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DIY health monitoring and simulation of health in pregnant women: a pilot study

Primary Objective: To determine the feasibility of DIY studies in pregnant women to detect changes in health parameters, by:a. assessing the compliance of participants with the study protocol (number of complete total datasets as well as per…

Optimizing abiraterone (zytiga®)therapy by exploring the relation between an early biomarker-drug exposure-as a predictor for drug response in patients with mCRPC (OPTIMUM study)

Primary Objectives:*To explore whether early abiraterone exposure (AUC) is corre*lated to treatment response after 3 months and 6 months of therapy (primarily based on radiographic response (RECIST re*sponse: SD, PR, CR) and secondary on…

OPTIMIZING PERIPHERAL CIRCULATION WITH VASODILATOR THERAPY IN CRITICALLY ILL PATIENTS WITH CIRCULATORY SHOCK: A PILOT STUDY

We hypothesize that stepwise dose of intravenous infusion of nitroglycerin reverses clinical abnormalities of peripheral circulation in patients with circulatory shock and that this can lead to improvement in survival rate. In addition, we expect…

A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)

Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…

The reliability of new point-of-care instruments for breath analysis in children with asthma and cystic fibrosis (CF), and healthy controls

Research questions: Primary questions:* Are the new point-of-care instruments for the measurement of VOCs in exhaled breath feasible for use in children and adolescents aged 6 to 20 years?* Are these techniques able to differentiate between healthy…

Bandolera trial: The 'Banded' Gastric Bypass

To research in three groups whether there is a significant difference between RYGB and BRYGB patients.

Pharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients

The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…

A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer*s Disease Spectrum

The primary objective of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in subjects in the early AD spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ 54861911 (e.g., Study 54861911ALZ2002),…

Randomized-controlled clinical trial for the evaluation of the efficacy of computational simulation for the planning of vascular access surgery in hemodialysis patients

To evaluate the efficacy of computational simulation for the planning of vascular access surgery in hemodialysis patients.

Self-management in type 2 diabetes patients on insulin therapy triggered by app-messages

To investigate the effectiveness of text-messages sent via a smartphone app (app-triggers) regarding dietary habits, physical activity, prevention of hypoglycaemic events and glycaemic variability on HbA1c, body weight, diabetes self-management and…

The role of the intestinal microbiome in enteric and systemic vaccine immune responses

Primary Objective: to investigate the role of the gut microbiota in RVV immune response Secondary Objectives: To investigate the role of the gut microbiota in tetanus and pneumococcal vaccine immune responses

Economic evaluation of treatment modalities for position dependent obstructive sleep apnea patients

To evaluate the effect and cost-utility of positional therapy, comparing the SPT and MRA versus CPAP in patients with moderate positional obstructive sleep apnea.

Dutch randomized multicenter trial COmparing twO PalliativE RAdiaTION schemes for incurable head and neck cancer (COOPERATION)

to investigate the oncologic outcomes, toxicity and QoL of two commonly used palliative radiation schemes in the Netherlands

The Role of Conditioning for Pharmacotherapeutic Treatments in Rheumatoid Arthritis.

This study aims to enhance pharmacotherapeutic effects in patients with recent-onset RA by means of conditioning (via a variable reinforcement schedule).

A Phase I Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of CriPec® docetaxel in Patients with Solid Tumours.

Circulating CriPec docetaxel nanoparticles are designed to be in a higher degree than the original compound (docetaxel) to be trapped in tumor tissue due to the enhanced penetration and retention (EPR) effect. Subsequent release of docetaxel from…

DenovoDerm phase I. A phase I, open, prospective, multicentric study to evaluate the safety of autologous tissue-engineered dermal substitutes for the treatment of large deep-partial and full-thickness skin defects

To evaluate the safety of an autologous cellular collagen hydrogel-based skin graft (denovoDerm) in patients with skin defects that require definitive therapeutic coverage. DenovoDerm can be transplanted together with an STSG to cover a full…

Dexmedetomidine versus propofol in the awake implantation of a neuromodulative system.

The purpose of this study is to observe the usability of dexmedetomidine compared to the standard therapy (propofol) and to determine the overall satisfaction of the patient.

Intake and growth in late preterms

Primary Objective: To prospectively obtain the (parenteral/enteral) intake of protein, fat, carbohydrates and calories in moderately preterm infants (32-36 weeks) and obtain prospectively growth data in the first 2 years of life. Secondary Objective…

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

Study ObjectivesTo compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM Secondary Objectives:To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with…

Early detection of pressure ulcers in individuals with a complete spinal cord injury

To determine if a marked change in the concentrations of one or more of the selected biomarker is evident before PUs are visible