Randomized, double-blind comparison of 4 mg/kg versus 2 mg/kg intravenous cyclosporine in severe ulcerative colitis1 1Gert Van Assche, Severine Vermeire, Geert D’Haens, and Paul Rutgeerts have been instrumental in the design of the study, trial management, data analysis, and writing the paper. Maja Noman had a major contribution in the clinical ambulatory follow-up of the patients in the trial. Martin Hiele followed cyclosporine levels and adjusted drug doses of patients in the trial and provided statistical advice. Katrien Asnong was the study coordinator and had a major share in data analysis. Joris Arts analyzed safety data and followed patients clinically during the trial. Andre D’Hoore and Freddy Penninckx performed the surgical interventions in patients failing the trial and substantially contributed in evaluating patients for colectomy.

2003 ◽  
Vol 125 (4) ◽  
pp. 1025-1031 ◽  
Author(s):  
Gert Van Assche ◽  
Geert D’haens ◽  
Maja Noman ◽  
Séverine Vermeire ◽  
Martin Hiele ◽  
...  
Keyword(s):  
Data Analysis ◽  
Safety Data ◽  
Study Trial ◽  
Trial Management ◽  
Double Blind ◽  
Surgical Interventions ◽  
Drug Doses ◽  
Blind Comparison

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

A Double-Blind Comparison of Prazepam with Diazepam, Chlorazepate Dipotassium and Placebo in Anxious Out-Patients

1979 ◽  
Vol 7 (2) ◽  
pp. 147-151 ◽  
Author(s):  
Louis F Fabre ◽  
David M McLendon ◽  
Arthur Mallette
Keyword(s):  
Data Analysis ◽  
Side Effects ◽  
Rating Scale ◽  
Double Blind ◽  
Drug Study ◽  
Patient Reported ◽  
Symptom Check List ◽  
Blind Comparison ◽  
Lost To Follow Up ◽  
Age Range

This study compared prazepam with diazepam, chlorazepate dipotassium, and placebo in the treatment of anxious out-patients. Patients were screened for participation in the study to be sure they met the criteria for inclusion. Patients were excluded if they had complicating physical or mental problems. All patients signed an informed consent. Seventy-three patients entered the study, thirteen did not complete at least two weeks of treatment and were not used in the data analysis. Of these thirteen, ten did not return and were lost to follow-up, two entered the hospital for reasons unrelated to the drug study, and one patient on diazepam was terminated because of increased anxiety. Sixty patients were used in the data analysis, thirty-six males and twenty-four females with an age range of 21–61 years. Side-effects were minimal. Drowsiness was reported by two people in the placebo group, one taking chlorazepate dipotassium, three on prazepam and one on diazepam. One diazepam patient reported nausea and vomiting. Scores on the Zung Self-Rating Scale for Anxiety showed all three drug groups to be superior to placebo. The Hopkins Symptom Check-list found prazepam and diazepam to be superior to placebo and chlorazepate. No differences among the groups were found in the Hamilton Anxiety Scale. Prazepam may offer advantages over the other available benzodiazepines since it may be more readily absorbed than chlorazepate and has less side-effects than diazepam.

A Double-Blind Comparison of 0.25% and 0.05% Desoxymethasone, 0.1% Betamethasone Valerate and 1% Hydrocortisone Creams in the Treatment of Eczema

1987 ◽  
Vol 15 (3) ◽  
pp. 160-166 ◽  
Author(s):  
R. E. Ashton ◽  
M. Catterall ◽  
N. Morley ◽  
G. Fairris ◽  
D. N. Joseph
Keyword(s):  
Adverse Effects ◽  
Physical Properties ◽  
Effective Treatment ◽  
The Other ◽  
Betamethasone Valerate ◽  
Clinical Parameters ◽  
Double Blind ◽  
Parallel Group ◽  
Blind Comparison

The efficacy and acceptability of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydrocortisone creams were compared in patients with eczema. A double-blind parallel group multi-centre design was employed in which 96 patients were recruited by four centres. Patients used one cream for a 3-week period and follow-up assessment visits were made at weekly intervals. Efficacy variables were: erythema/redness, scaling, itching and extent of area affected. These variables were assessed by both the investigator and the patient. The 0.25% desoxymethasone was the most effective treatment, producing the greatest degree of improvement in all clinical parameters, hydrocortisone was the least effective and 0.05% desoxymethasone was of intermediate effectiveness. The 0.1% betamethasone produced similar results to 0.25% desoxymethasone for half the assessments; for the other half the results were similar to 0.05% desoxymethasone. No adverse effects were reported during the study. The results are discussed in terms of physical properties of the vehicles and corticosteroid potency.

Updated safety results from EXIST-2: Everolimus therapy for angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) or sporadic lymphangioleiomyomatosis (sLAM).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4632-4632
Author(s):  
John Bissler ◽  
Christopher Kingswood ◽  
B. A. Zonnenberg ◽  
Michael Frost ◽  
Elena Belousova ◽  
...  
Keyword(s):  
Data Analysis ◽  
Disease Progression ◽  
Response Rate ◽  
Safety Data ◽  
Study Drug ◽  
Double Blind Study ◽  
Double Blind ◽  
Initial Analysis ◽  
Response Status ◽  
To Receive

4632 Background: EXIST-2 (NCT00790400) is a randomized, double-blind, placebo-controlled, phase 3 trial assessing the efficacy and safety of everolimus, an oral mTOR inhibitor, for treating AML in patients with TSC or sLAM. We have previously reported that everolimus resulted in a significantly higher AML response rate vs placebo (41.8% vs 0%; 95% CI: 23.5–58.4; p<0.0001) with a consistent safety profile (Bissler et al. J Am Soc Nephrol. 22, 2011, Abstract LB-PO3159). Here we present a 90-day safety update. Methods: 118 eligible patients were randomized 2:1 to receive everolimus 10 mg daily (n=79) or placebo (n=39). The primary efficacy endpoint was AML response rate (proportion of patients with best overall AML response status of “response”). Original cut-off date for data analysis was 30 Jun 2011. An updated analysis of the safety data for the safety set (all patients receiving ≥1 dose of double-blind study drug with a valid post-baseline assessment) to 14 Oct 2011 are presented here. Results: As of 14 Oct 2011, median treatment duration was 48.1 and 45.0 weeks for everolimus and placebo arms, respectively. Discontinuations in the double-blind period were the same in the everolimus arm as the initial analysis, but had increased by 4 patients in the placebo arm since initial analysis (3 due to disease progression, 1 withdrew consent). The majority of adverse events (AEs) continued to be grade 1 or 2; the incidence of serious AEs was slightly higher than initially reported, particularly in the placebo arm (everolimus 20.3%, placebo 23.1%). AE incidence leading to discontinuation was the same as initially reported (everolimus 3.8%, placebo 10.3%). In the updated data, 3 additional everolimus patients required dose interruption or reduction due to AEs; dose reduction/interruption remained more common in the everolimus arm (51.9% vs. 20.5%). Conclusions: Overall, the 90-day updated safety data analysis from the EXIST-2 trial has not revealed any additional safety concerns. No other patients receiving everolimus withdrew for any reason, whereas 3 more patients receiving placebo withdrew due to disease progression.

Everolimus for postmenopausal women with advanced breast cancer: Updated results of the BOLERO-2 phase III trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 559-559 ◽  
Author(s):  
Martine J. Piccart-Gebhart ◽  
Shinzaburo Noguchi ◽  
Kathleen I. Pritchard ◽  
Howard A. Burris ◽  
Hope S. Rugo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Aromatase Inhibitor ◽  
Postmenopausal Women ◽  
Survival Data ◽  
Treatment Options ◽  
Safety Data ◽  
Phase Iii ◽  
Double Blind ◽  
Once Daily

559 Background: Current treatment options for postmenopausal patients with estrogen-receptor–positive (ER+) breast cancer (BC) who relapse or progress on a nonsteroidal aromatase inhibitor (NSAI) are limited. The BOLERO-2 trial supports the activity of everolimus (EVE; an oral mammalian target of rapamycin [mTOR] inhibitor) added to the steroidal aromatase inhibitor exemestane (EXE) to prolong progression-free survival (PFS) in this patient population. Long-term PFS and survival data are awaited. Methods: BOLERO-2 is a phase III double-blind, randomized, international trial comparing EVE (10 mg once daily) plus EXE (25 mg once daily) versus placebo (PBO) plus EXE in postmenopausal women with advanced ER+ BC progressing or recurring after NSAIs (letrozole or anastrozole). Patients were randomized (2:1) to EVE + EXE or PBO + EXE. The primary endpoint was PFS by local investigator assessment. Main secondary endpoints included centrally assessed PFS, overall survival (OS), safety, bone turnover, and overall response rate (ORR). Results: Baseline disease characteristics including tumor burden and prior cancer therapy were well balanced between treatment arms (N = 724). Median PFS was doubled and response rates were consistently improved with EVE + EXE (n = 485) vs PBO + EXE (n = 239) in interim analyses. Median PFS by local assessment was ~3 mo with PBO + EXE vs 6.9 mo (hazard ratio [HR] = 0.43; P < .0001) and 7.4 mo (HR = 0.44; P < .0001) with EVE + EXE at 7.5 mo and 12.5 mo follow-up, respectively. Fewer deaths were reported with EVE + EXE (17.2%) vs PBO + EXE (22.7%) at 12.5 mo follow-up. Safety profiles were consistent with previous reports for mTOR inhibitors. PFS data including 528 events (protocol-specified final analysis), and updated OS and safety data will be presented. Conclusions: Adding EVE to EXE markedly prolonged PFS in patients with NSAI-refractory advanced ER+ BC. There were fewer deaths among patients receiving EVE, and further follow-up will evaluate the effect of EVE on OS.

A prospective, randomized, double-blind comparison study of smooth vs. rough stems using cement fixation: minimum 5-year follow-up

2004 ◽  
Vol 19 (2) ◽  
pp. 254
Author(s):  
Vijay Rasquinha ◽  
Chitranjan Ranawat ◽  
Vipul Dua ◽  
Amar Ranawat ◽  
Jose Rodriguez
Keyword(s):  
Comparison Study ◽  
Double Blind ◽  
Blind Comparison

scholarly journals fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation

2021 ◽  
Vol 12 ◽  
Author(s):  
Micha Keller ◽  
Jana Zweerings ◽  
Martin Klasen ◽  
Mikhail Zvyagintsev ◽  
Jorge Iglesias ◽  
...  
Keyword(s):  
Cognitive Reappraisal ◽  
Symptom Improvement ◽  
Double Blind ◽  
Brain Responses ◽  
Improved Learning ◽  
And Gender ◽  
Blind Comparison ◽  
Left Target ◽  
The Right

Affective disorders are associated with maladaptive emotion regulation strategies. In particular, the left more than the right ventrolateral prefrontal cortex (vlPFC) may insufficiently regulate emotion processing, e.g., in the amygdala. A double-blind cross-over study investigated NF-supported cognitive reappraisal training in major depression (n = 42) and age- and gender-matched controls (n = 39). In a randomized order, participants trained to upregulate either the left or the right vlPFC during cognitive reappraisal of negative images on two separate days. We wanted to confirm regional specific NF effects with improved learning for left compared to right vlPFC (ClinicalTrials.gov NCT03183947). Brain responses and connectivity were studied with respect to training progress, gender, and clinical outcomes in a 4-week follow-up. Increase of vlPFC activity was stronger after NF training from the left- than the right-hemispheric ROI. This regional-specific NF effect during cognitive reappraisal was present across patients with depression and controls and supports a central role of the left vlPFC for cognitive reappraisal. Further, the activity in the left target region was associated with increased use of cognitive reappraisal strategies (r = 0.48). In the 4-week follow-up, 75% of patients with depression reported a successful application of learned strategies in everyday life and 55% a clinically meaningful symptom improvement suggesting clinical usability.

Thylin - follow-up

1964 ◽  
Vol 2 (20) ◽  
pp. 80-80
Keyword(s):  
Rheumatoid Arthritis ◽  
Side Effects ◽  
Chronic Arthritis ◽  
The Other ◽  
Double Blind ◽  
Previous Therapy ◽  
Blind Comparison

Since we discussed nifenazone (Thylin - West Pharmaceuticals) last April (Drug & Therap. Bull. 2, 26) Hart and Boardman1 have reported a trial of the drug, the first published in Britain. They substituted nifenazone 750–2000 mg daily for phenylbutazone, oxyphenbutazone or salicylates in 26 patients with painful chronic arthritis, mostly rheumatoid. In 18 of these the symptoms became worse; 7 showed some benefit, but less than with the previous therapy, and in one the improvement was comparable with that obtained from phenylbutazone 300 mg daily. Various side effects e.g. dyspepsia, nausea, mouth ulcers, rash occurred in 8 of the 26 patients. In 10 further patients with rheumatoid arthritis a double-blind comparison was made between nifenazone 500 mg three times daily and placebo tablets. Two patients withdrew from the trial; among the other 8, symptoms improved in one, but 7 noted no change. Objective criteria showed no significant improvement. The results of larger trials of the drug, to be published next November, will be awaited with interest.

Randomised double-blind comparison of the incidence of tardive dyskinesia in patients with schizophrenia during long-term treatment with olanzapine or haloperidol

1999 ◽  
Vol 174 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Charles M. Beasley ◽  
Mary Anne Dellva ◽  
Roy N. Tamura ◽  
Hal Morgenstern ◽  
William M. Glazer ◽  
...  
Keyword(s):  
Relative Risk ◽  
Tardive Dyskinesia ◽  
Incidence Rate ◽  
Involuntary Movement ◽  
Term Treatment ◽  
Double Blind ◽  
Long Term Treatment ◽  
Blind Comparison ◽  
One Year

BackgroundTardive dyskinesia is important in the side-effect profile of antipsychotic medication.AimsThe development of tardive dyskinesia was evaluated in patients treated with double-blind, randomly assigned olanzapine or haloperidol for up to 2.6 years.MethodsTardive dyskinesia was assessed by the Abnormal Involuntary Movement Scale (AIMS) and Research Diagnostic Criteria for Tardive Dyskinesia (RD-TD); it was defined as meeting RD-TD criteria at two consecutive assessments. The risk of tardive dyskinesia, the relative risk, incidence rate, and incidence rate ratio were estimated.ResultsThe relative risk of tardive dyskinesia for the overall follow-up period for haloperidol (n=522) v. olanzapine (n=1192) was 2.66 (95% CI=1.50–4.70). Based on data following the initial six weeks of observation (during which patients underwent medication change and AIMS assessments as frequently as every three days), the one-year risk was 0.52% with olanzapine (n=513) and 7.45% with haloperidol (n=114). The relative risk throughout this follow-up period was 11.37 (95% Cl=2.21–58.60).ConclusionOur results indicated a significantly lower risk of tardive dyskinesia with olanzapine than with haloperidol.

Double Blind Comparison of Mefenamic Acid and Acetaminophen (Paracetamol) in Migraine

Cephalalgia ◽  
1983 ◽  
Vol 3 (2) ◽  
pp. 129-134 ◽  
Author(s):  
R. C. Peatfield ◽  
R. G. Petty ◽  
F. Clifford Rose
Keyword(s):  
Mefenamic Acid ◽  
Analogue Scale ◽  
Double Blind ◽  
Inflammatory Drug ◽  
Pain Pathways ◽  
The Mean ◽  
Blind Comparison ◽  
Lost To Follow Up

We have assessed the role of mefenamic acid, a non-steroidal anti-inflammatory drug known to inhibit both the synthesis and actions of prostaglandins, as an analgesic in migraine by comparing it with the established analgesic paracetamol (acetaminophen) in a double-blind cross-over trial. Forty ambulant migraine patients were supplied with oral meditation for six consecutive attacks; metoclopramide 10 mg was administered in all attacks, and paracetamol 500 mg and mefenamic acid 500 mg for three attacks each. The patients recorded the intensity of the headache at the time the meditation was taken, and again after 3 hours, on a linear analogue scale. Twenty-two patients completed the trial satisfactorily. Seven had insufficient attacks and the remainder were lost to follow-up. The mean reduction in headache intensity was 36 ± 11% on mefenamic acid and 27 ± 10% (both mean ± SEM) on paracetamol. While this difference is not quite statistically significant (0.1 > P > 0.05) there still remains a 28% probability that mefenamic acid is twice as potent as an analgesic. The responses in each individual patient to the two drugs were very closely correlated (P < 0.001). Our failure to demonstrate a convincing difference between the two analgesics leads us to speculate that peripheral prostaglandin mediated pain pathways, in which paracetamol is inactive, may be less important than central pathways, which are inhibited by both drugs.

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