35 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…
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 (…
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 evaluate the safety, feasibility and efficacy of an 8-week remotely supervised home-based maintenance exercise training program following pulmonary rehabilitation in patients with COPD.
To investigate the effects of ICIs (anti-CTLA4, anti-PD1, combination anti-CTLA4/PD1) on vascular inflammation (PET-CT) in stage III melanoma patients. We hypothesize that the increase in vascular inflammation will be greater in the exposure group…
1. To study the possibility to detect gynaecological malignancies and endometriosis in vaginal self-swabs, Pap smears and blood of women with gynaecological cancer or endometriosis, using MeD-seq and MeD-scan assays, in order to develop…
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…
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…
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…
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 -…
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 primary objective is to investigate if the stress-induced dynamics across stress systems are impaired in patients with CT-related depression compared to non-CT-related depression and healthy controls. The secondary objective is to examine how…
The aim of the study is:1) To test the effectiveness and cost-effectiveness of KIT for adolescents with (s)PTSD and comorbid symptoms. 2) To compare the outcomes from the current study with outcomes we have collected in two previous randomized…
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…
The LIMONCELLO study aims to assess the effect and cost-effectiveness of TMPC compared to usual care.
The primary objective is to explore whether central sensitization and/or abnormal CPM responses are present in (a subgroup of) patients who will receive shoulder arthroplasty for osteoarthritis, and whether shoulder arthroplasty produces change in…
The aim of this research proposal is to examine the effect of different ISIs on mTc-MEPs.Primary research question: What is the effect of different interstimulus intervals (ISIs) on mTc-MEP thresholds, peak-to-peak amplitudes, and area under the…
To study the kinetics of the vaccine-induced antibody response against HPV16/18 after a two-dose schedule by measuring these antibody responses at approximately 7, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months following the first dose of HPV-…
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…