4 results
This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
(1) To examine whether the exposure to BWL yields clinically significant reductions in CRF compared to exposure to dim white light in (non-)Hodgkin survivors. (2) To examine the effect of exposure to BWL compared to DWL on sleep quality and…