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2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of *36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

To explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.

Implicit and explicit home-based training programs for young children with cerebral palsy: process evaluation and effectiveness on bimanual performance and parental stress

To assess fidelity (quality), dose delivered (completeness), dose received (exposure and satisfaction), recruitment and context of two newly developed upper limb home-based training programs, i.e. one based on implicit strategies and one based on…

Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.

The effects of anaesthesia on neurodevelopmental outcome and apnoe in infants: the GAS study.

The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes. Secondary objectives are to…

Follow-up at school age after early intervention in infancy

To evaluate the long-term effects of early intervention in high-risk infants on the basis of the VIP-project.

An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent (NEMO).

The aim of the trial is to obtain data on the optimal dose, feasibility and pharmacokinetics of bumetanide when given as an add-on treatment for seizures in full term babies with hypoxic ischemic encephalopathy (HIE). Bumetanide will be given in a…

Neuromodulation with repetitive Transcranial Magnetic Stimulation of the motor cortex in first ever stroke patients

Probleemstelling: Er is geen duidelijkheid of rTMS, toegepast binnen het reguliere revalidatieprogramma na een beroerte, leidt tot een extra verbetering in motorische herstel volgens de klinimetrie zoals gehanteerd binnen de in Nederland gebruikte…

Wii-habilitation of Upper Extremity Function in Children with Cerebral Palsy, an explorative study

The primary objective of this explorative study is to evaluate the training effect on the upper extremity function of the (most) affected arm in unilateral activity, in children with unilateral and bilateral spastic Cerebral Palsy using the WiiTM…

Optimizing orthotic management in children with cerebral palsy to improve mobility and participation

The primary objective of this study is to evaluate AFO efficacy in children with spastic CP using outcome measures related to ICF the components of *body functions and structures* and *activities and participation*. The secondary aim is to identify…

2-duct ligation versus botulinum toxin for severe drooling in children with cerebral palsy

The main objective of the study is to address the relative efficacy of botulinum toxin and 2-duct ligation in children with cerebral palsy, who suffer from severe drooling despite maximal conservative treatment.

Effect and working mechanisms of horseback riding therapy on motor function and daily activities of children with cerebral palsy. A feasibility study.

The primary aim of the study is to investigate the feasibility of a RCT study on effectivity and workingmechanisms of HRT in children with CP. The Doel van deze studie is ten eerste de feasiblity onderzoeken van een toekomstige RCT study over het…

Reduction of brain damage after perinatal arterial stroke (PAS) with recombinant human erythropoietine (rhEPO): "feasibility" and "safety study".

To investigate if rhEPO has a positive effect on MRI/MRA parameters compared to infants with stroke without rhEPO collected from historical data.To investigate if rhEPO (3 dosages of 1000IU/kg/day) for perinatal stroke has no negative side-effects…

Pharmacokinetics and Pharmacodynamics of Medication
in Asphyxiated Newborns During Controlled Hypothermia
PharmaCool National Multicenter Study.

This project aims to develop an evidence based effective and "safe" dosing regimen for commonly used life saving medicationsused in the treatment of asphyxiated, critically ill newborns, undergoing therapeutic hypothermia.To this aim the…

A Phase III Open-Label, Single-Group, Extension Study to
Obtain Long-Term Safety and Tolerability Data of
Idebenone in the Treatment of Friedreich*s Ataxia Patients

- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…

Effect of Botulinum Toxin A Injections and Specific Intensive Rehabilitation Therapy in Children with Hemiparetic Cerebral Palsy on Upper Limb Functions and Skills

Objective: to determine whether botulinum toxin A (btA) injections, intensive bimanual skill training, or a combination of both leads to more and better use of the affected arm in hemiparetic children in play, leisure time, school and personal care.

The effect of Botulinum toxin treatment on the activity level of patients with a spastic hemiparesis after stroke

To investigate the effect of Botulinum toxin treatment on the activity level of people with spastic hemiparese after stroke.

A multicentre, randomised, active comparator, parallel group study to compare the effect on cognition of adjunctive therapy with zonisamide versus sodium valproate.

Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved for the treatment of epilepsy. This study is intended to investigate to what extent zonisamide can affect your memory and concentration in comparison with sodium…

The effect of Targeted Training Therapy(TTT) on children with Cerebral Palsy

Objective is to study the effect of Targeted Training Therapy on balance control in children with Cerebral Palsy.

CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

This study has been transitioned to CTIS with ID 2024-513041-37-00 check the CTIS register for the current data. Primary objective of this study is to significantly reduce relevant (moderate/severe) parenchymatous brain injury on postoperative MRI…

A Global, Multicenter, Single-arm, Matched External Control Study of Intrathecal SHP611 in Subjects with Late Infantile Metachromatic Leukodystrophy

The primary objective of this study is to evaluate the effects of intrathecal (IT) administration of SHP611 (also known as TAK-611) on the time to loss of locomotion, as indicated by category 5 or higher in the Gross Motor Function Classification in…