6 results
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
Primary Exploratory Objective:* To explore the effect of Lactobacillus casei strain Shirota (LcS) on small intestinal microbiota profiles.Secondary Exploratory Objectives:* To explore the differences between the effect of LcS on small intestinal and…
To measure saturation and desaturation of the cavernosal tissue with a cutaneousplaced penile sensor, before and during full rigidity. To validate discriminatingsensor-readings between flaccid state and full rigidity of the penis. To explore the…
To further evaluate the safety, efficacy and device performance of the ACURATE neo2* aortic bioprosthesis and ACURATE neo2* transfemoral delivery system in 2000 consecutive patients with severe aortic stenosis according to VARC-3 criteria.