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The adenosine receptor; a new pharmacological tool in the treatment of sepsis.

Does antagonism of the adenosine receptor by caffeine lead to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissuedamage?Does the C34T-polymorphism of the enzyme AMP-deaminase lead to a decreased inflammatory…

The Effect of Exercise Training in Adult Patients with a Systemic Right Ventricle

The aim of the present study is to evaluate the effect of exercise training on exercise capacity, serum NT-proBNP levels and quality of life in adult patients with a systemic right ventricle.

Utrecht Spina Bifida And Graded Exercise (USAGE) Study part 2: Does training in ambulatory children with SB increase levels of physical fitness, energy cost of locomotion and daily physical activity?

Primary objective:To evaluate the effects of a training program on physical fitness, energy cost of locomotion and daily physical activity in ambulatory children and adolescents with Spina Bifida Secondary objectives: (1) evaluate physical fitness (…

Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: a multicenter study

The proposed study will focus on newly diagnosed breast cancer patients who, prior to receiving treatment, are identified on the basis of age or family history of breast or ovarian cancer as having at least a 10% risk of carrying a mutation in the…

Leiden's IVIg trial in Rhesus disease of the Neonate

AimTo determine whether the prophylactic use of IVIg reduces the need for ET in neonates with Rh-D hemolytic disease.

NOSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs

To compare the clinical outcome after a first episode of VTE in patients with well-defined thrombophilia who have been identified and treated for a longer duration with anticoagulants with patients with VTE who have not been routinely tested.

High dose statins in post-coarctectomy patients.

To reduce atherosclerotic progression in post-coarctectomy patients.

A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study of Colesevelam as Add-on Therapy in Patients with Familial Hypercholesterolaemia.

This study is being conducted in patients with familial hypercholesterolaemia (FH) to:1. Assess the efficacy of colesevelam added to a maximal tolerated and stable regimen of statin and ezetimibe in further decreasing the low-density lipoprotein (…

Pharmacological and genetic imaging of executive function deficits

With this study we want to identify the common aetiology and neurobiology of EFD, by employing pharmacological and genetic imaging in three neuropsychiatric disorders. We want to identify an underlying functional and structural model for EFD,…

International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig shunt)

Primary:To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary…

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy

The primary objective of this study is to:* Evaluate the effect of GS-6615 on exercise capacity, as measured by Peak VO2 achieved during cardiopulmonary exercise testing (CPET), in subjects with symptomatic hypertrophiccardiomyopathy (HCM).The…

A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.

To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate
the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

To evaluate the efficacy of VX-661 in combination with ivacaftor through 24 weeks of treatment in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of VX-661 on the QT/QTc Interval in Healthy Subjects

The purpose of Part A is to investigate how safe the study compound is and how well the study compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed into and eliminated from the body (this is…

A 2-part, randomized, double-blind, placebo-controlled, sequential group, dose-escalation study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of GLPG2737 in healthy male sub.

The purpose of the study is to investigate how safe GLPG2737 is and how well GLPG2737 is tolerated. It will also be investigated how quickly and to what extent GLPG2737 is absorbed into, distributed in, and eliminated from the body (this is called…

Tactile stimulation to improve spontaneous breathing in neonatal resuscitation

The objective of this study is to compare the direct effect of repetitive tactile stimulation versus standard stimulation on the respiratory effort of preterm infants during stabilisation at birth. The most ideal comparison would be to compare…

Multi-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508
homozygous Cystic Fibrosis patients

The aim of this trial is to test in a first clinical study the above mentioned hypothesis that BAY63-2521 can at least partially correct deltaF508-CFTR function. Therefore, we plan to include patients with Cystic Fibrosis, who are homozygous for the…

High versus low initial oxygen to improve the breathing effort of preterm infants at birth

The objective of this study is to compare the direct effect of the administration of an initial FiO2 of 1.0 versus 0.3 on respiratory effort during stabilisation of preterm infants in the first 5 minutes after birth. After evaluation of the initial…

Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.

The aim of the study is to test the hypothesis that intermittent intravenous paracetamol administration in children after cardiac surgery will result in a reduction of at least 30% of the cumulative morphine requirement.

The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL)

The objective of this proposal is to determine the effect of Lamotrigine on cognitive functioning and neurophysiology in adolescents with NF1.