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NCT ID: NCT00625378 Completed - Neoplasms Clinical Trials

Sorafenib Long Term Extension Program

STEP
Start date: December 21, 2007
Phase: Phase 3
Study type: Interventional

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

NCT ID: NCT00623467 Completed - Clinical trials for Central Nervous System Diseases

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

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

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

NCT ID: NCT00622869 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

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

This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.

NCT ID: NCT00615433 Completed - Schizophrenia Clinical Trials

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

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

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

NCT ID: NCT00614211 Completed - Cervical Cancer Clinical Trials

Laparoscopic Approach to Cervical Cancer

LACC
Start date: January 2008
Phase: N/A
Study type: Interventional

The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.

NCT ID: NCT00611507 Completed - Stomach Neoplasms Clinical Trials

A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer

Start date: November 2002
Phase: Phase 2
Study type: Interventional

This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer

NCT ID: NCT00611026 Completed - Overactive Bladder Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

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

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

NCT ID: NCT00609375 Completed - Sepsis Clinical Trials

Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

CEFPK/PD
Start date: September 2006
Phase: Phase 4
Study type: Interventional

To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.

NCT ID: NCT00605683 Completed - Clinical trials for Idiopathic Parkinson's Disease

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

MOTION
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.

NCT ID: NCT00605280 Completed - Clinical trials for Macular Edema Associated With Diabetes Mellitus

A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

Start date: September 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.