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NCT ID: NCT00370357 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

SPL7013 Gel - Male Tolerance Study

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if SPL7013 Gel (VivaGelâ„¢) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.

NCT ID: NCT00370084 Completed - Gastroparesis Clinical Trials

Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

NCT ID: NCT00369850 Completed - Breast Cancer Clinical Trials

Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98

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

RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment. PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

NCT ID: NCT00369382 Completed - Kidney Failure Clinical Trials

Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

NCT ID: NCT00369317 Completed - Clinical trials for Secondary Acute Myeloid Leukemia

Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

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

This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

NCT ID: NCT00368641 Terminated - Clinical trials for Congestive Heart Failure

Heart Failure and Peritoneal Ultrafiltration

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.

NCT ID: NCT00368472 Completed - Epilepsy Clinical Trials

4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

Start date: October 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

NCT ID: NCT00368173 Completed - Laron Syndrome Clinical Trials

IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

NCT ID: NCT00367952 Completed - HIV Infection Clinical Trials

A Long Term, Safety Study of Apricitabine in HIV-infected Subjects

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

NCT ID: NCT00367770 Completed - Clinical trials for Pulmonary Arterial Hypertension

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Start date: January 2004
Phase: Phase 4
Study type: Interventional

This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.