Controlled clinical trials
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Control Clin Trials · Dec 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialSymptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.
Patients may be asked to register a symptom daily in clinical trials. A problem associated with this kind of registration is that patients do not always fill in the diary at the appropriate time. As there is evidence showing that memory is unreliable, this undermines the entire purpose of collecting daily data on paper diaries. We aimed to compare accuracy, autocorrelations of consecutive entries, and responsiveness in paper diaries (P-Diaries) with electronic diaries (E-Diaries) and telephone diaries (T-Diaries). ⋯ The results are consistent with the suggestion that data in the P-Diaries are not filled in at the appropriate time. Use of E-Diaries or T-Diaries improves quality and is recommended in future clinical trials.
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Control Clin Trials · Feb 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialCloseout of four phase II Vanguard trials and patient rollover into a large international phase III HIV clinical endpoint trial.
Large phase III clinical trials typically require many years of planning and preparation. During this time, proposed study methods and overall trial feasibility can be assessed in smaller pilot studies. However, the patients enrolled in these pilot studies are not routinely included in the larger study. ⋯ Specifically, the reconsent process, the data collection transition plan, and the steps taken to minimize bias due to differential reconsent according to the assigned treatment arm in the phase II trial are described. The procedures employed are relevant to the reconsent of patients for long-term follow-up at the completion of clinical trials. Control Clin Trials 2001;22:42-48
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Control Clin Trials · Aug 1998
Randomized Controlled Trial Multicenter Study Clinical TrialRationale and design for the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial.
The Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial is a randomized, prospective, double-blind, parallel-group, two-arm, actively controlled, multicenter, international 5-year clinical trial involving 15,000 patients. CONVINCE will compare the incidence of fatal or nonfatal myocardial infarction (MI), fatal or nonfatal stroke, or cardiovascular-disease-related death in two antihypertensive treatment regimens. One treatment arm begins with controlled onset-extended release (COER)-verapamil, which has its major antihypertensive effect 6-12 hours after administration. ⋯ Although most patients switch from an established antihypertensive medication to randomized treatment, untreated patients with stages I-III hypertension (SBP between 140 and 190 or DBP between 90 and 110 mm Hg) are eligible. Outcomes are monitored by an independent Data and Safety Monitoring Board. Enrollment began during the third quarter of 1996, and follow-up is to be completed in the third quarter of 2002.
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Control Clin Trials · Aug 1998
Randomized Controlled Trial Multicenter Study Clinical TrialSystemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations (SCCOPE): rationale and design of an equivalence trial. Veterans Administration Cooperative Trials SCCOPE Study Group.
The Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations Trial (SCCOPE) was a randomized, double-blind, placebo-controlled, multicenter trial sponsored by the U. S. Department of Veterans Affairs Cooperative Studies Program. ⋯ The primary endpoint of the study was treatment failure, defined as death, intubation with mechanical ventilation, hospital readmission for COPD, or intensification of pharmacologic therapy. Secondary endpoints included length of hospital stay, changes in FEV1, and changes in dyspnea score. We also evaluated possible adverse effects from systemic corticosteroids.
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Control Clin Trials · Feb 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialStroke prevention trial in sickle cell anemia.
Stroke occurs in 7-8% of children with Sickle Cell Disease (Hb SS) and is a major cause of morbidity. Rates of recurrence have been reduced from 46-90% to less than 10% through chronic blood transfusions. Prevention of first stroke, however, would be preferable because even one stroke can cause irreversible brain injury. ⋯ The sample size is sufficient to detect 70% reduction in the primary endpoint at 90% power. This trial will determine if transfusion is effective in the primary prevention of stroke. Secondary aims may further the understanding of the effects of transfusion on the brain and guide future research into cerebrovascular disease in Hb SS.