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A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics,
safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric
subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic
leukemia before hematopoietic stem cell transplantation

The primary objective is to assess the treatment effect on response rate (MDS: either completeremission [CR], partial remission [PR], or marrow CR; JMML: either clinical completeremission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28…

Mindfulness training for youth with ADHD: Improving self-control and ADHD symptoms

Our primary objective is to evaluate the effectiveness of mindfulness training in improving self-control of youth with ADHD. As secondary objectives, we aim to quantify the effectiveness in reducing ADHD symptoms, reducing comorbid (e.g. ASD)…

The effectiveness of Pivotal Response Treatment in children and adolescents with autism spectrum disorder: a randomized clinical trail

Primary Objective: The main objective is to investigate the effectiveness of PRT compared to CAU in school-aged children and adolescents with ASD.The primary research question is:1) Directly after treatment and at follow-up, what is the…

RANDOMIZED PHASE 2 TRIAL COMPARING EXPERIMENTAL IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 S.C.,GM-CSF) IN RECURRENT HIGH RISK NEUROBLASTOMA PATIENTS WITH STANDARD IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 I.V., GM-CSF) IN PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED HIGH RISK NEUROBLASTOMA

Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…

A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial

Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…

A phase II open-label, randomized, multi-centre comparative study of bevacizumab-based therapy in paediatric patients with newly diagnosed supratentorial, infratentorial cerebellar, or peduncular high-grade glioma.

To evaluate the efficacy, safety, tolerability, and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant temozolomide (TMZ) and to determine whether the addition of anti-angiogenic therapy with…

Perforator based interposition flaps for sustainable release of scar contractures: a reliable, simple and versatile technique.

A randomised controlled multcenter trial is performed to evaluate the perforator-based interposition plasty in comparison to full thichness grafts for scar contracture releases.

A Phase 1/2 Combined Dose Ranging and Randomised, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilisation of Haematopoietic Stem Cells into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilisation Regimens Alone in Paediatric Patients, Aged 1 to <18 Years, with Solid Tumours Eligible for Autologous Transplants

In this study, plerixafor, the study drug, will be given in addition to GCSF to see if it works the same way in children as in adults.

Cholic acid treatment in Peroxisomal Biogenesis Disorders (Zellweger spectrum): biochemical and clinical effects.

To investigate the effect of cholic acid supplementation on the clinical and biochemical parameters of Zellweger spectrum disorder

An exploratory study of the biologic effects of nivolumab and nivolumab in combination with ipilimumab treatment in subjects with advanced melanoma (unresectable or metastatic).

Primary Objective:To investigate the pharmacodynamic activity of nivolumab, and nivolumab in combination with ipilimumab in the tumor environment and the periphery on biomarker measures such as circulating T cell subsets (activated and memory T…

Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia

To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.

The effect of nebulisation of ipratropiumbromide on oxygenation and end-expiratory lung volume in mechanically ventilated children: a pilot study

We hypothesize that nebulisation of ipratropiumbromide results in decreased production of sputum resulting in a better lung aeration (defined by an increase in EELV) and improved oxygenation (as defined by the PaO2/FiO2 ratio and the oxygenation…

An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients

The primary objective of this study is to compare the safety, overall tolerability, and virologic response of BCV vs. SoC (i.e., investigator-assigned therapy) for the treatment of AdV infection in high-risk pediatric allogeneic HCT recipients. A…

Providing optimal exposure to youth with anxiety disorders: effectiveness and working mechanisms

The goal of the study is to examine whether optimal exposure is more effective than CBT as usual in youth with anxiety disorders. The secondary objective is to investigate whether decreases in harm expectancies are predictive of treatment outcome,…

Pilot Randomized-controlled phase-IIa trial on the prevention of comorbid Depression and Obesity in Attention-deficit / Hyperactivity disorder

Primary objective: To assess the prevention of depressive symptoms by 10-weeks BLT and 10-weeks AEI vs. TAU, and to establish feasibility and effect sizes of these two kinds of interventions in combination with a m-Health app based reinforcement in…

The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Main objective is to evaluate the efficacy and safety of two (Part 1) different dosing regimen and of one dosing regimen (Part 2) of intravenous alteplase given for up to 5 days on top of standard of care (SOC) compared with SOC alone in ARDS…

A Randomized, Open-Label Phase 1b/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor.

The primary objective of the study is to evaluate the progression free survival of patients when these are treated with ramucirumab and cyclophosphamide and vinorelbine, in comparison to treatment without ramucirumab.The secondary objectives of the…

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. *…

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…

A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma - BEACON-Neuroblastoma Trial

This study has been transitioned to CTIS with ID 2024-518931-12-00 check the CTIS register for the current data. Primary:- To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide or irinotecan-temozolomide or topotecan-…