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NCT ID: NCT00537927 Completed - Ventral Hernia Clinical Trials

LACH-Trial: LAparoscopic Correction of Hernia

LACH
Start date: August 2005
Phase: N/A
Study type: Interventional

Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain. The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.

NCT ID: NCT00537836 Completed - Vasomotor System Clinical Trials

ZK283197 for Treatment of Vasomotor Symptoms

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

The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197 in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment of hot flushes. In order to be able to assess the efficacy of the test substance, this is compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a certified hormone preparation, which is already used for the treatment of hot flushes as standard treatment. After passing the screening, volunteers will start with a run-in phase followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot flushes and without relevant prior diseases will participate in three European countries (2 study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in this study.

NCT ID: NCT00537381 Completed - Prostatic Neoplasms Clinical Trials

An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer

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

The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body until it kills).

NCT ID: NCT00537303 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Start date: October 2007
Phase: Phase 4
Study type: Interventional

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

NCT ID: NCT00536861 Completed - Clinical trials for Non-Small Cell Lung Cancer

Safety Study of Radiotherapy and Concurrent Erlotinib (Tarceva®) for Brain Metastases From a Non-Small Cell Lung Cancer

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

Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments.

NCT ID: NCT00536081 Completed - Breast Cancer Clinical Trials

Various G-CSF Regimens to Prevent Infection During Chemotherapy

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

The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia. Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia. The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear. So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis.

NCT ID: NCT00535847 Completed - Hepatitis C Clinical Trials

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

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

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

NCT ID: NCT00535366 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

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

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

NCT ID: NCT00534859 Completed - Clinical trials for Patients Undergoing High Risk PCI.

PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

PROTECT I
Start date: August 2006
Phase: Phase 2
Study type: Interventional

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.

NCT ID: NCT00534222 Completed - Schizophrenia Clinical Trials

Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

UPTAQE
Start date: September 2005
Phase: N/A
Study type: Observational

With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.