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NCT ID: NCT00371735 Completed - Malaria, Falciparum Clinical Trials

Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria

Start date: April 2006
Phase: Phase 3
Study type: Interventional

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug. The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.

NCT ID: NCT00367523 Completed - Sickle Cell Disease Clinical Trials

Pulmonary Hypertension in Patients With Sickle Cell Disease in Nigeria

Start date: June 15, 2006
Phase:
Study type: Observational

This study will explore how people with sickle cell disease (SCD) develop a complication called pulmonary hypertension (PHTN), a serious disease in which blood pressure in the lungs is higher than normal. PHTN is also caused by HIV, hepatitis C and schistosomiasis. Patients who have both SCD and one of these other infections may develop more severe PHTN. The number of Nigerians with SCD who also have PHTN is not known, nor is the cause of PHTN in this population. This study will examine genetic material in people with and without SCD to determine whether certain genes will allow doctors to predict which patients with SCD are likely to develop PHTN. Nigerian males and females 10 years of age and older with or without SCD may be eligible for this study. Patients must have SS, SC, or SB thalassemia or other genotype; control subjects must have hemoglobin A or AS genotype. Participants undergo a complete medical history and physical examination, blood tests, electrocardiogram (EKG), ultrasound tests of the heart and abdomen, and a 6-minute walk (distance test) to determine exercise capacity. Blood tests include screening for HIV, hepatitis B and C, schistosomiasis, hookworm and malaria. Patients who test positive for HIV, hepatitis B or C, schistosomiasis, hookworm or malaria are referred for treatment at Ahmadu Bello University Teaching Hospital in Zaria, Nigeria, and those who test negative for hepatitis B are referred for vaccination. Genetic tests focus on genes involved in SCD, PHTN, inflammation, blood vessel function and red blood cell function.

NCT ID: NCT00347438 Terminated - Breast Cancer Clinical Trials

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

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

The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery. The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.

NCT ID: NCT00344006 Completed - Malaria, Falciparum Clinical Trials

Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

Start date: June 2006
Phase: Phase 3
Study type: Interventional

Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency. CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum. Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.

NCT ID: NCT00293540 Completed - Breast Cancer Clinical Trials

Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

Start date: February 2006
Phase: Phase 3
Study type: Interventional

This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

NCT ID: NCT00130078 Recruiting - HIV Infections Clinical Trials

Trial of SAVVY Vaginal Gel and HIV in Nigeria

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

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

NCT ID: NCT00124540 Completed - Clinical trials for Postpartum Hemorrhage

Misoprostol for Preventing Postpartum Hemorrhage

Start date: August 2005
Phase: N/A
Study type: Interventional

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

NCT ID: NCT00122486 Completed - HIV Infections Clinical Trials

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.

NCT ID: NCT00120770 Terminated - HIV Infections Clinical Trials

Cellulose Sulfate (CS) Gel and HIV in Nigeria

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

This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.

NCT ID: NCT00023049 Completed - Clinical trials for Sensorineural Hearing Loss

Genetic Analysis of Hereditary Disorders of Hearing and Balance

Start date: December 23, 2002
Phase:
Study type: Observational

This study will try to identify the genetic causes of hereditary hearing loss or balance disorders. People with a hearing or balance disorder that affects more than one family member may be eligible for this study. They and their immediate family members may undergo some or all of the following procedures: - Medical and family history, including questions about hearing, balance and other ear-related issues, and review of medical records. - Routine physical examination. - Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is collected for DNA analysis to look for changes in genes that may be related to hearing loss. - Hearing tests - The subject listens for tones emitted through a small earphone. - Balance tests to see if balance functions of the inner ear are associated with the hearing loss In one test the subject wears goggles and watches moving lights while cold or warm air is blown into the ears. A second test involves sitting in a spinning chair in a quiet, dark room. - Photograph - A photograph may be taken as a record of eye shape and color, distance between the eyes, and hair color. - Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show the structure of the inner ear. For CT, the subject lies still for a short time while X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a cylindrical machine with a strong magnetic field. The magnetic field and radio waves produce images of the inner ear. The radio waves cause loud thumping noises that can be muffled by the use of earplugs.