5 results
Primary objectives:- To study the potential interaction of budesonide on the plasma exposure of cabazitaxelSecondary objectives:- To test the safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
Demonstrate the suitability of cardiorespiratory monitoring directly after birth using a novel, wireless, non-adhesive device.
The objective of this explorative study is to determine the feasibility of measuring dEMG with a belt in preterm and term born infants during routine caregiving. Feasibility is confirmed when heart rate and respiratory rate reach a predefined level…
To establish equivalence (non-inferiority) between monitoring performance of the Bambi Belt and the currently used cardio-respiratory monitoring device. The Bambi Belt is a potentially more patient friendly, wireless cardio-respiratory monitoring…