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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…

Systematic Hospital-based Assessment of Rotterdam*s critically Ill children,
their Neurodevelopment and Growth

The main objective of this longitudinal study is to gain insight into the neurodevelopmental trajectories following neonatal critical illness, from the perinatal period to school-age compared to healthy controls. This insight may lead to the…

Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

This study has been transitioned to CTIS with ID 2024-516123-13-00 check the CTIS register for the current data. Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the…

Near-infrared fluorescence imaging using indocyanine green as an adjunct to improve standard-of-care sentinel lymph node procedure in pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities: a feasibility trial

To determine the feasibility of using ICG to optically guide the surgeon to the SLN of paediatric melanoma and sarcoma patients. The SNP is a diagnostic procedure.

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

This study has been transitioned to CTIS with ID 2024-514917-36-00 check the CTIS register for the current data. PRIMARY OBJECTIVES*Rx-induction: Comparison of the 3 year EFS rate of 2 induction regimens, GPOH and RAPID COJEC, in patients with high-…

Effectively intervening in traumatized parents and children after structural domestic violence

The goal of this study is first to test the effectiveness of a short-term, attachment-based parenting intervention (NIKA) for victimized mothers and their children after domestic violence (phase 1). Next, we will evaluate the additional…

Immunome project consortium for autoinflammatory disorders

Main Objectives: To collect clinical data and biological samples derived from blood (plasma, serum, cells and DNA) as well as urine and stool to perform multi-omic and functional biological assays. The resulting data will be integrated and analyzed…

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 open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous |(IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection

PrimaryTo characterise the single and multiple dose to steady state pharmacokinetics of IV zanamivirin hospitalised neonates and infants under 6 months of age with influenza infection.SecondaryTo evaluate the safety and tolerability of IV zanamivir…

The contribution of genetic predisposition to pediatric cancer: a study integrating extensive phenotyping and state of the art genotyping.

To evaluate the performance of a *genotype first approach* (WES-based panel analysis) in diagnostics of genetic predisposition in children with cancer or neoplasms, compared to the current *phenotype first approach* (standard of care). In particular…

FaR-RMS - An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma

This study has been transitioned to CTIS with ID 2024-510579-40-00 check the CTIS register for the current data. PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *…