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Focal Cortical Dysplasias and Epilepsy: Characteristics of Histopathology and 7 tesla MRI.

In this study one of the goals is to compare 7 tesla MRI with 3 tesla MRI in terms of lesion detection in epilepsy patients and depiction of specific dysplasia-related imaging characteristics. Furthermore, resected tissue will be scanned ex-vivo at…

BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB) ) * amendment to allow extended follow up of the patients

To evaluate BlueWind Medical RENOVATM System safety and performance in OAB patients for extended FU period of 36 months.

Validation of the Sustained Attention to Response Task (SART) for assessing the fitness to drive in narcolepsy and idiopathic hypersomnia patients

Primary aim is to validate the SART as a screenings instrument for driver fitness in patients with narcolepsy and idiopathic hypersomnia.

Efficacy and safety of MRI-based thrombolysis in wake-up
stroke: a randomised, double-blind, placebo-controlled trial

The ,aim of Wake-Up is to provide a new safe and effective treatment option for acute stroke patients waking up with stroke symptoms or patients with unknown symptom onset. Every year about 2milion patients suffer a stroke in the EU and up to 20% of…

Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls

The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…

Aquacel Surgical ® ' versus ' Mepilex Border Post on ® ' in patients with elective total knee prosthesis (TKP)

The primary goal of this non-inferiority study is to show that the Mepilex Border Post op does not perform worse than the Aquacel ® Surgical ® regarding replacing the wounddressing during hospitalization in patients with TKP.In other words; the…

Non invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial

Primary Objective: Visualization and quantification of tumor hypoxia with [18F] HX4 PET imagingSecondary Objectives: - Correlation of [18F] HX4 with local tumor recurrence and survival- Correlation of hypoxia imaging with blood hypoxia markers -…

Systemic sclerosis: CT-derived evaluation of interstitial lung disease and pulmonary vasculopathy for assessment of progression of disease.
Research protocol for extended volume HRCT-thorax in patients with systemic sclerosis participating in a 2 *day multidisciplinary team care program of the department of Rheumatology and Pulmonology

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Molecular studies on reduced ovarian reserve and embryo competence in BRCA1/2 mutation carriers

Investigate the association between BRCA1/2-mutations, DNA damage, apoptosis and oocyte/embryo quality in immature germinal vesicle (GV) bearing oocytes, immature metaphase 1 (MI) and unfertilized mature metaphase 2 (MII) oocytes and affected early-…

Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD

This research proposal aims to investigate the efficacy of the SMART approach with budesonide/fomoterol versus fixed dose treatment with fluticasone/salmeterol in patients with COPD.

GLIMP II study - An observational study to assess the role of diet and nutrient status and other lifestyle and risk factors in gestational diabetes

Primary :To compare diet quality and nutrient status before and during pregnancy of women who develop GDM with those who have normal blood sugar levelsSecondary:*To compare body composition before (and during) pregnancy of women who develop GDM with…

Reflection spectroscopy for the age determination of bruises in children.

The goal of this study is to develope and validate a non-invasive method for the age determination of bruises. This method is tested on adult volunteers. We expect differences between the healing proces of bruises in adults and children.To be more…

A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis

Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…

The impact of protein supplementation to maximize the skeletal muscle adaptive response to resistance type exercise training in healthy elderly men

Primary Objective: To examine how protein supplemented after exercise and before each night of sleep augments the resistance type exercise training-induced changes in quadriceps muscle size (CSA) in healthy elderly men. Secondary Objective:…

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, ParallelGroup, Multicenter Study of the Safety and Efficacy of JZP 110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA)

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.

Optical coherence tomography (OTC) in the follow-up of patients with X-linked adrenoleukodystrophy (X-ALD) and Zellweger spectrum disorders (ZSD).

Objective of this study is to determine if Optical Coherence Tomography (OCT) measurements are a reliable measure of the severity of neurological impairment in patients with X-ALD and ZSD and therefore if OCT is an acceptable "surrogate"…

Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia.

The main objective of the study is to develop an optimal and individualized asparaginase treatment protocol. The study consist of four sub-studies. The objective of the population pharmacokinetic study is to get more insight in the pharmacokinetics…

Functional magnetic resonance imaging of Parkinson*s disease patients to investigate the effects of dopamine on visual attention.

We aim to extend our recent work on fundamental mechanisms that underlie automatic influences of reward on attention to clinical populations that suffer from reduced and excessive reward-driven behaviours. That is, we will investigate whether…

A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, versus Enzalutamide alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone

To compare treatment with enzaluatmide plus BI836845 with treatment with enzalutamide only.

Multimodal treatment effects on empathic skills in youth with ADHD

The main objective is to explore the effects of mulimodal treatment upon empathic skills in forensic male adolescents with ADHD, with or without DBD. A secundair objective is to explore the effects of multimodal treatment upon antisocial behavior.