155 results
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…
To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
The purpose of this study is to determine whether the efficacy and safetyof QVA149 (110/50 *g o.d.) and triple treatment with tiotropium (18 *go.d.) + salmeterol/fluticasone propionate FDC (50/500 *g b.i.d.) arecomparable in patients with moderate…
Urolastic® versus Bulkamid® in treatment of female stress incontinence: randomized controlled trial.
Subjective cure of urinary stress incontinence at 12 months after intervention and comparison of a new bulking agent Urolastic ® with Bulkamid® in the treatment of stress urinary incontinence. Our hypothesis: based on our study and literature…
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…
Objective of the INFINITE 2 MRI Study is to collect data on the ImageReady* MR Conditional Pacing System in subjects already implanted with the system according to standard medical guidelines for PM implantation and meets the labeled MRI Conditions…
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…
To research in three groups whether there is a significant difference between RYGB and BRYGB patients.
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…
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…
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,…
Primary Objective: To investigate the behavioral effects of controlled discontinuation as well as the feasibility of discontinuing currently ongoing treatment with risperidone in children and adolescents with behavioral problems who have used…
The goal of this study is to prove whether kidney transplant recipients can reduce their risk of cardiovascular disease bij converting to Nulojix.
Primary objective: To compare the anti-hypertensive response to dietary salt restriction with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in patients with CKD stages 3 or 4. Secondary objectives: * To analyze the…
To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
The primary study objective is to determine whether Febuxostat daily 80-120 mg is better than Allopurinol daily 100-600 mg in inducing positive changes in Pulse Wave Velocity (PWV) after 36 weeks of treatment.
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