Contemporary clinical trials
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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.
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Contemp Clin Trials · Sep 2014
Randomized Controlled TrialPerioperative antihypertensive treatment in patients of spontaneous intracerebral hemorrhage (PATICH): a clinical trial protocol.
The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis. Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome. However, study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient. ⋯ Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery. Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke, separate rate of death and dependency at 90 days, health related quality of life (HRQoL) at 90 days, incidence of other vascular events, and days of hospitalization. Dependency is defined by a score of 3-5 based on the modified Rankin Scale (mRS).
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Contemp Clin Trials · Sep 2014
Randomized Controlled TrialA protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.
Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels. ⋯ Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.