48 results
This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…
Studies examining the effect of couple therapy or couple-based interventions in treatment for personality disorder are very scarce and more research is required. Therefore, the present study examines the effect of couple-based interventions in…
The main objective is to examine the change in 68Ga-exendin tracer accumulation in the pancreas (i.e. beta cell mass) after RYGB by quantitative analysis of PET images before and one year after RYGB in morbid obese patients with type 2 diabetes.
Primary ObjectiveTo demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in the first-line treatment of PD-L1 positive patients with aRCC.Secondary Objectives* To demonstrate that…
The Check@Home consortium aims to set up a roadmap and infrastructure for a (cost-)effective program to early detect atrial fibrillation and chronic kidney disease (defined by elevated albuminuria) in the general population. Furthermore, the project…
The primary objective is to perform a clinical validation of dried blood spot microsampling of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax. The secondary objective is to test the feasibility of home monitoring (…
Main objective: Develop a protocol to reproducibly infect mosquitoes with blood from human study participants undergoing asexual blood stage CHMI with the P. vivax clone PvW1.Secondary objectives: Maximize mosquito infection rate with PvW1 by I)…
Primary objective1. Assess that FAF can visualize the irradiated retina effects at an early stage after Ru-106 brachytherapy and PBT. Secondary objective1. Assess if these FAF-images can be correlated to the treatment plan.2. Correlate the observed…
To capture changes in cortical excitability, by using VEP-EEG recordings at home, in the pre-ictal phase of a migraine attack to serve as an early marker for upcoming attacks.
Clinical validation of capillary microsampling with finger pricks for olanzapine. The validation method is performed in accordance with the EM guideline. In this process, the analytical methods are assessed for selectivity, carry-over, lower limit…
To investigate the influence of flucloxacillin treatment on CYP - and UGT substrate plasma concentration, to gain further understanding of potential clinically relevant drug-drug interactions with flucloxacillin.
The aim of this study is to investigate the feasibility and safety of an accelerated protocol for patients undergoing liver surgery compared to a retrospective cohort of patients who followed the standard ERAS care for liver surgery. In this…
The objective of this study is to establish the clinical performance of VENTANA PD-L1 (SP263) CDx Assay as a companion diagnostic (CDx) for the identification of patients with NSCLC who may benefit from treatment with [redacted]. This clinical…
Primary objectives:1. To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction.Secondary objectives: 2. To compare change in quality of life, New York Heart Association functional class, 6-minute walking…
The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
Hand function impairment in systemic sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) study
Primary Objective: Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-upSecondary Objective(s):-…
To ascertain differences in mitochondrial and microcirculatory parameters between healthy older adults (> 65 years and ASA1-2) and more vulnerable elderly patients (> 65 years and ASA 3-4).
We will assess safety (potential adverse events related to phototherapy using Jauni, e.g. skin injuries, hyperthermia, or hypothermia) and effectiveness (e.g. rate of lowering of bilirubin levels, duration of phototherapy need) of phototherapy using…
To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergo-ing pace-and-ablate strategy with LBBAP.Secondary objectives: -…
Primary Objective• P1. Verify if self-administered eye scanning using a smartphone application, using native key features (alone or in predefined combination(s)), can indicate use of each medicinal product (D1-D2).Secondary Objectives• S1. Verify if…