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NCT ID: NCT00988325 Completed - Influenza Clinical Trials

A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection

Start date: January 2011
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

NCT ID: NCT00988221 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

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

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

NCT ID: NCT00988208 Completed - Prostate Cancer Clinical Trials

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Mainsail
Start date: November 11, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

NCT ID: NCT00988156 Completed - Clinical trials for Partial Epilepsy in Children and Adolescents

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Start date: December 7, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

NCT ID: NCT00987363 Completed - Diabetic Foot Clinical Trials

Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the lower limbs (CLI) without possibility of revascularization or other therapeutic alternatives. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and secrete also several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb

NCT ID: NCT00987337 Completed - Hepatitis C Clinical Trials

Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

FITNESS
Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

NCT ID: NCT00987142 Completed - Clinical trials for EPIDERMOLYSIS BULLOSA

Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa

TCEB
Start date: December 2006
Phase: Phase 2
Study type: Interventional

A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.

NCT ID: NCT00986414 Completed - Parkinson Disease Clinical Trials

Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Start date: September 2009
Phase: Phase 2
Study type: Interventional

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

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

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00984282 Completed - Thyroid Neoplasms Clinical Trials

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Start date: October 15, 2009
Phase: Phase 3
Study type: Interventional

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine