5 results
The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
Post-market clinical follow-up of a magnetic bone conduction implant (Cochlear Baha® Attract System)
This post-market clinical follow-up investigation aims to evaluate the usability and the mid- to long-term performance of the Baha Attract System in terms of hearing outcomes and safety. The objective is to compare the hearing performance with the…
Whether injection of corticosteroids with use of ultrasound in the cubital tunnel is effective in reducing the symptoms compared with patients with an ulnar neuropathy treated with an injection of NaCl 0.9 % (placebo). Both groups will get the usual…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…