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Background We examined whether quarterly patient enrollment in a large multicenter clinical trials group could be modeled in terms of predictors including time parameters (such as long-term trends and seasonality), the…
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The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologically and…
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Background The aim of this study was to examine the determinants of publication and whether publication bias occurred in gastroenterological research. Methods A random sample of abstracts submitted to DDW, the major GI…
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Background Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies…
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The results and interpretations of the most recent controlled clinical trials on antihypertensive drugs have fuelled the debate about the drug that should be used to begin treatment for hypertension. Every comparison of…
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Clinical trialists and statisticians are very wary of subgroup analysis, for good reasons. Clinicians have to deal with situations in which subgroups of patients differ widely from one another in their prognosis and…
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The publication of the results of the Swedish Trial in Old Patients with Hypertension-2 (STOP-2) and the termination of the doxazocin arm of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack…
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The recent scientific session of the American College of Cardiology (ACC), held in Orlando, provided a forum for ongoing cardiovascular clinical trials from around the world. The high point was clearly the first ever…
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An explanation for the higher incidence of cardiovascular disease and heart failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) with doxazosin and the Vasodilator Heart…
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In light of the slow progress in developing effective therapies for ischemic stroke, magnetic resonance imaging techniques have emerged as new tools in stroke clinical trials. Rapid imaging with magnetic resonance…
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Are there fundamental deficiencies in the megatrial methodology?
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Background Readers may question the interpretation of findings in clinical trials when multiple outcome measures are used without adjustment of the p-value. This question arises because of the increased risk of Type I…
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Three clinical trials have recently focused on the benefits of lipid-regulating therapy in populations with normocholesterolaemia and low high-density lipoprotein (HDL)-cholesterol. Two secondary prevention studies…
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Analysis of subgroup results in a clinical trial is surprisingly unreliable, even in a large trial. This is the result of a combination of reduced statistical power, increased variance and the play of chance. Reliance…
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Biventricular pacing or resynchronisation therapy is a non-pharmacological therapy for patients with chronic heart failure. Since being originally described in 1994, biventricular pacing has become a subject of intense…
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Research Article: Current Controlled Trials in Cardiovascular Medicine
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The Losartan Heart Failure Survival Study (ELITE II) and the Valsartan Heart Failure Trial (Val-HeFT) both evaluated the efficacy and tolerability of a selective angiotensin II receptor antagonist on morbidity and…
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Background We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may…
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A common problem in clinical trials is the missing data that occurs when patients do not complete the study and drop out without further measurements. Missing data cause the usual statistical analysis of complete or all…
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Only a few randomized clinical trials have been performed so far in heart transplant recipients, mainly because of the relatively small number of heart transplants performed worldwide each year. The main focus of the…