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NCT ID: NCT01553877 Completed - Clinical trials for Moderately Malnourished Children

Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

Start date: January 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.

NCT ID: NCT01550016 Completed - Dengue Fever Clinical Trials

International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

IDAMS
Start date: October 2011
Phase: N/A
Study type: Observational

Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.

NCT ID: NCT01466933 Completed - Child Development Clinical Trials

Responsive Parenting Program for Infants in Rural Bangladesh

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

Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.

NCT ID: NCT01455636 Completed - Clinical trials for Infant, Low Birth Weight

Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

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

Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.

NCT ID: NCT01446926 Completed - Pneumonia Clinical Trials

Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective: - To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Secondary Objective: - To evaluate the immunogenicity of an investigational pneumococcal vaccine.

NCT ID: NCT01442727 Completed - Arsenical Keratosis Clinical Trials

Selenium in the Treatment of Arsenic Toxicity and Cancers

SETAC
Start date: December 2006
Phase: Phase 3
Study type: Interventional

Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients. Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.

NCT ID: NCT01439360 Completed - Influenza Clinical Trials

An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

NCT ID: NCT01438814 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

NCT ID: NCT01420406 Completed - Clinical trials for Vitamin A Deficiency

Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

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

The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.

NCT ID: NCT01407224 Completed - Malnutrition Clinical Trials

Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices

iycfch
Start date: May 2010
Phase: Phase 1
Study type: Interventional

The aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and increase early exclusive breastfeeding in research areas of rural Bangladesh.