The primary objective of this study was to evaluate the rate of total brain atrophy (TBA) with serial magnetic resonance imaging (MRI), using the Brain Boundary Shift Integral (BBSI), in patients with probable Alzheimer's disease (AD) over the course of 52 weeks of treatment with memantine or placebo. This was a multi-national, randomized, double-blind, placebo-controlled, fixed-dose 1-year stu...

OBJECTIVES This study sought to examine the effects of vasopressin V2 receptor antagonism with tolvaptan on the changes in left ventricular (LV) volumes over time. BACKGROUND Vasopressin levels may be increased in patients with heart failure (HF) and may be a factor driving the progression of HF. METHODS This was a multicenter, randomized, double-blind, placebo-controlled trial conducted to...

OBJECTIVE Herpes simplex virus type 2 (HSV-2) suppression has been shown to reduce HIV-1 disease progression in non-pregnant women and men, but effects on pregnant and postpartum women have not been described. METHODS We analyzed data from a cohort of Kenyan women participating in a randomized clinical trial of HSV-2 suppression. Pregnant HIV-1-seropositive, HSV-2-seropositive women who were ...

BACKGROUND Calcium and vitamin D may be inversely related to breast cancer risk, in part by affecting mammographic density. However, results from previous, mostly cross-sectional studies have been mixed, and there have been few randomized clinical trials of the effect of calcium and vitamin D supplementation on change in mammographic density. METHODS We assessed the effect of one year of supp...

PURPOSE To evaluate the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation. PATIENTS AND METHODS The patients who met Rome III diagnostic criteria for functional constipation were randomized in this multicenter, randomized, placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 g) ...

AIM To test whether melatonin reduces oxidative and inflammatory biomarkers in a closed-chest porcine model of acute myocardial infarction. MATERIALS AND METHODS Twenty pigs were randomized to receive a total dosage of 200 mg (0.4 mg/ml) of melatonin, or placebo immediately prior to reperfusion of a coronary artery balloon occlusion in a randomized, observer-blinded, placebo-controlled trial....

This randomized, single-blind, placebo-controlled study investigated the effect of ivabradine, a novel heart rate-lowering agent, on echocardiographic indices of left ventricular (LV) systolic function in patients with regional (coronary artery disease) or global (cardiomyopathy) LV dysfunction. Patients were randomized on an unequal basis to receive ivabradine 0.25 mg/kg (n = 31) or placebo (n...

BACKGROUND Pharyngocutaneous fistula is a common complication of total laryngectomy. We hypothesized that perioperative proton pump inhibitor (PPI) treatment could reduce the incidence of pharyngocutaneous fistulae. METHODS This prospective placebo-controlled double-blind randomized controlled trial compared PPI treatment (14 days enteral omeprazole) with a placebo in patients undergoing prim...

Abstract Background Acute cough in children often causes discomfort to and parents, reducing their quality of life. Despite the extensive utilization over-the-counter remedies for cough, efficacy most these treatments has not been confirmed. Methods We conducted a randomized, double blind, placebo-controlled clinical trial 106 with acute evaluate safety KalobaTUSS ® , paediatric syrup based on ...