PurposeTo assess the efficacy and safety of macitentan in pts with PH post-LVAD.MethodsSOPRANO (NCT02554903) was a double-blind, randomized, study 10 mg once-daily vs placebo. Pts were ≥18 years LVAD implanted within 90 days prior to randomization, had mean pulmonary arterial pressure (mPAP) ≥25 mmHg, artery wedge (PAWP) ≤18 mmHg vascular resistance (PVR) >3 Wood units (WU). The primary endpoin...

BACKGROUND Post-lunch dip is a well-known phenomenon that results in a substantial deterioration in function and productivity after lunch. OBJECTIVES To assess whether a new herbal-based potentially wake-promoting beverage is effective in counteracting somnolence and reduced post-lunch performance. METHODS Thirty healthy volunteers were studied on three different days at the sleep clinic. O...

BackgroundThere are no approved therapies for cough in patients with idiopathic pulmonary fibrosis (IPF). In this small crossover trial we administered nalbuphine extended-release tablets (NAL ER) as a potential therapy such patients.MethodsThis randomized, double-blind, placebo-controlled, involved two 22-day treatment periods ER→placebo and placebo→NAL separated by 2-week washout period. NAL ...

A simulated intervention (often a drug but potentially other interventions) used as a control/comparison in research studies. As suggested in the title of a book on the subject (Shapiro & Shapiro, 2000), the effects of such treatment can be powerful (what is termed to placebo response or effect). In drug studies, for example, the use of a placebo (inert agent that is packaged so as to be indist...