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NCT ID: NCT00304837 Completed - Clinical trials for Critical Limb Ischemia

VEGF Gene Transfer for Critical Limb Ischemia

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.) VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries. The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study. This study has been approved by the Food and Drug Administration (FDA).

NCT ID: NCT00306514 Completed - Melanoma Clinical Trials

Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.

NCT ID: NCT00306553 Completed - Malignant Melanoma Clinical Trials

Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.

NCT ID: NCT00306566 Completed - Malignant Melanoma Clinical Trials

Safety and Immunogenicity of a Melan-A VLP Vaccine in Early Stage Melanoma Patients

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

NCT ID: NCT00308477 Completed - Clinical trials for Macular Degeneration

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.

NCT ID: NCT00308542 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

NCT ID: NCT00308698 Completed - Renal Dialysis Clinical Trials

Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)

Start date: n/a
Phase: N/A
Study type: Observational

High recombinant human erythropoietin requirement and elevated serum adiponectin were significant determinants of long-term mortality in patients who started hemodialysis therapy.

NCT ID: NCT00308841 Completed - Lost IUD Clinical Trials

Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD). Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2.

NCT ID: NCT00309582 Completed - Adverse Event Clinical Trials

Nevirapine Levels and Fluconazole

Start date: n/a
Phase: N/A
Study type: Observational

Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.

NCT ID: NCT00309725 Completed - Alzheimer's Disease Clinical Trials

A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.

Start date: n/a
Phase: Phase 3
Study type: Interventional

The objective of this trial was to investigate the effect of galantamine (an acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the heart's electrical impulse to get from the atria to the ventricles) during the administration of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in patients with Alzheimer's disease.