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NCT ID: NCT01991652 Recruiting - Wilms Tumour Clinical Trials

Collaborative Wilms Tumour Africa Project

Start date: January 2014
Phase:
Study type: Observational

Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment. A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year. The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

NCT ID: NCT01704144 Recruiting - HIV Clinical Trials

Rifampin and Efavirenz Interactions in Older Children

Start date: October 2012
Phase: N/A
Study type: Observational

Efavirenz is an essential component of HIV treatment in children aged 3 years or older on anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during anti-TB treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the drug metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between the HIV and anti-TB drugs also vary between individuals based on genetic factors. This study will investigate the effects of anti-TB treatment, as well as drug-gene interactions on the blood concentrations of efavirenz in children with HIV and TB infections. Such data could enhance optimization of efavirenz dosage or selection of alternate regimens in some children.

NCT ID: NCT01699633 Recruiting - HIV Clinical Trials

Rifampin and Nevirapine Interactions in Young Children

Start date: October 2012
Phase: N/A
Study type: Observational

Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for treatment of HIV in children younger than 3 years old who have tuberculosis (TB) coinfection. However, there is very limited data on the drug-drug interactions between rifampin and nevirapine in children of this age group. The purpose of this study is to determine the effect of rifampin-containing anti-TB treatment on the blood levels of nevirapine in young children with HIV and TB coinfection. Also, the study will find out whether checking the genetic makeup of a child could help to determine the appropriate dose of nevirapine in the setting of concomitant anti-TB treatment.

NCT ID: NCT01687504 Recruiting - HIV Clinical Trials

Pharmacokinetics of Anti-TB Drugs in HIV/TB Co-infected Children in Ghana

Start date: October 2012
Phase: N/A
Study type: Observational

Tuberculosis (also known as TB) is a common infection and a major cause of death in children. Effective treatment using a combination of anti-tuberculosis (anti-TB) medications saves lives, but dosages of these medications are not well established in children. Several research studies have shown that the recommended dosages of the anti-TB medications in children do not lead to adequate blood levels to kill the bacteria in some children. This situation may lead to treatment failure and emergence of drug resistance. As a result, the world Health Organization (WHO) recently recommended increased dosages for all the TB medications in children. This study is being conducted to find out if the increased dosages of the anti-TB drugs are safe and lead to adequate drug levels in the blood of children with TB with or without HIV infection.

NCT ID: NCT01459146 Recruiting - Anemia Clinical Trials

Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana

ACTIPT
Start date: December 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration.

NCT ID: NCT01452672 Recruiting - Breast Cancer Clinical Trials

Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer

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

This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa. Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule. Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.

NCT ID: NCT00837122 Recruiting - Hypertension Clinical Trials

Genetics of Type 2 Diabetes in West Africans

Start date: February 3, 2009
Phase:
Study type: Observational

Background: - Type 2 diabetes (T2D) and associated complications are major contributors to the global disease burden. T2D is already a major health threat in populations in developed countries and is rapidly taking hold in the developing world. - It is believed that understanding the complex interplay between genetic and lifestyle characteristics in the etiology of T2D and related complications will lead to the development of better preventive and therapeutic strategies. In Addition, the results of this project will facilitate our understanding of causes of diabetes in African Americans, other US and world populations Objectives: - To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among the Yoruba people in Ibadan, Nigeria. - To enroll and examine 300 unrelated cases of T2D and 300 ethnicity-matched Yoruba controls. - To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort. - To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples. - To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in West Africans. Eligibility: - Patients 18 years of age with confirmed T2D who are newly diagnosed or on treatment of Yoruba ethnicity in Ibadan, Nigeria. Control subjects are nondiabetics ethnically matched to patients. Design: - The study design for both patients and controls consists of the following steps: - Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff. - Assign study ID (barcode) - Administer questionnaires - Obtain spot urine sample - Measure blood pressure - Obtain anthropometric measurements including body composition - Perform finger prick for blood glucose level - Obtain venous blood samples - Perform eye examination - On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in Nigeria. - GWAS will be conducted using publicly available software packages.

NCT ID: NCT00532753 Recruiting - Clinical trials for To Better Understand How Epicenter's (Which House Education, Health and Finance Centers in Ghana) Increase Individual's Sense of Empowerment.

Evaluating the Hunger Project in Ghana

Start date: August 2007
Phase: Phase 0
Study type: Interventional

The Hunger Project/Epicenter strategy is a community based development strategy that will positively affect health, education, empowerment, and consumption.