5 results
The primary objective of the present study is to establish the histological effects of givinostat versus placebo administered over 12 months. The secondary objectives of this study are the following: - To establish the macroscopic muscle effects of…
- To examine the safety and feasibility (i.e. technical end result) of using OviTex core PGA during VMR - To assess perioperative complications- To assess 90-day morbidity
Primary objective:* To establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects.Secondary objectives:* To assess the safety and tolerability of givinostat versus…
The primary objective is to investigate the validity of the volumes measured by the Hexoskin shirt relative to a (mobile) spirometer in healthy subjects and in COPD patients. Secondary objective are to determine reliability of the Hexoskin shirt…
Main study parameter/endpoint phase II- Post-operative morbidity measured by reoperations, reinterventions, re-admissions, serious adverse events, Clavien Dindo classification and CTS classification. - The rate of rectal prolapse recurrence and…