27 results
Objective: This protocol describes a framework that will be used to create different studies. The general primary and secondary objectives of this protocol are stated below:Primary objective: Investigate the effect of surgery on the position and…
1) To determine if the 24 hour admission with TM can be omitted safely in the setting of CER for patients with low- and intermediate risk syncope (non-inferiority) 2) to determine the health care cost reduction (superiority), 3) additional…
The purpose of this study is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft System versus Gore Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI and (2) to evaluate whether training viewing strategies results in more efficient…
To evaluate the (cost-)effectiveness of SBRT (with active dose-sparing of the surgical site) followed by surgical stabilization with or without decompression within 24 hours for the treatment of symptomatic, unstable metastases of the cervical,…
We will combine four 7 Tesla MRI markers in extremely preterm infants (MRSI; SWI; PC-MRI; ihMT) to assess (1) if they can predict outcome until 2 years of age; (2) if they are of added value to 3 Tesla prematurity (Kidokoro et al., 2013) and (3) if…
The LIMONCELLO study aims to assess the effect and cost-effectiveness of TMPC compared to usual care.
The primary objective is to demonstrate efficacy of an extended remote monitoring intervention, including a TM app, HF nurse guided home care and multidisciplinary network collaboration using the Virtual Ward platform, on top of standard HF care…
To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…
Primary Objective: Investigate if a tailored diuretic algorithm based on Ur-Na has a positive effect on a composite endpoint of mortality, HF events (HFE) and a change in quality of life (QoL) (assessed with the Kansas city…
To investigate the effects of a 5-day diet with 30% caloric and 70% protein restriction on cardiotoxicity induced by anthracycline treatment in women with triple negative or hormone receptor-positive breast cancer. The biomarker high-sensitivity…
This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…
Primary objective (after 1 year)- To evaluate the effectiveness of the nurse-led GILL eHealth intervention in patients with serious mental illnessSecundary objectives (after 1 year)- Improve metabolic syndrome severity- Improve fitness, physical…
The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions foruse (IFU) conditions in aneurysms with a wide neck is superior to treatment with…
Part A: Determine the performance of using 4D DCE-BCT for tumour staging. Part B: Determine the performance of 4D DCE-BCT in monitoring of treatment response and prediction of final treatment outcome based on early response in patients that undergo…
This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.
The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…
The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…
This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…
This study has several objectives, in different (subsequent) study phases:• A1. Optimize and validate the technology of the VD to reach non-inferiority• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking• B2. Demonstrate…