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NCT ID: NCT00835250 Completed - Cholelithiasis Clinical Trials

Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Start date: February 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

NCT ID: NCT00835185 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of IMC-11F8 in Participants With Colorectal Cancer

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

NCT ID: NCT00833703 Completed - Clinical trials for Heart Defects, Congenital

Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

CLARINET LT
Start date: January 2009
Phase: Phase 3
Study type: Interventional

This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age. The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

NCT ID: NCT00833352 Completed - Clinical trials for Ventricular Tachycardia

Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

SEPTAL-CRT
Start date: November 2008
Phase: N/A
Study type: Interventional

This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator. 1. Purpose : To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months. 2. Objectives: The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months. The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes. This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study. All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.

NCT ID: NCT00833248 Completed - Prostate Cancer Clinical Trials

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Start date: April 2009
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.

NCT ID: NCT00832975 Completed - Atrial Fibrillation Clinical Trials

AVAI: Atrial Ventricular Arrythmia Incidence

AVAI
Start date: December 2008
Phase:
Study type: Observational

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

NCT ID: NCT00831909 Completed - NSCLC Clinical Trials

Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN

EPICLIN
Start date: January 2009
Phase: N/A
Study type: Observational

To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.

NCT ID: NCT00831714 Completed - Clinical trials for Venous Thromboembolism

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

XAMOS
Start date: February 2009
Phase: N/A
Study type: Observational

The main goal is to provide additional information to the risk-benefit assessment of the drug.

NCT ID: NCT00831220 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Start date: March 2005
Phase: N/A
Study type: Observational

Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.

NCT ID: NCT00831025 Completed - Clinical trials for Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

OLEA
Start date: January 2008
Phase: Phase 3
Study type: Interventional

The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.