225 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 the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…
the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…
The objective of the LEOPARD-2 trial is to assess the safety of MIPD versus OPD and after that to assess the time to functional recovery of MIPD versus OPD for symptomatic benign, premalignant or malignant peri-ampullary disease.
The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day
Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.
The primary objective is to study the effect of paediatric pelvic physiotherapy in addition to conventional therapy on the number of patients with treatment success in children aged 4-17 years presenting in primary care with functional constipation…
We study whether addition of a radiation boost to standard chemoradiation in patients with locally advanced rectal cancer increases the complete response rate defined as pathological complete response in those who undergo surgery, or 2-years local…
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
Primary Objective* The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary Objective* The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659…
To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue
Currently, there is no guideline for the treatment of perianal Crohn's fistulas. the aim of this study, in which surgical strategies (seton drainage and surgical closure with advancement plasty/LIFT) will be compared to medical treatment. We…
The primary objective of the study is to gain insight in the short term and long term effects of the EFCT-ODA therapy on 1) dyadic coping abilities in the relationship and 2) relational satisfaction. Moreover, the process aspects of the ODA will be…
Objective: the use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of high peri-anal fistula*s.
Primary objective: To evaluate the effects of eHealth therapy and usual care in IBD patients with arthralgia and to compare the effects of eHealth interventions plus usual care with just usual care in IBD patients with arthralgia.
The purpose of this study is to evaluate the efficacy of two antibiotics ( neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the intestine.
Primary:* To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.Secondary:* To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.* To evaluate the effect of…
The main objective is to compare the efficacy and safety of esophageal dilation with the balloon the Savary bougie dilator according to the rule-of-3 to rule-of > 3 strategy during 6 months in patients with a severe benign esophageal…
The aim of the study is to investigate and understand the performance of three new baseplates consisting of a neutralizing layer and one of three adhesives (two new adhesives and one known adhesive) in terms of protecting the skin from damage…