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Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy.

To demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than VKA therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The substudy involving…

A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

To evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

Long term follow-up of perichondrial transplants for the repair of cartilage defects in the human knee by 7 tesla MRI

The aim of this study is to evaluate the quality of the cartilage of repaired defects 20-25 years after perichondrium transplantation (PT) or autologous chondrocyte translantation (ACT). Secondary objectives are to review the functionality and pain…

*Unravelling the effectiveness of a behaviour change intervention to enhance physical activity in nurse-led cardiovascular risk management: study protocol of a clustered-randomized controlled trial in primary care*

The main objective of this study is to evaluate the effectiveness of the Activate intervention in adult patients at risk for cardiovascular disease (CVD) in primary care. Secondary aims are to identify which patient-related characteristics modify…

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)

1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in CRPC patients. 2. To evaluate how these 2 imaging modalities perform compared to traditional…

Diabetes Bootcamp; Sport intervention in patients with diabetes type 2 and the association with the gut microbiota.

Primary Objective: To investigate whether exercise (Diabetes Bootcamp) induces a change in intestinal faecal microbiota (rise of butyrate-producing intestinal microbiota) related to improved glycaemic control (peripheral and hepatic insulin…

Phenotype prediction in patients with X-linked adrenoleukodystrophy: a prospective study.

The primary objective is to study if quantitative (3- and 7-Tesla) MRI protocols (MRI perfusion, diffusion tensor imaging (DTI), and chemical shift imaging (CSI)) are able to detect phenotype conversion earlier than conventional MRI. Results will be…

Influence of menarche and menstrual cycle on QTc interval in girls with genotype positive LQT1 and LQT2

Evaluate the effect of menarche and menstrual cycle on the QTc interval among girls with genetically confirmed mutations causing LQTS type 1 (LQT1) and type 2 (LQT2).

The Influence of the Pre-operative Nociceptive Profile on the Development of Chronic Pain after Inguinal Hernia Repair Surgery

In the current study we aim to pre-operatively test the effectiveness of the endogenous pain modulatory system. We hypothesize that patients with a pre-operative anti-nociceptive profile will have a lower risk to develop chronic pain after surgery…

What is the potential diagnostic value of distention and intima-media thickness measurement for the early detection of endofibrosis and is there a link between the development of endofibrosis an the coagulation activation potential of the blood?

1. To investigate a possible increase intimal-media thickness (IMT) is found of the iliacal artery in endofibrosis2. To investigate a possible altered distention is found of the iliacal artery in endofibrosis3. To compare IMT and distention…

A multicenter, open-label (Part A) followed by a randomized, double-blind, parallel-group, placebo controlled study (Part B) to evaluate maintenance of remission in subjects with active axial spondyloarthritis (axSpA) receiving either Certolizumab pegol 200mg Q2W or 200mg Q4W as compared to placebo

The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…

A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment

Primary objectives: Evaluation of the efficacy of imiquimod 5% cream compared to treatment with Large Loop excision of the transformation zone (LLETZ) for recurrent/residual CIN.Secondary objectives: evaluation of the effect of treatments on HPV DNA…

Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with PD-L1- positieve (equal or greater than 25%) NSCLC.To assess the efficacy of MEDI4736 therapy compared to SoC in terms of…

A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS)

Protocol version Amendment 1, 31-Jul-2015, paragraph 2.1, page 28:Primary objective:The primary objective is to assess the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.Secondary objectives:* Evaluation of…

A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 diabetes mellitus (EASE-2)

The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 10 in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy. Empagliflozin is…

Efficacy of revision of mesh surgery in patients with complications after treatment with vaginal synthetic mesh.

To evaluate the subjective and objective cure after surgical re-intervention due to mesh complications in our clinical setting in order to optimize therapy.

The bilious bowel: the relation between bile and bowel in development of biliary atresia and liver fibrosis. An explorative study

To investigate the origin of BA we will assess which TLR(s) is/are activated. To test the hypothesis that during development of BA and associated liver fibrosis there is a *leaky gut* and/or a change in microbiome we will use human material to…

Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.

Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…

Clinical implementation of advanced MRI techniques for localization and monitoring of sensorimotor and cognitive functions in patients with brain tumors

This study is aimed at two objectives: Objective 1: Development of new clinical fMRI protocols, based on existing cognitive tasks, that provide robust and reliable activation patterns, as well as performance measures that correlate woth…