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NCT ID: NCT00383578 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

NCT ID: NCT00383006 Withdrawn - Clinical trials for Stress Disorders, Post-Traumatic

Affect Management Group for Adult Survivors of Childhood Trauma

Start date: May 2006
Phase: Phase 1
Study type: Interventional

Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. The hypothesis is that the group therapy significantly improves the participant's capacity in emotion management and self-soothing.

NCT ID: NCT00382720 Completed - Stomach Neoplasms Clinical Trials

Docetaxel and Oxaliplatin in Gastric Cancer

Start date: September 2006
Phase: Phase 2
Study type: Interventional

This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective: - To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives: - To establish the safety profile. - To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria - To assess the Overall Survival (OS)

NCT ID: NCT00382421 Completed - Myocardial Ischemia Clinical Trials

Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

Start date: February 1992
Phase: N/A
Study type: Interventional

There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

NCT ID: NCT00381680 Completed - Clinical trials for B-cell Childhood Acute Lymphoblastic Leukemia

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..

NCT ID: NCT00379470 Completed - Clinical trials for Recurrent Glioblastoma Multiforme

Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

NCT ID: NCT00379457 Recruiting - Sarcoma Clinical Trials

Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

Start date: June 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma.

NCT ID: NCT00379340 Active, not recruiting - Clinical trials for Stage III Kidney Wilms Tumor

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Start date: February 26, 2007
Phase: Phase 3
Study type: Interventional

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

NCT ID: NCT00378014 Completed - Clinical trials for Liver Transplantation

Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Start date: August 2006
Phase: Phase 3
Study type: Interventional

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

NCT ID: NCT00376272 Completed - Atrial Fibrillation Clinical Trials

GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Start date: November 2004
Phase: Phase 3
Study type: Interventional

Study purpose The purpose of the study is to show that the addition of valsartan on top of established therapies can reduce the recurrence of atrial fibrillation in patients with a history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities. Primary objective To demonstrate that, in patients with history of recent atrial fibrillation treated with the best recommended therapies, the addition of valsartan 320 mg is superior to placebo in reducing atrial fibrillation recurrence. Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo controlled study. Patients with a history of atrial fibrillation will be centrally randomized in a 1:1 ratio to receive either valsartan or placebo. GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. The enrollment period will last 12 months. The patients will be followed up for 12 months from study entry All prescribed treatments for AF or for the underlying cardiovascular diseases, including ACE-inhibitors, amiodarone and betablockers, will be allowed: - patients should be on a stable treatment for at least one month - the current guideline for hypertension treatment should be applied - patients should not be started on ARBs during the study