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SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

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…

Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome

Primairy Objective* To test whether 5-ASA reduces the occurrence of colonic benign or malignant neoplasia compared to placebo in Lynch syndrome (LS) patients as detected by any colonoscopy until the end of study.Secondary Objectives* To test wheter…

Comparison of adenoma miss rate and adenoma detection rates between Endocuff Vission-assisted colonoscopy and conventional colonoscopy: a multicenter randomized trial (EXCEED study)

(1) To compare adenoma miss rates (AMR) between Endocuff Vision-assisted colonoscopy (EAC) and conventionalcolonoscopy (CC)(2) To compare adenoma detection rates (ADR) between EAC and CC(3) To assess whether a proposed increased ADR and reduced AMR…

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…

POLYP DETECTION WITH THE PEERSCOPE SYSTEM*: A RANDOMIZED TANDEM COLONOSCOPY STUDY

To compare the additional diagnostic yield obtained by using the PeerScope System* extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and…

Enteral versus parenteral feeding in adult stem cell transplantation patients with chemotherapy-induced gastro-intestinal mucositis.

In this study, we will test which of two feeding strategies for adults during chemotherapy-induced mucositis is optimal with regards to maintaining an optimal body weight, nutritional status, gut mucosal barrier and treatment outcome (including…

Gastro-intestinal permeability and intense physical activity (GRINTA)

Primary Objective is to compare the effect of different exercise protocols on intestinal permeability and on plasma levels of glutamine and glutamine-derived amino acids, in healthy young men. A Secondary Objective is to assess the effect of…

Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

The primary objective of this study is to compare a semi-mechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

Pharmacokinetic study of the HCV protease inhibitor bocePRevir and the proton pump inhibitor OMeprazOle (PROMO)

Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…

The effects of ethanol on gut wall integrity as measured by I-FABP and LBP

The aim of this study is to determine the immediate effects of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by Intestinal Fatty Acid Binding Protein (I-FABP) and Lipopolysaccharide Binding Protein (LBP) These…

Gum chewing to prevent postoperative ileus after abdominal surgery; A multi-centre randomised single- blinded study.

In the Netherlands, gum chewing has not been incorporated in the standard postoperative care after intra-abdominal surgery. Therefore a multi-center RCT was set up to evaluate the influence of gum chewing on the development of ileus. Our null…

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers

The primary aim of the study is to determine the effect of orally administered AZD2516 as a reduction of the number of reflux episodes, in comparison with placebo, over a period of approximately three hours after a meal, in healthy male volunteers.

A Phase 1, open-label, randomized, 2-period crossover drug interaction study in healthy adult subjects to evaluate the effect of the Proton Pump Inhibitor Omeprazole on the pharmacokinetics of SSP-002358.

Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.

Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia: A pharmacodynamic and pharmacokinetic study

Study effectiveness and PK of rectal omeprazole compared to oral omeprazole

Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants.

Investigate the effect of acidic and neutral oligosaccharides supplemented enteral nutrition on infectious morbidity, feeding tolerance and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of acidic and…

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

To assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Comparison of Two Expandable Endoprosthesis for Benign Esophageal Disease

The primary objective of this study is to compare the stent migration rate of two metal expandable stents in patients with benign esophageal conditions.The secondary objectives are:• To compare the technical outcome.• To compare the functional…

Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy

To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy

Multicentre, controlled, randomised, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS (MOTUS study)

Primary objective: To demonstrate that mesalazine po 4g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis treated for 8…

Assessment of patients with PPI-refractory GORD: reflux monitoring with or without proton pump inhibitor?

Objective: To compare the yield of Symptom Association Probability with two approaches to investigate patients with PPI-resistant symptoms: 24-hour pH monitoring off PPI and 24-hour impedance monitoring on PPI.