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NCT ID: NCT00171821 Completed - Clinical trials for Transfusion-dependent Iron Overload

A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-dependent Iron Overload

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

NCT ID: NCT00171704 Completed - Clinical trials for Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women

A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis. This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.

NCT ID: NCT00170287 Completed - Clinical trials for Tachycardia, Ventricular

SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)

SMS
Start date: May 2002
Phase: Phase 4
Study type: Interventional

The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions. The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.

NCT ID: NCT00169494 Completed - Clinical trials for Infections, Papillomavirus

Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

Start date: September 2004
Phase: Phase 3
Study type: Interventional

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

NCT ID: NCT00169013 Completed - Clinical trials for Amputation of Lower Limb

Gabapentin in Phantom and Stump Pain

Start date: May 2002
Phase: Phase 4
Study type: Interventional

To investigate whether gabapentin can prevent phantom and stump pain after amputation.

NCT ID: NCT00168974 Completed - Fabry Disease Clinical Trials

Neuropathic Pain and Fabry Disease

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

Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids in the vascular endothelial cells and many other tissues. An early sign of the disease is painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the X-linked inheritance, male patients are severely affected. Recently attention has been drawn to female patients whether they also show signs of nerve involvement. The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients. Correlation with X-chromosome inactivation will be attempted. Recombinant human α-galactosidase A is now available for patients. A part of this study is evaluation the long term efficacy of enzyme replacement therapy in female patients with Fabry disease and neuropathy. Male family members with Fabry disease will be examined.

NCT ID: NCT00168818 Completed - Thromboembolism Clinical Trials

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

NCT ID: NCT00168805 Completed - Clinical trials for Arthroplasty, Replacement, Knee

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

Start date: November 2004
Phase: Phase 3
Study type: Interventional

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

NCT ID: NCT00168766 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

Start date: January 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

NCT ID: NCT00166244 Completed - Clinical trials for De Novo Renal Transplant Recipient.

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.