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Combining different phases in the development of medical treatments within a single trial.
An adaptive two-stage design is proposed for the situation of multiple treatments to be compared with a control, allowing integration of both steps within a single confirmatory trial controlling the multiple level alpha. Expand
Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial
Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy and new strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. Expand
Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial.
The study findings do not support an advantage for the use of conscious sedation for early neurological improvement among patients receiving stroke thrombectomy among patients with acute ischemic stroke in the anterior circulation. Expand
Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial.
H. perforatum extract WS 5570 was found to be safe and more effective than placebo for the treatment of mild to moderate depression and led to global reduction of depression-related core symptoms. Expand
St. John's wort in mild to moderate depression: the relevance of hyperforin for the clinical efficacy.
Results show that the therapeutic effect of St. John's Wort in mild to moderate depression depends on its hyperforin content, which was superior to placebo in alleviating depressive symptoms according to HAMD reduction. Expand
Sustained Effects of a Mindfulness-Based Stress-Reduction Intervention in Type 2 Diabetic Patients
MBSR intervention achieved a prolonged reduction in psychosocial distress and improved health status of patients with type 2 diabetes and albuminuria and will be followed up further. Expand
A unifying approach for confidence intervals and testing of equivalence and difference
SUMMARY General families of null hypotheses are defined which refer to problems of testing equivalence and difference between treatments. Corresponding confidence intervals have been proposed in theExpand
Affective disorders and survival after acute myocardial infarction. Results from the post-infarction late potential study.
The findings indicate that affective disorders play an important role in the post-acute phase after AMI although the extent of myocardial infarction and behaviour responses are not significantly related to one another. Expand
A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer's type.
The trial did not show efficacy of GbE, however, the lack of decline of the placebo patients may have compromised the sensitivity of the trial to detect a treatment effect, and the study remains inconclusive with respect to the efficacy of ginkgo biloba extract. Expand
Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation
This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation. Expand