UNLABELLED Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genodermatosis with severe blistering. No curative treatment is available. Scientific data indicated that epigallocatechin-3-gallate (EGCG), a green tea extract, might improve the phenotype of RDEB patients. In a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial, we evaluated a 4-month oral ...

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disorder affecting 5 % of children worldwide. A prevalent problem for children with ADHD is initial insomnia. The gold standard treatment to manage ADHD symptoms is stimulant medications, which may exacerbate the severity of existing initial insomnia. Currently, no gold standard treatment option exists for initi...

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...

In a randomized, head-to-head, placebo-controlled trial, we enrolled adults with obesity (body-mass index [the weight in kilograms divided by the square of height meters], 32 to 43) who did not have diabetes. After an 8-week low-calorie diet, participants were randomly assigned for 1 year one four strategies: moderate-to-vigorous–intensity exercise program plus placebo (exercise group); treatme...

The effect of treatment with percutaneous E(2) (100 μg/24 h) during 2 weeks perimenstrually on the number and severity of menstrual migraine attacks was studied in 27 women in a randomized, placebo-controlled, double-blind, crossover trial. We were not able to demonstrate any difference between E(2) supplementation and placebo on the number or severity of migraine attacks, but both regimens sho...

BACKGROUND Low vitamin D intake and levels have been associated with increased joint symptoms in some observational studies but the findings are mixed and evidence from randomized trials sparse. OBJECTIVE To evaluate the influence of supplemental calcium and vitamin D on joint symptoms in the Women's Health Initiative randomized, placebo-controlled, clinical trial. DESIGN In post hoc analys...

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 ...

Observational studies have led to speculation that antenatal vitamin D supplementation may reduce the risk of offspring atopic eczema, but currently there are no proven general population preventive interventions. In Maternal Vitamin Osteoporosis Study double-blind, randomized, placebo-controlled trial, we examined link between maternal (from 14 weeks’ gestation until delivery) with cholecalcif...