106 results
Primary Objective• To assess the safety and tolerability of long-term tofacitinib therapy in subjects with UC.Secondary Objectives• To evaluate the efficacy of long term tofacitinib therapy in subjects with UC.• To evaluate the effect of long term…
Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.
Primary objectiveThe primary objective of this study is to assess the feasibility and safety of omitting prophylactic postoperative drainage after pancreatic surgery. This study was designed in order to gather conclusive information regarding the…
The goal of this investigation is to show that Hemospray is effective in achieving initial hemostasis rates equivalent to standard of care treatment and a decreased rate of further bleed when compared to standard of care up to 72 hours after…
To identify circulating mediators that are released after surgery and which are responsible for macrophage activation.
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in the following laparoscopic procedures: hernia repair, cholecystectomy, right colectomy, Nissen fundoplication and sigmoidresection. The AutoLap…
To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…
The aim of this study is to investigate the safety and efficacy of biodegradable self-expandable stents in patients with a benign fibrotic pancreatic duct stricture due to chronic pancreatitis.
To identify genetic risk factors associated with GERD.
The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.Secundary objectives are determination of PK data and predictors of response to IFX in pediatric CD.
1. What is the complication rate of the initial antibiotic treatment strategy for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Main objective: to determine the effect, defined as the percentage of patients that show a clinical relevant improvement on the severity of complaints of nocturnal sialorrhea, of oral glycopyrroniumbromide in comparison with placebo in psychiatric…
To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with *standard of care* IFX…
To compare the efficacy of a fixed dose of SC methylnaltrexone to induce laxation in patients receiving palliative care with constipation due to either fentanyl, oxycodone or morphine sulphate (opioids with different mechanisms of action). Secondary…
Trial hypothesisAdding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the…
To evaluate the hypothesis that patients with an abnormal pancreatic duct (PD) in which the transluminal stents are left in situ have a lower pancreatic fluid collection recurrence rate after endoscopic transluminal drainage in comparison to…
Primary:- To identify causal genetic variants and proteomes involved in achalasia and to study their relevanceSecundary:- To build-up a large scale harmonized biobank of achalasia patients, based on combining existing and new data from the European…
To determine the difference in EGG patterns in a fasting state and after a test meal between healthy controls and patients suffering from splanchnic ischemia (both single and multiple vessel stenosis). We hypothesize that patients with splanchnic…
Implementation of a biobank infrastructure to facilitate development and improvement of screening markers for colorectal neoplasia. New biomarkers will be compared to state of the art tests, e.g. currently FIT.
Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…