171 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…
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…
In this study we aim to examine the effects of a low dosage of prophylactic haloperidol in patients with an expected ICU length of stay of >1 day. We use two different dosages of haloperidol in this study to compare with placebo. A dosage of…
The primary objective of this study is to demonstrate that free field word recognition scores in quiet and noise with CI *ON* are significantly better than the best aided pre-implant scores in the ear to be implanted (contralateral ear plugged)…
The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…
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…
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…
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…
Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…
investigate whether early treatment with ChEI delays the progression of minor VH to major VH without insight or PDP. In addition, we will measure motor control, psychotic symptoms, cognitive impairment, mood disorders, adverse events and compliance…
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…
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…