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3OBJECTIVE

The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .

2METHODS

This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .

2METHODS

The investigator was the Food and Drug Administration ( FDA ) sponsor .

2METHODS

The prime site subcontracted , indemnified , and trained consortia members .

2METHODS

Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .

2METHODS

The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .

2METHODS

The planned sample size was n = 200 .

4RESULTS

Eight sites enrolled 87 patients over 5 years .

4RESULTS

The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .

4RESULTS

Primary barrier to enrolment was the cost of screening .

4RESULTS

Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .

1CONCLUSIONS

An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .

1CONCLUSIONS

Quality of life measurements might represent a more important patient-centred end-point .

3OBJECTIVE

To compare in vivo bitewing film quality using the holder versus the paper loop technique .

2METHODS

Four bitewing films were taken from the right and left premolar and molar regions of 45 dental students using both the bitewing holder and paper loop techniques .

2METHODS

A total of 360 films were taken and assessed by an experienced practitioner not apprised of the bitewing technique used .

2METHODS

Of interest were : ( 1 ) the number of overlaps and the percentage of teeth showing the alveolar crest ; ( 2 ) proper film positioning ; and ( 3 ) the percentage of cone cutting .

2METHODS

A Poisson regression using generalized estimating equations ( GEEs ) was used to estimate the difference in overlap between the two techniques .

2METHODS

For proper positioning and cone cutting , logistic regressions using GEEs were used .

4RESULTS

The average number of horizontal overlaps for the loop and holder techniques at the right premolar , right molar , left premolar , and left molar were 1.64 , 2.11 , 2.16 , 2.78 , and 1.64 , 2.00 , 2.00 , 2.18 , respectively .

4RESULTS

The loop technique was 1.11 times more likely to cause overlapping than the holder technique .

4RESULTS

The highest percentage of teeth showing the alveolar crest by the loop technique was 97.8 % in the mandibular second premolar and first molar .

4RESULTS

With respect to film positioning , the loop technique was 1.12 times more likely to cause improper positioning than the holder technique .

4RESULTS

Both techniques demonstrated minimal cone cutting ( 1 in the loop versus 0 in the holder ) .

1CONCLUSIONS

The quality of bitewing films taken by the loop and holder techniques was not significantly different .

3OBJECTIVE

To evaluate clinical efficacy and toxicity of low-dose oral natural human interferon-alpha ( nHuIFN alpha ) on CD4 + lymphocyte counts and clinical symptoms in patients with HIV-1 infection .

2METHODS

Double-blind , randomized , placebo-controlled trial with crossover .

2METHODS

Private practice specializing in the treatment of patients with AIDS .

2METHODS

Only patients with HIV-1 infection and CD4 + lymphocyte counts between 200 and 500 x 10 ( 6 ) / l were included for study .

2METHODS

Thirty out of thirty-one patients at study entry completed treatment with placebo , and 29 completed nHuIFN alpha treatment .

2METHODS

Mean patient age was 36 years ( range , 25-58 years ) .

2METHODS

The 30 patients included 26 men , of whom 22 were homosexual , and four women ; five were drug users and none were currently on zidovudine therapy , although three had been previously .

2METHODS

Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks .

2METHODS

Every 2 weeks , a detailed history , physical examination , and laboratory tests , including CD4 + and CD8 + lymphocyte counts , were conducted .

4RESULTS

There was only a slight , transient increase in mean CD4 + lymphocyte counts after 4 weeks of treatment with nHuIFN alpha , compared with a slight decline when placebo was administered .

4RESULTS

This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks .

4RESULTS

There were no significant changes in weight and clinical symptoms .

4RESULTS

All patients remained HIV-1-antibody-positive .

4RESULTS

Treatment-related adverse reactions were not observed .

1CONCLUSIONS

Our double-blind , randomized , placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha .

1CONCLUSIONS

Although non-toxic , our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials .

0BACKGROUND

Blue-light light-emitting diode ( LED ) therapy has become widely used for the treatment of inflammatory acne .

0BACKGROUND

In this study we evaluated the efficacy of a home use blue-light LED application in improving lesions and shortening their time to clearance .

2METHODS

This was an IRB approved randomized self-control study .

2METHODS

For each patient ( n = 30 ) , 2 similar lesions , one of each side of the face were chosen for treatment with either a blue-light LED hand-held or sham device .

2METHODS

Treatments ( n = 4 ) were conducted twice daily in the clinic and lesions were followed-up till resolution .

2METHODS

Reduction in blemishes size and erythema and the overall improvement were evaluated by both the physician and the patients .

2METHODS

Time to lesion resolution was recorded .

4RESULTS

There was a significant difference in the response of lesions to the blue-light LED application as opposed to the placebo in terms of reduction in lesion size and lesion erythema as well as the improvement in the overall skin condition ( p < 0.025 ) .

4RESULTS

Signs of improvement were observed as early as post 2 treatments .

4RESULTS

Time to resolution was significantly shorter for the blue-light LED therapy .

1CONCLUSIONS

The results support the effectiveness of using blue-light LED therapy on a daily basis for better improvement and faster resolution of inflammatory acne lesions .

0BACKGROUND

Few treatments are available for isolated pulmonary hypertension ( PHT ) , which has a high morbidity and mortality .

0BACKGROUND

This trial was designed to assess the hemodynamic effects of bosentan , an endothelin receptor antagonist , in patients with PHT , in which local overproduction of endothelin-1 ( ET-1 ) is thought to play a pathogenic role .

4RESULTS

An open-label , dose-ranging study was performed in 7 female patients with primary PHT ( n = 5 ) or isolated PHT associated with limited scleroderma ( n = 2 ) .

4RESULTS

Infusions of 50 , 150 , and 300 mg were administered at 2-hour intervals , and the hemodynamic responses were measured .

4RESULTS

Bosentan caused a dose-dependent fall in total pulmonary resistance ( -20.0 + / -11.0 % , P = 0.01 ) and mean pulmonary artery pressure ( -10.6 + / -11.0 % , P > 0.05 ) .

4RESULTS

However , there was also a fall in the systemic vascular resistance ( -26.2 + / -12.8 % , P < 0.005 ) and mean arterial pressure ( -19.8 + / -14.4 % , P < 0.001 ) .

4RESULTS

There was a slight increase in cardiac index ( 15 + / -12 % , P > 0.05 ) and a dose-dependent rise in ET-1 but no significant change in other hemodynamic variables , gas exchange , or other vasoactive mediators .

1CONCLUSIONS

Intravenous bosentan is a potent but nonselective pulmonary vasodilator at the doses tested , even in patients resistant to inhaled nitric oxide .

1CONCLUSIONS

Transient increases in plasma ET-1 were observed , consistent with a blockade of endothelial ET ( B ) receptors .

1CONCLUSIONS

Systemic hypotension and other significant events during the study indicate that its intravenous use in patients with severe PHT may be limited .

1CONCLUSIONS

Implications for future trial design and studies of chronic oral treatment are discussed .

3OBJECTIVE

To compare the prophylactic administration of ondansetron plus droperidol , droperidol plus metoclopramide , and perphenazine to determine effects on postoperative nausea , vomiting , and sedation after laparoscopic cholecystectomy .

2METHODS

Prospective , randomized , double-blind study .

2METHODS

University medical center .

2METHODS

212 ASA physical status I and II adults presenting for laparoscopic cholecystectomy .

2METHODS

Patients were randomly assigned to receive one of three prophylactic antiemetic drug combinations : ondansetron 4 mg plus droperidol 0.625 mg ( Group OD ) , droperidol 0.625 mg plus metoclopramide 10 mg ( Group DM ) , or perphenazine 5 mg ( Group P ) .

2METHODS

Study drugs were administered intravenously after induction of general anesthesia .

4RESULTS

The groups were similar with respect to gender , age , weight , duration of surgery , numbers of patients receiving intraoperative atropine or ephedrine , number admitted overnight , and time to discharge home .

4RESULTS

Patients in Group P used lower total doses of opioids than did patients in Group OD .

4RESULTS

There were no significant differences in postoperative nausea , pain , or sedation scores , in numbers of patients requiring antiemetics ( Group OD , 13 of 66 ; Group DM , 15 of 66 ; Group P , 14 of 68 ) , or in numbers of patients vomiting , either in hospital or during the first postoperative day .

1CONCLUSIONS

These three drug regimens are equivalent for antiemetic prophylaxis before laparoscopic cholecystectomy .

0BACKGROUND

In prior studies , pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome and healthy adults , suggesting reduction of afferent function .

3OBJECTIVE

To assess effects of pregabalin on colonic compliance , sensory and motor functions in patients with constipation-predominant irritable bowel syndrome .

2METHODS

In a pilot , double-blind , placebo-controlled , parallel-group study , we tested oral pregabalin , 200mg , in 18 patients with constipation-predominant irritable bowel syndrome .

2METHODS

With a barostatically controlled polyethylene balloon in the left colon , we assessed sensation thresholds and colonic compliance using ascending method of limits , sensation ratings over 4 levels of distension , fasting and postprandial colonic tone and phasic motility .

2METHODS

Analysis of covariance ( adjusted for the corresponding pre-drug response ) was used to compare placebo and pregabalin .

2METHODS

After 45 % participants completed studies , we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial .

4RESULTS

Pregabalin did not significantly affect colonic compliance , sensation thresholds , sensation ratings , fasting or postprandial tone or motility index .

4RESULTS

The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size .

1CONCLUSIONS

Pregabalin , 200mg , might not reduce distension-related colonic pain in constipation-predominant irritable bowel syndrome patients .

0BACKGROUND

Topical corticosteroids , commonly used for psoriasis , show diminished response on continuous use .

3OBJECTIVE

We tested efficacy of topical corticosteroid and calcipotriene used on alternate weeks versus daily corticosteroid in patients with psoriasis .

2METHODS

In a randomized , observer-blind design , the experimental group of 25 patients with stable plaque psoriasis received augmented betamethasone dipropionate 0.05 % cream once daily in the first and third weeks and calcipotriene 0.005 % ointment twice daily in the second and fourth weeks .

2METHODS

The control group of 27 patients received augmented betamethasone once daily for 4 weeks .

4RESULTS

The experimental regimen was more effective than the control regimen as evidenced by ( 1 ) more patients with at least a 90 % reduction in Psoriasis Area and Severity Index ( PASI ) score ( difference 49.5 % , 95 % confidence interval [ CI ] , 26.1 % -72.9 % , P < .

4RESULTS

001 ) , ( 2 ) lower PASI after 2 weeks ( P < or = .04 ) , and ( 3 ) greater percentage reduction in PASI after 2 and 4 weeks ( difference 23.1 % [ CI , 11.1 % -35.1 % ] and 46.4 % [ 28.9 % -63.8 % ] , respectively ; P < .001 ) .

4RESULTS

The study had power of 93.7 % .

4RESULTS

No patient had skin irritation .

1CONCLUSIONS

Use of augmented betamethasone and calcipotriene on alternate weeks is more effective than daily corticosteroid and represents a novel strategy for treating psoriasis .

0BACKGROUND

Ghrelin stimulates GH secretion and regulates energy and glucose metabolism .

0BACKGROUND

The two circulating isoforms , acyl ( AG ) and des-acyl ( DAG ) ghrelin , have distinct metabolic effects and are under active investigation for their therapeutic potentials .

0BACKGROUND

However , there is only limited data on the pharmacokinetics of AG and DAG .

3OBJECTIVE

To evaluate key pharmacokinetic parameters of AG , DAG , and total ghrelin in healthy men and women .

2METHODS

In study 1 , AG ( 1 , 3 , and 5 g/kg per h ) was infused over 65 min in 12 healthy ( 8 F/4 M ) subjects in randomized order .

2METHODS

In study 2 , AG ( 1 g/kg per h ) , DAG ( 4 g/kg per h ) , or both were infused over 210 min in ten healthy individuals ( 5 F/5 M ) .

2METHODS

Plasma AG and DAG were measured using specific two-site ELISAs ( study 1 and 2 ) , and total ghrelin with a commercial RIA ( study 1 ) .

2METHODS

Pharmacokinetic parameters were estimated by non-compartmental analysis .

4RESULTS

After the 1 , 3 , and 5 g/kg per h doses of AG , there was a dose-dependent increase in the maximum concentration ( C ( max ) ) and area under the curve ( AUC ( 0-last ) ) of AG and total ghrelin .