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NCT ID: NCT00729235 Completed - Clinical trials for Biventricular Tachycardias

Biventricular Tachycardias Outcome Trial

BITAC
Start date: May 2006
Phase: Phase 4
Study type: Interventional

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows: - Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm) - VT detection rate: 150 bpm PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

NCT ID: NCT00727428 Completed - Influenza Clinical Trials

Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

Start date: August 5, 2008
Phase: Phase 1
Study type: Interventional

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.

NCT ID: NCT00726440 Completed - Type 1 Diabetes Clinical Trials

Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?

Start date: February 2008
Phase: N/A
Study type: Interventional

The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.

NCT ID: NCT00725985 Completed - Multiple Sclerosis Clinical Trials

Oral Cladribine in Early Multiple Sclerosis (MS)

ORACLE MS
Start date: December 31, 2008
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

NCT ID: NCT00725439 Completed - Acne Clinical Trials

An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne

Start date: September 2004
Phase: Phase 2
Study type: Interventional

This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.

NCT ID: NCT00724503 Completed - Colorectal Cancer Clinical Trials

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

SIRFLOX
Start date: August 2006
Phase: N/A
Study type: Interventional

This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

NCT ID: NCT00723047 Completed - Crohn's Disease Clinical Trials

Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

Fibrin glue
Start date: November 2003
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)

NCT ID: NCT00722579 Completed - Clinical trials for Coronary Artery Disease

A Study of the Presillion Stent in de Novo Coronary Lesions

PRESILLION
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic heart disease attributable to a stenotic de novo lesion in a native coronary artery. The study population will include 100 patients with up to two de novo native coronary artery lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries with reference vessel diameter >= 2.5mm and <= 4.0mm by visual estimation. Patients will be followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse events.

NCT ID: NCT00722566 Completed - Multiple Myeloma Clinical Trials

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

Start date: July 2008
Phase: Phase 3
Study type: Interventional

Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

NCT ID: NCT00722553 Completed - Bladder Cancer Clinical Trials

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).