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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…

The effect of Ivacaftor in CF patients with a class III mutation

Primary objective is to objectively investigate the therapeutic potential of Ivacaftor in Dutch CF patients carrying a mutation associated with residual CFTR function. A secondary objective is to evaluate the correlations between individual…

A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…

Reproducibility of insulin injected by needle-free jet-injection for glycaemic management in healthy volunteers

1. To compare the pharmacologic reproducibility of the rapid-acting insulin analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of…

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Study 1:1) To test the hypothesis that Liraglutide improves cardiovascular function in DM2 patients and whether the improvement is associated with redistribution of ectopic fat stores. 2) To test the hypothesis that Liraglutide activates BAT in DM2…

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…

Patient Reported Outcomes in the CAstration-resistant Prostate cancer RegIstry

The objectives are to determine generic, cancer-generic and prostate cancer-specific HRQOL and costs outside the hospital in CRPC patients during treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone and enzalutamide) in…

Prove ART (Abluminal Reservoir Technology) clinical benefIt in *all comers* patients.

Evaluate clinical performances of Cre8 in *all comer* population

Bandolera trial: The 'Banded' Gastric Bypass

To research in three groups whether there is a significant difference between RYGB and BRYGB patients.

A multicenter, international, randomized, parallel group, double-blind, placebo-controlled, cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA

The primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided 95% confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy…

The effects of hyperoxia on organ dysfunction and outcome in critically ill patients with SIRS

1. To study the short- and long-term effect of different target PaO2's on circulatory status, organ dysfunction and outcome.2. To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the…

BIOTRONIK- *A Prospective, Randomized, Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Stent in the Treatment Of Subjects With up to two de novo Coronary Artery Lesions* - IV

To evaluate the safety and effectiveness of Orsiro for the treatment of subjects with up to 2 de novo atherosclerotic coronary artery lesions.

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.

Post market study to evaluate safety and effectiveness of the InnFocus MicroShunt® (MIDI Arrow) in patients with primary open angle glaucoma

The purpose of this study is to collect additional safety and effectiveness of the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma that are inadequately controlled on maximum tolerated medical therapy with…

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…

Intravenous immunoglobulin (IVIg) overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP)

The primary objective is to determine whether subjects with CIDP are overtreated with maintenance IVIg treatment and to reduce overtreatment-associated subjects* burden and health care costs.

Personalizing enzalutamide (Xtandi®) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microRNAs, tumor related mRNAs and treatment response in patients with mCRPC (ILUMINATE)

Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…