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NCT ID: NCT00984126 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Start date: October 26, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

NCT ID: NCT00983801 Completed - Stomach Neoplasms Clinical Trials

Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

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

The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.

NCT ID: NCT00982397 Completed - Heart Failure Clinical Trials

Safety and Clinical Performance of the Protecta ICD and CRT-D

Start date: September 2009
Phase: N/A
Study type: Interventional

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

NCT ID: NCT00981409 Completed - Embolism, Pulmonary Clinical Trials

The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

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

The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.

NCT ID: NCT00981006 Completed - Clinical trials for Congestive Heart Failure

AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)

ALCADIA
Start date: April 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).

NCT ID: NCT00980590 Completed - Intubation Clinical Trials

Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

Start date: September 2008
Phase: N/A
Study type: Interventional

Pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. It is thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the ground.

NCT ID: NCT00980460 Active, not recruiting - Clinical trials for PRETEXT II Hepatoblastoma

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

Start date: September 14, 2009
Phase: Phase 3
Study type: Interventional

This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.

NCT ID: NCT00980447 Completed - Influenza Clinical Trials

Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

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

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

NCT ID: NCT00980317 Recruiting - Renal Insufficiency Clinical Trials

A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Third Parties

Start date: July 2009
Phase: N/A
Study type: Interventional

Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered to the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly come back to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors. Due to the fact that the number of deceased donors are scarce and renal transplantations between non-relatives (third parties) are currently not allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation. There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan. Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurence of renal cancer) of living renal transplantations between third parties (non-relatives) with restored donor kidneys after the surgical removal of a small size (4 cm or less) renal tumor, in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for our patients who are on dialysis for many years due to the renal failure.

NCT ID: NCT00980057 Completed - Heart Failure Clinical Trials

Adaptive Cardiac Resynchronization Therapy Study

aCRT
Start date: October 1, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance