Contemporary clinical trials
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Contemp Clin Trials · Nov 2014
Randomized Controlled Trial Multicenter StudyPREBIOUS trial: a multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: rationale and design.
Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. ⋯ The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
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Contemp Clin Trials · Nov 2014
Randomized Controlled Trial Comparative StudyA comparison among infusion of lidocaine and dexmedetomidine alone and in combination in subjects undergoing coronary artery bypass graft: a randomized trial.
Previous studies have reported the cardioprotective effect of dexmedetomidine and lidocaine. We compared the effect of lidocaine and dexmedetomidine infusion during off-pump coronary artery bypass graft (OPCAB). ⋯ Lidocaine infused at 2 mg/kg/h, but not dexmedetomidine infused at 0.3-0.7 μg/kg/h reduced postoperative myocardial injury marker levels compared with the control group. However, no other clinical benefits were observed.
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Contemp Clin Trials · Nov 2014
Randomized Controlled TrialDischarge information and support for veterans Receiving Outpatient Care in the Emergency Department: study design and methods.
An explicit goal of Patient Aligned Care Teams (PACTs) within the Veterans Health Administration is to promote continuity of care in primary care clinics and thereby reduce Emergency Department (ED) utilization; however, there has been little research to guide PACTs on how to accomplish this. ⋯ The results of this randomized, controlled trial with an Effectiveness-Implementation Type I Hybrid design will be directly relevant to the care of more than 500,000 high risk patients seen in Veterans' Affairs Medical Center (VAMC) EDs annually. Results will also be informative to health systems outside VA aiming to reduce ED use through accountable care organizations.
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Contemp Clin Trials · Nov 2014
Randomized Controlled TrialDesign of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.
The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. ⋯ The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group.
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Contemp Clin Trials · Sep 2014
Randomized Controlled Trial Multicenter Study Comparative StudyDesign considerations for point-of-care clinical trials comparing methadone and buprenorphine treatment for opioid dependence in pregnancy and for neonatal abstinence syndrome.
In recent years, the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome (NAS), which is caused by withdrawal from in-utero drug exposure. While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy, research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay (LOS) relative to methadone-maintenance. There is no "gold standard" treatment for NAS but there is evidence that buprenorphine, relative to morphine or methadone, treatment may reduce LOS and length of treatment. ⋯ This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS. The results could have a significant impact on practice.