and 8 and evaluated daytime and nighttime heartburn , dysphagia , and acid regurgitation daily .
RESULTS	After 1 wk , 13 % of patients receiving omeprazole ( N = 100 ) had complete resolution of all GERD symptoms versus 1 % and 3 % of patients receiving ranitidine ( N = 97 ) or ranitidine/metoclopramide ( N = 93 ) , respectively ( p < 0.001 ) .
RESULTS	More patients receiving omeprazole had complete symptom resolution at wk 4 ( 33 % ) and at the end of the study ( 64 % ; both p < 0.001 ) than patients receiving ranitidine ( 8 % and 28 % , respectively ) or ranitidine/metoclopramide ( 7 % and 29 % , respectively ) .
RESULTS	Regardless of baseline esophagitis grade , more patients receiving omeprazole had complete symptom resolution .
RESULTS	At wk 8 , more than 91 % of patients with grade 0 or 1 esophagitis at baseline were still healed irrespective of treatment .
RESULTS	At wk 8 , 80 % of patients with esophagitis grade 2 or higher at entry were healed with omeprazole ( p < 0.001 vs ranitidine [ 40 % ] and ranitidine/metoclopramide [ 46 % ] ) .
RESULTS	Thirty-four percent of patients reported an adverse event .
RESULTS	Significantly more patients receiving combination treatment reported an adverse event than patients treated with single agents .
CONCLUSIONS	In patients with persistent GERD symptoms after ranitidine , omeprazole ( 20 mg daily for up to 8 wk ) provides faster and more complete resolution of common GERD symptoms than continued ranitidine ( 300 mg daily ) alone or in combination with metoclopramide ( 40 mg daily ) .
CONCLUSIONS	Omeprazole provides significantly higher rates of endoscopic healing than ranitidine alone or with metoclopramide .
CONCLUSIONS	Omeprazole and ranitidine are generally well tolerated .
CONCLUSIONS	The addition of metoclopramide to ranitidine significantly increases adverse events .

###16331115
OBJECTIVE	To evaluate the efficacy of a programme of home blood pressure measurement ( HBPM ) on therapeutic compliance in mild-to-moderate hypertension .
METHODS	A prospective controlled multicentre clinical trial .
METHODS	Forty primary care centres in Spain , with a duration of 6 months .
METHODS	A total of 250 patients with newly diagnosed or uncontrolled hypertension were included .
METHODS	The patients were randomly selected and distributed in two groups : ( 1 ) the control group ( CG ) who received standard health intervention ; ( 2 ) the intervention group ( IG ) : the patients in this group received an OMRON in their homes for a programme of HBPM .
METHODS	Four visits were scheduled , for the measurement of blood pressure ( BP ) .
METHODS	They were provided with an electronic monitor for measuring compliance ( monitoring events medication system ; MEMS ) .
METHODS	Therapeutic compliance was defined as a drug consumption of 80-110 % .
METHODS	A number of variables were calculated using the MEMS .
METHODS	The mean BP were calculated and the percentage of controlled patients .
RESULTS	A total of 200 patients completed the study ( 100 in each group ) .
RESULTS	Compliance was observed in 74 and 92 % , respectively , in the CG and IG [ 95 % confidence interval ( CI ) 63.9-84 .1 and 86.7-97 .3 ; P = 0.0001 ] , the mean percentage compliances were 87.6 and 93.5 % ( 95 % CI 81.2-94 and 80.7-98 .3 ; P = 0.0001 ) , the percentages of correct days were 83.6 and 89.4 % , the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06 % , and the levels of therapeutic cover were 86.7 and 93.1 % .
RESULTS	The number needed to treat to avoid one case of non-compliance was 5.6 patients .
RESULTS	The differences in the mean decreases in BP were significant for diastolic BP , with a greater decrease observed in the IG .
CONCLUSIONS	An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension , measured using the MEMS .

###8589875
BACKGROUND	Although myriad factors influence the defibrillation threshold , the relation between the site of transvenous lead entry into the vascular system and the defibrillation threshold has not been reported .
BACKGROUND	This study examines the influence that venous entry site has on defibrillation success for a transvenous implantable cardioverter defibrillator lead with two defibrillating coils .
RESULTS	The study population comprised 345 patients .
RESULTS	Their mean age was 61 + / - 13 years and , left ventricular ejection fraction was 0.33 + / - 0.13 .
RESULTS	A left-sided approach was used in 324 ( 93.9 % ) of the patients , and a right-sided approach was used in the remaining 21 ( 6.1 % ) patients .
RESULTS	There was no difference in the gender , age , left ventricular ejection fraction , or underlying cardiac disease in the two groups .
RESULTS	For all patients , with a transvenous lead used either alone or with a submuscular or subcutaneous patch , the biphasic defibrillation threshold was 9.9 + / - 4.8 J when a left-sided approach was used , and 14.0 + / - 7.3 J when a right-sided approach was used ( P = 0.02 ) .
RESULTS	When a transvenous lead was used with a submuscular or subcutaneous patch ( 115 patients ) , the biphasic defibrillation threshold was 9.5 + / - 4.3 J when a left-sided approach was used , and 12.0 + / - 10.0 J when a right-sided approach was used ( P = 0.98 ) .
RESULTS	When a transvenous lead was used without a submuscular or subcutaneous patch ( 230 patients ) , the biphasic defibrillation threshold was 10.1 + / - 5.0 J when a left-sided approach was used , and 14.6 + / - 6.6 J when a right-sided approach was used ( P < 0.01 ) .
RESULTS	For the entire group of patients and for each specific lead arrangement , there was no significant difference in the defibrillating lead system impedance when right-sided versus left-sided approaches were compared .
CONCLUSIONS	Left-sided approaches to implant transvenous leads with two coils for defibrillation result in lower biphasic defibrillation thresholds than when right-sided approaches are used .

###24139765
BACKGROUND	Treatment for tobacco dependence is not available in many low-resource settings , especially in developing countries .
OBJECTIVE	To test the impact of a novel mix of monetary and social incentives on smoking abstinence in rural communities of Thailand .
METHODS	An RCT of commitment contracts and team incentives for rural smokers to quit smoking .
METHODS	Smokers were not blinded to treatment status , although the assessor of the biochemical urine test was .
METHODS	All adult smokers living in the study area were eligible to participate ; 215 adult smokers from 42 villages in Nakhon Nayok province , Thailand , participated .
METHODS	Fourteen smokers who lacked teammates were dropped .
METHODS	A total of 201 smokers were assigned to a two-person team , and then randomly assigned by team ( in a 2:1 ratio ) with computer-generated random numbers to receive smoking-cessation counseling ( control group ) or counseling plus offer of a commitment contract , team incentives , and text message reminders for smoking cessation at 3 months ( intervention group ) .
METHODS	The primary outcome was biochemically verified 7-day abstinence at 6 months , assessed on an intention-to-treat basis .
METHODS	Secondary outcomes include study participation , biochemically verified abstinence at 3 months , self-reported abstinence at 14 months , and the incremental cost per quitter of the intervention , nicotine gum , and varenicline in Thailand .
METHODS	Data were collected in 2010-2011 and analyzed in 2012 .
RESULTS	The trial enrolled 215 ( 10.5 % ) of 2055 smokers .
RESULTS	The abstinence rate was 46.2 % ( 61/132 ) in the intervention group and 14.5 % ( 10/69 ) in the control group ( adjusted OR 7.5 [ 3.0-18 .6 ] ) at 3 months ; 44.3 % ( 58/131 ) and 18.8 % ( 13/69 ) at the primary end point of 6 months ( adjusted OR 4.2 [ 1.8-9 .7 ] ) ; and 42.0 % ( 55/131 ) and 24.6 % ( 17/69 ) at 14 months ( adjusted OR 2.2 [ 1.0-4 .8 ] ) .
RESULTS	The purchasing power parity-adjusted incremental cost per quitter from the intervention is $ 281 ( 95 % CI = $ 187 , $ 562 ) , less than for nicotine gum ( $ 1780 , 95 % CI = $ 1414 , $ 2401 ) or varenicline ( $ 2073 , 95 % CI = $ 1357 , $ 4388 ) in Thailand .
CONCLUSIONS	The intervention enhanced abstinence by 91 % -136 % at 6 months , relative to the control group , although self-reports at 14 months suggest tapering of the treatment effect .
CONCLUSIONS	The intervention may offer a viable , cost-effective alternative to current smoking-cessation approaches in low-resource settings .
BACKGROUND	This study is registered at ClinicalTrials.gov NCT01311115 .

###22489439
BACKGROUND	Nearly all persons ( 37 % of public ) who have a joined an organ donor registry in the United States have done so through their Department of Motor Vehicles ( DMV ) office , which is an underused venue for organ donation campaigns .
OBJECTIVE	To evaluate the effectiveness of a statewide DMV-based intervention to increase donor designation rates .
METHODS	Thirty DMV offices in Florida were randomly assigned to receive usual care ( n = 15 ) or an organ donation intervention ( n = 15 ) .
METHODS	MEASUREMENT AND PRIMARY OUTCOME : Donor designation rates were assessed at baseline ( before the intervention ) , during the intervention , and at follow-up .
RESULTS	When baseline donor designation rate and region were controlled for , the intervention group showed a significantly higher aggregate monthly donor designation rate than the usual care group during the intervention phase of the study ( P = .02 ) .
RESULTS	Donor designation rates did not differ significantly ( P = .13 ) during the follow-up phase .
RESULTS	Lower donor designations rates were significantly associated with DMV service regions with more minorities , less education , and lower income .
CONCLUSIONS	We conclude that a comprehensive DMV-based intervention focused on staff education and direct interactions with the public could yield modest increases in donor designation rates .

###15572812
OBJECTIVE	To compare the clinical efficacy and side effects of terbutaline and salbutamol administered by metered dose inhaler and holding chamber in the mild to moderate acute exacerbations of asthma in children .
METHODS	The study subjects were children in the age group of 5 - 15 years who presented with a mild or moderate acute exacerbation of asthma .
METHODS	Baseline assessment included clinical parameters and spirometry .
METHODS	The children were then randomized to receive salbutamol or terbutaline .
METHODS	Three puffs each of either 100 mcg salbutamol or 250 mcg of terbutaline were administered using 750 ml holding chamber with valve .
METHODS	Thirty minutes after drug administration , the children were reevaluated for clinical parameters and spirometry .
RESULTS	Of the total 60 subjects studied , 31 were administered terbutaline and 29 salbutamol .
RESULTS	The baseline spirometric parameters were comparable .
RESULTS	After drug administration , all the studied variables showed significant improvement within each group .
RESULTS	However , there were no statistically significant differences when the two groups were compared with each other .
RESULTS	There was no significant difference in the side effects between two groups .
CONCLUSIONS	Terbutaline and salbutamol , when administered by MDI with holding chamber , are equally efficacious in children with mild or moderate acute exacerbation of asthma .

###22587593
OBJECTIVE	The balance between T helper cell subsets is an important regulator of the immune system and is often examined after immune therapies .
OBJECTIVE	We aimed to study the immunomodulatory effect of glutamic acid decarboxylase ( GAD ) 65 formulated with aluminium hydroxide ( GAD-alum ) in children with Type 1 diabetes , focusing on chemokines and their receptors .
METHODS	Blood samples were collected from 70 children with Type 1 diabetes included in a phase II clinical trial with GAD-alum .
METHODS	Expression of CC chemokine receptor 5 ( CCR5 ) and CCR4 was analysed on CD4 + and CD8 + lymphocytes after in vitro stimulation with GAD ( 65 ) using flow cytometry , and secretion of the chemokines CCL2 , CCL3 and CCL4 was detected in peripheral blood mononuclear cell supernatants with Luminex .
RESULTS	Expression of Th1-associated CCR5 was down-regulated following antigen challenge , together with an increased CCR4/CCR5 ratio and CCL2 secretion in GAD-alum-treated patients , but not in the placebo group .
CONCLUSIONS	Our results suggest that GAD-alum treatment has induced a favourable immune modulation associated with decreased Th1/Tc1 phenotypes upon antigen re-challenge , which may be of importance for regulating GAD ( 65 ) immunity .

###14650098
BACKGROUND	The lack of lactobacilli in the vagina of postmenopausal women due to estrogen deficiency plays an important role in the development of bacteriuria .
BACKGROUND	In the last few years the use of lactobacilli for the prevention of genitourinary infections has been explored using different probiotic strains .
OBJECTIVE	To evaluate the vaginal colonization by Lactobacillus rhamnosus GG in postmenopausal healthy women following oral administration of the bacteria in a yogurt base for 1 month , as a first step in evaluating the potential probiotic role of LGG in the prevention of recurrent urinary tract infections .
METHODS	One or two doses per day of yogurt containing 10 ( 9 ) colony-forming units of LGG were administered orally to 42 postmenopausal healthy women for 1 month .
METHODS	Vaginal and rectal swabs were cultured at the beginning and end of the study .
RESULTS	At the end of the study the vaginas of only four women ( 9.5 % ) were colonized with LGG , at a very low number of bacteria , despite the fact that the gastrointestinal tracts of 33 women ( 78.6 % ) were colonized .
RESULTS	There were no significant differences between one or two doses daily .
CONCLUSIONS	LGG should not be considered as a probiotic agent in urinary infections since it does not attach well to the vaginal epithelium .

###26349124
OBJECTIVE	To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes .
METHODS	This was a randomized , examiner-blind , parallel-group , two-treatment clinical trial of two weeks ' duration .
METHODS	Subjects qualified for the study if they had an average Modified Lobene Stain Index of 1.5 from two anterior teeth .
METHODS	At baseline , subjects brushed in front of a mirror for one minute under supervision .
METHODS	All subjects were provided with a standard 0.243 % sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush ( OBP ) or a Colgate Whitening manual brush ( CW ) to use for two weeks .
METHODS	Stain was reassessed after two weeks of product use .
METHODS	Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index , which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index .
RESULTS	Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use .
RESULTS	Median stain reductions were 78 % and 60 % for the OBP and CW , respectively , as measured by the Modified Lobene Stain Index .
RESULTS	The mean changes in the composite scores from baseline to week two were 1.85 and 1.57 for the two treatment groups , respectively .
RESULTS	Statistically significant reductions from baseline were also found for the intensity and extent of stain measures ( p < 0.001 ) .
RESULTS	Similar trends were found using the new Interproximal Modified Lobene Index .
RESULTS	Composite median stain removal percentages versus baseline were 88 % and 73 % for the OBP and CW groups , respectively ( p < 0.001 ) .
RESULTS	For the interproximal sites , a median stain removal of 92 % was observed with the OBP brush and 83 % reduction with the CW brush .
RESULTS	For the gingival sites , the median stain removal percentages were 83 % and 50 % , respectively For the body region , a median stain removal of 100 % was found for both treatment groups .
RESULTS	No statistically significant differences were found between the two groups for the mean composite scores for either index .
CONCLUSIONS	Both manual brushes showed effective stain removal , including interproximal hard-to-reach sites .
CONCLUSIONS	The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index , while allowing assessment of interproximal regions .

###8077904
BACKGROUND	Various types of anesthetic blocks have been used to prevent pain during ambulatory gynecologic surgery .
BACKGROUND	The purpose of this study was to compare the pain and cramping perceived by patients during the loop electrosurgical excision procedure when intramucosal or distal paracervical blocks were used .
METHODS	Seventy-seven women consented to participate in the prospective clinical trial .
METHODS	All women were premedicated with a nonsteroidal anti-inflammatory drug .
METHODS	Immediately after the procedure , a trained interviewer , blinded to the type of anesthetic block , recorded the patient 's perceptions of pain and cramping caused by the procedure .
METHODS	Age , parity , marital status , lesion severity , loop size used , number of specimens , amount of bleeding , method of hemostasis , and thermal artifact were included on the analysis .
RESULTS	On a Likert scale in which 0 = no pain/cramping and 10 = worst pain/cramping , the median pain score was 3 for the distal paracervical block and 4 for the intramucosal block .
RESULTS	The median cramping scores were 3 and 2 , respectively .
RESULTS	Pain and cramping scores did not differ significantly between the two block cohorts .
RESULTS	The demographic and procedural variables did not predict the perception of pain or cramping .
RESULTS	Most ( 89.6 % ) of the study population experienced pain , whereas fewer ( 64.9 % ) experienced cramping .
RESULTS	Subjects reported significantly less cramping than pain , irrespective of the anesthetic block used ( chi 2 = 13.35 , P = .0003 ) .
CONCLUSIONS	There is no difference in the perceptions of pain and cramping resulting from the loop electrosurgical excision procedure between patients receiving an intramucosal block and those receiving a distal paracervical block .
CONCLUSIONS	There is minimal pain and cramping associated with the procedure .

###20921118
BACKGROUND	Evidence-based treatment trials for adolescents with anorexia nervosa are few .
OBJECTIVE	To evaluate the relative efficacy of family-based treatment ( FBT ) and adolescent-focused individual therapy ( AFT ) for adolescents with anorexia nervosa in full remission .
METHODS	Randomized controlled trial .
METHODS	Stanford University and The University of Chicago ( April 2005 until March 2009 ) .
METHODS	One hundred twenty-one participants , aged 12 through 18 years , with DSM-IV diagnosis of anorexia nervosa excluding the amenorrhea requirement .
METHODS	Intervention Twenty-four outpatient hours of treatment over 12 months of FBT or AFT .
METHODS	Participants were assessed at baseline , end of treatment ( EOT ) , and 6 months ' and 12 months ' follow-up posttreatment .
METHODS	Full remission from anorexia nervosa defined as normal weight ( 95 % of expected for sex , age , and height ) and mean global Eating Disorder Examination score within 1 SD of published means .
METHODS	Secondary outcome measures included partial remission rates ( > 85 % of expected weight for height plus those who were in full remission ) and changes in body mass index percentile and eating-related psychopathology .
RESULTS	There were no differences in full remission between treatments at EOT .
RESULTS	However , at both the 6 - and 12-month follow-up , FBT was significantly superior to AFT on this measure .
RESULTS	Family-based treatment was significantly superior for partial remission at EOT but not at follow-up .
RESULTS	In addition , body mass index percentile at EOT was significantly superior for FBT , but this effect was not found at follow-up .
RESULTS	Participants in FBT also had greater changes in Eating Disorder Examination score at EOT than those in AFT , but there were no differences at follow-up .
CONCLUSIONS	Although both treatments led to considerable improvement and were similarly effective in producing full remission at EOT , FBT was more effective in facilitating full remission at both follow-up points .
BACKGROUND	clinicaltrials.gov Identifier : NCT00149786 .

###19734379
BACKGROUND	the multicentre , pragmatic , randomised controlled Acuflash study evaluated the effect of traditional Chinese medicine ( TCM ) acupuncture on postmenopausal vasomotor symptoms and health-related quality of life .
BACKGROUND	It concluded that use of acupuncture in addition to self-care can contribute to a clinically relevant reduction of hot flushes and increased health-related quality of life .
BACKGROUND	This article reports on the TCM syndrome diagnoses and acupuncture points used and their relation to the treatment response , and on treatment reactions and adverse events .
METHODS	the acupuncture group ( n = 134 ) received 10 acupuncture treatment sessions and advice on self-care ; the control group ( n = 133 ) received advice on self-care only .
METHODS	The study acupuncturists met the current membership criteria of the Norwegian Acupuncture Society , and had at least 3 years ' experience of practising TCM acupuncture .
METHODS	They were free to diagnose and select acupuncture points for each participant , after initial discussion .
RESULTS	fifty per cent of the participants in the acupuncture group were diagnosed with Kidney Yin Xu as their primary TCM syndrome diagnosis .
RESULTS	No statistically significant differences were demonstrated between the syndrome groups regarding the distribution of responders and non-responders , nor regarding the change in health-related quality of life scores .
RESULTS	A core of common acupuncture points ( SP6 , HT6 , KI7 , KI6 , CV4 , LU7 , LI4 , and LR3 ) were used in all the syndromes , and in addition multiple idiosyncratic points .
RESULTS	Core point selection and frequency of use did not differ between responders and non-responders .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment .

###7889438
OBJECTIVE	To assess the temporal behaviour of plasma lipoprotein ( a ) [ Lp ( a ) ] -- a low density lipoprotein-like particle whose plasma levels are associated with atherosclerosis risk -- and apolipoproteins ( apo ) B and A-I ( the major protein components of low and high density lipoproteins , respectively ) in acute myocardial infarction ( AMI ) , and to determined the effect of tissue plasminogen activator ( tPA ) on them .
METHODS	Serial Lp ( a ) , apoB and apoA-I determinations were obtained over eight days in 19 AMI patients who were part of a randomized , placebo ( n = 7 ) controlled trial of tPA ( n = 12 ) .
RESULTS	At 48 h postinfarct , plasma Lp ( a ) and apoB concentrations were , respectively , 20 % ( 24.9 + / - 3.0 to 19.9 + / - 2.9 mg/dL , P < 0.05 ) and 28 % ( 1.37 + / - 0.10 to 0.99 + / - 0.11 mM/L , P < 0.05 ) below baseline values .
RESULTS	ApoA-I concentrations were unchanged at 48 h postinfarct .
RESULTS	At 192 h postinfarct , Lp ( a ) rebounded to 36 % above baseline ( 24.9 + / - 3.0 to 33.9 + / - 3.9 mg/dL , P < 0.05 ) , apoB returned to baseline ( 1.37 + / - 0.10 versus 1.33 + / - 0.11 g/L , P < 0.05 ) and apoA-I was 15 % below baseline ( 1.43 + / - 0.06 to 1.21 + / - 0.06 g/L , not significant ) .
RESULTS	Administration of tPA had no effect on any of these changes .
CONCLUSIONS	Plasma Lp ( a ) and apolipoproteins undergo shifts from baseline values in the postinfarct period and tPA has no effect on these variations .

###25702095
BACKGROUND	Total knee arthroplasty ( TKA ) is associated with significant perioperative blood loss and need for transfusion .
BACKGROUND	This study aimed to evaluate the effectiveness and safety of tranexamic acid ( TXA ) to reduce perioperative blood loss in patients receiving TKA .
METHODS	A total of 92 patients who accepted unilateral TKA from May 2012 to May 2013 randomly received either 15 mg/kg TXA in 100 mL normal saline solution ( TXA group , n = 46 ) or the same amount of normal saline solution ( placebo group , n = 46 ) at 15 min before the tourniquet was loosened .
METHODS	The following data were recorded : intraoperative blood loss ; post-operative drainage at 12 h ; total drainage amount ; hidden blood loss ; total blood loss ; transfusion volumes ; number of transfusions ; post-operative hemoglobin at 1 , 3 , and 5 days ; D-dimer ; number of lower limb ecchymoses ; and deep vein thrombosis ( DVT ) .
RESULTS	A total of 81 patients were available for analysis ( TXA group , n = 41 ; placebo group , n = 40 ) .
RESULTS	Post-operative12-h drainage , post-operative 24-h D-dimer values , total drainage volume , hidden blood loss , total blood loss , and the rate of postoperative ecchymosis were lower in the TXA group than in the placebo group ( p < 0.05 ) .
RESULTS	The post-operative 3-day Hgb was higher in the TXA group than in the placebo group ( p = 0.000 ) .
RESULTS	The rate of transfusion and DVT was similar in both groups ( n.s. ) .
CONCLUSIONS	Perioperative blood loss could be reduced after TKA by intravenously injecting 15 mg/kg TXA at 15 min before the tourniquet was loosened .
CONCLUSIONS	The application of TXA is not associated with increased risk of DVT .

###12767566
OBJECTIVE	To observe the effect of the antioxidant lycopene on the occurrence of pre-eclampsia and intrauterine growth retardation in primigravida women .
METHODS	A total of 251 primigravida women were enrolled in this prospective , randomized controlled study in the second trimester .
METHODS	A total of 116 women were given oral lycopene ( Group I ) in a dose of 2 mg twice daily while 135 women were given a placebo ( Group II ) in the same dose until delivery .
METHODS	The criteria for recruitment included gestational age of 16-20 weeks , singleton pregnancy , absence of any medical complication and willingness on the part of the women to participate in the study .
METHODS	The women were followed-up until delivery for development of pre-eclampsia , mode of delivery and fetal outcome .
RESULTS	The two groups were comparable in their maternal characteristics .
RESULTS	Pre-eclampsia developed in significantly less women in the lycopene group than in the placebo group ( 8.6 % vs. 17.7 % , P = 0.043 by chi-square test ) .
RESULTS	Mean diastolic blood pressure was significantly higher in the placebo group ( 92.2 + / -5.98 mmHg vs. 86.7 + / -3.80 mmHg , P = 0.012 ) .
RESULTS	Mean fetal weight was significantly higher in the lycopene group ( 2751.17 + / -315.76 g vs. 2657 + / -444.30 g , P = 0.049 ) .
RESULTS	The incidence of intrauterine growth retardation was significantly lower in the lycopene group than in the placebo group ( 12 % vs. 23.7 % , P = 0.033 ) .
CONCLUSIONS	The results of the present study suggest that the antioxidant lycopene reduces the development of pre-eclampsia and intrauterine growth retardation in primigravida women .

###9393299
OBJECTIVE	To evaluate tumour progression and survival of patients with T1G3 bladder tumours who were followed for 15 years .
METHODS	A subset of 48 patients with T1G3 bladder tumours was entered into a randomized trial of transurethral resection ( TUR ) or TUR plus bacille Calmette-Gurin ( BCG ) therapy and followed for a minimum of 15 years .
METHODS	Thirty-nine ( 81 % ) patients received one or more courses of BCG .
METHODS	The endpoints of the study were stage progression ( defined as muscle invasion of metastasis ) and disease-specific survival .
RESULTS	Of the 48 patients , 25 ( 52 % ) progressed and 15 ( 31 % ) died from the disease ; 33 patients ( 69 % ) survived , including 24 ( 50 % ) with an intact bladder .
RESULTS	The median progression-free survival time was 151 months .
RESULTS	Tumour progression occurred in 35 % of the patients within the first 5 years , in 16 % after 5-10 years and in 12 % of those followed for 10-15 years .
RESULTS	Deaths from cancer occurred in 25 % of the patients in the first 5 years and in 10 % of patients at risk from 5 to 15 years .
CONCLUSIONS	Patients with T1G3 bladder tumours who are treated conservatively are at life-long risk of having a muscle-invasive tumour and dying from bladder cancer .

###22750085
OBJECTIVE	Besides its use in epilepsy , lamotrigine ( LTG ) is also effective as mood stabilizer .
OBJECTIVE	The pathophysiology of mood disorders may incorporate a dysfunction of neuronal plasticity and animal experiments suggest that mood stabilizers influence induction of long-term potentiation ( LTP ) and - depression ( LTD ) , two major forms of synaptic plasticity .
OBJECTIVE	However , the exact modes of action of LTG and its impact on neuronal plasticity in humans remain unclear .
METHODS	Here , we tested the effects of a single oral dose of LTG ( 300 mg ) on motor cortical plasticity induced by paired associative stimulation ( PAS ( 25 ) ) , a protocol that typically induces LTP-like plasticity , in 26 young healthy adults in a placebo-controlled , randomized , double-blind crossover design .
METHODS	We stratified analysis of the LTG effects according to the individual PAS ( 25 ) response in the placebo session ( 14 LTP-responders vs. 12 LTD-responders ) .
METHODS	Plasticity was indexed by motor evoked potential ( MEP ) amplitudes recorded before and for 60 min after PAS ( 25 ) .
RESULTS	LTG resulted in a significant reduction of the LTP-like MEP increase in the LTP-responders and a reduction of the LTD-like MEP decrease in the LTD-responders , with the majority of LTD-responders even showing an MEP increase .
CONCLUSIONS	In summary , LTG differentially modulated cortical plasticity induced by non-invasive brain stimulation in human subjects depending on their individual intrinsic propensity for expressing LTP-like or LTD-like plasticity .
CONCLUSIONS	Findings contribute to our understanding of the anticonvulsant and antidepressant clinical effects of LTG , which have been suggested to occur , at least in part , through downregulation of LTP ( epilepsy ) and LTD ( depressive disorders ) .

###11128543
OBJECTIVE	To evaluate clinical safety of administration of injectable enrofloxacin .
METHODS	Randomized controlled clinical trial .
METHODS	24 adult horses .
METHODS	Healthy horses were randomly allocated into 4 equal groups that received placebo injections ( control ) or IV administration of enrofloxacin ( 5 mg/kg [ 2.3 mg/lb ] , 15 mg/kg [ 6.8 mg/lb ] , or 25 mg/kg [ 11.4 mg/lb ] of body weight , q 24 h ) for 21 days .
METHODS	Joint angles , cross-sectional area of superficial and deep digital flexor and calcaneal tendons , carpal or tarsal osteophytes or lucency , and midcarpal and tarsocrural articular cartilage lesions were measured .
METHODS	Physical and lameness examinations were performed daily .
METHODS	Measurements were repeated after day 21 , and articular cartilage and bone biopsy specimens were examined .
RESULTS	Enrofloxacin did not induce changes in most variables during administration or for 7 days after administration .
RESULTS	One horse ( dosage , 15 mg/kg ) developed lameness and cellulitis around the tarsal plantar ligament during the last week of administration .
RESULTS	One horse ( dosage , 15 mg/kg ) developed mild superficial digital flexor tendinitis , and 1 horse ( dosage , 25 mg/kg ) developed tarsal sheath effusion without lameness 3 days after the last administration .
RESULTS	High doses of enrofloxacin ( 15 and 25 mg/kg ) administered by bolus injection intermittently induced transient neurologic signs that completely resolved within 10 minutes without long-term effects .
RESULTS	Slower injection and dilution of the dose ameliorated the neurologic signs .
RESULTS	Adverse reactions were not detected with a 5 mg/kg dose administered IV as a bolus .
CONCLUSIONS	Enrofloxacin administered IV once daily at the rate of 5 mg/kg for 3 weeks is safe in adult horses .

###17108847
OBJECTIVE	During the past few years serious concern has been raised about the safety of combined estrogen/progestogen hormone therapy , in particular about its effects on the breast .
OBJECTIVE	Several observations suggest that androgens may counteract the proliferative effects of estrogen and progestogen in the mammary gland .
OBJECTIVE	Thus , we aimed to study the effects of testosterone addition on breast cell proliferation during postmenopausal estrogen/progestogen therapy .
METHODS	We conducted a 6-month prospective , randomized , double-blind , placebo-controlled study .
METHODS	A total of 99 postmenopausal women were given continuous combined estradiol 2 mg/norethisterone acetate 1 mg and were equally randomly assigned to receive additional treatment with either a testosterone patch releasing 300 microg/24 hours or a placebo patch .
METHODS	Breast cells were collected by fine needle aspiration biopsy at baseline and after 6 months , and the main outcome measure was the percentage of proliferating breast cells positively stained by the Ki-67 / MIB-1 antibody .
RESULTS	A total of 88 women , 47 receiving active treatment and 41 in the placebo group , completed the study .
RESULTS	In the placebo group there was a more than fivefold increase ( P < 0.001 ) in total breast cell proliferation from baseline ( median 1.1 % ) to 6 months ( median 6.2 % ) .
RESULTS	During testosterone addition , no significant increase was recorded ( 1.6 % vs 2.0 % ) .
RESULTS	The different effects of the two treatments were apparent in both epithelial and stromal cells .
CONCLUSIONS	Addition of testosterone may counteract breast cell proliferation as induced by estrogen/progestogen therapy in postmenopausal women .

###8706070
BACKGROUND	Hypertension can no longer be evaluated only with regard to the increase of blood pressure ; its clinical picture must comprise also metabolic changes with originate from insulin resistance .
RESULTS	The authors submit some incentives from a 13-year long therapeutic follow-up of hypertension in a group of 54 middle-aged men suffering from essential hypertension .
RESULTS	From a control group of 38 men they differed as regards blood pressure ( 174.2 + / - 13.2 / 112.9 + / - 7.0 mm Hg vs. 126.4 + / - 13.9 / 77.6 + / - 7.4 mm Hg , p < 0.001 ) , body build ( BMI = 28.0 + / - 3.4 kg/m2 vs 23.9 + / - 2.5 kg/m2 , p < 0.001 ) , waist/hip ratio 0.98 + / - 0.04 vs 0.94 + / - 0.04 , p < 0.05 , as well as uric acid serum levels ( 413.7 + / - 111.0 mumol vs. 362.6 + / - 65.9 mumol/l , p < 0.05 ) and HDL cholesterol ( 1.36 + / - 0.30 mmol/l vs. 1.51 + / - 0.48 mmol/l , p < 0.05 ) .
RESULTS	However , the fasting blood sugar levels did not differ ( 5.2 + / - 0.7 mmol/l vs 5.1 + / - 0.6 mmol/l ) .
RESULTS	Although the index of insulin resistance was elevated ( 6.6 + / - 2.1 vs. 2.84 + / - 1.6 , p < 0.01 ) .
RESULTS	The blood sugar level rose steadily and reached a level of 18.7 % + / - 14.8 % ( p < 0.01 ) .
RESULTS	The increments of the blood sugar level correlated with changes in body weight ( 1.2 % + / - 6.1 % r = 0.535 , p < 0.001 ) , TAG ( 4.0 % + / - 5.6 % r = 0.332 , p < 0.05 ) and the fasting baseline blood sugar levels ( r = 0.551 , p < 0.001 ) .
RESULTS	The mentioned variables contributed to the prediction of increments of the blood sugar level in multiple regression ( determined coefficient R2 = 0.51 ) .
RESULTS	No relationship with the type of treatment was revealed .
RESULTS	11 % of the patients developed during the investigation period symptoms of type 2 diabetes .
RESULTS	The development of diabetes could be predicted on the basis of three baseline variables - the BMI , the index of insulin resistance and the basal blood sugar level ( logistic regression , r = 0.790 .
CONCLUSIONS	Hypertension is a constituent of the metabolic syndrome , although the rise of the blood sugar does not directly correlate with manifestation of type 2 diabetes , it is a warning that insulin resistance can influence the effectiveness of provisions of the therapeutic regimen , and last not least , also the development of type 2 diabetes .

###25567311
OBJECTIVE	To explore the acute toxic effects and early curative efficacy of concurrent chemotherapy with different doses of cisplatin for Chinese nasopharyngeal carcinoma ( NPC ) patients using intensity-modulated radiation therapy ( IMRT ) .
METHODS	Eighty-eight untreated stage II/III nasopharyngeal cancer patients receiving IMRT and concurrent cisplatin were randomized into two groups receiving different doses of cisplatin .
METHODS	The standard group ( DDP 100 mg/m q3w , n = 44 ) and the study group ( DDP 80 mg/m q3w , n = 44 ) .
METHODS	The acute toxic effects and 3-month therapeutic efficacy ( early curative efficacy ) in patients of the two groups who completed treatment were compared and analyzed .
RESULTS	During the treatment , grade III-IV acute toxic effects were observed in more patients of the standard group compared with that in the study group ( 72.7 % vs. 59.1 % ) , but the difference was statistically not significant ( P = 0.18 ) .
RESULTS	Significant difference was only seen in upper gastrointestinal reaction ( P = 0.01 ) and anemia ( P = 0.03 ) among the non-hematological and hematological adverse events .
RESULTS	No significant differences in other adverse events were found between the two groups ( P < 0.05 ) .
RESULTS	Three months after the completion of radiotherapy , 80 cases of the whole group achieved complete remission ( CR ) in the nasopharynx and neck MRI .
RESULTS	In both the standard group and study group , 40 patients had CR and 4 patients had residual disease , respectively , showing a non-significant difference ( P = 0.51 ) between the two groups .
CONCLUSIONS	During the IMRT course , patients received cisplatin 80 mg/m q3w , experienced less grade III-IV acute toxic effects .
CONCLUSIONS	Concurrent chemoradiotherapy with cisplatin 80 mg/m q3w or 100 mg/m q3w , demonstrate similar early curative efficacy in II/III stage NPC patients in endemic regions of China .

###1545849
BACKGROUND	The pathophysiologic aspects of pruritus in patients with chronic renal insufficiency are poorly understood , and there is no universally effective treatment .
BACKGROUND	The improvement of pruritus in several patients receiving erythropoietin therapy raised the possibility that erythropoietin affects uremic pruritus directly .
METHODS	We undertook a 10-week placebo-controlled , double-blind , crossover study in a group of patients receiving hemodialysis who had severe pruritus , to investigate the effects of recombinant human erythropoietin on their pruritus and plasma histamine levels .
METHODS	Twenty patients with uremia , of whom 10 had severe pruritus and 10 did not , received erythropoietin ( 36 units per kilogram of body weight three times weekly ) and placebo in random order , each for five weeks .
METHODS	The severity of pruritus was scored weekly , and plasma histamine levels were measured at the beginning and end of each five-week period .
RESULTS	Eight of the 10 patients with pruritus had marked reductions in their pruritus scores during erythropoietin therapy .
RESULTS	The mean ( + / - SE ) pruritus score decreased from 25 + / - 3 to 6 + / - 1 in these patients .
RESULTS	The pruritus returned within one week after the discontinuation of therapy .
RESULTS	The improvement was not related to the change in hemoglobin level .
RESULTS	These eight patients were successfully treated again with low doses of erythropoietin ( 18 units per kilogram three times weekly ) , and the effect has persisted for six months .
RESULTS	The patients with pruritus had elevated plasma histamine concentrations ( 20.7 + / - 2.7 nmol per liter ) , as compared with the patients without pruritus ( 4.2 + / - 0.6 nmol per liter ; P less than 0.001 ) and normal subjects ( 2.1 + / - 0.2 nmol per liter ; P less than 0.001 ) .
RESULTS	Therapy with erythropoietin induced a decrease in plasma histamine concentrations in both groups of patients with uremia , and recurrences of pruritus after the discontinuation of erythropoietin were accompanied by increases in plasma histamine concentrations .
CONCLUSIONS	Erythropoietin therapy lowers plasma histamine concentrations in patients with uremia and can result in marked improvement of pruritus .

###10700435
OBJECTIVE	The aim of this prospective study was to find if a complete synovial fluid aspiration before injecting intra-articular corticosteroids influences the treatment result .
METHODS	The study was performed in 147 patients with rheumatoid arthritis ( RA ) .
METHODS	One hundred and ninety one knees with synovitis were randomised to arthrocentesis ( n = 95 ) or no arthrocentesis ( n = 96 ) before 20 mg triamcinolone hexacetonide was injected .
METHODS	The duration of effect was followed up for a period of six months .
METHODS	All patients were instructed to contact the rheumatology department if signs and symptoms from the treated knee recurred .
METHODS	If arthritis could be confirmed by a clinical examination a relapse was noted .
RESULTS	There was a significant reduction of relapse in the arthrocentesis group ( p = 0.001 ) .
CONCLUSIONS	The study shows that aspiration of synovial fluid can reduce the risk for arthritis relapse when treating RA patients with intra-articular corticosteroids .
CONCLUSIONS	It is concluded that arthrocentesis shall be included in the intra-articular corticosteroid injection procedure .

###20578849
OBJECTIVE	To evaluate the success of osseointegrated implants under immediate prosthetic and orthodontic forces after a follow-up period of at least 2 years .
METHODS	The sample included 20 titanium implants which were used as orthodontic and prosthetic anchorage of immediately loaded single-crowns on a total of 13 patients .
METHODS	A 40 N initial torque was considered the minimum for inclusion in the sample .
METHODS	All implants received screwed provisional crowns immediately after surgery .
METHODS	The implants were randomly divided into two groups : the control group ( 9 implants ) and the immediate orthodontic loading group ( 11 implants ) .
METHODS	A healing period of 4 months was observed before orthodontic loads were applied to the control group implants .
METHODS	For the immediate orthodontic loading group , orthodontic forces were applied within 24 hours .
METHODS	The maximum orthodontic force applied in both groups was 200 g.
METHODS	After 6 months of orthodontic movement , clinical and radiographic evaluations were obtained .
METHODS	Implants were considered successful when favorable results were obtained in all evaluations .
RESULTS	After a 2-year follow-up , the success rates were 90.9 % and 88.9 % , respectively , in the orthodontic loading group and the control group .
RESULTS	Each group had one failure .
CONCLUSIONS	Shortening the healing period for the application of orthodontic forces did not seem to affect the success of osseointegrated implants used as anchorage .

###26165528
BACKGROUND	High-concentration normobaric oxygen ( O ) administration is the first-aid priority in treating divers with suspected decompression illness .
BACKGROUND	The best O delivery device and flow rate are yet to be determined .
OBJECTIVE	To determine whether administering O with a non-rebreather mask ( NRB ) at a flow rate of 10 or 15 Lmin or with a demand valve with oronasal mask significantly affects the tissue partial pressure of O ( PtcO ) in healthy volunteer scuba divers .
METHODS	Fifteen certified scuba divers had PtcO measured at six positions on the arm and leg .
METHODS	Measurements were taken with subjects lying supine whilst breathing O from a NRB at 10 or 15Lmin , a demand valve with an adult Tru-Fit oronasal mask and , as a reference standard , an oxygen ` head hood ' .
METHODS	End-tidal carbon dioxide was also measured .
RESULTS	While none of the emergency delivery devices performed as well as the head hood , limb tissue oxygenation was greatest when O was delivered via the NRB at 15 Lmin .
RESULTS	There were no clinically significant differences in end-tidal carbon dioxide regardless of the delivery device or flow rate .
CONCLUSIONS	Based on transcutaneous oximetry values , of the commonly available emergency O delivery devices , the NRB at 15 Lmin is the device and flow rate that deliver the most O to body tissues and , therefore , should be considered as a first-line pre-hospital treatment in divers with suspected decompression illness .

###20415689
OBJECTIVE	To investigate the influence of obesity in type 2 diabetic patients upon pharmacological properties of different biphasic preparations of insulin aspart .
METHODS	A total of 75 type 2 diabetic patients were stratified according to their body mass index ( BMI ) into 40 non-obese ( BMI 23-28 kg/m ( 2 ) ) and 35 obese ( BMI 30-35 kg/m ( 2 ) ) subjects .
METHODS	The trial was a double-blinded crossover study .
METHODS	In two periods of 4 weeks each the patients received subcutaneous injections of biphasic insulin aspart 50 ( BIAsp 50 ) or biphasic insulin aspart 70 ( BIAsp 70 ) thrice daily in random order .
METHODS	Insulin doses were titrated individually .
METHODS	At the end of each period 24-h serum profiles of insulin aspart , C-peptide and glucose were recorded .
METHODS	The primary endpoint was the area under the curve of serum glucose concentration during 24 h ( AUC ( Glu ) ( 0-24 h ) ) .
RESULTS	The insulin concentration profiles of BIAsp 50 and 70 were as expected according to the content of protamine-bound insulin aspart ( 50 and 30 % respectively ) .
RESULTS	AUC ( Glu ( 0-24 h ) ) BIAsp 50/BIAsp 70 ratios were 0.97 ( 95 % CI : 0.90-1 .05 , p = 0.49 ) for non-obese and 0.98 ( 95 % CI : 0.92-1 .05 , p = 0.55 ) for obese .
RESULTS	Fasting serum glucose ( FSG ) BIAsp 50/BIAsp 70 ratios were 0.90 ( 95 % CI : 0.84-0 .96 , p = 0.002 ) for non-obese and 0.90 ( 95 % CI : 0.84-0 .97 , p = 0.006 ) for obese .
RESULTS	During both treatment regimens the frequency of minor hypoglycaemic episodes was highest for the non-obese group .
CONCLUSIONS	The pharmacokinetic and pharmacodynamic characteristics of the two preparations of biphasic insulin aspart were different ; however , they were not influenced by the degree of obesity in type 2 diabetic patients .

###17935024
OBJECTIVE	We have conducted a prospective study to evaluate the results and effectiveness of bilateral decompression via a unilateral laminectomy in 50 patients with 98 levels of degenerative lumbar spinal stenosis without instability .
METHODS	Clinical outcomes were assessed using the Visual Analog Scale , Oswestry Disability Index , Short Form-36 , and subjective Satisfaction Measurement .
RESULTS	Adequate decompression was achieved in all patients .
RESULTS	The mean follow-up time was 22.8 months ( range 19 - 47 months ) .
RESULTS	Surgical decompression resulted in a dramatic reduction of overall pain in all patients ( late postoperative VAS score was 2.16 + / - 0.81 ) .
RESULTS	The ODI scores decreased significantly in early and late follow-up evaluations and the SF-36 scores demonstrated significant improvement in late follow-up results in our series .
RESULTS	Patient satisfaction rate was 94 % , and its improvement rate was 96 % .
CONCLUSIONS	For degenerative lumbar spinal stenosis with or without mild degenerative spondylolisthesis , the unilateral approach allowed sufficient and safe decompression of the neural structures and adequate preservation of vertebral stability , resulted in a highly significant reduction of symptoms and disability , and improved health-related quality of life .

###23582867
OBJECTIVE	To assess the efficacy of trauma-focused cognitive behavioral therapy ( TF-CBT ) delivered by nonclinical facilitators in reducing posttraumatic stress , depression , and anxiety and conduct problems and increasing prosocial behavior in a group of war-affected , sexually exploited girls in a single-blind , parallel-design , randomized , + controlled trial .
METHODS	Fifty-two 12 - to 17-year-old , war-affected girls exposed to rape and inappropriate sexual touch in the Democratic Republic of Congo were screened for trauma , depression and anxiety , conduct problems , and prosocial behavior .
METHODS	They were then randomized to a 15 session , group-based , culturally modified TF-CBT ( n = 24 ) group or a wait-list control group ( n = 28 ) .
METHODS	Primary analysis , by intention-to-treat , involving all randomly assigned participants occurred at pre - and postintervention and at 3-month follow-up ( intervention group only ) .
RESULTS	Compared to the wait list control , the TF-CBT group experienced significantly greater reductions in trauma symptoms ( F ( 1,49 ) = 52.708 , p < 0001 , ( p ) 2 = 0.518 ) .
RESULTS	In addition , the TF-CBT group showed a highly significant improvement in symptoms of depression and anxiety , conduct problems , and prosocial behavior .
RESULTS	At 3-months follow-up the effect size ( Cohen 's d ) for the TF-CBT group was 2.04 ( trauma symptoms ) , 2.45 ( depression and anxiety ) , 0.95 ( conduct problems ) , and-1 .57 ( prosocial behavior ) .
CONCLUSIONS	A group-based , culturally modified , TF-CBT intervention delivered by nonclinically trained Congolese facilitators resulted in a large , statistically significant reduction in posttraumatic stress symptoms and psychosocial difficulties among war-affected girls exposed to rape or sexual violence .
CONCLUSIONS	Clinical trial registration information-An RCT of TF-CBT with sexually-exploited , war-affected girls in the DRC ; http://clinicaltrials.gov/; NCT01483261 .

###7748680
OBJECTIVE	This study compares the use of standard overhead fluorescent phototherapy units with the BiliBlanket a woven fibreoptic pad which delivers high intensity light with no ultraviolet or infrared irradiation in the treatment of jaundice in preterm infants .
METHODS	We chose to study infants between 800 and 2500 g , with strict criteria for commencing and ceasing phototherapy .
METHODS	Serum bilirubin levels were followed at 12-24 h intervals until 24 h after cessation of phototherapy .
METHODS	Infants were allocated at random to receive either conventional phototherapy or the BiliBlanket .
RESULTS	There were 24 infants in the conventional group and 20 in the BiliBlanket group .
RESULTS	Mean duration of phototherapy was compared and was 44 h for the conventional group versus 42 h for the BiliBlanket group .
CONCLUSIONS	We have shown that the BiliBlanket is as effective as conventional phototherapy and was well accepted by nursing staff and parents .

###8829420
OBJECTIVE	This study was undertaken to determine whether preoperative spinal anesthesia with local anesthetics would exert a pre-emptive effect on postoperative analgesia by reducing neural afferent stimulation .
METHODS	The authors studied 38 healthy women undergoing total abdominal hysterectomy .
METHODS	Patients were randomly allocated to two groups : group A received a spinal block ( T3-S5 ) prior to induction of anesthesia and surgery , while in group B the block was performed after surgery prior to extubation of the trachea .
METHODS	Patient-controlled analgesia morphine was administered to both groups during the first 24 postoperative hours .
RESULTS	Pain and sedation scores at 6 , 12 , and 24 hours were similar in the two groups .
RESULTS	Cumulative morphine consumption at 6 and 24 hours after surgery was similar in both groups ; however at 12 hours more morphine was needed in group A ( P < .02 ) .
CONCLUSIONS	The authors were unable to demonstrate that spinal block with bupivacaine before surgery , as opposed to after surgery , decreased the requirement of morphine in the postoperative period .

###17419222
OBJECTIVE	Since the first successful laparoscopic cholecystectomy with the establishment of pneumoperitoneum in France by Mouret in 1987 , it has become the golden standard for cholecystectomy .
OBJECTIVE	Generally techniques with four trocars have been used with surgeons but some of them prefer 3-trocar techniques .
OBJECTIVE	Our aim is to compare the clinical outcomes of three - and four-port techniques prospectively .
METHODS	Between 1998 and 2003 , one hundred and forty-six consecutive patients who underwent elective laparoscopic cholecystectomy for cholelithiasis in the Medical Faculty of Suleyman Demirel University were randomized to receive either the three-port or the four-port technique .
METHODS	Operative time , ( time from the beginning of the insufflation up to the closure of the skin ) , success rate , visual analogue pain score , analgesia requirements , postoperative hospital stay were compared .
RESULTS	No differences between the two groups could be found .
CONCLUSIONS	Three-port technique is safe , effective , and economic but does not reduce the overall pain score and analgesia requirement .

###20154079
BACKGROUND	In cases of pleural effusion , tissue samples can be obtained through Abrams needle pleural biopsy ( ANPB ) , thoracoscopy , or cutting-needle pleural biopsy under the guidance of CT scan ( CT-CNPB ) for histopathologic analysis .
BACKGROUND	This study aimed to compare the diagnostic efficiency and reliability of ANPB under CT scan guidance ( CT-ANPB ) with that of medical thoracoscopy in patients with pleural effusion .
METHODS	Between January 2006 and January 2008 , 124 patients with exudative pleural effusion that could not be diagnosed by cytologic analysis were included in the study .
METHODS	All patients were randomized after the CT scan was performed .
METHODS	Patients either underwent CT-ANPB or thoracoscopy .
METHODS	The two groups were compared in terms of diagnostic sensitivity and complications associated with the methods used .
RESULTS	Of the 124 patients , malignant mesothelioma was diagnosed in 33 , metastatic pleural disease in 47 , benign pleural disease in 42 , and two were of indeterminate origin .
RESULTS	In the CT-ANPB group , the diagnostic sensitivity was 87.5 % , as compared with 94.1 % in the thoracoscopy group ; the difference was not statistically significant ( P = .252 ) .
RESULTS	No difference was identified between the sensitivities of the two methods based on the cause , the CT scan findings , and the degree of pleural thickening .
RESULTS	Complication rates were low and acceptable .
CONCLUSIONS	We recommend the use of CT-ANPB as the primary method of diagnosis in patients with pleural thickening or lesions observed by CT scan .
CONCLUSIONS	In patients with only pleural fluid appearance on CT scan and in those who may have benign pleural pathologies other than TB , the primary method of diagnosis should be medical thoracoscopy .
BACKGROUND	clinicaltrials.gov ; Identifier : NCT00720954 .

###25085960
BACKGROUND	The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery ( SYNTAX ) trial demonstrated that in patients with 3-vessel or left main coronary artery disease , coronary artery bypass graft surgery ( CABG ) was associated with a lower rate of cardiovascular death , myocardial infarction , stroke , or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents ( DES-PCI ) ) .
BACKGROUND	The long-term cost-effectiveness of these strategies is unknown .
RESULTS	Between 2005 and 2007 , 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG ( n = 897 ) or DES-PCI ( n = 903 ) .
RESULTS	Costs were assessed from a US perspective , and health state utilities were evaluated with the EuroQOL questionnaire .
RESULTS	A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs , life expectancy , and quality-adjusted life expectancy over a lifetime horizon .
RESULTS	Although initial procedural costs were $ 3415 per patient lower with CABG , total hospitalization costs were $ 10 036 per patient higher .
RESULTS	Over the next 5 years , follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations , revascularization procedures , and higher medication costs .
RESULTS	Over a lifetime horizon , CABG remained more costly than DES-PCI , but the incremental cost-effectiveness ratio was favorable ( $ 16 537 per quality-adjusted life-year gained ) and remained < $ 20 000 per quality-adjusted life-year in most bootstrap replicates .
RESULTS	Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs .
RESULTS	In patients with left main disease or a SYNTAX score 22 , however , DES-PCI was economically dominant compared with CABG , although these findings were less certain .
CONCLUSIONS	For most patients with 3-vessel or left main coronary artery disease , CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI .
CONCLUSIONS	However , among patients with less complex disease , DES-PCI may be preferred on both clinical and economic grounds .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00114972 .

###17380360
BACKGROUND	Postoperative pain has always been underestimated by the majority of plastic surgeons .
BACKGROUND	A prospective randomized trial compared power water-assisted liposuction with the traditional tumescent technique .
METHODS	All patients with a body mass index ( BMI ) of 25 to 30 and excessive localized pathologic fat were recruited .
METHODS	Exclusion criteria specified a BMI greater than 30 or redundant anelastic skin .
METHODS	Patients were randomly assigned to power water-assisted or traditional liposuction .
RESULTS	From September 2005 to December 2005 , 60 patients were recruited and analyzed .
RESULTS	For the study , 28 patients were randomized to traditional liposuction and 32 to power water-assisted liposuction .
RESULTS	A significant difference in postoperative pain was observed ( p < 0.05 ) .
RESULTS	After 4 days , 87 % of the patients who underwent power water-assisted liposuction were completely pain free , as compared with 3.6 % of those treated with traditional liposuction .
RESULTS	Furthermore , ecchymosis was significantly less for the patients who underwent power-assisted liposuction ( p < 0.05 ) .
CONCLUSIONS	The study findings demonstrate that power water-assisted liposuction is an almost painless procedure that produces less tissue trauma than traditional liposuction .

###15187074
OBJECTIVE	The aim of this study was to evaluate the experiences of patients and physicians in a clinical trial of an online electronic medical record ( SPPARO , System Providing Patients Access to Records Online ) .
METHODS	Quantitative data were obtained from questionnaires .
METHODS	Qualitative data were obtained from individual interviews and focus groups .
METHODS	Questionnaire items were based on issues identified by patients and physicians in previous studies .
METHODS	Individual interviews and focus groups were performed using a semistructured format developed through an iterative process .
RESULTS	Of the eight physicians who participated in the trial , seven completed questionnaires and interviews .
RESULTS	Of the 394 patients in the practice , 107 enrolled in the study , and 54 were assigned randomly to the intervention group .
RESULTS	Of these , 41 used SPPARO during the trial period .
RESULTS	In questionnaires and interviews , patients were significantly more likely than physicians to anticipate benefits of SPPARO and less likely to anticipate problems .
RESULTS	Attitudes of subjects did not diverge from controls after the intervention period .
RESULTS	In posttrial focus groups , SPPARO users described its practical benefits .
RESULTS	Comprehending medical jargon was a minor obstacle .
RESULTS	Physicians anticipated that implementing SPPARO might increase their workload and distort their clinical interactions .
RESULTS	In posttrial interviews , physicians and staff reported no change in their workload and no adverse consequences .
RESULTS	All of the physicians ultimately supported the concept of giving patients online access to their clinical notes and test results .
CONCLUSIONS	SPPARO was useful for a number of patients .
CONCLUSIONS	Physicians initially voiced a number of concerns about implementing SPPARO , but their experience with it was far more positive .

###16670616
OBJECTIVE	Somatostatin inhibitory effect on the exocrine pancreas has been demonstrated by clinical and experimental studies performed with invasive investigative methods .
OBJECTIVE	The aim of this study was to quantify the inhibitory effect of low doses of somatostatin ( 62.5 , 125 , and 250 microg ) on secretin-stimulated pancreatic exocrine secretions using magnetic resonance cholangiopancreatography ( MRCP ) .
METHODS	Ten healthy volunteers underwent 4 MRCP at a 1-week interval .
METHODS	At each MRCP , 1 of the 3 doses of Somatostatin or the placebo was given by the intravenous route for a period of 40 minutes .
METHODS	After 20 minutes from the beginning of drug infusion , secretin was injected ( 0.3 CU/kg ) .
METHODS	MRCP was performed before and every 30 to 45 seconds for 15 minutes after secretin administration .
METHODS	Pancreatic exocrine secretions were quantified by the measurements of pancreatic flow output and total excreted volume , derived from a linear regression between MRCP calculated volumes and time .
RESULTS	For the 3 doses of somatostatin , pancreatic flow output was significantly reduced compared to placebo ( P < 0.05 ) .
RESULTS	Total excreted volume was significantly reduced only for the doses of 62.5 and 250 microg .
RESULTS	No statistical significant differences were observed among the 3 doses .
CONCLUSIONS	Low doses of somatostatin inhibit pancreatic exocrine secretions as demonstrated noninvasively with MRCP .

###25359007
BACKGROUND	Forming ` habit ' - defined as a learned process that generates automatic responses to contextual cues - has been suggested as a mechanism for behaviour maintenance , but few studies have applied habit theory to behaviour change .
BACKGROUND	This study used process evaluation data , taken from a randomised controlled trial of a healthy child-feeding intervention for parents previously shown to be effective , to explore the applicability to dietary behaviour change of predictions and recommendations drawn from habit theory .
BACKGROUND	The intervention supported parents in pursuing child-feeding habit goals in three domains ( giving fruit and vegetables , water , healthy snacks ) , over four fortnightly home visits .
BACKGROUND	We explored whether ( a ) the habit-formation model was acceptable to participants , ( b ) better-specified habit-formation goals yielded greater habit gains , and ( c ) habit gains were sustained ( d ) even when subsequent , new habit goals were pursued .
METHODS	Qualitative and quantitative data were taken from 57 parents randomised to the intervention arm , and so analyses presented here used a pre-post intervention design .
METHODS	Thematic analysis of post-intervention qualitative interviews evaluated acceptability , and self-reported habit goals were content-analysed .
METHODS	ANOVAs explored changes in habit strength , recorded at home visits and one - and two-month follow-ups , across time and goals .
RESULTS	Participants understood and engaged positively with the habit-formation approach .
RESULTS	Although many seemingly poorly-specified habit goals were set , goal characteristics had minimal impact on habit strength , which were achieved within two weeks for all behaviours ( p 's < .001 ) , and were maintained or had increased further by the final follow-up .
CONCLUSIONS	The habit-formation model appears to be an acceptable and fruitful basis for dietary behaviour change .

###17910898
BACKGROUND	The abdominal muscles provide stiffness to the torso in a manner that is not well understood .
BACKGROUND	Their unique anatomical arrangement may modify their stiffening ability with respect to the more commonly studied long strap-like muscles of the limbs .
BACKGROUND	The purpose of this study was to examine stiffness inherent to the trunk , as modified by different torso , and in particular , abdominal muscle activation levels .
METHODS	Nine healthy male participants were secured in a `` frictionless '' apparatus and subjected to applied bending moments about either the flexion/extension or lateral bend axes .
METHODS	Abdominal muscle activation levels were modified through biofeedback from the right external oblique muscle .
METHODS	Moment-angle curves were generated and characterized by an exponential function for each of flexion , extension , and right-side lateral bend , at each of four abdominal muscle activation target level conditions .
RESULTS	Stiffness measured in extension increased in a linear fashion throughout the range of motion and increased with each successive rise in abdominal activation .
RESULTS	Stiffness in flexion and lateral bend increased in an exponential fashion over the range of motion .
RESULTS	In flexion and lateral bend , stiffness increased with each successive rise in abdominal activation from zero to approximately 40 % and 60 % of the range of motion , respectively .
RESULTS	After these points , stiffness at the highest levels of activation displayed a `` yielding '' phenomenon whereby the torso stiffness dropped below that characterized at lower levels of activation .
CONCLUSIONS	Increasing torso muscle co-activation leads to a rise in trunk stiffness over postures most commonly adopted by individuals through daily activities ( neutral to approximately 40 % of maximum range of motion ) .
CONCLUSIONS	However , towards the end range of motion in both flexion and lateral bend , individuals became less stiff at the maximum abdominal muscle co-activation levels .
CONCLUSIONS	The source and mechanism of this apparent yielding are not fully understood ; future work will be directed toward elucidating the cause .

###11477844
OBJECTIVE	To assess the clinical effects of Yishen Shengxue tablet ( YSSXT ) on aplastic anemia .
METHODS	All patients were divided into two groups by simple randomized methods , 106 patients of the treatment group were treated with YSSXT , 36 patients of the control groups were treated with Renshen Guipi Pill ( RSGPP ) .
METHODS	Peripheral blood and bone marrow of the two groups of patients were measured before and after treatment .
METHODS	The toxicity and side effects of YSSXT were also observed .
RESULTS	The basical cure rate , remission rate , total effective rate of the treatment and control groups were 23.6 % , 36.8 % , 82.1 % and 11.1 % , 22.2 % , 58.3 % respectively .
RESULTS	There was significant difference between the two groups ( P < 0.05 and P < 0.001 ) .
RESULTS	The effect of treatment group was obviously better than that of control group .
RESULTS	Follow up study showed that from onset of the disease to follow up time in the treatment group , the longest one was 18 years 4 months , so the long-term curative effect is promising .
RESULTS	During the period of clinical observation , no obvious side effect and toxicity of YSSXT were found .
CONCLUSIONS	YSSXT is an effective and safe drug in treating aplastic anemia .
CONCLUSIONS	It has a good prospect and application .

###11837227
BACKGROUND	It has recently been demonstrated that the lipid profile of smokers improves if they follow a Mediterranean diet .
OBJECTIVE	To establish whether the Sstl polymorphism of the apo C-III gene interacts with smoking and determines the lipid response to diet in healthy subjects .
RESULTS	Fifty-nine volunteers ( 18 smokers : 8 with the S1S1 genotype , and 10 with the S2 allele ; 41 non-smokers : 29 with the S1S1 genotype and 12 with the S1S2 genotype ) consecutively followed three different diets : a diet enriched in saturated fatty acids ( SFA ) ( 38 % fat , 20 % SFA ) followed by a randomised , cross-over period during which they ate a diet enriched in carbohydrates ( NCEP-1 ) ( 30 % fat , 10 % SFA , 55 % carbohydrates ) and a diet enriched in monounsaturated fatty acids ( MUFA ) ( 8 % fat , 22 % MUFA ) .
RESULTS	Cholesterol , triacylglycerol , LDL-cholesterol ( LDL-C ) and HDL-cholesterol ( HDL-C ) levels were measured at the end of each dietary period .
RESULTS	The smokers carrying the S1S1 genotype were not influenced by any of the diets , but the atherogenic ratio decreased in the carriers of the S2 allele when they changed from the diet rich in SFA to a diet rich in olive oil or carbohydrates ( p < 0.039 ) .
RESULTS	No significant difference was observed when the non-smoking carriers of the S2 allele changed from one diet to another , but there was a decrease in the LDL-C/HDL-C ratio when the subjects with the S1S1 genotype changed from the saturated diet to either of the other diets ( p < 0.001 ) .
CONCLUSIONS	Smoking interacts with the apo CM polymorphism and determines the level of lipid response to dietary changes .

###25391338
BACKGROUND	Cryptococcal meningitis ( CM ) is a severe AIDS-defining illness with 90-day case mortality as high as 70 % in sub-Saharan Africa , despite treatment .
BACKGROUND	It is the leading cause of death in HIV patients in Asia and Africa.No major advance has been made in the treatment of CM since the 1970s .
BACKGROUND	The mainstays of induction therapy are amphotericin B and flucytosine , but these are often poorly available where the disease burden is highest .
BACKGROUND	Adjunctive treatments , such as dexamethasone , have had dramatic effects on mortality in other neurologic infections , but are untested in CM .
BACKGROUND	Given the high death rates in patients receiving current optimal treatment , and the lack of new agents on the horizon , adjuvant treatments , which offer the potential to reduce mortality in CM , should be tested.The principal research question posed by this study is as follows : does adding dexamethasone to standard antifungal therapy for CM reduce mortality ?
BACKGROUND	Dexamethasone is a cheap , readily available , and practicable intervention .
METHODS	A double-blind placebo-controlled trial with parallel arms in which patients are randomised to receive either dexamethasone or placebo , in addition to local standard of care .
METHODS	The study recruits patients in both Asia and Africa to ensure the relevance of its results to the populations in which the disease burden is highest .
METHODS	The 10-week mortality risk in the control group is expected to be between 30 % and 50 % , depending on location , and the target hazard ratio of 0.7 corresponds to absolute risk reductions in mortality from 30 % to 22 % , or from 50 % to 38 % .
METHODS	Assuming an overall 10-week mortality of at least 30 % in our study population , recruitment of 824 patients will be sufficient to observe the expected number of deaths .
METHODS	Allowing for some loss to follow-up , the total sample size for this study is 880 patients .
METHODS	To generate robust evidence across both continents , we aim to recruit roughly similar numbers of patients from each continent .
METHODS	The primary end point is 10-week mortality .
METHODS	Ethical approval has been obtained from Oxford University 's Tropical Research Ethics Committee ( OxTREC ) , and as locally mandated at each site .
BACKGROUND	International Standard Randomised Controlled Trial Number : ISRCTN59144167 26-July-2012 .

###19552810
BACKGROUND	Ethnic minority ( EM ) medical students and doctors underperform academically , but little evidence exists on how to ameliorate the problem .
BACKGROUND	Psychologists Cohen et al. recently demonstrated that a written self-affirmation intervention substantially improved EM adolescents ' school grades several months later .
BACKGROUND	Cohen et al. 's methods were replicated in the different setting of UK undergraduate medical education .
METHODS	All 348 Year 3 white ( W ) and EM students at one UK medical school were randomly allocated to an intervention condition ( writing about one 's own values ) or a control condition ( writing about another 's values ) , via their tutor group .
METHODS	Students and assessors were blind to the existence of the study .
METHODS	Group comparisons on post-intervention written and OSCE ( clinical ) assessment scores adjusted for baseline written assessment scores were made using two-way analysis of covariance .
METHODS	All assessment scores were transformed to z-scores ( mean = 0 standard deviation = 1 ) for ease of comparison .
METHODS	Comparisons between types of words used in essays were calculated using t-tests .
METHODS	The study was covered by University Ethics Committee guidelines .
RESULTS	Groups were statistically identical at baseline on demographic and psychological factors , and analysis was by intention to treat [ intervention group EM n = 95 , W n = 79 ; control group EM n = 77 ; W n = 84 ] .
RESULTS	As predicted , there was a significant ethnicity by intervention interaction [ F ( 4,334 ) = 5.74 ; p = 0.017 ] on the written assessment .
RESULTS	Unexpectedly , this was due to decreased scores in the W intervention group [ mean difference = 0.283 ; ( 95 % CI = 0.093 to 0.474 ] not improved EM intervention group scores [ mean difference = -0.060 ( 95 % CI = -0.268 to 0.148 ) ] .
RESULTS	On the OSCE , both W and EM intervention groups outperformed controls [ mean difference = 0.261 ; ( 95 % CI = -0.047 to -0.476 ; p = 0.013 ) ] .
RESULTS	The intervention group used more optimistic words ( p < 0.001 ) and more `` I '' and `` self '' pronouns in their essays ( p < 0.001 ) , whereas the control group used more `` other '' pronouns ( p < 0.001 ) and more negations ( p < 0.001 ) .
CONCLUSIONS	Cohen et al. 's finding that a brief self-affirmation task narrowed the ethnic academic achievement gap was replicated on the written assessment but against expectations , this was due to reduced performance in the W group .
CONCLUSIONS	On the OSCE , the intervention improved performance in both W and EM groups .
CONCLUSIONS	In the intervention condition , participants tended to write about themselves and used more optimistic words than in the control group , indicating the task was completed as requested .
CONCLUSIONS	The study shows that minimal interventions can have substantial educational outcomes several months later , which has implications for the multitude of seemingly trivial changes in teaching that are made on an everyday basis , whose consequences are never formally assessed .

###14574830
OBJECTIVE	To evaluate the efficacy of methylphenidate in treating adults with attention-deficit hyperactivity disorder ( ADHD ) , using subjective ( self-report ) and objective ( computerized test ) measures .
METHODS	This double-blind crossover trial of placebo vs methylphenidate included subjects with childhood and current ADHD symptoms , IQs above 80 , no other psychiatric condition explaining their difficulties or requiring other treatment , and no substance abuse in the previous 6 months .
METHODS	We administered 10 mg 3 times daily of medication ( that is , placebo or methylphenidate ) for 2 weeks .
METHODS	On the final day , subjects completed self-report measures and were tested on computerized tests .
METHODS	We then increased dosage to 15 mg 3 times daily for 2 weeks and administered a complete reassessment on the final day .
METHODS	Following a 1-week washout , we repeated this process on the second medication ( that is , placebo or methylphenidate ) .
RESULTS	Thirty adults with ADHD participated .
RESULTS	Self-report measures and computerized tests showed significant improvements in ADHD symptoms on methylphenidate , compared with placebo .
RESULTS	Other psychiatric symptoms ( notably , anxiety and depression ) were alleviated with methylphenidate .
RESULTS	There was no significant difference between the 2 dosages of methylphenidate .
CONCLUSIONS	Methylphenidate is effective in improving ADHD symptoms in adults with ADHD , is well tolerated , and has minimal side effects .

###19111408
OBJECTIVE	Few studies have examined the association between genetic variants of the estrogen receptor beta ( ESR2 ) and obesity in postmenopausal women .
METHODS	The relationship of three polymorphisms ( rs1271572 , rs1256049 and rs4986938 ) and their associated haplotypes in the ESR2 gene with obesity and overweight were evaluated in 561 apparently healthy women ( median age 63 years ) from the Women 's Health Study .
METHODS	Most of the women were postmenopausal ( 99.1 % ) .
METHODS	The associations between genotypes and haplotypes with obesity ( BMI > or = 30kg/m ( 2 ) ) and overweight ( BMI > or = 25kg/m ( 2 ) ) were evaluated by logistic regression , assuming an additive model .
RESULTS	No association was observed for any of the three polymorphisms with BMI , overweight or obesity .
RESULTS	In haplotype analyses , one haplotype ( major allele for all polymorphisms ) was associated with a borderline inverse association with overweight but not obesity ( OR = 0.62 , 95 % CI = 0.39-0 .98 ) .
CONCLUSIONS	An inverse and borderline significant association was found between the ESR2 G-G-G haplotype and overweight in postmenopausal women .
CONCLUSIONS	Further investigation regarding the association between ESR2 and adiposity should be performed to confirm these findings .

###23609341
BACKGROUND	Few studies have evaluated how to combine dietary and physical activity ( PA ) interventions to enhance adherence .
OBJECTIVE	We tested how sequential versus simultaneous diet plus PA interventions affected behavior changes .
METHODS	Two hundred participants over age 44 years not meeting national PA and dietary recommendations ( daily fruit and vegetable servings and percent of calories from saturated fat ) were randomized to one of four 12-month telephone interventions : sequential ( exercise first or diet first ) , simultaneous , or attention control .
METHODS	At 4 months , the other health behavior was added in the sequential arms .
RESULTS	Ninety-three percent of participants were retained through 12 months .
RESULTS	At 4 months , only exercise first improved PA , and only the simultaneous and diet-first interventions improved dietary variables .
RESULTS	At 12 months , mean levels of all behaviors in the simultaneous arm met recommendations , though not in the exercise - and diet-first arms .
CONCLUSIONS	We observed a possible behavioral suppression effect of early dietary intervention on PA that merits investigation .

###21067858
OBJECTIVE	To find the optimal dosage of estradiol ( E2 ) for luteal phase support through the addition of different doses of E2 to progeserone ( P ) luteal phase support in patients undergoing long GnRH agonist in vitro fertilization ( IVF ) treatments .
METHODS	Two hundred and eighty-five women undergoing IVF treatment with a long GnRH agonist protocol were prospectively randomized into three groups .
METHODS	Group 1 ( n = 95 ) received P and 2mg E2 , group 2 ( n = 95 ) received P and 4 mg E2 and group 3 ( n = 95 ) received P and 6 mg E2 as luteal phase support .
METHODS	The primary outcome was the clinical pregnancy rate ( PR ) .
METHODS	The secondary variables of interest were the implantation rate ( IR ) , miscarriage rate and multiple PR .
RESULTS	The clinical PR was 31.6 % , 40 % and 32 % respectively in groups 1 , 2 and 3 and the differences between groups were not statistically significant .
RESULTS	However , the miscarriage rate was significantly lower in group 2 ( 2.6 % ) than in group 1 ( 20 % ) but was not significantly lower than in group 3 ( 9.6 % ) .
CONCLUSIONS	For luteal phase support , adding 2 , 4 or 6 mg of oral E2 to P creates no statistical difference in terms of pregnancy rates .
CONCLUSIONS	However , a significantly higher miscarriage rate was found when 2mg E2 was used .
CONCLUSIONS	Therefore , in the luteal phase support , 4 mg of oral estradiol in addition to progesterone can be considered to reduce the miscarriage rate .
CONCLUSIONS	For luteal phase support , adding 2 , 4 or 6 mg of oral estradiol to progesterone showed no statistical difference in terms of pregnancy and implantation rates , but a significantly higher miscarriage rate was found when 2mg estradiol was used .

###16781967
OBJECTIVE	To compare the effectiveness of a Web-based physical activity ( PA ) intervention with identical content delivered in a printed workbook among a sample of adolescent girls .
METHODS	Participants consisted of 319 girls with home Internet access enrolled in four middle schools within one school district .
METHODS	A randomized trial design was used to compare changes in PA self-efficacy and intentions after two weeks of exposure to either a Web - or print-based intervention delivered to their home .
METHODS	Self-reported physical activity was assessed as a secondary outcome .
METHODS	Analysis of covariance was conducted to determine changes between the intervention groups while controlling for baseline levels of PA constructs .
RESULTS	Both Web and print groups had significant changes in physical activity self-efficacy ( Web : t [ 155 ] = 2.58 , p = .01 ; print : t [ 156 ] = 3.11 , p = .002 ) and intentions ( Web : t [ 157 ] = 2.27 , p = .02 ; print : t [ 159 ] = 6.32 , p < or = .001 ) .
RESULTS	The print group demonstrated significantly greater increases in intentions compared with the Web group ( F [ 1,315 ] = 13.53 , p < or = .001 ) .
RESULTS	Self-reported physical activity increased significantly in the print group only ( t [ 159 ] = 3.21 , p = .002 ) .
CONCLUSIONS	It can not be assumed that new media technologies are superior to traditional media such as print for health communication to adolescents .
CONCLUSIONS	These results suggest that a printed workbook was more effective than an identical website for increasing physical activity intentions and behavior among a sample of middle school girls .

###15659491
OBJECTIVE	Overexpression of the epidermal growth factor receptor has been demonstrated in advanced prostate cancer and is associated with a poor outcome .
OBJECTIVE	A multi-institutional , randomized , phase II study was undertaken by the National Cancer Institute of Canada-Clinical Trials Group to evaluate the efficacy and toxicity of two doses of oral gefitinib in patients with minimally symptomatic , hormone-refractory prostate cancer ( HRPC ) .
METHODS	Between July and November 2001 , 40 patients with HRPC and increasing prostate-specific antigen ( PSA ) or progression in measurable disease who had not received prior chemotherapy were randomly assigned to 250 mg ( n = 19 ) or 500 mg ( n = 21 ) oral gefitinib daily continuously .
METHODS	The primary end points were PSA response rate and objective measurable response .
METHODS	Functional Assessment of Cancer Therapy Prostate Cancer Subscale ( FACT-P ) quality-of-life questionnaires were completed at baseline and during treatment .
RESULTS	None of the patients demonstrated a PSA or objective measurable response .
RESULTS	Five ( 14.3 % ) of 35 assessable patients had stable PSA ( one patient at 250 mg and four patients at 500 mg ) , and five patients ( 14.3 % ) had a best response of stable disease ( duration , 2.5 to 16.8 months ) .
RESULTS	No significant effect on the rate of increase in PSA was seen .
RESULTS	The most common drug-related nonhematologic toxicities observed were grade 1 to 2 diarrhea ( 250 mg , 65 % ; 500 mg , 56 % ) , fatigue ( 250 mg , 29 % ; 500 mg , 33 % ) , and grade 1 to 2 skin rash ( 250 mg , 24 % ; 500 mg , 39 % ) .
RESULTS	FACT-P scores decreased during treatment , indicating worsening of symptoms compared with baseline .
CONCLUSIONS	Gefitinib did not result in any responses in PSA or objective measurable disease at either dose level .
CONCLUSIONS	Gefitinib has minimal single-agent activity in HRPC .

###18645518
OBJECTIVE	To evaluate the feasibility , fidelity , and effectiveness of a human immunodeficiency virus ( HIV ) prevention intervention delivered to HIV-infected patients by counselors during routine clinical care in KwaZulu-Natal , South Africa .
METHODS	A total of 152 HIV-infected patients , aged 18 years and older , receiving clinical care at an urban hospital in South Africa , were randomly assigned to intervention or standard-of-care control counselors .
METHODS	Intervention counselors implemented a brief risk reduction intervention at each clinical encounter to help patients reduce their unprotected sexual behavior .
METHODS	Self-report questionnaires were administered at baseline and 6 months to assess number of unprotected sex events in previous 3 months .
RESULTS	Intervention was delivered in 99 % of routine patient visits and included a modal 8 of 8 intervention steps .
RESULTS	Although HIV-infected patients in both conditions reported more vaginal and anal sex events at 6-month follow-up than at baseline , patients who received the counselor-delivered intervention reported a significant decrease over time in number of unprotected sexual events .
RESULTS	There was a marginally significant increase in these events among patients in the standard-of-care control condition .
CONCLUSIONS	A counselor-delivered HIV prevention intervention targeting HIV-infected patients seems to be feasible to implement with fidelity in the South African clinical care setting and effective at reducing unprotected sexual behavior .

###19910624
BACKGROUND	There have been recent studies suggesting that patients anesthetized with propofol have less postoperative pain compared with patients anesthetized with volatile anesthetics .
METHODS	In this randomized , double-blind study , 80 patients undergoing day-case diagnostic laparoscopic gynecological surgery were either anesthetized with IV propofol or sevoflurane .
METHODS	The primary outcome measured was pain on a visual analog scale .
RESULTS	Patients anesthetized with propofol had less pain compared with patients anesthetized with sevoflurane ( P = 0.01 ) .
RESULTS	There was no difference in any of the other measured clinical outcomes .
CONCLUSIONS	The patients anesthetized with propofol appeared to have less pain than patients anesthetized with sevoflurane .

###18348597
OBJECTIVE	The aim of the study was to evaluate possible new treatments for major depressive disorder in patients with comorbid alcohol dependence in a municipal alcohol treatment unit .
OBJECTIVE	The efficacy of memantine , a noncompetitive glutamate N-methyl-D-aspartate ( NMDA ) - receptor blocker used for the treatment of moderate to severe Alzheimer 's disease , was compared with that of escitalopram , a selective serotonin reuptake inhibitor antidepressant .
METHODS	Eighty alcohol-dependent outpatients with major depressive disorder ( DSM-IV criteria ) seeking treatment from municipal alcohol treatment clinics in Helsinki , Finland , were randomly assigned 1:1 to receive memantine 20 mg/day or escitalopram 20 mg/day .
METHODS	During the study period , patients continued their routine treatment at the clinics .
METHODS	Abstinence was not required .
METHODS	Concomitant interventions or imposed treatment goals were not offered by the study physician .
METHODS	The patients returned to the treatment clinics at weeks 1 , 2 , 4 , 12 , and 26 for data collection and for medication checking and dispensing .
METHODS	Outcome measures were the Montgomery-Asberg Depression Rating Scale ( MADRS ) and Beck Depression Inventory-II for depression , Hamilton Rating Scale for Anxiety ( HAM-A ) and Beck Anxiety Inventory for anxiety , Consortium to Establish a Registry for Alzheimer 's Disease test battery for cognitive functions , and Social and Occupational Functioning Assessment Scale for social and occupational functions and quality-of-life measures .
METHODS	Twenty-nine patients in each group completed the study .
METHODS	All primary and secondary outcome statistical analyses were performed by an independent source for intent-to-treat populations , which included all patients randomly assigned to treatment .
METHODS	The study was conducted from December 2004 to May 2006 .
RESULTS	Both treatments significantly reduced the baseline level of depression and anxiety according to MADRS and HAM-A , which were the primary measures ( p < .0001 ) .
RESULTS	There was no significant difference between the memantine and escitalopram groups .
RESULTS	Assessed cognitive functioning scores were primarily within the normative range and were unchanged in both groups .
RESULTS	Quality-of-life outcomes equally improved in both treatment groups .
CONCLUSIONS	These data provide new evidence for the safety and potential efficacy of memantine and escitalopram for major depressive disorder in patients with comorbid alcohol dependence .
BACKGROUND	ClinicalTrials.gov identifier NCT00368862 .

###7986437
OBJECTIVE	To clinically evaluate a resin composite .
METHODS	Sixty restorations were inserted at a ratio of 1:3 in Class I and II preparations in molars .
METHODS	Caulk Prisma AP.H / Prisma Universal Bond resin composite restorative system was placed .
METHODS	All the restorations were evaluated using the USPHS system and M-L indirect scale ; 6 , 12 , 24 and 36 month recalls were compared to baseline .
RESULTS	Color , interfacial staining , secondary caries , marginal integrity and surface texture ( Alfa = 89 % , 94 % , 97 % , and 100 % respectively ) were essentially unchanged from baseline for all restorations .
RESULTS	One restoration failed due to secondary caries .
RESULTS	Two were assessed with Charlie ( C ) ratings for marginal defects and one for wear .
RESULTS	Direct wear analysis ( Alfa = 12 % ) was significantly changed from the baseline .
RESULTS	Indirect mean estimated wear measurements for each recall period , adjusted for baseline , were 21 + / - 18 microns , 54 + / - 29 microns , 67 + / - 29 microns , and 98 + / - 43 microns respectively .
RESULTS	The wear of AP.H was characteristically linear ( g2 = 0.987 ) for composites whose mean filler particle size approaches 1 micron or less .

###22790513
OBJECTIVE	To establish the efficacy and safety of intravitreal bevacizumab ( Avastin ) with panretinal photocoagulation ( PRP ) followed by Ahmed valve implantation in the treatment of neovascular glaucoma ( NVG ) .
METHODS	This prospective randomized study included 40 eyes of 40 patients with refractory NVG .
METHODS	Twenty eyes underwent Ahmed valve implantation with intravitreal bevacizumab ( Avastin ) ( 1.25 mg in 0.5 mL ) and PRP and 20 eyes were managed by Ahmed valve and PRP ( control group ) .
METHODS	The follow-up period was 18 months .
RESULTS	Complete success was defined as an intraocular pressure 21 mm Hg .
RESULTS	Qualified success was considered when the above criteria were fulfilled but with additions of antiglaucoma topical medical treatment .
RESULTS	The results revealed 95 % total success ( 75 % complete success and 20 % qualified success ) in the first group in which Avastin-augmented Ahmed valve was performed compared with 50 % total success in the control group in which Ahmed valve implantation was performed alone ( 25 % complete success and 25 % qualified success ) .
CONCLUSIONS	Intravitreal bevacizumab ( Avastin ) with PRP followed by Ahmed valve implantation appears to be effective in the management of NVG .

###22767164
OBJECTIVE	To compare the refractive , visual acuity , topographic , and spherical aberration outcomes of LASIK using the Quest excimer laser platform with the optimized prolate ablation ( OPA ) profile ( NIDEK Co Ltd ) in one eye and conventional ablation profile in the fellow eye of the same patient .
METHODS	Thirty-seven myopic patients underwent LASIK bilaterally , with one eye randomized to receive OPA ablation ( -3.881.42 diopters [ D ] , range : -1.53 to -7.50 D ) and the fellow eye to receive conventional ablation ( -3.891.37 D , range : -1.75 to -7.00 D ) .
METHODS	Independent and paired t tests were used for testing differences between groups at last postoperative follow-up ( 6 or 12 months ) .
RESULTS	Postoperatively , 97 % ( 32/33 ) of OPA eyes and 94 % ( 31/33 ) of conventional eyes saw 20/20 or better without correction ( P > .05 ) .
RESULTS	No eyes lost 2 or more lines of distance corrected visual acuity .
RESULTS	Manifest refraction spherical equivalent was -0.16 D in the OPA group and -0.05 D in the conventional group ( P > .05 ) .
RESULTS	Ocular spherical aberration was -0.003 m in the OPA group and +0.102 m in the conventional group ( P < .05 ) .
RESULTS	Corneal asphericity was statistically lower after OPA ( 0.070.26 ) compared to conventional ablation ( 0.300.26 ) ( P < .001 ) .
RESULTS	The mean programmed optical zone and achieved postoperative horizontal diameter of the effective optical zone were statistically significantly larger in the OPA group ( P < .05 ) .
CONCLUSIONS	Postoperative visual acuity and refractive outcomes were similar between groups .
CONCLUSIONS	Laser in situ keratomileusis using the OPA profile for the correction of myopia induced significantly less corneal and ocular spherical aberration , resulted in normal postoperative asphericity in 94 % of eyes , and larger horizontal diameter of the effective optical zone compared to the conventional profile .

###16877482
BACKGROUND	Tacrolimus and ciclosporin might have different effects on intra-renal fibrosis and allograft function in chronic allograft nephropathy ( CAN ) .
BACKGROUND	It is difficult to predict the response to calcineurin inhibitor minimization in patients with CAN .
METHODS	This prospective randomized study compared ciclosporin A ( CsA ) - to-tacrolimus conversion ( group A , target tacrolimus trough level 6-8 ng/ml ) vs CsA minimization ( group B , target CsA trough level 80-100 ng/ml ) with regard to efficacy and safety in patients with CAN and deteriorating allograft function .
METHODS	The primary efficacy endpoint was improvement in the slope of inverse serum creatinine ( 1/SCr ) vs time plot .
RESULTS	There were 34 evaluable patients ( n = 16 in group A ; n = 18 in group B ) , with similar baseline characteristics .
RESULTS	Both groups reached target drug levels after a 3-month run-in period .
RESULTS	Over the ensuing 12 months , nine ( 56.3 % ) subjects in group A and 10 ( 55.6 % ) in group B reached the primary end point ( P = 0.968 ) .
RESULTS	Both groups showed considerable improvement in the slope of 1/SCr vs time plot .
RESULTS	There was no significant difference in the slope between groups before and after intervention .
RESULTS	Graft survival was 87 % in group A and 100 % in group B ( P = 0.121 ) .
RESULTS	Acute rejection was encountered in two group A subjects .
RESULTS	There was no significant change or difference in blood glucose , lipids , and blood pressure between groups .
CONCLUSIONS	Our results suggest that in patients with CAN and deteriorating allograft function , CsA-to-tacrolimus conversion or CsA minimization achieved comparable efficacies in retarding the decline of graft function .
CONCLUSIONS	Such contention may be biased by the low patient number .
CONCLUSIONS	Further studies with a larger cohort are needed for validation .

###21569343
BACKGROUND	The debate about a possible relationship between aerobic fitness and motor skills with cognitive development in children has recently re-emerged , because of the decrease in children 's aerobic fitness and the concomitant pressure of schools to enhance cognitive performance .
BACKGROUND	As the literature in young children is scarce , we examined the cross-sectional and longitudinal relationship of aerobic fitness and motor skills with spatial working memory and attention in preschool children .
METHODS	Data from 245 ethnically diverse preschool children ( mean age : 5.2 ( 0.6 ) years , girls : 49.4 % ) analyzed at baseline and 9 months later .
METHODS	Assessments included aerobic fitness ( 20 m shuttle run ) and motor skills with agility ( obstacle course ) and dynamic balance ( balance beam ) .
METHODS	Cognitive parameters included spatial working memory ( IDS ) and attention ( KHV-VK ) .
METHODS	All analyses were adjusted for age , sex , BMI , migration status , parental education , native language and linguistic region .
METHODS	Longitudinal analyses were additionally adjusted for the respective baseline value .
RESULTS	In the cross-sectional analysis , aerobic fitness was associated with better attention ( r = 0.16 , p = 0.03 ) .
RESULTS	A shorter time in the agility test was independently associated with a better performance both in working memory ( r = -0.17 , p = 0.01 ) and in attention ( r = -0.20 , p = 0.01 ) .
RESULTS	In the longitudinal analyses , baseline aerobic fitness was independently related to improvements in attention ( r = 0.16 , p = 0.03 ) , while baseline dynamic balance was associated with improvements in working memory ( r = 0.15 , p = 0.04 ) .
CONCLUSIONS	In young children , higher baseline aerobic fitness and motor skills were related to a better spatial working memory and/or attention at baseline , and to some extent also to their future improvements over the following 9 months .
BACKGROUND	clinicaltrials.gov NCT00674544 .

###20151839
BACKGROUND	The MERIT ( Maraviroc versus Efavirenz in Treatment-Naive Patients ) study compared maraviroc and efavirenz , both with zidovudine-lamivudine , in antiretroviral-naive patients with R5 human immunodeficiency virus type 1 ( HIV-1 ) infection .
METHODS	Patients screened for R5 HIV-1 were randomized to receive efavirenz ( 600 mg once daily ) or maraviroc ( 300 mg once or twice daily ) with zidovudine-lamivudine .
METHODS	Coprimary end points were proportions of patients with a viral load < 400 and < 50 copies/mL at week 48 ; the noninferiority of maraviroc was assessed .
RESULTS	The once-daily maraviroc arm was discontinued for not meeting prespecified noninferiority criteria .
RESULTS	In the primary 48-week analysis ( n = 721 ) , maraviroc was noninferior for < 400 copies/mL ( 70.6 % for maraviroc vs 73.1 % for efavirenz ) but not for < 50 copies/mL ( 65.3 % vs 69.3 % ) at a threshold of -10 % .
RESULTS	More maraviroc patients discontinued for lack of efficacy ( 11.9 % vs 4.2 % ) , but fewer discontinued for adverse events ( 4.2 % vs 13.6 % ) .
RESULTS	In a post hoc reanalysis excluding 107 patients ( 15 % ) with non-R5 screening virus by the current , more sensitive tropism assay , the lower bound of the 1-sided 97.5 % confidence interval for the difference between treatment groups was above -10 % for each end point .
CONCLUSIONS	Twice-daily maraviroc was not noninferior to efavirenz at < 50 copies/mL in the primary analysis .
CONCLUSIONS	However , 15 % of patients would have been ineligible for inclusion by a more sensitive screening assay .
CONCLUSIONS	Their retrospective exclusion resulted in similar response rates in both arms Trial registration .
CONCLUSIONS	ClinicalTrials.gov identifier : ( NCT00098293 ) .

###20832550
OBJECTIVE	To test in a prospective randomized study the hypothesis that use of thromboelastography ( TEG ) decreases blood transfusion during major surgery .
METHODS	Twenty-eight patients undergoing orthotopic liver transplantation were recruited over 2 years .
METHODS	Patients were randomized into 2 groups : those monitored during surgery using point-of-care TEG analysis , and those monitored using standard laboratory measures of blood coagulation .
METHODS	Specific trigger points for transfusion were established in each group .
RESULTS	In patients monitored via TEG , significantly less fresh-frozen plasma was used ( mean [ SD ] , 12.8 [ 7.0 ] units vs 21.5 [ 12.7 ] units ) .
RESULTS	There was a trend toward less blood loss in the TEG-monitored patients ; however , the difference was not significant .
RESULTS	There were no differences in total fluid administration and 3-year survival .
CONCLUSIONS	Thromboelastography-guided transfusion decreases transfusion of fresh - frozen plasma in patients undergoing orthotopic liver transplantation , but does not affect 3-year survival .

###16359953
OBJECTIVE	To evaluate the effect of degenerated ( lysed ) blastomere removal on implantation and pregnancy rates in cleavage-stage cryo-embryo transfer ( ET ) cycles .
METHODS	Randomized clinical trial .
METHODS	Private reproductive medical center .
METHODS	A total of 88 patients who received frozen-thawed ET , divided into two groups .
METHODS	Embryo freezing and thawing ; opening of the zona pellucida and removal of cryodamaged blastomeres ( in the study group ) , followed by same-day ET .
METHODS	Extent of survival of cleavage-stage embryos after the freeze-thaw procedure ; embryo implantation and clinical pregnancies .
RESULTS	Oocyte number per patient , fertilization rate , embryo development rate ( and quality ) , and freezing rates were similar in the two groups in the fresh cycle .
RESULTS	In the control group , a total of 55 embryos ( 25 % ) of the 217 thawed remained fully intact , and 53 ( 26 % ) of the 207 in the study group remained intact .
RESULTS	The average number of embryos transferred per group was similar ( control , 3.4 + / - 0.9 ; study , 3.3 + / - 0.9 ) .
RESULTS	Implantation rates were 12 % and 26 % in the control and study groups , respectively .
RESULTS	The clinical pregnancy rate was 23 % in the control group and 64 % in the study group when lysed cell removal was performed .
CONCLUSIONS	The results show that pregnancy and implantation rates are higher in the study group ; therefore , the removal of degenerated blastomeres may be beneficial to all patients who undergo cleavage-stage , frozen-thawed ET .

###22708881
BACKGROUND	Postcancer fatigue is a frequently occurring , severe , and invalidating problem , impairing quality of life .
BACKGROUND	Although it is possible to effectively treat postcancer fatigue with cognitive behaviour therapy , the nature of the underlying ( neuro ) physiology of postcancer fatigue remains unclear .
BACKGROUND	Physiological aspects of fatigue include peripheral fatigue , originating in muscle or the neuromuscular junction ; central fatigue , originating in nerves , spinal cord , and brain ; and physical deconditioning , resulting from a decreased cardiopulmonary function .
BACKGROUND	Studies on physiological aspects of postcancer fatigue mainly concentrate on deconditioning .
BACKGROUND	Peripheral and central fatigue and brain morphology and function have been studied for patients with fatigue in the context of chronic fatigue syndrome and neuromuscular diseases and show several characteristic differences with healthy controls .
METHODS	Fifty seven severely fatigued and 21 non-fatigued cancer survivors will be recruited from the Radboud University Nijmegen Medical Centre .
METHODS	Participants should have completed treatment of a malignant , solid tumour minimal one year earlier and should have no evidence of disease recurrence .
METHODS	Severely fatigued patients are randomly assigned to either the intervention condition ( cognitive behaviour therapy ) or the waiting list condition ( start cognitive behaviour therapy after 6 months ) .
METHODS	All participants are assessed at baseline and the severely fatigued patients also after 6 months follow-up ( at the end of cognitive behaviour therapy or waiting list ) .
METHODS	Primary outcome measures are fatigue severity , central and peripheral fatigue , brain morphology and function , and physical condition and activity .
CONCLUSIONS	This study will be the first randomized controlled trial that characterizes ( neuro ) physiological factors of fatigue in disease-free cancer survivors and evaluates to which extent these factors can be influenced by cognitive behaviour therapy .
CONCLUSIONS	The results of this study are not only essential for a theoretical understanding of this invalidating condition , but also for providing an objective biological marker for fatigue that could support the diagnosis and follow-up of treatment .
BACKGROUND	The study is registered at http://ClinicalTrials.gov ( NCT01096641 ) .

###18694405
OBJECTIVE	Peer-assisted learning ( PAL ) has been reported to have educational benefits in cross-year , small-group teaching in other contexts .
OBJECTIVE	Accordingly , we explored whether senior medical students are effective tutors for their junior peers in clinical skills education , and how the participants in the learning triad ( tutors , learners and simulated patients [ SPs ] ) perceive the learning environment created in PAL .
METHODS	Year 2 students were randomly allocated to one of two groups for skills training .
METHODS	Group 1 ( n = 64 ) were tutored by volunteer Year 6 students , and Group 2 ( n = 67 ) by paid doctors .
METHODS	The results of both groups in a clinical skills examination were compared using an independent samples t-test .
METHODS	Qualitative data , obtained from Year 2 students ( n = 125 ) by written questionnaire and Year 6 students ( n = 11 ) and SPs ( n = 3 ) by focus group interviews , were analysed for themes .
RESULTS	Students receiving PAL did at least as well in the clinical skills examination as students with qualified tutors ( difference in mean total score : 0.7 marks out of 112 ; 95 % confidence interval -- 8 to 2.4 ) .
RESULTS	The PAL environment was perceived as ` comfortable ' and fostered the development of confidence in all participants .
RESULTS	Peer tutors created a more active learning environment than doctor tutors for both learners and SPs and reported personal benefits from teaching .
CONCLUSIONS	With appropriate support , volunteer Year 6 student tutors are as effective as graduate doctors for small-group structured tutorials in clinical skills .
CONCLUSIONS	Educational relationships were forged between all participants in the learning triad .

###25173516
OBJECTIVE	Lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) has been hypothesized to be involved in atherogenesis through pathways related to inflammation .
OBJECTIVE	Darapladib is an oral , selective inhibitor of the Lp-PLA2 enzyme .
OBJECTIVE	To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome ( ACS ) event .
METHODS	SOLID-TIMI 52 was a multinational , double-blind , placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS ( non-ST-elevation or ST-elevation myocardial infarction [ MI ] ) at 868 sites in 36 countries .
METHODS	Patients were randomized to either once-daily darapladib ( 160 mg ) or placebo on a background of guideline-recommended therapy .
METHODS	Patients were followed up for a median of 2.5 years between December 7 , 2009 , and December 6 , 2013 .
METHODS	The primary end point ( major coronary events ) was the composite of coronary heart disease ( CHD ) death , MI , or urgent coronary revascularization for myocardial ischemia .
METHODS	Kaplan-Meier event rates are reported at 3 years .
RESULTS	During a median duration of 2.5 years , the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group ( 16.3 % vs 15.6 % at 3 years ; hazard ratio [ HR ] , 1.00 [ 95 % CI , 0.91-1 .09 ] ; P = .93 ) .
RESULTS	The composite of cardiovascular death , MI , or stroke occurred in 824 in the darapladib group and 838 in the placebo group ( 15.0 % vs 15.0 % at 3 years ; HR , 0.99 [ 95 % CI , 0.90-1 .09 ] ; P = .78 ) .
RESULTS	There were no differences between the treatment groups for additional secondary end points , for individual components of the primary end point , or in all-cause mortality ( 371 events in the darapladib group and 395 in the placebo group [ 7.3 % vs 7.1 % at 3 years ; HR , 0.94 [ 95 % CI , 0.82-1 .08 ] ; P = .40 ) .
RESULTS	Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group ( 11.5 % vs 2.5 % ) and also more likely to report diarrhea ( 10.6 % vs 5.6 % ) .
CONCLUSIONS	In patients who experienced an ACS event , direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events .
BACKGROUND	clinicaltrials.gov Identifier : NCT01000727 .

###20388196
BACKGROUND	There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior , and , in most of those studies , the target populations were primarily adults , whereas few focused on adolescents .
BACKGROUND	Essentially , there have been no randomized controlled studies comparing the efficacy , cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools .
BACKGROUND	There is also a lack of information on whether suicide-preventive interventions can , in addition to preventing suicide , reduce risk behaviors and promote healthier ones as well as improve young people 's mental health.The aim of the SEYLE project , which is funded by the European Union under the Seventh Framework Health Program , is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database ; testing , in a randomized controlled trial , three different suicide-preventive interventions ; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective ; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors .
METHODS	The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries : Austria , Estonia , France , Germany , Hungary , Ireland , Israel , Italy , Romania , Slovenia and Spain , with Sweden serving as the scientific coordinating center .
METHODS	Each country performs three active interventions and one minimal intervention as a control group .
METHODS	The active interventions include gatekeeper training ( QPR ) , awareness training on mental health promotion for adolescents , and screening for at-risk adolescents by health professionals .
METHODS	Structured questionnaires are utilized at baseline , 3 - and 12-month follow-ups in order to assess changes .
CONCLUSIONS	Although it has been reported that suicide-preventive interventions can be effective in decreasing suicidal behavior , well-documented and randomized studies are lacking .
CONCLUSIONS	The effects of such interventions in terms of combating unhealthy lifestyles in young people , which often characterize suicidal individuals , have never been reported .
CONCLUSIONS	We know that unhealthy and risk-taking behaviors are detrimental to individuals ' current and future health .
CONCLUSIONS	It is , therefore , crucial to test well-designed , longitudinal mental health-promoting and suicide-preventive interventions by evaluating the implications of such activities for reducing unhealthy and risk behaviors while concurrently promoting healthy ones .
BACKGROUND	The German Clinical Trials Register , DRKS00000214 .

###12461760
BACKGROUND	Disturbance of sleep is common in individuals with dementia where there may be reversal of the sleep-wake cycle .
BACKGROUND	People with dementia of the Alzheimer 's type have melatonin secretion rhythm disorders .
BACKGROUND	There is some evidence that treatment with exogenous melatonin is an effective treatment for sleep disturbance associated with dementia .
BACKGROUND	A randomised double blind placebo controlled cross over trial was undertaken to test the hypothesis that slow release exogenous melatonin 6 mg improves sleep for people with dementia .
METHODS	Forty-four participants with DSM-IV diagnoses of dementia with sleep disturbance were selected for a seven week randomised double blind cross over trial of slow release melatonin 6 mg versus placebo .
METHODS	Sleep parameters were objectively measured using wrist actigraphy .
RESULTS	Twenty-five out of 44 completed the trial .
RESULTS	Sleep was significantly disturbed in the sample population .
RESULTS	Melatonin had no effect on median total time asleep ( n = 25 , z = 1.35 , p = 0.18 ) , number of awakenings ( n = 25 , z = 0.32 , p = 0.75 ) or sleep efficiency ( n = 25 , z = 0.17 , p = 0.24 ) .
RESULTS	Nor were there any carry over effects from melatonin .
CONCLUSIONS	Contrary to previous findings , we found no evidence that two weeks of exogenous melatonin is effective in improving sleep in people with dementia , although possible benefits of melatonin following longer periods of administration can not be discounted .

###22040533
BACKGROUND	Combining maintenance medications with different mechanisms of action may improve outcomes in COPD .
BACKGROUND	In this study we evaluated the efficacy and safety of fluticasone/salmeterol ( FSC ) ( 250/50mcg twice daily ) when added to tiotropium ( 18mcg once daily ) ( TIO ) in subjects with symptomatic moderate to severe COPD .
METHODS	This was a 24-week , randomized , double-blind , parallel group , multi-center study .
METHODS	Subjects 40 years or older with cigarette smoking history 10 pack-years and with the diagnosis of COPD and post-bronchodilator FEV ( 1 ) 40 to 80 % of predicted normal and FEV ( 1 ) / FVC of 0.70 were enrolled .
METHODS	Following a 4-week treatment with open-label TIO 18mcg once daily , subjects were randomized in a double-blind fashion to either the addition of FSC 250/50 DISKUS twice daily or matching placebo .
METHODS	The primary efficacy endpoint was AM pre-dose FEV ( 1 ) and secondary endpoints included other measures of lung function , rescue albuterol use , health status and exacerbations .
RESULTS	The addition of FSC to TIO significantly improved lung function indices including AM pre-dose FEV ( 1 ) , 2h post-dose FEV ( 1 ) , AM pre-dose FVC , 2h post-dose FVC and AM pre-dose IC compared with TIO alone .
RESULTS	Furthermore , this combination was superior to TIO alone in reducing rescue albuterol use .
RESULTS	However , there were no significant differences between the treatment groups in health status or COPD exacerbations .
RESULTS	The incidence of adverse events was similar in both groups .
CONCLUSIONS	The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events .
CONCLUSIONS	NCT00784550 .

###1573749
OBJECTIVE	To evaluate children who take theophylline for the presence of behavioral side effects and to determine whether the beliefs about these side effects held by their parents are supported by their own observations .
METHODS	A double-blind , placebo-controlled , randomized , crossover protocol .
METHODS	Under both study conditions the children completed tests that measured their attention , impulsivity , memory , activity level , and mood , while the parents rated their behavior .
METHODS	The subjects were 8 - to 12-year-old children with asthma whose parents had observed adverse behavioral side effects while the children were taking theophylline .
METHODS	Among cited side effects were impulsivity , hyperactivity , altered mood , and impaired attention .
RESULTS	No differences related to treatment could be detected from the parent questionnaires or from six of nine scores of the psychological evaluation of the children .
RESULTS	The children , however , made fewer attention errors and showed a mild increase in anxiety and hand tremor of the dominant hand while they were receiving theophylline .
RESULTS	All mean changes were small .
RESULTS	No significant relationship was found between theophylline concentrations in the serum and degree of change in mood or attention .
RESULTS	Eleven of 42 participants were disqualified for noncompliance during the study .
CONCLUSIONS	Parental beliefs about the side effects experienced by their children are not supported by their own observations performed through a blinded protocol .
CONCLUSIONS	These results are in conflict with reports of a high incidence of adverse behavioral side effects attributed to theophylline therapy .

###15472853
BACKGROUND	Concern about accidental contact transmission after smallpox vaccination has prompted various recommendations regarding vaccination site coverage .
METHODS	On days 6-8 after their first-ever smallpox vaccination , 63 adult subjects were randomized to apply a self-adhesive bandage ( n = 20 ) , gauze with adhesive tape ( n = 21 ) , or gauze with a semipermeable dressing ( n = 22 ) over the vaccination site for a mean of 8 + / -2 h. Swabs from the external bandage surfaces and the vaccination sites were then assessed by real time vaccinia-specific polymerase chain reaction ( PCR ) in blinded fashion .
RESULTS	Among 58 subjects completing the study , PCR results were positive for the vaccination site in 55 ( 94.8 % ) and on 10 swabs ( 17.2 % ) from external bandage surfaces .
RESULTS	There were no differences among the 3 bandages ( P = .57 ) .
CONCLUSIONS	At 7 days after smallpox vaccination , a peak time for vaccinia shedding , a self-adhesive bandage was as effective as 2 bulkier , less convenient bandages in limiting PCR-detectable virus on the external surface .

###17279301
OBJECTIVE	Colonoscopy is the `` gold standard '' for assessing colonic mucosal abnormalities .
OBJECTIVE	An important component of this is complete examination to the cecum .
OBJECTIVE	However , the ability to detect abnormalities is equally important and has received less attention .
OBJECTIVE	This study was designed to assess the accuracy of detection of artificial bowel markers as surrogates for small polyps .
METHODS	Patients were randomly assigned to receive between zero and four of each of two types of marker .
METHODS	Markers used were 5-mmx5-mm pieces of latex-free rubber or 12-mmx1 .5 - mm metallic bowel clips .
METHODS	These were placed on insertion of the colonoscope .
METHODS	At the limit of the colonoscopy , a second blinded endoscopist performed the extubation .
METHODS	Six endoscopists took part in the study .
METHODS	Data regarding the number , type , and position of the markers on insertion and withdrawal were recorded as were insertion and withdrawal times .
RESULTS	A total of 179 markers ( 85 clips , 94 rubbers ) were placed in 44 patients .
RESULTS	The cecal intubation rate was 91 percent .
RESULTS	Median intubation time was 20 minutes and withdrawal time was 15 minutes ; 139 markers ( 77.7 percent ) were detected on withdrawal ( clips , 76.5 percent ; rubbers , 78.7 percent ) .
RESULTS	There was no correlation between insertion or withdrawal times and marker detection .
RESULTS	Detection rates varied between endoscopists ( 71-87 percent ) , but there was no correlation with individual cecal intubation rates ( P = 0.96 ) .
RESULTS	Markers placed at flexures were missed more often ( P = 0.008 ) .
CONCLUSIONS	Artificial markers provide a novel method for assessing colonoscopic accuracy .
CONCLUSIONS	The results obtained with this method are closely concordant with results from other studies .
CONCLUSIONS	The technique is potentially useful in training , audit , and future research .

###22423669
OBJECTIVE	The prevalence of obesity and overweight among children and adolescents is increasing rapidly .
OBJECTIVE	The present research was performed to determine the influence of a '' behavior modification '' program on body mass index ( BMI ) in obese public high school students in Iran .
METHODS	In this study , 152 adolescence and their parents were selected from 12 high schools of Khorram Abad from 2004 to 2006 , and they were randomly assigned to either the intervention or the control groups .
METHODS	The `` behavior modification '' interventional program consisted of nutritional education , modifying dietary habits , teaching exercise programs , teaching nutritional facts to the parents , and performing exercises 3 days a week .
METHODS	The height and weight as well as waist , hip , and wrist circumferences of the participants were measured before and after implementing the interventional program .
METHODS	BMI and waist to hip ratio ( WHR ) were calculated .
METHODS	The adolescents and parents completed a nutrition knowledge questionnaire .
METHODS	Adolescents also completed the Beck 's Depression Questionnaire .
RESULTS	Adolescent 's mean weight , BMI , and waist and hip circumferences decreased significantly after implementing the interventional program , in the intervention group ( p0 .001 ) .
RESULTS	In addition , the students ' and parents ' nutrition knowledge increased in the intervention group after implementing the interventional program ( p < 0.046 ) .
RESULTS	The symptoms of depression decreased and the frequency of students without symptoms of depression increased in the case group , but it did not reveal a statistically significant difference between case and control groups .
CONCLUSIONS	The '' behavior modification '' interventional program is effective in reducing BMI in obese students , and therefore , school principals and planners can play an important role in controlling obesity by implementing this program via the students , their parents , and the school staff .

###9887897
OBJECTIVE	To evaluate the effect of Buteyko breathing techniques ( BBT ) in the management of asthma .
METHODS	Prospective , blinded , randomised study comparing the effect of BBT with control classes in 39 subjects with asthma .
METHODS	The study was conducted from January 1995 to April 1995 .
METHODS	Subjects recruited from the community , aged 12 to 70 years , with asthma and substantial medication use .
METHODS	Medication use ; morning peak expiratory flow ( PEF ) ; forced expiratory volume in one second ( FEV1 ) ; end-tidal ( ET ) CO2 ; resting minute volume ( MV ) ; and quality of life ( QOL ) score , measured at three months .
RESULTS	No change in daily PEF or FEV1 was noted in either group .
RESULTS	At three months , the BBT group had a median reduction in daily beta 2-agonist dose of 904 micrograms ( range , 29 micrograms to 3129 micrograms ) , whereas the control group had a median reduction of 57 micrograms ( range , -2343 micrograms to 1143 micrograms ) ( P = 0.002 ) .
RESULTS	Daily inhaled steroid dose fell 49 % ( range , -100 % to 150 % ) for the BBT group and 0 ( range , -82 % to +100 % ) for the control group ( P = 0.06 ) .
RESULTS	A trend towards greater improvement in QOL score was noted for BBT subjects ( P = 0.09 ) .
RESULTS	Initial MV was high and similar in both groups ; by three months , MV was lower in the BBT group than in the control group ( P = 0.004 ) .
RESULTS	ET CO2 was low in both groups and did not change with treatment .
CONCLUSIONS	Those practising BBT reduced hyperventilation and their use of beta 2-agonists .
CONCLUSIONS	A trend toward reduced inhaled steroid use and better quality of life was observed in these patients without objective changes in measures of airway calibre .

###10863252
OBJECTIVE	To evaluate the possible effect of the supine cervical rotary manipulation and the supine lateral break manipulation in the treatment of mechanical neck pain , according to subjective and objective clinical findings .
BACKGROUND	Delivering a supine lateral break manipulation to the ipsilateral side of an inflamed facet joint ( s ) that exhibits a lateral flexion fixation may result in pain and/or discomfort to the patient .
BACKGROUND	Thus the proposed alternative is a supine cervical rotary manipulation delivered on the ipsilateral side or a supine lateral break manipulation delivered on the contralateral side of the relevant joint ( s ) .
METHODS	Randomized , comparative clinical trial .
METHODS	Two groups of 15 subjects diagnosed with mechanical neck pain .
METHODS	The diagnosis of mechanical neck pain and the identification of lateral flexion fixations in the cervical spine were made with conventional clinical evaluation , including motion palpation .
METHODS	Group A received a cervical rotary manipulation ( s ) on the ipsilateral side of the lateral flexion fixation ( s ) , while group B received a supine lateral break manipulation ( s ) on the contralateral side of the lateral flexion fixation ( s ) .
METHODS	Subjects received a maximum of 10 treatments over a 4-week treatment period .
METHODS	Both treatment groups were assessed with subjective ( Numerical Pain Rating Scale 101 , McGill Short-Form Pain Questionnaire and the Canadian Memorial Chiropractic College Neck Disability Index ) and objective ( cervical range of motion goniometer and algometer ) measurement parameters at the initial consultation ( before any treatment ) , the final consultation , and at a 1-month follow-up consultation .
METHODS	Statistical analysis was conducted at a 95 % confidence level ( alpha = .05 ) with the non-parametric 2-tailed Wilcoxon signed ranks test , the Mann-Whitney U test , and descriptive statistics .
METHODS	Two-tailed power analysis was conducted after the fact , where a confidence level of 80 % ( beta = .20 ) was considered satisfactory .
RESULTS	Intragroup analysis indicated a significant difference between the initial consultation data and the final consultation data for the subjective data , indicating an effect .
RESULTS	Analysis of the objective data did not reveal any significant difference .
RESULTS	Intergroup analysis did not reveal any significant difference between the 2 groups when comparing the data of the initial consultation and the final consultation , indicating that both treatments had a similar or equal effect .
RESULTS	Power analysis was not satisfactory for most data , indicating the possibility of many Type II errors .
CONCLUSIONS	Statistically , the results suggested that both treatments had an effect but that neither group showed a benefit over the other .
CONCLUSIONS	However , because of the unsatisfactory power of the study , conclusions are to be drawn with caution .
CONCLUSIONS	Clinical significance supported the statistical outcomes where it was suggested that both treatments had an effect and that neither treatment had a greater effect .
CONCLUSIONS	A larger sample size and the inclusion of a placebo group is recommended to reveal true treatment outcomes and trends .

###17909514
BACKGROUND	Bonding agents could be used as fissure sealants .
BACKGROUND	This study compares the retention three fissure sealants ( Delton , Delton Plus and Concise ) and a filled dentin bonding system ( Optibond Solo ) .
BACKGROUND	METHODS .
BACKGROUND	Fifty-six children aged 7-8 years received fissure sealants either in the four permanent first molars , in the four deciduous second molars , or in all eight of these teeth .
BACKGROUND	Every child received a different sealing material in each quadrant on a random basis .
BACKGROUND	Clinical evaluation at 12 months was performed by a single blind examiner , and the retention was classified as either a success ( total retention ) or a failure ( partial retention or not present ) .
RESULTS	There were no statistically significant differences among the four materials in permanent maxillary molars or deciduous molars .
RESULTS	In permanent mandibular molars , Optibond Solo showed a lower percentage of retention ( 40.9 % ) , significantly different ( p = 0.002 ) to that of Delton ( 89.5 % ) , Delton Plus ( 87.5 % ) and Concise ( 76.5 % ) .
CONCLUSIONS	One bottle dentin bonding system used as a sealant does not improve the retention of conventional fissure sealants .
CONCLUSIONS	Because of the scarcity of studies on the use of dental adhesives as sealants , further studies are warranted for the final support of that conclusion .

###21623930
BACKGROUND	The relapsing nature of melasma emphasizes the need to maintain efficacy achieved after acute treatment .
OBJECTIVE	To compare clinical efficacy and safety of two 6-month Triple Combination ( TC ; containing fluocinolone acetonide , hydroquinone and tretinoin ) maintenance regimens in subjects with moderate to severe melasma , after daily treatment up to 8 weeks .
METHODS	This randomized , investigator-blinded , controlled study had a maintenance phase of 6 months .
METHODS	Sixteen centres in Brazil and Mexico enrolled 242 subjects 18 years or older attaining no or mild melasma after 8 weeks of daily TC applications .
METHODS	Subjects were randomized to receive TC in a twice weekly or tapering regimen [ 3/week ( 1st month ) , 2/week ( 2nd month ) , 1/week ( 4th month ) ] .
METHODS	Efficacy and safety measurements included median time to relapse and relapse-free rate , Global Severity Score , Melasma Area and Severity Index score ( MASI ) , subject 's assessment , quality of life questionnaire ( MelasQol ) , and adverse events .
RESULTS	The majority ( 78.8 % ) had no or mild melasma ( GSS 1 ) at week 8 and entered maintenance phase .
RESULTS	After 6 months , 53 % of patients remained relapse-free with improved quality of life , and time to relapse was similar between groups ( about 190 days ) .
RESULTS	Melasma severity at study entry , not maintenance baseline , influenced relapse rate .
RESULTS	The twice weekly regimen tended to show better effectiveness in postponing relapse in severe melasma .
RESULTS	Both regimens were safe .
CONCLUSIONS	After resolution of melasma with TC , maintenance therapy over 6 months was successful in preventing relapse in over half of the patients who entered maintenance phase .
CONCLUSIONS	Prescribing medicines should be adapted to patients based on melasma severity .

###17383643
OBJECTIVE	To evaluate the efficacy and safety of Adept ( 4 % icodextrin solution ) in reducing adhesions after laparoscopic gynecological surgery involving adhesiolysis .
METHODS	Multicenter , prospective , randomized , double-blind study comparing Adept with lactated Ringer 's solution ( LRS ) .
METHODS	Four hundred two patients randomized intraoperatively to Adept ( n = 203 ) or LRS ( n = 199 ) returned for second laparoscopy within 4-8 weeks .
METHODS	Incidence , severity , and extent of adhesions were determined on both occasions .
METHODS	The primary efficacy measure defined by the Food and Drug Administration was the number of patients achieving clinical success with adhesion treatment .
METHODS	Other measures included incidence and American Fertility Society ( AFS ) scores .
RESULTS	Significantly more Adept patients achieved clinical success than did LRS patients ( 49 % vs. 38 % ) .
RESULTS	In infertility patients , Adept demonstrated particular clinical success compared with LRS ( 55 % vs. 33 % ) .
RESULTS	This was reflected in the number of patients with a reduced AFS score ( 53 % vs. 30 % ) and in fewer patients with a moderate/severe AFS category score ( 43 % vs. 14 % ) .
RESULTS	Safety was comparable in both groups .
RESULTS	Most events were related to the surgery , with an increase in transient labial edema in the Adept group .
CONCLUSIONS	This is the first randomized , double-blind trial of an adhesion reduction agent .
CONCLUSIONS	It demonstrated that Adept is a safe and effective adhesion reduction agent in laparoscopy .

###9069692
OBJECTIVE	To develop and present a pharmaceutical care training program for pharmacists , and to examine the ability of these pharmacists to provide pharmaceutical care in a community pharmacy setting .
METHODS	Prospective , randomized study .
METHODS	A 40-hour pharmaceutical care training program was developed and presented to pharmacists , and 1,078 patients were randomly assigned to receive either ( 1 ) traditional pharmacy services or ( 2 ) pharmaceutical care , consisting of initial patient work-up and follow-up with documentation in a patient record .
METHODS	The study period was six months .
METHODS	Pharmacists documented problems identified , actions taken , and time required for all patients .
RESULTS	Pharmacists consistently identified and intervened to address problems in both study groups .
RESULTS	Patients receiving pharmaceutical care were more than seven times as likely to have any problems identified ( odds ratio [ OR ] 7.5 ; confidence interval [ CI ] 4.2-13 .1 ) , more than eight times as likely to have an intervention performed ( OR , 8.1 ; CI 4.7-14 .2 ) , and more than eight times as likely to have a drug-related problem identified ( OR 8.6 ; CI 4.8-15 .5 ) than were patients receiving traditional pharmacy services only .
RESULTS	Time spent counseling patients was similar for the two groups .
CONCLUSIONS	The training program proved to be an effective way to increase the number of problems identified and addressed by pharmacists .

###19284179
OBJECTIVE	To compare the effects of 800 mg of valerian with a placebo on sleep quality and symptom severity in people with restless legs syndrome ( RLS ) .
METHODS	A prospective , triple-blinded , randomized , placebo-controlled , parallel design was used to compare the efficacy of valerian with placebo on sleep quality and symptom severity in patients with RLS .
METHODS	Thirty-seven participants were randomly assigned to receive 800 mg of valerian or placebo for 8 weeks .
METHODS	The primary outcome of sleep was sleep quality with secondary outcomes including sleepiness and RLS symptom severity .
RESULTS	Data were collected at baseline and 8 weeks comparing use of valerian and placebo on sleep disturbances ( Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale ) and severity of RLS symptoms ( International RLS Symptom Severity Scale ) from 37 participants aged 36 to 65 years .
RESULTS	Both groups reported improvement in RLS symptom severity and sleep .
RESULTS	In a nested analysis comparing sleepy vs nonsleepy participants who received 800 mg ofvalerian ( n = 17 ) , significant differences before and after treatment were found in sleepiness ( P = .01 ) and RLS symptoms ( P = .02 ) .
RESULTS	A strong positive association between changes in sleepiness and RLS symptom severity was found ( P = .006 ) .
CONCLUSIONS	The results of this study suggest that the use of 800 mg of valerian for 8 weeks improves symptoms of RLS and decreases daytime sleepiness in patients that report an Epworth Sleepiness Scale ( ESS ) score of 10 or greater .
CONCLUSIONS	Valerian may be an alternative treatment for the symptom management ofRLS with positive health outcomes and improved quality of life .

###12006119
OBJECTIVE	To compare findings from two consecutive clinical trials of auricular acupuncture for cocaine addiction conducted at the same site in order to explore consistency of treatment effects .
METHODS	One hundred and sixty-five ( 165 ) cocaine-dependent , methadone-maintained patients ( study 1 , n = 82 ; study 2 , n = 83 ) .
METHODS	Subjects in both studies were randomly assigned to auricular acupuncture , a needle insertion control condition , or a no-needle relaxation control .
METHODS	Treatment sessions were offered five times weekly for 8 weeks .
METHODS	The two studies were equivalent in design , except that unlike study 1 , study 2 offered subject payments for attendance and did not include weekly group counseling .
METHODS	Cocaine use assessed by three times weekly urine screens constituted the primary outcome .
METHODS	Secondary measures included retention in treatment , treatment attendance , treatment credibility , therapeutic alliance , and acute effects of treatments .
RESULTS	Intent-to-treat analysis showed that patients assigned to acupuncture in study 1 , but not in study 2 , were significantly more likely to provide cocaine-negative urine samples relative to the two control conditions .
CONCLUSIONS	The positive effect for acupuncture found in study 1 was not found in study 2 .
CONCLUSIONS	Even though the two studies were similar , reasons for this inconsistency can not be determined definitively , but may be because of differences in psychosocial context and payment contingencies between the two studies , or the lack of effectiveness of acupuncture in this application .
CONCLUSIONS	The need to critically consider the influence of treatment context and other potential moderating variables on outcome in order to draw conclusions regarding treatment effectiveness is discussed .

###23736793
BACKGROUND	Recently an articular cartilage repair has been given much attention in the orthopaedic field .
BACKGROUND	Cartilage regeneration capacity is very limited .
BACKGROUND	Optimal approach seems to be a delivery of natural growth factors .
BACKGROUND	Autologous platelet-rich plasma ( PRP ) contains proliferative and chemoattractant growth factors .
BACKGROUND	The objective of the present study was to determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function .
METHODS	Fifty consecutive and strictly selected patients , affected by Grade II or III chondromalatia , underwent 1year treatment ( 9 injections ) with autologous PRP in a liquid form with 2.0 to 2.5-fold platelets concentration .
METHODS	Outcome measures included the Lysholm , Tegner , IKDC , and Cincinnati scores .
METHODS	Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration .
RESULTS	The study demonstrated significant improvement in Lysholm ( p < 0.05 ) , Tegner ( p < 0.05 ) , IKDC ( p < 0.05 ) , and Cincinnati ( p < 0.05 ) scores .
RESULTS	Results improved at 12-month follow-up .
RESULTS	Cartilage assessment revealed no significant cartilage regeneration ( p < 0.05 ) .
RESULTS	There were no adverse events reported .
CONCLUSIONS	PRP significantly reduced pain and improved quality of live in patients with low degree of cartilage degeneration .
CONCLUSIONS	Magnetic resonance imaging did not confirmed any significant cartilage condition improvement .

###15939850
BACKGROUND	Pulmonary infections can be life threatening for children with neuromuscular diseases who have impaired ability to clear secretions .
BACKGROUND	Intrapulmonary percussive ventilation ( IPV ) is a pneumatic device that delivers air and aerosol to the lungs at frequencies of 200 to 300 cycles per minute at peak pressures from 20 to 40 cm H ( 2 ) O. Anecdotal reports and pilot studies show its safety and effectiveness in mobilizing secretions in patients with cystic fibrosis .
OBJECTIVE	To test the hypothesis that IPV used in a pulmonary program for adolescents with neuromuscular disease would reduce the number of days of antibiotic use for pulmonary infection .
METHODS	A randomized , controlled study was conducted to compare efficacy of IPV with incentive spirometry ( IS ) in reducing number of days of antibiotic use in adolescents with neuromuscular disease .
METHODS	The secondary endpoints were the number of respiratory infections , hospitalizations , and school days missed .
RESULTS	A total of 18 patients were enrolled ( 9 IPV , 9 IS ) .
RESULTS	Antibiotic use was significantly higher with IS ( 24/1000 patient-days ) compared with IPV ( 0/1000 patient-days ) , ( incidence rate ratio , 43 ; 95 % confidence interval , 6-333 ) .
RESULTS	The IS group spent more days hospitalized ( 4.4 / 1000 patient-days vs 0/1000 patient-days ) than the IPV group ( incidence rate ratio , 8.5 ; 95 % confidence interval , 1.1-67 ) .
RESULTS	The IPV group had 0 episodes of pneumonia or bacterial bronchitis compared with 3 events in the IS group , although this did not meet statistical significance .
CONCLUSIONS	Intrapulmonary percussive ventilation as part of a preventive pulmonary regimen reduced days of antibiotic use and hospitalization for respiratory illness in adolescents with neuromuscular disease .

###12222700
OBJECTIVE	To determine whether statin therapy initiated early in acute myocardial infarction together with thrombolytic therapy in patients with acute myocardial infarction results in clinical benefit through early plaque stabilization .
RESULTS	The study population consisted of 77 patients who underwent coronary balloon angioplasty of the infarct-related artery during the first month of acute myocardial infarction .
RESULTS	These patients belonged to the cohort of the Pravastatin Turkish Trial ( PTT ) .
RESULTS	Forty of them were assigned randomly to have immediate pravastatin ( 40 mg/day ) therapy adjunctive to thrombolytic therapy regardless of serum lipid levels and received statin treatment throughout the study .
RESULTS	Lipid levels were determined immediately after admission and before angioplasty and at the end of 6 months .
RESULTS	Patients were re-evaluated clinically and angiographically for cardiovascular adverse events and restenosis after a 6-month follow-up period .
RESULTS	The baseline angiographic and clinical characteristics of the two groups were similar .
RESULTS	The incidence of angina was significantly lower in the pravastatin group ( 30.0 % , 12 patients ) compared to the control group ( 59.5 % , 22 patients ) ( p = 0.018 ) .
RESULTS	The cumulative major adverse cardiac events in the pravastatin group were significantly lower when compared to the control group ( 32.5 % vs. 75.6 % , p = 0.0001 ) .
CONCLUSIONS	Early initiation of pravastatin therapy immediately after an acute myocardial infarction significantly decreased the frequency of major cardiac adverse events .
CONCLUSIONS	Such early potential clinical benefits further strengthen the rationale for starting statin treatment as soon as possible after acute coronary events particularly in patients in whom invasive intervention is planned .

###23886804
OBJECTIVE	Preservation of voice , swallowing and airway is mandatory in early to moderately advanced supraglottic cancers .
OBJECTIVE	Here , we propose an endoscopic laryngoplasty to improve swallowing recovery in patients treated by extended CO laser supraglottic laryngectomy .
METHODS	We describe a new mucosal flap reconstruction technique in a cohort of seven laryngeal cancer patients with posterior extension , treated by CO laser resection .
METHODS	Clinical endoscopic and videofluoroscopy postoperative exams were performed , and swallow function was tested by the MD Anderson Dysphagia Inventory ( MDADI ) questionnaire .
RESULTS	No early complications were observed .
RESULTS	Absence of aspiration after two days in all cases was confirmed , and MDADI mean value result was 98 .
CONCLUSIONS	We suggest the harvest of a hypopharyngeal mucosal flap in all patients who require a laryngeal supraglottic posterior resection , with or without arytenoidectomy .

###15329583
BACKGROUND	Automatic control of depth of hypnosis using the Bispectral Index ( BIS ) can help to reduce phases of inadequate control .
BACKGROUND	Automated BIS control with propofol or isoflurane administration via an infusion system has recently been described , a comparable study with isoflurane administration via a vaporizer had not been conducted yet .
BACKGROUND	Our hypothesis was that our new model based closed-loop control system can safely be applied clinically and maintains the BIS within a defined target range better than manual control .
METHODS	Twenty-three patients , American Society of Anesthesiologists risk class I-III , scheduled for decompressive spinal surgery were randomized into groups with either closed-loop or manual control of BIS using isoflurane .
METHODS	An alfentanil target-controlled infusion was adjusted according to standard clinical practice .
METHODS	The BIS target was set to 50 during the operation .
METHODS	The necessity of human intervention in the control system and events of inadequate sedation ( BIS < 40 or BIS > 60 ) were counted .
METHODS	The number of phases of inadequate control , defined as BIS > / = 65 for more than 3 min , were recorded .
METHODS	The performance of the controller was assessed by several indicators ( mean absolute deviation and median absolute performance error ) and measured during the skin incision phase , the subsequent low flow phase , and the wound closure phase .
METHODS	Recovery profiles of both groups were compared .
RESULTS	No human intervention was necessary in the closed-loop control group .
RESULTS	The occurrence of inadequate BIS was quantified with the mean and median values of the area under the curve and amounted to 0.360 and 0.088 for the manual control group and 0.049 and 0.017 for the closed-loop control group , respectively .
RESULTS	In the manual control group nine phases of inadequate control were recorded , compared with one in the closed-loop control group , 10.3 % to 0.5 % of all observed anesthesia time .
RESULTS	During all phases the averages of the performance parameters ( mean absolute deviation and median absolute performance error ) were more than 30 % smaller in closed-loop control than in manual control ( P < 0.05 between groups ) .
CONCLUSIONS	Closed-loop control with BIS using isoflurane can safely be applied clinically and performs significantly better than manual control , even in phases with abrupt changes of stimulation that can not be foreseen by the control system .

###10323055
OBJECTIVE	To compare the effects of bedtime NPH Insulin vs Metformin combined with Glibenclamide in patients who are obese and had secondary failure to sulphonylurea treatment .
METHODS	Prospective , randomized , comparative study of patients having type-II diabetes , without complications with associated obesity and secondary failure to sulphonylureas .
METHODS	Thirty-six obese patients who continued to have blood glucose values of fasting > 150 mg/dl and/or random > 220 mg/dl , after 8 weeks of intensive dietary and drug therapy .
METHODS	For the 20 weeks of study , the patients were randomised in two equal groups , one receiving 20 to 40 units of NPH Insulin at bed time and the second group , Metformin upto a maximum dose of 3 grams , along with Sulphonylureas .
RESULTS	Both the groups showed , a significant reduction in the blood glucose values , with an average decrease of 50 mg/dl .
RESULTS	The other monitored parameters , such as , serum cholesterol , triglycerides and blood pressure values , also demonstrated a similar downwards trend .
RESULTS	However , the drop out rate was high in the Insulin treated group and the remainder group did show slight increase in weight and BMI , while the reverse , stood true , for the metformin group , with 100 % compliance rate .
CONCLUSIONS	Metformin , in obese , type II diabetics , with secondary failure to Sulphonylureas , is an effective , safe and well tolerated treatment , which not only improves the metabolic control but also favourably modifies other parameters such as weight , total cholesterol and triglyceride values .

###17242626
OBJECTIVE	The present study examined sleep-related problems ( SRPs ) among a large sample ( n = 128 ) of youth with anxiety disorders ( i.e. , generalized , separation , and social ) .
OBJECTIVE	The frequency of eight specific SRPs was examined in relation to age , gender , type of anxiety disorder , anxiety severity , and functional impairment .
OBJECTIVE	The impact of pharmacological treatment ( fluvoxamine versus pill placebo ) in reducing SRPs also was examined .
METHODS	As part of a large , double-blind , randomized , controlled trial ( Research Units on Pediatric Psychopharmacology Anxiety Study Group ) , clinician and parent reports of SRPs were examined among children and adolescents , ages 6 to 17 years , before and after treatment .
RESULTS	Eighty-eight percent of youth experienced at least one SRP , and a majority ( 55 % ) experienced three or more .
RESULTS	Total SRPs were positively associated with anxiety severity and interference in family functioning .
RESULTS	Significantly greater reductions in SRPs were found among children treated with fluvoxamine compared with placebo .
CONCLUSIONS	These findings indicate that SRPs are commonly associated with childhood anxiety disorders and suggest a need for the assessment of and attention to these problems in research and clinical settings .

###15614029
BACKGROUND	Reduced beta-adrenergic sensitivity has been reported in black subjects .
BACKGROUND	We hypothesized that beta-adrenergic stimulation by isoproterenol would affect pulse wave velocity ( PWV ) , a marker of arterial stiffness , differently in black and white subjects .
METHODS	Healthy normotensive black subjects ( n = 21 ) matched for age , gender , height and body mass index with healthy normotensive white subjects ( n = 20 ) , participated in a randomized , double-blind , placebo-controlled cross-over study .
METHODS	The PWV was determined using an automated device at baseline and after 30 min of an equal volume infusion of isoproterenol ( 8 mug/kg per min ) or placebo ( dextrose 5 % ) , separated by a washout period of 25 min .
RESULTS	At baseline , heart rate ( HR ) , systolic and diastolic blood pressure ( SBP , DBP ) and PWV were comparable in black and in white subjects .
RESULTS	Placebo had no significant effect on haemodynamic variables .
RESULTS	Isoproterenol increased HR , SBP and pulse pressure and decreased DBP with a comparable magnitude in both groups .
RESULTS	Compared with placebo , isoproterenol decreased carotid-femoral PWV in white ( from 5.9 + / - 1.2 to 5.7 + / - 1.1 m/s , means + / - SD , P = 0.05 ) , but not in black subjects ( from 6.2 + / - 1.3 to 6.6 + / - 1.7 m/s , P = 0.1 ) .
RESULTS	The difference in response between black and white subjects was significant ( P = 0.04 ) .
RESULTS	Isoproterenol decreased carotid-radial PWV only significantly in white subjects .
CONCLUSIONS	These results are compatible with the hypothesis of an altered beta-adrenergic sensitivity , which is expressed by a blunted effect of isoproterenol on arterial stiffness in black subjects .

###9219402
BACKGROUND	Sore throat is a common symptom presented to general practitioners ( GPs ) , and there remains controversy about the appropriate use of antibiotics .
OBJECTIVE	To compare , in a randomized controlled trial , the effectiveness of penicillin , cefixime and placebo on symptom resolution in patients presenting with a sore throat in general practice .
METHODS	Twenty-two GPs in Avon recruited 154 patients , aged 16-60 years , presenting to their GP with a sore throat , and for whom the GP would normally prescribe an antibiotic .
METHODS	Patients were randomized to one of three groups : penicillin V 250 mg four times a day ; cefixime 200 mg daily ; and placebo .
METHODS	Each was prescribed for five days .
METHODS	The main outcome measures were a diary of symptom resolution over seven days and eradication of group A beta-haemolytic streptococcus ( GABHS ) .
RESULTS	Of the 103 ( 67 % ) patients who completed symptom diaries , 40 were allocated to receive penicillin , 29 cefixime and 34 placebo .
RESULTS	In the analysis including all patients , symptom resolution was greater by day 3 in the cefixime group than in the placebo group .
RESULTS	Penicillin did not improve symptom resolution by day 3 compared with placebo , and cefixime was not statistically significantly different from penicillin .
RESULTS	There were significant differences in the proportion of patients using analgesia at day 3 , with the proportion being lowest in the cefixime group .
RESULTS	The results for the subgroup of patients without GABHS were similar to those for all patients ; in particular , the only statistically significant difference was between cefixime and placebo .
RESULTS	Although numbers were too small for statistical significance , among patients with GABHS the effects of penicillin and cefixime were similarly raised in relation to placebo .
CONCLUSIONS	Compared with placebo , cefixime can improve the rate of resolution of symptoms in patients with a sore throat who are selected for antibiotic treatment by their GP .
CONCLUSIONS	The unexpected finding that cefixime was of benefit compared with placebo for patients without GABHS suggests that bacteria other than GABHS may be important in the pathogenesis of sore throat .

###10714845
BACKGROUND	Sevoflurane , with its low pungency and low blood and tissue solubility , is an attractive anaesthetic in paediatric outpatient surgery .
BACKGROUND	Propofol-anaesthesia is recognised for its rapid and clear-headed emergence .
BACKGROUND	This study was designed to compare emergence and recovery characteristics of sevoflurane and propofol anaesthesia for tonsillectomy in children .
METHODS	Children aged 3-10 years , undergoing elective tonsillectomy , were randomly assigned to receive propofol ( n = 25 , induction with 3 mg x kg ( -1 ) , maintenance with 100-250 microg x kg ( -1 ) min ( -1 ) ) or sevoflurane anaesthesia ( n = 25 , induction 7 vol .
METHODS	% , maintenance 2-3 vol .
METHODS	% ) .
METHODS	Tracheal intubation was performed with alfentanil 20 microg x kg ( -1 ) and atracurium 0.5 mg x kg ( -1 ) .
METHODS	Ventilation was controlled to maintain normocapnia and all patients received N2O/O2 ( 60:40 vol .
METHODS	% ) for induction and maintenance of anaesthesia .
METHODS	At the end of surgery infiltration of the operative sites with bupivacaine 2 mg x kg ( -1 ) was provided for postoperative analgesia .
METHODS	Emergence , recovery , discharge times , and incidence of side effects were compared between the two groups .
RESULTS	Time to extubation ( 14 vs 15 min ) , time to response to simple verbal command ( 21 vs 21 min ) and time to discharge from the recovery room ( 45 vs 50 min ) were similar in the sevoflurane and propofol groups , respectively .
RESULTS	There was a significantly greater incidence of postoperative agitation in the sevoflurane group ( 46 % ) compared with the propofol group ( 9 % ) ( P = 0.008 ) .
RESULTS	This did not , however , delay discharge from the recovery room .
RESULTS	The incidence of nausea and vomiting was not significantly different ( 8 % vs 0 % ; P = 0.49 ) .
CONCLUSIONS	In children , recovery from anaesthesia with sevoflurane results in a higher incidence of agitation compared with propofol .

###19393999
OBJECTIVE	To evaluate the role of hyaluronic acid ( HA ) for sperm selection before intracytoplasmic sperm injection ( ICSI ) .
METHODS	Three prospective studies .
METHODS	Private assisted reproduction center in Italy .
METHODS	Study 1 : 20 men .
METHODS	Study 2 : 15 men .
METHODS	Study 3 : 206 couples treated with ICSI on a limited number of oocytes per patient ( 1-3 ) in accordance with Italian IVF law .
METHODS	Study 1 : determination of sperm DNA fragmentation of HA-bound spermatozoa versus spermatozoa in polyvinylpyrrolidone ( PVP ) .
METHODS	Study 2 : assessment of nuclear morphology of HA-bound spermatozoa versus spermatozoa in PVP .
METHODS	Study 3 : randomized study comparing conventional PVP-ICSI to ICSI in which the spermatozoa are selected for their capacity to bind to HA ( HA-ICSI ) .
METHODS	Study 1 : sperm DNA fragmentation rate .
METHODS	Study 2 : sperm nucleus normalcy rate according to motile sperm organellar morphology examination criteria .
METHODS	Study 3 : fertilization , embryo quality and development , and implantation and pregnancy .
RESULTS	Spematozoa bound to HA show a significant reduction in DNA fragmentation ( study 1 ) and a significant improvement in nucleus normalcy ( study 2 ) compared with spermatozoa immersed in PVP .
RESULTS	Furthermore , injection of HA-bound spermatozoa ( HA-ICSI ) significantly improves embryo quality and development ( study 3 ) .
CONCLUSIONS	Hyaluronic acid may optimize ICSI outcome by favoring selection of spermatozoa without DNA fragmentation and with normal nucleus .
CONCLUSIONS	Furthermore , HA may also be used to speed up the selection of spermatozoa with normal nucleus during intracytoplasmic morphologically selected sperm injection ( IMSI ) .

###12447222
BACKGROUND	Residual provisional cement and debris on prepared teeth may have the potential to negatively influence the performance of the definitive luting agent .
OBJECTIVE	This in vivo study quantified the adherence of provisional cement to abutment teeth prepared with 1 of 2 textures ( coarse or fine ) and cleaned with 1 of 3 common cleansing techniques .
METHODS	One hundred ten provisional restorations in 22 patients were luted to maxillary anterior abutment teeth .
METHODS	The teeth were prepared for complete veneer restorations with either a coarse-grit diamond bur or a coarse-grit diamond bur followed by a fine-grit diamond bur .
METHODS	After removal of the restoration , abutment teeth were randomly cleansed with either a No. 23 dental explorer and air-water spray , a prophy cup with fine flour pumice , or a cotton pellet soaked in chlorhexidine gluconate , 0.12 % .
METHODS	After the abutments were cleansed , they were evaluated intraorally under a light microscope ( magnification , x64 ) by 2 blinded examiners .
METHODS	The teeth were given scores based on the number of specks of residual cement found on the surface after the cleansing techniques were performed .
METHODS	Pearson correlation coefficients ( alpha = .96 ) , 3-way analysis of variance , and post hoc Scheff tests ( P < .05 ) were used to analyze the data .
RESULTS	As determined with Pearson correlation coefficient , the interexaminer reliability was alpha = .96 .
RESULTS	Three-way analysis of variance revealed significant effects for the cleansing techniques but not for the interaction between cleansing techniques and preparation texture .
RESULTS	A post hoc Scheff test showed that the pumice cleansing technique ( 1.8 specks/tooth ) was significantly better than the explorer or the cotton pellet/chlorhexidine gluconate technique ( 3.6 and 3.5 specks/tooth , respectively ) ( P < .05 ) .
CONCLUSIONS	Within the limitations of this study , abutment teeth cleansed with a prophy cup and flour pumice exhibited the least amount of residual provisional cement .

###16942934
BACKGROUND	Ghrelin is a gut-brain hormone , which stimulates food intake and controls energy balance .
BACKGROUND	Recently , it has been shown that ghrelin may also play a role in the regulation of blood pressure ( BP ) by acting at the sympathetic nervous system .
BACKGROUND	In the present study we genotyped six variants of the ghrelin gene and its promoter , and tested whether these single nucleotide polymorphisms ( SNPs ) were associated with BP levels in participants of the Finnish Diabetes Prevention Study .
METHODS	The Finnish Diabetes Prevention Study was a longitudinal study where 522 subjects with impaired glucose tolerance were randomized into either an intervention or control group .
METHODS	DNA was available from 507 subjects ( mean body mass index [ BMI ] 31.2 + / -4.5 kg/m2 , age 55 + / -7 years ) .
METHODS	All six SNPs were screened by the restriction fragment length polymorphism method .
RESULTS	Subjects with the most common genotype combination of the following four SNPs , -604 G/A , -501 A/C , Leu72Met , and Gln90Leu , had the lowest systolic ( 131 + / -11 v 137 + / -13 mm Hg , P = .003 ) and diastolic BP levels ( 79 + / -7 v 83 + / -7 mm Hg , P = .004 ) at the baseline of the study and during 3 years of follow-up compared to all other genotypes .
RESULTS	Adjustments for age , gender , antihypertensive medication , BMI , waist circumference , and alcohol intake did not change this association .
CONCLUSIONS	Several ghrelin gene variations were associated with BP levels in subjects with impaired glucose tolerance .

###18158695
OBJECTIVE	Magnetic resonance imaging of the small bowel with an oral contrast ( MRI per os ) is believed to generate fewer adverse symptoms compared with installation of the contrast in a nasojejunal catheter ( MRE ) .
OBJECTIVE	However , there is very little evidence to support this assumption .
OBJECTIVE	The aim of this study was to evaluate the compliance of patients examined with both of these MRI methods .
METHODS	Patients with suspected or known Crohn 's disease referred for MRI of the small bowel underwent both MRI per os and MRE within 7 days .
METHODS	A questionnaire was answered immediately and 24 h after the procedure .
METHODS	Adverse symptoms were graded on a visual analogue scale ( VAS ) .
METHODS	Responses were compared with paired and independent sample t-tests and signed-rank tests .
METHODS	Correlation of each symptom to the overall discomfort was evaluated with Spearman 's correlation coefficient .
RESULTS	Thirty-eight patients ( 18 F , 20 M ) were included in the analysis .
RESULTS	Abdominal pain and discomfort were lower with MRI per os than with MRE ( mean VAS pain score immediately after : 10 mm and 33 mm , respectively , p < 0.001 ; mean VAS discomfort score 24 h after : 18 mm and 62 mm , respectively , p < 0.001 ) .
RESULTS	Nausea and abdominal pain were correlated with overall discomfort after MRI per os ( r = 0.56 for both , p < 0.001 ) .
RESULTS	No symptoms were significantly correlated with discomfort experienced with MRE .
RESULTS	More patients accepted repeat MRI per os examination ( n = 36 ) than MRE ( n = 22 , p = 0.001 ) .
CONCLUSIONS	Patients preferred and experienced less abdominal pain and discomfort with MRI per os than with MRE .

###23394705
OBJECTIVE	We conducted a prospective , randomized , open-label , multicenter study to compare busulfan plus fludarabine ( BuFlu ) with busulfan plus cyclophosphamide ( BuCy ) as the conditioning regimen in allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) for acute myeloid leukemia ( AML ) in first complete remission ( CR1 ) .
METHODS	Totally 108 AML-CR1 patients undergoing allo-HSCT were randomized into BuCy ( busulfan 1.6 mg/kg , q12 hours , -7 ~ -4 d ; cyclophosphamide 60 mg/kg .
METHODS	d , -3 ~ -2 d ) or BuFlu ( busulfan 1.6 mg/kg , q12 hours , -5 ~ -2 d ; fludarabine 30 mg/m2 .
METHODS	d , -6 ~ -2 d ) group .
METHODS	Hematopoietic engraftment , regimen-related toxicity ( RRT ) , graft-versus-host disease ( GVHD ) , transplant related mortality ( TRM ) , and overall survival were compared between the two groups .
RESULTS	All patients achieved hematopoietic reconstitution except for two patients who died of RRT during conditioning .
RESULTS	All patients obtained complete donor chimerism by day +30 post-transplantation .
RESULTS	The incidence of total and III-IV RRT were 94.4 % and 81.5 % ( P = 0.038 ) , and 16.7 % and 0.0 % ( P = 0.002 ) , respectively , in BuCy and BuFlu group .
RESULTS	With a median follow up of 609 ( range , 3-2130 ) days after transplantation , the 5-year cumulative incidence of TRM were 18.86.9 % and 9.96.3 % ( P = 0.104 ) ; the 5-year cumulative incidence of leukemia relapse were 16.55.8 % and 16.25.3 % ( P = 0.943 ) ; the 5-year disease-free survival and overall survival were 67.47.6 % and 75.37.2 % ( P = 0.315 ) , and 72.37.5 % and 81.97.0 % ( P = 0.177 ) , respectively in BuCy and BuFlu group .
CONCLUSIONS	Compared with BuCy , BuFlu as a myeloablative condition regimen was associated with lower toxicities and comparable anti-leukemic activity in AML-CR1 patients undergoing allo-HSCT .

###22356732
BACKGROUND	Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups .
OBJECTIVE	To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online ( BEO ) , an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition .
METHODS	We randomly assigned 42 socially isolated children and adolescents ( 18 males ) , aged between 10 and 17 years to either a BEO ( final n = 19 ) or a wait-list control ( final n = 20 ) condition .
METHODS	In total , 3 participants ( 2 from BEO and 1 from control ) did not complete the intervention .
METHODS	Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving .
METHODS	Secondary outcome measures included self-reported attitudes toward their illness and spirometry results .
METHODS	Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline ( time 1 ) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group ( time 2 ) .
RESULTS	The two groups were comparable at baseline across all demographic measures ( all F < 1 ) .
RESULTS	For the primary outcome measures , there were no significant group differences on depression ( P = .17 ) or social problem solving ( P = .61 ) .
RESULTS	However , following the online intervention , those in the BEO group reported significantly lower depression ( P = .04 ) , less impulsive/careless problem solving ( P = .01 ) , and an improvement in positive attitude toward their illness ( P = .04 ) compared with baseline .
RESULTS	The wait-list group did not show these differences .
RESULTS	Children in the BEO group and their parents rated the online modules very favorably .
CONCLUSIONS	Although there were no significant group differences on primary outcome measures , our pilot data provide tentative support for the feasibility ( acceptability and user satisfaction ) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition .
BACKGROUND	Australian New Zealand Clinical Trials Registry number : ACTRN12610000214033 ; http://www.anzctr.org.au/trial_view.aspx?ID=308074 ( Archived by WebCite at http://www.webcitation.org/63BL55mXH ) .

###18035193
BACKGROUND	Randomized clinical trials have shown that risedronate reduces the risk for both ver - tebral and nonvertebral fractures in postmenopausal women with osteoporosis ( bone mineral density [ BMD ] T-score , < -2.5 ) .
BACKGROUND	If left untreated , osteopenia ( T-score , between -1 and -2.5 ) may progress to osteo - porosis .
BACKGROUND	Risedronate sodium , a pyridinyl bisphospho - nate , is an antiresorptive drug approved by the US Food and Drug Administration for the prevention and treatment of osteoporosis in postmenopausal women .
BACKGROUND	Although the effects of risedronate in preventing frac - tures has been established , its effects in maintaining or increasing BMD in osteopenia have not .
OBJECTIVE	In this clinical trial , the efficacy and tol - erability of risedronate in improving and maintaining BMD levels in late-postmenopausal women with os - teopenia were assessed .
METHODS	This 24-month , randomized , double - blind , placebo-controlled , parallel-group , Phase III trial was conducted at 14 study centers across Finland , The Netherlands , Norway , Spain , and Sweden .
METHODS	Late - postmenopausal ( > or = 5 years from menopause ) women with lumbar spine ( LS ) BMD T-score between -1 and -2.5 and the presence of > or = 1 additional risk factor for osteo - porosis or proximal femur ( Fern ) BMD T-score < or = -1 were randomized to receive risedronate 5 mg ( n = 114 ) or placebo ( n = 57 ) PO QD for 24 months .
METHODS	The primary efficacy end point was the percentage change from baseline in LS BMD at study end point ( 24 months or last observation carried forward ) .
METHODS	Secondary efficacy end points were the percentage changes from base - line in total proximal Fern BMD and 2 bone turnover markers-urinary type I collagen cross-linked N-telopeptide ( uNTx ) and serum bone-specific alkaline phosphatase ( sBAP ) - at 12 months and study end point .
METHODS	Tolerability was assessed using reported adverse events ( AEs ) , laboratory analysis , and physical exami - nation including vital-sign measurements .
RESULTS	A total of 171 women were included ( mean [ SD ] age , 65.9 [ 6.8 ] years ; mean [ SD ] LS BMD T-score , -1.82 [ 0.42 ] ; risedronate group , 114 patients ; placebo group , 57 ) .
RESULTS	At study end point , LS BMD had significantly increased from baseline in the risedronate group ( P < 0.05 ) but remained unchanged in the placebo group ( mean [ SE ] % Delta , +4.49 % [ 0.38 % ] and +0.05 % [ 0.54 % ] , respectively ; P < 0.001 ) .
RESULTS	Between - treatment differences in mean ( SE ) percentage changes from baseline in LS BMD and Fem BMD were signif - icant at 12 months and study end point ( LS BMD , both P < 0.001 ; Fem BMD , P = 0.002 and P < 0.001 , respectively ) .
RESULTS	At 12 months and study end point , ris - edronate use was associated with significantly reduced concentrations of uNTx and sBAP compared with placebo ( both , P < 0.001 ) .
RESULTS	Risedronate treatment was well tolerated with regard to gastrointestinal AEs ; the most frequent AEs in the risedronate group were hy - pertension ( n = 13 ) , constipation ( n = 8 ) , and hyper - cholesterolemia ( n = 8 ) .
CONCLUSIONS	In these late-postmenopausal women with LS osteopenia and > or = 1 additional risk factor or hip osteopenia , 24-month treatment with risedronate 5 mg/d was associated with the prevention of bone loss at the spine and hip ( based on significant increases in BMD in the LS and total proximal Fem ) and reduced bone resorption ( based on significantly reduced concen - trations of uNTx and sBAP ) and was well tolerated .

###15001247
OBJECTIVE	To identify dose-volume parameters related to late rectal bleeding after radiotherapy for prostate cancer .
METHODS	Clinical complication data from a randomized trial were collected and linked to the individual dose-volume data .
METHODS	In this trial , patients with prostate cancer were treated with either conventional ( with rectangular fields ) or three-dimensional conformal radiotherapy to a dose of 66 Gy .
METHODS	Patient complaints , including rectal blood loss , were collected for 199 patients , using questionnaires .
METHODS	Absolute and relative dose-volume histograms ( DVHs ) of the rectal wall ( with and without the anal region ) were calculated with and without rectal filling .
METHODS	A proportional hazard regression ( PHR ) model was applied to estimate the probability of any rectal blood loss within 3 years , as a function of several DVH parameters .
METHODS	In a multivariable analysis , dose-volume parameters were tested together with patient - and treatment-related parameters ( age , smoking , diabetes , cardiovascular disease , tumor stage , neo-adjuvant androgen deprivation , conformal vs. conventional and rectal bleeding during treatment ) .
RESULTS	The estimated incidence of any and moderate/severe rectal bleeding at 3 years was 33 % and 8 % , respectively .
RESULTS	Differences between the conventional and conformal technique were small and not significant .
RESULTS	The analysis of relative DVHs of the rectal wall ( with and without the anal region ) , showed significant ( p < 0.01 ) relations between the irradiated volume and the probability of rectal blood loss within 3 years for dose levels between 25 Gy and 60 Gy .
RESULTS	This relationship was shown in subgroups defined by dose-volume cutoff points as well as in the PHR model , in which a continuously rising risk was seen with increasing volumes .
RESULTS	For absolute DVHs and DVHs of the rectum including filling , less or no significant results were observed .
RESULTS	The most significant volume-effect relation ( p = 0.002 ) was found at 60 Gy for the rectum wall excluding the anal region .
RESULTS	The probability of rectal bleeding increased from 10 % to 63 % when the irradiated rectum volume at 60 Gy increased from 25 % to 100 % .
RESULTS	Other factors .
RESULTS	including age , smoking , diabetes , cardiovascular disease , tumor stage , neo-adjuvant androgen deprivation , conformal vs. conventional , rectal bleeding during treatment , rectum length .
RESULTS	and whole rectum volume .
RESULTS	did not have a significant effect in the multivariable analysis .
RESULTS	When controlling for the volumes at 60 Gy , the volumes at lower dose levels ( 25-55 Gy ) were no longer significant ( p = 0.5 ) .
CONCLUSIONS	For any rectal bleeding within 3 years , an overall incidence of 33 % was observed for patients treated to 66 Gy .
CONCLUSIONS	For this endpoint , a volume-effect relation was found for DVH parameters of the relative rectal wall volume .
CONCLUSIONS	This relationship appeared to be most significant for the rectum without the anal region and for the higher dose levels ( 50-60 Gy ) .

###24343388
OBJECTIVE	The purpose of this study was to compare cosmesis at 3 to 4 months and infection in simple lacerations irrigated with normal saline ( NS ) versus activated chlorine dioxide ( CD ) .
METHODS	This was a prospective , randomized trial of a convenience sample of patients .
METHODS	This study was approved by the institutional review board and Food and Drug Administration as a physician-sponsored trial ( FDA investigational new drug no. 68762 ) .
METHODS	The study was conducted in a large urban , academic emergency department .
METHODS	Patients aged 18 to 100 with simple , uncomplicated lacerations requiring repair that were less than 8 hours old were enrolled .
METHODS	Patients were randomized to receive either NS or CD wound irrigation .
METHODS	Demographics , infection , and cosmesis were analyzed and assessed .
METHODS	Cosmetic outcome was assessed at 3 to 4 months using a visual analog scale ( VAS ) , wound evaluation score ( WES ) , patient VAS ( VASPt ) , and digital imaging VAS by 2 plastic surgeons ( VASPlast ) .
RESULTS	One hundred ninety-three patients were enrolled .
RESULTS	Data analysis was available for 175 cases ( 86 NS and 89 CD ) .
RESULTS	Wound infection follow-up was obtained in 74.9 % of the patients .
RESULTS	The 3 - to 4-month cosmesis follow-up was 37.7 % for VAS/WES , 40.0 % for VASPt , and 37.7 % for VASPlast .
RESULTS	There were no significant differences in demographics , key wound characteristics , infection , adverse reactions , and cosmesis .
CONCLUSIONS	The authors report the use of a novel antimicrobial irrigation solution .
CONCLUSIONS	Chlorine dioxide appears to be a safe biologically acceptable antiseptic wound irrigant that does not appear to interfere with cosmetic outcomes .

###2012082
OBJECTIVE	To compare the efficacy and safety of three different doses of prophylactic aerosol pentamidine in patients with one prior episode of Pneumocystis carinii pneumonia ( PCP ) and the acquired immunodeficiency syndrome .
METHODS	The design of the study was a double-blind , randomized , dose-comparison clinical trial conducted at 13 medical centers within the United States .
METHODS	In stage I of the trial , patients were randomized to receive either 5 mg , 60 mg , or 120 mg of aerosol pentamidine delivered biweekly with the Fisoneb ( Fisons , Inc. , Rochester , New York ) ultrasonic nebulizer .
METHODS	After 24 weeks of therapy , patients entered stage II of the trial , where the 5-mg group was re-randomized to either the 60-mg or 120-mg group .
RESULTS	One hundred seventy-five patients entered stage I of the trial and received prophylaxis for a mean of 123.6 days .
RESULTS	Seven assigned to the 5-mg biweekly dosing schedule had a confirmed recurrence of PCP , compared with none in the 60-mg group ( p = 0.007 ) and three in the 120-mg group ( p = 0.304 ) .
RESULTS	During stage II of the trial , eight patients in the 60-mg group and one additional patient in the 120-mg group had recurrent PCP .
RESULTS	After 52 weeks of observation , the likelihood of being PCP-free was 88.0 % in the 60-mg group and 93 % in the 120-mg group ( p = 0.712 ) .
RESULTS	Minor adverse events related to aerosol pentamidine administration included cough , taste perversion , chest pain , bronchospasm , and dyspnea .
RESULTS	These side effects were more common in the 60-mg and 120-mg treatment groups and resulted in withdrawal from the study by one patient .
RESULTS	Serious events were more common after 24 weeks of therapy and included asymptomatic hypoglycemia ( five ) , pancreatitis ( two ) , pneumothorax ( one ) , and extrapulmonary pneumocystosis ( one ) .
CONCLUSIONS	These results demonstrate that biweekly administration of 60 mg or 120 mg of aerosol pentamidine significantly decreases PCP recurrence when compared with a 5-mg regimen or findings in historic controls and is generally well tolerated .
CONCLUSIONS	There is no significant difference in effect or safety between these two dosing regimens in patients followed for at least 52 weeks of therapy .

###17663731
BACKGROUND	The risk of decreased bone mineral density ( BMD ) with prophylactic dose long-term low-molecular-weight heparin ( LMWH ) is unknown .
OBJECTIVE	We sought to determine whether long-term prophylactic dalteparin in pregnancy leads to loss of BMD .
METHODS	Patients in a substudy of an ongoing multicenter randomized trial investigating the effect of antepartum dalteparin prophylaxis on pregnancy outcomes in thrombophilic pregnant women were randomized to either dalteparin 5000 U s.c. daily until 20 weeks and then 5,000 U s.c. q12 h until > 37 weeks or to the control group .
METHODS	The primary outcome was absolute spine BMD at six weeks postpartum .
RESULTS	Of 77 patients eligible for the BMD substudy , 62 were analyzed .
RESULTS	33 patients received a mean of 212 days of dalteparin in the intervention group .
RESULTS	29 patients received a mean of 38 days of postpartum dalteparin in the control group .
RESULTS	There was no difference in mean BMD between the intervention ( 1.11 g cm ( -2 ) ) and the control groups ( 1.14 g cm ( -2 ) ) .
RESULTS	Similarly , there was no difference in T-scores ; the difference of -0.34 ( 95 % confidence interval -0.93 to +0.25 ) in favor of the control group excludes a clinically important increase in fracture risk .
CONCLUSIONS	Our results suggest that the use of long-term prophylactic dalteparin in pregnancy is not associated with a significant decrease in BMD .
BACKGROUND	ISRCTN87441504 at http://www.controlled-trials.com .

###21747085
OBJECTIVE	We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected , low-risk , stage II colon cancer .
OBJECTIVE	This study also prospectively studied patient - and tumor-specific markers of treatment outcome .
METHODS	After surgical resection , patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy .
RESULTS	Final accrual included 1,738 patients ; 865 patients received edrecolomab , and 873 patients were observed without adjuvant treatment .
RESULTS	Median follow-up time was 7.9 years .
RESULTS	There were no significant outcome differences between study arms ( overall survival [ OS ] , P = .71 ; disease-free survival , P = .64 ) .
RESULTS	The combined 5-year all-cause OS was 0.86 ( 95 % CI , 0.84 to 0.88 ) , and the combined 5-year disease-specific OS was 0.93 ( 95 % CI , 0.91 to 0.94 ) .
RESULTS	The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes , but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer .
CONCLUSIONS	Edrecolomab did not prolong survival .
CONCLUSIONS	Consequently , this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer .
CONCLUSIONS	Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort .
CONCLUSIONS	Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients .

###10887926
OBJECTIVE	To evaluate the effectiveness of phenylephrine 2.5 % and flurbiprofen 0.03 % combined in inducing and maintaining mydriasis during extracapsular cataract extraction ( ECCE ) .
METHODS	One hundred patients undergoing ECCE + intraocular lens ( IOL ) implantation were randomly divided into four groups .
METHODS	The first group was given phenylphrine 10 % , the second group phenylephrine 10 % + flurbiprofen , the third group phenylephrine 2.5 % and fourth group phenylephrine 2.5 % + flurbiprofen .
METHODS	Cyclopentolate 1 % was used in all patients .
METHODS	Phenylephrine and cyclopentolate were instilled preoperatively four times during 1 hour and flurbiprofen was given four times the day before surgery and twice with an hour 's interval before operation .
METHODS	Pre-operative and post-cortex aspiration horizontal pupil diameters were measured with callipers viewed through the operating microscope .
RESULTS	Pupil diameters in pre-operative and post-cortex aspiration were no different in the 2.5 % and 10 % phenylephrine groups ( p > 0.05 ) .
RESULTS	Both diameters were larger and pupillary constriction was smaller in the flurbiprofen groups ( p < 0.05 ) .
CONCLUSIONS	2.5 % phenylephrine was as effective as 10 % phenylephrine , with and without flurbiprofen , in inducing and maintaining pupil dilatation during ECCE surgery .

###23533227
BACKGROUND	Aging in men is associated with reduced testosterone ( T ) levels and physiological changes leading to frailty , but the benefits of T supplementation are inconclusive .
OBJECTIVE	We studied the effects of T supplementation with and without progressive resistance training ( PRT ) on functional performance , strength , and body composition .
METHODS	We recruited 167 generally healthy community-dwelling older men ( 66 5 years ) with low-normal baseline total T levels ( 200-350 ng/dL ) .
METHODS	Subjects were randomized to placebo or transdermal T gel [ 2 doses targeting either a lower ( 400-550 ng/dL ) or higher ( 600-1000 ng/dL ) T range ] and to either PRT or no exercise for 12 months .
METHODS	The primary outcome was functional performance , whereas secondary outcomes were strength and body composition .
RESULTS	A total of 143 men completed the study .
RESULTS	At 12 months , total T was 528 287 ng/dL in subjects receiving any T and 287 65 ng/dL in the placebo group .
RESULTS	In the PRT group , function and strength were not different between T - and placebo-treated subjects , despite greater improvements in fat mass ( P = .04 ) and fat-free mass ( P = .01 ) with T.
RESULTS	In the non-PRT group , T did not improve function but improved fat mass ( P = .005 ) , fat-free mass ( P = .03 ) , and upper body strength ( P = .03 ) compared with placebo .
RESULTS	There were fewer cardiovascular events in the T-treated groups compared with placebo .
CONCLUSIONS	T supplementation was well tolerated and improved body composition but had no effect on functional performance .
CONCLUSIONS	T supplementation improved upper body strength only in nonexercisers compared with placebo .

###24383121
OBJECTIVE	In the SAVE-trial we evaluated the safety , reliability and improvements of patient management using the BIOTRONIK Home Monitoring-System ( HM ) in pacemaker ( PM ) and implanted cardioverter defibrillator ( ICD ) patients .
METHODS	115 PM ( Module A ) and 36 ICD-patients ( Module B ) were recruited 3 months after implantation .
METHODS	65 patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up ( FU ) per year , whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU .
METHODS	In Module B 18 patients were randomised to HM-OFF and followed by standard outpatient clinic controls every 6 months ; 18 patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year ; unscheduled follow-ups were performed when necessary .
RESULTS	The average follow-up period was 17.1 9.2 months in Module A and 26.3 8.6 months in Module B.
RESULTS	In both modules , the number of FUs per year was significantly reduced ( Module A HM-ON 0.29 0.6 FUs/year vs HM-OFF 0.53 0.5 FUs/year ; p b 0.001 ; Module B HM-ON 0.87 0.25 vs HM-OFF 1.73 0.53 FU/year , p b 0.001 ) .
RESULTS	Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group ( 18.0 41.3 and 22.4 26.9 respectively ; p b 0.003 ) .
RESULTS	93 % of the unscheduled visits in Module B were clinically indicated , whereas 55 % of the routine FUs were classified as clinically unnecessary .
CONCLUSIONS	Remote home monitoring of pacemaker and ICD devices was safe , reduced overall hospital visits , and detected events that mandated unscheduled visits .

###7878558
BACKGROUND	Reversibility after administration of an inhaled bronchodilator is not always demonstrable in patients with asthma .
BACKGROUND	Bronchodilator aerosol-induced bronchoconstriction has also been reported to occur in some patients .
METHODS	Fifteen selected patients showing < 10 % improvement in forced expiratory volume in one second ( FEV1 ) when tested with four doses of salbutamol ( 0.1 mg/dose ) or terbutaline ( 0.25 mg/dose ) from a pressurised metered dose inhaler ( MDI ) participated in two randomised , double blind studies .
METHODS	They received 2.0 mg terbutaline ( 4 x 2 doses of 0.25 mg ) or a corresponding placebo from an MDI connected to a 750 ml spacer , and 1.0 mg ( 2 x 0.5 mg ) terbutaline or placebo from a multidose dry powder inhaler free of additives ( Turbohaler ) .
RESULTS	Inhalation of placebo MDI resulted in a mean ( SD ) decrease in FEV1 of 20.5 ( 14.1 ) % ( range -42.9 % to +2.6 % ) .
RESULTS	In 14 patients inhalation of 2.0 mg terbutaline MDI with spacer resulted in < 10 % improvement ( mean increase 3.1 ( 6.0 ) % ) .
RESULTS	One mg of terbutaline via a Turbohaler resulted in improvements in FEV1 of > 15 % in eight patients ( mean increase 16.0 ( 9.7 ) % ) .
RESULTS	The improvement was < 10 % in four patients .
RESULTS	Use of placebo Turbohaler did not affect airway calibre ( mean change 0.2 ( 2.9 ) % ) .
CONCLUSIONS	Additives of MDIs may cause bronchoconstriction in some patients with asthma .
CONCLUSIONS	In these patients inhalation from a pressurised metered dose inhaler is more likely to decrease the bronchodilator response than inhalation from an additive-free inhaler .
CONCLUSIONS	The frequency of this phenomenon is unknown .

###15715188
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is characterised by airway inflammation , poor health status and recurrent infective exacerbations .
BACKGROUND	Macrolide antibiotics have been shown to improve symptoms and exacerbation rate in chronic lung disease , particularly cystic fibrosis ( CF ) and diffuse pan-bronchiolitis .
BACKGROUND	The effect of long-term oral clarithromycin on health status , sputum bacterial numbers and exacerbation rate in subjects with clinically stable COPD is undetermined .
METHODS	Subjects with moderate-to-severe COPD were recruited into a prospective , double-blind , randomised-controlled trial of 3-months oral clarithromycin ( Klaricid XL ) or placebo once-daily .
METHODS	The effect of clarithromycin on health status ( St. George respiratory and Short Form-36 questionnaires ) , sputum quantitative bacterial numbers and exacerbation rate were investigated .
RESULTS	Sixty-seven subjects ( 46 males ) were recruited ; 31 and 36 subjects received clarithromycin and placebo , respectively .
RESULTS	There were 7 ( 10 % ) withdrawals .
RESULTS	Compared to placebo , clarithromycin did not significantly improve health status , sputum bacterial numbers , or exacerbation rate .
CONCLUSIONS	Three months of oral clarithromycin given to subjects with stable COPD does not improve health status , sputum bacterial numbers or exacerbation rate .
CONCLUSIONS	Treatment of COPD with clarithromycin during the clinical stable state yields no clinical advantages and therefore can not be recommended as means of eliminating sputum bacteria or preventing infective exacerbations .

###11063475
BACKGROUND	Few studies have shown the efficacy and safety of lower-fat diets in children .
OBJECTIVE	Our objective was to assess the efficacy and safety of lowering dietary intake of total fat , saturated fat , and cholesterol to decrease LDL-cholesterol concentrations in children .
METHODS	A 6-center , randomized controlled clinical trial was carried out in 663 children aged 8-10 y with LDL-cholesterol concentrations greater than the 80th and less than the 98th percentiles for age and sex .
METHODS	The children were randomly assigned to either an intervention group or a usual care group .
METHODS	Behavioral intervention promoted adherence to a diet providing 28 % of energy from total fat , < 8 % from saturated fat , < / = 9 % from polyunsaturated fat , and < 0.018 mg cholesterol * kJ ( - ) ( 1 ) * d ( - ) ( 1 ) ( not to exceed 150 mg/d ) .
METHODS	The primary efficacy measure was mean LDL cholesterol and the safety measures were mean height and serum ferritin concentration at 3 y.
RESULTS	At 3 y , dietary total fat , saturated fat , and cholesterol were lower in the intervention group than in the usual care group ( all P : < 0.001 ) .
RESULTS	LDL cholesterol decreased in the intervention and usual care groups by 0.40 mmol/L ( 15.4 mg/dL ) and 0.31 mmol/L ( 11.9 mg/dL ) , respectively .
RESULTS	With adjustment for baseline concentration , sex , and missing data , the mean difference between groups was -0.08 mmol/L ( 95 % CI : -0.15 , -0.01 ) , or -3.23 mg/dL ( 95 % CI : -5.6 , -0.5 ) ( P : = 0.016 ) .
RESULTS	There were no significant differences between groups in adjusted mean height or serum ferritin .
CONCLUSIONS	Dietary changes are effective in achieving modest lowering of LDL cholesterol over 3 y while maintaining adequate growth , iron stores , nutritional adequacy , and psychological well-being during the critical growth period of adolescence .

###11128732
OBJECTIVE	To determine the inter/intra-rater reliability of expert physiotherapists ( PTs ) measuring post-stroke shoulder pain with 100 mm vertical visual analogue scales ( VAS ; intensity , frequency and affective response ) and a categorical site-of-pain scale .
METHODS	Three PTs independently rated subjects ( normal clinical procedure but with a standardized starting position ) on three days , at the same time of day , during one week in a randomized order determined by a nested latin square .
METHODS	Reliability for VAS scores was determined with the intraclass correlation coefficient ( ICC ) and for site-of-pain with the kappa statistic ( kappa ) .
METHODS	Acceptable reliability was set at 0.75 .
METHODS	The limits of agreement were also calculated .
METHODS	Community .
METHODS	Thirty-three patients , mean time post stroke 42 months ( range 7-360 ) .
RESULTS	Mean inter-rater reliability was 0.79 for intensity , 0.75 for frequency and 0.62 for affective response ( ICC ) .
RESULTS	The limits of agreement were wide and rater bias was significant for 6/27 ratings .
RESULTS	Mean intra-rater reliability was 0.70 for intensity , 0.77 for frequency and 0.69 for affective response ( ICC ) .
RESULTS	For site-of-pain inter-rater reliability ranged from 0.156 ( kappa ) to 0.385 ( kappa ) and intrarater reliability ranged from 0.300 ( kappa ) to 0.559 ( kappa ) .
CONCLUSIONS	Although inter-rater reliability was acceptable for intensity and frequency there was a consistently large systematic bias between pairs of raters .
CONCLUSIONS	Agreement might be improved if a standardized assessment procedure was used and/or if training in pain behaviour interpretation was provided .

###20132153
BACKGROUND	Nocturnal heartburn is common in patients with gastro-oesophageal reflux disease ( GERD ) .
OBJECTIVE	To compare the effects of single doses of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure ( OAE ) .
METHODS	A total of 52 subjects with GERD and a > or = 6-month history of heartburn were randomized into a blinded , 2 x 2 crossover trial .
METHODS	Subjects ' intragastric pH was monitored in two 48-h study periods with 6 - to 13-day washout between periods .
METHODS	Patients received placebo on day 1 , a single dose of rabeprazole 20 mg or pantoprazole 40 mg on day 2 , and standardized meals throughout .
RESULTS	The mean percentage time with intragastric pH > 4 was significantly greater with rabeprazole vs. pantoprazole for the 24-h postdose interval ( 44.0 % vs. 32.8 % ; P < 0.001 ) .
RESULTS	Significant differences were observed in the daytime ( 51.0 % vs. 42.2 % ; P < 0.001 ) and nighttime ( 32.0 % vs. 16.9 % ; P < 0.001 ) .
RESULTS	Rabeprazole was also significantly superior in other intragastric pH parameters .
RESULTS	There was no statistical difference for OAE between treatments .
CONCLUSIONS	In GERD patients with nocturnal heartburn , rabeprazole 20 mg was significantly more effective than pantoprazole 40 mg in percentage time with intragastric pH > 4 during the nighttime , daytime , and 24-h periods .
CONCLUSIONS	Differences between treatments in OAE were not demonstrated .
CONCLUSIONS	This trial is registered with http://clinicaltrials.gov , number NCT00237367 .

###15311287
OBJECTIVE	To describe women 's preferred route of delivery and physicians ' viewpoint on that .
METHODS	A total of 656 women who gave birth in the National Health System hospitals of the state of So Paulo and Pernambuco and were enrolled in the Latin American Cesarean Section Study ( ELAC ) were interviewed .
METHODS	Of them , 230 women were selected from three intervention hospitals where patients routinely sought a second opinion when faced with the decision of undergoing a cesarean section , and 426 women were selected from control hospitals .
METHODS	Also , 72 physicians in the intervention hospitals and 70 in the control hospitals filled out a self-administered structured questionnaire .
METHODS	Data analysis was carried out using Mantel-Haenszel 's chi-square test , Yates ' test and Fischer 's exact test .
RESULTS	The majority of women reported preferring vaginal delivery than a cesarean section in both groups of hospitals .
RESULTS	This preference was significantly higher among women who had had both vaginal delivery and cesarean section ( nearly 90 % in both groups of hospitals ) compared to those who had cesarean sections only ( 72.8 % in intervention hospitals and 77.8 % in control hospitals ) .
RESULTS	According to 45 % physicians from intervention hospitals and 55 % from control hospitals , most women who underwent cesarean sections are satisfied with that ; 81 % and 85 % physicians from intervention and control hospitals , respectively , believed women prefer a cesarean sections out of fear of vaginal deliveries .
CONCLUSIONS	The belief that the main reason for increasing cesarean section rates is fulfilling women 's desire by their doctors seems to have no support .
CONCLUSIONS	Better communication between physicians and pregnant women could possibly contribute to improve the current situation .

###9176446
OBJECTIVE	To compare ultrasound-guided transmyometrial and transcervical ET in patients with cervical stenosis or in patients who failed to conceive after at least three previous IVF-ET cycles .
METHODS	A prospective , randomized study .
METHODS	The IVF-ET Unit at Serlin Maternity Hospital .
METHODS	Forty patients undergoing IVF-ET .
METHODS	Ultrasound-guided transvaginal , transmyometrial , versus transcervical ET .
METHODS	Clinical pregnancy rate .
RESULTS	Transmyometrial ET was performed in 20 patients and resulted in one clinical pregnancy .
RESULTS	Transcervical ET , performed in another 20 similar patients , resulted in three clinical pregnancies .
CONCLUSIONS	No benefit was derived by electing transmyometrial ET in preference to transcervical ET in patients who had failed to conceive in previous cycles .

###11772696
OBJECTIVE	The efficacy of fluoxetine in the acute management of bulimia nervosa is well established ; however , few controlled studies have examined whether continuation of pharmacotherapy provides protection from relapse .
OBJECTIVE	This study compared the efficacy and safety of treatment with fluoxetine versus placebo in preventing relapse of bulimia nervosa during a 52-week period after successful acute fluoxetine therapy .
METHODS	Patients who met DSM-IV criteria for bulimia nervosa , purging type , were assigned to single-blind treatment with 60 mg/day of fluoxetine .
METHODS	After 8 weeks of treatment , patients were considered responders if they experienced a decrease > or = 50 % from baseline in the frequency of vomiting episodes during 1 of the 2 preceding weeks .
METHODS	Responders were randomly assigned to receive 60 mg/day of fluoxetine or placebo and were monitored for relapse for up to 52 weeks .
METHODS	Patients met relapse criteria if they experienced a return to the baseline vomiting frequency that persisted for 2 consecutive weeks .
RESULTS	Of the 232 patients who entered the acute phase , 150 patients ( 65 % ) met response criteria and were randomly assigned to receive fluoxetine ( N = 76 ) or placebo ( N = 74 ) .
RESULTS	Fluoxetine-treated patients exhibited a longer time to relapse than placebo-treated patients .
RESULTS	Quantitative analysis of other efficacy measures , including frequency of vomiting episodes , frequency of binge eating episodes , Clinical Global Impression severity and improvement scores , the patient 's global impression score , and Yale-Brown-Cornell Eating Disorder Scale score , indicated that the efficacy of fluoxetine treatment was statistically superior , compared to placebo .
RESULTS	There were no clinically relevant differences in safety between groups .
RESULTS	Attrition in this study was high , especially in the first 3 months after random assignment to treatment groups .
CONCLUSIONS	Continued treatment with fluoxetine in patients with bulimia nervosa who responded to acute treatment with fluoxetine improved outcome and decreased the likelihood of relapse .

###21935504
OBJECTIVE	To ( 1 ) evaluate the use of adenosine triphosphate ( ATP ) - driven bioluminescence for quantification of total plaque bacteria in orthodontic patients , ( 2 ) compare plaque bacteria amounts at the bracket-tooth interface with use of elastomeric-ligated and self-ligating brackets after 1 year of orthodontic treatment , and ( 3 ) analyze formation of white spot lesions by photographic evaluation and laser-light fluorescence ( DIAGNOdent ) .
METHODS	Thirteen subjects had fixed orthodontic appliances placed where lateral incisors were bonded with either elastomeric-ligated or self-ligating brackets .
METHODS	Plaque bacteria were collected from incisor surfaces after 1 year and quantified using plating methods and ATP-driven bioluminescence .
METHODS	White spot lesions were evaluated by photographic and DIAGNOdent determinations .
METHODS	A 2 x 2 x 2 mixed-design ANOVA was conducted to determine differences in plaque retention between elastomeric-ligated and self-ligating brackets .
RESULTS	ATP-driven bioluminescence values correlated to numbers of total plaque bacteria ( r = 0.80 ) .
RESULTS	However , unlike findings published in the original pilot study , which described increased plaque retention with elastomeric-ligated brackets at 5 weeks postbonding , there were no significant differences in bacterial numbers or ATP-driven bioluminescence values surrounding the elastomeric-ligated vs self-ligating brackets after 1 year of orthodontic treatment .
RESULTS	Based on photographic and DIAGNOdent determinations , white spot lesions were found relatively equally on teeth bonded with either bracket type .
RESULTS	DIAGNOdent measurements were found to have moderate sensitivity ( 0.71 ) and good specificity ( 0.88 ) when compared to white spot lesions determined using photographic evaluation .
CONCLUSIONS	ATP-driven bioluminescence can be used as an accurate assessment of total plaque bacteria in orthodontic patients .
CONCLUSIONS	After 1 year of orthodontic treatment for patients in this pilot study , there appeared to be no differences in retention of plaque bacteria or white spot lesions comparing the bracket types .
CONCLUSIONS	The use of DIAGNOdent has some limitations , but may prove to be useful to monitor white spot lesions longitudinally .

###24511099
BACKGROUND	Complicated skin and skin structure infections ( cSSSIs ) are characterized by infections with gram-positive or gram-negative aerobic or anaerobic bacteria , as well as by a polymicrobial etiology .
BACKGROUND	These invading microorganisms are recognized by pattern-recognition receptors ( PRRs ) of the innate immune system .
BACKGROUND	This study assessed whether genetic variation in genes encoding PRRs influences the susceptibility to cSSSIs .
METHODS	A total of 318 patients with cSSSI and 328 healthy controls were genotyped for 9 nonsynonymous single-nucleotide polymorphisms ( SNPs ) in PRR genes coding for Toll-like receptors ( TLRs ) 1 , 2 , 4 , and 6 ; NOD-like receptor 2 ; and the signaling adaptor molecule TIRAP .
METHODS	Associations between susceptibility to cSSSIs and a SNP were investigated by means of logistic regression models .
METHODS	In an additional cohort of 74 healthy individuals in whom the same SNPs were genotyped , peripheral blood mononuclear cells ( PBMCs ) were obtained and stimulated with Staphylococcus aureus .
METHODS	Interleukin 6 concentrations were determined in supernatants by enzyme-linked immunosorbent assay to determine the correlation between genotypes and levels of IL-6 secretion .
RESULTS	In the genetic association analysis , polymorphisms in TLR1 ( S248N and R80T ) , TLR2 ( P631H ) , and TLR6 ( P249S ) were associated with an increased susceptibility to cSSSIs .
RESULTS	No association with susceptibility to cSSSIs was observed for polymorphisms TLR2 ( R753Q ) , TLR4 ( D299G and T399I ) , NOD2 ( P268S ) , and TIRAP ( S180L ) .
RESULTS	In the functional analysis , individuals bearing the TLR1 248N or 80T allele showed lower IL-6 secretion upon stimulation with S. aureus .
CONCLUSIONS	Polymorphisms in TLR1 , TLR2 , and TLR6 are associated with increased susceptibility to cSSSIs .
CONCLUSIONS	For TLR1 , impaired proinflammatory cytokine production due to the polymorphism is most likely the mechanism mediating this effect .

###21784296
OBJECTIVE	To examine the efficacy and durability of a behavioral therapy ( BT ) protocol for pediatric TTM compared with a minimal attention control ( MAC ) condition .
OBJECTIVE	It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment , and would also demonstrate durability of gains through the maintenance treatment phase .
METHODS	A randomized controlled trial in which 24 youths were assigned to either a pilot-tested BT protocol , consisting of eight weekly sessions , or to MAC , consisting of three sessions and five telephone calls over 8 weeks .
METHODS	Independent evaluators assessed outcome at pretreatment ( week 0 ) and post-treatment ( week 8 ) for BT and MAC , and again at week 16 for BT patients only .
METHODS	The primary outcome measure was the National Institute of Mental Health Trichotillomania Severity Scale ( NIMH-TSS ) .
RESULTS	For the BT condition , the week 8 mean NIMH-TSS score was significantly lower than that of the MAC condition .
RESULTS	The BT condition 's mean week 8 score was also significantly lower than their own mean week 0 score , whereas no such reductions were observed for the MAC condition .
RESULTS	Upon completion of acute treatment at week 8 , the BT group 's gains were maintained through an 8-week maintenance treatment phase .
CONCLUSIONS	BT produced a superior outcome compared with a condition that controlled for participation in a pediatric TTM research study , nonspecific therapist contact effects , repeated assessments , and the passage of time .
CONCLUSIONS	Maintenance of gains after acute BT provides preliminary support for the durability of treatment gains .
BACKGROUND	Cognitive Behavioral Treatment of Pediatric Trichotillomania ; http://www.clinicaltrials.gov; R21 MH 61457 .

###22666833
OBJECTIVE	This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel , after 1-year follow-up .
METHODS	Thirteen volunteers requiring at least two posterior composite restorations were selected .
METHODS	Twenty-nine cavities were performed , comprising 14 without bevel ( butt joint ) and 15 with bevel preparation of the enamel cavosurface angle .
METHODS	All cavities were restored with simplified adhesive system ( Adper Single Bond ) and composite resin ( Filtek P60 ) .
METHODS	A halogen light curing unit was used through the study .
METHODS	Restorations were polished immediately .
METHODS	Analysis was carried out at baseline , after 6 months and after 1 year by a calibrated evaluator ( Kappa ) , according to the FDI criteria .
METHODS	Data were statistically analyzed by Mann-Whitney test ( p < 0.05 ) .
RESULTS	Beveled and non-beveled cavities performed similarly after 1 year follow-up , regarding to fractures and retention , marginal adaptation , postoperative hypersensitivity , recurrence of caries , surface luster and anatomic form .
RESULTS	However , for surface and marginal staining , beveled cavities showed significantly better performance ( p < 0.05 ) than butt joint restorations .
CONCLUSIONS	It was concluded that the restorations were acceptable after 1 year , but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities .

###8899773
OBJECTIVE	To assess the postoperative fate of bone trapdoors in patients with a trapdoor in the facial wall of the maxillary sinus that was replaced after removal of sinus disease .
METHODS	Twenty patients were studied .
METHODS	In 10 patients ( group A ) the trapdoor was made as a free bone graft ; in the other 10 patients ( group B ) , an osteoperiosteal trapdoor was made .
METHODS	The postoperative fate of bone trapdoors was studied by means of computed tomography .
RESULTS	In group A there was poor bony consolidation at the trapdoors ' junction with the surrounding bone and a significantly reduced density of the osteotomized bone .
RESULTS	In two of the group A patients there was a partial loss of the trapdoor .
RESULTS	In group B , however , bony consolidation took place in that all the trapdoors were completely connected again to the surrounding bone and there was no reduction of the bone density .
CONCLUSIONS	The results indicate that a trapdoor with a periosteal pedicle appears to be more reliable than one without a periosteal pedicle .

###9262882
OBJECTIVE	To study the effects of over-the-counter dosages of the pure alpha 1-agonists pseudoephedrine ( PSE ) and phenylpropanolamine ( PPA ) on selected parameters of exercise performance , and to establish a range of corresponding drug levels in the urine of the athletes who use these drugs .
METHODS	Placebo-controlled , randomized , double-blinded , multiple-dose trial .
METHODS	The National Institute of Fitness and Sport , the Department of Family Medicine , Indiana University , and the Sports Medicine Lab , Department of Pathology , Indiana University , Indianapolis , Indiana .
METHODS	A convenience sample of 20 male cyclists , aged 18-35 , from the local cycling community .
METHODS	Inclusion criteria required cycling at least 50 miles a week , no chronic medical problems , and not taking any medications .
METHODS	Subjects were recruited by local ads and word of mouth .
METHODS	Patients were randomized to one of two groups of 10 subjects .
METHODS	Each subject in both groups performed three separate bicycle ergometer tests after ingestion of varying dosages of alpha 1-agonists .
METHODS	One group performed tests after receiving placebo , 0.33 mg/kg PPA , and 0.66 mg/kg PPA , whereas the other group received placebo , 1 mg/kg PSE , and 2 mg/kg PSE .
METHODS	A minimum 1-week washout period was required between tests .
METHODS	Urine for drug testing was collected 1 h before , immediately afterward , and the next morning after testing .
METHODS	Drug testing was performed by gas GC/MCD at a facility approved by the International Olympic Committee .
METHODS	Maximum oxygen uptake ( VO2max ) , time to exhaustion , urine drug levels of PSE and PPA , peak blood pressures ( BPs ) , peak pulse , and Borg scale ( rating of perceived exertion or RPE ) .
RESULTS	In the PPA group , the 0.33-mg / kg dose resulted in insignificant changes in peak systolic BP ( +5.4 mm Hg , p = 0.260 ) , peak diastolic BP ( -1.6 mm Hg , p = 0.622 ) , peak pulse ( -2.2 beats/min , p = 0.12 ) , peak Borg ( RPE = -0.10 ( p = 0.823 ) , time to exhaustion ( -16.9 s , p = 0.287 ) , and VO2max ( +0.50 ml/kg/min , p = 0.71 ) .
RESULTS	No significant change was noted in any study variable at the 0.66-mg / kg PPA dose , and some effects were dissimilar to the lower PPA dose effects .
RESULTS	Peak systolic BP increased 2.8 mm Hg ( p = 0.617 ) , diastolic BP decreased 1.6 mm Hg ( p = 0.634 ) , peak pulse increased 1.4 beats/min ( p = 0.504 ) , peak Borg RPE decreased 0.80 ( p = 0.210 ) , time to exhaustion decreased 2.6 s ( p = 0.861 ) , and VO2max decreased 2.92 ml/kg/min ( p = 0.14 ) .
RESULTS	In the 1-mg/kg PSE group , there was a significant increase in peak systolic BP ( +10.6 mm Hg , p = 0.029 ) .
RESULTS	No significant changes occurred in peak diastolic BP ( +2.4 mm Hg , p = 0.333 ) , peak pulse ( +2.2 beats/min , p = 0.306 ) , peak RPE ( +0.2 , p = 0.62 ) , time to exhaustion ( +21.4 s , p = 0.289 ) , and VO2max ( +2.29 ml/kg/min , p = 0.31 ) .
RESULTS	In the 2-mg/kg PSE dose trial , there were insignificant changes in peak systolic BP of +2.4 mm Hg ( p = 0.559 ) , +3.8 mm Hg in peak diastolic BP ( p = 0.106 ) , +1.6 beats/min in peak pulse ( p = 0.586 ) , -0.1 in peak Borg RPE scales ( p = 0.76 ) , -10.4 s in time to exhaustion ( p = 0.41 ) , and +1.79 ml/kg/min in VO2max ( p = 0.43 ) .
RESULTS	Urine drug levels in those subjects receiving 1 mg/kg PSE ranged from 7-55 micrograms/ml before performance and 30-128 micrograms / ml after performance to 7-35 micrograms/ml the next morning .
RESULTS	Levels in those receiving 2 mg/kg ranged from 5-160 micrograms/ml before performance and 44-200 micrograms/ml after performance to 8-44 micrograms / ml the next day .
RESULTS	In the PPA 0.33-mg / kg dose trials , the levels ranged 1-36 micrograms/ml before performance and 9-50 micrograms/ml after performance to < 1-14 micrograms/ml the next morning .
RESULTS	In the PPA 0.66-mg / kg dose trials , the levels were 4-52 micrograms/ml before performance , 8-80 micrograms/ml after performance , and 6-74 micrograms/ml the next day .
CONCLUSIONS	We found no significant differences between trials in maximum oxygen uptake ( VO2max ) , peak or progression of Borg Scale ( RPE ) , maximum systolic and diastolic BPs , peak pulse , or t

###25773268
BACKGROUND	The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established .
BACKGROUND	We investigated the efficacy and safety of ticagrelor , a P2Y12 receptor antagonist with established efficacy after an acute coronary syndrome , in this context .
METHODS	We randomly assigned , in a double-blind 1:1:1 fashion , 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily , ticagrelor at a dose of 60 mg twice daily , or placebo .
METHODS	All the patients were to receive low-dose aspirin and were followed for a median of 33 months .
METHODS	The primary efficacy end point was the composite of cardiovascular death , myocardial infarction , or stroke .
METHODS	The primary safety end point was Thrombolysis in Myocardial Infarction ( TIMI ) major bleeding .
RESULTS	The two ticagrelor doses each reduced , as compared with placebo , the rate of the primary efficacy end point , with Kaplan-Meier rates at 3 years of 7.85 % in the group that received 90 mg of ticagrelor twice daily , 7.77 % in the group that received 60 mg of ticagrelor twice daily , and 9.04 % in the placebo group ( hazard ratio for 90 mg of ticagrelor vs. placebo , 0.85 ; 95 % confidence interval [ CI ] , 0.75 to 0.96 ; P = 0.008 ; hazard ratio for 60 mg of ticagrelor vs. placebo , 0.84 ; 95 % CI , 0.74 to 0.95 ; P = 0.004 ) .
RESULTS	Rates of TIMI major bleeding were higher with ticagrelor ( 2.60 % with 90 mg and 2.30 % with 60 mg ) than with placebo ( 1.06 % ) ( P < 0.001 for each dose vs. placebo ) ; the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63 % , 0.71 % , and 0.60 % , respectively .
CONCLUSIONS	In patients with a myocardial infarction more than 1 year previously , treatment with ticagrelor significantly reduced the risk of cardiovascular death , myocardial infarction , or stroke and increased the risk of major bleeding .
CONCLUSIONS	( Funded by AstraZeneca ; PEGASUS-TIMI 54 ClinicalTrials.gov number , NCT01225562 . )

###25909969
BACKGROUND	The administration of uterotonic agents during cesarean delivery is highly variable .
BACKGROUND	The authors hypothesized a `` rule of threes '' algorithm , featuring oxytocin 3 IU , timed uterine tone evaluations , and a systematic approach to alternative uterotonic agents , would reduce the oxytocin dose required to obtain adequate uterine tone .
METHODS	Sixty women undergoing elective cesarean delivery were randomized to receive a low-dose bolus or continuous infusion of oxytocin .
METHODS	To blind participants , the rule group simultaneously received intravenous oxytocin ( 3 IU/3 ml ) and a `` wide-open '' infusion of 0.9 % normal saline ( 500 ml ) ; the standard care group received intravenous 0.9 % normal saline ( 3 ml ) and a `` wide-open '' infusion of oxytocin ( 30 IU in 0.9 % normal saline/500 ml ) .
METHODS	Uterine tone was assessed at 3 , 6 , 9 , and 12 min , and if inadequate , additional uterotonic agents were administered .
METHODS	Uterine tone , total dose and timing of uterotonic agent use , maternal hemodynamics , side effects , and blood loss were recorded .
RESULTS	Adequate uterine tone was achieved with lower oxytocin doses in the rule versus standard care group ( mean , 4.0 vs. 8.4 IU ; point estimate of the difference , 4.4 1.0 IU ; 95 % CI , 2.60 to 6.15 ; P < 0.0001 ) .
RESULTS	No additional oxytocin or alternative uterotonic agents were needed in either group after 6 min .
RESULTS	No differences in the uterine tone , maternal hemodynamics , side effects , or blood loss were observed .
CONCLUSIONS	A `` rule of threes '' algorithm using oxytocin 3 IU results in lower oxytocin doses when compared with continuous-infusion oxytocin in women undergoing elective cesarean delivery .

###20629547
BACKGROUND	Gingival recession remains an important problem in dental esthetics .
BACKGROUND	A new dermal matrix material has been introduced , but its effectiveness has not been studied and compared to current dermal matrix material .
BACKGROUND	The aim of this study is to compare the healing associated with a coronally advanced flap for root coverage in areas of localized tissue recession when using Alloderm ( ADM ) and Puros Dermis ( PDM ) .
METHODS	A split-mouth design was used for this study , with 52 contralateral sites in 14 patients with Miller Class I or III facial tissue recession .
METHODS	Twenty-six sites were treated with coronally advanced flap using PDM , and 26 sites were treated with coronally advanced flap using ADM , all followed for 6 months .
METHODS	Clinical measurements of vertical recession , keratinized tissue , probing depths , and attachment levels were made initially , at 3 months , and at 6 months .
RESULTS	Both groups had significant improvement in the amount of recession coverage with means of 2.83 mm for the PDM and 3.13 mm for the ADM. The percentage of root coverage was 81.4 % for the PDM and 83.4 % for the ADM ; differences between the materials were not statistically significant .
CONCLUSIONS	Based on the results of this study , there was no statistical or clinical difference in the amount of root coverage , probing depth , or keratinized tissue in coronally advanced flaps for root coverage with either of the two acellular dermal matrix materials .
CONCLUSIONS	Both materials were successful in achieving root coverage .

###25332467
BACKGROUND	Utilization of energy-dense lipid fuels is critical to the rapid development and growth of neonates .
OBJECTIVE	To increase efficiency of milk fat utilization by newborn pigs , the effect of clofibrate on in vivo and in vitro long-chain fatty acid ( LCFA ) oxidation was evaluated .
METHODS	Newborn male pigs were administered 5 mL of vehicle ( 2 % Tween 80 ) with or without clofibrate ( 75 mg/kg body weight ) once daily via i.g. gavage for 4 d. Total LCFA oxidative capacity was measured in respiration chambers after gastric infusion ( n = 5 per treatment ) with isoenergetic amounts of [ 1 - ( 14 ) C ] triglycerides ( TGs ) , either oleic acid ( 18:1 n-9 ) TG [ 3.02 mmol/kg body weight ( BW ) ( 0.75 ) ] or erucic acid ( 22:1 n-9 ) TG ( 2.46 mmol/kg BW ( 0.75 ) ) .
METHODS	Total expired ( 14 ) CO2 was collected and quantified at 20-min intervals over 24 h. Hepatic in vitro LCFA oxidation was determined simultaneously using [ 1 - ( 14 ) C ] oleic acid and erucic acid substrates .
RESULTS	The in vivo 24-h accumulative [ 1 - ( 14 ) C ] TG oxidation ( percentage of energy intake/kg BW ( 0.75 ) ) tended to increase with clofibrate supplementation ( P = 0.10 ) , although there was no difference in the peak or mean utilization rate .
RESULTS	The maximal extent of oleic acid TG oxidation was 1.6-fold that of erucic acid TG ( P < 0.006 ) .
RESULTS	Hepatic in vitro LCFA oxidation increased 61 % with clofibrate ( P < 0.0008 ) .
RESULTS	The increase in mitochondria was 4-fold greater than in peroxisomes .
RESULTS	The relative abundance of mRNA increased 2 - to 3-fold for hepatic peroxisome proliferator-activated receptor and its target genes ( fatty acyl-coenzyme A oxidase and carnitine palmitoyltransferase ) in the pigs that were administered clofibrate ( P < 0.04 ) .
CONCLUSIONS	Clofibrate may improve in vivo LCFA oxidative utilization in neonatal pigs .

###12819524
OBJECTIVE	The adjustment of parents living with HIV ( PLH ) and their adolescent children was examined over 4 years in response to an intervention .
OBJECTIVE	Outcomes at 2 years had been previously published .
METHODS	A randomized controlled trial was conducted , with a representative sample from New York City .
RESULTS	In the intervention condition , fewer adolescents became teenage parents , and conduct problems tended to be lower over 4 years than in the standard care condition .
RESULTS	Fewer parents were drug dependent and tended to relapse into substance use or use passive coping styles compared with the standard care condition over 4 years .
RESULTS	The time-trend analysis showed that the significant reductions in problem behaviors and emotional distress previously observed over 15-24 months in the intervention condition , then eroded over time and were non-significant at 48 months .
CONCLUSIONS	Ongoing support and skills are needed to maintain intervention effects over longer periods .

###9366661
BACKGROUND	This experiment evaluated the effectiveness of an innovative program of assertive community treatment ( ACT ) for homeless persons with severe and persistent mental illnesses .
METHODS	One hundred fifty-two homeless persons with severe and persistent mental illness were randomized to either the experimental ACT program or to usual community services .
METHODS	Baseline assessments included the Structured Clinical Interview for DSM-III-R , Quality-of-Life Interview , Colorado Symptom Index , and the Medical Outcomes Study 36-Item Short Form Health Survey .
METHODS	All assessments ( except the Structured Clinical Interview ) were repeated at the 2 - , 6 - , and 12-month follow-up evaluations .
RESULTS	Subjects in the ACT program used significantly fewer psychiatric inpatient days , fewer emergency department visits , and more psychiatric outpatient visits than the comparison subjects .
RESULTS	The ACT subjects also spent significantly more days in stable community housing , and they experienced significantly greater improvements in symptoms , life satisfaction , and perceived health status .
CONCLUSIONS	Relative to usual community care , the ACT program for homeless persons with severe and persistent mental illness shifts the locus of care from crisis-oriented services to ongoing outpatient care and produces better housing , clinical , and life satisfaction outcomes .

###21167587
OBJECTIVE	To characterize the stress induced deformation of bi-axial flexure strength ( BFS ) test specimens during processing to provide an insight into sintering effects and associated BFS determination .
METHODS	40 Vitadur-Alpha and 80 IPS e.max Ceram disc-shaped specimens were condensed and a sintered on a silicon nitride refractory tray under controlled firing and cooling parameters .
METHODS	The mean of the maximum deflection ( m ) and Ra values ( m ) were determined using a high resolution profilometer and were related to the orientation of the measured surface within the furnace .
METHODS	BFS testing of the subsequent groups ( n = 20 ) was performed and the data related to the measured deformation of the sintered specimens .
METHODS	A two-way analysis of variance ( ANOVA ) where factors were identified as surface state and firing orientation with post hoc Tukey 's tests was complemented by pair-wise comparisons with a Student 's t-test for each measurement ( P < 0.05 ) .
RESULTS	The mean of the maximum deflection values and the mean BFS for Vitadur Alpha discs were not significantly influenced by firing orientation ( P = 0.248 and P = 0.284 , respectively ) .
RESULTS	However , the Ra values were significantly different ( P < 0.001 ) .
RESULTS	The two-way ANOVA revealed a significant impact on the mean of the maximum deflection measurements for surface state ( P < 0.001 ) and firing orientation ( P < 0.001 ) during sintering ( P < 0.001 ) .
RESULTS	The mean Ra values were not significantly influenced .
RESULTS	The BFS of sintered IPS e.max Ceram discs was sensitive to firing orientation ( P < 0.001 ) .
CONCLUSIONS	Conventional glass theory explains that residual thermal stress gradients induced during sintering can cause test specimen deformation which can alter the expected BFS data .
CONCLUSIONS	The study demonstrates that variability such as firing orientation during sintering which is very rarely reported in the literature can have a significant impact on the reported BFS data and can confound its interpretation .

###21674151
BACKGROUND	This dose-effect study extends previous observations showing that psilocybin can occasion mystical-type experiences having persisting positive effects on attitudes , mood , and behavior .
OBJECTIVE	This double-blind study evaluated psilocybin ( 0 , 5 , 10 , 20 , 30 mg/70 kg , p.o. ) administered under supportive conditions .
METHODS	Participants were 18 adults ( 17 hallucinogen-nave ) .
METHODS	Five 8-h sessions were conducted individually for each participant at 1-month intervals .
METHODS	Participants were randomized to receive the four active doses in either ascending or descending order ( nine participants each ) .
METHODS	Placebo was scheduled quasi-randomly .
METHODS	During sessions , volunteers used eyeshades and were instructed to direct their attention inward .
METHODS	Volunteers completed questionnaires assessing effects immediately after and 1 month after each session , and at 14 months follow-up .
RESULTS	Psilocybin produced acute perceptual and subjective effects including , at 20 and/or 30 mg/70 kg , extreme anxiety/fear ( 39 % of volunteers ) and/or mystical-type experience ( 72 % of volunteers ) .
RESULTS	One month after sessions at the two highest doses , volunteers rated the psilocybin experience as having substantial personal and spiritual significance , and attributed to the experience sustained positive changes in attitudes , mood , and behavior , with the ascending dose sequence showing greater positive effects .
RESULTS	At 14 months , ratings were undiminished and were consistent with changes rated by community observers .
RESULTS	Both the acute and persisting effects of psilocybin were generally a monotonically increasing function of dose , with the lowest dose showing significant effects .
CONCLUSIONS	Under supportive conditions , 20 and 30 mg/70 kg psilocybin occasioned mystical-type experiences having persisting positive effects on attitudes , mood , and behavior .
CONCLUSIONS	Implications for therapeutic trials are discussed .

###15663222
OBJECTIVE	To compare the activity of antihistamines by the index of area under dose-response curve ( AUDRC ) obtained from histamine-induced wheal and flare reactions .
METHODS	Mizolastine 10 mg , loratadine 10 mg , and placebo were given to 90 healthy volunteers and 60 allergic patients in a double-blind and randomized manner .
METHODS	Histamine titration tests ( histamine concentrations 54.3 , 20.0 , 7.3 , and 2.7 mmol/L ) were performed for each one before dosing and 2 , 4 , and 24 hours after dosing .
METHODS	The reactivity was evaluated by histamine-induced wheal and flare areas .
METHODS	The AUDRC values of the wheal and flare areas as a function of the natural logarithm transformed histamine concentration were calculated for each subject , and compared .
RESULTS	There was no significant difference of the wheal and flare areas between health volunteers and allergic patients .
RESULTS	The AUDRC ( 27-54 .3 mmol/l . )
RESULTS	for wheal and flare of mizolastine was 115.7 , 23.4 , 7.7 , 49.8 and 902.1 , 40.9 , 2.6 , 46.9 ln ( mmol/L ) x mm2 at each time ( before dosing and 2 , 4 , 24 hours after dosing ) respectively .
RESULTS	Compared with loratadine [ 116.2 , 80.2 , 49.7 , 71.9 and 957.6 , 495.3 , 153.5 , 205.9 ln ( mmol/L ) x mm2 ] , mizolastine decreased AUDRC ( 2.7 - 54.3 mmol/L significantly ( P < 0.01 ) .
CONCLUSIONS	Histamine-induced wheal and flare inhibition test is a reliable pharmacodynamic model for antihistamines , and AUDRC may be an useful index to predict antihistamines pharmacodynamic activity .

###19696704
OBJECTIVE	To evaluate the analgesic effect of 200 microg oral transmucosal fentanyl citrate during peripheral retinal scatter photocoagulation and to determine the side effect profile .
METHODS	A prospective , randomized , double-masked crossover study .
METHODS	Consecutive patients ( n = 35 ) undergoing peripheral retinal scatter photocoagulation were randomized into 2 groups .
METHODS	Each attended twice , 1 week apart , and received a standardized laser treatment at each visit .
METHODS	Group one received 200 microg oral transmucosal fentanyl citrate at Visit 1 and placebo at Visit 2 .
METHODS	Group 2 received the lozenges in reverse order .
METHODS	After each visit , each patient completed a 100-mm visual analog scale pain score and rating scale regarding systemic side effects .
RESULTS	The mean visual analog scale for patients receiving placebo was 36.4 ( SD , 31.5 ) .
RESULTS	The mean visual analog scale for patients receiving 200 microg oral transmucosal fentanyl citrate was 19.2 ( SD , 20.5 ) ( P = 0.0014 ) .
RESULTS	Overall , 4 patients ( 11 % ) reported moderate or severe adverse systemic side effects .
RESULTS	No clinically significant changes in systemic observations or adverse events occurred .
CONCLUSIONS	OTFC at a dosage of 200 microg is an effective and convenient analgesic for use in peripheral retinal scatter photocoagulation .
CONCLUSIONS	We found this agent to be well tolerated in the outpatient setting .
CONCLUSIONS	However , a larger study would be required to ascertain safety across a larger population of opiate-naive patients .

###8842609
OBJECTIVE	To determine whether the abnormal glucagon and amylin secretions in NIDDM are secondary to hyperglycemia and relative hypoinsulinemia .
METHODS	A total of 13 patients with NIDDM were studied before and after treatment with glipizide gastrointestinal therapeutic system ( GITS ) in a randomized double-blind placebo-controlled fashion .
METHODS	Of the 13 subjects , 9 were randomized to the glipizide GITS arm and 4 were randomized to the placebo arm of the study .
METHODS	Serum glucose , insulin , C-peptide , plasma glucagon , and plasma amylin concentrations were measured under fasting and postprandial ( post-Sustacal ingestion ) conditions .
METHODS	The Sustacal challenge was performed at baseline and after 12 weeks of treatment with either glipizide GITS or placebo .
RESULTS	Glipizide GITS treatment resulted in a significant reduction in hyperglycemia and increases in insulin and C-peptide secretion .
RESULTS	Hyperglucagonemia was not ameliorated , and amylin secretion was not altered after glipizide GITS treatment .
RESULTS	Placebo-treated patients did not show significant changes in any of the parameters measured .
CONCLUSIONS	Glipizide GITS treatment failed to ameliorate the hyperglucagonemia of NIDDM and did not alter amylin secretion even though it increased insulin secretion and significantly ameliorated the hyperglycemia .
CONCLUSIONS	These observations suggest that NIDDM related abnormalities in some of the islet cell hormonal responses are the result of changes inherent in the islet cells and may be independent of hyperglycemia and relative hypoinsulinemia .

###17073895
OBJECTIVE	Determine whether there are changes in visual functioning , vision-related disability , health status and mood after cataract surgery .
METHODS	45 adults ( mean age = 73.7 years ) with bilateral cataract needing surgery for the first eye were recruited from public ophthalmology clinics .
METHODS	The Visual Functioning-14 survey assessed visual disability .
METHODS	Minimal angle of resolution tested visual acuity , and the Melbourne Edge Test examined contrast sensitivity .
METHODS	Demographic , psychological , health and medication use variables were examined .
METHODS	Participants were randomized to either an intervention or control arm .
METHODS	Controls were assessed on two occasions at a 3-month interval before having surgery .
METHODS	The intervention group was assessed 1-2 weeks before surgery and then reassessed 3 months after surgery .
RESULTS	Visual functioning improved for those who had cataract surgery with better visual acuity in the better ( P = 0.010 ) and worse ( P = 0.028 ) eye compared with controls .
RESULTS	The intervention group reported fewer difficulties with overall vision-related disability ( P = 0.0001 ) , reading ( P = 0.004 ) and instrumental activities of daily living ( P = 0.010 ) post-surgery compared with controls .
RESULTS	People with improved depression scores ( P = 0.048 ) after surgery had less difficulty with reading compared with those with unchanged or worsened depression scores .
RESULTS	Cataract surgery did not improve health status .
CONCLUSIONS	First eye cataract surgery is effective in improving outcomes in visual functioning and disability .
CONCLUSIONS	Improved mood after surgery was related to less vision-related disability compared with unchanged or worse depression .

###24501379
BACKGROUND	Individuals with a strong family history of colorectal cancer have significant risk for colorectal cancer , although adherence to colonoscopy screening in these groups remains low .
BACKGROUND	This study assessed whether a tailored telephone counseling intervention can increase adherence to colonoscopy in members of high-risk families in a randomized , controlled trial .
METHODS	Eligible participants were recruited from two national cancer registries if they had a first-degree relative with colorectal cancer under age 60 or multiple affected family members , which included families that met the Amsterdam criteria for hereditary non-polyposis colon cancer ( HNPCC ) , and if they were due for colonoscopy within 24 months .
METHODS	Participants were randomized to receive a tailored telephone intervention grounded in behavioral theory or a mailed packet with general information about screening .
METHODS	Colonoscopy status was assessed through follow-up surveys and endoscopy reports .
METHODS	Cox proportional hazards models were used to assess intervention effect .
RESULTS	Of the 632 participants ( ages 25-80 ) , 60 % were female , the majority were White , non-Hispanic , educated , and had health insurance .
RESULTS	Colonoscopy adherence increased 11 percentage points in the tailored telephone intervention group , compared with no significant change in the mailed group .
RESULTS	The telephone intervention was associated with a 32 % increase in screening adherence compared with the mailed intervention ( HR , 1.32 ; P = 0.01 ) .
CONCLUSIONS	A tailored telephone intervention can effectively increase colonoscopy adherence in high-risk persons .
CONCLUSIONS	This intervention has the potential for broad dissemination to healthcare organizations or other high-risk populations .
CONCLUSIONS	Increasing adherence to colonoscopy among persons with increased colorectal cancer risk could effectively reduce incidence and mortality from this disease .

###21533969
BACKGROUND	Several studies have shown that nonfixation of mesh in total extraperitoneal ( TEP ) inguinal hernia repair is safe and has no disadvantage compared to mesh fixation in terms of recurrence rate , pain scores , and other morbidity parameters .
BACKGROUND	The aim of this study was to compare the effect of nonfixation of mesh with fixation in laparoscopic TEP inguinal hernia repair in a rural hospital in India .
METHODS	One hundred four patients were randomized to mesh nonfixation group or a fixation group during TEP .
METHODS	The postoperative pain scores on a visual analog scale ( VAS ) at 24 h , 1 week , 1 month , and 1 year , urinary retention , seroma formation , length of hospital stay , days taken to resume normal activities , and recurrence after 2 years were analyzed .
METHODS	The trial was registered at www.clinicaltrials.gov ( ID : NCT01117337 ) .
RESULTS	One hundred four patients ( 194 hernias ) were randomized to mesh nonfixation or fixation .
RESULTS	The pain scores at 24 h were comparable ( Fix , 1.31 0.4 ; Nonfix , 1.42 0.5 , P = 0.23 ) .
RESULTS	The length of hospital stay ( Fix , 1.12 0.3 days ; Nonfix , 1.15 0.4 days , P = 0.7 ) and days taken to resume normal activities ( Fix , 7.77 1.3 days ; Nonfix , 7.96 1.15 days , P = 0.44 ) were also similar for both groups .
RESULTS	The mean pain scores at 1 week ( Fix , 1.25 0.5 ; Nonfix , 1.34 0.6 , P = 0.42 ) , 1 month ( Fix , 1.06 0.2 ; Nonfix , 1.17 0.4 , P = 0.12 ) , 1 year ( Fix , 1.04 0.2 ; Nonfix , 1.13 0.4 , P = 0.11 ) , and 2 years ( Fix , 1.03 0.2 ; Nonfix , 1.0 , P = 0.17 ) were comparable for both groups .
RESULTS	There was no recurrence in either group at a minimum follow-up of 2 years .
CONCLUSIONS	There was no significant difference between fixation and nonfixation of mesh in TEP inguinal hernia repair with respect to postoperative pain , length of hospital stay , resumption of normal activities , seroma formation , and recurrence rate .
CONCLUSIONS	Nonfixation of mesh is safe and recommended in TEP inguinal hernia repair when done by an experienced surgeon , even in a rural setting .
CONCLUSIONS	The study highlights the potential for universal application of the procedure .

###15706558
OBJECTIVE	To investigate the effects of whole body vibration in the elderly .
METHODS	Randomized controlled trial .
METHODS	Nursing home .
METHODS	Forty-two elderly volunteers .
METHODS	Six-week vibration intervention plus physical therapy ( PT ) ( n = 22 ) or PT alone ( n = 20 ) .
METHODS	We assessed gait and body balance using the Tinetti test ( maximum scores of 12 for gait , 16 for body balance , 28 for global score ) , motor capacity using the Timed Up & Go ( TUG ) test , and health-related quality of life ( HRQOL ) using the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) .
RESULTS	After 6 weeks , the vibration intervention group improved by a mean + / - standard deviation of 2.4 + / -2.3 points on the gait score compared with no score change in the control group ( P < .001 ) .
RESULTS	The intervention group improved by 3.5 + / -2.1 points on the body balance score compared with a decrease of 0.3 + / -1.2 points in the control group ( P < .001 ) .
RESULTS	TUG test time decreased by 11.0 + / -8.6 seconds in the treated group compared with an increase of 2.6 + / -8.8 seconds in the control group ( P < .001 ) .
RESULTS	The intervention group had significantly greater improvements from baseline on 8 of 9 items on the SF-36 compared with the control group .
CONCLUSIONS	Controlled whole body vibration can improve elements of fall risk and HRQOL in elderly patients .

###23412407
BACKGROUND	We hypothesized that minimally invasive surgery was superior to conventional surgery for total hip arthroplasty procedure .
OBJECTIVE	To compare the results of total hip replacement ( THR ) made by minimally invasive lateral approach with the results of THR made by conventional lateral approach .
METHODS	Prospective , randomized trial .
METHODS	Fifty patients were selected and then divided into two groups based on utilized approach .
METHODS	Perioperative bleeding , postoperative pain , time of recovery , components orientation , complications and functional results .
METHODS	Five-year follow-up .
RESULTS	No differences were found in blood loss , postoperative pain , surgical time , components orientation , rate of complications or functional result .
RESULTS	Minimally invasive lateral approach produced faster recovery with less hospital stay and earlier walking start .
CONCLUSIONS	Our results suggested that minimally invasive lateral approach has not provided significant benefits over conventional lateral approach for the implantation of a total hip arthroplasty .

###17406133
BACKGROUND	We examined male circumcision outcomes among young adults in an African setting .
METHODS	Participants were healthy , sexually active , uncircumcised , HIV-seronegative males aged 18-24 years .
METHODS	The main outcomes measured included complications , healing , satisfaction and resumption of activities .
RESULTS	Of 1,475 procedures , 26 ( 1.8 % ) were associated with 27 adverse events , most commonly wound disruption/delayed healing ( 0.6 % ) , wound infection ( 0.4 % ) , and bleeding ( 0.3 % ) .
RESULTS	Adverse events per clinician averaged 3.8 and 2.1 % for procedures 1-100 and 101-200 , respectively , and < 1 % for procedures 201-300 , 301-400 and > 400 , respectively ( p < 0.001 ) .
RESULTS	Participants resumed normal general activities after a median of 1 postoperative day and 93 % with regular employment resumed working within 1 week .
RESULTS	After 30 days , 99 % of participants reported being very satisfied .
RESULTS	After 90 days , 65 % reported having had sex , 45 % reported that their partners had expressed an opinion , 92 % of whom were very satisfied with the outcome .
CONCLUSIONS	Safe and acceptable adult male circumcision services can be delivered in developing country settings .

###11519238
OBJECTIVE	To examine prenatal , maternal , and infant outcomes and costs through 1 year after delivery using a model of prenatal care for women at high risk of delivering low-birth-weight infants in which half of the prenatal care was provided in women 's homes by nurse specialists with master 's degrees .
METHODS	Randomized clinical trial .
METHODS	A sample of 173 women ( and 194 infants ) with high-risk pregnancies ( gestational or pregestational diabetes mellitus , chronic hypertension , preterm labor , or high risk of preterm labor ) were randomly assigned to the intervention group ( 85 women and 94 infants ) or the control group ( 88 women and 100 infants ) .
METHODS	Control women received usual prenatal care .
METHODS	Intervention women received half of their prenatal care in their homes , with teaching , counseling , telephone outreach , daily telephone availability , and a postpartum home visit by nurse specialists with physician backup .
RESULTS	For the full sample , mean maternal age was 27 years ; 85.5 % of women were single mothers , 36.4 % had less than a high school education , 93.6 % were African American , and 93.6 % had public health insurance , with no differences between groups on these variables .
RESULTS	The intervention group had lower fetal/infant mortality vs the control group ( 2 vs 9 ) , 11 fewer preterm infants , more twin pregnancies carried to term ( 77.7 % vs 33.3 % ) , fewer prenatal hospitalizations ( 41 vs 49 ) , fewer infant rehospitalizations ( 18 vs 24 ) , and a savings of more than 750 total hospital days and $ 2,496,145 [ corrected ] .
CONCLUSIONS	This model of care provides a reasoned solution to improving pregnancy and infant outcomes while reducing healthcare costs .

###17101847
BACKGROUND	Selectivity , titratability , rapidity of onset , and active reversibility are desirable pharmacological properties of anticoagulant therapy administered for acute indications and collectively represent an attractive platform to maximize patient safety .
BACKGROUND	A novel anticoagulation system ( REG1 , Regado Biosciences ) , developed using a protein-binding oligonucleotide to factor IXa ( drug , RB006 ) and its complementary oligonucleotide antidote ( RB007 ) , was evaluated in healthy volunteers .
BACKGROUND	The primary objective was to determine the safety profile and to characterize the pharmacodynamic responses in this first-in-human study .
RESULTS	Regado 1a was a subject-blinded , dose-escalation , placebo-controlled study that randomized 85 healthy volunteers to receive a bolus of drug or placebo followed 3 hours later by a bolus of antidote or placebo .
RESULTS	Pharmacodynamic samples were collected serially .
RESULTS	Subject characteristics were the following : median age , 32 years ( interquartile range , 23 to 39 years ) ; female gender , 35 % ; and median weight , 79 kg ( interquartile range , 70 to 87 kg ) .
RESULTS	No significant differences were found in median hemoglobin , platelet , creatinine , or liver function studies .
RESULTS	There were no significant bleeding signals associated with RB006 , and overall , both drug and antidote were well tolerated .
RESULTS	One serious adverse event , an episode of transient encephalopathy , occurred in a subject receiving the low intermediate dose of RB006 .
RESULTS	The subject 's symptoms resolved rapidly , and no further sequelae occurred .
RESULTS	A predictable dose-pharmacodynamic response , reflected in activated partial thromboplastin time measurements , was seen after administration of the bolus of drug , with a clear correlation between the peak posttreatment activated partial thromboplastin time and post hoc weight-adjusted dose of drug ( correlation coefficient , 0.725 ; P < 0.001 ) .
RESULTS	In subjects treated with drug , antidote administration reversed the pharmacological activity of the drug , with a rapid ( mean time , 1 to 5 minutes across all dose levels ) and sustained return of activated partial thromboplastin time to within the normal range .
RESULTS	The activated clotting time followed a similar anticoagulant response and reversal pattern .
RESULTS	As anticipated , prothrombin time remained unchanged compared with baseline .
CONCLUSIONS	These observations represent a first-in-human experience of an RNA aptamer and its complementary oligonucleotide antidote used as an anticoagulant system .
CONCLUSIONS	The findings contribute to an emerging platform of selective , actively reversible anticoagulant drugs for use among patients with thrombotic disorders of the venous and arterial circulations .

###9443116
BACKGROUND	Highly bioavailable dietary iron is needed to ensure optimal iron status in infants during weaning .
BACKGROUND	The purpose of the current study was to examine the effect of increased meat intake on hemoglobin concentration ( Hb ) , serum ferritin ( SF ) , and serum transferrin receptors ( TfR ) in late infancy .
METHODS	Forty-one healthy , term , partially breast-fed 8-month-old infants were randomized into two groups : a low-meat group ( LMG ) , in which infants received a diet with a mean meat content of 10 g/day and a high-meat group ( HMG ) , in which infants received a diet with a mean meat content of 27 g/day .
METHODS	The intervention lasted for 2 months , and blood samples were drawn on the first and the last days of the intervention .
RESULTS	At the beginning of the intervention , no significant differences were found in Hb , SF , TfR values between the two groups .
RESULTS	After the intervention , there was a significant ( p = 0.008 ) difference in the change in hemoglobin ( delta Hb ) concentration .
RESULTS	In the LMG delta Hb was -4.9 g/l ( range , -12.9 -5.6 g/l ) and in the HMG -0.6 g/l ( range , -12.1 -7.3 g/l ) .
RESULTS	There was no significant difference in change in SF or TfR concentrations between the LMG and the HMG .
RESULTS	The intake of iron from meat ( mean ; range ) was significantly higher ( p = 0.0001 ) in the HMG ( 0.4 mg/day ; 0.02-0 .7 mg/day ) than in the LMG ( 0.1 mg/day ; 0.03-0 .5 mg/day ) .
RESULTS	However , there was no significant difference in total iron intake between the HMG ( 3.1 mg/day ; 0.4-6 .2 mg/day ) and the LMG ( 3.4 mg/day ; 1.4-6 .1 mg/day ) .
CONCLUSIONS	The results suggest that an increase in meat intake can prevent a decrease in Hb in late infancy , probably by enhancing iron absorption .
CONCLUSIONS	However , there was no effect on iron stores or on cellular iron deficiency , evaluated by SF and TfR levels , respectively .

###21255776
OBJECTIVE	To identify a potential diagnostic endometriosis marker using matrix-enhanced laser desorption/ionization time-of-flight mass spectrometry ( MALDI-TOF-MS ) - based urinary proteomics .
METHODS	Prospective randomized pilot study .
METHODS	University hospital , tertiary referral center for endometriosis .
METHODS	53 women undergoing laparoscopic surgery for pain and/or infertility comprising 30 women without endometriosis and 23 with endometriosis .
METHODS	Laparoscopy and urine specimens .
METHODS	Urinary peptide profiles .
RESULTS	We observed distinct patterns of peptide profiles in the urine samples of women presenting with typical clinical symptoms of endometriosis .
RESULTS	Six statistically significant putative peptide markers were identified ( four during the periovulatory phase and two during the luteal phase ) by comparing controls with moderate/severe endometriosis patients .
RESULTS	The periovulatory peptide mass of 1,767.1 Da and the luteal peptide mass of 1,824.3 Da both showed a sensitivity of 75 % and a specificity of 85 % and 71 % , respectively .
RESULTS	Also detected were seven peptide markers ( two during the periovulatory phase and five during the luteal phase ) by comparing the urinary peptide profiles of patients with minimal/mild to moderate/severe endometriosis .
RESULTS	The periovulatory peptide mass of 3,280.9 Da and the luteal peptide mass of 1,933.8 Da showed a sensitivity of 82 % and 75 % and a specificity of 88 % and 75 % , respectively .
CONCLUSIONS	Urinary proteomic analysis may provide a novel method of diagnosing and staging endometriosis .

###18218084
BACKGROUND	Decision aids can improve decision making processes , but the amount and type of information that they should attempt to communicate is controversial .
BACKGROUND	We sought to compare , in a pilot randomized trial , two colorectal cancer ( CRC ) screening decision aids that differed in the number of screening options presented .
METHODS	Adults ages 48-75 not currently up to date with screening were recruited from the community and randomized to view one of two versions of our previously tested CRC screening decision aid .
METHODS	The first version included five screening options : fecal occult blood test ( FOBT ) , sigmoidoscopy , a combination of FOBT and sigmoidoscopy , colonoscopy , and barium enema .
METHODS	The second discussed only the two most frequently selected screening options , FOBT and colonoscopy .
METHODS	Main outcomes were differences in screening interest and test preferences between groups after decision aid viewing .
METHODS	Patient test preference was elicited first without any associated out-of-pocket costs ( OPC ) , and then with the following costs : FOBT - $ 10 , sigmoidoscopy - $ 50 , barium enema - $ 50 , and colonoscopy - $ 200 .
RESULTS	62 adults participated : 25 viewed the 5-option decision aid , and 37 viewed the 2-option version .
RESULTS	Mean age was 54 ( range 48-72 ) , 58 % were women , 71 % were White , 24 % African-American ; 58 % had completed at least a 4-year college degree .
RESULTS	Comparing participants that viewed the 5-option version with participants who viewed the 2-option version , there were no differences in screening interest after viewing ( 1.8 vs. 1.9 , t-test p = 0.76 ) .
RESULTS	Those viewing the 2-option version were somewhat more likely to choose colonoscopy than those viewing the 5-option version when no out of pocket costs were assumed ( 68 % vs. 46 % , p = 0.11 ) , but not when such costs were imposed ( 41 % vs. 42 % , p = 1.00 ) .
CONCLUSIONS	The number of screening options available does not appear to have a large effect on interest in colorectal cancer screening .
CONCLUSIONS	The effect of offering differing numbers of options may affect test choice when out-of-pocket costs are not considered .

###16877650
OBJECTIVE	The authors compared the incremental cost-effectiveness of a stepped-care , multicomponent program with usual care for the treatment of depressed women in primary care in Santiago , Chile .
METHODS	A cost-effectiveness study was conducted of a previous randomized controlled trial involving 240 eligible women with DSM-IV major depression who were selected from a consecutive sample of adult women attending primary care clinics .
METHODS	The patients were randomly allocated to usual care or a multicomponent stepped-care program led by a nonmedical health care worker .
METHODS	Depression-free days and health care costs derived from local sources were assessed after 3 and 6 months .
METHODS	A health service perspective was used in the economic analysis .
RESULTS	Complete data were determined for 80 % of the randomly assigned patients .
RESULTS	After we adjusted for initial severity , women receiving the stepped-care program had a mean of 50 additional depression-free days over 6 months relative to patients allocated to usual care .
RESULTS	The stepped-care program was marginally more expensive than usual care ( an extra 216 Chilean pesos per depression-free day ) .
RESULTS	There was a 90 % probability that the incremental cost of obtaining an extra depression-free day with the intervention would not exceed 300 pesos ( 1.04 US dollars ) .
CONCLUSIONS	The stepped-care program was significantly more effective and marginally more expensive than usual care for the treatment of depressed women in primary care .
CONCLUSIONS	Small investments to improve depression appear to yield larger gains in poorer environments .
CONCLUSIONS	Simple and inexpensive treatment programs tested in developing countries might provide good study models for developed countries .

###9679845
BACKGROUND	Inhaled corticosteroids are increasingly being used to treat mild-to-moderate asthma in children .
BACKGROUND	However , data regarding therapy with this class of compounds , especially in children under age 6 years , is limited .
BACKGROUND	Fluticasone propionate is a third generation inhaled corticosteroid with an optimal therapeutic index .
BACKGROUND	Few large prospective clinical trials have been conducted to evaluate the efficacy and safety of fluticasone propionate powder in children .
OBJECTIVE	We sought to determine the efficacy and safety of fluticasone propionate powder administered by means of the Diskus and Diskhaler multidose powder inhalers in pediatric patients with persistent asthma .
METHODS	Fluticasone propionate powder ( 50 microg or 100 microg twice daily ) or placebo was administered by means of the Diskus or Diskhaler inhalers to 437 children ( 4 to 11 years old ) with persistent asthma for 12 weeks in a randomized , double-blind , parallel-group , multi-center trial .
METHODS	Patients were stratified according to whether they were receiving prior treatment with inhaled corticosteroids or cromolyn or beta2-agonists alone .
RESULTS	Fluticasone propionate powder administered by means of Diskus or Diskhaler significantly improved FEV1 ( mean increase from baseline of 0.22 to 0.24 L ; p < or = 0.023 ) , clinic morning peak expiratory flow ( mean increase from baseline of 48 to 55 L/min ; p < or = 0.006 ) , patient-measured morning ( p < or = 0.001 ) and evening ( p < or = 0.003 ) peak expiratory flow , and asthma symptom scores ( in all but the 50 microg Diskus group ; p < or = 0.036 ) , as well as reduced albuterol use ( p < or = 0.002 ) and nighttime awakenings ( p < or = 0.019 ) at endpoint .
RESULTS	Efficacy parameters were not significantly different between the two doses with either device .
RESULTS	More placebo-treated patients discontinued the study because of lack of efficacy than patients in any fluticasone propionate group ( p < 0.001 ) .
RESULTS	Fluticasone propionate did not suppress morning plasma cortisol concentrations and did not affect 24-hour urinary free-cortisol excretion .
RESULTS	Adverse events were primarily pharmacologic effects of inhaled corticosteroids , and those related to the study drug occurred with low frequency .
RESULTS	Patient satisfaction with both the Diskus and Diskhaler devices was high , with a majority of patients ( > 80 % ) rating them favorably .
CONCLUSIONS	This study demonstrated that fluticasone propionate powder , at the conventional recommended doses of up to 200 microg/day administered by means of Diskus or Diskhaler , was well tolerated and improved lung function in children even as young as 4 and 5 years old regardless of whether they were previously treated with inhaled corticosteroids or cromolyn or beta2-agonists alone .

###22039230
OBJECTIVE	To determine whether a novel optical treatment using contact lenses to reduce relative peripheral hyperopia can slow the rate of progress of myopia .
METHODS	Chinese children , aged 7 to 14 years , with baseline myopia from sphere -0.75 to -3.50 D and cylinder 1.00 D , were fitted with novel contact lenses ( n = 45 ) and followed up for 12 months , and their progress was compared with that of a group ( n = 40 ) matched for age , sex , refractive error , axial length , and parental myopia wearing normal , single-vision , spherocylindrical spectacles .
RESULTS	On adjusting for parental myopia , sex , age , baseline spherical equivalent ( SphE ) values , and compliance , the estimated progression in SphE at 12 months was 34 % less , at -0.57 D , with the novel contact lenses ( 95 % confidence interval [ CI ] , -0.45 -0.69 D ) than at -0.86 D , with spectacle lenses ( 95 % CI , -0.74 to -0.99 D ) .
RESULTS	For an average baseline age of 11.2 years , baseline SphE of -2.10 D , a baseline axial length of 24.6 mm , and 320 days of compliant lens wear , the estimated increase in axial length ( AL ) was 33 % less at 0.27 mm ( 95 % CI , 0.22-0 .32 mm ) than at 0.40 mm ( 95 % CI , 0.35-0 .45 mm ) for the contact lens and spectacle lens groups , respectively .
CONCLUSIONS	The 12-month data support the hypothesis that reducing peripheral hyperopia can alter central refractive development and reduce the rate of progress of myopia .
CONCLUSIONS	( chictr.org number , chiCTR-TRC-00000029 or chiCTR-TRC-00000032 . )

###12192167
OBJECTIVE	To evaluate the safety and immunogenicity of diphtheria-tetanus toxoids-acellular pertussis ( DTPa ) - hepatitis B ( HepB ) combination vaccine given at 2 , 4 and 6 months of age compared with monovalent HepB vaccine given at birth , 1 month and 6 months of age and DTPa vaccine given at 2 , 4 and 6 months of age .
METHODS	Healthy infants were randomized to receive a combination DTPa-HepB vaccine ( diphtheria and tetanus toxoids , acellular pertussis antigens and hepatitis B surface antigen ) , concomitantly with type b and oral poliovirus vaccines at 2 , 4 and 6 months of age ( Group 1 ) or HepB vaccine given at birth , 1 month and 6 months of age and DTPa , type b and oral poliovirus vaccines given at 2 , 4 and 6 months of age ( Group 2 ) .
METHODS	Antibody responses were evaluated at birth , 2 months and 7 months of age .
METHODS	Safety was evaluated after each immunization using diary cards and parental interviews .
RESULTS	One month after the third dose ( 7 months of age ) , the geometric mean concentration of antibody to hepatitis B surface antigen was approximately 3.5-fold higher in Group 2 than in Group 1 infants ( 3643 and 1052 mIU/ml , respectively ; < 0.001 ) .
RESULTS	Nevertheless the rates of seroprotection to HepB ( antibody to hepatitis B surface antigen > or = 10 mIU/ml ) in Groups 1 and 2 were similar , 99 and 100 % , respectively .
RESULTS	Also the postvaccination geometric mean concentrations and rates of seroprotection or vaccine response to all of the other vaccine antigens evaluated were similar or greater in Group 1 than in Group 2 .
RESULTS	The rates of adverse events were similar between the two groups , with fussiness and soreness at any injection site reported most frequently .
CONCLUSIONS	The DTPa-HepB combination vaccine was safe and immunogenic when given to infants at 2 , 4 and 6 months of age .
CONCLUSIONS	Equivalent rates of seroprotection to hepatitis B were achieved despite a reduction of the interval between the second and third doses from 5 months in Group 2 to 2 months in Group 1 .
CONCLUSIONS	Hepatitis B-containing combination vaccines should reduce the number of vaccine injections required in childhood and maintain excellent seroprotection against multiple pathogens .

###16254521
OBJECTIVE	To assess the safety of a polyethylene glycol ( PEG ) 4000 laxative without additional salts in pediatric patients .
METHODS	This was a 3-month multicenter , randomized , double-blind , double-dummy , lactulose-controlled , parallel study enrolling 96 ambulatory constipated children aged 6 months to 3 years , treated daily with 4-8 g PEG or 3.33 g-6 .66 g lactulose .
METHODS	Total protein , albumin , iron , electrolytes , and vitamins B9 ( folates ) , A and D ( 25OHD3 ) were measured in blood before and after treatment ( day 84 ) in a central laboratory .
RESULTS	The percentage of children with at least one value out of normal range at day 84 with respect to baseline status ( with or without at least one value out of normal range ) , i.e. the primary endpoint , was 87 % and 90 % in the PEG and lactulose groups , respectively , without any difference between groups .
RESULTS	The whole blood parameters showed no qualitative or quantitative treatment-related changes .
RESULTS	Vitamin A values were above normal range in 56 % and 41 % of children at baseline versus 33 % and 36 % at day 84 in the PEG and lactulose groups , respectively .
RESULTS	Iron values were similarly under normal range in 47 % and 51 % at baseline versus 42 % and 51 % at day 84 .
RESULTS	Clinical tolerance was similar for both treatments except for vomiting and flatulence , which were significantly higher with lactulose .
RESULTS	Significantly higher improvements were evidenced with PEG regarding stool consistency , appetite , fecaloma and use of additional laxatives .
CONCLUSIONS	This 3-month study in 96 constipated children aged 6 months to 3 years confirms the long-term tolerance of PEG 4000 in pediatrics and indicates a PEG efficacy similar to or greater than that of lactulose .

###23889837
BACKGROUND	There is conflicting evidence regarding the benefits of intensive speech and language therapy ( SLT ) , particularly because intensity is often confounded with total SLT provided .
OBJECTIVE	A two-centre , randomized , rater-blinded , parallel study was conducted to compare the efficacy of 100 h of SLT in a regular ( RT ) versus intensive ( IT ) treatment in sub-acute post-stroke aphasia .
METHODS	Consecutive patients with aphasia , within 3 months of a left hemisphere ischemic stroke , were randomized to IT ( 2 h per day 5 days per week , 10 weeks ) or RT ( 2 h per week 50 weeks ) .
METHODS	Evaluations took place at 10 , 50 and 62 weeks .
METHODS	Primary outcome was the frequency of responders , defined by 15 % increase of Aphasia Quotient ( AQ ) from the baseline to 50 weeks .
METHODS	Secondary outcomes were changes from the baseline in AQ and functional communication profile ( FCP ) at 50 and 62 weeks and improvement stability between 50 and 62 weeks .
RESULTS	Thirty patients were randomized and 18 completed the study .
RESULTS	No significant differences were found between groups in primary or secondary outcomes , although IT patients ( N = 9 ) obtained higher scores in language measures between 10 and 62 weeks in per protocol analysis .
RESULTS	The number of non-completions was identical between groups .
CONCLUSIONS	This study suggests that , in the sub-acute period following stroke and controlling for the number of hours of SLT provided , there is a trend for a greater improvement in language and functional communication measures with IT compared with RT. .
CONCLUSIONS	The lack of statistical significance in results was probably due to the small sample size .

###25494217
BACKGROUND	The acute respiratory distress syndrome ( ARDS ) is a common devastating syndrome in intensive care unit in critically ill patients .
BACKGROUND	Continuous renal replacement therapy ( CRRT ) has been shown beneficial effects on oxygenation and survival in patients with ARDS .
BACKGROUND	However , it is still controversial about the timing of initiation of CRRT .
METHODS	Fifty-three patients with ARDS admitted to intensive care unit in Zhejiang Provincial People 's Hospital , China from 2009 to 2013 were enrolled in the study .
METHODS	The authors compared ventilation parameter , including PaO2/FIO2 , A-a gradient , positive end-expiratory pressure , plateau pressure , dynamic compliance and hemodynamic parameters , including central venous pressure , mean arterial pressure , cardiac index , extravascular lung water index , fluid balance between early initiation ( within 12 hours after ARDS onset ) and late initiation of CRRT ( 48 hours after ARDS onset ) groups .
METHODS	The authors further investigated transforming growth factor ( TGF ) -1 level changes in serum and bronchoalveolar lavage fluid ( BALF ) by enzyme-linked immunosorbent assay during 7 days of follow-up .
RESULTS	Significant improvement of oxygenation and shorter duration of mechanical ventilation were observed in early CRRT group during 7-day follow-up .
RESULTS	In addition , TGF-1 concentrations in serum and BALF were significantly decreased in patients with early initiation of CRRT compared to those with late initiation of CRRT on day 2 and day 7 .
RESULTS	Furthermore , patients who died of ARDS had higher levels of TGF-1 in BALF than survivors .
CONCLUSIONS	Our findings showed that early initiation of CRRT is associated with favorable clinical outcomes in ARDS patients , which might be due to the reduced serum and BALF TGF-1 levels through CRRT .
CONCLUSIONS	However , large multi-center studies are needed to make further recommendations as to the optimal use of CRRT in ARDS patient populations .

###11464225
OBJECTIVE	To investigate the effects of increasing Cu intakes , above the usual dietary intake , on biomarkers of bone metabolism in healthy young adult females ( aged 21-28 y ) over a 4 week period .
METHODS	A double-blind , placebo-controlled randomised repeat crossover Cu supplementation trial .
METHODS	The study was conducted at the Royal Veterinary and Agricultural University ( RVAU ) , Copenhagen , Denmark .
METHODS	Sixteen healthy young adult females aged 20-28 y were recruited from among students at the RVAU .
METHODS	During the 4 week intervention periods in this randomised , crossover trial ( 3x4 weeks with a minimum 3 week wash-out period ) , each subject received , in addition to their usual diet , either 3 or 6 mg elemental Cu/day as CuSO4 or a matching placebo .
METHODS	On the last 3 days of each dietary period 24 h urines were collected .
METHODS	In addition , blood was collected on the last day of each dietary period .
RESULTS	Serum Cu and erythrocyte superoxide dismutase ( but not caeruloplasmin protein concentration or activity ( putative indices of Cu status ) ) were significantly increased ( P < 0.05 ) after daily Cu supplementation with 3 and 6 mg/day for 4 weeks .
RESULTS	Serum osteocalcin ( biomarker of bone formation ) , urinary creatinine ( Cr ) concentration , urinary pyridinoline ( Pyr ) / Cr or deoxypyridinoline ( Dpyr ) / Cr excretion , or daily urinary Pyr or Dpyr excretion ( biomarkers of bone resorption ) were unaffected by Cu supplementation .
CONCLUSIONS	Copper supplementation of the usual diet in healthy young adult females , while apparently improving Cu status , had no effect on biochemical markers of bone formation or bone resorption over 4 week periods .
BACKGROUND	Funding from the European Commission .

###24839882
OBJECTIVE	This study tested the effect of beginning treatment with a speech-generating device ( SGD ) in the context of a blended , adaptive treatment design for improving spontaneous , communicative utterances in school-aged , minimally verbal children with autism .
METHODS	A total of 61 minimally verbal children with autism , aged 5 to 8 years , were randomized to a blended developmental/behavioral intervention ( JASP+EMT ) with or without the augmentation of a SGD for 6 months with a 3-month follow-up .
METHODS	The intervention consisted of 2 stages .
METHODS	In stage 1 , all children received 2 sessions per week for 3 months .
METHODS	Stage 2 intervention was adapted ( by increased sessions or adding the SGD ) based on the child 's early response .
METHODS	The primary outcome was the total number of spontaneous communicative utterances ; secondary measures were the total number of novel words and total comments from a natural language sample .
RESULTS	Primary aim results found improvements in spontaneous communicative utterances , novel words , and comments that all favored the blended behavioral intervention that began by including an SGD ( JASP+EMT+SGD ) as opposed to spoken words alone ( JASP+EMT ) .
RESULTS	Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes .
CONCLUSIONS	Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel , blended intervention that focuses on joint engagement and play skills and incorporates an SGD .
CONCLUSIONS	Future studies should further explore the tailoring design used in this study to better understand children 's response to treatment .
CONCLUSIONS	Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language ( CCNIA ) ; http://clinicaltrials.gov/; NCT01013545 .

###18262655
BACKGROUND	Electroconvulsive therapy ( ECT ) has a long history of use in treating depression .
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) has been introduced more recently to the treatment spectrum .
BACKGROUND	Its cost-effectiveness has not been explored .
METHODS	Forty-six right-handed people with severe depressive episodes referred for ECT were randomised to receive either ECT twice weekly or rTMS on consecutive weekdays .
METHODS	Health and other service use were recorded for retrospective periods of 3 months prior to initiation of treatment and during the 6 months following the end of allocated treatment .
METHODS	Costs were calculated for the treatment period and the subsequent 6 months , and comparisons made between groups after adjustment for any baseline differences .
METHODS	Cost-effectiveness analysis was conducted with incremental change on the 17-item Hamilton Rating Scale for Depression ( HRSD ) as the primary outcome measure , and quality-adjusted life years ( based on SF6D-generated utility scores with societal weights ) as secondary outcome , cost-effectiveness acceptability curves plotted .
RESULTS	Based on the HRSD scores and other outcome measures , rTMS was not as effective as ECT .
RESULTS	The cost of a single session of rTMS was lower than the cost of a session of ECT , but overall there were no treatment cost differences .
RESULTS	In the treatment and 6-month follow-up periods combined , health and other service costs were not significantly different between the two groups .
RESULTS	Informal care costs were higher for the rTMS group .
RESULTS	Total treatment , service and informal care costs were also higher for the rTMS group .
RESULTS	The cost-effectiveness acceptability curves indicated a very small probability that decision-makers would view rTMS as more cost-effective than ECT .
CONCLUSIONS	Small sample size , some sample attrition and a relatively short follow-up period of 6 months for a chronic illness .
CONCLUSIONS	Productivity losses could not be calculated .
CONCLUSIONS	ECT is more cost-effective than rTMS in the treatment of severe depression .

###16804099
BACKGROUND	The management of patients who are receiving warfarin therapy and have musculoskeletal problems that require treatment with a nonsteroidal antiinflammatory drug ( NSAID ) is problematic because NSAID use may increase the risk for bleeding .
BACKGROUND	Cyclooxygenase-2 selective NSAIDs such as celecoxib may be less likely to promote gastrointestinal bleeding ; however , there are concerns that they could potentiate the anticoagulation effect of warfarin .
OBJECTIVE	To determine whether celecoxib potentiates the anticoagulant effect of warfarin , as measured by the international normalized ratio ( INR ) .
METHODS	We performed a randomized , controlled , crossover trial to assess the effect on INR of celecoxib versus codeine ( control treatment ) in 15 patients who were receiving warfarin therapy and required analgesic treatment for osteoarthritis .
METHODS	During Phase 1 of the study , patients were randomly allocated to receive celecoxib 200 mg/day or codeine phosphate 7-15 mg 3-4 times daily for 5 weeks .
METHODS	During Phase 2 of the study , patients stopped the first study medication and started the other study medication ; there was no drug-free interval between phases .
METHODS	Weekly INR testing was performed during the 10 week study period .
METHODS	Adopting the intent-to-treat principle , we used generalized estimating equations to analyze the data .
RESULTS	There was no significant difference in the mean INR values during each 5 week treatment period when patients received either celecoxib or codeine .
RESULTS	There was , therefore , insufficient evidence to reject the hypothesis that these 2 treatments had an equal effect on the INR ( mean difference [ 95 % CI ] 0.10 [ -0.04 to 0.24 ] ; p = 0.16 ) based on mean imputation .
RESULTS	This finding was confirmed after we repeated the analysis with multiple imputations ( mean difference [ 95 % CI ] 0.093 [ -0.16 to 0.35 ] ; p = 0.47 ) .
CONCLUSIONS	Our results suggest that treatment with celecoxib does not potentiate the INR when taken with warfarin .
CONCLUSIONS	Larger randomized trials are warranted to address the effects of coadministered warfarin and celecoxib on clinical outcomes .

###20955955
OBJECTIVE	The aim of this study was to compare GPX instruments and hand files for gutta-percha removal .
METHODS	Fifty maxillary central incisors with a single straight canal were instrumented and filled .
METHODS	The teeth were divided into 5 groups of 10 specimens each , according to the gutta-percha removal techniques : group 1 : GPX ( 21-mm-long teeth ) ; group 2 : GPX and xylol as solvent ( 21-mm-long teeth ) ; group 3 : GPX ( 25-mm-long teeth ) ; group 4 : GPX and xylol as solvent ( 25-mm-long teeth ) ; and group 5 : hand files and xylol as solvent .
METHODS	The amount of time for gutta-percha removal and the number of fractured instruments were evaluated .
METHODS	Radiographs were taken , and the teeth were grooved longitudinally and split .
METHODS	The area of residual debris was measured using Sigma Scan software .
RESULTS	The time for filling material removal was significantly shorter when GPX was used ( P < .05 ) .
RESULTS	Overall , hand files and solvent produced fewer remnants of filling materials ( P < .05 ) .
RESULTS	In the GPX 25 mm-long teeth group , the filling material was not removed in the apical third .
CONCLUSIONS	Under the experimental conditions , the GPX instruments proved to be faster than hand instruments in removing root filling materials ; however , hand instruments left a smaller amount of residual filling materials on the canal walls .
CONCLUSIONS	The GPX instruments did not pull the gutta-percha beyond its tip .

###10453828
OBJECTIVE	To compare the efficacy of vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term .
METHODS	A single-blind randomised comparative trial .
METHODS	Induction and labour wards of a UK teaching hospital .
METHODS	Two hundred and eleven pregnant women at term in whom induction of labour was indicated , and with no contra-indication to the use of prostaglandins for the induction of labour .
METHODS	The women were randomly assigned to receive vaginal administration of either misoprostol 50 microg four hourly ( to a maximum of four doses ) or dinoprostone gel 1 mg six hourly ( to a maximum of three doses ) .
METHODS	Time from induction to delivery , oxytocin requirement in labour , analgesic requirement , mode of delivery , neonatal outcome .
RESULTS	The misoprostol group had a highly significant reduction in median induction-delivery interval compared with the dinoprostone group ( 14.4 hours vs 22.9 hours ; P < 0.00001 ) .
RESULTS	In addition , more women delivered after only one dose ( 77 % vs 49 % ; P < 0.0001 , OR 3.51 , 95 % CI 1.94-6 .35 ) , and within 12 and 24 hours .
RESULTS	There was a reduced need for oxytocin augmentation in labour ( 21 % vs 47 % ; P < 0.0001 , OR 0.30 , 95 % CI 0.16-0 .54 ) .
RESULTS	There was no difference in analgesia requirement in labour , or in mode of delivery .
RESULTS	There were no adverse neonatal outcomes associated with the use of misoprostol .
RESULTS	Women in the misoprostol group experienced more pain in the interval between induction and being given analgesia in labour , but this did not reach statistical significance .
CONCLUSIONS	Misoprostol 50 microg vaginally is a more effective induction agent than 1 mg dinoprostone vaginal gel , with no apparent adverse effects on mode of delivery , or on the fetus .
CONCLUSIONS	The higher pain scores in the misoprostol group must be balanced against the reduction in time spent having labour induced , and the reduction in need for intravenous oxytocin augmentation .
CONCLUSIONS	Further randomised studies must continue to exclude the possibility of rare adverse side effects .

###22104390
BACKGROUND	Achilles tendinopathy is a common and often debilitating condition , and autologous blood injection is a promising treatment option .
OBJECTIVE	To determine whether autologous blood injection added to standard management was effective in alleviating symptoms of Achilles tendinopathy .
METHODS	A prospective randomized controlled trial .
METHODS	Private sports medicine clinic .
METHODS	33 patients ( 18 women , 15 men ) of mean age 50 y ( SD 9 ) with 40 cases of Achilles tendinopathy of mean duration of 11 mo ( SD 7 ) .
METHODS	Participants were randomized to blind peritendinous autologous blood injection added to standard treatment ( eccentric-loading exercises ) or standard treatment alone for 12 wk .
METHODS	Victorian Institute of Sport Assessment for Achilles ( VISA-A ) score and ratings of discomfort during and after the injection were measured at baseline and 6 and 12 wk .
METHODS	Analytically derived effect-size thresholds of 5 ( small ) and 15 ( moderate ) VISA-A units were used as the reference values for clinical inference .
RESULTS	Improvements in VISA-A of 7.7 units ( 95 % CL : 6.7 ) and 8.7 units ( 8.8 ) were observed in the treatment and control groups , respectively , at 6 wk relative to baseline , with no clear effect of blood injection .
RESULTS	At 12 wk VISA-A score improved to 18.9 units ( 7.4 ) in the treatment group , revealing a blood-injection effect of 9.6 units ( 11.5 ) , relative to a comparatively unchanged condition in control ( 9.4 units ; 9.0 ) .
RESULTS	Predictors of response to treatment were unremarkable , and a 21 % rate of postinjection flare was the only noteworthy side effect .
CONCLUSIONS	There is some evidence for small short-term symptomatic improvements with the addition of autologous blood injection to standard treatment for Achilles tendinopathy , although double-blinded studies with longer follow-up and larger sample size are required .

###16234050
OBJECTIVE	Endoscopic biliary sphincterotomy has complication rates of 5 % -12 % .
OBJECTIVE	The output from the electrosurgical generator may influence the degree of coagulation and the rapidity of the incision , and thus rates of pancreatitis , hemorrhage , and perforation .
OBJECTIVE	Some modern generators incorporate feedback control to standardize output and automate the alternating cut and coagulation modes .
OBJECTIVE	Our aim was to compare 2 feedback-controlled generators , one with constant pure cutting-type output and the other with an alternating cut and coagulation mode .
METHODS	In this multicenter randomized study , 133 patients were assigned to the alternating cut/coag output and 134 patients were assigned to constant pure-cut output .
METHODS	Patients were stratified by their risk for pancreatitis .
RESULTS	The overall pancreatitis rate was 1.5 % , including 3 patients in the cut/coag group and 1 patient in the pure-cut group ( P > .05 ) .
RESULTS	There were 11 poorly controlled ( zipper ) incisions in the pure-cut group and none in the cut/coag group ( P = .02 ) .
RESULTS	The incision was completed in all patients without stalling .
RESULTS	Immediate hemorrhage occurred in 35 pure-cut patients and 8 cut/coag patients output ( P = .002 ) .
RESULTS	There were no episodes of clinically significant bleeding , delayed bleeding , or perforation .
CONCLUSIONS	Biliary sphincterotomy using feedback-controlled generators results in dependable progression of incision with a low pancreatitis rate .
CONCLUSIONS	Control of the incision is improved subjectively with the cut/coagulation output , but this did not translate into a difference in clinically significant complications .

###18557715
OBJECTIVE	Hepatorenal syndrome ( HRS ) is characterized by functional renal failure in end-stage liver disease .
OBJECTIVE	Terlipressin is the drug of choice for treating type 1 HRS ( HRS-1 ) .
OBJECTIVE	It is expensive and often not readily available .
OBJECTIVE	We , in an open label , randomized , pilot trial , compared the efficacy of terlipressin and noradrenaline on the renal functions and clinical outcome of patients with HRS-1 and also sought predictors of response .
OBJECTIVE	PATIENTS AND Forty consecutive patients with HRS-1 were randomized to receive noradrenaline 0.5-3 .0 mg/h and
METHODS	albumin ( group A , N = 20 ) or terlipressin 0.5-2 mg , 6 hourly and albumin ( group B , N = 20 ) , until reversal of HRS ( primary end point ) or completion of 15 days of therapy ( secondary end point ) .
METHODS	Systemic and renal parameters were monitored .
METHODS	Baseline parameters and delta creatinine at day 4 ( DCD4 ) were used to predict response .
RESULTS	The two groups were comparable at baseline .
RESULTS	At similar time points , 10 ( 50 % ) patients in each group achieved primary end points .
RESULTS	Patients in both groups had a significant ( P < 0.05 ) decrease in serum creatinine from baseline ( group A day 4 2.4 + / - 1.2 mg/dL , day 8 1.6 + / - 1.2 mg/dL , and day 15 1.0 + / - 0.4 mg/dL ; group B day 4 2.5 + / - 1.5 mg/dL , day 8 1.8 + / - 0.9 mg/dL , and day 15 1.2 + / - 0.5 mg/dL ) and progressive increase in creatinine clearance ( group A day 4 26.5 + / - 12.8 mL/min and day 15 59.8 + / - 14.2 mL/min ; group B day 4 31.4 + / - 21.4 mL/min and day 15 54.9 + / - 27.5 mL/min , P < 0.05 ) .
RESULTS	Median baseline plasma renin activity was reduced from 38.0 and 42.0 ng/mL/h to 3.0 and 8.0 ng/mL/h ( P = 0.08 ) in groups A and B , respectively .
RESULTS	Mean arterial BP and urine output significantly increased in both groups with therapy .
RESULTS	Eleven ( 55 % ) patients in group A ( 10 responders ) and an equal number in group B ( 8 responders ) survived until day 15 ( P = 0.798 ) .
RESULTS	Reversible cardiac ischemia was seen in one patient in each group .
RESULTS	Noradrenaline therapy was significantly less expensive than terlipressin .
RESULTS	On univariate analysis , the following baseline parameters predicted response to therapy : lower grade of encephalopathy , lower MELD score , higher creatinine clearance , higher mean arterial pressure ( MAP ) , and lower plasma renin activity .
RESULTS	However , on multivariate analysis only baseline creatinine clearance , MAP , and plasma renin activity were independent predictors of response .
RESULTS	At day 4 of therapy , DCD4 was computed and a value of 0.15 mg/dL/day or more accurately predicted response .
RESULTS	The sensitivity , specificity , positive predictive value , and negative predictive value for DCD4 0.15 mg/dL/day for predicting response to therapy were 90 % , 75 % , 78 % , and 88 % , respectively .
CONCLUSIONS	Noradrenaline may be an effective and safe alternative to terlipressin in improving renal functions .
CONCLUSIONS	Various baseline parameters and DCD4 can be used to predict response to therapy .

###20395003
OBJECTIVE	We have different protocols applied in our cardiac center for control of blood glucose ( BG ) , we like to see which protocol can achieve our goal .
METHODS	From a prospective study of 120 diabetic patients randomly assigned to either simple sliding scale or Braithwaite protocol who underwent open heart surgical procedures between 2005 and 2008 .
METHODS	The study group included 80 patients treated with Braithwaite protocol ; the control group included 40 patients treated with simple sliding scale in an attempt to maintain BG level less than 200 mg/dl .
RESULTS	In the study group all the patients were under 200 mg/dl at the end of 48 h postoperatively , which was not achieved in the control group ( P < 0.01 ) .
RESULTS	There was a significant reduction in hospital stay in the study group compared to the control group ( mean in days 9.1 + / -2.3 / 12.3 + / -7.6 ) ( P < 0.001 ) and also there was no wound infection compared to the control group ( 0/5 cases ) .
CONCLUSIONS	The study showed that control of DM in peri-operative period using Braithwaite regimen was of great benefit and safety .

###22260837
OBJECTIVE	This study aimed to compare the 7d triple therapy with 3d and 5d triple therapies , to observe the effect of eradicating Helicobacter pylori ( Hp ) on treating duodenal ulcers .
METHODS	One hundred and sixteen patients who were confirmed duodenal ulcer active period and Hp positive were enrolled in the study .
METHODS	All the patients were divided into three groups : 3d group ( n = 39 ) , 5d group ( n = 37 ) and 7d control group ( n = 40 ) .
METHODS	All three groups were provided triple therapy first : rabeprazole , 10mg + furazolidone , 100mg + clarithromycin 250mg , twice a day for three days , five days and seven days , respectively .
METHODS	Then rabeprazole 10mg was provided once a day .
METHODS	Following the treatment , 13C urea breath test was performed to observe the Hp eradication rate .
METHODS	The symptoms of patients such as epigastralgia , burning pain and acidity were evaluated .
RESULTS	The Hp eradication rate was : 3d group 76 % ( 28/37 ) , 5d 89 % ( 31/35 ) and 7d 91 % ( 32/35 ) .
RESULTS	There was no significant difference between 5d and 7d group ( p > 0.05 ) .
RESULTS	But the rate of groups 5d and 7d was significantly higher than group 3d ( p < 0.05 ) .
RESULTS	All the three groups showed an improvement in symptoms such as epigastralgia , burning pain and acidity .
CONCLUSIONS	All three therapy schemes could alleviate symptoms of duodenal ulcer patients efficiently .
CONCLUSIONS	But as far as eradicating Hp concerned , 5d and 7d therapies were better than 3d .

###17593236
OBJECTIVE	To assess the efficacy and safety of a 24-week treatment with sitagliptin , a highly selective once-daily oral dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , in patients with type 2 diabetes who had inadequate glycaemic control [ glycosylated haemoglobin ( HbA ( 1c ) ) > or = 7.5 % and < or = 10.5 % ] while on glimepiride alone or in combination with metformin .
METHODS	After a screening , diet/exercise run-in and drug wash-off period , a glimepiride + / - metformin dose titration/stabilization period and a 2-week , single-blind placebo run-in , 441 patients ( of ages 18-75 years ) were randomized to receive the addition of sitagliptin 100 mg once daily or placebo in a 1 : 1 ratio for 24 weeks .
METHODS	Of these patients , 212 were on glimepiride ( > or = 4 mg/day ) monotherapy and 229 were on glimepiride ( > or = 4 mg/day ) plus metformin ( > or = 1,500 mg/day ) combination therapy .
METHODS	Patients exceeding pre-specified glycaemic thresholds during the double-blind treatment period were provided open-label rescue therapy ( pioglitazone ) until study end .
METHODS	The primary efficacy analysis evaluated the change in HbA ( 1c ) from baseline to Week 24 .
METHODS	Secondary efficacy endpoints included fasting plasma glucose ( FPG ) , 2-h post-meal glucose and lipid measurements .
RESULTS	Mean baseline HbA ( 1c ) was 8.34 % in the sitagliptin and placebo groups .
RESULTS	After 24 weeks , sitagliptin reduced HbA ( 1c ) by 0.74 % ( p < 0.001 ) relative to placebo .
RESULTS	In the subset of patients on glimepiride plus metformin , sitagliptin reduced HbA ( 1c ) by 0.89 % relative to placebo , compared with a reduction of 0.57 % in the subset of patients on glimepiride alone .
RESULTS	The addition of sitagliptin reduced FPG by 20.1 mg/dl ( p < 0.001 ) and increased homeostasis model assessment-beta , a marker of beta-cell function , by 12 % ( p < 0.05 ) relative to placebo .
RESULTS	In patients who underwent a meal tolerance test ( n = 134 ) , sitagliptin decreased 2-h post-prandial glucose ( PPG ) by 36.1 mg/dl ( p < 0.001 ) relative to placebo .
RESULTS	The addition of sitagliptin was generally well tolerated , although there was a higher incidence of overall ( 60 vs. 47 % ) and drug-related adverse experiences ( AEs ) ( 15 vs. 7 % ) in the sitagliptin group than in the placebo group .
RESULTS	This was largely because of a higher incidence of hypoglycaemia AEs ( 12 vs. 2 % , respectively ) in the sitagliptin group compared with the placebo group .
RESULTS	Body weight modestly increased with sitagliptin relative to placebo ( +0.8 vs. -0.4 kg ; p < 0.001 ) .
CONCLUSIONS	Sitagliptin 100 mg once daily significantly improved glycaemic control and beta-cell function in patients with type 2 diabetes who had inadequate glycaemic control with glimepiride or glimepiride plus metformin therapy .
CONCLUSIONS	The addition of sitagliptin was generally well tolerated , with a modest increase in hypoglycaemia and body weight , consistent with glimepiride therapy and the observed degree of glycaemic improvement .

###12477522
OBJECTIVE	To compare the safety of recombinant human luteinizing hormone ( LH ) with that of urinary hCG in terms of the hemodynamic changes when they are used to induce final follicular maturation in patients undergoing in vitro fertilization ( IVF ) .
OBJECTIVE	A secondary end point was efficacy in terms of IVF outcome .
METHODS	Prospective , randomized clinical trial .
METHODS	University teaching hospital .
METHODS	Thirty IVF patients .
METHODS	Ovarian stimulation was induced with FSH under pituitary suppression .
METHODS	Patients were randomized to receive either hCG or recombinant human LH as a trigger of oocyte maturation ( 5,000 IU ) and for luteal phase support ( 5,000 IU , 2,500 IU , and 2,500 IU on the day of follicular aspiration , 2 days later , and 5 days later , respectively ) .
METHODS	Mean arterial pressure , cardiac output , peripheral vascular resistance , and serum levels of progesterone , plasma concentrations of aldosterone , norepinephrine , and plasma renin activity were measured in all patients on postovulatory day 7 of the spontaneous menstrual cycle preceding IVF ( baseline ) and 7 days after the hCG/recombinant human LH ovulatory injection during the IVF cycle .
RESULTS	Ovarian response and IVF outcome ( pregnancy rate , 60 % ) were similar in both treatment groups .
RESULTS	On the seventh day after hCG/recombinant human LH administration , the peripheral vascular resistance was significantly lower and serum progesterone concentrations significantly higher in the hCG group as compared with the recombinant human LH group .
RESULTS	The percentage change from baseline values during IVF cycles in all hemodynamic and neurohormonal variables investigated was higher ( albeit not statistically different ) in the group treated with hCG vs. the group treated with recombinant human LH .
CONCLUSIONS	Recombinant human LH is associated with less intense circulatory changes than hCG when it is given to induce final follicular maturation and luteal phase support in IVF procedures .

###10533300
BACKGROUND	This study was designed to determine the efficacy and safety of latanoprost 50 micrograms/ml in Chinese patients with primary open-angle glaucoma ( POAG ) and ocular hypertension ( OH ) .
METHODS	A 14-day randomized , double-masked , parallel-group study comparing topical latanoprost with placebo was followed by a 10-week , one-armed , open-labeled latanoprost treatment study .
METHODS	Intraocular pressure ( IOP ) , visual function , ocular manifestations and miscellaneous adverse effects were evaluated at baseline , and days 1 , 7 , 14 , 15 , week 6 and week 12 visits .
RESULTS	Twenty-six eligible patients were enrolled in the study .
RESULTS	The mean IOP was significantly reduced from baseline only in the latanoprost-treated eyes during the first study period ( p = 0.003 on day 1 ; p = 0.004 on day 7 ; p < 0.001 on day 14 ) .
RESULTS	Meanwhile , the mean IOP was significantly lower in the latanoprost-treated eyes than that in the placebo-treated eyes ( p = 0.03 on day 1 ; p = 0.001 on days 7 and 14 ) .
RESULTS	Eyes in both groups showed significantly reduced IOP at each visit of the secondary 10-week latanoprost treatment period , with a mean decrease of 6.12 mmHg .
RESULTS	The IOP-lowering effect showed no diminution throughout the study course .
RESULTS	Conjunctival hyperemia occurred in 16 of all patients who underwent latanoprost treatment and was the most frequent adverse effect observed .
RESULTS	No patient withdrew from the study because of intolerable side-effects .
CONCLUSIONS	Topical latanoprost is effective in reducing IOP for patients with POAG and OH .
CONCLUSIONS	The pressure-lowering effect lasts for at least 24 hours after 1 drop instillation and no drift of effect is noted during this 12-week study .
CONCLUSIONS	Conjunctival hyperemia was the most common side-effect , which was mild in degree and recovered after discontinuation of the medication .

###22032759
OBJECTIVE	To determine whether titrating up and tapering down of desvenlafaxine ( administered as desvenlafaxine succinate ) improves its tolerability in postmenopausal women with vasomotor symptoms ( VMS ) .
METHODS	In the 1-week titration phase , participants received desvenlafaxine 100 mg/d ( no titration ) , desvenlafaxine 50 mg/d , desvenlafaxine 25 mg/d ( 4 days ) then 50 mg/d ( 3 days ) , or desvenlafaxine 25 mg/d .
METHODS	Participants then received open-label desvenlafaxine 100 mg/d for 15 weeks .
METHODS	In the 2-week taper phase , participants received placebo , desvenlafaxine 50 mg/d then placebo ( 7 days each ) , desvenlafaxine 50 mg/d then 25 mg/d ( 7 days each ) , or desvenlafaxine 50 mg/d every other day .
METHODS	Primary endpoints included nausea incidence during the first 2 weeks of treatment and Discontinuation-Emergent Signs and Symptoms ( DESS ) Checklist total scores after taper weeks 1 and 2 .
RESULTS	Nausea incidence was significantly lower for the desvenlafaxine 25 mg/d ( 19 % ) and 50 mg/d ( 22.6 % ) titration regimens vs. no titration ( 35.2 % ; p = 0.004 and p = 0.035 , respectively ) .
RESULTS	At taper week 1 , mean DESS scores were significantly lower for desvenlafaxine 50 mg every other day ( 2.26 , p < 0.001 ) , 50/25 mg/d ( 2.28 , p < 0.001 ) , and 50 mg/d-placebo ( 1.84 , p < 0.001 ) taper regimens vs. no taper ( 7.07 ) .
RESULTS	At week 2 , the mean DESS total score was significantly higher for the desvenlafaxine 50 mg/d-placebo regimen vs. no taper ( 4.46 vs. 2.44 , respectively ; p = 0.009 ) .
RESULTS	Desvenlafaxine 50 mg every other day was the least tolerated of the taper regimens .
CONCLUSIONS	Titration regimens may improve tolerability of desvenlafaxine 100 mg/d in postmenopausal women with VMS .
CONCLUSIONS	Taper regimens of desvenlafaxine 50 mg/d-placebo or 50/25-mg/d , were better tolerated than abrupt discontinuation or desvenlafaxine 50 mg given every other day taper regimen .

###16282244
BACKGROUND	Recombinant human angiostatin ( rhAngiostatin ) functions as a potent inhibitor of angiogenesis .
BACKGROUND	This study combined rhAngiostatin with a standard chemotherapy regimen in patients with advanced non-small-cell lung cancer ( NSCLC ) .
METHODS	Eligible patients had chemotherapy-nave stage IIIB ( with pleural effusion ) or IV NSCLC , performance status ( PS ) 0 or 1 , no history of bleeding , brain metastasis or requirements for anti-coagulation .
METHODS	Patients received carboplatin ( AUC 5 ) intravenously and paclitaxel ( 175 mg/m2 ) intravenously day 1 + subcutaneous rhAngiostatin at either 15 mg or 60 mg twice daily .
METHODS	Cycles were repeated every 3 weeks , for up to six cycles .
METHODS	Patients without progression after completing at least four cycles were continued on maintenance rhAngiostatin until disease progression .
RESULTS	Patient characteristics ( n = 24 ) were : 16 males , median age 66 years ( range 45-78 ) , 54 % PS 1 , 83.3 % stage IV and 62.5 % adenocarcinoma .
RESULTS	Grade 3/4 toxicities included : fatigue 47.8 % , neutropenia 39.1 % , dyspnea 39.1 % , vascular 26.1 % and infection 17.4 % .
RESULTS	The overall response rate was 39.1 % , 39.1 % stable disease and 21.7 % progressive disease .
RESULTS	Median time to progression was 144 days , and 1-year survival was 45.8 % .
CONCLUSIONS	rhAngiostatin in combination with paclitaxel and carboplatin is feasible and results in a high disease control rate in patients with advanced NSCLC .

###22958307
BACKGROUND	Cat fleas , Ctenocephalides felis , are one of the most common ectoparasites infesting dogs and their environments .
BACKGROUND	This study evaluated the efficacy of imidacloprid + pyriproxyfen ( PPF ) ( Advantage II for Dogs ) and spinosad ( Comfortis ) against established C. felis populations in dogs ' simulated home environments .
METHODS	Thirty Beagle dogs were randomly assigned to three groups of 10 dogs each and treated twice ( Study Days 0 and 28 ) with imidacloprid + PPF , spinosad tablets , or a negative control ( untreated ) .
METHODS	Dogs were housed individually in controlled simulated home environments capable of supporting the flea life cycle .
METHODS	Flea infestations were established in these environments by infesting each dog with 100 adult cat fleas on Study Days -21 , -16 and 1 .
METHODS	The impact of the treatments on fleas in the dogs ' environments were assessed by collecting floor mat samples from each simulated home environment , incubating them for 32 days , and counting the number of emerging adult fleas .
METHODS	On Study Days 7 , 14 , 21 , 28 , 35 , 42 , 49 and 56 , after collection of the cocoa matting samples , each dog was infested with an additional 51 fleas to maintain the environmental infestations .
METHODS	Flea comb counts on dogs were conducted on Study Days 0 ( pretreatment ) and 63 .
RESULTS	From Study Days 7-28 , flea infestations in the imidacloprid + PPF environments were significantly lower ( p < 0.03 ) than those in the spinosad environments .
RESULTS	Following the second treatment , flea infestations in all the imidacloprid + PPF environments fell to zero for the remainder of the study .
RESULTS	In contrast , flea infestations persisted in some of the spinosad environments through the study 's end.On Study Day 63 all 10 dogs treated with imidacloprid + PPF were flea free , while only one of the 10 spinosad treated dogs was flea free .
RESULTS	Flea counts on the other 9 spinosad treated dogs ranged from 3 to 46 fleas/dog ( geometric mean = 8.6 ) .
RESULTS	A mean of 405 adult fleas/animal were recovered from the control dogs on Study Day 63 .
CONCLUSIONS	Flea infestations in environments of dogs treated with imidacloprid + PPF declined more rapidly than in those containing dogs treated with spinosad .
CONCLUSIONS	Flea infestations were completely eliminated by Study Day 56 in environments of dogs treated with imidacloprid + PPF , but persisted through the study 's end in some of environments of dogs treated with spinosad .

###24946630
OBJECTIVE	To observe the difference in clinical efficacy on focal vitiligo treated with heat-sensitive moxibustion in comparison with medication , and discuss its effect mechanism .
METHODS	Sixty-eight cases were randomized into a moxibustion group ( 38 cases ) and a medication group ( 30 cases ) .
METHODS	Additionally , 20 healthy persons were selected randomly as a normal group .
METHODS	In the moxibustion group , the heat-sensitive moxibustion was applied to Hegu ( LI 4 ) , Quchi ( LI 11 ) , Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Xuehai ( SP 10 ) and the others , once a day .
METHODS	In the medication group , triamcinolone acetonide cream was used externally and locally , twice a day .
METHODS	In the two groups , the treatment of 15 days made one session .
METHODS	The efficacy was observed after continuous treatment for 3 sessions .
METHODS	The hemorheology test was done in all of the subjects .
METHODS	The radioimmunoassay was adopted to determine the levels of Interleukin 2 ( IL-2 ) , Interleukin 6 ( IL-6 ) , Interleukin 10 ( IL-10 ) and tumor necrosis factor ( TNF-alpha ) before and after treatment .
RESULTS	The levels of IL-6 , IL-10 and TNF-alpha in vitiligo patients were higher significantly than those in the normal group ( P < 0.01 , P < 0.05 ) , the level of IL-2 was lower significantly than that in the normal group ( P < 0.01 ) before treatment .
RESULTS	After 3 sessions treatment , IL-2 level was increased significantly in the moxibustion group and the levels of IL-6 , IL-10 and TNF-alpha were reduced , without significant differences as compared with the normal group ( all P > 0.05 ) .
RESULTS	But the differences were significant as compared with those in the medication group ( all P < 0.05 ) .
RESULTS	The curative and remarkably effective rate was 76.3 % ( 29/38 ) after treatment in the moxibustion group , which was higher significantly than 13.3 % ( 4/30 , P < 0.05 ) in the medication group .
CONCLUSIONS	Heat-sensitive moxibustion achieves very good clinical efficacy on focal vitiligo , which is probably via promoting blood circulation and regulating the levels of IL-6 , IL-10 and TNF-alpha .

###25139116
OBJECTIVE	To explore whether subjects harbouring A. actinomycetemcomitans , P. gingivalis or T. forsythia at baseline showed increased clinical benefits with the adjunctive use of systemic amoxicillin and metronidazole ( AMX-MET ) during non-surgical treatment of generalized aggressive periodontitis ( GAgP ) .
METHODS	Forty one subjects were included in this 6-month randomized placebo-controlled clinical trial using a 7-day course of systemic AMX-MET or placebo as adjuncts to non-surgical periodontal therapy .
METHODS	Clinical and microbiological parameters were collected at baseline , 2 and 6months after treatment .
METHODS	Microbiological cultures were processed for pooled subgingival samples and identities of isolates were determined by PCR for A. actinomycetemcomitans , P. gingivalis and T. forsythia
RESULTS	At 6months , the test treatment resulted in significant additional improvements in the primary outcome variable compared to placebo , and the effect of the adjunctive antimicrobials was not modified by the baseline microbiological status in the primary analysis .
RESULTS	However , secondary exploratory subgroup analyses showed improved clinical outcomes in subjects harbouring A. actinomycetemcomitans at baseline compared to subjects who did not harbour this pathogen .
CONCLUSIONS	All subjects benefited from the tested adjunctive antimicrobial regimen , although subjects who harboured A. actinomycetemcomitans at baseline may show greater clinical benefits .
CONCLUSIONS	Larger appropriately powered studies are needed to confirm whether adjunctive AMX-MET is more beneficial for GAgP patients who harbour A. actinomycetemcomitans , along with other key periodontal pathogens .

###12519109
BACKGROUND	The purpose of this study was to compare peri-operative morbidity , preoperative sonographic estimation of uterine weight and postoperative outcomes of women with uterine fibroids larger than 6 cm in diameter or uteri estimated to weigh at least 450 g , undergoing either vaginal , laparoscopically assisted vaginal or abdominal hysterectomies .
METHODS	Ninety patients who met the criteria of uterine fibroids larger than 6 cm by ultrasonographic examination were included in our prospective study .
METHODS	Patients were randomized into laparoscopic-assisted vaginal hysterectomy ( 30 patients ) , vaginal hysterectomy ( 30 patients ) and abdominal hysterectomy ( 30 patients ) groups .
RESULTS	The laparoscopically assisted vaginal hysterectomy group had significantly longer operative times than the abdominal and vaginal hysterectomy groups ( 109 + / - 22 min , 98 + / - 16 min , and 74 + / - 22 min , respectively , p < 0.001 ) .
RESULTS	Blood loss for vaginal hysterectomy was significantly lower than for either abdominal or laparoscopically assisted vaginal hysterectomies ( 215 + / - 134 ml , 293 + / - 182 ml , and 343 + / - 218 ml , respectively , p = 0.04 ) .
RESULTS	Vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy groups had shorter hospital stays , lower postoperative pain scores , more rapid bowel recovery and lower postoperative antibiotic use than the abdominal hysterectomy group .
RESULTS	Uterine weight in the abdominal hysterectomy group was significantly heavier than in the vaginal and laparoscopically assisted vaginal hysterectomy groups ( 1020 + / - 383 g , 835 + / - 330 g , and 748 + / - 255 g , respectively , p = 0.02 ) .
RESULTS	We estimated that when a myoma measured between 8 and 10 cm , the uterus weighed approximately 450 g , and the sensitivity of this prediction was 57.5 % .
RESULTS	For a myoma larger than 13 cm , the estimated uterine weight was more than 900 g and the sensitivity of this prediction was 71 % .
CONCLUSIONS	The study shows vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy can be performed in women with uterine weight of at least 450 g. Preoperative ultrasonographic examination can provide the surgeon with valuable information on the size of the fibroid and the estimated weight of the enlarged uterus before implementing a suitable surgical method .

###8853250
OBJECTIVE	To investigate the influence of untreated ( super ) morbid obesity and the effects of massive weight loss and chronic gastric distension on gastro-oesophageal reflux .
METHODS	Seventeen young morbidly obese patients ( 32 years old ; body weight 166.5 kg ; body mass index 55 kg/m2 ) underwent 24-h ambulatory oesophageal pH monitoring before weight reduction and 4 months after treatment with energy-restricted diet , physical exercise and intragastric balloon or sham placement in a randomized , double-blind design .
METHODS	To minimize bias , both 24-h pH measurements were performed under similar conditions and dietary intake , and patients were matched for age , sex , body weight and body mass index .
RESULTS	At the start , group median data for the fraction of total time , time upright and time supine with pH less than 4 were within normal limits .
RESULTS	After a major median weight loss of 38.8 kg in 4 months these parameters did not change .
RESULTS	On an individual basis , five out of 17 patients had pathological acid reflux prior to weight loss .
RESULTS	This reversed to normal in three subjects , but remained abnormal in two and became abnormal in one patient .
RESULTS	The weight loss ( 58.4 kg ) of those remaining or becoming acid refluxers was significantly different ( P < 0.01 ) from those with normal or normalizing pH measurements ( 36.9 kg ) .
RESULTS	A 4-month period of gastric distension by a 500 ml balloon did not influence acid reflux parameters .
CONCLUSIONS	The influence of untreated ( super ) morbid obesity on acid reflux was less pronounced than expected .
CONCLUSIONS	There was also no major adverse effect of chronic gastric distension .
CONCLUSIONS	Only excessive weight loss ( i.e. 58 kg ) appeared to have an untoward effect on acid reflux .

###16110025
OBJECTIVE	The purpose of this study was to define the contribution of docetaxel to combination chemotherapy in the outcome of patients with advanced gastric or gastroesophageal adenocarcinoma .
OBJECTIVE	We compared the overall response rate ( ORR ) and safety of docetaxel plus cisplatin ( DC ) with DC plus fluorouracil ( DCF ) to select either DC or DCF as the experimental treatment in the ensuing phase III part of trial V-325 .
METHODS	In this phase II randomized study , untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received either DCF ( docetaxel 75 mg/m2 , cisplatin 75 mg/m2 on day 1 , and fluorouracil 750 mg/m2/d as continuous infusion on days 1 to 5 ) or DC ( docetaxel 85 mg/m2 and cisplatin 75 mg/m2 on day 1 ) every 3 weeks .
METHODS	An independent data monitoring committee ( IDMC ) was to select one of the two regimens based primarily on ORR and safety profile .
RESULTS	Of 158 randomly assigned patients , 155 ( DCF , n = 79 ; DC , n = 76 ) received treatment .
RESULTS	The confirmed ORR was 43 % for DCF ( n = 79 ) and 26 % for DC ( n = 76 ) .
RESULTS	Median time to progression was 5.9 months for DCF and 5.0 months for DC .
RESULTS	Median overall survival time was 9.6 months for DCF and 10.5 months for DC .
RESULTS	The most frequent grade 3 and 4 events per patient included neutropenia ( DCF = 86 % ; DC = 87 % ) and GI ( DCF = 56 % ; DC = 30 % ) .
CONCLUSIONS	Both regimens were active , but DCF produced a higher confirmed ORR than DC .
CONCLUSIONS	Toxicity profiles of DCF were considered manageable .
CONCLUSIONS	The IDMC chose DCF for the phase III part of V-325 , which compares DCF with cisplatin plus fluorouracil .

###18764698
OBJECTIVE	To determine effects of vaccination with siderophore receptor and porin ( SRP ) proteins derived from Salmonella enterica serotype Newport on milk production , somatic cell count , and shedding of Salmonella organisms in female dairy cattle .
METHODS	180 female Holsteins .
METHODS	Cattle were randomly assigned to receive Salmonella Newport SRP vaccine or control solution .
METHODS	Vaccine or control solution was injected 45 to 60 days before parturition , and cattle received a second dose 14 to 21 days before parturition .
METHODS	Milk production was monitored for the first 90 days of lactation .
METHODS	Feces for isolation of Salmonella and blood samples for detection of antibodies against Salmonella Newport were collected at day of first injection and at days 7 to 14 and 28 to 35 of lactation .
RESULTS	Cattle inoculated with Salmonella Newport vaccine produced significantly more milk ( 1.14 kg/d ) , compared with cattle injected with the control solution .
RESULTS	Cattle administered the vaccine had significantly higher concentrations of circulating antibody against Salmonella Newport SRP proteins at 7 to 14 days and 28 to 35 days of lactation .
RESULTS	Salmonella Newport was not recovered ; however , Salmonella enterica serotype Agona was recovered from 31 ( 20.3 % ) cattle , but likelihood of recovery did not differ significantly between vaccinates and control cattle .
CONCLUSIONS	Administration of a vaccine against Salmonella Newport SRP proteins to healthy dairy cattle prior to parturition increased milk production , even in cattle without detectable shedding of Salmonella Newport or clinical signs of salmonellosis .
CONCLUSIONS	Additional research is needed to clarify the mechanisms by which productivity was improved .

###12144586
BACKGROUND	Laxatives are frequently ineffective in treating constipation .
BACKGROUND	An alternative therapeutic approach is to target serotonin-4 receptors , which are involved in initiating peristalsis .
OBJECTIVE	In a double-blind , placebo-controlled trial , to assess the efficacy and safety of a systemically active serotonin-4 agonist , prucalopride .
METHODS	Seventy-four women with constipation were stratified into slow or normal transit groups , and each group was randomized to receive either placebo or 1 mg prucalopride daily for 4 weeks .
METHODS	A bowel function diary was maintained .
METHODS	Whole-gut and orocaecal transit , visceral sensitivity , quality of life and psychological state were assessed before and after treatment .
RESULTS	Prucalopride , not placebo , increased spontaneous stool frequency ( P = 0.008 ) and reduced time to first stool ( P < 0.001 ) .
RESULTS	Prucalopride reduced the number of retained markers in all patients compared to placebo ( P = 0.004 ) .
RESULTS	Prucalopride reduced the mean number of retained markers in slow transit ( P = 0.069 ) , but did not alter the marker count in normal transit ( P = 0.86 ) .
RESULTS	Orocaecal transit was accelerated by prucalopride , not placebo ( P = 0.004 ) .
RESULTS	Prucalopride , notplacebo , increased rectal sensitivity to distension ( urge volume , P = 0.01 ) and electrical stimulation ( P = 0.001 ) .
RESULTS	Prucalopride significantly improved several domains of the Short Form Health Status Survey and the disease-specific quality of life .
RESULTS	Adverse effects were similar for prucalopride and placebo .
CONCLUSIONS	Prucalopride improves symptoms , upper gut transit and gut sensitivity in constipated patients with both slow and normal transit .
CONCLUSIONS	It improves transit in patients with slow transit .
CONCLUSIONS	These changes are associated with improved well-being .

###10065804
OBJECTIVE	To evaluate the safety and effectiveness of a new closed parallel technique of Veress needle insertion and to compare this method with the conventional closed approach .
METHODS	Sequential , randomized , prospective , single-blind clinical trial .
METHODS	University hospital .
METHODS	Women undergoing elective diagnostic and/or operative laparoscopy .
METHODS	Subjects ( n = 200 ) were assigned randomly to undergo the conventional closed method ( group 1 ; n = 100 ) or the new parallel technique ( group 2 ; n = 100 ) of Veress needle insertion .
METHODS	Randomization of the patients was performed in the operating room .
METHODS	The investigator performed both diagnostic and operative laparoscopy in both study groups .
METHODS	Safety and effectiveness of the needle insertion technique .
RESULTS	There were no significant differences in demographics between the groups , or in the time required for Veress needle insertion to establish pneumoperitoneum .
RESULTS	There were no nonlethal major or minor intraoperative complications associated with either laparoscopic approach .
CONCLUSIONS	There is no significant disadvantage to the parallel technique of Veress pneumoperitoneum needle insertion compared with the conventional closed approach .
CONCLUSIONS	This new technique avoids the anatomic location of large vessels during insertion and may serve as a safeguard to decrease the potential for lethal laceration of a major vessel .

###16649836
OBJECTIVE	To conduct the first randomized , controlled trial assessing the prophylactic efficacy of gabapentin in bipolar disorder .
METHODS	We conducted a 1-year , double-blind , randomized , comparative , placebo-controlled , parallel-group , multicenter study .
METHODS	As this was a pure prophylactic trial , only euthymic bipolar I and II patients ( DSM-IV ) were randomly assigned in a 1:1 ratio to gabapentin ( N = 13 ) or placebo ( N = 12 ) added to the current treatment ( lithium , valproate , carbamazepine , or any combination but not antipsychotics or antidepressants ) .
METHODS	Subjects participated in the study for 12 months .
METHODS	The primary efficacy parameter was the Clinical Global Impressions scale for Bipolar Illness , Modified ( CGI-BP-M ) , which was assessed at all visits .
METHODS	Other assessments were the Young Mania Rating Scale ( YMRS ) , Hamilton Rating Scale for Depression ( HAM-D ) , Hamilton Rating Scale for Anxiety ( HAM-A ) , Pittsburgh Sleep Quality Index ( PSQI ) , and the systematic collection of reported adverse events .
METHODS	Data were collected from May 1999 to February 2004 .
RESULTS	The change from baseline to month 12 in mean CGI-BP-M scores between groups was statistically significant ( p = .0046 ) .
RESULTS	Mean score change from baseline to endpoint in the gabapentin group was -2.1 , and the mean score change in the placebo group was -0.6 .
RESULTS	No emerging manic or depressive symptoms were seen in either group as measured with the YMRS , HAM-D , HAM-A , and PSQI .
RESULTS	In the PSQI-6 subscale ( use of sleeping medication ) , the mean score change at month 12 in the gabapentin group was 0.9 , and the mean score change in the placebo group was 0.05 ( p = .0267 ) .
RESULTS	Overall , gabapentin was well tolerated .
CONCLUSIONS	This small , randomized clinical trial comparing the prophylactic efficacy of adjunctive gabapentin to placebo suggests that , despite lack of acute efficacy , treatment with gabapentin might provide some benefit on the long-term outcome of bipolar disorder .

###25450131
OBJECTIVE	To compare maximal evoked torque , discomfort , and fatigue-related outcomes between multipath neuromuscular electrical stimulation ( NMES ) and conventional NMES of the quadriceps muscle in patients with total knee arthroplasty ( TKA ) .
METHODS	Randomized , single-blind , crossover study with 2 experimental sessions ( multipath NMES , conventional NMES ) .
METHODS	Research laboratory .
METHODS	Patients ( N = 20 ; mean age , 68y ) 6 to 12 months after TKA surgery .
METHODS	None .
METHODS	We quantified NMES-evoked knee extension torque at the maximally tolerated current intensity , self-reported discomfort , and fatigue induced by NMES intermittent contractions in both conditions .
RESULTS	Compared with conventional NMES , multipath NMES resulted in higher evoked torque ( 33 % , P < .001 ) , lower discomfort scores ( -39 % , P < .001 ) , and less quadriceps muscle fatigue ( P = .034 ) .
CONCLUSIONS	The use of multiple current pathways distributed to large electrodes allowed multipath NMES to generate stronger contractions and reduce discomfort and fatigue compared with conventional NMES .
CONCLUSIONS	Therefore , multipath NMES has the potential to be more effective than conventional NMES .

###8407399
OBJECTIVE	A prospective randomized trial evaluating adjuvant brachytherapy for soft tissue sarcomas was conducted between July 1982 and July 1987 .
METHODS	One hundred twenty-six patients with soft tissue sarcoma of the extremity or superficial trunk ( STS ) underwent grossly complete resection with limb-sparing surgery .
METHODS	Intra-operatively , patients were randomized to receive either adjuvant brachytherapy ( BRT ) or no further therapy ( no BRT ) .
METHODS	BRT consisted of an Iridium-192 implant which delivered 4200-4500 cGy over 4-6 days .
METHODS	Total hospital stay for combined surgery and BRT was 10-14 days .
METHODS	Patients in each group were well matched with respect to age , sex , site , tumor size , depth , histologic type , and grade .
METHODS	Median follow-up is 66.5 months for all living patients .
RESULTS	At 5 years , local control was 82 % in the BRT group vs. 67 % in the no BRT group ( p = .049 ) .
RESULTS	When analyzed by histologic grade , high grade tumors had local control of 90 % with BRT vs. 65 % with no BRT ( p = .013 ) .
RESULTS	There was no difference in local control in the low grade patients in either arm .
RESULTS	At 5 years , the proportion free of distant metastases was approximately 76 % in both arms , with no difference between BRT and no BRT .
RESULTS	When analyzed by grade , high grade patients had a similar proportion free of distant metastasis in the BRT vs. no BRT arms despite improved local control in those receiving BRT .
RESULTS	Similarly , the disease-specific survival for all patients at 5 years was 81 % for BRT vs. 80 % for no BRT ( p = NS ) .
RESULTS	When analyzed by grade , and treatment ( BRT vs. no BRT ) , 5-year disease-specific survival for high grade was the same in both groups .
CONCLUSIONS	Adjuvant BRT significantly improves local control in completely resected STS .
CONCLUSIONS	This improvement is confined to patients with high grade histology .
CONCLUSIONS	BRT provides excellent local control in this group , and significantly shortens the treatment time when compared to adjuvant external beam radiation .
CONCLUSIONS	However , the improved local control does not translate into either decreased distant metastasis or increased disease-specific survival .

###16389216
BACKGROUND	Despite the persistence of attention-deficit/hyperactivity disorder ( ADHD ) into adolescence , little is known about the efficacy and tolerability of stimulant medications in this age group .
OBJECTIVE	To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system ( OROS ) methylphenidate .
METHODS	Adolescents ( N = 220 ) having a confirmed Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria .
METHODS	Subjects successfully completing the dose titration phase ( n = 177 ) ( ie , tolerated and responded to treatment and adhered to the protocol ) were randomized to receive 2 weeks ' treatment with their individualized dosage of OROS methylphenidate ( 18 , 36 , 54 , or 72 mg once daily ) or placebo .
METHODS	Treatment effectiveness was measured using investigator , parent , and adolescent assessments of ADHD .
RESULTS	A significant reduction from baseline in the investigator-rated ADHD Rating Scale , the primary efficacy measure , was found with OROS methylphenidate treatment compared with placebo .
RESULTS	Similar findings were noted with parent - and adolescent-report measures .
RESULTS	Based on a Clinical Global Impression improvement subscale score of much or very much improved , 52 % of subjects in the OROS methylphenidate group improved compared with 31 % receiving placebo .
RESULTS	Thirty-seven percent of subjects required the maximum dosage of 72 mg/d .
RESULTS	The incidence of drug-related adverse events was similar between the 2 study groups .
CONCLUSIONS	In adolescents , once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d .

###14551301
OBJECTIVE	We evaluated the feasibility , safety , and immunogenicity of mature , peptide-pulsed dendritic cell ( DC ) vaccines administered by different routes .
METHODS	We performed a randomized , phase I , dose-escalation study in 27 patients with metastatic melanoma receiving four autologous peptide-pulsed DC vaccinations .
METHODS	Patients were randomly assigned to an intravenous ( IV ) , intranodal ( IN ) , or intradermal ( ID ) route of administration ( ROA ) .
METHODS	For each route , primary end points were dose-limiting toxicity , maximum-tolerated dose , and T-cell sensitization .
METHODS	Sensitization was evaluated through tetramer staining , in vitro peptide recognition assays , and delayed-type hypersensitivity ( DTH ) responses .
RESULTS	Twenty-two ( 81.5 % ) of 27 patients completed all four vaccinations .
RESULTS	Vaccinations were well tolerated ; a few patients exhibited grade 1 to 2 toxicities including rash , fever , and injection site reaction .
RESULTS	All routes of administration induced comparable increases in tetramer-staining CD8 + T cells ( five of seven IV , four of seven IN , and four of six ID patients ) .
RESULTS	However , the IN route induced significantly higher rates for de novo development of CD8 + T cells that respond by cytokine secretion to peptide-pulsed targets ( six [ 85.7 % ] of seven IN patients v two [ 33 % ] of six ID patients v none [ 0 % ] of six IV patients ; P = .005 ) and de novo DTH ( seven [ 87.5 % ] of eight IN patients v two [ 33.3 % ] of six ID patients v one [ 14.3 % ] of seven IV patients ; P = .01 ) compared with other routes .
CONCLUSIONS	Administration of this peptide-pulsed mature DC vaccine by IN , IV , or ID routes is feasible and safe .
CONCLUSIONS	IN administration seems to result in superior T-cell sensitization as measured by de novo target-cell recognition and DTH priming , indicating that IN may be the preferred ROA for mature DC vaccines .

###17904989
OBJECTIVE	The purpose of this study was to estimate the effect of sonographic cervical length ( CL ) and fetal fibronectin ( FFN ) on length of evaluation and outcomes in women with preterm labor ( PTL ) .
METHODS	Women with threatened PTL were randomized to either a knowledge group ( results of CL and FFN available and used according to study protocol ) , or a standard group ( blinded to CL and FFN ) .
METHODS	Primary outcome was length of evaluation in triage .
RESULTS	One hundred women were randomized .
RESULTS	There was no significant difference between groups in length of evaluation , but in women with CL > or = 30 mm , the mean time for evaluation was significantly shorter in the knowledge group ( 1:58 h + / - 0:50 vs 2:53 h + / - 0:50 , P = .004 ) .
RESULTS	Incidence of spontaneous preterm birth ( SPTB ) in the knowledge group was significantly reduced ( 13.0 vs 36.2 % , P = .01 ) .
CONCLUSIONS	The knowledge of CL and FFN was associated with reduction in length of evaluation in women with CL > or = 30 mm and in incidence of SPTB in all women with PTL .

###24814583
BACKGROUND	Infectious complications and especially anastomotic leakage ( AL ) severely impede the recuperation of patients following colorectal cancer ( CRC ) surgery .
BACKGROUND	When the normal gut barrier fails , as in AL , pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality .
BACKGROUND	Moreover , AL has a negative impact on the CRC prognosis .
BACKGROUND	Selective decontamination of the digestive tract ( SDD ) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection .
METHODS	In this multicentre randomised clinical trial , perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent .
METHODS	The SDD regimen consists of colistin , tobramycin and amphotericin B.
METHODS	The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications .
METHODS	A main secondary objective is improvement of the cancer-free survival .
METHODS	A total of 762 patients will be included in total for sufficient power .
CONCLUSIONS	It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients .
BACKGROUND	The trial is investigator-initiated , investigator-driven and supported by the Dutch Digestive Foundation ( WO 11-06 ) and the private Posthumus Meyes Fund .
BACKGROUND	The trial is registered at ClinicalTrials.gov : NCT01740947 .

###11180018
BACKGROUND	Rifampin ( rifampicin ) is a potent inducer of several cytochrome P450 ( CYP ) enzymes , including CYP3A4 .
BACKGROUND	The cholesterol-lowering drug simvastatin has an extensive first-pass metabolism , and it is partially metabolized by CYP3A4 .
BACKGROUND	This study was conducted to investigate the effect of rifampin on the pharmacokinetics of simvastatin .
METHODS	In a randomized cross-over study with two phases and a washout of 4 weeks , 10 healthy volunteers received a 5-day pretreatment with rifampin ( 600 mg daily ) or placebo .
METHODS	On day 6 , a single 40-mg dose of simvastatin was administered orally .
METHODS	Plasma concentrations of simvastatin and its active metabolite simvastatin acid were measured up to 12 hours with a sensitive liquid chromatography-ion spray tandem mass spectrometry method .
RESULTS	Rifampin decreased the total area under the plasma concentration-time curve of simvastatin and simvastatin acid by 87 % ( P < .001 ) and 93 % ( P < .001 ) , respectively .
RESULTS	Also the peak concentrations of both simvastatin and simvastatin acid were reduced greatly ( by 90 % ) by rifampin ( P < .001 ) .
RESULTS	On the other hand , rifampin had no significant effect on the elimination half-life of simvastatin or simvastatin acid .
CONCLUSIONS	Rifampin greatly decreases the plasma concentrations of simvastatin and simvastatin acid .
CONCLUSIONS	Because the elimination half-life of simvastatin was not affected by rifampin , induction of the CYP3A4-mediated first-pass metabolism of simvastatin in the intestine and the liver probably explains this interaction .
CONCLUSIONS	Concomitant use of potent inducers of CYP3A4 can lead to a considerably reduced cholesterol-lowering efficacy of simvastatin .

###16669719
BACKGROUND	The main objective was to assess the efficacy of a weight management program designed for outpatients taking olanzapine for schizophrenia or schizoaffective disorder and to compare these patients with a randomized control group .
BACKGROUND	The effects of the weight management program were also assessed with regard to safety and quality of life .
METHODS	Forty-eight patients were enrolled in a 12-week , randomized , multicenter weight management study .
METHODS	Thirty-three patients were randomly allocated to an intervention group in which they received olanzapine within a weight management program .
METHODS	Fifteen patients were allocated to a control group in which they were given olanzapine treatment as usual outpatients .
METHODS	Weight , body mass index ( BMI ) , and measurements of safety and quality of life were evaluated .
METHODS	The study was conducted from January 7 , 2003 , to September 16 , 2003 .
RESULTS	Thirty-six patients ( 75 % ) completed this study .
RESULTS	We found significant differences in weight ( -3.94 + / - 3.63 kg vs. -1.48 + / - 1.88 kg , p = .006 ) and BMI ( -1.50 + / - 1.34 vs. -0.59 + / - 0.73 , p = .007 ) change from baseline to endpoint between the intervention and control groups , respectively .
RESULTS	Significant differences in weight reduction were initially observed at week 8 ( p = .040 ) .
RESULTS	No significant differences were found with regard to the safety outcomes .
RESULTS	When the ratio of low-density lipoproteins to high-density lipoproteins was calculated , change from baseline was greater in the intervention group than the control group ( -0.19 vs. -0.04 ) , but the difference was not statistically significant ( p = .556 ) .
RESULTS	After the completion of the weight management program , there was a trend toward statistical difference in the physical health score changes between the weight management and control groups ( 1.12 in the intervention group vs. -0.93 in the control group , p = .067 ) .
CONCLUSIONS	The weight management program was effective in terms of weight reduction in patients with schizophrenia or schizoaffective disorder taking olanzapine and was also found to be safe in terms of psychiatric symptoms , vital signs , and laboratory data .
CONCLUSIONS	In addition , such a weight management program might improve quality of life in patients with schizophrenia or schizoaffective disorder with respect to their physical well-being .

###19309327
BACKGROUND	We examined the effects of a foster care intervention on attention and emotion expression in socially deprived children in Romanian institutions .
METHODS	Institutionalized children were randomized to enter foster care or to remain under institutional care .
METHODS	Subsequently , the institutionalized and foster care groups , along with a community-based comparison group , were evaluated on emotion tasks at 30 and 42 months of age .
METHODS	Behaviors reflecting positive and negative affect and attention were coded from videotapes .
RESULTS	Data indicated that at both age points , children who received the foster care intervention showed higher levels of attention and positive affect compared to children who remained institutionalized .
RESULTS	Compared to the community sample , children in the foster care intervention showed higher levels of attention to the emotion-eliciting tasks at 42 months of age .
CONCLUSIONS	The results of this randomized trial demonstrate the impact of a family-based intervention on the development of attention and positive affect .

###20460257
BACKGROUND	Methacholine hyperresponsiveness is prevalent in elite athletes .
BACKGROUND	Comparative studies have hitherto been limited to methacholine , eucapnic voluntary hyperpnoea and exercise .
BACKGROUND	This study investigated airway responsiveness to these stimuli as well as to adenosine 5 ' - monophosphate ( AMP ) and mannitol , in 58 cross-country ski athletes .
METHODS	Exhaled nitric oxide concentration ( F ( E ) NO ) , spirometry and bronchial challenge in random order with methacholine , AMP and mannitol were consecutively performed on three study days in the autumn .
METHODS	Specific IgE to eight aeroallergens and a self-completed questionnaire about respiratory symptoms , allergy and asthmatic medication were also performed on day 1 .
METHODS	Eucapnic voluntary hyperventilation ( EVH ) and field exercise tests were randomly performed in 33 of the skiers on two study days in the following winter .
RESULTS	Of 25 ( 43 % ) skiers with airway hyperresponsiveness ( AHR ) , 23 , five and three skiers were hyperresponsive to methacholine , AMP and mannitol , respectively .
RESULTS	Methacholine hyperresponsiveness was more prevalent in subjects without asthma-like symptoms .
RESULTS	The F ( E ) NO was not significantly different in skiers with and without methacholine hyperresponsiveness .
RESULTS	Four of 14 skiers with and four of 19 skiers without methacholine hyperresponsiveness were hyperresponsive to EVH or exercise challenge .
RESULTS	AHR to any stimulus was present in 16 asymptomatic and nine symptomatic skiers .
RESULTS	Asthma-like symptoms were not correlated with AHR to any stimulus .
CONCLUSIONS	Methacholine hyperresponsiveness is more common in asymptomatic skiers and is a poor predictor of hyperresponsiveness to mannitol and hyperpnoea .
CONCLUSIONS	The low prevalence of hyperresponsiveness to indirect stimuli may suggest differences in the pathogenesis of methacholine hyperresponsiveness in elite skiers and non-athletes .

###20163990
BACKGROUND	Daclizumab , a humanised monoclonal antibody , reduced multiple sclerosis disease activity in previous non-randomised studies .
BACKGROUND	We aimed to assess whether daclizumab reduces disease activity in patients with active relapsing multiple sclerosis who are receiving interferon beta treatment .
METHODS	We did a phase 2 , randomised , double-blind , placebo-controlled study at 51 centres in the USA , Canada , Germany , Italy , and Spain .
METHODS	Patients with active relapsing multiple sclerosis who were taking interferon beta were randomly assigned to receive add-on subcutaneous daclizumab 2 mg/kg every 2 weeks ( interferon beta and high-dose daclizumab group ) , daclizumab 1 mg/kg every 4 weeks ( interferon beta and low-dose daclizumab group ) , or interferon beta and placebo for 24 weeks .
METHODS	The randomisation scheme was generated by Facet Biotech .
METHODS	All patients and assessors were masked to treatment with the exception of Facet Biotech bioanalysts who prepared data for the data safety monitoring board or generated pharmacokinetic or pharmacodynamic data , a drug accountability auditor , and the site pharmacist .
METHODS	The primary endpoint was total number of new or enlarged gadolinium contrast-enhancing lesions measured on brain MRI scans every 4 weeks between weeks 8 and 24 .
METHODS	Effects of daclizumab on prespecified subsets of lymphocytes and quantitative T-cell proliferative response were assessed in an exploratory pharmacodynamic substudy .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00109161 .
RESULTS	From May , 2005 , to March , 2006 , 288 patients were assessed for eligibility , and 230 were randomly assigned to receive interferon beta and high-dose daclizumab ( n = 75 ) , interferon beta and low-dose daclizumab ( n = 78 ) , or interferon beta and placebo ( n = 77 ) .
RESULTS	The adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 4.75 in the interferon beta and placebo group compared with 1.32 in the interferon beta and high-dose daclizumab group ( difference 72 % , 95 % CI 34 % to 88 % ; p = 0.004 ) and 3.58 in the interferon beta and low-dose daclizumab group ( 25 % , -76 % to 68 % ; p = 0.51 ) .
RESULTS	In the pharmacodynamic substudy , daclizumab was not associated with significant changes in absolute numbers of T cells , B cells , or natural killer cells , or T-cell proliferative response compared with interferon beta alone .
RESULTS	The number of CD56 ( bright ) natural killer cells was seven to eight times higher in both daclizumab groups than in the interferon beta and placebo group ( interferon beta and low-dose daclizumab group p = 0.002 ; interferon beta and high-dose daclizumab group p < 0.0001 ) .
RESULTS	Common adverse events were equally distributed across groups .
CONCLUSIONS	Add-on daclizumab treatment reduced the number of new or enlarged gadolinium contrast-enhancing lesions compared with interferon beta alone and might reduce multiple sclerosis disease activity to a greater extent than interferon beta alone .
BACKGROUND	Facet Biotech and Biogen Idec .

###17984668
BACKGROUND	The European Lacidipine Study on Atherosclerosis ( ELSA ) randomized 2334 hypertensive patients to either the lipophilic calcium antagonist lacidipine or the beta-blocker atenolol for 4 years .
BACKGROUND	About 35 % of subjects in both groups received additional hydrochlorothiazide ( 12.5-25 mg/day ) .
BACKGROUND	The patients were followed up for carotid intima-media thickness ( IMT ) changes for 3.7 years .
OBJECTIVE	The present post-hoc analyses were aimed at : describing the prevalence of the metabolic syndrome ( MS ) at baseline ; investigating the effect of long-term antihypertensive therapy ( and separately of atenolol and lacidipine ) on MS prevalence ; exploring whether MS at baseline influenced changes in carotid IMT and incidence of cardiovascular events during treatment ; and describing the relations between MS and new cases of diabetes developing during treatment .
METHODS	At baseline 2034 patients had , in addition to blood pressure ( BP ) , measurements of blood glucose , serum high-density lipoprotein ( HDL ) - cholesterol , triglycerides and body mass index ( BMI > 28.8 for men and > 26.2 for women were taken to correspond to waist circumference > 102 and > 88 cm , respectively ) .
METHODS	These measurements were repeated after 4 years of treatment in 1444 patients .
METHODS	MS was defined according to Adults Treatment Panel III ( ATP III ) .
RESULTS	A high proportion of ELSA patients ( 33.3 % ) had MS at baseline , with no difference between atenolol and lacidipine .
RESULTS	Baseline IMT was slightly greater in MS patients , but only the difference in mean maximum IMT at common carotids and bifurcations ( CBMmax ) achieved significance ( P = 0.0325 ) .
RESULTS	Progression of CBMmax was also slightly greater in MS patients ( P = 0.0241 ) , but significance was lost when adjusted for covariates .
RESULTS	No significant difference was found in the incidence of new cardiovascular events between patients with and without MS. The incidence of new MS was 21.4 % , and significantly greater in patients under atenolol ( 25.2 % ) than lacidipine ( 17.7 % ; P = 0.0045 ) .
RESULTS	New-onset diabetes occurred in 5.54 % of ELSA patients , and was three times higher among patients with than those without MS ( 10.28 versus 3.43 % , P > 0.0001 ) .
CONCLUSIONS	Our analyses show a high prevalence of MS in ELSA hypertensives , a substantial incidence of new cases of MS and diabetes , the latter mostly among patients with MS. These analyses also show that in ELSA lacidipine was superior to atenolol , not only in showing a lower progression of carotid atherosclerosis , but also in causing a significantly lower incidence of new MS.

###20932341
BACKGROUND	There are no proven therapies that modify the structural changes associated with osteoarthritis ( OA ) .
BACKGROUND	Preclinical data suggests that intra-articular recombinant human BMP-7 ( bone morphogenetic protein-7 ) has reparative effects on cartilage , as well as on symptoms of joint pain .
BACKGROUND	The objective of this study was to determine the safety and tolerability as well as dose-limiting toxicity and maximal tolerated dose of intra-articular BMP-7 .
BACKGROUND	The secondary objectives were to determine the effect on symptomatic responses through 24 weeks .
METHODS	This was a Phase 1 , double-blind , randomized , multi-center , placebo-controlled , single-dose escalation safety study consisting of 4 dosing cohorts in participants with knee OA .
METHODS	Each cohort was to consist of 8 treated participants , with treatment allocation in a 3:1 active ( intra-articular BMP-7 ) to placebo ratio .
METHODS	Eligible participants were persons with symptomatic radiographic knee OA over the age of 40 .
METHODS	The primary objective of this study was to determine the safety and tolerability of BMP-7 including laboratory assessments , immunogenicity data and radiographic assessments .
METHODS	Secondary objectives were to determine the proportion of participants with a 20 % , 50 % , and 70 % improvement in the WOMAC pain and function subscales at 4 , 8 , 12 , and 24 weeks .
METHODS	Other secondary outcomes included the change from baseline to 4 , 8 , 12 , and 24 weeks for the OARSI responder criteria .
RESULTS	The mean age of participants was 60 years and 73 % were female .
RESULTS	All 33 participants who were enrolled completed the study and most adverse events were mild or moderate and were similar in placebo and BMP-7 groups .
RESULTS	The 1 mg BMP-7 group showed a higher frequency of injection site pain and there was no ectopic bone formation seen on plain x-rays .
RESULTS	By week 12 , most participants in both the BMP-7 and placebo groups experienced a 20 % improvement in pain and overall the BMP-7 group was similar to placebo with regard to this measurement .
RESULTS	In the participants who received 0.1 mg and 0.3 mg BMP-7 , there was a trend toward greater symptomatic improvement than placebo .
RESULTS	The other secondary endpoints showed similar trends including the OARSI responder criteria for which the BMP-7 groups had more responders than placebo .
CONCLUSIONS	There was no dose limiting toxicity identified in this study .
CONCLUSIONS	The suggestion of a symptom response , together with the lack of dose limiting toxicity provide further support for the continued development of this product for the treatment of osteoarthritis .

###25090853
BACKGROUND	The article presents the results of psychosocial burdens in special educators ( specialists in the field of oligophrenopedagogy ) with intellectually disabled students .
BACKGROUND	In theoretical part , specific context of occupational stress in special educators was introduced .
BACKGROUND	Additionally , the need of broader research context regarding occupational stress and the risk of burnout in special educators working with intellectually disabled individuals were included .
METHODS	The results were obtained using Plichta and Pyzalski 's Questionnaire of Occupational Burdens in Teaching ( QOBT ) .
METHODS	The presented results are based on a research sample ( N = 100 ) of special educators ( female ) teaching intellectually disabled students attending special schools in the city of Ldz .
METHODS	The obtained results were compared with the results coming from a large random sample of public school teachers working with non-intellectually disabled children from the Lodi voivodeship ( N = 429 ) and referred to the norms of QOBT .
RESULTS	The results show significant percentage of respondents obtaining high level of occupational burdens ( conflict situations - 45 % , organizational burdens - 31 % , lack of work sense - 40 % , global score - 40 % ) .
RESULTS	Seniority is not related to the level of burdens .
RESULTS	Some significant differences concerning the level of occupational burdens between both groups of teachers were found .
CONCLUSIONS	The study showed e.g. the strong need for supporting special educators in the workplace context and the need of implementing preventive and remedial measures at both individual and organizational levels ( especially in terms of improving personal relationships in a workplace ) .
CONCLUSIONS	Generally , the results show similarity of the stressors ' ranking in special educators and school teachers working with non-intellectually disabled children .

###9836156
OBJECTIVE	To compare alcohol cleaning and natural drying of newborn umbilical cords .
METHODS	Prospective , randomized controlled trial .
METHODS	Tertiary-level university teaching hospital and level II community hospital .
METHODS	Of 1,876 singleton full-term newborns enrolled , 1,811 completed the study .
METHODS	Newborns , from birth until separation of the cord , were randomized to either ( a ) umbilical cleansing with 70 % isopropyl alcohol at each diaper change or ( b ) natural drying of the umbilical site without special treatment .
METHODS	Umbilical infection , cord separation time , maternal comfort , and cost .
RESULTS	No newborn in either group developed a cord infection .
RESULTS	Primary care providers obtained cultures for cord concerns in 32 newborns ( 1.8 % ) , with colonization for normal flora , Staphylococcus aureus , and Group B streptococcus proportionately equal in alcohol and air dry groups .
RESULTS	Cord separation time was statistically significantly different ( alcohol group , 9.8 days ; natural drying group , 8.16 days ; t = 8.9 , p = < .001 ) .
RESULTS	Mothers described similar comfort with cord care and relief with cord separation .
RESULTS	Costs of alcohol drying while in the hospital were greater than those of natural drying .
CONCLUSIONS	( a ) Evidence does not support continued use of alcohol for newborn cord care ; ( b ) health care providers should explain the normal process of cord separation , including appearance and possible odor ; and ( c ) health care providers should continue to develop evidence to support or eliminate historic practices .

###16900801
OBJECTIVE	Postsurgical pain in adults following tonsillectomy with fibrin sealant or electrocoagulation was assessed by surface electromyography ( sEMG ) , a dysphagia severity rating scale ( DSRS ) , and a visual analog scale ( VAS ) pain
METHODS	For group 1 ( n = 40 ) , hemostasis was achieved by fibrin sealant spraying to the tonsillar fossae .
METHODS	For group 2 ( n = 40 ) , hemostasis was achieved by bipolar or needle point electrocautery .
METHODS	The timing of single swallowing and continuous drinking and the mean electrical activity of the masseter , infrahyoid , and submental-submandibular muscles were compared with a normative database during 30 days and with DSRS and VAS scores .
RESULTS	Electrical activity of the masseter and infrahyoid muscles was significantly higher in both groups in comparison with the normative database ( p < .05 to p < .005 ) , whereas timing was less affected .
RESULTS	The combined sEMG , DSRS , and VAS assessment showed that tonsillectomy ended with sealant causes less pain than electrocoagulation ( p < .05 ) .
RESULTS	The DSRS score data were in strong positive correlation with the sEMG records , whereas the VAS pain score was less informative .
CONCLUSIONS	The combined sEMG and pain score data indicate that the electrocautery hemostatic technique is more painful and traumatic than the sealant technique .
CONCLUSIONS	Surface electromyography of swallowing is a simple , reliable evaluation method for postsurgical odynophagia complaints and might be used as an objective tool for pain assessment .

###12598392
OBJECTIVE	To investigate use of targeted self study material in type I diabetes patient education regarding dissemination , perceived patient benefit , and prevention of severe hypoglycaemia .
METHODS	In a randomised 1:1:1 controlled study , 332 patients with type I diabetes ( aged 2.6-18 .9 years ) were studied ; 313 completed clinical follow up , 261 completed endpoint questionnaire .
METHODS	The intervention group received videotapes and a brochure designed to review skills for self control and treatment , aimed at preventing severe hypoglycaemia .
METHODS	Two control groups received a videotape and brochure with general diabetes information , or traditional treatment only , respectively .
RESULTS	Yearly incidence of severe hypoglycaemia decreased from 42 % to 27 % in the intervention group , but not in controls .
RESULTS	HbA1c remained unchanged .
RESULTS	Levels of use ranged from 1 to 20 times ( median 2 ) ; 40-49 % had shown the materials to friends , relatives , school staff , sports coaches , etc ( there was little difference between intervention and control groups ) .
RESULTS	Higher benefit and learning levels resulted from the intervention material , especially in patients with severe hypoglycaemia .
CONCLUSIONS	Mass distributed pedagogical devices such as high quality video programmes and brochures may contribute to the prevention of severe hypoglycaemia .
CONCLUSIONS	Such self study materials can reach high dissemination levels and constitute a cost effective complement to regular visits to a diabetes team and to other types of education .
CONCLUSIONS	The findings may have implications for other topics , other ages , and other diagnosis groups .

###23356790
BACKGROUND	Despite the overall high degree of response to pharmacotherapy , consensus is lacking on how to judge clinical response or define optimal treatment/remission when treating adults with attention-deficit/hyperactivity disorder ( ADHD ) .
BACKGROUND	This study examined clinical response and symptomatic remission in analyses of 2 studies of lisdexamfetamine dimesylate ( LDX ) in adults with ADHD .
METHODS	In a 4-week , double-blind , forced-dose trial , adults with ADHD were randomized to LDX 30 , 50 , and 70 mg/day ( mg/d ) or placebo .
METHODS	In a second , open-label , follow-up trial , adults entering from the 4-week study were titrated to an `` optimal '' LDX dose ( 30 mg/d [ n = 44 ] , 50 mg/d [ n = 112 ] , and 70 mg/d [ n = 171 ] ) over 4 weeks , and maintained for 11 additional months .
METHODS	The ADHD Rating Scale IV ( ADHD-RS-IV ) with adult prompts and the Clinical Global Impressions-Improvement ( CGI-I ) scale assessed efficacy .
METHODS	Clinical response was defined , post hoc , as 30 % reduction from baseline in ADHD-RS-IV and CGI-I rating of 1 or 2 ; symptomatic remission was defined as ADHD-RS-IV total score 18 .
METHODS	Log rank analysis examined overall significance among the treatment groups in time to response or remission .
RESULTS	Four hundred and fourteen participants in the 4-week study and 345 in the open-label , extension study were included in the efficacy populations .
RESULTS	All LDX groups improved by ADHD-RS-IV and CGI-I scores in both studies .
RESULTS	In the 4-week study ( n = 414 ) , 69.3 % responded and 45.5 % achieved remission with LDX ( all doses ) ; 37.1 % responded and 16.1 % achieved remission with placebo ; time ( 95 % CI ) to median clinical response ( all LDX doses ) was 15.0 ( 15.0 , 17.0 ) days and to remission was 31.0 ( 28.0 , 37.0 ) days ( P < .0001 overall ) .
RESULTS	In the open-label study , with LDX ( all doses ) , 313 ( 95.7 % ) and 278 ( 85.0 % ) of 327 participants with evaluable maintenance-phase data met criteria for response and remission , respectively .
RESULTS	Of participants who completed dose optimization , 75.2 % remained responders and 65.7 % remained in remission in the 12-month study .
RESULTS	Overall , 285 ( 82.6 % ) and 227 ( 65.8 % ) of 345 participants were responders and remitters , respectively , at their final visits .
CONCLUSIONS	In the long-term study , with open-label , dose-optimized LDX treatment , most adults with ADHD achieved clinical response and/or symptomatic remission ; almost two-thirds maintained symptomatic remission over the remaining 11 months .
BACKGROUND	Clinical Trial Numbers : NCT00334880 and NCT01070394CLINICAL TRIAL REGISTRY : clinicaltrials.gov .

###20871194
OBJECTIVE	We aimed to study whether sedation reduces discomfort during endoscopy and a comparison of longer-acting diazepam with shorter-acting midazolam .
METHODS	A prospective , randomized , single-blinded study was conducted at the Department of Medicine at Government Medical College and Hospital , Chandigarh , and was completed over a period of 6 months .
METHODS	The patients were randomized to receive either placebo or sedation with midazolam or diazepam before endoscopy .
METHODS	The endoscopist and the observer recording patient 's / physician 's responses were blinded to the drugs administered .
METHODS	Two hundred and fifty two consecutive patients undergoing diagnostic or therapeutic upper gastrointestinal endoscopy were recruited .
METHODS	The patient 's discomfort and the physician 's comfort during the procedure were recorded on a visual analogue scale rated from 1-10 with-in 10 minutes of the procedure by an independent observer .
METHODS	The Patient 's discomfort ratings were further divided into 3 groups , comfortable ( score , 1-3 ) , satisfactory ( score , 4-7 ) and uncomfortable ( a score of > 7 ) .
METHODS	Similarly the physician 's ease of performing the procedure was also recorded on the same scale .
METHODS	This was again divided into 3 groups : easy ( score , 1-3 ) , satisfactory ( score , 4-7 ) and difficult ( a score of > 7 ) .
RESULTS	Out of the total of 252 patients , 82 patients received no sedation ( group I ) , 85 received diazepam ( group II ) and 85 received midazolam ( group III ) .
RESULTS	There was no statistical difference in the discomfort experienced by the patients during endoscopy when sedation was used ( P = 0.0754 ) .
RESULTS	Out of 252 patients , 49 underwent endoscopic procedures .
RESULTS	Nineteen patients were included in group I , 18 in group II and 12 in group III .
RESULTS	Only 10 ( 20 % ) patients undergoing endoscopic procedures complained of significant discomfort , but there was no difference in the ones undergoing interventions with or without sedation ( P = 0.854 ) .
RESULTS	The physicians were more comfortable in performing endoscopic procedure in sedated patients , however , the difference between patients in group II and group III was not statistically significant ( P = 0.0461 ) .
RESULTS	Both diazepam and midazolam fared equally well in increasing physician 's comfort ( P = 0.617 ) .
CONCLUSIONS	There was no difference in the patient 's discomfort with regard to the sedative used ( midazolam or diazepam ) .
CONCLUSIONS	Although endoscopy was easy or satisfactory in the majority of patients in the unsedated as well as the sedated groups , more often the endoscopist found it difficult to do endoscopy on the unsedated patients .

###20340011
BACKGROUND	S-citalopram ( escitalopram ) is the very active moiety of citalopram .
BACKGROUND	It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder ( MDD ) .
OBJECTIVE	The aim of our study was to compare the efficacy and safety of escitalopram vs citalopram in Chinese MDD patients .
METHODS	In the double-blind study , 240 MDD patients were randomly assigned to treatment for 6 weeks either with escitalopram ( 10-20 mg/d ) or citalopram ( 20-40 mg/d ) .
METHODS	The primary efficacy measurement was the change of 17-item Hamilton Depression Rating Scale ( HAMD-17 ) total score from baseline to the end of study .
METHODS	The secondary efficacy measurements were response and remission rates .
METHODS	The adverse events ( AEs ) were recorded by the investigator .
RESULTS	Two hundred and three ( 85 % ) patients completed the trial .
RESULTS	The average dose was 13.9 mg/d in the escitalopram group and 27.6 mg/d in the citalopram group .
RESULTS	No significant differences were found between the two groups in the change in HAMD-17 total score , response , and remission rate .
RESULTS	These results were similar in severe MDD patients .
RESULTS	No significant differences were found between the two groups in AEs .
RESULTS	No serious AEs were observed in this study .
CONCLUSIONS	The study suggests that escitalopram 10-20 mg/d are as effective and safe as citalopram 20-40 mg/d in the short-term treatment for Chinese MDD patients .

###16492297
BACKGROUND	The cardiovascular system ( CVS ) is heavily influenced by the autonomic nervous system .
BACKGROUND	Additionally , there is a functional alteration during the various stages of sleep .
BACKGROUND	In nonrapid eye movement ( NREM ) , a state of cardiovascular relaxation occurs during stages three and four .
BACKGROUND	A large amount of rapid ocular movements is concentrated in rapid eye movement ( REM ) sleep .
BACKGROUND	During this phase , fluctuations in arterial pressure ( AP ) and heart rate ( HR ) can be readily noted .
BACKGROUND	Sleep disordered breathing ( SDB ) has been associated with cardiac rhythm disorders .
BACKGROUND	Recently , cardiac rhythm disorder treatment with pacemaker ( PM ) highlighted a reduction in abnormal respiratory events during sleep .
OBJECTIVE	Comparison of sleep parameters of patients using PM with a sleep rate ( SR ) algorithm based on its rate-modulated capability during physical activity ( Integrity PM with SR function on and off ) .
METHODS	Twenty-two patients ( 14 women , 8 men ) , implanted with an Integrity PM ( St. Jude Medical Cardiac Rhythm Management Division , Sylmar , CA ) with SR function for standard clinical indications , were evaluated utilizing a double-blind protocol .
METHODS	The indication for pacing included sinus node disease ( SND ) , atrium ventricular blockage ( AVB ) , and atrial fibrillation ( AF ) .
METHODS	Following randomization , half of our patients had SR function switched to `` on '' mode while the other half were on `` off '' mode .
METHODS	During the first stage of the protocol , all patients underwent two consecutive nights of polysomnographic sleep recordings ( PSG ) .
METHODS	During the first night patients slept in the sleep lab only for adaptation purpose .
METHODS	PSG full recording was carried out in the subsequent night .
METHODS	At a later stage , the programing of SR functions was shifted to `` on '' or `` off '' modes .
METHODS	One week later , a third assessment was undertaken .
RESULTS	Twelve patients ( 54 % ) showed sleep efficiency improvement ( total sleeping time/recording time ) with PM SR on .
RESULTS	This group had the least effective sleep efficiency with PM off , if compared with the others who highlighted no change in this sleep parameter ( 72 + / - 12 vs 81 + / - 7 % , P = 0.01 , respectively ) .
RESULTS	This first group displayed a lower latency for REM sleep than the last one ( 89 + / - 55 vs 174 + / - 107 minutes , P = 0.01 , respectively ) .
RESULTS	In 11 ( 50 % ) patients , the number per sleep hour of microarousals was reduced when PM SR was switched on .
RESULTS	When we compared such findings to the group whose parameters had not changed , we noted that the first set of patients were sleepier ( ESE : 9 + / - 4 vs 5 + / - 5 , P = 0.04 , respectively ) , and showed more microarousals with PM SR off ( 20 + / - 14 vs 7 + / - 5 microarousal/hour , P = 0.007 ) .
CONCLUSIONS	In PM patients with sleep-related issues , the SR function activation improved sleep both from a qualitative and quantitative perspective .

###20025830
OBJECTIVE	We evaluated the effects of peanut consumption on lipid profiles , atherogenic index of plasma ( AIP ) and CHD risk in hypercholesterolaemic men .
METHODS	Randomised crossover clinical trial .
METHODS	Participants were randomly assigned to two groups .
METHODS	They were asked to consume peanut supplements ( about 77 g ) with their habitual diet for 4 weeks .
METHODS	Fifty-four hypercholesterolaemic men with total cholesterol ( TC ) concentrations between 200 and 350 mg/dl .
RESULTS	Compared with the habitual diet , peanut supplementation of the habitual diet significantly reduced TC/HDL cholesterol ( HDL-C ) ratio ( mean 1 ( se 0.3 ) P = 0.001 ) and LDL cholesterol ( LDL-C ) / HDL-C ratio ( mean 0.7 ( se 0.2 ) ; P = 0.001 ) .
RESULTS	Peanut consumption increased HDL-C ( mean 6.1 ( se 1.5 ) mg/dl ; P < 0.001 ) and total antioxidant capacity ( TAC ) ( mean 1.2 ( se 0.6 ) U/mL P = 0.04 ) .
RESULTS	In addition , peanut consumption significantly reduced the AIP ( mean 0.1 ( se 0.03 ) P = 0.01 ) and CHD estimated risk over 10 years based on systolic and diastolic blood pressures ( mean 1.4 % ( se 0.5 % ) P = 0.004 and mean 2.2 % ( se 0.5 % ) P < 0.001 , respectively ) .
CONCLUSIONS	Short-term peanut consumption might improve lipid profiles , the AIP and CHD risk in free-living hypercholesterolaemic men .

###16981914
BACKGROUND	Programmed electrical stimulation of the heart as a method to induce tachyarrhythmias has been described since the 1960s .
BACKGROUND	To date , no study has examined optimal drive cycle length in the induction of ventricular fibrillation ( VF ) during defibrillation threshold testing after implantable cardioverter-defibrillator placement .
BACKGROUND	We hypothesized that longer drive cycle length , by means of the longer action potential duration , would promote intramyocardial phase 2 reentry and facilitate induction of VF .
METHODS	Fifty consecutive implants were randomized in a prospective crossover format for this study .
METHODS	The group consisted of 40 men and 10 women , with each patient receiving either a 400 or 600 ms initial drive train prior to 1.2 J internal shock on the T wave with a goal to induce ventricular fibrillation .
METHODS	The timing of the T wave shock was determined by measuring the interval from the beginning of the QRS to the apex of the T wave in lead II .
METHODS	Successful inductions were defibrillated via the cardioverter defibrillator .
METHODS	Patients were then crossed over and the protocol repeated .
RESULTS	Twenty of 23 ( 87 % ) patients were successfully induced into VF in the initial 400 ms drive train arm whereas 22 of 27 ( 81 % ) were successfully induced in the 600 ms arm .
RESULTS	Thus , a total of 44 ( 88 % ) patients were successfully induced at 400 ms , 41 ( 82 % ) patients were successfully induced at 600 ms , and 2 ( 4 % ) patients were not inducible at either cycle length , but were inducible with 50 Hz ventricular stimulation .
RESULTS	However , no significant difference was noted between the two groups .
CONCLUSIONS	No investigation to date has questioned whether a relationship exists between drive cycle length and initiation of ventricular fibrillation .
CONCLUSIONS	Our study addresses this question , though negative for difference between 400 and 600 ms drive trains .
CONCLUSIONS	Further research into optimal strategies for inducing ventricular fibrillation will minimize patient sedation time and discomfort while undergoing defibrillator threshold testing .

###22866283
OBJECTIVE	To evaluate the anti-plaque and anti-gingivitis properties of Acacia arabicacontaining toothpaste in an adult population .
METHODS	Sixty subjects with gingivitis were randomly assigned to a test group ( Acacia arabica-containing toothpaste ) or control group ( regular toothpaste ) .
METHODS	An analysis of plaque index ( PI ) , gingival index ( GI ) and bleeding on probing index ( BOP % ) were carried out at baseline and after 28 days followed by a washout period .
METHODS	After the washout period , the test and control groups were crossed over and the assessments were repeated .
RESULTS	Reductions in PI , GI and BOP % were observed in the test group compared with the control group .
CONCLUSIONS	Brushing with Acacia arabica-containing toothpaste may help inhibit gingivitis .
CONCLUSIONS	It can be recommended for daily oral hygiene procedures .

###24531843
OBJECTIVE	To compare the effects of different arm positions on dose exposure and image quality ( IQ ) in cervical spine CT after trauma in different patient groups .
METHODS	Patients in standard ( STD = 126 ) and in swimmer 's position ( SWIM = 254 ) were included .
METHODS	Body mass index ( BMI subgroup 1 = underweight to subgroup 4 = obese ) , anterior-posterior diameter ( AP ) , left-right diameter ( LR ) , area of an ellipse ( AoE ) and angle between the humeral heads ( optimal STD < 3 , optimal SWIM > 10 ) were used as grouping criteria .
METHODS	Computed tomography dose index ( CTDI ) was documented .
METHODS	Two radiologists rated the IQ at three levels ( CV1/2 , CV4/5 , CV7/T1 ) using a semi-quantitative scale ( 0 = not diagnostic , 1 = diagnostic with limitations , 2 = diagnostic without limitations ) .
METHODS	The Mann-Whitney U test correlations of grouping criteria with dose effects and intra-class correlation ( ICC ) were calculated .
RESULTS	ICC was 0.87 .
RESULTS	BMI grouping showed the strongest correlation with dose effects : CTDI of optimal STD versus optimal SWIM positioning was 3.17 mGy versus 2.46 mGy ( subgroup 1 ) , 5.47 mGy versus 3.97 mGy ( subgroup 2 ) , 7.35 mGy versus 5.96 mGy ( subgroup 3 ) and 8.71 mGy versus 8.18 mGy ( subgroup 4 ) .
RESULTS	Mean IQ at CV7/T1 was 1.65 versus 1.23 ( subgroup 1 ) , 1.27 versus 1.46 ( subgroup 2 ) , 1.06 versus 1.46 ( subgroup 3 ) , 0.79 versus 1.5 ( subgroup 4 ) .
CONCLUSIONS	Patients with a BMI > 20 kg/m ( 2 ) benefited from both potential dose reduction and improved image quality at the critical cervicothoracic junction when swimmer 's position was used .
CONCLUSIONS	BMI is a useful metric for personalized optimization in CT for the c-spine .
CONCLUSIONS	Using swimmer 's position , patients can benefit from dose reduction .
CONCLUSIONS	In some patients a superior image quality can be achieved with swimmer 's position .
CONCLUSIONS	For swimmer 's positioning an angle of more than 10 is optimal .

###20053673
OBJECTIVE	To assess the effectiveness of an intervention after comprehensive geriatric assessment ( CGA ) in reducing morbidity and mortality in patients over 74 years in primary care .
METHODS	Randomized controlled trial with 18 months of follow-up .
METHODS	Patients in the control group ( CG ) followed usual care .
METHODS	Patients in the intervention group ( IG ) were classified as at risk or non-risk of frailty based on the CGA .
METHODS	Patients at non-risk of frailty in the IG were provided with recommendations about healthy habits and adherence to treatment in group sessions , while patients at risk of frailty were visited individually by a geriatrician .
RESULTS	Six hundred and twenty patients were randomized to the IG ( 49.7 % ) or to the CG ( 50.3 % ) , 83.2 % completed follow-up .
RESULTS	Cox 's proportional hazards model showed as covariates the study group ( hazard ratio [ HR ] 0.58 ; 95 % confidence interval [ CI ] 0.28-1 .22 ) , risk of frailty ( HR 1.33 ; 95 % CI 0.71-2 .51 ) and the interaction between both ( HR 3.08 ; 95 % CI 1.22-7 .78 ) .
RESULTS	Forty-nine percent of the patients in the IG and 43 % in the CG were at risk of frailty at baseline .
RESULTS	At the end of the study , 27.9 % of the IG and 13.5 % of the CG had reversed their initial at risk of frailty status ( P = 0.027 ) .
RESULTS	Multivariate predictors of reversible risk of frailty were younger age , not being at risk of depression , low consumption of medications and the intervention itself .
CONCLUSIONS	A specific intervention in patients over 74 years attended in primary care reduces morbidity and mortality in patients at risk of frailty and increases the proportion of patients that reversed their initial status at risk of frailty .

###12743670
OBJECTIVE	To investigate the usefulness of the 3-hydroxylation of quinine as a biomarker reaction for the activity of CYP3A4 in man and to study the interindividual variation in the metabolic ratio ( MR ) , i.e. quinine/3-hydroxyquinine .
METHODS	Data from a previous study ( A ) was used for determination of the MR of quinine in plasma and urine at different time points .
METHODS	In study B , 24 healthy Swedish subjects received 250 mg quinine hydrochloride first alone and later together with four other CYP probe drugs [ losartan ( CYP2C9 ) , omeprazole ( CYP2C19 ) , debrisoquine ( CYP2D6 ) and caffeine ( CYP1A2 ) ] administered on the same day .
METHODS	Plasma and urine samples were collected before quinine intake and 16 h thereafter and analysed for quinine and 3-hydroxyquinine using high-performance liquid chromatography .
METHODS	Plasma and/or urine were collected for the other probes at different time points .
METHODS	MRs of all the probes were determined and correlations to quinine MR were studied .
RESULTS	In study A , the MR in plasma was stable over 96 h.
RESULTS	The ratio increased from 5.8 to 12.2 ( P = 0.006 ) during co-administration with ketoconazole , whereas no significant difference ( P = 0.76 ) was observed during co-administration with fluvoxamine ( from 5.8 to 6.0 ) .
RESULTS	In study B , there was no significant difference ( P = 0.36 ) between the mean MRs when quinine was given alone ( 4.7 ) or together with the four other drugs ( 4.5 ) .
RESULTS	There was a significant correlation between the MR of quinine and omeprazole sulphone formation ( r = 0.52 , P < 0.01 ) , but not to the MRs of the other probes .
RESULTS	There was a fivefold interindividual variability in the MR.
CONCLUSIONS	The MR of quinine in plasma or urine may serve as a stable measure of the activity of CYP3A4 in man .
CONCLUSIONS	These results together with in vitro data show that quinine is also a specific CYP3A4 probe .

###10507814
OBJECTIVE	To investigate peritoneal defense during icodextrin use in continuous cyclic peritoneal dialysis ( CCPD ) .
METHODS	In an open , prospective , 2-year follow-up study , CCPD patients were randomized to either glucose ( Glu ) or icodextrin ( Ico ) for their long daytime dwell .
METHODS	University hospital and teaching hospital .
METHODS	Both established and patients new to CCPD were included .
METHODS	A life expectancy of more than 2 years , a stable clinical condition , and written informed consent were necessary before entry .
METHODS	Patients aged under 18 years , those who had peritonitis in the previous month , and women of childbearing potential , unless taking adequate contraceptive precautions , were excluded .
METHODS	Thirty-eight patients ( 19 Glu , 19 Ico ) started the study .
METHODS	The median follow-up was 16 and 17 months for Glu and Ico respectively ( range 0.5-25 months and 5-25 months , respectively ) .
METHODS	Peritoneal defense characteristics and peritoneal dialysis-related infections were recorded every 3 months .
RESULTS	Total peritoneal white cell count tended to decrease over time in both groups .
RESULTS	After 1 year , absolute numbers and percentages of effluent peritoneal macrophages ( PMphis ) were significantly higher in Ico than in Glu patients ; this difference in the percentage persisted after 2 years .
RESULTS	Percentage of mesothelial cells increased overtime in Ico patients .
RESULTS	The phagocytic capacity of PMphis decreased over time , resulting in a borderline significant difference for coagulase-negative staphylococci ( p = 0.05 ) and a significant difference for Escherichia coli ( p < 0.05 ) phagocytosis in favor of Ico patients .
RESULTS	PMphi oxidative metabolism remained stable over time without a difference between the groups .
RESULTS	PMphi cytokine production and effluent opsonic capacity also remained stable over time .
RESULTS	Finally , 16 peritonitis episodes in Glu and 14 in Ico patients occurred .
RESULTS	Glucose patients had 37 and Ico patients 32 exit-site infections during the study .
CONCLUSIONS	CCPD patients using Ico did equally as well as Glu-treated patients with respect to clinical infections and most peritoneal defense characteristics .
CONCLUSIONS	However , in a few peritoneal defense tests , Ico-treated patients did better .

###19765502
BACKGROUND	Vietnamese-American women underutilize breast cancer screening .
METHODS	An RCT was conducted comparing the effect of lay health workers ( LHWs ) and media education ( ME ) to ME alone on breast cancer screening among these women .
METHODS	Conducted in California from 2004 to 2007 , the study included 1100 Vietnamese-American women aged > or = 40 years who were recruited through LHW social networks .
METHODS	Data were analyzed from 2007 to 2009 .
METHODS	Both groups received targeted ME .
METHODS	The intervention group received two LHW educational sessions and two telephone calls .
METHODS	Change in self-reported receipt of mammography ever , mammography within 2 years , clinical breast examination ( CBE ) ever , or CBE within 2 years .
RESULTS	The LHW+ME group increased receipt of mammography ever and mammography in the past 2 years ( 84.1 % to 91.6 % and 64.7 % to 82.1 % , p < 0.001 ) while the ME group did not .
RESULTS	Both ME ( 73.1 % to 79.0 % , p < 0.001 ) and LHW+ME ( 68.1 % to 85.5 % , p < 0.001 ) groups increased receipt of CBE ever , but the LHW+ME group had a significantly greater increase .
RESULTS	The results were similar for CBE within 2 years .
RESULTS	In multivariate analyses , LHW+ME was significantly more effective than ME for all four outcomes , with ORs of 3.62 ( 95 % CI = 1.35 , 9.76 ) for mammography ever ; 3.14 ( 95 % CI = 1.98 , 5.01 ) for mammography within 2 years ; 2.94 ( 95 % CI = 1.63 , 5.30 ) for CBE ever ; and 3.04 ( 95 % CI = 2.11 , 4.37 ) for CBE within 2 years .
CONCLUSIONS	Lay health workers increased breast cancer screening among Vietnamese-American women.Future research should focus on how LHWs work and whether LHW outreach can be disseminated to other ethnic groups [ corrected ] .

###24720702
BACKGROUND	High rates of sustained virologic response were observed among patients with hepatitis C virus ( HCV ) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir .
BACKGROUND	This study examined 8 weeks of treatment with this regimen .
METHODS	In this phase 3 , open-label study , we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir ( ledipasvir-sofosbuvir ) for 8 weeks , ledipasvir-sofosbuvir plus ribavirin for 8 weeks , or ledipasvir-sofosbuvir for 12 weeks .
METHODS	The primary end point was sustained virologic response at 12 weeks after the end of therapy .
RESULTS	The rate of sustained virologic response was 94 % ( 95 % confidence interval [ CI ] , 90 to 97 ) with 8 weeks of ledipasvir-sofosbuvir , 93 % ( 95 % CI , 89 to 96 ) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin , and 95 % ( 95 % CI , 92 to 98 ) with 12 weeks of ledipasvir-sofosbuvir .
RESULTS	As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir , the rate in the 12-week group was 1 percentage point higher ( 97.5 % CI , -4 to 6 ) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower ( 95 % CI , -6 to 4 ) ; these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen , on the basis of a noninferiority margin of 12 percentage points .
RESULTS	Adverse events were more common in the group that received ribavirin than in the other two groups .
RESULTS	No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events .
CONCLUSIONS	Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis .
CONCLUSIONS	No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks .
CONCLUSIONS	( Funded by Gilead Sciences ; ION-3 ClinicalTrials.gov number , NCT01851330 . )

###10480503
OBJECTIVE	To compare the immunologic response to insulin lispro with that to regular human insulin , thereby assuring its safety for use in women with gestational diabetes , and to verify that it is effective .
METHODS	We compared the metabolic and immunologic effects of insulin lispro and regular human insulin in 42 women > 18 years of age diagnosed with gestational diabetes by oral glucose tolerance testing at 14-32 weeks of gestation .
METHODS	Patients were randomized to receive regular human insulin or insulin lispro before consuming a test meal .
METHODS	Serum insulin , blood glucose , and C-peptide concentrations were measured .
METHODS	Throughout the remainder of gestation , patients received premeal insulin lispro or regular human insulin combined with basal insulin and performed blood glucose self-monitoring before and after each meal .
METHODS	Insulin antibodies and HbA1c were determined at enrollment and 6 weeks later .
METHODS	In addition , 10 patients received continuous intravenous insulin ( 4 lispro , 6 regular human insulin ) and dextrose infusions intrapartum to assess placental insulin transfer .
RESULTS	Anti-insulin antibody levels were similar in the two groups .
RESULTS	Insulin lispro was not detectable in the cord blood .
RESULTS	During a meal test , areas under the curve for glucose , insulin , and C-peptide were significantly lower in the lispro group .
RESULTS	Mean fasting and postprandial glucose concentrations and end point HbA1c were similar in the two groups .
RESULTS	The lispro group demonstrated fewer hypoglycemic episodes ( symptoms and blood glucose concentrations < 55 mg/dl ) .
RESULTS	No fetal or neonatal abnormalities were noted in either treatment group .
CONCLUSIONS	Insulin lispro may be considered a treatment option for women with gestational diabetes .

###24447534
BACKGROUND	Sildenafil citrate is indicated for the treatment of erectile dysfunction .
BACKGROUND	An orally disintegrating tablet ( ODT ) of sildenafil citrate has been developed for the benefit of patients who have difficulty swallowing solid dosage forms .
OBJECTIVE	The main goal of this study was to evaluate the bioequivalence of sildenafil ODT with and without water versus marketed sildenafil oral film-coated tablets .
OBJECTIVE	A secondary objective was to evaluate the effects of a high-fat meal on the pharmacokinetics of sildenafil ODT .
METHODS	The bioequivalence study of sildenafil ODT given with and without water versus marketed sildenafil citrate film-coated oral tablets was conducted in 36 subjects .
METHODS	In a food-effect study , the effect of a standard high-fat meal on the pharmacokinetics of sildenafil ODT was evaluated in 12 subjects .
METHODS	Both studies were randomized , open-label , crossover , single-dose ( 50 mg ) studies in healthy men aged 45 years .
METHODS	Plasma samples were collected for 14 hours postdose , and pharmacokinetics were determined by using noncompartmental analyses .
RESULTS	All subjects in both studies were Asian males between the ages of 45 and 69 years .
RESULTS	Sildenafil ODT without water was bioequivalent to the marketed sildenafil film-coated oral tablet as the 90 % CI for the ratio of geometric means of Cmax , AUC0 - , and AUC0-last were contained within equivalence limits ( 80 % -125 % ) .
RESULTS	When sildenafil ODTs were given with water , the 90 % CIs for sildenafil AUC0 - and AUC0-last were contained within the range of 80 % to 125 % ; however , the 90 % CI for sildenafil Cmax was not ( 79.76-92 .78 ) .
RESULTS	This difference in Cmax is unlikely to have any clinically meaningful impact .
RESULTS	High-fat meals reduced the rate but not the extent of absorption of sildenafil .
RESULTS	Mean Cmax was reduced by 59 % , and median Tmax was delayed from 0.625 hour ( fasting ) to 4 hours ( high-fat meal ) .
RESULTS	However , AUC values were comparable between fed and fasted treatments .
CONCLUSIONS	Sildenafil ODT , given with or without water , provides equivalent systemic exposure compared with marketed sildenafil film-coated oral tablets , thus offering a convenient alternative method of administration .
CONCLUSIONS	Considering the results of the food-effect study , sildenafil ODT should be taken on an empty stomach .
CONCLUSIONS	ClinicalTrials.gov identifiers : NCT01254383 ( bioequivalence ) and NCT01254396 ( food effect ) .

###22791282
OBJECTIVE	The hypothesis was that the daily use of a high dose of a xylitol chewing gum for 6 months would reduce the increment of decayed permanent first molar surfaces ( D6S ) in high-risk schoolchildren after 2 years .
METHODS	In this randomised , clinical trial , 204 schoolchildren with a high caries risk were assigned to two experimental groups , xylitol and non-xylitol .
METHODS	Caries status , salivary mutans streptococci , and lactobacilli were re-evaluated 2 years later in 74 xylitol-treated and 83 non-xylitol-treated schoolchildren .
METHODS	Differences in mean D6S between groups registered at baseline and at follow-up were evaluated using the nonparametric Mann-Whitney U test .
RESULTS	Outcome was the development of detectable carious lesions initial ( D1-D2 ) and manifest ( D3 ) in the permanent first molars .
RESULTS	In the xylitol group , the difference in proportion of children with decayed first permanent molars at baseline and follow-up was 1.43 % for manifest lesion and 2.86 % for initial lesions ; while in the non-xylitol group was 10.26 % ( p < 0.01 ) and 16.66 % ( p < 0.01 ) , respectively .
RESULTS	A statistically significant difference regarding means was also observed in the non-xylitol group : the D6S for manifest lesion was 0.18 ( p = 0.03 ) and 0.67 ( p = 0.02 ) for initial lesion .
CONCLUSIONS	The use of a chewing gum containing a high dose of xylitol for a period of 6 months has been shown to produce a long-term effect on caries development in high caries-risk children .
CONCLUSIONS	A school-based preventive programme based on 6 months ' administration of a high dose of xylitol via chewing gum proved to be efficacious in controlling caries increment in high-risk children .

###21418630
BACKGROUND	The clinical environment in which health care providers have to work everyday is highly complex ; this increases the risk for the occurrence of unintended events .
BACKGROUND	The aim of this randomised controlled trial is to improve patient safety for a vulnerable group of patients that have to go through a complex care chain , namely elderly hip fracture patients .
METHODS	A randomised controlled trial that consists of three interventions ; these will be implemented in three surgical wards in Dutch hospitals .
METHODS	One surgical ward in another hospital will be the control group .
METHODS	The first intervention is aimed at improving communication between care providers using the SBAR communication tool .
METHODS	The second intervention is directed at stimulating the role of the patient within the care process with a patient safety card .
METHODS	The third intervention consists of a leaflet for patients with information on the most common complications for the period after discharge .
METHODS	The primary outcome measures in this study are the incidence of complications and adverse events , mortality rate within six months after discharge and functional mobility six months after discharge .
METHODS	Secondary outcome measures are length of hospital stay , quality and completeness of information transfer and patient satisfaction with the instruments .
CONCLUSIONS	The results will give insight into the nature and scale of complications and adverse events that occur in elderly hip fracture patients .
CONCLUSIONS	Also , the implementation of three interventions aimed at improving the communication and information transfer provides valuable possibilities for improving patient safety in this increasing patient group .
CONCLUSIONS	This study combines the use of three interventions , which is an innovative aspect of the study .
BACKGROUND	The Netherlands National Trial Register NTR1562 .

###18540923
BACKGROUND	Insomnia and other sleep disturbances are common , persistent , and associated with relapse in alcohol-dependent patients .
BACKGROUND	The purpose of this pilot study was to compare gabapentin versus placebo for the treatment of insomnia and prevention of relapse in alcohol-dependent patients .
METHODS	Twenty-one subjects , including 10 women who met study criteria for alcohol dependence and insomnia and expressed a desire to abstain from alcohol , were recruited to the study .
METHODS	During a 1 to 2 week placebo lead-in and screening phase , a complete medical history , physical exam , blood tests , urine drug test , and structured interviews were performed to determine eligibility and patterns of alcohol use and sleep .
METHODS	Insomnia due to intoxication or acute withdrawal , psychiatric or medical illness , medications , and other sleep disorders were ruled out .
METHODS	Subjects were then randomized to either placebo ( n = 11 ) or gabapentin ( n = 10 ) for 6 weeks and titrated over a 10-day period to 1,500 mg or 5 pills at bedtime .
METHODS	After a 4-day taper , subjects were reassessed 6 weeks after ending treatment .
RESULTS	Gabapentin significantly delayed the onset to heavy drinking , an effect which persisted for 6 weeks after treatment ended .
RESULTS	Insomnia improved in both treatment groups during the medication phase , but gabapentin had no differential effects on sleep as measured by either subjective report or polysomnography .
CONCLUSIONS	Because gabapentin is a short-acting medication that was taken only at nighttime in this study , it may possibly exert a nocturnal effect that prevents relapse to heavy drinking by a physiological mechanism not measured in this pilot study .

###14578723
OBJECTIVE	To investigate the effect of a restricted intravenous fluid regimen versus a standard regimen on complications after colorectal resection .
BACKGROUND	Current fluid administration in major surgery causes a weight increase of 3-6 kg .
BACKGROUND	Complications after colorectal surgery are reported in up to 68 % of patients .
BACKGROUND	Associations between postoperative weight gain and poor survival as well as fluid overload and complications have been shown .
METHODS	We did a randomized observer-blinded multicenter trial .
METHODS	After informed consent was obtained , 172 patients were allocated to either a restricted or a standard intraoperative and postoperative intravenous fluid regimen .
METHODS	The restricted regimen aimed at maintaining preoperative body weight ; the standard regimen resembled everyday practice .
METHODS	The primary outcome measures were complications ; the secondary measures were death and adverse effects .
RESULTS	The restricted intravenous fluid regimen significantly reduced postoperative complications both by intention-to-treat ( 33 % versus 51 % , P = 0.013 ) and per-protocol ( 30 % versus 56 % , P = 0.003 ) analyses .
RESULTS	The numbers of both cardiopulmonary ( 7 % versus 24 % , P = 0.007 ) and tissue-healing complications ( 16 % versus 31 % , P = 0.04 ) were significantly reduced .
RESULTS	No patients died in the restricted group compared with 4 deaths in the standard group ( 0 % versus 4.7 % , P = 0.12 ) .
RESULTS	No harmful adverse effects were observed .
CONCLUSIONS	The restricted perioperative intravenous fluid regimen aiming at unchanged body weight reduces complications after elective colorectal resection .

###23513469
OBJECTIVE	To determine the efficacy of fresh lime as a smoking cessation aid compared with nicotine gum .
METHODS	A randomized , controlled trial was conducted between March 2009 and September 2009 .
METHODS	Only regular smokers aged 18 or older who were willing to quit were randomized to receive either fresh lime ( n = 47 ) or nicotine gum ( n = 53 ) .
METHODS	Smokers were excluded if they were using other smoking cessation aids , allergic to citrus , or had dental problems .
METHODS	Exhaled carbon monoxide ( CO ) - confirmed continuous abstinence rate ( CAR ) during week 9-12 was measured as the primary outcomes .
METHODS	To grade the severity of craving , a 100-mm visual analogue scale ( VAS ) was used .
RESULTS	There was no significant difference in CO-confirmed CAR between the fresh lime group and the nicotine gum group during weeks 9-12 ( 61.7 % vs. 66.0 % ; p = 0.65 ) , although 7-day point prevalence abstinence at week 4 of the fresh lime users was statistically significant lower than those using nicotine gum ( 38.3 % vs. 58.5 % ; p = 0.04 ) .
RESULTS	Cravings did not differ significantly between the groups , although fresh lime users tend to report more cravings intensity .
CONCLUSIONS	Fresh lime can be used effectively as a smoking cessation aid , although not as good as nicotine gum in reducing cravings .

###17021748
OBJECTIVE	A remarkable incidence of failures after stapled axopexy ( SA ) for hemorrhoids has been recently reported by several papers , with an incomplete resection of the prolapsed tissue , due to the limited volume of the stapler casing as possible cause .
OBJECTIVE	The stapled transanal rectal resection ( STARR ) was demonstrated to successfully cure the association of rectal prolapse and rectocele by using two staplers .
OBJECTIVE	The aim of this randomized study was to evaluate the incidence of residual disease after SA and STARR in patients affected by prolapsed hemorrhoids associated with rectal prolapse .
METHODS	Sixty-eight patients were selected on the basis of validated constipation and continence scorings , clinical examination , colonoscopy , anorectal manometry , and defecography and randomized : 34 underwent a SA and 34 a STARR operation .
METHODS	The operated patients were followed-up with clinical examination , visual analog scale for postoperative pain , a satisfaction index , and defecography .
RESULTS	At a mean follow-up of 8.1 + / -2.0 and 7.9 + / -1.8 months for the SA and STARR groups , respectively , the incidence of residual disease was significantly higher in the first group ( 29.4 vs 5.9 in the STARR group , p = 0.007 ) , while a significantly lower incidence of residual skin-tags was found after STARR ( 23.5 % vs 58.8 after SA , p = 0.03 ) .
RESULTS	All patients with residual disease showed prolapsed tissue over half the length of the anal dilator at the time of the operation .
RESULTS	Operative time and incidence of transient fecal urgency were significantly higher in the STARR group ( with p = 0.001 and 0.08 , respectively ) , while SA was followed by a significantly higher incidence of poor results at the overall patient satisfaction index ( p = 0.04 ) .
RESULTS	No significant differences were found in hospital stay , operative complications , postoperative pain , time to return to normal activity , continence , and constipation scores .
RESULTS	All the defecographic parameters significantly improved after STARR , while SA was followed only by a trend to a reduction of rectal prolapse .
CONCLUSIONS	STARR provides a more complete resection of the prolapsed tissue than SA in patients with association of prolapsed hemorrhoids and rectal prolapse with equal morbidity and significantly lower incidence of residual disease and skin-tags .
CONCLUSIONS	The anal dilator can be used for selecting the surgical technique .

###23557411
BACKGROUND	Octreotide is generally administered based on the surgeon 's interpretation of perceived risk for pancreatic fistula at the time of pancreaticoduodenectomy ( PD ) .
METHODS	A single-institution , prospective randomized trial was conducted between April 2009 and December 2011 involving 62 PD patients who were randomized to receive octreotide ( 100 g subcutaneously every 8 h ; n = 32 ) or placebo ( n = 30 ) .
METHODS	Pancreatic juice output was measured after the operation using a catheter inserted into the pancreatic duct .
METHODS	Postoperative complications were recorded .
RESULTS	No significant differences in median output were found between the octreotide ( 82.5 ml ) and placebo ( 77.5 ml ) groups ( P = 0.538 ) .
RESULTS	Median total output was significantly lower in patients with adenocarcinoma compared with those with periampullary tumours ( P = 0.004 ) and in patients with a duct diameter of > 5 mm compared with those with a duct diameter of < 5 mm ( P = 0.001 ) .
RESULTS	There were no significant differences in overall morbidity between the octreotide and placebo groups ( P = 0.819 ) .
RESULTS	Grade B pancreatic fistula ( International Study Group for Pancreatic Fistula ) was observed in two and three patients in the octreotide and placebo groups , respectively .
CONCLUSIONS	Morbidity did not differ significantly between the groups .
CONCLUSIONS	This study did not demonstrate an inhibitory effect of octreotide on exocrine pancreatic secretion .
CONCLUSIONS	Based on these results , the routine use of octreotide after PD can not be recommended .

###15658652
OBJECTIVE	To explore the effect and mechanism of Shenqi Fuzheng injection ( SFI ) on renal tubule in treating patients with primary nephrotic syndrome ( PNS ) .
METHODS	Eighty patients with PNS were randomly divided into two groups , 40 patients in the control group were treated by conventional therapy mainly with glucocorticoids ; 40 patients in the treated group treated by conventional therapy plus intravenous injection of SFI additionally .
METHODS	The changes of serum albumin ( sALB ) , urinary protein in 24 hrs ( UP/24h ) , urinary levels of retinal binding protein ( RBP ) , beta2 microglobulin ( beta2-MG ) and N-acetyl-D-glucosaminidase ( NAG ) as well as blood lipids before and after treatment were observed .
RESULTS	After treatment , level of sALB increased and urinay levels of RBP , beta2-MG , NAG , UP/24h decreased in the treated group , as compared with those in the control group , showing significant difference ( P < 0.05 or P < 0.01 ) .
RESULTS	Blood lipids level abated significantly after treatment in both groups ( P < 0.01 ) , comparison between them , levels of TC and LDL-C in the treated group were significantly lower than those in the control group ( P < 0.01 ) .
CONCLUSIONS	SFI has protective effect on renal tubule in patients with PNS , also has effect on lowering blood lipids .

###11275038
OBJECTIVE	To investigate whether central diathermy ball cauterization after loop excision affects satisfactory colposcopy at follow-up .
METHODS	One hundred one consecutive women with the squamocolumnar junction visible at the ectocervix scheduled for loop excision were assigned alternately into two groups .
METHODS	In group A , diathermy ball cauterization was applied to the entire crater following excision .
METHODS	In group B , cauterization was avoided in a 2-3-mm zone around the new os .
METHODS	The women were re-examined 4 months postoperatively by colposcopy and microcolpohysteroscopy with specific intention to identify the location of the squamocolumnar junction .
METHODS	The examiners performing colposcopy and microcolpohysteroscopy were not aware of each other 's interpretation , or of the method of cauterization used .
RESULTS	Follow-up colposcopy was satisfactory in 12 women in group A ( 24 % ) and 47 women in group B ( 92.2 % ) ( P < .001 ) .
RESULTS	Forty-three women ( 86 % ) in group A and ten in group B ( 19.6 % ) had the squamocolumnar junction partly or fully located within the cervical canal ( P < .001 ) .
RESULTS	Microcolpohysteroscopy located the squamocolumnar junction at a mean depth of 4.5 + / - 2.4 mm ( + / - standard deviation [ SD ] ) in the women in group A and 1 + / - 0.9 mm in group B ( P < .001 ) .
RESULTS	Microcolpohysteroscopy could not be performed in 13 women in group A ( 26 % ) and one woman in group B ( 2 % ) ( P < .001 ) .
CONCLUSIONS	Diathermy ball cauterization at the new cervical os after loop excision results in a shift of the squamocolumnar junction toward the endocervical canal , and predisposes to cervical stenosis , thereby decreasing satisfactory colposcopy rates .

###15577832
BACKGROUND	The immunologic response to allergen immunotherapy with 3 serial 5-fold doses of cat extract has been studied after approximately 5 weeks of immunotherapy .
BACKGROUND	The highest dose containing 15 mug of Fel d 1 produced the most consistent and favorable response .
BACKGROUND	It is unknown whether the comparative response on reaching a maintenance dose is maintained with long-term maintenance therapy .
OBJECTIVE	The purpose of this investigation was to evaluate the immunologic responses with these 3 serial doses of cat hair and dander extract at baseline , after reaching the maintenance dose ( approximately 5 weeks ) , and after 1 year of maintenance immunotherapy .
METHODS	Twenty-eight patients with cat allergy randomized in a double-blind study were assigned to one of 4 treatment groups : placebo or cat hair and dander extract containing 0.6 mug of Fel d 1 , 3 mug of Fel d 1 , and 15 mug of Fel d 1 at maintenance .
METHODS	Studies included skin prick tests and late cutaneous reactions with cat hair and dander extract , titrated nasal challenges with the extract , serum cat allergen-specific IgG4 and IgE measurement , and flow cytometric and ELISA analysis of whole blood and intranasal cytokines ( TGF-beta , IL-10 , IFN-gamma , IL-4 , and IL-5 ) .
RESULTS	Twenty-six subjects completed the study .
RESULTS	After both 5 weeks and 1 year , significant and dose-dependent differences were seen with total symptom scores on nasal challenge ( P < .0001 ) , with titrated skin prick testing with cat dander extract at 5 weeks ( P = .014 ) and 1 year ( P < .0001 ) , and with cat-specific IgG4 measurement at 5 weeks ( P = .004 ) and 1 year ( P = .003 ) .
RESULTS	At 1 year , neither flow cytometry of whole blood nor ELISA evaluation of nasal cytokines demonstrated any significant differences among the treatment groups .
CONCLUSIONS	The response to titrated nasal allergen challenge , titrated skin prick testing , and allergen-specific IgG4 measurement to cat immunotherapy at 5 weeks is predictive of the response at 1 year .

###11182878
OBJECTIVE	To evaluate whether a structured community pharmacy-based smoking cessation programme ( the PAS model ) would give rise to a higher smoking cessation rate compared with ad hoc advice from pharmacists .
METHODS	A randomized controlled trial comparing a structured intervention with usual care .
METHODS	One hundred pharmacists working in community pharmacies in N. Ireland and 24 in London took part in the study and were each asked to enroll 12 smokers ; 44 % of pharmacists who were trained managed to recruit one or more smokers during the recruitment period of approximately 1 year .
METHODS	A total of 484 smokers were enrolled by the pharmacists and individually randomized into the PAS intervention group ( N = 265 ) or the control group ( N = 219 ) .
METHODS	The PAS intervention involved a structured counselling programme , an information leaflet and a follow-up weekly for the first 4 weeks then monthly as needed .
METHODS	The primary outcome measure of this study was self-reported smoking cessation for 12 months with cotinine validation at the 12-month follow-up .
RESULTS	Of smokers in the PAS group , 14.3 % ( 38 ) were abstinent up to 12 months compared with 2.7 % ( 6 ) in the control group ( p < 0.001 for the difference ) .
CONCLUSIONS	The community pharmacy-based PAS smoking cessation service can be an effective method of helping people stop smoking when delivered by pharmacists willing to adopt this approach .

###8420877
OBJECTIVE	In previous work we have found that the cumulative minutes of treatment for which 90 % of measured intratumoral temperatures ( T90 ) exceeded 39.5 degrees C was highly associated with complete response of superficial tumors .
OBJECTIVE	Similarly , the cumulative time for which 50 % of intratumoral temperatures ( T50 ) exceeded 41.5 degrees C was highly associated with the presence of > 80 % necrosis in soft tissue sarcomas resected after radiotherapy and hyperthermia .
OBJECTIVE	In the present work we have calculated the time for isoeffective treatments with T90 = 43 degrees C and T50 = 43 degrees C , respectively , using published thermal isoeffective dose formulae .
OBJECTIVE	The purpose of these calculations was to determine the sensitivity of treatment outcome to variations in thermal isoeffective dose .
METHODS	The basis for the calculations were the thermal parameters and treatment outcomes in three patient populations : 44 patients with moderate or high grade soft tissue sarcoma treated preoperatively with hyperthermia and radiation ; 105 patients with superficial tumors treated with hyperthermia and radiation , and 59 patients with deep tumors treated with hyperthermia and radiation .
RESULTS	The thermal dose values calculated are strongly associated with outcome in multivariate logistic regression analysis .
RESULTS	Simple dose-response equations result from the analysis , and we use these equations to assess the sensitivity of outcome upon variations in thermal dose .
RESULTS	This information , in turn , allows us to estimate the number of patients required in Phase II and III trials of hyperthermia and radiation therapy .
CONCLUSIONS	For regimens of 5 to 10 hyperthermia treatments , improvements in median T90 ( superficial tumors ) and T50 ( deep tumors ) parameters by 1.2-1 .5 degrees C could result in response rates high enough ( compared to radiotherapy alone ) to justify Phase III trials .
CONCLUSIONS	A similar improvement in response rates would require an increase in overall duration of treatment by a factor of 3 to 5 .
CONCLUSIONS	This would be difficult to achieve while also avoiding thermal tolerance induction .
CONCLUSIONS	Achieving these temperature goals may be possible with improvements in hyperthermia technology .
CONCLUSIONS	Alternatively , there may be ways to increase the sensitivity of cells to temperatures that can be achieved currently , such as pH reduction or chemosensitization .

###16383040
OBJECTIVE	To explore the bio-inductive effects of inorganic elements ( Dermlin ) on the human epithelial proliferation and differentiation and their promoting effects on skin wound healing .
METHODS	1 ) .
METHODS	Cellular test : Normal human skin epithelial cells were cultured with 20 g/L Dermlin supplemented culture medium ( E group ) and regular culture medium ( C group ) , respectively .
METHODS	The cell proliferation rate and the expressions of type IV collagen and epidermal growth factor ( EGF ) in the supernatant were determined in 12 and 20 post culture days ( PCD ) .
METHODS	( 2 ) .
METHODS	Animal test : Self-consubstantiality control was employed in the study .
METHODS	Sixty Sprague - Dawley rats were inflicted with two symmetric 10 % TBSA of superficial or deep partial thickness scald on the back of each rat , and were divided into control [ C , with topical application of silver sulfadiazine ( SD - Ag ) cream to the wounds ] and treatment ( T , with 1 g/100 cm2 Dermlin topical application to the wounds ) groups .
METHODS	The pathological changes in wound skin were observed and the wound healing rate was calculated on 3 , 5 , 7 , 10 , 14 and 18 post treatment day ( PTD ) .
METHODS	( 3 ) .
METHODS	Randomized , double-blinded and consubstantiality control method was employed in the clinical trial .
METHODS	Ninety patients were enrolled in the clinical study , among them 30 cases with 60 donor site wounds , 30 with 60 superficial and 30 with 60 deep partial thickness burn wounds were included .
METHODS	Dermlin in dose of 1 g/100 cm2 was applied to the wounds in T group and SD - Ag cream in C group for up to 18 days .
METHODS	Furthermore , sixty patients with diabetic foot ulcers were included for 1 g/100 cm2 Dermlin treatment .
METHODS	The wound healing rate was observed .
METHODS	And the blood and urine test and the indices of hepatic and renal function were determined .
RESULTS	1 ) .
RESULTS	Cellular test : The cell proliferation rate and the expression of type IV collagen and EGF in the culture supernatant were obviously higher than those in control group at the same time points ( P < 0.01 ) .
RESULTS	2 ) .
RESULTS	Animal test : Hyperplastic granulation tissue occurred in the rat wound in the T group since 5 PTD , while that occurred in the C group since 7 PTD .
RESULTS	The healing rate of superficial thickness wound in T group on 7 , 10 , 14 PTD , and that of deep partial thickness wound in T group on 5 , 10 , 18 PTD were obviously higher than that in the C group ( P < 0.05 ) .
RESULTS	3 ) .
RESULTS	Clinical study indicated that the wound healing rate of the patients with superficial or deep partial thickness scald in the T group was evidently higher than that in the C group on 5 and 10 PTD ( P < 0.05 ) , but the wound healing time of the superficial , deep partial thickness wound and donor site wound in the T group was significantly shorter than that in the C group ( P < 0.05 ) .
RESULTS	Before treatment , the square of the ulcers on the foot of the patients with diabetic was ( 39 + / - 28 ) cm2 , and it was reduced to ( 19 + / - 23 ) cm2 2 weeks later , with the therapeutic efficacy reaching 62.5 % .
RESULTS	For all patients , no obvious change was found in the blood test and hepatic and renal function indices .
CONCLUSIONS	The inorganic element ( Dermlin ) is beneficial to wound healing and to the proliferation and differentiation of epithelial cells .

###25188501
OBJECTIVE	To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) .
METHODS	Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) .
METHODS	The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score .
METHODS	The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score .
METHODS	Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores .
METHODS	The study took place from October 2012 through August 2013 .
RESULTS	Patients ( N = 340 ; 79 % male , 66 % black ) were randomized to AOM ( n = 168 ) or placebo ( n = 172 ) .
RESULTS	Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P .0005 ) .
RESULTS	LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) .
RESULTS	Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) .
CONCLUSIONS	Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability .
CONCLUSIONS	These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode .
BACKGROUND	ClinicalTrials.gov identifier : NCT01663532 .

###10334140
OBJECTIVE	To compare the systemic bioavailability ( assessed by cortisol suppression ) of high-dose budesonide when given by four inhaler devices and orally .
OBJECTIVE	Also studied are the relative systemic potencies of three inhaled steroids ( budesonide , fluticasone propionate , and beclomethasone dipropionate ) when given by metered-dose inhaler ( MDI ) with a large volume spacer .
METHODS	Double-blind , crossover , placebo-controlled trial .
METHODS	Sixteen healthy , steroid-naive adult volunteers .
METHODS	On separate occasions , each subjects took 4 mg of budesonide through the following devices : MDI alone , MDI with 750-mL .
METHODS	spacer , dry-powder inhaler and nebulizer ; 4 mg of budesonide was also taken orally to assess the effects of GI absorption .
METHODS	For the drug comparison , each subject took 4 mg of budesonide , fluticasone , and beclomethasone , and 2 mg of budesonide and fluticasone by MDI and spacer .
RESULTS	Greatest percent suppression ( 95 % confidence interval ) of 9:00 AM cortisol with budesonide was observed with MDI alone ( 73 % [ 57 to 90 ] ) and turbohaler ( 72 % [ 58 to 86 ] ) compared with MDI spacer ( 42 % [ 22 to 64 ] ) and oral administration ( 14 % [ +6 - to -34 ] ) .
RESULTS	Nebulized budesonide produced an insignificant rise in 9:00 AM cortisol level .
RESULTS	The most suppressive drug ( given by MDI spacer ) was fluticasone at 4 mg ( 86 % [ 82 to 91 ] ) and at 2 mg ( 72 % [ 59 to 85 ] ) .
RESULTS	The least suppressive drug was budesonide at 4 mg ( 43 % [ 22 to 64 ] ) and at 2 mg ( 25 % [ 3 to 47 ] ) .
RESULTS	The effects of 4 mg of beclomethasone were intermediate ( 66 % [ 49 to 82 % ] ) .
CONCLUSIONS	The choice of delivery device for administration of budesonide can lead to important differences in systemic bioavailability .
CONCLUSIONS	Fluticasone has greater systemic potency than budesonide or beclomethasone when given at microgram equivalent dosage .
CONCLUSIONS	The systemic potency ratio of fluticasone propionate to budesonide in normal human volunteers in the present study is similar to the therapeutic potency ratio of the drug in asthmatic patients ( approximately 2:1 ) .

###17999160
BACKGROUND	General and spinal anesthesia are currently in widespread use during transurethral bladder tumor resection .
BACKGROUND	However , local anesthetic methods are claimed to provide sufficient intra-operative analgesia and satisfactory post-operative pain management .
BACKGROUND	We evaluated whether local levobupivacaine infiltration of the tumor would result in outcomes , in terms of intra-operative analgesia , similar to those for utilization of general anesthesia .
BACKGROUND	Post-operative analgesia and patient satisfaction were also assessed .
METHODS	Twenty patients with recurrent solitary bladder tumors were randomly allocated in two groups .
METHODS	Group A , underwent tumor resection under general anesthesia and group B was treated with resection after local levobupivacaine infiltration .
METHODS	Post-operative analgesia was evaluated with utilization of a visual analogue scale , ranging from 0 to 10 , with higher scores indicating more intense pain perception .
RESULTS	Group A patients demonstrated significantly lower visual analogue scale scores at t = 0 , which peaked at 4 h post-operatively .
RESULTS	Group B scores were higher at t = 0 , declined over a 2 h interval and reached zero after t = 4 h. Patients younger than 60 years and women benefitted more .
RESULTS	Local anaesthesia was the method of pain control preferred by 90 % of patients .
CONCLUSIONS	Local levobupivacaine infiltration for transurethral bladder tumor resection seems feasible , providing intra and post-operative pain control .
CONCLUSIONS	In this preliminary setting , general anesthesia provided a higher level of pain control in the immediate post-operative period ( < 4 h ) while local levobupivacaine infiltration demonstrated excellent late post-operative analgesia ( > 4 h ) .
CONCLUSIONS	Also , patients seem to prefer local to general anesthesia in future surgery .

###23081934
METHODS	The aims of this study were to evaluate IgE-mediated hypersensitivity to pine nut with details of clinical reactions and to characterize major pine nut allergens .
RESULTS	The study included ten consecutive teenagers and adults diagnosed with IgE-mediated clinical allergy to pine nut .
RESULTS	Two major pine nut allergens were purified and identified and the secondary structures and susceptibility to digestion were characterized .
RESULTS	Severe reactions represent 80 % of allergic reactions to pine nut in this study .
RESULTS	Moreover , 70 % of the patients were monosensitized to this nut .
RESULTS	Two major allergens with molecular weights of 6 and 50 kDa were purified and identified as albumin and vicilin , respectively .
RESULTS	The 6 kDa protein ( albumin ) , rich in - helix content , was far more stable to peptic and tryptic digestion as compared with 50 kDa protein ( vicilin ) , which was quickly broken down .
RESULTS	The secondary structure of the purified 50 kDa protein showed 41 % - sheet , 5 % - helix , and 54 % random coil and/or loops .
CONCLUSIONS	Eighty percent of allergic reactions to pine nut in the ten patients included in this study were severe .
CONCLUSIONS	Most patients ( 70 % ) were monosensitized to this nut .
CONCLUSIONS	Two major allergens with molecular weights of 6 and 50 kDa were purified and identified as albumin and vicilin , respectively .

###16418021
BACKGROUND	Effective pain relief is important after diagnostic and therapeutic arthroscopic knee surgery to permit early discharge and improve comfort and mobility at home .
BACKGROUND	The aim of this study was to assess the efficacy of bupivacaine , ropivacaine , or a combination of ropivacaine , morphine , and ketorolac injected intra-articularly for postoperative pain relief after arthroscopic knee surgery .
METHODS	Sixty-three healthy patients undergoing knee arthroscopy under local anesthesia ( LA ) were randomized to receive 1 of the following substances intra-articularly postoperatively : group B : 30 mL of bupivacaine ( 150 mg ) ; group R : 30 mL of ropivacaine ( 150 mg ) ; and group RMK : ropivacaine 150 mg , morphine 4 mg , and ketorolac 30 mg in normal saline ( total volume 30 mL ) .
METHODS	Oral paracetamol 1g and tramadol 50 mg were used as rescue drugs .
METHODS	Postoperatively , pain was assessed at rest and movement , and side effects were recorded .
METHODS	The patients were asked to self-assess pain for 7 days and record analgesic consumption as well as activities of daily living ( ADLs ) .
METHODS	Plasma concentration of LA was measured in another 8 patients .
RESULTS	All groups had excellent analgesia at 0 and 4 hours postoperatively .
RESULTS	Group RMK had significantly lower visual analog pain score at rest at 8 hours and during movement at 8 and 24 hours compared with the other groups ( P < .05 ) .
RESULTS	Group RMK required less paracetamol and tramadol on day 1 ( P < .05 ) , had less sleep disturbances because of pain , more patients were ready to work on days 1 and 2 ( P < .05 ) , and were more satisfied on days 1 and 4 to 7 .
RESULTS	Postoperatively , plasma concentrations of ropivacaine and lidocaine were far below known systemic toxic concentrations in all patients .
CONCLUSIONS	Addition of morphine and ketolorac to ropivacaine intra-articularly enhances analgesic efficacy of LA , reduces postdischarge analgesic consumption , and improves ADLs without increasing side effects after ambulatory arthroscopic knee surgery .

###16702494
OBJECTIVE	To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris .
METHODS	A randomized , placebo-controlled trial .
METHODS	International European , multicenter outpatient and inpatient study .
METHODS	Of the 20 enrolled patients , 11 were randomized to the dexamethasone pulse ( DP ) group and 9 to the placebo pulse ( PP ) group .
METHODS	Oral dexamethasone in 300-mg pulses or PPs 3 days per month .
METHODS	During the intervention , the DP and PP groups received conventional treatment with prednisolone , 80 mg/d , which was tapered across 19 weeks , and azathioprine sodium , 3 mg/kg per day , until the end of the study .
METHODS	Monthly pulses were continued until prednisolone treatment was tapered to 0 mg .
METHODS	Number of patients in remission , time to and duration of remission , cumulative prednisolone dose , and occurrence of adverse events during 1 year of follow-up .
RESULTS	Eight of the 11 DP-treated patients and all 9 PP-treated patients achieved remission .
RESULTS	Mean time to remission was 173 days with DP and 176 days with PP .
RESULTS	The mean duration of remission within the first year was 151 days for DP and 141 days for PP .
RESULTS	Mean cumulative prednisolone dose was 5300 mg for DP and 4882 mg for PP .
RESULTS	Weight gain ( > 5 % of baseline ) occurred in 8 DP-treated patients compared with 1 PP-treated patient ( P < .01 ) .
RESULTS	We found no statistically significant difference ( P > .05 ) of an adjuvant effect of DP on remission of pemphigus vulgaris .
CONCLUSIONS	In patients with new pemphigus vulgaris disease activity , there was no benefit of oral DP therapy given in addition to conventional treatment .
BACKGROUND	clinicaltrials.gov Identifier : NCT00127764 .

###19650803
BACKGROUND	In this prospective randomized study , the authors compared the analgesic effect of a fascia iliaca compartment ( FIC ) block with that of intravenous ( i.v. ) alfentanil when administered to facilitate positioning for spinal anaesthesia in elderly patients undergoing surgery for a femoral neck fracture .
METHODS	The 40 patients were randomly assigned to one of two groups , namely , the FIC group ( fascia iliaca compartment block , n = 20 ) and the IVA group ( intravenous analgesia with alfentanil , n = 20 ) .
METHODS	Group IVA patients received a bolus dose of i.v. alfentanil 10 microg/kg , followed by a continuous infusion of alfentanil 0.25 microg/kg/min starting 2 min before the spinal block , and group FIC patients received a FIC block with 30 ml of ropivacaine 3.75 mg/ml ( 112.5 mg ) 20 min before the spinal block .
METHODS	Visual analogue pain scale ( VAS ) scores , time to achieve spinal anaesthesia , quality of patient positioning , and patient acceptance were compared .
RESULTS	VAS scores during positioning ( mean and range ) were lower in the FIC group than in the IVA group [ 2.0 ( 1-4 ) vs. 3.5 ( 2-6 ) , P = 0.001 ] , and the mean ( + / - SD ) time to achieve spinal anaesthesia was shorter in the FIC group ( 6.9 + / - 2.7 min vs. 10.8 + / - 5.6 min ; P = 0.009 ) .
RESULTS	Patient acceptance ( yes/no ) was also better in the FIC group ( 19/1 ) than in the IVA group ( 12/8 ) ( P = 0.008 ) .
CONCLUSIONS	An FIC block is more efficacious than i.v. alfentanil in terms of facilitating the lateral position for spinal anaesthesia in elderly patients undergoing surgery for femoral neck fractures .

###11208681
BACKGROUND	Local cardiac renin-angiotensin systems may regulate left ventricular ( LV ) hypertrophic responses .
BACKGROUND	The absence ( deletion [ D ] ) of a 287-bp marker in the ACE gene is associated with greater myocardial ACE levels and exercise-related LV growth than is its presence ( insertion [ I ] ) , an effect potentially mediated through either increased activity of the cellular growth factor angiotensin II on the angiotensin type 1 ( AT ( 1 ) ) receptor or increased degradation of growth-inhibiting kinins .
BACKGROUND	We sought to confirm ACE genotype-associated exertional LV growth and to clarify the role of the AT ( 1 ) receptor in this association .
RESULTS	One hundred forty-one British Army recruits homozygous for the ACE gene ( 79 DD and 62 II ) were randomized to receive losartan ( 25 mg/d , a subhypotensive dose inhibiting tissue AT ( 1 ) receptors ) or placebo throughout a 10-week physical training program .
RESULTS	LV mass , determined by cardiac magnetic resonance , increased with training ( 8.4 g , P : < 0.0001 overall ; 12.1 versus 4.8 g for DD versus II genotype in the placebo limb , P : = 0.022 ) .
RESULTS	LV growth was similar in the losartan arm : 11.0 versus 3.7 g for DD versus II genotypes ( P : = 0.034 ) .
RESULTS	When indexed to lean body mass , LV growth in the II subjects was abolished , whereas it remained in the DD subjects ( -0.022 versus 0.131 g/kg , respectively ; P : = 0.0009 ) .
CONCLUSIONS	ACE genotype dependence of exercise-induced LV hypertrophy is confirmed .
CONCLUSIONS	Additionally , LV growth in DD ( unlike II ) subjects is in excess of the increase in lean body mass .
CONCLUSIONS	These effects are not influenced by AT ( 1 ) receptor antagonism with the use of losartan ( 25 mg/d ) .
CONCLUSIONS	The 2.4-fold greater LV growth in DD men may be due to the effects of angiotensin II on other receptors ( eg , angiotensin type 4 ) or lower degradation of growth-inhibitory kinins .

###10798461
OBJECTIVE	The purpose of this study was to examine the effects of combining behavioral treatment and drug treatment for urge incontinence in community-dwelling older women .
METHODS	Modified crossover design ( extension of a randomized clinical trial ) .
METHODS	Eligible subjects were stratified according to type and severity of incontinence and randomized to behavioral treatment , drug treatment , or a control condition ( placebo ) .
METHODS	Subjects not totally continent or not satisfied after 8 weeks of a single treatment were offered the opportunity to cross over into combined therapy .
METHODS	A university-based outpatient geriatric medicine clinic .
METHODS	Subjects in the clinical trial were 197 ambulatory , nondemented , community-dwelling women ( age 55 years or older ) with persistent urge urinary incontinence .
METHODS	Thirty-five subjects participated in combined treatment .
METHODS	One group of subjects received four sessions ( over 8 weeks ) of biofeedback-assisted behavioral training followed by 8 weeks of behavioral training combined with drug therapy ( oxybutynin chloride individually titrated from 2.5 mg to 15 mg daily ) .
METHODS	The second group received drug therapy first , followed by 8 weeks of drug therapy combined with behavioral training .
METHODS	Bladder diaries completed by subjects before and after each treatment phase were used to calculate change in the frequency of incontinent episodes .
RESULTS	Eight subjects ( 12.7 % ) crossed from behavioral treatment alone to combined behavioral and drug therapy .
RESULTS	Additional benefit was seen in improvement from a mean 57.5 % reduction of incontinence with single therapy to a mean 88.5 % reduction of incontinence with combined therapy ( P = .034 ) .
RESULTS	Twenty-seven subjects ( 41.5 % ) crossed from drug therapy alone to combined drug and behavioral treatment .
RESULTS	They also showed additional improvement , from a mean 72.7 % reduction of incontinence with single therapy to a mean 84.3 % reduction of incontinence with combined therapy ( P = .001 ) .
CONCLUSIONS	This study shows that combining drug and behavioral therapy in a stepped program can produce added benefit for patients with urge incontinence .

###23725026
BACKGROUND	The objective of this study is to compare histologic and clinical healing following tooth extraction and ridge preservation with either cortical or cancellous freeze-dried bone allograft ( FDBA ) in non-molar extraction sockets .
METHODS	Forty patients requiring implant placement were enrolled , with 20 patients randomly assigned to each group ( cortical versus cancellous FDBA ) .
METHODS	All of the allograft materials were obtained from the same donor to control for variability between donors and processing .
METHODS	Patients returned after 17 to 21 weeks ( average : 18.2 weeks ) , and a 2-mm-diameter core biopsy was obtained before implant placement .
METHODS	Histomorphometric analysis was performed to determine percentage of new bone formation , residual graft material , and non-mineralized connective tissue ( CT ) / other material .
METHODS	Clinical measurements of ridge dimensions were taken at the time of tooth extraction and again at implant placement .
RESULTS	There was no significant difference in new bone formation between the cortical and cancellous FDBA groups ( P = 0.857 ) .
RESULTS	A significantly greater percentage of residual graft material was detected in the cortical FDBA group compared with the cancellous FDBA group ( P = 0.019 ) .
RESULTS	A significantly greater percentage of non-mineralized CT/other material was found in the cancellous FDBA group compared with the cortical FDBA group ( P = 0.040 ) .
RESULTS	The only significant clinical difference between groups was a greater loss of lingual ridge height in the cancellous group .
CONCLUSIONS	This is the first reported study to compare the histologic changes following tooth extraction with ridge preservation in humans using cortical versus cancellous FDBA .
CONCLUSIONS	There were no differences in the percentage of new bone formation between the groups .

###15668596
OBJECTIVE	Nonhormonal treatment of postmenopausal symptoms is a subject of great interest today .
OBJECTIVE	The results of studies on selective serotonin reuptake inhibitors ( SSRIs ) are promising , but long-term results do not exist .
OBJECTIVE	The objective of this study was to evaluate the efficacy of citalopram and fluoxetine in the treatment of physical and psychological menopausal symptoms and their effects on psychosocial and sexual well being in symptomatic postmenopausal women .
METHODS	One hundred fifty healthy women suffering from menopausal symptoms were recruited to this placebo-controlled double-blind study with a follow-up period of 9 months .
METHODS	They were randomized into three groups receiving placebo , fluoxetine , or citalopram .
METHODS	The initial dose was 10 mg of both fluoxetine and citalopram , and it was increased to 20 mg at 1 month and to 30 mg at the 6-month visit .
METHODS	The main outcome measures were hot flushes and Kupperman index .
METHODS	The RAND-36 Quality of Life questionnaire , Beck 's Depression Scale , and the McCoy Female Sexuality Questionnaire were used at every control visit .
RESULTS	There were no statistically significant differences between the groups in respect to number of hot flushes , Kupperman index , or Beck 's Depression Scale , although there was a tendency in all these parameters in favor of SSRIs versus placebo .
RESULTS	Insomnia improved significantly in the citalopram group versus placebo .
RESULTS	Discontinuation rates at nine months were 40 % in the placebo group , 34 % in the fluoxetine group and 34 % in the citalopram group .
CONCLUSIONS	Compared with placebo , citalopram and fluoxetine have little effect on hot flushes and can not therefore be recommended for the treatment of menopausal symptoms , if vasomotor symptoms are the main complaint .
CONCLUSIONS	Whether the improvement of insomnia by means of citalopram affects the quality of sleep needs further investigation .

###23594463
BACKGROUND	Streptococcus pneumoniae is the bacterial agent which most frequently causes pneumonia .
BACKGROUND	In some Scandinavian countries , this infection is treated with penicillin V since the resistances of pneumococci to this antibiotic are low .
BACKGROUND	Four reasons justify the undertaking of this study ; firstly , the cut-off points which determine whether a pneumococcus is susceptible or resistant to penicillin have changed in 2008 and according to some studies published recently the pneumococcal resistances to penicillin in Spain have fallen drastically , with only 0.9 % of the strains being resistant to oral penicillin ( minimum inhibitory concentration > 2g/ml ) ; secondly , there is no correlation between pneumococcal infection by a strain resistant to penicillin and therapeutic failure in pneumonia ; thirdly , the use of narrow-spectrum antibiotics is urgently needed because of the dearth of new antimicrobials and the link observed between consumption of broad-spectrum antibiotics and emergence and spread of antibacterial resistance ; and fourthly , no clinical study comparing amoxicillin and penicillin V in pneumonia in adults has been published .
BACKGROUND	Our aim is to determine whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of uncomplicated community-acquired pneumonia .
METHODS	We will perform a parallel group , randomised , double-blind , trial in primary healthcare centres in Spain .
METHODS	Patients aged 18 to 65 without significant associated comorbidity attending the physician with signs and symptoms of lower respiratory tract infection and radiological confirmation of the diagnosis of pneumonia will be randomly assigned to either penicillin V 1.6 million units thrice-daily during 10days or amoxicillin 1,000 mg thrice-daily during 10days .
METHODS	The main outcome will be clinical cure at 14days , defined as absence of fever , resolution or improvement of cough , improvement of general wellbeing and resolution or reduction of crackles indicating that no other antimicrobial treatment will be necessary .
METHODS	Any clinical result other than the anterior will be considered as treatment failure .
METHODS	A total of 210 patients will be recruited to detect a non-inferiority margin of 15 % between the two treatments with a minimum power of 80 % considering an alpha error of 2.5 % for a unilateral hypothesis and maximum possible losses of 15 % .
CONCLUSIONS	This pragmatic trial addresses the long-standing hypothesis that the administration of high doses of a narrow-spectrum antibiotic ( penicillin V ) in patients with non-severe pneumonia attended in the community is not less effective than high doses of amoxicillin ( treatment currently recommended ) in patients under the age of 65years .
BACKGROUND	EudraCT number 2012-003511-63 .

###20085915
BACKGROUND	In animal models , in vitro culture of preimplantation embryos has been shown to be a risk factor for abnormal fetal outcome , including high and low birthweight .
BACKGROUND	In the human , mean birthweight of singletons after in vitro fertilization ( IVF ) is considerably lower than after natural conception , but it is not known whether culture conditions play a role in this .
METHODS	We compared pregnancy rates and perinatal outcomes from singleton pregnancies resulting from a total of 826 first IVF treatment cycles in which oocytes and embryos were randomly allocated to culture in either of two commercially available sequential media systems .
RESULTS	When the 110 live born singletons in the Vitrolife group were compared with the 78 singletons in the Cook group , birthweight + / - SEM ( 3453 + / - 53 versus 3208 + / - 61 g , P = 0.003 ) , and birthweight adjusted for gestational age and gender ( mean z-score + / - SEM : 0.13 + / - 0.09 versus -0.31 + / - 0.10 , P = 0.001 ) were both significantly higher in the Vitrolife group .
RESULTS	When analyzed by multiple linear regression together with several other variables that could possibly affect birthweight as covariates , the type of culture medium was significantly ( P = 0.01 ) associated with birthweight .
CONCLUSIONS	In vitro culture of human embryos can affect birthweight of live born singletons .

###11914055
BACKGROUND	As a part of the Vadstena Osteoporosis Prevention Project , the knowledge of osteoporosis was examined before the intervention program started , after 5 and 10 years .
METHODS	At baseline ( in 1989 ) 15 % of the population in two Swedish municipalities was randomly invited to the study .
METHODS	The participants in the study group were invited for examination by forearm bone densitometry and a questionnaire concerning lifestyle and risk factors for osteoporosis and also knowledge of osteoporosis , while the subjects in the control group were examined only by questionnaire .
METHODS	Follow-ups were made in 1994 and in 1999 .
METHODS	Meanwhile education about osteoporosis was given to the study group , to the public , and to various professionals in the study community .
RESULTS	There was a difference in the level of knowledge between the groups prior to the intervention .
RESULTS	The rate of increment did not differ significantly between the groups for the study period .
RESULTS	Previous participants had 0.58 higher score than new participants in the study group in 1994 ( P = 0.031 ) and 0.76 higher score in 1999 ( P < 0.001 ) regarding the total number of correct answers .
RESULTS	The women in the study group had 0.63 higher score than the men in 1994 ( P = 0.016 ) and 1.03 higher score in 1999 ( P < 0.001 ) regarding the total number of correct answers .
CONCLUSIONS	There was no significant effect of a general intervention program concerning the knowledge of osteoporosis in participants in the intervention area compared to the control area .

###15125809
OBJECTIVE	Two studies tested ( a ) whether anticipated regret ( AR ) qualifies as an additional predictor of intentions to engage in a health-enhancing behaviour ( exercise ) after variables from the Theory of Planned Behaviour ( TPB ) and past behaviour have been controlled , and ( b ) whether a manipulation that induces participants to focus on AR causes stronger intentions to exercise .
METHODS	Study 1 employed a cross-sectional questionnaire design ; Study 2 employed a between-participants experimental design ( AR focus vs. no AR focus ) .
METHODS	Participants ( N = 385 ) completed standard , multi-item , reliable measures of TPB constructs and AR and also reported their past behaviour ( Study 1 ) .
METHODS	Participants in Study 2 ( N = 70 ) completed measures of AR and intention ; salience of AR was manipulated by means of item order .
RESULTS	Study 1 showed that even though TPB variables and past behaviour were reliable predictors of intention , and explained 51 % of the variance , AR contributed a substantial increment in the variance ( 5 % ) even after these predictors had been taken into account .
RESULTS	Study 2 showed that participants who were induced to focus on AR prior to intention formation had significantly stronger intentions to exercise compared to controls .
CONCLUSIONS	The findings indicate that AR predicts a health-enhancing behaviour ( as well as the health-risk behaviours examined in previous research ) and that effects of AR are independent of TPB variables and past behaviour .
CONCLUSIONS	The findings also indicate that a simple and inexpensive manipulation of the salience of AR can be used to promote exercise intentions .

###22422931
OBJECTIVE	The aim of this study was to determine cardio-respiratory changes after endothoracic sympathetic denervation and their correlation with the extent of denervation .
METHODS	A total of 45 patients with essential palmar hyperhidrosis were randomized into two groups : the conventional group ( CG ; 23 patients ) and the simplified group ( SG ; 22 patients ) .
METHODS	In the CG , excision of T2 and T3 ganglia was performed , whereas in the SG only separation of the sympathetic chain was performed at the same level .
METHODS	Patients underwent respiratory and cardiovascular exercise tests before , at 2 weeks and again at 6 months after the procedure .
METHODS	The postoperative values were then compared with the preoperative values to assess the statistical difference .
RESULTS	Twenty-one patients in each group completed the study .
RESULTS	In the SG , forced expiratory volume in 1 s ( FEV 1 ; P < 0.01 ) and forced vital capacity ( FVC ; P < 0.01 ) were significantly reduced at 2 weeks , but returned to similar baseline values 6 months after the procedure .
RESULTS	No significant cardiac changes were observed .
RESULTS	In the CG , both FEV 1 and FVC were significantly reduced at 2 weeks ( P < 0.01 ) and at 6 months after operation ( P < 0.05 ) .
RESULTS	A significant reduction in forced expiratory flow between 25 and 75 % of vital capacity ( P < 0.01 ) and a relevant increase in airway resistance ( P < 0.05 ) during the entire postoperative course were also observed .
RESULTS	Heart rates at rest and at peak exercise were significantly reduced at 2 weeks ( P < 0.01 ) and significantly decreased 6 months after the procedure ( P < 0.05 ) .
RESULTS	No other changes were registered .
RESULTS	The cardio-respiratory alterations remained at a sub-clinical level ; all patients completed the exercise test without symptoms .
CONCLUSIONS	Sympathectomy may result in a disturbance of bronchomotor tone and cardiac function .
CONCLUSIONS	Such changes remained at a sub-clinical level and seemed directly correlated with the extension of denervation .

###16413334
OBJECTIVE	To evaluate a low-dose abdominal computed tomography ( LDCT ) protocol , delivering a radiation dose close to that delivered by an abdominal plain film ( APF ) , in patients with a clinical suspicion of renal colic .
METHODS	A total of 139 patients for whom an APF was requested for suspicion of renal colic were randomized into two groups .
METHODS	The patients in group 1 ( n = 68 ) underwent an admission LDCT scan delivering a 2.1-mSv radiation dose to women and 1.6 mSv to men , instead of the APF .
METHODS	Patients in group 2 ( n = 71 ) underwent an APF .
METHODS	Clinical and radiologic follow-up data were obtained for each patient .
METHODS	The number of additional abdominal ultrasound and CT scans performed to reach a confident final diagnosis and determine the proper treatment was compared between the two groups .
METHODS	A mean effective radiation dose was obtained in each group .
RESULTS	Of the 68 patients in group 1 ( LDCT ) , 10 ( 15 % ) underwent ultrasonography , 9 ( 13 % ) conventional abdominal CT , and 2 ( 3 % ) both .
RESULTS	In group 2 ( APF ) , the corresponding percentages were 27 % ( 19 of 71 ) , 28 % ( 20 of 71 ) , and 23 % ( 16 of 71 ) .
RESULTS	Of the 68 patients in group 1 , 47 ( 69 % ) did not require any additional examinations compared with 16 ( 23 % ) of the 71 patients in group 2 ( P < 0.0001 ) .
RESULTS	The mean effective dose was 3.5 and 6.9 mSv in groups 1 and 2 , respectively ( P < 0.0001 ) .
CONCLUSIONS	In patients with suspicion of renal colic , replacing the admission APF with our LDCT protocol will significantly reduce the need for additional CT or ultrasonography .
CONCLUSIONS	Also , our LDCT protocol decreases by almost 50 % the mean radiation dose per patient .

###24124121
BACKGROUND	There is evidence that Black patients may experience stereotype threat -- apprehension about being negatively stereotyped -- in healthcare settings , which might adversely affect their behavior in clinical encounters .
BACKGROUND	Recent studies conducted outside of healthcare have shown that a brief self-affirmation intervention , in which individuals are asked to focus on and affirm their valued characteristics and sources of personal pride , can reduce the negative effects of stereotype threat on academic performance and on interpersonal communication .
METHODS	This randomised controlled trial examined whether a self-affirmation ( SA ) intervention would decrease the negative effects of stereotype threat ( negative mood , lower state self-esteem , greater perceptions of racial discrimination ) and increase communication self-efficacy among Black primary care patients .
METHODS	Self-affirmation was induced by having patients complete a 32-item values affirmation questionnaire .
RESULTS	Patients in the SA condition had lower levels of performance self-esteem and social self-esteem than patients in the control .
RESULTS	There were no differences between the SA and the control groups on negative mood , communication self-efficacy , and perceptions of discrimination .
CONCLUSIONS	Our SA intervention lowered state self-esteem among Black patients .
CONCLUSIONS	Future research is needed to determine the type of SA task that is most effective for this population .

###10720274
OBJECTIVE	To investigate whether unilateral pallidotomy affects cognitive and behavioral functioning .
METHODS	At baseline and after 6 months we assessed neuropsychological functioning in 35 patients with advanced PD .
METHODS	After baseline examination , patients were randomized to pallidotomy within 1 month ( 6 left-sided , 13 right-sided ) or to pallidotomy after follow-up assessment 6 months later ( n = 16 ; control group ) .
METHODS	We performed neuropsychological tests of language , visuospatial function , memory , attention , and executive functions .
METHODS	Self ratings and proxy ratings of memory problems and dysexecutive symptoms were also collected .
RESULTS	No significant differences over time were found between pallidotomy and control groups , with the exception of a decrease of verbal fluency in the left-sided pallidotomy group .
CONCLUSIONS	Unilateral pallidotomy is relatively safe with respect to cognition and behavior .
CONCLUSIONS	Left-sided pallidotomy may lead to minor deterioration in verbal fluency .
CONCLUSIONS	The sample size of this study is too small , however , to rule out the possibility of infrequent but clinically important side effects .

###18617314
OBJECTIVE	The effects of the recommended 30:2 compression : ventilation ( C : V ) ratio on chest compression rate ( CR ) , compression depth ( CD ) , compression pressure ( CP ) and rescuer fatigue is unknown during pediatric CPR .
OBJECTIVE	We hypothesized that a 30:2 C : V ratio will decrease compression depth and compression pressure and increase rescuer fatigue compared with a 15:2 ratio .
METHODS	Randomized crossover observational study .
METHODS	Adolescent , child and infant manikins were modified to digitally record compression rate , compression depth , compression pressure and total compression cycles ( CC ) .
METHODS	BLS or PALS certified volunteers were randomized to five CPR groups : adolescent ( AD ) , child 1-hand ( OH ) , child 2-hand ( TH ) , infant two-finger ( TF ) and infant two-thumb ( TT ) .
METHODS	Each rescuer performed each ratio for 5 min with the order randomized .
METHODS	Rescuer heart rate ( HR ) and respiratory rate ( RR ) were recorded continuously during CPR and used to determine the recovery time ( RT ) for HR/RR to return to baseline .
METHODS	Data ( mean + / - S.D. ) were contrasted by paired differences for quantitative data and the sign rank test for ordinal data .
RESULTS	Eighty subjects ( 16 per group ) were randomized .
RESULTS	The peak compression pressure and compression rate were not different within any group , but total compression cycle were higher in all 30:2 groups .
RESULTS	Compression depth ( mm ) was not significantly different within any group .
RESULTS	The rescuer 's HR ( bpm ) increased significantly during 30:2 CPR in AD and OH group with no significant differences in RR and recovery time .
RESULTS	Subjects reported that 15:2 CPR was easier to perform ( P < 0.001 ) .
CONCLUSIONS	During single rescuer pediatric BLS , more compression cycles were achieved with 30:2 C : V ratio without effect on compression depth , pressure and rate .
CONCLUSIONS	Increased HR with 30:2 C : V ratio was noted during larger manikin CPR without subjective difference of reported fatigue .
CONCLUSIONS	Most rescuers in AD and TF group did not achieve recommended compression depth regardless of C : V ratio .

###9862244
OBJECTIVE	To investigate the pharmacokinetic and pharmacodynamic properties of artemether and benflumetol in a fixed combination tablet ( CGP 56697 ) and to offer an explanation for the lower than expected cure rate in a Thai clinical trial .
METHODS	Two hundred and sixty patients were enrolled into a randomized , double-blind , parallel group , dose-finding trial .
METHODS	CGP 56697 was given orally , either as : A , 4 x 4 tablets over 48 h ; B , 4 x 2 tablets over 48 h or C , 3 x 4 tablets over 24 h. Each tablet contained artemether 20 mg amd benflumetol 120 mg .
METHODS	The pharmacokinetics were determined using a population-based approach combining full profiles ( 42 patients ) and sparse data ( 218 patients ) .
METHODS	Parasite clearance time and 28 day cure rate were correlated with the derived pharmacokinetic parameters .
RESULTS	The median absorption half-life of benflumetol was 5.3 h , with a tmax of 10 h and terminal elimination half-life of 4.5 days .
RESULTS	For artemether ( and its metabolite , dihydroartemisinin ) , the corresponding values were 1.9 ( 1.9 ) h , 1.8 ( 1.2 ) h , and 0.84 ( 0.43 ) h.
RESULTS	The variability in bioavailability of artemether and dihydroartemisinin was large both between doses and between patients , but was less pronounced for benflumetol .
RESULTS	Compared with the first dose , benflumetol bioavailability was estimated to increase three-fold by the third and fourth doses .
RESULTS	Higher artemether or dihydroartemisinin AUC was found to decrease parasite clearance time .
RESULTS	Higher benflumetol AUC was found to significantly increase the chance of cure .
CONCLUSIONS	Using a population-based approach it was confirmed that the pharmacokinetic and pharmacodynamic properties of benflumetol and artemether differ markedly .
CONCLUSIONS	Benflumetol AUC is associated with cure and the effect of benflumetol when coadministered with artemether is to prevent recrudescence .
CONCLUSIONS	The mode of action of benflumetol is consistent with its longer elimination half-life .
CONCLUSIONS	A short course of low-dose artemether , which is rapidly absorbed and has a short elimination half-life , produced effective parasite clearance .
CONCLUSIONS	The complementary pharmacokinetic and pharmacodynamic properties of benflumetol and artemether was the main rationale for developing a fixed-dose combination .
CONCLUSIONS	While the 4 x 4 dose regimen is very effective in most endemic areas , the poorer absorption ( 2.5 fold lower than in China ) and the more resistant parasites in Thailand require higher doses of this drug .

###19413933
BACKGROUND	It is important to identify reasons for non-attendance and late cancellations in the health care system to be able to plan possible interventions .
METHODS	Patients with a scheduled visit at the outpatient clinic at the Department of Paediatrics at Kolding Hospital from September 2002 to February 2003 were randomised either to receive or not receive a mailed reminder two weeks prior to their visit .
METHODS	Parents to children cancelling their appointment or not attending were interviewed by telephone to reveal the reasons .
METHODS	>> Early cancellations << were defined as cancellations after receiving the letter and until the last weekday before the appointment , >> late cancellations << as any subsequent cancellations .
RESULTS	A total of 229 and 250 >> early cancellations << of the 2.563 and 2.775 booked appointments were received in the control - and the intervention group , respectively ( p > 0.05 ) .
RESULTS	Only for >> forgot the appointment << , a difference was found between the reasons given .
RESULTS	>> Late cancellation << and non-attendance occurred for 167/1 ,177 and 68/1 ,189 ( p < 0,01 ) of the children .
RESULTS	For 118 and 36 ( p < 0.01 ) of these , the reasons given by the parents could be classified as predictable , and 34/1 ,177 and 27/1 ,189 , respectively as non-predictable ( p = 0.4 ) .
CONCLUSIONS	In the control group more than 70 % of late cancellations and non-attendances could have been predicted by the parents , receiving a mailed reminder reduced this proportion significantly .
CONCLUSIONS	It remains a challenge to reduce the number of non-Danish speaking patients not attending .

###23700057
BACKGROUND	In the ALL-BFM studies for treatment of acute lymphoblastic leukemia , reduction of leukemic blasts in peripheral blood after a one-week prednisone pre-phase - the so-called prednisone response - has been used for risk stratification since the 1980s and has been one of the most relevant factors for identification of high-risk patients .
BACKGROUND	In the trial ALL-BFM 95 , early cytomorphological marrow response on day 15 of induction therapy was prospectively evaluated and its prognostic value was analyzed in comparison to the prednisone response and other established prognostic factors .
RESULTS	Compared to prednisone response , day 15 marrow response was superior in outcome prediction - yet with differential effect depending on blast lineage .
RESULTS	Outcome was poor in T cell leukemia patients with prednisone poor-response independent of day 15 marrow response , whereas among patients with prednisone good-response different risk groups could be identified by day 15 marrow response .
RESULTS	In contrast , prednisone response lost prognostic significance in precursor B cell leukemia when stratified by day 15 marrow response .
CONCLUSIONS	Selective addition of day 15 marrow response to conventional stratification criteria applied on ALL-BFM 95 may significantly improve risk-adapted treatment delivery .
CONCLUSIONS	Even though cutting-edge trial risk stratification is meanwhile dominated by minimal residual disease evaluation , an improved conventional risk assessment , as presented here , could be of great importance to countries lacking the technical and/or financial resources associated with the application of minimal residual disease analysis .

###9625398
BACKGROUND	Garlic powder tablets have been reported to lower serum cholesterol levels .
BACKGROUND	There is widespread belief among the general public that garlic powder tablets aid in controlling cholesterol levels .
BACKGROUND	However , much of the prior data demonstrating the cholesterol-lowering effect of garlic tablets involved studies that were inadequately controlled .
OBJECTIVE	To determine the lipid-lowering effect of garlic powder tablets in patients with hypercholesterolemia .
METHODS	This was a randomized , double-blind , placebo-controlled , 12-week , parallel treatment study carried out in 2 outpatient lipid clinics .
METHODS	Entry into the study after 8 weeks of diet stabilization required a mean low-density lipoprotein cholesterol level on 2 visits of 4.1 mmol/L ( 160 mg/dL ) or lower and a triglyceride level of 4.0 mmol/L ( 350 mg/dL ) or lower .
METHODS	The active treatment arm received tablets containing 300 mg of garlic powder ( Kwai ) 3 times per day , given with meals ( total , 900 mg/d ) .
METHODS	This is equivalent to approximately 2.7 g or approximately 1 clove of fresh garlic per day .
METHODS	The placebo arm received an identical-looking tablet , also given 3 times per day with meals .
METHODS	The main outcome measures included levels of total cholesterol , triglycerides , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol after 12 weeks of treatment .
RESULTS	Twenty-eight patients ( 43 % male ; mean + / - SD age , 58 + / - 14 years ) received garlic powder treatment and 22 ( 68 % male ; mean + / - SD age , 57 + / - 13 years ) received placebo treatment .
RESULTS	There were no significant lipid or lipoprotein changes in either the placebo - or garlic-treated groups and no significant difference between changes in the placebo-treated group compared with changes in the garlic-treated patients .
CONCLUSIONS	Garlic powder ( 900 mg/d ) treatment for 12 weeks was ineffective in lowering cholesterol levels in patients with hypercholesterolemia .

###10632407
OBJECTIVE	To assess the effect of FSH on sperm fertilization potential and sperm intracellular structure in men with oligoteratoasthenozoospermia and a proven low fertilization rate in IVF .
METHODS	Prospective , randomized , partial crossover study .
METHODS	IVF Unit , Golda Campus , Rabin Medical Center , Petah Tikva , Israel .
METHODS	Forty normogonadotropic , normogonadal men with oligoteratoasthenozoospermia and at least one previous IVF attempt in which fertilization failed or the fertilization rate was < 30 % .
METHODS	The men were randomly assigned to treatment with daily injections of 75 IU of FSH or 150 IU of FSH for at least 60 days before IVF treatment .
METHODS	A control group of men underwent an IVF cycle without treatment and then were randomly assigned tojoin group 1A or 1B for an additional IVF cycle with treatment .
METHODS	LH , FSH , and testosterone levels during FSH treatment , evaluation of ultramorphologic changes in sperm by electron microscopy , and comparison of fertilization rates in the control and study groups .
RESULTS	After treatment with 75 IU or 150 IU of FSH , the mean fertilization rates were 19.7 % and 20.5 % , respectively , compared with a 5.8 % fertilization rate in the study control cycles .
CONCLUSIONS	Prolonged treatment with FSH results in a significant increase in fertilization rates .
CONCLUSIONS	This effect may be related to improvements in subcellular components of the sperm .

###22920051
BACKGROUND	The design of new interventions to improve health care for patients with chronic obstructive pulmonary disease ( COPD ) requires knowledge about what patients with an acute exacerbation experience as important and useful .
BACKGROUND	The objective of the study was to explore patients ' experiences of an early discharge hospital at home ( HaH ) treatment programme for exacerbations in COPD .
METHODS	Six exacerbated COPD patients that were randomised to receiving HaH care and three patients randomised to receiving traditional hospital care were interviewed in semi-structured in-depth interviews .
METHODS	Four spouses were present during the respective patients ' interviews .
METHODS	The interviews were audio-taped , transcribed and analysed by a four-step method for systematic text condensing .
RESULTS	Despite limited assistance from the health care service , the patients and their spouses experienced the HaH treatment as safe .
RESULTS	They expressed that information that was adapted to specific situations in their daily lives and given in a familiar environment had positive impact on their self-management of COPD .
CONCLUSIONS	The results contribute to increased knowledge and awareness about what the patients experienced as important aspects of a HaH treatment programme .
CONCLUSIONS	How adapted input from health services can make patients with exacerbation of COPD feel safe and better able to manage their disease , is important knowledge for developing new and effective health services for patients with chronic disease .

###16934269
OBJECTIVE	To compare the effectiveness of oral misoprostol and intravenous oxytocin in reducing blood loss in women undergoing indicated or elective cesarean delivery ( CD ) under spinal anesthesia .
METHODS	In this prospective , double-blind pilot study , 56 parturients who received 5 IU of intravenous oxytocin after cord clamping were randomized to further receive either misoprostol orally and a placebo infusion intravenously or placebo orally and an oxytocin infusion intravenously .
RESULTS	After adjustment was made for the sonographically estimated amniotic fluid volume , there was no statistical difference in blood loss between the 2 groups ( mean + / - S.D. , 1083 + / -920 mL in the oxytocin group vs. 970 + / -560 mL in the misoprostol group ; P = .59 ) .
CONCLUSIONS	Oxytocin followed by oral misoprostol is as effective as an oxytocin injection followed by an oxytocin infusion in reducing postoperative blood loss after CD , and the protocol may be a safe , valuable , and cost-effective alternative to oxytocin alone .
CONCLUSIONS	Visual estimation of intraoperative blood loss undervalues the effective value of misoprostol use by 30 % .

###9798804
BACKGROUND	Ranitidine bismuth citrate ( RBC ) in co-prescription with clarithromycin for 2 weeks has been shown to be effective for the eradication of Helicobacter pylori .
BACKGROUND	Moreover , several studies have reported good H. pylori eradication rates with RBC plus two antibiotics for 1 week .
OBJECTIVE	To compare the H. pylori eradication rates and safety of two different RBC co-prescription regimens .
METHODS	Patients undergoing endoscopy for upper gastrointestinal symptoms were randomized to open treatment with either RBC 400 mg b.d. plus clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 1 week ( RbcCT ) or RBC 400 mg b.d. plus clarithromycin 500 mg b.d. ( RbcC ) for 2 weeks .
METHODS	H. pylori infection was detected by CLO-test on antral biopsy and confirmed by histology on antral and corpus biopsies and by 13C-urea breath test ( UBT ) .
METHODS	A further UBT was performed at least 4 weeks after the end of treatment to assess the H. pylori eradication .
METHODS	H. pylori eradication was calculated for an intention-to-treat ( ITT ) population ( all H. pylori-positive patients who received at least one treatment dose ) and for an all-patients-treated ( APT ) population ( patients of the ITT population assessed for H. pylori at least 4 weeks after the end of treatment ) .
RESULTS	Two hundred and ninety-five patients ( 142 males , 153 females , mean age 48 years ) were recruited to the study .
RESULTS	Of these , 239 had H. pylori infection confirmed by all three tests required by the protocol .
RESULTS	The two treatment groups were similar with respect to all the demographic data .
RESULTS	H. pylori ITT eradication rates were 85 % ( 104/123 ) for RbcCT and 67 % ( 78/116 ) for RbcC .
RESULTS	APT eradication rates were 92 % ( 104/113 ) for RbcCT and 76 % ( 78/103 ) for RbcC .
RESULTS	A significant statistical difference was found between the two treatments , irrespective of the population analysis ( P = 0.001 ) .
RESULTS	Adverse events occurred in 7 % of patients on RbcCT and in 13 % on RbcC .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	The 1-week treatment with RBC plus clarithromycin and tinidazole yielded higher eradication rates than the 2-week treatment with RBC plus clarithomycin .
CONCLUSIONS	Both treatments were well tolerated .

###25588441
OBJECTIVE	To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves .
METHODS	Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates .
METHODS	Primary care regional centre , Queensland , Australia .
METHODS	Consecutive patients presenting to participating general practitioners for a minor skin excision , between 30 June 2012 and 28 March 2013 , were eligible to participate .
METHODS	The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group .
METHODS	Wound infection , assessed at the time of removal of sutures , and other adverse events .
RESULTS	Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups : non-sterile clean boxed gloves ( n = 250 ) or sterile gloves ( n = 243 ) .
RESULTS	Four hundred and seventy-eight patients contributed data for analysis ( 241 non-sterile , 237 sterile gloves ) .
RESULTS	The incidence of infection in the non-sterile gloves group ( 8.7 % ; 95 % CI , 4.9 % -12.6 % ) was significantly non-inferior compared with the incidence in the control group ( 9.3 % ; 95 % CI , 7.4 % -11.1 % ) .
RESULTS	The two-sided 95 % CI for the difference in infection rate ( - 0.6 % ) was - 4.0 % to 2.9 % , and did not reach the predetermined margin of 7 % which had been assumed as the non-inferiority limit .
RESULTS	RESULTS of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses .
RESULTS	There were no important adverse effects .
CONCLUSIONS	Our study suggests that in regard to wound infection , non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice .
BACKGROUND	ACTRN12612000698875 .

###22247489
OBJECTIVE	To evaluate the associations between visual acuity and self-reported visual function ; visual acuity and health-related quality of life ( QoL ) metrics ; a summary measure of self-reported visual function and health-related QoL ; and individual domains of self-reported visual function and health-related QoL in patients with uveitis .
METHODS	Best-corrected visual acuity , vision-related functioning as assessed by the NEI VFQ-25 , and health-related QoL as assessed by the SF-36 and EuroQoL EQ-5D questionnaires were obtained at enrollment in a clinical trial of uveitis treatments .
METHODS	Multivariate regression and Spearman correlations were used to evaluate associations between visual acuity , vision-related function , and health-related QoL .
RESULTS	Among the 255 patients , median visual acuity in the better-seeing eyes was 20/25 , the vision-related function score indicated impairment ( median , 60 ) , and health-related QoL scores were within the normal population range .
RESULTS	Better visual acuity was predictive of higher visual function scores ( P 0.001 ) , a higher SF-36 physical component score , and a higher EQ-5D health utility score ( P < 0.001 ) .
RESULTS	The vision-specific function score was predictive of all general health-related QoL ( P < 0.001 ) .
RESULTS	The correlations between visual function score and general quality of life measures were moderate ( = 0.29-0 .52 ) .
CONCLUSIONS	The vision-related function score correlated positively with visual acuity and moderately positively with general QoL measures .
CONCLUSIONS	Cost-utility analyses relying on changes in generic healthy utility measures will be more likely to detect changes when there are clinically meaningful changes in vision-related function , rather than when there are only changes in visual acuity .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00132691 . )

###23588865
OBJECTIVE	Propofol causes considerable pain upon injection , although different methods and propofol formulations have been used to decrease this pain .
OBJECTIVE	We aimed to investigate the effect of i.v. esmolol pretreatment on propofol injection pain .
METHODS	Ninety ASA I-II patients undergoing elective surgery under general anesthesia were randomly assigned into three groups of thirty each .
METHODS	A 20 G cannula was inserted into the dorsum of the nondependent hand .
METHODS	After venous occlusion for one minute , groups E , L and S were pretreated with 5 mg/ml ( total 2 ml ) esmolol , 40 mg lidocaine and 2 ml saline i.v. respectively .
METHODS	After release of venous occlusion , one fourth of the total propofol dose was administered at a rate of 0.5 ml/sec .
METHODS	During the injection of both pretreatment solution and propofol , patient pain was assessed by using 4 point scale .
METHODS	Heart rate and noninvasive arterial blood pressure values were recorded before induction , just after entubation and five minutes after entubation .
RESULTS	Demographic values were similar among groups .
RESULTS	Incidence of pain on injection of propofol in the control , esmolol and lidocaine groups was 90 % , 33.3 % , 50 % respectively ( p < 0.05 ) .
RESULTS	Heart rate , systolic arterial pressure , and diastolic arterial pressure values were not different between the groups .
CONCLUSIONS	Pretreatment with low dose esmolol i.v. Seems to be effective in attenuating pain during propofol injection .

###18394742
OBJECTIVE	The goal of this study was to determine the benefits of a functional retraining programme ( with or without daily isokinetic reinforcement of the trunk muscles ) in patients with lower-back pain .
METHODS	Two groups of 30 patients took part in the study .
METHODS	The control group ( CG ) underwent a four-week reconditioning program in a day hospital , whereas a second interventional group ( IG ) additionally performed daily isokinetic training of the trunk muscles .
METHODS	Three evaluations were carried out : before hospitalization ( T1 ) , immediately after hospitalization ( T2 ) and three months postrehabilitation ( T3 ) .
RESULTS	We observed an improvement in each parameter after rehabilitation , regardless of the group .
RESULTS	A decrease in the DALLAS scores revealed a reduced impact of lower-back pain on the patients ' lives .
RESULTS	Pain experienced fell by 24 % , analgesic treatment was significantly decreased ( CG : -53 % ; IG : -56 % ) , muscle endurance was improved ( quadriceps : +30 % , abdominal muscles : +20 % , paraspinal muscles : +23 % , quadratus lumborum : +33 % ) and the patients were more supple , as revealed by a decrease in the finger-to-ground distance ( at T1 , CG : 12.9 + / -6.1 cm ; IG : 13.6 + / -5.5 cm at T1 ; CG : 2.2 + / -5.4 cm ; IG : 2.8 + / -5.1 cm at T2 ) .
RESULTS	The sole difference for CG and IG at T2 resulted from an improvement in the performance of the trunk extensor muscles , which was significantly greater in the IG ( CG : +14 % ; IG : +20 % ) .
RESULTS	Three months after rehabilitation , the benefits were still present for the two groups and , indeed , were even greater for certain parameters .
CONCLUSIONS	Regardless of the protocol , the patients improved in both physical and psychological terms and these improvements were maintained over a short period , at least .
CONCLUSIONS	Our results confirmed that one functional recovery programme is not superior to another for patients with lower-back pain .

###26422723
BACKGROUND	In a phase 2 study , the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis .
BACKGROUND	We sought to evaluate the efficacy and safety of secukinumab , an anti-interleukin-17A monoclonal antibody , in such patients .
METHODS	In this double-blind , phase 3 study , 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab ( at a dose of 10 mg per kilogram ) at weeks 0 , 2 , and 4 , followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks , or placebo .
METHODS	Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24 , depending on clinical response .
METHODS	The primary end point was the proportion of patients with an American College of Rheumatology 20 ( ACR20 ) response at week 24 , defined as a 20 % improvement from baseline in the number of tender and swollen joints and at least three other important domains .
RESULTS	ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg ( 50.0 % ) and 75 mg ( 50.5 % ) than in those receiving placebo ( 17.3 % ) ( P < 0.001 for both comparisons with placebo ) .
RESULTS	Secondary end points , including the ACR50 response and joint structural damage , were significantly better in the secukinumab groups than in the placebo group .
RESULTS	Improvements were sustained through 52 weeks .
RESULTS	Infections , including candida , were more common in the secukinumab groups .
RESULTS	Throughout the study ( mean secukinumab exposure , 438.5 days ; mean placebo exposure , 128.5 days ) , four patients in the secukinumab groups had a stroke ( 0.6 per 100 patient-years ; 95 % confidence interval [ CI ] , 0.2 to 1.5 ) , and two had a myocardial infarction ( 0.3 per 100 patient-years ; 95 % CI , 0.0 to 1.0 ) , as compared with no patients in the placebo group .
CONCLUSIONS	Secukinumab was more effective than placebo in patients with psoriatic arthritis , which validates interleukin-17A as a therapeutic target .
CONCLUSIONS	Infections were more common in the secukinumab groups than in the placebo group .
CONCLUSIONS	The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use .
CONCLUSIONS	( Funded by Novartis Pharma ; ClinicalTrials.gov number , NCT01392326 . )

###17875551
OBJECTIVE	To analyse the effects of leflunomide and methotrexate treatment on matrix metalloproteinase ( MMP ) activity levels in alpha2 macroglobulin/MMP ( alpha2M/MMP ) complexes in the systemic circulation of rheumatoid arthritis ( RA ) patients .
METHODS	A total of 102 RA patients from a prospective , double-blind , randomised clinical trial comparing leflunomide and methotrexate were selected ; clinical data and blood samples were collected at baseline , at 4 months and at 1 year .
METHODS	Serum MMP activity levels in alpha2M were quantified using low molecular weight fluorogenic substrates , indicating the proportion of activated MMPs that were not inhibited by specific tissue inhibitors of MMP ( TIMP ) .
RESULTS	Patients had active disease as shown by high disease activity score ( DAS , mean of 6.9 and 7.0 for methotrexate and leflunomide patients respectively ) , which was reduced over the study period ( 4.2 and 5.2 respectively , p < 0.001 ) .
RESULTS	In leflunomide-treated patients a significant reduction of MMP activity levels was observed as early as at the 4 months timepoint persisting thereafter , whereas in methotrexate-treated patients the reduction was seen at 1 year .
CONCLUSIONS	The results show that systemic levels of activated MMPs are reduced in RA patients upon exposure to leflunomide or methotrexate .

###16921039
OBJECTIVE	In patients with newly diagnosed glioblastoma multiforme , to determine whether cisplatin plus carmustine ( BCNU ) administered before and concurrently with radiation therapy ( RT ) improves survival compared with BCNU and RT and whether survival using accelerated RT ( ART ) is equivalent to survival using standard RT ( SRT ) .
METHODS	After surgery , patients were stratified by age , performance score , extent of surgical resection , and histology ( glioblastoma v gliosarcoma ) and then randomly assigned to arm A ( BCNU plus SRT ) , arm B ( BCNU plus ART ) , arm C ( cisplatin plus BCNU plus SRT ) , or arm D ( cisplatin plus BCNU plus ART ) .
RESULTS	Four hundred fifty-one patients were randomly assigned , and 401 were eligible .
RESULTS	Frequent toxicities included myelosuppression , vomiting , sensory neuropathy , and ototoxicity and were worse with cisplatin .
RESULTS	There was no difference in toxicity between SRT and ART .
RESULTS	Median survival times and 2-year survival rates for patients who received BCNU plus RT ( arms A and B ) compared with cisplatin , BCNU , and RT ( arms C and D ) were 10.1 v 11.5 months , respectively , and 11.5 % v 13.7 % , respectively ( P = .19 ) .
RESULTS	Median survival times and 2-year survival rates for patients who received SRT ( arms A and C ) compared with ART ( arms B and D ) were 11.2 v 10.5 months , respectively , and 13.8 % v 11.4 % , respectively ( P = .33 ) .
CONCLUSIONS	Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival .
CONCLUSIONS	SRT and ART produced similar toxicity and survival .

###15025742
OBJECTIVE	Our aim was to investigate the effect of the CYP2C8 inhibitor trimethoprim on the pharmacokinetics and pharmacodynamics of the antidiabetic drug repaglinide , and to examine the influence of the former on the metabolism of the latter in vitro .
METHODS	In a randomized , double-blind , crossover study with two phases , nine healthy volunteers took 160 mg trimethoprim or placebo orally twice daily for 3 days .
METHODS	On day 3 , 1 h after the last dose of trimethoprim or placebo , they ingested a single 0.25 mg dose of repaglinide .
METHODS	Plasma repaglinide and blood glucose concentrations were measured for up to 7 h post-dose .
METHODS	In addition , the effect of trimethoprim on the metabolism of repaglinide by human liver microsomes was investigated .
RESULTS	Trimethoprim raised the AUC ( 0 , infinity ) and C ( max ) of repaglinide by 61 % ( range , 30-117 % ; P = 0.0008 ) and 41 % ( P = 0.005 ) , respectively , and prolonged the t ( ( 1/2 ) ) of repaglinide from 0.9 to 1.1 h ( P = 0.001 ) .
RESULTS	Trimethoprim had no significant effect on the pharmacokinetics of its aromatic amine metabolite ( M1 ) , but decreased the M1 : repaglinide AUC ( 0 , infinity ) ratio by 38 % ( P = 0.0005 ) .
RESULTS	No effect of trimethoprim on the blood glucose-lowering effect of repaglinide was detectable .
RESULTS	In vitro , trimethoprim inhibited the metabolism of ( 220 nm ) repaglinide in a concentration-dependent manner .
CONCLUSIONS	Trimethoprim raised the plasma concentrations of repaglinide probably by inhibiting its CYP2C8-mediated biotransformation .
CONCLUSIONS	Although the interaction did not significantly enhance the effect of repaglinide on blood glucose concentration at the drug doses used , the possibility of an increased risk of hypoglycaemia should be considered during concomitant use of trimethoprim and repaglinide in patients with diabetes .

###25268656
BACKGROUND	Botulinum toxin injections are used to treat spasticity in stroke .
BACKGROUND	Although this treatment is effective on muscle tone , its effect on functional gait-related activities remains uncertain .
OBJECTIVE	The aim of this randomized controlled trial was to determine the effect of a self-rehabilitation programme as an adjunct to botulinum toxin injections on gait-related activities in patients with chronic hemiparesis .
METHODS	Thirty-five outpatients were included .
METHODS	Each patient was randomized to 1 of 2 groups : botulinum toxin + standardized self-rehabilitation programme ( R group , n = 19 ) or botulinum toxin alone ( C group , n = 16 ) .
METHODS	Each patient was evaluated with the following tests before botulinum toxin injections and one month afterwards : 10-m timed walk , Timed Up and Go , distance covered in 6 min over an ecological circuit , and the stair test .
RESULTS	There were significant improvements in the R group compared with the C group : maximal gait speed improved by 8 % ( p = 0.003 ) ; distance covered in 6 min over an ecological circuit increased by 7.1 % ( p = 0.01 ) ; and time to ascend and to descend a flight of stairs decreased by 9.8 % ( p = 0.003 ) and 6.6 % ( p = 0.009 ) , respectively .
RESULTS	The self-rehabilitation programme was well tolerated and safe .
CONCLUSIONS	These results strongly suggest that a standardized self-rehabilitation programme constitutes a useful adjunct to botulinum toxin injections in order to improve gait-related activities .

###15890561
BACKGROUND	PAH trials traditionally use 6MW as the primary endpoint .
BACKGROUND	Concerns regarding a `` ceiling effect '' masking efficacy have led to exclusion of patients with milder disease from most trials ( BL 6MW > 450 m ) .
BACKGROUND	STRIDE I evaluated the selective endothelin A receptor antagonist , sitaxsentan ( SITAX ) , in a 12-week randomized , double-blind , trial ( 178 patients ) employing placebo ( PBO ) , 100 mg or 300 mg SITAX orally once daily in PAH and included patients with NYHA class II , congenital heart disease and a BL 6MW > 450 m , groups often excluded from previous trials .
METHODS	We analyzed 6MW effects For All Pts ( intention-to treat ) and those meeting Traditional enrollment criteria , defined as patients with NYHA class III or IV and 6MW < or = 450 m at BL with idiopathic PAH or PAH related to connective tissue disease .
METHODS	The 100 mg and 300 mg SITAX arms are pooled based on similar treatment effects on 6MW .
CONCLUSIONS	Existence of a `` ceiling effect '' is supported by these data .
CONCLUSIONS	The magnitude of the treatment effect and statistical power when using 6MW as the endpoint .
CONCLUSIONS	Comparisons between PAH trials that do not adjust for the effects of differing enrollment criteria require caution .

###20692562
OBJECTIVE	To compare a transconjunctival single-plane sclerocorneal incision with 2 tiny conjunctival cuts at both ends and a clear corneal incision ( CCI ) in cataract surgery .
METHODS	Department of Ophthalmology , Institute of Clinical Medicine , University of Tsukuba , Ibaraki , Japan .
METHODS	Patients having routine cataract surgery were randomly divided into 2 groups based on incision type ; that is , transconjunctival single-plane sclerocorneal or CCI .
METHODS	The incidence of intraoperative ballooning of the conjunctiva ( chemosis ) and the percentage of eyes that required stromal hydration to securely close the wound in each group were recorded and compared .
RESULTS	Each group comprised 61 eyes ( 61 patients ) .
RESULTS	No eye in the transconjunctival sclerocorneal group and 6 eyes ( 9.8 % ) in the CCI group developed intraoperative conjunctival chemosis ( P = .027 , Fisher exact probability test ) .
RESULTS	Corneal stromal hydration was required in 2 eyes ( 3.3 % ) and 15 eyes ( 24.6 % ) , respectively ( P = .001 ) .
CONCLUSIONS	The transconjunctival single-plane sclerocorneal incision was effective and combined the merits of CCI incisions and sclerocorneal incisions .

###24796463
OBJECTIVE	To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer .
METHODS	It is a prospective , randomized and controlled trial .
METHODS	Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen .
METHODS	The primary endpoint was cardiac safety .
METHODS	The second endpoints were disease-free survival ( DFS ) and overall survival ( OS ) .
RESULTS	One hundred and nine breast cancer patients were enrolled and randomized in this trial .
RESULTS	Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline .
RESULTS	The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction ( LVEF ) .
RESULTS	There was no significant difference between concurrent and sequential groups in cardiac event rates ( 9.1 % vs13 .0 % , P = 0.556 ) , neither of LVEF values at basline or at 3 , 6 , 9 and 12 months during trastuzumab treatment ( P > 0.05 ) .
RESULTS	Four patients ( 7.3 % ) in the concurrent group suffered local recurrences or distant metastases , and 6 participants ( 11.1 % ) in the sequential group had distant metastases .
RESULTS	There was no significant difference between the two groups in DFS ( P = 0.724 ) .
RESULTS	There was no death in both groups .
CONCLUSIONS	Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events .
CONCLUSIONS	Further research is needed to determine the efficacy of this treatment regimen .

###19402296
OBJECTIVE	To determine the effect of vitamin D injection on Serum Magnesium concentration in obese and non obese women .
METHODS	This Interventional study was performed on 82 women ( 17-50 years ) which were randomly selected from general population of Tabriz city .
METHODS	They were assigned into two experimental groups .
METHODS	Obese group with stage 1 and 2 obesity and non obese group with normal weight .
METHODS	Weight was measured to the nearest 0.1 kg using a calibrated Seca scale .
METHODS	Height was measured using a cotton ruler which was pasted on the wall .
METHODS	Body mass index was calculated based on weight and height results .
METHODS	Biochemical parameters were measured before and after injection of 600000 IU doses of vitamin D. Serum Magnesium was measured calorimetrically and Serum 25 hydroxy vitamin D was estimated by Chemiluminescence Immune Assay method ( CLIA ) .
RESULTS	Baseline concentrations of serum Magnesium and 25 hydroxy vitamin D in obese individuals was lower than non obese individuals , the former being significant .
RESULTS	Twenty seven percent of obese women versus 15 % of non obese women were Magnesium deficient .
RESULTS	Vitamin D injection caused a significant increase in serum Magnesium concentration in obese subjects but not in non obese subjects .
RESULTS	There was also a significant increase of serum 25 hydroxy vitamin D in both groups .
RESULTS	Mean elevation in serum Magnesium level among women who had Magnesium deficiency was higher than women with Magnesium adequacy ( P < 0.05 ) .
CONCLUSIONS	Low serum Magnesium concentration in obese individuals can be modified by vitamin D injection .

###23435021
OBJECTIVE	Our objective was to determine whether metabolic syndrome ( MetS ) or its components modified the effect of hormone therapy ( HT ) on the risk of coronary heart disease ( CHD ) events in the Women 's Health Initiative clinical trials .
METHODS	We performed a nested case-control study of incident CHD events during the first 4 years of follow-up in the Women 's Health Initiative HT trials ( estrogen plus progestin therapy [ EPT ] and estrogen therapy [ ET ] ) .
METHODS	There were 359 incident cases of CHD during follow-up .
METHODS	After the exclusion of women with cardiovascular disease ( n = 90 ) , diabetes , or hypertension at baseline ( n = 103 ) , 166 CHD cases were matched to 524 controls on age , randomization date , and hysterectomy status .
METHODS	MetS classification required at least three of five Adult Treatment Panel III criteria .
METHODS	Analyses by and t tests for heterogeneity and logistic regression were performed .
METHODS	Postmenopausal women ( n = 27,347 ) aged 50 to 79 years from 40 US clinical centers participated .
METHODS	Daily conjugated equine estrogens ( 0.625 mg ) and medroxyprogesterone acetate ( 2.5 mg ; EPT ) or conjugated equine estrogens ( 0.625 mg ; ET ) were compared with placebo .
METHODS	The main outcome measure was the odds for CHD with HT use versus placebo by MetS status .
RESULTS	MetS modified the risk of CHD events with HT .
RESULTS	In the pooled analysis , risk was increased with HT versus placebo in women with MetS ( odds ratio , 2.26 ; 95 % CI , 1.26-4 .07 ) , whereas women without MetS were not found to have an increased risk for a CHD event with HT ( odds ratio , 0.97 ; 95 % CI , 0.58-1 .61 ; P for interaction = 0.03 ) .
RESULTS	Results of the EPT and ET trials , when examined separately , were similar .
RESULTS	The constellation of MetS variables was more predictive of risk from HT than MetS components assessed individually .
RESULTS	When women with diabetes or hypertension were included in the analysis , statistically significant effect modification was not detected .
CONCLUSIONS	MetS at baseline in women without prior cardiovascular disease , diabetes , or hypertension at baseline identifies women who are more likely to have had adverse coronary outcomes on HT .
CONCLUSIONS	CHD risk stratification is recommended before initiating HT .
CONCLUSIONS	The basis for the greater risk of CHD events with HT among women with MetS requires further study .

###21991727
OBJECTIVE	In this study , the local anesthetic and post-operative analgesic effects of tramadol were compared to those of lidocaine in minor surgeries under local anesthesia .
METHODS	This double-blind clinical trial study included 70 patients in ASA physical status I and II , aging between 20 and 50 years , undergoing minor surgery ( lipoma excision and revision of scars less than 4 cm within 30 minutes or less ) under local anesthesia .
METHODS	The patients were randomly assigned to receive either 2 mg/kg tramadol ( group T , n = 35 ) or 1 mg/kg lidocaine 2 % ( group L , n = 35 ) subcutaneously .
METHODS	Scores of the pain sensation were recorded as VAS ( visual analogue scale 0-10 ) during injection , incision and 15 , 30 and 45 minutes after incision , and then 2 , 4 and 6 hours post-operatively at the ward .
RESULTS	There was no significant difference between pain scores of the two groups during injection , incision and surgery or in the post-operative period at the ward ( p = 0.181 ) .
RESULTS	Incidence of nausea was 0 % and 22.8 % in group L and group T , respectively .
RESULTS	The difference was statistically significant ( p = 0.002 ) .
RESULTS	Furthermore , 82.9 % of subjects in group L and 60 % of subjects in group T needed acetaminophen to control their pain and the difference was significant ( p = 0.004 ) .
CONCLUSIONS	Tramadol 2 mg/kg has local anesthetic and post-operative analgesic effect equal to lidocaine 1 mg/kg in minor surgeries performed subcutaneously .
CONCLUSIONS	Therefore , we concluded that tramadol can be used as an alternative drug to lidocaine in local anesthesia and has the ability to decrease the demand for post operative analgesics .

###10898421
OBJECTIVE	We tested the hypothesis that different anticoagulant treatments may produce different platelet effects and von Willebrand factor ( vWf ) release in unstable angina .
BACKGROUND	The early increase of vWf has been reported to be a risk factor for adverse outcome in unstable angina .
BACKGROUND	Anticoagulant drugs play a key role in stabilization of unstable angina , but they may not have the same efficacy and the same effects on acute vWf release .
METHODS	We studied 154 patients enrolled in several clinical trials testing four different anticoagulant treatments in unstable angina or non-Q-wave myocardial infarction .
METHODS	Patients were treated during at least 48 h by either intravenous unfractionated heparin , one of two different low molecular weight heparins ( enoxaparin or dalteparin ) or the direct thrombin inhibitor PEG-hirudin .
METHODS	All patients received aspirin but no Ib/IIIa inhibitors .
RESULTS	The release of vWf over the first 48 h ( delta vWf ) did not relate to the baseline clinical characteristics .
RESULTS	At 30 days of follow-up , delta vWf was sevenfold higher in patients with an end point ( death , myocardial infarction , revascularization ) than in patients free of events ( +53 + / -7 % vs. +7 + / -14 % , p = 0.004 ) .
RESULTS	The same trend was present for each component of the composite end point with the highest levels for one-month mortality ( +87 + / - 32 % vs. +26 + / - 8 % , p = 0.09 ) .
RESULTS	The vWf values did not increase over 48 h in patients receiving either enoxaparin or PEG-hirudin ( +10 + / - 9 % and -5 + / - 20 % , respectively ) .
RESULTS	A serious rise ofvWf was measured in unfractionated heparin-treated patients ( +87 + / - 11 % ) , which differed significantly from the enoxaparin group ( p = 0.0006 ) and PEG-hirudin group ( p < 0.0001 ) .
RESULTS	In dalteparin-treated patients , delta vWf was elevated ( +48 + / - 8 % ) and did not differ from the unfractionated heparin group ( NS ) .
CONCLUSIONS	We confirm that , in unstable angina patients , a rise of vWf over the first 48 h is associated with an impaired outcome at 30 days .
CONCLUSIONS	Moreover , the four different anticoagulant treatments tested here do not provide the same protection with regards to vWf release , which may have important prognostic implications and explain different results observed in recent clinical trials .

###20720415
BACKGROUND	Atherosclerosis has long been thought to develop over time in a linear manner from gradual wall thickening to advanced thick lesions .
BACKGROUND	However , evidence has emerged indicating a phasic rather than linear progression with time .
BACKGROUND	A major reason for this non-linear pattern appears to be the occurrence of hemorrhages in the arterial wall , although data on this issue are still scarce .
BACKGROUND	We studied the occurrence of temporarily impressive thickenings of the carotid arterial wall in a cohort of healthy postmenopausal women who were followed up for 3 years with regular carotid ultrasound examinations .
METHODS	The women were the European participants of a randomized placebo-controlled trial into the effect of hormone replacement therapy on progression of carotid intima-media thickness ( CIMT ) .
METHODS	For a period of 3 years , the women underwent a standardized carotid ultrasound protocol every 6 months .
METHODS	Common , bifurcation and internal carotid segments were scanned on both sides , stored on videotape , and the near and far wall CIMT was measured on defined angles and segments , also in areas of plaque .
METHODS	Adverse events were routinely recorded .
METHODS	At the completion of the study , all segment-specific measurements were evaluated for outliers .
METHODS	Images were retrieved from videotape and evaluated whether the outlier resulted from a real morphological change or ` measurement error ' .
RESULTS	The 509 healthy postmenopausal women , free from previous symptomatic cardiovascular disease , underwent 3,812 carotid ultrasound scans during the study , and 44,924 carotid segments were evaluated .
RESULTS	In 203 segments of 188 participants outliers were observed .
RESULTS	True morphological changes were found in 12 participants , equivalent to a 3-year risk of 2.4 % .
RESULTS	These changes did not give rise to clinical symptoms .
RESULTS	In the 6 women of whom we had follow-up measurements , the changes were reversed within 6-12 months .
CONCLUSIONS	We observed acute increases in CIMT among 2.4 % of healthy postmenopausal European women followed for 3 years .
CONCLUSIONS	When assuming these were the result of vessel wall hemorrhages , our findings add to the body of evidence suggesting that vessel wall hemorrhages contribute to atherosclerosis development and also appear to occur clinically silent .

###17637912
OBJECTIVE	RESPIRE , a randomized trial of an improved cookstove , was conducted in Guatemala to assess health effects of long-term reductions in wood smoke exposure .
OBJECTIVE	Given the evidence that ambient particles increase blood pressure , we hypothesized that the intervention would lower blood pressure .
METHODS	TWO STUDY DESIGNS WERE USED : a ) between-group comparisons based on randomized stove assignment , and b ) before-and-after comparisons within subjects before and after they received improved stoves .
METHODS	From 2003 to 2005 , we measured personal fine particle ( particulate matter with aerodynamic diameter < 2.5 microm ; PM ( 2.5 ) ) exposures and systolic ( SBP ) and diastolic blood pressure ( DBP ) among women > 38 years of age from the chimney woodstove intervention group ( 49 subjects ) and traditional open wood fire control group ( 71 subjects ) .
METHODS	Measures were repeated up to three occasions .
RESULTS	Daily average PM ( 2.5 ) exposures were 264 and 102 microg/m ( 3 ) in the control and intervention groups , respectively .
RESULTS	After adjusting for age , body mass index , an asset index , smoking , secondhand tobacco smoke , apparent temperature , season , day of week , time of day , and a random subject intercept , the improved stove intervention was associated with 3.7 mm Hg lower SBP [ 95 % confidence interval ( CI ) , -8.1 to 0.6 ] and 3.0 mm Hg lower DBP ( 95 % CI , -5.7 to -0.4 ) compared with controls .
RESULTS	In the second study design , among 55 control subjects measured both before and after receiving chimney stoves , similar associations were observed .
CONCLUSIONS	The between-group comparisons provide evidence , particularly for DBP , that the chimney stove reduces blood pressure , and the before-and-after comparisons are consistent with this evidence .

###24314839
OBJECTIVE	To describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration ( AMD ) .
METHODS	Prospective cohort study within a randomized clinical trial .
METHODS	Patients with no scar on color fundus photography ( CFP ) or fluorescein angiography ( FA ) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials ( CATT ) .
METHODS	Eyes were assigned to ranibizumab or bevacizumab treatment and to 1 of 3 dosing regimens for 2 years .
METHODS	Masked readers assessed CFP and FA .
METHODS	Baseline demographic characteristics , visual acuity , morphologic features on photography and optical coherence tomography ( OCT ) , and genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios ( aHRs ) and associated 95 % confidence intervals ( CIs ) .
METHODS	Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish whitetissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation .
METHODS	Scar formation .
RESULTS	Scar developed in 480 of 1059 eyes ( 45.3 % ) by 2 years .
RESULTS	Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization ( CNV ) ( aHR , 3.1 ; CI , 2.4-3 .9 ) versus occult CNV , blocked fluorescence ( aHR , 1.4 ; CI , 1.1-1 .8 ) , foveal retinal thickness > 212 m ( aHR , 2.4 ; CI , 1.7-3 .6 ) versus < 120 m , foveal subretinal tissue complex thickness > 275 m ( aHR , 2.4 ; CI , 1.7-3 .6 ) versus 75 m , foveal subretinal fluid ( aHR , 1.5 ; CI , 1.1-2 .0 ) versus no subretinal fluid , and subretinal hyperreflective material ( SHRM ) ( aHR , 1.7 ; CI , 1.3-2 .3 ) versus no SHRM .
RESULTS	Eyes with elevation of the retinal pigment epithelium had lower risk ( aHR , 0.6 ; CI , 0.5-0 .8 ) versus no elevation .
RESULTS	Drug , dosing regimen , and genotype had no statistically significant association with scarring .
RESULTS	Fibrotic scars developed in 24.7 % of eyes , and nonfibrotic scars developed in 20.6 % of eyes .
RESULTS	Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity < 20/40 were more likely to develop fibrotic scars .
CONCLUSIONS	Approximately half of eyes enrolled in CATT developed scar by 2 years .
CONCLUSIONS	Eyes with classic neovascularization , a thicker retina , and more fluid or material under the foveal center of the retina are more likely to develop scar .

###8427238
OBJECTIVE	To examine whether a protein-sparing modified fast diet and a hypocaloric balanced diet are safe and effective for children in an outpatient weight reduction program .
METHODS	Randomization of two groups to either diet , with follow-up at 14.5 months .
METHODS	Physician or parent referral to outpatient program at Children 's Hospital of New Orleans , La. .
METHODS	Nineteen children , ranging in age from 7.5 to 16.9 years , weighing 45 % to 131 % more than the mean weight for age , sex , and height .
METHODS	During the first 10 weeks , 10 children were placed on a protein-sparing modified fast diet ( 2520 to 3360 J ) , and nine children and adolescents were placed on a hypocaloric balanced diet ( 3360 to 4200 J ) .
METHODS	Subsequently , all participants were placed on a hypocaloric diet ; calories were increased from 4200 to 5040 J in a 3-month period and maintained for 1 year .
METHODS	Children were assigned to one of two diets for the first 10 weeks according to their time of enrollment .
RESULTS	Both diets produced significant weight loss during the first 6 months .
RESULTS	However , the protein-sparing modified fast diet produced significantly greater changes in the percentage of overweight at 10 weeks ( -30 % vs -14 % ) and at 6 months ( -32 % vs -18 % ) .
RESULTS	At 10 weeks , a significant loss of adipose tissue with preservation of lean body mass occurred in the protein-sparing modified fast group .
RESULTS	A transient slowing of growth velocity was noted at 6 months in both dietary groups compared with values at 14.5 months .
RESULTS	Growth velocity approached normal levels at 14.5 months compared with standards for North American children .
RESULTS	When dietary groups were combined , the initial mean blood pressure decreased significantly at all points in the study .
RESULTS	The initial mean serum cholesterol value also decreased significantly at 10 weeks .
RESULTS	No biochemical or clinical complications were observed .
CONCLUSIONS	These hypocaloric diets appear to be safe and effective in the short-term management of pediatric obesity .
CONCLUSIONS	However , these diets should not be used without close medical supervision .

###22781186
BACKGROUND	Zingiber officinale R. rhizome ( ginger ) is a popular spice that has traditionally been used to combat the effects of various inflammatory diseases .
BACKGROUND	The aim of this study was to evaluate the effects of ginger on pain relief in primary dysmenorrhea .
METHODS	This was a randomized , controlled trial .
METHODS	The study was based on a sample of one hundred and twenty students with moderate or severe primary dysmenorrhea .
METHODS	The students were all residents of the dormitories of Shahed University .
METHODS	They were randomly assigned into two equal groups , one for ginger and the other for placebo in two different treatment protocols with monthly intervals .
METHODS	The ginger and placebo groups in both protocols received 500mg capsules of ginger root powder or placebo three times a day .
METHODS	In the first protocol ginger and placebo were given two days before the onset of the menstrual period and continued through the first three days of the menstrual period .
METHODS	In the second protocol ginger and placebo were given only for the first three days of the menstrual period .
METHODS	Severity of pain was determined by a verbal multidimensional scoring system and a visual analogue scale .
RESULTS	There was no difference in the baseline characteristics of the two groups ( placebo n = 46 , ginger n = 56 ) .
RESULTS	The results of this study showed that there were significant differences in the severity of pain between ginger and placebo groups for protocol one ( P = 0.015 ) and protocol two ( P = 0.029 ) .
RESULTS	There was also significant difference in duration of pain between the two groups for protocol one ( P = 0.017 ) but not for protocol two ( P = 0.210 ) .
CONCLUSIONS	Treatment of primary dysmenorrhea in students with ginger for 5days had a statistically significant effect on relieving intensity and duration of pain .
BACKGROUND	IRCT201105266206N3 .

###21388309
BACKGROUND	Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease .
BACKGROUND	We investigated whether treatment with an angiotensin-receptor blocker ( ARB ) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria .
METHODS	In a randomized , double-blind , multicenter , controlled trial , we assigned 4447 patients with type 2 diabetes to receive olmesartan ( at a dose of 40 mg once daily ) or placebo for a median of 3.2 years .
METHODS	Additional antihypertensive drugs ( except angiotensin-converting-enzyme inhibitors or ARBs ) were used as needed to lower blood pressure to less than 130/80 mm Hg .
METHODS	The primary outcome was the time to the first onset of microalbuminuria .
METHODS	The times to the onset of renal and cardiovascular events were analyzed as secondary end points .
RESULTS	The target blood pressure ( < 130/80 mm Hg ) was achieved in nearly 80 % of the patients taking olmesartan and 71 % taking placebo ; blood pressure measured in the clinic was lower by 3.1 / 1.9 mm Hg in the olmesartan group than in the placebo group .
RESULTS	Microalbuminuria developed in 8.2 % of the patients in the olmesartan group ( 178 of 2160 patients who could be evaluated ) and 9.8 % in the placebo group ( 210 of 2139 ) ; the time to the onset of microalbuminuria was increased by 23 % with olmesartan ( hazard ratio for onset of microalbuminuria , 0.77 ; 95 % confidence interval , 0.63 to 0.94 ; P = 0.01 ) .
RESULTS	The serum creatinine level doubled in 1 % of the patients in each group .
RESULTS	Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events -- 81 of 2232 patients ( 3.6 % ) as compared with 91 of 2215 patients ( 4.1 % ) ( P = 0.37 ) -- but a greater number had fatal cardiovascular events -- 15 patients ( 0.7 % ) as compared with 3 patients ( 0.1 % ) ( P = 0.01 ) , a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease ( 11 of 564 patients [ 2.0 % ] vs. 1 of 540 [ 0.2 % ] , P = 0.02 ) .
CONCLUSIONS	Olmesartan was associated with a delayed onset of microalbuminuria , even though blood-pressure control in both groups was excellent according to current standards .
CONCLUSIONS	The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern .
CONCLUSIONS	( Funded by Daiichi Sankyo ; ClinicalTrials.gov number , NCT00185159 . )

###21454917
OBJECTIVE	Naltrexone , an efficacious medication for alcohol dependence , does not work for everyone .
OBJECTIVE	Symptoms such as insomnia and mood instability that are most evident during early abstinence might respond better to a different pharmacotherapy .
OBJECTIVE	Gabapentin may reduce these symptoms and help prevent early relapse .
OBJECTIVE	This clinical trial evaluated whether the combination of naltrexone and gabapentin was better than naltrexone alone and/or placebo during the early drinking cessation phase ( first 6 weeks ) , and if so , whether this effect persisted .
METHODS	A total of 150 alcohol-dependent individuals were randomly assigned to a 16-week course of naltrexone alone ( 50 mg/day [ N = 50 ] ) , naltrexone ( 50 mg/day ) with gabapentin ( up to 1,200 mg/day [ N = 50 ] ) added for the first 6 weeks , or double placebo ( N = 50 ) .
METHODS	All participants received medical management .
RESULTS	During the first 6 weeks , the naltrexone-gabapentin group had a longer interval to heavy drinking than the naltrexone-alone group , which had an interval similar to that of the placebo group ; had fewer heavy drinking days than the naltrexone-alone group , which in turn had more than the placebo group ; and had fewer drinks per drinking day than the naltrexone-alone group and the placebo group .
RESULTS	These differences faded over the remaining weeks of the study .
RESULTS	Poor sleep was associated with more drinking in the naltrexone-alone group but not in the naltrexone-gabapentin group , while a history of alcohol withdrawal was associated with better response in the naltrexone-gabapentin group .
CONCLUSIONS	The addition of gabapentin to naltrexone improved drinking outcomes over naltrexone alone during the first 6 weeks after cessation of drinking .
CONCLUSIONS	This effect did not endure after gabapentin was discontinued .

###11798649
OBJECTIVE	To investigate the effect of inhaled nitric oxide ( NO ) combined with helium-oxygen mixture on the pulmonary function of asthmatics .
METHODS	18 asthmatic patients were included in this study .
METHODS	The patients were divided into two groups randomly .
METHODS	One group of patients inhaled 100 ppm NO combined with helium-oxygen mixture , the other group inhaled 40 ppm NO-containing helium-oxygen mixture .
METHODS	Pulmonary function was examined intermittently during the study process and compared with that of the patients treated with salbutamol .
RESULTS	It is shown that inhalation of helium-oxygen mixture improved the forced vital capacity , forced expiratory volume during the first 1.0 second ( FEV ( 1 ) ) , peak expiratory flow rate ( PEFR ) and maximal midexpiratory flow rate ( MMEF ) significantly as compared with inhalation of air .
RESULTS	Although salbutamol inhalation improved FEV ( 1 ) and MMEF , the effect was weaker than helium-oxygen mixture inhalation .
RESULTS	However the effect of helium-oxygen mixture lasted only one minute .
RESULTS	Inhalation of 100 ppm NO with helium-oxygen mixture only slightly improved FEV ( 1 ) and PEFR as compared with inhalation of helium-oxygen mixture .
RESULTS	40 ppm NO with helium-oxygen mixture did not influence the pulmonary function in the asthmatic patient as compared with helium-oxygen mixture alone .
CONCLUSIONS	It is suggested that inhalation of helium-oxygen mixture can improve the pulmonary function of asthmatic patients significantly .
CONCLUSIONS	However , inhalation of NO exerts a weak bronchodilatory effect .

###11742776
OBJECTIVE	To investigate the effect of use of external hip protectors on occurrence of hip fracture .
METHODS	Randomized controlled trial , with randomization at the individual level .
METHODS	residential aged-care facilities in urban areas of New South Wales , Australia .
METHODS	174 women , aged 75 years and older , who had had two or more falls or one fall requiring hospital admission in the previous 3 months , and who lived in hostels or nursing homes .
METHODS	Eighty-six subjects were in the intervention group and 88 in the control group .
METHODS	Use of external hip protectors and encouragement by nurses to use the protectors .
METHODS	Follow-up visits at approximately 2 weeks and 2 , 10 and 18 months to determine falls and fall injury ( including hip fracture ) ; we also measured adherence to hip protector use .
RESULTS	The mean age of participants was 85 ; they lived in 32 different aged-care facilities , two-thirds of which were nursing homes .
RESULTS	Intervention and control groups had similar baseline characteristics , with a mean Barthel index of 58 at enrollment and a mean Short Portable Mental Status Questionnaire score of six errors , indicating severe disability and major cognitive impairment .
RESULTS	During follow-up , a mean of 4.6 falls per person occurred .
RESULTS	There was no difference in mortality , with 28 deaths in each group .
RESULTS	Eight hip fractures occurred in the intervention group and seven in the control group ( hazard ratio 1.46 ; 95 % confidence interval 0.53-4 .51 ) .
RESULTS	No hip fractures occurred when hip protectors were being worn as directed .
RESULTS	Adherence was about 57 % over the duration of the study and hip protectors were worn at the time of 54 % of falls in the intervention group .
RESULTS	Adherence varied markedly between institutions , but the greatest was about 80 % .
CONCLUSIONS	Hip protectors were not effective in reducing the incidence of hip fractures in this study , but because of low statistical power , a reduction in risk of hip fracture of up to 50 % may not have been detected .
CONCLUSIONS	There was limited adherence with their use , resulting in a large number of falls occurring without hip protectors in place .
CONCLUSIONS	All hip fractures in the intervention group occurred when hip protectors were not being used .

###11434650
BACKGROUND	Hypertension in kidney transplant ( KT ) patients may result from attenuated whole-body nitric oxide ( NO ) content and abnormal NO-mediated vasodilation .
BACKGROUND	Increasing NO bioavailability with L-arginine ( ARG ) could theoretically restore the NO-mediated vasodilatory response and lower blood pressure .
METHODS	In a prospective pilot study , 6 normotensive volunteers and 10 KT patients received oral supplements of ARG ( 9.0 g/d ) for 9 days , then 18.0 g/d for 9 more days .
METHODS	Six hemodialysis ( HD ) and 4 peritoneal dialysis patients received the same dose for 14 days .
METHODS	Five KT patients received 30 mL/d of canola oil ( CanO ) in addition to ARG .
METHODS	Systolic ( SBP ) and diastolic ( DBP ) blood pressure , creatinine clearance ( CCr ) , and serum creatinine ( Cr ) were measured at baseline , day 9 , and day 18 .
METHODS	In a subsequent study , 20 hypertensive KT patients with stable but abnormal renal function were randomized in a crossover study to start ARG-only or ARG+C anO supplements for two 2-month periods with an intervening month of no supplementation .
METHODS	SBP , DBP , CCr , and Cr were measured monthly for 7 months .
RESULTS	In the pilot study , ARG reduced the SBP in HD patients from 171.5 + / - 7.5 mmHg ( baseline ) to 142.8 + / - 8.3 mmHg ( p = .028 ) .
RESULTS	In the crossover study , SBP was reduced from baseline ( 155.9 + / - 5.0 mmHg ) , after the first 2 months ( 143.2 + / - 3.2 mmHg ; p = .03 ) and subsequent 2 months ( 143.3 + / - 2.5 mmHg ; p = .014 ) of supplementation .
RESULTS	DBP was also reduced after supplementation in both studies .
RESULTS	CanO had no effect on blood pressure .
RESULTS	Renal function did not change .
CONCLUSIONS	Oral preparations of ARG ( + / - CanO ) were well tolerated for up to 60 consecutive days and had favorable effects on SBP and DBP in hypertensive KT and HD patients .

###22769574
BACKGROUND	The best format of exercise training in patients with chronic heart failure ( CHF ) is controversial .
BACKGROUND	We tested the hypothesis that aerobic continuous training ( ACT ) and aerobic interval training ( AIT ) induce similar effects on functional capacity , central hemodynamics and metabolic profile in patients with postinfarction CHF provided that the training load is equated by an individually-tailored volume/intensity dose of exercise .
METHODS	Twenty patients with postinfarction CHF under optimal medical treatment were randomized to ACT or AIT for 12 weeks .
METHODS	Exercise training consisted in individualized loads prescribed according to the Training Impulses ( TRIMPi ) method , which was determined using the individual HR and lactate profiling obtained during a treadmill test at baseline .
RESULTS	Peak VO2 increased significantly by 22 % with both ACT and AIT , without differences between the two training programs .
RESULTS	Changes in anaerobic threshold and VE/VCO2 slope were not significantly different between ACT and AIT .
RESULTS	Resting HR significantly decreased with both exercise modes .
RESULTS	Resting cardiac output and stroke volume , left ventricular diastolic dimension and ejection fraction did not change from baseline with both exercise modes .
RESULTS	Lipid profile and glucose metabolism were not substantially altered by ACT and AIT .
CONCLUSIONS	ACT and AIT both induce significant improvement in aerobic capacity in patients with postinfarction CHF , without significant differences between the two training modes , provided that patients are trained at the same , individually tailored , dose of exercise .
CONCLUSIONS	The TRIMPi method might represent a step forward in the individualization of an aerobic training tailored to the patient 's clinical and functional status within cardiac rehabilitation programs .

###21321793
BACKGROUND	Asian Americans represent a mix of cultures and immigration experiences , which may put them differentially at risk for mental health problems .
BACKGROUND	Yet , little is known about the mental health needs of older adults from various Asian subgroups compared to non-Hispanic whites .
OBJECTIVE	To compare the prevalence rates of mental distress of Chinese , Filipino , South Asian , Japanese , Korean , and Vietnamese older adults ( aged 55 and older ) to that of non-Hispanic whites ; and to examine subgroup differences in utilization of mental health services .
METHODS	A cross-sectional analysis of a population-based sample of California adults responding to the 2007 California Health Interview Survey .
METHODS	Multivariable logistic regression analysis was used to examine subgroup differences in mental health status and use of mental health services among the six different Asian subgroups and non-Hispanic whites , adjusting for respondents ' demographic and health characteristics , socioeconomic status , and English-language proficiency .
RESULTS	A total of 20,712 respondents were included .
RESULTS	Filipino [ aOR = 2.25 ; 95 % CI = 1.14-4 .47 ] and Korean Americans [ aOR = 2.10 ; 95 % CI = 1.06-4 .17 ] were more likely to report symptoms indicative of mental distress compared to non-Hispanic whites , yet were less likely to have seen a primary care provider [ Filipino : aOR = 0.41 ; 95 % CI = 0.18-0 .90 ; Korean : aOR = 0.24 ; 95 % CI = 0.08-0 .69 ] or have taken a prescription medication [ Filipino : aOR = 0.20 ; 95 % CI = 0.10-0 .40 ; Korean : aOR = 0.15 ; 95 % CI = 0.05-0 .40 ] , even after adjusting for indicators of respondents ' demographic and health characteristics , socioeconomic status , and English-language proficiency .
RESULTS	In contrast , Japanese Americans were less likely to report symptoms indicative of mental distress [ aOR = 0.43 ; 95 % CI = 0.21-0 .90 ] , and were less likely to make use of mental health services compared to non-Hispanic whites .
CONCLUSIONS	The findings from this study not only highlight the unmet mental health needs among older Asian Americans , but also illustrate significant variations among the various Asian subgroups .
CONCLUSIONS	Clinicians who work closely with these patients should regularly screen and assess older Asian adults for symptoms related to their mental health needs .

###26283758
OBJECTIVE	We compared the effect of clopidogrel plus aspirin vs aspirin alone on functional outcome and quality of life in the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial of aspirin-clopidogrel vs aspirin alone after acute minor stroke or TIA .
METHODS	Participants were assessed at 90 days for functional outcome using the modified Rankin Scale ( mRS ) and quality of life using the EuroQol-5 Dimension ( EQ-5D ) .
METHODS	Poor functional outcome was defined as mRS score of 2-6 at 90 days and poor quality of life as EQ-5D index score of 0.5 or less .
RESULTS	Poor functional outcome occurred in 254 patients ( 9.9 % ) in the clopidogrel-aspirin group , as compared with 299 ( 11.6 % ) in the aspirin group ( p = 0.046 ) .
RESULTS	Poor quality of life occurred in 142 ( 5.5 % ) in the clopidogrel-aspirin group and in 175 ( 6.8 % ) in the aspirin group ( p = 0.06 ) .
RESULTS	Disabling stroke at 90 days occurred in 166 ( 6.5 % ) in the clopidogrel-aspirin group and in 219 ( 8.5 % ) in the aspirin group ( p = 0.01 ) .
RESULTS	In stratified analysis by subsequent stroke , there was no difference in 90-day functional outcome and quality of life between the 2 groups .
CONCLUSIONS	In patients with minor stroke or TIA , the combination of clopidogrel and aspirin appears to be superior to aspirin alone in improving the 90-day functional outcome , and this is consistent with a reduction in the rate of disabling stroke in the dual antiplatelet arm .
METHODS	This study provides Class II evidence that for patients with acute minor stroke or TIA , clopidogrel plus aspirin compared to aspirin alone improves 90-day functional outcome ( absolute reduction of poor outcome 1.70 % , 95 % confidence interval 0.03 % -3.42 % ) .

###25828372
BACKGROUND	Results of regular drug-eluting stents ( rDESs ) in bifurcation treatment are not optimal .
BACKGROUND	The aim of the Polish Bifurcation Optimal Stenting I ( POLBOS I ) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert ( Balton , Poland ) .
BACKGROUND	The second aim was to study the effect of final kissing balloon ( FKB ) inflation on clinical outcomes .
METHODS	Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies : BiOSS Expert stent or rDES implantation .
METHODS	Coronary angiography was performed at 12 months .
METHODS	The primary end point was a composite of cardiac-related death , myocardial infarction ( MI ) , and target lesion revascularization ( TLR ) at 12 months .
RESULTS	The BiOSS Expert was implanted in 120 patients ( 49.4 % ) , and an rDES was implanted in 123 patients .
RESULTS	The target vessel was the left anterior descending ( LAD ) artery ( 52 % vs 70 % ) followed by the left main stem ( LMS ) coronary artery ( 22 % vs 15 % ) .
RESULTS	In the rDES group , 38.2 % received paclitaxel-eluting stents .
RESULTS	There were 3 stent implantation failures ( 2 in the rDES group and 1 in the BiOSS Expert group ) .
RESULTS	Side branch treatment with an rDES was required in 10 % of cases in both groups .
RESULTS	At 12 months , the incidence of cumulative major adverse cardiovascular events ( MACE ) was similar in both groups : 13.3 % vs 12.2 % ( P = 0.7 ) .
RESULTS	The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group ( 11.5 % vs 7.3 % ; P = 0.02 ) .
RESULTS	Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert ( 8.1 % vs 13.2 % ; P < 0.05 ) and rDES groups ( 4.9 % vs 9.5 % ; P < 0.05 ) .
CONCLUSIONS	MACE rates were comparable between the 2 groups ; however , the TLR rate was higher in the BiOSS Expert group .
CONCLUSIONS	A more aggressive protocol yielded better angiographic and clinical outcomes .

###24981366
BACKGROUND	Preterm birth is the most important single determinant of adverse outcome in the United Kingdom ; one in every 70 babies ( 1.4 % ) is born before 32weeks ( very preterm ) , yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time .
BACKGROUND	This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation .
BACKGROUND	Optimal timing for clamping the cord remains uncertain , however .
BACKGROUND	The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome , but larger studies reporting substantive outcomes and with long-term follow-up are needed .
BACKGROUND	Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes .
BACKGROUND	This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK .
METHODS	Women are eligible for the trial if they are expected to have a live birth before 32weeks gestation .
METHODS	Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome , triplet or higher order multiple pregnancy , and known major congenital malformation .
METHODS	The interventions will be cord clamping within 20seconds compared with cord clamping after at least two minutes .
METHODS	For births with cord clamping after at least two minutes , initial neonatal care is at the bedside .
METHODS	For the pilot trial , outcomes include measures of recruitment , compliance with the intervention , retention of participants and data quality for the clinical outcomes.Information about the trial is available to women during their antenatal care .
METHODS	Women considered likely to have a very preterm birth are approached for informed consent .
METHODS	Randomisation is close to the time of birth .
METHODS	Follow-up for the women is for one year , and for the children to two years of age ( corrected for gestation at birth ) .
METHODS	The target sample size is 100 to 110 mother-infant pairs recruited over 12months at eight sites .
BACKGROUND	ISRCTN21456601 , registered on 28 February 2013 .

###21780962
OBJECTIVE	This study presents a new comprehensive educational group intervention that offers psycho-education about cognitive aging and contextual factors ( i.e. , negative age stereotypes , beliefs , health , and lifestyle ) , focuses on skills and compensatory behavior , and incorporates group discussion .
OBJECTIVE	Its effects were investigated in community-dwelling older women who report normal age-related cognitive complaints .
METHODS	A randomized controlled trial with an experimental and waiting-list control condition was carried out in a sample of 50 women aged 60-75 years .
METHODS	As the main problem of these individuals were perceived cognitive deficits without actual cognitive decrements , metacognition served as the primary outcome measure .
OBJECTIVE	cognitive functioning and psychological well-being were secondary outcome measures .
OBJECTIVE	A double baseline and a follow-up assessment were carried out .
RESULTS	Participants in the experimental condition reported significantly fewer negative emotional reactions toward cognitive functioning ( U = 164.500 , p = 0.004 ) .
RESULTS	The reported effect size ( = -0.473 ) could be interpreted as large .
CONCLUSIONS	This new comprehensive educational group intervention reduces negative emotional reactions toward cognitive functioning , which seems a prerequisite for improved subjective cognitive functioning and well-being .
CONCLUSIONS	It can potentially contribute the well-being of an important and large group of older adults .

###8905281
OBJECTIVE	Cardiopulmonary bypass induces respiratory dysfunction postoperatively , with activation of both the complement system and white cells implicated .
OBJECTIVE	This study compared the effects of bubble and membrane oxygenators for cardiopulmonary bypass in terms of respiratory dysfunction and markers of white cell activation and endothelial damage .
METHODS	Fifty patients undergoing cardiopulmonary bypass were randomly allocated either membrane or bubble oxygenation .
METHODS	Respiratory function was assessed serially by arterial oxygen tension and alveolar-arterial oxygen gradient .
METHODS	Complement activation was measured by serial sampling of serum C3a levels .
METHODS	White cell activation was assessed by serial measurement granulocyte elastase ; other markers investigated were levels of thromboxane B2 , von Willebrand factor and malondialdehyde .
METHODS	All sample measurements were made preoperatively , early and late during bypass , 4-6 h postoperatively and then on the 1st , 2nd and 6th postoperative day .
METHODS	All samples were corrected for haemodilution , and differences between groups tested non-parametrically .
RESULTS	In both groups of patients there was a highly significant fall ( P < 0.001 ) in arterial oxygen tension accompanied by a highly significant rise ( P < 0.0001 ) in aleveolar-arterial oxygen gradient at 18 h compared to preoperative values persisting until 6 days postoperatively .
RESULTS	Levels of C3a increased significantly in both groups at 10 min post bypass , increased further at 60 min peaking at 4-6 h post bypass .
RESULTS	Granulocyte elastase serum levels increased significantly at 10 min postoperatively in both groups compared to control levels , remaining elevated till 48 h , but returning to control levels by 6 days .
RESULTS	There was a small difference ( P < 0.04 ) between the groups at 4-6 h only .
RESULTS	Levels of von Willebrand factor increased significantly at 60 min post bypass in both groups , remaining elevated 6 days postoperatively .
RESULTS	Levels of malondialdehyde increased at 10 min post bypass , remaining elevated until 6 days post bypass .
RESULTS	Thromboxane levels showed no significant changes .
RESULTS	For all markers measured , there were no significant differences between the groups other than those already indicated .
CONCLUSIONS	This study demonstrated marked respiratory dysfunction , complement activation and white cell activation in patients undergoing cardiopulmonary bypass with either bubble or membrane oxygenators .
CONCLUSIONS	There was marked variability in the response of individual patients with either oxygenation technique , but overall no significant differences between the groups .

###16893526
BACKGROUND	Serotonergic dysregulation is posited to contribute to comorbidity between nicotine dependence and depression .
BACKGROUND	We tested whether acute tryptophan depletion ( ATD ) triggers depressive symptoms in euthymic , unmedicated smokers and nonsmokers with and without history of major depressive disorder ( MDD ) .
METHODS	Acute tryptophan depletion and taste-matched placebo challenges were administered double-blind in counter-balanced order .
METHODS	Participants were four groups of volunteers hypothesized to be of increasing affective vulnerability as follows : nonsmokers lacking recurrent personal and familial history of MDD ( n = 20 ) , smokers lacking recurrent personal and familial history of MDD ( n = 21 ) , nonsmokers with history of recurrent personal and familial MDD ( n = 16 ) , and smokers with recurrent personal and familial history of MDD ( n = 16 ) .
METHODS	Depression , dysphoric mood , and plasma amino acids were measured at baseline and around the time of peak depletion .
RESULTS	Depressive symptom response to ATD was heightened significantly by history of MDD ( p < .001 ) and marginally by smoking ( p = .09 ) .
RESULTS	Smoking seemed to magnify the ATD response of those with a history of MDD ( effect size = .63 ) but had no effect on those without MDD history ( effect size = .06 ) .
CONCLUSIONS	Depressive symptom response to serotonergic challenge is exaggerated in unmedicated , euthymic adults with recurrent personal and familial vulnerability to MDD , perhaps especially if they also smoke .

###1336527
OBJECTIVE	To compare the effects of captopril and atenolol on quality of life of hypertensive patients .
METHODS	In a randomly allocated double-blind crossover trial with two 6-week treatment periods captopril at 25 mg twice a day or atenolol at 50 mg once a day were administered to 265 hypertensive patients ( mean age 56 years ; 55 % men ) .
METHODS	Of these , 65 % were newly treated hypertensives and 35 % were previously uncontrolled on a diuretic alone .
METHODS	A seated diastolic blood pressure of 95-115 mmHg was required after a 3-week placebo run-in period .
METHODS	Any previous diuretic therapy was changed to hydrochlorothiazide ( 25 mg once a day ) and the dose was kept constant throughout the trial .
METHODS	Newly diagnosed patients did not take a diuretic at any time .
METHODS	Quality of life was assessed from self-completed questionnaires measuring psychological well-being , symptomatic side effects of treatment , and activity and perceived well-being ( a health index ) .
METHODS	A relative 's perception of the patients ' mood was also obtained where possible .
RESULTS	Twelve patients withdrew on atenolol and 10 on captopril .
RESULTS	No differences between the drugs were observed in quality of life measures , and 95 % confidence intervals suggested that important differences were excluded .
CONCLUSIONS	We conclude that at the doses used in this trial there were no important differences between captopril and atenolol in their effects on quality of life .

###8993242
BACKGROUND	Acute depletion of plasma fibronectin levels has been reported during and after cardiopulmonary bypass ; degradation of fibronectin by proteolytic enzymes has been suggested as one of the causes .
BACKGROUND	This study was designed to assess the possible preservation of fibronectin levels by aprotinin during cardiopulmonary bypass .
METHODS	Plasma fibronectin levels were evaluated in 19 patients undergoing either elective coronary artery bypass grafting or a valvular heart operation .
METHODS	The study was conducted prospectively in a controlled , randomized , double-blinded manner .
METHODS	Nine test patients ( group A ) received intraoperative , intravenous administration of aprotinin ; 10 control patients ( group B ) received equivalent volume of normal saline solution .
METHODS	Fibronectin levels were measured immediately after induction of anesthesia ( as the baseline for the study ) and at the following times : after 5 minutes on bypass , after 30 minutes on bypass , immediately before the start of rewarming , and after being off bypass for 5 minutes , but before protamine administration .
RESULTS	Both groups ' basic characteristics were very similar .
RESULTS	Group A patients were found to have significantly greater fibronectin levels than group B during and immediately after cardiopulmonary bypass ( p < 0.002 ) .
CONCLUSIONS	Administration of aprotinin intraoperatively appears to result in better preservation of fibronectin levels during cardiopulmonary bypass .
CONCLUSIONS	Although the mechanism of action of aprotinin as a proteolytic inhibitor remains unclear , it has been suggested that it exerts an inhibiting effect on proteolytic enzymes by forming an aprotinin-proteinase complex .
CONCLUSIONS	The clinical implications of the greater level of fibronectin achieved by the intraoperative use of aprotinin during cardiopulmonary bypass need further evaluation .

###7775360
OBJECTIVE	In the treatment of attention-deficit hyperactivity disorder ( ADHD ) , the efficacy of the tricyclic antidepressants and monoamine oxidase inhibitor antidepressants has been compared with that of both placebo and the stimulants ( methylphenidate and/or dextroamphetamine ) .
OBJECTIVE	However , the effectiveness of bupropion has been contrasted only with placebo .
OBJECTIVE	The primary aim of this study was to contrast the efficacy of bupropion with that of methylphenidate in the treatment of ADHD .
METHODS	A double-blind , crossover design was used in this study .
METHODS	After a 14-day medication washout period , 15 ADHD subjects ( 7 to 17 years old ) were randomized to either methylphenidate or bupropion for 6 weeks , washed out for an additional 2 weeks , and then `` crossed over '' to the other drug .
METHODS	Methylphenidate was titrated to the maximum effective dose of 0.4 to 1.3 mg/kg per day ( mean 0.7 mg/kg per day ) and bupropion was titrated to an effective dose ranging from 1.4 to 5.7 mg/kg per day ( mean 3.3 mg/kg per day ) .
RESULTS	Both methylphenidate and bupropion produced significantly greater ( p < .001 ) and equivalent improvement on the Iowa-Conners Teacher 's Rating Scale according to both the subjects ' parents and teachers .
RESULTS	The same pattern of improvement was also noted for improvement on the Clinical Global Impression Scale , Kagan 's Matching Familiar Figures Test , Continuous Performance Test , Children 's Depression Inventory , Children 's Manifest Anxiety Scale , and Rey Auditory-Verbal Learning Test .
CONCLUSIONS	In this double-blind , crossover trial , bupropion and methylphenidate were both effective and did not differ in their overall efficacy as treatments for ADHD .

###12133499
OBJECTIVE	To study the effect of transcranial magnetic stimulation ( TMS ) on the rehabilitation of motor function in patients with cerebral infarction .
METHODS	Two hundred twenty and three patients with the initial attack of cerebral infarction were divided into three groups .
METHODS	( 1 ) One hundred twenty and three patients were randomly further divided into rehabilitation subgroup ( n = 63 , aged 64.0 + / - 7.9 , treated with TMS beginning from the 6 approximately 10 th day after onset ) and control subgroup ( n = 60 , aged 63.5 + / - 7.9 ) .
METHODS	( 2 ) Sixty patients were divided into three subgroups according to the age : 35 approximately 55 ( n = 11 ) , 56 approximately 75 ( n = 20 ) , and over 76 ( n = 30 ) .
METHODS	( 3 ) Forty patients aged 56 approximately 75 were further divided into two subgroups according to the timing of beginning of TMS : subgroup with TMS beginning within 3 months after the initial attack ( n = 20 ) and subgroup with TMS beginning 3 months after the initial attack ( n = 20 ) .
METHODS	Except for TMS , the basic treatment was the same for all of the patients .
METHODS	TMS was given once a day for 14 days .
METHODS	Fugl-Meyer score , Barthel index , and central spinal cord motor conduction time ( CMCT ) were measured twice : just before treatment and after the 14th treatment .
METHODS	A difference less than 20 ms between CMCT values measured before and after TMS and failure to induce CMCT both before and after TMS were regarded as ineffective hess , and a difference more than 20 ms between CMCT values measured before and after TMS and a change from failure to induce CMCT were regarded as effective hess .
RESULTS	The effective rate was 90.5 % in the rehabilitation subgroup and 68.3 % in the control group ( P < 0.05 ) .
RESULTS	The Fugl-Meyer scores were 36.3 + / - 15.8 and 33.7 + / - 13.7 in the rehabilitation subgroup and control subgroup before treatment respectively ( P > 0.05 ) , and were 51.7 + / - 15.7 and 40.0 + / - 13.9 after treatment respectively ( P < 0.01 ) .
RESULTS	The Barthel index were 39.6 + / - 15.8 and 40.0 + / - 14.9 in the two subgroups before treatment respectively ( P > 0.05 ) and were 50.5 + / - 15.7 and 43.9 + / - 15.3 after treatment respectively ( P < 0.05 ) .
RESULTS	The Fugl-Meyer scores before and after TMS were 35.8 + / - 11.3 and 61.6 + / - 18.6 in the subgroup aged 35 approximately 55 ( P < 0.01 ) , 33.5 + / - 14.0 and 49.2 + / - 16.0 in the subgroup aged 56 approximately 75 ( P < 0.001 ) , and 32.1 + / - 10.7 and 37.6 + / - 11.3 in the subgroup aged over 75 ( P > 0.05 ) .
RESULTS	The Fugl-Meyer scores were 41.2 + / - 15.7 and 59.0 + / - 22.8 before and after TCM respectively in the subgroup with early TMS treatment ( P < 0.01 ) , and were 34.3 + / - 13.5 and 45.4 + / - 14.8 respectively in the subgroup with TMS beginning 3 months after the onset ( P < 0.05 ) .
CONCLUSIONS	TMS is effective on the rehabilitation of motor function in patients with cerebral infarction .
CONCLUSIONS	The effectiveness of TMS treatment depends on the age of the patients and timing of beginning treatment .

###23571642
OBJECTIVE	To evaluate the effectiveness of multidisciplinary foot-care , and to evaluate the methodological considerations of a trial of multidisciplinary care in juvenile idiopathic arthritis .
METHODS	Exploratory randomised controlled trial .
METHODS	Children/adolescents with juvenile idio-pathic arthritis and inflammatory joint disease affecting the foot/ankle .
METHODS	Standard medical care was compared with a 12 month program of multidisciplinary foot-care informed by musculoskeletal ultrasound .
METHODS	This program was centred on strict disease control through rigorous examination and interventions delivered by a team comprised of a paediatric rheumatologist , podiatrist , physiotherapist and musculoskeletal ultrasonographer .
METHODS	Patients were assessed on foot impairment and disability scores using the Juvenile Arthritis Foot Disability Index .
RESULTS	Forty-four participants , aged 3-17 years were randomly assigned to receive the experimental ( n = 21 ) or usual care ( n = 23 ) interventions .
RESULTS	There was an overall improvement in levels of foot related impairments in both groups over 12 months .
RESULTS	Between-group differences in change scores for the Juvenile Arthritis Foot Disability Index were not statistically significant at 6 or 12 month follow-ups .
CONCLUSIONS	The integrated multidisciplinary foot care interventions described in this trial were safe , but did not improve foot impairment levels relative to usual care .
CONCLUSIONS	This trial identified several methodological challenges including recruitment/retention , difficulties with outcome tools and potential confounders .

###10784385
BACKGROUND	Plant fats and oils are major sources of mono - and polyunsaturated fatty acids as well as vitamin E , the major fat-soluble antioxidants in human nutrition .
BACKGROUND	Dietary antioxidants are expected to reduce cancer risk by minimizing DNA damage .
OBJECTIVE	To compare the effects of gamma-tocopherol rich corn oil and the mixture of the alpha-tocopherol rich olive/sunflower oil on plasma concentration of tocopherols and on the frequency of sister chromatid exchange ( SCE ) , an indicator of DNA damage .
METHODS	This study had a double-blind , cross-over design and was conducted in 20 normal healthy non-smoking males aged 19-31 years .
METHODS	Design included a 2-week adjustment period and two 2-week test periods in which diets containing 30 % energy as fat including either 80 g of corn oil ( CO ) ( 20 mg alpha-tocopherol , 100 mg gamma-tocopherol ) or 80 g of olive / sunflower oil ( OSO ) ( 24 mg alpha-tocopherol , 2.4 mg gamma-tocopherol ) , as the main fat-source , were given .
METHODS	Blood samples for analysis of SCE rate and content of tocopherols were collected at the beginning ( T0 ) , after adjustment ( T1 ) and after the test period ( T2 ) in intervals of 2 weeks .
RESULTS	After two weeks of the corn oil diet , the plasma concentration of gamma-tocopherol increased but alpha-tocopherol decreased significantly compared to the olive/sunflower oil diet .
RESULTS	The concentration of alpha-tocopherol increased ( CO : 22.99 + / - 1.11 vs. OSO : 24.40 + / - 1.49 micromol/l ) and that of gamma-tocopherol decreased ( CO : 4.19 + / - 0.29 vs. OSO : 2.99 + / - 0.25 micromol/l ) after the olive/sunflower oil diet .
RESULTS	Intake of the corn oil diet was associated with reduced SCE rate and intensity , whereas there was no change in SCE after the olive/sunflower oil diet ( CO : 7.66 + / - 0.25 vs. OSO : 8.06 + / - 0.47 mean SCE/cell )
CONCLUSIONS	The combination of gamma-tocopherol with alpha-tocopherol in corn oil diet despite the lower alpha-tocopherol equivalents/diene acid equivalents ratio achieved better protection against DNA damage than alpha-tocopherol alone in the olive/sunflower oil diet .

###17686453
OBJECTIVE	This in situ blind crossover study investigated the effect of calcium ( Ca ) rinse prior to the use fluoride ( F ) dentifrice on remineralisation of artificially demineralised enamel and on the composition of biofilm .
METHODS	During four phases of 14 days , 10 volunteers wore appliances containing two artificially demineralised bovine enamel blocks .
METHODS	Three times a day , they rinsed with 10 mL of Ca ( 150 mM ) or placebo rinse ( 1 min ) .
METHODS	A slurry ( 1:3 , w/v ) of F ( 1030 ppm ) or placebo dentifrice was dripped onto the blocks .
METHODS	During 1 min , the volunteers brushed their teeth with the respective dentifrice .
METHODS	The appliance was replaced into the mouth and the volunteers rinsed with water .
METHODS	The biofilm formed on the blocks was analysed for F and Ca .
METHODS	Enamel alterations were evaluated by the percentage of surface microhardness change ( % SMHC ) , cross-sectional microhardness ( % mineral volume ) and alkali-soluble F analysis .
METHODS	Data were analysed by ANOVA ( p < 0.05 ) .
RESULTS	The use of the Ca pre-rinse before the F dentifrice produced a six - and four-fold increase in biofilm F and Ca concentrations , respectively .
RESULTS	For enamel , the remineralisation was significantly improved by the Ca pre-rinse when compared to the other treatments .
RESULTS	There was a significantly higher concentration of alkali-soluble F in enamel when the F dentifrice was used , but the Ca pre-rinse did not have any significant additive effect .
CONCLUSIONS	According to our protocol , the Ca pre-rinse significantly increased biofilm F concentration and , regardless the use of F dentifrice , significantly enhanced the remineralisation of artificially demineralised enamel .

###7880510
OBJECTIVE	To evaluate and compare the efficacy of various pretreatment agents to attenuate or prevent opioid-induced muscle rigidity using a well-established , previously described clinical protocol .
METHODS	Prospective , controlled , single-blind , partially randomized study .
METHODS	Large medical center .
METHODS	ASA physical status I-III patients undergoing elective surgical procedures of at least 3 hours ' duration .
METHODS	The effect of pretreatment with nondepolarizing muscle relaxants ( atracurium 40 micrograms/kg or metocurine 50 micrograms/kg ) , benzodiazepine agonists ( diazepam 5 mg or midazolam 2.5 mg ) , or thiopental sodium 1 mg/kg on the increased muscle tone produced by alfentanil 175 micrograms/kg was compared with a control group ( given no pretreatment ) .
RESULTS	Rigidity was assessed quantitatively by measuring the electromyographic activity of five muscle groups ( biceps , intercostals , abdominals , quadriceps , and gastrocnemius ) .
RESULTS	Rigidity also was rated qualitatively by attempts to initiate and maintain mask ventilation , attempts to flex an extremity , and the occurrence of myoclonic movements .
RESULTS	Pretreatment with the two nondepolarizing muscle relaxants had no effect on the severe muscle rigidity produced by high-dose alfentanil .
RESULTS	Whereas thiopental was only mildly effective , the benzodiazepines midazolam and diazepam significantly attenuated alfentanil rigidity ( p < 0.05 ) .
CONCLUSIONS	This study suggests that benzodiazepine pretreatment is frequently , but not always , effective in preventing opioid-induced muscle rigidity .

###23940461
BACKGROUND	Viral load ( VL ) is recommended for monitoring the response to highly active antiretroviral therapy ( HAART ) but is not routinely available in most low - and middle-income countries .
BACKGROUND	The purpose of the study was to determine whether a CD4-based monitoring and switching strategy would provide a similar clinical outcome compared to the standard VL-based strategy in Thailand .
RESULTS	The Programs for HIV Prevention and Treatment ( PHPT-3 ) non-inferiority randomized clinical trial compared a treatment switching strategy based on CD4-only ( CD4 ) monitoring versus viral-load ( VL ) .
RESULTS	Consenting participants were antiretroviral-nave HIV-infected adults ( CD4 count 50-250 / mm ( 3 ) ) initiating non-nucleotide reverse transcriptase inhibitor ( NNRTI ) - based therapy .
RESULTS	Randomization , stratified by site ( 21 public hospitals ) , was performed centrally after enrollment .
RESULTS	Clinicians were unaware of the VL values of patients randomized to the CD4 arm .
RESULTS	Participants switched to second-line combination with confirmed CD4 decline > 30 % from peak ( within 200 cells from baseline ) in the CD4 arm , or confirmed VL > 400 copies/ml in the VL arm .
RESULTS	Primary endpoint was clinical failure at 3 years , defined as death , new AIDS-defining event , or CD4 < 50 cells/mm ( 3 ) .
RESULTS	The 3-year Kaplan-Meier cumulative risks of clinical failure were compared for non-inferiority with a margin of 7.4 % .
RESULTS	In the intent to treat analysis , data were censored at the date of death or at last visit .
RESULTS	The secondary endpoints were difference in future-drug-option ( FDO ) score , a measure of resistance profiles , virologic and immunologic responses , and the safety and tolerance of HAART .
RESULTS	716 participants were randomized , 356 to VL monitoring and 360 to CD4 monitoring .
RESULTS	At 3 years , 319 participants ( 90 % ) in VL and 326 ( 91 % ) in CD4 were alive and on follow-up .
RESULTS	The cumulative risk of clinical failure was 8.0 % ( 95 % CI 5.6-11 .4 ) in VL versus 7.4 % ( 5.1-10 .7 ) in CD4 , and the upper-limit of the one-sided 95 % CI of the difference was 3.4 % , meeting the pre-determined non-inferiority criterion .
RESULTS	Probability of switch for study criteria was 5.2 % ( 3.2-8 .4 ) in VL versus 7.5 % ( 5.0-11 .1 ) in CD4 ( p = 0.097 ) .
RESULTS	Median time from treatment initiation to switch was 11.7 months ( 7.7-19 .4 ) in VL and 24.7 months ( 15.9-35 .0 ) in CD4 ( p = 0.001 ) .
RESULTS	The median duration of viremia > 400 copies/ml at switch was 7.2 months ( 5.8-8 .0 ) in VL versus 15.8 months ( 8.5-20 .4 ) in CD4 ( p = 0.002 ) .
RESULTS	FDO scores were not significantly different at time of switch .
RESULTS	No adverse events related to the monitoring strategy were reported .
CONCLUSIONS	The 3-year rates of clinical failure and loss of treatment options did not differ between strategies although the longer-term consequences of CD4 monitoring would need to be investigated .
CONCLUSIONS	These results provide reassurance to treatment programs currently based on CD4 monitoring as VL measurement becomes more affordable and feasible in resource-limited settings .
BACKGROUND	ClinicalTrials.govNCT00162682 Please see later in the article for the Editors ' Summary .

###21094951
OBJECTIVE	To compare oral ibuprofen with intravenous ibuprofen for closure of patent ductus arteriosus in very low birth weight ( VLBW ) preterm infants .
METHODS	In a prospective , randomized study , 102 VLBW preterm infants with patent ductus arteriosus received either intravenous or oral ibuprofen at an initial dose of 10 mg/kg , followed by 5 mg/kg at 24 and 48 hours .
METHODS	The success rate and evaluation of renal tolerance using cystatin-C were the major outcomes .
RESULTS	Patent ductus arteriosus closure rate was significantly higher with oral ibuprofen ( 84.6 % versus 62 % ) after the first course of the treatment ( P = .011 ) .
RESULTS	The cystatin-C level increased significantly after treatment in the oral group ( P = .001 ) , but did not change with intravenous ibuprofen ( P = .4 ) .
CONCLUSIONS	Oral ibuprofen is more effective than intravenous ibuprofen for ductal closure in VLBW infants .
CONCLUSIONS	The increase in the cystatin-C level with oral treatment suggests that patients with borderline renal function should be evaluated and followed closely .

###19092106
BACKGROUND	Cognitive dysfunction is very common in multiple sclerosis ( MS ) and it severely impairs patients ' quality of life .
BACKGROUND	Thus , we explored whether memantine might improve cognitive performance in patients with MS.
METHODS	We conducted a pilot trial with memantine ( 30 mg/day ) in patients with MS with cognitive impairment .
METHODS	The trial was designed as a 1-year , randomized , double-blind , crossover study comparing memantine against a placebo in 60 patients with MS and cognitive impairment .
METHODS	Cognitive impairment was defined as the performance 1.5 standard deviations below the normative data in at least two tests of two cognitive domains in the Brief Repeatable Battery-Neuropsychology .
METHODS	The primary endpoint was improvement of verbal memory and the secondary endpoints were safety and improvements in the other cognitive domains , disability and quality of life .
METHODS	The trial was registered at www.clinicaltrials.org : NCT00638833 .
RESULTS	Although 19 patients had been included , the trial was halted after nine patients reported a worsening of their neurologic symptoms that deteriorated their quality of life .
RESULTS	Seven of the nine patients in the memantine arm had blurred vision , fatigue , severe headache , increased muscle weakness , walking difficulties , or unstable gait .
RESULTS	Only two patients in the placebo group reported neurologic symptoms and in both cases they were related with changes in their disease-modifying therapy .
RESULTS	The adverse events only occurred on reaching the maximum dose ( 30 mg/day ) .
RESULTS	After stopping medication , the patients reverted to their baseline disability within a few days .
CONCLUSIONS	Memantine at a dose of 30 mg/day may induce transient worsening of neurologic symptoms of multiple sclerosis .

###20964565
BACKGROUND	Topical spironolactone may be effective for the treatment of acne patients with increased sebum secretion .
OBJECTIVE	To evaluate the efficacy of 5 % spironolactone gel in the treatment of mild to moderate acne vulgaris .
METHODS	This study was a double-blind clinical trial , performed randomly in two demographically equivalent groups .
METHODS	In this study , 78 patients with mild to moderate acne vulgaris participated .
METHODS	The patients , as groups of cases ( 38 patients ) and controls ( 40 patients ) , took 5 % spironolactone gel and placebo , respectively .
METHODS	The response to treatment was evaluated by the total acne lesions ( TLC ) and acne severity index ( ASI ) .
RESULTS	The mean age of the case patients was 21.5 4.2 years and of the control patients was 22.2 4.06 years .
RESULTS	The difference in TLC was statistically significant between the two groups ( p = 0.007 ) , but no statistically significant difference was seen between the two groups for ASI ( p = 0.052 ) .
CONCLUSIONS	The 5 % spironolactone topical gel resulted in a decrease in the TLC in acne vulgaris , while it had no significant efficacy in the ASI .

###12031754
OBJECTIVE	To compare the ability of midazolam to produce sedation and anxiolysis and attenuate memory in 100 patients aged 20 to 70 years .
OBJECTIVE	The effect of a point mutation ( Pro385Ser ) for the gamma amino-butyric acid ( GABA ) alpha6 receptor on the sedative , anxiolytic , and memory effects of midazolam was determined .
METHODS	University hospital .
METHODS	Prospective , randomized , double-blind study .
METHODS	100 ASA physical status I and II patients scheduled for surgery .
METHODS	Two midazolam dose groups , 20 microg/kg and 40 microg/kg , with 40 patients per group and 20 control patients receiving saline as a sham control .
METHODS	Treatments were randomly assigned .
METHODS	Blood was collected at the beginning of each study .
METHODS	Patient sedation and anxiolysis were measured using a visual analog scale and explicit and implicit memory of a word task determined before and six minutes after midazolam or saline .
METHODS	A 365-base pair fragment of the GABA alpha6 receptor gene was amplified by polymerase chain reaction ( PCR ) from patient blood DNA and digested with the restrictase Fok I. Restriction fragments were visualized by ethidium bromide staining after electrophoresis to evaluate the GABA alpha6 receptor subunit mutation .
RESULTS	Midazolam produced dose-related sedation and anxiolysis .
RESULTS	Explicit ( recall ) memory was attenuated with high-dose midazolam but implicit ( recognition ) memory remained intact .
RESULTS	The GABA alpha6 receptor mutation did not affect baseline sedation , anxiety , or memory but significantly attenuated the anxiolytic effect of low-dose midazolam .
RESULTS	Sedation and explicit memory were not affected by the mutation .
CONCLUSIONS	A Pro385Ser mutation of the GABA alpha6 receptor subunit decreased the anxiolytic effect of low-dose midazolam .

###25345354
BACKGROUND	As no human data exist , we aimed to determine the relation between ambient temperature and volume of perihematomal ` cerebral ' edema in acute spontaneous intracerebral haemorrhage ( ICH ) among Chinese participants of the pilot phase , Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial ( INTERACT1 ) .
METHODS	INTERACT1 was a multicenter , open , blind outcome assessed , randomized controlled trial of intensive ( systolic target < 140mmHg ) vs. guideline-recommended ( systolic target < 180mmHg ) blood pressure ( BP ) lowering in 404 patients with acute ICH .
METHODS	Data on ambient temperature ( mean , minimum , maximum , and range ) on the day of each participant 's ICH obtained from China Meteorological Data Sharing Service System were linked to other data including edema volumes .
METHODS	Multivariable regression analyses were performed to evaluate association between ambient temperature and edema volumes .
METHODS	A generalized linear regression model with a generalized estimating equations approach ( GEE ) was used to assess any association of ambient temperature and change in edema volume over 72h .
RESULTS	A total of 250 of all 384 Chinese participants had complete data that showed positive associations between ambient temperature ( mean and minimum temperatures ) and edema volumes at each time point over 72h after hospital admission ( all P < 005 ) .
RESULTS	All temperature parameters except diurnal temperature range were positively associated with edema volume after adjustment for confounding variables ( all P < 002 ) .
CONCLUSIONS	An apparent positive association exists between ambient temperature and perihematomal edema volume in acute spontaneous ICH .

###9259053
OBJECTIVE	To determine if adenosine receptor antagonism has any beneficial impact on victims of asystolic cardiac arrest and whether or not it warrants further clinical study as a treatment for cardiac asystole .
METHODS	A 6-month prospective , randomized , double-blinded , placebo-controlled trial , set in an urban emergency medical services system , in adults with nontraumatic asystolic out-of-hospital cardiac arrest .
METHODS	Patients in whom standard advanced cardiac life support pharmacotherapy failed were randomized to receive placebo or aminophylline , a nonspecific competitive adenosine receptor antagonist .
METHODS	Rhythms were recorded before and after intervention .
RESULTS	Twenty-two patients were appropriately entered into the trial .
RESULTS	Eight patients served as controls and 14 patients received aminophylline .
RESULTS	The groups were similar in all measured parameters except for initial rhythm .
RESULTS	None of the patients in the placebo group responded to the intervention .
RESULTS	Half of the patients in the treatment group had return of organized cardiac electrical activity .
CONCLUSIONS	Our results suggest that adenosine receptor antagonism may have a role in the treatment of cardiac asystole .
CONCLUSIONS	Further clinical studies to validate these findings and clarify the appropriate use of adenosine receptor antagonists in cardiac asystole may be justified .

###21212155
BACKGROUND	Sorafenib is a small-molecule multitargeted kinase inhibitor that blocks the activation of C-RAF , B-RAF , c-KIT , FLT-3 , RET , vascular endothelial growth factor receptor 2 ( VEGFR-2 ) , VEGFR-3 and platelet-derived growth factor receptor .
BACKGROUND	The aim of this multicenter , randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer ( NSCLC ) .
METHODS	The trial was designed to select the most promising sorafenib-containing combination in previously untreated elderly ( 70 years ) stage IIIB or IV NSCLC patients , with performance status of zero to two .
METHODS	Patients were randomly assigned to one of the following combinations : gemcitabine , 1200 mg/m ( 2 ) days 1 and 8 , every 21 days , for a maximum of six cycles , plus sorafenib , 800 mg/day , until disease progression or unacceptable toxicity ( arm 1 ) ; or erlotinib , 150 mg/day , plus sorafenib , 800 mg/day , until disease progression or unacceptable toxicity ( arm 2 ) .
METHODS	A selection design was applied with 1-year survival rate as the primary end point of the study , requiring 58 patients .
RESULTS	Sixty patients were randomly allocated to the study ( 31 patients in arm 1 and 29 patients in arm 2 ) .
RESULTS	After a median follow-up of 15 months , 10 patients [ 32 % , 95 % confidence interval ( CI ) 16 % to 49 % ] in arm 1 and 13 patients ( 45 % , 95 % CI 27 % to 63 % ) in arm 2 were alive at 1 year .
RESULTS	Median overall survival was 6.6 and 12.6 months in arm 1 and arm 2 , respectively .
RESULTS	Observed toxic effects were consistent with the expected drug profiles .
CONCLUSIONS	The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm .
CONCLUSIONS	According to the selection design , this combination warrants further investigation in phase III trials .

###20829340
BACKGROUND	Lymph node status is a major determinant of stage and survival in patients with lung cancer ; however , little information is available about the expected yield of a mediastinal lymphadenectomy .
METHODS	The American College of Surgeons Oncology Group Z0030 prospective , randomized trial of mediastinal lymph node sampling vs complete mediastinal lymphadenectomy during pulmonary resection enrolled 1,111 patients from July 1999 to February 2004 .
METHODS	Data from 524 patients who underwent complete mediastinal lymph node dissection were analyzed to determine the number of lymph nodes obtained .
RESULTS	The median number of additional lymph nodes harvested from a mediastinal lymphadenectomy following systematic sampling was 18 with a range of one to 72 for right-sided tumors , and 18 with a range of four to 69 for left-sided tumors .
RESULTS	The median number of N2 nodes harvested was 11 on the right and 12 on the left .
RESULTS	A median of at least six nodes was harvested from at least three stations in 99 % of patients , and 90 % of patients had at least 10 nodes harvested from three stations .
RESULTS	Overall , 21 patients ( 4 % ) were found to have occult N2 disease .
CONCLUSIONS	Although high variability exists in the actual number of lymph nodes obtained from various nodal stations , complete mediastinal lymphadenectomy removes one or more lymph nodes from all mediastinal stations .
CONCLUSIONS	Adequate mediastinal lymphadenectomy should include stations 2R , 4R , 7 , 8 , and 9 for right-sided cancers and stations 4L , 5 , 6 , 7 , 8 , and 9 for left-sided cancers .
CONCLUSIONS	Six or more nodes were resected in 99 % of patients in this study .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00003831 ; URL : clinicaltrials.gov .

###17443649
BACKGROUND	Paclitaxel-eluting stents inhibit restenosis ; however , this technology has drawbacks ( e.g. , stent thrombosis , requirement for long-term antiplatelet therapy , and cost -- particularly for patients with multivessel disease ) .
BACKGROUND	Systemic treatment with a novel 130-nm , albumin-bound particle form of paclitaxel ( nab-paclitaxel ) has been shown to reduce restenosis in animals .
OBJECTIVE	This study was designed to establish the safety and optimal dose of systemic nab-paclitaxel for reducing in-stent restenosis in humans .
OBJECTIVE	If well tolerated , systemic nab-paclitaxel may be used with any available bare-metal stent and at potentially lower cost than drug-eluting stents .
METHODS	Patients received nab-paclitaxel 10 , 30 , 70 , or 100 mg/m ( 2 ) intravenously after stenting of a single de novo lesion > or = 3 mm in diameter .
METHODS	Study endpoints included safety and major adverse cardiac events ( MACE ) at 2 and 6 months .
RESULTS	Data were obtained for all 23 enrolled patients ( mean age 66 + / - 10 years , 74 % men , 26 % with diabetes ) .
RESULTS	No significant adverse events ( AE ) were attributable to nab-paclitaxel at 10 or 30 mg/m ( 2 ) .
RESULTS	Moderate neutropenia , moderate sensory neuropathy , and mild to moderate , reversible alopecia occurred only at doses of 70 and 100 mg/m ( 2 ) ; therefore , doses of 70 mg/m ( 2 ) or higher were considered unacceptable in this patient population .
RESULTS	No MACE were reported at 2 months .
RESULTS	At 6 months , 4 target lesion revascularizations ( TLR ) for restenoses were reported ( 2 each in the 10 - and 100-mg/m ( 2 ) - dose groups ) .
CONCLUSIONS	Systemic nab-paclitaxel was well tolerated at doses below 70 mg/m ( 2 ) in this group of patients ; no unexpected AE were noted .
CONCLUSIONS	Additional studies are under way to explore intravenous and intracoronary administration of nab-paclitaxel .

###16834644
OBJECTIVE	To compare the effects of propiverine and oxybutynin on ambulatory urodynamic monitoring ( AUM ) parameters , safety , and tolerability in patients with overactive bladder .
METHODS	This was a randomized , double-blind , placebo-controlled , multicentre , crossover study .
METHODS	Patients ( n = 77 ) received two of the following treatments during two 2-week periods : propiverine 20 mg once daily , propiverine 15 mg three times daily , oxybutynin 5 mg three times daily , and placebo .
METHODS	AUM parameters , salivary flow , visual near point , and heart rate were assessed .
RESULTS	A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions ( IDCs ; oxybutynin 15 mg < / = propiverine 45 mg < / = propiverine 20 mg ) .
RESULTS	Differences between the oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints .
RESULTS	Statistically significant differences between the oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate ( oxybutynin 15 mg < both propiverine regimens ) and in heart rate variability ( both propiverine regimens < oxybutynin 15 mg ) .
RESULTS	All active treatments lengthened visual near point .
RESULTS	The incidence of dry mouth was significantly more pronounced in the oxybutynin group than in either propiverine group .
RESULTS	Treatment with propiverine 45 mg resulted in the highest rates of constipation , lengthening of the visual near point , and effects on heart rate .
CONCLUSIONS	Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients .
CONCLUSIONS	The primary differences between the two drugs were the incidence and type of adverse events , which varied with the antimuscarinic receptor specificity of each agent .

###14962012
OBJECTIVE	Endogenous adenosine is considered a prominent pain mediator in ischaemia .
OBJECTIVE	In contrast , it has been shown that exogenous adenosine can reduce tourniquet induced ischaemic pain in healthy volunteers .
OBJECTIVE	The aim of this study was to investigate if pharmacological antagonism of endogenous adenosine actions with an intravenous infusion of theophylline could attenuate experimentally induced ischaemic pain .
METHODS	Nineteen healthy volunteers , 11 males , eight female , received theophylline 7 mg kg-1 or placebo intravenously , in a randomized , double blind and crossover fashion , prior to a sub-maximum effort forearm tourniquet test .
METHODS	Experiments were carried out with 1-week intervals to avoid pre-conditioning .
METHODS	Pain scores [ visual analogue scale ( VAS ) , 0-100 ] were assessed every minute up to a maximum of 30 min .
RESULTS	The sum of pain scores ( accumulation of VAS scores ) was attenuated by theophylline , 691 [ 200-1550 ( median and 25-75 % percentiles ) ] , compared with placebo , 1231 ( 545-1675 ) , P < 0.001 .
RESULTS	Also , peak VAS pain was lower during theophylline treatment , 48 + / - 38 ( mean + / - SD ) , compared with placebo , 74 + / - 27 , P < 0.001 .
RESULTS	Blood pressure increased during the experiment with no difference between treatments .
RESULTS	Heart rate was not affected by tourniquet or drug treatment .
CONCLUSIONS	It is concluded that the adenosine receptor antagonist theophylline is able to attenuate the development of ischaemia pain during experimental ischaemia in humans .
CONCLUSIONS	This implies a role for adenosine as both facilitatory mediator and a modulator of ischaemia skeletal muscle pain .

###9626922
OBJECTIVE	Zolpidem is a short-acting imidazopyridine hypnotic which is biotransformed in humans mainly by CYP3A4 .
OBJECTIVE	Itraconazole strongly interacts with many substrates of CYP3A4 such as midazolam and triazolam .
OBJECTIVE	In this study , the effect of itraconazole on the pharmacokinetics and pharmacodynamics of zolpidem was investigated to uncover a possible clinically significant interaction .
METHODS	In a randomized cross-over study with two phases , ten healthy volunteers took either 200 mg itraconazole or placebo once daily for 4 days .
METHODS	A single oral dose of 10 mg zolpidem was given on day 4 .
METHODS	Plasma drug concentrations were measured up to 17 h and effects of zolpidem up to 9 h after the ingestion of zolpidem .
RESULTS	Itraconazole had no marked effects on the pharmacokinetics of zolpidem ; the total area under the plasma zolpidem concentration-time curve ( AUC0-infinity ) was 34 % larger during the itraconazole phase ( 759 ng x h x ml ( -1 ) ) than during the placebo phase ( 567 ng x h x ml ( -1 ) ) .
RESULTS	Exophoria of the eyes by the Maddox wing test was significantly increased by itraconazole , but the results of the digit symbol substitution test , critical flicker fusion test , postural sway tests and the visual analogue scale tests for subjective drowsiness and overall drug effect did not differ between the phases .
CONCLUSIONS	The pharmacokinetics and pharmacodynamics of zolpidem were not remarkably affected by itraconazole in healthy volunteers .
CONCLUSIONS	Therefore , unlike triazolam , for example , zolpidem can be used in normal or nearly normal doses together with itraconazole and probably also with other CYP3A4 inhibitors .

###16100773
OBJECTIVE	To investigate whether p53 expression and apoptosis play a role in the pathogenesis of discoid lupus erythematosus ( DLE ) and whether they are associated with a hyperproliferative state in the epidermis of DLE lesions and epidermal atrophy .
METHODS	A total of 70 skin biopsy specimens , 35 DLE and 35 normal , were used .
METHODS	Expression of protein p53 and Ki-67 was examined immunohistochemically .
METHODS	Apoptotic cells were identified by terminal deoxynucleotidyl transferase ( TdT ) - mediated nick end labeling ( TUNEL ) .
METHODS	Histopathological examination of hematoxylin-eosin-stained sections of DLE included analysis and scoring of epidermal atrophy and other histopathological parameters .
RESULTS	p53 expression was greater in DLE than in normal skin ( 14.5 vs 0.6 % , P < 0.001 ) .
RESULTS	Ki-67 expression was also greater in DLE than in normal skin ( 8.0 vs 3.1 % , P < 0.001 ) .
RESULTS	A significant positive correlation between p53 and Ki-67 expression was found in both groups ( normal skin , r = 0.46 , P < 0.009 ; DLE , r = 0.72 , P < 0.001 ) .
RESULTS	A significant negative correlation ( r = -0.75 , P < 0.001 ) between Ki-67 expression and the intensity of epidermal atrophy was found .
RESULTS	The degree of apoptosis in the epidermis of DLE lesions with higher Ki-67 and p-53 expression was higher than when the expression of these molecules was low ( 3.0 + / -1.8 vs 1.6 + / -1.5 on a scale from 0-5 ; P = 0.048 ) .
CONCLUSIONS	Aberrant p53 expression occurs in the keratinocytes of DLE and is associated with keratinocyte hyperproliferation and epidermal atrophy .
CONCLUSIONS	Accumulation of p53 protein , together with an extensive apoptosis , suggests that the activation of a p53-induced apoptotic pathway may play a role in the pathogenesis of skin lesions in DLE .

###9924327
OBJECTIVE	To compare the tolerability and efficacy of a fixed combination solution of dorzolamide/timolol ( Cosopt ) , administered twice daily with the concomitant administration of its components , dorzolamide ( Trusopt ) twice daily and timolol ( Timoptic ) twice daily .
METHODS	After a 2 week timolol run in , patients with open angle glaucoma or ocular hypertension were randomised ( 1:1 ) to receive treatment with either the dorzolamide/timolol combination solution twice daily ( combination ) or the dorzolamide solution twice daily plus timolol maleate solution twice daily ( concomitant ) for 3 months .
RESULTS	299 patients were entered and 290 patients completed the study .
RESULTS	Compared with the timolol baseline , additional IOP lowering of 16 % was observed at trough ( hour 0 ) and 22 % at peak ( hour 2 ) at month 3 in both the concomitant and combination groups .
RESULTS	The IOP lowering effects of the two treatment groups were clinically and statistically equivalent as demonstrated by the extremely small point differences ( concomitant -- combination ) observed in this study -- 0.01 mm Hg at trough and 0.08 mm Hg at peak .
RESULTS	The safety variables of the concomitant and combination groups were very similar .
RESULTS	Both combination and concomitant therapy were well tolerated and few patients discontinued due to adverse effects .
CONCLUSIONS	The dorzolamide/timolol combination solution administered twice daily is equivalent in efficacy and has a similar safety profile to the concomitant administration of the components administered twice daily .

###7833310
OBJECTIVE	To introduce a simple , well-standardised vaginal ultrasound technique and to compare the position and mobility of the bladder neck in continent and stress incontinent women using this technique .
METHODS	A single-centre prospective case-control study .
METHODS	Ikazia Hospital , Rotterdam , The Netherlands .
METHODS	One hundred and sixty women ; sixty randomly chosen women referred to our outpatient department who volunteered for the study to develop a standardised technique , fifty stress-incontinent women and fifty controls who volunteered for the study for comparison using the standardised technique .
METHODS	Standardisation with regard to bladder volume , horizontal axis and Valsalva force .
METHODS	The position of the bladder neck at rest , during straining and during squeezing .
RESULTS	The probe we use does not alter bladder neck mobility .
RESULTS	A standardised bladder volume of 250 ml was used rather than maximum bladder capacity .
RESULTS	A Foley catheter introduced into the bladder , with the balloon half-filled with soapy water and half with air gives an easily recognisable fluid level , which is parallel to the horizontal axis of the patient .
RESULTS	A standardised Valsalva force of 30 cm H2O can exclude differences in bladder neck mobility due to spontaneous and uncontrolled abdominal force .
RESULTS	Measurements by two independently working investigators showed good conformity .
RESULTS	The position of the bladder neck in the stress incontinent women was significantly lower and significantly more posterior at rest , during straining and during squeezing .
RESULTS	At the same time in stress incontinent women there was significantly more descent during straining and less elevation during squeezing .
RESULTS	However , there was a considerable overlap between the two groups for all parameters .
CONCLUSIONS	This standardised vaginal ultrasound technique is a feasible , acceptable and reproducible technique for the study of female bladder neck mobility .
CONCLUSIONS	The position and mobility of the bladder neck is significantly different in stress incontinent women as compared to continent controls .
CONCLUSIONS	The great overlap between the two groups still limits the clinical relevance .

###25593120
BACKGROUND	Chronic kidney disease ( CKD ) is strongly related to outcome in cardiovascular diseases .
BACKGROUND	The relationship between treatment of mitral regurgitation ( MR ) and renal function is not well described .
BACKGROUND	We sought to evaluate renal function before and after mitral valve repair by the MitraClip device .
RESULTS	Patients with moderate-to-severe or severe ( 3 + or 4 + , respectively ) MR by core laboratory determination who underwent transcatheter mitral valve repair with the MitraClip device in multicenter , investigational trials were included in this study .
RESULTS	Estimated glomerular filtration rate ( eGFR ) was evaluated before and at hospital discharge , 30 days , 6 months , and 1 year after mitral valve repair .
RESULTS	Eight hundred fifty-four patients with baseline mean eGFR 61.5 23.1 mL/min/1 .73 m ( 2 ) were studied , including 438 ( 51.3 % ) with eGFR 60 mL/min/1 .73 m ( 2 ) ( CKD stage 1 or 2 ) , 371 ( 42.6 % ) with eGFR 30 to 59 mL/min/1 .73 m ( 2 ) ( CKD stage 3 ) , and 52 ( 6.1 % ) with eGFR < 30 mL/min/1 .73 m ( 2 ) ( CKD stage 4 or 5 ) .
RESULTS	Baseline renal dysfunction was more prevalent in older patients with a history of heart failure , coronary artery disease , cerebrovascular disease , diabetes mellitus , hypertension , and atrial fibrillation .
RESULTS	Baseline eGFR was associated with 1-year survival ( P < 0.001 ) after MitraClip repair .
RESULTS	At 1-year follow-up , the mean change in eGFR for the overall cohort was -1.0 15.1 mL/min/1 .73 m ( 2 ) ; for patients with CKD stage 1 or 2 , stage 3 , or stage 4 or 5 , mean change was -4.1 16.6 , +2.6 12.4 , and +4.8 9.5 mL/min/1 .73 m ( 2 ) , respectively .
RESULTS	Linear mixed effect modeling demonstrated a strong association between MR and eGFR , and a statistically significant improvement in eGFR in patients with CKD stage 4 or 5 associated with MR reduction to 2 + ( P = 0.007 ) .
CONCLUSIONS	Renal dysfunction is associated with lower survival in patients with severe MR even after percutaneous mitral valve repair .
CONCLUSIONS	Reduction in MR severity by the MitraClip device is associated with improvement in renal function at 1 year in patients with baseline renal dysfunction .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : NCT00209274 , NCT01931956 , NCT01940120 .

###7701266
BACKGROUND	Gastrointestinal fistulas are a serious complication of gastrointestinal tract surgery : they are often accompanied by high levels of morbidity and mortality .
BACKGROUND	Among other things , some fistula characteristics ( anatomical site , type of tract , time elapsed to fistula appearance and volume of output ) are being considered as of great importance .
BACKGROUND	New therapeutic approaches such as somatostatin are nowadays being tested in order to clarify the benefits of its use .
METHODS	A multi-centre , randomized , controlled and prospective trial was carried out ( n = 40 , March-December , 1988 ) to evaluate the effectiveness of total parenteral nutrition ( TPN ) versus TPN + somatostatin in the conservative management of postoperative gastrointestinal fistulas .
METHODS	Since January 1989 , wider inclusion criteria have been followed , and all patients ( n = 63 ) who have fulfilled inclusion criteria have been admitted to TPN plus somatostatin treatment .
RESULTS	Closure time of fistulas in patients receiving TPN + somatostatin was significantly shorter ( 13.86 + / - 1.84 versus 20.4 + / - 2.89 days ) than in those receiving TPN alone .
RESULTS	In the second phase of the study , more time was needed to obtain complete closure of fistulas ( 15.8 days ) .
CONCLUSIONS	Somatostatin is a useful therapeutic complement in the management of postoperative gastrointestinal fistulas , since it accelerates their spontaneous closure .

###22040307
BACKGROUND	The majority of retirement village residents are at risk of medication misadventure .
BACKGROUND	In a recent survey of retirement village residents in Victoria , two-thirds had at least one medication-related risk factor , and hence were eligible to receive a government-subsidised Home Medicines Review ( HMR ) .
BACKGROUND	However , only 6 % of eligible residents had received a HMR in the previous 12 months .
BACKGROUND	Reasons for the poor uptake of HMR , and interventions for improving HMR uptake , have been identified and developed with input from stakeholders .
BACKGROUND	The trial will test the effect of Pharmacist-conducted HMR to Address the Risk of Medication-related Events in Retirement Villages ( PHARMER ) in improving the uptake of HMRs among retirement village residents .
METHODS	This is a multicentre prospective cluster randomised controlled trial .
METHODS	Ten retirement villages in Victoria , Australia will be recruited for this trial .
METHODS	Retirement villages will be selected in consultation with the Residents of Retirement Villages Victoria Inc. ( RRVV ) , based on geographical locations ( e.g. northeast or southwest ) , size and other factors .
METHODS	Residents from selected villages will be recruited with the help of RRVV Resident Liaison Officers using a range of strategies .
METHODS	Randomisation will be by geographical location to minimise contamination .
METHODS	Participating villages and residents will be allocated to either Pharmacist Intervention Group ( PIG ) or Usual Care Group ( UCG ) .
METHODS	Each group will include five retirement villages and will have at least 77 residents in total .
METHODS	The intervention ( PHARMER ) comprises educating residents regarding HMR , and using a risk assessment checklist by residents to notify their General Practitioners of their medication risk .
METHODS	Uptake of HMR and medication adherence will be assessed in both PIG and UCG at three and six months using telephone interviews and questionnaires .
CONCLUSIONS	This study is the first to develop and test an intervention to improve the uptake of HMR among Australian residents in retirement villages , with a view to decreasing medication risk .
CONCLUSIONS	A multi-faceted interventional approach will be used as suggested by stakeholders .
CONCLUSIONS	The trial is expected to be complete by late 2011 and results will be available in 2012 .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12611000109909 ) .

###22089446
BACKGROUND	Nutritional factors during a sensitive period can influence child development in a sex-related manner .
OBJECTIVE	Our aim was to investigate whether sex modulates the responses of relevant biochemical parameters and growth to different protein intakes early in life .
METHODS	In a randomized controlled trial , formula-fed infants were assigned to receive formula with higher protein ( HP ) or lower protein ( LP ) content .
METHODS	The main outcome measures were insulin-like growth factor ( IGF ) -1 axis parameters , weight , length , BMI , leptin , and C-peptide/creatinine ratio at 6 mo of age .
METHODS	Dietary intake during the first 6 mo of life was also assessed .
RESULTS	The IGF-1 axis response to HP feeding was modulated by sex .
RESULTS	Total and free IGF-1 and IGF binding protein 3 concentrations were higher in girls than in boys .
RESULTS	Compared with the LP diet , the HP diet was associated with higher IGF-1 and lower IGF binding protein 2 secretion .
RESULTS	The response to this HP content formula tended to be stronger in girls than in boys .
RESULTS	The HP diet was associated with a higher C-peptide/creatinine ratio .
RESULTS	The leptin concentration was higher in girls than in boys and was correlated to the IGF-1 axis parameters .
RESULTS	No interaction between sex and nutritional intervention was shown on growth .
CONCLUSIONS	Our findings show that the endocrine response to a high protein diet early in life may be modulated by sex .
CONCLUSIONS	The IGF-1 axis of female infants shows a stronger response to the nutritional intervention than does that of male infants , but there is no enhanced effect on growth .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00338689 .

###19815286
OBJECTIVE	To investigate the impact of an intervention program to improve adherence with topical , once daily therapy for glaucoma .
METHODS	Randomized controlled clinical trial .
METHODS	Sixty-six patients with glaucoma being treated with a prostaglandin analog in 1 or both eyes at the Scheie Eye Institute or Wilmer Eye Institute between November 2006 and June 2007 .
METHODS	In an observational study , participants who took 75 % or fewer doses ( as measured using the travoprost Dosing Aid [ DA ] ) during an initial 3-month period were randomized into 2 groups .
METHODS	The intervention group watched an educational video , reviewed current barriers to drop-taking and possible solutions with a study coordinator , received regular phone call reminders , and had audible and visible reminders activated on their DA devices .
METHODS	The control group was told to take drops as prescribed and received no additional intervention .
METHODS	Change in drop use adherence as determined by the DA device .
RESULTS	In the 3-month observation period before randomization , intervention group patients had used a mean of 54 + / -17 % of scheduled doses , and this increased to 73 + / -22 % during the following 3-month period ( P < 0.001 , n = 35 ) .
RESULTS	The control mean adherence rate of 46 + / -23 % at baseline was statistically unchanged during the follow-up observation period ( 51 + / -30 % , P = 0.16 , n = 31 ) .
RESULTS	In a multivariate analysis , intervention , baseline compliance rate of < 50 % , and white ethnicity were predictors of improved adherence during the 3 months of intervention .
RESULTS	The intraocular pressure ( IOP ) of the intervention and control groups did not change between months 3 and 6 after intervention ( P = 0.96 , 0.34 , respectively ) , and there was no correlation of IOP change with adherence rate change between both groups ( Pearson correlation r = 0.06 , P = 0.51 ) .
CONCLUSIONS	A multifaceted intervention significantly increased adherence with glaucoma medications .
CONCLUSIONS	Those with improved adherence were in the intervention group , had very low adherence rates at baseline , and were white .
CONCLUSIONS	IOP did not correlate with adherence .
CONCLUSIONS	Further research is needed to determine which components of this intervention were most effective .

###7852918
OBJECTIVE	The purpose of this study was to test the hypothesis that the reduction of body iron stores by venesection ( blood letting ) would reduce the susceptibility to oxidation of atherogenic serum lipoproteins .
METHODS	This is a randomized , controlled cross-over trial in 14 regularly smoking men with elevated serum ferritin concentration .
METHODS	The study design comprised two 14-week study periods , with a 14-week wash-out period in between , with either blood donations or control .
METHODS	The study site was the Research Institute of Public Health , University of Kuopio .
METHODS	Investigators from the Division of Epidemiology , University of Minnesota , Minneapolis , participated in the planning of the study .
METHODS	Fourteen volunteers who were heavy smokers and had previous experience in blood letting were recruited for the study .
METHODS	During the intervention periods , the subjects donated 450 mg ( 500 mL ) of blood three times in 14 weeks .
METHODS	Oxidation resistance of very low density lipoprotein ( VLDL ) / low density lipoprotein ( LDL ) was measured after inducing oxidation with haemin and H2O2 .
RESULTS	Serum ferritin concentration was reduced by 44 % [ 95 % confidence interval ( CI ) 8-82 % , P = 0.021 ] during the venesection periods , the maximal oxidation velocity was decreased by 20 % ( 95 % CI 3-30 % , P = 0.032 ) , and the lag time to start of oxidation was lengthened ( oxidation resistance increased ) by 33 % ( 95 % CI 1-64 % , P = 0.036 ) .
CONCLUSIONS	These observations indicate that the reduction of body iron stores by venesection can increase the oxidation resistance of serum VLDL/LDL in regularly smoking men .

###23803042
BACKGROUND	Breast cancer is one of the most frequent diseases in women today .
BACKGROUND	Little information exists on modifiable lifestyle factors including effects of ginger supplements ( as an anti-oxidant and anti-inflammatory herbal ) and water-based exercise on biomarkers related to oxidative stress such as malondialdehyde ( MDA ) , nitric oxide ( NO ) and glutathione peroxidase ( GPx ) and adiponectin in obese women with breast cancer .
BACKGROUND	The aim of this study was to determine the single and concomitant effect of 6-wks water-based exercise and oral ginger supplement on the aforesaid markers in obese women with breast cancer .
METHODS	Forty women diagnosed with breast cancer ( 48 5.4 years , 76 9 kg , fat mass 41.8 4 % ) , volunteered to participate in the study .
METHODS	Subjects were randomly assigned into four groups ; placebo , water-based exercise , ginger supplement and water-based exercise + ginger supplement groups .
METHODS	Subjects in the ginger supplement group and the water-based exercise + ginger supplement group orally received 4 capsules ( each capsule contained 750 mg ) , 7 days a week for 6 weeks .
METHODS	The water-based exercise program featured progressive increase in intensity and time , ranging from 50 % to 75 % of heart rate reserve , in a pool with 15 meters width , 4 times a week for 6 weeks .
METHODS	Fasting blood samples were collected at pre-test and post-test time points .
RESULTS	The ginger supplementation and or the water-base exercise resulted in an increase of adiponectin , NO and GPx and reduction MDA , as compared to pre-test values .
RESULTS	However , the combined intervention ( water-base exercise and ginger supplement ) group showed significantly a far better effect on the biomarkers related to oxidative stress and adiponectin levels , as compared to the water - base exercise or ginger supplement alone groups and the age-matched placebo group .
CONCLUSIONS	Our results revealed that water-base exercise is a non-drug therapeutic strategy to reduce systemic stress in obese women suffering from breast cancer .
CONCLUSIONS	Further , ginger supplementation alone or in combination with training , also play an important role in the pathogenesis of oxidative stress in obese women diagnosed with breast cancer .

###9126089
OBJECTIVE	To compare the influence of a daily dose of 20 or 40 mg of the serotonergic antidepressant drug paroxetine in delaying ejaculation in patients with primary premature ejaculation .
METHODS	Thirty-four patients with primary premature ejaculation were randomly assigned to receive 20 mg or 40 mg daily of paroxetine for 7 weeks in a double-blind fixed-dose trial after an initial dose of 20 mg/day in the first week .
METHODS	Patients and their female partners were interviewed separately .
METHODS	In the group receiving 20 mg , one of two capsules consisted of placebo and in the group receiving 40 mg , both capsules contained active drug .
RESULTS	The trial was completed by 27 men ; both groups showed a statistically significant difference from the baseline values of ejaculation latency ( P < 0.001 ) and a clinically relevant improvement in ejaculation time .
RESULTS	The increase in the intravaginal ejaculation latency time was not statistically significant different between the groups .
RESULTS	The patient 's assessments were confirmed independently by their partners .
CONCLUSIONS	The daily use of 20 mg paroxetine may be considered as an adequate treatment for primary premature ejaculation .
CONCLUSIONS	Increasing the dose may lead to a further increase in ejaculation latency .

###11092281
OBJECTIVE	To evaluate the efficacy and safety of four doses of pioglitazone monotherapy in the treatment of patients with type 2 diabetes .
METHODS	There were 408 patients randomized in this multicenter double-blind placebo-controlled clinical trial .
METHODS	Patients who had HbA1c > or = 7.0 % , fasting plasma glucose ( FPG ) > or = 140 mg/dl , and C-peptide > 1 ng/ml were randomized to receive placebo or 7.5 , 15 , 30 , or 45 mg pioglitazone administered once a day for 26 weeks .
RESULTS	Patients treated with 15 , 30 , or 45 mg pioglitazone had significant mean decreases in HbA1c ( range -1.00 to -1.60 % difference from placebo ) and FPG ( -39.1 to -65.3 mg/dl difference from placebo ) .
RESULTS	The decreases in FPG were observed as early as the second week of therapy ; maximal decreases occurred after 10-14 weeks and were maintained until the end of therapy ( week 26 ) .
RESULTS	In the 15 - , 30 - , or 45-mg pioglitazone groups , there were significant mean percent decreases in triglycerides , significant mean percent increases in HDL cholesterol , and only small percent changes in total cholesterol and LDL .
RESULTS	The subset of patients naive to therapy had greater improvements in HbA1c and FPG ( difference from placebo of -2.55 % and -79.9 mg/dl for the 45-mg group ) compared with previously treated patients .
RESULTS	The overall adverse event profile of pioglitazone was similar to that of placebo .
RESULTS	There was no evidence of drug-induced hepatotoxicity or drug-induced elevations of alanine aminotransferase levels in this study
CONCLUSIONS	Pioglitazone monotherapy significantly improves HbA1c and FPG while producing beneficial effects on serum lipids in patients with type 2 diabetes with no evidence of drug-induced hepatotoxicity .

###21383272
OBJECTIVE	To investigate whether licensed media spokescharacters on food packaging and nutrition cues affect young children 's taste assessment of products .
METHODS	In this experimental study , children viewed 1 of 4 professionally created cereal boxes and tasted a `` new '' cereal .
METHODS	Manipulations included presence or absence of licensed cartoon spokescharacters on the box and healthy or sugary cereal name .
METHODS	Shopping center in a large northeastern city in December 2007 .
METHODS	Eighty children ( mean [ SD ] age , 5.6 [ 0.96 ] years ; 53 % girls ) and their parents or guardians .
METHODS	Licensed cartoon characters and nutrition cues in the cereal name .
METHODS	Children rated the cereal 's taste on a 5-point smiley face scale ( 1 , really do not like ; 5 , really like ) .
RESULTS	Children who saw a popular media character on the box reported liking the cereal more ( mean [ SD ] , 4.70 [ 0.86 ] ) than those who viewed a box with no character on it ( 4.16 [ 1.24 ] ) .
RESULTS	Those who were told the cereal was named Healthy Bits liked the taste more ( mean [ SD ] , 4.65 [ 0.84 ] ) than children who were told it was named Sugar Bits ( 4.22 [ 1.27 ] ) .
RESULTS	Character presence was particularly influential on taste assessments for participants who were told the cereal was named Sugar Bits .
CONCLUSIONS	The use of media characters on food packaging affects children 's subjective taste assessment .
CONCLUSIONS	Messages encouraging healthy eating may resonate with young children , but the presence of licensed characters on packaging potentially overrides children 's assessments of nutritional merit .

###17484223
BACKGROUND	The 2-fold increase in female mortality after high-titer measles vaccine may have occurred because many children received diphtheria-tetanus-pertussis ( DTP ) vaccine or inactivated polio vaccine ( IPV ) after high-titer measles vaccine .
OBJECTIVE	We examined whether DTP vaccine and IPV were associated with increased female mortality when they were the most recent vaccine administered to children who had not received measles vaccine .
METHODS	IPV was used as a control vaccine in 4 randomized trials of early measles vaccination ( MV ) with enrollment at 4-6 months of age conducted in Guinea-Bissau .
METHODS	Many children had not received all 3 DTP vaccinations before enrollment , and therefore received DTP after IPV or MV .
METHODS	We examined whether DTP vaccination status at enrollment affected the female-male mortality ratio .
METHODS	9544 children enrolled in 4 trials .
METHODS	The female-male mortality ratio in different vaccine groups .
RESULTS	Females had a higher mortality rate than males among children randomized to receive IPV ( mortality rate ratio [ MR ] 1.52 , 95 % CI 1.02-2 .28 ) , but females had a similar mortality rate to males among children randomized to receive MV ( MR 1.01 , 0.69-1 .46 ) and among children in the IPV group after they had received MV at 9 months of age or later ( MR 0.88 , 0.68-1 .14 ) .
RESULTS	Children who had not received a third dose of DTP before enrollment ( and were likely to receive DTP after MV or IPV ) tended to have a higher mortality than children who had received all 3 doses of DTP ( MR 1.30 , 0.97-1 .73 ) .
RESULTS	This effect was seen only among girls ( MR 1.61 , 1.08-2 .40 ) and not among boys ( MR 1.02 , 0.67-1 .54 ) .
RESULTS	Girls had a lower mortality when MV was the most recent vaccine received rather than DTP or IPV ( MR 0.49 , 0.28-0 .87 ) .
CONCLUSIONS	Randomization to IPV was associated with higher female than male mortality .
CONCLUSIONS	However , the increased female mortality might result from additional doses of DTP received after enrollment and before measles vaccination .

###18317068
OBJECTIVE	To determine the optimal doses of the antiepidermal growth factor receptor ( anti-EGFR ) monoclonal antibody cetuximab and the EGFR tyrosine kinase inhibitor gefitinib when administered as a combination for patients with advanced/metastatic non-small cell lung cancer ( NSCLC ) previously treated with platinum-based chemotherapy .
METHODS	Patients with advanced/metastatic NSCLC treated with prior platinum-based chemotherapy received escalating doses of weekly cetuximab ( 100 , 200 , and 250 mg/m ( 2 ) , IV ) and fixed doses of gefitinib ( 250 mg/d , PO ) until disease progression or unacceptable toxicity .
METHODS	Available tumor samples were analyzed for EGFR expression , EGFR gene copy number and mutations , and K-RAS mutations .
RESULTS	Thirteen patients were enrolled in three cohorts .
RESULTS	Treatment was generally well-tolerated at all doses .
RESULTS	One grade 3 headache , observed on the first treatment cycle was initially considered dose-limiting toxicity ( DLT ) ; this event was eventually determined to be caused by a brain metastasis , not toxicity .
RESULTS	Three cases of grade 3/4 hypomagnesemia and 1 case of grade 3 skin rash occurred in the highest-dose cohort .
RESULTS	Grade 1/2 infusion reactions occurred in three patients without requiring treatment discontinuation .
RESULTS	Four patients ( 31 % ) achieved stable disease , no responses were observed .
RESULTS	None of the patients had EGFR mutations or gene amplification in their tumor samples .
CONCLUSIONS	Dual EGFR inhibition with cetuximab and gefitinib is feasible ; the combination can be safely administered and may have modest activity in advanced/metastatic NSCLC .
CONCLUSIONS	Cetuximab 250 mg/m ( 2 ) weekly IV and gefitinib 250 mg/d PO is the recommended phase II dose , although the potential for late-onset hypomagnesemia warrants close monitoring of patients receiving this combined dosage .

###12837861
OBJECTIVE	To evaluate the effect of early range-of-motion intervention on bone strength and bone turnover in very low birth weight infants .
METHODS	Twenty-four infants ( mean birth weight : 1135 + / - 247 g ; mean gestational age : 28.5 + / - 2.3 weeks ) were matched for gestational age and birth weight and then randomly assigned into exercise ( n = 12 ) and control ( n = 12 ) groups .
METHODS	Exercise protocol started at the first week of life and involved daily extension and flexion range of motion against passive resistance of the upper and lower extremities ( 5 minutes per day , 5 days per week , 4 weeks ) .
METHODS	Growth parameters , bone strength , and biochemical markers of bone homeostasis were measured at enrollment and after 4 weeks .
METHODS	Bone strength was determined using quantitative ultrasound measurement of bone speed of sound ( SOS ) at the middle left tibial shaft .
RESULTS	Bone SOS decreased significantly in the control group during the study period ( from 2892 + / - 30 m/sec to 2799 + / - 26 ) , whereas bone SOS of the exercise group remained stable ( 2825 + / - 32 m/sec and 2827 + / - 26 m/sec at baseline and 4 weeks , respectively ) .
RESULTS	This significant difference in bone SOS was not expressed in the biochemical markers of bone homeostasis .
CONCLUSIONS	There is a significant postnatal decrease in the bone SOS of very low birth weight infants .
CONCLUSIONS	A brief range-of-motion exercise attenuates the decrease in bone strength and may decrease the risk of osteopenia .

###11347792
OBJECTIVE	This study explored reasons why older adults with urinary incontinence ( UI ) do not initiate discussions with or seek treatment for UI from their primary care provider .
METHODS	A randomized , prospective controlled trial involving 41 primary care sites .
METHODS	Primary care practice sites .
METHODS	49 older adults age 60 and older not previously screened for UI by their primary care doctor .
METHODS	Demographic data , self-reported bladder-control information using questionnaires , and health status .
RESULTS	Adults who did not discuss UI were older , had less-frequent leaking accidents and fewer nighttime voids and were less bothered by UI than those who did .
RESULTS	The two main reasons why patients did not seek help were the perceptions that UI was not a big problem ( 45 % ) and was a normal part of aging ( 19 % ) .
CONCLUSIONS	Embarrassment or lack of awareness of treatment options were not significant barriers to discussing UI .
CONCLUSIONS	Adults with a fairly high frequency of UI ( average of 1.7 episodes per day ) did not view UI as abnormal or a serious medical condition .

###12139908
OBJECTIVE	to compare the experiences of women who received a new model of continuity of midwifery care with those who received standard hospital care during pregnancy , labour , birth and the postnatal period .
METHODS	a randomised controlled trial was conducted .
METHODS	One thousand and eighty-nine women were randomly allocated to either the new model of care , the St George Outreach Maternity Project ( STOMP ) , or standard care .
METHODS	Women completed a postal questionnaire eight to ten weeks after the birth .
METHODS	women in the trial were of mixed obstetric risk status and more than half the sample were born in a non-English speaking country .
RESULTS	questionnaires were returned from 69 % of consenting women .
RESULTS	STOMP women were significantly more likely to have talked with their midwives and doctors about their personal preferences for childbirth and more likely to report that they knew enough about aspects of labour and birth , particularly induction of labour , pain relief and caesarean section .
RESULTS	Almost 80 % of women in the STOMP group experienced continuity of care , that is , one of their team midwives was present , during labour and birth .
RESULTS	STOMP women reported a significantly higher ` sense of control during labour and birth ' .
RESULTS	Sixty-three per cent of STOMP women reported that they ` knew ' the midwife who cared for them during labour compared with 21 % of control women .
RESULTS	In a secondary analysis , women who had a midwife during labour who they felt that they knew , had a significantly higher sense of ` control ' and a more positive birth experience compared with women who reported an unknown midwife .
RESULTS	Postnatal care elicited the greatest number of negative comments from women in both the STOMP and the control group .
CONCLUSIONS	The reorganisation of maternity services to enable women to receive continuity of care has benefits for women .
CONCLUSIONS	The benefits of a known labour midwife needs further research .

###9696640
BACKGROUND	Long-term treatment with antiviral agents has been shown to prevent recurrences of genital and orofacial herpes simplex virus ( HSV ) disease , but it is uncertain whether prophylactic treatment can prevent recurrences of ocular HSV disease .
METHODS	We randomly assigned 703 immunocompetent patients who had had ocular HSV disease within the preceding year to receive 400 mg of acyclovir or placebo orally twice daily .
METHODS	The study outcomes were the rates of development of ocular or nonocular HSV disease during a 12-month treatment period and a 6-month observation period .
RESULTS	The cumulative probability of a recurrence of any type of ocular HSV disease during the 12-month treatment period was 19 percent in the acyclovir group and 32 percent in the placebo group ( P < 0.001 ) .
RESULTS	Among the 337 patients with a history of stromal keratitis , the most common serious form of ocular HSV disease , the cumulative probability of recurrent stromal keratitis was 14 percent in the acyclovir group and 28 percent in the placebo group ( P = 0.005 ) .
RESULTS	The cumulative probability of a recurrence of nonocular ( primarily orofacial ) HSV disease was also lower in the acyclovir group than in the placebo group ( 19 percent vs. 36 percent , P < 0.001 ) .
RESULTS	There was no rebound in the rate of HSV disease in the six months after treatment with acyclovir was stopped .
CONCLUSIONS	After the resolution of ocular HSV disease , 12 months of treatment with acyclovir reduces the rate of recurrent ocular HSV disease and orofacial HSV disease .
CONCLUSIONS	Long-term antiviral prophylaxis is most important for patients with a history of HSV stromal keratitis , since it can prevent additional episodes and potential loss of vision .

###21422302
OBJECTIVE	To determine if pretonsillectomy injection of local anesthetics with and without clonidine reduces pain following tonsillectomy in children .
METHODS	A prospective , randomized , double-blind , placebo-controlled trial .
METHODS	Tertiary care academic medical center .
METHODS	A total of 120 children , ages 3 to 17 years , presenting for tonsillectomy .
METHODS	Patients were randomized to 1 of 3 pretonsillectomy injection groups : ( 1 ) saline , ( 2 ) lidocaine plus bupivacaine , or ( 3 ) lidocaine plus bupivacaine plus clonidine .
METHODS	The total number of analgesic doses consumed on postoperative days ( PODs ) 1 , 3 , 5 , and 7 .
METHODS	Secondary outcome variables included total time and intravenous analgesic doses required in the recovery room , visual analog scale pain scores , and maximum tolerated diet on postoperative days 1 , 3 , 5 , and 7 .
RESULTS	The total number of analgesic doses on PODs 1 , 3 , 5 , and 7 were not significantly different between the randomization groups ( P = .53 ) .
RESULTS	The median numbers ( interquartile ranges ) of analgesic doses were 12.0 ( 9.0-16 .8 ) for the lidocaine plus bupivacaine plus clonidine group , 12.0 ( 10.0-16 .5 ) for the lidocaine plus bupivacaine group , and 14.0 ( 9.0-15 ) for the placebo group .
RESULTS	The placebo group was found to have a more advanced diet on POD 1 ( P = .04 ) and significantly less pain on POD 3 ( P = .02 ) .
RESULTS	Multivariable analysis showed children in the lidocaine plus bupivacaine plus clonidine group were significantly less likely to need intravenous pain medication in the recovery room compared with children in the placebo group and again showed that the placebo group achieved a significantly more advanced diet and had less pain on PODs 1 and 3 .
CONCLUSIONS	Pretonsillectomy injection of lidocaine , 1 % , and bupivacaine , 0.5 % , with or without clonidine ( 25 g ) is not recommended for the reduction of posttonsillectomy pain .
BACKGROUND	clinicaltrials.gov Identifier : NCT00678379 .

###18623974
OBJECTIVE	This study set out to evaluate the prevalence of iatrogenic events during preclinical teaching of endodontics , comparing manual stainless steel versus nickel-titanium ( Ni-Ti ) rotary techniques for shaping natural root canals .
METHODS	Two groups of 13 inexperienced dental students were randomly made up and asked to shape 104 canals in natural teeth .
METHODS	Group R used Ni-Ti rotary files for shaping while Group M used a sequence of five manual stainless steel files .
METHODS	Occurrence of file breakage , loss of work length , and iatrogenic instrumentation on apical foramina were evaluated .
RESULTS	Overall occurrence of adverse events during shaping did not differ between the groups , being 58 % in Group R and 51 % in Group M. Inter-group distribution of type of event differed significantly , however .
RESULTS	File breakage ( 7.7 % ) and loss of working length of > 2 mm ( 6.7 % ) occurred only in Group R. Iatrogenic shaping on apical foramina showed the same frequency in each group .
CONCLUSIONS	Manual instrumentation is safer than rotary instrumentation in the hands of inexperienced students .
CONCLUSIONS	Acquiring skill in the use of Ni-Ti rotary instrumentation requires specific preclinical training to avert file breakage .
CONCLUSIONS	These findings argue for the rethinking of theoretical and practical coursework in endodontics teaching , especially in dentistry schools where students are required to treat patients during their training .

###25464418
BACKGROUND	The elderly ( 75years ) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly ( < 75years ) .
BACKGROUND	Whether the effects of everolimus-eluting stent ( EES ) in ST-segment elevation myocardial infarction ( STEMI ) are independent of age has not been reported .
BACKGROUND	We investigated the outcomes following primary PCI ( PPCI ) with bare-metal stent ( BMS ) or EES in elderly vs. non-elderly STEMI patients .
METHODS	The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES .
METHODS	The primary patient-oriented endpoint ( POCE ) was the combined of all-cause death , any-recurrent myocardial infarction ( MI ) and any-revascularization at 1-year .
METHODS	The secondary endpoint included the device-oriented combined ( DOCE ) of cardiac death , target-vessel MI and target-lesion revascularization .
METHODS	These endpoints and their components were compared between elderly and non-elderly .
RESULTS	Among patients enrolled in the trial , 245 ( 16.3 % ) were elderly , allocated to BMS ( n = 132 ) or EES ( n = 113 ) , while the remaining 1253 ( 83.7 % ) were non-elderly , allocated to BMS ( n = 615 ) or EES ( n = 638 ) .
RESULTS	At 1-year , both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group ( 24.5 % vs. 10.5 % , p < 0.001 and 15.9 % vs. 5.1 % , p < 0.001 ) .
RESULTS	Whereas in non-elderly , both POCE and DOCE were lower in EES vs. BMS ( 12.4 % vs. 8.8 % , p = 0.03 and 6.7 % vs. 3.6 % , p = 0.01 ) , no differences were found in elderly , with a tendency for interaction between age and stent type for POCE ( p = 0.05 ) .
RESULTS	On multivariate analysis age 75 years was an independent predictor of POCE ( HR 2.19 [ 95 % CI 1.59-3 .01 ] , p < 0.0001 ) and DOCE ( HR 2.42 [ 95 % CI 1.60-3 .7 ] , p < 0.001 ) at 1-year .
CONCLUSIONS	In STEMI patients undergoing PPCI , advanced age ( 75 years ) is associated with worse outcomes .
CONCLUSIONS	The beneficial effects of EES over BMS tended to be age-dependent .

###21254854
BACKGROUND	Psoriasis is a common chronic disease .
BACKGROUND	It is estimated that between US$ 1.6 billion and US$ 3.2 billion is spent per year to treat psoriasis .
OBJECTIVE	To compare psoralen plus UV-A ( PUVA ) therapy with topical steroids in moderate plaque psoriasis .
METHODS	In this randomized , clinical trial with cost analysis , 88 patients with moderate plaque psoriasis were recruited in two equal groups to receive either PUVA therapy or topical steroids .
METHODS	The induction phase was applied for 4 months and the patients were followed-up for another 3 months , while the maintenance therapy continued .
METHODS	Outcome , direct cost ( related to medications , phototherapy , laboratory tests , and medical consultation ) , indirect cost ( related to transportation and other extra expenditures ) and total cost ( direct plus indirect costs ) were compared between the two groups .
RESULTS	The outcome was equally satisfactory in both groups .
RESULTS	The indirect cost was significantly higher in the PUVA group , while the direct and total costs as well as the patients ' satisfaction rate were comparable .
RESULTS	Recurrence was significantly more frequent in the topical group .
CONCLUSIONS	Although both PUVA therapy and topical steroids are equally efficient and cost-effective in moderate plaque psoriasis , the recurrence rate is higher in the latter group .

###16245914
OBJECTIVE	To investigate the effect of Shenmai injection on chronic aplastic anemia patients and its mechanism .
METHODS	Sixty-five chronic aplastic anemia patients were randomized into treatment group and control group .
METHODS	The patients of the treatment group were treated by injecting Shenmai injection and taking western medicine orally , those of the control group taking western medicine orally only , then the effect was evaluated .
METHODS	The concentration of tumor necrosis factor-alpha ( TNF-alpha ) in blood serum was detected and the apoptosis of bone marrow CD34 + cell was analysed by DNA ISEL technic before and after treatment .
RESULTS	The effective rate of the treatment group and the control group was 63.6 % and 40.6 % respectively , the effect of the Shenmai injection on the treatment group was obviously better than that of the control group ( P < 0.01 ) .
RESULTS	Before treatment , the concentration of TNF-alpha in blood serum and the apoptosis rate of bone marrow CD34 + cell of the chronic aplastic anemia patient were higher than normal ( P < 0.01 ) .
RESULTS	After treatment , the concentration of TNF-alpha in blood serum of the treatment group decreased obviously ( P < 0.01 ) , and the apoptosis rate of bone marrow CD34 + cell of the treatment group also decreased ( P < 0.05 ) , which had significant difference compared with those of the control group ( P < 0.05 ) .
CONCLUSIONS	Shenmai injection is efficient to chronic aplastic anemia .
CONCLUSIONS	The mechanism is decreasing the concentration of TNF-alpha in blood serum and the apoptosis rate of bone marrow CD34 + cell .

###18798228
OBJECTIVE	Weight disorders and overeating are increasingly labeled as addictions .
OBJECTIVE	It is important to identify the consequences of this label on the stigmatization of obesity .
METHODS	Participants ( N = 374 ) were assigned randomly to one of six conditions , in which they read a scenario about an obese woman either with or without binge eating , followed by an account of the cause of her obesity as psychological , a biological addiction , or ambiguous .
METHODS	Participants then completed questionnaires designed to assess stigma and prognostic beliefs .
RESULTS	Participants in the obesity with binge eating condition rated obese persons more negatively and as having a worse prognosis .
RESULTS	The causal manipulation check revealed no difference between groups and there were no significant effects of this condition .
CONCLUSIONS	Behavior ( binge eating ) has important implications for understanding the stigmatization of obesity .

###7836734
OBJECTIVE	We postulated a ` kinin-tensin system ' in which angiotensin II ( Ang II ) is cleaved by one or more serine protease independent of renin or angiotensin converting enzyme ( ACE ) .
OBJECTIVE	The aim was to determine whether this alternative Ang II-forming pathway by serine proteases participates in the rise in plasma levels of Ang II during exercise in humans .
METHODS	The study consisted of two double-blind crossover experiments .
METHODS	in experiment 1 six healthy volunteers who had been taking either placebo ( group P ) or the ACE inhibitor captopril ( 150 mg/day for 3 days ; group C ) performed a cycle ergometer graded exercise test at four different exercise intensities : stage 1 , half of the intensity at the blood lactate threshold ( WLT ) ; stage 2 , the intensity at WLT ; stage 3 , the intensity at 4 mmol/l blood lactate ; and stage 4 , an intensity between stage 3 and maximum intensity .
METHODS	In experiment 2 the same volunteers took captopril ( 150 mg/day for 3 days ) and performed exercise at an intensity corresponding to 90 % of the 4 mmol/l blood lactate intensity for 30 min during intravenous drip injection of a serine protease inhibitor , nafamostat [ NAF ; 0.2 mg/kg per h ; NAF ( + ) group ] or saline [ NAF ( - ) group ] .
RESULTS	In experiment 1 plasma Ang II levels increased from at rest to after exercise in both groups P and C. Although there was a significant treatment effect , captopril did not significantly alter the exercise-induced changes in Ang II level .
RESULTS	In experiment 2 the increase in Ang II level after 30 min exercise in the NAF ( + ) group was significantly lower than in the NAF ( - ) group .
CONCLUSIONS	These results suggest the presence of an alternative Ang II-forming pathway independent of ACE , and that one or more NAF-sensitive serine protease is responsible , at least partly , for generating Ang II during exercise .

###20931060
OBJECTIVE	To determine if educating caregivers in providing zinc supplements to infants < 6months old with acute diarrhoea is effective in treating diarrhoea and preventing acute lower respiratory infections ( ALRIs ) , and whether it leads to a decrease in the use of oral rehydration salts ( ORS ) .
METHODS	In this retrospective subgroup analysis of infants aged < 6months , six clusters were randomly assigned to intervention or control sites .
METHODS	Care providers were trained to give zinc and ORS to children with acute diarrhoea at intervention sites , and only ORS at control sites .
METHODS	Surveys were conducted at 3 and 6months to assess outcomes .
METHODS	Differences between intervention and control sites in episodes of diarrhoea and ALRI in the preceding 24 hours or 14 days and of hospitalizations in the preceding 3months were analysed by logistic regression .
RESULTS	Compared with control sites , intervention sites had lower rates of acute diarrhoea in the preceding 14 days at 3months ( odds ratio , OR : 0.60 ; 95 % confidence interval , CI : 0.43-0 .84 ) and 6months ( OR : 0.72 ; 95 % CI : 0.54-0 .94 ) ; lower rates of acute diarrhoea in the preceding 24 hours at 3months ( 0.66 ; 95 % CI : 0.50-0 .87 ) and of ALRI in the preceding 24 hours at 6months ( OR : 0.59 ; 95 % CI : 0.37-0 .93 ) ; and lower rates of hospitalization at 6months for all causes ( OR : 0.40 ; 95 % CI : 0.34-0 .49 ) , diarrhoea ( OR : 0.34 ; 0.18-0 .63 ) and pasli chalna or pneumonia ( OR : 0.36 ; 95 % CI : 0.24-0 .55 ) .
CONCLUSIONS	Educating caregivers in zinc supplementation and providing zinc to infants < 6months old can reduce diarrhoea and ALRI .
CONCLUSIONS	More studies are needed to confirm these findings as these data are from a subgroup analysis .

###22238398
BACKGROUND	Aging is associated with deteriorating glucose tolerance .
BACKGROUND	Studies assessing glucose tolerance and subsequent insulin and incretin hormone release often fail to take into account the rate of gastric emptying when evaluating these responses .
OBJECTIVE	Our objective was to determine the comparative effects of variations in the small intestinal glucose load on the glycemic , insulinemic , and incretin responses in healthy young and older subjects .
METHODS	Twelve healthy young ( six males , six females ; age 22.22.3 yr ) and 12 older ( six males , six females ; age 68.71.0 yr ) subjects had measurements of blood glucose , serum insulin and plasma incretin hormones [ glucagon-like peptide-1 ( GLP-1 ) and glucose-dependent insulinotropic polypeptide ( GIP ) ] and calculations of insulin resistance ( homeostatic model assessment ) and - cell function corrected for insulin sensitivity , before and during intraduodenal infusions of glucose at 1 , 2 , or 3 kcal/min or saline for 60 minutes .
METHODS	The study was double-blinded and randomized , and performed in the Discipline of Medicine at the Royal Adelaide Hospital .
RESULTS	At baseline , blood glucose and serum insulin were slightly higher in the older subjects ( P < 0.001 ) , whereas GLP-1 and GIP were comparable between groups .
RESULTS	In both groups , the glycemic , insulinemic , and GLP-1 responses were dependent on the duodenal glucose load in a nonlinear fashion ( P < 0.001 ) .
RESULTS	The glycemic response was greater ( P < 0.001 ) in the older subjects , whereas GLP-1 and GIP responses were comparable between groups .
RESULTS	The older subjects were more insulin resistant ( P < 0.001 ) and had impaired - cell function , particularly at higher glucose loads ( P < 0.05 ) .
CONCLUSIONS	When glucose is infused into the small intestine at equal rates in healthy young and older subjects , GLP-1 and GIP responses are comparable , indicating that impaired incretin secretion does not account for age-related glucose intolerance .

###9744693
OBJECTIVE	To compare modified Gianturco metal stents with plastic Atkinson tubes in the palliation of malignant dysphagia .
METHODS	Patient single-blind , multi-centre prospective , randomized trial .
METHODS	Three district general hospitals in the Wessex region .
METHODS	Thirty one consecutive patients with inoperable malignant oesophageal stenosis causing dysphagia and suitable for treatment with an endoprosthesis .
METHODS	Patients were randomized to receive either a modified Gianturco metal stent or a plastic Atkinson tube .
METHODS	Sedation was similar and patients were given identical dietary advice .
METHODS	Data were collected after insertion until the patients ' death .
METHODS	Procedural mortality/morbidity ; hospital stay ; weight loss ; quality of life ( Nottingham Health Profile , Spitzer QL index and specific questions about dysphagia and enjoyment of food ) ; duration of survival after insertion ; cost effectiveness of each intervention .
RESULTS	Overall complication rates were similar in the two groups .
RESULTS	Compared with Atkinson tubes , patients with Gianturco stents had better palliation of dysphagia ( median dysphagia score 1 vs 2 , P = 0.04 ) , maintained their weight longer ( median percent weight loss 0.66 vs 6.51 , P = 0.007 ) , enjoyed food more ( enjoyment score 2 vs 1 , P = 0.03 ) and survived longer ( log rank P < 0.025 ) .
RESULTS	Patients with metal stents were discharged from hospital earlier ( Gianturco 4 days , Atkinson 10 days , P = 0.001 ) , and initial treatment cost was lower if the cost of hospital stay exceeded pound sterling 120 per day .
CONCLUSIONS	Gianturco stents are superior to Atkinson tubes in the palliation of malignant oesophageal stenosis .

###16861094
BACKGROUND	After a course of IV proton pump inhibitor therapy , patients might require continued oral antisecretory therapy .
BACKGROUND	A direct comparison of therapeutic alternatives could assist physicians in decisions regarding optimal acid-suppressive therapy .
BACKGROUND	Oral esomeprazole might control intragastric acidity more effectively compared with other acid-suppressive agents after IV therapy .
OBJECTIVE	The aim of this study was to compare intragastric acid control on day 5 of administration of esomeprazole magnesium versus pantoprazole 40 mg PO QD after switching from 5 days of treatment with pantoprazole 40 mg IV in healthy volunteers .
METHODS	This randomized , open-label , comparative , 2-way crossover study was conducted at the Oklahoma Foundation for Digestive Research , Oklahoma City , Oklahoma , between October and December 2004 .
METHODS	Healthy , Helicobacter pylori-negative adults were randomly assigned to 1 of 2 dosing sequences : pantoprazole IV followed by esomeprazole PO or pantoprazole IV followed by pantoprazole PO .
METHODS	All study medications were administered for 5 days at a dose of 40 mg QD .
METHODS	IV pantoprazole was administered over 2 minutes ; all medications were administered 30 minutes before breakfast .
METHODS	There was a 10 - to 21-day washout period between each 10-day dosing period .
METHODS	All doses were administered at the study site .
METHODS	Before oral study drug administration on days 1 and 5 , 24-hour pH monitoring was performed using a pH catheter positioned 10 cm distal to the lower esophageal sphincter in the stomach .
METHODS	The primary end point was percentage of time with pH > 4 ( % t pH > 4 ) during the 24-hour pH-monitoring period .
METHODS	Tolerability was assessed using spontaneous reporting , laboratory analysis , and vital-sign measurement .
RESULTS	Of 42 subjects randomized to treatment sequences , 4 were withdrawn during the study because of invalid pH data ; 38 subjects ( 24 men , 14 women ; mean [ SD ] age , 25.2 [ 8.1 ] years ) had assessable data .
RESULTS	Day-5 % t pH > 4 was 68.5 % with esomeprazole and 53.3 % with pantoprazole ( P < 0.001 ) .
RESULTS	Day-1 % t pH > 4 was 62.5 % with esomeprazole and 51.0 % with pantoprazole ( P < 0.001 ) .
RESULTS	The most common adverse events were rhinitis ( 2 subjects each with pantoprazole IV and PO ; 1 subject with esomeprazole ) and headache ( 2 subjects with esomeprazole ; 1 subject with pantoprazole IV ) .
CONCLUSIONS	The results of this study in healthy adult volunteers suggest that switching from pantoprazole 40 mg IV to esomeprazole 40 mg PO QD more effectively suppresses intragastric acid compared with switching from pantoprazole 40 mg IV to pantoprazole 40 mg PO QD .
CONCLUSIONS	All 3 treatments were well tolerated .

###25885650
BACKGROUND	A small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma .
BACKGROUND	There is relatively little data , however , on the use of selective serotonin reuptake inhibitors ( SSRIs ) in this context .
METHODS	24 week , double-blind placebo controlled study .
METHODS	31 participants presenting immediately after trauma , and meeting diagnostic criteria for full or partial acute stress disorder were randomized to treatment with 10-20 mg of escitalopram or placebo daily for 24 weeks .
METHODS	2 participants were excluded from the analysis due to early drop out , leaving 29 participants ( escitalopram = 12 , placebo = 17 ) for inclusion in an intent - to - treat analysis .
METHODS	Participants were followed up until 56 weeks , and assessed with the Clinician Administered PTSD Scale ( CAPS ) .
METHODS	A mixed model repeated measures analysis of variance ( RMANOVA ) was undertaken to determine the efficacy of the intervention on the CAPS score .
RESULTS	There was a significant reduction in CAPS score over the course of treatment ( F ( 7 , 142 ) = 41.58 , p < 0.001 ) in both the escitalopram and placebo groups , with a greater reduction in CAPS score in the placebo group F ( 7 , 142 ) = 2.12 , p = 0.045 .
RESULTS	There were improvements on all secondary measures , including the Clinical Global Impressions scale , and scales assessing depression , anxiety and disability .
RESULTS	Only functional disability outcomes ( F ( 7 , 141 ) = 2.13 , p = .04 ) , were significantly different between treatment and placebo groups .
RESULTS	In the sample as a whole , improvement in scores were maintained at the 52 week follow-up .
RESULTS	Side effects were comparable between the groups .
CONCLUSIONS	These data are consistent with other recent work indicating that the SSRIs may not be efficacious in the prevention of PTSD .
CONCLUSIONS	Nevertheless , the small sample size and baseline differences between groups limit the explanatory power of the study .
CONCLUSIONS	Although a consideration of the possibility of medication prophylaxis in PTSD remains important , both from conceptual and clinical perspectives , caution is needed with regards to the use of SSRIs until their efficacy can be proven .
BACKGROUND	Clinical Trials NCT00300313 .

###21832112
BACKGROUND	Soybean oil-based lipid emulsions are the only Food and Drug Administration-approved lipid formulation for clinical use in parenteral nutrition ( PN ) .
BACKGROUND	Recently concerns with its use have been raised due to the proinflammatory effects that may lead to increased complications because they are rich in -6 polyunsaturated fatty acids .
METHODS	This was a prospective , randomized , controlled , crossover study comparing the vascular , metabolic , immune , and inflammatory effects of 24-h infusion of PN containing soybean oil-based lipid emulsion ( Intralipid ) , olive oil-based ( ClinOleic ) , lipid free , and normal saline in 12 healthy subjects .
RESULTS	Soybean oil-PN increased systolic blood pressure compared with olive oil-PN ( P < 0.05 ) .
RESULTS	Soybean oil PN reduced brachial artery flow-mediated dilatation from baseline ( -23 % at 4 h and -25 % at 24 h , both P < 0.01 ) ; in contrast , olive oil PN , lipid free PN , and saline did not change either systolic blood pressure or flow-mediated dilatation .
RESULTS	Compared with saline , soybean oil PN , olive oil PN , and lipid free PN similarly increased glucose and insulin concentrations during infusion ( P < 0.05 ) .
RESULTS	There were no significant changes in plasma free fatty acids , lipid profile , inflammatory and oxidative stress markers , immune function parameters , or sympathetic activity between soybean oil - and olive oil-based lipid emulsions .
CONCLUSIONS	The 24-h infusion of PN containing soybean oil-based lipid emulsion increased blood pressure and impaired endothelial function compared with PN containing olive oil-based lipid emulsion and lipid-free PN in healthy subjects .
CONCLUSIONS	These vascular changes may have significant implications in worsening outcome in subjects receiving nutrition support .
CONCLUSIONS	Randomized controlled trials with relevant clinical outcome measures are needed in patients receiving PN with olive oil-based and soybean oil-based lipid emulsions .

###22518819
BACKGROUND	To develop a positive aging phenotype , we undertook analyses to describe multiple dimensions of positive aging and their relationships to one another in women 65 years of age and older and evaluate the performance of individual indicators and composite factors of this phenotype as predictors of time to death , years of healthy living , and years of independent living .
METHODS	Data from Women 's Health Initiative clinical trial and observational study participants ages 65 years and older at baseline , including follow-up observations up to 8 years later , were analyzed using descriptive statistics and principal components analysis to identify the factor structure of a positive aging phenotype .
METHODS	The factors were used to predict time to death , years of healthy living ( without hospitalization or diagnosis of a serious health condition ) , and years of independent living ( without nursing home admission or use of special services ) .
RESULTS	We identified a multidimensional phenotype of positive aging that included two factors : Physical-Social Functioning and Emotional Functioning .
RESULTS	Both factors were predictive of each of the outcomes , but Physical-Social Functioning was the strongest predictor .
RESULTS	Each standard deviation of increase in Physical-Social Functioning was accompanied by a 23.7 % reduction in mortality risk , a 19.4 % reduction in risk of major health conditions or hospitalizations , and a 26.3 % reduction in risk of dependent living .
CONCLUSIONS	Physical-Social Functioning and Emotional Functioning constitute important components of a positive aging phenotype .
CONCLUSIONS	Physical-Social Functioning was the strongest predictor of outcomes related to positive aging , including years of healthy living , years of independent living , and time to mortality .

###11139103
OBJECTIVE	To compare fentanyl and sufentanil , administered in equipotent concentrations by target-controlled infusion , as components of a balanced anesthetic in patients undergoing coronary artery bypass graft ( CABG ) surgery .
METHODS	A prospective , randomized , double-blind trial .
METHODS	A university hospital .
METHODS	Twenty-one patients undergoing nonemergent , primary CABG surgery .
METHODS	Patients received fentanyl ( group F , n = 10 ) or sufentanil ( group S , n = 11 ) by target-controlled infusion throughout the pre-cardiopulmonary bypass ( CPB ) period .
METHODS	To ensure equipotency , the target effect-site concentrations employed ( fentanyl , 8.1 ng/mL , and sufentanil , 0.68 ng/mL ) were equal to the IC50 for electroencephalographic effect .
METHODS	Isoflurane was administered as needed to maintain pre-CPB hemodynamics near preoperative baseline values .
RESULTS	Hemodynamics and end-tidal isoflurane concentration were measured every 15 to 30 seconds .
RESULTS	Serum opioid concentrations were measured 5 times between induction and CPB .
RESULTS	Opioid cost was based on the number of ampules opened to provide the administered dose .
RESULTS	The 2 groups were similar demographically .
RESULTS	The pre-CPB serum opioid concentrations were constant and averaged fentanyl , 5.8 + / - 1.9 ng/mL , and sufentanil , 0.59 + / - 0.13 ng/mL .
RESULTS	Pre-CPB hemodynamics were stable and similar in both groups .
RESULTS	Pre-CPB end-tidal isoflurane requirements did not differ between groups and averaged 0.46 + / - 0.21 % in group F and 0.56 + / - 0.24 % in group S.
RESULTS	The duration of post-operative endotracheal intubation was 9.1 + / - 5.0 hours in group F and 8.0 + / - 3.2 hours in group S ( p = NS ) .
RESULTS	The cost per patient of fentanyl ( Canadian $ 6.12 + / - 1.04 ) was less than that of sufentanil ( Canadian $ 17.47 + / - 4.65 ) .
CONCLUSIONS	When administered in a constant 10:1 concentration ratio , fentanyl and sufentanil do not differ in their ability to facilitate pre-CPB hemodynamic control .
CONCLUSIONS	Although both opioids were relatively inexpensive , the acquisition cost of fentanyl was less than sufentanil .
CONCLUSIONS	A recommendation regarding the opioid of choice for routine use in patients undergoing CABG surgery awaits more rigorous studies of recovery and cost after equipotent doses of fentanyl and sufentanil .
CONCLUSIONS	When combined with isoflurane , effect-site opioid concentrations near the IC50 for electroencephalographic effect provide excellent pre-CPB hemodynamic control in patients undergoing CABG surgery .

###21353585
OBJECTIVE	Magnesium ( Mg ) is cardioprotective and has been routinely used to supplement cardioplegic solutions during coronary artery bypass graft ( CABG ) surgery .
OBJECTIVE	However , there is no consensus about the Mg concentration that should be used .
OBJECTIVE	The aim of this study was to compare the effects of intermittent antegrade warm-blood cardioplegia supplemented with either low - or high-concentration Mg .
METHODS	This study was a randomised controlled trial carried out in two cardiac surgery centres , Bristol , UK and Cuneo , Italy .
METHODS	Patients undergoing isolated CABG with cardiopulmonary bypass were eligible .
METHODS	Patients were randomised to receive warm-blood cardioplegia supplemented with 5 or 16 mmol l Mg .
METHODS	The primary outcome was postoperative atrial fibrillation .
METHODS	Secondary outcomes were serum biochemical markers ( troponin I , Mg , potassium , lactate and creatinine ) and time-to-plegia arrest .
METHODS	Intra-operative and postoperative clinical outcomes were also recorded .
RESULTS	Data from two centres for 691 patients ( 342 low and 349 high Mg ) were analysed .
RESULTS	Baseline characteristics were similar for both groups .
RESULTS	There was no significant difference in the frequency of postoperative atrial fibrillation in the high ( 32.8 % ) and low ( 32.0 % ) groups ( risk ratio 1.03 , 95 % confidence interval , CI , 0.82-1 .28 ) .
RESULTS	However , compared with the low group , troponin I release was 28 % less ( 95 % CI 55-94 % , p = 0.02 ) in the high-Mg group .
RESULTS	The 30-day mortality was 0.72 % ( n = 5 ) ; all deaths occurred in the high-Mg group but there was no significant difference between the groups ( p = 0.06 ) .
RESULTS	Frequencies of other major complications were similar in the two groups .
CONCLUSIONS	Warm-blood cardioplegia supplemented with 16 mmol l Mg , compared with 5 mmol l Mg , does not reduce the frequency of postoperative atrial fibrillation in patients undergoing CABG but may reduce cardiac injury .
CONCLUSIONS	( This trial was registered as ISRCTN95530505 . )

###22720738
BACKGROUND	The main hypothesis of this study is that patients having regular conventional haemodialysis ( HD ) will have a smaller decline in cardiac systolic function by using cooler dialysate .
BACKGROUND	Cooler dialysate may also be beneficial for brain function .
METHODS	The trial is a multicentre , prospective , randomised , un-blinded , controlled trial .
METHODS	Patients will be randomised 1:1 to use a dialysate temperature of 37C for 12months or an individualised cooled dialysate .
METHODS	The latter will be set at 0.5 C less than the patient 's own temperature , determined from the mean of 6 prior treatment sessions with a tympanic thermometer , up to a maximum of 36C .
METHODS	Protocol adherence will be regularly checked .
METHODS	Inclusion criteria are incident adult HD patients within 180days of commencing in-centre treatment 3 times per week with capacity to consent for the trial and without contra-indications for magnetic resonance imaging .
METHODS	Exclusion criteria include not meeting inclusion criteria , inability to tolerate magnetic resonance imaging and New York Heart Association Grade IV heart failure .
METHODS	During the study period , resting cardiac and cerebral magnetic resonance imaging will be performed at baseline and 12months on an inter-dialytic day .
METHODS	Cardiovascular performance during HD will also be assessed by continuous cardiac output monitors , intra-dialytic echocardiography and biomarkers at baseline and 12months .
METHODS	The primary outcome measure is a 5 % between-group difference in left ventricular ejection fraction measured by cardiac magnetic resonance imaging at 12months compared to baseline .
METHODS	Analysis will be by intention-to-treat .
METHODS	Secondary outcome measures will include changes in cerebral microstructure and changes in cardiovascular performance during HD .
METHODS	A total of 73 patients have been recruited into the trial from four UK centres .
METHODS	The trial is funded by a Research for Patient Benefit Grant from the National Institute of Healthcare Research .
METHODS	AO is funded by a British Heart Foundation Clinical Research Training Fellowship Grant .
METHODS	The funders had no role in the design of the study .
CONCLUSIONS	This investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysate temperature for preserving cardiac and cerebral function in HD patients .
BACKGROUND	ISRCTN00206012 and UKCRN ID 7422 .

###23220254
OBJECTIVE	Androgen Deprivation Therapy ( ADT ) for prostate cancer is associated with many treatment side effects that tend to erode couples ' intimacy .
OBJECTIVE	We piloted a randomized controlled trial to investigate the effect of an educational intervention designed to preserve couples ' intimacy in the face of ADT .
METHODS	Couples were recruited at the time the patient was first prescribed ADT and were randomized to a treatment or control group .
METHODS	Those in the treatment group were asked to read an educational guide and participate in an educational session designed to inform couples about possible ADT side effects and management strategies .
METHODS	To assess changes in the couples ' relationships , they were administered the Dyadic Adjustment Scale and the Personal Assessment of Intimacy in Relationships questionnaire prior to randomization and again at 6 months .
RESULTS	While results were not statistically significant , trends and effect sizes suggest that the educational intervention helped attenuate declines in intimacy for patients , but not for their partners .
RESULTS	Couples who participated in the intervention were more successful at maintaining sexual activity than were couples in the control group .
CONCLUSIONS	ADT places considerable strain on intimate relationships , particularly for the partners .
CONCLUSIONS	It appears that patients who receive help in anticipating and managing ADT related changes report better dyadic adjustment and closer intimacy .
CONCLUSIONS	More efforts are needed to develop interventions to benefit patients ' partners .
CONCLUSIONS	We conclude that the intervention holds promise and that a full-scale evaluation of the intervention is both feasible and warranted .

###21425736
OBJECTIVE	Assess the process and outcome of the treatment rehabilitation program in Thailand by comparing out-patients and in-patients from drug dependent treatment centers ( DDTCs ) under Matrix and FAST Models .
METHODS	In the DDTCs , male in-patient and out-patient volunteers aged 15-35 years were randomly selected to assess demographic characteristics , socio-economic status , history of substance use , and other behavior related to their health .
METHODS	Observations of the process of therapy and assessment of patients ' improvement were made .
METHODS	After completing the rehabilitation , which lasted four months , trained field workers visited the patients at 1 - , 3 - and 6-month intervals .
METHODS	Analyses of rehabilitation focused on cognitive and behavioral changes at one and three months .
METHODS	Regarding the follow-up outcomes , comparison of Matrix and FAST Models relapse was analyzed by survival graph and Cox-regression of the days since stopping illegal substance use .
RESULTS	Ninety-two in-patients and forty-three out-patients were recruited .
RESULTS	No significant difference was found in the characteristics of the patients between the two models or in the treatment centers .
RESULTS	After assessing patients at 1 - , 3 - , and 6-month , more improvement was noted among those in the FAST model than in the Matrix model .
CONCLUSIONS	This research confirmed improvement in attendees at the in-patient treatment model and the effectiveness of rehabilitation .

###14573316
BACKGROUND	Elevated cortisol levels might account for the reduction in central serotonin 1A ( 5-hydroxytryptamine [ 5-HT ] ( 1A ) ) receptor binding and function observed in patients with major depression .
BACKGROUND	We tested this hypothesis by studying the effect of acute administration of hydrocortisone on 5-HT ( 1A ) receptor binding potential ( BP ) in subjects recovered from depression .
METHODS	We studied 14 subjects ( 8 male , 6 female ) who had recovered from at least two episodes of major depression and had been euthymic and drug free for at least 6 months .
METHODS	Serotonin 1A receptor BP was measured by [ ( 11 ) C ] WAY-100635 in conjunction with positron emission tomography .
METHODS	Subjects were tested on two occasions in a double-blind , random-order , crossover design after administration of either hydrocortisone ( 100 mg orally ) or placebo 12 hours previously .
METHODS	Positron emission tomography scans were analyzed with a region of interest analysis .
RESULTS	Hydrocortisone treatment did not decrease 5-HT ( 1A ) receptor BP either in the hippocampus , which was our a priori hypothesis , or in other cortical 5-HT ( 1A ) regions ; however , female subjects had a higher 5-HT ( 1A ) receptor BP in certain brain areas compared with male subjects .
CONCLUSIONS	These data are consistent with an earlier study in healthy volunteers and do not support the proposal that decreased 5-HT ( 1A ) receptor BP in patients with acute major depression is a consequence of cortisol hypersecretion .

###22838225
OBJECTIVE	Local anesthesia by mandibular block or maxillary infiltration is commonly administered to children receiving dental treatment of primary molars .
OBJECTIVE	Discomfort , when presenting , most often involves the lower lip .
OBJECTIVE	The purpose of this study was to investigate whether children would be more opposed to attending a dental treatment following anesthesia by mandibular block than by maxillary infiltration .
METHODS	Each of 102 children in two age groups : 3 to 5 years , and 6 to 9 years , received the two types of local anesthesia at dental appointments one week apart .
METHODS	Their opposition to attending a subsequent appointment was assessed by parent report .
RESULTS	More adverse reactions were observed during and following anesthesia with mandibular block than with maxillary infiltration .
RESULTS	Few of the children in either age group expressed opposition to attend a dental visit after receiving mandibular block or maxillary infiltration in the previous visit .
CONCLUSIONS	Though more adverse reactions were observed in children following mandibular block than maxillary infiltration , this did not result in increased opposition to attend a subsequent dental appointment .

###19552750
OBJECTIVE	To examine the influence of a pharmaceutical care programme on disease control and health-related quality of life in Type 2 diabetes patients in the United Arab Emirates .
METHODS	A total of 240 Type 2 diabetes patients were recruited into a randomized , controlled , prospective clinical trial with a 12-month follow-up .
METHODS	A range of clinical measures , medication adherence and health-related quality of life ( Short Form 36 ) were evaluated at baseline and up to 12 months .
METHODS	Intervention group patients received pharmaceutical care from a clinical pharmacist , whereas control group patients received their usual care from medical and nursing staff .
METHODS	The primary outcome measure was change in HbA ( 1c ) .
METHODS	British National Formulary and Framingham scoring methods were used to estimate changes in 10-year coronary heart disease risk scores in all patients .
RESULTS	A total of 234 patients completed the study .
RESULTS	Significant reductions ( P < 0.001 ) in mean values ( baseline vs. 12 months ; 95 % confidence interval ) of HbA ( 1c ) [ 8.5 % ( 8.3 , 8.7 ) vs. 6.9 % ( 6.7 , 7.1 ) ] , systolic [ 131.4 mmHg ( 128.1 , 134.7 ) vs. 127.2 mmHg ( 124.4 , 130.1 ) ] and diastolic blood pressure [ 85.2 mmHg ( 83.5 , 86.8 ) vs. 76.3 mmHg ( 74.9 , 77.7 ) ] were observed in the intervention group ; no significant changes were noted in the control group .
RESULTS	The mean Framingham risk prediction score in the intervention group was 10.56 % ( 9.7 , 11.4 ) at baseline ; this decreased to 7.7 % ( 6.9 , 8.5 ) ( P < 0.001 ) at 12 months but remained unchanged in the control group .
CONCLUSIONS	The pharmaceutical care programme resulted in better glycaemic control and reduced cardiovascular risk scores in Type 2 diabetes patients over a 12-month period .

###24800383
BACKGROUND	The use of email and website as channels for workplace health information delivery is not fully explored .
BACKGROUND	This study aims to describe the rationale , design , and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors .
METHODS	Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention ( n = 174 ) or control group ( n = 165 ) .
METHODS	A website was developed for the intervention and educational modules were uploaded onto the website .
METHODS	The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none .
METHODS	Diet , lifestyle , anthropometric measurements , psychosocial factors and stages of change related to dietary fat , fruit and vegetable intake , and physical activity were assessed .
RESULTS	Participants were predominantly female and in non-academic positions .
RESULTS	Obesity was prevalent in 15 % and 37 % were at risk of co-morbidities .
RESULTS	Mean intake of fats was 31 % , fruit was -1 serving/day and vegetable was < 1 serving/day .
RESULTS	Less than 20 % smoked and drank alcohol and about 40 % were physically inactive .
RESULTS	The majority of the participants fell into the Preparation stage for decreasing fat intake , eating more fruit and vegetables , and increasing physical activity .
RESULTS	Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages .
CONCLUSIONS	Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention .
CONCLUSIONS	Hence the findings warrant the intervention planned .

###17046377
OBJECTIVE	This 12-month study was conducted to evaluate the skeletal effects of two monophasic oral contraceptives containing 20 mug of ethinylestradiol and 100 mug of levonorgestrel ( LEVO ) or 150 mug of desogestrel ( DESO ) .
METHODS	Fifty-two women ( 18-24 years ) were randomized into the DESO group or the LEVO group ; 36 women served as controls .
METHODS	The areal bone mineral density ( aBMD ) of the femoral neck and the lumbar spine was evaluated by DXA , and parameters of bone geometry and volumetric bone mineral density ( vBMD ) were assessed by peripheral quantitative computed tomography at the distal radius and the tibia .
RESULTS	The LEVO group did not lose vertebral aBMD , whereas women in the DESO group lost 1.5 % .
RESULTS	At the distal radius and the tibia ( shank level , 14 % ) , LEVO induced an increase in total cross-sectional area , indicating increased periosteal bone formation .
RESULTS	Radial trabecular vBMD declined by 1.4 + / -1.8 % in the DESO group , while it remained unchanged in the LEVO group .
CONCLUSIONS	Our study suggests that the skeletal effects of OC preparations may be influenced by progestogenic components in young women .

###19578819
BACKGROUND	There is consensus that patients should be told if they are injured by medical care .
BACKGROUND	However , there is little information on how they react to different methods of disclosure .
OBJECTIVE	To determine if volunteers ' reactions to videos of physicians disclosing adverse events are related to the physician apologizing and accepting responsibility .
METHODS	Survey of viewers randomized to watch videos of disclosures of three adverse events ( missed mammogram , chemotherapy overdose , delay in surgical therapy ) with designed variations in extent of apology ( full , non-specific , none ) and acceptance of responsibility ( full , none ) .
METHODS	Adult volunteer sample from the general community in Baltimore .
METHODS	Viewer evaluations of physicians in the videos using standardized scales .
RESULTS	Of 200 volunteers , 50 % were < 40 years , 25 % were female , 80 % were African American , and 50 % had completed high school .
RESULTS	For designed variations , scores were non-significantly higher for full apology/responsibility , and lower for no apology/no responsibility .
RESULTS	Perceived apology or responsibility was related to significantly higher ratings ( chi-square , 81 % vs. 38 % trusted ; 56 % vs. 27 % would refer , p < 0.05 ) , but inclination to sue was unchanged ( 43 % vs. 47 % ) .
RESULTS	In logistic regression analyses adjusting for age , gender , race and education , perceived apology and perceived responsibility were independently related to higher ratings for all measures .
RESULTS	Inclination to sue was reduced non-significantly .
CONCLUSIONS	Patients will probably respond more favorably to physicians who apologize and accept responsibility for medical errors than those who do not apologize or give ambiguous responses .
CONCLUSIONS	Patient perceptions of what is said may be more important than what is actually said .
CONCLUSIONS	Desire to sue may not be affected despite a full apology and acceptance of responsibility .

###10920469
BACKGROUND	To date , only 1 controlled study has found a drug ( haloperidol ) to be efficacious in augmenting response in patients with obsessive-compulsive disorder ( OCD ) refractory to serotonin reuptake inhibitor ( SRI ) monotherapy ; patients with comorbid chronic tic disorders showed a preferential response .
BACKGROUND	This report describes the first controlled study of risperidone addition in patients with OCD refractory to treatment with SRI alone .
METHODS	Seventy adult patients with a primary DSM-IV diagnosis of OCD received 12 weeks of treatment with an SRI .
METHODS	Thirty-six patients were refractory to the SRI and were randomized in a double-blind manner to 6 weeks of risperidone ( n = 20 ) or placebo ( n = 16 ) addition .
METHODS	Behavioral ratings , including the Yale-Brown Obsessive Compulsive Scale , were obtained at baseline and throughout the trial .
METHODS	Placebo-treated patients subsequently received an identical open-label trial of risperidone addition .
RESULTS	For study completers , 9 ( 50 % ) of 18 risperidone-treated patients were responders ( mean daily dose , 2.2 + / -0.7 mg/d ) compared with 0 of 15 in the placebo addition group ( P < .
RESULTS	005 ) .
RESULTS	Seven ( 50 % ) of 14 patients who received open-label risperidone addition responded .
RESULTS	Risperidone addition was superior to placebo in reducing OCD ( P < .001 ) , depressive ( P < .001 ) , and anxiety ( P = .003 ) symptoms .
RESULTS	There was no difference in response between OCD patients with and without comorbid diagnoses of chronic tic disorder or schizotypal personalty disorder .
RESULTS	Other than mild , transient sedation , risperidone was well tolerated .
CONCLUSIONS	These results suggest that OCD patients with and without comorbid chronic tic disorders or schizotypal personality disorder may respond to the addition of low-dose risperidone to ongoing SRI therapy .

###25907999
OBJECTIVE	To confirm the non-inferiority of the IOP-lowering effect of the 0.0015 % Tafluprost ophthalmic solution to the 0.005 % Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups .
METHODS	This study was conducted from August 2008 to December 2009 , at five clinical trial sites in China .
METHODS	Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015 % Tafluprost group or 0.005 % Latanoprost group.Intraocular pressure ( IOP ) measurement by Goldmann applanation tonometer , slit-lamp microscopy , Gonioscopy , Fundascopy , Visual acuity test , Perimetry , Blood pressure and pulse rate , Subjective symptoms were compered between two groups at Week 0 , Week 2 and Week 4 .
METHODS	For main effectiveness evaluation index adopt the bad effect evaluation , safety evaluation index by Fisher 's exact test probability method .
RESULTS	The 246 subjects/246 eyes were randomized ( Tafluprost group :122 subjects/122 eyes , Latanoprost group :124 subjects / 124 eyes ) .
RESULTS	Change in the IOP at 17:00 of Week 2 is ( 8.8 3.8 ) mmHg and ( 8.9 4.4 ) mmHg ( 1 mmHg = 0.133 kPa ) in Tafluprost group and Latanoprost group .
RESULTS	Percent change in the IOP at 17:00 of Week 2 is ( 33.2 12.8 ) % and ( 34.4 14.1 ) % in Tafluprost group and Latanoprost group .
RESULTS	Change in the IOP at 17:00 at the end of treatment is ( 9.8 4.0 ) mmHg and ( 9.2 4.1 ) mmHg in Tafluprost group and Latanoprost group .
RESULTS	Percent change in the IOP at 17:00 at the end of treatment is 37.2 % 13.4 % group and 35.7 % 13.0 % in Tafluprost and Latanoprost group.In addition , distribution of subjects with percentage decrease of IOP > 30 % was 72.5 % in Tafluprost group higher than 63.8 % in Latanoprost group .
RESULTS	The major adverse reactions were conjunctival hyperemia , eye irritation , eye pain and foreign body sensation .
RESULTS	The incidence of adverse reactions is 31.7 % in Tafluprost group and 20.8 % in Latanoprost group .
RESULTS	The inter-group difference had no statistical significance .
CONCLUSIONS	Efficacy and safety of Tafluprost ophthalmic solution are no less than Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension .

###18523642
OBJECTIVE	To develop and evaluate the effectiveness of a home based intervention in reducing caregiver burden , promoting caregiver mental health and reducing behavioural problems in elderly persons with dementia .
RESULTS	This was a randomised controlled trial in which the person with dementia-caregiver dyad was randomly allocated either to receive the intervention immediately or to a waiting list group which received the intervention after 6 months .
RESULTS	It was carried out in communities based in two talukas ( administrative blocks ) in Goa , India .
RESULTS	Mild to moderate cases with dementia ( diagnosed using the DSM IV criteria and graded using the Clinical Dementia Rating scale ) and their caregivers were included in the trial .
RESULTS	Community based intervention provided by a team consisting of Home Care Advisors who were supervised by a counselor and a psychiatrist , focusing on supporting the caregiver through information on dementia , guidance on behaviour management , a single psychiatric assessment and psychotropic medication if needed .
RESULTS	We measured caregiver mental health ( General Health Questionnaire ) , caregiver burden ( Zarit Burden Score ) , distress due to behavioural disturbances ( NPI-D ) , behavioural problems in the subject ( NPI-S ) and activities of daily living in the elder with dementia ( EASI ) .
RESULTS	Outcome evaluations were masked to the allocation status .
RESULTS	We analysed each outcome with a mixed effects model .
RESULTS	81 families enrolled in the trial ; 41 were randomly allocated to the intervention .
RESULTS	59 completed the trial and 18 died during the trial .
RESULTS	The intervention led to a significant reduction of GHQ ( -1.12 , 95 % CI -2.07 to -0.17 ) and NPI-D scores ( -1.96 , 95 % CI -3.51 to -0.41 ) and non-significant reductions in the ZBS , EASI and NPI-S scores .
RESULTS	We also observed a non-significant reduction in the total number of deaths in people with dementia in the intervention arm ( OR 0.34 , 95 % CI 0.01 to 1.03 ) .
CONCLUSIONS	Home based support for caregivers of persons with dementia , which emphasizes the use of locally available , low-cost human resources , is feasible , acceptable and leads to significant improvements in caregiver mental health and burden of caring .
CONCLUSIONS	ClinicalTrials.gov NCT00479271 .

###23941474
BACKGROUND	Data on therapeutic interventions following deliberate self harm ( DSH ) in patients with treatment-resistant depression ( TRD ) are very scant and there is no unanimous consensus on the best pharmacological option for these patients .
BACKGROUND	There is some evidence that lithium treatment might be effective in reducing the risk of completed suicide in adult patients with unipolar affective disorders , however no clear cut results have been found so far .
BACKGROUND	The primary aim of the present study is to assess whether adding lithium to standard therapy is an effective treatment strategy to reduce the risk of suicidal behaviour in long term treatment of people with TRD and previous history of DSH .
METHODS	We will carry out a randomised , parallel group , assessor-blinded superiority clinical trial .
METHODS	Adults with a diagnosis of major depression , an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode will be allocated to add lithium to current therapy ( intervention arm ) or not ( control arm ) .
METHODS	Following randomisation , treatment is to be taken daily for 1 year unless some clear reason to stop develops .
METHODS	Suicide completion and acts of DSH during the 12 months of follow-up will constitute the composite primary outcome .
METHODS	To preserve outcome assessor blindness , an independent adjudicating committee , blind to treatment allocation , will anonymously review all outcome events .
CONCLUSIONS	The results of this study should indicate whether lithium treatment is associated with lower risk of completed suicide and DSH in adult patients with treatment resistant unipolar depression , who recently attempted suicide .
BACKGROUND	ClinicalTrials.gov identifier : NCT00927550 .

###18768106
OBJECTIVE	This study compares once-daily ropinirole 24-h prolonged release and three-times-daily ropinirole immediate release in patients with early Parkinson 's disease .
METHODS	This multicentre , double-blind , non-inferiority crossover study involved 161 patients randomized to one of four formulation sequences : ( 1 ) immediate release-immediate release-prolonged release ; ( 2 ) immediate release-prolonged release-prolonged release ; ( 3 ) prolonged release-prolonged release-immediate release ; ( 4 ) prolonged release-immediate release-immediate release .
METHODS	During a 12-week dose-titration period , ropinirole immediate release was titrated according to the approved labelling ; titration of ropinirole 24-h prolonged release started at a higher dose and was more rapid .
METHODS	Patients then entered three consecutive , flexible-dose , 8-week maintenance periods .
METHODS	At the end of the first maintenance period , half of the patients in each formulation group switched to the same or closest dose of the alternative formulation ; remaining patients switched at the end of the second maintenance period .
RESULTS	At the end of titration , before the first dose switch , there were substantial reductions in mean Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor scores .
RESULTS	During maintenance periods , both groups showed similar efficacy on the UPDRS motor score .
RESULTS	Overall mean ( standard error ) change from period baseline was -0.1 ( 0.28 ) for ropinirole 24-h prolonged release , and 0.6 ( 0.30 ) for ropinirole immediate release ( adjusted mean treatment difference -0.7 ; 95 % confidence interval [ CI ] : -1.51 , 0.10 ; p = 0.0842 ) .
RESULTS	The upper limit of the 95 % CI was less than the predefined threshold of 3 points for non-inferiority .
RESULTS	Ropinirole 24-h prolonged release was well-tolerated when titrated more rapidly than ropinirole immediate release ; overnight switching between formulations was also well-tolerated .
RESULTS	Study limitations included complexity of the non-inferiority study design and the forced dose-titration schedule .
CONCLUSIONS	Ropinirole 24-h prolonged release was effective and well-tolerated in patients with early Parkinson 's disease .

###20732868
OBJECTIVE	Although dyspnoea is the most common cause of admission for acute heart failure ( AHF ) , more needs to be known about its clinical course and prognostic significance .
RESULTS	The Pre-RELAX-AHF study randomized 232 subjects with AHF to placebo or four doses of relaxin and evaluated early ( 6-24 h Likert scale ) and persistent [ change in visual analogue scale area under the curve ( VAS AUC ) through Day 5 ] dyspnoea relief .
RESULTS	Worsening heart failure ( WHF ) was defined as worsening AHF signs and symptoms requiring additional therapy .
RESULTS	Patients were followed until Day 180 .
RESULTS	Early dyspnoea relief was observed in only 25 % of all patients , and VAS AUC at 5 days was 45 % over baseline values in all patients ( 32 % placebo ; 50 % all relaxin-treated patients ) .
RESULTS	Worsening heart failure to Day 5 was observed in 16 % of all patients ( 21 % placebo ; 14 % relaxin ) .
RESULTS	Lack of persistent dyspnoea relief and WHF were associated with a longer length of initial hospital stay and worse 60-day outcomes .
CONCLUSIONS	Dyspnoea relief in patients admitted with AHF is often incomplete , and many may show WHF after the initial stabilization .
CONCLUSIONS	Both lack of persistent dyspnoea relief and in-hospital WHF predict a longer length of stay and worse outcome .

###18374405
BACKGROUND	Grass pollen immunotherapy is an effective treatment for seasonal allergic rhinitis that provides the opportunity to study the induction and maintenance of allergen-specific immune tolerance .
OBJECTIVE	We investigated the relationship between clinical responsiveness , regulatory cytokine production , and antibody responses to allergen during 1 year of immunotherapy .
METHODS	Eighteen subjects with severe seasonal allergic rhinitis were randomized double-blind to receive active or placebo injections of an alum-adsorbed grass pollen vaccine ( Alutard SQ ) .
METHODS	Subjects underwent repeated testing of early - and late-phase skin responses to intradermal allergen , and cellular responses to grass pollen allergen were tested .
METHODS	Sera were tested for allergen-specific IgG4 , IgA , and inhibitory activity in biologic assays of IgE responses .
RESULTS	Grass pollen immunotherapy was effective in reducing overall symptom scores ( P < .05 ) and conjunctival reactivity ( P < .05 ) .
RESULTS	In the active group significant IL-10 production occurred early at low allergen doses and at a similar time as inhibition of late skin responses at 2 to 4 weeks .
RESULTS	Serum allergen-specific IgG4 , IgA , and inhibitory antibody activity for basophil histamine release and IgE-facilitated allergen binding to B cells occurred later , at 6 to 12 weeks , at higher allergen doses and preceded inhibition of early skin responses .
CONCLUSIONS	IL-10 responses occur early but at immunotherapy doses that are not clinically effective .
CONCLUSIONS	Later induction of inhibitory antibodies , including IgG4 and IgA , might be required for efficacy through modulation of IgE-mediated events .

###24667180
BACKGROUND	Palliative care patients and their family caregivers may have a foreshortened perspective of the time left to live , or the expectation of the patient 's death in the near future .
BACKGROUND	Patients and caregivers may report distress in physical , psychological , or existential/spiritual realms .
OBJECTIVE	To conduct a randomized controlled trial examining the effectiveness of retired senior volunteers ( RSVs ) in delivering a reminiscence and creative activity intervention aimed at alleviating palliative care patient and caregiver distress .
METHODS	Of the 45 dyads that completed baseline assessments , 28 completed postintervention and 24 completed follow-up assessments .
METHODS	The intervention group received three home visits by RSVs ; control group families received three supportive telephone calls by the research staff .
METHODS	Measures included symptom assessment and associated burden , depression , religiousness/spirituality , and meaning in life .
RESULTS	Patients in the intervention group reported a significantly greater reduction in frequency of emotional symptoms ( P = 0.02 ) and emotional symptom bother ( P = 0.04 ) than the control group , as well as improved spiritual functioning .
RESULTS	Family caregivers in the intervention group were more likely than control caregivers to endorse items on the Meaning of Life Scale ( P = 0.02 ) .
RESULTS	Only improvement in intervention patients ' emotional symptom bother maintained at follow-up after discontinuing RSV contact ( P = 0.024 ) .
CONCLUSIONS	Delivery of the intervention by RSVs had a positive impact on palliative care patients ' emotional symptoms and burden and caregivers ' meaning in life .
CONCLUSIONS	Meaningful prolonged engagement with palliative care patients and caregivers , possibly through alternative modes of treatment delivery such as continued RSV contact , may be necessary for maintenance of therapeutic effects .

###18347003
OBJECTIVE	This study evaluated the effect of mentalization-based treatment by partial hospitalization compared to treatment as usual for borderline personality disorder 8 years after entry into a randomized , controlled trial and 5 years after all mentalization-based treatment was complete .
METHODS	Interviewing was by research psychologists blind to original group allocation and structured review of medical notes of 41 patients from the original trial .
METHODS	Multivariate analysis of variance , chi-square , univariate analysis of variance , and nonparametric Mann-Whitney statistics were used to contrast the two groups depending on the distribution of the data .
RESULTS	Five years after discharge from mentalization-based treatment , the mentalization-based treatment by partial hospitalization group continued to show clinical and statistical superiority to treatment as usual on suicidality ( 23 % versus 74 % ) , diagnostic status ( 13 % versus 87 % ) , service use ( 2 years versus 3.5 years of psychiatric outpatient treatment ) , use of medication ( 0.02 versus 1.90 years taking three or more medications ) , global function above 60 ( 45 % versus 10 % ) , and vocational status ( employed or in education 3.2 years versus 1.2 years ) .
CONCLUSIONS	Patients with 18 months of mentalization-based treatment by partial hospitalization followed by 18 months of maintenance mentalizing group therapy remain better than those receiving treatment as usual , but their general social function remains impaired .

###20878265
BACKGROUND	Refractory status epilepticus ( RSE ) has a mortality of 16-39 % ; coma induction is advocated for its management , but no comparative study has been performed .
BACKGROUND	We aimed to assess the effectiveness ( RSE control , adverse events ) of the first course of propofol versus barbiturates in the treatment of RSE .
METHODS	In this randomized , single blind , multi-center trial studying adults with RSE not due to cerebral anoxia , medications were titrated toward EEG burst-suppression for 36-48 h and then progressively weaned .
METHODS	The primary endpoint was the proportion of patients with RSE controlled after a first course of study medication ; secondary endpoints included tolerability measures .
RESULTS	The trial was terminated after 3 years , with only 24 patients recruited of the 150 needed ; 14 subjects received propofol , 9 barbiturates .
RESULTS	The primary endpoint was reached in 43 % in the propofol versus 22 % in the barbiturates arm ( P = 0.40 ) .
RESULTS	Mortality ( 43 vs. 34 % ; P = 1.00 ) and return to baseline clinical conditions at 3 months ( 36 vs. 44 % ; P = 1.00 ) were similar .
RESULTS	While infections and arterial hypotension did not differ between groups , barbiturate use was associated with a significantly longer mechanical ventilation ( P = 0.03 ) .
RESULTS	A non-fatal propofol infusion syndrome was detected in one patient , while one subject died of bowel ischemia after barbiturates .
CONCLUSIONS	Although undersampled , this trial shows significantly longer mechanical ventilation with barbiturates and the occurrence of severe treatment-related complications in both arms .
CONCLUSIONS	We describe practical issues necessary for the success of future studies needed to improve the current unsatisfactory state of evidence .

###20021654
BACKGROUND	Multiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity .
BACKGROUND	In the past decades the number of multiple pregnancies has increased .
BACKGROUND	This trend is partly due to the fact that women start family planning at an increased age , but also due to the increased use of ART.Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation ( IUI COH ) .
BACKGROUND	The cumulative pregnancy rate is 40 % , with a 10 % multiple pregnancy rate.This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer ( IVF e SET ) or Modified Natural Cycle IVF ( MNC IVF ) can reduce the number of multiple pregnancy rates , but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility .
BACKGROUND	Secondly , the aim is to perform a cost effective analyses and assess treatment preference of these couples .
METHODS	We plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle ( MNC ) IVF or three cycles with IVF-elective Single Embryo Transfer ( eSET ) plus cryo-cycles within a time frame of 12 months.Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included .
METHODS	Women with anovulatory cycles , severe endometriosis , double sided tubal pathology or serious endocrine illness will be excluded.Our primary outcome is the birth of a healthy singleton .
METHODS	Secondary outcomes are multiple pregnancy , treatment costs , and patient experiences in each treatment arm .
METHODS	The analysis will be performed according tot the intention to treat principle .
METHODS	We will test for non-inferiority of the three arms with respect to live birth .
METHODS	As we accept a 12.5 % loss in pregnancy rate in one of the two IVF arms to prevent multiple pregnancies , we need 200 couples per arm ( 600 couples in total ) .
CONCLUSIONS	Determining the safest and most cost-effective treatment will ensure optimal chances of pregnancy for subfertile couples with substantially diminished perinatal and maternal complications .
CONCLUSIONS	Should patients find the most cost-effective treatment acceptable or even preferable , this could imply the need for a world wide shift in the primary treatment .
BACKGROUND	Current Controlled Trials ISRCTN 52843371 .

###20822968
BACKGROUND	Diabetes confers an increased risk for cardiovascular effects of airborne particles .
OBJECTIVE	We hypothesized that inhalation of elemental carbon ultrafine particles ( UFP ) would activate blood platelets and vascular endothelium in people with type 2 diabetes .
METHODS	In a randomized , double-blind , crossover trial , 19 subjects with type 2 diabetes inhaled filtered air or 50 g/m elemental carbon UFP ( count median diameter , 32 nm ) by mouthpiece for 2 hr at rest .
METHODS	We repeatedly measured markers of vascular activation , coagulation , and systemic inflammation before and after exposure .
RESULTS	Compared with air , particle exposure increased platelet expression of CD40 ligand ( CD40L ) and the number of platelet-leukocyte conjugates 3.5 hr after exposure .
RESULTS	Soluble CD40L decreased with UFP exposure .
RESULTS	Plasma von Willebrand factor increased immediately after exposure .
RESULTS	There were no effects of particles on plasma tissue factor , coagulation factors VII or IX , or D-dimer .
CONCLUSIONS	Inhalation of elemental carbon UFP for 2-hr transiently activated platelets , and possibly the vascular endothelium , in people with type 2 diabetes .

###18622283
BACKGROUND	The determination of optimal tacrolimus ( TAC ) trough levels is needed to prevent adverse effects of calcineurin inhibitors .
METHODS	Stable transplant recipients currently receiving cyclosporine ( CsA ) were assigned randomly ( 1:1:1 ) to continue CsA ( target trough level of 50-250 ng/mL ) ; or convert to `` reduced '' TAC ( target trough level 3.0-5 .9 ng/mL ) or `` standard '' TAC ( target trough level 6.0-8 .9 ng/mL ) .
RESULTS	At 12 months , there was a significant improvement in renal function in the reduced TAC versus CsA group with lower serum creatinine ( P = 0.004 ) and cystatin C ( P < 0.001 ) , and higher estimated creatinine clearance ( P = 0.017 ) .
RESULTS	However , there were no statistically significant differences in any renal parameter in the standard TAC versus CsA group .
RESULTS	Total and low-density lipoprotein cholesterol were significantly reduced in both TAC groups versus the CsA group ( P < 0.001 ) .
RESULTS	Patient and graft survival and episodes of biopsy-confirmed acute rejection were similar for all treatment groups , and no statistically significant differences were observed between groups in the incidence of new-onset diabetes or cardiac conditions , or in the prevalence of hyperglycemia , hypertension , or hyperlipidemia among patients who did not have these conditions at baseline .
RESULTS	Alopecia developed more commonly among TAC-treated patients than CsA-treated patients ( P < 0.001 ) .
CONCLUSIONS	Compared with CsA continuation , conversion to reduced TAC target trough concentrations resulted in significantly improved renal function without increasing the risk of rejection .
CONCLUSIONS	Conversion to TAC , regardless of target concentration , resulted in improved serum lipid profiles in kidney transplant recipients at 12 months .

###17236889
OBJECTIVE	To evaluate the efficacy , tolerability , and blood pressure ( BP ) lowering effect of extended release metoprolol succinate ( ER metoprolol ) in children 6 to 16 years of age with established hypertension .
METHODS	Patients were randomized to one of four treatment arms : placebo or ER metoprolol ( 0.2 mg/kg , 1.0 mg/kg , or 2.0 mg/kg ) .
METHODS	Data were analyzed on 140 intent-to-treat patients .
RESULTS	Mean age ( + / - SD ) was 12.5 + / - 2.8 years and mean baseline BP was 132/78 + / - 9/9 mmHg .
RESULTS	Following 4 weeks of treatment , mean changes in sitting BP were : placebo = -1.9 / -2.1 mmHg ; ER metoprolol 0.2 mg/kg = -5.2 / -3.1 mmHg ; 1.0 mg/kg = -7.7 / -4.9 mmHg ; 2.0 mg/kg = -6.3 / -7.5 mmHg .
RESULTS	Compared with placebo , ER metoprolol significantly reduced systolic blood pressure ( SBP ) at the 1.0 and 2.0 mg/kg dose ( P = .027 and P = .049 , respectively ) , reduced diastolic blood pressure ( DBP ) at the 2.0 mg/kg dose ( P = .017 ) , and showed a statistically significant dose response relationship for the placebo-corrected change in DBP from baseline .
RESULTS	There were no serious adverse events or adverse events requiring study drug discontinuation among patients receiving active therapy .
CONCLUSIONS	These data indicate that ER metoprolol is an effective and well-tolerated treatment for hypertension in children .

###25293975
BACKGROUND	In Denmark , guidelines on low back pain management are currently being implemented ; in association with this , a clinical trial is conducted .
BACKGROUND	A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners ' adherence to the guidelines .
BACKGROUND	In addition to usual dissemination , the extended implementation strategy is composed of visits from a guideline facilitator , stratification tools , and feedback on guideline adherence .
BACKGROUND	The aim of this paper is to provide the considerations on the design of the health economic evaluation .
METHODS	The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region .
METHODS	An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled .
METHODS	The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis .
METHODS	Effectiveness measures include referral to secondary care , health-related quality of life measured by EQ-5D-5L , and disability measured by the Roland Morris disability questionnaire .
METHODS	Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation .
METHODS	The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon .
CONCLUSIONS	It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care .
CONCLUSIONS	It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes , thereby rendering the extended implementation strategy cost-effective .
BACKGROUND	ClinicalTrials.gov : NCT01699256 .

###16716604
BACKGROUND	In the assessment of potential new treatments for Type 2 diabetes , robust pharmacological methods are helpful in assessing efficacy , defining dose response , duration of effect and ultimately in deciding whether to progress compounds to the next phase of drug development .
BACKGROUND	Hepatic glucose handling is abnormal in Type 2 diabetes .
BACKGROUND	We evaluated glucagon challenge as a way of assessing effects on the glycogenolytic pathway .
METHODS	In each of 2 studies healthy subjects received glucagon as an IV bolus of 0.5 mg studied after an overnight fast and plasma glucose was monitored before and for 180 min after glucagon challenge .
METHODS	Study 1 was a double-blind placebo controlled study comparing glucagon administered twice with saline placebo .
METHODS	In study 2 , subjects were studied on a single occasion and the glucagon challenge was carried out in the morning and then repeated 7 h later .
METHODS	In study 2 , insulin concentrations were also monitored before and after the glucagon challenge .
RESULTS	In study 1 , glucose rose in a reproducible manner with a peak glucose 20 min after challenge falling to baseline values by 120 min and then fell below values for saline challenge between 120 and 180 min .
RESULTS	Analysis of the data showed that the corrected AUC ( 0-20 ) min was the most robust variable and could be expected to detect clinically relevant changes in small numbers ( < 10 ) of subjects .
RESULTS	In study 2 , we demonstrated that when glucagon challenge was repeated 7 h after the first challenge , the glucose excursion was highly variable .
RESULTS	The plasma insulin response was robust following the initial challenge but variable following the second challenge .
CONCLUSIONS	We have demonstrated that an IV bolus glucagon challenge ( 0.5 mg ) results in a reproducible rise in glucose in healthy volunteers and can be repeated within a week but when repeated on the same day gave a poorly reproducible rise in glucose .
CONCLUSIONS	Glucagon challenge may be useful in studying novel drugs that affect glycogen handling in the liver .

###10549683
BACKGROUND	Depressed individuals effectively treated with selective serotonin reuptake inhibitors ( SSRIs ) often report persistent insomnia and require adjunctive sleep-promoting therapy .
METHODS	Men ( N = 40 ) and women ( N = 150 ) with a mean age of 41.6 years who had persistent insomnia in the presence of effective and stable treatment ( at least 2 weeks ) with fluoxetine ( < or = 40 mg/day ) , sertraline ( < or = 100 mg/day ) , or paroxetine ( < or = 40 mg/day ) for DSM-IV major depressive disorder , dysthymic disorder , or minor depressive disorder of mild-to-moderate severity ( and score of < or = 2 on item 3 of the Hamilton Rating Scale for Depression [ HAM-D ] ) participated in this randomized , double-blind , parallel-group study .
METHODS	At study entry , patients were required to score < or = 12 on the HAM-D .
METHODS	During a 1-week single-blind placebo period , patients had to report on at least 3 nights a latency of > or = 30 minutes or a sleep time of < 6.5 hours and clinically significant daytime impairment .
METHODS	Patients received either placebo ( N = 96 ) or zolpidem , 10 mg ( N = 94 ) nightly , for 4 weeks and single-blind placebo for 1 week thereafter .
METHODS	Sleep was measured with daily questionnaires and during weekly physician visits .
RESULTS	Compared with placebo , zolpidem was associated with improved sleep : longer sleep times ( weeks 1 through 4 , p < .05 ) , greater sleep quality ( weeks 1 through 4 , p < .01 ) , and reduced number of awakenings ( weeks 1 , 2 , and 4 ; p < .05 ) , together with feeling significantly more refreshed , less sleepy , and more able to concentrate .
RESULTS	After placebo substitution , the zolpidem group showed significant worsening relative to pretreatment sleep on the first posttreatment night in total sleep time and sleep quality , reverted to pretreatment insomnia levels on the other hypnotic efficacy measures , or maintained improvement ( fewer number of awakenings ) .
RESULTS	There was no evidence of dependence or withdrawal from zolpidem ( DSM-IV criteria ) .
RESULTS	Incidence rates of adverse events were similar in both treatment groups ( 74 % and 83 % for placebo and zolpidem , respectively ) , but 7 zolpidem patients discontinued compared with 2 placebo patients .
CONCLUSIONS	In this defined patient population , zolpidem , 10 mg , was effectively and safely co-administered with an SSRI , resulting in improved self-rated sleep , daytime functioning , and well-being .

###22253016
OBJECTIVE	Is the severity of acute oral mucositis in patients who receive postoperative intensity-modulated radiotherapy ( PO-IMRT ) for oral tongue squamous cell carcinoma ( SCC ) reduced by sparing the oral mucosa outside of the planning target volume ( PTV ) ?
METHODS	Prospective , randomized trial .
METHODS	Forty-eight patients with oral tongue SCC who received PO-IMRT at our institution were randomized to two groups : the oral-sparing ( OR-SP ) group and oral-unsparing ( OR-USP ) group .
METHODS	For the OR-SP group ( n = 24 ) , the oral mucosa outside of the PTV was spared .
METHODS	Furthermore , the mucosa including the bilateral cheeks , upper lip , and lower lip was defined as the united site and given < 32 Gy .
METHODS	For the OR-USP group ( n = 24 ) , none of the oral mucosa was protected .
METHODS	The severity of clinical acute mucositis in each patient was assessed weekly during PO-IMRT until completely healed .
METHODS	Oral mucositis was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 .
METHODS	Dosimetry and therapeutic measures related to acute mucositis between the two groups were compared .
RESULTS	During PO-IMRT , no patient experienced grade 4 + acute mucositis in any oral site .
RESULTS	Compared to the OR-USP group , there was less grade 2 and 3 mucositis in the united site of the OR-SP group ( 0 % and 25 % vs. 45.8 % and 54.2 % , respectively ; P = .000 ) .
RESULTS	Also , the mean dose to the united site was significantly lower with OR-SP compared to OR-USP ( 41.8 7.4 Gy vs. 58.8 2.2 Gy ; P = .000 ) .
RESULTS	The OR-SP group was associated with significant reductions in the use of analgesics ( P = .043 ) and intravenous antibiotics ( P = .039 ) .
RESULTS	No recurrences were detected in the vicinity of the spared oral mucosa ( the united site ) during a median follow-up time of 30 months .
CONCLUSIONS	OR-SP PO-IMRT for patients with oral tongue SCC resulted in a significant decrease in the severity of acute mucositis and improved quality of life .
CONCLUSIONS	The sparing of the oral mucosa outside of the PTV is safe and does not compromise oncologic outcomes .

###23356388
OBJECTIVE	To investigate conversations between nurses and parents in Swedish child health services and to assess to what extent attention is directed towards dietary and physical activity behaviours in children .
METHODS	Twenty-three nurses audio-recorded one session each .
METHODS	Recordings were assessed and topics were classified according to predetermined categories .
RESULTS	The three most frequent topics of conversation concerned physical examinations of the child ( 30 % of session time ) , talking to the child to establish or maintain contact and interest ( 15 % ) , and development of language skills ( 12 % ) .
RESULTS	Dietary habits came on fourth place ( 10 % ) , and physical activity ranked 14 ( 4 % ) .
CONCLUSIONS	Attention to dietary and physical activity behaviours in children is infrequent in Swedish child health services .
CONCLUSIONS	Concern is raised about the efficacy of prevention efforts against childhood obesity .

###9241284
OBJECTIVE	To determine the effect of third-trimester calcium supplementation on maternal hemodynamic function .
METHODS	Pregnant women were randomized to receive either 1.5 g of elemental calcium or placebo for 6 weeks during the third trimester .
METHODS	Using Doppler technique , maternal hemodynamic characteristics were measured at baseline , at 2 hours after the first dose of study drug , and at the completion of 6 weeks .
METHODS	Serum , dietary , and urinary calcium levels were also assessed .
METHODS	Power calculation indicated the need to study ten subjects in each group to detect a 1.2 L ( 20 % ) difference in cardiac output between groups , assuming a mean of 6.2 + / - 1.0 L/minute .
METHODS	Data were analyzed by analysis of variance for repeated measures , Student t test , Mann-Whitney U test , and Fisher exact test .
RESULTS	Twenty-three women enrolled , and 18 completed the study .
RESULTS	There were no statistically significant differences in demographic characteristics or in serum , dietary , or urinary calcium levels between the two groups .
RESULTS	There were also no statistically significant differences in hemodynamic function over time within the calcium supplementation or placebo group ( P > .05 ; analysis of variance for repeated measures ) .
RESULTS	After 6 weeks , there were no significant differences between the calcium - and placebo-treated subjects in any hemodynamic measurement .
RESULTS	Specifically , there was not a statistically significant difference in cardiac output ( 7.3 + / - 1.2 L/minute versus 8.0 + / - 0.9 L/minute ; P = .09 ) between the calcium - and placebo-treated groups .
CONCLUSIONS	These findings suggest that third-trimester calcium supplementation does not significantly alter cardiac output .
CONCLUSIONS	The mechanism by which calcium supplementation lowers blood pressure remains to be elucidated .

###10886272
BACKGROUND	A number of drugs have been used to prevent aging changes .
BACKGROUND	However , studies of oral isotretinoin , the commonly used acne drug , as an antiaging drug are lacking .
OBJECTIVE	To determine improvement in cutaneous aging utilizing oral isotretinoin combined with different procedures of facial rejuvenation .
METHODS	Sixty patients ranging in age from 35 to 65 years , in whom additional modalities of rejuvenation were also used , were randomly assigned to receive treatment with oral isotretinoin ( 10-20 mg three times a week for 2 months , group A ) .
METHODS	Their results were compared with 60 patients who had undergone the same surgical procedures but with no oral isotretinoin ( group B ) .
RESULTS	All patients treated with oral isotretinoin noted improvement in wrinkles , thickness and color of the skin , size of pores , skin elasticity , tone , and reduction in pigmented lesions and mottled hyperpigmentation .
RESULTS	A statistically significant difference was found in the improvement of group A ( Wilcoxon test < 0.01 ) .
RESULTS	Using minimal amounts of this drug , the side effects were practically negligible .
CONCLUSIONS	Utilizing various procedures with oral isotretinoin allowed us to improve the effects of cutaneous aging .
CONCLUSIONS	Our results using isotretinoin in these cases have been satisfactory .
CONCLUSIONS	We believe that this is one of the first reports of the use of oral isotretinoin in intrinsic and photoaged skin .

###20607434
BACKGROUND	U.S. Hispanic women suffer a disproportionate burden of cervical cancer , with incidence and mortality rates almost twice that of whites .
BACKGROUND	Community health workers , or promotoras , are considered a potential strategy for eliminating such racial and ethnic health disparities .
BACKGROUND	The current study is a randomized trial of a promotora-led educational intervention focused on cervical cancer in a local Hispanic community .
METHODS	Four promotoras led a series of two workshops with community members covering content related to cervical cancer .
METHODS	Sociodemographic characteristics , cervical cancer risk , previous screening history , cervical cancer knowledge , and self-efficacy were measured by a pre-intervention questionnaire .
METHODS	The post-intervention questionnaire measured the following outcomes : cervical cancer knowledge ( on a 0-6 scale ) , self-efficacy ( on a 0-5 scale ) , and receipt of Pap smear screening during the previous 6 months ( dichotomous ) .
METHODS	Univariate analyses were performed using chi square , t-test , and the Mann-Whitney test .
METHODS	Multivariate logistic regression was used to model the association between explanatory variables and receipt of Pap smear screening .
RESULTS	There were no statistically significant differences between the two experimental groups at baseline .
RESULTS	Follow-up data revealed significant improvements in all outcome measures : Pap smear screening ( 65 % vs. 36 % , p-value 0.02 ) , cervical cancer knowledge ( 5.4 vs. 3.5 , p-value < 0.001 ) , and self-efficacy ( 4.7 vs. 4.0 , p-value 0.002 ) .
RESULTS	In multivariate analysis , cervical cancer knowledge ( OR 1.68 , 95 % CI 1.10-2 .81 ) and intervention group assignment ( OR 6.74 , 95 % CI 1.77-25 .66 ) were associated with receiving a Pap smear during the follow-up period .
CONCLUSIONS	Our randomized trial of a promotora-led educational intervention demonstrated improved Pap screening rates , in addition to increased knowledge about cervical cancer and self-efficacy .
CONCLUSIONS	The observed association between cervical cancer knowledge and Pap smear receipt underscores the importance of educating vulnerable populations about the diseases that disproportionately affect them .
CONCLUSIONS	Future research should evaluate such programs on a larger scale , and identify novel targets for intervention .

###7795774
OBJECTIVE	To determine whether an over-the-counter shampoo containing 1 % selenium sulfide would have sporicidal activity equal to that of a 2.5 % selenium sulfide prescription lotion in the adjunctive treatment of tinea capitis infection .
METHODS	Prospective randomized nonblinded clinical trial .
METHODS	Outpatient clinics and emergency department of a children 's hospital .
METHODS	Fifty-four patients between the ages of 1 and 15 years with culture-proved tinea capitis infection caused by Trichophyton tonsurans enrolled during a 14-month period .
METHODS	Patients were randomized to receive 2.5 % selenium sulfide lotion , 1 % selenium sulfide shampoo , or a bland , nonmedicated shampoo with which they were instructed to shampoo twice weekly .
METHODS	All received 15 mg/kg per day of griseofulvin .
METHODS	Dermatophyte cultures of the affected area of each patient 's scalp were obtained on enrollment and every 2 weeks until a negative culture was obtained from a previously infected area .
RESULTS	Survival data analysis demonstrated that both the 2.5 % selenium sulfide and 1 % selenium sulfide preparations were superior to the nonmedicated control shampoo in terms of the time required to eliminate shedding of viable spores .
RESULTS	When compared with each other , there was no difference between the 2.5 % selenium sulfide and 1 % selenium sulfide preparations in time required to produce a negative culture .
CONCLUSIONS	Commercially available 1 % selenium sulfide shampoo is an equally effective yet less expensive alternative sporicidal therapy in the adjunctive treatment of tinea capitis infection .

###23985436
OBJECTIVE	To compare the efficacy of a new dentifrice containing 1.5 % arginine , an insoluble calcium compound , and 1450 ppm fluoride to a matched , positive control dentifrice containing 1450 ppm fluoride in arresting and reversing early coronal caries lesions in children using Quantitative Light-induced Fluorescence ( QLF ) .
METHODS	331 children from Chiang Mai , Thailand , aged 7-14 years , with one or more visible early enamel caries lesions on the upper anterior teeth , completed the study .
METHODS	The new dentifrice contained 1.5 % arginine , an insoluble calcium compound , and 1450 ppm fluoride , as sodium monofluorophosphate ; the matched positive control contained 1450 ppm fluoride only .
METHODS	Subjects brushed twice daily at home and additionally once on school days under teacher 's supervision .
METHODS	Digital images of the upper six anterior teeth were captured at the baseline , 3 - and 6-month examinations using a custom apparatus for reproducible acquisition of Quantitative Light-induced Fluorescence data .
RESULTS	At the 3-month examination , the Q ( representing lesion volume ) for the test group decreased from a mean of 28.62 at baseline to 20.53 mm ( 2 ) % and for the positive control group to 23.38 mm ( 2 ) % .
RESULTS	The difference between groups was not statistically significant ( p = 0.055 ) .
RESULTS	At the 6-month examination , the Q decreased for the test group to 15.85 mm ( 2 ) % and for the positive control group to 20.35 mm ( 2 ) % .
RESULTS	The difference between groups was statistically significant ( p < 0.001 ) .
CONCLUSIONS	A new dentifrice containing 1.5 % arginine , an insoluble calcium compound , and 1450 ppm fluoride , as sodium monofluorophosphate , provided statistically significant superior efficacy in arresting and reversing active coronal caries lesions in children than brushing with a matched positive control dentifrice containing fluoride alone .

###18498919
OBJECTIVE	This study was conducted to determine the effects of carvedilol adjunct to standard treatment on left ventricular function ( LVF ) , estimated as ejection fraction ( EF ) and fractional shortening ( FS ) on echocardiography , in children with idiopathic dilated cardiomyopathy ( DCM ) .
OBJECTIVE	A secondary end point was to characterize the antioxidant potential of carvedilol .
METHODS	Hospitalized children aged < or = 16 years with clinically stable DCM and advanced congestive heart failure ( HF ) with modified New York Heart Association Classification for Children ( NYHAC ) functional classes II to IV and EF < 40 % were enrolled in this prospective , 12-month , 2-center , open-label study .
METHODS	Oral carvedilol was added to a standard regimen of an angiotensin-converting enzyme inhibitor , a diuretic , and digoxin in a dose-escalation design .
METHODS	Systolic and diastolic blood pressure ( BP ) , heart rate ( HR ) , and modified NYHAC were assessed before ( baseline ) and at 1 , 3 , 6 , and 12 months of adjunct carvedilol treatment .
METHODS	EF and FS were analyzed before and at 6 and 12 months of carvedilol treatment .
METHODS	At each study visit , tolerability was assessed in terms of adverse events ( AEs ) , treatment emergent signs and symptoms , physical examination including vital sign measurement ( BP , HR , and body temperature ) , and laboratory analysis .
METHODS	Antioxidative enzyme activity was evaluated by measuring erythrocyte copper/zinc superoxide dismutase ( SOD ) , catalase ( CAT ) , glutathione peroxidase ( GSH-Px ) , and glutathione reductase ( GR ) activity at baseline and 1 , 3 , 6 , and 12 months of adjunct carvedilol treatment .
METHODS	For assessment of antioxidative enzyme activity , a control group comprised 29 age-matched healthy children .
RESULTS	Twenty-one children ( 12 boys , 9 girls ; age range , 7 months to 16 years ; 100 % white ) completed the study .
RESULTS	Four patients discontinued carvedilol at the beginning of the study due to severe arrhythmia which required amiodarone therapy ( 2 patients ) , bradycardia and hypotension ( 1 ) , and bronchospasm ( 1 ) .
RESULTS	Carvedilol ( 0.4 mg/kg/d in children < or = 62.5 kg or 25 mg/d in children > 62.5 kg ) was associated with significant decreases from baseline in systolic BP ( 130 [ 4 ] vs 123 [ 3 ] mm Hg ; P < 0.05 ) , diastolic BP ( 85 [ 4 ] vs 77 [ 4 ] mm Hg ; P < 0.05 ) , and HR ( 81 [ 4 ] vs 65 [ 4 ] bpm ; P < 0.001 ) after the first month of addition to standard therapy .
RESULTS	At 6 months , there were significant improvements from baseline in EF ( 37.2 % [ 2.4 % ] vs 50.2 % [ 2.3 % ] ; P < 0.001 ) and FS ( 18.37 % [ 2.00 % ] vs 23.58 % [ 0.90 % ] ; P < 0.001 ) .
RESULTS	Modified NYHAC class was significantly improved in 80 % of children ( 2.9 vs 2.3 ; P < 0.001 ) at 12 months .
RESULTS	The highest dose of carvedilol ( 0.8 mg/kg/d in children < or = 62.5 kg or 50 mg/d in children > 62.5 kg ) was well tolerated in all 21 children .
RESULTS	No serious AEs that necessitated study drug discontinuation ( tiredness , headache , vomiting ) were observed .
RESULTS	At baseline , mean ( SE ) erythrocyte SOD activity ( 2781 [ 116 ] vs 2406 [ 102 ] U/g Hb ; P < 0.05 ) and GR activity ( 5.3 [ 0.3 ] vs 3.0 [ 0.2 ] micromol nicotinamide adenine dinucleotide phosphate [ NADPH ] / min/g Hb ; P < 0.001 ) were significantly higher in children with DCM who received standard therapy compared with healthy controls.CAT activity ( 12.7 [ 0.9 ] vs 18.5 [ 1.0 ] U/g Hb ; P < 0.001 ) was significantly lower , while GSH-Px was unchanged .
RESULTS	At 6 and 12 months of therapy , carvedilol plus standard treatment was associated with significant decreases from baseline in SOD ( 2516 [ 126 ] and 2550 [ 118 ] , respectively , vs 2781 [ 116 ] U/g Hb ; both , P < 0.001 ) and GR ( 4.7 [ 0.3 ] and 4.1 [ 0.2 ] , respectively , vs 5.3 [ 0.2 ] micromol NADPH/min/g Hb ; P < 0.05 and P < 0.001 ) and increased CAT ( 16.9 [ 1.0 ] and 16.4 [ 0.7 ] , respectively , vs 12.7 [ 0.9 ] U/g Hb ; both , P < 0.001 ) .
CONCLUSIONS	These pediatric patients with DCM treated for 12 months with carvedilol ( up to 0.8 mg/kg/d in children < or = 62.5 kg or 50 mg/d in children > 62.5 kg ) were found to have significant improvements in LVF and symptoms of HF .
CONCLUSIONS	Twelve months of carvedilol therapy was associated with antioxidant enzyme activities near those observed in healthy children .

###24111982
OBJECTIVE	The purpose of this study was to investigate associations between body weight and illness characteristics , including weight gain and therapeutic efficacy , in adolescents with schizophrenia .
METHODS	Adolescents ages 13-17 years ( n = 107 ) with American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed .
METHODS	( DSM-IV ) schizophrenia enrolled in a 6 week , double-blind , placebo-controlled trial comparing olanzapine and placebo .
METHODS	Therapeutic response was assessed by the Brief Psychiatric Rating Scale for Children ( BPRS-C ) .
METHODS	Secondary outcomes included the Clinical Global Impressions-Severity ( CGI-S ) scale and Positive and Negative Syndrome Scale ( PANSS ) .
METHODS	Obesity was defined as sex - / age-adjusted body mass index ( BMI ) 95th percentile .
METHODS	Linear regression was used to analyze the relationship between weight gain and psychiatric symptom improvement ; logistic regression was conducted to identify predictors of baseline obesity .
RESULTS	Weight gain was significantly correlated with greater BPRS-C reduction among olanzapine-treated subjects ( r = -0.31 , p < 0.01 ) , whereas a trend was observed among placebo-treated subjects ( r = -0.31 , p = 0.08 ) .
RESULTS	However , this relationship became nonsignificant when analyses were controlled for duration of olanzapine treatment ( p = 0.12 ) , and a treatment by weight gain interaction did not emerge in a repeated-measures mixed model analysis that included time in the study ( t = 1.27 , p = 0.21 ) .
RESULTS	Additionally , weight gain 7 % was not significantly associated with response or remission .
RESULTS	Among 17 adolescents ( 16 % ) with obesity at study entry , obesity was not significantly associated with endpoint BPRS-C illness severity .
RESULTS	However , girls ( p = 0.03 ) , individuals hospitalized within the past year ( p = 0.02 ) , and those with less severe overall ( p = 0.03 ) and negative symptoms ( p = 0.003 ) according to the CGI-S and PANSS negative subscale , respectively , were more likely to be obese at baseline .
CONCLUSIONS	Baseline obesity was associated with lower illness severity , which could be mediated by greater treatment adherence , leading to more weight gain .
CONCLUSIONS	Olanzapine-related weight gain was not independently associated with symptomatic outcome when controlling for treatment duration .
CONCLUSIONS	Additional studies are needed to extend these findings to other disorders and medications .

###25522560
OBJECTIVE	Invastigation of macrolides in the treatment of drug effects in chronic rhinosinusit .
METHODS	The 165 patients with chronic rhinosinusit were randomly divided into 80 cases of macrolides drug group and 85 cases of cephalosporins group , and therapeutic effect was observed .
METHODS	The therapeutic effect of macrolides was also observed in refractory chronic rhinosinusit .
RESULTS	Comparing macrolides group and cephalosporins group , there is not statistically significant ( P > 0.05 ) .
RESULTS	Treatment with macrolides cefixime tablet ineffective treatment of patients for 3 months , compared before and after treatment was statistically significant ( P < 0.01 ) .
RESULTS	Treatment with cefixime tablet macrolides ineffective treatment of patients for 3 months , compared before and after treatment was not statistically significant ( P > 0.05 ) .
CONCLUSIONS	Long-term low-dose applications of macrolides have a good effect in patients with chronic rhinosinusit , particularly for refractory chronic rhinosinusit have a significant effect .

###22447415
OBJECTIVE	The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia .
OBJECTIVE	Pharmacodynamics , safety and patient-reported quality of life ( QoL ) outcomes were also evaluated .
OBJECTIVE	One of several benefits of the new formulation is increased bioavailability .
OBJECTIVE	Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability .
METHODS	This was a 4-week , randomized , double-blind study comparing 10 , 25 , 50 , or 100g desmopressin versus placebo in adults with defined nocturia .
RESULTS	The intent to treat population comprised 757 patients experiencing 3 voids/night and a high prevalence of nocturnal polyuria ( 90 % ) .
RESULTS	Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume , greater proportions of subjects with > 33 % reduction in nocturnal voids , and increased duration of first sleep period .
RESULTS	The lowest dose reaching statistical significance ( P < 0.05 vs. placebo ) varied by endpoint .
RESULTS	Improvements were clinically meaningful , meaning that patients actually had fewer nightly voids .
RESULTS	Post hoc analyses by gender suggested a lower minimum effective dose for women .
RESULTS	Desmopressin was generally well tolerated .
RESULTS	Reductions in serum sodium to < 125mmol/L in six women ( taking > 25g desmopressin ) and two men ( aged 67 and 82 ) taking 100g , support lower and gender-specific dosing to reduce the small but clinically significant risk of hyponatraemia .
RESULTS	Each void reduced/hour of sleep gained was associated with significant improvements in QoL .
CONCLUSIONS	Desmopressin orally disintegrating tablet is an effective and well-tolerated treatment for patients with nocturia .
CONCLUSIONS	Further exploration of the lower dose range is warranted .

###18201212
OBJECTIVE	To assess the effect of liraglutide , a once-daily human glucagon-like peptide-1 analogue on pancreatic B-cell function .
OBJECTIVE	methods : Patients with Type 2 diabetes ( n = 39 ) were randomized to treatment with 0.65 , 1.25 or 1.9 mg/day liraglutide or placebo for 14 weeks .
OBJECTIVE	First - and second-phase insulin release were measured by means of the insulin-modified frequently sampled intravenous glucose tolerance test .
OBJECTIVE	Arginine-stimulated insulin secretion was measured during a hyperglycaemic clamp ( 20 mmol/l ) .
OBJECTIVE	Glucose effectiveness and insulin sensitivity were estimated by means of the insulin-modified frequently sampled intravenous glucose tolerance test .
RESULTS	The two highest doses of liraglutide ( 1.25 and 1.9 mg/day ) significantly increased first-phase insulin secretion by 118 and 103 % , respectively ( P < 0.05 ) .
RESULTS	Second-phase insulin secretion was significantly increased only in the 1.25 mg/day group vs. placebo .
RESULTS	Arginine-stimulated insulin secretion increased significantly at the two highest dose levels vs. placebo by 114 and 94 % , respectively ( P < 0.05 ) .
RESULTS	There was no significant treatment effect on glucose effectiveness or insulin sensitivity .
CONCLUSIONS	Fourteen weeks of treatment with liraglutide showed improvements in first - and second-phase insulin secretion , together with improvements in arginine-stimulated insulin secretion during hyperglycaemia .

###24999282
OBJECTIVE	Latrodectism is the most important spider envenomation syndrome worldwide .
OBJECTIVE	There remains considerable controversy over antivenom treatment .
OBJECTIVE	We aimed to investigate whether antivenom resulted in resolution of pain and systemic effects in patients with latrodectism who received standardized analgesia .
METHODS	In a multicenter randomized placebo-controlled trial of redback spider antivenom for latrodectism , 224 patients ( > 7 years ) with a redback spider bite and severe pain , with or without systemic effects , were randomized to receive normal saline solution ( placebo ) or antivenom after receiving standardized analgesia .
METHODS	The primary outcome was a clinically significant reduction in pain 2 hours after trial medication compared with baseline .
METHODS	A second primary outcome for the subgroup with systemic features of envenomation was resolution of systemic features at 2 hours .
METHODS	Secondary outcomes were improved pain at 4 and 24 hours , resolution of systemic features at 4 hours , administration of opioid analgesics or unblinded antivenom after 2 hours , and adverse reactions .
RESULTS	Two hours after treatment , 26 of 112 patients ( 23 % ) from the placebo arm had a clinically significant improvement in pain versus 38 of 112 ( 34 % ) from the antivenom arm ( difference in favor of antivenom 10.7 % ; 95 % confidence interval -1.1 % to 22.6 % ; P = .10 ) .
RESULTS	Systemic effects resolved after 2 hours in 9 of 41 patients ( 22 % ) in the placebo arm and 9 of 35 ( 26 % ) in the antivenom arm ( difference 3.8 % ; 95 % confidence interval -15 % to 23 % ; P = .79 ) .
RESULTS	There was no significant difference in any secondary outcome between antivenom and placebo .
RESULTS	Acute systemic hypersensitivity reactions occurred in 4 of 112 patients ( 3.6 % ) receiving antivenom .
CONCLUSIONS	The addition of antivenom to standardized analgesia in patients with latrodectism did not significantly improve pain or systemic effects .

###20979935
OBJECTIVE	Controlled-release levodopa/carbidopa ( CR-LC ) is often used to provide prolonged control of night-time motor symptoms in patients with Parkinson 's disease ( PD ) .
OBJECTIVE	Levodopa/carbidopa/entacapone ( LCE ) provides higher bioavailability of levodopa compared with levodopa/carbidopa formulations and has been shown to be effective in PD patients with wearing-off symptoms .
OBJECTIVE	The aim of this study was to compare the bioavailability of levodopa after a single evening dose ( administered at 10 p.m. ) of LCE 200 or CR-LC 200 .
METHODS	This was an open-label , randomized , crossover study in healthy subjects .
METHODS	The main pharmacokinetic ( PK ) parameters were AUC , Cmax , C6h and t1/2 of levodopa .
RESULTS	A single evening dose of LCE 200 was associated with significantly better bioavailability compared with CR-LC 200 .
RESULTS	In line with increased bioavailability of levodopa , LCE 200 induced more nausea .
CONCLUSIONS	The results of this study demonstrate that a single bedtime dose of LCE 200 provides higher bioavailability of levodopa compared to CR-LC 200 .

###20588105
OBJECTIVE	Protease inhibitor therapy is associated with an increased risk of myocardial infarction .
OBJECTIVE	Half this risk appears attributable to fasting dyslipidemia , but half remains unexplained .
OBJECTIVE	We compared the fasting and postprandial effects of low-dose ritonavir and raltegravir on cardiovascular and metabolic risk factors .
METHODS	Randomized ( 1 : 1 ) , open-label study .
METHODS	Twenty HIV-uninfected volunteers ( 14 women , mean age 32 years ) received low-dose ritonavir ( 100 mg daily ) or raltegravir ( 400 mg twice daily ) for 4 weeks .
METHODS	We administered a standardized meal ( 3.6 MJ , 76 % fat , 10 % carbohydrates ) at baseline and at week 4 , with hourly assessments for 6 h after each meal .
METHODS	The primary outcome measure was incremental area under the curve ( iAUC ) change in postprandial lipids .
RESULTS	Ritonavir induced significantly higher postprandial iAUC excursions in low-density lipoprotein ( LDL ) cholesterol than raltegravir , mostly in the first 3 h after food ( P < 0.05 ) .
RESULTS	The ritonavir-related postprandial increases in LDL cholesterol at 1 , 2 , and 3 h were 30-65 % greater than the ritonavir-related increase in fasting LDL cholesterol ( 0.34-0 .43 vs. 0.26 mmol/l , P < 0.05 for each comparison ) .
RESULTS	The postprandial iAUC and fasting LDL cholesterol changes at week 4 were significantly correlated ( r = 0.64 ; P = 0.003 ) .
RESULTS	There was no between-group difference for other postprandial parameters .
CONCLUSIONS	In HIV-uninfected adults , postprandial LDL cholesterol excursions with low-dose ritonavir were significantly greater than those with raltegravir .
CONCLUSIONS	This postprandial effect of ritonavir increased by about 50 % the previously observed adverse effect of ritonavir on fasting LDL cholesterol , and so may explain some of the hitherto unexplained association of protease inhibitor-based therapy with cardiovascular disease .

###18768436
OBJECTIVE	Patients with early breast cancer who receive anthracycline-containing chemotherapy experience improved relapse-free ( RFS ) and overall survival ( OS ) compared with those who receive non-anthracycline-containing chemotherapy .
OBJECTIVE	Such benefit , however , may be restricted to women whose tumors have specific molecular characteristics .
OBJECTIVE	We tested the hypothesis that HER2 , epidermal growth factor receptor ( EGFr ) / HER1 , HER3 , Ki67 , and topoisomerase IIalpha expression are predictive of outcome after anthracycline-based chemotherapy .
METHODS	Tissue microarrays from 322 of 374 women in the BR9601 trial , which compared cyclophosphamide , methotrexate , and fluorouracil ( CMF ) with epirubicin followed by CMF ( epi-CMF ) , were analyzed for HER1 , 2 , 3 , 4 ; Ki67 ; and topoisomerase IIalpha protein expression and for HER2/topoisomerase IIalpha gene amplification .
METHODS	Their relationships to RFS and OS were investigated , and multiple regression analysis was used to identify interactions .
RESULTS	A significant interaction was seen between tumors with normal HER1 , HER2 fluorescent in situ hybridization ( FISH ) , or HER3 levels and the enhanced benefit from epi-CMF versus CMF for RFS ( hazard ratio [ HR ] , 0.36 ; HR for overexpressed HER1 or HER2 FISH or HER3 , 0.92 ; P = .035 ) and for OS ( HR , 0.30 ; HR for overexpressed HER1 or HER2 FISH or HER3 ) , 0.98 ; P = .023 ) .
RESULTS	Neither Ki67 nor TIIalpha expressions or gene alterations showed clear predictive value for benefit from the addition of the anthracycline .
CONCLUSIONS	Patients with HER2 amplified and those with HER1 , HER2 FISH , or HER3-positive tumors did not benefit from the addition of epirubicin to CMF .
CONCLUSIONS	Conversely , patients with HER2 nonamplified and HER1 through HER3-negative tumors showed significantly increased RFS and OS rates when treated with epi-CMF compared with CMF .

###15024533
OBJECTIVE	To analyse whether the use of different groups of psychotropic medicines among educational groups in a general population was congruent with the occurrence of related diseases .
METHODS	Data from The Danish Health and Morbidity Survey 2000 were analysed .
METHODS	The survey was conducted by face-to-face interviews with a representative sample of the Danish population aged 16 years and above ( n = 16,690 ) .
METHODS	The prevalence of four different types of psychotropic medicine use and related diseases in educational groups was analysed by indirect standardisation .
METHODS	Age and gender standardised prevalence ratios ( SPRs ) and 95 % confidence intervals were calculated based on the total study population .
RESULTS	In general , respondents in the two least-educated groups used psychotropic medicines more often and had a higher proportion reporting the related disease than could be expected according to indirect standardisation .
RESULTS	The opposite picture appeared for respondents in the two highest educated groups ( SPR < 100 ) .
RESULTS	The overall patterns were similar for all four groups of psychotropic medicine users , although some of the SPRs were not significant .
CONCLUSIONS	The results documented an uneven distribution of health problems in the general population .
CONCLUSIONS	Psychotropic medicine use was congruent with the distribution of related health problems , which means that the least-educated groups in most need of treatment also had the most-frequent medicine use .
CONCLUSIONS	Expenses incurred by the individual user did not seem to be a barrier to access to medicines , not even for specific groups of medicine ineligible for reimbursement in Denmark .

###9196141
OBJECTIVE	To determine the appropriate irradiation dose after four cycles of modern combination chemotherapy in nonbulky involved field ( IF/BF ) and noninvolved extended-field ( EF/IF ) sites in patients with intermediate-stage Hodgkin 's disease ( HD ) .
METHODS	HD patients in stage I to IIIA with a large mediastinal mass , E stage , or massive spleen involvement were treated with two double cycles of alternating cyclophosphamide , vincristine , procarbazine , and prednisone ( COPP ) plus doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) followed by EF irradiation in two successive trials ( HD1 and HD5 ) .
METHODS	In the HD1 trial ( 1983 to 1988 ) , 146 patients who responded to chemotherapy were randomized to receive 20 Gy ( 70 patients ) or 40 Gy ( 76 patients ) of EF irradiation in all fields outside bulky disease sites .
METHODS	A cohort of 111 patients who fulfilled the same inclusion criteria in the subsequent trial HD5 ( 1988 to 1993 ) were treated with 30 Gy .
METHODS	Bulky disease always received 40 Gy .
RESULTS	Freedom-from-treatment-failure ( FFTF ) and survival ( SV ) curves showed no differences between the 20 - , 30 - , and 40-Gy groups .
RESULTS	However , acute toxicities were more frequent in the 40-Gy arm .
RESULTS	Analysis of relapse patterns showed that 18 of 26 relapsing patients either failed to respond in initial bulky sites ( n = 5 ) or had an extranodal relapse ( n = 9 ) or both ( n = 4 ) .
RESULTS	After 5 years , the cumulative risk for relapse in bulky sites is 10 % , despite 40 Gy of radiation .
CONCLUSIONS	Our results strongly suggest that there is no relevant radiotherapy dose effect in the range between 20 Gy and 40 Gy in IF/BF and EF/IF after 4 months of modern polychemotherapy in patients with intermediate-stage HD .
CONCLUSIONS	Relapse patterns indicate that patients destined to relapse need more systemic , rather than local , treatment .
CONCLUSIONS	Based on our data , we conclude that 20 Gy is sufficient in EF/IF of intermediate-stage HD following four cycles of modern polychemotherapy .

###24940305
BACKGROUND	Recently some plasma biomarkers of inflammation have been recognized as important cardiovascular risk factors .
BACKGROUND	There is little information about the effects of aerobic exercise training on these biomarkers and the risk of metabolic complications in obese type 2 diabetes patients .
OBJECTIVE	To compare the impact of moderate versus mild aerobic exercise training on the inflammatory cytokines in obese type 2 diabetic patients .
METHODS	Fifty obese type 2 diabetic patients of both sexes with body mass index ( BMI ) varying from 31 to 36 kg/m ( 2 ) , non smokers , free from respiratory , kidney , liver , metabolic and neurological disorders , participated in this study .
METHODS	Their age ranged from 40 to 55 years .
METHODS	The subjects were included into two equal groups ; the first group ( A ) received moderate aerobic exercise training .
METHODS	The second group ( B ) received mild aerobic exercise training , three times / week for 3 months .
RESULTS	The mean values of leptin , TNF - alpha , IL2 , IL4 , IL6 , HOMA-IR and HBA1c were significantly decreased in group ( A ) and group ( B ) .
RESULTS	Also , there were significant differences between both groups after treatment .
CONCLUSIONS	Moderate aerobic exercise training modulates inflammatory cytokines more than mild aerobic exercise training in obese type 2 diabetic patients .

###10392982
BACKGROUND	Case management has increasingly been the recommended approach to care for severely mentally ill patients since the number of psychiatric beds has decreased .
BACKGROUND	Despite equivocal results , in the UK and Europe , this approach is becoming accepted policy .
BACKGROUND	We assessed the effect of smaller case loads .
METHODS	We randomly assigned 708 psychotic patients in four centres standard case management ( 355 patients , case load 30-35 per case manager ) or intensive case management ( 353 patients , case load 10-15 per case manager ) .
METHODS	We measured clinical symptoms and social functioning at baseline , 1 year , and 2 years .
METHODS	The impact of treatment on hospital use was assessed at 2 years by subgroup analyses for Afro-Caribbean and for severely socially disabled patients .
METHODS	Analysis was by intention to treat .
RESULTS	There was no significant decline in overall hospital use among intensive-case-management patients ( mean 73.5 vs 73.1 days in those who received standard care [ SD 0.4 , 95 % CI -17.4 to 18.1 ] ) , nor were there any significant gains in clinical or social functioning .
RESULTS	There was no evidence of differential effect in Afro-Caribbean patients or the most socially disabled patients .
CONCLUSIONS	In well-coordinated mental-health services , a decline in case load alone does not improve outcome for these patients .
CONCLUSIONS	Mental-health planners may need to pay more attention to the content of treatment rather than changes in service organisation .

###8728305
OBJECTIVE	To investigate whether the M235T polymorphism of the angiotensinogen ( AGT ) gene and the insertion/deletion ( I/D ) polymorphism of the angiotensin-1 converting enzyme ( ACE ) gene predict blood pressure response to different antihypertensive agents .
METHODS	Sixty-three patients with untreated essential hypertension were randomly assigned in a placebo-controlled crossover comparison to atenolol 50 mg once daily , lisinopril 10 mg once daily and nifedipine SR 20 mg twice daily , and the effect on blood pressure was assessed by ambulatory blood pressure monitoring ( ABPM ) .
METHODS	In a further 44 patients , placebo-controlled ABPM data were available after treatment with a single agent ( atenolol 50 mg once daily in 16 cases and lisinopril 10mg once daily in 28 cases ) .
METHODS	The change in systolic and diastolic blood pressure achieved by each agent was analysed for association with genotypes at the AGT and ACE gene loci .
METHODS	Polymerase chain reaction ( PCR ) amplification of genomic DNA from each individual was used to identify the I/D polymorphism of the ACE gene .
METHODS	The M235T polymorphism of the AGT gene was detected by Tth111I digestion of PCR product .
RESULTS	There was no significant association between response to any drug and either the AGT M235T or ACE I/D polymorphisms .
CONCLUSIONS	The large variability between individuals in the observed blood pressure response to these agents can not be attributed to the polymorphisms analysed at the ACE and AGT loci .

###23071195
OBJECTIVE	To assess the feasibility and effectiveness of a newly developed assistive technology system , Lee Silverman Voice Treatment Companion ( LSVT ( ) Companion , hereafter referred to as `` Companion '' ) , to support the delivery of LSVT ( ) LOUD , an efficacious speech intervention for individuals with Parkinson disease ( PD ) .
METHODS	Sixteen individuals with PD were randomized to an immediate ( n = 8 ) or a delayed ( n = 8 ) treatment group .
METHODS	They participated in 9 LSVT LOUD sessions and 7 Companion sessions , independently administered at home .
METHODS	Acoustic , listener perception , and voice and speech rating data were obtained immediately before ( pre ) , immediately after ( post ) , and at 6 months post treatment ( follow-up ) .
METHODS	System usability ratings were collected immediately post treatment .
METHODS	Changes in vocal sound pressure level were compared to data from a historical treatment group of individuals with PD treated with standard , in-person LSVT LOUD .
RESULTS	All 16 participants were able to independently use the Companion .
RESULTS	These individuals had therapeutic gains in sound pressure level , pre to post and pre to follow-up , similar to those of the historical treatment group .
CONCLUSIONS	This study supports the use of the Companion as an aid in treatment of hypokinetic dysarthria in individuals with PD .
CONCLUSIONS	Advantages and disadvantages of the Companion , as well as limitations of the present study and directions for future studies , are discussed .

###12753445
BACKGROUND	This study was conducted to evaluate analgesia and side-effects of caudal neostigmine coadministered with bupivacaine in paediatric surgery .
METHODS	We studied children , aged 1-5 years , undergoing elective surgery ( inguinal hernia and hypospadias ) .
METHODS	After standard induction of anaesthesia , caudal anaesthesia was performed .
METHODS	Group 1 received 0.25 % bupivacaine 0.5 ml.kg-1 and Group 2 received 0.25 % bupivacaine 0.5 ml x kg-1 with 1 microg x kg-1 neostigmine via the caudal route .
METHODS	Heart rate , mean arterial pressure , peripheral oxygen saturation were recorded before induction , after induction but before caudal anaesthesia , and then every 5 min after caudal anaesthesia .
METHODS	Haemodynamic , Toddler , Preschooler , Postoperative Pain Scale ( TPPPS ) pain score and sedation score values were recorded 30 min after extubation and at hours 2 , 4 , 6 , 12 and 24 .
METHODS	A pain score > 3/10 resulted in administration of rectal paracetamol .
METHODS	The duration of postoperative analgesia was defined as the time between caudal drug injection and the first rectal paracetamol administration .
RESULTS	There were no differences between the groups in demographic and haemodynamic date , duration of surgery and anaesthesia , time to extubation or sedation scores .
RESULTS	The duration of postoperative pain relief did not differ between the two groups ; 15.40 + / - 10.97 h for group 1 vs. 15.45 + / - 10.99 h for group 2 ( P > 0.05 ) .
RESULTS	The incidence of nausea ( three patients in group 2 and one patient in group 1 ) was not statistically significant .
RESULTS	No other side-effects were seen .
CONCLUSIONS	We found that a single caudal injection of 1 microg x kg-1 neostigmine mixed with bupivacaine offers no significant advantage over bupivacaine alone for postoperative pain relief in children undergoing genitourinary surgery .

###24755130
OBJECTIVE	Acute pain can lead to immune dysfunction , which can be partly ameliorated by successful pain management .
OBJECTIVE	Opioids , which are widely used for analgesia , can result in the deterioration of immune function .
OBJECTIVE	This study aimed to investigate the influence of morphine with or without flurbiprofen as post-operative analgesics on the immune systems of patients undergoing gastric cancer surgery .
METHODS	60 patients undergoing gastric cancer surgery were equally randomized into two groups .
METHODS	They received post-operative patient-controlled intravenous ( IV ) analgesia using morphine either with or without flurbiprofen .
METHODS	Visual analogue scale ( VAS ) scores , Bruggemann comfort scale ( BCS ) scores , morphine consumption , time of first flatus , incidence of nausea/vomiting , and T-lymphocyte subsets ( CD3 , CD4 , and CD8 ) and natural killer cells ( CD3CD16CD56 ) were evaluated .
RESULTS	No significant difference was observed in the VAS scores , BCS scores , and nausea/vomiting incidence between groups .
RESULTS	Less morphine was consumed and the time of first flatus was earlier in patients receiving morphine with flurbiprofen than morphine alone .
RESULTS	The expression of CD3 , CD4 , CD4/CD8 , and CD3CD16CD56 decreased at 2 hours after incision and , except for CD3CD16CD56 , returned to baseline at 120 hours after surgery .
RESULTS	Moreover , the expression of CD3CD16CD56 at 2 hours after incision and the expression of CD3 , CD4 , CD4/CD8 , and CD3CD16CD56 at 24 hours after surgery were higher in patients receiving morphine with flurbiprofen than morphine alone .
CONCLUSIONS	The combination of morphine and flurbiprofen ameliorates the immune depression in Tlymphocyte subsets and natural killer cells and provides a similar analgesic efficacy to morphine alone in patients undergoing gastric cancer surgery .

###15598773
OBJECTIVE	The objective of this study was to determine an effective dose for all-trans retinoic acid ( atRA ) delivered with a cervical cap and sponge for 4 days to women with cervical intraepithelial neoplasia ( CIN ) II/III .
METHODS	Study participants made up of 175 women with biopsy-proven CIN II/III were randomized to four consecutive days of atRA at one of three doses ( 0.16 % , 0.28 % , and 0.36 % ) or placebo .
METHODS	All subjects underwent a repeat colposcopy evaluation and biopsy of the cervix at 12 weeks .
RESULTS	The study participants mean ages were 27.6 years .
RESULTS	The racial distribution was 63 % Caucasian , 27 % African American , and 8 % other .
RESULTS	Among participants , 93 % were human papillomavirus-positive at baseline with 68 % positive for high-risk types .
RESULTS	The disease response at 12 weeks to atRA or placebo was not significantly different ( P = 0.49 ) among the four dose groups .
RESULTS	Participants with CIN II at baseline were more likely to be free of disease at 12 weeks than participants with CIN III at baseline ( P = 0.003 ) .
RESULTS	There were no reported systemic adverse events related to drug or placebo exposure and only mild local self-reported and clinician-detected toxicities .
CONCLUSIONS	Lower concentrations of atRA applied with a cervical cap for 4 days were no more effective than placebo .
CONCLUSIONS	However , the rate of histologic regression in biopsied CIN II/III patients was high even over a short time interval , and emphasizes the importance of having a placebo arm and an adequate sample size .

###9462572
OBJECTIVE	The goal of this study was to compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries .
BACKGROUND	Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters > or = 3.0 mm .
BACKGROUND	The efficacy of elective stent placement in smaller vessels has not been determined .
METHODS	By quantitative coronary angiography , 331 patients in the Stent Restenosis Study ( STRESS ) I-II were determined to have a reference vessel < 3.0 mm in diameter .
METHODS	Of these , 163 patients were randomly assigned to stenting ( mean diameter 2.69 + / - 0.21 mm ) , and 168 patients were assigned to angioplasty ( mean diameter 2.64 + / - 0.24 mm ) .
METHODS	The primary end point was restenosis , defined as > or = 50 % diameter stenosis at 6-month follow-up angiography .
METHODS	Clinical event rates at 1 year were assessed .
RESULTS	Baseline clinical and angiographic characteristics were similar in the two groups .
RESULTS	Procedural success was achieved in 100 % of patients assigned to stenting and in 92 % of patients assigned to angioplasty ( p < 0.001 ) .
RESULTS	Abrupt closure within 30 days occurred in 3.6 % of patients in both groups .
RESULTS	Compared with angioplasty , stenting conferred a significantly larger postprocedural lumen diameter ( 2.26 vs. 1.80 mm , p < 0.001 ) and a larger lumen at 6 months ( 1.54 vs. 1.27 mm , p < 0.001 ) .
RESULTS	Restenosis ( > or = 50 % diameter stenosis at follow-up ) occurred in 34 % of patients assigned to stenting and in 55 % of patients assigned to angioplasty ( p < 0.001 ) .
RESULTS	At 1 year , event-free survival was achieved in 78 % of the stent group and in 67 % of the angioplasty group ( p = 0.019 ) .
CONCLUSIONS	These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3 mm .

###20169196
BACKGROUND	Successful object manipulation relies on the ability to form and retrieve sensorimotor memories of digit forces and positions used in previous object lifts .
BACKGROUND	Past studies of patients affected by Parkinson 's disease ( PD ) have revealed that the basal ganglia play a crucial role in the acquisition and/or retrieval of sensorimotor memories for grasp control .
BACKGROUND	Whereas it is known that PD impairs anticipatory control of digit forces during grasp , learning deficits associated with the planning of digit placement have yet to be explored .
BACKGROUND	This question is motivated by recent work in healthy subjects revealing that anticipatory control of digit placement plays a crucial role for successful manipulation .
RESULTS	We asked ten PD patients off medication and ten age-matched controls to reach , grasp and lift an object whose center of mass ( CM ) was on the left , right or center .
RESULTS	The only task requirement was to minimize object roll during lift .
RESULTS	The CM remained the same across consecutive trials ( blocked condition ) or was altered from trial to trial ( random condition ) .
RESULTS	We hypothesized that impairment of the basal ganglia-thalamo-cortical circuits in PD patients would reduce their ability to anticipate digit placement appropriate to the CM location .
RESULTS	Consequently , we predicted that PD patients would exhibit similar digit placement in the blocked vs. random conditions and produce larger peak object rolls than that of control subjects .
RESULTS	In the blocked condition , PD patients exhibited significantly weaker modulation of fingertip contact points to CM location and larger object roll than controls ( p < 0.05 and p < 0.01 , respectively ) .
RESULTS	Nevertheless , both controls and PD patients minimized object roll more in the blocked than in the random condition ( p < 0.01 ) .
CONCLUSIONS	Our findings indicate that , even though PD patients may have a residual ability of anticipatory control of digit contact points and forces , they fail to implement a motor plan with the same degree of effectiveness as controls .
CONCLUSIONS	We conclude that intact basal ganglia-thalamo-cortical circuits are necessary for successful sensorimotor learning of both grasp kinematics and kinetics required for dexterous hand-object interactions .

###16290907
OBJECTIVE	Previous studies using standard interferon and ribavirin combination therapy suggested that patients infected with HCV-1 and a low pretreatment HCV-RNA level can be treated for 24 weeks without compromising sustained virologic response rates .
OBJECTIVE	The aim of the present study was to investigate this schedule in the era of pegylated interferon-alpha plus ribavirin .
METHODS	Patients chronically infected with HCV-1 ( n = 235 ) and a screening viremia < or = 600,000 IU/mL ( real-time PCR ) were treated with peginterferon alfa-2b 1.5 microg/kg subcutaneously once weekly plus ribavirin 800-1400 mg/day based on body weight for 24 weeks .
RESULTS	End-of-treatment and sustained virologic response rates were 80 and 50 % , respectively .
RESULTS	The 48-week historical control ( Manns et al. , Lancet 2001 ; 358:958 -65 ) had similar end-of-treatment ( 74 % ) but higher sustained virologic response rates ( 71 % ) .
RESULTS	This difference was due to a high virologic relapse rate after 24 weeks of therapy ( 37 % ) compared with the historical control ( 4 % ) .
RESULTS	A subset of patients who had undetectable serum HCV-RNA at treatment week 4 , however , achieved similar sustained virologic response rate ( 89 % ) as in the control group ( 85 % ) .
CONCLUSIONS	HCV-1 infected patients with a low baseline HCV-RNA concentration who become HCV-RNA negative at week 4 may be treated for 24 weeks without compromising sustained virologic response rates .

###15225178
BACKGROUND	The need to withhold acid suppression therapy while awaiting urea breath test results is a common clinical problem in symptomatic patients .
BACKGROUND	It is unclear at present if the dose or type of proton pump inhibitor or the type of test meal govern the apparent masking effect of proton pump inhibitors on the urea breath test .
OBJECTIVE	To prospectively evaluate Helicobacter pylori detection rates during treatment with four different proton pump inhibitors , utilizing a high-dose citric acid-based 13C urea breath test .
METHODS	Patients positive for Helicobacter pylori by urea breath test were randomized to receive either omeprazole 20 mg/day , pantoprazole 40 mg/day , lansoprazole 30 mg/day or esomeprazole 40 mg/day for 14 days .
METHODS	A repeat breath test was performed on day 14 of treatment .
RESULTS	One hundred and seventy-nine patients , mean age 45.8 + / - 16.8 , completed the study .
RESULTS	Treatment with omeprazole or pantoprazole prior to urea breath test ( UBT ) was associated with low false negative results , while lansoprazole and esomeprazole caused clinically unacceptable high false negative rates ( pantoprazole 2.2 % vs. lansoprazole 16.6 % , P = 0.02 , vs. esomeprazole 13.6 % , P = 0.05 ; omeprazole 4.1 % vs. lansoprazole 16.6 % , P = 0.05 ) .
CONCLUSIONS	Proton pump inhibitor-induced false negative results on high-dose citric acid based urea breath test vary with the type of proton pump inhibitor used .
CONCLUSIONS	Selection of the appropriate test meal and proton pump inhibitor may allow symptomatic individuals to continue their proton pump inhibitors prior to performing a urea breath test .

###16212588
OBJECTIVE	To compare effects of 3 commonly used perioperative analgesic protocols ( epidural injection , intra-articular injection , and intravenous [ IV ] injection ) for management of postoperative pain in dogs after tibial plateau leveling osteotomy ( TPLO ) .
METHODS	Prospective , randomized clinical trial .
METHODS	Fifty-six healthy dogs with naturally occurring cranial cruciate ligament rupture .
METHODS	Dogs were premedicated with IV hydromorphone and acepromazine and were randomly assigned to receive either E ( preoperative epidural injection with morphine and bupivacaine ) , IA ( pre - and postoperative intra-articular injections of bupivacaine ) , or C ( neither epidural morphine and bupivacaine , nor intra-articular bupivacaine ) .
METHODS	All dogs were administered hydromorphone ( 0.05 mg/kg IV ) at extubation and as needed to maintain comfort postoperatively .
METHODS	Patients were observed and monitored continuously for 24 hours and discomfort was assessed using visual analog pain scores ( VASs ) , multifactorial pain scores ( MPSs ) , and response to a pressure nociceptive threshold ( PNT ) measuring device .
METHODS	Time to 1st dose and the total doses of hydromorphone required to achieve adequate comfort for each dog were recorded .
RESULTS	No differences in measured indices of postoperative pain were observed between dogs of each treatment group ; VAS ( P = .190 ) , MPS ( P = .371 ) , and PNT ( P = .160 ) .
RESULTS	Time to 1st analgesic intervention was longer for Group E compared with Group C ( P = .005 ) and longer for Group IA compared with Group C ( P = .032 ) .
RESULTS	Although time to 1st intervention between Groups E and IA were longer for Group E , differences were not significant .
RESULTS	To provide an adequate level of comfort , more analgesic interventions were administered to dogs in Group C compared with dogs in group E ( P = .015 ) .
RESULTS	On average , more hydromorphone was administered to Group C compared with Group IA ( P = .072 ) and to Group IA compared with Group E ( P = .168 ) , but statistical significance was not reached for these data .
CONCLUSIONS	In this study population , significant differences were seen in time to 1st hydromorphone dose between Groups E and IA compared with Group C.
CONCLUSIONS	As well , more supplemental analgesia was administered to Group C compared with Group E to maintain the same level of postoperative comfort .
CONCLUSIONS	Although differences between Groups E and IA tended to favor the epidural group , differences were minimal and not statistically significant .
CONCLUSIONS	Our results suggest that regardless of analgesic protocol , measured indices of pain in dogs after TPLO can be minimized if dogs are continuously observed and appropriately supplemented with parenteral opioids .
CONCLUSIONS	However , the frequency of postoperative opioid dosing can be minimized and may be a factor when contemplating supplementary use of epidural or intra-articular injections as part of a balanced analgesic approach .

###10960936
OBJECTIVE	Visual feedback related to weight distribution and center-of-pressure positioning has been shown to be effective in increasing stance symmetry following stroke , although it is not clear whether functional balance ability also improves .
OBJECTIVE	This study compared the relative effectiveness of visual feedback training of center-of-gravity ( CoG ) positioning with conventional physical therapy following acute stroke .
METHODS	Forty-six people who had strokes within 80 days before the study , resulting in unilateral hemiparesis , and who were in need of balance retraining participated .
METHODS	Initially , subjects were randomly assigned to visual feedback or conventional physical therapy groups for balance retraining until 16 subjects per group were recruited .
METHODS	The next 14 subjects were assigned to a control group .
METHODS	All subjects received physical therapy and occupational therapy ( regular therapy ) 2 hours a day , and subjects in the 2 experimental groups received additional balance training 30 minutes a day until discharge .
METHODS	The visual feedback group received information about their CoG position as they shifted their weight during various activities .
METHODS	The conventional therapy group received verbal and tactile cues to encourage symmetrical stance and weight shifting .
METHODS	Static ( postural sway ) and activity-based measures of balance ( Berg Balance Scale , gait speed , and the Timed `` Up & Go '' Test ) were contrasted across the 3 groups at baseline , at discharge , and at 1 month following discharge using an analysis of variance for repeated measures .
RESULTS	All groups demonstrated marked improvement over time for all measures of balance ability , with the greatest improvements occurring in the period from baseline to discharge .
RESULTS	No between-group differences were detected in any of the outcome measures .
CONCLUSIONS	Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke .

###17592907
OBJECTIVE	To assess the efficacy and safety of aripiprazole versus placebo as adjunctive treatment to standard antidepressant therapy ( ADT ) in patients with major depressive disorder ( MDD ) who showed an incomplete response to 1 prospective and 1 to 3 historical courses of ADT within the current episode .
METHODS	The study comprised a 7 - to 28-day screening phase , an 8-week prospective treatment phase , and a 6-week double-blind treatment phase .
METHODS	Patients with DSM-IV-TR-defined MDD were enrolled between June 16 , 2004 , and April 27 , 2006 .
METHODS	During prospective treatment , patients received ADT : escitalopram , fluoxetine , paroxetine controlled-release , sertraline , or venlafaxine extended-release , each with single-blind , adjunctive placebo .
METHODS	Incomplete responders continued ADT and were randomly assigned to double-blind , adjunctive placebo or adjunctive aripiprazole ( 2-15 mg/day with fluoxetine or paroxetine ; 2-20 mg/day with all others ) .
METHODS	The primary efficacy endpoint was the mean change from end of prospective treatment to end of double-blind treatment ( week 14 , last observation carried forward ) in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ( analysis of covariance ) .
RESULTS	A total of 178 patients were randomly assigned to adjunctive placebo and 184 to adjunctive aripiprazole .
RESULTS	Baseline demographics were similar between groups ( mean MADRS total score of 26.0 ) .
RESULTS	Mean change in MADRS total score was significantly greater with adjunctive aripiprazole ( -8.8 ) than adjunctive placebo ( -5.8 ; p < .001 ) .
RESULTS	Adverse events ( AEs ) that occurred in > or = 10 % of patients with adjunctive placebo or adjunctive aripiprazole were akathisia ( 4.5 % vs. 23.1 % ) , headache ( 10.8 % vs. 6.0 % ) , and restlessness ( 3.4 % vs. 14.3 % ) .
RESULTS	Discontinuations due to AEs were low with adjunctive placebo ( 1.7 % ) and adjunctive aripiprazole ( 2.2 % ) ; only 1 adjunctive aripiprazole-treated patient discontinued due to akathisia .
CONCLUSIONS	In patients with MDD who showed an incomplete response to ADT , adjunctive aripiprazole was efficacious and well tolerated .
BACKGROUND	ClinicalTrials.gov identifier NCT00095823 .

###1423177
BACKGROUND	A randomized adjuvant trial was conducted from October 1982 to January 1985 to evaluate the addition of tamoxifen ( TAM ) to combination chemotherapy with perioperative mitomycin C ( MMC ) and ftorafur ( FT ) for patients with estrogen receptor ( ER ) - positive tumors and the addition of PSK , a biologic response modifier , to MMC+FT chemotherapy for patients with ER-negative tumors in operable Stage IIA , IIB , and IIIA cancer .
BACKGROUND	The doses used were 20 mg of oral TAM daily , 600 mg of oral FT daily , and 3 g of oral PSK daily for 2 years .
BACKGROUND	Intravenous MMC ( 13 mg/m2 ) was given on the day of operation .
METHODS	A total of 967 patients were entered and randomized by stratification based on ER status and staging ( 1978 International Union Against Cancer [ UICC ] criteria at the time of trial execution ) .
METHODS	Of 967 patients , 914 ( 94.5 % ) were evaluable .
METHODS	At 5-year follow-up , significant prolonged overall survival ( OS ) and relapse-free survival ( RFS ) times were seen with the addition of TAM in patients with ER-positive and Stage IIIA T3N0 cancer ( 1987 UICC-American Joint Committee on Cancer [ AJCC ] criteria ) ; however , no significant survival benefit from TAM was seen in patients with ER-positive and Stage IIA T2N1 cancer .
METHODS	There was no significant difference between regimens , with or without PSK , in patients with ER-negative disease .
RESULTS	Results of subset analyses suggested a benefit from TAM in postmenopausal patients with ER-positive and Stage IIA T2N1 cancer and a benefit from PSK in patients with node-negative , ER-negative , and Stage IIA T2N1 cancer .
CONCLUSIONS	The 5-year results of the current trial showed a survival advantage by the addition of TAM to chemotherapy in patients with ER-positive and Stage IIIA T3N0 cancer .

###18281407
OBJECTIVE	Systems Training for Emotional Predictability and Problem Solving ( STEPPS ) is a 20-week manual-based group treatment program for outpatients with borderline personality disorder that combines cognitive behavioral elements and skills training with a systems component .
OBJECTIVE	The authors compared STEPPS plus treatment as usual with treatment as usual alone in a randomized controlled trial .
METHODS	Subjects with borderline personality disorder were randomly assigned to STEPPS plus treatment as usual or treatment as usual alone .
METHODS	Total score on the Zanarini Rating Scale for Borderline Personality Disorder was the primary outcome measure .
METHODS	Secondary outcomes included measures of global functioning , depression , impulsivity , and social functioning ; suicide attempts and self-harm acts ; and crisis utilization .
METHODS	Subjects were followed 1 year posttreatment .
METHODS	A linear mixed-effects model was used in the analysis .
RESULTS	Data pertaining to 124 subjects ( STEPPS plus treatment as usual [ N = 65 ] ; treatment as usual alone [ N = 59 ] ) were analyzed .
RESULTS	Subjects assigned to STEPPS plus treatment as usual experienced greater improvement in the Zanarini Rating Scale for Borderline Personality Disorder total score and subscales assessing affective , cognitive , interpersonal , and impulsive domains .
RESULTS	STEPPS plus treatment as usual also led to greater improvements in impulsivity , negative affectivity , mood , and global functioning .
RESULTS	These differences yielded moderate to large effect sizes .
RESULTS	There were no differences between groups for suicide attempts , self-harm acts , or hospitalizations .
RESULTS	Most gains attributed to STEPPS were maintained during follow-up .
RESULTS	Fewer STEPPS plus treatment as usual subjects had emergency department visits during treatment and follow-up .
RESULTS	The discontinuation rate was high in both groups .
CONCLUSIONS	STEPPS , an adjunctive group treatment , can deliver clinically meaningful improvements in borderline personality disorder-related symptoms and behaviors , enhance global functioning , and relieve depression .

###20112246
BACKGROUND	The study evaluated the efficacy of an indicated prevention program for adolescent depression .
METHODS	Fifty-seven adolescents with elevated depression symptoms were randomized to receive Interpersonal Psychotherapy-Adolescent Skills Training ( IPT-AST ) or school counseling ( SC ) .
METHODS	Hierarchical linear modeling examined differences in rates of change in depression symptoms and overall functioning and analysis of covariance examined mean differences between groups .
METHODS	Rates of depression diagnoses in the 18-month follow-up period were compared .
RESULTS	Adolescents in IPT-AST reported significantly greater rates of change in depression symptoms and overall functioning than SC adolescents from baseline to post-intervention .
RESULTS	At post-intervention , IPT-AST adolescents reported significantly fewer depression symptoms and better overall functioning .
RESULTS	During the follow-up phase , rates of change slowed for the IPT-AST adolescents , whereas the SC adolescents continued to show improvements .
RESULTS	By 12-month follow-up , there were no significant mean differences in depression symptoms or overall functioning between the two groups .
RESULTS	IPT-AST adolescents reported significantly fewer depression diagnoses in the first 6 months following the intervention but by 12-month follow-up the difference in rates of diagnoses was no longer significant .
CONCLUSIONS	IPT-AST leads to an immediate reduction in depression symptoms and improvement in overall functioning .
CONCLUSIONS	However , the benefits of IPT-AST are not consistent beyond the 6-month follow-up , suggesting that the preventive effects of the program in its current format are limited .
CONCLUSIONS	Future studies are needed to examine whether booster sessions lengthen the long-term effects of IPT-AST .

###14522414
BACKGROUND	Tissue factor ( TF ) , the main trigger of coagulation is important in the propagation of cardiovascular diseases .
BACKGROUND	Based on an in vitro study , we hypothesised that enalapril may blunt the endotoxin-induced , TF-triggered coagulation in humans .
METHODS	In a randomised , controlled trial , 30 healthy male volunteers received 2 ng/kg of lipopolysaccharide ( LPS ) after pre-treatment with placebo or enalapril for 5 days or with enalapril 2 h before LPS infusion .
RESULTS	Infusion of LPS increased interleukin-6 levels 400 fold , and induced a 10-fold increase in prothrombin fragment , a fourfold increase in D-dimer , and a fivefold increase in plasmin-antiplasmin complexes .
RESULTS	However , pre-treatment with enalapril did not blunt LPS-induced coagulation .
CONCLUSIONS	Our trial provides evidence against a modulatory role of angiotensin converting enzyme in LPS-induced , TF-triggered coagulation .

###23034962
BACKGROUND	Limited evidence from human and animal studies has suggested that vitamin K has a potentially beneficial role in glucose metabolism and insulin resistance .
OBJECTIVE	We analyzed the cross-sectional and longitudinal associations between dietary phylloquinone intake and type 2 diabetes in elderly subjects at high cardiovascular risk .
METHODS	Cross-sectional associations were tested in 1925 men and women in the Prevention with the Mediterranean Diet trial .
METHODS	A longitudinal analysis was conducted on 1069 individuals free of diabetes at baseline ( median follow-up : 5.5 y ) .
METHODS	Biochemical and anthropometric variables were obtained yearly .
METHODS	Dietary intake was collected during each annual visit by using a food-frequency questionnaire , and phylloquinone intake was estimated by using the USDA database .
METHODS	The occurrence of type 2 diabetes during follow-up was assessed by using American Diabetes Association criteria .
RESULTS	Dietary phylloquinone at baseline was significantly lower in subjects who developed type 2 diabetes during the study .
RESULTS	After adjustment for potential confounders , risk of incident diabetes was 17 % lower for each additional intake of 100 g phylloquinone/d .
RESULTS	Moreover , subjects who increased their dietary intake of vitamin K during the follow-up had a 51 % reduced risk of incident diabetes compared with subjects who decreased or did not change the amount of phylloquinone intake .
CONCLUSIONS	We conclude that dietary phylloquinone intake is associated with reduced risk of type 2 diabetes .
CONCLUSIONS	This trial was registered at http://www.controlled-trials.com as ISRCTN35739639 .

###14687475
OBJECTIVE	To delineate the influence of transcutaneous electrical nerve stimulation ( TENS ) on heat pain threshold and vibration threshold in human .
METHODS	Twenty healthy , young subjects , aged from 20 to 39 , participated in the study .
METHODS	They were randomly allocated into either TENS or placebo group .
METHODS	Thirty minutes of conventional TENS ( 200 micro s pulses at 100 Hz and 2 - 3 times sensory threshold ) or placebo stimulation was applied to the acupuncture points ( LI4 ) on each subject 's left hand .
METHODS	Heat pain and vibration thresholds were measured using Medoc TSA-2001 and VSA-3000 respectively on the thenar eminence of each subject 's left hand .
METHODS	These assessments were done at 30 , 20 and 10 minutes before and 0 , 10 , 20 , 30 , 40 and 50 minutes after 30 minutes of TENS or placebo treatment .
RESULTS	This study showed a significant increase in heat pain threshold by 0.81 degrees C and 1.54 degrees C respectively at 0 ( P = 0.002 ) and 20 minutes ( P = 0.004 ) after 30 minutes of TENS application to the LI4 acupoint of young healthy subjects , compared with placebo stimulation .
RESULTS	Interestingly , no significant difference in vibration threshold was found between the TENS and placebo groups .
CONCLUSIONS	The effect of TENS on the acupoint is to reduce pain but not tactile ( specifically vibration ) sensibility .

###11403976
BACKGROUND	GABA receptor-modifying neurosteroids may play a role in premenstrual syndrome ( PMS ) .
BACKGROUND	The peripheral benzodiazepine receptor ( PBR ) both regulates the formation of neurosteroids and is , in animals , regulated by ovarian steroids .
BACKGROUND	Alterations in PBR density have been observed in association with several psychiatric disorders .
METHODS	We examined the effects of gonadal steroids on lymphocytic PBR density in nine women with prospectively confirmed PMS and nine controls .
METHODS	PBR densities were measured during three pharmacologically controlled conditions : gonadotropin releasing hormone agonist ( Lupron ) - induced hypogonadism , Lupron plus estradiol , and Lupron plus progesterone replacement .
METHODS	Blood samples were obtained after six weeks of Lupron alone and after 3-4 weeks of estradiol and progesterone replacement .
RESULTS	No significant hormone state-related changes in PBR density were observed ( ANOVA-R : phase-F ( 2,32 ) = 1.5 , P = 0.2 ) .
RESULTS	Despite mood symptom development in the subjects with PMS , PBR density did not differ in women with PMS compared to controls across hormonal states ( ANOVA-R : F ( 1,16 ) = 0.6 , P = 0.4 ) .
CONCLUSIONS	PBR densities are not altered in women with PMS and are not changed significantly by selective gonadal steroid administration .
CONCLUSIONS	Changes in PBR density would not appear to underlie the differential sensitivity to the mood destabilizing effects of ovarian steroids in PMS .

###18567824
OBJECTIVE	Ghrelin and peptide YY ( PYY ) are both hormones derived from the gastrointestinal tract involved in appetite regulation .
OBJECTIVE	The cholinergic part of the vagal nerve is involved in the regulation of glucose and insulin .
OBJECTIVE	The aim of this study was to examine the effects of the cholinergic antagonist atropine on ghrelin , PYY , glucose , and insulin under basal conditions and after meal ingestion in lean and obese subjects .
METHODS	Eight lean and eight obese subjects were included in a randomized , double-blind , placebo-controlled crossover study with 4 study days in randomized order ( atropine/placebo + / - breakfast ) .
METHODS	Plasma ghrelin , PYY , insulin , and glucose were measured .
METHODS	Hunger and satiety feelings were rated on a 10-cm visual analog scale .
RESULTS	In lean individuals , atropine led to a decrease in ghrelin concentrations comparable and nonadditive with breakfast ingestion and a significant decrease in both basal and meal-induced PYY concentrations .
RESULTS	In obese subjects , atropine did not significantly change ghrelin or PYY concentrations , whereas it induced a comparable increase in heart rate and meal-induced glucose concentrations in the two study groups .
RESULTS	Only lean , not obese , subjects experienced sustained feelings of satiety after breakfast .
CONCLUSIONS	The impaired cholinergic regulation of the postprandial drop in ghrelin concentrations and rise in PYY concentrations might be part of the deregulated food intake in obese subjects .

###22498844
OBJECTIVE	Brief , effective models of patient genetic education are needed for common , complex diseases .
OBJECTIVE	Using Alzheimer disease as a model , we compared participants ' risk knowledge and recall in extended versus condensed education protocols .
METHODS	A four-site randomized clinical trial enrolled 280 first-degree relatives of individuals with Alzheimer disease ( mean age = 58 years , 71 % female ) ; each received lifetime Alzheimer disease risk information ( range : 13-74 % ) that incorporated apolipoprotein E genotype .
METHODS	In the condensed protocol , participants received an educational brochure in place of an in-person education session .
METHODS	Outcomes were assessed at 6 weeks and 6 months following risk disclosure .
RESULTS	The condensed protocol required less clinician time than the extended protocol ( mean = 34min vs. 77min ) .
RESULTS	The groups did not differ on recall of apolipoprotein E genotype or lifetime risk , and most participants in both groups recalled and retained this information over time .
RESULTS	Both groups showed improvement from baseline in Alzheimer disease risk knowledge ( e.g. , understanding the magnitude of apolipoprotein E genotype effect on risk ) .
CONCLUSIONS	A condensed protocol for communicating genetic risk for Alzheimer disease achieved similar educational results as an extended protocol in this study .
CONCLUSIONS	Further research should explore the efficacy of brief genetic education protocols for complex diseases in diverse populations .

###10063814
OBJECTIVE	The purpose of this study was to examine the effect of a decreased body core temperature before a simulated portion of a triathlon ( swim ,15 min ; bike , 45 min ) and examine whether precooling could attenuate thermal strain and increase subjective exercise tolerance in a warm environment ( 26.6 degrees C/60 % relative humidity ( rh ) ) .
METHODS	Six endurance trained triathletes ( 28 + / -2 yr , 8.2 + / -1.7 % body fat ) completed two randomly assigned trials 1 wk apart .
METHODS	The precooling trial ( PC ) involved lowering body core temperature ( -0.5 degrees C rectal temperature , Tre ) in water before swimming .
METHODS	The control trial ( CON ) was identical except no precooling was performed .
METHODS	Water temperature and environmental conditions were maintained at 25.6 degrees C and 26.6 degrees C/60 % rh , respectively , throughout all testing .
RESULTS	Mean time to precool was 31 + / -8 min and average time to reach baseline Tre during cycling was 9 + / -7 min .
RESULTS	Oxygen uptake ( VO2 ) , HR , skin temperature ( Tsk ) , Tre , RPE , and thermal sensation ( TS ) were recorded following the swim segment and throughout cycling .
RESULTS	No significant differences in mean body ( Tb ) or Tsk were noted between PC and CON , but a significant difference ( P < 0.05 ) in Tre between treatments was noted through the early phases of cycling .
RESULTS	No significant differences were reported in HR , VO2 , RPE , TS , or sweat rate ( SR ) between treatments .
RESULTS	Body heat storage ( S ) was negative following swimming in both PC ( -92 + / -6 W x m2 ) and CON ( -66 + / -9 W x m2 ) .
RESULTS	A greater S occurred in PC ( 109 + / -6 W x m2 ) vs CON ( 79 + / -4 W x m2 ) during cycling ( P < 0.05 ) .
CONCLUSIONS	Precooling attenuated the rise in Tre , but this effect was transient .
CONCLUSIONS	Therefore , precooling is not recommended before a triathlon under similar environmental conditions .

###16632399
OBJECTIVE	In 1996 , a multicenter randomized study comparing after breast-conservative surgery , sequential vs concurrent adjuvant chemotherapy ( CT ) with radiation therapy ( RT ) was initiated ( ARCOSEIN study ) .
OBJECTIVE	Seven hundred sixteen patients were included in this trial .
OBJECTIVE	After a median follow-up of 6.7 ( 4.3-9 ) years , we decided to prospectively evaluate the late effects of these two strategies .
METHODS	A total of 297 patients were asked to follow-up from the five larger including institutions .
METHODS	Seventy-two percent ( 214 patients ) were eligible for late toxicity .
METHODS	After breast-conserving surgery with axillary dissection , patients were treated either with sequential treatment with CT first followed by RT ( arm A ) or CT administered concurrently with RT ( arm B ) .
METHODS	In all patients , CT regimen combined mitoxantrone ( 12 mg/m ( 2 ) ) , 5-FU ( 500 mg/m ( 2 ) ) , and cyclophosphamide ( 500 mg/m ( 2 ) ) , 6 cycles ( day 1-day 21 ) .
METHODS	In arm B , patients received concurrently the first 3 cycles of CT with RT. .
METHODS	In arm A , RT started 3 to 5 weeks after the 6th cycle of CT. .
METHODS	Conventional RT was delivered to the whole breast using a 2 Gy-fraction protocol to a total dose of 50 Gy ( + / - boost to the primary tumour bed ) .
METHODS	The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist according to the LENT-SOMA scale .
METHODS	Skin pigmentation was also evaluated using a personal 5-points scoring system ( excellent , good , moderate , poor , very poor ) .
RESULTS	Among the 214 evaluated patients , 107 were treated in each arm .
RESULTS	The two populations were homogeneous for patients ' , tumors ' and treatment characteristics .
RESULTS	Subcutaneous fibrosis ( SF ) , telengectasia ( T ) , skin pigmentation ( SP ) , and breast atrophy ( BA ) were significantly increased in arm B. Twenty patients experienced grade superior or equal to 2 ( SF ) in arm B vs five in arm A ( P = 0.003 ) .
RESULTS	Twenty-five and seven patients showed grade superior or equal to 2 ( T ) in arm B and A , respectively ( P = 0.001 ) .
RESULTS	Forty-four and twenty patients showed grade superior or equal to 2 ( BA ) in arm B and A , respectively ( P = 0.0006 ) .
RESULTS	Thirty patients experienced grade superior or equal to 3 ( SP ) in arm B vs fifteen in arm A ( P = 0.02 ) .
RESULTS	No statistical difference was observed between the two arms concerning grade superior or equal to 2 pain , breast oedema , and lymphoedema .
RESULTS	No deaths were caused by late toxicity .
CONCLUSIONS	Following breast conserving surgery , the concurrent use of CT with RT is significantly associated with an increase incidence of grade 2 or greater late side effects .

###10360858
BACKGROUND	Ropivacaine may be useful for intravenous regional anesthesia , but its anesthetic effectiveness and toxicity have not been evaluated .
METHODS	Two doses of ropivacaine ( 1.2 and 1.8 mg/kg ) and one dose of lidocaine ( 3 mg/kg ) were compared for intravenous regional anesthesia in 15 volunteers .
METHODS	An arm tourniquet was inflated for 30 min after injection and then deflated in two cycles .
METHODS	Sensory block was measured by response to touch , cold , pinprick , and transcutaneous electric stimulation , and motor function was measured by hand grip strength and muscle power .
METHODS	Median , ulnar , radial , and musculocutaneous nerve functions were tested before local anesthetic injection and then at 5-min intervals until blocks resolved .
METHODS	The plasma ropivacaine and lidocaine concentrations were determined from arterial and venous blood samples drawn from the unanesthetized arm .
RESULTS	Sensory and motor blocks were complete within 25 min and 30 min , respectively , in all three treatment groups .
RESULTS	However , recovery of sensory and motor block after tourniquet release was slowest in the high-dose ropivacaine group .
RESULTS	Anesthesia to pinprick and transcutaneous electric stimulation was sustained in all the volunteers in the high-dose ropivacaine group for 55 min and 85 min , respectively , whereas complete recovery was observed in the lidocaine group ( P = 0.008 ) and partial recovery in the low-dose ropivacaine group ( P < 0.05 ) during the same period .
RESULTS	Motor block also was sustained in the high-dose ropivacaine group for 70 min , which was significantly longer than in the lidocaine group ( P < 0.05 ) .
RESULTS	All volunteers ( five of five ) given lidocaine and one volunteer given high-dose ropivacaine reported light-headedness and hearing disturbance during tourniquet release when the arterial plasma lidocaine and ropivacaine concentrations were 4.7 + / -2.1 microg/ml ( mean ) and 2.7 micro/ml , respectively .
CONCLUSIONS	Compared with lidocaine , intravenous regional anesthesia with ropivacaine appears to be comparable but has longer-lasting residual anesthesia .

###25092553
OBJECTIVE	The purpose of this study was to assess the effectiveness of global postural reeducation ( GPR ) relative to segmental exercises ( SE ) in the treatment of scapular dyskinesis ( SD ) associated with neck pain .
METHODS	Participants with SD and neck pain ( n = 30 ) aged 18 to 65 years were randomly assigned to one of two groups : GPR and SE ( stretching exercises ) .
METHODS	The upper extremity was assessed using the Disabilities of the Arm , Shoulder , and Hand questionnaire ; function of the neck was estimated using the Neck Disability Index ; pain severity was measured using a visual analogical scale ; and health-related quality of life was assessed using the Short Form-12 .
METHODS	Assessments were conducted at baseline and after 10 weekly sessions ( 60 minutes each ) .
METHODS	The significance level adopted was < .05 .
RESULTS	For pre-post treatment comparisons , GPR was significantly associated with improvements in function of neck and upper extremities , pain , and physical and mental domains of quality of life ( P < .05 ) .
RESULTS	Segmental exercises improved function of upper extremities and of the neck and severity of pain ( P < .05 ) .
RESULTS	When contrasting groups , GPR was significantly superior to SE in improving pain and physical domains of the quality of life .
CONCLUSIONS	This study showed that GPR and SE had similar effects on function of the neck and upper extremity in patients with SD associated with neck pain .
CONCLUSIONS	When comparing groups , GPR was superior to SE in improving pain and quality of life .

###24262684
OBJECTIVE	To determine if the use of a Bakri balloon at cesarean delivery ( CD ) for placenta previa is associated with a reduced need for additional surgical or pharmacologic measures and less blood loss than usual practices .
METHODS	In a randomized controlled trial , 52 women undergoing CD for placenta previa were randomly allocated 1:1 into an intervention arm ( prophylactic Bakri balloon immediately following placental delivery ) or a control arm ( use of any usual surgical/pharmacologic measures to achieve hemostasis ) .
METHODS	The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .
RESULTS	Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .
RESULTS	The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .
CONCLUSIONS	The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .
CONCLUSIONS	Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .

###25773557
OBJECTIVE	To estimate the effect of sequence on response precision and response behavior in health valuation studies .
METHODS	Time trade-off ( TTO ) and paired comparison responses from six health valuation studies-four US , one Spanish , and one Dutch-were examined ( 22,225 respondents ) to test whether task sequence influences response precision ( e.g. , rounding ) , response changes , and median response times .
METHODS	Each study used a computer-based instrument that randomized task sequence among a national sample of adults , age 18 years or older , from the general population .
RESULTS	For both TTO and paired comparisons , median response times decreased with sequence ( i.e. , learning ) , but tended to flatten after the first three tasks .
RESULTS	Although the paired comparison evidence demonstrated that sequence had no effect on response precision , the frequency of rounded TTO responses ( to either 1-year or 5-year units ) increased with sequence .
CONCLUSIONS	Based on these results , randomizing or reducing the number of paired comparison tasks does not appear to influence response precision ; however , generalizability , practicality , and precautionary considerations remain .
CONCLUSIONS	Overall , participants learned to respond efficiently within the first three tasks and did not resort to satisficing , but may have rounded their TTO responses .

###15290731
OBJECTIVE	To compare etanercept-induced improvement in disability of patients with recent onset of rheumatoid arthritis ( RA ) to that of patients with established RA .
METHODS	Health Assessment Questionnaire ( HAQ ) scores were collected over 3 years in 2 groups of patients with RA who were treated with etanercept .
METHODS	The first group consisted of 207 patients with recent onset RA ( mean duration of 1 year ) who had not previously received methotrexate , and the second group consisted of 464 patients with established RA ( mean duration of 12 years ) who had failed one or more disease-modifying antirheumatic drugs .
RESULTS	Baseline demographics and disease characteristics were similar in the 2 groups , except for HAQ scores and C-reactive protein levels , which were higher in the established RA group .
RESULTS	Patients in both groups showed rapid and sustained clinical responses with etanercept therapy , but patients with recent onset RA showed significantly greater improvement in HAQ scores compared with patients with established RA .
RESULTS	The difference in magnitude of HAQ score improvement between groups was observed as early as week 2 after initiation of etanercept and persisted throughout the 3-year time frame .
RESULTS	At year 3 , significantly more patients with recent onset RA had a HAQ score of zero ( 26 % ) versus those with established RA ( 14 % , p = 0.0095 ) .
CONCLUSIONS	Although etanercept therapy significantly improved disability scores in both groups , patients with recent onset of RA showed greater benefit in HAQ scores than patients with established RA .
CONCLUSIONS	These results support prompt treatment of RA at an early stage of disease to minimize patient disability .

###25605698
OBJECTIVE	To compare local infiltration of dexamethasone to intravenous injection for postoperative pain and recovery after tonsillectomy .
METHODS	Prospective , randomized study .
METHODS	Second Affiliated Hospital of Harbin Medical University .
METHODS	Children ( n = 240 , American Society of Anesthesiologists [ ASA ] classes I-II , aged 5-10 y ) scheduled for tonsillectomy were randomly and equally assigned to 3 groups : DEX-IV , for intravenous injection of dexamethasone ( 0.5 mg/kg , maximum dose 24 mg ) ; DEX-INF , given the same amount of dexamethasone by local infiltration to the upper middle and lower poles of the tonsils ; and a control group not given dexamethasone .
METHODS	Postoperative pain was scored at intervals from 30 minutes to 24 hours .
METHODS	The time to first administration of analgesic and average consumption of analgesic , times to first oral water and solid food intake , and incidence rates of nausea and vomiting were evaluated .
RESULTS	From postoperative 1 to 16 hours , the DEX-INF group had significantly lower pain scores than did the DEX-IV group , and the time to first analgesic and average consumption of analgesic were also significantly lower .
RESULTS	The times to first oral water and food intake in the DEX-INF group were significantly shorter than in the DEX-IV group .
RESULTS	The incidence of nausea and vomiting in the DEX-INF group was higher than that of the DEX-IV group .
CONCLUSIONS	Local infiltration of dexamethasone was more effective than systemic administration to decrease pain and time to food intake , but the antiemetic effect was less .
BACKGROUND	ChiCTR-TRC-13003535 .

###23106760
OBJECTIVE	This study examined the relation of process variables to the outcome of group drug counseling , a commonly used community treatment , for cocaine dependence .
METHODS	Videotaped group drug counseling sessions from 440 adult patients ( 23 % female , 41 % minority ) were rated for member alliance , group cohesion , participation , self-disclosure , as well as positive and non-positive feedback and advice during the 6-month treatment of cocaine dependence .
METHODS	Average , session-level , and slopes of process scores were evaluated .
METHODS	Primary outcomes were monthly cocaine use ( days using out of 30 ) , next session cocaine use , and duration of sustained abstinence from cocaine .
METHODS	Secondary outcomes were endorsement of 12-step philosophy and beliefs about substance abuse .
RESULTS	More positive alliances ( with counselor ) were associated with reductions in days using cocaine per month and next-session cocaine use and increases in endorsement of 12-step philosophy .
RESULTS	Patient self-disclosure about the past and degree of participation in the group were generally not predictive of group drug counseling outcomes .
RESULTS	More advice from counselor and other group members were consistently associated with poorer outcomes in all categories .
RESULTS	Individual differences in changes in process variables over time ( linear slopes ) were generally not predictive of treatment outcomes .
CONCLUSIONS	Some group behaviors widely believed to be associated with outcome , such as self-disclosure and participation , were not generally predictive of outcomes of group drug counseling , but alliance with the group counselor was positively associated , and advice giving was negatively associated , with the outcome of treatments for cocaine dependence .

###17187683
BACKGROUND	An estimated 350 adults develop severe , but potentially reversible respiratory failure in the UK annually .
BACKGROUND	Current management uses intermittent positive pressure ventilation , but barotrauma , volutrauma and oxygen toxicity can prevent lung recovery .
BACKGROUND	An alternative treatment , extracorporeal membrane oxygenation , uses cardio-pulmonary bypass technology to temporarily provide gas exchange , allowing ventilator settings to be reduced .
BACKGROUND	While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure , there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults , although evidence from case series is promising .
METHODS	The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure ( CESAR ) is to assess whether , for patients with severe , but potentially reversible , respiratory failure , extracorporeal membrane oxygenation will increase the rate of survival without severe disability ( ` confined to bed ' and ` unable to wash or dress ' ) by six months post-randomisation , and be cost effective from the viewpoints of the NHS and society , compared to conventional ventilatory support .
METHODS	Following assent from a relative , adults ( 18-65 years ) with severe , but potentially reversible , respiratory failure ( Murray score > / = 3.0 or hypercapnea with pH < 7.2 ) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital , Leicester or continuing conventional care in a centre providing a high standard of conventional treatment .
METHODS	The central randomisation service will minimise by type of conventional treatment centre , age , duration of high pressure ventilation , hypoxia/hypercapnea , diagnosis and number of organs failed , to ensure balance in key prognostic variables .
METHODS	Extracorporeal membrane oxygenation will not be available for patients meeting entry criteria outside the trial .
METHODS	180 patients will be recruited to have 80 % power to be able to detect a one third reduction in the primary outcome from 65 % at 5 % level of statistical significance ( 2-sided test ) .
METHODS	Secondary outcomes include patient morbidity and health status at 6 months .
CONCLUSIONS	Analysis will be based on intention to treat .
CONCLUSIONS	A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments .

###12555300
BACKGROUND	The incidence and consequences of bacteraemia associated with diathermy and stapled haemorrhoidectomy have not been studied previously .
METHODS	Two hundred and five healthy patients randomized to stapled haemorrhoidectomy or diathermy haemorrhoidectomy had perioperative blood cultures taken .
METHODS	The clinical sequelae of bacteraemia and complications of surgery were assessed prospectively .
RESULTS	Six patients were excluded for protocol violations .
RESULTS	Eleven ( 11 per cent ) of 101 patients with stapled and five ( 5 per cent ) of 98 who had diathermy haemorrhoidectomy had positive blood cultures for organisms after haemorrhoidectomy , predominantly anaerobes commonly found within the bacterial flora of the anorectum ( P = 0.19 ) .
RESULTS	Transient postoperative pyrexia in several patients did not correlate with detected bacteraemia and settled spontaneously without treatment .
RESULTS	There were no serious complications from either operative technique , and no clinical consequences from proven bacteraemia .
CONCLUSIONS	Transient bacteraemia may complicate surgical haemorrhoidectomy but has no serious clinical consequences for healthy adults .

###19789440
OBJECTIVE	To investigate the impact of prophylactic continuous lateral rotation therapy on the prevalence of ventilator-associated pneumonia , duration of mechanical ventilation , length of stay , and mortality in critically ill medical patients .
METHODS	Prospective , randomized , clinical study .
METHODS	Three medical intensive care units of an university tertiary care hospital .
METHODS	Patients were randomized to continuous lateral rotation therapy or standard care if they were mechanically ventilated for < 48 hrs and free from pneumonia .
METHODS	Primary study end point was development of ventilator-associated pneumonia .
METHODS	Ventilator-associated pneumonia was defined as infiltrate on the chest radiograph plus newly developed purulent tracheal secretion plus increasing signs of inflammation .
METHODS	The diagnosis had to be confirmed microbiologically and required the growth of a pathogen > 10 ( 4 ) colony-forming units/mL in bronchoalveolar lavage .
METHODS	Radiologists were blinded to randomization whereas clinical outcome assessors were not .
METHODS	Rotation therapy was performed continuously in a specially designed bed over an arc of 90 degrees .
METHODS	Additional measures to prevent ventilator-associated pneumonia were equally standardized in both groups including semirecumbent position .
RESULTS	Ventilator-associated pneumonia frequency during the intensive care unit stay was 11 % in the rotation group and 23 % in the control group ( p = .048 ) , respectively .
RESULTS	Duration of ventilation ( 8 + / - 5 vs. 14 + / - 23 days , p = .02 ) and length of stay ( 25 + / - 22 days vs. 39 + / - 45 days , p = .01 ) were significantly shorter in the rotation group .
RESULTS	In a forward stepwise logistic regression model including the continuous lateral rotation therapy , gender , Lung Injury Score , and Simplified Acute Physiology Score II , continuous lateral rotation therapy just failed to reach statistical significance with respect to development of ventilator-associated pneumonia ( p = .08 ) .
RESULTS	Intolerance to continuous lateral rotation therapy during the weaning phase was observed in 29 patients ( 39 % ) .
RESULTS	Mortality was comparable in both groups .
CONCLUSIONS	Ventilator-associated pneumonia prevalence was significantly reduced by continuous lateral rotation therapy .
CONCLUSIONS	Continuous lateral rotation therapy led to shorter ventilation time and length of stay .
CONCLUSIONS	Continuous lateral rotation therapy should be considered in ventilated patients at risk for ventilator-associated pneumonia as a feasible method exerting additive effects to other preventive measures .

###24042190
OBJECTIVE	The requirements of biliary stents used in the palliation of malignant biliary obstruction are a long duration of patency and minimal adverse effects .
OBJECTIVE	Covered self-expandable metal stents ( SEMSs ) have been shown to prevent tumor ingrowth , which is the most frequent complication of uncovered SEMSs .
OBJECTIVE	However , because they are prone to migration , the superiority of covered SEMS has yet to be convincingly demonstrated .
OBJECTIVE	The aim of this study was to evaluate the superiority of covered over uncovered SEMSs in the palliation of distal biliary obstruction due to unresectable pancreatic carcinoma , using both stent types with relatively low axial force and uncovered flared ends to prevent their migration .
METHODS	From April 2009 to December 2010 , 120 patients who were admitted to 22 tertiary-care centers because of distal biliary obstruction from unresectable pancreatic carcinomas were enrolled in this prospective randomized multicenter study .
METHODS	Patients were randomly assigned to receive a covered or uncovered SEMS deployed at the site of the biliary stricture during endoscopic retrograde cholangiopancreatography .
METHODS	Stent patency time , patient survival time , patient survival time without stent dysfunction ( time to stent dysfunction or patient death ) , cause of stent dysfunction ( ingrowth , overgrowth , migration , or sludge formation ) , and serious adverse events were compared between covered and uncovered SEMS groups .
RESULTS	Patient survival time in the two groups did not significantly differ ( median : 285 and 223 days , respectively ; P = 0.68 ) .
RESULTS	Patient survival time without stent dysfunction was significantly longer in the covered than in the uncovered SEMS group ( median : 187 vs. 132 days ; P = 0.043 ) .
RESULTS	Stent patency was also significantly longer in the covered than in the uncovered SEMS group ( means.d. : 219.3159.1 vs. 166.9124.9 days ; P = 0.047 ) .
RESULTS	Reintervention for stent dysfunction was performed in 14 of 60 patients with covered SEMSs ( 23 % ) and in 22 of 60 patients with uncovered SEMSs ( 37 % ; P = 0.08 ) .
RESULTS	Stent dysfunction was caused by tumor ingrowth , tumor overgrowth , and sludge formation in 0 ( 0 % ) , 3 ( 5 % ) , and 11 ( 18 % ) patients in the covered SEMSs group , and in 15 ( 25 % ) , 2 ( 3 % ) , and 6 ( 10 % ) patients in the uncovered SEMSs group , respectively .
RESULTS	Stent migration was not observed in either group .
RESULTS	Rates of tumor overgrowth and sludge formation did not significantly differ between the two groups , whereas the rate of tumor ingrowth was significantly lower in the covered than in the uncovered SEMS group ( P < 0.01 ) .
RESULTS	Acute pancreatitis occurred in only one patient in the covered SEMS group .
RESULTS	Acute cholecystitis occurred in one patient in the covered SEMS group and in two patients in the uncovered SEMS group .
RESULTS	There was no significant difference between the two groups in the incidence of serious adverse events .
CONCLUSIONS	By preventing tumor ingrowth and migration , covered SEMSs with an anti-migration system had a longer duration of patency than uncovered SEMSs , which recommends their use in the palliative treatment of patients with biliary obstruction due to pancreatic carcinomas .

###20890699
OBJECTIVE	The apparent synovial hypertrophy in some cases of noninflammatory knee osteoarthritis suggests that total synovectomy may provide beneficial inflammatory and pain relief after total knee arthroplasty .
OBJECTIVE	The aim of the study was to compare the effect of synovectomy on the postoperative pain , bleeding and functional outcome after surgical treatment of knee osteoarthritis .
METHODS	A total of 50 patients with bilateral , non inflammatory , primary knee osteoarthritis were included in the study .
METHODS	Bilateral total knee replacement was performed at the same session .
METHODS	Total synovectomy and total knee arthroplasty ( study group ) were applied to a randomly selected side , and the total knee arthroplasty alone ( as control group ) was applied to the contralateral side of the same patient .
METHODS	The overall efficacy of both procedures was assessed postoperatively by determination of blood loss from the drain , pain and functional scores .
METHODS	The Visual Analogue Scale of pain and the Knee Society Knee Score were used to compare the two groups at 3rd , 6th and 12th months , postoperatively .
RESULTS	During the postoperative 48 h , the mean blood loss in the study group ( with synovectomy ) was significantly higher than the control group ( P = 0.005 ) .
RESULTS	However , in the postoperative follow-up time , there was no significant difference in pain relief and in the Knee Society Score between the two groups .
CONCLUSIONS	Performing synovectomy in patients with primary knee osteoarthritis does not seem to have any clinical advantage besides it might increase blood loss and recurrent hemarthrosis postoperatively .
CONCLUSIONS	Thus , during arthroplasty surgery , it should not be performed routinely .

###11693896
OBJECTIVE	Zoledronic acid , a new and more potent bisphosphonate , was compared with pamidronate , the current standard treatment for patients with osteolytic or mixed bone metastases/lesions .
METHODS	A total of 1,648 patients with either Durie-Salmon stage III multiple myeloma or advanced breast cancer and at least one bone lesion were randomly assigned to treatment with either 4 or 8 mg of zoledronic acid via 15-minute intravenous infusion or 90 mg of pamidronate via 2-hour intravenous infusion every 3 to 4 weeks for 12 months .
METHODS	The primary efficacy endpoint was the proportion of patients experiencing at least one skeletal-related event over 13 months .
RESULTS	The proportion of patients with at least one skeletal-related event was similar in all treatment groups .
RESULTS	Median time to the first skeletal-related eventwas approximately 1 year in each treatment group .
RESULTS	The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate , and zoledronic acid ( 4 mg ) significantly decreased the incidence and event rate for radiation therapy to bone , both overall and in breast cancer patients receiving hormonal therapy .
RESULTS	Pain scores decreased in all treatment groups in the presence of stable or decreased analgesic use .
RESULTS	Zoledronic acid ( 4 mg ) and pamidronate were equally well tolerated ; the most common adverse events were bone pain , nausea , fatigue , and fever and < 5 % of serious adverse events were related to the study drug .
RESULTS	The incidence of renal impairment among patients treated with 4 mg of zoledronic acid via 15-minute infusion was similar to that among patients treated with pamidronate .
CONCLUSIONS	Zoledronic acid ( 4 mg ) via 15-minute intravenous infusion was as effective and well tolerated as 90 mg of pamidronate in the treatment of osteolytic and mixed bone metastases/lesions in patients with advanced breast cancer or multiple myeloma .
CONCLUSIONS	( Can -

###20646829
OBJECTIVE	The use of ventriculo-peritoneal shunts having antisiphon device has been reported in adult patients , but there is a dearth of experience with such shunts in pediatric age group .
OBJECTIVE	This study is being undertaken to compare the effectiveness of these types of shunt for the treatment of congenital hydrocephalus .
METHODS	Forty patients with congenital hydrocephalus with or without neural tube were divided randomly into two groups ( A and B ) .
METHODS	Patients in antisiphon group were treated with shunts with differential valve including antisiphon device ( Vygon shunt ) while patients in non-antisiphon group were treated with differential valve shunts ( Chhabra shunt and Ceredrain ) .
METHODS	Mann-Whitney test , asymmetric t-test and Chi-square test were used to assess the correlation and the significance .
RESULTS	The mean age was 3.5 months and 3.4 months in antisiphon group and non-antisiphon group , respectively .
RESULTS	The M : F ratio was 2.3:1 in antisiphon group while it was 3:1 in non-antisiphon group .
RESULTS	The mean decrease in OFC was more in non-antisiphon group than antisiphon group during the follow up from 3 months to 6 months while mean decrease in MEI was more in non-antisiphon group from 0 month to 3 months than antisiphon group .
RESULTS	There were two cases of shunt overdrainage in non-antisiphon group .
RESULTS	The shunt blockage rate was 20 % in antisiphon group and 15 % in non-antisiphon group , respectively .
RESULTS	There was 20 % and 15 % shunt infection rate in antisiphon group and non-antisiphon group , respectively .
RESULTS	This study demonstrated overdrainage syndrome in two of the patients of differential valve shunts .
CONCLUSIONS	Though rare , complication associated with overdrainage is certainly a problem in children .
CONCLUSIONS	In our study , the patients who received shunts with antisiphon device do not show any overdrainage .

###12727580
OBJECTIVE	Genistein , a phytoestrogen found in soybeans , corrects endothelial dysfunction induced by oophorectomy in animals .
OBJECTIVE	Using a double-blind , controlled , randomized design , we evaluated its effects on endothelial function in women .
METHODS	We enrolled 79 healthy postmenopausal women ( mean [ + / - SD ] age , 56 + / - 4 years ) and randomly assigned them to receive continuous estrogen/progestin therapy ( n = 26 ; 17beta-estradiol [ 1 mg/d ] combined with norethisterone acetate [ 0.5 mg/d ] ) , genistein ( n = 27 ; 54 mg/d ) , or placebo ( n = 26 ) .
METHODS	Brachial artery flow-mediated , endothelium-dependent vasodilation and plasma levels of nitrites/nitrates ( a marker of nitric oxide metabolism ) and endothelin-1 were measured at baseline and after 1 year of therapy .
RESULTS	Treatment with genistein increased levels of nitrites/nitrates ( mean increase , 21 micromol/L ; 95 % confidence interval [ CI ] : 15 to 26 micromol/L ; P < 0.001 vs. placebo ) ; estrogen/progestin therapy caused similar changes ( P < 0.001 vs. placebo ) .
RESULTS	Plasma endothelin-1 levels decreased following 12 months of genistein ( mean decrease , 7 pg/mL ; 95 % CI : 3 to 10 pg/mL ; P < 0.001 vs. placebo ) and after 12 months of estrogen/progestin ( P < 0.001 vs. placebo ) .
RESULTS	When compared with placebo , brachial artery flow-mediated dilation was improved by genistein ( mean increase , 5.5 % ; 95 % CI : 3.9 % to 7.0 % ; P < 0.001 ) and by estrogen/progestin ( P < 0.001 ) .
RESULTS	There were no significant differences between estrogen and genistein for any of these parameters ( all P > 0.4 ) .
CONCLUSIONS	One year of genistein therapy improves endothelium function in postmenopausal women to a similar extent as does an estrogen/progestin regimen .

###11421840
BACKGROUND	Prevention of hypotension during spinal anaesthesia is commonly achieved using fluid preloading .
BACKGROUND	This may result in a substantial amount of excess free water retained in the body after spinal anaesthesia .
BACKGROUND	We aimed to evaluate the effects of 7.5 % hypertonic saline on extracellular water volume and haemodynamics when used for fluid preloading before spinal anaesthesia .
METHODS	This randomised double-blind study evaluated the effects of 75 mg/ml ( 7.5 % ) hypertonic saline ( HS ) on extracellular water volume and haematocrit in patients undergoing arthroscopy or other lower limb surgery under spinal anaesthesia .
METHODS	Amounts of 1.6 ml/kg of HS ( 20 patients ) or 13 ml/kg of 9 mg/ml normal saline ( 20 patients ) were administered for preloading before spinal anaesthesia with a 10 mg dose of 0.5 % hyperbaric bupivacaine .
METHODS	Etilefrine was administered in order to maintain mean arterial pressure ( MAP ) at > or = 80 % of its baseline value .
METHODS	Whole-body impedance cardiography-derived cardiac index ( CI ) and extracellular water ( ECW ) were measured .
RESULTS	There were no significant differences in demographic data or in the number of blocked segments .
RESULTS	ECW remained similar in both groups despite the much smaller amount of infused free water in the HS group .
RESULTS	There were no significant differences between the groups in CI values during the study .
RESULTS	The amount of etilefrine administered was similar in the treatment groups .
RESULTS	Dilution of haematocrit was also similar in both groups .
CONCLUSIONS	Hypertonic 75 mg/ml ( 7.5 % ) saline is an alternative for preloading before spinal anaesthesia in situations where excess free water administration is not desired .
CONCLUSIONS	It is effective in small doses of 1.6 ml/kg , which increase the extracellular water , plasma volume and cardiac output , and thus maintain haemodynamic stability during spinal anaesthesia .

###10480824
OBJECTIVE	To evaluate the effectiveness of a population based , multifaceted shared care intervention for late life depression in residential care .
METHODS	Randomised controlled trial , with control and intervention groups studied one after the other and blind follow up after 9.5 months .
METHODS	Population of residential facility in Sydney living in self care units and hostels .
METHODS	220 depressed residents aged > / = 65 without severe cognitive impairment .
METHODS	The shared care intervention included : ( a ) multidisciplinary consultation and collaboration , ( b ) training of general practitioners and carers in detection and management of depression , and ( c ) depression related health education and activity programmes for residents .
METHODS	The control group received routine care .
METHODS	Geriatric depression scale .
RESULTS	Intention to treat analysis was used .
RESULTS	There was significantly more movement to `` less depressed '' levels of depression at follow up in the intervention than control group ( Mantel-Haenszel stratification test , P = 0.0125 ) .
RESULTS	Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders , with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group ( 95 % confidence interval 0.76 to 2.97 , P = 0.0011 ) .
CONCLUSIONS	The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration , by enhancing the clinical skills of general practitioners and care staff , and by providing depression related health education and activity programmes for residents .

###25872502
BACKGROUND	Cardiac arrest causes ischaemic brain injury .
BACKGROUND	Arterial carbon dioxide tension ( PaCO2 ) is a major determinant of cerebral blood flow .
BACKGROUND	Thus , mild hypercapnia in the 24 h following cardiac arrest may increase cerebral blood flow and attenuate such injury .
BACKGROUND	We describe the Carbon Control and Cardiac Arrest ( CCC ) trial .
METHODS	The CCC trial is a pilot multicentre feasibility , safety and biological efficacy randomized controlled trial recruiting adult cardiac arrest patients admitted to the intensive care unit after return of spontaneous circulation .
METHODS	At admission , using concealed allocation , participants are randomized to 24 h of either normocapnia ( PaCO2 35 to 45 mmHg ) or mild hypercapnia ( PaCO2 50 to 55 mmHg ) .
METHODS	Key feasibility outcomes are recruitment rate and protocol compliance rate .
METHODS	The primary biological efficacy and biological safety measures are the between-groups difference in serum neuron-specific enolase and S100b protein levels at 24 h , 48 h and 72 h. Secondary outcome measure include adverse events , in-hospital mortality , and neurological assessment at 6 months .
CONCLUSIONS	The trial commenced in December 2012 and , when completed , will provide clinical evidence as to whether targeting mild hypercapnia for 24 h following intensive care unit admission for cardiac arrest patients is feasible and safe and whether it results in decreased concentrations of neurological injury biomarkers compared with normocapnia .
CONCLUSIONS	Trial results will also be used to determine whether a phase IIb study powered for survival at 90 days is feasible and justified .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000690853 .

###24192586
OBJECTIVE	Cognitive processing plays an important role in balance and gait and is a contributing factor to falls in older adults .
OBJECTIVE	This relationship may be explained by the fact that higher order cognitive functions such as executive functions are called upon while walking .
OBJECTIVE	The purpose of this study was to examine whether a cognitive training intervention leads to significant improvements on measures of balance and gait .
METHODS	This randomized trial tested whether cognitive training over 10 weeks improves balance and gait in older adults .
METHODS	Participants were randomly assigned to a computer-based cognitive training intervention or measurement-only control .
METHODS	Outcomes included Timed Up and Go ( TUG ) , gait speed , and gait speed with a cognitive distraction .
METHODS	Data were analyzed using analysis of covariance models with change scores .
RESULTS	Participants ' ( N = 51 ) average age was 82.7 for those randomized to intervention and 81.1 for those randomized to control .
RESULTS	After 10 weeks , intervention group participants performed significantly better than controls on the TUG .
RESULTS	When the cohort was limited to those categorized as slow walkers ( baseline 10-m walk 9 s ) , intervention participants performed significantly better than controls on TUG and distracted walking .
CONCLUSIONS	Cognitive training slows degradation of balance and improves gait while distracted , rendering it a promising approach to falls prevention .

###22398127
OBJECTIVE	To evaluate the efficacy of metformin for treatment of antipsychotic-induced weight gain .
METHODS	Seventy-two patients with first-episode schizophrenia who gained more than 7 % of their predrug weight were randomly assigned to receive 1000 mg/d of metformin or placebo in addition to their ongoing treatment for 12 weeks using a double-blind study design .
METHODS	The primary outcome was change in body weight .
METHODS	The secondary outcomes included changes in body mass index , fasting glucose and insulin , and insulin resistance index .
RESULTS	Of the 72 patients who were randomly assigned , 66 ( 91.6 % ) completed treatments .
RESULTS	The body weight , body mass index , fasting insulin and insulin resistance index decreased significantly in the metformin group , but increased in the placebo group during the 12-week follow-up period .
RESULTS	Significantly more patients in the metformin group lost their baseline weight by more than 7 % , which was the cutoff for clinically meaningful weight loss .
RESULTS	Metformin was tolerated well by majority patients .
CONCLUSIONS	Metformin was effective and safe in attenuating antipsychotic-induced weight gain and insulin resistance in first-episode schizophrenia patients .
CONCLUSIONS	Patients displayed good adherence to metformin .

###21378389
OBJECTIVE	Hyperglycaemia has been associated with increased platelet reactivity and impaired prognosis in patients with acute coronary syndrome ( ACS ) .
OBJECTIVE	Whether platelet reactivity can be reduced by lowering glucose in this setting is unknown .
OBJECTIVE	The aim of this study was to assess the functional impact of intensive glucose control with insulin on platelet reactivity in patients admitted with ACS and hyperglycaemia .
METHODS	This is a prospective , randomised trial evaluating the effects of either intensive glucose control ( target glucose 80-120 mg/dl ) or conventional control ( target glucose 180 mg/dl or less ) with insulin on platelet reactivity in patients with ACS and hyperglycaemia .
METHODS	The primary endpoint was platelet aggregation following stimuli with 20 M ADP at 24 h and at hospital discharge .
METHODS	Aggregation following collagen , epinephrine and thrombin receptor-activated peptide , as well as P2Y reactivity index and surface expression of glycoprotein IIb/IIIa and P-selectin were also measured .
RESULTS	Of the 115 patients who underwent random assignment , 59 were assigned to intensive and 56 to conventional glucose control .
RESULTS	Baseline platelet functions and inhospital management were similar in both groups .
RESULTS	Maximal aggregation after ADP stimulation at hospital discharge was lower in the intensive group ( 47.9 13.2 % vs 59.1 17.3 % ; p = 0.002 ) , whereas no differences were found at 24 h. Similarly all other parameters of platelet reactivity measured at hospital discharge were significantly reduced in the intensive glucose control group .
CONCLUSIONS	In this randomised trial , early intensive glucose control with insulin in patients with ACS presenting with hyperglycaemia was found to decrease platelet reactivity .
CONCLUSIONS	Clinical Trial Registration Number http://www.controlledtrials.com/ISRCTN35708451/ISRCTN35708451 .

###17437819
OBJECTIVE	Patients with adverse pathological features are at high risk for recurrence following radical prostatectomy .
OBJECTIVE	To improve outcomes in this population we performed a phase II study of adjuvant docetaxel in these high risk patients .
METHODS	Patients with nonmetastatic radical prostatectomy at greater than 50 % risk for recurrence by 3 years were eligible .
METHODS	Pathological findings were centrally reviewed and risk assessment was based on a validated multivariate Cox proportional hazards model .
METHODS	Treatment consisted of 6 cycles of 35 mg/m ( 2 ) docetaxel weekly given 4 to 12 weeks following surgery .
METHODS	Progression was defined as a prostate specific antigen of 0.4 ng/ml or greater , radiological/pathological evidence of recurrent disease or death from any cause .
METHODS	To screen for the potential benefit of adjuvant weekly docetaxel we used nomogram predicted progression-free survival as a historical control .
RESULTS	A total of 77 patients were registered between April 2002 and January 2004 .
RESULTS	Two patients had grade IV hyperglycemia and 20 had grade III toxicity .
RESULTS	At a median followup of 29.2 months ( range 1.6 to 39.2 ) 46 of 76 evaluable cases ( 60.5 % ) progressed .
RESULTS	Observed median progression-free survival was 15.7 months ( 95 % CI 12.8-25 .1 ) .
RESULTS	Predicted median progression-free survival in a matched population was 10 months .
RESULTS	Seven patients died , including 4 of prostate cancer , 1 with intra-abdominal bleeding during treatment and 2 of pneumonia and sudden cardiac death , respectively , following treatment .
CONCLUSIONS	Adjuvant docetaxel for prostate cancer is feasible with significant reversible but acceptable toxicity .
CONCLUSIONS	The actual median progression-free survival of 15.7 months was longer than the nomogram predicted rate for this patient population .
CONCLUSIONS	Adjuvant docetaxel treatment should be further evaluated in phase III trials in patients with high risk prostate cancer .

###11394734
BACKGROUND	The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined .
BACKGROUND	Based on a search of MEDLINE , no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate ( RBC ) - based dual therapy regimen , both containing clarithromycin .
OBJECTIVE	This study was undertaken to compare the efficacy of lansoprazole ( LAN ) - based triple therapy with that of RBC-based dual therapy in H pylori-infected patients with duodenal ulcer .
METHODS	Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID , clarithromycin 500 mg BID , and tinidazole 500 mg BID , followed by 3 weeks of LAN 30 mg BID , or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID , followed by 2 weeks of RBC 400 mg BID .
METHODS	Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination > or = 4 weeks after the end of treatment .
METHODS	Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months .
METHODS	A per-protocol ( PP ) analysis was conducted for each efficacy end point .
METHODS	Also conducted were an intent-to-treat ( ITT ) analysis in which patients with missing data were considered failures , and an observed analysis ( OBS ) , which included patients with an evaluable result after treatment , regardless of compliance .
RESULTS	One hundred eighty-five patients ( 126 men , 59 women ; age range , 18-76 years ; mean age , 43 years ) were enrolled and randomized to treatment .
RESULTS	In the LAN and RBC groups , respectively , H. pylori eradication rates were 92.6 % , 93.1 % , and 72.8 % versus 78.6 % , 77.9 % , and 64.5 % in the PP ( P = 0.02 ) , OBS ( P = 0.01 ) , and ITT analyses .
RESULTS	The corresponding duodenal ulcer healing rates were 98.6 % , 98.7 % , and 83.7 % versus 90.8 % , 91.5 % , and 81.7 % ; these differences were not statistically significant .
RESULTS	Side effects were mild , occurring in 20.7 % of LAN patients and 17.2 % of RBC patients .
RESULTS	Ulcer recurred in 2 RBC patients .
RESULTS	No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms .
CONCLUSIONS	Based on the results of the PP and OBS analyses , LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H. pylori in patients with duodenal ulcer .

###11803077
BACKGROUND	Increasing travel stresses the requirement for rapid protection against infections such as hepatitis A and B.
METHODS	This randomised , multicentre study investigated an accelerated vaccination schedule using a combined hepatitis A and B vaccine ( Twinrix , Smithkline Beecham Biologicals ) compared with simultaneous administration of the two corresponding monovalent vaccines .
METHODS	The combined vaccine was administered on days 0 , 7 and 21 , whereas the comparison group received hepatitis A vaccine on day 0 and hepatitis B vaccine on days 0 , 7 and 21 .
METHODS	All subjects received booster vaccination at month 12 .
RESULTS	At month 1 , 100 % of subjects in the combined group and 99 % of the controls were seropositive for anti-HAV antibodies .
RESULTS	The corresponding seroprotection rates for anti-HBs antibodies were 82.0 and 83.9 % , respectively .
RESULTS	Examination of the 95 % confidence intervals ( CIs ) for the treatment differences showed the two vaccines to be equivalent in terms of immunogenicity 1 week after the initial vaccination course .
RESULTS	Just prior to the booster , the seropositivity rate for anti-HAV was 96.2 % in the combined group and 95 % in the control group .
RESULTS	For anti-HBs , this was 94 and 91.6 % , respectively .
RESULTS	All subjects were seropositive for anti-HAV and seroprotected against hepatitis B at month 13 .
RESULTS	The anti-HAV GMCs were 9571mIU/ml with the combined vaccine and 5206mIU/ml in control subjects .
RESULTS	The anti-HBs titre was 26002 and 29,196 mIU/ml , respectively .
RESULTS	Both groups had a similar reactogenicity profile .
CONCLUSIONS	The accelerated schedule of the combined vaccine provides a good immune response against hepatitis A and B antigens and is suitable for last minute immunisation .

###14712970
OBJECTIVE	To investigate the effect of a ginger extract ( EV.EXT35 ) on the symptoms of morning sickness .
METHODS	Double-blind randomised placebo-controlled trial .
METHODS	A tertiary metropolitan teaching hospital , March 1999-November 1999 .
METHODS	The participants included 120 women less than 20 weeks pregnant , who had experienced morning sickness daily for at least a week and had had no relief of symptoms through dietary changes .
METHODS	Random allocation of 125 mg ginger extract ( EV.EXT35 ; equivalent to 1.5 g of dried ginger ) or placebo given four times per day for 4 days .
METHODS	Nausea , vomiting and retching as measured by the Rhodes Index of Nausea , Vomiting and Retching .
RESULTS	The nausea experience score was significantly less for the ginger extract group relative to the placebo group after the first day of treatment and this difference was present for each treatment day .
RESULTS	Retching was also reduced by the ginger extract although to a lesser extent .
RESULTS	No significant effect was observed on vomiting .
RESULTS	Follow-up of the pregnancies revealed normal ranges of birthweight , gestational age , Apgar scores and frequencies of congenital abnormalities when the study group infants were compared to the general population of infants born at the Royal Hospital for Women for the year 1999-2000 .
CONCLUSIONS	Ginger can be considered as a useful treatment option for women suffering from morning sickness .

###25315664
OBJECTIVE	To determine the prognostic value of outer retinal tubulation ( ORT ) in the enlargement amount of geographic atrophy ( GA ) in eyes with age-related macular degeneration ( AMD ) .
METHODS	Cohort study .
METHODS	One hundred eight fellow untreated eyes of 143 patients with GA resulting from AMD enrolled in the MAHALO study ( clinicaltrials.gov identifier , NCT01229215 ) who completely satisfied the study term and had gradable spectral-domain optical coherence tomography ( OCT ) images obtained at both baseline and month 18 visits .
METHODS	The MAHALO study enrolled 143 subjects into a phase 1b/2 multicenter , randomized , single-masked , sham-injection controlled clinical trial of the safety , tolerability , and evidence of activity of lampalizumab in patients with GA associated with AMD .
METHODS	Spectral-domain optical coherence tomography images were obtained at multiple time points in both eyes , although only the baseline and month 18 data of the fellow ( nonstudy ) eyes were considered in this exploratory analysis .
METHODS	The Cirrus HD-OCT review software was used for automatic segmentation and measurement of GA areas , with manual correction of segmentation errors by certified OCT graders .
METHODS	Baseline OCT images also were assessed for the presence of ORT .
METHODS	The enlargement amount of GA in eyes with ORT was compared with that of eyes without ORT .
METHODS	Comparison of the enlargement amount of GA in eyes with and without ORT .
RESULTS	Twenty-four of these 108 eyes demonstrated evidence of ORT .
RESULTS	The amount of enlargement of GA in eyes with ORT was significantly slower than that of eyes without ORT ( 1.850.78 vs. 2.671.61 ; P = 0.001 ) .
RESULTS	This difference remained significant when considering subgroups with unifocal or multifocal GA lesions , because eyes with ORT in both subgroups had a slower enlargement amount of GA than eyes without ORT ( 2.911.70 vs. 2.080.88 [ P = 0.01 ] , in eyes with multifocal GA lesions ; and 2.241.40 vs. 1.630.57 [ P = 0.02 ] , in eyes with unifocal GA lesions ) .
CONCLUSIONS	In eyes with ORT , GA lesions seem to enlarge at a significantly slower rate than those of eyes without ORT .
CONCLUSIONS	The presence of ORT may need to be accounted for in longitudinal studies of GA. .

###19891806
BACKGROUND	This study examined therapist-patient interactions during clinical management with antidepressant medication and pill-placebo .
METHODS	The sample consisted of 80 patients on active medication and 40 patients in a pill-placebo condition from a randomized controlled trial for moderate to severe depression .
METHODS	Pharmacotherapist-patient interactions were characterized using observer ratings of the therapeutic alliance , pharmacotherapist-offered facilitative conditions , pharmacotherapist adherence to clinical management treatment guidelines and pharmacotherapist competence .
METHODS	Patients , therapists and raters were blind to treatment condition and outcome .
RESULTS	Provision of greater non-specific support ( facilitative conditions ) in early sessions predicted less subsequent improvement in depressive symptoms for patients receiving pill-placebo but not those receiving active medications , for which none of the process ratings predicted subsequent change .
RESULTS	Early symptom change predicted later alliance and adherence in both conditions and therapist competence in the active condition .
CONCLUSIONS	Higher levels of support in early sessions predict poorer subsequent response among placebo patients .
CONCLUSIONS	It remains unclear whether patients who are likely to be refractory elicit greater non-specific support or whether the provision of such support has a deleterious effect in unmedicated patients .
CONCLUSIONS	Differences in treatment process variables between conditions late in treatment are likely to be largely a consequence of symptom relief produced by active medications .

###11182012
BACKGROUND	A systematic literature review was conducted to assess the effect of treating reflux oesophagitis on asthma outcomes .
METHODS	Randomised controlled trials of reflux oesophagitis treatment in adults or children that reported asthma health outcomes were included and assessed in accordance with the standard Cochrane systematic review process .
METHODS	Patients were typically adults with asthma and concurrent symptomatic gastro-oesophageal reflux who received interventions that included pharmacological therapy , conservative management , and surgery .
METHODS	The following outcome measures were assessed : lung function , peak expiratory flow , asthma symptoms , asthma medications , and nocturnal asthma .
RESULTS	From 22 potentially relevant published and unpublished randomised controlled trials , 12 were included .
RESULTS	Treatment duration ranged from 1 week to 6 months .
RESULTS	Eight trials reported that treatment improved at least one asthma outcome , but these outcomes differed between trials .
RESULTS	Overall , treatment of reflux oesophagitis did not consistently improve forced expiratory volume in one second ( FEV ( 1 ) ) , peak expiratory flow rate , asthma symptoms , nocturnal asthma symptoms , or use of asthma medications in asthmatic subjects .
RESULTS	Significant improvement in wheeze was reported in two studies .
CONCLUSIONS	The published literature does not consistently support treatment of reflux oesophagitis as a means of controlling asthma .
CONCLUSIONS	Further large randomised controlled trials in subjects with a demonstrated temporal relationship between gastro-oesophageal reflux and asthma are needed .
CONCLUSIONS	These trials should be conducted over at least 6 months to allow adequate time to observe a treatment effect .

###15860476
BACKGROUND	Few studies evaluate whether short-term intervention effects are maintained over time for families caring for persons with dementia .
BACKGROUND	This article examines whether treatment effects found at 6 months following active treatment were sustained at 12 months for 127 family caregivers who participated in an occupational therapy intervention tested as part of the National Institutes of Health Resources for Enhancing Alzheimer 's Caregiver Health ( REACH ) initiative .
METHODS	A randomized two-group design was implemented with three assessment points : baseline , 6 months , and 12 months .
METHODS	Caregivers were randomly assigned to a usual care control group or intervention that consisted of six occupational therapy sessions to help families modify the environment to support daily function of the person with dementia and reduce caregiver burden .
METHODS	Following 6-month active treatment , a maintenance phase consisted of one home and three brief telephone sessions to reinforce strategy use and obtain closure .
METHODS	Non-inferiority statistical analysis was used to evaluate whether intervention caregivers maintained treatment benefits from 6 to 12 months in comparison to controls .
RESULTS	For the sample of 127 at 6 months , caregivers in intervention reported improved skills ( p = .028 ) , less need for help providing assistance ( p = .043 ) , and fewer behavioral occurrences ( p = .019 ) compared to caregivers in control .
RESULTS	At 12 months , caregiver affect improved ( p = .033 ) , and there was a trend for maintenance of skills and reduced behavioral occurrences , but not for other outcome measures .
CONCLUSIONS	An in-home skills training program helps sustain caregiver affect for those enrolled for more than 1 year .
CONCLUSIONS	More frequent professional contact and ongoing skills training may be necessary to maintain other clinically important outcomes such as reduced upset with behaviors .

###19092677
BACKGROUND	Focal electrically administered therapy is a new method of transcranial electrical stimulation capable of focal modulation of cerebral activity .
BACKGROUND	Other than invasive studies in animals and examination of motor output in humans , there are limited possibilities for establishing basic principles about how variation in stimulus parameters impact on patterns of intracortical stimulation .
BACKGROUND	This study used a simpler paradigm and evaluated the effects of different stimulation parameters on subjective perception of the quality and location of scalp pain .
METHODS	In 2 studies , 19 subjects were randomly stimulated over the left forehead , varying the anode-cathode arrangement , the intensity of stimulation , the electrode size and placement , and whether the current flow was unidirectional or bidirectional .
METHODS	Subjects rated the location of the sensation and its quality .
RESULTS	The perceived center of stimulation moved toward the cathode , regardless of placement .
RESULTS	This shift in subjective sensation was more prominent when the electricity was unidirectional .
RESULTS	In addition , more intense stimulation , as well as stimulation with a smaller electrode , caused greater perceived pain .
RESULTS	Unidirectional stimulation was rated more painful when traveling from a large anode to a small cathode and less painful when traveling from a small anode to a large cathode .
RESULTS	Finally , participants were more likely to perceive the electrical stimulation as moving toward a specific direction when the intensity was high than when it was low .
CONCLUSIONS	The intensity and location of sensations can be manipulated by varying the intensity , current direction , or geometry of electrodes .

###17010864
OBJECTIVE	To evaluate ultrasound ( US ) energy and endothelial cell loss in cataract surgery using the stop-and-chop and nuclear preslice techniques .
METHODS	Vision Institute , Federal University of So Paulo , So Paulo , Brazil .
METHODS	This prospective clinical trial comprised 43 patients ( 50 eyes ) with senile nuclear cataract who were randomly assigned to 1 of 2 groups : stop-and-chop ( n = 26 ) or nuclear preslice ( n = 24 ) .
METHODS	The groups were divided according to nuclear density ( NO ( 3 ) NC ( 3 ) and NO ( 4 ) NC ( 4 ) ) using the Lens Opacity Classification System III .
METHODS	A full ophthalmic examination including biometry , specular microscopy , and pachymetry was performed preoperatively and postoperatively .
METHODS	The following parameters were evaluated : age , anterior chamber depth , lens thickness , axial length , phaco time and power , effective phaco time ( EPT ) , infusion volume , ocular inflammation , endothelial cell loss , and best corrected visual acuity ( BCVA ) .
RESULTS	Phacoemulsification time , power , and EPT were significantly higher in the stop-and-chop group .
RESULTS	Infusion volumes did not vary significantly between the groups .
RESULTS	A significant decrease in endothelial cell density occurred postoperatively and was similar with both techniques ( stop-and-chop , 8.70 % ; nuclear preslice , 8.72 % ) .
RESULTS	The BCVA improved significantly in both groups .
RESULTS	No significant correlations were found between endothelial cell loss and either technique .
CONCLUSIONS	Ultrasound energy consumption was lower with the nuclear preslice technique .
CONCLUSIONS	Both techniques had similar results including endothelial cell loss .

###16862038
BACKGROUND	Personal care services ( PCS ) are intended to enable beneficiaries with physical or cognitive impairments to live safely at home rather than in nursing facilities .
BACKGROUND	The quality and flexibility of these services , typically provided by home care agencies , may not be sufficient to allow some beneficiaries to continue living at home .
OBJECTIVE	We sought to test whether consumer direction of PCS under Arkansas 's Cash and Counseling demonstration reduces nursing facility use and expenditures , compared with traditional Medicaid PCS , and how it affects total Medicaid cost .
METHODS	Interested adult Medicaid beneficiaries in Arkansas who were eligible to receive Medicaid PCS were randomly assigned ( 1 ) to have the option to receive an allowance instead of PCS ( the treatment group ) or ( 2 ) to receive traditional PCS through an agency ( the control group ) .
METHODS	Between December 1998 and April 2001 , 2008 beneficiaries enrolled .
METHODS	: Nursing facility use and costs , PCS costs , and total Medicaid costs ( according to Medicaid claims data ) .
RESULTS	Nursing facility use was 18 % lower for the treatment group than for the control group during the 3-year follow-up period .
RESULTS	Among those who had received PCS before the demonstration , nursing facility savings , together with savings in other long-term care costs , fully offset the higher PCS costs .
RESULTS	These savings did not offset the higher PCS costs of new PCS applicants , since the increase in the proportion receiving paid care was so large for this subgroup .
CONCLUSIONS	Consumer-directed PCS in Arkansas reduces nursing facility use and costs more effectively than providing services in the traditional manner .
CONCLUSIONS	This favorable reduction in nursing facility costs was much more pronounced in Arkansas than in the other 2 states ( New Jersey and Florida ) where the Cash and Counseling demonstration was carried out .

###20642485
OBJECTIVE	To compare the efficacy of oxygen-ozone therapy and the combined use of oxygen-ozone therapy with percutaneous intradiscal radiofrequency thermocoagulation ( PIRFT ) for the treatment of contained lumbar disc herniation .
METHODS	Ninety-one adult patients with low back pain secondary to contained lumbar disc herniation were randomly assigned into two groups .
METHODS	Ozone group received intradiscal oxygen-ozone therapy ( 4 to 7 mL of oxygen ozone mixture ) ; ozone-PIRFT group received a combination of oxygen-ozone therapy with PIRFT ( radiofrequency lesioning at 80C for 360 s ) .
METHODS	Primary outcome measures included a visual analog scale ( VAS ) for pain and the Oswestry disability index ( ODI ) .
METHODS	Secondary outcome measures included pain relief , reduction of analgesic consumption , and patient 's satisfaction .
METHODS	Clinical assessment of these outcome measures was performed at 2 weeks , 1 month , 3 months , 6 months , and 1 year after the procedure .
RESULTS	VAS scores and ODI were significantly decreased by both ozone and ozone-PIRFT when compared with the baseline values at all points of follow-up ; however , ozone-PIRFT produced a significant reduction in the VAS scores and ODI when compared to ozone at 2 weeks , 1 month , 3 months , 6 months , and 1 year follow-up .
RESULTS	Ozone-PIRFT also resulted in a significant change in all secondary measures at all points of follow-up , as compared with the ozone group .
CONCLUSIONS	Ozone-PIRFT is more efficacious than ozone alone in reducing pain scores , analgesic consumption , improving functional outcome , and satisfaction of patients with contained lumbar disc herniation .

###24576912
BACKGROUND	Prehospital identification of acute stroke increases the possibility of early treatment and good outcome .
BACKGROUND	To increase identification of stroke , the Face Arm Speech Time ( FAST ) test was introduced in the Emergency Medical Communication Center ( EMCC ) .
BACKGROUND	This substudy aims to evaluate the implementation of the FAST test in the EMCC and the ambulance service .
METHODS	The study was conducted in the region of Stockholm , Sweden during 6 months .
METHODS	The study population consisted of all calls to the EMCC concerning patients presenting at least one FAST symptom or a history/finding making the EMCC or ambulance personnel to suspect stroke within 6 h. Positive FAST was compared to diagnosis at discharge .
METHODS	Positive predictive values ( PPV ) for a stroke diagnosis at discharge were calculated .
RESULTS	In all , 900 patients with a median age of 71 years were enrolled , 667 ( 74 % ) by the EMCC and 233 ( 26 % ) by the ambulances .
RESULTS	At discharge , 472 patients ( 52 % ) were diagnosed with stroke/transient ischemic attack ( TIA ) , 337 identified by the EMCC ( 71 % ) and 135 ( 29 % ) by the ambulances .
RESULTS	The PPV for a discharge diagnosis of stroke/TIA was 51 % ( CI 47-54 % ) in EMCC-enrolled and 58 % ( CI 52-64 % ) in ambulance-enrolled patients .
RESULTS	With a positive FAST the PPV of a correct stroke/TIA diagnosis increased to 56 % ( CI 52-61 % ) and 73 % ( CI 66-80 % ) in EMCC - and ambulance-enrolled patients , respectively .
RESULTS	Positive FAST from EMCC was also found in 44 % of patients with a nonstroke diagnosis at discharge .
RESULTS	A stroke/TIA diagnosis at discharge but negative FAST was found in 58 and 27 patients enrolled by the EMCC and ambulances , respectively .
CONCLUSIONS	The PPV of FAST is higher when used on the scene by ambulance than by EMCC .
CONCLUSIONS	FAST may be a useful prehospital tool to identify stroke/TIA but has limitations as the test can be negative in true strokes , can be positive in nonstrokes , and FAST symptoms may be present but not identified in the emergency call .
CONCLUSIONS	For the prehospital care situation better identification tools are needed .

###10563031
OBJECTIVE	To assess the acute-on-chronic effects of methadone on drug craving , mood and cognitive and psychomotor functioning in patients on long-term methadone substitution treatment .
METHODS	A double-blind , cross-over design was used to compare the effects of a 33 % increase in patient 's daily dosage of methadone with a matched placebo linctus .
METHODS	Eighteen patients completed the study ; all were assessed pre - and post-drug on two separate testing days .
RESULTS	Methadone significantly increased both positive craving ( expected positive effects ) and negative craving ( expected relief of withdrawal discomfort ) for heroin .
RESULTS	Patients were unable to distinguish between methadone and placebo treatments .
RESULTS	No differences between treatments emerged in cognitive or psychomotor effects .
RESULTS	In terms of mood , patients were more alert and more contented following placebo than following methadone .
CONCLUSIONS	Additional methadone may `` prime '' cravings for heroin in methadone substitution patients .

###10608589
BACKGROUND	Recently oral glucose loading and a thallium-glucose insulin infusion have been used to augment myocardial uptake of thallium-201 ( TI-201 ) .
BACKGROUND	Acipimox is a nicotinic-acid derivative that reduces serum free fatty acid ( FFA ) levels and enhances myocardial glucose uptake .
BACKGROUND	This study was performed to assess the effects of acipimox on TI-201 redistribution .
METHODS	Fourteen patients with coronary artery disease underwent 2 successive TI-201 perfusion studies .
METHODS	Stress was performed by adenosine coupled with ergometer exercise .
METHODS	Patients received either 500 mg of acipimox or placebo immediately after stress , and images were acquired .
METHODS	Redistribution imaging was carried out after 4 hours .
METHODS	Patients returned after 7 to 14 days for a repeat stress protocol , receiving the alternate test article .
METHODS	Both studies were carried out under identical conditions with identical medication with the patient in the fasting state .
METHODS	Image analysis was conducted quantitatively with polar plots and by using segmental uptake as a percentage of maximal counts with a 9-segment model .
RESULTS	There were no significant differences between the acipimox and placebo arms of the study of hemodynamic parameters .
RESULTS	On polar plot analysis , there were no differences between acipimox and placebo for mean values of stress defect extent ( 97 + / - 16.1 vs 96.5 + / - 18.8 pixels ) , defect severity ( 532.2 + / - 120 vs 537 + / - 133.9 standard deviations [ SDs ] ) , for defect reversibility ( 61.7 + / - 18 vs 55.4 + / - 15.3 SDs ) , and percentage reversibility ( 21.2 % + / - 5.5 % vs 19.2 % + / - 5.8 % ) , respectively .
RESULTS	Similarly , on segmental uptake analysis there was no significant difference between the acipimox and placebo arms with regard to the proportion of segments classified as normal , fixed defect , reversible defect , or reverse redistribution .
CONCLUSIONS	Although acipimox has been shown to augment myocardial glucose uptake and myocardial glucose uptake has been shown to improve cellular uptake of TI-201 , in the fasting state acipimox does not enhance the redistribution after stress .
CONCLUSIONS	This may be because serum insulin levels are not increased by acipimox , and insulin is instrumental in enhancing the joint transport of glucose and TI-201 into myocytes .

###25125457
BACKGROUND	In patients with Alzheimer 's disease ( AD ) , the relationship between cognitive and functional progression is not fully understood ; however , functional decline has been postulated to follow cognitive decline .
OBJECTIVE	To assess the relationship between cognitive and functional treatment effects in mild AD dementia patients .
METHODS	Data of patients with mild AD were pooled from two multicenter , double-blind , Phase 3 studies .
METHODS	Patients were randomized to infusions of 400-mg solanezumab ( n = 654 ) , or placebo ( n = 660 ) every 4 weeks for 18 months .
METHODS	Cognitive and functional outcome measures were assessed using the AD Assessment Scale-Cognitive subscale ( ADAS-Cog ) and the AD Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , respectively .
METHODS	Analyses included comparisons among normalized scales , correlations between outcome measures , and path analyses to model the relationship of treatment effect on cognition and function .
RESULTS	Normalized ADAS-Cog and ADCS-ADL scales showed cognitive impairment was more evident than functional impairment in mild AD .
RESULTS	The correlation between cognition and function increased over time .
RESULTS	Path analyses demonstrated that 87 % of the treatment effect on function was driven by the treatment effect on cognition , with the remaining 13 % due to direct treatment effect .
CONCLUSIONS	Findings from this study are consistent with the hypothesis that functional impairment is primarily driven by and follows cognitive decline in mild AD dementia .
CONCLUSIONS	The cognitive treatment effect appeared to explain the majority of the functional treatment effect .
CONCLUSIONS	It is possible that a cognitive treatment effect may be considered as a leading indicator for functional outcomes in an 18-month clinical trial for milder stages of AD .

###15128963
OBJECTIVE	The authors conducted a cost analysis for multisystemic therapy , an evidence-based treatment that is used as an intensive community-based alternative to the hospitalization of youths presenting with psychiatric emergencies .
METHODS	Data from a randomized clinical trial that compared multisystemic therapy with usual inpatient services followed by community aftercare were used to compare Medicaid costs and clinical outcomes during a four-month period postreferral and a 12-month follow-up period .
METHODS	Data were from 115 families receiving Medicaid ( out of 156 families in the clinical trial ) .
RESULTS	During the four months postreferral , multisystemic therapy was associated with an average net savings per youth treated of $ 1,617 compared with usual services .
RESULTS	Costs during the 12-month follow-up period were similar between treatments .
RESULTS	Multisystemic therapy demonstrated better short-term cost-effectiveness for each of the clinical outcomes ( externalizing behavior , internalizing behavior , and global severity of symptoms ) than did usual inpatient care and community aftercare .
RESULTS	The two treatments demonstrated equivalent long-term cost-effectiveness .
CONCLUSIONS	Among youths presenting with psychiatric emergencies , multisystemic therapy was associated with better outcomes at a lower cost during the initial postreferral period and with equivalent costs and outcomes during the 12-month follow-up period .

###10859081
OBJECTIVE	The purpose of this study was to evaluate the effectiveness of ketorolac combined with local anesthetics for anorectal surgery .
METHODS	From June 1998 through March 1999 , 123 outpatients undergoing anorectal surgery were entered into a prospective , randomized , double-blinded study involving three treatment groups .
METHODS	All patients received intravenous sedation consisting of fentanyl and a propofol infusion , with a local anesthesia mixture of lidocaine , bupivacaine , and bicarbonate .
METHODS	Group A ( 41 patients ) received placebo ( saline ) injections .
METHODS	Group B ( 41 patients ) received 60 mg of intravenous ketorolac at the onset of the procedure , and Group C ( 41 patients ) received 60 mg of ketorolac mixed with the local anesthetic .
METHODS	Data were analyzed using analysis of variance and chi-squared tests .
RESULTS	All groups had similar demographic characteristics and operative procedures .
RESULTS	Twenty-nine of the 123 patients were human immunodeficiency virus-positive .
RESULTS	There was no difference in operative or anesthesia time .
RESULTS	Anesthesia and fluids given were similar in across groups .
RESULTS	A significantly higher percentage of Group A patients had pain ( 34 percent ) and required additional oral analgesia ( 20 percent ) in the Day Surgery Unit .
RESULTS	Only 5 percent of Group B and Group C patients complained of pain , with oral analgesics given to 2 percent of Group B and none in Group C. Voiding difficulties were more common in Group A patients , one patient requiring catheterization .
CONCLUSIONS	The addition of ketorolac ( 60 mg ) , either intravenous or injected with local anesthetics , reduces voiding problems and significantly decreases postoperative analgesic requirements in outpatients undergoing anorectal surgery .

###19916263
BACKGROUND	Pulsed dye lasers ( PDL ) are one of the first , and popular , nonablative lasers for the treatment of rhytids and superficial pigmented lesions .
BACKGROUND	Recent addition of a compression handpiece ( CHP ) allows treatments with minimal adverse effects .
OBJECTIVE	The purpose of this study was to investigate the efficacy and safety of new parameters of 595 nm PDL in the treatment of lentigines and wrinkles in the darker skin phototypes .
METHODS	Ten female subjects with photodamaged skin were enrolled in this study .
METHODS	One side of the face received three monthly treatments with one pass of PDL with the fluence of 6 J/cm2 , 6 msec pulse duration followed by a second pass when lentigines were individually treated with CHP 6 J/cm2 , 6 msec with CHP .
METHODS	The untreated side served as control .
METHODS	Digital photography was used for global evaluation while the numbers of lentigines and wrinkles were analyzed by VISIA .
RESULTS	All 10 subjects , aged 39-55 years , completed the study .
RESULTS	The mean changes in numbers of lentigines at the twelfth week on the treated side was -6.1 ( decrease ) , while that of the controlled side was +2.8 ( increase ) ( P = 0.075 , paired t test ) .
RESULTS	There was also a statistically significant difference in the degree of improvement of lentigines by global assessment ( P = 0.008 , Wilcoxon signed rank test ) .
RESULTS	No statistically significant difference in the degree of improvement of wrinkles analyzed by VISIA ( P = 0.490 ) and global assessment ( P = 0.157 , Wilcoxon signed rank test ) was observed .
RESULTS	Hyperpigmentation was seen in two subjects .
CONCLUSIONS	The parameters of 595 nm PDL used in this study are effective and safe in the treatment of facial lentigines .
CONCLUSIONS	There was no significant improvement in wrinkles in this study .
CONCLUSIONS	A study limitation may be the relatively small sample size .

###12427067
OBJECTIVE	To investigate the consistency of visual acuity ( VA ) scores measured at 2 different distances in patients with or at risk for choroidal neovascularization .
METHODS	Best-corrected VA scores measured at 2 distances for the same eyes at the same examinations were collected from 4 sets of randomized clinical trials among patients with or at risk of choroidal neovascularization .
METHODS	Within each trial , the pairs of VA scores were compared and their relationship was explored .
RESULTS	After adjustment for test distance , VA scores obtained at the closer distance were found to be systematically lower than those obtained at the farther distance in all data sets .
RESULTS	In the Submacular Surgery Trials pilot study , the average discrepancy between 2 - and 0.5-m VA scores was 7.5 letters .
RESULTS	In an ancillary study of the Macular Photocoagulation Study , the discrepancy between 10-ft and 5-ft VA scores was 3.1 letters .
RESULTS	In the Laser to Drusen Trial pilot study , the discrepancy between 3.2 - and 1-m VA scores was 7.3 letters .
RESULTS	In the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy Study , in which the VA scores at the closer test distance were censored , the estimated discrepancy between 2 - and 1-m VA scores was 8.2 letters .
RESULTS	Reduction in visual angle at closer test distance did not explain the discrepancy completely .
RESULTS	Features of the macular lesion , poor accommodation of the elderly population with age-related macular degeneration , or the test charts did not account for the discrepancies .
CONCLUSIONS	The VA scores at distances less than 2 m were lower than expected in all 4 studies .
CONCLUSIONS	The observed discrepancy was consistent with findings from a study among healthy young subjects , suggesting that the phenomenon is real and common .

###25823177
OBJECTIVE	To compare the use of intralesional triamcinolone acetonide and its combination with 5 flourouracil in the treatment of keloid and hypertrophic scars in terms of reduction in initial height of the scar .
METHODS	The randomised controlled trial was conducted at the Department of Plastic Surgery , King Edward Medical University , Lahore , from March 2011 to December 2012 .
METHODS	It comprised patients of both genders having keloids or hypertrophic scars ( 1 cm to 5 cm in size ) having no history of treatment for the scars in preceding 6 months .
METHODS	Those who were pregnant , planning pregnancy or lactating were excluded .
METHODS	The subjects were divided into two groups : Group A received intralesional triamcinolone acetonide alone ; and Group B received triamcinolone acetonide + 5 flourouracil .
METHODS	Eight injections were given at weekly interval .
METHODS	Scars were assessed 4 weeks after the completion of treatment on a five-point scale .
METHODS	SPSS 16 was used for statistical analysis .
RESULTS	The 150 subjects in the study were divided into two equal groups of 75 ( 50 % ) each .
RESULTS	Good to excellent results were seen in 51 ( 68 % ) cases in Group A compared to 63 ( 84 % ) in Group B. Frequency of complications was 18 ( 24 % ) and 6 ( 8 % ) in Group A and Group B respectively .
CONCLUSIONS	Combination of triamcinolone acetonide and 5 flourouracil is superior to triamcinolone acetonide therapy in the treatment of keloids and hypertrophic scars .

###24099970
BACKGROUND	Healthcare professionals are crucial in access to treatment for patients with substance use disorders .
BACKGROUND	However , healthcare professionals often have negative attitudes towards this patient group .
BACKGROUND	Healthcare professionals ' regard for working with patients with substance use disorders was examined and three sectors in which professionals are working were compared .
METHODS	General practitioners ( GPs ; N = 180 ) , healthcare professionals of general psychiatry ( N = 89 ) and specialists in addiction services ( N = 78 ) filled out a questionnaire in which regard for working with patients with substance use disorders was assessed .
METHODS	ANOVAs were used to compare the sectors and multiple linear regression analysis tested the association of regard with attribution beliefs , emotional reactions and other characteristics of healthcare professionals .
RESULTS	Regard for working with patients with substance use disorders was different between the three sectors ( GPs M = 42.00 ; general psychiatry M = 48.18 ; addiction specialists M = 55.41 ; p = 0.00 , ( 2 ) = 0.40 ) .
RESULTS	Attribution of personal responsibility and feeling of anger and fear were associated with lower regard scores .
RESULTS	More familiarity with substance use problems , higher frequency of working with this patients group and more confidence in substance abuse treatment were positively associated with regard .
RESULTS	Social desirability bias was present and was positively related to healthcare professionals ' regard .
CONCLUSIONS	Health care professionals of specialist addiction services showed higher regard for working with patients with substance use disorders compared to professionals of general psychiatry services and GPs .
CONCLUSIONS	Improvement of education and shared care models in which healthcare professionals are supported by professionals specializing in addiction might address low regard .

###21681125
BACKGROUND	The almost single disadvantage of conventional polyurethane film dressings , uncontrolled leakage , is probably as often described as its numerous advantages for split-thickness skin graft donor sites .
BACKGROUND	This shortcoming can be overcome by perforating the polyurethane dressing , which permits controlled leakage into a secondary absorbent dressing .
BACKGROUND	The study was conducted to compare the polyurethane dressing system and Aquacel , a hydrofiber wound dressing , which also seems to fulfill all criteria of an ideal donor-site dressing .
METHODS	This prospective , randomized , double-blind clinical trial included 50 adult patients .
METHODS	Skin graft donor sites were divided equally for the application of Aquacel and polyurethane dressing .
METHODS	The dressings were kept unchanged for 10 days .
METHODS	After removal of the dressing at day 10 , the epithelialization rate of both sites was evaluated .
METHODS	Pain scores were assessed according to a 0 to 5 numeric pain scale every postoperative day and during dressing removal .
RESULTS	On postoperative day 10 , 86.4 percent of the polyurethane dressing donor sites showed complete reepithelialization compared with 54.5 percent of the Aquacel-treated donor sites ( p < 0.001 ) .
RESULTS	Polyurethane dressing was significantly less painful until and during removal of the dressing ( p < 0.001 ) .
RESULTS	There was no significant difference with respect to scar formation .
CONCLUSIONS	Overall , polyurethane dressing was superior to Aquacel .
CONCLUSIONS	Further attributes of the polyurethane dressing such as ease of application , low labor input , high patient comfort , and protection against secondary wound infection qualify this dressing system as an ideal wound covering for donor sites .
METHODS	Therapeutic , II .

###17353580
OBJECTIVE	This study was designed to determine the composition of postprandial triglyceride-rich lipoproteins ( TRL ) after the intake of pomace olive oil ( POO ) , which is a subproduct of the extraction of virgin olive oil ( VOO ) and presents a high concentration of minor components with biological activity .
METHODS	Meals enriched in POO and refined olive oil ( ROO ) were administrated to 9 healthy young men and blood was extracted every hour during a postprandial period of 7 hours .
METHODS	Serum and TRL lipid composition were measured by enzymatic and chromatographic methods and apolipoprotein B composition by SDS-PAGE .
RESULTS	POO and ROO showed a very similar fatty acid composition but differed in their unsaponifiable fraction .
RESULTS	The content of phytosterols , tocopherols , terpenic acids and alcohols and fatty alcohols was much higher in POO than in ROO .
RESULTS	Serum lipids were not affected by the administration of the oils but the triglyceride concentration in TRL and the size of the particles ( p < 0.05 ) after POO was higher at time point 2 h and lower at time point 4 h compared with ROO .
RESULTS	In contrast , the number of TRL particles was lower after POO , although the rate of clearance was similar .
CONCLUSIONS	We suggest that the unsaponifiable fraction between the two olive oils affect the size and composition of postprandial TRL , which might have a relevant impact on their atherogenicity .

###21166928
OBJECTIVE	To test the hypothesis that : ( i ) functional microvascular dilator capacity is independently associated with insulin sensitivity and age in individuals with central adiposity at risk of cardiovascular disease ( CVD ) ; and ( ii ) functional microvascular dilator capacity is improved by high dose statin treatment .
METHODS	Functional dilator capacity ( measured as change in laser Doppler blood flux from baseline during post occlusive reactive hyperemia [ peak flux % resting flux ; PF % RF ] and flowmotion ( power spectral density [ PSD ] analysis ) ) were assessed in 40 people with central adiposity and one or more other CVD risk factors .
METHODS	Measurements were made at rest and during acute hyperinsulinaemia before and six months after high dose atorvastatin ( 40 mg daily ) or placebo .
RESULTS	Insulin-induced change in PF % RF was independently associated with insulin sensitivity ( M/I ) ( r = 0.46 p = 0.02 ) and age ( r = -0.46 p = 0.02 ) , which together explained almost half of the variance in PF % RF ( adjusted r = 0.37 , p = 0.008 ) .
RESULTS	Whilst atorvastatin decreased LDL cholesterol by 51 % ( p < 0.001 ) , PF % RF and flowmotion remained unchanged .
CONCLUSIONS	Insulin sensitivity and age are independently associated with an insulin-induced change in functional microvascular dilator capacity in individuals with central adiposity at risk of CVD .
CONCLUSIONS	Dilator capacity is not improved by six months high dose statin treatment .

###11205095
OBJECTIVE	To compare the effectiveness of two different stop smoking interventions .
METHODS	A randomised , controlled trial .
METHODS	Results based on intention to treat .
METHODS	Three towns in the south-eastern part of Norway .
METHODS	Visits to GP for `` practice as usual '' ( GP group ) or participation in the behavioural programme SmokEnders ( SE group ) with follow-up 2 weeks , 2 months and 1 year after an agreed stopping date .
METHODS	139 smokers recruited through open invitation .
METHODS	Self-reported smoking stop rate 2 weeks , 2 months and 1 year after an agreed stopping date , completed with biochemical indicators by the 1-year registration .
RESULTS	Two weeks after the agreed cessation date , 10/70 ( 14 % ) of the GP group and 46/69 ( 67 % ) of the SE group had stopped smoking .
RESULTS	After 2 months , 9/70 ( 13 % ) in the GP group and 37/69 ( 54 % ) in the SE group were non-smokers .
RESULTS	One year after cessation 5/70 ( 7 % ) in the GP group and 21/69 ( 30 % ) in the SE group were non-smokers .
CONCLUSIONS	Both interventions were effective as measured by the smoking cessation rate .
CONCLUSIONS	However , the intervention in the SE group was considerably more effective than in the GP group , which suffered from a sizeable number of drop-outs .

###16028147
BACKGROUND	Dihydroartemisinin-piperaquine ( DP ) is a fixed-combination antimalarial drug increasingly deployed in Southeast Asia .
BACKGROUND	The current regimen involves 4 doses given over 3 days .
BACKGROUND	Simplification of the dose regimen should facilitate treatment adherence and thereby increase effectiveness .
METHODS	In a randomized , controlled , 3-arm trial conducted along the northwestern border of Thailand , the standard 4-dose course of DP ( DP4 ) was compared to an equivalent dose given as a once-daily regimen ( DP3 ) and to the standard treatment of mefloquine-artesunate ( MAS3 ) .
RESULTS	A total of 499 patients were included in the study .
RESULTS	Times to fever and parasite clearance were similar in all groups .
RESULTS	The PCR genotyping-adjusted cure rates at day 63 after treatment initiation were 95.7 % ( 95 % confidence interval [ 95 % CI ] , 92.2 % -98.9 % ) for MAS3 , 100 % for DP4 , and 99.4 % ( 95 % CI , 98.1 % -100 % ) for DP3 .
RESULTS	The DP4 and DP3 cure rates were significantly higher than that for MAS3 ( P = .008 and P = .03 , respectively ) .
RESULTS	All regimens were well tolerated .
RESULTS	There were 3 deaths ( 1 in the MAS3 group and 2 in the DP3 group ) , all of which were considered to be unrelated to treatment .
RESULTS	Rates of other adverse events were comparable between the groups , except for diarrhea , which was more common in the DP4 group ( P = .05 vs. the MAS3 group ) .
CONCLUSIONS	A once-daily , 3-dose regimen of DP is a highly efficacious treatment for multidrug-resistant falciparum malaria .
CONCLUSIONS	This simple , safe , and relatively inexpensive fixed combination could become the treatment of choice for falciparum malaria .

###11678838
OBJECTIVE	Computers are a part of everyday life and offer an exciting way of learning .
OBJECTIVE	The aim of our study was to determine the effectiveness of teaching undergraduate endocrinology using a Computer Assisted Learning ( CAL ) programme .
METHODS	One hundred and eighty-five first year clinical medical students were randomly assigned either to attend a series of conventional lectures ( n = 77 ) or to have the same material available through a CAL programme .
METHODS	A multiple choice question examination was performed before and after the course .
METHODS	Lecture attendance and individual usage of the computer system were recorded .
METHODS	Students were asked to fill in an evaluation form at the end of the study .
RESULTS	There was no significant difference in the first examination scores between the groups .
RESULTS	Both groups improved their scores after the course .
RESULTS	Students spent longer performing CAL than attending lectures .
RESULTS	Those who scored lowest in the first examination spent the most time on the CAL course .
RESULTS	Those who spent the most time on the CAL course showed the largest improvement in examination score .
RESULTS	Thirty-six out of the 42 students , who completed an evaluation of the CAL programme , rated it better than the standard lectures .
CONCLUSIONS	Computer assisted learning is an effective way of increasing knowledge in teaching undergraduate endocrinology .
CONCLUSIONS	The course was easy to run and was valued more highly than conventional lectures .
CONCLUSIONS	The module is now running routinely in the year 3 clinical firms at St Thomas ' and has resulted in an increase in knowledge in the end of firm assessment .

###11178767
BACKGROUND	The influence of surgical operations on the systemic immune response is proportional to the degree of trauma .
BACKGROUND	Ultrasonic surgery can dissect structures and divide vessels by the effect produced by vibrations in the tissues .
BACKGROUND	It is believed to be less traumatic than the more commonly used monopolar electrosurgery .
BACKGROUND	This randomized study compares the systemic immune response after laparoscopic cholecystectomy performed using either ultrasonic energy or monopolar electrosurgery .
METHODS	Eighteen patients scheduled for elective laparoscopic cholecystectomy were randomly assigned to treatment using either a harmonic scalpel and clips or monopolar electrosurgery and clips .
METHODS	Postoperative inflammatory response was assessed via changes in the white blood cell count and levels of C-reactive protein .
METHODS	Postoperative immune function was assessed by measuring monocyte HLA-DR expression .
RESULTS	Both the harmonic scalpel and the use of monopolar electrosurgery resulted in activation of the systemic immune response .
RESULTS	No significant differences between the two groups were observed .
CONCLUSIONS	The harmonic scalpel and monopolar electrosurgery are equally traumatic in terms of activation of the systemic immune response .

###11847596
OBJECTIVE	Surface-modifying additives ( SMA ) have been suggested for improving cardiopulmonary bypass ( CPB ) circuit biocompatibility , potentially minimizing inflammatory complications and bleeding associated with CPB .
OBJECTIVE	The purpose of this prospective , randomized clinical study was to compare a novel copolymer surface-modified CPB circuit ( SMARXT ; COBE Cardiovascular ) against the unmodified circuit .
METHODS	We randomized 122 patients with isolated coronary artery disease subjected to first-time surgery on CPB into either the SMA ( n = 62 ) or the control group ( n = 60 ) .
METHODS	Exclusion criteria included renal insufficiency , liver disease , coagulopathy , anticoagulation therapy < 6 days preop , carotid artery stenosis > 70 % , and a history of stroke .
METHODS	We collected perioperative clinical data including drainage blood loss , transfusion requirements , duration of mechanical ventilation , and ICU stay .
METHODS	Platelet function was determined pre - and post-CPB .
RESULTS	SMA patients received 3.2 + / - 0.9 ( SD ) grafts during 48 + / - 16 min of aortic cross clamp and 91 + / - 30 min CPB ( Control : 3.0 + / - 0.9 grafts ; p = 0.33 , 46 + / - 14 min AXC ; p = 0.36 , and 84 + / - 23 min CPB ; p = 0.14 ) .
RESULTS	In the SMA group , 23 patients ( 37 % ) received red blood-cell transfusions , 9 patients ( 15 % ) fresh frozen plasma , and 3 patients ( 5 % ) received platelets ( control : n = 27 [ 46 % ] , p = 0.44 ; n = 10 [ 17 % ] , p = 0.91 ; and n = 4 [ 7 % ] , p = 0.71 , respectively ) .
RESULTS	Platelet count on CPB fell to the same level in both groups .
RESULTS	In SMA patients , platelet function decreased from 94.2 + / - 24.9 % pre-CPB to 79.5 + / - 32.8 % post-CPB ( p = 0.043 ) ( control : from 87.7 + / - 25.6 % to 69.4 + / - 34.7 % ; p = 0.001 ) .
RESULTS	Postoperative drainage blood loss , mechanical ventilation duration , and ICU stay were similar in both groups ( p > 0.3 ) .
RESULTS	One patient of the control group was excluded due to surgical bleeding , and one SMA patient died .
CONCLUSIONS	Our results show that the surface-modified CPB circuit decreased neither blood loss nor transfusions despite slightly better platelet function preservation compared to the unmodified circuit .
CONCLUSIONS	This type of CPB circuit surface modification does not appear to improve clinical outcome in low-risk coronary artery surgery patients .

###20722643
OBJECTIVE	We studied the efficacy of 25-microg misoprostol pessaries as either single or double dose compared with a 3-mg dinoprostone pessary for cervical priming .
METHODS	A randomised controlled trial in Singapore .
METHODS	One hundred and seventy-one women with term pregnancies and modified Bishop scores ( mBS ) < or = 6 from 2003 to 2004 .
METHODS	Patients were randomised to single misoprostol dose , double misoprostol dose or the current dinoprostone regimen .
METHODS	Primary outcome was number of women who achieved favourable mBS > 6 or active labour by day 2 .
METHODS	Secondary outcomes were time interval from insertion to delivery , cardiotocographic abnormalities , delivery and neonatal outcome .
RESULTS	More women in the misoprostol double-dose group ( 96.6 % ) and dinoprostone group ( 93 % ) achieved the primary outcome compared with the single-dose group ( 77.8 % ) ( P = 0.003 and P = 0.03 , respectively ) .
RESULTS	There was no difference in secondary outcomes .
RESULTS	More multiparous women achieve primary outcome compared with nulliparous women ( odds ratio 0.21 , 95 % confidence interval 0.06-0 .77 ) .
CONCLUSIONS	Double-dose misoprostol 25 microg is as effective as dinoprostone 3 mg inserts for cervical priming ; both are more efficacious than a single-dose misoprostol pessary .
CONCLUSIONS	Parity prognosticates the success of induction .

###24065010
OBJECTIVE	Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes .
OBJECTIVE	Sensor-augmented insulin pump with automated low-glucose insulin suspension has the potential to reduce the incidence of major hypoglycemic events .
OBJECTIVE	To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy .
METHODS	A randomized clinical trial involving 95 patients with type 1 diabetes , recruited from December 2009 to January 2012 in Australia .
METHODS	Patients were randomized to insulin pump only or automated insulin suspension for 6 months .
METHODS	The primary outcome was the combined incidence of severe ( hypoglycemic seizure or coma ) and moderate hypoglycemia ( an event requiring assistance for treatment ) .
METHODS	In a subgroup , counterregulatory hormone responses to hypoglycemia were assessed using the hypoglycemic clamp technique .
RESULTS	Of the 95 patients randomized , 49 were assigned to the standard-pump ( pump-only ) therapy and 46 to the low-glucose suspension group .
RESULTS	The mean ( SD ) age was 18.6 ( 11.8 ) years ; duration of diabetes , 11.0 ( 8.9 ) years ; and duration of pump therapy , 4.1 ( 3.4 ) years .
RESULTS	The baseline rate of severe and moderate hypoglycemic events in the pump-only group was 20.7 vs 129.6 events per 100 patient months in the low-glucose suspension group .
RESULTS	After 6 months of treatment , the event rates decreased from 28 to 16 in the pump-only group vs 175 to 35 in the low-glucose suspension group .
RESULTS	The adjusted incidence rate per 100 patient-months was 34.2 ( 95 % CI , 22.0-53 .3 ) for the pump-only group vs 9.5 ( 95 % CI , 5.2-17 .4 ) for the low-glucose suspension group .
RESULTS	The incidence rate ratio was 3.6 ( 95 % CI , 1.7-7 .5 ; P < .001 ) .
RESULTS	There was no change in glycated hemoglobin in either group : mean , 7.4 ( 95 % CI , 7.2-7 .6 ) to 7.4 ( 95 % CI , 7.2-7 .7 ) in the pump-only group vs mean , 7.6 ( 95 % , CI , 7.4-7 .9 ) to 7.5 ( 95 % CI , 7.3-7 .7 ) in the low-glucose suspension group .
RESULTS	Counterregulatory hormone responses to hypoglycemia were not changed .
RESULTS	There were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis .
CONCLUSIONS	Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes .
BACKGROUND	anzctr.org.au Identifier : ACTRN12610000024044 .

###22898678
BACKGROUND	No effective standard treatment exists for patients with radioiodine-refractory , advanced differentiated thyroid carcinoma .
BACKGROUND	We aimed to assess efficacy and safety of vandetanib , a tyrosine kinase inhibitor of RET , VEGFR and EGFR signalling , in this setting .
METHODS	In this randomised , double-blind , phase 2 trial , we enrolled adults ( aged 18 years ) with locally advanced or metastatic differentiated thyroid carcinoma ( papillary , follicular , or poorly differentiated ) at 16 European medical centres .
METHODS	Eligible patients were sequentially randomised in a 1:1 ratio with a standard computerised scheme to receive either vandetanib 300 mg per day ( vandetanib group ) or matched placebo ( placebo group ) , balanced by centre .
METHODS	The primary endpoint was progression-free survival ( PFS ) in the intention-to-treat population based on investigator assessment .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00537095 .
RESULTS	Between Sept 28 , 2007 , and Oct 16 , 2008 , we randomly allocated 72 patients to the vandetanib group and 73 patients to the placebo group .
RESULTS	By data cutoff ( Dec 2 , 2009 ) , 113 ( 78 % ) patients had progressed ( 52 [ 72 % ] patients in the vandetanib group and 61 [ 84 % ] in the placebo group ) and 40 ( 28 % ) had died ( 19 [ 26 % ] patients in the vandetanib group and 21 [ 29 % ] in the placebo group ) .
RESULTS	Patients who received vandetanib had longer PFS than did those who received placebo ( hazard ratio [ HR ] 063 , 60 % CI 054-074 ; one-sided p = 0008 ) : median PFS was 111 months ( 95 % CI 77-140 ) for patients in the vandetanib group and 59 months ( 40-89 ) for patients in the placebo group .
RESULTS	The most common grade 3 or worse adverse events were QTc prolongation ( ten [ 14 % ] of 73 patients in the vandetanib group vs none in the placebo group ) , diarrhoea ( seven [ 10 % ] vs none ) , asthenia ( five [ 7 % ] vs three [ 4 % ] ) , and fatigue ( four [ 5 % ] vs none ) .
RESULTS	Two patients in the vandetanib group and one in the placebo group died from treatment-related serious adverse events ( haemorrhage from skin metastases and pneumonia in the vandetanib group and pneumonia in the placebo group ) .
CONCLUSIONS	Vandetanib is the first targeted drug to show evidence of efficacy in a randomised phase 2 trial in patients with locally advanced or metastatic differentiated thyroid carcinoma .
CONCLUSIONS	Further investigation of tyrosine-kinase inhibitors in this setting is warranted .
BACKGROUND	AstraZeneca .

###19815466
BACKGROUND	Pancreatic enzyme replacement therapy is critical for adequate nutrition in cystic fibrosis ( CF ) patients with exocrine pancreatic insufficiency ( EPI ) .
METHODS	This was a double-blind , randomised , placebo-controlled , two-period crossover study assessing efficacy and safety of Creon 24,000-unit capsules in CF subjects > or = 12 years with EPI .
METHODS	Patients were randomised to one of two 5-day sequences , Creon/placebo or placebo/Creon ( target dose , 4000 lipase units/g fat ) .
METHODS	Primary outcome was the coefficient of fat absorption ( CFA ) ; secondary outcomes were coefficient of nitrogen absorption ( CNA ) , symptoms , and safety .
RESULTS	Thirty-two subjects were randomised .
RESULTS	Mean CFA and CNA were significantly greater with Creon than placebo ( CFA , 88.6 % vs. 49.6 % ; CNA , 85.1 % vs. 49.9 % ; p < 0.001 for both ) .
RESULTS	Symptoms were improved and fewer treatment-emergent adverse events were reported with Creon than placebo .
RESULTS	One patient discontinued for weight loss unrelated to study drug .
CONCLUSIONS	This study demonstrated Creon was effective in treating EPI due to CF and was safe and well tolerated .

###18414111
OBJECTIVE	To compare the ocular hypotensive effect and safety of brinzolamide and timolol added to latanoprost monotherapy .
METHODS	In prospective randomized fashion , we evaluated the ocular hypotensive effect and safety of brinzolamide or timolol in 1 eye of 32 patients with primary open-angle glaucoma , normal-tension glaucoma , or ocular hypertension who had been treated with latanoprost for more than 1 month .
METHODS	Intraocular pressure ( IOP ) , blood pressure , and pulse were measured before and at 4 , 8 , and 12 weeks .
METHODS	Corneal endothelial cell density was measured at baseline and at 12 weeks .
RESULTS	The IOP was 17.8 + / -1.7 mm Hg ( mean + / - SD ) before the addition of brinzolamide ( n = 15 ) and 15.7 + / -2.1 mm Hg at 12 weeks ( P < 0.01 ) .
RESULTS	In comparison , the IOP was 18.5 + / -3.7 mm Hg before the addition of timolol ( n = 15 ) and 15.8 + / -3.2 mm Hg at 12 weeks ( P < 0.01 ) .
RESULTS	Both brinzolamide and timolol significantly decreased IOP at 12 weeks , by a mean of 2.0 mm Hg and mean 2.7 mm Hg , respectively , and were more effective than latanoprost alone ( P < 0.01 ) , but there were no significant differences between the drugs and no significant differences in corneal endothelial cell density and blood pressure before and after addition of either drug .
RESULTS	At 12 weeks , pulse was decreased in patients receiving timolol ( P < 0.01 ) .
RESULTS	As systemic adverse events , there was one instance of malar flushing after brinzolamide addition and episodes of chest discomfort after timolol addition in 1 patient .
RESULTS	Ocular adverse events were slight .
CONCLUSIONS	Brinzolamide and timolol added to latanoprost have similar ocular hypotensive effects and safety in primary open-angle glaucoma , normal-tension glaucoma , or ocular hypertension .

###11679455
OBJECTIVE	To compare management based on maternal glycemic criteria with management based on relaxed glycemic criteria and fetal abdominal circumference ( AC ) measurements in order to select patients for insulin treatment of gestational diabetes mellitus ( GDM ) with fasting hyperglycemia .
METHODS	In a pilot study , 98 women with fasting plasma glucose ( FPG ) concentrations of 105-120 mg/dl were randomized .
METHODS	The standard group received insulin treatment .
METHODS	The experimental group received insulin if the AC , measured monthly , was > or = 70th percentile and/or if any venous FPG measurement was > 120 mg/dl .
METHODS	Power was projected to detect a 250-g difference in birth weights .
RESULTS	Gestational ages , maternal glycemia , and AC percentiles were similar at randomization .
RESULTS	After initiation of protocol , venous FPG ( P = 0.003 ) and capillary blood glucose levels ( P = 0.049 ) were significantly lower in the standard group .
RESULTS	Birth weights ( 3,271 + / - 458 vs. 3,369 + / - 461 g ) , frequencies of birth weights > 90th percentile ( 6.3 vs 8.3 % ) , and neonatal morbidity ( 25 vs. 25 % ) did not differ significantly between the standard and experimental groups , respectively .
RESULTS	The cesarean delivery rate was significantly lower ( 14.6 vs. 33.3 % , P = 0.03 ) in the standard group ; this difference was not explained by birth weights .
RESULTS	In the experimental group , infants of women who did not receive insulin had lower birth weights than infants of mothers treated with insulin ( 3,180 + / - 425 vs. 3,482 + / - 451 g , P = 0.03 ) .
CONCLUSIONS	In women with GDM and fasting hyperglycemia , glucose plus fetal AC measurements identified pregnancies at low risk for macrosomia and resulted in the avoidance of insulin therapy in 38 % of patients without increasing rates of neonatal morbidity .

###16965992
OBJECTIVE	Erectile dysfunction after three-dimensional conformal external-beam radiotherapy ( 3DCRT ) for prostatic carcinoma is reported in as many as 64 % of those patients .
OBJECTIVE	The purpose of this study was to determine the efficacy of the oral drug tadalafil ( Cialis ) in patients with erectile dysfunction after radiotherapy for prostatic carcinoma .
METHODS	Patients ( N = 358 ) who completed radiotherapy at least 12 months before the study were approached by mail .
METHODS	All patients had been treated by 3DCRT ; 60 patients were included and entered a double-blind , placebo-controlled , cross-over study lasting 12 weeks .
METHODS	They received 20 mg of tadalafil or placebo for 6 weeks .
METHODS	Drug or placebo was taken on demand at patient 's discretion , with no restrictions regarding the consumption of alcohol or food , at least once a week and no more than once daily .
METHODS	At 6 weeks patients crossed over to the alternative treatment .
METHODS	Data were collected using the Sexual Encounter Profile ( SEP ) and the International Index of Erectile Function ( IIEF ) questionnaires .
METHODS	Side effects were also recorded .
RESULTS	Mean age at study entry was 69 years .
RESULTS	All patients completed the study .
RESULTS	For almost all questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with tadalafil , but not with placebo .
RESULTS	Sixty-seven percent of the patients reported an improvement of erectile function with tadalafil ( placebo : 20 % ) , and 48 % reported successful intercourse with tadalafil ( placebo : 9 % ) ( p < 0.0001 ) .
RESULTS	Side effects were mild or moderate .
CONCLUSIONS	Tadalafil is an effective treatment for erectile dysfunction after 3DCRT for prostatic carcinoma with successful intercourse reported in almost 50 % of the patients , and it is well tolerated .

###24449961
OBJECTIVE	To assess whether the addition of a peer testimonial to an informational mailing increases conversion rates from brand name prescription medications to lower-cost therapeutic equivalents , and whether the testimonial 's efficacy increases when information is added about an affiliation the quoted individual shares with the recipient .
METHODS	A total of 5498 union members were randomly assigned to receive 1 of 3 different informational letters : 1 without a testimonial ( No Testimonial Group ) , 1 with a testimonial from a person whose shared union affiliation with the recipient was not disclosed ( Unaffiliated Testimonial Group ) , and 1 with a testimonial from a person whose shared union affiliation with the recipient was disclosed ( Affiliated Testimonial Group ) .
RESULTS	The conversion rate for the No Testimonial Group was 12.2 % , which is higher than the Unaffiliated Testimonial Group rate of 11.3 % and the Affiliated Testimonial Group rate of 11.7 % .
RESULTS	The differences between the groups are not statistically significant .
CONCLUSIONS	Short peer testimonials do not increase the impact of a mailed communication on conversion rates to lower-cost , therapeutically equivalent medications , even when the testimonial is presented as coming from a more socially proximate peer

###19165497
OBJECTIVE	The present randomised pilot trial was designed to compare robot-assisted ( RALF ) and conventional laparoscopic fundoplication ( CLF ) focussing on post-operative quality of life ( QOL ) and functional outcome .
OBJECTIVE	Any long-lasting advantages for patients in this regard could be a justification for the use of RALF for the treatment of gastroesophageal reflux disease ( GERD ) .
METHODS	Forty patients with GERD were randomised to either RALF or to CLF .
METHODS	During a follow-up period of 12 months , patients ' QOL and functional outcome were investigated using disease-specific questionnaires .
RESULTS	There were no significant differences in the mean QOL ( 1.3 versus 1.1 ; P = 0.374 ) and functional outcome ( 1.27 versus 1.3 ; P = 0.913 ) between both groups .
RESULTS	Minor side effects such as bloating and persistent diarrhoea were present in four patients of each group .
CONCLUSIONS	The present study did not show any benefit for RALF over CLF regarding QOL and functional outcome at 12 months ' follow-up .

###11322207
BACKGROUND	In chronic hepatitis C the schedule of interferon ( IFN ) , 3 MU thrice weekly ( tiw ) plus ribavirin ( 1000-1200 mg/daily ) needs further evaluation , as IFN dosages > 3 MU achieve better responses .
OBJECTIVE	To compare the efficacy of 5 MU tiw of IFN with ( 96 patients ) or without ribavirin ( 96 patients ) for 12 months in nave patients , to evaluate the effect of baseline features on the response to therapy , and to determine a reliable point in time during treatment to predict non-response .
RESULTS	Sustained virologic response was 20.8 % ( 95 % CI 13-29 ) with IFN monotherapy and 54.2 % ( 95 % CI 44-64 ) with combination ( P = 0.0001 ) , the relapse rate 39.4 % ( 95 % CI 23-56 ) and 9 % ( 95 % CI 1-16 ) ( P = 0.0007 ) , and the combined rate of sustained biochemical and virologic response 22.7 % ( 95 % CI 14-31 ) and 60.5 % ( 95 % CI 50-71 ) ( P = 0.0001 ) , respectively .
RESULTS	Patients given combination therapy were more likely to respond regardless of baseline features .
RESULTS	Apart from genotype non-1 , predictive factors for IFN monotherapy were ineffective in predicting response to combination therapy .
RESULTS	Using logistic regression analysis , IFN-ribavirin was the strongest predictor of response ( X2 = 21.3 ; P = 0.0001 ) .
RESULTS	Viral persistence at month 3 of therapy was a more accurate predictor than aminotransferase values for non-response to IFN monotherapy but not to combination therapy ( positive predictive values of 98 and 82 % , respectively ) .
CONCLUSIONS	In this study , 5 MU of IFN combined with a standard dose of ribavirin has yielded the highest rate of sustained response reported to date .
CONCLUSIONS	Further dose finding studies are warranted .

###7852065
OBJECTIVE	To compare four analgesic regimens used in preparing patients for chest tube removal .
METHODS	Prospective , randomized , controlled multiple-group comparison .
METHODS	Mid-atlantic university affiliated tertiary medical center .
METHODS	80 adult patients who underwent heart surgery and who had two mediastinal chest tubes .
METHODS	Subject 's pain intensity rating on a 0 to 100 mm visual analog scale and subject 's description of sensations blindly rated by six nurses .
METHODS	Before chest tube removal , subjects were medicated with either : ( 1 ) intravenous morphine sulfate ( morphine ) , ( 2 ) intravenous morphine and subfascial angiocatheter lidocaine hydrochloride ( lidocaine ) , ( 3 ) intravenous morphine and subfascial angiocatheter normal saline solution , or ( 4 ) subfascial angiocatheter lidocaine .
RESULTS	Mean pain rating scores for groups 1 , 2 , 3 , and 4 were 43.7 40.9 , 36.4 , and 38.1 , respectively .
RESULTS	Analysis of variance showed no significant difference between scores ( p = 0.8948 ) .
RESULTS	The percentage of comments rated as `` not bad at all '' or `` not bad '' for groups 1 , 2 , 3 , and 4 were 56 % , 83 % , 47 % and 75 % , respectively .
RESULTS	Chi-square analysis showed a significant difference between ratings ( p < 0.01 ) .
CONCLUSIONS	Blind ratings of subjects ' descriptions of sensations suggest subfascial lidocaine may be useful in reducing discomfort during chest tube removal .

###23645476
BACKGROUND	Patients with chronic kidney disease ( CKD ) are at risk for progression to kidney failure .
BACKGROUND	Using data of Canadian CKD patients , Tangri et al. recently developed models to predict the progression of CKD stages 3-5 to kidney failure within 5 years .
BACKGROUND	We validated this kidney failure risk equation ( KFRE ) in European CKD patients .
METHODS	We selected non-transplanted patients with CKD stages 3-5 who participated in the MASTERPLAN study , a randomized controlled trial in patients with CKD .
METHODS	Kidney failure was defined as the initiation of chronic dialysis or kidney transplantation within 5 years .
METHODS	Patients who died before kidney failure were censored .
METHODS	Patients followed for < 5 years , who did not develop kidney failure and did not die , were excluded .
METHODS	The 5-year kidney failure risk was predicted using three different models developed by Tangri et al. and compared with the actual kidney failure rate in MASTERPLAN .
METHODS	Model performance was evaluated using the area under the receiver operating characteristic curve ( ROC-AUC ) , the net reclassification index ( NRI ) and by comparing the observed and predicted rates of kidney failure .
RESULTS	A total of 595 patients were included ; 114 developed kidney failure .
RESULTS	( Overall observed kidney failure risk in our cohort was 5 % lower than in the Canadian validation cohort . )
RESULTS	Discrimination of the eight-variable model [ including age , sex , estimated glomerular filtration rate ( eGFR ) , albuminuria , calcium , phosphate , bicarbonate , albumin ] was similar to that of the four-variable model ( including age , sex , eGFR , albuminuria ) and the three-variable model ( including age , sex , eGFR ) ; ROC-AUCs were 0.89 [ 95 % confidence interval ( CI ) 0.86-0 .92 ] , 0.88 ( 95 % CI 0.85-0 .91 ) and 0.88 ( 95 % CI 0.85-0 .92 ) , respectively .
RESULTS	Using the NRI , the eight-variable model slightly outperformed the four-variable model ( NRI 6.5 % ) and the three-variable model ( NRI 12.4 % ) .
RESULTS	The mean differences between the observed and predicted kidney failure risk were -4.0 , -7.1 and -7.4 % for the eight - , four - , and three-variable model , respectively .
CONCLUSIONS	The KFRE accurately predicted the progression to kidney failure in European CKD patients .
CONCLUSIONS	Discrimination of the three models was similar .
CONCLUSIONS	Calibration of the eight-variable model was slightly better than that of the simpler models .
CONCLUSIONS	We question whether this outweighs its added complexity .

###14644225
OBJECTIVE	To examine whether objective performance of near tasks is improved with various electronic vision enhancement systems ( EVES ) compared with the subject 's own optical magnifier .
METHODS	Experimental study , randomized , within-patient design .
METHODS	This was a prospective study , conducted in a hospital ophthalmology low-vision clinic .
METHODS	The patient population comprised 70 sequential visually impaired subjects .
METHODS	The magnifying devices examined were : patient 's optimum optical magnifier ; magnification and field-of-view matched mouse EVES with monitor or head-mounted display ( HMD ) viewing ; and stand EVES with monitor viewing .
METHODS	The tasks performed were : reading speed and acuity ; time taken to track from one column of print to the next ; follow a route map , and locate a specific feature ; and identification of specific information from a medicine label .
RESULTS	Mouse EVES with HMD viewing caused lower reading speeds than stand EVES with monitor viewing ( F = 38.7 , P < .001 ) .
RESULTS	Reading with the optical magnifier was slower than with the mouse or stand EVES with monitor viewing at smaller print sizes ( P < .05 ) .
RESULTS	The column location task was faster with the optical magnifier than with any of the EVES ( F = 10.3 , P < .001 ) .
RESULTS	The map tracking and medicine label identification task was slower with the mouse EVES with HMD viewing than with the other magnifiers ( P < .01 ) .
RESULTS	Previous EVES experience had no effect on task performance ( P > .05 ) , but subjects with previous optical magnifier experience were significantly slower at performing the medicine label identification task with all of the EVES ( P < .05 ) .
CONCLUSIONS	Although EVES provide objective benefits to the visually impaired in reading speed and acuity , together with some specific near tasks , some can be performed just as fast using optical magnification .

###20678673
BACKGROUND	Currently approved Alzheimer 's disease ( AD ) treatments have been reported to provide symptomatic benefit , without proven impact on clinical progression .
BACKGROUND	We hypothesized that the loss of initial therapeutic benefit over time may be mitigated by higher doses of a cholinesterase inhibitor .
OBJECTIVE	The aim of this study was to determine the effectiveness and tolerability of increasing donepezil from 10 to 23 mg/d in patients with moderate to severe AD .
METHODS	This randomized , double-blind study was conducted at 219 sites in Asia , Europe , Australia , North America , South Africa , and South America from June 6 , 2007 , to March 27 , 2009 .
METHODS	Patients aged 45 to 90 years with probable AD , Mini-Mental State Examination score 0 to 20 ( moderate to severe impairment ) , and who were receiving donepezil 10 mg once daily for > or = 12 weeks before the start of the study were eligible .
METHODS	Patients ( n = 1467 ) were randomly assigned to receive high-dose donepezil ( 23 mg once daily ) or standard-dose donepezil ( 10 mg once daily ) for 24 weeks .
METHODS	Coprimary effectiveness measures were changes in cognition and global functioning , as assessed using least squares mean changes from baseline ( LSM [ SE ] A ) scores ( last observation carried forward ) on the Severe Impairment Battery ( SIB ; cognition ) and the Clinician 's Interview-Based Impression of Change Plus Caregiver Input scale ( CIBIC + ; global function rating ) overall change score ( mean [ SD ] ) at week 24 .
METHODS	Treatment-emergent adverse events ( TEAEs ) were assessed using spontaneous patient/caregiver reporting and open-ended questioning ; clinical laboratory testing ( hematology , biochemistry , and urinalysis panels analyzed by a central laboratory ) ; 12-lead ECG ; and physical and neurologic examinations , including vital sign measurements .
RESULTS	The effectiveness analyses included 1371 patients ( mean age , 73.8 years ; 62.8 % female ; 73.5 % white ; weight range , 34.0-138 .7 kg ) .
RESULTS	A total of 296 of 981 patients ( 30.2 % ) withdrew from the donepezil 23-mg/d group ; 87 of 486 patients ( 17.9 % ) withdrew from the donepezil 10-mg/d group .
RESULTS	At study end ( week 24 ) , the LSM ( SE ) Delta in SIB score was significantly greater with donepezil 23 mg/d than with donepezil 10 mg/d ( +2.6 [ 0.58 ] vs +0.4 [ 0.66 ] , respectively ; difference , 2.2 ; P < 0.001 ) .
RESULTS	The between-treatment difference in CIBIC + score was nonsignificant ( 4.23 [ 1.07 ] vs 4.29 [ 1.07 ] ) .
RESULTS	In post hoc analysis , LSM Delta in SIB score and CIBIC + treatment effect at end point were greater with donepezil 23 mg/d than 10 mg/d in patients with more advanced AD compared with less impaired patients ( SIB , +1.6 [ 0.78 ] vs -1.5 [ 0.88 ] , respectively [ P < 0.001 ] ; CIBIC + , 4.31 [ 1.09 ] vs 4.42 [ 1.10 ] [ P = 0.028 ] ) .
RESULTS	TEAEs were reported in 710 of 963 patients ( 73.7 % ) who received donepezil 23 mg/d and in 300 of 471 patients ( 63.7 % ) who received donepezil 10 mg/d .
RESULTS	With donepezil 23 mg/d , mild , moderate , and severe TEAEs were reported in 297 ( 30.8 % ) , 332 ( 34.5 % ) , and 81 ( 8.4 % ) patients , respectively ; with donepezil 10 mg/d , these proportions were 147 ( 31.2 % ) , 119 ( 25.3 % ) , and 34 ( 7.2 % ) .
RESULTS	The 3 most common severe AEs reported with the 23-mg/d dose were nausea ( 9 patients [ 0.9 % ] vs 1 [ 0.2 % ] with the 10-mg/d dose ) , dizziness ( 7 [ 0.7 % ] vs 1 [ 0.2 % ] ) , and vomiting ( 6 [ 0.6 % ] vs 0 ) .
RESULTS	The most commonly reported TEAEs considered probably related to treatment with the 23-mg/d dose were nausea ( 59 patients [ 6.1 % ] vs 9 [ 1.9 % ] with the 10-mg/d dose ) , vomiting ( 48 [ 5.0 % ] vs 4 [ 0.8 % ] ) , and diarrhea ( 31 [ 3.2 % ] vs 7 [ 1.5 % ] ) .
RESULTS	Thirteen deaths were reported during the study or within 30 days of study discontinuation ( 23 mg/d , 8 patients [ 0.8 % ] ; 10 mg/d , 5 patients [ 1.1 % ] ) ; all were considered unrelated to the study medication .
CONCLUSIONS	In this study in patients with moderate to severe AD , donepezil 23 mg/d was associated with greater benefits in cognition compared with donepezil 10 mg/d .
CONCLUSIONS	The between-treatment difference in global functioning was not significant in the overall population .
CONCLUSIONS	Patients with more advanced AD appeared to benefit from donepezil 23 mg/d on the assessment of global functioning , but this observation requires additional studies for confirmation .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00478205 .

###12456545
OBJECTIVE	To compare the privately borne and NHS costs of hospital at home ( HAH ) and conventional inpatient care for children with selected acute conditions .
METHODS	Prospective economic evaluation using cost minimisation analysis within a randomised controlled trial , in paediatric wards of a district general hospital , and private homes in the local catchment area in Wirral , Merseyside .
METHODS	Subjects were children who fulfilled the criteria for admission to HAH , suffering from breathing difficulties ( n = 202 ) , diarrhoea and vomiting ( n = 125 ) , or fever ( n = 72 ) .
RESULTS	Direct costs borne by families are reduced by 41 % for HAH patients ( pound 23.31 v pound 13.76 , p = 0.001 ) .
RESULTS	There is no evidence that HAH transfers the burden of care to parents , and there is no difference in absence rates from paid employment .
RESULTS	Patients and their careers expressed a strong preference for HAH .
RESULTS	Comparison of NHS costs is equivocal , depending on how HAH is implemented alongside the conventional hospital service .
CONCLUSIONS	Paediatric HAH schemes are unlikely to reduce NHS costs and do not increase privately borne costs .
CONCLUSIONS	They will , however , significantly increase patient and career satisfaction with care provision for sick children with appropriate conditions .

###12551868
BACKGROUND	This study was designed to investigate long-term effects of the glycoprotein IIb/IIIa inhibitor abciximab in patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention .
RESULTS	A total of 7800 patients were included with an acute coronary syndrome without ST elevation , documented by either elevated cardiac troponin or transient or persistent ST-segment depression .
RESULTS	They were randomized to abciximab bolus and 24-hour infusion , abciximab bolus and 48-hour infusion , or matching placebo .
RESULTS	The overall 1-year mortality rate was 8.3 % ( 649 patients ) .
RESULTS	One-year mortality was 7.8 % in the placebo group and 8.2 % in the 24-hour and 9.0 % in the 48-hour abciximab infusion group .
RESULTS	Compared with placebo , the hazard ratio for the 24-hour infusion of abciximab was 1.1 ( 95 % CI 0.86 to 1.29 ) , and for the 48-hour infusion , it was 1.2 ( 95 % CI 0.95 to 1.41 ) .
RESULTS	The lack of benefit of abciximab was observed in every subgroup studied .
RESULTS	Patients with negative troponin or elevated C-reactive protein had a higher mortality rate after treatment with abciximab for 48 hours than with placebo : 8.5 % versus 5.8 % in those with negative troponin ( P = 0.02 ) , 16.3 % versus 12.1 % in those with elevated C-reactive protein ( P = 0.04 ) .
CONCLUSIONS	Compared with placebo , abciximab did not provide any survival benefit at 1 year in patients admitted with an acute coronary syndrome with ST depression and/or elevated troponin who were not scheduled to undergo early coronary revascularization .
CONCLUSIONS	In subgroups of patients , in particular those with low cardiac troponin or elevated C-reactive protein , abciximab was associated with excess mortality .

###18298579
OBJECTIVE	To determine the effect of food on the antiviral activity of enteric-coated ( EC ) capsules of didanosine ( ddI ) .
METHODS	We conducted a pilot , randomized , open-label study of 28-day ddI-EC capsules monotherapy-administered in a fasted state ( group 1 , n = 11 ) or with food ( group 2 , n = 10 ) to treatment-nave chronically HIV-1-infected individuals .
METHODS	To assess the antiviral efficacy , HIV-1 RNA was determined at baseline , day 3 , day 7 and weekly thereafter .
METHODS	The area under the HIV-1 RNA curve minus baseline weighted by time ( AUCMB/day ) was calculated .
RESULTS	Mean baseline HIV-1 RNA was 4.2 log ( 10 ) copies/mL in group 1 and 3.8 log ( 10 ) copies/mL in group 2 .
RESULTS	After 28 days , the mean HIV-1 RNA reduction was 0.99 log ( 10 ) copies/mL [ 95 % confidence interval ( CI ) 0.45-1 .53 ] for group 1 and 0.89 log ( 10 ) copies/mL ( 95 % CI 0.38-1 .40 ) for group 2 .
RESULTS	AUCMB/day values were 0.775 log ( 10 ) copies/mL ( 95 % CI 0.33-1 .22 ) and 0.774 log ( 10 ) copies/mL ( 95 % CI 0.48-1 .07 ) , respectively , showing no difference in the rate of decrease of HIV-1 RNA ( P = 0.995 ) .
RESULTS	Mean ddI plasma levels at day 28 were 0.0234 mg/L for group 1 and 0.0227 mg/L for group 2 ( P = 0.96 ) .
CONCLUSIONS	In this pilot study , the administration of food did not have any significant effect on the antiviral activity of ddI-EC capsules .

###8829859
OBJECTIVE	The optimal dose of intravenous ketorolac tromethamine ( ketorolac ) , a non-steroidal anti-inflammatory drug has not been determined in children .
OBJECTIVE	There are only limited published data on the use of intravenous ketorolac for paediatric analgesia .
OBJECTIVE	This study compares the analgesic and emetic effect of three different doses of ketorolac with morphine in paediatric dental surgical out-patients .
METHODS	Following institutional approval and parental consent , 120 ASA I or II children , age 2-10 yr were randomized to four groups and received ketorolac 0.75 , 1.0 , and 1.5 mg.kg-1 or morphine 0.1 mg.kg-1 iv at induction of a standardized anaesthetic .
METHODS	At 15 and 30 min after arrival in the recovery room a blinded observer assessed pain using the Objective Pain Score ( OPS ) .
METHODS	Twenty-four hours after surgery a telephone interview was carried out with a parent at home .
RESULTS	There were no differences in demographic data , anaesthesia time , recovery and day-care unit time , OPS and postoperative analgesic requirements in the four groups .
RESULTS	Postoperative vomiting in the first 24 hr occurred more frequently in the morphine group than in the other groups ( P < 0.0166 ) .
RESULTS	No patient had excessive surgical bleeding .
CONCLUSIONS	Ketorolac , in all doses studied ( 0.75 , 1.0 and 1.5 mg.kg-1 ) was as effective an analgesic as morphine 0.1 mg.kg-1 given intravenously at induction to children having restorative dental surgery .
CONCLUSIONS	Its use was associated with a significant reduction in the incidence of postoperative vomiting .

###12428223
OBJECTIVE	To demonstrate the long-term efficacy of anakinra , a human recombinant interleukin-1 receptor antagonist , in patients with rheumatoid arthritis ( RA ) , and to assess the long-term safety of anakinra at different daily doses .
METHODS	The efficacy and safety of anakinra were previously demonstrated in a double-blind , placebo-controlled , 24-week evaluation in 472 patients with active RA .
METHODS	Of 345 patients who completed the placebo-controlled phase of the study , 309 continued in a 52-week , multicenter , double-blind , parallel-group extension phase of the study .
METHODS	Patients received subcutaneous injections of anakinra ( 30 , 75 , or 150 mg ) once daily .
METHODS	Efficacy was assessed among the 309 patients for the first 24 weeks of the extension phase ( 48 weeks total therapy ) , using the American College of Rheumatology composite score ( ACR20 ) , its components , and radiographs of the hands and wrists .
METHODS	Safety was assessed in all 472 patients over the entire 52-week extension phase ( 76 weeks total exposure ) .
RESULTS	A total of 218 patients completed the extension phase .
RESULTS	Of the 91 patients who withdrew prematurely , 46 did so following adverse events , and 26 withdrew because of lack of efficacy .
RESULTS	Among patients receiving anakinra who entered the extension phase , the level of improvement was maintained for 48 weeks .
RESULTS	The ACR20 response was 51 % at week 24 and 46 % at week 48 , and this effect was consistent across all dose groups .
RESULTS	The durability of the response to anakinra was further demonstrated in an evaluation of the sustained ACR20 response , which was similar during the first and second 24-week periods ( 36 % and 42 % , respectively ) .
RESULTS	At week 48 , ACR50 and ACR70 responses were demonstrated in 18 % and 3 % of patients , respectively , who continued taking anakinra ( all dose groups ) and in 20 % and 1 % of patients , respectively , who were originally receiving placebo and then were randomized to all doses of anakinra .
RESULTS	Anakinra was well tolerated for 76 weeks .
RESULTS	The only side effects that appeared to be treatment-related were skin reactions at the injection site .
RESULTS	There was no evidence of decreased tolerance , an increased number of withdrawals , or an increased incidence of clinical complications associated with extended anakinra therapy .
CONCLUSIONS	The clinical benefits of treatment with daily self-administered subcutaneous injections of anakinra in a cohort of patients with active RA were maintained for up to 48 weeks .
CONCLUSIONS	Anakinra was well tolerated over 76 weeks .
CONCLUSIONS	These observations support the long-term use of anakinra for the treatment of patients with RA .

###15665343
OBJECTIVE	To assess retinal function by multifocal electroretinogram ( mfERG ) in children on atropine eye drops for the treatment of myopia .
METHODS	mfERGs were recorded in children receiving atropine eye drops ( n = 48 ) once daily for 2 years and in those receiving placebo eye drops ( n = 57 ) for a similar time .
METHODS	All recordings were performed between the second and third month of cessation of atropine/placebo treatment by a masked investigator .
METHODS	The amplitude and implicit time of the first order kernel ( k1 ) and first slice of the second order kernel ( k21 ) of mfERG responses were used to study the outer and inner retinal function , respectively .
RESULTS	There was no significant reduction in k1 response amplitudes of the atropine group compared to that of the placebo group ( N1 , p = 0.181 ; P1 , p = 0.150 ) .
RESULTS	No significant difference in the k1 response implicit times between the groups was found ( N1 , p = 0.767 ; P1 , p = 0.849 ) .
RESULTS	The differences in the k21 amplitudes and implicit times between the groups were not statistically significant ( k21 amplitude , p = 0.058 ; k21 implicit time , p = 0.156 ) .
CONCLUSIONS	Daily atropine usage over 2 years for the treatment of myopia has no significant effect on retinal function as demonstrated by recordings of mfERG .

###25134858
OBJECTIVE	To identify predictive factors associated with the development of pressure ulcers in patients at risk who receive standardized preventive care .
BACKGROUND	Numerous studies have examined factors that predict risk for pressure ulcer development .
BACKGROUND	Only a few studies identified risk factors associated with pressure ulcer development in hospitalized patients receiving standardized preventive care .
METHODS	Secondary analyses of data collected in a multicentre randomized controlled trial .
METHODS	The sample consisted of 610 consecutive patients at risk for pressure ulcer development ( Braden Score < 17 ) receiving standardized preventive care measures .
METHODS	Patient demographic information , data on skin and risk assessment , medical history and diagnosis were collected during 26months ( December 2007-January 2010 ) .
METHODS	Predictive factors were identified using multivariate statistics .
RESULTS	Pressure ulcers in category II-IV were significantly associated with non-blanchable erythema , urogenital disorders and higher body temperature .
RESULTS	Predictive factors significantly associated with superficial pressure ulcers were admission to an internal medicine ward , incontinence-associated dermatitis , non-blanchable erythema and a lower Braden score .
RESULTS	Superficial sacral pressure ulcers were significantly associated with incontinence-associated dermatitis .
CONCLUSIONS	Despite the standardized preventive measures they received , hospitalized patients with non-blanchable erythema , urogenital disorders and a higher body temperature were at increased risk for developing pressure ulcers .
CONCLUSIONS	Improved identification of at-risk patients can be achieved by taking into account specific predictive factors .
CONCLUSIONS	Even if preventive measures are in place , continuous assessment and tailoring of interventions is necessary in all patients at risk .
CONCLUSIONS	Daily skin observation can be used to continuously monitor the effectiveness of the intervention .

###9594939
BACKGROUND	Dermatophyte infections of the toenail have been difficult to treat , requiring long courses of therapy and having high recurrence rates .
BACKGROUND	New oral antifungal agents with better outcomes and minimal adverse events are needed .
OBJECTIVE	The purpose of this study was to compare two newer antifungal compounds , terbinafine and itraconazole , for efficacy and safety in toenail onychomycosis caused by dermatophytes .
METHODS	The study was randomized and double-blind .
METHODS	It compared 12 weeks of continuous oral treatment with terbinafine 250 mg/day or itraconazole 200 mg/day for confirmed toenail dermatophyte onychomycosis .
METHODS	Clinical symptoms and mycologic outcome were assessed at weeks 4 , 8 , 12 , 24 , 36 , and 48 .
METHODS	A total of 372 patients ( 186 in each group ) with dermatophyte infection confirmed by microscopy and culture were included in the intent-to-treat analysis .
RESULTS	At week 48 , a statistically significantly greater percentage of the terbinafine group than itraconazole group showed negative mycology ( 73 % [ 119 of 163 ] vs 45.8 % [ 77 of 168 ] ; p < 0.0001 ) ( difference = 27.2 % ; 95 % CI = [ 17.0 % , 37.3 % ] ) .
RESULTS	The difference was also confirmed clinically ( p = 0.001 ) in the patients who were clinically cured or had only minimal symptoms at the end of the study ( 76.2 % [ 125 of 164 ] vs 58.1 % [ 100 of 172 ] ) ( difference = 18.1 % ; 95 % CI = [ 8.24 % , 27.9 % ] ) .
RESULTS	The geometric mean length of healthy nail of the big toe was significantly greater in the terbinafine than itraconazole group ( 8.1 vs 6.4 mm ; p = 0.026 ) .
RESULTS	Tolerability was good to very good in almost 90 % of patients in both groups , and all reported adverse events were known for these compounds .
CONCLUSIONS	Terbinafine produced higher rates of clinical and mycologic cure at follow-up than did itraconazole .

###24771090
OBJECTIVE	As glycaemia and the incidence of microvascular diabetes complications follow a log-linear relationship , it becomes increasingly difficult to demonstrate a microvascular benefit of glucose-lowering when the HbA1c level is close to normal .
METHODS	The Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial randomised 12,537 people with diabetes , impaired glucose tolerance or impaired fasting glucose to receive standard glycaemic care or standard care with the addition of basal insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) , targeting a fasting plasma glucose level 5.3 mmol/l .
METHODS	Microvascular outcomes during a median follow-up of 6.2 years were examined in participants whose baseline HbA1c was above or below the median of 6.4 % ( 46.4 mmol/mol ) .
RESULTS	Allocation to the insulin glargine group reduced the incidence of the primary microvascular composite outcome of kidney and eye disease in participants whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ; HR 0.90 [ 95 % CI 0.81 , 0.99 ] ) but not in participants with a lower baseline HbA1c ( HR 1.07 [ 95 % CI 0.95 , 1.20 ] ; p value for interaction 0.031 ) .
RESULTS	In people whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ) , the median post-randomisation change in HbA1c was -0.65 % ( interquartile range -0.16 , -0.91 % ) after allocation to insulin glargine and -0.33 % ( -0.83 , 0.13 % ) after allocation to standard care ( median HbA1c difference 0.33 % ; p < 0.0001 ) .
RESULTS	A smaller median difference of 0.22 % was noted in people whose baseline HbA1c was < 6.4 % ( p < 0.0001 ) .
CONCLUSIONS	In patients with dysglycaemia , intervention targeting normal fasting glucose levels reduced HbA1c and attenuated the risk of microvascular outcomes in participants with a baseline HbA1c level 6.4 % ( 46.4 mmol/mol ) .
CONCLUSIONS	A neutral effect was seen in those with a lower baseline HbA1c level .
BACKGROUND	ClinicalTrials.gov NCT00069784 .

###19088168
BACKGROUND	Dipeptidyl-peptidase-IV ( DPP-4 ) inhibition increases endogenous GLP-1 activity , resulting in improved glycemic control in patients with type 2 diabetes mellitus .
BACKGROUND	The metabolic response may be explained in part by extrapancreatic mechanisms .
OBJECTIVE	We tested the hypothesis that DPP-4 inhibition with vildagliptin elicits changes in adipose tissue and skeletal muscle metabolism .
METHODS	We conducted a randomized , double-blind , crossover study at an academic clinical research center .
METHODS	Twenty patients with type 2 diabetes , body mass index between 28 and 40 kg/m ( 2 ) , participated .
METHODS	INTERVENTION included 7 d treatment with the selective DPP-4 inhibitor vildagliptin or placebo and a standardized test meal on d 7 .
METHODS	Venous DPP-4 activity , catecholamines , free fatty acids , glycerol , glucose , ( pro ) insulin , dialysate glucose , lactate , pyruvate , glycerol were measured .
RESULTS	Fasting and postprandial venous insulin , glucose , glycerol , triglycerides , and free fatty acid concentrations were not different with vildagliptin and with placebo .
RESULTS	Vildagliptin augmented the postprandial increase in plasma norepinephrine .
RESULTS	Furthermore , vildagliptin increased dialysate glycerol and lactate concentrations in adipose tissue while suppressing dialysate lactate and pyruvate concentration in skeletal muscle .
RESULTS	The respiratory quotient increased with meal ingestion but was consistently lower with vildagliptin .
CONCLUSIONS	Our study is the first to suggest that DPP-4 inhibition augments postprandial lipid mobilization and oxidation .
CONCLUSIONS	The response may be explained by sympathetic activation rather than a direct effect on metabolic status .

###23169517
OBJECTIVE	Cabozantinib ( XL184 ) is an orally bioavailable tyrosine kinase inhibitor with activity against MET and vascular endothelial growth factor receptor 2 .
OBJECTIVE	We evaluated the activity of cabozantinib in patients with castration-resistant prostate cancer ( CRPC ) in a phase II randomized discontinuation trial with an expansion cohort .
METHODS	Patients received 100 mg of cabozantinib daily .
METHODS	Those with stable disease per RECIST at 12 weeks were randomly assigned to cabozantinib or placebo .
METHODS	Primary end points were objective response rate at 12 weeks and progression-free survival ( PFS ) after random assignment .
RESULTS	One hundred seventy-one men with CRPC were enrolled .
RESULTS	Random assignment was halted early based on the observed activity of cabozantinib .
RESULTS	Seventy-two percent of patients had regression in soft tissue lesions , whereas 68 % of evaluable patients had improvement on bone scan , including complete resolution in 12 % .
RESULTS	The objective response rate at 12 weeks was 5 % , with stable disease in 75 % of patients .
RESULTS	Thirty-one patients with stable disease at week 12 were randomly assigned .
RESULTS	Median PFS was 23.9 weeks ( 95 % CI , 10.7 to 62.4 weeks ) with cabozantinib and 5.9 weeks ( 95 % CI , 5.4 to 6.6 weeks ) with placebo ( hazard ratio , 0.12 ; P < .001 ) .
RESULTS	Serum total alkaline phosphatase and plasma cross-linked C-terminal telopeptide of type I collagen were reduced by 50 % in 57 % of evaluable patients .
RESULTS	On retrospective review , bone pain improved in 67 % of evaluable patients , with a decrease in narcotic use in 56 % .
RESULTS	The most common grade 3 adverse events were fatigue ( 16 % ) , hypertension ( 12 % ) , and hand-foot syndrome ( 8 % ) .
CONCLUSIONS	Cabozantinib has clinical activity in men with CRPC , including reduction of soft tissue lesions , improvement in PFS , resolution of bone scans , and reductions in bone turnover markers , pain , and narcotic use .

###10584125
OBJECTIVE	To detect a difference in outcome ( disease-specific survival , local tumor progression , late toxicity , quality of life ) after curative radiotherapy for localized prostate cancer in elderly as compared to younger patients .
METHODS	In a retrospective analysis 59 elderly patients ( > 74 years old ) were matched 1:2 with younger patients from the data base according to tumor stage , grading , pre-treatment PSA values and year of radiotherapy .
METHODS	Surviving patients were contacted to fill in a validated questionnaire for quality of life measurement ( EORTC QLQ-C30 ) .
METHODS	Median follow-up for elderly and younger patients was 5.2 and 4.5 years , respectively .
RESULTS	Overall survival at 5 years was 66 % for the elderly and 80 % for younger patients .
RESULTS	Intercurrent deaths were observed more frequently in the elderly population .
RESULTS	There was no age-specific difference in disease-specific survival ( 78 % vs 82 % ) , late toxicity or quality of life .
RESULTS	Clinically meaningful local tumor progression was observed in 15 % and 14 % , respectively , corresponding to data from the literature following hormonal ablation .
CONCLUSIONS	There is no obvious difference in outcome including disease-specific survival , late toxicity and quality of life in elderly patients , compared to a matched younger population .
CONCLUSIONS	A clinically meaningful local tumor progression following radiotherapy or hormonal ablation only is rare .
CONCLUSIONS	Local radiotherapy or , alternatively , hormonal ablation is recommended to preserve local progression-free survival in elderly patients except for very early stage of disease ( i.e. T1 G1-2 M0 ) .

###11873666
BACKGROUND	Acute pancreatitis ( AP ) is a common cause of admission to the emergency room .
BACKGROUND	Its etiopathogeny is poorly understood .
BACKGROUND	The pancreatic inflammatory response in this process is unclear .
BACKGROUND	The influence of the autonomic nervous system is a controversial issue .
OBJECTIVE	To demonstrate the effects of truncular vagotomy on AP due to duodenal distention in the South American opossum .
OBJECTIVE	PLACE OF APPLICATION : Department of experimental surgery ( Churruca-Visca Hospital ) INEUCI ( Neuroscience Institute , CONICET , UBA ) .
METHODS	Male and female South American opossum divided into : a control group ( 7 animals ) ; group A : truncular vagotomy and pyloroplasty seven days after the onset of AP ( 7 animals ) .
METHODS	Group B : truncular vagotomy and pyloroplasty 30 days after provoking AP ( 7 animals ) .
METHODS	Group C : truncular vagotomy and pyloroplasty 45 days after the onset of AP ( 7 animals ) .
METHODS	Acute pancreatitis was caused by duodenal distention of the second portion by inserting a Foley catheter through a gastrostomy .
CONCLUSIONS	The method of provoking AP is original .
CONCLUSIONS	The influence of autonomous nervous system is being underestimated in most of the literature available .

###18997085
OBJECTIVE	Macular telangiectasia ( MacTel ) type 2 typically exhibits sharply demarcated parafoveal scotomas .
OBJECTIVE	In an investigation of their significance for reading performance , reading acuity and speed were measured and correlated with parafoveal sensitivity and fixation stability .
METHODS	In this prospective controlled cross-sectional observational study , 49 eyes of 26 patients with MacTel type 2 were investigated .
METHODS	Twenty-four eyes of 14 age-matched normal subjects served as the control .
METHODS	Reading acuity and reading speed ( in words per minute [ wpm ] ) were assessed by Radner charts .
METHODS	Retinal sensitivity was measured using fundus controlled microperimetry ( MP1 ; Nidek Technologies ) .
METHODS	Fixation stability was quantified by the bivariate contour ellipse area ( BCEA ) .
METHODS	Multiple logistic regression analysis was used to delineate outcome predictors of reading acuity and speed .
RESULTS	Mean reading speed was considerably reduced in patients ( to 141 wpm ; control speed , 190 wpm ; P < 0.001 ) as was reading acuity ( patients , 20/63 ; control subjects , 20/32 ; P < 0.001 ) .
RESULTS	Mean best corrected visual acuity ( BCVA ) was reduced in most eyes ( patients , 20/50 ; control subjects , 20/20 ; P < 0.001 ) .
RESULTS	Mean BCEA was not reduced compared with that in the control subjects .
RESULTS	BCVA reduction predicted reading acuity loss ( P = 0.02 ) and a decrease in maximum reading speed ( P < 0.001 ) .
RESULTS	Parafoveal sensitivity loss resulted in decreased reading acuity ( P = 0.03 ) and reading speed reduction ( P < 0.001 ) .
CONCLUSIONS	These findings indicate that parafoveal sensitivity loss in MacTel type 2 is associated with loss of reading performance despite stable central fixation .
CONCLUSIONS	Reading performance appears to be a sensitive variable of functional impairment in MacTel type 2 and should therefore be considered an outcome measure in future interventional trials .

###11773176
OBJECTIVE	To evaluate whether preoperative chemotherapy ( PCT ) could improve survival in resectable stage I ( except T1N0 ) , II , and IIIA non-small-cell lung cancer ( NSCLC ) .
METHODS	A randomized trial compared PCT to primary surgery ( PRS ) .
METHODS	PCT consisted of two cycles of mitomycin ( 6 mg/m ( 2 ) , day 1 ) , ifosfamide ( 1.5 g/m ( 2 ) , days 1 to 3 ) and cisplatin ( 30 mg/m ( 2 ) , days 1 to 3 ) , and two additional postoperative cycles for responding patients .
METHODS	In both arms , patients with pT3 or pN2 disease received thoracic radiotherapy .
RESULTS	Three hundred fifty-five eligible patients were randomized .
RESULTS	Overall response to PCT was 64 % .
RESULTS	There were two preoperative toxic deaths .
RESULTS	Postoperative mortality was 6.7 % in the PCT arm and 4.5 % in the PRS arm ( P = .38 ) .
RESULTS	Median survival was 37 months ( 95 % confidence interval [ CI ] , 26.7 to 48.3 ) for PCT and 26.0 months ( 95 % CI , 19.8 to 33.6 ) for PRS ( P = .15 ) .
RESULTS	Survival differences between both arms increased from 3.8 % ( 95 % CI , 1.3 % to 25.1 % ) at 1 year to 8.6 % ( 95 % CI , 2.64 % to 24.4 % ) at 4 years .
RESULTS	A quantitative interaction between N status and treatment was observed , with benefit confined to N0 to N1 disease ( relative risk [ RR ] , 0.68 ; 95 % CI , 0.49 to 0.96 ; P = .027 ) .
RESULTS	After a nonsignificant excess of deaths during treatment , the effect of PCT was significantly favorable on survival ( RR , 0.74 ; 95 % CI , 0.56 to 0.99 ; P = .044 ) .
RESULTS	Disease-free survival time was significantly longer in the PCT arm ( P = .033 ) .
CONCLUSIONS	Although impressive differences in median , 3-year , and 4-year survival were observed , they were not statistically significant , except for stage I and II disease .

###24428912
BACKGROUND	Individuals with a personal or family history of cancer , can opt for genetic counseling and DNA-testing .
BACKGROUND	Approximately 25 % of these individuals experience clinically relevant levels of psychosocial distress , depression and/or anxiety after counseling .
BACKGROUND	These problems are frequently left undetected by genetic counselors .
BACKGROUND	The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems , the ` Psychosocial Aspects of Hereditary Cancer ( PAHC ) questionnaire ' together with the Distress Thermometer , in : ( 1 ) facilitating personalized counselor-counselee communication ; ( 2 ) increasing counselors ' awareness of their counselees ' psychosocial problems ; and ( 3 ) facilitating the management of psychosocial problems during and after genetic counseling .
METHODS	This multicenter , randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands .
METHODS	Participants will be randomized to either : ( 1 ) an intervention group that completes the PAHC questionnaire , the results of which are made available to the genetic counselor prior to the counseling session ; or ( 2 ) a control group that completes the PAHC questionnaire , but without feedback being given to the genetic counselor .
METHODS	The genetic counseling sessions will be audiotaped for content analysis .
METHODS	Additionally , study participants will be asked to complete questionnaires at baseline , three weeks after the initial counseling session , and four months after a telephone follow-up counseling session .
METHODS	The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study , as well as a checklist directly after each counseling session .
METHODS	The questionnaires/checklists of the study include items on communication during genetic counseling , counselor awareness of their clients ' psychosocial problems , the ( perceived ) need for professional psychosocial support , cancer worries , general distress , specific psychosocial problems , satisfaction with care received , and experience using the PAHC questionnaire .
CONCLUSIONS	This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication , increasing counselors ' awareness , and optimizing management of psychosocial problems in the cancer genetic counseling setting .
BACKGROUND	This study is registered at the Netherlands Trial Register ( NTR3205 ) and ClinicalTrials.gov ( NCT01562431 ) .

###9170463
OBJECTIVE	To evaluate the safety and clinical effectiveness of intravaginal misoprostol , a synthetic prostaglandin E1 analogue , for labor induction in gravidas with premature rupture of membranes ( PROM ) at term .
METHODS	One hundred forty-one pregnant women with term PROM were assigned randomly to one of two induction groups : 1 ) intravaginal misoprostol or 2 ) intravenous oxytocin by continuous infusion .
RESULTS	Seventy subjects were allocated to the misoprostol group and 71 to the oxytocin group .
RESULTS	The mean ( + / - standard deviation ) interval from induction to delivery was significantly shorter in the misoprostol group ( 416 + / - 276 compared with 539 + / - 372 minutes ; P = .04 ) .
RESULTS	In 85.7 % of patients in the misoprostol group , only one dose was required .
RESULTS	Intrapartum complication rates , mode of delivery , and neonatal or maternal adverse event rates were similar in the two treatment groups .
RESULTS	Uterine tachysystole occurred more frequently with misoprostol than with oxytocin ( 28.6 % compared with 14.0 % ; P < .04 ) .
CONCLUSIONS	Intravaginal administration of misoprostol induces labor safely and effectively in patients with PROM at term .

###21763393
OBJECTIVE	To study the feasibility , efficacy and safety of using the laryngeal mask airway ( LMA ) in neonatal resuscitation .
METHODS	In total , 369 neonates ( gestational age 34 weeks , expected birth weight 2.0 kg ) requiring positive pressure ventilation at birth were quasi-randomised to resuscitation by LMA ( 205 neonates ) or bag-mask ventilation ( 164 neonates ) .
RESULTS	( 1 ) Successful resuscitation rate was higher with the LMA compared with bag-mask ventilation ( P < 0.001 ) and the total ventilation time was shorter with the LMA than with bag-mask ventilation ( P < 0.001 ) .
RESULTS	Seven of nine neonates with an Apgar score of 2 or 3 at 1 min after birth were successfully resuscitated in the LMA group , while in the BMV group all six neonates with an Apgar score of 2 or 3 at 1 min required tracheal intubation and ventilation .
RESULTS	In neonates with an Apgar score of 4 or 5 at 1 min after birth , successful resuscitation rate with the LMA was higher than with bag-mask ventilation ( P < 0.01 ) .
RESULTS	( 2 ) Successful insertion rate of the LMA at the first attempt was 98.5 % and the insertion time was 7.8 s 2.2 s.
RESULTS	There were few adverse events ( vomiting and aspiration ) in the LMA group .
CONCLUSIONS	The LMA is safe , effective and easy to implement for the resuscitation of neonates with a gestational age of 34 or , more weeks .

###17854247
OBJECTIVE	Zonisamide and bupropion have been investigated for weight reduction in obese adults .
OBJECTIVE	We conducted a preliminary study comparing the effect on body weight of the combination of these 2 drugs versus zonisamide monotherapy .
METHODS	This was a 12-week , randomized , open-label , parallel-group comparison of 2 active interventions conducted from October 2003 to June 2004 .
METHODS	Eighteen obese women ( mean [ SE ] body mass index of 36.8 [ 1.2 ] kg/m ( 2 ) ) were randomly assigned to receive the combination of zonisamide and bupropion ( N = 9 ) or zonisamide alone ( N = 9 ) .
METHODS	All subjects were prescribed a balanced hypocaloric diet ( 500 kcal/day deficit ) and compliance was monitored with self-rated food diaries .
METHODS	Zonisamide therapy was started at 100 mg/day , with a gradual increase to 400 mg/day over 4 weeks for both groups .
METHODS	In addition , the group assigned to combination therapy received bupropion , which was started at 100 mg/day , with an increase to 200 mg/day after 2 weeks .
METHODS	Zonisamide was administered at night and bupropion in the morning .
METHODS	Body weight in kilograms was the primary outcome measure .
RESULTS	In an intent-to-treat analysis , carrying the last observation forward for all randomly assigned participants with at least 1 postbaseline assessment , the combination group lost more body weight than the zonisamide group ( mean [ SE ] = 7.2 [ 1.2 ] kg [ 7.5 % ] vs. 2.9 [ 0.7 ] kg [ 3.1 % ] ; F = 4.7 , df = 4,56 ; p = .003 ) during the 12-week period .
RESULTS	For the subset of 12 patients ( combination , N = 7 ; zonisamide , N = 5 ) that completed the full 12-week treatment , the mean ( SE ) weight loss was 8.1 ( 1.4 ) kg ( 8.5 % ) for the combination group versus 3.0 ( 0.9 ) kg ( 3.3 % ) for the zonisamide group ( F = 4.6 , df = 4,40 ; p = .004 ) .
RESULTS	Six subjects in the combination group and 2 in the zonisamide group lost at least 5 % of body weight .
CONCLUSIONS	In this short-term , open-label , preliminary trial , combination treatment of zonisamide and bupropion resulted in more weight loss than treatment with zonisamide alone .

###16292334
OBJECTIVE	The purpose of this investigation was to compare the effectiveness of dorsal penile nerve block and topical lidocaine-prilocaine anesthesia techniques for pain relief during circumcision .
METHODS	In total , 18 healthy term newborn males were divided based on anesthesia .
METHODS	The topical lidocaine-prilocaine group had six males undergoing circumcision and three males undergoing a sham procedure .
METHODS	The dorsal penile nerve block group had six males undergoing circumcision and three males undergoing a sham procedure .
METHODS	The procedures were videotaped and viewed by 90 noninvestigator reviewers who scored the infants ' pain using the Neonatal Infant Pain Scale and a numeric pain scale .
METHODS	Statistical analysis utilized a P-value of < 0.05 as significant .
RESULTS	The median Neonatal Infant Pain Scale and numeric pain scores were significantly lower in the dorsal penile nerve block group than in the topical lidocaine-prilocaine group or the sham group ( Neonatal Infant Pain Scale : 1.0 ( range 0-6 ) versus 6.0 ( range 2-6 ) versus 4.0 ( range 0-6 ) , P < 0.001 , respectively ; numeric pain scale : 2.0 ( range 0-10 ) versus 8.0 ( range 1-10 ) versus 4.0 ( range 0-10 ) , P < 0.001 , respectively ) .
RESULTS	In the sham group , procedures with the dorsal penile nerve block had significantly lower pain scores than those with topical lidocaine-prilocaine ( Neonatal Infant Pain Scale : 1.0 ( range 0-6 ) versus 5.0 ( range 2 - 6 ) , P < 0.001 ; numeric pain scale : 1.0 ( 0-8 ) versus 6.0 ( range 0-10 ) , P < 0.001 ) .
RESULTS	When reviewers were divided by medical background , gender or parental status , no differences in pain scores were observed .
CONCLUSIONS	The dorsal penile nerve block anesthesia technique for newborn male circumcision was significantly more effective for pain relief than topical lidocaine-prilocaine .

###16824835
BACKGROUND	Auscultation of the heart is a routine procedure .
BACKGROUND	It is not known whether auscultatory skills can be improved by teaching or with the use of an advanced stethoscope .
METHODS	This study was a randomized trial with a 2 x 2 factorial design .
METHODS	Seventy-two house officers were randomized to a simple or an advanced stethoscope and to a 4-hour course in auscultation or no course .
METHODS	The doctors auscultated 20 patients ' hearts and categorized findings as normal or as one or more of 5 categories of heart diseases .
METHODS	Patients were selected such that 16 had a known heart disease as well as a corresponding murmur and 4 had no heart disease or murmur .
METHODS	Auscultatory performance was assessed as concordance with echocardiographic findings and interobserver variation .
RESULTS	Doctors using the advanced stethoscope diagnosed 35 % of the patients correctly , as compared with doctors using the simple stethoscope who did 33 % of the patients ( P = .27 ) .
RESULTS	Similarly , 34 % of the patients were diagnosed correctly by doctors who had received teaching as compared with 33 % of those who were by doctors who had received no teaching ( P = .41 ) .
RESULTS	The kappa values were higher for doctors who had received teaching for aortic stenosis ( 0.43 vs 0.28 , P = .004 ) and ventricular septum defect ( 0.07 vs 0.01 , P = .003 ) .
RESULTS	There was no difference between groups for any other single murmur or for the detection of murmurs as such .
CONCLUSIONS	Heart auscultation findings were in poor accordance with echocardiographic findings and had high interobserver variation .
CONCLUSIONS	Neither outcome improved to any important extent with the subjects ' use of an advanced stethoscope or attending of a course in heart auscultation .

###19074684
BACKGROUND	The recovery rate of upper limb function after stroke is poor when compared with independent walking .
BACKGROUND	Therefore , effective methods are warranted for upper limb rehabilitation .
OBJECTIVE	The aim of this study was to investigate the effectiveness of functional electric stimulation ( FES ) with bilateral activities training on upper limb function .
METHODS	This study was a double-blinded randomized controlled trial .
METHODS	Twenty patients were recruited 6 months after the onset of stroke and completed 15 training sessions .
METHODS	Participants were randomly assigned to the FES group or to the control group .
METHODS	Each session consisted of stretching activities ( 10 minutes ) , FES with bilateral tasks ( 20 minutes ) , and occupational therapy treatment ( 60 minutes ) .
METHODS	The participants used a self-trigger mechanism , with an accelerometer as a motion detector , for generating an electric stimulation pattern that was synchronized with the bilateral upper limb activities during the training .
METHODS	The participants in the control group received the same duration of stretching and occupational therapy training except that they just received placebo stimulation with the bilateral tasks .
METHODS	The outcome measures included Functional Test for the Hemiplegic Upper Extremity ( FTHUE ) , Fugl-Meyer Assessment ( FMA ) , grip power , forward reaching distance , active range of motion of wrist extension , Functional Independence Measure , and Modified Ashworth Scale .
RESULTS	At baseline comparison , there was no significant difference in both groups .
RESULTS	After 15 training sessions , the FES group had significant improvement in FMA ( P = .039 ) , FTHUE ( P = .001 ) , and active range of motion of wrist extension ( P = .020 ) when compared with the control group .
CONCLUSIONS	Bilateral upper limb training with FES could be an effective method for upper limb rehabilitation of stroke patients after 15 training sessions .

###19560639
OBJECTIVE	The purpose of this study was to analyze the clinical outcome of arthroscopic anterior cruciate ligament ( ACL ) reconstruction with bone-patellar tendon-bone autograft versus allograft .
METHODS	Between May 2000 and June 2004 , 172 patients undergoing arthroscopic bone-patellar tendon-bone ACL reconstruction were prospectively randomized into autograft ( n = 86 ) or allograft ( n = 86 ) groups .
METHODS	The senior surgeon performed all operations using the same surgical technique .
METHODS	Each fixation was performed by means of an interference screw .
METHODS	Patients were evaluated preoperatively and postoperatively at follow-up .
METHODS	Of the patients , 156 ( 76 in the autograft group and 80 in the allograft group ) were available for full evaluation .
METHODS	Evaluations included a detailed history , physical examination , functional knee ligament testing , KT-2000 arthrometer testing ( MEDmetric , San Diego , CA ) , Harner 's vertical jump and Daniel 's 1-leg hop tests , Lysholm score , Tegner score , International Knee Documentation Committee standard evaluation form , Cincinnati knee score , and radiograph .
RESULTS	Demographic data were comparable between groups .
RESULTS	The mean follow-up was 5.6 years for both groups .
RESULTS	There were no statistically significant differences according to evaluations of outcome between the 2 groups except that patients in the allograft group had a shorter operation time and longer fever time postoperatively compared with the autograft group .
RESULTS	The postoperative infection rates were 0 % and 1.25 % for the autograft group and allograft group , respectively .
RESULTS	There was a significant difference ( P < .05 ) in the development of osteoarthritis between the operated knee in comparison to the contralateral knee according to radiographs .
RESULTS	However , no significant difference was found between the 2 groups at the final follow-up examination ( P > .05 ) .
CONCLUSIONS	Both groups of patients achieved almost the same satisfactory outcomes after a mean of 5.6 years of follow-up .
CONCLUSIONS	Allograft is a reasonable alternative to autograft for ACL reconstruction .
METHODS	Level II , prospective comparative study .

###10532982
OBJECTIVE	To evaluate the effect of interferon-alpha2B on mumps orchitis , often caused by postpubertal mumps and which can result in permanent testicular atrophy .
METHODS	The study included 21 patients with mumps orchitis , treated between May 1990 and June 1997 .
METHODS	Patients were randomly assigned into two groups : in group 1 , 13 patients received therapy with interferon-alpha2B ( 3 x 10 ( 6 ) IU per day ) and group 2 did not , acting as controls .
METHODS	All were evaluated by measurements of testis size , mumps virus titre , hormone level and semen analysis .
RESULTS	In group 1 , the patients ' symptoms resolved within 2-3 days and the volume of the testes returned to normal within 11 days ; there was no testicular atrophy in any patient during the follow-up .
RESULTS	However , asthenospermia continued to be detected in four patients ( unilateral in two , bilateral in two ) .
RESULTS	In group 2 , the patients ' symptoms resolved within 5-6 days and the volume of the testes returned to normal within 10 days ; testes atrophied in three patients ( unilateral in two , bilateral in one ) during the follow-up .
RESULTS	Asthenospermia continued in four patients ( unilateral in two , bilateral in two ) .
CONCLUSIONS	These results suggest that treatment with systemic interferon-alpha2B is effective in preventing testicular atrophy when combined with standard symptomatic treatment .

###21879261
BACKGROUND	Patients with esophageal carcinoma receiving postoperative chemotherapy showed superior disease-free survival than those receiving surgery alone in a Japan Clinical Oncology Group trial ( JCOG9204 ) .
BACKGROUND	The purpose of this study was to evaluate optimal perioperative timing-that is , before or after surgery-for providing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma .
METHODS	Eligible patients with clinical stage II or III , excluding T4 , squamous cell carcinoma were randomized to undergo surgery followed ( group 1 ) or preceded ( group 2 ) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil .
METHODS	The primary end point was progression-free survival .
RESULTS	We randomized 330 patients , with 166 assigned to group 1 and 164 to group 2 , between May 2000 and May 2006 .
RESULTS	The planned interim analysis was conducted after completion of patient accrual .
RESULTS	Progression-free survival did not reach the stopping boundary , but overall survival in group 2 was superior to that of group 1 ( P = 0.01 ) .
RESULTS	Therefore , the Data and Safety Monitoring Committee recommended early publication .
RESULTS	Updated analyses showed the 5-year overall survival to be 43 % in group 1 and 55 % in group 2 ( hazard ratio 0.73 , 95 % confidence interval 0.54-0 .99 , P = 0.04 ) , where the median follow-up of censored patients was 61.6 months .
RESULTS	Concerning operative morbidity , renal dysfunction after surgery in group 2 was slightly higher than in group 1 .
CONCLUSIONS	Preoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma .

###10553743
OBJECTIVE	Acute stress disorder permits an early identification of trauma survivors who are at risk of developing chronic posttraumatic stress disorder ( PTSD ) .
OBJECTIVE	This study aimed to prevent PTSD by an early provision of cognitive behavior therapy .
OBJECTIVE	Specifically , this study indexed the relative efficacy of prolonged exposure and anxiety management in the treatment of acute stress disorder .
METHODS	Forty-five civilian trauma survivors with acute stress disorder were given five sessions of 1 ) prolonged exposure ( N = 14 ) , 2 ) a combination of prolonged exposure and anxiety management ( N = 15 ) , or 3 ) supportive counseling ( N = 16 ) within 2 weeks of their trauma .
METHODS	Forty-one trauma survivors were assessed at the 6-month follow-up .
RESULTS	Fewer patients with prolonged exposure ( 14 % , N = 2 of 14 ) and prolonged exposure plus anxiety management ( 20 % , N = 3 of 15 ) than supportive counseling ( 56 % , N = 9 of 16 ) met the criteria for PTSD after treatment .
RESULTS	There were also fewer cases of PTSD in the prolonged exposure group ( 15 % , N = 2 of 13 ) and the prolonged exposure plus anxiety management group ( 23 % , N = 3 of 13 ) than in the supportive counseling group ( 67 % , N = 10 of 15 ) 6 months after the trauma .
RESULTS	Chronic PTSD in the supportive counseling condition was characterized by greater avoidance behaviors than in the prolonged exposure condition or the prolonged exposure plus anxiety management condition .
CONCLUSIONS	These findings suggest that PTSD can be effectively prevented with an early provision of cognitive behavior therapy and that prolonged exposure may be the most critical component in the treatment of acute stress disorder .

###19772451
BACKGROUND	Patients with type 2 diabetes often initiate insulin with once-daily basal insulin .
BACKGROUND	Over time , many patients intensify their insulin regimens in an attempt to attain and sustain glycemic targets .
BACKGROUND	This study compares three intensification approaches : changing insulin glargine to preprandial AIR inhaled insulin ( developed by Alkermes , Inc. [ Cambridge , MA ] and Eli Lilly and Company [ Indianapolis , IN ] ; AIR is a registered trademark of Alkermes , Inc. ) , intensifying glargine via validated titration algorithms ( IG ) , or adding AIR insulin while intensifying glargine ( AIR + IG ) .
METHODS	Five hundred sixty patients with hemoglobin A ( 1c ) ( A1C ) of 7.5-10 .5 % , on one or more antihyperglycemic medications , and on once-daily insulin glargine for > or = 4 months were randomly allocated to one of the three treatments lasting 52 weeks .
METHODS	The primary objective assessed between-group differences in A1C mean change from baseline to 24 weeks using last-observation-carried-forward ( LOCF ) in the intent-to-treat population .
RESULTS	At 24 weeks , A1C was reduced from a mean baseline of 8.5 % to 7.7 % , 7.9 % , and 7.5 % for the AIR , IG , and AIR + IG groups , respectively .
RESULTS	AIR produced 0.20 % greater A1C decrease than IG ( least-squares mean difference = -0.20 % ; 95 % confidence interval [ CI ] , -0.39 , -0.02 ) .
RESULTS	AIR + IG had a 0.35 % greater A1C decrease versus IG ( 95 % CI , -0.57 , -0.13 ) .
RESULTS	The -0.15 % difference between AIR + IG versus AIR was not significant ( P < 0.198 ) .
RESULTS	More hypoglycemia categorized as severe occurred with AIR alone versus IG alone at LOCF end points .
RESULTS	More nocturnal hypoglycemia occurred with IG alone versus AIR alone and AIR + IG .
CONCLUSIONS	Preprandial inhaled insulin provides an alternative for patients not optimized on insulin glargine alone .
CONCLUSIONS	Glycemic control , hypoglycemic risk , delivery preference , and regimen complexity must be considered when selecting insulin initiation and optimization regimens .

###11707559
OBJECTIVE	To evaluate the effectiveness of meal replacements ( MRs ) in weight loss interventions in premenopausal women .
METHODS	Overweight premenopausal women ( n = 113 ; body mass index : 25 to 35 kg/m ( 2 ) ; 30 to 50 years old ) were randomized into three interventions : group A , a dietitian-led intervention ; group B , a dietitian-led intervention incorporating MRs ; and group C , a clinical office-based intervention incorporating MRs. In year 1 , groups A and B attended 26 group sessions , whereas group C received the same educational materials during 26 10-minute office visits with a physician-nurse team .
METHODS	In year 2 , participants attended monthly group seminars and drop-in visits with a dietitian .
RESULTS	For the 74 subjects completing year 1 , weight loss in the office-based group C was as effective as the traditional dietitian-led group A ( 4.3 + / - 6.5 % vs. 4.1 + / - 6.4 % ) , while group B maintained a significantly greater weight loss ( 9.1 + / - 8.9 % ; p < 0.02 ; mean + / - SD ) .
RESULTS	For the 43 subjects completing year 2 , group B showed significant differences in the percentage of weight loss ( -8.5 + / - 7.0 % ) compared with group A ( -1.5 + / - 5.0 % ) and group C ( -3.0 + / - 7.0 % ; p < 0.001 ) .
CONCLUSIONS	Study results showed that a traditional weight loss intervention incorporating MRs was effective as a weight loss tool in the medical office practice and in the dietitian-led group setting .

###8993958
BACKGROUND	Cholinergic urticaria does not respond well to treatment with conventional antihistamines and is difficult to study because of its highly variable clinical expression which depends on the presence of eliciting factors .
OBJECTIVE	We have therefore designed a double-blind , crossover , placebo-controlled trial , with a 3-week treatment period using either 20 mg/day of cetirizine or placebo .
RESULTS	Presence of eliciting factors and symptoms were scored daily on a diary card by the patient , with a scale from 0 to 3 for erythema , wheals and pruritus .
RESULTS	Statistical analysis was done on 11 evaluable patients during the last 2 weeks of each treatment period ( to allow for 1 week of washout ) and only for days when eliciting factors were present .
RESULTS	Compared to placebo , cetirizine caused a statistically significant reduction of wheals ( p = 0.015 ) , erythema ( p = 0.033 ) , pruritus ( p = 0.006 ) and all symptoms ( p = 0.013 ) .
RESULTS	No adverse events were observed .
CONCLUSIONS	These data show a high efficacy of cetirizine at twice its normally recommended dose which may be related to the specific antiallergic effects of this newer-generation antihistamine .

###19520905
BACKGROUND	Screening for lung cancer with modern imaging technology may decrease lung cancer mortality , but encouraging results have only been obtained in uncontrolled studies .
OBJECTIVE	To explore the effect of screening with low-dose spiral computed tomography ( LDCT ) on lung cancer mortality .
OBJECTIVE	Secondary endpoints are incidence , stage at diagnosis , and resectability .
METHODS	Male subjects , aged 60 to 75 years , smokers of 20 or more pack-years , were randomized to screening with LDCT or control groups .
METHODS	All participants underwent a baseline , once-only chest X-ray and sputum cytology examination .
METHODS	Screening-arm subjects had LDCT upon accrual to be repeated every year for 4 years , whereas controls had a yearly medical examination only .
RESULTS	A total of 2,811 subjects were randomized and 2,472 were enrolled ( LDCT , 1,276 ; control , 1,196 ) .
RESULTS	After a median follow-up of 33 months , lung cancer was detected in 60 ( 4.7 % ) patients receiving LDCT and 34 ( 2.8 % ) control subjects ( P = 0.016 ) .
RESULTS	Resectability rates were similar in both groups .
RESULTS	More patients with stage I disease were detected by LDCT ( 54 vs. 34 % ; P = 0.06 ) and fewer cases were detected in the screening arm due to intercurrent symptoms .
RESULTS	However , the number of advanced lung cancer cases was the same as in the control arm .
RESULTS	Twenty patients in the LDCT group ( 1.6 % ) and 20 controls ( 1.7 % ) died of lung cancer , whereas 26 and 25 died of other causes , respectively .
CONCLUSIONS	The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated .

###24261687
BACKGROUND	Determining sample sizes for metabolomic experiments is important but due to the complexity of these experiments , there are currently no standard methods for sample size estimation in metabolomics .
BACKGROUND	Since pilot studies are rarely done in metabolomics , currently existing sample size estimation approaches which rely on pilot data can not be applied .
RESULTS	In this article , an analysis based approach called MetSizeR is developed to estimate sample size for metabolomic experiments even when experimental pilot data are not available .
RESULTS	The key motivation for MetSizeR is that it considers the type of analysis the researcher intends to use for data analysis when estimating sample size .
RESULTS	MetSizeR uses information about the data analysis technique and prior expert knowledge of the metabolomic experiment to simulate pilot data from a statistical model .
RESULTS	Permutation based techniques are then applied to the simulated pilot data to estimate the required sample size .
CONCLUSIONS	The MetSizeR methodology , and a publicly available software package which implements the approach , are illustrated through real metabolomic applications .
CONCLUSIONS	Sample size estimates , informed by the intended statistical analysis technique , and the associated uncertainty are provided .

###12477473
OBJECTIVE	The aim of this study was to evaluate the patterns of compliance and the frequency of adenomas and neoplasms in a Swedish population .
METHODS	In 1996 , 2000 men and women born in 1935 or 1936 were selected at random from the population registers of Uppsala and Malm/Lund .
METHODS	All subjects were invited by mail to participate .
METHODS	In a randomised study design , subjects were either called up by a nurse to schedule the appointment for sigmoidoscopy or instructed to call themselves .
METHODS	At sigmoidoscopy subjects with a cancer , an adenoma ( neoplastic polyp ) or more than three hyperplastic polyps were scheduled for a complete colonoscopy .
RESULTS	Thirty-nine percent ( 770/1988 ) of all the invited subjects had a sigmoidoscopy .
RESULTS	The participation differed between the two centres , 47 % at the Uppsala centre and 30 % at the Malm/Lund centre ( P < 0.01 ) .
RESULTS	There was no statistically significant difference between the two different invitation groups .
RESULTS	In all , 98 subjects ( 13 % ) were planned for colonoscopy .
RESULTS	Thirty-one ( 35 % ) of the subjects having a colonoscopy were women and 57 ( 65 % ) were men .
RESULTS	Fifty-five true adenomas were found in 46 subjects .
RESULTS	All together , six subjects had proximal adenomas .
RESULTS	Five adenocarcinomas were diagnosed , all within the reach of the sigmoidoscope .
CONCLUSIONS	The compliance was lower and the adenomas were fewer than expected .
CONCLUSIONS	To increase compliance it is necessary with rigorously controlled invitation routines .

###12650495
OBJECTIVE	The reported incidence of shoulder tip pain following laparoscopic surgery varies from 35 to 63 % .
OBJECTIVE	This study evaluated the analgesic efficacy of either performing a prophylactic suprascapular nerve block with bupivacaine or applying a piroxicam patch to the skin over both shoulders for the relief of shoulder tip pain after laparoscopy .
METHODS	Sixty healthy informed female patients were randomly assigned to one of three groups : ( a ) a control group ( n = 20 ) , no treatment ; ( b ) a suprascapular nerve block group ( n = 20 ) in which a bilateral suprascapular nerve block was performed before induction of anaesthesia with 5 mL 0.5 % bupivacaine with epinephrine ; and ( c ) a piroxicam patch group ( n = 20 ) in which a 48 mg piroxicam patch on the skin of each shoulder was applied before induction of anaesthesia .
METHODS	All patients received a total intravenous anaesthesia technique with propofol , fentanyl and vecuronium .
METHODS	Shoulder tip and wound pain were recorded on a visual analogue pain scale at five time intervals for 24 h after surgery .
RESULTS	A total of 80 % of patients in the control group , 75 % in the suprascapular nerve block group and 45 % in the piroxicam patch group complained of shoulder tip pain during the recording period ( P < 0.05 ) .
RESULTS	The scores for shoulder tip pain in the piroxicam patch group were significantly lower compared with the control group at 3 , 6 and 12 h , and compared with the suprascapular nerve block group at 6 and 12 h.
RESULTS	The need for analgesics was also significantly lower in the piroxicam patch group compared with the other two groups .
CONCLUSIONS	Prophylactic piroxicam patches are effective and safe for the relief of shoulder tip pain after laparoscopy .
CONCLUSIONS	Bilateral suprascapular nerve block is not effective in this setting .

###22375604
BACKGROUND	Ribavirin-related anemia is a serious side-effect of the pegylated interferon and ribavirin therapy used for hepatitis C , and may be cause for a reduction in ribavirin dose or even cessation of treatment .
BACKGROUND	The aim of this study was to evaluate the prophylactic effects of oral eicosapentaenoic acid ( EPA ) supplementation on ribavirin-induced hemolytic anemia in pediatric and young adult patients .
METHODS	Twelve chronic hepatitis C patients ranging in age from 3 to 21 years ( mean , 13.9 5.1 years ) who received pegylated interferon -2 b and ribavirin combination therapy were randomized to either the control group ( n = 6 ) or EPA group ( n = 6 ) .
METHODS	Blood samples were collected before , and at 4 , 8 , and 16 weeks after treatment to measure clinical laboratory parameters .
RESULTS	The reduction in hemoglobin levels of the EPA group was significantly ameliorated at 8 and 16 weeks when compared to the control group ( P < 0.05 ) .
RESULTS	There was no significant difference in plasma ribavirin concentrations between the two groups during the treatment .
RESULTS	However , one patient in the control group had a reduction in ribavirin dose .
CONCLUSIONS	EPA supplementation prevented ribavirin-induced hemolytic anemia during combination therapy with pegylated interferon -2 b and ribavirin in pediatric and young adult patients .

###16210705
BACKGROUND	Health benefits associated with diets rich in vegetables and fruit ( VF ) are often attributed to the antioxidant activity of their constituent phytochemicals .
BACKGROUND	However , in vivo evidence that VF actually reduce markers of oxidative stress is limited .
OBJECTIVE	An 8-wk dietary intervention was conducted to test the hypothesis that increased VF consumption decreases oxidative stress .
OBJECTIVE	Urinary excretion of 8-isoprostane F2alpha ( 8-iso-PGF2alpha ) was used as an index of whole-body lipid peroxidation .
METHODS	The diets evaluated had comparable amounts of all macronutrients but varied in their content of VF .
METHODS	After a 2-wk low-VF ( 3.0 servings/d ) run-in diet , 246 women were randomly assigned to receive either 3.6 ( low ) or 9.2 ( high ) servings VF/d .
METHODS	The low-VF group was switched to the high-VF diet during the final 2 wk of the study .
METHODS	Blood and first-void urine specimens were obtained at baseline and at 2-wk intervals thereafter .
RESULTS	The run-in diet reduced 8-iso-PGF2alpha concentrations by 33 % ( P < 0.0001 ) .
RESULTS	The excretion of 8-iso-PGF2alpha with the low-VF diet remained the same as that with the run-in diet , whereas urinary concentrations of 8-iso-PGF2alpha were further reduced ( P < 0.01 ) by the high-VF diet , either fed throughout the study or when the diet was switched from low to high VF ( P = 0.05 ) .
RESULTS	The greatest reductions in 8-iso-PGF2alpha were observed in subjects in the highest quartile of baseline concentrations of 8-iso-PGF2alpha .
CONCLUSIONS	A significant reduction in the excretion of 8-iso-PGF2alpha was induced by the run-in diet and the high-VF diet .
CONCLUSIONS	The degree of reduction was related to the subject 's baseline urinary concentration of 8-iso-PGF2alpha .

###21617456
BACKGROUND	Partial flap loss is caused by the incapability of the vascular pedicle to provide sufficient microvascular perfusion in distal segments of the flap in addition to the reperfusion injury that occurs in the whole flap after free tissue transfer .
BACKGROUND	In experimental studies , the amino acid arginine reduces reperfusion injury and improves microvascular perfusion .
BACKGROUND	The purpose of this clinical study was to explore the effect of arginine in free flap surgery .
METHODS	In this randomized , double blind , placebo-controlled trial , 20 patients with unilateral breast reconstruction using the free transverse rectus abdominis myocutaneous flap were included .
METHODS	Patient and flap data were recorded .
METHODS	Patients received a continuous intravenous infusion of arginine or the control amino acid alanine for 5 days .
METHODS	Microcirculation was recorded in the flap in a standardized fashion using laser Doppler flowmetry ( Perimed ) .
RESULTS	Zone IV microcirculatory blood flow postoperatively was higher in the arginine group than in the alanine control group ( p = 0.04 ) .
CONCLUSIONS	The authors ' study shows beneficial effects of intravenous therapy with arginine to improve microcirculation in the free transverse rectus abdominis myocutaneous flap .

###24001635
BACKGROUND	Patients experience reductions in quality of life ( QOL ) while receiving cancer treatment and several approaches have been proposed to address QOL issues .
BACKGROUND	In this project , the QOL differences between older adult ( age 65 + ) and younger adult ( age 18-64 ) advanced cancer patients in response to a multidisciplinary intervention designed to improve QOL were examined .
METHODS	This study was registered on ClinicalTrials.gov , NCT01360814 .
METHODS	Newly diagnosed advanced cancer patients undergoing radiation therapy were randomized to active QOL intervention or control groups .
METHODS	Those in the intervention group received six multidisciplinary 90-minute sessions designed to address the five major domains of QOL .
METHODS	Outcomes measured at baseline and weeks 4 , 27 , and 52 included QOL ( Linear Analogue Self-Assessment ( LASA ) , Functional Assessment of Cancer Therapy-General ( FACT-G ) ) and mood ( Profile of Mood States ( POMS ) ) .
METHODS	Kruskall-Wallis methodology was used to compare scores between older and younger adult patients randomized to the intervention .
RESULTS	Of 131 patients in the larger randomized controlled study , we report data on 54 evaluable patients ( 16 older adults and 38 younger adults ) randomized to the intervention .
RESULTS	Older adult patients reported better overall QOL ( LASA 74.4 vs. 62.9 , p = 0.040 ) , higher social well-being ( FACT-G 91.1 vs. 83.3 , p = 0.045 ) , and fewer problems with anger ( POMS anger-hostility 95.0 vs. 86.4 , p = 0.028 ) .
RESULTS	Long-term benefits for older patients were seen in the anger-hostility scale at week 27 ( 92.2 vs. 84.2 , p = 0.027 ) and week 52 ( 96.3 vs. 85.9 , p = 0.005 ) .
CONCLUSIONS	Older adult patients who received a multidisciplinary intervention to improve QOL while undergoing advanced cancer treatments benefited differently in some QOL domains , compared to younger adult patients .
CONCLUSIONS	Future studies can provide further insight on how to tailor QOL interventions for these age groups .

###18945220
BACKGROUND	Alcohol is a legal and accessible substance in Taiwan .
BACKGROUND	As excessive alcohol has been linked to health and social problems , it is necessary to develop a brief , rapid , and low-cost tool to help health care providers deal with persons in Taiwan whose alcohol consumption has become hazardous or harmful to their health .
METHODS	A randomized controlled clinical trial with 6 - and 12-month follow-ups was designed .
METHODS	Eighteen medical/surgical units at a medical center in northern Taiwan were randomly assigned to 2 groups : experimental ( n = 9 ) and control ( n = 9 ) .
METHODS	Inpatients on the units were enrolled if they met the following criteria : were older than 18 years , had no severe psychiatric illness , and were not pregnant .
METHODS	The experimental group ( n = 138 ) received the intervention , a 15-minute counseling visit in which nurses screened participants using the Alcohol Use Disorders Identification Test ( AUDIT ) , provided a health promotion booklet for adults , and individually discussed the booklet contents with patients based on their drinking level ( AUDIT score ) .
METHODS	The control group ( n = 137 ) received no treatment .
METHODS	Patterns of alcohol consumption were determined by AUDIT scores at baseline , 6 , and 12 months later .
RESULTS	Alcohol use disorders identification test scores decreased significantly in both groups at 6 months after the intervention , but did not differ significantly between the 2 groups .
RESULTS	However , 12 months after the brief alcohol intervention , experimental subjects ' AUDIT scores were significantly better than those of the control group .
CONCLUSIONS	Our brief alcohol intervention provided a 12-month benefit for problem drinkers in Taiwan .

###16162746
OBJECTIVE	To evaluate the effect of anticoagulant therapy on the survival of patients with idiopathic pulmonary fibrosis ( IPF ) .
METHODS	Prospective study .
METHODS	Five hospitals located in the Miyagi prefecture in Japan , including a university hospital , a Red Cross hospital , two public general hospitals , and a municipal hospital .
METHODS	Fifty-six patients with IPF ( mean age , 69.4 years ; range , 47 to 89 ) admitted to the hospitals from April 2001 to April 2004 .
METHODS	Patients were assigned to receive prednisolone alone or prednisolone plus anticoagulant therapy .
METHODS	The anticoagulants included oral warfarin in an outpatient setting and low-molecular-weight heparin for rehospitalized patients with severely progressive respiratory failure .
RESULTS	There was no difference in baseline characteristics , including age , gender , clinical condition , pulmonary function , and plasma d-dimer level between the non-anticoagulant group and the anticoagulant group .
RESULTS	The overall survival and hospitalization-free periods were assessed .
RESULTS	There was a significant difference between survival curves of the non-anticoagulant group and the anticoagulant group , with a 2.9 hazard ratio ( p = 0.04 , Cox regression model ) .
RESULTS	There was no significant difference in the probability of a hospitalization-free period between groups .
RESULTS	The major cause of clinical deterioration was acute exacerbation during follow-up in the present study .
RESULTS	Therefore , the mortality and plasma d-dimer levels in patients with an acute exacerbation were also assessed .
RESULTS	The mortality associated with acute exacerbations of IPF in the anticoagulant group was significantly reduced compared to that in the non-anticoagulant group ( 18 % vs 71 % , respectively ; p = 0.008 , Fisher Exact Test ) .
RESULTS	Furthermore , the plasma d-dimer levels in patients who died were significantly higher than those in survivors during acute exacerbation of IPF ( 3.3 + / - 2.3 microg/mL vs 0.9 + / - 0.7 microg/mL , p < 0.0001 ) .
RESULTS	Histologic analysis performed in three patients who died due to an exacerbation of IPF in the non-anticoagulant group demonstrated the features of usual interstitial pneumonia and acute lung injury .
CONCLUSIONS	Our data suggested that plasma d-dimer levels are associated with mortality in patients with an acute exacerbation of IPF , and that anticoagulant therapy has a beneficial effect on survival in patients with IPF .

###10954007
BACKGROUND	Additive hemodynamic effects of combined blockade of the renin-angiotensin system by an angiotensin I converting enzyme inhibitor and an angiotensin II antagonist have been observed in sodium-depleted normotensive volunteers and in patients with congestive heart failure .
OBJECTIVE	To investigate whether the same additive hemodynamic effects occur in patients with hypertension and to verify the safety of such an approach .
METHODS	Multicenter , randomized , double-blind , parallel-group , pilot study .
METHODS	177 patients with mild-to-moderate hypertension [ diastolic blood pressure ( DBP ) : 95-115 mmHg after a 4-week placebo run-in period ] were included in the study .
METHODS	Combination therapy consisting of 50 mg losartan daily and 10 mg enalapril daily was administered for 6 weeks .
METHODS	The effects of this therapeutic regimen was compared with similar groups of patients who received either 50 mg losartan daily or 10 mg enalapril daily .
METHODS	24-hour ambulatory mean DBP and clinic DBP measured at trough after 6 weeks of treatment .
RESULTS	24-hour ambulatory mean DBP did not significantly differ between treatment groups although the combination tended to lower BP more .
RESULTS	The combination therapy was more effective on clinic DBP measured at trough than was losartan by 3.2 mmHg [ confidence interval ( 95 % , CI ) 0.7-5 .7 mmHg , P = 0.012 ] , and more effective than enalapril by 4.0 mmHg ( 95 % CI , 1.5-6 .4 mmHg , P = 0.002 ) .
RESULTS	In a subgroup of 28 patients , higher plasma active renin and angiotensin I levels during blockade by the combination therapy were observed .
RESULTS	This finding confirmed that the combination of the two agents inhibited the renin-angiotensin system to a greater extent than did either agent alone .
CONCLUSIONS	A combination of 10 mg enalapril daily and 50 mg losartan daily safely induces a supplementary , although modest , fall in clinic DBP in patients with mild-to-moderate essential hypertension .

###19966539
OBJECTIVE	The French institute for study of geriatric infection risk ( ORIG ) has run a multiphase multicenter study ( VESTA ) to develop and implement active programs promoting healthcare worker ( HCW ) influenza vaccination .
OBJECTIVE	The present article reports results after implementation of the first active program .
METHODS	A cluster-randomized controlled trial was conducted from December 1 to December 15 , 2005 , and a total of 43 geriatric wards ( 3646 HCWs ) were randomly assigned to two clusters .
METHODS	The program cluster ( 24 wards ; 1918 HCWs ) received the active program whereas no action was taken in the control cluster ( 19 wards ; 1728 HCWs ) .
METHODS	The program was educational ; its objective was to convince HCWs to be vaccinated by giving them topdown scientific information and developing a sense of altruism .
METHODS	Data from 1201 HCWs ( 63 % ) from the program cluster and 1144 HCWs ( 66 % ) from the control cluster were collected .
RESULTS	The program failed to increase the HCW influenza vaccination rate ( program : 34 % ; control : 32 % ; p > 0.05 ) , but won the faithfulness of vaccinated HCWs ( 5 % vs 8 % HCWs quitted vaccination ; p < 0.05 ) .
CONCLUSIONS	Resistance to active influenza vaccination programs was found .
CONCLUSIONS	Future active programs will have to restore a climate of confidence between sources of knowledge and HCWs and promote `` self-protection '' in contrast with the protection of elderly people .

###14760933
BACKGROUND	Many papers have focused on the importance of granulocytes in the process of reperfusion and ischemia .
BACKGROUND	Most of the clinical studies measured several parameters of this process during and after coronary angiography , without taking into account the effect of the radiographic contrast media ( RCM ) used during this procedure .
METHODS	We performed a randomized patient study ( n = 37 ) to evaluate the effect of ionic and non-ionic RCM on granulocyte adhesion during coronary angiography .
METHODS	We also evaluated the influence of the ionicity and osmolarity of the different substances on granulocyte adhesion molecules in in vitro experiments .
RESULTS	The osmolarity of patient serum samples increased from 302 + / - 1 to 309 + / - 1 mOsm/kg ( p < 0.05 ) after infusion of RCM .
RESULTS	The CD11b expression in the samples of the non-ionic RCM treated group increased from 221 + / - 21 MFI to 377 + / - 30 MFI ( p < 0.05 ) measured as the absolute mean fluorescence intensity ( MFI ) , yet did not alter significantly in the ionic RCM group .
RESULTS	In contrast , the in vitro experiments showed a reduction of the CD11b expression from 360 + / - 70 MFI to 149 + / - 30 MFI ( p < 0.05 ) in the ionic RCM group .
CONCLUSIONS	The upregulation of adhesion molecules was significantly reduced in vivo with ionic RCM , while ionic substances caused opposite effects in vitro .
CONCLUSIONS	This effect should be taken into account when performing leukocyte functional analysis of samples taken during angiography .

###12560782
OBJECTIVE	To examine the clinical efficacy and safety of ertapenem , a novel beta-lactam agent with wide activity against common pathogens encountered in intraabdominal infection .
BACKGROUND	Ertapenem has a pharmacokinetic profile and antimicrobial spectrum that support the potential for use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic infections .
BACKGROUND	METHODS This prospective , randomized , controlled , and double-blind trial was conducted to compare the safety and efficacy of ertapenem with piperacillin/tazobactam as therapy following adequate surgical management of complicated intraabdominal infections .
RESULTS	Six hundred thirty-three patients were included in the modified intent-to-treat population , with 396 meeting all criteria for the evaluable population .
RESULTS	Patients with a wide range of infections were enrolled ; perforated or abscessed appendicitis was most common ( approximately 60 % in microbiologically evaluable population ) .
RESULTS	A prospective , expert panel review was conducted to assess the adequacy of surgical source control in patients who were failures as a component of evaluability .
RESULTS	For the modified intent-to-treat groups , 245 of 311 patients treated with ertapenem ( 79.3 % ) were cured , as were 232 of 304 ( 76.2 ) treated with piperacillin/tazobactam .
RESULTS	One hundred seventy-six of 203 microbiologically evaluable patients treated with ertapenem ( 86.7 % ) were cured , as were 157 of the 193 ( 81.2 % ) treated with piperacillin/tazobactam .
CONCLUSIONS	In this study , the efficacy of ertapenem 1 g once a day was equivalent to piperacillin/tazobactam 3.375 g every 6 hours in the treatment of a range of intraabdominal infections .
CONCLUSIONS	Ertapenem was generally well tolerated and had a similar safety and tolerability profile to piperacillin/tazobactam .
CONCLUSIONS	A formal process for review of adequacy of source control was found to be of benefit .
CONCLUSIONS	The results of this trial suggest that ertapenem may be a useful option that could eliminate the need for combination and/or multidosed antibiotic regimens for the empiric treatment of intraabdominal infections .

###21167330
BACKGROUND	Specific physical loading leads to enhanced bone development during childhood .
BACKGROUND	A general physical activity program mimicking a real-life situation was successful at increasing general physical health in children .
BACKGROUND	Yet , it is not clear whether it can equally increase bone mineral mass .
BACKGROUND	We performed a cluster-randomized controlled trial in children of both gender and different pubertal stages to determine whether a school-based physical activity ( PA ) program during one school-year influences bone mineral content ( BMC ) and density ( BMD ) , irrespective of gender .
METHODS	Twenty-eight 1st and 5th grade ( 6-7 and 11-12 year-old ) classes were cluster randomized to an intervention ( INT , 16 classes , n = 297 ) and control ( CON ; 12 classes , n = 205 ) group .
METHODS	The intervention consisted of a multi-component PA intervention including daily physical education with at least 10 min of jumping or strength training exercises of various intensities .
METHODS	Measurements included anthropometry , and BMC and BMD of total body , femoral neck , total hip and lumbar spine using dual-energy X-ray absorptiometry ( DXA ) .
METHODS	PA was assessed by accelerometers and Tanner stages by questionnaires .
METHODS	Analyses were performed by a regression model adjusted for gender , baseline height and weight , baseline PA , post-intervention pubertal stage , baseline BMC , and cluster .
RESULTS	275 ( 72 % ) of 380 children who initially agreed to have DXA measurements had also post-intervention DXA and PA data .
RESULTS	Mean age of prepubertal and pubertal children at baseline was 8.72.1 and 11.10.6 years , respectively .
RESULTS	Compared to CON , children in INT showed statistically significant increases in BMC of total body , femoral neck , and lumbar spine by 5.5 % , 5.4 % and 4.7 % ( all p < 0.05 ) , respectively , and BMD of total body and lumbar spine by 8.4 % and 7.3 % ( both p < 0.01 ) , respectively .
RESULTS	There was no gender * group , but a pubertal stage * group interaction consistently favoring prepubertal children .
CONCLUSIONS	A general school-based PA intervention can increase bone health in elementary school children of both genders , particularly before puberty .

###11837554
OBJECTIVE	To evaluate the effects of a high-fat meal on the systemic exposure of oral BMS-284756 .
METHODS	Open-label , randomized , two-way crossover study .
METHODS	Clinical research facility .
METHODS	Fourteen healthy individuals .
METHODS	Participants received two single 400-mg doses of BMS-284756 , separated by at least 1 week .
METHODS	One dose was given while participants were fasting , and one dose was given within 5 minutes of consumption of a high-fat meal .
RESULTS	Serial blood samples were collected , and plasma samples were analyzed for BMS-284756 using a validated liquid chromatography with tandem mass spectrometry detection method .
RESULTS	Maximum plasma concentration and area under the plasma concentration-time curve ( AUC ) after the high-fat meal were 19 % and 11 % lower , respectively , than those in the fasted state .
RESULTS	The 90 % confidence intervals for the ratios of means ( 0.71-0 .94 and 0.85-0 .93 , respectively ) satisfied predefined equivalence criteria .
RESULTS	Equivalence of the AUC values for BMS-284756 in fed and fasted individuals indicates that the presence of food should not affect the efficacy of this drug .
CONCLUSIONS	Single doses of BMS-284756 were safe and well tolerated and may be taken without regard to meals .

###18438876
OBJECTIVE	To evaluate the safety and efficacy of up to 8 years of etanercept treatment in patients with polyarticular-course juvenile rheumatoid arthritis ( JRA ) .
METHODS	Patients with JRA who previously participated in a randomized controlled trial ( RCT ) of etanercept were eligible to receive etanercept in a long-term open-label extension ( OLE ) trial .
METHODS	Safety end points included the incidences of serious adverse events ( SAEs ) , medically important infections ( MIIs ) , and death .
METHODS	Efficacy end points included the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 criteria for improvement .
RESULTS	Of the 69 patients originally enrolled in the RCT , 58 ( 84 % ) participated in the OLE , for a total of 318 patient-years of etanercept exposure .
RESULTS	A total of 42 of the 58 patients ( 72 % ) entered the fourth year of continuous etanercept treatment , and 26 patients ( 45 % ) entered the eighth year .
RESULTS	Sixteen patients ( 23 % of those entering the RCT ) reported 39 SAEs .
RESULTS	The overall rate of SAEs ( 0.12 per patient-year ) did not increase with long-term exposure to etanercept .
RESULTS	The rate of MIIs ( 0.03 per patient-year ) remained low ; 1 new MII was reported in patients with > or = 5 years of etanercept exposure .
RESULTS	No cases of tuberculosis , opportunistic infections , malignancies , lymphomas , lupus , demyelinating disorders , or deaths were reported .
RESULTS	An ACR Pedi 70 response or higher was achieved by 100 % of patients with 8 years of data ( 11 of 11 ) and by 61 % of patients according to the last observation carried forward data ( 28 of 46 ) .
CONCLUSIONS	These data suggest that the acceptable safety profile of etanercept therapy is maintained for up to 8 years in this population of JRA patients .
CONCLUSIONS	Improvements in the signs and symptoms of JRA were also maintained for up to 8 years .

###16206003
BACKGROUND	Pneumporeitoneum at 14 mmHg causes dangerous hemodynamic disturbances in some patients , leading to splanchnic ischemia .
BACKGROUND	Laparoscopic cholecystectomy ( LC ) using low-pressure pneumoperitoneum ( 7 mmHg ) minimizes adverse hemodynamic effects on hepatic portal blood flow and hepatic function .
BACKGROUND	This study evaluated the changes in liver function tests after high-pressure LC ( HPLC ; 14 mmHg ) and low-pressure LC ( LPLC ; 7 mmHg ) .
METHODS	For this study , 50 patients were randomly assigned to undergo either HPLC ( n = 25 ) or LPLC ( n = 25 ) Liver function tests including total bilirubin , gamma-glutamyltransferase ( GGT ) , alkaline phosphatase ( ALP ) , aspartate aminotransferase ( AST ) , and alanine aminotransferase ( ALT ) were obtained preoperatively , then 24 and 48 h postoperatively .
METHODS	All patients had normal values on the preoperative liver function tests .
METHODS	The anesthesiologic protocol was uniform .
RESULTS	The findings showed that ALT after 24 h ( LPLC : 1473.72 + / - 654.85 ; HPLC : 2233.74 + / - 1247.33 ; p = 0.0096 ) and 48 h ( LPLC : 1322.99 + / - 601.51 ; HPLC 2007.80 + / - 747.55 ; p = 0.0008 ) and AST after 24 h ( LPLC : 1189.96 + / - 404.79 i.j. ; HPLC : 1679.40 + / - 766.13 ; p = 0.0069 ) were increased in the patients who underwent HPLC .
RESULTS	The AST levels after 48 h were statistically unchanged from baseline in both groups .
RESULTS	Total bilirubin , ALP , and GGT levels remained unchanged from baseline in both groups , without a significant difference between the two groups .
CONCLUSIONS	Because LPLC minimizes adverse hemodynamic effects on hepatic function , a low-pressure pneumoperitoneum should be considered for patients with compromised liver function , particularly those undergoing prolonged laparoscopic surgery .

###18091270
OBJECTIVE	To evaluate diffusion tensor imaging ( DTI ) - based functional neuronavigation in surgery of cerebral gliomas with pyramidal tract ( PT ) involvement with respect to both perioperative assessment and follow-up outcome .
METHODS	A prospective , randomized controlled study was conducted between 2001 and 2005 .
METHODS	A consecutive series of 238 eligible patients with initial imaging diagnosis of cerebral gliomas involving PTs were randomized into study ( n = 118 ) and control ( n = 120 ) groups .
METHODS	The study cases underwent DTI and three-dimensional magnetic resonance imaging scans .
METHODS	The maps of fractional anisotropy were calculated for PT mapping .
METHODS	Both three-dimensional magnetic resonance imaging data sets and fractional anisotropy maps were integrated by rigid registration , after which the tumor and adjacent PT were segmented and reconstructed for presurgical planning and intraoperative guidance .
METHODS	The control cases were operated on using routine neuronavigation .
RESULTS	There was a trend for high-grade gliomas ( HGGs ) in the study group to be more likely to achieve gross total resection ( 74.4 versus 33.3 % , P < 0.001 ) .
RESULTS	There was no significant difference of low-grade gliomas resection between the two groups .
RESULTS	Postoperative motor deterioration occurred in 32.8 % of control cases , whereas it occurred in only 15.3 % of the study cases ( P < 0.001 ) .
RESULTS	The 6-month Karnofsky Performance Scale score of study cases was significantly higher than that of control cases ( 86 + / - 20 versus 74 + / - 28 overall , P < 0.001 ; 93 + / - 10 versus 86 + / - 17 for low-grade gliomas , P = 0.013 ; and 77 + / - 27 versus 53 + / - 32 for HGGs , P = 0.001 ) .
RESULTS	For 81 HGGs , the median survival of study cases was 21.2 months ( 95 % confidence interval , 14.1-28 .3 mo ) compared with 14.0 months ( 95 % confidence interval , 10.2-17 .8 mo ) of control cases ( P = 0.048 ) .
RESULTS	The estimated hazard ratio for the effect of DTI-based functional neuronavigation was 0.570 , representing a 43.0 % reduction in the risk of death .
CONCLUSIONS	DTI-based functional neuronavigation contributes to maximal safe resection of cerebral gliomas with PT involvement , thereby decreasing postoperative motor deficits for both HGGs and low-grade gliomas while increasing high-quality survival for HGGs .

###19817194
OBJECTIVE	To explore an exercise method for the prevention and treatment of the patients with shoulder and back fasciitis .
METHODS	From 2006.8 to 2008.3 , 120 patients with shoulder and back fasciitis were randomly divided into control group ( n = 60 , including 21 females and 39 males , the average age was ( 47.0 + / - 12.0 ) years , and the average course of disease was ( 14.1 + / - 12.0 ) months ) and treatment group ( n = 60 , including 19 females and 41 males , the average age was ( 43.7 + / - 9.9 ) years , and the average course of disease was ( 16.4 + / - 13.4 ) months ) .
METHODS	The patients in the control group received massage therapy and the ones in the treatment group were treated with massage therapy and horizontal bar exercise .
METHODS	After 3 weeks treatment , the curative effects of the patients in two groups were observed .
METHODS	All the patients were followed up for 6 to 26 months , the recurrence were observed .
RESULTS	After 3 weeks treatment , the scores of pain , sense of heaviness , strip sign , tenderness , shoulder and back function of the patients in two groups had significant differences compared with those before treatment ( all P < 0.01 ) .
RESULTS	After treatment , the scores of pain , sense of heaviness , strip sign , tenderness , shoulder and back function of the patients in the treatment group were lower than those in the control group ( P < 0.05 ) .
RESULTS	After 6 to 26 months following-up , the rate of recurrence in the treatment group was lower than that in the control group ( P < 0.01 ) .
CONCLUSIONS	Horizontal bar exercise is a simple , no expense and effective method in the prevention and treatment of shoulder and back fasciitis , which can improve the effect of the treatment and reduce the rate of recurrence .

###18544744
BACKGROUND	In the Raloxifene Use for The Heart trial , 10 101 postmenopausal women with coronary heart disease ( CHD ) or multiple CHD risk factors were randomly assigned to 60 mg/d raloxifene or to placebo and followed for a median of 5.6 years .
BACKGROUND	Raloxifene , a selective estrogen receptor modulator , was found to reduce the risk of invasive breast cancer and vertebral fractures but not the risk of cardiovascular events .
BACKGROUND	Here , we provide further details about breast cancer incidence by tumor characteristics , duration of treatment , and subgroup .
METHODS	Reported breast cancer was adjudicated by an independent committee based on medical records and pathology reports .
METHODS	The primary analyses used Cox proportional hazards models with time to first breast cancer as the outcome .
METHODS	Subgroup effects were analyzed using similar models with terms for treatment by subgroup .
METHODS	All statistical tests were two-sided .
RESULTS	As previously reported , raloxifene reduced the incidence of invasive breast cancer by 44 % ( hazard ratio [ HR ] = 0.56 ; 95 % confidence interval [ CI ] = 0.38 to 0.83 ; absolute risk reduction = 1.2 invasive breast cancers per 1000 women treated for 1 year ) .
RESULTS	The lower incidence of invasive breast cancer reflected a 55 % lower incidence of invasive estrogen receptor ( ER ) - positive tumors ( HR = 0.45 ; 95 % CI = 0.28 to 0.72 ) .
RESULTS	However , raloxifene treatment did not reduce the incidence of noninvasive breast cancer or of invasive ER-negative breast cancer .
RESULTS	The reduced incidence of invasive breast cancer was similar across subgroups , including those defined by age , body mass index , family history of breast cancer , prior use of postmenopausal hormones , and 5-year estimated risk of invasive breast cancer .
CONCLUSIONS	Raloxifene reduces risk of invasive ER-positive breast cancer regardless of a woman 's baseline breast cancer risk but does not reduce risk of noninvasive or ER-negative breast cancers .
CONCLUSIONS	These results confirm those of the Multiple Outcomes of Raloxifene Evaluation , a previous randomized trial among women with osteoporosis .

###16650414
OBJECTIVE	To investigate the biochemical relationship between follicular/oocyte maturity and follicular inhibins and activin levels .
METHODS	Prospective study .
METHODS	Research laboratory in university hospital .
METHODS	Thirty-five women undertook IVF/ICSI program .
METHODS	Individual follicular fluid aspirations , oocyte isolation , follicular fluid storage .
METHODS	Inhibin A , inhibin B , and activin A concentrations , oocyte retrieval , and fertility outcome .
RESULTS	Inhibin A , inhibin B , and activin A concentrations varied from 7.9 to 436 ng/mL , 9.7 to 786 ng/mL , and 1.7 to 267.9 ng/mL , respectively .
RESULTS	There was no change of inhibin A concentrations , whereas inhibin B and activin A concentrations dropped dramatically as the follicles enlarged .
RESULTS	Total follicular content of inhibin A and activin A increased , and inhibin B remained constant .
RESULTS	Both inhibin A and inhibin B levels were significantly higher in those follicles from which an oocyte could be recovered , but they did not differ with respect to subsequent oocyte fertilization .
CONCLUSIONS	Inhibin A is actively produced throughout follicular growth to retain a set concentration .
CONCLUSIONS	In contrast , inhibin B appears not to be actively produced , and the concentration drops as follicles enlarge .
CONCLUSIONS	Activin A concentrations also decrease , but there is some extra synthesis .
CONCLUSIONS	Higher levels of inhibin A and B are associated with oocyte presence but not with fertilization rates .

###10573494
OBJECTIVE	To assess the impact of cholesterol lowering on positive exercise stress tests in hypercholesterolaemic patients with normal coronary angiograms .
METHODS	43 non-diabetic patients aged 43-61 years , with total serum cholesterol concentrations of more than 7.75 mmol/l , positive exercise tests , and normal coronary angiograms , were started on the American Heart Association step 1 diet .
METHODS	After 12 weeks these patients were randomly assigned to treatment for another 16 weeks with the diet alone ( diet group , n = 20 ) or with the diet plus lovastatin or simvastatin ( statin group , n = 23 ) .
METHODS	After this 28 week run in period , statins were withdrawn and lipid profile tests and exercise tests were done and repeated 20 weeks later .
RESULTS	At week 28 , the statin group but not the diet group had significant reductions from baseline ( week 12 ) in plasma total cholesterol ( p < 0.0001 ) , low density lipoprotein ( p < 0.0001 ) , and triglyceride ( p < 0.0001 ) .
RESULTS	The number of patients with positive exercise tests decreased from 23 to three in the statin group and from 20 to 15 in the diet group ( p = 0.01 ) .
RESULTS	After the final 20 weeks without statins , lipid profiles returned to baseline levels in all 17 patients remaining in the statin group , and exercise tests were again positive in 15 of these patients .
CONCLUSIONS	In hypercholesterolaemic patients with normal coronary arteries , cholesterol lowering treatment reduces myocardial ischaemia , as shown by the beneficial effects on exercise testing .

###15076811
OBJECTIVE	The objective of this study was to test the effectiveness of a mail-delivered , tailored self-management intervention ( SMART ) and to compare it with the classic Arthritis Self-Management Program ( ASMP ) .
METHODS	We performed 2 randomized controlled trials : 1 ) a study of 1090 participants randomized to SMART or USUAL CARE , and 2 ) a study of 341 participants randomized to SMART or ASMP .
METHODS	Dependent variables included disability , pain , depression , role function , global severity , doctor visits , and self-efficacy .
METHODS	SMART interventions were provided in months 0-18 and not reinforced .
METHODS	Results were assessed at 1 , 2 , and 3 years using analyses of covariance ( ANCOVA ) .
RESULTS	Compared with USUAL CARE , SMART participants at 1 year had decreased disability , improved role function , and increased self-efficacy ( all P < 0.01 ) .
RESULTS	At 2 years , decreases in global severity , doctor visits , and increases in self-efficacy ( all P < 0.01 ) were noted .
RESULTS	At 3 years without reinforcement , no statistically significant effects remained .
RESULTS	Compared with ASMP , SMART at 1 year had greater decreases in disability ( P = 0.02 ) and increases in self-efficacy ( P = 0.01 ) .
RESULTS	There were no differences at 2 years .
RESULTS	At 3 years , role function ( P = 0.04 ) and doctor visit ( P = 0.03 ) were improved in ASMP as compared with SMART .
RESULTS	Improvements from baseline were seen for nearly all variables in both groups .
CONCLUSIONS	A mail-delivered arthritis self-management program , SMART , was similarly effective to the classic ASMP , with slightly better results in the first year and a slightly more rapid attenuation over the next 2 years .
CONCLUSIONS	Results suggest that both programs are effective , and that the addition of a mail-delivered program could improve accessibility to arthritis self-management treatment .

###20173364
OBJECTIVE	To evaluate the safety , tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Gurin ( BCG ) in the treatment of high-risk superficial bladder cancer .
METHODS	64 patients with high-risk superficial bladder cancer ( pT1 and/or G3 and/or CIS ) were assigned to interventions ( gemcitabine or BCG ) in a randomised controlled trial .
METHODS	All the patients were evaluated for recurrence and progression rates ( primary endpoint ) and safety and tolerability ( secondary endpoint ) .
RESULTS	The two groups were comparable in terms of baseline characteristics .
RESULTS	Tolerability was better for gemcitabine , whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5 % of cases .
RESULTS	At a mean follow-up of 44 months , the recurrence rate in patients treated with BCG was 28.1 % ; the recurrence rate in patients who received gemcitabine was 53.1 % ( p = 0.037 ) .
RESULTS	Time to recurrence was shorter in patients treated with BCG ( 25.6 vs. 39.4 months , p = 0.042 ) .
RESULTS	No patients developed disease progression .
CONCLUSIONS	Gemcitabine is significantly inferior to BCG , but given its favourable toxicity profile , it may be useful for patients intolerant to or otherwise unable to receive BCG .

###7596696
OBJECTIVE	Abnormal defecation dynamics often are present in children with chronic constipation and encopresis .
OBJECTIVE	Patients who learned normal defecation dynamics with biofeedback treatment had improved short-term outcome .
OBJECTIVE	The aim of our research was to evaluate if biofeedback treatment improved long-term outcome .
METHODS	One hundred twenty-nine children with constipation , encopresis , and abnormal defecation dynamics were treated conventionally ; 63 of them received additional biofeedback training directed towards teaching normal defecation dynamics .
RESULTS	At follow-up ( 4.1 + / - 1.5 years ) , 86 % of conventionally treated patients and 87 % of biofeedback-treated patients had improvement in encopresis ; 62 % of conventionally treated patients , 50 % of successful biofeedback-treated patients , and 23 % of unsuccessful biofeedback-treated patients had recovered from chronic constipation and encopresis .
RESULTS	Recovery rates were similar for conventionally treated patients and biofeedback-treated patients who learned normal defecation dynamics ( P > .2 ) but significantly lower for unsuccessful biofeedback-treated patients ( P < .02 ) .
RESULTS	Length of follow-up was significantly related to recovery ( P < .01 ) .
CONCLUSIONS	Learning normal defecation dynamics with biofeedback training did not increase long-term recovery rates in children with chronic constipation , encopresis , and abnormal defecation dynamics above those achieved with conventional treatment alone .

###15567810
BACKGROUND	Anterograde , but not retrograde , amnesia has been demonstrated following midazolam administration .
BACKGROUND	However , there have been no studies investigating whether or not immediate retrograde amnesia can be produced with midazolam .
METHODS	After ethics committee approval and consent , 40 adult patients undergoing surgery and general anaesthesia were randomly allocated to one of four groups : midazolam 2 mg , midazolam 5 mg , midazolam 10 mg or control ( normal saline ) .
METHODS	Measurements were made from 12 min prior to induction of anaesthesia , and the study drug was administered 8 min prior to induction of anaesthesia .
METHODS	Midazolam effects were measured using visual recognition of posters , recall of specific events , bispectral index ( BIS ) and sedation visual analogue score .
RESULTS	Recognition and recall rates were similar between groups up until the time of study drug administration , with no evidence of retrograde amnesia ( all P > 0.3 ) .
RESULTS	There was a dose-dependent deterioration in visual recall ( P = 0.002 ) , event recollection ( P < 0.001 ) , BIS ( P < 0.001 ) and sedation score ( P < 0.001 ) following i.v. midazolam when compared with control .
CONCLUSIONS	We found no evidence that i.v. midazolam 2-10 mg produces immediate retrograde amnesia .
CONCLUSIONS	Midazolam causes anterograde amnesia in a dose-responsive manner .

###11888741
BACKGROUND	Gastric intramucosal pH ( pHi ) , a surrogate marker of splanchnic oxygenation , falls following abdominal aortic aneurysm surgery .
OBJECTIVE	To investigate the effects of volume expansion with hydroxyethyl starch ( eloHAES ) on splanchnic perfusion compared to another colloid such as gelofusine .
METHODS	Twenty-two consecutive patients undergoing AAA repair were randomised to receive either eloHAES or gelofusine as plasma expanders .
METHODS	Tissue oxygenation was monitored ( 10 gelofusine and 12 eloHAES ) indirectly by measuring pHi using a nasogastric tonometer .
RESULTS	Compared to the eloHAES group , the fall in pHi was significantly greater in the gelofusine group at clamp release ( 7.29 vs 7.33 , P = 0.003 ) and at 4 h following clamp release ( 7.29 vs 7.33 , P = 0.03 ) .
RESULTS	There was a good inverse correlation between the lowest pHi and the peak serum interleukin-6 ( r ( s ) = -0.47 , P = 0.03 ) .
RESULTS	By multivariate analysis , the only factor that influenced the pHi was the type of colloid used ( F = 5.54 , P = 0.005 ) .
RESULTS	The eloHAES treated patients required significantly less colloid on the first postoperative day ( 3175 + / - 175 vs 4065 + / - 269 ml , P = 0.01 ) .
CONCLUSIONS	In patients undergoing abdominal aortic aneurysm repair , plasma expansion with eloHAES improves microvascular perfusion and splanchnic oxygenation .

###9825744
OBJECTIVE	To compare the safety and efficacy of methotrexate ( MTX ) and gold sodium thiomalate ( GSTM ) in patients with active early erosive rheumatoid arthritis ( RA ) during 3 yr .
METHODS	A total of 174 patients from two centres were randomly assigned to receive weekly i.m. injections of either 15 mg MTX or 50 mg GSTM for 1 yr in a double-blind fashion .
METHODS	Thereafter , the study was continued as an open prospective trial for an additional 2 yr with the same dose of MTX and half of the GSTM dose .
METHODS	Clinical and laboratory evaluations were carried out at baseline and at months 6 , 12 , 18 , 24 and 36 in all patients , including withdrawals .
RESULTS	An intention-to-treat analysis revealed inactivation [ ` clinical remission ' : no swollen/tender joints , erythrocyte sedimentation rate ( ESR ) of < 20 mm/h in males and < 30 mm in females , no corticosteroids within the last 4 weeks ] in 33.3 % of MTX patients and 37.9 % of GSTM patients .
RESULTS	The mean time to inactivation was insignificantly shorter with GSTM ( MTX : 12.1 months ; GSTM : 9.1 months ; P = 0.06 ) .
RESULTS	At least marked improvement ( > 50 % reduction of the number of swollen/tender joints and of the ESR ) was found in 78.2 % ( MTX ) and 87.4 % ( GSTM ) .
RESULTS	Withdrawal from the study due to toxicity was recorded in 16.1 % of MTX and 52.9 % of GSTM patients after a mean time of 30.6 and 6.1 months , respectively ( P = 0.0001 ) .
RESULTS	In MTX and GSTM non-completers , inactivation was recorded in 24.2 and 54.7 % of all patients .
RESULTS	Among completers ( 54 and 34 patients , respectively ) , significant improvement compared to baseline was noted in all seven clinical variables ( morning stiffness , overall joint pain , count of tender/swollen joints , Lansbury articular score , functional score and grip strength ) , ESR and C-reactive protein without significant intergroup differences .
RESULTS	The steroid-sparing effect appeared more pronounced with GSTM .
CONCLUSIONS	Over 36 months , treatment with MTX or GSTM induces inactivation ( ` clinical remission ' ) of early and erosive RA in about one-third and at least marked improvement in four-fifths of patients ( intention-to-treat analysis ) .
CONCLUSIONS	Patients withdrawn from MTX or GSTM due to toxicity develop a clinical remission from the disease ; this occurred more often with GSTM .
CONCLUSIONS	Tolerability is significantly better with MTX .

###25212696
BACKGROUND	Little research has examined whether alcohol reduction interventions improve antiretroviral therapy ( ART ) adherence and HIV treatment outcomes .
BACKGROUND	This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers .
BACKGROUND	Specific aims include adapting a blended Motivational Interviewing ( MI ) and Problem Solving Therapy ( PST ) intervention for use with HIV patients ; evaluating the efficacy of the intervention for reducing alcohol consumption ; and assessing counsellors ' and participants ' perceptions of the intervention .
METHODS	A randomised controlled trial will evaluate the intervention among ART patients in public hospital-based HIV clinics in Tshwane , South Africa .
METHODS	We will recruit patients who are HIV-positive , on ART for at least 3months , and classified as harmful/hazardous drinkers using the AUDIT-3 .
METHODS	Eligible patients will be randomly assigned to one of three conditions .
METHODS	Patients in the experimental group will receive the MI-PST intervention to reduce harmful/hazardous alcohol use .
METHODS	Patients in the equal-attention wellness intervention group will receive an intervention focused on addressing health risk behaviours .
METHODS	Patients in the control condition will receive treatment as usual .
METHODS	Participants will complete an interviewer-administered questionnaire at baseline and 3 , 6 and 12months post-randomisation to assess alcohol consumption , ART adherence , physical and mental health .
METHODS	We will also collect biological specimens to test for recent alcohol consumption , CD4 counts and HIV RNA viral loads .
METHODS	The primary outcome will be reduction in the volume of alcohol consumed .
METHODS	Secondary outcomes include reduction in harmful/hazardous use of alcohol , reduction in biological markers of drinking , increase in adherence rates , reductions in viral loads , and increases in CD4 T-cell counts .
METHODS	A process evaluation will ascertain counsellors ' and participants ' perceptions of the acceptability and effectiveness of the interventions .
CONCLUSIONS	We have obtained ethical approval and approval from the study sites and regional and provincial health departments .
CONCLUSIONS	The study has implications for clinicians , researchers and policy makers as it will provide efficacy data on how to reduce harmful/hazardous alcohol consumption among HIV patients and will shed light on whether reducing alcohol consumption impacts on HIV treatment adherence and other outcomes .
BACKGROUND	Pan African Clinical Trials Register Number : PACTR201405000815100 .

###11889308
OBJECTIVE	To determine the plasma concentrations of lipopolysaccharide , tumor necrosis factor-alpha , interleukin-1 beta , and interleukin-6 in a homogeneous group of septic patients and to evaluate the effect of antibiotic treatment , imipenem or ceftazidime , on the release of lipopolysaccharide and cytokines .
METHODS	Prospective , randomized study .
METHODS	Sixteen-bed multidisciplinary intensive care unit .
METHODS	Twenty-four septic patients with documented Gram-negative nosocomial pneumonia .
METHODS	Controls were 20 patients admitted without sepsis and 20 healthy volunteers .
METHODS	Septic patients were randomized between imipenem and ceftazidime .
METHODS	Blood samples were collected before ( 0 hrs ) and after ( 4 and 12 hrs ) antibiotic treatment .
METHODS	Concentrations of lipopolysaccharide were measured by using the limulus assay , and cytokine concentrations were measured by enzyme-linked immunosorbent assay .
METHODS	Statistical analyses were performed by Kruskal-Wallis test , Mann-Whitney U test , and Student 's t-test .
RESULTS	The mean age was 48.5 + / - 19.5 .
RESULTS	The mean Acute Physiology and Chronic Health Evaluation II score was 18.4 + / - 4.5 .
RESULTS	Overall mortality rate was 45.4 % .
RESULTS	All septic patients showed significant higher concentrations of lipopolysaccharide ( p < .001 ) , tumor necrosis factor-alpha ( p < .04 ) , and interleukin-6 ( p < .001 ) than the controls , but interleukin-1 beta was never detected .
RESULTS	We did not find statistically significant changes in lipopolysaccharide or cytokine plasma concentrations over time within any of the two arms of the study ( ceftazidime vs. imipenem ) .
RESULTS	There were no statistically significant differences in lipopolysaccharide and interleukin-6 plasma concentrations between the two antibiotic treatments .
RESULTS	Although tumor necrosis factor-alpha plasma concentrations were significantly higher in the group treated with ceftazidime compared with the group treated with imipenem at the baseline and 4 hrs later , these differences were not statistically significant after 12 hrs of initiation of both treatments .
CONCLUSIONS	Patients with Gram-negative nosocomial pneumonia have high plasma concentrations of lipopolysaccharide , interleukin-6 , and tumor necrosis factor-alpha , but the antibiotic therapy evaluated did not significantly modify these concentrations .

###10651430
OBJECTIVE	To assess the efficacy and safety of intravenous ondansetron ( 4 mg ) for the prevention of nausea and vomiting after middle ear surgery under local anesthesia .
METHODS	The study was conducted by Division of Otorhinolaryngology in Prince of Wales Hospital , which is a tertiary referral center and teaching hospital for The Chinese University of Hong Kong .
METHODS	A double-blind randomized controlled trial .
METHODS	Fifty-eight Chinese patients undergoing tympanoplasty under local anesthesia from July 1995 to June 1997 were recruited .
METHODS	The mean age of patients was 42.8 years ( range 18-71 years ) .
METHODS	Patients were randomly allocated to receive a single dose of intravenous ondansetron ( 4 mg ) ( n = 29 ) or placebo ( n = 29 ) immediately before surgery .
METHODS	Patients were assessed for severity and frequency of postoperative nausea and vomiting at the 1st , 2nd , 4th , 8th , and 24th hours after middle ear surgery .
RESULTS	Female patients showed a higher prevalence of postoperative nausea and vomiting .
RESULTS	Twenty-eight percent of the patients experienced postoperative nausea , of whom 14 % also experienced vomiting .
RESULTS	Although the ondansetron group demonstrated a lower prevalence of postoperative nausea and vomiting ( PONV ) ( 24 % nausea and 10 % vomiting ) than the placebo group ( 31 % nausea and 17 % vomiting ) , significant reduction in postoperative vomiting only occurred in the first postoperative hour ( p = 0.038 ) .
RESULTS	No complications or adverse side effects were found to be associated with the use of ondansetron .
CONCLUSIONS	Single-dose ondansetron ( 4 mg ) given intravenously preoperatively significantly reduces postoperative vomiting in patients after tympanoplasty under local anesthesia and causes no adverse effects .

###18588736
BACKGROUND	Congenital cytomegalovirus infection is the leading identified nongenetic cause of congenital sensorineural hearing loss .
BACKGROUND	Most of the infections are asymptomatic but may be detected from umbilical cord vein and/or newborn serum positivity for human cytomegalovirus immunoglobulin M , and from urine positivity ( on polymerase chain reaction ) for human cytomegalovirus deoxyribonucleic acid in the newborn period .
BACKGROUND	Children infected by cytomegalovirus may later develop sensorineural hearing loss .
BACKGROUND	In symptomatically infected infants , ganciclovir therapy administered in the neonatal period prevents hearing deterioration .
BACKGROUND	However , preventative therapy of asymptomatic congenital cytomegalovirus disease with ganciclovir is controversial , as side effects such as severe neutropenia may occur during treatment .
METHODS	The study population consisted of 23 asymptomatic children with congenital cytomegalovirus infection .
METHODS	Twelve children were treated just after diagnosis of cytomegalovirus infection in the newborn period , with ganciclovir 10 mg/kg bodyweight for 21 days .
METHODS	The other 11 children were observed without therapy .
METHODS	Over a four to 10 year follow-up period , we evaluated all the children 's hearing status using pure tone audiometry .
RESULTS	All 23 children had normal sensorineural hearing at one year follow up .
RESULTS	Five of the 23 children ( 21.7 per cent ) were lost to follow up over the four to 11 year follow-up period .
RESULTS	Of the remaining 18 children , sensorineural hearing loss occurred in two ( 11.1 per cent ) .
RESULTS	Neither child had been treated with ganciclovir in the newborn period .
RESULTS	An eight-year-old boy showed bilateral high frequency loss and a 10-year-old girl showed severe unilateral sensorineural hearing loss .
RESULTS	In the ganciclovir-treated group ( nine children ) , none showed sensorineural hearing loss .
RESULTS	During ganciclovir therapy , moderate neutropenia occurred as a side effect in two out of 12 ( 16.6 per cent ) treated children .
RESULTS	Speech and general development were normal in all children .
CONCLUSIONS	Asymptomatic congenital cytomegalovirus infection is likely to be a leading cause of sensorineural hearing loss in young children .
CONCLUSIONS	Intravenous ganciclovir therapy seems to offer a medical option to prevent subsequent sensorineural hearing loss .
CONCLUSIONS	Further studies including a greater number of children are needed .
CONCLUSIONS	Cytomegalovirus screening models are mandatory if medical therapy is to be implemented in time .

###17344605
OBJECTIVE	To observe the curative effect of different physical rehabilitation techniques on patients with lumbar disc herniation .
METHODS	Eighty-four patients were randomly divided into Group A , Group B and Group C. Group A were treated with the computerized pelvis traction and ultrashort wave , Group B were treated with the computerized pelvis traction only , while Groups C were treated with the computerized pelvis traction , the ultrashort wave and the traditional Chinese medicine iontophoresis .
METHODS	The outcome was measured with the Japanese Orthopaedics Association Score ( JOA score ) about lower back pain ( LBP ) .
RESULTS	Compared with before the treatment , the JOA score of all the 3 groups increase markedly after the treatment ( P < 0.001 ) .
RESULTS	Compared with group B , the JOA score of Groups A and Group C significantly increased ( P < 0.05 ) .
RESULTS	Compared with Group A , the JOA score in Group C significantly increased ( P < 0.05 ) .
CONCLUSIONS	The curative effect of comprehensive rehabilitation on lumbar disc herniation is better than that of the single rehabilitation .

###17531690
OBJECTIVE	To identify risk factors and describe the effects of antibiotic prophylaxis on the incidence of postoperative endophthalmitis after cataract surgery based on analysis of the findings of the European Society of Cataract & Refractive Surgeons ( ESCRS ) multicenter study .
METHODS	Twenty-four ophthalmology units in Austria , Belgium , Germany , Italy , Poland , Portugal , Spain , Turkey , and the United Kingdom .
METHODS	A prospective randomized partially masked multicenter cataract surgery study recruited 16 603 patients .
METHODS	The study was based on a 2 x 2 factorial design , with intracameral cefuroxime and topical perioperative levofloxacin factors resulting in 4 treatment groups .
METHODS	The comparison of case and non-case data was performed using multivariable logistic regression analyses .
METHODS	Odds ratios ( ORs ) associated with treatment effects and other risk factors were estimated .
RESULTS	Twenty-nine patients presented with endophthalmitis , of whom 20 were classified as having proven infective endophthalmitis .
RESULTS	The absence of an intracameral cefuroxime prophylactic regimen at 1 mg in 0.1 mL normal saline was associated with a 4.92-fold increase ( 95 % confidence interval [ CI ] , 1.87-12 .9 ) in the risk for total postoperative endophthalmitis .
RESULTS	In addition , the use of clear corneal incisions ( CCIs ) compared to scleral tunnels was associated with a 5.88-fold increase ( 95 % CI , 1.34-25 .9 ) in risk and the use of silicone intraocular lens ( IOL ) optic material compared to acrylic with a 3.13-fold increase ( 95 % CI , 1.47-6 .67 ) .
RESULTS	The presence of surgical complications increased the risk for total endophthalmitis 4.95-fold ( 95 % CI , 1.68-14 .6 ) , and more experienced surgeons were more likely to be associated with endophthalmitis cases .
RESULTS	When considering only proven infective endophthalmitis cases , the absence of cefuroxime and the use of silicone IOL optic material were significantly associated with an increased risk , and there was evidence that men were more predisposed to infection ( OR , 2.70 ; 95 % CI , 1.07-6 .8 ) .
CONCLUSIONS	Use of intracameral cefuroxime at the end of surgery reduced the occurrence of postoperative endophthalmitis .
CONCLUSIONS	Additional risk factors associated with endophthalmitis after cataract surgery included CCIs and the use of silicone IOLs .

###15904552
BACKGROUND	Due to worldwide migration to Western countries , physicians are increasingly encountering patients with different ethnic backgrounds .
BACKGROUND	Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency .
OBJECTIVE	To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients .
METHODS	A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level .
METHODS	General practice in Rotterdam .
METHODS	Thirty-eight Dutch GPs in the Rotterdam region , with at least 25 % of inhabitants of non-Western origin , and 2407 visiting patients were invited to participate in the study .
METHODS	A total of 986 consultations were finally included .
METHODS	The GPs were educated about cultural differences and trained in intercultural communication .
METHODS	Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way .
METHODS	The primary outcome measure was mutual understanding and the secondary outcomes were patient 's satisfaction and perceived quality of care .
METHODS	The intervention effect was assessed for all patients together , for the ` Western ' and ` non-Western ' patients , and for patients with different cultural backgrounds separately .
RESULTS	An intervention effect was seen 6 months after the intervention , as improvement in mutual understanding ( and some improvement in perceived quality of care ) in consultations with ` non-Western ' patients .
CONCLUSIONS	A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between ` Western ' and ` non-Western ' patients .

###18593536
BACKGROUND	Dermoscopy began in 1663 , and until 1971 was used to diagnose skin lesions .
OBJECTIVE	To measure the correlation between simple observation and dermoscopy to diagnose pigmented skin lesions .
METHODS	The study was conducted in Centro Mdico Nacional La Raza .
METHODS	Sixty-eight patients with pigmented skin lesions were included .
METHODS	Participants were randomly examined by two dermatologists blinded to the study .
METHODS	Both dermatologists did simple observations and dermoscopy .
METHODS	Every participant was diagnosed using both procedures and by both doctors .
METHODS	A skin biopsy was obtained for pathological study .
RESULTS	Kappa index of agreement to diagnose malignancy of the skin lesion between simple observation and histology was 0.69 ( 95 % CI 0.44 , 0.93 ) ; the dermoscopy/histology Kappa index was 0.73 ( 95 % CI 0.60 , 0.87 ) .
RESULTS	75 % of positive results were obtained by using dermoscopy , compared to 63.9 % obtained by simple observation ( p = 0.12 ) .
RESULTS	Simple observation and dermoscopy showed 94.44 % and 90.38 % sensitivity , specificity was 73.33 and 82.92 % and test accuracy was 84.84 and 87.09 % respectively .
CONCLUSIONS	Dermoscopy is a non-invasive technique with acceptable specificity and superior than simple observation to diagnose pigmented skin lesions .

###16210311
BACKGROUND	We tested the hypothesis that ease of insertion , oropharyngeal leak pressure , fibreoptic position , gastric insufflation , and the frequency of mucosal trauma differ between the ProSeal laryngeal mask airway ( PLMA ) and the classic laryngeal mask airway ( cLMA ) in anaesthetized children .
BACKGROUND	For the PLMA , we also assessed the ease of gastric tube placement via the PLMA drain tube and measure residual gastric volume .
METHODS	240 consecutive ASA I-III children aged 1-16 yr were randomized for airway management with the ProSeal or cLMA .
RESULTS	The time taken to provide an effective airway , the number of insertion attempts , fibreoptic position of the airway tube and frequency of mucosal trauma were similar , but oropharyngeal leak pressure was higher ( 33 vs 26 cm H ( 2 ) O , P < 0.0001 ) and gastric insufflation less common ( 0 vs 6 % , P < 0.01 ) for the PLMA .
RESULTS	Gastric tube insertion was successful at the first attempt in 106 of 120 , and at the second attempt in 14 of 120 .
RESULTS	The mean ( sd ; range ) value for residual gastric volume was 2.2 ( 5.9 ; 0-30 ) ml .
RESULTS	There were no differences in performance among sizes for the PLMA and the cLMA .
CONCLUSIONS	We conclude that ease of insertion , fibreoptic position , and frequency of mucosal trauma are similar for the PLMA and cLMA in children , but oropharyngeal leak pressure is higher and gastric insufflation less common for the PLMA .
CONCLUSIONS	Gastric tube insertion has a high success rate , provided the PLMA is correctly positioned .

###24587571
OBJECTIVE	To evaluate next-morning driving performance after middle-of-the-night use of zolpidem 3.5 mg in a buffered sublingual formulation ( ZST ) .
METHODS	Single-center , four-period , randomized , double-blind , placebo-controlled , crossover study .
METHODS	Maastricht University , The Netherlands .
METHODS	Forty healthy volunteers ( 20 females ) .
METHODS	Single dose of ZST administered in the middle of the night at 3 and 4 h before driving , zopiclone 7.5 mg at bedtime 9 h before driving , and placebo .
METHODS	Performance in a 100-km standardized highway driving test in normal traffic measuring standard deviation of lateral position ( SDLP ) - an index of weaving .
METHODS	Drug-placebo changes in SDLP > 2.5 cm were considered to reflect clinically relevant driving impairment .
RESULTS	For ZST , Max McNemar symmetry analyses showed that the proportion of drivers classified as impaired was increased 3 h after dosing ( P < 0.012 ) , but not 4 h after dosing .
RESULTS	Mean increases in SDLP from placebo , although statistically significant , were small ( 1.46 cm [ P < 0.0001 ] at 3 h and 0.83 cm [ P = 0.0174 ] at 4 h ) .
RESULTS	The morning after zopiclone , 45 % of the drivers were classified as impaired with a mean increase in SDLP of 2.46 cm ( P < 0.0001 ) .
RESULTS	There were no significant sex differences in effects of ZST and zopiclone .
CONCLUSIONS	Zolpidem 3.5 mg in a buffered sublingual formulation has a minimal risk of impairing driving performance in the morning 4 hours after middle-of-the night use .
CONCLUSIONS	When taken 3 hours before driving , the drug may have impairing effects so caution should be exercised if medication is taken other than as indicated .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01106859 ; Trial Name : Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet ; http://clinicaltrials.gov/ct2/show/NCT01106859 .

###21879200
BACKGROUND	Iloprost has been reported to reduce Raynaud ` s phenomenon ( RP ) and to inhibit progression of systemic sclerosis ( SSc ) .
OBJECTIVE	The aim of our study was to compare monthly iloprost infusions with placebo in patients treated long-term .
METHODS	Seventeen patients , six with RP and 11 with SSc on monthly treatment with iloprost , received either a 3-hour intravenous infusion of iloprost or an equal volume of placebo once per month for 4 months in a monocentric , randomized , placebo-controlled , double-blind study .
METHODS	Raynaud attacks as measured by diary entries , skin temperature , skin sclerosis , fist closure , mouth opening , and digital ulcers were recorded during the observation period .
RESULTS	Whereas mouth opening improved significantly ( p = 0.043 ) in the iloprost-treated group , RS improved in both patient groups .
RESULTS	However , no significant differences were found in the outcome measures .
CONCLUSIONS	Although iloprost influences the inflammatory cascade in SSc , no statistical differences were seen in our study , indicating that treatment strategies with iloprost should be modified .

###12610037
OBJECTIVE	This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction ( ED ) in men with diabetes .
METHODS	In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial , 452 patients with diabetes ( type 1 or type 2 ) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks .
METHODS	Efficacy responses were assessed by International Index of Erectile Function domain scores , rates of vaginal penetration and successful intercourse , and a global assessment question ( GAQ ) about erection improvement during the previous 4 weeks .
RESULTS	After 12 weeks of treatment , a dose-dependent ( P = 0.02 ) improvement in erections was noted for the GAQ , with 57 and 72 % of men taking 10 mg or 20 mg vardenafil , respectively , reporting improved erections , in contrast to 13 % after taking placebo ( P < 0.0001 ) .
RESULTS	For the erectile function domain , dose-dependent ( P = 0.03 ) final scores for the 10 - and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo ( P < 0.0001 ) .
RESULTS	Both vardenafil doses significantly enhanced the rates of successful penetration ( P < 0.0001 ) and successful intercourse ( P < 0.0001 ) compared with placebo .
RESULTS	Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity , at each level of plasma HbA ( 1c ) , and for type 1 and 2 diabetes .
RESULTS	Treatment-emergent adverse events were primarily mild to moderate headache ( < or = 13 % ) , flushing ( < or = 10 % ) , and rhinitis ( < or = 10 % ) .
CONCLUSIONS	Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED .

###11853894
BACKGROUND	The study was performed to examine the effects of giving patients with acute myocardial infarction an advice and relaxation audio tape within 24 h of admission to hospital .
METHODS	A prospective , two-group design was used with 243 subjects randomised to receive either the advice and relaxation tape or a music tape of their choice within 24 h of sustaining a myocardial infarction .
METHODS	Outcomes comprised anxiety , cardiac misconceptions , lifestyle change , attendance at a cardiac rehabilitation programme , and quality of life .
RESULTS	Although the advice and relaxation tape reduced the number of cardiac misconceptions this did not lead to any improvements in outcome , whilst in hospital or at 6 months .
RESULTS	Both tapes were equally appreciated by the patients , 98 % of whom said that they would recommend them to other patients .
CONCLUSIONS	An advice and relaxation tape reduces cardiac misconceptions but does not confer any other benefits over a music tape .

###15818684
OBJECTIVE	Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold .
OBJECTIVE	Other prominent symptoms include disordered sleep and fatigue .
OBJECTIVE	FMS affects an estimated 2 % of the population , predominantly women .
OBJECTIVE	This trial was designed to evaluate the efficacy and safety of pregabalin , a novel alpha ( 2 ) - delta ligand , for treatment of symptoms associated with FMS .
METHODS	This multicenter , double-blind , 8-week , randomized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS .
METHODS	The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group .
RESULTS	Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0-10 scale ) ( P < / = 0.001 ) , and significantly more patients in this group had > / = 50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) .
RESULTS	Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change .
RESULTS	Pregabalin at 450 mg/day improved several domains of health-related quality of life .
RESULTS	Dizziness and somnolence were the most frequent adverse events .
RESULTS	Rates of discontinuation due to adverse events were similar across all 4 treatment groups .
CONCLUSIONS	Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo .
CONCLUSIONS	Pregabalin was well tolerated and improved global measures and health-related quality of life .

###17593932
OBJECTIVE	To study the effect of sea buckthorn berries on the number and duration of common cold ( CC ) infections .
OBJECTIVE	As secondary objectives the effects on digestive and urinary tract infections ( DTI , UTI ) , and serum C-reactive protein ( CRP ) concentrations were also investigated .
METHODS	A total of 254 healthy volunteers were randomly assigned to receive sea buckthorn or placebo product during the study , which 233 of them completed .
RESULTS	There were no significant differences in the number or duration of CC or DTI between groups ( CC : relative risks ( sea buckthorn vs placebo ) for the number and duration were 1.15 ( 95 % CI 0.90-1 .48 ) and 1.05 ( 95 % CI 0.87-1 .27 ) , respectively ) .
RESULTS	In the sea buckthorn group , as compared to the placebo , the serum CRP concentrations decreased significantly ( difference in median change -0.059 mg/l , P = 0.039 ) .
RESULTS	The number of UTI was too small to draw solid conclusions , but the results indicate the subject merits further investigation .
CONCLUSIONS	Sea buckthorn berries did not prevent CC or DTI .
CONCLUSIONS	However , a reductive effect on CRP , a marker of inflammation , and a risk factor for cardiovascular diseases , was detected .

###22011432
BACKGROUND	Obesity is a state of chronic low-grade inflammation .
BACKGROUND	Chronic low-grade inflammation is associated with the pathophysiology of both type-2 diabetes and atherosclerosis .
BACKGROUND	Prevention or reduction of chronic low-grade inflammation may be advantageous in relation to obesity related co-morbidity .
BACKGROUND	In this study we investigated the acute effect of dietary protein sources on postprandial low-grade inflammatory markers after a high-fat meal in obese non-diabetic subjects .
METHODS	We conducted a randomized , acute clinical intervention study in a crossover design .
METHODS	We supplemented a fat rich mixed meal with one of four dietary proteins - cod protein , whey isolate , gluten or casein .
METHODS	11 obese non-diabetic subjects ( age : 40-68 , BMI : 30.3-42 .0 kg/m2 ) participated and blood samples were drawn in the 4 h postprandial period .
METHODS	Adiponectin was estimated by ELISA methods and cytokines were analyzed by multiplex assay .
RESULTS	MCP-1 and CCL5/RANTES displayed significant postprandial dynamics .
RESULTS	CCL5/RANTES initially increased after all meals , but overall CCL5/RANTES incremental area under the curve ( iAUC ) was significantly lower after the whey meal compared with the cod and casein meals ( P = 0.0053 ) .
RESULTS	MCP-1 was initially suppressed after all protein meals .
RESULTS	However , the iAUC was significantly higher after whey meal compared to the cod and gluten meals ( P = 0.04 ) .
CONCLUSIONS	We have demonstrated acute differential effects on postprandial low grade inflammation of four dietary proteins in obese non-diabetic subjects .
CONCLUSIONS	CCL5/RANTES initially increased after all meals but the smallest overall postprandial increase was observed after the whey meal .
CONCLUSIONS	MCP-1 was initially suppressed after all 4 protein meals and the whey meal caused the smallest overall postprandial suppression .
BACKGROUND	ClinicalTrials.gov ID : NCT00863564 .

###17980416
BACKGROUND	Exercise-induced bronchoconstriction occurs in a large proportion of children with asthma , limiting everyday activities important for their physical and social development .
OBJECTIVE	The purpose of this randomized , double-blind , placebo-controlled study was to compare the ability of different patterns of antiasthmatic treatment , recommended in childhood asthma , to protect patients from exercise-induced bronchoconstriction .
METHODS	Children 6 to 18 years of age with atopic asthma were randomized to a 4-week , placebo-controlled , double-blind trial .
METHODS	Patients were randomly allocated to receive daily 200 microg budesonide ( twice daily , 100 microg per dose ) + 9 microg formoterol ( twice daily , 4.5 microg per dose ; n = 20 ) ; 200 microg budesonide + 5 or 10 mg montelukast ( once daily at bedtime ; n = 20 ) ; 5 or 10 mg montelukast ( n = 20 ) ; 200 microg budesonide ( n = 20 ) ; or placebo ( n = 20 ) .
METHODS	A standardized treadmill exercise challenge was performed before and after treatment .
RESULTS	Exercise-induced bronchoconstriction , reflected by area under the curve for the FEV1 values from exercise over the 20-minute period and by maximum percent fall in FEV1 after exercise , was significantly diminished after 4 weeks in all active treatment groups , and compared with placebo .
RESULTS	Exercise-induced bronchoconstriction protection improved more significantly in the budesonide + montelukast and montelukast groups compared with other therapeutic options .
CONCLUSIONS	These data indicate differences in effects on exercise-induced bronchoconstriction between therapeutic options recommended in childhood asthma .
CONCLUSIONS	Control of childhood asthma with exercise-induced bronchoconstriction can be obtained by using regular controller treatment .

###19447262
OBJECTIVE	The purpose of this study is to identify the effects of the suboccipital muscle inhibition technique in patients with short hamstring syndrome by means of tests designed to evaluate the elasticity of the hamstring muscles and pressure algometry of myofascial trigger points .
METHODS	Randomized clinical trial ( pre and postintervention ) .
METHODS	The study population comprised young adult students following their studies at the Physiotherapy School at the University of Extremadura ( Spain ) and footballers from an Extremadura Football Club with short hamstring syndrome .
METHODS	The sample ( 70 subjects = 47 male and 23 female ) was randomly divided into a control group ( n = 34 ) and an intervention group ( n = 36 ) .
METHODS	Mean sample age was 23.40 + / - 3.82 years .
METHODS	The control group was subjected to a placebo technique , whereas the intervention group was subjected to the suboccipital muscle inhibition technique .
METHODS	Pre and postintervention evaluation was used for the assessment of hamstring elasticity , and pressure algometry was also used ( myofascial trigger points ) .
METHODS	Statistical analyses were performed using the SPSS 14.5 package ( SPSS Inc , Chicago , Ill ) , comparing the sample between groups ( Kolmorogov-Smirnov test , Student t test , 2-way analysis of variance [ ANOVA ] , the chi ( 2 ) test ) .
RESULTS	The distribution of the quantitative variables was normal , and the mean time doing physical activity per week was 2.82 + / - 4.03 hours .
RESULTS	Two-way ANOVA afforded statistically significant results for the finger-floor test , straight leg raise test-left , straight leg raise test-right , left popliteal angle test ( P values < .001 ) , and right popliteal angle test ( P = .005 ) .
RESULTS	For pressure algometry , only the right semimembranosus muscle afforded statistically significant differences ( P = .021 ) .
CONCLUSIONS	According to the finger-floor distance test , the straight leg raise test , and the popliteal angle test , the suboccipital muscle inhibition technique modified the elasticity of the hamstring muscles for this group of subjects .
CONCLUSIONS	The suboccipital muscle inhibition technique modifies the pressure algometry of the semimembranosus muscle but does not modify that of the semitendinosus muscle or biceps femoris .

###18566199
OBJECTIVE	Convective warming is routinely employed to maintain perioperative normothermia .
OBJECTIVE	However , due to differences in nozzle temperature and air flow of the power units , there are clinically relevant differences in heat transfer among convective warming systems .
OBJECTIVE	The purpose of this study was to evaluate the use of a quieter , convective warming system ( WarmAir , sound pressure level 49 dba , air flow 35 cfm ) .
OBJECTIVE	The WarmAir system was compared to the standard , higher air flow system ( Bair Hugger Model 750 , sound pressure level 55 dba , air flow 48 cfm ) with regards to temperature outcome .
METHODS	Patients undergoing general anesthesia for major abdominal and orthopedic surgery were randomized into one of two groups : WarmAir or Bair Hugger .
METHODS	Both groups received an upper body , convective blanket using coverage appropriate for the given surgical procedure .
METHODS	Convective warming , at the high setting , was started after prepping and draping , and distal esophageal or nasopharyngeal temperature was measured intraoperatively .
METHODS	Sublingual temperature was measured preoperatively and on admission to the postanesthesia care unit .
RESULTS	The WarmAir ( n = 89 ) and Bair Hugger ( n = 95 ) groups were similar with respect to age , gender , body mass index , ASA status , fluid balance , and duration of surgery .
RESULTS	There was no difference in temperature outcomes between groups .
RESULTS	In the WarmAir group , preoperative , lowest intraoperative , end of surgery , and postanesthesia care unit admission temperatures were ( means + / - SD ) ; 36.3 + / - 0.5 , 35.4 + / - 1.1 , 36.4 + / - 0.7 , and 36.4 + / - 0.6 degrees C , respectively .
RESULTS	Corresponding temperatures in the Bair Hugger group were ; 36.3 + / - 0.6 , 35.6 + / - 1.0 , 36.5 + / - 0.6 , and 36.4 + / - 0.5 degrees C , respectively .
CONCLUSIONS	Despite differences in heating characteristics , both convective warming systems were effective in maintaining perioperative normothermia in patients undergoing major abdominal and orthopedic surgery .
CONCLUSIONS	Therefore , choice of warming system is dependent on other factors such as ergonomics and cost .

###19074463
OBJECTIVE	( a ) To compare the efficacy of low-activity ( 2 GBq ; 54 mCi ) ( 131 ) I ablation using l-thyroxine withdrawal or rhTSH stimulation , and ( b ) to assess the influence of thyroid remnants volume on the ablation rate .
METHODS	Patients underwent neck ultrasound , ( 131 ) I neck scintigraphy and radioiodine uptake .
METHODS	Post-therapy whole body scan ( WBS ) was acquired after 4-6 days .
METHODS	Ablation was assessed after 6-12 months by WBS , Tg and TgAb following l-thyroxine withdrawal .
METHODS	Group A : preparation by L-T ( 4 ) withdrawal ( 37 days ) ; 21 patients received ( 131 ) I ( 2.02 + / -0.22 GBq ; 54.6 + / -5.9 mCi ) and on the day of treatment , TSH , Tg , TgAb were measured ; Group B : stimulation by rhTSH ; 21 patients received ( 131 ) I ( 1.97 + / -0.18 GBq ; 53.2 + / -4.9 mCi ) 24 h after the second injection of rhTSH ( 0.9 mg ) and TSH , Tg and TgAb were measured after 2 days .
RESULTS	At follow-up , 90.0 % of patients from group A and 85.0 % of patients from group B had Tg levels < 1 ng/ml ; no uptake was observed in 95.2 % and in 90.5 % of patients from group A or B respectively , with no statistical differences for both ablation criteria .
RESULTS	Before ( 131 ) I treatment , small thyroid remnants ( < 1 ml ) were detected by US in < 25 % of all patients .
CONCLUSIONS	The use of rhTSH for the preparation of low-risk patients to ablation therapy with low activities of ( 131 ) I ( 2 GBq ; 54 mCi ) is safe and effective and avoids hypothyroidism .
CONCLUSIONS	The presence of thyroid remnants smaller than 1 ml at US evaluation had no effect on the ablation rate .

###17366797
OBJECTIVE	To compare the treatment results between radical surgery and late course accelerated hyperfractionated radiotherapy ( LCAHFR ) for patients with resectable esophageal cancer in the chest .
METHODS	From June 1998 to September 2002 , 269 patients with resectable esophageal cancer in the chest were randomized into two groups : 135 in surgery group and 134 in radiotherapy .
METHODS	The surgery group received esophagectomy including resection of the lesion and 5 cm margin at both ends from the lesion as well as surrounding lymph nodes > or = 5 mm and fatty tissue .
METHODS	In the radiotherapy group : irradiation field for the lesion in the upper esophageal cancer included the gross lesion , bilateral supraclavicular nodes and 4 cm of normal esophagus from lower margin of the gross disease ; for the esophageal cancer at the middle segment , it included the gross disease with 4 cm normal esophagus from both ends of the lesion ; for the lesion in the lower esophageal cancer , it included 4 cm of normal esophagus and the gross lesion as well as the draining gastric lymph nodes .
METHODS	The width of the irradiation field was 5-6 cm .
METHODS	The 90 % isodose volume was covered by the entire CTV with 3-5 beams , in a conventionally fractionated RT at 1.8-2 .0 Gy/d for the first two thirds of treatment course to a dose of about 50-50 .4 Gy followed by LCAHFR using reduced fields ( 2 cm extended margin at both ends of the lesion ) , twice daily at 1.5 Gy per fraction ( with aminimal interval of 6 h between fractions ) to a dose of 18-21 Gy .
METHODS	The total dose whole radiotherapy was 68.4-71 .0 Gy .
RESULTS	The 1 - , 3 - and 5-year overall survival rate was 93.3 % , 61.5 % and 36.9 % in the surgery group versus 88.6 % , 56.2 % and 34.7 % in the radiotherapy group without statistical difference between the two groups .
RESULTS	The 1 - , 3 - and 5-year progression free survival rate was 75.9 % , 43.7 % and 23.1 % in the surgery group and 73.3 % , 39.7 % and 20.6 % , respectively , in the radiotherapy group without statistical difference between the two groups either .
CONCLUSIONS	The results treated by late course accelerated hyperfractionated conformal radiotherapy alone may be comparable to that by radical surgery for patient with resectable esophageal cancer in the chest .

###12522833
OBJECTIVE	To compare scales measuring exercise-induced changes in mood .
METHODS	Mood changes in a randomized , 23-week controlled trial of exercise were assessed using the Beck Depression Inventory ( BDI ) , Center for Epidemiologic Studies Depression Scale ( CES-D ) , State Trait Anxiety Inventory ( STAI ) , Fibromyalgia Impact Questionnaire , and the Mental Health Inventory ( MHI ) .
METHODS	Effect sizes and t-tests were computed on 23-week change scores .
METHODS	Scales were deemed to be confounded if items addressed sleep disturbances , fatigue , or effort ( symptoms of both mood disturbances and fibromyalgia ) .
RESULTS	Efficacy ( 15 exercise subjects ) and intent-to-treat analyses ( 27 exercise subjects ) generated medium effects for BDI ( total , cognitive ) , MHI depression ( efficacy only ) , and CES-D ( intent-to-treat only ) scales .
RESULTS	BDI ( total , cognitive ) , MHI ( depression , positive affect , total [ MHI-5 ] ) , and STAI scales distinguished exercise from control subjects at 23 weeks in all analyses .
RESULTS	BDI somatic and CES-D scales were deemed to be confounded .
CONCLUSIONS	We recommend the BDI cognitive , STAI , and MHI-5 scales to measure depression , anxiety , and general mood , respectively , in patients with fibromyalgia .

###24678896
BACKGROUND	Colorectal cancer ( CRC ) is the second most prevalent type of cancer in Europe .
BACKGROUND	A single flexible sigmoidoscopy ( FS ) screening at around the age of 60 years prevents about one-third of CRC cases .
BACKGROUND	However , FS screens only the distal colon , and thus mortality from proximal CRC is unaffected .
BACKGROUND	Computed tomography colonography ( CTC ) is a highly accurate examination that allows assessment of the entire colon .
BACKGROUND	However , the benefit of CTC testing as a CRC screening test is uncertain .
BACKGROUND	We designed a randomized trial to compare participation rate , detection rates , and costs between CTC ( with computer-aided detection ) and FS as primary tests for population-based screening .
METHODS	An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years , living in the Piedmont region and the Verona district of Italy .
METHODS	Individuals with a history of CRC , adenomas , inflammatory bowel disease , or recent colonoscopy , or with two first-degree relatives with CRC will be excluded from the study by their general practitioners .
METHODS	Individuals responding positively to the invitation letter will be then randomized to the intervention group ( CTC ) or control group ( FS ) , and scheduled for the screening procedure .
METHODS	The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests .
METHODS	Secondary outcomes are cost-effectiveness analysis , referral rates for colonoscopy induced by CTC versus FS , and the expected and perceived burden of the procedures .
METHODS	To compare participation rates for CTC versus FS , 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS .
METHODS	In the CTC arm , non-responders will be offered fecal occult blood test ( FOBT ) as alternative screening test , while in the FS arm , non-responders will receive an invitation letter to undergo screening with either FOBT or CTC .
METHODS	Data on reasons for participation and non-participation will also be collected .
CONCLUSIONS	This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS .
CONCLUSIONS	The trial will also evaluate the role of computer-aided detection in a screening setting .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01739608 .

###14563591
OBJECTIVE	This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy ( CRT ) when combined with an implantable cardioverter defibrillator ( ICD ) .
BACKGROUND	Long-term outcome of CRT was measured in patients with symptomatic heart failure ( HF ) , intraventricular conduction delay , and malignant ventricular tachyarrhythmias ( ventricular tachycardia/ventricular fibrillation [ VT/VF ] ) requiring therapy from an ICD .
METHODS	Patients ( n = 490 ) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT ( n = 245 ) or control ( no CRT , n = 245 ) for up to six months .
METHODS	The primary end point was progression of HF , defined as all-cause mortality , hospitalization for HF , and VT/VF requiring device intervention .
METHODS	Secondary end points included peak oxygen consumption ( VO ( 2 ) ) , 6-min walk ( 6 MW ) , New York Heart Association ( NYHA ) class , quality of life ( QOL ) , and echocardiographic analysis .
RESULTS	A 15 % reduction in HF progression was observed , but this was statistically insignificant ( p = 0.35 ) .
RESULTS	The CRT , however , significantly improved peak VO ( 2 ) ( 0.8 ml/kg/min vs. 0.0 ml/kg/min , p = 0.030 ) and 6 MW ( 35 m vs. 15 m , p = 0.043 ) .
RESULTS	Changes in NYHA class ( p = 0.10 ) and QOL ( p = 0.40 ) were not statistically significant .
RESULTS	The CRT demonstrated significant reductions in ventricular dimensions ( left ventricular internal diameter in diastole = -3.4 mm vs. -0.3 mm , p < 0.001 and left ventricular internal diameter in systole = -4.0 mm vs. -0.7 mm , p < 0.001 ) and improvement in left ventricular ejection fraction ( 5.1 % vs. 2.8 % , p = 0.020 ) .
RESULTS	A subgroup of patients with advanced HF ( NYHA class III/IV ) consistently demonstrated improvement across all functional status end points .
CONCLUSIONS	The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay .

###9768403
OBJECTIVE	To compare manual phacofracture and phacoemulsification techniques .
METHODS	Dr. Rajendra Prasad Centre for Ophthalmic Sciences , New Delhi , India .
METHODS	This prospective , randomized study comprised 60 cases of age-related cataract randomly divided into 2 groups : 30 eyes had phacoemulsification and 30 , manual phacofracture using a trisection technique .
METHODS	Postoperative evaluation was at 1 day , 1 and 6 weeks , and 3 months .
METHODS	The parameters evaluated were amounts of viscoelastic material and irrigating fluid used , the time required to manage the nucleus , postoperative best corrected visual acuity , endothelial cell loss , and complications .
RESULTS	Mean viscoelastic material used intraoperatively ( 3.69 mL + / - 0.81 [ SD ] versus 1.76 + / - 0.54 mL ) and the time required to manage the nucleus ( 7.78 + / - 2.07 minutes versus 2.53 + / - 1.18 minutes ) were significantly greater in the phacofracture than in the phacoemulsification group , respectively .
RESULTS	Best corrected visual acuity was significantly better in the phacoemulsification group on the first postoperative day ; 64 % had a visual acuity of 6/9 or better versus 37 % in the phacofracture group .
RESULTS	Endothelial cell loss at 3 months was 17.66 + / - 3.65 % in the phacofracture group and 12.03 + / - 3.06 % in the phacoemulsification group and central corneal edema persisting for more than 1 week , 7 and 0 cases , respectively .
RESULTS	The differences between groups were statistically significant .
CONCLUSIONS	More experience in and further modification of the manual phacofracture technique are required before it can be recommended as a safe alternative to phacoemulsification .

###18815508
BACKGROUND	Preliminary research with the Categorization Program ( CP ) indicated that this therapeutic modality is beneficial in improving cognitive abilities in survivors of moderate-to-severe traumatic brain injury ( TBI ) .
BACKGROUND	This study provides additional evidence for the use of the CP in postacute TBI cognitive rehabilitation .
METHODS	Twenty-one participants in the experimental group received the CP training , and 14 participants in the control group received the conventional treatment used at their rehabilitation center .
METHODS	Following neuropsychological testing , participants began their therapy program .
RESULTS	There was no significant difference in the baseline performance of the 2 TBI groups on any of the measures .
RESULTS	CP-dependent measures correlated significantly with several neuropsychological tests .
RESULTS	Both groups improved in their neuropsychological test performance and on functional outcomes tests .
RESULTS	However , subjects in the experimental group improved on more tests than participants in the control group .
RESULTS	Posttest performance of subjects in the TBI control group was significantly lower on the CP Test 1 and CP Test 2 as compared with the experimental group .
RESULTS	Furthermore , the performance of participants in the CP group improved across the 3 probe tasks demonstrating generalizability to new tasks ; the performance of participants in the control group did not improve .
CONCLUSIONS	The CP is an effective therapy method to reduce categorization impairment and improve cognitive performance of survivors of TBI who are enrolled in postacute rehabilitation .
CONCLUSIONS	This study contributes to the growing body of evidence supporting cognitive rehabilitation efforts after TBI .

###16983477
BACKGROUND	The short-term clinical outcomes from a multicenter prospective randomized trial of laparoscopic Nissen versus anterior 90 degrees partial fundoplication have been reported previously .
BACKGROUND	These demonstrated a high level of satisfaction with the overall outcome following anterior 90 degrees fundoplication .
BACKGROUND	However , the results of postoperative objective tests and specific clinical symptoms are not always consistent with an individual patient 's functional status and general well being following surgery , and quality of life ( QOL ) is also an important outcome to consider following surgery for reflux .
BACKGROUND	Hence , QOL information was collected in this trial to investigate the hypothesis : improvements in QOL following laparoscopic antireflux surgery are greater after anterior 90 degrees partial fundoplication than after Nissen fundoplication .
METHODS	Patients undergoing a laparoscopic fundoplication for gastro-esophageal reflux at one of nine university teaching hospitals in six major cities in Australia and New Zealand were randomized to undergo either laparoscopic Nissen or anterior 90 degrees partial fundoplication .
METHODS	Quality of life before and after surgery was assessed using validated questionnaires - the Short Form 36 general health questionnaire ( SF36 ) and an Illness Behavior Questionnaire ( IBQ ) .
METHODS	Patients were asked to complete these questionnaires preoperatively and at 3 , 6 , 12 and 24 months postoperatively .
RESULTS	One hundred and twelve patients were randomized to undergo a Nissen fundoplication ( 52 ) or a 90 degrees anterior fundoplication ( 60 ) .
RESULTS	Patients who underwent anterior fundoplication reported significant improvements in eight of the nine SF36 scales compared to four of the nine following a Nissen fundoplication .
RESULTS	The majority of these improvements occurred early in the postoperative period .
RESULTS	With respect to the illness behavior data , there were no significant differences between the two procedures .
RESULTS	Both groups had a significant improvement in disease conviction scores at all time points compared to their preoperative scores .
CONCLUSIONS	Patients undergoing laparoscopic anterior 90 degrees partial fundoplication reported more QOL improvements in the early postoperative period than patients undergoing a Nissen fundoplication .
CONCLUSIONS	However , the QOL outcome for both procedures was similar at later follow-up .

###21288121
OBJECTIVE	This secondary analysis examined the efficacy and tolerability of atomoxetine ( ATX ) dosed once ( QD ) versus twice ( BID ) daily in 55 children aged 6-12 with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	The original 8-week trial was designed to assess the benefits of adding behavioral therapy to ATX .
METHODS	In it , all subjects were treated openly with ATX , with 50 % randomly assigned to additional behavioral treatments .
METHODS	Every subject was started on QD dosing with a target dose of 1.2 mg/kg per day .
METHODS	A switch to BID dosing was allowed at study midpoint to improve tolerability and efficacy .
METHODS	Subjects not responding to ATX at midpoint were also given the option of 0.6 mg/kg dose increase .
METHODS	ADHD and oppositional defiant disorder ( ODD ) symptoms , global functioning , side effects , and classroom performance were measured weekly .
RESULTS	There were 22 subjects ( 40 % ) who switched to BID dosing at midpoint ( mean dose = 1.56 mg/kg per day ) with the other 33 remaining on QD dosing ( mean dose = 1.33 mg/kg per day ) .
RESULTS	The BID group did not display any improvement in parent-rated ODD symptoms during the first 4 weeks of the study on QD dosing , but there was a significant improvement seen after the addition of the second ATX dose ( p < 0.05 ) .
RESULTS	However , BID dosing was not associated with differential rates of change for parent-rated ADHD symptoms or impairment , teacher ratings , or other measures of classroom functioning .
RESULTS	BID dosing was associated with decreased rates of stomachaches ( p < 0.05 ) but more persistent appetite loss than QD dosing .
RESULTS	The degree of improvement observed during the first half of the study in ratings of global impairment and ODD but not ADHD symptoms predicted a switch to BID dosing at midpoint ( p < 0.05 ) .
CONCLUSIONS	The addition of an afternoon dose of ATX was associated with improved control of ODD symptoms at home , with no change in school functioning .

###25211297
BACKGROUND	Children with severe cutaneous burn injury show persistent metabolic abnormalities , including inflammation and insulin resistance .
BACKGROUND	Such abnormalities could potentially increase their future risk for developing type 2 diabetes mellitus ( T2DM ) and cardiovascular disease ( CVD ) .
BACKGROUND	This could be related to changes in body composition and fat distribution .
METHODS	We studied body composition , fat distribution , and inflammatory cytokines changes in children with severe burn injury up to 6 months from discharge .
METHODS	Sixty-two boys and 35 girls ( burn 30 % of total body surface area ) were included .
RESULTS	We found a decrease in total body fat and subcutaneous peripheral fat at 6 months ( 6 % and 2 % , respectively ; P < 0.05 each ) .
RESULTS	An inverse correlation between the decrease in peripheral fat content at 6 months and the extent of burn injury ( r = -041 , P = 0.02 ) was also observed .
RESULTS	In addition , there was a 12 % increase in serum tumor necrosis factor - ( TNF - ) ( P = 0.01 vs. discharge ) and 9 % decrease in serum interleukin-10 ( IL-10 ) ( P < 0.0001 vs. discharge ) over 6 months after burn .
CONCLUSIONS	Severe burn injury in children is associated with changes in body fat content and distribution up to 6 months from hospital discharge .
CONCLUSIONS	These changes , accompanied by persisting systemic inflammation , could possibly mediate the observed persistence of insulin resistance , predisposing burn patients to the development of T2DM and CVD .

###24583632
BACKGROUND	WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients ( WEBCARE ) is a Web-based randomized controlled trial , designed to improve psychological well-being in patients with an implantable cardioverter defibrillator ( ICD ) .
BACKGROUND	As in other Web-based trials , we encountered problems with attrition and adherence .
OBJECTIVE	In the current study , we focus on the patient characteristics , reasons , and motivation of ( 1 ) completers , ( 2 ) those who quit the intervention , and ( 3 ) those who quit the intervention and the study in the treatment arm of WEBCARE .
METHODS	Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation .
METHODS	After signing consent and filling in baseline measures , patients were randomized to either the WEBCARE group or the Usual Care group .
RESULTS	The treatment arm of WEBCARE contained 146 patients .
RESULTS	Of these 146 , 34 ( 23.3 % ) completed the treatment , 88 ( 60.3 % ) dropped out of treatment but completed follow-up , and 24 ( 16.4 % ) dropped out of treatment and study .
RESULTS	Results show no systematic differences in baseline demographic , clinical , or psychological characteristics between groups .
RESULTS	A gradual increase in dropout was observed with 83.5 % ( 122/146 ) completing the first lesson , while only 23.3 % ( 34/146 ) eventually completed the whole treatment .
RESULTS	Reasons most often given by patients for dropout were technical problems with the computer , time constraints , feeling fine , and not needing additional support .
CONCLUSIONS	Current findings underline the importance of focusing on adherence and dropout , as this remains a significant problem in behavioral Web-based trials .
CONCLUSIONS	Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes .
BACKGROUND	Clinicaltrials.gov : NCT00895700 ; http://www.clinicaltrials.gov/ct2/show/NCT00895700 ( Archived by WebCite at http://www.webcitation.org/6NCop6Htz ) .

###11723431
BACKGROUND	In a double blind clinical study the efficacy , acceptability and safety of a mouthwash containing diclofenac 0.074 % DI-CO in patients undergone to oral or periodontal surgery was evaluated compared to placebo .
METHODS	The design was a randomised double blind controlled clinical study .
METHODS	The patients rinsed for 1 min twice a day with diclofenac mouthwash or placebo ( 15 mL ) at least after 1 hour since the chlorhexidine rinse for 7 days .
METHODS	Indistinguishable bottles and same appearance of the formulations guaranteed the reliability of the blindness .
METHODS	Pain at 8.00 pm the day of surgery and at 8.00 am the following day , inflammatory condition 24 hours after intervention , acceptability and safety were the parameters evaluated .
METHODS	Fifty ( 30 M , 20 F ) , mean aged 31.7 years , with pain score at the end of anaesthesia effect equivalent to 3.25 ( semi-quantitative scale ) were treated .
METHODS	At baseline the vital characteristics and the severity of the clinical condition were homogeneous in the two groups .
RESULTS	The mean severity score was significantly lower on DI-CO than the one showed on placebo both at 8.00 pm the day of surgery ( p = 0.003 ) and at 8.00 am the following day ( p = 0.001 ) .
RESULTS	The gingival inflammatory condition were significantly improved by DI-CO versus placebo ( p < 0.001 ) .
RESULTS	The good safety and pleasant palatability were similar for both treatments .
CONCLUSIONS	Diclofenac mouthwash presented very good efficacy and safety in the treatment of oral cavity phlogosis due to oral or periodontal surgery .

###18035098
BACKGROUND	To determine the effect of oral testosterone supplementation on systemic low-grade inflammation measured by high-sensitive C-reactive protein ( hs-CRP ) in aging men with low testosterone levels .
METHODS	Two hundred thirty-seven men aged 60 to 80 years with a testosterone level of < 13.7 nmol/L ( below the 50th percentile of the population distribution ) were recruited into a double-blind randomized placebo-controlled trial .
METHODS	Participants were randomized to either 4 capsules of 40 mg testosterone undecanoate ( Andriol Testocaps , NV Organon , Oss , The Netherlands ) or placebo daily for 26 weeks .
METHODS	Serum levels of hs-CRP were measured at baseline and at 26 weeks using a near-infrared particle immunoassay of the Synchron LX System ( Beckman Coulter , Fullteron , CA ) .
RESULTS	The median baseline hs-CRP level was 1.95 mg/L ( 0.30-6 .43 ) in the testosterone group compared with 1.90 mg/L ( 0.40-5 .91 ) in the placebo group .
RESULTS	After 26 weeks of testosterone supplementation therapy , the 2 intervention groups were not statistically significantly different ( median hs-CRP 2.20 vs 2.00 mg/L , interquartile range 0.40-6 .54 vs 0.50-5 .70 , P = .36 ) .
RESULTS	In subgroup analysis , neither baseline testosterone level , nor age , nor baseline CRP-level modified the effect of testosterone supplementation on CRP levels .
CONCLUSIONS	Oral testosterone undecanoate supplementation , in dosage of 160 mg daily for 26 weeks , does not increase hs-CRP levels in elderly men .

###17119047
BACKGROUND	Smoking , alcohol use , and depression are interrelated and highly prevalent in patients with head and neck cancer , adversely affecting quality of life and survival .
BACKGROUND	Smoking , alcohol , and depression share common treatments , such as cognitive behavioral therapy and antidepressants .
BACKGROUND	Consequently , we developed and tested a tailored smoking , alcohol , and depression intervention for patients with head and neck cancer .
METHODS	Patients with head and neck cancer with at least one of these disorders were recruited from the University of Michigan and three Veterans Affairs medical centers .
METHODS	Subjects were randomized to usual care or nurse-administered intervention consisting of cognitive behavioral therapy and medications .
METHODS	Data collected included smoking , alcohol use , and depressive symptoms at baseline and at 6 months .
RESULTS	The mean age was 57 years .
RESULTS	Most participants were male ( 84 % ) and White ( 90 % ) .
RESULTS	About half ( 52 % ) were married , 46 % had a high school education or less , and 52 % were recruited from Veterans Affairs sites .
RESULTS	The sample was fairly evenly distributed across three major head and neck cancer sites and over half ( 61 % ) had stage III/IV cancers .
RESULTS	Significant differences in 6-month smoking cessation rates were noted with 47 % quitting in the intervention compared with 31 % in usual care ( P < 0.05 ) .
RESULTS	Alcohol and depression rates improved in both groups , with no significant differences in 6-month depression and alcohol outcomes .
CONCLUSIONS	Treating comorbid smoking , problem drinking , and depression may increase smoking cessation rates above that of usual care and may be more practical than treating these disorders separately .

###8259749
OBJECTIVE	To compare the rate of obstetric interventions , length of labor , and maternal morbidity in pregnancies with prelabor rupture of membranes at term after either early or late induction of labor in both primiparous and pluriparous women .
METHODS	Prospective , randomized study .
METHODS	362 women with singleton pregnancies , cephalic presentations , gestational age of 36 completed weeks or more were allocated at random to induction with oxytocin either 6 hours after PROM ( n = 62 ) ( early ) or 24 hours ( n = 62 ) ( late ) .
METHODS	Those eligible , but not participating in the study , totalled 238 women .
METHODS	MAIN OBSTETRIC MEASURES : Time of spontaneous labor in the late induction group , length of labor , obstetric intervention rate , maternal morbidity , and the degree of histologic chorioamnionitis .
RESULTS	The length of labor was longer in the late induction group than in the early induction group in both primiparous and pluriparous ( p < 0.05 ) .
RESULTS	There were no overall differences in the rate of obstetric interventions or maternal morbidity , but there were marked differences between primiparous and pluriparous women .
RESULTS	Increasing time span between the period from rupture of membranes to delivery increased the degree of histologic chorioamnionitis .
CONCLUSIONS	If a woman wants a short labor , she will benefit from early induction .
CONCLUSIONS	We did not find statistical differences in the rate of obstetric intervention or in the maternal morbidity , but there was a tendency towards adverse effects of late induction .

###24423407
BACKGROUND	The effects of tongue cleaning on reconstruction of bacterial flora in dental plaque and tongue coating itself are obscure .
BACKGROUND	We assessed changes in the amounts of total bacteria as well as Fusobacterium nucleatum in tongue coating and dental plaque specimens obtained with and without tongue cleaning .
METHODS	We conducted a randomized examiner-blind crossover study using 30 volunteers ( average 23.7 3.2 years old ) without periodontitis .
METHODS	After dividing randomly into 2 groups , 1 group was instructed to clean the tongue , while the other did not .
METHODS	On days 1 ( baseline ) , 3 , and 10 , tongue coating and dental plaque samples were collected after recording tongue coating score ( Winkel tongue coating index : WTCI ) .
METHODS	After a washout period of 3 weeks , the same examinations were performed with the subjects allocated to the alternate group .
METHODS	Genomic DNA was purified from the samples and applied to SYBR Green-based real-time PCR to quantify the amounts of total bacteria and F. nucleatum .
RESULTS	After 3 days , the WTCI score recovered to baseline , though the amount of total bacteria in tongue coating was significantly lower as compared to the baseline .
RESULTS	In plaque samples , the bacterial amounts on day 3 and 10 were significantly lower than the baseline with and without tongue cleaning .
RESULTS	Principal component analysis showed that variations of bacterial amounts in the tongue coating and dental plaque samples were independent from each other .
RESULTS	Furthermore , we found a strong association between amounts of total bacteria and F. nucleatum in specimens both .
CONCLUSIONS	Tongue cleaning reduced the amount of bacteria in tongue coating .
CONCLUSIONS	However , the cleaning had no obvious contribution to inhibit dental plaque formation .
CONCLUSIONS	Furthermore , recovery of the total bacterial amount induced an increase in F. nucleatum in both tongue coating and dental plaque .
CONCLUSIONS	Thus , it is recommended that tongue cleaning and tooth brushing should both be performed for promoting oral health .

###15125464
BACKGROUND	Although the ` test-and-treat ' strategy is suggested as first-line therapy for uninvestigated dyspepsia , no large-scale studies in a real-life setting are available .
METHODS	1552 dyspeptic patients aged between 25 and 60 with no alarm symptoms were recruited to the study .
METHODS	After screening with a 13C-urea breath test , they were randomized into three treatment arms : Helicobacter pylori-positive either to eradication therapy with OAM ( omeprazole , amoxycillin and metronidazole ) ( Hp + / erad ) or omeprazole 20 mg daily ( Hp + / ome ) for 10 days , whereas H. pylori-negative patients ( Hp - / ome ) were treated with 20 mg omeprazole for 10 days .
METHODS	Gastrointestinal symptoms were registered at baseline at 1 and 2 years on the Gastrointestinal Symptom Rating Scale ( GSRS ) and quality of life with the Psychological General Well-Being index ( PGWB ) .
METHODS	Additional visits , referrals for and number of endoscopies and their findings were registered during the 2 years ' follow-up .
RESULTS	Of the 1552 patients , 583 were H. pylori-positive ( 37.6 % ) , and 288 of these were randomized for omeprazole and 295 to OAM .
RESULTS	The Hp - / ome group had fewer general practitioner ( GP ) contacts ( P < 0.0001 ) than the H. pylori-positive groups .
RESULTS	Eradication therapy significantly improved general well-being and reduced upper gastrointestinal symptoms : abdominal pain ( P = 0.0001 ) , heartburn ( P = 0.0061 ) , acid regurgitation ( P = 0.003 ) , hunger pain ( P = 0.009 ) , especially in Hp + / erad .
RESULTS	Peptic ulcer was found in 6.2 % , 1.0 % , 0.2 % in Hp + / ome , Hp - + / erad and Hp - / ome , respectively ( P = 0.0007 ) .
RESULTS	Only 3 patients ( 1.0 % ) developed peptic ulcers in Hp - + / erad , all eradication failures .
CONCLUSIONS	In uninvestigated dyspepsia , a negative test result for H. pylori reduces the number of GP contacts and endoscopy referrals compared to H. pylori-positive regardless of eradication therapy .
CONCLUSIONS	Applied in real life , the test-and-treat strategy failed to reduce the number of endoscopies , but significantly reduced peptic ulcer disease and improved dyspeptic symptoms and quality of life .

###11094856
OBJECTIVE	The oral bioavailability of cefuroxime axetil is enhanced by food .
OBJECTIVE	This study was done to compare the effect of two types of Indian breakfast on the bioavailability of cefuroxime axetil in healthy volunteers .
METHODS	Eight healthy male volunteers participated in the crossover study .
METHODS	Subjects were randomized to receive either one of the two types of breakfast , Diet-A or Diet-B , 10 min before single dose of 500 mg cefuroxime axetil .
METHODS	After a washout period of one week the study was repeated with the other type of diet .
METHODS	Diet-A included idly with chutney .
METHODS	Diet-B included poori and dal-fry .
METHODS	Blood samples for pharmacokinetic analysis were obtained prior to dosing and at 0.25 , 0.50 , 0.75 , 1.0 , 1.5 , 2.0 , 2.5 , 3.0 , 4.0 , 5.0 , 6.0 and 8.0 h following dosing and urine collections were done for 8 h.
METHODS	The serum and urine samples were assayed by using HPLC .
RESULTS	The AUC and Cmax were significantly increased after oral administration of cefuroxime axetil with Diet-B , when compared to Diet-A ( P < 0.01 and P < 0.02 respectively ) .
RESULTS	The values of apparent absorption rate constant , lag-time , Tmax and t1/2 beta for the two regimens were not significantly different .
RESULTS	The volume of distribution and plasma clearance for cefuroxime were significantly lower ( P < 0.02 , P < 0.001 respectively ) in the regimen with Diet-B .
RESULTS	The 8 h urinary recovery of cefuroxime was 16.59 and 28.44 per cent ( P < 0.005 ) with Diet-A and Diet-B respectively .
CONCLUSIONS	The administration of cefuroxime axetil with poori and dal-fry may enhance the bioavailability when compared with idly and chutney .

###17359649
BACKGROUND	This study assessed effects of acupuncture as an add-on to conventional antihypertensive managements such as medication or lifestyle modification for hypertensive or pre-hypertensive subjects .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted at Kyung Hee University Hospital .
METHODS	Forty-one hypertensive or pre-hypertensive ( systolic BP > or = 120 mmHg or diastolic BP > or = 80 mmHg ) volunteers were recruited and randomly assigned into real or sham acupuncture groups .
METHODS	The hypertensive subjects on antihypertensive medication continued their medication .
METHODS	Acupuncture point prescriptions were partially individualized , based on the Saam acupuncture theory .
METHODS	Park 's sham needle method was adopted for the sham procedure .
METHODS	Measurements were performed at baseline , weeks 4 and 8 .
METHODS	BP , scales of overall health and pain , and anticipation or satisfaction for the treatments , were recorded .
RESULTS	Thirty subjects completed the intervention , all of whom were on antihypertensive medication .
RESULTS	The sham acupuncture group showed no significant change in mean BP , while the real acupuncture group showed a significant ( p < 0.01 ) decrease in mean BP after 8 weeks of intervention from 136.8 / 83.7 to 122.1 / 76.8 mmHg .
RESULTS	Other factors showed no difference between the groups throughout the study .
CONCLUSIONS	Acupuncture seems to offer an additional benefit to the treatment of hypertensive patients .

###10198505
BACKGROUND	A third of patients with schizophrenia are out of contact with secondary services .
BACKGROUND	Many of these patients receive maintenance medication as depot antipsychotics from practice nurses , most of whom have negligible training in mental health .
OBJECTIVE	To examine the impact of a structured assessment on the process of care and clinical status of schizophrenia patients by practice nurses who received a one-day training course .
METHODS	All identified patients were randomly allocated to structured assessments and outcome , measured by the number of assessments and the changes in care recorded in primary care notes .
METHODS	A comprehensive assessment of clinical and social functioning and level of unmet need in intervention and control patients was carried out after one year by an independent researcher .
RESULTS	A high rate of consultation and clinical need in this patient group was demonstrated .
RESULTS	Practice nurses were more diligent in carrying out assessments than general practitioners ( GPs ) , but there was no impact on treatment patterns or clinical outcome .
CONCLUSIONS	Structured assessments by practice nurses are feasible with this patient group , but training , targeted at both nurses and GPs , is needed if this intervention is to translate into health gain .

###15695544
BACKGROUND	Chronic sciatica can be managed by caudal steroid epidural or by targeted steroid placement during spinal endoscopy .
BACKGROUND	Spinal endoscopy is a new unproven procedure .
BACKGROUND	We aimed to compare the two pain management techniques and to investigate whether the site of steroid placement within the epidural space was significant .
METHODS	We randomized 60 patients with a 6-18 months history of sciatica to either targeted epidural local anaesthetic and steroid placement with a spinal endoscope or caudal epidural local anaesthetic and steroid treatment .
METHODS	Pre-treatment and 6-week , 3-month , and 6-month SF-MPQ and HAD scores were recorded .
RESULTS	No significant differences were found between the groups for any of the measures at any time .
RESULTS	However , there were significant differences within both groups compared with pre-treatment values .
RESULTS	For the caudal group , significant improvements were found for descriptive pain at 6 months ( P = 0.031 ) , VAS at 6 weeks ( P = 0.036 ) , 3 months ( P = 0.026 ) , and 6 months ( P = 0.003 ) , present pain intensity ( PPI ) at 3 months ( P = 0.013 ) and 6 months ( P = 0.01 ) ; anxiety at 6 weeks ( P = 0.008 ) , 3 months ( P = 0.004 ) , and 6 months ( P = 0.001 ) and depression at 6 months only ( P = 0.037 ) .
RESULTS	For the epiduroscopy group there were fewer significant changes .
RESULTS	PPI was significantly reduced at 6 weeks ( P = 0.004 ) and at 6 months ( P = 0.02 ) .
RESULTS	Anxiety was reduced at 6 months only ( P = 0.03 ) .
CONCLUSIONS	The targeted placement of epidural steroid onto the affected nerve root causing sciatica does not significantly reduce pain intensity and anxiety and depression compared with untargeted caudal epidural steroid injection .
CONCLUSIONS	When analysed individually , both techniques benefited patients .

###17855735
BACKGROUND	The aim of this study was to examine the efficacy of epidurally administered mepivacaine on recovery from vecuronium-induced neuromuscular block .
METHODS	Eighty patients were randomly assigned to one of two study groups .
METHODS	They were either given epidurally a bolus of 0.15 ml kg ( -1 ) of mepivacaine 2 % , followed by repetitive injections of 0.1 ml kg ( -1 ) h ( -1 ) throughout the study , or were not given epidurally .
METHODS	General anaesthesia was induced and maintained with fentanyl , propofol and nitrous oxide .
METHODS	Neuromuscular block was induced with vecuronium 0.1 mg kg ( -1 ) and monitored using acceleromyographic train-of-four ( TOF ) at the adductor pollicis .
METHODS	Patients in each treatment group were randomized to receive neostigmine 0.04 mg kg ( -1 ) at 25 % recovery of the first twitch of TOF or to recover spontaneously to a TOF ratio of 0.9 .
METHODS	The effect of epidural mepivacaine on speed of spontaneous and facilitated recovery of neuromuscular function was evaluated .
RESULTS	The time from administration of vecuronium to spontaneous recovery to a TOF ratio of 0.9 was significantly longer in the epidural mepivacaine group [ 105.4 ( 14.2 ) min ] as compared with the control group [ 78.5 ( 9.1 ) min , P < 0.01 ] .
RESULTS	Neostigmine administered at 25 % of control in T1 shortened recovery from neuromuscular block , however the time required for facilitated recovery to a TOF ratio of 0.9 in the epidural group was significantly longer than that in the control group [ 7.6 ( 1.6 ) min vs 5.8 ( 2.1 ) min , P < 0.01 ] .
CONCLUSIONS	In clinical anaesthesia , it should be recognized that epidurally administered mepivacaine delays considerably the TOF recovery from neuromuscular block .

###19933962
BACKGROUND	Studies have demonstrated that blood pressure ( BP ) control can be improved when clinical pharmacists assist with patient management .
BACKGROUND	The objective of this study was to evaluate if a physician and pharmacist collaborative model in community-based medical offices could improve BP control .
METHODS	This was a prospective , cluster randomized , controlled clinical trial with clinics randomized to a control group ( n = 3 ) or to an intervention group ( n = 3 ) .
METHODS	The study enrolled 402 patients ( mean age , 58.3 years ) with uncontrolled hypertension .
METHODS	Clinical pharmacists made drug therapy recommendations to physicians based on national guidelines .
METHODS	Research nurses performed BP measurements and 24-hour BP monitoring .
RESULTS	The mean ( SD ) guideline adherence scores increased from 49.4 ( 19.3 ) at baseline to 53.4 ( 18.1 ) at 6 months ( 8.1 % increase ) in the control group and from 40.4 ( 22.6 ) at baseline to 62.8 ( 13.5 ) at 6 months ( 55.4 % increase ) in the intervention group ( P = .09 for adjusted between-group comparison ) .
RESULTS	The mean BP decreased 6.8 / 4.5 mm Hg in the control group and 20.7 / 9.7 mm Hg in the intervention group ( P < .05 for between-group systolic BP comparison ) .
RESULTS	The adjusted difference in systolic BP was -12.0 ( 95 % confidence interval [ CI ] , -24.0 to 0.0 ) mm Hg , while the adjusted difference in diastolic BP was -1.8 ( 95 % CI , -11.9 to 8.3 ) mm Hg .
RESULTS	The 24-hour BP levels showed similar effect sizes .
RESULTS	Blood pressure was controlled in 29.9 % of patients in the control group and in 63.9 % of patients in the intervention group ( adjusted odds ratio , 3.2 ; 95 % CI , 2.0-5 .1 ; P < .001 ) .
CONCLUSIONS	A physician and pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates compared with a control group .
CONCLUSIONS	Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management .
BACKGROUND	clinicaltrials.gov Identifier : NCT00201019 .

###17159759
OBJECTIVE	Propofol has a high incidence of pain on injection , particularly when a vein on the back of hand is used .
OBJECTIVE	Administration of lidocaine , either before or mixed with propofol remains the most widely used method to attenuate this pain .
OBJECTIVE	The use of opioids such as alfentanil and fentanyl has been found to decrease pain induced by propofol injection .
OBJECTIVE	The purpose of this study was to evaluate the effects of different doses of remifentanil and alfentanil in minimizing the pain caused by propofol .
METHODS	In this randomized , double-blind , placebo-controlled study , healthy premedicated children between the age group of 5-12 years admitted for adenotonsillectomy were randomly allocated to one of 6 treatment groups .
METHODS	Group I : remifentanil 0.25 microg kg ( -1 ) ; Group II : remifentanil 0.50 microg kg ( -1 ) ; Group III : alfentanil 15 microg kg ( -1 ) ; Group IV : alfentanil 20 microg kg ( -1 ) 60 s prior to propofol mixed with 1 mL of 0.9 % normal saline ; Group V : lidocaine 1 mL of 1 % ( 10 mg ) added to 100 mg of propofol and Group VI : normal saline .
METHODS	During the injection of propofol ( 3 mg kg ( -1 ) ) pain perception was assessed with a four-point behavioural scale : none , mild , moderate , or severe .
RESULTS	There were 52 subjects in Group I , 51 in Group II , 49 in Group III , 52 in Group IV , 52 in Group V and 52 in Group VI ; 63.46 % of patients in Group I , 39.21 % in Group II , 38.77 % in Group III , 36.53 % in Group IV , 38.46 % in Group V and 84.61 % in Group VI experienced pain .
RESULTS	Statistically , Groups II , III , IV and V were significantly better than placebo in the reduction of propofol pain ( P < 0.0001 ) .
RESULTS	Groups II , III and IV significantly reduced the pain in comparison with Group I ( P < 0.001 ) .
CONCLUSIONS	Pretreatment with intravenous remifentanil 0.5 microg kg ( -1 ) , alfentanil 15 microg kg ( -1 ) and 20 microg kg ( -1 ) were equally effective in reducing pain associated with propofol injection in children between the age group of 5-12 years .

###19222654
OBJECTIVE	This paper is a report of a study to compare a medical grade honey with conventional treatments on the healing rates of wounds healing by secondary intention .
BACKGROUND	There is an increasing body of evidence to support the use of honey to treat wounds , but there is a lack of robust randomized trials on which clinicians can base their clinical judgement .
METHODS	A sample of 105 patients were involved in a single centre , open-label randomized controlled trial in which patients received either a conventional wound dressing or honey .
METHODS	Data were collected between September 2004 and May 2007 .
RESULTS	The median time to healing in the honey group was 100 days compared with 140 days in the control group .
RESULTS	The healing rate at 12 weeks was equal to 46.2 % in the honey group compared with 34.0 % in the conventional group , and the difference in the healing rates ( 95 % confidence interval , CI ) at 12 weeks between the two groups was 12.2 % ( -13.6 % , 37.9 % ) .
RESULTS	The unadjusted hazard ratio ( 95 % CI ) from a Cox regression was equal to 1.30 ( 0.77 , 2.19 ) , P = 0.321 .
RESULTS	When the treatment effect was adjusted for confounding factors ( sex , wound type , age and wound area at start of treatment ) , the hazard ratio increased to 1.51 but was again not statistically significant .
CONCLUSIONS	Wound area at start of treatment and sex are both highly statistically significant predictors of time to healing .
CONCLUSIONS	These results support the proposition that there are clinical benefits from using honey in wound care , but further research is needed .

###23770179
OBJECTIVE	The aim of this study was to assess the lipid-altering efficacy and safety of ETC-1002 in subjects with hypercholesterolemia .
BACKGROUND	ETC-1002 is a small molecule that modulates pathways of cholesterol , fatty acid , and carbohydrate metabolism and may have therapeutic benefits in treating hypercholesterolemia and other cardiometabolic risk factors .
METHODS	This multicenter , randomized , double-blind , placebo-controlled , parallel-group trial evaluated patients ( n = 177 ) with elevated low-density lipoprotein cholesterol ( LDL-C ) ( 130 to 220 mg/dl ) , who were stratified by baseline triglycerides ( not elevated [ < 150 mg/dl ] or elevated [ 150 - < 400 mg/dl ] ) and randomized to receive 40 , 80 , or 120 mg of ETC-1002 or placebo once daily for 12 weeks .
METHODS	Outcomes included changes in LDL-C ( primary endpoint ) , other lipids , and cardiometabolic risk factors ; and safety .
RESULTS	ETC-1002 40 , 80 , and 120 mg lowered least-squares mean SE LDL-C levels by 17.9 2.2 % , 25.0 2.1 % , and 26.6 2.2 % , respectively , versus a reduction of 2.1 2.2 % with placebo ( all , p < 0.0001 ) ; LDL-C lowering was similar between the subgroups with nonelevated and elevated triglycerides .
RESULTS	ETC-1002 also lowered non-high-density lipoprotein cholesterol ( non-HDL-C ) , apolipoprotein B , and LDL particle number ( all , p < 0.0001 ) in a dose-dependent manner ; HDL-C and triglyceride levels were relatively unchanged .
RESULTS	Post-hoc analyses suggest that ETC-1002 may have favorable effects on other cardiometabolic risk factors .
RESULTS	The ETC-1002 and placebo groups did not demonstrate clinically meaningful differences in adverse events or other safety assessments .
CONCLUSIONS	ETC-1002 significantly lowered LDL-C levels up to 27 % across a broad range of baseline triglycerides and was generally safe and well tolerated .
CONCLUSIONS	ETC-1002 has a novel mechanism of action and may be useful for reducing LDL-C .
CONCLUSIONS	( A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides ; NCT01262638 ) .

###24345444
OBJECTIVE	Memantine , an uncompetitive N-methyl-d-aspartate receptor antagonist , is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer 's disease .
OBJECTIVE	Anecdotal reports have suggested that memantine may improve neurologic and cognitive symptoms of individuals with the neurodegenerative disease fragile X-associated tremor/ataxia syndrome ( FXTAS ) ; however , its efficacy and safety in this population have not been assessed in a controlled trial .
METHODS	Individuals with FXTAS aged 34-80 years were enrolled in a randomized , double-blind , placebo-controlled , 1-year trial between September 2007 and August 2012 .
METHODS	Inclusion required definite , probable , or possible FXTAS in clinical stages 1-5 according to previously published criteria .
METHODS	Primary outcome measures were the Behavioral Dyscontrol Scale ( BDS ) score and CATSYS intention tremor severity .
RESULTS	Ninety-four participants were randomized from 205 screened ; of those , 43 and 45 started treatment with memantine ( titrated to 10 mg twice daily ) and placebo , respectively .
RESULTS	Thirty-four participants receiving memantine and 36 receiving placebo completed the 1-year endpoint assessment ( n = 70 ) .
RESULTS	Intention-to-treat analysis showed no improvement with respect to intention tremor severity ( mean [ SD ] values with memantine vs placebo : 1.05 [ 0.73 ] vs 1.89 [ 2.19 ] , P = .047 ) or BDS score ( 16.12 [ 5.43 ] vs 15.72 [ 3.93 ] , P = .727 ) at follow-up .
RESULTS	Post hoc analyses of participants with early FXTAS ( stage 3 ) , those with late FXTAS ( stage > 3 ) , and those in different age groups ( 65 years and > 65 years ) also indicated no significant improvement .
RESULTS	More frequent mild adverse events were observed in the placebo group , while more frequent moderate adverse events occurred in the memantine group ( P = .007 ) .
CONCLUSIONS	This randomized , double-blind , placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures .
BACKGROUND	ClinicalTrials.gov identifier : NCT00584948 .

###17086095
BACKGROUND	Several neurohumoral mechanisms involved in cardiovascular regulation are activated in the failing heart , but only limited information is available regarding the influence of long-term nitrate therapy .
METHODS	This was a double-blind , randomized comparison of isosorbide-5-mononitrate ( IS-5-MN ) , 60 mg given orally , once daily for 11 months to patients ( n = 47 ) with left ventricular ( LV ) dysfunction following acute myocardial infarction ( AMI ) .
METHODS	Forty-five patients received placebo .
METHODS	All patients received ramipril.Plasma natriuretic peptides ( atrial [ ANP ] and brain [ BNP ] natriuretic peptide ) , epinephrine , norepinephrine ( NEPI ) , antidiuretic hormone , aldosterone ( Aldo ) , renin activity ( PRA ) , substance P , neuropeptide Y-like immunoreactivity , calcitonin gene-related peptide , and vasoactive intestinal peptide were measured at baseline and at the end of the treatment period .
METHODS	Clinical , echocardiographic , and hemodynamic data were also obtained .
CONCLUSIONS	Chronic nitrate therapy does not significantly affect the neurohumoral status in patients with LV dysfunction after AMI , apart from a decrease in ANP .
CONCLUSIONS	Some hormones are more closely associated with diastolic dysfunction/increased volume load ( ANP and BNP ) and others are more closely associated with systolic dysfunction ( PRA , NEPI , Aldo ) .
CONCLUSIONS	There is a temporal dissociation of these 2 groups of hormones 1 year post infarction : ANP and BNP decrease , whereas NEPI and Aldo show a slight increase .
CONCLUSIONS	BNP levels do not reflect all important pathophysiologic mechanisms in heart failure .
CONCLUSIONS	Consequently , the use of other neurohormonal factors than BNP for monitoring of heart failure therapy should be explored .

###19363561
OBJECTIVE	To investigate whether transcutaneous electrical stimulation , when applied to acupuncture points in patients after acute stroke , decreases spasticity and/or increases muscle strength more effectively than placebo stimulation and standard rehabilitation .
METHODS	Randomized control trial .
METHODS	Sixty-two patients aged 70.0 ( standard deviation 7.4 ) years and 9.2 ( standard deviation 3.4 ) days post-stroke .
METHODS	The patients were randomly assigned to 3 groups receiving transcutaneous electrical stimulation , placebo stimulation , or standard rehabilitation alone .
METHODS	Stimulation was applied to 4 acupuncture points in the affected lower leg for 60 min , 5 days a week for 3 weeks .
METHODS	Plantarflexor spasticity , ankle muscle strength , and functional mobility were measured before treatment , weekly during treatment , and at follow-up at week 8 post-stroke .
RESULTS	No significant difference was found in the outcome measures among groups before treatment .
RESULTS	When compared with standard rehabilitation or placebo stimulation , transcutaneous electrical stimulation to acupuncture points significantly increased the percentage of patients with normal tone , increased ankle dorsiflexor strength , and decreased antagonist co-contraction ratio ( p < 0.05 ) .
RESULTS	The patients in the transcutaneous electrical stimulation group also tended to walk 2-4 days earlier than the patients in the other 2 groups .
CONCLUSIONS	Three weeks of transcutaneous electrical stimulation to lower leg acupuncture points , given 5 times a week within 10 days post-stroke , significantly decreased ankle plantarflexor spasticity , and increased dorsiflexor strength concomitant with a decrease in antagonist co-contraction .

###24571205
OBJECTIVE	To gain further evidence on the efficacy , safety and tolerability of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .
METHODS	Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5mg ( n = 306 ) or placebo ( n = 304 ) for 12 weeks .
RESULTS	A significantly greater improvement ( P < 0.001 ) in total International Prostate Symptom Score for the change from baseline ( week 0 ) to study end-point ( week 12 ) was observed for tadalafil ( -6.0 ) versus placebo ( -4.5 ) .
RESULTS	Significantly greater improvements ( P < 0.01 ) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo .
RESULTS	Significantly greater improvements ( P < 0.05 ) in International Prostate Symptom Score voiding and storage subscores , and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo .
RESULTS	Significantly greater improvements ( P < 0.001 ) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement .
RESULTS	No new safety concerns were identified .
CONCLUSIONS	These findings confirm the efficacy and safety profile of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .

###9207647
OBJECTIVE	The purpose of this study was to compare chronic changes in monophasic and biphasic defibrillation thresholds using a uniform transvenous lead system and testing protocol .
BACKGROUND	Defibrillation thresholds increase over time in patients with nonthoracotomy lead systems .
BACKGROUND	This increase can result in an inadequate chronic defibrillation safety margin and could limit the safety of smaller pulse generators , which have a reduced maximal output .
BACKGROUND	However , previous studies of the temporal changes of defibrillation thresholds evaluated complex lead systems or monophasic shock waveforms , neither of which are used with current technology .
METHODS	This study was a prospective , randomized assessment of the effects of shock waveforms on the changes of transvenous defibrillation thresholds over time .
METHODS	Paired monophasic and biphasic thresholds were measured both at implantation and at follow-up ( 250 + / - 105 days ) in 24 consecutive patients who were not receiving antiarrhythmic drugs .
METHODS	The lead system was a dual-coil Endotak C lead , and reverse polarity shocks ( distal coil = anode ) were delivered .
RESULTS	Monophasic defibrillation thresholds increased from ( mean + / - SD ) 13.7 + / - 6.0 J to 16.8 + / - 6.7 J ( p = 0.02 ) , whereas biphasic thresholds were unchanged ( 10.4 + / - 4.3 J to 10.2 + / - 4.8 J , p = 0.86 ) in the same patients .
RESULTS	Shock impedance chronically increased ( 47.0 omega to 50.5 omega , p = 0.02 ) and was unaffected by waveform .
CONCLUSIONS	These results indicate that biphasic shocks prevent the chronic increase in defibrillation thresholds with a transvenous lead system .

###15148202
BACKGROUND	Extracapsular cataract extraction ( ECCE ) with a posterior chamber intraocular lens ( PC IOL ) is the preferred method of cataract surgery in developed countries .
BACKGROUND	However , intracapsular cataract extraction ( ICCE ) with an anterior chamber lens ( AC IOL ) may be appropriate in rural Africa .
BACKGROUND	A randomised controlled trial was carried out to compare these surgical strategies .
METHODS	Participants over 50 years requiring bilateral cataract surgery were recruited from outreach clinics in rural north and east Uganda .
METHODS	One eye was randomly allocated to AC IOL or PC IOL , the other eye being allocated to the second strategy .
METHODS	The main outcome measure was WHO distance visual acuity ( VA ) category after a minimum of 1 year .
METHODS	Secondary outcomes were numbers and causes of complications and refractive corrections .
RESULTS	Of the 110 participants recruited , 98 ( 89 % ) were assessed at least 1 year after the operation ( median follow up 17.5 months ) .
RESULTS	Nine eyes randomised to PC IOL were converted to AC IOL ; one eye randomised to AC IOL inadvertently received PC IOL .
RESULTS	There was no difference in VA between 95 pairs of eyes for which data for both eyes were available ( uncorrected VA , p = 0.26 ; corrected VA , p = 0.59 ) .
RESULTS	80 ( 82 % , 95 % CI 73 to 89 ) and 82 ( 84 % , 95 % CI 75 to 90 ) eyes randomised to AC IOL and PC IOL respectively had corrected VA of 6/18 or better .
RESULTS	16 ( 16 % , 95 % CI 10 to 25 ) and eight ( 8 % , 95 % CI 4 to 15 ) eyes respectively had secondary procedures or other complications .
CONCLUSIONS	Where both strategies are available , ECCE with PC IOL should be first choice because of fewer complications .
CONCLUSIONS	Where ECCE with PC IOL is not immediately feasible , ICCE with AC IOL is an acceptable interim technique .

###10513492
OBJECTIVE	To determine the level of examination skills of internal medicine residents and to assess whether an intervention by trained persons with arthritis could have a greater impact on their examination skills than participation in an ambulatory care training experience .
METHODS	Twenty-seven residents attended a 6-week ambulatory care rotation that included didactic teaching as well as attendance at an outpatient arthritis clinic with supervision by rheumatologists .
METHODS	Sixteen residents were randomly assigned to have a training encounter with an arthritis educator along with the standard experience in the arthritis clinic , whereas 11 residents received training in the arthritis clinic only .
METHODS	Arthritis educators evaluated the musculoskeletal examination skills of each resident during the first week of the rotation .
METHODS	The 16 residents in the intervention group received instruction on joint examination techniques by the arthritis educator immediately following their evaluation .
METHODS	At the end of the 6-week rotation , the groups were re-evaluated by a different arthritis educator .
METHODS	A group of 21 rheumatologists was also asked to perform a comprehensive musculoskeletal examination on individual arthritis educators .
METHODS	The arthritis educators assessed the examination of the rheumatologists using the same evaluation instrument that was used to assess the residents .
RESULTS	Initially , internal medicine residents carried out the musculoskeletal examination poorly ( 34.2 + / - 0.09 % correct , n = 27 ) .
RESULTS	By contrast , the rheumatologists carried out a significantly greater amount of the examination correctly ( 54.5 + / - 0.05 % ) .
RESULTS	The musculoskeletal examination skills of the residents who received additional training from an arthritis educator were significantly greater at the end of the rotation than the group who did not receive this intervention ( 50.5 + / - 0.10 % versus 41.9 + / - 0.14 % correct , P = 2.15 x 10 ( -5 ) .
CONCLUSIONS	Internal medicine residents carried out the musculoskeletal examination poorly .
CONCLUSIONS	However , an intervention by arthritis educators improved the musculoskeletal examination skills of internal medicine residents significantly and more effectively than the standard clinical teaching in a rheumatology outpatient clinic .
CONCLUSIONS	The impact of the arthritis educator intervention persisted for at least 5 weeks .

###19386869
OBJECTIVE	This study compared the efficacy in terms of pain of injection , time of onset and duration of action of digital blocks of bupivacaine 0.5 % alone and lidocaine 1 % with epinephrine ( 1:100,000 ) .
METHODS	A randomised double-blind prospective study was performed in a single self-controlled group of 12 healthy volunteers ( 4 women , 8 men ) .
METHODS	Each participant was randomised to receive either lidocaine 1 % with epinephrine ( 1:100,000 ) or bupivacaine 0.5 % in either the right or left middle finger .
METHODS	Pain of injection was measured as the primary outcome using a 0-100 mm visual analogue scale .
METHODS	The time before anaesthesia to pinpricks was recorded and the duration of anaesthesia was reported by all volunteers .
METHODS	Statistical analysis was conducted using the non-parametric Wilcoxon signed rank test .
RESULTS	Median visual analogue scale scores were significantly different between the lidocaine + epinephrine and bupivacaine groups ( 26.00 mm ( 4-52 ) vs 40.50 mm ( 10-71 ) , p < 0.05 ) .
RESULTS	The median time before anaesthesia to pinpricks was not significantly different between the two drugs ( 3.45 min ( 3-8 ) vs 3.30 min ( 3-8 ) , p = 0.84 ) .
RESULTS	The median time needed for return of pinpricks was significantly different between the two drugs ( 321 min ( 228-463 ) vs 701 min ( 245-913 ) , p < 0.05 ) .
RESULTS	Follow-up was completed at 24 h.
CONCLUSIONS	Lidocaine ( 1 % ) with epinephrine ( 1:100 000 ) was significantly less painful and had a shorter duration of action than bupivacaine ( 0.5 % ) , which had a similar onset of action for digital nerve block .
BACKGROUND	ISRCTN45121950 .

###16817738
OBJECTIVE	To evaluate whether use of recombinant human ( rh ) thyroid-stimulating hormone ( TSH ) induces equivalent stimulation , compared with bovine TSH ( bTSH ) , and to evaluate activity of rhTSH in dogs of various large breeds .
METHODS	18 healthy research Beagles and 20 healthy client-owned dogs of various breeds with body weight > 20 kg .
METHODS	The 18 Beagles were randomly assigned to 3 groups , and each dog received either 75 microg of rhTSH , IM or IV , or 1 unit of bTSH , IM , respectively , in a crossover design .
METHODS	The 20 client-owned dogs received 75 microg of rhTSH , IV .
METHODS	Blood samples were taken before and 6 hours after TSH administration for determination of total serum thyroxine ( T ( 4 ) ) concentration .
METHODS	Additional blood samples were taken after 2 and 4 hours in Beagles that received rhTSH , IM .
RESULTS	There was a significant increase in T ( 4 ) concentration in all dogs , but there were no differences between values obtained after administration of bTSH versus rhTSH or IV versus IM administration of rhTSH .
RESULTS	Although there was a significant difference in age and body weight between Beagles and non-Beagles , there was no difference in post-TSH simulation T ( 4 ) concentration between the 2 groups .
CONCLUSIONS	Results indicated an equivalent biological activity of rhTSH , compared with bTSH .
CONCLUSIONS	Use of 75 microg of rhTSH , IV , did not induce a different magnitude of stimulation in large-breed dogs , compared with Beagles .
CONCLUSIONS	Euthyroidism was confirmed if post-TSH simulation T ( 4 ) concentration was > or = 2.5 microg/dL and at least 1.5 times basal T ( 4 ) concentration .

###8361795
OBJECTIVE	Emollient cream moisturizers are often used on premature newborns in neonatal intensive care units without accurate knowledge of the risks or benefits to the neonate .
METHODS	We prospectively compared premature neonates treated with a water-in-oil emollient cream for up to 16 days to untreated premature neonates .
METHODS	The study was completed in a neonatal intensive care unit on neonates admitted for respiratory distress and/or possible sepsis .
METHODS	Thirty-four neonates , between 29 and 36 weeks estimated gestational age , entered the study .
METHODS	One-half of the neonates were treated twice a day with an water-in-oil emollient cream , and the other half served as controls .
METHODS	The skin condition of the neonates ' hands , feet , and abdomen was evaluated on entering the study and twice a week .
METHODS	Fungal cultures and quantitative bacterial cultures were obtained from the axilla and abdomen on entering the study and twice a week .
RESULTS	The mean gestational age of the treated neonates was 32.3 weeks , whereas the mean gestational age of the control neonates was 32.5 weeks .
RESULTS	The neonates treated with emollient cream demonstrated statistically less dermatitis of their hands ( day 2 through day 11 ) , their feet ( day 2 through day 16 ) , and their abdomen ( day 7 through day 11 ) .
RESULTS	Fungal cultures and quantitative bacterial cultures of the abdomen and axilla were equivalent in both groups .
CONCLUSIONS	These studies document that emollient cream moisturizer therapy of premature neonates decreases dermatitis without changing the microbiological flora .

###21389753
BACKGROUND	Psychotherapy added to pharmacotherapy results in greater improvement in clinical outcomes than does pharmacotherapy alone .
BACKGROUND	However , few studies examined how psychotherapy coupled with pharmacotherapy could produce a long-term protective effect by improving the psychobiological stress response .
METHODS	The researchers recruited 63 subjects with major depressive disorder ( MDD ) in an outpatient department of psychiatry at a general hospital .
METHODS	The randomly assigned subjects formed 2 groups : 29 in combined therapy ( COMB ) and 34 in monotherapy ( MT ) .
METHODS	The COMB included 8 weekly body-mind-spirit group psychotherapy sessions added to pharmacotherapy .
METHODS	MT consisted of pharmacotherapy only .
METHODS	The outcome measures , collected at the subjects ' homes , included the Beck Depression Inventory II ( BDI-II ) , the State Trait Anxiety Inventory ( STAI ) and salivary cortisol on awakening , 45 min after awakening , and at 12.00 , 17.00 and 21.00 h. Evaluation of outcome measures was at baseline condition , and at months 2 ( end of additional psychotherapy ) , 5 and 8 .
RESULTS	While the decreases in symptoms of depression were similar between COMB and MT ( p > 0.05 ) , the reductions in anxiety state were greater in COMB than in MT during the 8-month follow-up ( p < 0.05 ) .
RESULTS	A steeper diurnal cortisol pattern more likely occurred in COMB than in MT in the 3 follow-up periods ( p < 0.05 , p < 0.001 and p < 0.01 ) .
CONCLUSIONS	The superior outcomes of group psychotherapy added to pharmacotherapy for MDD outpatients could relate to decreasing the anxiety state and to producing long-term impacts on positive stress endocrine outcomes seen as a steeper diurnal cortisol pattern .

###23085096
OBJECTIVE	Limited endoscopic sphincterotomy with large balloon dilation ( ESBD ) is an alternative to endoscopic sphincterotomy ( ES ) for removing bile duct stones , but it is not clear which procedure is most effective .
OBJECTIVE	We compared the 2 techniques in removal of bile duct stones .
METHODS	Between September 2005 and September 2011 , 156 consecutive patients with suspected of having , or known to have , common bile duct stones were randomly assigned to groups that underwent ES or ESBD .
METHODS	Patients in the ESBD group underwent limited sphincterotomy ( up to half of the sphincter ) followed by balloon dilation to the size of the common bile duct or 15 mm , and patients in the ES group underwent complete sphincterotomy alone .
METHODS	Stones were then removed using standard techniques .
METHODS	The primary outcome was percentage of stones cleared , and secondary outcomes included procedural time , method of stone extraction , number of procedures required for stone clearance , morbidities and mortality within 30 days , and direct cost .
RESULTS	There was no significant difference between groups in percentage of stones cleared ( ES vs ESBD : 88.5 % vs 89.0 % ) .
RESULTS	More patients in the ES group ( 46.2 % ) than the ESBD group ( 28.8 % ) required mechanical lithotripsy ( P = .028 ) , particularly for stones 15 mm ( 90.9 % vs 58.1 % ; P = .002 ) .
RESULTS	Morbidities developed in 10.3 % of patients in the ES group and 6.8 % of patients in the ESBD group ( P = .46 ) .
RESULTS	The cost of the hospitalization was also significantly lower in the ESBD group ( P = .034 ) .
CONCLUSIONS	ESBD and ES clear bile stones with equal efficacy .
CONCLUSIONS	However , ESBD reduces the need for mechanical lithotripsy and is less expensive ; ClinicalTrials.gov number , NCT00164853 .

###24494281
OBJECTIVE	To observe the difference in the clinical efficacy on oculomotor impairment between electroacupuncture and acupuncture and explore the best therapeutic method in the treatment of this disease .
METHODS	Sixty cases of oculomotor impairment were randomized into an electroacupuncture group and an acupuncture group , 30 cases in each one .
METHODS	In the electroacupuncture group , the points were selected on extraocular muscles , the internal needling technique in the eye was used in combination of electroacupuncture therapy .
METHODS	In the acupuncture group , the points and needling technique were same as the electroacupuncture group , but without electric stimulation applied .
METHODS	The treatment was given 5 times a week , 15 treatments made one session .
METHODS	After 3 sessions of treatment , the clinical efficacy , palpebral fissure size , pupil size , oculomotor range and the recovery in diplopia were compared before and after treatment in the two groups .
RESULTS	In the electroacupuncture group , the palpebral fissure size was ( 9.79 + / -2.65 ) mm and the eyeball shifting distance was ( 18.12 + / -1.30 ) mm , which were hig-her than ( 8.23 + / -2.74 ) mm and ( 16.71 + / -1.44 ) mm respectively in the acupuncture group .
RESULTS	In the electroacupuncture group , the pupil diameter was ( 0.44 + / -0.42 ) mm , which was less than ( 0.72 + / - 0.53 ) mm in the acupuncture group , indicating the significant difference ( all P < 0.05 ) .
RESULTS	The cured rate was 63.33 % ( 19/30 ) and the total effective rate was 93.33 % ( 28/30 ) in the electroacupuncture group , which was better than 36.67 % ( 11/30 ) and 83.333 ( 25/30 ) in the acupuncture group separately , indicating the significant difference ( all P < 0.05 ) .
CONCLUSIONS	Electroacupuncture presents the obvious advantages in the treatment of oculomotor impairment , characterized as quick and high effect , short duration of treatment and remarkable improvements in clinical symptoms , there are important significance for the improvement of survival quality of patients .

###25234040
OBJECTIVE	To determine whether endometrial hCG infusion at the time of human blastocyst transfer impacts implantation rates .
METHODS	Randomized double-blinded placebo-controlled trial .
METHODS	Academic .
METHODS	Infertile couples with the female partner less than 43 years old ( n = 300 ) undergoing fresh or frozen ET of one or two blastocysts .
METHODS	Patients undergoing ET were randomized into either a treatment or a control group .
METHODS	The treatment group received an infusion of 500 IU of hCG diluted in ET media .
METHODS	The control group received a sham infusion of ET media .
METHODS	Infusions were done using a separate catheter less than 3 minutes before actual ET .
METHODS	Sustained implantation rate : ongoing viable gestation ( primary outcome ) and ongoing pregnancy rate ( secondary outcome ) .
RESULTS	A total of 473 blastocysts were transferred into 300 patients .
RESULTS	There were no differences between the two groups in sustained implantation rate ( 48.1 % in the hCG group , 44.2 % in the control group ) or ongoing pregnancy rate ( 58.8 % in the hCG group , 52.0 % in the control group ) .
CONCLUSIONS	Endometrial infusion of hCG at the time of blastocyst ET does not improve sustained implantation rates .
BACKGROUND	NCT01643993 .

###11788216
OBJECTIVE	The aim of this study was to determine whether nicotine , a constituent of cigarette smoke , contributes to acute endothelial dysfunction after smoking one cigarette .
BACKGROUND	Animal studies suggest that nicotine might cause an impairment of endothelium-dependent vasodilation via an increase in oxidative stress .
METHODS	Sixteen healthy smokers were entered into a randomized , observer-blinded crossover study comparing the effects of nicotine nasal spray ( 1-mg nicotine ) and cigarette smoke ( 1-mg nicotine , 12 mg tar ) on vascular reactivity in the brachial artery .
METHODS	Using high-resolution ultrasound , flow-mediated dilation ( FMD ) and endothelium-independent , nitroglycerin-induced dilation were assessed at baseline and 20 min after the administration of nicotine ( spray or cigarette ) .
RESULTS	In response to similar increases in nicotine serum levels , FMD values declined from 10.2 + / - 4.4 % to 6.7 + / - 4.0 % after the spray ( mean difference : -3.6 + / - 2.0 % , 95 % confidence interval : -4.6 ; -2.5 , p < 0.0001 ) and from 9.4 + / - 3.8 % to 4.3 + / - 2.8 % after the cigarette ( -5.1 + / - 2.6 % , -6.5 ; -3.7 , p < 0.0001 ) .
RESULTS	Nitroglycerin-induced dilation remained similar within both periods .
RESULTS	Performing a period effect analysis of variance , a significant influence on FMD was found for the mode of administration ( p = 0.017 ) and the baseline value ( p = 0.021 ) .
RESULTS	The effect on FMD was more pronounced after the cigarette than after the spray ( estimated average effect difference : 1.9 % FMD ) .
RESULTS	Oxidation parameters did not increase significantly after nicotine spray or tobacco exposure .
CONCLUSIONS	These results demonstrate that nicotine alone causes acute endothelial dysfunction , although to a lesser extent than smoking a cigarette of the same nicotine yield .
CONCLUSIONS	However , the precise mechanisms by which nicotine leads to this altered vascular reactivity remain unclear .

###11975091
BACKGROUND	Reboxetine is a selective noradrenaline reuptake inhibitor ( NARI ) .
BACKGROUND	As noradrenaline plays a relevant role in antinociceptive mechanisms , the hypothesis was investigated in this study whether reboxetine has analgetic efficacy .
METHODS	Twenty-four healthy volunteers were investigated in a crossover design .
METHODS	Reboxetine ( 2 x 2 mg ) or placebo were given for 5 days with the `` crossover '' following a one-day washout in between .
METHODS	The primary end-points were the N1 and P2 amplitudes of laser evoked somatosensory potentials ( laser SEP ) of vertex EEG .
METHODS	In addition , visual analogue scales ( VAS , 100 mm ) were used .
RESULTS	Reboxetine showed a higher analgesic potency than placebo , with a statistically significant superiority in capsaicinirritated skin -- in the objective tests ( laser SEP , P < 0.0001 for N1 and P = 0.0002 for P2 ) as well as in the subjective pain measurements ( VAS , P < 0.0003 ) .
RESULTS	Besides pain , the subjective feelings of burning and itching were lower with reboxetine than with the placebo .
CONCLUSIONS	The hypothesis that a selective noradrenergic substance could be of analgesic efficacy was proven the first time experimentally .
CONCLUSIONS	Reboxetine reduced the N1 and the P2 components of the laser SEP , which speaks for central and peripheral mechanisms of action .

###25790672
OBJECTIVE	To evaluate the clinical efficacy and safety of Qiangji Recipe ( QR ) in ad - junctive treatment of axial undifferentiated spondyloarthritis ( axuSpA ) through a four-week open study .
METHODS	Fifty-four axuSpA patients of Shen-deficiency Du-channel cold syndrome ( SDDCS ) in line with inclusive criteria were recruited and assigned to the treatment group and the control group according to random digit table , 27 in each group .
METHODS	Patients in the control group took Celecoxib Capsule ( 0.2 g each time , twice per day ) .
METHODS	Patients in the treatment group additionally took QR ( consisting of Herba Epimedii 15 g , antler glue 15 g , Cibotium Barometz 15 g , eucommia bark 20 g , dipsacus asper 10 g , two toothed achyranthes root 15 g , drynaria 15 g , Taxillus Chinensis 20 g , ground beetle 10 g , scorpion 5 g , wild celery 10 g , notopterygium incisium 10 g , cow-fat seed 10 g , white mustard seed 6 g , and licorice root 6 g , one dose per day , twice daily ) .
METHODS	The therapeutic course for all was 4 weeks .
METHODS	The Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath AS Metrology Index ( BASMI ) , total body pain and spinal pain , patient and physician global assessment on a four-point scale , the Ankylosing Spondylitis Quality of Life ( ASQoL ) , erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) were measured before and after 4 weeks of treatment .
METHODS	The primary end point in this study was the proportion of patients with a 20 % improvement response accord - ing to the ASAS International Working Group Criteria ( ASAS 20 responders ) at week 4 .
RESULTS	Totally 50 patients completed this trial , 26 in the treatment group and 24 in the control group .
RESULTS	Improvement of BASDAI , BASFI , BASMI , ASQoL , ESR , and CRP was shown in both groups after treatment .
RESULTS	Better effect was shown in the treatment group in all indices except ESR and BASMI after treatment ( P < 0.05 , P < 0.01 ) .
RESULTS	Twenty cases ( accounting for 76.92 % ) in the treatment group achieved ASAS 20 response at week 4 , while 12 cases ( accounting for 50.00 % ) in the control group achieved ASAS 20 response at week 4 ( P < 0.05 ) .
RESULTS	No obvious adverse reaction occurred in the two groups .
CONCLUSIONS	QR combined Celecoxib Capsule showed better effect in treating axuSpA patients than using Celecoxib Capsule alone .

###16957432
BACKGROUND	The use of multiple topical drugs for the treatment of acne may cause elevated irritation .
BACKGROUND	Therefore , the selection of a combination regimen should include a careful consideration of the irritation potential of the individual acne medications .
OBJECTIVE	To compare the cumulative irritation potential of adapalene gel 0.1 % , tazarotene cream 0.05 % , and tretinoin microsphere 0.04 % when applied in combination with two benzoyl peroxide/clindamycin topical gels in 35 healthy subjects in a 3-week , randomized , controlled study .
RESULTS	The mean cumulative irritancy index of adapalene combinations was significantly lower relative to tretinoin and tazarotene regimens ( all P < .01 ) .
RESULTS	Test areas exposed to tretinoin or tazarotene were also more likely to be discontinued for severe irritation than those exposed to adapalene .
RESULTS	There were no serious adverse events .
RESULTS	No significant difference in the irritancy potentials of tazarotene and tretinoin combination regimens was observed .
CONCLUSIONS	Adapalene gel 0.1 % has tolerability superior to both tazarotene cream 0.05 % and tretinoin microsphere 0.04 % when used in topical combination therapy .
CONCLUSIONS	In view of the lower irritation potential observed in this study , along with its demonstrated efficacy , adapalene gel 0.1 % in combination with antimicrobial agents may be used as part of an aggressive treatment regimen for the management of acne .

###23490403
OBJECTIVE	Patients with chronic obstructive pulmonary disease ( COPD ) presenting with acute hypercapnic respiratory failure ( AHcRF ) benefit from non-invasive ventilation ( NIV ) .
OBJECTIVE	The best way to withdraw NIV is not known , and we conducted a pilot study comparing stepwise versus immediate withdrawal of NIV in these patients .
METHODS	This was a prospective , single-centre , open-labelled randomized study comparing stepwise versus immediate withdrawal of NIV in patients with COPD exacerbation recovering from AHcRF .
METHODS	The primary end-point was the success rate of NIV withdrawal , defined as no restarting of NIV from randomization to 48h after complete withdrawal of NIV .
RESULTS	Sixty patients were randomized , 35 patients to stepwise withdrawal and 25 patients to immediate withdrawal .
RESULTS	The two study arms were clinically comparable .
RESULTS	There was no statistically significant difference in the success rate , with NIV successfully stopped in 74.3 % and 56 % in the stepwise and immediate withdrawal groups , respectively ( P = 0.139 ) .
CONCLUSIONS	We could not show any benefits for either strategy to withdraw NIV .
CONCLUSIONS	The study may have been underpowered to detect differences , and larger prospective studies are required .

###17440366
BACKGROUND	This study was designed to compare two-layer palatoplasty ( Wardill-Kilner V-Y pushback technique ) without intravelar veloplasty versus three-layer palatoplasty ( Kriens technique ) with intravelar veloplasty with regard to postoperative functional outcome of eustachian tube and velopharyngeal competence .
METHODS	A prospective cohort study was conducted enrolling 70 patients with nonsyndromic cleft palate ( except submucous type of cleft ) over a period of 2 years .
METHODS	They were divided into two main groups according to the type of cleft palate : group A ( Veau class II ) included 32 patients and group B ( Veau class I ) included 38 patients .
METHODS	In each group , Wardill-Kilner palatoplasty ( two-layer repair without intravelar veloplasty ) versus Kriens palatoplasty ( three-layer repair with intravelar veloplasty ) was randomly selected for patients .
RESULTS	For the three-layer palatoplasty in both groups , there was a greater tendency for resolution of secretory otitis media in the early postoperative period , less time required for extrusion of the grommet tube , and a lower incidence of recurrent secretory otitis media .
RESULTS	The incidence of postoperative velopharyngeal incompetence was greater with two-layer palatoplasty group .
RESULTS	The incidence of palatal fistula was greater with three-layer palatoplasty .
CONCLUSIONS	Palatal muscle reconstruction in cleft palate patients confers better functional results regarding velopharyngeal competence and eustachian tube function .
CONCLUSIONS	Although the overall incidence of postoperative palatal fistula is within the accepted range , the incidence of fistula is higher in the palatal muscle reconstruction subgroup .
CONCLUSIONS	Future studies are required that include a larger number of patients .

###22456954
OBJECTIVE	Allergic rhinitis ( AR ) is regulated by the local production and release of several cytokines .
OBJECTIVE	Allergen specific immunotherapy ( IT ) has been widely used for many years as a specific treatment of allergic diseases .
OBJECTIVE	This study aimed to investigate the changes in clinical and immunological markers before and after Phoenix dactylifera IT in AR patients .
METHODS	Total symptom score and levels of total immunoglobulin E ( IgE ) , albumin , interferon ( IFN ) - , tumor necrosis factor ( TNF ) - , interleukin ( IL ) -10 , IL-4 , and IL-13 were measured in the serum and nasal samples of thirty non-atopic healthy controls and thirty patients with allergic rhinitis before and after 15 months of IT .
RESULTS	We found significantly higher concentrations of serum TNF - and nasal TNF - and IL-13 , and significantly lower concentration of nasal IL-10 , in allergic patients than in non-allergic .
RESULTS	Moreover , serum and nasal IL-10 increased significantly after IT .
RESULTS	However , there was neither a significant reduction in total IgE nor a significant increase in IFN - at the end of IT .
CONCLUSIONS	Our data show a clinical improvement associated with a decline in some inflammation parameters after IT .
CONCLUSIONS	Moreover , date palm IT induced a significant increase in serum and nasal IL-10 levels .

###1572037
BACKGROUND	Systemic hypertension is a well-known risk factor for coronary artery disease and sudden cardiac death .
BACKGROUND	Recent interest focused on the presence of malignant ventricular arrhythmias ( VA ) and myocardial ischemia in hypertensive patients and provided a potential link for fatal tachyarrhythmic events .
RESULTS	We studied 150 untreated normokalemic hypertensive patients ( 56 + / - 9 years ; 56 women and 94 men ) without manifest coronary artery disease to determine prevalence , severity , and interaction of VA and significant ST segment changes induced by daily activities .
RESULTS	One third of the patients were randomized to 4 weeks of placebo and restudied for spontaneous variability of the two parameters .
RESULTS	All patients were included in a 3-year follow-up study .
RESULTS	VA were observed in 129 of 150 hypertensive patients ( 86 % ) and peaked in the early morning and late afternoon .
RESULTS	Twenty-two patients ( 15 % ) had ventricular pairs , and 20 patients ( 13 % ) had nonsustained ventricular tachycardia .
RESULTS	Transient ST segment depression observed in 47 patients ( 33 % ; mean incidence , 2.7 + / - 0.8 episodes/24 hr ) showed a characteristic circadian variation similar to VA and were asymptomatic in 93 % of the episodes .
RESULTS	At the time of transient ST segment depression , VA increased 4.6 times ( p less than 0.01 ) .
RESULTS	After 4 weeks of placebo , marked variations in the incidence of VA ( VA suppression rate -100 % , or increase greater than 400 % ) were observed in 29 % of the patients , and in 60 % of all patients repetitive VA were present in only one of the two Holter recordings .
RESULTS	Day-and-night variations of VA and transient ST segment changes were highly reproducible during the placebo period .
RESULTS	After 3 years of follow-up , eight of 146 patients ( 5 % ) had suffered myocardial infarction , and five patients had died from cardiac events ( three patients died from sudden cardiac death ) .
RESULTS	Logistic regression analysis revealed left ventricular hypertrophy ( relative risk , 6.1 ; p less than 0.01 ) and transient ST segment abnormalities during daily activities ( relative risk , 4.4 ; p less than 0.05 ) to be of independent prognostic significance to predict cardiac events during follow-up instead of repetitive VA ( relative risk , 1.3 ; NS ) .
CONCLUSIONS	VA associated with a high spontaneous variability and predominantly asymptomatic transient ST segment changes are common in hypertensives ; the interaction of both risk factors may provide an important link for fatal VA. .
CONCLUSIONS	Antiarrhythmic therapy is not to be recommended in the majority of patients .
CONCLUSIONS	Presence of left ventricular hypertrophy and transient ST segment changes were the most powerful predictors of cardiac events during the follow-up .

###24799181
OBJECTIVE	Non-surgical therapies are needed to reduce the rate of progression of low-grade cervical intraepithelial neoplasia ( CIN 1 ) to high grade CIN ( CIN 2/3 ) .
OBJECTIVE	The aim of this study was to assess the efficacy and safety of hexaminolevulinate ( HAL ) photodynamic therapy ( PDT ) in the treatment of patients with CIN 1 .
METHODS	This phase IIa prospective double-blind study randomized patients with CIN 1 into three groups : HAL vaginal suppository , placebo vaginal suppository or follow-up only .
METHODS	Patients in the first two groups received HAL or placebo suppositories 5hours before illumination with 50J/cm ( 2 ) red coherent light ( 633nm ) using a special light catheter .
METHODS	All patients had a follow up including colposcopy , cytology and human papilloma virus ( HPV ) testing 3 and 6 months and additional biopsy 6 months after PDT .
METHODS	The main outcome measure was efficacy , defined as complete histologic remission 6 months after PDT .
METHODS	Secondary outcomes were histologic remission 3 months and HPV eradication 6 months after first PDT .
RESULTS	Seventy patients were randomized : 47 to HAL , 12 to placebo , 11 to follow up only .
RESULTS	After 6 months CIN lesions had cleared in 57 % of patients in the HAL-PDT group compared to 25 % in the combined control group ( per protocol population , P = 0.04 ) .
RESULTS	Twenty-six patients ( 37 % ) reported 44 adverse events ( AEs ) , of which 40 were mild or moderate .
RESULTS	Nineteen treatment-related AEs were reported by 15 patients ( 32 % ) in the HAL PDT group , one in the placebo PDT group ( 8 % ) , and none in the follow-up group .
RESULTS	The most common adverse events were local discomfort including mild pain/cramping ( 11 ) and leucorrhoea ( 2 ) .
CONCLUSIONS	HAL PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with CIN 1 .

###19854713
OBJECTIVE	Dehydroepiandrosterone ( DHEA ) has been reported to improve fatigue and reduced well-being .
OBJECTIVE	Both are major problems in patients with systemic lupus erythematosus ( SLE ) , even with quiescent disease .
OBJECTIVE	Low serum DHEA levels are common in SLE .
OBJECTIVE	The present work investigates the effects of DHEA administration on fatigue , well-being and functioning in women with inactive SLE .
METHODS	In a double-blind , randomised , placebo-controlled study , 60 female patients with inactive SLE received 200 mg oral DHEA or placebo .
METHODS	Primary outcome measures were general fatigue , depressive mood , mental well-being and physical functioning .
METHODS	Assessments were made before treatment , after 3 , 6 and 12 months on medication , and 6 months after cessation of treatment .
RESULTS	Patients from the DHEA and placebo group improved on general fatigue ( p < 0.001 ) and mental well-being ( p = 0.04 ) .
RESULTS	There was no differential effect of DHEA .
RESULTS	The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA ( p = 0.04 ) .
CONCLUSIONS	The trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being , and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE .
CONCLUSIONS	Clinical Trials Registration Number NCT00391924 .

###17630036
BACKGROUND	The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined .
BACKGROUND	Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer .
METHODS	We randomly assigned 820 patients with advanced colorectal cancer to receive either first-line treatment with capecitabine , second-line irinotecan , and third-line capecitabine plus oxaliplatin ( sequential treatment ; n = 410 ) or first-line treatment capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin ( combination treatment ; n = 410 ) .
METHODS	The primary endpoint was overall survival .
METHODS	Analyses were done by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov with the number NCT00312000 .
RESULTS	17 patients ( nine in the sequential treatment group , eight in the combination group ) were found to be ineligible and were excluded from the analysis .
RESULTS	675 ( 84 % ) patients died during the study : 336 in the sequential group and 339 in the combination group .
RESULTS	Median overall survival was 16.3 ( 95 % CI 14.3-18 .1 ) months for sequential treatment and 17.4 ( 15.2-19 .2 ) months for combination treatment ( p = 0.3281 ) .
RESULTS	The hazard ratio for combination versus sequential treatment was 0.92 ( 95 % CI 0.79-1 .08 ; p = 0.3281 ) .
RESULTS	The frequency of grade 3-4 toxicity over all lines of treatment did not differ significantly between the two groups , except for grade 3 hand-foot syndrome , which occurred more often with sequential treatment than with combination treatment ( 13 % vs 7 % ; p = 0.004 ) .
CONCLUSIONS	Combination treatment does not significantly improve overall survival compared with the sequential use of cytotoxic drugs in advanced colorectal cancer .
CONCLUSIONS	Thus sequential treatment remains a valid option for patients with advanced colorectal cancer .

###21305536
BACKGROUND	Rebleeding from peptic ulcers is a major contributor to death .
BACKGROUND	This study compared standard ( 40-mg intravenous infusion of omeprazole once daily for 3 days ) and high-dose ( 80-mg bolus of omeprazole followed by 8-mg/h infusion for 72 h ) in reducing the rebleeding rate ( primary endpoint ) , need for surgery , duration of hospital stay and mortality in patients with peptic ulcer bleeding after successful endoscopic therapy .
METHODS	This was a single-institution prospective randomized controlled study based on a postulated therapeutic equivalence of the two treatments .
METHODS	All patients who had successful endoscopic haemostasis of a bleeding peptic ulcer ( Forrest classification Ia , Ib , IIa or IIb ) were recruited .
METHODS	Informed consent was obtained and patients were randomized to receive standard - or high-dose infusions of intravenous omeprazole .
RESULTS	Two ( 3 per cent ) of 61 patients in the high-dose group and ten ( 16 per cent ) of 61 in the standard-dose group exhibited rebleeding , a difference of - 13 ( 95 per cent confidence interval - 25 to - 2 ) per cent .
RESULTS	The upper limit of the one-sided confidence interval exceeded a predefined equivalence absolute difference of 16 per cent .
RESULTS	Equivalence of standard - and high-dose omeprazole in preventing rebleeding was not demonstrated .
CONCLUSIONS	Intravenous standard-dose omeprazole was inferior to high-dose omeprazole in preventing rebleeding after endoscopic haemostasis for peptic ulcer bleeding .
BACKGROUND	NCT00519519 ( http://www.clinicaltrials.gov ) .

###19489234
OBJECTIVE	To explore the indications and key points of anterolateral minimally-invasive total hip arthroplasty .
METHODS	110 baseline indexes matched patients admitted for unilateral total hip arthroplasty were randomly assigned to 2 equal groups to undergo surgery through a short anterolateral incision of < or = 10 cm or a standard posterolateral incision .
METHODS	All operations were done by the same surgeon .
METHODS	The demographic data , perioperative indexes , and postoperative function indexes were recorded and statistically analyzed .
RESULTS	No significant differences were detected with respect to operation time , abduction angle , anteversion angle , stem alignment , and stem fixation between these 2 groups .
RESULTS	The incision length , blood loss , perioperative transfusion , and 100 - mm visual analogue pain scale ( VAS ) score at the first 24 hours of the anterolateral approach group were ( 7.49 + / - 0.86 ) cm , ( 376.18 + / - 168.30 ) ml , ( 410.09 + / - 136.46 ) ml , and ( 30.76 + / - 21.77 ) respectively , all significantly shorter , less , or lower than those of the standard posterolateral approach group [ ( 15.2 + / - 1.8 ) cm , ( 605.0 + / - 225.1 ) ml , ( 629.5 + / - 232.9 ) ml , and ( 50.3 + / - 13.7 ) respectively , all P < 0.01 ] .
RESULTS	The Harris hip score and Barthel index 3 months after operation of the anterolateral approach group were ( 83.80 + / - 5.64 ) and ( 93.45 + / - 6.37 ) respectively , both significantly higher than those of the standard posterolateral approach group [ ( 75.0 + / - 7.5 ) and ( 94.6 + / - 7.5 ) respectively , both P < 0.01 ) ] , however , there were not significant differences in the Harris hip score and Barthel index 3 years after operation between these 2 groups .
CONCLUSIONS	Fewer traumas , less blood loss and rapid recovery can be obtained through this new total hip arthroplasty approach .
CONCLUSIONS	But experienced doctors and special instruments are prerequisite .

###16708003
BACKGROUND	Current understanding of implementation methods is limited , and research has focused on changing doctors ' behaviors .
OBJECTIVE	Our aim was to evaluate the impact of audit and feedback and educational outreach in improving nursing practice and patient outcomes .
METHODS	Using a factorial design , cluster randomized controlled trial , we evaluated 194 community nurses in 157 family practices and 1078 patients with diagnosis of urinary incontinence ( UI ) for nurses compliance with evidence-linked review criteria for the assessment and management of UI and impact on psychologic and social well-being and symptoms .
METHODS	In the outreach arms , nurses ' self-reported barriers informed development of tailored strategies .
RESULTS	In comparison with educational materials alone , the implementation methods tested did not improve care at 6 months follow-up .
RESULTS	Moderate rates of improvement ( 10-17 % of patients ) in performance for the assessment of UI and greater rates of improvement ( 20-30 % of patients ) for the management of care were found but effects were similar across arms .
RESULTS	Improvement in patient outcomes was more consistently positive for educational outreach than for audit and feedback but differences were not significant .
RESULTS	Adjustment for caseload size , severity or duration of UI and patients ' age did not alter results .
CONCLUSIONS	Printed educational materials alone may be as effective as audit and feedback and educational outreach in improving nurses ' performance and outcomes of care for people with UI .
CONCLUSIONS	Greater understanding of the underlying processes in improving performance within multidisciplinary teams through further , theory-driven studies with `` no intervention '' control groups and longer follow-up are needed .

###19641919
OBJECTIVE	Oral temozolomide is approved in many countries for malignant glioma and for melanoma in some countries outside the USA .
OBJECTIVE	This study evaluated the exposure equivalence and safety of temozolomide by intravenous infusion and oral administration .
METHODS	Subjects with primary central nervous system malignancies ( excluding central nervous system lymphoma ) received 200 mg/m ( 2 ) of oral temozolomide on days 1 , 2 and 5 .
METHODS	On days 3 and 4 , subjects received 150 mg/m ( 2 ) temozolomide either as a 90-min intravenous infusion on one day or by oral administration on an alternate day .
RESULTS	Ratio of log-transformed means ( intravenous : oral ) of area under the concentration-time curve and maximum concentration of drug after dosing for temozolomide and 5 - ( 3-methyltriazen-1-yl ) imidazole-4-carboxamide ( MTIC ) met exposure equivalence criteria ( 90 % confidence interval = 0.8-1 .25 ) .
RESULTS	Treatment-emergent adverse events were consistent with those reported previously in subjects with recurrent glioma treated with oral temozolomide , except for mostly mild and transient injection site reactions with intravenous administration .
CONCLUSIONS	This study demonstrated an exposure equivalence of a 90-min intravenous infusion of temozolomide and an equivalent oral dose .

###12586006
OBJECTIVE	To compare the accuracy of the breath test using the isotope ratio mass spectrometer ( IRMS ) versus the nondispersive isotope-selective infrared spectrometer ( NDIRS ) in the diagnosis of Helicobacter pylori infection .
METHODS	Multicenter study in 4 Spanish hospitals .
METHODS	One group of dyspeptic patients who had not undergone prior eradication therapy and another group of patients with gastric ulcer or gastrointestinal bleeding due to gastroduodenal ulcer receiving H. pylori eradication therapy were included in the study .
METHODS	A reference standard based on histology and the rapid urease test was used .
METHODS	The breast test ( TAU-KIT , Isomed S.L. , Madrid , Spain ) was performed with citric acid and 100 mg of 13C-urea .
METHODS	Samples of expired air were collected in tubes and bags for reading with the IRMS ( ABCA , PDZ , Crewe , Manchester , England ) and the NDIRS ( UBiT-IR200 , Otsuka Electronics , Co , Osaka , Japan ) , respectively .
METHODS	The endoscopist , pathologist and person responsible for reading the urease test and both breath tests were blinded to the results of the other diagnostic methods .
RESULTS	Forty-one patients were included .
RESULTS	The prevalence of H. pylori was 26 % .
RESULTS	No differences were found on comparing the mean values obtained with the IRMS and the NDIRS : 13 ( standard deviation ) ( 24 ) and 14 ( 25 ) delta units , respectively .
RESULTS	The area under the ROC curve for the IRMS and the NDIRS was 0.96 .
RESULTS	The diagnostic accuracy for the best cut-off point with the IRMS and the NDIRS was , respectively : sensitivity ( 90 and 100 % ) , specificity ( 96 and 89 % ) , positive predictive value ( 90 and 77 % ) , negative predictive value ( 96 and 100 % ) , + likelihaod ratio ( 25 and 9.3 ) and ( 0.1 and 0 ) .
RESULTS	A close correlation was found between the values of the IRMS and those of the NDIRS ( lineal regression equation , Y = 1.1 + 1.004 .
RESULTS	X ; r = 0.97 ) .
CONCLUSIONS	Both the spectrometers used to evaluate the breath test , the IRMS and the NDIRS , offer a high degree of accuracy in the diagnosis of H. pylori infection .

###25242059
BACKGROUND	Individuals with physical disabilities experience disparities in obesity ; yet few interventions have incorporated accommodations necessary for weight loss in this population .
OBJECTIVE	This project compared the effectiveness of two weight loss interventions among individuals with physical disabilities .
METHODS	Adults with physical disabilities who were overweight or obese were randomized across two diet approaches : a modified version of the MyPlate diet ( usual care ( UC ) ) and a modified Stoplight Diet ( SLDm ) supplemented with portion-controlled meals .
METHODS	Project staff met monthly with each participant to measure weight , 24-recalls of diet intake , self-tracking of foods and beverages , and physical activity during the preceding month .
RESULTS	Of 126 enrollees , 70 % completed the initial 6-month diet phase and 60 % of these completed a 6-month follow-up phase .
RESULTS	Participants in the SLDm group reduced weight and BMI during the 6 month intervention , and maintained or lost more weight during the 6 month maintenance period .
RESULTS	Alternately , the UC diet resulted in a reduction in weight and BMI only at 6 months .
RESULTS	BMI from baseline was significantly more improved for SLDm than UC and , among those who lost weight , the SLDm group lost more weight at 6 and 12 months .
CONCLUSIONS	These results demonstrate that interventions with proper design and accommodations can overcome the barriers to weight loss unique to individuals with mobility impairments with low income .
CONCLUSIONS	Additionally , the results suggest that using portion control may be more effective than teaching portion sizes .

###11999539
OBJECTIVE	To determine whether glycemic index ( GI ) differentially affects improved glucose and lipid profiles observed during weight loss in overweight subjects previously diagnosed with type 2 diabetes with variable glucose tolerance .
METHODS	Twenty-three female and twenty-two male overweight subjects participated in 12 weeks of energy restriction ( average BMI 33.2 kg/m2 , age 56.7 years , glycated hemoglobin ( GHb ) 6.7 % ) .
METHODS	After a four-week run-in on a high saturated fat ( SFA ) diet ( 1540 kcal/day , 17 % SFA ) , the free-living subjects were randomly assigned to either a high - ( 75 GI units ) or low - ( 43 GI units ) GI diet ( 1440 kcal/day , 60 % carbohydrate , 5 % SFA ) for eight weeks .
METHODS	Weight , serum lipids , plasma glucose and glycated hemoglobin were measured every four weeks .
METHODS	An oral glucose tolerance test ( OGTT ) was also performed at baseline , weeks 4 and 12 .
METHODS	From the baseline OGTT results subjects were divided into three groups of low , median and high glucose tolerance .
RESULTS	At baseline , BMI , age and glycated hemoglobin concentrations were not different between subjects allocated to the high - or low-GI diets .
RESULTS	After four weeks , weight loss was 3.6 + / -0.3 kg .
RESULTS	Fasting glucose ( -5.6 % ) , glycated hemoglobin ( -2.8 % ) , area under the glucose curve ( -13.0 % ) and triglyceride ( -13.8 % ) concentrations were reduced ( p < 0.02 ) .
RESULTS	Between weeks 4 and 12 reductions were observed in weight ( -4.9 % ) , fasting glucose ( -4.6 % ) , area under glucose curve ( -10.1 % ) , glycated hemoglobin ( -7.2 % ) , triglyceride ( -7.5 % ) and LDL-C ( -13.2 % ) concentrations .
RESULTS	Weight loss was not different between low and high-GI diets .
RESULTS	However , glycated hemoglobin was reduced twofold more in subjects consuming a low-GI diet as compared to subjects consuming a high-GI diet , but this was not statistically significant .
RESULTS	LDL concentrations were also reduced more in subjects with low glucose tolerance on the low-GI diet ( p = 0.02 ) .
CONCLUSIONS	Weight loss produces substantial improvements in glycemic control and lipoprotein metabolism .
CONCLUSIONS	Lowering the glycemic index of high carbohydrate , low fat diets increases the fall in LDL cholesterol in subjects with type 2 diabetes with low glucose tolerance , but has little effect on glycemic control .

###21329626
OBJECTIVE	To compare the pharmacokinetic ( PK ) profiles and bioequivalence of the extended-release ( ER ) and immediate-release ( IR ) formulations of dexibuprofen ( DI ) in healthy Chinese volunteers after single dose and multiple doses .
METHODS	Zefen ( IR capsule , containing 150 mg DI , Suzhou No. 4 Pharmaceutical Factory , Jiangsu , China ) and ER capsule ( containing 225 mg DI , Tianjin Zhongtian Pharmaceutical Co. Ltd. , Tianjin , China ) .
METHODS	This was an open , randomized , two-period crossover study .
METHODS	Eligible subjects were healthy male Chinese volunteers .
METHODS	22 subjects were randomly assigned to receive a single 450 mg dose of the test or reference formulation on the first day .
METHODS	During the next 6 days , the test group received a multiple-dose of ER DI capsule ( 450 mg , b.i.d. ) and the reference group took a multiple-dose of IR DI capsule ( 300 mg , t.i.d. ) , respectively .
METHODS	Multiple blood samples were collected , and plasma concentrations of DI were analyzed using high performance liquid chromatography ( HPLC ) system .
METHODS	After a 9-day washout period , the subjects were administered the alternate formulation .
METHODS	Bioequivalence was concluded if the 90 % confidence interval ( CI ) for the ratio between test and reference was within accepted limits .
METHODS	Adverse events ( AEs ) were monitored and documented throughout the confinement in the clinic and washout phases of each study period .
RESULTS	21 subjects completed the single dose administration and 20 subjects were evaluable for the multiple doses PK parameters .
RESULTS	Single-dose Mean AUC0-t and AUC0-inf for ER formulation were 116.14 21.54 mgh/l and 117.60 22.27 mgh/l , and for IR formulation , were 107.25 23.48 mgh/l and 108.18 23.93 mgh/l , with the 90 % CI within the limits accepted for bioequivalence .
RESULTS	Mean Cmax for ER and IR formulations were 22.30 5.17 mg/l and 30.26 13.54 mg/l , respectively .
RESULTS	And median tmax for ER and IR formulations were 4.5 h and 2.0 h.
RESULTS	The retard quotient ( delta R ) for ER product was 1.9 0.93 , which indicated an intermediate extended release effect .
RESULTS	Multiple-dose Mean AUC0-24 for ER formulation was 217.93 41.07 mgh/l and for IR formulation was 199.33 37.32 mgh/l .
RESULTS	Other PK parameters of ER and IR formulations were as follows : median tmax were 4.8 h and 2.0 h , Css-max were 20.21 2.69 mg/l and 19.71 3.46 mg/l , Css-min were 2.47 0.99 mg/l and 2.48 0.99 mg/l , Cav were 9.08 1.71 mg/l and 8.31 1.56 mg/l , respectively .
CONCLUSIONS	This study found that in these subjects , the absorption rates of the two DI formulations were not bioequivalent , but at steady state , the daily exposure provided by less frequent DI ER dosing was not significantly different from the same daily dose with DI IR capsules , administered more frequently .

###25041994
BACKGROUND	Recurrence and toxicity occur commonly among patients with rectal cancer who are treated with 5-fluorouracil ( 5-FU ) .
BACKGROUND	The authors hypothesized that genetic variation in folate-metabolizing genes could play a role in interindividual variability .
BACKGROUND	The objective of the current study was to evaluate the associations between genetic variants in folate-metabolizing genes and clinical outcomes among patients with rectal cancer treated with 5-FU .
METHODS	The authors investigated 8 functionally significant polymorphisms in 6 genes ( methylenetetrahydrofolate reductase [ MTHFR ] [ C677T , A1298C ] , SLC19A1 [ G80A ] , SHMT1 [ C1420T ] , dihydrofolate reductase [ DHFR ] [ Del19bp ] , TS 1494del , and TSER ) involved in folate metabolism in 745 patients with TNM stage II or III rectal cancer enrolled in a phase 3 adjuvant clinical trial of 3 regimens of 5-FU and radiotherapy ( INT-0144 and SWOG 9304 ) .
RESULTS	There were no statistically significant associations noted between polymorphisms in any of the genes and overall survival , disease-free survival ( DFS ) , and toxicity in the overall analyses .
RESULTS	Nevertheless , there was a trend toward worse DFS among patients with the variant allele of MTHFR C677T compared with wild-type , particularly in treatment arm 2 , in which patients with the MTHFR C677T TT genotype had worse overall survival ( hazards ratio , 1.76 ; 95 % confidence interval , 1.06-2 .93 [ P = .03 ] ) and DFS ( hazards ratio , 1.84 ; 95 % confidence interval , 1.12-3 .03 [ P = .02 ] ) compared with those with homozygous wild-type .
RESULTS	In addition , there was a trend toward reduced hematological toxicity among patients with variants of SLC19A1 G80A in treatment arm 1 ( P for trend , .06 ) and reduced esophagitis/stomatitis noted among patients with variants of TSER in treatment arm 3 ( P for trend , .06 ) .
CONCLUSIONS	Genetic variability in folate-metabolizing enzymes was found to be associated only to a limited degree with clinical outcomes among patients with rectal cancer treated with 5-FU .

###21409548
OBJECTIVE	To evaluate long-term ( over 4years ) functional outcomes and quality of life of transobturator ( TOR ) and retropubic ( RPR ) routes in the cure of stress urinary incontinence ( SUI ) .
METHODS	Prospective , randomized multicentre study involving 88 women with SUI from March 2004 to May 2005 ( RPR group ( n = 42 ) , TOR group ( n = 46 ) ) .
METHODS	Long-term functional results and quality of life were evaluated using validated questionnaires and compared with those observed at the first year .
RESULTS	Eight patients ( 19 % ) in the RPR group and 9 patients ( 19.5 % ) in the TOR group were lost to follow-up ( NS ) .
RESULTS	The mean follow-up in the RPR and the TOR groups was 52.7 months and 53.1 months , respectively .
RESULTS	In intention to treat , the success rate at 4years was 64.3 % in the RPR group and 69.5 % in the TOR group ( NS ) .
RESULTS	At 4years , no significant differences in the IIQ scores were observed in either group compared to the preoperative scores with no difference between the groups ( RPR group : 32 vs. 14.9 ( NS ) , TOR group : 25.7 vs. 21.4 ( NS ) ) .
RESULTS	Compared to 1year UDIQ and IIQ scores , a decrease in quality of life was observed for both groups at 4years ( RPR group : 4.7 vs. 34 ( P < 0.0001 ) and 2.6 vs. 14.9 ( P < 0.001 ) , TOR group : 1.2 vs. 38.7 ( P < 0.0001 ) and 0 vs. 21.4 ( P < 0.0001 ) ) without difference between the groups .
CONCLUSIONS	This study shows similar relatively high long-term success rates for both the RPR and TOR procedures .
CONCLUSIONS	Patients should be informed about a possible time-dependent alteration in functional results .

###12435256
BACKGROUND	Hormone replacement therapy ( HRT ) and antioxidant vitamins are widely used for secondary prevention in postmenopausal women with coronary disease , but no clinical trials have demonstrated benefit to support their use .
OBJECTIVE	To determine whether HRT or antioxidant vitamin supplements , alone or in combination , influence the progression of coronary artery disease in postmenopausal women , as measured by serial quantitative coronary angiography .
METHODS	The Women 's Angiographic Vitamin and Estrogen ( WAVE ) Trial , a randomized , double-blind trial of 423 postmenopausal women with at least one 15 % to 75 % coronary stenosis at baseline coronary angiography .
METHODS	The trial was conducted from July 1997 to January 2002 in 7 clinical centers in the United States and Canada .
METHODS	Patients were randomly assigned in a 2 x 2 factorial design to receive either 0.625 mg/d of conjugated equine estrogen ( plus 2.5 mg/d of medroxyprogesterone acetate for women who had not had a hysterectomy ) , or matching placebo , and 400 IU of vitamin E twice daily plus 500 mg of vitamin C twice daily , or placebo .
METHODS	Annualized mean ( SD ) change in minimum lumen diameter ( MLD ) from baseline to concluding angiogram of all qualifying coronary lesions averaged for each patient .
METHODS	Patients with intercurrent death or myocardial infarction ( MI ) were imputed the worst rank of angiographic outcome .
RESULTS	The mean ( SD ) interval between angiograms was 2.8 ( 0.9 ) years .
RESULTS	Coronary progression , measured in mean ( SD ) change , worsened with HRT by 0.047 ( 0.15 ) mm/y and by 0.024 ( 0.15 ) mm/y with HRT placebo ( P = .17 ) ; and for antioxidant vitamins by 0.044 ( 0.15 ) mm/y and with vitamin placebo by 0.028 ( 0.15 ) mm/y ( P = .32 ) .
RESULTS	When patients with intercurrent death or MI were included , the primary outcome showed an increased risk for women in the active HRT group ( P = .045 ) , and suggested an increased risk in the active vitamin group ( P = .09 ) .
RESULTS	Fourteen patients died in the HRT group and 8 in the HRT placebo group ( hazard ratio [ HR ] , 1.8 ; 95 % confidence interval [ CI ] , 0.75-4 .3 ) , and 16 in the vitamin group and 6 in the vitamin placebo group ( HR , 2.8 ; 95 % CI , 1.1-7 .2 ) .
RESULTS	Death , nonfatal MI , or stroke occurred in 26 HRT patients vs 15 HRT controls ( HR , 1.9 ; 95 % CI , 0.97-3 .6 ) and in 26 vitamin patients and 18 vitamin controls ( HR , 1.5 ; 95 % CI , 0.80-2 .9 ) .
RESULTS	There was no interaction between the 2 treatment interventions .
CONCLUSIONS	In postmenopausal women with coronary disease , neither HRT nor antioxidant vitamin supplements provide cardiovascular benefit .
CONCLUSIONS	Instead , a potential for harm was suggested with each treatment .

###10593469
BACKGROUND	In the last few years infraclavicular plexus block has become a method of increasing interest .
BACKGROUND	However , this block has been associated with high complication incidences and without advantage in the quality of blockade over the axillary approach .
BACKGROUND	We prospectively studied 40 patients ( ASA I-III ) undergoing surgery of the forearm and hand , and investigated the performance of the lateral infraclavicular plexus block against an axillary paravascular block to evaluate the success rate as well as the extent and quality of blockade .
METHODS	Patients were randomized into two groups : group I ( lateral infraclavicular approach ; n = 20 ) and group A ( axillary approach ; n = 20 ) .
METHODS	The lateral infraclavicular approach is a technique with the coracoid process ( CP ) as landmark .
METHODS	Alone the sagittal plane , the needle is inserted until contact with the CP .
METHODS	The needle is then withdrawn 2-3 mm and reinserted directly under the CP , until it contacts the brachial plexus sheath .
METHODS	Plexus blockade was performed using 40 ml of mepivacaine 1 % .
METHODS	Quality of sensory and motor block was recorded selectively for each nerve distribution at close intervals for 6 h.
RESULTS	Successful block according to Vester-Andersen 's criteria was achieved in 100 % of group I and 85 % of group A.
RESULTS	In group I , a pronounced sensory and motor blockade of the musculocutaneous nerve was observed , while patients of group A had a weak block of this nerve .
RESULTS	In group I , an additional spectrum of nerves ( thoracodorsal , axillary and medial brachial cutaneous nerves ) was involved compared to group A.
RESULTS	There was no difference among groups in onset and duration of block .
CONCLUSIONS	Based on the safe landmark and feasibility of this procedure and the additional spectrum of nerve block achieved , the application of lateral infraclavicular technique has to be reconsidered in clinical practice .

###8363067
BACKGROUND	The purpose of this clinical trial was to compare the effects of different anesthetic and analgesic regimens on hemostatic function and postoperative arterial thrombotic complications .
METHODS	Ninety-five patients scheduled for elective lower extremity vascular reconstruction were randomized to receive either epidural anesthesia followed by epidural fentanyl ( RA ) or general anesthesia followed by intravenous morphine ( GA ) .
METHODS	Intraoperative and postoperative care were controlled by protocol using predetermined limits for heart rate , blood pressure , and other monitoring criteria .
METHODS	Data collection included serial physical examinations , electrocardiograms , and cardiac isoenzymes to detect arterial thrombosis ( defined as unstable angina , myocardial infarction , or vascular graft occlusion requiring reoperation ) .
METHODS	Fibrinogen , plasminogen activator inhibitor-1 ( PAI-1 ) , and D-dimer levels were measured preoperatively and at 24 and 72 h postoperatively .
RESULTS	Preoperative fibrinogen levels were similar in both groups , remained unchanged after 24 h , and increased equally ( 45 % ) in the first 72 h postoperatively .
RESULTS	PAI-1 levels in the GA group increased from 13.6 + / - 2.1 activity units ( AU ) / ml to 20.2 + / - 2.6 AU/ml at 24 h and returned to baseline at 72 h.
RESULTS	In contrast , PAI-1 levels in the RA group remained unchanged over time .
RESULTS	Twenty-two of 95 patients ( 23 % ) had postoperative arterial thrombosis , 17 of whom had received GA and 5 of whom , RA .
RESULTS	Preoperative PAI-1 levels were higher in patients who developed postoperative arterial thrombosis ( 20.5 + / - 3.6 AU/ml vs. 11.2 + / - 1.4 AU/ml ) .
RESULTS	Multiple logistic regression analysis indicated that GA and preoperative PAI-1 levels were predictive of postoperative arterial thrombotic complications .
CONCLUSIONS	Impaired fibrinolysis may be related causally to postoperative arterial thrombosis .
CONCLUSIONS	Because RA combined with epidural fentanyl analgesia appears to prevent postoperative inhibition of fibrinolysis , this form of perioperative management may decrease the risk of arterial thrombotic complications in patients undergoing lower extremity revascularization .

###9488244
OBJECTIVE	This study was conducted to assess the dose-response relationship of the new angiotensin II ( Ang II ) antagonist CS-866 on blood pressure and on endocrine parameters in hypertensive patients with an activated renin-angiotensin system .
METHODS	Following a four-way crossover protocol , two groups of eight patients with mild-to-moderate hypertension received a sodium-restricted diet ( 60 mmol daily ) and ingested single doses of 2.5 , 10 and 40 mg or 5 , 20 and 80 mg of CS-866 , respectively , or placebo .
METHODS	Twenty-four hour ambulatory blood pressure measurements , plasma renin activity ( PRA ) , Ang II and concentrations of RNH-6270 , the pharmacologically active metabolite of CS-866 , were monitored up to 24 h after medication .
RESULTS	CS-866 was well tolerated .
RESULTS	There was a significant decrease in 24 h diastolic blood pressure ( DBP ) at all doses of CS-866 above 5 mg .
RESULTS	Increasing doses of CS-866 from 2.5 to 10 mg and from 5 to 20 mg lowered the mean 24 h DBP and DBP AUC ( 0-24h ) values considerably more than increasing doses from 10 to 40 mg and from 20 to 80 mg , respectively .
RESULTS	The mean 24 h DBP was lowered by 6.9 and 8.4 mmHg after oral doses of 10 and 20 mg CS-866 , respectively , compared with placebo and by 8.9 mmHg after 80 mg CS-866 .
RESULTS	The drug increased PRA and Ang II concentrations in plasma , maximum concentrations of which occurred within 3 h post-dose .
RESULTS	The highest RNH-6270 concentrations were also found at the first post-dose measurement 3 h after administration of CS-866 .
CONCLUSIONS	The new Ang II receptor antagonist CS-866 is effective and well tolerated .
CONCLUSIONS	In salt-restricted hypertensive patients , CS-866 lowered blood pressure and increased PRA and Ang II concentrations at low doses .
CONCLUSIONS	A single oral dose of 10-20 mg CS-866 resulted in almost maximal effects .

###20471549
BACKGROUND	Consecutive sessions of transcranial direct current stimulation ( tDCS ) over the primary motor cortex ( M1 ) may be a suitable therapy to treat chronic pain , as it can modulate neural activities in the stimulated and interconnected regions .
OBJECTIVE	The present study investigated the analgesic effect of five consecutive days of anodal/sham tDCS using subjective ( visual analog scale [ VAS ] ) and objective ( cortical excitability measured by transcranial magnetic stimulation [ TMS ] ) measurements .
METHODS	Patients with therapy-resistant chronic pain syndromes ( trigeminal neuralgia , poststroke pain syndrome , back pain , fibromyalgia ) participated .
METHODS	As this clinical trial was an exploratory study , statistical analyses implemented exploratory methods .
METHODS	Twelve patients , who underwent both anodal and sham tDCS , were analyzed using a crossover design .
METHODS	An additional nine patients had only anodal or sham stimulation .
METHODS	tDCS was applied over the hand area of the M1 for 20 minutes , at 1mA for five consecutive days , using a randomized , double-blind design .
METHODS	Pain was assessed daily using a VAS rating for one month before , during , and one month post-stimulation .
METHODS	M1 excitability was determined using paired-pulse TMS .
RESULTS	Anodal tDCS led to a greater improvement in VAS ratings than sham tDCS , evident even three to four weeks post-treatment .
RESULTS	Decreased intracortical inhibition was demonstrated after anodal stimulation , indicating changes in cortico-cortical excitability .
RESULTS	No patient experienced severe adverse effects ; seven patients suffered from light headache after anodal and six after sham stimulation .
CONCLUSIONS	Results confirm that five daily sessions of tDCS over the hand area of the M1 can produce long-lasting pain relief in patients with chronic pain .

###12795460
BACKGROUND	It has been suggested that psychopathology in irritable bowel syndrome ( IBS ) patients is a function of patient status rather than of the disease .
BACKGROUND	Although there are many studies comparing IBS patients , IBS non-patients , and controls with each other , no previous study has recruited all three groups from a representative community sample and had all subjects diagnosed by a physician .
BACKGROUND	In the present study we aimed to compare psychological factors in IBS patients , IBS non-patients , and normal controls in a sample recruited from the population .
METHODS	Subjects aged 18-45 years were recruited from a random sample of the normal population .
METHODS	Seventeen ( 2 M and 15 F ) IBS patients were matched by sex and age with IBS non-patients and normals .
METHODS	Measures of personality traits , interpersonal distress , and temporary psychological distress were used .
METHODS	A physician diagnosed all 51 subjects in order to exclude possible gastrointestinal diagnoses other than IBS .
RESULTS	Controls often differed from IBS non-patients and patients on the personality , interpersonal , and psychological distress measures , while IBS non-patients and patients very rarely differed from each other .
RESULTS	All three groups were non-alexithymic .
CONCLUSIONS	The results indicate that there are psychopathological differences between normals and IBS persons ( patients and non-patients ) , but they could not confirm that psychopathology was a function of patient status .
CONCLUSIONS	Whether this psychopathology is a vulnerability factor for IBS , or a consequence of it , remains to be studied .

###24053892
OBJECTIVE	To determine the percentage of ranibizumab-treated patients with retinal vein occlusion ( RVO ) who had resolution of edema for at least 6 months after the last injection , along with factors and outcomes that correlate with resolution .
METHODS	Post hoc analysis of open-label clinical trial .
METHODS	Twenty patients with branch RVO ( BRVO ) and 20 with central RVO ( CRVO ) received ranibizumab monthly for 3 months and as needed for recurrent/persistent macular edema , no more frequently than every 2 months .
METHODS	Patients still requiring injections after month 40 received scatter and grid laser photocoagulation to try to reduce the need for injections .
METHODS	Main outcome measures included the percentage of patients who had resolution of edema , change in best-corrected visual acuity ( BCVA ) from baseline , and change in area of retinal nonperfusion in central subfields .
RESULTS	Nine patients with BRVO ( 45 % ) had edema resolution from injections alone after a mean of 20.2 months , 4 resolved after addition of laser , 4 were unresolved through 72 months , and 3 exited prior to resolution .
RESULTS	Five patients with CRVO ( 25 % ) resolved from injections alone after a mean of 14.0 months , 8 remained unresolved through 72 months despite addition of laser , and 7 exited prior to resolution .
RESULTS	For BRVO or CRVO , there was a negative correlation between posterior retinal nonperfusion area and BCVA at months 18 , 24 , and 36 ( P < .05 ) .
CONCLUSIONS	In patients with RVO , infrequent ranibizumab injections to control edema may not be sufficient to prevent progression of retinal nonperfusion , which may contribute to loss of visual gains .

###17966746
OBJECTIVE	Colorectal cancer is a common cancer in the Nordic countries and 50 % of the patients develop liver metastases .
OBJECTIVE	Liver resection may result in long term survival .
OBJECTIVE	Proper staging is therefore essential and CT is the standard imaging modality .
OBJECTIVE	We examined whether additional FDG-PET improves therapeutic management of patients with colorectal liver metastases .
METHODS	Fifty-four consecutive patients were enrolled .
METHODS	Each patient had a treatment plan made based on our standard evaluation .
METHODS	The patients then had a PET scan and the treatment plan was re-evaluated , taking these results into account .
RESULTS	In 76 % of the cases , PET did not change the treatment plan due to complete concordance with CT. .
RESULTS	In another 19 % of the cases , the plan was altered due to finding of more liver lesions by PET than by CT ( four patients ) , fewer or no liver lesions ( three patients ) , and extrahepatic lesions not visible on CT ( three patients ) .
RESULTS	In 5 % of the cases , non-concordance between PET and CT did not change the therapeutic plan .
CONCLUSIONS	Pre-treatment FDG-PET , used supplementary to CT , improved the treatment plan in one fifth of the patients with colorectal liver metastases .

###15009002
OBJECTIVE	Osteopenia and excess adiposity occur following treatment of childhood acute lymphoblastic leukaemia ( ALL ) and the use of cranial irradiation is thought to be a significant contributory factor .
OBJECTIVE	Hyperleptinaemia has also been demonstrated following cessation of treatment for childhood ALL .
OBJECTIVE	Therefore a prospective study was undertaken to evaluate serial changes in percentage bone mineral content ( BMC ) , adiposity and serum leptin concentrations during 2 years of treatment of children with ALL with chemotherapy but without cranial irradiation .
METHODS	Only patients treated using the MRC ALL 97/ALL 97 ( modified 99 ) protocols for childhood ALL were eligible for entry into the study .
METHODS	A total of 14 patients ( seven male , with a median age of 7.5 years ( range 3.4-16 .7 years ) were recruited .
METHODS	Serial dual energy X-ray absorptiometry ( DEXA ) scanning was undertaken at diagnosis and during two years of treatment .
METHODS	Serum leptin concentrations were determined at the same time as the scans .
RESULTS	Reductions in % BMC were observed at the hip and lumbar spine by 12 months ( P < 0.01 ) and remained low after 24 months of treatment .
RESULTS	Subanalysis of % BMC measurements at the hip demonstrated a greater reduction in % BMC at the trochanteric region compared to the femoral neck .
RESULTS	The percentage corrected fat mass increased from 6 months whereas the body mass index ( BMI ) standard deviation score ( SDS ) was increased after 24 months of treatment ( P < 0.05 ) .
RESULTS	Serum leptin concentrations increased following 24 months of therapy ( P < 0.05 ) .
CONCLUSIONS	Children treated for ALL with contemporary regimens have a predisposition to osteopenia , excess adiposity and hyperleptinaemia during treatment without cranial irradiation administration .
CONCLUSIONS	We speculate that in addition to glucocorticoid administration , leptin resistance may account in part for these observations .

###9059138
OBJECTIVE	To assess the efficacy and safety of sulphasalazine in reactive arthritis .
METHODS	Double blind placebo controlled trial of six months duration comparing sulphasalazine 2-3 g per day ( n = 37 ) with matching placebo ( n = 42 ) in adults with active reactive arthritis ( age 19-57 years , median 34 ) .
METHODS	Treatment response was evaluated once a month by changes in erythrocyte sedimentation rate ( ESR ) , pain , peripheral arthritis , tender iliosacral joints , entesopathy , extra-articular manifestations , and working ability .
RESULTS	15 patients in the sulphasalazine group and eight in the placebo group withdrew from the study prematurely .
RESULTS	Adverse events , primarily gastrointestinal , were the main reason for withdrawal in the actively treated group .
RESULTS	Intention-to-treat analyses showed significant improvements over time in both groups in ESR , pain , and number of swollen joints ( P < 0.01 ) .
RESULTS	Number of days on sick leave decreased significantly in the sulphasalazine group only ( P < 0.01 ) .
RESULTS	No significant differences between the two groups were present after six months .
RESULTS	Among the patients completing the trial according to protocol , persistent complete remission had occurred within two months in five ( 23 % ) of the actively treated , but in no placebo treated patients ( P = 0.013 ) .
CONCLUSIONS	Sulphasalazine seemed to improve only the very short term outcome of reactive arthritis .
CONCLUSIONS	The possible beneficial effect of the drug should also be weighed against the risk of adverse events .
CONCLUSIONS	Although these were mainly mild , almost 25 % of the patients in the actively treated group gave up treatment for this reason .

###21993878
BACKGROUND	Individuals learn associations between alcohol 's sensory properties and intoxication , with such conditioned stimuli ( CS ) becoming involved in craving and relapse .
BACKGROUND	However , these CS also carry idiosyncratic associations .
OBJECTIVE	This study aimed to test brain responses to novel CS conditioned with alcohol intoxication .
METHODS	Fourteen heavy drinkers ( age 24.93.2 ) performed a reaction time task with embedded novel geometric CS and were told only that the task was to measure alcohol 's effect on speed .
METHODS	Rapid intravenous alcohol infusion ( the unconditioned stimulus ; UCS ) began with the appearance of a CS + , using pharmacokinetic modeling to increment breath alcohol by ~ 18mg % in 200s per each of six CS-UCS pairings .
METHODS	Placebo-saline infusion with CS - used the same infusion parameters in same-day randomized/counterbalanced sessions .
METHODS	The next morning subjects , connected to inactive intravenous pumps , underwent functional magnetic resonance imaging ( fMRI ) of the same task with mixed brief presentations of CS + , CS - , and irrelevant CS and were told that alcohol could be infused at any time during imaging .
RESULTS	CS - responses were significantly greater than those of CS + in medial frontal cortex .
RESULTS	Notably , CS + responses were negative , suggesting reduced neural activity .
RESULTS	Negative activity was most pronounced in early scans , extinguishing with time .
RESULTS	As subjects were told that alcohol could be administered in fMRI , a CS + without alcohol is similar to a negative prediction error , with associated reduced frontal activity during withheld reward .
CONCLUSIONS	Novel stimuli relatively free of demand characteristics can be classically conditioned to intermittent brain exposure of even low alcohol concentrations , permitting imaging studies of conditioned alcohol expectancies .

###23893503
BACKGROUND	We examined the effects of home-delivered cognitive-behavior therapy ( CBT ) on depressive symptoms among rural , diverse , and vulnerable older adults .
BACKGROUND	Furthermore , we differentiated depression into its two salient aspects : psychological and somatic .
METHODS	Data came from a randomized controlled experiment of CBT on 134 individuals residing in rural Alabama .
RESULTS	Cognitive-behavior therapy resulted in significantly lower depressive symptom severity scores .
RESULTS	When depressive symptoms were categorized as psychological or somatic , CBT was found to significantly improve the former but not the latter .
RESULTS	Notably , there was a trend toward somatic symptom improvement .
CONCLUSIONS	Cognitive-behavior therapy can be an effective treatment for depression in a hard-to-reach group of older adults .
CONCLUSIONS	Home delivery affords advantages but is also an expensive delivery modality .
CONCLUSIONS	Diverse older adults responded to the CBT intervention .

###15188980
OBJECTIVE	To assess the effectiveness of expressed breast milk ( EBM ) in reducing pain due to venepuncture , in term neonates , as measured by behavioural and physiological observations .
METHODS	This randomized , placebo-controlled , double-blind trial involved 81 full-term neonates , up to 4 wk of postnatal age , who needed venepuncture for blood investigations .
METHODS	Two minutes before the venepuncture , in the intervention arm , 40 babies received 5 ml of EBM , while 41 babies in control group received 5 ml of distilled water ( DW ) as placebo .
METHODS	Two observers who were blinded to the intervention recorded the physiological ( heart rate and oxygen saturation ) and behavioural parameters [ duration of crying and modified Neonatal Facial Coding Scores ( NFCS ) ] after the venepuncture .
RESULTS	There was no difference in the baseline characteristics of the neonates in the two groups .
RESULTS	The duration of crying was significantly shorter in babies fed EBM [ median 38.5 s , interquartile range ( IQR ) 9.5-57 .5 s ] than in those fed DW ( median 90 s , IQR 28-210 s ) .
RESULTS	The mean duration of crying in EBM group was shorter by 70.7 ( 95 % confidence interval 36.6-104 .9 ) s.
RESULTS	The modified NFCS at 0 , 1 and 3 min was significantly lower ( p < 0.01 ) in the EBM than in the DW group .
RESULTS	The change in heart rate and oxygen saturation was significantly lower in the EBM group and returned to baseline values sooner than in the DW group .
CONCLUSIONS	Feeding 5 ml of EBM before venepuncture is effective in reducing symptoms due to pain in term neonates .

###11128859
OBJECTIVE	The purpose of this investigation was 1 ) to determine whether HMB supplementation results in an increase in strength and FFM during 8 wk of resistance training and 2 ) determine whether a higher dose of HMB provides additional benefits .
METHODS	Thirty-seven , untrained , college-aged men were assigned to one of three groups : 0 , 38 , or 76 mg x kg ( -1 ) x d ( -1 ) of HMB ( approximately equal to 3 and 6 g x d ( -1 ) , respectively ) .
METHODS	Resistance training consisted of 10 different exercises performed 3 d x wk ( -1 ) for 8 wk at 80 % of 1-repetition maximum ( 1RM ) .
METHODS	The 1RM was reevaluated every 2 wk with workloads adjusted accordingly .
RESULTS	No differences were observed in 1RM strength among the groups at any time .
RESULTS	However , the 38 mg x kg ( -1 ) x d ( -1 ) group showed a greater increase in peak isometric torque than the 0 or 76 mg.kg ( -1 ) x d ( -1 ) groups ( P < 0.05 ) .
RESULTS	The 76 mg x kg ( -1 ) x d ( -1 ) group had a greater increase in peak isokinetic torque than the 0 or 38 mg x kg ( -1 ) x d ( -1 ) groups at 2.1 , -3.15 , and -4.2 rad x s ( -1 ) ( P < 0.05 ) .
RESULTS	Plasma creatine phosphokinase ( CPK ) activity was greater for the 0 mg x kg ( -1 ) x d ( -1 ) versus the 38 or 76 mg x kg ( -1 ) x d ( -1 ) groups at 48 h after the initial training bout ( P < 0.05 ) .
RESULTS	In addition , no differences were observed in body fat between the three groups .
RESULTS	However , the 38 mg x kg ( -1 ) x d ( -1 ) group exhibited a greater increase in FFM ( P < 0.05 ) .
CONCLUSIONS	Although the IRM strength gains were not significantly different , HMB supplementation appears to increase peak isometric and various isokinetic torque values , and increase FFM and decrease plasma CPK activity .
CONCLUSIONS	Lastly , it appears that higher doses of HMB ( i.e. , > 38 mg x kg ( -1 ) x d ( -1 ) ) do not promote strength or FFM gains .

###20235836
BACKGROUND	Herpes simplex virus ( HSV ) suppressive therapy reduces genital and plasma human immunodeficiency virus type 1 ( HIV-1 ) RNA over periods up to 3 months , but the long-term effect is unknown .
METHODS	A total of 484 HIV-1 and HSV type 2 seropositive Tanzanian women aged 16-35 years were enrolled in a randomized placebo-controlled trial of acyclovir administered at a dosage of 400 mg twice daily .
METHODS	Cervico-vaginal lavage and blood samples were collected at 6 months , 12 months , and 24 months for quantification of genital and plasma HIV-1 RNA and genital HSV DNA .
METHODS	Primary outcomes were detection and quantity of cervico-vaginal HIV-1 RNA at 6 months .
RESULTS	At 6 months , there was little difference between the acyclovir and placebo arms for cervico-vaginal HIV-1 RNA detection ( 88 [ 41 .3 % ] of 213 vs 84 [ 44 .0 % ] of 191 ; odds ratio [ OR ] , 0.90 ; 95 % confidence interval [ CI ] , 0.60-1 .33 ) , HSV DNA detection ( 20 [ 9 .4 % ] of 213 vs 22 [ 11 .5 % ] of 191 ; OR , 0.80 ; 95 % CI , 0.42-1 .51 ) , genital HIV or HSV loads , or plasma HIV-1 RNA load .
RESULTS	Estimated median adherence was 91 % .
RESULTS	There was a suggestion of an impact on cervico-vaginal HIV-1 RNA detection among women with estimated adherence 90 % ( OR , 0.74 ; 95 % CI , 0.50-1 .09 ) when data from all 3 visits were included .
CONCLUSIONS	Acyclovir administered at a dosage of 400 mg twice daily is unlikely to be a useful long-term intervention to reduce HIV transmission .
CONCLUSIONS	The lack of effect on HIV may be attributable to suboptimal adherence or treatment regimen .

###18285431
OBJECTIVE	This pilot randomized controlled trial evaluated an assistant-led , community-based intervention to improve community mobility and participation after stroke , and examined the potential for independent community ambulation in people with subacute stroke who present with moderate gait deficit .
METHODS	A multicentre , pilot randomized controlled trial .
METHODS	Three hospitals and three community settings in New Zealand .
METHODS	Thirty post-acute , home-dwelling stroke survivors were randomly allocated to receive intervention in the community ( n = 14 ) or as hospital outpatients ( n = 16 ) twice a week for seven weeks .
METHODS	The community intervention involved practice of functional gait activities in community environments relevant to each participant .
METHODS	Hospital-based physiotherapy was based upon a Motor Relearning approach .
METHODS	The primary outcome measure was gait speed ( m/min ) .
METHODS	Secondary outcomes included endurance ( six-minute walk time ) , Activities-specific Confidence Balance Scale , and the Subjective Index of Physical and Social Outcomes measured at baseline , post intervention and six months .
RESULTS	Large gains in gait speed were obtained for participants in both groups : community group mean ( SD ) 16 ( 16.1 ) m/min ; physiotherapy group mean ( SD ) 15.9 ( 16.1 ) m/min , maintained at six months .
RESULTS	There were no significant differences between groups for primary and secondary outcomes after treatment ( P = 0.86 ANOVA ) or at six months ( P = 0.83 ANOVA ) .
RESULTS	Only 11 participants reported independent community ambulation .
RESULTS	Levels of social integration were low to moderate .
CONCLUSIONS	A community-based gait recovery programme appears a practicable alternative to routine physiotherapy , however independent community ambulation is a challenging rehabilitation goal .

###19083719
OBJECTIVE	To examine the effects of a plyometric program on peak vertical ground reaction force as well as kinetic jumping characteristics in recreationally athletic college women .
METHODS	Six week prospective exercise intervention .
METHODS	Division I university campus .
METHODS	Twenty college females who competed recreationally in basketball were randomly assigned to a training ( n = 10 ) or control ( n = 10 ) group .
METHODS	The absolute change values for vertical ground reaction force , countermovement jump height , peak and average jump power , and peak jump velocity .
METHODS	Comparisons were made using Mann-Whitney U tests .
RESULTS	Vertical ground reaction force decreased in the intervention group ( -222.8 + / -610.9 N ) , but was not statistically different ( p = 0.122 ) compared to the change observed in the control group ( 54.6 + / -257.6 N ) .
RESULTS	There was no difference in the absolute change values between groups for countermovement jump height ( 1.0 + / -2.8 cm vs. -0.2 + / -1.5 cm , p = 0.696 ) or any of the associated kinetic variables following the 6-week intervention .
CONCLUSIONS	Although not statistically significant , the mean absolute reduction in vertical ground reaction force in the training group is clinically meaningful .
CONCLUSIONS	Eight of the 10 women in the training group reduced vertical ground reaction force by 17-18 % ; however , improvements in jumping performance were not observed .
CONCLUSIONS	This indicates that programs aimed at enhancing performance must be designed differently from those aimed at reducing landing forces in recreationally athletic women .

###24658148
OBJECTIVE	This study aims to determine the outcome of double-bundle anterior cruciate ligament ( ACL ) reconstruction using an allograft in comparison with ACL reconstruction using a double-bundle autograft or a single-bundle allograft .
METHODS	A total of 424 patients who accepted primary ACL reconstructions were divided randomly into three groups : double-bundle technique with autograft ( DB-AU group , n = 154 ) , double-bundle technique with allograft ( DB-AL group , n = 128 ) , and single-bundle technique with allograft ( SB group , n = 142 ) .
METHODS	The KT-1000 arthrometer and pivot-shift tests were performed at 3 , 12 , and 36 months after surgery , and clinical outcome measurements include the Lysholm score and the IKDC rating scales .
METHODS	Radiological assessments evaluated arthritic changes and tunnel expansion at 36 months postoperatively .
RESULTS	The KT-1000 test scores in the DB-AU and DB-AL groups were significantly better than those in the SB group at 12 and 36 months postoperatively ( P < 0.05 ) .
RESULTS	The pivot-shift tests scores in the DB-AU and DB-AL groups were significantly better than those in the SB group at the 3 , 12 , and 36 month follow-ups ( P < 0.05 ) .
RESULTS	Based on the IKDC score and Lysholm score , there were no significant difference between the three groups during follow-up ( P > 0.05 ) .
RESULTS	At 36 months postoperatively , 42.3 % of patients in the SB group showed a progression in arthritic changes , which was greater than in the DB-AU ( 29.2 % ) and DB-AL ( 27.3 % ) groups ( P < 0.05 ) .
RESULTS	At 36 months , the rates of tunnel expansion in the DB-AU group and the DB-AL group were lower than in the SB group ( P < 0.05 ) .
CONCLUSIONS	Double-bundle ACL reconstruction can be used to achieve better anterior and rotational stability and has a lower rate of arthritic progression and tunnel expansion than the single-bundle procedure .
METHODS	I.

###11587610
OBJECTIVE	To determine if preemptive analgesia with ropivacaine hydrochloride with or without clonidine hydrochloride decreases pain and hastens recovery after tonsillectomy .
METHODS	Prospective , randomized , triple-blinded trial .
METHODS	University referral center ; pediatric ambulatory practice .
METHODS	Sixty-four children , aged 3 to 15 years , undergoing tonsillectomy .
METHODS	Patients received injections in the tonsillar fossae of isotonic sodium chloride , ropivacaine , or ropivacaine plus clonidine prior to tonsil excision .
METHODS	Visual analogue ( pain ) scale scores at rest and when drinking , opioid use , recovery time to normal activity , and incidence of symptoms such as otalgia .
RESULTS	Pain was reduced on postoperative day 0 in the ropivacaine-treated and ropivacaine plus clonidine-treated groups as compared with the isotonic sodium chloride-treated group ( P < .05 ) .
RESULTS	Pain was also decreased in the ropivacaine plus clonidine-treated group on postoperative days 3 and 5 ( P < .05 ) .
RESULTS	Intravenous narcotic use was decreased on day 0 in the ropivacaine-treated and ropivacaine plus clonidine-treated groups ( P < .05 ) .
RESULTS	Cumulative codeine use was similar at day 3 for all patients , but was decreased at day 5 in the ropivacaine plus clonidine-treated group ( P < .05 ) .
RESULTS	The incidence of otalgia decreased from 89 % ( 16/18 ) in the isotonic sodium chloride-treated group to 63 % ( 12/19 ) in the ropivacaine-treated and 61 % ( 11/18 ) in the ropivacaine plus clonidine-treated groups ( P < .01 ) .
RESULTS	Recovery to normal activity was shortened from 8.1 + / - 1.6 days to 5.8 + / - 2.9 days ( mean + / - SD ) in the isotonic sodium chloride-treated and ropivacaine plus clonidine-treated groups , respectively ( P = .03 ) .
CONCLUSIONS	Preincisional injection of ropivacaine with clonidine prior to tonsillectomy has a preemptive analgesic effect that outlasts the local anesthetic and decreases pain , opioid use , and the time to return to normal activity .

###22228638
OBJECTIVE	Signaling pathway stimulation by activating mutations of oncogenes occurs in most melanomas and can provide excellent targets for therapy , but the short-term therapeutic success is limited by intrinsic and acquired resistance .
OBJECTIVE	The mitogen-activated protein kinase and phosphoinositide 3-kinase/AKT/mTOR pathways are activated in most cutaneous melanomas .
OBJECTIVE	The purpose of this trial was to prospectively evaluate 2 molecularly targeted drug combinations in patients with untreated metastatic melanoma .
METHODS	This randomized phase II study enrolled patients between May 2008 and November 2009 with nonocular melanoma , no prior systemic chemotherapy , and no history of brain metastasis .
METHODS	Arm A received oral sorafenib 200 mg twice daily plus i.v. temsirolimus 25 mg weekly ; and arm B received oral sorafenib 400 mg every morning , 200 mg every night daily plus oral tipifarnib 100 mg twice daily , 3 weeks of every 4 .
METHODS	The primary objectives were to evaluate progression-free survival ( PFS ) , objective response rate , and toxicity for the 2 regimens .
RESULTS	On arm A ( 63 evaluable patients ) , the median PFS was 2.1 months and median overall survival ( OS ) was 7 months .
RESULTS	Three patients achieved partial response ( PR ) .
RESULTS	Thirty-nine evaluable patients were accrued to arm B , which closed after first-stage accrual ; the median PFS was 1.8 months and OS was 7 months , with 1 patient achieving PR .
CONCLUSIONS	The combinations of molecularly targeted agents tested did not show sufficient activity to justify further use .
CONCLUSIONS	Newer agents and improved patient selection by characterization of the molecular targets in individual tumors show great promise and should be incorporated into future studies , along with appropriate laboratory correlates .

###9425972
OBJECTIVE	Local anesthetics block propagation in nerve fibers but may also inhibit inflammation .
OBJECTIVE	Inflammatory phenomena such as warmth , reddening , and swelling are intimately connected with blood flow .
OBJECTIVE	Our primary aim was to investigate the effect of mepivacaine on cutaneous blood flow in a situation involving hyperemia , but no inflammation , namely , after arterial occlusion .
METHODS	The subjects were healthy volunteers ( 9 men , 7 women ) .
METHODS	Pain was evaluated by visual analog scale every 5 minutes .
METHODS	A laser Doppler probe was applied on each forearm .
METHODS	After baseline flow measurements during 30 minutes , a bilateral regional intravenous block ( Bier block ) was performed by injecting mepivacaine ( 1.4 mg/kg in 40 mL ) in one arm and normal saline in the other in a randomized , controlled , double-blind manner .
METHODS	Arterial occlusion was maintained for 20 minutes , and flow was followed for 60 minutes after release of the block .
RESULTS	The ischemic pain , though modest , was less ( P = .045 ) in the treated arm .
RESULTS	Following release of the cuff , the blood flow had essentially stabilized after 20 minutes .
RESULTS	The reactive hyperemia ( 1-20 minutes ) was attenuated in the mepivacaine-treated arm ( mean , 68 % of placebo , P = .025 ) .
RESULTS	In the 21-60-minute period , flow in this arm stabilized at a lower level ( mean , 73 % of placebo , P = .0013 ) .
CONCLUSIONS	Mepivacaine is a vasoconstrictor of long duration .
CONCLUSIONS	This has to be taken into account when antiinflammatory effects of mepivacaine are assessed .

###23802920
OBJECTIVE	To investigate the effects of short-term , reduced-volume sprint interval training ( SIT ) compared to traditional exercise recommendations ( TER ) in sedentary obese men .
METHODS	Sixteen subjects [ 37.85.8 years ; body mass index ( BMI ) 32.84.7 kg/m ( 2 ) ] were randomly allocated to 2weeks of either SIT ( 6 sessions of 8-1210s sprints ) or TER [ 10 sessions of 30min at 65 % peak oxygen consumption ( VO ( 2peak ) ) ] cycle exercise .
METHODS	Fasting plasma glucose , insulin , non-esterified fatty acids ( NEFA ) , homeostasis model assessment of insulin sensitivity ( HOMA-IR ) , body composition and VO ( 2peak ) were assessed at baseline and approximately 72h after the final training bout .
METHODS	Skeletal muscle biopsy samples were also obtained before and 72h after training and analysed for AS160 phosphorylation and COX II , COX IV , GLUT-4 , Nur77 and SIRT1 protein expression .
RESULTS	No changes in BMI , body composition , VO ( 2peak ) , glucose , insulin , NEFA and HOMA-IR were observed after training , either within or between groups .
RESULTS	Skeletal muscle markers of glucose metabolism and mitochondrial function also remained unaltered after 2weeks of exercise training .
CONCLUSIONS	Our findings show that 2weeks of reduced-volume SIT or TER did not elicit any measurable metabolic adaptations in sedentary obese men .
CONCLUSIONS	Further work is needed to determine the minimal amount of exercise required for short-term adaptations in this population .

###18837860
OBJECTIVE	A post hoc analysis of pooled data from two quetiapine monotherapy clinical trials was conducted to evaluate the efficacy and tolerability of quetiapine therapy ( twice daily , 400-800 mg/day ) among bipolar manic adults aged 55 years and older .
OBJECTIVE	The primary efficacy endpoint was the change from baseline in Young Mania Rating Scale ( YMRS ) total score at Day 21 .
OBJECTIVE	A secondary endpoint was change from baseline in YMRS score at Day 84 .
METHODS	A total of 407 patients made up the safety population , consisting of 59 older adults ( aged > or = 55 years ) and 348 younger adults .
METHODS	A total of 403 patients made up the efficacy population , consisting of 59 older adults and 344 younger adults .
METHODS	Efficacy outcomes were analyzed using covariance models ( ANCOVA ) ; descriptive statistics are presented for safety outcomes .
RESULTS	Both older and younger individuals treated with quetiapine had significant improvement from baseline on YMRS scores compared with placebo-treated patients .
RESULTS	The older adult group demonstrated a sustained reduction in YMRS score compared with placebo that was apparent by Day 4 of treatment .
RESULTS	For the quetiapine treatment groups , the most common adverse effects ( at a frequency > or = 10 % ) were dry mouth , somnolence , postural hypotension , insomnia , weight gain , and dizziness in older adults , and dry mouth , somnolence , and insomnia in younger adults .
RESULTS	For the placebo treatment groups , insomnia was the most common adverse event in both older and younger adults .
CONCLUSIONS	This secondary analysis suggests that quetiapine represents a potentially useful treatment option among older adults with bipolar I mania .
CONCLUSIONS	Studies with a primary focus of geriatric bipolar mania , and including larger patient numbers , are needed to confirm these findings .

###17353079
BACKGROUND	Pulse oximetry is the most common technique to monitor oxygen saturation ( SpO ( 2 ) ) during intensive care therapy .
BACKGROUND	However , intermittent co-oximetry is still the `` gold standard '' ( SaO ( 2 ) ) .
BACKGROUND	Besides acrylic nails , numerous other factors have been reported to interfere with pulse oximetry .
BACKGROUND	Data of measurements with artificial finger nails are not sufficiently published .
METHODS	A prospective clinical-experimental trial in mechanically ventilated and critically ill patients of an ICU was performed .
METHODS	Patients were randomly assigned to either group S ( S : Siemens pulse oximeter ) or group P ( P : Philips pulse oximeter ) prior to the measurements .
METHODS	SpO ( 2 ) was determined in each patient three times alternately in standard ( ( N ) SpO ( 2 ) ) and sideways position at the natural nail ( ( N90 ) SpO ( 2 ) ) .
METHODS	For the reference measurements oxygen saturation was measured by means of a haemoximeter ( co-oximetry ) .
METHODS	Thereafter , SpO ( 2 ) was obtained at the acrylic finger nail in the same way ( ( A ) SpO ( 2 ) and ( A90 ) SpO ( 2 ) ) .
METHODS	Bias was calculated as DeltaS = ( N ) SpO ( 2 ) - SaO ( 2 ) and DeltaS = ( A ) SpO ( 2 ) - SaO ( 2 ) .
METHODS	Accuracy ( mean difference ) and precision ( standard deviation ) were used to determine the measurement discrepancy .
METHODS	P < 0.05 was considered significant .
RESULTS	Accuracy and precision without acrylic nails applied were comparable to SaO ( 2 ) in both groups ( n.s. ) .
RESULTS	With acrylic nails applied a bias of DeltaS = -1.1 + / -3.14 % for group S ( P = 0.00522 ) and a bias of DeltaS = +0.8 + / -3.04 % for group P was calculated ( n.s. ) .
CONCLUSIONS	Acrylic finger nails may impair the measurement of oxygen saturation depending on the pulse oximeter used and may cause significant inaccuracy .
CONCLUSIONS	Hence , removal of artificial acrylic finger nails may be helpful to assure an accurate and precise measurement with pulse oximetry .

###20567019
OBJECTIVE	Liver dissemination is a major cause of mortality among patients with advanced colorectal cancer .
OBJECTIVE	Hepatic intra-arterial injection of the beta-emitting isotope yttrium-90 ( ( 90 ) Y ) bound to resin microspheres ( radioembolization ) delivers therapeutic radiation doses to liver metastases with minimal damage to adjacent tissues .
METHODS	We conducted a prospective , multicenter , randomized phase III trial in patients with unresectable , chemotherapy-refractory liver-limited metastatic CRC ( mCRC ) comparing arm A ( fluorouracil [ FU ] protracted intravenous infusion 300 mg/m ( 2 ) days 1 through 14 every 3 weeks ) and arm B ( radioembolization plus intravenous FU 225 mg/m ( 2 ) days 1 through 14 then 300 mg/m ( 2 ) days 1 through 14 every 3 weeks ) until hepatic progression .
METHODS	The primary end point was time to liver progression ( TTLP ) .
METHODS	Cross-over to radioembolization was permitted after progression in arm A.
RESULTS	Forty-six patients were randomly assigned and 44 were eligible for analysis ( arm A , n = 23 ; arm B , n = 21 ) .
RESULTS	Median follow-up was 24.8 months .
RESULTS	Median TTLP was 2.1 and 5.5 months in arms A and B , respectively ( hazard ratio [ HR ] = 0.38 ; 95 % CI , 0.20 to 0.72 ; P = .003 ) .
RESULTS	Median time to tumor progression ( TTP ) was 2.1 and 4.5 months , respectively ( HR = 0.51 ; 95 % CI , 0.28 to 0.94 ; P = .03 ) .
RESULTS	Grade 3 or 4 toxicities were recorded in six patients after FU monotherapy and in one patient after radioembolization plus FU treatment ( P = .10 ) .
RESULTS	Twenty-five of 44 patients received further treatment after progression , including 10 patients in arm A who received radioembolization .
RESULTS	Median overall survival was 7.3 and 10.0 months in arms A and B , respectively ( HR = 0.92 ; 95 % CI , 0.47 to 1.78 ; P = .80 ) .
CONCLUSIONS	Radioembolization with ( 90 ) Y-resin microspheres plus FU is well tolerated and significantly improves TTLP and TTP compared with FU alone .
CONCLUSIONS	This procedure is a valid therapeutic option for chemotherapy-refractory liver-limited mCRC .

###12121799
BACKGROUND	There is increasing interest in developing interventions to promote physical activity ( PA ) that do not involve face-to-face contact with health professionals .
BACKGROUND	We developed a fully automated PA counseling system ( telephone-linked communication , TLC-PA ) that was delivered via telephone .
METHODS	A randomized , controlled trial with 298 adult , sedentary members ( mean age , 45.9 years ; 72 % women ; 45 % white ; and 45 % African American ) of a multi-site medical practice .
METHODS	The comparison group ( TLC-Eat ) received an automated intervention promoting healthy eating , which was also delivered via telephone .
METHODS	The TLC-PA promoted moderate-intensity PA ( MI-PA ) based on the transtheoretical model of behavior change and social cognitive theory .
METHODS	The system was available to participants for 6 months .
RESULTS	Energy expenditure in MI-PA , proportion of participants who met recommendations for MI-PA , and motivational readiness for PA. .
METHODS	Self-reports of PA behavior and motivational readiness at baseline , 3 months , and 6 months .
RESULTS	At 3 months , intention-to-treat analyses showed that the TLC-PA group was more likely to meet recommendations for MI - or vigorous-intensity PA ( VI-PA ) compared to the TLC-Eat group ( TLC-PA = 26 % vs TLC-Eat = 19.6 % , p = 0.04 ) .
RESULTS	Among study completers , TLC-PA subjects reported significantly higher daily kilocalorie energy expenditure in MI-PA ( 2.3 kcal/kg/d vs 2.0 kcal/kg/d , p = 0.02 ) ; a larger proportion met recommendations for MI - or VI-PA ( 31.2 % vs 21.3 % , p = 0.02 ) and were in more advanced stages of motivational readiness than TLC-Eat subjects ( TLC-PA = 52.5 % vs TLC-Eat = 42.2 % , p = 0.04 ) .
RESULTS	Results were not maintained at 6 months .
RESULTS	The proportion of TLC-PA users decreased significantly over the intervention period .
CONCLUSIONS	A fully automated counseling system had positive short-term effects on PA among sedentary adults .
CONCLUSIONS	Lack of maintenance of effects may be due to a decrease in the number of participants who continued to use the system .

###21605396
BACKGROUND	The inhaled corticosteroid ( ICS ) fluticasone propionate ( fluticasone ) and the long-acting 2-agonist ( LABA ) formoterol fumarate ( formoterol ) are being made available as a combination product ( fluticasone/formoterol , flutiform ) in a single aerosol inhaler .
BACKGROUND	This 12-week , open-label , randomized , active-controlled , parallel-group , multicentre , phase 3 study compared the efficacy and safety of fluticasone/formoterol with the commercially available combination product fluticasone/salmeterol .
METHODS	Patients aged 18 years ( N = 202 ) with mild-to-moderate-severe , persistent asthma for 6 months prior to screening were included in the study .
METHODS	After a screening phase ( 4-10 days ) , eligible patients were randomized 1:1 to receive fluticasone/formoterol or fluticasone/salmeterol during the 12-week treatment period .
METHODS	The primary objective was to demonstrate non-inferiority of fluticasone/formoterol versus fluticasone/salmeterol , measured by pre-dose forced expiratory volume in the first second ( FEV1 ) , at week 12 .
RESULTS	Fluticasone/formoterol was comparable to fluticasone/salmeterol for the primary efficacy endpoint , mean pre-dose FEV1 at week 12 .
RESULTS	The new combination was also comparable to fluticasone/salmeterol for change from baseline to week 12 in pre-dose FEV1 , change from pre-dose FEV1 at baseline to 2-hour post-dose FEV1 at week 12 and discontinuations due to lack of efficacy .
RESULTS	Importantly , fluticasone/formoterol was superior to fluticasone/salmeterol in time to onset of action throughout the duration of the study .
RESULTS	The two treatments demonstrated similar results for various other secondary efficacy parameters , including other lung function tests , patient-reported outcomes , rescue medication use , asthma exacerbations and Asthma Quality of Life Questionnaire scores .
RESULTS	Fluticasone/formoterol was well tolerated and had a good safety profile that was similar to fluticasone/salmeterol .
CONCLUSIONS	The results of this study indicate that fluticasone/formoterol is as effective as fluticasone/salmeterol , and has a more rapid onset of action , reflecting the faster bronchodilatory effects of formoterol compared with those of salmeterol .
CONCLUSIONS	If patients perceive the benefits of therapy with fluticasone/formoterol more rapidly than with fluticasone/salmeterol , this could have a positive impact on preference and adherence .

###14633754
BACKGROUND	As continuous wound instillation with local anaesthetic has not been evaluated after hip/knee arthroplasties , our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after joint replacement surgery .
METHODS	Thirty-seven patients undergoing elective hip/knee arthroplasties under spinal block were randomly assigned to two analgesia groups .
METHODS	Group M received continuous i.v. infusion of morphine plus ketorolac for 24 h. Then , a multi-hole 16 G catheter was placed subcutaneously and infusion of saline was maintained for 55 h. Group R received i.v. saline .
METHODS	Thereafter the wound was infiltrated with a solution of ropivacaine 0.5 % 40 ml , then a multi-hole 16 G catheter was placed subcutaneously and an infusion of ropivacaine 0.2 % 5 ml h ( -1 ) was maintained for 55 h. Visual analogue scale scores were assessed at rest and on passive mobilization by nurses blinded to analgesic treatment .
METHODS	Total plasma ropivacaine concentration was measured .
RESULTS	Group R showed a significant reduction in postoperative pain at rest and on mobilization , while rescue medication requirements were greater in Group M. Total ropivacaine plasma concentration remained below toxic concentrations and no adverse effects occurred .
RESULTS	Length of hospital stay was shorter in Group R.
CONCLUSIONS	Infiltration and wound instillation with ropivacaine 0.2 % is more effective in controlling postoperative pain than systemic analgesia after major joint replacement surgery .

###17828786
OBJECTIVE	Studies have shown cognitive problems in adults treated with anticholinergics .
OBJECTIVE	It is unclear if children are also susceptible to anticholinergic adverse effects .
OBJECTIVE	This study evaluates the effects of long-acting oxybutynin and tolterodine on short-term memory and attention in children with urgency and urge incontinence .
METHODS	Children with urgency or urge incontinence were recruited to take part in a prospective , randomized double-blinded placebo controlled trial using long-acting oxybutynin or tolterodine .
METHODS	Patients underwent a baseline test of their memory/recall ability and attention span using a standardized developmental/neuropsychological assessment tool .
METHODS	They were then randomized to either medication or placebo with retesting in 2 weeks , at which time they were crossed .
METHODS	They were retested after the second 2 weeks .
RESULTS	Fourteen children ( 9 boys and 5 girls ) , ranging in age from 5 to 11 ( M = 7.7 ) participated in the study .
RESULTS	Attention and memory scores increased over time in all children , however , the analyses showed no significant negative effects of anticholinergic medications on attention or memory .
RESULTS	Indeed , though not statistically significant , trends were for improvement in test scores in both areas .
CONCLUSIONS	Our results in a double blinded cross-over trial suggest that long-acting oxybutynin and tolterodine do not have a deleterious effect on children 's attention and memory .
CONCLUSIONS	Other cognitive functions may be affected .

###12485118
BACKGROUND	The effects of nocturnal gastric acid breakthrough ( NAB ) on Helicobacter pylori eradication are still unknown in peptic ulcer patients .
BACKGROUND	The purposes of this study were to compare the effect of lansoprazole 30 mg twice a day ( bid ) to lansoprazole 60 mg once a day ( qd ) on the prevalence of NAB , and to determine whether NAB affects the eradication of H. pylori in peptic ulcer patients .
METHODS	Experiments were carried out in 67 patients with H. pylori-positive peptic ulcers .
METHODS	They were randomized into two groups , one treated with a combination of lansoprazole 60 mg , clarithromycin 1.0 g , and amoxycillin 2.0 g once a day before breakfast ( qd group ) , and the other , divided doses of the drugs were given before breakfast and dinner ( bid group ) for 2 weeks .
RESULTS	NAB occurred in 31 patients , 55.2 % in qd group , and 39.5 % in bid group ( p = .226 ) .
RESULTS	H. pylori eradication was achieved in 61.3 % in NAB positive group and 83.3 % in NAB negative group ( p = .055 ) .
RESULTS	The mean duration of NAB for H. pylori eradication group was 99.3 + / - 22.7 min , and 293.2 + / - 49.8 min for H. pylori persistence group ( p < .05 ) .
RESULTS	The median intragastric pH of the H. pylori eradication and persistence group was 5.7 + / - 0.2 and 4.2 + / - 0.4 , respectively ( p < .05 ) .
CONCLUSIONS	Neither the morning dose and the divided dose regimen of lansoprazole affected the intragastric acidity and occurrence of the NAB .
CONCLUSIONS	NAB did not influence H. pylori eradication in peptic ulcer patients , but the duration of NAB and total intragastric median pH were found to influence the H. pylori eradication .

###24710957
BACKGROUND	Succinylcholine provides rapid onset of neuromuscular blockade and short duration of action , but its administration may be associated with hyperkalemia .
BACKGROUND	Rocuronium is not known to increase potassium concentration , has fast onset of activity , and can be rapidly reversed by sugammadex .
BACKGROUND	This study evaluated changes in plasma potassium concentrations in patients randomized either to rocuronium followed by sugammadex reversal or to succinylcholine in ambulatory surgery .
METHODS	In this multicentre randomized active-controlled study , adult patients undergoing short surgical procedures in an outpatient setting received either rocuronium 0.6 mgkg ( -1 ) for intubation with sugammadex 4.0 mgkg ( -1 ) for reversal ( n = 70 ) or succinylcholine 1.0 mgkg ( -1 ) with spontaneous recovery ( n = 80 ) .
METHODS	Blood potassium concentrations were assessed at baseline ( before study drug administration ) and at intervals up to 15min after rocuronium , sugammadex , and succinylcholine .
RESULTS	At the primary endpoint , five minutes post-administration , the changes in potassium concentrations from baseline were significantly smaller in patients treated with rocuronium than in those given succinylcholine [ mean ( SD ) : -0.06 ( 0.32 ) vs 0.30 ( 0.34 ) mmolL ( -1 ) , respectively ; P < 0.0001 ] .
RESULTS	At baseline , potassium concentrations were similar in both groups , but they were greater at two , five , ten , and 15min after succinylcholine than after rocuronium ( P < 0.0001 ) for all time points .
RESULTS	After sugammadex administration , there were no significant changes in mean potassium concentration from the pre-rocuronium baseline .
RESULTS	No adverse effects related to hyperkalemia were observed .
CONCLUSIONS	Succinylcholine was associated with a modest increase in potassium concentration ; these changes were not seen after rocuronium or sugammadex (
BACKGROUND	NCT00751179 ) .

###19458018
BACKGROUND	Food reinforcement , ie , motivation to obtain food , is associated with energy intake and obesity .
BACKGROUND	Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and maintenance of weight loss .
BACKGROUND	Our previous study in nonobese adults showed that daily consumption of the same snack food ( food consumed apart from meals ) for 14 d significantly decreased its reinforcing value .
OBJECTIVE	The aims of this study were to replicate and extend these findings to obese individuals and to examine the effects of different portion sizes of snack foods on food reinforcement .
METHODS	Food reinforcement and liking were tested in 31 obese and 27 nonobese women at baseline and after 2 wk of daily consumption of 0 , 100 , or 300 kcal/d of the same snack food .
RESULTS	We found a significant interaction of phase , portion size , and body mass index on the pattern of operant responding for food .
RESULTS	Obese women had a significant increase in food reinforcement after consuming the 300-kcal portion of food for 2 wk , whereas nonobese women had the opposite response .
RESULTS	No significant differences were found on the reinforcing value with the 0 - and 100-kcal portion-size conditions .
RESULTS	Women in the 300-kcal group ( obese and nonobese ) reported a significant decrease in snack food liking from baseline to after daily intake .
CONCLUSIONS	These findings suggest that obese and nonobese women respond differently to the daily intake of a snack food and that this may not be a viable mechanism for reducing food reinforcement in obese women .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT00837694 .

###25307169
BACKGROUND	Omega-3 polyunsaturated fatty acid ( PUFA ) may benefit humans and animals with chronic inflammatory diseases .
OBJECTIVE	Omega-3 PUFA supplementation improves clinical signs , lung function , and airway inflammation in horses with recurrent airway obstruction ( RAO ) and inflammatory airway disease ( IAD ) .
METHODS	Eight research horses and 35 client-owned horses .
METHODS	A pilot study examined the dose of PUFA that can alter plasma PUFA composition .
METHODS	Then , a randomized , controlled clinical trial was performed in horses with RAO and IAD .
METHODS	Horses were fed a complete pelleted diet with no hay and randomly assigned to 1 of 3 daily treatments for 2 months : 30 or 60 g of the supplement or 30 g of placebo .
METHODS	Clinical signs , lung function , plasma PUFA composition , and bronchoalveolar lavage fluid ( BALF ) cytology were evaluated .
METHODS	Data were expressed as median ( 25-75th percentiles ) .
METHODS	P < .05 was considered significant .
RESULTS	Polyunsaturated fatty acid supplementation resulted in increased plasma docosahexaenoic acid ( DHA ) that peaked at 4 weeks .
RESULTS	Clinical improvement was noted in all horses involved in the clinical trial , but the group that received PUFA had greater improvement in clinical signs ( cough score improved 60 % ) , lung function ( respiratory effort decreased 48 % ) , and BALF ( neutrophils decreased from 23 to 9 % ) when compared to placebo ( cough score improved 33 % , respiratory effort decreased 27 % , BALF neutrophils increased from 11 to 17 % ; P < .05 ) .
CONCLUSIONS	Feeding horses with RAO and IAD a PUFA supplement containing 1.5-3 g DHA for 2 months provides an additional benefit to low-dust diet .

###17066294
OBJECTIVE	To describe the scenario and frequency of drug-related problems ( DRPs ) in in-patients and to determine whether a pharmacotherapeutic advisory intervention aiming at reducing DRPs could affect rates of re-hospitalisation and/or death within 6 months .
METHODS	This prospective , randomised , controlled advisory intervention study was carried out at the Clinic of Internal Medicine at Stockholm Sder Hospital .
METHODS	Three hundred patients from four wards took part in the study .
METHODS	Patients taking two drugs or more were included .
METHODS	In the intervention arm , potential drug interactions were found using a computer system .
METHODS	Medical symptoms were estimated by a nurse together with the patient .
METHODS	Creatinine clearance was calculated .
METHODS	Thereafter a clinical pharmacologist scrutinised the patient s medical record for DRPs together with the nurse .
METHODS	DRPs judged to be clinically relevant resulted in written advice to the physician in charge of the patient .
METHODS	The control group received usual care .
RESULTS	In the intervention group , a total of 299 DRPs were found among 71 % of the patients ( 106/150 ) .
RESULTS	The number of written letters of advice to the physicians in charge was 106 .
RESULTS	Of these , 63 % were accepted .
RESULTS	After 6 months , the proportion of re-hospitalisations or death in the intervention group was 49 % ( 73/150 ) compared to 46 % ( 69/150 ) in the control group .
RESULTS	The difference was not significant .
CONCLUSIONS	DRPs were common .
CONCLUSIONS	Potential drug interactions and adverse drug reactions dominated .
CONCLUSIONS	Hospital-based medication review by a clinical pharmacologist was not associated with reduced rates of re-hospitalisation and/or death .
CONCLUSIONS	The clinical relevancy of DRPs might be overestimated as a risk for re-hospitalisation or death .
CONCLUSIONS	It is of great importance to clarify if and how drug-related problems can be prevented .
CONCLUSIONS	In designing such studies , one should consider choosing inclusion criteria that accumulate risk .

###20668354
BACKGROUND	Atrial fibrillation ( AF ) after rheumatic valve replacement is the most common arrhythmic complication .
BACKGROUND	Previous studies reported angiotensin-II receptor blocker can prevent AF .
BACKGROUND	This study aimed to assess the effect of a combination of irbesartan and amiodarone on the maintenance of sinus rhythm after cardioversion of AF in patients with post-rheumatic valve replacement in a randomized , controlled trial .
RESULTS	Eighty-five consecutive patients undergoing rheumatic valve surgery were enrolled and randomly assigned to an irbesartan plus amiodarone ( irbesartan 150 mg/d , n = 43 ) or an amiodarone group ( n = 42 ) starting 10 days before scheduled electrical cardioversion .
RESULTS	The primary end-point was recurrence of AF .
RESULTS	Pharmacological conversion was documented in 7 patients , and electrical conversion in 68 patients ( 87.2 % ) .
RESULTS	A higher rate of maintenance of sinus rhythm ( 69.8 % vs 40.5 % , P = 0.01 ) and a better AF-free survival ( chi ( 2 ) = 7.466 , P = 0.006 ) were observed in the irbesartan plus amiodarone group compared to the amiodarone group during the 1-year follow-up period .
RESULTS	Cox regression showed that use of irbesartan was an independent factor associated with the maintenance of sinus rhythm after cardioversion ( OR = 0.43 , P = 0.018 ) , whereas increased left atrium diameter was associated with increased risk ( OR = 1.54 , P = 0.005 ) .
CONCLUSIONS	In patients with post-rheumatic valve replacement , the combination of amiodarone and irbesartan demonstrated a lower rate of AF recurrence after cardioversion than amiodarone alone , which might be due to preventing the atrial remodeling .

###23274779
OBJECTIVE	To evaluate effectiveness of carboxymethylcellulose/polyethylene oxide ( CMC/PEO ) gel in improving clinical outcomes after the first-time lumbar discectomy .
METHODS	Ninety-three patients with herniated lumbar disc at L4-L5 or L5-S1 were enrolled and randomized into two groups : CMC/PEO gel treatment group and control group .
METHODS	All the patients underwent laminotomy and discectomy by posterior approach .
METHODS	The preoperative and postoperative Oswestry Disability Index ( ODI ) and Visual Analogue Scale ( VAS ) scores for lower-back pain and leg pain were analyzed and compared between two groups at 30 - and 60-day time points .
RESULTS	No patient presented with any clinically measurable adverse event during surgery .
RESULTS	There were no significant differences between the treated group and the control group on the preoperative ODI and VAS scores .
RESULTS	In general , the ODI and VAS scores decreased in both groups at all the time points .
RESULTS	At the 30-day time point , the VAS scores for back pain and leg pain and the ODI scores in treatment group were lower by 9.9 % ( P = 0.0302 ) , 27.0 % ( P = 0.0002 ) and 16.3 % ( P = 0.0007 ) than those in control group .
RESULTS	And at the 60-day time point , the ODI and VAS scores further decreased in both groups .
RESULTS	The VAS scores for leg pain in treatment group were lower by 4.5 % than that in the control group ( P = 0.0149 ) .
RESULTS	However , no significant difference was detected between two groups on the ODI and VAS scores for back pain .
CONCLUSIONS	The results demonstrated that CMC/PEO gel is effective in reducing posterior dural adhesions in the spine with no apparent safety issues .
CONCLUSIONS	It can improve patients ' postoperative clinical outcome .

###19562997
OBJECTIVE	To study the therapeutic effect of splenic autotransplantation combined with lower esophagus transaction anastomosis in the treatment of liver cirrhosis induced portal hypertension .
METHODS	Thirty-six patients admitted from January 2003 to December 2006 were randomly divided into splenic autotransplantation group undergoing splenic autotransplantation after splenectomy combined with lower esophagus transaction anastomosis , and splenectomy group only undergoing splenectomy combined with lower esophagus transaction anastomosis .
METHODS	The general conduction , splenic scanning , liver function , and the level of serum Tuftsin and IgM of each patient were observed before and after operation .
RESULTS	The levels of Tuftsin and IgM in splenic autotransplantation group were significant higher than that of splenectomy group 2 months after the operation , and the liver function showed no significant difference between these two groups .
RESULTS	Splenic tissue was detected in the retroperitoneal space by 99mTc-DRBC 2 months after operation .
CONCLUSIONS	Splenic autotransplantation combined with lower esophagus transaction anastomosis is a safe and effective treatment strategy for patients with liver cirrhosis induced portal hypertension , and the spleen tissue transplanted into the retroperitoneal space can partially preserve the immune function .

###25553889
BACKGROUND	Novel therapies are needed for difficult-to-treat populations of patients with psoriasis .
OBJECTIVE	We sought to assess the efficacy and safety of the interleukin-17 Receptor A inhibitor brodalumab in patients with psoriasis with or without a self-reported history of psoriatic arthritis ( PsA ) and with or without a history of biologic use .
METHODS	Subset analyses of a phase II , randomized , double-blind , placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis were performed .
METHODS	Improvement from baseline in Psoriasis Area and Severity Index score of 75 % , 90 % , and 100 % at week 12 ; static Physician Global Assessment ( 0/1 ) score ; Dermatology Life Quality Index response ; and Psoriasis Symptom Inventory response were evaluated within subgroups .
RESULTS	Efficacy and quality-of-life measures were generally similar between subgroups of patients with or without a history of PsA and with or without a history of biologic use across brodalumab doses and were significantly higher among patients who received brodalumab 140 mg every 2 weeks or 210 mg every 2 weeks versus placebo .
CONCLUSIONS	Differences between subgroups were not compared statistically , PsA was self-reported , only skin involvement/symptoms were reported , and reasons for discontinuation of prior biologic were not captured .
CONCLUSIONS	Brodalumab is efficacious in patients with psoriasis with or without a history of PsA or biologic use .

###9553237
BACKGROUND	With a tourniquet on arm for arresting venous blood flow , we evaluated the efficacy of intravenous ( i.v. ) retention of fentanyl and lidocaine in reducing the pain on i.v. propofol injection during general anesthesia .
METHODS	One hundred and twelve patients were studied .
METHODS	Following a venous occlusion by a tourniquet inflated to 70 mmHg , patients in Group A ( n = 38 ) received normal saline ( NS ) 3 ml , while those in Group B ( n = 37 ) and in Group C ( n = 37 ) respectively received fentanyl 150 micrograms or 3 ml and 2 % lidocaine 3 ml ( 60 mg ) .
METHODS	The venous retention of drug was maintained for 1 min , followed immediately by tourniquet release and propofol 100 mg i.v. injection over 20 s.
RESULTS	Both fentanyl and lidocaine treatments ( Groups B and C ) were significantly better than placebo ( Group A ) in reducing pain on propofol injection ( p < 0.005 ) .
RESULTS	Lidocaine 60 mg was more effective than fentanyl 150 micrograms in reduction of pain associated with i.v. propofol ( p < 0.001 ) .
RESULTS	Injection of fentanyl itself caused pain in 28 % of patients as compared to 2 % in the lidocaine group .
RESULTS	Mild local skin erythema was noted in 14 % of patients with fentanyl venous retention versus 0 % of patients with lidocaine venous retention .
CONCLUSIONS	Intravenous retention of fentanyl 150 micrograms , although less effective than that of lidocaine ( p < 0.001 ) , showed local analgesic effect in reducing the pain on propofol injection .
CONCLUSIONS	The hypothetic mechanisms of action were speculated .

###9126126
OBJECTIVE	To determine if preoperative patient verbalization of the risks and benefits of anterior cruciate ligament ( ACL ) reconstruction enhances understanding of the risks and benefits of that procedure .
METHODS	A randomized clinical trial .
METHODS	A referral-based outpatient sport medicine clinic .
METHODS	Twenty patients from the general population with clinically diagnosed ACL tears requiring elective reconstruction surgery were randomly assigned to 2 groups .
METHODS	Twelve patients who made up a control group received a standard surgical consultation , consisting of knee models , diagrams , open dialogue and informed consent to surgery .
METHODS	Eight patients in the experimental group were exposed to the same surgical consultation and were required to accurately verbalize the associated risks and benefits before operation .
METHODS	One month after informed consent was obtained , patients answered 3 questions about the risks and benefits of ACL reconstruction .
METHODS	ACL reconstruction .
METHODS	A 3-question questionnaire , addressing 2 risks and 1 benefit of ACL reconstruction .
RESULTS	Patients in the experimental group were able to answer all 3 questions correctly .
RESULTS	In the control group , 4 patients answered all 3 questions correctly , but 1 patient answered all 3 questions incorrectly , and 7 patients answered 1 question incorrectly .
RESULTS	There was a statistically significant difference ( p = 0.03 ) between the control group and the experimental group .
CONCLUSIONS	Patients who verbalized the risks and benefits during their surgical consultation demonstrated a significantly greater understanding of the risks and benefits of an ACL reconstruction procedure .

###18218061
OBJECTIVE	To evaluate the feasibility of implementing a diet-based intervention in men with prostate cancer on active surveillance , as changes in diet might potentially inhibit the progression of prostate cancer .
METHODS	As part of the Men 's Eating and Living ( MEAL ) Study ( a multicentre pilot trial of a diet-based intervention for prostate cancer ) 43 men aged 50-80 years with prostate cancer and on active surveillance were randomized to receive either telephone-based dietary counselling or standardized , written nutritional information .
METHODS	Telephone counselling targets included increased intakes of vegetables ( particularly cruciferous vegetables and tomato products ) , whole grains , and beans/legumes .
METHODS	Dietary intakes and plasma carotenoid levels were assessed at baseline and at after 6 months .
RESULTS	In the intervention arm the mean daily intakes of total vegetables , crucifers and tomato products increased by 71 % , 180 % and 265 % , respectively ( P < 0.05 ) ; in the control arm there were no significant changes in mean intakes of these components .
RESULTS	Similarly , in the intervention arm , mean plasma levels of alpha-carotene , beta-carotene , lutein , lycopene and total carotenoids increased by 37 % , 32 % , 23 % , 30 % and 25 % , respectively ( P < 0.05 ) ; in the control arm there were no significant changes in plasma levels of these components .
RESULTS	There were no significant changes in either group in whole grain , beans/legumes , or fat intake .
CONCLUSIONS	Telephone-based dietary counselling increases vegetable intake and plasma concentrations of potentially anticarcinogenic carotenoids in men with prostate cancer on active surveillance .
CONCLUSIONS	These data support the feasibility of implementing clinical trials of diet-based interventions in this population .

###16490891
OBJECTIVE	The addition of molgramostim ( recombinant human granulocyte-macrophage colony-stimulating factor ) to antibiotic therapy for nontraumatic and generalized abdominal sepsis is effective and has a significant impact on length of hospitalization , direct medical costs , and mortality .
METHODS	Randomized , double-blind , placebo-controlled clinical trial .
METHODS	Tertiary referral center .
METHODS	Fifty-eight patients with abdominal sepsis .
METHODS	Patients were allocated to receive , in addition to ceftriaxone sodium , amikacin sulfate , and metronidazole , molgramostim in a daily dosage of 3 microg/kg for 4 days ( group 1 ) or placebo ( group 2 ) .
METHODS	Antibiotics were administered for at least 5 days and discontinued after clinical improvement had occurred and white blood cell count had been normal for 48 hours .
METHODS	Time to improvement , duration of antibiotic therapy , hospital stay , complications , mortality , and adverse reactions to drugs .
RESULTS	Median time to improvement was 2 days in group 1 and 4 days in group 2 ( P < .005 ) .
RESULTS	Median length of hospitalization was 9 and 13 days , respectively ( P < .001 ) , and median duration of antibiotic therapy was 9 and 13 days , respectively ( P < .001 ) .
RESULTS	Numbers of infectious complications in the 2 groups were , respectively , 6 and 16 ( P = .02 ) ; of residual abscesses , 3 and 5 ; and of deaths , 2 and 2 .
RESULTS	Costs per patient were 12,333 dollars and 16,081 dollars ( US dollars ) , respectively .
CONCLUSIONS	Addition of molgramostim to antibiotic therapy reduces the rate of infectious complications , the length of hospitalization , and costs in patients with nontraumatic abdominal sepsis .

###12123405
BACKGROUND	A large discrepancy exists between the wishes of dying patients and their actual end-of-life care .
BACKGROUND	However , retrospective clinical experience suggests that early advance care planning ( ACP ) can markedly reduce this discrepancy .
BACKGROUND	This article describes a randomized trial to evaluate the short-term clinical utility of early ACP .
BACKGROUND	We also assessed the feasibility of performing a larger prospective study to document long-term outcomes .
METHODS	Ambulatory geriatric patients ( N = 61 ) were randomized to either a control group , which received only a Massachusetts Health Care Proxy form to complete , or an intervention group , in which each patient and health care agent discussed ACP with a trained nurse facilitator .
METHODS	The benefits and burdens of life-sustaining treatments were discussed , and patient goals and preferences for these treatments were documented .
RESULTS	Two-month follow-up revealed that the intervention achieved higher congruence between agents and patients in their understanding of patients ' end-of-life care preferences , with 76 % ( 19/25 ) in complete agreement vs 55 % ( 12/22 ) of the controls ( effect size [ ES ] = -0.43 ) .
RESULTS	There was also a greater increase in patient knowledge about ACP in the intervention group ( ES = 0.22 ) .
RESULTS	Intervention patients became less willing to undergo life-sustaining treatments for a new serious medical problem ( ES = -0.25 ) , more willing to undergo such treatments for an incurable progressive disease ( ES = 0.24 ) , and less willing to tolerate poor health states ( ES = -0.78 ) .
RESULTS	Practical insights were gained about how to conduct a larger study more effectively .
CONCLUSIONS	A facilitated discussion about end-of-life care between patients and their health care agents helps define and document the patient 's wishes for both patient and agent .

###19787287
OBJECTIVE	To evaluate the efficacy and safety of ultrasound-guided percutaneous catheter drainage ( PCD ) treatment for severe acute pancreatitis compared to conservative and conventional surgical treatments .
METHODS	Eighty-one patients with severe acute pancreatitis ( SAP ) were admitted and divided into three groups : forty-nine cases in the conservative therapy group ; nineteen cases in the surgery group ; and thirteen cases in the PCD therapy group .
METHODS	Forty-five patients with a CT severity index ( CTSI ) < or = 8.0 received conservative treatment .
METHODS	One patient with CTSI = 7.0 underwent surgery .
METHODS	Thirty-five patients with a CTSI > 8.0 were randomly selected for surgery or PCD treatment .
METHODS	After randomization , six patients ( four patients in the surgery group and two patients in the PCD group ) were dropped from the study .
METHODS	The total number of patients included in the surgery and PCD groups was sixteen and thirteen , respectively .
RESULTS	Four patients ( 8.2 % ) in the conservative therapy group died , five patients ( 31.3 % ) in surgery group with a CTSI > 8.0 died , and all patients in the PCD group survived .
RESULTS	The mortality rate was lower in the PCD group than in the surgery group ( P = 0.048 ) .
RESULTS	The serum C-reactive protein ( CRP ) level recovered more quickly in patients in the PCD group compared to those in the surgery group ( P < 0.001 ) .
CONCLUSIONS	Patients with SAP and a CTSI < or = 8.0 could be treated with conservative therapy , while patients with a CTSI > 8.0 should be treated with surgery or PCD therapy if the life-threatening complications of extensive fluid collection or necrosis are a factor .
CONCLUSIONS	However , PCD therapy used in a timely manner for drainage may decrease mortality in patients with SAP , decrease inflammatory mediator release , and avoid incidence of severe sepsis or acute respiratory distress syndrome ( ARDS ) and emergency surgery .

###24752165
BACKGROUND	Morbid obese ( MO ) population is increasing every year worldwide , and laparoscopic bariatric surgery ( LBS ) has a central role in their treatment .
BACKGROUND	The postoperative period of MO is not free from complications .
BACKGROUND	The introduction of sugammadex has brought huge developments in patient 's safety and nowadays LBS is performed with better care and quality .
BACKGROUND	However , the effect of this agent in postoperative pain is still unknown .
METHODS	A controlled trial enrolling 88 MO submitted to LBS under general anesthesia using muscle relaxation , randomly assigned into 2 groups : one received sugammadex ( SUG group ) at the end of surgery and the other neostigmine ( NEO group ) .
METHODS	In the postanesthetic care unit ( PACU ) , we evaluated pain using the visual analogue scale in 4 different moments : arrival in the PACU , 30 minutes after arrival , 60 minutes after arrival , and immediately before leaving the PACU .
METHODS	We also recorded the presence of postoperative nausea and vomits ( PONV ) and the duration of the PACU stay before discharge to the ward .
RESULTS	Forty-four patients received sugammadex and 44 received neostigmine .
RESULTS	We found lower visual analogue scale pain scores in the SUG group at 30 and 60 minutes after arriving to the PACU ( P < 0.05 ) .
RESULTS	We also had less PONV in the SUG group and these patients were also discharged earlier .
CONCLUSIONS	Sugammadex is associated with less pain felt in the PACU .
CONCLUSIONS	This `` opioid-sparing '' effect , combined with less PONV and a faster discharge from the PACU , makes sugammadex an indispensable drug in this type of patients and allows fast-track surgery in the MO. .

###16167793
BACKGROUND	The aim of this study was to investigate which dose of fentanyl in ropivacaine for epidural anesthesia will provide effective analgesia with minimal side effects after cesarean section ( CS ) .
METHODS	Fifty eight patients scheduled for CS were randomly allocated to two groups according to fentanyl dose in epidural analgesia : group F1 ( 11 microg x hr ( -1 ) ; n = 30 ) or group F 2 ( 21 microg x hr ( -1 ) ; n = 28 ) .
METHODS	Ropivacaine 0.2 % 100 ml with fentanyl 400 or 800 microg was administered into the epidural space in the groups F1 and F 2 , respectively .
METHODS	Pain scores ( visual analogue scale : VAS ) with cough or movement , Bromage score , incidence of diclofenac or pentazocine administration , satisfaction score ( VAS ) and side effects ( nausea , vomiting and pruritus ) were recorded after CS .
RESULTS	Pain scores with cough or movement were significantly lower in the group F 2 than the group F 1 at twelve and twenty-four hours after CS .
RESULTS	Bromage score at twelve hours was lower in the group F 2 than the group F 1 .
RESULTS	The incidences of side effects were similar between the two groups .
RESULTS	Satisfaction score was significantly higher in the group F 2 than the group F 1 .
CONCLUSIONS	We conclude that continuous epidural administration of fentanyl 21 microg x hr ( -1 ) with ropivacaine provides the optimum balance between pain relief and side effects compared with fentanyl 11 microg x hr ( -1 ) with ropivacaine after CS .

###21482613
OBJECTIVE	The goal of this study was to compare the effectiveness of a youth-friendly HIV video with in-person counseling in conveying HIV knowledge and obtaining consent for HIV testing among adolescent patients of an urban emergency department .
METHODS	A 2-armed , randomized controlled trial was conducted on a convenience sample of 200 stable , sexually active people aged 15 to 21 years in an urban emergency department .
METHODS	Participants in both the in-person counseling group and the video intervention group completed preintervention and postintervention HIV knowledge measures .
METHODS	HIV knowledge was the primary outcome measure , and consent for HIV testing was the secondary outcome .
METHODS	Characteristics associated with voluntary HIV testing were identified .
RESULTS	Of 333 eligible people , 200 agreed to participate .
RESULTS	There was no difference in preintervention HIV knowledge scores between groups .
RESULTS	Mean postintervention knowledge scores differed significantly between the video ( 78.5 % correct ) and the counselor ( 66.3 % correct ) ( P < 0.01 ) groups .
RESULTS	Overall , 51 % of the video group accepted HIV testing compared with 22 % in the control group ( P < .01 ) .
RESULTS	Watching the video ( OR : 3.6 [ 95 % CI : 1.8-7 .2 ] ) , being female ( OR : 2.1 [ 95 % CI : 1.0-4 .2 ] ) , engaging in oral sex ( OR : 2.8 [ 95 % CI : 1.4-5 .9 ] ) , and being older than 18 years ( OR : 3.8 [ 95 % CI : 1.8-7 .8 ] ) were all positively associated with testing .
CONCLUSIONS	A youth-friendly HIV educational video improved adolescents ' HIV knowledge and increased their participation in HIV testing more than in-person counseling .
CONCLUSIONS	video-based HIV counseling can perform as well or better than in-person counseling for adolescents in the ED .

###22866291
OBJECTIVE	To evaluate whether 5 5 mm dental implants with a novel nanostructured calcium-incorporated titanium surface could be an alternative to at least 5 10 mm-long implants placed in bone augmented with bone substitutes in posterior atrophic jaws .
METHODS	Forty patients with atrophic posterior ( premolar and molar areas ) mandibles having 5 to 7 mm of bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 6 mm below the maxillary sinus , were randomised according to a parallel group design to receive one to three 5 5 mm implants or one to three at least 5 10 mm-long implants in augmented bone at two centres .
METHODS	Mandibles were vertically augmented with interpositional bovine bone blocks and resorbable barriers and implants were placed after 4 months .
METHODS	Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously .
METHODS	All implants were submerged and loaded after 4 months with provisional prostheses .
METHODS	Four months later , definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered .
METHODS	Outcome measures were prosthesis and implant failures as well as any complication .
RESULTS	Patients were followed to 4 months post-loading with the exception of one patient who underwent mandibular augmentation and had multiple complications at and after grafting , and subsequent graft failure , who did not want to go ahead with the treatment .
RESULTS	This case was considered a complete failure .
RESULTS	There were no statistically significant differences in prosthesis and implant failures .
RESULTS	In mandibles , apart from the complete graft failure , one 5 10 mm implant failed at placement of the provisional prosthesis .
RESULTS	In maxillae , one 5 5 mm implant failed with its provisional crown 3 months after loading .
RESULTS	All complications occurred before loading .
RESULTS	Significantly more intra - and postoperative complications occurred at both mandibular and maxillary grafted sites : 16 augmented patients were affected by complications versus 8 patients treated with short implants in the mandible ( P = 0.022 ; difference in proportion = 0.40 ; CI 95 % 0.12 to 0.68 ) , and 5 sinus-lifted patients versus none treated with maxillary short implants ( P = 0.047 ; difference in proportion = 0.25 ; CI 95 % 0.06 to 0.44 ) .
CONCLUSIONS	Short-term data ( 4 months after loading ) indicate that 5 5 mm implants achieved similar results compared to longer implants placed in augmented bone .
CONCLUSIONS	Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity .
CONCLUSIONS	However , 5 to 10 years of post-loading data are necessary before making reliable recommendations .

###16575620
OBJECTIVE	A randomized study was performed to assess whether new technologies offer advantages over the conventional technique on the clinical and functional outcome of patients with full-thickness rectal prolapse and fecal incontinence , submitted to Altemeier 's procedure with levatorplasty .
METHODS	Between January 1999 and December 2003 , 58 patients ( 55 females ; mean age , 70.9 + / - 11.3 years ) with full-thickness rectal prolapse were evaluated with continence score , colonoscopy , anorectal manometry , anal electromyography , and sacral reflex latency ; 40 of them were selected and randomly assigned to two groups : 20 patients ( Group 1 ; 19 females , 73.4 + / - 10.4 years ) were submitted to a conventional operation with monopolar electrocautery and handsewn anastomosis , and 20 ( Group 2 ; 18 females , 71.5 + / - 12.2 years ) using harmonic scalpel and circular stapler .
METHODS	Patients were followed up with clinical examination , anorectal manometry , and anal electromyography , with mean follow-up 29.3 + / - 8.5 and 27.5 + / - 9.2 months in Groups 1 and 2 , respectively .
RESULTS	Operative time , blood loss , and hospital stay were significantly reduced in Group 2 ( P < 0.001 ) , whereas no differences were found in pain score , time to return to normal activity , morbidity , and mortality .
RESULTS	Complications were two ( 10 percent ) stenosis in Group 1 .
RESULTS	Fecal continence score significantly improved in both groups ( P < 0.01 ) , whereas anorectal manometry and neurophysiologic data were not significantly modified by the operation .
RESULTS	Recurrence rates were 15 and 10 percent in Groups 1 and 2 , respectively ( P = not significant ) .
CONCLUSIONS	The clinical and functional long-term results of perineal rectosigmoidectomy with levatorplasty are not influenced by surgical instruments and type of coloanal anastomosis .
CONCLUSIONS	The clinical relevance of the short-term results in high-risk patients should be specifically investigated .

###12511716
BACKGROUND	A study was undertaken to determine the effectiveness of asthma self-management in general practice .
METHODS	Nineteen general practices were randomly allocated to usual care ( UC ) or self-management ( SM ) .
METHODS	Asthma patients were included after confirmation of the GP diagnosis .
METHODS	Follow up was 2 years .
METHODS	Patients kept diary cards and visited the lung function laboratory every 6 months .
METHODS	Outcomes were number of successfully treated weeks , limited activity days , asthma specific quality of life , forced expiratory volume in 1 second ( FEV ( 1 ) ) , FEV ( 1 ) reversibility , concentration of histamine provoking a fall in FEV ( 1 ) of 20 % or more ( PC ( 20 ) histamine ) , and amount of inhaled steroids .
RESULTS	A total of 214 patients were included in the study ( 104 UC/110 SM ; one third of the total asthma population in general practice ) ; 62 % were female .
RESULTS	The mean percentage of successfully treated weeks per patient in the UC group was 72 % ( 74/103 weeks ) compared with 78 % ( 81/105 weeks ) in the SM group ( p = 0.003 ) .
RESULTS	The mean number of limited activity days was 1.2 ( 95 % CI 0.5 to 1.9 ) in the SM group and 3.9 ( 95 % CI 2.5 to 5.4 ) in the UC group .
RESULTS	The estimated increase in asthma quality of life score was 0.10 points per visit in the UC group and 0.21 points per visit in the SM group ( p = 0.055 ) .
RESULTS	FEV ( 1 ) , FEV ( 1 ) reversibility , and PC ( 20 ) histamine did not change .
RESULTS	There was a saving of 217 puffs of inhaled steroid per patient in favour of the SM group ( p < 0.05 ) .
CONCLUSIONS	Self-management lowers the burden of illness as perceived by patients with asthma and is at least as effective as the treatment usually provided in Dutch primary care .
CONCLUSIONS	Self-management is a safe basis for intermittent treatment with inhaled corticosteroids .

###23382470
OBJECTIVE	To compare the safety and efficacy of corticorelin acetate ( CrA ) and placebo in patients with malignant brain tumors requiring chronic administration of dexamethasone ( DEX ) to control the signs and symptoms of peritumoral brain edema ( PBE ) .
METHODS	Prospective , randomized , double-blind study of 200 patients with PBE on a stable dose of DEX .
METHODS	Initially , DEX dose was decreased by 50 % over a 2-week period and then held at this level for 3 weeks .
METHODS	The primary end point was the proportion of patients who responded to treatment-patients who achieved a 50 % DEX reduction from baseline and achieved stable or improved neurologic examination score and Karnofsky performance score at week 2 , and then continued to respond at week 5 .
RESULTS	One hundred patients received subcutaneous injections of 1 mg twice per day of CrA and 100 patients received placebo for the duration of the study period .
RESULTS	Although results did not attain statistical significance ( at the P < .05 level ) , a clinically important difference in the proportion of responders between the CrA group ( 57.0 % ) and the placebo group ( 46.0 % ; P = .12 ) was observed .
RESULTS	In addition , the maximum percent reduction in DEX dose achieved during the double-blind 12-week study was significantly greater in the CrA group ( 62.7 % ) than in placebo group ( 51.4 % ; P < .001 ) .
RESULTS	Patients receiving CrA demonstrated an improvement in myopathy and were less likely to develop signs of Cushing syndrome .
CONCLUSIONS	CrA enables a reduction in steroid requirement for patients with PBE and is associated with a reduction in the incidence and severity of common steroid adverse effects , including myopathy .

###24685847
BACKGROUND	Chronic urticaria not responsive to antihistamines is a difficult disease to manage .
BACKGROUND	Methotrexate has been used in difficult chronic urticarias with some benefit .
OBJECTIVE	To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics .
METHODS	In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre , 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited .
METHODS	Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo ( calcium carbonate ) for a total duration of 12 weeks , after which treatment was stopped and patients were followed up for relapse of urticaria .
METHODS	Each group also received levocetrizine 5 mg once daily for symptom control .
METHODS	Primary outcome measured was a reduction by > 2/3 rd of baseline urticaria scores after 12 week therapy .
METHODS	Secondary outcome was a reduction in antihistamine requirement after stopping therapy .
RESULTS	Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group .
RESULTS	Out of 17 patients who completed therapy , the primary outcome was achieved by 3.5 1.9 ( out of 10 ) patients in the methotrexate group and by 3.67 1.03 ( out of 7 ) patients in the placebo group ( P > 0.05 ) .
RESULTS	Ten patients followed up , after stopping therapy , for a mean period of 3.5 2.4 months ; 3 remained in remission and 7 had relapsed .
RESULTS	One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study .
RESULTS	The placebo group did not experience any side effects .
CONCLUSIONS	Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility .

###15090768
OBJECTIVE	To examine the effect of adding nevirapine ( NVP ) and/or hydroxyurea ( HU ) to a triple nucleoside analogue reverse transcriptase inhibitor ( NRTI ) regimen in terms of efficacy and tolerability .
METHODS	: HIV-1-infected , treatment-naive adults were randomized , using a factorial design , to add NVP and/or HU to the triple NRTI backbone of zidovudine plus lamivudine plus abacavir .
METHODS	Primary endpoint was treatment failure , defined as having plasma HIV RNA levels > 50 copies/ml after week 24 , or discontinuation of randomized treatment .
METHODS	Follow-up was 72 weeks .
RESULTS	For the 229 subjects , median plasma HIV-1 RNA was 4.61 log10 copies/ml and median CD4 cell count was 269 x 10 cells/l .
RESULTS	NVP users reached plasma HIV-1 RNA < 50 copies/ml more rapidly than subjects using no NVP ( log-rank test ; P = 0.011 ) .
RESULTS	In the as-treated analysis , 21.6 % of subjects using NVP versus 48.8 % using no NVP reached the primary endpoint ( P = 0.013 ) .
RESULTS	In the intent-to-treat analysis , 83.3 % of subjects using HU versus 73.0 % using no HU experienced treatment failure ( P = 0.060 ) , while no difference was observed in the as-treated analysis ( 34.5 versus 36.7 % ) .
RESULTS	Differences in the intent-to-treat analysis were accounted for by toxicity : 52.6 % of subjects using HU experienced toxicity leading to discontinuation of randomized treatment versus 28.7 % of subjects using no HU .
CONCLUSIONS	The use of NVP in addition to a triple NRTI regimen improved both short - and long-term antiretroviral efficacy .
CONCLUSIONS	The use of HU significantly contributed to treatment failure because of toxicity .

###8539152
BACKGROUND	Oxygen uptake during constant workload exercise increases exponentially from its resting value before reaching a steady state .
BACKGROUND	The difference between the actual rate of oxygen consumption at the onset of exercise and the steady state is an oxygen deficit .
BACKGROUND	Similarly , the normal sinus node increases its rate at the onset of exercise before achieving a steady state , thereby producing a heart rate deficit .
BACKGROUND	The purpose of this study was to test the hypothesis that elimination of the heart rate deficit by an instantaneous increase in heart rate at the onset of constant workload exercise to the steady-state level would reduce the oxygen deficit and improve the perceived difficulty of exertion as compared with the chronotropic response of the normal sinus node .
RESULTS	Ten subjects with normal sinus node function who had DDD pacemakers implanted for AV block completed a symptom-limited maximal treadmill exercise test using the Chronotropic Assessment Exercise Protocol ( CAEP ) to assess sinus node function , maximal heart rate , and VO2max .
RESULTS	The subjects then performed constant workload exercise tests ( 6-min duration ) at a workload equal to approximately 50 % of metabolic reserve with the pacemaker randomly programmed to each of three patterns of chronotropic response : ( 1 ) DDD ( lower rate 60 beats/min ) ; ( 2 ) Fast ( lower rate abruptly programmed to the expected value at 50 % metabolic reserve ) ; and ( 3 ) Overpaced ( lower rate at least 80 % of the age predicted maximum ) .
RESULTS	The oxygen deficit was lower with the fast chronotropic response ( 434 + / - 238 mL O2 ) than with either the DDD ( 512 + / - 233 ; P = 0.02 ) , or overpaced chronotropic patterns ( 488 + / - 238 ; P = 0.02 vs fast ) .
RESULTS	The rate constant for change in VO2 was highest with the fast chronotropic pattern ( 2.85 + / - 1.38 ) compared with either the DDD ( 2.25 + / - 0.64 ; P = 0.01 ) or overpaced ( 2.38 + / - 0.43 ; P = 0.02 ) patterns .
RESULTS	The Borg perceived exertion rating was lowest with the fast chronotropic response ( P = 0.02 vs DDD and P = 0.02 vs overpaced ) .
CONCLUSIONS	The results of this study suggest that oxygen kinetics and exertional symptoms are improved by an abrupt increase in pacing rate at the onset of exercise to a value that is appropriate for metabolic demand as compared with the DDD pacing mode in patients with normal sinus node function .
CONCLUSIONS	In contrast , an overly aggressive chronotropic response was not associated with improved oxygen kinetics or exertional symptoms .

###16449474
OBJECTIVE	Little is known about clinical features associated with the risk of recurrence in patients with bipolar disorder receiving treatment according to contemporary practice guidelines .
OBJECTIVE	The authors looked for the features associated with risk of recurrence .
METHODS	The authors examined prospective data from a cohort of patients with bipolar disorder participating in the multicenter Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) study for up to 24 months .
METHODS	For those who were symptomatic at study entry but subsequently achieved recovery , time to recurrence of mania , hypomania , mixed state , or a depressive episode was examined with Cox regression .
RESULTS	Of 1,469 participants symptomatic at study entry , 858 ( 58.4 % ) subsequently achieved recovery .
RESULTS	During up to 2 years of follow-up , 416 ( 48.5 % ) of these individuals experienced recurrences , with more than twice as many developing depressive episodes ( 298 , 34.7 % ) as those who developed manic , hypomanic , or mixed episodes ( 118 , 13.8 % ) .
RESULTS	The time until 25 % of the individuals experienced a depressive episode was 21.4 weeks and until 25 % experienced a manic/hypomanic/mixed episode was 85.0 weeks .
RESULTS	Residual depressive or manic symptoms at recovery and proportion of days depressed or anxious in the preceding year were significantly associated with shorter time to depressive recurrence .
RESULTS	Residual manic symptoms at recovery and proportion of days of elevated mood in the preceding year were significantly associated with shorter time to manic , hypomanic , or mixed episode recurrence .
CONCLUSIONS	Recurrence was frequent and associated with the presence of residual mood symptoms at initial recovery .
CONCLUSIONS	Targeting residual symptoms in maintenance treatment may represent an opportunity to reduce risk of recurrence .

###20108776
OBJECTIVE	To explore influence of Kurarinol on specific and non-specific cell immunity in patients with chronic hepatitis B.
METHODS	74 cases of CHB were randomly divided into two groups , 36 cases in treatment group , treated with 600 mg Kurarinol glucose injection , IV , once a day .
METHODS	After one month , Kurarinol capsule was used orally , three times a day for 2 months , 200 mg Silybin Meglumine Tablets orally , three times a day for 3 months .
METHODS	38 cases in control group , only Silybin Meglumine Tablets was used , method and dosage were the same as treatment group .
METHODS	Compare HBV specific CTL , non-specific CTL , sub-group of T cells , changes of Th1 and Th2 , negative conversion rate of HBV DNA and HBeAg of the two groups .
RESULTS	In treatment group , 3 months after treatment with Kurarinol , HBV specific CTL is higher than that before treatment ( P < 0.01 ) , it is also higher than that of control after treatment , P < 0.05 ) .
RESULTS	Non-specific CTL is higher than that before treatment ( P < 0.05 ) , it is also higher than that of control after treatment ( P < 0.01 ) .
RESULTS	CD4 is higher than that before treatment ( P < 0.05 ) , it is also higher than that of control after treatment ( P < 0.01 ) , Thl is higher than that before treatment ( P < 0.05 ) , it is also higher than that of control after treatment ( P < 0.01 ) .
RESULTS	Negative conversion of HBV DNA and HBeAg is higher than that of control ( P < 0.01 ) .
CONCLUSIONS	Kurarinol can improve specific and non-specific cell immunity in patients with CHB .
CONCLUSIONS	It is one of the mechanisms that Kurarinol can clear or inhibit HBV of patients with CHB .

###24490942
BACKGROUND	Metacognitive dysfunction has been widely recognized as a feature of schizophrenia .
BACKGROUND	As it is linked with deficits in several aspects of daily life functioning , improvement of metacognition may lead to improvement in functioning .
BACKGROUND	Individual psychotherapy might be a useful form of treatment to improve metacognition in patients with schizophrenia ; multiple case reports and a pilot study show promising results .
BACKGROUND	The present study aims to measure the effectiveness of an individual , manual-based therapy ( Metacognitive Reflection and Insight Therapy , MERIT ) in improving metacognition in patients with schizophrenia .
BACKGROUND	We also want to examine if improvement in metacognitive abilities is correlated with improvements in aspects of daily life functioning namely social functioning , experience of symptoms , quality of life , depression , work readiness , insight and experience of stigma .
METHODS	MERIT is currently evaluated in a multicenter randomized controlled trial .
METHODS	Thirteen therapists in six mental health institutions in the Netherlands participate in this study .
METHODS	Patients are randomly assigned to either MERIT or the control condition : treatment as usual ( TAU ) .
CONCLUSIONS	If proven effective , MERIT can be a useful addition to the care for schizophrenia patients .
CONCLUSIONS	The design brings along some methodological difficulties , these issues are addressed in the discussion of this paper .
BACKGROUND	Current Controlled Trials : ISRCTN16659871 .

###20015727
BACKGROUND	The aim of this study was to evaluate the efficacy of lidocaine spray 10 % , compared with tetracaine 2 % solution , as a local anesthetic for patients undergoing transnasal fiber-optic laryngoscopy .
METHODS	A prospective study was conducted on patients undergoing transnasal fiber-optic laryngoscopy .
METHODS	Microsurgical sponges were applied in each side of the nose for 10 minutes before laryngoscopy .
METHODS	Patients were randomly classified into group A and group B , in which tetracaine 2 % solution and lidocaine spray 10 % were used , respectively .
METHODS	Patients were asked to evaluate the severity of pain during the procedure by a visual analog scale .
METHODS	Patients data , pain score , and potential complications were placed in a database and statistically assessed .
RESULTS	Our series consisted of 48 patients .
RESULTS	Statistical analysis showed significant lower mean nasal discomfort score in favor of the tetracaine group ( 2.29 vs 3.04 [ P < .001 ] ) .
RESULTS	No tetracaine complications or side effects occurred .
CONCLUSIONS	Neurosurgical sponge application of tetracaine 2 % solution is an easy , safe , inexpensive , and effective analgesia for transnasal fiber-optic laryngoscopy .

###17977294
OBJECTIVE	The aim of the present investigation was to study the effect of daily use of fluoride dentifrices containing various antimicrobial agents on mutans streptococci ( MS ) in saliva and approximal dental plaque .
METHODS	Fifty-nine healthy adolescents , 12-14 years old , undergoing orthodontic treatment with fixed appliances and harbouring high levels of MS in saliva and preferably also in interdental plaque , were randomly distributed into four groups , using dentifrices with : 1 ) zinc lactate ( n = 16 ) , 2 ) amine fluoride-stannous fluoride ( n = 13 ) , 3 ) triclosan ( n = 15 ) , and 4 ) no antimicrobial agent ( control ; n = 15 ) .
METHODS	Changes of MS scores versus baseline were determined after 1 , 3 and 6 months , using the Dentocult SM Strip mutans test .
RESULTS	At the 6-month sampling occasion , the subjects using dentifrice with either amine fluoride-stannous fluoride or triclosan showed a tendency to lower MS scores in interdental plaque ( p < 0.05 ) .
RESULTS	In saliva and in the 1 - and 3-month plaque samples , no changes of MS were detected in any of the four groups .
CONCLUSIONS	This 6-month clinical study showed that dentifrices with various antimicrobial agents only result in small or no changes of the MS scores in saliva and approximal dental plaque in orthodontic patients .

###21203877
BACKGROUND	A previous study using a 180 rotation to insert the ProSeal laryngeal mask airway ( LMA ProSeal ) in children did not show improvement over the standard technique .
BACKGROUND	We used a 90 rotation technique to insert the LMA ProSeal in pediatric patients and compared ease of insertion and pharyngeal trauma with the standard technique .
METHODS	This prospective randomized controlled study included 126 patients aged three to nine years .
METHODS	Anesthesia was induced with thiopental and rocuronium , and the LMA ProSeal used in the study ranged in size from 2 to 3 depending on the patient 's body weight .
METHODS	In the control group ( n = 63 ) , the LMA ProSeal was inserted using the index finger .
METHODS	In the rotation group ( n = 63 ) , the entire cuff of the LMA ProSeal was placed in the patient 's mouth without finger insertion and rotated 90 counter clockwise around the tongue .
METHODS	The LMA ProSeal was then advanced and rotated back until resistance was felt .
METHODS	The primary outcome was the insertion success rate at first attempt .
RESULTS	The success rate of insertion at first attempt was higher with the rotation technique than with the standard technique ( 97 % vs 70 % , respectively ; P < 0.001 ) and the insertion time was shorter ( 16 6 sec vs 30 24 sec , respectively ; P < 0.001 ) .
RESULTS	Mean blood pressure after LMA ProSeal insertion increased significantly in the control group ( 62 12 to 69 17 mmHg ; P = 0.01 ) , but not in the rotation group .
RESULTS	The incidence of blood staining was lower in the rotation group than in the control group ( 10 % vs 25 % , respectively ; P = 0.03 ) , but the incidence of sore throat was not significantly different ( 24 % vs 22 % , respectively ; P = 0.9 ) .
CONCLUSIONS	The 90 rotation technique improves ease of insertion of the LMA ProSeal in children , and it decreases the risk of pharyngeal trauma .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01076725 ) .

###24528999
BACKGROUND	Polychlorinated biphenyls ( PCBs ) and dioxin given to experimental animals increase the blood pressure .
BACKGROUND	We therefore investigated if circulating levels of persistent organic pollutants ( POPs ) were related to hypertension in a population-based sample of men and women .
METHODS	One thousand and sixteen subjects aged 70 years were investigated in the Prospective Investigation of the Vasculature in Uppsala Seniors ( PIVUS ) study .
METHODS	Twenty-three POPs were analyzed using high-resolution gas chromatography/high-resolution mass spectrometry ( HRGC/HRMS ) .
METHODS	Hypertension was defined as a systolic blood pressure 140mmHg or a diastolic blood pressure 90mmHg , and/or use of antihypertensive medication .
RESULTS	Seven hundred and thirty-two subjects ( 72 % ) showed hypertension .
RESULTS	When the POPs were treated as continuous variables and adjusted for gender only , two PCBs with a low number of chlorine atoms ( PCB 105 and 118 ) were related to prevalent hypertension .
RESULTS	Also the OC pesticide p , p ' - DDE was related to hypertension .
RESULTS	The strongest of these associations was seen for p , p ' - DDE ( OR 1.35 for a 1 SD change , 95 % CI 1.17-1 .56 , p < 0.0001 ) .
RESULTS	Following further adjustment also for BMI , smoking status , education level and exercise habits , only p , p ' - DDE was still significantly related to hypertension ( OR 1.23 for a 1 SD change , 95 % CI 1.06-1 .43 , p = 0.006 ) .
CONCLUSIONS	In this cross-sectional analysis of an elderly population , high levels of circulating levels of p , p ' - DDE were associated with prevalent hypertension , further strengthening the experimental findings that POPs might influence blood pressure .

###20691641
BACKGROUND	Spinal and bulbar muscular atrophy is a hereditary motor neuron disease caused by the expansion of a polyglutamine tract in the androgen receptor .
BACKGROUND	At present there are no treatments for spinal and bulbar muscular atrophy , although leuprorelin suppressed the accumulation of pathogenic androgen receptors in a phase 2 trial .
BACKGROUND	We aimed to assess the efficacy and safety of leuprorelin for spinal and bulbar muscular atrophy .
METHODS	The Japan SBMA Interventional Trial for TAP-144-SR ( JASMITT ) was a 48-week , randomised , double-blind , placebo-controlled trial done at 14 hospitals between August , 2006 , and March , 2008 .
METHODS	Patients with spinal and bulbar muscular atrophy were randomly assigned ( 1:1 ) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks .
METHODS	Patients and investigators were masked to treatment allocation .
METHODS	The primary endpoint was pharyngeal barium residue , which indicates incomplete bolus clearance , measured at week 48 by videofluorography .
METHODS	All patients who were randomly assigned and who were assessed with videofluorography at least once were included in the analyses .
METHODS	This study is registered with the JMACCT clinical trials registry , number JMA-IIA00009 , and the UMIN clinical trials registry , number UMIN000000465 .
RESULTS	204 patients were randomly assigned and 199 started treatment : 100 with leuprorelin and 99 with placebo .
RESULTS	At week 48 , the pharyngeal barium residue after initial swallowing had changed by -5.1 % ( SD 21.0 ) in the leuprorelin group and by 0.2 % ( 18.2 ) in the placebo group ( difference between groups -5.3 % ; 95 % CI -10.8 to 0.3 ; p = 0.063 ) .
RESULTS	The mean difference in pharyngeal barium residue after piecemeal deglutition at week 48 was -3.2 % ( -6.4 to 0.0 ; p = 0.049 ) , but there was no significant difference between the groups after covariate adjustment for the baseline data ( -4.1 to 1.6 ; p = 0.392 ) .
RESULTS	In a predefined subgroup analysis , leuprorelin treatment was associated with a greater reduction in barium residue after initial swallowing than was placebo in patients with a disease duration less than 10 years ( difference between groups -9.8 , -17.1 to -2.5 ; p = 0.009 ) .
RESULTS	There were no significant differences in the number of drug-related adverse events between groups ( 57 of 100 in the leuprorelin group and 54 of 99 in the placebo group ; p = 0.727 ) .
CONCLUSIONS	48 weeks of treatment with leuprorelin did not show significant effects on swallowing function in patients with spinal and bulbar muscular atrophy , although it was well tolerated .
CONCLUSIONS	Disease duration might influence the efficacy of leuprorelin and thus further clinical trials with sensitive outcome measures should be done in subpopulations of patients .
BACKGROUND	Large Scale Clinical Trial Network Project , Japan and Takeda Pharmaceuticals .

###9579432
OBJECTIVE	The purpose of this study was to determine whether magnesium sulfate given for prevention of eclampsia affected labor outcomes compared with phenytoin , which is not known to impede uterine activity when given in anticonvulsant doses .
METHODS	Secondary analysis was performed of a study of women with pregnancy-induced hypertension who were admitted for delivery and randomly assigned to receive either magnesium sulfate or phenytoin for eclampsia prophylaxis .
METHODS	Nulliparous women with a singleton pregnancy in cephalic presentation at term were selected for analysis in an effort to limit the influence of confounding variables such as preterm birth and malpresentations on labor management and outcomes .
METHODS	Similarly , women who had severe preeclampsia and who received labor epidural analgesia were excluded .
RESULTS	A total of 2138 women were randomized to receive magnesium sulfate or phenytoin in the primary study .
RESULTS	A total of 905 nulliparous women met the inclusion criteria for this secondary analysis ; 480 had been randomized to phenytoin and 425 were given magnesium sulfate .
RESULTS	The two groups were similar demographically .
RESULTS	Labor outcomes such as ( 1 ) oxytocin stimulation , ( 2 ) admission-to-delivery intervals , ( 3 ) prolonged second-stage labor , ( 4 ) forceps delivery , and ( 5 ) cesarean delivery were not affected by maternal treatment with magnesium sulfate .
CONCLUSIONS	Compared with phenytoin , magnesium sulfate given for intrapartum treatment of pregnancy-induced hypertension does not significantly affect labor outcomes .

###10172365
OBJECTIVE	To compare the haemodynamic effects of pressure-controlled ventilation ( PCV ) with volume-controlled ventilation ( VCV ) in patients after cardiac surgery .
METHODS	Prospective clinical study .
METHODS	Post-operative cardiac surgical ICU .
METHODS	Twenty sequential elective adult patients with no previous chronic lung disease and aged less than 70 years old .
METHODS	One hour after ICU admission and receiving mechanical ventilation utilising sinusoidal flow , patients were divided into two groups according to cardiac index ( CI ) : group I : CI > 2.5 l/min/M2 and group II : CI < 2.5 l/min/M2 .
METHODS	They were submitted randomly to 15 minutes ' PC or VC mode , a 30-minute wash-out period of mechanical ventilation with a sinusoidal flow pattern , and then alternate PC or VC mode for 15 more minutes .
METHODS	Data were statistically compared using analysis of variance ( ANOVA ) with a significance level of 5 % .
METHODS	Sedatives and muscle relaxants were given as necessary .
METHODS	Data were obtained at the end of 15 minutes under each ventilatory mode , observing a 30-minute interval between each .
METHODS	Standard cardiorespiratory parameters were measured or calculated using conventional monitoring ( including cardiac output ) , Qs/Qt , A-aDO2 alveolar-arterial oxygen difference , peak inspiratory pressure , mean airway pressure and dynamic compliance ( C ) .
RESULTS	No significant differences between PCV and VCV modes , or between groups , were seen in MPAP , MAP , PCWP , RAP , heart rate , O2ER , VO2I , Paw , C , A-aDO2 and Qs/Qt .
RESULTS	However , DO2I ( p = 0.0063 ) , LVSWI , ( p = 0.0001 ) and RVSWI ( p = 0.0053 ) showed a statistically significant difference between groups I and II .
RESULTS	No influence of VCV or PCV on these parameters was seen .
RESULTS	There was a slight significant difference between groups for PVR ( p = 0.0205 ) .
RESULTS	In contrast , CI ( p = 0.0001 ) and SVR ( p = 0.0062 ) showed significant differences among groups , but also a significantly favourable effect of PCV over VCV ( p = 0.0239 and p = 0.0318 respectively ) .
RESULTS	Finally , a significant reduction ( p = 0.0001 ) in peak inspiratory pressure with PCV was observed .
CONCLUSIONS	PC and VC ventilatory modes had comparable effects on patients with preserved or depressed cardiac output .
CONCLUSIONS	Patients ventilated with PCV showed significantly higher values for cardiac index , a decreased SVR , as well as significantly lower values for inspiratory pressure when compared with VCV patients .

###20406432
BACKGROUND	Previous studies have shown that acute intake of high-phenol virgin olive oil reduces pro-inflammatory , pro-oxidant and pro-thrombotic markers compared with low phenols virgin olive oil , but it still remains unclear whether effects attributed to its phenolic fraction are exerted at transcriptional level in vivo .
BACKGROUND	To achieve this goal , we aimed at identifying expression changes in genes which could be mediated by virgin olive oil phenol compounds in the human .
RESULTS	Postprandial gene expression microarray analysis was performed on peripheral blood mononuclear cells during postprandial period .
RESULTS	Two virgin olive oil-based breakfasts with high ( 398 ppm ) and low ( 70 ppm ) content of phenolic compounds were administered to 20 patients suffering from metabolic syndrome following a double-blinded , randomized , crossover design .
RESULTS	To eliminate the potential effect that might exist in their usual dietary habits , all subjects followed a similar low-fat , carbohydrate rich diet during the study period .
RESULTS	Microarray analysis identified 98 differentially expressed genes ( 79 underexpressed and 19 overexpressed ) when comparing the intake of phenol-rich olive oil with low-phenol olive oil .
RESULTS	Many of these genes seem linked to obesity , dyslipemia and type 2 diabetes mellitus .
RESULTS	Among these , several genes seem involved in inflammatory processes mediated by transcription factor NF-kappaB , activator protein-1 transcription factor complex AP-1 , cytokines , mitogen-activated protein kinases MAPKs or arachidonic acid pathways .
CONCLUSIONS	This study shows that intake of virgin olive oil based breakfast , which is rich in phenol compounds is able to repress in vivo expression of several pro-inflammatory genes , thereby switching activity of peripheral blood mononuclear cells to a less deleterious inflammatory profile .
CONCLUSIONS	These results provide at least a partial molecular basis for reduced risk of cardiovascular disease observed in Mediterranean countries , where virgin olive oil represents a main source of dietary fat .
CONCLUSIONS	Admittedly , other lifestyle factors are also likely to contribute to lowered risk of cardiovascular disease in this region .

###9671874
OBJECTIVE	To compare the efficacy of oral liarozole , the first retinoic acid metabolism-blocking agent ( RAMBA ) to be developed as differentiation therapy for human solid tumors , with that of cyproterone acetate ( CPA ) , an antiandrogen for the treatment of metastatic prostate cancer .
OBJECTIVE	Liarozole promotes differentiation of cancer cells by increasing the intratumoral levels of retinoic acid .
METHODS	A total of 321 patients with metastatic prostate cancer in relapse after first-line endocrine therapy entered a Phase III international multicenter study ( recruitment from February 1992 to August 1994 ) comparing liarozole ( 300 mg two times daily ) with CPA ( 100 mg two times daily ) .
RESULTS	Accounting for differences in baseline prognostic factors , the adjusted hazard ratio for survival was 0.74 in favor of liarozole ( P = 0.039 ) , indicating a 26 % lower risk of death than in patients treated with CPA .
RESULTS	Median crude ( unadjusted ) survival time was the same in the liarozole group as in the CPA group ( 10.3 months ) .
RESULTS	More patients showed a PSA response ( at least 50 % reduction in PSA from baseline ) when treated with liarozole ( 20 % ) than with CPA ( 4 % ) ( P < 0.001 ) .
RESULTS	Prostate-specific antigen ( PSA ) responders had a median survival benefit of 10 months over nonresponders , irrespective of treatment ( hazard ratio 0.43 ; P = 0.0018 ) .
RESULTS	PSA response was apparent within 3 months in approximately 90 % of patients who responded .
RESULTS	Pain improved more in the liarozole group than in the CPA group ( P = 0.03 ) .
RESULTS	PSA responders had lower median pain scores than nonresponders ( 1.7 versus 2.5 ) and better quality of life ( median Functional Living Index-Cancer score 108 versus 98 ) at end point , ie , treatment discontinuation , as well as throughout the treatment period .
RESULTS	Among the most frequently occurring adverse events in the liarozole group were dry skin ( 51 % of patients ) , pruritus ( 25 % ) , rash ( 16 % ) , nail disorders ( 16 % ) , and hair loss ( 15 % ) .
RESULTS	These adverse events were generally mild to moderate in severity and did not affect the overall quality of life score .
RESULTS	There were no detectable effects of either treatment on vital signs such as blood pressure , heart rate , electrocardiogram , and body weight .
CONCLUSIONS	Liarozole is superior to CPA in terms of PSA response , PSA progression , and survival , and is capable of maintaining patients ' quality of life .
CONCLUSIONS	The observed adverse events were mild to moderate in nature .
CONCLUSIONS	These results show that liarozole is a possible treatment option after first-line endocrine therapy has failed .

###20009964
BACKGROUND	Infants less than 3 months of age are at highest risk of hospitalization and death from pertussis .
BACKGROUND	Several studies have examined antibody responses to pertussis vaccines at birth but no previous study has evaluated 2 doses of monovalent acellular pertussis vaccine ( aPV ) before 2 months of age .
METHODS	Seventy-six newborns were randomized at birth to 3 groups-aPV at birth and 1 month , aPV at birth , and control .
METHODS	All infants received hepatitis B vaccine ( HBV ) at birth followed at 2 , 4 , and 6 months by a combination vaccine including aPV , diphtheria , tetanus , Haemophilus influenzae type b ( Hib ) , hepatitis B , polio antigens and 7 valent conjugate pneumococcal vaccine .
METHODS	IgG antibody responses to pertussis toxoid ( PT ) , filamentous hemagglutinin ( FHA ) , and pertactin ( PRN ) were measured in maternal serum and in infants at 2 , 4 , 6 , and 8 months of age .
METHODS	Antibody responses to hepatitis B , diphtheria , tetanus , and Hib were measured at 8 months only .
METHODS	A parental diary and active telephone follow-up occurred for 7 days after each vaccination .
RESULTS	The aPV birth dose was well tolerated .
RESULTS	By 2 months of age , 22 of 25 ( 88 % ) of 2 dose recipients had detectable IgG antibody to PT ( IgG PT ) compared with 9 of 21 ( 43 % ) who received a birth dose only and 3 of 20 ( 15 % ) of controls .
RESULTS	Infants in the 2 dose group had a geometric mean concentration ( GMC ) of IgG PT of 16 ELISA units per mL ( EU/mL ) , 95 % CI : 11 to 25 , significantly higher than birth dose only ( 5 EU/mL , 95 % CI : 3-8 ) and controls ( 3 EU/mL , 95 % CI : 2-5 ) .
RESULTS	At 8 months of age , following 5 , 4 , and 3 doses of aP-containing vaccine , respectively , IgG PT had plateaued but IgG to FHA and PRN increased with successive doses .
RESULTS	There was a trend to lower antibody responses for hepatitis B and Hib with higher numbers of Pa doses .
CONCLUSIONS	These data suggest that aPV at birth and 1 month induces significantly higher IgG antibody against pertussis antigens by 2 months of age without reducing subsequent pertussis antibody responses .
CONCLUSIONS	Larger and more detailed studies of aPV from birth are needed to evaluate other antibody responses and the potential of this approach to reduce death and morbidity from Bordetella pertussis infection in the first 3 months of life .

###21799214
BACKGROUND	The purpose of this investigation was to determine the effect of ingested caffeine , sodium bicarbonate , and their combination on 2,000-m rowing performance , as well as on induced alkalosis ( blood and urine pH and blood bicarbonate concentration [ HCO3 - ] ) , blood lactate concentration ( [ La - ] ) , gastrointestinal symptoms , and rating of perceived exertion ( RPE ) .
METHODS	In a double-blind , crossover study , 8 well-trained rowers performed 2 baseline tests and 4 2,000-m rowing-ergometer tests after ingesting 6 mg/kg caffeine , 0.3 g/kg body mass ( BM ) sodium bicarbonate , both supplements combined , or a placebo .
METHODS	Capillary blood samples were collected at preingestion , pretest , and posttest time points .
METHODS	Pairwise comparisons were made between protocols , and differences were interpreted in relation to the likelihood of exceeding the smallest worthwhile-change thresholds for each variable .
METHODS	A likelihood of > 75 % was considered a substantial change .
RESULTS	Caffeine supplementation elicited a substantial improvement in 2,000-m mean power , with mean ( SD ) values of 354 67 W vs. placebo with 346 61 W. Pretest [ HCO3 - ] reached 29.2 2.9 mmol/L with caffeine + bicarbonate and 29.1 1.9 mmol/L with bicarbonate .
RESULTS	There were substantial increases in pretest [ HCO3 - ] and pH and posttest urine pH after bicarbonate and caffeine + bicarbonate supplementation compared with placebo , but unclear performance effects .
CONCLUSIONS	Rowers ' performance in 2,000-m efforts can improve by ~ 2 % with 6 mg/kg BM caffeine supplementation .
CONCLUSIONS	When caffeine is combined with sodium bicarbonate , gastrointestinal symptoms may prevent performance enhancement , so further investigation of ingestion protocols that minimize side effects is required .

###24179072
OBJECTIVE	Cardiac conduction disturbances , including a left bundle branch block ( LBBB ) , occur frequently following transcatheter aortic valve replacement ( TAVR ) and may be associated with adverse clinical events .
OBJECTIVE	This analysis examines the incidence and implications of new onset , persistent LBBB in patients undergoing TAVR with a balloon-expandable valve .
RESULTS	Patients undergoing TAVR in the Placement of Aortic Transcatheter Valves ( PARTNER ) trial and continued access registries with baseline and discharge/7-day electrocardiograms were included .
RESULTS	Prior permanent pacemaker implantation ( PPI ) and baseline intraventricular conduction abnormalities were exclusion criteria .
RESULTS	Predictors of new LBBB were identified and outcomes compared between patients with and without new LBBB .
RESULTS	New LBBB occurred in 121 of 1151 ( 10.5 % ) patients and persisted in more than half at 6 months to 1 year .
RESULTS	The only predictor of new LBBB was prior coronary artery bypass grafting .
RESULTS	New LBBB was not associated with significant differences in 1-year mortality , cardiovascular mortality , repeat hospitalization , stroke , or myocardial infarction .
RESULTS	However , it was associated with increased PPI during hospitalization ( 8.3 vs 2.8 % , P = 0.005 ) and from discharge to 1 year ( 4.7 vs. 1.5 % , P = 0.01 ) .
RESULTS	The ejection fraction failed to improve after TAVR in patients with new LBBB and remained lower at 6 months to 1 year ( 52.8 vs. 58.1 % , P < 0.001 ) .
CONCLUSIONS	Persistent , new-onset LBBB occurred in 10.5 % of patients without intraventricular baseline conduction who underwent TAVR in the PARTNER experience .
CONCLUSIONS	New LBBB was not associated with death , repeat hospitalization , stroke , or myocardial infarction at 1 year , but was associated with a higher rate of PPI and failure of left ventricular ejection fraction to improve .

###19832806
OBJECTIVE	To assess the efficacy and tolerability of asenapine versus olanzapine in the extended treatment of bipolar mania .
METHODS	Patients with bipolar I disorder experiencing acute manic or mixed episodes who completed either of two 3-week , double-blind trials with asenapine 5 or 10 mg twice daily , olanzapine 5 to 20 mg once daily , or placebo were eligible for this 9-week , double-blind extension study .
METHODS	Patients receiving active medication in the 3-week trials continued the same regimen ; those who had received placebo were blindly switched to asenapine but were assessed for safety outcomes only .
METHODS	The primary efficacy measure was the change from baseline to day 84 on the Young Mania Rating Scale ( YMRS ) total score in the per-protocol population .
METHODS	Results on the primary efficacy outcome were used to determine the noninferiority of asenapine versus olanzapine .
RESULTS	A total of 504 patients ( placebo/asenapine , n = 94 ; asenapine , n = 181 ; olanzapine , n = 229 ) were enrolled in the extension study .
RESULTS	At day 84 , the mean ( SD ) change from baseline in YMRS total score was -24.4 ( 8.7 ) for asenapine and -23.9 ( 7.9 ) for olanzapine .
RESULTS	Prespecified statistical analysis for noninferiority indicated no significant difference between asenapine and olanzapine .
RESULTS	The overall incidence of treatment-emergent adverse events was similar across treatment groups ( 77 % placebo/asenapine , 77 % asenapine , 78 % olanzapine ) .
RESULTS	Clinically significant weight gain occurred in 10 % , 19 % , and 31 % of the placebo/asenapine , asenapine , and olanzapine groups , respectively .
CONCLUSIONS	Asenapine was efficacious , showed noninferiority to olanzapine , and was well tolerated in the extended treatment of patients experiencing manic symptoms associated with bipolar I disorder .

###17681110
OBJECTIVE	Sensory testing has been advocated for the diagnosis , prognosis , and outcome evaluation of pain patients , but responses to controlled stimuli have not been well correlated to clinical pain .
OBJECTIVE	As an initial step for improving the clinical relevance of sensory testing , this investigation compared appraisals of and responses to controlled pain stimuli .
METHODS	A prospective within subjects design was used .
METHODS	Heat , ischaemic , and delayed-onset muscle pain were induced in the upper extremity of 44 participants ( 47.7 % women ) during four experimental sessions .
RESULTS	The threat of heat and ischaemic pain was higher than delayed-onset muscle pain ( F ( 2,86 ) = 5.30 , p < .01 , eta ( 2 ) = .11 ) .
RESULTS	Threat , challenge , predictability , and controllability were related to heat pain most consistently .
RESULTS	The affective-sensory ratios of ischaemic and delayed-onset muscle pain resembled those of clinical pain and were higher than heat pain ( F ( 2,84 ) = 11.64 , p < .01 , eta ( 2 ) = .22 ) .
RESULTS	Delayed-onset muscle pain meaningfully affected daily activities , which correlated to delayed-onset muscle pain ratings ( rs = .60 -.68 , ps < .001 ) .
CONCLUSIONS	Heat stimuli may be well suited for instructional manipulations of appraisals to improve the clinical relevance of quantitative sensory testing and delayed-onset muscle pain 's effects on daily activities are clinically relevant .

###22998687
BACKGROUND	Sustained acid inhibition with PPI stimulates gastrin secretion , exerting a proliferative drive on enterochromaffin-like cells ( ECL cells ) of the oxyntic mucosa .
BACKGROUND	It may also accelerate development of gastric gland atrophy in Helicobacter pylori-infected individuals .
OBJECTIVE	To evaluate gastric exocrine and endocrine cell changes in GERD patients randomised to laparoscopic antireflux surgery ( LARS , n = 288 ) or long-term ( 5 years ) esomeprazole ( ESO ) treatment ( n = 266 ) .
METHODS	Antral and corpus biopsies were taken at endoscopy and serum gastrin and chromogranin A levels were assayed , at baseline and after 1 , 3 and 5 years ' therapy .
RESULTS	Biopsies were available at each time point for 158 LARS patients and 180 ESO patients .
RESULTS	In H. pylori-infected subjects , antral mucosal inflammation and activity improved significantly ( P < 0.001 ) and stabilised after 3 years on esomeprazole while no change in inflammation was observed after LARS .
RESULTS	Oxyntic mucosal inflammation and activity remained stable on esomeprazole but decreased slightly over time after LARS .
RESULTS	Neither intestinal metaplasia nor atrophy developed in the oxyntic mucosa .
RESULTS	ECL cell density increased significantly after ESO ( P < 0.001 ) , corresponding with an increase in circulating gastrin and chromogranin A.
RESULTS	After LARS , there was a significant decrease in ECL cell density ( P < 0.05 ) , accompanied by a marginal decrease in gastrin and chromogranin .
CONCLUSIONS	Antral gastritis improved in H. pylori-infected GERD patients after 5 years on esomeprazole , with little change in laparoscopic antireflux surgery patients , who acted as a control .
CONCLUSIONS	Despite a continued proliferative drive on enterochromaffin-like cells during esomeprazole treatment , no dysplastic or neoplastic lesions were found and no safety concerns were raised .
CONCLUSIONS	NCT 00251927 .

###21775558
BACKGROUND	Despite the reported benefits , weight loss is not always advised for older adults because some observational studies have associated weight loss with increased mortality .
BACKGROUND	However , the distinction between intentional and unintentional weight loss is difficult to make in an observational context , so the effect of intentional weight loss on mortality may be clarified in the setting of a randomized controlled trial .
OBJECTIVE	The objective was to determine the effect of intentional weight loss on all-cause mortality by using follow-up data from a randomized trial completed in 1995 that included a weight-loss arm .
METHODS	The Trial of Nonpharmacologic Intervention in the Elderly ( TONE ) used a 2 2 factorial design to determine the effect of dietary weight loss , sodium restriction , or both on blood pressure control in 585 overweight or obese older adults being treated for hypertension ( mean SD age : 66 4 y ; 53 % female ) .
METHODS	All-cause mortality was ascertained by using the Social Security Index and National Death Index through 2006 .
RESULTS	The mortality rate of those who were randomly assigned to the weight-loss intervention ( n = 291 ; mean weight loss : 4.4 kg ) did not differ significantly from that of those who were not randomly assigned to this group ( n = 294 ; mean weight loss : 0.8 kg ) .
RESULTS	The adjusted HR was 0.82 ( 95 % CI : 0.55 , 1.22 ) .
CONCLUSIONS	Intentional dietary weight loss was not significantly associated with increased all-cause mortality over 12 y of follow-up in older overweight or obese adults .
CONCLUSIONS	Additional studies are needed to confirm and extend our findings to older age groups .
CONCLUSIONS	This trial is registered at clinicaltrials.gov as NCT00000535 .

###16732085
BACKGROUND	Upper airway obstruction ( UAO ) during sedation can often cause clinically significant adverse events .
BACKGROUND	Direct comparison of different drugs ' propensities for UAO may improve selection of appropriate sedating agents .
BACKGROUND	The authors used the application of negative airway pressure to determine the pressure that causes UAO in healthy subjects sedated with midazolam or propofol infusions .
METHODS	Twenty subjects ( 12 male and 8 female ) completed the study .
METHODS	After achieving equivalent levels of sedation , the subjects ' ventilation , end-tidal gases , respiratory inductance plethysmographic signals , and Bispectral Index values were monitored for 5 min .
METHODS	Negative airway pressure was then applied via a facemask in steps of 3 cm H ( 2 ) O from -3 to -18 cm H ( 2 ) O. UAO was assessed by cessation of inspiratory airflow and asynchrony between abdomen and chest respiratory inductance plethysmographic signals .
RESULTS	Equivalent levels of sedation were achieved with both drugs with average ( + / - SD ) Bispectral Index levels of 75 + / - 5 .
RESULTS	Resting ventilation was mildly reduced without any changes in end-tidal pressure of carbon dioxide .
RESULTS	There was no difference between the drugs in the negative pressure resulting in UAO .
RESULTS	Five female subjects and one male subject with midazolam and four female subjects and one male subject with propofol did not show any UAO even at -18 cm H ( 2 ) O. Compared with males , female subjects required more negative pressures to cause UAO with midazolam ( P = 0.02 ) but not with propofol ( P = 0.1 ) .
CONCLUSIONS	At the mild to moderate level of sedation studied , midazolam and propofol sedation resulted in the same propensity for UAO .
CONCLUSIONS	In this homogeneous group of healthy subjects , there was a considerable range of negative pressures required to cause UAO .
CONCLUSIONS	The specific factors responsible for the maintenance of the upper airway during sedation remain to be elucidated .

###10441239
OBJECTIVE	This study with 31 obese binge eaters ( body mass index [ BMI ] 39.5 + / -8.6 kg/m ( 2 ) [ SD ] ) was designed to assess whether diet counseling with psychological support and imipramine or placebo has an effect on the frequency of binge eating , body weight , and depression during an 8-week treatment phase .
OBJECTIVE	This was followed by an open medication-free phase of 6 months of continuous diet counseling with psychological support .
METHODS	Randomized double-blind placebo-controlled study of 8 weeks followed by an open phase of 6 months .
METHODS	Patients were evaluated in medical visits by a semistructured videotaped interview , psychometric questionnaires , and hematochemical parameters .
RESULTS	From Week 0 to 8 , a significant reduction in binge frequency occurred in both treatment conditions ( 7.1 + / -4.1 to 2.8 + / -3.0 binges per week [ imipramine ] vs. 7.1 + / -4.1 to 5.4 + / -5.1 [ placebo ] , p < .01 ) .
RESULTS	Patients on imipramine lost -2.2 + / -1.8 kg compared to placebo-treated subjects ( +0.2 + / -3.3 kg , p < .001 ) .
RESULTS	On follow-up , only the patients initially treated with imipramine continued to lose weight ( -5.1 + / -2.8 kg [ imipramine ] vs. 2.2 + / -6.8 kg [ placebo ] , p < .001 [ differences to Week 0 ] ) .
RESULTS	While both treatment conditions were associated with significant improvements on a rater 's measure of depressive symptoms ( Hamilton Depression Scale ) at Week 8 , only the patients treated with imipramine still showed a significant improvement at Week 32 .
RESULTS	Scores on the Self Depression Rating Scale did not show a group difference but a significant reduction at Weeks 8 and 32 , compared to baseline .
CONCLUSIONS	These results suggest that adding low-dose imipramine to diet counseling with psychological support helps patients losing weight even for at least 6 months off medication .
CONCLUSIONS	The effect might include a psychological priming of weight loss during the double-blind phase that continues at least for half a year after stopping the drug .

###23733529
BACKGROUND	Duloxetine has been studied in four distinct chronic pain conditions - osteoarthritis ( OA ) , fibromyalgia , chronic low back pain ( CLBP ) and diabetic peripheral neuropathic pain ( DPNP ) .
BACKGROUND	These trials have involved large numbers of patients with at least moderate pain , and have used similar methods for recording pain intensity , over about 12 weeks .
METHODS	Data from the trials were pooled according to painful condition , and reanalysed at the level of the individual patient and using increasing levels of pain intensity reduction ( < 15 % , 15-29 % , 30-49 % , 50 % ) , with different imputation methods on withdrawal .
RESULTS	The proportion of patients recording at least 50 % pain intensity reduction plateaued after 2-6 weeks in fibromyalgia , and 8-12 weeks in other conditions .
RESULTS	The duloxetine-specific benefit [ number needed to treat ( NNT ) for at least 50 % pain intensity reduction ] was fairly constant after about 2 weeks for DPNP and fibromyalgia and after about 4 or 5 weeks for OA and CLBP .
RESULTS	In all conditions , responses were bimodal , with patients generally experiencing either very good or very poor pain relief .
RESULTS	Last-observation-carried-forward imputation produced numerically and occasionally statistically better ( lower ) NNTs than use of baseline-observation-carried-forward ( true response ) .
CONCLUSIONS	Baseline-observation-carried-forward ( true response ) , which combines the success of high levels of pain relief with the failure to experience pain relief on withdrawal of the drug is conservative and probably reflective of clinical practice experience .
CONCLUSIONS	The distribution of effect was not normal ; few patients had the average response and averages are not an appropriate descriptor for these data .

###12167681
BACKGROUND	Spasticity is a disabling complication of stroke , and it is uncertain whether intramuscular injections of botulinum toxin type A reduce disability in persons with spasticity of the wrist and fingers after a stroke .
METHODS	We performed a randomized , double-blind , placebo-controlled , multicenter trial to assess the efficacy and safety of one-time injections of botulinum toxin A ( 200 to 240 units ) in 126 subjects with increased flexor tone in the wrist and fingers after a stroke .
METHODS	The primary outcome measure was self-reported disability in four areas : personal hygiene , dressing , pain , and limb position ( on a four-point scale ranging from no disability to severe disability ) at six weeks ; at base line , each subject selected one of these areas in which there was moderate-to-severe disability as the principal target of treatment .
RESULTS	Subjects who received botulinum toxin A had greater improvement in flexor tone in the wrist and fingers at all follow-up visits through 12 weeks than did subjects who received placebo ( P < 0.001 for all comparisons ) .
RESULTS	Subjects treated with botulinum toxin A had greater improvement in the principal target of treatment at weeks 4 , 6 , 8 , and 12 ( P < 0.001 , P < 0.001 , P = 0.03 , and P = 0.02 , respectively ) ; at week 6 , 40 of the 64 subjects in the botulinum-toxin group ( 62 percent ) , as compared with 17 of the 62 in the placebo group ( 27 percent ) , reported improvement of at least one point on the Disability Assessment Scale in the principal target of treatment ( P < 0.001 ) .
RESULTS	There were no major adverse events associated with injection of botulinum toxin A.
CONCLUSIONS	Intramuscular injections of botulinum toxin A reduce spasticity of the wrist and finger muscles and associated disability in patients who have had a stroke .

###12527617
OBJECTIVE	To compare a new transport ventilator to manual ventilation in terms of maintaining the respiratory and hemodynamic levels of critically ill patients .
METHODS	Prospective , randomized , single-center study .
METHODS	ICU in a university hospital .
METHODS	A total of 16 patients ( 22 transports ) who were spontaneously breathing and required ventilatory assistance on excursions from the ICU .
METHODS	For each transport , the patient was randomly assigned to receive either manual ventilation ( group M ) or mechanical ventilation ( group V ) .
METHODS	For transports in group V , the ventilators were set the same as in the ICU .
METHODS	Respiratory and hemodynamic variables were measured 30 min before transport ( T ( 0 ) ) , on arrival at the site of procedure ( T ( 1 ) ) , on return to the ICU ( T ( 2 ) ) , and 30 min after return the ICU ( T ( 3 ) ) .
RESULTS	After transport , five patients in group M showed a significant deterioration in PaO ( 2 ) / fraction of inspired oxygen ratio , while one patient in group V showed deterioration ( p = 0.056 ) .
RESULTS	The mean ( + / - SD ) respiratory rate in group M at T ( 2 ) ( 32 + / - 9 breaths/min ) was significantly higher ( p < 0.001 ) than at T ( 0 ) ( 19 + / - 6 breaths/min ) and also was higher ( p < 0.01 ) than in group V at T ( 2 ) ( 19 + / - 6 breaths/min ) .
RESULTS	The mean tidal volume and positive end-expiratory pressure in group M at T ( 2 ) showed significantly larger variation ( p < 0.05 and p < 0.001 , respectively ) than in group V.
CONCLUSIONS	The transport ventilator that was recently approved by the US Food and Drug Administration reliably provides more stable ventilatory support than does manual ventilation .
CONCLUSIONS	Generally , the use of this transport ventilator for intrahospital transport is preferable to manual ventilation .

###15156418
OBJECTIVE	In the cataract surgery the problems of anaesthesia in ophthalmo-surgery and anaesthesia in elderly people are combined .
OBJECTIVE	For this patients we compared intravenous anaesthesia with balanced anaesthesia in cardiac and circulatory side effects ( security ) , patients satisfaction and costs .
METHODS	In a prospective , randomised study we compared in 52 ( 26 vs. 26 ) elderly patients ( ASA II and III , mean age 78.7 + / - 8.6 years ) undergoing a cataract operation cardiac and circulatory side effects , recovery time and patients satisfaction with the either type of anaesthesia by a score from 1 = best to 6 = worse and the occurrence of nausea/vomiting ( controlled 24 h ) .
METHODS	The difference in costs were measured by the hospital management .
RESULTS	Cardiac and circulatory side effects with hypotonic reactions were similar in both groups ( TIVA 18 = 69.2 % / BA 20 = 76.9 % ) .
RESULTS	Hypertonic reactions were mainly seen in BA ( Tiva 1.9 % , BA 69.2 % / p < 0,001 ) .
RESULTS	There was no problem in the treatment of these side-effects .
RESULTS	The frequency of postoperative nausea and vomiting was lower ( but not significantly ) in the TIVA group ( TIVA 8 % / BA 27 % ) than in the BA group ( 7 and 4 ) .
RESULTS	The recovery times were shorter ( p < 0.001 ) in TIVA , those patients were staying 24 ( + / - 6.70 ) minutes in the post operative unit vs. 59 ( + / - 28.83 ) minutes in BA .
RESULTS	Patients satisfaction was better in the TIVA-group ( 1.65 ) than in the patients treated with BA .
RESULTS	In the calculation of costs there was a disadvantage in BA .
CONCLUSIONS	This study showed , that in respect of cardiac and respiratory side effects TIVA and BA are safe methods in anaesthesia for elderly people in ophthalmic surgery .
CONCLUSIONS	Nevertheless , because of shorter recovery-times , lower incidence of hypertonic reactiones , more patients satisfaction and lower costs TIVA had better results in this study .
CONCLUSIONS	We have to ask for the evaluation of economy in anaesthesia that not only prices of medicaments but the complete costs of the cases have to be calculated .

###24498399
OBJECTIVE	The Low Molecular Weight Fraction of 5 % human serum Albumin ( LMWF-5A ) is being investigated as a treatment for knee pain from osteoarthritis .
METHODS	This was a multicenter randomized , vehicle-controlled , double-blind , parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A .
METHODS	Patients with symptomatic knee osteoarthritis were randomized 1111 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control ( saline ) .
METHODS	The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities ( WOMAC ) pain change from baseline over 12 weeks .
METHODS	Safety was examined as the incidence and severity of adverse events ( AEs ) .
RESULTS	A total of 329 patients were randomized and received treatment .
RESULTS	LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control ( -0.93 vs -0.72 ; estimated difference from control : -0.25 , p = 0.004 ) ; an injection volume effect was not observed ( p = 0.64 ) .
RESULTS	The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA ( Kellgren Lawrence Grade IV ) : the estimated difference from control was -0.42 ( p = 0.02 ) .
RESULTS	Adverse events were generally mild and were similar in patients who received vehicle control ( 47 % ) and LMWF-5A ( 41 % ) .
CONCLUSIONS	This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee .
BACKGROUND	ClinicalTrials.gov NCT01839331 .

###17394534
OBJECTIVE	To compare effects of early insulin vs. glibenclamide treatment on beta-cell function , metabolic control and quality of life ( QL ) in recently diagnosed patients with type 2 diabetes .
METHODS	Forty-nine patients with type 2 diabetes diagnosed 0-2 years before inclusion were randomized to two daily injections of premixed 30 % soluble and 70 % NPH insulin or glibenclamide at six diabetic clinics in Sweden .
METHODS	C-peptide-glucagon tests were performed yearly after 3 days of withdrawal of treatment .
RESULTS	Thirty-four patients completed 4 years of study .
RESULTS	Daily dose of insulin was increased from 20.4 + / - 1.8 U at year 1 to 26.1 + / - 2.9 U at year 4 ( p = 0.005 ) .
RESULTS	Glibenclamide dosage increased from 2.7 + / - 0.4 mg at year 1 to 4.5 + / - 0.8 mg at year 4 ( p = 0.02 ) .
RESULTS	Weight increased more in insulin than in glibenclamide treated ( +4.4 + / - 0.8 vs. +0.3 + / - 1.0 kg , p < 0.005 ) .
RESULTS	Following short-term withdrawal of treatment , the C-peptide responses to glucagon were significantly higher in the insulin vs. glibenclamide group at years 1 ( p < 0.01 ) and 2 ( p < 0.02 ) .
RESULTS	HbA1c improved identical during the first year but thereafter deteriorated in the glibenclamide group ( p < 0.005 for difference at year 4 ) .
RESULTS	Ratios of proinsulin to insulin were higher during treatment in glibenclamide - vs. insulin-treated patients after year 2 .
RESULTS	QL after 4 years as measured by the MOS 36-item Short-Form Health Survey ( SF-36 ) form was not significantly altered .
CONCLUSIONS	In a 4-year perspective , beta-cell function deteriorated in both groups .
CONCLUSIONS	However , deterioration occurred faster in the glibenclamide group , indicating that alleviating demands on secretion by insulin treatment is beneficial .

###22832022
BACKGROUND	The ability to remember future intentions is compromised in both healthy and cognitively impaired older adults .
BACKGROUND	Assistive technology provides older adults with promising solutions to cope with this age-related problem .
BACKGROUND	However , the effectiveness and efficiency of such systems as memory aids is seldom evaluated in controlled , randomized trials .
OBJECTIVE	We evaluated the effectiveness of a memory aid system , the InBad ( engl .
OBJECTIVE	InBath ) , for bathroom-related daily care .
OBJECTIVE	Conceptually , the InBad learns user behavior patterns and detects deviations from the learned pattern in order to notify the user of a forgotten task .
METHODS	We simulated a challenging morning routine consisting of 22 bathroom activities with a sample of 60 healthy older adults .
METHODS	Participants were randomly assigned to three groups : ( 1 ) ` no memory support ' , i.e. , participants received no support at all , ( 2 ) ` list support ' , i.e. , participants could retrieve a list of all activities , and ( 3 ) ` system support ' , i.e. , participants received prompts for specific activities that had not yet been executed .
RESULTS	Both support groups executed significantly more activities compared to the ` no support ' group .
RESULTS	In addition , system support resulted in significantly better performance compared to list support with no significant differences between the two groups in overall task duration .
CONCLUSIONS	The assistive support system was the most effective and efficient memory aid .
CONCLUSIONS	The results suggest that assistive technology has the potential to enable older adults to remain safe and independent in their own home .

###23073338
OBJECTIVE	To investigate if anatomical characteristics of eyes undergoing ranibizumab therapy were predictive of best-corrected visual acuity ( BCVA ) outcomes over 2 years .
METHODS	Post hoc analyses of patients with age-related macular degeneration from PIER studies , defined by fundus fluorescein angiography , quantitative optical coherence tomography ( OCT ) , and qualitative OCT , were performed to determine if associations with BCVA outcomes could be found .
RESULTS	Ranibizumab-treated subgroups defined by baseline fundus fluorescein angiography lesion size and composition did not differ in BCVA outcomes at month 24 ( P = 0.13-1 .0 ) .
RESULTS	Inactivity on fundus fluorescein angiography at month 3 was associated with a 12-letter gain by month 12 ( P < 0.01 ) , whereas inactivity on month 3 qualitative OCT was not ( P > 0.05 ) .
RESULTS	Qualitative OCT inactivity at month 5 and separately at month 8 was associated with greater BCVA gains by month 24 ( 7.1 and 9.5 letters , respectively ; P 0.045 ) versus eyes with OCT activity .
CONCLUSIONS	When assessed separately , eyes with qualitative OCT ( Months 5 and 8 ) or fundus fluorescein angiography ( months 3 and 5 ) inactivity maintained vision gain from baseline at month 24 , while those with leakage not only lost initial vision gains achieved by intraocular ranibizumab but also had net vision losses from baseline at month 24 .
CONCLUSIONS	The PIER infrequent dosing regimen likely exaggerated and accelerated the deleterious effects of retinal fluid on BCVA , and it is not known whether these findings are applicable to treatment regimens that use more frequent monitoring and dosing of ranibizumab .

###15888152
BACKGROUND	Psoriasis is a chronic disease that significantly diminishes the health-related quality of life ( HRQOL ) .
BACKGROUND	Infliximab is a chimeric , tumour necrosis factor alpha monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis .
OBJECTIVE	The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis .
METHODS	In this double-blind , placebo-controlled trial , 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg ( -1 ) of infliximab or placebo and were treated at weeks 0 , 2 and 6 .
METHODS	Patients completed the Dermatology Life Quality Index ( DLQI ) at baseline and week 10 .
RESULTS	Infliximab induction therapy resulted in a substantial improvement in HRQOL .
RESULTS	At week 10 , patients in the infliximab 3 - and 5-mg kg ( -1 ) groups showed a median percentage improvement in DLQI scores of 84.0 % and 91.0 % , respectively , compared with 0 % in the placebo group ( P < 0.001 ) .
RESULTS	The median decrease from baseline in DLQI score at week 10 was 8.0 and 10.0 for the 3 and 5 mg kg ( -1 ) infliximab groups , respectively , compared with 0 in the placebo group ( P < 0.001 ) .
RESULTS	Thirty-three per cent and 40 % of patients in the 3 and 5 mg kg ( -1 ) infliximab groups , respectively , had a DLQI score of 0 at week 10 , compared with 2 % in the placebo group ( P < 0.001 ) .
RESULTS	There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index ( PASI ) scores and the percentage change in DLQI scores during the same period ( Spearman 's correlation , 0.61 , P < 0.001 ) .
RESULTS	When the infliximab and placebo treatment groups were combined , patients with at least 75 % improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores ( 81 % ) than those with 50-75 % improvement in PASI during the same period ( 60 % ) .
CONCLUSIONS	Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis .

###17594774
OBJECTIVE	Despite the known effects of stigma on people suffering from affective disorders , no study so far has investigated and compared attitudes of the general public towards depression and mania .
OBJECTIVE	Furthermore , we were interested if it makes a difference if one asks a sample about its own attitudes or the assumed opinions of ` others ' .
METHODS	We used an experimental and randomized design .
METHODS	People were faced either with a case vignette describing a man with current symptoms of depression or mania .
METHODS	Randomly people ( N = 387 , age 16-34 years ) were asked for their own attitudes or for the attitudes of the public in general .
RESULTS	Attitudes towards an individual with a current manic episode turned out to be significantly more negative than towards a person with current depression .
RESULTS	Interestingly , the attitudes of the general public were reported to be more negative than the personal attitudes .
CONCLUSIONS	While depression is still associated with negative attitudes , this first study looking at manic symptoms as well finds that this seems to be even more so for manic episodes indicating bipolar disorder .
CONCLUSIONS	It seems recommended to concentrate efforts to reduce stigmatization of the mentally ill more intensively on the bipolar spectrum of affective disorders .
CONCLUSIONS	Furthermore , testable hypotheses have to be derived why individuals attribute less favourable attitudes to the general public when compared with their own attitudes .
CONCLUSIONS	The question is if there is a general bias towards social desirability when people are asked for their opinion .

###15220014
BACKGROUND	Tigecycline is a broad-spectrum glycylcycline antibiotic being investigated for the treatment of serious infections in hospitalized patients .
BACKGROUND	Tigecycline has been shown to be efficacious against serious infections in animals , and preliminary studies in healthy adults have shown that tigecycline has an acceptable tolerability profile .
OBJECTIVE	This study compared the clinical and microbiological efficacy , pharmacokinetic properties , and tolerability of 2 doses of tigecycline in hospitalized patients with a complicated skin and skin-structure infection ( cSSSI ) .
METHODS	This Phase II , randomized , open-label study was conducted between September 1999 and March 2001 at 14 investigative centers across the United States .
METHODS	Patients were randomized to receive tigecycline 25 or 50 mg IV q12h for 7 to 14 days .
METHODS	The primary efficacy end point was the clinically observed cure rate among clinically evaluable ( CE ) patients at the test-of-cure visit .
METHODS	Secondary end points were the clinical cure rate at the end of treatment and bacteriologic response in microbiologically evaluable ( ME ) patients .
METHODS	Also , in vitro tests of susceptibility to tigecycline were performed for selected pathogens known to cause skin infections , including methicillin-resistant and methicillin-susceptible Streptococcus pyogenes , Staphylococcus aureus , Escherichia coli , Enterococcus faecalis , and Enterococcus faecium .
METHODS	Tolerability assessments also were conducted .
RESULTS	A total of 160 patients received > or = 1 dose of tigecycline ; 109 patients were CE , and 91 were ME .
RESULTS	The majority of patients ( 74 % ) were men , and the mean ( SD ) age was 49.0 ( 14.8 ) years .
RESULTS	At the test-of-cure visit , the clinical cure rate in the 25-mg group was 67 % ( 95 % CI , 53.3 % -79.3 % ) and in the 50-mg group was 74 % ( 95 % CI , 60.3 % -85.0 % ) .
RESULTS	In the 25-mg group , 56 % of the patients had eradication ( 95 % CI , 40.0 % -70.4 % ) of the pathogens compared with 69 % ( 95 % CI , 54.2 % -82.3 % ) in the 50-mg group .
RESULTS	Values for the minimum concentration of tigecycline that is inhibitory for 90 % of all isolates ranged from 0.06 to 0.50 microg/mL for the selected pathogens .
RESULTS	Both tigecycline doses were generally well tolerated .
RESULTS	Nausea and vomiting were the most common adverse events .
CONCLUSIONS	In this study , tigecycline appeared efficacious and showed a favorable pharmacokinetic profile and an acceptable safety profile in the treatment of hospitalized patients with cSSSI .
CONCLUSIONS	In patients who received 50-mg doses of tigecycline q12h , the clinical cure rates and microbial eradication rates were 74 % and 70 % , respectively , and were 67 % and 56 % in patients who received 25-mg doses .

###12034943
OBJECTIVE	To determine the effectiveness of magnetic resonance ( MR ) imaging in the appropriate identification of those patients with a high clinical suspicion of internal derangements of the knee who require arthroscopic therapy .
METHODS	In a prospective multicenter study , MR imaging was performed at 0.5 T in 430 consecutive patients .
METHODS	The sensitivity and specificity of MR imaging in the patients who underwent arthroscopy and the corrected sensitivity and specificity of MR in all the study patients were calculated .
METHODS	For this correction , patients with negative MR and arthroscopic results were considered representative of the patients with negative MR results who were conservatively treated , and the number of the former was doubled .
METHODS	The standard errors of the corrected values were adjusted with the delta method .
RESULTS	At MR imaging , arthroscopy was indicated in 221 patients , 200 of whom underwent arthroscopy .
RESULTS	Two hundred nine patients with negative MR imaging results were randomized for arthroscopic ( 105 patients ) or for conservative treatment ( 104 patients ) .
RESULTS	Of the 105 patients randomized for arthroscopy , 93 actually underwent arthroscopy .
RESULTS	Arthroscopic treatment was necessary in 13 of 93 patients with a negative diagnosis at MR imaging .
RESULTS	Arthroscopic treatment was necessary in 179 of 200 patients with a positive diagnosis at MR ( sensitivity , 93.2 % ; specificity , 79.2 % ) .
RESULTS	Sensitivity and specificity corrected for randomization were 87.3 % and 88.4 % .
RESULTS	Sensitivity and specificity corrected for randomization , respectively , were 84.1 % and 94.2 % for the diagnosis of medial meniscal tears and 69.5 % and 94.5 % for the diagnosis of lateral meniscal tears at MR.
CONCLUSIONS	MR imaging is an effective tool in the selection of patients for arthroscopy from among a general population .

###22159017
OBJECTIVE	Although trachoma control programs frequently use the World Health Organization ( WHO ) simplified grading system for trachoma to monitor the clinical response after repeated mass azithromycin treatments , the programmatic relevance of this evaluation after multiple rounds of antibiotic treatments is unclear .
METHODS	Three rounds of annual mass azithromycin were distributed to 12 villages in Ethiopia .
METHODS	Twelve months after the third treatment , children were assessed for follicular trachomatous inflammation ( TF ) and intense trachomatous inflammation ( TI ) using the WHO simplified grading system and for ocular chlamydial infection using DNA-based and RNA-based tests .
METHODS	Test characteristics for predicting chlamydial infection were computed assuming a chlamydial RNA-based gold standard .
METHODS	As a secondary analysis , test characteristics were also assessed using a latent class analysis .
RESULTS	The prevalence of RNA evidence of ocular chlamydia was 7.1 % ( 95 % confidence interval [ CI ] , 2.7-17 .4 ) .
RESULTS	A DNA-based test and TF had sensitivities of 61.0 % ( 95 % CI , 47.1-73 .3 ) and 65.9 % ( 95 % CI , 41.6-83 .9 ) , specificities of 100 % ( 95 % CI , 99.3-100 ) and 67.5 % ( 95 % CI , 61.0-73 .5 ) , and positive predictive values of 100 % ( 95 % CI , 86.3-100 ) and 13.4 % ( 95 % CI , 5.5-29 .3 ) compared with an RNA-based gold standard .
RESULTS	The latent class analysis confirmed that the RNA-based test was a reasonable choice for a gold standard , with a sensitivity of 100 % ( 95 % CI , 67.1-100 ) and specificity of 99.6 % ( 95 % CI , 98.1-100 ) .
CONCLUSIONS	Basing treatment decisions after mass azithromycin distributions on the WHO simplified grading system will maximize the treatment of infected persons compared with a DNA-based test but will also result in more uninfected persons being treated .
CONCLUSIONS	The RNA-based test was considerably more sensitive , and almost equivalently specific , compared with a DNA-based test .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00322972 . )

###21236408
OBJECTIVE	To evaluate wound architectures of a clear corneal incision and the duration of stromal edema caused by intentional hydration in cataract surgery using 3-dimensional ( 3-D ) cornea and anterior segment optical coherence tomography ( OCT ) .
METHODS	Prospective , randomized study .
METHODS	On 30 eyes of 23 patients , cataract surgery was performed through a clear corneal incision created with a 2.4-mm blade .
METHODS	After confirming the water tightness of the clear corneal incision at the end of surgery , 15 randomly selected eyes received stromal hydration , and the remaining 15 eyes did not .
METHODS	Using the 3-D cornea and anterior segment optical coherence tomography , wound architecture was assessed 1 day , 1 week , and 2 weeks after surgery .
RESULTS	There was a statistically significant difference in corneal thickness at the clear corneal incision between eyes with and without stromal hydration 1 day and 1 week after surgery ( P < .001 and P < .05 , Mann-Whitney U test ) , but not at 2 weeks after surgery .
RESULTS	On day 1 , gaping at the epithelial side was seen in 6.7 % ( 2 eyes ) , gaping at the endothelial side in 30 % ( 9 eyes ) , misalignment of the roof and floor of incision in 40 % ( 12 eyes ) , and local detachment of Descemet membrane in 36.7 % ( 11 eyes ) .
RESULTS	These imperfections improved with time .
CONCLUSIONS	Using the 3-D cornea and anterior segment optical coherence tomography , detailed architectures of the clear corneal incision were investigated .
CONCLUSIONS	It was found that the effect of stromal hydration lasted for at least 1 week after surgery .

###8986186
BACKGROUND	Nonsteroidal anti-inflammatory drugs have been documented to be effective in the treatment of postoperative pain .
BACKGROUND	The aim of this study was to evaluate the analgesic effect of local intra-articular injection of tenoxicam compared with intravenous injection on postoperative pain after arthroscopy .
METHODS	After day-case arthroscopy , 60 patients were randomized to receive either tenoxicam 20 mg in 20 ml of normal saline intra-articularly and 2 ml of normal saline i.v. , or 20 ml of normal saline intra-articularly and 2 ml tenoxicam 20 mg i.v. Postoperative pain was assessed using a visual analogue scale and measuring analgesic requirements .
RESULTS	Pain scores were significantly lower in the intra-articular group at rest and during active flexion of the knee at 1 , 2 and 4 hours postoperatively and during walking at 6 hours postoperatively ( P < 0.05 ) .
RESULTS	Significantly more patients in the intravenous group required supplemental opioid analgesia within the first 4 hours postoperatively ( P < 0.05 ) .
CONCLUSIONS	Intra-articular tenoxicam 20 mg provided better analgesia and decreased the requirements for postoperative analgesic compared with i.v. tenoxicam 20 mg .

###16897237
OBJECTIVE	This study was done to evaluate the effect of landiolol , an ultra-short-acting beta-blocker , on the hemodynamic response and the duration of seizure activity during electroconvulsive therapy ( ECT ) .
METHODS	We designed a prospective , randomized , double-blinded , placebo-controlled , crossover study .
METHODS	Fourteen psychiatric patients participated .
METHODS	Landiolol ( 0.1 mg x kg ( -1 ) or 0.2 mg x kg ( -1 ) ) or saline ( placebo ) was administered IV 1 min before the induction of anesthesia .
METHODS	Unconsciousness was induced with propofol 1.0 mg x kg ( -1 ) IV , and muscle paralysis was produced with succinylcholine 0.6 mg x kg ( -1 ) IV .
METHODS	Subsequently , electrical stimulus was administered to elicit a seizure , and the duration of the motor seizure activity was noted .
RESULTS	The heart rate ( HR ) and rate-pressure product ( RPP ) before ECT were significantly decreased in the 0.2 mg x kg ( -1 ) landiolol group compared with these parameters in the placebo and 0.1 mg x kg ( -1 ) landiolol groups .
RESULTS	Both the 0.1 mg x kg ( -1 ) and 0.2 mg x kg ( -1 ) doses significantly attenuated the degree of tachycardia and RPP after ECT in comparison with the placebo group .
RESULTS	Pretreatment with 0.2 mg x kg ( -1 ) landiolol resulted in a significantly shorter duration of motor seizure than that in the placebo group ( 21 + / - 13 s vs 27 + / - 12 s ) .
CONCLUSIONS	As the landiolol dose of 0.2 mg x kg ( -1 ) caused shorter seizure duration , and because the hemodynamic effects after ECT of the 0.1 mg x kg ( -1 ) and 0.2 mg x kg ( -1 ) doses were similar , it was concluded that a 0.1 mg x kg ( -1 ) landiolol bolus was the appropriate dose pretreatment before ECT .

###21417936
OBJECTIVE	To evaluate the analgesic efficacy of local subcutaneous ( SC ) anesthesia compared with intramuscular ( IM ) opioid sedation during extracorporeal shockwave lithotripsy ( SWL ) in a randomized study .
METHODS	After informed consent was obtained , 125 patients with urolithiasis who were scheduled for SWL were included in the study .
METHODS	The patients in each treatment session were randomized to receive either IM meperidine ( group A ) or SC infiltration of 10mL 2 % lidocaine and 10mL 0.5 % bupivacaine at the area of shockwave entry ( group B ) .
METHODS	Degree of pain was rated by the patient using a five-point visual analogue scale ( VAS ) .
RESULTS	The study included 88 ( 70.4 % ) men and 37 ( 29.6 % ) women with a mean age of 47.612.5 years and a mean body mass index ( BMI ) of 28.164.67 kg/m2 .
RESULTS	Of the patients , 89 , 26 , and 10 received a single , two , or more than two treatment sessions , respectively ( 176 sessions ) .
RESULTS	Maximum stone length was 10.685.12 mm .
RESULTS	Pretreatment stent placement was performed in 17 ( 13.6 % ) patients ( 28 sessions ) .
RESULTS	Group A comprised 89 treatment sessions while 87 were involved in group B. Both groups were similar .
RESULTS	Supplemental intrvenous sedation was needed in two ( 2.5 % ) and four ( 4.6 % ) sessions in groups A and B , respectively .
RESULTS	VAS was not different between both groups ( P = 0.063 ) .
RESULTS	Patients with pretreatment stent placement had significantly lower VAS score compared with patients without stents ( P = 0.012 ) .
RESULTS	Sex and BMI had no impact on the VAS score .
CONCLUSIONS	Local SC anesthesia alone is effective for analgesic purposes during extracorporeal SWL .
CONCLUSIONS	Sex , age , and BMI have no relation to analgesia requirement .

###20232036
OBJECTIVE	To compare the effects of increasing the limit for gastric residual volume ( GRV ) in the adequacy of enteral nutrition .
OBJECTIVE	Frequency of gastrointestinal complications and outcome variables were secondary goals .
METHODS	An open , prospective , randomized study .
METHODS	Twenty-eight intensive care units in Spain .
METHODS	Three hundred twenty-nine intubated and mechanically ventilated adult patients with enteral nutrition ( EN ) .
METHODS	EN was administered by nasogastric tube .
METHODS	A protocol for management of EN-related gastrointestinal complications was used .
METHODS	Patients were randomized to be included in a control ( GRV = 200 ml ) or in study group ( GRV = 500 ml ) .
RESULTS	Diet volume ratio ( diet received/diet prescribed ) , incidence of gastrointestinal complications , ICU-acquired pneumonia , days on mechanical ventilation and ICU length of stay were the study variables .
RESULTS	Gastrointestinal complications were higher in the control group ( 63.6 vs. 47.8 % , P = 0.004 ) , but the only difference was in the frequency of high GRV ( 42.4 vs. 26.8 % , P = 0.003 ) .
RESULTS	The diet volume ratio was higher for the study group only during the 1st week ( 84.48 vs. 88.20 % ) ( P = 0.0002 ) .
RESULTS	Volume ratio was similar for both groups in weeks 3 and 4 .
RESULTS	Duration of mechanical ventilation , ICU length of stay or frequency of pneumonia were similar .
CONCLUSIONS	Diet volume ratio of mechanically ventilated patients treated with enteral nutrition is not affected by increasing the limit in GRV .
CONCLUSIONS	A limit of 500 ml is not associated with adverse effects in gastrointestinal complications or in outcome variables .
CONCLUSIONS	A value of 500 ml can be equally recommended as a normal limit for GRV .

###19542866
BACKGROUND	Abacavir sulfate/lamivudine ( ABC/3TC ) and tenofovir DF/emtricitabine ( TDF/FTC ) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment .
BACKGROUND	This is the first completed , randomized clinical trial to directly compare the efficacy , safety , and tolerability of these agents , each in combination with lopinavir/ritonavir in antiretroviral-naive patients .
METHODS	Six hundred and eighty-eight antiretroviral-naive , HIV-1-infected patients were randomized in this double-blind , placebo-matched , multicenter , noninferiority study to receive a once-daily regimen of either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg , both with lopinavir/ritonavir 800 mg/200 mg .
METHODS	Primary endpoints were the proportion of patients with HIV-1 RNA below 50 copies/ml at week 48 ( missing = failure , switch included analysis ) and the proportion of patients experiencing adverse events over 96 weeks .
RESULTS	At week 48 , 68 % in the ABC/3TC group vs. 67 % in the TDF/FTC group achieved an HIV-1 RNA below 50 copies/ml ( intent-to-treat exposed missing = failure , 95 % confidence interval on the difference -6.63 to 7.40 , P = 0.913 ) , demonstrating the noninferiority of ABC/3TC to TDF/FTC at week 48 .
RESULTS	Noninferiority of the two regimens was sustained at week 96 ( 60 % vs. 58 % , respectively , 95 % confidence interval -5.41 to 9.32 , P = 0.603 ) .
RESULTS	In addition , efficacy of both regimens was similar in patients with baseline HIV-1 RNA > or = 100 000 copies/ml or CD4 cell counts below 50 cells/microl .
RESULTS	Median CD4 recovery ( ABC/3TC vs. TDF/FTC , cells/microl ) was +250 vs. +247 by week 96 .
RESULTS	Premature study discontinuation due to adverse events occurred in 6 % of patients in both groups .
RESULTS	Protocol-defined virologic failure occurred in 14 % of patients in both groups .
CONCLUSIONS	Both ABC/3TC and TDF/FTC provided comparable antiviral efficacy , safety , and tolerability when each was combined with lopinavir/ritonavir in treatment-naive patients .

###25728933
BACKGROUND	Rapid reversal of vitamin K antagonist ( VKA ) - induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures .
BACKGROUND	The optimum means of VKA reversal has not been established in comparative clinical trials .
BACKGROUND	We compared the efficacy and safety of four-factor prothrombin complex concentrate ( 4F-PCC ) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures .
METHODS	In a multicentre , open-label , phase 3b randomised trial we enrolled patients aged 18 years or older needing rapid VKA reversal before an urgent surgical or invasive procedure .
METHODS	We randomly assigned patients in a 1:1 ratio to receive vitamin K concomitant with a single dose of either 4F-PCC ( Beriplex/Kcentra/Confidex ; CSL Behring , Marburg , Germany ) or plasma , with dosing based on international normalised ratio ( INR ) and weight .
METHODS	The primary endpoint was effective haemostasis , and the co-primary endpoint was rapid INR reduction ( 13 at 05 h after infusion end ) .
METHODS	The analyses were intended to evaluate , in a hierarchical fashion , first non-inferiority ( lower limit 95 % CI greater than -10 % for group difference ) for both endpoints , then superiority ( lower limit 95 % CI > 0 % ) if non-inferiority was achieved .
METHODS	Adverse events and serious adverse events were reported to days 10 and 45 , respectively .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT00803101 .
RESULTS	181 patients were randomised ( 4F-PCC n = 90 ; plasma n = 91 ) .
RESULTS	The intention-to-treat efficacy population comprised 168 patients ( 4F-PCC , n = 87 ; plasma , n = 81 ) .
RESULTS	Effective haemostasis was achieved in 78 ( 90 % ) patients in the 4F-PCC group compared with 61 ( 75 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 143 % , 95 % CI 28-258 ) .
RESULTS	Rapid INR reduction was achieved in 48 ( 55 % ) patients in the 4F-PCC group compared with eight ( 10 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 453 % , 95 % CI 319-564 ) .
RESULTS	The safety profile of 4F-PCC was generally similar to that of plasma ; 49 ( 56 % ) patients receiving 4F-PCC had adverse events compared with 53 ( 60 % ) patients receiving plasma .
RESULTS	Adverse events of interest were thromboembolic adverse events ( six [ 7 % ] patients receiving 4F-PCC vs seven [ 8 % ] patients receiving plasma ) , fluid overload or similar cardiac events ( three [ 3 % ] patients vs 11 [ 13 % ] patients ) , and late bleeding events ( three [ 3 % ] patients vs four [ 5 % ] patients ) .
CONCLUSIONS	4F-PCC is non-inferior and superior to plasma for rapid INR reversal and effective haemostasis in patients needing VKA reversal for urgent surgical or invasive procedures .
BACKGROUND	CSL Behring .

###21224436
BACKGROUND	Patients treated with hemodialysis ( HD ) have been reported to have decreased levels of -3 polyunsaturated fatty acids ( PUFAs ) in plasma and cells .
BACKGROUND	The aim of this study was to investigate the effect of -3 PUFAs administered intravenously during HD , as well as the effect of HD treatment , on the fatty acid composition of plasma free fatty acids ( FFAs ) , plasma phospholipids , and platelet phospholipids .
METHODS	Forty-four HD patients were randomized to groups receiving either a single dose of a lipid emulsion containing 4.1 g of -3 PUFAs or placebo ( saline ) administered intravenously during HD .
METHODS	Blood was drawn immediately before ( baseline ) and after ( 4 hours ) HD and before the next HD session ( 48 hours ) .
METHODS	Fatty acid composition was measured using gas chromatography .
RESULTS	The increase in -3 FFAs was greater in the -3 PUFA group compared with the placebo group , whereas the increase in total FFAs was similar between the 2 groups .
RESULTS	In the -3 PUFA group , -3 PUFAs in plasma phospholipids were higher after 48 hours than at baseline , and in platelet phospholipids , -3 PUFAs increased after 4 hours .
RESULTS	In the placebo group , no changes were observed in -3 PUFAs in plasma and platelet phospholipids .
CONCLUSIONS	Intravenous -3 PUFAs administered during HD caused a transient selective increase in -3 FFA concentration .
CONCLUSIONS	Furthermore , -3 PUFAs were rapidly incorporated into platelets , and the content of -3 PUFAs in plasma phospholipids increased after 48 hours .

###23413781
OBJECTIVE	Contrast-induced nephropathy ( CIN ) is a relatively common and serious complication , which occurs after the administration of contrast materials to patients .
OBJECTIVE	Although the pathophysiology of CIN is not exactly understood , ischemia of the medulla , oxidative stress , and direct toxicity of the contrast material are some of the factors that are implicated for the pathogenesis of CIN .
OBJECTIVE	To date , the only therapy that reduces the risk of CIN is volume expansion .
OBJECTIVE	There are conflicting results about the roles of angiotensin receptor blockers ( ARB ) and calcium channel blockers ( CCB ) in studies on CIN .
OBJECTIVE	For this reason the aim of this study was to compare the efficiency of the prophylactic use of amlodipine/valsartan plus hydration versus hydration only for the prevention of CIN in patients undergoing coronary angiography ( CAG ) .
METHODS	We prospectively enrolled 90 patients whose baseline serum creatinine levels were under 2.1 mg/dL and who were scheduled for CAG .
METHODS	Patients were divided into two groups .
METHODS	Group I ( n = 45 ) , consisted of patients who received amlodipine/valsartan plus hydration , group II ( n = 45 ) consisted of patients who received only hydration .
METHODS	The patients in group I were given amlodipine/valsartan 5/160 mg once a day for a total of 3 days , starting one day before CAG and continuing on the day of and the day after the procedure .
METHODS	A 1 mL/kg/h sodium chloride infusion was administered for a total of 24 h , starting 12 h before the procedure and 12 h after , in all patients .
METHODS	The baseline serum creatinine ( Scre ) level was obtained before the procedure and repeated 48 h after .
METHODS	CIN was defined as an increase of 0.5 mg/dL or an increase of > 25 % in baseline Scre on the second day after CAG .
RESULTS	The baseline clinical characteristics of the treatment groups were similar .
RESULTS	Baseline Scre was 1.13 0.33 in group I and 1.07 0.23 mg/dL in group II ( p = 0.31 ) .
RESULTS	There was a significant difference between the Scre levels 48 h after CAG between the two groups ( 1.18 0.33-1 .05 0.23 ) ( p = 0.03 ) .
RESULTS	The reason for this was the increase of Scre in group I. CIN occurred in 17.8 % ( 8/45 ) of patients in group I and in 6.7 % ( 3/45 ) of patients in group II ( p = 0.197 ) .
RESULTS	In the diabetic subgroup , CIN occurred in 10.5 % ( 2/19 ) of patients taking amlodipine/valsartan and in none of the patients in group II ( p = 0.486 ) .
RESULTS	The Mehran scores of the patients who developed CIN were significantly higher than those patients who did not develop CIN .
CONCLUSIONS	Amlodipine/valsartan therapy plus hydration did not reduce the risk of CIN in chronic kidney disease ( CKD ) Stage 2 patients who underwent elective CAG using a low-osmolar nonionic contrast medium .
CONCLUSIONS	This is because there was a decrease in the glomerular filtration rate ( GFR ) using the Levey Modification of Diet in Renal Disease ( MDRD ) formula in the amlodipine/valsartan group and CIN occurred at a higher frequency in this group ; ARBs and CCBs may be withheld before CAG in high-risk patients .

###21983191
BACKGROUND	A critical component of evaluating the outcomes after surgery to restore lost elbow motion is the range of motion ( ROM ) of the elbow .
BACKGROUND	This study examined if digital photography-based goniometry is as accurate and reliable as clinical goniometry for measuring elbow ROM .
METHODS	Instrument validity and reliability for photography-based goniometry were evaluated for a consecutive series of 50 elbow contractures by 4 observers with different levels of elbow experience .
METHODS	Goniometric ROM measurements were taken with the elbows in full extension and full flexion directly in the clinic ( once ) and from digital photographs ( twice in a blinded random manner ) .
RESULTS	Instrument validity for photography-based goniometry was extremely high ( intraclass correlation coefficient : extension = 0.98 , flexion = 0.96 ) .
RESULTS	For extension and flexion measurements by the expert surgeon , systematic error was negligible ( 0 and 1 , respectively ) .
RESULTS	Limits of agreement were 7 ( 95 % confidence interval [ CI ] , 5 to 9 ) and -7 ( 95 % CI , -5 to -9 ) for extension and 8 ( 95 % CI , 6 to 10 ) and -7 ( 95 % CI , -5 to -9 ) for flexion .
RESULTS	Interobserver reliability for photography-based goniometry was better than that for clinical goniometry .
RESULTS	The least experienced observer 's photographic goniometry measurements were closer to the reference measurements than the clinical goniometry measurements .
CONCLUSIONS	Photography-based goniometry is accurate and reliable for measuring elbow ROM .
CONCLUSIONS	The photography-based method relied less on observer expertise than clinical goniometry .
CONCLUSIONS	This validates an objective measure of patient outcome without requiring doctor-patient contact at a tertiary care center , where most contracture surgeries are done .

###23784615
OBJECTIVE	The HEBE III trial showed that epoetin alfa administration in patients with a first ST-elevation myocardial infarction ( STEMI ) did not improve left ventricular function at 6 weeks after primary percutaneous coronary intervention ( PCI ) .
OBJECTIVE	The long term effects of erythropoiesis - stimulating agents on cardiovascular morbidity and mortality are unknown , therefore we evaluated clinical events at 1 year after PCI .
METHODS	A total of 529 patients with a first STEMI and successful primary PCI were randomized to standard optimal medical treatment ( N = 266 ) or an additional bolus of 60,000 IU epoetin alfa administered intravenously ( N = 263 ) within 3 h after PCI .
METHODS	Analyses were performed by intention to treat .
RESULTS	At 1 year after STEMI , 485 patients had complete follow-up .
RESULTS	The rate of the composite end point of all-cause mortality , re-infarction , target vessel revascularization , stroke and/or heart failure was 6.4 % ( N = 15 ) in the epoetin alfa group and 9.6 % ( N = 24 ) in the control group ( p = 0.18 ) .
RESULTS	Thromboembolic events were present in 1.3 % ( N = 3 ) of patients in the epoetin alfa group and 2.4 % ( N = 6 ) in the control group .
RESULTS	There was no evidence of benefit from epoetin alfa administration in subgroups of patients .
CONCLUSIONS	Administration of a single bolus of epoetin alfa in patients with STEMI does not result in a reduction of cardiovascular events at 1 year after primary PCI .
CONCLUSIONS	There was a comparable incidence of thromboembolic complications in both treatment groups , suggesting that epoetin alfa administration is safe at long term .

###9562581
BACKGROUND	Recombinant human interleukin-2 ( aldesleukin ) and recombinant human interferon alfa can induce notable tumor regression in a limited number of patients with metastatic renal-cell carcinoma .
BACKGROUND	We conducted a multicenter , randomized trial to determine the effect of each cytokine independently and in combination , and to identify patients who are best suited for this treatment .
METHODS	Four hundred twenty-five patients with metastatic renal-cell carcinoma were randomly assigned to receive either a continuous intravenous infusion of interleukin-2 , subcutaneous injections of interferon alfa-2a , or both .
METHODS	The main outcome measure was the response rate ; secondary outcomes were the rates of event-free and overall survival .
METHODS	Predictive factors for response and rapid progression were identified by multivariate analysis .
RESULTS	Response rates were 6.5 percent , 7.5 percent , and 18.6 percent ( P < 0.01 ) for the groups receiving interleukin-2 , interferon alfa-2a , and interleukin-2 plus interferon alfa-2a , respectively .
RESULTS	At one year , the event-free survival rates were 15 percent , 12 percent , and 20 percent , respectively ( P = 0.01 ) .
RESULTS	There was no significant difference in overall survival among the three groups .
RESULTS	Toxic effects of therapy were more common in patients receiving interleukin-2 than in those receiving interferon alfa-2a .
RESULTS	Response to treatment was associated with having metastasis to a single organ and with receiving the combined treatment .
RESULTS	The probability of rapid progression of disease was at least 70 percent for patients with at least two metastatic sites , liver metastases , and a period of less than one year between the diagnosis of the primary tumor and the appearance of metastases .
CONCLUSIONS	Cytokines are active in a few patients with metastatic renal-cell carcinoma .
CONCLUSIONS	The higher response rate and longer event-free survival obtained with a combination of cytokines must be balanced against the toxicity of such treatment .

###15770007
BACKGROUND	The benefit of screening for prostate cancer using prostate-specific antigen ( PSA ) testing and digital rectal examination ( DRE ) is uncertain and is under evaluation in a randomized prospective trial , the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial .
BACKGROUND	Although the final results are several years away , the initial round of screening is complete .
BACKGROUND	We describe the population enrolled in the PLCO trial , their baseline PSA and DRE screening results , and diagnostic follow-up results during the first year of follow-up .
METHODS	A total of 38,350 men were randomly assigned to the screening arm of the PLCO trial from November 1993 through June 2001 .
METHODS	Men were advised to seek diagnostic follow-up from their primary care provider if their DRE was suspicious for cancer and/or if their serum PSA level was higher than 4 ng/mL .
METHODS	PLCO trial staff obtained records related to diagnostic follow-up .
RESULTS	Compliance with both screening tests was high ( more than 89 % ) .
RESULTS	At screening , 7.5 % of men had a positive DRE ( i.e. , suspicious for cancer ) and 7.9 % had a PSA level higher than 4 ng/mL .
RESULTS	Of the men with positive screening tests , 74.2 % underwent additional diagnostic testing , and 31.5 % underwent a prostatic biopsy within 1 year .
RESULTS	Overall , 1.4 % of the men in the screening arm were diagnosed with prostate cancer , the majority of whom had clinically localized cancer .
RESULTS	These compliance , biopsy , and cancer detection rates appear to be representative of contemporary practice patterns .
CONCLUSIONS	The PLCO trial is evaluating PSA - and DRE-based screening for prostate cancer in a clinically valid manner .
CONCLUSIONS	Whether such screening will result in a reduction of prostate cancer mortality can not be answered until the randomized comparison is completed .

###25372452
BACKGROUND	Surgical site infection ( SSI ) is the second most common type of nosocomial infections in the United States .
BACKGROUND	In Uruguay , the incidence after prostatectomies is 2.6 % .
BACKGROUND	The aim of our study was to compare the efficacy of two skin antiseptics and to determine possible risk factors for SSI in patients undergoing surgery for benign prostatic hyperplasia ( BPH ) .
METHODS	A randomized trial included 70 patients operated on for BPH , of whom 56 ( 80 % ) underwent open surgery .
METHODS	Patients were treated by the same surgical team in a tertiary general hospital that is a referral center for patients with urologic diseases .
METHODS	Skin antisepsis was performed randomly using either 0.5 % povidone-iodine or chlorhexidine in an alcohol base ( Chemisol ( ) ) .
METHODS	Possible risk factors investigated were age , renal dysfunction , bladder stones , preoperative urinary catheter , positive preoperative urine culture , operative time and technique , and vesicocutaneous fistula .
RESULTS	Of all patients , 41 ( 59 % ) had a urinary catheter preoperatively .
RESULTS	Urine cultures were positive in 31 patients , of whom 29 ( 94 % ) had a urinary catheter .
RESULTS	Surgical site infection occurred in 10 patients ( 18 % ) , and 100 % of the causative microorganisms were gram-negative bacteria characteristic of the urinary flora .
RESULTS	The type of antiseptic did not affect the risk of SSI ( p = 1.00 ) .
RESULTS	The most important risk factor for infection was the presence of a urinary catheter preoperatively ( p = 0.003 ) ; also significant were the formation of a vesicocutaneous fistula ( p = 0.008 ) , increasing age ( p = 0.02 ) , and the presence of a positive preoperative urine culture ( p = 0.03 ) .
CONCLUSIONS	In a cohort of patients submitted to open prostatectomy , SSI was not related to the type of antiseptic .
CONCLUSIONS	The main risk factor was the presence of a urinary catheter preoperatively .
CONCLUSIONS	All microorganisms isolated from the SSIs were characteristic of urinary tract infections .

###12911119
BACKGROUND	Extrafine aerosols may improve asthma symptom control through increased lung deposition of medication to inflamed peripheral airways .
METHODS	The effect of switching patients with asthma maintained on up to 2000 microg/day chlorofluorocarbon-beclomethasone dipropionate ( CFC-BDP ) , 1600 microg/day budesonide , 1000 microg/day fluticasone , or 2000 microg/day flunisolide , to a reduced dose of hydrofluoroalkane-134a BDP ( HFA-BDP ) extrafine aerosol ( maximum 800 microg/day ) was investigated during an open-label multicentre study .
METHODS	Following a 7-14-day run-in on previous medication , 716 patients were randomised to 24 weeks ' treatment with an appropriate reduced dose of HFA-BDP .
RESULTS	Morning peak expiratory flow ( AM PEF ) measurements showed that , after 24 weeks , the reduced dose of HFA-BDP maintained equivalent lung function compared with all previous medications .
RESULTS	Furthermore , asthma symptom scores revealed improvements across all groups and the proportion of symptom free days and nights and beta-agonist free days increased significantly ( p < 0.05 ) in all but one group .
RESULTS	Quality of life improved with 80 % of patients reporting goo/very good overall asthma control compared with 70 % previously .
RESULTS	Treatment-associated adverse events were generally infrequent , mild and transient .
CONCLUSIONS	Patients on conventional inhaled corticosteroids may reduce their daily steroid dose to 800 microg or less whilst maintaining lung function and improving asthma symptom control by using the extrafine aerosol of HFA-BDP .

###22494068
OBJECTIVE	The ideal instrument for initial periodontal therapy should enable the removal of all extraneous substances from the root surfaces without any iatrogenic effects .
OBJECTIVE	Because of that the objective of this study is to analyse and to compare the root surface roughness after using Gracey curettes , termination diamond burs ( 40 m ) , a piezo-ceramic ultrasonic scaler and a piezosurgery ultrasonic scaler using confocal microscopy and scanning electron microscopy .
METHODS	A 2 mm 2 mm interproximal root area of 20 teeth ( n = 40 surfaces ) was evaluated by confocal microscopy ( 20 magnification ) and scanning electron microscopy ( 50 to 1000 magnification ) .
METHODS	Teeth were randomly assigned to the following four groups : Gracey curettes with 15 vertical strokes ; termination diamond burs ( 40 m ) at 3000 r.p.m. ; a piezo-ceramic ultrasonic scaler with a power of 11 ; and a piezosurgery ultrasonic scaler in mode ROOT with a power of two .
RESULTS	Confocal microscopy revealed that curettes [ mean changes in the value of surface roughness average reduced by 0.11 0.3 ] , piezo-ceramic ultrasonic scaler ( roughness average reduced by 0.47 0.93 ) and piezosurgery ultrasonic scaler ( roughness average reduced by 0.62 0.93 ) left a smoother surface than termination diamond burs ( roughness average increased by 0.39 0.18 ) .
RESULTS	Statistically significant differences were observed in roughness ( p = 0.005 ) between piezosurgery and termination diamond burs ( p = 0.005 ) .
RESULTS	No statistically significant differences were between piezosurgery and Gracey curettes ( p = 0.140 ) and between piezosurgery and piezo-ceramic ultrasonic scalers ( p = 0.745 ) .
RESULTS	Confocal microscopy and scanning electron microscopy showed that piezosurgery seems to leave the smoothest surface .
RESULTS	Surfaces treated with termination burs appear to show more scratches and pits .
CONCLUSIONS	Three of the four instruments tested for root planing reduced surface roughness ; however , the piezosurgery ultrasonic scaler produced the smoothest surface .
CONCLUSIONS	The termination diamond burs ( 40 m ) produced a rougher surface than the ultrasonic instruments and the hand curettes .
CONCLUSIONS	Further clinical studies are needed .

###21208101
BACKGROUND	Triple-negative breast cancers have inherent defects in DNA repair , making this cancer a rational target for therapy based on poly ( adenosine diphosphate-ribose ) polymerase ( PARP ) inhibition .
METHODS	We conducted an open-label , phase 2 study to compare the efficacy and safety of gemcitabine and carboplatin with or without iniparib , a small molecule with PARP-inhibitory activity , in patients with metastatic triple-negative breast cancer .
METHODS	A total of 123 patients were randomly assigned to receive gemcitabine ( 1000 mg per square meter of body-surface area ) and carboplatin ( at a dose equivalent to an area under the concentration-time curve of 2 ) on days 1 and 8 -- with or without iniparib ( at a dose of 5.6 mg per kilogram of body weight ) on days 1 , 4 , 8 , and 11 -- every 21 days .
METHODS	Primary end points were the rate of clinical benefit ( i.e. , the rate of objective response [ complete or partial response ] plus the rate of stable disease for 6 months ) and safety .
METHODS	Additional end points included the rate of objective response , progression-free survival , and overall survival .
RESULTS	The addition of iniparib to gemcitabine and carboplatin improved the rate of clinical benefit from 34 % to 56 % ( P = 0.01 ) and the rate of overall response from 32 % to 52 % ( P = 0.02 ) .
RESULTS	The addition of iniparib also prolonged the median progression-free survival from 3.6 months to 5.9 months ( hazard ratio for progression , 0.59 ; P = 0.01 ) and the median overall survival from 7.7 months to 12.3 months ( hazard ratio for death , 0.57 ; P = 0.01 ) .
RESULTS	The most frequent grade 3 or 4 adverse events in either treatment group included neutropenia , thrombocytopenia , anemia , fatigue or asthenia , leukopenia , and increased alanine aminotransferase level .
RESULTS	No significant difference was seen between the two groups in the rate of adverse events .
CONCLUSIONS	The addition of iniparib to chemotherapy improved the clinical benefit and survival of patients with metastatic triple-negative breast cancer without significantly increased toxic effects .
CONCLUSIONS	On the basis of these results , a phase 3 trial adequately powered to evaluate overall survival and progression-free survival is being conducted .
CONCLUSIONS	( Funded by BiPar Sciences [ now owned by Sanofi-Aventis ] ; ClinicalTrials.gov number , NCT00540358 . )

###20124925
BACKGROUND	Point-pair registration is widely used in an image-guided neurosurgery system .
BACKGROUND	Poor distribution of the fiducial points leads to an increase in the target registration error ( TRE ) .
OBJECTIVE	This study aimed to provide templates consisting of optimized positioning of the fiducial points to reduce the TRE in image-guided neurosurgery .
METHODS	We divided the head into 6 regions and provided distribution templates of the fiducial points for each of them .
METHODS	A variable termed TREM ( r ) was used to express the approximate expected square of the TRE at the target point with a specified distribution of fiducial points .
METHODS	We randomly selected 85 patients from 5 hospitals who underwent image-guided neurosurgery and compared the TREM ( r ) of the real fiducial points with that of the templates .
RESULTS	We grouped the patients by hospitals and regions .
RESULTS	The mean TREM ( r ) s of the templates were much smaller than those of the real fiducial points .
RESULTS	In each group , the range of the TREM ( r ) values of the templates was much smaller than that of the real fiducial points .
CONCLUSIONS	This study provides an easy method to implement a good distribution of the fiducial points to help reduce TRE in image-guided neurosurgery .
CONCLUSIONS	The templates are simple and exact and can be easily integrated into current workflow .

###22123869
OBJECTIVE	To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization .
METHODS	We conducted a prospective , randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at 2 months of age .
METHODS	Mothers of infants in the control group received standard care instructions from their infants ' health care provider , and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter , for a total of 5 doses .
METHODS	Infant age and birth weight and immunization factors , such as acetaminophen use and timing of administration , were evaluated for changes in infant sleep times after immunization .
RESULTS	Sleep duration in the first 24 hours after immunization was increased , particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines .
RESULTS	Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not .
RESULTS	However , acetaminophen use was not a significant predictor of sleep duration when other factors were controlled .
CONCLUSIONS	If further research confirms the relationship between time of day of vaccine administration , increased sleep duration after immunization , and antibody responses , then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization , regardless of acetaminophen administration .

###21070344
OBJECTIVE	Two packages of adaptive computer-assisted instruction ( CAIs ) , both offering questions and subsequent feedback , were compared in terms of amount of feedback offered , learning efficiency and appreciation .
OBJECTIVE	Feedback was either barely more than knowledge of result ( ` minimal ' ) or consisted of a complete additional learning path ( ` elaborate ' ) .
OBJECTIVE	The CAIs differed in the way the type of feedback given was triggered .
METHODS	A total of 97 Bachelor of Science students were stratified based on a pre-test before the experiment and were allocated randomly to two groups to receive either a ` programme-assessed ' or a ` student-assessed ' treatment .
METHODS	In the former , the feedback provided by the CAI ( either elaborate or minimal ) was completely determined by the objective correctness of the student 's response .
METHODS	In the student-assessed treatment , elaborate feedback was provided only to students who stated explicitly that they did not know the answer .
METHODS	Afterwards , students completed a post-test and an appreciation questionnaire .
RESULTS	Both CAIs resulted in a significant learning effect , but overall the effect was significantly higher in the programme-assessed treatment .
RESULTS	Students using the student-assessed CAI hardly ever used the ' I do n't know ' option and therefore received mostly minimal feedback .
RESULTS	There was no difference in students ' appreciation between treatments .
RESULTS	An interaction between the learner 's prior knowledge and treatment was found : for learners with a high level of prior knowledge the programme-assessed treatment resulted in significantly higher learning effectiveness compared with the student-assessed treatment , whereas for learners with a low level of prior knowledge there was no significant difference .
CONCLUSIONS	Our results demonstrate that learners achieved a significantly higher learning effectiveness in the programme-assessed treatment in which the received feedback was fully controlled by the correctness of the answer , compared with the student-assessed treatment .
CONCLUSIONS	In the latter , students hardly ever admitted to not knowing the answer .
CONCLUSIONS	Therefore , student-initiated use of the tool in a student-assessed CAI requires to be improved .

###16496249
OBJECTIVE	To compare the intraocular pressure ( IOP ) lowering effect and safety of latanoprost , travoprost given every evening , and the fixed combination dorzolamide + timolol ( DTFC ) given twice daily in pseudoexfoliation glaucoma ( PXG ) .
METHODS	This randomized , prospective , investigator-masked study has been conducted with 50 PXG patients .
METHODS	Patients were assigned to one of three groups : travoprost 0.004 % , fixed combination of dorzolamide 2 % + timolol 0.5 % , or latanoprost 0.005 % for 6 months .
METHODS	At baseline and 0.5 , 1 , 2 , 3 , 4 , 5 , and 6 months of therapy , IOP ( 8 am , 10 am , 4 pm ) , blood pressures , and pulse rates were measured , and ophthalmologic examination was performed .
METHODS	The side effects were recorded at each visit .
RESULTS	Forty-two of the 50 patients initially enrolled completed this study .
RESULTS	Withdrawn patients included one ( latanoprost ) for lack of efficacy , five ( three travoprost , one latanoprost , one DTFC ) for adverse events , and two ( one latanoprost , one DTFC ) for loss of follow-up .
RESULTS	Each of the three drugs considerably reduced the IOP in PXG cases throughout the 6 months .
RESULTS	Mean IOP reduction at 6 months was -9.3 + / -2.9 mmHg in the travoprost group , -8.2 + / -1.2 mmHg in the latanoprost group , and 11.5 + / -3.3 mmHg in the DTFC group .
RESULTS	Comparing the groups , DTFC is more effective than latanoprost and travoprost in lowering IOP ( p < 0.05 ) .
RESULTS	There was no difference between travoprost and latanoprost .
RESULTS	The most common treatment-related adverse event was conjunctival hyperemia .
RESULTS	Intensity of ocular hyperemia was greater in the travoprost group compared with the latanoprost and DTFC groups ( p < 0.05 ) .
RESULTS	There were no significant effects on systemic safety parameters .
CONCLUSIONS	The results demonstrated that DTFC is more effective in reducing IOP than latanoprost and travoprost .
CONCLUSIONS	Latanoprost and travoprost had similar ocular hypotensive effects in patients with PXG .
CONCLUSIONS	All three drugs were well tolerated ; there were fewer ocular side effects attributable in the latanoprost group .

###22262230
BACKGROUND	An experimental study showed that nebivolol is an effective agent in contrast-induced nephropathy ( CIN ) prophylaxis .
OBJECTIVE	We hypothesized that prophylactic nebivolol use had protective effects on renal function in human beings subjected to iodinated contrast agent since it has vasodilatory effect and antioxidant properties .
METHODS	The present study enrolled 120 patients scheduled for coronary angiography and ventriculography .
METHODS	All patients were hydrated with intravenous isotonic saline .
METHODS	The patients in group I received 600 mg N-acetylcysteine every 12 hours for 4 days .
METHODS	The patients in group II received 5 mg nebivolol every 24 hours for 4 days .
METHODS	The patients in group III were only hydrated .
METHODS	The primary endpoint was the occurrence of CIN .
METHODS	The secondary endpoint was the change in serum creatinine ( Cr ) levels at 2 days and 5 days after the contrast exposure .
RESULTS	Nine ( 22.5 % ) patients in group I developed CIN , as did 8 patients ( 20.0 % ) in group II and 11 patients ( 27.5 % ) in group III ( P = 0.72 ) .
RESULTS	Changes in mean Cr level from baseline to day 2 were not statistically significant in all groups .
RESULTS	However , we detected a statistically significant increase in mean Cr levels at day 5 compared with baseline levels in group I and group III ( from 1.42 0.13 to 1.52 0.26 , p2 = 0.02 ; and from 1.43 0.14 to 1.55 0.30 , p2 = 0.01 , respectively ) .
RESULTS	Although an increase was detected in mean Cr level from baseline to the 5-day Cr level in group II , this did not reach statistical significance ( from 1.40 0.12 to 1.48 0.23 , P = 0.06 ) .
CONCLUSIONS	Pretreatment with nebivolol is protective against nephrotoxic effects of contrast media .

###16996462
OBJECTIVE	This study was undertaken to assess the impact of interactive , computer-based versus conventional , paper-based format in student , resident , and fellow learning and retention of anatomy knowledge .
METHODS	Randomized longitudinal cohort design with scores repeated as pre - , post - , and follow-up tests .
METHODS	Subjects were randomly assigned to an anatomy module in computer-based ( CD-ROM ) format and 1 in paper-based format .
METHODS	A follow-up examination was administered 3 weeks after the posttest to evaluate retention of knowledge .
METHODS	Tests results were analyzed by using Student t tests and analysis of variance .
RESULTS	Thirty-nine subjects completed all testing .
RESULTS	Regardless of instructional method , pretest to posttest scores improved ( P < .01 ) , and posttest to follow-up test scores decreased among all levels of training ( P < .01 ) .
RESULTS	Student satisfaction was highest with CD-ROM format .
CONCLUSIONS	Improvement and retention of anatomy knowledge was not significantly different when comparing a new CD-ROM interactive approach with a traditional paper-based method .

###15855263
BACKGROUND	Neuromuscular symptoms and impaired muscle energy metabolism have been described in subclinical hypothyroidism ( sHT ) .
OBJECTIVE	The aim of the study was to evaluate the energy and substrate response to exercise in sHT patients using a standardized protocol and to test the effect of L-T ( 4 ) replacement in a double-blind , randomized , placebo-controlled fashion .
METHODS	We studied 23 sHT patients and 10 matched euthyroid controls .
METHODS	Oxygen uptake ( VO ( 2 ) ) , carbon dioxide output , and heart rate were measured during incremental step-up exercise .
METHODS	Blood glucose , lactate , pyruvate , free fatty acid , glycerol , and beta-hydroxybutyrate concentrations were measured at rest , every 2 min during exercise , and during 20 min of recovery .
METHODS	The exercise protocol was repeated after 6 months of placebo or L-T ( 4 ) - restored euthyroidism .
RESULTS	Maximal power output ( P = 0.02 ) and VO ( 2 ) max ( P = 0.04 ) were reduced in sHT , and , with increasing workload , patients achieved higher heart rates ( P < 0.03 ) at VO ( 2 ) values equivalent to those of controls .
RESULTS	The respiratory quotient increments were significantly higher in patients than controls ( P < 0.04 ) .
RESULTS	Blood lactate and pyruvate and their ratio rose with a steeper slope ( P < 0.0001 , P < 0.001 , and P < 0.01 , respectively ) in patients than controls .
RESULTS	Resting plasma free fatty acid and blood glycerol levels were significantly higher in patients than controls ( P < 0.0003 and P < 0.003 , respectively ) throughout baseline , exercise , and recovery .
RESULTS	L-T ( 4 ) replacement , while improving neuromuscular symptoms , did not produce significant changes in the energy or substrate response to exercise .
CONCLUSIONS	The response to exercise is altered both in terms of tolerance and pattern of substrate utilization in sHT patients .
CONCLUSIONS	Restoring stable euthyroidism does not correct this defect over a 1-yr period .

###1334248
OBJECTIVE	to assess the hypocholesterolaemic effect of adding 50 g of oatbran to the diet of hypercholesterolaemic subjects already prescribed a diet with less than 30 % of energy from fat .
METHODS	twenty-nine volunteers aged 21-67 years with total serum cholesterol levels 5.59-8 .5 mmol/L prescribed a diet containing less than 30 % of energy intake as fat , and with a body mass index between 19.8 and 29.3 , were enrolled in a crossover study to assess the effect of the addition to the diet of 50 g daily of oatbran .
METHODS	After six weeks of an oat-free control diet , subjects were randomised to eat 50 g daily of oatbran or to continue on the oat-free diet .
METHODS	Six weeks later the subjects crossed to the alternative diet for a further six week period .
METHODS	Lipid levels were assessed in weeks five and six of each study period .
RESULTS	twenty-four subjects completed the study consuming 51.7 ( SD 15.5 ) g of oatbran daily during the treatment phase .
RESULTS	No significant difference was seen between the oatbran and control diet periods in body mass index , energy or fat intake , or in total cholesterol , LDL and HDL fractions , apolipoprotein A1 and B levels , or triglyceride levels .
RESULTS	Considerable variation was observed between the paired lipid results .
CONCLUSIONS	ingestion of 50 g of oatbran daily by hypercholesterolaemic subjects on a low fat diet showed no influence on serum lipid levels .
CONCLUSIONS	The importance of using at least duplicate samples in assessing changes in lipid values is emphasised .

###9191659
BACKGROUND	`` Immune-enhancing '' diets ( IEDs ) are aimed at improving outcomes in patients suffering trauma and infection .
BACKGROUND	This study was conducted to evaluate a popular IED in patients suffering burn injury .
METHODS	Fifty burned patients were randomized to receive either Impact ( Sandoz Nutrition , Minneapolis , Minn ) , an IED enhanced with omega-3 fatty acids , arginine , and RNA , or Replete ( Clintec , Deerfield , Ill ) , our standard high-protein diet .
METHODS	Feedings were begun within 48 hours of injury , and continued until patients supported themselves with oral intake .
RESULTS	Forty-nine patients completed the study .
RESULTS	The two feeding groups did not differ with respect to age , burn size , incidence of inhalation injury , or the quantity of calories and protein received .
RESULTS	There were no differences between groups in mortality , length of hospitalization , hospital charges , days of ventilator support , or incidence of complications .
RESULTS	Patients with inhalation injuries required more ventilatory support , and had longer lengths of hospitalization and higher costs .
CONCLUSIONS	Administration of an IED has no clear advantages over the use of less expensive high-protein enteral nutrition in burn patients .

###7600396
OBJECTIVE	Mental nerve block is frequently used to aid repair of facial lacerations ; both percutaneous and intraoral approaches to blocking this nerve are used , but have never been compared .
OBJECTIVE	The authors compared the two techniques for pain of administration and effectiveness of anesthesia .
METHODS	A prospective , randomized , single-blind , crossover study was conducted using ten healthy volunteers aged 22 to 33 years .
METHODS	Patients having prior experience with mental nerve blocks , lidocaine allergy , active oral/facial infection , or previous facial fractures were excluded .
METHODS	Bilateral mental nerve blocks were done using intraoral technique on one side and percutaneous technique on the other .
METHODS	Both techniques were used by the same investigator and were carried out with 27-gauge needles and 2.5 mL of 2 % buffered lidocaine at room temperature injected over 20 seconds .
METHODS	The oral mucosa was topically anesthetized with viscous lidocaine for 1 minute prior to intraoral injection .
METHODS	The orders of the blocks and sides of the face anesthetized were randomized .
METHODS	Subjective and objective pain ( visual-analog scale ) , efficacy ( anesthesia of lower lip ) , time to onset , and duration of anesthesia were evaluated .
RESULTS	The intraoral technique was subjectively less painful than the percutaneous approach in nine of ten subjects ( p = 0.02 ) .
RESULTS	Scores on the visual-analog pain scale were significantly lower for the intraoral technique ( p = 0.03 ) .
RESULTS	Intraoral injection produced lower-lip anesthesia in 10/10 subjects versus 7/10 for percutaneous ( p = 0.25 ) .
RESULTS	Times to onset ( approximately 1-2 minutes ) and durations of anesthesia ( approximately one hour ) were similar for the two techniques .
CONCLUSIONS	The intraoral approach to the mental nerve block with adjunctive topical anesthesia was subjectively and objectively less painful than the percutaneous approach without adjunctive anesthesia .
CONCLUSIONS	While the intraoral approach had a greater efficacy of lower-lip anesthesia and a longer duration of action , these differences were not statistically significant .

###8849352
OBJECTIVE	To assess the relative efficacy of methotrexate ( MTX ) , azathioprine ( AZA ) , and their combination in the treatment of rheumatoid arthritis ( RA ) in a double-blind , prospective , multicenter , controlled trial .
METHODS	Two hundred nine patients with active RA were treated with escalating doses of MTX ( 5-15 mg/week ) , AZA ( 50-150 mg/day ) , or combination ( 5mg MTX/week plus 50 mg AZA/day -7.5 mg MTX/week plus 100 mg AZA/day ) , with opportunity to increase the dosage at 6-week intervals .
METHODS	The patients were evaluated for significant clinical and laboratory improvement and assessed for radiologic progression at 48 weeks .
RESULTS	One hundred ten patients remained on the initial , randomly assigned therapeutic regimen .
RESULTS	The percentage of patients who were responders , defined as those who had 30 % or greater improvement in at least 3 of 4 variables , was 38 % for the combination treatment , 26 % for AZA , and 45 % for MTX ( P = 0.06 ) .
RESULTS	A trend toward decreased radiologic progression was seen in the MTX-treated patients .
RESULTS	Termination of treatment due to adverse experience occurred more frequently with combination and AZA treatments than with MTX treatment .
RESULTS	Lack of effectiveness , adverse gastrointestinal effects , and liver enzyme elevation were the most frequent causes of treatment discontinuation .
CONCLUSIONS	This study establishes that the combination of MTX and AZA in the dosages utilized is not associated with more toxicity than treatment with single agents ; however , enhanced efficacy is also not seen .
CONCLUSIONS	There is a trend toward decreased radiologic progression in patients treated with MTX .

###8365298
BACKGROUND	Comparative studies of albuterol by wet nebulizer or metered dose inhaler have tested fixed doses of medications .
BACKGROUND	We compared the dose-response relationship to albuterol by wet nebulization or metered dose inhaler in acute asthma .
METHODS	Randomized , double-blind , placebo-controlled trial .
METHODS	Patients with acute asthma received either albuterol , 0.4 mg , by metered dose inhaler ( and holding chamber ) or albuterol , 2.5 mg , by wet nebulizer every 30 min until maximal bronchodilation .
METHODS	Forty patients ( forced expiratory volume in 1 s [ FEV1 ] : 1.15 + / - 0.43 L ; 36 + / - 12 percent predicted ) received metered dose inhaler and 40 others ( FEV1 : 1.08 + / - 0.52 L ; 35 + / - 16 percent predicted ) received wet nebulization .
RESULTS	Twenty-six patients ( 65 percent ) receiving metered dose inhaler and 30 ( 75 percent ) receiving wet nebulization achieved maximal bronchodilation after two doses .
RESULTS	Almost all reached maximal bronchodilation by four doses .
RESULTS	The FEV1 improved by 0.72 + / - 0.49 L for metered dose inhaler and 0.68 + / - 0.61 L for wet nebulizer ( p = 0.71 ) .
RESULTS	A significant linear relationship was seen in both groups ( metered dose inhaler r = 0.94 ; wet nebulizer r = 0.98 ) between the log dose of albuterol and change in FEV1 .
RESULTS	About 1/6 the wet nebulizer dose of albuterol was needed to achieve similar response to the metered dose inhaler .
CONCLUSIONS	Albuterol by metered dose inhaler provided similar bronchodilation to that achieved by wet nebulization in patients with acute asthma .
CONCLUSIONS	The cumulative dose-response technique is applicable in the emergency department setting and is helpful in comparing the relative utility of various bronchodilator regimens .

###9456253
BACKGROUND	A substantial number of patients with advanced HIV infection suffer from intractable diarrhoea .
BACKGROUND	The aim of this study was to evaluate whether potent antiretroviral therapy could alleviate such diarrhoea .
METHODS	In an open randomized study the effect of the HIV protease inhibitor indinavir in combination with nucleoside analogue reverse transcriptase inhibitors on chronic HIV-related diarrhoea was investigated in 14 late-stage ( CD4 + lymphocyte count < or = 50 x 10 ( 6 ) cells/l ) HIV-infected patients .
METHODS	Data concerning stool frequency , stool consistency and antidiarrhoeal drug use were collected in daily diaries over a 24-week period .
METHODS	Endpoints of the study were reduction of stool frequency , improvement of stool consistency , weight gain , and in case of diarrhoea due to Enterocytozoon bieneusi or Cryptosporidium sp .
METHODS	disappearance of these parasites from stool .
RESULTS	Thirteen patients started the study drug indinavir .
RESULTS	One patient died after 1 week and one patient withdrew prematurely after 18 weeks .
RESULTS	Median stool frequency declined from 5.8 daily at baseline to 2.3 daily after 24 weeks ( P = 0.04 ) .
RESULTS	Stool consistency improved considerably over the study period : before treatment 56 % of stools were watery and 0 % were formed ; at week 24 these figures were 0 and 35 % , respectively .
RESULTS	Body weight increased significantly with a median increment of 6.6 kg at week 24 ( P = 0.0006 ) .
RESULTS	In two out of six patients with microsporidiosis and both patients with cryptosporidiosis , stools were free of parasites at week 24 .
RESULTS	Five out of six patients who used non-specific antidiarrhoeal medication on a regular basis prior to the study had ceased to do so at the end .
CONCLUSIONS	The use of potent antiretroviral therapy in patients with advanced HIV infection can improve chronic HIV-related diarrhoea and in some cases lead to disappearance of E. bieneusi and Cryptosporidium sp .
CONCLUSIONS	from the stools .

###25628269
OBJECTIVE	To determine the clinical performance of DAILIES TOTAL1 ( DT1 ) , Clariti 1Day ( C1D ) , and 1-DAY ACUVUE TruEye ( AVTE ) silicone hydrogel daily disposable contact lenses ( SiHy DDCLs ) .
METHODS	Eligible participants , subdivided into asymptomatic and symptomatic groups , wore each SiHy DDCLs for three consecutive days .
METHODS	Each participant attended three visits ( on day 1 at 0 hours ; on days 1 and 3 after 8 hours of wear ) per lens type .
METHODS	The order of lens wear was randomized , with at least 1 day washout between lenses .
METHODS	Lens-related performance was evaluated by assessing lens surface deposits , wettability , pre-lens noninvasive tear breakup time , lens movement , and centration ; ocular response assessments included conjunctival redness , corneal staining , and conjunctival staining and indentation .
RESULTS	Fifty-one asymptomatic and 53 symptomatic participants completed the study .
RESULTS	For all visits , the mean noninvasive tear breakup time was about 1 second longer with DT1 than with C1D and AVTE ( p < 0.01 ) .
RESULTS	Overall , the wettability of all three lenses was good ; however , DT1 was graded marginally better than the other lenses ( both p < 0.01 ) .
RESULTS	On day 3 , eyes wearing AVTE had significantly more dehydration-induced corneal staining compared with DT1 ( AVTE , 24 % ; DT1 , 11 % ; p < 0.01 ) .
RESULTS	After 8 hours , conjunctival staining was different between lenses ( greatest with C1D and least with DT1 ; all p < 0.01 ) .
RESULTS	Conjunctival indentation was more prevalent with the C1D lenses ( n = 70 ) compared with DT1 ( n = 1 ; p < 0.01 ) and AVTE ( n = 11 ; p < 0.01 ) .
RESULTS	There were no differences between asymptomatic and symptomatic lens wearers for any of the clinical parameters ( all p > 0.05 ) .
CONCLUSIONS	Each of the three SiHy DDCLs performed well .
CONCLUSIONS	Noninvasive tear breakup time was longest and wettability was greater with DT1 .
CONCLUSIONS	C1D had the most conjunctival staining conjunctival indentation .
CONCLUSIONS	There was no difference between asymptomatic and symptomatic wearers with regard to ocular response and contact lens-related parameters .
CONCLUSIONS	These results suggest that SiHy DDCLs may be an excellent contact lens modality for the symptomatic patient .

###23524528
BACKGROUND	Right ventricular function ( RVF ) is an important determinant of outcome in patients with heart failure , and those with severe RV dysfunction have worse outcome after cardiac resynchronization therapy ( CRT ) .
BACKGROUND	We used data from the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) Trial to determine whether therapy with CRT is influenced by or affects RV function and to define the relationship between RV function and outcomes .
RESULTS	A total of 1820 patients were randomly assigned to CRT plus implantable cardioverter defibrillator or implantable cardioverter defibrillator-only in a 3:2 ratio .
RESULTS	We assessed RVF as RV fractional area change by echocardiography at baseline and after 1 year of therapy ( n = 1511 and 1273 , respectively ) .
RESULTS	The median RV fractional area change was 41 % , with 10.9 % of patients < 35 % at baseline .
RESULTS	Baseline RVF did not modify the treatment effect of CRT on the primary outcome ( interaction P = 0.19 ) .
RESULTS	Randomization to CRT-implantable cardioverter defibrillator was associated with a greater improvement in RVF ( RV fractional area change 8.1 % versus 5.4 % ; P < 0.001 ) , and improvement in RVF was related to subsequent outcomes .
RESULTS	Every 5-point increase in RV fractional area change was associated with a 22 % reduction in event rates ( hazard ratio , 0.78 ; 95 % confidence interval , 0.66-0 .92 ; P = 0.003 ) , although this was not independent of the concurrent improvement in left ventricular function .
RESULTS	Baseline tricuspid regurgitant velocity , a measure of pulmonary systolic pressure , was predictive of events in a multivariate analysis ( hazard ratio , 1.86 ; 95 % confidence interval , 1.24-2 .8 ; P = 0.003 ) .
CONCLUSIONS	In this population with mild heart failure symptoms , CRT was associated with improvement in RVF , which improved in parallel with improvement in left ventricular function .
CONCLUSIONS	Patients with the best RVF at 1 year demonstrated the lowest subsequent event rates .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01294449 .

###8238153
OBJECTIVE	Our purpose was to compare maternal and fetal factors that influence the route of delivery with active management of labor and a traditional labor management protocol .
METHODS	Data were collected prospectively on 346 consecutive patients receiving active management of labor and 354 patients who were managed traditionally .
METHODS	Within each group demographic and labor characteristics of patients undergoing cesarean section were compared with those of patients having vaginal deliveries by means of the Student t test , chi 2 analysis , and stepwise logistic regression .
RESULTS	With both active management of labor and traditional labor management success in achieving vaginal delivery was related to the station of the fetal vertex at admission , the need for oxytocin augmentation of labor , the uterine response to oxytocin , the use of epidural anesthesia , and the development of chorioamnionitis .
RESULTS	By means of multiple logistic regression analysis maternal age , height , payor status , and birth weight were also identified as risk factors for cesarean section with traditional labor management but not with active management of labor .
CONCLUSIONS	Differences were identified in risk factors for cesarean section between active management and traditional labor management .
CONCLUSIONS	Active management of labor may diminish or eliminate some patient characteristics as risk factors for cesarean birth .

###18648229
BACKGROUND	Droperidol and ondansetron have previously been found to prolong the QT interval in the treatment of postoperative nausea and vomiting .
BACKGROUND	However , this adverse effect has never been confirmed and compared with both drugs under controlled conditions .
BACKGROUND	The objective was to study the effects of droperidol and ondansetron alone or in combination on QT interval duration in healthy subjects .
METHODS	Sixteen healthy volunteers , eight males and eight females , were enrolled in this prospective , double-blind , randomized , placebo-controlled study .
METHODS	Subjects received 1 mg droperidol , 4 mg ondansetron , 1 mg droperidol plus 4 mg ondansetron , or a placebo , intravenously in a crossover design .
METHODS	Fridericia-corrected QT interval ( QTcF ) and plasma concentrations were measured repeatedly during 10 h at each study period .
METHODS	The primary endpoint was the maximal placebo time-matched and baseline-subtracted QTcF prolongation ( DeltaDeltaQTcF ) .
RESULTS	Compared with placebo , both droperidol and ondansetron significantly prolonged the QTcF interval .
RESULTS	DeltaDeltaQTcF prolongation was 25 + / - 8 ms after droperidol , significantly greater than the 17 + / - 10-ms prolongation with ondansetron ( P = 0.014 ) .
RESULTS	The combination of droperidol and ondansetron significantly increased the mean maximal DeltaDeltaQTcF by 28 + / - 10 ms. The combination induced greater QTcF prolongation compared with ondansetron alone ( P = 0.001 ) , but not with droperidol alone ( P = 0.33 ) .
RESULTS	There was no significant pharmacokinetic interaction between droperidol and ondansetron .
CONCLUSIONS	Under controlled conditions , both droperidol and ondansetron either alone or in combination induced significant marked QTc interval prolongation .
CONCLUSIONS	However , the combination of both drugs did not significantly increase QTc prolongation compared with that induced by droperidol alone .

###19135997
OBJECTIVE	A fast-track program is a multimodal approach for patients undergoing colonic surgery that combines stringent regimens of perioperative care ( fluid restriction , optimized analgesia , forced mobilization , and early oral feeding ) to reduce perioperative morbidity , hospital stay , and cost .
OBJECTIVE	We investigated the impact of a fast-track protocol on postoperative morbidity in patients after open colonic surgery .
METHODS	A randomized trial of patients in 4 teaching hospitals in Switzerland included 156 patients undergoing elective open colonic surgery who were assigned to either a fast-track program or standard care .
METHODS	The primary end point was the 30-day complication rate .
METHODS	Secondary end points were severity of complications , hospital stay , and compliance with the fast-track protocol .
RESULTS	The fast-track protocol significantly decreased the number of complications ( 16 of 76 in the fast-track group vs 37 of 75 in the standard care group ; P = .0014 ) , resulting in shorter hospital stays ( median , 5 days ; range , 2-30 vs 9 days , respectively ; range , 6-30 ; P < .0001 ) .
RESULTS	There was a trend toward less severe complications in the fast-track group .
RESULTS	A multiple logistic regression analysis revealed fluid administration greater than the restriction limits ( odds ratio , 4.198 ; 95 % confidence interval , 1.7-10 .366 ; P = .002 ) and a nonfunctioning epidural analgesia ( odds ratio , 3.365 ; 95 % confidence interval , 1.367-8 .283 ; P = .008 ) as independent predictors of postoperative complications .
CONCLUSIONS	The fast-track program reduces the rate of postoperative complications and length of hospital stay and should be considered as standard care .
CONCLUSIONS	Fluid restriction and an effective epidural analgesia are the key factors that determine outcome of the fast-track program .

###10485075
OBJECTIVE	To compare manganese-DPDP-enhanced and gadolinium-DTPA-enhanced MR imaging in patients suspected of having pancreatic cancer .
METHODS	Fifteen patients who underwent MR imaging for suspected pancreatic cancer and received gadolinium-DTPA took part in a clinical phase III trial in which the efficacy of manganese-DPDP for detection of pancreatic cancer was evaluated .
METHODS	T1-weighted gradient-echo ( GRE ) images with and without fat suppression were used .
METHODS	Signal-to-noise ratio and contrast-to-noise ratio were calculated before and after the administration of each contrast agent .
METHODS	Image quality was assessed using a four-step score ; delineation of the normal pancreas was assessed by two readers in consensus .
RESULTS	In terms of pancreatic signal-to-noise ratio , only gadolinium-DTPA-enhanced fat-suppressed and non-fat-suppressed GRE imaging showed a significant ( P < 0.001 ) increase ( 72 % and 61 % , respectively ) .
RESULTS	In the patients with a focal pancreatic lesion ( n = 14 ) , a significant increase in contrast-to-noise ratio was found only in manganese-DPDP-enhanced GRE imaging without ( 106 % ) and with ( 82 % ) fat saturation .
RESULTS	Qualitative image analysis demonstrated a significant improvement of manganese-DPDP-enhanced fat-suppressed MR images in delineating the pancreatic parenchyma ( P < 0.01 ) as well as pancreatic tumors ( P < 0.01 ) .
CONCLUSIONS	T1-weighted manganese-DPDP-enhanced GRE imaging with fat saturation should be regarded as the most suitable combination for detecting a pancreatic lesion .

###16318613
OBJECTIVE	To determine the effect of routine intraoperative cervical dilatation during elective cesarean section on maternal morbidity .
METHODS	Patients with even numbers in the operative elective cesarean section list were included in the study .
METHODS	Of these , every second patient underwent intraoperative cervical dilatation .
METHODS	All participants in the two groups had otherwise similar preoperative care , operative procedures and subsequent clinical care .
METHODS	Blood loss was estimated and maternal infection status was assessed postoperatively by any rise of temperature or wound infection .
RESULTS	Of the 131 patients included in the study , 67 underwent cervical dilation and 64 served as controls .
RESULTS	There was no significant difference in postoperative hemoglobin , incidence of fever , or wound infection between the two groups .
RESULTS	Only two of the cervical dilation group and one control patient developed postoperative fever .
RESULTS	A hemoglobin drop of more than 0.5 g/dL was noted in 27 and 26 patients in the cervical dilation and the no dilation groups , respectively ( NS ) .
RESULTS	None of the study patients had signs of wound infection .
CONCLUSIONS	Intraoperative cervical dilatation during elective cesarean section did not reduce the risk of postoperative maternal fever , wound infection or change in hemoglobin concentration .

###16036503
OBJECTIVE	Gastric acid inhibition is beneficial in the management of peptic ulcer bleeding ( PUB ) .
OBJECTIVE	The aim of this double-blind study was to test whether somatostatin ( SST ) increases intragastric pH in PUB as compared with pantoprazole ( PAN ) and placebo ( PLA ) .
METHODS	Eligible patients were randomized to receive SST ( 500 microg/h +250 microg bolus ) , or PAN ( 8 mg/h +80 mg bolus ) or PLA ( normal saline ) i.v. , for 24 h. All patients underwent gastric pH monitoring during the infusion of the trial drugs .
RESULTS	The three groups ( SST , n = 14 ; PAN , n = 14 ; PLA , n = 15 ) were comparable for age , gender , aetiology of PUB and laboratory data at admission .
RESULTS	Mean ( + / - SE ) baseline pH levels in the fundus increased during the administration of the trial drugs ( SST : 1.94 + / -0.18 to 6.13 + / -0.37 , p < 0.0001 ; PAN : 1.93 + / -0.16 to 5.65 + / -0.37 , p < 0.0001 ; PLA : 1.86 + / -0.12 to 2.10 + / -0.15 , p = 0.0917 ) .
RESULTS	During the first 12 h of infusion , the mean ( + / - SE ) percentage time spent above pH 4.0 and 5.4 was higher with SST versus PAN ( 84.4 % + / -4.8 versus 55.1 % + / -8.3 , p = 0.0049 and 74.2 % + / -6.5 versus 47.1 % + / -8.3 , p = 0.0163 , respectively ) and there was a trend favouring the SST group regarding the time spent above pH 6.0 and 6.8 ( 65.7 % + / -6.4 versus 43.3 % + / -8.2 , p = 0.0669 and 49.2 % + / -7.7 versus 28.4 + / -6.6 , p = 0.0738 , respectively ) .
CONCLUSIONS	In PUB , both SST and PAN inhibit gastric acid secretion as compared with placebo .
CONCLUSIONS	However , during the first 12 h of the infusion , SST was more effective than PAN in maintaining high intragastric pH. These results may provide a rationale for the administration of SST in PUB .

###22337277
BACKGROUND	There is evidence that percutaneous dilatational tracheotomy ( PDT ) can be safely performed in patients with severe coagulation disorders if these are carefully corrected immediately before the procedure .
BACKGROUND	However , it is currently unclear whether PDT can be performed safely in patients in an Intensive Care Unit ( ICU ) with uncorrected mild coagulation disorders .
METHODS	In a randomised controlled trial we determined the effect of correction of mild coagulation disorders on bleeding during and after PDT .
METHODS	ICU patients planned for bedside PDT with : ( i ) a prothrombin time ( PT ) between 14.7-20 .0 seconds , ( ii ) a platelet count between 40-10010 ( 9 ) / L and/or ( iii ) active treatment with acetylsalicylic acid were randomised to receive infusion with fresh-frozen plasma ( FFP ) and/or platelets ( `` correction '' ) versus no transfusion ( `` no correction '' ) before PDT .
RESULTS	We randomised 35 patients to the `` correction '' group and 37 patients to the `` no correction '' group .
RESULTS	In patients who received FFP , the decrease in PT was marginal ( mean decrease 0.400.56 seconds ) ; the median increase in platelet counts after transfusion of platelets was 35 [ 11-47 ] x10 ( 9 ) / L.
RESULTS	The median blood loss was 3 [ IQR : 1-6 ] grams in the `` correction '' group and 3 [ IQR : 2-6 ] grams in the `` no correction '' group ( P = 0.96 ) .
CONCLUSIONS	Bleeding during and after bedside PDT in ICU patients with mild coagulation disorders is rare in our setting .
CONCLUSIONS	Correction of subclinical coagulation disorders by transfusion of FFP and/or platelets does not affect bleeding .

###25332483
BACKGROUND	There is evidence to support the use of lipid-based nutrient supplements ( LNSs ) to promote child growth and development in low-income countries , but there is also a concern regarding the safety of using iron-fortified products in malaria-endemic areas .
OBJECTIVE	The objective of this study was to test the hypothesis that 6 - to 18-mo-old rural Malawian children receiving iron-containing ( 6 mg/d ) LNSs would not have excess morbidity compared with infants receiving no supplementation .
METHODS	A randomized controlled trial allocated 840 children to receive daily supplementation with 54 g/d LNS with milk protein base ( milk-LNS ) , 54 g/d LNS with soy protein base ( soy-LNS ) , 71 g/d corn-soy blend ( CSB ) , or no supplementation from 6 to 18 mo of age .
METHODS	Morbidity was compared using a non-inferiority margin set at 20 % excess morbidity in supplemented groups compared with the nonsupplemented group .
RESULTS	Baseline characteristics were similar across groups .
RESULTS	The proportion of days with febrile illness between 6 and 18 mo was 4.9 % , and there were no differences between the groups : 4.9 % ( 95 % CI : 4.3 , 5.5 % ) , 4.5 % ( 95 % CI : 3.9 , 5.1 % ) , 4.7 % ( 95 % CI : 4.1 , 5.3 % ) , and 5.5 % ( 95 % CI : 4.7-6 .3 % ) in the milk-LNS , soy-LNS , CSB , and control groups , respectively .
RESULTS	The proportion of days with respiratory problems and diarrhea between 6 and 18 mo also did not differ between groups .
RESULTS	Compared with controls , the incident rate ratio ( 95 % CI ) for clinical malaria was 0.80 ( 0.59 , 1.09 ) , 0.77 ( 0.56 , 1.06 ) , and 0.79 ( 0.58 , 1.08 ) in milk-LNS , soy-LNS , and CSB , respectively , with 95 % CIs confirming non-inferiority .
RESULTS	The incidence of febrile episodes , diarrhea , respiratory problems or admission to hospital , prevalence of malaria parasitemia throughout the follow-up , and mean change in hemoglobin concentration from baseline were also similar between the groups .
CONCLUSIONS	Daily supplementation with 54 g of milk-based or soy protein-based LNS or 71 g of CSB did not result in increases in malaria or respiratory morbidity in children in a malaria-endemic setting .
CONCLUSIONS	However , we could not conclude whether LNSs did or did not increase diarrheal morbidity .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00524446 .

###17949629
OBJECTIVE	To evaluate a primary care protocol for intensive monitoring of cardiovascular risk ( CVR ) factors in type-2 diabetes patients versus usual care .
METHODS	Randomised trial with clusters .
METHODS	Primary care clinics .
METHODS	Sixty family physicians .
METHODS	Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients .
METHODS	Follow-up lasted 12 months .
METHODS	Data on HbA1C , CVR factors and CVR were collected at the start of the study and at 12 months .
RESULTS	In all , 188 patients ( 94 intervention group and 94 control group ) were included .
RESULTS	At baseline measurement , CVR in control group ( CG ) was 36.3 % ( 95 % CI , 33.9 % -38.6 % ) ; and in intervention group ( IG ) , 35.9 % ( 95 % CI , 33.5 % -38.4 % ) , with no significant differences between groups .
RESULTS	At one year , CVR in CG was 33.1 % ( 95 % CI , 30 % -36.1 % ) and in IG 30.5 % ( 95 % CI , 27.8 % -33.2 % ) .
RESULTS	The CVR difference between baseline and 1-year measurements was 2.9 % ( 95 % CI , 0.2 % -5.7 % ) in CG and 5.4 % ( 95 % CI , 2.8 % -7.1 % ) in IG .
CONCLUSIONS	Although improvement of CVR is greater in the IG , the difference between the two groups is not significant .
CONCLUSIONS	The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment .

###9177508
OBJECTIVE	To compare endoscopic variceal ligation ( EVL ) with a combination of EVL and endoscopic scelerotherapy ( EST ) in the secondary prophylaxis of esophageal variceal bleeding .
METHODS	Fifty patients with esophageal varices due to cirrhosis of the liver ( 38 ) , noncirrhotic portal fibrosis ( 7 ) , or extrahepatic portal venous obstruction ( 5 ) were included in the study .
METHODS	These 50 patients were randomized to receive either EVL alone or a combination of EVL and EST for variceal eradication .
METHODS	Twenty-one patients received EVL alone ( group A ) , and 23 patients received EVL and EST ( group B ) .
METHODS	In group B , EVLs were performed until the varices were reduced to grade II size , and , subsequently , these patients underwent low-dose sclerotherapy with 1 % polidocanol until variceal eradication was achieved .
RESULTS	Combined EVL and EST treatment eradicated the varices in a significantly greater number of patients then EVL alone ( 87 % vs. 24 % ; p < 0.05 ) .
RESULTS	However , significantly more endoscopic sessions were required with combined treatment than with EVL alone ( 5.87 + / - 2.32 vs. 4.28 + / - 1.82 ; p < 0.05 ) .
RESULTS	Rebleeding episodes before variceal eradication were similar in the two groups ( 19 % vs. 22 % ) .
RESULTS	The complications were similar in both the EVL and the EVL-plus-EST group , ie. , deep ulcers ( 16 % vs. 20 % ) , transient dysphagia ( 20 % vs. 32 % ) , and stricture ( 4 % vs. 8 % ) .
CONCLUSIONS	Thus , combined EVL and EST treatment eradicates varices in a significantly larger number of patients than EVL alone , with no extra complications .

###12459926
BACKGROUND	Dementia includes not only cognitive deficit but may also include psychiatric and behavioral symptoms .
BACKGROUND	These psychological symptoms of dementia require specific treatment without deleterious effects on cognitive functions .
OBJECTIVE	The aim of the present study was to assess the effects of a single dose of risperidone ( 0.25 or 0.5 mg ) on psychomotor performances and cognitive functions compared to a placebo and to a positive control , lorazepam 1 mg , in 12 healthy elderly subjects .
METHODS	This study was a randomized , double-blind , four-way crossover clinical trial involving four 8-h long treatment periods .
METHODS	The pharmacodynamic assessment criteria included a battery of psychomotor tests , a subjective evaluation and an electroencephalogram .
METHODS	Safety was evaluated by clinical laboratory tests , electrocardiogram and recording of adverse events .
METHODS	Concentrations of risperidone , 9-hydroxy-risperidone and lorazepam were determined before and 2 h after dosing .
METHODS	RESULTS .
METHODS	Few significant effects were observed on psychomotor tests with risperidone at all dosages .
METHODS	Risperidone was devoid of any deleterious effects on speed of reaction , vigilance and sustained attention , working and long-term memory and increased cortical arousal .
METHODS	Risperidone demonstrated minor impairment on motor activity ( decreased finger taping ) , postural stability , and information processing ( impaired digit symbol substitution ) .
METHODS	Contentedness subjective evaluation was decreased with risperidone 0.5 mg , 6 h after dosing .
METHODS	No significant difference was observed on EEG frequencies and no sedative activity was detected with risperidone .
METHODS	At 2 h after dosing , risperidone plasma concentrations were 1.54 + / -0.99 ng/ml and 2.80 + / -1.41 ng/ml ; 9-hydroxy-risperidone concentrations were 0.77 + / -0.46 ng/ml and 1.54 + / -0.85 ng/ml after intake of 0.25 mg and 0.5 mg doses , respectively .
METHODS	Well-known detrimental effects of lorazepam on psychomotor performances were observed and sedative effects were confirmed by the EEG findings .
METHODS	At 2 h following lorazepam 1 mg administration , plasma concentrations were 13.40 + / -2.17 ng/ml .
METHODS	None of both compounds induced serious adverse events .
CONCLUSIONS	The results of this clinical trial conducted on healthy subjects demonstrated that low doses of risperidone , but not low doses of lorazepam , did not disturb the cognitive functions in the elderly .

###10093945
BACKGROUND	Despite concerns about safety in children , fluoroquinolone antibiotics have become the treatment of choice in patients with multidrug-resistant typhoid fever in Vietnam .
BACKGROUND	However , quinolone-resistant strains of Salmonella typhi have recently been reported from Vietnam ; and if quinolone resistance becomes established , alternative oral treatment options will be needed .
OBJECTIVE	Cefixime , an orally administered third generation cephalosporin , was compared with ofloxacin for the treatment of uncomplicated typhoid fever in children .
METHODS	In an open trial children with suspected typhoid fever were randomized to receive either ofloxacin ( 10 mg/kg/day in two divided doses ) for 5 days or cefixime ( 20 mg/kg/day in two divided doses ) for 7 days .
RESULTS	S. typhi was isolated from 82 patients ( 44 in the cefixime group , 38 in the ofloxacin group ) and 70 ( 85 % ) of the isolates were multidrug-resistant .
RESULTS	Median ( 95 % confidence interval , range ) fever clearance times were 4.4 ( 4 to 5.2 , 0.2 to 9.9 ) days for ofloxacin recipients and 8.5 ( 4.2 to 9 , 1.8 to 15.2 ) days for cefixime-treated patients ( P < 0.0001 ) .
RESULTS	There were 11 treatment failures ( 10 acute and one relapse ) in the cefixime group and 1 acute treatment failure in the ofloxacin group ( mean difference , 22 % ; 95 % confidence interval , 9 to 36 % ) .
CONCLUSIONS	Short course treatment with cefixime may provide a useful alternative treatment in cases of uncomplicated typhoid fever in children , but it is less effective than short course treatment with ofloxacin .

###9588408
BACKGROUND	Patients with acute myocardial infarction ( AMI ) who are not eligible for thrombolytic therapy or primary coronary angioplasty are distinguished by advanced age , complicated medical histories , relatively frequent use of prior revascularization procedures , and worse outcomes than their counterparts who are eligible for reperfusion therapy .
RESULTS	The purpose of this randomized , controlled trial was to determine whether RheothRx , a hemorheologic agent , reduced myocardial infarct size and improved left ventricular function in patients who had suspected AMI at the time of hospital admission and were not eligible for reperfusion therapy .
RESULTS	Patients were randomly assigned to RheothRx ( n = 97 ) or placebo ( n = 99 ) .
RESULTS	Patients in the two groups were similar with respect to age , sex , medical history , and clinical presentation .
RESULTS	Enzyme evidence of AMI was present in 69 % of the treatment group and 70 % of the placebo group .
RESULTS	Infarct size measured before hospital discharge was similar in the two groups ( 14.1 % + / - 18.5 % vs 11.7 % + / - 14.1 % , p = 0.60 ) , although left ventricular ejection fraction was lower in the treatment group ( 47 + / - 14 vs 52 + / - 11 , p = 0.026 ) .
RESULTS	Hospital mortality rate was 11.3 % and 7.1 % in patients receiving RheothRx and patients receiving placebo , respectively ( p = 0.30 ) .
RESULTS	There was a higher occurrence of acute renal dysfunction in the RheothRx group ( 12 % vs 2 % , p = 0.005 ) .
RESULTS	Because of changes in drug dosage necessitated by the occurrence of acute renal dysfunction , the trial was stopped .
CONCLUSIONS	In this study of patients who had suspected AMI and were not eligible for thrombolytic therapy , RheothRx did not decrease infarct size or favorably alter outcome .
CONCLUSIONS	The need for effective treatment for this large patient population remains largely unmet .

###17348993
BACKGROUND	Photodynamic therapy ( PDT ) is commonly used to treat actinic keratoses , superficial cutaneous carcinoma , photodamage , and/or acne .
BACKGROUND	The aim of this study was to compare the usefulness of Avne thermal spring water ( ATSW ) , a low mineral content spring water , to a high mineral content spring water .
BACKGROUND	We evaluated post-PDT clinical symptoms and findings when used as an adjunctive therapy in postprocedure skin care .
METHODS	A double-blind monocentric comparative study was conducted on 25 patients suffering from either vulgaris acne or photodamage with or without actinic keratoses .
METHODS	The patients were treated with 5-aminolevulinic acid ( 5-ALA ) activated with an intense pulsed light and/or blue light source .
METHODS	Patients were randomized so that 12 patients treated their faces with ATSW and 13 were treated with a comparative water spray .
METHODS	Clinical signs were evaluated by the investigator at day 0 , before and 15 min after the first spraying , at days 2 , 4 , and 7 , and each day from day 0 to day 6 by patients .
METHODS	Clinical signs ( erythema , stinging , pruritus , pain , and tightening ) were evaluated by the use of a 4-point grading scale .
RESULTS	The intragroup analysis showed that pain was significantly reduced by ATSW spraying at days 2 , 4 , and 7 .
RESULTS	The evaluation by patients showed that only ATSW alleviates pain from day 3 to day 6 .
RESULTS	The between-group analysis revealed that pruritus was significantly reduced by ATSW at day 7 .
RESULTS	Erythema , stinging , and tightening were not significantly reduced by both waters .
RESULTS	Patients wished to continue using ATSW in 83 % of cases .
CONCLUSIONS	This comparative clinical trial demonstrates that ATSW , a low mineral content spring water , can be useful after ALA-PDT in reducing postprocedure cutaneous inflammation and patient discomfort better than a high mineral content spring water .

###21981704
OBJECTIVE	To investigate the efficacy of applying a Montessori intervention to improve the eating ability and nutritional status of residents with dementia in long-term care facilities .
BACKGROUND	An early intervention for eating difficulties in patients with dementia can give them a better chance of maintaining independence and reduce the risk of malnutrition .
METHODS	An experimental crossover design was employed .
METHODS	Twenty-nine residents were chosen from two dementia special care units in metropolitan Taipei .
METHODS	To avoid contamination between participants in units using both Montessori and control interventions , two dementia special care units were randomly assigned into Montessori intervention ( I1 ) and routine activities ( I2 ) sequence groups .
METHODS	A two-period crossover design was used , with 15 residents assigned to Montessori intervention sequence I ( I1 , I2 ) and 14 residents assigned to Montessori intervention sequence II ( I2 , I1 ) .
METHODS	On each intervention day , residents were given their assigned intervention .
METHODS	Montessori intervention was provided in 30-min sessions once every day , three days per week , for eight weeks .
METHODS	There was a two-week washout period between each intervention .
RESULTS	There was a significant reduction in the Edinburgh Feeding Evaluation in Dementia score for the Montessori intervention period but not for the routine activities period , while the mean differences for the Eating Behavior Scale score , self-feeding frequency and self-feeding time were significantly higher than those of the routine activities period .
RESULTS	Except for the Mini-Nutritional Assessment score post-test being significantly less than the pre-test for the routine activities period , no significant differences for any other variables were found for the routine activities period .
CONCLUSIONS	This study confirms the efficacy of a Montessori intervention protocol on eating ability of residents with dementia .
CONCLUSIONS	Adopting Montessori intervention protocols to maintain residents ' self-feeding ability in clinical practice is recommended .
CONCLUSIONS	Montessori-based activities could provide caregivers with an evidence-based nursing strategy to deal with eating difficulties of people with dementia .

###19643364
BACKGROUND	Continuous aortic flow augmentation ( CAFA ) therapy with the Cancion System ( Orqis Medical , Inc ) was shown to effectively unload the left ventricle in dogs with chronic heart failure ( HF ) .
BACKGROUND	This study compared the extent of acute left ventricular ( LV ) unloading elicited by CAFA to that elicited by intra-aortic balloon counterpulsation ( IABP ) in normotensive dogs with coronary microembolization-induced HF .
RESULTS	Seven HF dogs were studied with both CAFA and IABP in random order and 1 week apart .
RESULTS	In both instances , active therapy was maintained for 4 hours .
RESULTS	The Cancion system was positioned using a dual femoral approach configuration with a constant pump flow of 250 mL/min .
RESULTS	In all dogs and with both devices , LV end-diastolic pressure ( EDP ) , LV end-systolic volume ( ESV ) , and LV ejection fraction ( EF ) were measured at baseline and at 2 and 4 hours after instituting CAFA or IABP .
RESULTS	Plasma samples obtained at the end of 4 hours of therapy were used to measure a host of circulating biomarkers that included neurohormones , cytokines , and A-type and B-type natriuretic peptides .
RESULTS	IABP had no significant effects on LVEDP , LVESV , and LVEF .
RESULTS	In contrast , CAFA significantly decreased LVEDP and LVESV and increased LVEF .
RESULTS	Compared with IABP , CAFA was accompanied by significant improvements in circulating levels of neurohormones , cytokines , and natriuretic peptides .
CONCLUSIONS	The results indicate that CAFA is more effective than IABP in achieving acute global LV unloading in dogs with chronic HF not complicated by ongoing myocardial ischemia or cardiogenic shock .

###1610577
OBJECTIVE	To compare the sedative , anxiolytic , and amnestic effects , as well as the recovery characteristics , when midazolam ( vs. a placebo ) is administered to patients receiving a propofol infusion for sedation during local anesthesia .
METHODS	Randomized , double-blind , placebo-controlled study to evaluate the perioperative effects of intravenous ( IV ) midazolam .
METHODS	Outpatient surgery center of a university-affiliated medical center .
METHODS	One hundred thirty-nine consenting , ASA physical status I , II , and III outpatients undergoing elective surgical procedures under local anesthesia .
METHODS	Patients were randomly assigned to receive either midazolam 2 mg IV or saline 2 ml IV prior to injection of local anesthesia .
METHODS	Intraoperative sedation was maintained using a variable-rate propofol infusion .
RESULTS	Preoperative assessment of sedation , anxiety , and amnesia was performed before and after IV midazolam .
RESULTS	Intraoperative evaluations included level of sedation , as well as cardiovascular and respiratory measurements , at 1 - to 5-minute intervals during the operation .
RESULTS	Postoperatively , recovery of psychomotor function and patients ' subjective feelings were assessed using the visual analog scale and questionnaires .
RESULTS	Amnesia was assessed using picture recall during the perioperative period .
RESULTS	In the operating room , midazolam 2 mg IV , compared with the placebo , produced a significantly greater increase in patients ' level of sedation ( 7 + / - 13 mm to 49 + / - 21 mm for midazolam vs. 8 + / - 11 mm to 19 + / - 21 mm for the placebo ; p less than 0.01 ) and a greater decrease in anxiety level ( 62 + / - 25 mm to 21 + / - 21 mm for midazolam vs. 54 + / - 27 mm to 53 + / - 22 mm for the placebo ; p less than 0.01 ) .
RESULTS	Although the propofol dosage requirements to maintain comparable levels of sedation were similar in both groups , midazolam decreased patients ' recall of intraoperative events ( e.g. , propofol-induced pain on injection and discomfort with local anesthetic injection ) without significantly altering cardiorespiratory parameters or prolonging times to ambulation and discharge from the outpatient facility .
CONCLUSIONS	Premedication with midazolam 2 mg IV produced increased sedation , amnesia , and anxiolysis when administered immediately prior to the propofol infusion as part of a sedation technique for outpatient surgery .
CONCLUSIONS	This combination did not prolong the recovery room stay when compared with propofol alone .

###18363894
BACKGROUND	Two phase III studies have evaluated mesalazine ( mesalamine ) with MMX ( Multi Matrix System ) technology in patients with active mild-to-moderate ulcerative colitis .
OBJECTIVE	To determine the efficacy of MMX mesalazine for the induction of clinical and endoscopic remission in specific subgroups of patients with active , mild-to-moderate ulcerative colitis .
METHODS	Data from two double-blind , placebo-controlled trials were analysed ( 517 out-patients ) .
METHODS	Patients were randomized to receive MMX mesalazine [ 2.4 g/day ( once daily or 1.2 g twice daily ) or 4.8 g/day ( once daily ) ] or placebo for 8 weeks .
RESULTS	The percentages of patients treated with MMX mesalazine , 2.4 or 4.8 g/day , in clinical and endoscopic remission at week 8 were similar and significantly ( P < 0.05 ) greater than placebo in subgroups stratified by disease extent , disease severity and gender and among patients not previously receiving low-dose 5-aminosalicylic acid .
RESULTS	Among patients transferring directly from prior low-dose oral 5-aminosalicylic acid , MMX mesalazine 4.8 g/day was significantly ( P = 0.018 ) more effective than placebo in inducing clinical and endoscopic remission .
RESULTS	Efficacy over placebo did not reach significance in patients transferring directly to MMX mesalazine 2.4 g/day .
CONCLUSIONS	MMX mesalazine is effective in active UC regardless of disease extent , disease severity , gender and previous , low-dose , 5-ASA therapy .

###22194637
OBJECTIVE	Bangladesh has the highest level of incidence and mortality rates due to cervical cancer among women .
OBJECTIVE	The prevalence of cervical cancer in Bangladeshi women is 25-30/100 ,000 .
OBJECTIVE	Human papillomavirus is an important cause of cervical cancer .
OBJECTIVE	The study was conducted to assess the immunogenicity and safety profile of human papillomavirus-16 / 18 AS04-adjuvanted cervical cancer vaccines in healthy Bangladeshi girls aged 9-13 years .
OBJECTIVE	Procedure This was a randomized ( 3:1 ) controlled trial with two parallel groups , the vaccine and control groups , that included 67 participants in Bangladesh .
OBJECTIVE	Subjects were given GlaxoSmithKline human papillomavirus-16 / 18 AS04-adjuvanted cervical cancer vaccine ( and controls no vaccine ) at the first day of vaccination ( Day 0 ) , at 1 - and 6-month schedule and followed up until 7 months .
OBJECTIVE	Blood samples were taken for human papillomavirus antibody at enrollment and 1 month post-schedule at Month 7 from both subjects and controls .
OBJECTIVE	Safety data were gathered throughout the study period .
RESULTS	Fifty subjects received vaccine at Day 0 , 1 month and 6 months .
RESULTS	All subjects were initially sero-negative in the vaccine group , and developed sero-conversion for human papillomavirus-16 and -18 antibodies except for one at Month 7 .
RESULTS	Seventeen controls did not receive vaccine .
RESULTS	Clients were followed up for serious medically important events and blood samples were taken for human papillomavirus antibody detection at Day 0 and Month 7 .
RESULTS	Sero-conversion was found in 97.5 % of subjects and no sero-conversion was found in the controls .
RESULTS	Bivalent human papillomavirus vaccine was generally well tolerated , with no vaccine-related serious adverse experiences .
CONCLUSIONS	The human papillomavirus-16 / 18 AS04-adjuvanted vaccine was generally well tolerated and highly immunogenic when administered to young adolescent females and could be a promising tool for the prevention and control of cervical cancer in Bangladesh .

###19032172
OBJECTIVE	The aim was to evaluate the clinical effectiveness , pharmacodynamics and pharmacokinetics of a range of Tincture of Opium ( TOP ) doses in the management of opioid withdrawal .
METHODS	Forty-five opium-dependent Thai subjects were allocated to three dosing groups ( 6.66 , 13.3 and 20 mg morphine equivalents , twice daily ) depending on their self-reported prior opium use .
METHODS	On day 5 of dosing subjects underwent an interdosing interval study where blood , withdrawal scores , heart rate and blood pressure ( BP ) were collected at 0 , 1 , 3 and 8 h. Plasma morphine concentrations were quantified by high-performance liquid chromatography , and plasma morphine-3-glucuronide ( M3G ) and morphine-6-glucuronide ( M6G ) concentrations by LCMS .
RESULTS	Thirty-two subjects completed the study .
RESULTS	Withdrawal scores were low for all subjects ( range 9-23 % of maximum response ) .
RESULTS	There were dose-dependent changes in both systolic and diastolic BP ( P = 0.021 and P = 0.01 , respectively ) , but these were not considered clinically significant .
RESULTS	There were no effects of dose on respiratory rate .
RESULTS	Plasma morphine concentrations changed significantly across the interdosing interval ( P = 0.0001 ) , rising to a maximum at 1 h after dosing .
RESULTS	Plasma morphine concentrations also differed according to dose ( P < 0.05 ) .
RESULTS	The mean ratios of the morphine glucuronides were found to be : M3G/M6G = 7.7 , M3G/morphine = 35.6 and M6G/morphine = 4.9 , values comparable to those previously reported .
CONCLUSIONS	The management of opioid withdrawal can be achieved , with minimal adverse effects , by using flexible dosing of TOP .

###23475636
BACKGROUND	We report cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel observed in the phase III study CLEOPATRA in patients with HER2-positive first-line metastatic breast cancer ( MBC ) .
METHODS	Left ventricular ejection fraction ( LVEF ) 50 % and ECOG performance status of 0 or 1 were required for study entry .
METHODS	During the study , LVEF assessments took place every 9 weeks .
METHODS	Pertuzumab/placebo was given at 840 mg , then 420 mg q3w ; trastuzumab was administered at 8 mg/kg , then 6 mg/kg q3w , and docetaxel was initiated at 75 mg/m ( 2 ) q3w .
RESULTS	The incidence of cardiac adverse events ( all grades ) was 16.4 % in the placebo arm and 14.5 % in the pertuzumab arm , with left ventricular systolic dysfunction ( LVSD , all grades ) being the most frequently reported event ( 8.3 % versus 4.4 % in the placebo and pertuzumab arm ) .
RESULTS	Declines in LVEF by 10 % points from baseline and to < 50 % were reported in 6.6 % and 3.8 % of patients in the placebo and pertuzumab arm , respectively .
RESULTS	Seventy-two percent ( placebo arm ) and 86.7 % ( pertuzumab arm ) of those patients recovered to a value 50 % .
RESULTS	The incidence of symptomatic LVSD was low , occurring in 1.8 % ( n = 7 ) versus 1.0 % ( n = 4 ) of patients in the placebo and pertuzumab arm .
RESULTS	In 8/11 patients , the symptomatic LVSD had resolved at data cutoff .
CONCLUSIONS	The combination of pertuzumab plus trastuzumab plus docetaxel did not increase the incidence of cardiac adverse events , including LVSD , compared with the control arm in HER2-positive MBC .
CONCLUSIONS	The majority of cardiac adverse events were reversible .

###19245728
BACKGROUND	Ambulatory oxygen is an important component of long-term oxygen therapy .
BACKGROUND	Pulse-dose technology conserves oxygen and thus increases the operation time of a portable oxygen system .
METHODS	We tested 4 ambulatory oxygen systems ( Helios , HomeFill , FreeStyle , and the compressed-oxygen cylinder system we regularly provide for long-term oxygen therapy at our Veterans Affairs hospital ) with 39 subjects with stage-IV chronic obstructive pulmonary disease .
METHODS	Each subject performed one 6-min walk test with each oxygen system , and we measured blood oxygen saturation ( via pulse oximetry [ S ( pO ( 2 ) ) ] ) , heart rate , and modified Borg dyspnea score , and surveyed the subjects ' preferences about the oxygen systems .
METHODS	We also studied whether the 2 systems that provide gas with a lower oxygen concentration ( from a home concentrator or portable concentrator ) showed any evidence of not providing adequate oxygenation .
RESULTS	With all 4 systems the mean pre-walk S ( pO ( 2 ) ) at the prescribed pulse-dose setting was 95-96 % .
RESULTS	The mean post-walk S ( pO ( 2 ) ) was 88-90 % after each of the 4 walk tests .
RESULTS	Between the 4 systems there were no statistically significant differences between the pre-walk-versus-post-walk S ( pO ( 2 ) ) ( = .42 ) .
RESULTS	With each system , the pre-walk-versus-post-walk S ( pO ( 2 ) ) difference was between -8 % and -6 % .
CONCLUSIONS	Between these 4 ambulatory oxygen systems there were no significant differences in S ( pO ( 2 ) ) , walk time , or walk distance , and there was no evidence of inadequate oxygenation with the 2 systems that provide a lower oxygen concentration .

###23347793
BACKGROUND	Diabetic Macular Edema ( DME ) is a common cause of impaired vision and blindness amongst diabetics .
BACKGROUND	If not detected and treated early , the resulting vision loss can lead to considerable health costs and decreased health-related quality of life ( HRQoL ) .
BACKGROUND	The aim of this study was to provide evidence of the psychometric properties of the National Eye Institute - Visual Functioning Questionnaire ( VFQ-25 ) for use in a cohort of DME patients who participated in a clinical efficacy and safety trial of pegaptinib sodium ( Macugen ) .
METHODS	A phase 2/3 randomised , double masked trial evaluated pegaptanib injection versus sham injection in patients with DME .
METHODS	The analysis was conducted using baseline HRQoL data of the VFQ-25 and the EQ-5D , on a modified intent-to-treat sample of 235 patients .
METHODS	These measures were administered by a trained interviewer by telephone in all but one of the study countries , where face-to-face interviews were conducted in the clinic .
METHODS	The measures were completed in the week prior to baseline , and after 54 weeks of treatment .
METHODS	Distance visual acuity , measured according to the Early Treatment Diabetic Retinopathy Study ( ETDRS ) , was assessed at all time points .
METHODS	Psychometric properties of the VFQ-25 assessed included domain structure , reliability , concurrent and construct validity , responsiveness .
RESULTS	The VFQ-25 was found to consist of 11 domains slightly different than those proposed .
RESULTS	Nevertheless , none of the eight established multi-item scales met the criterion for further splitting and the VFQ-25 was scored as in the developers ' instructions .
RESULTS	Internal consistency reliability was demonstrated for six out of the eight original multi-item scales , with Cronbach 's alpha ranging from 0.58 ( Distance Activities ) to 0.85 ( Vision Specific : Dependency ) .
RESULTS	The VFQ-25 domains generally showed a low to moderate correlation with EQ-5D visual analogue scale ( range 0.16-0 .43 ) and with the visual acuity score ( range 0.10-0 .41 ) .
RESULTS	Construct validity was upheld with higher VFQ-25 scores for patients who saw more letters according to the ETDRS .
RESULTS	Almost all scales were shown to be responsive with Guyatt 's statistic ranging from 0.10 to 0.56 at 54 weeks .
CONCLUSIONS	The VFQ-25 has evidence to support its validity and reliability for measuring HRQoL in DME .
CONCLUSIONS	However , some operating characteristics of the instrument need further consideration and discussion in the case of DME patients .
CONCLUSIONS	Further research is therefore warranted in this indication .

###24652604
BACKGROUND	Hangeshashinto ( TJ-14 , a Kampo medicine ) , which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity , alleviates chemotherapy-induced oral mucositis ( COM ) .
BACKGROUND	We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer .
METHODS	We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis ( CTCAE v4 .0 grade 1 ) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial .
METHODS	The patients received a placebo or TJ-14 for 2-6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy .
METHODS	The primary end point was the incidence of grade 2 oral mucositis in the protocol treatment course , and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events .
RESULTS	Following the key opening of the blinding protocol , we analyzed 91 eligible patients ( TJ-14 : 45 , placebo : 46 ) using a `` per protocol set '' analysis .
RESULTS	The incidence of grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group ( p = 0.588 ) .
RESULTS	The median duration of grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group ( p = 0.894 ) .
RESULTS	Meanwhile , the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [ hazard ratio 0.60 ; 95 % CI ( 0.23-1 .59 ) , p = 0.290 ] .
CONCLUSIONS	Although TJ-14 treatment did not reduce the incidence of 2 COM in the patients who developed mucositis during chemotherapy for gastric cancer , a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle .
CONCLUSIONS	Further , phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM .

###15066066
OBJECTIVE	To establish the effectiveness of a fall-prevention program in reducing falls and injurious falls in older residential care residents .
METHODS	Cluster , randomized , controlled trial .
METHODS	Fourteen randomly selected residential care homes in Auckland , New Zealand .
METHODS	All older residents ( n = 628 , 95 % participation rate ) .
METHODS	Residential care staff , using existing resources , implemented systematic individualized fall-risk management for all residents using a fall-risk assessment tool , high-risk logo , and strategies to address identified risks .
METHODS	Number of residents sustaining a fall , falls , and injurious-falls incidence rates .
RESULTS	During 12 months of follow-up , 103 ( 43 % ) residents in the control group and 173 ( 56 % ) residents in the intervention group fell ( P < .018 ) .
RESULTS	There was a significantly higher incidence rate of falls in intervention homes than in control homes ( incident rate ratio = 1.34 , 95 % confidence interval = 1.06-1 .72 ) during the intervention period after adjusting for dependency level ( type of home ) , baseline fall rate , and clustering .
RESULTS	There was no difference in the injurious fall incidence rate or incidence of serious injuries .
CONCLUSIONS	This fall-prevention intervention did not reduce falls or injury from falls .
CONCLUSIONS	Low-intensity intervention may be worse than usual care .

###10023367
BACKGROUND	Improved clinic based syndromic management of sexually transmitted diseases ( STDs ) in Tanzania reduced HIV transmission .
BACKGROUND	However , in many developing countries , people seek STD treatment in pharmacies .
BACKGROUND	This study used standardised simulated patients ( SSP ) to assess STD syndromic management in pharmacies and evaluate the impact of an educational intervention .
METHODS	SSP presented syndromes of urethral discharge , genital ulcer , vaginal discharge , and pelvic inflammatory disease ( PID ) at 180 randomly selected pharmacies in Lima , Peru .
METHODS	These pharmacies were then randomised to receive or not receive education on STD recognition , management , and prevention counselling , and were again visited by SSP .
RESULTS	At 360 pharmacy visits before the intervention , syndromes most often recognised as STD related were genital ulcer ( 81 % ) and urethral discharge ( 73 % ) in men , followed by vaginal discharge ( 43 % ) and PID ( 6 % ) in women .
RESULTS	Treatments offered to 82.5 % of SSP rarely conformed to international or national guidelines ( for urethral discharge , 1.5 % ; genital ulcer , 1 % ; vaginal discharge , 4 % ; and PID , none ) .
RESULTS	Only 20.5 % of SSP were referred to a physician and 30 % received any counselling .
RESULTS	The intervention reached 55 % of pharmacies , and produced a small but significant increase in counselling ; by `` intent to intervene '' analysis , intervention pharmacies provided post-counselling more often than did controls ( 40 % v 27 % , p = 0.01 ) .
CONCLUSIONS	Pharmacies usually failed to recognise STD syndromes in women , and usually provided treatment , most often with ineffective regimens .
CONCLUSIONS	Educational interventions improved counselling .
CONCLUSIONS	More effective interventions are needed to improve STD recognition , treatment , and referral practices .

###23771807
OBJECTIVE	This study aimed to determine whether there is a relationship between iron status and bone metabolism , and to compare the effects of the consumption , as part of the usual diet , of an iron or iron and vitamin D-fortified skimmed milk on bone remodelling in iron-deficient women .
METHODS	Young healthy iron-deficient or iron-sufficient women ( serum ferritin 30 ng/mL or > 30 ng/mL , respectively ) were recruited .
METHODS	Iron-deficient women were assigned to a nutritional intervention consisting of a randomised , controlled , double-blind , parallel design trial of 16 weeks during winter .
METHODS	They consumed , as part of their usual diet , an iron ( Fe group , n = 54 ) or iron and vitamin D-fortified ( Fe + D group , n = 55 ) flavoured skimmed milk ( iron , 15 mg/day ; vitamin D3 , 5 g/day , 200 IU ) .
METHODS	The iron-sufficient women followed their usual diet without supplementation ( R group , n = 56 ) .
METHODS	Dietary intake , body weight , iron biomarkers , 25-hydroxyvitamin D ( 25OHD ) , parathyroid hormone ( PTH ) , procollagen-type 1 N-terminal propeptide ( P1NP ) , and aminoterminal telopeptide of collagen I ( NTx ) were determined .
RESULTS	Negative correlations were found between baseline log-ferritin and log-NTx ( p < 0.001 ) , and between transferrin and P1NP ( p = 0.002 ) .
RESULTS	Serum 25OHD increased ( from 62 21 to 71 21 nmol/L , mean SD , p < 0.001 ) while P1NP and NTx decreased in Fe + D during the assay ( p = 0.004 and p < 0.001 , respectively ) .
RESULTS	NTx was lower in Fe + D compared to Fe at week 8 ( p < 0.05 ) and was higher in Fe and Fe + D compared to R throughout the assay ( p < 0.01 ) .
RESULTS	PTH did not show changes .
CONCLUSIONS	Iron deficiency is related with higher bone resorption in young women .
CONCLUSIONS	Consumption of a dairy product that supplies 5 g/day of vitamin D3 reduces bone turnover and increases circulating 25OHD to nearly reach an optimal vitamin D status , defined as 25OHD over 75 nmol/L .

###17717446
OBJECTIVE	Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy .
OBJECTIVE	External drainage of pancreatic duct with a stent has been shown to reduce pancreatic fistula rate of pancreaticojejunostomy in a few retrospective or prospective nonrandomized studies , but no randomized controlled trial has been reported thus far .
OBJECTIVE	This single-center prospective randomized trial compared the results of pancreaticoduodenectomy with external drainage stent versus no stent for pancreaticojejunal anastomosis .
METHODS	A total of 120 patients undergoing pancreaticoduodenectomy with end-to-side pancreaticojejunal anastomosis were randomized to have either an external stent inserted across the anastomosis to drain the pancreatic duct ( n = 60 ) or no stent ( n = 60 ) .
METHODS	Duct-to-mucosa anastomosis was performed in all cases .
RESULTS	The 2 groups were comparable in demographic data , underlying pathologies , pancreatic consistency , and duct diameter .
RESULTS	Stented group had a significantly lower pancreatic fistula rate compared with nonstented group ( 6.7 % vs. 20 % , P = 0.032 ) .
RESULTS	Radiologic or surgical intervention for pancreatic fistula was required in 1 patient in the stented group and 4 patients in the nonstented group .
RESULTS	There were no significant differences in overall morbidity ( 31.7 % vs. 38.3 % , P = 0.444 ) and hospital mortality ( 1.7 % vs. 5 % , P = 0.309 ) .
RESULTS	Two patients in the nonstented group and none in the stented group died of pancreatic fistula .
RESULTS	Hospital stay was significantly shorter in the stented group ( mean 17 vs. 23 days , P = 0.039 ) .
RESULTS	On multivariate analysis , no stenting and pancreatic duct diameter < 3 mm were significant risk factors of pancreatic fistula .
CONCLUSIONS	External drainage of pancreatic duct with a stent reduced leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy .

###22001100
OBJECTIVE	To determine the efficacy and safety of high-power holmium : yttrium aluminum-garnet ( Ho : YAG ) laser lithotripsy for multitract modified minimally invasive percutaneous nephrolithotomy ( MPCNL ) in the treatment of patients with large staghorn renal calculi .
METHODS	A randomized , prospective study was conducted .
METHODS	Two-hundred seventy-three consecutive patients ( 291 renal units ) with large staghorn renal calculi were randomized to undergo multitract MPCNL with 30-W low-power or 70-W high-power Ho : YAG laser lithotripsy .
METHODS	Both groups were compared in terms of perioperative findings and postoperative outcomes , including procedure time , stone-free rate , length of hospital stay , transfusion rates , renal function recovery , and other complications .
RESULTS	The average patient age was 49.2 years ( range 22-73 ) and mean stone size was 5.540.7 cm .
RESULTS	The 2 groups had some comparable perioperative findings and outcome , including tracts required per operated renal unit ( n ) , blood loss , postoperative fever , postoperative hospital stay , stone-free rate , and improvement of operated renal function .
RESULTS	The operation time in the high-power group was significantly shorter than that in the low-power group ( 129.2017.2 vs 105.1814.2 , P < .01 ) .
CONCLUSIONS	A combination of multitract MPCNL and high-power Ho : YAG laser lithotripsy can greatly decrease the operative time without increasing the intraoperative complications or delaying postoperative renal function recovery when compared with low-power Ho : YAG laser lithotripsy .

###19013751
OBJECTIVE	Decrease acute pain after breast cancer surgery by an infiltration of ropivacaine .
OBJECTIVE	Analyse effect on chronic pain .
METHODS	Prospective randomised double blind versus placebo study .
METHODS	Eighty-one patients randomised between two groups received wound infiltration with 40 ml of ropivacaine 4.75 mg/ml or placebo .
METHODS	Acute pain was assessed during 24h with analogical visual scale and antalgic consumption .
METHODS	One year later , telephonic interviews looked for chronic pain and evaluate it with McGill Pain Questionnaire .
RESULTS	Analogical visual scale pain score , antalgic consumption and chronic pain incidence were similar between groups .
CONCLUSIONS	Ropivacaine scar infiltration provided no acute or chronic pain relief after breast cancer surgery .

###16698524
OBJECTIVE	To compare pain management of standard analgesic and standard analgesic plus diclofenac transdermal patch in patients who undergo laparoscopic gynecologic surgery .
METHODS	Randomized prospective study ( Canadian Task Force classification I ) .
METHODS	University hospital .
METHODS	One hundred twenty patients requiring laparoscopic surgery for gynecologic benign diseases .
METHODS	Patients were divided into two groups , one medicated with a diclofenac patch ( diclofenac group ) and the other medicated with standard skin medication ( placebo ; control group ) at all incisional areas at the end of the operation .
RESULTS	The principal measures of outcome were pain intensity at 6 , 12 , and 24 hours after surgery and consumption of analgesics .
RESULTS	The two treatment groups were comparable with respect to demographic and intraoperative characteristics .
RESULTS	No significant difference was observed between the two groups in mean pain intensity at 6 hours after surgery .
RESULTS	Mean pain intensity at 12 and 24 hours , respectively , after surgery was significantly lower in the diclofenac group ( 3.7 + / - 1.3 and 2.0 + / - 0.6 ) than that observed in the control group ( 5.7 + / - 1.9 and 4.6 + / - 0.5 ) ( p value , respectively , .002 and < .001 ) .
RESULTS	Twenty-one patients ( 35.0 % ) in the diclofenac group required analgesics in the first 36 hours after the operation versus 43 patients ( 71.7 % ) in the control group ( p < .001 ) .
RESULTS	Hospital discharge was significantly more rapid in the diclofenac group ( 28 + / - 5 hours vs 39 + / - 3 hours ; p = .031 ) .
CONCLUSIONS	Diclofenac transdermal administration seems a valid help to standard analgesic treatment in postoperative pain control and could also help reduce the period of hospitalization of patients who undergo laparoscopic benign gynecologic surgery .

###24014477
OBJECTIVE	This randomized prospective study examines durability of improvement in general symptomatology , psychosocial functioning and interpersonal problems , and compares the long-term efficacy of analytic and systemic group psychotherapy in women 1 year after completion of treatment for childhood sexual abuse .
METHODS	Women ( n = 106 ) randomly assigned to analytic or systemic psychotherapy completed the Symptom Checklist-90-R , Global Assessment of Functioning , Global Life Quality , Registration Chart Questionnaire , and Flashback Registration at pre-treatment , post-treatment , and at a 1-year follow-up .
RESULTS	Post-treatment gains were significant for both treatment modalities on all measures , but significantly larger after systemic therapy .
RESULTS	Significant treatment response was maintained 1-year post-treatment , but different trajectories were observed : 1 year after treatment completion , improvements for analytic therapy were maintained , whereas they decreased after systemic therapy , resulting in no statistically significant difference in gains between the groups at the 1-year follow-up .
RESULTS	Despite maintaining significant gains , more than half of the patients remained above cut-off for caseness concerning general symptomatology at post-treatment and at 1-year follow-up .
CONCLUSIONS	The findings stress the importance of long-term follow-up data in effect studies .
CONCLUSIONS	Different trajectories were associated with the two treatments , but improvement in the two treatment groups did not differ significantly at the 1-year follow-up .
CONCLUSIONS	Implications of the difference in trajectories for treatment planning are discussed .
CONCLUSIONS	Both analytic and systemic group therapy proved efficient in improving general symptomatology , psychosocial functioning , and interpersonal problems in women with a history of CSA and gains were maintained at a 1-year follow-up .
CONCLUSIONS	Despite maintaining statistically significant gains at the 1-year follow-up , 54 % of the patients remained above the cut-off for caseness with respect to general symptomatology , which may indicate a need for further treatment .
CONCLUSIONS	Different pre-post follow-up treatment trajectories were observed between the two treatment modalities .
CONCLUSIONS	Thus , while systemic group therapy showed a significantly better outcome immediately after termination , gains in the systemic treatment group decreased during follow-up , while gains were maintained during follow-up in analytic group therapy .

###24126070
BACKGROUND	Patient decision delay is the main reason why many patients fail to receive timely medical intervention for symptoms of acute coronary syndrome ( ACS ) .
OBJECTIVE	This study examines the validity of slow-onset and fast-onset ACS presentations and their influence on ACS prehospital delay times .
OBJECTIVE	A fast-onset ACS presentation is characterized by sudden , continuous , and severe chest pain , and slow-onset ACS pertains to all other ACS presentations .
METHODS	Baseline data pertaining to medical profiles , prehospital delay times , and ACS symptoms were recorded for all ACS patients who participated in a large multisite randomized control trial ( RCT ) in Dublin , Ireland .
METHODS	Patients were interviewed 2-4 days after their ACS event , and data were gathered using the ACS Response to Symptom Index .
RESULTS	Only baseline data from the RCT , N = 893 patients , were analyzed .
RESULTS	A total of 65 % ( n = 577 ) of patients experienced slow-onset ACS presentation , whereas 35 % ( n = 316 ) experienced fast-onset ACS .
RESULTS	Patients who experienced slow-onset ACS were significantly more likely to have longer prehospital delays than patients with fast-onset ACS ( 3.5 h vs. 2.0 h , respectively , t = -5.63 , df 890 , p < 0.001 ) .
RESULTS	A multivariate analysis of delay revealed that , in the presence of other known delay factors , the only independent predictors of delay were slow-onset and fast-onset ACS ( = -.096 , p < 0.002 ) and other factors associated with patient behavior .
CONCLUSIONS	Slow-onset ACS and fast-onset ACS presentations are associated with distinct behavioral patterns that significantly influence prehospital time frames .
CONCLUSIONS	As such , slow-onset ACS and fast-onset ACS are legitimate ACS presentation phenomena that should be seriously considered when examining the factors associated with prehospital delay .

###25856121
BACKGROUND	FVC outcomes in clinical trials on idiopathic pulmonary fibrosis ( IPF ) can be substantially influenced by the analytic methodology and the handling of missing data .
BACKGROUND	We conducted a series of sensitivity analyses to assess the robustness of the statistical finding and the stability of the estimate of the magnitude of treatment effect on the primary end point of FVC change in a phase 3 trial evaluating pirfenidone in adults with IPF .
METHODS	Source data included all 555 study participants randomized to treatment with pirfenidone or placebo in the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis ( ASCEND ) study .
METHODS	Sensitivity analyses were conducted to assess whether alternative statistical tests and methods for handling missing data influenced the observed magnitude of treatment effect on the primary end point of change from baseline to week 52 in FVC .
RESULTS	The distribution of FVC change at week 52 was systematically different between the two treatment groups and favored pirfenidone in each analysis .
RESULTS	The method used to impute missing data due to death had a marked effect on the magnitude of change in FVC in both treatment groups ; however , the magnitude of treatment benefit was generally consistent on a relative basis , with an approximate 50 % reduction in FVC decline observed in the pirfenidone group in each analysis .
CONCLUSIONS	Our results confirm the robustness of the statistical finding on the primary end point of change in FVC in the ASCEND trial and corroborate the estimated magnitude of the pirfenidone treatment effect in patients with IPF .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01366209 ; URL : www.clinicaltrials.gov .

###22360152
BACKGROUND	Superficial thrombophlebitis can produce pain and result in a deep vein thrombosis ( DVT ) if not treated .
BACKGROUND	Conservative therapies including prescription of non-steroidal anti-inflammatory drugs ( NSAID ) and heat have been standard care .
BACKGROUND	Recently , studies have been published reporting efficacy and safety of low-molecular-weight heparin for the treatment of superficial thrombophlebitis .
BACKGROUND	However , there are few comparative trials to conservative therapy .
BACKGROUND	We studied the effectiveness and safety of treatment with dalteparin compared with ibuprofen in patients with confirmed superficial thrombophlebitis .
METHODS	Consecutive patients were randomized to receive daily dalteparin vs. ibuprofen three times daily for up to 14 days .
METHODS	The primary outcome measure was the incidence of extension of thrombus or new symptomatic venous thromboembolism during the 14-day and 3-month follow-up period .
METHODS	The secondary outcome was a reduction in pain .
METHODS	The outcome measure of safety was the incidence of major and minor bleeding .
RESULTS	Of 302 consecutive patients screened , 72 were enrolled .
RESULTS	Four patients receiving ibuprofen compared with no patients receiving dalteparin had thrombus extension at 14 days ( P = 0.05 ) , however , there was no difference in thrombus extension at 3 months .
RESULTS	Both treatments significantly reduced pain .
RESULTS	There were no episodes of major or minor bleeding during the treatment period .
CONCLUSIONS	Dalteparin is superior to the NSAID ibuprofen in preventing extension of superficial thrombophlebitis during the 14-day treatment period with similar relief of pain and no increase in bleeding .
CONCLUSIONS	However , questions concerning the optimal treatment duration should be explored in future trials .

###23153395
BACKGROUND	Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4 .
BACKGROUND	Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions , but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture , health system and policy environment is different .
BACKGROUND	In Uganda , health outcomes are poor for both mothers and newborn babies .
BACKGROUND	Policy opportunities for neonatal health include the new national Health Sector Strategic Plan , which now prioritizes newborn health including use of a community model through Village Health Teams ( VHT ) .
BACKGROUND	The aim of the present study is to adapt , develop and cost an integrated maternal-newborn care package that links community and facility care , and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda .
METHODS	Through formative research around evidence-based practices , and dialogue with policy and technical advisers , we constructed a home-based neonatal care package implemented by the responsible VHT member , effectively a Community Health Worker ( CHW ) .
METHODS	This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered .
METHODS	The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas.The study is taking place in a new Demographic Surveillance Site in two rural districts , Iganga and Mayuge , in Uganda .
METHODS	It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas ( villages ) .
METHODS	The comparison parishes receive the standard care already being provided by the district , but to the intervention villages are added a system for CHWs to visit the mother five times in her home during pregnancy and the neonatal period .
METHODS	Both areas benefit from a standardized strengthening of facility care for mothers and neonates .
CONCLUSIONS	UNEST is designed to directly feed into the operationalization of maternal and newborn care in the national VHT strategy , thereby helping to inform scale-up in rural Uganda .
CONCLUSIONS	The study is registered as a randomized controlled trial , number ISRCTN50321130 .

###12923131
BACKGROUND	Medical treatment of ectopic pregnancies is common .
BACKGROUND	To increase the efficacy of methotrexate , the association of mifepristone has been proposed .
METHODS	We performed a large prospective multicentre double-blind sequential randomized trial in order to compare the efficacy of methotrexate and mifepristone ( 600 mg given orally ) versus methotrexate and placebo .
RESULTS	A total of 212 ectopic pregnancies was randomized .
RESULTS	There was no significant difference in the initial characteristics between the two groups .
RESULTS	There was no significant difference in the success rate of medical treatment between the methotrexate-mifepristone ( n = 113 ) and the methotrexate-placebo group ( n = 99 ) : 79.6 % ( 90/113 ) versus 74.2 % ( 72/97 ) respectively , RR ( 95 % CI ) : 1.07 ( 0.92-1 .25 ) , P = 0.41 , non-significant .
RESULTS	However , there was a quantitative interaction between progesterone level and effect of treatment : when progesterone level was > / = 10 ng/l , the efficacy of the combination of mifepristone and methotrexate was significantly higher than the combination of methotrexate and placebo , with an 83.3 % success rate ( 15/18 ) versus 38.5 % ( 5/13 ) respectively .
CONCLUSIONS	Our study failed to demonstrate any benefit of the addition of mifepristone to methotrexate .
CONCLUSIONS	By contrast , the quantitative interaction between treatment effect and baseline serum progesterone suggested that this combination could be limited to ectopic pregnancies associated with high serum progesterone concentrations .

###11302998
OBJECTIVE	To characterise the central and regional haemodynamic effects of insulin in patients with chronic heart failure .
METHODS	Single blind , placebo controlled study .
METHODS	University teaching hospital .
METHODS	Ten patients with stable chronic heart failure .
METHODS	Hyperinsulinaemic euglycaemic clamp and non-invasive haemodynamic measurements .
METHODS	Change in resting heart rate , blood pressure , cardiac output , and regional splanchnic and skeletal muscle blood flow .
RESULTS	Insulin infusion led to a dose dependent increase in skeletal muscle blood flow of 0.36 ( 0.13 ) and 0.73 ( 0.14 ) ml/dl/min during low and high dose insulin infusions ( p < 0.05 and p < 0.005 v placebo , respectively ) .
RESULTS	Low and high dose insulin infusions led to a fall in heart rate of 4.6 ( 1.4 ) and 5.1 ( 1.3 ) beats/min ( p < 0.05 and p < 0.005 v placebo , respectively ) and a modest increase in cardiac output .
RESULTS	There was no significant change in superior mesenteric artery blood flow .
CONCLUSIONS	In patients with chronic heart failure insulin is a selective skeletal muscle vasodilator that leads to increased muscle perfusion primarily through redistribution of regional blood flow rather than by increased cardiac output .
CONCLUSIONS	These results provide a rational haemodynamic explanation for the apparent beneficial effects of insulin infusion in the setting of heart failure .

###20535638
OBJECTIVE	To compare the efficiency and spontaneous expulsion rates of tamsulosin and Rowatinex in patients with distal ureteral stones .
METHODS	Between March and July 2009 , 90 patients with distal ureteral stones < 10mm in size were included in the study .
METHODS	Patients were randomized in 3 groups : Group 1 ( n = 31 , those received 0.4 mg tamsulosin once daily ) , Group 2 ( n = 30 , those received 100mg Rowatinex capsules 3 times a day ) , and Group 3 ( n = 29 , those received diclofenac 100mg once daily ) .
METHODS	All patients were followed up for 10days .
CONCLUSIONS	Mean age of the patients was 42.416.1 ( range , 22-75 ) , 46.516.5 ( range , 22-76 ) , and 43.516.6 ( range , 18-71 ) years in Groups 1-3 , respectively .
CONCLUSIONS	On admission , 37.8 % had hematuria and 78.9 % had lower urinary tract symptoms ( LUTS ) .
CONCLUSIONS	No statistically significant differences were detected between the three groups regarding patient age , gender , mean stone size , stone location , stone site , additional analgesic requirement , number of ureteral colics during the treatment , and upper urinary tract dilation .
CONCLUSIONS	The mean stone expulsion time was 3.5 days in Group 1 , 6days in Group 2 , and 7days in Group 3 ( P = 0.02 ) .
CONCLUSIONS	Stone expulsion rate was significantly high in Group 1 compared to Group 2 ( P = 0.002 ) .
CONCLUSIONS	Similarly , stone expulsion rate was significantly high in Group 1 compared to Group 3 ( P = 0.001 ) .
CONCLUSIONS	Medical treatment with tamsulosin seems to be effective in patients with distal ureteral stones < 10mm in size .
CONCLUSIONS	However , use of Rowatinex does not seem to have any significant effect on clearance rate of distal ureteral calculi .

###19959271
OBJECTIVE	The aim of the present study was to examine the effect of intravenous midazolam and propofol sedation on autonomic nervous activities during psychological stress , and whether these results are associated with changes in subjective stress feelings .
METHODS	Seven healthy male volunteers were included in a randomized crossover manner .
METHODS	The heart rate ( HR ) , HR variability , arterial oxygen saturation , and bispectral index value were continuously monitored .
METHODS	A mental arithmetic task for 7 minutes was given with or without intravenous sedation with midazolam or propofol .
METHODS	A bispectral index value of 75 to 85 and an Observer 's Assessment of Alertness/Sedation score of 4 were the targeted sedation level in both groups .
METHODS	HR variability was assessed using the power spectral analysis ( low-frequency [ LF ] and high-frequency [ HF ] components and LF/HF ratio ) .
METHODS	The faces anxiety scale was used to grade their stress feelings after each mental arithmetic task .
RESULTS	During the mental arithmetic task with intravenous sedation , no differences were found in the bispectral index values , arterial oxygen saturation , or the results of the mental arithmetic task between the 2 groups .
RESULTS	The HR , LF/HF ratio , and normalized unit LF increased , and the normalized unit HF decreased in both groups .
RESULTS	However , the percentage of changes in LF/HF ratio , normalized unit LF , and normalized unit HF were smaller in the midazolam group .
RESULTS	In addition , the reduction in faces anxiety scale was greater in the midazolam group .
CONCLUSIONS	These results suggest that midazolam more effectively suppresses sympathetic nervous activation and reduces subjective stress feelings during a mental arithmetic task than propofol .

###9264765
OBJECTIVE	To compare two contact and non-contact techniques using the VLAP system ( visual laser ablation of the prostate ) .
METHODS	From January 1994 to April 1995 , two groups of 50 patients were included in a randomized prospective study and were treated by the contact and non-contact laser technique , respectively .
METHODS	These patients presented with symptomatic BPH requiring transurethral electroresection .
METHODS	These patients were evaluated according to subjective ( AUA score ) and objective criteria ( maximum flow rate , transrectal and suprapubic ultrasonography ) .
METHODS	ND : YAG laser energy was delivered by a Medilas 4100 source via a lateral beam fibre .
METHODS	Objective success criteria were an improvement of the AUA score by at least 50 % and of the maximum flow rate by at least 50 % with a difference of 4 mL/s .
METHODS	The failure criterion was the need to perform complementary electroresection during the first 6 postoperative months .
RESULTS	The mortality was 2 % ( cardiovascular causes ) , and the overall morbidity ( first postoperative month ) was 29 % , with 21 % of a vesical irritation syndrome , 6 % of urinary tract infection and 2 % of bladder clots .
RESULTS	The global result at 12 months showed a statistically significant postoperative improvement of the subjective and objective parameters studied preoperatively ( p = 0.0001 ) .
RESULTS	In the contact group , the AUA score , mean maximum flow rate and residual urine , which had preoperative values of 19.1 , 9.1 mL/s and 141 mL , respectively , were equal to 2.3 , 15.6 mL/s and 45 mL at 12 months .
RESULTS	In the non-contact group , the same parameters , which had preoperative values of 17.8 , 9.2 mL/s and 87 mL , respectively , were equal to 3.8 , 13.3 mL/s and 47 mL at 12 months .
RESULTS	The results , evaluated as a function of objective success criteria , showed a 12-month success rate of 68 % for the contact method and 61 % for the non-contact method .
RESULTS	The mean hospital stay was 6 days and the mean duration of bladder catheterization was 5 days with the two techniques .
RESULTS	During follow-up , 7 % of patients required revision by electroresection , regardless of the technique used .
CONCLUSIONS	this study demonstrated identical results for the contact and non-contact techniques using the VLAP system .

###20833940
BACKGROUND	Delirium is a serious postoperative condition for which few pharmacologic prevention trials have been conducted .
OBJECTIVE	The authors tested the efficacy of perioperative olanzapine administration to prevent postoperative delirium in elderly patients after joint-replacement surgery .
METHODS	The authors conducted a randomized , double-blind , placebo-controlled , prophylaxis trial at an orthopedic teaching hospital , enrolling 495 elderly patients age 65 years , who were undergoing elective knee - or hip-replacement surgery ; 400 patients received either 5 mg of orally-disintegrating olanzapine or placebo just before and after surgery .
METHODS	The primary efficacy outcome was the incidence of ( DSM-III-R ) delirium .
RESULTS	The incidence of delirium was significantly lower in the olanzapine group than in the placebo group ; this held true for both knee - and hip-replacement surgery .
RESULTS	However , delirium lasted longer and was more severe in the olanzapine group .
RESULTS	Advanced age , a high level of medical comorbidity , an abnormal albumin level , and having knee-replacement surgery were independent risk factors for postoperative delirium ( Clinicaltrials.gov Identifier : NCT000699946 ) .
CONCLUSIONS	Administration of 10 mg of oral olanzapine perioperatively , versus placebo , was associated with a significantly lower incidence of delirium .
CONCLUSIONS	These findings suggest that olanzapine prophylaxis of postoperative delirium may be an effective strategy .

###23683134
OBJECTIVE	Assess influences of demographics and co-morbidities of gout patients with or without diabetes on safety and efficacy of urate-lowering agents .
METHODS	Post-hoc analysis of 312 diabetic and 1957 non-diabetic gout patients [ baseline serum urate levels ( sUA ) 8.0 mg/dl ] enrolled in a 6-month randomized controlled trial comparing urate-lowering efficacy ( ULE ) and safety of daily xanthine oxidase inhibitors ( XOIs ) febuxostat ( 40mg or 80mg ) and allopurinol ( 200mg or 300mg ) .
METHODS	We compared baseline demographic , gout and co-morbid characteristics , ULE , and safety of XOI treatment in diabetic and non-diabetic gout patients .
METHODS	ULE was measured by the proportion of diabetic and non-diabetic patients in each treatment group achieving final visit sUA < 6.0 mg/dl .
METHODS	Safety was monitored throughout the trial .
RESULTS	Diabetic gout patients were older , more frequently female , and had longer gout duration .
RESULTS	Co-morbidities were more frequent among diabetic patients : cardiovascular disease ; impaired renal function ; hyperlipidemia ; and obesity ( body mass index > 30kg/m ) ( p < 0.001 for all comparisons ) .
RESULTS	Febuxostat 80mg ULE exceeded that of febuxostat 40mg or allopurinol ( p < 0.050 ) at all levels of renal function , achieving sUA goal range in the majority of diabetic and non-diabetic patients .
RESULTS	Diabetics and non-diabetics reported self-limiting diarrhoea and URIs as the most common adverse events .
CONCLUSIONS	Despite higher co-morbidity rates in diabetic patients , febuxostat and allopurinol were safe in both groups at the doses tested .
CONCLUSIONS	Febuxostat 80mg achieved sUA < 6.0 mg/dl more often than febuxostat 40mg or allopurinol at commonly prescribed doses .

###23550906
OBJECTIVE	Ulipristal acetate ( UPA ) is a novel selective progesterone receptor modulator for benign gynaecological conditions such as uterine myoma .
OBJECTIVE	The safety and pharmacokinetics of multiple-dose UPA and its N-mono-demethylated metabolite , PGL4002 , were investigated in women .
METHODS	The double-blind , placebo-controlled study randomized 32 healthy women of reproductive age to receive 10 consecutive daily doses of placebo , 10 , 20 or 50mg UPA .
METHODS	Safety assessments included vital signs , physical examination , ECG , clinical laboratory tests and reporting of adverse events .
METHODS	Blood samples for pharmacokinetic analysis were collected on Days 1 and 10 at intervals until 168h after multiple dosing .
RESULTS	UPA was well tolerated at all doses .
RESULTS	Mild or moderate adverse events occurred with similar frequency in UPA and placebo groups .
RESULTS	UPA median tmax was 075 and 089h , and mean plasma half-life was between 38 and 49h .
RESULTS	Cmax values ( Day 1 ) were 422 , 1309 and 3548ng/mL for the UPA 10 , 20 and 50mg treatment groups , respectively .
RESULTS	Corresponding Cmax values for Day 10 were 637 , 1698 and 4549ng/mL .
RESULTS	AUCSS values on Day 10 were 2166 , 6028 and 16557ngh/mL after 10 , 20 and 50mg UPA , respectively .
RESULTS	For the principal metabolite PGL4002 , tmax and plasma elimination half-life values were similar to those of UPA .
RESULTS	PGL4002 AUCSS Day 10 values were 847 , 2036 and 4521ngh/mL for 10 , 20 and 50mg groups , respectively .
CONCLUSIONS	Daily administration of UPA at therapeutic and supratherapeutic doses was well tolerated by women of reproductive age .
CONCLUSIONS	UPA exposure increases with dose .
CONCLUSIONS	Exposure to PGL4002 is approximately one-third that of UPA .

###21989186
BACKGROUND	Panitumumab in combination with chemotherapy was evaluated in two pivotal clinical trials in first - and second-line treatment of metastatic colorectal cancer ( mCRC ) , respectively .
BACKGROUND	This analysis compared the health-related quality of life ( HRQoL ) of patients with or without panitumumab in the two trials .
METHODS	Patients with mCRC were randomised to FOLFOX ( first-line trial ) or FOLFIRI ( second-line trial ) panitumumab .
METHODS	The EuroQoL 5-Dimensions Health State Index ( EQ-5D HSI ) and Visual Analogue Scale ( EQ-5D VAS ) were assessed at baseline and monthly follow-up until disease progression .
METHODS	Patients with wild-type KRAS mCRC with baseline and post-baseline HRQoL scores were included .
METHODS	Difference in change from baseline between treatment groups was evaluated using linear mixed and pattern-mixture models .
RESULTS	In the first-line trial , 576 patients with wild-type KRAS mCRC ( 284 panitumumab + FOLFOX4 and 292 FOLFOX4 alone ) were included in the HRQoL analyses .
RESULTS	In the second-line trial , 530 patients with wild-type KRAS mCRC were included in these analyses ( 263 panitumumab + FOLFIRI and 267 FOLFIRI alone ) .
RESULTS	There was no significant difference in the change in EQ-5D HSI and VAS scores between treatment groups in either trial .
CONCLUSIONS	The addition of panitumumab to FOLFOX4 or FOLFIRI in first - or second-line treatment of wild-type KRAS mCRC significantly improved progression-free survival without compromising HRQoL .

###9117505
OBJECTIVE	This report details an extension of the use of psychoeducational workshops with psychiatric patients and their families to families of elderly patients with recurrent unipolar late-life depression .
METHODS	Subjects were 132 participants in a study of maintenance therapies for late-life depression and their 182 family members and significant others who accepted invitations to single-session family workshops .
METHODS	Participants provided feedback on their satisfaction with the content and quality of the workshops .
METHODS	Associations between workshop attendance , preworkshop demographic and clinical characteristics , treatment adherence , and outcome were explored through comparisons between 108 patients who attended workshops and 24 patients who declined the workshop invitation .
RESULTS	Favorable feedback from participants suggested that the extension of the workshops to families of elderly patients with depression was successful .
RESULTS	Workshop attendance was associated with a lower rate of dropout during continuation treatment .
CONCLUSIONS	Results associating workshop refusal and treatment dropout , as well as the overall treatment compliance and retention rates in this randomized clinical trial involving geriatric patients , support the need for further study of factors relating to elderly patients ' willingness to engage in family-centered interventions .

###15165408
OBJECTIVE	To assess individual difference characteristics of subgroups of patients with fibromyalgia ( FM ) patients with respect to the decision to stay in or switch from randomly-assigned verum or placebo treatment during an optional crossover phase of a double-blinded homeopathy study .
METHODS	Double-blinded , randomized , placebo-controlled , optional crossover clinical trial .
METHODS	Fifty-three ( 53 ) community-recruited patients with FM entered the optional crossover phase .
METHODS	Two homeopaths jointly selected an individualized homeopathic remedy for all patients .
METHODS	The pharmacy dispensed either verum LM remedy or indistinguishable placebo in accord with randomized assignment for 4 months and the patient 's optional crossover decision for an additional 2 months .
METHODS	Patients completed a battery of baseline state/trait questionnaires , including mood , childhood neglect and abuse , and trait absorption .
METHODS	They rated global health ( whole person-centered ) and tender point pain on physical examination ( disease-specific ) at baseline , 3 months , and 6 months .
RESULTS	Rates of optional crossover from verum to placebo or placebo to verum were comparable ( p = 0.6 ; 31 % , and 41 % , respectively ) .
RESULTS	The switch subgroups had greater baseline psychologic issues ( emotional neglect in placebo-switch ; depression and anger in verum-switch ) .
RESULTS	The verum-stay subgroup scored highest on treatment helpfulness and included all six exceptional responders who fell , prior to crossover , into the top terciles for improvement in both global health and pain .
RESULTS	Patients staying in their randomly assigned groups , active or placebo ( n = 34 ) , scored significantly higher in trait absorption than did those who switched groups ( n = 19 ) .
CONCLUSIONS	Individual difference factors may predict better and poorer responders with FM to specific and nonspecific effects of homeopathic and placebo treatment .

###22958441
BACKGROUND	This paper presents results from an evaluation of the effect of a community health worker ( CHW ) - based , interpersonal communication campaign ( IPC ) for increasing insecticide-treated mosquito net ( ITN ) use among children in Luangwa District , Zambia , an area with near universal coverage of ITNs and moderate to low malaria parasite prevalence .
METHODS	A quasi-experimental community randomized control trial was conducted from 2008 to 2010 .
METHODS	CHWs were the unit of randomization .
METHODS	Cross-sectional data were collected from houses in both 2008 and 2010 using simple random sampling of a complete household enumeration of the district .
METHODS	A difference-in - differences approach was used to analyse the data .
RESULTS	ITN use among children < 5years old in households with 1 ITN increased overall from 54 % in 2008 to 81 % in 2010 ( ( 2 ) = 96.3 , p < 0.01 ) ; however , there was no difference in increase between the treatment and control arms in 2010 ( p > 0.05 ) .
RESULTS	ITN use also increased among children five to 14years old from 37 % in 2008 to 68 % in 2010 .
RESULTS	There was no indication that the CHW-based intervention activities had a significant effect on increasing ITN use in this context , over and above what is already being done to disseminate information on the importance of using an ITN to prevent malaria infection .
CONCLUSIONS	ITN use increased dramatically in the district between 2008 and 2010 .
CONCLUSIONS	It is likely that IPC activities in general may have contributed to the observed increase in ITN use , as the increased observed in this study was far higher than the increase observed between 2008 and 2010 malaria indicator survey ( MIS ) estimates .
CONCLUSIONS	Contamination across control communities , coupled with linear settlement patterns and subsequent behavioural norms related to communication in the area , likely contributed to the observed increase in net use and null effect in this study .

###24190687
BACKGROUND	In developed societies levels of daily physical activity ( PA ) among school-age children are decreasing .
BACKGROUND	This implies risk factors for cardiovascular and metabolic diseases .
BACKGROUND	Specific strategies to improve levels of PA are needed .
BACKGROUND	In prepubertal boys there is evidence that strength training increases spontaneous PA outside of training .
METHODS	A total of 102 schoolchildren ( age 10-14 years ) in Switzerland were randomly assigned to physical education classes or to participate twice weekly at a guided strength training program for 19 weeks .
METHODS	Spontaneous PA energy expenditure ( PAEE ; 3axial accelerometry for 7 days ) , leg and arm strength , and body composition ( dual energy radiograph absorptiometry ) were measured at baseline , after 19 weeks of training intervention , and after 3 months of washout .
RESULTS	There were no significant differences between the groups at baseline .
RESULTS	In the intervention group , PAEE increased by 10 % from baseline to end of training in boys ( P = .02 ) , but not in girls .
RESULTS	Leg and arm strength were increased owing to training intervention in both boys and girls .
RESULTS	All other variables were unchanged .
RESULTS	Baseline PAEE was significantly negatively correlated with changes of PAEE .
CONCLUSIONS	Targeted strength training significantly increases daily spontaneous PA behavior in boys .
CONCLUSIONS	The less active children showed the greatest increase in spontaneous PAEE .
CONCLUSIONS	Girls showed a similar increase in strength , but not in spontaneous PAEE .
CONCLUSIONS	This may be explained by their earlier pubertal development .
CONCLUSIONS	Strength training may be a promising strategy in schools to counteract decreasing levels of PA. .

###10719857
OBJECTIVE	To conduct a placebo-controlled prospective study of the effectiveness of intrathecal bolus injections and continuous administration of baclofen on functional parameters in patients with severe spasticity of cerebral origin .
OBJECTIVE	To compare this functional evaluation with spasticity scores in different muscle groups .
METHODS	In 11 patients with spasticity of cerebral origin ( mainly cerebral palsy ) , double-blind scoring of spasticity ( Ashworth scale score and visual analog score ) , spasms , pain , and functional abilities was performed during tests with bolus injections including a placebo control .
METHODS	Eight patients were considered good responders and received a subcutaneous device for intrathecal drug delivery .
METHODS	Six of these patients were followed up for 2 years , during which they underwent the same scoring procedures as after their bolus injections .
METHODS	These patients were subjected to a blinded dose reduction test .
RESULTS	There was a noticeable placebo effect on spasticity scores during tests with bolus injections .
RESULTS	Eight patients demonstrated a significant beneficial effect of intrathecal bolus injections compared with this placebo effect .
RESULTS	Functional improvements were noted in most patients .
RESULTS	During continuous infusion , Ashworth scale scores were less favorable but still significantly lower than at baseline .
RESULTS	Subjective evaluation ( visual analog scores ) remained positive , functional improvements were maintained , and patient comfort was invariably and significantly improved .
CONCLUSIONS	Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin .
CONCLUSIONS	Functional improvement was demonstrated .
CONCLUSIONS	The presence of a placebo effect on the spasticity scores suggests the need for double-blind screening in each patient .

###17914032
OBJECTIVE	To determine mechanisms by which pioglitazone and metformin effect hepatic and extra-hepatic insulin action .
METHODS	Thirty-one subjects with type 2 diabetes were randomly assigned to pioglitazone ( 45 mg ) or metformin ( 2,000 mg ) for 4 months .
RESULTS	Glucose was clamped before and after therapy at approximately 5 mmol/l , insulin raised to approximately 180 pmol/l , C-peptide suppressed with somatostatin , glucagon replaced at approximately 75 pg/ml , and glycerol maintained at approximately 200 mmol/l to ensure comparable and equal portal concentrations on all occasions .
RESULTS	Insulin-induced stimulation of glucose disappearance did not differ before and after treatment with either pioglitazone ( 23 + / - 3 vs. 24 + / - 2 micromol x kg ( -1 ) x min ( -1 ) ) or metformin ( 22 + / - 2 vs. 24 + / - 3 micromol x kg ( -1 ) x min ( -1 ) ) .
RESULTS	In contrast , pioglitazone enhanced ( P < 0.01 ) insulin-induced suppression of both glucose production ( 6.0 + / - 1.0 vs. 0.2 + / - 1.6 micromol x kg ( -1 ) x min ( -1 ) ) and gluconeogenesis ( n = 11 ; 4.5 + / - 0.9 vs. 0.8 + / - 1.2 micromol x kg ( -1 ) x min ( -1 ) ) .
RESULTS	Metformin did not alter either suppression of glucose production ( 5.8 + / - 1.0 vs. 5.0 + / - 0.8 micromol x kg ( -1 ) x min ( -1 ) ) or gluconeogenesis ( n = 9 ; 3.7 + / - 0.8 vs. 2.6 + / - 0.7 micromol x kg ( -1 ) x min ( -1 ) ) .
RESULTS	Insulin-induced suppression of free fatty acids was greater ( P < 0.05 ) after treatment with pioglitazone ( 0.14 + / - 0.03 vs. 0.06 + / - 0.01 mmol/l ) but unchanged with metformin ( 0.12 + / - 0.03 vs. 0.15 + / - 0.07 mmol/l ) .
CONCLUSIONS	Thus , relative to metformin , pioglitazone improves hepatic insulin action in people with type 2 diabetes , partly by enhancing insulin-induced suppression of gluconeogenesis .
CONCLUSIONS	On the other hand , both drugs have comparable effects on insulin-induced stimulation of glucose uptake .

###15229417
BACKGROUND	Urgent endoscopy in patients with acute upper-GI bleeding identifies many patients who may be safely treated without hospitalization .
BACKGROUND	The aim of this multicenter trial was to determine whether urgent endoscopy effectively decreases health care resource utilization in a real-life setting where primary care providers determine the course of care .
METHODS	Ninety-three outpatients with acute upper-GI bleeding were randomized to either urgent endoscopy ( before hospitalization ) or elective endoscopy after admission .
METHODS	The results of urgent endoscopy and a recommendation regarding patient disposition were provided to the attending physician .
METHODS	Medical outcomes and resource utilization were measured .
RESULTS	The timing of endoscopy did not affect resource utilization or patient outcomes .
RESULTS	Length of stay was similar ( urgent endoscopy , OR 3.98 days : 95 % CI [ 2.84 , 5.11 ] vs. elective endoscopy , OR 3.26 days : 95 % CI [ 2.32 , 4.21 ] , p = 0.45 ) .
RESULTS	The mean number of days in an intensive care unit was the same ( 1.2 days ) .
RESULTS	The urgent endoscopy group had more high-risk endoscopic lesions ( 15 vs. 9 ; p = 0.031 ) .
RESULTS	Outpatient care was recommended for 19 patients ( 40 % ) .
RESULTS	Only 4 patients were discharged .
CONCLUSIONS	Urgent endoscopy did not reduce hospitalization or resource utilization because the results of early endoscopy did not impact the decision by attending physicians regarding admission .
CONCLUSIONS	For early ( triage ) endoscopy to impact resource utilization , the results of endoscopy must change subsequent patient care .

###21177789
BACKGROUND	Recombinant human GH ( rhGH ) replacement therapy in children and adults currently requires daily sc injections for several years or lifelong , which may be both inconvenient and distressing for patients .
BACKGROUND	NNC126-0083 is a pegylated rhGH developed for once-weekly administration .
OBJECTIVE	Our objective was to evaluate the safety , tolerability , pharmacokinetics , and pharmacodynamics of multiple doses of NNC126-0083 in adult patients with GH deficiency ( GHD ) .
METHODS	Thirty-three adult patients with GHD , age 20-65 yr , body mass index 18.5-35 .0 kg/m ( 2 ) , and glycated hemoglobin of 8.0 % or below .
METHODS	Fourteen days before randomization , subjects discontinued daily rhGH .
METHODS	NNC126-0083 ( 0.01 , 0.02 , 0.04 , and 0.08 mg/kg ) was given sc once weekly for 3 wk ( NNC126-0083 for six subjects and placebo for two subjects ) .
METHODS	Blood samples were collected up to 168 h after the first and up to 240 h after the third dosing .
METHODS	Physical examination , antibodies , and local tolerability were assessed .
RESULTS	NNC126-0083 was well tolerated with no difference in local tolerability compared with placebo and with no signs of lipoatrophy .
RESULTS	A more than dose-proportional exposure was observed at the highest NNC126-0083 dose ( 0.16 mg protein/kg ) .
RESULTS	Steady-state pharmacokinetics seemed achieved after the second dosing .
RESULTS	A clear dose-dependent pharmacodynamic response in circulating IGF-I levels was observed [ from a predose mean ( SD ) IGF-I SD score of -3.2 ( 1.7 ) to peak plasma concentration of -0.5 ( 1.3 ) , 1.6 ( 1.3 ) , 2.1 ( 0.5 ) , and 4.4 ( 0.9 ) in the four dose groups , respectively ] .
CONCLUSIONS	After multiple dosing of NNC126-0083 , a sustained pharmacodynamic response was observed .
CONCLUSIONS	NNC126-0083 has the potential to serve as an efficacious , safe , and well-tolerated once-weekly treatment of adult patients with GHD .

###23677137
OBJECTIVE	To compare the intensity of posterior capsule opacification ( PCO ) 3 years after implantation of 2 different 1-piece foldable hydrophobic acrylic intraocular lenses ( IOLs ) .
METHODS	Randomized , prospective , patient - and examiner-masked clinical trial with intraindividual comparison .
METHODS	One hundred patients with bilateral age-related cataract ( 200 eyes ) had standard cataract surgery with implantation of an iMics1 NY-60 IOL ( Hoya Corp ) in one eye and an AcrySof SN60WF IOL ( Alcon Laboratories ) in the other eye .
METHODS	Follow-up examinations were performed at 1 week and 3 years .
METHODS	Digital retroillumination images were obtained of each eye .
METHODS	The main outcome measure was PCO score ( scale , 0 to 10 ) assessed subjectively at the slit lamp and objectively using automated image analysis software ( Automated Quantification of After-Cataract ) 3 years after surgery .
RESULTS	The objective PCO score ( mean standard deviation ) was 3.0 2.0 for the iMics1 NY-60 IOL and 1.9 1.4 for the AcrySof SN60WF IOL ( P < .001 ) .
RESULTS	Three years after surgery , 35.6 % of patients underwent a neodymium : yttrium-aluminum-garnet capsulotomy in the iMics1 NY-60 eye and 13.7 % underwent a capsulotomy in the AcrySof SN60WF eye ( P = .001 ) .
RESULTS	There was no statistically significant difference in best-corrected visual acuity , rhexis-IOL overlap , capsular folds , or anterior capsule opacification .
RESULTS	Glistening formations were found in no iMics1 NY-60 IOLs , but in 97 % of the AcrySof SN60WF IOLs .
CONCLUSIONS	Comparison of 2 sharp-edged single-piece IOLs of similar design and hydrophobic acrylic material indicated a statistically significant difference in PCO and neodymium : yttrium-aluminum-garnet capsulotomy rate 3 years after surgery .

###23262383
OBJECTIVE	To compare the effects of a vapocoolant spray and an eutectic mixture of local anesthetics ( EMLA ) cream in reducing pain during needle electromyography examination .
METHODS	Randomized controlled trial .
METHODS	Physical medicine and rehabilitation department of a university hospital .
METHODS	Adults who underwent needle electromyography ( N = 99 ) were randomized to 1 of 2 experimental groups or the control group .
METHODS	Two patients dropped out during the study .
METHODS	In the experimental groups , vapocoolant spray or EMLA cream were applied before needle electromyography .
METHODS	In the control group , needle electromyography was performed without pretreatment .
METHODS	Intensity of pain associated with needle electromyography was assessed using a 100-mm visual analog scale ( VAS ) .
METHODS	Patient satisfaction and preference for repeated use were measured using a 5-point Likert scale .
RESULTS	VAS score for pain intensity was significantly lower in the spray group ( 31.9 ; 95 % confidence interval [ CI ] , 22.0-41 .7 ) compared with the control group ( 52.9 ; 95 % CI , 45.9-60 .0 ; P = .002 ) , whereas there was no significant difference between the EMLA cream group ( 42.4 ; 95 % CI , 34.2-50 .7 ) and the control group .
RESULTS	Patient satisfaction and preference for repeated use were higher in the spray group than the EMLA group .
CONCLUSIONS	Vapocoolant spray was more effective than EMLA cream in reducing pain during needle electromyography .

###9680899
OBJECTIVE	A double-blind , randomized , 6-month clinical trial with parallel group design in 162 patients with gingivitis divided into three rinsing groups was conducted in order to study the efficacy and safety of a flavoured solution of delmopinol hydrochloride 2 mg ml-1 ( 0.2 % w/v , Decapinol Mouthwash ) used for supervised mouthrinsing in one rinsing group , in comparison with chlorhexidine digluconate 2 mg ml-1 ( 0.2 % w/v , Hibitane Dental ) in a second rinsing group , and placebo in the third group .
OBJECTIVE	The criteria of the Plaque Index ( PI ) were used to assess plaque formation .
OBJECTIVE	Bleeding on probing ( BOP ) to the bottom of the pocket with a standard pressure was used as the primary gingivitis assessment .
OBJECTIVE	The occurrence of supragingival dental calculus and extrinsic tooth staining were also assessed .
OBJECTIVE	In addition , patients were asked to report adverse events at each visit .
RESULTS	Delmopinol and chlorhexidine exhibited lower scores of the mean PI and the BOP percentage than placebo , both at the 3-month and 6-month examinations .
RESULTS	Furthermore , both active solutions showed a higher extent of staining of the teeth than placebo during these two observation periods .
RESULTS	Rinsing with chlorhexidine resulted in more dental calculus than placebo after 6 months .
RESULTS	Chlorhexidine showed lower scores for plaque formation and gingivitis development but higher scores of supragingival dental calculus ( after 6 months ) and tooth staining than did delmopinol .
RESULTS	Both active solutions were reported by the patients -- approximately to the same extent but more frequently than placebo -- to induce taste alterations and a transient anaesthetic sensation of the oral mucosa .
RESULTS	However , subjective staining of the teeth and tongue was reported by 16 % of the delmopinol patients , but by 86 % of the patients rinsing with chlorhexidine for 6 months .
RESULTS	Furthermore , 24 % of the patients in the chlorhexidine group , 9 % in the delmopinol group and 4 % in the placebo group wished to withdraw from treatment .
CONCLUSIONS	The results from this clinical trial indicate that supervised rinsing with 0.2 % delmopinol hydrochloride or with 0.2 % chlorhexidine digluconate twice daily for 60 s as a supplement to normal mechanical oral hygiene procedures resulted in less plaque formation and gingivitis than rinsing with placebo .
CONCLUSIONS	Although chlorhexidine was more effective than delmopinol regarding plaque formation and gingivitis , it was considered by the patients as less tolerable .

###16608934
BACKGROUND	Impaired exercise tolerance is frequently observed in patients with COPD .
BACKGROUND	Respiratory muscle endurance training ( RMET ) by means of normocapnic hyperpnea can be used to improve respiratory muscle function and probably exercise capacity .
BACKGROUND	RMET is not applied on a large scale because complicated equipment is needed to maintain carbon dioxide homeostasis during hyperpnea , which can also be done by enlarging the dead space of the ventilatory system by breathing through a tube .
BACKGROUND	Therefore , tube breathing might be a new , inexpensive method for home-based RMET .
BACKGROUND	The aim of this study was to assess whether home-based RMET by means of tube breathing improves endurance exercise performance in patients with COPD .
METHODS	We randomized 36 patients with moderate-to-severe COPD to RMET by paced tube breathing ( n = 18 ) or sham training ( control , n = 18 ) .
METHODS	Both groups trained twice daily for 15 min , 7 days per week , for 5 weeks .
RESULTS	Patients receiving RMET showed significant improvements in endurance exercise capacity ( constant-load exercise on cycle ergometry ; 18 min vs 28 min , p < 0.001 ) , in perception of dyspnea ( Borg score ; 8.4 vs 5.4 , p < 0.001 ) , and respiratory muscle endurance capacity ( sustainable inspiratory pressure ; 25 cm H ( 2 ) O vs 31 cm H ( 2 ) O , p = 0.005 ) .
RESULTS	Quality of life ( chronic respiratory disease questionnaire ) also improved ( 78.7 to 86.6 , p = 0.001 ) .
RESULTS	The control group showed no significant changes .
CONCLUSIONS	Home-based RMET by means of tube breathing leads to a significant improvement of endurance exercise capacity , a reduction in perception of dyspnea , and an improvement in quality of life in patients with moderate-to-severe COPD .

###15125904
OBJECTIVE	Previous studies have shown an increase in leukotrienes in the uterine tissue as well as in the menstrual flow of adult women with dysmenorrhea .
OBJECTIVE	An increase in leukotriene-E4 , the major urinary leukotriene , was also reported in adolescent girls with dysmenorrhea , further suggesting a possible involvement of these potent vasoconstrictors and inflammatory mediators in generating dysmenorrhea symptoms .
OBJECTIVE	In the present study we examined whether blocking leukotrienes might alleviate symptoms of dysmenorrhea in adolescents .
METHODS	Twenty-five adolescents ( age 16 + / - 1 years , 4 + / - 1 years post menarche , body mass index 23 + / - 1 ) with dysmenorrhea participated in a randomized , double blind , crossover study .
METHODS	Thirteen girls received one tablet of montelukast ( Singulair , Merck , West Point , PA ) 10 mg daily starting on day 21 of the cycle until the last day of the menstrual period for two menstrual cycles , followed by one tablet of placebo ( Merck , West Point , PA ) daily starting on day 21 of the cycle until the last day of the menstrual period for two additional menstrual cycles .
METHODS	The other 12 girls had a reverse schedule starting with placebo .
METHODS	Participants were instructed to use one or two 200-mg tablets of ibuprofen every 6 h in the event of continuing menstrual symptoms .
METHODS	The Cox Menstrual Symptom Scale was used to assess response to treatment .
METHODS	An intent-to-treat approach was used for data analysis .
RESULTS	Twenty-two girls completed the study .
RESULTS	Two girls were noncompliant with the study protocol , and one was withdrawn because of Helicobacter pylori infection .
RESULTS	Compared with Cox menstrual score ( mean + / - SE ) before study ( 46 + / - 6 ) , there was no significant change in menstrual symptoms during treatment with placebo ( Cox score 42 + / - 7 ) or during treatment with montelukast ( Cox score 39 + / - 7 ) , and there was no significant difference between montelukast and placebo treatments as well .
RESULTS	Likewise , there was no significant difference between the amount of ibuprofen tablets consumed during the menstrual periods before study ( 4 + / - 1 ) , while on placebo ( 3 + / - 1 ) , and while on montelukast ( 4 + / - 1 ) .
CONCLUSIONS	This study does not support the use of montelukast , in the current FDA-approved dose ( for asthma ) and commencing immediately before the menstrual period , for treatment of dysmenorrhea .
CONCLUSIONS	It remains to be determined in further studies whether a higher dose or a prolonged daily use of montelukast may alleviate symptoms of dysmenorrhea in adolescents .

###20408890
OBJECTIVE	The acquisition of adequate vaccine-induced humoral immunity is especially important in HIV-infected individuals , who are at increased risk of infections .
OBJECTIVE	The aim of the study was to assess the safety of administering a complete vaccination programme to successfully treated HIV-infected adults and to evaluate specific humoral responses and the effect of highly active antiretroviral therapy ( HAART ) interruption on these responses .
METHODS	A placebo-controlled , double-blind clinical trial was designed and 26 HIV-infected adults enrolled .
METHODS	Study participants were randomized to receive either a complete immunization schedule with commercial vaccines or placebo for 12 months .
METHODS	HAART was then discontinued for 6 months .
METHODS	Specific humoral responses were evaluated at baseline , at month 12 and after HAART interruption and compared between groups .
RESULTS	There were neither local nor systemic secondary effects related to vaccination .
RESULTS	Specific humoral responses to vaccines were adequate , but a loss of immunoglobulin G titres was observed after HAART interruption in 12 study participants .
CONCLUSIONS	HAART interruption may cause impairment of previously acquired vaccine-induced immunity in HIV-infected adults .

###12799102
BACKGROUND	Many studies have shown that hormone replacement therapy ( HRT ) might provide protection against the development of hypertension and arteriosclerosis in postmenopausal women .
BACKGROUND	However , the precise mechanism underlying its benefits is unclear .
BACKGROUND	This question was addressed in an electron spin resonance ( EPR ) study of membrane function of erythrocytes in postmenopausal women .
BACKGROUND	The purpose of this study was to investigate the effects of HRT on membrane fluidity of erythrocytes in postmenopausal women by means of the EPR and spin-labeling method .
METHODS	The healthy postmenopausal women were randomly divided into the HRT group ( n = 14 ) receiving the conjugated estrogen with medroxyprogesterone for 3 months and the non-HRT control group ( n = 14 ) .
METHODS	We measured membrane fluidity of erythrocytes in postmenopausal women before and after the trial period .
RESULTS	The HRT group showed a significant decrease in blood pressure ( BP ) after treatment ( systolic BP 145.7 + / - 5.5 v 123.3 + / - 5.1 mm Hg , n = 14 , mean + / - SEM , P < .05 ) .
RESULTS	The order parameter ( S ) for 5-nitroxide stearate in the EPR spectra of erythrocyte membranes decreased significantly in the HRT group ( S : 0.718 + / - 0.002 v 0.695 + / - 0.002 , n = 14 , P < .01 ) .
RESULTS	The finding indicated that HRT increased the membrane fluidity of erythrocytes and improved the microviscosity of the cell membranes in postmenopausal women .
CONCLUSIONS	These results are consistent with the hypothesis that HRT might have a beneficial effect on the membrane rheologic behavior of erythrocytes and the microcirculation in postmenopausal women .

###24605812
BACKGROUND	Unwanted submental fat ( SMF ) may result in an unattractive chin profile and dissatisfaction with appearance .
BACKGROUND	An approved and rigorously tested non-surgical method for SMF reduction is lacking .
OBJECTIVE	To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized , double-blind , placebo-controlled study .
METHODS	Patients ( n = 360 ) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm ( 2 ) or placebo injected into their SMF for up to four treatments ~ 28 days apart , with a 12-week follow-up .
METHODS	Coprimary efficacy endpoints were the proportions of treatment responders , defined as a 1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale ( CR-SMFRS ) , and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale ( SSRS score 4 ) .
METHODS	Secondary efficacy endpoints included a 1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale ( PR-SMFRS ) and changes in the Patient-Reported Submental Fat Impact Scale ( PR-SMFIS ) .
METHODS	Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded .
METHODS	Adverse events ( AEs ) and laboratory test results were monitored .
RESULTS	Compared with placebo , a greater proportion of patients treated with ATX-101 1 and 2 mg/cm ( 2 ) showed a 1-point improvement in CR-SMFRS ( 58.3 % and 62.3 % , respectively , vs. 34.5 % with placebo ; P < 0.001 ) and patient satisfaction ( SSRS score 4 ) with the appearance of their face and chin ( 68.3 % and 64.8 % , respectively , vs. 29.3 % ; P < 0.001 ) .
RESULTS	Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity ( PR-SMFRS ; P = 0.009 for ATX-101 1 mg/cm ( 2 ) , P < 0.001 for ATX-101 2 mg/cm ( 2 ) vs. placebo ) and emotions and perceived self-image ( PR-SMFIS ; P < 0.001 ) .
RESULTS	No overall worsening of skin laxity was observed .
RESULTS	AEs were mostly transient , mild to moderate in intensity and localized to the treatment area .
CONCLUSIONS	ATX-101 was effective and well tolerated , and may be an alternative to surgery for patients desiring improvement of their submental profile .

###15528779
BACKGROUND	Among elderly persons , falls account for 87 % of all fractures and are contributing factors in many nursing home admissions .
BACKGROUND	This study evaluated the effect of an easily implemented , low-intensity exercise program on the incidence of falls and the time to first fall among a clinically defined population of elderly men and women .
METHODS	This community-based , randomized trial compared the exercise intervention with a no-intervention control .
METHODS	The participants were 294 men and women , aged 60 years or older , who had either a hospital admission or bed rest for 2 days or more within the previous month .
METHODS	Exercise participants were scheduled to attend exercise sessions lasting 45 minutes , including warm-up and cool-down , 3 times a week for 8 weeks ( 24 sessions ) .
METHODS	Assessments included gait and balance measures , self-reported physical function , the number of medications being taking at baseline , participant age , sex , and history of falling .
METHODS	Falls were tracked for 1 year after each participant 's baseline assessment .
RESULTS	29 % of the study participants reported a fall during the study period .
RESULTS	The effect of exercise in preventing falls varied significantly by baseline physical function level ( p < or = .002 ) .
RESULTS	The risk for falls decreased for exercise participants with low baseline physical functioning ( hazard ratio , .51 ) but increased for exercise participants with high baseline physical functioning ( hazard ratio , 3.51 ) .
CONCLUSIONS	This easily implemented , low-intensity exercise program appears to reduce the risk for falls among elderly men and women recovering from recent hospitalizations , bed rest , or both who have low levels of physical functioning .

###16603776
OBJECTIVE	To compare the level of pain experienced by patients during transrectal ultrasound-guided prostatic biopsy using intrarectal 2 % lidocaine gel versus plain lubricant gel .
METHODS	Prospective double-blind randomised controlled trial .
METHODS	Regional hospital , Hong Kong .
METHODS	From March 2002 to December 2003 , patients who underwent ultrasound-guided prostate biopsy at a Geriatric Urology Centre .
METHODS	Pain and discomfort scores measured by horizontal visual analogue scales .
RESULTS	A total of 338 consecutive patients were randomised to lidocaine gel or plain lubricant gel groups .
RESULTS	The two groups were statistically similar in demographic and disease characteristics .
RESULTS	There were no significant statistical differences in pain or discomfort score in the lidocaine gel and plain lubricant groups -- pain score : 1.75 versus 1.79 ( P = 0.66 ) on day 0 and 0.21 versus 0.15 ( P = 0.97 ) on day 1 ; discomfort score : 0.79 versus 0.77 ( P = 0.86 ) on day 0 and 0.12 versus 0.12 ( P = 0.76 ) on day 1 .
RESULTS	No major complications were recorded in this cohort .
CONCLUSIONS	Transrectal ultrasound-guided trucut biopsy of the prostate can be safely performed with no anaesthesia in Chinese patients .
CONCLUSIONS	Pain and discomfort are minimal .
CONCLUSIONS	It was found that 2 % lidocaine gel has no statistical therapeutic or analgesic benefit over plain lubricant gel .

###9884248
BACKGROUND	The success of liver transplantation in this decade has become the stimulus to extend the donor and recipient pool .
BACKGROUND	Reducing early posttransplant morbidity to maintain our success , as we expand our frontiers , has led us to focus on balanced testing of multidrug immunosuppression regimens .
METHODS	A prospective trial in orthotopic liver transplantation using Mycophenolate Mofetil and an identical steroid taper with randomization of patients to Neoral ( N ) or Tacrolimus ( FK ) is the basis of this report .
METHODS	This was an intent-to-treat study designed to compare the 6-month primary endpoints of rejection and infection and to compare the 6-month secondary endpoints of liver function , renal function , bone marrow function , hypertension , and serum cholesterol levels .
RESULTS	Ninety-seven patients completed the 6-month follow-up period ( N = 49 , FK = 48 ) .
RESULTS	The actual 6-month patient and graft survival rates were 98 % and 94 % , respectively .
RESULTS	There was no difference in the number of patients with rejection episodes ( N = 11 , FK = 8 ) ( P = 0.61 ) .
RESULTS	There were 24 infections ( 3 cytomegalovirus ) in the FK group and 30 infections ( 9 cytomegalovirus ) in the N group .
RESULTS	The cholesterol levels at 6 months were not significantly different ( P = 0.07 ) between the groups .
RESULTS	The other secondary 6-month endpoints were not significantly different , except total bilirubin , which was lower in the FK arm ( P = 0.02 ) .
CONCLUSIONS	The use of Mycophenolate Mofetil with N or FK and an identical steroid taper after orthotopic liver transplantation is associated with excellent graft and patient survival , and at 6 months , only 191 % of the patients experienced rejection , with a 48 % overall infection rate .

###9548613
BACKGROUND	The Maastricht Consensus Report advises that , in Helicobacter pylori-positive patients after surgery for peptic ulcer disease , H. pylori should be eradicated .
BACKGROUND	The aim of the present study was to investigate the symptomatic response of H. pylori eradication in previously vagotomized peptic ulcer patients with persistent dyspeptic complaints .
METHODS	The study was performed as a randomized , double-blind , placebo-controlled study .
METHODS	Pretreatment diagnostic upper endoscopy was omitted .
METHODS	All the results were submitted to intention-to-treat and efficacy analyses .
RESULTS	We could not find any differences between the two groups with regard to intensity or frequency of upper abdominal pain , nausea , heartburn , or other abdominal symptoms during the 12-month follow-up .
RESULTS	The triple therapy eradication rate was 88 % at both 3 - and 12-month controls .
CONCLUSIONS	Vagotomized peptic ulcer patients with persistent dyspeptic complaints should undergo a diagnostic upper endoscopy to detect ulcer recurrence before H. pylori eradication treatment is considered .

###19069579
OBJECTIVE	The aim was to investigate the role of nicotine gum and pretreatment depressive symptoms in long-term smoking cessation .
METHODS	12-month follow-up of 608 participants within a randomized , controlled trial was conducted .
METHODS	Participants received brief counseling plus nicotine or placebo treatment .
METHODS	Based on the Center for Epidemiological Studies Depression Scale pre-treatment score ( > or = 16 ) , 32 % of the participants were classified as depressed at baseline .
RESULTS	At the 12-month follow-up the non-depressed participants with nicotine replacement therapy ( NRT ) were most successful ( 20.1 % ) , while the depressed ones with placebo were least successful ( 5.7 % ) ( p = .004 ) .
RESULTS	However , the depressed participants with NRT ( 15.1 % ) were not significantly less successful than the non-depressed ones with NRT ( 20.1 % , p = .23 ) .
RESULTS	Survival analysis showed significant depression ( p = .01 ) and treatment effects ( p = < .001 ) on the abstinence .
RESULTS	Further , when adjusted for marital status and education , the treatment effect remained significant ( p < .001 ) , whereas the depression effect became non-significant ( p = .08 ) .
CONCLUSIONS	NRT improved cessation both among the depressed and non-depressed .
CONCLUSIONS	To understand discrepancies in literature reporting depression and smoking cessation outcome , the pharmacological treatment modality and social-demographic variables should be examined as additional variables .

###1832372
OBJECTIVE	To describe the frequency of aerosol pentamidine-induced bronchoconstriction , its relationship to non-specific airway responsiveness , and its response to preventive therapy using salbutamol , ipratropium bromide , or sodium cromoglycate .
METHODS	Consecutive HIV-infected individuals starting prophylactic AP were eligible if they had not been previously treated with this agent .
METHODS	Simple spirometry was performed before and 10 min after a single 60-mg dose given through an ultrasonic nebulizer .
METHODS	Methacholine challenge was performed in all subjects 24 h to four days after the initial AP dose .
METHODS	Subjects with a change in FEV1 ( delta FEV1 ) greater than or equal to 10 percent decrease after the initial AP dose were restudied on three separate occasions ( greater than 24 hours apart ) after premedication with two puffs of salbutamol ( 200 micrograms ) , ipratropium bromide ( 40 micrograms ) , or sodium cromoglycate ( 2 mg ) , in random order .
RESULTS	Fifty-three subjects were studied .
RESULTS	The median delta FEV1 after a single dose of AP was -7.0 percent ( range : -47 percent , 1.8 percent ) .
RESULTS	The delta FEV1 following AP was only partially predicted by the degree of nonspecific bronchial responsiveness as measured by a standard methacholine challenge .
RESULTS	Age , current smoking , history of asthma , baseline FEV1 , or a prior episode of PCP failed to predict the delta FEV1 following AP .
RESULTS	Eighteen subjects ( 34 percent ) had a delta FEV1 greater than or equal to 10 percent decrease ( median : -17.0 percent ) .
RESULTS	In these subjects , after premedication with salbutamol , ipratropium bromide , and sodium cromoglycate , the median delta FEV1 was 1.0 , 0.8 , and -9.6 percent , respectively .
CONCLUSIONS	Aerosol pentamidine produced a decrease in FEV1 greater than or equal to 10 percent in 34 percent of subjects .
CONCLUSIONS	This was not accurately predicted by the methacholine response .
CONCLUSIONS	The bronchoconstriction induced by AP was effectively prevented by either salbutamol or ipratropium , whereas cromoglycate was only partially effective .

###19395578
BACKGROUND	The best method to interpret the chest roentgenogram and its sensitivity to detect effect of treatment for sarcoidosis remains unclear .
BACKGROUND	In a double-blind , randomized trial of infliximab for chronic pulmonary sarcoidosis , changes in serial chest roentgenograms were examined by radiologists , blinded to order or treatment .
METHODS	Chest roentgenograms were obtained at 0 , 6 , and 24 weeks of therapy with either placebo , 3 mg/kg infliximab , or 5 mg/kg infliximab .
METHODS	Films were reviewed in random order by two independent radiologists , unaware of treatment .
METHODS	The films were compared using two methods : the prespecified objective assessment , a scoring system previously proposed by Muers ; and the post hoc assessment , a 5-point Likert scale global assessment between two films .
RESULTS	Of 138 patients enrolled in the study , chest roentgenograms for all studies were available on 130 patients .
RESULTS	There was only fair agreement between the two radiologists in the original stage of the chest roentgenogram ( weighted kappa = 0.43 ; 95 % confidence interval [ CI ] , 0.32 to 0.54 ) .
RESULTS	For the Likert scale of global assessment of change , there was good agreement between the two readers ( weighted kappa = 0.61 ; 95 % CI , 0.51 to 0.71 ) .
RESULTS	There was good correlation between the two readers for the various components of the Muers score , especially the reticulonodular ( R ) score ( R = 0.578 ; p < 0.05 ) .
RESULTS	The initial R score was positively correlated with improvement in FVC with infliximab therapy ( R = 0.239 ; p < 0.05 ) .
CONCLUSIONS	Global assessment and the Muers scoring system were associated with good agreement between two expert readers .
CONCLUSIONS	Improvement in both scores correlated with improvement in FVC .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00073437 .

###9870539
OBJECTIVE	Previous research has shown that patients ' evaluations of their prostheses correlate poorly with the clinicians ' assessments , as well as with intraoral anatomic factors .
OBJECTIVE	It has been recommended that researchers conduct more studies that use patient satisfaction as the primary outcome measure in treatment evaluation and that more attention be paid to understanding exactly what measures of patient satisfaction represent .
OBJECTIVE	In this study , the relationship between patients ' ratings of general satisfaction and their perceptions of different aspects of mandibular prostheses is investigated .
METHODS	One hundred and twenty subjects applied to participate in a randomized controlled clinical trial comparing two types of mandibular prostheses : conventional dentures and implant prostheses .
METHODS	At baseline , they were asked to rate on 100 mm visual analog scales ( VAS ) factors that edentulous patients indicated were important to them .
METHODS	These included comfort , ability to chew , stability , esthetics , ability to speak and ease of cleaning of their conventional dentures .
METHODS	Subjects were also asked to rate their general satisfaction with their dentures .
METHODS	In addition , they selected the one quality of their denture that they considered to be most important .
RESULTS	Multiple regression methods revealed that gender , as well as patients ' ratings of comfort , stability , esthetics , ability to chew and ability to speak with their prostheses contributed significantly to general satisfaction ( F < 0.0001 ) .
RESULTS	Furthermore , 89 % of the variation in ratings of general satisfaction was explained by these factors .
RESULTS	In addition , patients who considered ability to chew as the most important factor associated with their dentures rated their general satisfaction significantly higher than the other subjects ( P = 0.0003 ) .
CONCLUSIONS	Patient satisfaction with conventional dental prostheses is highly dependent on gender , and the appearance and functionality of the appliance .
CONCLUSIONS	The combined effect of these factors explained most of the variation in the satisfaction ratings .

###17347859
OBJECTIVE	Several products are being widely promoted for reduction of the concentration of alcohol in the human body .
OBJECTIVE	One of these preparations , the fructose soft drink Outox , claims to noticeably increase the alcohol elimination rate ( beta 60 ) .
OBJECTIVE	Theories to explain this ` fructose effect ' are based on the assumption that NAD + , the coenzyme for alcohol dehydrogenase , is regenerated faster in the presence of fructose .
METHODS	A randomized double-blind , placebo-controlled cross-over study was performed with 30 volunteers in two drinking sessions each .
METHODS	Under strictly identical conditions , the same amount of alcohol was consumed , followed by the consumption of either 250 ml Outox or 250 ml placebo .
METHODS	Periodical measurements of blood ( BAC ) , breath ( BrAC ) and urine alcohol concentration ( UAC ) were performed .
RESULTS	Analyses revealed a significant difference ( P < 0.0001 ) between the mean alcohol levels of the Outox and the placebo drinking sessions .
RESULTS	The overall mean BAC difference was 0.077 g/l ( BAC 0.748 g/l without vs 0.671 g/l with Outox ) , equivalent to 10.3 % .
RESULTS	The mean BrAC difference was 0.045 mg/l ( BrAC 0.314 mg/l without vs 0.269 mg/l with Outox ) , equivalent to 14.3 % .
RESULTS	Differences were lower for women than for men .
RESULTS	A significant difference between the alcohol elimination rates ( beta 60 ) was not found .
CONCLUSIONS	The results show that the soft drink Outox may decrease the alcohol concentration by about 10 % .
CONCLUSIONS	However , BAC and BrAC differences are rather a consequence of slower gastric absorption of alcohol , because Outox does not increase the alcohol elimination rate .
CONCLUSIONS	Our study demonstrates that the claim of Outox or other fructose drinks to work as a ` soberade ' can not be proven from a scientific point of view .
CONCLUSIONS	It should be the task of physicians to warn potential consumers , especially in connection with drinking and driving .

###19287286
OBJECTIVE	To evaluate the efficacy of intravitreal injections of two different dosages of bevacizumab ( Avastin ) for treating diffuse diabetic macular edema .
METHODS	Fifty-two eyes of 52 patients with diabetic macular edema were randomized to receive three monthly intravitreal injections of 1.25 mg or 2.5 mg bevacizumab .
METHODS	Patients were observed for 6 months and optical coherence tomography central foveal thickness , logMAR best-corrected visual acuity ( BCVA ) , and adverse events were assessed .
RESULTS	Forty-eight eyes of 48 patients completed the 6-month follow-up and were analyzed .
RESULTS	Significant mean central foveal thickness reductions were observed in both groups at all follow-up visits ( P < 0.013 ) .
RESULTS	Significant improvements between baseline and 6-month mean logMAR BCVAs were seen , with the mean logMAR BCVA improved from 0.63 to 0.52 in the 1.25 mg group and 0.60 to 0.47 in the 2.5 mg group .
RESULTS	No significant difference in BCVA was observed between the two groups at any time point ( P > 0.56 ) .
RESULTS	Subgroup analysis showed that intravitreal bevacizumab seemed to be more effective in eyes without any previous diabetic macular edema treatment .
CONCLUSIONS	Three monthly intravitreal bevacizumab injections resulted in significant reduction in central foveal thickness and improvements in BCVA in diabetic macular edema patients .
CONCLUSIONS	Both 1.25 mg and 2.5 mg seemed to have similar treatment efficacy .

###19858419
BACKGROUND	Cardiac resynchronization therapy ( CRT ) improves LV structure , function , and clinical outcomes in New York Heart Association class III/IV heart failure with prolonged QRS .
BACKGROUND	It is not known whether patients with New York Heart Association class I/II systolic heart failure exhibit left ventricular ( LV ) reverse remodeling with CRT or whether reverse remodeling is modified by the cause of heart failure .
RESULTS	Six hundred ten patients with New York Heart Association class I/II heart failure , QRS duration > or = 120 ms , LV end-diastolic dimension > or = 55 mm , and LV ejection fraction < or = 40 % were randomized to active therapy ( CRT on ; n = 419 ) or control ( CRT off ; n = 191 ) for 12 months .
RESULTS	Doppler echocardiograms were recorded at baseline , before hospital discharge , and at 6 and 12 months .
RESULTS	When CRT was turned on initially , immediate changes occurred in LV volumes and ejection fraction ; however , these changes did not correlate with the long-term changes ( 12 months ) in LV end-systolic ( r = 0.11 , P = 0.31 ) or end-diastolic ( r = 0.10 , P = 0.38 ) volume indexes or LV ejection fraction ( r = 0.07 , P = 0.72 ) .
RESULTS	LV end-diastolic and end-systolic volume indexes decreased in patients with CRT turned on ( both P < 0.001 compared with CRT off ) , whereas LV ejection fraction in CRT-on patients increased ( P < 0.0001 compared with CRT off ) from baseline through 12 months .
RESULTS	LV mass , mitral regurgitation , and LV diastolic function did not change in either group by 12 months ; however , there was a 3-fold greater reduction in LV end-diastolic and end-systolic volume indexes and a 3-fold greater increase in LV ejection fraction in patients with nonischemic causes of heart failure .
CONCLUSIONS	CRT in patients with New York Heart Association I/II resulted in major structural and functional reverse remodeling at 1 year , with the greatest changes occurring in patients with a nonischemic cause of heart failure .
CONCLUSIONS	CRT may interrupt the natural disease progression in these patients .
CONCLUSIONS	Clinical Trial Registration - Clinicaltrials.gov Identifier : NCT00271154 .

###16763747
BACKGROUND	Changes in the composition of gastrointestinal microbiota by dietary interventions using pro- and prebiotics provide opportunity for improving health and preventing disease .
BACKGROUND	However , the capacity of lupin kernel fiber ( LKFibre ) , a novel legume-derived food ingredient , to act as a prebiotic and modulate the colonic microbiota in humans needed investigation .
OBJECTIVE	The present study aimed to determine the effect of LKFibre on human intestinal microbiota by quantitative fluorescent in situ hybridization ( FISH ) analysis .
METHODS	A total of 18 free-living healthy males between the ages of 24 and 64 years consumed a control diet and a LKFibre diet ( containing an additional 17-30 g/day fiber beyond that of the control-incorporated into daily food items ) for 28 days with a 28-day washout period in a single-blind , randomized , crossover dietary intervention design .
METHODS	Fecal samples were collected for 3 days towards the end of each diet and microbial populations analyzed by FISH analysis using 16S rRNA gene-based oligonucleotide probes targeting total and predominant microbial populations .
RESULTS	Significantly higher levels of Bifidobacterium spp .
RESULTS	( P = 0.001 ) and significantly lower levels of the clostridia group of C. ramosum , C. spiroforme and C. cocleatum ( P = 0.039 ) were observed on the LKFibre diet compared with the control .
RESULTS	No significant differences between the LKFibre and the control diet were observed for total bacteria , Lactobacillus spp. , the Eubacterium spp. , the C. histolyticum/C .
RESULTS	lituseburense group and the Bacteroides-Prevotella group .
CONCLUSIONS	Ingestion of LKFibre stimulated colonic bifidobacteria growth , which suggests that this dietary fiber may be considered as a prebiotic and may beneficially contribute to colon health .

###21946964
OBJECTIVE	To establish the efficacy of Mindfulness-based Stress Reduction ( MBSR ) for people with chronic health problems in managing symptoms and coping with their illness in an Aotearoa/New Zealand context .
METHODS	Twenty-nine participants completed a wait-list control study .
METHODS	Physical and psychological health and well-being were measured before , after and 6 months after the 8-week training programme using a variety of internationally recognised screening tools .
RESULTS	Statistically significant improvements were demonstrated in almost all categories measured .
CONCLUSIONS	MBSR demonstrated health benefits for chronic illness sufferers .
CONCLUSIONS	An economical and effective adjunctive therapy for decreasing morbidity associated with chronic illness in New Zealand , MBSR provides both clinicians and patients with an additional option for the better management of chronic illness .

###16652049
OBJECTIVE	To evaluate clinical , immunologic , and virologic performance of patients with nadir CD4 counts of > 350 cells/microL upon treatment interruption .
METHODS	Randomized , open-label clinical trial of 48 weeks ' duration .
METHODS	Patients on effective highly active antiretroviral therapy , with nadir CD4 counts of > 350 cells/microL and peak viral loads of < 50,000 copies/mL were randomized to continue therapy or to interrupt antiretroviral medication .
METHODS	End points for patients with treatment interruption were CD4 counts of < 350 cells/microL , viral loads of > 1 log above the pretherapy values , or clinical symptoms attributable to HIV , at which point treatment was restarted .
METHODS	In the continuation group , the end points were virologic failure , opportunistic infections , and treatment discontinuation due to toxicities .
RESULTS	Twenty patients were randomized to stop therapy and 16 patients to continue .
RESULTS	Median CD4 counts at baseline were 643 cells/microL for the interruption group and 633 cells/microL for the continuation group .
RESULTS	No end points were reached in the interruption group .
RESULTS	By week 8 , viral load returned to values comparable to those of pretherapy in all patients in the interruption group and remained stable until week 48 .
RESULTS	CD4 counts dropped in the interruption group ( median loss of 156 cells/microL ) at week 48 .
RESULTS	Significant decreases in venous lactate were observed in the interruption group .
CONCLUSIONS	Treatment interruptions in patients with nadir CD4 counts of > 350 cells/microL seem safe for at least 48 weeks .
CONCLUSIONS	Pretherapy viral load appears as a valuable tool to predict its level at week 48 .

###7707407
BACKGROUND	Regionally advanced , surgically unresectable non-small-cell lung cancer represents a disease with an extremely poor prognosis .
BACKGROUND	External-beam irradiation to the primary tumor and regional lymphatics is generally accepted as standard therapy .
BACKGROUND	The use of more aggressive radiation regimens and the addition of cytotoxic chemotherapy to radiotherapy have yielded conflicting results .
BACKGROUND	Recently , however , results from clinical trials using innovative irradiation delivery techniques or chemotherapy before irradiation have indicated that patients treated with protocols that incorporate these modifications may have higher survival rates than patients receiving standard radiation therapy .
OBJECTIVE	On the basis of these results , the Radiation Therapy Oncology Group ( RTOG ) - Eastern Cooperative Oncology Group ( ECOG ) elected to conduct a phase III trial comparing the following regimens : 1 ) standard radiation therapy , 2 ) induction chemotherapy followed by standard radiation therapy , and 3 ) twice-daily radiation therapy .
METHODS	Patients with surgically unresectable stage II , IIIA , or IIIB non-small-cell lung cancer were potential candidates .
METHODS	Staging was nonsurgical .
METHODS	Patients were required to have a Karnofsky performance status of 70 or more and weight loss less than 5 % for 3 months prior to entry into the trial , to be older than 18 years of age , and to have no metastatic disease .
METHODS	Of the 490 patients registered in the trial , 452 were eligible .
METHODS	The disease in 95 % of the patients was stage IIIA or IIIB .
METHODS	More than two thirds of the patients had a Karnofsky performance status of more than 80 .
METHODS	Patients were randomly assigned to receive either 60 Gy of radiation therapy delivered at 2 Gy per fraction , 5 days a week , over a 6-week period ( standard radiation therapy ) ; induction chemotherapy consisting of cisplatin ( 100 mg/m2 ) on days 1 and 29 and 5 mg/m2 vinblastine per week for 5 consecutive weeks beginning on day 1 with cisplatin , followed by standard radiation therapy starting on day 50 ; or 69.6 Gy delivered at 1.2 Gy per fraction twice daily ( hyperfractionated radiation therapy ) .
RESULTS	Toxicity was acceptable , with four treatment-related deaths .
RESULTS	Three patients subsequently died of chronic pulmonary complications .
RESULTS	Compliance with protocol treatment was acceptable .
RESULTS	One-year survival ( % ) and median survival ( months ) were as follows : standard radiation therapy -- 46 % , 11.4 months ; chemotherapy plus radiotherapy -- 60 % , 13.8 months ; and hyperfractionated radiation therapy -- 51 % , 12.3 months .
RESULTS	The chemotherapy plus radiotherapy arm was statistically superior to the other two treatment arms ( logrank P = .03 ) .
CONCLUSIONS	In `` good-risk '' patients with surgically unresectable non-small-cell lung cancer , induction chemotherapy followed by irradiation was superior to hyperfractionated radiation therapy or standard radiation therapy alone , yielding a statistically significant short-term survival advantage .

###12393771
BACKGROUND	We have compared the laryngeal tube and laryngeal mask in 22 patients for the success rate of insertion , gas leak pressure and the incidence of gastric insufflation .
METHODS	In a randomized , crossover design , the laryngeal tube and laryngeal mask were inserted in turn after induction of anaesthesia and neuromuscular block .
METHODS	The cuffs were inflated until the intracuff pressure reached 60 cm H ( 2 ) O.
METHODS	We measured adequacy of ventilation and the minimum airway pressure at which gas leaked around the cuff .
METHODS	The presence or absence of gastric insufflation was studied at an inflation pressure of 20 cm H ( 2 ) O.
RESULTS	It was possible to ventilate through the laryngeal tube in 21 patients and through the laryngeal mask in 21 patients .
RESULTS	The mean leak pressure for the laryngeal tube ( 26 ( SD 5 ) cm H ( 2 ) O ) was significantly greater than that for the laryngeal mask ( 19 ( 4 ) cm H ( 2 ) O ) ( P < 0.01 ; 95 % confidence intervals for mean difference : 5.3-10 .2 cm H ( 2 ) O ) .
RESULTS	Gastric insufflation did not occur when the laryngeal tube was used and was noted in three patients when the laryngeal mask was used .
CONCLUSIONS	The laryngeal tube provides a better seal in the oropharynx than the laryngeal mask .

###22458492
OBJECTIVE	To assess the patient and cancer characteristics as well as outcomes of a large cohort of Australian men who chose active surveillance ( AS ) as initial management of their low-risk prostate cancer .
METHODS	Men treated by one surgeon who had chosen AS as the primary management for prostate cancer were identified from the records .
METHODS	The patient and cancer data recorded included : patient age , prostate-specific antigen ( PSA ) concentration at diagnosis , mode of prostate cancer detection .
METHODS	For prostate cancer diagnosed at prostate biopsy , data were collected for the number of cores taken as well as positive core number , cancer burden , and Gleason grade .
METHODS	Survival analysis was used to determine the duration of AS .
RESULTS	In all , 154 men with low-risk prostate cancer with a median ( range ) age 63.0 ( 36-81 ) years and a mean ( range ) PSA concentration of 6.5 ( 0.3-22 ) ng/mL underwent AS .
RESULTS	The median ( range ) duration of AS was 1.9 ( 0.1-16 .6 ) years .
RESULTS	AS was ceased in 29 patients ( 19 % ) after a mean ( range ) of 2.4 ( 0.2-7 .9 ) years .
RESULTS	Of these , 26 were upstaged , one chose curative treatment despite stable disease , and two died from disease not related to prostate cancer .
RESULTS	Actuarial analysis on the probability of still being on AS after 5 years was 61.9 % ( 95 % confidence interval [ CI ] 46.2-74 .2 % ) and after 10 years was 45.0 % ( 95 % CI 21.3-66 .2 % ) .
RESULTS	While the period of follow-up is short , there were no biochemical recurrences in men who underwent curative treatment and no deaths from prostate cancer .
CONCLUSIONS	AS is an acceptable mode of initial treatment in Australian men with low-risk prostate cancer .

###20504899
OBJECTIVE	We hypothesized that insulin detemir mixed with aspart had equivalent effects on blood glucose as if being given as separate injections in pediatric type 1 diabetes patients .
METHODS	Fourteen children with type 1 diabetes were randomly assigned to either Study A ( mixed insulins ) or Study B ( separate insulins ) for the first 10 days and crossed over for the last 10 days .
METHODS	Each subject underwent continuous glucose monitoring on the last 72 h of each study .
RESULTS	The 48-h area under the curve ( mmol/hour/l ) , M-value , and mean amplitude of glucose excursion ( mmol/l ) for Study A versus Study B were 457 + / - 70 versus 469 + / - 112 ( P = 0.58 ) , 39.67 + / - 15.37 versus 39.75 + / - 9.69 ( P = 0.98 ) , and 6.35 + / - 1.92 versus 5.98 + / - 0.92 ( P = 0.42 ) , respectively .
CONCLUSIONS	Insulin detemir mixed with aspart had equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes .

###10407485
OBJECTIVE	To determine pharmacokinetics of single and multiple doses of rimantadine hydrochloride in horses and to evaluate prophylactic efficacy of rimantadine in influenza virus-infected horses .
METHODS	5 clinically normal horses and 8 horses seronegative to influenza A.
METHODS	Horses were given rimantadine ( 7 mg/kg of body weight , i.v. , once ; 15 mg/kg , p.o. , once ; 30 mg/kg , p.o. , once ; and 30 mg/kg , p.o. , q 12 h for 4 days ) to determine disposition kinetics .
METHODS	Efficacy in induced infections was determined in horses seronegative to influenza virus A2 .
METHODS	Rimantadine was administered ( 30 mg/kg , p.o. , q 12 h for 7 days ) beginning 12 hours before challenge-exposure to the virus .
RESULTS	Estimated mean peak plasma concentration of rimantadine after i.v. administration was 2.0 micrograms/ml , volume of distribution ( mean + / - SD ) at steady-state ( Vdss ) was 7.1 + / - 1.7 L/kg , plasma clearance after i.v. administration was 51 + / - 7 ml/min/kg , and beta-phase half-life was 2.0 + / - 0.4 hours .
RESULTS	Oral administration of 15 mg of rimantadine/kg yielded peak plasma concentrations of < 50 ng/ml after 3 hours ; a single oral administration of 30 mg/kg yielded mean peak plasma concentrations of 500 ng/ml with mean bioavailability ( F ) of 25 % , beta-phase half-life of 2.2 + / - 0.3 hours , and clearance of 340 + / - 255 ml/min/kg .
RESULTS	Multiple doses of rimantadine provided steady-state concentrations in plasma with peak and trough concentrations ( mean + / - SEM ) of 811 + / - 97 and 161 + / - 12 ng/ml , respectively .
RESULTS	Rimantadine used prophylactically for induced influenza virus A2 infection was associated with significant decreases in rectal temperature and lung sounds .
CONCLUSIONS	Oral administration of rimantadine to horses can safely ameliorate clinical signs of influenza virus infection .

###20592293
BACKGROUND	Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men .
BACKGROUND	The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied .
METHODS	Community-dwelling men , 65 years of age or older , with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter ( 3.5 to 12.1 nmol per liter ) or a free serum testosterone level of less than 50 pg per milliliter ( 173 pmol per liter ) were randomly assigned to receive placebo gel or testosterone gel , to be applied daily for 6 months .
METHODS	Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification .
METHODS	The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group .
RESULTS	A total of 209 men ( mean age , 74 years ) were enrolled at the time the trial was terminated .
RESULTS	At baseline , there was a high prevalence of hypertension , diabetes , hyperlipidemia , and obesity among the participants .
RESULTS	During the course of the study , the testosterone group had higher rates of cardiac , respiratory , and dermatologic events than did the placebo group .
RESULTS	A total of 23 subjects in the testosterone group , as compared with 5 in the placebo group , had cardiovascular-related adverse events .
RESULTS	The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period .
RESULTS	As compared with the placebo group , the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load .
CONCLUSIONS	In this population of older men with limitations in mobility and a high prevalence of chronic disease , the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events .
CONCLUSIONS	The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00240981 . )

###25056504
OBJECTIVE	The aim of the current study was to compare the effects of intraoperative infusion of 20 % human albumin versus 0.9 % normal saline on early and late graft function in renal transplantation .
METHODS	This prospective , randomized study was conducted on 44 patients with end-stage renal disease undergoing kidney transplantation .
METHODS	Patients were 32 males ( 72.7 % ) and 12 females ( 27.3 % ) with a mean age of 54.35 11.15 years ( range 20-58 years ) .
METHODS	Patients with cardiac disease and liver dysfunction were excluded from the study .
METHODS	Twenty-two of the 44 patients were given intraoperative intravenous infusion of 20 % human albumin with 0.9 % normal saline ( albumin group ) , and the remaining 22 patients received intraoperative intravenous infusion of 0.9 % normal saline alone ( saline group ) , as part of the intraoperative fluid hydration to keep central venous pressure between 10 and 15 mm of Hg .
RESULTS	There was no statistically significant difference in mean intravenous fluid volume infused until the end of surgery between the saline group and the albumin group ( P = 0.8326 ) .
RESULTS	Time of onset of diuresis and total intraoperative urine output were statistically insignificant between the two groups ( P = 0.6255 , P = 0.9231 , respectively ) .
RESULTS	Post-transplant serum creatinine on day 1 , 3 and 5 between the albumin and saline groups were comparable ( P = 0.8998 , P = 0.7257 , P = 0.8092 , respectively ) .
RESULTS	Post-transplant urine output on day 1 , 3 and 5 between the albumin and saline groups were also comparable ( P = 0.653 , P = 0.9075 , P = 0.946 , respectively ) .
RESULTS	Mean postoperative weight gain was higher in the saline group compared with the albumin group , but was not statistically significant ( P = 0.6348 ) .
CONCLUSIONS	This study revealed that the use of 20 % human albumin as an intraoperative volume expander provides no more benefit than the use of 0.9 % normal saline in terms of immediate graft function in living donor renal transplantation .

###22333169
OBJECTIVE	To evaluate the effect of psychological and behavioral intervention combined with varenicline smoking cessation clinics and to analyze predictors of successful quitting .
METHODS	Subjects were collected from quitters who went to receive consultation and intervention in `` smoking and related diseases '' clinic at Zhongshan Hospital , Fudan University from March 2009 to September 2010 .
METHODS	Eligible subjects were screened and divided into strengthen follow-up group and control group .
METHODS	The 4 weeks continuous abstinence rate from week 9 through week 12 were observed logistic regression model and used to analyze the predictors of successful quitting .
RESULTS	Subjects who are addicted to nicotine received strengthening psychological and behavioral intervention combined with varenicline in smoking cessation clinics .
RESULTS	The total continuous cessation rate during the 9 ( th ) - 12 ( th ) week was 52.3 % , with 60.9 % ( 28/46 ) and 46.2 % ( 30/65 ) of strengthen follow-up group and control group respectively .
RESULTS	The most frequent adverse effects were nausea 39.6 % ( 44/111 ) , insomnia and abnormal dreams 17.1 % ( 19/111 ) .
RESULTS	Adverse effects were tolerable and withdraw symptoms were few .
RESULTS	Preparation and medication time can be used as predictors of successful quitting .
CONCLUSIONS	The quit rate of varenicline therapy combining with strengthen intervention is high and strengthening psychological and behavioral intervention could increase the success rate more obviously , which is a good choice for cessation therapy in smoking cessation clinics .
CONCLUSIONS	Better preparation and regular adequate treatment can improve quit rate .

###9407576
OBJECTIVE	The aim of this study was to examine the effect of psychogeriatric intervention in a group of elderly medical inpatients over 75 years of age .
OBJECTIVE	In addition to usual care , intervention consisted of multidisciplinary joint treatment by a psychogeriatric team .
OBJECTIVE	The main purpose of intervention was to obtain the optimal level of physical functioning .
METHODS	In a prospective randomized trial the effect of the intervention ( N = 140 ) compared with usual care ( N = 97 ) was estimated for physical functioning , length of stay , and nursing home placement within 12 months of discharge .
RESULTS	Substantially more patients assigned to the intervention group improved in their physical functioning , and fewer became worse .
RESULTS	The mean length of stay was 5 days shorter for the intervention group .
RESULTS	There were more readmissions to hospital in the usual care group ( 29.9 % ) compared with the intervention group ( 17.4 % ) .
RESULTS	Of the patients assigned to the intervention treatment , 18 % were admitted to a nursing home .
RESULTS	In the usual care group this was 27 % .
RESULTS	The effects of intervention remained statistically significant for all the outcome variables after controlling for possible confounding baseline characteristics .
CONCLUSIONS	The intervention we studied had clinically relevant effects on important outcome variables .
CONCLUSIONS	Psychiatric co-morbidity was an important risk factor for the outcome of the patients in our study .
CONCLUSIONS	By combining elements from a psychiatric and geriatric consultation service with elements from a unit-driven service , we were able to improve health care for the elderly in our hospital in a feasible and cost-effective way .

###21156983
BACKGROUND	Short - and long-acting local anesthetics are commonly mixed to achieve nerve blocks with short onset and long duration .
BACKGROUND	However , there is a paucity of data on advantages of such mixtures .
BACKGROUND	We hypothesized that a mixture of mepivacaine and bupivacaine results in a faster onset than does bupivacaine and in a longer duration of blockade than does mepivacaine .
METHODS	Sixty-four patients undergoing arthroscopic shoulder surgery ( ages 18 to 65 years ; ASA physical status I-II ) with ultrasound-guided interscalene brachial plexus block as the sole anesthetic were studied .
METHODS	The subjects were randomized to receive 1 of 3 study solutions : 30 mL of mepivacaine 1.5 % , 30 mL of bupivacaine 0.5 % , or a mixture of 15 mL each of bupivacaine 0.5 % and mepivacaine 1.5 % .
METHODS	The block onset time and duration of motor and sensory block were assessed .
RESULTS	Onset of sensory block in the axillary nerve distribution ( superior trunk ) was similar among the 3 groups ( 8.7 4.3 minutes for mepivacaine , 10.0 5.1 minutes for bupivacaine , and 11.3 5.3 minutes for the combination group ; P = 0.21 between all groups ) .
RESULTS	The duration of motor block for the combination group ( 11.5 4.7 hours ) was between that of the bupivacaine ( 16.4 9.4 hours ) and mepivacaine ( 6.0 4.2 hours ) groups ( P = 0.03 between bupivacaine and combination groups ; P = 0.01 between mepivacaine and combination groups ) .
RESULTS	Duration of analgesia was the shortest with mepivacaine ( 4.9 2.4 hours ) , longest with bupivacaine ( 14.0 6.2 hours ) , and intermediate with the combination group ( 10.3 4.9 hours ) ( P < 0.001 for mepivacaine vs. combination group ; P = 0.01 for bupivacaine vs. combination group ) .
CONCLUSIONS	For ultrasound-guided interscalene block , a combination of mepivacaine 1.5 % and bupivacaine 0.5 % results in a block onset similar to either local anesthetic alone .
CONCLUSIONS	The mean duration of blockade with a mepivacaine-bupivacaine mixture was significantly longer than block with mepivacaine 1.5 % alone but significantly shorter than the block with bupivacaine 0.5 % alone .

###25203377
OBJECTIVE	The aim of this study was to compare the ligation of the intersphincteric fistula track with the mucosal advancement flap in the treatment of high transsphincteric anal fistulas .
METHODS	This was a prospective randomized study performed at academic medical centers .
METHODS	Patients with transsphincteric anal fistulas involving the upper part of anal sphincter were included .
METHODS	Patients were randomly assigned to either ligation of intersphincteric fistula track or mucosal advancement flap .
METHODS	The primary end points of the study were fistula closure , recurrence within 1 year , and continence by using the Wexner score .
METHODS	Secondary end points were morbidity , postoperative pain with the use of the visual analog scale , and quality of life with the use of the Cleveland Global Quality of Life score .
RESULTS	There were 70 patients ( 35 in each group ) .
RESULTS	Mean age was 36.1 years in patients undergoing ligation of the intersphincteric fistula track vs 32.9 years in patients undergoing mucosal advancement flap ( p = 0.33 ) .
RESULTS	Mean visual analog scale after 1 week was significantly higher in the mucosal advancement flap group than in the ligation of intersphincteric fistula track group ( 3.1 vs 4.8 , p = 0.04 ) , but no significant difference was found after 4 weeks .
RESULTS	Primary healing was achieved in 33 patients undergoing ligation of the intersphincteric fistula track vs 32 patients undergoing mucosal advancement flap ( p = 0.99 ) .
RESULTS	Mean healing time was 22.6 days in the ligation of intersphincteric fistula track group vs 32.1 days in mucosal advancement flap group ( p = 0.01 ) .
RESULTS	After 1 year of follow-up , successful outcome was achieved in 26 patients ( 74.3 % ) undergoing ligation of intersphincteric fistula track and in 20 patients ( 65.7 % ) undergoing mucosal advancement flap ( p = 0.58 ) .
RESULTS	No significant change in Wexner score occurred 4 weeks postoperatively .
RESULTS	There was no significant difference between groups regarding Cleveland Global Quality of Life score ( p = 0.5 and 0.07 after 4 and 12 weeks ) .
CONCLUSIONS	The short-term follow-up is a probable limitation .
CONCLUSIONS	Although the sample size was calculated to detect difference with 80 % power at a significance level of 5 % , the negative result within this relatively small number of patients might have resulted from type II statistical error .
CONCLUSIONS	In patients with high transsphincteric anal fistulas , both ligation of intersphincteric fistula track procedure and mucosal advancement flap have a similar long-term healing rate , recurrences , continence , and quality of life .
CONCLUSIONS	However , ligation of the intersphincteric fistula track has the advantage of less postoperative pain .

###9076206
OBJECTIVE	To explore morphological and vision changes in untreated eyes with subfoveal choroidal neovascularization ( CNV ) that have poorly demarcated boundaries .
METHODS	Analysis of photographs of untreated patients with poorly demarcated occult CNV participating in a prospective clinical trial evaluating laser treatment compared with observation .
METHODS	Two tertiary retinal referral centers .
METHODS	Symptomatic individuals with poorly demarcated subfoveal occult CNV associated with age-related macular degeneration .
METHODS	Change in size of lesion , development of classic CNV , change in vision , and development of subretinal fibrosis .
RESULTS	During follow-up ( 9-12 months ) , 32 % of the occult choroidal neovascular lesions more than doubled their original size .
RESULTS	Classic CNV developed in 52 % of eyes that started without it .
RESULTS	The median loss in visual acuity was 2.5 lines .
RESULTS	Eyes with classic CNV or subretinal blood or both at baseline developed subretinal fibrosis more frequently and lost more visual acuity , but not to a statistically significant degree .
CONCLUSIONS	The morphological changes of eyes with subfoveal occult CNV in which the boundaries are poorly demarcated in variable ; the presence of subretinal blood or a component of classic CNV may influence the prognosis for further loss of vision .

###11248828
OBJECTIVE	To compare the topical effects of tetracaine , lidocaine , and bupivacaine on corneal sensitivity in normal eyes .
METHODS	Corneal touch sensitivity was measured with a Cochet-Bonnet anesthesiometer before and at 2.5-minute intervals after instillation of the anesthetic agent , until baseline levels had been reestablished .
METHODS	Seventeen healthy volunteers were randomized into five groups .
METHODS	Group 1 included 0.5 % tetracaine ( n = 6 ) ; group 2 , 4 % lidocaine ( n = 8 ) ; group 3 , 0.75 % bupivacaine ( n = 8 ) ; group 4 , 0.5 % tetracaine + 4 % lidocaine ( n = 5 ) ; and group 5 , 0.5 % tetracaine + 0.75 % bupivacaine ( n = 7 ) .
RESULTS	The duration of anesthesia showed no differences between groups 1 , 3 , and 5 .
RESULTS	Although there was no difference between groups 2 and 4 , both groups demonstrated significantly longer effects than groups 1 , 3 , and 5 ( p < 0.005 ) .
CONCLUSIONS	The application of 4 % lidocaine results in a significantly prolonged topical anesthetic effect when compared with tetracaine and bupivacaine .

###16798663
OBJECTIVE	The most important risk factors for coronary heart disease are hypercholesterolemia , smoking and hypertension .
OBJECTIVE	To find out which treatment is more effective in modifying the total risk -- lowering cholesterol concentration or using antihypertensive treatment -- we conducted a parallel group placebo-controlled study .
OBJECTIVE	The goal of the study was to assess the effect of two drugs on the calculated CHD Framingham risk score in subjects with both moderate hypertension and moderate hypercholesterolemia .
METHODS	Celiprolol for hypertension and simvastatin for cholesterol-lowering were given as monotherapy or as combination treatment .
METHODS	The effects of the treatments on the CHD risk scores were calculated after 3 months .
METHODS	A total of 112 patients were randomized .
RESULTS	The total CHD risk decreased in simvastatin and combination groups from 26 % to 19 % and from 26 % to 17 % , respectively .
RESULTS	Celiprolol alone decreased the risk from 25 % to 21 % , which was not statistically different from placebo .
CONCLUSIONS	It can be concluded that subjects with moderate hypercholesterolemia and hypertension benefit more from lipid-lowering treatment with simvastatin than from blood pressure-lowering with beta blocker celiprolol .

###15470832
OBJECTIVE	To assess the impact of a programme regularly supplying free fluoride toothpaste to children on the prevalence and severity of fluorosis and other developmental defects of enamel .
METHODS	Randomised , controlled , parallel three-group clinical trial .
METHODS	Two groups received toothpaste containing either 440 or 1450 ppm F ; the third group received no intervention .
METHODS	Children were supplied with toothpaste and advice on its use from the age of 12 months until they were 5-6 years old .
METHODS	The participants were a sub sample of those involved in a study that considered the caries benefits of providing free fluoride toothpaste .
METHODS	They were eligible if they completed the main study , lived in four of the nine districts involved and attended schools with 6 or more eligible participants .
METHODS	Children from the north west of England consuming drinking water containing less than 0.1 ppm F were examined in primary schools .
METHODS	3731 children completed the main study .
METHODS	Of the 1833 children in the four selected districts , 927 were from schools with six or more participants .
METHODS	Digital images encompassing the upper and lower anterior sextants were taken of each child when they were 8-9 years old .
METHODS	Developmental defects of enamel and dental fluorosis ( TF index ) were recorded on upper central incisors from wet and dry images .
RESULTS	A total of 703 children were included in the data analysis .
RESULTS	In the 1450 ppm F ( n = 218 ) , 440 ppm F ( n = 226 ) and control ( n = 259 ) groups the prevalence of dental fluorosis ( TF > 0 ) was 17 % , 15 % and 12 % for the wet ( p > 0.05 ) and 26 % , 24 % and 25 % for the dry ( p > 0.05 ) photographs respectively .
RESULTS	The prevalence of TF scores 2 or 3 ( highest score ) was 5 % , 4 % and 2 % and for the wet ( p > 0.05 ) and 7 % , 4 % and 5 % for the dry ( p > 0.05 ) photographs respectively .
RESULTS	All subjects identified with TF score 3 were found in the group using the 1450 ppm F toothpaste ( 3 wet and 4 dry ) and there were statistically significant differences between the three groups for both wet ( p = 0.03 ) and dry photographs ( p < 0.01 ) .
RESULTS	However , the pairwise comparisons between the groups failed to attain statistical significance .
RESULTS	The highest prevalence and severity of demarcated opacities was seen in the control group and for the wet photographs the difference between the three groups attained statistical significance ( p = 0.04 ) .
RESULTS	For both the wet and dry photographs the prevalence of any enamel defects ( including fluorosis ) and large demarcated or TF score 3 was similar for the three groups ( p > 0.05 ) .
CONCLUSIONS	Previously it has been reported that only the provision of 1450 ppm F toothpaste provides anticaries benefits in a programme of this type .
CONCLUSIONS	This benefit is accompanied by a slight increase in prevalence of TF score 3 but not the overall prevalence of developmental defects of enamel .
CONCLUSIONS	Careful targeting and implementation of a programme of this type is required to maximise benefits and minimise risks of fluoride exposure .

###20307380
OBJECTIVE	To compare a ` bypass-surgery-first ' with a ` balloon-angioplasty-first ' revascularisation strategy in patients with severe limb ischaemia ( SLI ) due to infrainguinal disease requiring immediate/early revascularisation .
METHODS	A stratified randomised controlled trial .
METHODS	A Delphi consensus study of vascular surgeons ' and interventional radiologists ' views on SLI treatment was performed before the trial .
METHODS	Twenty-seven UK hospitals .
METHODS	Patients presenting with SLI as the result of infrainguinal atherosclerosis and who , in the opinion of the responsible consultant vascular surgeon and interventional radiologist , required and were suitable for both surgery and angioplasty .
METHODS	Patients were randomised to either ` bypass-surgery-first ' or ` balloon-angioplasty-first ' revascularisation strategies .
METHODS	The primary end point was amputation-free survival ( AFS ) ; secondary end points were overall survival ( OS ) , health-related quality of life ( HRQoL ) and cost-effective use of hospital resources .
RESULTS	AFS at 1 and 3 years was not significantly different for surgery and angioplasty .
RESULTS	Interim analysis showed that surgery was associated with significantly lower immediate failure , higher 30-day morbidity and lower 12-month reintervention rates than angioplasty ; 30-day mortality was similar .
RESULTS	Beyond 2 years from randomisation , hazard ratios ( HRs ) were significantly reduced for both AFS ( adjusted HR 0.37 ; 95 % CI 0.17 to 0.77 ; p = 0.008 ) and OS ( HR 0.34 ; 95 % CI 0.17 to 0.71 ; p = 0.004 ) for surgery relative to angioplasty .
RESULTS	By 2008 all but four patients had been followed for 3 years , some for over 7 years : 250 ( 56 % ) were dead , 168 ( 38 % ) were alive without amputation and 30 ( 7 % ) were alive with amputation .
RESULTS	Considering the follow-up period as a whole , AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation , bypass was associated with reduced HRs for AFS ( HR 0.85 ; 95 % CI 0.50 to 1.07 ; p = 0.108 ) and OS ( HR 0.61 ; 95 % CI 0.50 to 0.75 ; p = 0.009 ) , equating to an increase in restricted mean OS of 7.3 months ( p = 0.02 ) and AFS of 5.9 months ( p = 0.06 ) during the subsequent follow-up period .
RESULTS	Vein bypasses and angioplasties performed better than prosthetic bypasses .
RESULTS	HRQoL was non-significantly better in the surgery group ; amputation was associated with a significant reduction in HRQoL .
RESULTS	Over the first year , hospital costs for bypass were significantly higher ( difference 5420 pounds ; 95 % CI 1547 pounds to 9294 pounds ) than for angioplasty .
RESULTS	However , by 3 and at 7 years the differences in cost between the two strategies were no longer significant .
RESULTS	Patients randomised to surgery lived , on average , 29 days longer at an additional average cost of 2310 pounds .
RESULTS	A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery .
RESULTS	The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty .
CONCLUSIONS	The findings of our study suggest that in patients with SLI due to infrainguinal disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy .
CONCLUSIONS	Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost , and such patients are unlikely to enjoy the longer-term benefits of surgery .
CONCLUSIONS	By contrast , those patients expected to live beyond 2 years should usually be offered bypass surgery first , especially where a vein is available as a conduit .
CONCLUSIONS	Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass .
CONCLUSIONS	The failure rate of angioplasty in SLI is high ( c. 25 % ) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure .
CONCLUSIONS	The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation .
CONCLUSIONS	Further research is required to confirm or refute the BASIL findings and recommendations ; validate the BASIL survival prediction model in a separate cohort of patients with SLI ; examine the clinical and cost-effectiveness of new endovascular techniques and devices ; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects .
BACKGROUND	Current Controlled Trials ISRCTN45398889 .

###14726080
BACKGROUND	The present study was designed to evaluate the effectiveness of intrapleural 0.25 % bupivacaine delivered by intermittent infusions for post-thoracotomy pain relief .
METHODS	Forty patients undergoing elective lobectomy were randomly , but equally , placed into two groups .
METHODS	An intrapleural catheter was inserted under direct vision during surgery .
METHODS	Group I received intrapleural 40 mL of 0.25 % bupivacaine , group II was administered 40 mL of saline solution as a control group .
METHODS	Diclofenac sodium was administered as an additional analgesic , if required .
METHODS	Postoperative pain was evaluated using a visual analog scale ( VAS ) , and Prince Henry pain scale .
METHODS	Arterial oxygen saturation , heart rate , and systemic arterial pressures were monitored .
METHODS	All observations were recorded 5 , 10 , 15 , 20 , 25 , and 30 minutes after the injection , and thereafter at hourly intervals through the postoperative 24 hours .
RESULTS	The mean analgesia times were 5 hours and 2 hours in group I and group II , respectively .
RESULTS	Therefore , bupivacaine administrations were repeated every 6 hours in group I , and saline with additional analgesic were administered every 4 hours in group II .
RESULTS	The heart rate and arterial pressures did not show a significant difference .
RESULTS	While the additional analgesic requirement was 180 + / - 10 mg/d in group II , there was no need for additional analgesic administration in the group I patients .
RESULTS	Arterial oxygen was significantly higher in group I than in group II .
RESULTS	Arterial carbon dioxide tension of group II was significantly higher than that of group I.
RESULTS	While the postoperative atelectasis and pneumonia developed in four patients and one , respectively , in group II , no such complication was observed in group I.
CONCLUSIONS	The easy placement of an intrapleural catheter and better pain relief observed in the present study suggest that intermittent pleural infusion of 0.25 % bupivacaine has proven to be a safe and effective method for relief of post-thoracotomy pain .

###20962290
BACKGROUND	To date , there is no accepted clinical diagnostic test for Parkinson disease ( PD ) that is based on biochemical analysis of blood or CSF .
BACKGROUND	The discovery of mutations in the SNCA gene encoding - synuclein in familial parkinsonism and the accumulation of - synuclein in the PD brain suggested a critical role for this protein in PD etiology .
METHODS	We investigated total and - synuclein oligomers levels in CSF from patients clinically diagnosed with PD , progressive supranuclear palsy ( PSP ) , or Alzheimer disease ( AD ) , and age-matched controls , using ELISA developed in our laboratory .
RESULTS	The levels of - synuclein oligomers and oligomers/total -- synuclein ratio in CSF were higher in the PD group ( n = 32 ; p < 0.0001 , Mann-Whitney U test ) compared to the control group ( n = 28 ) .
RESULTS	The area under the receiver operating characteristic curve ( AUC ) indicated a sensitivity of 75.0 % and a specificity of 87.5 % , with an AUC of 0.859 for increased CSF - synuclein oligomers in clinically diagnosed PD cases .
RESULTS	However , when the CSF oligomers/total -- synuclein ratio was analyzed , it provided an even greater sensitivity of 89.3 % and specificity of 90.6 % , with an AUC of 0.948 .
RESULTS	In another cross-sectional pilot study , we confirmed that the levels of CSF - synuclein oligomers were higher in patients with PD ( n = 25 ) compared to patients with PSP ( n = 18 ; p < 0.05 ) or AD ( n = 35 ; p < 0.001 ) or control subjects ( n = 43 ; p < 0.05 ) .
CONCLUSIONS	Our results demonstrate that levels of - synuclein oligomers in CSF and the oligomers/total -- synuclein ratio can be useful biomarkers for diagnosis and early detection of PD .

###2212409
OBJECTIVE	to determine the effect of alternative regimens of nasal steroid administration on symptoms and quality of life .
METHODS	randomized , double-blind , parallel-group comparison .
METHODS	sixty ragweed-sensitive adults recruited from participants of previous studies and through media advertising .
METHODS	200 micrograms of aqueous beclomethasone diproprionate nasal spray , twice daily , from 1 week before until 1 week after the ragweed-pollen season ( regular ) or 100 micrograms of the spray , taken as required , up to 400 micrograms daily ; troublesome nasal symptoms were treated , in both groups , by increasing the daily dose to 800 micrograms until symptoms were controlled .
METHODS	If this treatment was insufficient , 120 mg of terfenadine , daily , was added .
RESULTS	One subject in the `` as required '' - treated group withdrew with uncontrolled nasal symptoms .
RESULTS	In the remaining subjects , sneezing , stuffy nose , and rhinorrhea , measured by a daily diary , were significantly better controlled in the regular-treated group ( p less than 0.025 ) .
RESULTS	Impairment of quality of life , including sleep disturbance , nonhay fever symptoms , practical problems , and uncomfortable emotions were greater in the as required-treated group ( p less than 0.001 ) .
RESULTS	Subjects in the regular-treated group required less additional terfenadine ( 0.27 tablets per subject versus 1.40 ; p = 0.022 ) .
RESULTS	Eye symptoms and eye-drop use were similar in the two treated groups .
CONCLUSIONS	In patients with seasonal allergic rhinitis , regular use of inhaled steroids results in fewer symptoms and better quality of life than when the spray is taken only as required .

###11106097
BACKGROUND	Alpha-interferons are the accepted therapy for patients infected with chronic hepatitis C virus ( HCV ) in China .
BACKGROUND	However , consensus interferon ( CIFN ) for HCV treatment is effective in patients with chronic hepatitis C from Western countries .
METHODS	This randomized , controlled trial was conducted to determine the safety and efficacy of CIFN at two doses , and to compare it with alpha-2a-interferon ( IFN-alpha-2a ) in Chinese patients with chronic HCV .
METHODS	Interferon-naive patients with chronic HCV infection ( n = 187 ) were randomly chosen to receive 15 microg CIFN or 9 microg or 3 MU IFN-alpha-2a subcutaneously , three times a week for 24 weeks , followed by a 24 week observation period .
METHODS	Efficacy was evaluated by the normalization of serum alanine aminotransferase ( ALT ) and the non-detectability disappearance of serum HCV-RNA by using reverse-transcription-polymerase chain reaction .
METHODS	The safety of CIFN was evaluated by recording the type and severity of adverse effects .
RESULTS	The combined ALT and HCV-RNA end-of-treatment and sustained responses were observed to be greater for treatment with 15 microg CIFN ( 59.0 % and 55.7 % , respectively ) compared to IFN alpha-2a ( 36.1 % and 39.3 % , respectively ; P = 0.01 for the end-of-treatment , P = 0.07 for the sustained response ) .
RESULTS	The combined ALT and HCV-RNA end-of-treatment and sustained responses for treatment with 9 microg CIFN ( both 49.2 % ) were higher than those for IFN-alpha-2a ( not statistically significant ) .
RESULTS	Data were analyzed by using a logistic-multiple-variate regression model , which indicated that the higher IFN dose ( 15 microg or 9 microg CIFN vs 3 MU IFN-alpha-2a ; P < 0.01 ) appeared to be associated with a better sustained response .
RESULTS	The type , frequency and severity of adverse effects were comparable across treatment groups .
CONCLUSIONS	Consensus interferon appears to be safe and effective at concentrations of 9 and 15 microg , but 15 microg CIFN may be more effective than 3 MU IFN-alpha-2a , without increased toxicity .

###22952179
BACKGROUND	Current evidence suggests a combined treatment of postpartum weight loss of diet and exercise .
BACKGROUND	However , to our knowledge , neither their separate and interactive effects nor long-term outcomes have been evaluated .
OBJECTIVE	We evaluated whether a 12-wk dietary behavior modification ( D ) treatment to decrease energy intake , physical exercise behavior modification ( E ) treatment to implement moderate aerobic exercise , or combined dietary and physical exercise behavior modification ( DE ) treatment compared with control ( usual care ) ( C ) reduces body weight in lactating women measured at the end of treatment and at a 1-y follow-up 9 mo after treatment termination .
METHODS	At 10-14 wk postpartum , 68 lactating Swedish women with a prepregnancy BMI ( in kg/m ) of 25-35 were randomly assigned to D , E , DE , or C groups .
METHODS	Measurements were made at baseline , after the intervention , and again at a 1-y follow-up 9 mo later .
METHODS	A 2 2 factorial approach was used to analyze main and interaction effects of treatments .
RESULTS	Weight changes after the intervention and 1-y follow-up were -8.3 4.2 and -10.2 5.7 kg , respectively , in the D group ; -2.4 3.2 and -2.7 5.9 kg , respectively , in the E group ; -6.9 3.0 and -7.3 6.3 kg , respectively , in the DE group ; and -0.8 3.0 and -0.9 6.6 kg , respectively , in the C group .
RESULTS	The main effects of D treatment , but not of E treatment , on weight were significant at both times ( P < 0.001 ) .
CONCLUSIONS	Dietary treatment provided clinically relevant weight loss in lactating postpartum women , which was sustained at 9 mo after treatment .
CONCLUSIONS	The combined treatment did not yield significant weight or body-composition changes beyond those of dietary treatment alone .

###1585957
BACKGROUND	Proposals to enroll Medicaid beneficiaries in health maintenance organizations ( HMOs ) have raised concerns that community-based mental health treatment programs would be adversely affected .
METHODS	In Hennepin County ( Minnesota ) 35 % of Medicaid beneficiaries were randomly assigned to prepaid plans .
METHODS	Random samples of individuals with severe mental illness with selected from the prepaid enrollees and from beneficiaries remaining with traditional Medicaid .
METHODS	The two groups were compared with respect to their use of community treatment programs and the write-off ( the proportion of patient charges for which payment was not received ) experienced by those programs for members of the study sample .
RESULTS	There was no strong evidence that Medicaid beneficiaries with severe mental illness who were randomly assigned to prepaid plans used community-based mental health treatment programs differently than did other Medicaid beneficiaries .
RESULTS	However , write-offs were consistently higher for enrollees in prepaid plans .
CONCLUSIONS	In the short run , the use of community-based mental health treatment programs need not be affected by enrollment of Medicaid beneficiaries in prepaid plans , providing that Medicaid program administrators take steps to minimize the disruption of ongoing treatment , offer beneficiaries a choice among prepaid plans , and encourage community treatment programs to contract with plans to serve beneficiaries .

###9865561
OBJECTIVE	Prior to endoscopic therapeutic procedures , no antibiotic prophylaxis is administered routinely .
OBJECTIVE	Because of the reported incidence of infectious complications , which may reach up to 10 % , a prospective study was undertaken to investigate the effects of a prophylactic dose of cefuroxime on the incidence of bacteremia and clinical signs of infection , but no significant effects could be demonstrated .
OBJECTIVE	In addition to this published work , blood and bile cultures obtained in this trial were also investigated , and the in-vitro susceptibility to several antibiotics was tested in order to recommend the appropriate substances .
METHODS	Ninety-nine consecutive patients ( 51 men , 48 women ; mean age 61.4 + / - 17 years ) with biliary obstruction who underwent an endoscopic retrograde cholangiopancreatography ( ERCP ) or percutaneous transhepatic cholangiography with drainage ( PTCD ) were included .
METHODS	Sequential blood cultures were taken before and up to 60 minutes after the endoscopic intervention .
METHODS	Bile cultures were obtained in 56 patients with biliary drainage .
METHODS	Aerobic and anaerobic cultures were prepared from all obtained specimens and the isolated organisms were identified .
METHODS	In the case of positive cultures , an in-vitro resistance test for 15 different antibiotics was performed .
RESULTS	The incidence of bacteremia was 11.1 % ( n = 11 ) , and 16 bacteria were isolated .
RESULTS	Twelve different microorganisms were detected , with Escherichia coli found in four cases .
RESULTS	From 41 positive out of 56 prepared bile cultures ( 73.2 % ) , 91 isolates were found with 25 different species .
RESULTS	A single agent was detected in eight cases ( 19.5 % ) , while a mixed growth , with pathogens ranging from two to six species , was found in 33 cases ( 80.5 % ) .
RESULTS	The seven most frequently isolated germs were E. coli and Enterococcus ( each n = 19 ) , Klebsiella ( n = 10 ) , Streptococcus viridans ( n = 9 ) , Staphylococcus epidermidis ( n = 5 ) , Morganella morganii ( n = 4 ) , and Bacteroides fragilis ( n = 3 ) , representing 76 % of all agents .
RESULTS	Examination for fungal infection revealed positive cultures of Candida albicans in 16.1 % of bile cultures ( nine of 56 ) .
RESULTS	Interestingly , the use of proton-pump inhibitors ( PPIs ) , with a consequent rise in the gastric pH value , led to an increase in the rate of bacteremia to 26.2 % ( five of 19 ) compared to the other patients not on PPIs ( n = 80 ) , who developed bacteremia in only six cases ( 7.5 % ; p = 0.02 ) .
RESULTS	In-vitro testing of different antibiotics was carried out in 73 isolates .
RESULTS	Imipenem showed the best antimicrobial activity ( 98.4 % ) , followed by trimethoprim and sulfamethoxazole ( 90 % ) , amoxicillin plus clavulanic acid ( 87.3 % ) , vancomycin ( 82.4 % ) , and ofloxacin ( 76.9 % ) .
CONCLUSIONS	Escherichia coli was found to be the pathogen most frequently detected in blood and bile following endoscopic interventions in the biliary tract .
CONCLUSIONS	Enterococci , Klebsiella and Streptococcus viridans were found in bile cultures with an incidence exceeding 10 % .
CONCLUSIONS	In view of the in-vitro test results , possible side effects , and contraindications , amoxicillin plus beta-lactamase inhibitors or quinolones are considered to be suitable antibiotics for the prophylaxis of biliary infections .

###12014163
OBJECTIVE	The purpose of this study was to assess the effects of topical fluoride agents on enamel erosion in vitro .
METHODS	Ten premolars extracted for orthodontic purposes were sectioned buccolingually and then longitudinally into two parts , so that four specimens were obtained from each tooth .
METHODS	The specimens were randomly assigned to one of four groups .
METHODS	The following topical fluoride agents were applied to the specimens : 1 % titanium tetrafluoride ( 0.32 MF ) for 1 minute ; Duraphat ( 2.26 % F ) and Elmex ( 1.25 % F ) for 4 minutes .
METHODS	In the control group , no solution was applied .
METHODS	The specimens were treated with an artificial caries solution for 4 , 8 , 12 , and 16 days .
METHODS	Calcium ( Ca + + ) concentration was determined by an atomic absorbtion spectrophotometer , while fluoride ( F - ) concentration was determined with an ion-selective electrode .
METHODS	One-way analysis of variance tests were performed on cumulative concentrations of calcium and fluoride at days 4 , 8 , 12 , and 16 .
RESULTS	Specimens treated with titanium tetrafluoride lost significantly less calcium than did specimens in the other two test groups at all time periods .
RESULTS	Titanium tetrafluoride-treated specimens released significantly less fluoride than did Duraphat - or Elmex-treated specimens at day 16 .
CONCLUSIONS	Titanium tetrafluoride was found to be more effective than the other fluoride agents in preventing artificial enamel lesion formation .

###21546203
OBJECTIVE	To evaluate the impact of a socio-cognitive intervention associated with a pedometer-based program on physical activity , cardiovascular risk factors and self-efficacy expectation during one year following an acute coronary syndrome .
METHODS	Sixty-five subjects were randomized during hospitalization in an experimental or a usual care group .
METHODS	Average steps/day was measured every 3 months until one year following discharge .
METHODS	Other dependent variables were measured at baseline , 6 and 12 months follow-up .
RESULTS	There were 32 patients in the experimental group and 33 patients in the usual care group .
RESULTS	Group characteristics were comparable .
RESULTS	At baseline , averages steps/day were similar between groups ( 58453246 vs. 60973055 steps/day ; p = 0.812 ) .
RESULTS	At 3-month follow-up , both groups increased their averages steps/day ( p < 0.05 ) .
RESULTS	This increase was higher in the experimental group ( 3388844 vs. 1934889 steps/day ; p < 0.001 ) .
RESULTS	At 12-month , interaction effects ( grouptime ) in physical activity and waist circumference were different between groups ( p < 0.05 ) , whereas self-efficacy expectation increased in both groups similarly ( p < 0.05 ) .
CONCLUSIONS	The intervention is useful to improve average steps/day and waist circumference during the first year following an acute coronary syndrome .
CONCLUSIONS	This study supports development of the home-based cardiac rehabilitation program using socio-cognitive intervention associated with a pedometer after an acute coronary syndrome .

###19335655
OBJECTIVE	Hazardous alcohol use is a leading cause of death among adolescents and young adults world-wide , yet few effective prevention interventions exist .
OBJECTIVE	This study was the first to examine a computerized harm minimization intervention to reduce alcohol misuse and related harms in adolescents .
METHODS	Cluster randomized controlled trial of a six-session curriculum-integrated harm minimization prevention program .
METHODS	The intervention was delivered by computer in the form of a teenage drama , which provided education through alcohol-related scenarios to which young people could relate .
METHODS	Schools in Australia .
METHODS	A total of 1466 year 8 students ( 13 years ) from 16 high schools in Australia were allocated randomly to a computerized prevention program ( n = 611 , eight schools ) or usual classes ( n = 855 , eight schools ) .
METHODS	Change in knowledge , alcohol use , alcohol-related harms and alcohol expectancies .
RESULTS	A computerized prevention program was more effective than usual classes in increasing alcohol-related knowledge of facts that would inform safer drinking choices and decreasing the positive social expectations which students believed alcohol may afford .
RESULTS	For females it was effective in decreasing average alcohol consumption , alcohol-related harms and the frequency of drinking to excess ( more than four standard drinks ; 10 g ethanol ) .
RESULTS	For males the behavioural effects were not significant .
CONCLUSIONS	A harm minimization approach is effective in educating young people about alcohol-related risks and is effective in reducing risky drinking and harms among girls .
CONCLUSIONS	Reduction of problems among boys remains a challenge .

###10561618
OBJECTIVE	Our purpose was to compare the efficacy , safety , and adverse effects of intra-amniotically administered ( 15S ) -15 - methyl-prostaglandin F ( 2alpha ) and intravaginally administered misoprostol for second-trimester uterine evacuation .
METHODS	Fifty-one patients were randomly assigned to receive either a single 2.5-mg intra-amniotic injection of ( 15S ) -15 - methyl-prostaglandin F ( 2 ) ( alpha ) ( n = 26 ) or two 200-microg intravaginal doses of misoprostol ( n = 25 ) at 12-hour intervals .
METHODS	The primary outcome measured was evacuation of the uterus within 24 hours .
RESULTS	The mean time from initiation of termination to uterine evacuation was less in the prostaglandin group than in the misoprostol group ( 17.5 + / - 8.6 hours vs 22.3 + / - 12.5 hours ) , but this was not statistically significant ( P > .05 ) .
RESULTS	The rate of successful fetal evacuation at 24 hours was significantly higher in the prostaglandin group than in the misoprostol group ( 88 % vs 60 % , P = .02 ) .
RESULTS	The complete-abortion rate and the incidence of adverse effects were similar in both groups .
CONCLUSIONS	The use of an intra-amniotic injection of ( 15S ) -15 - methyl-prostaglandin F ( 2alpha ) for midtrimester pregnancy termination is safe and is associated with a greater number of successful uterine evacuations within 24 hours , without an increase in adverse effects , than intravaginal administration of misoprostol .

###22897123
OBJECTIVE	This study presents data from a randomized outcome study comparing mentalization-based and supportive psychotherapy for patients with borderline personality disorder ( BPD ) .
METHODS	Eighty-five SCID-II diagnosed borderline patients were randomized to either i ) 2 years of intensive ( twice weekly ) combined ( individual and group ) , mentalization-based psychotherapy ( MBT ) or ii ) 2 years of less-intensive ( biweekly ) supportive group therapy .
METHODS	Treatment outcome was assessed using a battery of self-report questionnaires , SCID-II interviews and therapist-rated global assessment of functioning ( GAF ) .
RESULTS	Fifty-eight patients completed 2 years of treatment .
RESULTS	Significant changes in both treatment groups were identified for several outcome measures , including self-reported measures of general functioning , depression , social functioning and number of diagnostic criteria met for BPD , as outlined by the SCID-II interview .
RESULTS	General linear modelling was used to compare treatment outcome in the two groups .
RESULTS	Only GAF showed a significantly higher outcome in the MBT group .
RESULTS	A trend was found for a higher rate of recovery from BPD in the MBT group .
RESULTS	Pre-post effect sizes were high ( 0.5-2 .1 ) and for the most part highly significant in both groups .
CONCLUSIONS	The study indicates that both MBT and supportive treatment are highly effective in treating BPD when conducted by a well-trained and experienced psychodynamic staff in a well-organized clinic .

###16481919
OBJECTIVE	The objective of this study was to compare intracoronary attenuation on 16-row multislice computed tomography ( 16-MSCT ) coronary angiography using 2 contrast materials ( CM ) with high iodine concentration .
METHODS	Forty consecutive patients ( 29 male , 11 female ; mean age , 61 + / -11 years ) with suspected coronary artery disease were randomized to 2 groups to receive 100 mL of either iopromide 370 ( group 1 : Ultravist 370 , 370 mg iodine/mL ; Schering AG , Berlin , Germany ) or iomeprol 400 ( group 2 : Iomeron 400 , 400 mg iodine/mL ; Bracco Imaging SpA , Milan , Italy ) .
METHODS	Both CM were administered at a rate of 4 mL/s .
METHODS	All patients underwent 16-MSCT coronary angiography ( Sensation 16 ; Siemens , Germany ) with collimation 16 x 0.75 mm and rotation time 375 ms. The attenuation in Hounsfield units ( HU ) achieved after each CM was determined at regions of interest ( ROIs ) placed at the origin of coronary arteries and on the ascending aorta , descending aorta , and pulmonary artery .
METHODS	Differences in mean attenuation in the coronary arteries and on the ascending aorta , descending aorta , and pulmonary artery were evaluated using Student t test .
RESULTS	The mean attenuation achieved at each anatomic site was consistently greater after iomeprol 400 than after iopromide 370 .
RESULTS	At the origin of coronary arteries , the mean attenuation after iomeprol 400 ( 340 + / -53 HU ) was greater ( P < 0.05 ) than that after iopromide 370 ( 313 + / - 42 HU ) .
RESULTS	Similar findings were noted for the mean attenuation in the ascending aorta , descending aorta , and pulmonary artery .
CONCLUSIONS	The intravenous administration of iomeprol 400 provides higher attenuation of the coronary arteries and of the great arteries of the thorax as compared with iopromide 370 using the same injection parameters .

###24615211
OBJECTIVE	To investigate whether the neural representations underlying alternating two acupoint combinations ( ACs ) are the same or not .
METHODS	In this functional magnetic resonance imaging study , two sets of analgesia ACs were utilized , including Waiguan ( TE5 ) and Qiuxu ( GB40 ) for Group A , and Neiguan ( PC6 ) and Taichong ( LR3 ) for Group B , which are the most commonly adopted in clinical treatment .
METHODS	Each group had 20 healthy subjects .
METHODS	An experimental design was proposed , which consisted of a pre-needling resting phase , a needling phase and a post-needling resting phase .
METHODS	This paradigm optimally mimics the clinical protocol as well as focuses on both the stimulation and the resting periods .
METHODS	The results were subjected to general linear model analysis , conjunction analysis and the functional connectivity analysis .
RESULTS	The rostral anterior cingulated cortex was engaged in the initiative period of the acupuncture effect in both groups , and it was chosen as the seed region for the functional connectivity analysis for the following resting period .
RESULTS	The results showed that several shared brain regions were involved in both groups , in particular the insula , amygdala and hypothalamus .
RESULTS	Moreover , significant differences were located at the posterior cingulated cortex as revealed by a two sample - test ( P < 0.05 , corrected ) .
RESULTS	Other regions showed no significant differences .
RESULTS	This finding was further supported by the spatial correlation analysis that the two groups were significantly correlated ( r = 0.51 , P < 0.01 ) .
CONCLUSIONS	This preliminary research helps us understand the neurophysiological mechanisms of acupuncture when following clinical guidelines on ACs , as well as provides an important opportunity to develop better treatment strategies for reducing , or even preventing pain .

###15895715
OBJECTIVE	Mucopolysaccharidosis VI ( Maroteaux-Lamy syndrome ) is a lysosomal storage disease caused by a deficiency of the enzyme-N-acetylgalactosamine 4-sulphatase ( ASB ) .
OBJECTIVE	Enzyme replacement therapy with recombinant human ASB ( rhASB ) has been studied in a randomized , double-blind , two-dose ( 0.2 and 1.0 mg/kg/week ) phase I/II study ( n = 7 ) followed by an open-label single dose ( 1.0 mg/kg/week ) extension study .
OBJECTIVE	We report the pharmacokinetic profile of rhASB and the impact of antibody development .
METHODS	Pharmacokinetic analysis was performed at weeks 1 , 2 , 12 , 24 , 83 , 84 and 96 .
METHODS	Infusions were administered over 4 hours using a ramp-up protocol .
METHODS	Plasma ASB and rhASB antibody concentrations and urine glycosaminoglycan ( GAG ) concentrations were determined .
RESULTS	The area under the plasma concentration-time curve ( AUC ( 0-t ) ) for the high-dose group increased from week 1 to week 2 , but remained unchanged at weeks 12 and 24 .
RESULTS	A large difference in mean AUC ( 0-t ) was observed between the low - and high-dose groups .
RESULTS	Pharmacokinetic results at weeks 83 , 84 and 96 were similar to those at week 24 .
RESULTS	Six patients developed antibodies to rhASB .
RESULTS	One patient developed high antibody levels in combination with a high ASB concentration , while a second patient also developed high antibody levels with undetectable ASB concentrations .
RESULTS	Antibodies from the second patient blocked detection of ASB .
RESULTS	By week 72 , antibody levels had decreased in all patients .
RESULTS	The high-dose rhASB produced a more rapid and greater percentage reduction in urinary GAG concentrations than the lower dose ( 70 % versus 55 % at 24 weeks ) .
RESULTS	Antibody levels did not appear to influence urinary GAG concentrations .
CONCLUSIONS	Pharmacokinetic parameters appear to be independent of the duration of treatment and are not linear between the 0.2 and 1.0 mg/kg/week doses .
CONCLUSIONS	Antibodies to rhASB develop in most patients , but their concentration decreases over time .
CONCLUSIONS	Antibody formation may influence pharmacokinetic parameters during the early phases of treatment , although it appears to have limited impact on biochemical efficacy .

###17408407
BACKGROUND	Orthopedic surgery , especially total knee and total hip arthroplasty , is considered a risk factor for peri-operative venous thromboembolism .
OBJECTIVE	This study evaluates how accelerated inflammatogenic cellular interactions and the subsequent production of tissue factor and CD40 ligand play an important role in the pathogenesis of venous thromboembolism .
METHODS	Twenty-four patients undergoing total knee arthroplasty were randomly assigned to groups with ( Ti ; n = 12 ) and without ( Tn ; n = 12 ) pneumatic tourniquet inflation .
RESULTS	Numbers of leukocyte-platelet aggregates , especially those comprising monocytes-platelets in central venous blood from the Ti group , were increased during the peri-operative period ( P < 0.01 ) , and returned to the baseline level at 24 h after starting surgery .
RESULTS	Levels of PAC-1 , P-selectin , CD40 ligand , tissue factor , Mac-1 expression on monocytes including monocyte-platelet aggregates , and the number of microparticles including those of endothelial cell origin were noticeably increased in central venous blood from the Ti group ( P < 0.01 ) .
RESULTS	Whole blood coagulability was also obviously increased in central venous blood from the Ti group ( P < 0.01 ) .
RESULTS	Furthermore , the concentrations of venous plasma tissue factor antigen , CD40 ligand , platelet factor 4 , beta-thromboglobulin , the soluble fibrin monomer complex and prothrombin fragment 1 +2 were also increased ( P < 0.05 ) .
CONCLUSIONS	This study showed that platelet , leukocyte and endothelium activities as well as their interactions are enhanced during the peri-operative period of total knee arthroplasty , particularly in venous blood from the lower half of the body , which consequently augments blood coagulability .
CONCLUSIONS	Further , tourniquet inflation during surgery exaggerates these responses .

###23866474
OBJECTIVE	To evaluate the efficacy of preoperative oral clonidine ( 5 g/kg ) in preventing ocular hypertension in the early period after cataract surgery with posterior chamber intraocular lens implantation under general anaesthesia .
METHODS	This was a randomized double-blind clinical trial comprising of 62 eyes in 62 patients with senile cataract without using any viscoelastics .
METHODS	They were randomly assigned into two groups for preoperative oral clonidine ( 5 g/kg ) and placebo .
METHODS	Intraocular pressure ( IOP ) was measured 6,12 and 24 hours postoperatively .
RESULTS	Mean differences of lOPs at 6 and 12 hours after surgery were significantly lower in clonidine group [ +0.41 4.55 ( p = 0.612 ) , 0.06 3.62 ( p = 0.922 ) ] than placebo group [ 5.77 4.25 ( p = < 0.001 ) , 4.70 3.19 p < 0.001 ) ] but was more than preoperative intraocular pressures in both .
RESULTS	There was no statistically significant difference between the mean IOP 24hours post operatively in the two groups .
RESULTS	But compared to preoperative IOP less increase in mean IOP was seen in clonidine group when compared to placebo group .
CONCLUSIONS	A single dose of oral clonidine ( 5 g/kg ) preoperatively can produce a significant IOP-lowering effect in early period after cataract surgery , specially in the first 12 hours .

###19304046
OBJECTIVE	This study was undertaken with the null hypothesis that in patients , fully denate or with 1 or 2 teeth missing and older than 25 years , mastication does not affect late mandibular fracture after surgical removal of impacted third molars ( M3s ) associated with no gross pathology .
METHODS	Five hundred sixty patients , fully dentate or with 1 or 2 teeth missing and older than 25 years who had no gross pathology associated with their impacted lower M3s , were recruited in this study .
METHODS	They were operated on under local anesthesia using a standard technique and randomly assigned into 2 groups for nonroutine ( NR group ) and routine ( R group ) postoperative instructions .
METHODS	In the NR group , patients were postoperatively educated in the possibility of mandibular fracture and were given an emphasis on the necessity of limiting mastication to a soft diet for 4 weeks .
METHODS	In the R group , patients were given no such education or emphasis .
METHODS	Patients were followed up for 2 months , and data concerning patients ' age and gender ; tooth position , angulation , and depth ; date and site of surgery ; and occurrence of late mandibular fracture were recorded and statistically analyzed .
METHODS	A value of P less than .05 was considered statistically significant .
RESULTS	In no patient group was there a late mandibular fracture recorded .
RESULTS	All patients completed the follow-up period , and most of the R group patients had normal eating habits 10 to 14 days after surgery .
RESULTS	In no patient group was there a statistically significant difference in relation to gender ( P = .735 ) , site of surgery ( P = .552 ) , class horizontal space available ( P = .427 ) , class highest portion of the M3 crown ( P = .424 ) , angulations of the teeth ( P = .925 ) , and severity of impaction ( P = .445 ) .
CONCLUSIONS	In patients , fully dentate or with 1 or 2 teeth missing and older than 25 years who have no jawbone atrophy and no systemic problems that may impair bone strength , mastication seems not to affect late mandibular fracture after surgical removal of impacted M3s associated with no gross pathology .
CONCLUSIONS	The remote possible risk of the late fracture shown in our patients indicates the need for no special precautions .

###8414414
OBJECTIVE	Optimal radiation therapy for uveal melanoma is uncertain , and the relative efficacies of radioactive plaques and charged particles are unclear .
METHODS	The authors prospectively studied helium-ion irradiation and iodine 125 ( 125I ) brachytherapy in a randomized , dynamically balanced trial .
METHODS	Of the 184 patients who met the eligibility criteria , 86 were treated with helium ions and 98 with 125I brachytherapy .
RESULTS	No patients with uveal melanoma had a history of systemic malignancy .
RESULTS	Tumors were less than 15 mm in maximum diameter and less than 10 mm in thickness .
RESULTS	A minimum tumor dose of 70 GyE was delivered to the tumor apex .
RESULTS	There was a significantly higher local recurrence rate after 125I brachytherapy than after helium-ion irradiation .
RESULTS	Enucleations occurred more frequently after brachytherapy ( relative risk = 1.99 ; 95 % confidence interval , 0.78-5 .78 ) .
RESULTS	More anterior segment complications occurred after helium-ion irradiation .
RESULTS	To date , there has been no measurable impact on survival .
CONCLUSIONS	Most uveal melanomas can be managed with radiation with retention of the eye .
CONCLUSIONS	There was better tumor control with helium-ion irradiation ; however , there were more anterior segment complications .

###17339385
OBJECTIVE	In a previous multicenter , randomized trial , elective use of high-frequency oscillatory ventilation was compared with the use of conventional ventilation in the management of respiratory distress syndrome in preterm infants < 30 weeks .
OBJECTIVE	No difference in terms of respiratory outcome was observed , but concerns were raised about an increased rate of severe intraventricular hemorrhage in the high-frequency ventilation group .
OBJECTIVE	To evaluate outcome , a follow-up study was conducted until a corrected age of 2 years .
OBJECTIVE	We report the results concerning neuromotor outcome .
METHODS	Outcome was able to be evaluated in 192 of the 212 infants who survived until discharge from the neonatal unit : 97 of 105 infants of the high-frequency group and 95 of 104 infants of the conventional ventilation group .
RESULTS	In the infants reviewed , mean birth weight and gestational age were similar in the 2 ventilation groups .
RESULTS	As in the overall study population , the following differences were observed between the high-frequency ventilation group and the conventional ventilation group : lower 5-minute Apgar score , fewer surfactant instillations , and a higher incidence of severe intraventricular hemorrhage .
RESULTS	At a corrected age of 2 years , 93 of the 97 infants of the high-frequency group and 79 of the 95 infants of the conventional ventilation group did not present any neuromotor disability , whereas 4 infants of the high-frequency group and 16 infants of the conventional ventilation group had cerebral palsy .
CONCLUSIONS	Contrary to our initial concern about the increased rate of severe intraventricular hemorrhage in the high-frequency ventilation group , these data suggest that early use of high-frequency ventilation , compared with conventional ventilation , may be associated with a better neuromotor outcome .
CONCLUSIONS	Because of the small number of patients studied and the absence of any explanation for this finding , we can conclude only that high-frequency oscillatory ventilation is not associated with a poorer neuromotor outcome .

###15924803
OBJECTIVE	The mean level of serum cholesterol in Chinese population with coronary heart disease ( CHD ) is relatively lower compared to that of western population .
OBJECTIVE	Our study aimed to evaluate whether lipid-lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in Chinese CHD patients .
METHODS	This study was designed as a random , double-blinded , placebo controlled clinical trial in 66 centers in China and was conducted from may , 1996 to December , 2003.4870 CHD patients ( serum cholesterol level 4.40 - 6.47 mmol/L , age 18 - 75 years , with definite myocardial infarction history ) were selected and treated with capsule Xuezhikang ( 0.6 g Bid ) or placebo in addition to conventional therapy ( control group ) .
METHODS	The mean follow-up period was four years .
METHODS	The primary end-points were nonfatal myocardial infarction and deaths from CHD .
RESULTS	It has been shown at the end of the trial : ( 1 ) The incidence of the primary end-points were 5.72 % in Xuezhikang treatment group and 10.41 % in control group , with a reduction of relative risk by 45.1 % for treatment group ( P = 0.0000 ) .
RESULTS	Among the primary end points , the incidence of deaths from CHD was 3.79 % in the treatment group and 5.49 % in the control group , with a reduction of relative risk by 31.0 % in treatment group ( P < 0.0048 ) ; ( 2 ) The incidence of nonfatal myocardial infarction reduced by 60.8 % in treatment group compared to control group ( 1.93 % vs 4.92 % , P < 0.0000 ) ; ( 3 ) The incidence of the secondary end-points ( stroke , tumor , PCI/CABG ) also decreased by 31.1 % in treatment group compared to control group ( 6.92 % vs 10.04 % P < 0.0004 ) .
RESULTS	Among the secondary end points , the demand for PCI/CABG was 3.01 % in the treatment group and 4.51 % in the control group , with a reduction of relative risk by 33.3 % in treatment group ( P = 0.097 ) ; ( 4 ) The total mortality was lower in treatment group than control group , with a reduction of relative risk by 33.0 % in treatment group ( 5.19 % vs 7.74 % P = 0.0003 ) .
RESULTS	There were no significant differences in side effects and abnormal laboratory references between the two groups .
CONCLUSIONS	Compared to placebo , Xuezhikang can significantly decrease the incidence of nonfatal myocardial infarction and deaths from CHD .
CONCLUSIONS	It can also reduce significantly the demand for PCI/CABG , the total mortality and the deaths from tumor .

###18155052
OBJECTIVE	Experimental nerve block in animals inhibits the inflammatory response .
OBJECTIVE	The purpose of this study was to determine to what extent a 48-hour local anesthetic block of all afferent and efferent nerve fibers of the knee area has an impact on postoperative inflammatory response .
METHODS	Twelve patients scheduled for primary total knee arthroplasty received spinal anesthesia , and then were randomly allocated to either patient-controlled analgesia with morphine ( n = 6 ) or a combination of continuous lumbar plexus and sciatic nerve blocks ( continuous peripheral nerve block ; CPNB ) with ropivacaine 0.2 % for 48 hours .
METHODS	Blood samples were collected before surgery and at 3 , 8 , 24 , and 48 hours after surgical incision to measure plasma glucose , serum insulin and cortisol , C-reactive protein , interleukin-6 , and leukocyte count .
METHODS	Pain visual analog scale at rest and on knee flexion were recorded and complications classified .
RESULTS	Visual analog scale was lower in the CPNB group at rest and on knee flexion on postoperative days 1 and 2 ( P < .05 ) .
RESULTS	There were no differences in circulating levels of glucose , insulin , and cortisol .
RESULTS	C-reactive protein and leukocyte count were lower in the CPNB group ( P < .05 ) .
RESULTS	There was a positive correlation between the peak leukocyte count and the inflammatory markers ( P < .03 ) .
RESULTS	Three patients in the patient-controlled analgesia group and one in the CPNB group had complications requiring conservative management .
CONCLUSIONS	Continuous lumbar plexus and sciatic nerve blocks with ropivacaine contribute to the attenuation of the postoperative inflammatory response .

###15274379
BACKGROUND	Preoperative transarterial chemoembolization is not routinely recommended before hepatectomy for resectable hepatocellular carcinoma .
BACKGROUND	This study evaluated the effect of preoperative whole-liver chemolipiodolization .
METHODS	A retrospective comparison of background characteristics , operative results and long-term outcome was performed between 36 patients with chemolipiodolization confined to the tumor ( selective group ) and 23 patients with chemolipiodolization also involving the noncancerous liver ( whole-liver group ) .
RESULTS	There were no serious side-effects in either group and the operative outcome did not differ between the two groups .
RESULTS	Tumor diameter was significantly greater in the selective group , but other pathological characteristics were comparable .
RESULTS	The 5-year disease-free and overall survival rates for the selective and whole-liver groups were 11.9 % and 33.0 % ( p = 0.0191 ) and 44.9 % and 73.2 % ( p = 0.0121 ) , respectively .
CONCLUSIONS	These results indicate that preoperative whole-liver chemolipiodolization reduces postoperative recurrence and prolongs survival in patients undergoing resection of hepatocellular carcinoma .

###16527699
OBJECTIVE	High-resolution colonoscopy with chromoscopy ( HRC ) is a technique designed to improve the detection of colonic neoplasias .
OBJECTIVE	We prospectively compared standard colonoscopy ( SC ) and HRC in a randomized multicenter trial .
METHODS	Patients ( n = 203 ; age , 58 + / - 10 years ; sex ratio , 1 ) were recruited according to the following criteria : ( 1 ) a history of either familial or personal colonic neoplasia or ( 2 ) alarm symptoms after the age of 60 years .
METHODS	After randomization , an SC was performed in 100 patients ( resolution , < or = 410,000 pixels ) and a HRC in 103 patients ( Fujinon EC485ZW , 850,000 pixels ) .
METHODS	In the HRC group , each colonic segment was examined before and after spraying with indigo carmine 0.4 % .
RESULTS	Two hundred seventy-six polyps were detected in 198 patients .
RESULTS	One hundred sixty of them were hyperplastic polyps , 116 were adenomas , and 2 were carcinomas .
RESULTS	The numbers of hyperplastic polyps and purely flat adenomas were significantly higher in the HRC group than in the SC group ( 1.1 + / - 1.6 vs 0.5 + / - 1.4 and 0.22 + / - 0.68 vs 0.07 + / - 0.29 , respectively ; P = .01 and P = .04 ) , but there was no significant difference in the total number of adenomas per patient ( primary end point ) detected between the HRC and the SC groups ( 0.6 + / - 1.0 vs 0.5 + / - 0.9 , respectively ) .
CONCLUSIONS	Although HRC improves detection of purely flat adenomas and hyperplastic polyps , the overall detection of colonic adenomas in a population at increased risk of neoplasia is not significantly improved .
CONCLUSIONS	These findings do not support the routine use of HRC in clinical practice .

###14529670
OBJECTIVE	While the importance of the sequence of administration of cisplatin and paclitaxel on the degree of observed neutropenia has been documented , there is limited information available in the oncology literature to determine whether there exists sequence-dependent toxicity for the combination of carboplatin plus paclitaxel .
METHODS	Patients with advanced gynecologic malignancies were randomized to receive either carboplatin ( AUC 6 ) , followed by paclitaxel ( 175 mg/m ( 2 ) over 3 h ) ( C-P ) , or the same doses of the agents delivered in the opposite sequence ( P-C ) .
METHODS	The primary endpoint was the degree of neutropenia experienced during the initial treatment course .
RESULTS	A total of 40 patients ( median age : 63 ) entered this trial , of whom 27 had complete pretreatment and nadir counts available for course 1 and 24 for both course 1 and course 2 .
RESULTS	By random chance , patients initially receiving P-C began therapy with a higher baseline ANC than those treated with C-P .
RESULTS	During course 1 , the P-C population was noted to have a greater reduction , from baseline , in ANC ( P = 0.02 ) , but no difference in absolute nadir counts ( ignoring the baseline value ) ( P = 0.64 ) .
RESULTS	There was no difference between P-C , followed by C-P , versus C-P , followed by P-C in the severity of neutropenia experienced during course 2 ( P = 0.38 ) .
CONCLUSIONS	The sequence of carboplatin/paclitaxel administration does not exert a significant influence on the level of observed neutropenia .
CONCLUSIONS	This finding leads to the suggestion that the sequence of drug delivery can be modified , as necessary , to satisfy unique requirements of individual patients and to establish the optimal drug delivery strategy of an innovative investigational treatment regimen .

###16401473
OBJECTIVE	In patients with stones in their bile ducts and gallbladders , cholecystectomy is generally recommended after endoscopic sphincterotomy and clearance of bile duct stones .
OBJECTIVE	However , only approximately 10 % of patients with gallbladders left in situ will return with further biliary complications .
OBJECTIVE	Expectant management is alternately advocated .
OBJECTIVE	In this study , we compared the treatment strategies of laparoscopic cholecystectomy and gallbladders left in situ .
METHODS	We randomized patients ( > 60 years of age ) after endoscopic sphincterotomy and clearance of their bile duct stones to receive early laparoscopic cholecystectomy or expectant management .
METHODS	The primary outcome was further biliary complications .
METHODS	Other outcome measures included adverse events after cholecystectomy and late deaths from all causes .
RESULTS	One hundred seventy-eight patients entered into the trial ( 89 in each group ) ; 82 of 89 patients who were randomized to receive laparoscopic cholecystectomy underwent the procedure .
RESULTS	Conversion to open surgery was needed in 16 of 82 patients ( 20 % ) .
RESULTS	Postoperative complications occurred in 8 patients ( 9 % ) .
RESULTS	Analysis was by intention to treat .
RESULTS	With a median follow-up of approximately 5 years , 6 patients ( 7 % ) in the cholecystectomy group returned with further biliary events ( cholangitis , n = 5 ; biliary pain , n = 1 ) .
RESULTS	Among those with gallbladders in situ , 21 ( 24 % ) returned with further biliary events ( cholangitis , n = 13 ; acute cholecystitis , n = 5 ; biliary pain , n = 2 ; and jaundice , n = 1 ; log rank , P = .001 ) .
RESULTS	Late deaths were similar between groups ( cholecystectomy , n = 19 ; gallbladder in situ , n = 11 ; P = .12 ) .
CONCLUSIONS	In the Chinese , cholecystectomy after endoscopic treatment of bile duct stones reduces recurrent biliary events and should be recommended .

###10685653
OBJECTIVE	The modest activity of chemotherapy and biologic agents in the treatment of advanced metastatic melanoma has prompted investigators to consider combinations of chemotherapy and biologic agents ( i.e. , biochemotherapy ) as a way of improving response rates and survival .
OBJECTIVE	Although biochemotherapy has generated a great deal of interest over the last several years , and these regimens have produced high response rates in single-institution phase II trials , they have yet to demonstrate a significant survival benefit in randomized trials compared with either chemotherapy or biotherapy alone .
METHODS	The available literature regarding the clinical experience with single - and multiagent chemotherapy , immunotherapy , and biochemotherapy was reviewed .
RESULTS	Treatment of metastatic melanoma with either single-agent or combination chemotherapy regimens is clearly suboptimal ; the majority of responses are partial and of short duration .
RESULTS	In contrast , interleukin ( IL ) -2 produces long-term durable complete remission in a subset of patients .
RESULTS	Over 1,000 patients have been treated with IL-2-based biochemotherapy regimens in single-institution phase II trials , and response rates have ranged from 40 % to 60 % .
RESULTS	Most encouraging have been the durable responses observed in 10 % to 20 % of patients in most of these trials .
RESULTS	Large databases , including two meta-analyses , have confirmed the substantial improvement in response rate associated with biochemotherapy regimens that include both IL-2 and interferon alfa ( IFN-alpha ) compared with chemotherapy or biotherapy alone .
RESULTS	Biochemotherapy is currently being evaluated in randomized controlled trials to determine if this treatment strategy can provide a survival benefit compared with current standard treatments .
RESULTS	A pilot study at Beth Israel Deaconess Medical Center has demonstrated the feasibility of administering a modification of a concurrent biochemotherapy regimen , initially described by Legha et al , consisting of cisplatin , vinblastine , and dacarbazine ( CVD ) plus IL-2 and IFN-alpha in the cooperative group setting .
CONCLUSIONS	These studies provided the rationale for intergroup trial E-3695 , which is currently randomizing patients to concurrent biochemotherapy with CVD plus IL-2 and IFN-alpha versus CVD alone .

###22099051
OBJECTIVE	To observe the effects of recombinant human endostatin ( RHES ) on the radiosensitivity of non-small cell lung cancer ( NSCLC ) .
METHODS	First , 10 hypoxia-positive cases of pathology-diagnosed NSCLC selected from 15 patients were used to determine the normalization window , a period during which RHES improves NSCLC hypoxia .
METHODS	Second , 50 hypoxia-positive cases of pathology-diagnosed NSCLC ( Stages I-III ) were randomly divided into a RHES plus radiotherapy group ( 25 cases ) and a radiotherapy-alone group ( 25 cases ) .
METHODS	Intensity = modulated radiotherapy with a total dose of 60 Gy in 30 fractions for 6 weeks was adopted in the two groups .
METHODS	The target area included primary foci and metastatic lymph nodes .
METHODS	In the RHES plus radiotherapy group , RHES ( 15 mg/day ) was intravenously given during the normalization window .
RESULTS	After RHES administration , the tumor-to = normal tissue radioactivity ratio and capillary permeability surface were first decreased and then increased , with their lowest points on the fifth day compared with the first day ( all p < 0.01 ) .
RESULTS	Blood flow was first increased and then decreased , with the highest point on the fifth day , compared with the first and tenth day ( all p < 0.01 ) .
RESULTS	In the RHES plus radiotherapy group and the radiotherapy-alone group , the total effective rates ( complete response plus partial response ) were 80 % and 44 % ( p = 0.009 ) , respectively .
RESULTS	The median survival times were 21.1 0.97 months and 16.5 0.95 months ( p = 0.004 ) , respectively .
RESULTS	The 1-year and 2-year local control rates were 78.9 8.4 % and 68.1 7.8 % ( p = 0.027 ) and 63.6 7.2 % and 43.4 5.7 % ( p = 0.022 ) , respectively .
RESULTS	The 1-year and 2-year overall survival rates were 83.3 7.2 % and 76.6 9.3 % ( p = 0.247 ) and 46.3 2.4 % and 37.6 9.1 % ( p = 0.218 ) , respectively .
CONCLUSIONS	The RHES normalization window is within about 1 week after administration .
CONCLUSIONS	RHES combined with radiotherapy within the normalization window has better short-term therapeutic effects and local control rates and no severe adverse reactions in the treatment of NSCLC , but it failed to significantly improve the 1-year and 3-year overall survival rates .

###9323618
OBJECTIVE	To assess : ( i ) the size of placental transfusion following a 30 s delay in cord clamping following vaginal and Caesarean births ; and ( ii ) the feasibility of delaying cord clamping in the labour ward and particularly in the operating theatre .
METHODS	Fourty-six infants born at 26-33 weeks gestation were randomized to having the umbilical cord clamped either immediately or 30 s after birth .
METHODS	The venous haematocrit was measured at 1 and at 4 h of age .
RESULTS	There were trends towards higher mean haematocrits in the infants following delayed clamping , but these were not significant either at 1 h ( 55 + / - 7.7 vs 52.9 + / - 7 ) or at 4 h of age ( 55 + / - 7 vs 52.5 + / - 7 ) .
RESULTS	The trends were more marked in the infants born by Caesarean section , and in those born at 26-29 weeks gestation .
CONCLUSIONS	A 30 s delay in cord clamping is feasible at both vaginal and Caesarean births , but does not lead to the predicted difference in infant haematocrit .
CONCLUSIONS	Although physiological studies suggest that a placental transfusion of 15-20 mL/kg occurs within 30 s of delivery , these data suggest that future trials should either delay cord clamping for more than 30 s , or should alter the position of the infant in relation to the uterus in order to facilitate the transfusion .
CONCLUSIONS	Delayed cord clamping is feasible at Caesarean section .

###22016919
OBJECTIVE	To evaluate the microtensile bond strengths ( microTBS ) of 1-step vs. 2-step self-etch systems to dentin after 24 hours and after 6 months of water storage .
METHODS	Resin composite buildups were bonded to occlusal dentin of third molars using the following adhesives : Xeno IV ( XE , Dentsply ) , G-Bond ( GB , GC Inc ) , Clearfil S3 Bond ( CS3 , Kuraray ) ; Adper Prompt L-Pop ( AD , 3M ESPE ) ; Go ( GO , SDI ) , All Bond SE ( ABSE 1-step or ABSE 2-step , Bisco ) and Clearfil SE Bond ( CSE , Kuraray ) .
METHODS	The bonded sticks ( cross-sectioned area of 0.8-0 .9 mm2 ) originated from the same teeth were randomly divided to be tested after 24 hours or after 6 months of water storage .
METHODS	The data was submitted to two-way repeated measures ANOVA and Tukey 's test with and without the inclusion of premature failures ( PF ) ( alpha = 0.05 ) .
RESULTS	The inclusion of PF resulted in different statistically significant means for CS3 , CSE and AD ( P < 0.05 ) .
RESULTS	Only the ABSE2 showed stable bonds after 6 months of water storage ( P > 0.05 ) .

###12208707
OBJECTIVE	The European Glaucoma Prevention Study seeks to evaluate the efficacy of reducing intraocular pressure ( IOP ) , with dorzolamide to prevent or delay patients affected by ocular hypertension from developing primary open-angle glaucoma .
METHODS	Randomized , double-blinded , controlled clinical trial .
METHODS	Patients ( age > or = 30 years ) were enrolled from 18 European centers .
METHODS	The patients fulfilled a series of inclusion criteria including the measurements of IOP ( 22-29 mmHg ) , two normal and reliable visual fields ( VFs ) ( on the basis of mean defect and corrected pattern standard deviation/corrected loss of variance of standard 30/II Humphrey or Octopus perimetry ) , and normal optic disc as determined by the Optic Disc Reading Center ( vertical and horizontal cup-to-disc ratios ; asymmetry between the two eyes < or = 0.4 ) .
METHODS	Patients were randomized to the treatment with dorzolamide or a placebo .
METHODS	End points are VF and/or optic disc changes .
METHODS	A VF change during the follow-up must be confirmed by two further positive tests .
METHODS	Optic disc change is defined by the agreement of two out of three independent observers evaluating optic disc stereo-slides .
RESULTS	One thousand seventy-seven subjects were randomized between January 1 , 1997 and May 31 , 1999 .
RESULTS	The mean age was 57.03 + / - 10.3 years ; 54.41 % were women and 99.9 % were Caucasian .
RESULTS	Mean IOP was 23.6 + / - 1.6 mmHg in both eyes .
RESULTS	Mean visual acuity was 0.97 + / - 0.11 in both eyes ; mean refraction was 0.23 + / - 1.76 diopters in the right eye and 0.18 + / - 1.79 diopters in the left eye .
RESULTS	Previous use of medication for ocular hypertension was reported by 38.4 % of the patients , systemic hypertension by 28.1 % , cardiovascular diseases by 12.9 % , and diabetes mellitus by 4.7 % .
RESULTS	The qualifying VFs were normal and reliable according to protocol criteria .
CONCLUSIONS	The mean IOP of the patients enrolled in the European Glaucoma Prevention Study is consistent with the estimated mean IOP ( within the range of 22-29 mmHg ) found in a large sample of the European population .
CONCLUSIONS	The European Glaucoma Prevention Study should be able to better address the clinical question of whether pharmacological reduction of IOP ( by means of dorzolamide ) in ocular hypertension patients at moderate risk for developing primary open-angle glaucoma effectively lowers the incidence of primary open-angle glaucoma .

###12859089
OBJECTIVE	To compare , using transmission electron microscopy ( TEM ) , the ultrastructure of the hybrid layers formed beneath a one-bottle adhesive system using the total-etch technique with that of a self-etching system .
METHODS	Occlusal cavity preparations were made in vivo in 18 human premolars and randomly appointed to three groups ( n = 6 ) , according to the following bonding procedures : ( 1 ) OptiBond Solo , a single-bottle adhesive system , was applied following 15 seconds etching with 37 % phosphoric acid and rinsing ; ( 2 ) Clearfil Liner Bond 2V , a self-etching adhesive system was applied ; and ( 3 ) no bonding material was used , with the untreated smear layer acting as a control .
METHODS	The cavities were then filled with resin composite restorations .
RESULTS	In group 1 , dense resin tags obturated the tubules .
RESULTS	A layer of inorganic silicon microgranules formed at the top of the interdiffusion zone , and below this was a zone of loosely arranged collagen fibers .
RESULTS	Toward the base , there was a more dense accumulation of hydroxyapatite crystals .
RESULTS	In group 2 , dense resin tags obturated the tubular orifices .
RESULTS	Collagen fibers were densely compacted within monomer material .
RESULTS	Toward the base , hydroxyapatite crystals were observed between collagen bundles .
RESULTS	In group 3 , a rough fragmented smear layer covered the dentinal floor and occluded the tubules .
CONCLUSIONS	Irregularities occurred in the coronal zone of the hybrid layer in both systems .
CONCLUSIONS	In the one-bottle system , this was attributed to the etching technique , while in the case of the self-etching system , this was attributed to the resin materials .
CONCLUSIONS	These irregularities are potential sites for debonding in the clinical situation .

###11852377
OBJECTIVE	To test a blood glucose monitor developed upon diabetic 's recommendations ( Glucotrend Premium ) .
OBJECTIVE	Self-monitoring of blood glucose ( SMBG ) generates hope when introduced , however several studies questioned its efficacy and many diabetics judge it too constraining .
METHODS	Thirty diabetes centres in France , for 6 months in 179 insulin-treated diabetics , using SMBG but non optimally and with HbA ( 1c ) ( > = 130 % of the upper limit ) .
METHODS	Randomisation to 3 groups : either their previous system ( Group A ) , or to the Glucotrend Premium monitor with a memory to assess compliance ( Group B ) , or to another monitor , new for the patient , and with a memory too , the One Touch Profile ( Group C ) .
METHODS	At entry , and then at 3 and 6 months , patients had an acceptability and compliance questionnaire , HbA ( 1c ) , count of weekly hypoglycaemia , record of insulin doses and an assessment of the key compliance factors .
RESULTS	HbA ( 1c ) improved significantly in the 3 groups , more markedly in groups B ( Glucotrend ) and C ( One Touch ) , e.g. - 0.6 + / - 1.1 % ( group A ) , - 0.9 + / - 1.2 % ( group B ) and - 1.0 + / - 0.9 % ( group C ) at M6 .
RESULTS	Acceptability was judged better for groups B and C , an additional benefit for Glucotrend : better accuracy vs laboratory blood glucose ( C/L ) determinations and a lower utilisation cost .
RESULTS	Intermediate ( lente ) and regular insulin doses only significantly decreased ( 26 % and 10 % respectively ) in group B ( Glucotrend ) despite a decrease in HbA ( 1c ) .
RESULTS	Compliance ( defined as 75-150 % of recommended self-monitoring ) improved within the 3 groups ( from 34 % to 65 % ) , this improvement was maintained after month 3 ( M6 : 76 % ) only in group B ( Glucotrend ) , vs a worsening in groups A and C ( M6 : 62 and 57 % respectively ) .
RESULTS	A better accuracy of C/L was observed with Glucotrend at M0 , M3 and M6 .
CONCLUSIONS	SMBG has limits due to various causes , and to specific difficulties of this invasive and repetitive technique .
CONCLUSIONS	The development of a system based on advices formulated by patients themselves , Glucotrend Premium , has resulted in a marked improvement on acceptability , compliance and glucose control .

###23746429
BACKGROUND	Electronic cigarettes , or e-cigarettes , are battery operated devices that deliver nicotine via inhaled vapor .
BACKGROUND	There is considerable controversy about the disease risk and toxicity of e-cigarettes and empirical evidence on short - and long-term health effects is minimal .
BACKGROUND	Limited data on e-cigarette use and correlates exist , and to our knowledge , no prevalence rates among U.S. college students have been reported .
BACKGROUND	This study aimed to estimate the prevalence of e-cigarette use and identify correlates of use among a large , multi-institution , random sample of college students .
METHODS	4444 students from 8 colleges in North Carolina completed a Web-based survey in fall 2009 .
RESULTS	Ever use of e-cigarettes was reported by 4.9 % of students , with 1.5 % reporting past month use .
RESULTS	Correlates of ever use included male gender , Hispanic or `` Other race '' ( compared to non-Hispanic Whites ) , Greek affiliation , conventional cigarette smoking and e-cigarette harm perceptions .
RESULTS	Although e-cigarette use was more common among conventional cigarette smokers , 12 % of ever e-cigarette users had never smoked a conventional cigarette .
RESULTS	Among current cigarette smokers , e-cigarette use was negatively associated with lack of knowledge about e-cigarette harm , but was not associated with intentions to quit .
CONCLUSIONS	Although e-cigarette use was more common among conventional cigarette smokers , it was not exclusive to them .
CONCLUSIONS	E-cigarette use was not associated with intentions to quit smoking among a sub-sample of conventional cigarette smokers .
CONCLUSIONS	Unlike older , more established cigarette smokers , e-cigarette use by college students does not appear to be motivated by the desire to quit cigarette smoking .

###23689964
OBJECTIVE	The purpose of this study is to compare the clinical and subjective difference between transtendon repair or complete/repair in two homogeneous groups of patients affected by deep partial articular supraspinatus tear .
METHODS	Seventy-four patients were randomized in two groups of 37 patients each .
METHODS	The first group ( A ) was treated with arthroscopic transtendon repair while the second group ( B ) was treated with an arthroscopic completion of the tear and formal repair .
METHODS	All the patients were revaluated at a minimum 2 years of follow-up with Constant score and Visual Analogic Scale ( VAS ) .
RESULTS	Constant score improved by a mean value of 25 ( 95 % CI 21-28 ) ( p < 0.0001 ) and of 29 ( 95 % CI 26-31 ) ( p < 0.0001 ) , respectively ; VAS score decreased by a mean value of 3.4 ( 95 % CI 2.9-3 .9 ) ( p < 0.0001 ) and of 3.6 ( 95 % CI 3.3-4 .0 ) ( p < 0.0001 ) , respectively .
RESULTS	The improvement was higher in both groups for the ADL , and in Group B , the improvement in strength was higher than in Group A.
RESULTS	There were no statistical differences between the two different techniques .
CONCLUSIONS	Both repairing techniques of deep partial supraspinatus tear provide good results in terms of function and pain .
CONCLUSIONS	There were no statistically significant differences between the two techniques .
METHODS	Prospective comparative study , Level II .

###10769276
BACKGROUND	Exaggerated postprandial lipemia ( PPL ) is a factor in atherogenesis , involving endothelial dysfunction and enhanced oxidative stress .
BACKGROUND	We examined the effect of ciprofibrate therapy on these parameters in type 2 diabetes mellitus .
RESULTS	Twenty patients entered a 3-month , double-blind , placebo-controlled study .
RESULTS	Each subject was studied fasting and after a fatty meal , at baseline , and after 3 months of treatment .
RESULTS	Glucose and lipid profiles were measured over an 8-hour postprandial period .
RESULTS	Endothelial function ( flow-mediated endothelium-dependent vasodilatation [ FMD ] ) and oxidative stress ( electron paramagnetic resonance spectroscopy ) were measured after fasting and 4 hours postprandially .
RESULTS	At baseline , both groups exhibited similar PPL and deterioration in endothelial function .
RESULTS	After ciprofibrate , fasting and postprandial FMD values were significantly higher ( from 3.8 + / -1.8 % and 1.8 + / -1.3 % to 4.8 + / -1.1 % and 3.4 + / -1.1 % ; P < 0.05 ) .
RESULTS	This was mirrored by a fall in fasting and postprandial triglycerides ( 3.1 + / -2.1 and 6.6 + / -4.1 mmol/L to 1.5 + / -0.8 and 2.8 + / -1.3 mmol/L , P < 0.05 ) .
RESULTS	Fasting and postprandial HDL cholesterol was also elevated ( 0.9 + / -0.1 and 0.8 + / -0.1 mmol/L and 1.2 + / -0.2 and 1.2 + / -0.1 mmol/L , P < 0.05 ) .
RESULTS	There were no changes in total or LDL cholesterol .
RESULTS	Fasting and postprandial triglyceride enrichment of all lipoproteins was attenuated , with cholesterol depletion of VLDL and enrichment of HDL .
RESULTS	There were similar postprandial increases in oxidative stress in both groups at baseline , which was significantly attenuated by ciprofibrate ( 0.3 + / -0.6 versus 1.5 + / -1.1 U , P < 0.05 ) .
CONCLUSIONS	This study demonstrates that fibrate therapy improves fasting and postprandial endothelial function in type 2 diabetes .
CONCLUSIONS	Attenuation of PPL and the associated oxidative stress , with increased HDL cholesterol levels , may be important .

###17015541
OBJECTIVE	The aim of this study was to determine the site , extent , and resolution of tissue involvement when extensive limb swelling occurred in the injected limb for children who received diphtheria-tetanus-acellular pertussis or reduced-antigen content diphtheria-tetanus-acellular pertussis vaccine at 4 to 6 years of age .
METHODS	Children who had experienced an injection site reaction at 18 months of age were assigned randomly to receive an intramuscular injection of either reduced-antigen content diphtheria-tetanus-acellular pertussis vaccine or diphtheria-tetanus-acellular pertussis vaccine between 4 and 6 years of age .
METHODS	Children who developed extensive limb swelling were recruited for assessment by clinical examination ; ultrasound studies of the affected and opposite ( control ) arms were performed 24 to 48 hours after immunization and 48 to 96 hours later .
RESULTS	Twelve children with extensive limb swelling were enrolled in the study .
RESULTS	Ultrasound examinations demonstrated swelling of both the subcutaneous and muscle layers of the vaccinated arm .
RESULTS	Ultrasound assessment showed that the swelling exceeded the clinical measurements of skin redness and swelling .
RESULTS	Subcutaneous and muscle tissues expanded to 281 % and 111 % of the tissue thicknesses of the control arm , respectively .
RESULTS	Repeat ultrasound examinations after 48 to 96 hours showed considerable resolution of muscle swelling , compared with subcutaneous tissue swelling .
RESULTS	There was no significant difference in the extent of swelling detected between children who received diphtheria-tetanus-acellular pertussis vaccine and those who received reduced-antigen content diphtheria-tetanus-acellular pertussis vaccine .
CONCLUSIONS	Extensive limb swelling reactions after diphtheria-tetanus-acellular pertussis or reduced-antigen content booster immunizations involved swelling of subcutaneous and muscle tissues with swelling and duration more marked in subcutaneous tissue .

###15362593
BACKGROUND	Although it is a commonly held belief that the ingestion of drugs with an anticholinergic action would prolong the duration of time after drug ingestion for effective gastrointestinal decontamination , data are lacking to support this belief .
BACKGROUND	The purpose of this study is to determine whether activated charcoal is more effective in the presence of concurrent anticholinergic activity .
METHODS	A three-limbed randomized crossover study in 10 healthy volunteers was completed to determine the ability of a 50 g dose of activated charcoal to reduce the bioavailability of a simulated overdose of acetaminophen ( 12 x 325 mg tablets ) in the presence and absence of a concurrently present anticholinergic drug , atropine ( 0.01 mg/kg I. M. administered 15 min prior to the acetaminophen ingestion ) .
RESULTS	After the acetaminophen ingestion , median Cmax occurred at 1 h for all three exposures but was lower in the atropine-treated study arm ( 31 + / -19 mg/L ) than in the control or charcoal alone intervention arms ( 49 + / -13 and 51 + / -16 mg/L , respectively ) ( P < 0.05 ) .
RESULTS	Compared to the control area under the serum concentration vs. time curve , a single dose of activated charcoal 1 h after drug ingestion reduced acetaminophen bioavailability by 20 % ( 95 % CI 4-36 % ) and by 47 % ( 95 % CI 35-59 % ) in the presence of atropine ( P < 0.05 atropine plus charcoal vs. charcoal alone ) .
CONCLUSIONS	Our data support the belief that activated charcoal is more effective in the presence of anticholinergic activity .
CONCLUSIONS	Additional study is required to determine whether in patients with anticholinergic drug overdose , activated charcoal is effective at times beyond the recommendation for overdoses of drugs without this pharmacodynamic effect .

###24913337
OBJECTIVE	Adverse events ( AEs ) are health related events , reported by participants in clinical trials .
OBJECTIVE	We describe AEs in the PACE trial of treatments for chronic fatigue syndrome ( CFS ) and baseline characteristics associated with them .
METHODS	AEs were recorded on three occasions over one year in 641 participants .
METHODS	We compared the numbers and nature of AEs between treatment arms of specialist medical care ( SMC ) alone , or SMC supplemented by adaptive pacing therapy ( APT ) , cognitive behaviour therapy ( CBT ) or graded exercise therapy ( GET ) .
METHODS	We examined associations with baseline measures by binary logistic regression analyses , and compared the proportions of participants who deteriorated by clinically important amounts .
RESULTS	Serious adverse events and reactions were infrequent .
RESULTS	Non-serious adverse events were common ; the median ( quartiles ) number was 4 ( 2 , 8 ) per participant , with no significant differences between treatments ( P = .47 ) .
RESULTS	A greater number of NSAEs were associated with recruitment centre , and baseline physical symptom count , body mass index , and depressive disorder .
RESULTS	Physical function deteriorated in 39 ( 25 % ) participants after APT , 15 ( 9 % ) after CBT , 18 ( 11 % ) after GET , and 28 ( 18 % ) after SMC ( P < .001 ) , with no significant differences in worsening fatigue .
CONCLUSIONS	The numbers of adverse events did not differ significantly between trial treatments , but physical deterioration occurred most often after APT .
CONCLUSIONS	The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments .
CONCLUSIONS	Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data .

###12663288
BACKGROUND	Dietary supplements providing physiologic amounts of several micronutrients simultaneously have not been thoroughly tested for combating micronutrient deficiencies .
OBJECTIVE	We determined whether a beverage fortified with 10 micronutrients at physiologic doses influenced the iron and vitamin A status and growth of rural children ( aged 6-11 y ) attending primary schools .
METHODS	In this randomized , double-blind , placebo-controlled efficacy trial , children were assigned to receive the fortified beverage or an unfortified beverage at school for 6 mo. .
RESULTS	There were nonsignificant differences at baseline between children in the fortified and nonfortified groups in iron status , serum retinol , and anthropometry .
RESULTS	At the 6-mo follow-up , among children with anemia ( hemoglobin < 110 g/L ) , there was a significantly larger increase in hemoglobin concentration in the fortified group than in the nonfortified group ( 9.2 and 0.2 g/L , respectively ) .
RESULTS	Of those who were anemic at baseline , 69.4 % in the nonfortified group and 55.1 % in the fortified group remained anemic at follow-up ( RR : 0.79 ) , a cure rate of 21 % .
RESULTS	The prevalence of children with low serum retinol concentrations ( < 200 microg/L ) dropped significantly from 21.4 % to 11.3 % in the fortified group compared with a nonsignificant change ( 20.6 % to 19.7 % ) in the nonfortified group .
RESULTS	At follow-up , mean incremental changes in weight ( 1.79 compared with 1.24 kg ) , height ( 3.2 compared with 2.6 cm ) , and BMI ( 0.88 compared with 0.53 ) were significantly higher in the fortified group than in the nonfortified group .
CONCLUSIONS	The fortified beverage significantly improved hematologic and anthropometric measurements and significantly lowered the overall prevalence of anemia and vitamin A deficiency .

###15313106
BACKGROUND	Both self-help print materials and telephone-assisted counseling have generally proved useful strategies to increase physical activity .
BACKGROUND	This study examined their effectiveness in an intervention aimed specifically at promoting walking for specific purposes .
METHODS	Participants ( n = 399 ) were randomly allocated to one of two 3-week intervention programs .
METHODS	The Print program comprised multiple mailing of brochures that emphasized walking within the local community environments .
METHODS	The Print plus Telephone program received the same brochures plus three telephone calls .
METHODS	Data collected via mailed self-completed surveys were analyzed by exploring outcomes related to walking for specific purposes .
RESULTS	There were no significant differences between the two programs in any of the walking measures .
RESULTS	Both groups significantly increased time reported walking for exercise per week [ Print : t ( 1,277 ) = -3.50 , P < 0.001 ; Print plus telephone : t ( 1,106 ) = -2.44 , P < 0.016 ] .
RESULTS	Significantly , more participants in the Print plus Telephone group reported receiving and reading the materials ( chi2 = 20.11 , P < 0.0001 ) .
CONCLUSIONS	The intervention programs were more successful at increasing walking for exercise than for any other purpose .
CONCLUSIONS	The addition of brief telephone support was successful in focusing participants ' attention on the print materials , but did not result in any additional increase in walking .

###9118764
OBJECTIVE	To conduct a prospective evaluation of footwear characteristics as predictors of diabetic foot wounds .
METHODS	A total of 352 patients with NIDDM enrolled in a randomized controlled trial aimed at preventing diabetic foot lesions in an academic general medicine practice were studied .
METHODS	Foot wounds ( n = 63 ) were modeled univariately and multivariably using generalized estimating equations .
METHODS	The dependent variable was a wound classified as a 1.2 or greater according to the Seattle Wound Classification System , indicating at least a superficial or healing minor lesion with no functional interruption of the protective cutaneous barrier .
METHODS	Independent variables included detailed measures of style and material of patients ' indoor and outdoor shoes , appropriate length and width , sock fibers , whether the patient had bought new shoes in the past 6 months , and if the patient had been recommended for special shoes .
METHODS	Modeling controlled for intervention status and physiological measures ( baseline wound , monofilament abnormalities , and serum HDL level ) .
RESULTS	Initial screening ( P < 0.20 ) suggested that a recommendation for special shoes , shoe length , and shoe width were indicative of wounds at follow-up ( odds ratios [ ORs ] 2.19 , 1.84 , 1.86 , respectively ) , while having bought shoes in the past 6 months was associated with no wound at follow-up ( OR 0.60 ) .
RESULTS	The final multivariable model included only the recommendation for special shoes ( OR 2.19 ; 95 % CI 1.07-4 .49 ) .
CONCLUSIONS	Many variables commonly cited as protective measures in footwear for diabetic patients were not prospectively predictive when controlling for physiological risk factors .
CONCLUSIONS	Rigorous analyses are needed to examine the many assumptions regarding footwear recommendations for diabetic patients .

###16369463
BACKGROUND	Mind/body practices that elicit the relaxation response ( RR ) are currently practiced by over 30 % of American adults .
BACKGROUND	RR elicitation reduces volumetric oxygen consumption ( VO ( 2 ) ) from rest and counteracts the effects of stress , although the mechanisms mediating the RR remain unknown .
BACKGROUND	This study was designed to investigate whether RR elicitation is mediated by nitric oxide ( NO ) .
BACKGROUND	We developed a method to quantify depth of RR using change in VO ( 2 ) ( slope ) during RR elicitation .
BACKGROUND	We evaluated whether depth of RR elicitation was correlated with changes in NO , as measured by percentage changes in fractional exhaled nitric oxide ( F ( E ) NO ) .
METHODS	We conducted a randomized , controlled trial , in which 46 subjects were randomized to either 8-weeks of RR training using audiotapes ( n = 34 ) or 8-weeks of exposure to a control condition -- receiving health-education by audiotapes ( n = 12 ) .
METHODS	Prior to randomization , VO ( 2 ) and F ( E ) NO were measured while subjects listened to a control audiotape .
METHODS	Eight weeks later , VO ( 2 ) and F ( E ) NO were measured while the RR group listened to a RR-eliciting audiotape and the control group listened to a control audiotape .
RESULTS	Prior to receiving any training , there was no association between VO ( 2 ) slope and F ( E ) NO .
RESULTS	After training , there was an inverse correlation between VO ( 2 ) slope and F ( E ) NO in the RR group ( r = -0.41 , P = 0.037 , n = 26 ) , but not in the control group ( r = 0.12 , P = 0.78 , n = 8 ) .
CONCLUSIONS	Depth of RR elicitation was associated with increased concentrations of F ( E ) NO after RR training .
CONCLUSIONS	The RR may be mediated by NO helping to explain its clinical effects in stress-related disorders .

###24238498
BACKGROUND	A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis ( PD ) solutions .
BACKGROUND	Some researchers believe that 6 L/d is enough for adequate dialysis , but there is no multi-center prospective study on Chinese population to confirm this .
BACKGROUND	In this study , we evaluated the efficacy and safety of domestic PD solution ( Changfu ) and its difference between 6 L and 8 L dosage .
METHODS	Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages , i.e. , 6 L dose with Changfu dialysis solution , 6 L dose with Baxter dialysis solution , 8 L dose with Changfu dialysis solution , and 8 L dose with Baxter dialysis solution .
METHODS	After 48 weeks , the changes of primary and secondary efficacy indices were compared between different types and different dosages .
METHODS	We also analyzed the changes of safety indices .
RESULTS	Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of creatinine clearance rate ( Ccr ) .
RESULTS	Normalized protein catabolic rate ( nPCR ) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of net ultrafiltration volume ( nUF ) and estimated glomerular filtration rate ( eGFR ) .
RESULTS	Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences ; so did those of nUF and eGFR .
RESULTS	The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group .
RESULTS	Change of Ccr was similar .
RESULTS	During the 48-week period , the mean Kt/V was above 1.7 / w , and mean Ccr was above 50 L1 .73 m ( -2 ) w ( -1 ) .
RESULTS	More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization , and the statistical differences disappeared after that .
CONCLUSIONS	The domestic PD solution ( Changfu ) was proven to be as effective as Baxter dialysis solution .
CONCLUSIONS	During 48-week period , a dosage of 6 L/d was enough for these patients to reach adequate PD .
CONCLUSIONS	Clinical study promotes technological optimization , further helps to improve the safety indices of the medical products .

###17162400
BACKGROUND	Inhalation anesthetics such as isoflurane , sevoflurane , and desflurane are widely used in clinical practice ; however , there is no study for comparing these drugs in cardiac surgery with respect to postoperative cognitive outcome and S100 beta protein ( S100 BP ) levels .
BACKGROUND	In this study , we evaluated the effect of sevoflurane , isoflurane , and desflurane anesthesia on neuropsychological outcome and S100 BP levels in patients undergoing coronary artery bypass grafting ( CABG ) surgery with cardiopulmonary bypass ( CPB ) .
METHODS	Forty-two male patients were prospectively randomized and classified into 3 groups according to the volatile agents used ; isoflurane , sevoflurane , desflurane .
METHODS	All patients had a sufficient education level to participate in neuropsychological testing and a normal carotid Doppler ultrasonography .
METHODS	Blood samples for analysis of S100 BP were collected before anesthesia ( T1 ) , before heparinization ( T2 ) , 15 minutes into CPB ( T3 ) , following protamine administration ( T4 ) , postoperatively ( T5 ) , 24 hours after the operation ( T6 ) , postoperative day 3 ( T7 ) , and postoperative day 6 ( T8 ) .
METHODS	The neuropsychological tests , including Mini-Mental State Examination ( MMSET ) and visual-aural digit span test ( VADST ) , were administered 1 day prior to surgery and on the third and sixth postoperative days .
RESULTS	The postoperative third and sixth day MMSET scores and third day visual-written subtest scores in the sevoflurane group were significantly lower than in the isoflurane and desflurane groups ( P < .05 ) .
RESULTS	S100 BP levels increased with the beginning of anesthesia in the sevoflurane and desflurane groups .
RESULTS	Although S100 BP decreased to baseline levels on postoperative day 1 in the sevoflurane group , this was significantly higher on the third and sixth days postoperatively in the desflurane group ( P < .05 ) .
RESULTS	In the isoflurane group , the S100 BP level was significantly higher than the baseline level only after CPB ( P < .05 ) .
CONCLUSIONS	Our study suggests that isoflurane is associated with better neurocognitive functions than desflurane or sevoflurane after on-pump CABG .
CONCLUSIONS	Sevoflurane seems to be associated with the worst cognitive outcome as assessed by neuropsychologic tests , and prolonged brain injury as detected by high S100 BP levels was seen with desflurane .

###17210079
BACKGROUND	Many drug users present to primary care requesting detoxification from illicit opiates .
BACKGROUND	There are a number of detoxification agents but no recommended drug of choice .
BACKGROUND	The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care .
METHODS	Open label randomised controlled trial in NHS Primary Care ( General Practices ) , Leeds , UK .
METHODS	Sixty consenting adults using illicit opiates received either daily sublingual buprenorphine or daily oral dihydrocodeine .
METHODS	Reducing regimens for both interventions were at the discretion of prescribing doctor within a standard regimen of not more than 15 days .
METHODS	Primary outcome was abstinence from illicit opiates at final prescription as indicated by a urine sample .
METHODS	Secondary outcomes during detoxification period and at three and six months post detoxification were recorded .
RESULTS	Only 23 % completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription .
RESULTS	Risk of non-completion of detoxification was reduced if allocated buprenorphine ( 68 % vs 88 % , RR 0.58 CI 0.35-0 .96 , p = 0.065 ) .
RESULTS	A higher proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine ( 21 % vs 3 % , RR 2.06 CI 1.33-3 .21 , p = 0.028 ) .
RESULTS	People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were abstinent at three months ( 10 vs 4 , RR 1.55 CI 0.96-2 .52 ) and six months post detoxification ( 7 vs 3 , RR 1.45 CI 0.84-2 .49 ) .
CONCLUSIONS	Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations .
CONCLUSIONS	This small study generates unique data on commonly used treatment regimens .

###11318256
BACKGROUND	Socioeconomic status is often used to explain race differences in sexually transmitted diseases ( STDs ) , yet the independent association of socioeconomic status and STDs among adolescents has been understudied .
OBJECTIVE	To examine the associations between socioeconomic status and self-reported gonorrhea among black female adolescents , after controlling for sexual risk behaviors .
METHODS	Interviews and surveys were completed by 522 sexually active black adolescent females residing in low-income urban neighborhoods .
RESULTS	Adolescents whose parents were unemployed were more than twice as likely to report a history of gonorrhea , compared with those with employed parents .
RESULTS	Adolescents living with two parents were less likely to report a history of gonorrhea .
CONCLUSIONS	The results of this study indicate that gonorrhea is associated with low socioeconomic status among black adolescent females regardless of the level of sexual risk behaviors .
CONCLUSIONS	Lower socioeconomic status may be an marker for risky sociosexual environments .

###21381157
BACKGROUND	Exposure and response prevention ( ERP ) for obsessive-compulsive disorder ( OCD ) is underutilized , in part because of costs and time requirements .
BACKGROUND	This study extends pilot work investigating the use of a stepped care ERP administration , in which patients are first given a low-intensity , low-cost treatment and the more costly intervention is reserved for those who do not respond to the first intervention .
METHODS	Thirty adults with OCD were randomized to receive stepped care ERP or standard ERP .
METHODS	Those receiving stepped care started with three sessions over 6 weeks of low-intensity counseling with ERP bibliotherapy ; patients failing to meet strict responder criteria after 6 weeks were given the more traditional treatment of therapist-administered ERP ( 17 sessions twice weekly ) .
METHODS	Those receiving standard ERP received the therapist-administered ERP with no lower-intensity lead-in .
RESULTS	The two treatments were equally efficacious , with 67 % of stepped care completers and 50 % of standard treatment completers meeting criteria for clinically significant change at posttreatment .
RESULTS	Similarly , no differences in client satisfaction ratings were obtained between the two groups .
RESULTS	Examination of treatment costs , however , revealed that stepped care resulted in significantly lower costs to patients and third-party payers than did standard ERP , with large effect sizes .
CONCLUSIONS	These results suggest that stepped care ERP can significantly reduce treatment costs , without evidence of diminished treatment efficacy or patient satisfaction .
CONCLUSIONS	Additional research is needed to determine the long-term efficacy and costs of stepped care for OCD , and to examine the financial and therapeutic impact of implementing stepped care in community settings .

###11336163
BACKGROUND	Nutritional therapy plays an important role in the management of Crohn disease , particularly during the acute phase .
BACKGROUND	Nutritional supplementation may also prevent relapses during the quiescent phase of Crohn disease , though this aspect has not been widely explored .
METHODS	Thirty-three patients with Crohn disease in remission were studied .
METHODS	All had steroid-dependent disease .
METHODS	Patients were randomized to receive either elemental diet ( n = 19 , EO28 Extra ) or polymeric diet ( Forticips , n = 14 ) .
METHODS	The supplement was given orally in addition to normal food in an amount to provide 35 % -50 % of pre-trial total calorie intake .
METHODS	Prednisolone was withdrawn gradually .
METHODS	Patients were followed up for 12 months .
METHODS	Failure was defined as increase in CDAI by 100 points from baseline to > 200 , inability to withdraw chronic steroid therapy completely , need for surgery or steroid therapy .
RESULTS	The nutritional supplement was successful in 14 ( 43 % ) patients who remained in remission for 12 months with complete withdrawal of steroids .
RESULTS	The response to elemental diet ( 42 % ) was similar to that of polymeric diet ( 43 % ) .
RESULTS	Nutrition supplement failed in 13 ( 39 % ) .
RESULTS	Six ( 18 % ) patients were intolerant to enteral feeding because of smell and taste problems .
RESULTS	Per-protocol analysis of data indicated that the success rate of nutrition supplement in steroid-dependent patients was 52 % ( 14 out of 27 patients ) .
RESULTS	No disease or patient-related factors helped predict the response to nutrition supplement .
CONCLUSIONS	Nutritional supplementation with either an elemental or polymeric diet may provide a safe and effective alternative to chronic steroid therapy in patients with steroid-dependent Crohn disease .

###25837277
BACKGROUND	We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea ( R. rosea ) versus sertraline for mild to moderate major depressive disorder .
OBJECTIVE	We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events .
METHODS	Phase II randomized placebo controlled clinical trial .
METHODS	57 subjects were randomized to 12 weeks of standardized R. rosea extract , sertraline , or placebo .
METHODS	Changes over time in Hamilton Depression Rating ( HAM-D ) , Beck Depression Inventory ( BDI ) , and Clinical Global Impression Change ( CGI/C ) scores among groups were examined using mixed-effects models .
RESULTS	Modest , albeit statistically non-significant , reductions were observed for HAM-D , BDI , and CGI/C scores for all treatment conditions with no significant difference between groups ( p = 0.79 , p = 0.28 , and p = 0.17 , respectively ) .
RESULTS	The decline in HAM-D scores was greater for sertraline ( -8.2 , 95 % confidence interval [ CI ] , -12.7 to -3.6 ) versus R. rosea ( -5.1 , 95 % CI : -8.8 to -1.3 ) and placebo ( -4.6 , 95 % CI : -8.6 to -0.6 ) .
RESULTS	While the odds of improving ( versus placebo ) were greater for sertraline ( 1.90 [ 0.44-8 .20 ] ; odds ratio [ 95 % CI ] ) than R. rosea ( 1.39 [ 0.38-5 .04 ] ) , more subjects on sertraline reported adverse events ( 63.2 % ) than R. rosea ( 30.0 % ) or placebo ( 16.7 % ) ( p = 0.012 ) .
CONCLUSIONS	Although R. rosea produced less antidepressant effect versus sertraline , it also resulted in significantly fewer adverse events and was better tolerated .
CONCLUSIONS	These findings suggest that R. rosea , although less effective than sertraline , may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression .

###24993832
OBJECTIVE	In light of the high prevalence of sleep disorders in patients suffering from posttraumatic stress disorder ( PTSD ) , this study sought to compare the effect of prazosin and hydroxyzine on sleep quality in this patient group .
METHODS	A total of 100 patients suffering from PTSD were assessed ( mean age = 35.51 years , SD = 6.41 ; 28 % females ) .
METHODS	Next , they were randomly assigned to one of three treatment groups : prazosin ( 33 patients ) , hydroxyzine ( 34 patients ) or placebo ( 33 patients ) .
METHODS	The trial lasted for 8 weeks .
METHODS	The patients ' sleep quality was assessed using the Pittsburgh Sleep Quality Index .
METHODS	Items taken from the Mini International Neuropsychiatric Interview were used to operationalize PTSD .
RESULTS	Compared to controls , patients treated with prazosin and hydroxyzine reported improved sleep and less nightmares .
RESULTS	Improvement was greatest in patients treated with prazosin compared to hydroxyzine and placebo .
RESULTS	Improvement in sleep was associated with an amelioration of their PTSD symptoms .
CONCLUSIONS	Both prazosin and hydroxyzine can be used to treat psychopharmacological sleep disorders and nightmares in patients suffering from PTSD , also leading to reductions in PTSD symptoms .

###21320967
OBJECTIVE	To compare 2-year changes from baseline scores on the National Eye Institute Visual Function Questionnaire ( NEI-VFQ ) between similar participants assigned to sham and no-treatment control arms in randomized clinical trials of treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration .
METHODS	We retrospectively matched sham controls from a randomized trial to no-treatment controls ( no sham or placebo ) from another trial on 7 baseline prognostic criteria .
METHODS	Two-year changes in overall and subscale scores were compared using data from those who had 2-year interviews and also using the last follow-up observation carried forward to impute missing 2-year interview scores .
RESULTS	A match to a no-treatment control on all 7 criteria was identified for 62 of 238 sham controls .
RESULTS	Among the 42 matched pairs of controls interviewed at 2 years , no important difference in 2-year change in NEI-VFQ scores overall or by subscale was observed .
RESULTS	Findings were similar for the 56 matched pairs of controls who could be analyzed for 2-year changes in scores using the method of last follow-up observation carried forward .
CONCLUSIONS	Findings from this retrospective matched-pairs analysis suggest that sham treatment to mask patient participants in clinical trials may be unnecessary when patient-reported outcomes are of interest and standard instruments are administered by interviewers masked to treatment assignment .
CONCLUSIONS	This analysis , together with our earlier analysis of visual acuity outcomes , questions the necessity for sham ( placebo ) controls in randomized clinical trials in ophthalmology when other methods to minimize outcome assessment bias are incorporated into the design .

###16078334
OBJECTIVE	To compare the effects on back pain of teriparatide versus alendronate , we analyzed the reporting of back pain in a head to head comparator trial and a followup study .
METHODS	In the comparator trial , women were randomized to receive either daily self-injected teriparatide 40 microg plus an oral placebo ( n = 73 ) , or daily oral alendronate 10 mg plus self-injected placebo ( n = 73 ) .
METHODS	Treatment was for a median 14 months .
METHODS	After completion of the comparator trial , 72 % of these patients enrolled in a nontreatment followup study .
METHODS	Adverse events were recorded at each comparator trial visit and followup study visit , and the incidence of new or worsening back pain in each group was compared .
RESULTS	During the comparator trial , compared with women randomized to alendronate 10 mg , women randomized to teriparatide 40 microg had reduced risk for any back pain ( relative risk 0.27 , 95 % CI 0.09-0 .82 ) and moderate or severe back pain ( relative risk 0.19 , 95 % CI 0.04-0 .86 ) .
RESULTS	The differences in the reporting of back pain between the teriparatide treated women and the alendronate treated women were sustained during an interval including the comparator trial plus 18 additional months .
RESULTS	During an interval including the comparator trial plus 30 additional months , teriparatide treated patients had numerically fewer occurrences of back pain and moderate or severe back pain .
CONCLUSIONS	Compared with women randomized to alendronate 10 mg , women randomized to teriparatide 40 microg had reduced risk of back pain during the trial and 2.5 years of followup .

###20426290
BACKGROUND	There are no accepted guidelines for the closure of laparotomy incisions in patients of peritonitis .
BACKGROUND	As these patients differ from the patients undergoing elective abdominal surgery , the same recommendations for closure may not be applicable in both groups .
OBJECTIVE	To compare wound outcome parameters following closure of the laparotomy incision with absorbable and non-absorbable suture material using the continuous and interrupted techniques in patients of peritonitis .
METHODS	A single blinded randomised controlled trial using Polygalactin-910 and Polypropylene , number 1 sutures , to close midline vertical incisions , placed in continuous and interrupted manner , was performed on 174 patients .
METHODS	Patients were randomised into four groups : Group A ( Polygalactin-910 continuous suturing , n = 40 ) , B ( Polygalactin-910 interrupted suturing , n = 47 ) , C ( Polypropylene continuous suturing , n = 45 ) and D ( Polypropylene interrupted suturing , n = 42 ) .
METHODS	The incidence of wound infection , dehiscence , suture sinus formation and incisional hernia was recorded .
METHODS	Patients were followed up for a period of four years .
METHODS	Statistical analysis involved the chi-square and Fisher 's exact tests .
METHODS	A ` p ' value of < 0.05 was considered significant .
RESULTS	The study included 139 male and 35 female patients between the ages of 10 and 75 years .
RESULTS	The incidence of wound infection ( p = 0.656 ) , dehiscence ( p = 0.997 ) , and incisional hernia ( p = 0.930 ) at 3 months and four years ( p = 0.910 ) was not statistically significant .
RESULTS	There was no sinus formation in groups A and B , however 2 patients of group C and 6 patients of group D did develop suture sinus ( p = 0.003 ) .
CONCLUSIONS	Suture material and technique of closure does not influence wound outcome in patients of peritonitis except for a significantly lower incidence of sinus formation when non-absorbable sutures are used .

###25099167
BACKGROUND	Clinical decision rules ( CDRs ) can be an effective tool for knowledge translation in emergency medicine , but their implementation is often a challenge .
BACKGROUND	This study examined whether the Theory of Planned Behaviour ( TPB ) could help explain the inconsistent results between the successful Canadian C-Spine Rule ( CCR ) implementation study and unsuccessful Canadian CT Head Rule ( CCHR ) implementation study .
BACKGROUND	Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time .
BACKGROUND	The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability .
BACKGROUND	The rules subsequently underwent parallel implementations at 12 Canadian hospitals , yet only the CCR was observed to significantly reduce radiography ordering rates , while the CCHR failed to have any significant impact at all .
BACKGROUND	The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules .
METHODS	Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies , before any intervention had taken place .
METHODS	The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data , and subsequently analyzed using mixed effects linear and logistic models .
RESULTS	A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey ( CCR : 122 of 181 ; CCHR : 101 of 197 ) .
RESULTS	Attitudes were significantly associated with intention in both settings ( CCR : = 0.40 ; CCHR : = 0.30 ) , as were subjective norms ( CCR : = 0.26 ; CCHR : = 0.73 ) .
RESULTS	Intention was significantly associated with actual image ordering for CCR ( OR = 1.79 ) , but not CCHR .
CONCLUSIONS	The TPB can be used to better understand processes underlying use of CDRs .
CONCLUSIONS	TPB constructs were significantly associated with intention to perform both imaging behaviours , but intention was only associated with actual behaviour for CCR , suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs .

###12126818
BACKGROUND	We did a randomised phase III trial comparing external irradiation alone and external irradiation combined with an analogue of luteinising-hormone releasing hormone ( LHRH ) to investigate the added value of long-term androgen suppression in locally advanced prostate cancer .
METHODS	Between 1987 and 1995 , 415 patients were randomly assigned radiotherapy alone or radiotherapy plus immediate androgen suppression .
METHODS	Eligible patients had T1-2 tumours of WHO grade 3 or T3-4 N0-1 M0 tumours ; the median age of participants was 71 years ( range 51-80 ) .
METHODS	In both treatment groups , 50 Gy radiation was delivered to the pelvis over 5 weeks , and 20 Gy over 2 weeks as a prostatic boost .
METHODS	Goserelin ( 3.6 mg subcutaneously every 4 weeks ) was started on the first day of irradiation and continued for 3 years ; cyproterone acetate ( 150 mg orally ) was given for 1 month starting 1 week before the first goserelin injection .
METHODS	The primary endpoint was clinical disease-free survival .
METHODS	Analyses were by intention to treat .
RESULTS	412 patients had evaluable data , with median follow-up of 66 months ( range 1-126 ) .
RESULTS	5-year clinical disease-free survival was 40 % ( 95 % CI 32-48 ) in the radiotherapy-alone group and 74 % ( 67-81 ) in the combined-treatment group ( p = 0.0001 ) .
RESULTS	5-year overall survival was 62 % ( 52-72 ) and 78 % ( 72-84 ) , respectively ( p = 0.0002 ) and 5-year specific survival 79 % ( 72-86 ) and 94 % ( 90-98 ) .
CONCLUSIONS	Immediate androgen suppression with an LHRH analogue given during and for 3 years after external irradiation improves disease-free and overall survival of patients with locally advanced prostate cancer .

###9824925
OBJECTIVE	To examine factors affecting children 's willingness to share activities with a peer presented as physically handicapped .
METHODS	Participants were 120 elementary school children randomly assigned to view a video of an ambulatory child or the same child in a wheelchair .
METHODS	They rated , on the Shared Activities Questionnaire ( SAQ ) , their own willingness ( SAQ-Self ) and their perceptions of classmates ' willingness ( SAQ-Others ) to participate in activities with the child .
RESULTS	SAQ-Self ratings were consistently higher for the peer in the wheelchair .
RESULTS	On the SAQ-Others , differences favoring the child in the wheelchair disappeared , and ratings of this child were lower than SAQ-Self ratings .
RESULTS	No interactions were found between ambulation status and age or rater gender or preference for type of shared activity .
CONCLUSIONS	Children showed highly positive intentions toward a peer in a wheelchair , but intentions attributed to classmates were less positive , which suggests `` social desirability '' influenced their own ratings .

###18725858
BACKGROUND	Cause and underlying pathogenic mechanisms of idiopathic sudden hearing loss ( ISHL ) are not fully understood , resulting in the widespread use of different polypragmatic treatment approaches , which have not been finally validated in randomized controlled trials .
BACKGROUND	Quality of life ( QoL ) can provide helpful additional information when selecting the most appropriate therapy within current options .
METHODS	In a prospective , multicenter , randomized , controlled clinical study , Rheopheresis-a method of therapeutic apheresis-was compared with a standard therapy consisting of either intravenous corticosteroids or hemodilution using pure-tone and speech audiometry .
METHODS	Quality of life as secondary outcome parameter was documented using the German Medical Outcome Short Form ( 36 ) Health Survey questionnaire .
RESULTS	Two hundred forty patients were included in this trial .
RESULTS	All three treatment options proved to be of equal efficacy regarding absolute and relative hearing gain or speech discrimination .
RESULTS	Quality of life measured in Medical Outcome Short Form ( 36 ) Health Survey scores was less than the level of the normal German population at baseline for all groups , and mentally , ISHL patients felt more impaired than patients who have chronic hearing impairment .
RESULTS	Rheopheresis treatment led to a higher QoL at the time of the follow-up visit compared with the drug-based therapies and compared with a large representative sample of the German general population .
CONCLUSIONS	Treatments leading to accelerated recovery in combination with a minimal number of therapeutic interventions , for example , Rheopheresis , seemed to have a considerable effect on QoL .
CONCLUSIONS	Because there is a dearth of evidence of efficacy for any treatment option in ISHL , QoL can provide additional information when choosing the most appropriate treatment option .

###23918953
OBJECTIVE	To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope : mindfulness-based cancer recovery ( MBCR ) and supportive-expressive group therapy ( SET ) .
METHODS	This multisite , randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR , SET , or a 1-day stress management control condition .
METHODS	MBCR focused on training in mindfulness meditation and gentle yoga , whereas SET focused on emotional expression and group support .
METHODS	Both intervention groups included 18 hours of professional contact .
METHODS	Measures were collected at baseline and after intervention by assessors blind to study condition .
METHODS	Primary outcome measures were mood and diurnal salivary cortisol slopes .
METHODS	Secondary outcomes were stress symptoms , quality of life , and social support .
RESULTS	Using linear mixed-effects models , in intent-to-treat analyses , cortisol slopes were maintained over time in both SET ( P = .002 ) and MBCR ( P = .011 ) groups relative to the control group , whose cortisol slopes became flatter .
RESULTS	Women in MBCR improved more over time on stress symptoms compared with women in both the SET ( P = .009 ) and control ( P = .024 ) groups .
RESULTS	Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group ( P = .005 ) and in social support compared with the SET group ( P = .012 ) .
CONCLUSIONS	In the largest trial to date , MBCR was superior for improving stress levels , quality of life and social support [ CORRECTED ] for distressed survivors of breast cancer .
CONCLUSIONS	Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition .
CONCLUSIONS	The clinical implications of this finding require further investigation .

###24171182
OBJECTIVE	To investigate the effectiveness of single and concomitant treatment of migraine and temporomandibular disorders ( TMD ) in women with the comorbidity .
METHODS	Eligible female patients met International Classification of Headache Disorders , second edition ( ICHD-2 ) criteria for migraine with or without aura and the Research Diagnostic Criteria for myofascial TMD ( Grade ll or lll ) .
METHODS	After a run-in period ( 30 days ) , women with both migraine and TMD were enrolled into a four-arm , double-blind , placebo-controlled , factorial study testing the separate and joint effects of a migraine treatment ( propranolol 90 mg ) and a TMD treatment ( stabilization splint [ SS ] ) in four groups of patients .
METHODS	The four treatment groups were propranolol and SS ( n = 22 ) ; propranolol placebo and SS ( n = 23 ) ; propranolol and non-occlusal splint ( NOS ) ( n = 23 ) ; and propranolol placebo and NOS ( n = 21 ) .
METHODS	The primary endpoint for migraine was change in headache days from baseline to the third month , and the secondary endpoint was change in days with at least moderate headache in the same period .
METHODS	The TMD endpoints included pain threshold and mandibular vertical range of motion .
METHODS	Data were analyzed using analysis of variance ( ANOVA , Dunn 's post-hoc test ) or Kruskal-Wallis test .
RESULTS	For the primary endpoint , in intention-to-treat ( ITT ) analyses ( n = 94 ) , propranolol and SS were associated with a nonsignificant reduction in the number of headache days , relative to all other groups .
RESULTS	For per-protocol ( PP ) Completer analyses ( n = 89 ) , differences in the number of headache days reached significance ( P < .05 ) .
RESULTS	The propranolol and SS group was significantly superior to the other groups on all other headache endpoints and in disability , in both ITT and PP analyses .
RESULTS	No significant differences among groups were seen for the TMD parameters .
CONCLUSIONS	In women with TMD and migraine , migraine significantly improved only when both conditions were treated .
CONCLUSIONS	The best treatment choice for TMD pain in women with migraine is yet to be defined .

###18373223
BACKGROUND	To investigate the risks and possible benefits of routine versus intensive insulin therapy , assessed by the frequency of hypoglycemic events defined as a glucose concentration less than 80 mg/dl ( < 4.44 mmol/l ) in patients admitted to the intensive care unit ( ICU ) after severe traumatic brain injury ( TBI ) .
RESULTS	Ninety-seven patients admitted after severe TBI , were enrolled and randomly assigned to two groups of target glycemia .
RESULTS	Insulin was infused at conventional rates when blood glucose levels exceeded 220 mg/dl ( 12.22 mmol/l ) or at intensive rates , to maintain glycemia at 80-120 mg/dl ( 4.44-6 .66 mmol/l ) .
RESULTS	The following primary and outcome variables were measured during follow-up : hypoglycemic episodes , duration of ICU stay , infection rate , and 6-month mortality and neurologic outcome measured using the Glasgow Outcome Scale ( GOS ) .
RESULTS	Episodes of hypoglycemia ( defined as blood glucose < 80 mg/dl or 4.44 mmol/l ) were significantly higher in patients receiving intensive insulin therapy : median ( min-max ) conventional insulin therapy 7 ( range 0-11 ) vs. intensive insulin therapy 15 ( range 6-33 ) ; P < 0.0001 .
RESULTS	Duration of ICU stay was shorter in patients receiving intensive insulin therapy ( 7.3 vs. 10.0 days ; P < 0.05 ) ; while infection rates during ICU stay ( 25.0 % vs. 38.8 % , P = 0.15 ) , and GOS scores and mortality at 6 months were similar in the two groups .
CONCLUSIONS	Intensive insulin therapy significantly increases the risk of hypoglycemic episodes .
CONCLUSIONS	Even though patients receiving intensive insulin therapy have shorter ICU stays and infection rates similar to those receiving conventional insulin therapy , both groups have similar follow-up mortality and neurologic outcome .
CONCLUSIONS	Hence if intensive insulin therapy is to be used , great effort must be taken to avoid hypoglycemia .

###22515895
BACKGROUND	The purpose of this in vitro study was to assess the influence of MetaSEAL and AH Plus on the resistance to vertical root fracture of endodontically treated teeth when either the matched-taper single-cone or lateral condensation technique was used .
METHODS	Ninety extracted single-canal mandibular premolar teeth were sectioned , leaving a standard root length of 13 mm .
METHODS	The buccolingual and mesiodistal diameters were measured , and the teeth were randomly divided into 6 groups ( n = 15 ) .
METHODS	There were no statistically significant differences between the groups in terms of the diameters .
METHODS	In group 1 , no instrumentation or obturation was performed .
METHODS	The rest of the roots were chemomechanically prepared with nickel-titanium ProTaper rotary instruments up to size F3 at the working length .
METHODS	Group 2 was left unobturated .
METHODS	Groups 3 and 4 were obturated with AH Plus used with the matched-taper single-cone and lateral condensation techniques , respectively .
METHODS	In groups 5 and 6 , MetaSEAL was used instead of AH Plus .
METHODS	All of the roots were mounted vertically in self-curing acrylic resin blocks that exposed 8 mm of the coronal part .
METHODS	Then the roots were subjected to a vertical loading force ( 1 mm/min ) .
METHODS	The force required to produce a fracture was recorded in newtons .
METHODS	The data were analyzed by using Kruskal-Wallis and post hoc Dunn multiple comparison tests ( P < .05 ) .
RESULTS	Although we did not detect statistical significance , there was a substantial difference between the fracture resistance values of the intact and instrumented but not obturated roots .
RESULTS	The groups in which AH Plus and MetaSEAL were used with the matched-taper single-cone technique showed significantly higher fracture resistance values than the instrumented but not obturated roots ( P < .05 ) .
RESULTS	There were no significant differences between the groups submitted to the matched-taper single-cone technique .
RESULTS	The force required to fracture the roots in the group treated with AH Plus and the lateral condensation technique was similar to that required to fracture intact roots , whereas the group treated with MetaSEAL and the lateral condensation technique revealed comparable values to the instrumented but not obturated roots .
CONCLUSIONS	When used with the matched-taper single-cone technique , MetaSEAL and AH Plus have the potential to reinforce endodontically treated teeth .

###11351929
BACKGROUND	Prepulse inhibition ( PPI ) of the startle response refers to an attenuation in response to a strong stimulus ( pulse ) if this is preceded shortly by a weak non-startling stimulus ( prepulse ) .
BACKGROUND	Patients with schizophrenia have repeatedly been found to show reduced PPI when compared to healthy people .
BACKGROUND	Anticholinergic drugs are often used to control extrapyramidal symptoms induced by antipsychotic medication in schizophrenic patients .
BACKGROUND	Antipsychotic medication , in particular with atypical drugs , has been shown to improve a range of cognitive functions and normalize PPI deficits in schizophrenia , whereas anticholinergic drugs disrupt cognitive functions in both normal and schizophrenic populations and also impair PPI in experimental animals .
BACKGROUND	No previous study has investigated the effects of anticholinergic drugs on human PPI .
OBJECTIVE	This study determined the effects of procyclidine , an anticholinergic drug , on PPI in healthy male volunteers , employing a double-blind placebo-controlled cross-over design .
METHODS	Subjects underwent testing for PPI on two occasions : once after the oral administration of a placebo and once after the oral administration of procyclidine in two separate experiments .
METHODS	Experiment 1 examined the effects of 10 mg procyclidine , whereas experiment 2 examined the effects of 15 mg procyclidine .
RESULTS	Procyclidine at a 10 mg dose , as compared to placebo , had no effect on PPI , but caused impairments at a 15 mg dose .
RESULTS	In both experiments , procyclidine reduced response amplitude over the pulse-alone trials and heart rate 1-2 h post-administration .
CONCLUSIONS	PPI of the human acoustic startle response is modulated by procyclidine .
CONCLUSIONS	The use of anticholinergics needs to be considered in PPI studies in schizophrenia .

###16553341
OBJECTIVE	To compare the effectiveness of propofol versus sevoflurane associated with remifentanil on the maintenance of anesthesia and on recovery in patients undergoing elective supratentorial craniotomy .
METHODS	Prospective randomized trial enrolling 90 patients scheduled for excision of a brain neoplasm .
METHODS	All received an infusion of remifentanil at a dose of 0.5 microg x Kg ( -1 ) x min ( -1 ) until tracheal intubation and then 0.25 microg x Kg ( -1 ) x min ( -1 ) during surgery .
METHODS	Induction was achieved with propofol and anesthesia was maintained with either sevoflurane at a maximum alveolar concentration of 0.4 ( 45 patients ) or propofol by target controlled infusion at a concentration of 2.5 microg x mL ( -1 ) ( 45 patients , group P ) .
METHODS	Variables assessed were hemodynamic stability during anesthesia and times and quality of recovery from anesthesia ( eye opening , initiation of spontaneous ventilation , extubation , cough reflex , and temporal and spacial orientation 3 minutes after extubation .
METHODS	During the first 24 hours after surgery , pain intensity was evaluated on a verbal visual analog scale ( VAS ) and the incidence of nausea and vomiting was recorded .
RESULTS	Times until eye opening upon request and until extubation were significantly shorter in the sevoflurane group than in the propofol group : 3.7 ( SD , 1.2 ) minutes vs 5 ( 3.1 ) minutes , respectively , for eye opening and 6.6 ( 1.2 ) minutes vs 8.1 ( 3.3 ) minutes for extubation ( P < 0.01 ) .
RESULTS	The incidence of nausea and vomiting was significantly higher in the sevoflurane group ( 40 % vs 13 % , respectively , P < 0.01 ) .
CONCLUSIONS	Combining remifentanil with propofol or with sevoflurane provides satisfactory anesthesia during elective supratentorial craniotomy to remove a brain neoplasm .
CONCLUSIONS	Hemodynamic stability is appropriate and recovery from anesthesia is rapid .

###23396375
OBJECTIVE	S-1 is an oral anticancer fluoropyrimidine formulation consisting of tegafur , 5-chloro-2 ,4 - dihydroxypyridine and potassium oxonate .
OBJECTIVE	The aim of this study was to evaluate the pharmacokinetics and bioequivalence of a newly developed generic formulation of S-1 in Chinese cancer patients in comparison with the branded reference formulation of S-1 .
METHODS	A single-dose , randomized-sequence , open-label , two-way self-crossover study was conducted in 30 Chinese cancer patients .
METHODS	The subjects alternatively received the two formulations ( 40 mg/m ( 2 ) , po ) with a 7-d interval .
METHODS	Plasma concentrations of FT , CDHP , Oxo , and 5-Fu were determined using LC-MS/MS .
METHODS	Pharmacokinetic parameters , including Cmax , Tmax , t1/2 , AUC0-t , and AUC0 - were determined using non-compartmental models with DAS2 .0 software .
METHODS	Bioequivalence of the two formulations were to be evaluated according to 90 % CIs for the log-transformed ratios of AUC and Cmax of S-1 .
METHODS	Adverse events were evaluated through monitoring the symptom , physical and laboratory examinations , ECGs and subject interviews .
RESULTS	The mean values of Cmax , AUC0-t , and AUC0 - of FT , 5-Fu , CDHP , and Oxo for the two formulations had no significant differences .
RESULTS	The 90 % CIs for natural log-transformed ratios of Cmax , AUC0-t , and AUC0 - were within the predetermined bioequivalence acceptance limits .
RESULTS	A total of 11 mild adverse events , including fatigue , nausea and vomiting , anorexia , diarrhea and myelosuppression , were observed , and no serious and special adverse events were found .
CONCLUSIONS	The newly developed generic formulation and reference formulation of S-1 have similar pharmacokinetics with one dose ( 40 mg/m ( 2 ) ) in Chinese cancer patients .
CONCLUSIONS	Both the formulations of S-1 are well tolerated .

###18283141
OBJECTIVE	To examine the effectiveness of e-mail communication between surgeon and patient prior to elective surgery .
METHODS	Prospective randomized study .
METHODS	Tertiary referral center .
METHODS	One hundred consecutive patients presenting for consultation prior to undergoing thyroid or parathyroid surgery .
METHODS	All were randomized to either receiving an information sheet promoting e-mail communication as the preferred method of communication ( group E ) or a standard information sheet ( group S ) .
METHODS	( 1 ) Use of communication with the surgeon outside of the booked preoperative and postoperative consultation and ( 2 ) satisfaction questionnaire .
RESULTS	Overall , 26 of 100 patients ( 26 % ) initiated additional perioperative communication with the surgeon , 19 of 50 ( 38 % ) in group E and 7 of 50 ( 14 % ) in group S ( P < .001 ) .
RESULTS	Of those who initiated communication , 22 of 26 ( 84 % ) did so by e-mail ; 3 ( 12 % ) , by fax ; and 1 ( 4 % ) , by telephone .
RESULTS	For patients using e-mail , 18 of 22 ( 81 % ) were in group E and 4 of 22 ( 18 % ) , in group S ( P < .02 ) .
RESULTS	Overall , 34 e-mails were sent by 22 patients in the study group .
RESULTS	Most e-mails sent focused on only 1 issue ; however , some patients raised multiple issues , with the most being 4 issues in a single e-mail .
RESULTS	There were no differences in any of the outcome measures in relation to patient satisfaction with communication .
CONCLUSIONS	Despite concerns about potential medicolegal issues and other disadvantages , providing patients undergoing elective surgery with e-mail access to their surgeon results in improved levels of communication without any demonstrated impairment of satisfaction with outcomes .

###20613689
OBJECTIVE	Anesthetic preoperative evaluation clinics ( APECs ) are relatively new institutions .
OBJECTIVE	Although cost effective , APECs have not been universally adopted in Europe .
OBJECTIVE	The aim of this study was to compare preoperative anesthetic assessment in wards with an APEC , assessing time , information gain , patient satisfaction and secondary costs .
METHODS	Two hundred and seven inpatients were randomized to be assessed at the APEC or on the ward by the same two senior anesthetists .
METHODS	The outcomes measured were the length of time for each consultation , the amount of information passed on to patients and the level of patient satisfaction .
METHODS	The consultation time was used to calculate impact on direct costs .
METHODS	A multivariate analysis was conducted to detect confounding variables .
RESULTS	Ninety-four patients were seen in the APEC , and 78 were seen on the ward .
RESULTS	The total time for the consultation was shorter for the APEC ( mean 8.4 minutes [ P < 0.01 ] ) , and we calculated savings of 6.4 Euro per patient .
RESULTS	More information was passed on to the patients seen in the APEC ( P < 0.01 ) .
RESULTS	The general satisfaction scores were comparable between groups .
RESULTS	A multivariate analysis found that the consultation time was significantly influenced by the type of anesthesia , the magnitude of the operation and the location of the consultation .
RESULTS	Gain in information was significantly influenced by age , education and the location of the visit .
CONCLUSIONS	The APEC reduced consultation times and costs and had a positive impact on patient education .
CONCLUSIONS	The cost savings are related to personnel costs and , therefore , are independent of other potential savings of an APEC , whereas global patient satisfaction remains unaltered .

###12736566
BACKGROUND	A prospective randomized multi-center study was undertaken for 2 years and 3 months from November 1982 , with the aim of examining the significance of using a combination of futraful ( FT ) and tamoxifen ( TAM ) for postoperative adjuvant therapy for stage II breast cancer after curative surgery .
METHODS	Patients were divided into two groups and received one of the following treatment protocols : treatment A , intravenous administration of doxorubicin ( DOX ) 20 mg/body on the day of surgery and 10 mg/body the next day , followed by oral FT 600 mg/day for 2 years from the 14th day after surgery ; treatment B , the same pattern of DOX administration followed by combined therapy with FT and TAM 20 mg/day for 2 years .
METHODS	The number of patients was 428 ( treatment A 210 and treatment B 218 ) , of whom 418 ( 97.7 % ) were followed for 10 years for analysis .
RESULTS	Significantly higher 5 - and 10-year overall survival ( OS ) rates were observed with treatment B compared with treatment A ( p = 0.0101 and 0.0219 ) .
RESULTS	Node-positive patients appeared to derive more benefit from TAM than node-negative patients .
RESULTS	The difference in 10-year OS between treatment A and treatment B was more evident than that of the 5-year OS in patients with more than 4 positive nodes ( p = 0.0313 vs. 0.0479 ) .
RESULTS	No increase in adverse reactions was seen as a result of combining TAM with FT.
CONCLUSIONS	The study results demonstrate that for stage II breast cancer concomitant administration of FT and TAM is superior to FT alone for postoperative adjuvant therapy , and administration of TAM for 2 years may contribute not only to 5-year survival rates but also to 10-year survival rates of node-positive patients .

###17267789
OBJECTIVE	The purpose of this study was to determine the efficacy of panic-focused psychodynamic psychotherapy relative to applied relaxation training , a credible psychotherapy comparison condition .
OBJECTIVE	Despite the widespread clinical use of psychodynamic psychotherapies , randomized controlled clinical trials evaluating such psychotherapies for axis I disorders have lagged .
OBJECTIVE	To the authors ' knowledge , this is the first efficacy randomized controlled clinical trial of panic-focused psychodynamic psychotherapy , a manualized psychoanalytical psychotherapy for patients with DSM-IV panic disorder .
METHODS	This was a randomized controlled clinical trial of subjects with primary DSM-IV panic disorder .
METHODS	Participants were recruited over 5 years in the New York City metropolitan area .
METHODS	Subjects were 49 adults ages 18-55 with primary DSM-IV panic disorder .
METHODS	All subjects received assigned treatment , panic-focused psychodynamic psychotherapy or applied relaxation training in twice-weekly sessions for 12 weeks .
METHODS	The Panic Disorder Severity Scale , rated by blinded independent evaluators , was the primary outcome measure .
RESULTS	Subjects in panic-focused psychodynamic psychotherapy had significantly greater reduction in severity of panic symptoms .
RESULTS	Furthermore , those receiving panic-focused psychodynamic psychotherapy were significantly more likely to respond at treatment termination ( 73 % versus 39 % ) , using the Multicenter Panic Disorder Study response criteria .
RESULTS	The secondary outcome , change in psychosocial functioning , mirrored these results .
CONCLUSIONS	Despite the small cohort size of this trial , it has demonstrated preliminary efficacy of panic-focused psychodynamic psychotherapy for panic disorder .

###11843508
OBJECTIVE	The changes in geometry of the aortic root during the cardiac cycle are thought to be essential for optimal valve function , both in terms of leaflet stress and dynamic behavior .
OBJECTIVE	Using cardiac magnetic resonance ( CMR ) , the study aim was to determine aortic root distensibility of the homograft ( group H ) and the Medtronic Freestyle xenograft ( group F ) after aortic root replacement , from a prospective randomized trial .
METHODS	CMR was performed in 15 patients ( six homografts , nine Freestyle ) at six months and one year after surgery .
METHODS	Percentage change in aortic radius ( PCR ) and pressure strain elastic modulus ( PSEM ) were measured as indices of distensibility , and results related to left ventricular mass ( LVM ) .
RESULTS	At six months after surgery , mean PCR was 12 + / -2.5 in group H and 12.9 + / -6.1 in group F ( p = NS ) , and PSEM was 428.5 + / -69.8 and 493.5 + / -72.7 g/cm2 , respectively ( p = NS ) .
RESULTS	PCR was reduced to 10 + / -1.7 % in group H , and by 8.5 + / -2.8 % in group F ( p = NS ) , while PSEM was increased to 520.5 + / -87.3 and 825 + / -420.4 , respectively ( p = NS ) at the one-year follow up .
RESULTS	Regression analysis showed a correlation between PCR and LVM ( r = 0.52 , p = 0.08 ) and LVM index ( r = 0.46 , p = 0.14 ) , respectively .
RESULTS	In addition , there was a relationship between PSEM , LVM and LVM index , suggesting that the stiffer the root wall , the higher the postoperative LVM .
CONCLUSIONS	Up to one year after aortic root replacement , the wall of both the allogenic and xenogenic valves retained near-normal distensibility .
CONCLUSIONS	For the first time , a correlation was demonstrated between the elastic properties of the aortic root and LVM .
CONCLUSIONS	The longer-term behavior and clinical implications of these findings require further investigation .

###11776446
OBJECTIVE	Antidromic conduction studies in the human median nerve were used to assess the neurophysiological effects of irradiation of the skin overlying the nerve using a novel treatment unit comprising a multisource monochromatic infrared diode array ( Equilight , Denver , CO ) .
METHODS	Healthy human volunteers ( n = 40 ) were recruited and randomly allocated to one of four groups : control , placebo , or one of two treatment groups ( 1.7 and 4.0 J/cm2 ) .
METHODS	After baseline recordings of negative peak latency ( NPL ) were completed on the nondominant arm , subjects were treated according to group allocation .
METHODS	Recordings were subsequently repeated at 5-min intervals over a 45-min period .
RESULTS	Analysis of negative peak latency difference scores ( ANOVA ) demonstrated significant differences in NPL between groups and over time ( p < 0.05 ) .
RESULTS	While in the control and placebo groups NPL values remained relatively stable , in the two treatment groups such values decreased marginally , with the greatest effects observed in the 4.0 J/cm2 group ( e.g. , at 5 min , differences in NPL [ mean + / - SEM ] : control group , 0.02 + / -0.03 msec ; treatment group 2 , 4 J/cm2 , -0.07 + / -0.03 msec ) .
RESULTS	Similar significant differences were observed in skin temperature ; correlation analysis indicated a weak ( but expected ) positive linear relationship between skin temperature and nerve conduction velocity ( r = 0.125 ) .
CONCLUSIONS	These results suggest that irradiation at the parameters and under the conditions used here produce a direct neurophysiological effect .
CONCLUSIONS	The magnitude of such effects are in keeping with previous findings using single source arrays at higher radiant exposures or thermal effects of the treatment unit .

###19481812
OBJECTIVE	To determine the efficacy and safety of periocular triamcinolone acetonide ( 40 mg ) for the prevention of macular edema in patients undergoing plaque radiotherapy for uveal melanoma .
METHODS	Prospective , randomized , controlled clinical trial .
METHODS	One-hundred sixty-three patients with newly diagnosed uveal melanoma undergoing iodine 125 plaque radiotherapy were entered into the study .
METHODS	Fifty-five patients were randomized to the control group and 108 to the triamcinolone group .
METHODS	Eighteen-month data were available for 143 ( 88 % ) of the 163 patients .
METHODS	Periocular injection of triamcinolone acetonide ( 40 mg in 1 ml ) at the time of plaque radiotherapy and 4 months and 8 months later .
METHODS	Optical coherence tomography was performed at each patient evaluation .
METHODS	Optical coherence tomography-evident macular edema , moderate vision loss , and poor final visual acuity .
RESULTS	Optical coherence tomography-evident macular edema occurred significantly less often in the triamcinolone group compared with the control group up to 18 months after plaque radiotherapy ( hazard estimate , 0.45 ; 95 % confidence interval , 0.19-0 .70 ; P = 0.001 ) .
RESULTS	At the 18-month follow-up , moderate vision loss ( loss of 3 lines or more of best-corrected visual acuity [ BCVA ] ) and severe vision loss ( BCVA < 5/200 Snellen ) occurred significantly less frequently in the triamcinolone group than in the control group ( 31 % vs. 48 % [ P = 0.039 ] and 5 % vs. 15 % [ P = 0.048 ] , respectively ) .
RESULTS	Rates of elevated intraocular pressure and cataract progression were similar in both groups .
CONCLUSIONS	Periocular triamcinolone is beneficial in reducing the risk of macular edema up to 18 months after plaque radiotherapy for uveal melanoma and significantly reduces the risk of moderate vision loss and poor visual acuity in these patients .

###8583171
OBJECTIVE	To establish the reliability of the BROM II device for measuring lumbar mobility in the sagittal , coronal and transverse planes and its validity against the double inclinometer method .
METHODS	Blind intra - and interexaminer reliability and concurrent validity .
METHODS	Interexaminer reliability was determined between two examiners .
METHODS	Chiropractice teaching college .
METHODS	Forty-seven asymptomatic chiropractic students ( 27 men and 20 women , age range 18 to 38 yr ) .
METHODS	Lumbar mobility measurement in degrees using the BROM II and double inclinometer techniques .
RESULTS	Intraclass correlation coefficients ( ICC ) showed good intra - and interexaminer reliability of the BROM II for flexion ( 0.91 and 0.77 , respectively ) and lateral flexion ( 0.91 and 0.85 respectively ) .
RESULTS	Less support was given to the reliability of the instrument in extension ( 0.63 and 0.35 , respectively ) and rotation ( 0.57 and 0.36 respectively ) .
RESULTS	Concurrent validity of the BROM II and double inclinometer methods was partially supported ( ICC in all planes range from 0.27 to 0.75 ) .
CONCLUSIONS	The BROM II was found to be a reliable instrument in the measurement of lumbar mobility in the sagittal ( flexion ) and coronal planes .
CONCLUSIONS	However , before this device can be recommended as an assessment tool in clinical practice or clinical trials , further investigation into its reliability in a symptomatic group of patients is required .
CONCLUSIONS	( J Manipulative Physiol Ther 1995 ; 18:497 -502 ) .

###21943482
BACKGROUND	Public health authorities have recognized lack of hand hygiene in hospitals as one of the important causes of preventable mortality and morbidity at population level .
BACKGROUND	The implementation strategy ACCOMPLISH ( Actively Creating COMPLIance Saving Health ) targets both individual and environmental determinants of hand hygiene .
BACKGROUND	This study aims to evaluate the cost-effectiveness of a multicomponent implementation strategy aimed at the reduction of healthcare associated infections in Dutch hospital care , by promotion of hand hygiene .
METHODS	The ACCOMPLISH package will be evaluated in a two-arm cluster randomised trial in 16 hospitals in the Netherlands , in one intensive care unit and one surgical ward per hospital .
METHODS	A multicomponent package , including e-learning , team training , introduction of electronic alcohol based hand rub dispensers and performance feedback .
METHODS	The primary outcome measure will be the observed hand hygiene compliance rate , measured at baseline and after 6 , 12 and 18 months ; as a secondary outcome measure the prevalence of healthcare associated infections will be measured at the same time points .
METHODS	Process indicators of the intervention will be collected pre and post intervention .
METHODS	An ex-post economic evaluation of the ACCOMPLISH package from a healthcare perspective will be performed .
METHODS	Multilevel analysis , using mixed linear modelling techniques will be conducted to assess the effect of the intervention strategy on the overall compliance rate among healthcare workers and on prevalence of healthcare associated infections .
METHODS	Questionnaires on process indicators will be analysed with multivariable linear regression , and will include both behavioural determinants and determinants of innovation .
METHODS	Cost-effectiveness will be assessed by calculating the incremental cost-effectiveness ratio , defined here as the costs for the intervention divided by the difference in prevalence of healthcare associated infections between the intervention and control group .
CONCLUSIONS	This study is the first RCT to investigate the effects of a hand hygiene intervention programme on the number of healthcare associated infections , and the first to investigate the cost-effectiveness of such an intervention .
CONCLUSIONS	In addition , if the ACCOMPLISH package proves successful in improving hand hygiene compliance and lowering the prevalence of healthcare associated infections , the package could be disseminated at ( inter ) national level .
BACKGROUND	NTR2448 .

###15824215
OBJECTIVE	To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years .
METHODS	At 49 clinical sites , 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group ( 2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years ) or an optical correction group ( optical correction alone ) .
METHODS	Patients whose amblyopic eye acuity improved 10 or more letters ( > or = 2 lines ) by 24 weeks were considered responders .
RESULTS	In the 7 - to 12-year-olds ( n = 404 ) , 53 % of the treatment group were responders compared with 25 % of the optical correction group ( P < .001 ) .
RESULTS	In the 13 - to 17-year-olds ( n = 103 ) , the responder rates were 25 % and 23 % , respectively , overall ( adjusted P = .22 ) but 47 % and 20 % , respectively , among patients not previously treated with patching and/or atropine for amblyopia ( adjusted P = .03 ) .
RESULTS	Most patients , including responders , were left with a residual visual acuity deficit .
CONCLUSIONS	Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years , although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia .
CONCLUSIONS	For patients aged 7 to 12 years , prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated .
CONCLUSIONS	For patients 13 to 17 years , prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching .
CONCLUSIONS	We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued ; therefore , conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment .

###15809382
BACKGROUND	Analgesics for children with acute abdominal pain are often withheld for fear that they might mask physical examination findings and thus might be unsafe .
BACKGROUND	This viewpoint has been challenged recently .
OBJECTIVE	To evaluate the effects of buccal oxycodone on pain relief , physical examination findings , diagnostic accuracy , and final clinical outcomes in children with acute abdominal pain .
METHODS	Prospective , randomized , double-blind , and placebo-controlled trial between December 2001 and November 2003 .
METHODS	University teaching hospital in Finland .
METHODS	Patients A total of 104 children aged 4 to 15 years with abdominal pain of less than 7 days ' duration were screened , and 63 children with pain scores of 5 or higher on a 10-cm visual analog scale were eligible for the trial .
METHODS	Intervention Children were randomized to receive buccally either 0.1 mg/kg ( -1 ) of oxycodone hydrochloride ( n = 32 ) or the same volume of normal saline ( n = 31 ) .
METHODS	The same surgeon described the physical findings and indicated a provisional diagnosis and a provisional disposition before the children received the study medication and at 1 hour and 3.5 hours after initial dosing .
METHODS	Pain scores were recorded at baseline and every 30 minutes for 3.5 hours after the first study drug administration .
METHODS	Pain intensity difference , presence or absence of abdominal guarding , and diagnostic accuracy .
RESULTS	The demographic characteristics , initial pain scores , and physical signs and symptoms were similar between the 2 groups .
RESULTS	Both study drugs were associated with decreasing pain scores .
RESULTS	The summed pain intensity difference over 7 observations was significantly greater in the oxycodone group , 22 + / - 18 cm , than in the placebo group , 9 + / - 12 cm ( mean difference 13 cm , with a 95 % confidence interval of 2-24 cm ; P = .04 ) .
RESULTS	The diagnostic accuracy increased from 72 % to 88 % in the oxycodone group and remained at 84 % in the placebo group after study drug administration .
RESULTS	Laparotomy was performed in 17 patients in the oxycodone group and in 14 patients in the placebo group .
RESULTS	Four patients without appendicitis underwent exploratory laparotomy in each group .
RESULTS	One patient in the placebo group was initially diagnosed as having nonspecific abdominal pain , but at 14 hours , she was operated on for appendiceal perforation .
CONCLUSIONS	Early administration of buccal oxycodone provides a significant pain relief to children with acute abdominal pain , without adversely altering the clinical signs or obscuring the surgical diagnosis .

###22193788
OBJECTIVE	A randomized cluster controlled trial tested the hypothesis that weekly feedback to clinicians would improve the effectiveness of home-based mental health treatment received by youths in community settings .
METHODS	Youths , caregivers , and clinicians at 28 sites in ten states completed assessments of the youths ' symptoms and functioning every other week .
METHODS	Clinicians at 13 sites were provided with weekly feedback about the assessments , and clinicians at 15 sites received feedback every 90 days .
METHODS	Data were collected from June 1 , 2006 , through December 31 , 2008 .
METHODS	Intent-to-treat analyses were conducted with hierarchical linear modeling of data provided by youths , caregivers , and clinicians .
RESULTS	Assessments by youths , caregivers , and clinicians indicated that youths ( N = 173 ) treated at sites where clinicians could receive weekly feedback improved faster than youths ( N = 167 ) treated at sites where clinicians did not receive weekly feedback .
RESULTS	A dose-response analysis showed even stronger effects when clinicians viewed more feedback reports .
CONCLUSIONS	Routine measurement and feedback can be used to improve outcomes for youths who receive typical home-based services in the community .

###12950426
BACKGROUND	Lumiracoxib ( Prexige ) is a cyclooxygenase-2 ( COX-2 ) selective inhibitor .
OBJECTIVE	To compare the gastroduodenal tolerability of lumiracoxib with placebo and naproxen in a randomized , parallel-group , double-blind study .
METHODS	: Sixty-five healthy male subjects were randomized to receive 8 days ' dosing with lumiracoxib 200 mg twice daily ( b.d. ) ( n = 21 ) , placebo ( n = 22 ) or naproxen 500 mg b.d. ( n = 22 ) .
METHODS	Endoscopic evaluations of gastric and duodenal mucosae were conducted at baseline and after 8 days ' dosing .
METHODS	Serum was assayed for ex-vivo concentrations of thromboxane B2 ( TxB2 ) to determine cyclooxygenase-1 ( COX-1 ) inhibitory activity .
RESULTS	Sixty subjects ( 20 per group ) completed the study .
RESULTS	No gastroduodenal erosions were observed in subjects receiving lumiracoxib .
RESULTS	Thirteen subjects receiving naproxen developed duodenal erosions .
RESULTS	At the gastric site , one subject in each of the naproxen and placebo groups had erosions ; one subject receiving naproxen also developed a small asymptomatic gastric ulcer .
RESULTS	Gastrointestinal adverse events accounted for 42.3 % of all adverse events , occurring in 3/21 , 4/22 and 6/22 of the lumiracoxib , placebo and naproxen groups , respectively .
RESULTS	TxB2 levels were similar for patients receiving placebo or lumiracoxib , but were reduced by > 95 % in patients receiving naproxen , compared with placebo .
CONCLUSIONS	Multiple doses of lumiracoxib resulted in gastroduodenal tolerability similar to placebo and superior to naproxen .

###12534959
OBJECTIVE	To evaluate the efficacy of oral calcium supplements in HIV-infected patients with nelfinavir ( NFV ) - associated diarrhoea , and to investigate the influence on the pharmacokinetics of nelfinavir and the active metabolite M8 .
METHODS	An open-label prospective trial with enrolment of 15 patients with NFV-associated diarrhoea .
METHODS	Study subjects received either calcium carbonate or calcium gluconate/calcium carbonate in addition to highly active antiretroviral therapy ( HAART ) , and were randomized to ( i ) calcium supplements for 14 days followed by 14 without calcium supplements , or ( ii ) 14 days without calcium supplements followed by calcium supplements for 14 days .
METHODS	Clinical endpoint was the severity of diarrhoea , graded and summarized for the specific 14 day-period .
METHODS	In the pharmacokinetic evaluation concentrations of NFV and M8 were measured before morning dosing , and 3 h after dosing .
RESULTS	Nine patients were treated with calcium carbonate , and six with calcium gluconate/calcium carbonate .
RESULTS	In the paired analysis , neither of the groups had a significant improvement in diarrhoea score when treated with calcium supplements ( P = 0.34 and 0.46 , respectively ) .
RESULTS	We found no significant differences in the concentrations of NFV and M8 between the calcium and control periods .
CONCLUSIONS	Oral calcium supplements did not significantly improve nelfinavir-associated diarrhoea .
CONCLUSIONS	In the pharmacokinetic analysis calcium supplements did not induce major alterations in plasma concentrations of NFV and M8 .

###16571285
OBJECTIVE	To observe the effect of Shenfu injection ( SFI ) in treating non small cell lung cancer ( NSCLC ) patients on quality of life with gemcitabine ( GEM ) plus cisplatin ( GP ) regimen .
METHODS	Thirty-four patients were ready to receive GP regimen chemotherapy for treating NSCLC disease , according to lot-drawing , they were divided into SFI pre-treatment group ( 18 cases ) and SFI post-treatment group ( 16 cases ) .
METHODS	SFI pre-treatment group : During the first treatment course , chemotherapy was begun with SFI 60 ml , intravenous dripping on the 3rd day , once daily , consecutively for 10 days ; on the 1st day , GP regimen ( GEM 1250 mg/m ( 2 ) , intravenous dripping , on the 1st and 8th day ; cisplatin 70 mg/m ( 2 ) on the 2nd day ; 21 days as one cycle ) was carried out ; in the second treatment course GP regimen was merely given to serve as the self-control .
METHODS	SFI post-treatment group : the medicament sequence order was reversed from that of pre-treatment group .
METHODS	Using dual international quality of life ( QOL ) scores , the effect of SFI on the patients ' QOL was observed through randomized self pre - and post-crossover control .
RESULTS	The QOL in the 34 patients after being treated by SFI in combination with GP chemotherapy regimen in one group , and GP chemotherapy regimen alone in the other , was improved in different degrees , with significant difference ( P < 0.01 ) ; comparison of SFI combined with GP chemotherapy regimen with GP chemotherapy alone showed that QOL in patients was significantly different ( P < 0.01 ) .
CONCLUSIONS	SFI could improve QOL in patients with NSCLC who were treated with GP regimen .

###9755260
OBJECTIVE	To determine the practicality and safety of head cooling with mild or minimal systemic hypothermia in term neonates with moderate to severe hypoxic-ischemic encephalopathy .
METHODS	Study group infants > / = 37 weeks ' gestation , who had an umbilical artery pH < / = 7.09 or Apgars < / = 6 at 5 minutes , plus evidence of encephalopathy .
METHODS	Infants with major congenital abnormalities were excluded .
METHODS	TRAIL DESIGN : Infants were randomized to either no cooling ( controls ; rectal temperature = 37.0 + / - 0.2 degreesC , n = 10 ) or sequentially , either minimal systemic cooling ( rectal temperature = 36.3 + / - 0.2 degreesC , n = 6 ) or mild systemic cooling ( rectal temperature = 35.7 + / - 0.2 degreesC , n = 6 ) .
METHODS	Head cooling was accomplished by circulating water at 10 degreesC through a coil of tubing wrapped around the head for up to 72 hours .
METHODS	All infants were warmed by servo-controlled overhead heaters to maintain the allocated rectal temperature .
METHODS	The rectal , fontanelle , and nasopharyngeal temperatures were continuously monitored .
RESULTS	From January 1996 to October 1997 , 22 term infants were randomized from 2 to 5 hours after birth .
RESULTS	All infants showed a metabolic acidosis at delivery , with similar umbilical artery pH in the control group ( mean + / - standard deviation , 6.79 + / - 0.25 ) , minimal cooling group ( 6.98 + / - 0.21 ) , and mild cooling group ( 6.93 + / - 0.11 ) , and depressed Apgar scores at 5 minutes in the control group ( 4.5 + / - 2 ) , minimal cooling group , ( 4.7 + / - 2 ) and mild cooling group ( 6.0 + / - 1 ) .
RESULTS	In the mild-cooled infants , the nasopharyngeal temperature was 34.5 degreesC during cooling , 1.2 degreesC lower than the rectal temperature .
RESULTS	This gradient narrowed to 0.5 degreesC after cooling was stopped .
RESULTS	No adverse effects because of cooling were observed .
RESULTS	No infants developed cardiac arrhythmias , hypotension , or bradycardia during cooling .
RESULTS	Thrombocytopenia occurred in 2 out of 10 controls , 2 out of 6 minimal cooling infants , and 1 out of 6 mild cooling infants .
RESULTS	Hypoglycemia ( glucose < 2.6 mM ) was seen on at least one occasion in 2 out of 10 controls , 4 out of 6 minimal cooling infants , and 1 out of 6 mild cooling infants .
RESULTS	Acute renal failure occurred in all infants .
RESULTS	The metabolic acidosis present in all infants at the time of enrollment into the study progressively resolved despite cooling , even in the mild hypothermia group .
CONCLUSIONS	Mild selective head cooling combined with mild systemic hypothermia in term newborn infants after perinatal asphyxia is a safe and convenient method of quickly reducing cerebral temperature with an increased gradient between the surface of the scalp and core temperature .
CONCLUSIONS	The safety of mild hypothermia with selective head cooling is in contrast with the historical evidence of adverse effects with greater depths of whole-body hypothermia .
CONCLUSIONS	This safety study and the strong experimental evidence for improved cerebral outcome justify a multicenter trial of selective head cooling for neonatal encephalopathy in term infants .

###10379186
OBJECTIVE	Amplified spontaneous pattern ( ASP ) ventilation is a new method for giving partial support by reproducing , in an amplified manner , the patients ' own spontaneous flow wave form , thereby optimizing patient adaptation to support .
OBJECTIVE	To study clinical use of ASP ventilation for the first time in terms of flow wave form , patient synchronization , ventilation pattern , work of breathing ( WOB ) , and inspiratory effort by transpulmonary pressure ( TPP ) and to compare ASP and pressure support ventilation applied in a similar clinical setting .
METHODS	We studied 20 patients after heart surgery during weaning from controlled ventilation .
METHODS	Each patient was ventilated during 4 phases of 15 min each with two similar levels of support using ASP and PS applied successively and randomly .
METHODS	Maximum support ( ASPmax and PSmax ) was that which was set to give the same respiratory frequency ( F ) and tidal volume ( VT ) as that recorded during the earlier period of controlled ventilation .
METHODS	Half support ( PEA1/2 and PS1/2 ) was set for half the aforementioned levels .
METHODS	At the end of each phase we obtained gas measurements and flow ( V ) curves and VT and pressure in airways and esophagus ( Pes ) to measure F , VT , the ratio of inspiratory to total time ( TI/TTOT and TPP , as well as the VT/Pes loop with a mechanical ventilation monitor .
METHODS	The WOB was determined by measuring area under the curve ( Campbell 's method ) .
RESULTS	We observed no significant differences between the two modes , with similar levels of support , with regard to ventilation ( PaCO2 ) or ventilatory pattern ( F , VT , TI/TTOT ) .
RESULTS	De-adaptation occurred , however , eight times with PS ( 25 % ) but never with ASP .
RESULTS	WOB and TPP decreased with PS when level of support increased , whereas with ASP these variables were constant regardless of level of amplification within the normal range .
CONCLUSIONS	Adaptation to support is better with ASP than with PS during postoperative weaning and causes no significant respiratory work overload .

###20501957
BACKGROUND	Erythropoietin ( EPO ) has been found to have anti-apoptotic and tissue protective effects on the myocardium .
BACKGROUND	The aim of the present pilot study was to observe the safety and efficacy of EPO administration for patients with acute myocardial infarction ( AMI ) .
RESULTS	Patients admitted with AMI had all undergone successful percutaneous coronary intervention ( PCI ) .
RESULTS	Patients were randomly assigned to 2 groups ( control and EPO groups ) , and given 12,000 IU EPO iv or saline after PCI .
RESULTS	The primary endpoints were the difference between the acute phase and chronic phase ( 6 months after the attack ) regarding left ventricular function as measured on electrocardiogram-gated single-photon emission computed tomography .
RESULTS	Thirty-six patients ( control 16 , EPO 20 ) were eligible for analysis .
RESULTS	Left ventricular ejection fraction ( LVEF ) significantly increased in the EPO group ( from 51.0 + / -19.6 % to 58.5 + / -15.0 % , P = 0.0238 ) , but not in the control group .
RESULTS	Further analysis was separately undertaken in patients with occlusion in the left anterior descending artery ( LAD ) and others ( non-LAD ) .
RESULTS	LVEF was < 50 % in most patients in the LAD subgroup , and LVEF significantly increased in the EPO group ( 37.5 + / -13.0 to 52.7 + / -15.8 , P = 0.0049 ) , but not in the control group .
RESULTS	EPO administration did not trigger any adverse clinical events .
CONCLUSIONS	EPO administration is a promising treatment for AMI .

###22748591
BACKGROUND	The integrase inhibitor elvitegravir ( EVG ) has been co-formulated with the CYP3A4 inhibitor cobicistat ( COBI ) , emtricitabine ( FTC ) , and tenofovir disoproxil fumarate ( TDF ) in a single tablet given once daily .
BACKGROUND	We compared the efficacy and safety of EVG/COBI/FTC / TDF with standard of care-co-formulated efavirenz ( EFV ) / FTC/TDF-as initial treatment for HIV infection .
METHODS	In this phase 3 trial , treatment-naive patients from outpatient clinics in North America were randomly assigned by computer-generated allocation sequence with a block size of four in a 1:1 ratio to receive EVG/COBI/FTC / TDF or EFV/FTC/TDF , once daily , plus matching placebo .
METHODS	Patients and study staff involved in giving study treatment , assessing outcomes , and collecting and analysing data were masked to treatment allocation .
METHODS	Eligibility criteria included screening HIV RNA concentration of 5000 copies per mL or more , and susceptibility to efavirenz , emtricitabine , and tenofovir .
METHODS	The primary endpoint was HIV RNA concentration of fewer than 50 copies per mL at week 48 .
METHODS	The study is registered with ClinicalTrials.gov , number NCT01095796 .
RESULTS	700 patients were randomly assigned and treated ( 348 with EVG/COBI/FTC / TDF , 352 with EFV/FTC/TDF ) .
RESULTS	EVG/COBI/FTC / TDF was non-inferior to EFV/FTC/TDF ; 305/348 ( 876 % ) versus 296/352 ( 841 % ) of patients had HIV RNA concentrations of fewer than 50 copies per mL at week 48 ( difference 36 % , 95 % CI -16 % to 88 % ) .
RESULTS	Proportions of patients discontinuing drugs for adverse events did not differ substantially ( 13/348 in the EVG/COBI/FTC / TDF group vs 18/352 in the EFV/FTC/TDF group ) .
RESULTS	Nausea was more common with EVG/COBI/FTC / TDF than with EFV/FTC/TDF ( 72/348 vs 48/352 ) and dizziness ( 23/348 vs 86/352 ) , abnormal dreams ( 53/348 vs 95/352 ) , insomnia ( 30/348 vs 49/352 ) , and rash ( 22/348 vs 43/352 ) were less common .
RESULTS	Serum creatinine concentration increased more by week 48 in the EVG/COBI/FTC / TDF group than in the EFV/FTC/TDF group ( median 13 mol/L , IQR 5 to 20 vs 1 mol/L , -6 to 8 ; p < 0001 ) .
CONCLUSIONS	If regulatory approval is given , EVG/COBI/FTC / TDF would be the only single-tablet , once-daily , integrase-inhibitor-based regimen for initial treatment of HIV infection .
BACKGROUND	Gilead Sciences .

###23904470
OBJECTIVE	To determine if early MRI measures predict X-ray progression at 1 and 2years in a large RA trial cohort .
METHODS	This study included 256 methotrexate ( MTX ) - nave RA patients from a randomised placebo-controlled trial of golimumab ( GO-BEFORE ) .
METHODS	MRIs of wrist and 2nd-5th metacarpophalangeal joints at 0 , 12 , 24 , 52 and 104weeks were obtained and scored using the RAMRIS system .
METHODS	Multivariable logistic regression examined if baseline and early change ( weeks 12/24 ) in RAMRIS scores independently predicted progression of the van der Heijde-Sharp ( vdHS ) score and MRI erosion score at 1 and 2years of follow-up .
RESULTS	High baseline score and poor improvement over the first 24weeks in synovitis ( p = 0.003 and p = 0.003 , respectively ) and in bone oedema ( p = 0.02 and p = 0.001 , respectively ) were independent predictors of X-ray progression at 1 year .
RESULTS	Associations were significant or tended towards an association at 2years .
RESULTS	An increase in RAMRIS bone erosion > 0.5 at weeks 12 and 24 also predicted X-ray progression ( p < 0.003 ) .
RESULTS	Poor 12-week improvement in bone oedema was associated with X-ray and MRI progression at 1year ( p < 0.05 ) .
RESULTS	Regression models that incorporated baseline and 12-week and 24-week changes in MRI measures of synovitis ( AUC = 0.71 ) and bone oedema ( AUC = 0.70 ) improved the prediction of X-ray progression at 1year above clinical disease activity alone ( AUC = 0.66 , p < 0.04 ) .
CONCLUSIONS	Baseline and early changes in MRI measures independently predicted X-ray and MRI progression at later time-points .
CONCLUSIONS	The predictive validity established here supports potential use in shorter-duration studies to determine efficacy of RA therapies in preventing structural damage .

###19898884
OBJECTIVE	The aim of the study was to assess the effect of breathing and physical exercise on pulmonary functions , apnea-hypopnea index ( AHI ) , and quality of life in patients with obstructive sleep apnea syndrome ( OSAS ) .
METHODS	Twenty patients with mild to moderate OSAS were included in the study either as exercise or control group .
METHODS	The control group did not receive any treatment , whereas the exercise group received exercise training .
METHODS	Exercise program consisting of breathing and aerobic exercises was applied for 1.5 h 3 days weekly for 12 weeks .
METHODS	Two groups were assessed through clinical and laboratory measurements after 12 weeks .
METHODS	In the evaluations , bicycle ergometer test was used for exercise capacity , pulmonary function test , maximal inspiratory-expiratory pressure for pulmonary functions , polysomnography for AHI , sleep parameters , Functional Outcomes of Sleep Questionnaire ( FOSQ ) , Short Form-36 ( SF-36 ) for quality of sleep and health-related quality of health , Epworth Sleepiness Scale for daytime sleepiness , and anthropometric measurements for anthropometric characteristics .
RESULTS	In the control group , the outcomes prior to and following 12-weeks follow-up period were found to be similar .
RESULTS	In the exercise group , no change was found in the anthropometric and respiratory measurements ( P > 0.05 ) , whereas significant improvements were found in exercise capacity , AHI , and FOSQ and SF-36 ( P < 0.05 ) .
RESULTS	After the follow-up period , it was shown that improvement in the experimental group did not lead to a statistically significant difference between the two groups ( P > 0.05 ) .
CONCLUSIONS	Exercise appears not to change anthropometric characteristics and respiratory functions while it improves AHI , health-related quality of life , quality of sleep , and exercise capacity in the patients with mild to moderate OSAS .

###11099326
OBJECTIVE	This trial sought to determine , for the first time , the validity in human vaccinations of using two different recombinant vaccines in diversified prime-and-boost regimens to enhance T-cell responses to a tumor antigen .
METHODS	Eighteen patients with advanced tumors expressing carcinoembryonic antigen ( CEA ) were randomized to receive either recombinant vaccinia ( rV ) - CEA followed by three avipox-CEA vaccinations , or avipox-CEA ( three times ) followed by one rV-CEA vaccination .
METHODS	Subsequent vaccinations in both cohorts were with avipox-CEA .
METHODS	Immunologic monitoring was performed using a CEA peptide and the enzyme-linked immunospot assay for interferon gamma production .
RESULTS	rV-CEA followed by avipox-CEA was superior to the reverse order in the generation of CEA-specific T-cell responses .
RESULTS	Further increases in CEA-specific T-cell precursors were seen when local granulocyte-macrophage colony-stimulating factor ( GM-CSF ) and low-dose interleukin ( IL ) -2 were given with subsequent vaccinations .
RESULTS	The treatment was extremely well tolerated .
RESULTS	Limited clinical activity was seen using vaccines alone in this patient population .
RESULTS	Antibody production against CEA was also observed in some of the treated patients .
CONCLUSIONS	rV-CEA was more effective in its role as a primer of the immune system ; avipox-CEA could be given up to eight times with continued increases in CEA T-cell precursors .
CONCLUSIONS	Future trials should use rV-CEA first followed by avipox-CEA .
CONCLUSIONS	Vaccines specific to CEA are able to generate CEA-specific T-cell responses in patients without significant toxicity .
CONCLUSIONS	T-cell responses using vaccines alone may be inadequate to generate significant anticancer objective responses in patients with advanced disease .
CONCLUSIONS	Cytokines such as GM-CSF and IL-2 may play a key role in generating such responses .

###23322466
OBJECTIVE	To assess radiographic progression , physical function , clinical disease activity , and safety in patients with rheumatoid arthritis ( RA ) who had inadequate response to methotrexate ( MTX ) and who were treated with tocilizumab-MTX or MTX during Year 2 of a 2-year study .
METHODS	During Year 1 , patients were randomized to placebo-MTX , 4 mg/kg tocilizumab-MTX , or 8 mg/kg tocilizumab-MTX .
METHODS	During Year 2 , patients continued the initial double-blind treatment or switched to open-label 8 mg/kg tocilizumab-MTX .
METHODS	Co-primary endpoints at Week 104 were mean change from baseline in Genant-modified Total Sharp Score ( GmTSS ) and adjusted mean area under the curve ( AUC ) for change from baseline in the Health Assessment Questionnaire-Disability Index ( HAQ-DI ) .
METHODS	Signs and symptoms of RA and safety were also evaluated .
RESULTS	At Week 104 , mean change from baseline in GmTSS was significantly lower for patients initially randomized to tocilizumab-MTX 4 mg/kg ( 0.58 ; p = 0.0025 ) or 8 mg/kg ( 0.37 ; p < 0.0001 ) than for patients initially randomized to placebo-MTX ( 1.96 ) .
RESULTS	Adjusted mean AUC of change from baseline in HAQ-DI was also significantly lower in patients initially randomized to tocilizumab-MTX 4 mg/kg ( -287.5 ; p < 0.0001 ) or 8 mg/kg ( -320.8 ; p < 0.0001 ) than in patients initially randomized to placebo-MTX ( -139.4 ) .
RESULTS	Signs and symptoms of RA were maintained or showed improvement .
RESULTS	No new safety signals were noted .
CONCLUSIONS	Compared with placebo-MTX , tocilizumab-MTX significantly inhibited structural joint damage and improved physical function in patients with RA who previously had inadequate response to MTX .
CONCLUSIONS	An extension of this study is continuing and will provide additional longterm efficacy and safety data .
CONCLUSIONS	National Clinical Trials registry NCT00106535 .

###22166903
BACKGROUND	In a previous randomised controlled phase 2 trial , intravenous infusion of salbutamol for up to 7 days in patients with acute respiratory distress syndrome ( ARDS ) reduced extravascular lung water and plateau airway pressure .
BACKGROUND	We assessed the effects of this intervention on mortality in patients with ARDS .
METHODS	We did a multicentre , placebo-controlled , parallel-group , randomised trial at 46 UK intensive-care units between December , 2006 , and March , 2010 .
METHODS	Intubated and mechanically ventilated patients ( aged 16 years ) within 72 h of ARDS onset were randomly assigned to receive either salbutamol ( 15 g/kg ideal bodyweight per h ) or placebo for up to 7 days .
METHODS	Randomisation was done by a central telephone or web-based randomisation service with minmisation by centre , pressure of arterial oxygen to fractional inspired oxygen concentration ( PaO ( 2 ) / F ( I ) O ( 2 ) ) ratio , and age .
METHODS	All participants , caregivers , and investigators were masked to group allocation .
METHODS	The primary outcome was death within 28 days of randomisation .
METHODS	Analysis was by intention-to-treat .
METHODS	This trial is registered , ISRCTN38366450 and EudraCT number 2006-002647-86 .
RESULTS	We randomly assigned 162 patients to the salbutamol group and 164 to the placebo group .
RESULTS	One patient in each group withdrew consent .
RESULTS	Recruitment was stopped after the second interim analysis because of safety concerns .
RESULTS	Salbutamol increased 28-day mortality ( 55 [ 34 % ] of 161 patients died in the salbutamol group vs 38 ( 23 % ) of 163 in the placebo group ; risk ratio [ RR ] 147 , 95 % CI 103-208 ) .
CONCLUSIONS	Treatment with intravenous salbutamol early in the course of ARDS was poorly tolerated .
CONCLUSIONS	Treatment is unlikely to be beneficial , and could worsen outcomes .
CONCLUSIONS	Routine use of -2 agonist treatment in ventilated patients with this disorder can not be recommended .
BACKGROUND	UK Medical Research Council , UK Department of Health , UK Intensive Care Foundation .

###25957003
OBJECTIVE	Bleeding esophageal varices has been studied extensively , but bleeding gastric varices ( BGV ) has received much less investigation .
OBJECTIVE	However , BGV has been reported in 30 % of patients with acute variceal bleeding .
OBJECTIVE	In our studies of 1,836 bleeding cirrhotics , 12.7 % were bleeding from gastric varices .
OBJECTIVE	BGV mortality rate of 45-55 % has been reported .
OBJECTIVE	The BGV literature has mainly involved retrospective case reports , often with short-term follow-up .
OBJECTIVE	We sought to describe the results of a prospective , randomized , controlled trial ( RCT ) in unselected , consecutive patients with BGV comparing endoscopic therapy ( ET ) with portacaval shunt ( PCS ; n = 518 ) , and later comparing emergency transjugular intrahepatic portosystemic shunt ( TIPS ) with emergency portacaval shunt ( EPCS ; n = 70 ) .
METHODS	Initially , our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding , mortality rate , and disability .
METHODS	When entry of patients ended , the RCT was expanded to compare emergency TIPS with EPCS ( n = 70 ) .
METHODS	This RCT of BGV was separate from our other RCTs of bleeding esophageal varices .
METHODS	Initially , ET was compared with PCS .
METHODS	In the second part of our RCT , emergency TIPS was compared with emergency PCS ( EPCS ) .
METHODS	Outcomes were survival , control of bleeding , portal-systemic encephalopathy ( PSE ) , quality of life , and direct costs of care .
METHODS	In the RCT of ET versus PCS , 28 and 30 % , respectively , were in Child class C.
METHODS	In the expanded RCT of TIPS versus EPCS , 40 and 41 % , respectively , were in Child class C. Permanent control of BGV was achieved in 97-100 % of patients treated by emergency or elective PCS , compared with 27-29 % by ET .
METHODS	TIPS was even less effective , achieving long-term control of BGV in only 6 % .
METHODS	Survival rates after PCS were greater at all time intervals and in all Child classes ( P < .001 ) .
METHODS	Repeated episodes of PSE occurred in 50 % of TIPS patients , 16-17 % treated by ET , and 8-11 % treated by PCS .
METHODS	Shunt stenosis or occlusion occurred in 67 % of TIPS patients , in contrast with 0-2 % of PCS patients .
CONCLUSIONS	These results support the conclusion that PCS is uniformly effective , whereas ET and TIPS are not very effective .

###21748252
BACKGROUND	( 4 ) ( 2 ) Neuronal nicotinic receptors ( NNRs ) are implicated in the pathophysiology of attention-deficit/hyperactivity disorder ( ADHD ) .
OBJECTIVE	This study examined the efficacy and safety of the ( 4 ) ( 2 ) NNR partial agonist ABT-089 versus placebo in adults with ADHD .
METHODS	In this multicenter , randomized , double-blind , placebo-controlled crossover study , subjects received placebo followed by ABT-089 ( 2 mg once daily [ QD ] , 5 mg QD , 15 mg QD , 40 mg QD , or 40 mg twice daily [ BID ] ) , or vice versa , in a 22 crossover design .
METHODS	Each treatment period was 4 weeks , separated by a 2-week washout period .
METHODS	The primary efficacy endpoint was the Conners ' Adult ADHD Rating Scale-Investigator Rated ( CAARS : Inv ) total score at the end of each treatment period .
METHODS	Secondary outcomes based on clinician - and self-rated efficacy scales were evaluated .
RESULTS	Of the 221 subjects enrolled , 171 met criteria for inclusion in the completers dataset for efficacy analyses .
RESULTS	ABT-089 was superior to placebo on the CAARS : Inv total score at 40 mg QD and 40 mg BID ( model-based least square mean difference from placebo : -4.33 , P = 0.02 ; -3.02 , P = 0.03 , respectively ) .
RESULTS	ABT-089 also demonstrated significant improvements on several secondary measures of efficacy .
RESULTS	ABT-089 was generally safe and well tolerated .
RESULTS	The most commonly reported adverse events ( 5 % ) for total ABT-089-treated subjects at rates higher than placebo were headache , upper respiratory tract infection , irritability , insomnia , and nasopharyngitis .
CONCLUSIONS	In this phase 2 crossover study , the NNR partial agonist ABT-089 , at doses of 40 mg QD and 40 mg BID , was efficacious and generally well tolerated in treatment of adults with ADHD .

###21761129
BACKGROUND	Calcineurin inhibitor ( CNI ) and steroid ( ST ) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens .
BACKGROUND	We conducted a single center , prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen .
METHODS	Forty-seven recipients of first renal transplant with non-HLA-identical living donors received sirolimus ( SRL ) , tacrolimus ( TAC ) , and ST without induction therapy and were randomized to undergo ST ( TAC/SRL group , n = 24 ) or TAC ( SRL/ST group , n = 21 ) withdrawal 3 months after transplantation .
METHODS	Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection ( BCAR ) and renal function at 12 months .
RESULTS	No differences were observed in the incidence of BCAR ( 4.2 % vs. 9.5 % ) , graft ( 95.8 % vs. 95.6 % ) , and patient ( 95.8 % vs. 95.6 % ) survivals or in renal function ( 60 11.5 vs. 63.4 10.5 ml/min , P = 0.361 ) .
RESULTS	Higher mean cholesterol concentration was observed in the SRL/ST group ( 191.9 63.3 vs. 241.6 61.5 mg/dl , P = 0.019 ) .
RESULTS	Treatment discontinuation due to adverse events occurred in 12.5 % of patients in TAC/SRL group and 21.7 % in SRL/ST group .
CONCLUSIONS	Within this short period of observation , our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies .

###11219143
OBJECTIVE	To compare colon cleansing and tolerance with two preparations : polyethylene glycol 4-liters ( PEG ) and sodium phosphate ( FS ) .
METHODS	Prospective randomized study of 100 consecutive patients who underwent endoscopy after taking PEG ( Bohm lavage solution ) or FS ( Fosfosoda ) .
METHODS	All patients were evaluated for the presence of adverse effects , degree of discomfort of the preparations ( 1 : mild , 2 : moderate , 3 : severe ) and the degree of cleansing with the products ( 1 : poor , 2 : fair , 3 : good , 4 : excellent ) .
RESULTS	Age , sex , depth of insertion and surgical history were similar for both groups .
RESULTS	Discomfort in the FS group was mild in 37 , moderate in 11 and severe in 2 ( mean score 1.30 + / - 0.54 ) ; in the PEG group it was mild in 28 , moderate in 15 and severe in 7 ( mean score 1.58 + / - 0.73 ) .
RESULTS	Colon cleansing was poor or fair in 11 ( 22 % ) patients in the PEG group and in 8 ( 16 % ) patients in the FS group and was good or excellent in 39 ( 78 % ) in the PEG group in comparison with 42 ( 84 % ) in the FS group .
RESULTS	Among the 50 patients who took the FS preparation , 12 had previously taken the PEG preparation and 11 of these preferred the FS preparation .
RESULTS	Among the 50 patients who took the PEG preparation , 10 had previously taken preparations : 4 had used enemas ( considering the present PEG to be worse ) and 6 had taken the same PEG as that used in the present study ( p < 0.005 ) .
RESULTS	One patient in the FS group and four in the PEG group did not complete the preparation because of vomiting .
RESULTS	The adverse effects of both preparations were similar .
CONCLUSIONS	The adverse effects and degree of colon cleansing were similar for FS and PEG .
CONCLUSIONS	Tolerance and patient comfort were greater with FS than with PEG .

###17124720
BACKGROUND	Treatment with DiaPep277 , a peptide derived from HSP60 , has been shown to preserve beta-cell function in non-obese diabetic mouse ( NOD ) mice and in a trial with newly diagnosed human patients with type 1 diabetes treated over a 10-month period .
BACKGROUND	This article extends the clinical trial observations to a total of 20 months of treatment to determine the safety and the effects of repeated doses of DiaPep277 on endogenous insulin secretion , metabolic control , and exogenous insulin requirements .
METHODS	Thirty-five male patients ( aged 16-58 ) with a basal C-peptide greater than 0.1 nmol/L were assigned to periodic treatment with DiaPep277 ( 1 mg ) or placebo for a 12-month treatment and 18-month observation protocol , later extended to an additional year of treatment .
METHODS	Stimulated C-peptide , HbA1c , and an exogenous insulin dose were the clinical endpoints .
RESULTS	At 18 months , stimulated C-peptide concentrations had fallen in the placebo group ( p = 0.0005 ) but were maintained in the DiaPep277 group .
RESULTS	The need for exogenous insulin was higher in the placebo group than in the DiaPep277 group .
RESULTS	Mean HbA1c concentrations were similar in both groups .
RESULTS	After extension of the study , patients continuing treatment with DiaPep277 and those switched from placebo to DiaPep277 manifested a trend towards a greater preservation of beta-cell function compared to patients maintained on or switched to placebo .
RESULTS	The safety profile of DiaPep277 was similar between the treatment and placebo groups , and no drug-related adverse events occurred .
CONCLUSIONS	Periodic treatment of subjects with DiaPep277 over 2 years was safe and associated preservation of endogenous insulin secretion up to 18 months was observed .

###10426833
OBJECTIVE	To describe the effects of exercise training on chronotropic incompetence in patients with stable heart failure , as measured by their inability to achieve a peak exercise heart rate greater than 85 % of maximum .
BACKGROUND	Exercise intolerance and chronotropic incompetence are characteristic of patients with heart failure .
BACKGROUND	Exercise training improves exercise capacity in these patients ; however , to what extent reversal of chronotropic incompetence contributes to such a response remains uncertain .
METHODS	Fifty-one patients undergoing standard medical therapy were randomly assigned to a 24-week exercise training program or a no exercise control group .
METHODS	Twenty-one of 26 patients assigned to the exercise group and 22 of 25 control patients completed the study .
METHODS	Peak oxygen consumption , resting and exercise plasma norepinephrine level , and quality of life ( Living With Heart Failure Questionnaire ) were assessed .
RESULTS	A significant ( P < .05 ) increase in peak heart rate was observed in the exercise group ( 9 + / - 3 beats/min ) when compared with the control group ( 1 + / - 3 beats/min ) .
RESULTS	Among exercise-trained patients with chronotropic incompetence at baseline ( n = 14 ) , the increase in peak heart rate at week 24 was 12 + / - 3 beats/min .
RESULTS	Peak oxygen consumption was significantly ( P < .05 ) increased in the exercise group ( 204 + / - 57 mL/min ) versus the control group ( 72 + / - 33 mL/min ) .
RESULTS	Health-related quality of life was not significantly changed with exercise training .
RESULTS	Twenty-four weeks of exercise training induced a greater ( P < .05 ) reduction in plasma norepinephrine at rest and during exercise in patients with a nonischemic cardiomyopathy versus those with ischemic cardiomyopathy .
CONCLUSIONS	Exercise training results in an increase in peak heart rate and partial reversal of chronotropic incompetence among patients with stable heart failure .
CONCLUSIONS	These responses contribute , in part , to the exercise training-induced increase in exercise capacity that occurs in these patients .

###21568746
OBJECTIVE	The study objectives were to evaluate the efficacy and safety of Tripterygium hypoglaucum Hutch ( THH ) in adult with severe chronic urticaria ( CU ) by performing a randomized , double-blind , placebo-controlled clinical trial .
METHODS	Seventy-eight ( 78 ) adult patients with severe CU , 21-58 years of age , responding poorly to antihistamines alone , were randomly divided into two groups : the therapeutic group with THH 3 tablets 3 times daily ( n = 40 ) and the control group with placebo 3 tablets 3 times daily ( n = 38 ) .
METHODS	Meanwhile , all patients jointly received cetirizine hydrochloride ( HCl ) 10mg once daily throughout the study period .
METHODS	The efficacy of THH was assessed by the scoring system of 4-point scale and the subject 's global assessment of relief .
RESULTS	Sixty-nine ( 69 ) of 78 patients ( 37 in the therapeutic group , 32 in the control group ) completed the study .
RESULTS	By the end of the fourth week , there was a 67 % improvement of total effective rate ( TER ) with THH compared with a 28 % improvement with placebo by per-protocol analysis ( ( 2 ) = 10.68 , p = 0.0011 ) , while by intention-to-treat analysis , 63 % and 24 % improvements of TER were respectively observed in the therapeutic group and the control group ( ( 2 ) = 11.36 , p = 0.001 ) .
RESULTS	THH with cetirizine showed statistical superiority to placebo with cetirizine during each study week for changes in total severity scores ( p0 .001 ) .
RESULTS	In weekly analyses , THH was also statistically superior to placebo in reducing the mean pruritus scores during each study week ( p0 .005 ) .
CONCLUSIONS	This study shows that the therapeutic effect of THH with cetirizine is predominant over that of cetirizine alone in adult CU .
CONCLUSIONS	THH with cetirizine may play an important role in the therapy of CU and be a useful treatment for CU .

###22188590
BACKGROUND	Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal .
BACKGROUND	The objectives of this study were to compare the efficacy and safety of once-daily ( OD ) evening and twice-daily ( BD ) regimens of the novel inhaled corticosteroid fluticasone furoate ( FF ) in asthma patients .
METHODS	Patients with moderate asthma ( age 12 years ; pre-bronchodilator forced expiratory volume in 1 second ( FEV1 ) 40-85 % predicted ; FEV1 reversibility of 12 % and 200 ml ) were randomized to FF or fluticasone propionate ( FP ) regimens in a double-blind , crossover study .
METHODS	Patients were not permitted to have used any ICS for 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 g OD , FF or FP 100 g BD and matching placebo by inhalation for 28 days each .
METHODS	Primary endpoint was Day 28 evening pre-dose ( trough ) FEV1 ; non-inferiority of FF 200 g OD and FF 100 g BD was assessed , as was superiority of all active treatment relative to placebo .
METHODS	Adverse events ( AEs ) and 24-hour urinary cortisol excretion were assessed .
RESULTS	The intent-to-treat population comprised 147 ( FF ) and 43 ( FP ) patients .
RESULTS	On Day 28 , pre-dose FEV1 showed FF 200 g OD to be non-inferior ( pre-defined limit -110 ml ) to FF 100 g BD ( mean treatment difference 11 ml ; 95 % CI : -35 to +56 ml ) ; all FF and FP regimens were significantly superior to placebo ( p 0.02 ) .
RESULTS	AEs were similar to placebo ; no serious AEs were reported .
RESULTS	Urinary cortisol excretion at Day 28 for FF was lower than placebo ( ratios : 200 g OD , 0.75 ; 100 g BD , 0.84 ; p 0.02 ) .
CONCLUSIONS	FF 200 g OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose .
BACKGROUND	Clinicaltrials.gov ; NCT00766090 .

###8489327
OBJECTIVE	To directly compare the efficacy of lithium carbonate and liothyronine sodium ( triiodothyronine ) in the augmentation of therapeutic response in antidepressant nonresponders .
METHODS	A randomized , double-blind , placebo-controlled study of 2 weeks ' duration .
METHODS	The Mood Disorders Program , Clarke Institute of Psychiatry and the University of Toronto , Ontario .
METHODS	Fifty outpatients , males and females , with unipolar , nonpsychotic major depression who had failed to respond to treatment with desipramine hydrochloride or imipramine hydrochloride .
RESULTS	Both liothyronine and lithium were more effective than placebo in reducing scores on the Hamilton Rating Scale for Depression .
RESULTS	However , the antidepressant augmenting effect of these two compounds did not differ from each other .
RESULTS	When response was defined as a 50 % or more reduction in the Hamilton Rating Scale for Depression scores and a final score less than 10 , we found that 10 of 17 subjects responded to liothyronine , nine of 17 responded to lithium and three of 16 responded to placebo .
CONCLUSIONS	Our study suggests that both lithium and liothyronine may be considered as alternatives in augmenting antidepressant response in patients who do not respond to treatment with a tricyclic antidepressant .

###16810592
OBJECTIVE	Propofol sedation is increasingly being used for endoscopy in the outpatient setting .
OBJECTIVE	In view of the agent 's short period of action , current recommendations that patients should avoid driving or using public transport unescorted for 24 h may be too strict .
OBJECTIVE	Psychomotor recovery and driving skills before and after sedation were therefore assessed .
METHODS	A total of 100 patients undergoing routine upper or lower gastrointestinal endoscopy were randomly sedated either with propofol alone or with midazolam plus pethidine .
METHODS	The recovery time and quality of recovery were assessed .
METHODS	Psychomotor recovery was evaluated using the number connection test ( NCT ) and a driving simulator test 1 h before and 2 h after the endoscopic procedure .
RESULTS	Ninety-six patients completed the 2-hour post-sedation procedure .
RESULTS	Vital signs were recorded , and no clinically relevant complications occurred .
RESULTS	The mean recovery time and quality of recovery were significantly better after propofol sedation ( 14 + / - 9 min vs. 25 + / - 8 min and 8.7 + / - 1.3 vs. 6.3 + / - 1.1 points ) ( P < 0.01 ) .
RESULTS	Psychomotor and driving skills after propofol sedation were similar to the baseline results , while in the midazolam/pethidine group , patients showed significantly more lane deviations ( 1.1 + / - 0.9 vs. 1.6 + / - 0.9 ) , time over the speed limit ( 0.3 + / - 0.83 vs. 0.6 + / - 0.88 ) , missed stoplights more often ( 0.05 + / - 0.31 vs. 0.11 + / - 0.35 ) , and had slower reaction times for unexpected events ( 1.11 + / - 0.46 s vs. 1.39 + / - 0.44 s ) ( P < 0.01 ) .
RESULTS	The time needed to complete the NCT after sedation did not differ between the two groups ( 32.1 + / - 12.0 s vs. 33.4 + / - 12.6 s for propofol ; 31.5 + / - 11.2 s vs. 34.6 + / - 12.8 s for midazolam/pethidine ) .
CONCLUSIONS	Current recommendations that patients should refrain from driving and unescorted use of public transport for 24 h after sedation may need to be reconsidered in patients who receive propofol sedation .

###20558004
BACKGROUND	Hydroxyethylstarches ( HES ) are thought to be beneficial in trauma and major surgery management , due to their volume expansion and anti-inflammatory properties .
BACKGROUND	This study examined the use of 6 % ( HES ) in burn resuscitation .
METHODS	26 adult patients with burns exceeding 15 % total body surface area ( TBSA ) were randomised to either crystalloid ( Hartmann 's solution ) or a colloid-supplemented resuscitation regime , where 1/3 of the crystalloid-predicted requirement was replaced by 6 % HES .
RESULTS	There was no difference in age , gender or TBSA between the two groups .
RESULTS	The median ( 95 % CI ) fluid volume / % TBSA received in the first 24 h was 307 ml and 263 ml for the crystalloid only and HES-supplemented group respectively ( p = 0.0234 , Mann-Whitney ) .
RESULTS	Body weight gain within the first 24 h after injury was significantly lower in the HES-supplemented group 2.5 kg versus 1.4 kg respectively ( p = 0.0039 ) .
RESULTS	The median ( 95 % CI ) serum C-reactive protein at 48 h after injury was 210 ( 167-257 ) and 128 ( 74-145 ) mg/L for the crystalloid only and HES-supplemented group respectively ( p = 0.0001 ) .
RESULTS	Albumin-creatinine ratio per % burn ( ACR , a marker of capillary leak ) was lower in the HES-supplemented group at 12h after burn ( p = 0.0310 ) .
CONCLUSIONS	Patients treated with HES-supplemented resuscitation required less fluid , showed less interstitial oedema and a dampened inflammatory response compared to patients receiving isotonic crystalloid alone .

###15577823
BACKGROUND	The exact mechanism of aspirin-induced asthma is not clear .
BACKGROUND	It has been postulated that precipitation of asthma attacks by aspirin is linked to inhibition of COX activity and massive release of cysteinyl leukotriene into the airway .
BACKGROUND	Tacrolimus , a macrolide-derived immunosuppressant , is used for immunosuppression in organ transplantation and also for allergic diseases such as atopic dermatitis .
OBJECTIVE	We evaluated the effects of tacrolimus in aspirin-induced asthma by using a double-blind , crossover study design .
METHODS	Twelve patients with aspirin-induced asthma ( male : female , 3:9 ; mean age + / - SD , 36.7 + / - 7.2 years ) received either tacrolimus ( 0.1 mg/kg ) or placebo 2 hours before the threshold dose of oral aspirin .
RESULTS	In the placebo arm , oral aspirin significantly decreased FEV 1 concomitant with significant increases in sputum eosinophilic cationic protein and urinary leukotriene E ( 4 ) levels .
RESULTS	Tacrolimus significantly inhibited bronchoconstriction and abrogated aspirin-induced increase in both sputum eosinophilic cationic protein and urinary leukotriene E ( 4 ) levels .
CONCLUSIONS	The current study suggested that tacrolimus inhibited bronchoconstriction to a threshold dose of aspirin by inhibition of cysteinyl leukotriene excretion .

###25284708
BACKGROUND	Adults with intellectual disability ( ID ) are physically very inactive .
BACKGROUND	This study will compare two approaches to increasing physical activity in adults with ID : a lifestyle physical activity ( light-moderate intensity ) approach and a structured exercise ( moderate-vigorous intensity ) approach .
BACKGROUND	The trial will compare the short-term ( 3-month ) and long-term ( 9-month ) outcomes and sustainability of each approach with a usual-care control group .
METHODS	A three-arm randomised controlled trial ( RCT ) will be conducted .
METHODS	Ninety adults with ID aged 18-55 will be randomly assigned to one of three groups : 1 ) a lifestyle physical activity group ( n = 30 ) , 2 ) a structured exercise group ( n = 30 ) , or 3 ) a usual care control group ( n = 30 ) .
METHODS	Participants in both groups will receive a 12-week intervention delivered by exercise specialists in the community with disability service staff , after which intervention will continue for 6months , delivered by disability service staff only .
METHODS	Primary outcomes are aerobic fitness , 12-hour energy expenditure , and proxy-reported everyday physical activity .
METHODS	Secondary outcomes include objectively assessed physical activity and sedentary behaviour , intervention compliance , functional walking capacity , participation in domestic activities , muscle strength , body composition , psychosocial outcomes , quality of life and health care costs .
CONCLUSIONS	The trial results will determine the effectiveness and sustainability of two approaches to increasing physical activity and exercise among adults with ID .
BACKGROUND	ISRCTN77889248 ( 18 April 2012 ) .

###22165032
BACKGROUND	In this study , ultra-rapid detoxification using dexmedetomidine under general anesthesia ( GA ) has been evaluated in preventing the withdrawal symptoms in patients addicted to opioids .
METHODS	Sixty male patients who were addicted to opioids were assigned to one of the two groups , in which anesthesia was induced and maintained using propofol infusion : group D = treated with dexmedetomidine during anesthesia and for 6 days after recovery from anesthesia ; group C = control group treated after recovery from anesthesia with oral dose of lefoxidine 0.2 mg three times daily .
METHODS	Hemodynamic changes and withdrawal symptoms were assessed using Objective Opiate Withdrawal Scale ( OOWS ) during anesthesia and both the Objective Opiate Withdrawal Scale ( OOWS ) and Subjective Opiate Withdrawal Scale ( SOWS ) after recovery from anesthesia .
METHODS	Patient satisfaction was assessed using 101-point verbal rating scale .
RESULTS	Hemodynamic data showed that there were statistically significant increases in heart rate and systolic blood pressure during anesthesia in control group .
RESULTS	Control group had significantly higher OOWS score on the following 3 days than the dexmedetomidine group , with no significant changes between the two groups from the fourth day till the sixth day except for muscle twitches in the control group on the sixth day ( Cd6 ) .
RESULTS	Control group had significantly higher SOWS score on the following 4 days than the dexmedetomidine group , with no significant changes between the two groups on the fifth and sixth days except for yawning , nausea , and muscle twitches in control group on the fifth and sixth days ( Cd5 , Cd6 ) .
RESULTS	Patient satisfaction was significantly greater in dexmedetomidine group than in control group .
CONCLUSIONS	Dexmedetomidine had shown to decrease markedly the withdrawal symptoms when used during ultra-rapid opiate detoxification under GA , and the patients in this group were more satisfied .

###19344946
OBJECTIVE	The aim of the present study was to clinically evaluate the suitability of Definite Multibond and Definite ormocer resin composite for luting of Cergogold glass ceramic inlays in a two-center trial involving two dentists .
METHODS	Thirty-nine patients received 98 Cergogold inlays with at least one inlay luted with Definite Multibond/Definite ( n = 45 ) and at least one inlay luted with Syntac/Variolink Ultra ( n = 53 ) in a split mouth design .
METHODS	Treatments were carried out in two private practices by two operators ( Operator A : n = 38 ; Operator B : n = 60 ) .
METHODS	Forty-four cavities required caries profunda treatment , 23 cavities exhibited no enamel at the cervical margin .
METHODS	At baseline ( 2 months ) , and after 6 , 14 , 27 , and 51 months of clinical service , the restorations were investigated according to modified USPHS criteria .
RESULTS	The drop-out rate was 3 % after 4 years .
RESULTS	After 48 months of clinical service , 21 restorations in 16 patients ( 9 luted with Definite , 12 with Variolink ; 2 placed by operator A and 19 by operator B ) had to be replaced due to inlay fracture ( n = 11 ) , tooth fracture ( n = 4 ) , hypersensitivities ( n = 3 ) , or marginal gap formation ( n = 3 ) .
RESULTS	Seventy-seven inlays were in good condition ( survival rate 89.9 % , median survival time 4.2 years ( 95 % confidence interval + / -0.25 ; survival analysis by Kaplan-Meier algorithm ) .
RESULTS	Survival rate after 4 years was 97.4 % for operator A , and 75.4 % for operator B ( p = 0.002 ; Log Rank/Mantel-Cox ) resulting in annual failure rates of 0.6 % and 6.2 % , respectively .
RESULTS	The operators did not differently judge the clinical behaviour of the luting procedures ( Mann-Whitney U-test , p > 0.05 ) .
RESULTS	Independent of the operator and the used luting system , the following criteria significantly changed over time : color match , marginal integrity , tooth integrity , inlay integrity , sensitivity , hypersensitivity , and X-ray control ( p < 0.05 ; Friedman test ) .
RESULTS	Significant differences between operators over the whole period were computed for the criteria marginal integrity , tooth integrity , and inlay integrity ( p < 0.05 , Mann-Whitney test ) .
RESULTS	Differences between luting materials were only present during single recalls .
CONCLUSIONS	For luting of ceramic inlays , only slight differences between the two luting systems were detectable .
CONCLUSIONS	The operator influence on clinical outcome was clearly proven .

###19628959
BACKGROUND	To date , there have been no studies comparing cognitive therapy ( CT ) with Rogerian supportive therapy ( RST ) in borderline personality disorder .
METHODS	Sixty-five DSM-IV borderline personality disorder outpatients were recruited at 2 centres : Lyon and Marseille .
METHODS	Thirty-three patients were randomly allocated to CT and 32 to RST .
METHODS	The therapists were the same in both groups .
METHODS	Both treatments shared the same duration ( 1 year ) and amount of therapy .
METHODS	Assessment by independent evaluators utilised the Clinical Global Impression ( CGI ) Scale , the Hamilton Depression Scale , Beck Depression Inventory , Beck Anxiety Inventory , Hopelessness Scale , Young Schema Questionnaire II , Eysenck Impulsivity Venturesomeness Empathy ( IVE ) Inventory , a self-harming behaviours checklist and scales measuring quality of life and the therapeutic relationship .
METHODS	The response criterion was a score of 3 or less on the CGI , associated with a Hopelessness Scale score of < 8 .
RESULTS	No patient committed suicide during the trial .
RESULTS	Fifty-one patients were evaluated at week 24 , 38 at week 52 and 21 at week 104 .
RESULTS	Cognitive therapy retained the patients in therapy for a longer time .
RESULTS	The response criterion found no significant between-group differences at any measurement point in the completers .
RESULTS	However , at week 24 , CT was better than RST on the Hopelessness Scale , IVE scale and regarding the therapeutic relationship .
RESULTS	At week 104 , the CGI improvement ( patient and evaluator ) was significantly better in CT than in RST .
RESULTS	High baseline depression and impulsivity predicted dropouts .
CONCLUSIONS	CT retained the patients in therapy longer , showed earlier positive effects on hopelessness and impulsivity , and demonstrated better long-term outcomes on global measures of improvement .

###23541174
BACKGROUND	The internationally recognized Advanced Trauma Operative Management ( ATOM ) course uses a 1:1 student-to-faculty teaching model .
BACKGROUND	This study examines a two student to one faculty ATOM teaching model .
METHODS	We randomly assigned 16 residents to four experienced ATOM faculty members .
METHODS	Half started with the one-student model and the other half with the two-student model and then switched using the same faculty .
METHODS	Students and faculty completed forms on the educational value of the two models ( 1 = very poor ; 2 = poor ; 3 = average ; 4 = good ; and 5 = excellent ) and identified educational preferences and recommendations .
RESULTS	We assigned educational values for the 13 procedures as follows : All faculty rated the one-student model as excellent ; six members rated the two-student model as excellent , and seven as good .
RESULTS	Students rated 50 % -75 % as excellent and 12 % -44 % as good for the two-student model , and 56 % -81 % as excellent and 12 % -44 % as good for the one-student model .
RESULTS	Given resource constraints , all faculty and 88 % of students preferred the two-student model .
RESULTS	With no resource constraints , 75 % of students and 50 % of faculty chose the two-student model .
RESULTS	All faculty and students rated both models `` acceptable . ''
RESULTS	Overall , 81 % of students and 50 % of faculty rated the two-student model better .
RESULTS	All faculty members recommended that the models be optional ; 94 % of students recommended that they be either optional ( 50 % ) or a two-student model ( 44 % ) .
RESULTS	Performing or assisting on each procedure twice was considered an advantage of the two-student model .
CONCLUSIONS	The two-student teaching model was acceptable and generally preferred in this study .
CONCLUSIONS	With appropriately trained faculty and students , the two-student model is feasible and should result in less animal usage and possibly wider promulgation .

###7953261
OBJECTIVE	To compare air insufflation with water irrigation during routine diagnostic flexible cystoscopy .
METHODS	A total of 200 consecutive patients scheduled for routine diagnostic flexible cystoscopy under topical anaesthesia were randomized prospectively to either air insufflation or water irrigation .
METHODS	Their tolerance to the procedure and post-operative symptoms were assessed from a questionnaire completed immediately after the procedure and then 1 week later .
RESULTS	Air insufflation offered a better cystoscopic view than water irrigation .
RESULTS	With regard to tolerance , in the air insufflation group , 72 % reported the procedure to be comfortable , 22 % uncomfortable and 6 % painful compared to 44 % , 45 % and 11 % respectively in the water irrigation group .
RESULTS	This difference in favour of air insufflation was highly significant ( Chi-square , P < 0.001 ) .
RESULTS	There was no statistical difference in either post-operative symptoms a week later or in the diagnostic yield between the two study groups .
RESULTS	There were no complications in either group .
CONCLUSIONS	Air insufflation cystoscopy is as safe and effective as water irrigation but better tolerated by patients .
CONCLUSIONS	This , together with its more obvious advantages of the ease of administration and low cost , should prompt more routine use of air insufflation cystoscopy for day case procedures .

###21128816
OBJECTIVE	It has been shown that patients with insulin resistance ( IR ) have a higher prevalence of thyroid nodules and bigger thyroid glands .
OBJECTIVE	We evaluated the ability of metformin ( M ) alone or combined with levothyroxine ( L-T ) to reduce the nodular size in benign thyroid hyperplastic nodules ( < 2cm in diameter ) .
METHODS	A total of 66 women with IR and nodular hyperplasia , diagnosed by fine needle aspiration biopsy ( FNAB ) , who completed this prospective 6-month duration protocol , were assigned to one of four groups : Group I ( GI ) ( n = 14 ) , patients treated with M ; GII ( n = 18 ) , patients treated with M plus L-T ; GIII ( n = 19 ) , patients treated with L-T ; and GIV ( n = 15 ) , patients without any treatment .
RESULTS	All groups of included patients had no statistically significant different mean baseline characteristics .
RESULTS	Patients from GII and GIII showed drops in thyroid-stimulating hormone ( TSH ) levels and GI and GII normalized the homeostasis model assessment ( HOMA ) index after treatment , as expected .
RESULTS	The median baseline size of all included nodules was 298mm 0.84 cm in diameter ( range , 32-3 ,616 mm ) .
RESULTS	After treatment , patients of Group I and II showed significant reductions in their nodule size [ median reduction , 108.50 mm ( 30 % ) and 184.5 mm ( 55 % ) , P < 0.008 and P < 0.0001 , respectively ] .
RESULTS	Patients in GIII and GIV did not have a significant reduction of their nodules [ P = not significant ( N.S. ) ] .
CONCLUSIONS	We conclude that M produced a significant decrease in the nodular size in patients with IR and small thyroid nodules , whereas the combination of M with L-T was the best treatment in these women .

###25281437
BACKGROUND	Hypotension is a common problem during spinal anesthesia for cesarean delivery .
BACKGROUND	Intravenous fluid loading is used to correct preoperative dehydration and reduce the incidence and severity of hypotension .
BACKGROUND	Different fluid regimens have been studied but colloid preload and crystalloid co-load have not been compared .
METHODS	In this randomized double-blind study , 210 patients scheduled for elective cesarean section under spinal anesthesia were randomly allocated to receive either 6 % hydroxyethyl starch 130/0 .4 500 mL before spinal anesthesia ( colloid preload ) or Ringer 's acetate solution 1000 mL administered rapidly starting with intrathecal injection ( crystalloid co-load ) .
METHODS	Maternal hypotension ( systolic blood pressure < 80 % of baseline or < 90 mmHg ) and severe hypotension ( systolic blood pressure < 80 mmHg ) were treated with 5 and 10mg ephedrine boluses , respectively .
METHODS	The primary outcome was the incidence of hypotension .
METHODS	Secondary outcomes included the incidence of severe hypotension , total ephedrine dose , nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis .
RESULTS	Data analysis was performed on 205 patients ; 103 in the colloid preload group and 102 in the crystalloid co-load group .
RESULTS	There were no significant differences in the incidence of hypotension ( 52.4 % vs. 42.2 % ; P = 0.18 ) or severe hypotension ( 15.5 % vs. 9.8 % ; P = 0.31 ) between colloid preload and crystalloid co-load groups , respectively .
RESULTS	The median [ range ] ephedrine dose was 5 [ 0-45 ] mg in the colloid preload group and 0 [ 0-35 ] mg in the crystalloid co-load group ( P = 0.065 ) .
RESULTS	There were no significant differences in maternal nausea or vomiting or neonatal outcomes between groups .
CONCLUSIONS	The use of 1000 mL crystalloid co-load has similar effect to 500 mL colloid preload in reducing the incidence of hypotension after spinal anesthesia for elective cesarean delivery .
CONCLUSIONS	Neither technique can totally prevent hypotension and should be combined with vasopressor use .

###18596714
OBJECTIVE	Whether postpartum visits by trained community health workers ( CHWs ) , reduce newborn breastfeeding problems .
METHODS	Community health workers made antenatal and postpartum home visits promoting newborn care practices including breastfeeding .
METHODS	CHWs assessed neonates for adequacy of breastfeeding and provided hands-on support to mothers to establish breastfeeding .
METHODS	History and observation data of 3495 neonates were analyzed to assess effects of CHW visitation on feeding problems .
RESULTS	Inappropriate breastfeeding position and attachment were the predominant problems ( 12 to 15 % ) .
RESULTS	Only 6 % of newborns who received home visit by CHWs within 3 days had feeding difficulties , compared to 34 % of those who did not ( odds ratio : 7.66 , 95 % confidence interval ( CI ) : 6.03 to 9.71 , P = 0.00 ) .
RESULTS	Latter group was 11.4 times ( 95 % CI : 6.7 to 19.3 , P = 0.00 ) more likely to have feeding problems as late as days 6 to 7 , than the former .
CONCLUSIONS	Counseling and hands-on support on breastfeeding techniques by trained workers within first 3 days of birth , should be part of community-based postpartum interventions .

###11275915
BACKGROUND	There is little information about how to adjust pharmacologic agents in the treatment of patients with advanced congestive heart failure ( CHF ) .
BACKGROUND	Some studies have suggested that use of pulmonary artery catheterization to guide reductions in filling pressures may improve outcomes for patients with heart failure who are hospitalized with evidence of elevated filling pressures .
BACKGROUND	However , there is no consensus regarding the true utility of this strategy .
BACKGROUND	A randomized clinical trial is needed to test the safety , efficacy , and treatment benefit of pulmonary artery catheterization in patients with advanced CHF .
METHODS	The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ( ESCAPE ) trial is a multicenter , randomized trial designed to test the long-term safety and efficacy of treatment guided by hemodynamic monitoring and clinical assessment versus that guided by clinical assessment alone in patients hospitalized with New York Heart Association class IV CHF .
METHODS	Five hundred patients will be randomly assigned to receive either medical therapy guided by a combination of clinical assessment and hemodynamic monitoring ( PAC arm ) or medical therapy guided by clinical assessment alone ( CLIN arm ) .
METHODS	The primary end point of ESCAPE will be the number of days that patients are hospitalized or die during the 6-month period after randomization .
METHODS	Secondary end points will include changes in mitral regurgitation , peak oxygen consumption , and natriuretic peptide levels .
METHODS	Other secondary end points will be pulmonary artery catheter-associated complications , resource utilization , quality of life measures , and patient preferences regarding survival .
CONCLUSIONS	The primary goal of ESCAPE will be to provide information about the utility of the pulmonary artery catheter in patients with advanced heart failure , independent of various treatment approaches used by individual physicians .
CONCLUSIONS	In addition , this study will define current outcomes for this severely compromised population .

###19501210
BACKGROUND	A formulation of depot medroxyprogesterone acetate ( DMPA ) has been developed that allows subcutaneous injection ( 104 mg/0 .65 mL ; DMPA-SC ) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA ( 150 mg/mL ; DMPA-IM ) .
METHODS	This randomized , evaluator-blinded study was designed to compare efficacy , safety , and user satisfaction in women receiving DMPA-SC ( n = 266 ) or DMPA-IM ( n = 268 ) for 2 years with an option to continue for a third year .
METHODS	The primary objectives were to evaluate bone mineral density ( BMD ) changes and contraceptive efficacy after 2 years .
RESULTS	A total of 225 women completed the first 2 years of this study ( DMPA-SC , n = 116 ; DMPA-IM , n = 109 ) .
RESULTS	After 2 years of DMPA use , BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip ( -3.3 % and -3.6 % , respectively ) and lumbar spine ( -4.3 % and -5.0 % , respectively ) .
RESULTS	In those women who received DMPA during the third year , there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3 .
RESULTS	Recovery of BMD was observed in the small subpopulation of women who had discontinued DMPA-SC or DMPA-IM after the second year .
RESULTS	The 2-year treatment-failure cumulative pregnancy rate was 0 % in the DMPA-SC group and 0.8 % ( 95 % confidence interval , 0.00-2 .37 % ) in the DMPA-IM group ( life-table method ) .
RESULTS	Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group .
CONCLUSIONS	DMPA-SC is an effective and well-tolerated contraceptive option , providing comparable efficacy and BMD safety to DMPA-IM .

###25351456
OBJECTIVE	Cancer anorexia-cachexia syndrome ( CACS ) is common in advanced cancer patients and associated with weight loss , fatigue , impaired quality of life ( QoL ) , and poor prognosis .
OBJECTIVE	The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 ( NCT01387282 ) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer ( NSCLC ) cachexia : the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) and the Functional Assessment of Anorexia/Cachexia Therapy ( FAACT ) .
METHODS	In the ROMANA 2 trial , 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized ( 2:1 ) to receive anamorelin HCl or placebo once daily for 12weeks .
METHODS	All 203 patients who reached the week 12 visit at the time of data analysis were included .
METHODS	Co-primary endpoints were change from baseline in lean body mass and handgrip strength .
METHODS	QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3 , 6 , 9 , and 12 .
RESULTS	Two 4-item scales ( fatigue/activity and appetite/eating ) from the FACIT-F and FAACT questionnaires , respectively , demonstrated good internal consistency reliability , validity , and responsiveness ( also referred to as the Simplified Evaluation of Fatigue ( SEF ) and Simplified Evaluation of Appetite ( SEA ) , respectively ) .
RESULTS	The estimated important difference for each scale was 1-2 points .
CONCLUSIONS	These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS .
CONCLUSIONS	Additional work should examine the clinical utility of these scales and their impact on treatment decision-making .

###15489085
OBJECTIVE	This trial evaluated the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis .
BACKGROUND	Warfarin was more effective than aspirin in preventing stroke in these patients ; combined therapy with low anticoagulant intensity was ineffective .
BACKGROUND	Mitral stenosis patients were not investigated .
METHODS	We performed a multicenter randomized trial in 1,209 patients at risk .
METHODS	The intermediate-risk group included patients with risk factors or age > 60 years : 242 received the cyclooxygenase inhibitor triflusal , 237 received acenocumarol , and 235 received a combination of both .
METHODS	The high-risk group included patients with prior embolism or mitral stenosis : 259 received anticoagulants and 236 received the combined therapy .
METHODS	Median follow-up was 2.76 years .
METHODS	Primary outcome was a composite of vascular death and nonfatal stroke or systemic embolism .
RESULTS	Primary outcome was lower in the combined therapy than in the anticoagulant arm in both the intermediate - ( hazard ratio [ HR ] 0.33 [ 95 % confidence interval ( CI ) 0.12 to 0.91 ] ; p = 0.02 ) and the high-risk group ( HR 0.51 [ 95 % CI 0.27 to 0.96 ] ; p = 0.03 ) .
RESULTS	Primary outcome plus severe bleeding was lower with combined therapy in the intermediate-risk group .
RESULTS	Nonvalvular and mitral stenosis patients had similar embolic event rates during anticoagulant therapy .
CONCLUSIONS	The combined antiplatelet plus moderate-intensity anticoagulation therapy significantly decreased the vascular events compared with anticoagulation alone and proved to be safe in atrial fibrillation patients .

###20433700
BACKGROUND	The aim was to identify predictors of change in objectively measured physical activity over 12 months in the ProActive cohort to improve understanding of factors influencing change in physical activity .
METHODS	ProActive is a physical activity promotion trial that took place in Eastern England ( 1999-2004 ) .
METHODS	365 offspring of people with type 2 diabetes underwent measurement of physical activity energy expenditure ( PAEE ) using heart rate monitoring , fitness , and anthropometric and biochemical status at baseline and 1 year ( n = 321 ) .
METHODS	Linear regression was used to quantify the associations between baseline demographic , clinical , psychosocial and behavioural variables and change in PAEE over 12 months .
METHODS	This study is registered as ISRCTN61323766 .
RESULTS	ProActive participants significantly increased their PAEE by 0.6 kj/min ( SD 4.2 , p = 0.006 ) over one year , the equivalent of around 20 minutes brisk walking/day .
RESULTS	Male sex and higher fitness at baseline predicted increase in PAEE .
RESULTS	No significant associations were found for any other variables .
RESULTS	Very few baseline demographic , clinical , psychosocial and behavioural predictors were associated with change in objectively measured physical activity .
CONCLUSIONS	Traditional baseline determinants of self-reported physical activity targeted by behavioural interventions may be relatively weak predictors of change in objectively measured physical activity .
CONCLUSIONS	Further research is needed to improve our understanding of factors influencing change in physical activity to inform the development and targeting of interventions .

###9698966
BACKGROUND	Currently , there are no data available concerning the occupational exposure to desflurane during general anaesthesia .
BACKGROUND	This prospective , randomized study reports on occupational exposure to desflurane , compared to isoflurane , in a modern operation theatre ( OT ) .
METHODS	The study was performed in an OT equipped with a modern air-conditioning system and with a low-leakage anaesthesia machine connected to a central scavenging system .
METHODS	Trace concentrations of the anaesthetics were measured continuously by means of a photoacoustic infrared spectrometer during general anaesthesia in 30 patients undergoing eye surgery .
METHODS	Values were obtained within the breathing zone of the anaesthetist , the surgeon , the auxiliary nurse and at the mouth of the patient .
RESULTS	Desflurane and isoflurane were administered with median ( range ) endtidal concentrations of 4.7 ( 3.8-10 .3 ) vol % and 0.9 ( 0.6-1 .4 ) vol % , respectively .
RESULTS	The personnel-related median values of the average trace concentrations of desflurane and isoflurane were 0.5 ( 0.01-7 .5 ) ppm and 0.2 ( 0.01-1 .6 ) ppm , respectively .
CONCLUSIONS	Occupational exposure to desflurane is low in the environment of a modern OT , even though it has to be administered in approximately 5-fold higher concentrations compared to isoflurane .

###10468696
BACKGROUND	No currently available treatment provides consistent relief of irritable bowel syndrome .
BACKGROUND	Colonic sensory and motor function are modulated partly through 5HT3-receptors .
OBJECTIVE	To evaluate effects of the 5HT3-receptor antagonist , alosetron , in irritable bowel syndrome .
METHODS	Randomized , double-blind , placebo-controlled , dose-ranging ( 1 , 2 , 4 , 8 mg b.d. alosetron ) , 12-week trial in 370 patients with diarrhoea-predominant or alternating constipation and diarrhoea irritable bowel syndrome .
METHODS	Weekly measurement of adequate relief was the key end-point ; other irritable bowel syndrome symptoms were collected daily using an electronic phone system .
RESULTS	Alosetron ( 1 mg or 2 mg b.d. ) significantly ( P < 0.05 vs. placebo ) increased the proportion of females , but not males , reporting adequate relief .
RESULTS	Stool consistency , frequency and percentage days with urgency improved over placebo ( P < 0.05 ) within the first month with all doses of alosetron , and persisted throughout the trial with all doses in female patients .
RESULTS	With 1 mg b.d. alosetron , females had improved stool consistency and urgency within the first week , and adequate relief and improved stool frequency within the first 2 weeks .
RESULTS	There was no consistent improvement in bowel function among male patients .
CONCLUSIONS	In female irritable bowel syndrome patients with predominant diarrhoea or alternating constipation and diarrhoea , alosetron is effective in treatment of abdominal pain and discomfort and bowel-related symptoms .

###23469601
OBJECTIVE	To observe the clinical effects of Qiyao Xiaoke Capsule ( QXC ) on patients with type 2 pre-diabetes .
METHODS	Totally 116 pre-diabetes patients were randomly assigned to the Chinese medicine group ( CM , 76 cases ) and the blank control group ( BC , 40 cases ) in the ratio of 2 : 1 .
METHODS	All patients received proper diet control , health education , and exercises , and so on .
METHODS	Besides , patients in the CM group took QXC ( 0.4 g/pill ) , 6 pills each time , three times a day .
METHODS	But patients in the BC group were intervened by life style alone .
METHODS	The fasting blood glucose ( FBG ) , postprandial blood glucose ( PBG ) , insulin ( FINS , 2h INS ) , glycosylated hemoglobin ( HbAlc ) , blood lipids ( TG , TC , HDL-C , and LDL-C ) , and efficacy of CM symptoms were observed in the two groups before and after intervention .
METHODS	The sequelae were observed at the end of the treatment and at follow-ups .
RESULTS	After treatment FBG , PBG , and HbA1c decreased in all patients of the two groups ( P < 0.05 , P < 0.01 ) , with 2 h PBG decreased more significantly .
RESULTS	But there was no statistical difference between the two groups ( P > 0.05 ) .
RESULTS	The two methods could improve the secretion of FINS .
RESULTS	Especially 2 h INS decreased more significantly in the CM group , showing statistical difference when compared with the BC group ( P < 0.05 ) .
RESULTS	The two methods could improve the metabolism of blood lipids .
RESULTS	CM could significantly lower TG and elevate HDL-C , showing statistical difference when compared with before treatment ( P < 0.05 ) .
RESULTS	After treatment the CM symptoms were obviously improved , showing statistical difference when compared with the BC group ( P < 0.05 ) .
RESULTS	The normalization rate was better in the CM group than in the BC group at the end of the treatment and at follow-ups ( P < 0.05 ) .
CONCLUSIONS	QXC combined life style intervention could improve fasting and postprandial insulin secretion of type 2 pre-diabetes patients , regulate glycolipid metabolism , correct the insulin resistance state , and improve the symptoms of qi-yin insufficiency .
CONCLUSIONS	It could postpone or hinder the occurrence and development of type 2 diabetes .
CONCLUSIONS	It was more effective and durable than changing the life style alone .

###24119718
BACKGROUND	The aim of this study was to evaluate the effect of perioperative alfacalcidol on postoperative hypocalcemia after total thyroidectomy .
METHODS	A total of 219 patients scheduled for total thyroidectomy were randomized into groups not receiving ( group A ) or receiving ( group B ) perioperative alfacalcidol .
METHODS	Postoperative hypocalcemia was compared between groups on postoperative day ( POD ) 1 and POD2 .
METHODS	Patients with hypocalcemia ( < 2.00 mmol/L ) received oral calcium supplementation .
METHODS	Calcium and vitamin D levels were measured at 5-week and 6-month follow-ups .
RESULTS	The incidence of symptomatic hypocalcemia was significantly lower in group A ( P = .02 ) , whereas similarly low levels of calcemia were observed in both groups on POD1 ( 37 % and 30 % , respectively ; P = not significant ) and persisted on POD2 ( 14 % and 6 % , respectively ; P = not significant ) .
RESULTS	Patients with severe hypocalcemia ( < 1.90 mmol/L ) showed faster recovery in group A compared with group B ( 6 % vs 1 % , P = .04 ) .
RESULTS	At 5 weeks , calcium and vitamin D levels were similar between the groups .
RESULTS	Six months after surgery , 4 % ( group A ) versus 0 % ( group B ) of subjects exhibited permanent hypoparathyroidism ( P = .04 ) .
CONCLUSIONS	Although the treatment did not correct vitamin D deficiency , perioperative alfacalcidol uptake resulted in decreased transient hypocalcemia and related symptoms in patients undergoing total thyroidectomy .

###21358373
BACKGROUND	Emerging data suggest limited patient preparation for ambulatory surgery , decreased access to healthcare providers postoperatively , increased patient and family anxiety , and increased patient suffering .
BACKGROUND	Thus , there is a need for nursing interventions to improve the postoperative experience for patients and families .
OBJECTIVE	The purpose of this study was to test the hypothesis that ambulatory arthroscopic surgery patients who receive a nurse-coached telephone intervention will have significantly less symptom distress and better functional health status than a comparable group who receive usual practice .
METHODS	The study sample in this randomized clinical trial with repeated measures was 102 participants ( 52 in the intervention group and 50 in the usual practice group ) drawn from a large academic medical center in the Northeast United States .
METHODS	Symptom distress was measured using the Symptom Distress Scale , and functional health was measured using the Medical Outcomes Study 36-Item Short-Form Health Survey General Health Perceptions and Mental Health subscales .
RESULTS	Multivariate analysis of covariance , with three repeated measures of the Symptom Distress Scale ( baseline , 72 hours postsurgery , and 1 week postsurgery ) and five covariates , was used to test the hypothesis .
RESULTS	After removal of the covariate influence , intervention participants had significantly less symptom distress at 72 hours and 1 week postsurgery and significantly better overall physical and mental health at 1 week postsurgery than those who received usual practice .
CONCLUSIONS	The findings suggest that telephone calls from nurses during the immediate postoperative period resulted in improved patient outcomes , namely , less symptom distress and better physical and mental health states .
CONCLUSIONS	In future research , the study sample should be expanded to older and more diverse patients .

###15205566
OBJECTIVE	To find out the effect of estradiol with progesterone for luteal phase support in IVF-ICSI cycles .
METHODS	Patients were accepted for treatment in the ART unit of Selcuk University , Meram Faculty of Medicine , between January 2001 and March 2003 .
METHODS	The study was done in a prospective manner .
METHODS	The age range of 252 women was 19-41 years and the total number of cycles was 310 .
METHODS	All patients were treated with a long ovulation induction protocol .
METHODS	Patients were treated and divided into two groups in a randomized manner : group I used only 600 mg/day divided into three equal doses of micronized progesterone vaginally , and group II used transdermal estradiol 100 microg/day + 600 mg/day vaginal micronized progesterone .
RESULTS	310 ICSI cycles were carried out in 252 infertile couples between January 2001 and March 2003 .
RESULTS	From 22 of these cycles , oocytes were retrieved but no embryos were developed .
RESULTS	In the remaining 288 cycles there were embryo transfers .
RESULTS	All embryo development was achieved by ICSI treatment .
RESULTS	In 148 out of 288 cycles , the luteal phase was supported only by vaginal micronized progesterone ( group I ) .
RESULTS	On the other hand , the remaining 140 cycles received vaginal micronized progesterone plus transdermal estradiol 100 microg/day ( group II ) .
RESULTS	The number of beta-hCG-positive results in group I and group II were 20 ( 13.5 % ) and 54 ( 38.5 % ) respectively .
CONCLUSIONS	Adding estradiol to progesterone for luteal phase support in ICSI-ET cycles may increase implantation and pregnancy rates .

###12744767
BACKGROUND	Nosocomial infection is a major cause of surgical morbidity and mortality .
BACKGROUND	Methicillin-resistant Staphylococcus aureus ( MRSA ) has become a prominent organism in colonization and infection in surgical patients .
BACKGROUND	Pressure sores are a major reservoir of MRSA .
METHODS	In this study , 33 patients with full-thickness pressure sores were randomized to receive standard care or radiant heat therapy using a Warm Up device ( Augustine Medical , Eden Prairie , MN ) .
METHODS	Weekly microbial sampling was used for assessment of bacterial presence .
METHODS	None of the patients received antibiotics prior to or during the eight weeks of study .
RESULTS	More than 50 species of bacteria were present in the pressure sores with a median of four organisms per sample .
RESULTS	Methicillin-resistant S. aureus was found in 14 of the patients ' pressure sores .
RESULTS	In the warming group ( n = 8 ) , MRSA was eradicated in six patients within 2 weeks of warming , whereas in the control group none had eradication ( Fisher 's exact test , p = 0.01 ) .
RESULTS	Eradication was defined as three consecutive weekly swabs without bacterial growth .
CONCLUSIONS	The warming of pressure sores is being assessed as an adjunct to healing , but there is some promise that colonization by MRSA may be eradicated , thereby reducing a potential reservoir of organisms .
CONCLUSIONS	The risk to surgical patients when patients are harboring MRSA may be minimized by warming therapy .

###10386508
BACKGROUND	Treatment with warfarin sodium is effective for stroke prevention in atrial fibrillation but many physicians hesitate to prescribe it to elderly patients presumably because of the associated risk for bleeding and the inconvenience of frequent blood tests for the patients .
METHODS	In the Second Copenhagen Atrial Fibrillation , Aspirin , and Anticoagulation ( AFASAK 2 ) Study , we studied the rate of bleeding events associated with the incidence of thromboembolic events in patients receiving warfarin sodium , 1.25 mg/d ; warfarin sodium , 1.25 mg/d , plus aspirin , 300 mg/d ; aspirin , 300 mg/d ; or adjusted-dose warfarin therapy aiming at an international normalized ratio of the prothrombin time ratio ( INR ) of 2.0 to 3.0 .
METHODS	The study was scheduled for 6 years from May 1 , 1993 , but owing to evidence of inefficiency of low-intensity therapy plus aspirin from another study it was prematurely terminated on October 2 , 1996 .
METHODS	Minor and major bleeding events were recorded prospectively .
METHODS	The rate of bleeding was calculated using the Kaplan-Meier method and risk factors were identified by the Cox proportional hazards model .
RESULTS	Of 677 included patients , 130 ( median age , 77 years ; range , 67-89 years ) experienced bleeding .
RESULTS	One woman and 12 men experienced major bleeding .
RESULTS	Four had intracranial bleeding : 2 cases were fatal and 2 were nonfatal .
RESULTS	During treatment with mini-dose warfarin , warfarin plus aspirin , aspirin , and adjusted-dose warfarin , the annual rate of major bleeding was 0.8 % , 0.3 % , 1.4 % , and 1.1 % , respectively ( P = .20 ) .
RESULTS	After 3 years of treatment the cumulative rate of any bleeding was 24.7 % , 24.4 % , 30.0 % , and 41.1 % ( P = .003 ) , respectively .
RESULTS	Increasing INRvalue ( P < .001 ) and prior myocardial infarction ( P = .001 ) were independent risk factors for bleeding , whereas increasing age was not .
CONCLUSIONS	Fixed mini-dose warfarin and aspirin alone or in combination were associated with both minor and major bleeding .
CONCLUSIONS	The small number of major bleeding events in patients receiving adjusted-dose warfarin therapy as compared with those receiving less intensive antithrombotic treatments and the finding of no significant influence of age on the risk for bleeding indicate that even elderly patients with atrial fibrillation tolerate adjusted-dose warfarin therapy ( INR , 2.0-3 .0 ) .

###19930021
OBJECTIVE	This study examined factors associated with treatment drop-out among young people aged 13-19 years attending alcohol and other drug ( AOD ) treatment .
METHODS	Data were gathered from structured interviews ( n = 79 ) and a clinical file search of 184 randomly selected young people who had attended youth specific AOD treatment services in Aotearoa , New Zealand during 2003 or 2004 .
RESULTS	The median length of stay was 2.7 months for those attending day/residential services ( n = 42 ) and 4.0 sessions for those attending outpatient services ( n = 37 ) 16.7 % of participants from day/residential services dropped out of treatment early ( within the first month ) and 32.4 % of participants from outpatient treatment services dropped out of treatment early ( before the third session ) .
RESULTS	Fixed client characteristics , such as age , sex , ethnicity , substance use and mental health diagnoses were not found to be associated with treatment retention .
RESULTS	Dynamic client characteristics , such as motivation to attend treatment and expectations about treatment outcomes and program characteristics , such as positive experiences with treatment staff and feeling involved in the treatment process were found to be associated with treatment retention .
CONCLUSIONS	The findings of this study support previous research indicating that fixed client characteristics are not sufficient to explain youth retention in AOD treatment .
CONCLUSIONS	Of more use are dynamic client characteristics and program variables .
CONCLUSIONS	These findings stress the potential for improving treatment retention by creating more youth appropriate services .

###19804842
OBJECTIVE	Sequential therapy with a proton pump inhibitor ( PPI ) and amoxicillin followed by a PPI , clarithromycin , and an imidazole agent reportedly have a better rate of curing Helicobacter pylori infection than PPI , amoxicillin , and clarithromycin triple therapy .
OBJECTIVE	The concomitant administration of these 4 drugs ( concomitant therapy ) is also an effective treatment strategy .
OBJECTIVE	We compared the efficacies of sequential and concomitant therapy and analyzed the effects of antibiotic resistance in patients with H pylori infection .
METHODS	In a randomized trial of 232 H pylori-infected patients from 3 hospitals in Kaohsiung , Taiwan , patients were given 10 days of sequential ( n = 115 ) or concomitant ( n = 117 ) therapy .
METHODS	H pylori status was confirmed by endoscopy or urea breath test .
RESULTS	Intention-to-treat analysis demonstrated similar eradication rates for sequential ( 92.3 % ; 95 % confidence interval [ CI ] , 87.5 % -97.1 % ) and concomitant therapy ( 93.0 % ; 95 % CI , 88.3 % -97.7 % ) ( P = .83 ) .
RESULTS	Per-protocol eradication results were similar for sequential ( 93.1 % ; 95 % CI , 90.7 % -95.5 % ) and concomitant therapy ( 93.0 % ; 95 % CI , 88.3 % -97.7 % ) ( P = .99 ) .
RESULTS	Univariate analysis showed that compliance and resistance to clarithromycin were independent determinants of eradication .
RESULTS	Dual resistance did not influence the level of eradication in the concomitant group , but significantly affected that of the sequential therapy group .
RESULTS	Clarithromycin resistance was less frequent than expected .
CONCLUSIONS	Sequential or concomitant therapy with a PPI , amoxicillin , clarithromycin , and an imidazole agent are equally effective and safe for eradication of H pylori infection .
CONCLUSIONS	Resistance to clarithromycin , compliance , and adverse events reduced the level of eradication .
CONCLUSIONS	Concomitant therapy may be more suitable for patients with dual resistance to antibiotics .

###18676350
BACKGROUND	The different efficacy of subcutaneous and intravenous rHuEPO results in higher doses and costs in intravenously treated patients .
BACKGROUND	Darbepoetin alfa has a different pharmacokinetic profile compared to rHuEPO , and previous clinical experience suggests that subcutaneous and intravenous darbepoetin alfa may have similar efficacy .
BACKGROUND	Objective .
BACKGROUND	The aim of this study was to compare the efficacy of intravenous and subcutaneous darbepoetin alfa regarding haemoglobin levels and doses .
METHODS	Patients treated with subcutaneous darbepoetin alfa for at least 6 months were randomized 1:1 to continue with subcutaneous treatment of darbepoetin alfa or to switch to the intravenous administration route .
METHODS	The application frequency was not altered .
METHODS	Darbepoetin alfa dose as well as haemoglobin concentrations were evaluated as per patient average at baseline ( Week -3 + / - 1 ) , Week 24 + / - 3 and Week 48 + / - 3 .
RESULTS	One hundred fourteen patients in 9 German dialysis centres were included .
RESULTS	Fifty-three patients were treated intravenously and 61 patients continued the subcutaneous therapy .
RESULTS	Mean haemoglobin levels and mean weekly darbepoetin alfa dose did not change significantly in either treatment group .
CONCLUSIONS	Our data suggest that the darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment .

###22011360
BACKGROUND	Interactive video games such as the Nintendo Wii Fit are increasingly used as a therapeutic tool in health and aged care settings however , their acceptability to older people is unclear .
BACKGROUND	The aim of this study was to determine the acceptability of the Nintendo Wii Fit as a therapy tool for hospitalised older people using a discrete choice experiment ( DCE ) before and after exposure to the intervention .
METHODS	A DCE was administered to 21 participants in an interview style format prior to , and following several sessions of using the Wii Fit in physiotherapy .
METHODS	The physiotherapist prescribed the Wii Fit activities , supervised and supported the patient during the therapy sessions .
METHODS	Attributes included in the DCE were : mode of therapy ( traditional or using the Wii Fit ) , amount of therapy , cost of therapy program and percentage of recovery made .
METHODS	Data was analysed using conditional ( fixed-effects ) logistic regression .
RESULTS	Prior to commencing the therapy program participants were most concerned about therapy time ( avoiding programs that were too intensive ) , and the amount of recovery they would make .
RESULTS	Following the therapy program , participants were more concerned with the mode of therapy and preferred traditional therapy programs over programs using the Wii Fit .
CONCLUSIONS	The usefulness of the Wii Fit as a therapy tool with hospitalised older people is limited not only by the small proportion of older people who are able to use it , but by older people 's preferences for traditional approaches to therapy .
CONCLUSIONS	Mainstream media portrayals of the popularity of the Wii Fit with older people may not reflect the true acceptability in the older hospitalised population .

###24519768
OBJECTIVE	To compare breast cancer incidence and mortality up to 25 years in women aged 40-59 who did or did not undergo mammography screening .
METHODS	Follow-up of randomised screening trial by centre coordinators , the study 's central office , and linkage to cancer registries and vital statistics databases .
METHODS	15 screening centres in six Canadian provinces,1980-85 ( Nova Scotia , Quebec , Ontario , Manitoba , Alberta , and British Columbia ) .
METHODS	89,835 women , aged 40-59 , randomly assigned to mammography ( five annual mammography screens ) or control ( no mammography ) .
METHODS	Women aged 40-49 in the mammography arm and all women aged 50-59 in both arms received annual physical breast examinations .
METHODS	Women aged 40-49 in the control arm received a single examination followed by usual care in the community .
METHODS	Deaths from breast cancer .
RESULTS	During the five year screening period , 666 invasive breast cancers were diagnosed in the mammography arm ( n = 44,925 participants ) and 524 in the controls ( n = 44,910 ) , and of these , 180 women in the mammography arm and 171 women in the control arm died of breast cancer during the 25 year follow-up period .
RESULTS	The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 ( 95 % confidence interval 0.85 to 1.30 ) .
RESULTS	The findings for women aged 40-49 and 50-59 were almost identical .
RESULTS	During the entire study period , 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer , and 500 and 505 , respectively , died of breast cancer .
RESULTS	Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm ( hazard ratio 0.99 , 95 % confidence interval 0.88 to 1.12 ) .
RESULTS	After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm , attributable to over-diagnosis .
CONCLUSIONS	Annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available .
CONCLUSIONS	Overall , 22 % ( 106/484 ) of screen detected invasive breast cancers were over-diagnosed , representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial .

###8193690
OBJECTIVE	To compare two Haemophilus influenzae type B ( HiB ) conjugate vaccines , a polysaccharide-diphtheria toxoid conjugate ( PRP-D ) vaccine and an oligosaccharide-CRM197 protein conjugate ( HBOC [ PRP-CRM ] ) vaccine , in the same population .
METHODS	One hundred twenty-five thousand infants were randomized to receive the PRP-D or HBOC vaccine .
METHODS	Primary immunization consisted of two doses of either vaccine administered at 4 and 6 months and a booster dose was given at 14 to 18 months .
METHODS	Protection was assessed by recording episodes of invasive disease with HiB isolated from the blood or another normally sterile body site .
METHODS	One thousand thirty-six child health care centers in Finland .
METHODS	Infants born in Finland during the 24-month period from 1987 to 1989 .
METHODS	Each vaccine dose was injected intramuscularly in a volume of 0.5 mL .
METHODS	At the same time , a separate site was injected with the diphtheria and tetanus toxoids and pertussis vaccine at 4 months of age , with inactivated poliovirus vaccine at 6 months of age , and with measles-mumps-rubella vaccine at 14 to 18 months of age .
RESULTS	The mean anticapsular antibody concentration 1 month after the second dose was 0.63 micrograms/mL and 4.32 micrograms/mL in the PRP-D and HBOC vaccine recipients , respectively .
RESULTS	The booster dose resulted in a high antibody concentration : 33.3 micrograms/mL and 58.3 micrograms/mL for PRP-D and HBOC vaccine recipients , respectively .
RESULTS	At 36 months of age , the antibody concentration declined to 2.5 micrograms/mL and 5.6 micrograms/mL for PRP-D and HBOC vaccine recipients , respectively .
RESULTS	After two doses of the vaccine , there were five episodes ( 39 were expected based on historical controls ) of invasive HiB disease in the PRP-D group and two episodes ( 35 were expected ) in the HBOC group .
RESULTS	Hence , an 87 % ( 95 % confidence limit [ CL ] , 69 , 96 ) protection rate in the PRP-D group and a 95 % ( 95 % CL , 76 , 99 ) protection rate in the HBOC group were achieved .
RESULTS	No episodes occurred after the booster dose in either group .
CONCLUSIONS	Both the PRP-D and HBOC vaccines are safe and effective .
CONCLUSIONS	A two-dose primary vaccination schedule seems appropriate , at least in circumstances prevailing in Finland and probably in other areas with similar epidemiological effects of HiB disease .

###10383519
BACKGROUND	We investigated the efficacy of 30 vs. 60 mg lansoprazole daily in a 1-week triple therapy for eradication of Helicobacter pylori in a prospective randomized study .
METHODS	Two hundred and fifteen consecutive out-patients with peptic ulcer disease or non-ulcer dyspepsia , in whom H. pylori infection was confirmed by histology and/or a urease biopsy test , were randomly assigned to a 1-week treatment with either 15 mg lansoprazole b.d. ( LAC15 group ) or 30 mg lansoprazole b.d. ( LAC30 group ) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d.
RESULTS	Eradication of H. pylori was successful in 87 % ( per protocol ) and 82 % ( intention-to-treat ) of the patients with LAC15 and in 94 % ( per protocol ) and 87 % ( intention-to-treat ) of the patients with LAC30 .
RESULTS	The difference was not significant .
RESULTS	In both treatment groups , all peptic ulcers were healed at the check-up .
RESULTS	Adverse effects were seen in 11 patients of the LAC15 group and 10 patients of the LAC30 group : they caused discontinuation of the therapy in four of the LAC15 group and two patients of the LAC 30 group .
CONCLUSIONS	A 7-day triple therapy using lansoprazole ( LAC15 ) is an efficient and economical regimen for the eradication of H. pylori .

###11117766
OBJECTIVE	To detect differences in clinical short term outcome between total abdominal hysterectomy , vaginal hysterectomy and laparoscopic assisted vaginal hysterectomy .
METHODS	Randomised controlled trial .
METHODS	Department of Obstetrics and Gynaecology , Hospital of Helsingborg , Sweden .
METHODS	One hundred-twenty women scheduled for hysterectomy for various indications .
METHODS	Randomisation into three treatment arms : total abdominal hysterectomy ( n = 40 ) ; vaginal hysterectomy ( n = 40 ) and laparoscopic assisted vaginal hysterectomy ( n = 40 ) .
METHODS	During traditional abdominal and vaginal surgery , laparoscopic assistance was kept to a minimum .
METHODS	Substantial number of cases needed volume-reducing manoeuvres due to uterine size .
METHODS	Duration of surgery , anaesthesia , time in hospital and recovery time .
RESULTS	Mean duration ( range ) of surgery was significantly longer for laparoscopic assisted vaginal hysterectomy compared with vaginal hysterectomy and total abdominal hysterectomy , 102 min ( 50-175 ) , 81 min ( 35-135 ) and 68 min ( 28-125 ) , respectively .
RESULTS	Mean stay in hospital and mean time to recovery was significantly longer for total abdominal hysterectomy compared with vaginal hysterectomy and laparoscopic assisted vaginal hysterectomy .
RESULTS	The difference between vaginal hysterectomy and laparoscopic assisted vaginal hysterectomy was not significant .
RESULTS	It was possible to remove uteri under 600 g with all three methods .
RESULTS	Four laparoscopic assisted vaginal hysterectomies and one vaginal hysterectomy were converted to open surgery .
RESULTS	Reoperation and blood transfusion were required after two vaginal hysterectomies and one laparoscopic assisted vaginal hysterectomy .
RESULTS	One woman needed blood transfusion after total abdominal hysterectomy .
CONCLUSIONS	Traditional vaginal hysterectomy proved to be feasible and the faster operative technique compared with vaginal hysterectomy with laparoscopic assistance .
CONCLUSIONS	The abdominal technique was somewhat faster , but time spent in theatre was not significantly shorter .
CONCLUSIONS	Abdominal hysterectomy required on average a longer hospital stay of one day and one additional week of convalescence compared with traditional vaginal hysterectomy .
CONCLUSIONS	Vaginal hysterectomy should be a primary method for uterine removal .

###25499939
BACKGROUND	Xuezhikang ( XZK ) is an extract of fermented red yeast rice that has lipid-lowering properties .
OBJECTIVE	To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease .
METHODS	A total of 116 adults with baseline non-high-density lipoprotein cholesterol ( non-HDL-C ) levels of approximately 208mg/dL and low-density lipoprotein cholesterol ( LDL-C ) levels of approximately 175mg/dL were randomized to either placebo or XZK 1200 or 2400mg daily and treated for 12weeks .
RESULTS	A majority of the patients were white ( 53.4 % ) or Asian ( 37.1 % ) .
RESULTS	Daily XZK 1200mg and 2400mg for 4 to 12weeks resulted in statistically significant ( P < .001 ) and clinically meaningful decreases in non-HDL-C ( 24 % reduction ) and LDL-C ( 27 % reduction ) compared with placebo .
RESULTS	XZK treatment at either dose enabled approximately 50 % of subjects to reduce their LDL-C levels by30 % .
RESULTS	Doubling the XZK daily dose from 1200 to 2400mg at treatment week 8 caused an additional 4.6 % reduction in LDL-C .
RESULTS	Significant benefits were also observed across secondary efficacy variables , including total cholesterol ( TC ) , apolipoprotein B ( Apo B ) , triglycerides , HDL-C , the TC/HDL-C ratio , and the Apo B/Apo A-I ratio , at treatment week 8 or 12 .
RESULTS	XZK was safe and well tolerated .
RESULTS	Safety and tolerability profiles were similar across treatment groups .
RESULTS	Most adverse events were gastrointestinal .
RESULTS	No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase .
CONCLUSIONS	Xuezhikang significantly reduced non-HDL-C and LDL-C , and was well tolerated .
CONCLUSIONS	Further , longer-term studies in more diverse patient populations are needed to corroborate these findings .

###19521297
OBJECTIVE	Recurrent , bilateral or unilateral , persistent or transient , mild or profound hearing loss has been reported after spinal anaesthesia .
OBJECTIVE	We studied the effects of the needle type ( Quincke , ballpen , pencil-point spinal needles ) on hearing loss after spinal anaesthesia with the use of pure-tone audiometry .
METHODS	Forty-five ASA physical status I patients scheduled for elective inguinal herniorraphy with spinal anaesthesia were enrolled in the study .
METHODS	The patients were randomly divided into three groups .
METHODS	Group Q ( n = 15 ) patients received spinal anaesthesia through a 25-gauge ( G ) Quincke spinal needle , group B ( n = 15 ) patients received the same through a 25-G ballpen spinal needle and those in group P ( n = 15 ) received the same through a 25-G pencil-point spinal needle .
METHODS	Patients were interviewed about postoperative complaints such as postdural puncture headache , vertigo , nausea-vomiting , transient neurological symptoms and major neurological deficits .
METHODS	Pure-tone audiometry was performed by an audiologist at specific time intervals .
RESULTS	The number of patients who had greater than 10 dB hearing loss in group Q was significantly more than that found in group B and group P at 250 , 500 , 4000 and 6000 Hz on postoperative day 1 .
RESULTS	When group B and group P were compared for change in hearing , no statistically significant difference was detected at any frequency tested .
CONCLUSIONS	Because the use of ballpen and pencil-point needles reduces hearing loss after spinal anaesthesia , these needles are preferred .

###11302295
BACKGROUND	Although psychosocial therapy has been shown to reduce mortality after myocardial infarction , it is unknown whether the benefits of psychosocial therapy on mortality reduction extend to out-of-hospital sudden cardiac arrest , a main cause of cardiovascular mortality .
OBJECTIVE	Describe efficacy of psychosocial therapy on two-year cardiovascular mortality in sudden cardiac arrest survivors .
METHODS	Survivors of out-of-hospital ventricular fibrillation or asystole ( N = 129 ) , documented by electrocardiograms from registries of a citywide Medic One unit and two countywide emergency units , were randomized into a two group , experimental , longitudinal design .
METHODS	The intervention consisted of 11 individual sessions , implementing three components : physiologic relaxation with biofeedback training focused on altering autonomic tone ; cognitive behavioral therapy aimed at self-management and coping strategies for depression , anxiety , and anger ; and cardiovascular health education .
METHODS	The primary outcome measure was cardiovascular mortality .
RESULTS	Risk of cardiovascular death was significantly reduced 86 % by psychosocial therapy , p = .03 .
RESULTS	Six of the seven cardiovascular deaths in the control group were caused by ventricular arrhythmias .
RESULTS	The cardiovascular death in the therapy group was due to stroke .
RESULTS	Controlling for depression , previous myocardial infarction , low ejection fraction , decreased heart rate variability , and ventricular ectopic beats had little impact on estimated treatment effect .
RESULTS	The risk of all-cause mortality was reduced by 62 % in the therapy group , p = .13 .
RESULTS	There were a total of three deaths in the therapy group and eight deaths in the control group .
CONCLUSIONS	Psychosocial therapy significantly reduced the risk of cardiovascular death in sudden cardiac arrest survivors .

###20012857
OBJECTIVE	The Diabetes Aerobic and Resistance Exercise ( DARE ) study showed that aerobic and resistance exercise training each improved glycaemic control and that a combination of both was superior to either type alone in patients with type 2 diabetes mellitus .
OBJECTIVE	Here we report effects on patient-reported health status and well-being in the DARE Trial .
METHODS	We randomised 218 inactive participants with type 2 diabetes mellitus in parallel to 22 weeks of aerobic exercise ( n = 51 ) , resistance exercise ( n = 58 ) , combined aerobic and resistance exercise ( n = 57 ) or no exercise ( control ; n = 52 ) .
METHODS	Intervention allocation was managed by a central office .
METHODS	Outcomes included health status as assessed by the physical and mental component scores of the Medical Outcomes Trust Short-Form 36-item version ( SF-36 ) and well-being as measured by the Well-Being Questionnaire 12-item version ( WBQ-12 ) ; these were measured at the Ottawa Hospital .
RESULTS	Using a p value of 0.0125 for statistical significance due to multiple comparisons , mixed model analyses indicated that resistance exercise led to clinically but not statistically significant improvements in the SF-36 physical component score compared with aerobic exercise ( Delta = 2.7 points ; p = 0.048 ) and control ( i.e. no exercise ; Delta = 3.3 points ; p = 0.015 ) .
RESULTS	For mental component scores , there were clinically important improvements favouring no ( control ) compared with resistance ( Delta = 7.6 points ; p < 0.001 ) and combined ( Delta = 7.2 points ; p < 0.001 ) exercise .
RESULTS	No effects on WBQ-12 scores were noted .
RESULTS	Overall , 59/218 ( 27 % ) of participants included in this analysis sustained an adverse event during the course of the study , including 16 participants in the combined exercise group , 19 participants in the resistance exercise group , 16 participants in the aerobic exercise group , and eight participants in the control group .
RESULTS	All participants were included in the intent-to-treat analyses .
RESULTS	The trial is now closed to follow-up .
CONCLUSIONS	Resistance exercise was better than aerobic or no exercise for improving physical health status in these patients .
CONCLUSIONS	No exercise was superior to resistance or combined exercise for improving mental health status .
CONCLUSIONS	Well-being was unchanged by intervention .
BACKGROUND	ClinicalTrials.gov NCT00195884
BACKGROUND	This study was funded by the Canadian Institutes of Health Research ( grant MCT-44155 ) and the Canadian Diabetes Association ( The Lillian Hollefriend Grant ) .

###15210552
OBJECTIVE	To evaluate the efficacy of a portable low-intensity alternating pressure generator , the Meniett device , in controlling the symptoms of Mnire 's disease .
METHODS	A randomized , placebo-controlled , double-blind , multicenter clinical trial of 4 months ' duration .
METHODS	Four study sites : 3 academic medical centers and 1 private practice .
METHODS	Sixty-seven people aged 33 to 71 years with established , active , unilateral cochleovestibular Mnire 's disease randomly assigned to a treatment or control group .
METHODS	Five cases were excluded ( 2 dropouts , 3 protocol violations ) , leaving 62 evaluable cases .
METHODS	The Meniett device was self-administered 3 times daily .
METHODS	The placebo Meniett device was identical but exerted no pressure .
METHODS	All participants had a tympanostomy tube inserted in the affected ear .
METHODS	Participants rated vertigo and activity each day on a symptom report card .
METHODS	Hearing tests , electrocochleography , and questionnaires were completed at baseline , 2 months , and 4 months .
RESULTS	The treatment group experienced significantly less severe vertigo , fewer days with definitive vertigo , and fewer days lost from work ( sick days ) during the follow-up period than did the control group .
RESULTS	Hearing and electrocochleographic results did not differ between the groups .
RESULTS	Outcomes did not differ by age , gender , laterality , or duration of symptoms .
RESULTS	Outcomes were affected by vestibular loss and baseline level of vertigo .
RESULTS	The tympanostomy tube had no short-term effect on vertigo symptoms .
RESULTS	There were no complications from using the Meniett device .
CONCLUSIONS	The Meniett device is a minimally invasive , safe , and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy .

###20869680
OBJECTIVE	To describe a technique for sonographically guided acromioclavicular joint ( ACJ ) injections and compare its accuracy to palpation-guided injections in a cadaveric model .
METHODS	Prospective laboratory investigation .
METHODS	Procedural skills laboratory at a tertiary medical center .
METHODS	A single experienced operator completed 10 sonographically guided and 10 palpation-guided ACJ injections in unembalmed cadavers .
METHODS	Injection order was randomized and all injections were completed with diluted colored latex .
METHODS	Co-investigators blinded to the injection technique dissected each specimen and graded colored latex location as accurate ( in the ACJ ) , partially accurate ( within and outside the ACJ ) , or inaccurate ( no latex in the ACJ ) .
METHODS	Direct assessment of injected dye within the ACJ via dissection .
RESULTS	All 10 sonographically guided ACJ injections accurately placed latex into the ACJ ( 100 % accuracy ) , whereas only 4 of 10 ( 40 % ) palpation-guided injections accurately placed latex within the ACJ ( P = .0054 ) .
CONCLUSIONS	This cadaveric investigation suggests that sonographic guidance can be used to inject the ACJ with a high degree of accuracy , and should be considered superior to palpation guidance .
CONCLUSIONS	Clinicians should consider using sonographic guidance to inject the ACJ when diagnostic specificity is paramount or when otherwise clinically indicated .

###24372439
OBJECTIVE	To evaluate an individually tailored oral health educational programme on patient-reported outcome compared with a standard oral health educational programme , assess change over time and determine minimal important differences ( MID ) in change scores for two different oral health related quality of life ( OHRQoL ) instrument after non-surgical periodontal treatment ( NSPT ) .
METHODS	In a randomized controlled trial evaluating two educational programmes , patients ( n = 87 ) with chronic periodontitis completed a questionnaire at baseline and after 12 months .
METHODS	OHRQoL was assessed with the General Oral Health Assessment Index ( GOHAI ) and the UK oral health-related quality-of-life measure ( OHQoL-UK ) .
METHODS	In addition , patients ' global rating of oral health and socio-demographic variables were recorded .
METHODS	The MID was estimated with anchor-based and distributions-based methods .
RESULTS	There were no differences between the two educational groups .
RESULTS	The OHRQoL was significantly improved after treatment .
RESULTS	The MID was approximately five for OHQoL-UK with a moderate ES , and three for GOHAI with a Small ES , and 46-50 % of the patients showed improvements beyond the MID .
CONCLUSIONS	Both oral health educational groups reported higher scores in OHRQoL after NSPT resulting in more positive well-being ( OHQoL-UK ) and less frequent oral problems ( GOHAI ) .
CONCLUSIONS	OHQoL-UK gave a greater effect size and mean change scores but both instruments were associated with the participants ' self-rated change in oral health .
CONCLUSIONS	The changes were meaningful for the patients supported by the estimated MID .

###18068058
OBJECTIVE	Pain after coronary artery bypass graft ( CABG ) surgery remains a significant problem and may cause serious complications because of restricted breathing and limited early mobilization .
OBJECTIVE	The aim of this study was to assess the effects of intrapleural analgesia on the relief of postoperative pain in patients undergoing CABG surgery .
METHODS	Postoperative pain , pulmonary function tests , and outcomes were compared with a placebo group after CABG surgery in a double-blind randomized clinical trial .
METHODS	Cardiovascular surgery clinic .
METHODS	One hundred twenty-five patients with decreased lung function were studied .
METHODS	Group A ( 62 patients ) received 20 mL of 0.5 % bupivacaine bilaterally in the intrapleural spaces every 6 hours for 4 days , and group B ( 63 placebo patients ) received sterile saline solution .
RESULTS	Group A had a significantly shorter extubation time than the placebo group ( 8 + / - 1 h v 10 + / - 4 hours , p < 0.001 ) .
RESULTS	Blood gas analysis showed higher PaO2 and lower PaCO2 levels in group A.
RESULTS	The patients receiving bupivicaine had significantly higher FEV1 , FCV , VC , MVV , PEF , and FEF 25-75 % values postoperatively when compared with the placebo group .
RESULTS	Postoperative analgesic requirements and visual analog pain scales were significantly lower in group A.
RESULTS	The intensive care unit stay in group A was shorter ( 1.2 + / - 0.7 v 1.4 + / - 0.6 days , p = 0.04 ) ; however , the hospital stay did not differ between groups .
CONCLUSIONS	Improvement in lung function parameters correlating with decreased postoperative pain with intrapleural bupivacaine was observed .
CONCLUSIONS	Intrapleural analgesia provided a good level of analgesia , improved respiratory performance , and allowed rapid mobilization , which led to a reduction of postoperative respiratory complications .

###17161766
BACKGROUND	To attain goal blood pressure ( BP ) , many hypertensive patients require combination antihypertensive therapy .
BACKGROUND	Thiazide diuretic/beta-blocker regimens lower BP , and clinical studies indicate that they reduce the risk for cardiovascular consequences of hypertension .
BACKGROUND	Fixed-dose combination tablets can simplify multidrug treatment regimens .
METHODS	This multicenter , randomized , double-blind , placebo-controlled , unbalanced factorial study ( N = 1571 ) was designed to determine whether hydrochlorothiazide ( HCT ) and extended release ( ER ) metoprolol both contribute to an antihypertensive effect .
METHODS	Hypertensive adults with sitting diastolic BP ( SiDBP ) 95 to 114 mm Hg and systolic BP ( SiSBP ) < 180 mm Hg received one of three hydrochlorothiazide doses ( 6.25 mg , 12.5 mg , or 25 mg ) , one of four ER-metoprolol doses ( 25 mg , 50 mg , 100 mg , 200 mg ) , or one of nine of the combinations or placebo for 8 weeks .
RESULTS	Blood pressure decreased with all combinations ( P < .001 v placebo ) ; reductions were dose related , ranging from 8.7 to 15.7 mm Hg ( SiDBP ) and 9.7 to 18.9 mm Hg ( SiSBP ) ( model-derived values ) .
RESULTS	Reductions with placebo were 5.3 ( SiDBP ) and 4.2 mm Hg ( SiSBP ) .
RESULTS	Both active agents contributed to the combination effect ( P = .0015 for SiDBP ; P = .0006 for SiSBP ) .
RESULTS	Several low-dose combinations were approximately as effective as high doses of the individual agents ( differences within 1 to 2.5 mm Hg ) .
RESULTS	The adverse event discontinuation rate was 2.9 % .
RESULTS	Serum potassium decreased and uric acid increased with increasing doses of HCT .
CONCLUSIONS	Extended-release metoprolol/hydrochlorothiazide is an effective antihypertensive combination that offers additive antihypertensive contributions from both components .

###12866330
BACKGROUND	Continuing medical education ( CME ) for physicians and other health personnel is becoming increasingly important in light of recertification requirements .
BACKGROUND	Interactive learning is more effective and may be useful in a continuing education setting .
BACKGROUND	This study examines the use of an audience response system ( ARS ) as an interactive learning tool for health care providers .
METHODS	We conducted a national randomized controlled trial to evaluate the utility of an ARS to enhance attention and learning .
METHODS	Speakers at 42 clinical round table ( CRT ) programs in five regions across the United States were randomized to `` use '' or `` no use '' of an ARS during their lectures .
METHODS	We surveyed participants to collect data regarding presentation and speaker quality , impressions of the ARS , and knowledge of the material presented .
METHODS	We collected information from speakers regarding ease of use and overall opinions of the ARS .
RESULTS	A total of 283 surveys were completed ( 164 from participants using the ARS and 119 from participants not using the ARS ) .
RESULTS	ARS participants rated the quality of the presentation , the quality of the speaker , and their level of attention more highly than non-ARS participants ( p < .05 ) .
RESULTS	Knowledge scores ( of material presented ) were not significantly different between the two groups .
RESULTS	Both participants and speakers felt that the ARS was easy to use and preferred to use the system in future CRTs .
CONCLUSIONS	Participants in CRTs with the ARS rated presentation and speaker quality more favorably than those participants in CRTs without the tool .
CONCLUSIONS	Participant knowledge scores , however , were not significantly different .
CONCLUSIONS	ARSs may provide easy-to-use tools to enhance attention and enthusiasm in CME learners .

###16542207
OBJECTIVE	To evaluate the efficacy and safety of tramadol in patients with idiopathic detrusor overactivity ( IDO ) .
METHODS	A total of 76 patients 18 years or older with IDO were randomly assigned to receive 100 mg tramadol sustained release ( group 1 , n = 38 ) or placebo ( group 2 , n = 38 ) every 12 h for 12 weeks .
METHODS	Clinical evaluation was performed at baseline and every 2 weeks during treatment .
METHODS	All patients underwent urodynamics and ice water test at baseline and 12-week treatment .
METHODS	Main outcome measures were number of voids per 24 h , urine volume per void and episodes of urge incontinence per 24 h on a frequency volume chart and detailed recording of adverse effect .
RESULTS	After 12 weeks of treatment mean number of voids per 24 h + / - SD decreased from 9.3 + / - 3.2 to 5.1 + / - 2.1 ( P < 0.001 vs. placebo ) [ 95 % confidence interval ( CI ) -5.1 -- 0.4 ] .
RESULTS	At that time mean urine volume per void increased from 158 + / - 32 to 198 + / - 76 ml ( P < 0.001 vs. placebo ) ( 95 % CI 8-22 ) , while mean number of incontinence episodes per 24 h decreased from 3.2 + / - 3.3 to 1.6 + / - 2.8 ( P < 0.001 vs. placebo ) ( 95 % CI -2 -0.3 ) .
RESULTS	Tramadol induced significant improvements in urodynamic parameters .
RESULTS	More adverse effects were associated with tramadol treatment than with placebo ( P < 0.05 ) .
RESULTS	The main adverse event with tramadol was nausea .
CONCLUSIONS	In patients with non-neurogenic IDO tramadol provided beneficial clinical and urodynamic results .
CONCLUSIONS	Further studies are required to draw final conclusions on the efficacy of this drug in IDO .

###15883439
BACKGROUND	Low intake of dietary fat and high intake of soy foods have been suggested to partly explain the lower breast cancer rates in Asia , perhaps because of lower endogenous estrogens .
OBJECTIVE	The objective was to assess the hormonal and nonhormonal effects of diets resembling an Asian diet in terms of total fat and soy food contents .
METHODS	Fifty-seven postmenopausal women participated in a randomized , controlled , dietary intervention study .
METHODS	The subjects consumed a very-low-fat diet ( VLFD ; 11 % of energy as fat ) , a Step I diet ( 25 % of energy as fat ) supplemented with soy food ( SFD ; 50 mg isoflavones/d ) , or a control Step I diet ( CD ; 27 % of energy as fat ) with no soy food .
METHODS	All diets were prepared at the General Clinical Research Center of the University of Southern California .
METHODS	Serum hormones and other markers were measured at baseline and every 2 wk during the 8 wk of intervention .
RESULTS	There were no significant differences in total estradiol and sex hormone binding globulin at the completion of the intervention between women in the SFD and VLFD groups and those in the CD group .
RESULTS	Serum insulin decreased significantly in the SFD group , and leptin decreased significantly in the SFD and VLFD groups ; however , these changes did not differ significantly from the changes in the CD group .
CONCLUSIONS	This study does not provide evidence that ingestion of soy food or a VLFD significantly reduces estrogen concentrations in postmenopausal women .
CONCLUSIONS	However , short-term changes in diet may have significant and beneficial effects on blood insulin and leptin concentrations .

###21481253
BACKGROUND	Obese adults struggle to make the changes necessary to achieve even modest weight loss , though a decrease in weight by as little as 10 % can have significant health benefits .
BACKGROUND	Failure to meet weight loss goals may in part be associated with barriers to obesity treatment .
BACKGROUND	Wide-spread dissemination of evidence-based obesity treatment faces multiple challenges including cost , access , and implementing the programmatic characteristics on a large scale .
OBJECTIVE	The PDA + : A Personal Digital Assistant for Obesity Treatment randomized controlled trial ( RCT ) was designed to test whether a PDA-based behavioral intervention enhances the effectiveness of the existing group weight loss treatment program at VA Medical Centers Managing Overweight/Obese Veterans Everywhere ( MOVE ! )
OBJECTIVE	We also aim to introduce technology as a way to overcome systemic barriers of traditional obesity treatment .
METHODS	Veterans enrolled in the MOVE !
METHODS	group at the Hines Hospital VAMC with BMI 25 and 40 and weigh < 400 pounds , experience chronic pain ( 4 on the NRS-I scale for 6 months prior to enrollment ) and are able to participate in a moderate intensity exercise program will be recruited and screened for eligibility .
METHODS	Participants will be randomized to receive either : a ) MOVE !
METHODS	treatment alone ( Standard Care ) or b ) Standard Care plus PDA ( PDA + ) .
METHODS	Those randomized to PDA + will record dietary intake , physical activity , and weight on the PDA .
METHODS	In addition , they will also record mood and pain intensity , and receive biweekly telephone support for the first 6-months of the 12-month study .
METHODS	All participants will attend in-person lab sessions every three months to complete questionnaires and for the collection of anthropomorphic data .
METHODS	Weight loss and decrease in pain level intensity are the primary outcomes .
CONCLUSIONS	The PDA + trial represents an important step in understanding ways to improve the use of technology in obesity treatment .
CONCLUSIONS	The trial will address barriers to obesity care by implementing effective behavioral components of a weight loss intervention and delivering high intensity , low cost obesity treatment .
CONCLUSIONS	This RCT also tests an intervention approach supported by handheld technology in a population traditionally considered to have lower levels of technology literacy .
BACKGROUND	ClinicalTrials.gov : NCT00371462 .

###10514160
OBJECTIVE	To compare the clinical effectiveness of local corticosteroid injection , standard non-steroidal anti-inflammatory drugs , and simple analgesics for the early treatment of lateral epicondylitis in primary care .
METHODS	Multicentre pragmatic randomised controlled trial .
METHODS	23 general practices in North Staffordshire and South Cheshire .
METHODS	164 patients aged 18-70 years presenting with a new episode of lateral epicondylitis .
METHODS	Local injection of 20 mg methylprednisolone plus lignocaine , naproxen 500 mg twice daily for two weeks , or placebo tablets .
METHODS	All participants received a standard advice sheet and co-codamol as required .
METHODS	Participants ' global assessment of improvement ( five point scale ) at four weeks .
METHODS	Pain , function , and `` main complaint '' measured on 10 point Likert scales at 4 weeks , 6 months , and 12 months .
RESULTS	Over 2 years , 53 subjects were randomised to injection , 53 to naproxen , and 58 to placebo .
RESULTS	Prognostic variables were similar between groups at baseline .
RESULTS	At 4 weeks , 48 patients ( 92 % ) in the injection group were completely better or improved compared with 30 ( 57 % ) in the naproxen group ( P < 0.001 ) and 28 ( 50 % ) in the placebo group ( P < 0.001 ) .
RESULTS	At 12 months , 43 patients ( 84 % ) in the injection group had pain scores < / = 3 compared with 45 ( 85 % ) in the naproxen group and 44 ( 82 % ) in the placebo group ( P > 0.05 ) .
CONCLUSIONS	Early local corticosteroid injection is effective for lateral epicondylitis .
CONCLUSIONS	Outcome at one year was good in all groups , and effective early treatment does not seem to influence this .

###25224684
BACKGROUND	Olfactory dysfunction is deemed to be a significant contributor to poor quality of life in chronic rhinosinusitis ( CRS ) .
OBJECTIVE	To assess and to compare the effectiveness of three modalities of corticosteroids administration in patients with CRS .
METHODS	A prospective randomized controlled study
METHODS	Thirty patients with CRS were randomized in three groups depending on the route of corticosteroids administration : 16 days by oral route ( Medrol ( Pfizer , Belgique ) , 32 mg/8 days -16 mg/4 days-8 mg/4 days ) ; nasal spray ( Rhinocort ( AstraZeneca , Belgique ) , 2 2 64 g/nostril ) ; or sonic nebulization ( Pulmicort ( AstraZeneca , Belgique ) , 2 1 mg/4 mL ) ( Sonic nebulizer , AOHBOX-NL11SN , DTF , France ) .
METHODS	Olfactory function was assessed using orthonasal threshold discrimination identification and retronasal psychophysical olfactory tests ( RNT ) before and after the treatment .
METHODS	Same intranasal modalities were previously tested for in vitro airways scintigraphic deposition .
RESULTS	In vitro differences in drug deposition pattern between both intranasal modalities were demonstrated .
RESULTS	Threshold discrimination identification and RNT were similar between three groups at baseline .
RESULTS	Threshold discrimination identification improved by 5.5 , 5.8 , and -1.1 for sonic nebulization , oral , and nasal spray groups , respectively ( P = 0.010 ) .
RESULTS	This improvement was clinically relevant for oral and nebulized administration .
RESULTS	It was similar between oral and nebulized administration but significantly higher than nasal spray administration .
RESULTS	Retronasal psychophysical olfactory tests improved similarly for the three groups ( P = 0.231 ) CONCLUSION : Effectiveness of sonic nebulized and oral administration is demonstrated on orthonasal olfactory .
RESULTS	The clinical benefit is better than with nasal spray .

###23033237
OBJECTIVE	To assess the possibility of improving nocturnal glycemic control as well as meal glycemic response using closed-loop therapy in children aged < 7 years .
METHODS	This was a randomized controlled crossover trial comparing closed-loop with standard open-loop insulin pump therapy performed in an inpatient clinical research center .
METHODS	Ten subjects aged < 7 years with type 1 diabetes for > 6 months treated with insulin pump therapy were studied .
METHODS	Closed-loop therapy and standard open-loop therapy were compared from 10:00 p.m. to 12:00 p.m. on 2 consecutive days .
METHODS	The primary outcome was plasma glucose time in range ( 110-200 mg/dL ) during the night ( 10:00 p.m.-8 :00 a.m. ) .
METHODS	Secondary outcomes included peak postprandial glucose levels , incidence of hypoglycemia , degree of hyperglycemia , and prelunch glucose levels .
RESULTS	A trend toward a higher mean nocturnal time within target range was noted for closed - versus open-loop therapy , although not reaching statistical significance ( 5.3 vs. 3.2 h , P = 0.12 ) .
RESULTS	There was no difference in peak postprandial glucose or number of episodes of hypoglycemia .
RESULTS	There was significant improvement in time spent > 300 mg/dL overnight with closed-loop therapy ( 0.18 vs. 1.3 h , P = 0.035 ) and the total area under the curve of glucose > 200 mg/dL ( P = 0.049 ) .
RESULTS	Closed-loop therapy returned prelunch blood glucose closer to target ( 189 vs. 273 mg/dL on open loop , P = 0.009 ) .
CONCLUSIONS	Closed-loop insulin delivery decreases the severity of overnight hyperglycemia without increasing the incidence of hypoglycemia .
CONCLUSIONS	The therapy is better able to reestablish target glucose levels in advance of a subsequent meal .
CONCLUSIONS	Younger children with type 1 diabetes may reap significant benefits from closed-loop therapy .

###21689865
OBJECTIVE	We determine whether aerosolized intranasal or buccal midazolam reduces the distress of pediatric laceration repair compared with oral midazolam .
METHODS	Children aged 0.5 to 7 years and needing nonparenteral sedation for laceration repair were randomized to receive oral , aerosolized intranasal , or aerosolized buccal midazolam .
METHODS	Patient distress was rated by blinded review of videotapes , using the Children 's Hospital of Eastern Ontario Pain Score .
METHODS	Secondary outcomes included activity scores , sedation adequacy , sedation onset , satisfaction , and adverse events .
RESULTS	For the 169 subjects ( median age 3.1 years ) evaluated for the primary outcome , we found significantly less distress in the buccal midazolam group compared with the oral route group ( P = .04 ; difference -2 ; 95 % confidence interval -4 to 0 ) and a corresponding nonsignificant trend for the intranasal route ( P = .08 ; difference -1 ; 95 % confidence interval -3 to 1 ) .
RESULTS	Secondary outcomes ( 177 subjects ) favored the intranasal group , including a greater proportion of patients with an optimal activity score ( 74 % ) , a greater proportion of parents wanting this sedation in the future , and faster sedation onset .
RESULTS	Intranasal was the route least tolerated at administration .
RESULTS	Adverse events were similar between groups .
CONCLUSIONS	When comparing the administration of midazolam by 3 routes to facilitate pediatric laceration repair , we observed slightly less distress in the aerosolized buccal group .
CONCLUSIONS	The intranasal route demonstrated a greater proportion of patients with optimal activity scores , greater proportions of parents wanting similar sedation in the future , and faster onset but was also the most poorly tolerated at administration .
CONCLUSIONS	Aerosolized buccal or intranasal midazolam represents an effective and useful alternative to oral midazolam for sedation for laceration repair .

###19371497
OBJECTIVE	For important reasons , lorazepam ( Ativan ) and chlordiazepoxide ( Librium ) are both popular treatments for alcohol-withdrawal syndrome .
OBJECTIVE	Nevertheless , there is little literature directly comparing the two drugs .
OBJECTIVE	A formal comparison is desirable because of pharmacokinetic and other differences that could affect safety and efficacy considerations relevant to practice in developing countries .
METHODS	One hundred consecutive consenting male inpatients in a state of moderately severe , uncomplicated alcohol withdrawal at screening were randomized to receive either lorazepam ( 8 mg/day ) or chlordiazepoxide ( 80 mg/day ) with dosing down-titrated to zero in a fixed-dose schedule across 8 treatment days .
METHODS	Double-blind assessments of withdrawal-symptom severity and impairing adverse events were obtained during treatment and for 4 days afterward .
RESULTS	One chlordiazepoxide patient developed withdrawal delirium .
RESULTS	Lorazepam and chlordiazepoxide showed similar efficacy in reducing symptoms of alcohol withdrawal as assessed using the revised Clinical Institute Withdrawal Assessment for Alcohol scale .
RESULTS	During withdrawal , irritability and dizziness were more common with lorazepam , and palpitations were more common with chlordiazepoxide .
RESULTS	No difficulties in drug discontinuation or differences in impairing adverse events were observed with either drug .
CONCLUSIONS	With the treatment schedule used in this study , lorazepam is as effective as the more traditional drug chlordiazepoxide in attenuating uncomplicated alcohol withdrawal .
CONCLUSIONS	Lorazepam , therefore , could be used with confidence when liver disease or the inability to determine liver function status renders chlordiazepoxide therapy problematic .
CONCLUSIONS	The absence of clinically significant withdrawal complications with lorazepam in this large study contrasts with findings from previously published studies and suggests that higher doses of lorazepam than those formerly used may be necessary during alcohol withdrawal .

###21914755
OBJECTIVE	To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short ( 6 weeks ) , intermediate ( 12 weeks ) , and long term ( 52 weeks ) .
METHODS	Multicentre , blinded , randomised controlled trial .
METHODS	Outpatient multidisciplinary back clinics of five Norwegian hospitals .
METHODS	Between October 2005 and February 2009 , 461 patients assessed for inclusion ( presenting with lumbar radiculopathy > 12 weeks ) .
METHODS	328 patients excluded for cauda equina syndrome , severe paresis , severe pain , previous spinal injection or surgery , deformity , pregnancy , ongoing breast feeding , warfarin therapy , ongoing treatment with non-steroidal anti-inflammatory drugs , body mass index > 30 , poorly controlled psychiatric conditions with possible secondary gain , and severe comorbidity .
METHODS	Subcutaneous sham injections of 2 mL 0.9 % saline , caudal epidural injections of 30 mL 0.9 % saline , and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9 % saline .
METHODS	Participants received two injections with a two week interval .
METHODS	Primary : Oswestry disability index scores .
METHODS	Secondary : European quality of life measure , visual analogue scale scores for low back pain and for leg pain .
RESULTS	Power calculations required the inclusion of 41 patients per group .
RESULTS	We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation .
RESULTS	All groups improved after the interventions , but we found no statistical or clinical differences between the groups over time .
RESULTS	For the sham group ( n = 40 ) , estimated change in the Oswestry disability index from the adjusted baseline value was -4.7 ( 95 % confidence intervals -0.6 to -8.8 ) at 6 weeks , -11.4 ( -6.3 to -14.5 ) at 12 weeks , and -14.3 ( -10.0 to -18.7 ) at 52 weeks .
RESULTS	For the epidural saline intervention group ( n = 39 ) compared with the sham group , differences in primary outcome were -0.5 ( -6.3 to 5.4 ) at 6 weeks , 1.4 ( -4.5 to 7.2 ) at 12 weeks , and -1.9 ( -8.0 to 4.3 ) at 52 weeks ; for the epidural steroid group ( n = 37 ) , corresponding differences were -2.9 ( -8.7 to 3.0 ) , 4.0 ( -1.9 to 9.9 ) , and 1.9 ( -4.2 to 8.0 ) .
RESULTS	Analysis adjusted for duration of leg pain , back pain , and sick leave did not change this trend .
CONCLUSIONS	Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy .
CONCLUSIONS	Trial registration Current Controlled Trials ISRCTN No 12574253 .

###16840742
BACKGROUND	Hyperoxia and normoxic helium independently reduce dynamic hyperinflation and improve the exercise tolerance of patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Combining these gases could have an additive effect on dynamic hyperinflation and a greater impact on respiratory mechanics and exercise tolerance .
OBJECTIVE	To investigate whether helium-hyperoxia improves the exercise tolerance and respiratory mechanics of patients with COPD .
METHODS	Ten males with COPD ( FEV ( 1 ) = 47 + / - 17 % pred [ mean + / - SD ] ) performed randomized constant-load cycling at 60 % of maximal work rate breathing air , hyperoxia ( 40 % O ( 2 ) , 60 % N ( 2 ) ) , normoxic helium ( 21 % O ( 2 ) , 79 % He ) , or helium-hyperoxia ( 40 % O ( 2 ) , 60 % He ) .
METHODS	Exercise time , inspiratory capacity ( IC ) , work of breathing , and exertional symptoms were measured with each gas .
RESULTS	Compared with air ( 9.4 + / - 5.2 min ) , exercise time was increased with hyperoxia ( 17.8 + / - 5.8 min ) and normoxic helium ( 16.7 + / - 9.1 min ) but the improvement with helium-hyperoxia ( 26.3 + / - 10.6 min ) was greater than both these gases ( p = 0.019 and p = 0.007 , respectively ) .
RESULTS	At an isotime during exercise , all three gases reduced dyspnea and both helium mixtures increased IC and tidal volume .
RESULTS	Only helium-hyperoxia significantly reduced the resistive work of breathing ( 15.8 + / - 4.2 vs. 10.1 + / - 4.1 L .
RESULTS	cm H ( 2 ) O ( -1 ) ) and the work to overcome intrinsic positive end-expiratory pressure ( 7.7 + / - 1.9 vs. 3.6 + / - 2.1 L .
RESULTS	cm H ( 2 ) O ( -1 ) ) .
RESULTS	At symptom limitation , tidal volume remained augmented with both helium mixtures , but IC and the work of breathing were unchanged compared with air .
CONCLUSIONS	Combining helium and hyperoxia delays dynamic hyperinflation and improves respiratory mechanics , which translates into added improvements in exercise tolerance for patients with COPD .

###24878273
OBJECTIVE	The development of minimally invasive surgical techniques is driven by the quest for better patient outcomes .
OBJECTIVE	There is some evidence for the use of minimally invasive surgery for degenerative lumbar spine stenosis ( LSS ) , but there are currently no studies comparing outcomes with matched controls .
OBJECTIVE	The object of this study was to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression ( ULBD ) to a standard `` open '' laminectomy for LSS .
METHODS	The authors conducted a prospective , 1:1 randomized trial comparing ULBD to open laminectomy for degenerative LSS .
METHODS	The study enrolled 79 patients between 2007 and 2009 , and adequate data for analysis were available in 54 patients ( 27 in each arm of the study ) .
METHODS	Patient demographic characteristics and clinical characteristics were recorded and clinical outcomes were obtained using pre - and postoperative Oswestry Disability Index ( ODI ) scores , visual analog scale ( VAS ) scores for leg pain , patient satisfaction index scores , and postoperative 12-Item Short Form Health Survey ( SF-12 ) scores .
RESULTS	Significant improvements were observed in ODI and VAS scores for both open and ULBD interventions ( p < 0.001 for both groups using either score ) .
RESULTS	In addition , the ULBD-treated patients had a significantly better mean improvement in the VAS scores ( p = 0.013 ) but not the ODI scores ( p = 0.055 ) compared with patients in the open-surgery group .
RESULTS	ULBD-treated patients had a significantly shorter length of postoperative hospital stay ( 55.1 vs. 100.8 hours , p = 0.0041 ) and time to mobilization ( 15.6 vs. 33.3 hours , p < 0.001 ) and were more likely to not use opioids for postoperative pain ( 51.9 % vs. 15.4 % , p = 0.046 ) .
CONCLUSIONS	Based on short-term follow-up , microscopic ULBD is as effective as open decompression in improving function ( ODI score ) , with the additional benefits of a significantly greater decrease in pain ( VAS score ) , postoperative recovery time , time to mobilization , and opioid use .

###14616184
OBJECTIVE	To assess the validity of the French version of the Modified Reasons for Smoking Scale ( MRSS ) , and to identify which smoking patterns differentiate male and female smokers , which are related to tobacco dependence ( as assessed by the Fagerstrm Test for Nicotine Dependence , FTND ) , to mood ( Beck Depression Inventory II ) , to affect ( Positive and Negative Affect Schedule ) and which are predictors of successful quitting .
METHODS	Three hundred and thirty smokers [ ( mean + / - SD ) aged 40 + / - 9 years , 145 ( 44 % ) women , mean FTND score : 6.2 + / - 2 ] , candidates for a smoking cessation programme and smoking at least 15 cigarettes/day .
RESULTS	Factor analysis of the 21-item scale gave the optimal fit for a seven-factor model , which accounted for 62.3 % of the total variance .
RESULTS	The following factors were identified : ` addictive smoking ' , ` pleasure from smoking ' , ` tension reduction/relaxation ' , ` social smoking ' , ` stimulation ' , ` habit/automatism ' and ` handling ' .
RESULTS	The ` addictive smoking ' score increased in a dose-dependent manner with number of cigarettes smoked per day ; the ` habit/automatism ' score was significantly higher , with more than 20 cigarettes per day than with < or = 20 cigarettes per day .
RESULTS	The reasons for smoking were different for males and females : females scored higher on ` tension reduction/relaxation ' , ` stimulation ' and ` social smoking ' .
RESULTS	A high level of dependence ( FTND > or = 6 ) was associated with significantly higher scores only on ` addictive smoking ' , the association being stronger in females .
RESULTS	Time to first cigarette after awakening was associated with higher ` addictive smoking ' and ` habit/automatism ' ( P < 0.001 ) .
RESULTS	In a multivariate logistic regression , failed quitting was predicted by higher habit/automatism score ( odds ratio = 1.44 , 95 % CI = 1.06-1 .95 , P = 0.02 ) and greater number of cigarettes smoked per day ( odds ratio = 1.03 , 95 % CI = 1.01-1 .06 , p = 0.03 ) .
CONCLUSIONS	The questionnaire yielded a coherent factor structure ; women smoked more for tension reduction/relaxation , stimulation and for social reasons than men ; addictive smoking and automatic smoking behaviour were similar in both sexes and were associated strongly with a high level of nicotine dependence ; the ` habit/automatism ' score predicted failure to quit over and above cigarettes per day .

###15169686
OBJECTIVE	The effect of antipsychotic medication on neurocognitive function remains controversial , especially since most previous work has compared the effects of novel antipsychotic medications with those of high doses of conventional medications .
OBJECTIVE	This study compares the neurocognitive effects of olanzapine and low doses of haloperidol in patients with first-episode psychosis .
METHODS	Patients with a first episode of schizophrenia , schizoaffective disorder , or schizophreniform disorder ( N = 167 ) were randomly assigned to double-blind treatment with olanzapine ( mean modal dose = 9.63 mg/day ) or haloperidol ( mean modal dose = 4.60 mg/day ) for the 12-week acute phase of a 2-year study .
METHODS	The patients were assessed with a battery of neurocognitive tests at baseline and 12 weeks after beginning treatment .
RESULTS	An unweighted neurocognitive composite score , composed of measures of verbal fluency , motor functions , working memory , verbal memory , and vigilance , improved significantly with both haloperidol and olanzapine treatment ( effect sizes of 0.20 and 0.36 , respectively , no significant difference between groups ) .
RESULTS	A weighted composite score developed from a principal-component analysis of the same measures improved to a significantly greater degree with olanzapine , compared with haloperidol .
RESULTS	Anticholinergic use , extrapyramidal symptoms , and estimated IQ had little effect on the statistical differentiation of the medications , although duration of illness had a modest effect .
RESULTS	The correlations of cognitive improvement with changes in clinical characteristics and with side effects of treatment were significant for patients who received haloperidol but not for patients who received olanzapine .
CONCLUSIONS	Olanzapine has a beneficial effect on neurocognitive function in patients with a first episode of psychosis .
CONCLUSIONS	However , in a comparison of the effects of olanzapine and low doses of haloperidol , the difference in benefit is small .

###9176539
BACKGROUND	The main adverse effects of beta 1 agonists relate to their systemic activity .
BACKGROUND	The time course and dose response relations of the systemic effects of salmeterol compared with salbutamol were investigated .
METHODS	A double blind , randomised , crossover study was carried out in 14 healthy subjects who attended on seven days .
METHODS	Heart rate , QTc interval , blood pressure , plasma potassium and glucose concentrations were measured for four hours following inhaled placebo , salmeterol 100 , 200 and 400 micrograms and salbutamol 600 , 1200 and 2400 micrograms given by metered dose inhaler .
METHODS	Maximum changes from baseline and maximum absolute values following each dose of treatment were used to construct log dose response curves and calculate relative dose potency .
RESULTS	Both salmeterol and salbutamol caused dose dependent changes in heart rate , QTc interval , and plasma potassium and glucose concentrations .
RESULTS	The onset of cardiac effects was rapid following both drugs , whereas changes in glucose and potassium concentrations occurred more gradually with salmeterol .
RESULTS	The increase in heart rate and fall in potassium level were sustained over the four hours whereas glucose levels gradually returned towards baseline .
RESULTS	The relative dose potency of salmeterol compared with salbutamol for changes from baseline was 7.1 ( 95 % CI 3.9 to 14.4 ) for the QTc interval and 8.2 ( 95 % CI 5.7 to 12.6 ) for plasma potassium concentration .
RESULTS	Salmeterol caused steeper dose response curves for heart rate and plasma glucose concentration than salbutamol so relative dose potency values could not be calculated .
CONCLUSIONS	These findings support previous data that salmeterol 100 micrograms is broadly equivalent to salbutamol 800 micrograms for systemic effects .
CONCLUSIONS	The greater systemic effects of salmeterol are most likely to be due to greater potency relative to dose , although it may also have greater systemic bioavailability .
CONCLUSIONS	The steeper dose response curve for heart rate with salmeterol indicates that it has a narrower therapeutic window than salbutamol and thus should be prescribed at the lowest effective dose .

###10527076
OBJECTIVE	To evaluate the impact of a program of muscle strengthening and physical conditioning on impairment and disability in chronic stroke subjects .
METHODS	A randomized pretest and posttest control group , followed by a single-group pretest and posttest design .
METHODS	Thirteen community-dwelling stroke survivors of at least 9 months .
METHODS	A 10-week ( 3 days/week ) program consisting of a warm-up , aerobic exercises , lower extremity muscle strengthening , and a cool-down .
METHODS	Peak isokinetic torque of the major muscle groups of the affected lower limb , quadriceps and ankle plantarflexor spasticity , gait speed , rate of stair climbing , the Human Activity Profile ( HAP ) , and the Nottingham Health Profile ( NHP ) were recorded twice for the treatment group and three times for the control group .
RESULTS	Significant improvements were found for all the selected outcome measures ( HAP , NHP , and gait speed ) for the treatment group ( p < .001 ) .
RESULTS	In terms of overall training effects , the 13 subjects demonstrated increases in strength of the affected major muscle groups , in HAP and NHP profiles , and in gait speed and rate of stair climbing without concomitant increases in either quadriceps or ankle plantarflexor spasticity .
CONCLUSIONS	The 10-week combined program of muscle strengthening and physical conditioning resulted in gains in all measures of impairment and disability .
CONCLUSIONS	These gains were not associated with measurable changes of spasticity in either quadriceps or ankle plantarflexors .

###18809631
OBJECTIVE	To evaluate the dipeptidyl peptidase-4 ( DPP-4 ) inhibitor alogliptin in drug-nave patients with inadequately controlled type 2 diabetes .
METHODS	This double-blind , placebo-controlled , multicenter study included 329 patients with poorly controlled diabetes randomized to once-daily treatment with 12.5 mg alogliptin ( n = 133 ) , 25 mg alogliptin ( n = 131 ) , or placebo ( n = 65 ) for 26 weeks .
METHODS	Primary efficacy end point was mean change from baseline in A1C at the final visit .
RESULTS	At week 26 , mean change in A1C was significantly greater ( P < 0.001 ) for 12.5 mg ( -0.56 % ) and 25 mg ( -0.59 % ) alogliptin than placebo ( -0.02 % ) .
RESULTS	Reductions in fasting plasma glucose were also greater ( P < 0.001 ) in alogliptin-treated patients than in those receiving placebo .
RESULTS	Overall , incidences of adverse events ( 67.4-70 .3 % ) and hypoglycemia ( 1.5-3 .0 % ) were similar across treatment groups .
CONCLUSIONS	Alogliptin monotherapy was well tolerated and significantly improved glycemic control in patients with type 2 diabetes , without raising the incidence of hypoglycemia .

###22790614
BACKGROUND	Up to 50 % of patients do not take medications as prescribed .
BACKGROUND	Interventions to improve adherence are needed , with an understanding of which patients benefit most .
OBJECTIVE	To test the effect of two low-literacy interventions on medication adherence .
METHODS	Randomized controlled trial , 22 factorial design .
METHODS	Adults with coronary heart disease in an inner-city primary care clinic .
METHODS	For 1 year , patients received usual care , refill reminder postcards , illustrated daily medication schedules , or both interventions .
METHODS	The primary outcome was cardiovascular medication refill adherence , assessed by the cumulative medication gap ( CMG ) .
METHODS	Patients with CMG < 0.20 were considered adherent .
METHODS	We assessed the effect of the interventions overall and , post-hoc , in subgroups of interest .
RESULTS	Most of the 435 participants were elderly ( mean age = 63.7 years ) , African-American ( 91 % ) , and read below the 9th-grade level ( 78 % ) .
RESULTS	Among the 420 subjects ( 97 % ) for whom CMG could be calculated , 138 ( 32.9 % ) had CMG < 0.20 during follow-up and were considered adherent .
RESULTS	Overall , adherence did not differ significantly across treatments : 31.2 % in usual care , 28.3 % with mailed refill reminders , 34.2 % with illustrated medication schedules , and 36.9 % with both interventions .
RESULTS	In post-hoc analyses , illustrated medication schedules led to significantly greater odds of adherence among patients who at baseline had more than eight medications ( OR = 2.2 ; 95 % CI , 1.21 to 4.04 ) or low self-efficacy for managing medications ( OR = 2.15 ; 95 % CI , 1.11 to 4.16 ) ; a trend was present among patients who reported non-adherence at baseline ( OR = 1.89 ; 95 % CI , 0.99 to 3.60 ) .
CONCLUSIONS	The interventions did not improve adherence overall .
CONCLUSIONS	Illustrated medication schedules may improve adherence among patients with low self-efficacy , polypharmacy , or baseline non-adherence , though this requires confirmation .

###10359887
BACKGROUND	Although inhaled corticosteroids are widely used for the treatment of inflammation in asthma , prospective , long-term , placebo-controlled trials characterizing their systemic safety with chronic use are lacking .
OBJECTIVE	This study was designed to prospectively evaluate the long-term safety of inhaled fluticasone propionate therapy .
METHODS	Fluticasone propionate powder , 500 microgram , or placebo was administered twice daily by means of the Diskhaler for 104 weeks to 64 adults with mild persistent asthma in a randomized , double-blind , parallel-group study .
METHODS	Primary safety variables were measured at baseline and every 6 months thereafter .
METHODS	Although evaluation of efficacy was not an objective of this study , pulmonary function testing was performed at monthly intervals .
RESULTS	Two years of treatment with fluticasone propionate had no significant effects on the skeletal system .
RESULTS	No clinically significant changes were observed in ophthalmic parameters ( glaucoma and posterior subcapsular cataracts ) .
RESULTS	Mean change from baseline in lumbar spine ( L1 to L4 ) bone density at week 104 was not significantly different between fluticasone propionate ( -0.006 + / - 0.008 g/cm2 ) and placebo ( -0.007 + / - 0.010 g/cm2 ) .
RESULTS	Markers of bone formation ( serum osteocalcin ) and resorption ( urinary N-telopeptide ) did not differ significantly between treatment groups .
RESULTS	The effects of fluticasone propionate treatment on the hypothalamic-pituitary-adrenal axis were minimal , with no alterations in morning plasma cortisol concentrations and minor but statistically significant decreases in poststimulation mean peak plasma cortisol concentrations ( P = .021 ) and 8-hour plasma cortisol area under the curve values ( P = .020 ) at week 104 .
RESULTS	Drug-related adverse events were primarily topical effects of inhaled corticosteroids .
RESULTS	Pulmonary function improved significantly during 2 years of fluticasone propionate treatment .
CONCLUSIONS	Fluticasone propionate powder , 500 microgram twice daily for up to 2 years , was efficacious and well tolerated , with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis , bone density , or ophthalmic parameters in adults with mild asthma .

###25103167
BACKGROUND	Although several interventions have shown reduced HIV incidence in clinical trials , the community-level effect of effective interventions on the epidemic when scaled up is unknown .
BACKGROUND	We investigated whether a multicomponent , multilevel social and behavioural prevention strategy could reduce HIV incidence , increase HIV testing , reduce HIV risk behaviour , and change social and behavioural norms .
METHODS	For this phase 3 cluster-randomised controlled trial , 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV ( intervention group ) or standard counselling and testing alone ( control group ) between January , 2001 , and December , 2011 .
METHODS	The intervention was designed to make testing more accessible in communities , engage communities through outreach , and provide support services after testing .
METHODS	Randomisation was done by a computer-generated code and was not masked .
METHODS	Data were collected at baseline ( n = 14 567 ) and after intervention ( n = 56.683 ) by cross-sectional random surveys of community residents aged 18-32 years .
METHODS	The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay .
METHODS	Thailand was excluded from incidence analyses because of low HIV prevalence .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT00203749 .
RESULTS	The estimated incidence of HIV in the intervention group was 1.52 % versus 1.81 % in the control group with an estimated reduction in HIV incidence of 13.9 % ( relative risk [ RR ] 0.86 , 95 % CI 0.73-1 .02 ; p = 0.082 ) .
RESULTS	HIV incidence was significantly reduced in women older than 24 years ( RR = 0.70 , 0.54-0 .90 ; p = 0.0085 ) , but not in other age or sex subgroups .
RESULTS	Community-based voluntary counselling and testing increased testing rates by 25 % overall ( 12-39 ; p = 0.0003 ) , by 45 % ( 25-69 ; p < 00001 ) in men and 15 % ( 3-28 ; p = 0.013 ) in women .
RESULTS	No overall effect on sexual risk behaviour was recorded .
RESULTS	Social norms regarding HIV testing were improved by 6 % ( 95 % CI 3-9 ) in communities in the intervention group .
CONCLUSIONS	These results are sufficiently robust , especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour , to recommend the Project Accept approach as an integral part of all interventions ( including treatment as prevention ) to reduce HIV transmission at the community level .
BACKGROUND	US National Institute of Mental Health , the Division of AIDS of the US National Institute of Allergy and Infectious Diseases , and the Office of AIDS Research of the US National Institutes of Health .

###21521884
OBJECTIVE	This prospective study evaluates the efficacy of using a single miniplate at the inferior border in the management of a displaced angle fracture .
METHODS	Case series with chart review .
METHODS	Pt .
METHODS	B.D. Sharma University of Health Sciences .
METHODS	Fifty-two patients with angle fracture of the mandible were evaluated .
METHODS	All fractures were displaced .
METHODS	The displacement of fracture was assessed on panoramic radiography by measuring the displacement of the inferior alveolar canal .
METHODS	Fractures with displacement greater than 2 mm were included in the study .
METHODS	Fixation with a 4-hole noncompression miniplate along the inferior border and 2 bicortical screws on each side of the fracture was done .
RESULTS	Among these 52 patients , 20 sustained isolated angle fracture , 2 sustained bilateral angle fracture , and 30 sustained angle fracture associated with contralateral parasymphysis or body fracture .
RESULTS	Five patients ( 9.5 % ) experienced complications .
RESULTS	All were considered minor and did not require hospitalization .
RESULTS	Two had a slight occlusal discrepancy requiring selective occlusal grinding , and 2 minor infections were managed by incision and drainage .
RESULTS	One patient suffered from paresis of the facial nerve that resolved itself after 3 months .
CONCLUSIONS	Based on this single study , at a single institution , we can conclude that outcomes are acceptable in our patients , but there is very limited ability to generalize the results to different practice settings .
CONCLUSIONS	Because of these limitations , a multicenter study with an appropriate comparison group is required to substantiate a more generalizable conclusion of efficacy of this single miniplate at inferior border .

###19394503
OBJECTIVE	To investigate the renoprotective effect of nicardipine in patients undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) in a prospective trial .
OBJECTIVE	Superior visualization of the increasingly performed RALRP requires pneumoperitoneum and extreme head-down tilt , both of which are associated with a decrease in postoperative renal function .
OBJECTIVE	Nicardipine causes preferential dilation of the renal arterioles and attenuates renal dysfunction after cardiac surgery .
METHODS	After we obtained institutional review board approval , we randomly treated 100 patients undergoing RALRP with a continuous infusion of nicardipine at a rate of 0.5 microg/kg/min ( nicardipine group , n = 50 ) or with normal saline ( control group , n = 50 ) during surgery .
METHODS	We measured the serum creatinine ( Cr ) level and estimated glomerular filtration rate ( eGFR ) 1 day before surgery and the first and third postoperative days ( POD 1 and 3 , respectively ) .
RESULTS	Patients ' characteristics and operative data were similar between groups .
RESULTS	The serum Cr was significantly higher and the eGFR was significantly lower in the control group at POD 1 .
RESULTS	The number of patients having renal insufficiency ( eGFR < 60 mL/min/1 .73 m ( 2 ) ) and abnormal serum creatinine level ( > 1.4 mg/dL ) was significantly greater in the control group ( 9 vs 1 , and 4 vs none , respectively ) at POD 1 .
CONCLUSIONS	Continuous infusion of low-dose nicardipine during RALRP seems to offset the deleterious effects of inevitable pneumoperitoneum and extreme head-down tilt on renal function in preserving the eGFR and attenuating the development of renal insufficiency in the immediate postoperative period .

###12225709
OBJECTIVE	We sought to conduct a randomized trial comparing late revascularization with conservative therapy in symptom-free patients after acute myocardial infarction ( AMI ) .
BACKGROUND	In the absence of ischemia , the benefits of reperfusion late after AMI remain controversial .
BACKGROUND	However , the possibility exists that an open infarct related artery benefits healing post AMI .
METHODS	Of 223 patients enrolled with Q-wave anterior AMI , 66 with isolated persistent occlusion of the left anterior descending coronary artery ( LAD ) were randomized to the following treatments : 1 ) medical therapy ( closed artery group ; n = 34 ) or 2 ) late intervention and stent to the LAD + medical therapy ( open artery group ; n = 32 ) .
METHODS	The study was powered to compare left ventricular ( LV ) end-systolic volume between the two groups 12 months post AMI .
RESULTS	Late intervention 26 + / - 18 days post AMI resulted in significantly greater LV end-systolic and end-diastolic volumes at 12 months than medical therapy alone ( 106.6 + / - 37.5 ml vs. 79.7 + / - 34.4 ml , p < 0.01 and 162.0 + / - 51.4 ml vs. 130.1 + / - 46.1 ml , p < 0.01 , respectively ) .
RESULTS	Exercise duration and peak workload significantly increased in both groups from 6 weeks to 12 months post AMI , although absolute values were greater in the open artery group .
RESULTS	Quality of life scores tended to deteriorate during this time interval in the closed artery patients but remained unchanged in the open artery patients .
RESULTS	Coronary angiography at 1 year documented a low incidence of intergroup cross-over ( spontaneous recanalization in 19 % and closure in 11 % ) .
CONCLUSIONS	In the present study , recanalization of occluded infarct-related arteries in symptom-free patients approximately 1 month post AMI had an adverse effect on remodeling but tended to increase exercise tolerance and improve quality of life .

###23422630
BACKGROUND	Triphala is a botanical preparation consisting of equal parts of three herbal fruits .
BACKGROUND	Much revered in Ayurveda , triphala has been proven to have antibacterial , antiviral , antifungal actions .
OBJECTIVE	The objective of this study was to investigate the effect of 6 % triphala in a mouthwash formulation on the salivary streptococci levels at the end of 48 h and 7 days , of twice a day usage , and to compare the same with 0.2 % chlorhexidine .
METHODS	Sixty undergraduate student volunteers aged between 18 and 25 years were randomly allocated into three study groups .
METHODS	( a ) 6 % triphala mouthwash , 15 ml twice a day ; ( b ) 0.2 % chlorhexidine mouthwash , 15 ml twice a day ( active control group ) ; ( c ) passive control group asked to rinse with plain water , twice a day .
METHODS	The oral streptococci colony forming units/ml ( CFUs/ml ) was assessed by inoculating blood agar with saliva samples at the end of 48 h and at 7 days .
RESULTS	The triphala group showed a 17 % and 44 % reduction , while the chlorhexidine group showed 16 % and 45 % reduction at the end of 48 h and 7 days ( P < 0.001 ) .
RESULTS	The reduction in CFUs/ml seen in triphala group closely paralleled that of chlorhexidine group .
CONCLUSIONS	Triphala has been used in Ayurveda from time immemorial and has many potential systemic benefits .
CONCLUSIONS	The promising results shown by Triphala call for further investigations of its antimicrobial effects against the numerous oral microorganisms .

###17174228
BACKGROUND	Recent data suggest that differences in response to therapy and survival exist between African Americans and Caucasians with heart failure .
BACKGROUND	Whether these differences exist in acute decompensated heart failure ( ADHF ) is uncertain .
RESULTS	We analyzed data from the OPTIME-CHF ( Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure ) study , a randomized trial of intravenous milrinone versus placebo in 949 patients hospitalized with ADHF .
RESULTS	We evaluated differences in clinical characteristics , outcomes , and response to milrinone therapy in African American patients compared with Caucasians .
RESULTS	The primary end point of OPTIME-CHF was days hospitalized for cardiovascular causes or death within 60 days of randomization .
RESULTS	Thirty-three percent ( n = 310 ) of patients were African American .
RESULTS	African American patients were younger ( 57 vs. 70 years , P < .0001 ) and more likely to have non-ischemic cardiomyopathy ( 74 % vs. 36 % , P < .0001 ) .
RESULTS	In unadjusted analysis , African American patients had a lower 60-day mortality ( 5 % vs. 12 % , P = .0004 ) and tended to have better overall clinical outcomes .
RESULTS	After adjustment for baseline differences , however , these differences were no longer significant .
RESULTS	We found no differential effect of milrinone therapy by race .
CONCLUSIONS	African American patients with acute decompensated heart failure present with a different clinical profile than Caucasian patients .
CONCLUSIONS	Although unadjusted clinical outcomes are better for African Americans presenting with ADHF , these differences diminished after adjustment for baseline characteristics .

###17595201
OBJECTIVE	We compared the radiological features and outcome of WHO defined severe pneumonia among HIV infected and exposed uninfected children randomised to receive penicillin or oral amoxicillin in Durban , South Africa .
METHODS	Of 425 children aged between 3 and 59 months with WHO defined severe pneumonia , 366 had anonymous HIV testing performed .
METHODS	Outcome was assessed by failure to improve at 48 h after enrolment or deterioration within 14 days .
METHODS	Chest radiographs were evaluated according to WHO defined radiological criteria for pneumonia and internationally standardised radiological criteria .
METHODS	Findings were stratified for HIV status .
RESULTS	82 ( 22.4 % ) children were HIV infected , 40 ( 10.9 % ) were HIV exposed and 244 ( 66.7 % ) were HIV uninfected .
RESULTS	The day 14 outcome in children < 12 months of age was significantly worse in HIV-1 infected than HIV uninfected children ( OR 2.8 ( 95 % CI 1.35 to 3.5 ) , p = 0.002 ) , while HIV-1 infected and uninfected children aged > or = 12 months had equivalent outcomes .
RESULTS	Parental penicillin and oral amoxicillin had equivalent response rates in all HIV groups .
RESULTS	According to the WHO radiological classification , children who failed WHO standard antimicrobial treatment had significantly higher `` other consolidates/infiltrates '' than `` endpoints for consolidation '' in the HIV infected group ( OR 5.45 ( 95 % CI 1.58 to 21.38 ) , p < 0.002 ) , while the reverse was true for HIV exposed uninfected children ( OR 4.13 ( 95 % CI 0.88 to 20.57 ) , p < 0.036 ) .
CONCLUSIONS	The WHO standard treatment guideline for severe pneumonia is inadequate for HIV-1 infected infants .
CONCLUSIONS	The increased prevalence of `` other consolidates/infiltrates '' among HIV-1 infected children who failed standard treatment supports the addition of co-trimoxazole to WHO standard treatment .

###24339418
OBJECTIVE	The myeloid-related proteins 8 and 14 ( MRP-8 / MRP-14 ) and neutrophil-derived S100A12 are biomarkers of inflammation .
OBJECTIVE	They can be used to determine the relapse risk in patients with juvenile idiopathic arthritis ( JIA ) after stopping antiinflammatory treatment .
OBJECTIVE	In this study , we tested the performance of different enzyme-linked immunosorbent assays ( ELISAs ) in order to validate systems available for routine use .
METHODS	MRP-8 / MRP-14 and S100A12 serum concentrations of 188 JIA patients in remission were analyzed .
METHODS	Commercially available test systems were compared to experimental ELISAs established in house .
METHODS	The ability of the assays to identify JIA patients at risk for relapse was analyzed .
RESULTS	For MRP-8 / MRP-14 , the PhiCal Calprotectin and Buhlmann MRP8/14 Calprotectin ELISAs revealed hazard ratios of 2.3 and 2.1 , respectively .
RESULTS	For S100A12 , the CircuLex S100A12/EN-RAGE ELISA revealed a hazard ratio of 3.1 .
RESULTS	The commercial assays allowed a JIA relapse prediction that was at least comparable to the experimental ELISAs .
CONCLUSIONS	For the prediction of JIA relapse after stopping medication , the biomarkers MRP-8 / MRP-14 and S100A12 can be determined by using assays that are available for routine use .
CONCLUSIONS	The tested commercial MRP-8 / MRP-14 and S100A12 ELISAs showed a performance comparable to well-established experimental ELISA protocols when assay-specific cutoffs for the indication of relapse prediction are thoroughly applied .

###9883209
OBJECTIVE	To determine correlations between residents ' scores on psychological inventories and their demographics and personal histories .
METHODS	The authors followed all family practice residents in South Carolina from July 1993 to January 1996 .
METHODS	They invited the residents to take a battery of psychological inventories every July and January during the study .
METHODS	The inventories included the Beck Depression Inventory ( BDI ) and the Profile of Mood States ( POMS ) .
METHODS	The participating residents also filled out personal and family history questionnaires at each test administration .
RESULTS	Of the 350 residents in family practice training during the study , 284 took the BDI at least once and 280 took the POMS at least once .
RESULTS	Cross-sectional data indicated that 3 % of those taking the BDI and 7 % of those taking the POMS showed significant depressive or mood-disturbance symptoms , levels similar to those found in previous studies .
RESULTS	Analyses found correlations between residents ' descriptions of poor physical or emotional health , unhappy childhoods , current high stress in training , or doubt about specialty choice and high scores on the two inventories .
RESULTS	No such correlation was found between high inventory scores and age , sex , race , duration of training , season of the year , exercise pattern , recent life events , income , or level of indebtedness .
CONCLUSIONS	Although the results of this study may not be generalizable , medical educators and those who counsel physicians during graduate training may want to take note of the correlations between certain answers to questions about personal history and higher levels of depression and mood disturbance as measured by psychological inventories .

###22928872
BACKGROUND	Chronic kidney disease is an important public health threat .
BACKGROUND	Such patients present high morbidity and mortality due to cardiovascular disease , with low quality of life and survival , and also high expenditure resulting from the treatment .
BACKGROUND	Arterial hypertension is both a cause and a complication of kidney disease ; also , arterial hypertension is a risk factor for cardiovascular disease among patients with kidney diseases .
BACKGROUND	There is some evidence that exercise interventions may be beneficial to chronic kidney disease patients , but previous studies included only end-stage patients , i.e. those undergoing dialysis .
BACKGROUND	This study aims to evaluate the effect of exercise on kidney function , quality of life and other risk factors for cardiovascular disease among non-diabetic chronic hypertensive kidney disease patients who are not undergoing dialysis .
METHODS	The participants will be located through screening hypertensive patients attended within the public healthcare network in Pelotas , a city in south of Brazil .
METHODS	Eligible individuals will be those with glomerular filtration rate between 15 and 59ml/min x 1.73 m ( 2 ) .
METHODS	The randomization will be done in fixed-size blocks of six individuals such that 75 participants will be allocated to each group .
METHODS	At baseline , information on demographic , socioeconomic , behavioral , anthropometric , blood pressure and quality-of-life variables will be collected , and laboratory tests will be performed .
METHODS	The intervention will consist of three weekly physical exercise sessions lasting 60-75minutes each , with a total duration of 16weeks .
METHODS	The outcomes will be the kidney function progression rate , quality of life , blood pressure , lipid profile , hemoglobin level , ultrasensitive C-reactive protein level , and ankle-arm index .
METHODS	The patients in both groups ( intervention and control ) will be reassessed and compared partway through the study ( 8th week ) , at the end of the intervention ( 16th week ) and in the 8th week after the end of the intervention .
CONCLUSIONS	There is still a scarcity of data relating to the effect of physical exercise among the most numerous group of individuals with kidney disease , i.e. patients undergoing conservative treatment .
CONCLUSIONS	In particular , there is a lack of randomized controlled studies .
CONCLUSIONS	This study will help fill this gap .

###22116959
OBJECTIVE	There is evidence that multifocal visual evoked potentials ( VEPs ) can be used as an objective tool to detect visual field loss .
OBJECTIVE	The aim of this study was to correlate multifocal VEP amplitudes with standard perimetry data and retinal nerve fibre layer ( RNFL ) thickness .
METHODS	Multifocal VEP recordings were performed with a four-channel electrode array using 58 stimulus fields ( pattern reversal dartboard ) .
METHODS	For each field , the recording from the channel with maximal signal-to-noise ratio ( SNR ) was retained , resulting in an SNR optimised virtual recording .
METHODS	Correlation with RNFL thickness , measured with spectral domain optical coherence tomography and with standard perimetry , was performed for nerve fibre bundle related areas .
RESULTS	The mean amplitudes in nerve fibre related areas were smaller in glaucoma patients than in normal subjects .
RESULTS	The differences between both groups were most significant in mid-peripheral areas .
RESULTS	Amplitudes in these areas were significantly correlated with corresponding RNFL thickness ( Spearman R = 0.76 ) and with standard perimetry ( R = 0.71 ) .
CONCLUSIONS	The multifocal VEP amplitude was correlated with perimetric visual field data and the RNFL thickness of the corresponding regions .
CONCLUSIONS	This method of SNR optimisation is useful for extracting data from recordings and may be appropriate for objective assessment of visual function at different locations .
BACKGROUND	This study has been registered at http://www.clinicaltrials.gov ( NCT00494923 ) .

###24798072
OBJECTIVE	To analyze the impact of the eSET followed by single-embryo cryotransfer versus double embryo transfer in older women ( < 38 years ) without taking into account embryo quality .
METHODS	This is a prospective randomised clinical trial performed on 194 couples attempting a first IVF cycle in a Public Hospital in Spain .
METHODS	The women in Group 1 received eSET plus a single-embryo cryotransfer , and those in Group 2 received a double embryo transfer ( DET ) .
RESULTS	In the intention-to-treat analysis , the cumulative live birth delivery rate in the eSET group was similar to the results obtained for the DET group ( 45.2 % vs. 41.8 % ; p = 0.60 ) .
RESULTS	The rate of multiple gestation was significantly lower in the eSET group than in the DET group ( 0 % vs. 26.4 % ; p < 0.05 ) .
RESULTS	The findings obtained in the per-protocol analysis were similar to those obtained in the intention-to-treat analysis .
RESULTS	The per-protocol analysis revealed no significant differences in the rate of implantation ( 29.8 % in eSET vs. 29.7 % in DET ; p = 0.98 ) , in cumulative pregnancy rates per transfer ( 49.1 % in eSET vs. 46.9 % in DET ; p = 0.80 ) or in the cumulative live birth delivery rate ( 38.6 % in eSET vs. 42.2 % in DET ; p = 0.69 ) .
RESULTS	In the cycles with eSET , there were no twin pregnancies ( 0 % in eSET vs. 27.6 in DET ; p < 0.05 ) .
CONCLUSIONS	For women aged under 38 years with good prognosis , without taking embryo quality as a criterion for inclusion , an eSET policy can be applied , achieving acceptable cumulative clinical pregnancy rates and birth rates .

###15625255
OBJECTIVE	To compare patient controlled inhalational induction ( PCI ) with the most commonly used sevoflurane induction technique , vital capacity inhalational induction ( VCI ) .
METHODS	Following approval of the Research Ethics Board , 124 outpatients undergoing knee arthroscopy were randomly assigned to receive either PCI or VCI sevoflurane followed by laryngeal mask airway ( LMA ) insertion and sevoflurane maintenance .
METHODS	In the PCI group , the circle circuit was not primed .
METHODS	The patients were asked to hold the facemask themselves and breathe normally with sevoflurane 8 % in oxygen at a flow rate of 4 L x min ( -1 ) .
METHODS	In the VCI group , the circle circuit was primed and patients were asked to take vital capacity breaths with sevoflurane 8 % at an oxygen flow rate of 8 L x min ( -1 ) .
METHODS	The LMA was inserted as soon as the patient 's jaw was relaxed .
METHODS	Time from induction to LMA insertion was recorded and insertion conditions rated .
METHODS	The amount of sevoflurane used for LMA insertion was calculated .
METHODS	Vital signs were monitored at one-minute intervals until ten minutes after LMA insertion .
RESULTS	Demographic data were comparable .
RESULTS	There were no differences with respect to LMA insertion time ( PCI - 3.4 min vs VCI - 3.3 min ) , laryngospasm ( PCI - 7 % vs VCI - 5 % ) , mean arterial pressure , heart rate , SaO ( 2 ) as well as patient 's overall satisfaction .
CONCLUSIONS	PCI was comparable to VCI in sevoflurane induction with respect to the speed of induction , side effects during induction and patient satisfaction .
CONCLUSIONS	However , PCI requires no special training and is widely applicable to all patient populations .

###14749753
OBJECTIVE	We investigated whether ingestion of polyphenols from fruit juices or a fruit-vegetable-concentrate affects lymphocyte proliferation and apoptosis in human immunodeficiency virus ( HIV ) - seropositive ( HIV ( + ) ) and HIV-seronegative ( HIV ( - ) ) subjects .
METHODS	Randomized , prospective pilot intervention study .
METHODS	University of Bonn , Department of General Internal Medicine .
METHODS	A total of 23 HIV ( + ) subjects from the HIV outpatient clinic , 18 HIV ( - ) controls .
METHODS	Subjects ingested either 1 l of fruit juice or 30 ml of fruit-vegetable-concentrate daily for 16 weeks in addition to their regular diet .
METHODS	Lymphocyte proliferation and apoptosis were investigated in peripheral blood mononuclear cells at baseline , during 16-weeks of intervention , and after a 6-week washout .
METHODS	Proliferation was assessed by ( 3 ) H-thymidine incorporation and apoptosis by nuclear content as measured by flow cytometry .
RESULTS	Supplementation of fruit juices increased phytohemagglutinin-induced lymphocyte proliferation ( mitotic index ) in HIV ( + ) patients from 18 + / -16 to 40 + / -34 ( P = 0.004 ) and in healthy controls from 27 + / -16 to 51 + / -21 ( P = 0.016 ) .
RESULTS	Apoptosis was not affected in HIV ( + ) patients , but rose in healthy controls from 9 + / -10 to 34 + / -11 ( apoptotic index ; P = 0.001 ) .
RESULTS	Intervention with concentrate did not significantly alter proliferation and apoptosis in HIV ( + ) and HIV ( - ) subjects .
CONCLUSIONS	Even though apoptosis did not change in HIV ( + ) subjects , ingestion of polyphenol-rich fruit juices might be favorable to HIV ( + ) patients due to enhanced proliferation , which could restore disturbances in T-cell homeostasis .
CONCLUSIONS	In healthy controls , increased lymphocyte proliferation during juice consumption was counterbalanced by increased apoptosis .

###11106122
BACKGROUND	This study was performed to evaluate the pharmacokinetics , bioequivalence , and feasibility of a combined oral formulation of 5-flurouracil ( 5-FU ) and eniluracil ( Glaxo Wellcome Inc. , Research Triangle Park , North Carolina ) , an inactivator of dihydropyrimidine dehydrogenase ( DPD ) .
BACKGROUND	The rationale for developing a combined eniluracil/5-FU formulation oral dosing form is to simplify treatment with these agents , which has been performed using separate dosing forms , and decrease the probability of severe toxicity and/or suboptimal therapeutic results caused by inadvertently high or conversely insufficient 5-FU dosing .
METHODS	The trial was a randomized , three-way crossover bioequivalence study of three oral dosing forms of eniluracil/5-FU tablets in adults with solid malignancies .
METHODS	Each period consisted of two days of treatment and a five - to seven-day washout phase .
METHODS	Eniluracil at a dose of 20 mg , which results in maximal DPD inactivation , was administered twice daily on the first day and in the evening on the second day of each of the three treatments .
METHODS	On the morning of the second day , all patients received a total eniluracil dose of 20 mg orally and a total 5-FU dose of 2 mg orally as either separate tablets ( treatment A ) or combined eniluracil/5-FU tablets in two different strengths ( 2 tablets of eniluracil/5-FU at a strength ( mg/mg ) of 10/1 ( treatment B ) or 8 tablets at a strength of 2.5 / 0.25 ( treatment C ) ) .
METHODS	The pharmacokinetics of plasma 5-FU , eniluracil , and uracil , and the urinary excretion of eniluracil , 5-FU , uracil , and alpha-fluoro-beta-alanine ( FBAL ) , were studied .
METHODS	To determine the bioequivalence of the combined eniluracil/5-FU dosing forms compared to the separate tablets , an analysis of variance on pharmacokinetic parameters reflecting eniluracil and 5-FU exposure was performed .
RESULTS	Thirty-nine patients with advanced solid malignancies had complete pharmacokinetic studies performed during treatments A , B , and C.
RESULTS	The pharmacokinetics of eniluracil and 5-FU were similar among the three types of treatment .
RESULTS	Both strengths of the combined eniluracil/5-FU dosing form and the separate dosing forms were bioequivalent .
RESULTS	Mean values for terminal half-life , systemic clearance , and apparent volume of distribution for oral 5-FU during treatments A/B/C were 5.5 / 5.6 / 5.6 hours , 6.6 / 6.6 / 6.5 liters/hour , and 50.7 / 51.5 / 50.0 liters , respectively .
RESULTS	The intersubject coefficient of variation for pharmacokinetic variables reflecting 5-FU exposure and clearance in treatments ranged from 23 % to 33 % .
RESULTS	The urinary excretion of unchanged 5-FU over 24 hours following treatments A , B , and C averaged 52.2 % , 56.1 % , and 50.8 ' % , of the administered dose of 5-FU , respectively .
RESULTS	Parameters reflecting DPD inhibition , including plasma uracil and urinary FBAL excretion following treatments A , B , and C were similar .
RESULTS	Toxicity was generally mild and similar following all three types of treatments .
CONCLUSIONS	The pharmacokinetics of 5-FU and eniluracil were similar and met bioequivalence criteria following treatment with the separate oral formulations of 5-FU and eniluracil and two strengths of the combined formulation .
CONCLUSIONS	The availability of a combined eniluracil/5-FU oral dosing form will likely simplify dosing and decrease the probability of severe toxicity or suboptimal therapeutic results caused by an inadvertent 5-FU overdose or insufficient 5-FU dosing in the case of separate oral formulations , thereby enhancing the overall feasibility and 0therapeutic index of oral 5-FU therapy .

###19223890
OBJECTIVE	Data are scarce on the head-to-head efficacy of terlipressin and octreotide as an adjuvant therapy to endoscopic management of variceal bleed .
OBJECTIVE	The aim of this study was to compare the efficacy and safety of terlipressin with octreotide as an adjuvant therapy to endoscopic variceal band ligation in patients with esophageal variceal bleeding .
METHODS	Cirrhotic patients with esophageal variceal bleed were randomized on admission to receive terlipressin ( group A ) or octreotide ( group B ) along with the placebo in the other arm in a double-blind fashion .
METHODS	The two groups were compared for efficacy , safety , overall survival , and length of hospital stay .
METHODS	`` Control of variceal bleed '' was the measure of efficacy of terlipressin and octreotide .
METHODS	Factors predicting length of stay were also assessed .
RESULTS	A total of 324 patients were enrolled ; 163 in the terlipressin group ( group A ) and 161 in the octreotide group ( group B ) .
RESULTS	The baseline characteristics of the two groups were comparable for age , gender , etiology of cirrhosis , hemoglobin at presentation , and Child-Pugh class , except that active bleed was seen during upper gastrointestinal endoscopy at the time of enrollment in 26 ( 16 % ) and 41 ( 25.5 % ) patients in groups A and B , respectively ( P = 0.034 ) .
RESULTS	Overall sixteen patients died ( three failure to control bleed and thirteen from causes other than variceal bleed ) ; nine in group A ( 5.5 % ) and seven ( 4.3 % ) in group B ( P = 0.626 ) .
RESULTS	In the intention to treat analysis , `` control of variceal bleed '' was noted in 305 patients ( 94.13 % ) ; 151 ( 92.63 % ) patients in group A and 154 ( 95.6 % ) patients in group B ( confidence interval : 0.219-1 .492 ) .
RESULTS	Packed cell transfusions in group A were 3.7 + / -2.3 units , whereas in group B there were 3.9 + / -2.5 units ( P = 0.273 ) .
RESULTS	Length of hospital stay in groups A and B was 108.40 + / -34.81 and 126.39 + / -47.45 h , respectively ( P < or = 0.001 ) .
RESULTS	No cardiovascular side effects were observed in either group .
RESULTS	High pulse , low hemoglobin , prothrombin time , blood in nasogastric aspirate , and portosystemic encephalopathy ( PSE ) were predictors of prolonged hospital stay .
CONCLUSIONS	The efficacy of terlipressin was not inferior to octreotide as an adjuvant therapy for the control of esophageal variceal bleed and in-hospital survival .
CONCLUSIONS	The length of hospital stay in the terlipressin group was significantly shorter but not of any clinical importance .
CONCLUSIONS	The predictors of prolonged hospital stay were low hemoglobin , high pulse , prolonged prothrombin time , blood at nasogastric aspirate , and PSE .

###17306648
OBJECTIVE	This study was undertaken to determine whether insulin resistance associated with combination hormone replacement therapy ( HRT ) is mediated by changes in serum markers of inflammation or in serum adipocyte hormones .
METHODS	Forty-five postmenopausal women , aged 55 + / - 7 years , were examined from a randomized , double-blind placebo-controlled trial evaluating the effect of HRT on insulin-stimulated glucose disposal and body composition .
METHODS	Volunteers were randomly assigned to conjugated estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg vs placebo for 1 year .
METHODS	At baseline and at 1 year , body composition was assessed by dual photon x-ray absorptiometry scans ; body fat distribution was measured by computed tomographic scans at the L4/L5 vertebral disk space ; insulin sensitivity was measured by euglycemic hyperinsulinemic clamp ; interleukin-6 ( IL-6 ) , leptin , and adiponectin were measured by enzyme-linked immunosorbent assay ; and c-reactive protein ( CRP ) was measured by radioimmunoassay .
RESULTS	HRT increased CRP by 121 % compared with a 32 % increase with placebo ( P = .03 ) ; HRT decreased glucose disposal by 17 % compared with no change with placebo ( P = .04 ) as reported previously .
RESULTS	HRT did not affect body composition , body fat distribution , IL-6 , leptin , or adiponectin .
RESULTS	The increase in CRP did not correlate with the decrease in glucose disposal in the HRT group ( R = 0.11 , P = .65 ) .
CONCLUSIONS	Treatment with HRT for one year increases CRP , but does not alter IL-6 , adiponectin , or leptin .
CONCLUSIONS	The change in CRP was not , however , related to the decrease in glucose disposal with HRT treatment .

###21386706
OBJECTIVE	Ambulatory blood pressure monitoring ( ABPM ) has greater predictive value than office blood pressure ( BP ) with respect to hypertension-related target-organ damage and morbidity .
OBJECTIVE	ABPM in a subset of 80 patients from the Exforge Target Achievement trial ( N = 728 ) was used to compare the efficacy of intensive-treatment and moderate-treatment regimens of amlodipine/valsartan , and to determine whether treatment differences could be better assessed with ABPM than with office or home BP .
OBJECTIVE	Home BP was measured on the morning of clinic visits to minimize differences that timing might have on home versus office BP measures .
METHODS	A 12-week randomized , double-blind study in which hypertensive patients earlier uncontrolled ( mean sitting systolic BP150 and < 200 mmHg ) on angiotensin receptor blocker monotherapy ( other than valsartan ) after 28 days or more ( N = 728 ) were randomized to amlodipine/valsartan treatment [ 10/320 mg ( intensive ) or 5/160 mg ( moderate ) ] .
METHODS	Treatment-naive patients ( in previous 28 days ) or patients who failed on a nonangiotensin receptor blocker agent underwent a 28-day run-in period with a 20-mg or 40-mg dose of olmesartan , respectively .
RESULTS	Significantly greater 24-h ABP reductions from baseline to week 4 ( primary time point ) were observed with intensive versus moderate treatment ( least-square mean systolic/diastolic BP reduction of -16.2 / -10.1 vs. -9.5 / -6.5 mmHg ; P = 0.0024 / P = 0.010 for least-square mean difference ) .
RESULTS	Similarly , a significantly greater proportion of patients receiving an intensive treatment achieved ambulatory BP goal ( < 130/80 mmHg ) at week 4 than did those receiving a moderate treatment ( P = 0.040 ) .
RESULTS	Treatment-group differences did not reach statistical significance for these end points when measured by office and home BP .
CONCLUSIONS	In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan , our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings , although measurement of home BP as a single recording was a limitation of our trial .

###16448799
OBJECTIVE	The aim of this study was to compare the effect of nursing intervention to the effect of problem solving training on the level of postpartum depressive symptom .
METHODS	We utilized a pretest-posttest mutual controlled semi experimental model for this study .
METHODS	The study consisted of 62 women ( 30 in care group and 32 in training group ) , all of who were at risk for postpartum depression , but without major depressive symptoms .
METHODS	These women were not undergoing pharmacologic or psychotherapeutic treatment , were all literate and consented to join the study in Erzurum , Turkey .
METHODS	Participants ( N = 62 ) , recruited over a 9 month , were randomly assigned to one of two groups .
METHODS	Women in care group ( average age = 21 , 33.3 % primaparus ) were given nursing care for her depressive symptoms .
METHODS	Women in training group ( average age = 25 , 33.9 % primaparus ) were taught problem solving skills .
RESULTS	Depressive symptoms were assessed before and after nursing interventions .
RESULTS	We found that nursing care was effective women for with depressive symptoms ( McNemar test , p < 0.001 ) , and problem-solving training was also effective ( McNemar test , p < 0.05 ) .
RESULTS	When the effectiveness of nursing care and the problem solving education was compared utilizing the BDI , it was found out that the nursing care was more effective than education alone ( t = 4.529 , p < 0.05 ) .
CONCLUSIONS	Results from this study suggest that nursing care and problem solving training may be use confidently in the primary care setting by nurses for women with postpartum depressive symptoms .
CONCLUSIONS	Nurses play on important role in its detection and can reduce depressive symptoms .
CONCLUSIONS	Public health nurses are equipped with care paths addressing specific health needs of depressed women in the primary care setting .
CONCLUSIONS	Our finding indicate that these two programs of study can converge with meaningful results , and perhaps future research could address these points in a theoretical framework .

###12734908
OBJECTIVE	Fibromyalgia ( FM ) is associated with the sleep phenomenon of alpha intrusion , and with low growth hormone secretion .
OBJECTIVE	Sodium oxybate has been shown to increase both slow-wave sleep and growth hormone levels .
OBJECTIVE	This double blind , randomized , placebo controlled crossover trial was conducted to evaluate the effects of sodium oxybate on the subjective symptoms of pain , fatigue , and sleep quality and the objective polysomnographic ( PSG ) sleep variables of alpha intrusion , slow-wave ( stage 3/4 ) sleep , and sleep efficiency in patients with FM .
METHODS	Patients received either 6.0 g/day sodium oxybate or placebo for 1 month , with an intervening 2 week washout period .
METHODS	Efficacy measures included PSG evaluations , tender point index ( TPI ) , and subjective measurements from daily diary entries .
METHODS	Safety measures included clinical laboratory values , vital signs , and adverse events .
RESULTS	Twenty-four female patients were included in the study ; 18 completed the trial .
RESULTS	TPI was decreased from baseline by 8.5 , compared with an increase of 0.4 for placebo ( p = 0.0079 ) .
RESULTS	Six of the 7 pain/fatigue scores ( overall pain , pain at rest , pain during movement , end of day fatigue , overall fatigue , and morning fatigue ) were relieved by 29 % to 33 % with sodium oxybate , compared with 6 % to 10 % relief with placebo ( p < 0.005 ) .
RESULTS	Alpha intrusion , sleep latency , and rapid-eye-movement sleep were significantly decreased , while slow-wave ( stage 3/4 ) sleep was significantly increased , compared with placebo ( p < 0.005 ) .
RESULTS	Two of the 5 subjective sleep related variables were significantly different from placebo : morning alertness ( improved by 18 % with sodium oxybate , compared with 2 % for placebo ; p = 0.0033 ) and quality of sleep ( improved by 33 % and 10 % , respectively ; p = 0.0003 ) .
CONCLUSIONS	Sodium oxybate effectively reduced the symptoms of pain and fatigue in patients with FM , and dramatically reduced the sleep abnormalities ( alpha intrusion and decreased slow-wave sleep ) associated with the nonrestorative sleep characteristic of this disorder .

###23880908
BACKGROUND	Little is known about the effects of small doses of dexamethasone used for the prophylaxis of postoperative nausea and vomiting on the innate host response .
OBJECTIVE	We studied the influence of dexamethasone 4mg on the perioperative plasma concentrations of interleukins after laparoscopic cholecystectomy .
OBJECTIVE	We hypothesised that there would be differences in pro-inflammatory interleukin concentrations in patients who received dexamethasone .
METHODS	A randomised controlled study .
METHODS	University hospital .
METHODS	Forty-six patients undergoing laparoscopic cholecystectomy under total intravenous anaesthesia were allocated randomly into one of two study groups ; 42 patients completed the study .
METHODS	Patients in group 1 ( dexamethasone , n = 22 ) received dexamethasone 4mg and group 2 ( n = 20 ) acted as controls .
METHODS	Plasma levels of tumour necrosis factor alpha and interleukins 1 , 6 , 8 , 10 and 13 were measured before anaesthesia , before surgery and 2 and 24h after surgery .
METHODS	The frequency and number of episodes of postoperative nausea and vomiting were recorded .
RESULTS	Areas under the curve of the percentage variation of interleukins 6 and 8 were significantly lower in the dexamethasone group .
RESULTS	There were no significant differences between groups in the areas under the curve for tumour necrosis factor alpha and interleukins 1 , 10 and 13 .
RESULTS	The greatest variation in interleukin concentrations was 2h postoperatively , when the concentration of interleukin 6 was greater in the control group , whereas the concentration of interleukin 10 was higher in the dexamethasone group .
RESULTS	Twenty-four hours after surgery , only the concentration of interleukin 6 remained significantly increased in both groups ( P = 0.001 and P = 0.002 , respectively ) .
RESULTS	There were no significant differences between groups in respect of postoperative nausea and vomiting .
CONCLUSIONS	Prophylactic dexamethasone given before laparoscopic cholecystectomy produced a significant decrease in concentrations of interleukins 6 and 8 .
CONCLUSIONS	Further studies are needed to investigate the clinical implications of these findings .

###20157652
OBJECTIVE	to evaluate the effects of three luting resins and roughening of the dentinal walls on the long-term retention of tapered titanium dowels .
METHODS	ninety-six single-rooted teeth were endodontically treated .
METHODS	All root specimens were divided into three groups ( n = 32 ) .
METHODS	Dowel spaces were then prepared with ISO 90 drills 10 mm deep .
METHODS	Corresponding prefabricated tapered titanium dowels were air abraded and luted with Panavia 21 ( P21 ) , Super Bond C&B ( SB ) or with Chemiace II ( CH ) according to the manufacturers ' instructions .
METHODS	In the subgroups of each luting agent , the dentinal walls were either left in their original state as prepared by the drills ( n = 16 ) , or roughened with a handheld diamondcoated ISO 90 cutting instrument ( n = 16 ) .
METHODS	The bonded specimens were stored in water at 37C for 3 days ( n = 8 ) or 150 days with simulated aging conditions of 37,500 thermal cycles ( 5C/55C ) and 300,000 mechanical loading cycles with 30 N ( n = 8 ) .
METHODS	Dowel retention in N was measured using a universal testing machine with a crosshead speed of 2 mm/min .
METHODS	Statistical analysis was performed with ANOVAs followed by Scheff post-hoc tests .
RESULTS	the dowel retention with P21 and SB was significantly higher than that of CH ( p 0.05 ) .
RESULTS	Roughening the dentinal walls significantly increased the retention for all cements ( p 0.01 ) .
RESULTS	Storage for 150 days with thermal cycling and mechanical loading caused a significant decrease in dowel retention ( p 0.05 ) .
CONCLUSIONS	P21 and SB luting resins provided a durable retention of prefabricated titanium dowels in root canals , especially for root canals with roughened dentinal walls , as the combined result of sliding friction , micromechanical interlocking and adhesive dentin bonding .

###10027430
OBJECTIVE	The improved lung deposition of hydrofluoroalkane-134a beclomethasone dipropionate ( HFA-BDP ) extrafine aerosol compared with chlorofluorocarbon beclomethasone dipropionate ( CFC-BDP ) suggests that lower doses of HFA-BDP may be required to provide equivalent asthma control .
OBJECTIVE	The present study was undertaken to test this hypothesis .
METHODS	A 10 - to 12-day run-in period confirmed that patients met established criteria of at least moderate asthma and the asthma was inadequately controlled by current therapy ( inhaled beta-agonist and CFC-BDP [ < or = 400 microg/d ] ) .
METHODS	A short course of oral prednisone , 30 mg/d for 7 to 12 days , was followed to establish the patients were steroid responsive and to provide an `` in-study '' baseline of `` optimal '' asthma control .
METHODS	A total of 347 patients were then randomized to HFA-BDP 400 microg/d , CFC-BDP 800 microg/d , or HFA-placebo for 12 weeks .
RESULTS	Morning peak expiratory flow ( AM PEF ) measurements showed that HFA-BDP 400 microg/d achieved equivalent control of asthma to CFC-BDP 800 microg/d at all time intervals after oral steroid treatment .
RESULTS	All other efficacy variables supported the AM PEF results and both active treatments were more effective than placebo .
RESULTS	The safety profile of HFA-BDP compared favorably with that of CFC-BDP with no unexpected adverse events reported .
CONCLUSIONS	These findings demonstrate that HFA-BDP provides equivalent control of moderate or moderately severe asthma as CFC-BDP in the population studied , but at half the total daily dose .

###18698359
BACKGROUND	Apical Membrane Antigen 1 ( AMA1 ) , a polymorphic merozoite surface protein , is a leading blood-stage malaria vaccine candidate .
BACKGROUND	This is the first reported use in humans of an investigational vaccine , AMA1-C1 / Alhydrogel , with the novel adjuvant CPG 7909 .
METHODS	A phase 1 trial was conducted at the University of Rochester with 75 malaria-naive volunteers to assess the safety and immunogenicity of the AMA1-C1 / Alhydrogel + CPG 7909 malaria vaccine .
METHODS	Participants were sequentially enrolled and randomized within dose escalating cohorts to receive three vaccinations on days 0 , 28 and 56 of either 20 microg of AMA1-C1 / Alhydrogel +564 microg CPG 7909 ( n = 15 ) , 80 microg of AMA1-C1 / Alhydrogel ( n = 30 ) , or 80 microg of AMA1-C1 / Alhydrogel +564 microg CPG 7909 ( n = 30 ) .
RESULTS	Local and systemic adverse events were significantly more likely to be of higher severity with the addition of CPG 7909 .
RESULTS	Anti-AMA1 immunoglobulin G ( IgG ) were detected by enzyme-linked immunosorbent assay ( ELISA ) , and the immune sera of volunteers that received 20 microg or 80 microg of AMA1-C1 / Alhydrogel + CPG 7909 had up to 14 fold significant increases in anti-AMA1 antibody concentration compared to 80 microg of AMA1-C1 / Alhydrogel alone .
RESULTS	The addition of CPG 7909 to the AMA1-C1 / Alhydrogel vaccine in humans also elicited AMA1 specific immune IgG that significantly and dramatically increased the in vitro growth inhibition of homologous parasites to levels as high as 96 % inhibition .
CONCLUSIONS	The safety profile of the AMA1-C1 / Alhydrogel + CPG 7909 malaria vaccine is acceptable , given the significant increase in immunogenicity observed .
CONCLUSIONS	Further clinical development is ongoing .
BACKGROUND	ClinicalTrials.gov NCT00344539 .

###17407035
BACKGROUND	Pneumococcal conjugate vaccines prevent invasive and noninvasive disease due to infection with vaccine serotypes .
BACKGROUND	Pneumococcal conjugate vaccines also prevent nasopharyngeal acquisition of vaccine serotypes , although the mechanism is incompletely understood .
METHODS	An efficacy trial of a 7-valent pneumococcal conjugate vaccine was conducted on the Navajo and White Mountain Apache reservations , located in the Southwestern United States ; group C meningococcal conjugate vaccine was the control vaccine .
METHODS	Infants were randomized to receive 7-valent pneumococcal conjugate vaccine or group C meningococcal conjugate vaccine at 2 , 4 , 6 , and 12 months of age .
METHODS	Immunogenicity and nasopharyngeal colonization studies were nested in the efficacy trial .
METHODS	We analyzed the correlation between serotype-specific serum IgG concentration at 7 and 13 months of age and nasopharyngeal acquisition of disease at 12 and 18 months of age , respectively .
METHODS	We adjusted for potential confounders using multivariate logistic regression .
RESULTS	Among 203 subjects , we observed 60 acquisitions of vaccine-type pneumococci , including 19 acquisitions of serotype 19F ( 31.7 % ) , and 17 acquisitions of serotype 23F ( 28.3 % ) .
RESULTS	Among recipients of 7-valent pneumococcal conjugate vaccine , increased serotype-specific serum IgG was associated with a reduction in nasopharyngeal acquisition of serotype 23F ( relative risk , 0.53 ; 95 % confidence interval , 0.31-0 .93 ) but was not associated with a reduction in acquisition of serotype 19F ( relative risk , 1.07 ; 95 % confidence interval , 0.57-2 .03 ) .
RESULTS	Among group C meningococcal conjugate vaccine recipients , serotype-specific serum IgG was not associated with a reduction in nasopharyngeal acquisition for either serotype .
CONCLUSIONS	An increase in serum antibody concentration was associated with reduced acquisition of serotype 23F pneumococcus ( but not with reduced acquisition of serotype 19F pneumococcus ) among recipients of 7-valent pneumococcal conjugate vaccine .
CONCLUSIONS	Differences in antibody concentration , in the functional characteristics of antibody , or in antibody kinetics during infancy may account for differences in carriage protection .

###22585883
OBJECTIVE	Poor blood pressure control is common in the United States .
OBJECTIVE	We conducted a study to determine whether health coaching with home titration of antihypertensive medications can improve blood pressure control compared with health coaching alone in a low-income , predominantly minority population .
METHODS	We randomized 237 patients with poorly controlled hypertension at a primary care clinic to receive either home blood pressure monitoring , weekly health coaching , and home titration of blood pressure medications if blood pressures were elevated ( n = 129 ) vs home blood pressure monitoring and health coaching but no home titration ( n = 108 ) .
METHODS	The primary outcome was change in systolic blood pressure from baseline to 6 months .
RESULTS	Both the home-titration arm and the no-home-titration arm had a reduction in systolic blood pressure , with no significant difference between them .
RESULTS	When both arms were combined and analyzed as a before-after study , there was a mean decrease in systolic blood pressure of 21.8 mm Hg ( P < .001 ) as well as a decrease in the number of primary care visits from 3.5 in the 6 months before the study to 2.6 during the 6-month study period ( P < .001 ) and 2.4 in the 6 months after the study ( P < .001 ) .
RESULTS	The more coaching encounters patients had , the greater their reduction in blood pressure .
CONCLUSIONS	Blood pressure control in a low-income , minority population can be improved by teaching patients to monitor their blood pressure at home and having nonprofessional health coaches assist patients , in particular , by counseling them on medication adherence .
CONCLUSIONS	The improved blood pressure control can be achieved while reducing the time spent by physicians .

###25713429
OBJECTIVE	Survivors of cervical cancer experience quality-of-life ( QOL ) disruptions that persist years after treatment .
OBJECTIVE	This study examines the effect of a psychosocial telephone counseling ( PTC ) intervention on QOL domains and associations with biomarkers .
METHODS	We conducted a randomized clinical trial in survivors of cervical cancer , who were 9 and less than 30 months from diagnosis ( n = 204 ) , to compare PTC to usual care ( UC ) .
METHODS	PTC included five weekly sessions and a 1-month booster .
METHODS	Patient-reported outcomes ( PROs ) and biospecimens were collected at baseline and 4 and 9 months after enrollment .
METHODS	Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures .
RESULTS	Participant mean age was 43 years ; 40 % of women were Hispanic , and 51 % were non-Hispanic white .
RESULTS	Adjusting for age and baseline scores , participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants ( all P < .05 ) ; significant differences in gynecologic and cancer-specific concerns ( P < .05 ) were sustained at 9 months .
RESULTS	Longitudinal change in overall QOL and anxiety did not reach statistical significance .
RESULTS	Participants with decreasing interleukin ( IL ) -4 , IL-5 , IL-10 , and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels .
CONCLUSIONS	This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer .
CONCLUSIONS	The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship .

###21862955
BACKGROUND	The mammalian target of rapamycin inhibitor sirolimus has been associated with an increased incidence of wound-healing complications after de novo heart transplantation .
BACKGROUND	To evaluate the possibility of a similar association for everolimus , we performed a risk-factor analysis to compare the incidence of incision-related wound complications for everolimus with that of other adjunctive drugs .
METHODS	Safety data from 1009 heart transplant recipients ( n = 214 , receiving azathioprine ; n = 84 , mycophenolate mofetil ( MMF ) ; n = 711 , everolimus ) were reviewed in a post hoc analysis from three randomized , multicenter studies-B253 ( n = 634 ) , A2403 ( n = 199 ) , and A2411 ( n = 176 ) - in which de novo patients received fixed-dose or concentration-controlled everolimus ( target trough , 3-8 ng/mL ) , azathioprine , or MMF with standard - or reduced-exposure cyclosporine A. Incisional complications were analyzed for incidence , type , and severity up to day 90 posttransplant .
RESULTS	Incisional-complication events occurred in 25 ( 11.7 % ) azathioprine , six ( 7.2 % ) MMF , and 87 ( 12.3 % ) everolimus patients .
RESULTS	Serious incisional complications were more frequent with everolimus ( 6.9 % ) compared with azathioprine ( 4.2 % ; P = 0.197 ) or MMF ( 1.2 % ; P = 0.051 ) .
RESULTS	In a univariate analysis , patient sex , body mass index ( BMI ) , and diabetes were associated with incisional complications .
RESULTS	Only BMI was significantly associated with incisional complications in the subsequent multivariate analysis , with the odds of an incisional-complication event increasing by 12.9 % for every 1 kg/m increase in BMI ( P < 0.001 ) .
CONCLUSIONS	The incidence of incisional complications with everolimus was generally low , although numerically higher compared with MMF .
CONCLUSIONS	Our analyses provided no strong evidence that everolimus is an independent risk factor for incisional complications .
CONCLUSIONS	After de novo heart transplantation , patients with a high BMI are at higher risk of incision-related wound complications .

###22495093
BACKGROUND	Many older people with neuropsychiatric disorders such as Alzheimer 's disease and frontotemporal dementia suffer from sleeping problems and often show nocturnal restlessness .
BACKGROUND	Professionals and informal carers face considerable problems in solving these problems .
BACKGROUND	Attempts to diminish these problems with medication in a safe and responsible manner have proven hardly effective or not effective at all .
BACKGROUND	Therefore , nowadays the focus lies more on non-pharmacological solutions , for example by influencing environmental factors .
BACKGROUND	There are indications that treatment with low-frequency acoustic vibrations , that is Physio Acoustic Sound ( PAS ) therapy , has a positive effect on sleeping problems .
BACKGROUND	Therefore we study the effectiveness of PAS therapy in demented patients with nocturnal restlessness .
METHODS	In a randomized clinical trial , 66 nursing home patients will be divided into two groups : an intervention group and a control group .
METHODS	For both groups nocturnal restlessness will be measured with actiwatches during a period of six weeks .
METHODS	In addition , a sleep diary will be filled in.For the intervention group the baseline will be assessed , in the first two weeks , reflecting the existing situation regarding nocturnal restlessness .
METHODS	In the next two weeks , this group will sleep on a bed identical to their own , but with a mattress containing an in-built PAS device .
METHODS	As soon as the patient is lying in bed , the computer programme inducing the vibrations will be switched on for the duration of 30 min .
METHODS	In the last two weeks , the wash-out period , the measurements of the intervention group are continued , without the PAS intervention.During the total study period , other relevant data of all the implied patients will be recorded systematically and continuously , for example patient characteristics ( data from patient files ) , the type and seriousness of the dementia , occurrence of neuropsychiatric symptoms during the research period , and the occurrence of intermittent co-morbidity .
CONCLUSIONS	If PAS therapy turns out to be effective , it can be of added value to the treatment of nocturnal restlessness in demented patients .
CONCLUSIONS	Non-pharmacological PAS therapy is not only safe and patient-friendly , but it can also be widely used in a simple and relatively inexpensive way , both in institutions such as nursing homes and residential homes for the elderly , and at home .
CONCLUSIONS	Ultimately , this may lead to a decrease in the frequent and still common use of psychotropic drugs .
CONCLUSIONS	In addition , care needs of demented patients also may decrease as well as the number of preventable admissions to care institutions .
BACKGROUND	Netherlands Trial Register ( NTR ) : NTR3242 .

###22127418
OBJECTIVE	Professional practice guidelines recommend that pacemaker recipients be followed regularly .
OBJECTIVE	However , the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the health-care system .
RESULTS	The COMPAS randomized , multicentre , non-inferiority trial examined the safety of long-term remote monitoring of pacemakers .
RESULTS	Between December 2005 and January 2008 , 538 patients were randomly assigned to remote monitoring follow-up ( active group ) vs. standard care ( control group ) .
RESULTS	The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event ( MAE ) , including all-cause death and hospitalizations for device-related or cardiovascular adverse events , was not > 7 % higher in the active than in the control group .
RESULTS	MAE-free survivals and quality of life were compared in both groups .
RESULTS	The characteristics of the study groups were similar .
RESULTS	Over a follow-up of 18.3 months , 17.3 % of patients in the active and 19.1 % in the control group experienced at least one MAE ( P < 0.01 for non-inferiority ) .
RESULTS	Hospitalizations for atrial arrhythmias ( 6 vs. 18 ) and strokes ( 2 vs. 8 ) were fewer ( P < 0.05 ) , and the number of interim ambulatory visits was 56 % lower ( P < 0.001 ) in the active than the control group .
RESULTS	Changes in pacemaker programming or drug regimens were made in 62 % of visits in the active vs. 29 % in the control group ( P < 0.001 ) .
RESULTS	Quality of life remained unchanged in both groups .
CONCLUSIONS	Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00989326 .

###16801738
OBJECTIVE	To investigate the effects of a pharmacotherapy ( orlistat ) plus lifestyle management ( OLM ) intervention on weight loss in Mexican American women with and without metabolic syndrome ( MS ) .
METHODS	One hundred and seven female participants aged 21-65 years and of Mexican origin were randomized to either OLM or a wait-list control group ( WLC ) for one year .
METHODS	The lifestyle interventions were tailored to exhibit features of the Mexican culture .
METHODS	Within each group , subjects with MS were compared to those without MS to assess whether its presence mitigates weight loss .
METHODS	Risk factors for MS also were assessed .
RESULTS	Participants with MS in the OLM group experienced significant decreases in weight and body mass index ( BMI ) as compared to participants without MS. Participants with MS in the OLM group and who completed the study lost 9.3 + / -7.5 kg ( 20.5 + / -16.5 lb ) as compared to participants with MS in the WLC group , who only lost 0.2 + / -3.1 kg ( 0.4 + / -6.8 lb ) .
RESULTS	Further , participants with MS in the OLM group who completed the study experienced a 3.1 + / -3.9 kg/m2 decrease in BMI whereas participants with MS in the WLC group only experienced a 0.1 + / -1.2 kg/m2 decrease in BMI .
RESULTS	No changes in other MS risk factors were significant .
CONCLUSIONS	Patients with MS experienced significant weight loss and decreases in BMI as a result of a lifestyle and pharmacotherapy intervention .

###10191892
BACKGROUND	Monosymptomatic nocturnal enuresis is common in healthy school children .
BACKGROUND	Treatment is often required because of social and psychological convenience .
BACKGROUND	We therefore conducted a randomized prospective trial using either desmopressin ( D ) or alarm ( A ) .
METHODS	Patients ( n = 135 ) aged 6 to 16 years were enrolled between January 1992 and December 1994 .
METHODS	Desmopressin ( Minirin spray , Ferring SA ) was given intranasally at a dose of 20 micrograms at bedtime and increased to 40 micrograms after 2 weeks if partial result was obtained .
METHODS	The alarm was a pad-bell device ( Wet-stop , Sega ) and the sound source was attached to the upper part of the pajamas .
METHODS	Inclusion criteria were : primary monosymptomatic nocturnal enuresis in healthy children , age > or = 6 years , absence of previous treatment using either desmopressin or alarm .
METHODS	The aim of the treatment was to achieve 100 % dry nights .
METHODS	Patients were evaluated after 15 days on therapy by phone call and thereafter by attending the outpatient clinic at 2-3 and 4-6 months .
METHODS	At the time of the second evaluation , a switch from alarm to desmopressin ( or vice-versa ) was proposed to those who did not respond to the initial treatment .
RESULTS	In group D ( n = 62 ) , only 27 children were included since 12 ( 19 % ) were switched to alarm and 23 ( 37 % ) were excluded because they were either non-compliant or lost to follow-up .
RESULTS	In group A ( n = 73 ) , only 31 were included since six ( 8 % ) were switched to desmopressin and 36 ( 49 % ) were excluded for the same reasons as in group D. Prior to inclusion , the percentage of dry nights was 21 % in group D and 14 % in group A.
RESULTS	After 15 days on therapy , patients from group D achieved 80 % dry nights compared to 50 % in group A ( P = 0.001 ) .
RESULTS	After 3 months , patients from group D attained 85 % dry nights vs 90 % in group A.
RESULTS	After 6 months , children from group A achieved 94 % dry nights vs 78 % in group D ( P = 0.01 ) .
CONCLUSIONS	Desmopressin offers better short-term results than enuresis alarm but the latter is significantly more efficient in the long term .
CONCLUSIONS	In France , the alarm device is not reimbursed by the national health service and therefore is poorly accepted , as suggested from the high rate of patients lost to follow-up .

###17108825
METHODS	A randomized controlled trial .
OBJECTIVE	To evaluate the long-term efficacy of infliximab , a monoclonal antibody against tumor necrosis factor alpha ( TNF-alpha ) , in patients with acute/subacute sciatica secondary to herniated disc .
BACKGROUND	The results of experimental studies and our open-label trial support the use of infliximab in sciatica .
BACKGROUND	Here we report the 1-year results of a randomized controlled trial ( FIRST II , Finnish Infliximab Related STudy ) evaluating the efficacy and safety of a single infusion of infliximab for sciatic pain .
METHODS	Inclusion criteria were unilateral sciatic pain with a disc herniation concordant with the symptoms and signs of radicular pain .
METHODS	Patients had to be candidates for discectomy .
METHODS	Criteria for discectomy included ( in addition to a symptomatic disc herniation on MRI ) neural entrapment ( straight leg raising [ SLR ] < or = 60 degrees ) with either a short-term ( 2-4 weeks ) severe or long-term ( 4-12 weeks ) moderate leg pain .
METHODS	Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo .
METHODS	Differences in the clinical examination parameters ( straight leg raise [ SLR ] , muscle strength , sensory defects , tendon reflexes ) , patient-reported symptoms ( leg and back pain using a visual analog scale [ VAS ] , Oswestry disability , quality-of-life [ RAND-36 ] ) , sick leaves , number of discectomies , and adverse effects between the two treatment groups over the 1-year follow-up were compared using Mann-Whitney U test or Student 's t test , repeated-measures analysis , or Cox proportional hazards model .
METHODS	Logistic regression was used to assess the predictors of good response .
RESULTS	Sixty-seven percent of patients in the infliximab group reported no pain at 52 weeks compared with 63 % in the control group ( P = 0.72 ) .
RESULTS	Similar efficacy was observed between treatment groups for other outcomes .
RESULTS	Eight patients in each group required surgery .
RESULTS	Three nonserious adverse reactions were encountered in the infliximab group .
RESULTS	The response ( irrespective of the treatment ) was significantly better with shorter symptom duration and less SLR restriction at baseline .
RESULTS	Patients in the infliximab group appeared to especially benefit in cases of a L4-L5 ( or L3-L4 ) herniation and if a Modic change was colocalized at the symptomatic level .
CONCLUSIONS	Although the long-term results of this randomized trial do not support the use of infliximab compared with placebo for lumbar radicular pain in patients with disc herniation-induced sciatica , further study in a subgroup of patients with L4-L5 or L3-L4 herniations , especially in the presence of Modic changes , appears to be warranted .

###12963609
BACKGROUND	In a 4-year placebo-controlled trial to elevate blood docosahexaenoic acid levels in patients with X-linked retinitis pigmentosa ( XLRP ) , the goal was to assess the potential benefit of docosahexaenoic acid supplementation in altering disease progression .
BACKGROUND	However , docosahexaenoic acid ( 22:6 omega3 ) is a highly unsaturated fatty acid and considered a target molecule for free-radical oxidative damage .
BACKGROUND	Thus , nutritional provision of docosahexaenoic acid might lead to an increase in antioxidant stress .
BACKGROUND	Additional concerns , such as decreased platelet aggregation , increased bleeding time , and alterations in lipoprotein cholesterol levels , have been reported in supplementation studies with long-chain polyunsaturates .
OBJECTIVE	To assess the biological safety of long-term docosahexaenoic acid supplementation .
METHODS	Forty-four male patients ( mean age , 16 years ) enrolled in a randomized , double-masked , clinical trial and received docosahexaenoic acid , 400 mg/d , or placebo .
METHODS	Blood samples were collected every 6 months .
METHODS	Biological safety analysis included fatty acids , vitamin A and E concentrations , antioxidant capacity , platelet aggregation , alanine aminotransferase activity , and lipoprotein cholesterol and triglyceride profiles .
RESULTS	Mean plasma docosahexaenoic acid levels were elevated 2.5-fold by supplementation compared with baseline .
RESULTS	Patients receiving placebo capsules exhibited no change ( P = .35 ) in plasma docosahexaenoic acid content .
RESULTS	All adverse events reported were minor and equivalently distributed between groups .
RESULTS	Plasma vitamin A concentrations remained unchanged during the trial .
RESULTS	Mean plasma vitamin E concentrations were correlated with age ( P = .005 ) , such that as patients with XLRP matured , plasma vitamin E concentrations increased to approach normal values .
RESULTS	There was a trend ( P = .10 ) toward lower mean vitamin E concentrations in the docosahexaenoic acid-supplemented group after 4 years .
RESULTS	Docosahexaenoic acid supplementation did not compromise plasma antioxidant capacity , platelet aggregation , liver function enzyme activity , or plasma lipoprotein lipid content in patients with XLRP .
CONCLUSIONS	Long-term docosahexaenoic acid supplementation to patients with XLRP was associated with no identifiable safety risks in this 4-year clinical trial .

###15325678
OBJECTIVE	We investigated the effects of dietary fiber on symptoms of irritable bowel syndrome .
METHODS	A single-blind randomized clinical trial was designed .
METHODS	Fifty-six subjects with irritable bowel syndrome were prospectively and randomly assigned to one of two groups : group 1 received a diet containing 10.4 g/d of fiber and group 2 received a diet containing 30.5 g/d of fiber .
METHODS	Patients ' body weights , nutritional intakes as assessed with 3-d written food records , and symptom scores were assessed at baseline and at 3 mo. .
RESULTS	There were no dropouts during the study .
RESULTS	Total energy intake and the distribution of macronutrients were not significantly different between groups .
RESULTS	Total dietary fiber intake did not reach recommended levels in either group but was higher in group 2 than in group 1 ( 25.95 + / - 2.12 g/d versus 6.06 + / - 2.7 g/d , P < 0.05 ) .
RESULTS	Initial fiber intake did not differ significantly between groups .
RESULTS	Pain scores , bowel scores , and general scores improved in both groups ( from baseline to 3 mo ) , and no significant differences were detected between groups .
CONCLUSIONS	A modest fiber intake in patients with irritable bowel syndrome relieved symptoms , but this therapeutic benefit of fiber may have been due to a placebo effect because the results were similar in the low-fiber group .

###21461891
OBJECTIVE	Brivanib alaninate , an orally available prodrug of brivanib , is currently under evaluation for the treatment of several malignancies .
OBJECTIVE	This study aimed to ( 1 ) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in subjects with advanced/metastatic solid tumors and ( 2 ) assess the safety and preliminary efficacy of single and multiple doses of brivanib alaninate in this population .
METHODS	A two-part study was conducted consisting of a single-dose phase ( Part A ) and a multiple-dose phase ( Part B ) .
METHODS	In Part A , subjects received a single dose of brivanib alaninate ( 800 mg ) either in a fasting state or following ingestion of a high-fat meal ( approximately 951 kcal [ 15 % protein , 33 % carbohydrate , 52 % fat ] ) ; serial blood samples were collected for pharmacokinetic analysis up to 48 h post-dosing .
METHODS	In Part B , subjects received brivanib alaninate ( 800 mg ) once daily until discontinuation .
METHODS	Throughout both phases , subjects were evaluated for adverse events ( AEs ) and best clinical response .
RESULTS	No clinically significant differences in brivanib exposure were observed between fed and fasting subjects in Part A ; C ( max ) was unchanged and AUC ( INF ) decreased marginally when administered in a fed versus fasted state .
RESULTS	In Part A , the incidence of treatment-emergent AEs was broadly similar in a fed or fasted state .
RESULTS	Brivanib alaninate was generally well tolerated throughout the study and showed preliminary evidence of antitumor activity .
CONCLUSIONS	Consumption of a high-fat meal had no significant effect on brivanib pharmacokinetics .
CONCLUSIONS	The study further demonstrates the acceptable safety/tolerability profile and antitumor potential of brivanib in patients with advanced malignancies .

###18718737
OBJECTIVE	This study evaluated the glycemic , insulinemic , and glucagon-like peptide-1 ( GLP-1 ) responses of subjects with type 2 diabetes mellitus to consumption of two diabetes-specific tube-feeding formulas ( slowly digested carbohydrate formula [ SDC ] and diabetes-specific formula [ DSF ] ) and one formula intended for individuals without diabetes ( standard formula [ STND ] ) .
METHODS	Forty-eight subjects controlled with diet and/or oral antihyperglycemic medications received the SDC , DSF , and STND .
METHODS	Postprandial glucose , insulin , and GLP-1 were measured on three occasions after an overnight fast in a double-blinded , randomized , three-treatment , crossover design .
RESULTS	The positive area under the curve for glucose and insulin with the STND was higher ( P < 0.001 ) compared with the SDC and DSF .
RESULTS	The adjusted GLP-1 concentration at 60 min was higher for the SDC compared with the DSF and STND ( P < 0.05 ) .
CONCLUSIONS	Both lower-carbohydrate diabetes-specific formulas resulted in a lower postprandial blood glucose response compared with the STND .
CONCLUSIONS	The formula also rich in slowly digested carbohydrate and monounsaturated and omega-3 fatty acids ( SDC ) produced significantly lower blood glucose and insulin responses and higher levels of GLP-1 in the presence of significantly lower insulin concentrations .
CONCLUSIONS	These results support the view that the quantity and quality of carbohydrate and fat may play important roles in the management of patients with type 2 diabetes mellitus and could result in improved beta-cell function over the long term .

###8558208
OBJECTIVE	To evaluate the hypocalcemic effect and safety of three different doses of the bisphosphonate ibandronate in tumor-associated hypercalcemia , and to identify factors predicting response .
METHODS	One hundred seventy-four cancer patients with a serum calcium level greater than 2.7 mmol/L ( 10.8 mg/dL ) were enrolled onto the trial .
METHODS	If hypercalcemia persisted after fluid repletion , patients were randomly assigned to treatment with 0.6 mg , 1.1 mg , and 2.0 mg of ibandronate .
METHODS	Response , defined as restoration of normocalcemia , was evaluated by an intent-to-treat analysis .
RESULTS	One hundred seventy-three ( 99 % ) patients were assessable for toxicity and 151 ( 87 % ) for efficacy .
RESULTS	The administration of 0.6 mg ( group A ) , 1.1 mg ( group B ) , or 2.0 mg ( group C ) of ibandronate led to response rates of 44 % , 52 % , and 67 % , respectively .
RESULTS	Significantly more patients in group C responded than in group A ( P = .0276 ) .
RESULTS	Of the various parameters examined , only the initial serum calcium level ( P < .0001 ; odds ratio , 0.083 ) and the dose of ibandronate ( P = .0162 ; odds ratio , 2.094 ) correlated with response .
RESULTS	One hundred ninety-five adverse events ( AEs ) were reported , 99 classified as serious and 96 as nonserious .
RESULTS	Three serious and sixteen nonserious AEs were considered related to ibandronate treatment .
RESULTS	The three serious AEs were one case with thrombocytopenia , one with nausea , and one with fever .
CONCLUSIONS	Ibandronate therapy led to a dose-dependent reduction in serum calcium levels .
CONCLUSIONS	The response to ibandronate treatment correlated negatively with the initial serum calcium level and positively with the dose administered .
CONCLUSIONS	A dose of 2 mg was necessary to achieve a response rate comparable to that in previous studies with the bisphosphonates pamidronate and clodronate .
CONCLUSIONS	Because the incidence of drug-associated AEs was low , a dose escalation of ibandronate can be recommended for further clinical trials .

###18575308
OBJECTIVE	To compare the effect on the shear bond strength of orthodontic brackets when applying Pro Seal light-cure varnish to the enamel surface either before or after the application of sealant .
METHODS	Sixty noncarious premolars were randomly divided into 3 equal groups .
METHODS	In groups I and 2 , Pro Seal , a fluoride-releasing light-cure varnish , was applied to the enamel surface before or after , respectively , the sealant provided with the adhesive , while group 3 ( control ) was bonded regularly using only the sealant supplied with the adhesive .
METHODS	Mono-Lok 2 no-mix bonding system was used to bond stainless steel brackets to each tooth .
METHODS	All teeth were embedded in self-cure acrylic , placed in steel rings , and secured in a jig attached to the base plate of a universal testing machine .
METHODS	A perpendicular force was applied to the bracket at a crosshead speed of 0.5 mm/min .
METHODS	The residual adhesive on the enamel surface was evaluated after debonding with the adhesive remnant index .
RESULTS	The mean shear bond strength for group 1 , treated with Pro Seal varnish before the sealant , was 10.06 + / - 3.11 MPa .
RESULTS	However , for group 2 , where varnish was applied after the sealant , the mean shear bond strength was 12.78 + / - 3.7 MPa , while it was 12.81 + / - 2.6 MPa for the control group .
RESULTS	An analysis of variance test showed that the mean shear bond strengths of the 3 groups were not significantly different .
RESULTS	The chi-square test evaluating the residual adhesive on enamel surfaces showed no significant differences between all groups .
CONCLUSIONS	Application of Pro Seal before or after the sealant did not reduce the mean shear bond strength of orthodontic brackets .
CONCLUSIONS	However , further studies are recommended to compare the amount of enamel protection offered in either situation .

###23385792
OBJECTIVE	We investigated the effect of daily supplementation with lutein ( L ) capsules on macular pigment optical density ( MPOD ) and visual acuity ( VA ) in patients with early age-related macular degeneration ( AMD ) .
METHODS	A randomized , double-blind , placebo-controlled , two-center investigation of the effects of L supplementation in early AMD was conducted .
METHODS	The duration of the trial was 12 months .
METHODS	The centers were Manchester , United Kingdom and Maastricht , the Netherlands .
METHODS	L capsules ( 10 mg Ester ) or a placebo ( P ) were taken daily .
METHODS	There were 72 patients ( mean age 70.5 8.7 ) assigned randomly to either L ( n = 36 ) or P ( n = 36 ) groups .
METHODS	MPOD using a flicker-based technique ( MPS9000 ) and best corrected VA ( LogMAR ) were measured at the beginning and at 4-month intervals over the duration of the 12-month supplementation period .
METHODS	Blood serum samples were collected to monitor compliance .
RESULTS	At the end of the trial , an overall increase in the mean MPOD level was found for the L group from 0.38 0.19 to 0.53 0.22 optical density ( OD ) units .
RESULTS	According to a mixed design ANOVA , this was statistically significant ( P < 0.001 ) .
RESULTS	No change in MPOD was found for the P group .
RESULTS	There was no significant change in VA in the L group ( n = 36 ) .
RESULTS	The P group ( n = 36 ) showed a statistically significant deterioration from 0.05 0.13 to 0.09 0.13 ( P < 0.05 ) .
RESULTS	When comparing the change in VA over the supplementation period , there was a significant difference between the two groups ( P < 0.05 ) .
RESULTS	To avoid ceiling effects , 2 subgroups of patients with VA worse than 0.06 at baseline were reanalyzed .
RESULTS	In the L subgroup ( n = 19 ) a mean improvement in VA from 0.23 0.12 at baseline to 0.16 0.10 at visit 4 was observed ( P < 0.05 ) .
RESULTS	In the P subgroup ( n = 14 ) , there was a small deterioration from 0.18 0.13 to 0.19 0.12 ( P = 0.70 ) .
RESULTS	The improvement in VA in the L subgroup was compared to the deterioration in VA in the P group and this effect reached statistical significance ( P < 0.05 ) .
CONCLUSIONS	L supplementation increases MPOD levels in early stage AMD patients .
CONCLUSIONS	According to the VA measurements , the progress of the disease might be slowed in some patients with augmented levels of MP .
CONCLUSIONS	( ClinicalTrials.gov number NCT01042860 . )

###25569524
METHODS	Randomized trial with a concurrent observational cohort study .
OBJECTIVE	To compare 8-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis .
BACKGROUND	Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during 4 years , but longer-term data are less clear .
METHODS	Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort .
METHODS	Treatment was standard , decompressive laminectomy versus standard nonoperative care .
METHODS	Primary outcomes were SF-36 ( MOS 36-Item Short-Form Health Survey ) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at 6 weeks , 3 months , 6 months , and yearly up to 8 years .
RESULTS	Data were obtained for 55 % of participants in the randomized group and 52 % of participants in the observational group at the 8-year follow-up .
RESULTS	Intent-to-treat analyses showed no differences between randomized cohorts ; however , 70 % of those randomized to surgery and 52 % of those randomized to nonoperative had undergone surgery by 8 years .
RESULTS	As-treated analyses in the randomized group showed that the early benefit for surgery out to 4 years converged over time , with no significant treatment effect of surgery seen in years 6 to 8 for any of the primary outcomes .
RESULTS	In contrast , the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8 .
RESULTS	Patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first 2 years in both surgical and nonoperative arms .
CONCLUSIONS	Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between 4 and 8 years , whereas outcomes in the observational group remained stable .
CONCLUSIONS	Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates .

###15747269
OBJECTIVE	Effective postoperative analgesia is a critical part of fast-track cardiac surgery .
OBJECTIVE	This study compared the postoperative analgesic effect of fast-track anesthesia with remifentanil and spinal morphine and clonidine with that of sufentanil anesthesia followed by patient-controlled administration of intravenous morphine .
METHODS	Prospective , blinded , randomized study .
METHODS	Single private institution .
METHODS	Forty patients selected for coronary artery bypass graft surgery allocated randomly into 2 groups .
METHODS	General anesthesia was performed with etomidate , isoflurane , cisatracurium , and either remifentanil ( 0.10-0 .25 microg/kg/min ) or sufentanil ( up to 3.5 microg/kg ) .
METHODS	In the remifentanil group , patients received spinal morphine ( 4 microg/kg ) and clonidine ( 1 microg/kg ) before induction .
METHODS	Postoperatively , patients in both groups were connected to an intravenous patient-controlled analgesia ( PCA ) morphine pump that delivered a 1-g bolus with a 7-minute lockout interval .
RESULTS	Patients were evaluated for pain on a visual analog scale ( VAS ) , at rest and on deep breathing , and for intravenous PCA morphine consumption during 24 hours .
RESULTS	The intravenous PCA morphine 24-hour cumulative dose was lower in the fast-track than in the control group ( 15.8 + / -12.6 v 32.7 + / -22.3 mg , p < 0.05 ) .
RESULTS	Before extubation , VAS scores were higher in the fast-track group , but after they were lower both at rest and during deep breathing .
RESULTS	Extubation delay was shorter in the fast-track group ( 156.5 + / -46.1 v 272 + / -116.4 minutes , p < 0.05 ) .
CONCLUSIONS	The combination of anesthesia with remifentanil and spinal analgesia with morphine and clonidine produces effective analgesia after coronary artery surgery and a rapid extubation time .

###11093698
BACKGROUND	A deficiency of alpha-1 antitrypsin ( AAT ) can lead to pulmonary disease in middle-aged adults in whom dyspnea management can be a significant issue .
OBJECTIVE	The research addressed whether short-term oxygen ( O2 ) administration during activities might decrease dyspnea and improve exercise performance in nonhypoxemic patients with emphysema caused by a deficiency of alpha-1 antitrypsin .
METHODS	This was a double-blind , randomized crossover study of 31 subjects with a deficiency of AAT ( mean + SD , age = 47 + / - 7 ) , moderate emphysema and a resting PaO2 > 70 mm Hg .
METHODS	Oxygen saturation ( SpO2 ) , 6-minute walk distance , and end of walk dyspnea were measured during three practice walks and during walks with nasal cannula administration of O2 ( intervention ) and compressed air ( control ) .
RESULTS	Repeated measures analysis of variance ( ANOVA ) showed significant differences across the walks for SpO ( F = 18.9 , p = 0.0001 ) , 6-minute walk distance ( F = 6.07 , p = 0.004 ) , and dyspnea ( F = 4.44 , p = 0.016 ) .
RESULTS	Using post hoc contrasts , SpO2 was the only variable that differed between 20 , and compressed air ( p < 0.0001 ) .
RESULTS	There was , however , an interaction effect of gender with O2 for dyspnea ( F = 9.85 , p = 0.004 ) .
RESULTS	Mean values showed that men did not benefit from O2 ( p = 0.87 ) .
RESULTS	However , women experienced less dyspnea when receiving O2 as compared with compressed air ( p = 0.0025 ) , and although not statistically significant , the lower dyspnea with O2 corresponded with an increased walk distance of 79 feet .
CONCLUSIONS	O2 administration may be useful for reducing dyspnea during exercise in selected populations .

###15704509
OBJECTIVE	To evaluate the effects of additional physical therapy on recovery after acute unilateral vestibular loss given to patients receiving home training .
METHODS	Randomized controlled trial .
METHODS	Ear , nose and throat departments in three hospitals .
METHODS	Fifty-four patients ( mean age 52 years ) with acute unilateral vestibular loss within the last week confirmed with electronystagmography testing were included .
METHODS	Patients with central neurologic or auditory symptoms or other vertigo disease were excluded .
METHODS	Home training with or without additional physical therapy 12 times during 10 weeks .
METHODS	Electronystagmography testing was performed before and after the training period .
METHODS	Clinical static ( Romberg 's test , sharpened Romberg 's test , standing on foam and standing on one leg ) and dynamic ( walking forward and backward on a line ) balance tests and subjective ratings of vertigo and balance problems on a visual analogue scale were done one week , 10 weeks and six months after the start of training .
RESULTS	Similar changes were seen in the two training groups .
CONCLUSIONS	No significant differences in outcome regarding balance function or perceived symptoms were found between home training with or without additional physical therapy .

###22402864
OBJECTIVE	To determine whether pentoxifylline ( PTX ) slows the decline of muscle strength and function in ambulatory boys with Duchenne muscular dystrophy ( DMD ) .
METHODS	This was a multicenter , randomized , double-blinded , controlled trial comparing 12 months of daily treatment with PTX or placebo in corticosteroid-treated boys with DMD using a slow-release PTX formulation ( ~ 20 mg/kg/day ) .
METHODS	The primary outcome was the change in mean total quantitative muscle testing ( QMT ) score .
METHODS	Secondary outcomes included changes in QMT subscales , manual muscle strength , pulmonary function , and timed function tests .
METHODS	Outcomes were compared using Student t tests and a linear mixed-effects model .
METHODS	Adverse events ( AEs ) were compared using the Fisher exact test .
RESULTS	A total of 64 boys with DMD with a mean age of 9.9 2.9 years were randomly assigned to PTX or placebo in 11 participating Cooperative International Neuromuscular Research Group centers .
RESULTS	There was no significant difference between PTX and the placebo group in total QMT scores ( p = 0.14 ) or in most of the secondary outcomes after a 12-month treatment .
RESULTS	The use of PTX was associated with mild to moderate gastrointestinal or hematologic AEs .
CONCLUSIONS	The addition of PTX to corticosteroid-treated boys with DMD at a moderate to late ambulatory stage of disease did not improve or halt the deterioration of muscle strength and function over a 12-month study period .
METHODS	This study provides Class I evidence that treatment with PTX does not prevent deterioration in muscle function or strength in corticosteroid-treated boys with DMD .

###14745756
OBJECTIVE	To prove the feasibility of air-distended magnetic resonance colonography ( MRC ) and compare it with water-based distention .
METHODS	In five volunteers , the colon was imaged twice : once after distending the colon with air and a second time after distending the colon with water .
METHODS	A total of 50 patients , who had been referred to colonoscopy for a suspected colorectal pathology were randomized into water-distention ( N = 25 ) and air-distention ( N = 25 ) groups .
METHODS	A contrast-enhanced T1-weighted three-dimensional volume interpolated breath-hold ( VIBE ) sequence was collected .
METHODS	Comparative analysis was based on qualitative ratings of image quality and bowel distention , as well as contrast-to-noise ratio ( CNR ) measurements for the colonic wall with respect to the colonic lumen .
METHODS	In addition , patient acceptance was evaluated .
RESULTS	Inflammatory changes and colorectal masses were correctly identified on MRC in eight patients each .
RESULTS	One 4-mm polyp identified at colonoscopy was missed on water-distended MRC .
RESULTS	There were no false positive findings .
RESULTS	No significant differences were found between air - and water-distention regarding discomfort levels and image quality .
RESULTS	The presence of air in the colonic lumen was not associated with susceptibility artifacts .
RESULTS	CNR of the contrast-enhanced colonic wall , as well as bowel distention , were superior on air-distended three-dimensional data sets .
CONCLUSIONS	MRC can be performed using either water or air for colonic distention .
CONCLUSIONS	Both techniques permit assessment of the colonic wall and identification of colorectal masses .
CONCLUSIONS	While discomfort levels are similar for both agents , MRC with air provides higher CNR and better colonic distention .

###15727589
BACKGROUND	Prototype nasal filters were developed to collect inhaled pollen .
BACKGROUND	This study evaluated the efficacy of the filters for prevention of rhinitis symptoms during acute outdoor pollen exposure .
METHODS	A randomized double-blind design was used .
METHODS	Subjects ( n = 46 ) with a history of autumn exacerbation of rhinitis and positive skin test to ragweed , Bermuda and/or Bahia grass wore either active or placebo nasal filters for 2 h in autumn in a park containing these species .
METHODS	Major and Total Symptoms scores were recorded at 0 , 30 , 60 , 90 and 120 min .
RESULTS	Subjects wearing active nasal filters had significantly reduced scores , at all time-points compared with placebo group ( all P < 0.05 ) .
RESULTS	Of 14 individual symptoms measured , seven were significantly reduced ( number of sneezes , runny nose , itchy nose , sniffles , itchy throat ; itchy eyes and watery eyes ) and another three showed a trend towards lower severity .
RESULTS	The nasal filters also enabled the resolution of existing symptoms .
RESULTS	Maximal difference in symptoms was seen immediately after subjects had spent 20 min sitting beside a large patch of ragweed .
CONCLUSIONS	This is the first clinical trial of a nasal filter .
CONCLUSIONS	The results suggest it has potential for enhancing rhinitis management during acute allergen exposure .

###15805203
BACKGROUND	Although the use of a sliding hip screw is considered to be the preferred treatment for pertrochanteric femoral fractures , we theorized that external fixation could produce clinical outcomes equal to , if not better than , the outcomes obtained with conventional treatment .
BACKGROUND	Furthermore , because external fixation is minimally invasive , we expected a lower rate of morbidity and a reduced need for blood transfusions .
BACKGROUND	Therefore , we compared the two treatments in a clinical trial of elderly patients with pertrochanteric fracture .
METHODS	Forty consecutive elderly female patients who had a pertrochanteric fracture were randomized to be treated with either fixation with a 135 degrees four-hole sliding hip screw ( Group A ) or an external fixation device with hydroxyapatite-coated pins ( Group B ) .
METHODS	The inclusion criteria were female gender , an age of at least sixty-five years , an AO/OTA type-A1 or A2 fracture , and a bone mineral density T-score of less than -2.5 .
METHODS	There were no differences in patient age , fracture type , bone mineral density , comorbidities , length of hospital stay , or quality of reduction between the two groups .
RESULTS	The average intraoperative time ( and standard deviation ) was 64 + / - 6 minutes in Group A and 34 + / - 5 minutes in Group B ( p < 0.005 ) .
RESULTS	The average number of units of blood transfused postoperatively was 2.0 + / - 0.1 in Group A and none in Group B ( p < 0.0001 ) .
RESULTS	Group B had less pain five days postoperatively ( p < 0.05 ) .
RESULTS	Varus collapse of the fracture at six months averaged 6 degrees + / - 8 degrees in Group A and 2 degrees 1 degrees in Group B ( p < 0.002 ) .
RESULTS	No pin-track infections occurred in Group B.
RESULTS	The average Harris hip score at six months was 62 + / - 19 points in Group A and 63 + / - 17 points in Group B.
CONCLUSIONS	This study showed that external fixation with hydroxyapatite-coated pins is an effective treatment for this fracture in this patient population .
CONCLUSIONS	The operative time is brief , the blood loss is minimal , the fixation is adequate , and the reduction is maintained over time .

###17324679
OBJECTIVE	To investigate the effect of mindfulness training on pain tolerance , psychological well-being , physiological activity , and the acquisition of mindfulness skills .
METHODS	Forty-two asymptomatic University students participated in a randomized , single-blind , active control pilot study .
METHODS	Participants in the experimental condition were offered six ( 1-h ) mindfulness sessions ; control participants were offered two ( 1-h ) Guided Visual Imagery sessions .
METHODS	Both groups were provided with practice CDs and encouraged to practice daily .
METHODS	Pre-post pain tolerance ( cold pressor test ) , mood , blood pressure , pulse , and mindfulness skills were obtained .
RESULTS	Pain tolerance significantly increased in the mindfulness condition only .
RESULTS	There was a strong trend indicating that mindfulness skills increased in the mindfulness condition , but this was not related to improved pain tolerance .
RESULTS	Diastolic blood pressure significantly decreased in both conditions .
CONCLUSIONS	Mindfulness training did increase pain tolerance , but this was not related to the acquisition of mindfulness skills .

###23025584
BACKGROUND	That alcohol consumption is strongly influenced by the drinking behavior of social company has been demonstrated in observational research .
BACKGROUND	However , not everyone is equally vulnerable to other people 's drinking , and it is important to unravel which factors underlie these individual differences .
BACKGROUND	This study focuses on the role of psychosocial stress in attempting to explain individual differences in the propensity to imitate alcohol consumption .
METHODS	With a 2 ( confederate 's drinking condition : alcohol vs. soda ) 2 ( participant 's stress condition : stress vs. no stress ) experimental design , we tested whether the tendency to imitate other people 's drinking was related to participants ' induced stress levels .
METHODS	The young male adults ( N = 106 ) were randomly assigned to each of the conditions .
METHODS	In each session , directly after the stress or no-stress period , confederates and participants entered a bar laboratory where we observed their drinking behavior .
METHODS	Prior to entering the session , confederates were instructed to drink alcohol or soda .
RESULTS	Participants in both stress and no-stress conditions consumed substantially more alcohol when confederates drank alcohol than when they drank soda .
RESULTS	There was no difference in alcohol consumed between stress and no-stress conditions .
RESULTS	No moderating effect of stress on the tendency to drink along with peers was found .
CONCLUSIONS	Generally , it appears that among young male adults , imitation of alcohol consumption is a robust phenomenon not dependent on individual stress levels .

###24428334
BACKGROUND	Models of addictive behaviors postulate that implicit alcohol-related memory associations and biased interpretation processes contribute to the development and maintenance of alcohol misuse and abuse .
BACKGROUND	The present study examined whether alcohol-dependent patients ( AP ) show an alcohol-related interpretation bias .
BACKGROUND	Second , the relationship between the interpretation bias and levels of harmful drinking was investigated .
METHODS	The sample included 125 clinically diagnosed AP and 69 clinically diagnosed control patients ( CP ) who had either a mood or an anxiety disorder .
METHODS	Participants completed a booklet containing 12 open-ended ambiguous scenarios .
METHODS	Seven scenarios were alcohol-relevant , and 5 were emotionally relevant , that is , panic - or depression-relevant .
METHODS	Participants were asked to read each scenario and to generate a continuation .
METHODS	In addition , the Alcohol Use Disorder Identification Test ( AUDIT ) and Beck Depression Inventory were administered .
RESULTS	Logistic multivariate multilevel analyses revealed that AP ' probability of generating an alcohol-related continuation on all 3 scenario types was higher than that of CP .
RESULTS	Moreover , alcohol-related interpretation biases were positively associated with levels of harmful drinking ( i.e. , AUDIT scores ) .
CONCLUSIONS	These findings are the first to show that AP show an alcohol-related interpretation bias , which generalizes to other ambiguous emotionally relevant contexts , and therefore advance our understanding of the role of implicit biased alcohol-related memory associations and interpretation processes .

###11980120
OBJECTIVE	To study effects of laser therapy in combined treatment of pneumonia on external respiration function , membrane permeability , microcirculation and serum trace elements .
METHODS	142 pneumonia patients were randomly divided into two groups : 96 patients treated with drugs and laser radiation ( the study group ) and 46 patients treated with drugs only ( control group ) .
RESULTS	In the study group there was more pronounced reduction in cell membrane permeability , a rise in concentrations of iron and chromium in the blood serum , improvement of microcirculation .
RESULTS	These changes closely correlated with those in immunity , external respiration function .
CONCLUSIONS	Laser therapy is an effective method of pneumonia treatment and can be included in relevant combined schemes .

###8182811
OBJECTIVE	To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer .
METHODS	Randomized controlled clinical trial .
METHODS	Multicenter study involving 26 general hospitals in Italy .
METHODS	A consecutive sample of 1320 women younger than 70 years with stage I , II , and III unilateral primary breast cancer .
METHODS	Patients were randomly assigned to an intensive surveillance , which included physician visits and performance of bone scan , liver echography , chest roentgenography , and laboratory tests at predefined intervals ( n = 655 ) , or to a control regimen ( n = 665 ) , in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed .
METHODS	Both groups received a yearly mammogram aimed at detecting contralateral breast cancer .
METHODS	Primary end points were overall survival and health-related quality of life .
RESULTS	Compliance to the two follow-up protocols was more than 80 % .
RESULTS	At a median follow-up of 71 months , no difference was apparent in overall survival with 132 deaths ( 20 % ) in the intensive group and 122 deaths ( 18 % ) in the control group .
RESULTS	No significant differences were apparent in time to detection of recurrence between the two groups .
RESULTS	Measurements of health-related quality of life ( ie , overall health and quality-of-life perception , emotional well-being , body image , social functioning , symptoms , and satisfaction with care ) at 6 , 12 , 24 , and 60 months of follow-up did not show differences by type of care received .
CONCLUSIONS	Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life .
CONCLUSIONS	Routine use of these tests should be discouraged .

###24299553
BACKGROUND	Oral contraceptives ( OC ) are effective for birth control and have good cycle control and tolerability .
BACKGROUND	However , the hormonal components could modify mood and libido .
OBJECTIVE	The aim of this study is to evaluate the genital vascular effects and sexual behavior of an OC containing 30 g ethinyl estradiol and 3 mg drospirenone in comparison with a flexible combined contraceptive vaginal ring .
METHODS	Forty women underwent a sonographic assessment of the clitoral anatomy and vascularization and were administered the McCoy Female Sexuality Questionnaire ( MFSQ ) and the Beck 's Depression Inventory questionnaire ( BDI ) .
METHODS	Estradiol , androstenedione , testosterone , and SHBG were assayed .
METHODS	Free Androgen Index ( FAI ) and Free Estrogen Index ( FEI ) were calculated .
METHODS	The patients were randomly submitted to OC ( group I ; n = 21 ) or vaginal ring ( group II ; n = 19 ) .
METHODS	Ultrasonographic clitoral volume , pulsatility index ( PI ) of dorsal clitoral arteries , MFSQ , BDI , and hormonal and biochemical assays were analyzed .
RESULTS	After therapy , the testosterone levels were reduced in both groups , whereas estradiol decreased only in group I women .
RESULTS	The SHBG increased in all the subjects , and both FAI and FEI decreased .
RESULTS	The clitoral volume decreased in all the women .
RESULTS	The PI of the dorsal clitoral artery increased only in patients on OC .
RESULTS	The hormonal contraception was associated , in both studied groups , with a significant decrease of the two-factor Italian MFSQ score , which was more marked in OC users .
RESULTS	In group I subjects , there was a reduction of the number of intercourse/week and a reduction of orgasm frequency during intercourse .
RESULTS	The pain during intercourse worsened after OC use .
RESULTS	The vaginal ring users reported a vaginal wetness .
CONCLUSIONS	Six-month treatment with hormonal contraception is associated with a diminished MFSQ score .
CONCLUSIONS	However , the frequency of sexual intercourse and orgasm was reduced only by the use of OC .
CONCLUSIONS	The OC use was associated with increased pain during intercourse .

###22150035
BACKGROUND	Treatment of latent Mycobacterium tuberculosis infection is an essential component of tuberculosis control and elimination .
BACKGROUND	The current standard regimen of isoniazid for 9 months is efficacious but is limited by toxicity and low rates of treatment completion .
METHODS	We conducted an open-label , randomized noninferiority trial comparing 3 months of directly observed once-weekly therapy with rifapentine ( 900 mg ) plus isoniazid ( 900 mg ) ( combination-therapy group ) with 9 months of self-administered daily isoniazid ( 300 mg ) ( isoniazid-only group ) in subjects at high risk for tuberculosis .
METHODS	Subjects were enrolled from the United States , Canada , Brazil , and Spain and followed for 33 months .
METHODS	The primary end point was confirmed tuberculosis , and the noninferiority margin was 0.75 % .
RESULTS	In the modified intention-to-treat analysis , tuberculosis developed in 7 of 3986 subjects in the combination-therapy group ( cumulative rate , 0.19 % ) and in 15 of 3745 subjects in the isoniazid-only group ( cumulative rate , 0.43 % ) , for a difference of 0.24 percentage points .
RESULTS	Rates of treatment completion were 82.1 % in the combination-therapy group and 69.0 % in the isoniazid-only group ( P < 0.001 ) .
RESULTS	Rates of permanent drug discontinuation owing to an adverse event were 4.9 % in the combination-therapy group and 3.7 % in the isoniazid-only group ( P = 0.009 ) .
RESULTS	Rates of investigator-assessed drug-related hepatotoxicity were 0.4 % and 2.7 % , respectively ( P < 0.001 ) .
CONCLUSIONS	The use of rifapentine plus isoniazid for 3 months was as effective as 9 months of isoniazid alone in preventing tuberculosis and had a higher treatment-completion rate .
CONCLUSIONS	Long-term safety monitoring will be important .
CONCLUSIONS	( Funded by the Centers for Disease Control and Prevention ; PREVENT TB ClinicalTrials.gov number , NCT00023452 . )

###23983460
OBJECTIVE	To study the feasibility of first , reaching functionally declined , but still independent older persons at risk of falls through their general practitioner ( GP ) and second , to reduce their physiological and psychological fall risk factors with a complex exercise intervention .
OBJECTIVE	We investigated the effects of a 16-week exercise intervention on physiological ( function , strength , and balance ) and psychological ( fear of falling ) outcomes in community-dwelling older persons in comparison with usual care .
OBJECTIVE	In addition , we obtained data on adherence of the participants to the exercise program .
METHODS	Tests on physical and psychological fall risk were conducted at study inclusion , and after the 16-week intervention period in the GP office setting .
METHODS	The 16-week intervention included progressive and challenging balance , gait , and strength exercise as well as changes to behavioral aspects .
METHODS	To account for the hierarchical structure in the chosen study design , with patients nested in GPs and measurements nested in patients , a three-level linear mixed effects model was determined for analysis .
RESULTS	In total , 33 GPs recruited 378 participants ( 75.4 % females ) .
RESULTS	The mean age of the participants was 78.1 years ( standard deviation 5.9 years ) .
RESULTS	Patients in the intervention group showed an improvement in the Timed-Up-and-Go-test ( TUG ) that was 1.5 seconds greater than that showed by the control group , equivalent to a small to moderate effect .
RESULTS	For balance , a relative improvement of 0.8 seconds was accomplished , and anxiety about falls was reduced by 3.7 points in the Falls Efficacy Scale-International ( FES-I ) , in the intervention group relative to control group .
RESULTS	In total , 76.6 % ( N = 170 ) of the intervention group participated in more than 75 % the supervised group sessions .
CONCLUSIONS	The strategy to address older persons at high risk of falling in the GP setting with a complex exercise intervention was successful .
CONCLUSIONS	In functionally declined , community-dwelling , older persons a complex intervention for reducing fall risks was effective compared with usual care .

###22640176
BACKGROUND	Exercise reduced tolerance and breathlessness are common in the elderly and can result in substantial loss in functionality and health related quality of life .
BACKGROUND	Heart failure ( HF ) and chronic obstructive pulmonary disease ( COPD ) are common underlying causes , but can be difficult to disentangle due to overlap in symptomatology .
BACKGROUND	In addition , other potential causes such as obesity , anaemia , renal dysfunction and thyroid disorders may be involved.We aim to assess whether screening of frail elderly with reduced exercise tolerance leads to high detection rates of HF , COPD , or alternative diagnoses , and whether detection of these diseases would result in changes in patient management and increase in both functionality and quality of life .
METHODS	A cluster randomized diagnostic trial .
METHODS	Primary care practices are randomized to the diagnostic-treatment strategy ( screening ) or care as usual .
METHODS	Frail ( defined as having three or more chronic or vitality threatening diseases and/or receiving five or more drugs chronically during the last year ) community-dwelling persons aged 65years and older selected from the electronic medical files of the participating general practitioners .
METHODS	Those with reduced exercise tolerance or moderate to severe dyspnoea ( 2 score on the Medical Research Counsel dyspnoea scale ) are included in the study.The diagnostic screening in the intervention group includes history taking , physical examination , electrocardiography , spirometry , blood tests , and echocardiography .
METHODS	Subsequently , participants with new diagnoses will be managed according to clinical guidelines .
METHODS	Participants in the control arm receive care as usual .
METHODS	All participants fill out health status and other relevant questionnaires at baseline and after 6months of follow-up .
CONCLUSIONS	This study will generate information on the yield of screening for previously unrecognized HF , COPD and other chronic diseases in frail elderly with reduced exercise tolerance and/or exercise induced dyspnoea .
CONCLUSIONS	The cluster randomized comparison will reveal whether this yield will result in subsequent improvements in functional health and/or health related quality of life .
BACKGROUND	ClinicalTrials.gov NCT01148719 .

###16529689
OBJECTIVE	To evaluate the efficacy and safety of thread-dragging through fistula method in treating patients with simple anorectal fistula .
METHODS	In this multi-centered , prospective , and randomized controlled clinical trial , 244 patients with simple low or high anorectal fistula were randomly divided into study group ( with the method of thread-dragging through fistula ) and control group ( with the method of incision or thread-drawing ) .
METHODS	The healing time and curative rate of anorectal fistula , and the integral calculus of clinical symptom and life quality evaluations before and after treatment were all examined .
METHODS	The maximal anal canal squeeze pressure was measured to compare the therapeutic safety between these two groups .
METHODS	The health economical benefits were also assessed to determine which therapeutic method was more economical .
RESULTS	The curative rate of simple low and high anorectal fistula were of no significant differences between the study group and the control group .
RESULTS	The healing time of simple low anorectal fistula in the study group and the control group were ( 22.26 + / -8.67 ) d and ( 31.41 + / -11.39 ) d respectively , while the healing time of simple high anorectal fistula in the study group and the control group were ( 24.73 + / -8.15 ) d and ( 32.20 + / -12.60 ) d respectively , and there revealed significant differences between these two groups .
RESULTS	Each integral calculus of clinical symptom evaluation in the study group was not obviously different from those in the control group besides the integral calculus of anal sphincter function .
RESULTS	The integral calculus of life quality between the study group and the control group of simple low anorectal fistula had no significant differences .
RESULTS	The integral calculus of anal sphincter function and confidence in treatment in the study group of high anorectal fistula were better than those in the control group .
RESULTS	The hospitalization expense of the study group was remarkably lower than that of the control group .
RESULTS	The maximal anal canal squeeze pressure in the study group after treatment was not reduced obviously as compared with that in the same group before treatment , while it was decreased significantly in the control group after treatment as compared with those in the same group before treatment and in the study group after treatment .
CONCLUSIONS	The method of thread-dragging through fistula in treating simple low and high anorectal fistula can shorten the course of the disease , save the hospitalization expenses , improve the life quality of the patients , and protect the anal sphincter function .

###23696211
BACKGROUND	Calcific tendinitis of the rotator cuff ( RCCT ) is frequently diagnosed in patients with shoulder pain , but there is no consensus on its treatment .
OBJECTIVE	To compare 2 regularly applied RCCT treatments : ultrasound ( US ) - guided needling and lavage ( barbotage ) combined with a US-guided corticosteroid injection in the subacromial bursa ( subacromial bursa injection [ SAI ] ) ( group 1 ) versus an isolated SAI ( group 2 ) .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	Patients were randomly assigned to the 2 groups .
METHODS	Shoulder function was assessed before treatment and at regular follow-up intervals ( 6 weeks and 3 , 6 , and 12 months ) using the Constant shoulder score ( CS , primary outcome ) , the Western Ontario Rotator Cuff Index ( WORC ) , and the Disabilities of the Arm , Shoulder and Hand questionnaire ( DASH ) .
METHODS	Additionally , calcification location , size , and Grtner classification were assessed on radiographs .
METHODS	Results were analyzed using the t test , linear regression , and a mixed model for repeated measures .
RESULTS	This study included 48 patients ( 25 female , 52.1 % ; mean age , 52.0 7.3 years ; 23 patients in group 1 ) with a mean baseline CS of 68.7 11.9 .
RESULTS	No patients were lost to follow-up .
RESULTS	Four patients in group 1 and 11 in group 2 ( P = .06 ) had an additional barbotage procedure or surgery during the follow-up period because of persisting symptoms and no resorption .
RESULTS	At 1-year follow-up , the mean CS in group 1 was 86.0 ( 95 % CI , 80.3-91 .6 ) versus 73.9 ( 95 % CI , 67.7-80 .1 ) in group 2 ( P = .005 ) .
RESULTS	The mean calcification size decreased by 11.6 6.4 mm in group 1 and 5.1 5.7 mm in group 2 ( P = .001 ) .
RESULTS	There was total resorption in 13 patients in group 1 and 6 patients in group 2 ( P = .07 ) .
RESULTS	With regression analyses , correcting for baseline CS and Grtner type , the mean treatment effect was 20.5 points ( P = .05 ) in favor of barbotage .
RESULTS	Follow-up scores were significantly influenced by baseline scores .
RESULTS	Results for the DASH and WORC were similar .
CONCLUSIONS	On average , there was improvement at 1-year follow-up in both treatment groups , but clinical and radiographic results were significantly better in the barbotage group .

###21916989
OBJECTIVE	The eradication rate of proton pump inhibitor ( PPI ) - based triple therapy for Helicobacter pylori ( H. pylori ) infection has decreased , mainly due to increasing antibiotic resistance , especially against clarithromycin .
OBJECTIVE	It has been reported that a 10-day sequential strategy can produce good outcomes .
OBJECTIVE	The aim of this prospective study was to assess the efficacy of sequential therapy as the first-line treatment for the eradication of H. pylori in Korea .
METHODS	A total of 116 patients with proven H. pylori infection received 10-day sequential therapy ( 20 mg rabeprazole and 1 g amoxicillin , twice daily for the first 5 days , followed by 20 mg rabeprazole , 500 mg clarithromycin , and 500 mg metronidazole , twice daily for the remaining 5 days ) ; 130 patients received 7-day triple therapy ( 20 mg rabeprazole , 500 mg clarithromycin , and 1 g amoxicillin , twice daily for 7 days ) .
METHODS	Eradication was evaluated by the ( 13 ) C-urea breath test , 4 weeks after the completion of treatment .
METHODS	Compliance and adverse events were assessed .
RESULTS	The eradication rates of 10-day sequential therapy and PPI-based triple therapy were 79.3 % ( 92/116 ) and 63 % ( 82/130 ) by intention-to-treat analysis , respectively ( P = 0.005 ) , and 81.9 % ( 91/111 ) and 64.5 % ( 82/127 ) by per protocol analysis , respectively ( P = 0.003 ) .
RESULTS	Mild adverse events occurred in both therapy groups ( 27.5 % vs 23.8 % ) , but both treatments were well tolerated .
CONCLUSIONS	The eradication rate of the 10-day sequential therapy regimen was significantly higher than that of PPI-based triple therapy in the Korean population .
CONCLUSIONS	Ten-day sequential therapy might be effective as a first-line treatment for H. pylori infection in Korea .

###17276267
OBJECTIVE	To evaluate the clinical effects of a primary posterior continuous curvilinear capsulorhexis ( PCCC ) on the intraocular performance of hydrophilic acrylic single-piece intraocular lenses ( IOLs ) with and without haptic angulation .
METHODS	Department of Ophthalmology , Medical University of Vienna , Vienna , Austria .
METHODS	A prospective study comprised 52 patients with bilateral age-related cataract who had standard cataract surgery including a PCCC .
METHODS	One eye of each patient was randomized to receive a hydrophilic acrylic IOL with haptic angulation ( ACR6D SE , Laboratoires Cornal ) and the contralateral eye , a hydrophilic acrylic IOL without haptic angulation ( C-flex 570C , Rayner ) .
METHODS	The following parameters were assessed : regeneratory posterior opacification ( RPO ) in the central , intermediate , and peripheral areas ( scale 0 to 10 ) ; anterior capsule opacification ( ACO ) ; best corrected visual acuity ( BCVA ) ; and contrast sensitivity ( CSF ) .
RESULTS	Thirty-one patients completed the 1 ( 1/2 ) - year follow-up .
RESULTS	In both IOL groups , RPO within the PCCC was slight in the central area , with a mean score of 0.33 + / - 0.84 ( SD ) in the angulated IOL group and 0.16 + / - 0.57 in the nonangulated IOL group ( P = .29 ) .
RESULTS	The mean RPO score in the peripheral area was 2.07 + / - 1.37 and 2.35 + / - 1.45 , respectively ( P = .12 ) .
RESULTS	The difference between the central and peripheral areas was 1.74 in the angulated IOL group ( P < .00001 ) and 2.19 in the nonangulated IOL group ( P < .00001 ) .
RESULTS	Haptic deformation occurred in 9 eyes ( 29 % ) with an angulated IOL and no eye with a nonangulated IOL .
RESULTS	There was significantly more ACO in the nonangulated IOL group ( P = .012 ) .
RESULTS	There were no significant differences in BCVA or CSF between the 2 groups .
CONCLUSIONS	Creating a PCCC led to significantly lower RPO intensity within the PCCC area than in the peripheral area in eyes with hydrophilic acrylic IOLs with and without haptic angulation .
CONCLUSIONS	Haptic angulation had no apparent significant influence on the intensity of RPO or on BCVA and CSF .
CONCLUSIONS	Haptic deformation may occur in hydrophilic IOLs with angulated haptics .

###25399616
BACKGROUND	Because excess sebum and/or metabolites of sebum induce skin problems , cleansers that can remove those kinds of sebum are sought after .
BACKGROUND	However , many people , especially who have little facial sebum , are afraid to wash off sebum well because that may induce dry skin .
BACKGROUND	This concern may be caused by the result that cleansers with a high cleansing ability tend to decrease not only facial sebum but also natural moisturizing factors and intercellular lipids that are essential for cutaneous function .
BACKGROUND	Recently , we have developed a new cleanser based on sodium laureth carboxylate and alkyl carboxylates ( AEC/soap ) that cleans sebum well without penetrating the stratum corneum .
OBJECTIVE	This trial was aim to clarify the effects of sebum removal by AEC/soap-based cleanser on the induction of dry skin .
METHODS	We designed a controlled single blind parallel trial .
METHODS	Thirty female subjects with mild dry skin were assigned randomly to two groups : one group used AEC/soap-based cleanser while the other group kept using their usual facial cleanser twice a day for 4weeks in the winter season .
RESULTS	Using a colored artificial sebum mixture , it was demonstrated that this cleanser washed sebum well .
RESULTS	Following usage of this cleanser , their dry skin improved rather than worsen which was indicated by instrumental analysis and visual assessment .
RESULTS	These improvements were recognized by subjects .
CONCLUSIONS	These results suggest that AEC/soap-based cleanser washes off facial sebum well , but it has little effect on the induction of dry skin because of less penetration into stratum corneum .

###16513301
OBJECTIVE	To evaluate the effects of a non-prescription red clover extract ( MF11 RCE , Melbrosin International , Vienna , Austria ) on selected sex hormones and endometrium in postmenopausal women .
METHODS	One-hundred and nine postmenopausal women with an age > or = 40 years were randomly assigned to one of two groups either two capsules of MF11RCE ( 80mg isoflavone ) per day for a 90 day period , or placebo of equal design .
METHODS	After a 7 day washout period , medication was crossed-over for another 90 days .
RESULTS	Combined evaluation demonstrated that supplementation with MF11RCE ( verum ) , in contrast to placebo , significantly increased plasma testosterone levels and decreased endometrial thickness .
CONCLUSIONS	MF11RCE exerts a moderate effect on testosterone levels in postmenopausal women , while estradiol levels remained unchanged .
CONCLUSIONS	The observed reduction of endometrial thickness provides further support for a safe role for isoflavones in terms of endometrial hyperplasia .

###23551886
BACKGROUND	Sexual dysfunction , particularly erectile dysfunction ( ED ) , is common in men with type 2 diabetes , occurring in up to 75 % of cases .
BACKGROUND	The prevalence of hypogonadism is also high in men with diabetes and low testosterone is associated with both sexual dysfunction and a reduced response to oral therapy for ED .
OBJECTIVE	This study aimed to determine the effect of testosterone replacement with long-acting Testosterone Undecanoate ( TU ) on sexual function , mood and quality of life vs. placebo over a treatment period of 30 weeks followed by 52 weeks of open-label medication .
OBJECTIVE	The study was conducted in a primary care population of men with type 2 diabetes attending their primary care physician for routine visits .
METHODS	The male diabetic populations of seven general practices were screened at routine diabetes visits to detect symptomatic men with total testosterone levels of 12 nmol/L or less or with free testosterones of 250 pmol/L or less .
METHODS	Two hundred eleven men were screened .
METHODS	A double-blind placebo-controlled study was conducted in 199 men with type 2 diabetes and hypogonadism treated for 30 weeks with either 1,000 mg of TU or matching placebo followed by 52-week open-label follow on .
METHODS	The primary outcome measure , International Index of Erectile Function ( IIEF ) , was used to evaluate sexual dysfunction , and the Ageing Male Symptom ( AMS ) , Hospital Anxiety and Depression Scale , and Global Efficacy Question were used as secondary outcome measures to assess mood and self-reported quality of life .
RESULTS	Testosterone replacement therapy with long-acting TU improved all domains of sexual function at 30 weeks ( erectile function [ EF ] , P = 0.005 ; intercourse satisfaction , P = 0.015 ; sexual desire , P = 0.001 ; overall satisfaction , P = 0.05 ; and orgasm , P = 0.04 ) , with benefit as early as 6 weeks .
RESULTS	Improvements in AMS score were significant in men without depression ( P = 0.02 ) and the presence of depression at baseline was associated with marked reduction in response to both sexual function and psychological scores .
RESULTS	All responses in sexual function continued to improve significantly up to 18 months with an improvement in EF score of 4.31 from baseline .
RESULTS	In a small cohort of 35 men taking phosphodiesterase type 5 inhibitors , there was no change during the double-blind phase but a nine-point improvement in EF domain during 52-week open-label treatment .
RESULTS	After 30 weeks , 46 % vs. 17 % of patients on active therapy vs. placebo felt that the treatment had improved their health , reaching 70 % after open-label therapy .
RESULTS	Less obese and older patients responded better to testosterone therapy .
RESULTS	There were no significant adverse events .
CONCLUSIONS	TU significantly improved all domains of the IIEF and patient reported quality of life at 30 weeks and more significantly after 52-week open-label extension .
CONCLUSIONS	Improvement was most marked in less obese patient and those without coexisting depression .
CONCLUSIONS	In men with type 2 diabetes , trials of therapy may need to be given for much longer than 3-6 months suggested in current guidelines .

###21741309
BACKGROUND	Dignity therapy is a unique , individualised , short-term psychotherapy that was developed for patients ( and their families ) living with life-threatening or life-limiting illness .
BACKGROUND	We investigated whether dignity therapy could mitigate distress or bolster the experience in patients nearing the end of their lives .
METHODS	Patients ( aged 18 years ) with a terminal prognosis ( life expectancy 6 months ) who were receiving palliative care in a hospital or community setting ( hospice or home ) in Canada , USA , and Australia were randomly assigned to dignity therapy , client-centred care , or standard palliative care in a 1:1:1 ratio .
METHODS	Randomisation was by use of a computer-generated table of random numbers in blocks of 30 .
METHODS	Allocation concealment was by use of opaque sealed envelopes .
METHODS	The primary outcomes -- reductions in various dimensions of distress before and after completion of the study -- were measured with the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale , Patient Dignity Inventory , Hospital Anxiety and Depression Scale , items from the Structured Interview for Symptoms and Concerns , Quality of Life Scale , and modified Edmonton Symptom Assessment Scale .
METHODS	Secondary outcomes of self-reported end-of-life experiences were assessed in a survey that was undertaken after the completion of the study .
METHODS	Outcomes were assessed by research staff with whom the participant had no previous contact to avoid any possible response bias or contamination .
METHODS	Analyses were done on all patients with available data at baseline and at the end of the study intervention .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00133965 .
RESULTS	165 of 441 patients were assigned to dignity therapy , 140 standard palliative care , and 136 client-centred care .
RESULTS	108 , 111 , and 107 patients , respectively , were analysed .
RESULTS	No significant differences were noted in the distress levels before and after completion of the study in the three groups .
RESULTS	For the secondary outcomes , patients reported that dignity therapy was significantly more likely than the other two interventions to have been helpful ( ( 2 ) = 3550 , df = 2 ; p < 00001 ) , improve quality of life ( ( 2 ) = 1452 ; p = 0001 ) , increase sense of dignity ( ( 2 ) = 1266 ; p = 0002 ) , change how their family saw and appreciated them ( ( 2 ) = 3381 ; p < 00001 ) , and be helpful to their family ( ( 2 ) = 3386 ; p < 00001 ) .
RESULTS	Dignity therapy was significantly better than client-centred care in improving spiritual wellbeing ( ( 2 ) = 1035 ; p = 0006 ) , and was significantly better than standard palliative care in terms of lessening sadness or depression ( ( 2 ) = 938 ; p = 0009 ) ; significantly more patients who had received dignity therapy reported that the study group had been satisfactory , compared with those who received standard palliative care ( ( 2 ) = 2958 ; p < 00001 ) .
CONCLUSIONS	Although the ability of dignity therapy to mitigate outright distress , such as depression , desire for death or suicidality , has yet to be proven , its benefits in terms of self-reported end-of-life experiences support its clinical application for patients nearing death .
BACKGROUND	National Cancer Institute , National Institutes of Health .

###15050334
OBJECTIVE	Previous studies have demonstrated that urinary 8-iso-prostaglandin F ( PGF ) 2alpha serves as a powerful biomarker of lipid peroxidation in diseases in which oxidative stress plays an important role in its pathophysiology .
OBJECTIVE	The goal of this study was to measure the urinary isoprostane levels in patients with prostate cancer treated with radiotherapy ( RT ) in an effort to determine whether isoprostane levels are elevated compared with in historical controls , whether the levels increase after RT , and whether such an increase would correlate positively with the degree of GU symptoms during treatment .
METHODS	Urine samples were obtained before and during RT from patients enrolled on a recently reported Phase III trial examining the therapeutic efficacy of ibuprofen in decreasing the acute urinary symptoms of RT. .
METHODS	Radioimmunoassays were performed on urine samples for 8-iso-PGF2alpha or 15-keto-dihydro-PGF2alpha .
RESULTS	Fifteen patients provided samples both before and during RT. .
RESULTS	The levels of 8-iso-PGF ( 2alpha ) and 15-keto-dihydro-PGF2alpha in the urine samples obtained before prostate RT ( 0.27 and 0.41 nmol/mmol creatinine ) did not differ appreciably from the values observed in a normal cohort ( 0.27 and 0.46 nmol/mmol creatinine ) and did not change after RT ( 0.23 and 0.37 nmol/mmol creatinine ) .
CONCLUSIONS	We were unable to detect an increase in either 8-iso-PGF2alpha or 15-keto-dihydro-PGF2alpha in the urine of patients with prostate cancer compared with in historical normal controls .
CONCLUSIONS	We were also unable to measure an increase in either of the eicosanoids during RT to the prostate gland .

###17848493
BACKGROUND	The MEGA study is a randomized controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against coronary heart disease ( CHD ) , in which 8214 subjects are randomized to diet or diet plus pravastatin .
BACKGROUND	Pravastatin reduces the incidence of CHD ( hazard ratio = 0.67 ; 95 % CI : 0.49-0 .91 ) .
BACKGROUND	In the MEGA study , in addition to the usual loss to follow-up cases , there is another problem of drop-outs due to the refusal of further follow-up at 5 years .
OBJECTIVE	To estimate the treatment effect adjusting for some types of dependent censorings observed in the MEGA study and to assess the sensitivity of standard analysis results for these censoring cases .
METHODS	The proposed method is a straightforward extension of the inverse probability of censoring weighted ( IPCW ) method for settings with more than one reason for censoring , where the propensities for drop-outs are modeled separately for each reason .
METHODS	Simulation studies are also conducted to compare the properties of the IPCW estimate with the standard analysis assuming independent censorings .
RESULTS	Simulation studies show that the IPCW estimate can correct for selection bias due to dependent censoring that can be explained by measured factors , while the standard analysis is biased .
RESULTS	Applying the proposed method to the MEGA study data , several prognostic factors are associated with the censoring processes , and after adjusting for these dependent censorings , slightly larger treatment effects for pravastatin are observed for both CHD ( primary endpoint ) and stroke ( secondary endpoint ) events .
CONCLUSIONS	The method developed is based on the fundamental assumption of sequentially ignorable censoring .
CONCLUSIONS	Our proposed method provides a valuable approach for estimating treatment effect adjusting for several types of dependent censorings .
CONCLUSIONS	Dependent censorings observed in the MEGA study did not cause a severe selection bias attributable to the covariates and the results from the standard analysis were robust in relation to the censorings .

###11109752
OBJECTIVE	To investigate the use of Laryngeal Mask Airway ( LMA ) and its comparison with the endotracheal tube for positive pressure ventilation .
METHODS	A tertiary care teaching hospital .
METHODS	Fifty adult ASA I and II patients undergoing peripheral limb surgery were randomly allocated to 2 groups for LMA or endotracheal tube insertion .
METHODS	A standardized anaesthetic technique was used .
METHODS	The groups were then compared regarding haemodynamic changes on insertion as well as removal of LMA and ETT and any complications that occurred were noted .
RESULTS	The haemodynamic response to insertion was significantly attenuated ( p < 0.05 ) in LMA group as compared to ETT group .
RESULTS	The cardiovascular response to extubation was not significantly different between the groups .
RESULTS	A higher incidence of coughing and mild hypoxaemia at extubation was noted in ETT group as compared to LMA group ( p < 0.05 ) and blood was detected in 4 cases after LMA removal .
CONCLUSIONS	It is concluded that the use of LMA during positive pressure ventilation is safe in selected cases .
CONCLUSIONS	There is an attenuated haemodynamic response to insertion of LMA as compared to endotracheal tube which will be beneficial in certain patients e.g. , those with ischaemic heart disease , vascular disease and hypertensives .

###16264062
BACKGROUND	The chronobiology of asthma suggests that , for once-daily dosing , an evening dose may be the most effective treatment paradigm .
OBJECTIVE	To evaluate the efficacy and safety of mometasone furoate dry powder inhaler ( MF-DPI ) administered once daily in the evening or twice daily in patients with asthma previously maintained on twice-daily regimens of inhaled corticosteroids .
METHODS	In this 12-week , multicenter , placebo-controlled trial , 268 subjects > or = 12 years of age with inhaled corticosteroid-dependent asthma and baseline forced expiratory volume in 1 second ( FEV ( 1 ) ) between 50 % and 85 % of predicted were randomized to receive treatment with MF-DPI 400 mug once daily in the evening , MF-DPI 200 mug twice daily , or placebo .
METHODS	The primary efficacy variable was mean change in FEV ( 1 ) from baseline to endpoint .
METHODS	Other lung function measures , asthma symptoms , quality of life , and rescue medication use also were assessed .
RESULTS	At endpoint , mean FEV ( 1 ) was significantly improved with both MF-DPI doses compared with placebo ( p < 0.001 ) .
RESULTS	The 2 active treatment groups were statistically indistinguishable from each other .
RESULTS	Secondary efficacy variables , including nocturnal awakenings , asthma worsenings , quality of life , and rescue medication use , were also significantly improved for both MF-DPI treatments compared with placebo .
RESULTS	Both dosages were well tolerated ; no clinically meaningful changes in laboratory values or vital signs were observed .
CONCLUSIONS	MF-DPI 400 mug once daily in the evening was as effective as MF-DPI 200 mug twice daily in improving pulmonary function , asthma symptoms , and quality of life compared with placebo in subjects previously using twice-daily regimens of an inhaled corticosteroid .

###10960201
OBJECTIVE	To evaluate the effects of adding low concentration of fentanyl to 0.2 % ropivacaine when providing patient-controlled epidural analgesia ( PCEA ) outside the Post-Anesthesia Care Unit .
METHODS	Prospective , randomized , double-blind study .
METHODS	Inpatients at a University Department of Anesthesia .
METHODS	32 ASA physical status I , II , and III patients , who were scheduled for elective major abdominal surgery , including bowel resection , hepatic resection , and pancreaticoduodenectomy .
METHODS	Patients received standard general/epidural anesthesia .
METHODS	After surgery patients were randomly allocated in a double-blind fashion to receive PCEA with either 0.2 % ropivacaine ( n = 16 ) or 0.2 % ropivacaine/2 microg/mL fentanyl ( n = 16 ) [ background infusion ranging between 4 and 6 mL/hr , with 1.5-mL incremental doses and a 20-min lock-out time ] .
METHODS	Dynamic pain during coughing , sedation , pulse oxymetry , hemodynamic variables , and motor block were evaluated at 1 , 6 , 12 , 24 , and 48 hours after the end of surgery by a blinded observer .
METHODS	Occurrence of untoward events , including nausea , vomiting , pruritus , need for supplemental oxygen ( for SpO ( 2 ) < 90 % ) , and respiratory complications , as well as total consumption of PCEA solution and incremental doses given to the patient were also recorded .
RESULTS	No differences in pain relief , motor block , degree of sedation , recovery of gastrointestinal motility , and other side effects were observed between the two groups .
RESULTS	Patients receiving 0.2 % ropivacaine alone requested far more incremental doses ( 23 doses [ 0-60 ] vs. 5 doses [ 0-25 ] ) ( p = 0.006 ) and needed far more analgesic solution ( 230 mL [ 140-282 ] vs. 204 [ 130-228 ] ) ( p = 0.003 ) than patients receiving the ropivacaine/fentanyl mixture .
RESULTS	Peripheral oxygen saturation was lower at 12 , 24 , and 48 hours during ropivacaine/fentanyl infusion than in patients receiving ropivacaine alone ( 12 h : 91 % + / - 2 % vs. 95 % + / - 2 % , p < 0.006 ; 24 h : 93 % + / - 1 % vs. 96 % + / - 2 % , p = 0.003 ; 48 h : 92 % + / - 1.8 % vs. 96 % + / - 1 % , p = 0.004 ) .
CONCLUSIONS	A thoracic epidural infusion of 0.2 % ropivacaine , with or without fentanyl , provided effective pain relief in most patients with a very low degree of motor blockade .
CONCLUSIONS	Adding 2 microg/ml fentanyl to 0.2 % ropivacaine reduced total consumption of local anesthetic solution and need for incremental doses , but did not provide clinically relevant advantages in quality of pain relief and incidence of motor block , leading to a significant decrease in peripheral SpO ( 2 ) , lasting up to 48 hours after surgery .

###9131946
OBJECTIVE	To investigate the pharmacokinetics of the enantiomers of flurbiprofen and inhibition of prostanoid production in blister fluid and serum .
METHODS	Eleven healthy volunteers received 75 mg R - , 75 mg S-flurbiprofen or no medication in a randomized 3-way cross-over study .
METHODS	Flurbiprofen concentrations were determined by h.p.l.c. TXB2 and PGE2 were determined by enzyme immunoassay and chemiluminescence immunoassay respectively .
RESULTS	S-flurbiprofen produced almost complete ( > 99 % vs baseline ) inhibition of thromboxane B2 ( TXB2 ) in serum in all volunteers and significant inhibition of prostaglandin E2 ( PGE2 ) generation in blister fluid , but there was a considerable inter-individual variation in the response ranging from -78 to +190 % change from control PGE2 AUC .
RESULTS	After administration of R-flurbiprofen , there was a mean maximum TXB2 inhibition of 65.2 + / - 15.0 % in serum but no significant changes of PGE2 levels in blister fluid were observed .
RESULTS	The pharmacokinetic parameters in serum and blister fluid were not significantly different between enantiomers .
RESULTS	R - to S-inversion did not occur to a clinically relevant extent .
RESULTS	For R-flurbiprofen , the complex rate constant of transfer into blister fluid was greater at the u.v.-exposed site ( 0.110 + / - 0.050 ) than at the control site ( 0.079 + / - 0.026 , P < 0.05 ) which corresponded to a higher AUC and Cmax of R-flurbiprofen in u.v.-exposed blister as compared with control .
RESULTS	For inhibition of TXB2 generation after administration of S-flurbiprofen , a sigmoidal log-linear concentration-response relationship was established in all subjects ( EC50 : 0.123 + / - 0.092 microgram ml-1 ) .
RESULTS	In contrast , inhibition of PGE2 production in blister showed no clear concentration-response relationship when correlated with concentrations of S-flurbiprofen in either serum or blister fluid .
RESULTS	After administration of R-flurbiprofen , no concentration-effect relationship could be established .
CONCLUSIONS	It is concluded that the blister model may have value for studying the pharmacokinetics and pharmacodynamics of antiinflammatory drugs in humans .
CONCLUSIONS	Interestingly , inter-individual variation in the pharmacokinetics of flurbiprofen enantiomers could not account for the variability in response observed in the blister model .

###2507061
OBJECTIVE	To assess whether inhibition of angiotensin converting enzyme protects kidney function in diabetic nephropathy .
METHODS	Open , randomised follow up study of normotensive insulin dependent diabetics with nephropathy either treated or not with captopril for one year .
METHODS	Outpatient diabetic clinic in a tertiary referral centre .
METHODS	32 Normotensive patients with insulin dependent diabetes complicated by nephropathy who were randomised either to the treatment group ( n = 15 ) or to the control group ( n = 17 ) .
METHODS	The treatment group was given captopril ( 25-100 mg/day ) for 12 months , the average dose during the second six months of the study being 40 mg daily .
METHODS	Controls were not treated .
METHODS	Albuminuria , arterial blood pressure , and the glomerular filtration rate .
RESULTS	Mean arterial blood pressure fell by 3 ( SE 2 ) mm Hg in the captopril treated group and rose by 6 ( 1 ) mm Hg in the controls .
RESULTS	In addition , albuminuria declined by 11 % in the captopril treated group and rose by 55 % in the controls , fractional albumin clearance fell by 17 % in the captopril treated group and increased by 66 % in the controls , and the glomerular filtration rate declined by 3.1 ( 2.8 ) ml/min/1 .73 m2 with captopril and by 6.4 ( 3.1 ) ml/min/1 .73 m2 in the controls .
CONCLUSIONS	Inhibition of angiotensin converting enzyme arrests the progressive rise in albuminuria in normotensive insulin dependent diabetics with nephropathy .

###8166152
OBJECTIVE	To study whether oral ciprofloxacin would be as effective in preventing bacterial infections in severely myelosuppressed patients as selective antibiotic modulation of the gut flora with neomycin/polymyxin B sulfate/nalidixic acid ( NPN ) .
METHODS	One hundred and five patients undergoing allogeneic or autologous bone marrow transplant , or induction therapy for acute leukemia in 1988 and 1989 were studied .
METHODS	Patients were stratified according to the type of therapy , and randomized in a ratio of 2:1 to either oral ciprofloxacin 500 mg BID , or a combination of oral neomycin 250 mg QID , polymyxin-B 100 mg QID , and oral nalidixic acid 1,000 mg BID .
METHODS	Treatment began on admission and continued until the absolute granulocyte count was greater than 500/mm3 for 3 consecutive days .
RESULTS	The 96 evaluable patients were evenly distributed over the 3 treatment groups ; 63 patients received ciprofloxacin and 33 received NPN .
RESULTS	Fever developed in 92 % of patients on ciprofloxacin and in 97 % of patients on NPN .
RESULTS	( P = 0.66 ) , 6.6 + / - 5.8 and 7.2 + / - 5.3 days from the start of prophylaxis , respectively .
RESULTS	Twenty-five patients on ciprofloxacin developed 29 microbiologically documented infections , fewer than the 26 infections in the 22 patients on NPN ( P = 0.02 ) .
RESULTS	Patients on ciprofloxacin had fewer bacteremias ( 33 % ) than did the NPN patients ( 55 % ) ( P = 0.05 ) .
RESULTS	Gram-negative bacteremias were very rare ( 2 cases ; no Enterobacteriaceae ) , but streptococcal bacteremias were frequent in both arms ( 27 cases ) .
RESULTS	Side effects were not significantly different , but compliance with ciprofloxacin was better .
CONCLUSIONS	Ciprofloxacin is at least as effective as the combination of neomycin/polymyxin/nalidixic acid in the prophylaxis of bacterial infections in myelosuppressed patients , and is better tolerated .
CONCLUSIONS	Additional agents to prevent streptococcal infections are needed .

###19922618
BACKGROUND	A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use .
BACKGROUND	However , although alcohol misuse is common amongst offenders , there is limited evidence of alcohol brief interventions in the criminal justice field .
BACKGROUND	This factorial pragmatic cluster randomised controlled trial with Offender Managers ( OMs ) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients .
METHODS	Ninety-six OMs from 9 probation areas across 3 English regions ( the North East Region ( n = 4 ) and London and the South East Regions ( n = 5 ) ) will be recruited .
METHODS	OMs will be randomly allocated to one of three intervention conditions : a client information leaflet control condition ( n = 32 OMs ) ; 5-minute simple structured advice ( n = 32 OMs ) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker ( n = 32 OMs ) .
METHODS	Randomisation will be stratified by probation area .
METHODS	To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire ( M-SASQ ) or the Fast Alcohol Screening Test ( FAST ) .
METHODS	There will be a minimum of 480 clients recruited into the trial .
METHODS	There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention .
METHODS	Analysis will include client measures ( screening result , weekly alcohol consumption , alcohol-related problems , re-offending , public service use and quality of life ) and implementation measures from OMs ( the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention ) .
METHODS	We will also examine the practitioner and organisational factors associated with successful implementation .
CONCLUSIONS	The trial will evaluate the impact of screening and brief alcohol intervention in routine probation work and therefore its findings will be highly relevant to probation teams and thus the criminal justice system in the UK.Ethical approval was given by Northern & Yorkshire REC .
BACKGROUND	ISRCTN 19160244 .

###17012720
BACKGROUND	The authors compared the in vivo antimicrobial effects on microorganisms from dental plaque , saliva and the tongue in subjects who used a triclosan/copolymer dentifrice and a fluoride dentifrice ( control ) .
METHODS	The authors assigned 15 subjects randomly to the control dentifrice or the triclosan/copolymer dentifrice for twice-daily use for one week .
METHODS	They collected samples of plaque , saliva and tongue scrapings six and 12 hours after the final brushing .
METHODS	They analyzed colony-forming units of Veillonella species , Fusobacteria species , total cultivable anaerobes and hydrogen sulfide ( H ( 2 ) S ) - producing bacteria .
METHODS	A one-week washout followed .
METHODS	The authors repeated the protocol with the second dentifrice .
RESULTS	The results showed no differences at baseline .
RESULTS	Significant reductions ( 88 to 96 percent ) in oral anaerobic bacteria were observed in the triclosan/copolymer group six and 12 hours after brushing compared with the control group ( P = .001 ) .
RESULTS	Fusobacteria decreased by 77 to 92 percent and Veillonella decreased by 84 to 89 percent six and 12 hours after brushing in the triclosan/copolymer group versus the control group .
RESULTS	The triclosan/copolymer group also demonstrated a significant decrease in H ( 2 ) S-producing bacteria six and 12 hours after brushing ( 74 to 85 percent ) ( P = .001 ) .
CONCLUSIONS	Brushing with the triclosan/copolymer dentifrice resulted in significant reductions in microorganisms from the three sites compared with the control dentifrice .
CONCLUSIONS	The triclosan/copolymer dentifrice produced sustained effects on oral bacteria for 12 hours .

###15898938
BACKGROUND	Demineralized bone matrix ( DBX ) paste and putty are particulate demineralized bone matrices in a 2 % or 4 % hyaluronate carrier , respectively .
BACKGROUND	The purpose of this study was to determine the effectiveness of DBX paste and putty compared to demineralized freeze-dried bone allograft ( DFDBA ) in the treatment of human intraosseous periodontal defects .
METHODS	Sixty systemically healthy individuals between the ages of 31 and 71 years with at least one intraosseous periodontal defect of > or = 3 mm in depth and radiographic evidence of at least 40 % to 50 % vertical bone loss were accrued .
METHODS	Following initial non-surgical periodontal therapy , sites were randomly selected to receive either DBX paste , DBX putty , or DFDBA ( control ) .
METHODS	Baseline and 6-month reentry soft and hard tissue parameter measurements were made by calibrated examiners .
METHODS	Data were analyzed within and between groups utilizing analysis of variance ( ANOVA ) and paired and unpaired Student t tests .
RESULTS	Probing depth reductions were significantly improved in all treatment groups with DFDBA , DBX paste , and putty patients demonstrating 2.8 mm , 3.6 mm , and 2.3 mm , respectively .
RESULTS	Attachment level gains were significantly improved from baseline for all treatment groups with DFDBA , DBX paste , and putty , respectively , demonstrating 2.4 mm , 2.9 mm , and 1.6 mm .
RESULTS	Bone fill was similar between all groups with DBX paste , putty , and DFDBA control groups demonstrating 2.0 mm , 2.4 mm , and 2.2 mm , respectively .
RESULTS	All groups yielded significant improvements in percent bone fill with DFDBA , DBX paste and putty , respectively , achieving 37 % , 42.1 % , and 50 % with no significant differences between the groups .
CONCLUSIONS	In summary , demineralized bone matrix paste , demineralized bone matrix putty , and demineralized freeze-dried bone allograft all demonstrated similar favorable improvements in soft and hard tissue parameters in the treatment of human intraosseous defects .

###22588154
BACKGROUND	The objective of this study is to report the impact of computed tomography ( CT ) screening on the use of Video-Assisted Thoracic Surgery ( VATS ) in a randomized screening trial .
METHODS	The Danish Lung Cancer Screening Trial is a randomized clinically controlled trial of 4104 smokers and previous smokers who were randomized to either screening with five annual low-dose CT scans or no screening in Copenhagen from 2004 to 2006 .
METHODS	The major end point is the effect of CT screening on lung cancer mortality and treatment options .
METHODS	All diagnostic and treatment interventions in both groups were monitored prospectively until 1 to 3 years after the last screening round .
RESULTS	By February 1 , 2011 68 cases of lung cancer were detected in the screening group .
RESULTS	Furthermore , seven patients with a benign nodule underwent surgical treatment because of suspicion of malignancy ( 12 % ) .
RESULTS	Fifty-one of the 68 lung cancer patients were eligible for surgical treatment .
RESULTS	Eight patients had open thoracotomy .
RESULTS	Of the operations for lung cancer , 84 % were performed by VATS in the CT-screened arm , significantly higher than the control arm ( p < 0.05 ) .
RESULTS	Thirty-six patients had a VATS lobectomy .
RESULTS	One patient had a VATS segmentectomy , and four patients had a VATS wedge resection .
RESULTS	The seven benign nodules were all treated with VATS .
CONCLUSIONS	CT screening seems to facilitate the use of VATS in the treatment of lung cancer with an 84 % rate in our data .
CONCLUSIONS	Furthermore , all benign nodules could be removed by VATS .
CONCLUSIONS	In our view , a basic requirement for a surgical institution to be involved in lung cancer CT screening is a dedicated VATS program .

###23707115
OBJECTIVE	- amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor ( AMPAR ) peptide , a product of the proteolytic degradation of AMPA receptors in healthy nonathletes and athletes with concussions , is assessed .
OBJECTIVE	The detection of AMPAR peptide in conjunction with neuropsychological testing and neuroimaging is undertaken .
METHODS	Persons ( n = 124 , 19-23 years ) are enrolled in the pilot-blinded study according to approved Institutional Review Board protocols at Kennesaw State University and DeKalb Medical .
METHODS	AMPAR peptide plasma assay was performed using magnetic particles-enzyme-linked immunosorbent assay .
METHODS	All participants had neurocognitive tests ( ImPACT ) ; selected subjects with concussions were followed-up with magnetic resonance imaging and neurologic consultations .
RESULTS	Athletes ( n = 33 ) with clinically defined single or multiple concussions were compared to 91 age and gender matched controls without a history of concussion .
RESULTS	AMPAR peptide values of 0.05-0 .40 ng/mL for controls and 1.0-8 .5 ng/mL for concussions are found .
RESULTS	The biomarker sensitivity of 91 % and a specificity of 92 % ( 0.4 ng/mL cut off ) to assess concussions are calculated .
RESULTS	Poorer ImPACT scores correlated with abnormal levels of the biomarker .
RESULTS	In athletes with multiple concussions , increased AMPAR peptide values ( 2.0-12 .0 ng/mL ) were associated with minor findings on magnetic resonance imaging .
CONCLUSIONS	AMPAR peptide assay combined with ImPACT and neuroimaging is a promising tool for assessment of concussions .
CONCLUSIONS	Additional clinical validation studies are required .

###12952496
OBJECTIVE	To evaluate the safety , tolerability , pharmacokinetics and pharmacodynamics of BIA 2-093 [ S - ( - ) -10 - acetoxy-10 ,11 - dihydro-5H-dibenzo / b , f/aze - pine-5-carboxamide ] in healthy male volunteers .
METHODS	This was a double-blind , randomised , placebo-controlled , single ascending dose study performed with BIA 2-093 , a new putative antiepileptic drug .
METHODS	Groups of eight healthy male subjects ( two randomised to receive placebo and the remaining six to receive BIA 2-093 ) received single oral doses of BIA 2-093 of 20 , 50 , 100 , 200 , 400 , 600 , 900 and 1200 mg .
METHODS	A total of 64 healthy male volunteers aged 18-35 years participated in the study .
RESULTS	The incidence of adverse events , which were mild in severity , was similar between all treatment groups , including the placebo group .
RESULTS	There were no serious adverse events during this study .
RESULTS	No clinically significant abnormalities in laboratory safety tests , vital signs , weight , physical examination or ECG were reported .
RESULTS	BIA 2-093 appeared to be rapidly and extensively metabolised to BIA 2-005 [ RS ( + / - ) -10,11 - dihydro-10-hydroxy-5H-dibenzo / b , f/azepine -5 - carboxamide ] , the major metabolite , and oxcarbazepine ( the minor metabolite ) , following single oral doses of BIA 2-093 of 20-1200 mg .
RESULTS	Plasma BIA 2-093 concentrations were generally below the limit of quantification of the assay .
RESULTS	Maximum plasma concentrations ( C ( max ) ) of BIA 2-005 and oxcarbazepine were reached , respectively , at 0.75-4h and 6h postdose , after which they declined with an approximate mean apparent terminal half-life of 8-17h and 7-12h , respectively .
RESULTS	The increase in systemic exposure to BIA 2-005 was approximately proportional to the administered dose for C ( max ) and greater than dose proportional for the area under the concentration-time curve .
RESULTS	Renal clearance of BIA 2-005 ( 20 mL/min ) appeared to be constant over the dose range studied , indicating that the dose-dependent urinary recovery was due either to increased formation of BIA 2-005 with increasing dose level or to decreased non-renal elimination of the metabolite .
CONCLUSIONS	BIA 2-093 undergoes extensive metabolism to BIA 2-005 and was well tolerated at oral doses of 20-1200 mg.The results provide a basis for further clinical trials with BIA 2-093 .

###21853269
OBJECTIVE	The purpose of this study is to quantify the interspinous anatomy at the L4/5 and L5/S1 levels .
METHODS	One hundred reconstructed computer tomography scans of the lumbosacral spine were reviewed by two separate surgeons .
METHODS	Data were collected from the midline sagittal reconstructed image at the L4-5 and L5-S1 levels .
METHODS	Measurements obtained included the disc angle , anterior and posterior disc height , and maximum interspinous space in both the anterior-posterior and cephalad-caudal directions .
METHODS	The disc height and disc angle were correlated with the interspinous height .
RESULTS	The mean age of the patients reviewed was 47years ( range : 16-91 ; standard deviation : 20 ) .
RESULTS	According to our data population , the average length of the interspinous space was larger at the L4-5 level ( 13mm ) than the L5-S1 level ( 9mm ) .
RESULTS	The interspinous height was similar between the two levels .
RESULTS	A poor correlation existed between the disc height or disc angle and the interspinous height .
RESULTS	There was no correlation between measurements and age .
CONCLUSIONS	The interspinous space available , as defined by computer tomography , at the L5/S1 level , is less able to accommodate current interspinous devices compared to the adjacent L4/5 level .
CONCLUSIONS	The limiting factor is the length of the sacral part of the L5-S1 interspinous space .

###21562320
OBJECTIVE	To examine the prevalence and incidence of unrecognized myocardial infarction in a contemporary population with type 2 diabetes .
METHODS	We performed a retrospective analysis of the electrocardiograms ( ECGs ) recorded at baseline and after 2 years for the first 1,004 type 2 diabetic individuals to be randomized in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes ( RECORD ) study .
RESULTS	ECGs suitable for analysis were obtained from 669 participants .
RESULTS	The prevalence of unrecognized Q-wave myocardial infarction at baseline was 1.9 % ( n = 13 ) .
RESULTS	The incidence of unrecognized Q-wave myocardial infarction at the end of 2 years of follow-up was 1.5 / 1,000-person-years ( n = 2 ) .
RESULTS	One-third ( 13 of 39 ) of prevalent and one-quarter ( 2 of 8 ) of incident myocardial infarctions were unrecognized .
CONCLUSIONS	Although the prevalence and incidence of myocardial infarction was low , unrecognized Q-wave myocardial infarctions made up a substantial proportion of all events .

###11313190
BACKGROUND	Prophylaxis efforts for the maintenance of tooth health led to a distinctive decrease in caries frequency with children and young persons .
BACKGROUND	Because the toothbrush can still be described as the most important oral hygiene aid , possible differences between the effectivity of electric and manual toothbrushes should be tested in the present study .
BACKGROUND	Elementary school children had been instructed -- within a special prophylaxis program -- over a period of three years to clean their teeth partly with electric partly with manual toothbrushes .
METHODS	In two parallel classes ( 1st class ) of the same elementary school ( Private Martinusschule Mainz-Gonsenheim ) the A-class ( n = 24 children ) was instructed to clean their teeth with a manual toothbrush suitable for children ( Oral-B , Power Tip , Braun AG , Kronberg , Germany ) whereas the B-class ( n = 26 ) received electric toothbrushes ( Oral-B-7 EB 5 K , Braun AG , Kronberg , Germany ) .
METHODS	Every three months the children were instructed in group-preventive methods in school , followed by cleaning instructions , remotivations and the distribution of new electric respectively manual toothbrushes .
METHODS	In order to record the influence of the intensive quarterly oral hygiene instruction , elementary school children ( 1st class ) of the same school type were looked after and examined within the yearly group prophylaxis ( n = 40 ) .
METHODS	The yearly dental examinations included the recording of carious frequency ( DMF-T , dmf-t ) , approximal plaque accumulation ( API ) , and the evaluation of the gingival state ( GI-Index ) as well as the present dental restorative materials .
RESULTS	After an investigation period of three years no essential differences regarding caries frequency , proportion of dentitions of natural state of health and plaque involvement were found with the children of the respective classes .
RESULTS	Children using electric toothbrushes showed after 3 years 27 % of healthy-natured dentitions on average ( 46 % of the children had got API-values of up to 30 % ) and the children who used manual toothbrushes showed 22 % of nature-healthy dentitions ( 52 % of the children had got API-values of up to 30 % ) and in 33 % of the control children who received instructions only once a year healthy-natured dentitions were found after 3 years ( 75 % of the children had got API-values of up to 35 % ) .
CONCLUSIONS	With regard to caries and gingivitis prevalence modern electric toothbrushes for children can be considered equally efficient like conventional manual toothbrushes for children with children of normal caries risk .

###17091415
BACKGROUND	This randomized controlled trial compared the diagnostic accuracy of the sonographic assessment of cervical length and clinical digital examination of the cervix in the second trimester regarding the prediction of preterm delivery in a low-risk population .
METHODS	In total , 282 unselected , asymptomatic women with singleton pregnancy randomly underwent sonographic cervical length measurement ( study group , n = 138 ) or clinical digital examination ( control group , n = 144 ) in the second trimester .
METHODS	In the study group cervical length < or = 5th percentile ( < or = 24 mm ) for our population was defined as shortened .
METHODS	In the control group , Bishop score > or = 95th percentile ( > or = 4 ) for our population was defined as high .
METHODS	The primary outcome measure was the diagnostic accuracy of both tests regarding the prediction of preterm delivery ( < 37 weeks ) .
RESULTS	Shortened cervical length was found in 6/138 ( 4.3 % ) women whereas the high Bishop score was found in 17/144 ( 11.8 % ) ( p = 0.038 , Fisher 's exact test ) .
RESULTS	The incidence of preterm delivery was 5.7 % ( 16/282 ) .
RESULTS	Regarding the prediction of preterm delivery , shortened cervical length and high Bishop score had sensitivity 57.1 % versus 33.3 % and positive predictive value 66.7 % versus 17.6 % .
RESULTS	Shortened cervical length in comparison with high Bishop score had 12-fold higher positive likelihood ratio for preterm delivery in a low-risk population ( 37.4 ; 95 % CI [ 8.2-170 .7 ] versus 3.2 ; 95 % CI [ 1.1-9 .2 ] ) .
CONCLUSIONS	Sonographic assessment of cervical length has better diagnostic accuracy in the prediction of preterm delivery compared to digital examination in a low-risk population .

###19857180
OBJECTIVE	In unstable distal radial fractures that are impossible to reduce or to maintain in reduced position , the treatment of choice is operation .
OBJECTIVE	The type of operation and the choice of implant , however , is a matter of discussion .
OBJECTIVE	Our aim was to investigate whether open reduction and internal fixation would produce a better result than traditional external fixation .
METHODS	50 patients with an unstable or comminute distal radius fracture were randomized to either closed reduction and bridging external fixation , or open reduction and internal fixation using the TriMed system .
METHODS	The primary outcome parameter was grip strength , but the patients were followed for 1 year with objective clinical assessment , subjective outcome using DASH , and radiographic examination .
RESULTS	At 1 year postoperatively , grip strength was 90 % ( SD 16 ) of the uninjured side in the internal fixation group and 78 % ( 17 ) in the external fixation group .
RESULTS	Pronation/supination was 150 degrees ( 15 ) in the internal fixation group and 136 degrees ( 20 ) in the external fixation group at 1 year .
RESULTS	There were no differences in DASH scores or in radiographic parameters .
RESULTS	5 patients in the external fixation group were reoperated due to malunion , as compared to 1 in the internal fixation group .
RESULTS	7 other cases were classified as radiographic malunion : 5 in the external fixation group and 2 in the internal fixation group .
CONCLUSIONS	Internal fixation gave better grip strength and a better range of motion at 1 year , and tended to have less malunions than external fixation .
CONCLUSIONS	No difference could be found regarding subjective outcome .

###11701101
OBJECTIVE	To test the hypotheses that : ( 1 ) Lumbar spine radiography in primary care patients with low back pain is not associated with improved patient outcomes , including pain , disability , health status , sickness absence , reassurance , and patient satisfaction or belief in the value of radiography .
OBJECTIVE	( 2 ) Lumbar spine radiography in primary care patients with low back pain is not associated with changes in patient management , including medication use , and the use of primary and secondary care services , physical therapies and complementary therapies .
OBJECTIVE	( 3 ) Participants choosing their treatment group ( i.e. radiography or no radiography ) do not have better outcomes than those randomised to a treatment group .
OBJECTIVE	( 4 ) Lumbar spine radiography is not cost-effective compared with usual care without lumbar spine radiography .
METHODS	A randomised unblinded controlled trial .
METHODS	Seventy-three general practices in Nottingham , North Nottinghamshire , Southern Derbyshire , North Lincolnshire and North Leicestershire .
METHODS	Fifty-two practices recruited participants to the trial .
METHODS	Randomised arm : 421 participants with low back pain , with median duration of 10 weeks .
METHODS	Patient preference arm : 55 participants with low back pain , with median duration of 11 weeks .
METHODS	Lumbar spine radiography and usual care versus usual care without radiography .
METHODS	Roland adaptation of the Sickness Impact Profile , visual analogue pain scale , health status scale , EuroQol , use of primary and secondary care services , and physical and complementary therapies , sickness absence , medication use , patient satisfaction , reassurance and belief in value of radiography at 3 and 9 months post-randomisation .
RESULTS	Participants randomised to receive an X-ray were more likely to report low back pain at 3 months ( odds ratio ( OR ) = 1.56 ; 95 % confidence interval ( CI ) , 1.02 to 2.40 ) and had a lower overall health status score ( p = 0.02 ) .
RESULTS	There were no differences in health or functional status at 9 months .
RESULTS	A higher proportion of participants consulted the general practitioner ( GP ) in the 3 months following an X-ray ( OR = 2.72 ; 95 % CI , 1.80 to 4.10 ) .
RESULTS	There were no differences in use of any other services , medication use or sickness absence at 3 or 9 months .
RESULTS	No serious spinal pathology was identified in either group .
RESULTS	The commonest X-ray reports were of discovertebral degeneration and normal findings .
RESULTS	Many patients did not perceive their information needs were met within the consultation .
RESULTS	Satisfaction with care was greater in the group receiving radiography at 9 months .
RESULTS	Participants randomised to receive an X-ray were not less worried , or more reassured about serious disease causing their low back pain .
RESULTS	Satisfaction was associated with meeting participants ' information needs and reduced belief in the necessity for investigations for low back pain , including X-rays and blood tests .
RESULTS	In both groups , at 3 and 9 months 80 % of participants would choose to have an X-ray if the choice was available .
RESULTS	Participants in the patient preference group achieved marginally better outcomes than those randomised to a treatment group , but the clinical significance of these differences is unclear .
RESULTS	Lumbar spine radiography was associated with a net economic loss at 3 and 9 months .
CONCLUSIONS	Lumbar spine radiography in primary care patients with low back pain of at least 6 weeks duration is not associated with improved functioning , severity of pain or overall health status , and is associated with an increase in GP workload .
CONCLUSIONS	Participants receiving X-rays are more satisfied with their care , but are not less worried or more reassured about serious disease causing their low back pain .
CONCLUSIONS	CONCLUSIONS - RECOMMENDATIONS FOR FURTHER RESEARCH : Further work is required to develop and test an educational package that educates patients and GPs about the utility of radiography and provides strategies for identifying and meeting the information needs of patients , and the needs of patients and GPs to be reassured about missing serious disease .
CONCLUSIONS	Guidelines on the management of low back pain in primary care should be consistent about not recommending lumbar spine radiography in patients with low back pain in the absence of red flags for serious spinal pathology , even if the pain has persisted for at least 6 weeks .

###22853325
BACKGROUND	Extended smoking cessation follow-up after hospital discharge significantly increases abstinence .
BACKGROUND	Hospital smoke-free policies create a period of ` forced abstinence ' for smokers , thus providing an opportunity to integrate tobacco dependence treatment , and to support post-discharge maintenance of hospital-acquired abstinence .
BACKGROUND	This study is funded by the National Heart , Lung , and Blood Institute ( 1U01HL1053231 ) .
METHODS	The Inpatient Technology-Supported Assisted Referral study is a multi-center , randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest ( KPNW ) and at Oregon Health & Science University ( OHSU ) hospitals in Portland , Oregon .
METHODS	The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition ( AR+IVR ) follow-up calls , compared to usual care inpatient counseling ( UC ) .
METHODS	In November 2011 , we began recruiting 900 hospital patients age 18 years who smoked 1 cigarettes in the past 30 days , willing to remain abstinent postdischarge , have a working phone , live within 50 miles of the hospital , speak English , and have no health-related barriers to participation .
METHODS	Each site will randomize 450 patients to AR+IVR or UC using a 2:1 assignment strategy .
METHODS	Participants in the AR+IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications , and four IVR follow-up calls over seven weeks postdischarge .
METHODS	Participants do not have to accept the referral .
METHODS	At KPNW , UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services .
METHODS	The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR+IVR participants compared to usual care .
METHODS	Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months , self-reported seven-day , thirty-day , and continuous abstinence at twelve months , intervention dose response at six and twelve months for AR+IVR recipients , incremental cost-effectiveness of AR+IVR intervention compared to usual care at six and twelve months , and health-care utilization and expenditures at twelve months for AR+IVR recipients compared to UC .
CONCLUSIONS	This study will provide important evidence for the effectiveness and cost-effectiveness of linking hospital-based tobacco treatment specialists ' services with discharge follow-up care .
BACKGROUND	ClinicalTrials.gov : NCT01236079 .

###21925746
BACKGROUND	Normotolerant subjects ( NGT ) are considered at low risk , even if a plasma glucose value 155 mg/dl for the 1-hour post-load plasma glucose during an oral glucose tolerance test ( OGTT ) is able to identify NGT at high-risk for type-2 diabetes and subclinical organ damage .
BACKGROUND	Insulin resistance ( IR ) contributes to the pathogenesis of impaired glucose tolerance and participates to the development of subclinical organ damage .
BACKGROUND	However , it is unknown whether NGT < 155 subjects are at low risk for the development of subclinical organ damage independently from other metabolic variables , such as IR/hyperinsulinemia .
METHODS	From a large cohort of about 1200 uncomplicated hypertensive outpatients underwent to OGTT , we selected 645 NGT subjects , 319 men and 326 women aged 47.6 10.6 .
METHODS	All subjects underwent standard echocardiography for measurement of left ventricular mass ( LVM ) , and carotid ultrasonography for evaluation of intima media thickness ( IMT ) .
METHODS	Finally , we estimated glomerular filtration rate ( e-GFR ) by using the new equation proposed by investigators in the chronic kidney disease epidemiology ( CKD-EPI ) collaboration .
RESULTS	NGT < 155 subjects into upper tertile of 1-h post-load insulin had a worse lipemic profile , a higher hs-CRP , creatinine , LVM , e-GFR and IMT .
RESULTS	Comparing the NGT groups , we observed that metabolic and hemodynamic parameters of NGT < 155 subjects into upper tertile of 1-h post-load insulin were similar to that observed in NGT 155 subjects .
RESULTS	Similarly , fasting and both 1-h and 2-h post-load insulin values were similar to that observed in NGT 155 .
CONCLUSIONS	We documented that hypertensive NGT subjects have different phenotypic patterns , particularly in their metabolic profile and in presence of subclinical organ damage .

###16025962
OBJECTIVE	To investigate the myocardial protective effect of puerarin injection ( PI ) in children with severe pneumonia .
METHODS	One hundred children with pneumonia enrolled were divided into two groups according to their condition of illness .
METHODS	Forty-eight children of mild condition in the common group ( CG ) were treated with conventional treatment and 52 children of serious condition in the severe group ( SG ) were treated with conventional treatment with additional PI or fructose-1 ,6 - disphosphate ( FDP ) for myocardial protection .
METHODS	The parameters of serum myocardial zymogram , ECG and cardiac blood flow were measured and the effects of PI and FDP in patients of serious condition were compared .
RESULTS	Change of serum myocardial zymographic parameters was indirectly proportional to the severity of childrens condition .
RESULTS	The reduction of myocardial contractive function was demonstrated by the change of cardiac blood flow parameters in Ultrasound Doppler examination ( P < 0.01 ) .
RESULTS	Both PI and FDP had the effect in protecting myocardium and improving heart function , showing insignificant difference between their efficacy ( P > 0.05 ) , but PI had less stimulation to vessels and without any obvious adverse reaction .
CONCLUSIONS	Severe pneumonia in children can lead to myocardial damage and heart failure , and early applying of myocardial protective measure can significantly improve the prognosis of patient .
CONCLUSIONS	Myocardial zymographic parameters , especially the CK-MB , are sensitive and important indexes for detecting myocardial injury .
CONCLUSIONS	PI has effects in protecting myocardium and improving heart function , and therefore , is suitable for spreading and applying in clinical practice .

###9777179
BACKGROUND	We sought to identify baseline predictors of response to clozapine .
METHODS	Data were from a 15-site randomized clinical trial comparing clozapine and haloperidol in hospitalized patients with refractory schizophrenia ( n = 423 ) .
METHODS	Three-month outcomes were analyzed with the full sample ( n = 368 due to attrition ) .
METHODS	Because of crossovers , analyses of 12-month outcomes were conducted with crossovers excluded ( n = 291 ) .
METHODS	Clinical predictors included age , race , diagnosis ( current substance abuse , paranoid subtype of schizophrenia , or depressive syndrome ) , severity of symptoms , quality of life , age at onset of schizophrenia , extrapyramidal symptoms , and VA compensation payment .
METHODS	Multiple regression analysis was used to examine the interaction of treatment condition and each of these variables in predicting outcomes for symptoms , quality of life , side effects , and days hospitalized .
RESULTS	Patients with higher quality of life at baseline ( p = .04 ) and higher symptoms ( p = .02 ) had relatively smaller declines in hospital days at 6 months .
RESULTS	In the 12-month sample patients with higher levels of symptoms had greater symptom reductions at 12 months ( p = .03 ) and greater improvement in quality of life ( p = .004 ) .
CONCLUSIONS	Although high levels of symptoms were associated with greater improvement on clozapine , these findings are not robust enough to suggest that any specific , clinically defined subgroup of refractory patients should be preferentially targeted for clozapine treatment .

###18324934
OBJECTIVE	Systematic reviews point to inconclusive evidence that counselling patients in a primary care setting is effective in increasing adults ' physical activity ( PA ) levels .
OBJECTIVE	This study evaluates the impact of an innovative physician counselling programme on physicians ' PA counselling behaviour and their patients ' PA levels .
METHODS	A controlled educational study conducted at six Yale School of Medicine hospitals .
METHODS	Sixty-five internal medicine residents and 316 primary care patients were randomized to intervention or control groups .
METHODS	Intervention physicians participated in five interactive sessions outlining details of the Pressure System Model , while control physicians received usual residency training .
METHODS	Intervention and control patients ' PA levels and residents counselling behaviour were assessed using a validated questionnaire and compared pre - and post intervention .
METHODS	Data analysis was performed using paired t-tests and repeated measures anova .
RESULTS	At 6-month follow-up intervention , patients ' PA levels increased significantly from baseline ( 1.77 + / - 0.84 ; P = 0.0376 ) .
RESULTS	A similar pattern was observed after 12 months ( 1.94 + / - 0.98 ; P = 0.0486 ) .
RESULTS	Control patients ' PA did not change significantly from baseline at 6 or 12 months ( 0.35 + / - 1.00 ; P = 0.7224 and 0.99 + / - 1.52 ; P = 0.5160 , respectively ) .
RESULTS	At 12 months , intervention residents provided PA counselling 1.5 times more than they did at baseline ( P < 0.05 ) compared with no significant changes in the control group .
CONCLUSIONS	The present study has shown that providing residents with a practical tool , enabling them to deal with patients ' barriers and previous failure in behavioural change , is efficacious in increasing PA levels of adult patients .

###9688105
OBJECTIVE	Because long-term weight reduction is often unsuccessful with dietary restriction alone , pharmacological agents have been used to promote weight loss .
OBJECTIVE	We have compared the novel ( multiple monoamine neurotransmitter reuptake inhibitor ) antiobesity drug sibutramine ( 10 mg once daily ) with the extensively studied serotonin-releasing antiobesity agent dexfenfluramine ( 15 mg twice daily ) .
METHODS	226 healthy outpatients ( aged 18 to 65 years ; body mass index > or = 27 kg/m2 ) were included in a 12-week , randomized , double-blind , parallel group study .
METHODS	The main outcome measures were changes in weight , body mass index , waist and hip circumference and ratio , and safety profiles .
RESULTS	Mean ( + / - SEM ) absolute weight loss was 4.5 + / - 0.4 kg in the sibutramine group ( n = 112 ) and 3.2 + / - 0.3 kg in the dexfenfluramine group ( n = 112 ) ( endpoint analysis ) ; 4.7 + / - 0.4 kg in the sibutramine group ( n = 101 ) ; and 3.6 + / - 0.3 kg in the dexfenfluramine group ( n = 94 ) ( completers analysis ) .
RESULTS	Comparing the two treatments under the conventional null hypothesis of equality as a secondary analysis , weight loss at endpoint in patients receiving sibutramine was significantly greater than that achieved with dexfenfluramine ( p < 0.05 ) .
RESULTS	Both drugs had similar adverse events profiles : 174 patients ( 77 % ) experienced adverse events ; 17 patients withdrew due to adverse events ( sibutramine , n = 6 ; dexfenfluramine , n = 11 ) .
RESULTS	Pulse rate increased significantly in sibutramine-treated patients ( 3.6 bpm ) , but decreased in dexfenfluramine-treated patients ( -0.9 bpm ) .
CONCLUSIONS	Sibutramine ( 10 mg once daily ) is at least as effective as dexfenfluramine ( 15 mg twice daily ) in achieving weight loss in patients with obesity .

###20367670
BACKGROUND	There remains the need for more effective therapeutic options to treat acne vulgaris .
BACKGROUND	Interest in light-based acne treatments has increased , but few randomized , controlled clinical trials assessing the value of photodynamic therapy ( PDT ) for acne have been reported .
OBJECTIVE	We sought to examine the efficacy of PDT using 5-aminolevulinic acid ( ALA ) and pulsed dye laser therapy in the treatment of acne .
METHODS	We conducted a randomized , controlled , split-face , single-blind clinical trial of 44 patients with facial acne .
METHODS	Patients were randomized to receive three pulsed dye laser treatments to one side of the face after a 60-90 min ALA application time , while the contralateral side remained untreated and served as a control .
METHODS	Serial blinded lesion counts and global acne severity ratings were performed .
RESULTS	Global acne severity ratings improved bilaterally with the improvement noted to be statistically significantly greater in treated skin than in untreated skin .
RESULTS	Erythematous macules ( remnants of previously active inflammatory lesions ) decreased in number in treated skin when compared with control skin and there was a transient but significant decrease in inflammatory papules in treated skin when compared with untreated skin .
RESULTS	There were no other statistically significant differences between treated and untreated sides of the face in terms of counts of any subtype of acne lesion .
RESULTS	Thirty percent of patients were deemed responders to this treatment with respect to improvement in their inflammatory lesion counts , while only 7 % of patients responded in terms of noninflammatory lesion counts .
CONCLUSIONS	PDT with the treatment regimen employed here may be beneficial for a subgroup of patients with inflammatory acne .

###17162326
OBJECTIVE	To evaluate the biopotency of the viable probiotic Lactobacillus acidophilus ( La1 ) in yoghurt matrix consumed by Egyptian children on their plasma vitamin B12 and folate levels , and their metabolic markers methylmalonic acid ( MMA ) and total homocysteine ( t-Hcy ) .
METHODS	A randomized nutritional supplementation trial ( 42 days duration ) was performed in free-living children of both sexes ( 11 years old ) .
METHODS	The La1 in yoghurt matrix was administered to provide 1012 colony-forming units/subject/day .
METHODS	Blood sampling for the analysis of plasma vitamin B12 , folate and t-Hcy was performed by standardized methods .
METHODS	Five-hour urine collection was used for the analysis of MMA and t-Hcy .
RESULTS	Initially 33.3 % of the children presented with biochemical vitamin B12 deficiency ( < 208 pg/ml ) , while one-fifth ( 21 % ) were biochemically deficient in folate ( < 3 ng/ml folate/ml plasma or 0.68 nmol/l ) .
RESULTS	Fifty percent of the children presented with high plasma t-Hcy ( > 15.0 micromol/l ) .
RESULTS	The daily consumption of the probiotic La1 yoghurt for 42 days significantly improved the mean levels of plasma vitamin B12 ( P < 0.05 ) and folate ( P < 0.01 ) among the studied children compared with the respective baseline data .
RESULTS	On the other hand , the average levels of plasma t-Hcy and urinary MMA decreased significantly ( P < 0.05 ) at the termination of the 42-day nutritional supplementation , compared with the respective initial mean levels .
RESULTS	The consumption of the probiotic yoghurt was also associated with a significant ( chi2 = 8.0 ; P < 0.01 ) reduction in the percentage prevalence of anemia ( hemoglobin < 120 g/l ) .
CONCLUSIONS	The long-term ingestion of viable probiotic La1 potentially promoted the overall nutritional status of the studied children .

###21665462
BACKGROUND	Second-line treatment with irinotecan for advanced or metastatic colorectal cancer prolongs survival .
BACKGROUND	It is uncertain whether irinotecan is better administered with 5-fluorouracil or alone in patients previously treated with a fluoropyrimidine .
BACKGROUND	We compared toxicity ( particularly diarrhoea ) , quality of life , and efficacy of combination chemotherapy and irinotecan in these patients .
METHODS	In DaVINCI , a randomised phase II trial , patients with advanced colorectal cancer were randomly allocated to : Combination therapy ( FOLFIRI ) , irinotecan ( 180 mg/m ( 2 ) IV over 90 min , day 1 ) , 5-fluorouracil ( 400mg/m ( 2 ) IV bolus and 2400 mg/m ( 2 ) by 46-hour infusion from day 1 ) and folinic acid ( 20mg/m ( 2 ) IV bolus , day 1 ) , 2-weekly ; or Single-agent , irinotecan ( 350 mg/m ( 2 ) IV over 90 min ) , 3-weekly .
METHODS	Toxicity was evaluated every treatment cycle ; QOL and response 6-weekly .
METHODS	Analysis was by intention to treat .
METHODS	The trial , amended from a larger factorial design , was terminated early due to slow recruitment .
METHODS	Results were also combined with other second-line irinotecan trials .
RESULTS	We randomised 44 patients to combination and 45 to single agent .
RESULTS	Eight patients in the irinotecan arm and 4 in the combination arm had grade 3/4 diarrhoea ( P = 0.24 ) .
RESULTS	Treatment groups did not differ significantly in overall QOL changes , response rate or progression free or overall-survival .
RESULTS	In a systematic review of 29 trials of second-line irinotecan-based treatment , single-agent irinotecan was associated with more diarrhoea and alopecia than the combination but efficacy was similar .
CONCLUSIONS	Combination treatment compared with single-agent irinotecan reduces alopecia and diarrhoea without compromising efficacy on clinical outcomes .
CONCLUSIONS	Both regimens remain as reasonable treatment options .
BACKGROUND	Research grant ( Pfizer ) .

###17426086
BACKGROUND	Low-dose testosterone replacement therapy in women with relative androgen deficiency has been shown to have beneficial effects on body composition , bone mass , and psychosexual function .
BACKGROUND	However , the safety of chronic testosterone administration on cardiovascular risk and insulin resistance is unknown .
OBJECTIVE	The aim of the study was to determine the effects of physiological testosterone replacement on cardiovascular risk markers and insulin resistance in women .
METHODS	A 12-month , randomized , placebo-controlled study was conducted .
METHODS	A General Clinical Research Center was the setting for the study .
METHODS	A total of 51 women of reproductive age with androgen deficiency due to hypopituitarism participated .
METHODS	Study participants were randomized to physiological testosterone administration , 300 mug daily , or placebo , by patch .
METHODS	We measured fasting glucose , fasting insulin , insulin-resistance homeostasis model of assessment ( IRHOMA ) , quantitative insulin sensitivity check index ( QUICKI ) , high-sensitivity C-reactive protein , vascular cell adhesion molecule ( VCAM ) , leptin , lipoprotein ( a ) , apolipoprotein A1 , and homocysteine .
RESULTS	At 12 months , fasting insulin and IRHOMA were significantly lower in the testosterone compared with the placebo group , and there was a trend toward a higher QUICKI level at 12 months in the testosterone compared with the placebo group .
RESULTS	These differences were no longer significant after controlling for baseline levels .
RESULTS	We observed no effect , either positive or negative , of testosterone administration on high-sensitivity C-reactive protein , VCAM leptin , lipoprotein ( a ) , or apolipoprotein A1 .
CONCLUSIONS	Our data suggest that physiological testosterone replacement in women with hypopituitarism for 12 months does not increase , and may improve , insulin resistance .
CONCLUSIONS	Chronic low-dose testosterone administration does not increase markers of cardiovascular disease reflecting several different mechanistic pathways .
CONCLUSIONS	Large , randomized , placebo-controlled , long-term prospective studies are needed to determine whether low-dose testosterone replacement affects cardiovascular risk and event rates in women .

###24560487
OBJECTIVE	We compared biweekly irinotecan plus cisplatin ( BIRIP ) with irinotecan alone as the second-line chemotherapy ( SLC ) for advanced gastric cancer ( AGC ) .
METHODS	Patients with metastatic or recurrent gastric cancer refractory to S-1-based first-line chemotherapy were randomly assigned to receive BIRIP ( irinotecan 60mg/m ( 2 ) plus cisplatin 30mg/m ( 2 ) , every 2weeks ) or irinotecan alone ( irinotecan 150mg/m ( 2 ) , every 2weeks ) .
METHODS	The primary end-point was to show the superiority of BIRIP to irinotecan in terms of progression free survival ( PFS ) .
RESULTS	130 patients were enrolled .
RESULTS	PFS was significantly longer in the BIRIP group ( 3.8 months [ 95 % confidence interval ( CI ) 3.0-4 .7 ] ) than in the irinotecan group ( 2.8 months [ 2.1-3 .3 ] ; hazard ratio 0.68 , 95 % CI 0.47-0 .98 ; P = 0.0398 ) .
RESULTS	Median overall survival was 10.7 months in the BIRIP group and 10.1 months in the irinotecan group ( HR 1.00 , 95 % CI 0.69-1 .44 , P = 0.9823 ) .
RESULTS	The objective response rate was 22 % in the BIRIP group and 16 % in the irinotecan group ( P = 0.4975 ) .
RESULTS	However , the disease control rate was significantly better in the BIRIP group ( 75 % ) than in the irinotecan group ( 54 % , P = 0.0162 ) .
RESULTS	The incidences of grade 3 or worse adverse events did not differ between the two groups .
RESULTS	Any grade elevation of serum creatinine was more common in the BIRIP group ( 25 % versus 8 % , P = 0.009 ) , but any grade diarrhoea ( 17 % versus 42 % , P = 0.002 ) was more common in the irinotecan group .
CONCLUSIONS	BIRIP significantly prolonged PFS as compared with irinotecan alone and was tolerated as SLC , but did not demonstrate the survival benefit in this trial .

###23273888
OBJECTIVE	To compare efficacy and tolerability between different regimens of rifaximin vaginal tablets and a placebo for treatment of bacterial vaginosis .
METHODS	In a prospective study carried out at 13 sites in 3 European countries between August 2009 and October 2010 , White , non-pregnant , premenopausal women with bacterial vaginosis were randomly assigned to receive rifaximin at 100mg for 5 days ( 100mg/5 days ) , 25mg/5 days , or 100mg/2 days , or placebo .
METHODS	Women were assessed at 7-10 and 28-35 days .
METHODS	Diagnosis and cure were based on Amsel criteria and Nugent score .
METHODS	Fisher exact test was used to compare cure rates .
RESULTS	Among 114 women recruited , 103 were evaluable for drug efficacy .
RESULTS	Therapeutic cure rate at first follow-up was higher in the rifaximin 25mg/5 days ( 48 % , P = 0.04 ) , 100mg/2 days ( 36.0 % ) , and 100mg/5 days ( 25.9 % ) groups than in the placebo group ( 19.0 % ) .
RESULTS	At second follow-up , therapeutic cure rate was 28.0 % , 14.8 % , and 4.0 % in the respective groups versus 7.7 % in the placebo group .
RESULTS	No difference in adverse events was observed .
CONCLUSIONS	Rifaximin at 25mg/5 days showed better therapeutic cure rates and maintenance of therapeutic cure after 1 month versus placebo .
CONCLUSIONS	All treatment regimens were well tolerated .
CONCLUSIONS	EudraCT number : 2009-011826-32 .

###15086924
BACKGROUND	Variation in the timing of calcium supplement may affect gastrointestinal absorption of both calcium and oxalate differently and may associate with variable risk of calcium oxalate nephrolithiasis .
BACKGROUND	There are few human studies addressing specifically the appropriate time for taking calcium supplement .
BACKGROUND	Therefore , this study was performed to compare calcium bioavailability and the risk of calcium oxalate stone formation for calcium supplement taken with meal vs. taken at bedtime .
METHODS	Thirty-two healthy male navy privates , 22.7 + / - 1.9 years old ( mean + / - SD ) , who had normal renal function ( serum creatinine less than 150 umol/L ) and no history of renal stone , participated in the study .
METHODS	The subjects were randomly allocated into two groups of 16 each .
METHODS	Group A took 1 g of calcium carbonate with meal , 3 times/day ; and group B took 3 g/day of calcium carbonate at bedtime .
METHODS	After taking the regimens for 1 week , followed by 1 month of washout period , crossover between both groups was done .
METHODS	The diet was controlled throughout the study .
METHODS	Twenty-four-hour urine collections for the determination of urinary constituents were obtained at baseline and after taking both regimens of calcium supplement .
METHODS	Activity product for calcium oxalate was determined to assess the risk of calcium oxalate stone formation .
RESULTS	Urinary excretions of calcium were significantly elevated above the baseline values when taking calcium supplement both with meal ( 3.48 + / - 2.13 mmol/day vs. 5.17 + / - 2.61 mmol/day , P < 0.05 ) and at bedtime ( 3.09 + / - 1.70 mmol/day vs. 5.08 + / - 2.34 mmol/day , P < 0.05 ) .
RESULTS	There was no difference between the two regimens in the urinary calcium excretions .
RESULTS	The urinary oxalate was decreased significantly when the subjects took calcium supplement with meal compared with the corresponding baseline value ( 0.13 + / - 0.05 vs. 0.17 + / - 0.07 mmol/d , P = 0.01 ) .
RESULTS	In contrast , there was no alteration in urinary oxalate when calcium supplement was taken at bedtime compared to the baseline values ( 0.15 + / - 0.05 mmol/day vs. 0.15 + / - 0.06 mmol/day , P = 0.9 ) .
RESULTS	Compared with the corresponding baseline values , there was no significant increase in the activity product for calcium oxalate when taking calcium with meal ( 0.54 + / - 0.25 vs. 0.57 + / - 0.22 , P = 0.54 ) , but it was increased significantly when calcium supplement was taken at bedtime ( 0.47 + / - 0.21 vs. 0.72 + / - 0.27 , P < 0.01 ) .
CONCLUSIONS	Calcium supplement should be taken with meal in order to avoid increasing the risk of calcium oxalate nephrolithiasis .

###25390870
OBJECTIVE	The aim of this preliminary clinical report was to evaluate and compare the clinical outcomes of immediate and early loaded mini-implants ( MIs ) supporting mandibular overdentures .
METHODS	Thirty-six completely edentulous patients ( 20 men and 16 women ) complaining of insufficient retention of their mandibular dentures were randomly assigned to two groups .
METHODS	Each patient received four MIs in the interforaminal area of the mandible using the nonsubmerged flapless surgical approach .
METHODS	In group 1 ( G1 ) , MIs were loaded with mandibular overdentures using the immediate loading protocol , while in group 2 ( G2 ) , MIs were loaded with overdentures using the early loading protocol .
METHODS	The cumulative survival rate was calculated using Kaplan-Meier analysis .
METHODS	Peri-implant health indices ( Plaque Index/Bleeding Index ) , probing depths , and marginal bone levels were recorded for both groups after MI insertions and 6 , 12 , 24 , and 36 months thereafter .
RESULTS	The cumulative implant survival rates were 91.7 % and 96.7 % for G1 and G2 , respectively .
RESULTS	G1 recorded significantly higher Plaque Index , Bleeding Index , and probing depths than G2 after 12 months , while other observation times demonstrated no significant difference between groups .
RESULTS	Most of the recorded marginal bone loss occurred in the first year , and no significant bone loss was noted in subsequent years .
RESULTS	After 6 months , marginal bone loss was significantly higher in G1 compared to G2 , but no significant differences between groups were noted thereafter .
CONCLUSIONS	Within the limitations of this study 's research design and duration of follow-up outcome analyses , immediate and early loading protocols showed good clinical results with favorable peri-implant tissue response 3 years after implant insertion .
CONCLUSIONS	Early loading of MIs supporting a mandibular overdenture appears to be preferable to immediate loading .

###23139262
BACKGROUND	There is no proven benefit of adjuvant treatment of uterine sarcoma ( US ) .
BACKGROUND	SARCGYN phase III study compared adjuvant polychemotherapy followed by pelvic radiotherapy ( RT ) ( arm A ) versus RT alone ( arm B ) conducted to detect an increase 20 % of 3-year PFS .
METHODS	Patients with FIGO stage III US , physiological age 65 years ; chemotherapy : four cycles of doxorubicin 50 mg/m ?
METHODS	d1 , ifosfamide 3 g/m ?
METHODS	/ day d1-2 , cisplatin 75 mg/m ?
METHODS	d3 , ( API ) + G-CSF q 3 weeks .
METHODS	Study was stopped because of lack of recruitment .
RESULTS	Eighty-one patients were included : 39 in arm A and 42 in arm B ; 52 stage I , 16 stage II , 13 stage III ; 53 leiomyosarcomas , 9 undifferenciated sarcomas , 19 carcinosarcomas .
RESULTS	Gr 3-4 toxicity during API ( / 37 patients ) : thrombopenia ( 76 % ) , febrile neutropenia ( 22 % ) with two toxic deaths ; renal gr 3 ( 1 patient ) .
RESULTS	After a median follow-up of 4.3 years , 41/81 patients recurred , 15 in arm A , 26 in arm B.
RESULTS	The 3 years DFS is 55 % in arm A , 41 % in arm B ( P = 0.048 ) .
RESULTS	The 3-year overall survival ( OS ) is 81 % in arm A and 69 % in arm B ( P = 0.41 ) .
CONCLUSIONS	API adjuvant CT statistically increases the 3 year-DFS of patients with US .

###23018869
BACKGROUND	Surgical treatment for carpal tunnel syndrome does not always alleviate sensory deficits , especially in patients with severe disease .
BACKGROUND	No proven treatment is currently available for these patients .
METHODS	We conducted a pilot randomized , controlled trial to evaluate the feasibility , patient acceptability , and efficacy of a sensory relearning ( SR ) program in patients who have ongoing sensory deficits after carpal tunnel decompression .
METHODS	Patients were randomized to receive either : ( i ) a 4-week sensory relearning home program ; or ( ii ) no further treatment .
METHODS	Outcomes were assessed at baseline and 4 and 8 weeks after randomization .
RESULTS	Thirty-one patients were randomized .
RESULTS	Efficacy analysis adjusted for baseline score and age showed a potentially clinically worthwhile benefit of SR. .
CONCLUSIONS	Data on screening , eligibility , and patient acceptability of the intervention confirm the feasibility of undertaking a definitive randomized , controlled trial .

###17323789
OBJECTIVE	The authors compared the pharmacokinetics and pharmacological effects of the immunomodulator fingolimod in healthy white and Asian subjects for potential ethnic differences .
METHODS	White and Asian ( Japanese ) healthy subjects were demographically matched for sex , age and weight .
METHODS	Subjects received single 1.25 mg doses of fingolimod ( 6 ethnic pairs ) , 2.5 mg ( 7 pairs ) , 5 mg ( 6 pairs ) or 5 mg/day for 7 days ( 6 pairs ) .
METHODS	The pharmacokinetics of fingolimod , major metabolites , peripheral blood lymphocyte counts and heart rate were characterized over 1 month after single-dose and 2 months after multiple-dose administration .
RESULTS	There were no clinically relevant differences in the fingolimod dose Cmax or dose AUC relationships between Asian subjects ( slopes 0.84 and 1.05 ) versus white subjects ( slopes 1.13 and 1.26 ) after single-dose administration .
RESULTS	During multiple-dose administration , there were no clinically relevant interethnic differences in fingolimod accumulation ratios ( 6.6 + / - 0.4 for whites , 7.0 + / - 0.7 for Asians ) , area under the concentration-time curve ( 390 + / - 73 versus 382 + / - 106 ng x h/ml ) , or elimination half-life ( 7.4 + / - 0.8 versus 7.9 + / - 2.0 days ) .
RESULTS	The acute decrease in lymphocyte counts after single - and multiple-dose fingolimod were similar in the two ethnic groups .
RESULTS	The lymphocyte recovery rate to baseline after a 5 mg single dose and 5 mg/day multiple dose was reduced by 36 and 15 % in Asian subjects compared with white subjects .
RESULTS	The transient , acute decrease in heart rate after the first dose of fingolimod and the subsequent return to baseline was similar in the two ethnic groups .
CONCLUSIONS	There were no marked differences between healthy white and Asian subjects in fingolimod single-dose and multiple-dose pharmacokinetics , lymphocyte trafficking and heart rate responses .

###15576543
OBJECTIVE	We wanted to evaluate the added value of small peer-group quality improvement meetings compared with simple feedback as a strategy to improve test-ordering behavior .
OBJECTIVE	Numbers of tests ordered by primary care physicians are increasing , and many of these tests seem to be unnecessary according to established , evidence-based guidelines .
METHODS	We enrolled 194 primary care physicians from 27 local primary care practice groups in 5 health care regions ( 5 diagnostic centers ) .
METHODS	The study was a cluster randomized trial with randomization at the local physician group level .
METHODS	We evaluated an innovative , multifaceted strategy , combining written comparative feedback , group education on national guidelines , and social influence by peers in quality improvement sessions in small groups .
METHODS	The strategy was aimed at 3 specific clinical topics : cardiovascular issues , upper abdominal complaints , and lower abdominal complaints .
METHODS	The mean number of tests per physician per 6 months at baseline and the physicians ' region were used as independent variables , and the mean number of tests per physician per 6 months was the dependent variable .
RESULTS	The new strategy was executed in 13 primary care groups , whereas 14 groups received feedback only .
RESULTS	For all 3 clinical topics , the decrease in mean total number of tests ordered by physicians in the intervention arm was far more substantial ( on average 51 fewer tests per physician per half-year ) than the decrease in mean number of tests ordered by physicians in the feedback arm ( P = .005 ) .
RESULTS	Five tests considered to be inappropriate for the clinical problem of upper abdominal complaints decreased in the intervention arm , with physicians in the feedback arm ordering 13 more tests per 6 months ( P = .002 ) .
RESULTS	Interdoctor variation in test ordering decreased more in the intervention arm .
CONCLUSIONS	Compared with only disseminating comparative feedback reports to primary care physicians , the new strategy of involving peer interaction and social influence improved the physicians ' test-ordering behavior .
CONCLUSIONS	To be effective , feedback needs to be integrated in an interactive , educational environment .

###17233688
OBJECTIVE	To evaluate the effect of a psychiatric intervention in treating depression ( treatment study ) and the effect of a psychological treatment in preventing depression ( prevention study ) after hip fracture in older people .
METHODS	Two linked randomized , controlled trials .
METHODS	Orthopedic units in Manchester , England .
METHODS	Two hundred ninety-three older people who had undergone surgery for a fractured hip : 121 in the treatment study and 172 in the prevention study .
METHODS	The Geriatric Depression Scale and Hospital Anxiety and Depression Scale for mood , functional tests for mobility and pain measures .
RESULTS	There was a slight reduction in depressive symptoms in the active arm of the treatment study .
RESULTS	In the prevention study , there was no significant difference in incident depression between the psychological intervention and treatment as usual .
RESULTS	There were no differences in the functional and pain outcomes .
CONCLUSIONS	The results from these two randomized , controlled trials show that , after hip fracture surgery , no statistically significant benefits can be achieved from a psychiatric intervention in people who are depressed or a psychological intervention to prevent the onset of depression .

###17588420
BACKGROUND	Sternal wound infections are a major complication after cardiac surgery in terms of morbidity and cost increase .
BACKGROUND	To decrease the incidence of infection , we evaluated triclosan-coated sutures for the closure of the sternal incision , as it is known that most of the surgical site infections are related to the incision site .
METHODS	From May to December 2005 , a total of 479 patients underwent a cardiac surgical procedure .
METHODS	From those , 103 patients were closed with triclosan-coated suture material ( cost per patient $ 30 [ in United States dollars ] ) , whereas the remaining 376 patients had their incision closed with noncoated sutures ( cost per patient $ 21 ) .
RESULTS	During the study period , 24 patients had superficial ( n = 10 ) or deep ( n = 14 ) sternal wound infections ( cost per patient $ 11,200 ) .
RESULTS	All those patients were closed with conventional suture material .
RESULTS	In the triclosan group , no wound infection or dehiscence was observed during hospital stay and follow-up visits .
CONCLUSIONS	Triclosan-coated sutures might be valuable in the reduction of sternal wound infections and avoid the suture being a risk factor for surgical site infections .
CONCLUSIONS	The increased cost of the coated suture material has to be weighed against the enormous cost of sternal wound infections caused directly by the cost of care as well as indirectly through the loss of economic productivity .

###8625627
OBJECTIVE	To evaluate the benefit of recombinant human growth hormone administration on muscle strength and duration of weaning in critically ill patients undergoing prolonged mechanical ventilation .
METHODS	Prospective , randomized , controlled , single-blind study .
METHODS	Intensive care unit .
METHODS	Twenty patients requiring > or = 7 days of mechanical ventilation for acute respiratory failure .
METHODS	Random assignment to receive either 0.43 IU ( approximately 0.14 mg ) recombinant growth hormone/kg body weight/day ( treated group ) , or saline ( nontreated group ) for 12 days .
RESULTS	Nutritional support was guided by indirect calorimetry .
RESULTS	Cumulative nitrogen balance was positive throughout the study period in the treated group 17.3 ( 44.9 + / - 17.3 [ SEM ] g/12 days ) vs. the nontreated group ( -65.8 + / - 11.8 g/12 days ) ( p < .0001 ) .
RESULTS	Despite similar initial plasma concentrations , recombinant growth hormone supplementation resulted in marked increases in growth hormone , insulin like growth factor-1 , and insulin concentrations ( p < .05 , .02 , and .0001 , respectively , vs. nontreated group ) .
RESULTS	Body impedance determined net fat-free mass increased in the treated group ( 0.8 + / - 0.6 kg ) vs. the nontreated group ( -1.1 + / - O. 5 kg ) ( p < .03 ) .
RESULTS	Initial peripheral muscle function , assessed by computer-controlled electrical stimulation of the adductor pollicis , was similarly lower in treated and nontreated groups than sex and age-matched normal controls , and decreased further during the study period .
RESULTS	Arterial blood gases , cumulative total mechanical ventilation time , and number of hrs/day of mechanical ventilation during weaning were similar in both patient groups .
RESULTS	Only three of the ten patients in each group were weaned from mechanical ventilation by day 12 .
CONCLUSIONS	Daily administration of recombinant growth hormone in mechanically ventilated patients with acute respiratory failure promotes a marked nitrogen retention .
CONCLUSIONS	However , this reaction is accompanied neither by an improvement in muscle strength nor by a shorter duration of ventilatory supports .

###9594320
OBJECTIVE	To investigate the effects of different doses of intravenous domestic urokinase .
METHODS	One thousand and twenty three cases of acute myocardial infarction within 6 hours after acute onset were divided randomly into two groups with 539 cases in the low dose group ( urokinase 22,000 IU/kg , total dose not lower than 1.2 million ) and 484 in the high dose group ( 30,000 IU/kg , total dose not more than 2.4 million ) .
METHODS	The patency of infarct-related coronary artery was assessed by uniform clinical criteria .
RESULTS	In the low and high dose groups the patency rates were 67.3 % and 67.8 % respectively ( P > 0.05 ) ; 4-week mortalities were 9.5 % and 8.7 % respectively ( P > 0.05 ) .
RESULTS	Frequency of severe complications had no statistically significant difference between the two groups .
RESULTS	Adverse bleeding was a little more frequent in the high than in the low dose group , and fatal cerebral hemorrhage in 2 cases occurred in the high dose group .
CONCLUSIONS	Low dose urokinase , 22,000 IU per kg body weight with a total dose not lower than 1.2 million IU , is not only equally effective as high dose but also safer .

###7775717
OBJECTIVE	To determine if oxybutynin , a bladder relaxant medication , adds to the effectiveness of prompted voiding ( PV ) in the management of urinary incontinence among nursing home residents .
METHODS	Randomized , placebo-controlled , double-blinded , dose-adjusted , crossover trial of oxybutynin added along with PV .
METHODS	Seven nursing homes in Los Angeles County , California .
METHODS	Seventy-five nursing home residents with predominantly urge incontinence , whose incontinence did not respond well to a trial of PV .
METHODS	The frequency of incontinence , measured as the percentage of hourly ( 7 AM to 7 PM ) physical checks over a 3-day period at which the resident was found wet .
RESULTS	Sixty-three ( 84 % ) of the residents completed the study .
RESULTS	Among those completing the trial , the percent of checks wet went from 26.5 % to 23.7 % on placebo to 20.2 % on active drug .
RESULTS	These changes were statistically significant but not clinically meaningful .
RESULTS	A clinically significant decrease in the frequency of incontinence , which we defined as a relative reduction in the percent of checks wet of > 33 % , occurred in 20 subjects ( 32 % ) while on active drug and in 12 subjects ( 19 % ) while on placebo ( P = .48 by chi-square ) .
RESULTS	Twenty-five subjects ( 40 % ) met our `` continence criteria '' of an average of one or less wet per day while on active drug , and 11 subjects ( 18 % ) achieved this goal on placebo ( P = .005 by chi-square ) .
CONCLUSIONS	Oxybutynin does not add to the clinical effectiveness of PV in the majority of nursing home residents with urge type urinary incontinence .
CONCLUSIONS	Selected residents may , however , become more responsive to PV while on oxybutynin .
CONCLUSIONS	Our data are consistent with other studies of bladder relaxant medications in functionally impaired populations .
CONCLUSIONS	New drugs and/or other interventions are needed for the large number of incontinent nursing home residents who do not respond well to PV .

###11504984
OBJECTIVE	To assess the antiviral efficacy , safety and adherence in patients switched to an abacavir-containing nucleoside reverse transcriptase inhibitor ( NRTI ) regimen after long-term HIV-1 RNA suppression with a dual NRTI/protease inhibitor ( PI ) combination .
METHODS	In an open-label , multicentre study , patients receiving 2NRTI plus PI for at least 6 months , with a history of undetectable plasma HIV-1 RNA since the initiation of therapy and plasma HIV-1 RNA < 50 copies/ml at screening , were randomly assigned to replace the PI with abacavir ( n = 105 ) or continue the same treatment ( n = 106 ) .
METHODS	Clinical assessments included plasma HIV-1 RNA , chemistry , haematology , lymphocyte counts , and adverse event reports .
METHODS	Adherence to treatment was assessed by patient self-report .
RESULTS	A significantly longer time to treatment failure was demonstrated in the abacavir arm compared with the PI arm ( P = 0.03 ) while treatment failure was experienced by significantly more patients in the PI arm : 24 ( 23 % ) versus 12 ( 12 % ) ( P = 0.03 ) .
RESULTS	Therapy-limiting toxicity led to treatment failure in eight versus 14 cases in the abacavir and PI arms , respectively , whereas virological rebound was the cause in four versus two cases .
RESULTS	Significant reductions in cholesterol and non-fasting triglyceride plasma levels at 48 weeks were observed in the abacavir arm ( P < 0.001 andP = 0.035 , respectively ) .
RESULTS	The number of patients reporting no difficulty in taking their therapy showed a marked increase from baseline in the abacavir arm .
CONCLUSIONS	The replacement of PI by abacavir in a triple combination regimen following prolonged suppression of plasma HIV-1 RNA provides continued virological suppression , significant improvements in lipid abnormalities and enhanced ease of dosing .

###15705119
OBJECTIVE	To investigate the effect of low-intensity acenocoumarol treatment ( target INR 1.5 to 2.0 ) on the frequency and severity of migraine attacks .
BACKGROUND	The positive effect of anticoagulation on migraine has been described in case reports and observational studies .
METHODS	We conducted a randomized , open , crossover study in migraine patients .
METHODS	After a run-in period of 8 weeks , all patients received acenocoumarol or propranolol during a period of 12 weeks and , after a washout period of 2 weeks , propranolol or acenocoumarol during a second period of 12 weeks .
RESULTS	Nineteen patients fulfilling the criteria were included .
RESULTS	In 12 patients with complete data collection , only one good responder could be noted .
RESULTS	In the other patients , treatment with low-intensity acenocoumarol did not show improvement of migraine symptoms compared with the run-in period .
RESULTS	Treatment with propranolol showed a trend towards improvement compared with the run-in period .
RESULTS	No serious adverse events were observed .
CONCLUSIONS	Overall , low-intensity acenocoumarol treatment has no prophylactic effect in migraine patients .

###15591955
BACKGROUND	In renal transplantation , the immunosuppressive efficacy of cyclosporine is counterbalanced by its nephrotoxicity .
BACKGROUND	Although cyclosporine improves short-term graft survival , its long-term effects are unclear .
METHODS	Recipients of first cadaver renal transplants were randomized into three groups between 1983 and 1986 : azathioprine and prednisolone alone ( AP , n = 158 ) , long term cyclosporine alone ( Cy , n = 166 ) , and short-term cyclosporine followed by azathioprine and prednisolone ( CyAP , n = 165 ) .
METHODS	All groups received methylprednisolone induction .
RESULTS	There were no significant differences in patient survival at 15 years ( 48 vs. 56 vs. 51 % , P = 0.14 ) , and 15-year graft survival ( censored for death ) in those patients in the CyAP group ( 47 vs. 44 vs. 59 % , P = 0.06 ) was not significantly different statistically .
RESULTS	When deaths or graft losses before 12 months were censored , the differences in 15-year graft survival between the groups were significant ( 58 % , 51 % , 70 % , P = 0.01 ) .
RESULTS	The CyAP group also had lower mean serum creatinine at all time points beyond 3 months posttransplant out to 10 years ( 143 vs. 169 vs. 131 micromoles/L , P = 0.04 ) .
RESULTS	Per protocol analysis , after censoring patients at change in therapy , increased the observed differences in 15-year graft survival between the groups ( 54 vs. 38 vs. 65 % , P = 0.01 ) .
CONCLUSIONS	Survival and function of first cadaveric kidney transplants is improved by use of short-term cyclosporine followed by azathioprine and prednisolone .
CONCLUSIONS	Long-term cyclosporine use reduces long-term graft survival .

###22797979
OBJECTIVE	To demonstrate non-inferiority of gadobutrol versus gadobenate dimeglumine by intra-individually comparing 0.1 mmol/kg body weight doses for contrast-enhanced breast magnetic resonance imaging ( MRI ) and prospectively evaluating lesion detection and characterisation in a multicentre trial .
METHODS	Two identical breast MRI examinations were performed in 72 patients with biopsy-proven breast cancer , separated by 1-7 days .
METHODS	Gadobutrol 1.0 M or gadobenate 0.5 M were administered in a randomised order .
METHODS	Lesion detection and characterisation were performed by two independent blinded readers .
METHODS	Lesion tracking , which compared on-site readings and histology from surgery or biopsy , was performed by a third reader .
METHODS	Differences in lesion detection and characterisation were compared between the two contrast agents .
RESULTS	Among 103 lesions , 96 were malignant and 7 were benign .
RESULTS	No difference in lesion detection was identified between the contrast agents ( 82.33 % for gadobutrol , 81.60 % for gadobenate ) .
RESULTS	Assessment of sensitivity in lesion characterisation and Breast Imaging Reporting and Data Systems showed no difference between gadobutrol ( 92.63 % ) and gadobenate ( 90.53 % ) .
RESULTS	Regarding morphology , there was more non-focal enhancement for gadobutrol than for gadobenate ( P = 0.0057 ) .
CONCLUSIONS	Non-inferiority of gadobutrol compared with gadobenate was demonstrated for breast lesion detection and sensitivity in lesion characterisation in breast MRI .

###25208756
OBJECTIVE	The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea .
METHODS	This was a randomised , open-label , multicentre ( n = 222 ) , parallel-group , non-inferiority out-patient clinical trial , with 779 patients enrolled in the study .
METHODS	The study was conducted in 222 centres located in four countries .
METHODS	Patients aged 18 years with type 2 diabetes treated with metformin ( sulfonylurea ) for at least 3 months with a baseline HbA1c 7.0-10 .0 % ( 53.0-85 .8 mmol/mol ) were randomly assigned ( 2:1 ) via a computer-generated randomisation sequence with a voice response system to receive albiglutide ( 30 mg once a week , n = 504 ) or insulin glargine ( 10 U once a day , n = 241 ) added to current therapy .
METHODS	Participants and investigators were not masked to treatment assignment .
METHODS	Doses of each medication were adjusted on the basis of the glycaemic response .
METHODS	The primary endpoint was change from baseline in HbA1c at week 52 .
RESULTS	In the albiglutide group , HbA1c declined from 8.280.90 % ( 67.09.8 mmol/mol ) ( meanSD ) at baseline to 7.621.12 % ( 59.812.2 mmol/mol ) at week 52 .
RESULTS	A similar reduction occurred in the insulin glargine group ( 8.360.95 % to 7.551.04 % [ 67.910.4 to 59.011.4 mmol/mol ] ) .
RESULTS	The model-adjusted treatment difference of 0.11 % ( 95 % CI -0.04 % , 0.27 % ) ( 1.2 mmol/mol [ 95 % CI -0.4 , 3.0 mmol/mol ] ) indicated non-inferiority of albiglutide to insulin glargine based on the pre-specified non-inferiority margin of 0.3 % ( 3.3 mmol/mol , p = 0.0086 ) .
RESULTS	Body weight increased in the insulin glargine group and decreased in the albiglutide group , with a mean treatment difference of -2.61 kg ( 95 % CI -3.20 , -2.02 ; p < 0.0001 ) .
RESULTS	Documented symptomatic hypoglycaemia occurred in a higher proportion of patients in the insulin glargine group than in the albiglutide group ( 27.4 % vs 17.5 % , p = 0.0377 ) .
CONCLUSIONS	Albiglutide was non-inferior to insulin glargine at reducing HbA1c at week 52 , with modest weight loss and less hypoglycaemia .
CONCLUSIONS	Both drugs were well tolerated .
CONCLUSIONS	Albiglutide may be considered an alternative to insulin glargine in this patient population .
BACKGROUND	ClinicalTrials.gov NCT00838916 ( completed )
BACKGROUND	This study was planned and conducted by GlaxoSmithKline .

###9147856
BACKGROUND	In adjuvant therapy of patients with multiple myeloma among others anti-absorption properties of bisphosphonates are used .
BACKGROUND	The objective of the present investigation was to evaluate the effect of long-term oral treatment route clodronate on the bone metabolism in this condition .
BACKGROUND	As markers of bone reabsorption , assessment of pyridinoline and deoxypyridinoline in urine was used .
RESULTS	We investigated in an open clinical trial 22 patients with multiple myeloma with bone changes confirmed on X-ray who had a normal calcium and creatinine serum concentration : the control group ( A ) comprised 13 patients ( mean age 59 years , range 38-74 years ) , the experimental group ( B ) 9 patients ( mean age 54 years , range 42-60 years ) .
RESULTS	The patients in both groups were treated by chemotherapy , to group B concurrently clodronate 3 x 800 mg was administered by the oral route .
RESULTS	No statistically significant differences were found between the two groups during the mean follow up period after assessment of the diagnosis ( 27 vs. 40 months ) nor in the clinical stage of the disease .
RESULTS	After intervals of 0 , 3 and 12 months the excretion of pyridinoline and deoxypyridinoline in urine was assessed by liquid chromatography .
RESULTS	At the same time also other parameters of osteoresorption were assessed ( urinary calcium and hydroxyproline excretion ) .
RESULTS	At the onset of the investigation the pyridinoline and deoxypyridinoline excretion in groups A and B did not differ statistically ( pyr ; 120.63 + / - 23.76 vs. 136.23 + / - 22.13 mumol/mmol creatinine .
RESULTS	d-pyr : 19.61 + / - 3.65 vs. 22.76 + / - 5.40 mumol/mmol creatinine ) .
RESULTS	After three months in group B a statistically significant drop of excretion of both metabolites was recorded ( pyr .
RESULTS	to 84.11 + / - 38.67 mumol/mmol creatinine , d-pyr .
RESULTS	to 15.23 + / - 6.10 mumol/mmol creatinine ) .
RESULTS	Their significantly reduced excretion persisted also after one year ( pyr .
RESULTS	85.52 + / - 60.96 mumol/mmol creatinine , d-pyr .
RESULTS	12.6 + / - 6.56 mumol/mmol creatinine ) .
CONCLUSIONS	Using specific markers , pyridinoline and deoxypyridinoline , the authors proved the favourable effect of long-term administration of clodronate on the bone metabolism in patients with multiple myeloma .

###22760426
OBJECTIVE	To study the efficacy of oral mucosal decontamination with chlorhexidine gel for the prevention of ventilator-associated pneumonia in children between 3 months and 15 yrs .
METHODS	Double blind randomized placebo controlled trial .
METHODS	Pediatric intensive care unit of a tertiary care hospital in North India .
METHODS	Eligible participants were patients aged 3 months to 15 yrs who required orotracheal or nasotracheal intubation and mechanical ventilation .
METHODS	Two hundred eighty-three children admitted to the pediatric intensive care unit between November 2007 and April 2009 were screened .
METHODS	Eighty-six patients fulfilled the study requirements .
METHODS	Either 1 % chlorhexidine or placebo gel was applied on the buccal mucosa at 8-hr intervals for the entire duration of ventilation , subject to a maximum of 21 days .
METHODS	Patients were followed up for the development of ventilator-associated pneumonia , diagnosed using the Centers for Disease Control and Prevention criteria .
METHODS	Incidence of ventilator-associated pneumonia , duration of hospital stay , duration of intensive care unit stay , mortality , and characteristics of organisms isolated .
RESULTS	Fourty-one children received 1 % chlorhexidine , whereas 45 received placebo application .
RESULTS	Patients of both groups were comparable with respect to baseline characteristics .
RESULTS	Incidence of ventilator-associated pneumonia was 39.6 / 1,000 ventilator days with 1 % chlorhexidine and 38.1 / 1,000 ventilator days with placebo ( relative risk 1.03 , confidence interval 0.44-2 .42 , p = .46 ) .
RESULTS	The duration of intensive care unit stay and hospital stay was a mean of 8.4 5.8 vs. 9.6 11.4 days ( p = .58 ) and 16.1 10.2 days vs. 15.1 14.3 days ( p = .19 ) with chlorhexidine and placebo , respectively .
RESULTS	The mortality rates were similar in the two groups ( p = .81 ) .
RESULTS	All but two isolates causing ventilator-associated pneumonia were gram-negative , with Acinetobacter species being the most common ( 14 of 26 ) .
RESULTS	No side effects of the applied gel were seen in either group .
CONCLUSIONS	Oral mucosal application on 1 % chlorhexidine gel did not prevent the development of ventilator-associated pneumonia in children 3 months to 15 yrs age .

###20200016
OBJECTIVE	Amiodarone is associated with significant adverse effects .
OBJECTIVE	We hypothesized that episodic amiodarone treatment would be associated with better quality of life ( QoL ) compared with continuous treatment in the prevention of recurrent atrial fibrillation ( AF ) .
RESULTS	Quality of life was assessed in 158 patients from the Continuous vs. Episodic Prophylactic Treatment with Amiodarone for the Prevention of AF ( CONVERT ) study , using the Short Form ( SF ) -36 health survey and University of Toronto AF Severity Scale ( AF severity scale ) questionnaires at baseline and 1 year .
RESULTS	The episodic group received amiodarone 1 month peri-cardioversion , the continuous group continued amiodarone .
RESULTS	Patients were assessed for major adverse events and maintenance of sinus rhythm during follow-up ( i.e. no AF recurrences at every follow-up visit ) .
RESULTS	Quality of life ( assessed by SF-36 and AF severity scale ) was comparable between both treatment groups at baseline and 12 months , with similar incidence rates of major adverse events .
RESULTS	Fewer patients in the episodic group had maintenance of sinus rhythm during follow-up [ 27 ( 36 % ) vs. 49 ( 59 % ) , P = 0.004 ] .
RESULTS	In the episodic group , maintenance of sinus rhythm was associated with a significant improvement on four SF-36 subscales and AF severity scale at 12 months .
RESULTS	In contrast , in the continuous group no significant differences in QoL were seen between patients with continued maintenance of sinus rhythm compared with those with AF recurrence at the end of follow-up .
CONCLUSIONS	Quality of life was comparable in the episodic and continuous treated group after 12 months of follow-up .
CONCLUSIONS	Continued maintenance of sinus rhythm was associated with an improvement in QoL in the episodic but not the continuous treated group .

###23539462
OBJECTIVE	Manual small-incision cataract surgery ( MSICS ) is a viable method for cataract surgery around the world .
OBJECTIVE	We evaluated the impact of a modification of MSICS , in which an anterior chamber maintainer is used throughout the surgery with the addition of ocular viscoelastic device prior to nucleus removal ( M-MSICS ) , on the corneal endothelium .
METHODS	This prospective study comprised patients randomly assigned for cataract surgery who underwent M-MSICS .
METHODS	Patients underwent corneal endothelial counts by a noncontact specular microscopy in the center and at 12 and 6 o'clock position as well as central corneal pachymetry ( CCT ) preoperatively , and at 1 week and 1 and 3 months postoperatively .
RESULTS	Twenty-one eyes were included , 16 of which completed the entire follow-up .
RESULTS	There was a statistically significant difference in endothelial cell loss at the center of the cornea at 1 week postoperatively ( p = 0.003 ) .
RESULTS	However , there was no significant difference in endothelial cell measurements between preoperative and other postoperative timepoints at the center of the cornea .
RESULTS	In addition , no significant difference was found in the 12 and 6 o'clock measurements at all timepoints .
RESULTS	There was a mild but statistically significant increase in CCT at the center of the cornea at 1-week and 1-month postoperative measurements as compared to preoperative measurement ( p < 0.05 ) .
RESULTS	By postoperative month 3 , CCT had returned to baseline level .
CONCLUSIONS	Modified MSICS offers a viable enhancement of MSICS , with mild and transient impact on the corneal endothelial cell density and corneal pachymetry .

###21725919
BACKGROUND	Several nonimmunologic risk factors for late renal graft loss ( RGL ) are also known components of metabolic syndrome ( MS ) .
BACKGROUND	We aimed to study MS as a risk factor for RGL .
BACKGROUND	Also , the effect of statin treatment in reducing renal risk in renal transplant recipients ( RTRs ) with MS was studied .
METHODS	Nondiabetic RTRs ( n = 1,706 ) from the ALERT trial were followed for 7-8 years .
METHODS	MS was defined according to National Cholesterol Education Program Adult Treatment Panel III definition with waist girth replaced by BMI 30 ( calculated as kg/m ( 2 ) ) .
METHODS	Renal end points included death-censored RGL and graft loss or doubling of serum creatinine .
RESULTS	During the follow-up , 284 patients experienced RGL , and there were 343 cases of graft loss or doubling of serum creatinine .
RESULTS	Those with MS had increased risk for RGL ( relative risk = 1.28 , 95 % confidence interval , 1.00-1 .63 ; p = 0.047 ) , but not for the combined end point .
RESULTS	After adjustment for other known and potential risk factors , MS was no longer associated with increased risk for RGL .
RESULTS	The association between MS and RGL risk was attenuated once adjustment for creatinine was made .
RESULTS	Statin treatment did not reduce the risk for renal end points in RTRs with or without MS.
CONCLUSIONS	MS had no independent association with RGL risk .
CONCLUSIONS	Adjustment for renal function attenuated the association between MS and RGL .

###23684358
OBJECTIVE	To evaluate the MIROX strategy ( 6 FOLFOX7 cycles followed by 6 FOLFIRI cycles ) in patients with resected or resectable metastases from colorectal cancer .
METHODS	This trial compared the MIROX strategy to 12 cycles of simplified LV5FU2 ( sLV5FU2 ) .
METHODS	Chemotherapy was perioperative or adjuvant , at the investigator 's decision , with stratification for this parameter .
METHODS	The primary objective was disease-free survival ( DFS ) .
METHODS	The trial was interrupted in 2004 , following the results of the adjuvant MOSAIC trial showing superiority of FOLFOX4 over LV5FU2 .
RESULTS	Thirty-nine patients were included : 20 in MIROX arm and 19 in sLV5FU2 arm .
RESULTS	Median DFS was higher in the MIROX arm ( not reached versus 24.8 months , P = 0.044 ) .
RESULTS	MIROX regimen was well tolerated ; 5/20 patients experienced a Grade 3 sensoryneuropathy .
CONCLUSIONS	The MIROX strategy demonstrated promising efficacy , but this must be considered cautiously due to the small number of patients included .
CONCLUSIONS	The pragmatic approach adopted for the treatment chronology is feasible .

###23168135
BACKGROUND	Hydroxyapatite-calcium triphosphate ( HCT ) biphasic compounds are known to be efficacious in filling bone voids .
BACKGROUND	No large study to date has assessed their radiographic efficacy in iliac crest voids with computed tomography ( CT ) analysis at a 2-year follow-up .
OBJECTIVE	To assess whether backfilling iliac crest defects with HCT biphasic compound decreases donor site pain and what effect backfilling has on CT appearance of the donor ilium .
METHODS	Prospective randomized clinical trial .
METHODS	Adult patients with spinal disorders undergoing spinal arthrodesis requiring posterior iliac crest bone grafting .
METHODS	Physician-administered visual analog scale ( VAS ) and pre - and postoperative CT analysis was performed .
METHODS	This prospective , randomized , single-blind study followed patients requiring nonstructural posterior iliac crest harvest as part of spinal disorder treatment for 2 years .
METHODS	The harvest technique preserved both cortical tables and their periostea .
METHODS	All patients were randomized to backfill of HCT or no backfill .
METHODS	All patients had a CT of the pelvis immediately postoperative and at the 2-year follow-up .
METHODS	Computed tomography analysis was performed by a board-certified neuroradiologist .
METHODS	Analysis included qualitative assessment of the ilia appearance and defect density quantified in Hounsfield units .
METHODS	All patients completed VAS of their donor site pain ( 0-10 , from low to high ) at 6 weeks and 2 years postoperatively .
RESULTS	Thirty-seven of 40 ( 17 women and 20 men ) subjects returned for a mean 23.9-month follow-up ( range , 22-29 months ) .
RESULTS	The average age was 51.7 years ( range , 27-79 years ) .
RESULTS	Eighteen patients were in the backfill group ( BF ) and 19 were in the control group ( C ) .
RESULTS	There was no statistically significant difference in pain at 6 weeks or 2 years between the two groups .
RESULTS	Bone density significantly decreased from postoperative to 2 years in BF ( implying resorption of HCT and replacement of host bone ) and significantly increased in C ( implying reformation of host bone ) .
RESULTS	Both groups had similar cortical defect repair .
RESULTS	The backfill group had significantly better medullary defect repair ( p < .01 , Fisher exact test ) .
CONCLUSIONS	Backfilling iliac crest voids with HCT biphasic compound does not significantly decrease donor site pain .
CONCLUSIONS	Both the backfilled and control defects reformed bone over the 2-year period , with BF having significantly less medullary defects than C.

###10969114
OBJECTIVE	To determine whether use of the click test , a rapid bedside test of surfactant function , results in earlier and more appropriate surfactant administration in ventilated preterm infants than does usual early rescue treatment .
METHODS	Ventilated preterm infants ( n = 126 ) with inspired oxygen > / = 25 % and mean airway pressure > / = 7 cm H ( 2 ) O were randomized in gestational strata ( < 28 weeks and 28-36 weeks ) to have surfactant therapy determined by the click test or by usual clinical and chest radiograph criteria .
METHODS	The treatment group had the click test performed on a tracheal aspirate as soon as possible after intubation and , if negative or equivocal ( surfactant deficient ) , surfactant was given .
METHODS	The control group had surfactant given as soon as possible based on clinical and chest radiograph diagnoses of respiratory distress syndrome .
RESULTS	In infants of < 28 weeks ' gestation , use of the click test resulted in significantly earlier surfactant therapy ( median time : 50 vs 159 minutes ) and a reduction in the number of infants receiving surfactant ( 48 % vs 79 % ) .
RESULTS	In infants of 28 to 36 weeks ' gestation , there was no difference in time to surfactant ( median time : 300 vs 268 minutes ) or in the number of infants receiving surfactant .
RESULTS	Neonatal morbidity and mortality were similar in click test and control groups .
CONCLUSIONS	Use of the click test in ventilated , extremely premature infants results in significantly earlier and more appropriately targeted administration of surfactant than does early rescue therapy based on clinical and radiograph criteria .
CONCLUSIONS	A randomized trial of targeted early rescue surfactant therapy versus prophylactic surfactant therapy in infants of < 28 weeks ' gestation is warranted .
CONCLUSIONS	The click test has the potential to improve clinical outcomes and reduce costs .

###20035337
OBJECTIVE	Adiponectin gene variations have been associated with obesity .
OBJECTIVE	There are few interventional studies analyzing this association .
OBJECTIVE	The aim of this study was to analyze the effects of a nutritional intervention with Mediterranean-style diet and three ( -4034 A/C , +45 T/G , and +276 G/T ) adiponectin gene variants on 3-year body weight changes in high cardiovascular risk patients .
METHODS	A total of 737 participants , aged 55-80 at high cardiovascular risk were assigned to a low-fat diet or to a Mediterranean-style diet ( MD ) groups , one with high intake of virgin olive oil ( VOO ) and the other with high intake of nuts .
METHODS	Anthropometric parameters were taken at baseline and after 3-year follow-up , and the genotyping of the -4034 A/C , +45 T/G , and +276 G/T polymorphisms was done .
RESULTS	GG genotype of the +45 T/G polymorphism was associated with 3-year higher body weight gain ( B = 1.399 ; B = 0.043 ) .
RESULTS	TT genotype of the +276 G/T polymorphism was linked to the highest 3-year body weight gain in men .
RESULTS	Both Mediterranean diets appeared to reverse this effect ( p for interaction = 0.053 ) .
CONCLUSIONS	Adiponectin gene variation appeared to be associated with 3-year body weight changes in a high cardiovascular risk population .
CONCLUSIONS	This association may be modulated by a nutritional intervention with a Mediterranean-style diet .

###19358495
OBJECTIVE	To explore the main factors influencing the therapeutic effect of acupuncture on neck pain caused by cervical spondylosis , so as to provide references for further increasing the therapeutic effect of acupuncture .
METHODS	One hundred and six cases were randomly divided into an observation group and a control group , 53 cases in each group .
METHODS	The observation group was treated with routine acupuncture at Dazhui ( GV 14 ) , Jingbailao ( Ex-HN 15 ) and Jianzhongshu ( SI 15 ) ; and the control group was treated with sham acupuncture at 1 cm lateral to Bailao ( Ex-HN 15 ) and Jianzhongshu ( SI 15 ) .
METHODS	The needles were retained for 20 min in the two groups and infrared radiation was used for adjuvant treatment in this period .
METHODS	Northwick Park Neck Pain Questionnaire ( NPQ ) was used to assess the patients ' quality of life before and after the treatment .
METHODS	The potential influential factors were analyzed by Logistic regression .
RESULTS	The effective rate was 75.5 % in the observation group and 52.8 % in the control group with a significant difference between the two groups ( P < 0.05 ) .
RESULTS	The Logistic regression analysis indicated that the therapeutic effect in the observation group was superior to the control group ( OR = 2.670 ) , and both the attack frequency and duration of the neck pain will influence the therapeutic effect ( OR = 1.055 and OR = 2.446 ) .
CONCLUSIONS	Acupuncture has a better therapeutic effect on neck pain caused by cervical spondylosis , and patient 's clinical history about attack frequency and duration of neck pain are factors influencing clinical therapeutic effect .

###20974079
BACKGROUND	Throughout the illness trajectory , women with breast cancer experience issues that are related to physical , emotional , and social adjustment .
BACKGROUND	Despite a general consensus that state-of-the-art treatment for breast cancer should include educational and counseling interventions to reduce illness or treatment-related symptoms , there are few prospective , theoretically based , phase-specific randomized , controlled trials that have evaluated the effectiveness of such interventions in promoting adjustment .
OBJECTIVE	The aim of this study is to examine the physical , emotional , and social adjustment of women with early-stage breast cancer who received psychoeducation by videotapes , telephone counseling , or psychoeducation plus telephone counseling as interventions that address the specific needs of women during the diagnostic , postsurgery , adjuvant therapy , and ongoing recovery phases of breast cancer .
METHODS	Primary data from a randomized controlled clinical trial .
METHODS	Three major medical centers and one community hospital in New York City .
METHODS	A total of 249 patients were randomly assigned to either the control group receiving usual care or to one of the three intervention groups .
METHODS	The interventions were administered at the diagnostic , postsurgery , adjuvant therapy , and ongoing recovery phases .
METHODS	Analyses were based on a mixed model analysis of variance .
METHODS	MAIN RESEARCH VARIABLES AND MEASUREMENT : Physical adjustment was measured by the side effects incidence and severity subscales of the Breast Cancer Treatment Response Inventory ( BCTRI ) and the overall health status score of the Self-Rated Health Subscale of the Multilevel Assessment Instrument .
METHODS	Emotional adjustment was measured using the psychological well-being subscale of the Profile of Adaptation to Life Clinical Scale and the side effect distress subscale of BCTRI .
METHODS	Social adjustment was measured by the domestic , vocational , and social environments subscales of the Psychosocial Adjustment to Illness Scale .
RESULTS	Patients in all groups showed improvement over time in overall health , psychological well-being , and social adjustment .
RESULTS	There were no significant group differences in physical adjustment , as measured by side effect incidence , severity , or overall health .
RESULTS	There was poorer emotional adjustment over time in the usual care ( control ) group as compared to the intervention groups on the measure of side effect distress .
RESULTS	For the telephone counseling group , there was a marked decline in psychological well-being from the adjuvant therapy phase through the ongoing recovery phase .
RESULTS	There were no significant group differences in the dimensions of social adjustment .
CONCLUSIONS	The longitudinal design of this study has captured the dynamic process of adjustment to breast cancer , which in some aspects and at various phases has been different for the control and intervention groups .
CONCLUSIONS	Although patients who received the study interventions improved in adjustment , the overall conclusion regarding physical , emotional , and social adjustment is that usual care , which was the standard of care for women in both the usual care ( control ) and intervention groups , supported their adjustment to breast cancer , with or without additional interventions .
CONCLUSIONS	The results are important to evidence-based practice and the determination of the efficacy and cost-effectiveness of interventions in improving patient outcomes .
CONCLUSIONS	There is a need to further examine adjustment issues that continue during the ongoing recovery phase .
CONCLUSIONS	Psychoeducation by videotapes and telephone counseling decreased side effect distress and side effect severity and increased psychological well-being during the adjuvant therapy phase .
CONCLUSIONS	All patients in the control and intervention groups improved in adjustment .
CONCLUSIONS	Adjustment issues are still present in the ongoing recovery phase .

###12589345
BACKGROUND	We have previously shown that omalizumab , a recombinant humanized monoclonal anti-IgE antibody , reduces asthma exacerbations and decreases inhaled corticosteroid ( ICS ) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs .
OBJECTIVE	The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life ( QOL ) .
METHODS	These analyses were part of a multicenter , 52-week , randomized , double-blind , placebo-controlled study assessing the efficacy , safety , and tolerability of subcutaneous omalizumab ( > or = 0.016 mg/kg of IgE [ in international unit per milliliter ] per 4 weeks ) in 525 adults with severe allergic asthma .
METHODS	A 16-week steroid-stable phase was followed by a 12-week steroid-reduction phase and a 24-week double-blind extension phase .
METHODS	The effect of treatment on asthma-related QOL was evaluated by using the Asthma Quality of Life Questionnaire ( AQLQ ) administered at baseline and at weeks 16 , 28 , and 52 .
RESULTS	The 2 treatment groups were comparable in terms of baseline AQLQ scores .
RESULTS	At weeks 16 , 28 , and 52 , omalizumab-treated patients demonstrated statistically significant improvements across all AQLQ domains , as well as in overall score .
RESULTS	Moreover , a greater proportion of patients receiving omalizumab achieved a clinically meaningful improvement in asthma-related QOL during each phase of the study .
RESULTS	Greater than 50 % of both patients and investigators rated treatment similarly with omalizumab as excellent or good compared with less than 40 % of placebo recipients .
CONCLUSIONS	In patients requiring moderate-to-high doses of ICSs for severe allergic asthma , the measurably improved disease control afforded by add-on omalizumab therapy is paralleled by clinically meaningful improvements in asthma-related QOL .

###10224577
OBJECTIVE	Non-obstructive prosthetic valve thrombosis ( PVT ) is a unique subset that features clinical presentation without heart failure , and may be asymptomatic .
OBJECTIVE	Thrombolysis has been accepted for obstructive PVT , but treatment strategies of non-obstructive PVT are controversial .
OBJECTIVE	This study compared the efficacy and safety of thrombolysis and heparin treatment in these patients .
METHODS	Between 1993 and 1998 , 20 consecutive patients were found by multiplane transesophageal echocardiography ( TEE ) to have non-obstructive PVT. TEE was performed for peripheral embolism in two patients , stroke or transient ischemic attack in six , stroke and fever in two , fever in one patient , as a routine postoperative examination in two patients , and for other reasons in seven .
METHODS	Patients were allocated to two groups : group I ( n = 8 ) received streptokinase-mediated fibrinolysis ; group II ( n = 12 ) received intravenous heparin by infusion .
METHODS	Treatment was monitored using TEE .
RESULTS	There was no difference between patient groups with regard to sex , age , type of prosthesis and time since operation , though anticoagulant status was more often inadequate in group II .
RESULTS	By TEE , valve motion was normal in all patients .
RESULTS	In group I , all thrombi were mobile and 5-13 mm in diameter ; in group II , all thrombi but three were mobile and 3-18 mm in diameter .
RESULTS	In group I , thrombolysis was successful in all patients , without complications , within 6-72 h.
RESULTS	In group II , heparin treatment was successful in six patients in 3-32 days .
RESULTS	In one patient , seven days ' of unsuccessful heparin was followed by two months ' successful coumarin therapy .
RESULTS	Among five unsuccessful cases , the thrombus size increased in four ( three became obstructive in 7-35 days ) ; all four patients were switched to fibrinolysis , which was successful without complications in 12-60 h.
RESULTS	The fifth patient developed a stroke after nine days of heparin treatment and was subsequently operated on .
CONCLUSIONS	Non-obstructive PVT may be asymptomatic in one-third of patients .
CONCLUSIONS	Thrombolysis is an efficient and safe treatment , and may be first-line therapy if there is no contraindication .
CONCLUSIONS	Heparin treatment was successful in about one-half of our cases in the presence of sessile or small thrombi and inadequate anticoagulant status .
CONCLUSIONS	In unsuccessful cases , thrombi became obstructive or caused stroke during heparin therapy , the adequate duration of which remains unclear .

###23107655
BACKGROUND	n-3 Polyunsaturated fatty acid ( n-3PUFA ) supplementation in the Gruppo Italiano per lo Studio della Sopravvivenza nell ` Insufficienza Cardiaca ( GISSI-HF ) study reduced total mortality in patients with heart failure ( HF ) , but the mechanism of action is still debated .
BACKGROUND	The hypothesis of the present GISSI-HF substudy was that n-3PUFA may have beneficial effects on cardiac autonomic control .
OBJECTIVE	To evaluate the effect of 1 g/day of n-3PUFA vs placebo on heart rate variability variables , deceleration capacity , and turbulence slope .
METHODS	The GISSI-HF study enrolled patients with HF of any cause and severity .
METHODS	Twenty-four-hour ( range 16-24 hours ) Holter recordings were performed and analyzed in 388 patients at baseline , 3 months , and 12 months .
METHODS	Baseline characteristics were compared by using the ( 2 ) test , t test , or nonparametric Wilcoxon 2-sample test .
METHODS	Changes over time were tested by using the analysis of covariance adjusted by baseline values .
RESULTS	At baseline , 36 % of the patients were older than 70 years , 82 % were men , 92 % presented a left ventricular ejection fraction < 40 % , and 80 % were in New York Heart Association class II .
RESULTS	An increase in mean RR interval , standard deviation of all normal-to-normal RR intervals , very low frequency power ( all P < .05 ) , and turbulence slope ( P = .05 ) was observed after 3 months in the n-3PUFA group compared to the placebo group , independently of the frequency of dietary fish consumption or beta-blocker treatment .
RESULTS	These differences between study groups were no longer statistically significant at 12 months .
RESULTS	A per-protocol analysis in patients compliant with study treatment showed similar results .
CONCLUSIONS	n-3PUFA supplementation partially restored autonomic modulation in patients with chronic HF ; this effect was maximal after 3 months of treatment .

###25451179
BACKGROUND	Breast reconstruction aims to improve health-related quality of life after mastectomy .
BACKGROUND	However , evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking .
METHODS	QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely ( QUEST A ) or highly probable ( QUEST B ) .
METHODS	The primary endpoint for the feasibility phase was the proportion of women who accepted randomization , and it would be considered feasible if patient acceptability rates exceeded 25 per cent of women approached .
METHODS	A companion QUEST Perspectives Study ( QPS ) of patients ( both accepting and declining trial participation ) and healthcare professionals assessed trial acceptability .
RESULTS	The QUEST trials opened in 15 UK centres .
RESULTS	After 18 months of recruitment , 17 patients were randomized to QUEST A and eight to QUEST B , with overall acceptance rates of 19 per cent ( 17 of 88 ) and 22 per cent ( 8 of 36 ) respectively .
RESULTS	The QPS recruited 56 patients and 51 healthcare professionals .
RESULTS	Patient preference was the predominant reason for declining trial entry , given by 47 ( 53 per cent ) of the 88 patients approached for QUEST A and 22 ( 61 per cent ) of the 36 approached for QUEST B. Both trials closed to recruitment in December 2012 , acknowledging the challenges of achieving satisfactory patient accrual .
CONCLUSIONS	Despite extensive efforts to overcome recruitment barriers , it was not feasible to reach timely recruitment targets within a feasibility study .
CONCLUSIONS	Patient preferences for breast reconstruction types and timings were common , rendering patients unwilling to enter the trial .

###14760320
BACKGROUND	A high fasting glucose level may be a marker not only for microvascular complications , but also for macrovascular complications .
BACKGROUND	We evaluated the clinical significance of a high fasting glucose level ( > or = 110 mg/dL ) , detected either at baseline or during follow-up , in the Bezafibrate Infarction Prevention ( BIP ) study .
METHODS	The BIP study was a secondary prevention prospective double-blind study comparing bezafibrate to placebo .
METHODS	A total of 3122 patients with documented coronary artery heart disease who were aged 45 to 74 years and had a total cholesterol level between 180 and 250 mg/dL , low-density lipoprotein cholesterol level < or = 180 mg/dL , a high-density lipoprotein cholesterol level < or = 45 mg/dL , a triglyceride level < or = 300 mg/dL , and a fasting glucose < or = 160 mg/dL were randomized to receive 400 mg of bezafibrate daily or placebo .
RESULTS	The primary end point of the BIP study was fatal myocardial infarction , non-fatal myocardial infarction , or sudden death .
RESULTS	Secondary end points included hospitalization for unstable angina , percutaneous transluminal coronary angioplasty , and coronary artery bypass grafting .
RESULTS	At baseline , 330 patients ( 11 % ) had diabetes mellitus , and 293 patients ( 9 % ) had an impaired fasting blood glucose level ( IFG ) .
RESULTS	During 6.2 years of follow-up , diabetes mellitus developed in 186 patients ( 6 % ) , IFG developed in 366 patients ( 12 % ) , and 62 % of patients remained with normal fasting glucose levels ( NFG ) .
RESULTS	Patients with diabetes mellitus and IFG both at baseline or developing during follow-up had a significantly higher rate of secondary end points than paients with NFG ( P < .0001 ) .
RESULTS	Bezafibrate treatment reduced secondary end points only in patients with NFG ( P = .04 ) .
CONCLUSIONS	Diabetes mellitus and IFG were common in the BIP study and were predictive of a worse clinical outcome that was not attenuated with bezafibrate treatment .

###21076721
BACKGROUND	Percutaneous coronary intervention ( PCI ) - induced myocardial damage is associated with late cardiovascular events .
BACKGROUND	Treatment with atorvastatin before PCI can reduce myocardial damage during the peri-PCI period .
OBJECTIVE	To compare the safety and myocardial effects of different atorvastatin loading doses and dosing frequency before PCI in non-ST segment elevation acute coronary syndrome ( NSTE-ACS ) patients .
METHODS	Eighty NSTE-ACS patients were randomly divided into four groups ( 20 patients per group ) .
METHODS	The control group was given 40 mg atorvastatin each night .
METHODS	The three loading dose groups were treated the same as in the control group , but were given 80 mg atorvastatin 12 h before PCI ( lowload group ) in combination with 40 mg atorvastatin 2 h to 4 h before PCI ( mid-load group ) or 60 mg atorvastatin 2 h to 4 h before PCI ( high-load group ) .
METHODS	All patients underwent PCI within 48 h to 72 h of admission , and received 40 mg atorvastatin for at least one month after PCI .
METHODS	Changes in myocardial markers and highly sensitive C-reactive protein were analyzed .
METHODS	Patients were followed up for 30 days to monitor the incidence of major adverse cardiac events ( MACE ) .
RESULTS	No deaths or revascularizations were recorded .
RESULTS	The incidences of MACE differed significantly between the four groups ( 40 % , 25 % , 10 % and 0 % for the control , low-load , mid-load and high-load groups , respectively ; P < 0.05 ) .
RESULTS	The incidence of MACE and cardiac troponin I level above the normal range , and post-PCI increases in creatine kinase-MB and highly sensitive C-reactive protein were significantly higher in the control group than in the high-load group ( all P < 0.007 ) .
RESULTS	The post-PCI alanine aminotransferase levels in all four groups were significantly higher than the pre-PCI levels , but were within normal ranges .
RESULTS	No myalgia or myasthenia was observed .
CONCLUSIONS	The results of the present study show that short-term atorvastatin loading before PCI was well tolerated and had beneficial myocardial effects in patients with NSTE-ACS .

###19925489
BACKGROUND	Psoriasis is a common and chronic immune-mediated skin disorder , for which there is currently no cure .
BACKGROUND	To our knowledge , this is the first randomized placebo-controlled trial comparing methotrexate and traditional Chinese medicine ( TCM ) in terms of efficacy , safety , and quality of life for the treatment of psoriasis .
METHODS	In total , 61 patients with moderate to severe plaque psoriasis were randomized to receive treatment with methotrexate , TCM or placebo for 6 months .
METHODS	The primary outcome measure was the Psoriasis Area and Severity Index ( PASI ) , and secondary outcome measures were the Physician 's Global Assessment ( PGA ) and the Psoriasis Disability Index ( PDI ) .
RESULTS	In all , 50 patients completed the study and were included in the analysis .
RESULTS	Dropout rates were highest in the TCM group .
RESULTS	Mean PASI change from baseline at 6 months revealed an improvement of 73.9 % of the methotrexate group , 15.1 % of the TCM group and 32.0 % of the placebo group .
RESULTS	There was a significant difference between the three groups , with methotrexate showing greater effectiveness than the other two groups .
RESULTS	No significant difference was found between the TCM and placebo groups .
RESULTS	The methotrexate group also had greater improvement when assessed using the PGA and PDI .
CONCLUSIONS	Our results verify the therapeutic effect of methotrexate for the management of psoriasis .
CONCLUSIONS	Despite widespread belief and use of TCM in Asia for the treatment of psoriasis , we were unable to confirm the efficacy of TCM in this study .

###9108813
BACKGROUND	60 % -90 % of patients with a primary diagnosis of depression also experience symptoms of anxiety , and such patients have a poorer prognosis than those with uncomplicated depression .
BACKGROUND	The serotonin selective reuptake inhibitors have demonstrated efficacy in the treatment of both depression and certain anxiety states .
BACKGROUND	Furthermore , in a metaanalysis of the paroxetine clinical trial database of 2963 patients in whom depression predominated , there was a concomitant reduction in the Hamilton Rating Scale for Depression anxiety factor .
BACKGROUND	The purpose of the present study was to prospectively compare the efficacy of paroxetine and clomipramine in patients specifically selected for coexisting depression and anxiety .
METHODS	This was a 12-week , double-blind , parallel-group trial comparing paroxetine 20-40 mg/day with clomipramine 75-150 mg/day in 1002 patients with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score > or = 20 and a Clinical Anxiety Score ( CAS ) > or = 11 after a 3-7 day placebo run-in period .
RESULTS	Both paroxetine and clomipramine reduced the MADRS and CAS ratings at 2 , 6 , and 12 weeks and at endpoint , with no significant differences between treatment groups at any time point .
RESULTS	CGI severity of illness and global improvement ratings were also similar throughout the trial ; however , there was a statistically significant difference in the CGI efficacy index at 6 weeks and at endpoint , favoring paroxetine ( p = .015 and p = .015 , respectively ) .
RESULTS	Paroxetine resulted in fewer treatment-emergent adverse experiences and related withdrawals than clomipramine ( p = .025 and p = .008 , respectively ) .
RESULTS	The number of serious adverse experiences was not significantly different in the paroxetine group compared with the clomipramine group ( 14 [ 2.8 % ] vs. 27 [ 5.4 % ] ) , but did approach statistical significance ( p = .056 ) .
RESULTS	Anticholinergic-emergent adverse experiences were reported twice as frequently by patients in the clomipramine group as in the paroxetine group ( 36.1 % vs. 18.6 % ) .
CONCLUSIONS	There was no evidence of any significant difference in efficacy between paroxetine and clomipramine in patients with coexisting depression and anxiety .
CONCLUSIONS	However , paroxetine was better tolerated as shown by total treatment-emergent adverse experiences , anticholinergic adverse experiences , and withdrawals due to adverse experiences .

###11099587
OBJECTIVE	Steroid use for the treatment of croup has been supported by several studies , although few have addressed the use of oral dexamethasone for outpatient management .
OBJECTIVE	The efficacy of oral ( PO ) versus intramuscular ( IM ) dosing of dexamethasone in the outpatient treatment of moderate croup are compared in this study .
METHODS	Patients between the ages of 3 months and 12 years with moderate croup ( history or presence of stridor , cyanosis , or retractions ) were eligible for enrollment in this single-blind , prospective study .
METHODS	Patients were randomized to receive a single dose ( 0.6 mg/kg , maximum 8 mg ) of IM or PO dexamethasone .
METHODS	Parents were contacted by phone to assess resolution of symptoms and need for further evaluation .
RESULTS	Two hundred seventy-seven patients were enrolled ( median age : 2.1 years ) .
RESULTS	One hundred thirty-nine patients received IM dexamethasone , and 138 received PO .
RESULTS	At phone follow-up , 141 ( 51 % ) had total resolution of symptoms ( 75 in IM , 66 in PO ) .
RESULTS	Eighty patients ( 29 % ) returned for further evaluation ( 45 in IM , 35 in PO ) .
RESULTS	Twenty-three ( 8 % ) received either more steroids , racemic epinephrine , or admission ( 11 in IM , 12 in PO ) .
CONCLUSIONS	No statistically significant difference was found in the need for subsequent interventions after a single dose of either IM or PO dexamethasone .
CONCLUSIONS	A single PO dose of dexamethasone can be effectively and safely used for the outpatient treatment of moderate croup .

###20485955
OBJECTIVE	Low doses of bupivacaine and lidocaine have been used for spinal anesthesia in outpatient surgery .
OBJECTIVE	The objective of this study was to compare hypobaric solutions of bupivacaine and lidocaine in outpatient anorectal surgery .
METHODS	One hundred and fifty patients , divided in two groups , physical status ASA I-II , scheduled for anorectal surgery in the jackknife position received 3 mL ( 4.5 mg ) of hypobaric 0.15 % bupivacaine or 3 mL ( 18 mg ) of hypobaric 0.6 % lidocaine .
METHODS	The selectivity of the blockade , quality of surgical anesthesia , intensity of the motor blockade , and time for patient recovery were compared .
METHODS	After patients were discharged , daily phone contact was maintained for three days and on the 30th postoperative day .
RESULTS	Adequate surgical blockade was achieved in all patients .
RESULTS	The mean level of cephalad dispersion was L ( 1 ) , ranging from T ( 10 ) - L ( 3 ) , with bupivacaine , and L ( 1 ) , ranging from T ( 11 ) - L ( 2 ) , with lidocaine .
RESULTS	Motor blockade was not observed in 135 patients ( 65 in the bupivacaine group x 70 in the lidocaine group ) .
RESULTS	None of the patients developed hypotension and bradycardia .
RESULTS	The sensorial blockade had a mean duration of 99.1 ( 11.0 ) minutes , with bupivacaine , and 64.1 ( 7.6 ) minutes , with lidocaine ( p < 0.0005 ) .
RESULTS	Post-lumbar puncture headache was not observed in any patient .
CONCLUSIONS	Hypobaric solution of bupivacaine or lidocaine promotes , predominantly , sensorial blockade after subarachnoid injection in patients in the jackknife position .
CONCLUSIONS	Hypobaric lidocaine provides analgesia with the same dispersion of that of bupivacaine , but with shorter duration .
CONCLUSIONS	Hemodynamic stability and the absence of motor blockade represent the major advantages .

###9417523
BACKGROUND	We conducted a multi-institutional , randomized , blinded trial to determine whether the use of platelets from which leukocytes had been removed by a filter or that had been treated with ultraviolet B irradiation would prevent the formation of antiplatelet alloantibodies and refractoriness to platelet transfusions .
METHODS	Patients who were receiving induction chemotherapy for acute myeloid leukemia were randomly assigned to receive one of four types of platelets transfusions : unmodified , pooled platelet concentrates from random donors ( control ) ; filtered , pooled platelet concentrates from random donors ( F-PC ) ; ultraviolet B-irradiated , pooled platelet concentrates from random donors ( UVB-PC ) ; or filtered platelets obtained by apheresis from single random donors ( F-AP ) .
METHODS	All patients received transfusions of filtered , leukocyte-reduced red cells .
RESULTS	Of 530 patients with no alloantibodies at base line , 13 percent of those in the control group produced lymphocytotoxic antibodies and their thrombocytopenia became refractory to platelet transfusions , as compared with 3 percent in the F-PC group , 5 percent in the UVB-PC group , and 4 percent in the F-AP group ( P < or = 0.03 for each treated group as compared with the controls ; there were no significant differences among the treated groups ) .
RESULTS	Lymphocytotoxic antibodies were found in 45 percent of the controls , as compared with 17 to 21 percent in the treated groups ( P < 0.001 for each treated group as compared with the controls ; there were no significant differences among the treated groups ) .
RESULTS	Antibodies against platelet glycoproteins developed in 6 to 11 percent of the patients , with no significant differences among the four groups .
CONCLUSIONS	Reduction of leukocytes by filtration and ultraviolet B irradiation of platelets are equally effective in preventing alloantibody-mediated refractoriness to platelets during chemotherapy for acute myeloid leukemia .
CONCLUSIONS	Platelets obtained by apheresis from single random donors provided no additional benefit as compared with pooled platelet concentrates from random donors .

###19623047
OBJECTIVE	: To examine the predisposing factors for hypoglycemia in medical-surgical intensive care unit patients treated with intensive insulin therapy and to assess its association with mortality .
METHODS	: Nested-cohort study within a randomized controlled trial .
METHODS	: Tertiary care intensive care unit .
METHODS	: Medical-surgical intensive care unit patients with admission blood glucose of > 6.1 mmol/L or 110 mg/dL who were enrolled in a randomized controlled trial comparing intensive insulin therapy with conventional insulin therapy .
METHODS	: None .
METHODS	: Hypoglycemia was defined as blood glucose < or = 2.2 mmol/L or 40 mg/dL and intensive care unit mortality was the primary outcome .
RESULTS	: Among the 523 patients included in the study , hypoglycemia occurred in 84 ( 16 % ) .
RESULTS	Intensive insulin therapy was independently associated with increased risk of hypoglycemia ( adjusted odds ratio , 50.65 ; 95 % confidence interval , 17.36-147 .78 ; p < .0001 ) .
RESULTS	Other variables associated with an increased risk of hypoglycemia included female gender , diabetes , Acute Physiology and Chronic Health Evaluation II , mechanical ventilation , continuous veno-venous hemodialysis , and intensive care unit length of stay .
RESULTS	When adjusted to potential confounders , hypoglycemia was not significantly associated with increased mortality ( adjusted hazard ratio , 1.31 ; 95 % confidence interval , .70 -2.46 ; p = .40 ) .
RESULTS	Patients with admission blood glucose of < or = 10 mmol/L had an increased mortality with hypoglycemia ( adjusted hazard ratio , 4.43 ; 95 % confidence interval , 1.36-14 .44 ; p = .01 ) .
RESULTS	Crude analysis showed significant association of mortality with blood glucose levels of < or = 1.2 mmol/L ( adjusted hazard ratio , 2.92 ; 95 % confidence interval , 1.05-8 .11 ; p = .04 ) .
RESULTS	When adjusted analysis was performed , similar trend was seen but was not statistically significant ( adjusted hazard ratio , 2.56 ; 95 % confidence interval , .85 -7.70 ; p = .10 ) .
CONCLUSIONS	: Our study showed significant increase of hypoglycemia with intensive insulin therapy .
CONCLUSIONS	Although hypoglycemia was not independently associated with increased risk of death , increased mortality could not be excluded with severe hypoglycemia and in patients admitted with blood glucose of < or = 10 mmol/L .

###11296045
OBJECTIVE	To compare the analgesic efficacy of oral tramadol hydrochloride and oral diclofenac sodium for posttonsillectomy pain management .
METHODS	Single-blind ( surgeon and research team members ) , prospective , randomized , controlled clinical trial .
METHODS	Sixty-four patients 11 years and older undergoing bipolar electrocautery tonsillectomy were randomized to either the oral tramadol or the oral diclofenac postoperative pain group .
METHODS	Patients recorded pain levels twice daily for 14 days using a visual analogue scale .
RESULTS	Pain scores for the 14 days were not significantly different between the oral tramadol and oral diclofenac groups .
RESULTS	There were no significant differences in the incidence of postoperative hemorrhage and hospital readmission for uncontrolled pain .
CONCLUSIONS	Oral tramadol can deliver the same analgesic efficacy as oral diclofenac for posttonsillectomy pain relief , which might be beneficial for avoiding the adverse effects of nonsteroidal anti-inflammatory drug therapy .

###19112800
BACKGROUND	Improving the appearance of striae distensae , particularly striae alba , has remained a challenge due to the limited availability of effective and low-risk treatment options .
BACKGROUND	Fractional photothermolysis , a novel concept in skin rejuvenation , has been reported to be effective in the treatment of facial rhytides , acne scars , and surgical scars , but its use in the treatment of striae has not been well studied .
OBJECTIVE	To determine the safety and efficacy of fractional photothermolysis treatment on striae alba and striae rubra .
METHODS	Twenty female patients with striae rubra or striae alba on their abdomen , thighs , or buttocks were enrolled in the study .
METHODS	Lesions were randomized to receive treatment , with site-matched normal control areas .
METHODS	Patients received a total of 6 treatments using a 1550-nm , erbium-doped fiber laser with 2 to 3 weeks of elapsed time between treatments .
METHODS	Clinical response to treatment was assessed at each visit , and at 1-month , 2-month , and 3-month follow-up intervals by the patient and investigator .
METHODS	A comparison evaluation of 8 patients examining photographs of striae at baseline and at the 3-month follow-up evaluation which was assessed by 4 independent dermatologists using the quartile grading scale .
RESULTS	The independent evaluators ' assessments of improvement from photographs of 8 randomly selected patients showed an overall improvement of 26 % to 50 % in 63 % ( 5/8 ) of patients .
RESULTS	A less than 25 % improvement in dyschromia was noted in 50 % ( 4/8 ) of patients .
RESULTS	An improvement in texture of 26 % to 50 % was observed in 50 % ( 4/8 ) of patients .
RESULTS	The clinical responses were independent of age , gender , and skin phototype .
RESULTS	The treatments were tolerated well by all patients with a majority of patients experiencing transient posttreatment erythema and edema .
CONCLUSIONS	Fractional photothermolysis can be effectively and safely used in the treatment of striae rubra and striae alba .

###20700742
OBJECTIVE	To evaluate the effect of an absorbable polyglactin tie ( i.e. , cervical tourniquet ) on postoperative uterine artery blood flow using three-dimensional ( 3D ) power Doppler .
METHODS	Forty-four patients with symptomatic uterine myomas warranting surgical treatment were randomized to either receive absorbable cervical tourniquets group 1 or not group 2 .
METHODS	Resistance index , pulsatility index , and peak systolic velocity of the uterine artery as well as 3D power Doppler study of uterine vascularity in terms of VI , FI , vascularization flow index ( VFI ) were performed preoperatively and at 1 and 3 months , postoperatively .
METHODS	Estimated myoma and uterine volume , operative time were compared in both groups .
RESULTS	No significant difference in the characteristics of myomas , regarding number , size , and location of the largest myoma , between the two studied groups .
RESULTS	No significant differences between the two groups for uterine artery RIs , PIs , and PSV at 1 and 3 months , postoperatively .
RESULTS	The myometrial VI , FI and VFI in the study group were comparable to those in the control group .
RESULTS	No sequential change in FI was noted in either group .
CONCLUSIONS	Absorbable cervical tourniquet during open myomectomy did not compromise uterine perfusion as evaluated by 3D power Doppler study .

###8501418
OBJECTIVE	To explore the possible pathogenetic role of erythropoietin ( EPO ) in the anaemia associated with cyclosporin ( Cs ) in newly diagnosed patients with insulin-dependent diabetes mellitus ( IDDM ) .
METHODS	A multicentre randomized placebo controlled prospective trial of Cs immunosuppression for 12 months in IDDM patients .
METHODS	Patients were recruited from the out-patient clinics of diabetes centres in Europe and Canada .
METHODS	Patients 9-35 years old with a clinical diagnosis of ketonuric IDDM entering less than 6 weeks after diagnosis .
METHODS	188 patients were originally recruited ; 105 patients completed the investigation , 52 patients being treated with Cs , and 53 patients receiving placebo .
METHODS	Random allocation to receive either Cs or placebo .
METHODS	The initial dose of Cs was 10 mg kg-1 BW day-1 .
METHODS	Therapy was maintained for 12 months .
METHODS	B-Haemoglobin , s-creatinine , and s-EPO concentrations were monitored before , during and after therapy with either Cs or placebo .
RESULTS	Blood-haemoglobin ( Hgb ) fell from 8.5 + / - 0.8 to a nadir of 7.8 + / - 0.9 mmol l-1 at 6 months ( P < 0.0001 ) in IDDM patients treated with Cs but not in the placebo patients ( 8.5 + / - 0.8 to 8.8 + / - 0.9 mmol l-1 , NS ) .
RESULTS	The mean serum EPO levels remained unaltered throughout the 6-month period of Cs and placebo therapy .
RESULTS	No significant differences in serum EPO levels between Cs and placebo-treated diabetic patients were found after 6 months of treatment .
CONCLUSIONS	The light anaemia associated with Cs therapy in IDDM patients is not related to an insufficient production of EPO , but is caused by other , as yet unknown mechanisms , unrelated to the nephrotoxic action of this drug .

###16651950
BACKGROUND	Suture knots present several disadvantages in wound closure , because they are tedious to tie and place ischemic demands on tissue .
BACKGROUND	Bulky knots may be a nidus for infection , and they may extrude through skin weeks after surgery .
BACKGROUND	Needle manipulations during knot-tying predispose the surgeon to glove perforation .
BACKGROUND	A barbed suture was developed that is self-anchoring , requiring no knots or slack management for wound closure .
BACKGROUND	The elimination of knot tying may have advantages over conventional wound closure methods .
METHODS	This prospective , randomized , controlled trial was designed to show that the use of barbed suture in dermal closure of the Pfannenstiel incision during nonemergent cesarean delivery surgery produces scar cosmesis at 5 weeks that is no worse than that observed with conventional closure using 3-0 polydioxanone suture .
METHODS	Cosmesis was assessed by review of postoperative photographs by a blinded , independent plastic surgeon using the modified Hollander cosmesis score .
METHODS	Secondary endpoints included infection , dehiscence , pain , closure time , and other adverse events .
RESULTS	The study enrolled 195 patients , of whom 188 were eligible for analysis .
RESULTS	Cosmesis scores did not significantly differ between the barbed suture group and the control group .
RESULTS	Rates of infection , dehiscence , and other adverse events did not significantly differ between the two groups .
RESULTS	Closure time and pain scores were comparable between the groups .
CONCLUSIONS	The barbed suture represents an innovative option for wound closure .
CONCLUSIONS	With a cosmesis and safety profile that is similar to that of conventional suture technique , it avoids the drawbacks inherent to suture knots .

###23464930
OBJECTIVE	A proactive , multifactorial intervention strategy incorporating single-pill amlodipine/atorvastatin ( SPAA ) ( 5-10/10 mg up-titrated to 5-10/20 mg , where approved ) is more effective than physician 's usual care ( UC ) for reducing calculated 10 year coronary heart disease ( CHD ) risk , in patients with hypertension and additional risk factors ( CRUCIAL trial : Curr Med Res Opin 2011 ; 27:821 -- 33 ) .
OBJECTIVE	As SPAA combinations containing atorvastatin 20 mg are not approved in some countries , this post hoc analysis investigated the efficacy and safety of a proactive intervention strategy incorporating low-dose SPAA ( 5/10 or 10/10 mg ) only ( low-dose PI ) versus UC .
METHODS	Of 1461 CRUCIAL participants ( 35-79 years ; hypertension and 3 additional risk factors ; no CHD ; total cholesterol 6.5 mmol/L ) , 105 were prescribed SPAA containing 20 mg atorvastatin and excluded .
METHODS	The primary endpoint was difference between treatment arms in Framingham 10 year CHD risk after 52 weeks ; secondary assessments included difference in calculated CHD risk at Week 16 ; SCORE cardiovascular mortality ( Week 16 and 52 ) ; blood pressure ( BP ) / lipid parameters ; adverse events ( AEs ) .
RESULTS	Baseline BP ( 149.2 / 89.2 vs. 144.3 / 86.5 mmHg ) and calculated CHD risk ( 19.6 % vs. 18.1 % ) were higher for low-dose PI ( n = 655 ) versus UC ( n = 657 ) patients .
RESULTS	Least-squares mean treatment difference ( low-dose PI vs. UC ) in calculated 10 year CHD risk was -26.8 ( 95 % CI : -31.7 , -22.0 ; p < 0.001 ) after 52 weeks ' follow-up and -24.8 ( -29.8 , -19.9 ; p < 0.001 ) after 16 weeks ' follow-up .
RESULTS	Treatment difference in SCORE mortality was -20.1 ( -24.7 , -15.6 ; p < 0.001 ) and -22.4 ( -26.8 , -18.0 ; p < 0.001 ) after 16 and 52 weeks ' follow-up .
RESULTS	Risk calculations are surrogate endpoints and may not translate into actual reductions in cardiovascular events .
RESULTS	Overall , 49.1 % ( low-dose PI ) and 44.0 % ( UC ) reported AEs .
CONCLUSIONS	A proactive , multifactorial approach to cardiovascular management based on low-dose SPAA led to statistically significant improvements in calculated 10 year CHD risk versus physician 's UC , comparable to that reported in the full CRUCIAL trial .
CONCLUSIONS	These data will inform healthcare providers in countries where SPAA ( 5/10 or 10/10 mg ) only are licensed .

###19623601
OBJECTIVE	To determine the long-term tolerability and efficacy of donepezil in patients with vascular dementia ( VaD ) .
METHODS	International , multicentre , open-label , 30-week extension study of two 24-week , randomised , double-blind , placebo-controlled studies .
METHODS	Participants were ambulatory adults ( 59 % female ; mean age , 74.7 + / - 0.3 ) with a diagnosis of possible or probable VaD and without a diagnosis of Alzheimer 's disease , who were medically stable and had completed one of two double-blind studies .
METHODS	All patients received donepezil 5 mg/day for the first 6 weeks , then 10 mg/day ( clinician approval required ) .
METHODS	Assessments were performed at week 6 and every 12 weeks thereafter .
METHODS	The main outcome measure was the Alzheimer 's disease Assessment Scale-cognitive subscale ( ADAS-cog ) .
METHODS	Safety/tolerability measures included adverse events ( AEs ) and physical and laboratory evaluations .
RESULTS	Of 1219 eligible patients , 885 ( 72.6 % ) were enrolled , of which 707 ( 79.9 % ) completed the study ; 127 ( 14.4 % ) patients discontinued due to AEs .
RESULTS	A mean reduction ( 0.6-1 .15 points ) from double-blind study baseline score to week 54 ( end of open-label study ) on the ADAS-cog was observed for patients who received donepezil continuously for 54 weeks .
RESULTS	ADAS-cog scores remained stable in the group that initiated donepezil treatment during the extension study .
RESULTS	Most common donepezil-related AEs were nausea ( occurring in 5.3 % ) and diarrhoea ( 8.8 % ) ; no unexpected AEs attributable to donepezil occurred .
CONCLUSIONS	These data suggest that donepezil improves cognition for up to 54 weeks in patients with VaD .
CONCLUSIONS	Patients initiating donepezil in this extension study did not perform as well on the primary outcome measure as those initiating donepezil in the double-blind study .

###24565090
OBJECTIVE	There are several formulations of propofol available to the anesthesiologist for clinical use .
OBJECTIVE	The aim of this study was to analyze the physicochemical properties , pharmacodynamic effect , and pharmaceutical and clinical equivalence of the reference drug propofol as well as a similar formulation .
METHODS	Sixteen volunteers were enrolled in this randomized , double-blind , and paired study of Diprivan and Propovan formulations .
METHODS	Formulations were given as target-controlled infusion with target concentration of 3.0 g.mL ( -1 ) for 15 minutes .
METHODS	Variables studied were the area under the curve ( AUC ) of the bispectral index ( BIS ) graph regarding time , minimum BIS reached and time to reach it , and recovery time .
METHODS	The two formulations were sent to analysis of particle size of lipid emulsion , surface potential , and active principle quantification .
RESULTS	There was no difference between the formulations when comparing AUC , minimum BIS reached and time to reach it .
RESULTS	The similar formulation recovery time was lower compared to the reference formulation ( eight and 10 min , respectively , p = 0.014 ) .
RESULTS	Mean particle size of lipid emulsion , surface potential , and active ingredient quantification were similar for both formulations .
CONCLUSIONS	There was no clinically significant difference between the use of propofol , reference Diprivan , and the similar Propovan during infusion .
CONCLUSIONS	However , the recovery time was longer with the reference drug .
CONCLUSIONS	Although analysis of both formulations studied show similar results regarding its physicochemical characterization , further studies should be conducted to justify this difference .

###18179482
OBJECTIVE	To evaluate the effectiveness of a home visiting program on health-related measures in a population of older people with poor health status .
METHODS	Randomized , clinical trial .
METHODS	Community-dwelling citizens in The Netherlands .
METHODS	Three hundred thirty people aged 70 to 84 randomly assigned to an intervention group ( n = 160 ) or a control group ( n = 170 ) .
METHODS	Eight home visits , lasting 1 hour or more , with telephone follow-up , over an 18-month period , conducted by experienced home nurses under supervision of a public health nurse ; key elements of the ( systematic ) visits were assessment of health problems and risks , advice , and referral to professional and community services .
METHODS	Self-rated health , functional status , quality of life , and changes in self-reported problems .
RESULTS	No differences were found between the intervention and control group in these and other outcome measures at the end of the intervention period ( 18 months ) .
CONCLUSIONS	The home visiting program did not appear to have any effect on the health status of older people with poor health and are probably not beneficial for such persons .

###19143532
BACKGROUND	Japanese encephalitis is associated with high rates of mortality and disabling sequelae .
BACKGROUND	To date , no specific antiviral has proven to be of benefit for this condition .
BACKGROUND	We attempted to determine the efficacy of oral ribavirin treatment for reducing early mortality among children with Japanese encephalitis in Uttar Pradesh , India .
METHODS	Children ( age , 6 months to 15 years ) who had been hospitalized with acute febrile encephalopathy ( a < or = 2-week history of fever plus altered sensorium ) were tested for the presence of immunoglobulin M antibodies to Japanese encephalitis virus with commercial immunoglobulin M capture enzyme-linked immunosorbent assay .
METHODS	Children with positive results were randomized to receive either ribavirin ( 10 mg/kg per day in 4 divided doses for 7 days ) or placebo syrup through nasogastric tube or by mouth .
METHODS	The primary outcome was early mortality ; secondary outcome measures were early ( at hospital discharge ; normal or nearly normal , independent functioning , dependent , vegetative state , or death ) outcome , time to resolution of fever , time to resumption of oral feeding , duration of hospitalization , and late outcome ( > or = 3 months after hospital discharge ) .
METHODS	The study was double-blind , and analysis was by intention to treat .
RESULTS	A total of 153 patients were enrolled during a 3-year period ; 70 patients received ribavirin , and 83 received placebo .
RESULTS	There was no statistically significant difference between the 2 groups in the early mortality rate : 19 ( 27.1 % ) of 70 ribavirin recipients and 21 ( 25.3 % ) of 83 placebo recipients died ( odds ratio , 1.10 ; 95 % confidence interval , 0.5-2 .4 ) .
RESULTS	No statistically significant differences in secondary outcome measures were found .
CONCLUSIONS	For the dosage schedule used in our study , oral ribavirin has no effect in reducing early mortality associated with Japanese encephalitis .
BACKGROUND	ClinicalTrials.gov identifier : NCT00216268 .

###16061709
BACKGROUND	There is much controversy about the ideal approach to the management of community acquired pneumonia ( CAP ) .
BACKGROUND	Recommendations differ from a pathogen directed approach to an empirical strategy with broad spectrum antibiotics .
METHODS	In a prospective randomised open study performed between 1998 and 2000 , a pathogen directed treatment ( PDT ) approach was compared with an empirical broad spectrum antibiotic treatment ( EAT ) strategy according to the ATS guidelines of 1993 in 262 hospitalised patients with CAP .
METHODS	Clinical efficacy was primarily determined by the length of hospital stay ( LOS ) .
METHODS	Secondary outcome parameters for clinical efficacy were assessment of therapeutic failure on antibiotics , 30 day mortality , duration of antibiotic treatment , resolution of fever , side effects , and quality of life .
RESULTS	Three hundred and three patients were enrolled in the study ; 41 were excluded , leaving 262 with results available for analysis .
RESULTS	No significant differences were found between the two treatment groups in LOS , 30 day mortality , clinical failure , or resolution of fever .
RESULTS	Side effects , although they did not have a significant influence on the outcome parameters , occurred more frequently in patients in the EAT group than in those in the PDT group ( 60 % v 17 % , 95 % CI -0.5 to -0.3 ; p < 0.001 ) .
CONCLUSIONS	An EAT strategy with broad spectrum antibiotics for the management of hospitalised patients with CAP has comparable clinical efficacy to a PDT approach .

###10766682
BACKGROUND	Coenzyme Q10 is commonly used to treat congestive heart failure on the basis of data from several unblinded , subjective studies .
BACKGROUND	Few randomized , blinded , controlled studies have evaluated objective measures of cardiac performance .
OBJECTIVE	To determine the effect of coenzyme Q10 on peak oxygen consumption , exercise duration , and ejection fraction .
METHODS	Randomized , double-blind , controlled trial .
METHODS	University and Veterans Affairs hospitals .
METHODS	55 patients who had congestive heart failure with New York Heart Association class III and IV symptoms , ejection fraction less than 40 % , and peak oxygen consumption less than 17.0 mL/kg per minute ( or < 50 % of predicted ) during standard therapy were randomly assigned .
METHODS	Forty-six patients completed the study .
METHODS	Coenzyme Q10 , 200 mg/d , or placebo .
METHODS	Left ventricular ejection fraction ( measured by radionuclide ventriculography ) and peak oxygen consumption and exercise duration ( measured by a graded exercise evaluation using the Naughton protocol ) with continuous metabolic monitoring .
RESULTS	Although the mean ( + / - SD ) serum concentration of coenzyme Q10 increased from 0.95 + / -0.62 microg/mL to 2.2 + / -1.2 microg/mL in patients who received active treatment , ejection fraction , peak oxygen consumption , and exercise duration remained unchanged in both the coenzyme Q10 and placebo groups .
CONCLUSIONS	Coenzyme Q10 does not affect ejection fraction , peak oxygen consumption , or exercise duration in patients with congestive heart failure receiving standard medical therapy .

###17000959
OBJECTIVE	To conduct systematic long-term follow-up ( LTFU ) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis ( PRISMS ) study to provide up to 8 years of safety , clinical and MRI outcomes on subcutaneous ( s.c. ) interferon ( IFN ) beta-1a in relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	The original cohort of 560 patients was randomized to IFNbeta-1a , 44 or 22 microg three times weekly ( TIW ) or to placebo ; after 2 years , patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years .
METHODS	The LTFU visit was scheduled 7 to 8 years after baseline .
RESULTS	LTFU was attended by 68.2 % of the original PRISMS study cohort ( 382/560 patients ) .
RESULTS	72.0 % ( 275/382 ) were still receiving IFNbeta-1a s.c. TIW .
RESULTS	Patients originally randomized to IFNbeta-1a 44 microg s.c. TIW showed lower Expanded Disability Status Scale progression , relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group .
RESULTS	Brain parenchymal volume did not show differences by treatment group .
RESULTS	Overall , 19.7 % of patients progressed to secondary progressive MS between baseline and LTFU ( 75/381 ) .
RESULTS	No new safety concerns were identified and treatment was generally well tolerated .
CONCLUSIONS	Despite the limitations inherent in any long-term study ( for example , potential differences between returning and nonreturning patients ) , these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed .
CONCLUSIONS	This effect was more apparent in the patients receiving the higher dose .

###24534756
OBJECTIVE	To determine the safety , tolerability and signs of efficacy of MOR103 , a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , in patients with rheumatoid arthritis ( RA ) .
METHODS	Patients with active , moderate RA were enrolled in a randomised , multicentre , double-blind , placebo-controlled , dose-escalation trial of intravenous MOR103 ( 0.3 , 1.0 or 1.5 mg/kg ) once a week for 4weeks , with follow-up to 16weeks .
METHODS	The primary outcome was safety .
RESULTS	Of the 96 randomised and treated subjects , 85 completed the trial ( n = 27 , 24 , 22 and 23 for pooled placebo and MOR103 0.3 , 1.0 and 1.5 mg/kg , respectively ) .
RESULTS	Treatment emergent adverse events ( AEs ) in the MOR103 groups were mild or moderate in intensity and generally reported at frequencies similar to those in the placebo group .
RESULTS	The most common AE was nasopharyngitis .
RESULTS	In two cases , AEs were classified as serious because of hospitalisation : paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject .
RESULTS	Both patients recovered fully .
RESULTS	In exploratory efficacy analyses , subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo .
RESULTS	MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters .
CONCLUSIONS	MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA .
CONCLUSIONS	The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases .
BACKGROUND	NCT01023256 .

###22727979
OBJECTIVE	This study compares the effect of five different training stimuli on sprinting ability and strength production .
METHODS	Sixty physical education students were randomly assigned to five experimental groups : all types of training ( A ) , full-squat ( B ) , parallel-squat ( C ) , loaded countermovement jumping ( D ) and plyometric training ( E ) .
METHODS	Participants in each group trained three days a week for a total of seven weeks .
METHODS	Sprint performance ( 30m ) , maximal dynamic strength ( 1RM ) ( kg ) and velocity of displacement in the concentric phase of full-squat ( m/s ) were measured before and after seven weeks of training .
RESULTS	Pre-training results showed no significant differences among the groups in any of the variables tested .
RESULTS	After seven weeks no significant improvement in sprint performance was found , however , significant improvement in maximal dynamic strength , velocity of displacement were observed in all the groups : combined methods group A ( 20 % ) , heavy-resistance group B ( 11 % ) , power-oriented group C ( 17 % ) , ballistic group D ( 14 % ) and plyometric group E ( 6 % ) .
CONCLUSIONS	A combined training approach using full-squat , parallel-squat , loaded countermovement jumping and plyometric training results in a light improvement in maximal strength , velocity of displacement and sprint performance and the resemblance between movement patterns and the velocity of displacement common to the training and testing methods also contributes to greater performance improvement .

###23110740
BACKGROUND	In this methodology article a thermal threshold testing device designed to test nociception in cats was assessed in six dogs .
BACKGROUND	The purpose of this study was to investigate baseline reproducibility of thermal thresholds obtained by the contact heat testing device , to assess the influence of acepromazine and levomethadone and fenpipramide in dogs .
BACKGROUND	The relationship between change in nociceptive thermal threshold and the opioid 's plasma concentration was determined .
BACKGROUND	Six adult beagle dogs received levomethadone ( 0.2 mg/kg ) , acepromazine ( 0.02 mg/kg ) or saline placebo by intramuscular injection ( IM ) in a randomized cross-over design .
BACKGROUND	Three baseline nociceptive thermal threshold readings were taken at 15 minutes intervals prior to treatment .
BACKGROUND	Further readings were made at 15 , 30 , 45 , 60 , 90 , 120 , 150 , 180 , 210 , 240 , 270 , 300 , 330 , 360 , 420 and 480 minutes after injection .
BACKGROUND	A sedation score was assigned at every reading .
BACKGROUND	Four saline placebo treatments were performed to assess baseline reproducibility .
BACKGROUND	Levomethadone serum concentrations were measured prior and 0.5 , 1 , 2 , 4 , 8 , 12 and 24 hours after drug dosing in a separate occasion .
RESULTS	Acepromazine did not seem to increase the thermal threshold at any time .
RESULTS	After levomethadone there was a significant rise of the thermal threshold between 15 to 120 minutes at serum concentrations between 22.6-46 .3 ng/mL .
RESULTS	Baseline reproducibility was stable in adult beagle dogs .
CONCLUSIONS	The thermal threshold testing system is a suitable device for nociceptive threshold testing in dogs .

###15234277
OBJECTIVE	Sjgren 's syndrome ( SS ) is a systemic autoimmune disease characterized by salivary and lacrimal glandular destruction leading to symptoms of dry mouth and dry eye .
OBJECTIVE	Dryness can also occur in the absence of glandular destruction .
OBJECTIVE	Patients with SS have autoantibodies that bind to muscarinic acetylcholine receptors in the exocrine glands .
OBJECTIVE	Recently , a muscarinic acetylcholine receptor agonist , cevimeline , has been approved for use against symptoms of dry mouth in patients with SS .
OBJECTIVE	In this study , the efficacy of cevimeline in improving symptoms of dry eye was examined .
METHODS	Prospective , randomized , double-blind , multi-center clinical study .
METHODS	Sixty patients were randomly assigned to three groups-placebo ; cevimeline , 20 mg three times daily ; or cevimeline , 30 mg three times daily-and received treatment for 4 weeks .
METHODS	Patients were evaluated before treatment , at week 2 , at the end of treatment , and at the end of a 2 - to 4-week follow-up period .
RESULTS	Compared with the placebo , statistically significant differences were seen with cevimeline , 20 mg three times daily , in subjective symptoms , tear dynamics , condition of the corneoconjunctival epithelium , and global improvement rating .
RESULTS	No difference was found among the three groups regarding the safe use of the drug .
CONCLUSIONS	These results indicate that cevimeline , 20 mg three times daily , is safe and effective in improving symptoms of dry eye in patients with SS .
CONCLUSIONS	Additional studies , with larger patient populations , are needed to further assess the effectiveness of cevimeline for dry eye .

###1998637
OBJECTIVE	To assess the role of external cephalic version ( ECV ) at term , using tocolysis .
METHODS	A randomized controlled trial over a 12 month period .
METHODS	Harare Maternity Hospital , Harare , Zimbabwe .
METHODS	208 women with breech presentation at term were recruited after satisfying eligibility criteria .
METHODS	There were 103 women in the study group and 105 in the control group .
METHODS	At the end of the study a further 104 women were recruited for ECV .
METHODS	ECV attempted after intravenous injection of 10 micrograms of hexaprenaline , using either forward or backward somersault over a maximum period of 5 min .
METHODS	Success rate in terms of presentation during labour , need for caesarean section , and various variables related to fetal outcome .
RESULTS	ECV reduced the frequency of breech presentation during labour from 83 % to 17 % and that of caesarean section from 33 % to 13 % .
RESULTS	There were no troublesome complications from the procedure .
CONCLUSIONS	In carefully selected women with breech presentation , ECV at term using tocolysis , safely reduced the rate of breech presentation in labour and also the caesarean section rate .
CONCLUSIONS	Further research is needed to determine the role of ECV in early labour .

###8409069
OBJECTIVE	The purpose of this study was to determine whether digoxin is effective in patients with chronic , stable mild to moderate heart failure .
BACKGROUND	Digoxin has been a traditional therapy in heart failure , but methodologic limitations in earlier studies have prevented definitive conclusions regarding its efficacy .
METHODS	Withdrawal of digoxin ( placebo group , n = 46 ) or its continuation ( digoxin group , n = 42 ) was performed in a prospective , randomized , double-blind , placebo-controlled multicenter trial of patients with chronic , stable mild to moderate heart failure secondary to left ventricular systolic dysfunction who had normal sinus rhythm and were receiving long-term treatment with diuretic drugs and digoxin .
RESULTS	Patients withdrawn from digoxin therapy showed worsened maximal exercise capacity ( median change in exercise time -96 s ) compared with that of patients who continued to receive digoxin ( change in exercise time +4.5 s ) ( p = 0.003 ) .
RESULTS	Patients withdrawn from digoxin therapy showed an increased incidence of treatment failures ( p = 0.039 ) ( 39 % , digoxin withdrawal group vs. 19 % , digoxin maintenance group ) and a decreased time to treatment failure ( p = 0.037 ) .
RESULTS	In addition , patients who continued to receive digoxin had a lower body weight ( p = 0.044 ) and heart rate ( p = 0.003 ) and a higher left ventricular ejection fraction ( p = 0.016 ) .
CONCLUSIONS	These data provide strong evidence of the clinical efficacy of digoxin in patients with normal sinus rhythm and mild to moderate chronic heart failure secondary to systolic dysfunction who are treated with diuretics .

###22626799
OBJECTIVE	To compare the quality of life ( QOL ) in patients undergoing transhiatal esophagectomy ( THE ) with or without chemotherapy , who were admitted to the Post Graduate Institute of Medical Education and Research , Chandigarh and enrolled in the study , from July 2004 to October 2005 .
METHODS	Thirty patients of esophageal carcinoma by purposive sampling were randomized into two groups i.e. , patients undergoing THE after chemotherapy and patients undergoing THE without chemotherapy .
METHODS	Two QOL questionnaires , one generic i.e. , EORTC-QLQ C-30 ( European Organization for Research and Treatment of Cancer ) and other esophageal cancer-specific i.e. , EORTC OES-18 were utilized to assess the QOL .
RESULTS	Physical functional scales were better in patients , who received neoadjuvant chemotherapy .
RESULTS	The role and social aspects of functional scales deteriorated after completion of treatment in both groups .
RESULTS	This was primarily due to the effect of surgery .
RESULTS	However , they were better from an emotional and cognitive point of value after surgery and radiotherapy .
RESULTS	Fourteen out of 30 patients experienced vomiting and diarrhea due to radiotherapy .
CONCLUSIONS	THE in esophageal carcinoma improves global health scales and majority of symptom scales in all patients .
CONCLUSIONS	QOL improvement in general was better in patients who were administered neoadjuvant chemotherapy along with surgery .

###23475164
OBJECTIVE	The power asymptote ( critical power [ CP ] ) and curvature constant ( W ' ) of the power-duration relationship dictate the tolerance to severe-intensity exercise .
OBJECTIVE	We tested the hypothesis that dietary nitrate supplementation would increase the CP and/or the W ' during cycling exercise .
METHODS	In a double-blind , randomized , crossover study , nine recreationally active male subjects supplemented their diet with either nitrate-rich concentrated beetroot juice ( BR ; 2 250 mLd , 8.2 mmold nitrate ) or a nitrate-depleted BR placebo ( PL ; 2 250 mLd , 0.006 mmold nitrate ) .
METHODS	In each condition , the subjects completed four separate severe-intensity exercise bouts to exhaustion at 60 % of the difference between the gas exchange threshold and the peak power attained during incremental exercise ( 60 % ) , 70 % , 80 % , and 100 % peak power , and the results were used to establish CP and W ' .
RESULTS	Nitrate supplementation improved exercise tolerance during exercise at 60 % ( BR , 696 120 vs PL , 593 68 s ; P < 0.05 ) , 70 % ( BR , 452 106 vs PL , 390 86 s ; P < 0.05 ) , and 80 % ( BR , 294 50 vs PL , 263 50 s ; P < 0.05 ) but not 100 % peak power ( BR , 182 37 vs PL , 166 26 s ; P = 0.10 ) .
RESULTS	Neither CP ( BR , 221 27 vs PL , 218 26 W ) nor W ' ( BR , 19.3 4.6 vs PL , 17.8 3 kJ ) were significantly altered by BR .
CONCLUSIONS	Dietary nitrate supplementation improved endurance during severe-intensity exercise in recreationally active subjects without significantly increasing either the CP or the W ' .

###22162339
OBJECTIVE	Fatigue is an overwhelming rheumatoid arthritis ( RA ) symptom caused by interacting clinical and psychosocial factors .
OBJECTIVE	Cognitive-behavioral therapy ( CBT ) addresses links between thoughts , feelings , and behaviors and uses cognitive restructuring to facilitate behavior changes .
OBJECTIVE	In a randomized controlled trial , a group CBT program for RA fatigue improved fatigue impact , severity , and perceived coping , as well as mood and quality of life .
OBJECTIVE	The aim of this study was to explore the patient perspective of the program and the impact of behavior changes .
METHODS	Ten exit focus groups were held ( 38 patients ) .
METHODS	Transcripts were analyzed by an independent researcher using a hybrid thematic approach , with a subset analyzed by a team member and patient partner .
RESULTS	Three overarching themes were identified .
RESULTS	In `` they made us work it out ourselves '' ( program factors facilitating changes ) , patients spontaneously identified elements of group CBT as pivotal , including guided discovery , the impact of metaphors , and working as a group .
RESULTS	In `` feeling much better about yourself and coping much better '' ( the nature of changes ) , patients described cognitive changes , including enhanced self-efficacy and problem solving , and emotional changes , including being less volatile and fearful of fatigue .
RESULTS	In `` my life has changed so much it 's unbelievable '' ( benefits beyond fatigue ) , patients reengaged in previously abandoned activities , were more active , and enjoyed greater social participation .
CONCLUSIONS	Patients highlighted that CBT elements were key to making behavior changes and that these had far-reaching impacts on their lives .
CONCLUSIONS	This suggests it could be beneficial in clinical practice to incorporate cognitive-behavioral approaches into patient education programs that aim to enhance self-management .

###25427845
BACKGROUND	Since 2007 , the Australian Know your numbers ( KYN ) program has been used in community settings to raise awareness about blood pressure and stroke .
BACKGROUND	In 2011 , the program was modified to include assessment for type 2 diabetes risk .
BACKGROUND	However , it is unclear which approach for assessing diabetes risk in pharmacies is best .
BACKGROUND	We compared two methods : random ( non-fasting ) blood glucose testing ( RBGT ) ; and the Australian type 2 diabetes risk assessment tool ( AUSDRISK ) ; according to 1 ) identification of ` high risk ' participants including head-to-head sensitivity and specificity ; 2 ) number of referrals to doctors ; and 3 ) feasibility of implementation .
METHODS	117 Queensland pharmacies voluntarily participated and were randomly allocated to RBGT and AUSDRISK or AUSDRISK only .
METHODS	Although discouraged , pharmacies were able to change allocated group prior to commencement .
METHODS	AUSDRISK is a validated self-administered questionnaire used to calculate a score that determines the 5-year risk of developing type 2 diabetes .
METHODS	AUSDRISK ( score 12 + ) or RBGT ( 5.6 mmol/I ) indicates a high potential risk of diabetes .
METHODS	Median linear regression was used to compare the two measures .
METHODS	Staff from 68 pharmacies also participated in a semi-structured interview during a site visit to provide feedback .
RESULTS	Data were submitted for 5,483 KYN participants ( 60 % female , 66 % aged > 55 years , 10 % history of diabetes ) .
RESULTS	Approximately half of the participants without existing diabetes were identified as ` high risk ' based on either RBGT or AUSDRISK score .
RESULTS	Among participants who undertook both measures , 32 % recorded a high RBGT and high AUSDRISK .
RESULTS	There was a significant association between RBGT and AUSDRISK scores .
RESULTS	For every one point increase in AUSDRISK score there was a half point increase in RBGT levels ( coefficient 0.55 , 95 % CI : 0.28 , 0.83 ) .
RESULTS	Pharmacy staff reported that AUSDRISK was a simple , low cost and efficient method of assessing diabetes risk compared with RBGT , e.g. since management of sharps is not an issue .
CONCLUSIONS	In a large , community-based sample of Australians about half of the participants without diabetes were at ` high risk ` of developing diabetes based on either AUSDRISK or RBGT results .
CONCLUSIONS	AUSDRISK was considered to be an acceptable method for assessing the risk of diabetes using opportunistic health checks in community pharmacies .

###12401856
BACKGROUND	Muscle cramp is a common complication of haemodialysis .
BACKGROUND	The exact mechanism of this complication is still unknown .
BACKGROUND	Many approaches have been used to relieve the muscle cramping but have had variable effects .
BACKGROUND	One of the possible mechanisms of haemodialysis-associated muscle cramps ( HAMC ) is the disturbance of muscle energy metabolism .
BACKGROUND	Creatine monohydrate can enhance muscle metabolism .
BACKGROUND	We evaluated the clinical effect of creatine monohydrate on HAMC .
METHODS	Ten patients with frequent muscle cramps during haemodialysis were randomly selected into two groups , control and placebo .
METHODS	In a double-blind manner , 12 mg of creatine monohydrate or placebo was given to each patient before each dialysis session for 4 weeks .
METHODS	The incidence of muscle cramp during haemodialysis was compared between the two groups .
METHODS	Dialysis adequacy , haemodynamic status , and side-effects were also evaluated .
METHODS	We continued to observe and compare the patients during a 4-week washout period to verify the effect of creatine monohydrate .
RESULTS	The frequency of symptomatic muscle cramps decreased by 60 % in the creatine monohydrate treatment group ( 6.2 + / -0.8 vs 2.6 + / -1.8 times/4 weeks , P < 0.05 ) during the treatment period .
RESULTS	This decreasing incidence of muscle cramps disappeared in the washout period in the creatine group ( 6.6 + / -1.1 times/4 weeks ) .
RESULTS	There was no difference in the incidence of muscle cramps in the placebo group .
RESULTS	The haematocrit , Kt/V , serum albumin , and haemodynamics remained unchanged in both groups during the treatment and washout periods .
RESULTS	Serum creatinine increased slightly after creatine monohydrate treatment ( 10.7 + / -3.2 vs 12.4 + / -3.2 mg/dl , P < 0.05 ) .
RESULTS	No adverse effect was found in either group during the treatment and washout periods .
CONCLUSIONS	These data suggest that creatine monohydrate can reduce the incidence of HAMC and that it may be a safe agent .

###8040762
OBJECTIVE	To establish rates of skeletal mineralization in children and adolescents , and to identify factors that influence these rates .
METHODS	Three-year observational study .
METHODS	University hospital .
METHODS	Ninety white children , aged 6 to 14 years .
METHODS	Bone mineral density of the radius , spine , and hip was measured at baseline and 3 years later .
METHODS	Physical activity was assessed by questionnaires at 6-month intervals and dietary calcium intake by diet diary 1 day per month for 36 months .
METHODS	Sexual maturation ( Tanner stage ) was determined by an endocrinologist at 6-month intervals , as necessary to classify children as prepubertal , peripubertal , or postpubertal .
RESULTS	Skeletal mineralization accelerated markedly at puberty in the spine ( 0.077 vs 0.027 gm/cm2 per year , peripubertal vs prepubertal ) and greater trochanter ( 0.050 vs 0.027 gm/cm2 per year ) , less markedly in the femoral neck ( 0.047 vs 0.030 gm/cm2 per year ) , and only slightly in the radius .
RESULTS	Nearly one third ( 15 gm ) of the total skeletal mineral in the lumbar spine of adult women ( approximately 52 gm ) was accumulated in the 3 years around the onset of puberty .
RESULTS	Increases in height and weight were the strongest correlates of skeletal mineralization : weight changes were more strongly correlated with trabecular bone sites and changes in height with cortical bone sites .
RESULTS	Increases in calf muscle area were strongly associated with mineralization , particularly in peripubertal children , and physical activity was associated with more rapid mineralization in prepubertal children .
CONCLUSIONS	Puberty has varying effects on skeletal mineralization depending on skeletal site ; trabecular bone is apparently more sensitive to changing hormone concentrations .
CONCLUSIONS	Physical activity and normal growth are also positively associated with skeletal mineralization , also depending on skeletal site and sexual maturation .

###11251138
OBJECTIVE	Small ( 20-gauge ) Tuohy needles have been introduced for epidural steroid injection to optimize patient comfort and decrease the risk of spinal headache .
OBJECTIVE	These needles may be less reliable for indentification of the epidural space than standard 17 - or 18-gauge needles because of their small size .
OBJECTIVE	We prospectively examined the success rate of lumbar epidural steroid placement with loss-of-resistance ( LOR ) technique compared with fluoroscopy confirmation .
METHODS	One hundred patients without history of lumbar spine surgery were enrolled .
METHODS	A 20-gauge Tuohy needle was placed into the epidural space using LOR to saline .
METHODS	Confidence in epidural placement was recorded ( Yes/No ) .
METHODS	Radiologic contrast was then injected and a fluoroscopic epidurogram interpreted by a blinded radiologist for correct placement , ( Yes/No ) separate from the clinical process .
RESULTS	Reliability of LOR was less than our `` gold standard '' of fluoroscopy ( P < .004 ) .
RESULTS	Sensitivity of LOR was 99 % and specificity was 27 % .
RESULTS	Positive and negative predictive values were 92 % and 75 % .
RESULTS	Increased patient age ( > 70 years ) and male sex were associated with poor reliability of LOR ( P < .05 ) .
CONCLUSIONS	In contrast to the reported 99 % success rates for epidural placement of standard 17 - or 18-gauge Tuohy needles , we observed a success rate of 92 % .
CONCLUSIONS	Small-gauge Tuohy needles are technically more difficult to use than larger needles and may require confirmation with fluoroscopy for correct epidural placement , especially in elderly male patients .

###9302365
OBJECTIVE	Approximately 35 % of patients with Graves ' ophthalmopathy do not respond to immunosuppressive treatment .
OBJECTIVE	A possible explanation for this finding is that only patients with active ophthalmopathy respond to immunosuppressive treatment , whereas patients with fibrotic end stage disease do not .
OBJECTIVE	To distinguish between these two groups and to predict the outcome of immunosuppressive treatment , we developed a clinical activity score ( CAS ) based on four of the five classical signs of inflammation and tested its efficacy in a double-blind , prospective study .
METHODS	The CAS was determined by an opthalmologist before , on the day of , and after the start of either oral prednisone or retrobulbar irradiation in 43 patients with moderate to severe Graves ' ophthalmopathy .
METHODS	The therapeutic outcome was determined by a second ophthalmologist unaware of the CAS stores given .
METHODS	Success of treatment was defined as an improvement in NOSPECS class or grade .
RESULTS	Responders ( 22 ) and non-responders ( 21 ) did not differ in age , sex , duration or severity of their Graves ' ophthalmopathy .
RESULTS	The pretreatment CAS , however , was significantly higher in responders than in non-responders .
RESULTS	Twelve of 22 responders and three of 21 non-responders had a CAS > or = 4 ( 55 % vs 14 % ; P < 0.01 ) [ corrected ] .
RESULTS	Using this CAS cut-off point , the accuracy of CAS in predicting the therapeutic outcome was : specificity 86 % , sensitivity 55 % , positive predictive value 80 % , negative predictive value 64 % .
RESULTS	Patients with a CAS > or = 4 had a similar duration of Graves ' ophthalmopathy as patients with a CAS < 4 .
CONCLUSIONS	The clinical activity score has a high predictive value for the outcome of immunosuppressive treatment in Graves ' ophthalmopathy .
CONCLUSIONS	Disease activity , and not disease duration , is the prime determinant of therapeutic outcome .

###18227044
OBJECTIVE	To observe the changes in serum interleukin-8 ( IL-8 ) and tumor necrosis factor-alpha ( TNF-alpha ) after intravenous administration of alanyl-glutamine ( Gln ) in patients with severe pancreatitis .
METHODS	Fifty patients with severe pancreatitis were randomized equally into 2 groups and received standard total parenteral nutrition ( TPN ) with intravenous infusion of Gln or normal saline ( control ) for 1 week .
METHODS	The plasma glutamine level was measured with high-performance liquid chromatography ( HPLC ) in these patients one day before and on day 7 of Gln administration , and the serum IL-8 , TNF-alpha and heat shock protein 70 ( Hsp70 ) were detected with enzyme-linked immunosorbent assay .
RESULTS	On day of Gln administration , the plasma glutamine level in patients of Gln group increased significantly ( P < 0.01 ) , and serum IL-8 and TNF-alpha levels decreased significantly ( P > 0.05 ) in comparison with those of the control group .
RESULTS	The patients receiving Gln supplementation had significantly higher serum albumin level and greater body fat content with shorter hospital stay than those in the control group ( P < 0.05 ) , and the mortality rate in Gln group was also significantly lower ( P < 0.05 ) .
CONCLUSIONS	Gln-enriched TPN may improve the clinical outcomes of patients with severe pancreatitis probably by decreasing serum IL-8 and TNF-alpha levels .

###17131072
BACKGROUND	The laparoscopic approach has emerged in the search for a surgical technique to decrease the morbidity associated with conventional repair of ventral hernias .
BACKGROUND	In this study we aimed to compare the results of our open and laparoscopic ventral hernia repairs prospectively .
METHODS	Between January 2001 and October 2005 , a total of 46 patients diagnosed with ventral hernias ( primary and incisional ) who were admitted to our surgical unit and accepted to be included in this study group were examined .
METHODS	All patients were divided into laparoscopic repair ( n = 23 ) and open repair ( n = 23 ) subgroups in a randomized fashion .
METHODS	The patients ' demographic characteristics , operation times , body mass indices , sizes of fascial defects , hernia locations , durations of hospital stay , presence and degrees of postoperative pain , and postoperative minor and major complications were analysed and compared .
METHODS	All the data were expressed as means + / - SDs .
METHODS	Chi-square and Wilcoxon tests were used for statistical analysis , and P < 0.05 was accepted as a significant statistical value ( SPSS 11.0 for Windows ) .
RESULTS	The demographic characteristics of both groups were similar .
RESULTS	Women predominated , especially in the laparoscopy group ( P < 0.05 ) .
RESULTS	The comparison of the results revealed that the major advantage of laparoscopy was the shortened postoperative hospital stay and the reduced incidence of mesh infection ( P < 0.05 , P < 0.05 ) .
RESULTS	On the other hand , operation time was significantly longer in the laparoscopy group ( P < 0.05 ) .
RESULTS	The major complications encountered in the laparoscopy group were ileus and a missed enterotomy .
RESULTS	The most frequent minor complication was seroma , which was significantly more frequent in the laparoscopy group ( P < 0.05 ) .
RESULTS	Postoperative pain assessment revealed similar results in both groups ( P > 0.05 ) .
CONCLUSIONS	The laparoscopic approach appears to be as effective as open repairs in the treatment of ventral hernias .
CONCLUSIONS	Advanced surgical skill , laparoscopic experience and high technology are mandatory factors for successful ventral hernia repair .

###21689069
BACKGROUND	Bisphosphonates increase the callus size and strength in animal fracture studies .
BACKGROUND	In a human non-randomized pilot study of high tibial osteotomies in knee osteoarthritis , using the hemicallotasis ( HCO ) technique , bisphosphonates shortened the healing time by 12 days .
BACKGROUND	In the present randomized study , we wanted to determine whether a single infusion of zoledronic acid reduces the time to clinical osteotomy healing .
BACKGROUND	Results from the same trial , showing improved pin fixation with zoledronate , have been published separately .
METHODS	46 consecutive patients ( aged 35-65 years ) were operated .
METHODS	At 4 weeks postoperatively , the patients were randomized to an intravenous infusion of either zoledronic acid or sodium chloride .
METHODS	Dual-energy X-ray absorptiometry ( DEXA ) was performed 10 weeks postoperatively .
METHODS	Radiographs were taken at 10 weeks and every second week until there was radiographic and clinical healing .
METHODS	Healing was evaluated blind , with extraction of the external fixator as the endpoint .
METHODS	At 1.5 years , an additional radiograph was taken and the hip-knee-ankle ( HKA ) angle measured to evaluate whether correction had been retained .
RESULTS	All osteotomies healed with no difference in healing time between the groups ( 77 ( SD 7 ) days ) .
RESULTS	Bone mineral density and bone mineral content , as assessed with DEXA , were similar between the groups .
RESULTS	Radiographically , both groups had retained the acquired correction at the 1.5-year follow-up .
CONCLUSIONS	In this randomized comparison , a single infusion of zoledronic acid increased the pin fixation of the external frame but did not shorten the healing time .
CONCLUSIONS	In both groups , the external fixator was extracted almost 2 weeks earlier than in previous studies .
CONCLUSIONS	The early extraction did not cause a loss of correction in either group .

###10754623
BACKGROUND	This study evaluated the antiemetic effectiveness , dose-response , and clinical usefulness of prophylactic ondansetron in the prevention of postoperative nausea and vomiting ( PONV ) in children undergoing strabismus repair .
METHODS	The authors observed 180 children , American Society of Anesthesiologists physical status I or II , 2-12 yr of age , who were undergoing strabismus repair .
METHODS	After induction of anesthesia with halothane and nitrous oxide in oxygen or intravenous thiopental , children received either placebo ( saline ) or intravenous ondansetron in doses of 25 , 50 , 75 , 100 , and 150 / microg/kg ( n = 30 ) .
METHODS	The trachea was intubated and ventilation was controlled .
METHODS	Perioperative analgesic and fluid requirements were standardized .
METHODS	Episodes of nausea and vomiting were recorded for the first 24 h postoperatively .
METHODS	Data such as nonsurrogate ( parental satisfaction scores and duration of postanesthesia care unit stay ) and therapeutic ( numbers needed to prevent and harm ) outcome measures were collected .
RESULTS	The incidences of PONV in the placebo and 25 - , 50 - , 75 - , 100 - , and 150 - , microg/kg ondansetron groups were 83 , 77 , 47 , 30 , 30 , and 27 % , respectively .
RESULTS	The incidence was less in the 75 ( P = 0.002 ) , 100 - ( P = 0.002 ) , and 150-microg/kg ( P < 0.001 ) ondansetron groups compared with placebo .
RESULTS	Duration of stay in the postanesthesia care unit was shorter in the 75 - , 100 - , and 150-microg/kg ondansetron groups ( P < 0.002 ) compared with the placebo group .
RESULTS	Parental assessment scores for the child 's perioperative experience and the positive number needed to prevent PONV were also better and favorable in the 75 - , 100 - , and 150-microg/kg ondansetron groups compared with the placebo group .
RESULTS	The incidence ( P > 0.99 ) and severity ( P = 0.63 ) of PONV were similar in the 75 - and 150-microg/kg ondansetron groups .
RESULTS	Surrogate , nonsurrogate , and therapeutic outcome measures revealed that 75 microg/kg ondansetron provided the same benefits as did 100 and 150 microg/kg .
CONCLUSIONS	The routine prophylactic use of ondansetron at a dose of 75 microg/kg is as effective as 150 microg/kg in preventing PONV and improving the `` true '' outcome measures after strabismus repair in children .

###19037033
OBJECTIVE	To compare efficacy of transobturator tape with tension-free vaginal tape ( TVT ) in the treatment of stress urinary incontinence in women with intrinsic sphincter deficiency .
METHODS	One hundred sixty-four women diagnosed with urodynamic stress incontinence and intrinsic sphincter deficiency with or without concomitant pelvic organ prolapse repair were randomized to receive TVT or transobturator tape .
METHODS	The primary outcome was the presence or absence of urodynamic stress incontinence at 6 months postoperatively .
METHODS	Secondary outcomes were the rate of operative complications , symptomatic stress incontinence requiring further surgery , and quality-of-life questionnaires .
RESULTS	Of 180 women eligible to participate , 164 were enrolled and underwent surgery .
RESULTS	Of the 138 patients assessed at 6 months with urodynamic studies , 14 of 67 ( 21 % ) had urodynamic stress incontinence in the TVT group compared with 32 of 71 ( 45 % ) in the transobturator tape group ( P = .004 ) , with nine women in the transobturator tape group having repeat sling surgery compared with none in the TVT group .
RESULTS	In the intention-to-treat analysis , the incident rate difference for request of repeat surgery was 9.7 % ( 95 % confidence interval [ CI ] 0-19 .9 ) ; repeat surgery would be requested in one of every six transobturator tape procedures compared with 1 of every 16 TVT procedures .
RESULTS	The risk ratio of repeat surgery was 2.6 ( 95 % CI 0.9-9 .3 ) times higher in the transobturator tape group .
CONCLUSIONS	Retropubic TVT is a more effective operation than the transobturator tape sling in women with urodynamic stress incontinence and intrinsic sphincter deficiency .
BACKGROUND	www.actr.org.au , Australian New Zealand Clinical Trials Registry , ACTRN12608000093381
METHODS	I.

###15323064
BACKGROUND	In this analysis , we evaluated the efficacy of the angiotensin II receptor blocker olmesartan medoxomil in reducing systolic blood pressure ( SBP ) and pulse pressure ( PP ) in hypertensive patients .
METHODS	Data from seven randomized , double blind , placebo controlled , 6 - to 12-week efficacy trials of olmesartan 20 mg and 40 mg/day were analyzed to determine changes in trough seated SBP and PP within three cohorts : 1 ) total cohort ( n = 1777 ) ; 2 ) subjects with a wide PP : that is , those with a baseline PP > 55 mm Hg ( n = 917 ) ; and 3 ) a subpopulation of patients with a wide PP and age > or = 65 years ( n = 296 ) .
METHODS	Statistical comparisons used least squares mean values .
RESULTS	In the total cohort , olmesartan 20 and 40 mg/day resulted in mean reductions in SBP of 15.1 and 17.6 mm Hg , respectively ( P < .001 v placebo ) .
RESULTS	In the wide PP cohort , olmesartan resulted in mean reductions in SBP of 17.7 and 22.0 mm Hg and mean reductions in PP of 7.4 Hg and 8.8 mm Hg for the groups receiving 20 and 40 mg/day , respectively ( P < .001 v placebo ) .
RESULTS	In the cohort with wide PP and age > or = 65 years , olmesartan 20 and 40 mg/day produced mean reductions in SBP of 21.8 and 22.5 mm Hg , and PP of 6.7 and 7.6 mm Hg , respectively ( P < .05 v placebo ) .
CONCLUSIONS	Olmesartan significantly reduces SBP and PP , and these reductions are more pronounced in patients with a wide baseline PP .
CONCLUSIONS	In patients with a wide baseline PP and age > or = 65 years , the population at greatest risk for cardiovascular morbidity and mortality , olmesartan reduces PP to an extent similar to that in patients < 65 years of age .

###7882817
OBJECTIVE	To compare the efficacy and safety of controlled-release glipizide ( glipizide-GITS [ gastrointestinal therapeutic system ] ) and immediate-release glipizide in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) .
METHODS	In a multicenter , open-label , randomized , two-way crossover study , 132 patients with NIDDM received daily doses of 5 , 20 , or 40 mg of either glipizide-GITS or immediate-release glipizide for 8 weeks followed by 8 weeks of the alternate formulation .
METHODS	Plasma glucose , serum insulin , C-peptide , and plasma glipizide levels were measured at fasting and post-Sustacal challenge at the end of 1 and 8 weeks of each treatment phase .
METHODS	HbA1c was measured at the end of weeks 7 and 8 of each treatment phase .
RESULTS	Both formulations of glipizide yielded similar mean HbA1c values .
RESULTS	However , mean fasting plasma glucose ( FPG ) levels were significantly lower with glipizide-GITS treatment than with immediate-release glipizide at the end of week 1 ( 11.0 vs. 11.6 mmol/l ; P < 0.01 ) and at the end of the 8-week treatment phase ( 10.9 vs. 11.7 mmol/l ; P < 0.001 ) .
RESULTS	Fasting insulin and C-peptide levels were lower after 5 mg glipizide-GITS vs. immediate-release glipizide .
RESULTS	Glucose responses to Sustacal were similar after both formulations of glipizide ; however , serum insulin ( P < 0.01 ) and C-peptide responses ( P < 0.05 ) were lower with glipizide-GITS than with immediate-release glipizide treatment at the end of the 8-week treatment phase .
RESULTS	Mean plasma glipizide concentrations were stable by the end of week 1 , and the concentrations increased proportionately with dose .
RESULTS	Once-daily Glipizide-GITS provided effective mean glipizide concentrations ( > 50 ng/ml ) 24 h after dosing , even at the lowest ( 5 mg ) dose level .
RESULTS	Both formulations were well tolerated .
CONCLUSIONS	Glipizide-GITS was significantly more effective than immediate-release glipizide in reducing FPG levels .
CONCLUSIONS	Both formulations reduced postprandial plasma glucose levels equally ; however , glipizide-GITS exerted its control in the presence of lower plasma glipizide concentrations in addition to significantly lower insulin and C-peptide levels .
CONCLUSIONS	This suggests that glipizide-GITS improves insulin sensitivity .

###21784351
BACKGROUND	Epidemiologic evidence suggests that nonsteroidal anti-inflammatory drugs ( NSAIDs ) delay onset of Alzheimer 's dementia ( AD ) , but randomized trials show no benefit from NSAIDs in patients with symptomatic AD .
BACKGROUND	The Alzheimer 's Disease Anti-inflammatory Prevention Trial ( ADAPT ) randomized 2,528 elderly persons to naproxen or celecoxib versus placebo for 2 years ( standard deviation = 11 months ) before treatments were terminated .
BACKGROUND	During the treatment interval , 32 cases of AD revealed increased rates in both NSAID-assigned groups .
METHODS	We continued the double-masked ADAPT protocol for 2 additional years to investigate incidence of AD ( primary outcome ) .
METHODS	We then collected cerebrospinal fluid ( CSF ) from 117 volunteer participants to assess their ratio of CSF tau to A ( 1-42 . )
RESULTS	Including 40 new events observed during follow-up of 2,071 randomized individuals ( 92 % of participants at treatment cessation ) , there were 72 AD cases .
RESULTS	Overall , NSAID-related harm was no longer evident , but secondary analyses showed that increased risk remained notable in the first 2.5 years of observations , especially in 54 persons enrolled with cognitive impairment -- no dementia ( CIND ) .
RESULTS	These same analyses showed later reduction in AD incidence among asymptomatic enrollees who were given naproxen .
RESULTS	CSF biomarker assays suggested that the latter result reflected reduced Alzheimer-type neurodegeneration .
CONCLUSIONS	These data suggest a revision of the original ADAPT hypothesis that NSAIDs reduce AD risk , as follows : NSAIDs have an adverse effect in later stages of AD pathogenesis , whereas asymptomatic individuals treated with conventional NSAIDs such as naproxen experience reduced AD incidence , but only after 2 to 3 years .
CONCLUSIONS	Thus , treatment effects differ at various stages of disease .
CONCLUSIONS	This hypothesis is consistent with data from both trials and epidemiological studies .

###24091935
BACKGROUND	Patient activation is linked to better health outcomes and lower rates of health service utilization .
BACKGROUND	The role of patient activation in the rate of hospital readmission within 30 days of hospital discharge has not been examined .
METHODS	A secondary analysis using data from the Project RED-LIT randomized controlled trial conducted at an urban safety net hospital .
METHODS	Data from 695 English-speaking general medical inpatient subjects were analyzed .
METHODS	We used an adapted , eight-item version of the validated Patient Activation Measure ( PAM ) .
METHODS	Total scores were categorized , according to standardized methods , as one of four PAM levels of activation : Level 1 ( lowest activation ) through Level 4 ( highest activation ) .
METHODS	The primary outcome measure was total 30-day post-discharge hospital utilization , defined as total emergency department ( ED ) visits plus hospital readmissions including observation stays .
METHODS	Poisson regression was used to control for confounding .
RESULTS	Of the 695 subjects , 67 ( 9.6 % ) were PAM Level 1 , 123 ( 17.7 % ) were Level 2 , 193 ( 27.8 % ) were Level 3 , and 312 ( 44.9 % ) were Level 4 .
RESULTS	Compared with highly activated patients ( PAM Level 4 ) , a higher rate of 30-day post-discharge hospital utilization was observed for patients at lower levels of activation ( PAM Level 1 , incident rate ratio [ IRR ] 1.75 , 95 % CI ,1.18 to 2.60 ) and ( PAM Level 2 , IRR 1.50 , 95 % CI 1.06 to 2.13 ) .
RESULTS	The rate of returning to the hospital among patients at PAM Level 3 was not statistically different than patients with PAM Level 4 ( IRR 1.30 , 95 % CI , 0.94 to 1.80 ) .
RESULTS	The rate ratio for PAM Level 1 was also higher compared with Level 4 for ED use alone ( 1.68 ( 1.07 to 2.63 ) ) and for hospital readmissions alone ( 1.93 [ 1.22 to 3.06 ] ) .
CONCLUSIONS	Hospitalized adult medical patients in an urban academic safety net hospital with lower levels of Patient Activation had a higher rate of post-discharge 30-day hospital utilization .

###17361524
OBJECTIVE	To observe the clinical efficacy of Chibixiao Recipe ( CBX ) in combination with minocycline and spironolactone in treating rosacea in females .
METHODS	Sixty-eight women with rosacea were randomly assigned to the treated group ( 48 cases ) and the control group ( 20 cases ) , both of which were treated with minocycline and spironolactone taken orally , but to the treated group , the Chinese herbal recipe , CBX was given additionally .
METHODS	Besides , cryotherapy with liquid nitrogen was applied to those with apparent capillary dilatation .
METHODS	The therapeutic course for both groups was 8 weeks .
METHODS	The levels of serum testosterone before and after treatment were determined by radioimmunoassay ( RIA ) , and a 4-month follow-up was conducted .
RESULTS	In the treated group the cure-markedly effective rate was 87.5 % and the recurrent rate was 6.5 % , while in the control group , they were 45.0 % and 41.2 % respectively .
RESULTS	Comparisons in the indexes between the two groups all showed significant difference ( both P < 0.01 ) , with the cure-markedly effective rate higher , and the recurrent rate lower in the treated group .
RESULTS	The serum level of testosterone got lowered in both groups ( P < 0.05 and P < 0.01 ) , but the lowering in the treated group was more significant , showing significance when compared with that in the control group ( P < 0.01 ) .
CONCLUSIONS	CBX in combination with Western medicine has effect in treating rosacea superior to that of Western medicine alone , and could effectively reduce recurrent rate and the serum level of testosterone .
CONCLUSIONS	female rosacea , testosterone , Chibixiao Recipe , minocycline , spironolactone

###18753119
OBJECTIVE	Assess agreement between reported sex and drug use behaviors from audio computer-assisted self-interviewing ( ACASI ) and interviewer-administered questionnaire ( IAQ ) .
METHODS	Participants ( N = 180 ) enrolled in an HIV intervention trial in Russia completed ACASI and IAQ on the same day .
METHODS	Agreement between responses was evaluated .
RESULTS	Of the 13 sex behavior questions , 10 items had excellent agreement ( kappas/ICC 0.80-0 .95 ) and 3 items had moderate agreement ( kappas/ICC 0.59-0 .75 ) .
RESULTS	The 3 drug behavior questions had excellent agreement ( kappas/ICC 0.94-0 .97 ) .
RESULTS	Among HIV-specific questions asked of HIV-positive participants ( n = 21 ) only , 2 items had excellent agreement ( kappas 1.0 ) and 3 items had moderate agreement ( kappas 0.40-0 .71 ) .
CONCLUSIONS	Assessment of drug and sex risk behaviors by ACASI and IAQ had generally strong agreement for the majority of items .
CONCLUSIONS	The lack of discrepancy may result from these Russian subjects ' perception that computers do not ensure privacy .
CONCLUSIONS	Another potential explanatory factor is that both interviews were delivered on the same day .
CONCLUSIONS	These data raise questions as to whether use of ACASI is uniformly beneficial in all settings , and what influence cultural factors have on its utility .

###18180631
OBJECTIVE	Semmes-Weinstein monofilaments are too long for use in parts of the oral cavity .
OBJECTIVE	The present study used shortened Semmes-Weinstein monofilaments to evaluate reliability and spatial differences in the intraoral tactile detection threshold ( TDT ) and the filament-prick pain detection threshold ( FPT ) in healthy volunteers .
METHODS	For practical purposes , classic Semmes-Weinstein monofilaments with 20 different diameters were cut to half their length ( ie , 19 mm ) and the bending forces were measured .
METHODS	Eighteen men and 18 women ( age range , 20 to 33 y ) were recruited to evaluate the reliability and reproducibility of measurements using half-cut monofilaments .
METHODS	The TDT and the FPT were measured on the labial maxillary gingiva , on the palatal maxillary gingiva , and at the anterior tip of the tongue , using a double random staircase method .
RESULTS	According to the forces needed to bend the half-cut filaments , they were renumbered from 2.55 to 6.86 .
RESULTS	There were significant differences of bending force between the half-cut and original monofilaments ( P < 0.001 ) , Using half-cut filaments , the following differences could be detected ; the labial maxillary gingiva had a significantly higher TDT threshold compared with the other test sites ( P < 0.001 ) .
RESULTS	By contrast , the palatal posterior maxillary gingiva had a significantly higher FPT threshold compared with the other test sites ( P < 0.001 ) .
CONCLUSIONS	The present study illustrated that in healthy participants , half-cut Semmes-Weinstein monofilaments reliably and easily assess TDT and FPT intraorally .
CONCLUSIONS	A combined examination of sensory and pain thresholds using these filaments contributes to the clinical examination for orofacial pain .

###17606247
OBJECTIVE	The relationships among primary sources of social support in adolescents ' environments ( family and friends ) and eating behaviors ( fat and fiber consumption ) were examined in a sample of rural adolescents .
METHODS	Cross-sectional baseline health surveys were administered in classrooms as part of a larger randomized trial evaluating a cancer education program .
METHODS	Data were collected in middle schools drawn from 22 rural counties in Virginia and New York .
METHODS	1942 sixth graders with a modal age of 12 years , roughly equal gender distribution , and racially diverse ( 53 % white , 37 % black ) .
METHODS	Variables included a 10-item scale of social support from family and friends for healthy eating , a brief food frequency questionnaire estimating daily grams of fat and fiber intake , and demographics ( age , gender , race ) .
METHODS	Hierarchical multiple regressions and analyses of variance ( ANOVAs ) .
RESULTS	Controlling for demographics , family and friend support were found to significantly predict fat ( P < .05 ) and fiber ( P < .01 ) intake .
RESULTS	Black respondents reported higher support from friends than did white adolescents ( F = 47.49 , P < .01 ) .
CONCLUSIONS	Support for healthful eating was related to healthful dietary practices and differed among racial subgroups .
CONCLUSIONS	Identifying and fostering sources of positive support for healthful eating is critical to developing effective health promotion programs targeting high-risk adolescents .

###10755495
BACKGROUND	Most antidiabetic agents target only 1 of several underlying causes of diabetes .
BACKGROUND	The complementary actions of the antidiabetic agents metformin hydrochloride and rosiglitazone maleate may maintain optimal glycemic control in patients with type 2 diabetes ; therefore , their combined use may be indicated for patients whose diabetes is poorly controlled by metformin alone .
OBJECTIVE	To evaluate the efficacy of metformin-rosiglitazone therapy in patients whose type 2 diabetes is inadequately controlled with metformin alone .
METHODS	Randomized , double-blind , placebo-controlled trial from April 1997 and March 1998 .
METHODS	Thirty-six outpatient centers in the United States .
METHODS	Three hundred forty-eight patients aged 40 to 80 years with a mean fasting plasma glucose level of 12.0 mmol/L ( 216 mg/dL ) , a mean glycosylated hemoglobin level of 8.8 % , and a mean body mass index of 30.1 kg/m2 were randomized .
METHODS	Patients were assigned to receive 2.5 g/d of metformin plus placebo ( n = 116 ) ; 2.5 g/d of metformin plus 4 mg/d of rosiglitazone ( n = 119 ) ; or 2.5 g/d of metformin and 8 mg/d of rosiglitazone ( n = 113 ) for 26 weeks .
METHODS	Glycosylated hemoglobin levels , fasting plasma glucose levels , insulin sensitivity , and beta-cell function , compared between baseline and week 26 , by treatment group .
RESULTS	Glycosylated hemoglobin levels , fasting plasma glucose levels , insulin sensitivity , and beta-cell function improved significantly with metformin-rosiglitazone therapy in a dose-dependent manner .
RESULTS	The mean levels of glycosylated hemoglobin decreased by 1.0 % in the 4 mg/d metformin-rosiglitazone group and by 1.2 % in the 8 mg/d metformin-rosiglitazone group and fasting plasma glucose levels by 2.2 mmol/L ( 39.8 mg/dL ) and 2.9 mmol/L ( 52.9 mg/dL ) compared with the metformin-placebo group ( P < .001 for all ) .
RESULTS	Of patients receiving 8 mg/d of metformin-rosiglitazone , 28.1 % achieved a glycosylated hemoglobin level of 7 % or less [ corrected ] .
RESULTS	Dose-dependent increases in body weight and total and low-density lipoprotein cholesterol levels were observed ( P < .001 for both rosiglitazone groups vs placebo ) .
RESULTS	The proportion of patients reporting adverse experiences was comparable across all groups .
CONCLUSIONS	Our data suggest that combination treatment with once-daily metformin-rosiglitazone improves glycemic control , insulin sensitivity , and beta-cell function more effectively than treatment with metformin alone .

###26040181
OBJECTIVE	Immune response and consequent inflammatory process which originate on ocular surface after a trauma are mediated by cytokines .
OBJECTIVE	Photoablation of corneal stroma performed by excimer laser causes surgically induced trauma .
OBJECTIVE	Interleukin-6 ( IL-6 ) is mostly known as a proinflammatory cytokine .
OBJECTIVE	However , it also has regenerative and anti-inflammatory effects .
OBJECTIVE	It is supposed that this cytokine is likely to play a significant role in the process of corneal wound healing response after photoablation of stroma carried out by laser in situ keratomileusis ( LASIK ) or photorefractive keratectomy ( PRK ) methods .
OBJECTIVE	The aim of this study was to determine and compare the levels of IL-6 in tears before and after treatment with LASIK and PRK methods .
METHODS	The study included 68 shortsighted eyes up to -3.0 diopter sphere , i.e. 198 samples of tears ( per three samples taken from each of the eyes ) , divided into two groups according to the kind of excimer laser intervention performed : the group 1 -- eyes treated by LASIK method ( n = 31 ) , and the group 2 -- eyes treated by the PRK method ( n = 37 ) .
METHODS	The samples of tears were taken from each eye at the following time points : before excimer laser treatment ( 0 h , the control group ) , 1 h after the treatment ( 1 h ) and 24 h after the treatment ( 24 h ) .
METHODS	The patients did not use anti-inflammatory therapy 24 h after the intervention .
METHODS	Tear samples were collected using microsurgical sponge .
METHODS	Level of IL-6 in tear fluid was determined by the flow cytometry method , applying a commercial test kit which allowed cytokine detection from a small sample volume .
METHODS	Results .
METHODS	The values of IL-6 were detectable in 16 % of samples before LASIK treatment and in 30 % of samples before PRK treatment .
METHODS	One h after the treatment IL-6 was detectable in 29 % of samples for the LASIK group and 43 % of samples for the PRK group , and 24 h after the treatment it was detectable in 19 % of samples for the LASIK group and in 57 % of samples for the PRK group .
METHODS	When we analyzed the dynamics of IL76 production in particular groups , we noticed that both in the LASIK and PRK group the number of samples with increased values of IL-6 after 1 h , and after 24 h , was con - siderably larger than the number of samples with decreased values of IL-6 after the intervention .
METHODS	Analyzing the dynamics of IL-6 concentration changes in the 1 h samples vs. 24 h samples there was a statistically significant increase in the number of samples with IL-6 concentration decline in the LASIK group , while at the same time no considerable changes occurred in the PRK group .
METHODS	Comparing average IL-6 values between the two treatment groups in all tear samples at 0 h , 1 h and 24 h after intervention a significantly higher level in the PRK group 24 h after procedure ( p = 0.0031 ) was detected .
CONCLUSIONS	IL-6 level in tears increases 1 h and 24 h after LASIK and PRK treatments .
CONCLUSIONS	This increment is significantly larger 24 h after the treatment with the PRK method than with the LASIK method .
CONCLUSIONS	Changes of IL-6 production levels in tears after excimer laser treatment indicate that this cytokine takes part in the corneal recovery process after stromal photoablation .

###16827637
OBJECTIVE	Gingival overgrowth is a complication of cyclosporine therapy following organ transplantation .
OBJECTIVE	Oral azithromycin is frequently used to treat this complication .
OBJECTIVE	This study examined the efficacy of local azithromycin , in the form of toothpaste , against cyclosporine-induced gingival overgrowth .
METHODS	Twenty stable renal transplanted patients ( 10 men and 10 women ) with gingival hyperplasia were randomly assigned to a test group and a control group .
METHODS	Azithromycincontaining toothpaste had 85 mg azithromycin per gram of toothpaste .
METHODS	Both toothpastes were prescribed b.i.d. , each time using 1.5 cm , for 1 month .
METHODS	All participants received scaling , root planing , polishing , and oral hygiene instructions , at least 4 weeks prior to initiation of the study .
METHODS	Gingival overgrowth index , bleeding on probing , blood urea nitrogen , creatinine , and serum cyclosporine levels were measured at baseline , and then again in the second and fourth weeks after tooth brushing .
METHODS	Patient satisfaction with the toothpastes was evaluated by a visual analogue scale .
METHODS	The stability of clinical responses was followed for 3 months after cessation of the toothpastes .
RESULTS	Gingival overgrowth index decreased significantly in the azithromycin-containing toothpaste group ( from 1.1 + / -0.56 to 0.51 + / -0.47 , P < .001 ) ; however , in the control group , this decrease was not significant ( P = .22 ) .
RESULTS	Bleeding on probing also decreased significantly in patients in the azithromycin-containing toothpaste group compared with controls ( P = .001 ) .
RESULTS	When compared with baseline levels , trough levels of cyclosporine , blood urea nitrogen , and creatinine did not change in either of the groups .
RESULTS	Patients in the control group were more satisfied with the toothpaste than were patients in the test group ( 53 vs 38 ) .
CONCLUSIONS	Azithromycin-containing toothpaste is an effective , simple , and noninvasive treatment for cyclosporine-induced gingival overgrowth .

###19845513
OBJECTIVE	To assess clinical , hemodynamic efficacy and tolerability of a Fixed Atenolol Amlodipine Combination ( FAAC ) in patients with arterial 1-3 degree arterial hypertension as mono - or combination therapy .
METHODS	Antihypertensive efficacy and tolerability of FAAC was investigated in open noncomparative study in 22 centers in 17 cities of Russia on 570 patients ( 246 men , 324 women ) aged 18-65 years ( mean 55,53 +8,55 years ) with 1-3 degree arterial hypertension .
METHODS	Methods of control included office blood pressure ( BP ) measurement , 24-hour BP monitoring , electrocardiography , control of biochemical parameters , assessment of efficacy and tolerability .
RESULTS	Achivement of target BP level at the background of treatment was noted in 401 patients ( 70.35 % ) including 171 ( 30 % ) patients on monotherapy with FAAC and 230 ( 40,35 % ) patients on combination therapy with FAAC and other antihypertensive drug .
RESULTS	After 60 days of monotherapy with FAAC according to data of office measurements systolic BP ( SBP ) decreased from 161.90 + / -14,51 to 129.96 + / -8,76 mm Hg ( p < 0.01 ) , diastolic BP ( DBP ) decreased from 97.61 + / -7.45 to 80.04 + / -6.44 mm Hg ( < 0.01 ) .
RESULTS	Significant lowering of heart rate from 79.25 + / -9.78 to 65.24 + / -7.35 bpm ( p < 0.01 ) was also noted .
RESULTS	After use of combination of FAAC with other antihypertensive drugs according to data of office measurements SBP decreased from 168.24 + / -16,78 to 129.77 + / -9.55 mm Hg ( p < 0.01 ) , DBP decreased from 99.66 + / -10.03 to 81.36 + / -6.51 mm Hg ( < 0.01 ) .
RESULTS	Heart rate decreased from 80.79 + / -10.51 to 66.09 + / -8.37 bpm ( p < 0.01 ) .
RESULTS	According to data of 24-hour BP monitoring significant lowering of mean 24-hour , diurnal and nocturnal systolic and diastolic BP as well as of hypertensive burden were also noted .
RESULTS	No statistically significant dynamics of laboratory parameters was registered during 60 days of therapy with Tenochek .
RESULTS	Tolerability was good in 94 % of patients , adverse events with premature withdrawal of the drug took place in 1.4 % of patients .

###25225951
OBJECTIVE	To investigate the effect of rhubarb combined with early enteral nutrition ( EEN ) on the gastrointestinal function , disease severity and systemic inflammation in patients with severe acute pancreatitis ( SAP ) .
METHODS	A total of 126 patients with SAP were randomly assigned into three groups : parenteral nutrition group , treated with standard solution first and EN 14 days later ; EEN group , treated with EN suspension ; or EEN combined with rhubarb group , treated with rhubarb and then EN 2 h later .
METHODS	The gastrointestinal function , APACHE II scores , the levels of plasma IL-6 , IL-11 , C-reactive proteins ( CRP ) and the liver and kidney functional measures were longitudinally analyzed .
RESULTS	Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays .
RESULTS	The combination of EEN and rhubarb significantly reduced the values of APACHE II scores .
RESULTS	Combination therapies significantly reduced abnormally higher white blood cell ( WBC ) counts and levels of plasma CRP and IL-6 , but increased the levels of plasma IL-11 .
RESULTS	Finally , combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase , aspartate aminotransferase , and creatinine ( Cr ) .
CONCLUSIONS	Combination of EEN and rhubarb significantly improved the gastrointestinal function , inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients .

###8420726
OBJECTIVE	To determine whether a continuous i.v. infusion of cimetidine , a histamine-2 ( H2 ) receptor antagonist , is needed to prevent upper gastrointestinal ( GI ) hemorrhage when compared with placebo and if that usage is associated with an increased risk of nosocomial pneumonia .
OBJECTIVE	Due to the importance of this latter issue , data were collected to examine the occurrence rate of nosocomial pneumonia under the conditions of this study .
METHODS	A multicenter , double-blind , placebo-controlled study .
METHODS	Patients were randomized to receive cimetidine ( n = 65 ) as an iv infusion of 50 to 100 mg/hr or placebo ( n = 66 ) .
METHODS	Intensive care units in 20 institutions .
METHODS	Critically ill patients ( n = 131 ) , all of whom had at least one acute stress condition that previously had been associated with the development of upper GI hemorrhage .
RESULTS	Samples of gastric fluid from nasogastric aspirates were collected every 2 hrs for measurement of pH and were examined for the presence of blood .
RESULTS	Upper GI hemorrhage was defined as bright red blood or persistent ( continuing for > 8 hrs ) `` coffee ground material '' in the nasogastric aspirate .
RESULTS	Baseline chest radiographs were performed and sputum specimens were collected from all patients , and those patients without clear signs of pneumonia ( positive chest radiograph , positive cough , fever ) at baseline were followed prospectively for the development of pneumonia while receiving the study medication .
RESULTS	Cimetidine-infused patients experienced significantly ( p = .009 ) less upper GI hemorrhage than placebo-infused patients : nine ( 14 % ) of 65 cimetidine vs. 22 ( 33 % ) of 66 placebo patients .
RESULTS	Cimetidine patients demonstrated significantly ( p = .0001 ) higher mean intragastric pH ( 5.7 vs. 3.9 ) , and had intragastric pH values at > 4.0 for a significantly ( p = .0001 ) higher mean percentage of time ( 82 % vs. 41 % ) than placebo patients .
RESULTS	Differences in pH variables were not found between patients who had upper GI hemorrhage and those patients who did not , although there was no patient in the cimetidine group who bled with a pH < 3.5 compared with 11 such patients in the placebo group .
RESULTS	Also , the upper GI hemorrhage rate in patients with one risk factor ( 23 % ) was similar to that rate in patients with two or more risk factors ( 25 % ) .
RESULTS	Of the 56 cimetidine-infused patients and 61 placebo-infused patients who did not have pneumonia at baseline , no cimetidine-infused patient developed pneumonia while four ( 7 % ) placebo-infused patients developed pneumonia .
CONCLUSIONS	The continuous i.v. infusion of cimetidine was highly effective in controlling intragastric pH and in preventing stress-related upper GI hemorrhage in critically ill patients without increasing their risk of developing nosocomial pneumonia .
CONCLUSIONS	While the number of risk factors and intragastric pH may have pathogenic importance in the development of upper GI hemorrhage , neither the risk factors nor the intragastric pH was predictive .
CONCLUSIONS	Therefore , short-term administration of continuously infused cimetidine offers benefits in patients who have sustained major surgery , trauma , burns , hypotension , sepsis , or single organ failure .

###24070164
OBJECTIVE	We aimed to evaluate the efficacy and safety of oxaliplatin , 5-fluorouracil ( 5-FU ) , and leucovorin ( LV ) ( FOLFOX-4 ) as second-line treatment in patients with advanced biliary tract cancer ( BTC ) failing gemcitabine/cisplatin first-line chemotherapy .
METHODS	Thirty-seven patients with advanced BTC refractory to gemcitabine/cisplatin chemotherapy were included in the study .
METHODS	FOLFOX-4 regimen consisted of oxaliplatin ( 85 mg/m ( 2 ) ) as a 2-hour infusion on day 1 and 2-hour infusion of LV ( 200 mg/m ( 2 ) / day ) followed by a 5-FU bolus ( 400 mg/m ( 2 ) / day ) and 22-hour infusion of 5-FU ( 600 mg/m ( 2 ) / day ) for two consecutive days every 2 weeks .
METHODS	The primary end point was the time to progression ( TTP ) .
RESULTS	Between January 2009 and January 2012 , a total of 37 patients were enrolled .
RESULTS	The median age was 57 years ( range 32-70 ) and male to female ratio was 21:16 .
RESULTS	Median TTP was 31 months ( 95 % CI 23-36 ) .
RESULTS	The objective response rate was 216 % ( eight partial responses ) , and disease control rate was 622 % ( 15 stable disease ) .
RESULTS	Grade 3-4 toxicities were observed in 378 % of the patients with neutropenia and fatigue being the most frequent ( 216 % ) .
CONCLUSIONS	FOLFOX-4 regimen is a feasible and moderately efficacious second-line chemotherapy for advanced BTC .

###24336948
BACKGROUND	In the Third International Study on Syncope of Uncertain Etiology ( ISSUE-3 ) , cardiac pacing was effective in reducing recurrence of syncope in patients with presumed neurally mediated syncope ( NMS ) and documented asystole but syncope still recurred in 25 % of them at 2 years .
BACKGROUND	We have investigated the role of tilt testing ( TT ) in predicting recurrences .
RESULTS	In 136 patients enrolled in the ISSUE-3 , TT was positive in 76 and negative in 60 .
RESULTS	An asystolic response predicted a similar asystolic form during implantable loop recorder monitoring , with a positive predictive value of 86 % .
RESULTS	The corresponding values were 48 % in patients with non-asystolic TT and 58 % in patients with negative TT ( P = 0.001 versus asystolic TT ) .
RESULTS	Fifty-two patients ( 26 TT + and 26 TT - ) with asystolic neurally mediated syncope received a pacemaker .
RESULTS	Syncope recurred in 8 TT + and in 1 TT - patients .
RESULTS	At 21 months , the estimated product-limit syncope recurrence rates were 55 % and 5 % , respectively ( P = 0.004 ) .
RESULTS	The TT + recurrence rate was similar to that seen in 45 untreated patients ( control group ) , which was 64 % ( P = 0.75 ) .
RESULTS	The recurrence rate was similar between 14 patients with asystolic and 12 with non-asystolic responses during TT ( P = 0.53 ) .
CONCLUSIONS	Cardiac pacing was effective in neurally mediated syncope patients with documented asystolic episodes in whom TT was negative ; conversely , there was insufficient evidence of efficacy from this data set in patients with a positive TT even when spontaneous asystole was documented .
CONCLUSIONS	Present observations are unexpected and need to be confirmed by other studies .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01463358 .

###11759182
OBJECTIVE	The purpose of this double-blind , randomised , placebo-controlled study was to assess the effects of intramuscular and subcutaneous PDRN in favouring the wound-healing process in donor sites of grafts .
METHODS	26 adult patients of both sexes ( 15 males and 11 females ; mean age : 68.2 + / - 16.1 years ) subjected to skin explants due to plastic surgery were eligible to participate in this double-blind , placebo-controlled study .
METHODS	Patients were randomly allocated into the PDRN group ( 14 subjects ) or the placebo group ( 12 subjects ) .
METHODS	PDRN ( 5625 mg/vial ) or placebo were administered by the intramuscular route once daily , associated with a subcutaneous administration of the same dosage form ( 2 vials every 3 days ) for 10 consecutive days .
METHODS	The primary end point for efficacy was the evolution of wound healing in donor sites , which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation .
METHODS	Secondary end points were local subjective symptoms , such as pain and itching , and objective signs such as perilesional erythema and blisters .
METHODS	Signs and symptoms were quantified through an analogue scale .
RESULTS	At day 7 of the treatment period , the difference in percentage of re-epithelialisation was statistically significant ( p < 0.008 ) in favour of the PDRN group .
RESULTS	At the end of the observational period , between-group comparison demonstrated that patients treated with PDRN had a more prompt trophic effect .
RESULTS	No adverse events were reported during the trial .
CONCLUSIONS	The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts .
CONCLUSIONS	This could improve the clinical outcome and decrease the need for additional therapies or hospital stay .

###17591031
BACKGROUND	Stavudine ( d4T ) - containing regimens are associated with a potential for lipoatrophy and dyslipidaemia .
BACKGROUND	We assessed the safety and efficacy of reducing the dose of stavudine compared with switching to tenofovir or maintaining the standard dose of d4T .
METHODS	Clinically stable HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg twice daily with a plasma HIV RNA < 200 copies/ml for at least 6 months were randomized to maintain stavudine 40 mg twice daily ( d4T40 arm ) , to reduce to 30 mg twice daily ( d4T30 arm ) , or to switch from d4T to tenofovir ( TDF arm ) .
RESULTS	Fifty-eight ( 93 % male ) patients were included : 22 in the d4T40 arm , 19 in the d4T30 arm and 17 in TDF arm .
RESULTS	At baseline , median time on d4T was 6 years ( interquartile range [ IQR ] 2.6-7 .1 ) , median age 43 years ( IQR 36-51 ) and median CD4 + T-cell count was 587/mm3 ( IQR 329-892 ) .
RESULTS	At week 24 , median limb fat changes ( g ) were as follows : d4T40 = -182 ( 95 % CI : -469 - -5 ) ; d4T30 = 527 ( 95 % CI : -343 -694 ) ; and TDF = 402 ( 95 % CI : 130-835 ; d4T40 versus TDF , P = 0.0003 ) .
RESULTS	Significant differences between median values of laboratory parameters were detected : triglycerides ( mg/dl ) : d4T40 = 19 ; d4T30 = -23 and TDF = -79 ( d4T40 versus TDF , P = 0.03 ) ; and total cholesterol ( mg/dl ) : d4t40 = 22 , d4T30 = -4 , and TDF = -28 ( d4T40 versus TDF , P = 0.04 ) .
RESULTS	No significant difference was observed in mitochondrial function assessed in peripheral blood mononuclear cells .
CONCLUSIONS	Although both strategies were associated with a trend toward a decrease in plasma lipids and an increase in body fat , the only significant changes were observed among those who switched to tenofovir .

###24093504
OBJECTIVE	This study was designed as a thorough QT ( TQT ) study to evaluate the effects of fluticasone furoate ( FF ) / vilanterol ( VI ) in healthy subjects .
OBJECTIVE	Supportive data from a TQT study conducted with FF are also presented .
METHODS	This was a randomized , placebo - and positive-controlled , double-dummy , double-blind , four-way crossover study , in which healthy subjects ( n = 85 ) were randomized to 7 days of once-daily treatment of FF/VI ( 200/25 or 800/100g ) or placebo or single-dose oral moxifloxacin ( single-blind , 400mg ) .
METHODS	In the supportive TQT study , subjects ( n = 40 ) were randomized to single-dose inhaled FF ( 4000g ) , oral moxifloxacin ( 400mg ) or placebo .
RESULTS	There was a lack of effect of FF/VI ( 200/25g ) on QTcF ( Fridericia 's correction ) ; all time-matched mean differences from baseline relative to placebo ( 0-24h ) were < 5 ms , with upper 90 % confidence intervals ( CI ) of < 10 ms. At 800/100g , FF/VI had no significant clinical effect on QTcF except at 30min postdose when the 90 % CI was > 10 ms [ mean ( 90 % CI ) , 9.6 ms ( 7.2 , 12.0 ) ] .
RESULTS	No effect on QTci ( individually corrected ) was observed at either strength of FF/VI , with mean time-matched treatment differences < 5 ms at all time points [ upper 90 % CIs < 10 ms ( 0-24h ) ] .
RESULTS	Assay sensitivity was confirmed ; moxifloxacin prolonged QTcF and QTci , with time-matched mean differences from baseline relative to placebo of > 10 ms ( 1-8h postdose ) .
CONCLUSIONS	Repeat once-daily dosing of FF/VI ( 200/25g ) , which is the highest therapeutic strength used in phaseIII studies , is not associated with QTc prolongation in healthy subjects .
CONCLUSIONS	Supratherapeutic strength FF/VI ( 800/100g ) demonstrated a small transient effect on QTcF but not on QTci .

###20797449
BACKGROUND	Protocol-eligible subjects may not be candidates for research participation or may decline .
BACKGROUND	To determine factors that affected accrual , we evaluated enrollment in BABY HUG , a multi-center , randomized , placebo-controlled Phase III trial of hydroxyurea ( HU ) in infants with sickle cell anemia .
METHODS	An anonymized registry of potential subjects served as the primary source of data .
METHODS	Study coordinators considered all infants less than age 18 months with a hemoglobin FS diagnosis on newborn screening .
METHODS	Data included the number of potentially eligible subjects , whether parents were approached , and reasons for participating or declining .
RESULTS	Of 1106 potential participants , 28 % were not approached for reasons such as prior poor adherence to clinical care .
RESULTS	Interested families expressed willingness to contribute to medical knowledge ( 51 % ) , hope of being randomized to receive hydroxyurea ( 51 % ) , and desire for closer clinical care ( 51 % ) as reasons for participating .
RESULTS	Disease severity or the perception that their child was ill had less impact on willingness to participate ( 16 % ) .
RESULTS	Parents who declined cited fear of research ( 19 % ) , transportation problems ( 14 % ) , and the demanding nature of the study ( 25 % ) .
RESULTS	Ultimately , 234 ( 21 % ) gave informed consent , with little variability of acceptance rates among sites .
RESULTS	Importantly , the number of subjects enrolled correlated with the number of families that were approached .
RESULTS	Sites that excluded patients based on clinical/psychosocial biases were not more successful in recruiting than those who approached all eligible subjects .
CONCLUSIONS	Large , demanding clinical trials require an adequate pool of potential participants .
CONCLUSIONS	Approaching all potentially eligible patients without predetermined biases enhances success in recruitment .

###21693044
BACKGROUND	Dupuytren 's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function .
BACKGROUND	Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting , however the evidence supporting night splinting is of low quality and equivocal .
METHODS	A multi-centre , pragmatic , open , randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function , finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy .
METHODS	154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only ( n = 77 ) or hand therapy with night-splinting ( n = 77 ) .
METHODS	Primary outcome was self-reported function using the Disabilities of the Arm , Shoulder and Hand ( DASH ) questionnaire .
METHODS	Secondary outcomes were finger range of motion and patient satisfaction .
METHODS	Primary analysis was by intention to treat .
RESULTS	148 ( 96 % ) patients completed follow-up at 12 months .
RESULTS	No statistically significant differences were observed on the DASH questionnaire ( 0-100 scale : adjusted mean diff .
RESULTS	0.66 , 95 % CI - 2.79 to 4.11 , p = 0.703 ) , total extension deficit of operated digits ( degrees : adjusted mean diff 5.11 , 95 % CI -2.33 to 12.55 , p = 0.172 ) or patient satisfaction ( 0-10 numerical rating scale : adjusted mean diff -0.35 , 95 % CI -1.04 to 0.34 , p = 0.315 ) at 1 year post surgery .
RESULTS	Similarly , in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes .
CONCLUSIONS	No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred .
CONCLUSIONS	Given the added expense of therapists ' time , thermoplastic materials and the potential inconvenience to patients having to wear a device , the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits reoccur .
BACKGROUND	The trial was registered as an International Standard Randomised Controlled Trial ISRCTN57079614 .

###25031533
OBJECTIVE	The objective of this pilot trial was to evaluate the safety and efficacy of AKL1 , a patented botanical formulation containing extracts of Picrorhiza kurroa , Ginkgo biloba , and Zingiber officinale , as add-on therapy for patients with chronic obstructive pulmonary disease ( COPD ) and chronic cough .
METHODS	This randomized , double-blind , placebo-controlled trial enrolled male and female patients > 18 years old with COPD and Leicester Cough Questionnaire ( LCQ ) score of < 18 .
METHODS	The 10-week study period comprised a 2-week single-blind placebo run-in period followed by add-on treatment with AKL1 or placebo twice daily for 8 weeks .
METHODS	The primary study endpoint was the change from week 0 to week 8 in cough-related health status , as assessed by the LCQ .
RESULTS	Of 33 patients enrolled , 20 were randomized to AKL1 and 13 to placebo .
RESULTS	Patients included 19 ( 58 % ) men and 14 ( 42 % ) women of mean ( standard deviation [ SD ] ) age of 67 ( 9.4 ) years ; 15 ( 45 % ) patients were smokers and 16 ( 49 % ) were ex-smokers .
RESULTS	The mean ( SD ) change from baseline in LCQ score at 8 weeks was 2.3 ( 4.9 ) in the AKL1 group and 0.6 ( 3.7 ) in the placebo group , with mean difference in change of 1.8 ( 95 % confidence interval : -1.5 to 5.1 ; P = 0.28 ) .
RESULTS	The St George 's Respiratory Questionnaire score improved substantially in the AKL1 treatment group by a mean ( SD ) of -7.7 ( 11.7 ) versus worsening in the placebo group ( +1.5 [ 9.3 ] ) , with mean difference in change of -9.2 ( 95 % confidence interval : -19.0 to 0.6 ; P = 0.064 ) .
RESULTS	There were no significant differences between treatment groups in change from baseline to week 8 in other patient-reported measures , lung function , or the 6-minute walk distance .
CONCLUSIONS	Further study is needed with a larger patient population and over a longer duration to better assess the effects of add-on therapy with AKL1 in COPD .

###22564997
OBJECTIVE	We compared two chemotherapy regimens that included methotrexate ( MTX ) , cisplatin ( CDP ) , and doxorubicin ( ADM ) with or without ifosfamide ( IFO ) in patients with nonmetastatic osteosarcoma of the extremity .
METHODS	Patients age 40 years randomly received regimens with the same cumulative doses of drugs ( ADM 420 mg/m ( 2 ) , MTX 120 g/m ( 2 ) , CDP 600 mg/m ( 2 ) , and IFO 30 g/m ( 2 ) ) but with different durations ( arm A , 44 weeks ; arm B , 34 weeks ) .
METHODS	IFO was given postoperatively when pathologic response to MTX-CDP-ADM was poor ( arm A ) or given in the primary phase of chemotherapy with MTX-CDP-ADM ( arm B ) .
METHODS	End points of the study included pathologic response to preoperative chemotherapy , toxicity , and survival .
METHODS	Given the feasibility of accrual , the statistical plan only permitted detection of a 15 % difference in 5-year overall survival ( OS ) .
RESULTS	From April 2001 to December 2006 , 246 patients were enrolled .
RESULTS	Two hundred thirty patients ( 94 % ) underwent limb salvage surgery ( arm A , 92 % ; arm B , 96 % ; P = .5 ) .
RESULTS	Chemotherapy-induced necrosis was good in 45 % of patients ( 48 % in arm A , 42 % in arm B ; P = .3 ) .
RESULTS	Four patients died of treatment-related toxicity ( arm A , n = 1 ; arm B , n = 3 ) .
RESULTS	A significantly higher incidence of hematologic toxicity was reported in arm B. With a median follow-up of 66 months ( range , 1 to 104 months ) , 5-year OS and event-free survival ( EFS ) rates were not significantly different between arm A and arm B , with OS being 73 % ( 95 % CI , 65 % to 81 % ) in arm A and 74 % ( 95 % CI , 66 % to 82 % ) in arm B and EFS being 64 % ( 95 % CI , 56 % to 73 % ) in arm A and 55 % ( 95 % CI , 46 % to 64 % ) in arm B.
CONCLUSIONS	IFO added to MTX , CDP , and ADM from the preoperative phase does not improve the good responder rate and increases hematologic toxicity .
CONCLUSIONS	IFO should only be considered in patients who have a poor histologic response to MTX , CDP , and ADM.

###24241487
OBJECTIVE	To evaluate the longterm safety of adalimumab administered with or without methotrexate ( MTX ) and compare the efficacy of combination therapy initialization to adalimumab or MTX monotherapy initialization during the open-label extension ( OLE ) of the PREMIER trial ( ClinicalTrials.gov Identifier : NCT00195663 ) .
METHODS	Patients with early rheumatoid arthritis ( RA ) were randomized to receive blinded adalimumab + MTX , adalimumab alone , or MTX alone for 2 years .
METHODS	Following the double-blinded period , patients enrolling in the OLE were given adalimumab for up to 8 additional years , beginning as monotherapy ; investigators could add MTX at their discretion .
METHODS	Results for clinical , functional , and radiographic progression were collected for up to 10 years of treatment .
RESULTS	During the PREMIER OLE , 250/497 patients ( 50.3 % ) completed the trial without new safety signals arising .
RESULTS	Similar proportions of patients discontinued the trial early , although lack of efficacy was reported less often for patients initially randomized to the adalimumab + MTX arm ( 9.3 % ; 21.2 % , and 23.7 % for adalimumab and MTX monotherapies , respectively ) .
RESULTS	Clinical and functional disease control was maintained throughout the trial .
RESULTS	Patients initially randomized to adalimumab + MTX displayed better outcomes , particularly in prevention of radiographic progression ( modified total Sharp score change = 4.0 , 8.8 , 11.0 at Year 10 for the initial adalimumab + MTX , adalimumab , and MTX arms , respectively ) .
CONCLUSIONS	Intensive therapy with adalimumab + MTX combination in patients with early RA has longterm benefits compared to patients initiating with 2-year adalimumab or MTX monotherapy that persists up to 10 years following adalimumab OLE .
CONCLUSIONS	No new safety findings were observed following longterm adalimumab treatment .

###21440700
OBJECTIVE	To determine if constraint-induced movement therapy ( CIMT ) is more effective than bimanual training to improve occupational performance and participation in children with congenital hemiplegia .
METHODS	Single-blind randomized comparison trial with evaluations at baseline , 3 , and 26 weeks .
METHODS	Community facilities in 2 Australian states .
METHODS	Referred sample of children ( N = 64 ; mean age SD , 10.22.7 y , 52 % boys ) were matched for age , sex , side of hemiplegia , and upper-limb function and were randomized to CIMT or bimanual training .
METHODS	After random allocation , 100 % of CIMT and 94 % of the bimanual training group completed the intervention .
METHODS	Each intervention was delivered in day camps ( total 60 h over 10d ) using a circus theme with goal-directed training .
METHODS	Children receiving CIMT wore a tailor-made glove during the camp .
METHODS	The primary outcome was the Canadian Occupational Performance Measure ( COPM ) .
METHODS	Secondary measures included the Assessment of Life Habits ( LIFE-H ) , Children 's Assessment of Participation and Enjoyment , and School Function Assessment .
RESULTS	There were no between-group differences at baseline .
RESULTS	Both groups made significant changes for COPM performance at 3 weeks ( estimated mean difference = 2.9 ; 95 % confidence interval [ CI ] , 2.3-3 .6 ; P < .001 for CIMT ; estimated mean difference = 2.8 ; 95 % CI , 2.2-3 .4 ; P < .001 for bimanual training ) that were maintained at 26 weeks .
RESULTS	Significant gains were made in the personal care LIFE-H domain following CIMT ( estimated mean difference = 0.5 ; 95 % CI , 0.1-0 .9 ; P = .01 ) and bimanual training ( estimated mean difference = 0.6 ; 95 % CI , 0.2-1 .1 ; P = .006 ) .
CONCLUSIONS	There were minimal differences between the 2 training approaches .
CONCLUSIONS	Goal-directed , activity-based , upper-limb training , addressed through either CIMT or bimanual training achieved gains in occupational performance .
CONCLUSIONS	Changes in participation on specific domains of participation assessments appear to correspond with identified goals .

###7993148
BACKGROUND	The primary aim of this article was to explore , in subgroup analyses , whether participants with differing frequencies of aspirin consumption in a randomized , double-blind , placebo-controlled , primary prevention trial had different magnitudes of benefit in the prevention of myocardial infarction .
BACKGROUND	Secondary aims were to identify factors associated with adherence and to examine the relationship of adherence with cardiovascular outcomes in the placebo group .
METHODS	The Physicians ' Health Study randomized 22071 US male physicians who were free of myocardial infarction and cerebrovascular disease at baseline .
METHODS	The average follow-up during the aspirin component of the trial was 60.2 months .
METHODS	Baseline cardiovascular risk factors and adherence to therapy during the trial were assessed by questionnaire ; cardiovascular outcomes were reported by questionnaire and confirmed by record review by an Endpoints Committee .
RESULTS	Several cardiovascular disease risk factors assessed at baseline were related to poor adherence ( taking < 50 % of study tablets ) : cigarette smoking , obesity , lack of exercise , and history of angina .
RESULTS	After adjusting for baseline differences in risk factors , participants in the aspirin group with excellent adherence ( taking at least 95 % of study tablets ) had a statistically significant 51 % reduction in myocardial infarction compared with those with excellent adherence in the placebo group .
RESULTS	Those in the aspirin group with poor adherence had a smaller , non-significant reduction in risk of myocardial infarction ( a 17 % reduction associated with taking < 50 % of study tablets ) .
RESULTS	In the placebo group better adherence was not associated with decreased risk of myocardial infarction , but was strongly associated with decreased risk of death .
CONCLUSIONS	These subgroup data raise the possibility that a less than alternate day aspirin regimen may yield lower benefits in the prevention of myocardial infarction .
CONCLUSIONS	Alternate explanations are that these analyses reflect either the play of chance or effects of uncontrolled confounding since comparisons were no longer randomized .
CONCLUSIONS	Randomized trials are necessary to address the question of frequency of administration of aspirin to achieve optimal benefits in primary prevention of myocardial infarction .

###12059890
BACKGROUND	Inguinal hernia repair is a common surgical procedure , and different types of anesthetic techniques are in use .
BACKGROUND	We wanted to test if preoperative inguinal field block ( IFB ) with ropivacaine would provide benefits in the postoperative period compared with general anesthesia and wound infiltration .
METHODS	Sixty patients scheduled for inguinal hernia repair were randomized to receive general anesthesia with wound infiltration postoperatively , or inguinal field block ( IFB ) before surgery , with no or only light sedation intraoperatively .
METHODS	General anesthesia was induced with midazolam , fentanyl and propofol , maintained with propofol and alfentanil , and supplemented with nitrous oxide in oxygen through a laryngeal mask .
METHODS	The IFB was performed by an anesthesiologist , with 50-60 ml ropivacaine and 5 mg/ml with a dedicated technique .
RESULTS	All significant differences were in favor of the IFB group : less pain ( visual analog scale , verbal pain score ) postoperatively and until day 7 , faster mobilization with less pain , lower analgesic consumption , and higher patient satisfaction .
CONCLUSIONS	Preoperative inguinal field block for hernia repair provides benefits for patients in terms of faster recovery , less pain , better mobilization and higher satisfaction throughout the whole first postoperative week .

###18707985
BACKGROUND	The most effective magnitude and timing of antiplatelet therapy is important in patients with acute ST-elevation myocardial infarction ( STEMI ) .
BACKGROUND	We investigated whether the results of primary coronary angioplasty ( PCI ) can be improved by the early administration of the glycoprotein IIb/IIIa blocker tirofiban at first medical contact in the ambulance or referral centre .
METHODS	We undertook a double-blind , randomised , placebo-controlled trial in 24 centres in the Netherlands , Germany , and Belgium .
METHODS	Between June 29 , 2006 , and Nov 13 , 2007 , 984 patients with STEMI who were candidates to undergo PCI were randomly assigned to either high-bolus dose tirofiban ( n = 491 ) or placebo ( N = 493 ) in addition to aspirin ( 500 mg ) , heparin ( 5000 IU ) , and clopidogrel ( 600 mg ) .
METHODS	Randomisation was by blinded sealed kits with study drug , in blocks of four .
METHODS	The primary endpoint was the extent of residual ST-segment deviation 1 h after PCI .
METHODS	Analysis was by intention to treat .
METHODS	The trial is registered , number ISRCTN06195297 .
RESULTS	936 ( 95 % ) patients were randomly assigned to treatment after a prehospital diagnosis of myocardial infarction in the ambulance .
RESULTS	Median time from onset of symptoms to diagnosis was 76 min ( IQR 35-150 ) .
RESULTS	Mean residual ST deviation before PCI ( 10.9 mm [ SD 9.2 ] vs 12.1 mm [ 9.4 ] , p = 0.028 ) and 1 h after PCI ( 3.6 mm [ 4.6 ] vs 4.8 mm [ 6.3 ] , p = 0.003 ) was significantly lower in patients pretreated with high-bolus dose tirofiban than in those assigned to placebo .
RESULTS	The rate of major bleeding did not differ significantly between the two groups ( 19 [ 4 % ] vs 14 [ 3 % ] ; p = 0.36 ) .
CONCLUSIONS	Our finding that routine prehospital initiation of high-bolus dose tirofiban improved ST-segment resolution and clinical outcome after PCI , emphasises that further platelet aggregation inhibition besides high-dose clopidogrel is mandated in patients with STEMI undergoing PCI .

###16669963
BACKGROUND	Although laxatives are a first-line treatment for constipation , there are few randomized placebo-controlled trials assessing their efficacy .
OBJECTIVE	To determine the effect and safety of oral bisacodyl on stool frequency and consistency in patients with idiopathic constipation .
METHODS	55 patients ( age 19-89 years ) with idiopathic constipation were recruited from eight primary care practices and randomized to receive bisacodyl , 10 mg once daily , or placebo , on three successive days following a 3-day run-in period .
METHODS	Patients recorded stool frequency and consistency and adverse events .
METHODS	RESULTS ; In each treatment group , 27 patients were evaluable for efficacy .
METHODS	The mean number of stools per day was significantly greater in the bisacodyl-treated group ( 1.8 / day ) compared with placebo ( 0.95 / day ) over the treatment phase ( P = 0.0061 ) .
METHODS	Mean stool consistency score improved from ` hard ' ( run-in ) to between ` soft ' and ` well-formed ' during bisacodyl treatment , remaining between ` moderately hard ' and ` hard ' for placebo treatment ( P < 0.0001 ) .
METHODS	The investigator 's global efficacy score was superior for the bisacodyl group compared with placebo .
METHODS	Both treatments were well tolerated .
METHODS	Serum electrolyte levels and incidence of adverse events were comparable between treatment groups .
CONCLUSIONS	Bisacodyl is effective and safe in improving stool frequency and consistency in acute treatment of idiopathic constipation .

###16959466
OBJECTIVE	To test the efficacy of an information intervention upon emotional recovery following coronary artery bypass surgery .
METHODS	Randomized trial .
METHODS	Video information was combined with individualized information sessions carried out by nurses at admission and at discharge from the hospital .
METHODS	The video was shown pre-operatively and again during the session at admission .
METHODS	Patients were helped to express their questions and worries and congruent information and support was provided .
METHODS	Control group patients received standardized information and no video .
METHODS	Recordings were made at baseline , discharge from hospital and during a 2 years follow-up period .
RESULTS	One hundred and nine patients were randomized to the intervention or the control groups .
RESULTS	A MANOVA was used to test of the variance of the outcome variables at each time point .
RESULTS	At discharge intervention patients reported less anxiety ( p = 0.046 ) and better subjective health ( p = 0.005 ) .
RESULTS	They reported better subjective health during the whole follow-up period ( 0.040 > or = p > or = 0.000 ) , less anxiety up to 1 year ( 0.042 > or = p > or = 0.004 ) , and less depression from 6 months to 2 years following discharge ( 0.023 > or = p > or = 0.004 ) .
CONCLUSIONS	The effects of the intervention probably relate to the combined use of the video and patient centered information sessions .
CONCLUSIONS	The intervention can easily be implemented in clinical practice and nurses strongly identified with its principles .

###22767424
BACKGROUND	Findings regarding the relationship between patient treatment preference and treatment outcome are mixed .
BACKGROUND	This is a secondary data analysis investigating the relationship between treatment preference , and symptom outcome and attrition in a large two-phase depression treatment trial .
METHODS	Patients met DSM-IV criteria for chronic forms of depression .
METHODS	Phase I was a 12-week , nonrandomized , open-label trial in which all participants ( n = 785 ) received antidepressant medication ( s ) ( ADM ) .
METHODS	Phase I nonremitters were randomized to Phase II , in which they received 12 weeks of either cognitive-behavioral system of psychotherapy ( CBASP ) + ADM ( n = 193 ) , brief supportive psychotherapy ( BSP ) + ADM ( n = 187 ) , or ADM only ( n = 93 ) .
METHODS	Participants indicated their treatment preference ( medication only , combined treatment or no preference ) at study entry .
METHODS	Symptoms were measured at 2-week intervals with the 24-item Hamilton Rating Scale for Depression ( HAM-D ) .
RESULTS	A large majority of patients reported a preference for combined treatment .
RESULTS	Patients who preferred medication only were more likely to endorse a chemical imbalance explanation for depression , whereas those desiring combined treatment were more likely to attribute their depression to stressful experiences .
RESULTS	In Phase I , patients who expressed no treatment preference showed greater rates of HAM-D symptom reduction than those with any preference , and patients with a preference for medication showed higher attrition than those preferring combined treatment .
RESULTS	In Phase II , baseline treatment preference was not associated with symptom reduction or attrition .
CONCLUSIONS	Treatment preferences may moderate treatment response and attrition in unexpected ways .
CONCLUSIONS	Research identifying factors associated with differing preferences may enable improved treatment retention and response .

###16260701
OBJECTIVE	The combination of interferon alfa ( IFNalpha ) and isotretinoin has shown a direct antiproliferative effect on human melanoma cell lines , but it remained unclear whether this combination is more effective than IFNalpha alone in patients with metastatic melanoma .
OBJECTIVE	We evaluated safety and efficacy of IFNalpha and isotretinoin compared with IFNalpha alone as adjuvant treatment in patients with primary malignant melanoma stage IIA and IIB .
METHODS	In a prospective , randomized , double-blind , placebo-controlled trial , 407 melanoma patients in stage IIA ( 301 patients ) and IIB ( 106 patients ) were randomly assigned to either IFNalpha and isotretinoin ( isotretinoin group ; 206 patients ) or IFNalpha and placebo ( placebo group ; 201 patients ) after excision of the primary tumor .
METHODS	IFNalpha was administered three times a week at a dose of 3 million units subcutaneously for 24 months .
METHODS	Isotretinoin at a dose of 20 mg for patients < or = 73 kg , 30 mg for patients greater than 73 kg , or placebo daily for 24 months .
RESULTS	A scheduled interim analysis revealed no significant differences in survival rates , with the isotretinoin group and the placebo group showing 5-year disease-free survival rates of 55 % ( 95 % CI , 46 % to 65 % ) and 67 % ( 95 % CI , 59 % to 75 % ) , respectively , and overall 5-year survival rates of 76 % ( 95 % CI , 67 % to 84 % ) and 81 % ( 95 % CI , 74 % to 88 % ) , respectively .
RESULTS	The trial was stopped for futility .
CONCLUSIONS	The addition of isotretinoin to an adjuvant treatment of low-dose IFNalpha in patients with stage IIA and IIB melanoma had no significant effect on disease-free or overall survival and is therefore not recommended .

###18277347
OBJECTIVE	The aim of the study was to assess by what percentage the use of transvaginal ultrasound ( TV , curettage ) following voluntary interruption of pregnancy ( IVG ) reduces the incidence of haemorrhagic events resulting from incomplete drainage of the cavity during the first trimester of gestation .
METHODS	The present is a randomized prospective study involving 720 women who in the period between January 2005 and January 2007 underwent drainage of the cavity during the first trimester of gestation .
METHODS	The study group involved 360 women who were submitted to TV ultrasound using the Toshiba JustVision 400 system at the end of the surgical procedure .
METHODS	The control group also numbered 360 women ; they , by contrast , did not undergo ultrasound examination at the end of surgery .
METHODS	In the study group , in those cases in which the ultrasound examination carried out with a TV probe highlighted an endometrial rima of thickness 8 mm , recurettage was carried out .
METHODS	Patients then underwent further gynecological and ultrasound control examination , 5-8 days after the surgical procedure .
RESULTS	The index of complications overall was 3.2 % .
RESULTS	Retained products of conception were encountered in 2 women in the study group ( 0.5 % ) and in 13 women from the control group ( 3.6 % , P < 0.05 ) .
RESULTS	Vaginal bleeding requiring hospitalization was observed in 2 women in the study group ( 0,5 % ) against 6 in the control group ( 1.6 % , P = 0.2 ) .
RESULTS	Cases of endometritis were diagnosed in only one woman in the study group ( 0.3 % ) against 5 in the control group ( 1.4 % ) and uterine perforation occurred in only one woman in the control group versus no case in the study group .
RESULTS	There were no cases of retained products of conception in women presenting endometrial thickness < 8 mm , a dimension obtained with the aid of ultrasound at the end of the surgical procedure .
CONCLUSIONS	The use of ultrasound examination , carried out with the aid of a TV probe immediately following uterine drainage during the first trimester of pregnancy , may considerably reduce the incidence both of post-IVG haemorrhages due to incomplete curettage and of the total number of complications .
CONCLUSIONS	Evaluation of endometrial thickness is of crucial importance .
CONCLUSIONS	If this turns out to be = 8 mm at the end of the surgical procedure , recurettage of the uterine cavity is indicated .

###24886206
BACKGROUND	Adolescent smoking is still highly prevalent in Denmark .
BACKGROUND	One in four 13-year olds indicates that they have tried to smoke , and one in four 15-year olds answer that they smoke regularly .
BACKGROUND	Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries .
BACKGROUND	Previous school-based programs to prevent smoking have shown contrasting results internationally .
BACKGROUND	In Denmark , previous programs have shown limited or no effect .
BACKGROUND	This indicates a need for developing a well-designed , comprehensive , and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X : IT , a study including 1 ) the development of a 3-year school-based multi-component intervention and 2 ) the randomized trial investigating the effect of the intervention .
BACKGROUND	The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25 % .
METHODS	The X : IT study is based on the Theory of Triadic Influences .
METHODS	The theory organizes factors influencing adolescent smoking into three streams : cultural environment , social situation , and personal factors .
METHODS	We added a fourth stream , the community aspects .
METHODS	The X : IT program comprises three main components : 1 ) smoke-free school premises , 2 ) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents , and 3 ) a curricular component .
METHODS	The study encompasses process - and effect-evaluations as well as health economic analyses .
METHODS	Ninety-four schools in 17 municipalities were randomly allocated to the intervention ( 51 schools ) or control ( 43 schools ) group .
METHODS	At baseline in September 2010 , 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire ( response rate = 93.3 % ) .
CONCLUSIONS	The X : IT study is a large , randomized controlled trial evaluating the effect of an intervention , based on components proven to be efficient in other Nordic settings .
CONCLUSIONS	The X : IT study directs students , their parents , and smoking prevention policies at the schools .
CONCLUSIONS	These elements have proven to be effective tools in preventing smoking among adolescents .
CONCLUSIONS	Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation .
CONCLUSIONS	X : IT creates the basis for thorough effect and process evaluation , focusing on various social groups .
BACKGROUND	Current Controlled Trials ISRCTN77415416 .

###7974297
BACKGROUND	Nedocromil sodium , a nonsteroidal anti-inflammatory drug , is effective in the treatment of asthma .
BACKGROUND	Its efficacy in the treatment of chronic obstructive pulmonary disease ( COPD ) has not been investigated .
METHODS	Fifty four non-allergic patients with COPD were randomised to 10 weeks of treatment with placebo or nedocromil sodium ( 4 x 8 mg/day ) in a double blind study .
RESULTS	Nedocromil sodium treatment had no effect on airway responsiveness to histamine , methacholine , and adenosine-5 ' - monophosphate , pulmonary function , and symptom scores .
RESULTS	Both patients and clinicians favoured treatment with nedocromil sodium , however , and the number of dropouts ( because of exacerbations ) was fewer during treatment with the drug .
CONCLUSIONS	Longer trials will be necessary to assess if nedocromil sodium can reduce the frequency of exacerbations and the decrease in pulmonary function , eventually leading to a better quality of life in patients with COPD .

###16616620
OBJECTIVE	This paper describes the methodology of a clinical trial of prone positioning in pediatric patients with acute lung injury ( ALI ) .
OBJECTIVE	Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/acute respiratory distress syndrome without the risk of serious iatrogenic injury .
OBJECTIVE	It is not known if these improvements in oxygenation result in improvements in clinical outcomes .
OBJECTIVE	A clinical trial was needed to answer this question .
METHODS	The pediatric prone study is a multicenter , randomized , noncrossover , controlled clinical trial .
METHODS	The trial is designed to test the hypothesis that at the end of 28 days , children with ALI treated with prone positioning will have more ventilator-free days than children treated with supine positioning .
METHODS	Secondary end points include the time to recovery of lung injury , organ failure-free days , functional outcome , adverse events , and mortality from all causes .
METHODS	Pediatric patients , 42 weeks postconceptual age to 18 years of age , are enrolled within 48 hours of meeting ALI criteria .
METHODS	Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days .
METHODS	Both groups are managed according to ventilator protocol , extubation readiness testing , and sedation protocols and hemodynamic , nutrition , and skin care guidelines .
CONCLUSIONS	This paper describes the process , multidisciplinary input , and procedures used to support the design of the clinical trial , as well as the challenges faced by the clinical scientists during the conduct of the clinical trial .

###25253539
BACKGROUND	Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation .
BACKGROUND	To date , very few findings are available for primary care patients , and especially for the involvement of general practitioners .
OBJECTIVE	Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting .
METHODS	The study was an unblinded cluster-randomized trial with an observation period of 12 weeks .
METHODS	Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education , motivation , exercise guidance , daily short message service ( SMS ) reminding , weekly feedback through Internet , and active monitoring by general practitioners .
METHODS	All components of the program are fully automated .
METHODS	Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program .
METHODS	The main outcome was the biochemically confirmed smoking status after 12 weeks .
RESULTS	We recruited 168 participants ( 86 intervention group , 82 control group ) into the study .
RESULTS	For 51 participants from the intervention group and 70 participants from the control group , follow-up data were available both at baseline and 12 weeks .
RESULTS	Very few patients ( 9.8 % , 5/51 ) from the intervention group and from the control group ( 8.6 % , 6/70 ) successfully managed smoking cessation ( OR 0.86 , 95 % CI 0.25-3 .0 ; P = .816 ) .
RESULTS	Similar results were found within the intent-to-treat analysis : 5.8 % ( 5/86 ) of the intervention group and 7.3 % ( 6/82 ) of the control group ( OR 1.28 , 95 % CI 0.38-4 .36 ; P = .694 ) .
RESULTS	The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group ( 2.7 mean difference ; 95 % CI -5.33 to -0.58 ; P = .045 ) .
RESULTS	After adjustment for the baseline value , age , gender , and height , this significance decreases ( mean difference 2.2 ; 95 % CI -4.7 to 0.3 ; P = .080 ) .
CONCLUSIONS	This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care .
CONCLUSIONS	The limited statistical power and the high drop-out rate may have reduced the study 's ability to detect significant differences between the groups .
CONCLUSIONS	Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome .
BACKGROUND	German Register for Clinical Trials , registration number DRKS00003067 ; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID = DRKS00003067 ( Archived by WebCite at http://www.webcitation.org/6Sff1YZpx ) .

###10902624
BACKGROUND	Infection with Streptococcus pneumoniae is a frequent and serious problem for HIV-immunosuppressed adults .
BACKGROUND	Vaccination is recommended in the USA and Europe , but there are no prospective data that show vaccine efficacy .
METHODS	1392 ( 937 female ) HIV-1-infected adults in Entebbe , Uganda , were enrolled .
METHODS	697 received 23-valent pneumococcal polysaccharide vaccine and 695 received placebo .
METHODS	The primary endpoint was first event invasive pneumococcal disease .
METHODS	Secondary endpoints included vaccine serogroup-specific invasive disease , all ( probable and definite ) pneumococcal events , all-cause pneumonia , and death .
RESULTS	First invasive events occurred in 25 individuals ( 24 bacteraemias , one pyomyositis ) , 15 in the vaccine arm and ten in the placebo arm ( hazard ratio [ HR ] 1.47 ; 95 % CI 0.7-3 .3 ) .
RESULTS	22 isolates ( 88 % ) were of vaccine-specific serogroups with 15 events in the vaccine arm compared with seven in the placebo arm ( HR 2.10 ; 0.9-5 .2 ) .
RESULTS	All pneumococcal events had a similar distribution ( 20 vs 14 ; HR 1.41 ; 0.7-2 .8 ) though all-cause pneumonia was significantly more frequent in the vaccine arm ( 40 vs 21 ; HR 1.89 ; 1.1-3 .2 ) .
RESULTS	Mortality was unaffected by vaccination .
CONCLUSIONS	23-valent pneumococcal polysaccharide vaccination is ineffective in HIV-1-infected Ugandan adults and probably has little , or no , public health value elsewhere in sub-Saharan Africa .
CONCLUSIONS	Increased rates of pneumococcal disease in vaccine recipients may necessitate a reappraisal of this intervention in other settings .

###11984291
OBJECTIVE	Differences in gross mechanical efficiency between experienced and inexperienced wheelchair users may be brought about by differences in propulsion technique .
OBJECTIVE	The purpose of this experiment was to study changes in propulsion technique ( defined by force application , left-right symmetry , intercycle variability , and timing ) and gross mechanical efficiency during a 3-wk wheelchair practice period in a group of novice able-bodied nonwheelchair users .
METHODS	Subjects were randomly divided over an experimental group ( N = 10 ) and a control group ( N = 10 ) .
METHODS	The experimental group received a 3-wk wheelchair practice period ( 3.wk-1 , i.e. , 9 practice trials ) on a computer-controlled wheelchair ergometer , whereas the control group only participated in trials 1 and 9 .
METHODS	During all nine practice trials , propulsion technique variables and mechanical efficiency were measured .
RESULTS	No significant differences between the groups were found for force application , left-right symmetry , and intercycle variability .
RESULTS	The push frequency and negative power deflection at the start of the push phase diminished significantly in the experimental group in contrast to the control group ( P < 0.05 ) .
RESULTS	Work per cycle , push time , cycle time , and mechanical efficiency increased .
CONCLUSIONS	The practice period had a favorable effect on some technique variables and mechanical efficiency , which may indicate a positive effect of improved technique on mechanical efficiency .
CONCLUSIONS	Although muscle activation and kinematic segment characteristics were not measured in the present study , they may also impact mechanical efficiency .
CONCLUSIONS	No changes occurred over time in most force application parameters , left-right symmetry , and intercycle variability during the 3-wk practice period ; however , these variables may change on another time scale .

###8008541
OBJECTIVE	This study was conducted to determine whether a specialized form of nursing could help prevent or reduce psychosocial maladjustment among children , aged 4 to 16 years , with chronic physical disorders .
OBJECTIVE	In contrast to other studies , nurses were chosen to provide the intervention based on their central role in health care and the appropriateness of their training for this task .
METHODS	A clinical trial was conducted in which 332 children and their families were randomly assigned either to receive this specialized nursing for a 1-year period , or to remain in the control condition .
METHODS	The children were all active outpatients in nine clinics at the Montreal Children 's Hospital .
METHODS	Three measures of psychosocial functioning administered before and after the intervention were the basis for assessing its efficacy .
METHODS	The measures included the behavior problems profile of the Achenbach Child Behavior Checklist , the Personal Adjustment and Role Skills , completed by the parents , and two versions of the Self-Perception Profile ( Harter ) for children aged 4 to 7 years and 8 to 16 years .
RESULTS	Differences between groups were examined both categorically and quantitatively .
RESULTS	In the former , the percent of children with clinical scores ( those above or below a cut-off indicative of maladjustment ) at baseline and postintervention were compared .
RESULTS	In the latter , the mean scores at the end of the trial were analyzed using analysis of covariance with the baseline scores as covariates .
RESULTS	Statistically significant positive differences were found in the domain of anxiety/depression on the Personal Adjustment and Role Skills , and in the areas of scholastic competence , behavior , and global self-worth on the Harter .
CONCLUSIONS	The results indicate that this intervention helps children with chronic disorders by preventing or reducing maladjustment .
CONCLUSIONS	Most university-prepared nurses already have the basic skills required to achieve these results ; only a modest investment in reorientation may be needed .
CONCLUSIONS	Thus , other pediatric centers should be able to replicate these findings and thereby take a major step toward improving the lives of children with chronic disorders .

###15288885
BACKGROUND	A double-blind randomized controlled trial was carried out to assess the effect of sour milk , containing two tripeptides ( valine-proline-proline and isoleucine-proline-proline ) , on blood pressure ( BP ) .
METHODS	A total of 46 borderline hypertensive men aged 23 to 59 years were recruited at their workplace for this trial .
METHODS	Subjects were randomly allocated into two groups ; sour milk drink group ( S-group , n = 23 ) and placebo ( acidified milk ) drink group ( P-group , n = 23 ) for 4 weeks .
METHODS	Blood pressure was measured twice at each occasion by a physician , at the health center of the company , with a mercury at baseline , 2 and 4 weeks .
METHODS	Statistical analysis was performed by SPSS 10.0 J.
RESULTS	The S-group and P-group showed no significant difference in baseline systolic BP ( mean [ SD ] , S : 147.6 [ 9.6 ] , P : 145.3 [ 13.0 ] ) or diastolic BP ( S : 95.3 [ 9.9 ] , P : 91.5 [ 9.6 ] ) .
RESULTS	In the S-group , change in systolic BP at 2 and 4 weeks were -4.3 mm Hg ( 95 % confidence interval [ CI ] -8.3 to -0.4 ; P = .032 ) and -5.2 mm Hg ( 95 % CI -10.1 to -0.3 ; P = .039 ) , both statistically significant .
RESULTS	Diastolic BP showed change from -1.7 mm Hg ( 95 % CI -5.4 to 2.0 ) at 2 weeks and -2.0 ( 95 % CI -5.4 to 1.5 ) at 4 weeks , respectively .
RESULTS	In the P-group , change in systolic BP were -0.5 ( 95 % CI -5.8 to 4.8 ) at 2 weeks and -3.7 ( 95 % CI -8.3 to 0.9 ) and change in diastolic BP were -0.6 ( 95 % CI -4.7 to 3.6 ) and -0.3 ( 95 % CI -3.9 to 3.3 ) , which were not statistically significant .
CONCLUSIONS	This trial demonstrated the beneficial effect of sour milk on BP in borderline hypertensive men who were not taking antihypertensive medication .

###20164315
BACKGROUND	Despite decades of research on the relation between soy and breast cancer , questions regarding the absorption , metabolism , and distribution of isoflavones in breast tissue largely remain unanswered .
OBJECTIVE	We evaluated the potential health effects of isoflavone consumption on normal breast tissue ; isoflavone concentrations , metabolites , and biodistribution were investigated and compared with 17beta-estradiol exposure .
METHODS	In this dietary intervention study , healthy women were randomly allocated to a soy milk ( n = 11 ; 16.98-mg genistein and 5.40-mg daidzein aglycone equivalents per dose ) , soy supplement ( n = 10 ; 5.27-mg genistein and 17.56-mg daidzein aglycone equivalents per dose ) , or control ( n = 10 ) group .
METHODS	After a run-in period > or = 4 d , 3 doses of soy milk or soy supplements were taken daily for 5 d before an esthetic breast reduction .
METHODS	Blood and breast biopsies were collected during surgery and analyzed with liquid chromatography-tandem mass spectrometry .
RESULTS	After soy administration , genistein and total daidzein concentrations , which were expressed as aglycone equivalents , ranged from 135.1 to 2831 nmol/L and 105.1 to 1397 nmol/L , respectively , in hydrolyzed serum and from 92.33 to 493.8 pmol/g and 22.15 to 770.8 pmol/g , respectively , in hydrolyzed breast tissue .
RESULTS	The major metabolites identified in nonhydrolyzed samples were genistein-7-O-glucuronide and daidzein-7-O-glucuronide , with an overall glucuronidation of 98 % .
RESULTS	Total isoflavones showed a breast adipose/glandular tissue distribution of 40:60 , and their mean ( + / - SEM ) derived 17beta-estradiol equivalents toward estrogen receptor beta were 21 + / - 4-fold and 40 + / - 10-fold higher than the 17beta-estradiol concentrations in adipose ( 0.283 + / - 0.089 pmol/g , P < 0.001 ) and glandular ( 0.246 + / - 0.091 pmol/g , P = 0.001 ) fractions , respectively .
CONCLUSIONS	After intake of soy milk and soy supplements , isoflavones reach exposure levels in breast tissue at which potential health effects may occur .

###23265088
BACKGROUND	Smoking is the leading cause of preventable death in the US , while abstinence rates remain modest .
BACKGROUND	Smoking has been shown to be perpetuated by operant conditioning , notably negative reinforcement ( e.g. , smoking to relieve negative affective states ) .
BACKGROUND	Mindfulness training ( MT ) shows promise for smoking cessation , by potentially altering an individual 's tendency to smoke in response to craving .
BACKGROUND	The purpose of this study was to examine the effects of MT and mindfulness practice on the relationship between smoking and craving after receiving four weeks of MT.
METHODS	33 adults received MT as part of a randomized trial for smoking cessation .
METHODS	Individuals in the MT condition recorded formal and informal mindfulness practice during treatment using daily diaries .
RESULTS	Analyses showed that strong correlations between craving and smoking at baseline ( r = 0.582 ) were attenuated at the end of treatment ( r = 0.126 ) .
RESULTS	Mindfulness home practice significantly predicted cigarette use ( formal : B = -1.21 , p = 0.007 ; informal : B = -1.52 , p < 0.0001 ) and informal practice moderated the relationship between craving and smoking at the end of treatment ( B = 0.52 , p = 0.03 ) .
CONCLUSIONS	These findings suggest that MT may be effective as a treatment for smoking cessation and that informal mindfulness practice predicts a decoupling of the association between craving and smoking .

###24474305
BACKGROUND	Smoking prevalence is 49 % among Medicaid enrollees in Ohio .
BACKGROUND	The objective of this pilot project was to test a comprehensive tobacco dependence treatment program targeting rural Medicaid-enrolled smokers for both physician-level and smoker-level outcomes .
METHODS	Using a group-randomized trial design , intervention group physicians ( n = 4 ) were exposed to systems-level changes in their clinics , and smokers in these clinics were offered 12 weeks of telephone cessation counseling .
METHODS	Control group physicians ( n = 4 ) were given the clinician 's version of the U.S. Public Health Serivce ( USPHS ) Clinical Practice Guideline , and smokers in these clinics were given information about the Ohio Tobacco Quitline .
METHODS	Physician-level and smoker-level outcomes were assessed at 1 week and 3 months , respectively .
METHODS	Costs per quit were estimated .
RESULTS	A total of 214 Medicaid smokers were enrolled .
RESULTS	At 1 week , there were no reported differences in rates of being asked about tobacco use ( 68 % intervention , 58 % control ) or advised to quit ( 69 % intervention , 63 % control ) .
RESULTS	However , 30 % of intervention and 56 % of control smokers reported receiving a prescription for pharmacotherapy ( p < .01 ) .
RESULTS	At 3 months , there were no differences in quit attempts ( 58 % intervention , 64 % control ) , use of pharmacotherapy ( 34 % intervention , 46 % control ) , or abstinence ( 24 % intervention , 16 % control for self-reported abstinence ; 11 % intervention , 3.5 % control for cotinine-confirmed abstinence ) .
RESULTS	The intervention group proved more cost-effective at achieving confirmed quits ( $ 6,800 vs. $ 9,700 ) .
CONCLUSIONS	We found few differences in outcomes between physicians exposed to a brief intervention and physicians who were intensively trained .
CONCLUSIONS	Future studies should examine how tobacco dependence treatment can be further expanded in Medicaid programs .

###12520569
BACKGROUND	The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function .
BACKGROUND	Perioperative steroid administration has been advocated to reduce liver damage .
BACKGROUND	The aim of this prospective , randomized study was to determine whether steroid administration can reduce liver injury and improve short-term outcome .
METHODS	Fifty-three patients undergoing liver resection were randomized to a steroid group ( group 1 ) or to a control group ( group 2 ) ; patients in group 1 received methylprednisolone 30 mg/kg 30 min before liver resection whereas those in group 2 did not .
METHODS	Serum levels of interleukin ( IL ) 6 , total bilirubin , aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) , and prothrombin time ( PT ) were measured .
METHODS	Length of stay , and type and number of complications were recorded .
RESULTS	Serum IL-6 levels were significantly lower in the steroid group than in the control group 24 h after surgery .
RESULTS	Steroid administration significantly modified AST , ALT and PT levels only in patients with chronic liver disease .
RESULTS	Overall and lung-related morbidity were not significantly different between the two groups .
CONCLUSIONS	Steroid administration suppresses serum IL-6 levels , but has no effect on short-term outcome .

###22925046
OBJECTIVE	Like many indigenous peoples , New Zealand Mori bear a heavy burden of alcohol-related harm relative to their non-indigenous compatriots , and disparities are greatest among young adults .
OBJECTIVE	We tested the effectiveness of web-based alcohol screening and brief intervention ( e-SBI ) for reducing hazardous drinking among Mori university students .
METHODS	Parallel , double-blind , multi-site , randomized controlled trial .
METHODS	Seven of New Zealand 's eight universities .
METHODS	In April 2010 , we sent e-mail invitations to all 6697 17-24-year-old Mori students to complete a brief web questionnaire including the Alcohol Use Disorders Identification Test ( AUDIT ) - C , a screening tool for hazardous and harmful drinking .
METHODS	Those screening positive were computer randomized to : < 10 minutes of web-based alcohol assessment and personalized feedback ( intervention ) or screening alone ( control ) .
METHODS	We conducted a fully automated 5-month follow-up assessment with observers and participants blinded to study hypotheses , design and intervention delivery .
METHODS	Pre-determined primary outcomes were : ( i ) frequency of drinking , ( ii ) amount consumed per typical drinking occasion , ( iii ) overall volume of alcohol consumed and ( iv ) academic problems .
RESULTS	Of the participants , 1789 were hazardous or harmful drinkers ( AUDIT-C4 ) and were randomized : 850 to control , 939 to intervention .
RESULTS	Follow-up assessments were completed by 682 controls ( 80 % ) and 733 intervention group members ( 78 % ) .
RESULTS	Relative to controls , participants receiving intervention drank less often [ RR = 0.89 ; 95 % confidence interval ( CI ) : 0.82-0 .97 ] , less per drinking occasion ( RR = 0.92 ; 95 % CI : 0.84-1 .00 ) , less overall ( RR = 0.78 ; 95 % CI : 0.69-0 .89 ) and had fewer academic problems ( RR = 0.81 ; 95 % CI : 0.69-0 .95 ) .
CONCLUSIONS	Web-based screening and brief intervention reduced hazardous and harmful drinking among non-help-seeking Mori students in a large-scale pragmatic trial .
CONCLUSIONS	The study has wider implications for behavioural intervention in the important but neglected area of indigenous health .

###21332248
BACKGROUND	The most specific indicator of a drug-induced liver injury signal in a clinical trial database is believed to be the occurrence of subjects experiencing drug-associated elevations in both serum ALT and serum total bilirubin ( TB ) without a significant elevation in serum alkaline phosphatase ( ALP ) .
BACKGROUND	eDISH ( evaluation of Drug-Induced Serious Hepatotoxicity ) is a recently described tool that organizes liver laboratory data by graphically displaying peak serum ALT and TB levels for each subject , and can also provide direct links to the pertinent clinical and laboratory data for each subject .
OBJECTIVE	To illustrate the usefulness of the eDISH approach in the presentation of liver safety data by using phase III clinical trial data for rivaroxaban .
METHODS	Four randomized , active-controlled studies were conducted worldwide in subjects undergoing elective hip or knee replacement surgery to compare the efficacy and safety of the anticoagulant rivaroxaban , an oral , direct Factor Xa inhibitor , with the low-molecular-weight heparin , enoxaparin .
METHODS	Liver laboratory assessments , including ALT , AST , TB and ALP , were performed frequently during the studies .
METHODS	Data were incorporated into eDISH and linked data for selected subjects were analysed .
RESULTS	In the pooled analysis of the four studies , a total of 12262 subjects ( 6131 rivaroxaban , 6131 enoxaparin ) received at least one dose of study drug and had at least one central and/or local laboratory assessment during the study .
RESULTS	A total of 143 ( 2.33 % ) rivaroxaban subjects and 223 ( 3.64 % ) enoxaparin subjects experienced a peak ALT > 3upper limit of normal ( ULN ) but did not experience an elevation of TB > 2ULN ; these subjects are displayed in the right lower quadrant of the eDISH plot , termed the ` Temple 's Corollary quadrant ' .
RESULTS	There were ten rivaroxaban and ten enoxaparin subjects with a peak ALT > 3ULN and a peak TB > 2ULN ; these subjects were displayed in the right upper quadrant of the eDISH plot , termed the ` Hy 's Law quadrant ' .
RESULTS	eDISH allowed efficient examination of the relevant data for each of these subjects .
CONCLUSIONS	The eDISH approach is an efficient and effective way to organize and examine large liver safety databases for randomized controlled clinical trials .
CONCLUSIONS	It greatly facilitates a systematic and transparent examination of the relevant liver safety laboratory data .
CONCLUSIONS	We believe eDISH should become a standard approach for assessing and studying liver safety issues in clinical trials .

###12019407
BACKGROUND	Enteral fluconazole , a triazole antifungal agent with an excellent oral bioavailability , has not been widely studied in critically ill surgical patients .
METHODS	During a randomized placebo-controlled trial of enteral fluconazole ( N = 130 ) versus placebo ( N = 130 ) for the prevention of fungal infections in critically ill surgical patients , trough fluconazole levels were measured after the loading dose and 3 times weekly during intensive care unit stay .
METHODS	Minimum inhibitory concentrations ( MICs ) for fluconazole were measured on all infecting Candida isolates .
RESULTS	Four hundred sixty-seven serum samples were assayed for fluconazole levels in 121 patients .
RESULTS	The most common infecting fungal species was Candida albicans , isolated in 14 of 31 infections ( 45 % ) .
RESULTS	Other infecting species were C glabrata , C tropicalis , and C parapsilosis .
RESULTS	Mean fluconazole levels were above the highest MIC for C albicans and C parapsilosis in all but 5 patients ( 4 % ) .
RESULTS	Mean fluconazole levels were below the median MIC for C glabrata in 93 of 121 patients ( 77 % ) .
RESULTS	No significant relationship was seen between fluconazole levels and risk for fungal infection .
CONCLUSIONS	Serum fluconazole levels are above the MIC of most yeast species found in these patients .
CONCLUSIONS	These levels may not be above the MIC of C glabrata , the second most common Candida isolate causing infection in this study .

###11753054
OBJECTIVE	To evaluate the efficacy of acute normovolemic hemodilution ( ANH ) and intraoperative cell salvage ( ICS ) in blood-conservation strategies for infrarenal aortic surgery .
BACKGROUND	Recent concerns over the risks of transfusion-related infection have resulted in sharp rises in the cost of blood preparations .
BACKGROUND	Autologous transfusion may be a safe alternative to allogeneic transfusion , which has been associated with immune modulation and postoperative infection .
METHODS	This multicenter prospective randomized trial compared standard transfusion practice with autologous transfusion combining ANH with ICS in 145 patients undergoing elective aortic surgery .
METHODS	The primary outcome measures were the proportion of patients requiring allogeneic blood and the volume of allogeneic transfusion .
METHODS	The secondary outcome measures were the frequency of complications , including postoperative infection , and postoperative hospital stay .
RESULTS	The combination of ANH and ICS reduced the volume of allogeneic blood transfused from a median of two units to zero units .
RESULTS	The proportion of patients transfused was 56 % in allogeneic and 43 % in autologous .
RESULTS	There were no significant differences in complications or length of hospital stay .
CONCLUSIONS	Both ANH and ICS were safe and reduced the allogeneic blood requirement in patients undergoing elective infrarenal aortic surgery .

###19909421
BACKGROUND	Obesity and mental health disorders are 2 major public health problems in American adolescents , with prevalence even higher in Hispanic teens .
BACKGROUND	Despite the rapidly increasing incidence and adverse health outcomes associated with overweight and mental health problems , very few intervention studies have been conducted with adolescents to improve both their healthy lifestyles and mental health outcomes .
BACKGROUND	Even fewer studies have been conducted with Hispanic youth .
BACKGROUND	The purpose of this study was to evaluate the preliminary efficacy of the COPE ( Creating Opportunities for Personal Empowerment ) Healthy Lifestyles TEEN ( Thinking , Emotions , Exercise , and Nutrition ) program , a manualized educational and cognitive behavioral skills-building program , on Hispanic adolescents ' healthy lifestyle choices as well as mental and physical health outcomes .
METHODS	A cluster randomized controlled pilot study was conducted with 19 Hispanic adolescents enrolled in 2 health classes in a southwestern high school .
METHODS	One class received COPE and the other received an attention control program .
RESULTS	Adolescents in the COPE program increased their healthy lifestyle choices and reported a decrease in depressive and anxiety symptoms from baseline to postintervention follow-up .
RESULTS	A subset of 7 overweight adolescents in the COPE program had a decrease in triglycerides and an increase in high-density lipoproteins .
RESULTS	In addition , these overweight adolescents reported increases in healthy lifestyle beliefs and nutrition knowledge along with a decrease in depressive symptoms .
CONCLUSIONS	The COPE TEEN program is a promising school-based strategy for improving both physical and mental health outcomes in adolescents .

###21899544
OBJECTIVE	This study was conducted to assess the effects of chronic daily methylsulfonylmethane ( MSM ) supplementation on known markers of oxidative stress following acute bouts of exercise in untrained healthy young men .
METHODS	Eighteen untrained men volunteered for this study .
METHODS	Participants were randomized in a double-blind placebo-controlled fashion into two groups : MSM ( n = 9 ) and placebo ( n = 9 ) .
METHODS	The participants took supplementation or placebo daily for 10 days before running .
METHODS	Participants ran 14 km .
METHODS	The MSM supplementation was prepared in water at 50 mg/kg body weight .
METHODS	The placebo group received water .
METHODS	Serum malondialdehyde ( MDA ) , protein carbonyl ( PC ) and plasma oxidized glutathione ( GSSG ) were measured as markers of oxidative stress .
METHODS	The plasma-reduced glutathione ( GSH ) level and the GSH/GSSG ratio were determined as markers of plasma antioxidant capacity .
RESULTS	Acute exercise led to elevated levels of serum MDA , PC and plasma GSSG .
RESULTS	MSM supplementation maintained PC , MDA and GSSG at lower levels after exercise than the placebo .
RESULTS	The plasma level of GSH and the ratio of GSH/GSSG were significantly higher in the MSM supplemented group .
CONCLUSIONS	These results suggest that chronic daily oral supplementation of MSM has alleviating effects on known markers of oxidative stress following acute bouts of exercise in healthy young men .

###24902407
OBJECTIVE	To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush .
METHODS	This study used a randomized , examiner-blind , single-center , two-treatment , parallel group 4-week design .
METHODS	Subjects with pre-existing plaque scores of at least 1.75 on the Turesky Modification of the Quigley-Hein Plaque Index ( TMQHPI ) were evaluated for baseline whole mouth and approximal plaque scores .
METHODS	They received either the oscillating-rotating brush ( Oral-B Professional Care 1000 , sold as Oral-B Professional Care 600 in some regions , with the Oral-B Precision Clean brush head , D16u/EB20 ) or the sonic brush ( Colgate ProClinical C200 with Colgate Triple Clean brush head ) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for 4 weeks before returning for plaque measurements .
METHODS	Prior to baseline and the Week 4 measurements , participants abstained from oral hygiene for 12 hours and from eating , chewing gum and drinking for 4 hours .
RESULTS	A total of 131 subjects were enrolled in the study at baseline , with all completing the study : 65 in the oscillating-rotating group , and 66 in the sonic group .
RESULTS	Both brushes significantly reduced plaque over the 4-week study period .
RESULTS	The oscillating-rotating brush was statistically significantly more effective in reducing plaque ( P < 0.001 ) than the sonic brush .
RESULTS	Compared to the sonic power brush , the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas .

###26126062
BACKGROUND	Type 2 diabetes mellitus is a chronic condition that requires ongoing , life-long care in order to be controlled .
OBJECTIVE	The aims of the study were to assess the effect of nursing case management on glycated hemoglobin ( HbA1c ) levels compared to usual care in people with type 2 diabetes mellitus and to determine if effects of nursing case management varied by gender , age , duration of disease , education , and income .
METHODS	This is a pragmatic clinical trial , conducted in the municipality of Bandeirantes , Paran , Brazil , in 2011 and 2012 .
METHODS	Eighty individuals were recruited and randomized equally to receive nursing case management or usual care .
METHODS	Covariates were sociodemographic and clinical factors .
METHODS	The outcome was HbA1c measured at baseline , 6 months , and 12 months .
RESULTS	The sample consisted predominately of women ; most had been diagnosed with type 2 diabetes mellitus within the previous 5 years .
RESULTS	Mean age was 50.14 ( SD = 7.00 ) , with 5.27 ( SD = 4.39 ) years of schooling and an average HbA1c of 9.90 % ( SD = 2.49 ) .
RESULTS	Hemoglobin A1c was reduced from an average of 10.33 % to 9.0 % ( p < .01 ) in the nursing case management group and from 9.57 % to 8.93 % ( p = .05 ) in the usual care group ; the group by time effect was not significant .
RESULTS	Case management effects varied by younger age ( p = .05 ) , duration of type 2 diabetes less than 5 years ( p = .03 ) , up to 4 years of schooling ( p = .04 ) , and being in the lowest-income stratum ( p = .02 ) .
CONCLUSIONS	Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline .
CONCLUSIONS	The difference in proportional reduction of HbA1c between groups was not statistically significant .

###21147783
BACKGROUND	The aim of this study was to compare intubating conditions and adverse events after sevoflurane induction in infants , with or without the use of rocuronium or alfentanil .
METHODS	Seventy-five infants , aged 1-24 months , undergoing elective surgery under general anaesthesia were randomly assigned to receive 8 % sevoflurane with either placebo ( i.v. saline 0.5 ml kg ) , rocuronium ( 0.3 mg kg ) , or alfentanil ( 20 g kg ) .
METHODS	The primary outcome measure was intubating conditions evaluated 90 s after test drug injection by an anaesthetist unaware of the patient 's group .
METHODS	The secondary outcome criteria were respiratory ( Sp ( O ) < 90 % , laryngospasm , closed vocal cords preventing intubation , bronchospasm ) and haemodynamic adverse events ( heart rate and mean arterial pressure variations 30 % control value ) .
RESULTS	Intubating conditions were significantly better in the rocuronium group , with clinically acceptable intubating conditions in 92 % , vs 70 % in the alfentanil group and 63 % in the placebo group ( P = 0.044 ) .
RESULTS	Adverse respiratory events were significantly less frequent in the rocuronium group : 0 % vs 33 % in the placebo group and 30 % in the alfentanil group ( P = 0.006 ) .
RESULTS	Haemodynamic adverse events were more frequent in the alfentanil group : 48 % vs 7 % in the placebo group and 16 % in the rocuronium group ( P = 0.0019 ) .
CONCLUSIONS	In 1 - to 24-month-old infants , the addition of 0.3 mg kg rocuronium to 8 % sevoflurane improved intubating conditions and decreased the frequency of respiratory adverse events .
CONCLUSIONS	Alfentanil provided no additional benefit in this study .

###24289597
OBJECTIVE	To compare the effectiveness of different methods of recall for repeat Pap smear among women who had normal smears in the previous screening .
METHODS	Prospective randomized controlled study .
METHODS	All community clinics in Klang under the Ministry of Health Malaysia .
METHODS	Women of Klang who attended cervical screening and had a normal Pap smear in the previous year , and were due for a repeat smear were recruited and randomly assigned to four different methods of recall for repeat smear .
METHODS	The recall methods given to the women to remind them for a repeat smear were either by postal letter , registered letter , short message by phone ( SMS ) or phone call .
METHODS	Number and percentage of women who responded to the recall within 8 weeks after they had received the recall , irrespective whether they had Pap test conducted .
METHODS	Also the numbers of women in each recall method that came for repeat Pap smear .
RESULTS	The rates of recall messages reaching the women when using letter , registered letter , SMS and phone calls were 79 % , 87 % , 66 % and 68 % , respectively .
RESULTS	However , the positive responses to recall by letter , registered letter , phone messages and telephone call were 23.9 % , 23.0 % , 32.9 % and 50.9 % , respectively ( p < 0.05 ) .
RESULTS	Furthermore , more women who received recall by phone call had been screened ( p < 0.05 ) compared to those who received recall by postal letter ( OR = 2.38 , CI = 1.56-3 .62 ) .
CONCLUSIONS	Both the usual way of sending letters and registered letters had higher chances of reaching patients compared to using phone either for sending messages or calling .
CONCLUSIONS	The response to the recall method and uptake of repeat smear , however , were highest via phone call , indicating the importance of direct communication .

###20057309
OBJECTIVE	To assess the effects of decreased antiretroviral therapy exposure on body fat and metabolic parameters .
METHODS	Substudy of the Strategies for Management of Anti-Retroviral Therapy study , in which participants were randomized to intermittent CD4-guided [ Drug Conservation ( DC ) group ] or to continuous [ Viral Suppression ( VS ) group ] antiretroviral therapy .
METHODS	Participants at 33 sites were coenrolled in the Strategies for Management of Anti-Retroviral Therapy Body Composition substudy .
METHODS	Regional fat was assessed annually by whole-body dual-energy X-ray absorptiometry and abdominal computed tomography .
METHODS	Fasting metabolic parameters were assessed at months 4 , 8 , and annually .
METHODS	Treatment groups were compared for changes in fat and metabolic markers using longitudinal mixed models .
RESULTS	Two hundred and seventy-five patients were randomized to the DC ( n = 142 ) or VS ( n = 133 ) group and followed for a median of 2.0 years .
RESULTS	By month 12 , limb fat ( DC-VS difference 9.8 % , 95 % confidence interval 3.5-16 .1 ; P = 0.003 ) and subcutaneous abdominal fat ( DC-VS difference 14.3 cm , 95 % confidence interval -0.1 to 28.7 ; P = 0.05 ) increased in the DC group .
RESULTS	There was no treatment difference in visceral abdominal fat ( DC-VS difference -2.1 % , 95 % confidence interval -13.5 to 9.4 ; P = 0.72 ) .
RESULTS	Lipids significantly decreased in the DC group by month 4 and treatment differences persisted throughout follow-up ( P < or = 0.001 ) .
RESULTS	By 12 months , hemoglobin A1C increased in the DC ( +0.3 % ) and remained stable in the VS group ( P = 0.003 ) ; the treatment difference remained significant throughout follow-up ( P = 0.02 ) .
CONCLUSIONS	After 12 months , intermittent antiretroviral therapy increased subcutaneous fat , had no effect on visceral abdominal fat , decreased plasma lipids , and increased hemoglobin A1C compared with continuous antiretroviral therapy .

###23648392
BACKGROUND	Nutrition is a key element in geriatric health .
BACKGROUND	Protein-energy malnutrition is common in institutionalized persons .
OBJECTIVE	This study examined the effectiveness of a need-based `` routine screening and timely intervention '' strategy in improving the nutritional status of persons living in nursing homes .
METHODS	A 24-week randomized , double-blind , controlled trial .
METHODS	A privately managed geriatric nursing home in Taiwan .
METHODS	Ninety-two 65-year old persons who were 25kg/m ( 2 ) , > 1 month residence , able to self-feed or receive oral feeding , without acute infection and non-bed-ridden .
METHODS	Prospective participants were stratified by gender and then randomly assigned to either the control group ( n = 45 ) or the intervention group ( n = 47 ) .
METHODS	Each subject in the intervention group was given a 50g/day soy-protein-based nutritional supplement if he/she was rated as undernourished according to the Mini Nutritional Assessment ( MNA , score 24 ) and BMI 24kg/m ( 2 ) .
METHODS	The supplement contained 9.5 g protein , 250kcal energy and all essential micro-nutrients .
METHODS	The supplementation would be suspended once either one of the `` at risk '' condition was corrected .
METHODS	Nutritional rating with the MNA took place at baseline and every 4 weeks during the trial .
METHODS	Biochemical indicators were measured at baseline , mid-point ( week-12 ) and end-point ( week-24 ) .
METHODS	Results were analyzed with the two-sample t-test , and the generalized estimating equations ( GEE ) controlled for demographic and health-related variables .
RESULTS	Of the 92 subjects , 82 completed the trial ; 7 withdrew and 3 died during the trial .
RESULTS	Results showed that the need-based intervention was an effective and appropriate strategy for improving the nutritional status of persons at risk of undernourishment .
RESULTS	The intervention significantly improved body weight , BMI , mid-arm circumference , calf circumference , and serum albumin and cholesterol concentrations at all intervals ( all p < 0.05 ) .
RESULTS	However , the intervention did not significantly improve hematocrit , hemoglobin or lymphocyte count status .
CONCLUSIONS	Results suggest that the need-based nutritional intervention can be a practical and useful strategy for improving the nutritional status of persons living in nursing homes and save on healthcare cost .
CONCLUSIONS	The potential application of this strategy deserves the attention of health planners .

###19233881
BACKGROUND	The Berci-Kaplan video laryngoscope was developed to improve the visualization of the glottis and ease tracheal intubation .
BACKGROUND	Whether this technique is also effective in patients with an expected difficult intubation is unclear .
BACKGROUND	We have prospectively evaluated the conditions and success rate of tracheal intubation in patients with a Mallampati score of III or IV .
METHODS	Two hundred patients , undergoing general anaesthesia , were randomized to be intubated using direct laryngoscopy ( n = 100 ) or video laryngoscopy ( n = 100 ) .
METHODS	Visualization of the vocal cords , success rate , time for intubation , and the need for additional manoeuvres ( laryngeal manipulations , head positioning , and Eschmann stylet ) were evaluated .
RESULTS	Video laryngoscopy produced better results for the visualization of the glottis using Cormack and Lehane criteria ( P < 0.001 ) , success rate ( n = 92 vs 99 , P = 0.017 ) , and the time for intubation [ 60 ( 77 ) vs 40 ( 31 ) s , P = 0.0173 ] .
RESULTS	In addition , the number of optimizing manoeuvres was also significantly decreased [ 1.2 ( 1.3 ) vs 0.5 ( 0.7 ) , P < 0.001 ] .
CONCLUSIONS	Video laryngoscopy , when compared with direct laryngoscopy for difficult intubations , provides a significantly better view of the cords , a higher success rate , faster intubations , and less need for optimizing manoeuvres .
CONCLUSIONS	Therefore , we feel that the video laryngoscopy leads to a clinically relevant improvement of intubation conditions and can be recommended for difficult airway management .

###16953019
OBJECTIVE	To determine whether infants of women randomized to a prenatal and postpartum lactation support intervention incur fewer otitis media - , respiratory tract - , or gastrointestinal-related visits than controls .
METHODS	Randomized , unmasked controlled trial recruiting women from prenatal care settings .
METHODS	Breastfeeding sensitive ( BFS ) illness visits for otitis media or respiratory tract or gastrointestinal complaints were obtained up to 12 months .
METHODS	Two urban community health centers .
METHODS	Analytic sample of 338 low-income , primarily Hispanic and/or black mother-infant dyads ( n = 163 for the intervention group and n = 175 for the control group ) .
METHODS	Study lactation consultants attempted 2 prenatal meetings , 1 postpartum hospital and/or home visit , and telephone calls as needed .
METHODS	Controls received the standard of care .
METHODS	Combined outpatient and emergency department visits with illness and BFS illness diagnoses .
RESULTS	There was a significant interaction between treatment and Medicaid ; among those not receiving Medicaid , the number of otitis media visits was higher among controls ( P < / = .03 ) .
RESULTS	Visits for any illness and BFS , gastrointestinal , or respiratory tract illnesses did not differ by treatment group .
RESULTS	Intervention group infants received more breast milk than controls , but exclusive breastfeeding rates remained low and did not differ between groups at any point .
CONCLUSIONS	Only the number of otitis media visits was reduced , in a subset of the intervention group .
CONCLUSIONS	The intervention did not reduce visits for respiratory tract or gastrointestinal illness .
CONCLUSIONS	Limited intervention contact and low exclusive breastfeeding rates may have attenuated intervention effects .
CONCLUSIONS	Future interventions designed to yield markedly increased breastfeeding rates may show greater effects in low-income multiethnic samples .
CONCLUSIONS	Health coverage for visits may moderate intervention effects .

###16730606
OBJECTIVE	Although an adult model of patient-provider mutual exchange of information has been proposed , there is no guiding model for adolescents or measurement methodology .
OBJECTIVE	Our purpose was to develop a new scale of patient-provider interaction for adolescents accessing reproductive health care and at risk for sexually transmitted diseases ( STDs ) and human immunodeficiency virus ( HIV ) , and assess the reliability and validity of the scale .
METHODS	The Adolescent Patient-Provider Interaction Scale ( APPIS ) was developed from the Roter and Hall theory of doctor-patient relationships , previously validated adolescent satisfaction and communication scales , and focus group and individual elicitation interviews .
METHODS	To assess construct validity , the new nine-item APPIS was compared with the satisfaction scale used by the Young Adult Health Care Survey ( YAHCS ) , and Kahn 's Provider Communication Scale .
METHODS	Pearson correlation coefficients were used to examine convergence across scales , and factor analysis of the APPIS was performed .
RESULTS	The study recruited 192 African American girls aged 17.9 + / - 1.7 years ( range 15-21 years ) from three sites : a county STD clinic ( n = 51 ) , urban adolescent clinic ( n = 99 ) , and a family planning clinic ( n = 42 ) .
RESULTS	Most participants ( 85 % ) rated their overall health care highly ( > or = 7 on a 10-point scale ) ; 49 % felt that both the provider and patient were `` in charge '' of the visit , and 88 % `` strongly agreed '' or `` agreed '' that there was an equal `` exchange of information '' during the visit .
RESULTS	The APPIS showed good internal consistency ( Cronbach alpha = .75 ) , and moderate convergence with the six-item YAHCS scale ( r = .57 , p < .001 ) and seven-item Kahn scale ( r = .48 , p < .001 ) .
RESULTS	Three factors emerged from exploratory factor analyses , supporting our conceptualization of patient-provider interaction as being multi-dimensional .
CONCLUSIONS	A new theory-based scale of adolescent patient-provider interaction compares favorably with previous scales of health care satisfaction and communication .
CONCLUSIONS	The new APPIS may be useful for evaluating approaches to improve health care outcomes for adolescents at-risk for STDs and HIV .

###24354616
BACKGROUND	A proposal has recently been made regarding the potential adjuvant use of platelet-rich plasma ( PRP ) with fractional carbon dioxide laser ( FCL ) for the correction of acne scars .
OBJECTIVE	To compare the efficacy and safety of two administration modes of autologous PRP ( intradermal injection ( ID ) and topical application ) after FCL with that of FCL alone in the treatment of atrophic acne scars .
METHODS	Thirty patients were randomly divided into two groups .
METHODS	Both underwent split-face therapy .
METHODS	Group 1 was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other .
METHODS	In group 2 , one cheek was treated with FCL followed by ID PRP , and the other received FCL followed by topical PRP .
METHODS	Each patient received 3monthly sessions .
METHODS	The final assessment took place at 6months .
RESULTS	Combined PRP - and FCL-treated areas had a significantly better response ( p = .03 ) , fewer side effects , and shorter downtime ( p = .02 ) than FCL-treated areas , but there were no significant differences in ID - and topical PRP-treated areas in degree of response and downtime ( p = .10 ) ; topically treated areas had significantly lower pain scores .
CONCLUSIONS	The current study introduces the combination of topical PRP and FCL as an effective , safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP .

###12072038
OBJECTIVE	Despite strong observational evidence for a beneficial role of oestrogen in cardiovascular disease , recent trial results suggest that hormone replacement therapy ( HRT ) may have adverse effects in menopausal women with established coronary heart disease .
OBJECTIVE	Isoflavones are oestrogen analogues found in plants with oestrogen-like properties and , because of a favourable side-effect profile , may be ideal alternatives to HRT with respect to cardiovascular benefits .
OBJECTIVE	Endothelial function is a marker of cardiovascular health .
OBJECTIVE	We aimed to determine the effect of isoflavones on endothelial function using the brachial artery reactivity test .
METHODS	Twenty-nine healthy menopausal women underwent entry and exit brachial artery reactivity testing following randomization to 2 weeks of an oral soy isoflavone concentrate containing 80 mg of soy isoflavones ( Archer Daniel Midland Inc. , IL , USA ) or placebo .
RESULTS	At study exit , there was no difference between placebo and isoflavone groups with respect to flow-mediated dilation ( % FMD ( max ) ) , change ( entry to exit ) in % FMD ( max ) or response to nitroglycerine ( % TNG ) .
RESULTS	Subgroup analyses assessing lipid and oestrogen effects did not produce any significant results .
CONCLUSIONS	These results suggest that short-term oral isoflavone supplements do not improve endothelial function in healthy menopausal women .

###8790131
OBJECTIVE	To evaluate the effects of health supervision structured encounter forms on pediatric house staff knowledge , parent satisfaction , and quality of care .
METHODS	Randomized , controlled trial .
METHODS	Pediatric house staff continuity clinic in a university-based children 's hospital .
METHODS	53 pediatric house officers and 153 parents .
METHODS	House staff were randomized to use structured encounter forms focused on developmental milestones ( group 1 ) or anticipatory guidance/preventive care ( group 2 ) during health supervision visits .
METHODS	Changes in house staff knowledge were assessed with pretests and posttests .
METHODS	Parent satisfaction was assessed with surveys .
METHODS	Quality of care , defined as compliance with recommended guidelines for age-specific health supervision , was assessed by audiotaping visits .
RESULTS	Group 1 demonstrated greater but not significantly different improvement in knowledge of developmental milestones than group 2 , while group 2 improved more than group 1 in knowledge of anticipatory guidance / preventive care .
RESULTS	Parent satisfaction with developmental screening was significantly greater for group 1 visits than for group 2 visits ( P < .001 ) .
RESULTS	Group 1 demonstrated significantly greater compliance than group 2 with recommended standards of developmental screening ( P = .001 ) .
CONCLUSIONS	The use of structured encounter forms for health supervision in pediatric house staff continuity clinics may increase house staff knowledge of developmental milestones and anticipatory guidance/preventive care , increases parent satisfaction with developmental assessment during health supervision , and improves compliance with recommended guidelines for developmental assessment .

###20392706
BACKGROUND	Levels of physical exercise among haemodialysis patients are low .
BACKGROUND	Increased physical activity in this population has been associated with improved health-related quality of life ( HRQoL ) and survival .
BACKGROUND	However , results of previous studies may not be applicable to the haemodialysis population as a whole .
BACKGROUND	The present study provides the first description of international patterns of exercise frequency and its association with exercise programmes and clinical outcomes among participants in the Dialysis Outcomes and Practice Patterns Study ( DOPPS ) .
METHODS	Data from a cross section of 20,920 DOPPS participants in 12 countries between 1996 and 2004 were analysed .
METHODS	Regular exercise was defined as exercise frequency equal to or more than once/week based on patient self-report .
METHODS	Linear mixed models and logistic regression assessed associations of exercise frequency with HRQoL and other psychosocial variables .
METHODS	Mortality risk was calculated in Cox proportional hazard models using patient-level ( patient self-reported exercise frequency ) and facility-level ( the dialysis facility percentage of regular exercisers ) predictors .
RESULTS	Regular exercise frequency varied widely across countries and across dialysis facilities within a country .
RESULTS	Overall , 47.4 % of participants were categorized as regular exercisers .
RESULTS	The odds of regular exercise was 38 % higher for patients from facilities offering exercise programmes ( adjusted odds ratio = 1.38 [ 95 % confidence interval : 1.03-1 .84 ] ; P = 0.03 ) .
RESULTS	Regular exercisers had higher HRQoL , physical functioning and sleep quality scores ; reported fewer limitations in physical activities ; and were less bothered by bodily pain or lack of appetite ( P < or = 0.0001 for all ) .
RESULTS	Regular exercise was also correlated with more positive patient affect and fewer depressive symptoms ( P < or = 0.0001 ) .
RESULTS	In models extensively adjusted for demographics , comorbidities and socio-economic indicators , mortality risk was lower among regular exercisers ( hazard ratio = 0.73 [ 0.69-0 .78 ] ; P < 0.0001 ) and at facilities with more regular exercisers ( 0.92 [ 0.89-0 .94 ] ; P < 0.0001 per 10 % more regular exercisers ) .
CONCLUSIONS	Results from an international study of haemodialysis patients indicate that regular exercise is associated with better outcomes in this population and that patients at facilities offering exercise programmes have higher odds of exercising .
CONCLUSIONS	Dialysis facility efforts to increase patient physical activity may be beneficial .

###18307459
OBJECTIVE	The superiority of continuous subcutaneous insulin infusion ( CSII ) over multiple daily injections ( MDI ) with glargine is uncertain .
OBJECTIVE	In this randomized cross-over study , we compared CSII and MDI with glargine in patients with Type 1 diabetes well controlled with CSII .
OBJECTIVE	The primary end-point was glucose variability .
METHODS	Thirty-nine patients [ 38.1 + / - 9.3 years old ( mean + / - sd ) , diabetes duration 16.6 + / - 8.2 years , glycated haemoglobin ( HbA ( 1c ) ) 7.6 + / - 0.8 % ] , already on CSII for at least 6 months , were randomly assigned to CSII with lispro or MDI with lispro and glargine .
METHODS	After 4 months they were switched to the alternative treatment .
METHODS	During the last month of each treatment blood glucose variability was analysed using glucose standard deviation , mean amplitude of glycaemic excursions ( MAGE ) , lability index and average daily risk range ( ADRR ) .
METHODS	As secondary end-points we analysed blood glucose profile , HbA ( 1c ) , number of episodes of hypo - and hyperglycaemia , lipid profile , free fatty acids ( FFA ) , growth hormone and treatment satisfaction .
RESULTS	During CSII , glucose variability was 5-12 % lower than during MDI with glargine .
RESULTS	The difference was significant only before breakfast considering glucose standard deviation ( P = 0.011 ) , significant overall using MAGE ( P = 0.016 ) and lability index ( P = 0.005 ) and not significant using ADRR .
RESULTS	Although HbA ( 1c ) was similar during both treatments , during CSII blood glucose levels were significantly lower , hyperglycaemic episodes were fewer , daily insulin dose was less , FFA were lower and treatment satisfaction was greater than during MDI with glargine .
RESULTS	The frequency of hypoglycaemic episodes was similar during both treatments .
CONCLUSIONS	During CSII , glucose variability is lower , glycaemic control better and treatment satisfaction higher than during MDI with glargine .

###24315625
BACKGROUND	To examine the association between baseline body mass index ( BMI ) , and disease-free survival ( DFS ) and overall survival ( OS ) in a large French early-stage breast cancer population included in the UNICANCER Programme d'Action Concert Sein-01 ( PACS01 ) and PACS04 phase III randomised trials .
METHODS	After a median follow-up of 5.9 years , this report analyses 4996 patients with node-positive breast cancer , and randomly assigned to adjuvant anthracycline-based chemotherapy combined or not with taxanes .
METHODS	Univariate analyses were used to study the effects of well known prognostic factors and BMI on DFS and OS .
METHODS	BMI was obtained at baseline , before chemotherapy initiation , and obesity was defined as a BMI30kg/m ( 2 ) .
METHODS	Cox proportional hazards regression models were secondly used to assess the influence of BMI after adjusting for other factors .
METHODS	Exhaustive analysis of the dose intensity delivered was also studied for comparison between obese and non-obese patients .
RESULTS	Obese patients initially present with more advanced disease at diagnosis compared to non-obese patients .
RESULTS	By univariate analysis , obesity was moderately associated with poorer DFS ( hazard ratio ( HR ) = 1.18 [ 1.01-1 .39 ] P = 0.04 ) , but mostly with poorer OS ( HR = 1.38 [ 1.13-1 .69 ] P = 0.002 ) .
RESULTS	Delivered dose intensity of anthracyclines and taxanes was not significantly different between obese and non-obese patients .
RESULTS	After adjustment for disease characteristics , BMI had no influence either on DFS or OS .
CONCLUSIONS	This report suggests that in a French population , obesity has no impact on breast cancer prognosis when modern adjuvant chemotherapy , at the appropriate dose intensity , is delivered .

###16449106
OBJECTIVE	To compare transcervical Foley bulb with and without extra-amniotic saline infusion for induction of labor in patients with an unfavorable cervix .
METHODS	Women who presented for induction of labor with Bishop score less than 5 were randomly assigned to receive Foley alone or Foley with extra-amniotic saline infusion for induction of labor .
METHODS	Primary outcome was time from start of induction to vaginal delivery .
METHODS	Secondary outcomes were cesarean delivery rates , incidence of chorioamnionitis , Apgar scores at 1 and 5 minutes , and adverse events .
RESULTS	One hundred forty women completed the study .
RESULTS	Time from induction to vaginal delivery was 16.58 ( + / - 7.55 ) hours in the extra-amniotic saline infusion group compared with 21.47 ( + / - 9.95 ) hours in the Foley group ( P < .01 ) .
RESULTS	Chorioamnionitis occurred in 4 of 66 ( 6.1 % ) women in the extra-amniotic saline infusion group compared with 12 of 74 ( 16.2 % ) women in the Foley group ( P = .067 ) .
RESULTS	Cesarean delivery rate was 21.2 % versus 20.1 % in the extra-amniotic saline infusion and Foley groups , respectively ( P = 1.0 ) .
RESULTS	Median 1-minute and 5-minute Apgar scores were 9 in both groups .
RESULTS	Adverse events were rare and unrelated to method of induction .
CONCLUSIONS	Induction of labor by using Foley with extra-amniotic saline infusion results in shorter induction-to-vaginal-delivery time than Foley alone , without affecting cesarean delivery rates .
METHODS	II-I

###14612828
OBJECTIVE	To investigate whether colour Doppler US can demonstrate haemodynamic differences in patients with renal colic after pharmacological treatment with indomethacin and ketorolac .
METHODS	We studied 180 consecutive patients with unilateral acute renal colic with colour Doppler US ; 90 were treated with indomethacin , 90 with ketorolac .
METHODS	Furthermore , 37 consecutive patients without obstruction ( 17 treated with indomethacin and 20 with ketorolac ) were also examined and considered normal controls .
RESULTS	In the patients with renal colic the average resistive index ( RI ) was significantly greater on the side of the colic after administration of either indomethacin or ketorolac ( p < 0.001 ) .
RESULTS	The average RI in the obstructed kidneys was significantly higher in the patients treated with ketorolac than with indomethacin ( p < 0.005 ) .
RESULTS	No statistically significant differences were shown between the average RIs of the non obstructed kidneys of the patients with renal colic and between the kidneys of the control patients treated with either indomethacin or ketorolac .
CONCLUSIONS	Doppler evaluation of patients with renal colic requires careful interpretation after the administration of nonsteroidal anti-inflammatory drugs ( NSAIDs ) , since values of renal RI depend on the drug that has been used to relieve symptoms .

###10100652
OBJECTIVE	Ruby laser energy at 694 mn is moderately absorbed by melanin and minimally absorbed by other skin chromophores .
OBJECTIVE	This property and its depth of penetration into dermis permit absorption into pigmented hair follicles , thus making it suited to photothermolysis of these appendages .
OBJECTIVE	Clinical reports of the efficacy of such lasers for removal of unwanted hair are emerging in large numbers , but scientific data regarding the exact mechanism of action is still lacking .
OBJECTIVE	This study aims to evaluate and define further the histological responses of hair follicles to 3-msec pulsed ruby laser light .
METHODS	Twenty-four patients with brown or black axillary or groin hair were treated with a 3-msec ruby laser at fluences from 10 to 40 J/cm2 on one , two , or three occasions .
METHODS	Biopsies were taken at various intervals from immediately to 8 weeks after treatments .
METHODS	Biopsies were fixed and stained with either nitroblue tetrazolium chloride or hematoxylin and eosin for histological examination .
RESULTS	One treatment induced changes typical of catagen followed by telogen at all fluences .
RESULTS	The papillae always remained viable .
RESULTS	Two and three treatments resulted in atypical telogen , with infundibular dilatation and plugging , and marked proliferation of the stem outer sheath .
RESULTS	New anagen follicles were evident even after three treatments at 12 - and then 8-week intervals and were biopsied 6 weeks later , but there were no hairs extending to or through the epidermis .
CONCLUSIONS	There was no evidence of permanent follicle death after one ruby laser treatment .
CONCLUSIONS	However , despite evidence of persistence of follicular elements after two and three treatments , it is possible that laser-induced damage to the isthmus and upper stem may interfere with the interaction between dermal and epidermal germinative cells , thus inhibiting or altering the normal hair cycle .

###26054185
OBJECTIVE	A double blind , randomized , unsupervised , parallel-group clinical trial was conducted on over 5,500 children in Sichuan Province , China .
OBJECTIVE	This clinical trial compared the anti-caries efficacy of two test dentifrices to that of a control dentifrice .
METHODS	The test dentifrices contained 1.5 % arginine , 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) , and an insoluble calcium compound ( either dicalcium phosphate or calcium carbonate ) .
METHODS	The positive control dentifrice contained 1450 ppm fluoride as sodium fluoride ( NaF ) , in a silica base .
METHODS	The children were randomly assigned one of the toothpastes , and children residing in the same household were assigned the same dentifrice to use at home , twice a day .
RESULTS	Three calibrated dentists examined the children at baseline , as well as after one and two years of product use .
RESULTS	After one year of product use , there were no statistically significant differences among the three groups with respect to decayed , missing , and filled teeth ( DMFT ) or to decayed , missing , and filled surfaces ( DMFS ) .
RESULTS	After two years of product use , subjects in the two test groups using the dentifrices containing 1.5 % arginine , 1450 ppm fluoride as MFP , and an insoluble calcium compound had a statistically significant reduction in DMFT increments of 20.5 % and in DMFS increments of 19.6 % when compared to subjects in the group using the positive control dentifrice .
RESULTS	After two years , there were no statistically significant differences with respect to DMFT or DMFS between the two groups using the dentifrices containing 1.5 % arginine , 1450 ppm fluoride as MFP , and an insoluble calcium compound .
CONCLUSIONS	The use of the two test dentifrices demonstrated significant reductions in decayed , missing , and filled teeth and surfaces , however there was no statistically significant different between the two test dentifrices clinically after two years of using the toothpastes .
CONCLUSIONS	The results of this two-year clinical investigation support the conclusion that dentifrices containing 1.5 % arginine , an insoluble calcium compound , and 1450 ppm fluoride as MFP provide superior protection against caries lesion cavitation compared to a positive control dentifrice containing only 1450 ppm fluoride as NaF .

###9778066
BACKGROUND	A study was conducted to determine the efficacy and safety of ibutilide fumarate versus placebo in the acute termination of atrial flutter and fibrillation .
RESULTS	Two hundred sixty-two patients aged 28 to 88 years with atrial flutter or fibrillation duration of 3 hours to 90 days were randomly assigned in a 5:1 ratio ( ibutilide : placebo ) to receive two 10-minute infusions , 10 minutes apart , of ibutilide ( 1 mg ) or placebo .
RESULTS	Patients were hospitalized and monitored by telemetry for 24 hours , with follow-up 72 hours later .
RESULTS	Seventy-three ( 34.9 % ) of 209 evaluable ibutilide recipients had termination of atrial flutter or fibrillation within 1.5 hours compared with 0 ( 0 % ) of 41 placebo recipients .
RESULTS	Those with atrial flutter had a higher success rate .
RESULTS	At hour 24 , 86.3 % remained in normal or alternative sinus rhythm .
RESULTS	Of the patients who received ibutilide , 2.3 % experienced drug-related sustained polymorphic or monomorphic ventricular tachycardia and recovered after intervention .
RESULTS	Additionally , 7.3 % experienced nonsustained polymorphic or monomorphic ventricular tachycardia .
RESULTS	Other frequent medical events in ibutilide recipients were generally also noted in the placebo group .
CONCLUSIONS	Ibutilide is effective and safe for acute termination of atrial fibrillation or atrial flutter .

###8239103
OBJECTIVE	To examine the hypothesis that an IM long-acting steroid injection will decrease the relapse rate of asthma patients .
METHODS	A randomized , single-blind , placebo-controlled trial .
METHODS	The emergency department of an urban academic medical center .
METHODS	Acute asthma patients aged 18 to 45 years who were treated successfully in the ED .
METHODS	Participants received either IM saline placebo or 240 mg methylprednisolone acetate suspension at the time of discharge .
METHODS	MEASUREMENTS AND MAIN OUTCOME : Relapse , defined as the need to seek nonroutine medical care for asthma within seven days of discharge , was the main outcome measure .
METHODS	Of 70 patients entered , 56 ( 80 % ) completed follow-up , including 30 in the steroid group and 26 in the placebo group .
METHODS	The groups had similar characteristics and peak expiratory flow values on arrival and at discharge .
METHODS	Relapse occurred in two steroid patients ( 6.7 % ) and eight placebo recipients ( 30.8 % ) ( P < .05 ) .
METHODS	There was one death in the placebo group .
METHODS	Reported side effects were similar .
CONCLUSIONS	IM long-acting steroids reduced the rate of relapse in patients with acute asthma .

###22590982
OBJECTIVE	The aim of this article was to explore the effect of duration of breastfeeding on neurocognitive development .
METHODS	The long-term effect of breastfeeding on neurodevelopment was examined through a battery of neuropsychological tests in 1403 children ( 693 females , 710 males ; mean age 11 y 9mo [ SD 6mo ] , range : 10y 3mo-12y 8mo ) who were originally recruited at 6 to 12 weeks of age for a clinical trial on acellular pertussis vaccines .
METHODS	An estimated IQ was obtained from scores of the vocabulary , similarities , block design , and coding tests .
METHODS	Breastfeeding data had been prospectively collected throughout the first year of life .
METHODS	Duration of exclusive breastfeeding was defined as the time during which children received breast milk without receiving any supplemental formula or food .
METHODS	Children were assessed at 10 to 12 years of age .
METHODS	We adjusted the analysis on test scores for multiple potential confounders .
RESULTS	Multivariate analysis showed a significant association between exclusive breastfeeding duration and test scores in the vocabulary ( odds ratio [ OR ] 0.05 ; confidence interval [ CI ] 0.00-0 .10 ; p = 0.04 ) and similarities ( OR 0.06 ; CI 0.01-0 .11 ; p = 0.03 ) tests .
RESULTS	These associations have a negligible effect size , however .
RESULTS	Scores on one writing praxis test subcategory decreased with increasing duration of both exclusive breastfeeding ( OR -0.06 ; CI -0.11 to -0.01 ; p = 0.03 ) and breastfeeding irrespective of consumption of other foods ( OR -0.06 ; CI -0.11 to -0.01 ; p = 0.03 ) .
RESULTS	A negative association was also found between one subcategory of the California verbal learning test and breastfeeding duration longer than 6 months ( OR -0.21 ; CI -0.42 to -0.01 ; p = 0.04 ) .
CONCLUSIONS	Breastfed healthy children may perform better on neuropsychological tests in the language domain at 10 to 12 years of age .
CONCLUSIONS	However , the effect of breast milk on neuropsychological performance in healthy children may have a limited clinical relevance and is confounded by parental education .

###10367574
OBJECTIVE	To evaluate predicted optical quality of the central anterior corneal surface before and after the intrastromal corneal ring segment ( ICRS ) refractive procedure using a clinical videokeratoscope and software index developed for that purpose .
METHODS	Predicted corneal acuity , a topographically derived index provided with the EyeSys System 2000 videokeratscope , representing potential optical quality of the cornea , was assessed preoperatively and at postoperative month 3 in 94 eyes that received an ICRS to treat -1.00 to -6.00 D of myopia .
METHODS	Predicted corneal acuity was calculated by determining the difference between a measured cornea and its best-fit ellipses for reflected ring circumferences within the central 3 mm diameter zone .
RESULTS	Preoperative predicted corneal acuity was 20/10 in 92 of 94 eyes ( 98 % ) .
RESULTS	At month 3 after the ICRS procedure , 48 ( 51 % ) of moderately myopic eyes were corrected to 20/20 or better , 96 % ( 90 eyes ) were corrected to 20/40 or better , and 98 % of eyes ( 92 eyes ) had a predicted corneal acuity of 20/10 .
RESULTS	For the eyes with a predicted corneal acuity of 20/10 , spectacle-corrected visual acuity was normally distributed between 20/10 and 20/25 .
CONCLUSIONS	Predicted corneal acuity did not change significantly from baseline in eyes with an ICRS .
CONCLUSIONS	This suggests that topographic irregularities in the central 3 mm of the cornea detectable by predicted corneal acuity software were not induced in the central cornea with the ICRS .

###22734945
BACKGROUND	The Healthy Options for Nutrition Environments in Schools ( Healthy ONES ) study was an evidence-based public health ( EBPH ) randomized group trial that adapted the Institute for Healthcare Improvement 's ( IHI ) rapid improvement process model to implement school nutrition policy and environmental change .
METHODS	A low-income school district volunteered for participation in the study .
METHODS	All schools in the district agreed to participate ( elementary = 6 , middle school = 2 ) and were randomly assigned within school type to intervention ( n = 4 ) and control ( n = 4 ) conditions following a baseline environmental audit year .
METHODS	Intervention goals were to 1 ) eliminate unhealthy foods and beverages on campus , 2 ) develop nutrition services as the main source on campus for healthful eating ( HE ) , and 3 ) promote school staff modeling of HE .
METHODS	Schools were followed across a baseline year and two intervention years .
METHODS	Longitudinal assessment of height and weight was conducted with second , third , and sixth grade children .
METHODS	Behavioral observation of the nutrition environment was used to index the amount of outside foods and beverages on campuses .
METHODS	Observations were made monthly in each targeted school environment and findings were presented as items per child per week .
RESULTS	From an eligible 827 second , third , and sixth grade students , baseline height and weight were collected for 444 second and third grade and 135 sixth grade students ( 51 % reach ) .
RESULTS	Data were available for 73 % of these enrolled students at the end of three years .
RESULTS	Intervention school outside food and beverage items per child per week decreased over time and control school outside food and beverage items increased over time .
RESULTS	The effects were especially pronounced for unhealthy foods and beverage items .
RESULTS	Changes in rates of obesity for intervention school ( 28 % baseline , 27 % year 1 , 30 % year 2 ) were similar to those seen for control school ( 22 % baseline , 22 % year 1 , 25 % year 2 ) children .
CONCLUSIONS	Healthy ONES adaptation of IHI 's rapid improvement process provided a promising model for implementing nutrition policy and environmental changes that can be used in a variety of school settings .
CONCLUSIONS	This approach may be especially effective in assisting schools to implement the current federally-mandated wellness policies .

###23170936
OBJECTIVE	Central obesity and insulin resistance are key components of the metabolic syndrome , which is associated with an increased risk of cardiovascular disease .
OBJECTIVE	In obesity , CC chemokines , such as monocyte chemotactic protein-1 ( MCP-1 ) , macrophage inhibitory protein-1 ( MIP-1 ) and eotaxin-1 and their respective receptors , are critically involved in peripheral monocyte activation and adipose tissue infiltration .
OBJECTIVE	The aim of the current study was to examine whether low-dose atorvastatin ( 10 mg/d ) treatment modulated serum levels of CC chemokines in metabolic syndrome subjects .
METHODS	Serum levels of MCP-1 , eotaxin-1 , MIP-1 , C reactive protein ( CRP ) and interleukin-6 ( IL-6 ) were measured in lean control and metabolic syndrome subjects at baseline , and following a 6-week randomized placebo-controlled clinical trial of atorvastatin ( 10 mg/d ) .
METHODS	Peripheral CD14 ( + ) monocytes were isolated and mRNA levels of MCP-1 , MIP-1 and CCR5 determined .
RESULTS	Serum MCP-1 ( P = 002 ) , eotaxin-1 ( P = 002 ) and MIP-1 ( P = 003 ) , CRP ( P < 0001 ) and IL-6 ( P = 0006 ) were significantly increased in metabolic syndrome in comparison with lean controls .
RESULTS	Furthermore , CD14 ( + ) peripheral monocyte mRNA expression of the chemokine receptor , CCR5 , of which MIP-1 and eotaxin-1 are ligands , was increased two-fold in the metabolic syndrome group ( P = 003 ) .
RESULTS	In addition to the expected improvements in lipid profile , atorvastatin treatment significantly reduced circulating eotaxin-1 ( P < 005 ) , MIP-1 ( P < 005 ) levels and CD14 ( + ) peripheral monocyte CCR5 mRNA expression ( P = 002 ) .
CONCLUSIONS	These results support a model whereby atorvastatin treatment , by inhibiting CD14 ( + ) monocyte CCR5 expression , may inhibit monocyte trafficking , reduce chronic inflammation and , thus , lower circulating levels of CC chemokines .

###9142004
BACKGROUND	Sudden hypotension in progressive hypovolemia or during hemodialysis is attributed to sudden inhibition of sympathetic activity .
BACKGROUND	Critical ventricular underfilling seems responsible for this paradox , but it is unknown why the transition from sympathoactivation accompanying hypovolemia to sympathoinhibition is so abrupt .
BACKGROUND	We studied whether brief fluctuation of sympathetic activity induced by cold pressor test ( CPT ) evokes sympathoinhibition if applied during low cardiac output .
RESULTS	Fourteen healthy subjects underwent CPT , lower-body negative pressure ( LBNP ; -45 mm Hg for 60 minutes ) , or the combination thereof .
RESULTS	CPT alone caused vasoconstriction and increased muscle sympathetic nerve activity , followed by uneventful relaxation .
RESULTS	When applied during reduced cardiac output , tachycardia , and vasoconstriction induced by prior LBNP for 6 minutes , CPT again caused vasoconstriction , now followed by acute hypotension in 10 subjects , and was associated with vasorelaxation , relative bradycardia , and fall in muscle sympathetic nerve activity .
RESULTS	Eight subjects also experienced acute LBNP-induced hypotension in the absence of CPT , but not until 17 + / - 6 minutes of LBNP .
RESULTS	We also performed CPT before and in the final phase of hemodialysis in 8 patients .
RESULTS	Before dialysis , the patients tolerated CPT uneventfully , but during hemodialysis , CPT provoked acute hypotension in 5 cases , showing similar withdrawal of vasoconstriction .
CONCLUSIONS	This is the first study showing that brief cold stress , tolerated well in normal circulatory conditions , can provoke sudden sympathoinhibition and hypotension when applied during decreased cardiac output induced by LBNP or hemodialysis .
CONCLUSIONS	We suggest that during conditions of a decreased cardiac output , subtle sympathetic relaxation such as follows cold stress triggers self-enhancing relaxation that can not be controlled .

###22508468
OBJECTIVE	To assess whether it is better to intensively treat all patients with early rheumatoid arthritis ( RA ) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response ( as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [ DAS28-ESR ] of 3.2 at week 24 ) to methotrexate ( MTX ) monotherapy , and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine .
METHODS	The Treatment of Early Aggressive Rheumatoid Arthritis ( TEAR ) study is a 2-year , randomized , double-blind trial .
METHODS	A 2 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms : immediate treatment with MTX plus etanercept , immediate oral triple therapy ( MTX plus sulfasalazine plus hydroxychloroquine ) , or step-up from MTX monotherapy to one of the combination therapies ( MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine ) at week 24 if the DAS28-ESR was 3.2 .
METHODS	All treatment arms included matching placebos .
METHODS	The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102 .
RESULTS	At week 24 ( beginning of the step-up period ) , subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups ( 3.6 versus 4.2 ; P < 0.0001 ) ; no differences between the combination-therapy regimens were observed .
RESULTS	Between week 48 and week 102 , subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy , regardless of the treatment arm .
RESULTS	There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept .
RESULTS	By week 102 , there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy ( 0.64 versus 1.69 ; P = 0.047 ) .
CONCLUSIONS	There were no differences in the mean DAS28-ESR during weeks 48-102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy , regardless of whether they received immediate combination treatment or step-up from MTX monotherapy .
CONCLUSIONS	At 102 weeks , immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step-up therapy .
CONCLUSIONS	Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine ( or etanercept , if necessary , after 6 months ) is a reasonable therapeutic strategy for patients with early RA .
CONCLUSIONS	Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy .

###12491025
BACKGROUND	Studies in non-human animals suggest that opioid antagonists block the reinforcing effects of cannabinoids .
OBJECTIVE	The present studies in humans investigated how naltrexone modulates ( 1 ) the subjective and physiological effects of oral THC in comparison to methadone , ( 2 ) the reinforcing effects of oral THC , and ( 3 ) plasma levels of oral THC .
METHODS	In study 1 , marijuana smokers ( n = 9 ) received naltrexone ( 0 , 50 mg ) followed 30 min later by THC ( 0 , 15 , 30 mg ) or methadone ( 5 , 10 mg ) .
METHODS	Subjective effects , task performance , pupillary diameter , and cardiovascular parameters were measured repeatedly .
METHODS	In study 2a , marijuana smokers ( n = 23 ) were randomly assigned to one THC dose condition ( 0 , 15 or 30 mg ) .
METHODS	One set of color-coded capsules containing THC and active naltrexone ( 50 mg ) was given in one session , while another set of color-coded capsules containing THC and placebo naltrexone was given in another session .
METHODS	In the final three sessions , participants chose which color capsules they would receive .
METHODS	In study 2b , a subset of participants from study 2a ( n = 7 ) received naltrexone ( 0 , 50 mg ) 30 min prior to oral THC ( 30 mg ) administration , and blood was drawn repeatedly .
RESULTS	Pretreatment with naltrexone significantly increased many of the `` positive '' subjective effects of oral THC ( 30 mg ) e.g. ratings of Good Drug Effect and Capsule Liking .
RESULTS	Naltrexone tended to increase the reinforcing effects of oral THC ( 30 mg ) , as indicated by performance in a drug choice test .
RESULTS	Naltrexone did not alter plasma THC levels .
CONCLUSIONS	These studies demonstrate that naltrexone increases the subjective effects of oral THC .
CONCLUSIONS	Thus , oral THC 's effects are enhanced rather than antagonized by opioid receptor blockade in heavy marijuana smokers .

###15381643
BACKGROUND	The utility of N-terminal proBNP ( NT-proBNP ) to predict the occurrence of death and hospitalization was prospectively evaluated in the COPERNICUS study , which enrolled patients with an ejection fraction < 25 % and symptoms of chronic congestive heart failure at rest or on minimal exertion .
RESULTS	Baseline plasma concentrations of NT-proBNP were measured in a subgroup of 814 men and 197 women with symptoms at rest or on minimal exertion who were enrolled in the COPERNICUS study and were randomized to placebo ( n = 506 ) or carvedilol ( n = 505 ) .
RESULTS	Values of NT-proBNP were markedly increased despite the requirement that patients be euvolemic before the start of treatment ( mean + / - SD , 3235 + / -4392 pg/mL ; median , 1767 pg/mL ) .
RESULTS	By univariate Cox regression analysis , NT-proBNP was found to be a powerful predictor of subsequent all-cause mortality ( relative risk [ RR ] , 2.7 ; 95 % CI , 1.7 to 4.3 ; P = 0.0001 for above versus below median ) and all-cause mortality or hospitalization for heart failure ( RR , 2.4 ; 95 % CI , 1.8 to 3.4 ; P = 0.0001 for above versus below median ) .
RESULTS	The predictive value of NT-proBNP was similar when both placebo and carvedilol patients were analyzed separately .
RESULTS	No significant interaction was found between NT-proBNP and treatment group ( P = 0.93 for above - versus below-median NT-proBNP ) .
CONCLUSIONS	NT-proBNP was consistently associated with increased risk for all-cause mortality and for all-cause mortality or hospitalization for heart failure in patients with severe congestive heart failure , even in those who were clinically euvolemic .
CONCLUSIONS	This marker therefore may be a useful tool in risk stratification of patients with severe congestive heart failure .

###17664516
OBJECTIVE	Older adults with low incomes rarely use mental health care , and untreated depression is a serious problem in this population .
OBJECTIVE	This study examined whether a collaborative care model for depression in primary care would increase use of depression treatment and treatment outcomes for low-income elderly adults as well as for higher-income older adults .
METHODS	A multisite randomized clinical trial that included 1,801 adults aged 60 years and older who were diagnosed as having depression compared collaborative care for depression with treatment as usual in primary care .
METHODS	Participants were divided into groups by income definitions on the basis of criteria used by the U.S. Census Bureau and the U.S. Department of Housing and Urban Development ( HUD ) .
METHODS	A total of 315 participants ( 18 % ) were living below the poverty level by the U.S. Census criteria , 261 ( 15 % ) were living below 30 % of the area median income ( AMI ) ( HUD criteria ) but above poverty , 438 ( 24 % ) were living between 30 % and 50 % of the AMI , 327 ( 18 % ) were living between 50 % and 80 % of the AMI , and 460 ( 26 % ) were not poor .
METHODS	The income groups were compared on service use , satisfaction , depression severity , and physical health at baseline and at three , six , and 12 months after being randomly assigned to collaborative care or usual care .
RESULTS	The benefits for low-income older adults were similar to those for middle - and higher-income older adults .
RESULTS	At 12 months , intervention patients in all economic brackets had significantly greater rates of depression care for both antidepressant medication and psychotherapy , greater satisfaction , lower depression severity , and less health-related functional impairment than usual care participants .
CONCLUSIONS	Lower-income older adults can experience benefits from collaborative management of depression in primary care similar to those of higher-income older adults , although they may require up to a year to reap physical health benefits .

###11219471
OBJECTIVE	This study was undertaken to compare the efficacy and tolerability of telmisartan , a novel antihypertensive agent , and atenolol , a well-established beta-blocker , in the treatment of mild to moderate hypertension .
METHODS	This 26-week , multicenter , randomized , double-blind , double-dummy , parallel-group , titration-to-response study compared doses of telmisartan ( 40 mg titrated to 80 mg titrated to 120 mg ) with atenolol ( 50 mg titrated to 100 mg ) required to achieve diastolic blood pressure ( DBP ) control ( < or = 90 mm Hg or a decrease from baseline of > or = 10 mm Hg ) .
METHODS	Open-label hydrochlorothiazide ( HCTZ ) 12.5 or 25 mg was added if needed according to a prespecified titration rule .
METHODS	Men and women aged > 18 years with mild to moderate hypertension ( morning mean supine DBP [ SDBP ] > or = 95 mm Hg and < or = 114 mm Hg ) were eligible to participate .
METHODS	Patients with significant cardiovascular , metabolic , hepatic , or renal dysfunction or chronic obstructive pulmonary disease were excluded .
METHODS	The primary efficacy end point was trough SDBP response at 26 weeks ; secondary efficacy end points included changes from baseline at trough in both standing and supine DBP and systolic blood pressure ( SBP ) , and heart rate after 4 , 8 , 16 , and 26 weeks ; SBP control ( reduction from baseline of > or = 10 mm Hg ) ; normalization of supine SDBP to < or = 90 mm Hg ; and the need for add-on HCTZ .
METHODS	Changes in quality of life were also examined .
METHODS	Adverse events were obtained from spontaneous reporting and recorded .
METHODS	Serious adverse events were reported to the sponsor according to predefined timelines .
RESULTS	A total of 533 patients from 49 centers participated .
RESULTS	Patients ' mean age was 57.9 years ( range , 22-79 years ) ; 55.9 % ( 298/533 ) of the population was male and 98.1 % ( 523/533 ) was white .
RESULTS	Of the 533 patients randomly assigned to treatment and included in the safety analysis , 520 ( 97.6 % ) were included in the efficacy analysis ; 346 received telmisartan and 174 received atenolol .
RESULTS	A total of 489 patients ( 91.7 % ) completed the study ( 325 [ 93.9 % ] , telmisartan ; 164 [ 94.2 % ] , atenolol ) .
RESULTS	Full SDBP response ( trough SDBP < or = 90 mm Hg and/or a reduction from baseline of > or = 10 mm Hg ) was observed in 84 % and 78 % of telmisartan - and atenolol-treated patients , respectively ; this difference was not statistically significant .
RESULTS	Final SBP/DBP reductions of 20.9 / 14.4 mm Hg were observed for the telmisartan regimen versus 16.7 / 13.3 mm Hg for the atenolol regimen ; only the difference in SBP was significant ( P = 0.005 ) .
RESULTS	Reduction from baseline in SBP of > or = 10 mm Hg was achieved by 80 % of telmisartan-treated and 68 % of atenolol-treated patients ( P = 0.003 ) .
RESULTS	Adverse events were reported by 52.7 % of patients given telmisartan and 61.2 % of patients given atenolol ; this difference was not statistically significant .
RESULTS	Most events were mild or moderate .
RESULTS	Although fatigue and male impotence were more common in atenolol-treated patients ( 3.4 % and 4.0 % , respectively ) , the incidence of these adverse events was too low to differentiate statistically .
CONCLUSIONS	Telmisartan appears to be at least as effective as atenolol in the treatment of mild to moderate hypertension and may be better tolerated .

###22773180
OBJECTIVE	To assess the relative clinical success of orthokeratology contact lenses ( OK ) and distance single-vision spectacles ( SV ) in children in terms of incidences of adverse events and discontinuations over a 2-year period .
METHODS	Sixty-one subjects 6 to 12 years of age with myopia of - 0.75 to - 4.00 DS and astigmatism 1.00 DC were prospectively allocated OK or SV correction .
METHODS	Subjects were followed at 6-month intervals and advised to report to the clinic immediately should adverse events occur .
METHODS	Adverse events were categorized into serious , significant , and non-significant .
METHODS	Discontinuation was defined as cessation of lens wear for the remainder of the study .
RESULTS	Thirty-one children were corrected with OK and 30 with SV .
RESULTS	A higher incidence of adverse events was found with OK compared with SV ( p < 0.001 ) .
RESULTS	Nine OK subjects experienced 16 adverse events ( 7 significant and 9 non-significant ) .
RESULTS	No adverse events were found in the SV group .
RESULTS	Most adverse events were found between 6 and 12 months of lens wear , with 11 solely attributable to OK wear .
RESULTS	Significantly more discontinuations were found with SV in comparison with OK ( p < 0.05 ) .
CONCLUSIONS	The relatively low incidence of adverse events and discontinuations with OK is conducive for the correction of myopia in children with OK contact lenses .

###23316296
BACKGROUND	A higher resting heart rate is associated with an increased probability of cardiovascular complications and premature death in patients with type 2 diabetes mellitus .
BACKGROUND	The impact of heart rate on the risk of developing microvascular complications , such as diabetic retinopathy and nephropathy , is , however , unknown .
BACKGROUND	The present study tests the hypothesis that a higher resting heart rate is associated with an increased incidence and a greater progression of microvascular complications in patients with type 2 diabetes mellitus .
RESULTS	The relation between baseline resting heart rate and the development of a major microvascular event was examined in 11 140 patients who participated in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) study .
RESULTS	Major microvascular events were defined as a composite of new or worsening nephropathy or new or worsening retinopathy .
RESULTS	Patients with a higher baseline heart rate were at increased risk of a new major microvascular complication during follow-up ( adjusted hazard ratio : 1.13 per 10 beats per minute ; 95 % confidence interval : 1.07-1 .20 ; P < 0.001 ) .
RESULTS	The excess hazard was evident for both nephropathy ( adjusted hazard ratio : 1.16 per 10 beats per minute ; 95 % confidence interval : 1.08-1 .25 ) and retinopathy ( adjusted hazard ratio : 1.11 per 10 beats per minute ; 95 % confidence interval : 1.02-1 .21 ) .
CONCLUSIONS	Patients with type 2 diabetes mellitus who have a higher resting heart rate experience a greater incidence of new-onset or progressive nephropathy and retinopathy .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00145925 .
BACKGROUND	http://www.advance-trial.com/static/html/prehome/prehome.asp .

###18086027
OBJECTIVE	The aim of this study was to compare the caries-preventive effect of two types of sealant modalities and to evaluate whether the caries-preventive effect is related to sealant retention .
OBJECTIVE	A hypothesis was tested in which a glass ionomer sealant , once applied to the occlusal surface , was able to protect the fissure from caries even if the sealant appeared lost at visual inspection .
METHODS	A 3-year randomized split-mouth trial evaluating two sealant modalities was performed at a public health centre in Finland .
METHODS	A chemically curing glass ionomer cement ( GIC ) and light-curing resin-based ( RB ) sealant material were applied randomly to the permanent second molars .
METHODS	Sealant application as a routine treatment procedure was carried out to 599 children in the age group of 12-16 years .
METHODS	Caries rate of the sealed teeth and sealant retention with both materials were analysed by a modified McNemar 's test .
METHODS	The effectiveness , rate difference , and relative risk with both sealant materials were measured .
RESULTS	The difference in caries rate between the two modalities was highly significant .
RESULTS	When compared to the GIC sealant method , the effectiveness of RB sealant method was 74.1 % and the rate difference 3.2 % ( 95 % CI 1.44 % , 4.98 % ) .
RESULTS	The relative risk for RB-sealed surfaces vs. GIC-sealed surfaces of having detectable dentin caries was 0.26 ( 95 % CI 0.12 , 0.57 ) .
RESULTS	The retention rate of sealants was higher with RB than GIC ( P < 0.001 ) .
RESULTS	The effectiveness of the retention rate for RB sealants was 94.8 % and the rate difference 87.2 % ( 95 % CI 83.86 % , 90.50 % ) .
RESULTS	The relative risk during the 3-year study period of having a defective or lost RB sealant was 0.052 ( 95 % CI 0.036 , 0.075 ) when compared to having a defective or lost GIC sealant .
CONCLUSIONS	It is concluded that in preventing dentin caries a RB sealant programme including resealing when necessary was more effective than a single application of GIC .
CONCLUSIONS	The original hypothesis was thus falsified .

###23945213
BACKGROUND	It has long been postulated that the relative abundance of specific nutrients can affect cognitive processes and emotions .
BACKGROUND	Newly described influences of dietary factors on neuronal function and synaptic plasticity have revealed some of the vital mechanisms that could be responsible for the action of diet on brain health and cognitive function .
BACKGROUND	Here , through a double-blind , randomized , placebo-controlled trial , we asked if the newly discovered chicken meat ingredient-168 ( CMI-168 ) could be beneficial to the cognitive function in healthy adults .
METHODS	Normal , healthy subjects were supplemented with either placebo or CMI-168 for 6weeks .
METHODS	The subjects were given a series of cognitive tests to examine their levels of cognitive functioning at the beginning and end of supplementation , as well as two weeks after termination of supplementation .
METHODS	The combination of these tests , namely Digit Span Backwards , Letter-Number Sequencing , and the Rey Auditory Verbal Learning Test ( RAVLT ) , was used to assess the subjects ' attention and working memory .
METHODS	For all comparisons , the probability level of p < 0.05 was taken as statistically significant using repeated measure 2-way ANOVA followed by Bonferroni post-hoc test .
RESULTS	Overall , subjects supplemented with CMI-168 showed significantly ( p < 0.01 ) better performance in all cognitive tests after 6weeks ' supplementation compared to control and such superior performance was maintained even 2weeks after termination of supplementation .
CONCLUSIONS	The present study reveals the cognition-enhancing properties of a recently developed chicken meat ingredient , likely arising from the promotion of attention and prefrontal cortex functions .

###25184863
BACKGROUND	The combination melphalan-prednisone-thalidomide ( MPT ) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation .
BACKGROUND	However , emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches .
METHODS	We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression ( 535 patients ) , to the same combination for 72 weeks ( 18 cycles ; 541 patients ) , or to MPT for 72 weeks ( 547 patients ) .
METHODS	The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT .
RESULTS	The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone , 20.7 months with 18 cycles of lenalidomide-dexamethasone , and 21.2 months with MPT ( hazard ratio for the risk of progression or death , 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone ; P < 0.001 for both comparisons ) .
RESULTS	Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points , including overall survival ( at the interim analysis ) .
RESULTS	Overall survival at 4 years was 59 % with continuous lenalidomide-dexamethasone , 56 % with 18 cycles of lenalidomide-dexamethasone , and 51 % with MPT .
RESULTS	Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT ( 70 % vs. 78 % ) .
RESULTS	As compared with MPT , continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events , a moderate increase in infections , and fewer second primary hematologic cancers .
CONCLUSIONS	As compared with MPT , continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival , with an overall survival benefit at the interim analysis , among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation .
CONCLUSIONS	( Funded by Intergroupe , Francophone du Mylome and Celgene ; FIRST ClinicalTrials.gov number , NCT00689936 ; European Union Drug Regulating Authorities Clinical Trials number , 2007-004823-39 . )

###15644657
OBJECTIVE	The aim of this study was to analyze the prevalence of ventilator-associated pneumonia ( VAP ) using a closed-tracheal suction system vs. an open system .
METHODS	Prospective and randomized study , from October 1 , 2002 , to December 31 , 2003 .
METHODS	A 24-bed medical-surgical intensive care unit in a 650-bed tertiary hospital .
METHODS	Patients requiring mechanical ventilation for > 24 hrs .
METHODS	Patients were randomized into two groups ; one group was suctioned with the closed-tracheal suctioning system and another group with the open system .
METHODS	Throat swabs were taken at admission and twice a week until discharge to classify pneumonia in endogenous and exogenous .
RESULTS	A total of 443 patients ( 210 with closed-tracheal suction system and 233 with the open system ) were included .
RESULTS	There were no significant differences between groups of patients in age , sex , diagnosis groups , mortality , number of aspirations per day , and Acute Physiology and Chronic Health Evaluation II score .
RESULTS	No significant differences were found in either the percentage of patients who developed VAP ( 20.47 % vs. 18.02 % ) or in the number of VAP cases per 1000 mechanical ventilation-days ( 17.59 vs. 15.84 ) .
RESULTS	There were also no differences in the VAP incidence by mechanical ventilation duration .
RESULTS	At the same time , we did not find any differences in the incidence of exogenous VAP .
RESULTS	Likewise , there were also no differences in the microorganisms responsible for pneumonia .
RESULTS	Patient cost per day for the closed suction was more expensive than the open suction system ( 11.11 US dollars + / - 2.25 US dollars vs. 2.50 US dollars + / - 1.12 US dollars , p < .001 ) .
CONCLUSIONS	We conclude that in our study , the closed-tracheal suction system did not reduce VAP incidence , even for exogenous pneumonia .

###22116464
OBJECTIVE	To evaluate the pharmacokinetics ( PK ) of capecitabine and cisplatin , administered in combination with or without trastuzumab , in Japanese patients with HER2-positive advanced gastric cancer ( AGC ) .
METHODS	Patients eligible for this PK study ( study JP19959 ) , which was carried out during treatment Cycle 1 of the ToGA study , received either capecitabine and cisplatin ( XP arm ) or trastuzumab plus capecitabine and cisplatin ( HXP arm ) .
METHODS	All patients received capecitabine ( 1,000 mg/m ( 2 ) orally , twice daily for 14 days ) and cisplatin ( 80 mg/m ( 2 ) intravenous infusion on Day 1 ) .
METHODS	Patients in the HXP arm also received trastuzumab ( 8 mg/kg intravenous infusion on Day 1 ) , concurrently with capecitabine .
METHODS	No further study medication was administered during study JP19959 .
METHODS	Serial plasma samples for PK analysis were obtained at intervals before and after the administration of capecitabine and cisplatin on Day 1 .
RESULTS	Twenty-two patients were enrolled in this PK study : eight in the HXP arm and 14 in the XP arm .
RESULTS	All blood samples were available for PK analysis .
RESULTS	Co-administration of trastuzumab resulted in no statistically or clinically significant changes in the PK profiles of capecitabine or its metabolites , or of cisplatin ( total or unbound platinum ) .
CONCLUSIONS	Variability in the AUC ( last ) and C ( max ) values for the capecitabine was consistent with the known PK profile of capecitabine and fell within established limits .
CONCLUSIONS	Concurrent trastuzumab therapy is unlikely to alter the PK or safety profile of capecitabine or cisplatin in Japanese patients with HER2-positive AGC .

###15489585
BACKGROUND	Studies of viral hepatitis C have suggested that fibrosis can regress , at least in patients with sustained virological response .
BACKGROUND	A recent study suggested that cirrhosis was reversible in sustained and non-virological responders .
OBJECTIVE	To study fibrosis progression rate and cirrhosis reversion in patients treated for severe fibrosis with interferon or interferon + ribavirin .
METHODS	Ninety-nine patients were treated with interferon + ribavirin and 64 with interferon .
METHODS	The Metavir fibrosis score and the semiquantitative fibrosis score ( SFS ) were used to assess fibrosis .
RESULTS	In sustained responders , fibrosis progression rate decreased from 0.26 Metavir unit ( interquartile range : 0.19-0 .34 ) to -0.67 ( -0.67 to 0 ) ( P < 0.0001 ) and from 0.81 SFS unit ( 0.48-1 .13 ) to -1.33 ( -3.67 to 0 ) ( P < 0.0001 ) .
RESULTS	In non-responders , fibrosis progression rate decreased from 0.25 Metavir unit ( 0.17-0 .33 ) before treatment to 0 ( 0-0 ) during treatment ( P = 0.002 ) and from 0.63 SFS unit ( 0.49-1 .12 ) to 0 ( -2.67 -1.33 ) ( P = 0.18 ) .
RESULTS	Six out of 18 ( 33 % ) sustained virological responders and four of 43 ( 9 % ) non-responders regressed from cirrhosis ( F4 ) to severe fibrosis ( F3 ) ( P = 0.058 ) .
RESULTS	No patient with cirrhosis had a decrease of Metavir fibrosis score of 2 points .
CONCLUSIONS	Interferon can slow fibrosis progression in sustained virological responders with severe fibrosis .
CONCLUSIONS	In patients with a non-virological response and treated for 12 months the fibrosis progression rate was nil , meaning that only fibrosis stabilization could be obtained in these patients .
CONCLUSIONS	Then , longer treatment duration ( 3-4 years ) could be evaluated in non-virological responders .

###22682875
BACKGROUND	Coenzyme Q10 ( CoQ10 ) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits .
OBJECTIVE	We performed a randomized , double-blind , placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10 's effects on self-reported fatigue , depression , and quality of life ( QOL ) .
OBJECTIVE	Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo , each combined with 300 IU vitamin E , divided into 3 daily doses .
OBJECTIVE	Treatment was continued for 24 weeks .
OBJECTIVE	Blood tests , QOL measures , and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8 , 16 , and 24 weeks .
OBJECTIVE	Mixed-effects models were used to assess treatment differences in outcomes over time .
RESULTS	Between September 2004 and March 2009 , 236 women were enrolled .
RESULTS	Treatment arms were well balanced with respect to age ( range , 28-85 years ) , pathologic stage ( stage 0 , 91 % ; stage 1 , 8 % ; stage II , 1 % ) , ethnicity ( white , 87 % ; black , 11 % ; Hispanic , 2 % ) , and planned therapy .
RESULTS	Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL , respectively ; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL , respectively .
RESULTS	There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire ( least squares means , 7.08 vs 8.24 , P = .257 ) , the Functional Assessment of Chronic Illness Therapy-Fatigue tool ( 37.6 vs 37.6 , P = .965 ) , the Functional Assessment of Cancer Therapy-Breast Cancer instrument ( 111.9 vs 110.4 , P = .577 ) , or the Center for Epidemiologic Studies-Depression scale ( 11.6 vs 12.3 , P = .632 ) .
CONCLUSIONS	Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment .

###9233735
OBJECTIVE	To determine the therapeutic efficacy and safety of recombinant human interleukin-1 receptor antagonist ( rhIL-1ra ) in the treatment of patients with severe sepsis .
METHODS	Prospective , randomized , double-blind , placebo-controlled , multicenter trial with a planned , midstudy , interim analysis .
METHODS	Ninety-one academic medical center intensive care units in North America and Europe .
METHODS	Patients with severe sepsis or septic shock ( n = 696 ) received standard supportive care and antimicrobial therapy for sepsis , in addition to rhIL-1ra or placebo .
METHODS	Patients were randomized to receive either rhIL-1ra ( 100 mg ) or placebo ( vehicle ) by intravenous bolus , followed by a 72-hr continuous intravenous infusion of either rhIL-1ra ( 2.0 mg/kg/hr ) or placebo .
RESULTS	The study was terminated after an interim analysis found that it was unlikely that the primary efficacy end points would be met .
RESULTS	The 28-day , all-cause mortality rate was 33.1 % ( 116/350 ) in the rhIL-1ra treatment group , while the mortality rate in the placebo group was 36.4 % ( 126/346 ) , yielding a 9 % reduction in mortality rate ( p = .36 ) .
RESULTS	The patients were well matched at the time of study entry ; 52.9 % of placebo-treated patients were in shock while 50.9 % of rhIL-1ra-treated patients were in shock at the time of study entry ( p = .30 ) .
RESULTS	The mortality rate did not significantly differ between treatment groups when analyzed on the basis of site of infection , infecting microorganism , presence of bacteremia , shock , organ dysfunction , or predicted risk of mortality at the time of study entry .
RESULTS	No excess number of adverse reactions or microbial superinfections were attributable to rhIL-1ra treatment in this study .
CONCLUSIONS	A 72-hr , continuous intravenous infusion of rhIL-1ra failed to demonstrate a statistically significant reduction in mortality when compared with standard therapy in this multicenter clinical trial .
CONCLUSIONS	If rhIL-1ra treatment has any therapeutic activity in severe sepsis , the incremental benefits are small and will be difficult to demonstrate in a patient population as defined by this clinical trial .

###24494279
OBJECTIVE	To observe the clinical efficacy and safety of electroacupuncture ( EA ) combined with herbal acupoint sticking in the treatment of Bell 's palsy and provide optimizations for the clinic .
METHODS	One hundred and two cases of Bell 's palsy were randomized into an EA combined with herbal acupoint sticking group ( group A , 50 cases ) and an EA group ( group B , 52 cases ) , EA at Cuanzhu ( BL 2 ) , Yangbai ( GB 14 ) , Taiyang ( EX-HN 5 ) , Quanliao ( SI 18 ) , Xiaguan ( ST 7 ) , Yingxiang ( LI 20 ) , etc. were applied in both groups and `` facial paralys No.I '' was applied at Yifeng ( TE 17 ) in group A , once daily and 10 times totally were needed .
METHODS	The score of facial nerve function , clinical efficacy were compared before and after treatment .
METHODS	At 1 and 3 month follow up visit , the quality of life scale ( WHOQOL-BREF ) and the occurrence of complication were observed .
RESULTS	The scores of facial nerve function in group A and group B were all significantly improved compared with those before treatment ( 48.2 + / - 2.9 vs 25.7 + / - 4.9 , 45.9 + / - 6.2 vs 25.8 + / - 5.5 , both P < O. 01 ) , the cured rate in group A [ 82.0 % ( 41/50 ) ] were significantly superior to that in group B [ 67.3 % ( 35/52 ) ] ( P < 0.05 ) ; the difference of WHOQOL-BREF in both groups at 1 and 3 month follow up visit was not significant ( all P > 0.05 ) .
RESULTS	The occurrence of complication in group A ( 1 case ) was significantly less than that in group B ( 8 cases , P 0.05 ) .
CONCLUSIONS	Compared with EA , the combination of EA and acupoint sticking therapy for Bell 's palsy can not only improve the clinical efficacy and reduce the occurrence of complication but also reliable without any side effect .

###15380907
OBJECTIVE	Malnutrition is a risk factor for mortality and various morbidities in the elderly .
OBJECTIVE	A low-energy intake often prevails and therapeutic interventions include the administration of dietary supplements , sometimes rich in proteins .
OBJECTIVE	We have tested the hypothesis that a protein-rich supplement inhibits appetite and decreases voluntary food intake .
METHODS	Twelve mildly undernourished ( BMI 21.3 + / - 2.4 kg/m2 ) elderly ( 84 + / - 7.8 yr ) diseased persons were each studied under 3 conditions , in which they were given in random order at breakfast , and on consecutive days : either no supplement , a 250 kcal , 20 g protein supplement or a 250 kcal , 3.5 g protein supplement .
METHODS	Hunger , fullness , and desire to eat sensations were monitored half-hourly from before breakfast until lunch , and hourly from lunch until dinner .
METHODS	Food intake was assessed by weighing food before and after meals .
METHODS	Total energy and macronutrient intakes were calculated over 24 h.
RESULTS	Both supplements increased energy intake ( +185 kcal protein supplement , +176 kcal ) .
RESULTS	Protein supplementation induced a net 17 g increase in protein intake ( P < or = 0.0003 ) .
RESULTS	Neither supplement affected spontaneous food intake at lunch , dinner , or over the 24 h. Protein supplementation significantly depressed appetite in the breakfast to lunch period .
CONCLUSIONS	A 250 kcal , 20 g protein supplement depresses hunger without affecting food intake in elderly diseased mildly undernourished persons .

###15911729
BACKGROUND	A consistent relationship between metabolic syndrome ( MS ) and myocardial infarction ( MI ) has been demonstrated .
BACKGROUND	We evaluated the effect of bezafibrate retard , a fibric acid derivative , on the incidence of MI in patients with MS enrolled in the Bezafibrate Infarction Prevention ( BIP ) study .
METHODS	Patients who displayed at least 3 of the following 5 risk factors were considered to have MS : ( 1 ) a fasting glucose level of 110 mg/dL ( 6.11 mmol/L ) ; ( 2 ) a triglyceride level of 150 mg/dL ( 1.70 mmol/L ) ; ( 3 ) a high-density lipoprotein cholesterol level less than 40 mg/dL ( < 1.04 mmol/L ) in men or less than 50 mg/dL ( < 1.30 mmol/L ) in women ; ( 4 ) a systolic blood pressure of 130 mm Hg or diastolic blood pressure of 85 mm Hg ; and ( 5 ) a body mass index of 28.0 kg/m ( 2 ) .
METHODS	The study sample for this post hoc subgroup analyses comprised 1470 patients aged 42 to 74 years .
METHODS	The patients received either 400 mg of bezafibrate retard ( 740 patients ) or placebo ( 730 patients ) once a day .
METHODS	The mean follow-up period was 6.2 years for events and 8.1 years for mortality data .
RESULTS	New MI was recorded in 193 patients : 82 ( 11.1 % ) of the 740 patients in the bezafibrate group vs 111 ( 15.2 % ) of the 730 patients in the placebo group ( P = .02 ) .
RESULTS	Bezafibrate was associated with a reduced risk of any MI and nonfatal MI with hazard ratios ( HRs ) of 0.71 ( 95 % confidence interval [ CI ] , 0.54-0 .95 ) and 0.67 ( 95 % CI , 0.49-0 .91 ) , respectively .
RESULTS	The cardiac mortality risk tended to be lower in patients taking bezafibrate ( HR , 0.74 ; 95 % CI , 0.54-1 .03 ) .
RESULTS	In 575 patients with augmented features of MS ( 4-5 risk factors ) , the remarkable strengthening of cardiac mortality reduction when taking bezafibrate ( HR , 0.44 ; 95 % CI , 0.25-0 .80 ) should be noted .
CONCLUSIONS	Bezafibrate reduces the incidence of MI in patients with MS during long-term follow-up .

###23082002
OBJECTIVE	Vismodegib , a Hedgehog pathway inhibitor , has preclinical activity in colorectal cancer ( CRC ) models .
OBJECTIVE	This trial assessed the efficacy , safety , and pharmacokinetics of adding vismodegib to first-line treatment for metastatic CRC ( mCRC ) .
METHODS	Patients were randomized to receive vismodegib ( 150 mg/day orally ) or placebo , in combination with FOLFOX or FOLFIRI chemotherapy plus bevacizumab ( 5 mg/kg ) every 2 weeks until disease progression or intolerable toxicity .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
METHODS	Key secondary objectives included evaluation of predictive biomarkers and pharmacokinetic drug interactions .
RESULTS	A total of 199 patients with mCRC were treated on protocol ( 124 FOLFOX , 75 FOLFIRI ) .
RESULTS	The median PFS hazard ratio ( HR ) for vismodegib treatment compared with placebo was 1.25 ( 90 % CI : 0.89-1 .76 ; P = 0.28 ) .
RESULTS	The overall response rates for placebo-treated and vismodegib-treated patients were 51 % ( 90 % CI : 43-60 ) and 46 % ( 90 % CI : 37-55 ) , respectively .
RESULTS	No vismodegib-associated benefit was observed in combination with either FOLFOX or FOLFIRI .
RESULTS	Increased tumor tissue Hedgehog expression did not predict clinical benefit .
RESULTS	Grade 3 to 5 adverse events reported for more than 5 % of patients that occurred more frequently in the vismodegib-treated group were fatigue , nausea , asthenia , mucositis , peripheral sensory neuropathy , weight loss , decreased appetite , and dehydration .
RESULTS	Vismodegib did not alter the pharmacokinetics of FOLFOX , FOLFIRI , or bevacizumab .
CONCLUSIONS	Vismodegib does not add to the efficacy of standard therapy for mCRC .
CONCLUSIONS	Compared with placebo , treatment intensity was lower for all regimen components in vismodegib-treated patients , suggesting that combined toxicity may have contributed to lack of efficacy .

###19852293
OBJECTIVE	To explore the mechanism of Chinese medicinal therapy for nourishing blood and softening Gan in treating senile pruritus through observing the impact of Guishen Zhiyang Recipe ( GZR ) on serum levels of stem cell factor ( SCF ) and dynorphin ( DYN ) in patients suffered from the disease of blood-deficiency and Gan-hyperactive syndrome type ( BDGH ) .
METHODS	Sixty patients with senile pruritus were equally randomized into two groups , the patients in the treated group ( 33 cases ) were treated by GZR , and those in the control group ( 28 cases ) were treated by Fuyang Granule , all for 8 weeks .
METHODS	Changes of symptoms and skin lesions as well as blood levels of SCF and DYN were observed before and after treatment .
RESULTS	Three patients were rejected from the treated group .
RESULTS	Twenty patients in the treated group were cured after treatment , the cure rate being 66.7 % , which was significantly higher than that in the control group ( 10 patients , 35.7 % , P < 0.05 ) .
RESULTS	Levels of SCF and DYN in the treated group significantly lowered after treatment ( all P < 0.01 ) , and were lower than those in the control group ( P < 0.05 and P < 0.01 , respectively ) .
CONCLUSIONS	GZR shows favorite effect in treating senile pruritus of BDGH type and it may be achieved by regulating SCF and DYN levels to improve the pruritus associated inflammatory media .

###25724455
OBJECTIVE	Infliximab , a tumor necrosis factor antagonist , is effective for treating patients with Crohn 's disease ( CD ) and ulcerative colitis ( UC ) .
OBJECTIVE	We aimed to determine whether dosing based on therapeutic drug monitoring increases rate of remission and whether continued concentration-based dosing is superior to clinically based dosing of infliximab for maintaining remission in patients with CD and UC .
METHODS	We performed a 1-year randomized controlled trial at a tertiary referral center , including 263 adults ( 178 with CD and 85 with UC ) with stable responses to maintenance infliximab therapy .
METHODS	Doses were escalated or reduced using an algorithm to reach a target trough concentration ( TC ) of 3-7 g/mL in all patients ( optimization phase ) .
METHODS	Patients were randomly assigned ( 1:1 ) to groups that received infliximab dosing based on their clinical features ( n = 123 ) or continued dosing based on TCs ( n = 128 ) ( maintenance phase ) .
METHODS	The primary end point was clinical and biochemical remission at 1 year after the optimization phase .
RESULTS	At screening , 115 of 263 patients had a TC of infliximab of 3-7 g/mL ( 43.7 % ) .
RESULTS	Of 76 patients with TCs < 3 g/mL , 69 patients ( 91 % ) achieved TCs of 3-7 g/mL after dose escalation .
RESULTS	This resulted in a higher proportion of CD patients in remission than before dose escalation ( 88 % vs 65 % ; P = .020 ) and a decrease in the median concentration of C-reactive protein , compared with before the dose increase ( 3.2 vs 4.3 mg/L ; P < .001 ) ; these changes were not observed in patients with UC .
RESULTS	Of 72 patients with TCs > 7 g/mL , 67 patients ( 93 % ) achieved TCs of 3-7 g/mL after dose reduction .
RESULTS	This resulted in a 28 % reduction in drug cost from before dose reduction ( P < .001 ) .
RESULTS	Sixty-six percent of patients whose dosing was based on clinical features and 69 % whose dosing was based on TC achieved remission , the primary end point ( P = .686 ) .
RESULTS	Disease relapsed in 21 patients who received clinically based dosing ( 17 % ) and 9 patients who received concentration-based dosing ( 7 % ) ( P = .018 ) .
CONCLUSIONS	Targeting patients ' infliximab TCs to 3-7 g/mL results in a more efficient use of the drug .
CONCLUSIONS	After dose optimization , continued concentration-based dosing was not superior to clinically based dosing for achieving remission after 1 year , but was associated with fewer flares during the course of treatment .
CONCLUSIONS	ClinicalTrialsRegister.eu number : 2011-002061-38 .

###23887713
OBJECTIVE	Prostate cancer is the second most common cancer in men and the sixth most common cause of death from cancer in men worldwide .
OBJECTIVE	Currently , a sufficient pathological distinction between patients requiring further treatment and those for which active surveillance remains an option is still lacking , which leads to the problem of overtreatment .
OBJECTIVE	Cell proliferation is routinely assessed by detecting Ki-67 antigen .
OBJECTIVE	While Ki-67 is expressed throughout the interphase of proliferating cells , phosphorylation of the chromatin constituent histone H3 occurs only during the late G2 phase and mitosis thus providing a more strict assessment of the mitotic activity .
OBJECTIVE	We undertook this study to test whether expression of the recently introduced proliferation marker phospho-histone H3 ( pHH3 ) in prostate carcinoma tissue sections exhibits prognostic significance in comparison with Ki-67 .
METHODS	Protein expression of pHH3 and Ki-67 was assessed on TMA consisting of paraffin-embedded tissue from men that had undergone radical prostatectomy .
METHODS	The analysis included triplicate tissue cores of a total of 339 tumor foci .
METHODS	Immunohistochemical staining of pHH3 and Ki-67 was performed and analyzed using Definiens imaging software .
RESULTS	Prostate cancer tissue exhibited a significantly higher frequency of pHH3-positive cells compared to benign prostate tissue .
RESULTS	pHH3 expression was significantly correlated with Ki-67 expression .
RESULTS	Furthermore , statistical analysis revealed positive correlation between pHH3 expression and PSA levels at diagnosis and in addition negatively correlated with overall survival .
RESULTS	In contrast to Ki-67 staining , pHH3 expression did not correlate with Gleason grade .
CONCLUSIONS	Our data point to a conceivable role of pHH3 as prognostic biomarker in prostate carcinoma .

###19459475
OBJECTIVE	To confirm and prove on the extended contingent of volunteers the non-reactogenicity , safety and immunogenicity of `` Grifor '' vaccine in comparative trial with registered in Russia commercial vaccine `` Vaxigrip '' .
METHODS	Phase II clinical trial was performed on the research bases of Mechnikov Institute of Vaccines and Sera and Institute of Influenza .
METHODS	In single-blind comparative prospective randomized trial 300 adult volunteers ( 150 volunteers on each base ) aged 18 - 60 y.o. were divided on 3 equivalent groups .
METHODS	Assessment of antigenic characteristics of `` Grifor '' vaccine was performed using hemagglutination inhibition assay ( HAI ) with chicken erythrocytes measuring geometric mean titer ( GMT ) , seroconversion factor as well as level of seroconversion and seroprotection .
RESULTS	Previously performed studies proved non-reactogenicity , safety and high immunogenicity of `` Grifor '' , whereas this comparative trial performed with commercial vaccine `` Vaxigrip '' did not reveal significant advantage in any of studied vaccine .
CONCLUSIONS	`` Grifor '' vaccine meet the requirements of both EMEA CPMP and methodic guidelines MY 3.3.2.1758-03 for inactivated influenza vaccines , which allows to register vaccine `` Grifor '' in Russian Federation .

###25165427
BACKGROUND	Postoperative nausea and vomiting ( PONV ) is one of the most common postsurgical complications .
BACKGROUND	Palonosetron , a 5-hydroxytryptamine receptor antagonist , is effective for PONV prevention .
BACKGROUND	Herein , we compared palonosetron and aprepitant ( a neurokinin-1 receptor antagonist ) for PONV prevention in patients indicated for laparoscopic gynaecologic surgery .
METHODS	Ninety-three patients who were scheduled to undergo laparoscopic gynaecologic surgery under general anaesthesia were assigned to receive either a single intravenous injection of 0.075-mg palonosetron or 40-mg oral aprepitant in a double-blind randomised trial .
METHODS	The primary efficacy end points included complete response ( visual analogue scale [ VAS ] nausea score < 4 and no use of rescue therapy ) 0-48 h after surgery .
METHODS	Nausea severity ( 0-10 ) and use of rescue therapy were monitored for 0-48 h.
METHODS	The secondary efficacy end points were the effect of aprepitant quantified using a 10-point VAS for pain , consumption of intravenous patient-controlled analgesia , and use of rescue analgesics .
RESULTS	Aprepitant was non-inferior to palonosetron in terms of complete response 0-48 hours after surgery ( 74 % vs. 77 % ) .
RESULTS	At 0 and 2 h after administration , the nausea severity with 40-mg aprepitant was significantly lesser than that with 0.075-mg palonosetron ( P < 0.05 ) .
RESULTS	At 6 and 24 h after administration , fentanyl consumption with 40-mg aprepitant was significantly lower than that with 0.075-mg palonosetron .
RESULTS	Greater amounts of rescue analgesics were required in the aprepitant group .
CONCLUSIONS	Palonosetron and aprepitant were both effective for PONV prevention in the patients indicated for laparoscopic gynaecologic surgery .
CONCLUSIONS	The drugs can be used in combination for multimodal therapy because they bind to different receptors .
CONCLUSIONS	More research is needed to evaluate the effects of aprepitant on pain management in humans .

###11974545
BACKGROUND	A two-armed , prospective , randomized study was performed to evaluate the influence of primary velopharyngoplasty on speech and facial growth in patients with cleft lip and palate .
METHODS	Forty-two patients born between 1978 and 1982 were included .
METHODS	All patients were treated with an intravelar veloplasty , and 21 patients simultaneously with a velopharyngoplasty according to Sanvenero-Rosselli .
METHODS	The patients were examined at the age of 5 , 10 , 15 , and 18 years according to the recommendations of the research group of the German Association of Craniomaxillofacial Surgery for minimal documentation .
RESULTS	Patients treated with primary velopharyngoplasty showed a higher deficit in transversal growth of the maxilla of 0.6 mm in the molar region in adolescence in comparison to the control group .
RESULTS	The sagittal growth of the maxilla was reduced at 2.6 degrees in the SNA angle .
RESULTS	A statistically significant decrease in growth of the maxilla caused by primary velopharyngoplasty was not detectable ( p > 0.05 ) .
RESULTS	The incidence of rhinophonia and dyslalia did not differ significantly .
RESULTS	Primary velopharyngoplasty did not lead to speech improvement either in childhood or in adolescence .
CONCLUSIONS	With regard to a potential decrease in growth of the maxilla and the disadvantages of a hindered nasal respiration , a primary velopharyngoplasty therefore does not seem to be indicated .

###11966786
BACKGROUND	There are several types of dressings which may be utilized after facial laser resurfacing .
BACKGROUND	Laser surgeons favoring the open type of dressing have used the Aquaphor original formula to reduce the loss of moisture from laser resurfaced skin .
BACKGROUND	The objective of this study was to compare the effectiveness of a mucopolysaccharide-cartilage complex ( MCC ) containing healing ointment with the standard therapy of Aquaphor ointment in treating erythema , edema , and skin erosion caused by Er : YAG laser resurfacing of facial skin .
OBJECTIVE	To compare healing time after Er : YAG laser resurfacing treated side-by-side with MCC as compared with Aquaphor .
METHODS	Nineteen patients completing Er : YAG laser resurfacing were randomly assigned to receive MCC healing ointment on one side of their face and standard therapy with Aquaphor on the other for eight consecutive treatment days .
METHODS	Immediately after surgery and again on days 1 , 2 , 3 , 4 , 7 , and 8 , the severity of erythema , edema , and erosion was scored on a 0-3 scale ( 0 = no observable effect , 1 = mild , 2 = moderate , 3 = severe ) .
METHODS	Photographs were taken at each follow-up visit .
METHODS	Following scoring on study day 0 , the day of resurfacing , treatment was applied according to the left or right assignment code of the randomization schedule .
RESULTS	Mean severity ratings for all variables ( erythema , edema , and erosion ) were consistently lower for MCC healing ointment as compared to Aquaphor ointment .
RESULTS	Based on the calculated overall efficacy index , MCC ointment was statistically superior to Aquaphor for all three variables : erythema , P < .001 ; edema , P = .017 ; erosion , P < .001 .
CONCLUSIONS	The results of our study demonstrate that MCC healing ointment may provide an advantage over the standard therapy of Aquaphor ointment in the treatment of edema , erosion , and erythema caused by laser resurfacing of facial skin .
CONCLUSIONS	Mean daily severity scores were consistently lower and improvement tended to occur earlier with MCC healing ointment .

###24557989
BACKGROUND	Whether convective therapies allow better control of serum phosphate ( P ) is still undefined , and no data are available concerning on-line haemofiltration ( HF ) .
BACKGROUND	The objectives of the study are to evaluate the effect of convective treatments ( CTs ) on P levels in comparison with low-flux haemodialysis ( HD ) and to evaluate the correlates of serum phosphate in a post hoc analysis of a randomized clinical trial .
METHODS	This analysis was performed in the database of a multicentre , open label and randomized controlled study in which 146 chronic HD patients from 27 Italian centres were randomly assigned to HD ( 70 patients ) or CTs : on-line pre-dilution HF ( 36 patients ) or on-line pre-dilution haemodiafiltration ( 40 patients ) .
RESULTS	CTs did not affect P ( P = 0.526 ) , calcium ( Ca ) ( P = 0.849 ) and parathyroid hormone levels ( P = 0.622 ) .
RESULTS	P levels were associated with the use of phosphate binders including aluminium-based phosphate binders ( P < 0.001 ) and sevelamer ( P < 0.001 ) , pre-dialysis bicarbonate levels ( P < 0.001 ) and pre-dialysis blood K levels ( P < 0.001 ) .
RESULTS	On multivariate analysis ( generalized linear model ) , serum P was again largely unassociated with CTs ( P = 0.631 ) .
RESULTS	Notably , participating centres were by far the strongest independent correlate of serum P , explaining 45.3 % of the variance of serum P over the trial and this association was confirmed at multivariate analysis .
RESULTS	Bicarbonate ( P < 0.001 ) and , to a weaker extent , serum K ( P = 0.032 ) were independently related to serum P.
CONCLUSIONS	In comparison with low-flux HD , CTs did not significantly affect serum P levels .
CONCLUSIONS	Participating centres were the main source of P variability during the trial followed by treatment with phosphate binders , serum bicarbonate and , to a weak extent , serum potassium levels ( ClinicalTrials.gov Identifier : NCT011583309 ) .

###22782199
BACKGROUND	Growing antibiotic resistance warrants studying nonantibiotic prophylaxis for recurrent urinary tract infections ( UTIs ) .
BACKGROUND	Use of lactobacilli appears to be promising .
METHODS	Between January 2005 and August 2007 , we randomized 252 postmenopausal women with recurrent UTIs taking part in a double-blind noninferiority trial to receive 12 months of prophylaxis with trimethoprim-sulfamethoxazole , 480 mg , once daily or oral capsules containing 109 colony-forming units of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 twice daily .
METHODS	Primary end points were the mean number of symptomatic UTIs , proportion of participants with at least 1 UTI during 12 months , time to first UTI , and development of antibiotic resistance by Escherichia coli .
RESULTS	The mean number of symptomatic UTIs in the year preceding randomization was 7.0 in the trimethoprim-sulfamethoxazole group and 6.8 in the lactobacilli group .
RESULTS	In the intention-to-treat analysis , after 12 months of prophylaxis , these numbers were 2.9 and 3.3 , respectively .
RESULTS	The between-treatment difference of 0.4 UTIs per year ( 95 % CI , -0.4 to 1.5 ) was outside our noninferiority margin .
RESULTS	At least 1 symptomatic UTI occurred in 69.3 % and 79.1 % of the trimethoprim-sulfamethoxazole and lactobacilli participants , respectively ; median times to the first UTI were 6 and 3 months , respectively .
RESULTS	After 1 month of trimethoprim-sulfamethoxazole prophylaxis , resistance to trimethoprim-sulfamethoxazole , trimethoprim , and amoxicillin had increased from approximately 20 % to 40 % to approximately 80 % to 95 % in E coli from the feces and urine of asymptomatic women and among E coli causing a UTI .
RESULTS	During the 3 months after trimethoprim-sulfamethoxazole discontinuation , resistance levels gradually decreased .
RESULTS	Resistance did not increase during lactobacilli prophylaxis .
CONCLUSIONS	In postmenopausal women with recurrent UTIs , L rhamnosus GR-1 and L reuteri RC-14 do not meet the noninferiority criteria in the prevention of UTIs when compared with trimethoprim-sulfamethoxazole .
CONCLUSIONS	However , unlike trimethoprim-sulfamethoxazole , lactobacilli do not increase antibiotic resistance .
CONCLUSIONS	TRIAL REGISTRATION isrctn.org Identifier : ISRCTN50717094 .

###24768811
OBJECTIVE	Patients with cirrhosis have reduced exercise tolerance , measured objectively as decreased peak exercise oxygen uptake ( peak VO2 ) .
OBJECTIVE	Reduced peak VO2 is associated with decreased survival time .
OBJECTIVE	The effect of aerobic exercise training on peak VO2 has not been well studied in patients with cirrhosis .
OBJECTIVE	We evaluated the safety and efficacy of 8 weeks of supervised exercise on peak VO2 , quadriceps muscle thickness , and quality of life .
METHODS	In a prospective pilot study , stable patients ( 79 % male , 57.6 6.7 years old ) with Child-Pugh class A or B cirrhosis ( mean Model for End-Stage Liver Disease score , 10 2.2 ) were randomly assigned to groups that received exercise training ( n = 9 ) or usual care ( controls , n = 10 ) at the University of Alberta Hospital in Canada from February through June 2013 .
METHODS	Supervised exercise was performed on a cycle ergometer 3 days/week for 8 weeks at 60 % -80 % of baseline peak VO2 .
METHODS	Peak VO2 , quadriceps muscle thickness ( measured by ultrasound ) , thigh circumference , answers from Chronic Liver Disease Questionnaires , EQ-visual analogue scales , 6-minute walk distance , and Model for End-Stage Liver Disease scores were evaluated at baseline and at week 8 .
METHODS	Analysis of covariance was used to compare variables .
RESULTS	At week 8 , peak VO2 was 5.3 mL/kg/min higher in the exercise group compared with controls ( 95 % confidence interval , 2.9-7 .8 ; P = .001 ) .
RESULTS	Thigh circumference ( P = .001 ) , thigh muscle thickness ( P = .01 ) , and EQ-visual analogue scale determined self-perceived health status ( P = .01 ) was also significantly higher in the exercise group compared with controls at week 8 ; fatigue subscores of the Chronic Liver Disease Questionnaires were lower in the exercise group compared with controls ( P = .01 ) .
RESULTS	No adverse events occurred during cardiopulmonary exercise testing or training .
CONCLUSIONS	In a controlled prospective pilot trial , 8 weeks of supervised aerobic exercise training increased peak VO2 and muscle mass and reduced fatigue in patients with cirrhosis .
CONCLUSIONS	No relevant adverse effects were observed .
CONCLUSIONS	Larger trials are needed to evaluate the effects of exercise in patients with cirrhosis .
CONCLUSIONS	ClinicalTrials.gov number : NCT01799785 .

###8135325
BACKGROUND	Following animal experiments where correlations were observed between serum magnesium level and noise-induced permanent hearing threshold shifts ( NIPTS ) , we tested the prophylactic effect of magnesium in human subjects exposed to hazardous noise .
METHODS	Subjects were 300 young , healthy , and normal-hearing recruits who underwent 2 months of basic military training .
METHODS	This training necessarily included repeated exposures to high levels of impulse noises while using ear plugs .
METHODS	During this placebo-controlled , double-blind study , each subject received daily an additional drink containing either 6.7 mmol ( 167 mg ) magnesium aspartate or a similar quantity of placebo ( Na-aspartate ) .
RESULTS	NIPTS was significantly more frequent and more severe in the placebo group than in the magnesium group , especially in bilateral damages .
RESULTS	NIPTS was negatively correlated to the magnesium content of blood red cells but especially to the magnesium mononuclear cells .
RESULTS	Long-term additional intake of a small dose of oral magnesium was not accompanied by any notable side effect .
CONCLUSIONS	This study may introduce a significant natural agent for the reduction of hearing damages in noise-exposed population .

###12545147
BACKGROUND	Teriparatide ( recombinant human parathyroid hormone [ 1-34 ] ) stimulates bone formation and causes small transient increases in serum calcium concentration .
BACKGROUND	We assessed whether teriparatide causes a change in digoxin pharmacodynamic effects by measuring systolic time intervals and heart rate .
METHODS	Measurements were made by echocardiographic Doppler that examined 3 systolic time intervals , as follows : QS ( 2 ) ( time from Q wave on electrocardiogram to the closure of the aortic valve ) , left ventricular ejection time , and pre-ejection period , all corrected for changes in heart rate .
METHODS	Fifteen healthy subjects ( 2 men and 13 women ) were administered a single subcutaneous teriparatide dose ( 20 microg ) on day 1 and then equilibrated on a daily oral dose of digoxin for 15 days .
METHODS	Subcutaneous placebo and teriparatide , 20 microg , were given in a randomized crossover design with the 14th ( day 15 ) and 15th ( day 16 ) digoxin doses .
METHODS	Serial systolic time interval and heart rate measurements were obtained on days 1 , 15 , and 16 .
RESULTS	After subjects were dosed to steady state with digoxin , there were statistically significant reductions in QS ( 2 ) corrected for heart rate ( QS ( 2 ) c ) of 23 to 25 ms and heart rate of 4 to 6 beats/min .
RESULTS	However , there was no difference between treatment with digoxin plus placebo versus digoxin plus teriparatide .
RESULTS	The study was powered to find a difference in QS ( 2 ) c as small as 6 ms ( alpha = .05 , beta = .2 ) .
CONCLUSIONS	Teriparatide , 20 microg subcutaneously , does not alter the cardiac effect of digoxin .

###21122269
OBJECTIVE	In fibromyalgia syndrome ( FMS ) defined rehabilitation guidelines are yet to be validated .
OBJECTIVE	Our aim is to evaluate the efficacy of the Ressguier method ( RM ) in FMS .
METHODS	Forty-one patients were randomly assigned to Interventional ( 22 pts ) and Observational ( 19 pts ) Group ( IG and OG ) .
METHODS	The study lasted 8 months .
METHODS	Patients were assessed at baseline ( T0 ) after a 2-month rehabilitation ( T1 ) and at a 6-month follow-up ( T2 ) ( only IG ) with SF-36 Physical ( PSI ) and Mental Synthetic Index ( MSI ) , Regional Pain Scale ( RPS ) , Fibromyalgia Impact Questionnaire ( FIQ ) , Number Rating Scales 0-10 to measure pain , movement quality , sleep , relax ability , analgesics number/per week .
METHODS	OG patients maintained their lifestyle for the duration of the study .
METHODS	RM aims to obtain patient awareness and control of bodily perceptions , thus reaching a modulation of responses to pain .
METHODS	Therapist controls patient attention and perception by verbal and manual contacts and leads them to perform bodily and respiratory active and conscious movements .
RESULTS	In IG , at T1 all items were improved : PSI and MSI ( p < 0.001 and = 0.001 ) , FIQ ( p < 0.0001 ) , RPS ( p < 0.001 ) , pain ( p < 0.0001 ) , movement quality ( p = 0.001 ) , relax ability ( p < 0.0001 ) , sleep ( p < 0.001 ) ; analgesics number/per week was reduced ( p < 0.001 ) .
RESULTS	All results obtained at T1 , except FIQ , were maintained at T2 .
RESULTS	In OG at T1 versus T0 , no difference in any of the assessed parameters was observed .
CONCLUSIONS	In FMS patients , the rehabilitation with RM improves HRQoL , FMS-related disability and perceived pain , thus reducing the assumption of analgesics .

###16430782
BACKGROUND	Nursing home residents are frequently sent to hospital for diagnostic tests or to receive acute health care services .
BACKGROUND	These transfers are both costly and for some , associated with increased risks .
BACKGROUND	Although improved technology allows long-term care facilities to deliver more complex health care on site , if this is to become a trend then residents and family members must see the value of such care .
BACKGROUND	This qualitative study examined resident and family member perspectives on in situ care for pneumonia .
METHODS	A qualitative descriptive study design was used .
METHODS	Participants were residents and family members of residents treated for pneumonia drawn from a larger randomized controlled trial of a clinical pathway to manage nursing home-acquired pneumonia on-site .
METHODS	A total of 14 in-depth interviews were conducted .
METHODS	Interview data were analyzed using the editing style , described by Miller and Crabtree , to identify key themes .
RESULTS	Both residents and family members preferred that pneumonia be treated in the nursing home , where possible .
RESULTS	They both felt that caring and attention are key aspects of care which are more easily accessible in the nursing home setting .
RESULTS	However , residents felt that staff or doctors should make the decision whether to hospitalize them , whereas family members wanted to be consulted or involved in the decision-making process .
CONCLUSIONS	These findings suggest that interventions to reduce hospitalization of nursing home residents with pneumonia are consistent with resident and family member preferences .

###18460033
OBJECTIVE	To investigate the interaction between ketoconazole and darunavir ( alone and in combination with low-dose ritonavir ) , in HIV-healthy volunteers .
METHODS	Volunteers received darunavir 400 mg bid and darunavir 400 mg bid plus ketoconazole 200 mg bid , in two sessions ( Panel 1 ) , or darunavir/ritonavir 400/100 mg bid , ketoconazole 200 mg bid and darunavir/ritonavir 400/100 mg bid plus ketoconazole 200 mg bid , over three sessions ( Panel 2 ) .
METHODS	Treatments were administered with food for 6 days .
METHODS	Steady-state pharmacokinetics following the morning dose on day 7 were compared between treatments .
METHODS	Short-term safety and tolerability were assessed .
RESULTS	Based on least square means ratios ( 90 % confidence intervals ) , during darunavir and ketoconazole co-administration , darunavir area under the curve ( AUC ( 12h ) ) , maximum plasma concentration ( C ( max ) ) and minimum plasma concentration ( C ( min ) ) increased by 155 % ( 80 , 261 ) , 78 % ( 28 , 147 ) and 179 % ( 58 , 393 ) , respectively , compared with treatment with darunavir alone .
RESULTS	Darunavir AUC ( 12h ) , C ( max ) and C ( min ) increased by 42 % ( 23 , 65 ) , 21 % ( 4 , 40 ) and 73 % ( 39 , 114 ) , respectively , during darunavir/ritonavir and ketoconazole co-administration , relative to darunavir/ritonavir treatment .
RESULTS	Ketoconazole pharmacokinetics was unchanged by co-administration with darunavir alone .
RESULTS	Ketoconazole AUC ( 12h ) , C ( max ) and C ( min ) increased by 212 % ( 165 , 268 ) , 111 % ( 81 , 144 ) and 868 % ( 544 , 1355 ) , respectively , during co-administration with darunavir/ritonavir compared with ketoconazole alone .
CONCLUSIONS	The increase in darunavir exposure by ketoconazole was lower than that observed previously with ritonavir .
CONCLUSIONS	A maximum ketoconazole dose of 200 mg day ( -1 ) is recommended if used concomitantly with darunavir/ritonavir , with no dose adjustments for darunavir/ritonavir .

###21730779
BACKGROUND	The risk of fistula formation is a major concern after incision and drainage of an anorectal abscess .
OBJECTIVE	Our objective was to the test the effects of antibiotic treatment on fistula formation after incision and drainage of anorectal abscesses .
METHODS	Randomized , placebo-controlled , double-blind study .
METHODS	Multicenter trial at 3 teaching hospitals in Turkey .
METHODS	Patients who underwent abscess drainage between September 2005 and January 2008 were evaluated for eligibility .
METHODS	Exclusion criteria included penicillin allergy , antimicrobial agent usage before enrolment , other infection , previous anorectal surgery , inflammatory bowel disease , suspicion of Fournier gangrene , secondary and recurrent anorectal abscesses , anal fistula at time of the surgery , immune compromised states , and pregnancy .
METHODS	Patients were randomly assigned to receive placebo or amoxicillin-clavulanic acid combination treatment for 10 days after abscess drainage .
METHODS	The primary end point was rate of anorectal fistula formation at 1-year follow-up .
RESULTS	: Of 334 patients assessed for eligibility , 183 entered the study ( placebo , 92 ; antibiotics , 91 ) .
RESULTS	Data were available for per-protocol analysis from 151 patients ( placebo , 76 ; antibiotics , 75 ) with a mean age of 37.6 years ; 118 patients ( 78.1 % ) were men .
RESULTS	Overall , 45 patients ( 29.8 % ) developed anal fistulas during 1-year follow-up .
RESULTS	Fistula formation occurred in 17 patients ( 22.4 % ) in the placebo group and in 28 patients ( 37.3 % ) in the antibiotic group ( P = .044 ) .
RESULTS	Risk of fistula formation was increased in patients with ischiorectal abscess ( odds ratio , 7.82 ) or intersphincteric abscess ( odds ratio , 3.35 ) compared with perianal abscess .
CONCLUSIONS	Antibiotic treatment following the drainage of an anorectal abscess has no protective effect regarding risk of fistula formation .

###15235928
BACKGROUND	A previous double-blind 24-week clinical trial of mizoribine ( MZ ) vs placebo in steroid-resistant primary nephrotic syndrome ( SRPNS ) showed that MZ was more effective than placebo in reducing the rate of deterioration of renal function .
BACKGROUND	The present study was conducted to evaluate the efficacy and safety of MZ in patients with SRPNS after 2 years ' treatment .
METHODS	A multicenter randomized open-label controlled trial in patients with SRPNS was conducted as a 2-year prospective postmarketing study .
RESULTS	There was a significant imbalance in the baseline serum albumin level ( s-Alb ) between the conventional therapy ( CT ) and MZ onlay therapy groups .
RESULTS	Early dropouts were more frequent in the subset of patients in the CT group having a baseline s-Alb < or = 3 g/dl .
RESULTS	Therefore , the primary analysis ( urinary protein level ( UP ) - improving effect ) was performed using a mixed-effects model , with stratification according to the baseline s-Alb value .
RESULTS	The analysis revealed that , in the subset of 34 patients with membranous nephropathy ( MN ) within the stratum of patients with baseline s-Alb < or = 3 g/dl ( n = 52 ) , the rate of change ( slope of change in the UP level/month ) , in terms of the log ( UP +0.2 ) , was -0.0577 in those allocated to the MZ group and -0.0227 in those allocated to the CT group ( P = 0.058 ) .
RESULTS	In the stratum of patients with a baseline s-Alb > 3 g/dl ( n = 97 ) , there were no significant differences in the UP between the two treatment groups .
RESULTS	Hence , MZ onlay therapy was not considered to be efficacious in this group of patients .
RESULTS	No serious adverse reactions to the drug were observed .
CONCLUSIONS	The present study yielded significant results , in that it suggested the possibility that long-term MZ therapy may afford further reduction of the UP , in addition to that obtained following CT , in particular , in MN patients in a severe nephrotic state .

###25411294
BACKGROUND	Prenatal calcium and iron supplements are recommended in settings of low dietary calcium intake and high prevalence of anemia .
BACKGROUND	However , calcium administration may inhibit iron absorption .
BACKGROUND	To overcome calcium-iron interactions , we developed a multi-micronutrient powder containing iron ( 60 mg ) , folic acid ( 400 g ) , and calcium carbonate granules microencapsulated with a pH-sensitive enteric coating to delay intestinal release .
OBJECTIVE	We aimed to establish in vivo evidence that enteric-coated ( EC ) calcium is bioavailable in pregnant women and to explore the dose-responsiveness of fractional calcium absorption ( FCA ) in pregnancy .
METHODS	This was a randomized crossover trial in pregnant women ( 26-28 wk of gestation ) in Dhaka , Bangladesh .
METHODS	Participants were allocated to 1 of 3 dose groups ( 500 , 1000 , or 1500 mg elemental Ca ) .
METHODS	FCA was estimated in random order for EC and non-EC ( control ) granules by a dual-stable-isotope method ( ( 44 ) Ca-labeled granules and intravenous ( 42 ) Ca ) on the basis of the relative recovery of ( 44 ) Ca compared with ( 42 ) Ca in urine over 48 h.
RESULTS	Forty-nine participants with FCA for both EC and non-EC granules were included in the primary analyses .
RESULTS	FCA geometric means were as follows : 21.8 % ( 500 mg ) , 9.2 % ( 1000 mg ) , and 11.7 % ( 1500 mg ) for non-EC granules compared with 3.3 % ( 500 mg ) , 1.2 % ( 1000 mg ) , and 2.1 % for EC granules .
RESULTS	Cumulative 48-h FCA of EC calcium was 85 % lower ( P < 0.001 ) than that of non-EC calcium , after adjustment for dose .
RESULTS	In comparison to 500 mg , the FCA for the 1000-mg dose was 61 % lower ( P < 0.001 ) and was 42 % lower ( P = 0.002 ) for the 1500-mg dose , after adjustment for formulation .
CONCLUSIONS	A pH-sensitive enteric coating substantially reduced calcium absorption from a prenatal multi-micronutrient powder .
CONCLUSIONS	In its current formulation , this novel supplement is not suitable for clinical use .
CONCLUSIONS	FCA was highly dose-dependent , such that doses of 1000 and 1500 mg delivered only negligibly more bioavailable calcium than the 500-mg dose .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01678079 .

###23826843
OBJECTIVE	To compare micropercutaneous nephrolithotomy ( microperc ) and retrograde intrarenal surgery ( RIRS ) for the management of renal calculi < 1.5 cm with regard to stone clearance rates and surgical characteristics , complications and postoperative recovery .
METHODS	Seventy patients presenting with renal calculi < 1.5 cm were equally randomized to a microperc or a RIRS group between February 2011 and August 2012 in this randomized controlled trial .
METHODS	Randomization was based on centralized computer-generated numbers .
METHODS	Patients and authors assessing the outcomes were not blinded to the procedure .
METHODS	Microperc was performed using a 4.85-F ( 16-gauge ) needle with a 272-m laser fibre .
METHODS	RIRS was performed using a uretero-renoscope .
METHODS	Variables studied were stone clearance rates , operating time , need for JJ stenting , intra-operative and postoperative complications ( according to the Clavien-Dindo classification system ) , surgeon discomfort score , postoperative pain score , analgesic requirement and hospital stay .
METHODS	Stone clearance was assessed using ultrasonography and X-ray plain abdominal film of kidney , ureter and bladder at 3 months .
RESULTS	There were 35 patients in each group .
RESULTS	All the patients were included in the final analysis .
RESULTS	The stone clearance rates in the microperc and RIRS groups were similar ( 97.1 vs 94.1 % , P = 1.0 ) .
RESULTS	The mean [ sd ] operating time was similar between the groups ( 51.6 [ 18.5 ] vs 47.1 [ 17.5 ] , P = 0.295 ) .
RESULTS	JJ stenting was required in a lower proportion of patients in the microperc group ( 20 vs 62.8 % , P < 0.001 ) .
RESULTS	Intra-operative complications were a minor pelvic perforation in one patient and transient haematuria in two patients , all in the microperc group .
RESULTS	One patient in each group required conversion to miniperc .
RESULTS	One patient in the microperc group needed RIRS for small residual calculi 1 day after surgery .
RESULTS	The decrease in haemoglobin was greater in the microperc group ( 0.96 vs 0.56 g/dL , P < 0.001 ) .
RESULTS	The incidence of postoperative fever ( Clavien I ) was similar in the two groups ( 8.6 vs 11.4 % , P = 1.0 ) .
RESULTS	None of the patients in the study required blood transfusion .
RESULTS	The mean [ sd ] postoperative pain score at 24h was slightly higher in the microperc group ( 1.9 [ 1.2 ] vs 1.6 [ 0.8 ] , P = 0.045 ) .
RESULTS	The mean [ sd ] analgesic requirement was higher in the microperc group ( 90 [ 72 ] vs 40 [ 41 ] mg tramadol , P < 0.001 ) .
RESULTS	The mean [ sd ] hospital stay was similar in the two groups ( 57 [ 22 ] vs 48 [ 18 ] h , P = 0.08 ) .
CONCLUSIONS	Microperc is a safe and effective alternative to RIRS for the management of small renal calculi and has similar stone clearance and complication rates when compared to RIRS .
CONCLUSIONS	Microperc is associated with higher haemoglobin loss , increased pain and higher analgesic requirements , while RIRS is associated with a higher requirement for JJ stenting .

###23457678
BACKGROUND	Menthol ( l-menthol ) is a naturally-occurring cold receptor agonist commonly used to provide symptomatic relief for upper airway congestion .
BACKGROUND	Menthol can also reduce the sensation of dyspnea .
BACKGROUND	It is unclear whether the physiological action of menthol in dyspnea reduction is through its cold receptor agonist effect or whether associated mechanical changes occur in the upper airway .
OBJECTIVE	To determine whether menthol inhalation alters upper airway resistance in humans .
METHODS	A randomized , sham-controlled , single-blinded crossover study of inhaled menthol on upper airway resistance during semirecumbent quiet breathing in healthy subjects was conducted .
METHODS	Ten healthy participants ( eight female ) with a mean ( SD ) age of 211.6 years completed the study .
RESULTS	Nasal resistance before testing was similar on both occasions .
RESULTS	No differences were found in respiratory frequency ( mean SEM ) ( menthol 17.01.1 cmH2OLs ; sham 16.90.9 cmH2OLs ) , minute ventilation ( menthol 7.70.5 cmH2OLs ; sham 7.90.5 cmH2OLs ) or total inspiratory timetotal breath time ( menthol 0.40.1 cmH2OLs ; sham 0.40.1 cmH2OLs ) .
RESULTS	The upper airway resistance was similar during menthol ( 3.470.32 cmH2OLs ) and sham ( 3.270.28 cmH2OLs ) ( P = 0.33 ) inhalation .
CONCLUSIONS	Inhalation of menthol does not alter upper airway resistance in awake human subjects .

###22459773
BACKGROUND	While the burden of chronic cough in children has been documented , etiologic factors across multiple settings and age have not been described .
BACKGROUND	In children with chronic cough , we aimed ( 1 ) to evaluate the burden and etiologies using a standard management pathway in various settings , and ( 2 ) to determine the influence of age and setting on disease burden and etiologies and etiology on disease burden .
BACKGROUND	We hypothesized that the etiology , but not the burden , of chronic cough in children is dependent on the clinical setting and age .
METHODS	From five major hospitals and three rural-remote clinics , 346 children ( mean age 4.5 years ) newly referred with chronic cough ( > 4 weeks ) were prospectively managed in accordance with an evidence-based cough algorithm .
METHODS	We used a priori definitions , timeframes , and validated outcome measures ( parent-proxy cough-specific quality of life [ PC-QOL ] , a generic QOL [ pediatric quality of life ( PedsQL ) ] , and cough diary ) .
RESULTS	The burden of chronic cough ( PC-QOL , cough duration ) significantly differed between settings ( P = .014 , 0.021 , respectively ) , but was not influenced by age or etiology .
RESULTS	PC-QOL and PedsQL did not correlate with age .
RESULTS	The frequency of etiologies was significantly different in dissimilar settings ( P = .0001 ) ; 17.6 % of children had a serious underlying diagnosis ( bronchiectasis , aspiration , cystic fibrosis ) .
RESULTS	Except for protracted bacterial bronchitis , the frequency of other common diagnoses ( asthma , bronchiectasis , resolved without specific-diagnosis ) was similar across age categories .
CONCLUSIONS	The high burden of cough is independent of childrens age and etiology but dependent on clinical setting .
CONCLUSIONS	Irrespective of setting and age , children with chronic cough should be carefully evaluated and child-specific evidence-based algorithms used .

###17139034
BACKGROUND	There is equivocal evidence of the effectiveness of adherence therapy in improving treatment adherence and clinical outcomes for people with schizophrenia .
OBJECTIVE	To evaluate the effectiveness of adherence therapy in improving quality of life for people with schizophrenia .
METHODS	A 52-week , single-blind , multicentre randomised controlled trial of the effectiveness of adherence therapy .
METHODS	Participants were individually randomised to receive eight sessions of adherence therapy or health education .
METHODS	Assessments were undertaken at baseline and at 52-week follow-up .
RESULTS	Adherence therapy was no more effective than health education in improving quality of life .
CONCLUSIONS	This effectiveness trial provides evidence for the lack of effect of adherence therapy in people with schizophrenia with recent clinical instability , treated in ordinary clinical settings .

###20581776
BACKGROUND	Postoperative nausea and vomiting ( PONV ) are some of the most-common and undesirable adverse effects after surgery performed under general anesthesia .
BACKGROUND	We investigated the prophylactic value of dexamethasone as an alternate to ondansetron or metoclopramide to prevent PONV after gynecologic surgery .
METHODS	One hundred sixty ASA I-II patients scheduled for elective gynecologic surgery were enrolled .
METHODS	Before induction of anesthesia , patients were randomly allocated to receive intravenously dexamethasone ( 8 mg ) in group D , ondansetron ( 4 mg ) in group O , metoclopramide ( 10 mg ) in group M , and saline ( 2 mL ) in group P. Total incidence of nausea and vomiting , rescue antiemetic requirement , pain scores , and any adverse effects were recorded at 3 observational periods ( 0-2 hours , 2-12 hours , and 12-24 hours ) .
RESULTS	Total rates of PON , POV , and PONV were significantly higher in group P at 0-2 hours and 2-12 hours compared with group D , O , and M ( P < .05 ) .
RESULTS	There was no difference in PON , POV , and PONV among D , O , and M groups .
RESULTS	None of the groups differed in PONV in the subsequent 12-24 hours .
RESULTS	Number of patients requiring rescue antiemetic was significantly higher in group P than the other groups at 0-2 hours ( 10 % , 10 % , 15 % , and 45 % in group D , O , M , and P ) ( P < .05 ) .
CONCLUSIONS	Prophylactic IV dexamethasone 8 mg significantly reduces the incidence of PONV in gynecologic surgery .
CONCLUSIONS	At this dosage , dexamethasone is as effective as ondansetron 4 mg and metoclopramide 10 mg , and is more-effective than placebo .

###16596114
OBJECTIVE	The purpose of this study was to examine whether training status and plasma hormones ( estradiol -- E2 , progesterone -- P , luteinizing hormone -- LH , and follicle-stimulating hormone -- FSH ) have an effect on selected immune indexes during or following an acute bout of exercise .
METHODS	Seven female triathletes ( TRI ) and 7 recreationally active ( REC ) females were randomly assigned to rest ( RE ) and exercise ( EX ) trials during the late-follicular menstrual phase ( LF ) .
METHODS	The EX was 1 hour of cycling at 63.1 + / -6 % VO2peak ( TRI ) and 61 + / -5.1 % VO2peak ( REC ) and RE was 1 hour of sitting .
METHODS	Blood was drawn for both trials at baseline ( 0H ) , 1 hour ( 1H ) , and at 3 hours ( 3H ) .
RESULTS	Positive correlations were found between E2 and CD19 + cells for both groups as well as P and CD8 + cells for the REC group .
RESULTS	E2 increased during EX and returned to baseline at 3HEX for both groups , however , LH remained elevated at 3HEX for REC .
RESULTS	There were significant exercise time effects for CD3 + , CD4 + , CD8 + , and CD3 - CD16 + CD56 + cells .
RESULTS	The NCMC and 1:1 were elevated at 1HEX for both groups and returned to baseline by 3HEX .
RESULTS	During RE , CD3 - CD16 + CD56 + cell numbers for both groups and NCMC for REC remained elevated at 3HRE .
CONCLUSIONS	E2 and P correlated with CD19 + and CD8 + cells , respectively .
CONCLUSIONS	Although there were transient exercise-induced changes in immune indexes and E2 and LH , with LH remaining elevated at 3HEX for REC , both training groups elicited similar responses for plasma hormones , lymphocyte subpopulations , and NCMC .

###18698292
OBJECTIVE	To compare baseline demographic , systemic , and ocular characteristics within age and racial subgroups among participants in this Diabetic Retinopathy Clinical Research Network clinical trial and to compare this cohort with other cohorts enrolled in phase 3 clinical trials for diabetic retinopathy .
METHODS	Thirty-six month , randomized , controlled , multicenter clinical trial of 693 participants with diabetic macular edema enrolled at 88 clinical sites in the United States .
METHODS	Participants were categorized into self-reported race/ethnicity subgroups and into one of three age groups : 18 to < 60 , 60 to < 70 , and 70 and older .
RESULTS	Mean age of participants was 63 years , 72 % were white , and median visual acuity letter score was 62 ( approximately 20/63 ) .
RESULTS	No substantial difference was identified between racial subgroups for any baseline variable .
RESULTS	Older participants were more likely to have Type 2 diabetes mellitus and longer duration disease .
RESULTS	The most frequent levels of diabetic retinopathy among 840 study eyes were moderate ( level 43 ) to moderately severe ( level 47 ) nonproliferative disease .
CONCLUSIONS	While the racial composition of this cohort does not differ from other cohorts in large phase 3 trials that have evaluated participants with diabetic retinopathy , the inclusion of many subjects over age 70 and a better level of glycemic control are distinguishing features .

###20601692
BACKGROUND	We examined correlates of infant morbidity and mortality within the first 3 months of life among HIV-exposed infants receiving post-exposure antiretroviral prophylaxis in South Africa .
METHODS	We conducted a prospective cohort study of 848 mother-child dyads .
METHODS	Multivariable Cox proportional hazards models were used .
RESULTS	The main causes of infant morbidity were gastrointestinal and respiratory infections .
RESULTS	Morbidity was higher with infant HIV infection ( HR : 2.61 ; 95 % CI : 1.40-4 .85 ; p = 0.002 ) and maternal plasma viral load ( PVL ) > 100,000 copies ml ( HR : 1.87 ; 95 % CI : 1.01-3 .48 ; p = 0.048 ) , and lower with maternal age < 20 years ( HR : 0.25 ; 95 % CI : 0.07-0 .88 ; p = 0.031 ) .
RESULTS	Mortality was higher with infant HIV infection ( HR : 4.10 ; 95 % CI : 1.18-14 .31 ; p = 0.027 ) and maternal PVL > 100,000 copies ml ( HR : 6.93 ; 95 % CI : 1.64-29 .26 ; p = 0.008 ) .
RESULTS	Infant feeding status did not influence the risk of morbidity nor mortality .
CONCLUSIONS	Future interventions that minimize pediatric HIV infection and reduce maternal viremia , which are the main predictors of child health soon after birth , will impact positively on infant health outcomes .

###17043133
OBJECTIVE	Although low birth weight premature infants and parents are at high risk for adverse health outcomes , there is a paucity of studies that test early NICU interventions with parents to prevent the development of negative parent-infant interaction trajectories and to reduce hospital length of stay .
OBJECTIVE	Our objective was to evaluate the efficacy of an educational-behavioral intervention program ( ie , Creating Opportunities for Parent Empowerment ) that was designed to enhance parent-infant interactions and parent mental health outcomes for the ultimate purpose of improving child developmental and behavior outcomes .
METHODS	A randomized , controlled trial was conducted with 260 families with preterm infants from 2001 to 2004 in 2 NICUs in the northeast United States .
METHODS	Parents completed self-administered instruments during hospitalization , within 7 days after infant discharge , and at 2 months ' corrected age .
METHODS	Blinded observers rated parent-infant interactions in the NICU .
METHODS	All participants received 4 intervention sessions of audiotaped and written materials .
METHODS	Parents in the Creating Opportunities for Parent Empowerment program received information and behavioral activities about the appearance and behavioral characteristics of preterm infants and how best to parent them .
METHODS	The comparison intervention contained information regarding hospital services and policies .
METHODS	Parental stress , depression , anxiety , and beliefs ; parent-infant interaction during the NICU stay ; NICU length of stay ; and total hospitalization were measured .
RESULTS	Mothers in the Creating Opportunities for Parent Empowerment program reported significantly less stress in the NICU and less depression and anxiety at 2 months ' corrected infant age than did comparison mothers .
RESULTS	Blinded observers rated mothers and fathers in the Creating Opportunities for Parent Empowerment program as more positive in interactions with their infants .
RESULTS	Mothers and fathers also reported stronger beliefs about their parental role and what behaviors and characteristics to expect of their infants during hospitalization .
RESULTS	Infants in the Creating Opportunities for Parent Empowerment program had a 3.8-day shorter NICU length of stay ( mean : 31.86 vs 35.63 days ) and 3.9-day shorter total hospital length of stay ( mean : 35.29 vs 39.19 days ) than did comparison infants .
CONCLUSIONS	A reproducible educational-behavioral intervention program for parents that commences early in the NICU can improve parent mental health outcomes , enhance parent-infant interaction , and reduce hospital length of stay .

###16197655
OBJECTIVE	To compare efficacy and safety of milnacipran and fluoxetine in a population of Korean patients with major depression .
METHODS	The design was a multi-centre , randomised , comparative clinical study .
METHODS	Patients with major depression ( DSM-IV diagnostic criteria ) scoring over 17 points on the 17-item Hamilton Depression Scale ( HAM-D ) and over 21 points on the Montgomery-Asberg Depression Rating Scale ( MADRS ) were recruited and randomised to receive milnacipran ( 50 mg/day increasing after 1 week to 100 mg/day ) or fluoxetine ( 20 mg/day ) for 6 weeks .
METHODS	All previous medication was stopped at least 7 days before entry into the study .
METHODS	Patients were evaluated ( HAM-D , MADRS and clinical global impression scale , CGI ) at baseline and after 1 , 2 , 4 and 6 weeks of treatment .
METHODS	All adverse events which developed during the study period were recorded .
RESULTS	70 patients ( milnacipran 39 ; fluoxetine 31 ) were included in the study .
RESULTS	Total score on both HAM-D , MADRS and CGI decreased significantly in both groups after 1 week and continued to decrease throughout the study .
RESULTS	There was no significant difference between the two groups for any measurement at any time point .
RESULTS	Both antidepressants were well tolerated .
RESULTS	In the milnacipran group , 13 patients reported 28 adverse reactions , and in the fluoxetine group 11 patients reported 18 adverse reactions .
RESULTS	Two patients discontinued due to adverse events in the milnacipran group and three in the fluoxetine group .
RESULTS	There were no clinically significant modifications in vital signs , routine blood laboratory tests , biochemistry or ECG throughout the study .
RESULTS	Nausea and headache were the most frequently reported adverse events with milnacipran while digestive disturbances , diarrhoea and insomnia were more common with fluoxetine .
CONCLUSIONS	Milnacipran , like fluoxetine , was found to be effective and well tolerated for the treatment of major depression in this population of depressed Korean patients .
CONCLUSIONS	Principal limitations of the study were its open design , its small sample size and its relatively short duration .

###23341981
OBJECTIVE	Impaired liver regeneration is associated with a poor outcome in patients with decompensated alcoholic liver disease ( ALD ) .
OBJECTIVE	We assessed whether autologous bone marrow mononuclear cell transplantation ( BMMCT ) improved liver function in decompensated ALD .
METHODS	58 patients ( mean age 54 yrs ; mean MELD score 19 , all with cirrhosis , 81 % with alcoholic steatohepatitis at baseline liver biopsy ) were randomized early after hospital admission to standard medical therapy ( SMT ) alone ( n = 30 ) , including steroids in patients with a Maddrey 's score 32 , or combined with G-CSF injections and autologous BMMCT into the hepatic artery ( n = 28 ) .
METHODS	Bone marrow cells were harvested , isolated and reinfused the same day .
METHODS	The primary endpoint was a 3 points decrease in the MELD score at 3 months , corresponding to a clinically relevant improvement in liver function .
METHODS	Liver biopsy was repeated at week 4 to assess changes in Ki67 + / CK7 + hepatic progenitor cells ( HPC ) compartment .
RESULTS	Both study groups were comparable at baseline .
RESULTS	After 3 months , 2 and 4 patients died in the BMMCT and SMT groups , respectively .
RESULTS	Adverse events were equally distributed between groups .
RESULTS	Moderate alcohol relapse occurred in 31 % of patients .
RESULTS	The MELD score improved in parallel in both groups during follow-up with 18 patients ( 64 % ) from the BMMCT group and 18 patients ( 53 % ) from the SMT group reaching the primary endpoint ( p = 0.43 ( OR 1.6 , CI 0.49-5 .4 ) in an intention to treat analysis .
RESULTS	Comparing liver biopsy at 4 weeks to baseline , steatosis improved ( p < 0.001 ) , and proliferating HPC tended to decrease in both groups ( -35 and -33 % , respectively ) .
CONCLUSIONS	Autologous BMMCT , compared to SMT is a safe procedure but did not result in an expanded HPC compartment or improved liver function .
CONCLUSIONS	These data suggest either insufficient regenerative stimulation after BMMCT or resistance to liver regenerative drive in patients with decompensated alcoholic cirrhosis .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN83972743 .

###11450926
BACKGROUND	There is increasing evidence that clinical guidelines can lead to improvements in clinical care .
BACKGROUND	However , they are not self-implementing .
BACKGROUND	Outreach visits may improve prescribing behaviour .
METHODS	Within a before-and-after pragmatic randomized controlled trial , involving all general practices in one health district , routine methods were used to distribute guidelines for management of Helicobacter pylori eradication .
METHODS	Intervention practices were offered a visit and the conduct of an audit by a pharmacist trained in the techniques of outreach visiting .
METHODS	The intervention was evaluated using level three Prescribing Analysis and Cost ( PACT ) data for metronidazole and omeprazole for the two 12 month periods around the introduction of the guidelines .
RESULTS	Of the 38 intervention practices 19 accepted an outreach visit and three accepted the offer of an audit .
RESULTS	There was a significant increase in omeprazole use during the study of 0.24 [ 95 per cent confidence interval ( CI ) +0.19 to +0.29 ] dose units per year but no effect from the offer [ -0.02 ( 95 per cent CI -0.12 to +0.08 ) dose units ] or acceptance of a visit [ -0.03 ( 95 per cent CI -0.15 to +0.08 ) dose units ] .
RESULTS	The results for metronidazole were similar , with an increase in use of 0.028 ( 95 per cent CI +0.018 to +0.038 ) dose units per year .
RESULTS	The effect of the intervention was a non-significant change in prescribing of -0.005 ( 95 per cent CI -0.025 to +0.015 ) dose units .
RESULTS	Accepting a visit had little effect on prescribing : a change of 0.003 ( 95 per cent CI -0.021 to +0.027 ) dose units .
CONCLUSIONS	The routine use of untargeted outreach visiting is probably not a worthwhile strategy .

###16882533
OBJECTIVE	To explore the potential association between asbestos exposure and risk of autoimmune disease , we conducted a case-control study among a cohort of 7,307 current and former residents of Libby , Montana , a community with historical occupational and environmental exposure to asbestos-contaminated vermiculite .
METHODS	Cases were defined as those who reported having one of three systemic autoimmune diseases ( SAIDs ) : systemic lupus erythematosus , scleroderma , or rheumatoid arthritis ( RA ) .
METHODS	Controls were randomly selected at a 3:1 ratio from among the remaining 6,813 screening participants using frequency-matched age and sex groupings .
RESULTS	The odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for SAIDs among those > or = 65 years of age who had worked for the vermiculite mining company were 2.14 ( 95 % CI , 0.90-5 .10 ) for all SAIDs and 3.23 ( 95 % CI , 1.31-7 .96 ) for RA .
RESULTS	In this age group , exposure to asbestos while in the military was also an independent risk factor , resulting in a tripling in risk .
RESULTS	Other measures of occupational exposure to vermiculite indicated 54 % and 65 % increased risk for SAIDs and RA , respectively .
RESULTS	Those who had reported frequent contact with vermiculite through various exposure pathways also demonstrated elevated risk for SAIDs and RA .
RESULTS	We found increasing risk estimates for SAIDs with increasing numbers of reported vermiculite exposure pathways ( p < 0.001 ) .
CONCLUSIONS	These preliminary findings support the hypothesis that asbestos exposure is associated with autoimmune disease .
CONCLUSIONS	Refined measurements of asbestos exposure and SAID status among this cohort will help to further clarify the relationship between these variables .

###22082432
OBJECTIVE	This study 's objective was to examine the effectiveness of Sanyinjiao point ( SP6 ) acupressure on women 's general health .
METHODS	This was a randomized , single-blind clinical trial .
METHODS	The setting for this trial was at Medical University , Bojnoord University of Medical Science , Bojnoord , Iran .
METHODS	Eighty-six ( 86 ) university students were recruited for this study .
METHODS	Their demographic characteristics were gathered before the intervention commenced .
METHODS	Participants completed General Health Questionnaires ( GHQ ) prior to participation .
METHODS	Next , they were randomly assigned to either the acupressure-receiving group or the sham-pressure-receiving group .
METHODS	The study group received acupressure at the Sanyinjiao point , while the control group received sham pressure .
METHODS	Both groups completed GHQ after both the first and second months of intervention .
METHODS	Data analysis was carried out using SPSS version 13.5 for Windows .
RESULTS	The mean age of those who completed the study was 20.841.64 years .
RESULTS	Mean scores of GHQs were similar between groups before intervention ( p > 0.05 ) .
RESULTS	The general health of participants in both groups improved after intervention , and the amelioration in four domains was significant in the groups ( p < 0.05 within group ) .
RESULTS	It was found that acupressure was more effective than sham pressure .
RESULTS	In addition , there was a statistically significant difference between the two groups in the four domains of their general heath after the first month of the intervention ( p < 0.0001 ) .
RESULTS	Furthermore , the general health status of the participants changed much more after the second month in both the acupressure intervention and the sham pressure groups ; nevertheless , acupressure was more effective than sham pressure ( p < 0.05 ) .
CONCLUSIONS	Both acupressure and sham pressure were effective in promoting women 's general health ; nevertheless , the efficacy of acupressure was more than that of sham pressure .
CONCLUSIONS	SP6 acupressure could be regarded as a self-manageable approach to improve women 's general health .

###21074752
OBJECTIVE	The current study examined the efficacy of an early intervention based on acceptance and commitment therapy ( ACT ) for depressive symptomatology .
OBJECTIVE	The ACT intervention is aimed at increasing the acceptance of negative thoughts and emotions and living a mindful and value-based life .
METHODS	Adults with mild to moderate depressive symptomatology were randomly assigned to the ACT intervention ( n = 49 ) or to a waiting list ( n = 44 ) .
METHODS	The mean age of the participants was 49 years .
METHODS	The majority of the participants was female and of Dutch origin .
METHODS	All the participants completed measures before and after the intervention , as well as three months later at follow-up to assess depression ( CES-D ) , anxiety ( HADS-A ) , fatigue ( CIS ) , alcohol use and acceptance ( AAQ-II ) .
RESULTS	The ACT intervention led to statistically significant reduction in depressive symptomatology ( Cohen 's d = .60 ) .
RESULTS	These reductions were maintained at the three-month follow-up .
RESULTS	Also significant reductions in anxiety and fatigue were observed .
RESULTS	Moreover , mediational analysis showed that the improvement of acceptance during the intervention mediated the effects of the intervention on depressive symptomatology at follow-up .
CONCLUSIONS	These findings suggest that an early intervention based on ACT , aimed at increasing acceptance , is effective in reducing depressive symptomatology .

###22159931
BACKGROUND	Gabapentin and pregabalin have been compared in studies conducted on management of neuropathic and postoperative pain .
BACKGROUND	In neuropathic pain studies , the analgesic effects of the two drugs were compared , and pregabalin has been found to be more potent .
BACKGROUND	However , in postoperative pain studies , the effects of each drug were examined separately .
BACKGROUND	This study compared the analgesic effects of pregabalin ( 300 mg day-1 ) , gabapentin ( 1,200 mg day-1 ) and a placebo in managing postoperative pain following laminectomy and discectomy .
METHODS	90 patients were randomly assigned to three groups ( pregabalin , gabapentin and placebo ) of 30 patients each .
METHODS	Pregabalin 150 mg , gabapentin 600 mg and a placebo were administered every 12 hours , two times pre - and post surgery .
METHODS	Study data collected included morphine consumption , Visual Analogue Scale records , preoperative anxiety , patient satisfaction , adverse effects and observation notes .
RESULTS	In the gabapentin and pregabalin groups , overall morphine consumption , preoperative anxiety , pruritus , postoperative shivering were significantly lower ( p-value less than 0.05 for all ) , and patient satisfaction was significantly higher than those in the placebo group ( p-value less than 0.05 ) .
CONCLUSIONS	This study showed that both pregabalin 300 mg day-1 and gabapentin 1,200 mg day-1 have more analgesic , anxiolytic and opioid-sparing effects , higher patient satisfaction and are more effective for preventing postoperative shivering than the placebo following lumbar laminectomy and discectomy .
CONCLUSIONS	The findings revealed that pregabalin 300 mg day-1 had equivalent analgesic , adverse and opioid-sparing effects and patient satisfaction as gabapentin 1,200 mg day-1 .

###21527615
OBJECTIVE	The aim of this study was to investigate the usefulness of sonography for verifying tracheal tube placement within 3 seconds in adult surgical patients .
METHODS	This was a blinded prospective randomized study .
METHODS	The anesthesiologist placed the tracheal tube randomly in the trachea ( n = 75 ) or in the esophagus ( n = 75 ) with direct laryngoscopy .
METHODS	A sonographer identified all tracheal and esophageal intubations .
METHODS	The transducer was placed transversely on the neck just superior to the suprasternal notch .
METHODS	The position of the tracheal tube was determined by the sonographer within 3 seconds of tracheal tube placement in the trachea or in the esophagus .
RESULTS	We successfully identified 150 correct tracheal tube placements in tracheas and esophagi , resulting in sensitivity of 100 % ( 95 % confidence interval , 84 % -100 % ) and specificity of 100 % ( 95 % confidence interval , 84 % -100 % ) .
CONCLUSIONS	This investigation shows that sonography for confirming tracheal intubation is a fast and effective technique .

###19715709
BACKGROUND	Children with Attention Deficit Hyperactivity Disorder ( ADHD ) have deficits in motivation and attention that can be ameliorated with the indirect dopamine agonist Methylphenidate ( MPH ) .
BACKGROUND	We used functional magnetic resonance imaging ( fMRI ) to investigate the effects of MPH in medication-nave children with ADHD on the activation and functional connectivity of `` cool '' attentional as well as `` hot '' motivation networks .
METHODS	13 medication-nave children with ADHD were scanned twice , under either an acute clinical dose of MPH or Placebo , in a randomised , double-blind design , while they performed a rewarded continuous performance task that measured vigilant selective attention and the effects of reward .
METHODS	Brain activation and functional connectivity was compared to that of 13 healthy age-matched controls to test for normalisation effects of MPH .
RESULTS	MPH normalised performance deficits that were observed in children with ADHD compared to controls .
RESULTS	Under placebo , children with ADHD showed reduced activation and functional inter-connectivity in bilateral fronto-striato-parieto-cerebellar networks during the attention condition , but enhanced activation in the orbitofrontal and superior temporal cortices for reward .
RESULTS	MPH within children with ADHD enhanced the activation of fronto-striato-cerebellar and parieto-temporal regions .
RESULTS	Compared to controls , MPH normalised differences during vigilant attention in parieto-temporal activation and fronto-striatal and fronto-cerebellar connectivity ; MPH also normalised the enhanced orbitofrontal activation in children with ADHD in response to reward .
CONCLUSIONS	MPH normalised attention differences between children with ADHD and controls by both up-regulation of dysfunctional fronto-striato-thalamo-cerebellar and parieto-temporal attention networks and down-regulation of hyper-sensitive orbitofrontal activation for reward processing .
CONCLUSIONS	MPH thus shows context-dependent dissociative modulation of both motivational and attentional neuro-functional networks in children with ADHD .

###18267029
BACKGROUND	The mechanisms thorough which spinal manipulative therapy ( SMT ) exerts clinical effects are not established .
BACKGROUND	A prior study has suggested a dorsal horn modulated effect ; however , the role of subject expectation was not considered .
BACKGROUND	The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT .
METHODS	Sixty healthy subjects agreed to participate and underwent quantitative sensory testing ( QST ) to their leg and low back .
METHODS	Next , participants were randomly assigned to receive a positive , negative , or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception .
METHODS	Following the instructional set , all subjects received SMT and underwent repeat QST .
RESULTS	No interaction ( p = 0.38 ) between group assignment and pain response was present in the lower extremity following SMT ; however , a main effect ( p < 0.01 ) for hypoalgesia was present .
RESULTS	A significant interaction was present between change in pain perception and group assignment in the low back ( p = 0.01 ) with participants receiving a negative expectation instructional set demonstrating significant hyperalgesia ( p < 0.01 ) .
CONCLUSIONS	The current study replicates prior findings of c - fiber mediated hypoalgesia in the lower extremity following SMT and this occurred regardless of expectation .
CONCLUSIONS	A significant increase in pain perception occurred following SMT in the low back of participants receiving negative expectation suggesting a potential influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed .

###10077372
OBJECTIVE	The incidence of wound infection in coronary artery surgery is low , but there is an appreciable mortality associated with sternal infection .
OBJECTIVE	In other fields of surgery there is evidence that an all disposable paper gown and drape system has protective advantages over a fabric system .
OBJECTIVE	Using an established wound scoring system ( ASEPSIS ) , we investigated this in a prospective , randomised trial of patients undergoing cardiac surgery .
METHODS	505 patients undergoing isolated coronary artery surgery in a single hospital over an 18 month period were randomised to either a disposable , paper drape system or re-usable fabric drapes .
METHODS	Allocation was stratified according to whether or not the patient had had previous coronary artery surgery .
METHODS	Patients were followed for 3 months .
METHODS	Total infection scores for each wound were calculated from daily scores collected in hospital together with the scores at six weeks and three months .
RESULTS	The two randomised groups were otherwise well matched .
RESULTS	Full follow-up information was available for 464 ( 92 % ) patients .
RESULTS	There was no evidence of any difference in rates of sternal or leg wound infection between the two groups ( P = 0.87 and 0.62 , respectively ) .
RESULTS	Women were more likely to have infected sternal wounds ( P = 0.17 ) and significantly more likely to have infected leg wounds ( P = 0.04 ) .
RESULTS	Patients with sternal wound infections had a significantly higher body mass index ( P = 0.001 ) .
RESULTS	High Parsonnet scores and increased time on ventilation were significantly associated with leg wound but not sternal infections .
RESULTS	For both wound sites , patients with infections had spent longer in the operating theatre .
CONCLUSIONS	In a randomised controlled study of patients undergoing coronary artery surgery we found that the use of paper drapes and gowns conferred no benefit over a reusable fabric in terms of post-operative wound infection .
CONCLUSIONS	Although females and diabetics are more likely to experience this complication , an important additional risk factor is an extended operating time .

###11832851
BACKGROUND	The objectives of the study were to compare the tension-free mesh repair with non-meash conventional repair of groin hernia .
METHODS	In the past two years in 299 consecutive unselected patients 339 inguinal hernia repairs were carried out .
METHODS	They randomly allocated to undergo either a non-meash modified Bassini 's repair ( n = 164 ) or a tension-free mesh repair ( n = 175 ) .
METHODS	The latter group consisted of laparoscopic TAPP repair ( n = 46 ) and open onlay patch repair ( n = 64 ) or plug and patch repair ( n = 65 ) .
METHODS	Operation time , postoperative pain and complications , hospital stay , return to work and recurrence were assessed .
METHODS	Statistical analysis was made using the `` t '' - Student test .
RESULTS	The characteristics of the patients in each group and the operation time did not differ significantly .
RESULTS	The planned procedure was completed in all and no death occurred .
RESULTS	The analgesic requirements ( none 2.5 vs 56.4 % , opiods 77 vs 23.6 % ) , complication rate ( 9.4 vs 4.3 % ) , hospital stay ( 4.2 vs 1.8 days ) , return to work ( 17.2 vs 7.3 days ) and recurrence rate ( 5.5 vs 1.2 % ) in non-mesh group were more than in the mesh group .
RESULTS	All differences were statistically significant ( p < 0.05 ) .
RESULTS	Among the three subgroups of mesh group no statistically significant differences ( p > 0.05 ) were found .
CONCLUSIONS	The tension-free mesh repair either open or laparoscopic provides excellent results with better short-term outcome and lower recurrence rate than non-mesh modified Bassini 's repair .

###18673350
BACKGROUND	Acetaminophen and diphenhydramine are commonly used as pretransfusion medications to prevent transfusion reactions .
BACKGROUND	The purpose of this study was to prospectively compare the risk of transfusion reactions in hematology/oncology patients who receive acetaminophen with diphenhydramine or placebo before transfusion .
METHODS	A randomized , double-blind , placebo-controlled transfusion reaction study of 315 eligible patients was performed .
METHODS	Inclusion criteria were patients aged 18 to 65 years admitted to the leukemia or bone marrow transplant ( BMT ) services .
METHODS	Patients were excluded if they had a known allergy to either acetaminophen or diphenhydramine or had a documented history of a febrile or allergic transfusion reaction .
METHODS	All blood products were administered using a leukofilter .
METHODS	Study medications were given 30 minutes before transfusions and no other acetaminophen or diphenhydramine was given within 4 hours of administration of the study medications .
METHODS	Patients were monitored for the development of reaction symptoms within 4 hours after the transfusion .
RESULTS	A total of 154 active drug patients were compared to 161 placebo patients .
RESULTS	There was no significant difference in the overall risk of transfusion reactions between the two groups .
RESULTS	However , analysis of specific reaction types revealed a significant decrease in the risk of febrile reactions when pretransfusion medication is used in addition to bedside leukoreduction .
CONCLUSIONS	Pretransfusion medication of leukemia or BMT patients without a history of transfusion reaction does not decrease the overall risk of transfusion reactions .
CONCLUSIONS	However , pretransfusion medication may decrease the risk of febrile nonhemolytic transfusion reactions to leukoreduced blood products .

###24486335
BACKGROUND	Subcutaneous ondansetron facilitated by recombinant human hyaluronidase PH20 ( rHuPH20 ) is an alternative for treating nausea/vomiting in patients who can not receive ondansetron by other routes of administration .
OBJECTIVE	Based on preclinical results in minipigs , a Phase I study was designed to assess the tolerability and pharmacokinetic properties of subcutaneous ondansetron + rHuPH20 compared with intramuscular , intravenous , or oral ondansetron monotherapy in healthy volunteers .
METHODS	In a crossover design , 3 minipigs were dosed with subcutaneous ondansetron 0.08 mg/kg + rHuPH20 , or as intramuscular or intravenous monotherapy , for the evaluation of plasma ondansetron concentrations and local tolerability .
METHODS	In a randomized , open-label , 4-way crossover study , subjects received a randomized sequence of SC ondansetron 4 mg + rHuPH20 , or ondansetron monotherapy IM ( 4 mg ) , IV ( 4 mg ) , or PO ( 8 mg ) , over 4 daily visits .
METHODS	Study participants included healthy volunteers aged 19 to 65 years with adequate venous access in both upper extremities and no history of QT-interval prolongation .
METHODS	Primary tolerability end points ( administration-site observations , systemic adverse events [ AEs ] , and subject-assessed pain ) were assessed , and pharmacokinetic parameters ( AUC , Cmax , Tmax , t ) were computed to compare relative rate and extent of systemic exposure .
METHODS	Results were described using summary statistics , and bioequivalence was determined with a linear mixed-effects model .
RESULTS	In the preclinical study , no adverse events or significant local reactions were observed .
RESULTS	The Cmax ( 45.8 ng/mL at 0.08 hour ) with subcutaneous administration + rHuPH20 was 83 % greater and was achieved 68 % faster than with intramuscular administration ( Cmax = 25 ng/mL at 0.25 hour ) .
RESULTS	In the clinical study , a total of 12 subjects ( 7 women , 5 men ; white majority ; mean age , 44.8 ) were randomized .
RESULTS	The majority of AEs were at the injection site , mild in severity , and transient .
RESULTS	After subcutaneous administration of ondansetron + rHuPH20 , geometric mean Cmax was 35 % higher than with intramuscular ondansetron , 43 % lower than with intravenous ondansetron , and 126 % higher than with oral ondansetron ( corrected for dose ) .
RESULTS	Bioequivalence tests demonstrated that systemic exposure after subcutaneous administration was similar to that after intramuscular or intravenous administration and significantly greater than that after oral administration .
CONCLUSIONS	Subcutaneous ondansetron + rHuPH20 was generally well-tolerated .
CONCLUSIONS	Subcutaneous dosing resulted in an extent of systemic exposure similar to that with intramuscular or intravenous dosing and greater than that with oral administration , and may be an option for clinical administration of ondansetron .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01572012 .

###23845099
OBJECTIVE	To determine whether cognitive behavioural interventions would improve the quality of life in Chinese heroin addicts .
BACKGROUND	Drug dependence is one of the most serious health problems in the world , representing a real menace to mental and somatic health .
BACKGROUND	However , effects of cognitive behavioural interventions on quality of life in Chinese heroin addicts are unclear .
METHODS	This randomised controlled study was conducted at a Drug-withdrawal Rehabilitation Center in China .
METHODS	Following ethics approval and heroin addicts ' consent , 240 heroin addicts were randomly assigned to two groups .
METHODS	The experimental group ( n = 120 ) received a six-month cognitive behavioural intervention comprising education intervention and behavioural intervention developed by the investigators .
METHODS	The control group ( n = 120 ) received the hospital 's routine care .
METHODS	The effects of the interventions on patients ' quality of life were evaluated at baseline and six months and were compared .
METHODS	A Chinese version of Quality of Life in Drug Addiction Questionnaire was used in this study .
METHODS	Usefulness of the intervention and usual community services was evaluated at six months .
RESULTS	The quality of life of participants with heroin addiction with physical and psychological disorders is poor .
RESULTS	The experimental group showed a significant improvement in quality of life after nurse-managed cognitive behavioural intervention .
CONCLUSIONS	The quality of life and the health status of Chinese heroin addicts were improved after they received a nurse-managed cognitive behavioural intervention .
CONCLUSIONS	Appropriate nurse-managed cognitive behavioural intervention for heroin addicts can improve their quality of life and promote their health .
CONCLUSIONS	It is important for clinical nurses to understand cognitive behavioural therapy , appraisal and coping to apply knowledge in practice when dealing with a client who has heroin addiction .

###16762887
OBJECTIVE	To evaluate the efficacy of Avastin in combination with irinotecan for metastatic colorectal cancer .
METHODS	Ninety patients were randomly divided into 3 equal groups to receive Avastin plus irinotecan ( group A ) , FOLFIRI ( group B ) and FOLFOX7 ( group C ) for two cycles , respectively .
METHODS	The response rate and changes in tumor maker levels were observed .
RESULTS	The tumor response rate was 43.3 % in group A , 27.7 % in group B and 30.0 % in group C.
RESULTS	The disease control rate ( complete response + partial response + stable disease ) was 80 % in group A , 53.3 % in group B and 50.0 % in group C. Obvious changes in tumor marker levels were observed in the 3 groups after treatment , which were most conspicuous in group A ( P < 0.05 ) .
CONCLUSIONS	The addition of Avastin to irinotecan chemotherapy results in significant improvement of clinical efficacy in patients with metastatic colorectal cancer .

###24499812
BACKGROUND	Tubal ectopic pregnancy can be surgically treated by salpingectomy , in which the affected Fallopian tube is removed , or salpingotomy , in which the tube is preserved .
BACKGROUND	Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy , salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects , although little evidence exists to support this assumption .
BACKGROUND	We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy .
METHODS	In this open-label , multicentre , international , randomised controlled trial , women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy .
METHODS	The primary outcome was ongoing pregnancy by natural conception .
METHODS	Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95 % CI , calculated by Cox proportional-hazards analysis with a time horizon of 36 months .
METHODS	Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy ( expressed as relative risks [ RRs ] with 95 % CIs ) and ongoing pregnancy after ovulation induction , intrauterine insemination , or IVF .
METHODS	The researchers who collected data for fertility outcomes were masked to the assigned intervention , but patients and the investigators who analysed the data were not .
METHODS	All endpoints were analysed by intention to treat .
METHODS	We also did a ( non-prespecified ) meta-analysis that included the findings from the present trial .
METHODS	This trial is registered , number ISRCTN37002267 .
RESULTS	446 women were randomly assigned between Sept 24 , 2004 , and Nov 29 , 2011 , with 215 allocated to salpingotomy and 231 to salpingectomy .
RESULTS	Follow-up was discontinued on Feb 1 , 2013 .
RESULTS	The cumulative ongoing pregnancy rate was 607 % after salpingotomy and 562 % after salpingectomy ( fecundity rate ratio 106 , 95 % CI 081-138 ; log-rank p = 0678 ) .
RESULTS	Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group ( 14 [ 7 % ] vs 1 [ < 1 % ] ; RR 150 , 20-1134 ) .
RESULTS	Repeat ectopic pregnancy occurred in 18 women ( 8 % ) in the salpingotomy group and 12 ( 5 % ) women in the salpingectomy group ( RR 16 , 08-33 ) .
RESULTS	The number of ongoing pregnancies after ovulation induction , intrauterine insemination , or IVF did not differ significantly between the groups .
RESULTS	43 ( 20 % ) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding .
RESULTS	Our meta-analysis , which included our own results and those of one other study , substantiated the results of the trial .
CONCLUSIONS	In women with a tubal pregnancy and a healthy contralateral tube , salpingotomy does not significantly improve fertility prospects compared with salpingectomy .
BACKGROUND	Netherlands Organisation for Health Research and Development ( ZonMW ) , Region Vstra Gtaland Health & Medical Care Committee .

###23778373
METHODS	Prospective randomized controlled trial .
OBJECTIVE	To study the outcome of anterior cervical decompression and fusion combined with a structured physiotherapy program compared with the same physiotherapy program alone for patients with cervical radiculopathy .
BACKGROUND	Knowledge concerning the effects of interventions for patients with cervical radiculopathy is scarce due to a lack of randomized studies .
METHODS	Sixty-three patients were randomized to surgery with postoperative physiotherapy ( n = 31 ) or physiotherapy alone ( n = 32 ) .
METHODS	The surgical group was treated with anterior cervical decompression and fusion .
METHODS	The physiotherapy program included general/specific exercises and pain-coping strategies .
METHODS	The outcome measures were disability ( Neck Disability Index ) , neck and arm pain intensity ( visual analogue scale ) , and the patient 's global assessment .
METHODS	Patients were followed for 24 months .
RESULTS	The result from the repeated-measures analysis of variance showed no significant between-group difference for Neck Disability Index ( P = 0.23 ) .
RESULTS	For neck pain intensity , the repeated-measures analysis of variance showed a significant between-group difference during the study period in favor of the surgical group ( P = 0.039 ) .
RESULTS	For arm pain intensity , no significant between-group differences were found according to the repeated-measures analysis of variance ( P = 0.580 ) .
RESULTS	Eighty-seven percent of the patients in the surgical group rated their symptoms as `` better/much better '' at the 12-month follow-up compared with 62 % in the nonsurgical group ( P < 0.05 ) .
RESULTS	At 24 months , the corresponding figures were 81 % and 69 % ( P = 0.28 ) .
RESULTS	The difference was significant only at the 12-month follow-up in favor of the surgical group .
RESULTS	Significant reduction in Neck Disability Index , neck pain , and arm pain compared with baseline was seen in both groups ( P < 0.001 ) .
CONCLUSIONS	In this prospective , randomized study of patients with cervical radiculopathy , it was shown that surgery with physiotherapy resulted in a more rapid improvement during the first postoperative year , with significantly greater improvement in neck pain and the patient 's global assessment than physiotherapy alone , but the differences between the groups decreased after 2 years .
CONCLUSIONS	Structured physiotherapy should be tried before surgery is chosen .
METHODS	2 .

###16517548
OBJECTIVE	To evaluate the rate of over-diagnosis of breast cancer 15 years after the end of the Malm mammographic screening trial .
METHODS	Follow-up study .
METHODS	Malm , Sweden .
METHODS	42 283 women aged 45-69 years at randomisation .
METHODS	Screening for breast cancer with mammography or not ( controls ) .
METHODS	Screening was offered at the end of the randomisation design to both groups aged 45-54 at randomisation but not to groups aged 55-69 at randomisation .
METHODS	Rate of over-diagnosis of breast cancer ( in situ and invasive ) , calculated as incidence in the invited and control groups , during period of randomised design ( period 1 ) , during period after randomised design ended ( period 2 ) , and at end of follow-up .
RESULTS	In women aged 55-69 years at randomisation the relative rates of over-diagnosis of breast cancer ( 95 % confidence intervals ) were 1.32 ( 1.14 to 1.53 ) for period 1 , 0.92 ( 0.79 to 1.06 ) for period 2 , and 1.10 ( 0.99 to 1.22 ) at the end of follow-up .
CONCLUSIONS	Conclusions on over-diagnosis of breast cancer in the Malm mammographic screening trial can be drawn mainly for women aged 55-69 years at randomisation whose control groups were never screened .
CONCLUSIONS	Fifteen years after the trial ended the rate of over-diagnosis of breast cancer was 10 % in this age group .

###20951320
OBJECTIVE	The purpose of this study was to investigate the long-term outcome after elective percutaneous coronary intervention in low-risk patients screened for aspirin and/or clopidogrel responsiveness in the 3T/2R ( Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel ) trial .
BACKGROUND	The impact of aspirin and/or clopidogrel poor response on long-term outcome is debated .
METHODS	Aspirin and clopidogrel response was measured with the VerifyNow system aspirin and P2Y12 assays .
METHODS	After percutaneous coronary intervention ( PCI ) , death , stroke , and myocardial infarction were assessed up to 1 year .
RESULTS	Overall , 1,277 patients were screened , and 826 ( 65 % ) were treated with PCI .
RESULTS	In all , 124 patients were found to be aspirin poor responders , and there were 179 clopidogrel poor responders ( totally , 278 poor responders ) .
RESULTS	The 1-year end point was significantly higher in poor responders as compared to full responders ( 15.8 % vs. 8.6 % , p = 0.002 ) , which is principally due to more myocardial infarction occurrence .
RESULTS	At multivariable analysis , clopidogrel poor response emerged as an independent predictor ( hazard ratio : 1.15 , 95 % confidence interval : 1.03 to 1.28 ) .
RESULTS	Receiver-operator characteristic analysis identifies23 of percentage of platelet inhibition and 208 of P2Y12 reactivity units as optimal cut offs to predict 1-year end point .
RESULTS	Excluding periprocedural events , also peri-PCI myocardial infarction , which is strongly related to aspirin/clopidogrel poor response , was an independent predictor ( hazard ratio : 1.25 , 95 % confidence interval : 1.14 to 1.37 ) .
RESULTS	Glycoprotein IIb/IIIa inhibitor administration reduces this risk in poor responders ( 21.2 % vs. 34.7 % , p = 0.02 ) , but not in full responders ( 6.3 % vs. 6.5 % , p = 0.8 ) .
CONCLUSIONS	Poor response to clopidogrel is an independent predictor of periprocedural myocardial infarction and worse 1-year outcome in low-risk patients undergoing PCI , whereas poor response to aspirin failed to predict a worse outcome .
CONCLUSIONS	Contrary to what was observed in poor responders , glycoprotein IIb/IIa inhibitor therapy failed to provide a benefit in aspirin and/or clopidogrel full responders .

###20716757
BACKGROUND	A catheter-based approach after fibrinolysis is recommended if fibrinolysis is likely to be successful in patients with acute ST-elevation myocardial infarction .
BACKGROUND	We designed a 2x2 randomized , open-label , multicenter trial to evaluate the efficacy and safety of the paclitaxel-eluting stent and tirofiban administered after fibrinolysis but before catheterization to optimize the results of this reperfusion strategy .
RESULTS	We randomly assigned 436 patients with acute ST-elevation myocardial infarction to ( 1 ) bare-metal stent without tirofiban , ( 2 ) bare-metal stent with tirofiban , ( 3 ) paclitaxel-eluting stent without tirofiban , and ( 4 ) paclitaxel-eluting stent with tirofiban .
RESULTS	All patients were initially treated with tenecteplase and enoxaparin .
RESULTS	Tirofiban was started 120 minutes after tenecteplase in those patients randomly assigned to tirofiban .
RESULTS	Cardiac catheterization was performed within the first 3 to 12 hours after inclusion , and stenting ( randomized paclitaxel or bare stent ) was applied to the culprit artery .
RESULTS	The primary objectives were the rate of in-segment binary restenosis of paclitaxel-eluting stent compared with that of bare-metal stent and the effect of tirofiban on epicardial and myocardial flow before and after mechanical revascularization .
RESULTS	At 12 months , in-segment binary restenosis was similar between paclitaxel-eluting stent and bare-metal stent ( 10.1 % versus 11.3 % ; relative risk , 1.06 ; 95 % confidence interval , 0.74 to 1.52 ; P = 0.89 ) .
RESULTS	However , late lumen loss ( 0.04 + / -0.055 mm versus 0.27 + / -0.057 mm , P = 0.003 ) was reduced in the paclitaxel-eluting stent group .
RESULTS	No evidence was found of any association between the use of tirofiban and any improvement in the epicardial and myocardial perfusion .
RESULTS	Major bleeding was observed in 6.1 % of patients receiving tirofiban and in 2.7 % of patients not receiving it ( relative risk , 2.22 ; 95 % confidence interval , 0.86 to 5.73 ; P = 0.14 ) .
CONCLUSIONS	This trial does not provide evidence to support the use of tirofiban after fibrinolysis to improve epicardial and myocardial perfusion .
CONCLUSIONS	Compared with bare-metal stent , paclitaxel-eluting stent significantly reduced late loss but appeared not to reduce in-segment binary restenosis .
BACKGROUND	URL : http://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00306228 .

###23176129
OBJECTIVE	To examine the effects of vitamin D and calcium on cognitive outcomes in elderly women .
METHODS	Post hoc analysis of a randomized double-blind placebo-controlled trial .
METHODS	Forty Women 's Health Initiative ( WHI ) clinical centers across the United States .
METHODS	Four thousand one hundred forty-three women aged 65 and older without probable dementia at baseline who participated in the WHI Calcium and Vitamin D Trial and the WHI Memory Study .
METHODS	Two thousand thirty-four women were randomized to receive 1,000 mg of calcium carbonate combined with 400 IU of vitamin D ( 3 ) ( treatment ) and 2,109 to placebo .
METHODS	Primary : classifications of probable dementia or mild cognitive impairment ( MCI ) based on a four-phase protocol that included central adjudication .
METHODS	Secondary : global cognitive function and individual cognitive subtests .
RESULTS	Mean age of participants was 71 .
RESULTS	During a mean follow-up of 7.8 years , 39 participants in the treatment group and 37 in the placebo group developed incident dementia ( hazard ratio ( HR ) = 1.11 , 95 % confidence interval ( CI ) = 0.71-1 .74 , P = .64 ) .
RESULTS	Likewise , 98 treatment participants and 108 placebo participants developed incident MCI ( HR = 0.95 , 95 % CI = 0.72-1 .25 , P = .72 ) .
RESULTS	There were no significant differences in incident dementia or MCI or in global or domain-specific cognitive function between groups .
CONCLUSIONS	There was no association between treatment assignment and incident cognitive impairment .
CONCLUSIONS	Further studies are needed to investigate the effects of vitamin D and calcium separately , on men , in other age and ethnic groups , and with other doses .

###16643541
OBJECTIVE	The purposes of this study were ( 1 ) to investigate the effect of different milk formulas on dental plaque pH after rinsing with these three categories , type of protein-based formulas ( milk-based , soy-based , protein hydrolysate ) , type of sugar ( only lactose , lactose and other sugars , only non-milk extrinsic sugars ) , and casein ratio ( high and low casein ) , and ( 2 ) to observe organic acids formed by different milk formulas .
METHODS	Baseline plaque pH and plaque pH at 2 , 5 , 10 , 15 , 20 , 25 , 30 , and 60 min after rinsing with milk formulas were recorded by a combination electrode in 14 healthy subjects .
METHODS	Deionized water and 10 % sucrose were used as a negative and positive control .
METHODS	The plaque sample was also analysed to identify and quantify the organic acids using a high-performance liquid chromatography .
METHODS	Parameters including minimum pH , maximum pH drop , and area under curve were compared by RMANOVA and paired t-test .
RESULTS	The minimum pH was not significantly different among different protein-based formulas , whereas , the maximum plaque pH drop of soy-based and milk-based formula was significantly higher than that produced by protein hydrolysate formula ( P = 0.022 and 0.03 , respectively ) .
RESULTS	Area under curve produced by soy-based and milk-based formulas was significantly larger than that created by protein hydrolysate formula ( P = 0.025 and < 0.001 , respectively ) .
RESULTS	Milk formulas containing only lactose caused significantly less plaque pH change in minimum pH ( P < 0.001 ) , maximum pH drop ( P = 0.003 ) , and area under curve ( P < 0.001 ) when compared with formulas containing lactose and other sugar but not with special formulas containing only non-milk extrinsic sugar .
RESULTS	Similarly , special formulas containing non-milk extrinsic sugar produced significantly lower minimum pH and smaller area under curve than formulas containing lactose and other sugar did ( P = 0.044 and 0.009 , respectively ) .
RESULTS	No different results were found between high and low casein follow-on formulas .
RESULTS	Lactic acid was produced more by rinsing with formulas containing lactose and other sugars than that produced by formulas containing only lactose .
CONCLUSIONS	This study suggests that milk formulas containing added other sugars tend to cause a decrease in plaque pH.

###21729315
BACKGROUND	A high quality decision requires that patients who meet clinical criteria for surgery are informed about the options ( including non-surgical alternatives ) and receive treatments that match their goals .
BACKGROUND	The aim of this study was to evaluate the psychometric properties and clinical sensibility of a patient self report instrument , to measure the quality of decisions about total joint replacement for knee or hip osteoarthritis .
METHODS	The performance of the Hip/Knee Osteoarthritis Decision Quality Instrument ( HK-DQI ) was evaluated in two samples : ( 1 ) a cross-sectional mail survey with 489 patients and 77 providers ( study 1 ) ; and ( 2 ) a randomized controlled trial of a patient decision aid with 138 osteoarthritis patients considering total joint replacement ( study 2 ) .
METHODS	The HK-DQI results in two scores .
METHODS	Knowledge items are summed to create a total knowledge score , and a set of goals and concerns are used in a logistic regression model to develop a concordance score .
METHODS	The concordance score measures the proportion of patients whose treatment matched their goals .
METHODS	Hypotheses related to acceptability , feasibility , reliability and validity of the knowledge and concordance scores were examined .
RESULTS	In study 1 , the HK-DQI was completed by 382 patients ( 79 % ) and 45 providers ( 58 % ) , and in study 2 by 127 patients ( 92 % ) , with low rates of missing data .
RESULTS	The DQI-knowledge score was reproducible ( ICC = 0.81 ) and demonstrated discriminant validity ( 68 % decision aid vs. 54 % control , and 78 % providers vs. 61 % patients ) and content validity .
RESULTS	The concordance score demonstrated predictive validity , as patients whose treatments were concordant with their goals had more confidence and less regret with their decision compared to those who did not .
CONCLUSIONS	The HK-DQI is feasible and acceptable to patients .
CONCLUSIONS	It can be used to assess whether patients with osteoarthritis are making informed decisions about surgery that are concordant with their goals .

###19502857
OBJECTIVE	This study attempts to determine whether stapled side-to-side anastomosis , compared with handsewn end-to-end anastomosis , results in decreased recurrence of Crohn 's disease following ileocolic resection .
METHODS	Patients with Crohn 's disease who underwent an ileocolic resection were randomized to side-to-side anastomosis or end-to-end anastomosis .
METHODS	Colonoscopy was performed at 12 months .
METHODS	The primary outcome was endoscopic recurrence , while the secondary outcome was symptomatic recurrence ( defined as symptoms attributable to Crohn 's disease and severe enough to warrant treatment , plus endoscopic disease recurrence ) .
RESULTS	One hundred and thirty-nine subjects were included in the efficacy analysis .
RESULTS	After a mean follow-up of 11.9 months , the endoscopic recurrence rate was 42.5 percent in the end-to-end anastomosis group , compared with 37.9 percent in the side-to-side anastomosis group ( -4.6 percent difference ; 95 percent confidence interval -21.0 to 11.9 percent ; P = 0.55 ) .
RESULTS	The symptomatic recurrence rate was 21.9 percent in the end-to-end anastomosis group , compared with 22.7 percent in the side-to-side anastomosis group ( +0.8 percent difference ; 95 percent confidence interval -13.2 to 15.3 percent ; P = 0.92 ) .
RESULTS	In multivariate logistic regression analysis , previous resections were predictive of a higher risk of both endoscopic ( odds ratio 1.78 ; 95 percent confidence interval 1.06 to 2.90 ; P = 0.028 ) and symptomatic ( odds ratio 2.0 ; 95 percent confidence interval 1.14 to 3.60 ; P = 0.0016 ) recurrence .
RESULTS	Compliance with postoperative maintenance therapy was predictive of a lower risk of symptomatic recurrence ( odds ratio 0.13 , 95 percent confidence interval 0.01 to 0.78 ; P = 0.021 ) .
CONCLUSIONS	Recurrence rates are similar whether end-to-end anastomosis or side-to-side anastomosis is performed .

###12586793
OBJECTIVE	Between February 1993 and September 1995 , 739 patients with metastatic breast cancer were entered on an Intergroup trial ( E1193 ) comparing doxorubicin ( 60 mg/m ( 2 ) ) , paclitaxel ( 175 mg/m ( 2 ) / 24 h ) , and the combination of doxorubicin and paclitaxel ( AT , 50 mg/m ( 2 ) and 150 mg/m ( 2 ) / 24 h , plus granulocyte colony-stimulating factor 5 mg/kg ) as first-line therapy .
OBJECTIVE	Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression .
METHODS	Patients were well balanced for on-study characteristics .
RESULTS	Responses ( complete response and partial response ) were seen in 36 % of doxorubicin , 34 % of paclitaxel , and 47 % of AT patients ( P = .84 for doxorubicin v paclitaxel , P = .007 for v AT , P = .004 for paclitaxel v AT ) .
RESULTS	Median time to treatment failure ( TTF ) is 5.8 , 6.0 , and 8.0 months for doxorubicin , paclitaxel , and AT , respectively ( P = .68 for doxorubicin v paclitaxel , P = .003 for doxorubicin v AT , P = .009 for paclitaxel v AT ) .
RESULTS	Median survivals are 18.9 months for patients taking doxorubicin , 22.2 months for patients taking paclitaxel , and 22.0 months for patients taking AT ( P = not significant ) .
RESULTS	Responses were seen in 20 % of patients crossing from doxorubicin -- > paclitaxel and 22 % of patients crossing from paclitaxel -- > doxorubicin ( P = not significant ) .
RESULTS	Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups .
CONCLUSIONS	( 1 ) doxorubicin and paclitaxel , in the doses used here , have equivalent activity ; ( 2 ) the combination of AT results in superior overall response rates and time to TTF ; and ( 3 ) despite these results , combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy .

###8694724
OBJECTIVE	To compare the effect of topical 0.5 % ketorolac tromethamine and 0.1 % diclofenac sodium on human corneal sensitivity and to assess the intensity of burning sensation at specific intervals after drop instillation .
METHODS	Double-masked parallel clinical study .
METHODS	Eleven women and 4 men ( 8 white , 4 Hispanic , 3 Asian ) , 22 to 60 years of age ( mean [ + / - SD ] , 34 + / - 10 years ) .
METHODS	Repeated instillation of either ketorolac and placebo or diclofenac and placebo at 5-minute intervals .
METHODS	Assessment of corneal sensitivity before instillation , immediately after instillation , and after termination of drop application ; and subjective evaluation of burning sensation by asking participants to rate burning on a scale ranging from 0 ( none ) to 3 ( severe ) after each drop application .
RESULTS	Both diclofenac ( P < .01 ) and ketorolac ( P < .01 ) decreased corneal sensitivity significantly , while the placebo had no measurable effect .
RESULTS	After administration of additional drops over time , the effect of diclofenac and ketorolac increased .
RESULTS	After termination of the drug instillation , corneal sensitivity returned to baseline significantly slower ( P < .01 ) in participants receiving diclofenac than in those receiving ketorolac .
RESULTS	Ketorolac ( P = .01 ) and diclofenac ( P < .05 ) were significantly more effective in whites than in nonwhites .
RESULTS	Mean burning sensation was mild , and there was no statistically significant difference between the 2 drugs on this measure ( P = .12 ) .
CONCLUSIONS	The decrease in corneal sensitivity in normal human corneas is more pronounced and longer lasting with diclofenac than with ketorolac .
CONCLUSIONS	Both drugs are well tolerated topically and may be useful for pain reduction after refractive corneal surgery .

###16283978
BACKGROUND	Because commercial minimally invasive harvesting equipments significantly increase operation costs , they are not always available in all clinics worldwide .
BACKGROUND	The aim of this study was to investigate whether minimally invasive saphenous vein harvesting using a laryngoscope can be applied efficiently and successfully .
METHODS	Thirty patients were prospectively randomized into two groups .
METHODS	One group underwent a minimally invasive technique using a laryngoscope ; the other , open saphenous vein harvest .
METHODS	A modified bridging technique , in which tissue retraction and illumination is achieved with a sterilized laryngoscope , was used for minimally invasive harvesting .
METHODS	Smooth muscle contractile and endothelial functions were tested in vitro using an organ chamber .
METHODS	Morphology was examined with light microscopy .
RESULTS	There was no statistically significant difference in harvest times or length of the vein harvested by either of the above mentioned techniques .
RESULTS	Total length of the incision in the minimally invasive group was significantly shorter than that in the open group .
RESULTS	In follow-ups , no significant complications occurred in either group .
RESULTS	Pain and leg edema were significantly less in the minimally invasive group compared to those of the open group .
RESULTS	There was no significant difference in response to acetylcholine and 80 mM KCl between veins taken with the laryngoscope compared to veins taken with the traditional open technique .
RESULTS	Similarly , histological data was unable to show any significant damage to the vessel wall .
CONCLUSIONS	Because the laryngoscopic saphenectomy does not harm the harvested graft , it can be applied , instead of other minimally invasive saphenous vein harvesting systems , with a zero cost , efficiently , successfully , and with satisfactory speed and significant reduction of postoperative leg pain and wound complications .

###19034108
BACKGROUND	Clinical benefits of thoracic epidural anesthesia ( TEA ) are partly ascribed to thoracic sympathetic block .
BACKGROUND	However , data regarding sympathetic activity during TEA are scarce and contradictory .
BACKGROUND	This prospective , randomized , double-blind study evaluated the segmental propagation of sympathetic block after low-concentration , high-volume TEA using digital thermography .
METHODS	Twenty-four patients were included in the study .
METHODS	Thoracic epidural catheters were placed at a median insertion level of T8-T9 .
METHODS	Patients were accommodated for 20 min to the room temperature of 23 degrees + / - 0.3 degrees C. Skin temperature was recorded by digital thermography .
METHODS	After baseline measurement of heart rate , arterial pressure , and core body and skin temperature , 10 ml saline ( control group ) or 10 ml bupivacaine , 0.25 % ( TEA group ) , respectively , was administered epidurally .
METHODS	Five minutes ( t5 ) and 20 min ( t20 ) after baseline measurements , hemodynamic parameters and core body temperature were again measured , and sensory block was identified by loss of cold-warm discrimination .
METHODS	In the thumb , the toe , and each thoracic dermatome , difference from baseline temperature was calculated at t5 and t20 .
METHODS	Data were analyzed by Mann-Whitney U test .
RESULTS	Baseline characteristics did not differ among groups .
RESULTS	Median spread of sensory block at t20 was T5-L5 .
RESULTS	At both t5 and t20 , skin temperature decreased more in the control group than in the TEA group in all thoracic dermatomes ( P < 0.05 ) .
RESULTS	Toe temperature increased in the TEA group compared with the control group ( P < 0.05 ) , whereas thumb temperature remained unchanged .
CONCLUSIONS	TEA with 10 ml bupivacaine , 0.25 % , induced thoracic and lumbar sympathetic block that precedes and exceeds sensory block .
CONCLUSIONS	Caudal limit of sympathetic block could not be demonstrated in this study .

###10746892
OBJECTIVE	This double-blind , randomized study was aimed at evaluating comparatively , in postmenopausal women , the activity of a standardized soy extract ( SOYSELECT ) and placebo when given alone or in combination with conjugated equine estrogens ( CEE ) on early climacteric symptoms .
OBJECTIVE	Lipid profile , pituitary hormones , osteocalcin and endothelin levels , and vaginal and endometrial parameters were also evaluated .
METHODS	Participants in the control group were given placebo , and participants in the treated group were given 400 mg/day of a standardized soy extract , corresponding to 50 mg/daily of isoflavones .
METHODS	After 6 weeks of treatment , CEE was also then given to each participant at a dose of 0.625 mg/day for 4 weeks .
METHODS	At the end of this period , soy and placebo treatment were suspended , and , until the end of the study ( week 12 ) , participants were administered 10 mg/day of medroxyprogesterone acetate in association with CEE ( 0.625 mg/day ) .
RESULTS	When compared with pretreatment data , on week 6 of the study , a significant ( p < 0.01 ) reduction in the mean number of hot flushes per week was observed in participants who were receiving the standardized soy extract , whereas a more marked relief was observed in both soy and placebo groups during CEE administration .
RESULTS	Concurrently , the severity of hot flushes , assessed by means of the Greene climacteric scale , was also reduced in the soy group participants ( p < 0.001 , by paired t-test ) .
RESULTS	No soy-related changes were observed on vaginal cytology , endometrial thickness , uterine artery pulsatility index , or metabolic and hormonal parameters tested .
RESULTS	Finally , CEE-related changes on genital tract , uterine vascular compartment , and pituitary hormones were not modified by soy treatment .
CONCLUSIONS	SOYSELECT may be a safe and efficacious therapy for relief of hot flushes in women who refuse or have contraindications for hormone replacement therapy .

###24278929
OBJECTIVE	The aim of this study was to compare clinical outcomes and stability following immediate loading of two types of tapered implants in the partially edentulous posterior maxilla and mandible .
METHODS	A randomized controlled trial with 1 year of follow-up was performed on participants missing two consecutive teeth in a posterior quadrant with tapered implants with a hybrid textured surface .
METHODS	Group 1 received Osstem TSIII HA implants , and group 2 received Zimmer TSV implants .
METHODS	Group 1 implants were 4.5 or 5.0 mm in diameter , and group 2 implants were 4.7 mm in diameter ; all implants were 10 mm long .
METHODS	Subjects received provisional restorations within 48 hours .
METHODS	Definitive restorations were provided 3 months ( mandible ) or 6 months ( maxilla ) later .
METHODS	Outcome measures were survival and success rates , marginal bone level change , implant stability quotient , and peri-implant soft tissue indices .
RESULTS	Fifty participants completed the trial ( group 1 : 52 implants in 26 patients ; group 2 : 48 implants in 24 patients ) .
RESULTS	The success rates were similar -- 98.1 % in group 1 and 97.9 % in group 2 -- at 12 months after immediate loading , but marginal bone loss was significantly different according to the implant design .
RESULTS	Implant stability increased significantly in both arches .
RESULTS	There were no significant differences in soft tissue indices between implant systems .
CONCLUSIONS	If high primary stability is acquired , tapered implants with hybrid textured surfaces are predictable for immediate loading in the posterior maxilla and mandible .
CONCLUSIONS	In spite of the influence of implant design on marginal bone loss , all tapered implants showed successful clinical outcomes and stability in immediate loading .

###23597719
BACKGROUND	RV3 is a human neonatal rotavirus strain ( G3P [ 6 ] ) that has been associated with asymptomatic neonatal infection and replicates well in the infant gut .
BACKGROUND	RV3-BB rotavirus vaccine has been developed as a rotavirus vaccine candidate for administration at birth .
METHODS	A single-centre , double-blind , randomised placebo-controlled Phase I study evaluated the safety and tolerability of a single oral dose of the second generation RV3-BB rotavirus vaccine ( 8.310 ( 6 ) FFU/mL ) in 20 adults , 20 children and 20 infants ( 10 vaccine and 10 placebo per age cohort ) .
METHODS	Vaccine take was defined as seroconversion ( a 3-fold increase in serum anti-rotavirus IgA or serum neutralising antibody ( SNA ) from baseline at day 28 post-dose ) or evidence of RV3-BB viral replication in the faeces by RT-PCR analysis 3-6 days post-vaccination .
METHODS	RV3-BB presence was confirmed by sequence analysis .
RESULTS	The RV3-BB vaccine was well tolerated in all participants , with no pattern of adverse events shown to be associated with the study vaccine .
RESULTS	In the infant cohort , vaccine take was demonstrated in 8/9 infants following a single dose of vaccine compared with 2/7 placebo recipients .
RESULTS	In the infant vaccine group , 5/9 infants exhibited either IgA or SNA seroconversion and 7/9 infants had evidence of RV3-BB replication on days 3-6 , compared with 2/7 infants who seroconverted and 0/10 infants with evidence of replication in the placebo group .
RESULTS	Two infants in the placebo group had serological evidence of a rotavirus infection within the 28-day study period : one demonstrated an IgA and the other an SNA response , with wild-type virus replication detected in another infant .
CONCLUSIONS	A single dose of RV3-BB rotavirus vaccine was well tolerated in adults , children and infants .
CONCLUSIONS	Most infants ( 8/9 ) who received RV3-BB demonstrated vaccine take following a single dose .
CONCLUSIONS	These data support progression of RV3-BB to Phase II immunogenicity and efficacy trials .

###24888810
OBJECTIVE	Figitumumab ( CP-751 ,871 ) , a fully human immunoglobulin G2 monoclonal antibody , inhibits the insulin-like growth factor 1 receptor ( IGF-1R ) .
OBJECTIVE	Our multicenter , randomized , phase III study compared figitumumab plus chemotherapy with chemotherapy alone as first-line treatment in patients with advanced non-small-cell lung cancer ( NSCLC ) .
METHODS	Patients with stage IIIB/IV or recurrent NSCLC disease with nonadenocarcinoma histology received open-label figitumumab ( 20 mg/kg ) plus paclitaxel ( 200 mg/m ( 2 ) ) and carboplatin ( area under the concentration-time curve , 6 mg min/mL ) or paclitaxel and carboplatin alone once every 3 weeks for up to six cycles .
METHODS	The primary end point was overall survival ( OS ) .
RESULTS	Of 681 randomly assigned patients , 671 received treatment .
RESULTS	The study was closed early by an independent Data Safety Monitoring Committee because of futility and an increased incidence of serious adverse events ( SAEs ) and treatment-related deaths with figitumumab .
RESULTS	Median OS was 8.6 months for figitumumab plus chemotherapy and 9.8 months for chemotherapy alone ( hazard ratio [ HR ] , 1.18 ; 95 % CI , 0.99 to 1.40 ; P = .06 ) ; median progression-free survival was 4.7 months ( 95 % CI , 4.2 to 5.4 ) and 4.6 months ( 95 % CI , 4.2 to 5.4 ) , respectively ( HR , 1.10 ; P = .27 ) ; the objective response rates were 33 % and 35 % , respectively .
RESULTS	The respective rates of all-causality SAEs were 66 % and 51 % ; P < .01 ) .
RESULTS	Treatment-related grade 5 adverse events were also more common with figitumumab ( 5 % v 1 % ; P < .01 ) .
CONCLUSIONS	Adding figitumumab to standard chemotherapy failed to increase OS in patients with advanced nonadenocarcinoma NSCLC .
CONCLUSIONS	Further clinical development of figitumumab is not being pursued .

###16131580
BACKGROUND	Subclinical hyperthyroidism has been reported to affect systolic and diastolic cardiac function .
BACKGROUND	However , the reversibility of these effects is not well established .
OBJECTIVE	Our objective was to investigate the presence and reversibility of cardiac abnormalities in patients with long-term exogenous subclinical hyperthyroidism .
METHODS	We conducted a prospective , single-blinded , placebo-controlled randomized trial of 6 months duration with two parallel groups .
METHODS	The study occurred at the Leiden University Medical Center , a tertiary referral center for thyroid carcinoma .
METHODS	As a model for subclinical hyperthyroidism , 25 patients with a history of differentiated thyroid carcinoma with more than 10 yr of TSH suppressive therapy with L-T4 were studied .
METHODS	L-T4 dose was replaced by study medication containing L-T4 or placebo .
METHODS	Medication was titrated in a single-blinded fashion to establish continuation of TSH suppression ( low-TSH group ) or euthyroidism ( euthyroid group ) .
METHODS	We assessed serum levels of free T4 and TSH and used echo Doppler cardiography including tissue Doppler to establish left ventricular ( LV ) dimensions and function as well as diastolic function .
METHODS	Baseline echocardiography data were compared with 24 controls .
RESULTS	There were no differences in baseline cardiac parameters and TSH levels between the two groups .
RESULTS	Although mean LV mass index was increased as compared with 24 controls , only four patients had LV hypertrophy at baseline .
RESULTS	This was not improved by restoration of euthyroidism .
RESULTS	At baseline , diastolic function was impaired in all patients as indicated by abnormal values for the peak flow of the early filling phase ( E , 55.3 + / - 9.5 mm/sec ) , the ratio of E and the peak flow of the atrial filling phase ( E/A ratio , 0.87 + / - 0.13 ) , the early diastolic velocity obtained by tissue Doppler ( E ' , 5.7 + / - 1.3 cm/sec ) , and the peak atrial filling velocity obtained by tissue Doppler ( A ' , 6.8 + / - 1.4 cm/sec ) , prolonged E deceleration time ( 234 + / - 34 msec ) , and isovolumetric relaxation time ( 121 + / - 15 msec ) .
RESULTS	After 6 months , significant improvements were observed in the euthyroid group in the E/A ratio ( +41 % ; P < 0.001 ) , E deceleration time ( -18 % ; P = 0.006 ) , isovolumetric relaxation time ( -25 % ; P < 0.001 ) , E ' ( +31 % ; P < 0.001 ) , and the E ' / A ' ratio ( +40 % ; P < 0.001 ) .
CONCLUSIONS	We conclude that prolonged subclinical hyperthyroidism is accompanied by diastolic dysfunction that is at least partly reversible after restoration of euthyroidism .
CONCLUSIONS	Because isolated diastolic dysfunction may be associated with increased mortality , this finding is of clinical significance .

###16552194
BACKGROUND	Intestinal adhesion following abdominal surgery is a significant sequela to abdominal surgery .
BACKGROUND	Intergel is a hyaluronate-based gel that reduces the incidence of postoperative adhesions when added to the peritoneal cavity before closure in gynecologic surgery .
BACKGROUND	This is a randomized controlled trial evaluating the efficacy and safety of Intergel in colorectal resections .
BACKGROUND	Although the study aimed to recruit 200 patients based on power analysis , recruitment was suspended because of the high morbidity in the treatment group .
METHODS	A total of 32 patients were randomized to either Intergel treatment ( treatment group ) or no treatment ( control group ) following open abdominal surgery .
METHODS	Primary endpoints included the incidence of adhesive obstruction , the need for subsequent adhesiolysis , and the incidence of wound and anastomotic complications .
METHODS	A secondary endpoint involved quality-of-life assessment .
RESULTS	Seventeen patients were randomized to the treatment group and 15 to the control group .
RESULTS	All patients , except 1 in the treatment group , underwent resection and anastomosis of the colon or rectum for benign or malignant disease .
RESULTS	A significant difference was observed in the number of patients with postoperative morbidities between the 2 groups ( 65 % treatment group versus 27 % control group , P = 0.031 ) .
RESULTS	There was a high rate of anastomotic dehiscence ( 5 treatment group versus 1 control group , P = 0.178 ) and prolonged postoperative ileus ( 10 treatment group versus 2 control group , P = 0.011 ) observed in treatment group .
RESULTS	One case of peritonitis occurred in the treatment group in the presence of an intact anastomosis .
RESULTS	Wound complications were more common in treatment group but failed to reach statistical significance .
CONCLUSIONS	The use of Intergel in abdominal surgery where the gastrointestinal tract is opened leads to unacceptably high rates of postoperative complications .

###21358538
BACKGROUND	In a cluster-randomized trial including 1832 hypertensive patients , all 126 general practitioners ( GPs ) in the intervention group ( IG ) used an oscillometric device that was provided for blood pressure ( BP ) measurements .
BACKGROUND	Of the 131 GPs of the control group ( CG ) , 24.6 % used an oscillometric device ( OCG ) , and 75.4 % used a manual device ( MCG ) .
BACKGROUND	At baseline , patients in the IG and CG were comparable for all clinical and biological characteristics , except BP , which was higher in the IG ( 146/84 vs. 139/81 mmHg ; P < 0.001 ) .
BACKGROUND	The purpose of this ancillary study was to assess whether these differences in BP values were related to the end-digit preference ( EDP ) , selection bias , or both .
METHODS	Analysis was carried out and comparison was made of 3629 BP measurements by 257 GPs .
METHODS	Statistical analysis used hierarchical mixed-effect models with random physician effect and fixed-effect covariables .
RESULTS	The frequencies of 0 end digit were 16.7 % in the IG , 32.4 % in the OCG and 68.8 % in the MCG for systolic BP ( SBP ; P < 0.001 for all comparisons ) , and respectively 17.7 , 38.1 , and 74.1 % for diastolic BP ( DBP ; P = 0.017 for all comparisons ) .
RESULTS	SBP was higher in the IG than in OCG ( +3.65 mmHg , P = 0.017 ) .
RESULTS	The same trend was observed for DBP , though not significant ( +1.50 mmHg , P = 0.20 ) .
RESULTS	The EDP in the CG led to a mean underevaluation of 2.4 mmHg ( P < 0.0005 ) of SBP and DBP .
CONCLUSIONS	The observed differences in BP between the groups are partly explained by the impact of EDP .
CONCLUSIONS	Compared with the manual , oscillometric measurement may reduce EDP .

###21936930
BACKGROUND	Amyotrophic lateral sclerosis is a rapidly progressive neurodegenerative disorder characterised by loss of motor neurons leading to severe weakness and death from respiratory failure within 3-5 years .
BACKGROUND	Riluzole prolongs survival in ALS .
BACKGROUND	A published report has suggested a dramatic effect of lithium carbonate on survival .
BACKGROUND	44 patients were studied , with 16 randomly selected to take LiCO3 and riluzole and 28 allocated to take riluzole alone .
BACKGROUND	In the group treated with lithium , no patients had died ( i.e. , 100 % survival ) at the end of the study ( 15 months from entry ) , compared to 71 % surviving in the riluzole-only group .
BACKGROUND	Although the trial can be criticised on several grounds , there is a substantial rationale from other laboratory studies that lithium is worth investigating therapeutically in amyotrophic lateral sclerosis .
METHODS	LiCALS is a multi-centre double-blind randomised parallel group controlled trial of the efficacy , safety , and tolerability of lithium carbonate ( LiCO3 ) at doses to achieve stable ` therapeutic ' plasma levels ( 0.4-0 .8 mmol/L ) , plus standard treatment , versus matched placebo plus standard treatment , in patients with amyotrophic lateral sclerosis .
METHODS	The study will be based in the UK , in partnership with the MND Association and DeNDRoN ( the Dementias and Neurodegnerative Diseases Clinical Research Network ) .
METHODS	220 patients will be recruited .
METHODS	All patients will be on the standard treatment for ALS of riluzole 100 mg daily .
METHODS	The primary outcome measure will be death from any cause at 18 months defined from the date of randomisation .
METHODS	Secondary outcome measures will be changes in three functional rating scales , the ALS Functional Rating Scale-Revised , The EuroQOL ( EQ-5D ) , and the Hospital Anxiety and Depression Scale.Eligible patients will have El Escorial Possible , Laboratory-supported Probable , Probable or Definite amyotrophic lateral sclerosis with disease duration between 6 months and 36 months ( inclusive ) , vital capacity 60 % of predicted within 1 month prior to randomisation and age at least18 years .
CONCLUSIONS	Patient recruitment began in June 2009 and the last patient is expected to complete the trial protocol in November 2011 .
BACKGROUND	Current controlled trials ISRCTN83178718 .

###1497039
OBJECTIVE	Our objective was to compare the safety and efficacy of two accepted oxytocin induction protocols that differ in oxytocin dose increments .
METHODS	At the Carolinas Medical Center in Charlotte , North Carolina , 151 women with indications for induction of labor were prospectively randomized into one of two oxytocin induction protocols .
METHODS	Safety and efficacy of the two protocols were analyzed with two-tailed t tests and chi 2 .
RESULTS	Time from induction to establishment of a regular labor pattern was significantly shorter in the experimental group compared with the traditional group ( p = 0.03 ) .
RESULTS	However , no significant difference was seen from onset of induction to time of delivery .
RESULTS	Incidences of hyperstimulation were not significantly different between the two protocols , but there was a trend toward a higher incidence of fetal heart rate changes in the experimental group ( p = 0.08 ) .
CONCLUSIONS	These data suggest that induction with larger dose increments will shorten time to adequate labor without an associated increase in uterine hyperstimulation or poor neonatal outcome .
CONCLUSIONS	The differences in heart rate changes are concerning and merit further investigation .
CONCLUSIONS	If confirmed by further studies , an increased risk of cord compression could outweigh the benefit of a faster onset of contractions .

###18278988
OBJECTIVE	This study examined the characteristics and outcomes of patients with major depressive disorder ( MDD ) , with or without atypical features , who were treated with acute bilateral electroconvulsive therapy ( ECT ) .
METHODS	Analyses were conducted with 489 patients who met DSM-IV criteria for MDD .
METHODS	Subjects were identified as typical or atypical on the basis of the Structured Clinical Interview for DSM-IV obtained at baseline prior to ECT .
METHODS	Depression symptom severity was measured by the 24-item Hamilton Rating Scale for Depression ( HAM-D ( 24 ) ) and the 30-item Inventory of Depressive Symptomatology-Self-Report ( IDS-SR ( 30 ) ) .
METHODS	Remission was defined as at least a 60 % decrease from baseline in HAM-D ( 24 ) score and a total score of 10 or below on the last 2 consecutive HAM-D ( 24 ) ratings .
METHODS	The randomized controlled trial was performed from 1997 to 2004 .
RESULTS	The typical ( N = 453 ) and atypical ( N = 36 ) groups differed in several sociodemographic and clinical variables including gender ( p = .0071 ) , age ( p = .0005 ) , treatment resistance ( p = .0014 ) , and age at first illness onset ( p < .0001 ) and onset of current episode ( p = .0008 ) .
RESULTS	Following an acute course of bilateral ECT , a considerable portion of both the typical ( 67.1 % ) and the atypical ( 80.6 % ) groups reached remission .
RESULTS	The atypical group was 2.6 ( 95 % CI = 1.1 to 6.2 ) times more likely to remit than the typical group after adjustment for age , psychosis , gender , clinical site , and depression severity based on the HAM-D ( 24 ) .
CONCLUSIONS	Acute ECT is an efficacious treatment for depressed patients with typical or atypical symptom features .
BACKGROUND	clinicaltrials.gov Identifier : NCT00000375 .

###17389292
BACKGROUND	Interleukin 2 ( IL-2 ) administration increases CD4 counts in persons with higher counts .
BACKGROUND	This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy ( HAART ) .
METHODS	Two hundred four patients with CD4 T-cell counts from 50/microL to 350/microL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen .
METHODS	Virologic responders ( < or = 5000 copies/mL ) at 12 weeks were randomized to open-label continuous-infusion IL-2 ( IV IL-2 ) , subcutaneous IL-2 ( SC IL-2 ) , or HAART alone .
METHODS	Thirty were not randomized and 15 enrolled in a substudy , leaving 159 for analysis .
METHODS	Subjects continued HAART alone for 72 weeks ( n = 52 ) or with IV IL-2 ( n = 53 ) or SC IL-2 ( n = 54 ) for 5 days every 8 weeks .
METHODS	The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/microL or by 25 % .
RESULTS	Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts .
RESULTS	At week 84 , median increases were 459/microL , 312/microL , and 102/microL .
RESULTS	Increases of greater than 50 % at week 60 ( primary end point ) were achieved in 39 patients ( 81 % ) and 32 ( 67 % ) in the IV and SC IL-2 arms , respectively , compared with 13 ( 29 % ) in the HAART arm ( P < .001 for both ) .
RESULTS	Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels .
RESULTS	There were fewer new AIDS-defining events in the IV ( P = .006 ) and SC ( P = .03 ) IL-2 groups than in the HAART group ( 0 , 1 , and 7 , respectively ) .
RESULTS	Drug-related adverse events were more frequent with IL-2 treatment .
CONCLUSIONS	Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection , without loss of virologic control .

###15248204
OBJECTIVE	To evaluate the long-term frequency of disease remissions and the progression of joint damage in patients with early rheumatoid arthritis ( RA ) who were initially randomized to 2 years of treatment with either a combination of 3 disease-modifying antirheumatic drugs ( DMARDs ) or a single DMARD .
METHODS	In this multicenter prospective followup study , a cohort of 195 patients with early , clinically active RA was randomly assigned to treatment with a combination of methotrexate , sulfasalazine , hydroxychloroquine , and prednisolone or with a single DMARD ( initially , sulfasalazine ) with or without prednisolone .
METHODS	After 2 years , the DMARD and prednisolone treatments became unrestricted , but were still targeted toward remission .
METHODS	The long-term effectiveness was assessed by recording the frequency of remissions and the extent of joint damage seen on radiographs of the hands and feet obtained annually up to 5 years .
METHODS	Radiographs were assessed by the Larsen score .
RESULTS	A total of 160 patients ( 78 in the combination group and 82 in the single group ) completed the 5-year extension study .
RESULTS	At 2 years , 40 % of the patients in the combination-DMARD group and 18 % in the single-DMARD group had achieved remission ( P < 0.009 ) .
RESULTS	At 5 years , the corresponding percentages were 28 % and 22 % ( P not significant ) .
RESULTS	The median Larsen radiologic damage scores at baseline , 2 years , and 5 years in the combination-DMARD and single-DMARD groups were 0 and 2 ( P = 0.50 ) , 4 and 12 ( P = 0.005 ) , and 11 and 24 ( P = 0.001 ) , respectively .
CONCLUSIONS	Aggressive initial treatment of early RA with the combination of 3 DMARDs for the first 2 years limits the peripheral joint damage for at least 5 years .
CONCLUSIONS	Our results confirm the earlier concept that triple therapy with combinations of DMARDs contributes to an improved long-term radiologic outcome in patients with early and clinically active RA .

###9554633
BACKGROUND	The recent consensus reports on asthma management emphasize the importance of using peak flowmeters to accurately assess the degree of airflow obstruction .
BACKGROUND	However , the optimal way to use those devices has not yet been determined .
OBJECTIVE	To assess compliance with peak expiratory flow ( PEF ) measurements in the long-term management of asthma , and identify the characteristics of patients with poor compliance .
METHODS	Asthma clinics from three tertiary-care hospitals .
METHODS	A descriptive and prospective study of 1-year duration .
METHODS	Twenty-six patients with moderate to severe asthma taking part in an asthma education program .
METHODS	Patients were asked to measure morning and evening PEF using an electronic peak flowmeter with a 3-month memory ; they were unaware that PEF values were being recorded by this device .
RESULTS	Compliance with PEF measurements was relatively good during the first month ( 63 % of the measurements done ) but even with regular reinforcement , fell to 50 % at 6 months and to 33 % at 12 months .
RESULTS	Right from the beginning , 8 of 26 subjects ( 30 % ) never or almost never ( < 5 % of the readings done ) measured PEF , with seven of these subjects writing fabricated results in their diaries most of the time .
RESULTS	At 12 months , 60 % of the subjects were measuring PEF < 25 % of the time , and most of them continued writing fabricated PEF values in their diaries .
RESULTS	None of the subjects ' characteristics helped us to identify those who had poor compliance with these measurements .
CONCLUSIONS	While short-term compliance with PEF measurements is fairly good , most patients with moderate to severe asthma are not interested in measuring PEF twice daily over a prolonged period .
CONCLUSIONS	In the current management of asthma , PEF measurement devices can be suggested to those showing a strong personal interest in using them , but should be limited to short periods of time .
CONCLUSIONS	Furthermore , this study outlines the usefulness of electronic peak flowmeters when doing clinical research where PEF improvement is an important outcome .

###22841455
BACKGROUND	We investigated ( 1 ) the effects of acute alcohol on inhibition of alcohol-related versus neutral cues , ( 2 ) the effects of drinking status on inhibition of alcohol-related versus neutral cues , and ( 3 ) the similarity of any effects of alcohol or drinking status across two different cue types ( lexical versus pictorial ) .
METHODS	Participants received 0.0 g/kg , 0.4 g/kg or 0.6 g/kg of alcohol in a between-subjects design .
METHODS	Healthy , heavy and light social alcohol users ( n = 96 ) completed both lexical and pictorial cue versions of an alcohol-shifting task .
METHODS	Participants were instructed to respond to target stimuli by pressing the spacebar , but to ignore distracter stimuli .
METHODS	Errors towards distracter stimuli were analysed using a series of mixed-model ANOVAs , with between-subjects factors of challenge and drinking status and within-subjects factors of distracter type ( alcohol , neutral ) and block ( shift , non-shift ) .
RESULTS	Lexical commission error data indicated a main effect of distracter ( F [ 1,90 ] = 43.25 , p < 0.001 , ( 2 ) = 0.33 ) , which was qualified by a marginal interaction with challenge condition ( F [ 2,90 ] = 2.77 , p = 0.068 , ( 2 ) = 0.06 ) .
RESULTS	Following an acute high dose of alcohol participants made more errors towards alcohol distracters .
RESULTS	Pictorial commission error data indicated a significant main effect of distracter ( F [ 1,90 ] = 67.40 , p < 0.001 , ( 2 ) = 0.43 ) , such that all participants made more errors towards neutral image distracters versus alcohol distracter images .
CONCLUSIONS	Our results reveal acute alcohol 's impairment of inhibitory control may be enhanced when a response towards alcohol-related lexical stimuli is required to be withheld .

###23896377
BACKGROUND	The prognosis of patients with anaplastic oligodendrogliomas ( AOD ) and oligoastrocytomas ( AOA ) is variable .
BACKGROUND	Biomarkers might be helpful to identify more homogeneous disease subtypes and improve therapeutic index .
BACKGROUND	The aim of this study is to develop new clinical , pathological and molecular prognostic models for locally diagnosed anaplastic gliomas with oligodendroglial features ( AOD or AOA ) .
METHODS	Data from 368 patients with AOD or AOA recruited in The European Organisation for Research and Treatment of Cancer ( EORTC ) trial 26951 on adjuvant PCV ( Procarbazine , CCNU , Vincristine ) chemotherapy in anaplastic oligodendroglial tumours were used to develop multifactor models to predict progression free survival ( PFS ) and overall survival ( OS ) .
METHODS	Different models were compared by their percentage of explained variation ( PEV ) .
METHODS	Prognostic calculators were derived from these new models .
RESULTS	Treatment ( for PFS only ) , younger age , confirmed absence of residual tumour on imaging , frontal location , good World Health Organisation ( WHO ) performance status , absence of endothelial abnormalities and/or necrosis , 1p/19q codeletion and Isocitrate dehydrogenase 1 ( IDH1 ) mutation were independent factors that predicted better PFS and OS .
CONCLUSIONS	We identified important prognostic factors for AOD and AOA and showed that molecular markers added a major contribution to clinical and pathological factors in explaining PFS and OS .
CONCLUSIONS	With a positive predictive value of 92 % for PFS and 94 % for OS , our models allow physicians to precisely identify high risk patients and aid in making therapeutic decisions .

###22914470
OBJECTIVE	To compare surgical outcome and quality of life of robot-assisted laparoscopic hysterectomy with conventional laparoscopic hysterectomy .
METHODS	For this controlled clinical trial , patients with benign indications for hysterectomy were randomized to receive either a robotic ( robotic group ) or conventional laparoscopic hysterectomy ( conventional group ) .
METHODS	The primary end point was total operating time ; secondary end points were perioperative outcome , blood loss , and the change in quality of life .
RESULTS	Ninety-five patients out of 100 randomized patients completed the study .
RESULTS	Patient age , body mass index , and uterus weight showed no significant differences between both groups .
RESULTS	All results are given as mean ( standard deviation ; median ) .
RESULTS	Total operating time for the robotic group was significantly higher with 106 ( 29 ; 103 ) compared with 75 ( 21 ; 74 ) ( conventional group ) minutes .
RESULTS	Blood loss , complications , analgesics use , and return to activity for both groups were comparable .
RESULTS	The change in preoperative to postoperative quality-of-life index ( quality of life measured on a linear scale from 0 to 100 ) was significantly higher in the robotic group , with 13 ( 10 ; 13 ) compared with 5 ( 14 ; 5 ) ( conventional group ) .
CONCLUSIONS	Robot-assisted laparoscopic hysterectomy and conventional laparoscopy compare well in most surgical aspects , but the robotic procedure is associated with longer operating times .
CONCLUSIONS	Postoperative quality-of-life index was better ; however , long-term , there was no difference .
CONCLUSIONS	However , subjective postoperative parameters such as analgesic use and return to activity showed no significant difference between both groups .

###19701509
OBJECTIVE	To evaluate the effects of gaseous ozone application on enamel and dentin bond strength produced by two self-etching adhesive systems .
METHODS	The shear bond strength test was conducted to assess adhesion on enamel ( protocol 1 ) , while the microtensile bond strength test was performed on dentin ( protocol 2 ) .
METHODS	Protocol 1 : 96 bovine incisors were randomly divided into 4 groups , and enamel surfaces were bonded in accordance with the following treatments : ( 1E ) ozone + Clearfil Protect Bond ; ( 2E ) Clearfil Protect Bond ( control ) ; ( 3E ) ozone + Xeno III ; ( 4E ) Xeno III ( control ) .
METHODS	Ozone gas was applied for 80 s. Shear bond strength was measured with a universal testing machine .
METHODS	Protocol 2 : 40 noncarious human molars were selected .
METHODS	Middle/deep dentin was exposed and bonded in accordance with the following treatments : ( 1D ) ozone + Clearfil Protect Bond ; ( 2D ) Clearfil Protect Bond ( control ) ; ( 3D ) ozone + Xeno III ( 4D ) Xeno III ( control ) .
METHODS	Four-mm-thick buildups were built on the adhesives , then specimens were sectioned in accordance with the nontrimming technique .
METHODS	Specimens were stressed until failure occurred , and failure modes were analyzed .
METHODS	Shear bond and microtensile bond strength data were analyzed using two-way ANOVA and Tukey 's post-hoc test .
RESULTS	No statistical differences were found between ozone treated specimens and controls , neither on enamel nor on dentin irrespective of the tested adhesive .
RESULTS	Clearfil Protect Bond showed higher bond strength to enamel than Xeno III , irrespective of the ozone treatment ( p < 0.05 ) .
CONCLUSIONS	The use of ozone gas to disinfect the cavity before placing a restoration had no influence on immediate enamel and dentin bond strength .

###20470675
OBJECTIVE	The aim of the study was to perform a prospective blinded trial to compare the improvement of midface acne rosacea using 532 nm laser therapy with and without a retinaldehyde-based topical application .
METHODS	A private clinic and surgicentre specializing in facial plastic surgery .
METHODS	A prospective randomized blinded clinical trial .
METHODS	Fourteen patients with type 1 erythematotelangiectatic acne rosacea were enrolled in the study .
METHODS	The side of the face to be treated was chosen randomly .
METHODS	The opposite side of the face served as the control .
METHODS	Patients underwent six treatments with the 532 nm laser , with four sets of photodocumentation over a period of 3 months .
METHODS	Following each treatment , patients were asked to rate their degree of improvement based on a 5-point improvement scale .
METHODS	A final assessment was performed by five separate blinded evaluators .
METHODS	Final photographic evaluation to assess ( 1 ) reduction in overall redness , ( 2 ) reduction in visible telangiectasia , ( 3 ) difference between left and right sides of the face , and ( 4 ) degree of overall skin texture improvement .
RESULTS	Three men and eight women completed the study .
RESULTS	Six right hemifaces and five left hemifaces were treated .
RESULTS	One hundred percent of patients noted a mild to moderate improvement in all signs of type 1 acne rosacea , including overall redness of the face , telangiectasia , and skin texture .
RESULTS	The blinded evaluators were able to note a difference between the treated and untreated sides 47 % of the time .
CONCLUSIONS	The 532 nm laser combined with the topical retinaldehyde improved overall redness , telangiectasia , and skin texture in acne rosacea patients .
CONCLUSIONS	The degree of improvement was greater when compared to using the laser alone as the sole treatment modality .

###20139154
BACKGROUND	The objective of the study was to evaluate completion rates and toxic effects of an i.p. chemotherapy regimen in a cross-section of nonselected patients with ovarian cancer ( OC ) .
METHODS	All patients with stage IIIC OC consecutively operated at our institution from January 2006 to December 2007 were prospectively collected and analyzed .
RESULTS	Eighty-nine patients with stage IIIC OC optimally debulked were evaluated for this study .
RESULTS	An i.p. port was primarily placed in 53 of 89 ( 60 % ) , and i.p. chemotherapy was recommended in 55 patients .
RESULTS	Reasons for not recommending i.p. chemotherapy in patients optimally debulked included postoperative complications ( n = 7 : 8 % ) , poor nutritional/functional status ( n = 5 : 6 % ) , and extensive surgery including bowel resection ( n = 9 : 10 % ) .
RESULTS	Thirty-three patients ( 33/55 : 60 % ) recommended to receive i.p. chemotherapy-initiated i.p. treatment .
RESULTS	Fifty-two percent of those beginning i.p. therapy ( 17/33 ) received three or more cycles with 36 % ( 12/33 ) successfully completing six cycles .
RESULTS	Reasons for discontinuation included grade 3-4 nephrotoxicity in 3 of 21 ( 14 % ) , febrile neutropenia/sepsis in 3 of 21 ( 14 % ) , port infection or malfunction in 8 of 21 ( 38 % ) .
CONCLUSIONS	The i.p. chemotherapy regimen used in a consecutive cohort of patients carries could be completed in only a small percentage of patients .
CONCLUSIONS	Less toxic regimens with higher acceptability should be considered .

###17506593
OBJECTIVE	In addition to reducing blood pressure , antihypertensive drugs should modify other atherosclerotic risk factors .
OBJECTIVE	One such risk factor is the prothrombotic state , which is characterised mainly by increased fibrinogen and plasminogen activator inhibitor-1 levels and abnormalities in platelet function .
OBJECTIVE	Platelet activity and aggregation potential can be estimated by measuring mean platelet volume ( MPV ) .
OBJECTIVE	Serotonin plays a role in vasospasm and increased platelet aggregation capacity , and has been shown to increase MPV in vitro .
OBJECTIVE	However , serotonin levels and MPV have not been studied in the metabolic syndrome .
OBJECTIVE	We evaluated mean platelet volume ( MPV ) in patients with the metabolic syndrome , and compared the effects of doxazosin and amlodipine on MPV and serum serotonin level in patients with this condition .
METHODS	Thirty-eight patients who met the Adult Treatment Panel III criteria for the metabolic syndrome and 20 healthy controls were included in the study .
METHODS	Patients were randomised into two groups to receive doxazosin 4 mg/day ( n = 20 ) or amlodipine 10 mg/day ( n = 18 ) .
METHODS	Patients ' MPV , serum serotonin , insulin , insulin sensitivity , fasting blood glucose and lipid profiles were measured at baseline and after 8 weeks .
RESULTS	Patients with the metabolic syndrome had a significantly higher MPV compared with the control group .
RESULTS	MPV was significantly decreased in the doxazosin-treated group ( from 6.9 + / - 1.0 fL at baseline to 6.1 + / - 1.1 fL after treatment ; p = 0.02 ) but not in the amlodipine-treated group ( 6.8 + / - 0.9 fL at baseline vs 6.9 + / - 1.0 fL after treatment ; p = 0.9 ) .
RESULTS	Fasting blood glucose and total cholesterol were also significantly decreased compared with baseline in the doxazosin group .
RESULTS	In the amlodipine group , there was a significant increase in serum serotonin levels and a decrease in serum insulin and improved insulin sensitivity .
CONCLUSIONS	In patients with the metabolic syndrome , doxazosin treatment not only decreases platelet activity , as measured by a change in MPV , but also improves metabolic abnormalities .
CONCLUSIONS	Amlodipine also has beneficial effects in patients with the metabolic syndrome but has no effect on MPV .

###23335039
OBJECTIVE	Trials with the antioxidant vitamin E have failed to show benefit in the general population .
OBJECTIVE	Considering the different causes of death in ESRD , this study investigated the association between plasma concentrations of - tocopherol and specific clinical outcomes in diabetic hemodialysis patients .
METHODS	In 1046 diabetic hemodialysis patients ( participants of the German Diabetes and Dialysis Study ) , - tocopherol was measured in plasma by reversed-phase HPLC .
METHODS	By Cox regression analyses , hazard ratios were determined for prespecified end points according to baseline plasma - tocopherol levels : sudden death ( n = 134 ) , myocardial infarction ( n = 172 ) , stroke ( n = 89 ) , combined cardiovascular events ( n = 398 ) , fatal infection ( n = 107 ) , and all-cause mortality ( n = 508 ) .
RESULTS	Patients had a mean age of 668 years , and mean plasma - tocopherol level was 22.89.6 mol/L .
RESULTS	Levels of - tocopherol were highly correlated to triglycerides ( r = 0.63 , P < 0.001 ) .
RESULTS	Patients in the lowest - tocopherol quartile had ( in unadjusted analyses ) a 79 % higher risk of stroke and a 31 % higher risk of all-cause mortality compared with patients in the highest quartile .
RESULTS	The associations were attenuated after adjustment for confounders ( hazard ratiostroke = 1.56 , 95 % confidence interval = 0.75-3 .25 ; hazard ratiomortality = 1.22 , 95 % confidence interval = 0.89-1 .69 , respectively ) .
RESULTS	There was no association between - tocopherol and myocardial infarction , sudden death , or infectious death .
CONCLUSIONS	Plasma - tocopherol concentrations were not independently associated with cardiovascular outcomes , infectious deaths , or all-cause mortality in diabetic hemodialysis patients .
CONCLUSIONS	The lack of association can partly be explained by a confounding influence of malnutrition , which should be considered in the planning of trials to reduce cardiovascular risk in dialysis patients .

###22951075
BACKGROUND	Intragastric balloons are designed to occupy space within the stomach and induce satiety .
BACKGROUND	The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone .
METHODS	After approval from the institutional review board , patients provided written consent and were randomized to the treatment group ( TG ) or control group ( CG ) in a 2:1 ratio .
METHODS	Three sites randomized a total of 30 patients to the TG ( n = 21 ) or CG ( n = 9 ) .
METHODS	Patients randomized to the TG underwent endoscopic placement of the dual balloon .
METHODS	Both groups received similar diet and exercise counseling .
METHODS	After 24 weeks , the device was removed .
METHODS	Patient weight , adverse events , and quality of life data were evaluated throughout the 48-week study duration .
RESULTS	Our patient population included 26 women and 4 men aged 26-59 years .
RESULTS	At 24 weeks , the mean excess weight loss in the TG and CG was 31.8 % 21.3 % and 18.3 % 20.9 % , respectively ( P = .1371 ) .
RESULTS	At 48 weeks , 24 weeks after device removal , the TG maintained 64 % of their weight loss .
RESULTS	No deaths , unanticipated adverse effects , early removals , balloon deflations , or balloon migrations occurred .
RESULTS	In the TG , 4 patients were readmitted for severe nausea , 1 had asymptomatic gastritis at balloon removal , and 1 patient experienced transient hypoxia during device removal .
CONCLUSIONS	In the present small study , the dual balloon proved easy to use , was associated with a trend toward greater weight loss than the CG , and demonstrated a good safety profile .

###24147869
BACKGROUND	In routine practice , irritable bowel syndrome ( IBS ) symptoms are often difficult to be relieved and impair significantly patients ' quality of life ( QoL ) .
BACKGROUND	A randomised , double-blind , placebo-controlled study has shown the efficacy of alverine citrate/simeticone ( ACS ) combination for IBS symptom relief .
OBJECTIVE	As IBS symptoms are often intermittent , this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments .
METHODS	Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies : on-demand ACS or usual treatment chosen by the physician .
METHODS	The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6 .
RESULTS	A total of 436 patients ( mean age : 54.4 years ; women : 73.4 % ) were included , 222 in the ACS arm and 214 patients in the usual treatment arm , which was mainly antispasmodics .
RESULTS	At 6 months , improvement of IBSQoL was greater with ACS than with the usual treatment group ( 13.8 vs. 8.4 ; p < 0.0008 ) .
RESULTS	The IBS-severity symptom score ( IBS-SSS ) was lower with ACS than in the usual treatment arm with a mean ( SE ) decrease of 170.0 ( 6.6 ) vs. 110.7 ( 6.7 ) , respectively ( p = 0.0001 ) .
RESULTS	An IBS-SSS < 75 was more frequent in the ACS group ( 37.7 % vs. 16.0 % ; p < 0.0001 ) .
RESULTS	Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment , which was associated with both lower direct and indirect costs .
CONCLUSIONS	After 6 months , on-demand ACS treatment led to a greater improvement of QoL , reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments .

###18294750
OBJECTIVE	The purpose of this study was to evaluate the effects of a home bleaching gel containing 15 % carbamide peroxide on the surface microhardness of four tooth-colored restorative materials in situ .
METHODS	Four types of tooth-colored restorative materials , including a nanocomposite resin ( Filtek Z350 ) , a packable composite resin ( Filtek P60 ) , a polyacid-modified composite ( Dyract AP ) , and a glass-ionomer cement ( Ketac Molar Easymix ) , were used in this study .
METHODS	Each material was divided into two groups equally ( n = 18 ) : bleaching group and control group .
METHODS	Thirty-six Chinese volunteers were recruited and stone casts were constructed for their upper jaws .
METHODS	Two of the four types of restorative materials were randomly selected and mounted on the first or second molar of the cast for each subject .
METHODS	With respect to each material selected , two specimens from each group were put at a random side .
METHODS	Then custom-fabricated trays containing specimens were fabricated .
METHODS	The participants wore the tray in the daytime , and applied the bleaching gel for the side containing specimens of bleaching group during the night .
METHODS	Surface microhardness measurements were obtained on the top surface of each sample on the different time periods .
RESULTS	There was a statistically significant increase in the surface microhardness of Ketac Molar Easymix due to the exposure to 15 % carbamide peroxide , while it produced a significant decrease for Dyract AP .
RESULTS	Following immersing in saliva without bleaching agent , Ketac Molar Easymix showed a significant increase in surface microhardness .
CONCLUSIONS	The effects of 15 % carbamide peroxide on surface microhardness were material dependent .
CONCLUSIONS	Immersing in saliva produced a surface hardening effect of glass-ionomer cement .

###20565345
OBJECTIVE	To compare the efficacy and safety of a 10-day , high-dose v a 3-month , continuous low-dose oral cholecalciferol course in a vitamin D deficient population .
OBJECTIVE	The primary end points were the change in serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentrations at 3 months and the development of hypercalcaemia and hypercalciuria .
METHODS	Fifty-nine vitamin D deficient inpatients ( serum 25 ( OH ) D < or = 50 nmol/L ) were enrolled in a prospective , randomised , open-label trial .
METHODS	Participants were randomly assigned to a high-dose regimen of cholecalciferol 50 000 IU daily for 10 days or a 3-month , continuous low-dose cholecalciferol regimen of 3000 IU daily for 30 days , followed by 1000 IU daily for 60 days .
METHODS	Both groups received calcium citrate 500 mg daily .
RESULTS	Twenty-six patients completed the study within 3 - or + 1 months .
RESULTS	The mean increases in serum 25 ( OH ) D were similar in both the high - and low-dose groups ( to 55 v 51 nmol/L , respectively ; P = 0.9 ) .
RESULTS	There was no significant difference in the proportion of subjects who attained serum 25 ( OH ) D concentrations > 50 nmol/L between the high - and low-dose groups ( 9/10 v 13/14 , respectively ; P = 1.0 ) .
RESULTS	Hypercalciuria ( urine calcium > 7.5 mmol/day ) occurred in three patients ( two low-dose , one high-dose ) , while renal impairment worsened in one patient .
RESULTS	No patient developed hypercalcaemia ( corrected calcium > 2.6 mmol/L ) , vitamin D toxicity ( 25 ( OH ) D > 200 nmol/L ) or nephrolithiasis during the study .
CONCLUSIONS	Both the 10-day , high-dose and the 3-month , low-dose cholecalciferol regimens effectively increased serum 25 ( OH ) D to within the normal range .
CONCLUSIONS	The high-dose regimen may be an effective and cheap alternative for patients with vitamin D deficiency .
BACKGROUND	Australian Clinical Trials Registry ACTRN 12607000338460 .

###15328178
OBJECTIVE	Arzoxifene , a new selective estrogen receptor modulator with strong breast antiestrogen activity and absence of uterine agonist activity , was explored as a potential chemoprevention agent .
OBJECTIVE	We performed a multi-institutional evaluation of arzoxifene in women with newly diagnosed ductal carcinoma in situ or T1/T2 invasive cancer .
METHODS	In a Phase IA trial , 50 pre - or postmenopausal women were randomized to 10 , 20 , or 50 mg of arzoxifene daily in the interval between biopsy and re-excision or were enrolled as no-treatment controls .
METHODS	In a Phase IB trial , 76 postmenopausal women were randomized to 20 mg of arzoxifene versus matched placebo .
METHODS	Serum specimens collected at entry and at re-excision were assayed for various hormones and growth factors .
METHODS	Tissue from biopsies ( estrogen receptor + and/or progesterone receptor + ) and re-excision specimens was evaluated immunohistochemically for proliferation ( Ki-67 by MIB-1 and proliferating cell nuclear antigen ) and other biomarkers .
RESULTS	In both trials , increases in serum sex hormone binding globulin were noted , as were decreases in insulin-like growth factor ( IGF ) - I and the IGF-I : IGF binding protein-3 ratio ( P < 0.007 versus control/placebo ) .
RESULTS	For 45 evaluable women in Phase IA , decreases in proliferation indices were more prevalent for arzoxifene ( particularly 20 mg ) than for controls .
RESULTS	For 58 evaluable women in Phase IB , a decrease in estrogen receptor expression for arzoxifene was observed compared with no change with placebo ( P = 0.0068 ) .
RESULTS	However , decreases in proliferation indices for arzoxifene were not statistically different from placebo , perhaps due to a confounding effect of stopping hormone replacement therapy before entry .
CONCLUSIONS	Given the favorable side effect profile and the biomarker modulations reported here , arzoxifene remains a reasonable candidate for additional study as a breast cancer chemoprevention agent .

###9187174
OBJECTIVE	This study was designed ( 1 ) to investigate the effects of normothermic and hypothermic perfusion on the median frequency of the fibrillating myocardium , and ( 2 ) to elucidate whether frequency-guided countershock therapy improves countershock success during the reperfusion phase of cardiac surgery .
METHODS	Prospective , randomized study .
METHODS	University hospital cardiac surgery room .
METHODS	Thirty patients ( first part of the study ) and 38 patients ( second part of the study ) scheduled for elective coronary artery bypass surgery .
RESULTS	During cardiopulmonary bypass , ventricular fibrillation ( VF ) was induced at a core body temperature of 34.1 + / -0.2 degrees C ( normothermia ) ( n = 15 ) or at a core body temperature of 29.8 + / -0.2 degrees C ( hypothermia ) ( n = 15 ) .
RESULTS	Using fast Fourier transformation of the ECG signal , median fibrillation frequency was recorded continuously for a period of 120 s.
RESULTS	At the end of surgery , countershock was performed as soon as VF was recognized on the ECG monitor ( X Hz group ; n = 19 ) or countershock was not performed until median fibrillation frequency had increased to the threshold of at least 5 Hz ( 5 Hz group ; n = 19 ) .
RESULTS	Median fibrillation frequency in the normothermic fibrillation group was statistically higher than in the hypothermic group .
RESULTS	In the X Hz and 5 Hz countershock group , median fibrillation frequency before the first countershock attempt was 3.6 + / -0.2 Hz and 5.4 + / -0.1 Hz ( p < 0.0001 ) , respectively .
RESULTS	In the X Hz group , six countershocks resulted in supraventricular rhythm , 10 in VF , two in electromechanical dissociation , and one in asystole .
RESULTS	In the 5 Hz group , 16 countershocks resulted in supraventricular rhythm , two in VF , and one in asystole ( p = 0.008 ) .
CONCLUSIONS	During normothermia , median fibrillation frequency is significantly higher than during hypothermic perfusion conditions .
CONCLUSIONS	During the reperfusion phase of cardiac surgery , countershock success rate is significantly higher when a threshold of at least 5 Hz had been reached before the first countershock attempt .

###15319024
OBJECTIVE	This study investigated the psychometric properties of a new clinician-rated scale designed to assess the severity of social phobia and measure treatment outcome in adolescents : the Kutcher Generalized Social Anxiety Disorder Scale for Adolescents ( K-GSADS-A ) .
METHODS	Two hundred fifty-one ( 251 ) adolescents ( 11-17 years ; mean age 14.2 years ) with DSM-IV social phobia enrolled in a multicenter , 16-week , double-blind , placebo-controlled study of paroxetine .
METHODS	Efficacy assessments were conducted at baseline and at weeks 4 , 8 , 12 , and 16 with the K-GSADS-A , three other clinician-rated scales ( including the Clinical Global Impression of Severity scale ) , and a self-rated social phobia scale .
METHODS	Additionally , the Clinical Global Impression of Improvement scale was administered at each postbaseline assessment , and the Children 's Depression Rating Scale-Revised was administered at baseline and at week 16 .
METHODS	These data were used to assess the internal consistency , convergent and divergent validity , and sensitivity to change of the K-GSADS-A .
RESULTS	The internal consistency of the K-GSADS-A was adequate , and supportive evidence was obtained for its convergent validity with other severity measures , and its divergent validity with respect to depression .
RESULTS	The K-GSADS-A also demonstrated good sensitivity to changes in severity .
CONCLUSIONS	These results suggest that the K-GSADS-A is a valid measure of treatment outcome in adolescents with DSM-IV social phobia .

###20006921
OBJECTIVE	To evaluate the combination of the gastrin antagonist Z-360 and gemcitabine for advanced pancreatic cancer .
METHODS	Previously untreated patients with PC were randomly allocated to Z-360 120 mg , 240 mg or placebo .
METHODS	Z-360 / placebo was given on day -3 and gemcitabine 1000 mg/m ( 2 ) commenced on day 1 followed by Z-360 on day 2 .
METHODS	Thereafter Z-360 / placebo was given twice daily concurrently with standard dose of gemcitabine .
METHODS	Pharmacokinetics for both drugs was measured alone and in combination .
METHODS	Toxicity , response and quality of life were also recorded .
RESULTS	Thirty-three patients with a median age of 62 years were randomised of which six had locally advanced disease and 26 had metastatic disease .
RESULTS	Analysis of the area under the plasma concentration versus time curve ( AUC ) , the maximum observed concentration ( Cmax ( obs ) ) and the time of the maximum observed concentration ( Tmax ( obs ) ) for Z-360 , gemcitabine and 2,2-difluorodeoxyuridine ( dFdU ) , could not exclude an effect on the systemic exposure to Z-360 , gemcitabine and dFdU when co-administration of Z-360 and gemcitabine was compared with single agent administration .
RESULTS	The most commonly reported adverse events were nausea , abdominal pain , vomiting and fatigue .
RESULTS	At the end of the study , 62.5 % , 25 % and 60 % had stable disease in the 120 mg , 240 mg and placebo group , respectively .
RESULTS	A higher proportion of patients in Z-360 groups reported improvement in pain .
CONCLUSIONS	Z-360 is safe and well tolerated when combined with gemcitabine .
CONCLUSIONS	A Phase III trial is needed to determine whether the combination of Z-360 and gemcitabine is superior to gemcitabine alone in advanced PC .

###10614063
OBJECTIVE	Previous data indicate that even mild postprandial hyperglycaemia in diabetic subjects , who are concerned to be in good control , activates haemostasis .
OBJECTIVE	The aim of this study was to investigate the effect of the oral administration of 5 mg glibenclamide on postprandial activation of coagulation in type 2 diabetics .
RESULTS	We designed a placebo controlled , randomised study .
RESULTS	After an overnight fast , each subject ( n = 16 , age 50-68 yr . )
RESULTS	underwent a standard test meal ( 600 Kcal : carbohydrates 40 % , lipids 50 % , proteins 10 % ) preceded by one tablet of glibenclamide ( 5 mg ) or placebo .
RESULTS	The two tests were performed randomly , with an interval of 7 days .
RESULTS	Blood samples were collected at baseline and 2 and 4 hours after the meal to measure the concentrations of glucose , insulin , c-peptide , triglycerides as well as of d-dimers , fibrinogen , F1 .2 and TAT .
RESULTS	The postprandial levels of TAT , fibrinogen , F1 .2 , d-dimers , insulin , glucose and triglycerides were significantly higher compared to baseline values .
CONCLUSIONS	The postprandial levels of glucose , triglycerides , fibrinogen , F1 .2 , TAT and d-dimers were lower after glibenclamide administration as compared to placebo , while the concentrations of insulin and c-peptide were higher .
CONCLUSIONS	Thus , acute administration of glibenclamide reduces the postprandial activation of coagulation .

###19923636
BACKGROUND	The delayed-release combination of doxylamine succinate and pyridoxine hydrochloride was the most commonly used antiemetic ( Bendectin ) approved by FDA for nausea and vomiting of pregnancy ( NVP ) until its removal of the market in 1983 .
BACKGROUND	The drug is widely used today in Canada ( Diclectin ) .
BACKGROUND	The pharmacokinetics of Diclectin has never been described in humans .
OBJECTIVE	To compare the pharmacokinetics of Diclectin to oral solutions of its two components .
METHODS	A randomized , cross over , open label design , comparing the pharmacokinetics of Diclectin to those of the oral solutions of the two components in 18 healthy adult , non pregnant women of childbearing age .
RESULTS	Diclectin exhibited similar oral bioavailability to those of the oral solutions .
RESULTS	In contrast , the time-to-peak , ( Tmax ) , reflecting the rate of absorption , was 3-6 times longer for the two components of the delayed-release drug confirming its delayed-release characteristics .
CONCLUSIONS	The pharmacokinetic profile of Diclectin well explains its documented delayed efficacy .

###12135217
OBJECTIVE	To establish the accuracy of saline infusion hysterosonography in diagnosing uterine pathology when compared with outpatient hysteroscopy .
METHODS	Prospective , parallel , blinded comparative study .
METHODS	Outpatient hysteroscopy clinic in a large university teaching hospital .
METHODS	All women referred for outpatient hysteroscopy in a 15-month period .
METHODS	Women underwent saline infusion hysterosonography followed by flexible hysteroscopy .
METHODS	The ultrasonographer was blinded to the hysteroscopy result and the gynaecologist was blinded to the saline infusion hysterosonography result .
METHODS	The relative success rates and pain scores for each procedure .
METHODS	The validity of saline infusion hysterosonography as a diagnostic test .
RESULTS	One hundred and seventeen women entered the study ; 70 women were premenopausal and 47 postmenopausal .
RESULTS	In 27 women , one or both procedures could not be performed .
RESULTS	Saline infusion hysterosonography failed in 20 women , on one occasion hysteroscopy failed and both investigations failed in six women .
RESULTS	Ninety cases remained for direct comparison , with 78 cases of agreement on the uterine findings in both investigations .
RESULTS	Twelve cases disagreed ; in one case , an adhesion was seen , two cases with polyps and five with fibroids seen on ultrasound but not seen on hysteroscopy .
RESULTS	There were four cases where polyps were identified on hysteroscopy but not on saline infusion hysterosonography .
RESULTS	The median pain scores were 1.6 for saline infusion hysterosonography and 3.2 for hysteroscopy .
CONCLUSIONS	Both saline infusion hysterosonography and hysteroscopy are well tolerated by women .
CONCLUSIONS	Saline infusion hysterosonography has a high failure rate but has a lower pain score than hysteroscopy .

###24047644
OBJECTIVE	To determine the effects of a six-month physical activity stimulation programme on social participation , self-perception and quality of life in children with cerebral palsy .
METHODS	Multicentre randomized controlled trial with concealed allocation , blinded assessments and intention-to-treat analysis .
METHODS	Paediatric physiotherapy practices , special schools for children with a disability , and the child 's own home .
METHODS	Forty-nine children with spastic cerebral palsy ( 28 male ) , aged 7-13 years , able to walk with and without walking aids .
METHODS	The intervention group followed a six-month physical activity stimulation programme involving counselling through motivational interviewing , home-based physiotherapy and four months of fitness training .
METHODS	The control group continued regular paediatric physiotherapy .
METHODS	Outcomes included social participation in domestic life , social participation in recreation and leisure ( Life-Habits for Children questionnaire and Children 's Assessment of Participation and Enjoyment questionnaire ) , self-perception ( Harter 's Self-Perception Profile for Children ) and parent-reported quality of life ( Cerebral Palsy Quality of Life Questionnaire ) .
METHODS	Assessments were performed at baseline , at six months ( except quality of life ) and at twelve months .
RESULTS	Intervention resulted in a positive effect on social participation in domestic life at twelve months ( mean between-group difference = 0.9 , 95 % confidence interval ( CI ) = 0.1 to 1.7 [ 1-10 scale ] , P = 0.03 ) , but not at six months .
RESULTS	No significant effects were found for social participation in recreation and leisure , self-perception at six months and twelve months or for quality of life at twelve months .
CONCLUSIONS	The combination of counselling , home-based physiotherapy and fitness training was not effective in improving social participation in recreation and leisure , self-perception or quality of life , but did show a potential for improving social participation in domestic life over the longer term .

###17118687
OBJECTIVE	Obese subjects have functional growth hormone deficiency ( GHD ) .
OBJECTIVE	Recombinant human GH ( rhGH ) treatment of pituitary GHD improves serum levels of leptin , adiponectin and C-reactive protein ( CRP ) .
OBJECTIVE	This study was undertaken to determine whether these rhGH-induced changes occur in obese subjects during rhGH supplementation .
METHODS	Randomized double-blind placebo-controlled trial of low-dose rhGH ( 200 microg/day for the first month , then 400 microg/day for men and 600 microg/day for women thereafter ) or placebo supplementation as an adjuvant to a standard weight loss program .
METHODS	Forty healthy obese subjects , 28 premenopausal menstruating women ( 35 + / -7 SD years ) and 12 men ( 37 + / -6 years ) .
METHODS	Body weight , BMI , body composition ( assessed by dual energy X-ray absorptiometry [ DEXA ] ) , and serum levels of glucose , insulin , IGF-I , IGFBP-3 , insulin resistance index ( homeostasis modal assessment [ HOMA ] ) , leptin , CRP and adiponectin were performed at baseline and at 6 months .
RESULTS	For similar entry BMI values , women when compared with men had higher percent body fat ( BF ) ( 43.5 + / -4.6 % vs. 29.8 + / -4.0 % , p < 0.001 ) , higher leptin levels ( 16.9 + / -8.4 microg/L vs. 4.2 + / -3.0 microg/L , p < 0.001 ) , and higher CRP levels ( 13.8 + / -16.8 mg/L vs. 2.4 + / -3.2 mg/L , p = 0.04 ) .
RESULTS	Serum levels of leptin and CRP , but not adiponectin , correlated significantly with BF in both sexes .
RESULTS	Recombinant human GH treatment increased levels of IGF-I Z-Score between baseline and 6 months ( from -0.7 + / -0.9 SD to 0.1 + / -1.1 SD , p = 0.01 ) and modestly decreased BF ( from 38.4 + / -7.8 % to 35.6 + / -7.5 % , p = 0.046 ) .
RESULTS	Despite increased IGF-I , there were no differences between rhGH and placebo with regard to changes in leptin , CRP , or adiponectin .
CONCLUSIONS	It is concluded that in obesity , although rhGH treatment significantly increases IGF-I and modestly reduces body fat , the lack of significant changes in serum leptin , adiponectin or CRP levels suggests that rhGH treatment does not have a significant effect on these serum markers of adiposity .

###18176329
BACKGROUND	Differences in adverse events by gender and race/ethnicity have not been described extensively in randomized clinical trials of HIV antiretroviral therapy ( ART ) .
METHODS	Antiretroviral-naive HIV-infected participants enrolled in a long-term randomized clinical trial of 3 different initial ART strategies -- protease inhibitor ( PI ) , nonnucleoside reverse transcriptase inhibitor ( NNRTI ) , or PI plus NNRTI-based combinations -- with a median follow-up of 5 years , were compared by gender and race for 14 categories of grade 4 adverse events , discontinuation of initial antiretroviral regimen , and all-cause mortality .
METHODS	Multivariate analysis was used to identify predictors of events and death .
RESULTS	Among 1301 participants with complete data , there were 701 blacks , 225 Latinos , and 263 women .
RESULTS	Several baseline characteristics differed by gender and race , including age , HIV transmission risk , hepatitis B or C coinfection , viral load , diagnosis of AIDS , body mass index , and baseline hypertension .
RESULTS	Grade 4 events occurred in 409 participants ( rate : 8.9 / 100 person-years ) .
RESULTS	There were 176 deaths ( rate : 3.0 / 100 person-years ) and 523 discontinuations of regimen for any toxicity ( rate : 13/100 person-years ) .
RESULTS	In the fully adjusted regressions , blacks had greater risk for cardiovascular ( hazard ratio [ HR ] = 2.64 , 95 % confidence interval [ CI ] : 1.04 to 6.67 ) and renal ( HR = 3.83 , 95 % CI : 1.28 to 11.5 ) events .
RESULTS	Black men had more psychiatric events ( HR = 2.45 , 95 % CI : 1.13 to 5.30 ) .
RESULTS	Women had a higher risk for anemia ( HR = 2.34 , 95 % CI : 1.09 to 4.99 ) .
CONCLUSIONS	Among HIV-infected participants initiating ART , there were significant risk-adjusted differences for specific adverse events by gender and race but not in the overall adverse event rates , all-cause mortality , or rates of toxicity-related treatment discontinuations .

###20666811
BACKGROUND	Mohs micrographic surgery ( MMS ) is a tissue-sparing technique for the removal of cutaneous malignancies .
BACKGROUND	There is no standardized procedure for determining tumor extent before taking the initial margins during the first stage of Mohs .
OBJECTIVE	To compare visual inspection , curettage , and dermoscopy in determining tumor extent before initial margins are taken for MMS .
METHODS	Fifty-four patients were randomized into three groups ( visual inspection , curettage , or dermoscopy ) before MMS for basal cell carcinomas on the nose .
METHODS	One of these three methods was used to delineate the biopsy site or residual tumor .
METHODS	The final number of stages and postoperative defect sizes were recorded .
RESULTS	There was no statistically significant differences for the final number of stages ( p = .20 ) or the final defect sizes ( p = .47 ) between the three arms .
CONCLUSIONS	There has been controversy as to whether presurgical curettage is appropriate before MMS .
CONCLUSIONS	Some feel that curettage better delineates the tumor , leading to fewer stages , whereas others feel that curettage may falsely increase the final defect size , negating any tissue-sparing advantages of the procedure .
CONCLUSIONS	Our study did not demonstrate any differences in the final number of stages or postoperative defect sizes between the three test groups .

###23208648
BACKGROUND	Few HIV prevention interventions focus on sexual risk reduction as mutual process determined by couple members , though risk behaviors are inter-dependent .
OBJECTIVE	This trial examined the impact of substance use , history of sexual trauma , and intimate partner violence on sexual risk associated with participation in a risk reduction intervention .
METHODS	HIV seroconcordant and serodiscordant multicultural couples in Miami , Florida ( n = 216 ) were randomized to group ( n = 112 ) or individual ( n = 104 ) couple-based interventions .
RESULTS	Group intervention participants increased condom use in couples in which women had a history of sexual trauma [ F ( 2,221 ) = 3.39 , p = 0.036 ] and by partners of alcohol users .
RESULTS	History of sexual trauma was a determinant of conflict resolution , predicting negative communication and intimate partner violence .
CONCLUSIONS	Results emphasize the need for group sexual risk reduction interventions targeting sexual trauma , partner violence , and substance use among HIV seroconcordant and serodiscordant couples .

###24854808
OBJECTIVE	Although there is general agreement that parents should be involved in pediatric obesity treatment , few studies have investigated the effectiveness of interventions that target parents exclusively .
OBJECTIVE	Moreover , the effectiveness of this approach has not been adequately assessed with racially diverse families , particularly African Americans ( AA ) , a group at high risk for elevated Body Mass Index ( BMI ) .
METHODS	NOURISH ( Nourishing Our Understanding of Role modeling to Improve Support and Health ) is a culturally-sensitive parenting intervention targeting overweight ( AA ) children ( ages 6-11 ; MBMI = 98.0 % ile ) .
METHODS	Families ( N = 84 ; 61 % AA , 37 % White ) were randomly assigned to NOURISH or a control group .
RESULTS	NOURISH families significantly improved on child BMI from pre - to post-testing after adjustment for random effects , baseline BMI , and child race .
RESULTS	NOURISH parents were very satisfied with the intervention and would recommend it to other parents ; 91 % strongly or moderately agreed that NOURISH helped them eat in a healthier manner .
CONCLUSIONS	These pilot data suggest that NOURISH is acceptable and , with refinement , offers promise for reducing pediatric BMI .
CONCLUSIONS	Outcomes , lessons learned , and parent feedback will inform a larger randomized controlled trial .

###22620693
OBJECTIVE	To compare the cardiorespiratory , gastrointestinal , analgesic , and behavioral effects between IV and IM administration of morphine in conscious horses with no signs of pain .
METHODS	6 healthy adult horses .
METHODS	Horses received saline ( 0.9 % NaCl ) solution ( IM or IV ) or morphine sulfate ( 0.05 and 0.1 mg/kg , IM or IV ) in a randomized , masked crossover study design .
METHODS	The following variables were measured before and for 360 minutes after drug administration : heart and respiratory rates ; systolic , diastolic , and mean arterial blood pressures ; rectal temperature ; arterial pH and blood gas variables ; intestinal motility ; and response to thermal and electrical noxious stimuli .
METHODS	Adverse effects and horse behavior were also recorded .
METHODS	Plasma concentrations of morphine , morphine-3-glucuronide , and morphine-6-glucuronide were measured via liquid chromatography-mass spectrometry .
RESULTS	No significant differences in any variable were evident after saline solution administration .
RESULTS	Intravenous and IM administration of morphine resulted in minimal and short-term cardiorespiratory , intestinal motility , and behavioral changes .
RESULTS	A decrease in gastrointestinal motility was detected 1 to 2 hours after IM administration of morphine at doses of 0.05 and 0.1 mg/kg and after IV administration of morphine at a dose of 0.1 mg/kg .
RESULTS	Morphine administration yielded no change in any horse 's response to noxious stimuli .
RESULTS	Both morphine-3-glucuronide and morphine-6-glucuronide were detected in plasma after IV and IM administration of morphine .
CONCLUSIONS	Clinically relevant doses of morphine sulfate yielded minimal and short-term behavioral and intestinal motility effects in healthy horses with no signs of pain .
CONCLUSIONS	Neither dose of morphine affected their response to a noxious stimulus .

###21978929
BACKGROUND	The mainstay of treatment in bronchiolitis includes oxygenation , aspiration of secretions from the respiratory tract and maintenance of hydration .
BACKGROUND	The first choice medical agent in clinical practice is nebulized bronchodilators , although their place in treatment is controversial .
OBJECTIVE	We investigated the therapeutic benefit of nebulized hypertonic ( 3 % ) saline ( HS ) , by comparing four different nebulized regimens in the treatment of bronchiolitis in the emergency department .
METHODS	A total of 120 infants were included in this randomized , double-blind , prospective study.Infants were grouped according to the nebulized treatment they received : group 1 - salbutamol + normal saline ( NS ) , group 2 - salbutamol + HS , group 3 - HS , group 4 - NS .
METHODS	Heart beat , Clinical Bronchiolitis Severity Score ( CBSS ) and oxygen saturation of the patients were determined before and after the nebulizations and at 48-72h after admission by the designated study physician .
RESULTS	Post-treatment mean CBSS were significantly lower than pre-treatment scores in all groups ( p = 0.0001 ) with no significant difference within groups .
RESULTS	Improvement percentages for CBSSs were significantly higher in infants without a history of atopy treated with HS and NS ( p = 0.023 , p = 0.0001 , respectively ) .
CONCLUSIONS	The CBSSs of all the infants improved after three doses of nebulized therapy regardless of the treatment regimens .
CONCLUSIONS	The combination of salbutamol with hypertonic saline did not lead to an additive effect in the improvement of CBSSs compared to the standard salbutamol + NS combination .
CONCLUSIONS	Atopic children benefited from salbutamol/NS combination whereas non-atopic children improved with HS and NS nebulizations based on improvement percentages of CBSS .

###9193243
OBJECTIVE	To determine if cerebral palsy ( CP ) rates were lower in the active treatment group compared with the control group , as improved survival rates of very low-birth-weight infants are postulated to be the cause of the increased incidence of CP in preterm infants , to evaluate relationships between multiple prenatal , perinatal , and postnatal variables and CP to understand better its antecedents in very low-birth-weight infants in the era of surfactant replacement therapy , and to determine the usefulness of a cranial ultrasonographic ( US ) scan in predicting CP .
METHODS	Inception cohort follow-up study as part of a randomized controlled trial of low-dose indomethacin sodium for the prevention of intraventricular hemorrhage .
METHODS	Neonatal intensive care units at 3 medical centers .
METHODS	Infants with birth weights between 600 and 1250 g were eligible , and 505 infants were enrolled in the original study .
METHODS	Of these infants , 440 ( 87 % ) survived ; neurologic examinations were completed on 381 infants ( 86 % ) at 36 months corrected age .
METHODS	Statistical analyses were performed to identify the antecedents of CP , including the results of frequent cranial US scans obtained throughout the newborn period .
RESULTS	Cerebral palsy was found in 36 ( 9.5 % ) of 381 infants at 36 months corrected age ( range , 33-39 months corrected age ) .
RESULTS	Univariate analysis identified chorioamnionitis , treatment with surfactant , bronchopulmonary dysplasia , and abnormal cranial US findings as antecedents of CP .
RESULTS	Periventricular leukomalacia and ventriculomegaly were associated with the highest detection rates for CP ( 37 % and 30 % , respectively ) with acceptable false-positive rates .
RESULTS	Multivariate analysis identified bronchopulmonary dysplasia and an abnormal cranial US scan showing grade 3 to 4 intraventricular hemorrhage , periventricular leukomalacia , or ventriculomegaly as independent predictors of CP .
RESULTS	Odds ratios for the detection of CP using cranial US findings tabulated by hospital day were in the range of 7 to 26 beginning on day 2 .
CONCLUSIONS	The results suggest that cranial US findings are useful predictors of CP during a patient 's stay in the hospital .

###10708161
OBJECTIVE	Glutathione ( GSH ) is a potent endogenous antioxidant that serves as one of the body 's most important defenses against oxygen metabolites .
OBJECTIVE	Plasma levels of GSH are maintained primarily by a balance between secretion from the liver and degradation in the kidney .
OBJECTIVE	The ability to maintain and enhance tissue GSH may be of particular importance in controlling cytokine production in response to a stimulus like injury .
OBJECTIVE	The interaction after severe trauma between GSH and cytokines , tumor necrosis factor ( TNF ) - alpha , and interleukin ( IL ) -6 , are not known .
OBJECTIVE	The purpose of the study was to investigate the levels of plasma GSH and cytokines TNF-alpha and IL-6 in adult patients admitted to the intensive care unit of our level I trauma center who were treated with recombinant human growth hormone ( rhGH ) for > or = 7 days .
METHODS	Prospective , randomized , controlled trial .
METHODS	Trauma intensive care unit .
METHODS	Twenty-eight patients with multiple injuries and 14 normal postabsorptive controls .
METHODS	From 48-60 hrs after injury , when resuscitation was complete , a stable hemodynamic status was achieved and the patients were receiving maintenance fluid without nitrogen or calories , a blood sample was drawn for basal , plasma GSH , TNF-alpha , and IL-6 measurement .
METHODS	Intravenous feeding was then started and continued for 7 days .
METHODS	The patients were randomized to receive or not to receive daily intramuscular doses of recombinant human growth hormone ( 0.15 mg rhGH/kg/day ) .
METHODS	Daily morning plasma was obtained for analysis of GSH , TNF-alpha , and IL-6 levels .
RESULTS	In the early catabolic `` flow phase '' of severe injury , the plasma levels of GSH were not altered but plasma TNF-alpha and IL-6 levels were increased significantly , compared with uninjured controls .
RESULTS	Seven days of total parenteral nutrition alone enhanced plasma GSH levels ( 76 % ) , but no change in TNF-alpha was observed .
RESULTS	Supplementation with rhGH enhanced GSH ( 180 % ) , and TNF ( 65 % ) with no changes in IL-6 levels .
RESULTS	There is a significant linear relationship between plasma GSH and TNF-alpha levels in our rhGH-supplemented trauma patients .
CONCLUSIONS	Modification of plasma GSH and TNF-alpha levels by adequate nutritional support with adjuvant rhGH during the postinjury period demonstrates the beneficial role of GSH in enhancing antioxidant defenses .

###24059292
BACKGROUND	Non-adherence to HIV-treatment can have a negative impact on patients treatment success rates , quality of life , infectiousness , and life expectancy .
BACKGROUND	Few adherence interventions have shown positive effects on adherence and/or virologic outcomes .
BACKGROUND	The theory - and evidence-based Adherence Improving self-Management Strategy ( AIMS ) is an intervention that has been demonstrated to improve adherence and viral suppression rates in a randomised controlled trial .
BACKGROUND	However , evidence of its cost-effectiveness is lacking .
BACKGROUND	Following a recent review suggesting that cost-effectiveness evaluations of adherence interventions for chronic diseases are rare , and that the methodology of such evaluations is poorly described in the literature , this manuscript presents the study protocol for a multi-centre trial evaluating the effectiveness and cost-effectiveness of AIMS among a heterogeneous sample of patients .
METHODS	The study uses a multi-centre randomised controlled trial design to compare the AIMS intervention to usual care from a societal perspective .
METHODS	Embedded in this RCT is a trial-based and model-based economic evaluation .
METHODS	A planned number of 230 HIV-infected patients are randomised to receive either AIMS or usual care .
METHODS	The relevant outcomes include changes in adherence , plasma viral load , quality of life , and societal costs .
METHODS	The time horizon for the trial-based economic evaluation is 12-15 months .
METHODS	Costs and effects are extrapolated to a lifetime horizon for the model-based economic evaluation .
CONCLUSIONS	The present multicentre RCT is designed to provide sound methodological evidence regarding the effectiveness and cost-effectiveness of a nurse-based counselling intervention ( AIMS ) to support treatment adherence among a large and heterogeneous sample of HIV-infected patients in the Netherlands .
CONCLUSIONS	The objective of the current paper is to describe the trial protocol in sufficient detail to allow full evaluation of the quality of the study design .
CONCLUSIONS	It is anticipated that , if proven cost-effective , AIMS can contribute to improved evidence-based counselling guidelines for HIV-nurses and other health care professionals .
BACKGROUND	The study has been registered on clinicaltrials.gov ( Identifier : NCT01429142 ) .

###19208045
OBJECTIVE	To compare changes in stress reactivity ( measured via the biomarker salivary cortisol ) and behavioral state in healthy newborn infants immediately following 1 of 2 interventions : ( 1 ) tactile-only stimulation or ( 2 ) a multisensory , auditory , tactile , visual , and vestibular stimulation with a control group .
METHODS	A randomized prospective design pilot study .
METHODS	Normal newborn nurseries of 2 midwestern perinatal centers .
METHODS	Forty healthy newborn infants receiving standard nursing care .
METHODS	Infants were randomly assigned to receive 15 minutes of tactile-only , auditory , tactile , visual , and vestibular , or no stimulation 30 minutes before feeding .
METHODS	Saliva samples were collected before , immediately following , and 10 minutes postintervention .
METHODS	Behavioral state was judged every minute .
RESULTS	Tactile-only group infants had the largest increase in cortisol levels , followed by control group infants .
RESULTS	In contrast , infants who received the multisensory intervention showed a significant steady decline in cortisol .
RESULTS	Asleep was the predominant state for all 3 groups and cry was minimal .
CONCLUSIONS	Tactile-only stimulation may increase infant stress reactivity while the benefit of the multisensory auditory , tactile , visual , and vestibular intervention may be in the reduction of infant stress reactivity .
CONCLUSIONS	Interventions appeared to have minimal effect on stress reactivity based on behavioral state .

###10382786
OBJECTIVE	The purpose of this study was to investigate the effects of interleukin-1 receptor antagonist ( IL-1ra ) on myocardial function in septic patients .
METHODS	A subgroup of patients from a prospective , randomized , double-blind , placebo-controlled , multicenter trial was studied from 63 academic medical centers in the United States , Canada , and Europe .
METHODS	A subgroup of 71 patients with severe sepsis in whom vasoactive support was little altered during the study was included .
METHODS	The patients were randomized to receive either placebo ( n = 29 ) or IL-1ra at a dose of 1 mg/kg/h ( n = 20 ) or 2 mg/kg/h ( n = 22 ) .
RESULTS	Hemodynamic measurements were taken at baseline , and 1 , 2 , 3 , 4 , 8 , and 12 hours after placebo or IL-1ra administration .
RESULTS	No significant differences in hemodynamic parameters were observed between the groups or over time during the study period .
CONCLUSIONS	IL-1ra administration has no effect on cardiac function in septic patients .

###25638793
BACKGROUND	Hamilton depression rating scale ( HAMD ) subscales provide an economic alternative for the full scale ; however , their ability to detect onset of improvement in the early course of treatment ( EI ) has not yet been researched .
BACKGROUND	The present study investigated in patients with major depression ( MD ) whether the subscales are a comparable option to predict treatment remission in the early course of treatment .
METHODS	Based on data from 210 MD patients of a 6-week randomised , placebo-controlled trial comparing mirtazapine ( MIR ) and paroxetine ( PAR ) , the discriminative and predictive validity of EI for ( stable ) remission at treatment end was evaluated for seven subscales and the HAMD17 in the total and in treatment subgroups ( MIR vs. PAR ) .
METHODS	Receiver operating characteristics ( ROC ) curves ( at week 2 ) and the Clinical Global Impression scales ( CGI ) ( at study endpoint ) were used to validate the 20 % EI criterion for the subscales .
RESULTS	Only the Evans6 and Toronto7 subscale had almost the same predictive value as the HAMD17 ( e.g. , sensitivities stable remission Evans6/Toronto7 : 96/95 % vs. 96 % HAMD17 ) .
RESULTS	The optimal cut-off for EI to predict remission was just below 20 % for most subscales and slightly over 20 % for stable remission .
CONCLUSIONS	Study sample representativeness , non-independence of subscales , missing external validation criterion , lack of control group .
CONCLUSIONS	The Evans6 and Toronto7 subscales are valuable alternatives in situations , where economic aspects play a larger role .
CONCLUSIONS	A sum score reduction of 20 % as definition for EI seems also appropriate for the HAMD subscales , in the total as well as in the antidepressant subgroups .

###14564321
BACKGROUND	Previous trials demonstrated the efficacy of platelet glycoprotein IIb/IIIa receptors blockade with tirofiban in reducing acute ischemic events in patients with unstable angina/non-ST-elevation myocardial infarction .
BACKGROUND	Little is known about the effect of tirofiban among women with acute coronary syndromes .
OBJECTIVE	We aimed to determine the benefit and safety of tirofiban plus heparin versus heparin alone on cardiac ischemic events among women with unstable angina/non-ST-elevation myocardial infarction .
RESULTS	We performed a post hoc analysis of all women enrolled in the PRISM-PLUS trial .
RESULTS	At early time points , there appeared to be a reduction of the primary composite end point of death , myocardial infarction , or refractory ischemia among women treated with tirofiban plus heparin ( RR , 0.78 and 0.67 ) compared with women treated with heparin alone .
RESULTS	However , at 30 and 180 days , there was no significant reduction of events with the combination therapy of tirofiban plus heparin ( treatment-by-sex interaction , P = .05 ) .
RESULTS	Death or myocardial infarction was not significantly reduced by the combination therapy among women at all time points .
CONCLUSIONS	Although the effects of tirofiban in reducing the primary composite outcome were similar among men and women early in the study , there appeared to be a difference at the later time points .
CONCLUSIONS	In particular , tirofiban was effective among men , but there was no clear effect among women at 30 and 180 days .

###23043722
OBJECTIVE	High supply of protein and energy has been introduced to very-low-birth-weight infants to improve growth and cognitive development .
OBJECTIVE	The aim of this study was to compare two different feeding strategies on postnatal growth and clinical outcome during neonatal hospitalization .
METHODS	Fifty very-low-birth-weight infants were randomized to either an enhanced or a standard feeding protocol within 24h after birth .
METHODS	Chi-square and T-tests were applied .
RESULTS	First week protein , fat and energy supply was significantly higher in the intervention group compared to the control group ( all P < 0.001 ) .
RESULTS	After inclusion of 50 patients we observed a higher occurrence of septicemia in the intervention group , 63 % vs. 29 % ( P = 0.02 ) , and no more patients were included .
RESULTS	The infants in the intervention group demonstrated improved postnatal growth , but they also disclosed significant electrolyte deviations during the first week of life with hypophosphatemia , hypokalemia and hypercalcemia .
RESULTS	First week phosphate nadir was lower in the infants experiencing septicemia ( 1.23 ( 0.50 ) mmol/L ) as compared to the infants without ( 1.61 ( 0.61 ) mmol/L ) ( P = 0.03 ) .
CONCLUSIONS	Our study implies that enhanced feeding may induce electrolyte imbalances in VLBW infants , and that deleterious side effects similar to those seen in refeeding syndrome may occur .
CONCLUSIONS	ClinicalTrials.gov , number NCT01103219 and the EudraCT number is 2010-020464-38 .

###22795291
BACKGROUND	The standard clinical approach for reducing cardiovascular disease risk due to dyslipidemia is to prescribe changes in diet and physical activity .
BACKGROUND	The purpose of the current study was to determine if , across a range of dietary patterns , there were variable lipoprotein responses to an aerobic exercise training intervention .
METHODS	Subjects were participants in the STRRIDE I , a supervised exercise program in sedentary , overweight subjects randomized to 6 months of inactivity or 1 of 3 aerobic exercise programs .
METHODS	To characterize diet patterns observed during the study , we calculated a modified z-score that included intakes of total fat , saturated fat , trans fatty acids , cholesterol , omega-3 fatty acids , and fiber as compared with the 2006 American Heart Association diet recommendations .
METHODS	Linear models were used to evaluate relationships between diet patterns and exercise effects on lipoproteins/lipids .
RESULTS	Independent of diet , exercise had beneficial effects on low-density lipoprotein cholesterol particle number , low-density lipoprotein cholesterol size , high-density lipoprotein cholesterol , high-density lipoprotein cholesterol size , and triglycerides ( P < .05 for all ) .
RESULTS	However , having a diet pattern that closely adhered to American Heart Association recommendations was not related to changes in these or any other serum lipids or lipoproteins in any of the exercise groups .
CONCLUSIONS	We found that even in sedentary individuals whose habitual diets vary in the extent of adherence to AHA dietary recommendations , a rigorous , supervised exercise intervention can achieve significant beneficial lipid effects .

###16958717
OBJECTIVE	To determine the effects of a prenatal breastfeeding workshop on maternal breastfeeding self-efficacy and breastfeeding duration .
METHODS	Randomized controlled trial .
METHODS	Large tertiary hospital in Ontario , Canada .
METHODS	110 primiparous women expecting a single child , an uncomplicated birth , and planning to breastfeed .
METHODS	2.5-hour prenatal breastfeeding workshop based on adult learning principles and self-efficacy theory .
METHODS	Maternal breastfeeding self-efficacy and the numbers of days and amount of breastfeeding were measured at four and eight weeks postpartum .
METHODS	RESULTS/DATA ANALYSIS : Over time , maternal breastfeeding self-efficacy scores increased in both groups .
METHODS	Women who attended the workshop had higher self-efficacy scores and a higher proportion were exclusively breastfeeding compared to women who did not attend the workshop .
METHODS	There was little difference in the average number of days of breastfeeding , but the intervention group had less weaning .
CONCLUSIONS	The workshop increased maternal breastfeeding self-efficacy and exclusive breastfeeding .

###24443547
BACKGROUND	Low-frequency nevirapine ( NVP ) - resistant variants have been associated with virologic failure ( VF ) of initial NVP-based combination antiretroviral therapy ( cART ) in women with prior exposure to single-dose NVP ( sdNVP ) .
BACKGROUND	We investigated whether a similar association exists in women without prior sdNVP exposure .
METHODS	Pre-cART plasma was analyzed by allele-specific polymerase chain reaction to quantify NVP-resistant mutants in human immunodeficiency virus-infected African women without prior sdNVP who were starting first-line NVP-based cART in the OCTANE/A5208 trial 2 .
METHODS	Associations between NVP-resistant mutants and VF or death were determined and compared with published results from women participating in the OCTANE/A5208 trial 1 who had taken sdNVP and initiated NVP-based cART .
RESULTS	Pre-cART NVP-resistant variants were detected in 18 % ( 39/219 ) of women without prior sdNVP exposure , compared to 45 % ( 51/114 ) with prior sdNVP exposure ( P < .001 ) .
RESULTS	Among women without prior sdNVP exposure , 8 of 39 ( 21 % ) with NVP-resistant variants experienced VF or death vs 31 of 180 ( 17 % ) without such variants ( P = .65 ) ; this compares with 21 of 51 ( 41 % ) vs 9 of 63 ( 14 % ) among women with prior exposure ( P = .001 ) .
CONCLUSIONS	The risk of VF on NVP-based cART from NVP-resistant variants differs between sdNVP-exposed and - unexposed women .
CONCLUSIONS	This difference may be driven by drug-resistance mutations emerging after sdNVP exposure that are linked on the same viral genome .
BACKGROUND	NCT00089505 .

###22842368
BACKGROUND	Studies have shown that physical activity or exercise training may decrease the metabolic syndrome .
OBJECTIVE	The aim of the present study is to clarify the effect of combination exercise training on metabolic syndrome parameters in postmenopausal women with breast cancer .
METHODS	Twenty nine postmenopausal women ( 58.27 + / - 6.31 years ) with breast cancer were divided into two groups randomly as experimental group ( n = 14 ) and control group ( n = 15 ) .
METHODS	Subjects of experimental group were performed 15 weeks combination exercise training including walking ( 2 sessions per week ) and resistance training ( 2 sessions per week that was different from walking days ) .
METHODS	Before and after 15 weeks , fasting insulin and glucose , insulin resistance , high-density lipoprotein cholesterol ( HDL-C ) and triglyceride ( TG ) were calculated .
METHODS	Also , Vo2peak , rest heart rate ( RHR ) , systolic blood pressure ( SBP ) , body weight ( BW ) , body mass index ( BMI ) and waist to hip ratio ( WHR ) were measured in two groups .
METHODS	Mean values of two groups in pre and post test were compared by independent and paired t-test for all measurements ( P 0.05 ) .
RESULTS	Significant differences were observed for VO2peak , RHR , BW , BMI , WHR , SBP , fasting insulin and glucose , HDL-C and TG between experimental and control groups after 15 weeks ( P < 0.05 ) .
CONCLUSIONS	Combination exercise training can improve metabolic syndrome parameters in postmenopausal women with breast cancer .

###12375395
OBJECTIVE	To confirm the structure-modulating properties of ACS4-ACS6 in gonathrosis by measuring the modifications in minimum joint space width , the mean thickness and the mean surface of the cartilage in internal femorotibial function .
METHODS	This was a double blind prospective study versus placebo including 300 symptomatic patients with internal femorotibial gonathrosis .
METHODS	The measurements were made with a semi-automatic method validated from digitalized radiological images taken at two years in each patient .
RESULTS	There was an equal number of dropouts in the 2 groups ( 40 in the ACS4-ACS6 group and 41 in the placebo group ) .
RESULTS	After 2 years , there was a significant difference , with worsening of the affection in the placebo group .
RESULTS	In the group treated with ACS4-ACS6 , there was no significant variation in all the radiological parameters , which remained remarkably stable .
RESULTS	When comparing the 2 groups , the statistical analysis revealed a significant difference in the ACS4-ACS6 group with maintenance of the cartilage analyzed , not only in the intent-to-treat patients but also in the per protocol population .
CONCLUSIONS	ACS4-ACS6 is superior to the placebo with regard to the stabilization of minimum joint space width of the internal femorotibial articular space , the mean thickness and the surface .

###9624070
OBJECTIVE	To compare effectiveness and acceptability of early discharge to a hospital at home scheme with that of routine discharge from acute hospital .
METHODS	Pragmatic randomised controlled trial .
METHODS	Acute hospital wards and community in north of Bristol , with a catchment population of about 224 000 people .
METHODS	241 hospitalised but medically stable elderly patients who fulfilled criteria for early discharge to hospital at home scheme and who consented to participate .
METHODS	Patients ' received hospital at home care or routine hospital care .
METHODS	Patients ' quality of life , satisfaction , and physical functioning assessed at 4 weeks and 3 months after randomisation to treatment ; length of stay in hospital and in hospital at home scheme after randomisation ; mortality at 3 months .
RESULTS	There were no significant differences in patient mortality , quality of life , and physical functioning between the two arms of the trial at 4 weeks or 3 months .
RESULTS	Only one of 11 measures of patient satisfaction was significantly different : hospital at home patients perceived higher levels of involvement in decisions .
RESULTS	Length of stay for those receiving routine hospital care was 62 % ( 95 % confidence interval 51 % to 75 % ) of length of stay in hospital at home scheme .
CONCLUSIONS	The early discharge hospital at home scheme was similar to routine hospital discharge in terms of effectiveness and acceptability .
CONCLUSIONS	Increased length of stay associated with the scheme must be interpreted with caution because of different organisational characteristics of the services .

###15293418
OBJECTIVE	Incomplete infiltration of the demineralized collagen network may result in a weak zone within the hybrid layer and between the hybrid layer and dentin .
OBJECTIVE	The current study evaluates whether reducing the etching time to 5 s from the recommended 15 s or increasing it to 30 s has an effect on dentin bonding .
METHODS	108 extracted molars were assigned to 3 bonding agent groups ( n = 36 ) : ( a ) Single Bond ( SB ) , ( b ) One-Step ( OS ) , and ( c ) Syntac Single Component ( SSC ) .
METHODS	Each group was further divided into three subgroups ( n = 12 ) of different etching times : 5 , 15 , and 30 s. All groups were bonded with Z100 composite resin according to the manufacturer 's instructions .
METHODS	All specimens were thermocycled 300 times between + / -5 degrees C and + / -55 degrees C , and shear bond strength testing and mode of failure analysis were performed .
RESULTS	The bond strength of SB ( 5 s : 15.5 MPa + / - 4.4 ; 15 s : 16.5 MPa + / - 3.1 ; 30 s : 16.8 MPa + / - 3.2 ) and OS ( 5 s : 13.7 MPa + / - 1.8 ; 15 s : 12.4 MPa + / - 3.8 ; 30 s : 10.6 MPa + / - 3.8 ) showed no significant differences ( p < 0.05 ) for the different etching times .
RESULTS	For SSC , different etching times showed significant differences ( 5 s : 10.9 MPa + / - 1.8 ; 15 s : 7.5 MPa + / - 2.5 ; 30 s : 6.4 MPa + / - 2.1 ) .
RESULTS	The mode of failure for SB and OS was adhesive or mixed adhesive/cohesive .
RESULTS	For SSC , all failures were adhesive .
CONCLUSIONS	Etching times of less than 15 s do not seem to adversely affect bonding to dentin .

###22584263
OBJECTIVE	Aquaporins ( AQPs ) present in the epidermis are essential hydration-regulating elements controlling cellular water and glycerol transport .
OBJECTIVE	In this study , the potential of glyceryl glucoside [ GG ; alpha-D-glucopyranosyl-alpha - ( 1 - > 2 ) - glycerol ] , an enhanced glycerol derivative , to increase the expression of AQP3 in vitro and ex vivo was evaluated .
METHODS	In vitro studies with real-time RT-PCR and FACS measurements were performed to test the induction by GG ( 3 % w/v ) of AQP3 mRNA and protein in cultured human keratinocytes .
METHODS	GG-containing formulations were applied topically to volunteer subjects and suction blister biopsies were analyzed to assess whether GG ( 5 % ) could penetrate the epidermis of intact skin , and subsequently upregulate AQP3 mRNA expression and improve barrier function .
RESULTS	AQP3 mRNA and protein levels were significantly increased in cultured human keratinocytes .
RESULTS	In the studies on volunteer subjects , GG significantly increased AQP3 mRNA levels in the skin and reduced transepidermal water loss compared with vehicle-controlled areas .
CONCLUSIONS	GG promotes AQP3 mRNA and protein upregulation and improves skin barrier function , and may thus offer an effective treatment option for dehydrated skin .

###1922205
BACKGROUND	Osteoporosis among older women is a major public health problem .
BACKGROUND	We studied the effects of three approaches to the prevention of osteoporosis in women with low bone density .
METHODS	One hundred twenty postmenopausal women ( mean [ + / - SD ] age , 56 + / - 4 ) who were selected because they had low forearm bone density were enrolled in a double-blind , placebo-controlled , randomized study comparing the effects of an exercise regimen ( exercise group , n = 41 ) , exercise plus dietary calcium supplementation ( exercise-calcium group , n = 39 ) , and exercise plus continuous replacement of estrogen and progesterone ( exercise-estrogen group , n = 40 ) .
METHODS	Periodically during the two-year study period , we measured the women 's bone density at three forearm sites , measured indexes of calcium metabolism , and recorded symptom scores .
METHODS	A comparison group of 42 women ( mean age , 55.5 + / - 3.1 ) with normal bone density was also followed for two years .
RESULTS	Significant bone loss in the distal forearm occurred in the group with normal bone density ( control group ) and the exercise group ( change , -2.7 percent and -2.6 percent of the base-line value per year , respectively ) .
RESULTS	Bone loss at the distal forearm site was significantly lower in the exercise-calcium group ( -0.5 percent of the base-line value per year ) , and bone density increased at this site in the exercise-estrogen group ( +2.7 percent of the base-line value per year ) .
RESULTS	Bone loss at the median forearm site was significantly lower in the exercise-calcium group ( -1.3 percent of the base-line value per year ) than in the exercise group ( -2.4 percent ) , and bone density at this site increased significantly in the exercise-estrogen group ( +0.8 percent of the base-line value per year ) .
RESULTS	Breast tenderness occurred in 47 percent of the women in the exercise-estrogen group but in only 20 percent in the other two treatment groups .
RESULTS	Vaginal bleeding occurred at some time in 52 percent of the women who had not had a hysterectomy in the exercise-estrogen group , as compared with 11 percent and 12.5 percent , respectively , in the exercise and exercise-calcium groups .
CONCLUSIONS	In postmenopausal women with low bone density , bone loss can be slowed or prevented by exercise plus calcium supplementation or estrogen-progesterone replacement .
CONCLUSIONS	Although the exercise-estrogen regimen was more effective than exercise and calcium supplementation in increasing bone mass , it also caused more side effects .