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A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

The primary hypothesis of this study is that a dose-response relationship exists between disease activity as measured by the change from baseline in the Mayo score at Week 8 and JNJ-54781532 treatment regimens in subjects with moderately to severely…

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN*S DISEASE

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…

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn*s Disease who have Completed the MT-1303-E13 Study

Primary Objective:* To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CDSecondary Objectives:* To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to…

Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe Trial)

To investigate feasibility, safety and toxicity as well as immune-response of an allogeneic tumor cell lysate (PheraLys) loaded onto autologous dendritic cells (MesoPher) in resected pancreatic cancer patients who received adjuvant standard of care…

Addition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasability (LAPC-1)

This is a prospective phase II non-randomized single-center study in patients with LAPC. Patients are first treated with up to 8 cycles of FOLFIRINOX, followed by stereotactic radiotherapy for a total dose of 40 Gy in 5 fractions. Due to the known…

Non invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial

Primary Objective: Visualization and quantification of tumor hypoxia with [18F] HX4 PET imagingSecondary Objectives: - Correlation of [18F] HX4 with local tumor recurrence and survival- Correlation of hypoxia imaging with blood hypoxia markers -…

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn*s Disease

Primary Objectives* To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active CD* To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.Secondary Objectives* To explore the PK…

Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced and locally recurrent pancreatic carcinoma.

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM
SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA II)

The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…

Topical treatment of perianal dermatitis with potato protease inhibitor cream in children after colorectal surgery.

To address the hypothesis that a potato derived protease inhibitor cream significantly limits perianal dermatitis in patients after colorectal surgery.

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis

Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…

A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients

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.

Human intestinal ischemia and reperfusion

This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…

Node study: 'Esophageal resection for patients with esophageal cancer and cervical lymph node metastases'

To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases in level III and/ or…

Organoids of Barrett*s esophagus:
a feasibility study and creation of a Biobank

Primary Objectives: - To test the feasibility of culturing patient-derived Barrett*s esophagus organoids- To test pharmacological and chemotherapeutical agents in vitro on the cultured organoidsSecondary Objectives: - To create a small Biobank (of…

Improved screening of esophageal cancer by optical detection of field cancerization.

1. Evaluate the feasibility of ESS for detection of field cancerization in BE patients. 2. Investigate the biological background of field cancerization by studying: a) (ultra)structural changes in the tissue and b) genetic abnormalities and clonal…

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY
TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004)
FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Primary ObjectiveTo evaluate the clinical efficacy of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active UC.Secondary Objective To evaluate the safety and tolerability of apremilast (30 mg BID and 40…

A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL)

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…

An uncontrolled, pilot-study assessing the efficacy of octreotide LAR to decrease transfusion requirements and endoscopy frequency in patients with Rendu-Osler-Weber and gastrointestinal bleeding

To assess the efficacy of octreotide LAR in decreasing the need for transfusions and endoscopic intervention in patients ROW with refractory anaemia due to gastrointestinal bleeding telangiectasias.