The New England journal of medicine
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Randomized Controlled Trial Multicenter Study Clinical Trial
Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus.
Type 1 diabetes mellitus is a chronic autoimmune disease caused by the pathogenic action of T lymphocytes on insulin-producing beta cells. Previous clinical studies have shown that continuous immune suppression temporarily slows the loss of insulin production. Preclinical studies suggested that a monoclonal antibody against CD3 could reverse hyperglycemia at presentation and induce tolerance to recurrent disease. ⋯ Treatment with hOKT3gamma1(Ala-Ala) mitigates the deterioration in insulin production and improves metabolic control during the first year of type 1 diabetes mellitus in the majority of patients. The mechanism of action of the anti-CD3 monoclonal antibody may involve direct effects on pathogenic T cells, the induction of populations of regulatory cells, or both.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of insulin in relatives of patients with type 1 diabetes mellitus.
It is unknown whether insulin therapy can delay or prevent diabetes in nondiabetic relatives of patients with diabetes. ⋯ In persons at high risk for diabetes, insulin at the dosage used in this study does not delay or prevent type 1 diabetes.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Tissue plasminogen activator in cardiac arrest with pulseless electrical activity.
Coronary thrombosis and pulmonary thromboembolism are common causes of cardiac arrest. We assessed whether the administration of tissue plasminogen activator (t-PA) during cardiopulmonary resuscitation would benefit patients with cardiac arrest and pulseless electrical activity of unknown or presumed cardiovascular cause. ⋯ We found no evidence of a beneficial effect of fibrinolysis in patients with cardiac arrest and pulseless electrical activity of unknown or presumed cardiovascular cause. Our study had limited statistical power, and it remains unknown whether there is a small treatment effect or whether selected subgroups may benefit.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Immediate repair compared with surveillance of small abdominal aortic aneurysms.
Whether elective surgical repair of small abdominal aortic aneurysms improves survival remains controversial. ⋯ Survival is not improved by elective repair of abdominal aortic aneurysms smaller than 5.5 cm, even when operative mortality is low.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms.
Two clinical trials, one British and one American, have shown that early, prophylactic elective surgery does not improve five-year survival among patients with small abdominal aortic aneurysms. We report long-term outcomes in the United Kingdom Small Aneurysm Trial. ⋯ Among patients with a small abdominal aortic aneurysm, we found no long-term difference in mean survival between the early-surgery and surveillance groups, although after eight years, total mortality was lower in the early-surgery group. This difference may be attributed in part to beneficial changes in lifestyle adopted by members of the early-surgery group.