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NCT ID: NCT01484483 Completed - Breast Cancer Clinical Trials

An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

Start date: August 8, 2011
Phase:
Study type: Observational

This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.

NCT ID: NCT01481181 Completed - Diarrhoea Clinical Trials

An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc

Start date: August 2011
Phase: N/A
Study type: Interventional

In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element that has a critical role in growth and immunity. Supplementation with zinc is considered effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of the study is to assess the efficacy of LSF to increase the zinc status (serum zinc concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study hypotheses are: A. Use of the LSF device will reduce microbiological contamination of the household supply of drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool children; C. Use of the LSF device will increase serum zinc concentration in preschool children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A, B and C will reduce the frequency and duration of diarrheal disease in preschool children and in members of the participating households.

NCT ID: NCT01468753 Completed - Clinical trials for HIV Discordant Couples

Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya

Start date: March 2012
Phase: N/A
Study type: Interventional

To evaluate the acceptability, feasibility, and efficacy of vaginal insemination as a method of conception in HIV discordant couples (female positive, male negative) desiring pregnancy in Kisumu, Kenya

NCT ID: NCT01435018 Completed - HIV-1 Infection Clinical Trials

Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS

Start date: October 1, 2013
Phase: Phase 3
Study type: Interventional

This study was done to compare the safety and efficacy of three combination treatments for Kaposi's Sarcoma (KS) and AIDS: 1. Etoposide (ET) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) (ET+ART), 2. Bleomycin and Vincristine (BV) plus co-formulated EFV/FTC/TDF (BV+ART), 3. Paclitaxel (PTX) plus co-formulated EFV/FTC/TDF (PTX+ART).

NCT ID: NCT01433185 Completed - HIV Infections Clinical Trials

Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV

SMS4PMTCT
Start date: April 2012
Phase: N/A
Study type: Interventional

Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.

NCT ID: NCT01428830 Completed - Vaginal Fistula Clinical Trials

Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Start date: January 2012
Phase: N/A
Study type: Interventional

This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.

NCT ID: NCT01427738 Completed - HIV-1 Infection Clinical Trials

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see which one of two medicines (topical gentian violet [GV] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.

NCT ID: NCT01425073 Completed - HIV Infections Clinical Trials

Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya

Start date: February 2012
Phase: N/A
Study type: Interventional

Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been associated with significantly decreased mortality in HIV-infected individuals. Trimethoprim-sulfamethoxazole (TMP/SMZ), also known as bactrim, is a common antibiotic and used as prophylaxis for OIs. For countries with high prevalence of HIV and limited health infrastructure, the WHO endorses universal TMP/SMZ for all HIV-infected individuals. Notably, these guidelines were created prior to the scale-up of ARTs. Following ART and subsequent immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for example, TMP/SMZ is discontinued after patients show evidence of immune recovery. Therefore, we propose a prospective randomized trial among HIV infected individuals on ART with evidence of immune recovery (ART for > 18mo and CD4 >350 cells/mm3) to determine whether continued TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea), mortality, CD4 count maintenance, ART treatment failure and malaria immune responses.

NCT ID: NCT01404312 Completed - HIV Infections Clinical Trials

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Start date: May 23, 2012
Phase: Phase 3
Study type: Interventional

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

NCT ID: NCT01399723 Completed - Pneumonia Clinical Trials

Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia

Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.