18 results
Primary objective: To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea Secondary objectives: To study the effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity), To study the pharmacogenetics…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
Objectives:The objective of the trial is to evaluate efficacy and safety of two different doses of Nefecon® in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure…
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
Primary objective- Survival without BPD at 36 weeks gestational age (GA)Secondary objectives- Neurodevelopment at a corrected age of 18-22 months- Adverse treatment effects- Mortality at 36 weeks gestational age- BPD incidence at 36 weeks…
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
Primary:* To assess the efficacy of 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).Secondary:* To study safety and tolerability…
The objective of this feasibility study is to evaluate the clinical accuracy of an in*house developed electromagnetic (EM) navigation system in determining adequate resection margins during surgery for malignant oral cavity tumors and specifically…
To study the effect size of FMT after a 3 weeks course of budesonide as induction therapy in patients with active ulcerative colitis despite previous therapy. The purpose of the pre-treatment is to reduce active inflammation prior to donor feces…
Determine the feasibility, safety and efficacy of electromagnetic-based image guided navigation system during soft tissue (robot assisted) laparoscopic surgery.
The Budesonide oral suspension is a new drug formulation especially developed for the treatment of eosinophile esophagitis in children and adolescents. The purpose of this clinical study is to investigate whether Budesonide oral suspension is…
Primary:* To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE).Secondary…
* To demonstrate efficacy of budesonide (9 mg budesonide/d) vs. placebo for induction of remission in active incomplete microscopic colitis after 8 weeks of treatment* To study the maintenance of remission after end of treatment* To study safety and…
Primary Objective:To measure distances between the pointer tip held on surgical clips placed on the liver surface and the closest tumor border using navigation, and compare it to the actual distance measured in intraoperative XperCT. Secondary…
The primary objective of this study is to assess the feasibility of ultrasound-based navigation for assistance during open hepatic resection. Secondary objectives are 1) to evaluate the ease of use and support for decisiveness during surgery, 2) to…
The aim of this study is to develop and evaluate a new ultrasound-based navigation system for guidance of resection and ablation of liver lesions during liver surgery. The feasibility and accuracy of this in-house developed navigation system is…
The objective of the study is to investigate whether the use of budesonde orodispergible tablets after ESD can prevent the devolpment of oesophageal strictures
Primary Objective To demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).Secondary Objectives1. To determine predictive factors for successful ICS withdrawal.2.…