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Thorac Cardiovasc Surg · Apr 2012
Multicenter StudyRisk factors for distal Contegra stenosis: results of a prospective European multicentre study.
Objectives The EUCon study was designed to identify risk factors for distal anastomotic stenosis after bovine jugular vein (Contegra) implantation in children. Methods Between March 2006 and August 2008, 104 devices were implanted in nine European centers. Preoperative, intraoperative, and follow-up data (at discharge, 6, 12, 24 months) including standardized echocardiography were prospectively registered, source data verified and collected in a central database. ⋯ Age <2 years was the only invariably significant risk factor (p = 0.044); "Clustering By Response" found young anticoagulated patients with oversized conduits to be at a higher risk than the others (p = 0.018, OR = 3.2). Conclusion Patient age is the main risk factor for development of distal anastomosis stenosis after Contegra implantation. The influence of the other investigated factors is too small to be proven in 104 patients after 2 years, or other risk factors must be taken into consideration to explain outcome differences among recipients under 2 years.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial.
Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited. ⋯ Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy. These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence.
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British journal of cancer · Apr 1998
Multicenter Study Clinical TrialImproving survival in recurrent medulloblastoma: earlier detection, better treatment or still an impasse?
Early detection of relapse has been advocated to improve survival in children with recurrent medulloblastoma. However, the prognostic factors and the longer term outcome of these patients remains unclear. Pattern of recurrences were analysed in three consecutive protocols of the Société Française d'Oncologie Pédiatrique (1985-91). ⋯ The median survival time after progression was 5 months (<1-41 months), and only two patients remained alive at time of follow-up. Length of survival is primarily related to some specific patterns of relapse (time from diagnosis to recurrence, circumstances of relapse, extent of relapse) and to the response to salvage therapy. No evidence of long-term benefit appeared from any form of treatment.
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Multicenter Study Observational Study
Usefulness of universal beta-blocker therapy in patients after ST-elevation myocardial infarction.
The use of beta-blockers (BB) in the context of ST-segment elevation myocardial infarction (STEMI) was a universal practice in the pre-reperfusion era. Since then, evidence of their use for secondary prevention after STEMI is scarce. Our aim is to determine treatment results associated with BB therapy after a STEMI at 1-year follow-up in a contemporary nationwide cohort. ⋯ However, after adjustment for significant covariates, this association was lost (HR 0.73, CI 95% 0.51-1.04, P = .081). In patients with preserved (HR 0.73, CI 95% 0.51-1.04, P = .081) and mid-range (HR 1.01, CI 95% 0.64-1.61, P = .959) left ventricular ejection fraction (LVEF), the primary outcome was similar between the 2 groups, while in patients with reduced LVEF, the BB group presented a better prognosis, with fewer patients reaching the primary outcome (HR 0.431, CI 95% 0.262-0.703, P = .001). BB universal therapy after STEMI has not proved useful, but it seems to be beneficial in patients with reduced LVEF.
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Randomized Controlled Trial Multicenter Study
Phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of a H4 R-antagonist (JNJ-39758979) in Japanese adults with moderate atopic dermatitis.
This trial was conducted to evaluate the safety and efficacy of the H4 R-antagonist JNJ-39758979 in adult Japanese patients with moderate atopic dermatitis (AD). Eligible patients were randomly assigned to JNJ-39758979 300 mg, 100 mg or placebo once daily for 6 weeks in this phase 2a, double-blind, multicenter, placebo-controlled study. Primary efficacy was assessed via week-6 Eczema Area and Severity Index (EASI) scores. ⋯ Except for neutropenia, no clinically relevant changes in laboratory values were observed. Although not conclusive, findings suggest H4 R-antagonism may be beneficial for AD, particularly in controlling pruritus. JNJ-39758979 appears to be associated with drug-induced agranulocytosis, likely an off-target effect.