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Multi-center, Randomized, Open-label, Parallel-arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects with Congenital Factor VII Deficiency

- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689

Role of different phosphate binders on absorption of vitamin K, metabolism of matrix *-carboxy-glutamaat (Gla) proteïne (MGP).

This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in…

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

A single center, randomized, open-label, cross-over exploratory study to evaluate the pharmacodynamic and pharmacokinetic response to a subcutaneous administration or oral administration of furosemide in subjects presenting with chronic fluid overload

Primary Objective • To assess the effects of 80mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload. Secondary…

Mindfulness training versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD)

To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).

Op Volle Kracht: An intervention to increase emotional resilience among youth in residential treatment centers

Main: 1. To investigate whether a short term CBT-based group program is more effective in reducing symptoms of depression and anxiety than treatment as usual (TAU), among adolescents aged 10-16 within residential treatment settings in the youth…

Efficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients

The primary objective of this study is to compare the therapeutic effect on atopic dermatitis of a skin barrier repair cream (Dermalex eczema) in contrast to a standard used emollient (unguentum leniens FNA) and a dermatocorticoid (hydrocortisone)…

PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation.

The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.

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…

A Study to Evaluate the Relative Bioavailability and Effect of Food on Two Formulations of the MK-3682A Fixed-Dose Combination Tablets (MK-3682/MK-5172/MK-8742, 300 mg/ 100 mg/50 mg) in Healthy Adult Subjects.

Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…

The effects of music therapy on expressive and communicative skills in relation to change in behavioral problems for patients with Huntington's Disease

Research questions:1. Does music therapy improve the expressive and communicative skills of patients with HD due to (specific) music therapy treatment? 2. Does music therapy change problem behavior of patients with HD?

REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus* Valve System - Randomized Clinical Evaluation

The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus* Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered…

ADHD: Medication or Meditation?

The comparison of the effects (and cost effectiveness) of mindfulness training for the child + Mindful Parenting for the parents versus medication (Methylphenidate) in a randomized controlled trial (RCT) in children with ADHD, aged 9-18.

Analgesic efficacy of saphenous nerve blockade for outpatient knee anterior cruciate ligament surgery

The general aim of this present study is to investigate whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of…

A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

Primary objective:To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central radiologists* review in subjects with PD-L1 strong, 1L metastatic NSCLC treated with MK-3475 compared to standard of care (SOC…

A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer

Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…

10-day decitabine versus conventional chemotherapy (*3+7*) followed by allografting in AML patients >= 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group

The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.

De-ESCALaTE HPV: Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinoma.

Primary objective: To compare the severe (acute and late) toxicity (Grade 3-5), as assessed by CTCAE Version 4, caused by cetuximab and RT to that caused by cisplatin and RT in patients with HPV+OPSCC.Secondary objectives:- Compare overall number of…

Fixed versus variable dosing strategy of prothrombin complex concentrate for bleeding complications of vitamin K antagonists

To test whether the clinical outcome of lower fixed dose of PCC is superior to higher variable dose of PCC, for VKA related bleeding in a randomized setting. Secondary objectives include the comparison of INR after administration of PCC, time to…

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…