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A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

The primary objective of this study is to evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD) who participated in and successfully completed Study M14-115.The…

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a
Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis

OBJECTIVES AND HYPOTHESIS Primary ObjectiveThe primary objective is to evaluate the accuracy of the length-109 probe set panel in predicting mucosal healing (ie, improvement in the endoscopic appearance of the mucosa) at Week 6, as measured by the…

The influence of omeprazole and pantoprazole on the platelet reactivity and inhibition of platelet aggregration of clopidogrel.

To study the influence of omeprazole and pantoprazole on the platelet reactivity index and the inhibition of platelet aggregation by clopidogrel.

Functional abdominal pain (FAP) within the context of internalizing disorders in childhood; A randomized controlled cognitive-behavioural family intervention.

We hypothesize that cognitive behavioural family intervention will be more effective compared to standard treatment in regard to the perception of FAP and resolution of co morbid internalizing psychopathology.

Esophagal evaluation after cryo-ablation of AF

The objective of the study is to evaluate whether esophagal lesions are created by cryo-ballon technique for AF ablation, and to compare this with a group of patients undergoing radiofrequency catheter ablation of AF.

FEASIBILITY OF SENTINEL NODE DETECTION IN ESOPHAGEAL CANCER

To test the validity and feasibility of this concept in GI cancers, we propose a radio-guided intraoperative sentinel node procedure using preoperative endoscopic submucosal injection of radioactive tracer followed by intra-operative gamma-probing.

Feasibility of Pre-emptive VACStent Placement after Ivor Lewis Esophagectomy, to Prevent Anastomotic Leakage (PREVENT feasibility study)

We aim to evaluate the technical and logistic feasibility and safety of pre-emptive VACStent placement in patients undergoing esophagectomy with gastric conduit reconstruction, to prevent anastomotic leakage by early endoscopic vacuum therapy (EVT…

IM011-127 A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Study IM011-127 is a Phase 2 randomized, double-blind, placebo-controlled, multicenter clinical study designed to assess the safety and tolerability, efficacy and biomarker response of BMS-986165 12 mg BID in subjects with moderate to severe…

A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and α4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects

The sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).