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A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation

Primary Objectives*To evaluate the safety and tolerability of multiple oral doses of GLPG1837 in subjects with CF and at least one copy of the S1251N mutation.Secondary Objectives*To assess changes in sweat chloride from baseline (Day 1) as the…

Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus

There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…

DW-MRI in mediastinal restaging after concomitant chemoradiotherapy and prognosis of trimodality treatment for stage IIIA/B NSCLC with mediastinal lymph node metastases and without supraclavicular lymph node metastases ; NSCLC Stadium IIIA/B N2/3

This study aims to investigate the feasability to use DW-MRI for mediastinal restaging after concomitant chemoradiotherapy and the feasabilitiy to predict whether or not mediastinal downstaging will be achieved during concomitant chemoradiotherapy…

Aortic Stenosis * Identification of high-risk valve pathology using STRESS physiology (AoS-STRESS)

2.1 Primary objectiveTo determine patterns of response in the transvalvular pressure gradient while altering transvalvular flow.2.2 Secondary objectives-To quantify any added value or differentiation from stress assessment of aortic stenosis…

Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet

Primary objective: To assess the impact of a low glycaemic load (GL) diet as compared to a *Western* diet on metabolic flexibility (the change in RQ) upon a hyperinsulinemic euglycemic clamp. Secondary objectives: 1) To assess the impact of low GL…

A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…

From expecting to experiencing: The role of parenting cognitions in the transition to parenthood

Study 1 is aimed to describe normative trajectories of parenting efficacy from pregnancy to early parenthood. Study 2 is focused on the question whether mental representations of attachment are protective in the context of parenting stress and its…

The treatment of coronary artery lesions using the PRO-Kinetic energy cobalt-chromium, bare-metal stent (BIOHELIX-I)

The primary objective of this study is to demonstrate the clinical performance of PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

Response to DDAVP In mild Hemophilia A patients, in Search for dEterminants

The aim of this project is to investigate the association between clinical and genetic factors and DDAVP response in MHA patients and to determine their relative contributions to the DDAVP response.

Technology in Motion (TIM): Unobtrusive assessment of motor (dys)function

The overall objective of this study is to develop patient friendly and unobtrusive techniques to characterize motor function. In this context we will use video cameras combined with depth sensors (RGB-D sensors, such as Microsoft KinectTM) and…

Diagnostics and mechanisms of titanium allergy

Primary Objective:Pilot study: Selection of the titanium derivatives which are capable of penetrating the skin, and thus can be used in the full study as patch test materials.Full study: To compare the results of three different diagnostic tests…

Near Infrared Spectroscopy Monitoring of Acute Ischemic Stroke Patients

Objective 1: To prospectively evaluate the utility of C-FLOW monitor to examine status of regional CBF and reperfusion in patients presenting with acute anterior circulation ischemic stroke syndrome. Objective 2: To assess the feasibility,…

Dose range finding pilot study for diagnostic patch testing with ME-PPD

Primary Objective: Pilot study to identify the optimal patch test concentration for detecting contact allergy to ME-PPD in subjects with a proven contact allergy to PPD, who may be allergic to ME-PPD. Hypothesis: In this study subjects will be…

Exploring the metabolic profile of neuroendocrine tumors

The aim of this study is to explore the added value of the indol profile in comparison to serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary…

Urinary markers for fetal growth restriction: the role of gaseous vasoactive molecules.

Hypothesis: gaseous signaling molecules influence placental vasomotor activity to compensate for hypoxemia. Metabolites of these vasoactive molecules can be found in the blood and urine and can indicate whether this (compensatory) mechanism is used…

89Zr-pembrolizumab-PET imaging in patients with locally advanced or metastatic melanoma or non-small cell lung cancer

Primary objective: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma or NSCLC. Secondary objectives: i) To evaluate pharmacokinetics of 89Zr-pembrolizumab; ii) To assess the…

Single center ethical protocol for donation of skin tissue and blood samples by patients suffering from psoriasis vulgaris for animal studies concerning development of new treatments for psoriasis vulgaris.

Collection of skin tissue and blood samples from patients with mild to moderate psoriasis for efficacy testing of a reference compound, for subsequent testing of a new therapeutic in a humanized mouse model.

Free circulating tumour DNA in patients with peritoneal metastases of colorectal origin and HIPEC therapy; LIBEC trial - a feasibility study

To evaluate the detection ctDNA in patients with PC of colorectal origin undergoing cytoreductive surgery and HIPEC at time of diagnosis in a feasibility trial This study is considered feasible:1. If in at least 70% of the patients ctDNA status…

MRKH syndrome caused by Intrauterine Placental Transfusion between sex-discordant twins?

The aim of this study is to determine whether male microchimerism is present in patients with MRKH syndrome. This would be a sign of intrauterine cell trafficking - and possible AMH transfer- from male to female co-twin. This placental blood…

A randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study)

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…