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NCT ID: NCT01651416 Completed - Malaria Clinical Trials

Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana

Start date: July 2012
Phase: Phase 4
Study type: Interventional

In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas. Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time. The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.

NCT ID: NCT01612442 Completed - Clinical trials for Improving Young Child Nutrition

Integrated Education Intervention to Improve Infant and Young Child Nutrition and Growth in Ghana

Start date: June 2010
Phase: N/A
Study type: Interventional

In Ghana the level of malnutrition is high among children below five years of age, particularly in rural areas. The objective of the study was to investigate the effects of an education intervention aimed at addressing poor complementary feeding (CF) practices on the food intakes and growth of young children in the Upper Manya Krobo district of Ghana. Interviews and focus group discussions involving community health and agricultural workers, as well as caregivers of children 6-24 months old were conducted to investigate the facilitators and challenges to optimal CF practices and education on CF. The trials of improved practices (TIPs) method was used to test the feasibility and acceptability of potential education messages among mothers of young children (6-24 months) living in the study area. Child welfare clinic centers in the area were randomly assigned to one of three groups which were control, nutrition education and integrated education. Mothers of children 6-24 months in the integrated education group received monthly nutrition education from community health volunteers and agricultural education from agricultural extension agents for six months in addition to standard monthly child growth monitoring services from community health nurses. Mothers in the nutrition education group received monthly nutrition education from community health volunteers for six months in addition to standard care. Mothers of 6-24 months in the control group received only the standard monthly child monitoring services. The effects of the educational intervention on maternal knowledge on optimal complementary feeding, as well as food intakes and growth of young children were determined among 367 mother-child dyads over a period of at least six months. The study hypothesised that mothers receiving the education would have improved knowledge on good complementary feeding practices compared to those in the control group. The study also hypothesised that young children in the integrated education would have better nutrient intakes and growth compared those in the nutrition education and control groups, and those in the nutrition education group would have better nutrient intakes and growth than the children in the control group. From the interviews and focus group discussions, reported initiation of CF was satisfactory, while other reported practices such as the addition of animal source foods, vegetables and fruits to young children's diet were found to be sub-optimal. Poverty and maternal time constraints were identified as the main challenges of optimal complementary feeding, while farming was seen as a facilitator. Lack of education materials, language barrier, maternal time constraints and lack of in-service training for health workers were the main challenges to education on complementary feeding. From the TIPS study, mothers expressed their willingness to improve the diets of their 6-24 months old children by adding or increasing the amount of animal source foods, dark-green leafy vegetables and fruits, as well as increasing feeding frequency daily. However, availability and affordability of protein-rich foods like animal source foods, groundnut paste and soya beans powder was a challenge for some mothers. The intervention did not lead to a significant improvement in maternal knowledge on complementary feeding practices. However, it showed a tendency to reverse a general decreasing trend in knowledge among mothers on appropriate complementary feeding practices in the study area. Significantly more children in the integrated education group consumed animal source foods compared those in the other two groups when compared at nine months after baseline. However, the intervention did not improve the general nutrient intakes and growth of the young children in the study area.

NCT ID: NCT01575197 Completed - Clinical trials for Rotavirus Gastroenteritis

Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.

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: NCT01345240 Completed - Malaria Clinical Trials

Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

Start date: November 17, 2011
Phase: Phase 3
Study type: Interventional

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

NCT ID: NCT01335490 Completed - Pneumonia Clinical Trials

Intervening to Improve Infant Health in Ghana

Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies. The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana. Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns. Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first 12 months of life.

NCT ID: NCT01258049 Completed - Clinical trials for Plasmodium Falciparum Malaria

Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

NCT ID: NCT01243138 Completed - Obesity Clinical Trials

Africa and Middle East Cardiovascular Epidemiological Study

ACE
Start date: July 2011
Phase:
Study type: Observational

This is a cross-sectional, epidemiological study to determine the prevalence of cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension in patients attending General Practice clinics in the Africa and Middle East region. A total of 4300 patients will be evaluated. In patients who are found to have previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or hypertension, the level of control of their respective conditions will also be evaluated.

NCT ID: NCT01231113 Completed - Clinical trials for Pregnancy Complicated by Malaria as Antepartum Condition

Efficacy,Safety and Tolerability of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Pregnancy in Ghana

DHAPPQ/MIP
Start date: July 2011
Phase: Phase 3
Study type: Interventional

Malaria in pregnancy poses enormous public health challenges, contributing to significant maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility to malaria and mediate these adverse outcomes. The World Health Organization recommends treatment with artemisinin-combination therapy. Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine (AS-AQ) and quinine again are used in later trimesters. Recent amendments added artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in several studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible and available following its inclusion in the national malaria guidelines and may inadvertently be used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in pregnancy makes it pertinent to study its safety, tolerability and efficacy in pregnancy. We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42, prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages will be described at 95% Confidence Intervals and compared using chi-square tests. Parametric and non-parametric tests of significance will be applied as appropriate to determine significance of differences in outcomes between the treatment groups.