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The optimal treatment strategy for complex appendicitis in the pediatric population

Subgroup 1 (complex appendicitis without mass and/or abscess formation): LA is associated with reduced superficial site infections, shorter length of stay, less costs, less pain, and better hr-QoL, compared with OA without compromising overall…

A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial*

This study has been transitioned to CTIS with ID 2024-517846-32-00 check the CTIS register for the current data. To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the…

Immune responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects

Monitoring & evaluation of immune responses induced by COVID-19 vaccines in the general population in the Netherlands.

Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery.

This study has been transitioned to CTIS with ID 2024-514073-22-01 check the CTIS register for the current data. To investigate differences in coagulation between (Omniplasma) and FFP in paediatric cardiac patients, who are undergoing cardiac…

A feasibility study to evaluate PDE MAX, a food for special medical purposes (FSMP) for use in the dietary management of Pyridoxine Dependent Epilepsy (PDE) with regards to acceptability, tolerability, adherence and effect on metabolic control.

To evaluate product acceptability, tolerance and adherence during an 8-week intake of PDE MAX in patients with Pyridoxine Dependent Epilepsy.To evaluate the effects on metabolic control by comparing the changes from baseline after an 8-week intake…

Toddlers receiving synbiotics after antibiotics

To investigate the effect of a cows-milk-based formula supplemented with synbiotics from t=0 to t=21, t=42 and t=84 days after amoxicillin or amoxicillin/clavulanic acid treatment in toddlers aged 1, 2 and 3 years old on: - change in proportion of…

Basophil Activation Test cow's milk for replacement of the food challenge test

Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

This study has been transitioned to CTIS with ID 2023-510160-12-00 check the CTIS register for the current data. To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall…

TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide

Primary objective:• Evaluate PK parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over.Secondary objectives:• Evaluate the safety of the oral suspension of temozolomide,• Evaluate the acceptability of the…

Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and asperin, versus IVIG and asperin for prevention of coronary artery aneurysm (CAA) in Kawasaki disease (KD)

The overarching goal is to optimise the treatment of KD in children/adolescents across Europe.KD-CAAP will test the hypothesis that adding immediate adjunctive corticosteroid treatment to IVIGand aspirin will reduce CAA rates in unselected KD…

An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of prenatal and/or postnatal infusion of allogenic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with historical and untreated prospective controls.;In the Netherlands patients will not be treated. Retrospective and prospective control patients will be included

This study has been transitioned to CTIS with ID 2023-504593-38-00 check the CTIS register for the current data. The aim of this trial is to infuse multiple doses of human 1st trimester liver-derived MSC for the treatment of severe OI to determine…

Studying respiratory infections and colonisation in children using daily minimally-invasive nasal sampling

Primary: Associate acquisition of pneumococcal colonisation with levels of pre-existing polysaccharide specific memory B cells. Secondary: a) To validate the use of synthetic absorptive matrices (SAM) for detection of other (non-pneumococcal)…

A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the
efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in
addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with
chronic kidney disease and proteinuria

This study has been transitioned to CTIS with ID 2023-504884-17-00 check the CTIS register for the current data. The main goal of this study is to find out whether finerenone in combination with either an ACE inhibitor or an ARB can reduce the…

Virus interactions in the respiratory tract; a cohort study with children

To quantify the strength and direction of interactions between important respiratory virus infections in young children

Fucosylation of antibodies in multi-inflammatory syndrome in children after SARS-CoV-2 infection

To study the antibody response as a disease modifying factor in the context of COVID-19, we will compare the anti-CoV antibody composition, quality and interaction with immune receptors.

Baby breathing monitoring @home

The aim of the study is to collect video recordings which will be used retrospectively internally at Philips to test whether an algorithm can be used to measure the behavior and physiology of babies by using a camera and/or wearable. Development of…

A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of PBKR03 Administered to Pediatric Subjects with Early Infantile Krabbe Disease (Globoid Cell Leukodystrophy) (GALax-C)

This first-in-human study is planned to include both a dose ranging phase and a confirmatory phase, with the intention that all data collected throughout the study may support registration. The dose ranging phase will be conducted in cohorts of 3-4…

A non-traditional complex intervention for the treatment of paediatric sleep problems.

Assessing the feasibility of the research procedures, the burden on participants, the degree of dropout and reason, the interest in participating.What is the main treatment effect for parents / carers motivating them to participate in this study?•…

Monitor immune microenvironment and systemic immune effects in pediatric oncology

Brain tumors: Characterize and quantify changes in immune parameters during disease in patients with a CNS malignancyAML: Characterize and quantify changes in immune parameters and immunotherapeutic targets during disease in pediatric patients with…