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Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A

Primary Objective• To compare the annualised total bleeding rate of individually tailored prophylaxis with the historical bleeding rate observed in patients having received on-demand treatment with Human-cl rhFVIII from study GENA-01Secondary…

NETest in patients with resected pancreatic neuroendocrine tumor

The aim of this study is to investigate if the NETest is useful in the follow up program after curative resection in patients with pNET. Therefore the diagnostic accuracy of the NETest in resected patients with pNET will be analysed. The study is…

A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), Or Post-Essential Thrombocythemia MF (post-ET MF)

To determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by * 1 grade in intermediate-1, intermediate-2, and high risk subjects with PMF, post-PV MF, or post ET-MF who are anemic or thrombocytopenic and…

Identification of (bio)markers in Dementia with Lewy Bodies.

To identify novel diagnostic and prognostic (bio)markers of Dementia with Lewy Bodies.

The effects of bright light therapy for depression in adults with intellectual disability.

The purpose of the present study is to investigate the effects of light therapy (with two different light boxes) on depression in people with intellectual disability (IQ *70 ) compared to standard care (care as usual).

An open label study in two parallel groups, each receiving in a randomized, two period, cross-over design two single doses of Risperdal® Consta®, to explore the comparative bioavailability of two different batches of Risperdal® Consta® and the intra subject variability of one Risperdal® Consta® batch after intramuscular administration in healthy volunteers

Primary objectives:* To explore the comparative bioavailability between 12.5 mg of Risperdal® Consta® prepared from a 25 mg dose strength of Risperdal® Consta® EU-sourced, and 12.5 mg of Risperdal® Consta® prepared from a 12.5 mg dose strength…

Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma:
A multicenter randomized phase II trial *The TRENDY trial*

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

A randomized, double blind, cross-over trial to study the effects of adding bezafibrate to standard lipid lowering therapy on postprandial lipids in patients with Familial Dysbetalipoproteinemia

To evaluate the difference in the post fat load non HDL after an oral fatload between bezafibrate and placebo in patients with FD using standard lipid-lowering therapy

A Multicenter, Open-Label Study of Sebelipase Alfa in Patients with Lysosomal Acid Lipase deficiency

The primary objective of this study is to evaluate the safety of sebelipase alfa in a more broad population of subjects with LAL Deficiency than have been previously studied.The secondary objectives of this study are (1) to evaluate effects of…

An exploratory pharmacokinetic and pharmacodynamic study of beta-lactam and fluoroquinolone in ICU patients

The aim of this study is to describe the utility of beta-lactam and fluoroquinolone TDM programs in tertiary ICUs. Therefore, the main objective is to document whether empirical antibiotic dosing regimens of these antibiotics achieve defined…

Activity and heartrate monitor validation study

The primary objective of this study is to determine the accuracy of energy expenditure and resting heart rate measurement.Secondary objectives include assessment of accuracy of other measures like sleep duration, steps counting, activity recognition…

Prevention of skeletal muscle and myocardial free-fatty acid induced microvascular dysfunction in skeletal muscle and myocardium by exercise

We hypothesize that the amount of physical activity correlates with insulin-induced microvascular recruitment during free-fatty acid infusion in skeletal muscle as well as in the heart. In this study we aim to test this hypothesis.

Physical trauma patients with symptoms of an acute stress disorder: an observational study

Primary objective: to examine the natural course of ASD symptoms Second objective: to determine the effects of ASD symptoms on the development of PTSD and patients* psychological distress (i.e., anxiety and depressive symptoms), coping, and QOL…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…

Laparoscopic advanced Imaging Techniques in Endometriosis therapy: the LITE study. A pilot trial.

To determine which advanced image enhanced modality is the most feasible for the detection of endometriosis lesions, with respect to the specificity and sensitivity of the investigated modalities. To determine which imaging modality reveals more…

99mTc-mebrofenin Hepatobiliary Scintigraphy (99mTc-HBS) liver function stress test - liver reserve capacity and age dependant changes in liver function - CHOCOLATE STRESS TEST

In this study we will explore changes in the hepatic function after stimulation of hepatic cells with an oral food challenge, the **hepatocyte reserve capacity**. Moreover, we will explore potential differences in the hepatocyte reserve capacity…

Investigation of the signature of recurrence and radiation effects after External-Beam Radiotherapy of prostate cancer on multi-parametric MRI

Primary objective: • Investigate the signature of recurrent prostate cancer and of radiation effects after external-beam radiotherapy on multi-parametric MRISecondary objective: • Identify imaging features that are characteristic of recurrent…

The sensitivity of scar-biopsies for residual colorectal adenocarcinoma after endoscopic resection with uncertain radicality.

To evaluate the sensitivity of second-look endoscopic biopsies from the polypectomy site for residual adenocarcinoma in the surgical resection specimen.To register patients in whom exclusion criteria exist, in order to prospectively evaluate the…

An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations

Primary• To evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-…

Biological variation of cardiac biomarkers in aortic valve stenosis

To study the biological variation of cardiac biomarkers (e.g. cardiac troponin T and I, NT-pro-BNP, ST-2, Galectin-3) in clinically stable moderate aortic valve stenosis.