484 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 aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…
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…
The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…
compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.
This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion, insulin bolus regimen and…
Primary: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with Combodart, compared to placebo. Secondary: changes in sexual function during 1st 9 months of the study,…
Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…
Optimization of safety of risk stratification for outpatient treatment in pulmonary embolism, through randomization between Hestia approach with or without NT-proBNP measurement.
Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related health status…
The primary objective of this study is to determine the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic pain one year after cardiac surgery. The secondary objectives are to…
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…
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…
Effect on bone mineral density.
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…
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…
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…