Lancet
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Randomized Controlled Trial Multicenter Study Clinical Trial
Recombinant bactericidal/permeability-increasing protein (rBPI21) as adjunctive treatment for children with severe meningococcal sepsis: a randomised trial. rBPI21 Meningococcal Sepsis Study Group.
Endotoxin is a primary trigger of the inflammatory processes that lead to shock, multiorgan failure, and purpura fulminans in meningococcal sepsis. Bactericidal/permeability-increasing protein (BPI) is a natural protein, stored within the neutrophil granules, that binds to and neutralises the effects of endotoxin in vitro, in laboratory animals, and in humans. To establish whether a recombinant 21-kDa modified fragment of human BPI (rBPI21), containing the active antimicrobial and endotoxin-neutralising moiety, would decrease death and long-term disability from meningococcal sepsis, we did a randomised, double-blind, placebo-controlled trial of rBPI21 in children with severe meningococcal sepsis. ⋯ Because most deaths occurred in the interval between identification of patients and study drug administration, the mortality rate in the placebo group was substantially lower than predicted. The trial was therefore underpowered to detect significant differences in mortality. However, patients receiving rBPI21 had a trend towards improved outcome in all primary outcome variables. Given the excellent severity match between placebo and rBPI21 groups at study entry, the results overall indicate that rBPI21 is beneficial in decreasing complications of meningococcal disease.
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Randomized Controlled Trial Comparative Study Clinical Trial
Alternative strategies for stroke care: a prospective randomised controlled trial.
Organised specialist care for stroke improves outcome, but the merits of different methods of organisation are in doubt. This study compares the efficacy of stroke unit with stroke team or domiciliary care. ⋯ Stroke units are more effective than a specialist stroke team or specialist domiciliary care in reducing mortality, institutionalisation, and dependence after stroke.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Comparison of vasopeptidase inhibitor, omapatrilat, and lisinopril on exercise tolerance and morbidity in patients with heart failure: IMPRESS randomised trial.
We aimed to assess in patients with congestive heart failure whether dual inhibition of neutral endopeptidase and angiotensin-converting enzyme (ACE) with the vasopeptidase inhibitor omapatrilat is better than ACE inhibition alone with lisinopril on functional capacity and clinical outcome. ⋯ Our findings suggest that omapatrilat could have some advantages over lisinopril in the treatment of patients with congestive heart failure. Thus use of vasopeptidase inhibitors could constitute a potentially important treatment for further improving the prognosis and well being of patients with this disorder.
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Randomized Controlled Trial Clinical Trial
Tri-iodothyronine treatment in children after cardiac surgery: a double-blind, randomised, placebo-controlled study.
Serum thyroid hormone concentrations decline transiently during critical illness and after surgical procedures. We investigated prospectively the endocrine and haemodynamic effects of tri-iodothyronine treatment after cardiopulmonary bypass operations in children with congenital cardiac malformations. ⋯ Treatment of children with tri-iodothyronine after cardiopulmonary bypass operations raises tri-iodothyronine plasma concentrations and improves myocardial function especially in patients with low postoperative cardiac output without adverse events, and without delaying postoperative recovery of thyroid function. Furthermore, tri-iodothyronine reduces the need for postoperative intensive care.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of wet combing with malathion for treatment of head lice in the UK: a pragmatic randomised controlled trial.
Concern about the effectiveness and toxicity of insecticide lotions has led to promotion of mechanical methods to remove head lice. We compared the effectiveness of "bug-busting" (wet combing with a fine-toothed comb) and malathion lotion. ⋯ Malathion lotion was twice as effective as bug-busting, even in an area with intermediate resistance. Policies advocating bug-busting as first-line treatment for head lice in the general population are inappropriate. Assessment of the outcome of treatment 1-2 weeks after completion is essential for successful management. Only about 50% of participants complied fully with treatment, so future trials should be pragmatic in design, avoid false incentives, and study representative samples of children.