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The role of dopamine and noradrenaline in probability and reward value processing.

This study aims to clarify whether the brain dopamine and noradrenaline system underlie the electrocortical responses (event-related potentials) that are sensitive to cues signalling reward and probability, the P200 and P300.

Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control.

1). To compare temporal fluctuations of lung function and inflammatory biomarkers in blood, nasal lavage, exhaled air and urine between patients with asthma and controls.2). To investigate the change in variations of these biomarkers upon…

Predicting the Outcome of a Demyelinating event

PROUD is a multicentre prospective study, using clinical factors in combination with additional tests with the aim to clarify more about the aetiology and pathogenesis of MS.

Neurocognitive effects of low-grade glioma resection in eloquent areas

1) Evaluating the effect and recovery of glioma surgery in eloquent areas on cognitive functioning.2) Examining the effec tof glioma surgery in eloquent areas on quality of life.3) Examining the effect of gliomas in eloquent areas on the…

The effect of an assist-as-needed algorithm applied by a robotic gait trainer on walking in stroke and SCI patients

Primary objectives:1. What is the effect of walking on a treadmill compared to walking in a patient-in-charge mode on kinematics in healthy subjects?2. What is the effect of walking on a treadmill compared to walking in a patient-in-charge mode on…

A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Characterization and localization of microstructural changes in brain tissue in Neuropsychiatric Systemic Lupus Erythematosus (NPSLE)

• To increase the sensitivity of the current MRI methods for detecting the changes caused by NPSLE through the scans made on the 7 Tesla scanner, since the higher field strength will lead to a higher signal to noise ratio and higher resolution. • To…

Spinal Muscular Atrophy, SMN protein and Genetics; A population based study on spinal muscular atrophy in the Netherlands to explore the prevalence of SMA type 1-4 and their severity in the Netherlands by registrating all patients in a so called SMA-database, to elucidate the genetic factors determining disease severity and to determine the value of SMN protein concentrations as a surrogate marker for clinical trials.

The main objective of this prospective population-based study of patients with proximal SMA in the Netherlands is to register SMA patients in the Netherlands in a socalled SMA-database to study prevalence and severity of SMA types 1-4, to perform…

Stress and childhood epilepsy

The overall aim of this project is to elucidate the interaction between stress and epileptic seizures in childhood epilepsy. The specific aim of this study is to compare the possible differences in stress hormone regulation, hippocampal function and…

Treatment of Central Sleep Apnea Syndrome with low-pressure nasal continuous positive airway pressure and rebreathing.

Primary objective:To show that addition of dead space to low-pressure nCPAP (which is usually not effective but can be relatively well tolerated) makes the therapy effective and diminishes the apnea hypopnea index with >10/hour in patients…

Ammendment of protocol: Intravenous iron treatment in iron deficient patients with idiopathic pulmonary arterial hypertension. Title amendment: Skeletal muscle strength in healthy persons and patients with pulmonary hypertension

To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls

A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease

We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…

A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of buspirone after a single oral administration of Lybridos in healthy female subjects

Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…

A randomized, cross-over, dose-response trial of tyrosine and its effect on working memory in healthy elderly and young people

The primary objective is to choose the dose (100, 150 or 200 mg/kg body weight) of tyrosine that shows the highest increase in plasma tyrosine concentration, based on comparison of the dose-response curves, in elderly. These dose-response curves…

Cardiac disease in Ankylosing Spondylitis

Primary objective: To investigate left ventricular diastolic function in AS-patients compared with osteoarthritis patients. Secondary objectives: To assess the prevalence of valvular heart diseases and conduction disturbances. To assess left…

*IBDome; Identification of rare variants in candidate genes and regulatory elements in familiar and sporadic early-onset IBD (inflammatory bowel disease) patients*

Primary Objective: Identification of rare variants in candidate genes and regulatory elements in pediatric IBD patients. Secondary Objective(s): To determine the functional consequences of identified genetic variants in IBD, we will correlate…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

Recovery and survival of platelet concentrates in plasma and in 3 additive solutions

The objectives of this study is to determine the recovery and survival of platelet concentrates; in the first phase, a comparison will be made for platelet concentrates in plasma stored for 2-3 days versus those stored for 6-7 days; in the second…

A prospective single-centre open label study on the efficacy and safety of 4 weekly pasireotide LAR administration in combination with or without weekly pegvisomant in previously controlled acromegaly subjects with combined treatment of long-acting somatostatin analogs and weekly pegvisomant.

The primary study objective is to assess the proportion of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment.Secondary study objectives are assessment of the…