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A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut*s Efficacy and Safety for treating peanut allergy in children and adults.

· To determine the efficacy of several doses of Viaskin® Peanut to significantlydesensitize peanut-allergic subjects to peanut after 12 months of EPIT treatment .· To evaluate the safety of a long-term EPIT with Viaskin® Peanut.

An Investigator Initiated, Controlled, Prospective, Non-Inferiority, Parallel-Group, randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the Pulmonary Veins with a Cryoballoon Catheter Versus a Radiofrequency Ablation with a ThermoCool Catheter in Patients with Paroxysmal Atrial Fibrillation

Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation (AF).

Physical fitness levels of wheelchair-bound children and adolescents with osteogenesis imperfecta: a feasibility and reliability study

To investigate whether children with OI who use a wheelchair (for long distances) can reliably perform a valid shuttle ride test in order to assess the levels of health-related fitness in this group.

Optimization of exercise therapy in type 2 diabetes mellitus

1. Measurement of the 24-hour glycemic profile in response to acute submaximal hypoxic and hyperoxic exercise in order to determine its effectiveness and select the most efficient method in reducing post-exercise hyperglycemia prevalence in…

Assessment of inflammatory response of bronchial cells to gastric juice from hospitalized infants on and off proton pump inhibitor (PPI) therapy, PICU admitted children and long term users (0-18 years) of PPIs and controls off PPI

Quantify inflammatory response (through IL-8 production) of bronchial (both commercial available cells and cultivated brushed infant cells) when exposing these to gastric juice from: hospitalized Infants, before and during PPI treatment and age…

Effectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT

ObjectiveTo investigate the effectiveness of autonomygroups for (Dutch) patients with anxiety disorders.Research questions(1) *Do patients with anxiety disorders show a significant increase of autonomy after the autonomygroup?*(2) *Do patients with…

A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.

Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…

Innovation in health care for patients with Coeliac Disease: a
multidisciplinary ICT self management system.

Evaluation of a multidisciplinary ICT SMS for children with CD.

Skin sparing mastectomy with implant reconstruction: clinical outcomes and cost effectiveness of reconstruction in one stage with the use of a collagen matrix. A randomized clinical trial.

A novel one-stage procedure where definitive implants are combined with a collagen matrix is compared to the traditional two-staged procedure where a tissue expander is placed before an implant. Our hypotheses are the following:The use of a collagen…

Cost-effectiveness of minimal interventional procedures for patients with chronic low back pain

The main objective of this project is to evaluate the effectiveness and cost-effectiveness of minimal interventional procedures as an add-on to a multidisciplinary pain program for patients with chronic mechanical low back pain who are referred to a…

Bioequivalence study in healthy volunteers of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase I (VALID I)

In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…

Molecular profiling of Parkinson's disease

The main objective of this study is to develop a method to identify susceptible pathways of redox metabolism and bioenergetics in peripheral blood cells and induced pluripotent stem cells from patients with PD and DLB.

Rosuvastatin use to improve the coagulation profile in patients with venous thrombosis: The STAtins Reduce Thrombophilia (START) Study

To understand why statins are able to decrease the risk of developing venous thrombosis, by analyzing whether statins can influence pathways that inhibit coagulation.

Adipose tissue in overweight individuals with and without the metabolic syndrome; differences in free fatty acid profile in Fasting and Fed state using 1H-MR-spectroscopy.

1. Evaluation of differences in free fatty acid (FFA) profiles of several adipose tissue depots, expressed as FFA ratios, between metabolically healthy obese subjects and metabolically unhealthy obese subjects (e.g. subjects with metabolic syndrome…

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

The primary objective of this study is to investigate equivalence of weight gain from randomisation until the age of 17 weeks in infants receiving the test product compared to infants receiving the control product. Secondary objectives of this study…

Evaluation of Balloon-based Focal Cryoablation of Human Esophageal Epithelium

This is a feasibility study of the Balloon-based Focal Cryoablation System to assess safety and performance in patients with a Barretts esophagus

The diagnostic value of additional research in giant cell arteritis

This study aims to investigate the sensitivity and specificity of the history and physical examination for the diagnosis of giant cell arteritis, compared with the superficial temporal artery biopsy, and get more insight into the positive and…

An international prospective, double-blind, placebo-controlled
phase III RCT in which patients with moderate to severe psoriasis
vulgaris are treated with s.c. methotrexate using an optimized
treatment schedule.

Primary objective: to evaluate the efficacy of subcutaneous application of methotrexate in patients with moderate to severe Psoriasis compared to Placebo as assessed by achieving the primary endpoint PASI 75 after a 16 week treatment phase.…

Open label, Single Ascending Dose, Cross-over Study to Assess the Pharmacokinetics of Circadin® (Prolonged-Release Melatonin) Mini tablets in Children with Neurodevelopmental disorders and Sleep Disturbances.

- To establish the 24-hour baseline profile of endogenous saliva melatonin concentrations and urine 6-SMT excretion in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances . - To establish the…