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NCT ID: NCT01271504 Completed - Clinical trials for Hepatocellular Carcinoma

E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma

Start date: July 19, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.

NCT ID: NCT01270464 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.

NCT ID: NCT01270282 Completed - Tinnitus Clinical Trials

Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus

TACTT1
Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.

NCT ID: NCT01269970 Completed - Clinical trials for Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)

Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

Start date: January 2004
Phase: N/A
Study type: Observational

Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer treated by neoadjuvant CRT and esophagectomy.

NCT ID: NCT01268514 Completed - Hernia, Abdominal Clinical Trials

ENHANCE: A Prospective EvaluatioN of Permacolâ„¢ in tHe Repair of Complex AbdomiNal Wall CasEs

ENHANCE
Start date: February 2011
Phase:
Study type: Observational

The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacolâ„¢ Biological Implant in the treatment of complex abdominal wall defects

NCT ID: NCT01268241 Completed - Fabry Disease Clinical Trials

The Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement in Patients With Anderson-Fabry Disease

SWITCH
Start date: December 2010
Phase:
Study type: Observational

The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been commercially available in Europe for almost 10 years, yet little information is available about the clinical and safety profile of patients who switch from one therapy to the other. An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of these patients received a reduced dosage of Fabrazyme® for an extended period before transitioning to treatment with Replagal®.

NCT ID: NCT01268033 Completed - Clinical trials for Childhood Idiopathic Nephrotic Syndrome

Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood

NEPHRUTIX
Start date: December 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Background Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine). Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern. Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect. Purpose The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome. Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.

NCT ID: NCT01267084 Completed - Neoplasm Metastases Clinical Trials

A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the potential effects of ketoconazole on blood levels of trabectedin after administration to patients with advanced malignancies.

NCT ID: NCT01266902 Completed - HIV-1 Infection Clinical Trials

A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

NCT ID: NCT01266252 Completed - Clinical trials for Mechanically-ventilated Neonates With Single-organ Respiratory Failure

Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure.

NEODEX
Start date: July 28, 2011
Phase: Phase 3
Study type: Interventional

Clinical experience with dexmedetomidine in the paediatric population is limited. Critical illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.