Datasets:

clinicalnlplab

/

MS2_train

like 0

Follow

Clinical NLP Lab 23

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: & NA ; To increase cardiopulmonary arrest survival , the American Heart Association developed basic and advanced cardiac life support ( ACLS ) courses that expose participants to realistic learning situations . This experimental study compared results of two ACLS classes on measures of knowledge ( content exam ) and resuscitation skills ( performance exam ) . Both the control and experimental groups consisted of physicians , nurses , emergency medical technicians , respiratory therapists , and advanced health care providers . The control group used low‐fidelity simulation ( LFS ) ; the experimental group was exposed to enhanced realism via high‐fidelity simulation ( HFS ) . The findings showed a positive correlation between enhanced practice and learning but no significant correlation between posttest and skills test scores for the LFS and HFS groups . The HFS group did score higher on both cognitive and behavioral tests , but the difference was not statistically significant . Participants from both groups indicated satisfaction with their forms of simulation experience and course design . In addition , participants ' self‐confidence to care for a victim of cardiopulmonary arrest was increased after completing their course ; profession and work experience had no effect on responses . The largest difference noted was in verbal responses to course satisfaction . The experimental group stated that learning using HFS was enjoyable and adamantly recommended that ACLS should only be taught using HFS . Further study is required to assess if practicing beyond the course enhances short‐ and long‐term retention of ACLS techniques Objective : To compare the usefulness for training of a porcine model ( larynx , trachea , and pig skin ) and a manikin model using a Portex cricothyrotomy kit ( PCK ) . Methods : In a prospect i ve r and omised crossover trial , participants in the airway workshop performed crico-thyrotomy using a PCK on the porcine and manikin models ( Tracheostomy Trainer and Case ) . The porcine model was made with larynxes and trachea from freshly slaughtered pigs and covered with a piece of thinned pigskin stapled to a wooden board . Participants were asked to assess the following : reality of skin turgor ; difficulty with skin penetration , l and mark recognition and procedure ; reality of the model ; and preference for each model using a visual analogue scale ( VAS ) of 0–10 cm . The VAS scores for each model were compared . Results : 49 participants were included in the study . Mean ( SD ) VAS scores for the reality of skin turgor , degree of difficulty with skin penetration and l and mark recognition were higher with the porcine model than with the manikin model ( 7.0 ( 2.1 ) vs 4.7 ( 2.0 ) , 6.4 ( 2.4 ) vs 3.6 ( 2.2 ) , 5.1 ( 2.2 ) vs 4.2 ( 2.5 ) , respectively ) . There was no difference between the models in the difficulty of the procedure ( 5.0 ( 2.4 ) vs 4.7 ( 3.2 ) ) . The porcine model had a higher VAS score for overall reality and preference of the model ( 7.1 ( 2.0 ) vs 4.8 ( 2.3 ) and 7.1 ( 2.0 ) vs 4.8 ( 2.2 ) , respectively ) . Conclusion : The porcine model is a more useful training tool than the manikin model for cricothyrotomy with PCK because of its reality and similarity to human anatomy Traditional teaching of laryngoscopy is difficult due to the trainer and trainee lacking a shared view . The Karl Storz BERCI DCI ® Video Laryngoscope provides a video image for the trainer and a direct view identical to that of a st and ard laryngoscope for the trainee . Forty‐nine novice subjects were r and omly assigned to a control group ( n = 24 ) taught using a st and ard Macintosh laryngoscope or a study group ( n = 25 ) taught using the Video Laryngoscope . Following training all subjects were assessed using a st and ard laryngoscope . Under simulated difficult airway conditions the study group performed better in terms of number of attempts ( p = 0.02 ) , number of repositioning manoeuvres required ( p = 0.046 ) and teeth trauma ( p = 0.034 ) . The study group were more confident of the success of their tube placement ( p = 0.035 ) , found it easier than the control group ( p = 0.042 ) and had improved knowledge of airway anatomy ( p = 0.011 ) . We conclude that video laryngoscopy confers benefits in the teaching of tracheal intubation OBJECTIVE : Poor communication and teamwork may contribute to errors during neonatal resuscitation . Our objective was to evaluate whether interns who received a 2-hour teamwork training intervention with the Neonatal Resuscitation Program ( NRP ) demonstrated more teamwork and higher quality resuscitations than control subjects . METHODS : Participants were noncertified 2007 and 2008 incoming interns for pediatrics , combined pediatrics and internal medicine , family medicine , emergency medicine , and obstetrics and gynecology ( n = 98 ) . Pediatrics and combined pediatrics/internal medicine interns were eligible for 6-month follow-up ( n = 34 ) . A r and omized trial was conducted in which half of the participants in the team training arm practice d NRP skills by using high-fidelity simulators ; the remaining practice d with low-fidelity simulators , as did control subjects . Blinded , trained observers viewed video recordings of high-fidelity – simulated resuscitations for teamwork and resuscitation quality . RESULTS : High-fidelity training ( HFT ) group had higher teamwork frequency than did control subjects ( 12.8 vs 9.0 behaviors per minute ; P < .001 ) . Intervention groups maintained more workload management ( control subjects : 89.3 % ; low-fidelity training [ LFT ] group : 98.0 % [ P < .001 ] ; HFT group : 98.8 % ; HFT group versus control subjects [ P < .001 ] ) and completed resuscitations faster ( control subjects : 10.6 minutes ; LFT group : 8.6 minutes [ P = .040 ] ; HFT group : 7.4 minutes ; HFT group versus control subjects [ P < .001 ] ) . Overall , intervention teams completed the resuscitation an average of 2.6 minutes faster than did control subjects , a time reduction of 24 % ( 95 % confidence interval : 12%–37 % ) . Intervention groups demonstrated more frequent teamwork during 6-month follow-up resuscitations ( 11.8 vs 10.0 behaviors per minute ; P = .030 ) . CONCLUSIONS : Trained participants exhibited more frequent teamwork behaviors ( especially the HFT group ) and better workload management and completed the resuscitation more quickly than did control subjects . The impact on team behaviors persisted for at least 6 months . Incorporating team training into the NRP curriculum is a feasible and effective way to teach interns teamwork skills . It also improves simulated resuscitation quality by shortening the duration Current Advanced Cardiac Life Support ( ACLS ) course instruction involves a 2-day course with traditional lectures and limited team interaction . We wish to explore the advantages of a scenario-based performance-oriented team instruction ( SPOTI ) method to implement core ACLS skills for non-English-speaking international paramedic students . The objective of this study was to determine if scenario-based , performance-oriented team instruction ( SPOTI ) improves educational outcomes for the ACLS instruction of Korean paramedic students . Thirty Korean paramedic students were r and omly selected into two groups . One group of 15 students was taught the traditional ACLS course . The other 15 students were instructed using a SPOTI method . Each group was tested using ACLS megacode examinations endorsed by the American Heart Association . All 30 students passed the ACLS megacode examination . In the traditional ACLS study group an average of 85 % of the core skills were met . In the SPOTI study group an average of 93 % of the core skills were met . In particular , the SPOTI study group excelled at physical examination skills such as airway opening , assessment of breathing , signs of circulation , and compression rates . In addition , the SPOTI group performed with higher marks on rhythm recognition compared to the traditional group . The traditional group performed with higher marks at providing proper drug dosages compared to the SPOTI students . However , the students enrolled in the SPOTI method result ed in higher megacode core compliance scores compared to students trained in traditional ACLS course instruction . These differences did not achieve statistical significance due to the small sample size BACKGROUND Recent literature describes \" cognitive dispositions to respond \" ( CDRs ) that may lead physicians to err in their clinical reasoning . OBJECTIVES To assess learner perception of high-fidelity mannequin-based simulation and debriefing to improve underst and ing of CDRs . METHODS Emergency medicine ( EM ) residents were exposed to two simulations design ed to bring out the CDR concept known as \" vertical line failure . \" Residents were then block-r and omized to a technical/knowledge debriefing covering the medical subject matter or a CDR debriefing covering vertical line failure . They then completed a written survey and were interviewed by an ethnographer . Four investigators blinded to group assignment review ed the interview transcripts and coded the comments . The comments were qualitatively analyzed and those upon which three out of four raters agreed were quantified . A r and om sample of 84 comments was assessed for interrater reliability using a kappa statistic . RESULTS Sixty-two residents from two EM residencies participated . Survey results were compared by technical ( group A , n = 32 ) or cognitive ( group B , n = 30 ) debriefing . There were 255 group A and 176 group B comments quantified . The kappa statistic for coding the interview comments was 0.42 . The CDR debriefing group made more , and qualitatively richer , comments regarding CDR concepts . The technical debriefing group made more comments on the medical subjects of cases . Both groups showed an appreciation for the risk of diagnostic error . CONCLUSIONS Survey data indicate that technical debriefing was better received than cognitive debriefing . The authors theorize that an underst and ing of CDRs can be facilitated through simulation training based on the analysis of interview comments OBJECTIVE To compare the ' 4-stage ' teaching technique ( demonstration , deconstruction , formulation , performance ) with the traditional ' 2-stage ' teaching technique ( deconstruction , performance ) in laryngeal mask airway ( LMA ) insertion . METHODS Using a prospect i ve r and omised study design , participants were taught LMA insertion on a manikin by either the ' 2-stage ' or ' 4-stage ' teaching method . Subjects were eligible if they had never inserted a LMA . Skill acquisition was assessed immediately following training , and skill retention assessed a number of weeks later . The primary outcome was LMA insertion on a manikin , with successful ventilation within 30 s. Other outcomes included overall time to LMA insertion , and number of errors . Assessors were blinded to the teaching method used for each subject . RESULTS A total of 120 participants were r and omised between the two teaching groups ( 60 subjects in each group ) . Mean time to LMA insertion at acquisition was 39.7 s for 2-stage and 34.7 s for 4-stage ( p>0.05 ) , and proportion completing within 30 s was 41.67 % for 2-stage and 48.33 % for the 4-stage teaching group ( p>0.05 ) . With skill retention assessment , mean time to LMA insertion was 44.3 s for 2-stage and 42.5 s for the 4-stage teaching group ( p>0.05 ) . Proportion completing task within 30 s was 34.0 % for 2-stage and 41.67 % for 4-stage group ( p>0.05 ) . Overall , there was no significant difference found in skill acquisition or in skill retention between the 2 or 4-stage teaching method . CONCLUSION The 2-stage teaching technique is not statistically different to the 4-stage teaching method in efficacy of LMA insertion skill acquisition or retention OBJECTIVES The objective of the study was to compare the learning and retention rates of resident physicians trained in posterior epistaxis management with nasal gauze packing on a simulation model following two training methods . METHODS This was a prospect i ve , repeated- measures study . An objective , criterion-referenced performance st and ard , consisting of the number of major steps completed in the proper sequence , and the number of minor steps completed within a specified time , was used by an evaluator to assess performances . Subjects underwent two pretraining assessment s 1 week prior to and the day of training and then were r and omized to one of two training methods : the traditional \" observation \" method or a \" pause- and -perfect \" method . After training , both groups repeated the procedure until meeting the performance st and ard . Subjects were retested 1 and 3 months after training . RESULTS Twenty-eight subjects participated . Baseline performance measures were similar between groups and did not change prior to training . During performance testing , experimental subjects completed a greater percentage of major steps ( 84 % ) and minor steps ( 86 % ) in less time ( 25 minutes ) than the controls ( 65 and 68 % , in 35 minutes ) during the first attempt . All subjects met the st and ard within three attempts . There were no differences in major and minor steps completed between the two groups at either 1 week or 3 months after training , but performance times were shorter in the experimental group . After 3 months , 13 % of control and none of experimental subjects met the performance st and ard . CONCLUSIONS The pause- and -perfect training method produced more rapid progress toward a performance st and ard during the initial attempt and better performance times after 3 months than the traditional , observational training method . Without further practice , this skill deteriorated after 3 months with both methods of training Introduction : Major resuscitation councils endorse the use of \n Output:\n " }, { "from": "agent", "value": "Qualitative comparisons of different simulation curricula are limited , although feedback , mastery learning , and higher fidelity were associated with improved learning outcomes .\nCONCLUSIONS Technology-enhanced simulation for EM learners is associated with moderate or large favorable effects in comparison with no intervention and generally small and nonsignificant benefits in comparison with other instruction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —The prevalence of obesity in both adults and children is increasing rapidly . Obesity in children is independently associated with arterial endothelial dysfunction and wall thickening , key early events in atherogenesis that precede plaque formation . Methods and Results —To evaluate the reversibility of obesity-related arterial dysfunction and carotid intima-media thickening by dietary and /or exercise intervention programs , 82 overweight children ( body mass index , 25±3 ) , 9 to 12 years of age , were r and omly assigned to dietary modification only or diet plus a supervised structured exercise program for 6 weeks and subsequently for 1 year . The prospect ively defined primary end points were ultrasound-derived arterial endothelial function ( endothelium-dependent dilation ) of the brachial artery and intima-media thickness of common carotid artery . At 6 weeks , both interventions were associated with decreased waist-hip ratio ( P < 0.02 ) and cholesterol level ( P < 0.05 ) as well as improved arterial endothelial function . Diet and exercise together were associated with a significantly greater improvement in endothelial function than diet alone ( P = 0.01 ) . At 1 year , there was significantly less thickening of the carotid wall ( P < 0.001 ) as well as persistent improvements in body fat content and lipid profiles in the group continuing an exercise program . Vascular function was significantly better in those children continuing exercise ( n=22 ) compared with children who withdrew from the exercise program ( n=19 ) ( P < 0.05 ) . Conclusions —Obesity-related vascular dysfunction in otherwise healthy young children is partially reversible with diet alone or particularly diet combined with exercise training at 6 weeks , with sustained improvements at 1 year in those persisting with diet plus regular exercise We report 10-year treatment outcomes for obese children in 4 r and omized treatment studies . At 10 years , 34 % decreased percentage overweight by 20 % or more , and 30 % were not obese . Significant effects were observed when parents and children were targeted and reinforced for weight loss in comparison with nontargeted controls and for children given lifestyle or aerobic exercise in comparison with a calisthenics control . Thirty-four percent of the variance in change in percentage overweight was predicted from sex , baseline percentage overweight , self-monitoring weight , meals eaten at home , and family and friends ' support for eating and exercise . Results show long-term changes in children depend on the treatment , and evidence converges on the importance of the family and other sources of support for eating and activity change OBJECTIVE The purpose of this pilot novel chiropractic health education intervention was to gather preliminary evidence regarding possible benefits from recreational youth soccer and nutrition education in overweight women . A secondary purpose was to determine whether some nutrition knowledge is an independent predictor of changes in body mass index ( BMI ) . METHODS A quiz developed and vali date d on separate age and sex appropriate blinded cohorts was used on study participants -22 volunteers of 57 eligible fourth- grade , overweight female Mississippi public school students . At the beginning of a 5-month study period , a 15-minute baseline nutrition intervention , grounded in Social Cognitive Theory and based on the United States Department of Agriculture 's \" My Tips for Families \" information , was applied in a chiropractic clinic . Subjects were then r and omized to 2 months of recreational soccer ( n = 14 ) or waiting list control ( n = 8) . RESULTS No preintervention differences were found in height , weight , BMI , or age . Higher follow-up BMI scores were found in both groups , and no significant differences between groups were found , possibly because of the small sample sizes and the short 8-week soccer intervention period . Gains in nutrition knowledge were sustained ( P < .002 ) ; however , there was no association between nutrition knowledge and follow-up BMI ( r = -.185 ; P < .462 ) . CONCLUSIONS Minimal nutrition education alone may be an ineffective intervention for overweight children . The study provides an example of how youth soccer may benefit overweight children The role of insulin in the regulation of blood pressure was evaluated in 50 obese adolescents before and after a 20-week weight loss program . When compared with 10 nonobese adolescents , the obese subjects had significantly higher systolic , diastolic , and mean arterial pressures ( p = 0.005 ) , an elevated 24-hour urinary sodium excretion ( p = 0.002 ) , an elevated fasting insulin concentration ( p = 0.001 ) , and an abnormal insulin response to an oral glucose tolerance test ( sum of the insulins at 0 , 1 , and 2 hours post-oral glucose load ; p = 0.001 ) . We also observed a significant correlation between systolic and diastolic blood pressure ( age and sex normalized ) and body weight ( r = 0.57 , p less than 0.01 and r = 0.7 , p less than 0.01 ) , fasting insulin ( r = 0.49 , p less than 0.01 and r = 0.54 , p less than 0.01 ) , and sum of insulins ( r = 0.42 , p less than 0.01 and r = 0.46 , p less than 0.01 ) . To study the effect of weight loss on the relationship between blood pressure and insulin , the obese subjects were r and omly assigned to three groups : 15 to a diet and behavior change group , 18 to a diet , behavior change , and exercise group , and 17 to an obese control group . Compared with the obese control group , the two weight loss groups each experienced a significant decrease in insulin ( p less than 0.01 ) , sum of the insulins ( p less than 0.01 ) , and blood pressure ( p less than 0.01 ) . The decrease in blood pressure during the weight loss program significantly correlated with the change in both insulin and body weight . ( ABSTRACT TRUNCATED AT 250 WORDS Background —The effects of diet and diet plus exercise training on muscle vasodilatation during physiological maneuvers in obese children are unknown . We tested the hypothesis that ( 1 ) blood pressure ( BP ) and forearm vascular conductance ( FVC ) responses during h and grip exercise and mental stress would be altered in obese children and ( 2 ) diet plus exercise training would restore BP and FVC responses during exercise and mental stress in obese children . Methods and Results —Thirty-nine obese children ( aged 10±0.2 years ) were r and omly divided into 2 groups : diet plus exercise training ( n=21 ; body mass index [ BMI ] = 28±0.5 kg/m2 ) and diet ( n=18 ; BMI = 30±0.4 kg/m2 ) . Ten age-matched lean control children ( BMI = 17±0.5 kg/m2 ) were also studied . Forearm blood flow was measured by venous occlusion plethysmography . BP was monitored noninvasively . H and grip exercise was performed at 30 % maximal voluntary contraction for 3 minutes . Stroop color word test was performed for 4 minutes . Baseline BP was significantly higher and FVC was significantly lower in obese children . During exercise and mental stress , BP responses were significantly higher and FVC responses were significantly lower in obese children . Diet and diet plus exercise training significantly reduced body weight . Diet and diet plus exercise training significantly decreased BP levels during exercise and mental stress . Diet plus exercise training , in contrast to diet alone , significantly increased FVC responses during exercise ( 3.7±0.3 versus 5.6±0.4 U ; P=0.01 ) and mental stress ( 3.5±0.5 versus 4.5±0.4 U ; P=0.02 ) . After diet plus exercise training , BP and FVC responses during exercise and mental stress were similar between obese children and the control group . Conclusions —Obesity exacerbates BP responses and impairs FVC responses during exercise and mental stress in children . Diet and exercise training restore BP and FVC responses in obese children Aims : To evaluate effects of a low energy diet , with or without strength training , on blood lipid profile in obese children . Methods : Eighty two obese children were enrolled into a six week dietary programme , and were r and omly allocated to a training group or a non-training group . The training group underwent regular exercise sessions with emphasis on strength training . Results : Height increased significantly , with a non-significant reduction in body mass index . Fat free mass increased significantly in the training group . Serum total cholesterol was significantly reduced in both groups . The LDL : HDL ratio significantly decreased in the training group . Conclusion : Results support the potentially beneficial effects of both diet and physical training . Further and longer term evaluation of such programmes is required PURPOSE To date , no study has examined the synergistic effects of a nutrition and combination of aerobic and strength training ( CAST ) on both adiposity and metabolic parameters in overweight Latina adolescent females . The goal was to assess if a 16-wk nutrition plus CAST pilot study had stronger effects on reducing adiposity and on improving glucose/insulin indices compared with control ( C ) , nutrition only ( N ) , and a nutrition plus strength training ( N + ST ) groups . METHODS In a 16-wk r and omized trial , 41 overweight Latina girls ( 15.2 + /- 1.1 yr ) were r and omly assigned to C ( n = 7 ) , N ( n = 10 ) , N + ST ( n = 9 ) , or N + CAST ( n = 15 ) . All intervention groups received modified carbohydrate nutrition classes ( once a week ) , whereas the N + ST also received strength training ( twice a week ) and the N + CAST received a combination of strength and aerobic training ( twice a week ) . The following were measured before and after intervention : strength by one repetition maximum , physical activity by the 7-d accelerometry and the 3-d physical activity recall , dietary intake by 3-d records , body composition by dual-energy x-ray absorptiometry ( DEXA ) , glucose/insulin indices by oral glucose tolerance test , and intravenous glucose tolerance test with minimal modeling . Across intervention group , effects were tested using ANCOVA with post hoc pairwise comparisons . RESULTS There were significant overall intervention effects for all adiposity measures ( weight , body mass index [ BMI ] , BMI z-scores , and DEXA total body fat ) , with a decrease of 3 % in the N + CAST group compared with a 3 % increase in the N + ST group ( P < or = 0.05 ) . There was also an intervention effect for fasting glucose with the N group increasing by 3 % and the N + CAST group decreasing by 4 % ( P < or = 0.05 ) . CONCLUSION The CAST was more effective than nutrition alone or nutrition plus strength training for reducing multiple adiposity outcomes and fasting glucose in overweight Latina girls . However , further research investigating and identifying intervention approaches that improve both adiposity and insulin indices , particularly in high-risk population s , are warranted OBJECTIVE To evaluate whether a child-centered physical activity program , combined with a parent-centered dietary program , was more efficacious than each treatment alone , in preventing unhealthy weight-gain in overweight children . STUDY DESIGN An assessor-blinded r and omized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children . Participants were r and omly assigned to 1 of 3 interventions : a parent-centered dietary program ( Diet ) ; a child-centered physical activity program ( Activity ) ; or a combination of both ( Diet+Activity ) . All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls . Analysis was by intention-to-treat . The primary outcome was change in body mass index z-score at 6 and 12 months ( n=114 and 106 , respectively ) . RESULTS Body mass index z-scores were reduced at 12-months in all groups , with the Diet ( mean [ 95 % confidence interval ] ) ( -0.39 [ -0.51 to 0.27 ] ) and Diet + Activity ( -0.32 , [ -0.36 , -0.23 ] ) groups showing a greater reduction than the Activity group ( -0.17 [ -0.28 , -0.06 ] ) ( P=.02 ) . Changes in other outcomes ( waist circumference and metabolic profile ) were not statistically significant among groups . CONCLUSION Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program , a parent-centered dietary program , or both . The greatest effect was achieved when a parent-centered dietary component was included The purpose of this study was to test the hypothesis that in obese children : 1 ) Ventilatory efficiency ( VentE ) is decreased during grade d exercise ; and 2 ) Weight loss through diet alone ( D ) improves VentE , and 3 ) diet associated with exercise training ( DET ) leads to greater improvement in VentE than by D. Thirty-eight obese children ( 10+/-0.2 years ; BMI > 95th percentile ) were r and omly divided into two study groups : D ( n=17 ; BMI = 30+/-1 kg/m ( 2 ) ) and DET ( n=21 ; 28+/-1 kg/m ( 2 ) ) . Ten lean children were included in a control group ( 10+/-0.3 years ; 17+/-0.5 kg/m ( 2 ) ) . All children performed maximal treadmill \n Output:\n " }, { "from": "agent", "value": "Based on the small number of short-term trials currently available , both diet-only and diet plus exercise interventions result ed in weight loss and metabolic profile improvement .\nThe diet-only intervention caused greater reductions in levels of triglycerides ( at the end of active intervention ) and low-density lipoprotein cholesterol ( at subsequent follow-up ) .\nAND RELEVANCE This review provides insights into the impact of dietary and exercise interventions on metabolic risk reduction in the pediatric population ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims : The aim of this study was to evaluate the effect of combined resistance and home-based walking exercise on glycemic and metabolic control , depression and quality of life in type-2 diabetes patients . Methods : This prospect i ve study was conducted at a private hospital in Turkey . Thirty-six type-2 diabetic patients participated in the study . Subjects were r and omly distributed in one 8 week exercise intervention or in one control group . Exercise program consisted of resistance training and home-based walking . Before and after the training program , muscular strength , fasting blood glucose , hemoglobin A1C , ( HbA1C ) and plasma lipid values , quality of life and symptoms of depression of the patients were assessed . Results : Exercise group 's baseline HbA1C was significantly higher than the control groups ( p < 0.05 ) ; other blood parameters were similar between the two groups ( p>0.05 ) . At the baseline no significant differences were observed in the depression and four subscales ( physical function , physical role , bodily pain , and general health perceptions ) of the SF-36 between the exercise and control groups ( p>0.05 ) . The exercise group had higher scores of emotional role , vitality and mental health subscales than the control groups after the training programs ( p<0.05 ) . Conclusion : Exercise training which included resistance training and home- based walking could be safe , effective and beneficial in diabetic patients BACKGROUND Regular physical exercise may improve a variety of physiological and psychological factors in depressive persons . However , there is little experimental evidence to support this assumption for adolescent population s. We conducted a r and omized controlled trial to investigate the effect of physical exercise on depressive state , the excretions of stress hormones and physiological fitness variables in adolescent females with depressive symptoms . METHODS Forty-nine female volunteers ( aged 18 - 20 years ; mean 18.8 + /- 0.7 years ) with mild-to-moderate depressive symptoms , as measured by the Centre for Epidemiologic Studies Depression ( CES-D ) scale , were r and omly assigned to either an exercise regimen or usual daily activities for 8 weeks . The subjects were then crossed over to the alternate regimen for an additional 8-week period . The exercise program consisted of five 50-min sessions per week of a group jogging training at a mild intensity . The variables measured were CES-D rating scale , urinary cortisol and epinephrine levels , and cardiorespiratory factors at rest and during exercise endurance test . RESULTS After the sessions of exercise the CES-D total depressive score showed a significant decrease , whereas no effect was observed after the period of usual daily activities ( ANOVA ) . Twenty-four hour excretions of cortisol and epinephrine in urine were reduced due to the exercise regimen . The training group had a significantly reduced resting heart rate and increased peak oxygen uptake and lung capacity . CONCLUSIONS The findings of this study suggest that a group jogging exercise may be effective in improving depressive state , hormonal response to stress and physiological fitness of adolescent females with depressive symptoms Background Depression is a disabling , prevalent condition . Physical activity programs may assist depression management in older people , ameliorate co-morbid conditions and reduce the need for antidepressants . The UPLIFT pilot study assessed the feasibility of older depressed people attending a community-based progressive resistance training ( PRT ) program . The study also aim ed to determine whether PRT improves depressive status in older depressed patients . Methods A r and omised controlled trial was conducted . People aged ≥ 65 years with depressive symptoms were recruited via general practice s. Following baseline assessment , subjects were r and omly allocated to attend a local PRT program three times per week for 10 weeks or a brief advice control group . Follow-up assessment of depressive status , physical and psychological health , functional and quality of life status occurred post intervention and at six months . Results Three hundred and forty six people responded to the study invitation , of whom 22 % had depressive symptoms ( Geriatric Depression Scale , GDS-30 score ≥ 11 ) . Thirty two people entered the trial . There were no significant group differences on the GDS at follow-up . At six months there was a trend for the PRT intervention group to have lower GDS scores than the comparison group , but this finding did not reach significance ( p = 0.08 ) . More of the PRT group ( 57 % ) had a reduction in depressive symptoms post program , compared to 44 % of the control group . It was not possible to discern which specific components of the program influenced its impact , but in post hoc analyses , improvement in depressive status appeared to be associated with the number of exercise sessions completed ( r = -0.8 , p < 0.01 ) . Conclusion The UPLIFT pilot study confirmed that older people with depression can be successfully recruited to a community based PRT program . The program can be offered by existing community-based facilities , enabling its ongoing implementation for the potential benefit of other older people BACKGROUND Although exercise has been shown to relieve depression , little is known about its mechanism or dose-response characteristics . We hypothesized that high intensity progressive resistance training ( PRT ) would be more effective than either low intensity PRT or st and ard care by a general practitioner ( GP ) in depressed elderly persons , and that high intensity PRT would provide superior benefits in quality of life , sleep quality , and self-efficacy . METHODS Sixty community-dwelling adults > 60 years with major or minor depression were r and omized to supervised high intensity PRT ( 80 % maximum load ) or low intensity PRT ( 20 % maximum load ) 3 days per week for 8 weeks , or GP care . RESULTS A 50 % reduction in the Hamilton Rating Scale of Depression score was achieved in 61 % of the high intensity , 29 % of the low intensity , and 21 % of the GP care group ( p = .03 ) . Strength gain was directly associated with reduction in depressive symptoms ( r = 0.40 , p = .004 ) , as was baseline social support network type ( F = 3.52 , p = .015 ) , whereas personality type , self-efficacy , and locus of control were unrelated to the antidepressant effect . Vitality quality -of-life scale improved more in the high intensity group than in the others ( p = .04 ) . Sleep quality improved significantly in all participants ( p < .0001 ) , with the greatest relative change in high intensity PRT ( p = .05 ) . CONCLUSIONS High intensity PRT is more effective than is low intensity PRT or GP care for the treatment of older depressed patients Dance and movement therapy are consisted of music , easy exercises and sensorial stimulus and provide drugless treatment for the depression on low rates . In this study , it has been aim ed to examine the effect of dance over the depression . A total of 120 healthy male and female conservatory students ranged from 20 and 24 ages volunteered to participate in this study . They were divided r and omly into 1 of 2 groups : dance training group ( DTG ; N = 60 ) and control group ( CG ; N = 60 ) . A dance training program was applied to the subjects three days a week ( Tuesday , Thursday , and Saturday ) during 12 weeks . The subjects in the control group did not participate in the training and participated only in the pre and post test measurements . Beck Depression Scale was used for the pre and post test measurements of subjects . 12 weeks of dance training has been found to be effective on the depression levels of the subjects participating in the research as the training group ( p < 0.05 ) . The depression level of males and females before training has meaningfully decreased after 12 weeks of dance training ( p < 0.05 ) . When the depression levels of the subjects participated in research as the control group were separately evaluated for males and females , no meaningful change has been found in the depression levels during 12 weeks ( p > 0.05 ) . In conclusion , it has been seen that dance affects the depression levels of university students positively and decreases their depression levels CONTEXT Many observational studies have shown that physical activity reduces the risk of cognitive decline ; however , evidence from r and omized trials is lacking . OBJECTIVE To determine whether physical activity reduces the rate of cognitive decline among older adults at risk . DESIGN AND SETTING R and omized controlled trial of a 24-week physical activity intervention conducted between 2004 and 2007 in metropolitan Perth , Western Australia . Assessors of cognitive function were blinded to group membership . PARTICIPANTS We recruited volunteers who reported memory problems but did not meet criteria for dementia . Three hundred eleven individuals aged 50 years or older were screened for eligibility , 89 were not eligible , and 52 refused to participate . A total of 170 participants were r and omized and 138 participants completed the 18-month assessment . INTERVENTION Participants were r and omly allocated to an education and usual care group or to a 24-week home-based program of physical activity . MAIN OUTCOME MEASURE Change in Alzheimer Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog ) scores ( possible range , 0 - 70 ) over 18 months . RESULTS In an intent-to-treat analysis , participants in the intervention group improved 0.26 points ( 95 % confidence interval , -0.89 to 0.54 ) and those in the usual care group deteriorated 1.04 points ( 95 % confidence interval , 0.32 to 1.82 ) on the ADAS-Cog at the end of the intervention . The absolute difference of the outcome measure between the intervention and control groups was -1.3 points ( 95 % confidence interval,-2.38 to -0.22 ) at the end of the intervention . At 18 months , participants in the intervention group improved 0.73 points ( 95 % confidence interval , -1.27 to 0.03 ) on the ADAS-Cog , and those in the usual care group improved 0.04 points ( 95 % confidence interval , -0.46 to 0.88 ) . Word list delayed recall and Clinical Dementia Rating sum of boxes improved modestly as well , whereas word list total immediate recall , digit symbol coding , verbal fluency , Beck depression score , and Medical Outcomes 36-Item Short-Form physical and mental component summaries did not change significantly . CONCLUSIONS In this study of adults with subjective memory impairment , a 6-month program of physical activity provided a modest improvement in cognition over an 18-month follow-up period . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000136606 The present study evaluated the effectiveness of a short-term mind-body intervention program on improving the depressive mood of an adult community sample . Forty adult volunteers with various degrees of depressive mood were r and omly assigned to the experimental group ( Dejian Mind-Body Intervention , DMBI ) and control group ( Cognitive-Behavioral Therapy , CBT ) . For each group , a total of four 90-min weekly sessions were conducted . Treatment-related changes were measured using the Beck Depression Inventory ( BDI-II ) , an electroencephalographic indicator of positive affect ( i.e. , prefrontal activation asymmetry ) , and self-report ratings on physical health . Results indicated that both the DMBI and the CBT group demonstrated significant reduction in depressive mood . However , among individuals with moderate to severe depressive mood at baseline , only those in the DMBI but not the CBT group showed significant reduction in depressive mood . Besides , only the DMBI group demonstrated a significant increase in prefrontal activation asymmetry , suggesting increase in positive affect . While most psychological therapies for depressive mood normally take several months to show treatment effect , the present findings provided initial data suggesting that the DMBI was effective in improving depressive mood of community adults after 1 month of training OBJECTIVES Based on the model by Tsang et al. ( 2002 ) which summarized the etiological factors and consequences of depression in elderly with chronic physical illnesses , a r and omized clinical trial of a special form of Qigong ( The Eight Section Brocades ) was conducted to assess if it improved the biopsychosocial health of participants . DESIGN 50 geriatric patients in sub-acute stage of chronic physical illnesses were recruited and r and omly assigned into the intervention and control group . The intervention group was given a 12-week period of Qigong practice while the control group was given traditional remedial rehabilitation activities . RESULTS The intervention group participants expressed improvement in physical health , ADL , psychological health , social relationship , and health in general as reflected by scores of the Perceived Benefit Question naire and informal feedback . CONCLUSION Although results are not significant in the generalization measures , it may be due to small effect size , small sample size , and short intervention period . Although not all of the hypotheses are supported , this report shows that Qigong ( the Eight Section Brocades ) is promising as an alternative intervention for elderly with chronic physical illness to improve their biopsychosocial health . More systematic evaluation with larger sample size and longer period of intervention is now underway in Hong Kong . Results will be reported once available We examined the effects of two physical activity modes on depressive symptoms over a 5-year period among older adults and change in physical self-esteem as a mediator of changes in depressive symptoms . Formerly sedentary , older adults ( N = 174 ) were r and omly assigned into 6-month conditions of either walking or low-intensity resistance/flexibility training . Depressive symptoms and physical self-esteem were measured before and after the 6-month intervention , and 12 and 60 months after intervention initiation . Depressive symptoms scores were decreased immediately after the intervention , followed by a sustained reduction for 12 and 60 months after intervention initiation ; there was no differential pattern of change between the physical activity modes . Change in physical self-esteem predicted change in \n Output:\n " }, { "from": "agent", "value": "Exercise is moderately more effective than a control intervention for reducing symptoms of depression , but analysis of method ologically robust trials only shows a smaller effect in favour of exercise .\nWhen compared to psychological or pharmacological therapies , exercise appears to be no more effective , though this conclusion is based on a few small trials" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To investigate the effect of the augmentation of levodopa with part-time and full-time occlusion on visual acuity and to determine its late results in amblyopia . METHODS Seventy-two patients with amblyopia were prospect ively studied and r and omly distributed into groups A , B , and C consisting of 24 patients each . Group A patients received levodopa alone , group B received levodopa and part-time ( 3 hours/day ) occlusion , and group C received levodopa and full-time ( during all waking hours ) occlusion of the dominant eye . Levodopa 0.50 mg/kg body weight , with a 25 % fixed dose combination of carbidopa , was administered orally three times a day for 7 weeks . Snellen visual acuity and its logMAR equivalent were recorded before treatment , at weeks 1 , 3 , 5 , and 7 after starting treatment , and every 6 weeks for 1 year after the completion of treatment . RESULTS Fifty-three ( 74 % ) of the 72 patients had an improvement in visual acuity after treatment . Forty-four of the 53 patients with improved visual acuities completed 1-year post-treatment follow-up . Twenty-three ( 52 % ) of the 44 patients had a regression in visual acuity . CONCLUSION The augmentation of levodopa with part-time or full-time occlusion does not enhance the recovery of vision in amblyopia . Improved visual acuity after levodopa administration persists at least 1 year in almost half of patients after cessation of treatment . Addition of full-time occlusion to levodopa helps maintain improved visual acuity for a longer duration compared to levodopa alone or combined with part-time occlusion PURPOSE To determine the effectiveness of weekend atropine for severe amblyopia from strabismus , anisometropia , or both combined among children 3 to 12 years of age . METHODS We enrolled children into 2 prospect i ve , r and omized multicenter clinical trials of amblyopia therapy . Herein we report the results for severe amblyopia , 20/125 to 20/400 . In Trial 1 , 60 children 3 to 6 years of age ( mean , 4.4 years ) were r and omized to weekend atropine plus a plano lens or weekend atropine plus full spectacle correction for the sound eye . In Trial 2 , 40 children 7 to 12 years of age ( mean , 9.3 years ) were r and omized to weekend atropine or 2 hours of daily patching . The visual acuity outcome was assessed at 18 weeks in Trial 1 and 17 weeks in Trial 2 . RESULTS In Trial 1 , visual acuity improved by an average of 4.5 lines in the atropine plus correction group ( 95 % CI , 3.2 - 5.8 lines ) and 5.1 lines in the atropine plus plano lens group ( 95 % CI , 3.7 - 6.4 lines ) . In Trial 2 , visual acuity improved by an average of 1.5 lines in the atropine group ( 95 % CI , 0.5 - 2.5 lines ) and 1.8 lines in the patching group ( 95 % CI , 1.1 - 2.6 lines ) . CONCLUSIONS Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia . Improvement may be greater in younger children The authors previously showed that a single dose of levodopa improves the contrast sensitivity and decreases the size of fixation point scotomas in amblyopic patients . In the present study , they investigated the effect of levodopa after 1 wk of daily administration using a cross-over , double masked design . The decrease of fixation point scotomas was confirmed with automatic static perimetry . An improvement of visual acuity occurred in 70 % of the patients after 1 wk of levodopa administration compared to only 22 % in the authors ' previous study using one single dose . The improvements in visual acuities and visual fields persisted even after the levodopa administration was completed BACKGROUND amblyopia is a major cause of visual impairment in children . Our aim is to compare patching and atropine penalization for treatment of moderate amblyopia in 4 - 10 years old children . METHODS During 2004 - 2007 , in a r and omized clinical trial , 120 patients aged 4 - 10 years old with moderate amblyopia in the range of 20/40 -20/100 were enrolled . Subjects r and omized either to patch therapy or twice weekly atropine penalization in equal groups and were followed for 2 years . The success rate was defined as increment of 2 or more lines of visual acuity or final visual acuity of 20/25 or better . RESULTS The visual acuity in amblyopic eye improved from base line to a mean of 3.8 lines in patching group and mean of 3.7 lines in atropine group at the end of follow up . The average visual acuity in both groups was 0.5 Log MAR acuity that increased to 0.18 in patching group and 0.2 in atropine group . CONCLUSION Twice weekly atropine penalization could improve visual acuity of a magnitude like to improvement provided by patching in treatment of moderate amblyopia in patients aged 4 - 10 years The aim of this study was to investigate the effect of laser acupuncture on cerebral activation . Using functional magnetic imaging ( fMRI ) cortical activations during laser acupuncture at the left foot ( Bladder 67 ) and dummy acupuncture , were compared employing a block design in ten healthy male volunteers . All experiments were done on a 1.5 Tesla magnetic resonance scanner equipped with a circular polarized head coil . During laser acupuncture , we found activation in the cuneus corresponding to Brodmann Area ( BA ) 18 and the medial occipital gyrus ( BA 19 ) of the ipsilateral visual cortex . Placebo stimulation did not show any activation . We could demonstrate that laser acupuncture of a specific acupoint , empirically related to ophthalmic disorders , leads to activation of visual brain areas , whereas placebo acupuncture does not . These results indicate that fMRI has the potential to eluci date effects of acupuncture on brain activity OBJECTIVE To determine the visual acuity outcome at age 10 years for children younger than 7 years when enrolled in a treatment trial for moderate amblyopia . METHODS In a multicenter clinical trial , 419 children with amblyopia ( visual acuity , 20/40 - 20/100 ) were r and omized to patching or atropine eyedrops for 6 months . Two years after enrollment , a subgroup of 188 children entered long-term follow-up . Treatment after 6 months was at the discretion of the investigator ; 89 % of children were treated . MAIN OUTCOME MEASURE Visual acuity at age 10 years with the electronic Early Treatment Diabetic Retinopathy Study test . APPLICATION TO CLINICAL PRACTICE Patching and atropine eyedrops produce comparable improvement in visual acuity that is maintained through age 10 years . RESULTS The mean amblyopic eye acuity , measured in 169 patients , at age 10 years was 0.17 logMAR ( logarithm of the minimum angle of resolution ) ( approximately 20/32 ) , and 46 % of amblyopic eyes had an acuity of 20/25 or better . Age younger than 5 years at entry into the r and omized trial was associated with a better visual acuity outcome ( P < .001 ) . Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups ( P = .56 and P = .80 , respectively ) . CONCLUSIONS At age 10 years , the improvement of the amblyopic eye is maintained , although residual amblyopia is common after treatment initiated at age 3 years to younger than 7 years . The outcome is similar regardless of initial treatment with atropine or patching BACKGROUND Although amblyopia can be successfully treated with patching or atropine , there have been few prospect i ve studies of amblyopia recurrence once treatment is discontinued . METHODS We enrolled 156 children with successfully treated anisometropic or strabismic amblyopia ( 145 completed follow-up ) , who were younger than 8 years of age and who received continuous amblyopia treatment for the previous 3 months ( prescribed at least 2 hours of daily patching or prescribed at least one drop of atropine per week ) and who had improved at least 3 logMAR levels during the period of continuous treatment . Patients were followed off treatment for 52 weeks to assess recurrence of amblyopia , defined as a 2 or more logMAR level reduction of visual acuity from enrollment , confirmed by a second examination . Recurrence was also considered to have occurred if treatment was restarted because of a nonreplicated 2 or more logMAR level reduction of visual acuity . RESULTS Recurrence occurred in 35 ( 24 % ) of 145 cases ( 95 % confidence interval 17 % to 32 % ) and was similar in patients who stopped patching ( 25 % ) and in patients who stopped atropine ( 21 % ) . In patients treated with moderately intense patching ( 6 to 8 hours per day ) , recurrence was more common ( 11 of 26 ; 42 % ) when treatment was not reduced prior to cessation than when treatment was reduced to 2 hours per day prior to cessation ( 3 of 22 ; 14 % , odds ratio 4.4 , 95 % confidence interval 1.0 to 18.7 ) . CONCLUSIONS Approximately one fourth of successfully treated amblyopic children experience a recurrence within the first year off treatment . For patients treated with 6 or more hours of daily patching , our data suggest that the risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced to 2 hours per day prior to cessation . A r and omized clinical trial of no weaning versus weaning in successfully-treated amblyopia is warranted to confirm these observational findings Background and purpose : To date , much of the research regarding amblyopia has been focused on which therapeutic modality is the most efficacious in amblyopia management . Unfortunately , there is a lack of research into which method of treatment cessation is the most appropriate once therapy has been completed . The purpose of this study is to investigate if the cessation method affects the recurrence rate of amblyopia . Methods : This study was a prospect i ve r and omized clinical trial of 20 subjects who were wearing full-time occlusion and were at the end point of their therapy . The subjects were r and omized into one of two groups : abrupt cessation or therapy tapering . All subjects were followed for 3 consecutive 4-week intervals , for a total of 12 weeks , to assess the short-term recurrence rate of amblyopia . Subjects who were in the tapered group had their occlusion reduced from full-time occlusion ( all waking hours minus one ) to 50 % of waking hours at study enrollment ( i.e. , from 12 hours/day to 6 hours per day ) ; occlusion was reduced by an additional 50 % at the first 4-week study visit ( i.e. , from 6 hours/day to 3 hours ) , with occlusion being discontinued completely at the week 8 visit . All subjects who were in the abrupt cessation group had their full-time occlusion discontinued completely at the start of the study ( i.e. , from 12 hours/day to none ) . Additional assessment s were also conducted at week 26 and week 52 post – therapy cessation to determine the longer term amblyopia regression rate . For the purpose s of this study , recurrence was defined as a 0.2 ( 10 letters ) or more logarithm of the minimum angle of resolution ( logMAR ) loss of visual acuity . Results : A recurrence of amblyopia occurred in 4 of 17 ( 24 % ; CI 9%–47 % ) participants completing the study by the week 52 study end point . There were 2 subjects from each treatment group who demonstrated a study protocol –defined recurrence . Conclusion : There was a 24 % risk of amblyopia recurrence if therapy was discontinued abruptly or tapered in 8 weeks . In this small sample , the assigned cessation method did not affect the rate of amblyopia recurrence . It is recognized that the smaller sample size in our study prevents us from making definitive conclusions on the potential role that abrupt cessation has on the regression rate of amblyopia . The sample size was too small to reach an acceptable level of statistical power ; therefore the generalizability of the findings to the broad population of all patients with amblyopia requires continuing research . This study therefore could be considered as a pilot study Amblyopia is a developmental abnormality that results in physiological alterations in the visual cortex and impairs form vision . It is often successfully treated by patching the sound eye in infants and young children , but is generally considered to be untreatable in adults . However , a number of recent studies suggest that repetitive practice of a visual task using the amblyopic eye results in improved performance in both children and adults with amblyopia . These perceptual learning studies have used relatively brief periods of practice ; however , clinical studies have shown that the time-constant for successful patching is long . The time-constant for perceptual learning in amblyopia is still unknown . Here we show that the time-constant for perceptual learning depends on the degree of amblyopia . Severe amblyopia requires > 50 h ( ≈35,000 trials ) to reach plateau , yielding as much as a five \n Output:\n " }, { "from": "agent", "value": "This includes the finding that less intensive occlusion treatments can be successful in treating amblyopia .\nA relationship between adherence to treatment and visual acuity has also been established and has been shown to be influenced by the use of intervention material .\nIn addition , there is growing evidence of that a period of glasses wearing only can significantly improve visual acuity alone without any other modes of treatment ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Evidence from the USA suggests that the home-based Family Nurse Partnership program ( FNP ) , extending from early pregnancy until infants are 24 months , can reduce the risk of child abuse and neglect throughout childhood . FNP is now widely available in the UK . A new variant , Group Family Nurse Partnership ( gFNP ) offers similar content but in a group context and for a shorter time , until infants are 12 months old . Each group comprises 8 to 12 women with similar expected delivery date s and their partners . Its implementation has been established but there is no evidence of its effectiveness . Methods / Design The study comprises a multi-site r and omized controlled trial design ed to identify the benefits of gFNP compared to st and ard care . Participants ( not eligible for FNP ) must be either aged < 20 years at their last menstrual period ( LMP ) with one or more previous live births , or aged 20 to 24 at LMP with low educational qualifications and no previous live births . ‘ Low educational qualifications ’ is defined as not having both Maths and English Language GCSE at grade C or higher or , if they have both , no more than four in total at grade C or higher . Exclusions are : under 20 years and previously received home-based FNP and , in either age group , severe psychotic mental illness or not able to communicate in English . Consenting women are r and omly allocated ( minimized by site and maternal age group ) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to st and ard care after the collection of baseline information . Research ers are blind to group assignment . The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction . Secondary outcomes are maternal depression , parenting stress , health related quality of life , social support , and use of services . Discussion This is the first study of the effectiveness of gFNP in the UK . Results should inform decision-making about its delivery alongside universal services , potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting . Trial registration IS RCT N78814904 OBJECTIVE To study the effect of integrated yoga on Pregnancy experience , anxiety , and depression in normal pregnancy . METHODS This Prospect i ve R and omized control study recruited 96 women in 20th week of normal pregnancy . Yoga group ( n = 51 ) practice d integrated yoga and control group ( n = 45 ) did st and ard antenatal exercises , one hour daily , from 20th to 36th week of gestation . Mann-Whitney and Wilcoxon 's tests were used for statistical analysis . RESULTS There was significant difference between groups ( Mann-Whitney p < 0.001 ) in all variables . There were significant changes within groups ( Wilcoxon 's p < 0.001 ) in both groups . Pregnancy related experience ( PEQ ) reduced in yoga by 26.86 % , State ( STAI I ) anxiety ( decreased 15.65 % in yoga , increased 13.76 % in control ) , Trait ( STAI II ) anxiety ( decreased 8.97 % in yoga , increased 5.02 % in control ) and Depression ( HADS ) ( decreased 30.67 % in yoga , increased 3.57 % in control ) . CONCLUSION Yoga reduces anxiety , depression and pregnancy related uncomfortable experiences BACKGROUND Yoga may be well suited for depressed and anxious pregnant women , given reported benefits of meditation and physical activity and pregnant women 's preference for nonpharmacological treatments . METHODS We r and omly assigned 46 pregnant women with symptoms of depression and anxiety to an 8-week yoga intervention or treatment-as-usual ( TAU ) in order to examine feasibility and preliminary outcomes . RESULTS Yoga was associated with high levels of credibility and satisfaction as an intervention for depression and anxiety during pregnancy . Participants in both conditions reported significant improvement in symptoms of depression and anxiety over time ; and yoga was associated with significantly greater reduction in negative affect as compared to TAU ( β = -0.53 , SE = 0.20 , p = .011 ) . CONCLUSION Prenatal yoga was found to be a feasible and acceptable intervention and was associated with reductions in symptoms of anxiety and depression ; however , prenatal yoga only significantly outperformed TAU on reduction of negative affect BACKGROUND Postnatal and antenatal depression are a focus of considerable clinical and research attention , but little is known about the patterns of anxiety across this period . METHODS Self-reported anxiety and depression were assessed at 18 and 32 weeks gestation and 8 weeks and 8 months postnatally in a prospect i ve longitudinal study of a community sample of women in Engl and ( n=8323 ) . RESULTS The majority of cases of postnatal depression were preceded by antenatal depression ; similarly , postnatal anxiety was preceded by antenatal anxiety . Despite the stability of anxiety and depression across this period , there was a mean decrease in both anxiety and depression . Finally , antenatal anxiety predicted postnatal depression at 8 weeks and 8 months , even after controlling for antenatal depression ( OR=3.22 , p<0.001 ) . LIMITATIONS Data were based on self-report only and there was evidence of selective attrition . CONCLUSION The findings confirm that antenatal anxiety occurs frequently , overlaps with depression and increases the likelihood of postnatal depression Summary Stress and negative mood during pregnancy increase risk for poor childbirth outcomes and postnatal mood problems and may interfere with mother – infant attachment and child development . However , relatively little research has focused on the efficacy of psychosocial interventions to reduce stress and negative mood during pregnancy . In this study , we developed and pilot tested an eight-week mindfulness-based intervention directed toward reducing stress and improving mood in pregnancy and early postpartum . We then conducted a small r and omized trial ( n = 31 ) comparing women who received the intervention during the last half of their pregnancy to a wait-list control group . Measures of perceived stress , positive and negative affect , depressed and anxious mood , and affect regulation were collected prior to , immediately following , and three months after the intervention ( postpartum ) . Mothers who received the intervention showed significantly reduced anxiety ( effect size , 0.89 ; p < 0.05 ) and negative affect ( effect size , 0.83 ; p < 0.05 ) during the third trimester in comparison to those who did not receive the intervention . The brief and nonpharmaceutical nature of this intervention makes it a promising c and i date for use during pregnancy Background Poor recruitment and retention of participants in r and omised controlled trials ( RCTs ) is problematic but common . Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs . Despite improved reporting since the implementation of the CONSORT statement , important problems remain . This paper aims : ( i ) to up date and extend previous review s evaluating reporting of participant recruitment and retention in RCTs ; ( ii ) to quantify the level of participation throughout RCTs . Methods We review ed all reports of RCTs of health care interventions and /or processes with individual r and omisation , published July – December 2004 in six major journals . Short , secondary or interim reports , and Phase I/II trials were excluded . Data recorded were : general RCT details ; inclusion of flow diagram ; participant flow throughout trial ; reasons for non-participation/withdrawal ; target sample sizes . Results 133 reports were review ed . Overall , 79 % included a flow diagram , but over a third were incomplete . The majority reported the flow of participants at each stage of the trial after r and omisation . However , 40 % failed to report the numbers assessed for eligibility . Percentages of participants retained at each stage were high : for example , 90 % of eligible individuals were r and omised , and 93 % of those r and omised were outcome assessed . On average , trials met their sample size targets . However , there were some substantial shortfalls : for example 21 % of trials reporting a sample size calculation failed to achieve adequate numbers at r and omisation , and 48 % at outcome assessment . Reporting of losses to follow up was variable and difficult to interpret . Conclusion The majority of RCTs reported the flow of participants well after r and omisation , although only two-thirds included a complete flow chart and there was great variability over the definition of \" lost to follow up \" . Reporting of participant eligibility was poor , making assessment s of recruitment practice and external validity difficult . Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart This r and omised controlled pilot trial tested a six-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety . Forty-seven women enrolled between 10 and 25 weeks gestation were r and omly assigned to either a series of weekly Mindful Awareness Practice s classes ( n = 24 ) with home practice or to a reading control condition ( n = 23 ) . Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety ( PRA ) than participants in the reading control condition . However , these effects were not sustained through follow-up at six weeks post-intervention . Participants in both groups experienced increased mindfulness , as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods . This study is one of the first r and omised controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce PRA and worry . We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for research ers interested in conducting mind-body interventions during pregnancy Background National guidelines in the UK , United States of America , Canada , and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression . However , there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy . Research indicates the necessity to consider the unique needs and concerns of perinatal population s to ensure treatment engagement , highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services . This trial aims to develop a brief intervention for antenatal anxiety , with a focus on embedding the delivery of the treatment within routine antenatal care . Methods / Design This study is a two-phase feasibility trial . In phase 1 we will develop and pilot a brief intervention for antenatal anxiety , blended with group support , to be led by midwives . This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers . The intervention will then be tested in a pilot r and omised controlled trial in phase 2 . The following outcomes will be assessed : ( 1 ) number of participants meeting eligibility criteria , ( 2 ) number of participants consenting to the study , ( 3 ) number of participants r and omised , ( 4 ) number of sessions completed by those in the intervention arm , and ( 5 ) number of participants completing the post-intervention outcome measures . Secondary outcomes comprise : detailed feedback on acceptability , which will guide further development of the intervention ; and outcome data on symptoms of maternal and paternal anxiety and depression , maternal quality of life , quality of couple relationship , mother-child bonding , infant temperament and infant sleep . Discussion The study will provide important data to inform the design of a future full-scale r and omised controlled trial of a brief intervention for anxiety during pregnancy . This will include information on its acceptability and feasibility regarding implementation within current antenatal services , which will inform whether ultimately this provision could be rolled out widely in healthcare setting s . Trial registration Current Controlled Trials IS RCT N95282830 . Registered on 29 October 2014 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Mindfulness interventions to reduce psychological distress are well-suited to pregnancy , due to their brief and non-pharmacological nature , but there is a need for more robust evidence determining their usefulness . This pilot study was design ed to explore the feasibility of a r and omised controlled trial of a mindfulness intervention to reduce antenatal depression , anxiety and stress . Methods The study was design ed in two parts 1 ) a non-r and omised trial targeting women at risk of mental health problems ( a selected population ) and 2 ) a r and omised controlled trial ( RCT ) of a universal population . Process evaluation focused on feasibility of recruitment pathways , participant retention , acceptability of study measures , and engagement with mindfulness practice s. Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised , the Depression Anxiety and Stress Scale-21 , the State-Trait Anxiety Inventory , and the Perceived Stress Scale . Results 20 women were recruited to the non-r and omised trial , and 32 to the RCT . Recruitment through a mailed study brochure at the time of booking-in to the hospital result ed in the largest number of participants in the RCT ( 16/32 ; 50 % ) , and result ed in considerably earlier recruitment ( 50 % in first trimester , 50 % second trimester ) compared to recruitment through the antenatal clinic waiting room ( 86 % in second trimester , 14 % third trimester ) . Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety , indicating a sample with more symptom \n Output:\n " }, { "from": "agent", "value": "The State-Trait Anxiety Inventory was the most commonly used anxiety measure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Summary Methods that objective ly assess the muscle fibre-type arrangement may improve the detection of fibre-type grouping , a diagnostic sign of a denervation and reinnervation process . To distinguish between a diseased and a normal muscle , there is a need for quantitative data on the fibre-type arrangement in healthy human muscles at different ages . In this study , cross-sections were prepared of whole autopsied vastus lateralis muscle from 24 previously physically healthy men , aged 15 to 83 years . The arrangements of type 1 and type 2 fibres were assessed in terms of the number of enclosed fibres in individual fascicles throughout each muscle . Recent improvements to the enclosed fibre method were used to define measures of r and omness which facilitated the combination of several sample areas and the quantification of the fibre-type arrangements . Segregation was typical for young muscles , r and omness was most common between 30 and 50 years of age , while some fibre-type grouping was considered “ normal ” in old muscles . The arrangements of type 1 and type 2 fibres were quantitatively similar , irrespective of the age of the individual . The results imply that the fibre population changes considerably during a lifetime , and that it undergoes a continuous denervation and reinnervation process with normal ageing . Because of its importance , age should be accommo date d in the analysis of a muscle sample , irrespective of the statistical model and method used The present study was design ed to examine the finger-pinch force control , digit force sharing and digit coupling relations of 13 young and 14 older adults . Subjects performed four isometric tri-digit finger-pinch force production conditions reflecting all combinations of mean force level ( 20 and 40 % MVC ) and target shape ( constant and sinusoidal ) . Older adults had significantly reduced force control , as indicated by their greater levels of absolute and relative force variability and targeting error than young adults . The age-related loss of relative force control was more pronounced at low ( 20 % MVC ) than high ( 40 % MVC ) forces , and to a lesser extent , in sinusoidal than constant force conditions . Older adults had significantly greater peak and proportional power below 1.5 Hz than young adults , with this especially pronounced in constant force conditions . Digit force sharing results indicated that the index finger ’s contribution to total force was increased and the middle finger ’s contribution reduced in older than young adults . The results of the cross-correlation analyses revealed that older subjects had a significantly reduced level of coupling between the middle finger and the target force , thumb force and EMG signals , with longer time lags in comparison to young adults . These differences in force sharing and middle finger force coupling were more pronounced in sinusoidal than constant force conditions . Overall , these results suggest that the older adults ’ reduced force control reflected age-related differences in the sharing and coupling of the finger forces . The results also highlighted that tasks of this nature display a degree of task-dependency , with these overall differences in digit force output and coupling not consistently observed across all force conditions The purpose of this study was to investigate the effects of aging and the role of augmented visual information in the acquisition of a new bimanual coordination pattern , namely a 90 degrees relative phase pattern . In a pilot study , younger and older adults received augmented visual feedback in the form of a real-time orthogonal display of both limb movements after every fifth trial . Younger adults acquired this task over three days of practice and retained the task well over periods of one week and one month of no practice while the older adults showed no improvement at all on the task . It was hypothesized that the amount of augmented information was not sufficient for the older adults to overcome the strong tendency to perform natural , intrinsically stable coordination patterns , which consequently prevented them from learning the task . The present study evaluated the age-related role of augmented visual feedback for learning the new pattern . Participants were r and omly assigned within age groups to receive either concurrent or terminal visual feedback after every trial in acquisition . In contrast to the pilot study , all of the older adults learned the pattern , although not to the same level as the younger adults . Both younger and older adults benefitted from concurrent visual feedback , but the older adults gained more from the concurrent feedback than the younger adults , relative to terminal feedback conditions . The results suggest that when learning bimanual coordination patterns , older adults are more sensitive to the structure of the practice conditions , particularly the availability of concurrent visual information . This greater sensitivity to the learning environment may reflect a diminished capacity for inhibitory control and a decreased ability to focus attention on the salient aspects of learning the task \n Output:\n " }, { "from": "agent", "value": "These findings indicate that older adults displayed reduced accuracy , greater variability , and longer execution time when executing bimanual movements .\nConclusion : These meta‐analytic findings revealed that aging impairs bimanual movement performance .\nHighlightsPrevious bimanual movements and aging studies report conflicting results .Current meta‐ analysis revealed impaired bimanual movements in older adults .\nOlder adults showed less accuracy , more variability , and longer movement time" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction In this prospect i ve , r and omized controlled study , we aim ed to evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis . Material s and methods Forty-two patients with severe sepsis were enrolled in the study . Patients in the study group ( n = 21 ) received an intravenous immunoglobulin preparation ( Pentaglobin ® ) in addition to st and ard therapy . Pentaglobin ® therapy was commenced on the day of diagnosis of severe sepsis : 5 ml/kg per day Pentaglobin ® ( 38 g/l IgG , 6 g/l IgM , and 6 g/l IgA ) was infused over 6 hours and repeated for 3 consecutive days . Patients in the control group ( n = 18 ) received st and ard sepsis therapy , but no immunoglobulin administration . Blood sample s for procalcitonin ( PCT ) measurements were taken daily for 8 days . Severity of critical illness and development of organ failure were assessed by obtaining daily acute physiological and chronic health evaluation ( APACHE ) II and sequential organ failure assessment ( SOFA ) scores . Results and discussion Procalcitonin levels showed a statistically significant decrease in the Pentaglobin ® group ( P < 0.001 ) ; however , an improvement in SOFA scores could not be demonstrated . Procalcitonin levels and SOFA scores did not change significantly in the control group . Septic shock incidence ( 38 % versus 57 % ) and 28-day mortality rate ( 23.8 % versus 33.3 % ) were found to be similar between the Pentaglobin ® and control groups . The evaluation of serial APACHE II scores did not demonstrate a difference between Pentaglobin ® and control groups either . Conclusion Present data could not demonstrate any beneficial effects of polyclonal immunoglobulin preparation Pentaglobin ® on organ morbidity , septic shock incidence and mortality rate in patients with severe sepsis Objective : Intravenous immunoglobulin as an adjunctive treatment in sepsis was regarded as promising by a Cochrane meta‐ analysis of smaller trials . In this phase III multicenter trial , we assessed whether intravenous immunoglobulin G ( ivIgG ) reduced 28‐day mortality and improved morbidity in patients with score‐defined severe sepsis . Design : R and omized , double‐blind , placebo‐controlled , multicenter trial . Setting : Twenty‐three medical and surgical intensive care units in university centers and large teaching hospitals . Patients : Patients ( n = 653 ) with score‐defined sepsis ( sepsis score 12–27 ) and score‐defined sepsis‐induced severity of disease ( Acute Physiology and Chronic Health Evaluation II score 20–35 ) . Interventions : Patients were assigned to receive either placebo or ivIgG ( day 0 , 0.6 g/kg body weight ; day 1 , 0.3 g/kg body weight ) . Measurements and Main Results : The prospect ively defined primary end point was death from any cause after 28 days . Prospect ively defined secondary end points were 7‐day all‐cause mortality , short‐term change in morbidity , and pulmonary function at day 4 . Six hundred fifty‐three patients from 23 active centers formed the intention‐to‐treat group , 624 patients the per‐ protocol group ( placebo group , n = 303 ; ivIgG group , n = 321 ) . The 28‐day mortality rate was 37.3 % in the placebo group and 39.3 % in the ivIgG group and thus not significantly different ( p = .6695 ) . Seven‐day mortality was not reduced , and 4‐day pulmonary function was not improved . Drug‐related adverse events were rare in both groups . Exploratory findings revealed a 3‐day shortening of mechanical ventilation in the surviving patients and no effect of ivIgG on plasma levels of interleukin‐6 and tumor necrosis factor receptors I and II . Conclusions : In patients with score‐defined severe sepsis , ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality Objective : To evaluate the effect of intravenous IgMA-enriched immunoglobulin ( ivIGMA ) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock . Design : Multiple-center , prospect i ve r and omized , controlled study . Setting : Six university hospitals in Germany . Patients : Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999 . Interventions : Patients received 1300 mL of ivIGMA ( 7.8 g IgM , 7.8 g IgA , and 49.4 g IgG ) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA . Measurements and Main Results : All-cause mortality at 28 days , sepsis-related mortality at 28 days , all-cause mortality at 60 days , mortality from septic shock , and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded . Immunoglobulin had no benefit over human albumin . The 28-day mortality rate was 26.2 % and 28.2 % in the ivIGMA and control patients , respectively ( difference , 2.0 % [ 95 % confidence interval , −10.2 to 14.2 percentage points ] ) . Likewise , the 60-day mortality rate did not differ between both arms ( 29.6 % vs. 34.7 % in the ivIGMA and control patients , respectively ) . Mortality rates in patients with sepsis syndrome ( 17.1 % vs. 16.7 % ) and septic shock ( 51.9 % vs. 54.8 % ) were also found to be similar between both groups . Conclusions : Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock Thrombocytopenia frequently complicates systemic infection and results from multiple possible mechanisms . We and others have demonstrated that platelet-associated IgG ( PAIgG ) levels are elevated in the majority of patients with septic thrombocytopenia . Corticosteroids may be undesirable as a treatment for thrombocytopenia for patients with severe infection because of their potential for suppressing the immune response . We hypothesized that septic thrombocytopenia is , in most cases , an immune disorder analogous to idiopathic thrombocytopenic purpura ( ITP ) which might respond to intravenous gamma-globulin as a treatment for increasing the platelet count in this disorder . Intravenous immune globulin ( IVIG ) , 400 mg/kg daily for 3 days , was administered in a r and omized double-blind placebo-controlled trial . Twenty-nine patients who developed thrombocytopenia during a documented , septic episode were studied . Patients with disseminated intravascular coagulation ( DIC ) , hypersplenism , or drugs known to cause thrombocytopenia were excluded . Elevated PAIgG levels were documented in 52 % of evaluable patients . Mean platelet counts in the IVIG group rose from 43 K at study entry to 178 K ( 411 % rise ) by Day 9 . In the placebo group platelets rose from 51 K to 125 K ( 261 % rise;P = 0.02 ) . Seventy-seven percent of the IVIG group had a minimum peak rise of 35 K , vs 56 % of the placebo group . Three patients in the placebo group had a serious bleeding episode , vs one in the IVIG group . The use of IVIG to treat septic thrombocytopenia not associated with DIC leads to a more rapid , more sustained , and greater increase in platelet count than placebo . Its use is recommended in the septic patient who is bleeding or is likely to need invasive or surgical procedures The objective of this study was to assess the impact on outcome of adjuvant therapy ( high-dose of immunoglobulin [ Ig ] M-enriched intravenous Ig , IVIG ) in intensive care unit ( ICU ) patients who underwent surgery by abdominal sepsis . This was a prospect i ve , r and omized , double-blind , controlled study set in the medical/surgical ICUs of seven teaching hospitals . Patients with severe sepsis and septic shock of intra-abdominal origin admitted to the ICU within 24 h after the onset of symptoms were included in the study . Polyvalent IgM-enriched Ig ( Pentaglobin ® ; IVIG group ) at a dosage of 7 mL/kg/day for 5 days or an equal amount of 5 % human albumin ( control group ) was r and omized . Fifty-six patients were enrolled . The overall mortality rate was 37.5.% . Twenty patients had shock and 36 had severe sepsis ( the mortality rate was 55.0 % and 25.0 % , respectively ) . In the intent-to-treat analysis , the mortality rate was reduced from 48.1 % in patients treated with antibiotic ( ATB ) plus albumin to 27.5 % ( P = 0.06 ) for patients with ATB plus IVIG . The organ failure score ( 1.0 ± 0.6 vs. 1.2 ± 0.9 ) , organ dysfunction score ( 1.7 ± 1.1 vs. 1.8 ± 1.0 ) , and reoperation rate ( 17.2 % vs. 29.6 % ) were not different between IVIG and control groups , respectively . Eight patients ( 14.3 % ) received inappropriate ATB initial therapy ( IAT ) , and seven died ( 87.5 % ) . IAT was the only variable independently associated with death ( odds ratio , 19.4 ) in a logistic regression model . We conclude that IVIG administration , when used in combination with adequate antibiotics , improved the survival of surgical ICU patients with intra-abdominal sepsis . The initial choice of antibiotic has a dramatic impact on outcome Introduction Severe sepsis is associated with high levels of morbidity and mortality , placing a high burden on healthcare re sources . We aim ed to study outcomes in the five years after severe sepsis . Methods This was a cohort study using data from a prospect i ve audit in 26 adult ICUs in Scotl and . Mortality was measured using clinical data bases and quality of life using Short Form 36 ( SF-36 ) at 3.5 and 5 years after severe sepsis . Results A total of 439 patients were recruited with a 58 % mortality at 3.5 years and 61 % mortality at 5 years . A total of 85 and 67 patients responded at 3.5 and 5 years follow-up , respectively . SF-36 physical component score ( PCS ) was low compared to population controls at 3.5 years ( mean 41.8 ( SD 11.8 ) ) and at 5 years ( mean 44.8 ( SD 12.7 ) ) . SF-36 mental component score ( MCS ) was slightly lower than population controls at 3.5 years ( mean 47.7 ( SD 14.6 ) ) and at 5 years after severe sepsis ( mean 48.8 ( SD 12.6 ) ) . The majority of patients were satisfied with their current quality of life ( QOL ) ( 80 % ) and all patients would be willing to be treated in an ICU again if they become critically ill despite many having unpleasant memories ( 19 % ) and recall ( 29 % ) of ICU events . Conclusions Patients with severe sepsis have a high ongoing mortality after severe sepsis . They also have a significantly lower physical QOL compared to population norms but mental QOL scores were only slightly below population norms up to five years after severe sepsis . All survivors would be willing to be treated in an ICU again if critically ill . Mortality and QOL outcomes were broadly similar to other critically ill cohorts throughout the five years of follow-up Whilst significant advances have been made in persuading clinical research ers of the value of conducting economic evaluation alongside clinical trials , a number of problems remain . The most fundamental is the fact that economic principles are almost entirely ignored in the traditional approach to trial design . For example , in the selection of an optimal sample size no consideration is given to the marginal costs or benefits of sample information . In the traditional approach this can lead to either unbounded or arbitrary sample sizes . This paper presents a decision-analytic approach to trial design which takes explicit account of the costs of sampling , the benefits of sample information and the decision rules of cost-effectiveness analysis . It also provides a consistent framework for setting priorities in research funding and establishes a set of screens ( or hurdles ) to evaluate the potential cost-effectiveness of research proposals . The framework permits research priority setting based explicitly on the budget constraint faced by clinical practitioners and on the information available prior to prospect i ve research . It demonstrates the link between the value of clinical research and the budgetary restrictions on service provision , and it provides practical tools to establish the optimal allocation of re sources between areas of clinical research or between service provision and research The therapeutic use of iv immunoglobulins of the G class in association with antibiotics in patients with severe sepsis is reported . As compared to the r and omized control group of patients treated with antibiotics alone , patient survival was only slightly improved ( from 25 % to 42 % ; NS ) ; however , the defervescence time was significantly shorter ( 10 vs. 16 days ) , and a greater percentage of microbiologically positive cultures became negative ( 40 % vs. 8 % ; p less than .01 ) . The percentage of \n Output:\n " }, { "from": "agent", "value": "Results We found a large degree of statistical heterogeneity in the clinical evidence on treatment effect , and the source of such heterogeneity was unclear .\nThe incremental cost-effectiveness ratio of IVIG is within the borderline region of estimates considered to represent value for money , but results appear highly sensitive to the choice of model used for clinical effectiveness .\nConclusions Our analyses suggest that there is a need for a further RCT .\nResults on the value of conducting such research , however , were sensitive to the clinical effectiveness model used , reflecting the high level of heterogeneity in the evidence base" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background — Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results , unnecessary downstream procedures , and increased cost . We judged it unlikely that patient preferences were driving the decision to obtain stress testing . Methods and Results — The Chest Pain Choice trial was a prospect i ve r and omized evaluation involving 204 patients who were r and omized to a decision aid or usual care and were followed for 30 days . The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options ( observation unit admission and stress testing or 24–72 hours outpatient follow-up ) . The primary outcome was patient knowledge measured by an immediate postvisit survey . Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing . Compared with usual care patients ( n=103 ) , decision aid patients ( n=101 ) had significantly greater knowledge ( 3.6 versus 3.0 questions correct ; mean difference , 0.67 ; 95 % CI , 0.34–1.0 ) , were more engaged in decision making as indicated by higher OPTION ( observing patient involvement ) scores ( 26.6 versus 7.0 ; mean difference , 19.6 ; 95 % CI , 1.6–21.6 ) , and decided less frequently to be admitted to the observation unit for stress testing ( 58 % versus 77 % ; absolute difference , 19 % ; 95 % CI , 6%–31 % ) . There were no major adverse cardiac events after discharge in either group . Conclusions — Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01077037 Background While some research has examined general attitudes about efforts to reduce overutilization of services , such as the Choosing Wisely ® ( CW ) initiative , little data exists regarding primary care providers ’ attitudes regarding individual recommendations . Objective We sought to identify whether particular CW recommendations were perceived by primary care providers as difficult to follow , difficult for patients to accept , or both . Design Two national surveys , one by mail to a r and om sample of 2000 U.S. primary care physicians in November 2013 , and the second electronically to a r and om sample of 2500 VA primary care providers ( PCPs ) in October – December 2014 . Participants A total of 603 U.S. primary care physicians and 1173 VA primary care providers . Response rates were 34 and 48 % , respectively . Main Measures PCP ratings of whether 12 CW recommendations for screening , testing and treatments applicable to adult primary care were difficult to follow and difficult for patients to accept ; and ratings of potential barriers to reducing overutilization . Key Results For four recommendations regarding not screening or testing in asymptomatic patients , less than 20 % of PCPs found the CW recommendations difficult to accept ( range 7.2–16.6 % ) or difficult for patients to follow ( 12.2–19.3 % ) . For five recommendations regarding testing or treatment for symptomatic conditions , however , there was both variation in reported difficulty to follow ( 9.8–32 % ) and a high level of reported difficulty for patients to accept ( 35.7–87.1 % ) . The most frequently reported barriers to reducing overuse included mal practice concern , patient requests for services , lack of time for shared decision making , and the number of tests recommended by specialists . Conclusions While PCPs found many CW recommendations easy to follow , they felt that some , especially those for symptomatic conditions , would be difficult for patients to accept . Overcoming PCPs ’ perceptions of patient acceptability will require approaches beyond routine physician education , feedback and financial incentives Objective To establish whether an interactive booklet on respiratory tract infections in children reduces reconsultation for the same illness episode , reduces antibiotic use , and affects future consulting intentions , while maintaining parental satisfaction with care . Design Pragmatic cluster r and omised controlled trial . Setting 61 general practice s in Wales and Engl and . Participants 558 children ( 6 months to 14 years ) presenting to primary care with an acute respiratory tract infection ( 7 days or less ) . Children with suspected pneumonia , asthma or a serious concomitant illness , or needing immediate hospital admission were excluded . Three withdrew and 27 were lost to follow-up , leaving 528 ( 94.6 % ) with main outcome data . Interventions Clinicians in the intervention group were trained in the use of an interactive booklet on respiratory tract infections and asked to use the booklet during consultations with recruited patients ( and provide it as a take home re source ) . Clinicians in the control group conducted their consultations as usual . Main outcome measures The proportion of children who attended a face-to-face consultation about the same illness during the two week follow-up period . Secondary outcomes included antibiotic prescribing , antibiotic consumption , future consulting intentions , and parental satisfaction , reassurance , and enablement . Results Reconsultation occurred in 12.9 % of children in the intervention group and 16.2 % in the control group ( absolute risk reduction 3.3 % , 95 % confidence interval −2.7 % to 9.3 % , P=0.29 ) . Using multilevel modelling ( at the practice and individual level ) to account for clustering , no significant difference in reconsulting was noted ( odds ratio 0.75 ; 0.41 to 1.38 ) . Antibiotics were prescribed at the index consultation to 19.5 % of children in the intervention group and 40.8 % of children in the control group ( absolute risk reduction 21.3 % , 95 % confidence interval 13.7 to 28.9 ) , P<0.001 ) . A significant difference was still present after adjusting for clustering ( odds ratio 0.29 ; 0.14 to 0.60 ) . There was also a significant difference in the proportion of parents who said they would consult in the future if their child developed a similar illness ( odds ratio 0.34 ; 0.20 to 0.57 ) . Satisfaction , reassurance , and parental enablement scores were not significantly different between the two groups . Conclusions Use of a booklet on respiratory tract infections in children within primary care consultations led to important reductions in antibiotic prescribing and reduced intention to consult without reducing satisfaction with care . Trial registration Current Controlled Trials IS RCT Background : Few interventions have proven effective in reducing the overuse of antibiotics for acute respiratory infections . We evaluated the effect of DECISION+2 , a shared decision-making training program , on the percentage of patients who decided to take antibiotics after consultation with a physician or resident . Methods : We performed a r and omized trial , clustered at the level of family practice teaching unit , with 2 study arms : DECISION+2 and control . The DECISION+2 training program included a 2-hour online tutorial followed by a 2-hour interactive seminar about shared decision-making . The primary outcome was the proportion of patients who decided to use antibiotics immediately after consultation . We also recorded patients ’ perception that shared decision-making had occurred . Two weeks after the initial consultation , we assessed patients ’ adherence to the decision , repeat consultation , decisional regret and quality of life . Results : We compared outcomes among 181 patients who consulted 77 physicians in 5 family practice teaching units in the DECISION+2 group , and 178 patients who consulted 72 physicians in 4 family practice teaching units in the control group . The percentage of patients who decided to use antibiotics after consultation was 52.2 % in the control group and 27.2 % in the DECISION+2 group ( absolute difference 25.0 % , adjusted relative risk 0.48 , 95 % confidence interval 0.34–0.68 ) . DECISION+2 was associated with patients taking a more active role in decision-making ( Z = 3.9 , p < 0.001 ) . Patient outcomes 2 weeks after consultation were similar in both groups . Interpretation : The shared decision-making program DECISION+2 enhanced patient participation in decision-making and led to fewer patients deciding to use antibiotics for acute respiratory infections . This reduction did not have a negative effect on patient outcomes 2 weeks after consultation . Clinical Trials.gov trial register no. NCT01116076 Objective To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome . Design Multicenter pragmatic parallel r and omized controlled trial . Setting Six emergency departments in the United States . Participants 898 adults ( aged > 17 years ) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing ( 451 were allocated to the decision aid and 447 to usual care ) , and 361 emergency clinicians ( emergency physicians , nurse practitioners , and physician assistants ) caring for patients with chest pain . Interventions Patients were r and omly assigned ( 1:1 ) by an electronic , web based system to shared decision making facilitated by a decision aid or to usual care . The primary outcome , selected by patient and caregiver advisers , was patient knowledge of their risk for acute coronary syndrome and options for care ; secondary outcomes were involvement in the decision to be admitted , proportion of patients admitted for cardiac testing , and the 30 day rate of major adverse cardiac events . Results Compared with the usual care arm , patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care ( questions correct : decision aid , 4.2 v usual care , 3.6 ; mean difference 0.66 , 95 % confidence interval 0.46 to 0.86 ) , were more involved in the decision ( observing patient involvement scores : decision aid , 18.3 v usual care , 7.9 ; 10.3 , 9.1 to 11.5 ) , and less frequently decided with their clinician to be admitted for cardiac testing ( decision aid , 37 % v usual care , 52 % ; absolute difference 15 % ; P<0.001 ) . There were no major adverse cardiac events due to the intervention . Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk , increased engagement , and safely decreased the rate of admission to an observation unit for cardiac testing . Trial registration Clinical Trials.gov NCT01969240 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more INTRODUCTION Antibiotic overuse promotes resistant strains of bacteria and puts patients at risk for adverse reactions . Given the use of educational posters in government-sponsored public health campaigns , this study examined the effectiveness of a waiting room poster in reducing excessive antibiotic use in clinical practice . METHODS Investigators conducted a 1-month trial of an educational poster with historical controls using three private pediatric group practice s in Westchester County , New York . Children between the ages of 6 months and 10 years at the time of a visit to diagnose and treat symptoms of respiratory illness were enrolled as subjects . Antibiotic prescriptions for children with respiratory illnesses seen during the poster month were compared with prescriptions written during three 1-month historical control periods . The proportion of visits that result ed in a prescription for an antibiotic served as the outcome measure . RESULTS Overall , 326 of the 720 patients ( 45.2 % ) enrolled in the study were treated with an antibiotic . Multiple logistic regression analysis revealed no statistically significant difference in the proportion of visits result ing in an antibiotic prescription among the 4 study months ( P = .79 ) , indicating that the educational poster had no effect on antibiotic use . DISCUSSION Public education in the form of a waiting room poster was not sufficient to decrease antibiotic prescriptions . This finding has implication s for current large-scale programs and for health care providers as they continue to attempt to educate patients on the appropriate use of antibiotics Decision aids are evidence -based sources of health information that can help patients make informed treatment decisions . However , little is known about how decision aids affect health care use when they are implemented outside of r and omized controlled clinical trials . We conducted an observational study to examine the associations between introducing decision aids for hip and knee osteoarthritis and rates of joint replacement surgery and costs in a large health system in Washington State . Consistent with prior r and omized trials , our introduction of decision aids was associated with 26 percent fewer hip replacement surgeries , 38 percent fewer knee replacements , and 12 - 21 percent lower costs over six months . These findings support the concept that patient decision aids for some health conditions , for which treatment decisions are highly sensitive to both patients ' and physicians ' preferences , may reduce rates of elective surgery and lower costs OBJECTIVES To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section . DESIGN R and omised trial , conducted from May 2004 to August 2006 . SETTING Four maternity units in south west Engl and , and Scotl and . PARTICIPANTS 742 pregnant women with one previous lower segment caesarean section and delivery expected at > or=37 weeks . Non-English speakers were excluded . INTERVENTIONS Usual care : st and ard care given by obstetric and midwifery staff . Information programme : women navigated through descriptions and probabilities of clin \n Output:\n " }, { "from": "agent", "value": "De-implementation interventions that engage patients within the patient-clinician interaction through patient-targeted educational material s or shared decision-making tools are effective in decreasing the use of low-value care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate an intervention to improve food label knowledge and skills in diabetes management among older adults with diabetes mellitus . DESIGN A r and omized pretest-posttest control group design was used . SUBJECTS/ SETTING Participants ( 48 experimental , 50 control ) were aged 65 years and older with type 2 diabetes for 1 year or longer ; 93 participants ( 95 % ) completed the study , conducted in an outpatient setting . INTERVENTION The intervention included 10 weekly group sessions led by a dietitian . Information processing , learning theory , and Social Cognitive Theory principles were used in program development and evaluation . MAIN OUTCOME MEASURES Participants ' knowledge , outcome expectations ( expected results of behavior ) , self-efficacy , and decision-making skills were assessed . Instrument validity and reliability were established before program evaluation . STATISTICAL ANALYSES PERFORMED Factor analysis identified underlying factor structures . Analysis of covariance with pretest score as covariate was used to compare groups at posttest . Paired t tests compared results within groups . RESULTS Two factors were identified for outcome expectations ( positive and negative ) and for self-efficacy ( promoters of and barriers to diabetes management ) . The experimental group had greater improvement in total knowledge scores ( mean + /- st and ard error of the mean : 7.8+/-0.7 ) than the control group ( 0.2+/-0.7 ) ( P < .0001 ) , positive outcome expectations ( 0.59+/-0.15 vs 0.06+/-0.15 , P = .01 ) , promoters of diabetes management ( 0.83+/-0.12 vs -0.09+/-0.18 , P < or = .001 ) and decision-making skills ( 5.1+/-0.5 vs 0.3+/-0.5 , P < .0001 ) and greater reduction in barriers to diabetes management ( 1.1+/-0.16 vs 0.34+/-0.16 , P < .01 ) . No significant difference in negative outcome expectations occurred between groups at posttest . APPLICATIONS/ CONCLUSIONS Older adults with diabetes can benefit from nutrition education design ed to improve knowledge and skills necessary for diabetes management Purpose . Examine the effects of three iterative tailored feedback letters addressing smoking ; physical activity ; and fruit , vegetable , and fat intake , and test the additional effects of providing feedback on action plans . Design . A tailored , print-based intervention was developed and tested in a r and omized control trial with a posttest after 9 months . Setting . A total of 2827 respondents agreed to participate . They were recruited from a r and om sample of 35,000 addresses obtained through the Dutch national telephone company . Subjects . The mean age was 49 years , and 55 % were female . Intervention . The experimental group received three printed tailored letters , and the control group received three printed generic letters . Respondents from the experimental group r and omly received either a third letter with tailored information or tailored information and action-planning feedback . Measures . The question naire assessed physical activity ; smoking ; consumption of fruit , vegetables and fat ; motivational determinants ; action plans ; and demographics . Results . Tailored information result ed in more improvement over time than generic information for the intake of fruit , vegetables , and fat and for physical activity . No differences between the conditions were found for smoking because of high cessation rates in all conditions . Action-planning feedback did not increase the effects . Conclusions . Tailored lifestyle information can be effective for adults in changing nutrition behavior and physical activity Background Although experts cl aim that computer-tailored interventions provided over the Internet have great potential to promote health behavior change , few studies have tested the efficacy of computer-tailored lifestyle interventions online-delivered over the Internet . Purpose To evaluate the short-term ( 1 month ) efficacy of an Internet-delivered , computer-tailored lifestyle intervention targeting saturated fat intake , physical activity ( PA ) , and smoking cessation , and to evaluate exposure to the intervention . Methods A pretest – posttest r and omized controlled trial with an intervention group and a no intervention waiting list control group was conducted . Self-reported behavior and determinants were assessed at baseline and 1 month follow-up . Exposure to the intervention was monitored through server registration s. The data were analyzed using multiple linear and logistic regression analysis . Results The intervention result ed in a significantly lower self-reported saturated fat intake ( b = −0.76 , p < 0.01 ) and a higher likelihood of meeting the PA guidelines among respondents who were insufficiently active at baseline ( OR = 1.34 , 95%CI = 1.001–1.80 ) . No significant intervention effects were found for self-reported smoking status . Of the participants , 81 % actually visited the website . Conclusions The Internet-delivered , computer-tailored lifestyle intervention was effective in reducing self-reported saturated fat intake and in increasing self-reported PA among participants who completed the study Purpose The purpose of this study was to evaluate the community-based Chronic Disease Self-management Program ( CDSMP ) and the Spanish- language version ( Tom and o Control de Su Salud ) programs as delivered in setting s along the Texas/New Mexico/Mexico border . The programs had proven effective in r and omized trials , and the authors wished to determine if they would be as effective when administered by others to different population s. Methods The El Paso Diabetes Association administered the CDSMP and Tom and o to 445 persons with chronic illness ( two thirds with diabetes ) in Texas , New Mexico , and Mexico . Four-month and 1-year outcomes were compared to baseline using t tests of change scores . Regression models were used to test whether baseline demographics and self-efficacy were associated with positive outcomes of the programs . Results Participants showed improvements in health behaviors , health status , and self-efficacy at both 4 month and 1 year . Baseline self-efficacy and 4-month change in self-efficacy were significantly associated with improved 1- year outcomes . Conclusions The CDSMP and Tom and o are effective when used in setting s other than that of the original study for population s other than those for which they were initially developed This study compared the efficacy of two low-cost interventions for physical activity adoption . Sedentary ( N=194 ) adults recruited through newspaper advertisements were r and omized to receive either a motivationally-matched , individually-tailored intervention ( IT ) or a st and ard self-help intervention ( ST ) . Assessment s and interventions were delivered by repeated mailings at baseline , one , three , and six months . Participants were assessed regarding current physical activity behavior , motivational readiness to adopt regular physical activity , and psychological constructs associated with physical activity participation ( e.g. self-efficacy , decisional balance ) . Repeated measures analyses of variance ( ANOVAs ) revealed significant increases in physical activity participation between baseline and six months for both groups with a significantly greater increase among IT participants . The IT group outperformed the ST group on all primary outcome measures : ( a ) minutes of physical activity per week , ( b ) reaching Centers for Disease Control and American College of Sports Medicine ( CDC/ACSM ) recommended minimum physical activity criteria , and ( c ) achieving the Action stage of motivational readiness for physical activity adoption . Both groups showed significant improvement between baseline and six months on the psychological constructs associated with physical activity adoption ( e.g. self-efficacy ) , with no significant differences observed between the treatment groups . Utilizing computer expert systems and self-help manuals to provide individually-tailored , motivationally-matched interventions appears to be an effective , low-cost approach for enhancing physical activity participation in the community BACKGROUND Rates of physical inactivity and poor nutrition , which are 2 of the most important modifiable risk factors for cardiovascular disease in women , are substantial . Even so , studies of interventions design ed to improve lifestyle behaviors in women have been limited and often confined to particular geographical areas . OBJECTIVE To evaluate the effect of Choose to Move on increasing women 's physical activity , improving their knowledge of heart disease and stroke , and improving their nutrition . PARTICIPANTS AND METHODS A prospect i ve , nonr and omized , 12-week educational intervention design ed by the American Heart Association for women across the United States . Participants received a welcome kit and manual with weekly information about how to manage cardiovascular disease risk factors and how to build a support system for lifestyle change . Women ( N = 23 171 ) aged 25 years or older were recruited by direct mail , the media , health care providers , and other means . Follow-up evaluations were returned from 6389 women at 2 weeks , 5338 at 4 weeks , 4209 at 8 weeks , 3916 at 10 weeks , and 3775 at 12 weeks . Participants self-reported their physical activity , diet , and knowledge about heart disease , stroke , and related symptoms . RESULTS Ninety percent of the participants were white and 56 % were aged between 35 and 54 years . Among the participants who completed the week 12 follow-up evaluation , the percentage who reported being active ( at least moderate exercise > or = 5 times per week or > 2(1/2 ) hours per week for the past 1 to 6 months ) increased from 32 % at baseline to 67 % at the program 's end ( P = .001 ) . Participants currently limiting excess calories or fat increased from 72 % to 91 % at week 10 follow-up evaluation ( P = .001 ) . The proportion correctly identifying heart disease as the leading cause of death increased from 84 % to 91 % at week 10 follow-up evaluation ( P<.001 ) . CONCLUSIONS Women who completed the Choose to Move program evaluation reported that they significantly increased their levels of physical activity , reduced their consumption of high-fat foods , and increased their knowledge and awareness of cardiovascular disease risk and its symptoms . This program provides an important model for public health , voluntary , and other health organizations of population -based , targeted low-cost self-help programs that support the Healthy People 2010 objectives for physical activity , nutrition , and cardiovascular health Chronic obstructive pulmonary disease ( COPD ) is disabling , with symptoms such as chronic cough , phlegm , wheezing , shortness of breath and increased infections of the respiratory passage . The aim was to examine the effects of a structured educational intervention programme at a nurse-led primary health care clinic ( PHCC ) on quality of life ( QoL ) , knowledge about COPD and smoking cessation in patients with COPD . This study had an experimental design in which 52 patients with COPD from a Swedish primary care setting were r and omized into two groups ( intervention or control ) . Both groups received st and ard care but patients in the intervention group were also offered two visits to a nurse specialized in COPD care . The purpose of the visits was to increase the patients ' self-care ability and their knowledge about COPD . The study was approved by the local Research Ethics Committee . Data were collected using two question naires , one pertaining to knowledge about COPD and smoking habits and St. George 's Respiratory Question naire , addressing how QoL was affected by the patients ' respiratory symptoms . The intervention and control groups answered both question naires on their first and last visits to the PHCC . A statistically significant increase was noted in the intervention group on QoL , the number of patients who stopped smoking and patients ' knowledge about COPD at the follow-up , 3 - 5 months after intervention . However , a confounding factor may have been that one of the research ers ( Eva Osterlund Efr aims son ) , as a nurse in the PHCC , performed the intervention . This implies that patients were in a dependent relationship which may have affected the responses in a favourable direction . Our findings show that conventional care alone did not have an effect on patients ' QoL and smoking habits . Instead , the evidence suggests that a structured programme with self-care education is needed to motivate patients for life-style changes BACKGROUND We evaluated a multifaceted preventive nutrition intervention to improve dietary habits among adult primary care patients . METHODS We r and omized six group practice s in a managed care organization . Participants completed baseline and 3-month follow-up surveys . The intervention comprised ( 1 ) mailed personalized dietary recommendations and educational booklets focusing on fruits and vegetables , red meat , and dairy foods , tailored to patients ' baseline intake and stage of readiness to change eating behaviors ; ( 2 ) verbal endorsement by the primary care provider of the benefits of these recommendations ; and ( 3 ) two motivational counseling sessions with telephone counselors to set dietary goals . RESULTS Among the 230 subjects in the intervention group and 274 in the control group , mean age was 54 years , 70 % were female , and 91 % were white and 7 % African American . Eighty-nine percent of the participants completed the follow-up survey . We measured change in intake of foods using results from the baseline and follow-up food frequency question naires . Using an intention-to-treat analysis and adjusting for age , sex , race , and baseline intake , the change in fruit and vegetable intake in the intervention group was 0.6 ( 95 % confidence interval 0.3 , 0.8 ) servings/day higher than in the control group . There was no intervention effect on red meat and dairy products . CONCLUSIONS Tailored clinical nutrition interventions that combine brief physician endorsement with practice supports may be effective in changing patients ' eating behavior BACKGROUND Increasing regular physical activity in adults at elevated risk of cardiovascular disease is an important target for preventive medicine . This study evaluated demographic , social and cognitive predictors of self-reported changes in physical activity after 4 and 12 months in a r and omized trial of behavioral counseling in primary \n Output:\n " }, { "from": "agent", "value": "More interventions in primary health care than the community were effective in supporting smoking cessation whereas the reverse was true for diet and physical activity interventions .\nConclusion Group and individual interventions of varying intensity in primary health care and community setting s are useful in supporting sustained change in health literacy for change in behavioral risk factors .\nCertain aspects of risk behavior may be better h and led in clinical setting s while others more effectively in the community ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 . METHOD A r and omized , controlled trial comparing MBCT+TAU ( n=102 ) with TAU alone ( n=103 ) . The study population consisted of patients with three or more previous depressive episodes . Primary outcome measure was post-treatment depressive symptoms according to the Hamilton Rating Scale for Depression . Secondary outcome measures included the Beck Depression Inventory , rumination , worry and mindfulness skills . Group comparisons were carried out with linear mixed modelling , controlling for intra-group correlations . Additional mediation analyses were performed . 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 . MBCT result ed in a comparable reduction of depressive symptoms for patients with and without a current depressive episode . 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 . Directions towards a better underst and ing of the mechanisms of action of MBCT are given , although future research is needed to support these hypotheses Objectives : converging research suggests that mindfulness training exerts its therapeutic effects on depression by reducing rumination . Theoretically , rumination is a multifaceted construct that aggregates multiple neurocognitive aspects of depression , including poor executive control , negative and overgeneral memory bias , and persistence or stickiness of negative mind states . Current measures of rumination , most-often self-reports , do not capture these different aspects of ruminative tendencies , and therefore are limited in providing detailed information about the mechanisms of mindfulness . Methods : we developed new insight into the potential mechanisms of rumination , based on three model-based metrics of free recall dynamics . These three measures reflect the patterns of memory retrieval of valenced information : the probability of first recall ( Pstart ) which represents initial affective bias , the probability of staying with the same valence category rather than switching , which indicates strength of positive or negative association networks ( Pstay ) , and probability of stopping ( Pstop ) or ending recall within a given valence , which indicates persistence or stickiness of a mind state . We investigated the effects of Mindfulness-Based Cognitive Therapy ( MBCT ; N = 29 ) vs. wait-list control ( N = 23 ) on these recall dynamics in a r and omized controlled trial in individuals with recurrent depression . Participants completed a st and ard laboratory stressor , the Trier Social Stress Test , to induce negative mood and activate ruminative tendencies . Following that , participants completed a free recall task consisting of three word lists . This assessment was conducted both before and after treatment or wait-list . Results : while MBCT participant ’s Pstart remained relatively stable , controls showed multiple indications of depression-related deterioration toward more negative and less positive bias . Following the intervention , MBCT participants decreased in their tendency to sustain trains of negative words and increased their tendency to sustain trains of positive words . Conversely , controls showed the opposite tendency : controls stayed in trains of negative words for longer , and stayed in trains of positive words for less time relative to pre-intervention scores . MBCT participants tended to stop recall less often with negative words , which indicates less persistence or stickiness of negatively valenced mental context . Conclusion : MBCT participants showed a decrease in patterns that may perpetuate rumination on all three types of recall dynamics ( Pstart , Pstay , and Pstop ) , compared to controls . MBCT may weaken the strength of self-perpetuating negative associations networks that are responsible for the persistent and “ sticky ” negative mind states observed in depression , and increase the positive associations that are lacking in depression . This study also offers a novel , objective method of measuring several indices of ruminative tendencies indicative of the underlying mechanisms of rumination OBJECTIVE To examine whether mindfulness-based cognitive therapy ( MBCT ) increases momentary positive emotions and the ability to make use of natural rewards in daily life . METHOD Adults with a life-time history of depression and current residual depressive symptoms ( mean age = 43.9 years , SD = 9.6 ; 75 % female ; all Caucasian ) were r and omized to MBCT ( n = 64 ) or waitlist control ( CONTROL ; n = 66 ) in a parallel , open-label , r and omized controlled trial . The Experience Sampling Method was used to measure momentary positive emotions as well as appraisal of pleasant activities in daily life during 6 days before and after the intervention . Residual depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale ( Hamilton , 1960 ) . RESULTS MBCT compared to CONTROL was associated with significant increases in appraisal s of positive emotion ( b * = .39 ) and activity pleasantness ( b * = .22 ) as well as enhanced ability to boost momentary positive emotions by engaging in pleasant activities ( b * = .08 ; all ps < .005 ) . Associations remained significant when corrected for reductions in depressive symptoms or for reductions in negative emotion , rumination , and worry . In the MBCT condition , increases in positive emotion variables were associated with reduction of residual depressive symptoms ( all ps < .05 ) . CONCLUSIONS MBCT is associated with increased experience of momentary positive emotions as well as greater appreciation of , and enhanced responsiveness to , pleasant daily-life activities . These changes were unlikely to be pure epiphenomena of decreased depression and , given the role of positive emotions in resilience against depression , may contribute to the protective effects of MBCT against depressive relapse Research suggests that suppressing unwanted thoughts is not possible , leads to a subsequent increase in frequency of the suppressed thoughts , and results in higher levels of distress . Because thought suppression may have negative effects , an alternative , acceptance-based approach has been proposed . The current paper reports the outcomes of two studies . Study I examined the relationships between two naturally occurring strategies of thought management ( thought suppression and acceptance ) , symptoms of psychopathology , and experiences with personally relevant intrusive thoughts . Results showed that those who naturally suppress personally relevant intrusive thoughts have more , are more distressed by , and have a greater \" urge to do something \" about the thoughts , while those who are naturally more accepting of their intrusive thoughts are less obsessional , have lower levels of depression , and are less anxious . Study II compared three groups ( thought suppression , acceptance , and monitor-only groups ) on the frequency and distress associated with experiencing personally relevant intrusive thoughts . Results revealed that those instructed to suppress their personal intrusive thoughts were unable to do so and experienced an increased level of distress after suppression , whereas those instructed to use an acceptance-based strategy experienced a decrease in discomfort level ( but not thought frequency ) after having used such a strategy . These data offer initial evidence that acceptance may be a useful alternative to the suppression of personally relevant intrusive thoughts Major Depressive Disorder ( MDD ) manifests in 20 - 30 % of college students , with increased incidence in recent decades . Very limited research has assessed the efficacy of evidence -based interventions for MDD in college students . Mindfulness-Based Therapy ( MBT ) and Behavioral Activation ( BA ) are two interventions with significant potential to meet dem and s of college counseling clinics and effectively treat college students with MDD . This study utilized a r and omized controlled research design ( n = 50 ) to examine the efficacy of four-sessions of abbreviated MBT and BA relative to a wait-list control condition with depressed college students . Intent-to-treat data analyses on depression outcome measures suggested both treatments were superior to the control group . There were significant pre-post treatment improvements across measures of depression , rumination , stress , and mindfulness , gains largely maintained at 1-month follow-up . Neither active treatment effectively reduced somatic anxiety . Both treatments generally had moderate-strong effect sizes relative to the control group , and based on depression response and remission criteria , 56 - 79 % of patients exhibited clinical ly significant improvement . Based on reliable change indices , 75 - 85 % experienced clinical ly significant reductions in depression . There was strong therapist competence and adherence to treatment protocol s and high patient satisfaction with both interventions . Study limitations and implication s for the assessment and treatment of depressed college students are discussed OBJECTIVES The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women . DESIGN Prospect i ve , r and omized , controlled 12 week intervention pilot study . Depressive symptoms were assessed at baseline , post-intervention ( 12 weeks ) , and one-month follow-up . SETTING Women with a history of diagnosed depression and currently depressed were r and omized to a mindfulness-based yoga condition or a walking control . INTERVENTIONS The mindfulness-based yoga intervention consisted of a home-based yoga asana , pranayama and meditation practice with mindfulness education sessions delivered over the telephone . The walking control condition consisted of home-based walking sessions and health education sessions delivered over the phone . MAIN OUTCOME MEASURES The Beck Depression Inventory ( BDI ) and Ruminative Responses Scale ( RRS ) . RESULTS Both groups reported decreases in depressive symptoms from baseline to post-intervention , f(1,33)=34.83 , p<0.001 , and from baseline to one-month follow-up , f(1,33)=37.01 , p<0.001 . After controlling for baseline , there were no significant between group differences on depression scores at post-intervention and the one-month follow-up assessment . The mindfulness-based yoga condition reported significantly lower levels of rumination than the control condition at post-intervention , after controlling for baseline levels of rumination , f(1,31)=6.23 , p<0.01 . CONCLUSIONS These findings suggest that mindfulness-based yoga may provide tools to manage ruminative thoughts among women with elevated depressive symptoms . Future studies , with larger sample s are needed to address the effect of yoga on depression and further explore the impact on rumination OBJECTIVES Mindfulness-based cognitive therapy ( MBCT ) is a new group-based intervention for prevention of relapse in recurrent depression which has not been scientifically evaluated regarding its clinical effectiveness for ameliorating residual depressive symptoms following a depressive episode . The aim of this study was to assess the efficacy of MBCT in reducing residual depressive symptoms in psychiatric out patients with recurrent depression , and to particularly explore the effects of mindfulness techniques on rumination . DESIGN The design of this study was a mixed model complex design . Design 1 consisted of a consecutive series of patients . They were assigned to either MBCT or TAU . The independent variables were time and group allocation , and dependent variables were Beck Depression Inventory ( BDI ) and Rumination Scale . In Design 2 , the TAU group proceeded to complete an MBCT group , and the BDI and Rumination Scale results of the two groups were collapsed . METHOD Nineteen patients with residual depressive symptoms following a depressive episode , and who were attending outpatient clinic , were assigned to either MBCT or treatment as usual ( TAU ) , with the TAU group then proceeding to complete an MBCT group . Depressive and ruminative symptoms were assessed before , during , and after treatment , and at one-month follow-up . RESULTS A significant reduction in depressive symptoms was found at the end of MBCT , with a further reduction at one-month follow-up . A trend towards a reduction in rumination scores was also observed . CONCLUSIONS Group MBCT has a marked effect on residual depressive symptoms , which may be mediated through the mindfulness-based cognitive approach towards excessive negative ruminations in patients with residual depressive symptoms following a depressive episode OBJECTIVE To examine whether metacognitive psychological skills , acquired in mindfulness-based cognitive therapy ( MBCT ) , are also present in patients receiving medication treatments for prevention of depressive relapse and whether these skills mediate MBCT 's effectiveness . METHOD This study , embedded within a r and omized efficacy trial of MBCT , was the first to examine changes in mindfulness and decentering during 6 - 8 months of antidepressant treatment and then during an 18-month maintenance phase in which patients discontinued medication and received MBCT , continued on antidepressants , or were switched to a placebo . In total , 84 patients ( mean age = 44 years , 58 % female ) were r and omized to 1 of these 3 prevention conditions . In addition to symptom variables , changes in mindfulness , rumination , and decentering were assessed during the phases of the study . RESULTS Pharmacological treatment of acute depression was associated with reductions in scores for rumination and increased wider experiences . During the maintenance phase , only patients receiving MBCT showed significant increases in the ability to monitor and observe thoughts and feelings as measured by the Wider Experiences ( p < .01 ) and Decentering ( p < .01 ) subscales of the Experiences Question naire and by the Toronto Mindfulness Scale . In addition , changes in Wider Experiences ( p < .05 ) and Curiosity ( p < .01 ) predicted lower Hamilton Rating Scale for Depression scores at 6-month follow-up . CONCLUSIONS An increased capacity for decentering and curiosity may be fostered during MBCT and may underlie its effectiveness . With practice , patients can learn to counter habitual avoidance tendencies and to regulate dysphoric affect in ways that support recovery \n Output:\n " }, { "from": "agent", "value": "Furthermore , findings suggest that mindfulness/acceptance processes might mediate changes in rumination , and that they in turn mediate in the clinical effects of interventions .\nConclusions : Mindfulness-based cognitive therapy compared to usual care , produces a significant and moderate reduction in rumination ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE We prospect ively investigated the efficacy of opioid rotation from oral morphine to oral oxycodone in cancer patients who had difficulty in continuing oral morphine treatment because of inadequate analgesia and /or intolerable side effects . METHODS Twenty-seven patients were enrolled and 25 were evaluated . The rate of patients who achieved adequate pain control , which provided an indication of treatment success , was evaluated as primary endpoint . The acceptability and pharmacokinetics of oxycodone were evaluated in addition to the assessment of analgesic efficacy and safety during the study period . RESULTS In spite of intense pain , the morphine daily dose could not be increased in most patients before the study because of intolerable side effects . However , switching to oral oxycodone allowed approximately 1.7-fold increase as morphine equivalent dose . Consequently , 84.0 % ( 21/25 ) of patients achieved adequate pain control . By the end of the study , all patients except one had tolerated the morphine-induced intolerable side effects ( i.e. nausea , vomiting , constipation , drowsiness ) . Common side effects ( > 10 % ) that occurred during the study were typically known for strong opioid analgesics , and most were mild to moderate in severity . A significant negative correlation between creatinine clearance ( CCr ) value and the trough concentrations of the morphine metabolites was observed . On the other h and , no significant correlation was found between CCr value and the pharmacokinetic parameters of oxycodone or its metabolites . CONCLUSIONS For patients who had difficulty in continuing oral morphine treatment , regardless of renal function , opioid rotation to oral oxycodone may be an effective approach to alleviate intolerable side effects and pain Opioid switching is often used to improve the opioid response in cancer patients experiencing poor analgesia or adverse effects . However , no data are available on plasmatic changes of opioids and their metabolites during these phases , and whether there exists a relationship with the clinical events . In a prospect i ve study of 10 consecutive cancer patients on oral morphine but with uncontrolled pain ( greater > 4 on a numerical scale of 0 to 10 ) and /or moderate to severe opioid adverse effects ( on a level of 2 and 3 of a verbal scale ) and not responsive to adjuvant medications , switching to oral methadone was performed using a fixed ratio of 5:1 , leaving extra-doses of 1/5 of the daily dose of methadone calculated as needed . Blood sample s were obtained at the same hour for four days , before the switching , and then on day 1 , 2 , and 3 . The intensity of pain and the adverse effects were assessed daily to calculate the switching score before and after switching . Completed blood sample s were obtained in 9 patients . One patient was separately considered , because of his renal impairment . Significant improvements in pain intensity as well as adverse effects within an average period of 1–2 days were observed . Morphine , morphine-6-glucuronide , and morphine-3-glucuronide were progressively cleared from plasma to almost disappear within three days . Methadone rapidly achieved a stable concentration in 1–2 days . The doses of methadone were changed , but not significantly , and tended to decrease in the following days , according to the clinical situation . The results of this study confirm the need to stop rapidly morphine , and to use a priming dose of methadone , rather than using progressive decrements and increments of morphine and methadone , respectively , during opioid switching . This method allows for a rapid clearance of morphine and its metabolites are rapidly cleared , except in patients with renal failure . Opioid plasma changes substantially overlap the clinical changes observed in these patients , in terms of benefit between analgesia and adverse effects OBJECTIVE This prospect i ve study documents the use of methadone as part of an opioid rotation strategy in patients with uncontrolled pain and severe delirium admitted for terminal care to a tertiary cancer palliative care hospital . METHODS We review ed the treatment of 20 patients with severe pain and delirium at the end of life who 's delirium did not improve 24 h or longer after starting a neuroleptic medication . RESULTS Ten male and 10 female patients , 47 to 77 years old , were rotated or \" switched \" to methadone due to uncontrolled pain in the setting of delirium , limiting further opioid dose escalation . At 2 weeks , a total of 10 patients had expired . Of the 10 patients who were alive 2 weeks after starting methadone , 7 patients were stable on an average of 1.1 mg/h methadone , 2 patients were restarted on morphine IV and one on Percocet . The calculated average equianalgesic dose of methadone was 9 % ( 2%-17 % ) of the previous morphine-equivalent dose . Of the 20 patients who were switched to methadone for what appeared to be terminal delirium , the pain control was significant in 15 , moderate in 3 , and unchanged in 2 patients . Average analgesia was good to excellent ( average Numeric Analog Scale rating [ NAS ] decreased from 8.2 to 2.5 ) . Sedation had decreased from 1.65 to 0.55 on a scale of 0 to 3 . Of the 20 patients , improvement of cognitive status was significant in 9 , moderate in 6 , partial in 2 , and none in 3 patients . The Memorial Delirium Assessment Scale ( MDAS ) showed improvement from an average of 23.6 prior to the switch to 10.6 3 days after . Decreased alertness on methadone was devoid of agitated features . SIGNIFICANCE OF RESULTS Our study suggests that methadone can be effective in the treatment of both refractory pain and what appears to be terminal delirium . Most patients in our group had at least a short-term improvement in mental status as well as significant and lasting improvement in analgesia Background Due to tolerance development and adverse side effects , chronic pain patients frequently need to be switched to alternative opioid therapy Objective To assess the efficacy and tolerability of an alternative transdermally applied ( TDS ) opioid in patients with chronic cancer pain receiving insufficient analgesia using their present treatment . Methods A total of 32 patients received alternative opioid therapy , 16 were switched from buprenorphine to fentanyl and 16 were switched from fentanyl to buprenorphine . The dosage used was 50 % of that indicated in equipotency conversion tables . Pain relief was assessed at weekly intervals for the next 3 weeks Results Pain relief as assessed by VAS , PPI , and PRI significantly improved ( p < 0.0001 ) in all patients at all 3 follow up visits . After 3 weeks of treatment , the reduction in the mean VAS , PPI , and PRI scores in the fentanyl and buprenorphine groups was 68 , 77 , 74 , and 69 , 79 , and 62 % , respectively . Over the same time period the use of oral morphine as rescue medication was reduced from 27.5 ± 20.5 ( mean ± SD ) to 3.75 ± 8.06 , and 33.8 ± 18.9 to 3.75 ± 10.9 mg/day in the fentanyl and buprenorphine groups , respectively . There was no significant difference in either pain relief or rescue medication use between the two patient groups The number of patient with adverse events fell during the study . After the third week of the treatment the number of patients with constipation was reduced from 11 to 5 , and 10 to 4 patients in the fentanyl and buprenorphine groups , respectively . There was a similar reduction in the incidence of nausea and vomiting . No sedation was seen in any patient after one week of treatment . Conclusion Opioid switching at 50 % of the calculated equianalgesic dose produced a significant reduction in pain levels and rescue medication . The incidence of side effects decreased and no new side effects were noted . Further studies are required to provide individualized treatment for patients according to their different types of cancer The study objective was to determine whether switching patients from morphine to transdermal fentanyl result ed in a reduction of morphine-associated side effects , and an improvement in cognitive function and patients ' well being while maintaining adequate pain and symptom control . Nineteen patients aged 42– 86 with terminal cancer , maintained on morphine for pain and distressed as a result of morphine toxicity , were given the dose of fentanyl corresponding to their current morphine dose . Pain control was then maintained ( mostly fentanyl 50– 100 μg/h ) over the 14-day study period . Throughout the study , patients ' global assessment of well being ( primary efficacy variable ) was statistically significantly improved . Sleepiness and drowsiness were significantly less of a problem . There was a trend towards improvement in attention span/ concentration , and in the power and quality of concentration . Cognitive function tests also revealed a significant improvement in working ( short term ) and speed of memory although not in secondary ( long term ) memory . Patients did not experience hallucinations or delusions and there was no change in levels of anxiety or depression ( Hospital Anxiety Depression Scale ) . The incidence of dizziness was significantly reduced , and there was a nonsignificant decrease in number of patients who suffered myoclonus and in the severity of this condition over the 14 days . The investigator 's overall impression of treatment with transdermal fentanyl was ‘ fair ’ , which was not in agreement with the positive impression expressed by patients ( score 74 , range : 0 worst , 100 best ) . Further work is required to determine if the improvement in patients ' well being and cognitive function is achieved in larger study population Although recent studies suggest that opioid rotation could be an effective treatment strategy for morphine-induced delirium , there have been no prospect i ve studies to investigate the treatment effects of opioid rotation using fentanyl . The primary aim of this study was to clarify the efficacy of opioid rotation from morphine to fentanyl in symptom palliation of morphine-induced delirium . Twenty-one consecutive cancer patients with morphine-induced delirium underwent opioid rotation to fentanyl . Physicians recorded the symptom severity of delirium ( the Memorial Delirium Assessment Scale , MDAS ) , pain , and other symptoms ( categorical verbal scale from 0 : none to 3 : severe ) and the Schedule for Team Assessment Scale ( STAS ) ( from 0 : none to 4 : extreme ) ; and performance status at the time of study enrollment and three and seven days after . Of 21 patients recruited , one patient did not complete the study . In the remaining 20 patients , morphine was substituted with transdermal fentanyl in 9 patients and parenteral fentanyl in 11 patients . Total opioid dose increased from 64 mg oral morphine equivalent/day ( Day 0 ) to 98 mg/day ( Day 7 ) , and the median increase in total opioid dose was 42 % . Treatment success , defined as an MDAS score below 10 and pain score of 2 or less , was obtained in 13 patients on Day 3 and 18 patients on Day 7 . The mean MDAS score significantly decreased from 14 ( Day 0 ) to 6.4 and 3.6 ( Days 3 and 7 , respectively , P < 0.001 ) . Pain scores significantly decreased from 2.2 ( Day 0 ) to 1.3 and 1.1 on the categorical verbal scale ( Days 3 and 7 , respectively , P < 0.001 ) ; from 2.6 ( Day 0 ) to 1.6 and 1.3 on the STAS ( Days 3 and 7 , respectively , P < 0.001 ) . Symptom scores of dry mouth , nausea , and vomiting significantly decreased , and performance status significantly improved . Opioid rotation from morphine to fentanyl may be effective in alleviating delirium and pain in cancer patients with morphine-induced delirium Patients with cancer often are rotated from other opioids to methadone to improve the balance between analgesia and side effects . To the authors ' knowledge , no clear guidelines currently exist for the safe and effective rotation from transdermal fentanyl to methadone PURPOSE The aim of this study was to examine the clinical effects of switching from transdermal ( TTS ) fentanyl to methadone , or vice versa , in patients with a poor response to the previous opioid . PATIENTS AND METHODS A prospect i ve study was carried out on 31 patients who switched from TTS fentanyl to oral methadone , or vice versa , because of poor opioid response . A fixed conversion ratio of fentanyl to methadone of 1:20 was started and assisted by rescue doses of opioids , and then doses were changed according to clinical response . Pain and symptom intensity , expressed as distress score , were recorded before switching doses of the two opioids and after subsequent doses . The number of changes of the daily doses , time to achieve stabilization , and hospital stay were also recorded . RESULTS Eighteen patients were switched from TTS fentanyl to methadone , and seven patients were switched from methadone to TTS fentanyl . A significant decrease in pain and symptom intensity , expressed as symptom distress score , was found within 24 hours after switching took place in both directions . Unsuccessful switching occurred in six patients , who were subsequently treated with an alternative therapy . CONCLUSION A rapid switching using an initial fixed ratio of fentanyl to methadone of 1:20 is an effective method to improve the balance between analgesia and adverse effects in cancer patients with poor response to the previous opioid . No relationship between the final opioid dose and the dose of the previous opioid has been found & NA ; The successful use of methadone in cancer pain has been supported by numerous case reports and clinical studies . Methadone is usually used as a second or third line opioid medication . \n Output:\n " }, { "from": "agent", "value": "Pain intensity was significantly reduced in the majority of studies .\nSerious adverse effects were improved ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study was to determine the adherence to oral hypoglycemic medications and associated factors in type 2 Diabetes Mellitus patients who were referred to the Isfahan Endocrinology and Metabolism Research Centre ( IEMRC ) . Convenience sampling was used to enroll 248 patients with type 2 diabetes in a prospect i ve study at IEMRC from January 2007 to January 2008 . Patients had to be on a stable dose of oral hypoglycemic medications ( glyburide and metformin ) or for 3 months prior to the study and willing to participate in consultation sessions with a pharmacist . Pill count and self report methods were used to measure the adherence . Mean ( SD ) of patients studied was 56.6 ( 8.9 ) years and 62 % were females . The mean ( SD ) duration of diabetes in the study patients was 10.8 ( 6.1 ) years and 81.9 % of them were literate with basic education . Non-adherence rates to metformin and glyburide were recorded in 39.7 % and 35.3 % of the study population respectively . Lower HbA1C levels and higher education were associated with higher adherence rates . Forgetfulness , confusion , fasting , adverse effects , complexity of medication regimen and disruption of routines were most commonly reported causes of non adherence . Prevalence of adherence to these two medications did not differ significantly between pill count ( 62.3 % ) and self report ( 62.8 % ) , ( p > 0.05 ) . Adherence rates did not vary by pill count and self report significantly . It was concluded that good adherence to medications was associated with a lower HbA1C profile ; so it seems that pill count is a useful method in the clinical practice to identify non-adherent patients . Further studies are needed to find out efficient interventions to improve the patient ’s adherence Background : There have been a number of studies relating medication adherence to patient characteristics . There is less research on influence of health care providers on patients ’ medication-taking behavior . Objectives : To evaluate the pharmacy-level effect on medication adherence for patients receiving antidiabetic medications . Research Design : This was a hypothesis-driven retrospective study using cross-sectional design and insurance cl aims data . The main analytical interest was the pharmacy-level effect on proportion of days covered as the measure of medication adherence . Multilevel r and om and mixed-effect models were used to tease out the pharmacy-level effect on patient outcomes . Subjects : The study population consisted individuals aged 18–64 years , insured under employer-sponsored private health plans . Results : We estimated models with and without covariates . In both models , pharmacy cluster effect was statistically significant ( P<0.001 ) . In the model without covariates , pharmacy cluster effect accounted for 12.8 % ( 95 % confidence interval , 12.4%–13.1 % ) of total variance in adherence , whereas in the model with covariates pharmacies accounted for 12.1 % ( 95 % confidence interval , 11.6%–12.4 % ) of total variance . Covariates associated significantly with adherence were age , sex , mail order pharmacy , and prescription drug copay . Conclusions : The results suggest significant variation in medication adherence attributable to pharmacy factor , independent of other effects . The underlying reason could be varying level of influence from pharmacies ’ efforts to inform or influence patients to take medications in prescribed manners . More research is necessary to better underst and the effect of specific pharmacy characteristics and practice styles differences OBJECTIVE To evaluate the psychosocial barriers to insulin use in low-income , type 2 diabetic patients ; the clinical characteristics of these patients ; and the possible causes of nonadherence to insulin regimens months after prescription . METHODS We studied a prospect i ve cohort of low-income patients with type 2 diabetes mellitus , aged 45 to 75 years , attending a tertiary health care center in Mexico City , Mexico . Patients were eligible if their diabetes was not controlled with oral agents , and they were excluded if they had type 1 diabetes mellitus , a secondary cause of diabetes , had been admitted to the hospital within the month before study commencement , had been previously treated with insulin , had severe diabetic complications , or had a chronic or disabling medical illness . All patients were prescribed 6 to 10 units of neutral protamine Hagedorn insulin before bedtime and received a referral to visit with a diabetes nurse educator . The main outcome was adherence or nonadherence to insulin therapy , and it was correlated with several variables including attitudes toward insulin , diabetes self-management , diabetes-related knowledge , depression , and diabetes-related distress . Brief medical history , complete battery of question naires , and laboratory workup were obtained at baseline and 1 to 3 months after insulin prescription . RESULTS Twenty-nine consecutive patients were included . Mean age ( + /- st and ard deviation ) was 59 + /- 8 years , 18 ( 62 % ) were women , mean diabetes duration was 14 + /- 9 years , and mean hemoglobin A1c level was 10.8 + /- 1.4 % . Negative attitudes toward insulin were very common , particularly in patients with less education and poorer diabetes-related knowledge ( odds ratio , 6.2 ; 95 % confidence interval , 1.04 - 47.3 ; P = .02 ) . Even when they received precise recommendations , 12 patients ( 41 % ) did not adhere to insulin treatment . Patients who did not adhere to therapy were most commonly women and were depressed ( P = .05 ) . Improved adherence was significantly associated with the additional support of a diabetes nurse educator ( odds ratio , 6.6 ; 95 % confidence interval , 1.0 - 55.7 ; P = .02 ) . CONCLUSIONS Improving patient perception and acceptance of insulin with the help of diabetes educators can facilitate earlier and more aggressive intervention and thus optimize glycemic control Purpose The purpose of this study is to assess factors related to diabetes medication nonadherence in a sample of predominantly Spanish-speaking Mexican-origin adults residing along the US-Mexico border . Methods As part of a r and omized controlled trial , 302 patients r and omly sample d from a clinic roster completed a baseline interview . Medication nonadherence was assessed with the Morisky Medication Adherence Scale . Consistent with the framework proposed by Venturini et al , four factors were examined : patient-related attributes , drug regimen characteristics and complexity , health status , and patient-provider interaction characteristics . Results Sixty percent of the patients were classified as nonadherent . Men , those who engaged in diabetes control behaviors less frequently , and individuals with depression were more likely to be classified as nonadherent . Among those who were Spanish-dominant , education and self-rated health also were significantly and negatively related to medication adherence ; patients with a high school education or greater and those who more positively rated their health were more likely to be classified as nonadherent compared to those with less than a high school education and those who rated their health as poor . Conclusions Results reflect potentially higher medication nonadherence rates for Latinos with type 2 diabetes living in rural communities along the US-Mexico border . Additionally , this study supports the need to address strategies to support medication adherence , including addressing depression , for diabetes control . Strategies to promote adherence among Latino men are sorely needed , as are strategies to address forgetfulness and carelessness regarding diabetes medicine taking Purpose The purpose of this study was to examine whether integrating depression treatment into care for type 2 diabetes mellitus among older African Americans improved medication adherence , glycemic control , and depression outcomes . Methods Older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice in west Philadelphia were r and omly assigned to an integrated care intervention or usual care . Adherence was assessed at baseline , 2 , 4 , and 6 weeks using the Medication Event Monitoring System to assess adherence . Outcomes assessed at baseline and 12 weeks included st and ard laboratory tests to measure glycemic control and the Center for Epidemiologic Studies Depression Scale ( CES-D ) to assess depression . Results In all , 58 participants aged 50 to 80 years participated . The proportion of participants who had 80 % or greater adherence to an oral hypoglycemic ( intervention 62.1 % vs usual care 24.1 % ) and an antidepressant ( intervention 62.1 % vs usual care 10.3 % ) was greater in the intervention group in comparison with the usual care group at 6 weeks . Participants in the integrated care intervention had lower levels of glycosylated hemoglobin ( intervention 6.7 % vs usual care 7.9 % ) and fewer depressive symptoms ( CES-D mean scores : intervention 9.6 vs usual care 16.6 ) compared with participants in the usual care group at 12 weeks . Conclusion A pilot r and omized controlled trial integrating type 2 diabetes mellitus treatment and depression was successful in improving outcomes among older African Americans . Integrated interventions may be more feasible and effective in real-world practice s with competing dem and s for limited re sources Purpose The purpose of this study was to evaluate the effectiveness of integrative health ( IH ) coaching on psychosocial factors , behavior change , and glycemic control in patients with type 2 diabetes . Methods Fifty-six patients with type 2 diabetes were r and omized to either 6 months of IH coaching or usual care ( control group ) . Coaching was conducted by telephone for fourteen 30-minute sessions . Patients were guided in creating an individualized vision of health , and goals were self-chosen to align with personal values . The coaching agenda , discussion topics , and goals were those of the patient , not the provider . Preintervention and postintervention assessment s measured medication adherence , exercise frequency , patient engagement , psychosocial variables , and A1C . Results Perceived barriers to medication adherence decreased , while patient activation , perceived social support , and benefit finding all increased in the IH coaching group compared with those in the control group . Improvements in the coaching group alone were also observed for self-reported adherence , exercise frequency , stress , and perceived health status . Coaching participants with elevated baseline A1C ( ≥7 % ) significantly reduced their A1C . Conclusions A coaching intervention focused on patients ’ values and sense of purpose may provide added benefit to traditional diabetes education programs . Fundamentals of IH coaching may be applied by diabetes educators to improve patient self-efficacy , accountability , and clinical outcomes PURPOSE The purpose of this study is to characterize the adherence and medication management barriers for adults with poorly controlled type 2 diabetes mellitus ( DM ) ( those with A1c 9 % or above ) and to identify specific adherence characteristics associated with poor diabetes control . METHODS This was a cross-sectional analysis of baseline data from a r and omized , controlled diabetes intervention conducted in University of Washington ( UW ) Medicine Clinics in the greater Seattle , Washington , area . The goal of the original study was to evaluate the effect of a pharmacist intervention on improving diabetes control over 12 months . Evaluation measures for medication adherence included self-reported adherence and medication management challenges using the Morisky question format and difficulty with taking medications for each diabetes medication based on the Brief Medication Question naire . Specific adherence characteristics associated with poor diabetes control ( A1c > 9 % ) were identified using multivariate regression analysis . RESULTS Seventy-seven subjects ( mean A1c , 10.4 % ; mean duration of DM , 7 years ) were studied . The most common adherence challenges included paying for medications ( 34 % ) , remembering doses ( 31 % ) , reading prescription labels ( 21 % ) , and obtaining refills ( 21 % ) . Taking more than 2 doses of DM medication daily ( beta = .78 , SE = 0.32 , P = .02 ) and difficulty reading the DM medication prescription label ( beta = .76 , SE = 0.37 , P = .04 ) were significantly associated with higher hemoglobin A1c . Self-reported adherence was not related to A1c control . CONCLUSIONS In this study , we identified 2 factors that were associated with poorer A1c control . These findings highlight the importance of identifying potential challenges to medication adherence for those with DM and providing support to minimize or resolve these barriers to control Background Adherence to prescribed medications is a key dimension of healthcare quality . The aim of this large population -based study was to evaluate self-reported medication adherence and to identify factors linked with poor adherence in patients with type 2 diabetes in France . Methodology The ENTRED study 2007 , a French national survey of people treated for diabetes , was based on a representative sample of patients who cl aim ed reimbursement for oral hypoglycaemic agents and /or insulin at least three times between August 2006 and July 2007 , and who were r and omly selected from the data base of the two main National Health Insurance Systems . Medication adherence was determined using a six-item self-administered question naire . A multinomial polychotomous logistic regression model was used to identify factors associated with medication adherence in the 3,637 persons with type 2 diabetes . Principal Findings Thirty nine percent of patients reported good medication adherence , 49 % medium adherence and 12 % poor adherence . The factors significantly associated with poor adherence in multivariate analysis were socio-dem \n Output:\n " }, { "from": "agent", "value": "Factors including age , race , health beliefs , medication cost , co-pays , Medicare Part D coverage gap , insulin use , health literacy , primary nonadherence , and early nonpersistence significantly affect adherence .\nHigher adherence was associated with improved glycemic control , fewer emergency department visits , decreased hospitalizations , and lower medical costs .\nAdherence was lower when medications were not tolerated or were taken more than twice daily , with concomitant depression , and with skepticism about the importance of medication .\nIntervention trials show the use of phone interventions , integrative health coaching , case managers , pharmacists , education , and point-of-care testing improve adherence ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Patients with Parkinson disease ( PD ) may present with various types of pain . In some instances , no cause can be identified and pain is considered a primary disorder ( primary central pain [ PCP ] ) . We hypothesized that PCP in patients with PD ( PD-PCP ) may be due to a dysfunction of pain pathways or the processing of pain inputs in the CNS . Methods : We carried out a psychophysical and neurophysiologic study in 9 patients with PD-PCP , 9 patients with PD without pain ( PD-NoP ) , and 9 healthy control subjects . We assessed the clinical characteristics of pain , performed quantitative sensory testing with thermal probes , and recorded laser-evoked potentials ( LEPs ) and laser-induced sudomotor skin responses ( l-SSRs ) in “ off ” and “ on ” conditions . Results : In “ off ” condition , patients with PD-PCP had lower heat pain and laser pinprick thresholds , higher LEP amplitudes , and less habituation of the l-SSR in comparison with PD-NoP patients and control subjects . Abnormalities were more marked in the most affected side . In “ on ” condition , psychophysical and neurophysiologic differences disappeared or were significantly attenuated . Conclusion : Conduction along peripheral and central pain pathways is normal in patients with Parkinson disease with or without primary central pain . However , apart from signs of hyperalgesia , our patients exhibited lack of habituation of sympathetic sudomotor responses to repetitive pain stimuli , suggesting an abnormal control of the effects of pain inputs on autonomic centers . Abnormalities were attenuated by l-dopa , suggesting that the dysfunction may occur in dopamine-dependent centers regulating both autonomic function and inhibitory modulation of pain inputs To examine the effects of levodopa ( L-dopa ) and deep brain stimulation of the subthalamic nucleus ( STN-DBS ) on sensory symptoms and signs in Parkinson 's disease ( PD ) . Seventeen patients with PD were included . ( 1 ) Presence of sensory symptoms and ( 2 ) effects of L-dopa and STN-DBS on sensory symptoms and signs [ assessed by quantitative sensory testing ( QST ) ] were examined 6 months after starting STN-DBS . In addition , in 12 of these patients , presence of sensory symptoms prior and post STN-DBS was compared . Pain was most frequently nociceptive . In about 30 - 40 % , pain and sensory symptoms were associated with PD motor symptoms . In most of these cases , pain responded to L-dopa . Intensity of pain was reduced post STN-DBS compared to pre STN-DBS . L-Dopa had no influence on detection thresholds , whereas STN-DBS improved thermal detection thresholds . However , thermal and mechanical pain thresholds were uninfluenced by L-dopa or STN-DBS . Although some patients reported an improvement of pain with STN-DBS or L-dopa , objective ly pain sensitivity as assessed by QST was not altered by STN-DBS or L-dopa suggesting that there is no evidence for a direct modulation of central pain processing by L-dopa or STN-DBS Plastic changes within the striatum result ing from pulsatile dopaminergic stimulation are thought to lead to dyskinesia in patients with Parkinson 's disease ( PD ) . The basal ganglia play a role in processing pain . We hypothesized that the plastic changes that lead to dyskinesia may also mediate pain responses . Our objective was to compare the change in pain sensitivity after levodopa administration between stable responders , fluctuators without dyskinesia , and dyskinetic patients , and to compare pain sensitivity between PD and healthy subjects . Fifty patients with PD were assessed with cold water immersion after overnight withdrawal of dopaminergic medications and again after a st and ard levodopa challenge , and carefully classified into stable responder ( n = 12 ) , fluctuator ( n = 15 ) , and dyskinetic ( n = 23 ) groups . Twenty age-matched controls were also tested . PD patients \" off\"-medication had a lower threshold ( P = 0.016 ) and tolerance ( P < 0.0001 ) to cold pain compared to controls . After levodopa administration , dyskinetic patients experienced a large increase in cold pain threshold ( 48 % ) and tolerance ( 66 % ) that was absent in stable responders ( P = 0.038 and P = 0.015 ) ; there was no significant difference in pain sensitivity change scores between the fluctuator and either the stable responder or dyskinetic groups . Our results suggest that dyskinesia and pain may share common pathophysiological mechanisms in PD Background : Patients suffering from Parkinson ’s disease ( PD ) describe painful sensations that could be related to neuropathic pain . Experimental data have indicated the involvement of basal ganglia and dopaminergic pathways in central nociceptive processing . Aim : The objective of this study was to assess and compare the effect of levodopa on the objective pain threshold in patients with PD and healthy subjects . Methods : The objective pain threshold was assessed by the nociceptive flexion reflex ( RIII ) in 13 PD patients and 10 healthy subjects . Patients and healthy subjects were evaluated under two r and omised conditions : with levodopa ( ON ) and without ( OFF ) . Results : Levodopa significantly increased the RIII threshold of PD patients ( 6.9 ( 1.2 ) mA in the OFF condition vs 8 ( 1.1 ) mA in the ON position ; p = 0.02 ) . RIII threshold was significantly lower in PD patients than in healthy subjects in the OFF condition ( 6.9 ( 1.2 ) mA vs 9.7 ( 3.4 ) mA ; p = 0.02 ) . RIII threshold did not change after levodopa administration in healthy subjects . Conclusion : These results provide evidence of a dopaminergic modulation of objective pain threshold in PD patients . In addition , the decrease in RIII threshold in PD patients , in the OFF condition , compared with controls , confirms the existence of an objective pain perception disturbance in PD BACKGROUND Patients suffering from Parkinson 's disease ( PD ) frequently experience painful sensations that may be due to central modification of nociception in PD . We compared pain thresholds and cerebral activity in nociceptive areas using Positron Emission Tomography ( PET ) during nociceptive stimulation before ( OFF condition ) and after ( ON condition ) levodopa challenge between nine PD patients with and nine PD patients without neuropathic pain . METHODS Pain thresholds were determined using a cold pressor test in the two conditions . We used H2(15)O PET to study the regional cerebral blood flow changes in subjects while they received alternate r and omized noxious and innocuous cold stimuli during OFF and ON periods . RESULTS Pain thresholds were not significantly different between PD patients with and without pain in either condition ( OFF and ON ) . In both groups of PD patients , levodopa significantly raised pain threshold ( F1,16 = 26.71 ; p < 0.0001 ) with a mean variation of -2.7 ( ±2.3 ° C ) . In the OFF condition , PD patients with pain had a lower pain activation in the right prefrontal cortex and posterior insula and a higher pain activation in the right anterior cingulate cortex ( BA32/8 ) than pain-free patients . Levodopa significantly reduced pain-induced-activation in the right insula and in the anterior cingulate cortex in both groups . CONCLUSION Levodopa decreased nociceptive perception in both PD patients with and without pain . In PD patients with neuropathic pain the medial affective pathway was preferentially recruited whereas pain-free PD patients exhibited a greater activation in lateral discriminative nociceptive areas INTRODUCTION Trigemino-cervical-spinal reflexes ( TCSRs ) are complex brainstem stereotyped nociceptive responses involved in a defensive withdrawal reaction of the head from facial nociceptive stimuli . OBJECTIVE The present study was undertaken to collect data on possible TCSR abnormalities in idiopathic Parkinson 's disease ( PD ) and investigate any correlation with motor signs and L-DOPA administration . METHODS TCSRs were registered from the semispinalis capitis and biceps brachii muscles after electrical stimulation of the supraorbital nerve in 18 patients with PD and 24 controls . The latency ( L ) and area ( A ) , as well as the sensory ( ST ) , painful ( PT ) and reflex ( RT ) thresholds were measured during the ' off ' and ' on ' state , and possible correlations with the UPDRS III total score , selected subscores ( tremor , neck rigidity , upper limb rigidity , akinesia , rising from a chair , posture and posture instability ) and duration of illness were investigated . RESULTS Significant changes between controls and PD patients were found in the L , A , PT and RT of TCSRs . These results were not significantly influenced by L-DOPA treatment . A significant correlation was found between neck rigidity , postural instability scores and duration of illness and the TCSR L and A values in PD patients in the ' off ' state . CONCLUSIONS TCSRs abnormalities , combined with dopamine resistance , are consistent with a primary loss of brainstem neurons mediating a complex sensory-motor integration including neck muscle tone and postural control as well as the head withdrawal reaction to the nociceptive stimuli . SIGNIFICANCE TCSRs may represent a useful tool for the assessment of brainstem sensory-motor function in PD as well as other movement and degenerative disorders OBJECTIVE To assess levodopa dose effect on pain thresholds in Parkinson 's disease ( PD ) patients using an experimental nociceptive thermal stimulation . PATIENTS AND METHODS We evaluated pain thresholds in 20 PD patients treated by dopaminergic drugs . We assessed heat and cold pain thresholds by using 2 different methods ( method of limits and method of levels ) , intensity-response curve and tolerance threshold . Each PD patient was evaluated in two conditions : ON ( after administration of leovdopa and OFF ( after acute levodopa withdrawal ) . The order was r and omized . RESULTS The mean age of patients was 652+/-9.9 years and the mean duration was 9.3+/-3.3 years . Heat pain thresholds were statistically higher in ON versus OFF condition using both methods ( 44.1+/-3,6 degrees C versus 42.3+/-3,1 degrees C , method of levels , p=0.02 ) . Cold pain thresholds were statistically higher in ON versus OFF condition only using method of levels ( 17.9+/-4,4 degrees C versus 19.6+/-4,2 degrees C , p=0.02 ) . Heat pain tolerance was statistically higher in ON versus OFF condition ( 21.4+/-21.6 seconds versus 14.7+/-20.3 seconds , p=0.02 ) . CONCLUSION This study showed that levodopa increased heat and cold pain thresholds and heat pain tolrance in PD patients . This suggests that dopaminergic drugs could have an analgesic effects on PD related pain Patients suffering from Parkinson 's disease ( PD ) frequently experienced painful sensations that could be in part due to central modification of nociception . We compared pain threshold before and after administration of levodopa in PD patients and in controls , and investigated cerebral activity with positron emission tomography ( PET ) during experimental nociceptive stimulation . Pain threshold was determined using thermal stimulation during two r and omized conditions : off and on . We performed H(2 ) (15)O PET analysis of regional cerebral blood flow on subjects while they received alternate r and omized noxious and innocuous stimuli during off and on conditions . In off condition , pain threshold in nine PD patients was significantly lower than in nine controls . Administration of levodopa significantly raised pain threshold in PD patients but not in controls . During off condition , there was a significant increase in pain-induced activation in right insula and prefrontal and left anterior cingulate cortices in PD compared to control group . Levodopa significantly reduced pain-induced activation in these areas in PD . This study shows that pain threshold is lower in PD patients but returns to normal ranges after levodopa administration . Moreover , PD patients have higher pain-induced activation in nociceptive pathways , which can be reduced by levodopa Patients with Parkinson 's disease ( PD ) frequently experience pain that could be in part due to central modification of nociception . In this r and omized controlled double blind study , we compared the effect of apomorphine versus placebo on pain thresholds and pain-induced cerebral activity in 25 patients with PD . Subjective pain threshold ( using thermal stimulation , thermotest ) , objective pain threshold ( nociceptive flexion reflex ) , and cerebral activity ( H(2)(15)O PET ) during noxious and innocuous stimulations were performed . Neither subjective nor objective pain thresholds nor pain activation profile were modified by apomorphine compared with placebo in 25 PD patients . Apomorphine has no effect on pain processing in PD . We suggest that other monoamine systems than dopaminergic system could be involved Objective : To investigate the acute effect of subthalamic nuclei deep brain stimulation ( STN-DBS ) and levodopa on pain and tolerance thresholds in patients with Parkinson disease . We hypothesized that a modification of pain threshold after STN-DBS would suggest a central modification of pain perception , whereas the absence of pain threshold change after STN-DBS would correspond to a peripheral mechanism via a decrease of painful stimuli . Methods : Nineteen patients with Parkinson disease were included in this double-blind , r and omized , crossover study . Postoperatively , we \n Output:\n " }, { "from": "agent", "value": "Results were much more heterogenous when PD patients on medications were compared with HC off medications , with most trials reporting no significant difference in pain thresholds between groups .\nNo significant differences were found in pain thresholds for trials that compared PD patients on medications and HC on medications .\nPD patients are more sensitive to noxious stimuli compared to HC when tested in the off medication state .\nThis increase in pain sensitivity is observed across all modalities , but is not as apparent when PD patients are administered Levodopa , suggesting that dopamine deficient states may contribute to hyperalgesia .\nHowever , it remains to be seen whether or not increased pain sensitivity translates clinical ly into increased prevalence of pain .\nSimilarly , it is unclear if dopaminergic medications influence pain sensitivity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Peripheral sensory neurotoxicity is a frequent and potentially debilitating side effect of oxaliplatin treatment . Calcium and magnesium ( Ca/Mg ) infusions are frequently used to prevent this toxicity . However , concerns about a negative impact of Ca/Mg infusions on outcome have been raised . We retrospectively assessed the effect of Ca/Mg infusions on the incidence of neurotoxicity and on clinical outcome in advanced colorectal cancer ( ACC ) patients treated in the phase III CAIRO2 study . MATERIAL S AND METHODS Seven hundred and fifty five previously untreated ACC patients were r and omised between treatment with capecitabine , oxaliplatin and bevacizumab or the same combination with the addition of cetuximab . Patients were retrospectively divided into two groups : patients in the Ca/Mg(+ ) group received Ca/Mg at least during their first treatment cycle , and patients in the Ca/Mg(- ) group did not . RESULTS Seven hundred and thirty two patients were evaluable for this analysis . The Ca/Mg(+ ) group consisted of 551 patients , the Ca/Mg(- ) group consisted of 181 patients . The incidence of all grade neurotoxicity in the Ca/Mg(+ ) group and the Ca/Mg(- ) group was 85 % and 92 % , respectively ( p = 0.02 ) , and the incidence of grade ≥ 2 neurotoxicity was 40 % and 45 % , respectively ( p = 0.22 ) . The median PFS in the Ca/Mg(+ ) versus Ca/Mg(- ) group was 10.1 versus 10.7 months ( p = 0.92 ) , the median OS was 19.8 versus 20.7 months ( p = 0.10 ) , and the response rate was 43.1 % versus 50 % ( p = 0.11 ) , respectively . CONCLUSIONS In this largest retrospective analysis to date we observed that Ca/Mg infusions significantly reduced all grade oxaliplatin-related neurotoxicity . Ca/Mg infusions did not affect the clinical efficacy of treatment Meta-analytic investigations sometimes use assessment s of research quality according to a formal protocol as a tool for improving research synthesis . We asked whether a particular quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference . In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled r and omized clinical trials comprising 107 primary studies , we found no relation between treatment difference and overall quality score . We also found no relation between quality score and variation in treatment difference . The level of quality scores has increased at a rate of 9 % per decade for three decades , averaging 0.51 on a scale of 0 to 1 for the 1980s , and leaving much room for improvement . Nevertheless , attention to quality of studies by editors , review ers , and authors may be raising both the level of research done and quality of the reports BACKGROUND Oxaliplatin , a platinum compound , has been commonly used around the world for treating advanced colorectal cancer . The generally recommended dose and schedule of oxaliplatin monotherapy is 130 mg/m(2 ) every 3 weeks . This trial was conducted to evaluate the safety and pharmacokinetics of oxaliplatin monotherapy in Japanese patients with solid tumors . METHODS Oxaliplatin was administered as a 2-h intravenous infusion every 3 weeks at a dose of 90 and 130 mg/m(2 ) . Blood was collected to determine the total platinum and the ultrafiltrate platinum concentrations in plasma in all cycles . RESULTS Nine patients were enrolled ; three were given oxaliplatin monotherapy at 90 mg/m(2 ) and six received 130 mg/m(2 ) . All tumors were colorectal cancer . The major adverse reactions included myelosuppressive , neurological and gastrointestinal toxicities , although most were grade s 1 and 2 at both dose levels . Peripheral sensory neuropathy of without movement disturbance ( grade 1 or 2 ) was observed in all patients at both dose levels . The 130 mg/m(2 ) dose level was not found to be the maximum tolerated dose , but was judged to be the recommended dose . No objective responses were seen and five cases of no change were observed . A bi-exponential open model best described the disappearance of platinum in the plasma , and a tri-exponential open model best described the disappearance of ultrafilterable platinum in the plasma at both dose levels . No racial difference was suggested in the pharmacokinetics of oxaliplatin . CONCLUSIONS The oxaliplatin monotherapy dose schedule of 130 mg/m(2 ) every 3 weeks , recommended worldwide , is acceptable for Japanese patients Aim : Oxaliplatin‐related neurotoxicity is frequently dose‐limiting . Following retrospective studies suggesting neuroprotective effects of calcium and magnesium ( Ca and Mg ) , we conducted a prospect i ve study using nerve conduction studies ( NCS ) to evaluate the effectiveness of such infusions in oxaliplatin‐related neuropathy Background Whether the administration of calcium ( Ca ) and magnesium ( Mg ) can reduce oxaliplatin-related neurotoxicity remains controversial . In addition , little is known about the effects of Ca/Mg on the blood level of platinum or objective tumor progression . Patients and methods Patients receiving modified FOLFOX6 for metastatic colorectal cancer were double-blinded and r and omized to receive additional treatment with Ca/Mg or placebo before and after the administration of oxaliplatin . The plasma and ultrafiltrable concentrations of platinum during the first and fifth cycles of treatment were determined using inductively coupled plasma spectrometry . Results Patients were r and omized to receive Ca/Mg ( Ca/Mg group , n = 17 ) or placebo ( placebo group , n = 16 ) before and after the administration of oxaliplatin ( 85 mg/m2 ) . The incidence of neurotoxicity after six cycles was not significantly different between the two groups . Blood concentrations of platinum at each time and the area under the curve were also not significantly different between the two groups . Furthermore , the response rate ( RR ) and disease control rate ( DCR ) did not differ significantly between the two groups ( Ca/Mg group : RR 36 % , DCR 73 % . Placebo group : RR 40 % , DCR 70 % , P > 0.99 ) . The median progression-free survival time was 9.2 months in the Ca/Mg group and 8.1 months in the control group ; these survival times were not significantly different ( P = 0.56 ) . Conclusion These data are insufficient to conclude with any certainty that the administration of Ca/Mg is not neuroprotective ; however , the administration of Ca/Mg may not have any influence on antitumor activity and the blood concentration profile of platinum in patients receiving oxaliplatin-based chemotherapy BACKGROUND The st and ard adjuvant treatment of colon cancer is fluorouracil plus leucovorin ( FL ) . Oxaliplatin improves the efficacy of this combination in patients with metastatic colorectal cancer . We evaluated the efficacy of treatment with FL plus oxaliplatin in the postoperative adjuvant setting . METHODS We r and omly assigned 2246 patients who had undergone curative resection for stage II or III colon cancer to receive FL alone or with oxaliplatin for six months . The primary end point was disease-free survival . RESULTS A total of 1123 patients were r and omly assigned to each group . After a median follow-up of 37.9 months , 237 patients in the group given FL plus oxaliplatin had had a cancer-related event , as compared with 293 patients in the FL group ( 21.1 percent vs. 26.1 percent ; hazard ratio for recurrence , 0.77 ; P=0.002 ) . The rate of disease-free survival at three years was 78.2 percent ( 95 percent confidence interval , 75.6 to 80.7 ) in the group given FL plus oxaliplatin and 72.9 percent ( 95 percent confidence interval , 70.2 to 75.7 ) in the FL group ( P=0.002 by the stratified log-rank test ) . In the group given FL plus oxaliplatin , the incidence of febrile neutropenia was 1.8 percent , the incidence of gastrointestinal adverse effects was low , and the incidence of grade 3 sensory neuropathy was 12.4 percent during treatment , decreasing to 1.1 percent at one year of follow-up . Six patients in each group died during treatment ( death rate , 0.5 percent ) . CONCLUSIONS Adding oxaliplatin to a regimen of fluorouracil and leucovorin improves the adjuvant treatment of colon cancer OBJECTIVE To assess the efficacy of calcium-magnesium ( Ca/Mg ) infusion and glutathione ( GSH ) for preventing the neurotoxicity induced by oxaliplatin . METHODS This is a r and omized , double blind , placebo controlled clinical trail . The patients receiving FOLFOX4 chemotherapy for their solid tumor were r and omized to receive Ca/Mg , GSH or normal saline with chemotherapy simultaneously . The incidence and severity of oxaliplatin-induced neurotoxicity were observed . The ECOG performance status was recorded and compared among the 3 groups . RESULTS Ninety-three patients admitted in our department from Mar 2006 to Dec 2007 were entered into this study , including 29 patients in the Ca/Mg group , 33 in the GSH group and 31 in the chemotherapy alone group . The incidences of acute neurotoxicity were 82.8 % , 90.9 % and 93.5 % , respectively . At the third cycle , the incidences of grade 1 - 2 chronic neurotoxicity were 37.9 % , 48.5 % and 42.0 % , respectively . No grade 3 neuropathy was observed . After 6 cycles , the incidence of grade 1 - 2 neuropathy was increased to 68.2 % , 88.9 % and 85.2 % , respectively . A lower percentage was observed in Ca/Mg arm without a statistically significant difference , and grade 3 neuropathy occurred in 5 patients . After 9 cycles , the incidence of grade 1 - 2 neuropathy was increased to 81.3 % , 90.0 % and 92.9 % , respectively . Grade 3 neuropathy occurred in another 2 patients . No statistically significant difference was observed among the 3 arms . Changes of patient 's ECOG score after chemotherapy were similar . CONCLUSION This study did n't provide evidence that Ca/Mg infusion and GSH can prevent the oxaliplatin-induced neurotoxicity Oxaliplatin , a platinum-based chemotherapeutic agent , is effective in the treatment of solid tumors , particularly colorectal cancer . During and immediately following oxaliplatin infusion , patients may experience cold-induced paresthesias , throat and jaw tightness , and occasionally focal weakness . We assessed nerve conduction studies and findings on needle electromyography of patients with metastatic colorectal cancer before and during treatment with oxaliplatin . Twenty-two patients had follow-up studies within 48 h following oxaliplatin infusions , and 14 patients had follow-up studies after 3 - 9 treatment cycles . Repetitive compound muscle action potentials and neuromyotonic discharges were observed in the first 24 - 48 h following oxaliplatin infusion , but resolved by 3 weeks . After 8 - 9 treatment cycles , sensory nerve action potential amplitudes declined , without conduction velocity changes or neuromyotonic discharges . The acute neurological symptoms reflect a state of peripheral nerve hyperexcitability that likely represents a transient oxaliplatin-induced channelopathy . Chronic treatment causes an axonal neuropathy similar to other platinum-based chemotherapeutic agents PURPOSE Cumulative sensory neurotoxicity ( sNT ) is the dose-limiting toxicity of oxaliplatin , which commonly leads to early discontinuation of oxaliplatin-based therapy in the palliative and adjuvant setting s. In a nonr and omized , retrospective study , intravenous ( IV ) calcium/magnesium ( Ca/Mg ) was associated with reduced oxaliplatin-induced sNT . METHODS Patients with colon cancer undergoing adjuvant therapy with infusional fluorouracil , leucovorin , and oxaliplatin ( FOLFOX ) were r and omly assigned to Ca/Mg ( 1 g calcium gluconate plus 1 g magnesium sulfate pre- and post-oxaliplatin ) or placebo , in a double-blinded manner . The primary end point was the percentage of patients with grade 2 or greater sNT at any time during or after oxaliplatin-based therapy by National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI CTCAE ; version 3 ) criteria . An oxaliplatin-specific sNT scale and patient question naires were also used to assess sNT . After 104 of 300 planned patients were enrolled , the study was closed . This was due to preliminary reports from another trial that suggested that Ca/Mg decreased treatment efficacy ; these data were subsequently found to be incorrect . RESULTS Overall , 102 patients were available for analysis . Ca/Mg decreased the incidence of chronic , cumulative , grade 2 or greater sNT , as measured by NCI CTCAE ( P = .038 ) and also by the oxaliplatin-specific sNT scale ( P = .018 ) \n Output:\n " }, { "from": "agent", "value": "On the other h and , our results support the hypothesis that administrations of Ca/Mg do not impair the efficacy of oxaliplatin-based chemotherapy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to evaluate the effect of maternal use of chewing gums containing combinations of xylitol , sorbitol , chlorhexidine , and fluoride on salivary mutans streptococci ( MS ) counts and caries prevalence in the mothers ' 3-year-old children . After screening 416 women with newborn babies , 173 mothers with high counts of salivary MS were r and omly assigned into 3 experimental chewing gum groups containing ( A ) xylitol ( n=61 ) , ( B ) chlorhexidine/xylitol/sorbitol ( n=55 ) , and ( C ) sodium fluoride/xylitol/sorbitol ( n=57 ) . Mothers with low or medium MS counts formed a reference group ( D ) without any intervention ( n=232 ) . The participants in the experimental groups were instructed to chew one piece of the gum for 5 min 3 times a day . The chewing regimen started when the child was 6 months old and was terminated 1 year later . The outcome measures were salivary MS counts and caries prevalence at the age of 3 years . Bacterial enumeration was carried out with a chair-side technique and caries ( defs ) was scored by clinical examination . Medium and high counts of salivary MS were found in 13 % , 16 % , and 22 % in groups A , B , and C , respectively . The mean defs was 0.1 in group A , 0.2 in group B , and 0.4 in group C. The differences concerning salivary MS and caries were not statistically significant . The MS counts and caries prevalence in children of mothers with low MS counts ( group D ) were similar to those found in groups A and B. In conclusion , lower but non-significant levels of salivary MS and dental decay were observed in 3-year-old children to mothers who used high-content xylitol gums compared with those who used lower amounts of xylitol . The efficiency of this type of targeted intervention in a low-caries community may be question ed Background Maaori are the Indigenous people of New Zeal and and do not enjoy the same oral health status as the non-Indigenous majority . To overcome oral health disparities , the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants . The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child . This study seeks to determine whether implementing a kaupapa Maaori ( Maaori philosophical viewpoint ) in an early childhood caries ( ECC ) intervention reduces dental disease burden among Maaori children . The intervention consists of four approaches to prevent early childhood caries : dental care provided during pregnancy , fluoride varnish application to the teeth of children , motivational interviewing , and anticipatory guidance . Methods / design The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui . This r and omised-control trial will be undertaken utilising the principles of kaupapa Maaori research , which encompasses Maaori leadership , Maaori relationships , Maaori customary practice s , etiquette and protocol . Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention . Self-report information will be collected in a baseline question naire during pregnancy and when children are aged 24 and 36 months . Clinical oral health data will be collected during st and ardised examinations at ages 24 and 36 months by calibrated dental professionals . All participants receive the ECC intervention benefits , with the intervention delayed by 24 months for participants who are r and omised to the control-delayed arm . Discussion The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research processes . This study will assess an ECC intervention which could provide a meaningful approach for Maaori for the protection and maintenance of oral health for Maaori children and their family , thus reducing oral health disparities . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN12611000111976 Background Poor oral health , such as periodontal ( gum ) disease , has been found to be associated with an increased risk of adverse pregnancy outcomes including preterm birth , low birth weight , and neonatal and infant mortality , especially in low- and middle-income countries . However , there is little or no access to preventive dental care in most low- and middle-income countries . We propose to develop and test a “ Mouth Rinse Intervention ” among pregnant women to prevent the progression of periodontal disease during pregnancy and reduce adverse birth and neonatal outcomes in a rural county of China . Methods / Design This is a r and omized controlled clinical trial . A sample of 468 ( 234 in each arm of the study ) women in early pregnancy with periodontal disease will be recruited for the study . Periodontal disease will be diagnosed through the methods of Periodontal Screening and Recording . All women diagnosed with periodontal disease will be r and omly allocated into the intervention or control group . Women assigned in the intervention group will be provided with non-alcohol antimicrobial mouth rinse containing cetylpyridinium chloride throughout the pregnancy and oral health education . Women in the control group will receive a package of tooth brush and paste , plus oral hygiene education . Women will be followed-up to childbirth until the 42nd day postpartum . The main outcomes include mean birthweight ( gram ) and mean gestational age ( week ) . Discussion Compared with conventional mechanical ‘ scaling and root planning ’ periodontal treatment during pregnancy , our proposed mouth rinse intervention could be a simple , cost-effective , and sustainable solution to improve both mother ’s oral health and neonate outcomes . If the mouth rinse is confirmed to be effective , it would demonstrate great potential for the application in other low- or middle-income countries to prevent adverse birth outcomes such as preterm birth and low birth weight and to reduce neonatal and infant mortality . Trial registration This trial was registered with Chinese Clinical Trial Registry ( ChiCTR ) : ( # ChiCTR-TRC-13003768 ) on November 06 , 2013 A long-term prospect i ve , r and omized dietary intervention to prevent exposure of children to the known atherosclerosis risk factors ( the STRIP baby project ) was started when the age of the children was 7 months . The aim of this sub study was to analyze the oral effects of the dietary intervention in the children and their parents when the children had reached the age of 3 years . Every fifth family of the main study was invited to this sub study ( n = 179 ) . Those studied ( n = 148 ) represented well the intervention and the control groups and both genders in terms of intake of saturated fatty acids , the dietary polyunsaturated fatty acid to saturated fatty acid ( PUFA/SAFA ) ration and serum cholesterol and HDL cholesterol concentrations . Though no difference was found in sucrose consumption between the intervention and the control groups , the intervention children received relatively ( in E% ) more energy from carbohydrates than the control children ( p < 0.005 ) , used absolutely ( in g ) and relatively ( in E% ) less fat ( p < 0.05 ) and had a higher PUFA/SAFA ratio in their diet ( p < 0.001 ) . Of the 3-year-old children 93 % were caries free , and dental decay was a prevalent in the intervention as in the control children . Control children brushed their teeth unassisted more often than the intervention children ( p < 0.05 ) . The intervention fathers also received more energy ( in E% ) from carbohydrates ( p < 0.01 ) , the intervention mothers used less fat ( p < 0.05 ) and had a higher PUFA/SAFA ratio in the diet ( p < 0.05 ) than the control fathers and mothers , respectively . Dental and periodontal health of the intervention and control parents ( n = 250 , 84 % attending , mean + /- SD age : 34.2 + /- 54.5 years also showed no differences even though the control parents had more commonly last visited a dentist over 3 years before this examination ( p < 0.05 ) . We conclude that a 29-month period of a low-saturated-fat , low-cholesterol but high-carbohydrate diet as advocated in the STRIP baby trial does not seem to have harmful effects on the oral health of the children or their parents . Minor untoward differences had occurred in the dental health behavior of the control children and their parents OBJECTIVE To examine the effect of a nutrition and hygiene education intervention on oral health behaviour and whether early onset of caries was related to child growth in rural Ug and a. METHODS Follow-up study of a cluster-r and omised controlled trial conducted between October 2013 and January 2015 . Data were available from 399 mother/child pairs ( 203 in the intervention and 198 in the control group ) of the original trial ( 78 % ) when the children were 36 months old . Oral health behaviour was evaluated using question naires . Photographs of the maxillary anterior teeth were examined for unmistakably carious lesions , and 115 water sample s from the study area were analysed for fluoride concentration . RESULTS The frequency of cleaning of the child 's teeth at 36 months was about twice as high in the intervention as in the control group ( 84.3 % vs. 46.6 % ; P = 0.0001 ) . Cavitated carious lesions occurred more frequently in the control than the intervention group ( 27.8 % vs. 18.2 % ; P = 0.04 ) . Extraction of ' false teeth ' ( ebiino ) , a painful and crude traditional operation , was profoundly reduced in the intervention group ( 8.9 % vs. 24.7 % ; P = 0.001 ) . There was no evidence of association between the occurrence of caries and child growth . CONCLUSIONS The education intervention improved oral hygiene practice s and reduced the development and progression of caries and extraction of ebiino . Early childhood caries was not clearly associated with child growth OBJECTIVE To investigate the impact of an integrated oral health promotion intervention , within the Syrian national immunisation programme , which provided free preventive dental health products , without health workers ' counselling , on one-year-old infants ' tooth-brushing and bottle-feeding termination practice s. RESEARCH DESIGN a r and omised controlled parallel-group trial . SETTING A maternal and child health centre in Sweida city , Syria . PARTICIPANTS 92 mothers of one-year-old infants , attending an infant vaccination clinic , were allocated into three groups : Test , Control One and Control Two . INTERVENTIONS The Test group received an oral health promotion package including an infant oral health pamphlet , a baby toothbrush , fluoride toothpaste ( 1,000 mg/L ) and a trainer cup , without health workers ' counselling . Control One received only the pamphlet , whilst Control Two received no intervention . MAIN OUTCOME MEASURES after one month , the presence of old plaque on infants ' primary teeth was checked , to assess tooth-brushing behaviour . Also , a mothers ' self-completed question naire was administered to assess bottle-feeding use . RESULTS The response rate was 100 % and the attrition rate was zero . There were differences in tooth-brushing and bottle-feeding termination practice s between the three groups ( P⟩0.001 ) . Infants in the Test group were less likely to have old plaque and more likely to stop bottle-feeding than their counterparts in the two control groups . There were no differences in the abovementioned outcomes between the two control groups . CONCLUSIONS Providing free preventive dental health products , without health worker 's counselling , in an integrated oral health promotion intervention , was an effective measure to promote infants ' tooth-brushing and bottle-feeding termination practice s. These findings should be supported by long-term follow up studies BACKGROUND One hypothesis to explain the association between periodontal disease ( PD ) preterm/low birth weight ( PT/LBW ) is that PT/LBW may be indirectly mediated through translocation of bacteria or bacterial products in the systemic circulation . Transient bacteremias occur in subjects with marginal periodontitis or with gingivitis , and it is possible that bacteria and their products may reach the placental membranes hematogenously and provide the inflammatory effect to induce preterm labor . The effect of gingivitis as a potential risk factor for PT/LBW has still not been studied . A r and omized controlled trial was undertaken to determine the effect of routine plaque control and scaling on the pregnancy outcomes in women with gingivitis . METHODS Eight hundred seventy ( 870 ) pregnant women with gingivitis , aged 18 to 42 , were enrolled while receiving prenatal care in Santiago , Chile . Women were r and omly assigned in a two-to-one fashion to either a treatment group ( N = 580 ) , receiving periodontal treatment before 28 weeks of gestation or to a control group ( N = 290 ) , receiving periodontal treatment after delivery . Periodontal therapy consisted of plaque control , scaling , and daily rinsing with 0.12 % clorhexidine . Maintenance therapy was provided every 2 to 3 weeks until delivery , and consisted of oral hygiene instruction and supragingival plaque removal by instrumentation , as needed . The primary outcomes assessed were delivery at less than 37 weeks of gestation or an infant weighing less than 2,500 g \n Output:\n " }, { "from": "agent", "value": "Moderate-certainty evidence suggests that providing advice on diet and feeding to pregnant women , mothers or other caregivers with children up to the age of one year probably leads to a slightly reduced risk of early childhood caries ( ECC ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Dexamethasone was compared with placebo in a double-blind , crossover , r and omised study of infants with severe bronchopulmonary dysplasia who had required mechanical ventilation for at least four weeks , despite treatment with diuretics , methylxanthines , bronchodilators , fluid restriction , nutritional supplementation , and ligation of the patent ductus arteriosus when indicated . Gestational age ranged from 27 to 33 weeks and birth weight from 800 to 1730 g. Patients received dexamethasone ( 0 . 5 mg/kg/day ) or normal saline for the first 3 days , then treatment was crossed over for the next 3 days . The study was terminated when sequential analysis showed that all six patients had improved during dexamethasone therapy . Significant improvements were seen in ventilator-determined respiratory rate , peak inspiratory pressure , fractional inspired oxygen concentration , and alveolar arterial oxygen gradients ( p less than 0 . 05 ) . Although dexamethasone hastened weaning from mechanical ventilation , infection occurred in a substantial proportion of patients BACKGROUND . Low cortisol concentrations in premature infants have been correlated with increased severity of illness , hypotension , mortality , and development of bronchopulmonary dysplasia . A total of 360 mechanically ventilated infants with a birth weight of 500 to 999 g were enrolled in a r and omized , multicenter trial of prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia . Mortality and bronchopulmonary dysplasia were decreased in the hydrocortisone-treated patients exposed to chorioamnionitis . We now report outcomes at 18 to 22 months ' corrected age . PATIENTS AND METHODS . Surviving infants were evaluated with st and ardized neurologic examination and Bayley Scales of Infant Development-II . Neurodevelopmental impairment was defined as a Mental Developmental Index or Psychomotor Developmental Index of < 70 , cerebral palsy , blindness or deafness . RESULTS . A total of 252 ( 87 % ) of 291 survivors were evaluated . Cerebral palsy was diagnosed in 13 % of hydrocortisone-treated versus 14 % of placebo-treated infants . Fewer hydrocortisone-treated infants had a Mental Development Index < 70 , and more of the hydrocortisone-treated infants showed evidence of awareness of object permanence . Incidence of neurodevelopmental impairment was not different ( 39 % [ hydrocortisone ] vs 44 % [ placebo ] ) . There were no differences in physical growth measures . Chorioamnionitis-exposed infants treated with hydrocortisone were shorter and weighed less than controls but had no evidence of neurodevelopmental impairment . Among infants not exposed to chorioamnionitis , hydrocortisone-treated patients were less likely to have a Mental Development Index of < 70 or to be receiving glucocorticoids at follow-up . CONCLUSIONS . Early , low-dose hydrocortisone treatment was not associated with increased cerebral palsy . Treated infants had indicators of improved developmental outcome . Together with the short-term benefit previously reported , these data support additional studies of hydrocortisone treatment of adrenal insufficiency in extremely premature infants OBJECTIVE There is increasing concern in regard to the possible long-term adverse effects of postnatal dexamethasone treatment in preterm infants . The purpose of this study was to assess growth and neurodevelopmental outcome in preterm infants at high risk of chronic lung disease ( CLD ) , treated with early ( < 96 hours ) postnatal dexamethasone . DESIGN Three-year follow-up data of physical growth and neurodevelopmental outcome of preterm infants enrolled in a controlled trial to study the effectiveness of early postnatal dexamethasone administration for the prevention of CLD were review ed . The original trial included 25 treated neonates who received dexamethasone intravenously from the fourth day of life for 7 days ( 0.5 mg/kg/d for the first 3 days , 0.25 mg/kg/d the next 3 days , and 0.125 mg/kg/d on the seventh day ) , and 25 untreated neonates as controls . Forty-five surviving infants ( 22 untreated and 23 treated ) completed the 3-year follow-up . RESULTS At the end of follow-up , infants pertaining to both study groups had similar values for body weight , height , and head circumference , and a similar incidence of infants with anthropometrics data below the third percentile . Moreover , no differences were detected between the groups in regard to incidence of major cranial ultrasound abnormalities , cerebral palsy , major neurosensory impairment or IQ scores , and distribution . CONCLUSIONS Early ( < 96 hours ) postnatal dexamethasone administration at the doses employed in this study did not impair physical or neurodevelopmental outcome in preterm infants at high risk of CLD . However , the small sample size of our study was not tailored to look for long-term outcomes and our results are not in agreement with those of larger trials and systematic review s. The real risks of postnatal dexamethasone administration could be definitely assessed only when more well- design ed trials using long-term neurodevelopmental assessment as the primary outcome will be reported Objective . To assess the effect on duration of ventilator dependency of a 42-day tapering course of dexamethasone in very low birth weight neonates . Methods . Infants ( N = 118 ) were assigned r and omly , within birth weight/gender strata , to treatment with either a 42-day tapering course of dexamethasone or an equal volume of saline as placebo . Entry criteria were 1 ) birth weight < 1501 g ; 2 ) age between 15 and 25 days ; 3 ) < 10 % decrease in ventilator setting s for 24 hours and Fio 2 ≥0.3 ; 4 ) absence of patent ductus arteriosus , sepsis , major congenital malformation , congenital heart disease ; and 5 ) no evidence of maternal HIV or hepatitis B infection . The dosage schedule was 0.25 mg/kg bid for 3 days , then 0.15 mg/kg bid for 3 days , then a 10 % reduction in the dose every 3 days until a dose of 0.1 mg/kg had been given for 3 days , from which time a dose of 0.1 mg/kg qod was continued until 42 days after entry . The primary endpoint was the number of days on assisted ventilation after study entry . Secondary outcomes of interest included days on supplemental oxygen , days of hospitalization , and potential adverse effects , such as infection , gastrointestinal bleeding , left ventricular hypertrophy , and severe retinopathy of prematurity . Results . Infants in the dexamethasone- and placebo-treated groups were similar in terms of baseline attributes , including birth weight , gestational age , gender , race , and ventilator setting s at entry . Infants treated with dexamethasone were on assisted ventilation and supplemental oxygen for fewer days after study entry ( median days on ventilator , 5th and 95th percentiles , 13 [ 1–64 ] vs 25 [ 6–104 ] ; days on oxygen , 59 [ 6–247 ] vs 100 [ 11–346 ] ) . No differences were found in risk of death , infection , or severe retinopathy . In subgroup analyses , the association of dexamethasone with more rapid weaning from the ventilator was weaker among infants enrolled before the 16th day of life , infants with chest radiographs showing cystic changes and /or hyperinflation , and infants requiring an Fio 2 ≥0.7 or a peak inspiratory pressure ≥19 at study entry . Conclusions . A 42-day tapering course of dexamethasone decreases the duration of ventilator and oxygen dependency in very low birth weight infants and is not associated with an increased risk of short-term adverse effects OBJECTIVES To test the cortisol response to adrenocorticotrophic hormone ( ACTH ) in a population of very low birth weight newborns at the end of the first week of life , and to evaluate the relationship of this response to the subsequent development of bronchopulmonary dysplasia and to the total length of oxygen dependence . METHODS Appropriate for gestational age newborns < 1500 g birth weight were enrolled prospect ively . Response to ACTH stimulation was tested on days 5 , 6 , or 7 . Baseline cortisol , stimulated cortisol , and magnitude of response were compared between babies who developed bronchopulmonary dysplasia ( BPD ) , defined as oxygen dependence at 28 days , and those who recovered without BPD . RESULTS In this population , the cortisol response to ATCH increased with increasing birth weight ( P < .001 ) . Using birth weight as a cofactor , analysis of variance showed that patients who developed BPD ( n = 34 , BW 974 + /- 192 g , mean + /- S.D. ) had significantly reduced responses to ACTH at 5 to 7 days of age compared to those who recovered ( n = 25 , BW 1251 + /- 194 g ) , P = .006 . Additionally , 84 % of patients who recovered without BPD , but only 26 % of BPD patients , achieved a prospect ively defined positive cortisol response to ACTH ( > or = 9 micrograms/dL ; P < .005 ) . Supplemental oxygen was discontinued at a younger postconceptional age in babies with a positive cortisol response to ACTH ( P < .01 ) and fewer of those babies were on supplemental oxygen at 36-week postconceptional age ( P < .01 ) . CONCLUSIONS At the end of the first week of life , infants who subsequently developed BPD and prolonged oxygen dependence had significantly lower cortisol secretion in response to ACTH than infants who recovered without BPD . We speculate that these babies may be unable to secrete adequate amounts of cortisol in a setting of increased stress , leaving them vulnerable to continuing lung injury The potential induction of cardiac effects by high-dose dexamethasone therapy was evaluated prospect ively in 13 respirator-dependent infants with bronchopulmonary dysplasia by means of two-dimensional and M-mode echocardiography . The initial divided dose of dexamethasone was 500 micrograms/kg per day , tapered progressively for as long as 6 weeks . Evaluations were made before treatment and at 3 , 7 , 14 , 21 , 28 , 35 , and 42 days after the start of dexamethasone therapy . This regimen was associated with a significant ( p less than 0.01 ) increase in thickness of the interventricular septum ( 2.60 + /- 0.09 to 4.00 + /- 0.16 mm ) , diastolic left ventricular free wall ( 2.80 + /- 0.13 to 4.06 + /- 0.20 mm ) , and diastolic right ventricular free wall ( 1.55 + /- 0.08 to 2.02 + /- 0.12 mm ) . In addition , seven dexamethasone-treated infants but no control infants had systolic anterior motion of the mitral valve ( p less than 0.001 ) . These effects were transient , reached their maximal degree by the third week of treatment , and approached pretreatment conditions by the sixth week of treatment . Ejection fraction was not affected ; heart rate and mean arterial pressure were transiently increased during dexamethasone therapy . We conclude that a transient absolute myocardial hypertrophy is associated with dexamethasone therapy in infants with bronchopulmonary dysplasia . The mechanism or mechanisms through which this hypertrophy arises and the cardiopulmonary implication s are unclear BACKGROUND We studied the outcomes at school age in children who had participated in a double-blind , placebo-controlled trial of early postnatal dexamethasone therapy ( initiated within 12 hours after birth ) for the prevention of chronic lung disease of prematurity . METHODS Of the 262 children included in the initial study , 159 lived to school age . Of these children , 146 ( 72 in the dexamethasone group and 74 in the control group ) were included in our study . All the infants had had severe respiratory distress syndrome requiring mechanical ventilation shortly after birth . In the dexamethasone group , 0.25 mg of dexamethasone per kilogram of body weight was given intravenously every 12 hours for one week , and then the dose was tapered . We evaluated the children 's growth , neurologic and motor function , cognition , and school performance . RESULTS Children in the dexamethasone group were significantly shorter than the controls ( P=0.03 for boys , P=0.01 for girls , and P=0.03 for all children ) and had a significantly smaller head circumference ( P=0.04 ) . Children in the dexamethasone group had significantly poorer motor skills ( P<0.001 ) , motor coordination ( P<0.001 ) , and visual-motor integration ( P=0.02 ) . As compared with the controls , children in the dexamethasone group also had significantly lower full IQ scores ( mean [ + \n Output:\n " }, { "from": "agent", "value": "There were no significant differences in the rates of neonatal or subsequent mortality , infection , severe IVH , PVL , NEC or pulmonary haemorrhage .\nGastrointestinal bleeding and intestinal perforation were important adverse effects and the risks of hyperglycaemia , hypertension , hypertrophic cardiomyopathy and growth failure were also increased .\nIn the twelve trials that reported late outcomes , several adverse neurological effects were found at follow-up examinations including developmental delay ( not defined ) , cerebral palsy and abnormal neurological examination .\nMoreover , the rates of the combined outcomes of death or cerebral palsy , or of death or major neurosensory disability were not significantly increased .\nAUTHORS ' CONCLUSIONS The benefits of early postnatal corticosteroid treatment ( < /= 7 days ) , particularly dexamethasone , may not outweigh the known or potential adverse effects of this treatment .\nAlthough early corticosteroid treatment facilitates extubation and reduces the risk of chronic lung disease and patent ductus arteriosus , it causes short-term adverse effects including gastrointestinal bleeding , intestinal perforation , hyperglycaemia , hypertension , hypertrophic cardiomyopathy and growth failure .\nLong-term follow-up studies report an increased risk of abnormal neurological examination and cerebral palsy .\nHydrocortisone in the doses and regimens used in the reported RCTs has few beneficial or harmful effects and can not be recommended for prevention of CLD" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To look at the modification in depressive mood in postmenopausal depressed women after estrogen replacement therapy ( ERT ) . METHOD Twelve depressed patients divided into two groups of six women each were studied . One group received conjugated equine estrogens ( CEE ) 0.625 mg/day ; the other did not receive any treatment ( control group ) . Mood was assessed in all the subjects at baseline and at 6 months with Hamilton Rating Scale score and considered as depression when it was > 15 . Differences between groups were determined by Mann-Whitney U-test , and in each group between baseline and 6-month values with Wilcoxon test . RESULTS The ERT group had a statistically significant decrease in depressive mood ( 21 vs. 13 points , P < 0.03 ) , while in the control group no significant change was found . Final Hamilton scale scores were significantly lower ( P < 0.05 ) in those under ERT , when compared with those in the control group . CONCLUSION Depressive mood decreased after 6 months with CEE , so the prescription of ERT can be useful in postmenopausal women with depressive mood Abstract 5′-Methyltetrahydrofolic acid ( 5′- MTHF ) in addition to st and ard psychotropic medication significantly improved clinical recovery in depressed patients with borderline or definite folate deficiency , and significantly reduced depressive symptoms in elderly normofolatemic patients after 3 weeks of treatment . In this equivalence study the effect of 5′- MTHF on depressive symptoms and cognitive status was compared to Trazodone ( TRZ ) in normofolatemic elderly patients with mild to moderate dementia and depression . Ninety-six patients with dementia , scoring 12–23 at the Mini Mental State Examination ( MMSE ) and ≥18 at the Hamilton Depression Rating Scale ( HDRS ) after a 2-week placebo run-in , were r and omized to receive either 5′-MTHF ( 50 mg/day p.o . ) ( 47 patients ) or TRZ ( 100 mg/day p.o . ) ( 49 patients ) in a double-blind design for 8 weeks . HDRS was assessed before , after 4 weeks and at the end of treatment ; Rey ’s Verbal Memory ( RVM ) test for immediate and delayed recall was evaluated before and after treatment . After 4 weeks of treatment HDRS score was reduced from 23±5 to 20±6 in the 5′-MTHF ( p<0.05 vs baseline ) , and from 23±3 to 21±4 in the TRZ group ( p<0.05 vs baseline ) . p]A further significant decrease to 18±6 and 19±5 respectively was obtained at the end of the treatment period ( p<0.05 vs week 4 ) with 5′-MTHF and TRZ . HDRS was administered again after a 4-week , drug-free , follow-up period : no change vs the post treatment scores was observed either in the 5′-MTHF or in the TRZ group ( 18±7 and 19±5 respectively ) . RVM test for immediate recall was significantly improved ( p<0.05 ) at week 8 vs baseline in the 5′-MTHF group whereas no significant change occurred in the TRZ group . No change in delayed recall was observed after treatment in either group . Tolerability was good for both treatments . This study shows that 5′-MTHF and TRZ are equally effective in improving depressive symptoms in patients with mild to moderate dementia and suggests that pharmacological doses of 5′-MTHF may exert psychotropic effects irrespective of folate status . ( Aging Clin . Exp . Res . 1 : 63–71 , 1993 BACKGROUND It has been hypothesized that n-3 polyunsaturated fatty acids ( PUFAs ) are involved in mood regulation , but epidemiologic evidence for such a link in the general population is lacking . OBJECTIVE This study examined whether community-dwelling elderly persons with depression have a fatty acid composition that is different from that of nondepressed persons . DESIGN We screened 3884 adults aged > or = 60 y for depressive symptoms as part of the Rotterdam Study . Subjects who screened positive had a psychiatric interview to diagnose depressive disorders . All eligible subjects had their blood drawn for measurement of plasma phospholipid concentrations . We compared percentages of n-3 and n-6 PUFAs and their ratios between 264 subjects with depressive symptoms , including 106 subjects with depressive disorders , and 461 r and omly selected reference subjects . We also investigated whether atherosclerosis or the inflammatory response as measured by C-reactive protein underlies the relation between fatty acid composition and depression . RESULTS Subjects with depressive disorders had a higher ratio of n-6 to n-3 PUFAs , but differences in individual PUFAs were mostly small . However , depressed subjects with normal CRP concentrations ( < 1.5 mg/L ) had a substantially altered fatty acid composition ; percentages of n-3 PUFAs and ratios of n-6 to n-3 PUFAs were significantly lower and higher , respectively , in subjects with depressive disorders than in control subjects [ 5.2 % compared with 5.9 % ( P = 0.02 ) and 7.2 compared with 6.6 ( P = 0.01 ) , respectively ] . This relation was not due to atherosclerosis . CONCLUSIONS In community-dwelling persons , fatty acid composition is related to depression . Because this relation was not secondary to inflammation , atherosclerosis , or possible confounders , it suggests a direct effect of fatty acid composition on mood BACKGROUND Transcranial magnetic stimulation ( TMS ) , a noninvasive technique for stimulation of the brain , has recently been suggested to be effective for the treatment of major depression . We conducted a double-blind , placebo-controlled study to assess the efficacy of slow repetitive TMS ( rTMS ) in patients with major depression . METHODS Seventy patients with major depression ( 53 women , 17 men ; mean age , 58.7 years ; SD , 17.2 years ) were r and omly assigned to receive rTMS or sham rTMS in a double-blind design . Treatment was administered in 10 daily sessions during a 2-week period . Severity of depression was blindly assessed before , during , and after completion of the treatment protocol . RESULTS All patients completed the first week of treatment and 67 completed the entire protocol . Patients who received rTMS had a significantly greater improvement in depression scores compared with those who received sham treatment . At the end of 2 weeks , 17 of 35 patients in the rTMS group , but only 8 of 32 in the sham-treated group , had an improvement of greater than 50 % in their depression ratings . CONCLUSIONS This controlled study provides evidence for the short-term efficacy of slow rTMS in patients with recurrent major depression . Additional studies will be necessary to assess the efficacy of rTMS as compared with electroconvulsive therapy as well as the long-term outcome of this treatment in major depression and possibly other psychiatric disorders Rapid transcranial magnetic stimulation ( rTMS ) applied to the left dorsal lateral frontal cortex has been shown to produce antidepressant effects . Older depressed patients , however , in one study showed a lower response rate than younger patients . The current study examined treatment response in 20 depressed , treatment-refractory patients ( mean age 60.7 + /- 9.8 years ) given five sessions of rTMS at 20 Hz for 2 seconds over 20 trains at 80 % of motor threshold or identical placebo stimulation , after patients had been withdrawn from their antidepressants . There were no significant differences in Hamilton Depression Scale scores either before or after treatment at 7 days ' follow-up . There were three responders to active treatment and three to sham treatment and responders had significantly greater frontal lobe volume than nonresponders ( p = .03 ) . These findings suggest that the stimulation parameters used in this study were probably insufficient to produce treatment response and that frontal atrophy may interfere with the effectiveness of rTMS OBJECTIVE Although there is evidence for the efficacy of antidepressants and for some individual and group psychotherapy interventions for depressed older adults , a significant number of these do not respond to treatment . Authors assessed the benefits of augmenting medication with group psychotherapy . METHODS They r and omly assigned 34 ( largely chronically ) depressed individuals age 60 and older to receive 28 weeks of antidepressant medication plus clinical management , either alone ( MED ) or with the addition of dialectical behavior therapy skills-training and scheduled telephone coaching sessions ( MED+DBT ) . RESULTS Only MED+DBT showed significant decreases on mean self-rated depression scores , and both treatment groups demonstrated significant and roughly equivalent decreases on interviewer-rated depression scores . However , on interviewer-rated depression , 71 % of MED+DBT patients were in remission at post-treatment , in contrast to 47 % of MED patients . At a 6-month follow-up , 75 % of MED+DBT patients were in remission , compared with only 31 % of MED patients , a significant difference . Only patients receiving MED+DBT showed significant improvements from pre- to post-treatment on dependency and adaptive coping that are proposed to create vulnerability to depression . CONCLUSION Results from this pilot study suggest that DBT skills training and telephone coaching may offer promise to effectively augment the effects of antidepressant medication in depressed older adults Objectives : 1 ) To compare serum vitamin B12 , C and folate concentrations in a r and omly selected sample of elderly ( age 65 years or older ) male and female Hispanics and nonHispanic whites ( NHW ) and 2 ) to examine associations between serum B12 , C and folate concentrations compared to measures of cognitive and affective ( depression ) functions . Methods : Equal numbers of male and female Hispanics and NHW were r and omly sample d from the Health Care Financing Administration ( Medicare ) registrant list for Bernalillo County , New Mexico , and asked to volunteer for a paid home interview followed by a paid comprehensive interview/examination covering health and health-related issues . In addition to serum determinations of B12 , C and folate , associations were examined between these vitamins and measures of cognitive and affective functions . Results : Males and Hispanics had lower serum vitamin B12 , C and folate concentrations than females and NHW respectively . Participants taking a multivitamin supplement ( MVI ) had higher serum vitamin concentrations than those not taking MVI . There were significant associations between serum folate concentrations and measures of cognitive function , not seen with B12 or C , nor between any of the vitamins and affective function . Conclusions : Hispanics , even after adjustments for gender , age , vitamin supplementation , vitamin content of dietary foods , education and household income , had lower serum concentrations of B12 , C and folate than NHW . The most significant associations observed were those between serum folate and various measures of cognitive function , even after adjusting for presence of depression OBJECTIVE To investigate the reported association between low vitamin E levels and depressive symptoms in a population -based study . METHODS The study is based on a cohort of 3884 adults aged 60 years and over who participated in the third survey of the Rotterdam Study , were screened for depressive symptoms with the Center of Epidemiological Studies Depression Scale and from whom blood was drawn . All screen-positive subjects had a psychiatric work-up . Blood levels of vitamin E were compared between 262 cases with depressive symptoms and 459 r and omly selected reference subjects . All analyses were stratified by sex , and adjusted for age , cholesterol , cognitive score , smoking , dietary supplement use , marital status , living alone , and functional disability score . RESULTS Vitamin E levels in men with depressive symptoms were lower than in non-depressed men after adjusting for age , whereas no such difference was found in women . This association in men was substantially weakened after controlling for biological factors , and disappeared with additional adjustment for nutritional behaviour and social factors . No differences were observed when the analyses were restricted to cases with depression as defined in the Diagnostic and Statistical Manual of Mental Disorders IV . CONCLUSIONS After control for several biological and behavioural factors relating to health we found no association between low vitamin E levels and depressive symptoms or depression in the elderly Repetitive transcranial magnetic stimulation ( rTMS ) is a recent putative treatment for affective disorders . Several studies have demonstrated antidepressant effects of rTMS in younger patients ; we aim ed to assess its effect in older out patients with treatment-resistant major depression . Twenty-four out patients ( mean age=62 years , S.D.=12 ) with major depression were r and omized for sham or real stimulation and received 10 daily rTMS sessions ( 20 Hz , 2-s trains , 28-s intertrain intervals , 100 % of motor threshold ) in addition to the antidepressant medication . For sham stimulation , the coil was tilted 90 degrees . Depression severity was assessed using the Hamilton Depression Rating Scale , the Beck Depression Inventory , items from the NIMH self-rated symptom scale , and a visual analog depression scale . Mini-Mental Status Examination performance , memory , and executive and attentional functions were measured to control for cognitive side effects . Depression ratings revealed significant antidepressant effects within 2 weeks in both sham and real stimulation groups ; however , there were no between-group differences . Treatment with rTMS was safe ; adverse events were rare and not more prevalent in either group , and cognitive assessment did not show any deter \n Output:\n " }, { "from": "agent", "value": "The treatments with the best evidence of effectiveness are antidepressants , electroconvulsive therapy , cognitive behaviour therapy , psychodynamic psychotherapy , reminiscence therapy , problem-solving therapy , bibliotherapy ( for mild to moderate depression ) and exercise .\nThere is limited evidence to support the effectiveness of transcranial magnetic stimulation , dialectical behaviour therapy , interpersonal therapy , light therapy ( for people in nursing homes or hospitals ) , St John 's wort and folate in reducing depressive symptoms" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Early interventions proved to be able to improve prognosis in acute stroke patients . Prompt identification of symptoms , organised timely and efficient transportation towards appropriate facilities , become essential part of effective treatment . The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational st and ards required to grant appropriate care . We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways . We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients . We design ed a cluster r and omised controlled trial ( C- RCT ) , the most powerful study design to assess the impact of complex interventions . The study was registered in the Current Controlled Trials Register : IS RCT N41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster r and omised trial . Methods / design Two-arm cluster-r and omised trial ( C- RCT ) . 16 emergency services and 14 emergency rooms were r and omised either to arm 1 ( comprising a training module and administration of the guideline ) , or to arm 2 ( no intervention , current practice ) . Arm 1 participants ( 152 physicians , 280 nurses , 50 drivers ) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway . We estimated that around 750 patients will be met by the services in the 6 months of observation . This duration allows recruiting a sample of patients sufficient to observe a 30 % improvement in the proportion of appropriate diagnoses . Data collection will be performed using current information systems . Process outcomes will be measured at the cluster level six months after the intervention . We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to : 1 ) promptness of interventions for hyperacute ischaemic stroke ; 2 ) promptness of interventions for hyperacute haemorrhagic stroke 3 ) appropriate diagnosis . Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset < = 6 hour admitted to the stroke unit . Discussion The fields in which this trial will play are usually neglected by R and omised Controlled Trial ( RCT ) . We have chosen the Cluster-r and omised Controlled Trial ( C- RCT ) to address the issues of contamination , adherence to real practice , and community dimension of the intervention , with a complex definition of clusters and an extensive use of routine data to collect the outcomes OBJECTIVE to evaluate whether integrated care pathways improve the processes of care in stroke rehabilitation . DESIGN comparison of processes of care data collected in a r and omized controlled trial . PARTICIPANTS acute stroke patients undergoing rehabilitation r and omized to receive integrated care pathways management ( n=76 ) or conventional multidisciplinary care ( n=76 ) . MEASUREMENTS proportion of patients meeting recommended st and ards for processes of care using a vali date d stroke audit tool . RESULTS integrated care pathways methodology was associated with higher frequency of stroke specific assessment s , notably testing for inattention ( 84 % versus 60 % ; P=0.015 ) and nutritional assessment ( 74 % versus 22 % , P<0.001 ) . Documentation of provision of certain information to patients /carers ( 89 % versus 70 % ; P=0.024 ) and early discharge notification to general practitioners ( 80 % versus 45 % ; P<0.001 ) were also more common in this group . There were no significant differences in the processes of interdisciplinary co-ordination and patient management between the integrated care pathways group and the control group . CONCLUSION integrated care pathways may improve assessment and communication , even in specialist stroke setting BACKGROUND AND PURPOSE Integrated Care Pathway ( ICP ) is an organized , goal -defined , and time-managed plan that has the potential of facilitating timely interdisciplinary coordination , improving discharge planning , and reducing length of hospital stay . METHODS An ICP for stroke rehabilitation based on evidence of best practice , professional st and ards , and existing infrastructure was developed . Its effectiveness was tested in 152 stroke patients undergoing rehabilitation who were r and omized to receive ICP care coordinated by an experienced nurse ( n=76 ) or conventional multidisciplinary care ( n=76 ) . RESULTS The age , sex , premorbid functional ability , and stroke characteristics of the 2 groups were comparable . There were no differences in mortality rates ( 10 [ 13 % ] versus 6 [ 8 % ] ) , institutionalization ( 10 [ 13 % ] versus 16 [ 21 % ] ) , or length of hospital stay ( 50+/-19 versus 45+/-23 days ) between patients receiving ICP or multidisciplinary care . Patients receiving conventional multidisciplinary care improved significantly faster between 4 and 12 weeks ( median change in Barthel Activities of Daily Living Index 6 versus 2 ; P<0.01 ) and had higher Quality of Life scores at 12 weeks ( 65 versus 59 ; P=0.07 ) and 6 months ( 72 versus 63 ; P<0.005 ) . There were no significant differences in the mean duration of physiotherapy ( 42.8+/-41.2 versus 39.4+/-36.4 hours ) or occupational therapy ( 8.5+/-7.5 versus 8.0+/-7.5 hours ) received between the 2 groups . CONCLUSIONS ICP management offered no benefit over conventional multidisciplinary care on a stroke rehabilitation unit . Functional recovery was faster and Quality of Life outcomes better in patients receiving conventional multidisciplinary care OBJECTIVE To assess outcomes of using a clinical pathway for managing patients with fractured neck of femur . DESIGN Prospect i ve , pseudor and omised , controlled trial . SETTING St Vincent 's Hospital , Melbourne , Victoria ( a tertiary referral , university teaching hospital ) , 1 October 1997 to 30 November 1998 . PARTICIPANTS 111 patients ( 80 women and 31 men ; mean age , 81 years ) admitted via the emergency department with a primary diagnosis of fractured neck of femur . INTERVENTIONS Management guided by a clinical pathway ( 55 patients ) or established st and ard of care ( control group , 56 patients ) . MAIN OUTCOME MEASURES Timing of referrals and discharge planning ; total length of stay ; and complication and readmission rates within 28 days of discharge . RESULTS Patients managed according to the clinical pathway had a shorter total stay ( 6.6 versus 8.0 days ; P = 0.03 ) , even if assessment for placement by the Aged Care Assessment Service was required ( 9.5 versus 13.6 days ; P = 0.03 ) . There were no significant differences in complication and readmission rates between pathway and control patients ( complication rates , 24 % versus 36 % ; P = 0.40 ; readmission rates , 4 % versus 11 % ; P = 0.28 ) . CONCLUSION Coordinated multidisciplinary care of patients with fractured neck of femur reduces length of stay without increasing complications UNLABELLED In traditional practice patterns , physicians take care of all clinical decisions , such as diagnosis , treatment , and recovery . In the Nippon Medical School Hospital a clinical pathway for distal gastrectomy patients , recorded as a post-operative care map , was introduced in August 2000 . In January 2001 the post-operative management was analyzed and st and ardization of practice was carried out with printed order sets , such as drugs and infusion solutions . The aim of this study was to evaluate the clinical significance of the clinical pathway for gastrectomy patients by employing st and ardized postoperative management and printed order sets . PATIENTS AND METHODS From January 2001 to December 2001 , 87 patients underwent distal ( 43 ) , total ( 28 ) , proximal ( 7 ) and partial gastrectomy ( 9 ) for gastric cancer ( stage IA : 47 , IB : 9 , II : 7 , IIIA : 8 , IIIB 2 , IV : 10 ) and gastrointestinal stromal tumor ( 4 ) . These patients were r and omly assigned to either the main building or the east building of our hospital . In the main building 38 patients were looked after using traditional practice ( control group ) . In the east building 47 patients were looked after according to the clinical pathway ( path group ) and 2 patients were excluded from the path group because of neo-adjuvant chemotherapy and severe heart failure . Aspects of the patients ' outcomes , including length of stay , the first day of the diet , morbidity , and medical costs , were compared between the path group and the control group . All data were expressed as means+/-st and ard deviation . Statistical analyses were made using Student t-test , Mann-Whitney U-test , and chi(2 ) test , and the 5%level was chosen for statistical significance . RESULTS The length of the hospital stay was 27.1+/-10.0 and 40.8+/-26.1 days ( p<0.005 ) and the length of post-operative stay was 18.1+/-9.5 and 28.2+/-22.3 days ( p<0.01 ) in the path group and the control group , respectively . The post-operative day when the diet was started for the path and control groups was 6.8+/-8.9 and 8.2+/-7.2 , respectively ; however , the length of the intravenous infusion for the two groups was 11.8+/-1.1 and 16.5+/-1.2 days ( p<0.01 ) , respectively . There was no statistically significant difference in the morbidity rate between the path group ( 3/47 ) and the control group ( 5/38 ) . The total cost was 1,502,587 yen + /-41,650 in the path group and 1,932,197 yen + /-131,030 in the control ( p<0.001 ) . CONCLUSION A clinical pathway for gastrectomy patients proved useful to optimize their postoperative care , including medication management and diet education . It is suggested that the implementation of a st and ardized clinical pathway for gastrectomy patients reduced the length of the hospital stay and the medical costs OBJECTIVE Because of recent increases in health care costs , cost containment has become a important issue in medical practice . We evaluated the effect on cost and clinical outcome with the implementation of clinical care pathway for transurethral resection of the prostate ( TURP ) patients . MATERIAL S & METHODS Our series consists of 69 consecutive patients treated with TURP between June 1 , 1999 and March 31 , 2000 . The patients were divided into two groups at r and om . Thirty-two patients were treated on the clinical pathway ( pathway group ) and 37 patients were not placed on the clinical pathway program ( non-pathway group ) . Total hospital charges , average length of stay and clinical outcomes were compared in two groups . RESULTS The average of total hospital charges ( insurance points ) and average length of stay were 48,424.2 point , and 12.7 days for the pathway group , and 55.365.5 point , and 14.7 days for non-pathway group respectively . Postoperative complications and rehospitalization did not differ between two groups . DISCUSSION With the implementation of the clinical care pathway , average hospital charges and length of stay were reduced . The clinical pathway program is considered to be a good tool for health care cost management . This methodology can be applied to all patients . However , when we make the clinical pathway program , we take into account the individuality of each patients Abstract INTRODUCTION : In an era of dwindling hospital re sources and increasing medical costs , safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare re sources . Although several protocol s have been reported to reduce postoperative stay , no Level I evidence exists for their use in routine clinical practice . METHODS : Sixty-four patients undergoing laparotomy and intestinal or rectal resection were r and omly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care . Time to discharge from hospital , complication and readmission rates , pain level , quality of life , and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery . Subgroups were defined to evaluate those who derived the optimal benefit from the protocol . RESULTS : Pathway patients spent less total time in the hospital after surgery ( 5.4 vs. 7.1 days ; P = 0.02 ) and less time in the hospital during the primary admission than traditional patients . Patients younger than 70 years old had greater benefits than the overall study group ( 5 vs. 7.1 days ; P = 0.01 ) . Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway ( P = 0.01 ) . There was no difference between pathway and traditional patients for readmission or complication rates , pain score , quality of life after surgery , or overall satisfaction with the hospital stay . CONCLUSIONS : Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet . Pathway patients have a shorter hospital stay , with no adverse effect on patient satisfaction , pain scores , or complication rates . Patients younger than 70 years of age derive the optimal benefit , and increased surgeon experience improves outcome Background . Clinical pathways for asthma are tools that have the potential to improve compliance with nationally recognized management guidelines , but their effect on patient outcomes has not been \n Output:\n " }, { "from": "agent", "value": "The aim of this study was to identify the circumstances in which ICPs are effective , for whom and in what context s. Methods A systematic review of high- quality r and omised controlled trials published between 1980 and 2008 ( March ) evaluating ICP use in child and adult population s in the full range of healthcare setting s. RESULTS 1 For relatively predictable trajectories of care ICPs can be effective in supporting proactive care management and ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner .\nThis can lead to improvements in service quality and service efficiency without adverse consequences for patients .\n2 ICPs are an effective mechanism for promoting adherence to guidelines or treatment protocol s thereby reducing variation in practice .\n3 ICPs can be effective in improving documentation of treatment goals , documentation of communication with patients , carers and health professionals .\n4 ICPs can be effective in improving physician agreement about treatment options .\n5 ICPs can be effective in supporting decision-making when they incorporate a decision-aide .\n6 The evidence considered in this review indicates that ICPs may be particularly effective in changing professional behaviours in the desired direction , where there is scope for improvement or where roles are new .\n7 Even in context s in which health professionals are already experienced with a particular pathway , ICP use brings additional beneficial effects in directing professional practice in the desired direction .\n8 ICPs may be less effective in bringing about service quality and efficiency gains in variable patient trajectories .\n9 ICPs may be less effective in bringing about quality improvements in circumstances in which services are already based on best evidence and multidisciplinary working is well established .\n10 Depending on their purpose , the benefits of ICPs may be greater for certain patient subgroups than others .\n11 We do not know whether the costs of ICP development and implementation are justified by any of their reported benefits .\n12 ICPs may need supporting mechanisms to underpin their implementation and ensure their adoption in practice , particularly in circumstances in which ICP use is a significant change in organisational culture .\n13 ICP documentation can introduce scope for new kinds of error .\nConclusions ICPs are most effective in context s where patient care trajectories are predictable .\nTheir value in setting s in which recovery pathways are more variable is less clear .\nICPs are most effective in bringing about behavioural changes where there are identified deficiencies in services ; their value in context s where inter-professional working is well established is less certain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Angiogenesis plays a role in the biology of ovarian cancer . We examined the effect of bevacizumab , the vascular endothelial growth factor inhibitor , on survival in women with this disease . METHODS We r and omly assigned women with ovarian cancer to carboplatin ( area under the curve , 5 or 6 ) and paclitaxel ( 175 mg per square meter of body-surface area ) , given every 3 weeks for 6 cycles , or to this regimen plus bevacizumab ( 7.5 mg per kilogram of body weight ) , given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease . Outcome measures included progression-free survival , first analyzed per protocol and then up date d , and interim overall survival . RESULTS A total of 1528 women from 11 countries were r and omly assigned to one of the two treatment regimens . Their median age was 57 years ; 90 % had epithelial ovarian cancer , 69 % had a serous histologic type , 9 % had high-risk early-stage disease , 30 % were at high risk for progression , and 70 % had stage IIIC or IV ovarian cancer . Progression-free survival ( restricted mean ) at 36 months was 20.3 months with st and ard therapy , as compared with 21.8 months with st and ard therapy plus bevacizumab ( hazard ratio for progression or death with bevacizumab added , 0.81 ; 95 % confidence interval , 0.70 to 0.94 ; P=0.004 by the log-rank test ) . Nonproportional hazards were detected ( i.e. , the treatment effect was not consistent over time on the hazard function scale ) ( P<0.001 ) , with a maximum effect at 12 months , coinciding with the end of planned bevacizumab treatment and diminishing by 24 months . Bevacizumab was associated with more toxic effects ( most often hypertension of grade 2 or higher ) ( 18 % , vs. 2 % with chemotherapy alone ) . In the up date d analyses , progression-free survival ( restricted mean ) at 42 months was 22.4 months without bevacizumab versus 24.1 months with bevacizumab ( P=0.04 by log-rank test ) ; in patients at high risk for progression , the benefit was greater with bevacizumab than without it , with progression-free survival ( restricted mean ) at 42 months of 14.5 months with st and ard therapy alone and 18.1 months with bevacizumab added , with respective median overall survival of 28.8 and 36.6 months . CONCLUSIONS Bevacizumab improved progression-free survival in women with ovarian cancer . The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression . ( Funded by Roche and others ; ICON7 Controlled-Trials.com number , IS RCT N91273375 . ) Background : Based on the efficacy of pegylated liposomal doxorubicin ( PLD ) in relapsed ovarian cancer , we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer . Because of limited phase I and II data on PLD plus carboplatin in this setting , we conducted an interim activity analysis . Patients and Methods : Patients with stage 1c-IV epithelial ovarian cancer were r and omized to carboplatin AUC 5 plus either paclitaxel 175 mg/m2 or PLD 30 mg/m2 every 3 weeks for 6 cycles . The interim activity analysis was planned according to a single-stage phase II design with an auspicated 50 % response rate ; 50 patients eligible for response assessment were required . Response was defined according to RECIST ( Response Evaluation Criteria in Solid Tumors ) . Results : A complete response was achieved in 14 patients ( 28 % ) and a partial response in 20 ( 40 % ) , which produced an overall response rate of 68 % . The activity exceeded the minimum required for study continuation . Stable disease was reported in an additional 10 patients ( 20 % ) . Conclusions : The adopted schedule of PLD plus carboplatin demonstrates activity as a first-line treatment for advanced ovarian cancer OBJECTIVE While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer , there is a need to develop strategies that improve the effectiveness of this approach . METHODS A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin ( day 8 ; 30 - 40 mg/m(2 ) ) to a regimen of intraperitoneal cisplatin ( day 2 ; 75 mg/m(2 ) ) and intravenous ( day 1 ; 135 mg/m(2 ) ) plus intraperitoneal ( day 8 ; 60 mg/m(2 ) ) paclitaxel . Treatment was initially delivered on an every 3-week schedule , but was modified to an every 4-week program due to excessive toxicity . Patients were to receive 6 cycles of this regimen . RESULTS Of 68 patients entering this trial , 63 patients were eligible and evaluable , of whom 39 ( 62 % ) completed 6 cycles . Overall , 32 ( 51 % ) experienced at least 1 grade 4 or worse toxicity ( most commonly hematologic ) including 5 treatment-related deaths . Median progression-free survival ( PFS ) was 25 months ( 2-year PFS : 52 % ) and median overall survival 51 months , an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient population s. Seventeen patients ( 27 % of all eligible patients ) were without evidence of disease recurrence > 4 years following entry into the trial . CONCLUSION Both the overall trial outcome , and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form . The provocative PFS in a subset of individuals should encourage the development of alternative strategies design ed to optimize the delivery of regional therapy in ovarian cancer management PURPOSE This r and omized , multicenter , phase III noninferiority trial was design ed to test the efficacy and safety of the combination of pegylated liposomal doxorubicin ( PLD ) with carboplatin ( CD ) compared with st and ard carboplatin and paclitaxel ( CP ) in patients with platinum-sensitive relapsed/recurrent ovarian cancer ( ROC ) . PATIENTS AND METHODS Patients with histologically proven ovarian cancer with recurrence more than 6 months after first- or second-line platinum and taxane-based therapies were r and omly assigned by stratified blocks to CD ( carboplatin area under the curve [ AUC ] 5 plus PLD 30 mg/m(2 ) ) every 4 weeks or CP ( carboplatin AUC 5 plus paclitaxel 175 mg/m(2 ) ) every 3 weeks for at least 6 cycles . Primary end point was progression-free survival ( PFS ) ; secondary end points were toxicity , quality of life , and overall survival . RESULTS Overall 976 patients were recruited . With median follow-up of 22 months , PFS for the CD arm was statistically superior to the CP arm ( hazard ratio , 0.821 ; 95 % CI , 0.72 to 0.94 ; P = .005 ) ; median PFS was 11.3 versus 9.4 months , respectively . Although overall survival data are immature for final analysis , we report here a total of 334 deaths . Overall severe nonhematologic toxicity ( 36.8 % v 28.4 % ; P < .01 ) leading to early discontinuation ( 15 % v 6 % ; P < .001 ) occurred more frequently in the CP arm . More frequent grade 2 or greater alopecia ( 83.6 % v 7 % ) , hypersensitivity reactions ( 18.8 % v 5.6 % ) , and sensory neuropathy ( 26.9 % v 4.9 % ) were observed in the CP arm ; more h and -foot syndrome ( grade 2 to 3 , 12.0 % v 2.2 % ) , nausea ( 35.2 % v 24.2 % ) , and mucositis ( grade 2 - 3 , 13.9 % v 7 % ) in the CD arm . CONCLUSION To our knowledge , this trial is the largest in recurrent ovarian cancer and has demonstrated superiority in PFS and better therapeutic index of CD over st and ard CP Background Platinum-based combinations are the st and ard second-line treatment for platinum-sensitive ovarian cancer ( OC ) . This r and omized phase II study was undertaken in order to compare the combination of carboplatin and pegylated liposomal doxorubicin ( LD ) with carboplatin and paclitaxel ( CP ) in this setting . Methods Patients with histologically confirmed recurrent OC , at the time of or more than 6 months after platinum-based chemotherapy , were r and omized to six cycles of CP ( carboplatin AUC5 + paclitaxel 175 mg/m2 , d1q21 ) or CLD ( carboplatin AUC5 + pegylated LD 45 mg/m2 , d1q28 ) . Results A total of 189 eligible patients ( CP 96 , CLD 93 ) , with a median age of 63 years , median Performance Status ( PS ) 0 and a median platinum free interval ( PFI ) of 16.5 months , entered the study . Discontinuation due to toxicity was higher in the CP patients ( 13.5 % versus 3 % , P = 0.016 ) . The overall response rate was similar : CP 58 % versus CLD 51 % , P = 0.309 ( Complete Response ; CR 34 % versus 23 % ) and there was no statistical difference in time-to-progression ( TTP ) or overall survival ( OS ; TTP 10.8 months CP versus 11.8 CLD , P = 0.904 ; OS 29.4 months CP versus 24.7 CLD , P = 0.454 ) . No toxic deaths were recorded . Neutropenia was the most commonly seen severe toxicity ( CP 30 % versus CLD 35 % ) . More frequent in CLD were severe thrombocytopenia ( 11 % versus 2 % , P = 0.016 ) , skin toxicity and Palmar-plantar erythrodysesthesia ( PPE ) grade 1 - 2 ( 38 % versus 9 % , P < 0.001 ) , while grade 3 neurotoxicity and alopecia were higher in CP ( 7 % versus 0 % , P = 0.029 , 20 % versus 5 % , P = 0.003 ) . PS and PFI were independent prognostic factors for TTP and OS . Conclusions The combination of pegylated LD with carboplatin is effective , showing less neurotoxicity and alopecia than paclitaxel-carboplatin . It thus warrants a further phase III evaluation as an alternative treatment option for platinum-sensitive OC patients .Trial Registration Australian New Zeal and Clinical Trials Registry : Background The MITO-2 ( Multicentre Italian Trials in Ovarian cancer ) study is a r and omized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer . Due to the paucity of published phase I data on the 3-weekly experimental schedule used , an early safety analysis was planned . Methods Patients with ovarian cancer ( stage Ic-IV ) , aged < 75 years , ECOG performance status ≤ 2 , were r and omized to carboplatin AUC 5 plus paclitaxel 175 mg/m2 , every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m2 , every 3 weeks . Treatment was planned for 6 cycles . Toxicity was coded according to the NCI-CTC version 2.0 . Results The pre-planned safety analysis was performed in July 2004 . Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated . Median age was 60 years ( range 34–75 ) . Forty-three patients ( 86 % ) completed 6 cycles . Two thirds of the patients had at least one cycle delayed due to toxicity , but 63 % of the cycles were administered on time . In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity . No delay due to palmar-plantar erythrodysesthesia ( PPE ) was recorded . No toxic death was recorded . Reported hematological toxicities were : grade ( G ) 3 anemia 16 % , G3/G4 neutropenia 36 % and 10 % respectively , G3/4 thrombocytopenia 22 % and 4 % respectively . Non-haematological toxicity was infrequent : pulmonary G1 6 % , heart rhythm G1 4 % , li \n Output:\n " }, { "from": "agent", "value": "PLD/carbo is a reasonable alternative to PAC/carbo for the first-line treatment of EOC .\nAlthough three-weekly PLD/carbo may be associated with increased dose delays and discontinuations compared with the st and ard PAC/carbo regimen , it might be more acceptable to women who wish to avoid alopecia or those at high risk of neurotoxicity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs . Theory-based process evaluations conducted alongside pragmatic r and omised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change . The Ontario Printed Educational Material s ( PEM ) cluster trial was design ed to increase family physicians ’ guideline -recommended prescription of thiazide diuretics . The trial found no intervention effect . Using the theory of planned behaviour ( TPB ) , we hypothesised that changes in thiazide prescribing would be reflected in changes in intention , consistent with changes in attitude and subjective norm , with no change to their perceived behavioural control ( PBC ) , and tested this alongside the RCT . Methods We developed and sent TPB postal question naires to a r and om sub- sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs . We used analysis of covariance to test for group differences using a 2 × 3 factorial design . We content-analysed an open-ended question about perceived barriers to thiazide prescription . Using control group data , we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up . Results Four hundred twenty-six physicians completed pre- and post-intervention question naires . Baseline scores on measures of TPB constructs were high : intention mean = 5.9 out of 7 ( SD = 1.4 ) , attitude mean = 5.8 ( SD = 1.1 ) , subjective norm mean = 5.8 ( SD = 1.1 ) and PBC mean = 6.2 ( SD = 1.0 ) . The arms did not significantly differ post-intervention on any of the theory-based constructs , suggesting a possible ceiling effect . Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient clinical characteristics and potential side effects . Baseline intention ( β = 0.63 , p < 0.01 ) but not PBC ( β = 0.04 , p = 0.78 ) predicted 42.6 % of the variance in self-reported behaviour at follow-up in the control group . Conclusions Congruent with the Ontario Printed Educational Messages trial results and aligned with the TPB , we saw no impact of the intervention on any TPB constructs . The theoretical basis of this evaluation suggests possible explanations for the failure of the PEM intervention to change professional behaviour , which can directly inform the design and content of future theory-based PEM interventions to change professional behaviour . Trial registration IS RCT N , Canada IS RCT Background : Many patients with or at risk for chronic kidney disease ( CKD ) in the primary care setting are not receiving recommended care . Objective : The objective of this study is to determine whether a multifaceted , low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting . Design : A pragmatic cluster-r and omized trial , with an embedded qualitative process evaluation , will be conducted . Setting : The study population comes from the Electronic Medical Record Administrative data Linked Data base ® , which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario , Canada . The 34 primary care clinics will be r and omized to the intervention or control group . Intervention : The intervention group will receive re sources from the “ CKD toolkit ” to help improve care including practice audit and feedback , printed educational material s for physicians and patients , electronic decision support and reminders , and implementation support . Measurements : Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records . Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records . The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin . Secondary outcomes include process of care measures such as screening tests , CKD recognition , monitoring tests , angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions , blood pressure targets met , and nephrologist referral . Hierarchical analytic modeling will be performed to account for clustering . Semistructured interviews will be conducted with a r and om purpose ful sample of physicians in the intervention group to underst and why the intervention achieved the observed effects . Conclusions : If our intervention improves care , then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records . Trial Registration : Clinical Trials.gov Identifier : Introduction As an increasing number of people are living with more than 1 long-term condition , identifying effective interventions for the management of multimorbidity in primary care has become a matter of urgency . Interventions are challenging to evaluate due to intervention complexity and the need for adaptability to different context s. A process evaluation can provide extra information necessary for interpreting trial results and making decisions about whether the intervention is likely to be successful in a wider context . The 3D ( dimensions of health , drugs and depression ) study will recruit 32 UK general practice s to a cluster r and omised controlled trial to evaluate effectiveness of a patient-centred intervention . Practice s will be r and omised to intervention or usual care . Methods and analysis The aim of the process evaluation is to underst and how and why the intervention was effective or ineffective and the effect of context . As part of the intervention , quantitative data will be collected to provide implementation feedback to all intervention practice s and will contribute to evaluation of implementation fidelity , alongside case study data . Data will be collected at the beginning and end of the trial to characterise each practice and how it provides care to patients with multimorbidity . Mixed methods will be used to collect qualitative data from 4 case study practice s , purposively sample d from among intervention practice s. Qualitative data will be analysed using techniques of constant comparison to develop codes integrated within a flexible framework of themes . Quantitative and qualitative data will be integrated to describe case study sites and develop possible explanations for implementation variation . Analysis will take place prior to knowing trial outcomes . Ethics and dissemination Study approved by South West ( Frenchay ) National Health Service ( NHS ) Research Ethics Committee ( 14/SW/0011 ) . Findings will be disseminated via a final report , peer- review ed publications and practical guidance to healthcare professionals , commissioners and policymakers . Trial registration number IS RCT N06180958 Developing more effective behavioural interventions requires an underst and ing of the mechanisms of behaviour change , and methods to rigorously test their theoretical basis . The delivery and theoretical basis of an intervention protocol were assessed in ProActive , a UK trial of an intervention to increase the physical activity of those at risk of Type 2 diabetes ( N = 365 ) . In 108 intervention sessions , behaviours of facilitators were mapped to four theories that informed intervention development and behaviours of participants were mapped to 17 theoretical components of these four theories . The theory base of the intervention specified by the protocol was different than that delivered by facilitators , and that received by participants . Of the intervention techniques delivered , 25 % were associated with theory of planned behaviour ( TPB ) , 42 % with self-regulation theory ( SRT ) , 24 % with operant learning theory ( OLT ) and 9 % with relapse prevention theory ( RPT ) . The theoretical classification of participant talk showed a different pattern , with twice the proportion associated with OLT ( 48 % ) , 21 % associated with TPB , 31 % with SRT and no talk associated with RPT . This study demonstrates one approach to assessing the extent to which the theories used to guide intervention development account for any changes observed Objectives A patient safety intervention was tested in a 33-ward r and omised controlled trial . No statistically significant difference between intervention and control wards was found . We conducted a process evaluation of the trial and our aim in this paper is to underst and staff engagement across the 17 intervention wards . Design Large qualitative process evaluation of the implementation of a patient safety intervention . Setting and participants National Health Service staff based on 17 acute hospital wards located at five hospital sites in the North of Engl and . Data We concentrate on three sources here : ( 1 ) analysis of taped discussion between ward staff during action planning meetings ; ( 2 ) facilitators ’ field notes and ( 3 ) follow-up telephone interviews with staff focusing on whether action plans had been achieved . The analysis involved the use of pen portraits and adaptive theory . Findings First , there were palpable differences in the ways that the 17 ward teams engaged with the key components of the intervention . Five main engagement typologies were evident across the life course of the study : consistent , partial , increasing , decreasing and disengaged . Second , the intensity of support for the intervention at the level of the organisation does not predict the strength of engagement at the level of the individual ward team . Third , the st and ardisation of facilitative processes provided by the research team does not ensure that implementation st and ardisation of the intervention occurs by ward staff . Conclusions A dilution of the intervention occurred during the trial because wards engaged with Patient Reporting and Action for a Safe Environment ( PRASE ) in divergent ways , despite the st and ardisation of key components . Facilitative processes were not sufficiently adequate to enable intervention wards to successfully engage with PRASE components Background To reduce the spread of antibiotic resistance , there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI . This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries . The aim was to underst and how the interventions were implemented and to examine effects of the interventions on general practitioners ’ ( GPs ’ ) and patients ’ attitudes . Methods GPs were cluster r and omised to one of three intervention groups or a control group . The intervention groups received web-based training in either use of the C-reactive protein ( CRP ) test , communication skills and use of a patient booklet , or training in both . GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Question naire . Effects of the interventions on patients were assessed by a post-intervention question naire assessing patient enablement , satisfaction with the consultation , and beliefs about the risks and need for antibiotics . Results GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training , and felt that taking part had helped them to reduce prescribing . All GPs perceived reducing prescribing as more important and less risky following the intervention , and GPs in the communication groups reported increased confidence to reduce prescribing . Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful . Conclusions Our findings suggest that the interventions should be broadly acceptable to both GPs and patients , as well as feasible to roll out more widely across Europe . There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term , such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them . Given the positive effects of the booklet on patient beliefs and attitudes , it seems logical to extend the use of the patient booklet to all patients Background R and omised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness , but offer little insight into the causal mechanisms by which any change is produced . To illustrate the applicability of causal methods within r and omised trials , we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors ' predicted their test requesting behaviours and , secondly , whether the trial results were mediated by the theoretical constructs . Methods The process evaluation comprised a cross-sectional question naire survey of a r and om 50 % sample of the r and omised groups of primary care practice s in Grampian ( NHS Grampian ) , UK , who took part in a trial of the effect of enhanced feedback and brief educational reminders on test requesting behaviour . The process evaluation was based upon the Theory of Planned Behaviour and focussed on three of the test requesting behaviours that were targeted in the trial -- ferritin , follicle stimulating hormone ( FSH ) , and Helicobacter Pylori serology ( HPS ) . Results The question naire was completed by 131 primary care doctors ( 56 % ) from 42 ( 98 % ) of the sample d practice s. Behavioural intention , attitude , and subjective norm were highly correlated for all the tests . There was no evidence that perceived behavioural control was correlated with any of the other measures . Simple linear regression analysis of the rate of test requests on minimum behavioural intentions had R2 of 11.1 % , 12.5 % , and 0.1 % for ferritin , FSH , and HPS requesting , respectively . Mediational analysis showed that the trial results for ferritin and FSH were partially mediated ( between 23 % and 78 % mediation ) through intentions . The HPS trial result was not mediated through intention . Conclusions This study demonstrated that a theory-based process evaluation can provide useful information on causal mechanisms that aid not only interpretation of the trial but also inform future evaluations and intervention development Background There is a considerable evidence base for ' collaborative care ' as a method to improve quality of care for depression , but an acknowledged gap between efficacy and implementation . This study utilises the Normalisation Process Model ( NPM ) to inform the process of implementation of collaborative care in both a future full-scale trial , and the wider health economy . Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory r and omised controlled trial of a collaborative model of care for depression . Results Findings are presented as they relate to the four factors of the NPM ( interactional workability , relational integration , skill-set workability , and context ual integration ) and a number of necessary \n Output:\n " }, { "from": "agent", "value": "Although nearly two thirds of process evaluations cited a theoretical approach , only a quarter were informed by , applied , or tested a theory-despite the potential complementarity of these strategies .\nWhen theory was used , it was primarily applied .\nUsing theory more substantively in process evaluations may accelerate our underst and ing of how implementation interventions operate" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — Uric acid ( UA ) is a neuroprotective antioxidant that improves the benefits of alteplase in experimental ischemia . However , it is unknown whether endogenous UA also influences the response to thrombolysis in patients with stroke . Methods — A total of 317 consecutive patients treated with thrombolysis were included in a prospect i ve stroke registry . Demographics , laboratory data , neurological course , and infa rct ion volume were prospect ively collected . Excellent outcome was defined as achieving a modified Rankin Scale score < 2 at 90 days . Binary and ordinal logistic regression models were used to analyze modified Rankin Scale score at 90 days . Results — UA levels were significantly higher in patients with an excellent outcome than in patients with a poor outcome ( 5.82 [ 1.39 ] versus 5.42 [ 1.81 ] , P=0.029 ) . In multivariate models , increased UA levels ( OR , 1.23 ; 95 % CI , 1.03 to 1.49 ; P=0.025 ) were associated with an excellent outcome and with an increased risk of shifting to a better category across the modified Rankin Scale ( OR , 1.19 ; 95 % CI , 1.04 to 1.38 ; P=0.014 ) independently of the effect of confounders . The levels of UA and the volume of final infa rct ion were inversely correlated ( r=−0.216 , P<0.001 ) and the inverse correlation remained after adjustment for age , sex , and baseline National Institutes of Health Stroke Scale score ( t value=−2.54 , P=0.01 ) . Significantly lower UA levels were found in patients with malignant middle cerebral artery infa rct ion and parenchymal hemorrhage postthrombolysis . Conclusions — Increased UA serum levels are associated with better outcome in patients with stroke treated with reperfusion therapies . These results support the assessment of the potential neuroprotective role of the exogenous administration of UA in patients with stroke treated with thrombolysis INTRODUCTION Uric acid is an antioxidant with neuroprotective effects in experimental models of stroke . We assessed whether uric acid therapy would improve functional outcomes at 90 days in patients with acute ischaemic stroke . METHODS URICO-ICTUS was a r and omised , double-blind , placebo-controlled , phase 2b/3 trial that recruited patients with acute ischaemic stroke admitted to ten Spanish stroke centres . Patients were included if they were aged 18 years or older , had received alteplase within 4·5 h of symptom onset , and had an eligible National Institutes of Health Stroke Scale ( NIHSS ) score ( > 6 and ≤25 ) and premorbid ( assessed by anamnesis ) modified Rankin Scale ( mRS ) score ( ≤2 ) . Patients were r and omly allocated ( 1:1 ) to receive uric acid 1000 mg or placebo ( both infused intravenously in 90 min during the infusion of alteplase ) , stratified by centre and baseline stroke severity . The primary outcome was the proportion of patients with excellent outcome ( ie , an mRS score of 0 - 1 , or 2 if premorbid score was 2 ) at 90 days , analysed in the target population ( all r and omly assigned patients who had been correctly diagnosed with ischaemic stroke and had begun study medication ) . The study is registered with Clinical Trials.gov , number NCT00860366 . FINDINGS Between July 1 , 2011 , and April 30 , 2013 , we r and omly assigned 421 patients , of whom 411 ( 98 % ) were included in the target population ( 211 received uric acid and 200 received placebo ) . 83 ( 39 % ) patients who received uric acid and 66 ( 33 % ) patients who received placebo had an excellent outcome ( adjusted risk ratio 1·23 [ 95 % CI 0·96 - 1·56 ] ; p=0·099 ) . No clinical ly relevant or statistically significant differences were reported between groups with respect to death ( 28 [ 13 % ] patients who received uric acid vs 31 [ 16 % ] who received placebo ) , symptomatic intracerebral haemorrhage ( nine [ 4 % ] vs six [ 3 % ] ) , and gouty arthritis ( one [ < 1 % ] vs four [ 2 % ] ) . 516 adverse events occurred in the uric acid group and 532 in the placebo group , of which 61 ( 12 % ) and 67 ( 13 % ) , respectively , were serious adverse events ( p=0·703 ) . INTERPRETATION The addition of uric acid to thrombolytic therapy did not increase the proportion of patients who achieved excellent outcome after stroke compared with placebo , but it did not lead to any safety concerns . FUNDING Institute of Health Carlos III of the Spanish Ministry of Health and Fundación Doctor Melchor Colet Background and Purpose Experimental studies provide evidence of an association between ischemic stroke and increased oxidative stress , but data in humans are still limited and controversial . The purpose of this study was to investigate the time course of plasma antioxidant changes in ischemic stroke patients . Methods Plasma antioxidants , including water-soluble ( vitamin C and uric acid ) and lipid-soluble ( vitamins A and E ) compounds as well as antioxidant enzyme activities in plasma ( superoxide dismutase [ SOD ] and glutathione peroxidase ) and erythrocytes ( SOD ) , were measured by high-performance liquid chromatography ( antioxidant vitamins ) and by spectrophotometry ( antioxidant enzymes ) in 38 subjects ( 25 men and 13 women aged 77.2±7.9 years ) with acute ischemic stroke of recent onset ( < 24 hours ) on admission , after 6 and 24 hours , and on days 3 , 5 , and 7 . Antioxidant levels in patients on admission were compared with those of age- and sex-matched controls . Results Mean antioxidant levels and activities in patients on admission were lower than those of controls and showed a gradual increase over time . Patients with the worst early outcome ( death or functional decline ) had higher vitamin A and uric acid plasma levels and lower vitamin C levels and erythrocyte SOD activity than those who remained functionally stable . Conclusions These results suggest that the majority of antioxidants are reduced immediately after an acute ischemic stroke , possibly as a consequence of increased oxidative stress . A specific antioxidant profile is associated with a poor early outcome Rationale Oxidative stress is a major contributor to brain damage in patients with ischaemic stroke . Uric acid ( UA ) is a potent endogenous antioxidant molecule . In experimental ischaemia in rats , the exogenous administration of uric acid is neuroprotective and enhances the effect of rtPA . Moreover , in acute stroke patients receiving rtPA within 3 h of stroke onset , the intravenous administration of uric acid is safe , prevents an early decline in uric acid levels and reduces an early increase in oxidative stress markers and in active matrix metalloproteinase nine levels . Aim To determine whether the combined treatment with uric acid and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischaemic stroke patients treated within the first 4.5 h of onset of symptoms . Study design Multicentre , interventional , r and omised , double-blind and vehicle-controlled efficacy study with parallel assignment ( 1:1 ) . Estimated enrolment : 420 patients over 3 years , starting in January 2010 . Treatment arms included patients will receive a single intravenous infusion of 1 g of UA dissolved in a vehicle ( 500 ml of 0.1 % lithium carbonate and 5 % mannitol ) ( n = 210 ) or vehicle alone ( n = 210 ) . Inclusion and exclusion criteria : the study will include patients older than 18 years , treated with rtPA within the first 4.5 h of clinical onset and with a baseline National Institute of Health Stroke Scale score > 6 and < 25 and a modified Rankin Scale score ≤ 2 before the ischaemic event . Patients with renal insufficiency , gout or asymptomatic hiperuricaemia treated with allopurinol will be excluded . Study outcomes The primary outcome measure is the proportion of patients achieving an modified Rankin Scale of 0 to 1 at 3 months after treatment or two in those patients with a prior qualifying modified Rankin Scale of 2 . Secondary outcome measures include the final infa rct ion volume measured at 72 h and the proportion of patients with symptomatic intracranial haemorrhage ( ≥ 4 points of increase in the National Institute of Health Stroke Scale score ) AIMS To test the hypothesis that urate predicts cardiac death after stroke independent of conventional risk factors of atherosclerosis , creatinine and diuretic use . METHODS AND RESULTS Serum urate concentration was measured in an unselected cohort of 354 stroke survivors who were followed-up for a median of 2.8 years . Cardiac death was the primary end-point . Urate was associated with a statistically significant threefold increase in relative risk of cardiac death even after adjustment for other conventional risk factors . In the subgroup of patients who were not on diuretics , raised urate was associated with a 12-fold significant increase in relative risk of cardiac death after adjusting for renal function and other conventional risk factors . A urate concentration of greater than 0.31 mmol . l(-1 ) was 78 % sensitive at predicting cardiac death within 5 years after stroke , but was only 54 % specific . If urate exceeded 0.38 mmol . l(-1 ) , specificity of predicting cardiac death within 5 years after stroke was 88 % . CONCLUSIONS Elevated serum urate concentration may be used to stratify risk of future cardiac death after stroke . This appeared to be true even in stroke survivors who were not on diuretic therapy Contrasting observations have been made between serum urate and ischemic stroke outcomes in studies involving Caucasian population s. To assess the hypothesis that urate is associated with stroke outcomes , a prospect i ve follow-up study was performed in a cohort of Asian patients with ischemic stroke . Patients diagnosed with transient ischemic attack , first or recurrent ischemic stroke were included in this study . Serum urate , measured using high-performance liquid chromatography , was correlated with 12-month functional and vascular stroke outcomes . Poor functional outcome was defined as a modified Rankin scale exceeding 2 and vascular outcome was defined as a composite of recurrent stroke , myocardial infa rct ion or vascular death during the study period . A total of 503 patients of mean age 63 ( SD 12 ) years were included . A U-shaped relationship between urate quartiles and poor functional outcomes was demonstrated . More patients with low ( < 280microM ) and high ( > 410microM ) urate levels had poor functional outcomes ( 36 % and 27 % respectively ) , compared to those with urate levels between 340 and 410microM ( 14 % ) . No significant relationship was observed between urate and vascular outcomes . Depending on its level , serum urate may exhibit protective and deleterious effects on stroke outcomes \n Output:\n " }, { "from": "agent", "value": "This meta- analysis supports that serum uric acid level has a protective effect on neurological outcome after acute ischemic stroke .\nHigh uric acid level at the onset is a biomarker of better prognosis in patients with acute ischemic stroke" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Forty patients with rheumatoid arthritis and upper gastrointestinal lesions due to non-steroidal anti-inflammatory drugs entered a prospect i ve 6-month double-blind placebo controlled study of dietary supplementation with gamma-linolenic acid 540 mg/day . Nineteen patients received active therapy ( as evening primrose oil 6 g/day ) and 21 received placebo ( olive oil 6 g/day ) . No patient stopped non-steroidal anti-inflammatory therapy but three patients in each group reduced their dose . Other results showed a significant reduction in morning stiffness with gamma-linolenic acid at 3 months and reduction in pain and articular index at 6 months with olive oil . Whilst gamma-linolenic acid may produce mild improvement in rheumatoid arthritis , olive oil may itself have hitherto unrecognized benefits CONTEXT Research both in the United States and abroad suggests that significant numbers of people are involved with various forms of alternative medicine . However , the reasons for such use are , at present , poorly understood . OBJECTIVE To investigate possible predictors of alternative health care use . METHODS Three primary hypotheses were tested . People seek out these alternatives because ( 1 ) they are dissatisfied in some way with conventional treatment ; ( 2 ) they see alternative treatments as offering more personal autonomy and control over health care decisions ; and ( 3 ) the alternatives are seen as more compatible with the patients ' values , worldview , or beliefs regarding the nature and meaning of health and illness . Additional predictor variables explored included demographics and health status . DESIGN A written survey examining use of alternative health care , health status , values , and attitudes toward conventional medicine . Multiple logistic regression analyses were used in an effort to identify predictors of alternative health care use . SETTING AND PARTICIPANTS A total of 1035 individuals r and omly selected from a panel who had agreed to participate in mail surveys and who live throughout the United States . MAIN OUTCOME MEASURE Use of alternative medicine within the previous year . RESULTS The response rate was 69 % . The following variables emerged as predictors of alternative health care use : more education ( odds ratio [ OR ] , 1.2 ; 95 % confidence interval [ CI ] , 1.1 - 1.3 ) ; poorer health status ( OR , 1.3 ; 95 % CI , 1.1 - 1.5 ) ; a holistic orientation to health ( OR , 1.4 ; 95 % CI , 1.1 - 1.9 ) ; having had a transformational experience that changed the person 's worldview ( OR , 1 .8 ; 95 % CI , 1 .3 - 2.5 ) ; any of the following health problems : anxiety ( OR , 3.1 ; 95 % CI , 1.6 - 6.0 ) ; back problems ( OR , 2.3 ; 95 % CI , 1 .7 - 3.2 ) ; chronic pain ( OR , 2.0 ; 95 % CI , 1.1 -3.5 ) ; urinarytract problems ( OR , 2.2 ; 95 % CI , 1.3 - 3.5 ) ; and classification in a cultural group identifiable by their commitment to environmentalism , commitment to feminism , and interest in spirituality and personal growth psychology ( OR , 2.0 ; 95 % CI , 1.4 - 2.7 ) . Dissatisfaction with conventional medicine did not predict use of alternative medicine . Only 4.4 % of those surveyed reported relying primarily on alternative therapies . CONCLUSION Along with being more educated and reporting poorer health status , the majority of alternative medicine users appear to be doing so not so much as a result of being dissatisfied with conventional medicine but largely because they find these health care alternatives to be more congruent with their own values , beliefs , and philosophical orientations toward health and life BACKGROUND SKI306X , which consists of biologically active ingredients from Clematis m and sburica , Tricbosantbes kirilowii , and Prunella vulgaris , was developed and tested in pre clinical trials in Korea . Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect , and that it can delay the destruction of cartilage in rheumatoid arthritis ( RA ) . OBJECTIVE The aim of this study was to compare the pain relief and tolerability of SKI306X and celecoxib in patients with RA . METHODS This study was a 6-week , multicenter , r and omized , double-blind , double-dummy , Phase III , noninferiority clinical trial . Eligible patients were aged 18 to 80 years , had a history of RA with a disease duration of > or =3 months , and were functional American College of Rheumatology ( ACR ) class I , II , or III before entry . After a washout period of 2 weeks , patients were r and omized to SKI306X 200 mg TID or celecoxib 200 mg BID for 6 weeks . The primary end point was a change in patient assessment of pain intensity using a visual analog scale ( VAS ) . The secondary end points were a 20 % improvement in response rate as defined by the ACR ( ACR20 ) and the frequency of rescue medication use . Results after 3 and 6 weeks of treatment were compared with baseline and between treatment groups , and all patients were assessed for adverse events ( AEs ) , clinical laboratory data , and vital signs . AEs were identified based on spontaneous reports by patients during interviews conducted by the investigators and the study coordinator . RESULTS Two hundred twenty-two Korean patients from 7 medical centers were assessed and 183 were enrolled and r and omized to 1 of 2 treatment groups . Ninety-one patients ( 10 male , 81 female ; mean [ SD ] age , 52.13 [ 12.64 ] years ; mean [ SD ] duration of RA , 9.08 [ 10.23 ] years ; no. [ % ] of ACR class I , II , and III , 13 [ 14.29 ] , 44 [ 48.35 ] and 34 [ 37.36 ] patients , respectively ) received SKI306X 200 mg TID and 92 patients ( 10 male , 82 female ; mean [ SD ] age , 51.78 [ 10.94 ] years ; mean [ SD ] duration of RA , 8.78 [ 7.78 ] years ; no. [ % ] of ACR class I , II , and III , 14 [ 15.22 ] , 44 [ 47.83 ] , and 34 [ 36.96 ] patients , respectively ) received celecoxib 200 mg BID . An analysis of the change in reported pain intensity as determined by VAS ( mm ) score between baseline and week 3 ( mean [ SD ] , 13.64 [ 16.62 ] vs 14.45 [ 15.89 ] ) , and between baseline and week 6 ( 18.4 [ 20.8 ] vs 17.9 [ 19.1 ] , respectively ) suggested that SKI306X was not inferior to celecoxib . The number of patients who achieved ACR20 response rate was not significantly different between the SKI306X group and the celecoxib group at week 3 ( 16/87 [ 18.4 % ] vs 24/87 [ 27.6 % ] , respectively ) and at week 6 ( 29/87 [ 33.3 % ] vs 29/87 [ 33.3 % ] ) . The frequency of rescue medication use was not significantly different between the SKI306X group and celecoxib group at week 3 ( 54/87 [ 62.1 % ] vs 47/87 [ 54.0 % ] , respectively ) or week 6 ( 57/87 [ 65.5 % ] vs 49/87 [ 56.3 % ] ) . Drug-related AEs were reported by 27 ( 29.7 % ) patients in the SKI306X group and 22 ( 23.9 % ) patients in the celecoxib group . The most frequent drug-related AEs were epigastric pain ( 9/91 [ 9.9 % ] ) in the SKI306X group and glutamyltranferase elevation ( 4/92 [ 4.3 % ] ) in the celecoxib group . No significant between-group differences were observed in the prevalence of drug-related clinical - or laboratory-determined AEs . CONCLUSION The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA In rheumatoid arthritis ( RA ) benefit from non-steroidal anti-inflammatory drugs ( NSAIDs ) is mediated through inhibition of the cyclo-oxygenase enzyme , thereby decreasing production of the 2 series prostagl and ins ( PGs ) . The lipoxygenase enzyme is intact , however , allowing leucotriene ( LT ) production , e.g. , LTB4 ( an inflammatory mediator ) . Treatment with evening primrose oil ( EPO ) which contains gamma-linolenic acid ( GLA ) leads to production of the 1 series PGs , e.g. , PGE1 , which has less inflammatory effects . Also LT production is inhibited . Eicosapentaenoic acid ( EPA , fish oil ) treatment provides a substrate for PGs and LTs , which are also less inflammatory . In this study 16 patients with RA were given 540 mg GLA/day ( EPO ) , 15 patients 240 mg EPA and 450 mg GLA/day ( EPO/fish oil ) , and 18 patients an inert oil ( placebo ) . The aim of this study was to determine if EPO or EPO/fish oil could replace NSAID treatment in RA . The initial 12 month treatment period was followed by three months of placebo for all groups . Results at 12 months showed a significant subjective improvement for EPO and EPO/fish oil compared with placebo . In addition , by 12 months the patients receiving EPO and EPO/fish oil had significantly reduced their NSAIDs . After 3 months of placebo those receiving active treatment had relapsed . Despite the decrease in NSAIDs , measures of disease activity did not worsen . It is suggested that EPO and EPO/fish oil produce a subjective improvement and allow some patients to reduce or stop treatment with NSAIDs . There is , however , no evidence that they act as disease modifying agents The serum concentration of lipids and composition of fatty acids after overnight fasting were studied in 18 patients with rheumatoid arthritis treated for 12 weeks with either 20 ml of evening primrose oil containing 9 % of gamma-linolenic acid or olive oil . The serum concentrations of oleic acid , eicosapentaenoic acid , and apolipoprotein B decreased and those of linoleic acid , gamma-linolenic acid , dihomo-gamma-linolenic acid , and arachidonic acid increased during treatment with evening primrose oil . During olive oil treatment the serum concentration of eicosapentaenoic acid decreased and those of high density lipoprotein-cholesterol and apolipoprotein A-I increased slightly . The decrease in serum eicosapentaenoic acid and the increase in arachidonic acid concentrations induced by evening primrose oil may not be favourable effects in patients with rheumatoid arthritis in the light of the roles of these fatty acids as precursors of eicosanoids Feverfew , reputed by folklore to be effective in arthritis , has in vitro properties that could be beneficial in the control of inflammatory disease . Forty one female patients with symptomatic rheumatoid arthritis received either dried chopped feverfew ( 70 - 86 mg ) or placebo capsules once daily for six weeks . Allocation was r and om and not known by patient or observer . Variables assessed included stiffness , pain ( visual analogue scale ) , grip strength , articular index , full blood count , erythrocyte sedimentation rate , urea , creatinine , C reactive protein , complement breakdown products ( C3dg ) , rheumatoid factor titre , immunoglobulins ( IgG , IgA , IgM ) , functional capacity , and patient and observer global opinions . One patient ( placebo ) withdrew after three days and was not included in the analysis . Treatment and placebo groups ( 20 patients each ) were well matched at entry . No important differences between the clinical or laboratory variables of the groups were observed during the six week period . This study therefore shows no apparent benefit from oral feverfew in rheumatoid arthritis Eighty-two subjects with chronic arthritic pain were r and omly assigned for 2 months without cross-over to either Reumalex , a licenced over-the-counter ( OTC ) herbal medicine , or a placebo . Entry characteristics were determined by a previous survey of arthritic customers at pharmacy and healthfood shop outlets . The AIMS 2 question naire was completed at monthly intervals throughout and for 2 months prior to the trial , and a modified Ritchie Index provided clinical scores . Subjects also completed diary recordings of their use of self-prescribed analgesics and events they considered significant . There was a small but statistically significant improvement in pain symptoms , less so in sufferers from osteoarthritis . There were no other significant changes in any other measures nor in the use of other self-prescribed analgesics . There were few side-effects noted . It is concluded that Reumalex has a mild analgesic effect in chronic arthritis at a level appropriate to self-medication Dietary gammalinolenic acid ( GLA ) , a potent inhibitor of 5-lipoxygenase ( 5-LOX ) and suppressor of leukotriene B4 ( LTB4 ) , can attenuate the clinical \n Output:\n " }, { "from": "agent", "value": "For most HMPs used in the treatment of RA , the evidence of effectiveness was insufficient to either recommend or discourage their use ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : The education of patients with heart failure ( HF ) is an essential part of disease management . The perspectives of an increasing number of patients and a shortage of professionals force healthcare to explore new strategies in supporting patients to be better informed and more active . Methods : Three hundred and eighty-two patients with HF ( age 71±SD 11.2 years ) were r and omly assigned to either a telemonitoring or a usual care group . Patients received four postal question naires to assess their levels of self-reported knowledge , self-care , self-efficacy and adherence . Generalized estimating equations analysis was performed to assess the effects of telemonitoring during the 1-year follow-up . Corrections for baseline were performed if needed . Results : Baseline differences between groups were found for self-care ( p=0.001 ) and self-efficacy ( p=0.024 ) . Knowledge of patients in the telemonitoring group significantly improved with 0.9 point on a 15-points scale ( p<0.001 ) . Their self-care abilities improved with 1.5 point on a 10-item scale whereas no changes were found in patients receiving usual care ( p<0.001 ) . Self-efficacy of patients in the intervention group improved significantly after 6 months yet was not significantly different after 3 months and 1 year . For patients in the intervention group adherence improved for daily weighing ( p<0.001 ) during the whole follow-up and for fluid intake ( p=0.019 ) after 3 months and after 12 months ( p=0.086 ) . Adherence for activity recommendations improved ( p=0.023 ) after 3 months and importance of medication adherence increased after 6 ( p=0.012 ) and 12 months ( p=0.037 ) . No effects were found regarding appointments , diet , smoking and use of alcohol . Conclusions : Tailored telemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy Substantial progress has been made in the awareness , treatment , and prevention of cardiovascular disease ( CVD ) in women since the first women-specific clinical recommendations for the prevention of CVD were published by the American Heart Association ( AHA ) in 1999.1 The myth that heart disease is a “ man 's disease ” has been debunked ; the rate of public awareness of CVD as the leading cause of death among US women has increased from 30 % in 1997 to 54 % in 2009.2 The age-adjusted death rate result ing from coronary heart disease ( CHD ) in females , which accounts for about half of all CVD deaths in women , was 95.7 per 100 000 females in 2007 , a third of what it was in 1980.3,4 Approximately 50 % of this decline in CHD deaths has been attributed to reducing major risk factors and the other half to treatment of CHD including secondary preventive therapies.4 Major r and omized controlled clinical trials such as the Women 's Health Initiative have changed the practice of CVD prevention in women over the past decade.5 The investment in combating this major public health issue for women has been significant , as have the scientific and medical achievements . Despite the gains that have been made , considerable challenges remain . In 2007 , CVD still caused ≈1 death per minute among women in the United States.6 These represent 421 918 deaths , more women 's lives than were cl aim ed by cancer , chronic lower respiratory disease , Alzheimer disease , and accidents combined.6 Reversing a trend of the past 4 decades , CHD death rates in US women 35 to 54 years of age now actually appear to be increasing , likely because of the effects of the obesity epidemic.4 CVD rates in the United States are significantly higher for black females compared with their white counterparts ( 286.1/100 000 versus Background Most patients with heart failure are diagnosed and managed in primary care , however , underdiagnosis and undertreatment are common . We assessed whether implementation of a diagnostic-therapeutic strategy improves functionality , health-related quality of life , and uptake of heart failure medication in primary care . Methods / Design A selective screening study followed by a single-blind cluster r and omized trial in primary care . The study population consists of patients aged 65 years or over who presented themselves to the general practitioner in the previous 12 months with shortness of breath on exertion . Patients already known with established heart failure , confirmed by echocardiography , are excluded . Diagnostic investigations include history taking , physical examination , electrocardiography , and serum N-terminal pro B-type natriuretic peptide levels . Only participants with an abnormal electrocardiogram or an N-terminal pro B-type natriuretic peptide level exceeding the exclusionary cutpoint for non-acute onset heart failure ( > 15 pmol/L ( ≈ 125 pg/ml ) ) will undergo open-access echocardiography . The diagnosis of heart failure ( with reduced or preserved ejection fraction ) is established by an expert panel consisting of two cardiologists and a general practitioner , according to the criteria of the European Society of Cardiology guidelines . Patients with newly established heart failure are allocated to either the ' care as usual ’ group or the ' intervention ’ group . R and omization is at the level of the general practitioner . In the intervention group general practitioners receive a single half-day training in heart failure management and the use of a structured up-titration scheme . All participants fill out quality of life question naires at baseline and after six months of follow-up . A six-minute walking test will be performed in patients with heart failure . Information on medication and hospitalization rates is extracted from the electronic medical files of the general practitioners . Discussion This study will provide information on the prevalence of unrecognized heart failure in elderly with shortness of breath on exertion , and the r and omized comparison will reveal whether management based on a half-day training of general practitioners in the practical application of an up-titration scheme results in improvements in functionality , health-related quality of life , and uptake of heart failure medication in heart failure patients compared to care as usual . Trial registration Clinical Trials.gov BACKGROUND Depression is known to co-occur with coronary heart disease ( CHD ) . Depression may also inhibit the effectiveness of cardiac rehabilitation ( CR ) programs by decreasing adherence . Higher prevalence of depression in women may place them at increased risk for non-adherence . OBJECTIVE To assess the impact of a modified , stage-of-change-matched , gender-tailored CR program for reducing depressive symptoms among women with CHD . METHODS A two-group r and omized clinical trial compared depressive symptoms of women in a traditional 12-week CR program to those completing a tailored program that included motivational interviewing guided by the Transtheoretical Model of behavior change . Women in the experimental group also participated in a gender-tailored exercise protocol that excluded men . The Center for Epidemiological Studies Depression ( CES-D ) Scale was administered to 225 women at baseline , post-intervention , and at 6-month follow-up . Analysis of Variance was used to compare changes in depression scores over time . RESULTS Baseline CES-D scores were 17.3 and 16.5 for the tailored and traditional groups , respectively . Post-intervention mean scores were 11.0 and 14.3 ; 6-month follow-up scores were 13.0 and 15.2 , respectively . A significant group by time interaction was found for CES-D scores ( F(2 , 446)=4.42 , p=.013 ) . Follow-up tests revealed that the CES-D scores for the traditional group did not differ over time ( F(2 , 446)=2.00 , p=.137 ) . By contrast , the tailored group showed significantly decreased CES-D scores from baseline to post-test ( F(1 , 223)=50.34 , p<.001 ) ; despite the slight rise from post-test to 6-month follow-up , CES-D scores remained lower than baseline ( F(1 , 223)=19.25 , p<.001 ) . CONCLUSION This study demonstrated that a modified , gender-tailored CR program reduced depressive symptoms in women when compared to a traditional program . To the extent that depression hinders CR adherence , such tailored programs have potential to improve outcomes for women by maximizing adherence . Future studies should explore the mechanism by which such programs produce benefits BACKGROUND Negative emotions are linked to the onset and development of coronary heart diseases ( CHD ) , whereas positive emotions are associated with better health and lower mortality rates among patients with these diseases . The objective of this r and omised trial was to improve cardiac patients ' emotional states using a Programme to Improve Well-being ( PIW ) based exclusively on positive interventions ( those that promote intentional behaviours and thoughts to improve well-being ) . METHODS Cardiac patients ( n = 108 ) were r and omly assigned to two parallel groups . In the control group , they participated in only a Cardiac Rehabilitation Programme ( CRP group ) , whereas the intervention group also participated in the PIW ( CRP+PIW group ) . Physical functional capacity , depressive symptoms , hostility , and negative and positive affect were assessed at T1 ( baseline ) and T2 ( 8 weeks later ) . RESULTS At T2 , after controlling for functional capacity , the CRP+PIW group reported a significantly less negative affect than the CRP group . Moreover , the CRP group did not change from T1 to T2 , whereas the CRP+PIW group reported more positive emotions and fewer negative emotions and hostility at T2 than at T1 . CONCLUSIONS Positive interventions effectively improve the emotional state of cardiac patients . We suggest that specific modules should be included in the CRP to improve well-being The purpose of this pilot study was to test the initial efficacy , feasibility , and safety of a specially design ed postacute care transitional rehabilitation intervention for cardiac patients . Cardiac Transitional Rehabilitation Using Self-Management Techniques ( Cardiac TRUST ) is a family-focused intervention that includes progressive low-intensity walking and education in self-management skills to facilitate recovery following a cardiac event . Using a r and omized two-group design , exercise self-efficacy , steps walked , and participation in an outpatient cardiac rehabilitation ( CR ) program were compared in a sample of 38 older adults ( 17 Cardiac TRUST , 21 usual care ) . At discharge from postacute care , the intervention group trended toward higher levels of self-efficacy for exercise outcomes than the usual care group . During the 6 weeks following discharge , the intervention group had greater attendance in outpatient CR and a trend toward more steps walked during the first week . The feasibility of the intervention was better for the home health care participants than for those in the skilled nursing facility . The provision of CR during postacute care has the potential to bridge the gap in transitional services from hospitalization to outpatient CR for these patients at high risk for future cardiac events . Further evidence of the efficacy of Cardiac TRUST is warranted Aim : To investigate whether phase II cardiac rehabilitation ( CR ) conducted by a community model of shared care CR ( SC-CR ) including health care centres and general practice was feasible and provided acceptable results and to compare SC-CR to hospital-based CR ( H-CR ) in a r and omised controlled trial . Methods : Patients were r and omised to H-CR or SC-CR after admission for acute coronary syndrome . In SC-CR , the general practitioner took over the responsibility of the remaining rehabilitation , pharmacological treatment and risk factor management after the initial visit to the hospital outpatient clinic . The Municipal Health Care Centres provided courses on smoking cessation , nutrition , and exercise training and contributed to disease education and psychosocial support . The main endpoint was adherence to the CR programme and compliance with lifestyle modifications . Results : In total , 1364 patients were screened , 327 ( 24 % ) were eligible , and 212 ( 65 % ) accepted participation . Phase II CR was completed by 192 ( 91 % ) of the participants . Full adherence to the CR programme was seen in 53 % in SC-CR versus 54 % in H-CR ( relative risk ( RR ) : 0.98 , 95 % confidence interval : 0.73–1.32 ) . In H-CR , patients had higher rates of adherence to dietary advice and health education . In SC-CR , 12 % of patients did not attend the risk factor evaluation and clinical assessment with their general practitioner . No difference in risk factor improvement was found . Exercise training was declined by 25 % in both groups . Conclusion : Adherence to phase II CR was high in both groups . SC-CR did not improve adherence and efficacy , but had comparable effects on medication and risk factors . Thus , SC-CR was safe and effective Background Angina affects more than 50 million people worldwide . Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population . An Internet-based version could offer a feasible alternative . Objective Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina . Methods We conducted a r and omized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group . Intervention group participants were offered a 6-week Web-based rehabilitation program ( “ ActivateYourHeart ” ) . The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) . The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking . Performance against goals was review ed throughout the program and goals were then reset/modified . Participants completed an online exercise \n Output:\n " }, { "from": "agent", "value": "In terms of equity , trialists tested interventions design ed to improve utilisation among women and older patients .\nEvidence is insufficient for quantitative assessment of whether women-tailored programmes were associated with increased utilisation , and studies that assess motivating women are needed .\nFor older participants , again while quantitative assessment could not be undertaken , peer navigation may improve enrolment .\nEffects on enrolment were larger in studies targeting healthcare providers , training nurses , or allied healthcare providers to intervene face-to-face ; effects on adherence were larger in studies that tested remote interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: INTRODUCTION Lack of r and omized controlled trials ( RCTs ) that compare pure laparoscopic radical prostatectomy ( LRP ) with robot-assisted laparoscopic radical prostatectomy ( RALRP ) is an important gap of the literature related to the surgical treatment of the clinical ly localized prostate cancer ( PCa ) . AIM To provide the first prospect i ve r and omized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinical ly localized PCa . METHODS Between 2007 and 2008 , 128 consecutive male patients were r and omized in two groups and treated by a single experienced surgeon with traditional LRP ( Group I-64 patients ) or RALRP ( Group II-64 patients ) in all cases with intent of bilateral intrafascial nerve sparing . MAIN OUTCOME MEASURES Primary end point was to compare the 12 months erectile function ( EF ) outcomes . Complication rates , continence outcomes , and oncological results were also compared . The sample size of our study was able , with an adequate power ( 1-beta > 0.90 ) , to recognize as significant large differences ( above 0.30 ) between incidence proportions of considered outcomes . RESULTS No statistically significant differences were observed for operating time , estimated blood loss , transfusion rate , complications , rates of positive surgical margins , rates of biochemical recurrence , continence , and time to continence . However , the 12-month evaluation of capability for intercourse ( with or without phosphodiesterase type 5 inhibitors ) showed a clear and significant advantage of RALRP ( 32 % vs. 77 % , P < 0.0001 ) . Time to capability for intercourse was significantly shorter for RALRP . Rates of return to baseline International Index of Erectile Function ( IIEF-6 ) EF domain score question naires ( questions 1 - 5 and 15 ) ( 25 % vs. 58 % ) and to IIEF-6 > 17 ( 38 % vs. 63 % ) were also significantly higher for RALRP ( P = 0.0002 and P = 0.008 , respectively ) . CONCLUSIONS Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure . Larger RCTs are needed to confirm if a new gold-st and ard treatment in the field of RP has risen Abstract Background Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique . Prior trials have demonstrated improved cosmesis with the single-incision technique . Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach . This is the first prospect i ve , r and omized , controlled study comparing robotic single-site cholecystectomy ( RSSC ) and multiport laparoscopic cholecystectomy ( MPLC ) in terms of cosmesis and patient satisfaction . Methods Patients with symptomatic benign gallbladder disease were r and omized to RSSC or MPLC . Data included perioperative variables such as operative time , conversion and complications and cosmesis satisfaction , body image perception , quality of life using vali date d question naires , at postoperative visits of 2 , 6 weeks and 3 months . Results One hundred thirty-six patients were r and omized to RSSC ( N = 83 ) and MPLC ( N = 53 ) at 8 institutions . Both cohorts were dominated by higher enrollment of females ( RSSC = 78 % , MPLC = 92 % ) . The RSSC and MPLC cohorts were otherwise statistically matched . Operative time was longer for RSSC ( 61 min vs. 44 min , P < 0.0001 ) . There were no differences in complication rates . RSSC demonstrated a significant superiority in cosmesis satisfaction and body image perception ( P value < 0.05 at every follow-up ) . There was no statistically significant difference in patient-reported quality of life . Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in cosmesis satisfaction and body image perception with no difference seen in overall quality of life . Conclusions Results from this trial show that RSSC is associated with improved cosmesis satisfaction and body image perception without a difference in observed complication rate . The uncompromised safety and the improved cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site approach . Clinical Trials.gov identifier NCT01932216 Open radical prostatectomy ( ORP ) is the reference st and ard for the surgical management of localized prostate cancer . With wider availability of minimally invasive radical prostatectomy techniques , there is a debate regarding the st and ard treatment of the management of localized prostate cancer . Therefore , we review ed the current status of laparoscopic radical prostatectomy ( LRP ) and robotic-assisted laparoscopic radical prostatectomy ( RALRP ) as compared with ORP . Because no prospect i ve , r and omized trials comparing the different techniques have been performed , outcomes must be assessed from published series by centers that focus on ORP , LRP , and RALRP . Aside from reducing the amount of blood loss , current data suggest that the most significant outcomes ( cure , continence , and potency ) are no better with LRP or RALRP than with conventional ORP . Therefore , in experienced h and s , ORP remains the gold st and ard procedure . However , there is a trend toward consistently better outcomes following RALRP in comparison with LRP . In the end , individual patient outcomes can be maximized by choosing the best modality based on the patient 's comorbid medical conditions , cancer characteristics , and surgeon experience . Future studies are needed to further investigate long-term cancer control as well as functional outcomes for RALRP series Background : Traditional laparoscopic anterior rectal resection ( TLAR ) has recently been used for rectal cancer , offering good functional results compared with open anterior resection and result ing in a better postoperative early outcome . However , laparoscopic rectal resection can be technically dem and ing , especially when a total mesorectal excision is required . The aim of this study was to verify whether robot-assisted anterior rectal resection ( RLAR ) could overcome limitations of the laparoscopic approach . Methods : Sixty-six patients with rectal cancer were enrolled in the study . Twenty-nine patients underwent RLAR and 37 TLAR . Groups were matched for age , BMI , sex ratio , ASA status , and TNM stage , and were followed up for a mean time of 12 months . Results : Robot-assisted laparoscopic rectal resection results in shorter operative time when a total mesorectal excision is performed ( 165.9±10 vs 210±37 minutes ; P<0.05 ) . The conversion rate is significantly lower for RLAR ( P<0.05 ) . Postoperative morbidity was comparable between groups . Overall survival and disease-free survival were comparable between groups , even though a trend towards better disease-free survival in the RLAR group was observed . Conclusion : RLAR is a safe and feasible procedure that facilitates laparoscopic total mesorectal excision . R and omized clinical trials and longer follow-ups are needed to evaluate a possible influence of RLAR on patient survival OBJECTIVE : To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse . METHODS : This single-center , blinded r and omized trial included participants with stage 2–4 posthysterectomy vaginal prolapse . Participants were r and omized to laparoscopic or robotic sacrocolpopexy . The primary outcome was total operative time from incision to closure . Secondary outcomes were postoperative pain , functional activity , bowel and bladder symptoms , quality of life , anatomic vaginal support , and cost from a health care system perspective . RESULTS : A total of 78 patients enrolled and were r and omized ( laparoscopic n=38 ; robotic n=40 ) . Total operative time was significantly longer in the robotic group compared with the laparoscopic group ( + 67-minute difference ; 95 % confidence interval [ CI ] 43–89 ; P<.001 ) . Anesthesia time , total time in the operating room , total sacrocolpopexy time , and total suturing time were all significantly longer in the robotic group . Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs ( median , 20 compared with 11 days , P<.005 ) . The robotic group incurred greater cost than the laparoscopic group ( mean difference + $ 1,936 ; 95 % CI $ 417–$3,454 ; P=.008 ) . Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups . CONCLUSION : Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00551993 . LEVEL OF EVIDENCE : OBJECTIVE The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy . STUDY DESIGN This study was a blinded , prospect i ve r and omized controlled trial conducted at 2 institutions . Subjects consisted of women who planned laparoscopic hysterectomy for benign indications . Preoperative r and omization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size ( > or ≤12 weeks ) . Vali date d question naires , activity assessment scales , and visual analogue scales were administered at baseline and during follow-up evaluation . RESULTS Sixty-two women gave consent and were enrolled and r and omly assigned ; 53 women underwent surgery ( laparoscopic , 27 women ; robot-assisted , 26 women ) . There were no demographic differences between groups . Compared with laparoscopic hysterectomy , total case time ( skin incision to skin closure ) was significantly longer in the robot-assisted group ( mean difference , + 77 minutes ; 95 % confidence interval , 33 - 121 ; P < .001 ] as was total operating room time ( entry into operating room to exit ; mean difference , + 72 minutes ; 95 % confidence interval , 14 - 130 ; P = .016 ) . Mean docking time was 6 ± 4 minutes . There were no significant differences between groups in estimated blood loss , pre- and postoperative hematocrit change , and length of stay . There were very few complications , with no difference in individual complication types or total complications between groups . Postoperative pain and return to daily activities were no different between groups . CONCLUSION Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy , robotic-assisted hysterectomy requires a significantly longer operative time Background A new technical tool was developed and introduced into the therapeutic field of videoscopic surgery — robotic telemanipulation surgery . The aim of this study is to investigate in a prospect i ve r and omized trial the feasibility of the Nissen procedure using the da Vinci and to evaluate the benefits and the costs of this new technique compared with the conventional laparoscopic approach . Material s and methods Twenty patients with gastro-esophageal reflux disease ( GERD ) were r and omized into laparoscopic Nissen versus robot-assisted Nissen fundoplication . All the patients signed an informed consent document . The time data of the procedure , the efficacy of the instruments , the intra-operative incidents , postoperative morbidity , and cost minimization are presented . Results Nine patients were assigned to the robot , and 11 to the laparoscopic procedure . Both groups were similar in age , male/female ratio , and body mass index . The robot procedure time was significantly longer . The hospital stay and the alimentation day were similar . The number of postoperative complaints was similar after the 1st , 6th , and 12th postoperative months . However , on the 3rd postoperative month , the number of complaints was significantly higher in the robot group . The robot procedure was more expensive with regard to the instrumentation and reusable material , the nursing costs , the investment costs , and the maintenance costs . Conclusions No clear advantage of using robotics in the Nissen procedure was observed . The procedure seems to be feasible and safe . The technique is limited because of unadapted instruments . The disadvantages are the high costs and prolonged operative time Background Robotic technology represents the latest development in minimally-invasive surgery . Nevertheless , robotic-assisted surgery seems to have specific disadvantages such as an increase in costs and prolongation of operative time . A general clinical implementation of the technique would only be justified if a relevant improvement in outcome could be demonstrated . This is also true for laparoscopic fundoplication . The present study was design ed to compare robotic-assisted ( RALF ) and conventional laparoscopic fundoplication ( CLF ) with the focus on operative time , costs und perioperative outcome . Methods Forty patients with gastro-esophageal reflux disease were r and omized to either RALF by use of the daVinci ® Surgical System or CLF . Nissen fundoplication was the st and ard anti-reflux procedure . Peri-operative data such as length of operative procedure , intra- and postoperative complications , length of hospital stay , overall costs and symptomatic short-term outcome were \n Output:\n " }, { "from": "agent", "value": "FINDINGS CLS shows significant advantages in total operative time , net operative time , total complication rate , and operative cost ( p < 0.05 in all cases ) , whereas the estimated blood loss was less in RLS ( p < 0.05 ) .\nDespite higher operative cost , RLS does not result in statistically better treatment outcomes , with the exception of lower estimated blood loss .\nOperative time and total complication rate are significantly more favorable with CLS" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Fourteen intubated infants recovering from neonatal respiratory disease had arterial blood gases and lung mechanics measured in the supine position and in two variants of the prone position . Prone positioning result ed in significant increases in mean ( + /- SEM ) arterial oxygen tension ( Pa(o2 70.4 + /- 2.5 to 81.1 + /- 4.4 mm Hg ) , dynamic lung compliance ( 1.7 + /- 0.24 to 2.55 + /- 0.37 ml/cm H2O ) , and tidal volume ( 8.6 + /- 1.0 to 10.5 + /- 1.2 ml ) when all prone values were compared to supine values . Prone positioning with the abdomen protruding freely , when compared to all supine values , was associated with significantly increased dynamic lung compliance and tidal volume . Values for prone-abdomen free were not significantly different from values for prone-abdomen restricted . This suggests that there are clinical benefits from prone positioning in neonates recovering from respiratory disease Our objective was to determine the effect of posture on respiratory function and drive in prematurely born infants immediately prior to discharge . Twenty infants ( 6 oxygen-dependent ) , median gestational age 29 weeks ( range , 25 - 32 ) , were studied at a median postconceptional age ( PCA ) of 36 weeks ( range , 33 - 39 ) . On 2 successive days , infants were studied both supine and prone ; each posture was maintained for 3 hr . The order on each day in which postures were studied was r and omized between infants . At the end of each 3-hr period , tidal volume ( Vt ) , inspiratory ( Ti ) and expiratory ( Te ) time , respiratory rate , and minute ventilation were measured . In addition , respiratory drive was assessed by measuring the pressure generated in the first 100 msec of an imposed airway occlusion ( P(0.1 ) ) , and respiratory muscle strength was assessed by recording the maximum inspiratory pressure ( Pimax ) generated against an occlusion which was maintained for at least five breaths . Overall , tidal volume was higher ( P < 0.05 ) , but respiratory rate ( P < 0.05 ) , P(0.1 ) ( P < 0.05 ) , and Pimax ( P < 0.05 ) were lower in the prone compared to the supine position . There were no significant differences in Ti or Te between the two postures . In oxygen-dependent infants only , minute volume was higher in the prone position ( P < 0.05 ) . In conclusion , posture-related differences in respiratory function are present in prematurely born infants studied prior to neonatal unit discharge Studies of the effect of body position during and after bolus feeding upon gastric emptying or gastric residual have not had consistent results . We tested the hypotheses that right lateral decubitus leads to less gastric residual than left lateral decubitus and that the prone position leads to less gastric residual than the supine position . A prospect i ve r and omized clinical trial with triple crossover of healthy growing , appropriate for gestational age preterm infants . Each infant was successively studied while fed in the four different positions . Gastric residuals were measured at 1 and 3 hours after initiation of feeding and returned . Thirty-one patients were studied . At 1 hour , right lateral decubitus led to less significant residuals than the left lateral decubitus and the prone position led to less residual than the left lateral decubitus . The amount of gastric residuals 1 hour after a meal appears to be in the following decreasing order : left , supine , prone , right UNLABELLED BACKGROUND . The preterm infant is subject to the force of gravity : when its body lies pressed against the mattress on which it is placed . AIMS The purpose of this study was to investigate short-term effects of varied post-natal lying positions in order to prevent neuromuscular and postural abnormalities . METHODS 60 low risk preterm infants of 31 - 36 weeks gestational age were enrolled for this r and omised clinical trial . Initially each child underwent neurological and psychomotor assessment s which included tonus and reflex protocol s as well as behavioral , sensory motor and postural examinations . The lying positions of the treated group were varied ( back , prone , and side ) using a specially design ed moldable mattress that maintained the functional position of the infant 's body . The control group was placed on their stomachs , ( the st and ard lying position used in 1994 ) with a st and ard orthopaedic bolster support under their hips . All infants underwent a second round of examinations upon discharge to assess any changes in neurological and psychomotor outcomes . RESULTS The sensory-motor skills examinations showed significant abnormalities in the control group : ( 1 ) dominance of the extensor muscles due to muscle shortening , ( 2 ) hyper abduction and flexion of the arms , and ( 3 ) global neuromuscular rigidity . Psychomotor and neurological exams of the control and treatment groups showed delayed developmental muscular acquisitions for infants in the control group . CONCLUSION Regular changes in posture , while retaining correct functional positions , allowed maintenance of normal neuromuscular and osteo-articular function and permitted the development of spontaneous and functional motor activity in low-risk perterm infants OBJECTIVE : The purpose of this study was to determine the effects of prone and supine positioning on the cardiorespiratory stability of preterm infants with apnea and bradycardia . METHODS : A total of 22 preterm infants with symptomatic apnea and bradycardia ( gestational age of 26.9 ± 1.8 weeks and birth weight of 865 ± 235 gm ) were monitored for 24 hours ( in four sequential 6-hour blocks ) for apnea , bradycardia , and oxygen desaturation in alternating positions ( prone or supine ) following r and omization . Postconceptional age at the time of study was 31.9 ± 3.0 weeks . Respiratory rate , heart rate , and transcutaneous oxygen saturation were continuously monitored . All episodes of apnea ( ≥10 seconds ) , bradycardia ( < 100 beats per minute ) , and oxygen desaturation ( < 90 % ) were recorded on an event monitor . Episodes of apnea , bradycardia , and oxygen desaturation were defined as clinical ly significant if the following criteria were met : apnea , ≥15 seconds ; bradycardia , < 90 beats per minute ; and oxygen desaturation , < 80 % . All other recorded episodes were considered mild . The episodes were analyzed for statistical significance using the paired t-test . RESULTS : No significant differences ( p > 0.05 ) in the incidence of clinical ly significant apnea , bradycardia , or desaturation between supine and prone positions were seen in these preterm infants . CONCLUSION : Our results suggest that the cardiorespiratory stability of preterm infants is not significantly compromised by supine positioning Objective The purpose of this study was to examine the influence of prone and supine position in preterm infants during acute pain of blood collection . Setting Level III Neonatal Intensive Care Unit ( NICU ) . Study Design Thirty-eight preterm infants ( birthweight 1339 [ 590–2525 ] g , GA 29 [ 25– 32 ] wks ) were in 2 groups depending on their position in the isolette prior to and during heel lance at 32 weeks post-conceptional age . The study design was a comparison between groups ( Prone , Supine ) during 2 events ( Baseline , Heel lance ) . Outcome MeasurePain measures were multidimensional , including behavioral ( sleep – wake state and facial activity ) and physiological ( heart rate ) responses measured continuously prior to ( Baseline ) and during blood collection ( Lance ) . Results Both groups of infants displayed statistically significant shifts in sleep – wake state to greater arousal , and increased facial activity and heart rate , from Baseline to Lance . Prone position was associated with significantly more deep sleep during Baseline , compared with Supine position , but there were no differences in sleep-wake state during Lance . Minor increased facial activity was shown in some time segments of Baseline for infants in Supine compared with Prone , but did not differ overall between positions . Prone and Supine position did not affect heart rate significantly during Baseline or Lance events . Conclusions Prone position promotes deep sleep in preterm neonates at 32 weeks post-conceptional age when they are undisturbed . However , placement in prone position is not a sufficient environmental comfort intervention for painful invasive procedures such as heel lance for blood sampling in the NICU . Neonates require other environmental supports to promote coping with this stressful event Background . As a result of the American Academy of Pediatrics ' recommendation that healthy infants be placed on their side or back for sleep , the percentage of infants sleeping prone has decreased dramatically . With the increase in supine sleeping , pediatricians have question ed if there are differences in the rate of acquisition of early motor milestones between prone and supine sleeping infants . Methods . To examine this question , we performed a prospect i ve , practice -based study of healthy term infants . Infants were recruited before the age of 2 months . Parents were asked to record infant sleep position and awake time spent prone until 6 months of age . A developmental log was used to track milestones from birth until the infant was walking . Age of acquisition of eight motor milestones was determined , and the mean ages of milestone attainment of prone and supine sleepers were compared . Results . Three hundred fifty-one infants completed the study . Prone sleepers acquired motor milestones at an earlier age than supine sleepers . There was a significant difference in the age of attainment of rolling prone to supine , tripod sitting , creeping , crawling , and pulling to st and . There was no significant difference in age when infants walked . Conclusions . The pattern of early motor development is affected by sleep position . Prone sleepers attain several motor milestones earlier than supine sleepers . However , all infants achieved all milestones within the accepted normal age range . Pediatricians can use this information to reassure parents . This difference in milestone attainment is not a reason to ab and on the American Academy of Pediatrics ' sleep position recommendations OBJECTIVE We investigated whether nursing in the head elevated tilt position ( HETP ) , compared with the horizontal position , has any effect on the incidence of bradycardic and hypoxemic episodes in preterm infants . METHODS Twelve spontaneously breathing preterm infants with idiopathic recurrent apnea were studied in a r and omized controlled crossover trial . Nine infants were treated with aminophylline . Each spent a total of 24 hours in the horizontal prone position and a total of 24 hours in HETP ( prone , 15 degrees ) . The position was changed in r and om order every 6 hours . Thoracic impedance , heart rate , and arterial oxygen saturation were recorded continuously . The frequency of isolated hypoxemia ( arterial saturation < 80 % ) , of isolated bradycardia ( heart rate < 90 beats per minute ) , and of mixed events was analyzed and compared without knowledge of the allocated position . RESULTS In total , there were significantly fewer bradycardic and /or hypoxemic episodes ( 28.2 % ) in HETP compared with the horizontal position ( mean difference , 13.35 episodes/24 hours ; 95 % confidence interval [ CI ] : 5.9- 20.8 ) . The decrease was largest for isolated hypoxemic episodes ( 48.5 % ; mean difference , 11.74 episodes/24 hours ; 95 % CI : 6.1 - 17.4 ) . Isolated bradycardic episodes ( mean difference , 2.27 episodes/24 hours ; 95 % CI : -0.78 - 5.31 ) and mixed events were not decreased significantly in HETP . CONCLUSIONS Nursing in a moderately tilted position ( 15 degrees ) reduces hypoxemic events in preterm infants . This intervention is easy to apply , quickly reversible , and can be combined with drugs such as aminophylline OBJECTIVE . Prematurely born compared with term born infants are at increased risk of sudden infant death syndrome , particularly if slept prone . The purpose of this work was to test the hypothesis that preterm infants with or without bronchopulmonary dysplasia being prepared for neonatal unit discharge would sleep longer and have less arousals and more central apneas in the prone position . METHODS . This was a prospect i ve observational study in a tertiary NICU . Twenty-four infants ( 14 with bronchopulmonary dysplasia ) with a median gestational age of 27 weeks were studied at a median postconceptional age of 37 weeks . Video polysomnographic recordings of 2-channel electroencephalogram , 2-channel electro-oculogram , nasal airflow , chest and abdominal wall movements , limb movements , electrocardiogram , and oxygen saturation were made in the supine and prone positions , each position maintained for 3 hours . The duration of sleep , sleep efficiency ( total sleep time/total recording time ) , and number and type of apneas , arousals , and awakenings were recorded . RESULTS . Overall , in the prone position , infants slept longer , had greater sleep efficiency ( 89.5 % vs 72.5 % ) , and had more central apneas ( median : 5.6 vs 2.2 ) , but fewer obstructive apneas ( 0.5 vs 0.9 ) . The infants had more awakenings ( 9.7 vs 3.5 ) and arousals per hour ( 13.6 vs 9.0 ) when supine . There were similar findings in the \n Output:\n " }, { "from": "agent", "value": "The results of this review support the prone position in preterm infants for improvement of arterial oxygen saturation , improved lung and chest wall synchrony of respiratory improvements , decreased incidence of apnea in infants with a clinical history of apnea , promoted sleep , and decreased gastroesophageal reflux .\nHowever , the prone position increased postural abnormalities , orthopaedic abnormalities of the feet , and delayed developmental musculature .\nThe combined use of a postural support roll and a postural nappy while very preterm infants are nursed , improved hip and shoulder posture up to term postmenstrual age .\nThe change in body position from horizontal to head-up tilt in very immature and unstable infants may affect the cerebral homodynamic .\nThe management of position per se may not be sufficient for assisting preterm neonates to cope with the painful procedure .\nFurthermore , preterm infants are susceptible to oxygen desaturation in car seats and carrying slings .\nProne positioning was shown to have many advantages for prematurely born infants .\nBut the longer , deep sleep period and fewer awakenings associated with a prone position would support higher vulnerability for preterm infants to sudden infant death syndrome ( SIDS ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Although dietary restriction often results in initial weight loss , the majority of obese dieters fail to maintain their reduced weight . Diet-induced weight loss results in compensatory increase of hunger , craving and decreased ghrelin suppression that encourage weight regain . A high protein and carbohydrate breakfast may overcome these compensatory changes and prevent obesity relapse . METHODS In this study 193 obese ( BMI 32.2±1.0kg/m(2 ) ) , sedentary non diabetic adult men and women ( 47±7years ) were r and omized to a low carbohydrate breakfast ( LCb ) or an isocaloric diet with high carbohydrate and protein breakfast ( HCPb ) . Anthropometric measures were assessed every 4weeks . Fasting glucose , insulin , ghrelin , lipids , craving scores and breakfast meal challenge assessing hunger , satiety , insulin and ghrelin responses , were performed at baseline , after a Diet Intervention Period ( Week 16 ) and after a Follow-up Period ( Week 32 ) . RESULTS At Week 16 , groups exhibited similar weight loss : 15.1±1.9 kg in LCb group vs. 13.5±2.3 kg in HCPb group , p=0.11 . From Week 16 to Week 32 , LCb group regained 11.6±2.6 kg , while the HCPb group lost additional 6.9±1.7 kg . Ghrelin levels were reduced after breakfast by 45.2 % and 29.5 % following the HCPb and LCb , respectively . Satiety was significantly improved and hunger and craving scores significantly reduced in the HCPb group vs. the LCb group . CONCLUSION A high carbohydrate and protein breakfast may prevent weight regain by reducing diet-induced compensatory changes in hunger , cravings and ghrelin suppression . To achieve long-term weight loss , meal timing and macronutrient composition must counteract these compensatory mechanisms which encourage weight regain after weight loss BACKGROUND Energy or calorie restriction ( CR ) has consistently been shown to produce weight loss and have beneficial health effects in numerous species , including primates and humans . Most individuals , however , are unable to sustain weight losses induced through reductions in energy intake , potentially due to increased hunger levels . The effects that prolonged CR has on subjective aspects of appetite have not been well studied . Thus , the present study tested the effect of 6 months of caloric restriction on appetite in healthy , overweight men and women . METHODS Forty-eight overweight men and women with a body mass index ( BMI ; kg m(-2 ) ) between 25 - 29.9 took part in a 6-month study and were r and omised into one of four groups : healthy diet ( control ) ; 25 % CR ; 12.5 % CR plus exercise ( 12.5 % increased energy expenditure ; CR + EX ) ; low-calorie diet [ LCD ; 3724 kJ day(-1 ) ( 890 kcal day(-1 ) ) until 15 % of initial body weight was lost , then maintenance ] . Appetite markers ( i.e. hunger , fullness , desire to eat , etc . ) were assessed weekly during a fasting state . RESULTS Body weight was significantly reduced in all three energy-restricted groups ( CR = -10.4 + /- 0.9 % ; CR + EX = -10.0 + /- 0.8 % ; and LCD = -13.9 + /-0.7 % ) , indicating that participants were adherent to their energy restriction regimen , whereas the healthy diet control group remained weight stable ( control = -1.0 + /- 1.1 % ) . Despite these significant weight losses , appetite ratings of participants in the three energy-restricted groups at month 6 were similar to the weight stable control group . CONCLUSIONS CR regimens with low fat diets producing significant weight losses have similar effects on appetite markers over a 6-month time period compared to a weight stable control group Few well-controlled trials have evaluated the effects that macronutrient composition has on changes in food cravings during weight loss treatment . The present study , which was part of the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial , investigated whether the fat and protein content of four different diets affected changes in specific food cravings in overweight and obese adults . A sample of 811 adults were recruited across two clinical sites , and each participant was r and omly assigned to one of four macronutrient prescriptions : 1 ) low fat ( 20 % of energy ) , average protein ( 15 % of energy ) ; 2 ) moderate fat ( 40 % ) , average protein ( 15 % ) ; 3 ) low fat ( 20 % ) , high protein ( 25 % ) ; 4 ) moderate fat ( 40 % ) , high protein ( 25 % ) . With few exceptions , the type of diet that participants were assigned did not differentially affect changes in specific food cravings . Participants assigned to the high-fat diets , however , had reduced cravings for carbohydrates at month 12 ( p<0.05 ) and fruits and vegetables at month 24 . Also , participants assigned to high-protein diets had increased cravings for sweets at month 6 and month 12 ( ps<0.05 ) . Participants in all four dietary conditions reported significant reductions in food cravings for specific types of foods ( i.e. , high fat foods , fast food fats , sweets , and carbohydrates/starches ; all ps<0.05 ) . Cravings for fruits and vegetables , however , were increased at month 24 ( p<0.05 ) . Calorically restricted diets ( regardless of their macronutrient composition ) yielded significant reductions in cravings for fats , sweets , and starches whereas cravings for fruits and vegetables were increased Behavioral studies have suggested that food cues have stronger motivating effects in obese than in normal-weight individuals , which may be a risk factor underlying obesity . Previous cross-sectional neuroimaging studies have suggested that this difference is mediated by increased reactivity to food cues in parts of the reward system in obese individuals . To date , however , only a few prospect i ve neuroimaging studies have been conducted to examine whether individual differences in brain activation elicited by food cues can predict differences in weight change . We used functional magnetic resonance imaging ( fMRI ) to investigate activation in reward-system as well as other brain regions in response to viewing high-calorie food vs. control pictures in 25 obese individuals before and after a 12-week psychosocial weight-loss treatment and at 9-mo follow-up . In those obese individuals who were least successful in losing weight during the treatment , we found greater pre-treatment activation to high-calorie food vs. control pictures in brain regions implicated in reward-system processes , such as the nucleus accumbens , anterior cingulate , and insula . We found similar correlations with weight loss in brain regions implicated by other studies in vision and attention , such as superior occipital cortex , inferior and superior parietal lobule , and prefrontal cortex . Furthermore , less successful weight maintenance at 9-mo follow-up was predicted by greater post-treatment activation in such brain regions as insula , ventral tegmental area , putamen , and fusiform gyrus . In summary , we found that greater activation in brain regions mediating motivational and attentional salience of food cues in obese individuals at the start of a weight-loss program was predictive of less success in the program and that such activation following the program predicted poorer weight control over a 9-mo follow-up period Objective Very-low-calorie diets have been shown to produce dramatic improvements in glycemic control in obese subjects with non-insulin-dependent ( type II ) diabetes . There have been no studies of the psychological responses of diabetic subjects to these diets . Research Design and Methods This study examined changes in hunger , depression , and anxiety in 33 obese type II diabetic subjects who were r and omly assigned to behavior modification programs that used either a balanced diet of 4185–6277 J∕day ( 1000–1500 cal∕day ) throughout or included an 8-wk period of a very-low-calorie diet ( 1674 J∕day or 400 cal∕day of lean meat , fish , or fowl ) . Subjects completed the Beck Depression Inventory , the Spielberger State Anxiety Question naire , and self-report measures of hunger frequently throughout the 20-wk program . Results Both groups experienced significant improvements in depressive symptomatology , anxiety , and lessening of hunger during the course of the program , with no significant differences observed between the balanced diet and the very-low-calorie diet groups . Conclusions Very-low-calorie diets , used in the context of a behavioral weight-control program , result in reductions in hunger and improvements in mood state comparable to those observed on more moderate weight-loss regimens Objective Few studies have examined brain changes in response to effective weight loss ; none have compared different methods of weight-loss intervention . We compared functional brain changes associated with a behavioral weight loss intervention to those associated with bariatric surgery . Methods 15 obese participants were recruited prior to adjustable gastric b and ing surgery and 16 obese participants were recruited prior to a behavioral diet intervention . Groups were matched for demographics and amount of weight lost . fMRI scans ( visual food motivation paradigm while hungry and following a meal ) were conducted before , and 12 weeks after surgery/behavioral intervention . Results When compared to bariatric patients in the pre-meal analyses , behavioral dieters showed increased activation to food images in right medial PFC and left precuneus following weight loss . When compared to behavioral dieters , bariatric patients showed increased activation in in bilateral temporal cortex following the weight loss . Conclusions Behavioral dieters showed increased responses to food cues in medial PFC – a region associated with valuation and processing of self-referent information – when compared to bariatric patients . Bariatric patients showed increased responses to food cues in brain regions associated with higher level perception — when compared to behavioral dieters . The method of weight loss determines unique changes in brain function This study compared reports of appetite and symptoms in 28 obese subjects r and omly assigned to either a 500 calorie protein-sparing modified fast ( PSMF ) or a 1200-kcal balanced diet . During the first comparison month , subjects consuming the PSMF lost significantly more weight and reported significantly less hunger than did subjects consuming the 1200 kcal diet . Similar results were obtained for the second month , but differences in hunger were not statistically significant . There were no significant differences between conditions in subjects ' ratings of their preoccupation with eating or in their ratings of the acceptability or disruptiveness of their diets . PSMF subjects reported significantly greater problems with cold intolerance , constipation , dizziness , dry skin , and fatigue . These symptoms remitted completely , however , when PSMF subjects consumed a 1200-kcal balanced diet . There were no significant differences between conditions in subjects ' reports of psychological functioning . Results are discussed in terms of the need for further research to identify the characteristics of PSMF which confer anorexia The importance of hunger state for the acquisition and expression of chocolate craving was investigated . Seventeen chocolate cravers and 12 non-cravers were supplied with chocolate and instructed to eat some twice a day for 14 days . Within each group , subjects were allocated to one of two conditions , hungry- or full-trained . Hungry-trained subjects were asked to eat the chocolate exclusively at least 2 h after last eating ; full-trained subjects were asked only to eat the chocolate 15 - 30 min after eating a meal . A diary was kept to encourage and allow assessment of compliance . At the start and end of the 2 weeks , subjects rated their craving for and anticipated intake of chocolate prior to eating it ; then , on initial tasting , pleasantness of the taste was rated . All subjects made these ratings on one day when hungry and on another when full , as defined above . For cravers and non-cravers who ate chocolate exclusively when hungry , chocolate craving increased post-training , but , at least for cravers , only when ratings were made while hungry . For full-trained subjects , chocolate craving decreased post-training , but this decrease did not depend on whether subjects were currently hungry or full . A similar pattern of results was found for anticipated intake and pleasantness of taste , except that pleasantness did not increase in hungry-trained subjects . The results are interpreted with reference to learned control of appetite and in particular to recent findings on incentive learning processes . Craving for chocolate or other foods may be an expression of a strong appetite elicited by hunger that has been acquired by repeated experience of eating the craved food when hungry We examined the association of food cravings with weight loss and eating behaviors in a lifestyle intervention for weight loss in worksites . This research was part of a r and omized controlled trial of a 6-month weight loss intervention versus a wait-listed control in 4 Massachusetts worksites . The intervention emphasized reducing energy intake by adherence to portion-controlled menu suggestions , and assessment s were obtained in 95 participants at baseline and 6 months including non-fasting body weight , food cravings ( Craving Inventory and Food Craving Question naire for state and trait ) and the eating behavior constructs restraint , disinhibition and hunger ( Eating Inventory ) . There were statistically significant reductions in all craving variables in the intervention group compared to the controls . Within the intervention group , changes in craving-trait were significantly associated with weight loss after controlling for baseline weight , age , gender and worksite . However , in a multivariate model with craving-trait and eating behaviors ( restraint , disinhibition and hunger ) , hunger was the only significant predictor of weight change . In contrast to some previous reports of increased food cravings with \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Calorie restriction is associated with reduced food cravings supporting a de-conditioning model of craving reductions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The federal menu labeling law will require chain restaurants to post caloric information on menus , but the impact of labeling is uncertain . PURPOSE The goal of the current study was to examine the effect of menu labeling on calories purchased , and secondarily , to assess self-reported awareness and use of labels . DESIGN Single-community pre-post-post cross-sectional study . Data were collected in 2008 - 2010 and analyzed in 2011 - 2012 . SETTING / PARTICIPANTS 50 sites from 10 chain restaurants in King County , Washington , selected through stratified , two-stage cluster r and om sampling . A total of 7325 customers participated . Eligibility criteria were : being an English speaker , aged ≥ 14 years , and having an itemized receipt . The study population was 59 % male , 76 % white non-Hispanic , and 53 % aged<40 years . INTERVENTION A regulation requiring chain restaurants to post calorie information on menus or menu boards was implemented . MAIN OUTCOME MEASURES Mean number of calories purchased . RESULTS No significant changes occurred between baseline and 4 - 6 months postregulation . Mean calories per purchase decreased from 908.5 to 870.4 at 18 months post-implementation ( 38 kcal , 95 % CI=-76.9 , 0.8 , p=0.06 ) in food chains and from 154.3 to 132.1 ( 22 kcal , 95 % CI=-35.8 , -8.5 , p=0.002 ) in coffee chains . Calories decreased in taco and coffee chains , but not in burger and s and wich establishments . They decreased more among women than men in coffee chains . Awareness of labels increased from 18.8 % to 61.7 % in food chains and from 4.4 % to 30.0 % in coffee chains ( both p<0.001 ) . Among customers seeing calorie information , the proportion using it ( about one third ) did not change substantially over time . After implementation , food chain customers using information purchased on average fewer calories compared to those seeing but not using ( difference=143.2 kcal , p<0.001 ) and those not seeing ( difference=135.5 kcal , p<0.001 ) such information . CONCLUSIONS Mean calories per purchase decreased 18 months after implementation of menu labeling in some restaurant chains and among women but not men Objective Obesity is a pressing public health problem without proven population -wide solutions . Research ers sought to determine whether a city-m and ated policy requiring calorie labeling at fast food restaurants was associated with consumer awareness of labels , calories purchased and fast food restaurant visits . Design and Methods Difference-in-differences design , with data collected from consumers outside fast food restaurants and via a r and om digit dial telephone survey , before ( December 2009 ) and after ( June 2010 ) labeling in Philadelphia ( which implemented m and atory labeling ) and Baltimore ( matched comparison city ) . Measures included : self-reported use of calorie information , calories purchased determined via fast food receipts , and self-reported weekly fast-food visits . Results The consumer sample was predominantly Black ( 71 % ) , and high school educated ( 62 % ) . Post-labeling , 38 % of Philadelphia consumers noticed the calorie labels for a 33 percentage point ( p<.001 ) increase relative to Baltimore . Calories purchased and number of fast food visits did not change in either city over time . Conclusions While some consumer reports noticing and using calorie information , no population level changes were noted in calories purchased or fast food visits . Other controlled studies are needed to examine the longer term impact of labeling as it becomes national law Background Girl Scouting may offer a viable channel for health promotion and obesity prevention programs . This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was design ed to foster healthful troop meeting environments and increase obesity prevention behaviors at home . Methods Seven Girl Scout troops were r and omized to intervention ( n = 3 , with 34 girls ) or st and ard-care control ( n = 4 , with 42 girls ) conditions . Girls ranged in age from 9 to 13 years ( mean 10.5 years ) . Intervention troop leaders were trained to implement policies promoting physical activity ( PA ) and healthful eating opportunities at troop meetings , and to implement a curriculum promoting obesity-prevention behaviors at home . The primary outcome variable was child body mass index ( BMI ) z-score . Secondary outcomes included accelerometer-assessed PA levels in troop meetings , direct observations of snack offerings , time spent in physically active meeting content , and leader encouragement of PA and healthful eating . Results The intervention was delivered with good fidelity , and intervention troops provided greater opportunities for healthful eating and PA ( x2 = 210.8 , p < .001 ) , relative to control troops . In troop meetings , intervention troop leaders promoted PA ( x2 = 23.46 , p < .001 ) and healthful eating ( x2 = 18.14 , p < .001 ) more frequently , and discouraged healthful eating and PA less frequently ( x2 = 9.63 , p = .002 ) compared to control troop leaders . Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition , including the primary outcome of child BMI z-score ( F1 , 5 = 0.42 , p = .544 ) , parent BMI ( F1 , 5 = 1.58 , p = .264 ) , and related behavioral variables . The notable exception was for objective ly assessed troop PA , wherein girls in intervention troops accumulated significantly less sedentary ( x2 = 6.3 , p = .011 ) , significantly more moderate ( x2 = 8.2 , p = .004 ) , and more moderate-to-vigorous physical activity , ( x2 = 18.4 , p < .001 ) , than girls in control troops . Conclusions Implementing a health promotion curriculum and supporting policies to provide more healthful environments in Girl Scout troop meetings appears feasible on a broader scale . Additional work is needed to bridge health promotion from such setting s to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes . Trial registration number : AIMS To analyse the effect on systematic review s in diabetes interventions of including only trials that are indexed in medline , and to assess the impact of adding trials from other data bases and the grey literature . METHODS All systematic review s of diabetes interventions which included a meta- analysis of r and omized controlled trials , and were published since 1996 , were selected . The impact on the meta- analysis of including only those trials indexed in medline , and the effect of then adding trials from other sources , was assessed . Where possible this was measured quantitatively , by redoing the meta- analysis , otherwise a qualitative estimate was made . RESULTS Forty-four systematic review s met our inclusion criteria . There were 120 articles reporting trial data which were not indexed in medline . These came from 52 % of the review s. In 34 % of the review s , basing a meta- analysis on a search of only medline would miss trials that could affect the result . Sources of non- medline data which had the biggest effect on the meta-analyses were journal articles from central and embase ( mainly in Diabetes , Nutrition and Metabolism ) and unpublished data ( mainly from industry ) . The exceptions were journal articles on herbal medicine , mostly indexed in Chinese language data bases . CONCLUSIONS A search of only the medline data base is insufficient for systematic review s of diabetes , because in about 34 % of review s the missed trials could affect the results of the meta- analysis . It is recommended that central ( on the Cochrane Library ) also be search ed . Scanning meeting abstract s , and seeking unpublished data are also recommended if the intervention has only recently been introduced OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials OBJECTIVE The objective was to test the hypothesis that a community-based environmental change intervention could prevent weight gain in young children ( 7.6 + /- 1.0 years ) . RESEARCH METHODS AND PROCEDURES A non-r and omized controlled trial was conducted in three culturally diverse urban cities in Massachusetts . Somerville was the intervention community ; two socio-demographically-matched cities were control communities . Children ( n = 1178 ) in grade s 1 to 3 attending public elementary schools participated in an intervention design ed to bring the energy equation into balance by increasing physical activity options and availability of healthful foods within the before- , during- , after-school , home , and community environments . Many groups and individuals within the community ( including children , parents , teachers , school food service providers , city departments , policy makers , healthcare providers , before- and after-school programs , restaurants , and the media ) were engaged in the intervention . The main outcome measure was change in BMI z-score . RESULTS At baseline , 44 % ( n = 385 ) , 36 % ( n = 561 ) , and 43 % ( n = 232 ) of children were above the 85th percentile for BMI z-score in the intervention and the two control communities , respectively . In the intervention community , BMI z-score decreased by -0.1005 ( p = 0.001 , 95 % confidence interval , -0.1151 to -0.0859 ) compared with children in the control communities after controlling for baseline covariates . DISCUSSION A community-based environmental change intervention decreased BMI z-score in children at high risk for obesity . These results are significant given the obesigenic environmental backdrop against which the intervention occurred . This model demonstrates promise for communities throughout the country confronted with escalating childhood obesity rates Research ers often analyze r and omized trials and other comparative studies by separate analysis of changes from baseline in each parallel group . This may be the only analysis presented or it may be in addition to the direct comparison of allocated groups . We illustrate this by reference to 3 recently published nutritional trials . We show why this method of analysis may be highly misleading and may produce type I errors far greater than the 5 % that we expect . We recommend direct comparison of means between groups with the use of baseline as a covariate if required Objectives Universal interventions may widen or narrow inequalities if disproportionately effective among higher or lower socio-economic groups . The present paper examines impacts of the Primary School Free Breakfast Initiative in Wales on inequalities in children 's dietary behaviours and cognitive functioning . Design Cluster-r and omised controlled trial . Responses were linked to free school meal ( FSM ) entitlement via the Secure Anonymised Information Linkage data bank . Impacts on inequalities were evaluated using weighted school-level regression models with interaction terms for intervention × whole-school percentage FSM entitlement and intervention × aggregated individual FSM entitlement . Individual-level regression models included interaction terms for intervention × individual FSM entitlement . Setting Fifty-five intervention and fifty-six wait-list control primary schools . Subjects Approximately 4500 children completed measures of dietary behaviours and cognitive tests at baseline and 12-month follow-up . Results School-level models indicated that children in intervention schools ate a greater number of healthy items for breakfast than children in control schools ( b = 0·25 ; 95 % CI 0·07 , 0·44 ) , with larger increases observed in more deprived schools ( interaction term b = 1·76 ; 95 % CI 0·36 , 3·16 ) . An interaction between intervention and household-level deprivation was not significant . Despite no main effects on breakfast skipping , a significant interaction was observed , indicating declines in breakfast skipping in more deprived schools ( interaction term b = −0·07 ; 95 % CI −0·15 , −0·00 ) and households ( OR = 0·67 ; 95 % CI 0·46 , 0·98 ) . No significant influence on ine quality was observed for the remaining outcomes . Conclusions Universal breakfast provision may reduce socio-economic inequalities in consumption of healthy breakfast items and breakfast skipping . There was no evidence of intervention-generated inequalities in any outcomes Background Ident \n Output:\n " }, { "from": "agent", "value": "The majority of associations remained neutral when stratified by participant population , implementation level and socioeconomic position measures and by anthropometric and behavioural outcomes .\nFiscal measures had consistently neutral or positive impacts on inequities ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background / Aims : The ideal end point of treatment for chronic hepatitis B virus ( HBV ) infection is sustained off-therapy hepatitis B surface antigen ( HBsAg ) loss with or even without seroconversion to anti-HBs . We investigated the role of adding PEGylated interferon ( PEG IFN ) to ongoing tenofovir treatment in chronic HBV patients for achieving HBsAg clearance . Patients and Methods : In this r and omized controlled trial , chronic HBV patients who have been receiving tenofovir for > 6 months with HBV viral load < 2000 IU/ml were r and omized into two groups . One group ( add-on therapy ) was given subcutaneous PEG IFN 180 mcg weekly for 12 months in addition to tenofovir . Patients in the other group received only tenofovir 300 mg orally on a daily basis . Patients in both groups were followed up for a total of two years , and patients in both groups were given tenofovir 300 mg daily indefinitely until they developed HBsAg clearance . Results : Twenty-three patients were allocated to the PEG IFN and tenofovir ( add-on therapy ) group , and another 25 patients were recruited to the tenofovir monotherapy group . Before r and omization , patients had received tenofovir for 1135 mean days ( range203 to 1542 days ) . One patient ( 4.3 % ) in add-on therapy lost HBsAg and seroconverted . Within two years , mean HBsAg decreased significantly with add-on therapy ( from 4753 IU/ml to 2402 ; P= 0.03 ) ; and it decreased from 5957 IU/ml to 4198 ; P= 0.09 in tenofovir monotherapy group . More patients in the add-on group developed serious side effects , with treatment discontinuation , and dose reductions ( P = 0.3 ) . Conclusion : PEG IFN and tenofovir add-on therapy was successful in achieving HBsAg clearance and seroconversion in 4.3 % of the patients . Add-on therapy patients had a significant decrease in HBsAg levels in two years ; and no significant decrease in HBsAg levels with the tenofovir monotherapy . With no significant HBsAg clearance , the utility of this combination regimen is question able BACKGROUND AND AIMS Results of studies using lamivudine and interferon combination in the treatment of chronic hepatitis B are not consistent or conclusive . This study aim ed to evaluate the efficacy of interferon plus lamivudine use versus single lamivudine in anti-HBe-positive chronic hepatitis B. METHODS Eighty patients were treated with either lamivudine or lamivudine plus simultaneously started interferon . Patients were assigned in groups according to r and om allocation rule . Lamivudine was given 150 mg/day for 96 weeks in each group ; interferon was administered 10 MU three times a week for 24 weeks in the combination therapy group . RESULTS Alanine aminotransferase ( ALT ) normalization was achieved earlier in patients treated with lamivudine alone . At the end of treatment , there was no difference between the groups with respect to HBV DNA negativity , ALT normalization and breakthrough rate . Histological improvement was remarkable in each group , but fibrosis score and necro-inflammatory activity were much lower in lamivudine-treated patients . CONCLUSIONS Addition of interferon to the lamivudine regimen does not increase the effectiveness of the treatment . Considering the side effects of interferon treatment , this combination seems not to be convenient for anti-HBe-positive chronic hepatitis AIM To compare the efficacy of a combination of a-interferon ( IFN-a ) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B ( CHB ) . METHODS Sixty-eight treatment-naove patients with HBeAg-positive CHB were r and omized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily ( Group 1 ) , or IFN-a2a alone in the same dosage ( Group 2 ) , for 12 months . Serum ALT , HBeAg , anti-HBe and HBV DNA were tested at the end of treatment and 6 months later . Complete response was defined as normal ALT , negative HBeAg and negative HBV DNA , six months after stopping treatment . RESULTS Of the 68 patients , 64 completed the study . In Group 1 ( n=31 ) , mean ( SD ) ALT levels decreased from 124 ( 59 ) IU/L to 39 ( 18 ) IU/L at 12 months ; corresponding values in Group 2 ( n=33 ) were 128 ( 57 ) and 56 ( 11 ) IU/L ( p < 0.05 ) . Absence of HBV DNA at the end of treatment was more common in Group 1 ( 28/31 ) than in Group 2 ( 22/33 ; p < 0.022 ) . The number of patients with seroconversion to anti-HBe ( 4/31 [ 13 % ] vs. 4/33 [ 12 % ] , respectively ; p>0.05 ) , as also those with complete response ( 4/31 [ 13 % ] and 4/33 [ 12 % ] , respectively ; p>0.05 ) six months after completion of treatment was similar in Group 1 and Group 2 . CONCLUSION Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA ; however , it did not have a better sustained response rate than IFN-a alone BACKGROUND Pegylated interferon (PEG-IFN)-alpha monotherapy is the current st and ard of care for short-term antiviral treatment of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B ( CHB ) . We aim ed to assess the safety and efficacy of PEG-IFN-alpha plus adefovir dipivoxil ( ADV ) versus PEG-IFN-alpha monotherapy for compensated HBeAg-negative CHB . METHODS A multicentre r and omized controlled trial was performed in eight outpatient hepatology/infectious disease clinics in central Italy . A total of 60 patients ( 67 % male and median age 48 years ) with biopsy-proven HBeAg-negative compensated CHB ( mean alanine aminotranferase [ ALT ] levels 3.3 + /-3x the upper normal limit and serum hepatitis B virus [ HBV ] DNA 5.8 + /-0.9 log(10 ) IU/ml ) were r and omized at baseline to receive PEG-IFN-alpha2a 180 microg/week plus ADV 10 mg/day or PEG-IFN-alpha2a monotherapy for 48 weeks . Post-treatment follow-up was for 24 additional weeks . The primary end point was sustained HBV DNA suppression defined as serum HBV DNA<2,000 IU/ml after 24 weeks of post-treatment follow-up . The secondary end point was ALT normalization at the end of follow-up . RESULTS At week 48 , HBV DNA was undetectable in 20/30 ( 67 % ) in the combination group versus 11/30 ( 37 % ) patients in the monotherapy group ( P=0.02 ) . ALT normalization was achieved in 17/30 ( 57 % ) versus 10/30 ( 30 % ) patients , respectively ( P=0.03 ) . At week 72 , sustained virological response was achieved in 7/30 ( 23.3 % ) in the combination group versus 6/30 ( 20 % ) patients in the monotherapy group ( P=0.75 ) ; 5 ( 16 % ) patients in each group dropped out because of adverse events or non-compliance . CONCLUSIONS In HBeAg-negative CHB , combination PEG-IFN-alpha2a plus ADV for 48 weeks is safe and result ed in greater on-treatment efficacy than PEG-IFN-alpha2a monotherapy . No difference in sustained virological and biochemical response rates were observed between the two treatment regimens Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background : The aims of this study were to compare the efficacy and safety of the addition of adefovir dipivoxil ( ADV ) ( started at different time points ) to pegylated interferon alpha-2a ( PEG-INF-&agr;2a ) and PEG-INF-&agr;2a monotherapy . This prospect i ve , r and omized study sought to evaluate the safety and efficacy of the combination of PEG-INF-&agr;2a and ADV at different time points.120 patients were r and omized into groups that received PEG-INF-&agr;2a as monotherapy ( group A ) or in combination with ADV started at week 0 ( group B ) , 12 ( group C ) , or 24 ( group D ) . All patients were followed for 48 weeks . Efficacy and safety analyses were performed . Methods : Patients in group a received 135 & mgr;g of PEG-INF-&agr;2a by subcutaneous injection once weekly for 48 weeks . Patients in the ADV add-on group received 135 & mgr;g of PEG-INF-&agr;2a subcutaneously once weekly and received 10 mg of ADV administered once daily for 48 weeks . HBV DNA , HBsAg , HBeAg , and hepatitis B e antibody levels were determined . Responses were determined at week 12 ( ADV add-on ) , the end of treatment for PEG-INF-&agr;2a ( 48weeks ) and ADV ( EOT ) and at the end of 96 weeks of follow-up ( EOF ) . Results : The rate of HBV DNA loss were higher in the combination groups than group A at the week 12 , week 48 , the EOT and EOF ( P < 0.05 ) . The rates of HBeAg seroconversion and HBsAg loss were similar among the treatment groups ( P>0.05 ) . The alanineaminotransferase ( ALT ) normalization rate was higher in the combination group than group A only at the EOT ( P = 0.007 ) . By the EOF , the patients with ADV added at week 12 achieved higher rates of HBV DNA loss ( 71.9 % ) , HBeAg seroconversion ( 50.0 % ) , HBsAg loss ( 15.6 % ) , and ALT normalization ( 78.1 % ) . Conclusions : PEG-INF-&agr;2a plus ADV combination therapy is safe and superior to PEG-INF-&agr;2amonotherapyfor decreasing serum HBV DNA and normalizing the ALT level but has no significant impact on the rate of HBeAg seroconversion and HBsAg loss . Adding ADV at week 12 may be an optimal combination strategy BACKGROUND & AIMS Durable post-treatment response is uncommon in chronic hepatitis B ( CHB ) patients on nucleos(t)ide analogue therapy . Response , response predictors and safety were assessed in patients who switched from long-term entecavir ( ETV ) to peginterferon alfa-2a . METHODS Hepatitis B e antigen (HBeAg)-positive CHB patients who had received ETV for 9 - 36 months , with HBeAg < 100 PEIU/ml and HBV DNA ⩽1000 copies/ml , were r and omised 1:1 to receive peginterferon alfa-2a 180 μg/week or ETV 0.5mg/day for 48 weeks . The primary endpoint was HBeAg seroconversion at week 48 ( Clinical Trials.gov : NCT00940485 ) . RESULTS 200 patients were r and omised ; 197 received ⩾1 study drug dose . Five patients who were anti-HBe-positive at baseline were excluded from the modified intention-to-treat population ( peginterferon alfa-2a , n = 94 ; ETV , n = 98 ) . Patients who switched to peginterferon alfa-2a achieved higher week 48 HBeAg seroconversion rates vs. those who continued ETV ( 14.9 % vs. 6.1 % ; p = 0.0467 ) . Only patients receiving peginterferon alfa-2a achieved HBsAg loss ( 8.5 % ) . Among peginterferon alfa-2a-treated patients with HBeAg loss and HBsAg < 1500 IU/ml at r and omisation , 33.3 % and 22.2 % achieved HBeAg seroconversion and HBsAg loss , respectively . Early on-treatment HBsAg decline predicted response at week 48 ; highest rates were observed in patients with week 12 HBsAg < 200 IU/ml ( HBeAg seroconversion , 66.7 % ; HBsAg loss , 77.8 % ) . Alanine aminotransferase elevations were not associated with viral rebound ( n = 38 ) . Peginterferon alfa-2a was well-tolerated . CONCLUSIONS For patients who achieve viro \n Output:\n " }, { "from": "agent", "value": "In conclusion , IFN monotherapy/combination had a small but significant increase in HBsAg loss over NA , associated with st and ard dose of IFN and ≥48weeks of therapy , although this effect faded over time" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Clopidogrel is used with aspirin as a st and ard combined treatment in patients with acute coronary syndrome . A proton pump inhibitor ( PPI ) is often administered to patients receiving antiplatelet therapy . However , PPI use with clopidogrel was recently shown to result in increased risk of major cardiovascular events when compared to clopidogrel use alone . Therefore , the aim of the present study was to evaluate the effects of omeprazole , a PPI , on the antiplatelet effect of clopidogrel . We divided 20 healthy volunteers into 2 groups ( n = 10 each ) . Twenty-four hours after a 300 mg loading dose of clopidogrel , one group received a dosage of 75 mg/day of clopidogrel and a placebo for 14 days , followed 3 weeks later by the same protocol but with coadministration of 75 mg/day clopidogrel and 20 mg/day omeprazole instead . The other group received the same treatment but in reverse order . Antiplatelet activity was assessed in terms of the P2Y12 reaction unit ( PRU ) and percentage inhibition using a VerifyNow P2Y12 assay system . The PRU of the omeprazole-treated subjects was significantly higher than that of the omeprazole-untreated subjects on day 14 ( 281.3 + /- 54.0 versus 240.0 + /- 72.2 , P = 0.048 ) . The percentage inhibition showed a decrease after the 14-day omeprazole treatment ( 22.7 + /- 29.9 % versus 35.1 + /- 18.7 % , P = 0.014 ) . Consequently , omeprazole reduces the antiplatelet effect of clopidogrel , suggesting that careful treatment planning is required when administering omeprazole to patients on clopidogrel therapy Clinical efficacy of the antiplatelet drug clopidogrel is hampered by its variable biotransformation into the active metabolite . The variability in the clinical response to clopidogrel treatment has been attributed to genetic factors , but the specific genes and mechanisms underlying clopidogrel bioactivation remain unclear . Using in vitro metabolomic profiling techniques , we identified paraoxonase-1 ( PON1 ) as the crucial enzyme for clopidogrel bioactivation , with its common Q192R polymorphism determining the rate of active metabolite formation . We tested the clinical relevance of the PON1 Q192R genotype in a population of individuals with coronary artery disease who underwent stent implantation and received clopidogrel therapy . PON1 QQ192 homozygous individuals showed a considerably higher risk than RR192 homozygous individuals of stent thrombosis , lower PON1 plasma activity , lower plasma concentrations of active metabolite and lower platelet inhibition . Thus , we identified PON1 as a key factor for the bioactivation and clinical activity of clopidogrel . These findings have therapeutic implication s and may be exploited to prospect ively assess the clinical efficacy of clopidogrel Recent attention has been drawn to a potential drug-drug interaction observed between clopidogrel and proton pump inhibitors ( PPIs ) . However , this potential interaction may not be a class effect of PPIs . We investigated if pantoprazole , which has a different metabolism than omeprazole , diminishes the effectiveness of clopidogrel . Our study included 336 patients ( mean age 64.6 years ; 106 women ) 48 hours after percutaneous coronary stent implantation with a loading dose of 600 mg clopidogrel hydrogensulfate and 500 mg aspirin , followed by 75 mg clopidogrel and 100 mg aspirin daily . Whereas 188 patients ( 59 women ) were not given any PPI comedication , 122 patients received pantoprazole and 26 either omeprazole or esomeprazole . The platelet aggregation followed by impedance aggregometry ( in Ohm ) was induced by 5 μmol/L adenosine diphosphate . The percentage of clopidogrel low-response ( CLR ) was similar between the non-PPI group [ 2.75 Ohm ( confidence interval , CI : 2.25 - 3.26 ) ; 21.9 % CLR ] and the pantoprazole group [ 2.33 Ohm ( CI : 1.79 - 2.87 ) ; 16.4 % CLR ] but higher in patients treated with omeprazole/esomeprazole ( 3.00 Ohm ( CI : 1.49 - 4.51 ) ; 30.8 % CLR ) . Multivariate regression analysis reveals that the risk of CLR in the pantoprazole comedication group was not increased compared with the group without any PPI [ odds ratio 0.59 ( CI : 0.31 - 1.13 ) 0.11 ] . Our data suggest that pantoprazole does not diminish the antiplatelet effectiveness of clopidogrel early after coronary stenting . Therefore , the use of pantoprazole seems preferable in patients treated with clopidogrel when a concomitant medication with a PPI is indicated BACKGROUND Gastrointestinal complications are an important problem of antithrombotic therapy . Proton-pump inhibitors ( PPIs ) are believed to decrease the risk of such complications , though no r and omized trial has proved this in patients receiving dual antiplatelet therapy . Recently , concerns have been raised about the potential for PPIs to blunt the efficacy of clopidogrel . METHODS We r and omly assigned patients with an indication for dual antiplatelet therapy to receive clopidogrel in combination with either omeprazole or placebo , in addition to aspirin . The primary gastrointestinal end point was a composite of overt or occult bleeding , symptomatic gastroduodenal ulcers or erosions , obstruction , or perforation . The primary cardiovascular end point was a composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , revascularization , or stroke . The trial was terminated prematurely when the sponsor lost financing . RESULTS We planned to enroll about 5000 patients ; a total of 3873 were r and omly assigned and 3761 were included in analyses . In all , 51 patients had a gastrointestinal event ; the event rate was 1.1 % with omeprazole and 2.9 % with placebo at 180 days ( hazard ratio with omeprazole , 0.34 , 95 % confidence interval [ CI ] , 0.18 to 0.63 ; P<0.001 ) . The rate of overt upper gastrointestinal bleeding was also reduced with omeprazole as compared with placebo ( hazard ratio , 0.13 ; 95 % CI , 0.03 to 0.56 ; P = 0.001 ) . A total of 109 patients had a cardiovascular event , with event rates of 4.9 % with omeprazole and 5.7 % with placebo ( hazard ratio with omeprazole , 0.99 ; 95 % CI , 0.68 to 1.44 ; P = 0.96 ) ; high-risk subgroups did not show significant heterogeneity . The two groups did not differ significantly in the rate of serious adverse events , though the risk of diarrhea was increased with omeprazole . CONCLUSIONS Among patients receiving aspirin and clopidogrel , prophylactic use of a PPI reduced the rate of upper gastrointestinal bleeding . There was no apparent cardiovascular interaction between clopidogrel and omeprazole , but our results do not rule out a clinical ly meaningful difference in cardiovascular events due to use of a PPI . ( Funded by Cogentus Pharmaceuticals ; Clinical Trials.gov number , NCT00557921 . ) Background Proton pump inhibitors ( PPIs ) are usually prescribed to patients undergoing dual antiplatelet therapy to decrease the risk of gastrointestinal bleeding . Recent studies have raised concerns that PPIs could reduce clopidogrel 's efficacy by competitive inhibition of cytochrome P450 2C19 isoenzyme . All PPIs are metabolized by cytochrome P450 2C19 , although to varying degrees , and according to in-vitro studies , pantoprazole is the weakest inhibitor of this isoenzyme . We hypothesized that this drug interaction might not be a class effect . Methods One month after an acute myocardial infa rct ion 34 consecutive patients undergoing dual antiplatelet therapy were prospect ively analyzed . Platelet function was measured ( VerifyNow system ) , in each patient , in three consecutive clinical scenarios : ( i ) first , after a 1-month washout period , without any PPI , ( ii ) after a 4-week period taking omeprazole 40 mg , and ( iii ) after another 1-month washout period , followed by 4-weeks taking pantoprazole 40 mg . In this crossover trial , patients were first r and omized to receive either omeprazole or pantoprazole . Results We observed a significant reduction in clopidogrel 's effect when patients were initiated with omeprazole ; the mean P2Y12 reaction units ( PRU ) increased from 202±52 to 235±58 with omeprazole ( P<0.001 ) . With pantoprazole , clopidogrel efficacy was preserved ( PRU 215±54 , P=0.16 ) . Without any PPI , 26 % of patients were ‘ nonresponders ’ to clopidogrel ( PRU > 240 ) but when patients started omeprazole , this proportion increased to 45 versus 23 % with pantoprazole . Conclusion In this r and omized crossover study analyzing patients after acute myocardial infa rct ion , omeprazole coadministration showed a significant pharmacodynamic interaction with clopidogrel , whereas pantoprazole did not . These data suggest that the clopidogrel – PPIs drug interaction may not be a class effect Patients receiving dual antiplatelet treatment with aspirin and clopidogrel are commonly treated with proton pump inhibitors ( PPIs ) . Attenuating effects on platelet response to clopidogrel have been reported solely for the PPI omeprazole . PPIs differ in their metabolisation properties as well as their potential for drug-drug interactions . The aim of this study was to investigate the impact of different PPIs ( pantoprazole , omeprazole , esomeprazole ) on platelet response to clopidogrel in patients with previous coronary stent placement under chronic clopidogrel treatment . In a cross-sectional observational study , consecutive patients under clopidogrel maintenance treatment ( n = 1,000 ) scheduled for a control coronary angiography were enrolled . Adenosine diphosphate (ADP)-induced platelet aggregation ( in AU*min ) was measured with multiple electrode platelet aggregometry ( MEA ) . From the entire study population , 268 ( 26.8 % ) patients were under PPI treatment at the time point of platelet function testing ( pantoprazole , n = 162 ; omeprazole , n = 64 ; esomeprazole , n = 42 ) . Platelet aggregation ( median [ interquartile range ] ) was significantly higher in patients with omeprazole treatment ( 295.5 [ 193.5 - 571.2 ] AU*min ) compared to patients without PPI treatment ( 220.0 [ 143.8 - 388.8 ] AU*min ; p = 0.001 ) . Platelet aggregation was similar in patients with pantoprazole ( 226.0 [ 150.0 - 401.5 ] AU*min ) or esomeprazole ( 209.0 [ 134.8 - 384.8 ] AU*min ) treatment compared to patients without PPI treatment ( p = 0.69 and p = 0.88 , respectively ) . Attenuating effects of concomitant PPI treatment on platelet response to clopidogrel were restricted to the use of omeprazole . No attenuating effects on platelet response to clopidogrel were observed for pantoprazole or esomeprazole . Specifically design ed and r and omized clinical studies are needed to define the impact of concomitant PPI treatment on adverse events after percutaneous coronary intervention OBJECTIVES This study sought to compare the effect of 2 proton pump inhibitors ( PPIs ) on platelet response to clopidogrel after coronary stenting for non-ST-segment elevation acute coronary syndrome ( NSTE ACS ) . BACKGROUND Use of omeprazole has been reported to significantly decrease the clopidogrel antiplatelet effect because of cytochrome P450 interaction . Because all PPIs are metabolized by CYP2C19 , but to a varying degree , we hypothesized that the reported negative omeprazole-clopidogrel drug interaction may not be caused by a class effect . METHODS A total of 104 patients undergoing coronary stenting for NSTE ACS were prospect ively included and r and omized to omeprazole or pantoprazole 20 mg . They received at discharge 75-mg aspirin and 150-mg c \n Output:\n " }, { "from": "agent", "value": "Conclusion : Platelet function studies do not demonstrate a clear or consistent interaction between clopidogrel and PPIs .\nConsequently , platelet function data are of uncertain clinical relevance in determining the risk of an adverse cardiovascular interaction between PPIs and clopidogrel ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Implantation failure is one of the most important factors limiting success in IVF treatment . The majority of trials have demonstrated favorable effect of endometrial injury on implantation success rate especially in women with recurrent implantation failure , while some studies failed to detect any benefit . Objective : The purpose of our trial was to explore whether endometrial injury in luteal phase prior to frozen-thawed embryo transfer cycles would improve pregnancy outcomes ? Material s and Methods : We conducted a prospect i ve controlled trial of 93 consecutive subjects at a research and clinical center for infertility . All women were undergone frozen-thawed embryo transfer ( FTE ) cycles . Women in the experimental group underwent endometrial biopsy with a Pipelle catheter in luteal phase proceeding FET cycle . Primary outcomes were implantation and clinical pregnancy rates and secondary outcomes were chemical , ongoing and multiple pregnancy and miscarriage rates . Results : 45 subjects who underwent endometrial injury ( EI ) were compared with 48 control group which did not include any uterine manipulation . There were no significant differences in baseline and cycle characteristics between two groups . The difference in implantation rate was trend to statistically significance , 11.8 % in EI group vs. 20.5 % in control group ( p=0.091 ) . The chemical , clinical and ongoing pregnancy rates were lower in EI group compared with control group but not statistically significant . The multiple pregnancy rate and miscarriage rate also were lower in EI group compared with control group . Conclusion : Based on results of this study , local injury to endometrium in luteal phase prior to FET cycle had a negative impact on implantation and clinical pregnancy rates Purpose Endometrial biopsy preceding implantation in in vitro fertilization ( IVF ) treatment causes a type of injury which facilitates implantation . Pre-treatment hysteroscopic evaluation of uterine cavity also raises the success in IVF . This study investigates whether office hysteroscopy and concurrent endometrial biopsy performed in the luteal phase , on the day of GnRH agonist initiation for long protocol , improves subsequent IVF outcome . Methods A prospect i ve , nonr and omized , controlled study of 128 normoresponder women was performed : In 70 women ( study group ) , office hysteroscopy and concurrent endometrial biopsy were performed on the day of GnRH agonist initiation preceding ET cycle and in 58 women ( control group ) , GnRH agonist was initiated without any intervention . However , uterine cavity was shown to be normal with hysteroscopy within the previous 6 months in those women . Implantation and pregnancy rates were compared between the groups . Results Intrauterine pathologies were observed in 28 % of women in the study group . Implantation rate ( 38 vs. 25 % ; p = 0.04 ) and pregnancy rate per ET ( 67 vs. 45 % ; p = 0.01 ) were found to be significantly higher in the study group compared to the control group . Conclusion Office hysteroscopy and concurrent endometrial biopsy performed in the luteal phase , on the day of GnRH agonist initiation for long protocol , provide direct evaluation of the uterine cavity immediately before ET cycle and also significantly improve the implantation and IVF outcome OBJECTIVE To explore the possibility that endometrial injury modulates the expression of specific genes that may increase uterine receptivity . DESIGN Controlled clinical study . SETTING Clinical IVF unit and academic research center . PATIENT(S ) IVF patients with 28- to 30-day menstrual cycles . INTERVENTION(S ) Endometrial biopsies from two groups of patients were collected on days 20 - 21 of their spontaneous menstrual cycle . The experimental , but not the control , group underwent biopsies on days 11 - 13 and 21 - 24 of their preceding cycle . MAIN OUTCOME MEASURE(S ) Global endometrial gene expression and specific analysis of uroplakin Ib ( UPIb ) mRNA level throughout the menstrual cycle . RESULT ( S ) Local injury modulated the expression of a wide variety of genes . One of the prominently up-regulated genes was the bladder transmembranal protein , UPIb , whose expression by the endometrium is shown here for the first time . Endometrial UPIb mRNA increases after biopsy in the same cycle wct 2with an additional elevation in the following cycle . Immunohistochemical analysis localized the UPIb protein to the gl and ular-epithelial cells . Genes encoding other membrane proteins such as adipose differentiation-related protein and mucin 1 , transmembrane , were also up-regulated . CONCLUSION ( S ) The biopsy-induced increase in the expression of UPIb and other genes encoding membrane proteins supports the possible importance of the membrane structure and stability during implantation . The specific role of UPIb in uterine receptivity should be eluci date Background Mechanical endometrial injury prior to IVF has been suggested as a means to increase implantation rates by improving endometrial receptivity . However , the effects of endometrial injury in proliferative vs. luteal phase have not been studied before . This study aim ed to explore whether endometrial injury in the proliferative phase of the preceding cycle before in vitro fertilization/embryo transfer ( IVF-ET ) improves the clinical outcomes in unselected subfertile women compared with injury in luteal phase . Methods A group of 142 patients who were good responders to hormonal stimulation were r and omized into four groups : injury group ( group A : endometrial injury in proliferative phase , n = 38 ; group B : endometrium injury in luteal phase , n = 32 ) , and non-injury group as control ( group C : non-injury in proliferative phase , n = 36 ; group D : non-injury in luteal phase , n = 36 ) . Patients in injury groups underwent endometrial injury in either proliferative phase or luteal phase in the preceding cycle before IVF treatment . Clinical outcomes including implantation , pregnancy , and live birth rates were analyzed among the four groups . Results The baseline characteristics of the four groups including age , body mass index , duration , type and causes of infertility were similar . There were no significant differences in implantation , clinical pregnancy or live birth rates between injury group and non-injury group . Moreover , there were also no significant differences in implantation , clinical pregnancy , or live birth rates in injury in proliferative phase compared with luteal phase . Conclusions Endometrial injury in the cycle preceding IVF of unselected subfertile women does not increase implantation , clinical pregnancy , or live birth rates . Furthermore , there is no significant difference in clinical outcomes between endometrial injury in the proliferative phase and injury in the luteal phase . Trial registration This study was retrospectively registered on May 26th , 2017 ( ChiCTR-IOR-17011506 ) OBJECTIVE To evaluate the effectiveness of local endometrial injury in women undergoing in vitro fertilization ( IVF ) with at least one previous unsuccessful attempt . STUDY DESIGN R and omized controlled trial . Recruited women were r and omized into two groups . In group A ( pipelle group ) , women underwent pipelle biopsy twice in the luteal phase in the cycle prior to IVF . In group B ( control ) , women did not undergo any intervention prior to IVF . The primary outcome was clinical pregnancy rate . The secondary outcomes included live birth , miscarriage , multiple pregnancy and preterm delivery rates . RESULTS One hundred and eleven women were included in the study with 55 in the pipelle group and 56 in the control arm . The baseline clinical characteristics were similar in both groups . The clinical pregnancy rates were not significantly different between pipelle and control group ( 34.09 % vs. 27.65 % ; Odds ratio , OR 1.35 , 95 % confidence interval , CI 0.55 - 3.30 ) . The live birth ( 31.81 % vs. 25.53 % ; OR 1.36 , 95 % CI 0.55 - 3.39 ) , multiple pregnancy ( 33.33 % vs. 61.54 % ; OR 0.31 , 95 % CI 0.07 - 1.47 ) , miscarriage ( 6.66 % vs. 7.69 % ; OR 0.86 , 95 % CI 0.05 - 15.23 ) and preterm delivery rates ( 35.71 % vs. 66.66 % ; OR 0.28 , 95 % CI 0.05 - 1.4 ) were also not significantly different between the two groups . CONCLUSION Current study did not find any improvement in IVF success rates following endometrial injury in woman undergoing IVF after previous failed attempt STUDY QUESTION Is recurrent implantation failure ( RIF ) associated with decreased expression of platelet and endothelial cell adhesion molecule 1 ( PECAM1 ) and transforming growth factor β1 ( TGF-β1 ) in the endometrium during the implantation window ? SUMMARY ANSWER The present study demonstrates that the expression of PECAM1 and TGF-β1 is significantly decreased in the mid-secretory endometrium in women with RIF , which may account for embryo implantation failure . WHAT IS KNOWN ALREADY RIF has become a bottleneck issue that hampers the improvement of pregnancy rates in IVF-embryo transfer ( IVF-ET ) . The causes of RIF are complex and may involve the dysregulation of various growth factors , metabolites , and inflammatory cytokines . At present , the precise pathogenesis of RIF has not been eluci date d. STUDY DESIGN , SIZE , DURATION This was a prospect i ve case-control study . Endometrial tissue sample s were obtained from January 2014 to December 2016 from two groups of women who had undergone IVF ( RIF group , 22 women who underwent ≥3 ETs including a total of ≥4 good- quality embryos without pregnancy , control group , 18 women who conceived in their first treatment cycle ) . At the same time , sample s were obtained from 18 women with infertility secondary to tubal factor in the early proliferative , late proliferative and mid-secretory phases of the menstrual cycle ( n = 6 per group ) . Sample s used for isolation of primary human endometrial epithelial cells and stromal cells ( HEECs and HESCs ) were collected in December 2017 from six women with infertility secondary to tubal factor . PARTICIPANTS / MATERIAL S , SETTING , METHODS We investigated gene expression using integrative whole genome expression microarray analysis , including differentially expressed gene screening , principal component analysis , and functional enrichment analysis . RT-qPCR , western blotting , immunohistochemistry , immunofluorescence co-localization analysis and short hairpin RNA ( shRNA ) plasmid transfection in Ishikawa cell line , HEECs and HESCs were used to investigate the expression of PECAM1 and TGF-β1 . MAIN RESULTS AND THE ROLE OF CHANCE Integrative data mining of whole-genome expression profiles identified cell adhesion as a key regulator in RIF . Data base retrieval and literature review screened several novel cell adhesion-related genes that might participate in embryo implantation , which include PECAM1 , intercellular adhesion molecule 2 ( ICAM2 ) , integrin subunit β2 ( ITGB2 ) , selectin P ( SELP ) and TEK receptor tyrosine kinase ( TEK ) . Among these targets , the mRNA and protein levels of PECAM1 were significantly lower in the RIF group than those in the control group . During the menstrual cycles of women with secondary infertility , the protein expression level of PECAM1 was the lowest in early proliferative phase , slightly increased in late proliferative phase and was the highest in mid-secretory phase . While the expression level of HOXA10 , an endometrial receptivity marker , kept at a low level in early proliferative phase and increased in late proliferative phase , then maintained at a high level in the mid-secretory phase . Furthermore , TGF-β1 , mediated by PECAM1 , was also decreased significantly in the RIF group . Using shRNA-based approach , we demonstrated that the depletion of PECAM1 significantly decreased the expression of TGF-β1 in Ishikawa cells , as well as in primary HEECs and HESCs . These results indicated that PECAM1 and TGF-β1 might play a pivotal role in modulating endometrial receptivity . LIMITATIONS REASONS FOR CAUTION Although we have shown that PECAM1 and TGF-β1 were down-regulated in the women with RIF , the molecular mechanism of the effect of the factors on the endometrial receptivity remain unclear . WIDER IMPLICATION S OF THE FINDINGS Our findings provide insight into the contribution of PECAM1 and TGF-β1 in regulating implantation , which could be used to develop potential therapeutic methods for RIF . STUDY FUNDING /COMPETING INTEREST(S ) This work was supported by grants from the National Natural Science Foundation of China ( Nos. 81771656 and 81370763 ) , Special fund for clinical research of the Chinese Medical Association ( No. 16020480664 ) , and the Merck Serono China Research Fund for Fertility Agreement . The authors have no competing interests BACKGROUND The success rate of in-vitro fertilisation ( IVF ) remains low and many women undergo multiple treatment cycles . A previous meta- analysis suggested hysteroscopy could improve outcomes in women who have had recurrent implantation \n Output:\n " }, { "from": "agent", "value": "There is still insufficient evidence to support the use of endometrial injury in women with implantation failure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE The aim of this study was to evaluate the effectiveness of 904-nm low-level laser therapy ( LLLT ) in the management of lateral epicondylitis . BACKGROUND DATA Lateral epicondylitis is characterized by pain and tenderness over the lateral elbow , which may also result in reduction in grip strength and impairment in physical function . LLLT has been shown effective in its therapeutic effects in tissue healing and pain control . METHODS Thirty-nine patients with lateral epicondylitis were r and omly assigned to receive either active laser with an energy dose of 0.275 J per tender point ( laser group ) or sham irradiation ( placebo group ) for a total of nine sessions . The outcome measures were mechanical pain threshold , maximum grip strength , level of pain at maximum grip strength as measured by the Visual Analogue Scale ( VAS ) and the subjective rating of physical function with Disabilities of the Arm , Shoulder and H and ( DASH ) question naire . RESULTS Significantly greater improvements were shown in all outcome measures with the laser group than with the placebo group ( p < 0.0125 ) , except in the two subsections of DASH . CONCLUSION This study revealed that LLLT in addition to exercise is effective in relieving pain , and in improving the grip strength and subjective rating of physical function of patients with lateral epicondylitis HE first placebo-controlled trial was probably conducted in 1931 , when sanocrysin was compared with distilled water for the treatment of tuberculosis . 1 Ever since then , placebo-controlled trials have been controversial , especially when patients r and omly assigned to receive placebo have forgone effective treatments . 2 - 5 Recently , the debate has become polarized . One view , dubbed \" placebo orthodoxy \" by its opponents , is that method ologic considerations make placebo-controlled trials necessary . 6 - 11 The other view , which might be called \" active-control ortho-doxy , \" is that placebo orthodoxy sacrifices ethics and the rights and welfare of patients to presumed scientific rigor . 10 - 14 The latest revision of the Declaration of Helsinki , although controversial , 15,16 embraces the active-control orthodoxy . 17 Both views discount the ethical and method ologic complexities of clinical research . In this essay , we argue that placebo-controlled trials are permissible when proven therapies exist , but only if certain ethical and method ologic criteria are met . Advocates of placebo-controlled studies argue that it is ethical to conduct such trials even in the case of medical conditions for which there are interventions known to be effective , because of the method ologic limitations of trials in which active treatment is used as the control . 6 - 9 Sometimes therapies that are known to be effective are no better than placebo in particular trials because of variable responses to drugs in particular population s , unpredictable and small effects , and high rates of spontaneous improvement in patients . Consequently , without a placebo group to ensure validity , the finding that there is no difference between the investigational and st and ard treatments can be misleading or uninterpretable . 8,9 New treatments that are no better than existing treatments may still be clinical ly valuable if they have fewer side effects or are more effective for particular subgroups of patients . 18 However , no drug should be approved for use in patients unless it is clearly superior to placebo or no treatment . Despite the method ologic rigor of placebo-controlled trials , commentators acknowledge that they are unethical in some circumstances , especially when withholding an effective treatment might be life-threatening or might cause serious morbidity . There are serious problems with placebo orthodoxy . First , in our opinion , the criteria for ethical use of T placebo controls are never precisely stated . In a recent review , for instance , Temple and Ellenberg 8,9 cl aim ed that the use of placebo controls is ethical if the research participants who receive placebo will experience \" no permanent adverse consequence , \" if there is OBJECTIVE This study was undertaken to compare the effectiveness of a protocol of combination of laser with plyometric exercises and a protocol of placebo laser with the same program , in the treatment of tennis elbow . BACKGROUND DATA The use of low-level laser has been recommended for the management of tennis elbow with contradictory results . Also , plyometric exercises was recommended for the treatment of the tendinopathy . METHODS Fifty patients who had tennis elbow participated in the study and were r and omised into two groups . Group A ( n = 25 ) was treated with a 904 Ga-As laser CW , frequency 50 Hz , intensity 40 mW and energy density 2.4 J/cm(2 ) , plus plyometric exercises and group B ( n = 25 ) that received placebo laser plus the same plyometric exercises . During eight weeks of treatment , the patients of the two groups received 12 sessions of laser or placebo , two sessions per week ( weeks 1 - 4 ) and one session per week ( weeks 5 - 8 ) . Pain at rest , at palpation on the lateral epicondyle , during resisted wrist extension , middle finger test , and strength testing was evaluated using Visual Analogue Scales . Also it was evaluated the grip strength , the range of motion and weight test . Parameters were determined before the treatment , at the end of the eighth week course of treatment ( week 8) , and eighth ( week 8) after the end of treatment . RESULTS Relative to the group B , the group A had ( 1 ) a significant decrease of pain at rest at the end of 8 weeks of the treatment ( p < 0.005 ) and at the end of following up period ( p < 0.05 ) , ( 2 ) a significant decrease in pain at palpation and pain on isometric testing at 8 weeks of treatment ( p < 0.05 ) , and at 8 weeks follow-up ( p < 0.001 ) , ( 3 ) a significant decrease in pain during middle finger test at the end of 8 weeks of treatment ( p < 0.01 ) , and at the end of the follow-up period ( p < 0.05 ) , ( 4 ) a significant decrease of pain during grip strength testing at 8 weeks of treatment ( p < 0.05 ) , and at 8 weeks follow-up ( p < 0.001 ) , ( 5 ) a significant increase in the wrist range of motion at 8 weeks follow-up ( p < 0.01 ) , ( 6 ) an increase in grip strength at 8 weeks of treatment ( p < 0.05 ) and at 8 weeks follow-up ( p < 0.01 ) , and ( 7 ) a significant increase in weight-test at 8 weeks of treatment ( p < 0.05 ) and at 8 weeks follow-up ( p < 0.005 ) . CONCLUSION The results suggested that the combination of laser with plyometric exercises was more effective treatment than placebo laser with the same plyometric exercises at the end of the treatment as well as at the follow-up . Future studies are needed to establish the relative and absolute effectiveness of the above protocol Background : Low level laser therapy ( LLLT ) has gained increasing popularity in the management of tendinopathy and arthritis . Results from in vitro and in vivo studies have suggested that inflammatory modulation is one of several possible biological mechanisms of LLLT action . Objective : To investigate in situ if LLLT has an anti-inflammatory effect on activated tendinitis of the human Achilles tendon . Subjects : Seven patients with bilateral Achilles tendinitis ( 14 tendons ) who had aggravated symptoms produced by pain inducing activity immediately before the study . Method : Infrared ( 904 nm wavelength ) LLLT ( 5.4 J per point , power density 20 mW/cm2 ) and placebo LLLT ( 0 J ) were administered to both Achilles tendons in r and om blinded order . Results : Ultrasonography Doppler measurements at baseline showed minor inflammation through increased intratendinous blood flow in all 14 tendons and measurable resistive index in eight tendons of 0.91 ( 95 % confidence interval 0.87 to 0.95 ) . Prostagl and in E2 concentrations were significantly reduced 75 , 90 , and 105 minutes after active LLLT compared with concentrations before treatment ( p = 0.026 ) and after placebo LLLT ( p = 0.009 ) . Pressure pain threshold had increased significantly ( p = 0.012 ) after active LLLT compared with placebo LLLT : the mean difference in the change between the groups was 0.40 kg/cm2 ( 95 % confidence interval 0.10 to 0.70 ) . Conclusion : LLLT at a dose of 5.4 J per point can reduce inflammation and pain in activated Achilles tendinitis . LLLT may therefore have potential in the management of diseases with an inflammatory component Abstract A r and omized , double‐blind , placebo‐controlled study of low‐level laser therapy ( LLLT ) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300 mW , 830 nm laser in the management of chronic neck pain . Subjects were r and omized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck . The primary outcome measure was change in a 10 cm Visual Analogue Scale ( VAS ) for pain . Secondary outcome measures included Short‐Form 36 Quality ‐of‐Life question naire ( SF‐36 ) , Northwick Park Neck Pain Question naire ( NPNQ ) , Neck Pain and Disability Scale ( NPAD ) , the McGill Pain Question naire ( MPQ ) and Self‐Assessed Improvement ( SAI ) in pain measured by VAS . Measurements were taken at baseline , at the end of 7 weeks ' treatment and 12 weeks from baseline . The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group ( difference 3.0 , 95 % CI 3.8–2.1 ) . Significant improvements were seen in the active group compared to placebo for SF‐36‐Physical Score ( SF36 PCS ) , NPNQ , NPAD , MPQVAS and SAI . The results of the SF‐36 – Mental Score ( SF36 MCS ) and other MPQ component scores ( afferent and sensory ) did not differ significantly between the two groups . Low‐level laser therapy ( LLLT ) , at the parameters used in this study , was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Background Eccentric exercises ( EEs ) are recommended for the treatment of Achilles tendinopathy , but the clinical effect from EE has a slow onset . Hypothesis The addition of low-level laser therapy ( LLLT ) to EE may cause more rapid clinical improvement . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods A total of 52 recreational athletes with chronic Achilles tendinopathy symptoms were r and omized to groups receiving either EE + LLLT or EE + placebo LLLT over 8 weeks in a blinded manner . Low-level laser therapy ( Λ = 820 nm ) was administered in 12 sessions by irradiating 6 points along the Achilles tendon with a power density of 60 mW/cm2 and a total dose of 5.4 J per session . Results The results of the intention-to-treat analysis for the primary outcome , pain intensity during physical activity on the 100-mm visual analog scale , were significantly lower in the LLLT group than in the placebo LLLT group , with 53.6 mm versus 71.5 mm ( P = .0003 ) at 4 weeks , 37.3 mm versus 62.8 mm ( P = .0002 ) at 8 weeks , and 33.0 mm versus 53. \n Output:\n " }, { "from": "agent", "value": "LLLT can potentially be effective in treating tendinopathy when recommended dosages are used .\nThe 12 positive studies provide strong evidence that positive outcomes are associated with the use of current dosage recommendations for the treatment of tendinopathy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objectives To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations . Methods This was a prospect i ve , multicentre cohort study with 532 HIV-infected patients receiving nevirapine as a part of their initial antiretroviral therapy . Plasma sample s were collected at trough or peak time at the end of week 2 ( lead-in period ) and week 4 , 12 , 24 , 36 , and 48 ( steady-state period ) , and nevirapine concentrations were determined using a vali date d HPLC method . Potential influencing factors associated with nevirapine concentrations were evaluated using univariate and multivariate logistic regression . Results A total of 2348 nevirapine plasma concentrations were collected , including 1510 trough and 838 peak values . The median nevirapine trough and peak concentration during the lead-in period were 4.26 µg/mL ( IQR 3.05–5.61 ) and 5.07 µg/mL ( IQR 3.92–6.44 ) respectively , which both exceeded the recommended thresholds of nevirapine plasma concentrations . Baseline hepatic function had a moderate effect on median nevirapine trough concentrations at week 2 ( 4.25 µg/mL v.s. 4.86 µg/mL , for ALT < 1.5 × ULN and ≥1.5 × ULN , respectively , P = 0.045 ) . No significant difference was observed in median nevirapine trough concentration between lead-in and steady-state periods in patients with baseline ALT and AST level ≥1.5 × ULN ( P = 0.171 , P = 0.769 ) , which was different from the patients with ALT/AST level < 1.5ULN . The median trough concentrations were significantly higher in HIV/HCV co-infected patients than those without HCV at week 48 ( 8.16 µg/mL v.s. 6.15 µg/mL , P = 0.004 ) . Conclusions The 200 mg once-daily regimen of nevirapine might be comparable to twice-daily in plasma pharmacokinetics in Chinese population . Hepatic function prior to nevirapine treatment and HIV/HCV coinfection were significantly associated with nevirapine concentrations . Registration Clinical trial.gov ID : Purpose Sexually transmitted infections ( STIs ) occur frequently in risk population s. Hereby , the role of screening-programmes remains controversial . Our study aim ed to determine the prevalence of STI infections in HIV-positive men-who-have-sex-with-men ( MSM ) . Methods We enrolled asymptomatic , HIV-MSM in a prospect i ve cross-sectional study from February to August 2016 at seven German HIV-centres . All subjects were screened for Treponema-pallidum ( TP ) and hepatitis-B/C-infection . HIV RNA and screening for oral , rectal and urethral colonisation by Chlamydia-trachomatis ( CT ) and /or Neisseria-gonorrhoeae ( NG ) was performed . All subjects were asked to complete a sexual-risk-behaviour- question naire . Results In total , 296 subjects with a median age of 43.2 ( 36.2–49.5 ) years were enrolled ; 99.3 % were on ART for 5.5 ( 2.3–11.2 ) years . HIV RNA was < 50 copies/mL in 93.6 % . Active syphilis infection was found in 5.0 % of all patients , whereas 55.4 % had history of infection . HCV seropositivity was found in 33 patients ( 13.2 % ) and positive HCV RNA was available in 39.4 % . 66/294 ( 22.5 % ) showed negative anti-HBs-antibodies , indicating lack of immunity . Overall , 40/296 ( 13.5 % ) had positive CT/NG swabs ( CT in 8.8 % ; 7.3 % anorectal , 1.7 % oropharyngeal , 1.0 % urethral and NG in 6.8 % ; 4.5 % anal , 2.0 % oropharyngeal , 1.4 % urethral ) . Time since HIV infection < 7 years ( OR 2.6 ( 1.2–5.5 ) ; p = 0.012 ) , the use of inhalative nitrites ( “ poppers ” ) ( OR 2.8 ( 1.3–5.9 ; p = 0.008 ) and reporting unprotected intercourse with > 20 partners within the last 6 months [ OR 3.0 ( 1.2–7.8 ) ; p = 0.003 ] were significantly associated in multivariate analysis . Conclusion We found high numbers of asymptomatic syphilis , hepatitis-C and CT/NG infections in HIV-MSM , remarkably in patients with shorter duration of HIV-infection with more sexual partners within last 6 months OBJECTIVES This study was design ed to assess the prevalence of HBV and HCV infection in HIV patients and evaluate the risk of infection compared with HIV negative control subjects . METHOD This is a prospect i ve case control study in which 240 HIV/AIDS patients and age and sex matched controls were evaluated . The diagnosis of HIV infection was based on a positive HIV screening test using Capillus test kits ( Trinity Biotech PLC , Irel and ) and confirmed using Western blot assay . HBsAg and anti-HCV were assayed by commercially available chromatographic immunoassay ( SD BIOLINE ) . RESULTS Eleven ( 9.2 % ) of the 120 HIV/AIDS patients and 8 ( 7 % ) of the 120 control subjects were positive for the HBsAg ( OR=1 , p=0.27 ) . HBeAg was detected in 3 of the 11 ( 27.3 % ) subjects with HIV/HBV co infections . HIV positive patients were 7 times more likely to have HCV infection than control patients ( 5.8 % compared with 0.8 % , OR=7.3 , p= 0.03 ) . CONCLUSION The lack of a strong association between HBV and HIV infection may be related to different exposure routes in this population where HBV infection is highly endemic and childhood infection almost universal . In this African population , HIV infection may be a super-infection of HBV infections contracted in childhood . This high HCV/HIV co-infection rate is consistent with the shared parenteral and sexual routes of transmission The purpose of this study is to determine the rate of human immunodeficiency virus ( HIV ) and hepatitis B surface antigen ( HBsAg ) among commercial blood donors in the University of Benin Teaching Hospital . Five thous and seven hundred and thirty-seven prospect i ve commercial blood donors were screened for both HIV and HBsAg . Three hundred and eighty-three ( 7 % ) donors were positive for HIV while 609 donors ( 11 % ) were positive for HBsAg . Thirty-seven donors were positive for both HIV and HBsAg . The need to make the screening of blood donors for HIV and HBsAg compulsory in all hospitals is crucial so that the spread of HIV and HBsAg can be prevented BACKGROUND An increasing proportion of deaths among human immunodeficiency virus (HIV)-infected persons with access to combination antiretroviral therapy ( cART ) are due to complications of liver diseases . METHODS We investigated the frequency of and risk factors associated with liver-related deaths in the Data Collection on Adverse Events of Anti-HIV Drugs study , which prospect ively evaluated 76 893 person-years of follow-up in 23 441 HIV-infected persons . Multivariable Poisson regression analyses identified factors associated with liver-related , AIDS-related , and other causes of death . RESULTS There were 1246 deaths ( 5.3 % ; 1.6 per 100 person-years ) ; 14.5 % were from liver-related causes . Of these , 16.9 % had active hepatitis B virus ( HBV ) , 66.1 % had hepatitis C virus ( HCV ) , and 7.1 % had dual viral hepatitis co-infections . Predictors of liver-related deaths were latest CD4 cell count ( adjusted relative rate [ RR ] , 16.1 ; 95 % confidence interval [ CI ] , 8.1 - 31.7 for < 50 vs > or = 500/microL ) , age ( RR , 1.3 ; 95 % CI , 1.2 - 1.4 per 5 years older ) , intravenous drug use ( RR , 2.0 ; 95 % CI , 1.2 - 3.4 ) , HCV infection ( RR , 6.7 ; 95 % CI , 4.0 - 11.2 ) , and active HBV infection ( RR , 3.7 ; 95 % CI , 2.4 - 5.9 ) . Univariable analyses showed no relationship between cumulative years patients were receiving cART and liver-related death ( RR , 1.00 ; 95 % CI , 0.93 - 1.07 ) . Adjustment for the most recent CD4 cell count and patient characteristics result ed in an increased risk of liver-related mortality per year of mono or dual antiretroviral therapy before cART ( RR , 1.09 ; 95 % CI , 1.02 - 1.16 ; P = .008 ) and per year of cART ( RR , 1.11 ; 95 % CI , 1.02 - 1.21 ; P = .02 ) . CONCLUSIONS Liver-related death was the most frequent cause of non-AIDS-related death . We found a strong association between immunodeficiency and risk of liver-related death . Longer follow-up is required to investigate whether clinical ly significant treatment-associated liver-related mortality will develop ABSTRACT Outbreaks of sexually transmitted hepatitis C virus ( HCV ) infections have been recently reported in HIV-infected men who have sex with men ( MSM ) in Europe , Australia , and North America . Little is known concerning whether this also occurs in other Asia-Pacific countries . Between 1994 and 2010 , a prospect i ve observational cohort study was performed to assess the incidence of recent HCV seroconversion in 892 HIV-infected patients ( 731 MSM and 161 heterosexuals ) who were not injecting drug users . A nested case-control study was conducted to identify associated factors with recent HCV seroconversion , and phylogenetic analysis was performed using NS5B sequences amplified from seroconverters . During a total followup duration of 4,270 person-years ( PY ) , 30 patients ( 3.36 % ) had HCV seroconversion , with an overall incidence rate of 7.03 per 1,000 PY . The rate increased from 0 in 1994 to 2000 and 2.29 in 2001 to 2005 to 10.13 per 1,000 PY in 2006 to 2010 ( P < 0.05 ) . After adjustment for age and HIV transmission route , recent syphilis remained an independent factor associated with HCV seroconversion ( odds ratio , 7.731 ; 95 % confidence interval , 3.131 to 19.086 ; P < 0.01 ) . In a nested case-control study , seroconverters had higher aminotranferase levels and were more likely to have CD4 ≥ 200 cells/μl and recent syphilis than nonseroconverters ( P < 0.05 ) . Among the 21 patients with HCV viremia , phylogenetic analysis revealed 7 HCV transmission clusters or pairs ( 4 within genotype 1b , 2 within genotype 2a , and 1 within genotype 3a ) . The incidence of HCV seroconversion that is associated with recent syphilis is increasing among HIV-infected patients in Taiwan Objectives Men who have sex with men ( MSM ) are at higher risk for coinfection with hepatitis B virus ( HBV ) , hepatitis C virus ( HCV ) , and syphilis than the general population . HIV infection and these coinfections accelerate disease progression reciprocally . This study evaluated the prevalence and incidence of these coinfections in HIV1-positive MSM in Germany . Material s and Methods As part of a nationwide , multicenter , prospect i ve cohort study of HIV-infected MSM , plasma sample s collected yearly were screened for HBsAg and antibodies to HBc , HBs , HCV , and syphilis . Sample s with indications of active HBV or HCV infection were confirmed by polymerase chain reaction . Prevalence and incidence of each infection and incidence rates per study participant were calculated , and incidences over 4-year time intervals compared . Results This study screened 5,445 sample s from 1,843 MSM . Median age at HIV seroconversion was 33 years . Prevalences of active , cleared , and occult HBV , and of active/cleared HCV were 1.7 % , 27.1 % , 0.2 % , and 8.2 % , respectively , and 4 \n Output:\n " }, { "from": "agent", "value": "The global scale-up of HIV treatment for PLHIV using a tenofovir-based ART regimen provides an opportunity to simultaneously treat those with HBsAg co-infection and reduce mother-to-child transmission of HBV alongside HIV" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study aim ed to assess the influence of different whole body vibration ( WBV ) determinants on the electromyographic ( EMG ) activity during WBV in order to identify those training conditions that cause highest neuromuscular responses and therefore provide optimal training conditions . In a r and omized cross-over study , the EMG activity of six leg muscles was analyzed in 18 subjects with respect to the following determinants : ( 1 ) vibration type ( side-alternating vibration ( SV ) vs. synchronous vibration ( SyV ) , ( 2 ) frequency ( 5–10–15–20–25–30 Hz ) , ( 3 ) knee flexion angle ( 10 ° –30 ° –60 ° ) , ( 4 ) stance condition ( forefoot vs. normal stance ) and ( 5 ) load variation ( no extra load vs. additional load equal to one-third of the body weight ) . The results are : ( 1 ) neuromuscular activity during SV was enhanced compared to SyV ( P < 0.05 ) ; ( 2 ) a progressive increase in frequency caused a progressive increase in EMG activity ( P < 0.05 ) ; ( 3 ) the EMG activity was highest for the knee extensors when the knee joint was 60 ° flexed ( P < 0.05 ) ; ( 4 ) for the plantar flexors in the forefoot stance condition ( P < 0.05 ) ; and ( 5 ) additional load caused an increase in neuromuscular activation ( P < 0.05 ) . In conclusion , large variations of the EMG activation could be observed across conditions . However , with an appropriate adjustment of specific WBV determinants , high EMG activations and therefore high activation intensities could be achieved in the selected muscles . The combination of high vibration frequencies with additional load on an SV platform led to highest EMG activities . Regarding the body position , a knee flexion of 60 ° and forefoot stance appear to be beneficial for the knee extensors and the plantar flexors , respectively BACKGROUND Low back disorders and their prevention is of great importance for companies and their employees . Whole-body vibration is thought to be a risk factor for low back disorders , but the neuromuscular , biomechanical , and /or physiological mechanisms responsible for this increased risk are unclear . The purpose of this study was to measure the acute effect of seated whole-body vibration on the postural control of the trunk during unstable seated balance . METHODS Twenty-one healthy subjects ( age : 23 years ( SD 4 years ) ) were tested on a wobble chair design ed to measure trunk postural control . Measurements of kinematic variance and non-linear stability control were based on seat angle before and after 30 min of seated whole-body vibration ( b and width=2 - 20 Hz , root-mean-squared amplitude=1.15m/s(2 ) ) . FINDINGS All measures of kinematic variance of unstable seated balance increased ( P<0.05 ) after vibration including : ellipse area ( 35.5 % ) , root-mean-squared radial lean angle ( 17.9 % ) , and path length ( 12.2 % ) . Measures of non-linear stability control also increased ( P<0.05 ) including Lyapunov exponent ( 8.78 % ) , stability diffusion analysis ( 1.95 % ) , and Hurst rescaled range analysis ( 5.2 % ) . INTERPRETATION Whole-body vibration impaired postural control of the trunk as evidence d by the increase in kinematic variance and non-linear stability control measures during unstable sitting . These findings imply an impairment in spinal stability and a mechanism by which vibration may increase low back injury risk . Future work should investigate the effects of whole-body vibration on the anatomical and neuromuscular components that contribute to spinal stability The purpose of this study was to investigate the consequences of a high-speed boat transit on physical performance . Twenty-four Royal Marines were r and omly assigned to a control ( CON ) or transit ( TRAN ) group . The CON group sat onshore for 3 h whilst the TRAN group completed a 3-h transit in open-boats running side-by-side , at 40 knots in moderate-to-rough seas , with boat deck and seat-pan acceleration recorded . Performance tests ( exhaustive shuttle-run , h and grip , vertical-jump , push-up ) were completed pre- and immediately post-transit/sit , with peak heart rate ( HRpeak ) and rating of perceived exertion ( RPE ) recorded . Serial blood sample s ( pre , 24 , 36 , 48 , 72 h ) were analyzed for creatine kinase ( CK ) activity . The transit was typified by frequent high shock impacts , but moderate mean heart rates ( < 45 % HRpeak ) . The TRAN group post-transit run distance ( −219 m , P < 0.01 ) and vertical-jump height ( 5 % , P < 0.05 ) were reduced , the CON group showed no change . The TRAN group post-transit test RPE increased ( P < 0.05 ) , however , HRpeak was similar for each group ( 98 % ) . Post-transit CK activity increased in the TRAN group up to 72 h ( P < 0.01 ) and also , but less markedly , in the CON group ( 24 and 48 h , P < 0.05 ) . Post-transit run and jump performances were reduced despite mean transit heart rates indicating low energy expenditure . The greater TRAN CK activity suggests muscle damage may have been a contributory factor . These findings have operational implication s for Special Forces/naval/police/rescue services carrying out dem and ing , high-risk physical tasks during and immediately after high-speed boat transits Underst and ing of the resonance behaviour of the human body is important in the identification of vibration frequencies and body postures associated with back problems . In this study , experimental modal analysis was applied to whole-body vibration . Eight subjects were exposed to vertical r and om vibration while adopting three different postures on a rigid seat without a backrest . Motions of the spine , pelvis and viscera in the mid-sagittal plane were derived from skin-mounted accelerometers ; head responses were measured using a bite-bar . Eight modes of vibration response were extracted below 10 Hz . A principal resonance of the human body at about 5 Hz consisted of an entire body mode , in which the skeleton moved vertically due to axial and shear deformations of buttocks tissue , in phase with a vertical visceral mode , and a bending mode of the upper thoracic and cervical spine . A bending mode of the lumbar and lower thoracic spine was found with a pitching mode of the head in the next higher mode located close to the principal mode . The second principal resonance at about 8 Hz corresponded to pitching modes of the pelvis and a second visceral mode . When subjects changed posture from erect to slouched , the natural frequency of the entire body mode decreased , result ing in a decrease in the principal resonance frequency . Shear deformation of buttocks tissue increased in the entire body mode due to the same change of posture . The complex body motions suggest that any forces causing injury from whole-body vibration will not be well-predicted by biodynamic models incapable of representing the appropriate body motions and the effects of body posture . It seems likely that the greatest risk of back problems will arise from the bending deformations of the spine STUDY DESIGN A cross-sectional study in patients with recurrent/chronic low back trouble and healthy control subjects . OBJECTIVE To evaluate the effect of paraspinal muscle fatigue on the ability to sense a change in lumbar position . SUMMARY OF BACKGROUND DATA Protection against spinal injury requires proper anticipation of events , appropriate sensation of body position , and reasonable muscular responses . Lumbar fatigue is known to delay lumbar muscle responses to sudden loads . It is not known whether the delay is because of failure in the sensation of position , output of the response , or both . METHODS Altogether , 106 subjects ( 57 patients with low back trouble [ 27 men and 30 women ] and 49 healthy control subjects [ 28 men and 21 women ] ) participated in the study . Their ability to sense a change in lumbar position while seated on a special trunk rotation unit was assessed . A motor rotated the seat with an angular velocity of 1 degree per second . The task in the test involved reacting to the perception of lumbar movement ( rotation ) by releasing a button with a finger movement . The test was performed twice , before and immediately after a fatiguing procedure . During the endurance task , the participants performed upper trunk repetitive extensions against a resistance , with a movement amplitude adjusted between 25 degrees flexion and 5 degrees extension , until exhaustion . RESULTS Patients with chronic low back trouble had significantly poorer ability than control subjects on the average to sense a change in lumbar position ( P = 0.007 ) , which was noticed before and after the fatiguing procedure . Lumbar fatigue induced significant impairment in the sensation of position change ( P < 0.000001 ) . CONCLUSIONS Lumbar fatigue impairs the ability to sense a change in lumbar position . This feature was found in patients and control subjects , but patients with low back trouble had poorer ability to sense a change in lumbar position than control subjects even when they were not fatigued . There seems to be a period after a fatiguing task during which the available information on lumbar position and its changes is inaccurate Owing to the recent interest in torso stabilization exercises together with many questions regarding the duration of prolonged isometric holds in occupational setting s , the authors attempted to assess the level of back muscle oxygenation during prolonged isometric contractions . Specifically , this study recorded relative oxygen saturation of haemoglobin/myoglobin using Near Infrared Spectroscopy ( NIRS ) in the L3 erector mass during prolonged isometric contractions at intensities from 2 to 30 % of maximum voluntary contraction ( MVC ) . It was hypothesized that available oxygen to these muscles is severely compromised even at moderate levels of activation observed in occupational work . Eight volunteers without a history of lower back pain or injury participated in this study . The exercise task involved isometric contraction of the lower erector spinae at five different levels of each subject 's maximal voluntary contraction : 2 , 5 , 10 , 20 and 30 % MVC , presented in r and om order . Subjects were placed in a sitting position , with a curved plastic plate secured horizontally to the pelvis to minimize movement at the hip joint . During extensor exertions , they were restrained with a harness that was attached at chest level to a load cell . Each isometric contraction was performed for 30 s followed by 1 min of rest . All levels of contraction demonstrated reduction in oxygen . Given the concern for motion artefact on the NIRS signal , sham trials were conducted where the subjects went through the procedure of attaching the pulling cable but no active pull was performed . These trials showed no change in the NIRS signal . At this time NIRS appears to be the only non-invasive instrumentation available to indicate total available muscle oxygen during low level , prolonged work . Although the specific tissue volume sample d by NIRS can not be positively identified , it appears that tissue oxygenation in the lumbar extensor musculature is reduced as a function of contraction intensity , even at levels as low as 2 % of MVC . These data have implication s for prolonged work where postures requiring isometric contractions are sometimes held for hours , and where musculoskeletal illness has been linked to prolonged contraction levels above 2 % MVC — these data suggest a possible biological pathway Exposure to whole-body vibration is implicated as one of the occupational risk factors for lower back disorders ; however , its influence on the lumbar muscle physiology is still poorly understood . The objective of this study was to investigate the effects of backrest support and h and grip contractions on lumbar muscle oxygenation and blood volume responses during seated whole-body vibration using continuous dual-wave near-infrared spectroscopy . Thirteen healthy men were exposed to frequencies of 3 , 4.5 and 6 Hz on a vibration simulator , in r and omized order on separate days . Each day the duration of the protocol was 30 min . During the fifth minute of vibration ' with ' and ' without ' backrest support , participants performed maximal rhythmic h and grip contractions for 1 min . In general , erector spinae oxygenation and blood volume showed a trend to decrease with vibration exposure compared to the control condition . However , these responses were not influenced by the change in vibration frequency ( P > 0.05 ) . Sitting without backrest result ed in a greater decrease in oxygenation ( by 27 % , P = 0.02 ) and blood volume ( by 11 % , P = 0.05 ) than with backrest , implying a deficiency in oxygen supply owing to the sitting posture . Compared to the vibration-only condition , h and grip work decreased both oxygenation ( by 22 % , P = 0.003 ) and blood volume responses ( by 13 % , P = 0.04 ) , suggesting that postural load due to prolonged sitting combined with physical activity during vibration might further burden paraspinal muscles . The influence of adipose tissue thickness of the lumbar muscle on optically derived oxygenation and blood volume changes was inconclusive An experiment is described in which two independent groups of eight subjects each performed a combined continuous and discrete tracking task during exposure to vertical whole-body vibration . Both groups received sinusoidal and r and om vibration at preferred third-octave centre frequencies of 0.5 - 10 Hz . One group performed the task with the display collimated by a convex lens . Without the collimation , performance was disrupted by both types of vibration at all vibration frequencies ; collimation removed the disruption at frequencies above 1.6 Hz . There were differences in the effects of r and om and sinusoidal vibration at 2.0 and 2.5 Hz , suggesting that compensatory eye movements were assisting performance during exposure to the predictable sinusoidal motion . The results show that continuous control performance was disrupted by visual interference at frequencies above 1.6 Hz ; closed-loop system transfer functions showed that visual interference increased the phase lags which impaired control performance . Possible mechan \n Output:\n " }, { "from": "agent", "value": "Discussion Given the inconsistency in the reported responses , the precise changes to human function remain unknown .\nHowever , there is sufficient evidence to warrant the design of studies which investigate occupationally relevant physical performance changes following WBV" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To vali date and refine two sets of c and i date criteria for the classification/diagnosis of axial spondyloarthritis ( SpA ) . Methods : All Assessment of SpondyloArthritis international Society ( ASAS ) members were invited to include consecutively new patients with chronic ( ⩾3 months ) back pain of unknown origin that began before 45 years of age . The c and i date criteria were first tested in the entire cohort of 649 patients from 25 centres , and then refined in a r and om selection of 40 % of cases and thereafter vali date d in the remaining 60 % . Results : Upon diagnostic work-up , axial SpA was diagnosed in 60.2 % of the cohort . Of these , 70 % did not fulfil modified New York criteria and , therefore , were classified as having “ non-radiographic ” axial SpA. Refinement of the c and i date criteria result ed in new ASAS classification criteria that are defined as : the presence of sacroiliitis by radiography or by magnetic resonance imaging ( MRI ) plus at least one SpA feature ( “ imaging arm ” ) or the presence of HLA-B27 plus at least two SpA features ( “ clinical arm ” ) . The sensitivity and specificity of the entire set of the new criteria were 82.9 % and 84.4 % , and for the imaging arm alone 66.2 % and 97.3 % , respectively . The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI ( sensitivity 85.1 % , specificity 65.1 % ) and slightly better than that of the modified Amor criteria ( sensitivity 82.9 , specificity 77.5 % ) . Conclusion : The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain . Trial registration number : NCT00328068 Study Design . In 151 adult patients with ankylosing spondylitis who participated in an inpatient rehabilitation program of 3–4 weeks , 10 different range of motion ( ROM ) values were measured , and their lumbar spine and sacroiliac joints were radiographed . Objectives . To determine whether a correlation obtained between restriction of ROM and progression of radiologic findings in ankylosing spondylitis , together with a high enough reliability level in measurements . Summary of Background Data . A significant correlation was observed between the restriction of eight ROMs : the Schober test , thoracolumbar rotation , thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , chest expansion , finger-floor distance , and overall radiologic changes in both lumbar spine and sacroiliac joints ; straight leg raise did not correlate , and vital capacity only with sacroiliac joint changes . Spearman 's correlation coefficients for ROMs were slightly higher to lumbar spine changes than to sacroiliac joint changes . A corresponding correlation was also observed between spinal mobility restrictions and six detailed changes in lumbar roentgenogram : syndesmophytes , apophyseal arthritis , sclerotic anterior borders of vertebrae , straightened anterior surface of vertebrae , and ossification of interspinous and anterior longitudinal ligaments . Other detailed lumbar spine findings did not correlate . As assessed by erythrocyte sedimentation rate values the disease activity increased in the course of radiologic progression , decreasing again , however , to the end stage . Methods . Conventional methods with a tape and ( Myrin ) inclinometer were used to measure thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , finger-floor distance , chest expansion , vital capacity , and straight leg raise . In addition , a new method of thoracolumbar rotation and a new modification of the Schober test were introduced . Thirty-nine patients were r and omized for a reliability assessment using repeated measurements of ROMs . Radiologic changes were evaluated ( in a masked fashion ) using the method of Dale and Vinje . Results . The reliability of all ROMs was good ( except for interraler intraclass correlation coefficients of chest expansion : 0.53 ) . Conclusions : The clear correlation between radiologic sacroiliac joint and lumbar spine progression and eight ROMs showed that these are useful noninvasive measurements of disease progression and severity in ankylosing spondylitis that can be used in daily practice OBJECTIVE To evaluate a magnetic resonance imaging ( MRI ) scoring system for the assessment of spinal inflammation in patients with ankylosing spondylitis ( AS ) who participated in a r and omized , placebo-controlled trial of infliximab , and to examine whether infliximab is also effective for the reduction of MRI-proven spinal inflammation . METHODS Twenty patients with AS ( 9 women and 11 men , mean age 40.9 years ) were examined at baseline and after 3 months . Nine patients had received infusions of infliximab ( 5 mg/kg body weight ) at weeks 0 , 2 , and 6 , and 11 patients had received placebo . Three MRI sequences and 2 scoring systems were used . Chronic lesions were evaluated by T1-weighted turbo spin-echo ( TSE ) sequences and were assigned a chronicity score . Active lesions were evaluated either by repetition of T1-weighted TSE sequences after infusion of gadolinium-diethylenetriaminepentaacetic acid ( Gd-DTPA ) or by short tau inversion recovery ( STIR ) sequences , and were assigned an activity score . The 40 images were evaluated twice by 2 readers who were blinded to the names of the patients and the date s of the examinations , and were analyzed in relation to the clinical results . RESULTS Active spinal lesions were detected in 15 of 20 patients ( 75 % ) ; the frequency as determined by STIR was equal in the 2 groups . At baseline , the total MRI scores determined using Gd-DTPA , STIR , and T1 were 112.5 , 156 , and 253.5 , respectively . The interrater variance and intrarater variance were , respectively , 6.4 and 7.7 for the active lesion score as determined by Gd-DTPA , 15.7 and 5.3 for the active lesion score as determined by STIR sequence , and 167.3 and 75.5 for the chronic lesion score as determined by T1 sequence . Based on the means of the scores assigned by the 2 readers , the active lesion score as determined by Gd-DTPA improved by 40 % in the infliximab group compared with 6 % in the placebo group , the active lesion score as determined by STIR improved by 60 % in the infliximab group but deteriorated by 21 % in the placebo group , and the chronic lesion score as determined by T1 improved by 7 % in the infliximab group but worsened by 35 % in the placebo group . Five patients in the infliximab group and 2 in the placebo group were clinical responders . The acute MRI changes correlated with clinical improvement as assessed by the Bath Ankylosing Spondylitis Disease Activity Index . CONCLUSION This novel MRI scoring system performed well in assessing acute inflammation by using STIR and post-Gd-DTPA sequences . In correlation with clinical improvement in patients with active AS who were treated with infliximab , significant regression of spinal inflammation was shown by using the MRI activity scores OBJECTIVE To develop a reproducible and simple radiologic scoring system for the spine in patients with ankylosing spondylitis ( AS ) : the Bath Ankylosing Spondylitis Radiology Index for the spine ( BASRI-s ) . METHODS Radiographs of 470 patients with AS were scored using the New York criteria for the sacroiliac joints and , similarly , grading the lumbar and cervical spine on a scale of 0 - 4 ( for normal , suspicious , mild , moderate , and severe ) . These 3 scores were added together to produce the BASRI-s score ( scored 2 - 12 ) . Radiographs of 188 patients were used to test reproducibility . Blinded radiographs of 89 non-AS patients were included , r and omly , to assess disease specificity . Sensitivity to change was assessed using 177 radiographs from 58 AS patients . RESULTS Intra- and interobserver variation showed 75 - 86 % and 73 - 79 % complete agreement at all sites , respectively . Specificities of 0.83 - 0.89 suggested that the lumbar and cervical spine BASRI scores were disease specific . Sensitivity to change became apparent at 2 years ( P < 0.001 ) . Using a lateral view and an anteroposterior view of the lumbar spine was more sensitive than using a lateral view alone . Grading a set of radiographs ( sacroiliac joints , lumbar spine , and cervical spine ) took 30 seconds . CONCLUSION BASRI is a reliable method for grading radiographic changes in patients with AS . It is disease specific , sensitive to change , valid , simple , and rapid to perform OBJECTIVE To evaluate the role of MRI in predicting a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) improvement of at least 50 % ( BASDAI 50 ) upon anti-tumour necrosis factor ( TNF ) therapy of active ankylosing spondylitis ( AS ) . METHODS MRIs from patients with active AS who participated in r and omised controlled trials were analysed with respect to presence and extent of active inflammatory lesions as detected in the spine ( n = 46 ) , sacroiliac ( SI ) joints ( n = 42 ) and both sites ( n = 26 ) . Univariate and multivariate logistic regression analyses were applied to evaluate MRI and clinical data in predicting a BASDAI 50 response . RESULTS The Berlin MRI spine score ( odds ratio ( OR ) 1.16 , 95 % CI 1.02 to 1.33 ) and disease duration ( OR 0.9 , 95 % CI 0.63 to 0.97 ) were statistically significant predictors of a BASDAI 50 response using regression analysis while there was only a trend for C-reactive protein ( CRP ) . The likelihood ratio ( LR ) for achievement of BASDAI 50 was increased in patients with a Berlin MRI spine score > /=11 ( LR 6.7 ) , disease duration < 10 years ( LR 4.2 ) and CRP > /=40 mg/litre ( LR 3.4 ) . All patients with two or three of these predictors improved clinical ly ( as assessed by BASDAI ) by at least 45 % . Disease duration > 20 years , normal CRP and no active inflammatory lesion in the spine were highly predictive of not achieving BASDAI 50 . A trend was only found for the MRI score of SI joints to be predictive . CONCLUSIONS Widespread inflammation in the spine as detected by MRI contributes to predicting a BASDAI 50 response in active patients with AS treated with anti-TNF agents Objective To study the relationship between spinal mobility , radiographic damage of the spine and spinal inflammation as assessed by MRI in patients with ankylosing spondylitis ( AS ) . Methods In this sub analysis of the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy cohort , 214 patients , representing an 80 % r and om sample , were investigated . Only baseline data were used . MRI inflammation was assessed by the AS spinal MRI activity ( ASspiMRI-a ) score , structural damage by the modified Stoke AS Spine Score ( mSASSS ) and spinal mobility by the linear definition of the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) . Univariate correlations were calculated on baseline values using Spearman rank correlation . Independent associations between the variables of interest were investigated by multivariate linear regression analysis . Associations with clinical disease activity , C-reactive protein , disease duration , age , gender , body mass index and HLA-B27 status were also investigated . Subanalyses were performed according to disease duration . Results BASMI correlated moderately well with mSASSS ( Spearman 's ρ=0.6 ) and weakly with ASspiMRI-a ( ρ=0.3 ) . A best-fit model for BASMI included both mSASSS ( regression coefficient (B)=0.865 , p<0.001 ) and ASspiMRI-a ( B=0.236 , p=0.018 ) . In patients with a disease duration ≤3 years , B was greater for ASspiMRI-a than for mSASSS ( 0.595 vs 0.380 ) , while in patients with a disease duration > 3 years B was greater for mSASSS than for ASspiMRI-a ( 0.924 vs 0.156 ) . Conclusion Spinal mobility impairment in AS is independently determined both by irreversible spinal damage and by reversible spinal inflammation . Spinal mobility impairment is more influenced by spinal inflammation in early disease , and by structural damage in later disease Study Design . A prospect i ve , controlled clinical study performed in a tertiary care center . Objective . To determine reliability and validity of low-tech measurements in assessment of range of motion ( ROM ) of lumbar flexion in ankylosing spondylitis ( AS ) . Summary of Background Data . ROM measurements of lumbar flexion in patients with AS and healthy subjects are evaluated using original Schober test ( OST ) , modified Schober index ( MSI ) , and modified-modified Schober test ( MMST ) and compared with radiography . Methods . Fifty patients with AS and \n Output:\n " }, { "from": "agent", "value": "Spinal mobility measures do not reflect levels of inflammation at either the sacroiliac joints and /or the spine" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Continuous infusion of levodopa-carbidopa intestinal gel ( LCIG ) can effectively manage motor and non-motor complications in advanced Parkinson 's disease ( PD ) . Healthcare costs , quality of life ( QoL ) , effectiveness , and tolerability were assessed in routine care treatment with LCIG . METHODS The seventy-seven patients enrolled in this prospect i ve , open-label , 3-year study in routine medical care were LCIG-naïve ( N = 37 ) , or had previous LCIG treatment for < 2 ( N = 22 ) , or ≥2 ( N = 18 ) years . Healthcare costs were collected monthly . PD symptoms and QoL were assessed with the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , 39-item Parkinson 's Disease Question naire ( PDQ-39 ) , and EuroQoL 5-Dimension Visual Analog Scale ( EQ-5D VAS ) ; LCIG dose , safety , and tolerability were monitored . RESULTS Mean monthly costs per patient ( € 8226 ± 5952 ) were similar across cohorts , remained steady during 3-year follow-up , and increased with PD severity and QoL impairment . In LCIG-naïve patients , significant improvements compared to baseline were observed on the UPDRS total score and PDQ-39 summary index score through 18 months ( n = 24 ; UPDRS , p = 0.033 ; PDQ-39 , p = 0.049 ) . Symptom control was maintained during 3-year follow-up in LCIG-experienced cohorts . Small changes in mean daily LCIG dose were observed . Adverse events were common and generally related to the device , procedure , levodopa , or laboratory evaluations . CONCLUSIONS Costs in LCIG-treated patients were stable over 3 years . LCIG treatment led to significant improvements in motor function and QoL over 18 months in LCIG-naïve patients and no worsening was observed in LCIG-experienced patients over 3 years despite natural PD progression over time . The long-term safety was consistent with the established LCIG profile Motor complications in Parkinson 's disease ( PD ) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation . l-dopa-carbidopa intestinal gel ( LCIG ) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube ( PEG-J ) , which reduces l-dopa-plasma – level fluctuations and can translate to reduced motor complications . We present final results of the largest international , prospect i ve , 54-week , open-label LCIG study . PD patients with severe motor fluctuations ( > 3 h/day “ off ” time ) despite optimized therapy received LCIG monotherapy . Additional PD medications were allowed > 28 days post-LCIG initiation . Safety was the primary endpoint measured through adverse events ( AEs ) , device complications , and number of completers . Secondary endpoints included diary-assessed off time , “ on ” time with/without troublesome dyskinesia , UPDRS , and health-related quality -of-life ( HRQoL ) outcomes . Of 354 enrolled patients , 324 ( 91.5 % ) received PEG-J and 272 ( 76.8 % ) completed the study . Most AEs were mild/moderate and transient ; complication of device insertion ( 34.9 % ) was the most common . Twenty-seven ( 7.6 % ) patients withdrew because of AEs . Serious AEs occurred in 105 ( 32.4 % ) , most commonly complication of device insertion ( 6.5 % ) . Mean daily off time decreased by 4.4 h/65.6 % ( P < 0.001 ) . On time without troublesome dyskinesia increased by 4.8 h/62.9 % ( P < 0.001 ) ; on time with troublesome dyskinesia decreased by 0.4 h/22.5 % ( P = 0.023 ) . Improvements persisted from week 4 through study completion . UPDRS and HRQoL outcomes were also improved throughout . In the advanced PD population , LCIG 's safety profile consisted primarily of AEs associated with the device/procedure , l-dopa/carbidopa , and advanced PD . LCIG was generally well tolerated and demonstrated clinical ly significant improvements in motor function , daily activities , and HRQoL sustained over 54 weeks . © 2014 The Authors . Movement Disorders published by Wiley Periodicals , Inc. on behalf of International Parkinson and Movement Disorder Society Objectives : To compare daytime intraduodenal levodopa/carbidopa infusion as monotherapy with individually optimized conventional combination therapies in patients with advanced Parkinson disease ( PD ) for motor fluctuations and quality of life ( QoL ) . Methods : Twenty-four patients with motor fluctuations and dyskinesia were studied in a r and omized crossover design to compare individualized conventional treatment and intraduodenal infusion of a levodopa/carbidopa gel for 3 + 3 weeks . Video scoring of motor function was assessed by blinded assessors on a global Treatment Response Scale from −3 to 0 to + 3 ( from severe “ off ” to “ on ” to “ on ” with severe dyskinesia ) . Patient self- assessment of motor performance and QoL was done using an electronic diary . Results : Median percentage of ratings in a functional “ on ” interval ( −1 to + 1 ) was increased from 81 to 100 % by infusion therapy ( p < 0.01 ) . This improvement was accompanied by a decrease in “ off ” state ( p < 0.01 ) and no increase in dyskinesia . Median Unified Parkinson 's Disease Rating Scale score decreased from 53 to 35 in favor of infusion ( p < 0.05 ) . QoL was improved , using the two instruments : Parkinson 's Disease Question naire-39 and 15D Quality of Life Instrument ( p < 0.01 ) . Adverse events were similar for both treatment strategies . Conclusions : Continuous intraduodenal infusion of the levodopa/carbidopa enteral gel as monotherapy is safe and clinical ly superior to a number of individually optimized combinations of conventional oral and subcutaneous medications in patients with motor fluctuations . Intraduodenal infusion of levodopa offers an important alternative in treating patients with advanced Parkinson disease In a double-blind , double-dummy , double-titration Phase 3 trial in advanced Parkinson ’s disease ( PD ) patients , the efficacy and safety of Levodopa-carbidopa intestinal gel ( LCIG ) infusion were characterized relative to immediate-release oral levodopa-carbidopa ( LC-oral ) treatment . We present in this report the comparative pharmacokinetic profiles of LCIG and LC-oral from this pivotal study . The results presented in this report clearly demonstrate that LCIG results in lower variability and fluctuations in levodopa and carbidopa plasma concentrations compared to LC-oral . The superior pharmacokinetic profiles with LCIG were consistent with its improved efficacy compared to LC-oral as demonstrated in this study Objective : The purpose of this work was to identify and estimate a population pharmacokinetic- pharmacodynamic model for duodenal infusion of a levodopa/carbidopa gel ( Duodopa ) to examine pharmacological properties of this treatment . Methods : The modeling involved pooling data from 3 studies ( on advanced Parkinson disease ) and fixing some parameters to values found in literature . The first study involved 12 patients studied on 3 occasions each and was previously published . The second study involved 3 patients on 2 occasions . A bolus dose was given after a washout during night . Plasma sample s and motor ratings ( clinical assessment of motor function on a 7-point treatment response scale ranging from \" very off \" to \" very hyperkinetic \" ) were collected until the clinical effect returned to baseline . The third study involved 5 patients on 3 occasions receiving 5 different dose levels . Different structural models were evaluated using the nonlinear mixed-effects modeling program NONMEM VI . Population mean parameter values , and interindividual , interoccasion , and residual variabilities were estimated . Results : Absorption of the levodopa/carbidopa gel can be adequately described with first-order absorption with bioavailability and lag time . Estimated population parameter values were a mean absorption time of 28.5 minutes , a lag time of 2.9 minutes , and a bioavailability of 88 % . The pharmacodynamic model for motor ratings had the following population values : a half-life of effect delay of 21 minutes , a concentration at 50 % effect of 1.55 mg/L , an Emax of 2.39 U on the treatment response scale , and a sigmoidicity of the Emax function of 11.6 . Conclusions : For the typical unmedicated subject , it will take 51.4 minutes until the peak levodopa effect is reached after a bolus dose . This delay is , like the magnitude of the effect , highly variable in this patient group . The residual error magnitudes of 20 % for levodopa concentrations and 0.92 U ( SD ) for motor ratings indicate that the models developed provide predictions of a relevant quality . The developed model may be a first step toward model-guided treatment individualization of duodenal infusion of levodopa BACKGROUND Levodopa is the most effective therapy for Parkinson 's disease , but chronic treatment is associated with the development of potentially disabling motor complications . Experimental studies suggest that motor complications are due to non-physiological , intermittent administration of the drug , and can be reduced with continuous delivery . We aim ed to assess efficacy and safety of levodopa-carbidopa intestinal gel delivered continuously through an intrajejunal percutaneous tube . METHODS In our 12-week , r and omised , double-blind , double-dummy , double-titration trial , we enrolled adults ( aged ≥ 30 years ) with advanced Parkinson 's disease and motor complications at 26 centres in Germany , New Zeal and , and the USA . Eligible participants had jejunal placement of a percutaneous gastrojejunostomy tube , and were then r and omly allocated ( 1:1 ) to treatment with immediate-release oral levodopa-carbidopa plus placebo intestinal gel infusion or levodopa-carbidopa intestinal gel infusion plus oral placebo . R and omisation was stratified by site , with a mixed block size of 2 or 4 . The primary endpoint was change from baseline to final visit in motor off-time . We assessed change in motor on-time without troublesome dyskinesia as a prespecified key secondary outcome . We assessed efficacy in a full- analysis set of participants with data for baseline and at least one post-baseline assessment , and imputed missing data with the last observation carried forward approach . We assessed safety in r and omly allocated patients who underwent the percutaneous gastrojejunostomy procedure . This study is registered with Clinical Trials.gov , numbers NCT00660387 and NCT0357994 . FINDINGS From baseline to 12 weeks in the full- analysis set , mean off-time decreased by 4.04 h ( SE 0.65 ) for 35 patients allocated to the levodopa-carbidopa intestinal gel group compared with a decrease of 2.14 h ( 0.66 ) for 31 patients allocated to immediate-release oral levodopa-carbidopa ( difference -1.91 h [ 95 % CI -3.05 to -0.76 ] ; p=0.0015 ) . Mean on-time without troublesome dyskinesia increased by 4.11 h ( SE 0.75 ) in the intestinal gel group and 2.24 h ( 0.76 ) in the immediate-release oral group ( difference 1.86 [ 95 % CI 0.56 to 3.17 ] ; p=0.0059 ) . In the safety analyses 35 ( 95 % ) of 37 patients allocated to the levodopa-carbidopa intestinal gel group had adverse events ( five [ 14 % ] serious ) , as did 34 ( 100 % ) of 34 patients allocated to the immediate-release oral levodopa-carbidopa group ( seven [ 21 % ] serious ) , mainly associated with the percutaneous gastrojejunostomy tube . INTERPRETATION Continuous delivery of levodopa-carbidopa with an intestinal gel offers a promising option for control of advanced Parkinson 's disease with motor complications . Benefits noted with intestinal gel delivery were of a greater magnitude than were those obtained with medical therapies to date , and our study is , to our knowledge , the first demonstration of the benefit of continuous levodopa delivery in a double-blind controlled study . FUNDING AbbVie Introduction Continuous delivery of levodopa – carbidopa intestinal gel ( LCIG ) by percutaneous endoscopic gastrojejunostomy ( PEG-J ) in advanced Parkinson ’s disease ( PD ) patients reduces variability in plasma levels , providing better control of motor fluctuations ( “ on ” and “ off ” states ) . The MONOTREAT study assessed the effect of LCIG on activities of daily living , motor and non-motor symptoms , and quality of life in advanced PD patients . Methods This prospect i ve , observational study included patients with advanced , levodopa-responsive PD with either 2–4 h of “ off ” time or 2 h of dyskinesia daily . Patients received LCIG via PEG-J for 16 h continuously . Effect \n Output:\n " }, { "from": "agent", "value": "Conclusions : Continuous delivery of LCIG may offer a promising option for PD patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Optimal fluid management in patients with acute lung injury is unknown . Diuresis or fluid restriction may improve lung function but could jeopardize extrapulmonary-organ perfusion . METHODS In a r and omized study , we compared a conservative and a liberal strategy of fluid management using explicit protocol s applied for seven days in 1000 patients with acute lung injury . The primary end point was death at 60 days . Secondary end points included the number of ventilator-free days and organ-failure-free days and measures of lung physiology . RESULTS The rate of death at 60 days was 25.5 percent in the conservative- strategy group and 28.4 percent in the liberal- strategy group ( P=0.30 ; 95 percent confidence interval for the difference , -2.6 to 8.4 percent ) . The mean ( + /-SE ) cumulative fluid balance during the first seven days was -136+/-491 ml in the conservative- strategy group and 6992+/-502 ml in the liberal- strategy group ( P<0.001 ) . As compared with the liberal strategy , the conservative strategy improved the oxygenation index ( [ mean airway pressure x the ratio of the fraction of inspired oxygen to the partial pressure of arterial oxygen]x100 ) and the lung injury score and increased the number of ventilator-free days ( 14.6+/-0.5 vs. 12.1+/-0.5 , P<0.001 ) and days not spent in the intensive care unit ( 13.4+/-0.4 vs. 11.2+/-0.4 , P<0.001 ) during the first 28 days but did not increase the incidence or prevalence of shock during the study or the use of dialysis during the first 60 days ( 10 percent vs. 14 percent , P=0.06 ) . CONCLUSIONS Although there was no significant difference in the primary outcome of 60-day mortality , the conservative strategy of fluid management improved lung function and shortened the duration of mechanical ventilation and intensive care without increasing nonpulmonary-organ failures . These results support the use of a conservative strategy of fluid management in patients with acute lung injury . ( Clinical Trials.gov number , NCT00281268 [ Clinical Trials.gov ] . ) BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care Introduction Several studies have shown that goal -directed hemodynamic and fluid optimization may result in improved outcome . However , the methods used were either invasive or had other limitations . The aim of this study was to perform intraoperative goal -directed therapy with a minimally invasive , easy to use device ( FloTrac/Vigileo ) , and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a st and ard management protocol . Methods In this r and omized , controlled trial 60 high-risk patients scheduled for major abdominal surgery were included . Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol ( FloTrac/Vigileo device , GDT-group , n = 30 ) or a st and ard management group ( Control-group , n = 30 ) , based on st and ard monitoring data . Results The median duration of hospital stay was significantly reduced in the GDT-group with 15 ( 12 - 17.75 ) days versus 19 ( 14 - 23.5 ) days ( P = 0.006 ) and fewer patients developed complications than in the Control-group [ 6 patients ( 20 % ) versus 15 patients ( 50 % ) , P = 0.03 ] . The total number of complications was reduced in the GDT-group ( 17 versus 49 complications , P = 0.001 ) . Conclusions In high-risk patients undergoing major abdominal surgery , implementation of an intraoperative goal -directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a st and ard management protocol .Trial Registration Clinical trial registration information : Unique identifier : Background : An individualized fluid optimization strategy , based on maximization of cardiac stroke volume ( SV ) with colloid boluses ( goal ‐directed therapy ) , improves outcome after surgery . Oesophageal Doppler ( OD ) is used for SV maximization in most r and omized studies , but evidence ‐based guidelines for the SV maximization procedure are lacking and variation in SV may influence the indication for fluid administration . We measured beat‐to‐beat OD SV before and after fluid optimization in order to estimate the number of heartbeats for which SV needs to be averaged to provide an acceptable accuracy for goal ‐directed therapy with this technology Objective To test whether fluid responsiveness can be predicted by the respiratory variation in aortic blood flow and /or the flow time corrected for heart rate monitored with esophageal Doppler . Design and setting Prospect i ve study in a 24-bed medical intensive care unit of a university hospital . Patients 38 mechanically ventilated patients with sinus rhythm and without spontaneous breathing activity in whom volume expansion was planned . Interventions The aortic blood flow was measured using an esophageal Doppler monitoring device before and after fluid infusion ( 500 ml NaCl 0.9 % over 10 min ) . The variation in aortic blood flow over a respiratory cycle between its minimal and maximal values was calculated . The flow time was also measured . Measurements and results Aortic blood flow increased by at least 15 % after volume expansion in 20 patients ( defined as responders ) . Before fluid infusion the respiratory variation in aortic flow was higher in responders than in nonresponders ( 28±12 % vs. 12±5 % ) . It significantly decreased after volume expansion ( 18±11 % ) in responders only . A respiratory variation in aortic flow before volume expansion of at least 18 % predicted fluid responsiveness with a sensitivity of 90 % and a specificity of 94 % . Flow time increased with fluid infusion in responders and nonresponders . A flow time corrected for heart rate below 277 ms predicted fluid responsiveness with a sensitivity of 55 % and a specificity of 94 % . The area under the ROC curve generated for variation in aortic blood flow ABF was greater than that generated for flow time . Conclusions The respiratory variation in aortic blood flow reliably predicts fluid responsiveness in patients with sinus rhythm and without breathing activity Introduction Total hip replacement is one of the most commonly performed major orthopaedic operations . Goal -directed therapy ( GDT ) using haemodynamic monitoring has previously demonstrated outcome benefits in high-risk surgical patients under general anaesthesia . GDT has never been formally assessed during regional anaesthesia . Methods Patients undergoing total hip replacement while under regional anaesthesia were r and omised to either the control group ( CTRL ) or the protocol group ( GDT ) . Patients in the GDT group , in addition to st and ard monitoring , were connected to the FloTrac sensor/Vigileo monitor haemodynamic monitoring system , and a GDT protocol was used to maximise the stroke volume and target the oxygen delivery index to > 600 mL/minute/m2 . Results Patients r and omised to the GDT group were given a greater volume of intravenous fluids during the intraoperative period ( means ± st and ard deviation ( SD ) : 6,032 ± 1,388 mL vs. 2,635 ± 346 mL ; P < 0.0001 ) , and more of the GDT patients received dobutamine ( 0 of 20 CTRL patients vs. 11 of 20 GDT patients ; P < 0.0003 ) . The GDT patients also received more blood transfused during the intraoperative period ( means ± SD : 595 ± 316 mL vs. 0 ± 0 mL ; P < 0.0001 ) , although the CTRL group received greater volumes of blood replacement postoperatively ( CTRL patients 658 ± 68 mL vs. GDT patients 198 ± 292 mL ; P < 0.001 ) . Overall blood consumption ( intraoperatively and postoperatively ) was not different between the two groups . There were an increased number of complications in the CTRL group ( 20 of 20 CTRL patients ( 100 % ) vs. 16 of 20 GDT patients ( 80 % ) ; P = 0.05 ) . These outcomes were predominantly due to a difference in minor complications ( 20 of 20 CTRL patients ( 100 % ) vs. 15 of 20 GDT patients ( 75 % ) ; P = 0.047 ) . Conclusions GDT applied during regional anaesthesia in patients undergoing elective total hip replacement changes intraoperative fluid management and may improve patient outcomes by decreasing postoperative complications . Larger trials are required to confirm our findings .Trial registration S RCT Objective To test the hypothesis that , in resuscitated septic shock patients , central venous-to-arterial carbon dioxide difference [ P(cv-a)CO2 ] may serve as a global index of tissue perfusion when the central venous oxygen saturation ( ScvO2 ) goal value has already been reached . Design Prospect i ve observational study . Setting A 22-bed intensive care unit ( ICU ) . Patients After early resuscitation in the emergency unit , 50 consecutive septic shock patients with ScvO2 > 70 % were included immediately after their admission into the ICU ( T0 ) . Patients were separated in Low P(cv-a)CO2 group ( Low gap ; n = 26 ) and High P(cv-a)CO2 group ( High gap ; n = 24 ) according to a threshold of 6 mmHg at T0 . Measurements Measurements were performed every 6 h over 12 h ( T0 , T6 , T12 ) . Results At T0 , there was a significant difference between Low gap patients and High gap patients for cardiac index ( CI ) ( 4.3 ± 1.6 vs. 2.7 ± 0.8 l/min/m² , P < 0.0001 ) but not for ScvO2 values ( 78 ± 5 vs. 75 ± 5 % , P = 0.07 ) . From T0 to T12 , the clearance of lactate was significantly larger for the Low gap group than for the High gap group ( P < 0.05 ) as well as the decrease of SOFA score at T24 ( P < 0.01 ) . At T0 , T6 and T12 , CI and P(cv-a)CO2 values were inversely correlated ( P < 0.0001 ) . Conclusion In ICU-resuscitated patients , targeting only ScvO2 may not be sufficient to guide therapy . When the 70 % ScvO2 goal -value is reached , the presence of a P(cv-a)CO2 larger than 6 mmHg might be a useful tool to identify patients who still remain inadequately resuscitated Organ dysfunction and multiple organ failure are the main causes of prolonged hospital stay after cardiac surgery , which increases re source use and health care costs . Increased levels of oxygen delivery and consumption are associated with improved outcome in different groups of postoperative patients . Cardiac surgical patients are at risk of inadequate perioperative oxygen delivery caused by extracorporeal circulation and limited cardiovascular reserves . The purpose of our study was to test whether increasing oxygen delivery immediately after cardiac surgery would shorten hospital and intensive care unit ( ICU ) stay . Four hundred three elective cardiac surgical patients were enrolled in the study and r and omly assigned to either the control or the protocol group . Goals of the protocol group were to maintain Svo2 > \n Output:\n " }, { "from": "agent", "value": "Goals with moderate quality evidence were sublingual microcirculation flow , the oxygen extraction ratio , cardiac index , cardiac output , and SVC collapsibility index ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract H and washing practice s are persistently suboptimal among healthcare professionals and are also stubbornly resistant to change . The purpose of this quasi-experimental intervention trial was to assess the impact of an intervention to change organizational culture on frequency of staff h and washing ( as measured by counting devices inserted into soap dispensers on four critical care units ) and nosocomial infections associated with methicillin-resistant Staphylococcus aureus ( MRSA ) and vancomycin-resistant enterococci ( VRE ) . All staff in one of two hospitals in the mid-Atlantic region received an intervention with multiple components design ed to change organizational culture ; the second hospital served as a comparison . Over a period of 8 months , 860 567 soap dispensings were recorded , with significant improvements in the study hospital after 6 months of follow-up . Rates of MRSA were not significantly different between the two hospitals , but rates of VRE were significantly reduced in the intervention hospital during implementation OBJECTIVES To assess h and washing frequency according to CDC recommendations ; and to test a simple intervention to increase h and washing compliance , design ed for the unique setting of the ED . METHODS A prospect i ve , observational , before- and -after study design with a convenience sampling technique was used to assess h and washing compliance in the ED of a 742-bed urban , university-affiliated medical center with 65,000 visits annually . Emergency physicians ( EPs ) , registered nurses ( RNs ) , and nurse practitioners ( NPs ) were informed that their patient encounters were being monitored , but the nature of the study was kept confidential . A single observer evaluated individual EPs , RNs , and NPs in one- , two- , or three-hour blocks , recording compliance with CDC h and washing recommendations . After two weeks , brightly colored signs with CDC recommendations for h and washing were posted at all sinks and a copy of a related publication on h and washing by medical personnel was distributed to all staff . H and washing behaviors were again observed . RESULTS A total of 252 situations requiring h and washing were observed , 132 pre-intervention and 120 post-intervention . Total h and washing , h and washing by each staff design ation , and h and washing in each CDC recommendation category -- except h and washing between contacts with different patients --all showed tendencies toward improvement , though none was significant ( p > 0.05 ) . Both the NPs and RNs demonstrated significantly higher adherence to recommended h and washing between patients after the intervention than did the EPs ( 85 % vs 71 % vs 31 % , p < 0.01 and p < 0.05 , respectively ) . CONCLUSION Despite a trend in improvement of compliance with CDC recommendations , h and washing among ED personnel remained unacceptably low BACKGROUND H and hygiene prevents cross infection in hospitals , but compliance with recommended instructions is commonly poor . We attempted to promote h and hygiene by implementing a hospital-wide programme , with special emphasis on bedside , alcohol-based h and disinfection . We measured nosocomial infections in parallel . METHODS We monitored the overall compliance with h and hygiene during routine patient care in a teaching hospital in Geneva , Switzerl and , before and during implementation of a h and -hygiene campaign . Seven hospital-wide observational surveys were done twice yearly from December , 1994 , to December , 1997 . Secondary outcome measures were nosocomial infection rates , attack rates of methicillin-resistant Staphylococcus aureus ( MRSA ) , and consumption of h and rub disinfectant . FINDINGS We observed more than 20,000 opportunities for h and hygiene . Compliance improved progressively from 48 % in 1994 , to 66 % in 1997 ( p<0.001 ) . Although recourse to h and washing with soap and water remained stable , frequency of h and disinfection substantially increased during the study period ( p<0.001 ) . This result was unchanged after adjustment for known risk factors of poor adherence . H and hygiene improved significantly among nurses and nursing assistants , but remained poor among doctors . During the same period , overall nosocomial infection decreased ( prevalence of 16.9 % in 1994 to 9.9 % in 1998 ; p=0.04 ) , MRSA transmission rates decreased ( 2.16 to 0.93 episodes per 10,000 patient-days ; p<0.001 ) , and the consumption of alcohol-based h and rub solution increased from 3.5 to 15.4 L per 1000 patient-days between 1993 and 1998 ( p<0.001 ) . INTERPRETATION The campaign produced a sustained improvement in compliance with h and hygiene , coinciding with a reduction of nosocomial infections and MRSA transmission . The promotion of bedside , antiseptic h and rubs largely contributed to the increase in compliance We tested the effectiveness of specific vs. general infection control interventions in a teaching hospital in Guatemala City . After 3 months of prospect i ve surveillance , we implemented targeted interventions ( i.e. , modification of respiratory tract care and use of a closed urinary catheter drainage system ) , an educational program focused on respiratory intervention , and general interventions ( i.e. , aseptic technique ) . The rate of nosocomial pneumonia , the most common nosocomial infection , decreased from 33 % ( 41 of 123 patients ) before intervention to 16 % ( 21 of 130 patients ) after intervention ( P = .001 ) . Although the frequency of h and washing increased from 5 % to 63 % ( P < .001 ) , the rates of other types of nosocomial infections did not change significantly . The combination of targeted respiratory intervention and an intense , focused educational campaign reduced the rate of nosocomial pneumonia . General improvements in hygiene and h and washing rates , or even implementation of a closed urinary drainage system without focused education , may not be sufficient to reduce infection rates in intensive care units in developing countries OBJECTIVE To determine whether a multimodal intervention could improve adherence to h and hygiene and glove use recommendations and decrease the incidence of antimicrobial resistance in different types of healthcare facilities . DESIGN Prospect i ve , observational study performed from October 1 , 1999 , through December 31 , 2002 . We monitored adherence to h and hygiene and glove use recommendations and the incidence of antimicrobial-resistant bacteria among isolates from clinical cultures . We evaluated trends in and predictors for adherence and preferential use of alcohol-based h and rubs , using multivariable analyses . SETTING Three intervention hospitals ( a 660-bed acute and long-term care hospital , a 120-bed community hospital , and a 600-bed public teaching hospital ) and a control hospital ( a 700-bed university teaching hospital).Intervention . At the intervention hospitals , we introduced or increased the availability of alcohol-based h and rub , initiated an interactive education program , and developed a poster campaign ; at the control hospital , we only increased the availability of alcohol-based h and rub . RESULTS We observed 6,948 h and hygiene opportunities . The frequency of h and hygiene performance or glove use significantly increased during the study period at the intervention hospitals but not at the control hospital ; the maximum quarterly frequency of h and hygiene performance or glove use at intervention hospitals ( 74 % , 80 % , and 77 % ) was higher than that at the control hospital ( 59 % ) . By multivariable analysis , preferential use of alcohol-based h and rubs rather than soap and water for h and hygiene was more likely among workers at intervention hospitals compared with nonintervention hospitals ( adjusted odds ratio , 4.6 [ 95 % confidence interval , 3.3 - 6.4 ] ) and more likely among physicians ( adjusted odds ratio , 1.4 [ 95 % confidence interval , 1.2 - 1.8 ] ) than among nurses at intervention hospitals . A significantly reduced incidence of antimicrobial-resistant bacteria among isolates from clinical culture was found at a single intervention hospital , which had the greatest increase in the frequency of h and hygiene performance . CONCLUSIONS During a 3-year period , a multimodal intervention program increased adherence to h and hygiene recommendations , especially to the use of alcohol-based h and rubs . In one hospital , a concomitant reduction was found in the incidence of antimicrobial-resistant bacteria among isolates from clinical cultures Objective Nosocomial infection is an important contributor to morbidity and mortality in pediatric solid organ transplantation . The relative effect of protective gown and glove isolation was compared with strict h and washing in pediatric intensive care unit ( PICU ) patients with solid organ transplantation . Design / Setting A prospect i ve , r and omized design was used ; children in a 23-bed PICU with solid organ transplantation were enrolled into a gown and glove protective isolation protocol or a strict h and washing protocol . Patients All children admitted to the PICU immediately after solid organ transplantation , excluding renal transplantation , and at subsequent readmissions to the PICU were eligible for the study . Children with current infection or known exposure to varicella were excluded from the study initially or at readmission . Interventions By using a block r and omization design based on organ transplanted , age , and initial admission vs. readmission , each patient was r and omized to either strict h and washing or protective gown and glove isolation intervention groups . Measurements We analyzed demographics , infection outcomes ( defined according to Centers for Disease Control criteria ) , and monitoring of patient contacts in compliance with protocol s. Results The infection rate in the overall PICU population did not change significantly from the year before the study compared with during the study ( 2.1 per 100 vs. 1.95 per 100 patient days;p = .4 ) The infection rate in the gown and glove group ( 2.3 per 100 patient days ) was reduced significantly compared with the pre study infection rate in the transplant population ( 4.9 per 100 patient days;p = .0008 ) . Strict h and washing also significantly reduced the infection rate in the transplant population ( 3.0 per 100 patient days;p = .008 ) . Compliance with gowning and gloving was 82 % and compliance with h and washing was 76 % ( compared with 22 % before study [ p < .0001 ] and 52 % after the study [ p < .0001 ] ) . Despite an increased mean length of stay in the PICU in the gown and glove group ( p = .014 ) , there was a trend toward reduction in the incidence of infection ( Fisher ’s exact test , p = .07 ; odds ratio , .76 ) in the gown and glove group . Conclusions Increased compliance with h and washing was associated with a reduction in nosocomial infections , and gown and glove isolation appeared to have an additional protective effect . Some nosocomial infections may be preventable in the pediatric solid organ transplantation population OBJECTIVE To evaluate the effects of a h and hygiene program on compliance with h and hygiene and the rate of nosocomial infections in a neonatal intensive care unit ( NICU ) . DESIGN Open trial . SETTING A level-III NICU in a teaching hospital . PARTICIPANTS Nurses , physicians , and other healthcare workers in the NICU . INTERVENTIONS A multimodal campaign for h and hygiene promotion was conducted beginning in September 1998 . This program consisted of formal lectures , written instructions and posted reminders regarding h and hygiene and proper h and washing techniques , covert observation , financial incentives , and regular group feedback on compliance . Surveillance of h and washing compliance and nosocomial infections before and during the program was analyzed . RESULTS Overall compliance with h and hygiene improved from 43 % at baseline to 80 % during the promotion program . The rate of nosocomial infections decreased from 15.13 to 10.69 per 1,000 patient-days ( P = .003 ) with improved h and washing compliance . In particular , respiratory tract infections decreased from 3.35 to 1.06 per 1,000 patient-days during the h and washing campaign ( P = .002 ) . Furthermore , the correlation between nosocomial infection of the respiratory tract and h and washing compliance also reached statistical significance ( r = -0.385 ; P = .014 ) . CONCLUSIONS Improved compliance with h and washing was associated with a significant decrease in overall rates of nosocomial infection and respiratory infections in particular . Washing h and s is a simple , economical , and effective method for preventing nosocomial infections in the NICU OBJECTIVE To evaluate h and hygiene compliance in 2 adult step-down units ( SDUs ) . DESIGN A 6-month ( from March to September 2007 ) , controlled trial comparing 2 SDUs , one with a feedback intervention program ( ie , the intervention unit ) and one without ( ie , the control unit ) . SETTING Two 20-bed SDUs at a tertiary care private hospital . METHODS H and hygiene episodes were measured by electronic recording devices and periodic observational surveys . In the intervention unit , feedback was provided by the SDU nurse manager , who explained twice a week to the healthcare workers the goals and targets for the process measures . RESULTS A total of 117,579 h and h \n Output:\n " }, { "from": "agent", "value": "Conclusions By focussing on determinants of behaviour change , we found hidden and valuable components in HH improvement strategies .\nAddressing only determinants such as knowledge , awareness , action control , and facilitation is not enough to change HH behaviour .\nAddressing combinations of different determinants showed better results ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Radiofrequency ablation ( RFA ) is an endoscopic technique used to eradicate Barrett 's esophagus ( BE ) . However , such ablation can commonly lead to neosquamous epithelium overlying residual BE gl and s not visible by conventional endoscopy and may evade detection on r and om biopsy sample s. OBJECTIVE To demonstrate the capability of endoscopic 3-dimensional optical coherence tomography ( 3D-OCT ) for the identification and characterization of buried gl and s before and after RFA therapy . DESIGN Cross-sectional study . SETTING Single teaching hospital . PATIENTS Twenty-six male and 1 female white patients with BE undergoing RFA treatment . INTERVENTIONS 3D-OCT was performed at the gastroesophageal junction in 18 patients before attaining complete eradication of intestinal metaplasia ( pre-CE-IM group ) and in 16 patients after CE-IM ( post-CE-IM group ) . MAIN OUTCOME MEASUREMENTS Prevalence , size , and location of buried gl and s relative to the squamocolumnar junction . RESULTS 3D-OCT provided an approximately 30 to 60 times larger field of view compared with jumbo and st and ard biopsy and sufficient imaging depth for detecting buried gl and s. Based on 3D-OCT results , buried gl and s were found in 72 % of patients ( 13/18 ) in the pre-CE-IM group and 63 % of patients ( 10/16 ) in the post-CE-IM group . The number ( mean [ st and ard deviation ] ) of buried gl and s per patient in the post-CE-IM group ( 7.1 [ 9.3 ] ) was significantly lower compared with the pre-CE-IM group ( 34.4 [ 44.6 ] ; P = .02 ) . The buried gl and size ( P = .69 ) and distribution ( P = .54 ) were not significantly different before and after CE-IM . LIMITATIONS A single-center , cross-sectional study comparing patients at different time points in treatment . Lack of 1-to-1 coregistered histology for all OCT data sets obtained in vivo . CONCLUSION Buried gl and s were frequently detected with 3D-OCT near the gastroesophageal junction before and after radiofrequency ablation BACKGROUND The optimal management of high- grade dysplasia in patients with Barrett 's esophagus is controversial . The aim of this study was to assess the prevalence of unsuspected carcinoma at esophagectomy in patients with Barrett 's esophagus with high- grade dysplasia after endoscopic surveillance with jumbo biopsy forceps compared with st and ard biopsy forceps . METHODS Twelve patients with high- grade dysplasia in Barrett 's esophagus without gross or microscopic evidence of carcinoma underwent esophagectomy after preoperative endoscopy with 4-quadrant jumbo biopsies at 2-cm intervals . The findings in this group were compared with those in a group of patients with Barrett 's esophagus who underwent esophagectomy for high- grade dysplasia after biopsies obtained at 2-cm intervals with st and ard biopsy forceps . RESULTS Unsuspected cancer was found in 4 of 12 ( 33 % ) patients in the jumbo biopsy group compared with 6 of 16 ( 38 % ) in the st and ard biopsy group ( p = NS ) . All 6 cancers in the st and ard biopsy group were intramucosal , whereas 2 were intramucosal and 2 were submucosal in the jumbo biopsy group . No patients in either group had lymph node metastases . CONCLUSIONS Unsuspected cancer is found frequently in patients with Barrett 's esophagus who are undergoing esophagectomy for high- grade dysplasia despite the use of a rigorous jumbo biopsy protocol . Esophageal resection is still indicated in appropriately selected patients with high- grade dysplasia until better markers of cancer risk are available BACKGROUND Endoscopic optical coherence tomography ( EOCT ) is a high-resolution , cross-sectional tissue-imaging technique that provides microscopic morphologic information . EOCT should detect dysplasia in Barrett 's epithelium , but this has not been established in a prospect i ve blinded study . This study evaluated the accuracy of EOCT for the diagnosis and the exclusion of dysplasia in patients with Barrett 's esophagus . METHODS A 2.4-mm diameter EOCT probe was modified for use with a cap-fitted , two-channel endoscope . Pairs of EOCT image streams and jumbo biopsy specimens were obtained . Endoscopy/EOCT procedures were performed by 4 endoscopists who separately review ed the EOCT digital images for the absence or the presence of dysplasia ( low grade , high grade , or cancer ) for each biopsy specimen obtained . The endoscopists were blinded to the interpretation of the pathology . An experienced pathologist blinded to the endoscopic/EOCT findings evaluated each biopsy for the absence or the presence of dysplasia . The setting of the study was a major academic medical center . Adult patients with documented Barrett 's esophagus greater than 2 cm were included in the study . The main outcome measurement was the accuracy of EOCT in the detection of dysplasia in patients with Barrett 's esophagus . RESULTS A total of 314 usable EOCT image stream/biopsy pairs were obtained in 33 patients . By using histology as the st and ard , the performance of EOCT was sensitivity , 68 % ; specificity , 82 % ; positive predictive value , 53 % ; negative predictive value , 89 % ; and diagnostic accuracy , 78 % . Diagnostic accuracy for the 4 endoscopists ranged from 56 % to 98 % . Limitations of the study were the variability in endoscopists ' accuracy rates , difficulty in real-time interpretation , and the need for refined criteria of dysplasia by EOCT imaging . CONCLUSIONS The current EOCT system has an accuracy of 78 % for the detection of dysplasia in patients with Barrett 's esophagus . EOCT could be used to target biopsies to areas of Barrett 's epithelium with a higher probability for the presence of dysplasia . However , further modifications , including increased resolution and identification of further potential OCT characteristics of dysplasia , are needed before EOCT can be used clinical ly BACKGROUND & AIMS Radiofrequency ablation ( RFA ) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett 's esophagus ( BE ) , and reduce rates of esophageal adenocarcinoma . We assessed long-term rates of eradication , durability of neosquamous epithelium , disease progression , and safety of RFA in patients with dysplastic BE . METHODS We performed a r and omized trial of 127 subjects with dysplastic BE ; after cross-over subjects were included , 119 received RFA . Subjects were followed for a mean time of 3.05 years ; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years . Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years , durability of response , disease progression , and adverse events . RESULTS After 2 years , 101 of 106 patients had complete eradication of all dysplasia ( 95 % ) and 99 of 106 had eradication of intestinal metaplasia ( 93 % ) . After 2 years , among subjects with initial low- grade dysplasia , all dysplasia was eradicated in 51 of 52 ( 98 % ) and intestinal metaplasia was eradicated in 51 of 52 ( 98 % ) ; among subjects with initial high- grade dysplasia , all dysplasia was eradicated in 50 of 54 ( 93 % ) and intestinal metaplasia was eradicated in 48 of 54 ( 89 % ) . After 3 years , dysplasia was eradicated in 55 of 56 of subjects ( 98 % ) and intestinal metaplasia was eradicated in 51 of 56 ( 91 % ) . Kaplan-Meier analysis showed that dysplasia remained eradicated in > 85 % of patients and intestinal metaplasia in > 75 % , without maintenance RFA . Serious adverse events occurred in 4 of 119 subjects ( 3.4 % ) ; the rate of stricture was 7.6 % . The rate of esophageal adenocarcinoma was 1 per 181 patient-years ( 0.55%/patient-years ) ; there was no cancer-related morbidity or mortality . The annual rate of any neoplastic progression was 1 per 73 patient-years ( 1.37%/patient-years ) . CONCLUSIONS In subjects with dysplastic BE , RFA therapy has an acceptable safety profile , is durable , and is associated with a low rate of disease progression , for up to 3 years BACKGROUND AND STUDY AIMS We studied the feasibility of endoscopic optical coherence tomography imaging in esophageal disorders , including Barrett 's esophagus and Barrett-related adenocarcinoma . Optical coherence tomography is a high-resolution cross-sectional imaging technique with a resolution of almost 10 microm . PATIENTS AND METHODS The mucosal architecture of reflux esophagitis ( n = 9 ) and Barrett 's esophagus ( n = 9 ) including Barrett-related esophageal cancer ( n = 6 ) was studied by optical coherence tomography imaging . RESULTS In different stages of reflux esophagitis edema , fibrinoid deposits , or loss of the epithelial layer were observed . Optical coherence tomography images of Barrett 's esophagus substantially differed from normal esophagus , reflux esophagitis , and esophageal carcinoma . A stratified structure of the mucosa was still preserved in Barrett 's esophagus . However , images of Barrett-related cancer lacked the regular structure of the esophagus . CONCLUSIONS The high consistency of the first optical coherence tomography findings , the resolution of up to 10 microm , and the distinct pattern of normal , inflammatory , premalignant and malignant tissues make optical coherence tomography a promising method for endoscopically obtained optical biopsy BACKGROUND Optical coherence tomography ( OCT ) is a noninvasive technology that can produce high-resolution cross-sectional images in real-time without acoustic coupling , enabling precise assessment of tumor invasion in superficial esophageal squamous cell carcinomas ( SESCCs ) . OBJECTIVE To eluci date the usefulness of in vivo OCT for the staging of SESCCs . DESIGN A single-center , prospect i ve study in 2 phases : phase I to establish the OCT criteria classified into 3 categories ( epithelium or lamina propria mucosa [ EP/LPM ] , muscularis mucosa [ MM ] , submucosa [ SM ] ) and phase II to evaluate these criteria . SETTING An academic medical center . PATIENTS Sixty-two patients with a histological diagnosis of SESCC by routine endoscopy . In the phase I study , 35 images from 16 patients were used . In the phase II study , 109 images from 46 subsequent consecutive patients enrolled from January 2007 to May 2009 were used . INTERVENTIONS We performed OCT for preoperative staging followed by endoscopic submucosal dissection or a surgical procedure and compared precisely the visualized OCT sites with the corresponding tissue sections . MAIN OUTCOME MEASUREMENTS The accuracy of OCT for the staging . RESULTS The overall accuracy rate was 92.7 % ( EP/LPM , 94.9 % ; MM , 85.0 % ; SM , 90.9 % ) . The OCT signal penetration depth was sufficient to depict the boundary of the deepest region of cancer , the thickness of which was less than 1.5 mm . LIMITATIONS The small number of patients . CONCLUSIONS To our knowledge , this is the first study demonstrating that OCT might be useful for the preoperative staging of SESCCs with a high degree of accuracy BACKGROUND AND AIMS The prevalence and clinical relevance of buried Barrett 's gl and s ( BB ) after radiofrequency ablation ( RFA ) in Barrett 's esophagus ( BE ) are debated . Recent optical coherence tomography studies demonstrated a high prevalence of BBs . Direct histological correlation , however , has been lacking . Volumetric laser endomicroscopy ( VLE ) is a second-generation optical coherence tomography system capable of scanning a large surface of the esophageal wall layers with low-power microscopy resolution . The aim was to evaluate whether post-RFA subsquamous gl and ular structures ( SGSs ) , detected with VLE , actually correspond to BBs by pursuing direct histological correlation with VLE images . METHODS In vivo VLE was performed to detect SGSs in patients with endoscopic regression of BE post-RFA . A second in vivo VLE scan was performed to confirm correct delineation of the SGSs . After endoscopic resection , the specimens were imaged ex vivo with VLE . Extensive histological sectioning of SGS areas was performed , and all histology slides were evaluated by an expert BE pathologist . RESULTS Seventeen patients underwent successful in vivo VLE ( histological diagnosis before endos \n Output:\n " }, { "from": "agent", "value": "OCT may identify intestinal metaplasia and dysplasia , but its accuracy may not meet recommended thresholds to replace 4-quadrant biopsies in clinical practice ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Heifer mastitis is a well-known problem , with several pathogens being involved . Several generic risk factors associated with the likelihood of intramammary infections ( IMI ) in fresh dairy heifers have been identified before . Yet , a need exists to identify pathogen group-specific factors , as the effect of ( groups of ) pathogens on udder health and milk yield is different . The aim of the present study was to identify pathogen group-specific risk factors for IMI in heifers participating in a prepartum antimicrobial treatment trial , allowing us to test the hypothesis that different factors are of importance between treated and untreated control heifers as well . Data from a clinical trial in which end-term heifers were treated systemically ( over 3 consecutive days ) 2 wk before calving with penethamate hydriodide ( n=76 ) or remained untreated ( n=73 ) , were available . Several potential risk factors at the herd , heifer , and quarter level were recorded in the first 3 d in milk . Quarters from untreated heifers supplemented with ≥4 mg of selenium/d prepartum were significantly less likely to be infected with coagulase-negative staphylococci ( CNS ) , whereas quarters were more likely to be infected with CNS when assistance during calving was needed . Udder edema before calving significantly decreased the odds of IMI with major pathogens . In treated heifers , no factors were detected that were associated with the likelihood of CNS IMI , whereas quarters from heifers were significantly more likely to be infected with major pathogens when they were housed in the calving pen more than 1 d and when they had been in contact with the lactating cows before calving . The risk factors for IMI that were identified in treated heifers were different than those in untreated heifers , independent of the pathogen group that was considered . It looks as if prepartum treatment not only changed the likelihood of infection , but also the factors that were associated with infection . However , except for treated heifers with an IMI with major pathogens , only a small proportion of the variation could be explained in the final models . Therefore , factors other than those that were studied could explain the likelihood of infection OBJECTIVE To determine whether prepartum intramammary treatment of dairy heifers with pirlimycin hydrochloride would reduce the prevalence of intramammary infection ( IMI ) and lower the somatic cell count ( SCC ) during early lactation or improve 305-day mature equivalent milk production . DESIGN Prospect i ve clinical trial . ANIMALS 183 Holstein-Friesian heifers ( 663 quarters ) from 2 dairy farms . PROCEDURE Heifers were assigned to treatment and control groups . Treated heifers received a single 50-mg dose of pirlimycin in each mammary quarter approximately 10 to 14 days prior to parturition . Prepartum mammary gl and secretions and postpartum milk sample s were collected for bacterial culture . Postpartum milk sample s were also collected for determination of SCC or California mastitis testing and were tested for pirlimycin residues . Mature equivalent 305-day milk production data were recorded . RESULTS Treated heifers in herd A had a higher overall cure rate , higher cure rates for IMI caused by coagulase-negative staphylococci ( CNS ) and Staphylococcus aureus , lower SCC , and lower prevalence of chronic IMI , compared with control heifers . Treated heifers in herd B had a higher overall cure rate and cure rate for IMI caused by CNS , compared with control heifers , but postpartum California mastitis test scores and prevalence of chronic IMI did not differ between groups . Mature equivalent 305-day milk production did not differ between herds or treatment groups . No pirlimycin residues were detected in postpartum milk sample s. CONCLUSIONS AND CLINICAL RELEVANCE Results suggest that prepartum treatment of dairy heifers with pirlimycin may reduce the prevalence of early lactation IMI , particularly IMI caused by CNS , without causing pirlimycin residues in milk Abstract AIMS : The main aim was to investigate the effectiveness of a novel internal teat sealant ( ITS ) formulation containing bismuth subnitrate and the antiseptic chlorhexidine , in adult cows ( Trial A ) and nulliparous heifers ( Trial B ) , to reduce the incidence of new intramammary infection ( IMI ) between treatment and calving and reduce the prevalence of IMI within 6 days following calving . METHODS : In Trial A dairy cows ( n=326 ) without history of clinical mastitis and with a maximum composite milk somatic cell count < 200,000 cells/mL during the current lactation were enrolled from three spring-calving mainly pasture-based herds immediately following the final milking . In Trial B all heifers ( n=166 ) were enrolled from two herds approximately 3 weeks before the start of calving . Gl and s were r and omly assigned to controls or treatment with ITS , and mammary secretion sample s were taken from all gl and s prior to treatment , and on two occasions 0–4 and 3–6 days post-calving to determine the incidence of new IMI and the prevalence of IMI immediately post-calving . Additionally , cows in Trial A were monitored for cases of clinical mastitis ( CM ) in the non-lactating period and animals in both trials were monitored for cases of CM within 30 days of calving . RESULTS : The ITS reduced the estimated incidence of new IMI with both major and any pathogens compared to control gl and s in cows ( 6.2 vs. 14.2 % and 14.7 vs. 32.8 % , respectively ) and in heifers ( 3.0 vs. 13.1 % and 13.4 vs. 25.3 % , respectively ) ( p<0.001 ) . The ITS reduced the estimated prevalence of a major or any pathogen compared to untreated controls at both 0–4 and 3–6 days post-calving , in both cows and heifers . Additionally , the ITS reduced the incidence of CM in the non-lactating period in cows ( −1.0 % , p=0.01 ) and in the 30 days following calving in heifers ( −2.0 % , p=0.06 ) , and tended to reduce the estimated incidence of CM in cows post-calving ( −1.7 % , p=0.10 ) . CONCLUSIONS : The novel ITS reduced the incidence of new IMI , and the prevalence of IMI at calving in both adult cows and heifers , and reduced the incidence of CM in the non-lactating period of cows and in the first 30 days after calving in heifers . CLINICAL RELEVANCE : The results of these trials demonstrate the efficacy of a novel ITS for the control of mastitis in likely uninfected dairy cows over the non-lactating period and in heifers in late pregnancy Abstract AIM : To describe aspects of management of dairy heifers before calving and determine risk factors for clinical mastitis postpartum in heifers , at the herd level , under pasture-based management systems in the Waikato and Taranaki regions of New Zeal and . METHODS : Dairy herdowners ( n=578 ) provided information via a prospect i ve survey about their practice s for rearing heifers and management of mastitis . A proportion of herdowners ( n=250 ) subsequently provided data on the cases of clinical mastitis in their herds , including the date , cow identification , age and quarter affected from cases occurring in the 4 months after the planned start of calving ( PSC ) in the subsequent lactation . The relationship between management factors and the proportion of heifers diagnosed with clinical mastitis within a herd was examined using bivariate and multivariate analyses . RESULTS : The herd average percentage of heifers with clinical mastitis was 13.6 ( 95 % confidence interval (CI)=12.3–14.9)% , and multiparous cows with clinical mastitis was 9.0 ( 95 % CI=8.2–9.8)% in the first 4 months of lactation . There were positive relationships between the proportion of heifers with clinical mastitis and average milk production per cow ( kg milksolids/ lactation ; p<0.001 ) , number of cows milked per labour unit ( p=0.003 ) , stocking rate ( < > 3.30 cows/ha ; p=0.002 ) , and incidence of clinical mastitis in multiparous cows ( % /120 days ; p<0.04 ) , in the final multivariate model . The proportion of heifers with clinical mastitis per herd was lower in herds that milked their lactating cows in multiple groups ( p=0.02 ) . CONCLUSIONS : The risk of clinical mastitis in heifers was significantly associated with management practice s. It may be possible to reduce the incidence of clinical mastitis in heifers by modification of management practice s at the herd level , and further studies are required to investigate this A vaccine was developed against bovine mastitis based on inactivated , highly encapsulated Staphylococcus aureus cells ; a crude extract of Staph . aureus exopolysaccharides ; and inactivated , unencapsulated Staph , aureus and Streptococcus spp . cells . This vaccine was tested on 30 heifers during a 7-mo period . The 30 heifers were r and omly assigned to three groups of 10 heifers each . The prepartum group received two injections of the vaccine at 8 and 4 wk before calving , and the postpartum group received two injections at 1 and 5 wk after calving . The control group received two injections of a placebo at 8 and 4 wk before calving . The vaccine or the placebo was administered subcutaneously in the brachiocephalicus muscle of the neck . The frequencies of intramammary infections caused by Staph . aureus were reduced from 18.8 % for heifers in the control group to 6.7 and 6.0 % for heifers in the prepartum and postpartum groups , respectively . This protective effect was maintained for at least 6 mo . The relative risk of mastitis caused by Staph . aureus was 0.31 and 0.28 for heifers in the prepartum and postpartum groups , respectively , compared with that for heifers in the control group . The results of the trial indicated the effectiveness of the vaccine in decreasing the incidence of intrammammary infections caused by Staph . aureus . A slight but nonsignificant increase occurred in fat production in the milk of vaccinated cows . The vaccine had no observable effect on somatic cell count or streptococcal infections This study investigated the effect in heifers of infusion of a bismuth subnitrate teat-canal sealant and bacterial intramammary infection ( IMI ) precalving on prevalence of postcalving IMI and incidence of clinical mastitis in the first 2 wk postcalving . Gl and s ( n = 1,020 ) from heifers ( n = 255 ) in 5 seasonally calving , pasture-fed dairy herds were r and omly assigned within heifer to 1 of 4 treatment groups ( no treatment ; mammary gl and secretion collection ; infusion of a teat sealant ; or sample collection with infusion of teat sealant ) . Heifers within a herd were enrolled on one calendar day , 31 d on average before the planned start of the seasonal calving period . Duplicate milk sample s were collected from each gl and within 4 d after calving for bacterial culture . Herd owners collected duplicate milk sample s , before treatment , for bacterial culture from gl and s they defined as having clinical mastitis . The gl and prevalence of IMI precalving was 15.5 % and did not differ between herds . Bacteria isolated precalving included coagulase-negative staphylococci ( 76.9 % of all bacteriologically positive sample s ) , Streptococcus uberis ( 14.1 % ) , Staphylococcus aureus ( 5.1 % ) , Corynebacterium spp . ( 3.8 % ) , and others ( 0.1 % ) . The presence of an IMI precalving increased the risk of an IMI postcalving 3.6-fold and the risk of clinical mastitis 4-fold , relative to no IMI precalving . Infusion of the teat sealant reduced the risk of postcalving IMI due to Strep . uberis by 84 % , and of clinical mastitis by 68 % . Sampling the gl and s precalving had no effect on postcalving IMI or on clinical mastitis incidence . Use of an internal teat canal sealant in heifers precalving may be a useful tool for reducing the risk of sub clinical and clinical mastitis in heifers The conduct of r and omized controlled trials in livestock with production , health , and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports . The objective of this project was to modify the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to reflect the unique aspects of reporting these livestock trials . A two-day consensus meeting was held on November 18 - 19 , 2008 in Chicago , IL , United States of America , to achieve the objective . Prior to the meeting , a Web-based survey was conducted to identify issues for discussion . The 24 attendees were biostatisticians , epidemiologists , food-safety research ers , livestock-production specialists , journal editors , assistant editors , and associate editors . Prior to the meeting , the attendees completed a Web-based survey indicating which CONSORT statement items may need to \n Output:\n " }, { "from": "agent", "value": "Although variation was observed in the pathogen-specific effectiveness of treatments at reducing rates of disease , antimicrobials , teat sealants , and combinations of vaccines or teat sealants with antimicrobials were consistently effective , whereas vaccines were only effective for contagious pathogens ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To compare ultrasonic cleaning combined with immersion in a commercially available peroxide-based cleanser solution ( Polident ( ® ) ) with other denture cleaning methods , we examined the quantity of micro-organisms that survived on dentures before and after various cleaning methods . SUBJECTS AND METHODS One hundred complete dentures belonging to 50 nursing home residents ( mean age , 84.6 years ) were r and omly assigned to five groups according to the cleaning method employed : ( A ) immersion in Polident ( ® ) solution alone , ( B ) brushing with water , ( C ) ultrasonic cleaning with water , ( D ) method ( A ) followed by method ( B ) and ( E ) ultrasonic cleaning combined with immersion in Polident ( ® ) solution . Before and after the dentures had been cleaned , denture biofilm was collected from the mucosal surface of each lateral half of the examined dentures . The collected micro-organisms were cultured , presumptively identified by st and ard methods and quantified . Comparisons between the five cleaning methods were carried out using the Kruskal-Wallis test and Dunn 's multiple comparisons test . RESULTS The denture cleaning methods involving the use of Polident ( ® ) solution ( methods A , D and E ) were significantly more effective at denture disinfection than the other methods ( p < 0.05 ) ; in particular , the quantity of C and ida spp . was lowest after method E ( median , 0.00 ; significantly lower than those observed after methods A , B and C ; p < 0.05 ) . CONCLUSION It was concluded that ultrasonic cleaning combined with immersion in a peroxide-based cleanser solution effectively reduces the quantity of micro-organisms surviving on dentures and is a suitable method for elderly individuals who find brushing their dentures difficult PURPOSE To evaluate the effect of disinfection with sodium perborate or chlorhexidine ( when combined with brushing ) on the removal of biofilm in relined dentures . METHODS Swabs were collected 48 hours after the relining procedure and at the follow-up time intervals of 7 , 15 , 30 , 90 , and 180 days . The dentures ' surface roughness was measured at the same times . 45 subjects were r and omly divided into three groups of 15 subjects each . The control group brushed with coconut soap and a soft toothbrush . The sodium perborate group followed the same procedure and also disinfected with sodium perborate solution for 5 minutes per day . The chlorhexidine group followed the control group procedure and disinfected with 2 % chlorhexidine digluconate solution for 5 minutes per day . The number of colony forming units and the surface roughness were evaluated statistically by 2-way repeated-measure ANOVA ( α = 0.05 ) . RESULTS The control group dentures exhibited similar levels of microbial cells throughout the experiment . However , after 15 days , no microbial growth was observed on the dentures for which either disinfection agent was used . There were no statistically significant differences in superficial roughness between the groups ( P = 0.298 ) . The disinfection agents used , combined with brushing , were able to remove the relined dentures ' biofilm after 15 days of disinfection . Roughness was not a predominant factor in CFU reduction BACKGROUND This r and omised clinical study evaluated the effect of chemical disinfection with sodium perborate or chlorhexidine on the colour stability of a hard chairside reline resin during six months . METHODS Hard chairside reline resin ( Tokuyama Rebase Fast II ) was used to reline complete dentures . After baseline colour measurements , the patients were r and omly divided into 3 groups ( n = 15 ) and allocation was concealed with the use of the BioStat program . The dentures were cleansed according to three methods : CG ( control group)--brushing with coconut soap and soft toothbrush , PG ( Perborate group)--brushing according to previous methods and disinfection with warmed sodium perborate solution ( Corega Tabs ) for 5 min , once a day for 6 months and ChxG ( Chlorhexidine Group)--brushing according to CG and disinfection with chlorhexidine digluconate 2 % for 5min once a day for 6 months . The data of ΔE * , ΔL * , Δa * and Δb * were analysed by 2-way repeated- measures ANOVAs and Tukey tests ( α = 0.05 ) . RESULTS There were significant differences amongst groups for ΔL , Δa and Δb . The time had a significant effect on ΔE and ΔL , for all groups evaluated . CONCLUSION Changes in some colour parameters ( ΔL , Δa and Δb ) of the reline resin Tokuyama Rebase were observed when the dentures were disinfected by perborate and chlorhexidine digluconate 2 % solutions . The colour stability of was also influenced by time , regardless of disinfection or nondisinfection . CLINICAL IMPLICATION S Colour stability of the denture material s is one variable to be considered when choosing disinfection methods . The data in this study will be useful to clinicians when they are selecting disinfectant solutions for disinfection of relined denture OBJECTIVE To evaluate the antimicrobial action of effervescent tablets and ultrasound on C and ida spp . and mutans streptococci from denture biofilm . BACKGROUND It is not uncommon for edentulous patients to be elderly and find it difficult to brush their dentures . Hence , auxiliary methods are required for cleansing dentures as well as treating oral infections . MATERIAL S AND METHODS Seventy-seven complete denture wearers were r and omly assigned into four groups : ( A ) Brushing with water ( control ) ; ( B ) Effervescent tablets ; ( C ) Ultrasonic device ( Ultrasonic Cleaner , model 2840 D ) ; ( D ) Effervescent tablets and ultrasonic device . All groups brushed their dentures with a specific brush and water , three times a day , before applying their treatments . Denture biofilm was collected at baseline and after 21 days . The sample s were collected by brushing the dentures with saline and the detached microbial cells were quantified by plating . Counts [ log ( CFU+1 ) ml(-1 ) ] of total aerobes , C and ida spp . and mutans streptococci were compared by one-way anova or Kruskal-Wallis test ( α = 0.05 ) . RESULTS No significant difference was found among the methods from C. albicans ( p = 0.76 ) , C. tropicalis ( p = 0.94 ) and C. glabrata ( p = 0.80 ) . Lower counts were found for methods B and D when compared with the other methods against mutans streptococci ( p < 0.001 ) . Method B showed lower total aerobic counts than A , whereas C and D showed intermediate results ( p = 0.011 ) . CONCLUSION The effervescent tablets significantly reduced mutans streptococci and total aerobes from denture biofilm . However , they was not as effective against C. albicans . Ultrasonic cleansing presented a discrete antimicrobial effect and was less effective than the tablets for complete denture disinfection ABSTRACT To preserve oral health and to maintain the prosthetic devices , it is important not only to improve the properties of commonly known hygiene products , but also to investigate new material s with antimicrobial action . Objectives This study evaluated the antimicrobial activity of sodium hypochlorite ( 0.25 % and 0.50 % ) and 10 % Ricinus communis ’ solutions against specific microorganisms . Material and Methods Sixty four maxillary complete denture wearers were instructed to brush their dentures three times a day and to soak them ( 20 min/day ) in the solutions : SH1 : 0.25 % sodium hypochlorite ; SH2 : 0.5 % sodium hypochlorite ; RC : 10 % R. communis oil ; and C : 0.85 % saline ( control ) . The solutions were used for 7 days in a r and omized sequence . Following each period of use , there was a 1-week washout period . Antimicrobial activity was determined by Colony Forming Units ( CFU ) counts of Streptococcus mutans , C and ida spp . , and gram-negative microorganisms . For collecting biofilm , the internal surface of maxillary dentures was brushed with saline solution , and biofilm suspension obtained . After dilutions ( 100 - 10 - 3 ) , aliquots were seeded in Mitis salivarius , CHROMagar C and ida ® , and MacConkey agar for detecting S. mutans , C and ida spp . , or gram-negative microorganisms , respectively . After incubation , colonies were counted , and CFU/mL values were calculated . Then , transformation - log10 ( CFU+1 ) - data were analyzed using the Friedman test ( α=0.05 ) . Results showed significant differences between the solutions ( p<0.001 ) . Results All three solutions showed antimicrobial activity against S. mutans . Against C and ida spp . , RC and SH1 solutions showed similar effect while SH2 showed superior activity . SH1 and SH2 solutions showed antimicrobial action against gram-negative microorganisms . The C and ida species most frequently isolated was C. albicans , followed by C. tropicalis and C. glabrata . Conclusions The 0.5 % sodium hypochlorite solution was the most effective and might be used to control denture biofilm . C. albicans was the most frequently isolated C and ida PURPOSE To evaluate the effect of microwave disinfection on the color stability of a hard chairside reline resin after a 1-year service period . METHODS 40 adult patients aged between 30 - 75 years , who required denture reline treatment , participated in this study . Tokuyama Rebase II was used to reline complete maxillary dentures . The edentulous subjects were r and omly divided into two groups ( n=20 ) and dentures were cleansed according to two methods : CG ( control group ) - brushing with coconut soap and soft toothbrush ; DG ( disinfection group ) - brushing according to previous methods and microwave disinfection once a week for 3 minutes at 650W . Color parameters in L*a*b * were recorded by spectrophotometer immediately after the reline , at 7 and 15 days , 1 , 3 , 6 and 9 months and 1 year post-placement . Data were analyzed by two-way repeated- measures ANOVA and Tukey tests ( alpha = 0.05 ) . RESULTS Color alteration values of DG were significantly lower than those of CG ( P<0.05 ) . Color changes observed after 15 days were greater than values obtained at 7 days recall ( P<0.05 ) . All color changes observed for the CG were considered noticeable ( between 1.5 and 3.0 NBS ) . In DG , color change was slight ( between 0.5 and 1.5 NBS ) . There were statistically significant differences between L * values obtained initially and after 3 months , between 15 days and 3 months and between 15 days and 1 year ( P<0.05 ) . No significant differences were observed between group and time for the parameters a * and OBJECTIVES This cluster-r and omised controlled trial assessed whether oral health care education ( OHCE ) for nursing home caregivers would achieve improvements in clients ' oral health . METHODS Twenty-two nursing homes were r and omly allocated to intervention or control group . Clients were examined at baseline and at follow-up visits 1- and 6-months after caregivers received OHCE . Main outcome measures were denture plaque , denture-induced stomatitis , dental plaque and gingivitis . Differences in group means/medians were compared with adjustment for cluster r and omisation . RESULTS Clients ' baseline oral health was poor . After OHCE , the intervention group 's oral health scores improved significantly . Reductions in denture plaque scores ( 0 - 4 scale ) exceeded those of the control group by 1.15 ( 95%CI=0.83 , 1.47 ) at 1 month and by 1.47 ( 95%CI=1.13 , 1.80 ) at 6 months . Denture-induced stomatitis prevalence reduced significantly over 6 months compared to the control group ( P<0.0001 ) . Group differences in favour of the intervention group were 0.41 ( 95%CI=0.18 , 0.65 ) at 1 month and 0.34 ( 95%CI=0.14 , 0.53 ) at 6 months for dental plaque ( 0 - 3 scale ) , and 0.17 ( 95%CI= -0.01 , 0.35 ) at 1 month and 0.28 ( 95%CI 0.15 , 0.42 ) at 6 months for gingivitis ( 0 - 2 scale ) . Key differences remained significant after adjustment for clustering effects . The provider 's costs would currently be approximately pounds 6700 per year to deliver the intervention to a Health Authority with 100 homes . CONCLUSIONS Although final levels of residents ' oral health were still short of ideal , this study clearly shows that , for a modest cost , OHCE can improve caregivers ' knowledge , attitudes and oral health care performance for elderly , functionally dependent clients Background Appropriate oral hygiene is required to maintain oral health in denture wearers . This study aims to compare the role of denture cleaning methods in combination with overnight storage conditions on biofilm mass and composition on acrylic removable dentures . Methods In a cross-over r and omized controlled trial in 13 older people , 4 conditions with 2 different mechanical cleaning methods and 2 \n Output:\n " }, { "from": "agent", "value": "Combined application of different hygiene interventions , including brushing or ultrasound vibration in conjunction with chemical agents , leads to more effective outcomes ( reduction in denture biofilm percentage and /or number of microorganisms ' colony-forming units ) .\nCritical concentrations of cleansing solutions along with the duration of their implementation influence the serviceability of dentures regarding colour stability .\nBrushing represents the most commonly applied hygiene practice , while denture wearers ' attitudes are not complied with the recommended guidelines considering the reported frequency of hygiene practice s and the continuous denture wear" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abbreviations ACCORD Action to Control Cardiovascular Risk in Diabetes ADVANCE Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation AGI α-Glucosidase inhibitor CAD Coronary artery disease CKD Chronic kidney disease CVD Cardiovascular disease DPP-4 Dipeptidyl peptidase IV GIP Glucose-dependent insulinotropic peptide GLP-1 Glucagon-like peptide 1 NPH Neutral protamine Hagedorn TZD Thiazolidinedione UKPDS UK Prospect i ve Diabetes Study VADT Veterans Affairs Diabetes Aim : Type II diabetes mellitus ( DM ) increases the risk of cardiovascular disease . Treatment with insulin substantially reduces C - reactive protein ( CRP ) because of its anti-atherosclerotic action . This study was design ed to explore and compare the cardio protective role of regular human insulin ( RHI ) , aspart and lispro insulin in type II DM . Material s and Methods : A r and omized , open , parallel group , comparative clinical study was conducted on 90 patients of type II DM . After baseline clinical assessment and investigations , RHI was prescribed to 30 patients , aspart insulin to 30 patients and lispro insulin to another 30 patients for 12 weeks . The efficacy variables were change in blood pressure , glycemic control , lipid profile , serum potassium , high-sensitivity CRP ( hsCRP ) and UKPDS 10-year CHD risk scoring over 12 weeks . At the end of the study , the patients were followed up and changes in variables from baseline were analyzed by statistical tools . Results : Systolic blood pressure decreased significantly in aspart group ( P = 0.008 ) whereas diastolic blood pressure was decreased significantly both in aspart ( P < 0.001 ) and lispro group ( P = 0.01 ) . Fasting , postpr and ial blood glucose and HbA1c were decreased in all three groups significantly but change in aspart group was superior ( P = 0.01 ) . Triglyceride was significantly better controlled by lispro ( P < 0.01 ) whereas aspart insulin was superior to decrease total cholesterol and LDL ( P < 0.05 ) . The extent of potassium loss was significantly more with RHI ( P = 0.004 ) than others . CRP-lowering effect ( P = 0.017 ) and decrease in UKPDS risk scoring ( P = 0.019 ) in aspart and lispro group was superior to RHI group . Conclusion : Short acting insulin analogues , especially aspart insulin have been found to have a better cardio protective role than RHI in type II DM OBJECTIVE Because there are limited data on the comparison of insulin aspart and mixed insulin in type 2 diabetes , this trial was performed to compare the efficacy and safety of prepr and ial insulin aspart with human soluble insulin ( HI ) and human premix ( 70 % NPH/30 % regular ) insulin ( MIX ) . RESEARCH DESIGN AND METHODS A total of 231 type 2 diabetic patients were r and omized to insulin aspart ( n = 75 ) , HI ( n = 80 ) , or MIX ( n = 76 ) for 3 months . Insulin aspart and HI were administered with or without bedtime NPH insulin . A total of 204 patients completed the trial according to protocol . HbA1c , 7-point blood glucose , insulin dosage , and hypoglycemic episodes were recorded . The primary end point was \" change of HbA1c \" from baseline to last visit . Analysis for equivalence was performed by t tests with three subtests . RESULTS HbA1c decreased 0.91 + /- 1.00 for insulin aspart , 0.73 + /- 0.87 for HI , and 0.65 + /- 1.10 for MIX with the following confidence intervals : insulin aspart HI ( -0.21 to 0.57 , P = 0.025 ) , insulin aspart MIX ( -0.17 to 0.69 , P = 0.092 ) , and HI-MIX ( -0.33 to 0.48 , P = 0.006 ) . Postpr and ial blood glucose decreased in the insulin aspart group : 0.44 mmol/l to > 1.67 mmol/l compared with HI and 1.1 mmol/l to > 1.67 mmol/l compared with MIX . Prepr and ial insulin doses were similar in the insulin aspart and HI groups ( 10 - 14.5 U ) . Hypoglycemic events per month were 0.56 HI , 0.40 insulin aspart , and 0.19 MIX . CONCLUSIONS Statistically , insulin aspart was not equivalent to another treatment in terms of HbA1c reduction . Insulin aspart treatment result ed in improved HbA1c and postpr and ial blood glucose . The application of insulin aspart was safe and well tolerated OBJECTIVE To compare the safety and efficacy of insulin aspart ( IAsp ) , buffered regular insulin ( BR ) , and insulin lispro administered by continuous subcutaneous insulin infusion ( CSII ) in patients with type 1 diabetes . RESEARCH DESIGN AND METHODS After completing a 4-week run-in period with BR , 146 adult patients with type 1 diabetes ( with pretrial CSII experience ) were r and omly assigned ( 2:2:1 ) to CSII treatment with IAsp , BR , or lispro for 16 weeks in a multicenter , open-label , r and omized , parallel-group study . Bolus insulin doses were administered 30 min before meals ( BR ) or immediately before meals ( IAsp or lispro ) . RESULTS Treatment groups had similar baseline HbA(1c ) ( 7.3 % + /- 0.7 for IAsp , 7.5 % + /- 0.8 for BR , and 7.3 % + /- 0.7 for lispro ) . After 16 weeks of treatment , HbA1c values were relatively unchanged from baseline , and the mean changes in baseline HbA1c values were not significantly different between the three groups ( 0.00 + /- 0.51 , 0.15 + /- 0.63 , and 0.18 + /- 0.84 for the IAsp , BR , and lispro groups , respectively ) . The rates of hypoglycemic episodes ( blood glucose < 50 mg/dl ) per patient per month were similar ( 3.7 , 4.8 , and 4.4 for the IAsp , BR , and lispro groups , respectively ) . Clogs/blockages in pumps or infusion sets were infrequent ; most subjects ( 76 , 83 , and 75 % in the IAsp , BR , and lispro groups , respectively ) had < or = 1 clog or blockage per 4 weeks during the trial . CONCLUSIONS Insulin aspart in CSII was as efficacious and well tolerated as BR and lispro and is a suitable insulin for continuous subcutaneous insulin infusion using external pumps BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention . We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes . METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes , using Cox proportional-hazards models with adjustment for covariates measured at baseline and after r and omization . RESULTS During a median follow-up period of 5 years , 231 patients ( 2.1 % ) had at least one severe hypoglycemic episode ; 150 had been assigned to intensive glucose control ( 2.7 % of the 5571 patients in that group ) , and 81 had been assigned to st and ard glucose control ( 1.5 % of the 5569 patients in that group ) . The median times from the onset of severe hypoglycemia to the first major macrovascular event , the first major microvascular event , and death were 1.56 years ( interquartile range , 0.84 to 2.41 ) , 0.99 years ( interquartile range , 0.40 to 2.17 ) , and 1.05 years ( interquartile range , 0.34 to 2.41 ) , respectively . During follow-up , severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events ( hazard ratio , 2.88 ; 95 % confidence interval [ CI ] , 2.01 to 4.12 ) , major microvascular events ( hazard ratio , 1.81 ; 95 % CI , 1.19 to 2.74 ) , death from a cardiovascular cause ( hazard ratio , 2.68 ; 95 % CI , 1.72 to 4.19 ) , and death from any cause ( hazard ratio , 2.69 ; 95 % CI , 1.97 to 3.67 ) ( P<0.001 for all comparisons ) . Similar associations were apparent for a range of nonvascular outcomes , including respiratory , digestive , and skin conditions ( P<0.01 for all comparisons ) . No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death . CONCLUSIONS Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes . It is possible that severe hypoglycemia contributes to adverse outcomes , but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events . ( Funded by Servier and the National Health and Medical Research Council of Australia ; Clinical Trials.gov number , NCT00145925 . ) This r and omized , open-label , cross-over study compares the efficacy of mealtime rapid-acting analog insulin aspart with human insulin , in combination with metformin . A total of 30 patients with type 2 diabetes , inadequately controlled ( HbA(1c)>7.5 % ) with oral hypoglycemic agents ( OHAs ) , were assigned to human insulin 30 min before meals or aspart immediately before meals , both with metformin 500 mg t.i.d . for 90 days . Patients then switched to the alternate insulin . At 90 and 180 days , blood glucose and lipids were measured at baseline and every 30 min after test meals , for 3h . HbA(1c ) and hypoglycemic events were also assessed . After 3 months , HbA(1c ) was significantly reduced with aspart , but not human insulin ( -0.4+/-0.7 % versus + 0.1+/-0.7 % , p<0.05 ) . During meal tests , blood glucose area under the curve ( AUC ) was significantly lower with aspart than human insulin ( 1240+/-476 min/mmol/l versus 1588+/-766 min/mmol/l , p<0.01 ) . AUCs for lipids were similar for both treatments . Neither group experienced serious hypoglycemic events . These results encourage treatment with mealtime insulin aspart plus metformin , in type 2 diabetes patients with postpr and ial hyperglycemia inadequately controlled by OHAs alone Insulin aspart ( IAsp ) , is a rapid-acting analogue of human insulin ( HI ) , for use in the meal related treatment of diabetes mellitus . The degree of glycaemic control achieved by IAsp in comparison with HI after algorithm-driven dose optimisation was tested over 3 months . The prospect i ve , multicentre , r and omised , open-label study with parallel groups was performed in 48 centres in 11 countries and included 423 basal-bolus treated patients with Type 1 diabetes . Main outcome measures were blood glucose control assessed by HbA1c , nine-point self-monitored blood glucose profiles , insulin dose , quality of life , hypoglycaemia and adverse events . An algorithm-driven increase occurred in the dose and number of daily injections of basal insulin , particularly in the IAsp group . After 12 weeks of treatment , HbA1c was significantly lower in IAsp compared to HI treated subjects by 0.17 ( 95 % CI 0.30 - 0.04 ) ( P<0.05 ) . Comparison of the blood glucose profiles showed lower blood glucose levels with IAsp after breakfast ( mean 8.4 vs 10.1 mmol/l ; P<0.0001 ) and dinner ( 8.2 vs 9.3 mmol/l ; P<0.01 ) . There were no differences between treatments in the incidence of hypoglycaemic episodes or in the adverse event profiles . The WHO Diabetes Treatment Satisfaction Question naire score for perceived hyperglycaemia was lower with Iasp ( P=0.005 ) , and patients found the insulin aspart treatment more flexible ( P=0.022 ) . The current study underlines the need for optimising the basal \n Output:\n " }, { "from": "agent", "value": "The risk of overall hypoglycemia and severe adverse effects was comparable between the groups .\nCONCLUSIONS IAsp provides better glycemic control when compared with RHI in patients with T1DM and T2DM .\nFewer T1DM patients treated with IAsp experienced nocturnal hypoglycemia , while both interventions showed a comparable risk of severe hypoglycemic events in both types of diabetes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To prospect ively assess anxiety , depression , coping , and appraisal in female fertility preservation ( FP ) patients compared with infertile patients . DESIGN Prospect i ve pre- and post-treatment survey . SETTING Academic medical center . PATIENT(S ) Forty-seven women with cancer ( FP patients ) and 91 age-matched infertile patients . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Depression , anxiety , coping , infertility-related stress , appraisal of treatment , and medical outcomes . RESULT ( S ) FP patients reported more symptoms of anxiety and depression than infertile patients , but infertile patients ' symptoms worsened over time ; 44 % of FP and 14 % of infertile patients ' scores exceeded the clinical cutoff for depression before treatment . The interval between surveys and medical treatment data did not predict changes in mood symptoms . Coping strategies and infertility-related stress did not differ between groups , and avoidant coping predicted higher depression and anxiety scores . CONCLUSION ( S ) FP patients reported more anxiety and depression than infertile patients at enrollment in treatment , with more than one-third of FP patients reporting clinical ly significant depressive symptoms . However , infertile patients ' anxiety and depressive symptoms increased across treatment . This increase was not related to time between registration for IVF and oocyte retrieval or the medical aspects of treatment . FP and infertile patients should be provided psychologic consultation before treatment to identify mood and anxiety symptoms and to refer patients for counseling as needed to prevent worsening of symptoms PURPOSE This paper reports on a phenomenological study of women 's experiences 1 - 10 years following a radical vaginal trachelectomy and describes the impact on health , sexuality , fertility and perceived supportive care needs . METHOD AND SAMPLE Qualitative telephone interviews employing a descriptive phenomenological approach were conducted using a purposive sample of 12 women . KEY RESULTS Several felt their cancer experience was positive ; bringing them closer to family and changed their outlook on life . A few experienced delayed psychological reactions and /or fears of recurrence . Many experienced isolation and the desire to contact others with similar experiences . Women recovered well but a few experienced fears/concerns about lymphoedema and intermenstrual bleeding . Sexual function was not a long-term issue for most . Some that could feel the cerclage ( stitch ) during intercourse , developed techniques to reduce this . Single women felt vulnerable in new relationships . Pregnancy was an anxious time , especially for those that experienced a miscarriage or pre-term birth . Sources of support included the clinical nurse specialist , family/friends , surgical consultant , online patient forums and a support group . Women needed more information on trachelectomy statistics , pregnancy care recommendations as well as access to counselling , peer support , being seen by the same person and increased public awareness . CONCLUSIONS This study has provided an interesting and detailed insight into women 's experiences in the years following a trachelectomy , with results that have important considerations for practice such as provision of statistical information ; counselling ; peer support ; consistent pregnancy recommendations ; increased public awareness and increased identification and management or prevention of long-term physical effects OBJECTIVE To report the reproductive concerns of women treated for stage I cervical cancer with fertility-preserving surgery . MATERIAL S AND METHODS Newly diagnosed cervical cancer patients undergoing radical trachelectomy were enrolled in this study preoperatively and assessed over time . Preliminary data from the preoperative analysis and 3-month and 6-month assessment points addressing reproductive concerns are presented . RESULTS Between February 2004 and June 2006 , 29 patients were enrolled in the study . Three patients were excluded because they did not undergo the planned surgery and 6 patients were excluded because they required adjuvant therapy . Future childbearing was the main reason most women chose to undergo the procedure ; however , treatment choice was also guided by conversations with their doctors ( 41 % , n=12 ) . Twenty-six ( 90 % ) initially expressed concern over future conception and childbearing , but this increased to all patients by 6 months . At enrollment , the majority of the patients had high expectations for future conception and childbearing but this declined over time . Despite this , patients ' distress gradually decreased over time . CONCLUSIONS Our results show that many women who have undergone a radical trachelectomy present with distress and reproductive concerns that persist for up to 6 months postoperatively . Concerns about conception appear to decrease following surgery ; however , concerns about pregnancy appear to increase post trachelectomy itself . This pilot study reflects the first preliminary data from an active ongoing study prospect ively collecting information over 2 years from newly diagnosed stage I cervical cancer patients undergoing radical trachelectomy OBJECTIVE To prospect ively assess and describe the emotional , sexual , and QOL concerns of women with early-stage cervical cancer undergoing radical surgery . METHODS Seventy-one women who were consented for radical trachelectomy ( RT ) or radical hysterectomy ( RH ) were enrolled preoperatively in this 2-year study ; 52 women ( 33 RT ; 19 RH ) were actively followed . Patients completed self-report surveys composed of 4 empirical measures in addition to exploratory items . Data analyses for the 2 years of prospect i ve data are presented . RESULTS At preoperative assessment , women choosing RH reported greater concern about cancer recurrence ( x=7.27 [ scale from 0 to 10 ] ) than women choosing RT ( x=5.66 ) ( P=0.008 ) . Forty-eight percent undergoing RH compared to 8.6 % undergoing RT reported having adequate \" time to complete childbearing \" ( P<0.001 ) . Both groups demonstrated scores suggestive of depression ( based on the CES-D scale ) and distress ( based on the IES scale ) preoperatively ; over time , however , CES-D and IES scores generally improved . Scores on the Female Sexual Functioning Inventory ( FSFI ) for the total sample were below the mean cut-off ( 26.55 ) , suggestive of sexual dysfunction ; however , the means increased from 16.79 preoperatively to 23.78 by 12 months and 22.20 at 24 months . CONCLUSION Measurements of mood , distress , sexual function , and QOL did not differ significantly by surgical type , and instead reflect the challenges faced by young cervical cancer patients treated by RT or RH without adjuvant treatment . Points of vulnerability were identified in which patients may benefit from preoperative consultation or immediate postoperative support . Overall , patients improved during the first year , reaching a plateau between Year-1 and Year-2 , which may reflect a new level of functioning in survivorship Introduction : To present a qualitative data analysis of items exploring the treatment , adjustment , and recovery of 33 patients who underwent radical trachelectomy ( RT ) , and to determine the feasibility of using a physician checklist ( PCL ) as a model for survivorship assessment . Methods : This prospect i ve study was approved by the Memorial Sloan-Kettering Cancer Center 's Institutional Review Board . Participants completed a survey including exploratory items focused on fertility issues and reproductive concerns , treatment , adjustment , and recovery over 2 years . All responses to the exploratory questions were transcribed verbatim ; thematic analysis was used to identify , evaluate , and show patterns within the data set ; and descriptive statistics were calculated for thematic categories . A limited waiver of authorization was obtained for medical chart review of these patients ( who underwent RT ) for 2years before ( January 2006 to December 2007 ) and 2 years after ( January 2008 to December 2009 ) implementation of the checklist to evaluate its feasibility . Results : In response to \" how successful you feel you will be at conceiving in the future ? \" on a scale of 0 % to 100 % , scores ranged from 54 % to 60 % . Approximately 70 % of the patients reported concerns about conceiving ; however , these lessened with time-88 % at 6months to 73 % at 24 months . Six percent of women were trying to conceive by 12 months ; this increased to 21 % by 24 months . Five primary themes emerged from the qualitative analysis that were found to be prevalent across all exploratory items inquiring about difficulties or the hardest adjustment to treatment , recovery , and problems associated with RT ; these included menstrual/vaginal issues , emotional impact , life interruptions/return to normalcy , general pain , and recovery process . The PCL identified higher rates of neocervical stenosis ( 58 % ) , encroachment ( 54 % ) , vaginal scarring ( 50 % ) , and dyspareunia ( 33 % ) than medical charts , and increased documentation of reproductive consults ( 54 % ) and assistance ( 21 % ) . Conclusion : Global themes expressed by our patients are consistent with those of other cancer survivors . The PCL is an excellent supplement to medical charts by documenting important survivorship issues BACKGROUND Evidence suggests that cancer diagnosed during adolescence and young adulthood may present considerable challenges to what would otherwise be a relatively smooth developmental trajectory , particularly in areas related to reproductive health . We created and pilot tested a two-session , individually-delivered , counseling intervention to enhance psychosexual development in this unique population . PROCEDURES A total of 21 patients , aged 15 to 25 years and treated for cancer within the past 5 years , completed the counseling intervention . Patients were adaptively r and omized to begin the intervention immediately , or to be placed on a 3-month waitlist , after which time , they were reassessed and began the intervention . The content of the intervention included education , dialog , and support regarding cancer and such issues as sexual development and function , body image , fertility , prevention of sexually transmitted disease and unwanted pregnancy , and romantic relationships ( e.g. , dating , sexual communication ) . A 1-month follow-up booster call followed the intervention . Question naires were completed at baseline , post-waitlist ( for half the sample ) , post-treatment , and at 3-month follow-up . RESULTS Participation in the intervention increased cancer-specific knowledge regarding sexual issues ; improved body image ; lessened anxiety about sexual and romantic relationships ; and decreased overall level of psychological distress . Gains were maintained through the 3-month follow-up . CONCLUSIONS Addressing issues of reproductive health in the adolescent/young adult with cancer can and should be offered as a part of comprehensive pediatric cancer care PURPOSE Orchiectomy followed by infradiaphragmatic irradiation is the st and ard treatment for Stage I-II testicular seminoma in The Netherl and s. Because body image and sexual functioning can be affected by treatment , a retrospective study was carried out to assess treatment outcome , body image , and changes in sexuality after orchiectomy and radiotherapy . METHODS AND MATERIAL S The medical charts of 166 patients with Stage I-II testicular seminoma were review ed . A question naire on body image and current sexual functioning regarding the frequency and quality of erections , sexual activity , significance of sex , and changes in sexuality was sent to 157 patients ( at a mean of 51 months after treatment ) . RESULTS Seventy-eight percent ( n = 123 , mean age 42 years ) completed the question naire . During irradiation , almost half of patients experienced nausea and 19 % nausea and vomiting . Only 3 patients had disease relapse . After treatment , about 20 % reported less interest and pleasure in sex and less sexual activity . Interest in sex , erectile difficulties , and satisfaction with sexual life did not differ from age-matched healthy controls . At the time of the survey , 17 % of patients had erectile difficulties , a figure that was significantly higher than before treatment , but which correlated also with age . Twenty percent expressed concerns about fertility , and 52 % found their body had changed after treatment . Cancer treatment had negatively influenced sexual life in 32 % of the patients . CONCLUSIONS Orchiectomy with radiotherapy is an effective and well-tolerated treatment for Stage I-II testicular seminoma . Treatment-induced changes in body image and concerns about fertility were detected , but the sexual problems encountered did not seem to differ from those of healthy controls , although baseline data are lacking \n Output:\n " }, { "from": "agent", "value": "Fertility-related psychological distress persists from diagnosis through to survivorship , with cancer patients reporting a range of negative emotional experiences brought about by threatened infertility .\nIn survivorship , reproductive concerns , unfulfilled desire for a child , nulliparous status , and early menopause were linked to higher rates of mental health disorders and psychological distress .\nCONCLUSIONS Fertility-related psychological distress is prevalent and persistent in cancer patients and survivors .\nAs such , patients and survivors would greatly benefit from fertility-related psychological support implemented into st and ard practice from diagnosis through to survivorship ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose Dacryocystorhinostomy ( DCR ) is widely accepted as the procedure of choice for surgical correction of lacrimal drainage system obstruction distal to common canaliculus in adulthood . The success rate of DCR has been reported to be from 63 % to 99 % . DCR failure has been attributed to membranous occlusion of the rhinostomy site caused by soft tissue scarring . More recently , use of mitomycin C ( MMC ) has been described in lacrimal drainage surgery . The beneficial effect of MMC as a surgical adjunct is thought to be related to its potent inhibition of fibroblast proliferation . Methods To improve the success rate of DCR , the authors used MMC as an adjunct to surgery in 130 patients with nasolacrimal duct obstruction undergoing lacrimal surgery . They were assigned r and omly into a MMC DCR group and a regular DCR group ( control group ) . Results The mean age of the MMC group was 40 ± 15 years and that of the control group was 42 ± 16 years . The st and ard surgical techniques of an external DCR were used in all patients of both groups . Patients were followed for 6 months . The authors evaluated the patients with subjective symptoms ( improvement in tearing ) and objective findings such as the height of tear meniscus , fluorescein dye test , and patency at the time of irrigation . There was no significant difference in the age between the two groups ( p=1.00 ) . Six patients in the mitomycin group were symptomatic after 6 months ' follow-up ; probe and irrigation showed non-patency of lacrimal system . The success rate in the MMC group was therefore 90.5 % ( 59/65 ) , and in the conventional group it was 92.4 % ( 60/65 ) . No significant difference between the two groups was present ( p=0.75 ) . Conclusions The authors conclude that the use of intraoperative MMC in DCR surgery does not change the success rate of this procedure AIMS To evaluate the long term results of intraoperative mitomycin C application in dacryocystorhinostomy ( DCR ) surgery compared with results of the conventional procedure . METHODS In this prospect i ve r and omised controlled study , a total of 88 eyes diagnosed with acquired nasolacrimal duct obstruction were r and omly divided into a conventional DCR group and a mitomycin C group in which mitomycin C was used during DCR surgery . The surgical procedures in both groups were exactly the same , except that in the patients in the mitomycin C group , a piece of neurosurgical cottonoid soaked with 0.2 mg/ml mitomycin C was applied to the osteotomy site for 30 minutes . The results of the DCR surgeries were evaluated by objective findings such as irrigation and the height of tear meniscus and subjective symptoms by asking patients the condition of tearing improvement . RESULTS Among the 44 eyes in the mitomycin C group , 95.5 % of patients remained totally symptom free after 10 months of follow up ; while in the conventional group , 70.5 % of patients were reported to be symptom free and 18 % of patients to have an improvement in their symptoms . There was a significant difference between these two groups . As far as objective findings were concerned , there were 41 eyes in the mitomycin C group classified as having a normal and one eye with moderate tear meniscus level , compared with 32 eyes and seven eyes , respectively , in the conventional group . There was also a significant difference between these two groups . The non-patency rate in the mitomycin C group is 4.5 % compared with 11.4 % in the conventional group . There were no complications such as abnormal nasal bleeding , mucosal necrosis , or infection except one patient with delayed wound healing . CONCLUSIONS Intraoperative mitomycin C application is effective in increasing the success rate of DCR surgery in st and ard nasolacrimal duct obstruction , and no significant complications result ed from its use OBJECTIVES /HYPOTHESIS To evaluate the efficacy of intraoperative mitomycin C ( MMC ) in endonasal endoscopic dacryocystorhinostomy . STUDY DESIGN R and omized controlled trial . METHODS Fifty patients with primary acquired nasolacrimal duct obstruction were enrolled and r and omly allocated into the treatment and control group . The patients underwent st and ard endonasal endoscopic dacryocystorhinostomy with mucosal flaps and mitomycin C or placebo on each group . The ostium size was measured at 3 months , 6 months , and 12 months to evaluate the effect of mitomycin C and placebo , and the patency of the lacrimal drainage system was assessed . RESULTS There was no statistical significance in the success rate between the MMC group and the control group at 1-year follow-up ( 84.6 % vs.79.2 % , respectively , P = .59 ) . At the 6-month and 12-month visits , the mean ostium size in the MMC group was 10.8 mm(2 ) ( SD = 3.17 ) and 3.0 mm(2 ) ( SD = 1.78 ) , respectively , which were prominently larger than the control group at 7.1 mm(2 ) ( SD = 2.62 ; P < .001 , 95 % CI , 0.84 - 5.45 ) and 1.6 mm(2 ) ( SD = 1.18 ; P = .004 , 95 % CI , 0.49 - 2.38 ) . CONCLUSIONS There was no statistically significant difference in the success rates of both groups , but MMC seems to have a conspicuous effect on the healing process at the ostium Objective To assess the long-term results of intraoperative mitomycin C ( MMC ) in external dacryocystorhinostomy ( EXT-DCR ) . Methods In this prospect i ve r and omized controlled study , 35 patients ( 40 eyes ) with primary acquired nasolacrimal duct obstruction were assigned r and omly into two groups . In the control group , a st and ard EXT-DCR procedure was performed . In the MMC group 0.2 mg/ml MMC was applied to the osteotomy site for 30 min . The results of EXT-DCR in both groups were evaluated by both asking patients about the tearing condition and examining the patency of irrigation at one-year follow up . Results Eighteen ( 90 % ) of the 20 eyes in the MMC group remained totally symptom-free and one eye ( 5 % ) improved ; while 12 ( 60 % ) of 20 eyes in the control group were reported to be symptom-free and five ( 25 % ) of the eyes to have an improvement in the tearing symptoms ( P = 0.087 ) . The success rate in the MMC group was 95 % compared with 85 % in the control group ( P = 0.605 ) . No surgical complications occurred . Conclusions The satisfaction and success rates of the MMC group were higher than those of the control group and no deleterious effect was noted with MMC application , however the differences did not reach statistical significance . Intraoperative MMC application seems to be a safe adjuvant that could help in increasing the success rates of EXT-DCR surgery in primary acquired nasolacrimal duct obstruction , however further studies with larger series are needed to make definite statements PURPOSE The purpose of this study is to observe the effect of intraoperative topical application of mitomycin C ( MMC ) on the results of endoscopic dacryocystorhinostomy . DESIGN This is a prospect i ve , r and omized , controlled , single-blind study . SETTING S Hospitalized treatment was done in a tertiary medical college hospital and research center that deals with a predominantly rural population . PATIENTS Patients with primary acquired postsaccal obstruction causing chronic dacryocystitis were considered . METHODS A total of 38 patients were r and omized into either a mitomycin group or a control group . Both of these groups were subjected to an identical surgical procedure , except that 0.2 mg/dL of MMC was used in the mitomycin group , whereas normal saline was used in the control group . The follow-up period was at least 6 months . An asymptomatic patient with a visible stoma at nasendoscopy and free flow of saline into the nose with lacrimal syringing after 6 months after surgery was used as criteria for defining a successful result . RESULTS The success rate was 82.3 % when MMC was used and 85.7 % among the controls ( P > .05 ) . Granulations , adhesions , and obliterative sclerosis occurred in a similar number of patients of both groups . However , granulations and adhesions did not have a bearing on the success rate in either group . CONCLUSION Mitomycin C did not appear to influence the occurrence of granulations , synechiae , or obliterative sclerosis , nor did it alter the success rate significantly Purpose To assess the effect of mitomycin C on surgical success rate of dacryocystorhinostomy and silicone intubation in patients with improper flaps . Methods The study was a r and omized clinical trial . The patients with indication for dacryocystorhinostomy surgery with silicone intubation ( inappropriate lacrimal sac or nasal mucosal flaps during surgery and /or history of dacryocystitis in the past 3 months ) were r and omly assigned to application of mitomycin C ( 0.02 % ) on surgical flaps ( group A ) or a control group without mitomycin C application ( group B ) . Main outcome measures were subjective symptomatic improvement and result of irrigation test at last follow-up visit . Results The study enrolled 88 patients ( 88 eyes ) ; there were 42 patients in group A and 46 patients in group B. There was an average follow-up of 10 months ( range 6 - 15 months ) following surgery . Significant improvement ( no tearing with patent lacrimal system in irrigation ) was observed in 31 patients ( 73.8 % ) in group A and 32 patients ( 69.6 % ) in group B. There was no statistically significant difference in no improvement ( no change in tearing state and obstruction in irrigation test ) , relative improvement ( decreased tearing and passage of fluid with force in irrigation test ) , and significant improvement rate between the 2 groups of study ( p>0.05 ) . Conclusions Application of mitomycin C on surgical flaps during dacryocystorhinostomy surgery with silicone intubation in patients with improper flaps has no proven beneficial effect on success rate of surgery Objective : To evaluate the role of topical Mitomycin C in Endoscopic Dacryocystorhinostomy ( DCR ) , for the prevention of stomal stenosis . Patients : Thirty patients undergoing endoscopic DCR for chronic dacryocystitis were studied prospect ively . The follow up period was 12 months . Technique : Patients were divided into two groups r and omly . All of them underwent endoscopic DCR . One group was subjected to topical Mitomycin C application after surgery while the control group was not . Main outcome measures : Postoperative relief of epiphora and endoscopic documentation of the patency of the stoma were the main outcome measures . Results : 80 % cases of the Mitomycin C group and 86.67 % cases of the non Mitomycin C group had long-term successful results . This result is not statistically significant ( p > 0.2 ) . Conclusion : Intraoperative Mitomycin C application does not alter the long-term results in endoscopic DCR . A properly and adequately performed surgery is more vital for successful result PURPOSE To evaluate the efficacy and safety of adjunctive mitomycin-c ( MMC ) during probing in adults with primary nasolacrimal duct ( NLD ) obstruction . METHODS This is a prospect i ve , comparative , r and omized interventional study . A total of 40 adult patients with unilateral epiphora caused by primary NLD obstruction were treated and evaluated . Lacrimal probing and irrigation with adjunctive MMC ( 1 mL of 0.2 mg/mL , once ) in cases and only probing in controls were done . At the end of 3 months , subjective improvement in epiphora and patency on syringing were evaluated . RESULTS Complete subjective improvement in epiphora was found in 15 % of cases as opposed to 0 % in controls , at 3 months of follow-up . Moderate improvement was seen in 25 % of cases as opposed to 5 % of controls . Mild improvement was seen in 25 % of cases as opposed to 35 % in controls . The overall subjective improvement was seen in 65 % of cases as opposed to 40 % in controls . On syringing , NLD was patent in 30 % of cases as opposed to 10 % in controls at 3 months of follow-up , which was not significant . CONCLUSIONS Use of intraoperative MMC improves the success of probing to some extent . Being a minimally invasive procedure , it can be tried in patients who refuse or are not systemically fit for undergoing dacryocystorhinostomy Aims and objectives To compare the outcome of dacryocystorhinostomy surgery with and without the intraoperative use of Mitomycin C. Methods Our study is a prospect i ve comparative case study in which 50 patients of primary acquired nasolacrimal duct obstruction were divided on the basis of r and om sampling into the conventional dacryocystorhinostomy group and the Mitomycin C group in which Mitomycin C 0.2 mg/ml was used intraoperatively . Patients were followed on 1st postoperative day , 1st , 3rd , 6th weeks , 3rd and 6th months . Patient \n Output:\n " }, { "from": "agent", "value": "The intraoperative use of MMC is safe and slightly improves the success rate of Ex- or En-DCR ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Makhlouf , I , Castagna , C , Manzi , V , Laurencelle , L , Behm , DG , and Chaouachi , A. Effect of sequencing strength and endurance training in young male soccer players . J Strength Cond Res 30(3 ) : 841–850 , 2016—This study examined the effects of strength and endurance training sequence ( strength before or after endurance ) on relevant fitness variables in youth soccer players . Fifty-seven young elite-level male field soccer players ( 13.7 ± 0.5 years ; 164 ± 8.3 cm ; 53.5 ± 8.6 kg ; body fat ; 15.6 ± 3.9 % ) were r and omly assigned to a control ( n = 14 , CG ) and 3 experimental training groups ( twice a week for 12 weeks ) strength before ( SE , n = 15 ) , after ( ES , n = 14 ) or on alternate days ( ASE , n = 14 ) with endurance training . A significant ( p = 0.001 ) intervention main effect was detected . There were only trivial training sequence differences ( ES vs. SE ) for all variables ( p > 0.05 ) . The CG showed large squat 1 repetition maximum ( 1RM ) and medium sprint , change of direction ability , and jump improvements . ASE demonstrated a trivial difference in endurance performance with ES and SE ( p > 0.05 ) . Large to medium greater improvements for SE and ES were reported compared with ASE for sprinting over 10 and 30 m ( p < 0.02 ) . The SE squat 1RM was higher than in ASE ( moderate , p < 0.02 ) . Postintervention differences between ES and SE with CG fitness variables were small to medium ( p ⩽ 0.05 ) except for a large SE advantage with the Yo-Yo intermittent recovery test ( p < 0.001 , large ) . This study showed no effect of intrasession training sequence on soccer fitness-relevant variables . However , combining strength and endurance within a single training session provided superior results vs. training on alternate days . Concurrent training may be considered as an effective and safe training method for the development of the prospect i ve soccer player This study investigated the effects of different intra-session exercise sequences in the cardiovascular and neuromuscular adaptations induced by concurrent training in elderly . Twenty-six healthy elderly men ( 64.7±4.1years ) , were r and omly placed into two concurrent training groups : strength training prior to ( SE , n=13 ) or after ( ES , n=13 ) endurance training . Subjects trained strength and endurance training 3 times per week performing both exercise types in the same training session . The peak oxygen uptake ( VO(2peak ) ) , maximum aerobic workload ( W(máx ) ) , absolute ( VT(1 ) and VT(2 ) ) and relative ( VT(1)% and VT(2)% ) ventilatory thresholds , as well as workloads at VT(1 ) and VT(2 ) ( W(VT1 ) and W(VT2 ) ) were evaluated during a maximal incremental test on a cycle ergometer before and after the training . In addition , muscle quality ( MQ ) was evaluated by the quotient between maximal dynamic strength ( one repetition maximum test ) of the knee extensors and the quadriceps femoris muscle thickness determined by ultrasonography . There were no modifications after training in the VT(1 ) , VT(2 ) , VT(1)% , and VT(2)% . There was significant increase in the W(VT1 ) only in SE ( P<0.05 ) , as well as significant increase in the W(VT2 ) in both groups ( P<0.001 ) . There was significant increase in the VO(2peak ) , with both groups showing increases ( P<0.001 ) , with no difference between groups ; as well significant increase in the W(máx ) ( P<0.001 ) with no difference between SE and ES . The force per unit of muscle mass of knee extensors increased in both groups ( P<0.001 ) , but the increase was significantly higher in SE than in ES ( 27.5±12.7 vs. 15.2±10.3 % , P<0.02 ) . Hence , the intra-session exercise sequence had no influence in the maximal endurance power adaptations to concurrent training , but had influence in the magnitude of the muscle quality enhancements OBJECTIVE To investigate the effects of a 21-week concurrent strength and endurance training protocol on physical fitness profile in women with early or longst and ing rheumatoid arthritis ( RA ) compared with healthy subjects . METHODS Twenty-three female patients with RA volunteered for the study . Twelve had early RA and eleven had longst and ing RA . Twelve healthy women served as controls . Maximal strength of different muscle groups was measured by dynamometers , walking speed with light cells , and vertical squat jump on the force platform to mirror explosive force . Maximal oxygen uptake was measured by gas analyzer . Six training sessions ( 3 strength training and 3 endurance training ) were carried out in a 2-week period for 21 weeks . RESULTS The training led to large gains in maximal strength both in women with RA and in healthy women ( P < 0.043 - 0.001 ) . The strength gains were accompanied by increases in walking speed ( P < 0.034 - 0.001 ) and vertical squat jump ( P < 0.034 - 0.001 ) . Significant improvements also occurred in maximal aerobic capacity in all groups ( P < 0.023 - 0.014 ) . CONCLUSIONS Both early and longst and ing RA patients with stable disease can safely improve all characteristics of their physical fitness profile using a progressive concurrent strength and endurance training protocol This study investigated the effects of different exercise sequences on the neuromuscular adaptations induced by water-based concurrent training in postmenopausal women . Twenty-one healthy postmenopausal women ( 57.14 ± 2.43 years ) were r and omly placed into two water-based concurrent training groups : resistance training prior to ( RA , n = 10 ) or after ( AR , n = 11 ) aerobic training . Subjects performed resistance and aerobic training twice a week over 12 weeks , performing both exercise types in the same training session . Upper ( elbow flexors ) and lower-body ( knee extensors ) one-repetition maximal test ( 1RM ) and peak torque ( PT ) ( knee extensors ) were evaluated . The muscle thickness ( MT ) of upper ( biceps brachii ) and lower-body ( vastus lateralis ) was determined by ultrasonography . Moreover , the maximal and submaximal ( neuromuscular economy ) electromyographic activity ( EMG ) of lower-body ( vastus lateralis and rectus femoris ) was measured . Both RA and AR groups increased the upper- and lower-body 1RM and PT , while the lower-body 1RM increases observed in the RA was greater than AR ( 34.62 ± 13.51 vs. 14.16 ± 13.68 % ) . RA and AR showed similar MT increases in upper- and lower-body muscles evaluated . In addition , significant improvements in the maximal and submaximal EMG of lower-body muscles in both RA and AR were found , with no differences between groups . Both exercise sequences in water-based concurrent training presented relevant improvements to promote health and physical fitness in postmenopausal women . However , the exercise sequence resistance – aerobic optimizes the strength gains in lower limbs Abstract Tan , JG , Coburn , JW , Brown , LE , and Judelson , DA . Effects of a single bout of lower-body aerobic exercise on muscle activation and performance during subsequent lower- and upper-body resistance exercise workouts . J Strength Cond Res 28(5 ) : 1235–1240 , 2014—A single bout of lower-body aerobic exercise may negatively affect a subsequent lower-body resistance exercise workout . However , less is known regarding the effects of a lower-body aerobic workout on muscle activation and performance during a subsequent upper-body resistance exercise workout . Therefore , the purpose of this study was to compare muscle activation and performance during lower- and upper-body resistance exercise workouts after a single bout of lower-body aerobic exercise on an elliptical machine . Fourteen men ( mean age = 24.1 ± 2.3 years , height = 180.8 ± 6.9 cm , body mass = 91.9 ± 16.4 kg ) completed 4 trials in r and om order . Two trials consisted of 30 minutes on the elliptical machine , using the lower body only , at 70 % of age-predicted maximum heart rate before either a back squat or bench press workout , consisting of 3 sets to failure performed at 75 % 1 repetition maximum . The other 2 trials consisted of only the back squat or bench press resistance workouts . To quantify muscle activation , bipolar surface electromyography electrodes were placed on the rectus femoris and vastus lateralis or pectoralis major . Acute lower-body aerobic exercise on an elliptical machine significantly reduced the number of repetitions completed for the back squat but not the bench press exercise . There was no significant difference in muscle activation between the elliptical and no elliptical conditions . However , for both exercises and conditions , muscle activation increased significantly between the first and final repetitions for the first 2 sets but not for the third set . These results suggest that to optimize the quality of a lower-body resistance-training workout , the workout should not be preceded by lower-body aerobic exercise The purpose of this study was to determine the physiological effects of a programmed accommodating circuit exercise ( PACE ) program consisting of aerobic exercise and hydraulic-resistance exercise ( HRE ) on fitness in older adults . Thirty-five volunteers were r and omly divided into two groups [ PACE group ( PG ) 8 men and 10 women , 68.3 ( 4.9 ) years , and non-exercise control group ( CG ) 7 men and 10 women , 68.0 ( 3.4 ) years ) . The PG participated in a 12-week , 3 days per week supervised program consisting of 10 min warm-up and 30 min of PACE ( moderate intensity HRE and aerobic movements at 70 % of peak heart rate ) followed by 10 min cool-down exercise . PACE increased ( P<0.05 ) oxygen uptake ( V̇O2 ) at lactate threshold [ PG , pre 0.79 ( 0.20 ) l min−1 , post 1.02 ( 0.22 ) l min−1 , 29 % ; CG , pre 0.87 ( 0.14 ) l min−1 , post 0.85 ( 0.15 ) l min−1 , −2 % ] and at peak V̇O2 [ PG , pre 1.36 ( 0.24 ) l min−1 , post 1.56 ( 0.28 ) l min−1 , 15 % ; CG , pre 1.32 ( 0.29 ) l min−1 , post 1.37 ( 0.37 ) l min−1 , 4 % ] in PG measured using an incremental cycle ergometer . Muscular strength evaluated by a HRE machine increased at low to high resistance dial setting s for knee extension ( 9–52 % ) , knee flexion ( 14–76 % ) , back extension ( 18–92 % ) and flexion ( 50–70 % ) , chest pull ( 6–28 % ) and press ( 3–17 % ) , shoulder press ( 18–31 % ) and pull ( 26–85 % ) , and leg press ( 21 % ) . Body fat ( sum of three skinfolds ) decreased ( 16 % ) , and high-density lipoprotein cholesterol ( HDLC ) increased ( 10.9 mg dl−1 ) for PG . There were no changes in any variables for CG . These results indicate that PACE training incorporating aerobic exercise and HRE elicits significant improvements in cardiorespiratory fitness , muscular strength , body composition , and HDLC for older adults . Therefore , PACE training is an effective well-rounded exercise program that can be utilized as a means to improve health-related components of fitness in older adults Concurrent training is an effective method for increasing skeletal muscle performance in aging individuals , but controversy exists as to whether chronic neuromuscular and functional adaptations are affected by the intra-session exercise sequence . Therefore the aim of this study was to evaluate the effect of concurrent endurance and power-like strength training exercise sequence on muscular and functional adaptations of older participants . Thirty-six healthy older men not engaged in systematic exercise training programs for at least 6 months were divided into a control group ( CON ; 65.8±5.3 years ) , or in the training groups : endurance-strength ( ES ; 63.2±3.3 years ) , or strength-endurance ( SE ; 67.1±6.1 years ) . Training groups underwent 12 weeks of concurrent endurance and power-like strength training , starting every exercise session with either endurance ( in ES ) or strength ( in SE ) exercises . Measurements included knee extension one repetition maximum ( 1RM ) , knee extension power , 30 second sit-to-st and test ( 30SS ) , maximum vastus lateralis surface electromyographic activity , and rectus femoris echo intensity ( RFEI ) . Significant increases in maximal strength ( ES + 18±11.3 % ; SE + 14.2±6.0 % ; p≤0.05 ) , peak power ( ES + 22.2±19.4 % ; SE + 26.3±31.3 % ; p≤0.05 ) , and 30SS performance ( ES + 15.2±7.2 % ; SE + 13.2±11.8 % ; p≤0.05 ) were observed only in the training groups , with no differences between ES and SE . Maximum \n Output:\n " }, { "from": "agent", "value": "Sequencing strength training prior to endurance in concurrent training appears to be beneficial for lower body strength adaptations , while the improvement of aerobic capacity is not affected by training order" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To examine the prospect i ve relation between total homocysteine and major coronary heart disease events . DESIGN A nested case – control study carried out within the British regional heart study , a prospect i ve investigation of cardiovascular disease in men aged 40–59 years at entry . Serum total homocysteine concentrations were analysed retrospectively and blindly in baseline sample s from 386 cases who had a myocardial infa rct during 12.8 years of follow up and from 454 controls , frequency matched by age and town . RESULTS Geometric mean serum total homocysteine was slightly higher in cases ( 14.2 μmol/l ) than in controls ( 13.5 μmol/l ) , a proportional difference of 5.5 % ( 95 % confidence interval ( CI ) −0.02 % to 10.8 % , p = 0.06 ) . Age adjusted risk of myocardial infa rct ion increased weakly with log total homocysteine concentration ; a 1 SD increase in log total homocysteine ( equivalent to a 47 % increase in total homo cysteine ) was associated with an increase in odds of myocardial infa rct ion of 1.15 ( 95 % CI 1.00 to 1.32 ; p = 0.05 ) . The relation was particularly marked in the top fifth of the total homocysteine distribution ( values > 16.5 μmol/l ) , which had an odds ratio of 1.77 ( 95 % CI 1.28 to 2.42 ) compared with lower levels . Adjustment for other risk factors had little effect on these findings . Total homocysteine concentrations more than 16.5 μmol/l accounted for 13 % of the attributable risk of myocardial infa rct ion in this study population . Serum total homocysteine among control subjects varied between towns and was correlated with town st and ardised mortality ratios for coronary heart disease ( r = 0.43 , p = 0.08 ) . CONCLUSIONS Serum total homocysteine is prospect ively related to increased coronary risk and may also be related to geographical variation in coronary risk within Britain . These results strengthen the case for trials of total homocysteine reduction with folate BACKGROUND A high serum total homocysteine ( tHcy ) concentration is a risk factor for death , but the strength of the relation in patients with type 2 ( non-insulin-dependent ) diabetes mellitus compared with nondiabetic subjects is not known . A cross-sectional study suggested that the association between tHcy and cardiovascular disease is stronger in diabetic than in nondiabetic subjects . We therefore prospect ively investigated the combined effect of hyperhomocysteinemia and type 2 diabetes on mortality . METHODS AND RESULTS Between October 1 , 1989 , and December 31 , 1991 , serum was saved from 2484 men and women , 50 to 75 years of age , who were r and omly selected from the town of Hoorn , The Netherl and s. Fasting serum tHcy concentration was measured in 171 subjects who died ( cases ; 76 of cardiovascular disease ) and in a stratified r and om sample of 640 survivors ( control subjects ) . Mortality risks were calculated over 5 years of follow-up by means of logistic regression . The prevalence of hyperhomocysteinemia ( tHcy > 14 micromol/L ) was 25 . 8 % . After adjustment for major cardiovascular risk factors , serum albumin , and HbA(1c ) , the odds ratio ( 95 % CI ) for 5-year mortality was 1.56 ( 1.07 to 2.30 ) for hyperhomocysteinemia and 1.26 ( 1.02 to 1 . 55 ) per 5-micromol/L increment of tHcy . The odds ratio for 5-year mortality for hyperhomocysteinemia was 1.34 ( 0.87 to 2.06 ) in nondiabetic subjects and 2.51 ( 1.07 to 5.91 ) in diabetic subjects ( P=0.08 for interaction ) . CONCLUSIONS Hyperhomocysteinemia is related to 5-year mortality independent of other major risk factors and appears to be a stronger ( 1.9-fold ) risk factor for mortality in type 2 diabetic patients than in nondiabetic subjects The relation of serum total homocysteine and lipoprotein(a ) ( Lp(a ) ) with the incidence of atherosclerotic disease was investigated among 7424 men and women aged 40 - 64 years free of atherosclerotic disease at baseline in 1977 . During the 9-year follow-up , 134 male and 131 female cases with either myocardial infa rct ion or stroke were identified . For each case a control subject was selected belonging to the same sex and 5-year age group . Serum sample s collected in 1977 were stored at -20 degrees C and analyzed in 1991 . The mean serum homocysteine concentration of male cases and controls was 9.99 mumol/l and 9.82 mumol/l at baseline and that of female cases and controls 9.58 mumol/l and 9.24 mumol/l , respectively . The median serum Lp(a ) concentration of male cases and controls was 73 mg/l and 108 mg/l and that of female cases and controls 113 mg/l and 91 mg/l , respectively . The differences between cases and controls were not statistically significant . There was also no significant association between either homocysteine or Lp(a ) and atherosclerotic disease , myocardial infa rct ion or stroke in logistic regression analyses . The odds ratios varied from 1.00 to 1.26 for homocysteine and from 0.81 to 1.06 for Lp(a ) . The results of this prospect i ve population -based study do not support the hypotheses that serum homocysteine or Lp(a ) are risk factors for atherosclerotic disease . The lack of association between serum homocysteine and atherosclerotic disease may be due to the exceptionally low gene frequency predisposing to homocysteinemia in Finl and Background —Sudden cardiac death ( SCD ) is an important cause of mortality even among apparently healthy population s. However , our ability to identify those at risk for SCD in the general population is poor , and more specific markers are needed . Methods and Results —To compare and contrast the relative importance of C-reactive protein ( CRP ) , homocysteine , and lipids as long-term predictors of SCD , we performed a prospect i ve , nested , case-control analysis involving 97 cases of SCD among apparently healthy men enrolled in the Physician ’s Health Study . Of these plasma markers measured , only baseline CRP levels were significantly associated with the risk of SCD over the ensuing 17 years of follow-up ( P for trend=0.001 ) . The increase in risk associated with CRP levels was primarily seen among men in the highest quartile , who were at a 2.78-fold increased risk of SCD ( 95 % CI 1.35 to 5.72 ) compared with men in the lowest quartile . These results were not significantly altered in analyses that ( in addition to the matching variables of age and smoking status ) controlled for lipid parameters , homocysteine , and multiple cardiac risk factors ( relative risk for highest versus lowest quartile 2.65 , 95 % CI 0.79 to 8.83;P for trend=0.03 ) . In contrast to the positive relationship observed for CRP , neither homocysteine nor lipid levels were significantly associated with risk of SCD . Conclusions —These prospect i ve data suggest that CRP levels may be useful in identifying apparently healthy men who are at an increased long-term risk of SCD BACKGROUND Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P<0.001 ) . The levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events CONTEXT Individuals with elevated levels of homocysteine tend to have higher prevalence of cardiovascular disease . However , prospect i ve studies of homocysteine are inconsistent and data among women are limited . OBJECTIVE To determine whether elevated homocysteine levels in healthy postmenopausal women predict risk of developing cardiovascular disease . DESIGN Prospect i ve , nested case-control study with a mean 3-year follow-up . SETTING The Women 's Health Study , an ongoing US primary prevention trial initiated in 1993 . PARTICIPANTS From a total cohort of 28,263 postmenopausal women with no history of cardiovascular disease or cancer at baseline , 122 women who subsequently experienced cardiovascular events were defined as cases , and 244 age- and smoking status-matched women who remained free of disease during follow-up were defined as controls . MAIN OUTCOME MEASURES Incidence of death due to cardiovascular disease , nonfatal myocardial infa rct ion ( MI ) , stroke , percutaneous transluminal coronary angioplasty , or coronary artery bypass graft by baseline homocysteine level . RESULTS Of the 122 cases , there were 85 events of MI or stroke and 37 coronary revascularizations . Case subjects had significantly higher baseline homocysteine levels than controls ( 14.1 vs 12.4 micromol/L ; P = .02 ) . Subjects with homocysteine levels in the highest quartile had a 2-fold increase in risk of any cardiovascular event ( relative risk [ RR ] , 2.0 ; 95 % confidence interval [ CI ] , 1.1 - 3.8 ) . This effect was largely due to an excess of cases with high levels of homocysteine ; the RR for those with homocysteine levels at or higher than the 95th percentile ( 20.7 micromol/L ) was 2.6 ( 95 % CI , 1.1 - 5.7 ) . Risk estimates were independent of traditional risk factors and were greatest for the end points of MI and stroke ( RR for those with baseline homocysteine levels in the top quartile , 2.2 ; 95 % CI , 1.1 - 4.6 ) . Self-reported multivitamin supplement use at study entry was associated with significantly reduced levels of homocysteine ( P<.001 ) . However , the association between increasing quartile of homocysteine level and risk of MI or stroke remained significant in analyses controlling for baseline multivitamin supplement use ( P = .003 for trend ) , and subgroup analyses limited to women who were ( P = .02 for trend ) or were not ( P = .04 for trend ) taking multivitamin supplements . CONCLUSIONS Among healthy postmenopausal US women , \n Output:\n " }, { "from": "agent", "value": "Each increase of 5 micromol/L in homocysteine level increases the risk of CHD events by approximately 20 % , independently of traditional CHD risk factors" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Forty eight elderly Thai patients , 12 demented , 36 non-demented who consecutively attended a geriatric clinic , at Chulalongkorn University Hospital , with a memory problem were recruited in the study which aim ed to determine the validity of the clock-drawing test ( CDT ) and Chula mental test ( CMT ) . Subjects took the Chula Mental Test ( CMT ) and were asked to draw a clock on a preprinted 12 centimeters circle showing the time of 11:10 . Clocks were scored using the Chula Clock-drawing Scoring System ( CCSS ) . Ten subjects voluntarily participated and completed the WAIS test . The best cutoff score of the CMT and the CDT using diagnosis of dementia as a gold st and ard were 15 and 7 respectively . Sensitivity and specificity for detecting dementia by the CDT were 100 per cent and 94.1 per cent respectively . Sensitivity and specificity for detecting dementia by the CMT were 83.3 per cent 91.7 per cent . The likelihood ratio ( 95 % confidence interval ) of the CMT and the CDT were 10 ( 3.3 - 30.4 ) and 17 ( 4.4 - 65.2 ) respectively . There was a good correlation of the CDT score and the CMT score with the WAIS score . Although the CDT was better than the CMT in literate patients , the CDT had limitation of use among illiterate patients but not the CMT . The benefits of simultaneously application on dementia screening was shown . This study showed that the CDT was a valuable , brief method of dementia screening in elderly Thai patients with memory problems BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions OBJECTIVES To assess the usefulness , relative ease of administration , and patient acceptance of the clock drawing test as well as the time and change test for detecting dementia in Chinese elderly adults . DESIGN Prospect i ve case-controlled study . SETTING Memory clinic and geriatric clinic of a district hospital , Hong Kong . PARTICIPANTS A convenient sample of 85 subjects aged 65 years or older attending the two clinics during the period from September 2002 to June 2003 . MAIN OUTCOME MEASURES The clock drawing test scored according to Lam 's method ; the time and change test with modification to the making change task ; and the Chinese version of the Mini-Mental State Examination . RESULTS Demented subjects were matched with non-demented ones with respect to age , sex , educational level , and co-morbidity status . The clock drawing test had a comparable sensitivity ( 89.4 % ) but a lower specificity ( 47.1 % ) when compared with that of the Chinese version of the Mini-Mental State Examination ( 96.0 and 76.5 % , respectively ) . In contrast , the time and change test had a lower sensitivity ( 62.7 % ) but higher specificity ( 94.1 % ) . Both tests took significantly less time to complete than the Chinese version of the Mini-Mental State Examination . All except four subjects completed the clock drawing test while all subjects accepted the time and change test well . CONCLUSIONS The Chinese version of the Mini-Mental State Examination is still the best among the three tests despite the longer time to completion . The clock drawing test may be a good alternative to the Mini-Mental State Examination as an effective screening test for dementia when time does not permit . The time and change test , although time-saving , is not suitable to be used alone because of its low sensitivity BACKGROUND As elderly population s grow , dementia detection in the community is increasingly needed . Existing screens are largely unused because of time and training requirements . We developed the Mini-Cog , a brief dementia screen with high sensitivity , specificity , and acceptability . Here we describe the development of its scoring algorithm , its receiver operating characteristics ( ROC ) , and the generalizability of its clock drawing scoring system . SAMPLE AND METHODS A total of 249 multi-lingual older adults were examined . Scores on the three-item recall task and the clock drawing task ( CDT-CERAD version ) were combined to create an optimal algorithm . Receiver operating characteristics for seven alternatives were compared with those of the MMSE and the CASI using expert raters . To assess the CDT scoring generalizability , 20 naïve raters , without explicit instructions or prior CDT exposure , scored 80 r and omly selected clocks as \" normal \" or \" abnormal \" ( 20 from each of four CERAD categories ) . RESULTS An algorithm maximizing sensitivity and correct diagnosis was defined . Its ROC compared favorably with those of the MMSE and CASI . CDT concordance between naïve and trained raters was > 98 % for normal , moderately and severely impaired clocks , but lower ( 60 % ) for mildly impaired clocks . Recalculation of the Mini-Cog 's performance , assuming that naïve raters would score all mildly impaired CDTs in the full sample as normal , retained high sensitivity ( 97 % ) and specificity ( 95 % ) . CONCLUSION The Mini-Cog algorithm performs well with simple clock scoring techniques . The results suggest that the Mini-Cog may be used successfully by relatively untrained raters as a first-stage dementia screen . Further research is needed to characterize the Mini-Cog 's utility when population dementia prevalences are low The ten‐point clock test is administered by tracing an 11·4 cm ( 4 1/2 inch ) diameter circle on a piece of paper and asking the patient to ‘ Write the numbers in the face of a clock ’ . The patient is then asked to ‘ Make the clock say 10 minutes after 11 ’ . The spacing of the numbers and the positions of the h and s are used to score the test . A score of less than eight points identified 71 % of patients with Alzheimer 's disease who had a Mini‐Mental State Examination score of greater than 23 . The specificity measured in elderly controls was 82 % . The test may prove useful in screening for early stage Alzheimer 's disease . Copyright © 1999 John Wiley & Sons , OBJECTIVE To assess the accuracy of clock drawing for detecting dementia in a multicultural , non-English-speaking- background population . DESIGN A prospect i ve cohort study . SETTING A general geriatric medical outpatient clinic in southwest Sydney , Australia . PARTICIPANTS Ninety-three consecutive new patients to the clinic who had a non-English-speaking- background country of birth ( mean age 78.0 years ) . MEASUREMENTS The clock drawing test was conducted at the beginning of each clinic visit by a blinded investigator . Each patient was then assessed by a geriatrician who collected demographic data , administered the Modified Barthel Index , the Geriatric Depression Scale , and the Folstein Mini-Mental State Examination , and categorized each patient as normal or demented , according to DSM-IV criteria . Interpreters were used for participants who spoke a language other than English or who requested them . Each clock drawing was scored according to the 4-point CERAD scale and the previously published methods of Mendez , Shulman , Sunderl and , Watson , and Wolf-Klein . Scoring was evaluated for reliability and predictive accuracy , using receiver operating characteristic ( ROC ) curve analysis . Logistic regression analysis was used to assess the potential interaction between level of education and each of the clock scoring methods . RESULTS Using ROC curve analysis , there was no significant difference between the clock scoring methods ( area under the curve varied from 0.60 to 0.72 ) . The most sensitive was the Mendez scoring method ( 98 % ) , with a specificity of 16 % . Specificity above 50 % was found only for the Wolf-Klein method , with an intermediate sensitivity of 78 % . CONCLUSIONS There were no significant differences in the clock scoring methods used to detect dementia . Performance of the clock drawing test was modest at best with low levels of specificity across all methods . Scored according to these methods , clock drawing was not a useful predictor of dementia in our multicultural population INTRODUCTION The Clock Drawing Test ( CDT ) has been used in recent years as a simple neuropsychological instrument to assess cognitive deterioration associated with dementia , even though uniform operative criteria with respect to its application and scoring have not been established . OBJECTIVE To present application normatives and establish the most relevant psychometric criteria of the CDT in a sample of healthy subjects ( HS ) and patients with Alzheimer 's disease ( AD ) . PATIENTS AND METHODS 56 patients were selected of which 35 were female and 21 were male . The patients ' mean age was 72.7 with a st and ard deviation of 7.64 . All of whom where probable AD patients according to the NINCDS-ADRDA criteria at stage 1 CDR . The group of HS was made up of 56 control subjects ( 34 female , 22 male ) with a mean age of 72.14 and a st and ard deviation of 7.2 . The CDT was applied in both its comm and ( COM ) and copy ( COP ) experimental conditions . RESULTS The main psychometric parameters analysed in the studied series showed the following values : internal consistency ( Cronbach 's alpha coefficient 0.9029 ) ; cut off point CT COM 6 with 92.80 , sensitivity ; false negatives ( FN ) 7.2 with a specificity rating 93.48 ; false positive ( FP ) 6.52 with 93.16 efficacy ; cut off point CT COP 8 with 73.11 sensitivity ; FN 26.89 with 90.58 specificity ; FP 9.42 with 82.49 efficacy . CONCLUSION The CDT can be used to discriminate between HS and those in the initial stages of AD in the given sample using the established application and scoring criteria OBJECTIVE To develop a simple , readily administered and scored screening test for dementia utilizing the clock-drawing task . DESIGN Retrospective analysis of clock-drawing errors and prospect i ve validations . SETTING Hospital-based outpatient geriatric assessment clinic , rehabilitation service , apartment building for older adults , and long-term care facility . PARTICIPANTS Convenience sample of patients attending the geriatric assessment clinic , patients on the rehabilitation service , or residents of the above sites . MEASUREMENTS Sensitivity and specificity of a clock-scoring system in identifying patients with dementia and the comparison of this system with the Short Blessed Test ( SBT ) in the diagnosis of dementia and in the prospect i ve validation of the test . RESULTS Of the 10 clock-drawing errors evaluated , placement of digits in a pre-drawn circle had the greatest sensitivity and specificity in distinguishing patients with irreversible dementia from patients with other disorders who did not meet NINCDS-ADRDA criteria for probable dementia . The derived scoring system had a sensitivity of 87 % and a specificity of 82 % , compared with a sensitivity of 82 % and a specificity of 88 % for the SBT in identifying dementia . Test-retest reliability for the distinction between demented and non-demented was 82 % , with a Kappa of 0.63 for the clock completion , and 82 % , with a Kappa of 0.62 for the SBT . Inter-rater reliability for clock completion was 0.90 to 0.93 . CONCLUSION A simple , completely objective scoring system for a clock completion test has been developed which involves only the number of digits placed in the fourth quadrant of a pre-drawn circle . This readily administered test is as effective in screening for dementia as the longer six-item SBT Causes of cognitive impairment in the elderly include dementia , delirium , toxic effects of medications , trauma , and psychiatric illness . Dementia is the most common cause , and it implies a decline in cognitive function severe enough to interfere with social functioning . The estimated prevalence of dementia is \n Output:\n " }, { "from": "agent", "value": "The correlation with other st and ard screening tests was statistically significant in most studies , but the results were influenced by age , education and language .\nIn studies that included patients with mild or question able dementia , the CDT had a low sensitivity and variable specificity .\nConclusion : The CDT has the characteristics of a good screening method for moderate and severe dementia ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To compare two surgical techniques ( denervation levels ) for sympathectomy using video-assisted thoracoscopy to treat palmar hyperhidrosis in the long-term . METHODS From May 2003 to June 2006 , 60 patients with palmar hyperhidrosis were prospect ively r and omized for video-assisted thoracoscopic sympathectomy at the T2 or T3 ganglion level . They were followed for a mean of 20 months and were evaluated regarding their degree of improvement of palmar hyperhidrosis , incidence and severity of compensatory hyperhidrosis and its evolution over time , and quality of life . RESULTS Fifty-nine cases presented resolution of the palmar hyperhidrosis . One case of therapeutic failure occurred in the T3 group . Most of the patients presented an improvement in palmar hyperhidrosis , without any difference between the groups . Twenty months later , all patients in both groups presented some degree of compensatory hyperhidrosis but with less severity in the T3 group ( p = 0.007 ) . Compensatory hyperhidrosis developed in most patients during the first month after the operation , with incidence and severity that remained stable over time . An improvement in quality of life was seen starting from the first postoperative evaluation but without any difference between the groups . This improvement was maintained until the end of the follow-up . CONCLUSION Both techniques were effective for treating palmar hyperhidrosis . The most frequent complication was compensatory hyperhidrosis , which presented stable incidence and severity over the study period . Sympathectomy at the T3 level presented compensatory hyperhidrosis with less severity . Nevertheless , the improvement in quality of life was similar between the groups BACKGROUND Compensatory sweating ( CS ) is one of the most common postoperative complications after thoracic sympathectomy , sympathicotomy or endoscopic sympathetic block ( ESB ) for palmar hyperhidrosis . This study was conducted to examine the relevance between CS and the sympathetic segment being transected in the surgical treatment of palmar hyperhidrosis , and thus to detect the potential mechanism of the occurrence of CS . METHODS Between October 2004 and June 2006 , 163 patients with primary hyperhidrosis were r and omly divided into two groups , T(3 ) sympathicotomy ( 78 patients ) and T(4 ) sympathicotomy ( 85 ) , who were operated upon under general anesthesia via single lumen intubation and intercostal video-mediastinoscopy ( VM ) . RESULTS No morbidity or mortality occurred . Palmar hyperhidrosis was cured in all patients . Follow-up ( mean ( 13.8 + /- 6.2 ) months ) showed no recurrence of palmar hyperhidrosis . The difference of rates of mild CS in groups T(3 ) and T(4 ) was of no statistical significance . The rate of moderate CS was significantly lower in group T(4 ) than in group T(3 ) . No severe CS occurred . CONCLUSION The rates of occurrence and severity of CS are lowered with the lower sympathetic chain being transected BACKGROUND Compensatory sweating is a major and troublesome complication noted frequently after sympathectomy in patients with primary palmar hyperhidrosis . This r and omized clinical trial was projected to measure the impact of limited denervation on compensatory sweating while performing endoscopic thoracic sympthectomy . METHODS Two hundred thirty-two patients with primary palmar hyperhidrosis were r and omly allocated to either a T3 sympathectomy treatment , called group T3 , or a T2 - 4 sympathetic treatment , called group T2 - 4 . The patients underwent bilateral sympathetic ablation at corresponding levels . All patients were followed up and evaluated for comparison of symptom resolution , postoperative complication , levels of satisfaction , and severity of compensatory sweating between the two groups . RESULTS Sex , age , family history , and distribution of sweating were similar in both groups . The postoperative complications were minor , and Horner 's syndrome was not detected in either group . The frequency of mild and moderate compensatory sweating was not significantly different between the two groups , but the incidence of severe compensatory sweating was significantly lower after T3 sympathectomy ( 3 % versus 10 % ) . As for satisfaction rate , group T3 was superior to group T2 - 4 ( 96.6 % versus 89.6 % ) . The rate of symptom resolution was 100 % , and no recurrence was found in either group . CONCLUSIONS The single-level sympathetic denervation under thoracoscopy is a safe and effective procedure to treat primary palmar hyperhidrosis . This method reduces the incidence of severe compensatory sweating postoperatively without compromising the patient 's satisfaction Background In this study , patients treated by thoracoscopic sympathicolysis for palmar hyperhidrosis were evaluated to determine the number and response of sweat gl and s to intradermal acetylcholine stimulus . Methods A total of 30 patients were included in the study . Group A consisted of 10 patients with palmar hyperhidrosis who underwent thoracoscopic sympathicolysis in October 2005 , and group B consisted of 20 patients who underwent surgery during the years 1999 , 2000 , and 2001 . The study procedure involved applying iodine alcohol to the palm and then intradermally injecting 0.1 ml 1 % acetylcholine . This activated the sweat gl and s , which were then photographed and counted . The study procedure was performed prospect ively over different periods in group A and retrospectively in group B. Results In group A , the mean number of gl and s activated 1 , 3 , 6 , and 12 months after surgery were 41 , 174.20 , 522.8 , and 747.2 , respectively ; this gradual increase was statistically significant over the first 6 months ( p = 0.004 ) but not between months 6 and 12 ( p = 0.255 ) . The trend towards an increasing number of active gl and s occurred in both groups , with a mean of 1369.8 active gl and s in group B compared to 747.2 ( p = 0.095 ) in group A after 12 months . Conclusion It is well-known that Cannon ’s law of denervation ( 1939 ) is not applicable to the sweat gl and s , that is , there is no hyperactivation following intradermal acetylcholine stimulation . However , some response , which increased over the first 6 months following surgery , was observed in our study . Nevertheless , this activation is subsequently self-limiting , result ing in no gl and atrophy , and reinnervation occurs without patient awareness This study compares the results obtained of video-assisted sympathectomy performed on two distinct ganglion levels ( third vs. fourth thoracic ganglion ) in the treatment of palmar hyperhidrosis ( PH ) , through a blind r and omized clinical trial . All participants were r and omized into two groups of 20 patients ( G3 and G4 ) and underwent the operation , and were followed for 12 months . We used an objective method for measuring sweat , checking the transepidermal water loss ( TEWL ) , and evaluated the quality -of-life ( QoL ) before and after the operation . All patients ( n=40 ) ceased suffering from PH after surgery , with statistical difference when we compared the values of TEWL palmar preoperatively with their respective values at one week , one month , six months and 12 months . The main side effect observed was compensatory hyperhidrosis ( CH ) , which was most frequent in G3 after 12 months of follow-up . There was an improvement in QoL since the first evaluation of the postoperative period with no difference between groups . Both techniques were effective in the treatment of PH , generating objective reduction of TEWL regardless of the ganglion operated . Sympathectomy G3 had a higher incidence of CH , yet the improvement in QoL was similar in both groups BACKGROUND Thoracoscopic sympathicotomy is highly effective in treating disabling palmar hyperhidrosis . The ideal level to maximize efficacy and minimize the side effect of compensatory hyperhidrosis ( CH ) is controversial . This study compared sympathicotomy over the second ( R2 ) vs third ( R3 ) costal head relative to these variables in patients with massive palmar hyperhidrosis . METHODS This prospect i ve , r and omized study enrolled 121 patients with disabling palmoplantar hyperhidrosis assigned to bilateral sympathicotomy ( sympathetic transection ) , which was done over R2 in 61 ( n = 122 extremities ) or R3 in 60 ( n = 120 extremities ) . Patients were question ed at 6 months and at 1 year or more to assess efficacy , side effects , and satisfaction with the procedure . RESULTS Sympathicotomy at R2 failed to cure palmar hyperhidrosis in 5 of 122 ( 4.1 % ) extremities , but only 2 ( 1.6 % ) were to a truly profound dripping level of recurrence . Sympathicotomy at R3 failed to cure palmar hyperhidrosis in 5 of 120 extremities ( 4.2 % ) , and all were dramatic failures with dripping recurrent sweating . The patients whose palmar hyperhidrosis was not completely cured were aged 19.7 ± 2.5 vs 26.4 ± 8.0 years ( p = 0.04 ) . Two R3 patients with failure underwent three redo R2 sympathicotomies , with curative results . R2 patients showed a trend toward a higher level of CH vs R3 patients at 6 months and after 1 year . The CH severity scale was 4.7 ± 2.7 ( n = 38 ) for R2 vs 3.8 ± 2.8 ( n = 36 ) for R3 ( p = NS ) at 6 months and 4.7 ± 2.5 ( n = 43 ) for R2 vs 3.7 ± 2.8 ( n = 37 ) for R3 ( p = NS ) after 1 year . Younger age , male sex , and higher levels of preoperative and postoperative plantar sweating were predictors of failed sympathicotomy . Increased age was associated with increased CH . CONCLUSIONS R2 and R3 sympathicotomy for massive palmoplantar hyperhidrosis are highly effective , with low recurrence and incidences of severe CH . R2 tends to have a higher level of CH vs R3 , and a higher incidence of dramatic failures is suggested in R3 patients , for which reoperation at the R2 level will likely be curative OBJECTIVE Endoscopic thoracic sympathetic surgery was effective for palmar hyperhidrosis ( PH ) , but side effects such as compensatory sweating and over dry h and s were common . A multiple centers prospect i ve r and omized study was design ed to compare the efficiency and side effects of T3 and T4 sympathicotomy in the treatment of PH . METHODS From September 2004 to February 2006 , 141 consecutive patients with PH were r and omized into two therapeutic groups : group T3 underwent T3 sympathicotomy ( n=68 ) and group T4 underwent T4 sympathicotomy ( n=73 ) . Improvement of h and sweating , side effects like compensatory sweating or over dry h and s , and satisfactory rate of the patients were recorded . RESULTS There were 78 males and 63 females . The median age was 26.9 years . The two groups were comparable in gender , age , severity of sweating and average period of follow-up . All operations were successful with no severe complications or perioperative mortality . A 17.8+/-7.9 month follow-up showed that palmar sweating improved in all patients and the effective rate was 100 % . Mild moist h and s occurred more frequent in group T4 than in group T3 ( 59.4 % vs 25.8 % , p<0.0001 ) . Most involved patients were ' very satisfied ' with this result except for four patients ( 5.8 % ) in group T4 ; incidences of compensatory sweating and over dry h and s were both lower in group T4 than in group T3 ( 56.5 % vs 77.4 % , p=0.011 and 1.4 % vs 12.9 % , p=0.013 , respectively ) . Moderate compensatory sweating ( CS ) occurred in 14.5 % in group T3 and 2.9 % in group T4 ( p=0.017 ) . ' Very satisfied ' rate was higher in group T4 than in group T3 ( p<0.0001 ) while ' partially satisfied ' rate was comparable between the two groups . CONCLUSION T3 and T4 sympathicotomies are both effective for the treatment of PH . T4 sympathicotomy , decreases the side effects but do not compromise the therapeutic effects , and should be the method of choice \n Output:\n " }, { "from": "agent", "value": "No significant differences were found in symptom resolution and recurrence .\nT4 TS appears to be more useful than T3 or T2 TS for PH" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective . To assess a text messaging intervention to promote tuberculosis ( TB ) treatment adherence . Methods . A mixed- methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina . Patients newly diagnosed with TB who were 18 or older , and had mobile phone access were recruited and r and omized to usual care plus either medication calendar ( n = 19 ) or text messaging intervention ( n = 18 ) for the first two months of treatment . Primary outcomes were feasibility and acceptability ; secondary outcomes explored initial efficacy . Results . Feasibility was evidence d by high access to mobile phones , familiarity with texting , most phones limited to basic features , a low rate of participant refusal , and many describing suboptimal TB underst and ing . Acceptability was evidence d by participants indicating feeling cared for , supported , responsible for their treatment , and many self-reporting adherence without a reminder . Participants in the texting group self-reported adherence on average 77 % of the days whereas only 53 % in calendar group returned diaries . Exploring initial efficacy , microscopy testing was low and treatment outcomes were similar in both groups . Conclusion . The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary . Further evaluation of the texting intervention is warranted BACKGROUND AND METHODS The frequency of infection with multidrug-resistant Mycobacterium tuberculosis is increasing . We review ed the clinical courses of 171 patients with pulmonary disease due to M. tuberculosis resistant to rifampin and isoniazid who were referred to our hospital between 1973 and 1983 . The patients ' records were analyzed retrospectively . Their regimens were selected individually and preferably included three medications that they had not been given previously and to which the strain was fully susceptible . RESULTS The 171 patients ( median age , 46 years ) had previously received a median of six drugs and shed bacilli that were resistant to a median of six drugs . Thus , their regimens were frequently not optimal . Of 134 patients with sufficient follow-up data , 87 ( 65 percent ) responded to chemotherapy ( as indicated by negative sputum cultures for at least three consecutive months ) ; 47 patients ( 35 percent ) had no response , as shown by continually positive cultures . The median stay in the hospital was more than seven months . In a multivariate analysis , an unfavorable response was significantly associated with a greater number of drugs received before the current course of therapy ( odds ratio , 4.0 ; 95 percent confidence interval , 1.6 to 9.9 ; P < 0.001 ) and with male sex ( odds ratio , 2.5 ; 95 percent confidence interval , 1.1 to 6.2 ; P < 0.03 ) . Twelve of the patients with responses subsequently had relapses . The overall response rate was 56 percent over a mean period of 51 months . Of the 171 patients , 63 ( 37 percent ) died , and 37 of these deaths were attributed to tuberculosis . CONCLUSIONS For patients with pulmonary tuberculosis that is resistant to rifampin and isoniazid , even the best available treatment is often unsuccessful . Only about half of such patients eventually have negative sputum cultures despite carefully selected regimens administered for extended periods . Failure to control this resistant infection is associated with high mortality and ominous implication s for the public health A r and omized controlled study was undertaken to compare 2 policies of default management in out- patients with smear-negative pulmonary tuberculosis attending a large chest clinic in Madras city . All the patients were due to collect monthly supplies of drugs for a year , for daily self-administration at home . In the routine ( R ) policy , if a patient failed to collect the drug supply on a due date , a reminder letter was posted on the fourth day and , if necessary , a health visitor visited the home a week later . In the intensive ( I ) policy , a health visitor visited the home on the 4th day and , if necessary , a week later and at 1 and at 2 months . The main analyses concern 150 patients ( 75 R , 75 I ) , of whom 16 R and 15 I patients had a positive culture . A total of 29 patients ( 11 R , 18 I ) did not default at any time . For the remaining 64 R and 57 I patients , the mean numbers of defaults were 3.0 and 2.3 , and the mean numbers of defaulter retrieval actions were 4.3 and 3.8 , respectively . The home visit as the first action ( I series ) was successful in retrieving defaulters on 65 % of 132 occasions , while the reminder letter ( R series ) was successful in 56 % of 193 occasions ( P = 0.1 ) . Following the second action , which was a home visit in both the series , these proportions became 80 % and 84 % , respectively . in the I series , 22 third and 18 fourth actions were taken , but the patient was retrieved in only 4 and 0 instances respectively . The mean number of drug collection s during the year was significantly higher in the I series ( 9.8 ) than in the R series ( 8.6 ) . Finally , the proportions of patients who made 12 collection s in a 15-month period , a satisfactory target under Indian Programme conditions , were 69 % and 52 % , respectively ( P = 0.07 ) Background Tuberculosis is a public health problem in Cameroon , just like in many other countries in the world . The National Tuberculosis Control Programme ( PNLT ) put in place by the state , aims to fight tuberculosis through the implementation of international directives ( Directly Observed Treatment Short , DOTS ) . Despite the deployment of this strategy across the world , its implementation is difficult in the context of low-re source countries . Some expected results are not achieved . In Cameroon , the cure rate for patients with sputum positive pulmonary tuberculosis ( TPM+ ) after 6 months is only about 65 % , 20 % below the target . This is mainly due to poor patient adherence to treatment . By relying on the potential of mobile Health , the objective of this study is to evaluate the effect of SMS reminders on the cure rate of TPM + patients , measured using 6-month bacilloscopy . Methods / design This is a blinded , r and omised controlled multicentre study carried out in Cameroon . The research hypothesis is that sending daily SMS messages to remind patients to take their prescribed tuberculosis medication , together with the st and ard DOTS strategy , will increase the cure rate from 65 % ( control group : DOTS , no SMS intervention ) to 85 % ( intervention group : DOTS , with SMS intervention ) in a group of new TPM + patients . In accordance with each treatment centre , the participants will be r and omly allocated into the two groups using a computer program : the intervention group and the control group . A member of the research team will send daily SMS messages . Study data will be collected by health professionals involved in the care of patients . Data analysis will be done by the intention-to-treat method . Discussion The achieving of expected outcomes by the PNLT through implementation of DOTS requires several challenges . Although it has been demonstrated that the DOTS strategy is effective in the fight against tuberculosis , its application remains difficult in developing countries . This study explores the potential of mHealth to support DOTS strategy . It will gather new evidence on the effectiveness of mHealth-based interventions and SMS reminders in the improvement of treatment adherence and the cure rate of tuberculosis patients , especially in a low-re source country such as Cameroon . Trial registration The trial is registered on the Pan-African Clinical Trials Registry ( http://www.pactr.org ) under unique identification number : PACTR201307000583416 INTRODUCTION This study assessed the impact of automated telephone reminders on tuberculin skin test returns . METHODS A total of 701 English-speaking and Spanish-speaking patients of a public health immunization program were r and omly assigned to an intervention or a control group . Those in the intervention group received an automated telephone reminder to return for the reading of their skin test . RESULTS Automated telephone reminders significantly reduced return failures 53 % ( from 14 % to 7 % ) when the scheduled interval between test administration and reading was three days , but had no impact for a two-day interval . Effectiveness of reminders did not differ significantly by patient age , gender , or language ( English versus Spanish ) . CONCLUSIONS Results suggest the value of automated reminder calls for intra-appointment intervals as short as three days OBJECTIVES We sought to determine the efficacy of coaching Latino adolescents with latent tuberculosis infection to adhere to isoniazid treatment . METHODS Participants ( n = 286 ) were r and omly assigned to adherence coaching , attention control , or usual care groups . Adherence was measured via interviews and vali date d with urine assays . RESULTS Coaching result ed in significant increases in adherence compared with attention and usual care groups . Bicultural adolescents were more likely to be adherent than those most or least acculturated . Age and risk behavior were negatively related to adherence . CONCLUSIONS Coaching can increase Latino adolescents ' adherence to treatment for latent tuberculosis infection and should contribute to tuberculosis control for adolescents at high risk of contracting the disease The design , logic , and results of a two-year health education study directed at i m proving rates of patient adherence to antituberculosis medical regimens are presented . An incentive scheme to reward positive health behaviors plus targeted educational coun seling sessions was implemented in a r and omized clinical controlled trial . The 205 subjects who participated in the study are categorized according to patients with active tuberculosis ( n = 88 ) or preventive patients with no evidence of active disease ( n = 117 ) . Patients in each of these groups were r and omly assigned to a special intervention ( SI ) group or a usual care ( UC ) control group and were followed monthly throughout their treatment program . While SI patients with active tuberculosis demonstrated higher levels of ap pointment-keeping behavior and mean percent of medication taken compared to UC patients , no statistically significant differences between the two groups were found . Pre ventive therapy patients assigned to the SI group , however , were significantly more likely than UC patients to remain in care during their 12-month regimen ( 64 % vs 47 % ; p = .003 ) . Furthermore , SI patients had significantly higher levels of adherence to their medical regimen compared to UC patients ( 68 % vs 38 % ; p < .001 ) . These results demonstrate the positive effects of a structured health education program on the i m provement of continuity of care and adherence behavior among patients with tuberculosis . This study was funded by the Centers for Disease Control through contract # 200 - 85 - 0835 . The assistance of the Project Clerk , Sook Hee Treadwell , the Project Health Educators , Magda Fischer , Jennifer Adams , Nancy Murray , Fred Dominguez , and the clinic staff and patients who participated in this project are gratefully acknowledged . 1 . US Department of Health and Human Services , Public Health Service : The 1990 Health Objectives for the Nation : A Midcourse Review . Office of Disease Prevention and Health Promotion , 1986 . 2 . Centers for Disease Control . Tuberculosis — Provisional data —United States , 1986 . MMWR 36 : 254 - 255 , 1987 . 3 . Centers for Disease Control . Tuberculosis . Final Data —United States , 1986 . MMWR 36 : 817 - 820 , 1988 . 4 . County of Los Angeles , Department of Health Services , Public Health Programs : Communicable Disease Morbidity Report , County of Los Angeles , 1986 . 5 . Kopanoff DE , Snider DE , Johnson M : Recurrent tuberculosis : Why do patients develop disease again ? A United States Public Health Service Cooperative Survey . Am J Public Health 78 : 30 - 33 , 1988 . 6 . American Thoracic Society : Treatment of tuberculosis and tuberculosis infection in adults and children . Am Rev Respir Dis 134 : 355 - 363 , 1986 . 7 . Haynes RB : Introduction , in RB Haynes , DW Taylor , DL Sackett . ( eds ) : Compliance in Health Care . Baltimore , Johns Hopkins University Press , 1979 , pp 1 - 7 . 8 . Sackett DL , Haynes RB , editor : Compliance with Therapeutic Regimens . Baltimore , Johns Hopkins University Press , 1976 . 9 . Haynes RB , Taylor DW , Sackett DL , ed : Compliance in Health Care . Baltimore , Johns Hopkins University Press , 1979 . 10 . Meichenbaum D , Turk DC : Facilitating Treatment Adherence : A Practitioner 's Guidebook . Plenum Press , New York , 1987 . 11 . Addington WW : Patient compliance : The most serious remaining problem in the control of tuberculosis in the United States . Chest 76 (supp):741 - 743 , 1979 . 12 . Report of the Committee : A Strategic Plan for the Elimination of Tuberculosis in the United States . US Department of Health and Human Services , Centers for Disease Control , May 1988 . 13 . Comstock GW : New data on preventive treatment with isoniazid . Annals of Internal Medicine 98:663 - 665 , 1983 . 14 . Cross FS , Long MW , Banner AS , Snider DE Jr : Rifampin-isoniazid therapy of alcoholics and nonalcoholic tuberculosis \n Output:\n " }, { "from": "agent", "value": "Authors ' conclusions Policies of sending reminders to people pre‐appointment , and contacting people who miss appointments , seem sensible additions to any TB programme , and the limited evidence available suggests they have small but potentially important benefits ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Several drugs which react with DNA decrease hepatitis B viral ( HBV ) DNA polymerase activity in vitro . Because such an alteration of viral replication , if produced in patients with hepatitis B surface antigen (HBsAg)-positive chronic hepatitis , may lead to elimination of viral infection , we conducted a controlled trial of the use of the intercalating agent , quinacrine hydrochloride , in treatment of HBsAg-positive chronic hepatitis . No patient converted from HBsAg positive to negative during the trial and no consistent effect on HBV DNA polymerase activity was noted . Following treatment , elevated transaminase values and alterations of HBV markers were observed in several patients . Fluctuations of transaminase values and HBV markers may reflect alterations in host immunity and viral replication . Quinacrine alone is ineffective in therapy of chronic HBV infection . Additional study with intercalating agents , perhaps in conjunction with other drugs , is suggested In a preliminary study , carriers of hepatitis B virus were treated with a preparation of the plant Phyllanthus amarus for 30 days . 22 of 37 ( 59 % ) treated patients had lost hepatitis B surface antigen when tested 15 - 20 days after the end of the treatment compared with only 1 of 23 ( 4 % ) placebo-treated controls . Some subjects have been followed for up to 9 months . In no case has the surface antigen returned . Clinical observation revealed few or no toxic effects . The encouraging results of this preliminary study recommend continued evaluation of this plant and the active principles isolated from it We studied the effect of Sho-saiko-to ( Xiao-Chai-Hu-Tang ) on HBeAg clearance rate ( SN rate ) in fourteen children with chronic hepatitis B virus ( HBV ) infection and with sustained liver disease . Seven of fourteen patients ( 50.0 % ) became HBeAg negative in the average observation period of 0.47 years(0.2 - 0.9 years ) . Four of those seven patients developed anti-HBe . The annual SN rate in the She-saiko-to treated group was apparently higher than the natural annual SN rate ( 22.7 % ) of 22 untreated patients retrospectively review ed from the onset of hepatitis . Sho-saiko-to seemed to promote clearance of HBeAg in children with chronic HBV infection and with sustained liver disease . Sho-saiko-to may be a useful drug for such patients OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries BACKGROUND In patients with chronic hepatitis B , treatment with interferon alfa and the consequent loss of hepatitis B e antigen ( HBeAg ) from the blood leads to a reduction in inflammatory activity , but the clinical benefits of this treatment have not been established . We evaluated whether HBeAg seroconversion induced by interferon alfa improves clinical outcome . METHODS We studied prospect ively a cohort of 103 patients treated with interferon alfa for chronic hepatitis B ; the mean ( + /- SD ) follow-up was 50.0 + /- 19.8 months . Fifty-three untreated patients served as controls . RESULTS After treatment with interferon alfa , 53 of 103 patients no longer had detectable HBeAg or hepatitis B virus DNA , although only 10 patients became seronegative for hepatitis B surface antigen ( HBsAg ) ( Kaplan-Meier estimates of cumulative clearance rates at five years , 56.0 percent for HBeAg and 11.6 percent for HBsAg ) . Of the 53 untreated patients , only 7 spontaneously eliminated HBeAg ( 28.1 percent at five years ) , and all remained positive for HBsAg ( p < 0.001 for the Comparison with the treated patients , by the proportional-hazards model ) . During follow-up , 6 of the 103 treated patients died of liver failure , and 2 needed liver transplantation , all 8 were persistently positive for HBeAg . In another eight treated patients , complications of cirrhosis developed ; all but one of these patients remained positive for HBeAg . Overall survival and survival without clinical complications were significantly longer in patients who were seronegative for HBeAg after therapy with interferon alfa than in those who remained seropositive ( P = 0.004 and P = 0.018 , respectively ) . In a regression analysis , clearance of HBeAg was the strongest predictor of survival . Of the 53 untreated patients , 13 had severe complications ( including 4 deaths and 1 need for liver transplantation ) ; all 13 continued to be HBeAg-positive . CONCLUSIONS In patients with chronic hepatitis B infection , the clearance of HBeAg after treatment with interferon alfa is associated with improved clinical outcomes Sixty-five adult asymptomatic chronic carriers of hepatitis B virus were enrolled to the r and omized controlled efficacy study of Phyllanthus amarus . Thirty-four received Phyllanthus amarus 600 mg per day for 30 days and 31 received placebo in identical capsules . The conversion rate of HBsAg was 6 per cent in the study group at day 30 . When 20 subjects in the Phyllanthus amarus group were given a further 30-day treatment and 22 placebo recipients given Phyllanthus amarus 1,200 mg per day for 30 days , the conversion was observed in 1 ( 5 % ) in the higher dose group . Adverse effects were not observed in all patients receiving the plant . The results indicated that Phyllanthus amarus , whole plant except root , grown in the central part of Thail and , given at the studied dosage and duration , had a very minimal effect on eradication of HBsAg from Thai adult asymptomatic chronic carriers Ninety Chinese hepatitis B surface antigen ( HBsAg ) carrier children , aged 2 - 17 years , positive for hepatitis B e antigen ( HBeAg ) and hepatitis B virus DNA on at least three occasions in 6 months , were r and omized into 3 groups . Thirty children received syrup vitamin B complex as control , 29 received 6 weeks of placebo syrup followed by 16 weeks of recombinant alpha 2b-interferon [ intron A ( rIFN2b ) ] , 5 x 10(6 ) u/m2 subcutaneously thrice weekly ; and 31 received 6 weeks of syrup prednisone ( 0.6 mg/kg tailed to 0.2 mg/kg ) followed by 16 weeks of recombinant alpha 2b-interferon as above . The placebo/prednisone syrup was given on a double-blind basis . At 24 months of follow-up , persistent loss of hepatitis B virus DNA occurred in none of the children in the control group , in one child receiving recombinant alpha 2b-interferon alone , who also seroconverted to anti-HBe and anti-HBs and in five children receiving interferon with steroid priming ( p = 0.0571 compared with controls ) , with four seroconverting to anti-HBe and one also seroconverting to anti-HBs . A rise of transaminases to above twice the upper limit of normal levels during the first 7 months of follow-up occurred in one subject in the control group , four in the group receiving alpha 2b-interferon alone and nine in the group receiving recombinant alpha 2b-interferon with steroid priming ( p = 0.0144 compared with controls ) . Side effects of the steroid were negligible ; those of recombinant alpha 2b-interferon were transient and acceptable . We conclude that 6 weeks of prednisone followed by 16 weeks of recombinant alpha 2b-interferon is of use in inducing persistent loss of hepatitis B virus DNA ( 16.1 per cent ) and e-seroconversion ( 12.9 per cent ) in a proportion of Chinese HBsAg carrier children : the prednisone probably enhances the immunomodulatory effect of recombinant alpha 2b-interferon Fifty percent of healthy hepatitis B surface antigen carriers may have histologically proven chronic hepatitis . Our aim was to study the benefit of interferon-alpha in healthy patients . Twenty-nine hepatitis B surface antigen carriers with normal liver enzymes and with serum hepatitis B virus DNA were r and omized into two groups : Group I , 14 patients treated with 9 megaunits of interferon alpha-2a thrice weekly for six months , and Group II , 15 control patients . A liver biopsy was obtained from each patient at study initiation . A second biopsy was available in nine treated patients and six controls . During treatment , a significant increase in alanine amino transferase levels was observed in treated patients as compared with the controls ( P < 0.05 ) . After treatment , transaminase levels decreased to normal values . No differences between treated and control patients were observed in clearance of hepatitis B virus markers . A significant increase in the total histological activity index between base line and final liver biopsies was observed in treated patients ( P < 0.05 ) . It is concluded that interferon alpha treatment may induce a biochemical and histological activation of liver disease . Accordingly , interferon alpha should not be administered to healthy hepatitis B surface antigen carriers , at least with the schedule used in this work Many r and omised controlled trials have been conducted in China to evaluate the effectiveness of traditional Chinese medicine , but much of the information is inaccessible to Western doctors . We estimated the total number of r and omised controlled trials published in China and identified problems in applying such methodology to the evaluation of traditional Chinese medicine , which would serve as preparatory work for systematic review and dissemination of the r and omised evidence for such medicine . We r and omly selected 28 journals using stratified sampling from a total of 100 Chinese journals of traditional Chinese medicine ( 4 national , 10 university , 10 provincial or regional , and 4 specialist journals ) . After special training , eight fifth year medical students ( working in pairs ) h and search ed all the issues of the journals published before 1 January 1997 to identify r and omised controlled trials . Discrepancies were settled by one of the principal investigators ( S-YZ ) . Data on method ological quality of r and omised controlled trials were extracted from 414 full length articles To examine the long‐term effect of interferon ( IFN ) therapy in patients with chronic hepatitis B virus ( HBV ) infection , particularly on survival and hepatocellular carcinoma ( HCC ) prevention , 101 male patients with chronic hepatitis B in a r and omized controlled trial were followed up for 1.1 to 11.5 years after the end of therapy . Of the 101 patients , 34 patients received a placebo ( control ) , and 67 patients were treated with IFN ( 31 patients were treated with IFN alone and 36 patients were treated with IFN after prednisolone priming ) . Follow‐up studies included clinical , biochemical , and virological aspects and HCC screening every 3 to 6 months . Twenty‐eight ( 42 % ) of the 67 IFN‐treated patients and 8 ( 24 % ) of the 34 untreated patients seroconverted by the end of the trial . During follow‐up , 22 ( 56 % ) of the 39 patients who did not seroconvert in the treated group and 5 ( 19 % ) of the 26 patients who did not seroconvert in the control group showed a delayed sustained response ( P < .005 ) . The cumulative incidence of sustained response was highest in the steroid priming group ( P = .049 vs. the IFN – alone group;P = .028 vs. the control group ) . HCC was detected in 1 ( 1.5 % ) of the 67 treated patients and 4 ( 12 % ) of the 34 untreated patients ( P = .043 ) . The interval between entry and HCC detection was 3.5 to 8.2 years . The cumulative incidence of HCC development was significantly higher in the control group than in the treated group ( P = .013 ) . In contrast , the cumulative survival rate was higher in the treated group than the control group ( P = .018 ) . Multivariate analysis showed that IFN therapy , preexisting cirrhos \n Output:\n " }, { "from": "agent", "value": "Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo .\nAnalysis of pooling eight r and omised clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers .\nREVIEW ER 'S CONCLUSIONS Based on one low quality trial , the medicinal herb ' Jianpi Wenshen recipe ' may have an antiviral activity in asymptomatic carriers of hepatitis B virus ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Between May 1986 and February 1988 , 57 patients were accrued to the second dose level of a Phase I/II Pediatric Oncology Group ( POG ) study exploring the use of hyperfractionated radiation therapy ( HRT ) in children with high‐risk brain stem tumors . Local fields were treated with fraction sizes of 117 cGy given twice daily , with a minimum interfraction interval of 6 hours , to a total dose of 7020 cGy in 60 fractions over 6 weeks . Information regarding clinical status during HRT was available for 55 patients ( 44 [ 80 % ] improved , 6 remained stable , and 5 deteriorated ) . Results of initial and follow‐up computed tomography ( CT ) scan and /or magnetic resonance imaging ( MRI ) were available for review for 52 patients . One patient had a complete response ( CR ) to treatment , 3 had a partial response ( PR ) ( more than 50 % response ) , and 40 remained stable , for a total response rate ( CR + PR + stable ) of 77 % . Median time to disease progression was 6 months . Median survival time was 10 months . Survival rate was 39.6 % ( st and ard error [ SE ] = 6.6 % ) at 1 year and 23 % ( SE = 5.8 % ) at 2 years . Complications of treatment included an enhanced skin reaction in six patients and otitis media and /or externa in nine . One patient bled into tumor shortly after completion of HRT , and three had intralesional necrosis . Five patients continued taking steroids for protracted periods in the face of improved clinical and /or radiologic findings . Complications related to the use of steroids included opportunistic infections , impaired glucose tolerance , hypertension , osteoporosis , and significant mood changes . In no patient was there evidence of any late injury attributable to HRT . When compared with results of treatment with HRT at a lower dose level ( 6600 cGy ) , there appears to be a trend toward improved survival at 7020 cGy despite a less favorable patient population at the higher dose level . A second dose escalation to 7560 cGy in 60 fractions over 6 weeks has been implemented as planned BACKGROUND The pediatric diffuse intrinsic pontine glioma ( DIPG ) outcome remains dismal despite multiple therapeutic attempts . PURPOSE To compare the results of treatment of pediatric diffuse intrinsic pontine glioma ( DIPG ) using hypofractionated versus conventional radiotherapy . PATIENTS AND METHODS Seventy-one newly diagnosed DIPG children were r and omized into hypofractionated ( HF ) ( 39Gy/13 fractions in 2.6weeks ) and conventional ( CF ) arm ( 54Gy/30 fractions in 6weeks ) . RESULTS The median and one-year overall survival ( OS ) was 7.8months and 36.4±8.2 % for the hypofractionated arm , and 9.5 and 26.2±7.4 % for the conventional arm respectively . The 18-month OS difference was 2.2 % . The OS hazard ratio ( HR ) was 1.14 ( 95 % CI : 0.70 - 1.89 ) ( p=0.59 ) . The hypofractionated arm had a median and one-year progression-free survival ( PFS ) of 6.6months and 22.5±7.1 % , compared to 7.3 and 17.9±7.1 % for the conventional arm . The PFS HR was 1.10 ( 95 % CI : 0.67 - 1.90 ) ( p=0.71 ) . The 18-month PFS difference was 1.1 % . These differences exceed the non-inferiority margin . The immediate and delayed side effects were not different in the 2 arms . CONCLUSIONS Hypofractionated radiotherapy offers lesser burden on the patients , their families and the treating departments , with nearly comparable results to conventional fractionation , though not fulfilling the non-inferiority assumption This multicenter phase I study aim ed to establish the recommended dose ( RD ) of the epidermal growth factor receptor ( EGFR ) inhibitor erlotinib , given as monotherapy or with radiotherapy to children with malignant brain tumors . Group 1 included patients with refractory or relapsing brain tumors receiving erlotinib alone , and group 2 included newly diagnosed patients with brainstem gliomas receiving radiotherapy and erlotinib . A conventional 3 + 3 dose escalation and a continual re assessment method , respectively , were utilized in 4 dose levels : 75 , 100 , 125 , and 150 mg/m² per day . Fifty-one children were enrolled ( 30 and 21 , respectively ) ; 50 received treatment . The RD of erlotinib was 125 mg/m² per day as monotherapy or in combination with radiotherapy . Overall , 230 adverse events in 44 patients were possibly treatment related ( 216 , grade s 1 and 2 ; 9 , grade 3 ; 1 , grade 4 ; 4 , grade 5 ) . Dermatologic and neurologic symptoms were common ; intratumoral hemorrhage was confirmed in 3 patients . In group 1 , 8 of 29 patients ( 28 % ) had stable disease with tumor regression approaching 50 % in a malignant glioma and an anaplastic oligoastrocytoma . In group 2 , overall survival was 12.0 months . EGFR overexpression by immunohistochemistry was found in 17 of 38 ( 45 % ) tumor sample s analyzed , with a partial gain of 7p11.2 in 1 glioblastoma ; phosphate and tensin homolog loss was frequent in brainstem glioma ( 15 of 19 ) . Mean ( 95 % CI ) apparent clearance and volume of distribution for erlotinib were 4.0 L/h ( 3.4 - 4.5 L/h ) and 98.6 L ( 69.8 - 127.0 L ) , respectively , and were independent of the dose level ; mean half-life was 16.6 hours . Thus , erlotinib 125 mg/m² per day has an acceptable tolerability profile in pediatric patients with brain tumors and can be combined with radiotherapy This phase II study was design ed to assess the safety and efficacy of gefitinib given with and following radiation therapy in children newly diagnosed with a poor prognosis brainstem glioma . Eligible patients were those with a previously untreated nondisseminated diffuse intrinsic brainstem glioma . Histological confirmation was not required , provided patients had a characteristic clinical history and MRI findings . Treatment consisted of gefitinib , administered orally , 250 mg/m(2)/day , during st and ard external beam radiotherapy , continuing for up to 13 monthly courses in the absence of disease progression or unacceptable toxicity . Toxicities , particularly intratumoral hemorrhage , were monitored . Pharmacokinetics and investigational imaging studies were performed in consenting patients . Forty-three eligible patients were included in the study . Therapy was well tolerated ; only 4 patients were withdrawn from the study for dose-limiting toxicity after receiving therapy for 6 , 9 , 17 , and 24 weeks . The 12- and 24-month progression-free survival rates were 20.9 ±5.6 % and 9.3 ±4 % , respectively . Overall survival rates were 56.4 ±7.6 % and 19.6 ±5.9 % , respectively , which appear nominally superior to other contemporaneous Pediatric Brain Tumor Consortium trials . Three patients remain progression-free survivors with ≥36 months follow-up . The observation that a subset of children with this generally fatal tumor experienced long-term progression-free survival , coupled with recent observations regarding the molecular features of brainstem gliomas , raises the possibility that prospect i ve molecular characterization may allow enrichment of treatment responders and improvement in outcome results in future studies of biologically targeted agents The purpose of this study is to evaluate the efficacy and toxicity of radiation therapy ( RT ) with concurrent temozolomide ( TMZ ) chemotherapy followed by adjuvant TMZ in children with diffuse intrinsic pontine glioma ( DIPG ) . Newly diagnosed patients younger than 18 years with histologically proven DIPG were treated with focal radiotherapy to a dose of 54 Gy in 30 fractions along with concurrent daily TMZ ( 75 mg/m2/day ) . Four weeks after completing the initial RT – TMZ schedule , adjuvant TMZ ( 200 mg/m2/day , days 1–5 ) was given every 28 days up to six cycles . Responses/progressions were assessed by clinical and 2-monthly MRI follow-up studies . Between September 2005 and September 2009 , 21 patients with newly diagnosed histologically confirmed DIPG were eligible for this study . Median age at diagnosis was 6.4 years ( range 4–16 years ) . At last up date in August 2010 , 17 children have died , 1 child was alive with progressive disease and 3 with stable disease . Metastatic relapse was documented in the cerebral site in two patients and in spinal cord in two cases . The median time to progression was 7.5 months ( range 28 days–14.5 months ) and the median survival was 11.7 months ( range 26 days–17.5 months ) . The 1-year PFS and the 1-year OS were 33 and 50 % , respectively . Five patients presented radiological findings compatible with pseudoprogression during the treatment . Haematological toxicity ( Grade III/IV thrombocytopenia and leucopenia ) was the most commonly found and led to dose reductions of TMZ in 58 % of the patients . TMZ with radiation therapy has not yielded any significant improvement in outcome of children with DIPG and is associated with higher toxicity compared with radiotherapy alone . Novel treatment modalities are needed to improve the outcome of these patients PURPOSE In September 1984 , the Pediatric Oncology Group began accrual to a Phase I/II study design ed to assess the efficacy and toxicity of sequentially escalated doses of hyperfractionated ( twice daily ) radiotherapy in children with poor-prognosis brain stem tumors . Pediatric Oncology Group Study # 8495 closed in June 1990 with a total of 136 patients on study . We report here the outcome of patients treated at the third and final dose level ( 75.6 Gy ) , and compare the results to those obtained at the 66 and 70.2 Gy dose levels . METHODS AND MATERIAL S Patients eligible for study were those between 3 and 21 years of age with previously untreated tumors arising in the midbrain , pons or medulla . Histological confirmation of diagnosis was not m and atory provided that the clinical and radiological findings were typical for brain stem glioma . Treatment consisted of radiotherapy delivered to local fields . At the third dose level , fraction sizes of 1.26 Gy were given twice daily , with a minimum interfraction interval of 6 hr to a dose of 75.6 Gy in 60 fractions over 6 weeks . Between 5/89 and 6/90 , 41 patients were accrued to the study . Two were excluded from analysis leaving 39 evaluable patients , 21 male and 19 female , whose ages ranged from 3 to 15 years ( median 7.5 years ) . RESULTS Following treatment , neurological improvement was reported in 30/39 ( 77 % ) of the patients . On central review of imaging studies in 29 patients , one patient was found to have had a complete response to radiotherapy , five a partial ( > 50 % response ) , and only three had non-responding or progressive disease . The median time to disease progression was 7 months ; median survival time was 10 months ; survival at 1 year was 39.9 % ( SE 8.3 % ) and at 2 years , 7 % ( SE 4.8 % ) . The pattern of failure was local in all patients ; in addition six had evidence of leptomeningeal seeding . Morbidity of treatment included an enhanced skin reaction ( 21 % ) , otitis media and /or externa ( 26 % ) , and steroid use > 3 months ( 62 % ) . Intralesional necrosis was a frequent finding ( 45 % ) on imaging studies performed at a median time of 6 weeks post treatment . CONCLUSION The results of treatment in terms of progression-free survival and overall survival are not significantly different ( at p = .55 and p = .46 , respectively ) from those obtained at the two previous dose levels . There is no evidence that higher doses of hyperfractionated radiotherapy given as in this study improve the outlook of patients with poor-risk brain stem gliomas Background . Fewer than 20 % of children with intrinsic brain stem tumors survive longer than 2 years . Although some improvement has been noted in recent trials using higher doses of hyperfractionated radiation therapy ( HRT ) , the feasibility of pre‐irradiation chemotherapy has not been explored in these patients with poor prognosis Background . Brain stem gliomas remain the childhood brain tumors most resistant to treatment . Treatments with hyperfractionated radiotherapy at doses as high as 7560 cGy have been fairly well tolerated . This study was undertaken to determine the toxicity and possible efficacy of hyperfractionated radiotherapy in children with brain stem gliomas using 100 cGy of radiation twice daily , to a total dose of 7800 c \n Output:\n " }, { "from": "agent", "value": "The mainly observed adverse effect was local erythema and dry desquamation especially behind the auricles .\nThere were some other toxicities , but there was no statistically significant difference between treatment groups .\nWe judged the quality of evidence to be moderate ( i.e. further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate ) for OS , and low for PFS and toxicities ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The optimal retreatment strategy for patients chronically infected with hepatitis C virus who experience virologic failure after treatment with direct‐acting antiviral – based therapies remains unclear . In this multicenter , open‐label , phase 2 study , we evaluated the efficacy and safety of a fixed‐dose combination of sofosbuvir‐velpatasvir ( 400 mg/100 mg ) plus weight‐adjusted ribavirin administered for 24 weeks in patients who did not achieve sustained virologic response after prior treatment with direct‐acting antiviral regimens that included the nucleotide analogue nonstructural protein 5B inhibitor sofosbuvir plus the nonstructural protein 5A inhibitor velpatasvir with or without the nonstructural protein 3/4A protease inhibitor voxilaprevir . The primary efficacy endpoint was the proportion of patients achieving sustained virologic response at 12 weeks after the cessation of treatment . In total , 63 of 69 ( 91 % ; 95 % confidence interval , 82%‐97 % ) patients achieved sustained virologic response at 12 weeks , including 36 of 37 ( 97 % ; 95 % confidence interval , 86%‐100 % ) patients with hepatitis C virus genotype 1 infection , 13 of 14 ( 93 % ; 95 % confidence interval , 66%‐100 % ) patients with genotype 2 infection , and 14 of 18 ( 78 % ; 95 % confidence interval , 52%‐94 % ) patients with genotype 3 infection . Most adverse events were of mild or moderate severity . The most frequently reported adverse events were fatigue , nausea , headache , insomnia , and rash . One patient ( 1 % ) with genotype 1a infection discontinued all study drugs due to an adverse event ( irritability ) . Conclusion : Retreatment of patients who previously failed direct‐acting antiviral – based therapies with sofosbuvir‐velpatasvir plus ribavirin for 24 weeks was well tolerated and effective , particularly those with hepatitis C virus genotype 1 or 2 infection . ( Hepatology 2017;66:1083‐1089 ) BACKGROUND Interferon-based treatment is not suitable for many patients with hepatitis C virus ( HCV ) infection because of contraindications such as psychiatric illness , and a high burden of adverse events . We assessed the efficacy and safety of an interferon-free regimen -- a fixed-dose combination of the nucleotide polymerase inhibitor sofosbuvir ( 400 mg ) and the HCV NS5A inhibitor ledipasvir ( 90 mg ) , with and without ribavirin -- in patients with genotype-1 hepatitis C infection who were treatment-naive or previously treated with a protease-inhibitor regimen . METHODS For this open-label study , we enrolled 100 adult patients ( > 18 years ) with HCV infection at a centre in the USA between Nov 2 , 2012 , and Dec 21 , 2012 . In cohort A , we used a computer-generated sequence to r and omly assign ( 1:1:1 ; stratified by HCV genotype [ 1a vs 1b ] ) 60 non-cirrhotic , treatment-naive patients to receive sofosbuvir plus ledipasvir for 8 weeks ( group 1 ) , sofosbuvir plus ledipasvir and ribavirin for 8 weeks ( group 2 ) , or sofosbuvir plus ledipasvir for 12 weeks ( group 3 ) . In cohort B , we r and omly allocated ( 1:1 ; stratified by genotype and presence or absence of cirrhosis ) 40 patients who previously had virological failure after receiving a protease inhibitor regimen to receive sofosbuvir plus ledipasvir for 12 weeks ( group 4 ) or sofosbuvir plus ledipasvir and ribavirin for 12 weeks ( group 5 ) . 22 ( 55 % ) of 40 patients in cohort B had compensated cirrhosis . The primary endpoint was sustained virological response 12 weeks after treatment ( SVR12 ) , analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT01329978 . FINDINGS In cohort A , SVR12 was achieved by 19 ( 95 % ) of 20 patients ( 95 % CI 75 - 100 ) in group 1 , by 21 ( 100 % ) of 21 patients ( 84 - 100 ) in group 2 , and by 18 ( 95 % ) of 19 patients ( 74 - 100 ) in group 3 . In cohort B , SVR12 was achieved by 18 ( 95 % ) of 19 patients ( 74 - 100 ) in group 4 and by all 21 ( 100 % ) of 21 patients ( 84 - 100 ) in group 5 . Two patients had viral relapse ; one patient was lost to follow-up after achieving sustained virological response 8 weeks after treatment . The most common adverse events were nausea , anaemia , upper respiratory tract infection , and headache . One patient in group five had a serious adverse event of anaemia , thought to be related to ribavirin treatment . INTERPRETATION These findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV , irrespective of treatment history or the presence of compensated cirrhosis . Further clinical trials are needed to establish the best treatment duration and to further assess the contribution of ribavirin . FUNDING Gilead Sciences BACKGROUND The once-daily , ribavirin-free , pangenotypic , direct-acting antiviral regimen , glecaprevir coformulated with pibrentasvir , has shown high rates of sustained virological response in phase 2 and 3 studies . We aim ed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus ( HCV ) infection and compensated cirrhosis . METHODS We did this single-arm , open-label , multicentre phase 3 study at 40 sites in Belgium , Canada , Germany , South Africa , Spain , and the USA . We enrolled patients aged 18 years or older with HCV genotype 1 , 2 , 4 , 5 , or 6 infection and compensated cirrhosis . Patients were either HCV treatment-naive or had not responded to treatment with interferon or pegylated interferon with or without ribavirin , or sofosbuvir plus ribavirin with or without pegylated interferon . Oral glecaprevir ( 300 mg ) coformulated with pibrentasvir ( 120 mg ) was administered once daily for 12 weeks . The primary efficacy endpoint was sustained virological response at post-treatment week 12 ( HCV RNA < 15 IU/mL ) . We assessed efficacy and safety in all patients who received at least one dose of study drug ( intention-to-treat population ) . This study is registered with Clinical Trials.gov , number NCT02642432 . FINDINGS Between Dec 7 , 2015 , and May 4 , 2016 , we enrolled 146 patients with compensated cirrhosis , of whom 48 ( 33 % ) had genotype 1a HCV infection , 39 ( 27 % ) had genotype 1b infection , 34 ( 23 % ) had genotype 2 infection , 16 ( 11 % ) had genotype 4 infection , two ( 1 % ) had genotype 5 infection , and seven ( 5 % ) had genotype 6 infection . 12 weeks after treatment , 145 patients ( 99 % , 95 % CI 98 - 100 ) achieved sustained virological response , with one ( 1 % ) relapse at post-treatment week 8 . We recorded 101 ( 69 % ) adverse events , of which 65 ( 64 % ) were mild . The most common adverse events were fatigue ( n=28 [ 19 % ] ) and headache ( n=20 [ 14 % ] ) . 11 ( 8 % ) patients had serious adverse events , none of which were deemed related to study drugs . No patients had elevations in alanine aminotransferase and no patients prematurely discontinued treatment because of adverse events . INTERPRETATION Our results show that 99 % of patients treated with once-daily glecaprevir plus pibrentasvir achieved a sustained virological response at 12 weeks . Furthermore , this drug regimen had a favourable safety profile in previously treated or untreated patients with chronic HCV genotype 1 , 2 , 4 , 5 , or 6 infection and compensated cirrhosis . These findings could help simplify treatment algorithms and reduce treatment burden . FUNDING AbbVie Glecaprevir ( nonstructural protein 3/4A protease inhibitor ) and pibrentasvir ( nonstructural protein 5A inhibitor ) ( G/P ) , a coformulated once‐daily , all oral , ribavirin (RBV)‐free , direct‐acting antiviral regimen , was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Japanese patients , including those with compensated cirrhosis . CERTAIN‐2 is a phase 3 , open‐label , multicenter study assessing the safety and efficacy of G/P ( 300/120 mg ) once daily in treatment‐naive and interferon ± RBV treatment – experienced Japanese patients without cirrhosis but with GT2 infection . Patients were r and omized 2:1 to receive 8 weeks of G/P ( arm A ) or 12 weeks of sofosbuvir ( 400 mg once daily ) + RBV ( 600‐1000 mg weight‐based , twice daily ) ( arm B ) . The primary endpoint was noninferiority of G/P compared to sofosbuvir + RBV by assessing sustained virologic response at posttreatment week 12 ( SVR12 ) among patients in the intent‐to‐treat population . SVR12 was also assessed in treatment‐naive and interferon ± RBV treatment‐experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the CERTAIN‐1 study . A total of 136 patients were enrolled in CERTAIN‐2 . SVR12 was achieved by 88/90 ( 97.8 % ) patients in arm A and 43/46 ( 93.5 % ) patients in arm B. No patient in arm A experienced virologic failure , while 2 did in arm B. The primary endpoint was achieved . In CERTAIN‐1 , 100 % ( 18/18 ) of GT2‐infected patients with compensated cirrhosis achieved SVR12 . Treatment‐emergent serious adverse events were experienced by 2 patients without cirrhosis in each arm and no patient with cirrhosis . Conclusion : The results demonstrate high efficacy and favorable tolerability of G/P in GT2‐infected Japanese patients . ( Hepatology 2018;67:505‐513 ) The phase 2 , open-label ACCORDION ( Clinical Trials.gov : NCT02349048 ) study investigated the efficacy , safety and pharmacokinetics of a 6- or 8-week regimen of simeprevir , daclatasvir and sofosbuvir in treatment-naïve patients with chronic hepatitis C virus ( HCV ) genotype ( GT ) 1 infection and either early-stage fibrosis or compensated cirrhosis . Patients were assigned to treatment groups according to their fibrosis stage . Early-stage fibrosis : simeprevir 150 mg , daclatasvir 60 mg , sofosbuvir 400 mg once daily for 6 weeks ; compensated cirrhosis : same regimen for 8 weeks . The primary endpoint was sustained virologic response 12 weeks after the end of treatment ( SVR12 ) . Safety , tolerability and pharmacokinetics of simeprevir , daclatasvir and sofosbuvir were investigated . Sixty-eight patients were treated ( 6-week group : n = 59 ; 8-week group : n = 9 ) . SVR12 was achieved by 86.4 % ( 51/59 ) of patients with early-stage fibrosis and by 100 % ( 9/9 ) of patients with cirrhosis . The main reason for not achieving SVR12 in the 6-week group was viral relapse ( 11.9 % ; 7/59 ) . One patient had on-treatment failure due to an early withdrawal ( lost to follow-up due to incarceration ) . One patient with SVR12 in the 6-week group had a late viral relapse at post-treatment week 24 . No clinical ly significant drug-drug interactions were observed . Adverse events were reported in 63.2 % of patients ( 43/68 ) and were mainly grade 1/2 . None of these led to treatment discontinuation . The 3 direct-acting antiviral regimens of simeprevir , daclatasvir and sofosbuvir were safe and well tolerated in treatment-naïve , HCV GT1-infected patients \n Output:\n " }, { "from": "agent", "value": "Personalised strategies ( 100 % vs 87.6 % ; p<0.001 ) and therapy shortened according to ≥3 host/viral factors ( 92.9 % vs 81.4 % or 87.2 % for 1 or 2 host/viral factors , respectively ; p=0.008 ) offer higher SVR rates when shortening therapy .\nConclusions : Treatment optimisation for individuals with multiple predictors of treatment failure can offer high SVR rates ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background In the present study , Interceptor ® , long-lasting polyester net , 75 denier and bursting strength of minimum 250 kPa coated with alpha-cypermethrin @ 200 mg/m2 was evaluated for its efficacy in reducing the mosquito density , blood feeding inhibition and malaria incidence in a tribal dominated malaria endemic area in Chhattisgarh state , central India . Its durability , washing practice s and usage pattern by the community was also assessed up to a period of three years . Methods The study was carried out in two phases . In the first phase ( September 2006 to August 2007 ) , 16 malaria endemic villages in district Kanker were r and omized into three groups , viz . Interceptor net ( LN ) , untreated polyester net ( 100 denier ) and without net . Malaria cases were detected by undertaking fortnightly surveillance by home visits and treated as per the national drug policy . Mosquito collection s were made by h and catch and pyrethrum space spray methods from human dwellings once every month . Slide positivity rate ( SPR ) and malaria incidence per 1000 population ( PI ) were compared between the three study arms to assess the impact of use of Interceptor nets . Simultaneously , wash resistance studies were carried out in the laboratory by doing cone bioassays on Interceptor LNs washed up to 20 times . Activities undertaken in second Phase ( April 2008 to October 2009 ) after an interval of about 18 months post-net distribution included question naire based surveys at every six months , i.e. 18 , 24 , 30 and 36 months to observe durability , usage pattern of LNs and washing practice s by the community . After 36 months of field use , 30 nets were retrieved and sample d destructively for chemical analysis . Results Interceptor nets were found effective in reducing the density , parity rate and blood feeding success rate of main malaria vector Anopheles culicifacies as compared to that in untreated net and no net villages . SPR in LN villages was 3.7 % as compared to 6.5 % in untreated and 11 % in no net villages . PI in LN villages was 16.4 in comparison to 24.8 and 44.2 in untreated polyester net and no net villages respectively . In surveys carried out after three years of initial distribution , 78.7 % ( 737/936 ) nets were still in possession with the households , of which 68 % were used every night . An . culicifacies mortality was > 80 % in cone bioassays done on LNs washed up to 20 times in laboratory . Mean alpha-cypermethrin content was 43.5 ± 31.7 mg/m2 on Interceptor LNs withdrawn after three years of household use against the baseline specification of 200 mg/m2 . A gradual increase in the proportion of holed nets was observed with the increased period of usage . Conclusion Interceptor nets were highly effective in reducing vector densities as well as malaria incidence in the study villages . Availability of 78 % nets with the households in usable condition clearly indicated durability of Interceptor LNs up to three years in the rural setting of India . The nets were found to contain an effective concentration of alpha-cypermethrin against malaria vector after three years of household use Objective Systematic review s can include cluster-r and omised controlled trials ( C- RCTs ) , which require different analysis compared with st and ard individual-r and omised controlled trials . However , it is not known whether review authors follow the method ological and reporting guidance when including these trials . The aim of this study was to assess the method ological and reporting practice of Cochrane review s that included C- RCTs against criteria developed from existing guidance . Methods Criteria were developed , based on method ological literature and personal experience supervising review production and quality . Criteria were grouped into four themes : identifying , reporting , assessing risk of bias , and analysing C- RCTs . The Cochrane Data base of Systematic Review s was search ed ( 2nd December 2013 ) , and the 50 most recent review s that included C- RCTs were retrieved . Each review was then assessed using the criteria . Results The 50 review s we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013 . For identifying C- RCTs , only 56 % identified that C- RCTs were eligible for inclusion in the review in the eligibility criteria . For reporting C- RCTs , only eight ( 24 % ) of the 33 review s reported the method of cluster adjustment for their included C- RCTs . For assessing risk of bias , only one review assessed all five C- RCT -specific risk-of-bias criteria . For analysing C- RCTs , of the 27 review s that presented unadjusted data , only nine ( 33 % ) provided a warning that confidence intervals may be artificially narrow . Of the 34 review s that reported data from unadjusted C- RCTs , only 13 ( 38 % ) excluded the unadjusted results from the meta-analyses . Conclusions The method ological and reporting practice s in Cochrane review s incorporating C- RCTs could be greatly improved , particularly with regard to analyses . Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic review s incorporating C- RCTs Malaria vector mosquitoes belonging to the Anopheles gambiae complex were studied in four hamlets in The Gambia . All inhabitants were given bednets treated either with a placebo ( milk ) in two hamlets or with the pyrethroid insecticide permethrin ( 500 mg/m2 ) in two other hamlets . Malaria transmission occurred mainly during a few weeks of the rainy season , in September and October 1987 . The indoor resting densities of mosquitoes in permethrin-treated hamlets were reduced , and we estimated over 90 % reduction in biting on man by An . gambiae Giles sensu stricto in these hamlets . No mosquitoes were found under permethrin-treated bednets compared with eighty-one recovered from placebo-treated bednets . Mosquitoes exited more readily from rooms where permethrin-treated bednets were used than from rooms with placebo-treated nets . The annual mean probability that a child would receive an infective bite was estimated to be 0.09 in hamlets with insecticide-treated bednets , compared with 1.9 where placebo-treated bednets were used . Permethrin-treated bednets are therefore recommended as a means of effectively reducing the risk of exposure to malaria transmission , particularly in areas of low seasonal transmission A group-r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) was conducted in an area of high perennial malaria transmission in western Kenya to test the effect of ITNs on all-cause mortality in children 1 - 59 months of age . Child deaths were monitored over a two-year period by biannual household census in Asembo ( 1997 - 1998 ) and in Gem ( 1998 - 1999 ) . Overall , 1,722 deaths occurred in children 1 - 59 months followed for 35,932 child-years . Crude mortality rates/1,000 child-years were 51.9 versus 43.9 in control and ITN villages in children 1 - 59 months old . The protective efficacy ( PE ) ( 95 % confidence interval ) adjusted for age , study year , study site , and season was 16 % ( 6 - 25 % ) . Corresponding figures in 1 - 11- and 12 - 59-month-old children in control and ITN villages were 133.3 versus 102.3 , PE = 23 % ( 11 - 34 % ) and 31.1 versus 28.7 , PE = 7 % ( -6 - 19 % ) . The numbers of lives saved/1,000 child-years were 8 , 31 , and 2 for the groups 1 - 59 , 1 - 11 , and 12 - 59 months old , respectively . Stratified analysis by time to insecticide re-treatment showed that the PE of ITNs re-treated per study protocol ( every six months ) was 20 % ( 10 - 29 % ) , overall and 26 % ( 12 - 37 % ) and 14 % ( -1 - 26 % ) in 1 - 11- and 12 - 59-month-old children , respectively . ITNs prevent approximately one in four infant deaths in areas of intense perennial malaria transmission , but their efficacy is compromised if re-treatment is delayed beyond six months A field trial was conducted on the efficacy of Interceptor nets-a long-lasting insecticidal net ( LLN ) factory treated with alphacypermethrin 0.667 % ( w/w ) corresponding to 200mg/m(2 ) , against malaria vectors Anopheles culicifacies and Anopheles fluviatilis in one of the highly endemic areas of Orissa . The study area comprised 19 villages which were r and omized into three clusters and design ated as Interceptor net cluster , untreated net cluster , and no net cluster . Baseline studies showed that both the vector species An . culicifacies and An . fluviatilis were 100 % susceptible to alphacypermethrin . Results of wash-resistance and bio-efficacy of Interceptor nets showed 100 % mortality in An . culicifacies and An . fluviatilis even after 20 washings . Bioassays on the Interceptor nets while in use in the field conditions showed a knockdown effect on 70 - 90 % mosquitoes during different months of intervention after 3 min of exposure and 100 % mortality was recorded after 24h of recovery period . The median knockdown time for these species ranged between 4.10 - 5.25 min and 4.00 - 5.00 min respectively during intervention period . In Interceptor net study area , there was a significant reduction of 88.9 , 96.3 and 90.6 % in the entry rate of An . culicifacies , An . fluviatilis and other anopheline species respectively with an over all reduction of 87.5 % in total mosquitoes . The overall feeding success rate of mosquitoes in the trial villages was only 12.8 % in comparison to 35.0 and 78.8 % in villages with untreated nets and no nets respectively . A significant reduction was also recorded in parity rate and human blood index of vector species in Interceptor net area . The results of the study showed that Interceptor nets are effective against the malaria vectors and may be used as a suitable intervention strategy in high-risk areas Spatial analyses of the effect of insecticide (permethrin)-treated bed nets ( ITNs ) on nearby households both with and without ITNs was performed in the context of a large-scale , group-r and omized , controlled mortality trial in Asembo , western Kenya . Results illustrate a protective effect of ITNs on compounds lacking ITNs located within 300 meters of compounds with ITNs for child mortality , moderate anemia , high-density parasitemia , and hemoglobin levels . This community effect on nearby compounds without nets is approximately as strong as the effect observed within villages with ITNs . This implies that in areas with intense malaria transmission with high ITN coverage , the primary effect of insecticide-treated nets is via area-wide effects on the mosquito population and not , as commonly supposed , by simple imposition of a physical barrier protecting individuals from biting . The strength of the community effect depended upon the proportion of nearby compounds with treated nets . To maximize their public health impact , high coverage with treated nets is essential Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The efficacy of nets treated with lambda-cyhalothrin , a pyrethroid insecticide , on malaria infection and disease was assessed for the first time at the community level in Anopheles gambiae pyrethroid resistance areas . The study was carried out in northern Côte d'Ivoire , which is an area of kdr resistance . Four pairs of villages were selected and matched according to demographic , sociological , and ecological criteria . Among each pair , a village was r and omly allocated to receive mosquito nets . More than 80 % of beds were covered with nets treated with lambda-cyhalothrin and retreated after 6 months . In each village , 54 children aged 0 - 59 months were r and omly selected and clinical ly monitored for 8 periods of 7 days throughout the year . Results showed that the efficacy of treated nets was maintained with a reduction of the prevalence of asymptomatic malaria infection by 12 % and an estimated protective efficacy against malaria disease of 56 % New tools to prevent malaria morbidity and mortality are needed to improve child survival in sub-Saharan Africa . Insecticide treated bednets ( ITBN ) have been shown , in one setting ( The Gambia , West Africa ) , to reduce childhood mortality . To assess the impact of ITBN on child survival under different epidemiological and cultural conditions we conducted a community r and omized , controlled trial of permethrin treated bednets ( 0.5 g/m2 ) among a rural population on the Kenyan Coast . Between 1991 and 1993 continuous community-based demographic surveillance linked to hospital-based in-patient surveillance identified all mortality and severe malaria morbidity events during a 2-year period among a population of over 11000 children under 5 years of age . In July 1 \n Output:\n " }, { "from": "agent", "value": "Authors ' conclusions Although there is some evidence that insecticide resistance frequency has some effects on mosquito mortality , it is unclear how quantitatively important this is ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Polyclonal intravenous IgG ( IVIG ) was administered as an infusion 6 times every 3 weeks ( week 0 , 3 , 6 , 9 , 12 , 15 ) in doses of 0.1 , 0.4 and 0.8 g/kg BW to determine the dose causing an increase in 12 pneumococcal antibody types above the protective level of 200 ng/ml of antibody N. The dose of 0.4 g/kg BW was found to be optimal in patients with chronic lymphocytic leukaemia ( CLL ) . From the first infusion onwards at least 80 % of CLL patients had increases in all 12 antibodies . Five weeks after the last infusion the antibody levels were still elevated in 80 % of patients with CLL . The dose of 0.8 g/kg raised all 12 antibodies in 53 - 73 % of CLL patients when assessment s were made after each infusion . In multiple myeloma ( MM ) patients , 73 - 82 % and 73 - 91 % of patients had increased antibody levels , respectively , before and after the 4th-6th infusions at the 0.8 g/kg dose level . However , in only 45 - 50 % of patients did the antibodies remain increased 2 weeks after the treatment at this dose . The dose of 0.4 g/kg caused antibody increases in only 30 - 50 % of patients when measured before the 4th-6th infusion . Serum IgG increased significantly only in the CLL patients , whereas in the MM patients it was high from the beginning owing to the disease . Therefore , the pneumococcal antibody levels were a better marker for the purpose of dose finding . The dosage recommendation in CLL is 0.4 g/kg every 3 weeks until week 12 , when steady state is reached . The maintenance dose is 0.4 g/kg every 5 weeks . In MM patients , who have a faster elimination rate of antibodies , the recommended loading dose is 0.8 g/kg , followed by 0.4 g/kg every week as a continuous treatment . Treatment with IVIG in CLL and MM was generally well tolerated . Only 25 % of patients experienced minor side-effects , the most frequent being febrile reactions , shivering and headache Patients treated with allogeneic bone marrow transplantation ( BMT ) suffer from a deficient humoral immunity during the post-transplant period . To prevent infections patients may receive prophylactic intravenous immunoglobulin ( IVIG ) therapy from 1 week before to 3 months after BMT . We have studied the effect of IVIG treatment on reconstitution of immunoglobulin repertoires in transplanted patients . Sera obtained from 13 IVIG-treated and 31 non-IVIG-treated patients before and at different time points after BMT , ranging from 3 days to 3 years , and from 18 healthy controls , were analyzed using a quantitative immunoblot system . The average immunoglobulin (Ig)M and IgG reactivity profiles against antigens derived from human liver , muscle and skin as well as Staphylococcus epidermidis protein extracts were similar in both patient groups and in controls . Both IgG and IgM reactivity profiles are , however , less heterogeneous among the individuals in the IVIG-treated patient group . Around 1 year after BMT the heterogeneity of the IgM reactivity profiles against allogeneic protein extracts is much lower in the IVIG-treated group compared to the non-IVIG-treated group and the healthy controls . This effect remains months to years after the IVIG treatment has been completed . Our results suggest that IVIG influences selection of the natural antibody repertoire mediated by the variable (V)-region during reconstitution after BMT To determine whether intravenous immunoglobulin ( IVIg ) given monthly from day 90 to day 360 posttransplantation decreased the incidence of late infection , chronic graft-vs.-host disease ( GVHD ) , and obliterative bronchiolitis after marrow transplantation , patients were assigned r and omly to receive either IVIg ( 500 mg/kg/month ) or no IVIg prophylaxis . Participants were registered before transplantation , and 250 patients ( 123 IVIg and 127 control ) were evaluable for events after day 100 . The two groups were balanced for age , marrow source , cytomegalovirus ( CMV ) seropositivity , pretransplantation conditioning , and prophylaxis for infection and GVHD . Between days 100 and 365 posttransplantation , the incidence of bacteremia or septicemia per 100 patient-days of risk was 0.10 in the IVIg group and 0.12 in the controls ( p = not significant ) . During the same period , the incidence of localized infection was marginally higher in control patients than in IVIg recipients ( 0.44 vs. 0.24 , respectively ; relative risk [ RR ] 1.46 , p < 0.07 ) . Administration of IVIg prophylaxis had no effect on survival , the incidence of obliterative bronchiolitis , severity of airflow obstruction , or the incidence or mortality of chronic GVHD . After discontinuing IVIg prophylaxis at day 360 , subsequent recovery of endogeneous humoral immunity was impaired ( serum IgG1 and IgA levels were significantly lower than controls at day 730 ) , and total infections were less common in the second year in control patients than in former IVIg recipients ( 0.12 vs 0.19 , respectively ; RR 0.61 , p = 0.03 ) . We conclude that in the absence of hypogammaglobulinemia , monthly administration of IVIg given from day 90 to 360 does not reduce late complications and may impair long-term humoral immune recovery after marrow transplantation In a study of 63 allogeneic and autologous bone marrow transplants , patients were r and omized to receive the IgM and IgA enriched intravenous immunoglobulin ( IVIG ) preparation ( Pentaglobin ) . Pentaglobin has been postulated to have anti-endotoxin properties and one of the aims of the study was to measure endotoxin levels in these patients together with the clinical sequelae of infection . The anti-endotoxin effects of Pentaglobin were found to reside in the IgM fraction . Those patients who received Pentaglobin were significantly protected from dying from infection in the first 100 days after the transplant , although it was not actually possible to document bacterial infections as the cause of death in the control patients . Peak endotoxin levels were significantly reduced ( p = 0.02 ) in those patients receiving Pentaglobin . Liver damage as assessed by liver enzyme abnormalities correlated significantly with the presence of endotoxaemia greater than 25 pg/ml and up to 70 % of pyrexial episodes were associated with endotoxaemia . Our results suggest that Pentaglobin is useful in reducing hepatic toxicity and this may be related to a reduction in endotoxaemia Overwhelming infections cause significant morbidity and mortality in the immunocompromised host . There is considerable in vitro and in vivo evidence that the immune deficient state which accompanies acute leukaemia , and , is exacerbated by intensive chemotherapy , contributes to the infection risk in these patients . The most easily documented and corrected is that of impaired humoral immunity . In order to study the clinical significance of the deficit a double blind , r and omised , placebo controlled pilot study was set up design ed to test the feasibility , efficacy and toxicity of using prophylactic intravenous immunoglobulin to prevent infective complications in this patient group . Patients received 150 mg/kg of Pentaglobin , an immunoglobulin preparation specifically enriched in IgM and IgA , on days 0 , 10 and 20 of the chemotherapy regimes . There were no adverse side effects . Patients in the placebo group had a 25 % fall in IgM level whilst IgG and IgA remained unchanged . The treatment group maintained a stable IgM and IgG concentration throughout but had a rise in IgA. There was no difference in the total number of septicaemic episodes in each group but the placebo group had an increased number of non Staphylococcal infections ( P < 0.04 ) . We conclude that intravenous Pentaglobin protects patients against a fall in IgM during induction chemotherapy for acute leukaemia and decreases the number of non Staphylococcal infections A r and omized crossover study of prophylactic immunoglobulin ( IgG ) therapy was performed in patients with chronic lymphocytic leukaemia ( CLL ) or non-Hodgkin 's lymphoma ( NHL ) . Twelve patients with hypogammaglobulinemia or a history of recurrent infections received infusions of IgG or placebo intravenously ( IV ) every 3 weeks for 1 year . They were then switched to the alternative preparation for another year . The number of serious bacterial infections was significantly less ( P = .001 ; Mainl and 's cross-over method ) in the months in which patients received IgG. Serious bacterial infections showed a trend to be associated with an IgG level less than 6.4 g/L ( P = .046 ; Fisher 's exact test ) Forty-two patients with chronic lymphocytic leukaemia ( CLL ) , serum IgG levels < 5.5 milligrams and a history of two or more recent infections , were r and omized to receive infusions of 18 g human intravenous immunoglobulin ( IVIg ) or human albumin placebo every three weeks . During the 12 month study 122 infections were documented but only four were associated with neutropenia . Ten patients ( 24 % ) with IgG levels < 3.0 milligrams experienced 65 % of the infections . In response to IVIg there were immediate and accumulative increases in serum IgG levels and an associated decrease in total and serious infections . If three further infections occurred , placebo patients were commenced on 18 g IVIg , and IVIg patients were increased to 24 g IVIg . Approximately 50 % of these cases subsequently remained infection free . The study shows the usefulness of prophylactic S and oglobulin in CLL patients with hypogammaglobulinaemia , and suggests that this may be justified in those with recurrent infections and serum IgG levels < 3 milligrams Treatment with intense myelosuppressive therapy ( including bone marrow transplantation ) has improved survival in patients with various malignant neoplasms [ 1 , 2 ] . Unfortunately , this treatment increases the incidence of infectious complications , primarily during the period of myelosuppression [ 3 ] . Various methods have been used to limit infection during myelosuppression [ 4 - 7 ] . Despite these pre caution s , bacteremia and fungemia continue to occur in at least one third of patients with sustained neutropenia . Intravenous immunoglobulin ( IVIG ) therapy prevents infections in patients with inborn B-cell deficiencies and hypogammaglobulinemia secondary to hematologic disorders such as chronic lymphocytic leukemia [ 8 - 10 ] . Intravenous immunoglobulin has also been used successfully to treat immune thrombocytopenic purpura , alloimmunity to platelets , and other immune-mediated disorders by a mechanism of immune system modulation [ 11 ] . After allogeneic bone marrow transplantation , IVIG is commonly used to prevent graft-versus-host disease [ 12 ] . During these bone marrow transplant trials , a reduction in bacterial infection was also observed in patients who were not necessarily hypogammaglobulinemic . This finding was initially reported in small anecdotal series but was later confirmed by large prospect i ve studies [ 12 - 17 ] . This effect of IVIG was observed during the pre-engraftment ( neutropenic ) and myelosuppression recovery phases . Most patients in these studies were undergoing allogeneic bone marrow transplantation , for which graft-versus-host disease and its treatment contribute to the rate of infection [ 18 ] . Intravenous immunoglobulin is not routinely used during autologous bone marrow transplantation or severely myelosuppressive therapy because prevention of graft-versus-host disease is unnecessary . Because IVIG prevents infection after allogeneic bone marrow transplantation , it might also do so in other patients undergoing intense myelosuppression and thus may serve as a general prophylactic agent for infections . Intravenous immunoglobulin is expensive and thus should not be used indiscriminately . We design ed a prospect i ve study that r and omized patients who were expected to develop severe and sustained myelosuppression to receive IVIG or no treatment . We specifically wished to determine whether IVIG could reduce the incidence of severe infections in patients with neutropenia but without allogeneic cofactors such as graft-versus-host disease . We therefore sought to determine whether the benefits of IVIG after allogeneic bone marrow transplantation occur as a direct effect of the drug or as an indirect result of a reduced incidence of graft-versus-host disease . Methods Study Design We conducted a stratified , r and omized comparison of patients who either underwent autologous bone marrow transplantation or received substantial myelosuppressive therapy for acute leukemia or other malignant conditions . The protocol and consent forms were approved by the Institutional Review Boards of the three participating institutions : Baylor University Medical Center , Dallas , Texas ; The University of Louisville , Louisville , Kentucky ; and V and erbilt University , Nashville , Tennessee . Patients were stratified for treatment ( autologous bone marrow transplantation or \n Output:\n " }, { "from": "agent", "value": "When polyvalent immunoglobulins or hyperimmune cytomegalovirus (CMV)-IVIG was compared to control for HSCT , there was no difference in all-cause mortality .\nPolyvalent immunoglobulins significantly reduced the risk for interstitial pneumonitis but increased the risk for veno-occlusive disease and adverse events .\nIn LPD , no benefit in terms of mortality IVIG could be demonstrated but there was a decrease in clinical ly and microbiologically documented infections .\nAUTHORS ' CONCLUSIONS In patients undergoing HSCT , routine prophylaxis with IVIG is not supported ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: L-Theanine is an amino acid found naturally in tea . Despite the common consumption of L-theanine , predominantly in combination with caffeine in the form of tea , only one study to date has examined the cognitive effects of this substance alone , and none have examined its effects when combined with caffeine . The present r and omised , placebo-controlled , double-blind , balanced crossover study investigated the acute cognitive and mood effects of L-theanine ( 250 mg ) , and caffeine ( 150 mg ) , in isolation and in combination . Salivary caffeine levels were co-monitored . L-Theanine increased ' headache ' ratings and decreased correct serial seven subtractions . Caffeine led to faster digit vigilance reaction time , improved Rapid Visual Information Processing ( RVIP ) accuracy and attenuated increases in self-reported ' mental fatigue ' . In addition to improving RVIP accuracy and ' mental fatigue ' ratings , the combination also led to faster simple reaction time , faster numeric working memory reaction time and improved sentence verification accuracy . ' Headache ' and ' tired ' ratings were reduced and ' alert ' ratings increased . There was also a significant positive caffeine x L-theanine interaction on delayed word recognition reaction time . These results suggest that beverages containing L-theanine and caffeine may have a different pharmacological profile to those containing caffeine alone Recent neuropharmacological research has suggested that certain constituents of tea may have modulatory effects on brain state . The bulk of this research has focused on either L-theanine or caffeine ingested alone ( mostly the latter ) and has been limited to behavioral testing , subjective rating , or neurophysiological assessment s during resting . Here , we investigated the effects of both L-theanine and caffeine , ingested separately or together , on behavioral and electrophysiological indices of tonic ( background ) and phasic ( event-related ) visuospatial attentional deployment . Subjects underwent 4 d of testing , ingesting either placebo , 100 mg of L-theanine , 50 mg of caffeine , or these treatments combined . The task involved cued shifts of attention to the left or right visual hemifield in anticipation of an imperative stimulus requiring discrimination . In addition to behavioral measures , we examined overall , tonic attentional focus as well as phasic , cue-dependent anticipatory attentional biasing , as indexed by scalp-recorded alpha-b and ( 8 - 14 Hz ) activity . We found an increase in hit rate and target discriminability ( d ' ) for the combined treatment relative to placebo , and an increase in d ' but not hit rate for caffeine alone , whereas no effects were detected for L-theanine alone . Electrophysiological results did not show increased differential biasing in phasic alpha across hemifields but showed lower overall tonic alpha power in the combined treatment , similar to previous findings at a larger dosage of L-theanine alone . This may signify a more generalized tonic deployment of attentional re sources to the visual modality and may underlie the facilitated behavioral performance on the combined ingestion of these 2 major constituents of tea OBJECTIVE L-theanine is a unique amino acid present almost exclusively in the tea plant . It possesses neuroprotective , mood-enhancing , and relaxation properties . This is a first study design ed to evaluate the efficacy and tolerability of L-theanine augmentation of antipsychotic treatment of patients with chronic schizophrenia and schizoaffective disorder . METHOD 60 patients with DSM-IV schizophrenia or schizoaffective disorder participated in an 8-week , double-blind , r and omized , placebo-controlled study . 400 mg/d of L-theanine was added to ongoing antipsychotic treatment from February 2006 until October 2008 . The outcome measures were the Positive and Negative Syndrome Scale ( PANSS ) , the Hamilton Anxiety Rating Scale ( HARS ) , the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) for neurocognitive functioning , and additional measures of general functioning , side effects , and quality of life . RESULTS 40 patients completed the study protocol . Compared with placebo , L-theanine augmentation was associated with reduction of anxiety ( P = .015 ; measured by the HARS scale ) and positive ( P = .009 ) and general psychopathology ( P < .001 ) scores ( measured by the PANSS 3-dimensional model ) . According to the 5-dimension model of psychopathology , L-theanine produced significant reductions on PANSS positive ( P = .004 ) and activation factor ( P = .006 ) scores compared to placebo . The effect sizes ( Cohen d ) for these differences ranged from modest to moderate ( 0.09 - 0.39 ) . PANSS negative and CANTAB task scores , general functioning , side effect , and quality of life measures were not affected by L-theanine augmentation . L-theanine was found to be a safe and well-tolerated medication . CONCLUSIONS L-theanine augmentation of antipsychotic therapy can ameliorate positive , activation , and anxiety symptoms in schizophrenia and schizoaffective disorder patients . Further long-term studies of L-theanine are needed to substantiate the clinical ly significant benefits of L-theanine augmentation Tea ingredients L-theanine and caffeine have repeatedly been shown to deliver unique cognitive benefits when consumed in combination . The current r and omized , placebo-controlled , double-blind , cross-over study compared a combination of L-theanine ( 97 mg ) and caffeine ( 40 mg ) to a placebo on two attention tasks and a self-report question naire before , and 10 and 60 min after consumption . The combination of L-theanine and caffeine significantly improved attention on a switch task as compared to the placebo , while subjective alertness and intersensory attention were not improved significantly . The results support previous evidence that L-theanine and caffeine in combination can improve attention Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Objective : Ingestion of the nonproteinic amino acid theanine ( 5-N-ethylglutamine ) has been shown to increase oscillatory brain activity in the so-called alpha b and ( 8 - 14 Hz ) during resting electroencephalographic recordings in humans . Independently , alpha b and activity has been shown to be a key component in selective attentional processes . Here , we set out to assess whether theanine would cause modulation of anticipatory alpha activity during selective attentional deployments to stimuli in different sensory modalities , a paradigm in which robust alpha attention effects have previously been established . Methods : Electrophysiological data from 168 scalp electrode channels were recorded while participants performed a st and ard intersensory attentional cuing task . Results : As in previous studies , significantly greater alpha b and activity was measured over parieto-occipital scalp for attentional deployments to the auditory modality than to the visual modality . Theanine ingestion result ed in a substantial overall decrease in background alpha levels relative to placebo while subjects were actively performing this dem and ing attention task . Despite this decrease in background alpha activity , attention-related alpha effects were significantly greater for the theanine condition . Conclusion : This increase of attention-related anticipatory alpha over the right parieto-occipital scalp suggests that theanine may have a specific effect on the brain 's attention circuitry . We conclude that theanine has clear psychoactive properties , and that it represents a potentially interesting , naturally occurring compound for further study , as it relates to the brain 's attentional system OBJECTIVE The aim of this study was to investigate green tea flavan-3-ol catabolism and plasma pharmacokinetic and urinary excretion by high-performance liquid chromatography with t and em mass spectrometry to evaluate their absolute bioavailability by taking into account all known and some unknown catabolites deriving from their interaction with the gastrointestinal tract and its host microflora . METHODS A feeding study was carried out in 20 healthy human volunteers who ingested 400 mL of a ready-to-drink green tea containing approximately 400 μmol of flavan-3-ols . Urine and plasma were collected for 4 and 24h , respectively , and 39 relevant catabolites were identified in these biological fluids by t and em mass spectrometry . RESULTS In biological fluids , 39 relevant flavan-3-ol catabolites were identified . In plasma , (-)-epigallocatechin-3-gallate was the only unmetabolized compound and the highest in absolute concentration compared with (-)-epigallocatechin and (-)-epicatechin conjugates . Colonic microflora-derived polyhydroxyphenyl-γ-valerolactones were by far the main urinary catabolites , averaging 10 times greater concentratin than flavan-3-ol conjugates . The calculated bioavailability was equal to 39 % and it is interesting to notice the great variability in urinary excretion of colonic metabolites among participants , probably related to differences in their own colonic microflora . CONCLUSION This study demonstrates that green tea catechins are more bioavailable than previously observed when colonic ring fission metabolites are taken into consideration . Regular consumption of ready-to-drink green tea containing flavan-3-ols allows a non-marginal exposure of the human body to these catabolites , somehow justifying the numerous beneficial actions described as linked to green tea intake \n Output:\n " }, { "from": "agent", "value": "The effects of green tea can not be attributed to a single constituent of the beverage .\nThis is exemplified in the finding that beneficial green tea effects on cognition are observed under the combined influence of both caffeine and l-theanine , whereas separate administration of either substance was found to have a lesser impact" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE A performance improvement continuing medical education ( PI CME ) activity was design ed to assist clinicians with accurately identifying and appropriately managing persistent pain in long-term care facility ( LTCF ) residents . DESIGN Volunteer LTCFs participated in a three-stage PI CME model consisting of : 1 ) baseline assessment , 2 ) implementation of practice improvement interventions , and 3 ) re assessment . Expert faculty chose performance measures and interventions for the activity . A champion was design ated ateach LTCF to collect resident charts and enter data into an online data base . SETTING Eight LTCFs located across the United States participated in the activity . PATIENTS Fifty resident charts were r and omly selected by each LTCF champion ( 25 for stage 1 and 25 for stage 3 ) ; a total of 350 charts were review ed . INTERVENTIONS In addition to a toolkit containing numerous performance improvement re sources , an in-service meeting led by an expert faculty member was conducted at each LTCF . OUTCOME MEASURES Stage 3 data were collected 6 weeks after implementation of interventions and compared with stage 1 baseline data to measure change in performance . RESULTS Aggregate data collected from seven LTCFs completing the PI CME activity through stage 3 revealed improvements from baseline in four of five performance measures . CONCLUSIONS This CME activity allowed for collection of data demonstrating performance improvement in persistent pain management . The tools used as part of the intervention ( available at http://www.achlpicme.org/LTC/toolkit ) may help other clinicians enhance their management of LTCF residents with persistent pain Background The diversity of quality improvement interventions ( QIIs ) has impeded the use of evidence review to advance quality improvement activities . An agreed-upon framework for identifying QII articles would facilitate evidence review and consensus around best practice s. Aim To adapt and test evidence review methods for identifying empirical QII evaluations that would be suitable for assessing QII effectiveness , impact or success . Design Literature search with measurement of multilevel inter-rater agreement and review of disagreement . Methods Ten journals ( 2005 - 2007 ) were search ed electronically and the output was screened based on title and abstract . Three pairs of review ers then independently rated 22 articles , r and omly selected from the screened list . Kappa statistics and percentage agreement were assessed . 12 stakeholders in quality improvement , including QII experts and journal editors , rated and discussed publications about which review ers disagreed . Results The level of agreement among review ers for identifying empirical evaluations of QII development , implementation or results was 73 % ( with a paradoxically low kappa of 0.041 ) . Discussion by raters and stakeholders regarding how to improve agreement focused on three controversial article selection issues : no data on patient health , provider behaviour or process of care outcomes ; no evidence for adaptation of an intervention to a local context ; and a design using only observational methods , as correlational analyses , with no comparison group . Conclusion The level of review er agreement was only moderate . Reliable identification of relevant articles is an initial step in assessing published evidence . Advancement in quality improvement will depend on the theory- and consensus-based development and testing of a generalizable framework for identifying QII evaluations Objective Continuous quality improvement ( CQI ) methods are foundational approaches to improving healthcare delivery . Publications using the term CQI , however , are method ologically heterogeneous , and labels other than CQI are used to signify relevant approaches . St and ards for identifying the use of CQI based on its key method ological features could enable more effective learning across quality improvement ( QI ) efforts . The objective was to identify essential method ological features for recognizing CQI . Design Previous work with a 12-member international expert panel identified reliably abstract ed CQI method ological features . We tested which features met rigorous a priori st and ards as essential features of CQI using a three-phase online modified-Delphi process . Setting Primarily United States and Canada . Participants 119 QI experts r and omly assigned into four on-line panels . Intervention(s ) Participants rated CQI features and discussed their answers using online , anonymous and asynchronous discussion boards . We analyzed ratings quantitatively and discussion threads qualitatively . Main outcome measure(s ) Panel consensus on definitional CQI features . Results Seventy-nine ( 66 % ) panelists completed the process . Thirty-three completers self-identified as QI research ers , 18 as QI practitioners and 28 as both equally . The features ‘ systematic data guided activities , ’ ‘ design ing with local conditions in mind ’ and ‘ iterative development and testing ’ met a priori st and ards as essential CQI features . Qualitative analyses showed cross-cutting themes focused on differences between QI and CQI . Conclusions We found consensus among a broad group of CQI research ers and practitioners on three features as essential for identifying QI work more specifically as ‘ CQI . ’ All three features are needed as a minimum st and ard for recognizing CQI methods BACKGROUND Challenges exist in implementing evidence -based strategies , reaching high compliance , and achieving desired outcomes . The rapid adoption of a publicly available toolkit featuring routine universal decolonization of intensive care unit ( ICU ) patients may affect catheter-related bloodstream infections . METHODS Implementation of universal decolonization-treatment of all ICU patients with chlorhexidine bathing and nasal mupirocin-used a prerelease version of a publicly available toolkit . Implementation in 136 adult ICUs in 95 acute care hospitals across the United States was supported by planning and deployment tactics coordinated by a central infection prevention team using toolkit re sources , along with coaching calls and engagement of key stakeholders . Operational and process measures derived from a common electronic health record system provided real-time feedback about performance . Healthcare-associated central line-associated bloodstream infections ( CLABSIs ) , using National Healthcare Safety Network surveillance definitions and comparing the preimplementation period of January 2011 through December 2012 to the postimplementation period of July 2013 through February 2014 , were assessed via a Poisson generalized linear mixed model regression for CLABSI events . RESULTS Implementation of universal decolonization was completed within 6 months . The estimated rate of CLABSI decreased by 23.5 % ( 95 % confidence interval , 9.8%-35.1 % ; P = .001 ) . There was no evidence of a trend over time in either the pre- or postimplementation period . Adjusting for seasonality and number of beds did not material ly affect these results . CONCLUSIONS Dissemination of universal decolonization of ICU patients was accomplished quickly in a large community health system and was associated with declines in CLABSI consistent with published clinical trial findings BACKGROUND Both targeted decolonization and universal decolonization of patients in intensive care units ( ICUs ) are c and i date strategies to prevent health care-associated infections , particularly those caused by methicillin-resistant Staphylococcus aureus ( MRSA ) . METHODS We conducted a pragmatic , cluster-r and omized trial . Hospitals were r and omly assigned to one of three strategies , with all adult ICUs in a given hospital assigned to the same strategy . Group 1 implemented MRSA screening and isolation ; group 2 , targeted decolonization ( i.e. , screening , isolation , and decolonization of MRSA carriers ) ; and group 3 , universal decolonization ( i.e. , no screening , and decolonization of all patients ) . Proportional-hazards models were used to assess differences in infection reductions across the study groups , with clustering according to hospital . RESULTS A total of 43 hospitals ( including 74 ICUs and 74,256 patients during the intervention period ) underwent r and omization . In the intervention period versus the baseline period , modeled hazard ratios for MRSA clinical isolates were 0.92 for screening and isolation ( crude rate , 3.2 vs. 3.4 isolates per 1000 days ) , 0.75 for targeted decolonization ( 3.2 vs. 4.3 isolates per 1000 days ) , and 0.63 for universal decolonization ( 2.1 vs. 3.4 isolates per 1000 days ) ( P=0.01 for test of all groups being equal ) . In the intervention versus baseline periods , hazard ratios for bloodstream infection with any pathogen in the three groups were 0.99 ( crude rate , 4.1 vs. 4.2 infections per 1000 days ) , 0.78 ( 3.7 vs. 4.8 infections per 1000 days ) , and 0.56 ( 3.6 vs. 6.1 infections per 1000 days ) , respectively ( P<0.001 for test of all groups being equal ) . Universal decolonization result ed in a significantly greater reduction in the rate of all bloodstream infections than either targeted decolonization or screening and isolation . One bloodstream infection was prevented per 54 patients who underwent decolonization . The reductions in rates of MRSA bloodstream infection were similar to those of all bloodstream infections , but the difference was not significant . Adverse events , which occurred in 7 patients , were mild and related to chlorhexidine . CONCLUSIONS In routine ICU practice , universal decolonization was more effective than targeted decolonization or screening and isolation in reducing rates of MRSA clinical isolates and bloodstream infection from any pathogen . ( Funded by the Agency for Healthcare Research and the Centers for Disease Control and Prevention ; REDUCE MRSA Clinical Trials.gov number , NCT00980980 ) CONTEXT Falls cause injury and death for persons of all ages , but risk of falls increases markedly with age . Hospitalization further increases risk , yet no evidence exists to support short-stay hospital-based fall prevention strategies to reduce patient falls . OBJECTIVE To investigate whether a fall prevention tool kit ( FPTK ) using health information technology ( HIT ) decreases patient falls in hospitals . DESIGN , SETTING , AND PATIENTS Cluster r and omized study conducted January 1 , 2009 , through June 30 , 2009 , comparing patient fall rates in 4 urban US hospitals in units that received usual care ( 4 units and 5104 patients ) or the intervention ( 4 units and 5160 patients ) . INTERVENTION The FPTK integrated existing communication and workflow patterns into the HIT application . Based on a valid fall risk assessment scale completed by a nurse , the FPTK software tailored fall prevention interventions to address patients ' specific determinants of fall risk . The FPTK produced bed posters composed of brief text with an accompanying icon , patient education h and outs , and plans of care , all communicating patient-specific alerts to key stakeholders . MAIN OUTCOME MEASURES The primary outcome was patient falls per 1000 patient-days adjusted for site and patient care unit . A secondary outcome was fall-related injuries . RESULTS During the 6-month intervention period , the number of patients with falls differed between control ( n = 87 ) and intervention ( n = 67 ) units ( P=.02 ) . Site-adjusted fall rates were significantly higher in control units ( 4.18 [ 95 % confidence interval { CI } , 3.45 - 5.06 ] per 1000 patient-days ) than in intervention units ( 3.15 [ 95 % CI , 2.54 - 3.90 ] per 1000 patient-days ; P = .04 ) . The FPTK was found to be particularly effective with patients aged 65 years or older ( adjusted rate difference , 2.08 [ 95 % CI , 0.61 - 3.56 ] per 1000 patient-days ; P = .003 ) . No significant effect was noted in fall-related injuries . CONCLUSION The use of a fall prevention tool kit in hospital units compared with usual care significantly reduced rate of falls . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00675935 BACKGROUND Since the 2008 inception of universal childhood influenza vaccination , national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent . Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70 % . PURPOSE To evaluate an intervention to increase childhood influenza vaccination across age and racial groups . METHODS In 2011 - 2012 , a total of 20 primary care practice s treating children were r and omly assigned to the intervention and control arms of a cluster r and omized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine , in-service staff meetings , and publicity . RESULTS The average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm ( n=10 practice s ) than the control arm ( n=10 practice s ) ; for children aged 9 - 18 years ( 11.1 pct pts intervention vs 4.3 pct pts control , p<0.05 ) ; for non-white children ( 16.7 pct pts intervention vs 4.6 pct pts control , p<0.001 ) ; and overall ( 9.9 pct pts intervention vs 4.2 pct pts control , p<0.01 ) . In multi-level modeling that accounted for person- and practice -level variables and the interactions among age , race , and intervention , the likelihood of vaccination increased with younger age group ( 6 - 23 months ) ; white race ; commercial insurance ; the practice 's pre-intervention vaccination rate ; and being in the intervention arm . Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination \n Output:\n " }, { "from": "agent", "value": "Studies generally indicated high satisfaction with toolkits , but the perceived usefulness of individual tools varied .\nConclusions The review documents publicly available toolkits and their components .\nHigh satisfaction with toolkits can be achieved but the usefulness of individual tools may vary ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Pediatric patients who undergo posterior spinal fusion surgery to correct scoliosis often require multiple blood transfusions . Tranexamic acid is a synthetic antifibrinolytic drug that reduces transfusion requirements in cardiac surgery and total knee arthroplasty . We evaluated the efficacy of prophylactic tranexamic acid to reduce perioperative blood transfusion requirements in a prospect i ve , double-blinded , placebo control study . Forty patients , 9–18 yr of age , were r and omized to either tranexamic acid ( initial dose of 10 mg/kg and infusion of 1 mg · kg−1 · h−1 ) or placebo ( isotonic saline ) . Perioperative management was st and ardized . A uniform transfusion threshold for noncell saved red blood cells was 7.0 g/dL. The total amount of blood transfused in the perioperative period was significantly reduced in the Tranexamic group ( P = 0.045 ) . No thrombotic complications were detected in either group . The administration of prophylactic tranexamic acid in patients with scoliosis undergoing posterior spinal fusion surgery has the potential to reduce perioperative blood transfusion requirements Background : Previous studies have noted that the use of antifibrinolytic medications can help reduce blood loss and transfusion requirements during cardiac , total joint arthroplasty , and spine surgery . Tranexamic acid ( TXA ) has been investigated in these patient groups but consensus with respect to the dosing regimen has not been achieved , especially in the pediatric scoliosis literature . The purpose of this study was to compare the effects of 2 TXA dosing regimens on reducing transfusion requirements . Methods : A retrospective chart review was performed on all idiopathic scoliosis patients undergoing posterior spinal instrumentation and fusion from 2005 to 2006 to determine total perioperative transfusion requirements . Transfusion requirements for those patients receiving either a low ( 10 mg/kg loading , 1 mg/kg/h infusion ) or high ( 20 mg/kg loading , 10 mg/kg/h infusion ) dose of TXA were compared . Results : High-dose TXA ( n = 11 ) showed a trend toward a reduction in transfusion requirements compared with the low dose ( n = 15 ) for idiopathic scoliosis patients undergoing posterior only instrumentation and fusion ( 687.9 ± 778.1 mL vs 1372.6 ± 1077.3 mL ; P = 0.07 ; 95 % confidence interval for the mean difference , −66.3 mL to 1435.7 mL ) . Although substantial , this difference was underpowered to show a difference . Conclusions : The use of the higher dose of TXA result ed in a 50 % reduction in transfusion requirements for idiopathic scoliosis patients . Given previous studies , there appears to be a dose-response effect . A prospect i ve dose-ranging study is now required to determine the optimal dose for pediatric patients with idiopathic scoliosis . Level of Evidence : III , retrospective cohort study Background : Excessive bleeding often occurs during pediatric scoliosis surgery and is attributed to numerous factors , including accelerated fibrinolysis . The authors hypothesized that administration of tranexamic acid would reduce bleeding and transfusion requirements during scoliosis surgery . Methods : Forty-four patients scheduled to undergo elective spinal fusion were r and omly assigned to receive either 100 mg/kg tranexamic acid before incision followed by an infusion of 10 mg · kg−1 · h−1 during surgery ( tranexamic acid group ) or 0.9 % saline ( placebo group ) . General anesthesia was administered according to a st and ard protocol . Blood loss , transfusion requirements , coagulation parameters , and complications were assessed . Results : In the tranexamic acid group , blood loss was reduced by 41 % compared with placebo ( 1,230 ± 535 vs. 2,085 ± 1,188 ml ; P < 0.01 ) . The amount of blood transfused did not differ between groups ( 615 ± 460 vs. 940 ± 718 ml ; P = 0.08 ) . Administration of tranexamic acid was a multivariate predictor of blood loss , as was American Society of Anesthesiologists physical status and preoperative platelet count . No apparent adverse drug effects occurred in any patient . Conclusion : Intraoperative administration of tranexamic acid significantly reduces blood loss during spinal surgery in children with scoliosis BACKGROUND Aprotinin and epsilon aminocaproic acid are antifibrinolytic agents used to reduce postoperative blood loss after cardiopulmonary bypass . We compared low dose aprotinin with epsilon aminocaproic acid and a combination of the two agents to reduce postoperative blood loss in infants with congenital cyanotic heart disease undergoing corrective surgical procedures . METHODS This prospect i ve study was conducted r and omly on 300 children . Group I ( n = 80 ) acted as the control and did not receive either of the study drugs . Group II ( n = 100 ) received low dose aprotinin , group III ( n = 60 ) received epsilon aminocaproic acid , and group IV ( n = 60 ) received a combination of the two antifibrinolytic agents . RESULTS The control group had the longest time for sternal closure , maximum blood loss at 24 hours , and greatest requirements for packed red blood cells and platelets . Fibrinogen levels were significantly lower , and levels of fibrin breakdown products were significantly higher compared with the groups given either or both of the antifibrinolytics . CONCLUSIONS Epsilon aminocaproic acid is as efficacious as low dose aprotinin in reducing postoperative blood loss and packed red blood cell and platelet requirements in children with congenital cyanotic heart disease . The combination of the two was slightly more effective UNLABELLED In this prospect i ve cohort study of 548 children undergoing open-heart surgery , we evaluated demographic and perioperative factors to identify variables associated with perioperative blood loss and blood product transfusions . Using multivariate analysis , younger patient age was found to be the variable most significantly associated with bleeding and transfusions . Higher preoperative hematocrit , complex surgery , lower platelet count during cardiopulmonary bypass ( CPB ) , and longer duration of deep hypothermic circulatory arrest were also significantly associated with bleeding and transfusion . Excessive postoperative chest tube ( CT ) drainage was associated with intraoperative bleeding . Independently associated variables accounted for 76 % of the variability in CT output measured after 2 h in intensive care . Patients were subdivided into children aged < or = 1 yr ( infants ) and children > 1 yr ; infants bled more intraoperatively ( P<0.005 ) ; had greater cumulative CT output at 2 , 6 , 12 , and 24 h ( P<0.0001 ) ; and received more blood products ( P<0.0001 ) . Factors associated with bleeding and transfusions varied with patient age . Lower body core temperature during CPB was highly associated with blood loss and transfusions in infants , whereas resternotomy , preoperative congestive heart failure , and prolonged duration of CPB were significant factors associated with bleeding and transfusions in children > 1 yr old . IMPLICATION S Knowledge of the factors associated with blood loss and blood product transfusions can help to identify children at risk of excessive bleeding after open-heart surgery Background : Surgical correction of craniosynostosis in children is associated with substantial intraoperative bleeding . Tranexamic acid ( TXA ) decreases intraoperative blood loss during cardiac or orthopedic surgery in children . We hypothesized that intraoperative TXA would reduce blood transfusion relative to placebo in patients pretreated with erythropoietin . Methods : Forty consecutive children , American Society of Anesthesiologists status 1 or 2 , scheduled to undergo surgical correction of craniosynostosis were r and omly assigned to receive either intravenous TXA or saline , 0.9 % , intraoperatively . All children received preoperative erythropoietin ( 600 U/kg once a week for 3 weeks before surgery ) . Perioperative blood loss , number and volume of transfusions , percentage of children who underwent transfusion , and side effects were noted after surgery and at the end of the study . Surgeon satisfaction and cost of treatment were also recorded . Results : There was no significant difference between groups in demographic or surgical data . In the TXA group , the volume of packed erythrocytes transfused was significantly reduced by 85 % ( from 11 to 1.6 ml/kg ) intraoperatively and by 57 % ( from 16.6 to 7.2 ml/kg ) throughout the study period ( P < 0.05 ) . Compared with the placebo group , the percentage of children requiring blood transfusion was lower in the TXA group during surgery ( 9 [ 45 % ] of 20 vs. 2 [ 11 % ] of 19 children ; P < 0.05 ) and during the whole study period ( 14 [ 70 % ] of 20 vs. 7 [ 37 % ] of 19 ; P < 0.05 ) . Preoperative and postoperative hematologic parameters were comparable in both groups . There were no adverse events . Conclusion : In children undergoing surgical correction of craniosynostosis and pretreated with erythropoietin , intraoperative TXA reduces the transfusion requirement Study Design . A retrospective study of the effectiveness of Amicar ( epsilon aminocaproic acid ) . Objective . Evaluate the effectiveness of Amicar in decreasing perioperative blood loss and transfusion requirements in same-day anterior ( ASF ) and posterior spinal fusion ( PSF ) with segmental spinal instrumentation ( SSI ) for idiopathic scoliosis . Summary of Background Data . Preliminary prospect i ve , prospect i ve r and omized double-blind , and fibrinogen studies have demonstrated Amicar to be effective in decreasing perioperative blood loss in patients with idiopathic scoliosis undergoing PSF with SSI . Increased fibrinogen secretion is a possible explanation . Methods . There were 73 consecutive patients divided into 3 study groups based on the administration of Amicar : Group 1 ( n = 16 ) , no Amicar ; Group 2 ( n = 18 ) , Amicar for the PSF with SSI only ; and Group 3 ( n = 39 ) , Amicar for both ASF and PSF with SSI . All patients were managed using the same general anesthesia technique , intraoperative procedure , postoperative care path , and indications for transfusion ( hemoglobin < 7g/dL ) . Total perioperative blood loss ( estimated intraoperative blood loss for both procedures and measured postoperative chest tube and PSF wound suction drainage ) and total transfusion requirements between groups were compared using one-way ANOVA . Results . There were statistically significant decreases in mean estimated intraoperative PSF with SSI , total perioperative blood loss , and transfusion requirements in the 2 Amicar groups . However , Amicar had no significant effect on estimated intraoperative ASF blood loss , chest tube drainage , or PSF wound suction drainage . Total perioperative blood loss and transfusion requirements ( cell saver , autologous , directed , and allogeneic blood ) were : 3442.8 ± 1344.0 mL and 1537.1 ± 905.1 mL in Group 1 ; 2089.8 ± 684.0 mL and 485.2 ± 349.8 mL in Group 2 ; and 2184.1 ± 1163.7 mL and 531.5 ± 510.5 mL in Group 3 . There were no Amicar related complications . Conclusion . Amicar was highly effective in decreasing total perioperative blood loss and transfusion requirements in same-day ASF and PSF with SSI for idiopathic scoliosis . It results in less preoperative autologous blood donation , perioperative blood transfusion , costs , and potential transfusion-related complications . It was mosteffective in decreasing intraoperative estimated PSF with SSI blood loss . It had no significant effect during the ASF , postoperative chest tube , or PSF wound suction drainage . We now recommend that it be used for the PSF with SSI procedure only We performed a prospect i ve , r and omized , placebo-controlled , double-blind trial to assess the efficacy of aprotinin in 61 children ( median age 3.7 yr ) undergoing reoperative open heart surgery ( OHS ) . Three demographically similar groups were studied : large-dose aprotinin ( ALD ) , small-dose aprotinin ( ASD ) , and placebo ( P ) . Over the first 24 postoperative hours fewer patients in the aprotinin groups received packed red cells ( ALD , 53 % ; ASD , 89 % ; and P , 95 % ; P = 0.001 ) , platelets ( ALD , 32 % ; ASD , 50 % ; and P , 65 % ; P = 0.04 ) , and fresh frozen plasma ( ALD , 16 % ; ASD , 17 % ; and P , 60 % ; P = 0.003 ) than placebo patients . Most importantly , aprotinin patients had fewer exposures to banked blood components ( ALD , median 1 U ; and ASD , median 2 U ) than P ( median 6 U ; P \n Output:\n " }, { "from": "agent", "value": "Antifibrinolytics are effective in reducing blood loss and transfusion requirements in major pediatric surgery .\nTXA and EACA also appear to have reasonable side-effect profiles ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Abstract Hypoxia is an important modulator of endurance exercise‐induced oxidative adaptations in skeletal muscle . However , whether hypoxia affects resistance exercise‐induced muscle adaptations remains unknown . Here , we determined the effect of resistance exercise training under systemic hypoxia on muscular adaptations known to occur following both resistance and endurance exercise training , including muscle cross‐sectional area ( CSA ) , one‐repetition maximum ( 1RM ) , muscular endurance , and makers of mitochondrial biogenesis and angiogenesis , such as peroxisome proliferator‐activated receptor‐γ coactivator‐1α ( PGC‐1α ) , citrate synthase ( CS ) activity , nitric oxide synthase ( NOS ) , vascular endothelial growth factor ( VEGF ) , hypoxia‐inducible factor‐1 ( HIF‐1 ) , and capillary‐to‐fiber ratio . Sixteen healthy male subjects were r and omly assigned to either a normoxic resistance training group ( NRT , n = 7 ) or a hypoxic ( 14.4 % oxygen ) resistance training group ( HRT , n = 9 ) and performed 8 weeks of resistance training . Blood and muscle biopsy sample s were obtained before and after training . After training muscle CSA of the femoral region , 1RM for bench‐press and leg‐press , muscular endurance , and skeletal muscle VEGF protein levels significantly increased in both groups . The increase in muscular endurance was significantly higher in the HRT group . Plasma VEGF concentration and skeletal muscle capillary‐to‐fiber ratio were significantly higher in the HRT group than the NRT group following training . Our results suggest that , in addition to increases in muscle size and strength , HRT may also lead to increased muscular endurance and the promotion of angiogenesis in skeletal muscle We hypothesized that specific muscular transcript level adaptations participate in the improvement of endurance performances following intermittent hypoxia training in endurance-trained subjects . Fifteen male high-level , long-distance runners integrated a modified living low-training high program comprising two weekly controlled training sessions performed at the second ventilatory threshold for 6 wk into their normal training schedule . The athletes were r and omly assigned to either a normoxic ( Nor ) ( inspired O2 fraction = 20.9 % , n = 6 ) or a hypoxic group exercising under normobaric hypoxia ( Hyp ) ( inspired O2 fraction = 14.5 % , n = 9 ) . Oxygen uptake and speed at second ventilatory threshold , maximal oxygen uptake ( VO2 max ) , and time to exhaustion ( Tlim ) at constant load at VO2 max velocity in normoxia and muscular levels of selected mRNAs in biopsies were determined before and after training . VO2 max ( + 5 % ) and Tlim ( + 35 % ) increased specifically in the Hyp group . At the molecular level , mRNA concentrations of the hypoxia-inducible factor 1alpha ( + 104 % ) , glucose transporter-4 ( + 32 % ) , phosphofructokinase ( + 32 % ) , peroxisome proliferator-activated receptor gamma coactivator 1alpha ( + 60 % ) , citrate synthase ( + 28 % ) , cytochrome oxidase 1 ( + 74 % ) and 4 ( + 36 % ) , carbonic anhydrase-3 ( + 74 % ) , and manganese superoxide dismutase ( + 44 % ) were significantly augmented in muscle after exercise training in Hyp only . Significant correlations were noted between muscular mRNA levels of monocarboxylate transporter-1 , carbonic anhydrase-3 , glucose transporter-4 , and Tlim only in the group of athletes who trained in hypoxia ( P < 0.05 ) . Accordingly , the addition of short hypoxic stress to the regular endurance training protocol induces transcriptional adaptations in skeletal muscle of athletic subjects . Expressional adaptations involving redox regulation and glucose uptake are being recognized as a potential molecular pathway , result ing in improved endurance performance in hypoxia-trained subjects Twenty healthy high-altitude natives , residents of La Paz , Bolivia ( 3,600 m ) , participated in 6 wk of endurance exercise training on bicycle ergometers , 5 times/wk , 30 min/session , as previously described in normoxia-trained sea-level natives ( H. Hoppeler , H. Howald , K. E. Conley , S. L. Lindstedt , H. Claassen , P. Vock , and E. R. Weibel . J. Appl . Physiol . 59 : 320 - 327 , 1985 ) . A first group of 10 subjects was trained in chronic hypoxia ( HT ; barometric pressure = 500 mmHg ; inspired O2 fraction = 0.209 ) ; a second group of 10 subjects was trained in acute normoxia ( NT ; barometric pressure = 500 mmHg ; inspired O2 fraction = 0.314 ) . The workloads were adjusted to approximately 70 % of peak O2 consumption ( VO2peak ) measured either in hypoxia for the HT group or in normoxia for the NT group . VO2peak determination and biopsies of the vastus lateralis muscle were taken before and after the training program . VO2peak in the HT group was increased ( 14 % ) in a way similar to that in NT sea-level natives with the same protocol . Moreover , VO2peak in the NT group was not further increased by additional O2 delivery during the training session . HT or NT induced similar increases in muscle capillary-to-fiber ratio ( 26 % ) and capillary density ( 19 % ) as well as in the volume density of total mitochondria and citrate synthase activity ( 45 % ) . It is concluded that high-altitude natives have a reduced capillarity and muscle tissue oxidative capacity ; however , their training response is similar to that of sea-level residents , independent of whether training is carried out in hypobaric hypoxia or hypobaric normoxia BACKGROUND Exercise training improves physical fitness , insulin resistance , and endothelial function in type 2 diabetes . Hypoxia may further optimize these beneficial effects . The aim of this study was to compare the effects of hypoxic versus normoxic exercise training on physical fitness , endothelial function , and insulin resistance in type 2 diabetes . METHODS Peak oxygen consumption , flow mediated dilation ( endothelial function ) , and glucose homeostasis were assessed in 19 patients ( 55±7 years ) before and after an 8-week intervention . Subjects were r and omly allocated to normoxic ( 21 % O2 , n=9 ) or hypoxic ( 16.5 % O2 , n=10 ) exercise training . Endothelium-independent dilation was examined using sublingual administration of glyceryl trinitrate , and used to calculate the ratio between endothelium-dependent and -independent dilation . RESULTS Exercise training improved physical fitness and brachial artery ratio between endothelium-dependent and -independent dilation ( both p<0.05 ) , whilst these exercise training-induced changes were similar in both groups ( interaction-effects p>0.05 ) . Exercise training did not significantly change brachial artery flow-mediated dilation or glyceryl trinitrate-response , superficial femoral artery flow-mediated dilation , or glucose homeostasis , whilst hypoxia did not alter the impact of exercise training . CONCLUSION Contrary to our hypothesis , hypoxia does not potentiate the effect of exercise training on physical fitness , vascular function , or glucose homeostasis in type 2 diabetes This study was performed to explore changes in gene expression as a consequence of exercise training at two levels of intensity under normoxic and normobaric hypoxic conditions ( corresponding to an altitude of 3,850 m ) . Four groups of human subjects trained five times a week for a total of 6 wk on a bicycle ergometer . Muscle biopsies were taken , and performance tests were carried out before and after the training period . Similar increases in maximal O(2 ) uptake ( 8.3 - 13.1 % ) and maximal power output ( 11.4 - 20.8 % ) were found in all groups . RT-PCR revealed elevated mRNA concentrations of the alpha-subunit of hypoxia-inducible factor 1 ( HIF-1 ) after both high- ( + 82.4 % ) and low (+78.4%)-intensity training under hypoxic conditions . The mRNA of HIF-1alpha(736 ) , a splice variant of HIF-1alpha newly detected in human skeletal muscle , was shown to be changed in a similar pattern as HIF-1alpha . Increased mRNA contents of myoglobin ( + 72.2 % ) and vascular endothelial growth factor ( + 52.4 % ) were evoked only after high-intensity training in hypoxia . Augmented mRNA levels of oxidative enzymes , phosphofructokinase , and heat shock protein 70 were found after high-intensity training under both hypoxic and normoxic conditions . Our findings suggest that HIF-1 is specifically involved in the regulation of muscle adaptations after hypoxia training . Fine-tuning of the training response is recognized at the molecular level , and with less sensitivity also at the structural level , but not at global functional responses like maximal O(2 ) uptake or maximal power output Background and Objectives Increased central arterial stiffness is an emerging risk factor for cardiovascular disease . Acute aerobic exercise reduces arterial stiffness , while acute resistance exercise may increase arterial stiffness , but this is not a universal finding . We tested whether an acute resistance exercise program was associated with an increase in arterial stiffness in healthy young men . Subjects and Methods Thirteen healthy subjects were studied under parallel experimental conditions on 2 separate days . The order of experiments was r and omized between resistance exercise ( 8 resistance exercises at 60 % of 1 repeated maximal ) and sham control ( seated rest in the exercise room ) . Carotid-femoral pulse wave velocity ( PWV ) and aortic augmentation index as indices of aortic stiffness were measured using applanation tonometry . Measurements were made at baseline before treatments , 20 minutes , and 40 minutes after treatments ( resistance exercise and sham control ) . Results There was no difference in resting heart rate or in arterial stiffness between the two experimental conditions at baseline . At 20 minutes after resistance exercise , heart rate , carotid-femoral PWV and augmentation index@75(% ) were significantly increased in the resistance exercise group compared with the sham control ( p<0.05 ) . Brachial blood pressure , central blood pressure and pulse pressure were not significantly increased after resistance exercise . Conclusion An acute resistance exercise program can increase arterial stiffness in young healthy men . Further studies are needed to clarify the effects of long-term resistance training on arterial stiffness Background Intermittent normobaric hypoxia training , an alternative to altitude training for athletes , may be beneficial to treat overweight and obesity . The purpose of this study is to investigate whether normobaric hypoxia training combined with low-caloric diet has the additive effect on weight loss compared with normoxia training in obese young adults . Methods Twenty-two subjects ( age 17–2 \n Output:\n " }, { "from": "agent", "value": "Conclusion Based on current published studies , hypoxic ExT potentiates vascular adaptations related to skeletal muscle capillarization and dilator function .\nThese findings may contribute to establishing effective exercise programs design ed to enhance vascular health" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A prospect i ve , r and omized , double-blind trial was carried out to compare cruciate-retaining ( CR ) and posterior-stabilized ( PS ) total knee arthroplasties ( TKAs ) . A total of 40 knees were r and omized to receive either a NexGen CR ( Zimmer , Warsaw , IN ) or a Legacy PS ( Zimmer , Warsaw , IN ) TKA . All knees were implanted with identical surgical technique , making sure to balance precisely the flexion-extension gaps before implantation of the components . At 2-year follow-up , there was no difference between the CR and the PS TKAs with respect to their Knee Society clinical , functional , and radiographic scores . These findings suggest that with careful attention to surgical technique and balancing the knee , orthopaedic surgeons should expect similar results whether they use a CR or PS TKA We report the results of a prospect i ve r and omised trial which assessed the role of the posterior cruciate ligament ( PCL ) following total knee replacement ( Genesis I ; Smith and Nephew , Memphis , Tennessee ) . Over a four-year period , 211 patients underwent total knee replacement by the senior author ( TJW ) . They were r and omised at surgery to have the PCL either retained , excised or substituted with a posterior stabilised insert . If it was not possible to retain the ligament due to soft-tissue imbalance , it was released from its tibial insertion until suitable tension was obtained . This created a fourth group , those who were intended preoperatively to have the ligament retained , but in whom it was partially released as a result of findings at the time of surgery . All patients were evaluated using the Knee Society rating system ( adapted from Insall ) . A total of 188 patients ( 212 knees ) was available for follow-up at a mean of 3.5 years after surgery . Preoperatively , there was a varus deformity in 191 knees ( 90 % ) and a valgus deformity in 21 ( 10 % ) . There were no statistical differences in the knee or function scores or the range of movement between the excised , retained and substituted groups . There were , however , significantly worse knee and function scores in the group in whom the PCL was released ( p = 0.002 ) Abstract Purpose Posterior-cruciate-ligament-retaining ( PCR ) and posterior-cruciate-ligament-stabilized ( PS ) arthroplasties are two major common practice s in total knee arthroplasty ( TKA ) . The hypothesis of the present study was that compared with the PCR technique , the PS technique is associated with a higher amount of postoperative blood loss and greater need for blood transfusion in cemented TKA . Methods In this prospect i ve , r and omized study , 100 patients diagnosed with primary knee osteoarthritis were r and omly assigned to either the PCR group ( Group I ) or the PS group ( Group II ) . The exclusion criteria were rheumatological joint disease , previous knee surgery , anticoagulant therapy and hypertension . There were no significant differences in age , body mass index and gender , between the groups . The haemoglobin and haematocrit levels of each patient were recorded preoperatively and on postoperative days 1 , 3 and 5 . The postoperative suction drainage and blood transfusion volumes were also recorded . Results There were no statistically significant differences in haemoglobin or haematocrit levels between the groups on postoperative days 1 , 3 and 5 . There were also no statistically significant differences in the total measured blood loss volume , postoperative drainage amounts or transfusion rates between the groups . Conclusion Use of the PS technique during cemented TKA does not appear to influence the amount of perioperative blood loss or the need for postoperative blood transfusion in general . The clinical relevance of this study is that the difference in blood loss between the PCR and PS techniques does not need to be considered by surgeons when performing TKA.Level of evidence The superiority between the posterior cruciate-retaining and the posterior cruciate-substituting design s still remains controversial . We performed a prospect i ve , r and omized control study for evaluation of the superiority of these design s. This study investigated 58 knees in 29 patients with simultaneous bilateral total knee arthroplasty , in which the high-flex CR design was r and omly implanted in one knee and the high-flex PS design was implanted in the other knee . The follow-up duration averaged 5.0 years , with a minimum duration of 3 years . Postoperatively , Knee Score and pain points in Knee Score result ed in no significant differences between the 2 design s. However , postoperative arc of range of motion , patient satisfaction , and posterior knee pain at passive flexion in the PS design were significantly superior to that of the CR design A prospect i ve , r and omized comparison of posterior cruciate-retaining ( PCR ) and posterior stabilized ( PS ) total knee arthroplasties ( TKAs ) was conducted in 20 patients who underwent bilateral TKAs for osteoarthritis . All procedures were performed by a single surgeon . One knee was implanted with a PCR TKA , and a contralateral knee with a PS TKA . Both prosthetic design s were of the same TKA series , with comparable surface geometries . Patients had a clinical and radiographic evaluation at a mean of 31.7 months for PCR TKAs and 30.6 months for PS TKAs postoperatively . There were no significant differences between the PCR and PS TKAs in postoperative knee scores . However , postoperative improvement in range of motion was significantly superior in the PS group Introduction This study focused on the change in the range of motion ( ROM ) during the perioperative period , i.e. , the preoperative and intraoperative ROM , and that on discharge , and compared the difference between posterior cruciate ligament-retaining ( PCLR ) and -sacrificing ( PCLS ) prostheses . Material s and methods In this prospect ively r and omized study , we compared the changes in the ROM in PCLR ( n = 50 ) and PCLS ( n = 50 ) total knee arthroplasties . Results The mean flexion in PCLR prostheses was 130.0 ° preoperatively , 120.0 ° intraoperatively , and 105.0 ° at discharge , and 125.0 ° , 120.0 ° , and 100.0 ° , respectively , in PCLS . The design s did not differ statistically in each period ( P > 0.05 ) . Both design s showed significant correlations between the preoperative and intraoperative ROM , and between the preoperative and discharge ROM . Only the PCLS showed a significant correlation between the intraoperative and discharge ROM , and a significant difference was observed in correlation of rank coefficient between the two prostheses ( P < 0.001 ) . Conclusions The PCLS design has an advantage in rehabilitation planning because of the predictable changes in the ROM during the perioperative period , although the acquired average ROM at discharge did not differ statistically Purpose Although the patella reduced or everted position has recently been recognised as an important factor influencing soft tissue balance during assessment in total knee arthroplasty ( TKA ) , the influence of patella height on soft tissue balance has not been well addressed . Therefore , the relationship between soft tissue balance and patella height was investigated and differences between cruciate-retaining ( CR ) and posterior-stabilised ( PS ) TKA were compared . Methods Forty consecutive patients blinded to the type of implant received , were r and omised prospect ively . Using lateral radiographs , pre-operative patella height was measured . Using an offset-type tensor design ed to measure the soft tissue balance with a reduced patellofemoral ( PF ) joint and femoral component in place , soft tissue balance was intra-operatively assessed in CR TKA ( n = 20 ) and PS TKA ( n = 20 ) in osteoarthritic patients . The joint component gap and varus ligament balance at zero , ten , 45 , 90 and 135 ° of knee flexion with the patella reduced were measured . Results In PS TKA , the joint component gap positively correlated with patella height at 90 and 135 ° of knee flexion . However , there was no correlation between joint component gap and patella height at other flexion angles in PS TKA and any flexion angle in CR TKA . Varus ligament balance showed no significant correlation with patella height in either CR or PS TKA . Conclusion Analysis of soft tissue balance and patella height only showed a positive correlation in joint component gap at a high flexion angle ( 90 and 135 ° ) in PS TKA but not in other parameters examined . Pre-operative measurement of patella height may be an important factor for predicting an intra-operative flexion gap in PS TKA We performed a prospect i ve , r and omised trial of 44 patients to compare the functional outcomes of a posterior-cruciate-ligament-retaining and posterior-cruciate-ligament-substituting total knee arthroplasty , and to gain a better underst and ing of the in vivo kinematic behaviour of both devices . At follow-up at five years , no statistically significant differences were found in the clinical outcome measurements for either design . The prevalence of radiolucent lines and the survivorship were the same . In a subgroup of 15 knees , additional image-intensifier analysis in the horizontal and sagittal planes was performed during step-up and lunge activity . Our analysis revealed striking differences . Lunge activity showed a mean posterior displacement of both medial and lateral tibiofemoral contact areas ( roll-back ) which was greater and more consistent in the cruciate-substituting than in the cruciate-retaining group ( medial p < 0.0001 , lateral p = 0.011 ) . The amount of posterior displacement could predict the maximum flexion which could be achieved ( p = 0.018 ) . Forward displacement of the tibiofemoral contact area in flexion during stair activity was seen more in the cruciate-retaining than in the cruciate-substituting group . This was attributed mainly to insufficiency of the posterior cruciate ligament and partially to that of the anterior cruciate ligament . We concluded that , despite similar clinical outcomes , there are significant kinematic differences between cruciate-retaining and cruciate-substituting arthroplasties BACKGROUND The effect of total knee arthroplasty on proprioception , kinesthesia , and postural control remains controversial . It is argued that retaining the posterior cruciate ligament may help to preserve these sensorimotor functions and improve the longevity of the prosthesis and the functional outcome . We performed a prospect i ve , r and omized study to assess proprioception , kinesthesia , and balance following total knee arthroplasty with cruciate-retaining and posterior stabilized prostheses . METHODS Twenty patients scheduled to undergo total knee arthroplasty were r and omly assigned to receive either a cruciate-retaining or a posterior stabilized prosthesis . Joint-position sense , the threshold to detect joint motion , and the subject 's ability to balance on an unstable platform were assessed prior to and at least six months after the operation . Paired two-tailed t tests ( with a level of significance of p < 0.05 ) were used to assess the effect of the arthroplasty on the preoperative measures for all subjects . Analysis of covariance was performed to identify the effects of prosthetic design . RESULTS Following total knee arthroplasty , patients detected motion significantly faster and reproduced joint position with less error . The balance index also improved significantly from the preoperative to the postoperative evaluation . The group treated with the posterior stabilized prosthesis more accurately reproduced joint position when the knee was extended from a flexed position . CONCLUSIONS Total knee arthroplasty results in mild improvements in proprioception , kinesthesia , and balance . These changes may result from the retensioned capsuloligamentous structures and reduced pain and inflammation . Retention of the posterior cruciate ligament does not appear to significantly improve proprioception and balance compared with those functions in patients with a posterior stabilized total knee design Background Little information exists to support that patients care about flexion beyond what is needed to perform activities of daily living ( ADL ) after Total knee arthroplasty ( TKA ) . The purpose of this study was to investigate if the achievement of a higher degree of knee flexion after TKA would result in a better patient perceived outcome . Methods The study is a r and omized , double-blinded , controlled trial in which 36 patients ( mean age : 67.2 yrs ) undergoing one-stage bilateral TKA r and omly received a st and ard cruciate-retaining ( CR ) TKA in one knee and a high-flex posterior-stabilized ( PS ) TKA in the contra lateral knee . At follow-up ROM , satisfaction , pain , “ feel ” of the knee and the abilities in daily activities were assessed . Results At 1-year follow-up we found an expected significantly higher degree of knee flexion of 7 ° in the high-flex knees ( p = 0.001 ) . The high-flex TKA ’s showed a mean active flexion of 121 ° . In both TKA ’s the median VAS pain score was 0 , the median VAS satisfaction score was 9 , and the median VAS score of the patient “ feel ” of the knee was 9 at 1-year follow-up . Further , there were no significant differences between the knees in the performance of daily activities . Conclusions As expected the high-flex TKA showed increased knee flexion , but no significant differences in the patient perceived outcomes were found . This suggests little relevance to the patients of the difference in knee flexion – when flexion is of this magnitude – as pain free ROM and high patient satisfaction were achieved with both TKA’s . Trial registration Clinical Trials.gov : Purpose The purpose of this study is to investigate whether the preservation of the posterior cruciate ligament ( PCL ) \n Output:\n " }, { "from": "agent", "value": "Interpretation We found no clinical ly relevant differences between retention and sacrifice of the PCL in TKA , in terms of functional and clinical outcomes .\nBased on the current evidence , no recommendation can be made as to whether to retain or to sacrifice the PCL" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine contraceptive efficacy of hormonally induced sperm suppression to severe oligozoospermia or azoospermia . DESIGN Prospect i ve , noncomparative contraceptive efficacy study . SETTING Multicenter study in 15 centers in nine countries . PARTICIPANTS Three hundred ninety-nine normal , healthy , fertile men requesting a male contraceptive method . INTERVENTION Weekly IM injection of 200 mg T enanthate . MAIN OUTCOME MEASURE Incidence of pregnancies in efficacy when couples relied on T injections alone for contraception . RESULTS Four pregnancies occurred during 49.5 person-years involving men with oligozoospermia ( 0.1 to 3 x 10(6)/mL ) and none during 230.4 person-years in azoospermic men : pregnancy rates 8.1 ( 95 percent confidence interval [ CI ] 2.2 to 20.7 ) and 0.0 ( 95 percent CI , 0.0 to 1.6 ) per 100 person-years , respectively , or 1.4 ( 95 percent CI , 0.4 to 3.7 ) per 100 person-years for oligozoospermia and azoospermia ( O to 3 x 10(6)/mL ) combined . Pregnancy rates were related to sperm concentration . Inadequate suppression of spermatogenesis occurred in eight men and escape from suppression occurred in four . Discontinuations were due to personal reasons ( 50 men , cumulative annual life-table rate 12.2 percent [ 95 percent CI , 9.1 percent to 16.1 percent ] ) and dislike of the injection schedule ( 21 men , 5.1 percent [ 95 percent CI , 3.2 percent to 7.9 percent ] ) . Thirty-five men discontinued for medical reasons ( 9.4 percent [ 95 percent CI , 6.7 percent to 13.2 percent ] ) , with no serious treatment-related side effects . After stopping injections , sperm output recovered ; additionally , fertility was demonstrated in 33 couples . CONCLUSION Suppression of spermatogenesis to azoospermia or severe oligozoospermia ( < or = 3 x 10(6)/mL ) induced by weekly T enanthate injections results in sustained , reversible contraception with good efficacy and minimal short-term side effects . New hormonal regimens with more convenient delivery and improved spermatogenic suppression would provide practical male contraception Following the intravasal injection of a new male contraceptive RISUG ( reversible inhibition of sperm under guidance ) in volunteers , routine semen analysis , semen biochemistry and germ cell morphology were evaluated in comparison with the corresponding preinjection sample s for a maximum period of 6 months . Sperm counts in all 25 subjects before injection varied from 45 to 120 x 10(6)/ml . Out of 25 subjects , 6 became azoospermic after 1 month , 15 after 2 months , 3 after 3 months and 1 after 4 months of contraceptive injection . The mean volume of the ejaculates was found to be less as compared to preinjection sample s. Occasional sperm or sperm heads and immature germ cells were identified in only a few postinjected subjects . However , no pregnancy was reported in these subjects during the study period . Abnormal morphology found in most of the sperm , but not in the accompanying immature germ cells , may be due to a charge-related effect on the former but not on the latter cells . Neutral alpha-glucosidase , the biochemical marker for epididymis , was estimated to be significantly lower in the seminal plasma of all the postinjected subjects . On the other h and , acid phosphatase activity and fructose levels in the seminal plasma were found to be in the normal range . Based on the above findings , it is concluded that at least for the present study period , RISUG , a new male contraceptive , is effective as a partially occluding agent in the vas deferens Following up on an earlier clinical trial demonstrating the safety of an intra-vas deferens injection of a contraceptive drug named Risug , comprised of styrene maleic anhydride ( SMA ) in a solvent vehicle of dimethylsulphoxide ( DMSO ) , a study to assess the contraceptive effectiveness of a specific dose ( 60 mg ) of SMA bilaterally was planned and implemented . Male subjects and their wives with normal reproductive profiles were the volunteer subjects . The wives were not using any contraceptives . The results reconfirm the safety and show that for a period of at least 1 year , the treatment leads to azoospermia in the male and gives pregnancy protection The safety and efficacy of gossypol continues to be controversial . The aim of this study was to evaluate gossypol as a contraceptive pill for men at doses lower than those previously prescribed and in men from various ethnic origin . A total of 151 men from Brazil , Nigeria , Kenya , and China were divided into two groups . Both groups received 15 mg gossypol/day for 12 or 16 weeks to reach spermatogenesis suppression . Subjects were then r and omized to either 7.5 or 10 mg/day for 40 weeks . In addition , 51 men were enrolled as a control group . In all , 81 subjects attained spermatogenesis suppression . Only one man discontinued treatment because of tiredness . Potassium levels fluctuated within the normal range . FSH increased consistently . Testicular volume decreased , but after discontinuation , values returned to levels not statistically different from admission . Of 19 subjects on the 7.5 mg/day dose group , 12 recovered sperm counts > 20 million/mL within 12 months of discontinuing gossypol . In the 10 mg/day group , sperm counts recovered in only 10 of 24 subjects . Eight of the 43 patients remained azoospermic 1 year after stopping gossypol . All men diagnosed with varicocele failed to reverse spermatogenesis suppression . Gossypol blood levels indicated that sperm suppression occurs independently of concentration , whereas spermatogenesis recovery appears to be concentration-dependent . Gossypol may become a medical alternative to surgical vasectomy when the delay in onset of infertility is acceptable . When taken for 1 year , gossypol causes no reduction in sexual desire or frequency of intercourse . The possibility of reversal , occurring in 51 % of the men on this regimen within 1 year after stopping gossypol , is an advantage of this compound as compared with surgical sterilization in many parts of the world Earlier studies on the rat and the monkey had demonstrated that an injection of styrene maleic anhydride ( SMA ) in a solvent vehicle of dimethyl sulphoxide ( DMSO ) into the lumen of the vas deferens is toxicologically safe and has contraceptive action . Phase I clinical trial was therefore undertaken on 38 male volunteers giving varying doses of SMA , ranging between 5 mg and 140 mg , into each vas deferens . A dose of 70 mg is the predicted therapeutic dose based on animal data . That the compound is within the vas deferens lumen during the period of the safety assessment is inferred from the effect on the spermatozoa count in ejaculates which reach azoospermic levels in the higher dose ranges . The treatment is well tolerated with only minimal side effects in a few cases and no long-term adverse effects A r and omized controlled study was design ed to evaluate the merit of whether ingesting potassium salt or potassium ( K ) blocking agent while using gossypol contraceptive drug could alleviate the symptom of hypokalemia . Results indicate that K salt supplementation did not reverse the gossypol-related hypokalemia and that the blocking agent triamterene did not prevent loss of or enhance the retention of serum \n Output:\n " }, { "from": "agent", "value": "Gossypol had problems with low efficacy and toxicity .\nAlthough sperm density was lower among those taking Tripterygium , later reports indicated some toxicity .\nAt this time , no safe and effective nonhormonal drug is available for contraception in men ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We prospect ively examined the association between alexithymia and risk of death over an average follow-up time of nearly 5.5 years in 42- to 60-year-old men ( N = 2297 ) participating in the Kuopio Ischemic Heart Disease Risk Factor Study ( KIHD ) . Alexithymia , impairment in identification , processing , and verbal expression of inner feelings , was assessed by the vali date d Toronto Alexithymia Scale ( TAS ) In age-adjusted survival analyses , men in the highest alexithymia quintile had a twofold greater risk of all-cause death ( p < 0.001 ) and a threefold greater risk of death from accidents , injury , or violence ( p < 0.02 ) relative to the men in the three lowest alexithymia quintiles . There was little evidence for confounding by behavioral factors ( smoking , alcohol consumption , physical activity ) . physiological risk factors ( LDL , HDL , body mass index , hypertension ) , socioeconomic status , marital status , perceived health , prior diseases and diagnoses , depressive symptoms or social connections . Consistent and even stronger associations between alexithymia and all-cause death were found in a healthy subgroup ( N = 1650 ) . Why difficulties in dealing with emotions associate with increased mortality remains unclear . Our findings suggest that the association is independent from the effect of well-known behavioral , biological , and psychosocial risk factors This study explored the relative strength of two patient characteristics , psychological mindedness ( PM ) and alexithymia , as predictors of psychotherapy outcome . Data were provided by two comparative trials of interpretive versus supportive therapy . One involved short-term group therapy for 107 out patients with complicated grief . The other involved short-term individual therapy for 144 out patients of mixed diagnoses . Prior to beginning therapy , patients were assessed for PM using the Psychological Mindedness Assessment Procedure and for alexithymia using the 20-item Toronto Alexithymia Scale . For both trials , the association between PM and alexithymia was small and non-significant . The therapy approach ( interpretive vs. supportive ) did not differentially affect the relationship between either predictor variable and outcome . There were significant direct relationships between PM and favourable outcome , and between alexithymia and favourable outcome in both trials . There was an additive relationship between PM and alexithymia in predicting outcome . Implication s of these results are discussed In the present study , the potential role of alexithymia in predicting the long-term treatment outcome was investigated prospect ively in 30 patients with DSM-III-R somatoform disorders and anxiety disorders . Using SCID interviews , diagnoses were assessed before inpatient treatment and 2 years after discharge . Patients who met criteria for DSM-III-R undifferentiated somatoform disorder at follow-up exhibited higher pretreatment alexithymia scores ( as measured by the TAS ) as compared with patients who showed remission of their somatoform disorder or patients who never had met criteria for a somatoform disorder . As a result stepwise logistic regression analyses , high alexithymia scores emerged as a significant predictor of persistent somatization , independent of other measures of psychopathology , sociodemographic variables , and measures of illness severity The relationship of alexithymia to posttraumatic stress disorder ( PTSD ) symptomatology was examined cross-sectionally in 166 urban police officers surveyed between 1998 and 1999 and prospect ively in 54 of these officers who participated in a follow-up survey after the September 11 , 2001 ( 9/11 ) terrorist attacks . In cross-sectional analyses , alexithymia scores were positively associated with PTSD symptom levels and self-reported childhood emotional abuse -- neglect , but not with cumulative level of critical incident exposure . Alexithymia scores accounted for 11.2 % of the variance in PTSD symptoms prior to accounting for additional predictors , but did not retain significance in the final model . In prospect i ve analyses , alexithymia scores significantly predicted 9/11-related PTSD symptom severity over and above pre-9/11 PTSD symptoms The goal was to examine prospect ively the relation of psychological factors to the outcome after in vitro fertilization ( IVF ) in a sample of Greek women . Previous studies investigating the relation of IVF outcome to anxiety and depression have yielded contradictory results ; other psychological dimensions have not been studied . 81 women who followed an IVF program during a 6-mo . period were prospect ively evaluated . Demographic and gynecological data were assessed and women completed question naires measuring anxiety , depression , narcissistic traits , over-dependency , self-esteem , hostility , and alexithymia . Multiple logistic regression analysis showed that successful IVF outcome correlated with more alexithymic characteristics and younger age . Correlation between alexithymia and successful IVF outcome is demonstrated . This might be explained by the “ operational ” nature of IVF techniques , to which alexithymic individuals would respond better OBJECTIVE Most studies focusing on risk factors for posttraumatic stress disorder ( PTSD ) have used retrospective study design s. Only a small number of studies have prospect ively examined risk factors in the immediate aftermath of trauma exposure in predicting PTSD symptoms . The purpose of this study was to identify predictive risk factors for posttraumatic stress symptoms and comorbid psychopathological symptoms present during the time before exposure to traumatic stress in a high-risk population . METHOD Forty-three professional firefighters were assessed immediately after basic training ( baseline ) and at 6 , 9 , 12 , and 24 months after entry into firefighter service . Subjects were screened for psychopathological symptoms , including symptoms of PTSD , depression , and anxiety . Subjects were also characterized with regard to personality traits such as self-efficacy , hostility , and alexithymia . Neuroendocrine activity was assessed by examination of awakening and diurnal salivary cortisol profiles and 24-hour urinary catecholamine excretion . Multiple linear regression analysis was used to analyze posttraumatic stress symptoms at 24-month follow-up as a function of pretraumatic characteristics . RESULTS A high level of hostility and a low level of self-efficacy at baseline accounted for 42 % of the variance in posttraumatic stress symptoms after 2 years . Subjects who had both risk factors at baseline showed a significant increase in measures of PTSD symptoms , depression , anxiety , general psychological morbidity , global symptom severity , and alexithymia during the 2-year period . Biological characteristics were not predictive of the development of psychopathological symptoms . CONCLUSIONS These results suggest that specific personality traits may constitute markers of vulnerability to the development of psychopathological symptoms after trauma exposure . Early identification of preexisting risk factors is needed to provide effective prevention and intervention for individuals who are at risk of developing trauma-related disorders Patient treatment matching hypotheses were tested for substance users r and omly assigned to a group cognitive behavioral therapy ( CBT ; n= 114 ) or a group motivational intervention ( GMI ; n= 116 ) . Treatment was scheduled twice weekly for 10 weeks . Using a patient attribute by treatment interaction design with a 15-week follow-up , the study predicted that alexithymia , antisocial personality disorder ( ASPD ) , and network support for alcohol and drug use would be associated with less substance use for CBT subjects and that hostility and lower treatment motivation would be associated with less substance use for GMI subjects . Three of the hypothesized moderators were empirically supported : alexithymia , network support for alcohol , and ASPD . Results indicate the use of assessing specific patient attributes to better inform treatment recommendations Purpose . To date , there are no studies that have investigated the role of alexithymia in respiratory rehabilitation . We aim ed to observe the prevalence of alexithymia in patients attending respiratory rehabilitation and to verify the presence of a difference between alexithymics and non-alexithymics responsiveness to the respiratory rehabilitation st and ard protocol . Methods . A prospect i ve cohort study evaluating the influence of alexithymia on functional recovery of in- patients afferent to the Respiratory Rehabilitation Unit of IRCCS San Raffaele Pisana . Sixty patients were consecutively enrolled into the study and evaluated for alexithymia , anxiety and depression . Functional recovery was assessed with the six-minute walking test ( 6MWT ) . Prior and post-completion of this test dyspnoea , oxygen saturation and cardiac frequency were recorded . Results . Alexithymia was not found to be significantly affecting the functional recovery of participants in respiratory rehabilitation . The distance walked at the 6MWT ( 6MWD ) increased in both alexithymics and non-alexithymics ( palexithymics = 0.014 ; pnon-alexithymics < 0.0001 ) . Dyspnoea strongly improved among non-alexithymics , although a signal for improvement was also found in alexithymics ( palexithymics = 0.046 ; pnon-alexithymics = 0.0001 ) . Conclusions . These findings suggest that alexithymia did not have a significant impact on functional recovery of patients in respiratory rehabilitation Background : Alexithymia refers to a set of cognitive and emotional deficits . Its effect on surgical outcome has been demonstrated but no studies have been published on colorectal cancer patients . Study Design : A series of 60 consecutive colorectal cancer patients were enrolled in a 3-year prospect i ve study on quality of life by using the SF-36 test and Toronto Alexithymia Scale question naires . Patients were investigated pre- and postoperatively ( before discharge and then 1 and 3 months thereafter ) . The control group consisted of patients undergoing laparoscopic cholecystectomy for cholelithiasis . These two groups were divided into two subsets : high-level alexithymia ( HA ) and low-level alexithymia ( LA ) . The prevalence of HA was 34 % in colorectal patients and 35 % in cholelithiasis patients . Results : During the postoperative period , in the colorectal group the SF-36 score was significantly higher in HA than in LA subsets . This result was confirmed in the cholelithiasis group . During follow-up , a progressive reduction of the SF-36 score was observed in both HA population s. Discussion : Results emerging from this investigation demonstrate that surgery significantly improves the quality of life in HA patients . These findings suggest that alexithymia might be advantageous in evaluating the adaptation after surgery in the short follow-up period OBJECTIVE Longitudinal studies have shown that alexithymic features can interfere with treatment response in eating disorders . However , an alternative hypothesis could be that clinicians faced with alexithymic patients chose different treatment options according to their perceptions of these patients . The aim of this investigation was to explore the relationships between alexithymic features and treatment options provided by professionals in a naturalistic prospect i ve study of eating disorders . METHODS We conducted a 3-year longitudinal study exploring a sample of 102 DSM-IV Eating Disorder patients with the Toronto Alexithymia Scale ( TAS-20 ) . All treatments received during follow-up were recorded and recoded dichotomously , and crossed with the variation of alexithymic categories ( cut-off≥56 ) between inclusion and follow-up . RESULTS Patients received different treatments according to their alexithymic profile , in terms both of number and type of treatment received . Patients with high , stable levels of alexithymia received overall more treatments , and significantly more antidepressants , than non-alexithymic patients . Patients who became alexithymics during follow-up were more often rehospitalized and received fewer regular psychotherapies than the non-alexithymic patients . CONCLUSIONS Professionals should carefully monitor these personality features and be aware of the potential impact of alexithymic features on treatment compliance and on treatment choice for eating disordered patients Background : Alexithymia as a predictor of treatment outcome in psychotherapy has often been discussed but rarely evaluated in prospect i ve studies . The present study evaluated the absolute and relative stability of alexithymia in patients with obsessive-compulsive disorder ( OCD ) , and the predictive value of alexithymia for the outcome of treatment . Methods : We conducted a prospect i ve study with 42 in patients receiving intensive , multimodal cognitive-behavioral therapy ( CBT ) . Patients were assessed for alexithymia at pre- and post-treatment with the 20-item Toronto Alexithymia Scale ( TAS-20 ) , for obsessive-compulsive symptoms and depression with the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) and the 21-item Hamilton Depression Rating Scale ( HDRS ) . Results : OCD and comorbid depression showed a highly significant symptom-reduction from pre- to post-treatment while no absolute changes in the TAS-20 total scores and its factors 1 and 3 occurred . Only factor 2 scores decreased significantly , but with a smaller effect size than the effect sizes for the changes in Y-BOCS and HDRS . Alexithymia scores at pre-treatment correlated significantly with alexithymia scores at the end of treatment , indicating its relative stability . In the linear regression analyses , no variables were identified that predicted significantly the outcome of treatment . Conclusions : Our findings support the view that alexithymia is a stable personality trait rather than a state-dependent phenomenon in obsessive-compulsive patients . Alexithymia scores do not predict response to multimodal CBT in OCD . It might be an effect of CBT that patients could at least partly regain or newly \n Output:\n " }, { "from": "agent", "value": "In conclusion , epidemiological evidence regarding alexithymia as a prognostic risk factor for health problems remains un-established .\nEven though alexithymia is considered to be an unfavorable characteristic for disease control and health promotion overall , some beneficial aspects are suggested ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Clinical Queries filters were developed to improve the retrieval of high- quality studies in search es on clinical matters . The study objective was to determine the yield of relevant citations and physician satisfaction while search ing for diagnostic and treatment studies using the Clinical Queries page of PubMed compared with search ing PubMed without these filters . MATERIAL S AND METHODS Forty practicing physicians , presented with st and ardized treatment and diagnosis questions and one question of their choosing , entered search terms which were processed in a r and om , blinded fashion through PubMed alone and PubMed Clinical Queries . Participants rated search retrievals for applicability to the question at h and and satisfaction . RESULTS For treatment , the primary outcome of retrieval of relevant articles was not significantly different between the groups , but a higher proportion of articles from the Clinical Queries search es met method ologic criteria ( p=0.049 ) , and more articles were published in core internal medicine journals ( p=0.056 ) . For diagnosis , the filtered results returned more relevant articles ( p=0.031 ) and fewer irrelevant articles ( overall retrieval less , p=0.023 ) ; participants needed to screen fewer articles before arriving at the first relevant citation ( p<0.05 ) . Relevance was also influenced by content terms used by participants in search ing . Participants varied greatly in their search performance . DISCUSSION Clinical Queries filtered search es returned more high- quality studies , though the retrieval of relevant articles was only statistically different between the groups for diagnosis questions . CONCLUSION Retrieving clinical ly important research studies from Medline is a challenging task for physicians . Method ological search filters can improve search retrieval Physicians often fail to provide nationally recommended preventive services for their patients . Addressing this , we have review ed selected literature on changing physician behavior using the organizational construct of the \" readiness for change \" transtheoretical model . This model suggests that behavior evolves through stages from precontemplation , to contemplation , to preparation , to initiation , and to maintenance of change . Traditional continuing medical education may affect knowledge and beliefs , but rarely results in behavior change . However , motivational strategies such as practice feedback reports and influential peers can foster stage change . Successful interventions aim ed at physicians preparing for change frequently use an office-system approach that targets not only physicians , but office staff and patients as well . Illustrating how the readiness to change model can guide the design and implementation of interventions , we describe strategies being used in a statewide r and omized controlled trial to improve cancer prevention counseling and early detection by primary care physicians . The multistage interventions of Partners for Prevention include support from a medical liability carrier , a motivational videotape , a task-delineated office manual , chart flowsheets , patient activation forms , practice feedback reports , a design ated prevention coordinator within each practice and regular telephone calls and office visits by project staff Background Although for more than a decade healthcare systems have attempted to provide evidence -based mental health treatments , the availability and use of psychotherapies remains low . A significant need exists to identify simple but effective implementation strategies to adopt complex practice s within complex systems of care . Emerging evidence suggests that facilitation may be an effective integrative implementation strategy for adoption of complex practice s. The current pilot examined the use of external facilitation for adoption of cognitive behavioral therapy ( CBT ) in 20 Department of Veteran Affairs ( VA ) clinics . Methods The 20 clinics were paired on facility characteristics , and 23 clinicians from these were trained in CBT . A clinic in each pair was r and omly selected to receive external facilitation . Quantitative methods were used to examine the extent of CBT implementation in 10 clinics that received external facilitation compared with 10 clinics that did not , and to better underst and the relationship between individual providers ' characteristics and attitudes and their CBT use . Costs of external facilitation were assessed by tracking the time spent by the facilitator and therapists in activities related to implementing CBT . Qualitative methods were used to explore context ual and other factors thought to influence implementation . Results Examination of change scores showed that facilitated therapists averaged an increase of 19 % [ 95 % CI : ( 2 , 36 ) ] in self-reported CBT use from baseline , while control therapists averaged a 4 % [ 95 % CI : ( -14 , 21 ) ] increase . Therapists in the facilitated condition who were not providing CBT at baseline showed the greatest increase ( 35 % ) compared to a control therapist who was not providing CBT at baseline ( 10 % ) or to therapists in either condition who were providing CBT at baseline ( average 3 % ) . Increased CBT use was unrelated to prior CBT training . Barriers to CBT implementation were therapists ' lack of control over their clinic schedule and poor communication with clinical leaders . Conclusions These findings suggest that facilitation may help clinicians make complex practice changes such as implementing an evidence -based psychotherapy . Furthermore , the substantial increase in CBT usage among the facilitation group was achieved at a modest cost Background Despite the burgeoning number of well-vali date d interventions that have been shown in r and omized trials to produce superior outcomes compared to usual services , it is estimated that only 10 % of public systems deliver evidence -based mental health services . In California , for example , more than 15,000 children are placed in group homes or residential centers with some evidence of iatrogenic effects . The present study evaluates the willingness among county leaders of child public service systems to adopt a new evidence -based model , Multidimensional Treatment Foster Care , ( MTFC ) , as a way to decrease the prevalence of out-of-home placements . Specifically , the study examines how county-level socio-demographic factors and child public service system leaders ' perceptions of their county 's organizational climate influence their decision of whether or not to consider adopting MTFC . Methods Two levels were examined in this study : Stable and historical factors from 40 California counties gathered from public records including population size , number of entries into out-of-home care , financing of mental health services , and percent minority population ; and system leaders ' perceptions of their county 's organizational climate and readiness for change measured via a web-based survey . The number of days-to-consent was the primary outcome variable defined as the duration of time between being notified of the opportunity to implement MTFC and the actual signing of a consent form indicating interest in considering implementation . Survival analysis methods were used to assess the predictors of this time-to-event measure . The present study is part of a larger r and omized trial comparing two methods of implementation where counties are r and omized to one of three time cohorts and two implementation conditions . Results The number of entries into care was the primary predictor of days-to-consent . This variable was significantly correlated to county size . System leader 's perceptions of positive climate and organizational readiness for change also contributed to but did not mediate or moderate the days-to-consent . Conclusions System leaders ' decision to consider implementing a new evidence -based model was influenced most by their objective need for the program and next by their perception of the county 's organizational climate and motivation to change . These findings highlight the importance of underst and ing the fit between the needs of the systems or agencies and the potential for addressing those needs with the proposed new program OBJECTIVE The objective of this study was to measure dietitians ' perceptions , attitudes , and knowledge of evidence -based practice ( PAK score ) , and to determine whether antecedent factors ( eg , sociodemographic characteristics , education and training , professional experiences , and employment setting ) predicted PAK score . DESIGN This cross-sectional , descriptive study used the Dietitian Research Involvement Survey following the Tailored Design Method . SUBJECTS/ SETTING This study surveyed 500 r and omly selected registered dietitians from seven dietetic practice groups of the American Dietetic Association . STATISTICAL ANALYSES PERFORMED Bivariate relationships were examined between antecedent factors and PAK score . Multiple linear regression analyses were conducted to test whether these factors predicted PAK score . RESULTS Higher PAK scores were associated with registered dietitians who completed more years of education ( r=0.28 , P<.0005 ) , had taken a research course ( r=0.28 , P<.0005 ) , frequently read research articles ( r=0.41 , P<.0005 ) , earned an advanced-level board certification ( r=0.18 , P=.004 ) , worked full-time ( r=0.26 , P<.0005 ) , or belonged to professional organizations ( r=0.18 , P=.003 ) . The strongest predictors for PAK score were \" last time read research \" ( beta=.33 , P<.0005 ) , work status ( beta=.20 , P<.0005 ) , level of education ( beta=.19 , P=.001 ) , and association memberships ( beta=.14 , P=.01 ) . CONCLUSIONS Results indicated that dietitians ' ability to incorporate an evidence -based approach is largely determined by their education and training , work experience , and professional association involvement . This study identified a need to integrate concepts and principles of evidence -based practice into dietetics curriculums so that practitioners are able to routinely apply research findings to clinical practice Background The Worksite Health Promotion Capacity Instrument ( WHPCI ) was developed to assess two key factors for effective worksite health promotion : collective willingness and the systematic implementation of health promotion activities in companies . This study evaluates the diagnostic qualities of the WHPCI based on its subscales Health Promotion Willingness and Health Promotion Management , which can be used to place companies into four different categories based on their level of health promotion capacity . Methods Psychometric evaluation was conducted using exploratory factor and reliability analyses with data taken from a r and om sample of managers from n = 522 German information and communication technology ( ICT ) companies . Receiver operating characteristic ( ROC ) analyses were conducted to determine further diagnostic qualities of the instrument and to establish the cut-off scores used to determine each company 's level of health promotion capacity . Results The instrument 's subscales , Health Promotion Willingness and Health Promotion Management , are based on one-dimensional constructs , each with very good reliability ( Cronbach 's alpha = 0.83/0.91 ) . ROC analyses demonstrated satisfactory diagnostic accuracy with an area under the curve ( AUC ) of 0.76 ( SE = 0.021 ; 95 % CI 0.72 - 0.80 ) for the Health Promotion Willingness scale and 0.81 ( SE = 0.021 ; 95 % CI 0.77 - 0.86 ) for the Health Promotion Management scale . A cut-off score with good sensitivity ( 71%/76 % ) and specificity ( 69%/75 % ) was determined for each scale . Both scales were found to have good predictive power and exhibited good efficiency . Conclusions Our findings indicate preliminary evidence for the validity and reliability of both subscales of the WHPCI . The goodness of each cut-off score suggests that the scales are appropriate for determining companies ' levels of health promotion capacity . Support in implementing ( systematic ) worksite health promotion can then be tailored to each company 's needs based on their current capacity level Background Psychological models are used to underst and and predict behaviour in a wide range of setting s , but have not been consistently applied to health professional behaviours , and the contribution of differing theories is not clear . This study explored the usefulness of a range of models to predict an evidence -based behaviour -- the placing of fissure sealants . Methods Measures were collected by postal question naire from a r and om sample of general dental practitioners ( GDPs ) in Scotl and . Outcomes were behavioural simulation ( scenario decision-making ) , and behavioural intention . Predictor variables were from the Theory of Planned Behaviour ( TPB ) , Social Cognitive Theory ( SCT ) , Common Sense Self-regulation Model ( CS-SRM ) , Operant Learning Theory ( OLT ) , Implementation Intention ( II ) , Stage Model , and knowledge ( a non-theoretical construct ) . Multiple regression analysis was used to examine the predictive value of each theoretical model individually . Significant constructs from all theories were then entered into a ' cross theory ' stepwise regression analysis to investigate their combined predictive value Results Behavioural simulation - theory level variance explained was : TPB 31 % ; SCT 29 % ; II 7 % ; OLT 30 % . Neither CS-SRM nor stage explained significant variance . In the cross theory analysis , habit ( OLT ) , timeline acute ( CS-SRM ) , and outcome expectancy ( SCT ) entered the equation , together explaining 38 % of the variance . Behavioural intention - theory level variance explained was : TPB 30 % ; SCT 24 % ; OLT 58 % , CS-SRM 27 % . GDPs in the action stage had significantly higher intention to place fissure sealants . In the cross theory analysis , habit ( OLT ) and attitude ( TPB ) entered the equation , together explaining 68 % of the variance in intention . Summary The study provides evidence that psychological models can be useful in underst and ing and predicting clinical behaviour . Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that may predict clinical behaviour and so provide possible targets for knowledge translation interventions . Results suggest that more evidence -based behaviour may be achieved by influencing beliefs about the positive outcomes of placing fissure sealants and building a habit of placing them as part of patient management . However a number of conceptual and method ological challenges remain This paper describes findings from the Community Youth Development Study ( CYDS ) , a r and omized controlled trial of the Communities That Care ( CTC ) prevention system , on the adoption and implementation fidelity of science-based prevention programming in 24 communities . Data were collected using the Community Re source Documentation ( CRD ) , which entailed a multi-tiered sampling process and phone and web-based surveys with directors of community-based agencies and coalitions , school principals , service providers , and teachers . Four years after the initiation of the CTC prevention system , the results indicated increased use of tested , effective prevention programs in the 12 CTC intervention communities compared to the 12 control communities , and significant differences favoring the intervention communities in the numbers of children and families \n Output:\n " }, { "from": "agent", "value": "Results indicate that organization , provider , and innovation-level constructs have the greatest number of measures available for use , whereas structural and patient-level constructs have the least .\nAdditionally , relatively few measures demonstrated criterion validity , or reliable association with an implementation outcome ( e.g. , fidelity ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A classical treatment for chronic adult periodontitis consists of four to six consecutive sessions of scaling and root planing at a 1- to 2-week interval . Such a so-called \" quadrant or sextant therapy \" might result in a reinfection of a previously disinfected area by bacteria from an untreated region . The purpose of this study was to investigate , over an 8-month period , the clinical benefits of full-mouth disinfection within a 24-hour period in the control of chronic periodontitis . Ten adult patients with advanced chronic periodontitis were r and omly assigned to a test and a control group . The control group received the st and ard scheme of initial periodontal therapy , consisting of scaling and root planing of the four quadrants was performed within 24 hours and immediately followed by a thorough supra- and subgingival chlorhexidine application to limit any transfer of bacteria . The latter involved tongue brushing with a 1 % chlorhexidine gel for 60 seconds , mouthrinsing with a 0.2 % chlorhexidine solution twice for 60 seconds , repeated subgingival irrigation of all pockets with a 1 % chlorhexidine gel ( 3 times within 10 minutes ) , and mouthrinsing twice daily with a 0.2 % chlorhexidine solution during 2 weeks . In addition , both groups received thorough oral hygiene instructions . The plaque index , gingival index , probing depth , gingival recession , and bleeding on probing were recorded prior to professional cleaning and at 1 , 2 , 4 , and 8 months afterwards . Although the test group scored higher plaque indices than the control group , especially at months 2 and 4 , the gingival index and bleeding tendency showed similar improvements with time . However , when the gingival/plaque ratio was considered , the latter was lower in the test group at all follow-up visits . For pockets > or = 7 mm , full-mouth disinfection showed a significantly ( P = 0.01 ) higher reduction in probing depth at each follow-up visit with , at month 8 , a reduction of 4 mm ( from 8 mm to 4 mm ) , in comparison to 3 mm ( from 8 mm to 5 mm ) for the classical therapy . The increase in gingival recession in the full-mouth disinfection group remained below 0.7 mm , while in the control group it reached 1.9 mm after 8 months . This result ed in a gain of clinical attachment level of 3.7 mm for the test group versus 1.9 mm for the control group . A radiographical examination also indicated a superior improvement for the test group when compared to the control group . This pilot study suggests that a full-mouth disinfection in one day results in an improved clinical outcome in chronic periodontitis as compared to scalings per quadrant at 2-week intervals over several weeks A treatment for periodontal infections often consists of consecutive rootplanings ( per quadrant , at a 1- to 2-week interval ) , without a proper disinfection of the remaining intra-oral niches ( untreated pockets , tongue , saliva , mucosa and tonsils ) . Such an approach , could theoretically lead to a reinfection of previously-treated pockets . The present study aims to examine the effect of a full-mouth disinfection on the microbiota in the above-mentioned niches . Moreover , the clinical benefit of such an approach was investigated . 16 patients with severe periodontitis were r and omly allocated to a test and a control group . The patients from the control group were scaled and rootplaned , per quadrant , at 2-week intervals and obtained oral hygiene instructions . The patients from the test group received a full-mouth disinfection consisting of : scaling and rootplaning of all pockets in 2 visits within 24 h , in combination with tongue brushing with 1 % chlorhexidine gel for 1 min , mouth rinsing with a 0.2 % chlorhexidine solution for 2 min and subgingival irrigation of all pockets ( 3x in 10 min ) with 1 % chlorhexidine gel . Besides oral hygiene , the test group rinsed 2x daily with 0.2 % chlorhexidine and sprayed the tonsils with a 0.2 % chlorhexidine for 2 months . Plaque sample s ( pockets , tongue , mucosa and saliva ) were taken at baseline and after 2 and 4 months , and changes in probing depth , attachment level and bleeding on probing were reported . The full-mouth disinfection result ed in a statistically significant additional reduction/elimination of periodontopathogens , especially in the subgingival pockets , but also in the other niches . These microbiological improvements were reflected in a statistically-significant higher probing depth reduction and attachment gain in the test patients . These findings suggest that a disinfection of all intra-oral niches within a short time span leads to significant clinical and microbiological improvements for up to 4 months OBJECTIVES The beneficial effects of the one-stage , full-mouth disinfection remain controversial in the scientific literature . This might be due to the fact that an entire mouth disinfection with the use of antiseptics has been confused with a full-mouth scaling and root planing . This parallel , single blind RCT study aim ed to compare several full-mouth treatment strategies with each other . MATERIAL AND METHODS Seventy-one patients with moderate periodontitis were r and omly allocated to one of the following treatment strategies : scaling and root planing , quadrant by quadrant , at two-week intervals ( negative control , NC ) , full-mouth scaling and root planing within 2 consecutive days ( FRP ) , or three one-stage , full-mouth disinfection ( FM ) protocol s within 2 consecutive days applying antiseptics to all intra-oral niches for periopathogens using as antiseptics : chlorhexidine ( FMCHX ) for 2 months , amine fluoride/stannous fluoride for 2 months ( FMF ) , or chlorhexidine for 2 months followed by amine fluoride/stannous fluoride for another 6 months ( FMCHX+F ) . At baseline and after 2 , 4 , and 8 a series of periodontal parameters were recorded . RESULTS All treatment strategies result ed in significant ( p<0.05 ) improvements of all clinical parameters over the entire duration of the study . Inter-treatment differences were often encountered . The NC group nearly always showed significant smaller improvements than the two CHX groups . The differences between the FRP or FM groups , and the two CHX groups only sporadically reached a statistical significance . CONCLUSION These observations indicate that the benefits of the \" OSFMD \" protocol are partially due to the use of the antiseptics and partially to the completion of the therapy in a short time Previous studies using correlation or regression analysis have showed that treatment effects measured by the change in clinical parameters are often associated with baseline values of the same parameters . These studies , however , have a method ological weakness . Correlation/regression between baseline measures and the derived change variable invali date s the statistical procedures of testing the null hypothesis : that the coefficient of correlation/regression is zero . This is due to the phenomenon of mathematical coupling . To investigate the impact that this has on the observed correlation/regression coefficient when in reality this is zero , we used r and om simulations of hypothetical data to model the treatment of periodontal pockets . Results showed a strong probability of obtaining statistically significant correlation/regression coefficients . To separate this artificial effect of mathematical coupling from the true underlying biological relationship , one must apply appropriate analytical strategies to re-evaluate previous evidence within the periodontal literature BACKGROUND / AIMS Recent studies reported significant additional clinical and microbiological improvements when severe adult periodontitis was treated by means of a \" one-stage full-mouth \" disinfection instead of a st and ard treatment strategy with consecutive root planings quadrant per quadrant . The one stage full-mouth disinfection procedure involves scaling and root planing of all pockets within 24 h in combination with an extensive application of chlorhexidine to all intra-oral niches such as periodontal pockets , tongue dorsum , tonsils ( chairside , and at home for 2 months ) . This study aims to examine the relative importance of the use of chlorhexidine in the one stage full-mouth disinfection protocol . METHODS Therefore , 3 groups of 12 patients each with advanced periodontitis were followed , both from a clinical and microbiological point of view , over a period of 8 months . The patients from the control group were scaled and root planed , quadrant per quadrant . at two-week intervals . The 2 other groups underwent a one stage full-mouth scaling and root planing ( all pockets within 24 h ) with ( Fdis ) or without ( FRp = full-mouth root planing ) the adjunctive use of chlorhexidine . At baseline and after 1 , 2 , 4 and 8 months , the following clinical parameters were recorded : plaque and gingivitis indices , probing depth , bleeding on probing and clinical attachment level . Microbiological sample s were taken from different intra-oral niches ( tongue , mucosa , saliva and pooled sample s from single- and multi-rooted teeth ) . The sample s were cultured on selective and non-selective media in order to evaluate the number of CFU/ml for the key-periodontopathogens . At baseline , an anonymous question naire was given to the patients to record the perception of each treatment ( post operative pain , fever , swelling etc . ) . RESULTS All 3 treatment strategies result ed in significant improvements for all clinical parameters , but the Fdis and FRp patients reacted always significantly more favourably than the control group , with an additional probing depth reduction of + /- 1.5 mm and an additional gain in attachment of + /- 2 mm ( for pockets > or = 7 mm ) . Also from a microbiological point of view both the FRp and Fdis patients showed additional improvements when compared to the control group , as well in the reduction of spirochetes and motile organisms as in the number of CFU/ml of the key-pathogens , especially when the subgingival plaque sample s were considered . The differences between FRp and Fdis patients were negligible . CONCLUSIONS These findings suggest that the benefits of a \" one-stage full-mouth disinfection \" in the treatment of patients suffering from severe adult periodontitis probably results from the full-mouth scaling and root planing within 24 h rather than the beneficial effect of chlorhexidine . The raise in body temperature the second day after the full-mouth scaling and root planing seems to indicate a Shwartzman reaction OBJECTIVES The aim of this study was to determine whether same-day full-mouth scaling and root planing ( FM-SRP ) and quadrant scaling and root planing ( Q-SRP ) result ed in variations in the systemic humoral immune response dynamics ( antibody titres and avidity ) during active treatment and 3 and 6 months post-therapy . MATERIAL S AND METHODS Forty patients with chronic periodontitis were recruited into this study . Subjects were r and omised into two groups and received either scaling and root planing quadrant by quadrant at 2-weekly intervals ( Q-SRP group ) or same-day full-mouth scaling and root planing ( FM-SRP group ) . Clinical measurements and serum sample s were obtained at baseline and approximately 6 weeks after the last clinical intervention ( R1 ) and 6 months after the initiation of therapy ( R2 ) . Furthermore , serum sample s were obtained from each patient undergoing therapy ( Q-SRP and FM-SRP ) at 3 bi-weekly instances so as to determine the short-term effects of each session of scaling and root planing on the dynamics of the humoral immune response . Serum antibody titre was assayed by enzyme-linked immunosorbent assay ( ELISA ) and antibody avidity was measured by thiocyanate dissociation against five putative periodontal pathogens : Porphyromonas gingivalis ; Actinobacillus actinomycetemcomitans ; Prevotella intermedia ; Treponema denticola and Bacteroides forsythus . RESULTS Both therapies result ed in similar antibody titre reductions against the majority of the organisms tested and although there was a distinct trend for antibody avidity to increase following therapy , this was not found to be statistically significant , reflecting marked inter-individual variation . In addition , no evidence emerged from this study to support increased antibody titres following the active phases of both treatment approaches due to an inoculation effect . Nevertheless , significant short-term increases in antibody avidity to most test bacteria were noted for both treatment strategies . CONCLUSION Both therapies were associated with a reduction in antibody titres and an increase in the binding ability or avidity of antibodies , but there was a marked inter-subject variability and statistical significance was reached for only some of the test bacteria . No significant differences in the humoral antibody dynamics were found between the two treatment approaches BACKGROUND The aim of the present study was to evaluate the effectiveness of non-surgical mechanical instrumentation at 2 different time intervals on short-term healing and to assess patient reactions following non-surgical periodontal therapy . METHODS The study population consisted of 100 patients with moderate periodontal disease . Patients were equally distributed into 2 groups , treated daily or weekly . The daily group received full-mouth daily scaling and root planing for 4 consecutive days . The weekly group was treated once a week for 4 weeks . All patients were asked for objective ( lymphadenopathy , aphthous stomatitis , and edema ) and subjective ( fatigue , pain , pruritus , burning sensation , and dentinalgia ) reactions . Clinical measurements of plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , bleeding on probing ( BOP ) , and gingival recession ( GR ) were taken at baseline and 3 months after treatment . All of the objective and subjective reactions were recorded after each treatment session . RESULTS The results of our study revealed a significant decrease in PI , GI , BOP , and PD measurements at the end of the third month , but no significant changes in GR . The incidence of subjective and objective reactions was higher in the daily treated group compared to those in the weekly group . Most of these complaints were observed after the third treatment session . CONCLUSIONS Within the limits of this study , no differences were observed between the study groups when the clinical parameters were evaluated . \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS In adults with chronic periodontitis only minor differences in treatment effects were observed between the treatment strategies" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To quantify the effect on reproductive outcome of culturing and selecting embryos using a novel time-lapse monitoring system ( TMS ) . DESIGN Retrospective observational cohort study . SETTING University-affiliated private center . PATIENT(S ) Donation and autologous intracytoplasmic sperm injection ( ICSI ) cycles from ten IVF clinics using similar procedures , cultured in TMS ( n = 1,390 ) or in a st and ard incubator ( SI ; n = 5,915 ) . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Clinical pregnancy rate confirmed by ultrasound in week 7 . RESULT ( S ) A logistic regression analysis , which included all significant confounding factors , was used to evaluate the effect of culturing and selecting embryos with the use of TMS . Comparing clinical pregnancy rates per oocyte retrieval with TMS and SI treatments gave a crude effect of odds ratio [ OR ] 1.190 ( 95 % confidence interval [ CI ] 1.058 - 1.337 ) . Oocyte source , maternal age , day of transfer , and number of retrieved oocytes were identified as significant confounding factors . After accounting for confounding factors , the effect of TMS culture was OR 1.201 ( 95 % CI 1.059 - 1.363 ) . Limiting analysis to treatments with embryo transfer and including number of transferred embryos as a confounding factor likewise gave a significant effect of TMS with OR 1.157 ( 95 % CI 1.018 - 1.315 ) . CONCLUSION ( S ) Analysis of retrospective data indicated that culturing and selecting embryos by TMS significantly improved the relative probability of clinical pregnancy ( + 20.1 % per oocyte retrieval , + 15.7 % per embryo transfer ) . The elevated clinical pregnancy rate was attributed to a combination of stable culture conditions and the use of morphokinetic parameters for embryo selection OBJECTIVE Both pronuclear morphology and early zygote cleavage have been used in combination with day 3 criteria to predict implantation and pregnancy . However , in routine practice , it is impractical to use both these criteria to select embryos on day 3 . The objective of the present study was to find which of the two criteria is more predictive in terms of implantation and pregnancy . DESIGN R and omized study . SETTING Hospital-based fertility center . PATIENT(S ) A total of 330 IVF/ICSI patient cycles . INTERVENTION(S ) Patients were r and omized to two groups . The embryos of one group were classified into subgroups A , B , and C based on pronuclear morphology ( group 1 ) and the embryos of the second group were classified into subgroups A , B , and C based on early cleavage status ( group 2 ) . MAIN OUTCOME MEASURE(S ) Comparisons were made of implantation and pregnancy rates between groups 1 and 2 , between subgroups within each group , and between the corresponding subgroups of groups 1 and 2 . Progression of zygotes from day 1 to day 3 in group 1 was recorded , and retrospective analysis of pronuclear morphology of zygotes in group 2 was performed . RESULT ( S ) The overall implantation and pregnancy rates tended to be slightly higher for group 1 compared to group 2 patients , but not statistically significant . Further , there was no significant difference between the corresponding subgroups . Implantation and pregnancy rates of subgroup A zygotes from each group were significantly higher ( P<.01 ) than the rates of subgroup C. CONCLUSION ( S ) There was no significant difference between the two groups in terms of implantation and pregnancy . However , pronuclear morphology is a more satisfactory criterion than early cleavage to assist embryo selection on day 3 . This is because zygotes with early cleavage ability can be identified from their pronuclear morphology . Thus , observation for early cleavage on day 1 and assessment of progression of embryos on day 2 in addition to pronuclear morphology scoring is not necessary in the selection of embryos for transfer on day 3 OBJECTIVE To evaluate embryos with direct cleavage ( ≤5 hours ) from two to three cells ( DC2 - 3 ) and correlate this morphokinetic parameter to implantation and ongoing pregnancy . DESIGN Clinical multicenter retrospective study . SETTING Private in vitro fertilization ( IVF ) centers . PATIENT(S ) From three clinics , a total of 979 treatments including 5,225 embryos using autologous or donated oocytes , of which 1,659 embryos were transferred . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Clinical pregnancy confirmed by ultrasound in week 7 . RESULT ( S ) Of the total embryo cohort , 715 ( 13.7 % ) underwent direct cleavage from two to three cells , 1,659 embryos were transferred to recipients , and 109 of the transferred embryos cleaved directly from two to three cells ( 6.6 % ) . Only one DC2 - 3 embryo was known to result in a clinical pregnancy ( 1 % ) and 80 ( 73.4 % ) DC2 - 3 embryos did not implant . Of the 1,550 embryos transferred not showing DC2 - 3 , 203 embryos were from treatments with 100 % implantation ( 13.1 % ) , and 804 ( 51.8 % ) embryos did not implant . The known implantation rate of DC2 - 3 embryos was statistically significantly lower than for embryos with a normal cleavage pattern ( 1.2 % vs. 20.2 % , respectively ) . CONCLUSION ( S ) Embryos with DC2 - 3 had a statistically significantly lower implantation rate than embryos with a normal cleavage pattern , suggesting that rejection of these embryos for transfer could improve the implantation rate BACKGROUND Time-lapse observation presents an opportunity for optimizing embryo selection based on morphological grading as well as providing novel kinetic parameters , which may further improve accurate selection of viable embryos . The objective of this retrospective study was to identify the morphokinetic parameters specific to embryos that were capable of implanting . In order to compare a large number of embryos , with minimal variation in culture conditions , we have used an automatic embryo monitoring system . METHODS Using a tri-gas IVF incubator with a built-in camera design ed to automatically acquire images at defined time points , we have simultaneously monitored up to 72 individual embryos without removing the embryos from the controlled environment . Images were acquired every 15 min in five different focal planes for at least 64 h for each embryo . We have monitored the development of transferred embryos from 285 couples undergoing their first ICSI cycle . The total number of transferred embryos was 522 , of which 247 either failed to implant or fully implanted , with full implantation meaning that all transferred embryos in a treatment implanted . RESULTS A detailed retrospective analysis of cleavage times , blastomere size and multinucleation was made for the 247 transferred embryos with either failed or full implantation . We found that several parameters were significantly correlated with subsequent implantation ( e.g. time of first and subsequent cleavages as well as the time between cleavages ) . The most predictive parameters were : ( i ) time of division to 5 cells , t5 ( 48.8 - 56.6 h after ICSI ) ; ( ii ) time between division to 3 cells and subsequent division to 4 cells , s2 ( ≤ 0.76 h ) and ( iii ) duration of cell cycle two , i.e. time between division to 2 cells and division to 3 cells , cc2 ( ≤ 11.9 h ) . We also observed aberrant behavior such as multinucleation at the 4 cell stage , uneven blastomere size at the 2 cell stage and abrupt cell division to three or more cells , which appeared to largely preclude implantation . CONCLUSIONS The image acquisition and time-lapse analysis system makes it possible to determine exact timing of embryo cleavages in a clinical setting . We propose a multivariable model based on our findings to classify embryos according to their probability of implantation . The efficacy of this classification will be evaluated in a prospect i ve r and omized study that ultimately will determine if implantation rates can be improved by time-lapse analysis BACKGROUND This study was undertaken to determine what characteristics should be recorded on which days to build a predictive model for selection of Day 3 embryos . METHODS Embryos failing to form a clinical sac or that formed a viable fetus ( to > or = 12 weeks ) , and transferred singly ( n = 269 ) or in pairs ( n = 1326 ) were scored for early cleavage and pronuclear status on Day 1 , and cell number , fragmentation , and symmetry on Days 2 and 3 , with number of nuclei per blastomere also recorded on Day 2 . Seven c and i date models were identified using a priori clinical knowledge and univariate analyses . Each model was fit on a training-set and evaluated on a test-set with resampling , with discrimination assessed using the area under the ROC curve ( AUC ) and calibration assessed using the Hosmer-Lemeshow statistics . RESULTS Models built using Day 1 , 2 or 3 scores independently on the 30 re sample d data sets showed that Day 1 evaluations provided the poorest predictive value ( median AUC = 0.683 versus 0.729 and 0.725 , for Day 2 and 3 ) . Combining information from Day 1 , 2 and 3 marginally improved discrimination ( median AUC = 0.737 ) . Using the final Day 3 model fitted on the whole data set , the median AUC was 0.732 ( 95 % CI , 0.700 - 0.764 ) , and 68.6 % of embryos would be correctly classified with a cutoff probability equal to 0.3 . CONCLUSIONS Day 2 or Day 3 evaluations alone are sufficient for morphological selection of cleavage stage embryos . The derived regression coefficients can be used prospect ively in an algorithm to rank embryos for selection STUDY QUESTION Can the pronuclei ( PN ) morphology and the time of PN breakdown ( PNB ) predict the potential of embryos to result in live birth ? SUMMARY ANSWER In comparison to embryos result ing in no live birth , PNB occurred significantly later in embryos result ing in live birth and never earlier than 20 h 45 min . None of the tested scoring systems were shown to predict the live birth outcome in a time-lapse set-up . WHAT IS KNOWN ALREADY The PN morphology is supported as a prominent embryo selection parameter in single light microscopy observations , although controversial results have been reported . STUDY DESIGN , SIZE , DURATION This was a prospect i ve study of 159 embryos , all of which were later transferred . The PN morphology of 46 embryos which result ed in live birth was compared with that of 113 embryos which result ed in no live birth . PARTICIPANTS , SETTING From 1 March 2010 to 30 August 2011 , 130 couples underwent fertility treatment by ICSI . Embryo culture was performed in a time-lapse set-up from fertilization to intrauterine transfer . PN morphological assessment was performed on every embryo replaced , using six different scoring systems at different times . MAIN RESULTS AND THE ROLE OF CHANCE No embryo with PNB earlier than 20 h 45 min result ed in live birth . All six PN assessment models showed no significant distribution of scores ( P = NS ) between the live birth and no live birth groups at 16 h post-fertilization ( PF ) , 18 h PF and 40 min before PNB . The outcomes of assessment s changed significantly ( P < 0.001 ) over time and the time of PNB was found to be the optimal stage to evaluate the PN morphology . LIMITATIONS , REASONS FOR CAUTION The study includes only embryos reaching the 4-cell stage after ICSI , and transferred at 44 h PF . WIDER IMPLICATION S OF THE FINDINGS The PN morphology changes over time , indicating that the single light microscopy observation approach is deficient in comparison to time-lapse . Although the assessment of the PN morphology does not improve embryo selection , the timing of PNB should be included in embryo selection parameters BACKGROUND The objective of this investigation was to determine the inter- and intraobserver agreement when assessing embryo quality . METHODS This investigation included 4002 cleaved embryos from 7535 oocytes retrieved in 688 patients undergoing IVF cycles in a multicentre trial . Embryos were evaluated locally at the inverted microscope at 28 , 44 and 68 h ( + /-1 h ) post-insemination . Digital images of the embryos were assessed central ly by three blinded embryologists . To assess reproducibility , 215 r and omly selected cleaved embryos from 33 patients were re-evaluated by the three central embryologists . RESULTS The interobserver agreement among the central embryologists ( using the same method of evaluation ; 2D images ) was good for classification of top- quality embryos ( kappa 0.71 - 0.73 ) , excellent for classification of normally developed embryos ( kappa 0.83 - 0.86 ) and good-excellent for classification of transferable embryos ( kappa 0.78 - 0.82 ) . The interobserver agreement between local and consoli date d central assessment ( different methods of evaluation , inverted microscopy versus 2D images ) was good for all three embryo classifications ( kappa 0. \n Output:\n " }, { "from": "agent", "value": "While several studies suggest higher implantation rates for fast-cleaving embryos and those with a timely duration ( i.e. all time points within the defined ranges ) of the 2-cell and 3-cell stages , no single morphokinetic parameter has been consistently shown to predict implantation potential .\nSparse , often incomplete and largely heterogeneous data suggest that TLM may be able to distinguish between high and low-implantation potential embryos ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The psychopharmacotherapy of somatoform disorders ( SD ; ICD-10 : F45 ) has been less frequently investigated and is not as well established as in other ( neurotic ) disorders of ICD-10 section F4 , i.e. generalized anxiety disorder ( GAD ; ICD-10 : F41.1 ) . The atypical compound opipramol is very often used to treat SD and GAD in clinical practice in Germany . However , state-of-the-art controlled clinical trials have not yet been performed . OBJECTIVES Two clinical trials were performed with the aim of confirming the efficacy and tolerability of opipramol in SD and GAD . METHODS Both trials were performed as r and omized , double-blind , placebo-controlled , multicenter studies . While the GAD trial was a three-arm study with opipramol ( 200 mg/day ) vs. placebo and alprazolam ( 2 mg/day ) for 28 days , the SD trial was a placebo-controlled two-arm study with a treatment duration of 42 days . Each group consisted of about 100 patients . RESULTS Significant differences ( alpha = 0.05 ) were found for the primary efficacy criteria ( HAMA total score in GAD , HAMA somatic subscore in SD ) and most of the secondary criteria in favor of the active drug therapies . Considerable differences between the psychopathology of SD and GAD were detected . CONCLUSION The well-tolerated anxiolytic opipramol is the first psychotropic drug with proven efficacy in somatoform disorders with effects on symptoms of somatization , anxiety , and depression . The compound is also effective and safe in GAD & NA ; In the double‐blind placebo‐controlled study presented here , the effects were investigated of a low dose of amitriptyline ( 75 mg ) in patients with chronic pain of various origins . The active drug was superior to placebo in reducing pain intensity . The reduction was small . In the second treatment week , the amitriptyline treated patients slept longer . No differences between active drug and placebo were found with respect to daily activities or use of analgesics . Based on our data and those of other studies , it is concluded that amitriptyline ( and other antidepressants ) in low doses does have a positive effect on the intensity and some other aspects of chronic pain , but that the effect is modest . It must be kept in mind that chronic pain is a very treatment‐resistant condition . Therefore , even modest positive effects may be worthwhile OBJECTIVE This pilot study explored the efficacy and tolerability of extended-release venlafaxine ( venlafaxine ER ) in anxious and /or depressed patients with multisomatoform disorder ( MSD ) . METHOD This 12-week , multicenter , r and omized , double-blind study evaluated adult primary care out patients with MSD and comorbid major depressive disorder , generalized anxiety disorder , or social anxiety disorder ( DSM-IV criteria ) . The intent-to-treat population included 112 patients ( venlafaxine ER , N = 55 ; placebo , N = 57 ) . The primary efficacy variable was the change in the 15-item Patient Health Question naire ( PHQ-15 ) somatic symptom severity score . Secondary outcomes included the Hamilton Rating Scale for Depression ( HAM-D-17 ) and for Anxiety ( HAM-A ) , Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales , McGill Quality of Life Question naire Physical Symptoms Scale ( MQOL-PS ) , and Medical Outcomes Study Short-Form 36-Item question naire ( MOS SF-36 ) . Data were collected from April 2003 to December 2003 . RESULTS The decline by week 12 in PHQ-15 scores was significant ( p < .0001 ) in both groups ; however , the difference between the venlafaxine ER and placebo groups ( -8.3 vs. -6.6 , respectively ) was not ( p = .097 ) . Improvement was greater with venlafaxine ER than placebo on the PHQ-15 pain subscale ( p = .03 ) , SF-36 bodily pain scale ( 26.1 vs. 14.5 , p = .03 ) , MQOL-PS ( -11.7 vs. -6.0 , p = .02 ) , HAM-A psychic anxiety subscale ( p = .02 ) , SF-36 mental component summary ( p = .03 ) , time to response ( 54 vs. 71 days , p = .01 ) , and CGI-I scale ( p = .009 ) . Venlafaxine ER was generally well tolerated . CONCLUSION These results suggest that venlafaxine ER may be effective in relieving some types of somatic physical symptoms , particularly pain , in patients with depression and /or anxiety disorders Abstract Rationale and objective . Preliminary data have shown that St John 's wort might possess some specific efficacy in patients with somatoform complaints . Therefore , the efficacy of the Hypericum extract LI 160 in patients with somatoform disorders should be studied in a double-blind placebo-controlled fashion . Methods . This was a multicentre , r and omised , placebo controlled , 6-week trial comparing the efficacy of LI 160 ( 600 mg/day ) and placebo in 151 out- patients suffering from somatization disorder ( ICD-10 : F45.0 ) , undifferentiated somatoform disorder ( F45.1 ) , or somatoform autonomic dysfunctions ( F45.3 ) . The primary outcome measure was the decrease of the Hamilton Anxiety Scale , subfactor somatic anxiety ( HAMA-SOM ) , during the trial period . Results . LI 160 was superior effective concerning the primary outcome criterion HAMA-SOM [ decrease from 15.39 ( SD 2.68 ) to 6.64 ( 4.32 ) in the Hypericum group and from 15.55 ( 2.94 ) to 11.97 ( 5.58 ) in the placebo group ( statistically significant difference , P=0.001 ) ] . This was corroborated by the result of a statistically significant superior efficacy in the outcome criteria additionally used such as Clinical Global Impression , HAMA-total score , HAMA , subscore psychic anxiety , Hamilton Depression Scale , Self-Report Symptom Inventory 90 items – revised ( SCL-90-R ) , and SCL-90-R , subscore somatic anxiety . The efficacy of LI 160 was preserved after splitting the population in those with mild and those with severe depressive symptoms . Tolerability of LI 160 was excellent . Conclusion . The data from this trial show excellent efficacy and tolerability for LI 160 in somatoform disorders . The efficacy is independent of an existing depressive mood . This is the first study showing the efficacy of a drug in patients with somatisation disorder independent of depressive symptomatology The reduction of pain by two antidepressants , clomipramine and mianserin , was , in this study on 253 patients with chronic idiopathic pain syndrome , found to be not better than a placebo when all patients were compared independently of the classification of pain . The improvement rate was around 40 % after 6 weeks of treatment when using a 50 % or better reduction in pain level . However , in patients who fulfilled a checklist definition of minor to major depression ( 30 % of the total patient material ) clomipramine was superior to mianserin and placebo with an improvement rate of 75 % after 6 weeks . Using pain curves over time as outcome measure in the various clinical pain categories it was found that both mianserin and clomipramine seemed superior to placebo in patients with tension headache , but in patients with low back pain syndrome placebo was superior to the two antidepressants . No difference among the three treatments was found in patients with burning mouth syndrome or in patients with abdominal pain . These differences underline the importance of study ing specific pain syndromes rather than composite groups of patients with idiopathic pain . The clinical significance of these pain curves needs further placebo controlled investigations The effects of domperidone , a peripherally acting dopamine antagonist , were compared with those of placebo in a double-blind r and omized study in 16 patients with idiopathic gastric stasis , chronic symptoms of “ nonulcer dyspepsia ” ( including nausea , vomiting , and abdominal pain ) , and altered gastroduodenal motility . Patients received either domperidone or placebo orally ( 20 mg before meals and at bedtime ) for six weeks . Symptoms were assessed by daily diaries kept by the patients for two weeks while receiving no medication for their gastrointestinal complaints ( baseline ) , and throughout the six-week treatment phase . Studies of gastric emptying of a radiolabeled solid-phase meal were performed at baseline and six weeks after treatment . All patients had delayed gastric emptying at baseline , defined as a half-emptying time of more than mean + 1 sd ( from studies of normal controls ) . An 18- to 24-hr recording of gastroduodenal motor function during fasting was also performed at baseline and after six weeks of either domperidone or placebo treatment . After six weeks of treatment , the symptom scores significantly improved in the domperidone group ( P<0.05 ) , but not in the placebo group . Gastroduodenal motor activity was unchanged from baseline recordings after six weeks . Solid-phase gastric emptying also showed no improvement in either the domperidone or placebo group of patients . Although domperidone therapy had no significant effect on motility , it appears to be an effective drug for the treatment of the symptoms of nonulcer dyspepsia Abstract Objectives : To compare the efficacy and tolerability of Hypericum perforatum ( St John 's wort extract ) with imipramine in patients with mild to moderate depression . Design : R and omised , multicentre , double blind , parallel group trial . Setting : 40 outpatient clinics in Germany . Participants : 324 out patients with mild to moderate depression . Intervention : 75 mg imipramine twice daily or 250 mg hypericum extract ZE 117 twice daily for 6 weeks . Main outcome measures : Hamilton depression rating scale , clinical global impression scale , and patient 's global impression scale . Results : Among the 157 participants taking hypericum mean scores on the Hamilton depression scale decreased from 22.4 at baseline to 12.00 at end point ; among the 167 participants taking imipramine they fell from 22.1 to 12.75 . Mean clinical global impression scores at end point were 2.22 out of 7 for the hypericum group and 2.42 for the imipramine group . On the 7 point self assessment s of global improvement completed by participants ( score of 1 indicating “ very much improved ” and 7 indicating “ very much deteriorated ” ) mean scores were 2.44 in the hypericum group and 2.60 in the imipramine group . None of the differences between treatment groups were significant . However , the mean score on the anxiety-somatisation subscale of the Hamilton scale ( 3.79 in the hypericum group and 4.26 in the imipramine group ) indicated a significant advantage for hypericum relative to imipramine . Mean scores on the 5 point scale used by participants to assess tolerability ( score of 1 indicating excellent tolerability and 5 indicating very poor tolerability ) were better for hypericum ( 1.67 ) than imipramine ( 2.35 ) . Adverse events occurred in 62/157 ( 39 % ) participants taking hypericum and in 105/167 ( 63 % ) taking imipramine . 4 ( 3 % ) participants taking hypericum withdrew because of adverse events compared with 26 ( 16 % ) taking imipramine . Conclusions : This Hypericum perforatum extract is therapeutically equivalent to imipramine in treating mild to moderate depression , but patients tolerate hypericum better Pain possesses both sensory and affective dimensions , which are highly correlated yet distinct . Comparison of these dimensions within experimental pain setting s has result ed in the construct of relative unpleasantness . Relative unpleasantness is defined as the amount of affective unpleasantness elicited for a given sensory magnitude . The aim of this study was to determine the relationship between affective and sensory components of evoked pain in subjects with fibromyalgia ( FM ) and healthy controls . Here we show that patients with FM unexpectedly display less relative unpleasantness than healthy controls in response to r and om noxious pressure stimuli . Relative unpleasantness was not correlated with distress , anxiety , or depression , which were pronounced in the FM group . Clinical pain in patients with FM was perceived to be more unpleasant than the evoked pain stimuli . These results are consistent with the concept that chronic pain may reduce the relative unpleasantness of evoked pain sensations BACKGROUND The German National Health Interview and Examination Survey ( GHS ) is the first government m and ated nationwide study to investigate jointly the prevalence of somatic and mental disorders within one study in the general adult population in Germany . This paper reports results from its Mental Health Supplement ( GHS-MHS ) on 4-week 12-month , and selected lifetime prevalence of a broad range of DSM-IV mental disorders , their co-morbidity and correlates in the community . METHODS The sample of the GHS-MHS ( n=4181 ; multistage stratified r and om sample drawn from population registries ; conditional response rate : 87.6 % ) can be regarded as representative for the German population aged 18 - 65 . Diagnoses are based on fully structured computer assisted clinical interviews ( M-CIDI ) , conducted by clinical ly trained interviewers \n Output:\n " }, { "from": "agent", "value": "The current review found very low- quality evidence for NGAs and low- quality evidence for NPs being effective in treating somatoform symptoms in adults when compared with placebo .\nFurthermore , the significant effects of antidepressant treatment have to be balanced against the relatively high rates of adverse effects .\nAdverse effects produced by medication can have amplifying effects on symptom perceptions , particularly in people focusing on somatic symptoms without medical causes .\nWe can only draw conclusions about short-term efficacy of the pharmacological interventions because no trial included follow-up assessment s. For each of the comparisons where there were available data on acceptability rates ( NGAs versus placebo , NPs versus placebo , TCAs versus other medication , and antidepressants versus a combination of an antidepressant and an antipsychotic ) , no clear differences between the intervention and comparator were found ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE This prospect i ve study evaluated the neurosensory recovery pattern of the inferior alveolar nerve following the bilateral sagittal split osteotomy ( BSSO ) . PATIENTS AND METHODS Forty-two consecutive patients undergoing BSSO were studied using five neurosensory tests : 1 ) static light touch , 2 ) moving touch discrimination , 3 ) two-point discrimination , 4 ) nociception , and 5 ) thermoreception . Intraoperative assessment of inferior alveolar nerve damage was made ; other variables recorded included type of fixation , age , concomitant procedures , advancement vs setback , and magnitude of the movement . A subjective question naire was completed by the patient . RESULTS The variables that affected neurosensory function following BSSO were degree of nerve damage and the amount of time elapsed following surgery . Larger myelinated fibers ( A-alpha ) recovered slower and to a lesser degree at all time intervals up to 2 years when compared with small myelinated and unmyelinated nerve fibers . The magnitude of nerve damage directly correlated with early neurosensory deficit , but equalized over time . CONCLUSION The long term ( 6 months and greater ) chance for neurosensory recovery is good despite intraoperative nerve manipulation . Patients seem to adapt and report normal neurosensory function even though objective testing indicates continued neurosensory deficit Three hundred seventeen normal fingers and 612 fingers in 153 h and s with carpal tunnel syndrome were tested for sensibility using the Weinstein Enhanced Sensory Test ( WEST ) with calibrated monofilaments , by static two-point discrimination ( s2PD ) and moving two-point discrimination ( m2PD ) , using the Disk-Criminator , and by Strauch 's ten test . Equivalent Semmes-Weinstein monofilament ( SWM ) test values were also determined as a gold st and ard for comparison . With both the WEST and SWM test values , the norms for interpretation have an unacceptably wide latitude because of the use of an ordinal scale of increasingly unequal intervals . With the WEST and Disk-Criminator tests , some cases of early sensory loss were missed . The SWM test apparatus , although producing relatively reliable values , is not easily portable , and its use is time-consuming in a busy office ; the WEST device is prohibitively expensive . The ten test is rapid , simple , and sensitive in evaluation . It measures sensibility on a continuous analog scale , and allows for multiple points of testing in the h and , with good inter- and intra-examiner reliability . It is accurate in detecting very early loss of sensibility . In addition , the ten test requires no instrumentation Objectives Semmes-Weinstein monofilaments are too long for use in parts of the oral cavity . 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 purpose s , classic Semmes-Weinstein monofilaments with 20 different diameters were cut to half their length ( ie , 19 mm ) and the bending forces were measured . 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 . 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 r and om staircase method . Results According to the forces needed to bend the half-cut filaments , they were renumbered from 2.55 to 6.86 . 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 ) . By contrast , the palatal posterior maxillary gingiva had a significantly higher FPT threshold compared with the other test sites ( P<0.001 ) . Discussion s The present study illustrated that in healthy participants , half-cut Semmes-Weinstein monofilaments reliably and easily assess TDT and FPT intraorally . A combined examination of sensory and pain thresholds using these filaments contributes to the clinical examination for orofacial pain The aim of this study was to conduct a prospect i ve clinical trial comparing the neurosensory function of the inferior alveolar nerve ( IAN ) after m and ibular advancement surgery with either bilateral sagittal split osteotomies ( BSSO ) or m and ibular distraction ostoegenesis ( MDO ) . 23 Class II m and ibular hypoplasia patients requiring m and ibular advancement were r and omized into two groups for either BSSO or MDO . Subjective and objective neurosensory evaluations were performed preoperatively and at the following postoperative times : 2 weeks ( TBD1 ) , 6 weeks ( TBD2 ) , 12 weeks ( TBD3 ) , 6 months ( TBD4 ) and 12 months ( TBD5 ) . Subjective evaluation included the use of a visual analogue scale ( VAS ) . Objective evaluation included the use of light touch ( LT ) , two-point discrimination ( 2PD ) and pain detection threshold ( PD ) tests . Intra-operative or postoperative complications were recorded . Using a mixed model , no significant differences were reported in subjective VAS scores and objective LT , 2PD and PD scores between the BSSO and MDO groups over 12 months ( p>0.05 ) . Common postoperative complications included localized wound infection ( BSSO=2 , MDO=6 ) and condylar resorption ( BSSO=1 , MDO=1 ) PURPOSE The purpose of this analysis was to compare the frequency and severity of nerve damage with rigid and wire fixation in patients participating in a prospect i ve , r and omized clinical trial . PATIENTS AND METHODS One hundred twenty-six patients who required a bilateral sagittal split osteotomy and m and ibular advancement were r and omly assigned to receive either rigid or wire fixation . Tactile sensation in the mental nerve region bilaterally was determined presurgically and throughout the subsequent 2 years by using monofilament detection and brush stroke direction . Neurosensory levels were compared between the types of fixation over time . RESULTS Evaluation with monofilament detection showed no significant difference between types of fixation throughout the 2-year follow-up . However , brush stroke determination showed significantly greater hypesthesia with rigid compared with wire fixation from 8 weeks through 2 years postoperatively . CONCLUSION Rigid fixation result ed in more anesthesia in the mental nerve distribution than wire fixation when tested with brush stroke direction . However , increased anesthesia was not present when measured with monofilament determination PURPOSE This study investigated neurosensory disturbances in patients after orthognathic surgery in relation to differences in m and ibular splitting methods and degree of surgical skill . PATIENTS AND METHODS Forty-five patients who had undergone bilateral sagittal split ramus osteotomies ( SSRO ) , and 21 ( group L ) who had undergone intraoral inverted L ramus osteotomies ( ILRO ) , were examined for postsurgical neurosensory disturbances . Twenty-two ( group S1 ) of the SSRO patients were treated by 11 surgeons who had little experience , and the others ( 23 patients ; group S2 ) were treated by 2 skilled surgeons who had considerable experience . One of the 2 skilled surgeons was the only surgeon carrying out the ILRO procedure . The neurosensory tests employed included light touching using a Semmes-Weinstein monofilament tester ( SW tester ) , electrical stimulation , and a question naire to determine changes in subjective sensations , at the time of each sensory evaluation . Neurosensory examinations were carried out bilaterally ( 132 sides ) at 1 , 3 , 6 , and 12 months after surgery . RESULTS More patients showed abnormal thresholds for the 2 measurement techniques in the SSRO group than in the ILRO group , and furthermore there were more such patients in group S1 than in group S2 , at each measurement point . At 6 months after surgery , the number of patients with reduced sensitivity was significantly higher in group S1 than in group L ( P < .05 ) . In the SSRO group at each measurement point , the thresholds for the lower lip and chin were unrelated to the set-back ( or advance ) distance . By contrast , in group L only at the 1-month evaluation point , the thresholds for the lower lip and chin were significantly raised in patients whose setback distances were larger than average ( P < .05 ) . CONCLUSIONS Postsurgical neurosensory disturbances of the lower lip and chin occur more frequently in SSRO patients treated by surgeons having little experience than in those treated by skilled surgeons , although the difference is not significant . Long-term prognosis for resolution of postsurgical neurosensory disturbances is better in ILRO patients than in SSRO patients . Although the width of movement of the split bone fragments has an influence on postsurgical neurosensory disturbances immediately after ILRO , the relationship becomes less obvious with time The criteria and scoring method for a system to evaluate the quality of r and omized control trials ( RCTs ) in dental research based on published reports is presented . This sytem is based on one devised for evaluation of RCTs in medicine . Items assessed in this system include r and omization and blinding procedures , subject selection criteria , treatment protocol s , and statistical analyses . Assessing the quality of RCTs can contribute to improved study design , implementation and reporting by investigators , and evaluation of reports by referees and editors of scientific journals Deficits in the neurosensory function ( NF ) of the inferior alveolar nerve ( IAN ) are often encountered after bilateral sagittal split osteotomy of the m and ible . A prospect i ve follow-up study was performed to examine the long-term effect of especially gentle h and ling of the soft tissues on the medial side of the ascending ramus . After the initial incision , the soft tissues of the ramus were either retracted extremely gently and minimally ( test side ) or , as was the earlier routine , more widely ( contralateral control side ) . NF was tested with 2-point discrimination ( 2-PD ) and vitality scanner tests ( VST ) preoperatively and four times postoperatively up to 1 year . Patients ' subjective sensations were also assessed . The results showed a difference between the sides , which was most distinct at the 6-month follow-up ( P=0.028 ) measured with VST , while 2-PD did not show any statistical differences . Our findings support the earlier intraoperative neurophysiologic reports that dissection trauma to the IAN around the m and ibular foramen may cause NF deficits in the IAN even before the actual splitting of the m and ible . Therefore , minimal distraction of the soft tissues in the ramus is indicated . Higher age is an evident risk factor , and subjective sensation correlates with 2-PD in the lower lip Sensory impairment after bilateral sagittal split osteotomy ( BSSO ) due to inferior alveolar nerve ( IAN ) lesions may be either temporary or permanent and either complete or partial . The aim of this prospect i ve study is to evaluate , by means of objective sensory testing , IAN sensory disturbances development in patients who underwent BSSO.IAN sensory disturbances development at the first week , fourth week , sixth month , and twelfth month of follow-up review in a group of 60 patients who underwent BSSO from January 1 , 1998 , to July 31 , 1999 , at the Maxillofacial Surgery Department of the “ La Sapienza ” University of Rome . The 60 patients were examined in the presurgical period ; the IAN functionality regarding thermal sensibility , nociception , and two-point discrimination , was assessed at follow-up in 120 sides . In our study the highest rate of spontaneous recovery of the entire IAN functionality was observed at the sixth month . This finding witnesses how neuropraxia and axonotmesis give a spontaneous recovery that most frequently occurs within 6 months from surgery , independently from age and sex of the patient . The persistence of anesthesia over 12 months could be a sign of neurotmesis PURPOSE The aim of this prospect i ve study was to objective ly evaluate the inferior alveolar nerve ( IAN ) sensory disturbances in patients who underwent sagittal split ramus osteotomy ( SSRO ) and its spontaneous recovery and to define the incidence of sensibility loss , time , and area at which the recovery occurs . PATIENTS AND METHODS Clinical evaluation of the IAN sensory disturbance was undertaken preoperatively and at the first week , fourth week , 2 months , and 6 months postoperatively in 30 patients who underwent SSRO at the Oral and Maxillofacial Surgery Division of the Araraquara Dental School -- Unesp and at the Plastic Surgery Division of the Medical Sciences School -- Unicamp . The 30 patients were examined at all periods regarding the IAN functionality by Semmes-Weinstein testing . RESULTS The mean age of the patients included in this study was 29.36 years old . All patients showed sensibility loss at the 7-day evaluation time . The comparison between sides , gender , and age did not show any significant difference . In most of the examined zone , the data collected at 6 months were statistically similar to the data collected at the preoperative period . All zones presented significant recovery , starting from 30 days after surgery . Twenty patients had total spontaneous recovery at the final period , in all examined zones . CONCLUSIONS The SSRO presents the disadvantage of temporary paresthesia ; however , spontaneous nerve function recovery does occur . The Semmes-Weinstein test is a reliable , inexpensive , and easy-to-apply tool , which can be used for clinical evaluation on a daily basis at \n Output:\n " }, { "from": "agent", "value": "Before surgery , the lowest detectable threshold corresponded to a mean of 0.07 to 0.16 g. At 1 month after surgery , the lowest detectable threshold averaged 6 g , and at 1 year after surgery , the mean value was 0.16 to 0.4 g. CONCLUSIONS After bilateral sagittal split osteotomy , at 1 month after surgery , the sensory threshold increases approximately 35- to 85-fold compared with the presurgery threshold .\nWithin 1 year , the threshold normally decreases almost to presurgery levels , representing 96 % to 98 % sensory recovery ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Allogeneic marrow transplantation can cure sickle cell disease ; however , HLA-matched donors are difficult to find , and the toxicities of myeloablative conditioning are prohibitive for most adults with this disease . We developed a nonmyeloablative bone marrow transplantation platform using related , including HLA-haploidentical , donors for patients with sickle cell disease . The regimen consisted of antithymocyte globulin , fludarabine , cyclophosphamide , and total body irradiation , and graft-versus-host disease prophylaxis with posttransplantation high-dose cyclophosphamide , mycophenolate mofetil , and tacrolimus or sirolimus . After screening 19 patients , we transplanted 17 , 14 from HLA-haploidentical and 3 from HLA-matched related donors . Eleven patients engrafted durably . With a median follow-up of 711 days ( minimal follow up 224 days ) , 10 patients are asymptomatic , and 6 patients are off immunosupression . Only 1 patient developed skin-only acute graft-versus-host disease that resolved without any therapy ; no mortality was seen . Nonmyeloablative conditioning with posttransplantation high-dose cyclophosphamide exp and s the donor pool , making marrow transplantation feasible for most patients with sickle cell disease , and is associated with a low risk of complications , even with haploidentical related donors . Graft failure , 43 % in haploidentical pairs , remains a major obstacle but may be acceptable in a fraction of patients if the majority can be cured without serious toxicities BACKGROUND The use of inhaled glucocorticoids for persistent asthma causes a temporary reduction in growth velocity in prepubertal children . The result ing decrease in attained height 1 to 4 years after the initiation of inhaled glucocorticoids is thought not to decrease attained adult height . METHODS We measured adult height in 943 of 1041 participants ( 90.6 % ) in the Childhood Asthma Management Program ; adult height was determined at a mean ( ±SD ) age of 24.9±2.7 years . Starting at the age of 5 to 13 years , the participants had been r and omly assigned to receive 400 μg of budesonide , 16 mg of nedocromil , or placebo daily for 4 to 6 years . We calculated differences in adult height for each active treatment group , as compared with placebo , using multiple linear regression with adjustment for demographic characteristics , asthma features , and height at trial entry . RESULTS Mean adult height was 1.2 cm lower ( 95 % confidence interval [ CI ] , -1.9 to -0.5 ) in the budesonide group than in the placebo group ( P=0.001 ) and was 0.2 cm lower ( 95 % CI , -0.9 to 0.5 ) in the nedocromil group than in the placebo group ( P=0.61 ) . A larger daily dose of inhaled glucocorticoid in the first 2 years was associated with a lower adult height ( -0.1 cm for each microgram per kilogram of body weight ) ( P=0.007 ) . The reduction in adult height in the budesonide group as compared with the placebo group was similar to that seen after 2 years of treatment ( -1.3 cm ; 95 % CI , -1.7 to -0.9 ) . During the first 2 years , decreased growth velocity in the budesonide group occurred primarily in prepubertal participants . CONCLUSIONS The initial decrease in attained height associated with the use of inhaled glucocorticoids in prepubertal children persisted as a reduction in adult height , although the decrease was not progressive or cumulative . ( Funded by the National Heart , Lung , and Blood Institute and the National Center for Research Re sources ; CAMP Clinical Trials.gov number , NCT00000575 . ) IMPORTANCE Myeloablative allogeneic hematopoietic stem cell transplantation ( HSCT ) is curative for children with severe sickle cell disease , but toxicity may be prohibitive for adults . Nonmyeloablative transplantation has been attempted with degrees of preparative regimen intensity , but graft rejection and graft-vs-host disease remain significant . OBJECTIVE To determine the efficacy , safety , and outcome on end-organ function with this low-intensity regimen for sickle cell phenotype with or without thalassemia . DESIGN , SETTING , AND PARTICIPANTS From July 16 , 2004 , to October 25 , 2013 , 30 patients aged 16 - 65 years with severe disease enrolled in this nonmyeloablative transplant study , consisting of alemtuzumab ( 1 mg/kg in divided doses ) , total-body irradiation ( 300 cGy ) , sirolimus , and infusion of unmanipulated filgrastim mobilized peripheral blood stem cells ( 5.5 - 31.7 × 10(6 ) cells/kg ) from human leukocyte antigen-matched siblings . MAIN OUTCOMES AND MEASURES The primary end point was treatment success at 1 year after the transplant , defined as a full donor-type hemoglobin for patients with sickle cell disease and transfusion independence for patients with thalassemia . The secondary end points were the level of donor leukocyte chimerism ; incidence of acute and chronic graft-vs-host disease ; and sickle cell-thalassemia disease-free survival , immunologic recovery , and changes in organ function , assessed by annual brain imaging , pulmonary function , echocardiographic image , and laboratory testing . RESULTS Twenty-nine patients survived a median 3.4 years ( range , 1 - 8.6 ) , with no nonrelapse mortality . One patient died from intracranial bleeding after relapse . As of October 25 , 2013 , 26 patients ( 87 % ) had long-term stable donor engraftment without acute or chronic graft-vs-host disease . The mean donor T-cell level was 48 % ( 95 % CI , 34%-62 % ) ; the myeloid chimerism levels , 86 % ( 95 % CI , 70%-100 % ) . Fifteen engrafted patients discontinued immunosuppression medication with continued stable donor chimerism and no graft-vs-host disease . The normalized hemoglobin and resolution of hemolysis among engrafted patients were accompanied by stabilization in brain imaging , a reduction of echocardiographic estimates of pulmonary pressure , and allowed for phlebotomy to reduce hepatic iron . The mean annual hospitalization rate was 3.23 ( 95 % CI , 1.83 - 4.63 ) the year before , 0.63 ( 95 % CI , 0.26 - 1.01 ) the first year after , 0.19 ( 95 % CI , 0 - 0.45 ) the second year after , and 0.11 ( 95 % CI , 0.04 - 0.19 ) the third year after transplant . For patients taking long-term narcotics , the mean use per week was 639 mg ( 95 % CI , 220 - 1058 ) of intravenous morphine-equivalent dose the week of their transplants and 140 mg ( 95 % CI , 56 - 225 ) 6 months after transplant . There were 38 serious adverse events : pain and related management , infections , abdominal events , and sirolimus related toxic effects . CONCLUSIONS AND RELEVANCE Among 30 patients with sickle cell phenotype with or without thalassemia who underwent nonmyeloablative allogeneic HSCT , the rate of stable mixed-donor chimerism was high and allowed for complete replacement with circulating donor red blood cells among engrafted participants . Further accrual and follow-up are required to assess longer-term clinical outcomes , adverse events , and transplant tolerance . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00061568 Prior studies of asthma in children with sickle cell disease ( SCD ) were based on reports of a doctor‐diagnosis of asthma with limited description of asthma features . Doctor‐diagnoses of asthma may represent asthma or wheezing unrelated to asthma . Objectives of this study were to determine if asthma characteristics are present in adults with a doctor‐diagnosis of asthma and /or wheezing , and to examine the relationship between doctor‐diagnosis of asthma , wheezing and SCD morbidity . This was an observational cohort study of 114 adults with SCD who completed respiratory symptom question naires and had serum IgE measurements . A subset of 79 participants completed pulmonary function testing . Survival analysis was based on a mean prospect i ve follow‐up of 28 months and data were censored at the time of death or loss to follow‐up . Adults reporting a doctor‐diagnosis of asthma ( N = 34 ) were more likely to have features of asthma including wheeze , eczema , family history of asthma , and an elevated IgE level ( all P < 0.05 ) . However , there was no difference in pain or ACS rate , lung function , or risk of death between adults with and without a doctor‐diagnosis of asthma . In contrast , adults who reported recurrent , severe episodes of wheezing ( N = 34 ) , regardless of asthma , had twice the rates of pain and ACS , decreased lung function and increased risk of death compared with adults without recurrent , severe wheezing . Asthma features were not associated with recurrent , severe wheezing . Our data suggest that wheezing in SCD may occur independently of asthma and is a marker of disease severity . Am . J. Hematol . 2011 . © 2011 Wiley‐Liss , Pain and acute chest syndrome ( ACS ) episodes are 2 of the most common causes of hospitalization in children with sickle cell anemia ( SCA ) . However , very few potentially modifiable risk factors for either condition have been identified . In this prospect i ve infant cohort study , we tested the hypothesis that asthma is associated with an increased incidence rate of pain and ACS episodes . An infant cohort was composed of 291 African American children with hemoglobin SS enrolled in the Cooperative Study for Sickle Cell Disease before age 6 months and followed beyond age 5 years . Asthma was defined by a physician diagnosis , an acute asthma event , or use of prescription asthma medications . The incidence rates of ACS and painful episodes were compared for children with and without asthma . A clinical diagnosis of asthma was made in 17 % of the cohort . Asthma was associated with more frequent ACS episodes ( 0.39 vs 0.20 events per patient year , P < .001 ) and painful episodes ( 1.39 vs 0.47 events per patient year , P < .001 ) . In conclusion , in children with SCA , asthma is associated with an increased incidence of sickle cell disease-related morbidity , including ACS and painful episodes An analysis of a prospect i ve cohort of individuals with sickle cell anemia ( SCA ) , enrolled from birth through adulthood , was conducted to determine if asthma is a risk factor for death in SCA . All-cause mortality was determined for participants after adjusting for known risk factors for death in SCA . The study included 1,963 individuals who were followed for 18,495 patient-years . After controlling for established risk factors , individuals with SCA and asthma had a more than two-fold higher risk of mortality ( hazard ratio 2.36 , 95 % CI 1.21 to 4.62 , p=0.01 ) . To summarize , asthma is a risk factor for death in SCA \n Output:\n " }, { "from": "agent", "value": "The presence of asthma or asthma symptom(recurrentwheezing ) , significantly increases the risk ofSCD-relatedmorbidity4 and mortality.5 - 7However , the guideline doesnotprovide anyapproach to screen and treat asthma orasthma-like symptoms ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background There is a growing dem and for services whereby individuals receive assistance from care workers for personal care within the home . This has led to the development of re-ablement or restorative homecare services that provide time-limited input aim ed at reducing dependency in personal activities of daily living , and preventing or delaying the need for further homecare support . However , little is currently known about how such interventions are configured , or how they may affect individuals ’ ability to carry out personal care independently . Methods / Design We will seek to identify studies that compare an intervention design ed to reduce dependency in personal activities of daily living with routine input or usual care as the control . We will include r and omised controlled trials , nonr and omised controlled trials , and controlled before and after studies . We will also include interrupted time series studies .We shall search electronic data bases in addition to search ing for ongoing and unpublished studies , and where appropriate will contact key authors . Two review ers will independently screen articles for inclusion ; will assess risk of bias using quality assessment tools ; and will carry out data extraction using pre-prepared forms . Any disagreements , at any stage , will be resolved by discussion and the involvement of a third review er if needed . We will produce a narrative summary of the results . A meta- analysis will be conducted if sufficient data are available of appropriate quality and comparability . Discussion The findings from this review will inform future practice within homecare re-ablement services ; will inform policy decisions about the structure , organisation and content of such services ; and will identify areas where further research is warranted . Systematic review registration This review protocol has been registered on the PROSPERO data base ( CRD42013004163 ) OBJECTIVES To test the efficacy of a multicomponent intervention to reduce functional difficulties , fear of falling , and home hazards and enhance self-efficacy and adaptive coping in older adults with chronic conditions . DESIGN A prospect i ve , two-group , r and omized trial . Participants were r and omized to a treatment group or no-treatment group . SETTING Urban community-living older people . PARTICIPANTS Three hundred nineteen community-living adults aged 70 and older who reported difficulty with one or more activities of daily living . INTERVENTION Occupational and physical therapy sessions involving home modifications and training in their use ; instruction in strategies of problem-solving , energy conservation , safe performance , and fall recovery techniques ; and balance and muscle strength training . MEASUREMENTS Outcome measures included self-rated functional difficulties with ambulation , instrumental activities of daily living , activities of daily living , fear of falling , confidence performing daily tasks , and use of adaptive strategies . Observations of home hazards were also conducted . RESULTS At 6 months , intervention participants had less difficulty than controls with instrumental activities of daily living ( P=.04 , 95 % confidence interval (CI)=-0.28 - 0.00 ) and activities of daily living ( P=.03 , 95 % CI=-0.24 to -0.01 ) , with largest reductions in bathing ( P=.02 , 95 % CI=-0.52 to -0.06 ) and toileting ( P=.049 , 95 % CI=-0.35 - 0.00 ) . They also had greater self-efficacy ( P=.03 , 95 % CI=0.02 - 0.27 ) , less fear of falling ( P=.001 , 95 % CI=0.26 - 0.96 ) , fewer home hazards ( P=.05 , 95 % CI=-3.06 - 0.00 ) , and greater use of adaptive strategies ( P=.009 , 95 % CI=0.03 - 0.22 ) . Benefits were sustained at 12 months for most outcomes . CONCLUSION A multicomponent intervention targeting modifiable environmental and behavioral factors results in life quality improvements in community-dwelling older people who had functional difficulties , with most benefits retained over a year INTRODUCTION Health services delivered in an older person 's home are often implemented at a critical juncture in an individual 's functional status . Although homecare has potential to improve this situation , it often focuses on treating disease and ' taking care ' of the patient rather than promoting independence . The aim of restorative homecare is to change the philosophy from one where delivery of care may create dependency to provision of care which maximises independence , self-esteem , self-image and quality of life , and reduces the care required . AIMS To assess impact of a design ated goal facilitation tool on health-related quality of life ( HRQoL ) , social support and physical function among community-dwelling older people referred for homecare . METHODS A total of 205 participants [ mean age 79.1 years , 71.3 % female ( intervention group ) and 76.9 years with 60.8 % female ( control group ) ] were cluster r and omised to an intervention or control assessor . The intervention arm involved participants completing a goal facilitation tool with assessors . This established rehabilitation aims . Control participants received a st and ard needs assessment . Clients from both groups were then referred to a homecare organisation for service delivery . RESULTS There was greater change over time in HRQoL [ measured by Short Form 36 Survey ( SF-36 ) ] in the intervention group ( P = 0.0001 ) . There was a marked variation across homecare providers in types of services provided ( P < 0.001 ) . Identification of a goal did not predict completion of a formalised review of participants ' needs by the homecare organisation . CONCLUSIONS Use of a goal facilitation tool in assessment of an older person 's needs on referral for homecare leads to significant improvements in HRQoL. This may be through a higher proportion of individualised activities tailored to a successful identification of the person 's goals . The findings contribute to greater underst and ing of factors necessary to implement improvements in homecare services for older people OBJECTIVE To compare a specialized interprofessional team approach to community-based stroke rehabilitation with usual home care for stroke survivors using home care services . METHODS R and omized controlled trial of 101 community-living stroke survivors ( < 18 months post-stroke ) using home care services . Subjects were r and omized to intervention ( n=52 ) or control ( n=49 ) groups . The intervention was a 12-month specialized , evidence -based rehabilitation strategy involving an interprofessional team . The primary outcome was change in health-related quality of life and functioning ( SF-36 ) from baseline to 12 months . Secondary outcomes were number of strokes during the 12-month follow-up , and changes in community reintegration ( RNLI ) , perceived social support ( PRQ85-Part 2 ) , anxiety and depressive symptoms ( Kessler-10 ) , cognitive function ( SPMSQ ) , and costs of use of health services from baseline to 12 months . RESULTS A total of 82 subjects completed the 12-month follow-up . Compared with the usual care group , stroke survivors in the intervention group showed clinical ly important ( although not statistically significant ) greater improvements from baseline in mean SF-36 physical functioning score ( 5.87 , 95 % CI -3.98 to 15.7 ; p=0.24 ) and social functioning score ( 9.03 , CI-7.50 to 25.6 ; p=0.28 ) . The groups did not differ for any of the secondary effectiveness outcomes . There was a higher total per-person costs of use of health services in the intervention group compared to usual home care although the difference was not statistically significant ( p=0.76 ) . CONCLUSIONS A 12-month specialized , interprofessional team is a feasible and acceptable approach to community-based stroke rehabilitation that produced greater improvements in quality of life compared to usual home care . Clinical trials.gov identifier : NCT00463229 The Home Independence Program ( HIP ) is a short-term restorative programme targeted at older home-care clients , who do not have a diagnosis of dementia , when they are first referred for assistance or when they are referred for additional services because their needs have increased . This study compared the outcomes for individuals who participated in HIP with those of individuals who received ' usual ' home-care services . The study was conducted in metropolitan Perth , Western Australia , between 2001 and 2003 , when HIP was being trialled as a service in just one region . One hundred clients were recruited into each group and were visited at home on three occasions -- service start and at 3 months and 1 year . St and ardised outcome measures were used to measure functional dependency , morale , confidence in performing everyday activities without falling and functional mobility . Service outcomes were also examined at 3 months and 1 year . The HIP group showed improvements on all personal outcome measures compared with the control group . These improvements were , except for the morale scale , significantly associated with group assignment even when baseline differences between the groups were adjusted for . As regards service outcomes , the odds of the individuals who received HIP still requiring services was 0.07 ( 95 % CI = 0.03 - 0.15 , P < 0.001 ) times those for the individuals in the control group at 3 months and 0.14 times at 12 months ( 95 % CI = 0.07 - 0.29 , P < 0.001 ) . The results of this study supported the hypothesis that older individuals referred for home care who participated in a programme to promote their independence had better individual and service outcomes than individuals who received usual home care PURPOSE To evaluate the clinical outcomes of a nurse care coordination program for people receiving services from a state-funded home and community-based waiver program called Missouri Care Options ( MCO ) . DESIGN A quasi-experimental design was used to compare 55 MCO clients who received nurse care coordination ( NCC ) and 30 clients who received MCO services but no nurse care coordination . METHODS Nurse care coordination consists of the assignment of a registered nurse who provides home care services for both the MCO program and Medicare home health services . Two st and ardized data sets , the Minimum Data Set ( MDS ) for resident care and planning and the Outcome Assessment Instrument and Data Set ( OASIS ) were collected at baseline , 6 months , and 12 months on both groups . Cognition was measured with the MDS Cognitive Performance Scale ( CPS ) , activities of daily living ( ADL ) as the sum of five MDS ADL items , depression with the MDS-Depression Rating Scale , and incontinence and pressure ulcers with specific MDS items . Three OASIS items were used to measure pain , dyspnea , and medication management . The Cochran-Mantel-Haenszel ( CMH ) method was used to test the association between the NCC intervention and clinical outcomes . FINDINGS At 12 months the NCC group scored significantly better statistically in the clinical outcomes of pain , dyspnea , and ADLs . No significant differences between groups were found in eight clinical outcome measures at 6 months . CONCLUSIONS Use of nurse care coordination for acute and chronic home care warrants further evaluation as a treatment approach for chronically ill older adults A r and omised controlled trial was conducted to test the effectiveness of the Home Independence Program ( HIP ) , a restorative home-care programme for older adults , in reducing the need for ongoing services . Between June 2005 and August 2007 , 750 older adults referred to a home-care service for assistance with their personal care participated in the study and received HIP or ' usual ' home-care services . Service outcomes were compared at 3 and 12 months . Subgroups of 150 from each group were also compared on functional and quality of life measures . Data were analysed by ' intention-to-treat ' and ' as-treated ' . The intention-to-treat analysis showed at 3 and 12 months that the HIP group was significantly less likely to need ongoing personal care [ Odds ratio ( OR ) = 0.18 , 95 % CI = 0.13 - 0.26 , P < 0.001 ; OR = 0.22 , 95 % CI = 0.15 - 0.32 , P < 0.001 ] . Both subgroups showed improvements on the individual outcome measures over time with the only significant differences being found at 12 months for Instrumental Activities of Daily Living ( IADL ) in the as-treated analysis . Contamination of the control group by an increased emphasis on independence across the home-care agency involved , together with other method ological problems encountered , is thought to account for the few differences between groups in individual outcomes . Despite no difference between the groups over time in their overall ADL scores , a significantly smaller proportion of the HIP group required assistance with bathing/showering , the most common reason for referral , at 3 and 12 months . The results support earlier findings that participating in a short-term restorative programme appears to reduce the need for ongoing home care . The implementation of such programmes more broadly throughout Australia could substantially offset the projected increase in dem and for home care associated with the five-fold projected increase in numbers of the oldest old expected over the next 40 years Due to the ageing population , there is an increased dem and for home care services . Restorative care is one approach to improving home care services , although there is little evidence to support its use in the community setting . The objective of this trial was to evaluate the impact of a restorative home care service for community-dwelling older people . The study was a cluster r and omised controlled trial undertaken at a home care agency in New Zeal and . The study period was from December 2005 to May 2007 . Older people were interviewed face-to-face at baseline , four and 7 months . A total of 186 older people who received assistance from a home care agency participated in the study , 93 received restorative home care and 93 older people received usual home care . The primary outcome measure was change in health-related quality of life ( measured by the Short Form 36 [ SF36 ] Health Survey ) . Secondary outcomes were the physical , mental , and social well-being of older people ( Nottingham Extended Activities of Daily Living , Timed Up and Go , Mastery scale , Duke Social Support Index ) . Findings revealed that compared with usual care , the intervention demonstrated a statistically significant benefit in health-related quality of life \n Output:\n " }, { "from": "agent", "value": "Occupational therapy : there was insufficient evidence to determine whether involvement of qualified occupational therapists influenced effectiveness .\nConclusion : There is limited evidence that interventions targeted at personal ADL can reduce homecare service users ’ dependency with activities , the content of evaluated interventions varies greatly" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE This study 's purpose was to test silver diammine fluoride ( SDF ) in arresting incipient occlusal caries in erupting permanent first molars and to compare it with other approaches . METHODS Sixty-six first erupting permanent molars were r and omly divided into 3 groups : cross tooth-brushing technique ( CTT ) , application of SDF , and glass ionomer fissure sealant ( GIC ) . The clinical procedures were conducted by the same dentist . Teeth were assessed clinical ly by 1 blinded examiner using visual inspection at baseline and after 3 , 6 , 12 , 18 , and 30 months and radiographically at 6- , 12- , and 30-month follow-up evaluations . The Kruskall-Wallis test was used to compare noninvasive treatments , and the Friedman test was performed to evaluate differences for each group during different follow-up periods . RESULTS A reduced number of active caries lesions was noted in all groups . After 3 and 6 months , SDF showed a significantly greater capacity for arresting caries lesions than CTT and GIC . At 18- and 30-month evaluations , no differences were observed among the 3 groups . All groups showed differences between baseline and all follow-up re-examinations . CONCLUSIONS All the tested techniques are equally efficient in controlling initial occlusal caries in erupting permanent first molars after 30-months of follow-up OBJECTIVE To compare the effectiveness of annual topical application of silver diamine fluoride ( SDF ) solution , semi-annual topical application of SDF solution , and annual application of a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth . METHODS A total of 212 children , aged 3 - 4 years , were r and omly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth : Gp1-annual application of SDF , Gp2-semi-annual application of SDF , and Gp3-annual application of glass ionomer . Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested . RESULTS After 24 months , 181 ( 85 % ) children remained in the study . The caries arrest rates were 79 % , 91 % and 82 % for Gp1 , Gp2 and Gp3 , respectively ( p=0.007 ) . In the logistic regression model using GEE to adjust for clustering effect , higher caries arrest rates were found in lesions treated in Gp2 ( OR=2.98 , p=0.007 ) , those in anterior teeth ( OR=5.55 , p<0.001 ) , and those in buccal/lingual smooth surfaces ( OR=15.6 , p=0.004 ) . CONCLUSION Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries . Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application . CLINICAL SIGNIFICANCE Arrest of active dentine caries in primary teeth by topical application of SDF solution can be enhanced by increasing the frequency of application from annually to every 6 months , whereas annual paint-on of a flowable glass ionomer can also arrest active dentine caries and may provide a more aesthetic outcome Background Occlusal surfaces of erupting and newly erupted permanent molars are particularly susceptible to caries . The objective of the study was to assess and compare the effect of a single application of 38 % SDF with ART sealants and no treatment in preventing dentinal ( D3 ) caries lesions on occlusal surfaces of permanent first molars of school children who participated in a daily school-based toothbrushing program with fluoride toothpaste . Methods The prospect i ve community clinical trial in the Philippines was conducted over a period of 18 months and included 704 six- to eight-year-old school children in eight public elementary schools with a daily school-based fluoride toothpaste brushing program . Children were r and omly assigned for SDF application or ART sealant treatment . Children from two of the eight schools did not receive SDF or ART sealant treatment and served as controls . SDF or ART sealant treatment was applied on sound occlusal surfaces of permanent first molars . Surfaces that were originally defined as sound at baseline but which changed to dentinal ( D3 ) caries lesions were defined as surfaces with new caries ( caries increment ) . Non-compliance to the daily toothbrushing program in three schools offered the opportunity to analyze the caries preventive effect of SDF and sealants separately in fluoride toothpaste brushing and in non-toothbrushing children . Results In the brushing group , caries increment in the SDF treatment group was comparable with the non-treatment group but caries increment in the sealant group was lower than in the non-treatment group with a statistically significant lower hazard ratio of 0.12 ( 0.02 - 0.61 ) . In the non-brushing group , caries increment in the SDF treatment group and the sealant group was lower than the non-treatment group but the hazard ratio was only statistically significant for the sealant group ( HR 0.33 ; 0.20 - 0.54 ) . Caries increment was lower in toothbrushing children than in non-toothbrushing children . Hazard ratios reached statistical significance for the non-treated children ( HR 0.43 ; 0.21 - 0.87 ) and the sealant-treated children ( HR 0.15 ; 0.03 - 0.072 ) . Conclusions A one-time application of 38 % SDF on the occlusal surfaces of permanent first molars of six- to eight-year-old children is not an effective method to prevent dentinal ( D3 ) caries lesions . ART sealants significantly reduced the onset of caries over a period of 18 months . Trial registration numberGerman Clinical Trial Register Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials OBJECTIVES This ex vivo study compared the physico-chemical structural differences between primary carious teeth biannually treated with silver diamine fluoride ( SDF ) and carious teeth without such treatment . METHOD Twelve carious primary upper- central incisors were collected from 6-year-old children . Six teeth had arrested caries after 24-month biannual SDF applications and 6 had active caries when there was no topical fluoride treatment . The mineral density , elemental contents , surface morphology , and crystal characteristics were assessed by micro-computed tomography ( micro-CT ) , energy-dispersive X-ray spectrometry ( EDX ) , scanning electron microscopy ( SEM ) , and transmission electron microscopy ( TEM ) . RESULTS Micro-CT examination revealed a superficial opaque b and approximately 150μm on the arrested cavitated dentinal lesion . This b and was limited in the active carious lesion . EDX examination detected a higher intensity of calcium and phosphate of 150μm in the surface zone than in the inner zone , but this zone was restricted in the active cavitated dentinal lesion . SEM examination indicated that the collagens were protected from being exposed in the arrested cavitated dentinal lesion , but were exposed in the active cavitated dentinal lesion . TEM examination suggested that remineralised hydroxyapatites were well aligned in the arrested cavitated dentinal lesion , while those in the active cavitated dentinal lesion indicated a r and om apatite arrangement . CONCLUSIONS A highly remineralised zone rich in calcium and phosphate was found on the arrested cavitated dentinal lesion of primary teeth with an SDF application . The collagens were protected from being exposed in the arrested cavitated dentinal lesion . CLINICAL SIGNIFICANCE Clinical SDF application positively influences dentine remineralisation Arresting Caries Treatment ( ACT ) has been proposed to manage untreated dental caries in children . This prospect i ve r and omized clinical trial investigated the caries-arresting effectiveness of a single spot application of : ( 1 ) 38 % silver diamine fluoride ( SDF ) with tannic acid as a reducing agent ; ( 2 ) 38 % SDF alone ; ( 3 ) 12 % SDF alone ; and ( 4 ) no SDF application in primary teeth of 976 Nepalese schoolchildren . The a priori null hypothesis was that the different treatments have no effect in arresting active cavitated caries . Only the single application of 38 % SDF with or without tannic acid was effective in arresting caries after 6 months ( 4.5 and 4.2 mean number of arrested surfaces ; p < 0.001 ) , after 1 year ( 4.1 and 3.4 ; p < 0.001 ) , and after 2 years ( 2.2 and 2.1 ; p < 0.01 ) . Tannic acid conferred no additional benefit . ACT with 38 % SDF provides an alternative when restorative treatment for primary teeth is not an option Systematic evaluation is an integral part of the organisation and delivery of community oral health care programmes , ensuring the effectiveness of these community-based interventions . As for general health promotion programmes the common problems from effectiveness review s of oral health interventions relate to the quality and validity of programme evaluations . Problems identified mostly refer to the quality of outcome measures , short-term timescales to assess change , inadequate evaluation method ologies and inappropriate evaluation of programme implementation and processes . It remains a challenge to oral health professionals to integrate community oral health programmes into a wider health agenda . Public health research focusing on the development of evaluation method ologies has identified a variety of issues including the importance of using pluralistic evaluation approaches ( quantitative and /or qualitative ) , limitations of the r and omised controlled trial ( RCT ) design for evaluation of public health interventions , the need to match evaluation methods with the nature of intervention , development of outcome measures appropriate for the nature of intervention , importance of developing workforce capacity in evaluation techniques , and the need for development of partnerships between health practitioners and academics in conducting evaluations . In June 2003 , the WHO Oral Health Programme at Headquarters organised a two-day workshop to take forward the development and documentation of the evaluation of oral health promotion and oral disease prevention programmes . The aims of the workshop were to : ( 1 ) identify common problems and challenges in evaluating community-based oral health interventions ; ( 2 ) explore developments in the evaluation approaches in public health ; ( 3 ) share experiences in evaluating oral health intervention programmes implemented at national or community levels in developing and developed countries and ( 4 ) develop guidelines for quality evaluation of national and community oral health programmes . Twenty-two invitees from 15 countries attended in addition to WHO staff . The first day was devoted to presentations of oral health promotion and oral disease prevention programmes from around the world . During the second day , WHO staff at Headquarters in Geneva discussed aspects of evaluation of public health programmes . Two working groups were formed to discuss agreed topics , and the reports from their deliberations , together with the general discussion , result ed in the presentation of emerging key issues and recommendations . In summary , it was agreed that evaluation of oral health promotion and disease prevention programmes should integrate , whenever possible , with general health programmes . While the design and advantages of RCTs in clinical evaluations are well documented , the relevance of this design in evaluation of community oral disease preventive programmes and oral health promotion programmes are much less clearly defined . Subsequently , the conduct of such programmes may be inappropriately evaluated in systematic review s. There is a need for more research into appropriate immediate , interim and ultimate outcome measures , as well as process evaluation , an assessment that is poorly understood and practised less often than outcome evaluation . Guidance on potential design , conduct , and especially the evaluation , of community oral disease prevention programmes and oral health promotion programmes should be developed and up date d regularly . WHO Collaborating Centres could have a role in promoting good practice , training and collaboration between teams throughout the world . Centres undertaking systematic review s should consider the guidelines given in the proposed \n Output:\n " }, { "from": "agent", "value": "The literature indicates that SDF is a preventive treatment for dental caries in community setting s. At concentrations of 30 % and 38 % , SDF shows potential as an alternative treatment for caries arrest in the primary dentition and permanent first molars ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aim To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease ( IHD ) . Methods and results In this single-blind , parallel , two-arm , r and omized controlled trial adults ( n = 171 ) with IHD were r and omized to receive a mobile phone delivered intervention ( HEART ; n = 85 ) plus usual care , or usual care alone ( n = 86 ) . Adult participants aged 18 years or more , with a diagnosis of IHD , were clinical ly stable as out patients , able to perform exercise , able to underst and and write English , and had access to the Internet . The HEART ( Heart Exercise And Remote Technologies ) intervention involved a personalized , automated package of text messages and a secure website with video messages aim ed at increasing exercise behaviour , delivered over 24 weeks . All participants were able to access usual community-based cardiac rehabilitation , which involves encouragement of physical activity and an offer to join a local cardiac support club . All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake ( PVO2 ; primary outcome ) , self-reported physical activity , health-related quality of life , self-efficacy and motivation ( secondary outcomes ) . Results showed no differences in PVO2 between the two groups ( difference −0.21 ml kg−1 min−1 , 95 % CI : −1.1 , 0.7 ; p = 0.65 ) at 24 weeks . However significant treatment effects were observed for selected secondary outcomes , including leisure time physical activity ( difference 110.2 min/week , 95 % CI : −0.8 , 221.3 ; p = 0.05 ) and walking ( difference 151.4 min/week , 95 % CI : 27.6 , 275.2 ; p = 0.02 ) . There were also significant improvements in self-efficacy to be active ( difference 6.2 % , 95 % CI : 0.2 , 12.2 ; p = 0.04 ) and the general health domain of the SF36 ( difference 2.1 , 95 % CI : 0.1 , 4.1 ; p = 0.03 ) at 24 weeks . The HEART programme was considered likely to be cost-effective for leisure time activity and walking . Conclusions A mobile phone intervention was not effective at increasing exercise capacity over and above usual care . The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services BACKGROUND Current guidelines broadly recommend comprehensive cardiac rehabilitation ( CR ) , although evidence for this is still limited . It is not known whether evidence from before 1995 is still valid . STUDY DESIGN The DANish Cardiac ReHABilitation ( DANREHAB ) trial was design ed as a central ly r and omized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure , ischemic heart disease , or high risk for ischemic heart disease . A combined primary outcome measure included total mortality , myocardial infa rct ion , or readmissions due to heart disease based on linkage to public registries . The CR was an individually tailored , multidisciplinary program ( 6 weeks of intensive CR and 12 months of follow-up ) including patient education , exercise training , dietary counseling , smoking cessation , psychosocial support , risk factor management , and clinical assessment . STUDY POPULATION Of 5060 discharged patients , 1614 ( 32 % ) were eligible for the trial and 770 patients were r and omized ( 47 % of those eligible ) . Participants were younger ( P < .001 ) and had less comorbidity than non participants ( P < .03 ) . CONCLUSION Our trial shows that a large-scale , central ly r and omized clinical trial on comprehensive CR can be conducted among a broadly defined patient group , but reaching the stipulated number of 1800 patients was difficult . Although the study included relatively many women and older people , elderly patients and patients with high comorbidity were underrepresented , which may influence the external validity Background : The CardioFit internet-based expert system was design ed to promote physical activity in patients with coronary heart disease ( CHD ) who were not participating in cardiac rehabilitation . Design : This r and omized controlled trial compared CardioFit to usual care to assess its effects on physical activity following hospitalization for acute coronary syndromes . Methods : A total of 223 participants were recruited at the University of Ottawa Heart Institute or London Health Sciences Centre and r and omly assigned to either CardioFit ( n = 115 ) or usual care ( n = 108 ) . The CardioFit group received a personally tailored physical-activity plan upon discharge from the hospital and access to a secure website for activity planning and tracking . They completed five online tutorials over a 6-month period and were in email contact with an exercise specialist . Usual care consisted of physical activity guidance from an attending cardiologist . Physical activity was measured by pedometer and self-reported over a 7-day period , 6 and 12 months after r and omization . Results : The CardioFit internet-based physical activity expert system significantly increased objective ly measured ( p = 0.023 ) and self-reported physical activity ( p = 0.047 ) compared to usual care . Emotional ( p = 0.038 ) and physical ( p = 0.031 ) dimensions of heart disease health-related quality of life were also higher with CardioFit compared to usual care . Conclusions : Patients with CHD using an internet-based activity prescription with online coaching were more physically active at follow up than those receiving usual care . Use of the CardioFit program could extend the reach of rehabilitation and secondary -prevention services Aim : To examine the effectiveness of a four-week home-based self-management rehabilitation programme on health-related quality of life , anxiety and depression levels , cardiac risks and unplanned visits to the health services among community-dwelling patients with myocardial infa rct ion . Methods : A r and omised controlled trial with repeated measurements was used . A convenience sample of 128 patients with myocardial infa rct ion was recruited from outpatient cardiology clinics at a tertiary hospital in Singapore . Participants were r and omly assigned to the intervention group or control group . The outcomes were measured using Short Form 12-item Health Survey Version 2 , Myocardial Infa rct ion Dimensional Assessment Scale , and Hospital Anxiety and Depression Scale . The cardiac physiological risk parameters and number of unplanned health service use were also assessed . Data were collected at baseline , and at four weeks and 16 weeks from the baseline . Results : Over the 16 weeks , the two groups reported significant differences in physical activity ( F = 4.23 , p = 0.02 ) , dependency ( F = 5.16 , p = 0.01 ) , concerns over medication ( F = 3.47 , p = 0.04 ) on MIDAS , anxiety level ( F = 3.41 , p = 0.04 ) and body mass index ( F = 3.12 , p = 0.04 ) . A significant difference was also found in unplanned cardiac-related emergency room visits ( χ2 = 6.64 , p = 0.036 ) and medical consultation ( χ2 = 9.67 , p = 0.046 ) at the 16-week study point . Conclusion : The study may provide a useful tool to help health care professionals to meet the cardiac rehabilitative care needs of community-dwelling patients with myocardial infa rct ion in Singapore Background Angina affects more than 50 million people worldwide . Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population . An Internet-based version could offer a feasible alternative . Objective Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina . Methods We conducted a r and omized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group . Intervention group participants were offered a 6-week Web-based rehabilitation program ( “ ActivateYourHeart ” ) . The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) . The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking . Performance against goals was review ed throughout the program and goals were then reset/modified . Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room . Participants in the control group continued with GP treatment as usual , which consisted of being placed on a CHD register and attending an annual review . Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessment s. The primary outcome measure was change in daily steps at 6 weeks , measured using an accelerometer . Secondary outcome measures were energy expenditure ( EE ) , duration of sedentary activity ( DSA ) , duration of moderate activity ( DMA ) , weight , diastolic/systolic blood pressure , and body fat percentage . Self-assessed question naire outcomes included fat/fiber intake , anxiety/depression , self-efficacy , and quality of life ( QOL ) . Results A total of 94 participants were recruited and r and omized to the intervention ( n=48 ) or the usual care ( n=46 ) group ; 84 and 73 participants completed the 6-week and 6-month follow-ups , respectively . The mean number of log-ins to the program was 18.68 ( SD 13.13 , range 1 - 51 ) , an average of 3 log-ins per week per participant . Change in daily steps walked at the 6-week follow-up was + 497 ( SD 2171 ) in the intervention group and –861 ( SD 2534 ) in the control group ( 95 % CI 263 - 2451 , P=.02 ) . Significant intervention effects were observed at the 6-week follow-up in EE ( + 43.94 kcal , 95 % CI 43.93 - 309.98 , P=.01 ) , DSA ( –7.79 minutes , 95 % CI –55.01 to –7.01 , P=.01 ) , DMA ( + 6.31 minutes , 95 % CI 6.01 - 51.20 , P=.01 ) , weight ( –0.56 kg , 95 % CI –1.78 to –0.15 , P=.02 ) , self-efficacy ( 95 % CI 0.30 - 4.79 , P=.03 ) , emotional QOL score ( 95 % CI 0.01 - 0.54 , P=.04 ) , and angina frequency ( 95 % CI 8.57 - 35.05 , P=.002 ) . Significant benefits in angina frequency ( 95 % CI 1.89 - 29.41 , P=.02 ) and social QOL score ( 95 % CI 0.05 - 0.54 , P=.02 ) were also observed at the 6-month follow-up . Conclusions An Internet-based secondary prevention intervention could be offered to those with angina . A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 90110503 ; http://www.controlled-trials.com/IS RCT N90110503/IS RCT N90110503 ( Archived by WebCite at http://www.webcitation.org/6RYVOQFKM ) Introduction Exercise-based cardiac rehabilitation ( CR ) independently alters the clinical course of cardiovascular diseases result ing in a significant reduction in all-cause and cardiac mortality . However , only 15%–30 % of all eligible patients participate in a phase 2 ambulatory programme . The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor . Newer care models , involving telerehabilitation programmes that are delivered remotely , show considerable promise for increasing adherence . In this view , the PATHway ( Physical Activity Towards Health ) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy . Methods and analysis In a multicentre r and omised controlled pilot trial , 120 participants ( m/f , age 40–80 years ) completing a phase 2 ambulatory CR programme will be r and omised on a 1:1 basis to PATHway or usual care . PATHway involves a comprehensive , internet-enabled , sensor-based home CR platform and provides individualised heart rate monitored exercise programmes ( exerclasses and exergames ) as the basis on which to provide a personalised lifestyle intervention programme . The control group will receive usual care . Study outcomes will be assessed at baseline , 3 months and 6 months after completion of phase 2 of the CR programme . The primary outcome is the change in active energy expenditure . Secondary outcomes include cardiopulmonary endurance capacity , muscle strength , body composition , cardiovascular risk factors , peripheral endothelial vascular function , patient satisfaction , health-related quality of life ( HRQoL ) , well-being , mediators of behaviour change and safety . HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation . Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki . This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site . Results will be dis \n Output:\n " }, { "from": "agent", "value": "Conclusion Overall , there is moderate evidence of an increase in PA with CR participation compared with control .\nHigh- quality trials are required , with robust PA measurement and data analysis methods , to assess if CR definitely leads to important improvements in PA" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : The reclassification of prescription only medicines to pharmacy and general sales list medicines ( also known as non-prescription medicines ) provides the public with greater access to medicines that they can purchase for self-care . There is evidence that non-prescription medicines may be associated with inappropriate supply . This study investigated factors predicting evidence -based ( guideline compliant ) supply or non-supply of non-prescription medicines . Method : Secondary analysis of results from a r and omised controlled trial of educational interventions to promote the evidence based supply of non-prescription medicines . Ten actors made simulated patient ( customer ) visits to 60 community pharmacies using seven scenarios reflecting different types of presentations . The dependent variable was appropriate ( guideline compliant ) supply of antifungal medication for treatment of vaginal c and idiasis . Results : No significant association was shown between guideline compliant behaviour and pharmacy type or location , or with the actor making the visit . The likelihood of guideline compliant outcome was significantly greater with symptom presentations than with condition or product presentations ( p<0.001 ) . The likelihood of a guideline compliant outcome increased ( a ) as more information was exchanged ( p<0.001 ) , ( b ) with the use of WWHAM ( a mnemonic frequently used by medicine counter assistants during consultations for non-prescription medicines ) ( p<0.001 ) ; ( c ) when specific WWHAM questions were used ( including “ description of symptoms ” ( p<0.001 ) and “ whether other medication was currently being used ” ( p<0.001 ) ; and ( d ) in consultations involving solely pharmacists compared with those involving only medicine counter assistants ( p = 0.017 ) . After adjustment for presentation type , a significant association persisted between appropriate outcome and consultations with WWHAM scores of 2 and ⩾3 , respectively . Conclusions : The nature and extent of information exchange between pharmacy staff and customers has a strong influence on the guideline compliant supply of non-prescription medicines . Future interventions to promote the safe and effective use of non-prescription medicines should address the apparent deficit in communication between pharmacy staff in general , and medicine counter assistants in particular , which may reflect both pharmacy staff skills and customer expectations Objective It is known that many people with insomnia choose to self medicate and present at community pharmacies , particularly in cases of acute insomnia . The objective of this study is to investigate how community pharmacists respond to complaints of acute insomnia from people who seek self treatment and determine the factors affecting this response . Setting Community pharmacies in New South Wales , Australia . Method A simulated patient study was conducted in 100 r and omly selected pharmacies located in Newcastle and Sydney , Australia . A st and ardized scenario of acute sleep onset insomnia and a scoring system was used in each pharmacy . Main outcome measures Main outcome measures included supply/non supply of an over the counter sleep aid to the simulated patient , and scores for pharmacists for skills in eliciting information prior to supply of medication ( Pre Supply Score ) , counseling about medication ( Supply Score ) , or about sleep ( Sleep Score ) . Results Of the 100 pharmacies , upon simulated patient presentation , 96 % supplied a product , the remaining 4 % referred to a physician . Non-pharmacological advice was provided in 42 % . Pharmacists scored highly on advice provided with supply of a medication ( Supply scores/4 , 3.1 ± 0.9 ) , but lower on skills in eliciting information prior to supply ( Pre-supply score/8 , 3.6 ± 1.9 ) and sleep related counselling ( Sleep Score/9 , 2.1 ± 1.7 ) . Lower estimated pharmacist age , being in a chain type pharmacy , and having a visible symbol of quality accreditation were found to significantly improve ( P < 0.05 the Sleep Score outcome . Lower estimated pharmacist age as also significantly associated with higher Supply Score ( P < 0.05 ) ; whilst both lower estimated age an visible quality assurance signage were associated with higher Pre-Supply scores ( P < 0.05 ) . Conclusion The results of this study suggest that many pharmacists are responding appropriately to complaints of sleeplessness in terms of eliciting insomnia type and counseling about medicines use . However more education for pharmacists would help to further promote good sleep health , and address behaviors including reliance on medicines taking that can progressively worsen insomnia Background : The importance of theory in underpinning interventions to promote effective professional practice is gaining recognition . The Medical Research Council framework for complex interventions has assisted in promoting awareness and adoption of theory into study design . Human error theory has previously been used by high risk industries but its relevance to healthcare setting s and patient safety requires further investigation . This study used this theory as a framework to explore non-prescription medicine supply from community pharmacies . The relevance to other healthcare setting s and behaviours is discussed . Method : A 25 % r and om sample was made of 364 observed consultations for non-prescription medicines . Each of the 91 consultations was assessed by two groups : a consensus group ( stage 1 ) to identify common problems with the consultation process , and an expert group ( stages 2 and 3 ) to apply human error theory to these consultations . Paired assessors ( most of whom were pharmacists ) categorised the perceived problems occurring in each consultation ( stage 1 ) . During stage 2 paired assessors from an expert group ( comprising patient safety experts , community pharmacists and psychologists ) considered whether each consultation was compliant with professional guidelines for the supply of pharmacy medicines . Each non-compliant consultation identified during stage 2 was then categorised as a slip/lapse , mistake , or violation using human error theory ( stage 3 ) . Results : During stage 1 most consultations ( n = 75 , 83 % ) were deemed deficient in information exchange . At stage 2 , paired assessors varied in attributing non-compliance to specific error types . Where agreement was achieved , the error type most often selected was “ violation ” ( n = 27 , 51.9 % , stage 3 ) . Consultations involving product requests were less likely to be guideline compliant than symptom presentations ( OR 0.30 , 95 % CI 0.10 to 0.95 , p = 0.05 ) . Conclusions : The large proportion of consultations classified as violations suggests that either pharmacy staff are unaware of professional guidelines and thus do not follow them ( therefore these acts would not be violations ) , or that they knowingly violate the guidelines due to reasons that need further research . The methods presented here could be used in other healthcare setting s to explore healthcare professional behaviour and to develop strategies to promote patient safety and effective professional practice Objective Using a self-reported work sampling methodology this study investigated how community pharmacists utilised their time , and quantified how much time pharmacists devoted to specific activities . Setting Community pharmacies ( n = 30 ) in the Greater Belfast area . Method A classification system was developed to define all activities ( professional , semi-professional , and non-professional tasks ) which could potentially be performed by a community pharmacist in the course of a normal working day ( from 9.00 to 6.00 pm ) . A r and om bleeper device was used which was programmed to bleep r and omly approximately 13 times per day ( over 12 days ) at which time the pharmacist recorded their precise activity ( using the classification system ) at that time on a proforma . All completed data sheets for each pharmacy were entered into an Excel ® spreadsheet , where the number of observations for each activity was expressed as a proportion of the total number of observations per day . Statistical analysis was carried out in SPSS , comparing these data to similar data which had been collected in 1998 . Results Pharmacists in this study were found to spend approximately 49 % of their time engaged in professional activities , 31 % in semi-professional activities and 20 % involved in non-professional activities which was similar to that reported in 1998 . Most time was spent on assembly and labelling of products , whilst staff training occupied the least amount of pharmacists ’ time . Pharmacists with a prescription volume of less than 1,499 per month spent significantly more time counselling patients on OTC medicines and responding to symptoms than those dispensing 1,500 items/month or more ( P = 0.027 ) . Pharmacists who employed a pre- registration student apportioned less time to the assembly and labelling of products compared to those without a student ( P = 0.08 ) . Pharmacists with three or more staff spent less time on coding and endorsing of prescriptions compared to those with less staff ( P = 0.086 ) . Conclusion Pharmacists in this study are spending more time checking prescriptions ( essential component of pharmaceutical care ) and are still managing to spend only 20 % of their time on non-professional activities . However , there had been relatively little change in the way in which pharmacists in this sample spent their time compared to a previous study Objective In a prospect i ve two-phase intervention study we evaluated a newly developed computerised pharmacy decision support system ( PDSS ) for the counselling of patients with allergic rhinitis and conjunctivitis . Method Community pharmacists were invited to counsel a virtual patient in a first interview . Immediately thereafter , we trained pharmacists to operate the PDSS , which they applied in a second patient interview immediately following the training . We assessed the completeness of m and atory questions asked as defined by national guidelines . Results Participating pharmacists ( n = 50 , 78 % female , mean age 34 [ IQR : 27–40 ] years , 8 [ 2–14.5 ] years of practical experience , 32 % specialised in community pharmacy ) asked considerably more m and atory questions to confirm appropriateness of self-medication with 7 ( 5.25–9 ; 78 % ) from 9 questions compared to 2 ( 1–3 ; 22 % ) without PDSS ( median ; P < 0.001 ) . In particular , using the PDSS more than doubled m and atory questions ( 9/12 , 6.25–10 ; 75 % vs. 4/12 , 3–5 ; 33 % ; P < 0.001 ) relevant for appropriate drug selection . Conclusion Pharmacists omitted many questions m and atory to assess whether self-medication is appropriate . Using the newly developed PDSS more than doubled the number of m and atory questions asked . The results suggest that the PDSS is ready for evaluation of its impact in real patients OBJECTIVE : To evaluate community pharmacists ' interpersonal skills , ability to make appropriate assessment of a patient 's drug-related problems , and ability to propose an appropriate therapeutic plan . DESIGN : A disguised shopper design was used . Four different case scenarios were design ed , with input from a five-member community/ primary care pharmacist advisory committee . Two different cases were assigned to each of two shoppers . One hundred and one pharmacies were shopped twice , totaling 202 shopping experiences . A three-member evaluation committee made up of clinical faculty members in ambulatory care and internal medicine assessed the appropriateness of the recommendations . SETTING : The study was conducted in 101 r and omly selected community pharmacies in the Pittsburgh area , including both chain and independent pharmacies . MAIN OUTCOME MEASURES : Main outcome measures included the quality of the pharmacists ' interpersonal skills , patient assessment skills , and recommendations . RESULTS : The majority of pharmacists demonstrated acceptable to good interpersonal skills . Overall , 31.7 % of the recommendations were appropriate , while 39.1 % were poor ( i.e. , recommendations that would likely worsen the patient 's condition or potentially harm the patient ) . In 33.2 % of the cases , recommendations were made without prior assessment of the patient 's problems . CONCLUSIONS : A lack of clinical knowledge and skills should be considered as a barrier that must be overcome if the provision of pharmaceutical care is to become a reality in community practice . OBJETIVO : Evaluar las destrezas interpersonales de farmacéuticos que ejercen en farmacias de comunidad y su habilidad para evaluar problemas relacionados con medicamentos y para proponer un plan terapéutico apropiado . DISEÑO : Un hombre y una mujer sin conocimiento de las ciencias de la salud recibieron adiestramiento que le permitiera representar situaciones clínicas preparadas por el investigador y completar una hoja de recolección de datos . Se asignó dos casos a cada persona . El investigador desarrolló cuatro casos que presentaban diferentes tipos de problemas relacionados con medicamentos . Un comité asesor compuesto por cinco farmacéuticos que ejercen en práctica ambulatoria revisó los casos . Cientouna farmacias recibieron dos visitas , para un total de 202 visitas o experiencias . Un comité evaluador compuesto por tres miembros de la facultad clínica asignada a medicina interna y atención ambulatoria evaluó las recomendaciones hechas por los farmacéuticos . ESCENARIO : Cientouna farmacias , independientes y de cadena , del área de Pittsburg se seleccionaron al azar . MEDICIÓN DE RESULT ADOS : Las medidas de result ados principales incluidas fueron : calidad de las destrezas interpersonales demostradas por los farmacéuticos , destrezas en la evaluación del paciente , y la adecuacidad de las recomendaciones hechas . RESULT ADOS : La mayoría de los farmacéuticos demostraron destrezas interpersonales de aceptables a buenas . El 31.7 % de las recomendaciones fueron apropiadas y el 39.1 % fueron pobres ( i.e. recomendaciones que podían empeorar la condición de salud o potencialmente causar daño al paciente ) . En el 33.2 % de los casos , las recomendaciones se hicieron sin analizar y evaluar los problemas de los \n Output:\n " }, { "from": "agent", "value": "The review showed that in terms of the contribution of community pharmacy staff in consultations for NPMs , non‐pharmacist staff dealt with a large proportion of the consultations and pharmacists were usually involved in the consultation through referral from non‐pharmacist staff member .\nCounseling was not consistently offered to everyone .\nWhere counseling was provided it was not always of sufficient quality .\nConsultations were performed much better when symptoms were presented compared to when people made a direct product request .\nPharmacists were reported to conduct better consultations than non‐pharmacist staff .\nThere was evidence to suggest that where counseling was appropriately provided this afforded the person a safe environment to utilize their NPMs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Tolfenamic acid is a fenamate which inhibits prostagl and in ( PG ) bio synthesis and may act as a PG antagonist as well . Caffeine and metoclopramide are used in combination with analgesics and ergotamine in the treatment of migraine attacks , but controlled clinical studies on fixed combinations with analgesics are rare . The effects of orally given tolfenamic acid ( 200 mg ) , caffeine ( 100 mg ) , metoclopramide ( 10 mg ) , tolfenamic acid + caffeine ( 200 mg + 100 mg ) , tolfenamic acid + metoclopramide ( 200 mg + 10 mg ) and placebo were studied in 49 migraine patients ( 3 men , 46 women ) in a double-blind r and omized cross-over study comprising 482 migraine attacks . The patients were allowed to take either one or two capsules of each preparation for an attack . Additional drugs were allowed after 3 h. Parameters characterizing the effects and side-effects of the drugs were registered . Tolfenamic acid and its combinations were found to be effective in the treatment of acute migraine , but caffeine and metoclopramide alone did not differ from placebo . Combination with metoclopramide was better than tolfenamic acid alone as judged by the smaller dose needed and the intensity of attack . Between tolfenamic acid alone and its caffeine combination there were no statistically significant differences Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Three hundred fifty out patients with postoperative pain after the surgical removal of impacted third molars were r and omly assigned , on a double-blind basis , to receive a single oral dose of aspirin 650 or 1000 mg , caffeine 65 mg , a combination of aspirin 650 mg with caffeine 65 mg , or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 6 hours after medicating . Estimates of summed pain intensity difference , peak pain intensity difference , total relief , peak relief , and hours of 50 % relief were derived from these subjective reports . All active treatments except caffeine were significantly superior to placebo . Pairwise comparisons indicated the aspirin-caffeine combination was statistically superior to aspirin 650 mg alone for hours of 50 % relief among patients who had severe baseline pain . Adverse effects were transitory and none were serious OBJECTIVE A phase II , r and omized , double-blind , crossover study was design ed to evaluate the efficacy of 100-mg diclofenac sodium softgel ( formulated using ProSorb technology ) with or without 100-mg caffeine versus placebo in migraineurs during migraine attacks . BACKGROUND Diclofenac has been demonstrated to be an effective migraine treatment in several placebo-controlled studies . A rapidly absorbed softgel of diclofenac has been shown to be effective in the rapid relief of acute pain , and may have advantages in migraine treatment . In addition , caffeine has consistently been shown to increase both the efficacy and speed of onset of concurrently administered analgesics . The ability of caffeine to both enhance and accelerate analgesic effects has been documented with a variety of different medications ( ie , aspirin , acetaminophen , ibuprofen , and ergotamine ) . METHODS The 3-period crossover study was design ed to compare diclofenac softgel 100 mg , diclofenac softgel 100 mg plus caffeine 100 mg , and placebo in the acute treatment of migraine . Subjects treated one moderate or severe attack with each study medication . The primary efficacy parameter was the percentage of subjects with headache relief at 60 minutes as defined by a reduction of headache severity from moderate or severe at baseline to absent or mild compared with placebo . Though the sample size estimate required that 72 subjects treat 3 separate attacks , 51 subjects treated 1 migraine attack , 44 treated 2 attacks , and 39 treated 3 attacks . Results .-In the placebo group , 6 ( 14 % ) of 43 subjects reported headache relief at 60 minutes versus 12 ( 27 % ) of 45 subjects in the diclofenac softgel group , and 19 ( 41 % ) of 46 subjects in the diclofenac softgel plus caffeine group . Differences were statistically significant for the diclofenac softgel plus caffeine group versus placebo ( odds ratio , 4.2 ; 95 % confidence interval , 1.3 to 13.7 ) . Rescue medication was used by 27 ( 63 % ) of 43 subjects treated with placebo , 15 ( 33 % ) of 45 subjects treated with diclofenac softgel , and 14 ( 30 % ) of 46 subjects treated with diclofenac softgel plus caffeine . This result is highly statistically significant ( chi22= 11.56 , P=.003 ) . Both the diclofenac plus caffeine ( P < .03 ) and diclofenac only ( P < .03 ) groups were significantly different from the placebo group in terms of the visual analog scale score at 60 minutes . CONCLUSIONS The major finding of the present study is that diclofenac softgel plus caffeine produces statistically significant benefits relative to placebo at 60 minutes . Diclofenac softgel alone did not differ significantly from placebo , perhaps due to limits in sample size . Nonsignificant trends support the analgesic adjuvant benefit of caffeine when added to diclofenac softgels A double-blind , cross-over trial was made of three analgesic preparations -- paracetamol , paracetamol with caffeine ( Finimal ) and aspirin in the relief of postoperative pain in 72 orthopedic in patients and in 144 ambulatory out patients suffering form common idiopathic headache . The combination of paracetamol and caffeine ( Finimal ) in this study shows the greatest pain relief in both groups of patients . This evaluation supports the results of BOOY3 demonstrating the superiority of the paracetamol-caffeine combination to paracetamol alone or aspirin To refine the assessment of over‐the‐counter analgesic agents in the treatment of muscle‐contraction headache , we design ed a single‐dose model with attention to specific method ologic features and two relevant assessment s — the percentage of subjects who achieve complete relief and the time until pain is no longer experienced . Subjects were r and omly assigned to receive a single dose of 1000 mg acetaminophen , 1000 mg aspirin with 64 mg caffeine , or placebo . Under double‐blind conditions , subjects rated headache pain intensity and relief over 4 hours and provided a Comparative Evaluation at the end of the trial . Both active agents were significantly distinguished from placebo on the time‐point analyses ( p < 0.05 ) and summary end point measurements ( sum of pain intensity difference [ SPID ] , total of pain relief , percentage of patients with complete relief , percentage of treatment failures , and the Comparative Evaluation ) , as well as causing a faster elimination of headache ( p < 0.05 ) . The aspirin‐caffeine combination was rated higher than acetaminophen on all summary measurements , particularly SPID ( p < 0.05 ) , with significantly more patients obtaining complete relief with aspirin‐caffeine ( p < 0.01 ) than with acetaminophen . We conclude that this headache pain model can be used to demonstrate the efficacy of over‐the‐counter analgesic agents and to assess their relative efficacy Objective .— To compare the superior efficacy of the fixed combination of acetylsalicylic acid , paracetamol , and caffeine over the single substances , which was observed in the r and omized , double‐blind phase of the clinical trial , with the efficacy of the respective usual nonprescription medication taken by the patients in the open‐label pre‐phase of the same study Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form & NA ; Caffeine is frequently added to mild analgesic preparations but its effect when used alone on pain has never been studied in humans . Using a double‐blind placebo‐controlled multiple crossover design , 53 patients with non‐migrainous headaches were given placebo , acetaminophen , 2 doses of caffeine and 2 combinations of caffeine with acetaminophen . Caffeine appeared to have independent analgesic effects that were equivalent to acetaminophen and were still significant when statistical adjustments were made for prior caffeine consumption and caffeine 's effects on mood & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data BACKGROUND Narcotics are used extens \n Output:\n " }, { "from": "agent", "value": "About 5 % to 10 % more participants achieve a good level of pain relief ( at least 50 % of the maximum over four to six hours ) with the addition of caffeine , giving a NNT of about 14 ( high quality evidence ) .Most comparisons individually demonstrated numerical superiority with caffeine , but not statistical superiority .\nThe addition of caffeine ( ≥ 100 mg ) to a st and ard dose of commonly used analgesics provides a small but important increase in the proportion of participants who experience a good level of pain relief" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Coronary endothelial function is impaired in hypertension ; however , the severity of this impairment varies among patients . We aim ed to identify the predictors of coronary endothelial dysfunction among clinical variables related to hypertension and atherosclerosis . Twenty-seven untreated , uncomplicated essential hypertensive patients and 10 age-matched healthy controls were studied prospect ively . Myocardial blood flow ( MBF ) was measured by using 15O-water positron emission tomography ( PET ) at rest and during a cold pressor test ( CPT ) . Coronary vascular resistance ( CVR ) during CPT was used as a marker of coronary endothelial function . Serum low density lipoprotein ( LDL ) cholesterol , high density lipoprotein ( HDL ) cholesterol , triglycerides , malondialdehyde-LDL , homeostasis model assessment , high-sensitivity C-reactive protein ( hs-CRP ) , and plasma interleukin-6 ( IL-6 ) and tumor necrosis factor (TNF)-α were also measured . CVR during CPT was significantly higher in hypertensive patients than in healthy controls ( 114±26 vs. 94±12 mmHg/[mL/g/min ] ; p<0.05 ) . By univariate analysis , CVR during CPT was correlated with LDL cholesterol ( r=0.38 , p<0.05 ) , IL-6 ( r=0.46 , p<0.02 ) , and TNF-α ( r=0.39 , p<0.05 ) in hypertensive patients . By multivariate analysis , IL-6 and TNF-α were significant independent predictors of CVR during CPT . Elevated plasma IL-6 and TNF-α levels were independent predictors of coronary endothelial dysfunction in hypertensive patients . These results suggest that plasma IL-6 and TNF-α might be useful for identifying the high risk subgroup of hypertensive patients with coronary endothelial dysfunction and provide an important clue to link systemic inflammation to the development of coronary atherosclerosis Obesity is associated with vascular endothelial dysfunction , as indicated by impaired endothelium-dependent dilation . Presently there is no direct evidence that energy intake – restricted weight loss alone improves conduit or resistance artery endothelium-dependent dilation , the mechanisms involved , or whether improvements differ with patient age . A total of 40 overweight or obese ( body mass index : ≥25<40 kg/m2 ) nondiabetic men and women aged 21 to 69 years completed 12 weeks of reduced energy intake ( n=26 ; 15 male ) or attention control ( n=14 ; 9 male ) and 4 weeks of weight maintenance ( r and omized trial ) . Energy intake restriction reduced estimated total energy intake ( 33 % ) , body weight ( 10.5 % ) , total and abdominal body fat , plasma leptin , oxidized low-density lipoprotein , and improved several metabolic risk factors . Brachial artery flow-mediated dilation was increased by 30 % ( 6.0±0.7 % versus 7.9±0.7%&Dgr ; ; P=0.01 ; n=17 ) . Peak forearm blood flow during intrabrachial artery infusion of acetylcholine was increased by 26 % ( 16.8±1.4 versus 21.1±1.9 mL/100 mL per minute ; P<0.05 ; n=15 ) ; this was inversely related to the reduction in the abdominal visceral : subcutaneous fat ratio ( r=−0.46 ; P<0.05 ) and was abolished by inhibition of NO synthesis with NG-monomethyl-l-arginine . Improvements in endothelium-dependent dilation were not related to age : mean increases in subjects > 50 years of age were similar to or greater than those < 50 years of age . Energy intake – restricted weight loss alone is an effective intervention for improving peripheral conduit and resistance artery endothelial function in young and older overweight/obese adults . The improvements in resistance artery function are mediated by an increase in NO bioavailability and are related to reductions in abdominal visceral fat As a competitive inhibitor of endothelial nitric oxide synthase , asymmetric dimethylarginine ( ADMA ) has been related to atherosclerotic disease . Little is known about the prognostic impact of baseline ADMA determination . In a prospect i ve cohort of 1908 patients with coronary artery disease , we assessed baseline serum concentration of ADMA in 1874 consecutive patients with coronary artery disease . One hundred fourteen individuals developed the primary end point of death from cardiovascular causes or nonfatal myocardial infa rct ion during a mean follow-up of 2.6±1.2 years . Median concentrations of ADMA levels were higher among individuals who subsequently developed the primary end point than among those who did not ( 0.70 versus 0.63 & mgr;mol/L ; P<0.001 ) . The risk of future cardiovascular event was associated with increasing thirds of baseline ADMA ( P for trend , < 0.001 ) such that individuals in the highest third at entry had a hazard ratio 2.48 times higher than those in the lowest third ( 95 % confidence interval , 1.52 to 4.06 ; P<0.001 ) . This relationship remained nearly unchanged after adjustment for most potential confounders . Prediction models that simultaneously incorporated ADMA , B-type natriuretic peptide , C-reactive protein , and creatinine in addition to traditional risk factors revealed B-type natriuretic peptide ( hazard ratio , 1.96 ; 95 % confidence interval , 1.3 to 3.0 ; P=0.002 ) and ADMA ( hazard ratio , 1.90 ; 95 % confidence interval , 1.3 to 2.8 ; P=0.001 ) as the strongest risk predictors . High levels of baseline ADMA independently predict future cardiovascular risk . ADMA has prognostic value beyond traditional risk factors and novel biomarkers and might guide therapeutic strategies OBJECTIVE Diabetic patients have a reduced endothelial response to phosphodiesterase-5 inhibitors . The aim of this study was to determine the effects of chronic therapy with sildenafil on endothelial function in patients with Type 2 diabetes mellitus ( DM2 ) . METHODS In a double-blind , placebo-controlled parallel design , 20 patients without erectile dysfunction r and omly received a loading dose of sildenafil ( 100 mg ) for 3 days , followed by either sildenafil 25 mg three times a day ( t.d.s . ) for 4 weeks or sildenafil 25 mg t.d.s . for 4 days followed by placebo t.d.s . for 3 weeks . RESULTS After 1 week , flow-mediated dilatation ( FMD ) improved significantly ( > 50 % compared with baseline ) in patients allocated to both sildenafil arms ( 62 and 64 % , respectively ) . In patients allocated to chronic sildenafil , a progressive increase in percentage of patients with FMD improvement was noted ( 78 , 86 and 94 % at 2 , 3 and 4 weeks , respectively ) while a progressive decrease in the placebo group occurred ( 45 , 18 and 6 % at 2 , 3 and 4 weeks , respectively ) . At the end of the study , a significant improvement in FMD compared with baseline was noted after chronic sildenafil ( FMD from 6.8 + /- 0.5 to 12.5 + /- 0.7 % , P = 0.01 vs. baseline ) . A decrease in endothelin-1 levels and an increase in nitrite/nitrate levels were found after chronic sildenafil ; significant changes from baseline in C-reactive protein , interleukin 6 , intercellular adhesion molecule and vascular adhesion molecule levels were also found . CONCLUSIONS In DM2 patients , daily sildenafil administration improves endothelial function and reduces markers of vascular inflammation , suggesting that the diabetes-induced impairment of endothelial function may be improved by prolonged phosphodiesterase-5 inhibition The preponderance of evidence states that , in adult men , estradiol ( E2 ) inhibits LH secretion by decreasing pulse amplitude and responsiveness to GnRH consistent with a pituitary site of action . However , this conclusion is based on studies that employed pharmacologic doses of sex steroids , used nonselective aromatase inhibitors , and /or were performed in normal ( NL ) men , a model in which endogenous counterregulatory adaptations to physiologic perturbations confound interpretation of the results . In addition , studies in which estrogen antagonists were administered to NL men demonstrated an increase in LH pulse frequency , suggesting a potential additional hypothalamic site of E2 feedback . To reconcile these conflicting data , we used a selective aromatase inhibitor , anastrozole , to examine the impact of E2 suppression on the hypothalamic-pituitary axis in the male . Parallel studies of NL men and men with idiopathic hypogonadotropic hypogonadism ( IHH ) , whose pituitary-gonadal axis had been normalized with long-term GnRH therapy , were performed to permit precise localization of the site of E2 feedback . In this so-called t and em model , a hypothalamic site of action of sex steroids can thus be inferred whenever there is a difference in the gonadotropin responses of NL and IHH men to alterations in their sex steroid milieu . A selective GnRH antagonist was also used to provide a semiquantitative estimate of endogenous GnRH secretion before and after E2 suppression . Fourteen NL men and seven IHH men were studied . In Exp 1 , nine NL and seven IHH men received anastrozole ( 10 mg/day po x 7 days ) . Blood sample s were drawn daily between 0800 and 1000 h in the NL men and immediately before a GnRH bolus dose in the IHH men . In Exp 2 , blood was drawn ( every 10 min x 12 h ) from nine NL men at baseline and on day 7 of anastrozole . In a subset of five NL men , 5 microg/kg of the Nal-Glu GnRH antagonist was administered on completion of frequent blood sampling , then sampling continued every 20 min for a further 8 h. Anastrozole suppressed E2 equivalently in the NL ( 136 + /- 10 to 52 + /-2 pmol/L , P < 0.005 ) and IHH men ( 118 + /- 23 to 60 + /- 5 pmol/L , P < 0.005 ) . Testosterone levels rose significantly ( P < 0.005 ) , with a mean increase of 53 + /- 6 % in NL vs. 56 + /- 7 % in IHH men . Despite these similar changes in sex steroids , the increase in gonadotropins was greater in NL than in IHH men ( 100 + /- 9 vs. 58 + /- 6 % for LH , P = 0.07 ; and 85 + /- 6 vs. 41 + /- 4 % for FSH , P < 0.002 ) . Frequent sampling studies in the NL men demonstrated that this rise in mean LH levels , after aromatase blockade , reflected an increase in both LH pulse frequency ( 10.2 + /- 0.9 to 14.0 + /- 1.0 pulses/24 h , P < 0.05 ) and pulse amplitude ( 5.7 + /- 0.7 to 8.4 + /- 0.7 IU/L , P < 0.001 ) . Percent LH inhibition after acute GnRH receptor blockade was similar at baseline and after E2 suppression ( 69.2 + /- 2.4 vs. 70 + /- 1.9 % ) , suggesting that there was no change in the quantity of endogenous GnRH secreted . From these data , we conclude that in the human male , estrogen has dual sites of negative feedback , acting at the hypothalamus to decrease GnRH pulse frequency and at the pituitary to decrease responsiveness to GnRH OBJECTIVES We examined the predictive power of erectile dysfunction ( ED ) on coronary heart disease ( CHD ) events in Chinese men with type 2 diabetes . BACKGROUND Subjects with diabetes are prone to develop cardiovascular complications . Erectile dysfunction is strongly associated with CHD in cross-sectional studies , but prospect i ve data are lacking . METHODS A consecutive cohort of men with no clinical evidence of cardiovascular disease underwent comprehensive assessment s for diabetic complications . Erectile dysfunction was defined according to the definition of the National Institutes of Health Consensus Conference 1992 . Coronary heart disease events were censored with central ized territory-wide hospital data bases in 2005 . RESULTS Of 2,306 subjects ( age : 54.2 + /- 12.7 years ; follow-up : 4.0 [ range 1.7 to 7.1 ] years ) , 26.7 % had ED at baseline . The incidence of CHD events was higher in men with ED than those without ( 19.7/1,000 person-years , 95 % confidence interval [ CI ] 14.3 to 25.2 person-years vs. \n Output:\n " }, { "from": "agent", "value": "In addition to male hypogonadism and macrovascular disease , endothelial dysfunction is central to the connection between the metabolic syndrome and ED .\nConversely , improved glycemic control and weight loss have been found to improve erectile function .\nCONCLUSION ED is very prevalent in men with DM and obesity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study examined the therapeutic role of a structured life review process in a r and omly selected group of 60 homebound elderly subjects . Subjects were placed in three groups and tested on four dependent variables at the beginning and end of an 8-week period . These variables were life satisfaction , psychological well-being , depression , and activities of daily living ( ADL ) . One group , the experimental group , received the treatment of life review process ; another , the control group , received a friendly visit ; and the third , the no-treatment group , received pretests and posttests only . Two dependent variables , life satisfaction , as operationalized by the Life Satisfaction Index A ( LSIA ) , and psychological well-being , as operationalized by the Affect-Balance Scale ( ABS ) , were significant in the experimental group when tested statistically through analysis of covariance ( ANCOVA ) . These results suggest that a structured process of life review can serve as a therapeutic intervention for homebound elderly persons OBJECTIVES Based on the model by Tsang et al. ( 2002 ) which summarized the etiological factors and consequences of depression in elderly with chronic physical illnesses , a r and omized clinical trial of a special form of Qigong ( The Eight Section Brocades ) was conducted to assess if it improved the biopsychosocial health of participants . DESIGN 50 geriatric patients in sub-acute stage of chronic physical illnesses were recruited and r and omly assigned into the intervention and control group . The intervention group was given a 12-week period of Qigong practice while the control group was given traditional remedial rehabilitation activities . RESULTS The intervention group participants expressed improvement in physical health , ADL , psychological health , social relationship , and health in general as reflected by scores of the Perceived Benefit Question naire and informal feedback . CONCLUSION Although results are not significant in the generalization measures , it may be due to small effect size , small sample size , and short intervention period . Although not all of the hypotheses are supported , this report shows that Qigong ( the Eight Section Brocades ) is promising as an alternative intervention for elderly with chronic physical illness to improve their biopsychosocial health . More systematic evaluation with larger sample size and longer period of intervention is now underway in Hong Kong . Results will be reported once available OBJECTIVES Determine the impact of an 8-week mindfulness meditation program on disability , psychological function , and pain severity in community-dwelling older adults with chronic low back pain , and to test the education control program for feasibility . DESIGN R and omized controlled trial . Participants . Forty community-dwelling older adults with moderate low back pain or greater for at least the previous 3 months . Intervention . Participants were r and omized to an 8-week meditation program or an 8-week education control program . OUTCOME MEASURES Disability , psychological function , and pain severity were assessed . The same measures were obtained for both groups at baseline , at the end of the program , and 4 months after program completion . RESULTS Sixteen participants ( 80 % ) completed the meditation program and 19 ( 95 % ) completed the education program . Both the meditation and control group improved on measures of disability , pain , and psychological function , both at program completion and 4-month follow-up . The differences between the two groups did not reach statistical significance . The meditation group practice d mindfulness meditation a mean of 5 days/week ( range 1 - 7 ) and mean of 31 minutes/session ( range 22 - 48 ) . At 4 months follow-up 14/16 ( 88 % ) participants continued to meditate . CONCLUSION Both the intervention group and the education control group improved on outcome measures suggesting both programs had a beneficial effect . Participants continued to meditate on 4-month follow-up . The control program was feasible but not inert . Piloting the control program in mind-body research can inform the design of larger clinical trials Background : Few studies have considered the neighborhood as a context in which to examine the physical activity and quality of life relationship . Purpose : The goal of this study was to evaluate the effects of a neighborhood walking program on quality of life among older adults . It was design ed as a r and omized trial involving a multilevel design with neighborhoods corresponding to primary sampling units and residents to secondary units . Methods : Five hundred eighty-two communitydwelling senior residents ( 65 years of age or older ) in neighborhoods in the northeast metropolitan area of Portl and , Oregon , were recruited through telephone , direct mail , and referrals . The walking intervention was delivered at the neighborhood level . Neighborhoods ( N = 56 ) were r and omly assigned to a 6-month , 3 times per week , leader-led walking group activity ( n = 28 ) or an information-only control group ( n = 28 ) . Primary outcome measures included SF-12 ( Physical , Mental summary scores ) and life satisfaction ( SWLS ) ; the secondary outcome measure was neighborhood walking activity , assessed at baseline , 3 months , and 6 months of the study period . Results : Compared to the control neighborhoods , results from multilevel , longitudinal analyses indicated significant improvements in the primary outcomes of SF-12 Physical ( p < .05 ) , SF-12 Mental ( p < .05 ) summary scores , and SWLS ( p < .05 ) , over the course of the 6-month intervention . A significant increase was also observed in the secondary outcome of walking activity ( p < .05 ) . Conclusions : Implementing a neighborhood-based walking program of low to moderate intensity is feasible and beneficial for promoting quality of life among senior residents at a community level UNLABELLED To identify the effects of mindfulness meditation on older adults with chronic low back pain ( CLBP ) , we conducted a qualitative study based on grounded theory and used content analysis of diary entries from older adults who had participated in a clinical trial of an 8-week mindfulness meditation program . Participants were 27 adults > or = 65 years of age with CLBP of at least moderate severity and of at least 3 months duration . We found several themes reflecting the beneficial effects of mindfulness meditation on pain , attention , sleep , and achieving well-being . Various methods of pain reduction were used , including distraction , increased body awareness leading to behavior change , better pain coping , and direct pain reduction through meditation . Participants described improved attention skills . A number of participants reported improved sleep latency as well as quality of sleep . Participants described achieving well-being during and after a meditation session that had immediate effects on mood elevation but also long-term global effects on improved quality of life . Several themes were identified related to pain reduction , improved attention , improved sleep , and achieving well-being result ing from mindfulness meditation that suggest it has promising potential as a nonpharmacologic treatment of chronic pain for older adults . PERSPECTIVE Community-dwelling older adults with chronic low back pain experience numerous benefits from mindfulness meditation including less pain , improved attention , better sleep , enhanced well-being , and improved quality of life . Additional research is needed to determine how mindfulness meditation works and how it might help with other chronic illnesses Background and aims : The aim of this study was to assess the effects of risk-based multifactorial fall prevention program on maximal isometric strength in the community-dwelling aged . Methods : 591 subjects were r and omized in two age groups ( 65–74 and ≥75 yrs ) , intervention group ( IG ) ( n=293 ) and control group ( CG ) ( n=298 ) . A 12-month program consisted of individual geriatric assessment , individual guidance on fall prevention , home hazards assessment , physical exercises in groups , lectures , psychosocial activity groups , and home exercises . Strength was measured on an adjustable dynamometer chair . Results : Among women , the extension strength of the left knee increased by 7 % in IG and 2 % in CG ( p=0.006 ) , and that of the right knee by 7 % and 4 % ( p=0.057 ) , respectively . Subgroup analyses in the two age groups revealed a significant difference between groups among men aged 65–74 yrs , in favour of CG subjects , whose flexion strength of the left knee increased by 14 % whereas the corresponding increase in IG was only 1 % ( p=0.042 ) . Among women aged 65–74 yrs , the extension strength of right ( increase of 8 % in IG , 4 % in CG ) ( p=0.046 ) and left knees ( 9 % and 3 % ) ( p=0.008 ) and flexion strength of right ( 10 % and 4 % ) ( p=0.042 ) and left knees ( 10 % and 4 % ) ( p=0.041 ) increased more in IG than in CG . Conclusions : The 12-month fall prevention program increased maximal isometric muscle strength among women only , especially those aged 65–74 years . We suggest that more intensive exercise , including the use of extra weights or resistance , is needed to increase muscle strength in men AIM This paper is a report of a study to explore the effects of psychosocial group nursing intervention on older people 's feelings of loneliness , social activity and psychological well-being . BACKGROUND Older people 's loneliness is associated with low quality of life , and impaired health , increased use of health and social services and increased mortality . Previous intervention studies have achieved quite modest results . METHOD A r and omized controlled trial was conducted between 2003 and 2006 using a group intervention aim ed at empowering older people , and promoting peer support and social integration . A total of 235 people ( > 74 years ) suffering from loneliness met 12 times with professional leaders in groups . The UCLA Loneliness Scale and Lubben 's Social Network Scale were used at entry , after 3 and 6 months . Psychological well-being was charted using a six-dimensional question naire at baseline and 12 months later . FINDINGS A statistically significantly larger proportion of intervention group participants had found new friends during the follow-up year ( 45 % vs. 32 % , P = 0.048 ) , and 40 % of intervention group participants continued their group meetings for 1 year . However , no differences were found in loneliness or social networks between the groups . Psychological well-being score improved statistically significantly in the intervention groups [ + 0.11 , 95 % confidence interval ( CI ) : + 0.04 to + 0.13 ] , compared with the controls ( + 0.01 , 95 % CI : -0.05 to + 0.07 , P = 0.045 ) . Feeling needed was statistically significantly more common in the intervention groups ( 66 % ) than in controls ( 49 % , P = 0.019 ) . CONCLUSION New sensitive measurements of loneliness and social isolation are needed to measure fluctuations in feelings of loneliness and in social isolation OBJECTIVES The aim was to determine the effects of multifactorial fall prevention on depressive symptoms among aged Finns at increased risk of falling . METHODS This study is part of a multifactorial fall prevention trial with a r and omised controlled design implemented in the town of Pori , western Finl and . The study population consisted of ambulatory , 65-year-old or older Finns , with moderate or high cognitive and physical abilities who had fallen at least once during the previous 12 months . The participants ( n=591 ) were r and omised into a risk-based multifactorial fall prevention programme ( intervention group , IG ) or into a one-time counselling group ( control group , CG ) . The 1-year intervention included individual geriatric assessment followed by treatment recommendations , individual guidance regarding fall prevention , physical exercise in small groups twice a month , psychosocial group activities and lectures once a month , home-exercises and home hazard assessment . The outcome , depressive symptoms , was measured by the 30-item Geriatric Depression Scale ( GDS ) . RESULTS The full GDS data with no missing items were available for 464 persons . A significant decrease in depressive symptoms during the 12-month intervention was found both in IG and in CG , but the difference in change was not significant ( p=0.110 ) . However , a significant difference in change between the groups was found among men and older subjects ( > or=75 ) in favour of the IG . CONCLUSION Multifactorial fall prevention had no effects on depressive symptoms among the community-dwelling aged . However , men and older participants benefited from the intervention The objective of this study was to determine the impact of an aerobic physical exercise program in the treatment of a group of elderly patients with type 2 diabetes mellitus ( DM ) in relation to metabolic control , physical capacity , quality of life ( QOL ) and attitudes toward diabetes . Patients were r and omly assigned to either an experimental ( n=19 ) or a control ( n=20 ) group . The following measurements were conducted at baseline and after week 16 : glycosylated hemoglobin ( hbA1c ) , fructosamine , 3 h oral glucose tolerance test , treadmill test ( Balke-Naughton ) , and a question naire on QOL and attitudes toward DM . After the intervention , the experimental group showed a significant decrease of glucose excursion during the oral glucose tolerance test ( OGTT ) ( area under the curve ) ( 16.6+/-3.8 vs. 15.3+/-3.1 , P<0.05 ) and an increase in total time on the treadmill ( s ) ( 423+/-207 vs. 471+/-230 , P<0.05 ) . An improvement in the attitudes toward DM was observed in the experimental group ( P=0.01 ) but not in the control group . Female gender , higher body mass index and hbA1c were factors associated with a response to the intervention . This study suggests that physical exercise has significant effects on glucose excursion during an OGTT and exercise tolerance in elderly patients with type 2 DM BACKGROUND \n Output:\n " }, { "from": "agent", "value": "Overall , psychosocial interventions had a positive effect on quality of life and positive mental health .\nThe pooled interventions also had a statistically significant effect on reduction in depressive symptoms .\nSocial activities significantly improved positive mental health , life satisfaction and quality of life and reduced depressive symptoms .\nBased on the results of this study , duration of interventions is of importance , since interventions lasting for > 3 months exhibited more positive effects compared with shorter interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Background : Although protein-rich plant foods have recently been touted as an equivalent to animal products , limited data exist regarding the effects of animal vs. plant proteins on appetite , satiety , and subsequent food intake . Objective : The objective was to determine whether a high-protein beef lunch alters the appetitive , hormonal , and neural signals controlling food intake regulation vs. a macronutrient and fiber – matched ( MF ) or serving size – matched ( SS ) soy lunch in healthy adults . Methods : A r and omized , double-blind , crossover design study was completed in 21 adults ( aged 23 ± 1 y ; body mass index : 23.8 ± 0.6 kg/m2 ; mean ± SEM ) to compare 400-kcal MF and SS lunches varying in protein quality . The MF lunches contained 24-g beef protein or 24-g soy protein , whereas the SS lunches contained 1 serving of beef ( 24-g protein/1-g fiber ) or soy ( 14-g protein/5-g fiber ) . Pre- and postlunch appetite question naires and blood sampling were completed over an 8-h period until dinner was voluntarily requested . In addition , pre- and postlunch functional MRI brain scans were completed to assess neural activation in response to food stimuli . Results : On average , dinner was requested at ∼250 ± 20 min postlunch with no differences between beef vs. soy within the MF and SS conditions . Furthermore , no differences in hunger , fullness , peptide YY , or glucagon-like peptide-1 responses were observed after the beef vs. soy lunches within the MF and SS conditions . The SS beef meal led to reductions in anterior cingulate activation ( −22 ± 6 % ) vs. soy ( + 7 ± 9%;P < 0.01 ) and greater reductions in insular activation ( −30 ± 6 % ) vs. SS soy ( −7 ± 10%;P < 0.01 ) . The participants consumed ∼945 ± 78 kcal after the MF meals and 910 ± 74 kcal after the SS meals with no differences between beef vs. soy . Conclusions : When comparing 2 high- quality protein sources , such as beef and soy , the type of protein consumed within a mixed meal elicited very little effect on appetite , satiety , and food intake in healthy adults . This study was registered at clinical trials.gov as NCT02285907 BACKGROUND Effects of protein intake on appetite-regulating hormones and their dynamics are unclear . OBJECTIVES We investigated the satiating effects of meals with varying protein contents and whether there was an effect of dose on appetite-regulating hormones and appetite ratings . DESIGN Twenty-five men [ mean ± SD age : 30.0 ± 8.7 y ; body mass index ( BMI ; in kg/m(2 ) ) : 25.9 ± 4.7 ] participated in the 3-way , r and omized , double-blind crossover study . Test meals were isocaloric with 30 % of energy from fat and protein content adjusted at the expense of carbohydrate . Test meals were normal protein ( NP ; 14 % of energy from protein ) , medium-high protein ( MHP ; 25 % of energy from protein ) , and high protein ( HP , 50 % of energy from protein ) . Appetite ratings and blood sample s were assessed every 0.5 h for 4 h. An ad libitum lunch was served 4 h after the meal . RESULTS Protein increased dose-dependently glucagon-like peptide-1 ( GLP-1 ) , peptide YY ( PYY ) 3 - 36 , and glucagon ; MHP produced 10 % , 7 % , and 47 % greater responses , respectively ; and HP produced 20 % , 14 % , and 116 % greater responses , respectively , than did NP ( P < 0.03 ) . Compared with NP , HP increased insulin and cholecystokinin and decreased ghrelin and glucose-dependent insulinotropic polypeptide ( P < 0.05 ) . Satiety and fullness dose-dependently increased by 7 % and 6 % for MHP and 16 % and 19 % for HP compared with NP ( P < 0.001 ) . Hunger and prospect i ve consumption dose-dependently decreased by 15 % and 13 % for MHP and by 25 % and 26 % for HP compared with NP ( P < 0.0003 ) . There was a combined effect of GLP-1 and PYY 3 - 36 ( P = 0.03 ) next to the additive effect of GLP-1 ( P = 0.006 ) on the composite appetite score . No difference was shown in ad libitum energy intake . CONCLUSION Protein dose-dependently increased satiety and GLP-1 , PYY 3 - 36 , and glucagon , which may , at least in part , be responsible for the satiety-stimulating effect of protein . This trial was registered at clinical trials.gov as NCT01561235 Background / Objectives : Intake of food or fluid distends the stomach and triggers mechanoreceptors and vagal afferents . Wall stretch and tension produces a feeling of fullness . Duodenal infusion studies assessing gastric sensitivity by barostat have shown that the products of fat digestion have a greater effect on the sensation of fullness and also dyspeptic symptoms than carbohydrates . We tested here the hypothesis that fat and carbohydrate have different effects on gastric sensation under physiological conditions using non-invasive magnetic resonance imaging ( MRI ) to measure gastric volumes . Subjects/ Methods : Thirteen healthy subjects received a rice pudding test meal with added fat or added carbohydrate on two separate occasions and underwent serial postpr and ial MRI scans for 4.5 h. Fullness was assessed on a 100-mm visual analogue scale . Results : Gastric half emptying time was significantly slower for the high-carbohydrate meal than for the high-fat meal , P=0.0327 . Fullness significantly correlated with gastric volumes for both meals ; however , the change from baseline in fullness scores was higher for the high-fat meal for any given change in stomach volume ( P=0.0147 ) , despite the lower energy content and faster gastric emptying of the high-fat meal . Conclusions : Total gastric volume correlates positively and linearly with postpr and ial fullness and ingestion of a high-fat meal increases this sensation compared with high-carbohydrate meal . These findings can be of clinical interest in patients presenting with postpr and ial dyspepsia whereby manipulating gastric sensitivity by dietary intervention may help to control digestive sensations BACKGROUND Dietary fibers have been associated with a reduction in appetite and energy intake . Although a few studies suggest that nonviscous fibers can exert such effects , likely through colonic fermentation , limited data are available . OBJECTIVE The objective of this study was to determine whether α-galacto-oligosaccharides ( α-GOSs ) , fermentable soluble fibers extracted from legumes , could reduce appetite , food intake , and inflammation in overweight subjects . METHODS In 2 single-center , double-blind , r and omized , placebo-controlled trials , 88 overweight adults [ 50 % men and 50 % women ; 18 - 60 y old ; body mass index ( in kg/m(2 ) ) : 25 - 28 ] were supplemented for 14 d with tea that contained α-GOSs with different α-GOS dosages ( 6 , 12 , or 18 g α-GOSs/d ) , formulas ( 12 g α-GOSs/d with > 80 % of molecules with a degree of polymerization of 2 , 3 , or 4 ) , or a control substance ( glucose syrup ) . Appetite scores ( 5 appetite dimensions were assessed on visual analog scales during a preload test meal ) , food intake ( test meal and 24-h food recall ) , and inflammatory markers [ plasma lipopolysaccharide ( LPS ) and C-reactive protein ( CRP ) ] were evaluated at day 0 ( baseline ) and day 15 . RESULTS Changes in appetite scores from day 0 to day 15 were significantly higher after α-GOS intake , with areas under the curve for the satiety score of + 121 ± 108 , + 218 ± 218 , and + 306 ± 205 score · min for 6 , 12 , and 18 g α-GOSs/d , respectively , and -5 ± 64 score · min for the control group . We observed dose-dependent effects that did not vary by α-GOS composition . The administration of 6 , 12 , or 18 g α-GOSs/d significantly and dose-dependently increased the change in energy intake from day 0 to day 15 during a test meal ( -13 ± 19 , -26 ± 22 , and -32 ± 22 kcal , respectively ; + 6 ± 21 kcal for the control group ) . Reductions in energy intake during lunch and dinner were also higher in the α-GOS groups in the dose-effect study . At day 15 , LPS was dose-dependently reduced without an association with α-GOS composition ( 0.16 ± 0.02 , 0.12 ± 0.08 , and 0.08 ± 0.05 EU/mL for 6 , 12 , and 18 g α-GOSs/d , respectively , and 0.06 ± 0.04 EU/mL for the control group ) and CRP was significantly lower in the α-GOS groups than in the control group in the formulation-effect study . CONCLUSIONS Consumption of α-GOSs for 14 d dose-dependently reduced appetite , food intake , and inflammation in overweight adults with no impact of α-GOS composition . Consequently , α-GOSs appear to promote long-term weight loss and mitigate metabolic disorders Background Whole grain has shown potential to prevent obesity , cardiovascular disease and type 2 diabetes . Possible mechanism could be related to colonic fermentation of specific indigestible carbohydrates , i.e. dietary fiber ( DF ) . The aim of this study was to investigate effects on cardiometabolic risk factors and appetite regulation the next day when ingesting rye kernel bread rich in DF as an evening meal . Method Whole grain rye kernel test bread ( RKB ) or a white wheat flour based bread ( reference product , WWB ) was provided as late evening meals to healthy young adults in a r and omized cross-over design . The test products RKB and WWB were provided in two priming setting s : as a single evening meal or as three consecutive evening meals prior to the experimental days . Test variables were measured in the morning , 10.5–13.5 hours after ingestion of RKB or WWB . The postpr and ial phase was analyzed for measures of glucose metabolism , inflammatory markers , appetite regulating hormones and short chain fatty acids ( SCFA ) in blood , hydrogen excretion in breath and subjective appetite ratings . Results With the exception of serum CRP , no significant differences in test variables were observed depending on length of priming ( P>0.05 ) . The RKB evening meal increased plasma concentrations of PYY ( 0–120 min , P<0.001 ) , GLP-1 ( 0–90 min , P<0.05 ) and fasting SCFA ( acetate and butyrate , P<0.05 , propionate , P = 0.05 ) , compared to WWB . Moreover , RKB decreased blood glucose ( 0–120 min , P = 0.001 ) , serum insulin response ( 0–120 min , P<0.05 ) and fasting FFA concentrations ( P<0.05 ) . Additionally , RKB improved subjective appetite ratings during the whole experimental period ( P<0.05 ) , and increased breath hydrogen excretion ( P<0.001 ) , indicating increased colonic fermentation activity . Conclusion The results indicate that RKB evening meal has an anti-diabetic potential and that the increased release of satiety hormones and improvements of appetite sensation could be beneficial in preventing obesity . These effects could possibly be mediated through colonic fermentation . Trial Registration Clinical Trials.gov Background Dietary fibers are associated with enhanced satiety . However , the mechanism of different dietary fibers contributing to satiety-related gastrointestinal ( GI ) peptide release , especially in an obese population , is still poorly understood . Polydextrose ( PDX ) , a water-soluble glucose polymer , has demonstrated its ability to reduce energy intake at a subsequent meal , but its mechanism of action requires further research . Also , there is limited evidence on its capacity to regulate subjective feelings of appetite . This study examines the effects of PDX on postpr and ial secretion of satiety-related GI peptides , short chain fatty acids ( SCFAs ) , lactic acid , and subjective appetite ratings in obese participants . Methods 18 non-diabetic , obese participants ( 42.0 y , 33.6 kg/m2 ) consumed a high-fat meal ( \n Output:\n " }, { "from": "agent", "value": "The effect of higher protein intake on appetite sensation has been well documented with positive results , whereas dietary fibers , although the majority of evidence suggests positive results , still show inconsistent data because of various method ological approaches ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We previously reported that higher serum concentrations of C-reactive protein ( CRP ) are associated with shorter survival in men with castration-resistant prostate cancer ( CRPC ) . To confirm this finding in an independent data set , we used 119 CRPC patients enrolled in 6 phase II clinical trials and examined the relationship of CRP , alkaline phosphatase , hemoglobin , age , ECOG PS , and prostate specific antigen ( PSA ) with survival . Median follow-up was 19.7 months ( 0.9 - 98.5 months ) , and 89 % have died . After analyzing the form of the risk function using the generalized additive model method , univariate and multivariate Cox proportional hazard models were used to assess associations between baseline individual categorical and continuous variables . Quartiles of CRP were : 0 - 1.0 , 1.1 - 4.9 , 5.0 - 17.0 , and 17.1 - 311 mg/L. In a Cox multivariate model , log(2 ) ( CRP ) ( HR 1.106 , P = 0.013 ) as well as hemoglobin and alkaline phosphatase were independently associated with survival , confirming that higher CRP is associated with shorter survival in CRPC . Since CRP is a marker of inflammation , this finding suggests that inflammation may play an important role in the natural history of advanced prostate cancer . CRP is a readily measurable biomarker that has the potential to improve prognostic models and should be vali date d in a prospect i ve clinical trial Interleukin-6 plays a central role in normal B-cell maturation and in proliferation of some B-cell malignancies including multiple myeloma and some non Hodgkin 's lymphomas ( NHL ) . Furthermore , this cytokine also plays a major role in acute phase response by mediating synthesis of acute phase proteins such as C-reactive protein ( CRP ) . In order to evaluate the exact role of CRP serum level as a simple prognostic factor , we analyzed CRP and IL-6 serum levels in 39 patients with NHL . Eleven patients had low grade NHL , 15 intermediate grade NHL , and 13 high grade NHL . Thirty percent of the patients presented detectable IL-6 serum levels ( mean+/-SD : 33.6+/-95.2 U/ml , range : 0 to 500 ) . Increased serum CRP levels were found in 42 % of the patients with a mean of 29.2+/-41.97 mg/l ] ( range : 0 to 129 ) . Thirty seven patients were studied for both markers . Three groups of patients were determined . One with low IL-6 and CRP serum levels ( N=21 ) , a second with high level of both markers ( N=10 ) , and the third with high serum CRP levels alone ( N = 5 ) . Only one patient had high level of serum IL-6 with no detectable CRP . The correlation of serum IL-6 and CRP levels with patient survival was investigated . Median survival in the group with low IL-6 level was not reached . 67 % of patients of this group were still alive at 32 months from diagnosis . The group of patients with detectable IL-6 had a median of survival of 12 months ( p<0.025 ) . The survival of patients with a CRP<10 mg/l was not reached . 75 % of patients survive at 32 months from diagnosis , whereas the group with higher CRP level reached a median survival at 8.5 months ( p<0.009 ) . As expected , on univariate analysis , there is a significant relationship between CRP and IL-6 levels ( p<0.00017 ) , and CRP levels and B symptoms ( p<0.001 ) . Furthermore there is a significant relationship between CRP and LDH levels (p<0.042).These results indicated that CRP may be considered as a valuable and easy prognostic biomarker of NHL BACKGROUND Sipuleucel-T , an autologous active cellular immunotherapy , has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer . METHODS In this double-blind , placebo-controlled , multicenter phase 3 trial , we r and omly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T ( 341 patients ) or placebo ( 171 patients ) administered intravenously every 2 weeks , for a total of three infusions . The primary end point was overall survival , analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen ( PSA ) and lactate dehydrogenase . RESULTS In the sipuleucel-T group , there was a relative reduction of 22 % in the risk of death as compared with the placebo group ( hazard ratio , 0.78 ; 95 % confidence interval [ CI ] , 0.61 to 0.98 ; P=0.03 ) . This reduction represented a 4.1-month improvement in median survival ( 25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group ) . The 36-month survival probability was 31.7 % in the sipuleucel-T group versus 23.0 % in the placebo group . The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test ( hazard ratio , 0.77 ; 95 % CI , 0.61 to 0.97 ; P=0.02 ) and after adjustment for use of docetaxel after the study therapy ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ; P=0.03 ) . The time to objective disease progression was similar in the two study groups . Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills , fever , and headache . CONCLUSIONS The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer . No effect on the time to disease progression was observed . ( Funded by Dendreon ; Clinical Trials.gov number , NCT00065442 . \n Output:\n " }, { "from": "agent", "value": "Conclusion : This meta- analysis suggests a detrimental impact for CRP on OS in MPC ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Atypical antipsychotics have been shown to improve disruptive and repetitive behaviors in pervasive developmental disorders ( PDDs ) , but they require assessment of potential side effects . This is the first placebo-controlled trial of olanzapine in the treatment of children and adolescents with PDD . Eleven patients with a diagnosis of either autism , Asperger 's syndrome , or PDD not otherwise specified ( PDD-NOS ) and aged 6 - 14 years were r and omized into an 8-week double-blind , placebo-controlled , parallel treatment study with olanzapine . There was a significant linear trend x group interaction on the Clinical Global Impressions- Improvement ( CGI-I ) and 50 % on olanzapine versus 20 % on placebo were responders . Olanzapine was associated with significant weight gain ( 7.5 + /- 4.8 lbs vs. 1.5 + /- 1.5 lbs on placebo ) . Olanzapine may be a promising treatment for improving global functioning of PDDs , but the risk of significant weight gain remains a concern . Additional studies are needed to determine the efficacy and safety of olanzapine in the treatment of children with PDD OBJECTIVE The authors studied weight gain mechanisms and energy balance in patients treated with olanzapine . METHOD The body mass index of male schizophrenic adolescent in patients treated with olanzapine ( N=10 ) and of 10 matched patients treated with haloperidol ( N=10 ) were measured at baseline and after 4 weeks of treatment . For the patients treated with olanzapine , caloric intake , resting energy expenditure , and physical activity ( determined through accelerometry and heart rate monitoring ) were assessed at baseline and after 4 weeks of treatment . RESULTS Body mass index significantly increased in those treated with olanzapine but not in those given haloperidol . The increase in body mass index was due to an increase in caloric intake without change in diet composition . Olanzapine had no significant effect on resting energy expenditure . Daily energy expenditure was very low before and after treatment . CONCLUSIONS Olanzapine-induced weight gain is associated with a general increase in caloric intake 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 , r and omized , placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder , aged 6 - 17 years . Subjects were stratified by PAE ; adverse events ( AEs ) , and changes in weight , and metabolic measures were evaluated . 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 r and omized subjects , 259 ( 82.0 % ) were antipsychotic naïve ( AN ) and 57 ( 18.0 % ) had a PAE . 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 % ) . Rates of extrapyramidal disorder and drooling , but not akathisia or tremor , were marginally higher in AN subjects . 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 . 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 ) . Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain . 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 . AN subjects were more likely to experience AEs related to somnolence . However , based on discontinuations rates from AEs , overall tolerability was good for both AN and PAE groups . CLINICAL TRIAL REGISTRATION Study of aripiprazole in the treatment of children and adolescents with autistic disorder . Registry : www . clinical trials.gov . Identifiers : NCT00332241 and NCT00337571 OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of acute quetiapine monotherapy in adolescents with schizophrenia . METHODS Patients ages 13 - 17 years with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . , Text Revision ( DSM-IV-TR ) diagnosis of schizophrenia and a Positive and Negative Syndrome Scale ( PANSS ) total score ≥60 were r and omized to 6 weeks of quetiapine ( 400 or 800 mg/day ) or placebo treatment . The primary efficacy measure was change in PANSS total score from baseline to day 42 . Safety endpoints included adverse events and assessment s of clinical chemistry values , suicidality , and extrapyramidal symptoms . RESULTS The intent-to-treat population included 220 patients . Least-squares mean change in PANSS total score from baseline to endpoint was -27.31 with quetiapine 400 mg/day , -28.44 with quetiapine 800 mg/day , and -19.15 with placebo ( p=0.043 and 0.009 for quetiapine 400 and 800 mg/day , respectively , vs. placebo ; mixed-model , repeated- measures analysis ) . Several secondary efficacy outcomes , including Clinical Global Impressions-Improvement score , supported the primary outcome measure in demonstrating significantly greater improvement in quetiapine groups than in the placebo group . Mean changes in body weight at day 42 were 2.2 kg and 1.8 kg for quetiapine 400 and 800 mg/day , respectively , and -0.4 kg for placebo . Mean changes in certain clinical chemistry parameters , including total cholesterol and triglycerides , were numerically greater in the quetiapine groups than in the placebo group . Adverse events associated with quetiapine were mostly mild to moderate in intensity and were consistent with its known profile in adults with schizophrenia . CONCLUSIONS In this 6-week study of adolescent patients , quetiapine at doses of 400 and 800 mg/day provided significant improvements in symptoms associated with schizophrenia in adolescent patients , including the primary efficacy measure of PANSS total score change . Quetiapine was generally well tolerated with a profile broadly similar to that reported in adult and adolescent population s. CLINICAL TRIAL REGISTRATION INFORMATION Quetiapine Fumarate ( SEROQUEL ( ™ ) ) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia ( ANCHOR 112 ) . Available at : http://www . clinical trials.gov/ct2/show/NCT00090324?term=quetiapine+112&rank=1 BACKGROUND Paliperidone extended-release ( ER ) is approved for treatment of schizophrenia in adults but has not been evaluated in adolescents . METHODS In this 6-week , double-blind , parallel-group study , participants ( n = 201 ) aged 12 to 17 years , with a Positive and Negative Syndrome Scale ( PANSS ) total score of 60 to 120 were r and omly allocated ( 1:1:1:1 ) to receive either placebo or one of three weight-based , fixed doses of paliperidone ER , once-daily ( patients weighing 29 to < 51 kg at baseline : 1.5 mg [ Low ] , 3 mg [ Medium ] , or 6 mg [ High ] ; patients weighing ≥ 51 kg : 1.5 mg [ Low ] , 6 mg [ Medium ] , or 12 mg [ High ] ) . RESULTS The mean ( SD ) change in PANSS total score from baseline to endpoint ( primary efficacy variable ) was significant for the paliperidone ER Medium-treatment ( -17.3 [ 14.33 ] ; p < .05 ; n = 54 ) but not for Low- ( -9.8 [ 16.31 ] ; n = 48 ) or High-treatment groups ( -13.8 [ 15.74 ] ; n = 47 ) versus placebo ( -7.9 [ 20.15 ] ; n = 51 ) . By actual dose , the mean ( SD ) change in PANSS total score was significant for the 3- , 6- , and 12-mg doses ( 3 mg : -19.0 [ 15.45 ] ) , 6 mg : -13.8 [ 14.75 ] , and 12 mg : -16.3 [ 15.41 ; ] all ps < .05 ) , compared with placebo ( -7.9 [ 20.15 ] ) . The total percentages of treatment-emergent adverse events were dose-related for the three weight-based treatment groups . CONCLUSIONS With weight-based treatment , only paliperidone ER Medium-treatment ( 3 - 6 mg ) result ed in significant improvement in symptoms of schizophrenia in adolescents , as did 3 , 6 , and 12 mg by actual dose strengths . Weight-based dosing of paliperidone ER in adolescents with schizophrenia does not appear to be necessary . Paliperidone ER ( 1.5 - 12 mg , once daily ) was tolerable , and no new safety concerns were reported BACKGROUND This study evaluates the long-term efficacy of aripiprazole compared to placebo in children with bipolar disorders . METHOD Out patients aged 4 to 9 years meeting DSM-IV criteria for a bipolar disorder ( I , II , not otherwise specified , cyclothymia ) were eligible to receive up to 16 weeks of open-label treatment with aripiprazole ( phase 1 ) . Patients were r and omized into the 72-week double-blind phase of the study once they met a priori response criteria for stabilization ( phase 2 ) . During phase 2 , patients either remained on their current aripiprazole regimen or began a double-blind taper with aripiprazole discontinued and switched to placebo . The primary outcome measure for phase 2 was time to discontinuation due to a mood event . RESULTS Patients were recruited between May 2004 and November 2008 . Following phase 1 , in which 96 patients received aripiprazole , 30 patients ( mean age = 7.1 years ) were r and omly assigned to continue aripiprazole and 30 patients ( mean age = 6.7 years ) were r and omly assigned to placebo . The mean ( SD ) dose of aripiprazole prior to r and omization for these patients was 6.4 ( 2.1 ) mg/d . Patients r and omly assigned to aripiprazole were enrolled significantly longer until time to study discontinuation due to a mood event ( 6.14 median weeks , SE ± 11.88 weeks ; P = .005 ) and discontinuation for any reason ( including mood events ) ( 4.00 median weeks , SE ± 3.91 weeks ; P = .003 ) than those r and omly assigned to placebo ( mood event , 2.29 median weeks , SE ± 0.38 weeks ; any reason , 2.00 median weeks , SE ± 0.31 weeks ) . Regardless of r and om assignment , both the aripiprazole and placebo groups showed substantial rates of withdrawal from maintenance treatment over the initial 4 weeks ( 15/30 [ 50 % ] for aripiprazole ; 27/30 [ 90 % ] for placebo ) , suggesting a possible nocebo effect ( ie , knowledge of possibly switching from active medication to placebo increasing concern about relapse ) . The most frequently reported adverse events during double-blind aripiprazole therapy included stomach pain ( n = 10 , 33 % ) , increased appetite ( n = 9 , 30 % ) , and headaches ( n = 9 , 30 % ) . CONCLUSIONS Despite the possibility of a nocebo effect , these results suggest that aripiprazole may be superior to placebo in the long-term treatment of pediatric patients following stabilization with open-label aripiprazole . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00194077 BACKGROUND & AIMS Weight gain is an undesirable side effect of second-generation antipsychotics ( SGAs ) . We performed this study to examine the influence of SGAs on resting energy expenditure ( REE ) and the relationship of REE to weight gain in adolescent patients . METHODS Antipsychotic-naïve or quasi-naïve ( < 72 h of exposure to antips \n Output:\n " }, { "from": "agent", "value": "FGAs caused slightly less weight gain and more extrapyramidal symptoms than SGAs .\nSGAs as a class caused adverse effects , including weight gain , high triglyceride levels , extrapyramidal symptoms , sedation , and somnolence .\nThey appeared to increase the risk for high cholesterol levels and type 2 diabetes .\nOlanzapine caused more short-term gains in weight and body mass index than several other SGAs .\nThe dose of SGAs may not make a difference over the short term for some outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In a double-blind , r and omized , multicentre clinical study , the efficacy and tolerance of a herbal medicine product , Harpadol ( 6 capsules/day , each containing 435 mg of powdered cryoground powder Harpagophytum procumbens ) , was compared with diacerhein 100 mg/day in the treatment , for 4 months , of 122 patients suffering from osteoarthritis of the knee and hip . Assessment s of pain and functional disability were made on a 10 cm horizontal visual analogue scale ; severity of osteoarthritis was evaluated by Lequesne 's index . Spontaneous pain showed a significant improvement during the course of the study and there was no difference in the efficacy of the two treatments . Similarly , there was a progressive and significant reduction in the Lequesne functional index and no statistical difference was found between Harpadol and diacerhein . At completion of the study , patients taking Harpadol were using significantly less NSAIDs and antalgic drugs . The frequency of adverse events was significantly lower in the Harpadol group . The most frequent event reported was diarrhea , occurring in 8.1 % and 26.7 % of Harpadol and diacerhein patients respectively . The global tolerance assessment by patients at the end of treatment favoured Harpadol . The results of this study demonstrate that Harpadol is comparable in efficacy and superior in safety to diacerhein OBJECTIVE To examine the rates of use and expenditures on alternative therapies by adults with osteoarthritis ( OA ) . METHODS Adults with OA recruited from the community to participate in a r and omized clinical trial recorded alternative and traditional health care use on postcard diaries . General and arthritis-specific quality of life was assessed by question naires . RESULTS More than 47 % of participants reported using at least one type of alternative care during the 20-week intervention period . Among alternative care consumers , the most commonly used treatments were massage therapy ( 57 % ) , chiropractic services ( 20.7 % ) , and nonprescribed alternative medications ( 17.2 % ) . Four percent of subjects reported using only alternative care during the study period . Expenditures for alternative therapy averaged $ 1,127 per year , compared with $ 1,148 for traditional therapies . CONCLUSION Use of and expenditures for alternative care were high among this cohort of older adults with OA . Clinicians may want to inquire about use of these therapies before recommending treatments for this condition Background This study was design ed to determine if a natural mineral supplement , sierrasil , alone and in combination with a cat 's claw extract ( Uncaria guianensis ) , vincaria , has therapeutic potential in mild to moderate osteoarthritis of the knee . Methods Patients ( n = 107 ) with mild to moderate osteoarthritis of the knee were r and omly assigned to one of 4 groups ; high dose sierrasil ( 3 g/day ) , low dose sierrasil ( 2 g/day ) , low dose sierrasil ( 2 g/day ) + cat 's claw extract ( 100 mg/day ) or placebo , administered for 8 weeks . Treatment was double blinded . Primary efficacy variables were WOMAC scores ( A , B , C and total ) . Visual analog score ( VAS ) for pain , consumption of rescue medication ( paracetamol ) , and tolerability were secondary variables . Safety measures included vital signs and laboratory-based assays . Results Ninety-one of the 107 patients successfully completed the protocol . All four groups showed improvement in WOMAC and VAS scores after 8 weeks ( p < 0.001 ) , in all 3 groups receiving sierrasil the magnitude of benefits were greater vs. placebo ( WOMAC Total 38–43 % vs. 27 % ) but this was not statistically significant . In reference to baseline values sierrasil treated groups had a considerably faster onset of benefits . Placebo-treated individuals failed to show significant benefits at 4 weeks ( 11 % reduction in total WOMAC ) . In contrast , after 1 or 2 weeks of therapy all the sierrasil groups displayed significant reductions in WOMAC scores ( p < 0.05 ) and at week 4 displayed a 38–43 % improvement . VAS was significantly improved at 4 weeks in all groups ( p < 0.001 ) but was significantly greater in all sierrasil groups compared to placebo ( p < 0.05 ) . Rescue medication use was 28 - 23 % lower in the herbomineral combination and high dose sierrasil groups although not statistically different from placebo ( P = 0.101 and P = 0.193 , respectively ) . Tolerability was good for all groups , no serious adverse events were noted and safety parameters remained unchanged . Conclusion The natural mineral supplement , sierrasil alone and in combination with a cat 's claw extract , improved joint health and function within 1–2 weeks of treatment but significant benefits over placebo were not sustained , possibly due to rescue medication masking . Sierrasil may offer an alternative therapy in subjects with joint pain and dysfunction Objective To evaluate the effect of niacinamide , on selected parameters of osteoarthritis using a doubleblind , placebo controlled study design . Methods Seventy two patients with osteoarthritis were r and omized for treatment with niacinamide or an identical placebo for 12 weeks . Outcome measures included global arthritis impact and pain , joint range of motion and flexibility , erythrocyte sedimentation rate , complete blood count , liver function tests , cholesterol , uric acid , and fasting blood sugar . Compliance was monitored with a pill record sheet and interview . Results Global arthritis impact improved by 29 % ( 95 % confidence interval [ CI ] 6 , 46 ) in subjects on niacinamide and worsened by 10 % in placebo subjects ( p=0.04 ) . Pain levels did not change but those on niacinamide reduced their anti-inflammatory medications by 13 % ( 95 % CI 9 , 94 ; p=0.01 ) . Niacinamide reduced erythrocyte sedimentation rate by 22 % ( 95 % CI 6 , 51 ; p<0.005 ) and increased joint mobility by 4.5 degrees over controls ( 8 degrees vs. 3.5 degrees ; p=0.04 ) . Side effects were mild but higher in the niacinamide group ( 40 % vs 27 % , p=0.003 ) . Conclusion This study indicates that niacinamide may have a role in the treatment of osteoarthritis . Niacinamide improved the global impact of osteoarthritis , improved joint flexibility , reduced inflammation , and allowed for reduction in st and ard anti-inflammatory medications when compared to placebo . More extensive evaluation of niacinamide in arthritis is warranted OBJECTIVE Osteoarthritis ( OA ) is the most common form of arthritis and the second most common cause of long-term disability among middle-aged and older adults in the United States . Methylsulfonylmethane ( MSM ) is a popular dietary supplement used as a single agent and in combination with other nutrients , and purported to be beneficial for arthritis . However , there is paucity of evidence to support the use of MSM . METHODS A r and omized , double-blind , placebo-controlled trial was conducted . Fifty men and women , 40 - 76 years of age with knee OA pain were enrolled in an outpatient medical center . Intervention was MSM 3 g or placebo twice a day for 12 weeks ( 6g/day total ) . Outcomes included the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale ( WOMAC ) , patient and physician global assessment s ( disease status , response to therapy ) , and SF-36 ( overall health-related quality of life ) . RESULTS Compared to placebo , MSM produced significant decreases in WOMAC pain and physical function impairment ( P<0.05 ) . No notable changes were found in WOMAC stiffness and aggregated total symptoms scores . MSM also produced improvement in performing activities of daily living when compared to placebo on the SF-36 evaluation ( P<0.05 ) . CONCLUSION MSM ( 3 g twice a day ) improved symptoms of pain and physical function during the short intervention without major adverse events . The benefits and safety of MSM in managing OA and long-term use can not be confirmed from this pilot trial , but its potential clinical application is examined . Underlying mechanisms of action and need for further investigation of MSM are discussed OBJECTIVE To determine the benefit of cetylated fatty acids ( CFA ) on knee range of motion and function in patients with osteoarthritis ( OA ) . METHODS Sixty-four patients with chronic knee OA were evaluated at baseline and at 30 and 68 days after consuming either placebo ( vegetable oil ; n = 31 ) or CFA ( Celadrin ; n = 33 ) . Evaluations included physician assessment , knee range of motion with goniometry , and the Lequesne Algofunctional Index ( LAI ) . RESULTS After 68 days , patients treated with CFA exhibited significant ( p < 0.001 ) increase in knee flexion ( 10.1 degrees ) compared to patients given placebo ( 1.1 degrees ) . Neither group reported improvement in knee extension . Patient responses to the LAI indicated a significant ( p < 0.001 ) shift towards functional improvement for the CFA group ( -5.4 points ) after 68 days compared to a modest improvement in the placebo group ( -2.1 points ) . CONCLUSION Compared to placebo , CFA provides an improvement in knee range of motion and overall function in patients with OA of the knee . CFA may be an alternative to the use of nonsteroidal antiinflammatory drugs for the treatment of OA BACKGROUND A st and ardized rose-hip powder produced from the seeds and husks of fruit from a subtype of Rosa canina has been reported to inhibit leukocyte functions that cause cell injury in osteoarthritis . OBJECTIVE The aim of this study was to assess the impact of st and ardized rose-hip powder on mobility of the hip and knee joints , activities of daily living , quality of life , and pain in patients with osteoarthritis . METHODS Patients with a diagnosis of osteoarthritis of either the hip or knee , verified on radiography , participated in this r and omized , placebo-controlled , double-blind study . Half of the patients were given five 0.5-g capsules of st and ardized rose-hip powder twice daily for 4 months , and the other half received identical placebo capsules twice daily for the same period . Mobility of the hip or knee was measured in both groups after the initial screening and again after 4 months of therapy . RESULTS One hundred patients ( 65 women , 35 men ; mean [ SD ] age , 65.2 [ 11.1 ] years ) were divided into 2 treatment groups of 50 patients each . Hip joint mobility improved significantly in the treatment group compared with the placebo group ( P = 0.033 ) . Similarly , pain decreased significantly in the treatment group compared with the placebo group ( P = 0.035 ) . Two patients ( 4 % ) from each group withdrew during the early stages of the trial for reasons not related to treatment . CONCLUSIONS In this study population , st and ardized rose-hip powder reduced symptoms of osteoarthritis , as 64.6 % of patients reported at least some reduction of pain while receiving treatment . St and ardized rose-hip powder may improve hip flexion and reduce pain in patients with osteoarthritis OBJECTIVE Evaluation of the effect of a ginger extract ( Zintona EC ) on patients suffering from gonarthritis . MATERIAL AND METHODS Twenty-nine patients ( 6 men and 23 women ) with symptomatic gonarthritis ( ACR criteria ) , in the age range 42 - 85 years , were included after r and omization in a double blind , placebo controlled , crossover study of 6 months ' duration . The treatment group was given a ginger extract ( 250 mg of Zingiberis Rhizoma per capsule , qid ) , while the placebo group received the same number of identical looking capsules per day . The crossover occurred after 3 months of therapy . Results were evaluated by a 100 mm visual analog scale ( VAS ) of pain on movement and of h and icap . RESULTS Eight patients dropped out because of inefficacy , three from group 1 ( ginger extract first ) and five from group 2 ( placebo first ) . One patient from group 1 and one from group 2 dropped out because of heartburn ( while they were on ginger extract ) . Twenty patients completed the study period of 24 weeks and 19 that of 48 weeks follow-up . By the end of 24 weeks there was a highly statistically significant difference between the VAS of pain and h and icap of the two groups ( P<0.001 ) . However , at crossover both groups showed a statistically significant decrease in VAS of pain on movement and of h and icap , but the differences between the groups did not reach statistical significance . CONCLUSIONS Zintona EC was as effective as placebo during the first 3 months of the study , but at the end of 6 months , 3 months after crossover , the ginger extract group showed a significant superiority over the placebo group INTRODUCTION Although vitamin C is essential for the formation of collagen and proteoglycan and has been shown to minimise surgically induced arthritis in guinea pigs , no controlled trial has examined its effect on human osteoarthritis . MATERIAL AND METHODS The trial was a multicenter , double-blind , r and omised , placebo-controlled , crossover-trial performed by ten general practitioners . The Dec \n Output:\n " }, { "from": "agent", "value": "Moderate evidence was found for methylsulfonylmethane and SKI306X , a cocktail of plant extracts .\nOverall , scientific evidence exists for some specific nutritional interventions to provide symptom relief to osteoarthritic patients .\nIt remains to be investigated whether nutritional compounds can have structure-modifying effects" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To investigate stroke patients ’ and carers ’ perceptions of the family support organizer ( FSO ) service in order to highlight its value for potential purchasers and to help shed light on findings from r and omized controlled trials . Design and subjects : Twenty semi-structured interviews were undertaken with a sub sample of stroke patients and their primary informal carers after completion of nine-month outcome assessment s as part of a r and omized controlled trial . Setting : Community stroke services in North Nottinghamshire , UK . Results : Interviewees who received the service reported that the presence of an FSO was valuable in many respects , including helping to cl aim benefits , as a source of information on stroke , and providing continuity between stroke services . Emotional support was only described by a few . Interviewees who did not receive the service described feelings of isolation and being let down by other stroke services after discharge . They also reported problems accessing information . Help needed to address the practical problems after stroke was commonly reported . For those who did not receive the FSO service , access to support appeared to be found through other channels . Conclusion : The FSO service appeared to be an information service . In order to evaluate community stroke services , a mixture of qualitative and quantitative outcome measures are necessary Objectives : To perform a process evaluation of a r and omized controlled trial ( RCT ) of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease ( COPD ) , using the normalization process model ( NPM ) as an explanatory framework . Methods : Semi-structured interviews were carried out with patients ( n = 9 ) and nurses ( n = 11 ) participating in a RCT . A framework approach to data analysis was used . Results : The telecare service did not provide an interactional advantage for the nurses providing this service and did not fit with the nurses ' views of the most appropriate or preferred use of their skills . The telecare service seemed unlikely to become normalized as part of routine healthcare delivery , because the nursing team lacked confidence that it was a safe way to provide healthcare in this context and it was not perceived as improving efficiency . Discussion : The NPM effectively mapped onto the study findings and explained those factors that inhibited the routine delivery of COPD services by telecare \n Output:\n " }, { "from": "agent", "value": "RESULTS Three core themes emerged from the analysis : patients ' health beliefs affect their participation in SCBC interventions ; patients ' experiences with community-based care differ from their experiences with hospital-based care ; patients and providers value the role of nurses differently in community-based chronic disease care .\nPatients with chronic diseases who participated in SCBC interventions reported greater satisfaction when SCBC helped them better underst and their diagnosis , facilitated increased socialization , provided them with a role in managing their own care , and assisted them in overcoming psychological and social barriers .\nThree themes came up in our analysis : patients ' health beliefs affect how they take part in SCBC interventions ; patients ' experiences with care in the community differ from their experiences with care in the hospital ; patients and providers value the role of nurses differently .\nThe results of this analysis could help those who provide SCBC programs to better meet patients ' needs" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Summary In a biopharmaceutical study of carbamazepine , the F-CBZ , DAK preparation , which contained small particles with minor variation in size , had a more rapid dissolution rate than Tegretol , which contained larger particles of more variable size . Accordingly , carbamazepine had a more rapid absorption rate from F-CBZ , DAK than from Tegretol in a comparative absorption test involving single-dose administration of 200 mg to 8 healthy volunteers . The clinical significance of the difference in absorption rates for the steady state levels of carbamazepine and carbamazepine-10,11-epoxide , and the frequency of side-effects in relation to tablet intake , were evaluated in a double-blind , r and omized , double-dummy cross-over trial of 35 days ' duration , in 21 well-adjusted epileptic patients . 9 patients were treated with Tegretol alone and 12 with Tegretol combined with other antiepileptic drugs . A lower steady state plasma level of carbamazepine was found at 08.00 h during treatment with F-CBZ , DAK in comparison with Tegretol . The difference was small . There was no difference in the type and frequency of side-effects or seizures between the 2 preparations . The frequency of epileptic fits was not correlated with the plasma level of carbamazepine or the epoxide . Side-effects , however , had a tendency to be correlated with the concentration of the epoxide . Thus , the particle size influenced the absorption rate of carbamazepine , without having a significant correlation with the frequency of side-effects . The difference in the minimum plasma level of carbamazepine between treatments with the two preparations was modest , and appeared to be without clinical significance We evaluated the use of a new , controlled-release capsule form of carbamazepine , Carbatrol capsules , in an open-label , multicenter study of 124 patients with complex partial seizures . Ninety-one percent of the patients successfully completed the 6-month trial with good seizure control , with a significant improvement in quality of life . We conclude that switching patients with complex partial seizures from multiple daily-dose carbamazepine to twice-daily Carbatrol on a milligram-to-milligram basis is relatively safe Carbatrol ( CBR ) is a new multiple-unit , sustained-release dosage form of carbamazepine ( CBZ ) developed by Pharmavene . We present a multicenter , outpatient , r and omized , double-blind parallel group study ( No PI 101 ) carried out in two centers in Pol and . CBR was evaluated in 47 patients with uncontrolled partial onset seizures . During the 28-day baseline period , patients were required to have at least two seizures and to take CBZ at a therapeutic level , a second antiepileptic drug was allowed but not valproic acid ( VPA ) . Patients were r and omized to VPA or to CBR ( dosages 800 , 1200 , 1600 mg/day ) . Criteria for escape relative to baseline were : two-fold increase in monthly seizure frequency , two-fold increase in 2-day seizure frequency , two-fold increase in weekly seizure frequency , single generalized tonic-clonic seizure ( GTCs ) if none occurred during baseline or prolongation of GTCs . The primary efficacy variable was the number of patients escaping in each treatment group . Nineteen patients on VPA and 7 on CBR met escape criteria . CBR adverse experiences were all mild or moderate in severity . CBR therapy was effective in the treatment of partial complex seizures with or without generalization To compare the effects on attention and vigilance of conventional carbamazepine ( CBZ ) and CBZ controlled release ( CBZ-CR ) , 15 schoolchildren with epilepsy and normal intelligence receiving CBZ were switched to CBZ-CR . Psychological examination was performed on the day before ( day A ) and 1 month after substitution ( day B ) . Measurements of attention and vigilance were repeated throughout the day at 2-h intervals . Both on days A and B , CBZ plasma levels were monitored during a 12-h period . Fifteen matched healthy controls were su bmi tted to identical test programs , allowing comparisons within subjects as well as between patients and control children . Variability of performance over sessions was neither increased nor decreased with CBZ-CR . Consistent differences over sessions did not exist between patients and controls with either drug . No relation was noted between reaction time and CBZ plasma level . The pharmacologic data confirm results of earlier studies in children . We noted a reduction in intradose fluctuations of CBZ level with CBZ-CR as compared with conventional CBZ . The neuropsychological results do not show a difference between the drugs . Neither were differences noted with respect to antiepileptic efficacy and side effects . At the end of the study , all but one of the children ( and their parents ) opted to receive CBZ-CR for ease of dosage administration and overall satisfaction Pharmacokinetic properties and efficacy of a conventional ( C ) carbamazepine ( CBZ ) preparation divided into three daily doses and a slow-release CBZ preparation ( SR ) divided into two daily doses were evaluated in a r and omized , double-blind , cross-over study . The trial started with a 8-week baseline period followed by the two treatment periods each 10 weeks long . At the end of each period , a 24-h blood sample series for determination of serum CBZ and carbamazepine-10,11-epoxide ( CBZE ) was collected . The occurrence of seizures was monitored day and night during the whole study period by experienced nurses . The mean age of the 20 evaluable patients was 24.9 and the duration of epilepsy 19.2 and carbamazepine treatment 7.0 years . The bioavailability of CBZ from the two preparations was similar . The mean fluctuation of serum CBZ concentration ( Cmax-Cmin/Css ) was 16 % smaller during SR . The mean serum CBZ concentration in the morning sample s was significantly ( P less than 0.001 ) higher during SR treatment . The mean total number of seizures was approximately four per week and did not differ between the two treatments , but during the last 2 weeks of the study period the occurrence of seizures was significantly smaller during SR ( P = 0.02 ) A multicentre open therapeutic trial comparing carbamazepine with slow-release carbamazepine was conducted in 114 epileptic patients older than 12 years . The patients received the two products successively during two periods of 1 month each . With slow-release carbamazepine the number of doses could be reduced to 2 per day without decrease in effectiveness and with less side-effects . The twice-a-day dosage should result in better compliance and consequently in a better quality of treatment in the long term The treatment of epilepsy with carbamazepine ( CBZ ) may be hampered by cognitive side effects . These side effects are thought to be related to pharmacokinetic properties of the drug . The serum concentration of CBZ is characterized by rapid absorption and a short half-life , which may lead to a considerable fluctuation of the level between doses . Cognitive defects may result from peak levels : short periods with high serum concentration . In a single-blind crossover design , cognitive performance was compared in three conditions . All patients were first tested in the steady state of conventional CBZ . The patients were then assigned r and omly to either CBZ-controlled release ( CR ) or a condition in which conventional CBZ was administered in the same tablet form and dose frequency as CR . Psychological tests were administered four times daily , immediately after the serum sample s were taken . A nonmedication control group was tested following the same test scheme to obtain st and ards for the evaluation of changes in performance during the day . A systematic tendency was found toward higher test performance in the CR condition . This is especially evident for tests of memory and accuracy of visual information processing . The results of the repeated test procedure show that the smoothing effect of the CR condition on serum concentration fluctuations results in a more stable pattern of cognitive functioning during the day PURPOSE A new capsule dosage form of carbamazepine ( CBZ ) has been developed , consisting of three different types of beads ( immediate-release , extended-release , and enteric-release ) that may be taken sprinkled on food or swallowed for easy administration . We compared the pharmacokinetics of the extended-release dosage form of CBZ ( Carbatrol capsules ) twice daily with the conventional immediate-release formulation of CBZ four times daily . METHODS The r and omized , double-blind , two-way , cross-over study was conducted at two sites , with a planned sample size of 24 adult patients with epilepsy . Each treatment was administered for 2 weeks . At the end of the 2-week period , blood sample s were obtained hourly for a 24-h period . RESULTS The 90 % confidence intervals ( CI ) of the ratio of the means of the extended-release formulation twice daily to the immediate-release formulation four times daily were within the range of 0.80 - 1.25 for each of the pharmacokinetic parameters for CBZ and for the summation of CBZ and CBZ-epoxide ( CBZ-E ) . There was no difference in the frequency of seizures between treatment ( p = 0.103 ) . CONCLUSIONS Our results demonstrate that extended-release CBZ twice daily was bioequivalent to immediate-release CBZ four times daily , with regard to CBZ levels and summation of CBZ and CBZ-E levels , based on the pharmacokinetic parameters evaluated . Substituting one formulation for the other did not cause patients to have a significant change in seizure frequency Abstract The tolerability and pharmacokinetics of a new controlled‐release ( CR ) formulation of carbamazepine ( CBZ ) , were assessed in a multicentre , double‐blind , cross‐over trial , carried out in 48 epileptic patients ( 21 men , 27 women ; mean age 34.2 years ) on conventional CBZ monotherapy , but without complete seizure control ( n = 22 ) or with intermittent side effects ( n = 4 ) , or with both ( n = 22 ) . Eligible patients were r and omized to conventional CBZ or CR CBZ , each given in sequence at individualized daily doses , subdivided into the lowest number of administrations . Each period of the cross‐over consisted of a first phase of optimal dose finding ( lasting up to two months ) and a second one of maintenance ( lasting one month ) used for evaluation . At the end of each period , a 10‐h plasma CBZ and CBZ‐epoxide concentration profile , as well as the tolerability and the efficacy of the drugs , were evaluated . The mean CBZ daily dose increased by 16 % during the administration of the CR formulation . Fluctuations of total CBZ and 10 , 11‐epoxide plasma level daily profiles at steady‐state were significantly ( p < 0.001 ) lower during CR CBZ treatment , leading to a significant ( p < 0.001 ) decrease in intermittent side effects ( 6 patients on CR CBZ vs 26 on conventional CBZ ) . Finally , 38 patients on CR CBZ ( vs 15 patients on conventional CBZ ) were treated with a b.i.d . regimen A 2-week open \n Output:\n " }, { "from": "agent", "value": "At present , data from trials do not confirm or refute an advantage for CR CBZ over IR CBZ for seizure frequency or adverse events in patients with newly diagnosed epilepsy .\nFor trials involving epilepsy patients already prescribed IR CBZ , no conclusions can be drawn concerning the superiority of CR CBZ with respect to seizure frequency .\nThere is a trend for CR CBZ to be associated with fewer adverse events when compared to IR CBZ .\nA change to CR CBZ may therefore be a worthwhile strategy in patients with acceptable seizure control on IR CBZ but experiencing unacceptable adverse events ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction Unscheduled hospital admissions are an increasing burden on health systems worldwide . To date , initiatives to reduce admissions have had limited success as it is unclear which strategies effectively reduce admissions and are supported by a strong evidence -base . Therefore , we will conduct an overview to find , assess and summarise all published peer- review ed systematic review s of r and omised controlled trials that examine the effect of an intervention on unplanned admissions among adults . Methods and analysis This is a protocol for a systematic overview of review s. We will search four data bases : Ovid MEDLINE , PubMed , Cochrane Data base of Systematic Review s and the Cochrane Data base of Abstract s of Review s of Effects . We will consider systematic review s and meta-analyses of r and omised controlled trials in adults ( ≥16 years old ) evaluating the effect of any intervention on unscheduled hospital admissions including those to treat , monitor , diagnose or prevent a health problem . We will only include review s that identified unscheduled hospitalisations as a prespecified outcome . Two authors will independently screen articles for inclusion using a priori criteria . We will assess the quality of included review s and extract ratings of the quality of evidence from within each review . We will create a hierarchical list of interventions based on estimates of absolute admission reductions and the quality of the evidence . Presentation of results will align with guidelines in the Cochrane H and book of Systematic Review s of Interventions and the Preferred Reporting Items for Systematic Review s and Meta- Analysis statement . Ethics and dissemination Ethics approval is not required . We will su bmi t the results of this study for peer- review publication . The results will inform future research and could be used by healthcare managers , administrators and policymakers to guide re source allocation decisions and inform local implementation and optimisation of interventions to reduce unscheduled hospital admissions BACKGROUND Echinacea is widely used to treat the common cold . OBJECTIVE To assess the potential benefits of echinacea as a treatment of common cold . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00065715 ) SETTING Dane County , Wisconsin . PATIENTS 719 patients , aged 12 to 80 years , with new-onset common cold . INTERVENTION Patients were assigned to 1 of 4 parallel groups : no pills , placebo pills ( blinded ) , echinacea pills ( blinded ) , or echinacea pills ( unblinded , open-label ) . Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days . Indistinguishable placebo tablets contained only inert ingredients . MEASUREMENTS The primary outcome was the area under the curve for global severity , with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey , short version . Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash , assessed at intake and 2 days later . RESULTS Of the 719 patients enrolled , 713 completed the protocol . Mean age was 33.7 years , 64 % were female , and 88 % were white . Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups , respectively ; 264 for the blinded placebo group ; and 286 for the no-pill group . A comparison of the 2 blinded groups showed a 28-point trend ( 95 % CI , -69 to 13 points ) toward benefit for echinacea ( P = 0.089 ) . Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days , respectively , compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group . A comparison of the blinded groups showed a nonsignificant 0.53-day ( CI , -1.25 to 0.19 days ) benefit ( P = 0.075 ) . Median change in interleukin-8 levels and neutrophil counts were also not statistically significant ( 30 ng/L and 1 cell/high-power field [ hpf ] in the no-pill group , 39 ng/L and 1 cell/hpf in the blinded placebo group , 58 ng/L and 2 cells/hpf in the blinded echinacea group , and 70 ng/L and 1 cell/hpf in the open-label echinacea group ) . LIMITATION Higher-than-expected variability limited power to detect small benefits . CONCLUSION Illness duration and severity were not statistically significant with echinacea compared with placebo . These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold . PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine , National Institutes of Health CONTEXT Patients with cancer undergoing similar treatments experience variable severity and frequency of side effects not adequately explained by pharmacological mechanisms , suggesting psychological influence . OBJECTIVES First , this study aim ed to further examine the relationship between patients ' expectations of multiple chemotherapy-related toxicities and experiences . Second , this study aim ed to explore the impact of anxiety and cancer coping styles to aid in informing interventions to lessen such expectations . METHODS A total of 59 eligible , consenting patients with cancer rated their expectations of 20 chemotherapy toxicities on 100-point linear analogue self- assessment indicators before treatment and completed the Spielberger State Anxiety Inventory and the Mental Adjustment to Cancer scale . Patients then rated their experience of side effects after one chemotherapy session . RESULTS Regressions controlling primary treating nurse influence and patient performance status showed toxicity experience was significantly predicted by patient expectations of mood changes , bleeding , skin itchiness , hair loss , feeling tired , and sleep disturbance ( β=0.30 - 0.55 ) . Anxiety was significantly related to expectations of nervousness and mood changes ; the coping style Fighting Spirit showed no significant associations , whereas conversely , Anxious Preoccupation showed some degree of association with all 20 toxicities ( r=0.11 - 0.34 ) . CONCLUSION Findings support the growing contention that patient expectations influence experience , negatively impacting quality of life . As it is unethical to withhold treatment information , research into screening for at-risk patients and offering brief interventions to minimize Anxious Preoccupation could be one way to reduce overall side effect burden , perhaps in the case of many medical interventions A year ago BMJ Publications released a 350 page tome that many people will regard as the last word on informed consent to treatment.1 What is missing from this otherwise comprehensive compendium is a practical guide for clinicians at the coalface . In an effort to overcome this deficit we have generated a menu of alternative styles of informed consent . The first five options relate to consent for treatment within r and omised controlled trials , and the final six are options for use in routine clinical practice . We are confident that our menu will help frontline clinicians and patients in practice . It may also help medical ethicists in theory . # # # # Summary points Many alternative styles of informed consent to treatment exist , along with much theory , a few principles , and different st and ards of consent within and outside r and omised trials , but concise practical advice about the available alternatives is not readily accessible We have assembled a menu of options to help frontline clinicians and patients to select whichever form of consent meets their particular needs and circumstances # # # Human sacrifice r and omised controlled trial consent “ The research ethics committee that approved this trial on your behalf would like you to know that future generations might ( or might not ) appreciate it if you would put your life at risk by joining this trial . Although we will keep your individual trial results confidential ( especially if they run contrary to our hypothesis ) and you are free to insist on conventional treatment or withdraw at any time , let 's face it — you are a human guinea pig . The investigators responsible for the study may have conducted a systematic review of relevant previous studies to see whether one of the alternative treatments has already been shown to be superior , but this sort of evidence is beyond the interest and competency of our local research ethics committee , which is primarily interested in protecting \n Output:\n " }, { "from": "agent", "value": "Conclusions and implication s of key findings AEs in trial placebo groups are common and can not be attributed entirely to natural history ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Context : Denosumab 60 mg sc injection every 6 months for 36 months was well tolerated and effective in reducing the incidence of vertebral , nonvertebral , and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis . Objective : The objective of this phase 3 fracture study was to examine the antifracture efficacy and safety of denosumab 60 mg in Japanese women and men with osteoporosis compared with placebo . Design and Setting : A r and omized , double-blind , placebo-controlled trial with an open-label active comparator as a referential arm was conducted . Patients : Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older , who had one to four prevalent vertebral fractures . Intervention : Subjects were r and omly assigned to receive denosumab 60 mg sc every 6 months ( n = 500 ) , placebo for denosumab ( n = 511 ) , or oral alendronate 35 mg weekly ( n = 251 ) . All subjects received daily supplements of calcium and vitamin D. Main Outcome Measure : The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo . Results : Denosumab significantly reduced the risk of new or worsening vertebral fracture by 65.7 % , with incidences of 3.6 % in denosumab and 10.3 % in placebo at 24 months ( hazard ratio 0.343 ; 95 % confidence interval 0.194–0.606 , P = .0001 ) . No apparent difference in adverse events was found between denosumab and placebo during the first 24 months of the study . Conclusion : These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis CONTEXT Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-kappaB lig and , a mediator of osteoclastogenesis and osteoclast survival . OBJECTIVE This study evaluated the ability of denosumab to increase bone mineral density ( BMD ) and decrease bone turnover markers ( BTMs ) in early and later postmenopausal women with low BMD . DESIGN AND SETTING This 2-yr r and omized , double-blind , placebo-controlled study was conducted in North America . PARTICIPANTS Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between -1.0 and -2.5 . INTERVENTIONS SUBJECTS were r and omly assigned to receive denosumab sc , 60 mg every 6 months , or placebo . R and omization was stratified by time since onset of menopause ( < or = 5 yr or > 5 yr ) . MAIN OUTCOME MEASURES The primary end point was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry at 24 months . Additional end points were percent change in volumetric BMD of the distal radius by quantitative computed tomography ; percent change in BMD by dual-energy x-ray absorptiometry for the total hip , one-third radius , and total body ; hip structural analysis ; percent change in BTMs ; and safety . RESULTS Denosumab significantly increased lumbar spine BMD , compared with placebo at 24 months ( 6.5 vs. -0.6 % ; P<0.0001 ) with similar results for both strata . Denosumab also produced significant increases in BMD at the total hip , one-third radius , and total body ( P < 0.0001 vs. placebo ) ; increased distal radius volumetric BMD ( P < 0.01 ) ; improved hip structural analysis parameters ; and significantly suppressed serum C-telopeptide , tartrate-resistant acid phosphatase-5b , and intact N-terminal propeptide of type 1 procollagen . The overall incidence of adverse events was similar between both study groups . CONCLUSIONS Twice-yearly denosumab increased BMD and decreased BTMs in early and later postmenopausal women CONTEXT For many patients , adhering to postmenopausal osteoporosis treatment is a challenge . Higher treatment satisfaction is associated with greater persistence with these therapies , which is associated with better outcomes . OBJECTIVE This study aim ed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate . DESIGN AND SETTING Pooled data of out patients from two international , multicenter , r and omized , open-label studies were analyzed . PATIENTS Postmenopausal women ( n = 1703 ) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy , as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale , were included in the study . INTERVENTIONS Patients received denosumab , a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B lig and , 60 mg s.c . every 6 months vs the oral bisphosphonates ib and ronate or risedronate , 150 mg once monthly for 12 months . MAIN OUTCOME MEASURES Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Question naire for Medication ( TSQM ) . The TSQM is a vali date d tool that measures perception of four domains of treatment satisfaction : effectiveness , side effects , convenience , and global satisfaction . RESULTS Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months . However , the denosumab group had significantly ( all P < .001 ) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group . CONCLUSIONS Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate INTRODUCTION Denosumab is a fully human monoclonal antibody that inhibits receptor activator of nuclear factor-kappa B lig and ( RANKL ) , an essential mediator of osteoclast formation , function , and survival that has been shown to decrease bone turnover and increase bone mineral density ( BMD ) in treated patients . We assessed the long-term efficacy and safety of denosumab , and the effects of discontinuing and restarting denosumab treatment in postmenopausal women with low bone mass . METHODS Postmenopausal women with a lumbar spine T-score of -1.8 to -4.0 or proximal femur T-score of -1.8 to -3.5 were r and omized to denosumab every 3 months ( Q3 M ; 6 , 14 , or 30 mg ) or every 6 months ( Q6 M ; 14 , 60 , 100 , or 210 mg ) ; placebo ; or open-label oral alendronate weekly . After 24 months , patients receiving denosumab either continued treatment at 60 mg Q6 M for an additional 24 months , discontinued therapy , or discontinued treatment for 12 months then re-initiated denosumab ( 60 mg Q6 M ) for 12 months . The placebo cohort was maintained . Alendronate-treated patients discontinued alendronate and were followed . Changes in BMD and bone turnover markers ( BTM ) as well as safety outcomes were evaluated . RESULTS Overall , 262/412 ( 64 % ) patients completed 48 months of study . Continuous , long-term denosumab treatment increased BMD at the lumbar spine ( 9.4 % to 11.8 % ) and total hip ( 4.0 % to 6.1 % ) . BTM were consistently suppressed over 48 months . Discontinuation of denosumab was associated with a BMD decrease of 6.6 % at the lumbar spine and 5.3 % at the total hip within the first 12 months of treatment discontinuation . Retreatment with denosumab increased lumbar spine BMD by 9.0 % from original baseline values . Levels of BTM increased upon discontinuation and decreased with retreatment . Adverse event rates were similar among treatment groups . CONCLUSIONS In postmenopausal women with low BMD , long-term denosumab treatment led to gains in BMD and reduction of BTM throughout the course of the study . The effects on bone turnover were fully reversible with discontinuation and restored with subsequent retreatment OBJECTIVE : To compare the efficacy and safety of denosumab to ib and ronate in postmenopausal women with low bone mineral density ( BMD ) previously treated with a bisphosphonate . METHODS : In a r and omized , open-label study , postmenopausal women received 60 mg denosumab subcutaneously every 6 months ( n=417 ) or 150 mg ib and ronate orally every month ( n=416 ) for 12 months . End points included percentage change from baseline in total hip , femoral neck , and lumbar spine BMD at month 12 and percentage change from baseline in serum C-telopeptide at months 1 and 6 in a sub study . RESULTS : At month 12 , significantly greater BMD gains from baseline were observed with denosumab compared with ib and ronate at the total hip ( 2.3 % compared with 1.1 % ) , femoral neck ( 1.7 % compared with 0.7 % ) , and lumbar spine ( 4.1 % compared with 2.0 % ; treatment difference P<.001 at all sites ) . At month 1 , median change in serum C-telopeptide from baseline was −81.1 % with denosumab and –35.0 % with ib and ronate ( P<.001 ) ; the treatment difference remained significant at month 6 ( P<.001 ) . Adverse events occurred in 245 ( 59.6 % ) denosumab-treated women and 230 ( 56.1 % ) ib and ronate-treated women ( P=.635 ) . The incidence of serious adverse events was 9.5 % for denosumab-treated women and 5.4 % for ib and ronate-treated women ( P=.046 ) . No clustering of events in any organ system accounted for the preponderance of these reports . The incidence rates of serious adverse events involving infection and malignancy were similar between treatment groups . CONCLUSION : In postmenopausal women previously treated with a bisphosphonate and low BMD , denosumab treatment result ed in greater BMD increases than ib and ronate at all measured sites . No new safety risks with denosumab treatment were identified . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00936897 . LEVEL OF EVIDENCE : BACKGROUND Receptor activator of nuclear factor-kappaB lig and ( RANKL ) is essential for osteoclast differentiation , activation , and survival . The fully human monoclonal antibody denosumab ( formerly known as AMG 162 ) binds RANKL with high affinity and specificity and inhibits RANKL action . METHODS The efficacy and safety of subcutaneously administered denosumab were evaluated over a period of 12 months in 412 postmenopausal women with low bone mineral density ( T score of -1.8 to -4.0 at the lumbar spine or -1.8 to -3.5 at the proximal femur ) . Subjects were r and omly assigned to receive denosumab either every three months ( at a dose of 6 , 14 , or 30 mg ) or every six months ( at a dose of 14 , 60 , 100 , or 210 mg ) , open-label oral alendronate once weekly ( at a dose of 70 mg ) , or placebo . The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months . Changes in bone turnover were assessed by measurement of serum and urine telopeptides and bone-specific alkaline phosphatase . RESULTS Denosumab treatment for 12 months result ed in an increase in bone mineral density at the lumbar spine of 3.0 to 6.7 percent ( as compared with an increase of 4.6 percent with alendronate and a loss of 0.8 percent with placebo ) , at the total hip of 1.9 to 3.6 percent ( as compared with an increase of 2.1 percent with alendronate and a loss of 0.6 percent with placebo ) , and at the distal third of the radius of 0.4 to 1.3 percent ( as compared with decreases of 0.5 percent with alendronate and 2.0 percent with placebo ) . Near-maximal reductions in mean levels of serum C-telopeptide from baseline were evident three days after the administration of denosumab . The duration of the suppression of bone turnover appeared to be dose-dependent . CONCLUSIONS In postmenopausal women with low bone mass , denosumab increased bone mineral density and decreased bone resorption . These preliminary data suggest that denosumab might be an effective treatment for osteoporosis . ( Clinical Trials.gov number , NCT \n Output:\n " }, { "from": "agent", "value": "CONCLUSION Denosumab can be used both as a first-line agent and an alternative to bisphosphonate in the treatment of postmenopausal osteoporosis .\nThere is currently insufficient data to show that denosumab is not inferior to bisphosphonates in fracture prevention" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Abnormal bleeding after cardiopulmonary bypass ( CPB ) is a common complication of cardiac surgery , with important health and economic consequences . Coagulation test – based algorithms may reduce transfusion of non-erythrocyte allogeneic blood in patients with abnormal bleeding . Methods The authors performed a r and omized prospect i ve trial comparing allogeneic transfusion practice s in 92 adult patients with abnormal bleeding after CPB . Patients with abnormal bleeding were r and omized to one of two groups : a control group following individual anesthesiologist ’s transfusion practice s and a protocol group using a transfusion algorithm guided by coagulation tests . Results Among 836 eligible patients having all types of elective cardiac surgery requiring CPB , 92 patients developed abnormal bleeding after CPB ( incidence , 11 % ) . The transfusion algorithm group received less allogeneic fresh frozen plasma in the operating room after CPB ( median , 0 units ; range , 0–7 units ) than the control group ( median , 3 units ; range , 0–10 units ) ( P = 0.0002 ) . The median number of platelet units transfused in the operating room after CPB was 4 ( range , 0–12 ) in the algorithm group compared with 6 ( range , 0–18 ) in the control group ( P = 0.0001 ) . Intensive care unit ( ICU ) mediastinal blood loss was significantly less in the algorithm group . Multivariate analysis demonstrated that transfusion algorithm use result ed in reduced ICU blood loss . The control group also had a significantly greater incidence of surgical reoperation of the mediastinum for bleeding ( 11.8%vs . 0%;P = 0.032 ) . Conclusions Use of a coagulation test – based transfusion algorithm in cardiac surgery patients with abnormal bleeding after CPB reduced non-erythrocyte allogeneic transfusions in the operating room and ICU blood loss Introduction : The current investigation aim ed to study the efficacy of hemostatic therapy guided either by conventional coagulation analyses or point-of-care ( POC ) testing in coagulopathic cardiac surgery patients . Methods : Patients undergoing complex cardiac surgery were assessed for eligibility . Those patients in whom diffuse bleeding was diagnosed after heparin reversal or increased blood loss during the first 24 postoperative hours were enrolled and r and omized to the conventional or POC group . Thromboelastometry and whole blood impedance aggregometry have been performed in the POC group . The primary outcome variable was the number of transfused units of packed erythrocytes during the first 24 h after inclusion . Secondary outcome variables included postoperative blood loss , use and costs of hemostatic therapy , and clinical outcome parameters . Sample size analysis revealed a sample size of at least 100 patients per group . Results : There were 152 patients who were screened for eligibility and 100 patients were enrolled in the study . After r and omization of 50 patients to each group , a planned interim analysis revealed a significant difference in erythrocyte transfusion rate in the conventional compared with the POC group [ 5 ( 4;9 ) versus 3 ( 2;6 ) units [ median ( 25th and 75th percentile ) ] , P < 0.001 ] . The study was terminated early . The secondary outcome parameters of fresh frozen plasma and platelet transfusion rates , postoperative mechanical ventilation time , length of intensive care unit stay , composite adverse events rate , costs of hemostatic therapy , and 6-month mortality were lower in the POC group . Conclusions : Hemostatic therapy based on POC testing reduced patient exposure to allogenic blood products and provided significant benefits with respect to clinical outcomes BACKGROUND Using algorithms based on point of care coagulation tests can decrease blood loss and blood component transfusion after cardiac surgery . We wished to test the hypothesis that a management algorithm based on near-patient tests would reduce blood loss and blood component use after routine coronary artery surgery with cardiopulmonary bypass when compared with an algorithm based on routine laboratory assays or with clinical judgement . METHODS Patients ( n=102 ) undergoing elective coronary artery surgery with cardiac bypass were r and omized into two groups . In the point of care group , the management algorithm was based on information provided by three devices , the Hepcon , thromboelastography and the PFA-100 platelet function analyser . Management in the laboratory test group depended on rapidly available laboratory clotting tests and transfusion of haemostatic blood components only if specific criteria were met . Blood loss and transfusion was compared between these two groups and with a retrospective case-control group ( n=108 ) , in which management of bleeding had been according to the clinician 's discretion . RESULTS All three groups had similar median blood losses . The transfusion of packed red blood cells ( PRBCs ) and blood components was greater in the clinician discretion group ( P<0.05 ) but there was no difference in the transfusion of PRBCs and blood components between the two algorithm-guided groups . CONCLUSION Following algorithms based on point of care tests or on structured clinical practice with st and ard laboratory tests does not decrease blood loss , but reduces the transfusion of PRBCs and blood components after routine cardiac surgery , when compared with clinician discretion . Cardiac surgery services should use transfusion guidelines based on laboratory-guided algorithms , and the possible benefits of point of care testing should be tested against this st and ard We set out to determine if the heparinase-modified thrombelastogram using anticoagulated blood from patients during cardiac surgery could guide treatment with haemostatic components . In 60 patients a simple algorithm predicted a possible 60 - 80 % decrease in the use of haemostatic components . In a second series , 30 patients were allocated to receive components using this intra-operative algorithm and 30 using clinical criteria and laboratory-based tests . Ten patients in the clinical group received a total of 16 units of fresh frozen plasma and nine platelet concentrates compared with five patients transfused with five units of fresh frozen plasma and one platelet concentrate in the algorithm group . Twelve-hour chest tube losses [ algorithm group 470 ( 295 - 820 ) ml , clinical ly managed group 390 ( 240 - 820 ) ml ( median , quartile values ) ] were not different between groups despite the threefold reduction in the use of haemostatic products , showing that intra-operative monitoring of coagulation in the anticoagulated patient can be used to guide treatment BACKGROUND Thromboelastometric evaluation of coagulation might be useful for prediction and management of bleeding after paediatric cardiac surgery . We tested the hypothesis that the use of a thromboelastometry-guided algorithm for blood product management reduces blood loss and transfusion requirements . METHODS We studied 78 patients undergoing paediatric cardiac surgery with cardiopulmonary bypass ( CPB ) for the initial 12 h after operation . Stepwise multiple linear regression was used to develop an algorithm to guide blood product transfusions . Thereafter , we r and omly assigned 100 patients to conventional or algorithm-guided blood product management , and assessed bleeding and red cell transfusion requirements . RESULTS CPB time , post-bypass rotational thromboelastometry ( ROTEM ( ® ) ) EXTEM amplitude at 10 min ( A10 ) , and FIBTEM-A10 were independently associated with chest tube drainage volume during the initial 12 h after operation . Discriminative analysis determined cut-off values of 30 mm for EXTEM-A10 and 5 mm for FIBTEM-A10 , and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes . Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding ( 9 vs 16 ml kg(-1 ) , P<0.001 ) and packed red cell transfusion requirement ( 11 vs 23 ml kg(-1 ) , P=0.005 ) at 12 h after surgery , and duration of critical care stay ( 60 vs 71 h , P=0.014 ) . CONCLUSIONS Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A10 and FIBTEM-A10 reduced blood loss and red cell transfusion requirements after CPB , and reduced critical care duration in paediatric cardiac surgical patients . CLINICAL TRIAL REGISTRATION UMIN Clinical Trials Registry UMIN000006832 ( December 4 , 2011 ) OBJECTIVE To investigate if the use of preoperative platelet function testing ( PFT ) as part of a transfusion algorithm reduced blood product usage in coronary artery bypass surgery ( CABG ) . DESIGN Prospect i ve , r and omized , controlled trial . SETTING A cardiothoracic hospital . PARTICIPANTS 249 patients having CABG surgery . INTERVENTIONS The patients were allocated r and omly to PFT preoperatively with Multiple Electrode Aggregometry ( MEA , Group A ) , TEG PlateletMapping ( PM , Group B ) or none ( control , Group C ) . Post-bypass bleeding management was determined by a transfusion algorithm . MEASUREMENTS AND MAIN RESULTS The primary outcome measure was blood product transfusion in the first 48 hours post-surgery . There was a significant reduction in all blood product transfusion between Groups A ( MEA ) and B ( PM ) and Group C ( control ) ( median number of units transfused , 2 (A)/2 (B)/ 4(C ) , p=0.02 ) . Those in A and B received fewer units of red cells ( median number of units , 0 (A)/1 ( B ) /2 ( C ) , p=0.006 ) and fresh frozen plasma than the control Group C ( median number of units , 0 (A)/0 (B)/2 ( C ) , p<0.001 ) , without receiving significantly more units of platelets ( median number of units , 1 (A)/1 (B)/0 ( C ) , p=0.11 ) . In those who had taken an adenosine disphosphate (ADP)-receptor antagonist within 5 days ( n=173 ) , these results were amplified , and additionally , there was a significant cost saving ( median cost , A=£1738.53 , B=£1736.96 , C=£3191.80 p=0.006 ) . CONCLUSION Preoperative PFT as part of a point-of-care testing-based transfusion algorithm led to a reduction in blood transfusion . There is a potential cost saving in those who have taken an ADP-receptor antagonist within 5 days BACKGROUND The protease inhibitor aprotinin reduces hemostatic activation and blood loss after cardiac operations . The aim of the present study was to investigate the influence of two different aprotinin doses on hemostatic activation and to identify the most effective dose to reduce the postoperative bleeding tendency . METHODS In a prospect i ve , r and omized , double-blind clinical trial , 230 patients scheduled for routine open heart operations received either high-dose ( group H ) or low-dose ( group L ) aprotinin . Primary outcome measures were the level of F(1 + 2 ) prothrombin fragments as a marker of thrombin generation , the level of D-dimers as an indicator of fibrinolysis , and the amount of postoperative blood loss . Allogeneic blood transfusion was recorded as a secondary outcome measure . RESULTS Aprotinin plasma concentrations 5 minutes after the onset of cardiopulmonary bypass were 166 + /- 45 kallikrein inactivator units per milliliter in group H and 118 + /- 30 kallikrein inactivator units per milliliter in group L ( p < 0.05 ) . Fibrinolytic activation was reduced significantly in group H compared with group L : the level of D-dimers at the end of CPB was 1,027 + /- 781 ng/mL and 1,977 + /- 1,001 ng/mL , respectively , in the two groups ( p < 0.05 ) . However , thrombin generation ( F(1 + 2 ) fragments ) did not differ between the two groups ( 7.4 + /- 3.5 nmol/L in group H and 8.6 + /- 4.3 nmol/L in group L ) . Twenty-four-hour postoperative blood loss was 663 + /- 461 mL in group H compared with 877 + /- 513 mL in group L ( p < 0.05 ) , and the corresponding allogeneic blood requirement was 1.3 + /- 1.9 U in group H and 1.9 + /- 2.3 U in group L ( p < 0.05 ) . CONCLUSIONS A high-dose aprotinin regimen was significantly more effective than a low-dose regimen in attenuating fibrinolysis and reducing the bleeding tendency and allogeneic blood requirements , but not in reducing F(1 + 2 ) prothrombin fragments . High-dose aprotinin therapy appears to be superior to low-dose therapy Platelet function can be easily measured as time to peak ( TP ) by Sonoclot Coagulation & Platelet Function Analyzer ( Sienco Inc. , Morrison , CO ) analysis . However a correlation between Sonoclot analysis and platelet aggregation , which is accepted as a test of platelet function , has not been established . In this study , we compared TP and collagen-induced whole blood platelet aggregation in 15 patients undergoing cardiac surgery . Two or three blood sample s were r and omly obtained from each patient before and after cardiopulmonary bypass ( CPB ) . Sonoclot analysis , collagen-induced whole blood aggregation , and laboratory \n Output:\n " }, { "from": "agent", "value": "Routine use of viscoelastic point-of-care tests did not improve important clinical outcomes beyond transfusion in adults undergoing cardiac surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This is the first in vivo demonstration of an association between endogenous neurotransmitter release and conscious experience . Using 11C-raclopride PET we demonstrated increased endogenous dopamine release in the ventral striatum during Yoga Nidra meditation . Yoga Nidra is characterized by a depressed level of desire for action , associated with decreased blood flow in prefrontal , cerebellar and subcortical regions , structures thought to be organized in open loops subserving executive control . In the striatum , dopamine modulates excitatory glutamatergic synapses of the projections from the frontal cortex to striatal neurons , which in turn project back to the frontal cortex via the pallidum and ventral thalamus . The present study was design ed to investigate whether endogenous dopamine release increases during loss of executive control in meditation . Participants underwent two 11C-raclopride PET scans : one while attending to speech with eyes closed , and one during active meditation . The tracer competes with endogenous dopamine for access to dopamine D2 receptors predominantly found in the basal ganglia . During meditation , 11C-raclopride binding in ventral striatum decreased by 7.9 % . This corresponds to a 65 % increase in endogenous dopamine release . The reduced raclopride binding correlated significantly with a concomitant increase in EEG theta activity , a characteristic feature of meditation . All participants reported a decreased desire for action during meditation , along with heightened sensory imagery . The level of gratification and the depth of relaxation did not differ between the attention and meditation conditions . Here we show increased striatal dopamine release during meditation associated with the experience of reduced readiness for action . It is suggested that being in the conscious state of meditation causes a suppression of cortico-striatal glutamatergic transmission . To our knowledge this is the first time in vivo evidence has been provided for regulation of conscious states at a synaptic level Sahaj Yoga is a meditative technique that has been found to have beneficial effects in some psycho-somatic illnesses . The study was carried out on 30 cases ( 19 Males , 11 females , age 18 - 45 years ) of major depression diagnosed on the basis of DSM IV criteria . The patients were then r and omly divided into two groups : Group 1 : ( 10 Males & 5 Females ) Patients who were practising Sahaj Yoga and also received conventional anti-depressants . Group 2 : ( 9 Males & 6 Females ) Patients who were only receiving conventional anti-depressants . Training in Sahaj yoga was conducted under the supervision of a trained Sahaj Yogi for 8 weeks . At start of the study , all the patients were subjected to Hamilton Rating Scale for Depression ( HAM-D ) and Hamilton Rating Scale for Anxiety ( HAM-A ) . Above scales were again assessed after two months of treatment . There was significant improvement in HAM-D as well as HAM-A scores in both Group 1 and Group 2 patients ( P<0.001 ) . However , percentage improvement in HAM-D scores and HAM-A scores in patients receiving Sahaj Yoga was significantly higher than in Group 2 patients . The number of patients who went into remission after two months of intervention were also significantly higher in Group 1 patients ( P=0.02 ) . The present study demonstrates that Sahaj Yoga has got a potential role as a component in the management of depressive disorders Cognitive functions are impaired in Major Depression . Studies on the effects of Yoga on cognitive functions have shown improvement in memory , vigilance and anxiety levels . 30 patients suffering from Major depression ( age 18 to 45 years ) were r and omly divided into two groups : Group 1 : ( 10 males and 5 Females ) Patients who practised Sahaj Yoga meditation and also received conventional anti-depressant medication . Group 2 : ( 9 males and 6 Females ) Patients who only received conventional antidepressant medication . Group 1 patients were administered Sahaj Yoga practice for 8 weeks . Neuro-cognitive test battery consisting of Letter cancellation test ( LCT ) , Trail making test ' A ' ( TTA ) , Trail making test ' B ' ( TTB ) , Ruff figural fluency test ( RFFT ) , Forward digit span ( FDS ) & Reverse digit span test ( RDS ) was used to assess following cognitive domains : Attention span , visuo-motor speed , short-term memory , working memory and executive functions . After 8 weeks , both Group 1 and Group 2 subjects showed significant improvement in LCT , TTA & TTB but improvement in LCT was more marked in Group 1 subjects . Also , there was significant improvement in RDS scores in only Group 1 subjects ( P < 0.05 ) . The results thereby , demonstrate that Sahaj Yoga practice in addition to the improvement in various other cognitive domains seen with conventional anti-depressants , can lead to additional improvement in executive functions like manipulation of information in the verbal working memory and added improvement in attention span and visuo-motor speed of the depressives Background : Emotional insecurity , stress , depressive or/ and anxiety symptoms are common with variable severity among patients with menstrual disorder . Yogic relaxation therapy ( Yoga Nidra ) leads to conscious and subconscious recognition of these underlying psychological factors and helps releasing of suppressed conflicts . Objective : To evaluate the effect of Yoga Nidra on anxiety and depressive symptoms in patients with menstrual disorders . Material s and Methods : Subjects were recruited from the Department of Obstetrics and Gynecology , C.S.M. Medical University ( erstwhile KGMU ) , Lucknow Uttar Pradesh , India . The subjects were r and omly divided in to two groups : Intervention group ( with yogic intervention ) and control group ( without yogic intervention ) . Assessment s of all subjects were carried out by administering Hamilton anxiety scale ( HAM-A ) and Hamilton rating scale for depression ( HAM-D ) at baseline and after six months . Results : The mean age with S.D of the intervention group was 27.67 ± 7.85 years , and for control group was 26.58 ± 6.87 years ( among completed intervention group nn = 65 and control group nn = 61 ) . There was significant reduction of scores in HAM-A ( P<0.003 ) and HAM-D ( P<0.02 ) respectively in subjects with mild to moderate anxiety and depressive symptoms after six months of yoga therapy ( Yoga Nidra ) in intervention group in comparison to control group . Conclusion : The patients with mild to moderate anxiety and depressive symptoms improve significantly with ‘ Yoga Nidra ’ intervention . There is no significant improvement in the patients with severe anxiety and depressive symptoms OBJECTIVES Yoga and exercise have beneficial effects on mood and anxiety . γ-Aminobutyric acid (GABA)-ergic activity is reduced in mood and anxiety disorders . The practice of yoga postures is associated with increased brain GABA levels . This study addresses the question of whether changes in mood , anxiety , and GABA levels are specific to yoga or related to physical activity . METHODS Healthy subjects with no significant medical/psychiatric disorders were r and omized to yoga or a metabolically matched walking intervention for 60 minutes 3 times a week for 12 weeks . Mood and anxiety scales were taken at weeks 0 , 4 , 8 , 12 , and before each magnetic resonance spectroscopy scan . Scan 1 was at baseline . Scan 2 , obtained after the 12-week intervention , was followed by a 60-minute yoga or walking intervention , which was immediately followed by Scan 3 . RESULTS The yoga subjects ( n = 19 ) reported greater improvement in mood and greater decreases in anxiety than the walking group ( n = 15 ) . There were positive correlations between improved mood and decreased anxiety and thalamic GABA levels . The yoga group had positive correlations between changes in mood scales and changes in GABA levels . CONCLUSIONS The 12-week yoga intervention was associated with greater improvements in mood and anxiety than a metabolically matched walking exercise . This is the first study to demonstrate that increased thalamic GABA levels are associated with improved mood and decreased anxiety . It is also the first time that a behavioral intervention ( i.e. , yoga postures ) has been associated with a positive correlation between acute increases in thalamic GABA levels and improvements in mood and anxiety scales . Given that pharmacologic agents that increase the activity of the GABA system are prescribed to improve mood and decrease anxiety , the reported correlations are in the expected direction . The possible role of GABA in mediating the beneficial effects of yoga on mood and anxiety warrants further study BACKGROUND This study examined the effects of brief daily yogic meditation on mental health , cognitive functioning , and immune cell telomerase activity in family dementia caregivers with mild depressive symptoms . METHODS Thirty-nine family dementia caregivers ( mean age 60.3 years old ( SD = 10.2 ) ) were r and omized to practicing Kirtan Kriya or listening to relaxation music for 12 min per day for 8 weeks . The severity of depressive symptoms , mental and cognitive functioning were assessed at baseline and follow-up . Telomerase activity in peripheral blood mononuclear cells ( PMBC ) was examined in peripheral P BMC pre-intervention and post-intervention . RESULTS The meditation group showed significantly lower levels of depressive symptoms and greater improvement in mental health and cognitive functioning compared with the relaxation group . In the meditation group , 65.2 % showed 50 % improvement on the Hamilton Depression Rating scale and 52 % of the participants showed 50 % improvement on the Mental Health Composite Summary score of the Short Form-36 scale compared with 31.2 % and 19 % , respectively , in the relaxation group ( p < 0.05 ) . The meditation group showed 43 % improvement in telomerase activity compared with 3.7 % in the relaxation group ( p = 0.05 ) . CONCLUSION This pilot study found that brief daily meditation practice s by family dementia caregivers can lead to improved mental and cognitive functioning and lower levels of depressive symptoms . This improvement is accompanied by an increase in telomerase activity suggesting improvement in stress-induced cellular aging . These results need to be confirmed in a larger sample The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . OBJECTIVES This study investigated the perceived influence of yoga on body perception and psychosocial aspects of life for patients with chronic neck pain . DESIGN This qualitative study was conducted using semist and ardized interviews . SETTING The interventions and interviews took place in a referral center 's research department . SUBJECTS Eighteen ( 18 ) patients with chronic nonspecific neck pain were recruited from a larger r and omized controlled trial of yoga for chronic neck pain . INTERVENTIONS Participants attended 90 minutes of Iyengar yoga once a week for 9 weeks . OUTCOME MEASURES Participants completed a drawing of their neck and shoulder regions to reflect their subjective body perceptions before and after their yoga program . Semist and ardized interviews were used to explore their body perception , emotional status , everyday life and coping skills , as well as any perceived changes in these dimensions postparticipation . An interdisciplinary group analyzed the study data using content analysis techniques . RESULTS Participants reported change on five dimensions of human experience : physical , cognitive , emotional , behavioral , and social . Physically , most participants cited renewed body awareness , both during their yoga practice and in their daily lives . Such change was echoed in their postparticipation body drawings . Cognitively , participants reported increased perceived control over their health . Emotionally , they noted greater acceptance of their pain and life burdens . Behaviorally , they described enhanced use of active coping strategies . Finally , socially , they reported renewed participation in an active life . CONCLUSIONS Participants linked yoga to change on all dimensions of human experience , attributing reduced pain levels , increased coping ability , better pain acceptance and increased control to it . Body awareness appeared a key mechanism in these changes Objectives . This study compares the effects of an integrated yoga program with brief supportive therapy in breast cancer out patients undergoing adjuvant radiotherapy at a cancer center . Methods . Eighty-eight stage II and III breast cancer out patients are r and omly assigned to receive yoga ( n = 44 ) or brief supportive therapy ( n = 44 ) prior to radiotherapy treatment . Assessment s include diurnal salivary cortisol levels 3 days before and after radiotherapy and self-ratings of anxiety , depression , and stress collected before and after 6 weeks of radiotherapy . Results . Analysis of covariance reveals significant decreases in anxiety ( P < .001 ) , depression ( P = .002 ) , perceived stress ( P < .001 ) , 6 a.m. salivary cortisol ( P = .009 ) , and pooled mean cortisol ( P = .03 ) in the yoga group compared with controls . There is a significant positive correlation between morning salivary cortisol level and anxiety and depression . Conclusion . Yoga might have a role in managing self-reported psychological distress and modulating circadian patterns of stress hormones in early breast cancer patients undergoing adjuvant radiotherapy BACKGROUND Laughter Yoga founded by M. Kataria is a combination of unconditioned laughter and yogic breathing . Its effect on mental and physical aspects of healthy individuals was shown to be beneficial . OBJECTIVE The objective of this study was to compare the effectiveness of Kataria 's Laughter Yoga and group exercise therapy \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses revealed evidence for effects in patients with depressive disorders and in individuals with elevated levels of depression .\nDespite method ological drawbacks of the included studies , yoga could be considered an ancillary treatment option for patients with depressive disorders and individuals with elevated levels of depression" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose Exercise training is an effective and safe way to counteract cancer-related fatigue ( CRF ) and to improve health-related quality of life ( HRQoL ) . High-intensity interval training has proven beneficial for the health of clinical population s. The aim of this r and omized controlled trial was to compare the effects of resistance and high-intensity interval training ( RT – HIIT ) , and moderate-intensity aerobic and high-intensity interval training ( AT – HIIT ) to usual care ( UC ) in women with breast cancer undergoing chemotherapy . The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms . Methods Two hundred and forty women planned to undergo chemotherapy were r and omized to supervised RT – HIIT , AT – HIIT , or UC . Measurements were performed at baseline and at 16 weeks . Question naires included Piper Fatigue Scale , EORTC-QLQ-C30 , and Memorial Symptom Assessment Scale . Results The RT – HIIT group was superior to UC for CRF : total CRF ( p = 0.02 ) , behavior/daily life ( p = 0.01 ) , and sensory/physical ( p = 0.03 ) CRF . Role functioning significantly improved while cognitive functioning was unchanged for RT – HIIT compared to declines shown in the UC group ( p = 0.04 ) . AT – HIIT significantly improved emotional functioning versus UC ( p = 0.01 ) and was superior to UC for pain symptoms ( p = 0.03 ) . RT – HIIT reported a reduced symptom burden , while AT – HIIT remained stable compared to deteriorations shown by UC ( p < 0.01 ) . Only RT – HIIT was superior to UC for total symptoms ( p < 0.01 ) . Conclusions 16 weeks of resistance and HIIT was effective in preventing increases in CRF and in reducing symptom burden for patients during chemotherapy for breast cancer . These findings add to a growing body of evidence supporting the inclusion of structured exercise prescriptions , including HIIT , as a vital component of cancer rehabilitation . Trial registration Clinical trials.gov Registration Number : NCT02522260 Background Promoting quality of life ( QoL ) is a key priority in cancer care . We investigated the hypothesis that , in comparison to usual care , exercise post-neoadjuvant chemoradiation therapy/prior to surgical resection will reduce pain , fatigue , and insomnia , and will improve physical and mental health perceptions in patients with locally advanced stage rectal cancer . Methods In this non-r and omized controlled pilot trial , patients in the supervised exercise group ( EG ; Mage = 64 years ; 64 % male ) and in the control group ( CG ; Mage = 72 years ; 69 % male ) completed the European Organization for Research and Treatment of Cancer core Quality of Life question naire and the R AND 36-Item Health Survey three times : pre-neoadjuvant chemoradiation therapy ( Time 1 ; nEC = 24 ; nCG = 11 ) , post-neoadjuvant chemoradiation therapy/pre-exercise intervention ( Time 2 ; nEC = 23 ; nCG = 10 ) , and post-exercise intervention ( Time 3 ; nEC = 22 ; nCG = 10 ) . The 6-week exercise intervention was delivered in hospital and comprised of interval aerobic training . Patients trained in pairs three times per week for 30 to 40 min . Data were analyzed by Mann – Whitney tests and by Wilcoxon matched-pairs signed-rank tests . Results No significant between-group differences in changes were found for any of the outcomes . In both groups , fatigue levels decreased and physical health perceptions increased from pre- to post-exercise intervention . Pain levels also decreased from pre- to post-exercise intervention , albeit not significantly . Conclusions The findings from this study can be used to guide a more definitive trial as they provide preliminary evidence regarding the potential effects of pre-operative exercise on self-reported pain , fatigue , insomnia , and health perceptions in patients with locally advanced rectal cancer . Trial registration : This study has been registered with clinical trials.gov ( NCT01325909 ; March 29 , 2011 ) BACKGROUND Patients requiring surgery for locally advanced rectal cancer often additionally undergo neoadjuvant chemoradiotherapy ( NACRT ) , of which the effects on physical fitness are unknown . The aim of this feasibility and pilot study was to investigate the effects of NACRT and a 6 week structured responsive exercise training programme ( SRETP ) on oxygen uptake [ Formula : see text ] at lactate threshold ( [ Formula : see text ] ) in such patients . METHODS We prospect ively studied 39 consecutive subjects ( 27 males ) with T3 - 4/N+ resection margin threatened rectal cancer who completed st and ardized NACRT . Subjects underwent cardiopulmonary exercise testing at baseline ( pre-NACRT ) , at week 0 ( post-NACRT ) , and week 6 ( post-SRETP ) . Twenty-two subjects undertook a 6 week SRETP on a training bike ( three sessions per week ) between week 0 and week 6 ( exercise group ) . These were compared with 17 contemporaneous non-r and omized subjects ( control group ) . Changes in [ Formula : see text ] at [ Formula : see text ] over time and between the groups were compared using a compound symmetry covariance linear mixed model . RESULTS Of 39 recruited subjects , 22 out of 22 ( exercise ) and 13 out of 17 ( control ) completed the study . There were differences between the exercise and control groups at baseline [ age , ASA score physical status , World Health Organisation performance status , and Colorectal Physiologic and Operative Severity Score for the Enumeration of Mortality and Morbidity ( CR-POSSUM ) predicted mortality ] . In all subjects , [ Formula : see text ] at [ Formula : see text ] significantly reduced between baseline and week 0 [ -1.9 ml kg(-1 ) min(-1 ) ; 95 % confidence interval ( CI ) -1.3 , -2.6 ; P<0.0001 ] . In the exercise group , [ Formula : see text ] at [ Formula : see text ] significantly improved between week 0 and week 6 ( + 2.1 ml kg(-1 ) min(-1 ) ; 95 % CI + 1.3 , + 2.9 ; P<0.0001 ) , whereas the control group values were unchanged ( -0.7 ml kg(-1 ) min(-1 ) ; 95 % CI -1.66 , + 0.37 ; P=0.204 ) . CONCLUSIONS NACRT before rectal cancer surgery reduces physical fitness . A structured exercise intervention is feasible post-NACRT and returns fitness to baseline levels within 6 weeks . CLINICAL TRIAL REGISTRATION NCT 01325909 OBJECTIVES Poor aerobic fitness is a potential modifiable risk factor for long-term survival and quality of life in patients with lung cancer . This r and omized trial evaluates the impact of adding rehabilitation ( Rehab ) with high-intensity interval training ( HIIT ) before lung cancer surgery to enhance cardiorespiratory fitness and improve long-term postoperative outcome . METHODS Patients with operable lung cancer were r and omly assigned to usual care ( UC , n = 77 ) or to intervention group ( Rehab , n = 74 ) that entailed HIIT that was implemented only preoperatively . Cardiopulmonary exercise testing ( CPET ) and pulmonary functional tests ( PFTs ) including forced vital capacity ( FVC ) , forced expiratory volume ( FEV 1 ) and carbon monoxide transfer factor ( KCO ) were performed before and 1 year after surgery . RESULTS During the preoperative waiting time ( median 25 days ) , Rehab patients participated to a median of 8 HIIT sessions ( interquartile [ IQ ] 25 - 75 % , 7 - 10 ) . At 1 year follow-up , 91 % UC patients and 93 % Rehab patients were still alive ( P = 0.506 ) . Pulmonary functional changes were non-significant and comparable in both groups ( FEV 1 mean -7.5 % , 95 % CI , -3.6 to -12.9 and in KCO mean 5.8 % 95 % CI 0.8 - 11.8 ) Compared with preoperative CPET results , both groups demonstrated similar reduction in peak oxygen uptake ( mean -12.2 % 95 % CI -4.8 to -18.2 ) and in peak work rate ( mean -11.1 % 95 % CI -4.2 to -17.4 ) . CONCLUSIONS Short-term preoperative rehabilitation with HIIT does not improve pulmonary function and aerobic capacity measured at 1 year after lung cancer resection . TRIAL REGISTRY Clinical Trials.gov ; No. NCT01258478 ; www . clinical trials.gov Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES The aim of this study was to determine whether ectopic fat depots are prospect ively associated with cardiovascular disease , cancer , and all-cause mortality . BACKGROUND The morbidity associated with excess body weight varies among individuals of similar body mass index . Ectopic fat depots may underlie this risk differential . However , prospect i ve studies of directly measured fat are limited . METHODS Participants from the Framingham Heart Study ( n = 3,086 ; 49 % women ; mean age of 50.2 years ) underwent assessment of fat depots ( visceral adipose tissue , pericardial adipose tissue , and periaortic adipose tissue ) using multidetector computed tomography and were followed up longitudinally for a median of 5.0 years . Cox proportional hazards regression models were used to examine the association of each fat depot ( per 1 SD increment ) with the risk of incident cardiovascular disease , cancer , and all-cause mortality after adjustment for st and ard risk factors , including body mass index . RESULTS Overall , there were 90 cardiovascular events , 141 cancer events , and 71 deaths . After multivariable adjustment , visceral adipose tissue was associated with cardiovascular disease ( hazard ratio : 1.44 ; 95 % confidence interval : 1.08 to 1.92 ; p = 0.01 ) and cancer ( hazard ratio : 1.43 ; 95 % confidence interval : 1.12 to 1.84 ; p = 0.005 ) . Addition of visceral adipose tissue to a multivariable model that included body mass index modestly improved cardiovascular risk prediction ( net reclassification improvement of 16.3 % ) . None of the fat depots were associated with all-cause mortality . CONCLUSIONS Visceral adiposity is associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and generalized adiposity . These findings support the growing appreciation of a pathogenic role of ectopic fat BACKGROUND Development of this guideline was undertaken by the Exercise for People with Cancer Guideline Development Group , a group organized by Cancer Care Ontario 's Program in Evidence -Based Care ( pebc ) . The purpose of the guideline was to provide guidance for clinicians with respect to exercise for patients living with cancer , focusing on the benefits of specific types of exercise , recommendations about screening requirements for new referrals , and safety concerns . METHODS Consistent with the pebc 's st and ardized approach , a systematic search was conducted for existing guidelines , and systematic literature search es were performed in medline and embase for both systematic review s and primary literature . Content and methodology experts performed an internal review , which was followed by an external review by targeted experts and intended users . RESULTS The search identified three guidelines , eighteen systematic review s , and twenty-nine r and omized controlled trials with relevance to the topic . The present guideline provides recommendations for the duration , frequency , and intensity of exercise appropriate for people living with cancer . It also provides recommendations for pre-exercise assessment , safety concerns , and delivery models . CONCLUSIONS There is sufficient evidence to show that exercise provides benefits in quality of life and muscular and aerobic fitness for people with cancer both during and after treatment , and that it does not cause harm . The present guideline is intended to support the Canadian Society for Exercise Physiology 's Canadian physical activity guidelines . The recommendations are intended for clinicians and institutions treating cancer patients in Ontario , and for policymakers and program planners involved in the delivery of exercise programs for cancer patients Purpose Peak oxygen consumption ( VO2peak ) is an important predictive factor for long-term prognosis in patients with non-small cell lung cancer ( NSCLC ) . The purpose of this study was to investigate whether 8 weeks of exercise training improves exercise capacity , as assessed by VO2peak , and other related factors in patients with NSCLC receiving targeted therapy . Methods A total of 24 participants with adenocarcinoma were r and omly assigned to either the control group ( n = 11 ) or the exercise group ( n = 13 ) . Subjects in the exercise group participated in individualized , high-intensity aerobic interval training of exercise . The outcome measures assessed at baseline and after 8 weeks were as follows : VO2peak and the percentage of predicted VO2peak ( % predVO2peak ) , muscle strength and endurance of the right quadriceps , muscle oxygenation during exercise , insulin resistance as calculated by the homeost \n Output:\n " }, { "from": "agent", "value": "Similarly , no superior effects of HIIT compared to MIE were found for quality of life or changes in lean mass , while evidence was provided for a larger reduction in fat mass .\nConclusion This systematic review showed that short-term HIIT induces similar positive effects on physical fitness and health-related outcomes as MIE but seems to be superior compared to UC .\nThus , HIIT might be a time-efficient intervention for cancer patients across all stages of therapy and aftercare .\nImplication s for Cancer SurvivorsHigh-intensity interval training ( HIIT ) is superior compared to usucal care in improving physical fitness and health-related outcomes in cancer patients across all stages of therapy and aftercare .\nCurrently , there is no evidence for the benefits of HIIT compared to aerobic training of moderate intensity ( MIE ) for changes in cardiorespiratory fitness , lean mass and patient-reported outcomes .\nReductions in fat mass may be more pronounced in HIIT compared to MIE when training is performed in aftercare" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS Previous studies have shown that abstinent heroin addicts exhibit an attentional bias to heroin-related stimuli . It has been suggested that attentional bias may represent a vulnerability to relapse into drug use . In the present study , the predictive value of pre-treatment attentional bias on relapse was examined in a population of abstinent heroin addicts . Further , the effect of cue exposure therapy ( CET ) on attentional bias was studied . DESIGN Participants were assigned r and omly to receive nine sessions of CET or placebo psychotherapy . SETTING An in-patient drug abuse treatment setting . PARTICIPANTS Abstinent heroin-dependent patients . MEASUREMENTS Participants completed the emotional Stroop task both before and after completing treatment . FINDINGS Pre-treatment attentional bias predicted relapse at 3-month follow-up , even when controlling for self-reported cravings at the test session . Further , attentional bias was reduced in both groups after therapy , independent of treatment condition . CONCLUSIONS Attentional bias may tap an important component of drug dependence as it is a predictor of opiate relapse . However , CET does not specifically reduce attentional bias Fifty-six heroin addicts and 60 age-matched controls were offered choices between monetary rewards ( $ 11-$80 ) available immediately and larger rewards ( $ 25-$85 ) available after delays ranging from 1 week to 6 months . Participants had a 1-in-6 chance of winning a reward that they chose on one r and omly selected trial . Delay-discounting rates were estimated from the pattern of participants ' choices . The discounting model of impulsiveness ( Ainslie , 1975 ) implies that delay-discounting rates are positively correlated with impulsiveness . On average , heroin addicts ' discount rates were twice those of controls ( p = .004 ) , and discount rates were positively correlated with impulsivity as measured by self-report question naires ( p < .05 ) . The results lend external validity to the delay-discounting rate as a measure of impulsiveness , a characteristic associated with substance abuse Cognitive-behavioral therapy ( CBT ) , because of its comparatively high level of cognitive dem and , is likely to be challenging for substance users with limitations in cognitive function . However , it is not known whether computer-assisted versions of CBT will be particularly helpful ( e.g. , allowing individualized pace and repetition ) or difficult ( e.g. , via complexity of computerized delivery ) for such patients . In this secondary analysis of data collected from a r and omized clinical trial evaluating computer-assisted CBT , four aspects of cognitive functioning were evaluated among 77 participants . Those with higher levels of risk taking completed fewer sessions and homework assignments and had poorer substance use outcomes Relapse presents a significant problem for patients recovering from stimulant dependence . Here we examined the hypothesis that patterns of brain function obtained at an early stage of abstinence differentiates patients who later relapse versus those who remain abstinent . Forty-five recently abstinent stimulant-dependent patients were tested using a r and omized event-related functional MRI ( ER-fMRI ) design that was developed in order to replicate a previous ERP study of relapse using a selective attention task , and were then monitored until 6 months of verified abstinence or stimulant use occurred . SPM revealed smaller absolute blood oxygen level-dependent ( BOLD ) response amplitude in bilateral ventral posterior cingulate and right insular cortex in 23 patients positive for relapse to stimulant use compared with 22 who remained abstinent . ER-fMRI , psychiatric , neuropsychological , demographic , personal and family history of drug use were compared in order to form predictive models . ER-fMRI was found to predict abstinence with higher accuracy than any other single measure obtained in this study . Logistic regression using fMRI amplitude in right posterior cingulate and insular cortex predicted abstinence with 77.8 % accuracy , which increased to 89.9 % accuracy when history of mania was included . Using 10-fold cross-validation , Bayesian logistic regression and multilayer perceptron algorithms provided the highest accuracy of 84.4 % . These results , combined with previous studies , suggest that the functional organization of paralimbic brain regions including ventral anterior and posterior cingulate and right insula are related to patients ' ability to maintain abstinence . Novel therapies design ed to target these paralimbic regions identified using ER-fMRI may improve treatment outcome Cognitive-behavioral therapy ( CBT ) depends on adequate cognitive functioning in patients , but prolonged cocaine use may impair cognitive functioning . Therefore , cognitive impairment may impede the ability of cocaine abusers to benefit from CBT . To begin to address this issue , we investigated the relationship between cognitive impairment and two treatment outcomes , therapy completion and abstention . Eighteen carefully screened non-depressed cocaine-dependent patients in a psychopharmacological clinical trial were administered the MicroCog computerized battery to assess cognitive performance at treatment entry . T-tests were used to compare cognitive functioning between completers ( patients remaining in treatment at least 12 weeks ) and dropouts . The results indicated that treatment completers had demonstrated significantly better cognitive performance at baseline than patients who dropped out of treatment . Cognitive domains that significantly distinguished between treatment completers and dropouts were attention , mental reasoning and spatial processing . This study provides preliminary evidence that cognitive impairments may decrease treatment retention and abstinence in CBT of cocaine dependence \n Output:\n " }, { "from": "agent", "value": "We observed significant method ological differences across studies , result ing in substantial variability in the relationships between cognitive-executive domains and treatment outcomes .\nNotwithst and ing this variability , we found evidence of associations , of medium effect size , between general cognition and treatment adherence , and between reward-based decision-making and relapse .\nThe link between general cognition and treatment adherence is consistent with emerging evidence linking limited cognitive-executive re sources with less ability to benefit from talk therapies .\nThe link between reward-based decision-making and relapse accords with decision neuroscience models of addiction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To establish the first baseline of dairy and related nutrient intake in African Americans , an at-risk population of public health concern in the United States . To document dairy consumption in African Americans by age and sex during 1994 - 1998 and 1999 - 2000 and compare it with concomitant dairy , calcium , and related nutrient intakes in non-African-American adults and children . DESIGN Duplicate and single 24-hour recalls were analyzed to determine dietary intake during the Continuing Survey of Food Intakes by Individuals 1994 - 1996 , 1998 ( CSFII ) , and the National Health and Nutrition Examination Survey 1999 - 2000 ( NHANES ) , respectively . SUBJECTS African Americans and non-African Americans of all ages who participated in CSFII 1994 - 1996 , 1998 , and in NHANES 1999 - 2000 ; both surveys are a stratified r and om sample of the total civilian , noninstitutionalized US population . STATISTICAL ANALYSIS Dairy food and nutrient intake per day were quantified according to age , sex , and ethnicity/race from CSFII 1994 - 1996 , 1998 , and NHANES 1999 - 2000 . For NHANES , mean intakes from 1-day food records were sample -weighted , and st and ard errors estimated by the Taylor linearization method of SUDAAN ( version 9.0 , 2004 , RTI International , Research Triangle Park , NC ) . Usual daily intakes of calcium , magnesium , and phosphorus were based on 2-day intake data from CSFII 1994 - 1996 , 1998 , and calculated using Software for Intake Distribution from Iowa State University . The percentage of individuals categorized as not meeting the Estimated Average Requirement for magnesium and phosphorus were calculated in the same way . RESULTS CSFII 1994 - 1996 , 1998 , and NHANES 1999 - 2000 data both show that African Americans in all age groups consume fewer mean servings per day of total dairy , milk , cheese , and yogurt than non-African Americans , and have lower mean intakes of calcium , magnesium , and phosphorus . Significant differences were seen for men and women . CONCLUSIONS In this analysis , young African-American women did not meet Dietary Reference Intakes for phosphorus , and all African Americans did not meet Dietary Reference Intakes for calcium and magnesium . African Americans in all age groups did not meet dairy recommendations from the 2005 US Dietary Guidelines and the 2004 National Medical Association Consensus Report on the role of dairy and dairy nutrients in the diet of African Americans BACKGROUND Increased intake of sugar-sweetened beverages and fruit juice has been associated with overweight in children . OBJECTIVE This study prospect ively assessed beverage consumption patterns and their relationship with weight status in a cohort of children born at different risk for obesity . METHODS AND PROCEDURES Participants were children born at low risk ( n = 27 ) or high risk ( n = 22 ) for obesity based on maternal prepregnancy BMI ( kg/m(2 ) ) . Daily beverage consumption was generated from 3-day food records from children aged 3 - 6 years and coded into seven beverage categories ( milk , fruit juice , fruit drinks , caloric and non-caloric soda , soft drinks including and excluding fruit juice ) . Child anthropometric measures were assessed yearly . RESULTS High-risk children consumed a greater percentage of daily calories from beverages at age 3 , more fruit juice at ages 3 and 4 , more soft drinks ( including fruit juice ) at ages 3 - 5 , and more soda at age 6 compared to low-risk children . Longitudinal analyses showed that a greater 3-year increase in soda intake was associated with an increased change in waist circumference , whereas a greater increase in milk intake was associated with a reduced change in waist circumference . There was no significant association between change in intake from any of the beverage categories and change in BMI z-score across analyses . DISCUSSION Children 's familial predisposition to obesity may differentially affect their beverage consumption patterns . Future research should examine the extent to which dietary factors may play a role in pediatric body fat deposition over time BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P < 0.0001 ) , and consumption of SSBs decreased by -711.0 + /- 33.7 g/d ( P < 0.0001 ) . For the control group , milk consumption did not change , and consumption of SSBs increased by 71.9 + /- 33.6 g/d ( P = 0.04 ) . Changes in percentage body fat , the primary endpoint , did not differ between groups . Nevertheless , the mean ( + /- SE ) accretion of lean body mass was greater ( P = 0.04 ) in the intervention ( 0.92 + /- 0.10 kg ) than in the control ( 0.62 + /- 0.11 kg ) group . The increase in height was also greater ( P = 0.01 ) in the intervention group ( 2.50 + /- 0.21 cm ) than in the control group ( 1.77 + /- 0.20 cm ) for boys but not for girls . CONCLUSION Replacing habitual consumption of SSBs with milk may have beneficial effects on lean body mass and growth in children , despite no changes in percentage body fat . This trial was registered at clinical trials.gov as NCT00149695 BACKGROUND Little is known about the relative effectiveness of calcium supplementation from food or pills with or without vitamin D supplementation for bone mass accrual during the rapid growth period . OBJECTIVE The purpose was to examine the effects of both food-based and pill supplements of calcium and vitamin D on bone mass and body composition in girls aged 10 - 12 y. DESIGN This placebo-controlled intervention trial r and omly assigned 195 healthy girls at Tanner stage I-II , aged 10 - 12 y , with dietary calcium intakes < 900 mg/d to 1 of 4 groups : calcium ( 1000 mg ) + vitamin D3 ( 200 IU ) , calcium ( 1000 mg ) , cheese ( 1000 mg calcium ) , and placebo . Primary outcomes were bone indexes of the hip , spine , and whole body by dual-energy X-ray absorptiometry and of the radius and tibia by peripheral quantitative computed tomography . RESULTS With the use of intention-to-treat or efficacy analysis , calcium supplementation with cheese result ed in a higher percentage change in cortical thickness of the tibia than did placebo , calcium , or calcium + vitamin D treatment ( P = 0.01 , 0.038 , and 0.004 , respectively ) and in higher whole-body bone mineral density than did placebo treatment ( P = 0.044 ) when compliance was > 50 % . With the use of a hierarchical linear model with r and om effects to control for growth velocity , these differences disappeared . CONCLUSIONS Increasing calcium intake by consuming cheese appears to be more beneficial for cortical bone mass accrual than the consumption of tablets containing a similar amount of calcium . Diverse patterns of growth velocity may mask the efficacy of supplementation in a short-term trial of children transiting through puberty Evidence of an association between milk intake and childhood adiposity remains inconsistent , with few data available regarding the effects of the amount of dairy fat consumed . This study examined the relation between dairy consumption ( total , full , and reduced fat ) at age 10 y on risk of excess adiposity at age 13 y in participants of the Avon Longitudinal Study of Parents and Children ( ALSPAC ; n = 2455 ) . Intakes were assessed by 3-d dietary records . Total body fat mass ( TBFM ) using dual-energy X-ray absorptiometry was examined at 13 y. Outcomes included excess TBFM ( top quintile of TBFM ) , overweight , and change in body mass index ( BMI ) . The highest vs. lowest quartile of total dairy consumers ( g/d ) at age 10 y did not have an increased risk of excess TBFM ( OR : 0.73 ; 95 % CI : 0.46 , 1.16 ; P-trend = 0.28 ) or overweight ( OR : 0.69 ; 95 % CI : 0.41 , 1.15 ; P = 0.24 ) at age 13 y. Children in the highest quartile of full-fat dairy intakes vs. those in the lowest quartile had a reduced risk of excess TBFM ( OR : 0.64 ; 95 % CI : 0.41 , 1.00 ; P = 0.04 ) and a suggestion of a reduction in overweight ( OR : 0.65 ; 95 % CI : 0.40 , 1.06 ; P = 0.19 ) at age 13 y. Furthermore , the highest vs. lowest consumers of full-fat products had smaller gains in BMI during follow-up [ 2.5 kg/m2 ( 95 % CI : 2.2 , 2.7 ) vs. 2.8 kg/m2 ( 95 % CI : 2.5 , 3.0 ) ; P < 0.01 ] . Associations with reduced-fat dairy consumption did not attain statistical significance . In this study , dairy consumption was not related to excess fat accumulation during late childhood . Estimates had wide confidence limits but generally showed inverse relations between dairy intakes and risk of excess adiposity . Additional prospect i ve research is warranted to confirm the effects of dairy intake on obesity in children OBJECTIVE To determine whether the quantity and type of milk ( whole , reduced fat , or 1%/nonfat ) consumed at age 2 years is associated with adiposity at age 3 years . DESIGN We assessed milk and dairy intake at age 2 years with food frequency question naires completed by mothers . Our primary outcomes were body mass index ( BMI ; calculated as kg/m(2 ) ) , z score and overweight at age 3 years , defined as BMI for age and sex > or=85th percentile . SUBJECTS/ SETTING Eight-hundred and fifty-two preschool-aged children in the prospect i ve US cohort Project Viva . STATISTICAL ANALYSES Linear and logistic regression models , adjusting for maternal BMI and education , paternal BMI , and child age , sex , race/ethnicity , intake of energy , nondairy beverages , television viewing , and BMI z score at age 2 years were used . RESULTS At age 2 years , mean milk intake was 2.6 ( st and ard deviation 1.2 ) servings per day . Higher intake of whole milk at age 2 , but not reduced-fat milk , was associated with a slightly lower BMI z score ( -0.09 unit per daily serving [ 95 % confidence interval : -0.16 to -0.01 ] ) at age 3 years ; when restricted to children with a normal BMI ( 5th to < 85th percentile ) at age 2 years , the association was null ( -0.05 unit per daily serving [ 95 % confidence interval : -0.13 to 0.02 ] ) . Intake of milk at age 2 years , whether full- or reduced-fat , was not associated with risk of incident overweight at age 3 years . Neither total milk nor total dairy intake at age 2 years was associated with BMI z score or incident overweight at age 3 years . CONCLUSION Neither consuming more dairy products , nor switching from whole milk to reduced-fat milk at age 2 years , appears likely to prevent overweight in early childhood Observational studies of dietary patterns and growth and studies with milk supplementation have shown that children consuming diets containing animal source foods grow better . This study evaluates the growth of 544 Kenyan schoolchildren ( median age 7.1 y ) after 23 mo of food supplementation with a meat , milk or energy supplement ( approximately 1255 kJ ) compared to a control group without a supplement . Multivariate analyses controlled for covariates compared gain in weight , height , weight-for-height Z-score ( WHZ ) , height-for-age Z-score ( HAZ ) , mid-upper-arm circumference , triceps and subscapular skinfolds , mid-upper-arm muscle and mid-upper-arm fat area . Children in each of the supplementation groups gained approximately 0.4 \n Output:\n " }, { "from": "agent", "value": "Conclusions : Accumulated evidence from prospect i ve cohort studies suggests that dairy consumption is inversely and longitudinally associated with the risk of childhood overweight/obesity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The principal objective of these multisite studies ( Florida , New York , New Jersey : epicenters for human immunodeficiency virus [ HIV ] among women ) was to develop and implement effective combinations of behavioral interventions to optimize the health status of the most neglected and understudied population affected by the acquired immunodeficiency syndrome ( AIDS ) epidemic in the United States : poor women of color living with HIV . The two studies enrolled nearly 900 women r and omly assigned to “ high intensity ” ( cognitive – behavioral stress management training combined with expressive – supportive therapy [CBSM]+ group ) or “ low intensity ” ( individual psychoeducational program ) treatment conditions over a period of 9 years . The initial study of the stress management and relaxation training/expressive – supportive therapy ( SMART/EST ) Women ’s Project ( SWP I ) focused on reducing depression and anxiety , as well as improving self-efficacy and overall quality of life for women with case-defined AIDS . Findings from this study demonstrated the utility of CBSM+ in reducing distress ( depression , anxiety ) and denial , while improving social support , self-efficacy , coping skills , and quality of life . The second study ( SWP II ) , which included all women living with HIV , extended these findings by demonstrating that exposure to CBSM+ significantly improved the ability of the participants to take advantage of a health behavior change program encouraging the adoption and maintenance of healthier lifestyle behaviors ( high levels of medication adherence , appropriate nutritional intake and physical activity , safer sexual practice s , and reduced alcohol use/abuse ) essential for optimal health in the context of living with HIV . SWP II also determined that the intervention program was equally beneficial to less-acculturated segments of the affected population ( ie , non-English speaking HIV+ women ) through the creation of culturally and linguistically sensitive Spanish and Creole versions of the program . A third study ( SWP III ) is currently underway to “ translate ” this evidence -based treatment program into Community Health Centers in Miami , New York City , and metropolitan New Jersey UNLABELLED Women account for 1 in 5 new HIV infections in the US , make up 24 % of people living with HIV , and represent a quarter of AIDS diagnoses . Despite the need for continued prevention among young women living with HIV , there is very little in the literature on how best to reduce sexual risk and increase the health and well-being of young women living with HIV . This article explores the primary and secondary outcomes of a r and omized controlled pilot trial of an intervention entitled EVOLUTION Young Women Taking Charge and Growing Stronger . This behavioral intervention aim ed to decrease sexual risk and empower young women living with HIV by enhancing young women 's knowledge and skills pertaining to HIV risk reduction as well as to the factors that increase women 's vulnerability , such as sexual ine quality , gender , and power imbalances . Findings from this trial demonstrate that group-based behavioral interventions for young women living with HIV have promise to reduce the total number of sexual partners and reduce unprotected vaginal and anal intercourse . However , more work is needed to underst and how best to address the challenges young women face in their day to day lives that impact their sexual risk as well as their overall health and access to care and treatment Nigerian women comprise the fastest growing group of persons with AIDS in Africa . Antiretroviral therapy has transformed the course of HIV/AIDS to a treatable , chronic illness worldwide . The purpose of this pilot study was to assess the efficacy of a group intervention using motivational interviewing ( MI ) to promote adherence to antiretroviral therapy ( ART ) and use of risk reduction behaviors ( RRB ) among HIV-infected women in Nigeria . Recruited participants ( n=60 ) were r and omly assigned to the motivational group or the health promotion program ( HPP ) control group . The 6 month follow-up results indicate that , compared to the control group , MI participants reported significantly higher levels of adherence to ART , higher knowledge of HIV , higher use of condoms/protection during sexual encounters and decision-making not to have sex when no protection was available . The MI participants also had fewer mean number of sexual partners . MI in group format shows promise in promoting adherence to ART and use of RRB in HIV-infected Nigerian women Child sexual abuse ( CSA ) is associated with HIV risk behaviors [ Bensley , L. , Van Eenwyk , J. , and Simmons , K. W. , 2003 . ] and more prevalent among women living with HIV than in the general population [ Koenig , L. J. , and Clark , H. , 2004 ] . This r and omized Phase ~ I clinical trial tested the impact of a culturally congruent psychoeducational intervention design ed to reduce sexual risks and increase HIV medication adherence for HIV-positive women with CSA histories . An ethnically diverse sample of 147 women were r and omized to two conditions : an 11-session Enhanced Sexual Health Intervention ( ESHI ) or an attention control . Results based on “ intent to treat ’ ’ analysesof pre – post changes are reported here . Additional analyses explored whether theobserved effects might depend on “ intervention dose , ’ ’ i.e. , number of sessions attended . Women in the ESHI condition reported greater sexual risk reduction than women in the control condition . Although there were no differences between women in the ESHI and control groups on medication adherence , women in the ESHI condition who attended 8 or more sessions reported greater medication adherence at posttest than control women . The findings provide initial support for this culturally and gender-congruent psychoeducational intervention for HIV-positive women with CSA , and highlight the importance of addressing the effects of CSA on sexual risk reduction and medicationadherence in preventive interventions for women This article presents the results of a r and omized trial in South Africa of an adapted evidence -based Woman-Focused intervention on condom use with primary sex partners . The preliminary findings show that regardless of HIV status , condom negotiation was significantly associated with condom use at the 3- and 6-month follow-ups . By intervention group , significant intervention effects were found at 6-month follow-up for HIV-positive and HIV-unknown status women in the Woman-Focused intervention who were more likely than women in the St and ard intervention to report condom use with a primary male partner . Among HIV-positive women , those in the Woman-Focused group and those with greater sexual control were more likely to report condom use at the 6-month follow-up . The findings indicate that gender-based interventions for women may result in increased condom negotiation skills BACKGROUND Cross-sectional studies have shown that intimate partner violence and gender inequity in relationships are associated with increased prevalence of HIV in women . Yet temporal sequence and causality have been question ed , and few HIV prevention programmes address these issues . We assessed whether intimate partner violence and relationship power inequity increase risk of incident HIV infection in South African women . METHODS We did a longitudinal analysis of data from a previously published cluster-r and omised controlled trial undertaken in the Eastern Cape province of South Africa in 2002 - 06 . 1099 women aged 15 - 26 years who were HIV negative at baseline and had at least one additional HIV test over 2 years of follow-up were included in the analysis . Gender power equity and intimate partner violence were measured by a sexual relationship power scale and the WHO violence against women instrument , respectively . Incidence rate ratios ( IRRs ) of HIV acquisition at 2 years were derived from Poisson models , adjusted for study design and herpes simplex virus type 2 infection , and used to calculate population attributable fractions . FINDINGS 128 women acquired HIV during 2076 person-years of follow-up ( incidence 6.2 per 100 person-years ) . 51 of 325 women with low relationship power equity at baseline acquired HIV ( 8.5 per 100 person-years ) compared with 73 of 704 women with medium or high relationship power equity ( 5.5 per 100 person-years ) ; adjusted multivariable Poisson model IRR 1.51 , 95 % CI 1.05 - 2.17 , p=0.027 . 45 of 253 women who reported more than one episode of intimate partner violence at baseline acquired HIV ( 9.6 per 100 person-years ) compared with 83 of 846 who reported one or no episodes ( 5.2 per 100 person-years ) ; adjusted multivariable Poisson model IRR 1.51 , 1.04 - 2.21 , p=0.032 . The population attributable fractions were 13.9 % ( 95 % CI 2.0 - 22.2 ) for relationship power equity and 11.9 % ( 1.4 - 19.3 ) for intimate partner violence . INTERPRETATION Relationship power inequity and intimate partner violence increase risk of incident HIV infection in young South African women . Policy , interventions , and programmes for HIV prevention must address both of these risk factors and allocate appropriate re sources . FUNDING National Institute of Mental Health and South African Medical Research Council Throughout Africa , Peer Mentors who are women living with HIV ( WLH ) are supporting pregnant WLH at antenatal and primary healthcare clinics ( McColl in BMJ 344:e1590 , 2012 ) . We evaluate a program using this intervention strategy at 1.5 months post-birth . In a cluster r and omized controlled trial in KwaZulu-Natal , South Africa , eight clinics were r and omized for their WLH to receive either : st and ard care ( SC ) , based on national guidelines to prevent mother-to-child transmission ( 4 clinics ; n = 656 WLH ) ; or an enhanced intervention ( EI ; 4 clinics ; n = 544 WLH ) . The EI consisted of four antenatal and four postnatal small group sessions led by Peer Mentors , in addition to SC . WLH were recruited during pregnancy and 70 % were reassessed at 1.5 months post-birth . EI ’s effect was ascertained on 16 measures of maternal and infant well-being using r and om effects regressions to control for clinic clustering . A binomial test for correlated outcomes evaluated EI ’s overall effectiveness . Among EI WLH reassessed , 87 % attended at least one intervention session ( mean 4.1 , SD 2.0 ) . Significant overall benefits were found in EI compared to SC using the binomial test . However , it is important to note that EI WLH were significantly less likely to adhere to ARV during pregnancy compared to SC . Secondarily , compared to SC , EI WLH were more likely to ask partners to test for HIV , better protected their infants from HIV transmission , and were less likely to have depressed mood and stunted infants . Adherence to clinic intervention groups was low , yet , there were benefits for maternal and infant health at 1.5 months post-birth INTRODUCTION Exp and ed access to efficacious interventions is needed for women living with human immunodeficiency virus ( WLH ) in the United States . Availability of \" prevention with ( human immunodeficiency virus [ HIV ) ] positives \" interventions in rural/remote and low HIV prevalence areas remains limited , leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships ( HR ) . Offering such programs via videoconferencing groups ( VGs ) may exp and access . This analysis tests the effectiveness of HR-VG ( versus wait-list control ) for reducing sexual risk behavior among WLH and explores intervention satisfaction . SUBJECTS AND METHODS In this r and omized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across r and omization groups through zero-inflated Poisson regression modeling , controlling for unprotected sex at baseline . Seventy-one WLH were r and omized and completed the baseline assessment ( n=36 intervention and n=35 control ) ; 59 ( 83 % in each group ) had follow-up data . RESULTS Among those who engaged in unprotected sex at 6-month follow-up , intervention participants had approximately seven fewer unprotected occasions than control participants ( 95 % confidence interval 5.43 - 7.43 ) . Intervention participants reported high levels of satisfaction with HR-VG ; 84 % reported being \" very satisfied \" overall . CONCLUSIONS This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs . Important next steps will be to determine whether VGs are effective with other sub population s of people living with HIV ( i.e. , men and non-English speakers ) and to assess cost-effectiveness . Possibilities for using VGs to exp and access to other psychosocial and behavioral interventions and reduce stigma are discussed Sexual risk behavior interventions in sub-Saharan Africa focus predominantly on individual and couples counseling . This cognitive-behavioral group intervention was adapted from an urban US context to urban Zambia . Preliminary data analyses assessed the influence of partner participation on sexual risk behavior among HIV-positive Zambian women . Female participants ( n=180 ) attended four group intervention sessions and received sexual behavior skill training and male and female condoms ; male partners ( n=152 ) were r and omly assigned to high-or low-intensity genderconcordant group intervention sessions . Sexual risk behavior , strategies , attitudes , and knowledge were assessed at baseline , 6 , and 12 months . At baseline , 19 % of males reported using alcohol before sex , 10 % reported using alcohol to cope , and negative coping was associated with sexual risk behavior . In contrast , 1 % of women reported using alcohol before sex , and 15 % used alcohol as an HIV-coping strategy . Consistent barrier use was \n Output:\n " }, { "from": "agent", "value": "While more research is needed , the limited existing evidence suggests that these interventions may help support the SRH and rights of women living with HIV .\nThis review particularly highlights the importance of these interventions for preventing STIs , which present a significant health burden for women living with HIV that is rarely addressed holistically ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Geriatric evaluation and management has become st and ard care for community dwelling older adults following an acute admission to hospital . It is unclear whether this approach is beneficial for the frailest older adults living in permanent residential care . This study was undertaken to evaluate ( 1 ) the feasibility and consumer satisfaction with a geriatrician-led supported discharge service for older adults living in residential care facilities ( RCF ) and ( 2 ) its impact on the uptake of Advanced Care Planning ( ACP ) and acute health care service utilisation . Methods In 2002–4 a r and omised controlled trial was conducted in Melbourne , Australia comparing the geriatrician – led outreach service to usual care for RCF residents . Patients were recruited during their acute hospital stay and followed up at the RCF for six months . The intervention group received a post-discharge home visit within 96 hours , at which a comprehensive geriatric assessment was performed and a care plan developed . Participants and their families were also offered further meetings to discuss ACPs and document Advanced Directives ( AD ) . Additional review s were made available for assessment and management of intercurrent illness within the RCF . Consumer satisfaction was surveyed using a postal question naire . Results The study included 116 participants ( 57 intervention and 59 controls ) with comparable baseline characteristics . The service was well received by consumers demonstrated by higher satisfaction with care in the intervention group compared to controls ( 95 % versus 58 % , p = 0.006).AD were completed by 67 % of participants /proxy decision makers in the intervention group compared to 13 % of RCF residents prior to service commencement . At six months there was a significant reduction in outpatient visits ( intervention 21 ( 37 % ) versus controls 45 ( 76 % ) , ( p < 0.001 ) , but no difference in readmissions rates ( 39 % intervention versus 34 % control , p = 0.6 ) . There was a trend towards reduced hospital bed-day utilisation ( intervention 271 versus controls 372 days ) . Conclusion It is feasible to provide a supported discharge service that includes geriatrician assessment and care planning within a RCF . By exp and ing the service there is the potential for acute health care cost savings by decreasing the dem and for outpatient consultation and further reducing acute care bed-days OBJECTIVES This study describes the outcomes of an intervention program in Nursing Homes and their effects on emergency room attendance , hospital admissions , and pharmaceutical expenditure . MATERIAL AND METHODS This involved non-r and omised community intervention in Nursing Homes with a control group . The program was implemented gradually from 2007 to 2009 in 10 Nursing Homes ( 857 beds ) which participated voluntarily . The control group consisted of 14 Nursing homes ( 1,200 beds ) , which refused to participate or were not assigned to our Primary Care centres . Intervention consisted of comprehensive geriatric assessment and follow-up visits by trained personnel , review and adjustment of drug treatment , case management and staff training . RESULTS In the Nursing Homes where the program was carried out , emergency room attendance decreased from 1165‰ ( 95%CI 1100 - 1240 ] ) in 2006 to 674‰ ( 95%CI 620 - 730 ) in 2009 , while in the control group it increased from 1071 ( 95%CI 1020 - 1130 ) to 1246‰ ( 95%CI 1190 - 1310 ) . The hospital admissions also decreased from 48.4 % ( 95%CI 45 - 52 ) in 2006 to 32.1 % ( 95%CI 29 - 35 ) in 2009 , while in the control group increased from 43.5 % ( 95%CI 41 - 46 ) to 55.8 % ( 95%CI 53 - 59 ) . There was also a 9 % reduction in pharmacy cost compared with an increase of 11.9 % in the control group . CONCLUSIONS The intervention has proved effective at reducing hospital admissions and emergency room attendance in institutionalised patients , thereby streamlining pharmacy costs OBJECTIVES To examine the frequency and reasons for potentially avoidable hospitalizations of nursing home ( NH ) residents . DESIGN Medical records were review ed as a component of a project design ed to develop and pilot test clinical practice tools for reducing potentially avoidable hospitalization . SETTING NHs in Georgia . PARTICIPANTS In 10 NHs with high and 10 with low hospitalization rates , 10 hospitalizations were r and omly selected , including long- and short-stay residents . MEASUREMENTS Ratings using a structured review by expert NH clinicians . RESULTS Of the 200 hospitalizations , 134 ( 67.0 % ) were rated as potentially avoidable . Panel members cited lack of on-site availability of primary care clinicians , inability to obtain timely laboratory tests and intravenous fluids , problems with quality of care in assessing acute changes , and uncertain benefits of hospitalization as causes of these potentially avoidable hospitalizations . CONCLUSION In this sample of NH residents , experienced long-term care clinicians commonly rated hospitalizations as potentially avoidable . Support for NH infrastructure , clinical practice and communication tools for health professionals , increased attention to reducing the frequency of medically futile care , and financial and other incentives for NHs and their affiliated hospitals are needed to improve care , reduce avoidable hospitalizations , and avoid unnecessary healthcare expenditures in this population Residents of long-term care facilities have highly complex care needs and quality of care is of international concern . Maintaining resident wellness through proactive assessment and early intervention is key to decreasing the need for acute hospitalization . The Residential Aged Care Integration Program ( RACIP ) is a quality improvement intervention to support residential aged care staff and includes on-site support , education , clinical coaching , and care coordination provided by gerontology nurse specialists ( GNSs ) employed by a large district health board . The effect of the outreach program was evaluated through a r and omized comparison of hospitalization 1 year before and after program implementation . The sample included 29 intervention facilities ( 1,425 residents ) and 25 comparison facilities ( 1,128 residents ) receiving usual care . Acute hospitalization rate unexpectedly increased for both groups after program implementation , although the rate of increase was significantly less for the intervention facilities . The hospitalization rate after the intervention increased 59 % for the comparison group and 16 % for the intervention group ( rate ratio ( RR ) = 0.73 , 95 % confidence interval ( CI ) = 0.61 - 0.86 , P < .001 ) . Subgroup analysis showed a significantly lower rate change for those admitted for medical reasons for the intervention group ( 13 % increase ) than the comparison group ( 69 % increase ) ( RR = 0.67 , 95 % CI = 0.56 - 0.82 , P < .001 ) . Conversely , there was no significant difference in the RR for surgical admissions between the intervention and comparison groups ( RR = 1.0 , 95 % CI = 0.68 - 1.46 , P = .99 ) . The integration of GNS expertise through the RACIP intervention may be one approach to support staff to provide optimal care and potentially improve resident health Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES To assess the effect of a Screening Tool of Older Persons potentially inappropriate Prescriptions/Screening Tool to Alert doctors to Right Treatment ( STOPP/START ) medication intervention on clinical and economic outcomes . DESIGN Parallel-group r and omized trial . SETTING Chronic care geriatric facility . PARTICIPANTS Residents aged 65 and older prescribed with at least one medication ( N = 359 ) were r and omized to receive usual pharmaceutical care or undergo medication intervention . INTERVENTION Screening medications with STOPP/START criteria followed up with recommendations to the chief physician . MEASUREMENTS The outcome measures assessed at the initiation of the intervention and 1 year later were number of hospitalizations and falls , Functional Independence Measure ( FIM ) , quality of life ( measured using the Medical Outcomes Study 12-item Short-Form Health Survey ) , and costs of medications . RESULTS The average number of drugs prescribed was significantly lower in the intervention than in the control group after 1 year ( P < .001 ) . The average drug costs in the intervention group decreased by 103 shekels ( US$ 29 ) per participant per month ( P < .001 ) . The average number of falls in the intervention group dropped significantly ( P = .006 ) . Rates of hospitalization , FIM scores , and quality of life measurements were similar for both groups . CONCLUSION Implementation of STOPP/START criteria reduced the number of medications , falls , and costs in a geriatric facility . Their incorporation in those and similar setting s is recommended OBJECTIVE To describe the process and outcomes of nursing home ( NH ) residents transferred to hospital EDs . METHODS This was a prospect i ve , observational study conducted at 2 Midwestern community teaching hospitals during a 12-month period . All elder patients ( > 64 years of age ) transferred to hospital EDs from regional NHs were eligible for the study . Hospital records were used to abstract relevant descriptive and clinical data . Need for ambulance use was grade d prospect ively using 3 categories of urgency developed in other studies . Transfers were considered \" appropriate \" based on outcome measures or if the problem necessitated diagnostic and /or therapeutic procedures not available in the NH . Transfer documentation was evaluated using a st and ardized 18-item checklist . RESULTS A total of 709 consecutive NH patients made 1,012 ED visits . Their mean age was 83.4 years ( range 65 - 100 ) ; 76 % were female . The majority of patients ( 94 % ) were transferred by ambulance . Ambulance transfer was classified as emergent ( 16 % of patients ) , urgent ( 45 % ) , or routine ( 39 % ) . There were 319 ( 45 % ) patients subsequently admitted to the hospital . Approximately 77 % ( 546/709 ) of the NH transfers were considered appropriate by the emergency physician ( EP ) . Sixty-seven patients ( 10 % ) were transferred without any documentation . For those patients with transfer documentation , 6 common discrepancies were identified . CONCLUSION Although the majority of NH transfers in this population were appropriate , many patients were transferred without adequate documentation for the EP The dem and s of long-term care facilities ( LTCFs ) residents are complex which usually require a range of professionals and caregivers to provide treatment and care . To reduce this fragmentation of care , integrated care models are developed in modern health care system , and a gradual change from traditional LTCF care to integrated care has occurred in many countries . Although integrated care is assumed to improve the quality of care , evidence s supporting these effects are insufficient . We recruited 7 private LTCF ( 74 residents ) in northern Taipei and r and omized them into integrated care model ( N=42 , mean age=82.8+/-8.0 years , 54.8 % males ) and traditional model ( N=32 , 81.7+/-8.8 years , 43.8 % males ) . Integrated care model group was provided an actively working interdisciplinary team in addition to traditional nursing and personal care in traditional model group . Physical function , nutritional status and several quality indicators ( unplanned feeding tube replacement , unplanned urinary catheter replacement , pneumonia , urinary tract infection and so on ) were compared with both groups . Overall , LTCF residents in the integrated care model group showed significant improvement in serum levels of albumin ( 3.78+/-0.32 vs. 3.60+/-0.45 , p=0.004 ) and hemoglobin ( 12.62+/-1.58 vs. 12.03+/-1.24 , p=0.004 ) during the study period . Among selected quality indicators , subjects in integrated care model group were similar to traditional model group except that integrated care model group had a significantly reduced unplanned feeding tube replacement rate . In conclusion , the clinical effectiveness of integrated care model among severly disabled LTCF residents is minimal and a further cost-effectiveness study is needed to promote optimal quality of care in this setting OBJECTIVE To assess effect of a complex , multidisciplinary intervention aim ed at reducing avoidable acute hospitalization of residents of residential aged care ( RAC ) facilities . DESIGN Cluster r and omized controlled trial . SETTING RAC facilities with higher than expected hospitalizations in Auckl and , New Zeal and , were recruited and r and omized to intervention or control . PARTICIPANTS A total of 1998 residents of 18 intervention facilities and 18 control facilities . INTERVENTION A facility-based complex intervention of 9 months ' duration . The intervention comprised gerontology nurse specialist (GNS)-led staff education , facility bench-marking , GNS resident review , and multidisciplinary ( geriatrician , primary -care physician , pharmacist , GNS , and facility nurse ) discussion of residents selected using st and ard criteria . MAIN OUTCOME MEASURES Primary end point was avoidable hospitalizations . Secondary end points were all acute admissions , mortality , and acute bed-days . Follow-up was for a total of 14 months . RESULTS The intervention did not affect main study end points : number of acute avoidable hospital admissions ( RR 1.07 ; 95 % CI 0.85 - \n Output:\n " }, { "from": "agent", "value": "Despite the heterogeneity of studies , there is limited evidence that interventions delivered by geriatrics-trained staff reduce hospitalisations in nursing home residents ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic population s. Using a combination , such as albendazole ( ALB ) to diethylcarbamazine ( DEC ) gives both macrofilaricidal and anti-helmintic activity . However , the safety of the combination versus DEC alone should be established in field studies in large population s prior to incorporation into national programmes . The present study compared the safety , tolerability , and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in population s living in two filariasis endemic villages in the district of Wardha in western India . The study was double blind , parallel group , and r and omized . Safety and tolerability study were studied in males and females older than 5 years . Safety was assessed by monitoring if adverse events ( AEs ) over 5 days affected daily acivities . Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe . Efficacy was evaluated by microfilaraemia ( Mf ) , immunochromatographic test ( ICT ) and ultrasonography ( USG ) at 0 , 3 , 6 , and 12 months of follow up . The efficacy study enrolled 103 male patients ( aged 18 - 50 years ) in microfilariae positive , clinical disease and asymptomatic , amicrofilaremic groups . There was no significant difference in efficacy between groups at 12 months . Within the Mf positive group , significant differences were seen in microfilaraemia ( P < 0.001 ) with both treatments , and in USG ( P < 0.001 and P < 0.004 respectively ) , at 12 months . The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes . Both drugs were adequately absorbed . The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up . While the safety of the combination has been ascertained , the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up This r and omized , placebo-controlled trial investigated the efficacy and nutritional benefit of combining chemotherapeutic treatment for intestinal helminths ( albendazole ) and lymphatic filariasis ( ivermectin ) . Children were infected with Ascaris ( 29.2 % ) , Trichuris ( 42.2 % ) , and hookworm ( 6.9 % ) , with 54.7 % of children having one or more of these parasites . Wuchereria bancrofti microfilaria were found in 13.3 % of the children . Children were r and omly assigned to treatment with placebo , albendazole , ivermectin , or combined therapy . Combination treatment reduced the prevalence of Trichuris infections significantly more than either drug alone . Combination therapy also significantly reduced the prevalence and density of W. bancrofti microfilaremia compared with placebo or ivermectin alone . Only combination therapy result ed in significantly greater gains in height ( hookworm-infected children ) or weight ( Trichuris-infected children ) compared with the placebo group . Combined albendazole and ivermectin was a more efficacious treatment for intestinal helminth and W. bancrofti infections in children and result ed in nutritional benefits not found with either drug alone The efficacy of two strategies for control of Bancroftian filariasis using selective rather than community-wide diethylcarbamazine ( DEC ) chemotherapy was evaluated and compared in two endemic communities of north-eastern Tanzania , with pretreatment microfilariae ( mf ) prevalences of 22 % and 38 % , and geometric mean intensities ( GMIs ) of 668 mf/ml and 735 mf/ml of blood . All mf-positive cases in the first community were offered treatment with 6 mg of DEC/kg of body weight a day for 12 days ( group 1 ) , and those in the second community were offered treatment with two doses of 6 mg of DEC/kg of body weight at an interval of six months ( group 2 ) . The effect of treatment was followed both among those treated and at the community level . In treated individuals , there was a rapid decrease in the mf load that was significantly greater among those receiving the 12-day st and ard dose . One year after the start of treatment , the mf clearance rates were 59 % and 39 % and the GMIs were reduced by 99 % and 97 % among treated individuals in groups 1 and 2 , respectively . However , at the community level , the mf prevalences were 16.3 % and 27.9 % ( reduced by 27 % and 26 % ) and the GMIs were 129 mf/ml and 224 mf/ml ( reduced by 81 % and 70 % ) one year after the start of treatment with the two regimens , respectively , suggesting that transmission continued at a significant level in the villages after treatment . The limitations of selective chemotherapy are discussed , and it is argued that strategies based on mass DEC chemotherapy would be more effective in reducing the microfilarial load in the community and thereby in reducing transmission Forty male Polynesian W. bancrofti carriers with mf counts greater than or equal to 20/ml were treated with a single ivermectin 50 , 100 , 150 or 200 mcg/kg dose . Following therapy , mf levels fell to less than 1 % of pretreatment levels in the carriers treated with the 3 highest doses . After one month , negativation rate was 40 % in patients treated with a 50 mcg/kg dose , significantly lower than in patients treated with higher doses . Recurrence of microfilaremia was observed by 3 months , mf recurrence percentages were significantly lower in patients treated with the 3 highest doses than in patients treated with a 50 mcg/kg dose . At 6 months , mf recurrence percentages reached 49.8 , 12.6 , 14 and 5.4 % of pretreatment levels in carriers treated with 50 , 100 , 150 and 200 mcg/kg , respectively . No significant difference was observed between mf levels by group at 6 and 12 months . With respect to efficacy , a dose greater than or equal to 100 mcg/kg appeared superior to 50 mcg/kg dose ; no significant difference between the 3 highest doses was observed . Some patients developed headache , myalgia and fever within 24 hours following therapy , none of adverse reactions were considered serious . In vector Ae . polynesiensis fed on carriers 6 months after treatment , average numbers of mf ingested and average numbers of L3 cephalic larvae were lower than those observed in mosquitoes fed on non-treated carriers with comparable mf counts . ( ABSTRACT TRUNCATED AT 250 WORDS In a ' blinded ' trial ( in Sri Lanka , 1996 - 98 ) of 47 male asymptomatic microfilaraemic subjects with Wuchereria bancrofti infection , the safety , tolerability and filaricidal efficacy of 3 single-dose combination regimens were compared : albendazole 400 mg with ivermectin 200 micrograms/kg , albendazole 400 mg with diethylcarbamazine citrate ( DEC ) 6 mg/kg or albendazole 600 mg with ivermectin 400 micrograms/kg . Treated subjects were followed-up for 24 months . This represents the first long-term study using combinations of albendazole with DEC or ivermectin in the above doses against bancroftian filariasis . All subjects had pre-treatment microfilaria ( mf ) counts over 100/mL. All 3 treatments significantly reduced mf counts , with the albendazole-DEC-treated group showing the lowest mf levels at 18 and 24 months post-treatment . Filarial antigen tests suggested that all 3 treatments had significant activity against adult W. bancrofti ; albendazole-DEC combination had the greatest activity according to this test , with antigen levels decreasing to 30.5 % of pre-treatment antigen levels , 24 months after therapy . All 3 treatments were clinical ly safe and well tolerated . These results suggest that a single dose of albendazole 400 mg together with DEC 6 mg/kg is a safe and effective combination for suppression of microfilaraemia of bancroftian filariasis that could be considered for use in filariasis control programmes based on mass treatment of endemic population This r and omized , placebo-controlled trial investigated the tolerance , efficacy , and nutritional benefit of combining chemotherapeutic treatment of intestinal helminths and lymphatic filariasis . Children were infected with Ascaris ( 30.7 % ) , Trichuris ( 53.4 % ) , and hookworm ( 9.7 % ) with 69.9 % having more than one of these parasites . A total of 15.8 % of the children had Wuchereria bancrofti microfilariae . Children were r and omly assigned treatment with placebo , albendazole ( ALB ) , diethylcarbamazine ( DEC ) , or combined therapy . The combination of DEC/ALB reduced microfilarial density compared with placebo , ALB , or DEC ( P < or = 0.03 ) . Albendazole and DEC/ALB reduced the prevalence of Ascaris , Trichuris , and hookworm more than placebo or DEC ( P < or = 0.03 ) . Among Trichuris-infected children , those receiving ALB and DEC/ALB demonstrated greater gains in weight compared with placebo ( P < or = 0.05 ) . Albendazole and DEC/ALB were equally efficacious in treating intestinal helminths and for children with W. bancrofti microfilaremia , DEC/ALB was more effective than DEC , with no increase in severity of adverse reactions Several new chemotherapeutic tools are now available for the control of lymphatic filariasis . Combinations of single doses of antifilarial drugs are generally superior to single drugs . The efficacy and safety of albendazole in combination with diethylcarbamazine ( DEC ) or ivermectin , for the treatment of Brugia malayi infection , were investigated , for the first time , in an open , hospital-based study . Fifty-one asymptomatic microfilaraemics ( with 108 - 4034 microfilariae/ml ; median = 531 ) of both sexes and aged 14 - 70 years were r and omly allocated to receive single-dose treatments of ivermectin ( 200 micrograms/kg ) with diethylcarbamazine ( DEC ; 6 mg/kg ) , ivermectin ( 200 micrograms/kg ) with albendazole ( 400 mg ) , DEC ( 6 mg/kg ) with albendazole ( 400 mg ) , or albendazole ( 400 mg ) alone . Albendazole alone had no effect on the microfilarial levels at the 1-year follow-up but both groups given DEC had significantly lower microfilaraemias ( P < 0.015 and P < 0.02 ) than that given ivermectin with albendazole . Overall , 47%-64 % of those given DEC but only 14 % of those given ivermectin with albendazole appeared to be amicrofilaraemic 1 year post-treatment . The adverse reactions seen in the study were mild , transient and qualitatively similar to those seen earlier with ivermectin and DEC . The combination of DEC and albendazole , both well tested drugs , offers a new option for countries such as India where there is no onchocerciasis or loiasis and where ivermectin may not be immediately available . The direct and indirect effects of albendazole on intestinal helminths would be additional benefits The efficacy of re-treatment with the combination of ivermectin ( 150 - 200 micrograms/kg bodyweight ) and albendazole ( 400 mg ) on Wuchereria bancrofti microfilaraemia was assessed in 1997 - 99 in 4 groups of individuals from coastal Ghana , which 1 year previously had received a primary treatment with placebo ( n = 38 ) , albendazole ( n = 39 ) , ivermectin ( n = 34 ) or combination of albendazole and ivermectin ( n = 42 ) , respectively . One year after the re-treatment , an overall mean reduction in microfilarial intensity of 76.2 % in relation to the intensity before re-treatment was observed , with no statistical significant difference between the 4 groups . The groups given primary treatment with placebo or the drug combination showed re-treatment reductions which were lower ( 72.5 % and 69.8 % , respectively ) but not statistically significantly different from the reduction observed 1 year after the primary treatment with the combination ( 86.7 % ) . The efficacy of the combination treatment thus appeared to be largely independent of the type of primary treatment given and multiplicative when used repeatedly To assess the efficacy of diethylcarbamazine ( DEC ) in clearing Wuchereria bancrofti microfilariae ( mf ) from the circulation , we conducted a single blind hospital-based therapeutic trial of 3 DEC regimens . All patients were assessed by filtration of 1 mL of venous blood taken before and 1 , 3 , 6 and \n Output:\n " }, { "from": "agent", "value": "AUTHORS ' CONCLUSIONS There is insufficient evidence to confirm or refute that albendazole co-administered with DEC or ivermectin is more effective than DEC or ivermectin alone in clearing microfilariae or killing adult worms .\nAlbendazole combined with ivermectin appears to have a small effect on microfilaraemia , but this was not consistently demonstrated ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The minimum local analgesic concentration ( MLAC ) has been defined as the median effective local analgesic concentration ( EC50 ) in a 20-ml volume for epidural analgesia in the first stage of labor . The aim of this study was to determine the relative local anesthetic sparing efficacies of intravenous and epidural fentanyl by comparison of their effects on the MLAC of bupivacaine . Methods In this double-blind , r and omized , prospect i ve study , 84 parturients at ≤ 7-cm cervical dilation who requested epidural analgesia were allocated to one of two groups . After lumbar epidural catheter placement , 20 ml bupivacaine ( n = 44 ) or bupivacaine with 3 & mgr;g/ml ( 60 & mgr;g ) fentanyl ( n = 40 ) was administered . The plain bupivacaine group then received 60 & mgr;g intravenous fentanyl . The bupivacaine – fentanyl group received intravenous saline . The concentration of bupivacaine was determined by the response of the previous patient in that group to a higher or lower concentration using up – down sequential allocation . Analgesic efficacy was assessed using 100-mm visual analog pain scores , with ≤ 10 mm within 30 min defined as effective . Results The MLAC of bupivacaine – intravenous fentanyl was 0.064 % wt/vol ( 95 % confidence interval , 0.049–0.080 ) , and the MLAC of bupivacaine – epidural fentanyl was 0.034 % wt/vol ( 95 % confidence interval , 0.017–0.050 ) . Epidural fentanyl significantly increased the analgesic potency of bupivacaine by a factor of 1.88 ( 95 % confidence interval , 1.09–3.67 ) compared with intravenous fentanyl . The epidural fentanyl group demonstrated significantly higher dermatomal spread ( P = 0.0064 ) and increased pruritus ( P = 0.01 ) . Conclusions Epidural fentanyl significantly reduced the MLAC of bupivacaine when compared with intravenous fentanyl for the parturients in this study . The significantly enhanced local anesthetic sparing , dermatomal level , and pruritus with epidural fentanyl suggest a primarily spinal site of action OBJECTIVE To evaluate the effects of epidural analgesia using 0.2 % Ropivacaine on the mother , newborn and during labor . METHODS This study was conducted at the Zeynep Kamil Obstetric , Gynecology , and Pediatric Research and Training Hospital in Istanbul , Turkey , between July 2003 and April 2004 . Eighty pregnant women of 37 - 41 weeks ' gestation were enrolled in the study . Forty cases received epidural analgesia ( group 1 ) and the control group composed 40 cases ( group 2 ) . Duration of labor , systolic and diastolic blood pressures at initial , 15th , 30th , 45th and 60th minutes , and number of breathing per minute , pulse rates , fetal heart rates and presence of motor block were recorded . Blood gas assessment s from the umbilical cord , 1st and 5th minute Apgar scores were noted following the delivery . Way of delivery , adverse effects and complications of the epidural analgesia were recorded . RESULTS Mean age of the cases was 24.79 + /- 4.72 years . Duration between full cervical dilation and delivery ( phase 2 ) was significantly longer in group 1 ( p<0.01 ) . Sixty minutes systolic arterial pressure was significantly lower in group 1 ( p<0.05 ) . In group 1 , diastolic arterial pressures at 15th , 45th , 60th minutes ( p<0.01 ) and 30th minute ( p<0.05 ) were significantly lower when compared to the initial values . No significant differences were recorded in terms of breathing rates , umbilical cord CO2 , O2 , pH levels and Apgar scores between the 2 groups . The most common adverse effect of epidural analgesia was sedation ( 59 % ) . The second dose of Ropivacaine was needed in 24 ( 61.5 % ) cases in group 1 . In group 1 , 29 ( 74.4 % ) patients expressed their pleasure as very good regarding the epidural analgesia . CONCLUSION Epidural analgesia , if administered by a specialist to a properly selected patient at proper time , leads to a comfortable delivery by relieving the pain . It can be performed safely after taking an informed consent Purpose Epidural analgesia is associated with hyperthermia during labor and presumably causes it , although no convincing mechanism has been postulated . It seems likely that fever associated with pyrogenic factors related to labor is suppressed by opioids , whereas it is expressed normally in patients given epidural analgesia . We examined this hypothesis and the possible etiology of temperature elevation in labor . Methods In this prospect i ve , r and omized , controlled study , we assessed 201 parturients during spontaneous labor . Analgesia was r and omly provided with one of four treatment groups : ( 1 ) epidural ropivacaine alone , ( 2 ) IV remifentanil alone , ( 3 ) epidural ropivacaine plus IV remifentanil , and ( 4 ) epidural ropivacaine plus IV acetaminophen . At r and omization , patients were normothermic . Intrapartum hyperthermia ( ≥38 ° C ) was correlated to the analgesic technique . Results The maximum increase in oral temperature was greatest in the ropivacaine group ( 0.7 ± 0.6 ° C ) and least in the remifentanil group ( 0.3 ± 0.4 ° C ; P = 0.013 ) . The percentage of patients who became hyperthermic ( ≥38 ° C ) during the first 6 h of labor was greatest in the ropivacaine group ( 14 % ) and least in the remifentanil-alone group ( 2 % ) , but the difference was not statistically significant . The maximum forearm-finger gradients were lower ( less vasoconstriction ) in the remifentanil group when compared to the gradients in patients with epidural analgesia ( 1.4 ± 1.8 vs 3.0 ± 1.7 , respectively ; P < 0.001 ) . Conclusion Our results are consistent with the theory that low-dose opioids inhibit fever in patients not given epidural analgesia . However , in view of the negative results , the hypothesis of epidural-induced hyperthermia may be question able Background Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries . However , only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery . The authors ' primary purpose in this r and omized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative : patient-controlled intravenous analgesia . Methods Seven hundred fifteen women of mixed parity in spontaneous labor at full term were r and omly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia . Epidural analgesia was maintained with a continuous epidural infusion of 0.125 % bupivacaine with 2 micro gram/ml fentanyl . Patient-controlled analgesia was maintained with 10 - 15 mg meperidine given every 10 min as needed using a patient-controlled pump . Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman r and omized in the study . Results A total of 358 women were r and omized to receive epidural analgesia , and 243 ( 68 % ) of these women complied with the epidural analgesia protocol . Similarly , 357 women were r and omized to receive patient-controlled intravenous meperidine analgesia , and 259 ( 73 % ) of these women complied with the patient-controlled intravenous analgesia protocol . Only five women who were r and omized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief . There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original r and omization ( epidural analgesia , 4 % [ 95 % CI : 1.9 - 6.2 % ] compared with patient-controlled intravenous analgesia , 5 % [ 95 % CI : 2.6 - 7.2 % ] ) . Similar results were observed for the analysis of the protocol -compliant groups ( epidural analgesia , 5 % [ 95 % CI : 2.6 - 8.5 % ] compared with patient-controlled intravenous analgesia , 6 % [ 95 % CI : 3 - 8.9 % ] ) . Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia . Conclusions Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia OBJECTIVE To estimate the effect of epidural analgesia on the Friedman labor curve . METHODS This study was a secondary analysis of a previously reported r and omized trial of the effects of patient‐controlled epidural analgesia during labor compared with patient‐controlled meperidine on cesarean delivery rate . All subjects had a singleton , cephalic , nonanomalous fetus at or beyond 37 weeks ' gestation . This secondary analysis was limited to women who had cervical dilatation commencing of at least 3 cm ( ie , active phase of labor ) . RESULTS A total of 459 women were r and omized . Twenty‐five women were excluded for a cervix less than 3 cm dilated , leaving 220 women allocated to patient‐controlled epidural analgesia and 214 to patient‐controlled intravenous meperidine available for analysis . There were no significant demographic differences between the two groups , including age , race , gestational age , and cervix on admission . The active phase of labor was 1 hour longer in the epidural‐treated group ( 6.0 ± 3.2 hours versus 5.0 ± 3.2 hours , P < .001 ) . The rate of cervical dilation was significantly less with epidural analgesia ( 1.4 cm/h versus 1.6 cm/h , P < .002 ) . The duration of the second stage tended to be longer in the epidural group ( 1.1 ± 1.5 hours versus 0.9 ± 1.0 hours , P = .079 ) . CONCLUSION Epidural analgesia prolonged the active phase of labor by 1 hour compared with Friedman 's original criteria Background Pain relief during labour is a topic of major interest in the Netherl and s. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice . However its uptake by pregnant women is limited compared to other western countries , partly as a result of non-availability due to logistic problems . Remifentanil , a synthetic opioid , is very suitable for patient controlled analgesia . Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score ; however there was no difference in satisfaction with pain relief between both treatments . Methods / design The proposed study is a multicentre r and omized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia . We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia , with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia . Eligible women will be informed about the study and r and omized before active labour has started . Women will be r and omly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour . Primary outcome is the pain appreciation score , i.e. satisfaction with pain relief . Secondary outcome parameters are costs , patient satisfaction , pain scores ( pain-intensity ) , mode of delivery and maternal and neonatal side effects . The economic analysis will be performed from a short-term healthcare perspective . For both strategies the cost of perinatal care for mother and child , starting at the onset of labour and ending ten days after delivery , will be registered and compared . Discussion This study , considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia , could strongly improve the care for 180.000 women , giving birth in the Netherl and s yearly by giving them access to pain relief during labour , 24 hours a day . Trial registration numberDutch Trial Register NTR2551 , Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic . Our study was conducted to answer the question : does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population ? Method 395 healthy , nulliparous women , at term , presented in spontaneous labor with a singleton vertex presentation . These patients were r and omized to receive analgesia either , epidural with bolus doses of 1 % lidocaine or intravenous , with meperidine 25 to 50 mg when their cervix was dilated to 4 \n Output:\n " }, { "from": "agent", "value": "Side effects were reported in both epidural and opioid groups .\nWomen with epidural experienced more hypotension , motor blockade , fever , and urinary retention .\nThey also had longer first and second stages of labour , and were more likely to have oxytocin augmentation than the women in the opioid group .\nWomen receiving epidurals had less risk of respiratory depression requiring oxygen , and were less likely to experience nausea and vomiting than women receiving opioids .\nBabies born to women in the epidural group were less likely to have received naloxone .\nThere was no clear difference between groups for postnatal depression , headache , itching , shivering , or drowsiness .\nEpidural analgesia result ed in less reported pain when compared with placebo or no treatment , and with acu-stimulation .\nPain intensity was not reported in the trials that compared epidural with inhaled analgesia , or continuous support .\nAUTHORS ' CONCLUSIONS Low- quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods .\nAlthough overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia , a post hoc subgroup analysis showed this effect is not seen in recent studies ( after 2005 ) , suggesting that modern approaches to epidural analgesia in labour do not affect this outcome .\nEpidural analgesia had no impact on the risk of caesarean section or long-term backache , and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Heart failure ( HF ) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality . With an aging population , the cost associated with managing HF is expected to more than double from US $ 31 billion in 2012 to US $ 70 billion by 2030 . Readmission rates for HF patients are high—25 % are readmitted at 30 days and nearly 50 % at 6 months . Low medication adherence contributes to poor HF management and higher readmission rates . Remote telehealth monitoring programs aim ed at improved medication management and adherence may improve HF management and reduce readmissions . Objective The primary goal of this r and omized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program . We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department ( ED ) visits , increased medication adherence , and improved health-related quality of life ( HRQoL ) compared to usual care . Methods Participants were r and omized to usual care or use of the remote medication monitoring system for 90 days . Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants . Participants completed question naires at enrollment and closeout to gather data on medication adherence , health status , and HRQoL. Electronic medical records were review ed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period . Results Use of the medication monitoring system was associated with an 80 % reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care . Objective device data indicated high adherence rates ( 95%-99 % ) among intervention group participants despite finding no significant difference in self-reported adherence between study arms . The intervention group had poorer heart function and HRQoL at baseline , and HRQoL declined significantly in the intervention group compared to controls . Conclusions The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation . The MedSentry medication monitoring system may be useful both as a st and alone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions . We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls . Although HRQoL deteriorated significantly in the intervention group , this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls . Telehealth medication adherence technologies , such as the MedSentry medication monitoring system , are a promising method to improve patient self-management , the quality of patient care , and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens . Trial Registration Clinical Trials.gov NCT01814696 ; https:// clinical trials.gov/ct2/show/ study /NCT01814696 ( Archived by WebCite ® at http://www.webcitation.org/6giqAVhno Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design Care transitions from the hospital to home remain a vulnerable time for many patients , especially for those with heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) . Despite regular use in chronic disease management , it remains unclear how technology can best support patients during their transition from the hospital . We sought to evaluate the impact of a technology-supported care transition support program on hospitalizations , days out of the community and mortality . Using a pragmatic r and omized trial , we enrolled patients ( 511 enrolled , 478 analyzed ) hospitalized with CHF/ COPD to “ E-Coach , ” an intervention with condition-specific customization and in-hospital and post-discharge support by a care transition nurse ( CTN ) , interactive voice response post-discharge calls , and CTN follow-up versus usual post-discharge care ( UC ) . The primary outcome was 30-day rehospitalization . Secondary outcomes included ( 1 ) rehospitalization and death and ( 2 ) days in the hospital and out of the community . E-Coach and UC groups were similar at baseline except for gender imbalance ( p = 0.02 ) . After adjustment for gender , our primary outcome , 30-day rehospitalization rates did not differ between the E-Coach and UC groups ( 15.0 vs. 16.3 % , adjusted hazard ratio [ 95 % confidence interval ] : 0.94 [ 0.60 , 1.49 ] ) . However , in the COPD subgroup , E-Coach was associated with significantly fewer days in the hospital ( 0.5 vs. 1.6 , p = 0.03 ) . E-Coach , an IVR-augmented care transition intervention did not reduce rehospitalization . The positive impact on our secondary outcome ( days in hospital ) among COPD patients , but not in CHF , may suggest that E-Coach may be more beneficial among patients with COPD .NIH trial registry number : NCT01135381Trial Protocol : Background Comorbidity remains a matter of international interest , given growing prevalence of chronic conditions . Objective To evaluate the impact that adding a telephone coaching intervention by a family physician to usual care has on reducing re source consumption and improving health status , caregiver burden and quality of life among complex chronic patients ( CCP ) compared with usual care . Methods A r and omized controlled trial was conducted on a r and om sample of CCP from three primary care teams in Barcelona . Patients were r and omly allocated into intervention or control groups . Evaluations were conducted at baseline and after six-month follow-up . Intervention patients were phoned twice a month by a family physician . Both groups received usual care . Primary endpoint was change in total number of urgent visits per patient . Secondary endpoints were changes in health and mental status , quality of life and caregiver burden . Results Hundred and sixty-one CCP were included . During follow-up , 9 patients died and 2 were lost . At baseline , patients ' characteristics and re source consumption were similar for both groups . After six months , urgent visits per patient decreased in intervention ( 1.27 baseline versus 0.89 follow-up , P = 0.091 ) and control ( 1.06 baseline versus 0.86 follow-up , P = 0.422 ) groups , mean difference 0.18 [ confidence interval ( CI ) 95 % -0.48 to 0.84 ] . Intervention patients improved in the physical component of the SF-12 question naire , while worsening in control patients , mean difference 4.71 ( CI 95 % -9.03 to -0.41 ) . Differences were not found in the rest of the endpoints . Conclusion The intervention did not reduce urgent visits among CCP neither improved patient 's health Background Antiretroviral therapy has changed the natural history of human immunodeficiency virus ( HIV ) infection in developed countries , where it has become a chronic disease . This clinical scenario requires a new approach to simplify follow-up appointments and facilitate access to healthcare professionals . Methodology We developed a new internet-based home care model covering the entire management of chronic HIV-infected patients . This was called Virtual Hospital . We report the results of a prospect i ve r and omised study performed over two years , comparing st and ard care received by HIV-infected patients with Virtual Hospital care . HIV-infected patients with access to a computer and broadb and were r and omised to be monitored either through Virtual Hospital ( Arm I ) or through st and ard care at the day hospital ( Arm II ) . After one year of follow up , patients switched their care to the other arm . Virtual Hospital offered four main services : Virtual Consultations , Telepharmacy , Virtual Library and Virtual Community . A technical and clinical evaluation of Virtual Hospital was carried out . Findings Of the 83 r and omised patients , 42 were monitored during the first year through Virtual Hospital ( Arm I ) and 41 through st and ard care ( Arm II ) . Baseline characteristics of patients were similar in the two arms . The level of technical satisfaction with the virtual system was high : 85 % of patients considered that Virtual Hospital improved their access to clinical data and they felt comfortable with the videoconference system . Neither clinical parameters [ level of CD4 + T lymphocytes , proportion of patients with an undetectable level of viral load ( p = 0.21 ) and compliance levels > 90 % ( p = 0.58 ) ] nor the evaluation of quality of life or psychological question naires changed significantly between the two types of care . Conclusions Virtual Hospital is a feasible and safe tool for the multidisciplinary home care of chronic HIV patients . Telemedicine should be considered as an appropriate support service for the management of chronic HIV infection . Trial Registration Clinical -Trials.gov : NCT01117675 Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203 Background . Policy makers require estimates of comparative effectiveness that apply to the population of interest , but there has been little research on quantitative approaches to assess and extend the generalizability of r and omized controlled trial ( RCT ) –based evaluations . We illustrate an approach using observational data . Methods . Our example is the Whole Systems Demonstrator ( WSD ) trial , in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care . First , we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of non participants who received usual care . We matched on 65 baseline variables obtained from the electronic medical record . Second , we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether “ usual care ” is defined by the RCT control group or non participants . Thus , we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched non participants . Results . For some endpoints , such as the number of outpatient attendances , the placebo tests passed , and the effectiveness estimates were robust to the choice of comparison group . However , for other endpoints , such as emergency admissions , the placebo tests failed and the estimates of treatment effect differed markedly according to whether telehealth patients were compared with RCT controls or matched non participants . Conclusions . The proposed placebo tests indicate those cases when estimates from RCTs do not generalize to routine clinical practice and motivate complementary estimates of comparative effectiveness that use observational data . Future RCTs are recommended to incorporate these placebo tests and the accompanying sensitivity analyses to enhance their relevance to policy making OBJECTIVE With the advent of personal health records and other patient-focused health technologies , there is a growing need to better underst and factors that contribute to acceptance and use of such innovations . In this study , we employed the Unified Theory of Acceptance and Use of Technology as the basis for determining what predicts patients ' acceptance ( measured by behavioral intention ) and perceived effective use of a web-based , interactive self-management innovation among home care patients . DESIGN Cross-sectional secondary analysis of data from a r and omized field study evaluating a technology-assisted home care nursing practice with adults with chronic cardiac disease . MEASUREMENT AND ANALYSIS : A question naire was design ed based on vali date d measurement scales from prior research and was completed by 101 participants for measuring the acceptance constructs as part of \n Output:\n " }, { "from": "agent", "value": "The 34 articles selected identified virtual support , telephone monitoring and electronic devices as the main characteristics of tele-nursing ; the patient 's profile ( not young , with a low socio-economic and educational level ) and the resistance of the nursing professionals were the barriers identified ; while the new technological age was identified as a factor facilitating its implementation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose : All patients with EGF receptor (EGFR)–mutant lung cancers eventually develop acquired resistance to EGFR tyrosine kinase inhibitors ( TKI ) . Smaller series have identified various mechanisms of resistance , but systematic evaluation of a large number of patients to definitively establish the frequency of various mechanisms has not been conducted . Experimental Design : Patients with lung adenocarcinomas and acquired resistance to erlotinib or gefitinib enrolled onto a prospect i ve biopsy protocol and underwent a rebiopsy after the development of acquired resistance . Histology was review ed . Sample s underwent genotyping for mutations in EGFR , AKT1 , BRAF , ERBB2 , KRAS , MEK1 , NRAS and PIK3CA , and FISH for MET and HER2 . Results : Adequate tumor sample s for molecular analysis were obtained in 155 patients . Ninety-eight had second-site EGFR T790 M mutations [ 63 % ; 95 % confidence interval ( CI ) , 55%–70 % ] and four had small cell transformation ( 3 % , 95 % CI , 0%–6 % ) . MET amplification was seen in 4 of 75 ( 5 % ; 95 % CI , 1%–13 % ) . HER2 amplification was seen in 3 of 24 ( 13 % ; 95 % CI , 3%–32 % ) . We did not detect any acquired mutations in PIK3CA , AKT1 , BRAF , ERBB2 , KRAS , MEK1 , or NRAS ( 0 of 88 , 0 % ; 95 % CI , 0%–4 % ) . Overlap among mechanisms of acquired resistance was seen in 4 % . Conclusions : This is the largest series reporting mechanisms of acquired resistance to EGFR-TKI therapy . We identified EGFR T790 M as the most common mechanism of acquired resistance , whereas MET amplification , HER2 amplification , and small cell histologic transformation occur less frequently . More comprehensive methods to characterize molecular alterations in this setting are needed to improve our underst and ing of acquired resistance to EGFR-TKIs . Clin Cancer Res ; 19(8 ) ; 2240–7 . © 2013 AACR Purpose : Somatic mutations in the epidermal growth factor receptor ( EGFR ) have been detected in patients with non – small cell lung cancer ( NSCLC ) and are associated with sensitivity to treatment with gefitinib or erlotinib . Our study explored the relationship between the two most common types of somatic EGFR mutations , exon 19 deletions and the L858R point mutation , and outcomes of patients following treatment with gefitinib or erlotinib . Experimental Design : Tumor specimens obtained before treatment with gefitinib or erlotinib were analyzed for EGFR mutations . Patients with exon 19 deletion or L858R mutations were identified . The response rate , time to progression , and overall survival were determined for the two groups . Results : We identified 36 patients with NSCLC and an EGFR mutation who were treated with gefitinib or erlotinib . Patients with an exon 19 deletion had a significantly longer overall survival compared with patients with an L858R mutation ( 38 versus 17 months ; P = 0.04 ) . There were also trends toward higher response rate ( 73 % versus 50 % ) and improved time to progression ( 24 versus 10 months ) for the patients with an exon 19 deletion , although these were not independently significant in a multivariate analysis . A difference in response rate for patients treated with gefitinib compared with erlotinib was also noted [ 18 of 23 ( 78 % ) versus 3 of 9 ( 33 % ) ; P = 0.04 ] . No obvious difference in time to progression or overall survival was noted between gefitinib- and erlotinib-treated patients . Conclusions : Patients with NSCLC and EGFR exon 19 deletions have a longer survival following treatment with gefitinib or erlotinib compared with those with the L858R mutation . Pooling of greater numbers of patients and completion of prospect i ve trials are needed to further define the predictive and prognostic roles of different EGFR mutations with respect to treatment with gefitinib , erlotinib , and other EGFR inhibitors This study was design ed to prospect ively evaluate the efficacy and safety of first-line gefitinib treatment in patients with advanced pulmonary adenocarcinoma harboring epidermal growth factor receptor ( EGFR ) mutations and to explore the molecular factors affecting the efficacy of gefitinib . Tumor tissue , derived from either the original tumor or the metastatic or recurrent site was taken from chemo-naïve pts with advanced ( stage IIIB , IV , and recurrent ) pulmonary adenocarcinoma . Tumor genomic DNA underwent direct sequencing for EGFR exons 18 , 19 , 20 , and 21 . Patients with EGFR mutations received 250 mg of gefitinib daily until disease progression or unacceptable toxicity . The primary endpoint was objective response rate ( ORR ) . Secondary endpoints were progression free survival ( PFS ) , overall survival ( OS ) and tolerability . Out of 147 screened patients , 45 pts ( 31 % ) had EGFR mutations and received gefitinib . The most common EGFR mutations were in-frame exon 19 deletions ( 29 pts , 64 % ) and L858R point mutation in exon 21 ( 15 pts , 33 % ) . One patient had atypical mutation of L861Q in exon 21 . The ORR was 53.3 % ( 95 % CI , 38.6 - 67.9 ) and disease control rate ( DCR ) including stable disease was 86.7 % . The median progression free survival ( PFS ) was 398 days and the median overall survival ( OS ) was 819 days . Treatment was well tolerated . Grade 3/4 adverse events ( AEs ) were reported by 6 patients and treatment-related Grade 3 AEs by 3 patients . There were no treatment-related Grade 4 AEs . Exploratory subgroup analysis according to the EGFR mutation subtypes was carried out . The ORR and DCR were higher in patients with exon 19 deletions than those with L858R ( 62.1 % vs 33.3 % ; P=0.0705 and 96.6 % vs 66.7 % ; P=0.0062 , respectively ) . All 4 patients with progressive disease had a L858R mutation . No secondary resistant mutations such as T790 M mutation or insertions in exon 20 were found in those patients . In addition , OS was significantly better in patients with exon 19 deletions than those with L858R ( 24-month OS rate was 72.1 % vs 32.0 % , P=0.0148 ) . Gefitinib as the first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations was effective and well tolerated . Subgroup analysis suggests that the benefit from gefitinib treatment was more prominent in patients with the exon 19 deletion mutations ( Clinical Trials.gov number , NCT00344773 ) Purpose : Patients with epidermal growth factor receptor (EGFR)-mutant lung adenocarcinoma develop acquired resistance to EGFR tyrosine kinase inhibitors ( TKI ) after a median of 10 to 16 months . In half of these cases , a second EGFR mutation , T790 M , underlies acquired resistance . We undertook this study to examine the clinical course of patients harboring the T790 M mutation following progression on TKI . Experimental Design : EGFR-mutant lung cancer patients with acquired resistance to EGFR TKIs were identified as part of a prospect i ve rebiopsy protocol in which postprogression tumor specimens were collected for molecular analysis . Postprogression survival and characteristics of disease progression were compared in patients with and without T790 M . Results : We identified T790 M in the initial rebiopsy specimens from 58 of 93 patients ( 62 % , 95 % CI : 52–72 ) . T790 M was more common in biopsies of lung/pleura tissue and lymph nodes than in more distant sites ( P = 0.014 ) . Median postprogression survival was 16 months ( interquartile range = 9–29 months ) ; patients with T790 M had a significantly longer postprogression survival ( P = 0.036 ) . Patients without T790 M more often progressed in a previously uninvolved organ system ( P = 0.014 ) and exhibited a poorer performance status at time of progression ( P = 0.007 ) . Conclusions : Among patients with acquired resistance to EGFR TKIs , the presence of T790 M defines a clinical subset with a relatively favorable prognosis and more indolent progression . Knowledge of T790 M status is therefore important both for the clinical care of these patients and for the optimal design and interpretation of clinical trials in this setting . Clin Cancer Res ; 17(6 ) ; 1616–22 . © 2010 AACR Purpose : In patients with non – small cell lung cancer ( NSCLC ) , mutations in the epidermal growth factor receptor ( EGFR ) tyrosine kinase domain have been associated with sensitivity to erlotinib and gefitinib . We undertook this study to explore the relationship between EGFR mutation type and clinical variables , including treatment with gefitinib and erlotinib . Experimental Design : In patients with NSCLC , EGFR exon 19 deletion mutations and EGFR L858R point mutations were analyzed by nonsequencing PCR-based methods from paraffin blocks of tissue obtained before treatment . The results were correlated with clinical information ( sex , pathologic subtype , race/ethnicity , treatment , and overall survival ) . Results : The two most common EGFR mutations were identified in 24 % ( 70 of 291 ; 95 % confidence interval , 26%-38 % ) of tumors from patients with NSCLC . EGFR mutation was associated with Asian ethnicity ( P = 0.0023 ) and being a “ never smoker ” ( P = 0.0001 ) . Among patients with EGFR mutations , 39 % ( 27 of 70 ) had EGFR L858R , whereas 61 % ( 43 of 70 ) had an EGFR exon 19 deletion . After treatment with erlotinib ( n = 12 ) or gefitinib ( n = 22 ) , patients with EGFR mutations had a median overall survival of 20 months . After treatment with erlotinib or gefitinib , patients with EGFR exon 19 deletions had significantly longer median survival than patients with EGFR L858R ( 34 versus 8 months ; log-rank P = 0.01 ) . Conclusions : EGFR mutations in exons 19 or 21 are correlated with clinical factors predictive of response to gefitinib and erlotinib . Those with EGFR exon 19 deletion mutations had a longer median survival than patients with EGFR L858R point mutation . These observations warrant confirmation in a prospect i ve study and exploration of the biological mechanisms of the differences between the two major EGFR mutations BACKGROUND Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor ( TKI ) therapy in non-small-cell lung cancer ( NSCLC ) . The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus st and ard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC . METHODS We undertook an open-label , r and omised , phase 3 trial at 22 centres in China . Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR ( exon 19 deletion or exon 21 L858R point mutation ) received either oral erlotinib ( 150 mg/day ) until disease progression or unacceptable toxic effects , or up to four cycles of gemcitabine plus carboplatin . Patients were r and omly assigned ( 1:1 ) with a minimisation procedure and were stratified according to EGFR mutation type , histological subtype ( adenocarcinoma vs non-adenocarcinoma ) , and smoking status . The primary outcome was progression-free survival , analysed in patients with confirmed disease who received at least one dose of study treatment . The trial is registered at Clinical Trials.gov , number NCT00874419 , and has completed enrolment ; patients are still in follow-up . FINDINGS 83 patients were r and omly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin ; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint . Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy ( 13.1 [ 95 % CI 10.58 - 16.53 ] vs 4.6 [ 4.21 - 5.42 ] months ; hazard ratio 0.16 , 95 % CI 0.10 - 0.26 ; p<0.0001 ) . Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlot \n Output:\n " }, { "from": "agent", "value": "Conclusions T790 M occurred more frequently in patients with the exon 19 deletion than in those with exon 21 L858R , which gave the survival benefit of the T790 M mutation and may explain why patients with the exon 19 deletion had an improved overall survival" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : Bronchopulmonary dysplasia ( BPD ) is the focus of many intervention trials , yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians . Thus , we wished to define BPD by a st and ardized oxygen saturation monitoring at 36 weeks corrected age , and compare this physiologic definition with the st and ard clinical definition of BPD based solely on oxygen administration . METHODOLOGY : A total of 199 consecutive very low birthweight infants ( VLBW , 501 to 1500 g birthweight ) were assessed prospect ively at 36±1 weeks corrected age . Neonates on positive pressure support or receiving > 30 % supplemental oxygen were assigned the outcome BPD . Those receiving ≤30 % oxygen underwent a stepwise 2 % reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring . Outcomes of the test were “ no BPD ” ( saturations ≥88 % for 60 minutes ) or “ BPD ” ( saturation < 88 % ) . At the conclusion of the test , all infants were returned to their baseline oxygen . Safety ( apnea , bradycardia , increased oxygen use ) , inter-rater reliability , test – retest reliability , and validity of the physiologic definition vs the clinical definition were assessed . RESULTS : A total of 199 VLBW were assessed , of whom 45 ( 36 % ) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age . The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air . The physiologic definition diagnosed BPD in 30 ( 24 % ) of the cohort . All infants were safely studied . The test was highly reliable ( inter-rater reliability , κ=1.0 ; test – retest reliability , κ=0.83 ) and highly correlated with discharge home in oxygen , length of hospital stay , and hospital readmissions in the first year of life . CONCLUSIONS : The physiologic definition of BPD is safe , feasible , reliable , and valid and improves the precision of the diagnosis of BPD . This may be of benefit in future multicenter clinical trials OBJECTIVE To determine whether an earlier observation , that infants fed a casein-hydrolysate formula ( Nutramigen ) have lower neonatal jaundice levels than those fed st and ard formulas , would be repeated in a larger independent group of infants with more frequent measurements and more rigorous statistical analysis . DESIGN Newborn infants were fed human milk , a st and ard whey-predominant formula ( Enfamil ) , or Nutramigen ( n = 20 for each group ) during the first 3 weeks of life . Transcutaneous jaundice index was measured daily for the first week of life and every 2 to 3 days thereafter , using a noninvasive jaundice meter . Linear regression models of the data were constructed , vali date d , and compared statistically . SETTING General community hospital with subsequent home visitation . PARTICIPANTS Healthy , term newborn infants selected by convenience , based on time of birth . INTERVENTION Infants were exclusively fed human milk , Enfamil , or Nutramigen . Formulas were r and omly assigned . MAIN OUTCOME MEASURE Jaundice index , a transcutaneous measurement of jaundice . RESULTS The jaundice index differed significantly among the 3 groups . Paired comparisons showed that the jaundice index of the Nutramigen group was significantly lower than that of the Enfamil group ( on days 6 - 16 ) and the human milk group ( on days 3 - 20 ) . The jaundice index of the Enfamil-fed group was significantly lower than that of the human milk group on days 13 to 19 . CONCLUSIONS Jaundice levels are lower in neonates fed Nutramigen rather than Enfamil and both these groups have lower jaundice levels than breast-fed infants OBJECTIVE To evaluate the effectiveness of fluid supplementation in decreasing the rate of exchange transfusion and the duration of phototherapy in term neonates with severe nonhemolytic hyperbilirubinemia . STUDY DESIGN This was a r and omized controlled trial conducted in a tertiary care referral unit in northern India . Seventy-four term neonates with severe nonhemolytic hyperbilirubinemia ( total serum bilirubin > 18 mg/dL [ 308 micromol/L ] to < 25 mg/dL [ 427 micromol/L ] ) . The subjects were r and omized to an \" extra fluids \" group ( intravenous fluid supplementation for 8 hours and oral supplementation for the duration of phototherapy ; n = 37 ) or a control group ( n = 37 ) . RESULTS At inclusion , 54 infants ( 73 % ) had high serum osmolality , including 28 ( 75 % ) in the extra fluids group and 26 ( 70 % ) in the control group . The proportion of infants who underwent exchange transfusion was lower in the extra fluids group than in the control group : 6 ( 16 % ) versus 20 (54%)(P = .001 ; relative risk = 0.30 ; 95 % confidence interval = 0.14 to 0.66 ) . The duration of phototherapy was also shorter in the extra fluids group : 52 + /- 18 hours versus 73 + /- 31 hours ( P = .004 ) . CONCLUSION Fluid supplementation in term neonates presenting with severe hyperbilirubinemia decreased the rate of exchange transfusion and duration of phototherapy OBJECTIVE To compare the effectiveness of two methods of vascular access in newborns . DESIGN R and omized controlled trial . SETTING Neonatal intensive care unit in Regional Hospital of Valdivia , Chile . PARTICIPANTS Seventy-four high-risk newborns . INTERVENTIONS Peripherally inserted central catheter and peripheral intravenous catheter . MAIN OUTCOME MEASURES Length of neonatal intensive care unit stay and incidence of sepsis and phlebitis . RESULTS / DATA ANALYSIS : There were no statistically significant differences in the length of the neonatal intensive care unit stay and in the incidence of sepsis between groups . There was a significant higher incidence of phlebitis in the peripheral intravenous catheter group . CONCLUSIONS Although there was not a significant effect of the kind of catheter on length of neonatal intensive care unit stay , the peripherally inserted central catheter is recommended because of the decreased risk of phlebitis and the decreased number of venipuncture attempts and catheters needed to complete intravenous therapy Abstract Background : This study compared the rates of decrease in serum bilirubin levels in severely jaundiced healthy term infants given oral or intravenous fluid supplementation during phototherapy . Methods : A r and omized controlled study was carried out in the neonatal intensive care unit of Zeynep Kamil Maternity and Children Hospital ( Istanbul , Turkey ) over a 4-month period . Two hundred fifty healthy term infants with hyperbilirubinemia were r and omized to receive either solely breastmilk ( n=125 ) or both breastmilk and intravenous fluid ( n=125 ) during phototherapy . Results : There were no significant differences ( p>0.05 ) in the mean birth weight , mean gestastional age , modes of delivery , mean time of admission age , mean serum osmolality , and hematocrit and reticulocyte count between the two groups . Similarly , there was no significant difference ( p>0.05 ) in the mean indirect serum bilirubin level at the time of admission to the neonatal intensive care unit and at 4 , 8 , 12 , 24 , and 48 hours after commencement of phototherapy between the two groups . There was no significant difference ( p>0.05 ) in the mean duration of phototherapy or in the median duration of hospitalization between the two groups . Conclusions : Based on our results , intravenous fluid support has no effect on the rate of decrease in serum bilirubin and decrease in duration of phototherapy in healthy term newborns with no dehydratation . However , using the oral route avoided the need for intravenous cannulae and their attendant complications . Insensible fluid loss is increased during phototherapy , so protection of hydration status with oral feeding is important for newborns OBJECTIVE Our purpose was to evaluate the effect of breast-feeding frequency on serum bilirubin levels in the first 3 days after birth . STUDY DESIGN Two hundred seventy-five infants were r and omly assigned to a frequent or dem and breast-feeding schedule . RESULTS Infants in the frequent group ( n = 131 ) nursed nine ( 7.5 to 10.5 ) times per day ( median and inner 80 % ) , and the dem and group ( n = 143 ) fed 6.5 ( 5.5 to 8.0 ) times per day . The serum bilirubin level was measured in all infants between 48 and 80 hours ( median 53 hours , inner 80 % 48 to 68 hours ) and was 7.4 ( 1.8 to 10.7 ) mg/dl in the frequent group and 8.0 ( 2.9 to 11.2 ) mg/dl in the dem and group ( p = 0.103 ) . There was no correlation between the frequency of breast-feeding and the serum bilirubin level . CONCLUSION Within the range of the frequency of nursing observed in this study , we could not demonstrate a significant effect on serum bilirubin levels in the first 3 days after birth We measured the serum bilirubin concentrations in 2,416 consecutive infants admitted to our well-baby nursery . The maximum serum bilirubin concentration exceeded 12.9 mg/dL ( 221 mumol/L ) in 147 infants ( 6.1 % ) , and these infants were compared with 147 r and omly selected control infants with maximum serum bilirubin levels less than or equal to 12.9 mg/dL. In 66 infants ( 44.9 % ) , we identified an apparent cause for the jaundice , but in 81 ( 55 % ) , no cause was found . Of infants for whom no cause for hyperbilirubinemia was found , 82.7 % were breast-fed v 46.9 % in the control group ( P less than .0001 ) . Breast-feeding was significantly associated with hyperbilirubinemia , even in the first three days of life . The 95th percentile for bottle-fed infants is a serum bilirubin level of 11.4 mg/dL v 14.5 mg/dL for the breast-fed population , and the 97th percentiles are 12.4 and 14.8 mg/dL , respectively . Of the formula-fed infants , 2.24 % had serum bilirubin levels greater than 12.9 mg/dL v 8.97 % of breast-fed infants ( P less than .000001 ) . When compared with previous large studies , the incidence of \" readily visible \" jaundice ( serum bilirubin level greater than 8 mg/dL ) appears to be increasing . The dramatic increase in breast-feeding in the United States in the last 25 years may explain this observation . There is a strong association between breast-feeding and jaundice in the healthy newborn infant . Investigations for the cause of hyperbilirubinemia in healthy breast-fed infants may not be indicated unless the serum bilirubin level exceeds approximately 15 mg/dL , whereas in the bottle-fed infant , such investigations may be indicated if the serum bilirubin exceeds approximately 12 mg/dL. ( ABSTRACT TRUNCATED AT 250 WORDS Objectives : To determine the incidence of severe hyperbilirubinaemia in the newborn , and to identify associated clinical and demographic variables , and short-term outcomes . Design : Prospect i ve , population -based study . Setting : UK and Republic of Irel and , between 1 May 2003 and 31 May 2005 . Participants : Infants in the first month of life with severe hyperbilirubinaemia ( maximum unconjugated serum bilirubin ⩾510 & mgr;mol/l ) . Results : 108 infants met the case definition , 106 from the UK and 2 from the Republic of Irel and . The UK incidence of severe hyperbilirubinaemia was 7.1/100 000 live births ( 95 % CI 5.8 to 8.6 ) . Only 20 cases presented in hospital ; 88 were admitted with severe jaundice . 64 ( 60.4 % ) cases were male , and 56 ( 51.8 % ) were of ethnic minority origin . 87 ( 80.5 % ) cases were exclusively breast fed . Co-morbidity included haemolysis , dehydration , infection and bruising . 14 infants showed evidence of bilirubin encephalopathy , of whom 3 died . The UK incidence of bilirubin encephalopathy was 0.9/100 000 live births ( 95 % CI 0.46 to 1.5 ) . Conclusions : This is the first large , prospect i ve , population -based study of the incidence of severe hyperbilirubinaemia in the newborn . The clinical and demographic associations , and short-term outcomes identified , are the same as those reported recently in North America and Europe Thirty to 50 % of very low-b \n Output:\n " }, { "from": "agent", "value": "Beyond eight hours postintervention , serum bilirubin was similar between the two groups .\nAUTHORS ' CONCLUSIONS There is no evidence that IV fluid supplementation affects important clinical outcomes such as bilirubin encephalopathy , kernicterus , or cerebral palsy in healthy , term newborn infants with unconjugated hyperbilirubinaemia requiring phototherapy .\nIn this review , no infant developed these bilirubin-associated clinical complications .\nLow- to moderate- quality evidence shows that there are differences in total serum bilirubin levels between fluid-supplemented and control groups at some time points but not at others , the clinical significance of which is uncertain .\nThere is no evidence of a difference between the effectiveness of IV and oral fluid supplementations in reducing serum bilirubin .\nSimilarly , no infant developed adverse events or complications from fluid supplementation such as vomiting or abdominal distension ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND We have investigated the possible effects of contrasting ACE ( I/D ) genotypes on the responses to the ACE inhibitor enalaprilat in normotensive men . METHODS AND RESULTS Subjects with DD ( n=12 ) and II ( n=11 ) ACE genotypes received an intravenous infusion of enalaprilat or placebo . Pressor responses to stepwise , incremental doses of angiotensin I were measured at 1 and 10 hours after dosing . The dose required to raise mean blood pressure by 20 mm Hg ( PD20 ) was calculated individually , and the ratio of PD20 during enalaprilat to that during placebo ( dose ratio , DR ) was used for assessment of the extent of ACE inhibition . The pressor response was significantly attenuated at 1 hour after enalaprilat in both groups , but significant attenuation was evident at 10 hours after dose only in the II subjects . The DRs at both 1 hour ( median , 5.43 versus 2.82 , P=0.0035 ) and 10 hours ( 2.06 versus 0.84 , P=0.0008 ) after enalaprilat were significantly higher in II subjects than in DD subjects . CONCLUSIONS The effect of enalaprilat was significantly greater and lasted longer in normotensive men homozygous for the II ACE genotype . By multivariate analysis , ACE ( I/D ) genotype and plasma angiotensin II levels were predictive of > 50 % of the variation in response to ACE inhibition BACKGROUND It is unknown whether either the angiotensin-II-receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure . METHODS We r and omly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan ( 300 mg daily ) , amlodipine ( 10 mg daily ) , or placebo . The target blood pressure was 135/85 mm Hg or less in all groups . We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration , the development of end-stage renal disease , or death from any cause . We also compared them with regard to the time to a secondary , cardiovascular composite end point . RESULTS The mean duration of follow-up was 2.6 years . Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group ( P=0.02 ) and 23 percent lower than that in the amlodipine group ( P=0.006 ) . The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group ( P=0.003 ) and 37 percent lower in the irbesartan group than in the amlodipine group ( P<0.001 ) . Treatment with irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups ( P=0.07 for both comparisons ) . These differences were not explained by differences in the blood pressures that were achieved . The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group ( P=0.008 ) and 21 percent more slowly than in the amlodipine group ( P=0.02 ) . There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point . CONCLUSIONS The angiotensin-II-receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes . This protection is independent of the reduction in blood pressure it causes BACKGROUND Prehypertension is considered a precursor of stage 1 hypertension and a predictor of excessive cardiovascular risk . We investigated whether pharmacologic treatment of prehypertension prevents or postpones stage 1 hypertension . METHODS Participants with repeated measurements of systolic pressure of 130 to 139 mm Hg and diastolic pressure of 89 mm Hg or lower , or systolic pressure of 139 mm Hg or lower and diastolic pressure of 85 to 89 mm Hg , were r and omly assigned to receive two years of c and esartan ( Atac and , AstraZeneca ) or placebo , followed by two years of placebo for all . When a participant reached the study end point of stage 1 hypertension , treatment with antihypertensive agents was initiated . Both the c and esartan group and the placebo group were instructed to make changes in lifestyle to reduce blood pressure throughout the trial . RESULTS A total of 409 participants were r and omly assigned to c and esartan , and 400 to placebo . Data on 772 participants ( 391 in the c and esartan group and 381 in the placebo group ; mean age , 48.5 years ; 59.6 percent men ) were available for analysis . During the first two years , hypertension developed in 154 participants in the placebo group and 53 of those in the c and esartan group ( relative risk reduction , 66.3 percent ; P<0.001 ) . After four years , hypertension had developed in 240 participants in the placebo group and 208 of those in the c and esartan group ( relative risk reduction , 15.6 percent ; P<0.007 ) . Serious adverse events occurred in 3.5 percent of the participants assigned to c and esartan and 5.9 percent of those receiving placebo . CONCLUSIONS Over a period of four years , stage 1 hypertension developed in nearly two thirds of patients with untreated prehypertension ( the placebo group ) . Treatment of prehypertension with c and esartan appeared to be well tolerated and reduced the risk of incident hypertension during the study period . Thus , treatment of prehypertension appears to be feasible . ( Clinical Trials.gov number , NCT00227318 . ) The aim of this study was to investigate the relationship between polymorphism of the anglotensin-converting enzyme ( ACE ) gene and the blood pressure response to ACE inhibition in a hypertensive cohort . Imidapril ( 5 - 10 mg/day ) or benazepril ( 10 - 20 mg/day ) was administered for 6 weeks to 517 essential hypertensives . ACE gene polymorphism was examined by the polymerase chain reaction ( PCR ) method and the patients were classified as having the 190-bp deletion homozygous ( DD ) genotype , the 490-bp insertion homozygous ( II ) genotype , or the 490-bp insertion , 190-bp deletion heterozygous ( ID ) genotype . The achieved change in systolic and diastolic blood pressure ( SBP and DBP ) was analyzed for association with genotypes at the ACE gene locus . The DD genotype was observed in 132 patients ( 25.5 % ) , the ID genotype in 255 patients ( 49.3 % ) , and the II genotype in 130 patients ( 25.2 % ) . The SBP reductions in the patients with the DD genotype , II genotype , and ID genotype were -14.5 + /- 12.7 mmHg , -14.3 + /- 13.1 mmHg and -14.0 + /- 12.2 mmHg , respectively ( p = 0.94 ) . The DBP reductions in the patients with the DD genotype , II genotype , and ID genotype were -8.7 + /- 7.4 mmHg , -8.7 + /- 7.7 mmHg and -8.5 + /- 6.7 mmHg , respectively ( p = 0.96 ) . There was no significant association between the ACE gene polymorphisms and the response to ACE inhibition . These results suggest that ACE genotype does not predict the blood pressure-lowering response to antihypertensive treatment with ACE inhibition BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) and 29.1/16.8 mm Hg ( 19.2/10.1 ) in the losartan and atenolol groups , respectively . The primary composite endpoint occurred in 508 losartan ( 23.8 per 1000 patient-years ) and 588 atenolol patients ( 27.9 per 1000 patient-years ; relative risk 0.87 , 95 % CI 0.77 - 0.98 , p=0.021 ) . 204 losartan and 234 atenolol patients died from cardiovascular disease ( 0.89 , 0.73 - 1.07 , p=0.206 ) ; 232 and 309 , respectively , had fatal or non-fatal stroke ( 0.75 , 0.63 - 0.89 , p=0.001 ) ; and myocardial infa rct ion ( non-fatal and fatal ) occurred in 198 and 188 , respectively ( 1.07 , 0.88 - 1.31 , p=0.491 ) . New-onset diabetes was less frequent with losartan . Interpretation Losartan prevents more cardiovascular morbidity and death than atenolol for a similar reduction in blood pressure and is better tolerated . Losartan seems to confer benefits beyond reduction in blood pressure Background —Previous studies have reported that blood pressure response to antihypertensive medications is influenced by genetic variation in the renin-angiotensin-aldosterone system , but no clinical trails have tested whether the ACE insertion/deletion ( I/D ) polymorphism modifies the association between the type of medication and multiple cardiovascular and renal phenotypes . Methods and Results —We used a double-blind , active-controlled r and omized trial of antihypertensive treatment that included hypertensives ≥55 years of age with ≥1 risk factor for cardiovascular disease . ACE I/D genotypes were determined in 37 939 participants r and omized to chlorthalidone , amlodipine , lisinopril , or doxazosin treatments and followed up for 4 to 8 years . Primary outcomes included fatal coronary heart disease ( CHD ) and /or nonfatal myocardial infa rct ion . Secondary outcomes included stroke , all-cause mortality , combined CHD , and combined cardiovascular disease . Fatal and nonfatal CHD occurred in 3096 individuals during follow-up . The hazard rates for fatal and nonfatal CHD and the secondary outcomes were similar across antihypertensive treatments . ACE I/D genotype group was not associated with fatal and nonfatal CHD ( relative risk of DD versus ID and II , 0.99 ; 95 % CI , 0.91 to 1.07 ) or any secondary outcome . The 6-year hazard rate for fatal and nonfatal CHD in the DD genotype group was not statistically different from the ID and II genotype group by type of treatment . No secondary outcome measure was statistically different across antihypertensive treatment and ACE I/D genotype strata . Conclusions —ACE I/D genotype group was not a predictor of CHD , nor did it modify the response to antihypertensive treatment . We conclude that the ACE I/D polymorphism is not a useful marker to predict antihypertensive treatment response BACKGROUND The Valsartan Antihypertensive Long-term Use Evaluation ( VALUE ) trial was design ed to test the hypothesis that for the same blood-pressure control , valsartan would reduce cardiac morbidity and mortality more than amlodipine in hypertensive patients at high cardiovascular risk . METHODS 15?245 patients , aged 50 years or older with treated or untreated hypertension and high risk of cardiac events participated in a r and omised , double-blind , parallel-group comparison of therapy based on valsartan or amlodipine . Duration of treatment was event-driven and the trial lasted until at least 1450 patients had reached a primary endpoint , defined as a composite of cardiac mortality and morbidity . Patients from 31 countries were followed up for a mean of 4.2 years . FINDINGS Blood pressure was reduced by \n Output:\n " }, { "from": "agent", "value": "From the results , we were able to draw conclusions with nearly consistent findings that the conventional genetic variants of the system ( i.e. , the ACE I/D , AGT M235 T , AT1 A1166C , and AT2 variant ) are not associated with antihypertensive effects by RAS blockade , at least by one individual SNP ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The British Regional Heart Study ( BRHS ) reported in 1986 that much of the inverse relation of high-density lipoprotein cholesterol ( HDLC ) and incidence of coronary heart disease was eliminated by covariance adjustment . Using the proportional hazards model and adjusting for age , blood pressure , smoking , body mass index , and low-density lipoprotein cholesterol , we analyzed this relation separately in the Framingham Heart Study ( FHS ) , Lipid Research Clinics Prevalence Mortality Follow-up Study ( LRCF ) and Coronary Primary Prevention Trial ( CPPT ) , and Multiple Risk Factor Intervention Trial ( MRFIT ) . In CPPT and MRFIT ( both r and omized trials in middle-age high-risk men ) , only the control groups were analyzed . A 1-mg/dl ( 0.026 mM ) increment in HDLC was associated with a significant coronary heart disease risk decrement of 2 % in men ( FHS , CPPT , and MRFIT ) and 3 % in women ( FHS ) . In LRCF , where only fatal outcomes were documented , a 1-mg/dl increment in HDLC was associated with significant 3.7 % ( men ) and 4.7 % ( women ) decrements in cardiovascular disease mortality rates . The 95 % confidence intervals for these decrements in coronary heart and cardiovascular disease risk in the four studies overlapped considerably , and all contained the range 1.9 - 2.9 % . HDLC levels were essentially unrelated to non-cardiovascular disease mortality . When differences in analytic methodology were eliminated , a consistent inverse relation of HDLC levels and coronary heart disease event rates was apparent in BRHS as well as in the four American studies BACKGROUND In observational analyses , higher levels of high-density lipoprotein ( HDL ) cholesterol have been associated with a lower risk of coronary heart disease events . However , whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain . Inhibition of cholesteryl ester transfer protein ( CETP ) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes . METHODS We r and omly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib , at a dose of 600 mg daily , or placebo , in addition to the best available evidence -based care . The primary efficacy end point was a composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , unstable angina , or cardiac arrest with resuscitation . RESULTS At the time of r and omization , the mean HDL cholesterol level was 42 mg per deciliter ( 1.1 mmol per liter ) , and the mean low-density lipoprotein ( LDL ) cholesterol level was 76 mg per deciliter ( 2.0 mmol per liter ) . Over the course of the trial , HDL cholesterol levels increased from baseline by 4 to 11 % in the placebo group and by 31 to 40 % in the dalcetrapib group . Dalcetrapib had a minimal effect on LDL cholesterol levels . Patients were followed for a median of 31 months . At a prespecified interim analysis that included 1135 primary end-point events ( 71 % of the projected total number ) , the independent data and safety monitoring board recommended termination of the trial for futility . As compared with placebo , dalcetrapib did not alter the risk of the primary end point ( cumulative event rate , 8.0 % and 8.3 % , respectively ; hazard ratio with dalcetrapib , 1.04 ; 95 % confidence interval , 0.93 to 1.16 ; P=0.52 ) and did not have a significant effect on any component of the primary end point or total mortality . The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo ( P<0.001 for both comparisons ) . CONCLUSIONS In patients who had had a recent acute coronary syndrome , dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events . ( Funded by F. Hoffmann-La Roche ; dal- OUTCOMES Clinical Trials.gov number , NCT00658515 . ) Background — There is no r and omized , double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline -adjusted treatment of acute myocardial infa rct ion . Methods and Results — OMEGA is a r and omized , placebo-controlled , double-blind , multicenter trial testing the effects of omega-3-acid ethyl esters-90 ( 1 g/d for 1 year ) on the rate of sudden cardiac death in survivors of acute myocardial infa rct ion , if given in addition to current guideline -adjusted treatment . Secondary end points were total mortality and nonfatal clinical events . Patients ( n=3851 ; female , 25.6 % ; mean age , 64.0 years ) were r and omized in 104 German centers 3 to 14 days after acute myocardial infa rct ion from October 2003 until June 2007 . Acute coronary angiography was performed in 93.8 % and acute percutaneous coronary intervention in 77.8 % of all patients . During a follow-up of 365 days , the event rates were ( omega and control groups ) as follows : sudden cardiac death , 1.5 % and 1.5 % ( P=0.84 ) ; total mortality , 4.6 % and 3.7 % ( P=0.18 ) ; major adverse cerebrovascular and cardiovascular events , 10.4 % and 8.8 % ( P=0.1 ) ; and revascularization in survivors , 27.6 % and 29.1 % ( P=0.34 ) . Conclusions — Guideline -adjusted treatment of acute myocardial infa rct ion results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up , which could not be shown to be further reduced by the application of omega-3 fatty acids . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00251134 BACKGROUND Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease . We aim ed to test the hypothesis that long-term use of eicosapentaenoic acid ( EPA ) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish . METHODS 18 645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999 . Patients were r and omly assigned to receive either 1800 mg of EPA daily with statin ( EPA group ; n=9326 ) or statin only ( controls ; n=9319 ) with a 5-year follow-up . The primary endpoint was any major coronary event , including sudden cardiac death , fatal and non-fatal myocardial infa rct ion , and other non-fatal events including unstable angina pectoris , angioplasty , stenting , or coronary artery bypass grafting . Analysis was by intention-to-treat . The study was registered at Clinical Trials.gov , number NCT00231738 . FINDINGS At mean follow-up of 4.6 years , we detected the primary endpoint in 262 ( 2.8 % ) patients in the EPA group and 324 ( 3.5 % ) in controls-a 19 % relative reduction in major coronary events ( p=0.011 ) . Post-treatment LDL cholesterol concentrations decreased 25 % , from 4.7 mmol/L in both groups . Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events . Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group . Sudden cardiac death and coronary death did not differ between groups . In patients with a history of coronary artery disease who were given EPA treatment , major coronary events were reduced by 19 % ( secondary prevention subgroup : 158 [ 8.7 % ] in the EPA group vs 197 [ 10.7 % ] in the control group ; p=0.048 ) . In patients with no history of coronary artery disease , EPA treatment reduced major coronary events by 18 % , but this finding was not significant ( 104 [ 1.4 % ] in the EPA group vs 127 [ 1.7 % ] in the control group ; p=0.132 ) . INTERPRETATION EPA is a promising treatment for prevention of major coronary events , and especially non-fatal coronary events , in Japanese hypercholesterolaemic patients Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9 , which may be a potential therapeutic option for reducing low-density lipoprotein cholesterol ( LDL-C ) levels in patients with hypercholesterolemia . In this 24-week , multicenter , double-blind , placebo-controlled , dose-ranging study ( NCT01592240 ) , subjects with LDL-C levels≥80 mg/dl on stable statin therapy were r and omized to Q14 days subcutaneous placebo or bococizumab 50 , 100 , or 150 mg or Q28 days subcutaneous placebo or bococizumab 200 or 300 mg . Doses of bococizumab were reduced if LDL-C levels persistently decreased to ≤25 mg/dl . The primary end point was the absolute change in LDL-C levels from baseline to week 12 after placebo or bococizumab administration . Continuation of bococizumab administration through to week 24 enabled the collection of safety data over an extended period . Of the 354 subjects r and omized , 351 received treatment ( placebo [ n=100 ] or bococizumab [ n=251 ] ) . The most efficacious bococizumab doses were 150 mg Q14 days and 300 mg Q28 days . Compared with placebo , bococizumab 150 mg Q14 days reduced LDL-C at week 12 by 53.4 mg/dl and bococizumab 300 mg Q28 days reduced LDL-C by 44.9 mg/dl ; this was despite dose reductions in 32.5 % and 34.2 % of subjects at week 10 or 8 , respectively . Pharmacokinetic/pharmacodynamic model-based simulation assuming no dose reductions predicted that bococizumab would lower LDL-C levels by 72.2 and 55.4 mg/dl , respectively . Adverse events were similar across placebo and bococizumab groups . Few subjects ( n=7 ; 2 % ) discontinued treatment because of treatment-related adverse events . In conclusion , bococizumab significantly reduced LDL-C across all doses despite dose reductions in many subjects . Model-based simulations predicted greater LDL-C reduction in the absence of bococizumab dose reduction . The Q14 days regimen is being evaluated in phase 3 clinical trials A total of 96 patients with moderate elevations of low-density lipoprotein ( LDL ) cholesterol were r and omly assigned to 4 different double-blind treatment regimens : placebo ; colestipol 5 g and lovastatin 20 mg/day ( C5 + L20 ) ; colestipol 10 g and lovastatin 20 mg/day ( C10 + L20 ) ; and lovastatin 40 mg/day ( L40 ) . During 12 weeks of therapy , C10 + L20 achieved the greatest reduction in total cholesterol ( -32 % ) and LDL cholesterol ( -48 % ) levels from baseline . This combination also exhibited significantly greater reductions in LDL cholesterol levels than the C5 + L20 and L40 groups ( p < 0.01 ) . The differences in total and LDL cholesterol reduction between the C5 + L20 and L40 groups were not significant . Similar changes and differences between treatments were seen in apolipoprotein B levels . Whereas mean total apolipoprotein A-I levels increased with all treatments ( p < 0.05 ) , lipoprotein particles A-I were significantly increased in the C10 + L20 group ( p < 0.01 ) only . Results demonstrate that the combination of low-dose lovastatin ( 20 mg/day ) with low-dose colestipol ( 5 or 10 g/day ) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin ( 40 mg/day ) . In addition , low-dose combinations are > 25 % more cost-effective than high-dose monotherapy In a double-blind clinical trial of clofibrate versus identical quantity of corn oil 497 patients with ischaemic heart disease were observed over a period of five years . The death rate and the rate of non-fatal infa rcts were significantly less among the clofibrate group , and the difference was greatest in respect of sudden deaths and among \n Output:\n " }, { "from": "agent", "value": "FINDINGS Niacin may reduce cardiovascular events as monotherapy ; however , recent trials in combination with statins have failed to show a benefit .\nTrials with omega-3 FAs have failed to demonstrate significant reductions in cardiovascular outcomes .\nFibrates may improve cardiovascular outcomes as monotherapy ; however , trials in combination with statins have failed to show a benefit , except in those with elevated triglycerides ( > 200 mg/dL ) or low HDL-C ( < 40 mg/dL ) .\nThere is a lack of data that evaluates bile acid sequestrant in combination with statin therapy on reducing cardiovascular events .\nIMPLICATION S Nonstatin therapies have a limited role in reducing cardiovascular events in those maintained on guideline -directed statin therapy .\nIn certain clinical situations , such as patients who are unable to tolerate statin therapy or recommended intensities of statin therapy , those with persistent severe elevations in triglycerides , or patients with high cardiovascular risk , some nonstatin therapies may be useful in reducing cardiovascular events ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 Ultrasound is commonly used in association with other forms of treatment in the management of sprains of the lateral ligament of the ankle . Despite its widespread use there is little scientific evidence to support its role in the management of sprained ankles . We have conducted a prospect i ve , r and omized , double-blind trial to compare the results of physiotherapy for sprains of the lateral ligament of the ankle without the use of ultrasound with physiotherapy which included ultrasound . The results in the 154 patients who entered the trial demonstrate that there was no significant difference between the results achieved by the group treated with ultrasound and by those managed without Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration OBJECTIVE The purpose of this study was to determine the efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains . DESIGN A single-blind , comparative , controlled pilot study . SETTING Technikon Natal Chiropractic Day Clinic . PARTICIPANTS Thirty patients with subacute and chronic grade I and grade II ankle inversion sprains . Patients were recruited from the public ; they responded to advertisements placed in newspapers and on notice boards around the campus and local sports clubs . INTERVENTION Each of the 15 patients in the treatment group received the ankle mortise separation adjustment . Each of the 15 patients in the placebo group received 5 minutes of detuned ultrasound treatment . Each participant received a maximum of 8 treatment sessions spread over a period of 4 weeks . MAIN OUTCOME MEASURE Patients were evaluated at the first treatment , at the final treatment , and at a 1-month follow-up consultation . Subjective scores were obtained by means of the short-form McGill Pain Question naire and the Numerical Pain Rating Scale 101 . Objective measurements were obtained from goniometer readings measuring ankle dorsiflexion range of motion and algometer readings measuring pain threshold over the ankle lateral ligaments . A functional evaluation of ankle function was also used . RESULTS Although both groups showed improvement , statistically significant differences in favor of the adjustment group were noted with respect to reduction in pain , increased ankle range of motion , and ankle function . CONCLUSIONS This study appears to indicate that the mortise separation adjustment may be superior to detuned ultrasound therapy in the management of subacute and chronic grade I and grade II inversion ankle sprains OBJECTIVE --To determine the quality of r and omised controlled trials of exercise therapy for back pain . DESIGN --Computer aided search of published papers and blinded assessment of the methods of studies . SUBJECTS--23 r and omised controlled trials , of which 16 studied exercise therapy given by physiotherapists to individual patients with back pain . Other conservative treatments could be included . MAIN OUTCOME MEASURES --Score for quality of methods ( based on four main categories : study population , interventions , measurement of effect , and data presentation and analysis ) and main conclusion of author(s ) with regard to exercise therapy . RESULTS --Only four studies scored more than 50 points ( maximum 100 ) , indicating that most were of poor quality . Six studies found that exercise was better than reference treatments and 10 reported it to be no better or worse than the reference treatment . Those reporting positive results tended to have higher methods scores ( 4/6 positive v 4/10 negative scored greater than or equal to 42 ) . CONCLUSIONS --No conclusion can be drawn about whether exercise therapy is better than other conservative treatments for back pain or whether a specific type of exercise is more effective . Further trials are needed in which greater attention is paid to methods of study R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results \n Output:\n " }, { "from": "agent", "value": "As yet , only few trials are available and no conclusions can be made regarding an optimal and adequate dosage schedule for ultrasound therapy , and whether such a schedule would improve on the reported effectiveness of ultrasound for ankle sprains" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Perioperative anemia leads to increased morbidity and mortality and potentially inhibits rehabilitation after hip fracture surgery . As such , the optimum transfusion threshold after hip fracture surgery is unknown . PATIENTS AND METHODS A total of 120 elderly , cognitively intact hip fracture patients admitted from their own home were r and omly assigned to receive transfusion at a hemoglobin threshold of 10.0 g per dL ( liberal ) versus 8.0 g per dL ( restrictive ) in the entire perioperative period . Patients were treated according to a well-defined multimodal rehabilitation program . Primary outcome was postoperative functional mobility measured with the cumulated ambulation score ( CAS ) . RESULTS Patients in the liberal group received transfusions more frequently than those in the restrictive group ( 44 patients vs. 22 patients ; p < 0.01 ) and received more transfusions during hospitalization ( median , 2 units [ interquartile range , 1 - 2 ] vs. 1 [ 1 - 2 ] ; p < 0.0001 ) . There were no significant differences in postoperative rehabilitation scores ( CAS : median , 9 [ 9 - 15 ] vs. 9 [ 9 - 13.5 ] ; p = 0.46 ) or in length of stay ( median , 18 days vs. 16 days , respectively ; p = 0.46 ) . There were fewer patients in the liberal transfusion group with cardiovascular complications ( 2 % vs. 10 % ; p = 0.05 ) and a lower mortality ( 0 % vs. 8 % ; p = 0.02 ) . CONCLUSION Although a liberal transfusion trigger did not result in increased ambulation scores , restrictive transfusion thresholds should be treated with caution in elderly high-risk hip fracture patients , until their safety has been proved in larger r and omized studies BACKGROUND AND OBJECTIVES Red cell transfusion is commonly used in orthopaedic surgery . Evidence suggests that a restrictive transfusion strategy may be safe for most patients . However , concern has been raised over the risks of anaemia in those with ischaemic cardiac disease . Perioperative silent myocardial ischaemia ( SMI ) has a relatively high incidence in the elderly population undergoing elective surgery . This study used Holter monitoring to compare the effect of a restrictive and a liberal red cell transfusion strategy on the incidence of SMI in patients without signs or symptoms of ischaemic heart disease who were undergoing lower limb arthroplasty . MATERIAL S AND METHODS We performed a multicentre , controlled trial in which 260 patients undergoing elective hip and knee replacement surgery were enrolled and r and omized to transfusion triggers that were either restrictive ( 8 g/dl ) or liberal ( 10 g/dl ) . Participants were monitored with continuous ambulatory electrocardiogram ( ECG ) ( Holter monitoring ) , preoperatively for 12 h and postoperatively for 72 h. The tapes were analysed for new ischaemia by technicians blinded to treatment . The total ischaemia time in minutes was divided by the recording time in hours and an ischaemic load in min/h was calculated . Haemoglobin levels were measured preoperatively , postoperatively in the recovery room , and on days one , three and five after surgery . RESULTS The mean postoperative haemoglobin concentration was 9.87 g/dl in the restrictive group and 11.09 g/dl in the liberal group . In the restrictive group , 34 % were transfused a total of 89 red cell units , and in the liberal group 43 % were given a total of 119 red cell units . A postoperative episode of silent ischaemia was experienced by 21/109 ( 19 % ) patients in the restrictive group and by 26/109 ( 24 % ) patients in the liberal group [ mean difference -4.6 % ; 95 % confidence interval ( CI ) : -15.5 % to 6 % , P = 0.41 ) . There was no significant difference ( P = 0.53 ) between the overall ischaemic load in the restrictive group ( median 0 min/h , range 0 - 4.18 ) and the liberal group ( median 0 min/h , range 0 - 19.48 ) . In those patients who did experience postoperative SMI , the mean ischaemic load was 0.48 min/h in the restrictive group and 1.51 min/h in the liberal group ( ratio 0.32 , 95 % CI : 0.14 - 0.76 , P = 0.011 ) . The median postoperative length of hospital stay in the restrictive group was 7.3 days [ range 5 - 11 ; interquartile range ( IQR ) 6 - 8 ] compared with 7.5 days ( range 5 - 13 ; IQR 7 - 8 ) in the liberal group . The numbers were not large enough to conclude equivalence . CONCLUSIONS In patients without preoperative evidence of myocardial ischaemia undergoing elective hip and knee replacement surgery , a restrictive transfusion strategy seems unlikely to be associated with an increased incidence of SMI . A proportion of these patients experience moderate SMI , regardless of the transfusion trigger . Use of a restrictive transfusion strategy did not increase length of hospital stay , and use of this strategy would lead to a significant reduction in red cell transfusion in orthopaedic surgery . Our data did not indicate any potential for harm in employing such a strategy in patients with no prior evidence of cardiac ischaemia who were undergoing elective orthopaedic surgery Objective To evaluate the immediate effects of red blood cell transfusion on central venous oxygen saturation and lactate levels in septic shock patients with different transfusion triggers . Methods We included patients with a diagnosis of septic shock within the last 48 hours and hemoglobin levels below 9.0g/dL Patients were r and omized for immediate transfusion with hemoglobin concentrations maintained above 9.0g/dL ( Group Hb9 ) or to withhold transfusion unless hemoglobin felt bellow 7.0g/dL ( Group Hb7 ) . Hemoglobin , lactate , central venous oxygen saturation levels were determined before and one hour after each transfusion . Results We included 46 patients and 74 transfusions . Patients in Group Hb7 had a significant reduction in median lactate from 2.44 ( 2.00 - 3.22 ) mMol/L to 2.21 ( 1.80 - 2.79 ) mMol/L , p = 0.005 , which was not observed in Group Hb9 [ 1.90 ( 1.80 - 2.65 ) mMol/L to 2.00 ( 1.70 - 2.41 ) mMol/L , p = 0.23 ] . Central venous oxygen saturation levels increased in Group Hb7 [ 68.0 ( 64.0 - 72.0)% to 72.0 ( 69.0 - 75.0)% , p < 0.0001 ] but not in Group Hb9 [ 72.0 ( 69.0 - 74.0)% to 72.0 ( 71.0 - 73.0)% , p = 0.98 ] . Patients with elevated lactate or central venous oxygen saturation < 70 % at baseline had a significant increase in these variables , regardless of baseline hemoglobin levels . Patients with normal values did not show a decrease in either group . Conclusion Red blood cell transfusion increased central venous oxygen saturation and decreased lactate levels in patients with hypoperfusion regardless of their baseline hemoglobin levels . Transfusion did not appear to impair these variables in patients without hypoperfusion . Clinical Trials.gov OBJECTIVE In elective orthopaedic hip- and knee replacement surgery patients , we studied the effect of implementation of a uniform transfusion policy on RBC usage . STUDY DESIGN AND METHODS A r and omized , controlled study . A new uniform , restrictive transfusion policy was compared with st and ard care , which varied among the three participating hospitals . Only prestorage leucocyte-depleted RBC(s ) were used . Primary end-point was RBC usage , related to length of hospital stay . Secondary end-points were Hb levels , mobilization delay and postoperative complications . RESULTS Six hundred and three patients were evaluated . Adherence to the protocol was over 95 % . Overall mean RBC usage was 0.78 U/patient in the new policy group and 0.86 U/patient in the st and ard care policy group ( mean difference 0.08;95 % CI [ -0.3 ; 0.2 ] ; P = 0.53 ) . In two hospitals , the new transfusion policy result ed in a RBC reduction of 30 % ( 0.58U RBC/patient ) ( P = 0.17 ) and 41 % ( 0.29 U RBC/patient ) ( P = 0.05 ) respectively . In the third hospital , however , RBC usage increased by 39 % ( 0.31 U RBC/patient ) ( P = 0.02 ) with the new policy , due to a more restrictive st and ard care policy in that hospital . Length of hospital stay was not influenced by either policy . CONCLUSIONS Implementation of a uniform transfusion protocol for elective lower joint arthroplasty patients is feasible , but does not always lead to a RBC reduction . Length of hospital stay was not affected Background : Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients , but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer . Methods : In a r and omized , controlled , parallel-group , double-blind ( patients and outcome assessors ) superiority trial in the intensive care unit of a tertiary oncology hospital , the authors evaluated whether a restrictive strategy of erythrocyte transfusion ( transfusion when hemoglobin concentration < 7 g/dl ) was superior to a liberal one ( transfusion when hemoglobin concentration < 9 g/dl ) for reducing mortality and severe clinical complications among patients having major cancer surgery . All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and r and omly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy . The primary outcome was a composite endpoint of mortality and morbidity . Results : A total of 198 patients were included as follows : 101 in the restrictive group and 97 in the liberal group . The primary composite endpoint occurred in 19.6 % ( 95 % CI , 12.9 to 28.6 % ) of patients in the liberal- strategy group and in 35.6 % ( 27.0 to 45.4 % ) of patients in the restrictive- strategy group ( P = 0.012 ) . Compared with the restrictive strategy , the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16 % ( 3.8 to 28.2 % ) and a number needed to treat of 6.2 ( 3.5 to 26.5 ) . Conclusion : A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy Background : Due to the floating of the guideline , there is no evidence -based evaluation index on when to start the blood transfusion for patients with hemoglobin ( Hb ) level between 7 and 10 g/dl . As a result , the trigger point of blood transfusion may be different in the emergency use of the existing transfusion guidelines . The present study was design ed to evaluate whether the scheme can be safely and effectively used for emergency patients , so as to be supported by multicenter and large sample data in the future . Methods : From June 2013 to June 2014 , patients were r and omly divided into the experimental group ( Peri-operative Transfusion Trigger Score of Emergency [ POTTS-E ] group ) and the control group ( control group ) . The between-group differences in the patients ’ demography and baseline information , mortality and blood transfusion-related complications , heart rate , resting arterial pressure , body temperature , and Hb values were compared . The consistency of red blood cell ( RBC ) transfusion st and ards of the two groups of patients with the current blood transfusion guideline , namely the compliance of the guidelines , utilization rate , and per-capita consumption of autologous RBC were analyzed . Results : During the study period , a total of 72 patients were recorded , and 65 of them met the inclusion criteria , which included 33 males and 32 females with a mean age of ( 34.8 ± 14.6 ) years . 50 underwent abdomen surgery , 4 underwent chest surgery , 11 underwent arms and legs surgery . There was no statistical difference between the two groups for demography and baseline information . There was also no statistical differences between the two groups in anesthesia time , intraoperative rehydration , staying time in postanesthetic care unit , emergency hospitalization , postoperative 72 h Acute Physiologic Assessment and Chronic Health Evaluation II scores , blood transfusion-related complications and mortality . Only the POTTS-E group on the 1st postoperative day Hb was lower than group control , P < 0.05 . POTTS-E group was totally ( 100 % ) conformed to the requirements of the transfusion guideline to RBC infusion , which was higher than that of the control group ( 81.25 % ) , P < 0.01 . There were no statistical differences in utilization rates of autologous blood of \n Output:\n " }, { "from": "agent", "value": "The results show that it may not be safe to use a restrictive transfusion threshold of less than 80 g/L in patients with ongoing acute coronary syndrome or chronic cardiovascular disease .\nEffects on mortality and other outcomes are uncertain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Neighborhood-level analyses of influenza vaccination can identify the characteristics of vulnerable neighborhoods , which can inform public health strategy for future p and emics . In this study , the authors analyzed rates of 2009 p and emic A/H1N1 influenza vaccination in Montreal , Quebec , Canada , using individual-level vaccination records from a vaccination registry with census , survey , and administrative data to estimate the population at risk . The neighborhood socioeconomic and demographic determinants of vaccination were identified using Bayesian ecologic logistic regression , with r and om effects to account for spatial autocorrelation . A total of 918,773 ( 49.9 % ) Montreal residents were vaccinated against p and emic A/H1N1 influenza from October 22 , 2009 , through April 8 , 2010 . Coverage was greatest among females , children under age 5 years , and health-care workers . Neighborhood vaccine coverage ranged from 33.6 % to 71.0 % . Neighborhoods with high percentages of immigrants ( per 5 % increase , odds ratio = 0.90 , 95 % credible interval : 0.86 , 0.95 ) and material deprivation ( per 1-unit increase in deprivation score , odds ratio = 0.93 , 95 % credible interval : 0.88 , 0.98 ) had lower vaccine coverage . Half of the Montreal population was vaccinated ; however , considerable heterogeneity in coverage was observed between neighborhoods and subgroups . In future vaccination campaigns , neighborhoods that are material ly deprived or have high percentages of immigrants may benefit from focused interventions BACKGROUND Pregnant women have an increased risk of complications from influenza . Influenza vaccination during pregnancy is considered effective and safe ; however estimates of vaccine coverage are low . This study aim ed to determine influenza vaccination coverage and factors associated with vaccine uptake in pregnant women in two Sydney-based health districts . METHODS A r and om sample of women who delivered a baby in a public hospital in Sydney and South-Western Sydney Local Health Districts between June and September 2012 were surveyed using a computer assisted telephone interviewing service . RESULTS Of the 462 participants ( participation rate 92 % ) , 116 ( 25 % ) reported receiving the influenza vaccine during their pregnancy . In univariate analysis , vaccination coverage varied significantly depending on antenatal care type , hospital of birth , and parity ( p<0.05 ) , but not for age category , highest level of education , country of birth , language spoken at home , or Aboriginal status . Women who received antenatal care through a general practitioner ( GP ) had 2.3 ( 95 % CI 1.4 - 3.6 ) times the odds ( unadjusted ) of receiving the influenza vaccination than those who received their antenatal care through a public hospital . The main reason cited for vaccination was GP recommendation ( 37 % ) , while non- recommendation ( 33 % ) and lack of knowledge ( 26 % ) were cited as main reasons for not receiving the vaccination . 30 % of women recalled receiving a provider recommendation for the vaccination and these women had 33.0 times the odds ( unadjusted ) of receiving the vaccination than women who had not received a recommendation . In a multivariate model a provider recommendation was the only variable that was significantly associated with vaccination ( OR 41.9 ; 95 % CI 20.7 - 84.9 ) . CONCLUSION Rates of influenza vaccination during pregnancy are low . There is a significant relationship between healthcare provider recommendation for the vaccination and vaccine uptake . Increasing provider recommendation rates has the potential to increase coverage rates of influenza vaccination in pregnant women \n Output:\n " }, { "from": "agent", "value": "There was consistently a relationship between SES and influenza immunization , which varied according to how SES was measured ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Regular physical exercise may improve a variety of physiological and psychological factors in depressive persons . However , there is little experimental evidence to support this assumption for adolescent population s. We conducted a r and omized controlled trial to investigate the effect of physical exercise on depressive state , the excretions of stress hormones and physiological fitness variables in adolescent females with depressive symptoms . METHODS Forty-nine female volunteers ( aged 18 - 20 years ; mean 18.8 + /- 0.7 years ) with mild-to-moderate depressive symptoms , as measured by the Centre for Epidemiologic Studies Depression ( CES-D ) scale , were r and omly assigned to either an exercise regimen or usual daily activities for 8 weeks . The subjects were then crossed over to the alternate regimen for an additional 8-week period . The exercise program consisted of five 50-min sessions per week of a group jogging training at a mild intensity . The variables measured were CES-D rating scale , urinary cortisol and epinephrine levels , and cardiorespiratory factors at rest and during exercise endurance test . RESULTS After the sessions of exercise the CES-D total depressive score showed a significant decrease , whereas no effect was observed after the period of usual daily activities ( ANOVA ) . Twenty-four hour excretions of cortisol and epinephrine in urine were reduced due to the exercise regimen . The training group had a significantly reduced resting heart rate and increased peak oxygen uptake and lung capacity . CONCLUSIONS The findings of this study suggest that a group jogging exercise may be effective in improving depressive state , hormonal response to stress and physiological fitness of adolescent females with depressive symptoms PURPOSE The objective of this study is to test the feasibility and impact of a 10-wk after-school exercise program for children with attention deficit hyperactivity disorder and /or disruptive behavior disorders living in an urban poor community . METHODS Children were r and omized to an exercise program ( n = 19 ) or a comparable but sedentary attention control program ( n = 16 ) . Cognitive and behavioral outcomes were collected pre-/posttest . Intent-to-treat mixed models tested group-time and group-time-attendance interactions . Effect sizes were calculated within and between groups . RESULTS Feasibility was evidence d by 86 % retention , 60 % attendance , and average 75 % maximum HR . Group-time results were null on the primary outcome , parent-reported executive function . Among secondary outcomes , between-group effect sizes favored exercise on hyperactive symptoms ( d = 0.47 ) and verbal working memory ( d = 0.26 ) , and controls on visuospatial working memory ( d = -0.21 ) and oppositional defiant symptoms ( d = -0.37 ) . In each group , within-group effect sizes were moderate to large on most outcomes ( d = 0.67 to 1.60 ) . A group-time-attendance interaction emerged on visuospatial working memory ( F[1,33 ] = 7.42 , P < 0.05 ) , such that attendance to the control program was related to greater improvements ( r = 0.72 , P < 0.01 ) , whereas attendance to the exercise program was not ( r = 0.25 , P = 0.34 ) . CONCLUSIONS Although between-group findings on the primary outcome , parent-reported executive function , were null , between-group effect sizes on hyperactivity and visuospatial working memory may reflect adaptations to the specific challenges presented by distinct formats . Both groups demonstrated substantial within-group improvements on clinical ly relevant outcomes . Findings underscore the importance of programmatic features , such as routines , engaging activities , behavior management strategies , and adult attention , and highlight the potential for after-school programs to benefit children with attention deficit hyperactivity disorder and disruptive behavior disorder living in urban poverty where health needs are high and services re sources few This study was conducted to determine the effect of acute aerobic exercise on executive function in children with attention deficit hyperactivity disorder ( ADHD ) . Forty children with ADHD were r and omly assigned into exercise or control groups . Participants in the exercise group performed a moderate intensity aerobic exercise for 30 min , whereas the control group watched a running/exercise-related video . Neuropsychological tasks , the Stroop Test and the Wisconsin Card Sorting Test ( WCST ) , were assessed before and after each treatment . The results indicated that acute exercise facilitated performance in the Stroop Test , particularly in the Stroop Color-Word condition . Additionally , children in the exercise group demonstrated improvement in specific WCST performances in Non-perseverative Errors and Categories Completed , whereas no influences were found in those performances in the control group . Tentative explanations for the exercise effect postulate that exercise allocates attention re sources , influences the dorsolateral prefrontal cortex , and is implicated in exercise-induced dopamine release . These findings are promising and additional investigations to explore the efficacy of exercise on executive function in children with ADHD are encouraged Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors , in children with autism spectrum disorders ( ASD ) , which often contributes to learning difficulties and caregiver burden . The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise , Nei Yang Gong , with that of the conventional Progressive Muscle Relaxation ( PMR ) technique in enhancing the self-control of children with ASD . Forty-six age- and IQ-matched ASD children were r and omly assigned to receive group training in Nei Yang Gong ( experimental group ) or PMR ( control group ) twice per week for four weeks . The participants ’ self-control was measured by three neuropsychological tests and parental rating on st and ardized question naires , and the underlying neural mechanism was assessed by the participants ’ brain EEG activity during an inhibitory-control task before and after intervention . The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group , which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors . In addition , the experimental group showed enhanced EEG activity in the anterior cingulate cortex , a region that mediates self-control , whereas the PMR group did not . The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems . Chinese Clinical Trial Registry ; Registration No. : ChiCTR-TRC-12002561 ; URL : www.chictr.org Attention Deficit Hyperactivity Disorder ( ADHD ) mainly affects the academic performance of children and adolescents . In addition to bringing physical and mental health benefits , physical activity has been used to prevent and improve ADHD comorbidities ; however , its effectiveness has not been quantified . In this study , the effect of physical activity on children 's attention was measured using a computer game . Intense physical activity was promoted by a relay race , which requires a 5-min run without a rest interval . The proposed physical stimulus was performed with 28 volunteers : 14 with ADHD ( GE-EF ) and 14 without ADHD symptoms ( GC-EF ) . After 5 min of rest , these volunteers accessed the computer game to accomplish the tasks in the shortest time possible . The computer game was also accessed by another 28 volunteers : 14 with ADHD ( GE ) and 14 without these symptoms ( GC ) . The response time to solve the tasks that require attention was recorded . The results of the four groups were analyzed using D'Agostino statistical tests of normality , Kruskal-Wallis analyses of variance and post-hoc Dunn tests . The groups of volunteers with ADHD who performed exercise ( GE-EF ) showed improved performance for the tasks that require attention with a difference of 30.52 % compared with the volunteers with ADHD who did not perform the exercise ( GE ) . The ( GE-EF ) group showed similar performance ( 2.5 % difference ) with the volunteers in the ( GC ) group who have no ADHD symptoms and did not exercise . This study shows that intense exercise can improve the attention of children with ADHD and may help their school performance Background Exercise has been shown to be effective in treating depression , but trials testing the effect of exercise for depressed adolescents utilising mental health services are rare . The aim of this study was to determine the effectiveness of a preferred intensity exercise intervention on the depressive symptoms of adolescents with depression . Methods We r and omly assigned 87 adolescents who were receiving treatment for depression to either 12 sessions of aerobic exercise at preferred intensity alongside treatment as usual or treatment as usual only . The primary outcome was depressive symptom change using the Children ’s Depression Inventory 2nd Version ( CDI-2 ) at post intervention . Secondary outcomes were health-related quality of life and physical activity rates . Outcomes were taken at baseline , post intervention and at six month follow up . Results CDI-2 score reduction did not differ significantly between groups at post-intervention ( est . 95 % CI −6.82 , 1.68 , p = 0.23 ) . However , there was a difference in CDI-2 score reduction at six month follow-up in favour of the intervention of −4.81 ( est . 95 % CI −9.49 , −0.12 , p = 0.03 ) . Health-related quality of life and physical activity rates did not differ significantly between groups at post-intervention and follow-up . Conclusions There was no additional effect of preferred intensity exercise alongside treatment as usual on depressive reduction immediately post intervention . However , effects were observed at six months post-intervention , suggesting a delayed response . However , further trials , with larger sample s are required to determine the validity of this finding . Trial registration Clinical Trials.gov NCT01474837 , March 16 The Depressed Adolescents Treated with Exercise ( DATE ) study evaluated a st and ardized aerobic exercise protocol to treat nonmedicated adolescents that met DSM-IV-TR criteria for major depressive disorder . From an initial screen of 90 individuals , 30 adolescents aged 12 - 18 years were r and omized to either vigorous exercise ( EXER ) ( > 12 kg/kcal/week [ KKW ] ) or a control stretching ( STRETCH ) activity ( < 4 KKW ) for 12 weeks . The primary outcome measure was the blinded clinician rating of the Children 's Depression Rating Scale - Revised ( CDRS-R ) to assess depression severity and Actical ( KKW ) accelerometry 24hr/7days a week to assess energy expenditure and adherence . Follow-up evaluations occurred at weeks 26 and 52 . The EXER group averaged 77 % adherence and the STRETCH group 81 % for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements . There was a significant increase in overall weekly KKW expenditures ( p < .001 ) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure . Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks ( p < .016 ) and nine weeks ( p < .001 ) . Both groups continued to improve such that there were no group differences after 12 weeks ( p = .07 ) . By week 12 , the exercise group had a 100 % response rate ( 86 % remission ) , whereas the stretch group response rate was 67 % ( 50 % remission ) ( p = .02 ) . Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers . Anthropometry reflected decreased waist , hip and thigh measurements ( p = .02 ) , more so for females than males ( p = .05 ) , but there were no weight changes for either gender . The EXER group sustained 100 % remission at week 26 and 52 . The STRETCH group had 80 % response and 70 % remission rates at week 26 and by week 52 only one had not fully responded . The study provides support for the use of exercise as a non-medication intervention for adolescents with major depressive disorders when good adherence and energy expenditure ( KKW ) are achieved OBJECTIVE To test the dose-response effects of an exercise program on depressive symptoms and self-worth in children . METHOD Overweight , sedentary children ( N = 207 , 7 - 11 years , 58 % male , 59 % Black ) were r and omly assigned to low or high dose ( 20 or 40 min/day ) aerobic exercise programs ( 13 + /- 1.6 weeks ) , or control group . Children completed the Reynolds Child Depression Scale and Self-Perception Profile for Children at baseline and posttest . RESULTS A dose-response benefit of exercise was detected for depressive symptoms . A race x group interaction showed only White children 's global self-worth ( GSW ) improved . There was some evidence that increased self-worth mediated the effect on depressive symptoms . CONCLUSIONS This study shows dose-response benefits of exercise on depressive symptoms and self-worth in children . However , Blacks did not show increased GSW in response to the intervention . Results provide some support for mediation of the effect of exercise on depressive symptoms via self-worth Aerobic moderate-intensity continuous exercise ( MCE ) can improve executive function ( EF ) acutely , potentially through the activation of both physiological and psychological factors . Recently , high-intensity interval exercise ( HIIE ) has been reported to be more beneficial for physical adaptation than MCE . Factors for EF improvement can potentially be more enhanced by HIIE than by MCE ; but the effects of HIIE on EF remain unknown . Therefore , we aim ed to examine to what extent HIIE impacts post-exercise EF immediately after exercise and during post-exercise recovery , compared with traditional MCE . Twelve healthy male subjects performed cycle ergometer exercise based on either HIIE or MCE protocol s in a r and omized and counterbalanced order . The HIIE protocol consisted \n Output:\n " }, { "from": "agent", "value": "Conclusion : Although additional research is warranted to further underst and the mechanisms by which PA affects behavioral and cognitive outcome measures in children with SEBDs , PA offers a safe and alternative form of treatment for this population" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: An elevated level of C-reactive protein is a strong predictor of cardiovascular events in elderly persons . Whether C-reactive protein has direct adverse vascular effects or is a marker of aspecific systemic inflammation remains to be determined . The aim of this study was to investigate the relation between C-reactive protein and the occurrence of fatal strokes in elderly persons . In the Leiden 85-Plus Study , a population -based prospect i ve follow-up study , we studied the levels of C-reactive protein in 80 participants who died from stroke within the first 5 years of follow-up . Levels of C-reactive protein were determined in serum sample s at baseline . Levels of C-reactive protein were also determined in 82 control subjects who survived for the first 5 years of follow-up and in 83 participants who died from noncardiovascular causes . Mortality risks were estimated with logistic regression and adjusted for differences in age , sex , smoking , medication , total cholesterol , history of diabetes or hypertension , and previous cardiovascular events . Levels of C-reactive protein at baseline were 2-fold higher in subjects who died from stroke than in control subjects ( median 5.7 versus 2.7 mg/L , P<0.005 ) . The levels of C-reactive protein in subjects who died from stroke or from noncardiovascular causes were similar ( median 5.7 versus 4.9 mg/L , P=0.7 ) . The risk of death from stroke as well as from noncardiovascular causes increased linearly up to 10-fold in subjects with the highest levels of C-reactive protein at baseline ( P<0.001 ) . The levels of C-reactive protein were lower when more time had elapsed between blood sampling and time of death during follow-up ( P=0.01 ) . C-reactive protein is a strong but nonspecific risk factor of fatal stroke in old persons . The data do not support the idea that C-reactive protein has direct vascular effects that underlie fatal cerebrovascular disease Little is known about the prospect i ve associations of fibrinogen , factor VII , or factor VIII with cardiovascular disease ( CVD ) and mortality in the elderly . At baseline in the Cardiovascular Health Study ( 5888 white and African American men and women ; aged > /=65 years ) , we measured fibrinogen , factor VIII , and factor VII . We used sex-stratified stepwise Cox survival analysis to determine relative risks ( RRs ) for CVD events and all-cause mortality ( up to 5 years of follow-up ) , both unadjusted and adjusted for CVD risk factors and sub clinical CVD . After adjustment , comparing the fifth quintile to the first , fibrinogen was significantly associated in men with coronary heart disease events ( RR=2.1 ) and stroke or transient ischemic attack ( RR=1.3 ) , and also with mortality within 2.5 years of follow-up ( RR=5.8 ) and later ( RR=1.7 ) . Factor VIII was significantly associated in men with coronary heart disease events ( RR=1.5 ) and mortality ( RR=1.8 ) , and in women with stroke/transient ischemic attack ( RR=1.4 ) . For both factors , values were higher in those who died , whether causes were CVD-related or non-CVD-related , but highest in CVD death . Factor VII exhibited associations with incident angina ( RR=1.44 ) in men and with death in women ( RR , middle quintile compared with first=0.66 ) . However , in general , factor VII was not consistently associated with CVD events in this population . We conclude that , if confirmed in other studies , the measurement of fibrinogen and /or factor VIII may help identify older individuals at higher risk for CVD events and mortality BACKGROUND Among apparently healthy men , elevated levels of C-reactive protein ( CRP ) , a marker for systemic inflammation , predict risk of myocardial infa rct ion and thromboembolic stroke . Whether increased levels of CRP are also associated with the development of symptomatic peripheral arterial disease ( PAD ) is unknown . METHODS AND RESULTS Using a prospect i ve , nested , case-control design , we measured baseline levels of CRP in 144 apparently healthy men participating in the Physicians ' Health Study who subsequently developed symptomatic PAD ( intermittent claudication or need for revascularization ) and in an equal number of control subjects matched on the basis of age and smoking habit who remained free of vascular disease during a follow-up period of 60 months . Median CRP levels at baseline were significantly higher among those who subsequently developed PAD ( 1.34 versus 0.99 mg/L ; P=.04 ) . Furthermore , the risks of developing PAD increased significantly with each increasing quartile of baseline CRP concentration such that relative risks of PAD from lowest ( referent ) to highest quartile of CRP were 1.0 , 1.3 , 2.0 , and 2.1 ( Ptrend=.02 ) . Compared with those with no clinical evidence of disease , the subgroup of case patients who required revascularization had the highest baseline CRP levels ( median= 1.75 mg/L ; P= .04 ) ; relative risks from lowest to highest quartile of CRP for this end point were 1.0 , 1.8 , 3.8 , and 4.1 ( Ptrend=.02 ) . Risk estimates were similar after additional control for body mass index , hypercholesterolemia , hypertension , diabetes , and a family history of premature atherosclerosis . CONCLUSIONS These prospect i ve data indicate that among apparently healthy men , baseline levels of CRP predict future risk of developing symptomatic PAD and thus provide further support for the hypothesis that chronic inflammation is important in the pathogenesis of atherothrombosis BACKGROUND AND PURPOSE Several cross-sectional and prospect i ve studies have indicated that high titers of antibodies to Chlamydia pneumoniae and cytomegalovirus ( CMV ) are associated with coronary heart disease . The aim of the present study was to examine whether elevated titers of antibodies to these pathogens are predictive of not only coronary but also cerebrovascular disease . METHODS Serum titers of antibodies to C pneumoniae ( IgM , IgG , IgA , IgG immune complex ) and CMV ( IgG ) were determined at baseline ( n=130 ) and after 3.5 years ( n=111 ) in a total sample of 152 men . All individuals had treated hypertension and at least 1 additional risk factor for cardiovascular disease ( hypercholesterolemia , smoking , or diabetes mellitus ) and constituted 93 % of a r and omly selected subgroup ( n=164 ) of patients participating in a multiple risk factor intervention study . RESULTS Elevations of any or both of the IgA or IgG titers to C pneumoniae at entry or after 3.5 years were found in 84 cases ( 55 % ) . Of those with high titers at entry , 97 % remained high at the 3.5 year reexamination . After 6.5 years of follow-up , high titers to C pneumoniae at entry were associated with an increased risk for future stroke ( relative risk [ RR ] , 8.58 ; P=0.043 ; 95 % CI , 1.07 to 68.82 ) and for any cardiovascular event ( RR , 2.69 ; P=0.042 ; 95 % CI , 1.04 to 6.97 ) . A high serum titer of antibodies to CMV was found in 125 cases ( 85 % ) , and this was not associated with an increased risk of future cardiovascular events . CONCLUSIONS Seropositivity for C pneumoniae , but not for CMV , was associated with an increased risk for future cardiovascular disease and , in particular , stroke OBJECTIVE : To determine whether Helicobacter pylori , a chronic bacterial infection often acquired in childhood , is associated with increased risk of coronary heart disease and stroke later in life . DESIGN : Nested case-control study . SETTING : Prospect i ve study of cardiovascular disease in men aged 40 - 59 years at entry ( 1978 - 1980 ) in 24 British towns . SUBJECTS : 135 cases of myocardial infa rct ion and 137 cases of stroke occurring before December 1991 ; 136 controls were identified , frequency matched to cases by town and age group . METHODS : Serum sample s stored at entry were analysed by an enzyme linked immunosorbent assay for the presence of H pylori specific IgG antibodies . RESULTS : 95 of the myocardial infa rct ion cases ( 70 % ) and 93 ( 68 % ) of the stroke cases were seropositive for H pylori compared with 78 ( 57 % ) of the controls ( odds ratio for myocardial infa rct ion 1.77 , 95 % confidence interval ( CI ) 1.06 to 2.95 , P = 0.03 ; odds ratio for stroke 1.57 , 95 % CI 0.95 to 2.60 , P = 0.07 ) . Helicobacter pylori infection was associated with manual social class , residence in Northern Engl and or Scotl and , cigarette smoking , higher systolic pressure and blood glucose , and a lower height-st and ardised forced expiratory volume in one second . Adjustment for these factors attenuated the relation between H pylori and myocardial infa rct ion ( odds ratio = 1.31 , 95 % CI 0.70 to 2.43 , P = 0.40 ) and effectively abolished the relation with stroke ( odds ratio = 0.96 , 0.46 to 2.02 , P = 0.92 ) . The relation between helicobacter infection and fatal myocardial infa rct ion was slightly stronger ( odds ratio 2.41 , 95 % CI 1.13 to 5.12 ) but was also markedly attenuated after adjustment ( 1.56 , 95 % CI 0.68 to 3.61 ) . CONCLUSION : In this prospect i ve study the association between Helicobacter pylori infection and increased risk of myocardial infa rct ion and stroke was substantially confounded by the relation between this infection , adult social class , and major cardiovascular risk factors BACKGROUND Sinking prebeta lipoprotein is a putative marker for elevated levels of lipoprotein ( a ) . Although prospect i ve data suggest that increased plasma lipoprotein ( a ) is an independent risk factor for coronary heart disease in men , no prospect i ve studies are available in women . METHODS AND RESULTS From 1968 through 1975 , sinking prebeta lipoprotein was determined by paper electrophoresis in 3103 women Framingham Heart Study participants who were free of prevalent cardiovascular disease . A sinking prebeta lipoprotein b and was detectable in 434 of the women ( 14 % ) studied . The median follow-up interval was approximately 12 years . Incident cardiovascular disease was associated with b and presence using a proportional hazards model that included age , smoking , body mass index , systolic blood pressure , glucose intolerance , low- and high-density lipoprotein cholesterol , and ECG left ventricular hypertrophy . Multivariable adjusted relative risk estimates ( with 95 % confidence intervals ) for outcomes in the b and present versus absent groups were as follows : myocardial infa rct ion ( 82 events ) , 2.37 ( 1.48 to 3.81 ) ; intermittent claudication ( 62 events ) , 1.94 ( 1.07 to 3.50 ) ; cerebrovascular disease ( 83 events ) , 1.88 ( 1.12 to 3.15 ) ; total coronary heart disease ( 174 events ) , 1.61 ( 1.13 to 2.29 ) ; and total cardiovascular disease ( 305 events ) , 1.44 ( 1.09 to 1.91 ) . A subset analysis indicated that b and presence was 50.9 % sensitive and 95.4 % specific for detecting plasma lipoprotein ( a ) levels of > 30 mg/dL , the threshold value linked to increased cardiovascular disease risk in men . CONCLUSIONS Sinking prebeta lipoprotein was a valid surrogate for elevated lipoprotein ( a ) levels in Framingham Heart Study women . B and presence and , equivalently , elevated plasma lipoprotein ( a ) , was a strong , independent predictor of myocardial infa rct ion , intermittent claudication , and cerebrovascular disease . Confirmation of these findings in other longitudinal studies of women is needed Background : To decide whether a person with certain characteristics should be given any kind of intervention to prevent a cardiovascular event , it would be helpful to classify subjects in low , medium and high risk categories . The study evaluated which well known cerebrovascular and cardiovascular correlates , in particular fibrinogen level and ECG characteristics , are able to predict the occurrence of stroke in men of the general population using data from three European cohorts participating in EUROSTROKE . Methods : EUROSTROKE is a collaborative project among ongoing European population based cohort studies and design ed as a prospect i ve nested case-control study . For each stroke case two controls were sample d. Strokes were classified according to MONICA criteria or review ed by a panel of four neurologists . Complete data were available of 698 men ( 219 stroke events ) from cohorts in Cardiff ( 84 cases \n Output:\n " }, { "from": "agent", "value": "Conclusion : Data on novel risk factors for stroke are lacking compared with the equivalent data for acute coronary events , and there are very few data on specific subtypes of ischaemic stroke" } ]