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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, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

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…

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…

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II)

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…

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.

Modulation of immune function by parenteral fish oil in patients with Crohn*s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study

To evaluate the effect of parenteral supplementation of fishoil based emulsion (rich in omega-3 fatty acids) compared with a soy bean oil emulsion (rich in omega-6 fatty acids) on the leukocyte functions (amongst others production of TNF-α and other…

A phase 2 study of EZN-2208 (PEG-SN38) administered with or without cetuximab in patients with metastatic colorectal carcinoma (mCRC)

Primary Objective• For Arms A, B, and C: Determine the overall response rate (RR) of EZN-2208 for two distinct cohorts of patients with mCRC- Patients with mutated K-RAS tumors (Arm A)- Patients with wild-type K-RAS tumors (Arms B and C)• For Arms B…

The safety, tolerability, and analgesic efficacy of Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain

Primary Objective: - To investigate the efficacy of Namisol® after a single dose of Δ9-THC on the experienced pain intensity (measured by the VASpain in rest and on movement) in patients with chronic pancreatitis.Secondary Objectives:- To…

A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

The primary objective of this study is to evaluate the tumor response of stable disease (SD), partial response, or complete response at at 12 weeks (according to RECIST 1.1 criteria) in two separate cohorts representing molecularly distinct subsets…

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

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures

To demonstrate that management of dysphagia for the treatment of refractory anastomotic esophageal strictures is more effective with Fully Covered metal stent than with Bougie Dilation.

Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced or recurrent rectal cancer patients undergoing curative surgery.

This study has been transitioned to CTIS with ID 2024-510768-21-00 check the CTIS register for the current data. This study aims to investigate if fluorescence guided surgery performed with SGM-101 can improve R0 resection rates and allows to find…

Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn*s Disease (CD): a pilot study

The primary objective is to evaluate the potential efficacy of personalized adjunctive antibiotic therapy in maintaining clinical remission in pediatric subjects undergoing SOC induction therapy for mild to moderate Crohn*s disease who have a…

Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)

Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…

A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment

This study has been transitioned to CTIS with ID 2023-510481-27-00 check the CTIS register for the current data. This study evaluates the yield of NIR-Fluorescence imaging as additional surgical-tool for visualization and assessment of local extent…

daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)

Safety Run-in (SRI) part:To confirm the recommended phase 2 dose (RP2D) of NIS793 or any other investigational drug(s), in combination with SOC anti-cancer therapy. In protocol amendment 1, an arm with tislelizumab has been added. In this arm, the…

A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC).

The primary objective is progression-free survival (PFS); defined as the time from randomization to the date of the first documented tumor progression; determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or death due…

A phase 2 intervention study:
Detection of early esophageal neopastic lesions by quantified fluorescence molecular endoscopy using oral and topical administration of bevacizumab-800CW and cetuximab-800CW

Primary objectives:The primary objectives are to evaluate the feasibility of oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE to shorten the qFME procedure and test whether…

Fecal Transplantation in adolescents with refractory Irritable Bowel Syndrome

In this study we would like to investigate whether fecal transplantation, administered through a nasoduodenal tube, from either allogenic or autologous donors, has beneficial efffects on IBS symptoms such as abdominal pain intensity and frequency,…