Contemporary clinical trials
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Contemp Clin Trials · Jan 2015
Randomized Controlled TrialThe keys to healthy family child care homes intervention: study design and rationale.
Obesity is a major public health problem for which early preventive interventions are needed. Large numbers of young children are enrolled in some form of child care program, making these facilities influential environments in children's development. Family child care homes (FCCH) are a specific type of child care in which children are cared for within the provider's own residence. FCCHs serve approximately 1.5 million children in the U.S.; however, research to date has overlooked FCCH providers and their potential to positively influence children's health-related behaviors. ⋯ Keys is an innovative approach to promoting healthy eating and physical activity in young children. The intervention operates in a novel setting, targets children during a key developmental period, and addresses both provider and child behaviors to synergistically promote health.
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Contemp Clin Trials · Jan 2015
Randomized Controlled Trial Multicenter StudyRationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial).
Traumatic brain injury (TBI) is a major public health problem recently, however, no intervention showing convincing efficacy. Therapeutic hypothermia with a relatively long duration (more than 48 h), as a promising treatment measure, might improve the patient outcome following severe TBI. ⋯ Long-term hypothermia is recommended by most recent studies and its efficacy urgently needs to be established in randomized controlled settings. The LTH-1 trial, together with other ongoing studies, will present more evidence for optimal use of hypothermia in severe TBI patients.
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Contemp Clin Trials · Jan 2015
Randomized Controlled Trial Multicenter StudyRationale and design: impact of intravascular ultrasound guidance on long-term clinical outcomes of everolimus-eluting stents in long coronary lesions.
Although the use of drug-eluting stents (DESs) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization, treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis. Intravascular ultrasound (IVUS) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention. However, it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes. ⋯ This study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance.