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NCT ID: NCT03305939 Recruiting - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Lifestyle Intervention IN Gestational Diabetes (LIVING)

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Burden: Diabetes mellitus is a major public health concern for both the developed and the developing countries. Globally 246 million people affected with diabetes, and will rise up to 300 million by 2025. In India, around 25% of the 25 million pregnancies are associated with gestational diabetes mellitus (GDM), and increasing rapidly over the time. Reported prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described. However, in Bangladesh, estimate varies from 9.7% to 12.9% when different criteria were used. Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate lifestyle intervention program will be more effective and cost effective relative to usual care in delaying incidence of T2D among women in South Asia. Evidence of developed countries indicate that a low-intensity lifestyle intervention, integrated with antenatal care in health system, optimizes healthy diet and attenuates physical activity decline in early pregnancy. Objective of the study: 1.To determine whether a resource- and culturally-appropriate lifestyle intervention program in Bangladesh , provided to women with prior gestational diabetes after delivery, will reduce the incidence of worsening of glycaemic status. 2. To explore whether the designated lifestyle intervention program is affordable, acceptable and scalable locally. Methods: Study design: An open-label parallel group pragmatic individual randomized controlled trial with blinded primary endpoint adjudication. The randomized controlled trial will be preceded by an intervention development and optimization phase. Intervention: Low intensity lifestyle modification program Duration: 4 years (48 months) Study settings: In Bangladesh, the investigators will conduct the intervention trial in 4 maternity care hospitals in Dhaka city. Sample size: A total of 1440 women with GDM from 24 hospitals (~60/hospital) will require for the RCT from 3 different countries. In Bangladesh, 360 participants from 4 selected maternity care hospitals (90 participants from each hospital, 45 cases and 45 controls) will be required. Inclusion Criteria: Absence of T2DM at 6±3months post-partum OGTT. Anticipated outcomes: Primary outcomes: Proportion of women with a change of glycaemic category, at or prior to final visit: Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; and/or impaired fasting glucose/impaired glucose tolerance to type 2 Diabetes Mellitus (DM) Secondary outcomes: Mean changes in Body weight, Mean changes in waist circumference, Mean changes in systolic blood pressure, mean changes in fasting blood glucose, increase physical activity level from low to moderate and increase fruits and vegetable consumption, incremental cost effectiveness ratio and feasibility of intervention.

NCT ID: NCT03281980 Enrolling by invitation - Child Development Clinical Trials

Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour. Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development. Primary Hypothesis (if any): - Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group. - Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups Secondary Hypothesis: Additionally the intervention will - be cost effective, - reduce mothers' depressive symptoms and improve their self esteem - improve children's growth and household food security status - reduce domestic violence - Health seeking behaviour and health care expenditure Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country. Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.

NCT ID: NCT03269006 Enrolling by invitation - Clinical trials for Visceral Leishmaniasis

Improved Case Detection and Vector Control for Visceral Leishmaniasis

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study we propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.

NCT ID: NCT03263403 Not yet recruiting - Clinical trials for Meningococcal Vaccine

Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.

Start date: September 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Menomune®- A/C/Y/W-135 on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Menomune® - A/C/Y/W which is produced by Sanofi Pasteur Inc. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Menomune® - A/C/Y/W-135.

NCT ID: NCT03259269 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Expand New Drugs for TB [endTB]

Start date: February 9, 2016
Phase: N/A
Study type: Observational

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

NCT ID: NCT03258385 Not yet recruiting - Early Pregnancy Clinical Trials

Vitamin B12 Supplementation to Improve B12 Status and Child Development

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

Start date: January 1, 2002
Phase: N/A
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03208725 Recruiting - Sepsis Clinical Trials

Childhood Acute Illness and Nutrition Network

Start date: November 2016
Phase: N/A
Study type: Observational

The CHAIN Network aims to identify modifiable biomedical and social factors driving the greatly increased risk of mortality among young undernourished children admitted to hospital with acute illness, as inpatients and after discharge. The study will inform priorities, risks and targeting for multi-faceted interventional trials. CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological samples. Study sites are located in Africa and South Asia. Children will be recruited at admission to hospital, stratified by nutritional status. Exposures will be assessed at admission, during hospitalisation, at discharge, and at two time points after discharge. The main outcomes of interest are mortality, re-admission to hospital and failure of nutritional recovery up to 180 days after discharge. To determine community health norms, an additional sample of children living in the same communities will be enrolled and assessed at one time point only.

NCT ID: NCT03202719 Not yet recruiting - Poliomyelitis Clinical Trials

Duration of IPV Priming and Antibody Decay

Start date: July 31, 2017
Phase: Phase 4
Study type: Interventional

This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.

NCT ID: NCT03189004 Recruiting - Vaccination Clinical Trials

Assessing the Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh Through Pilot Intervention

Start date: April 2016
Phase: N/A
Study type: Interventional

1. Burden: In global perspective, it is estimated that the lives of 150,000 women could be saved each year worldwide with access to sufficient family planning services. It is indicated that only 26 percent women received four or more antenatal care (ANC) visits during their pregnancies, while 67.7 percent received at least one ANC during their pregnancies which are the great challenges for ensuring safe motherhood in the country. As a part of safe motherhood, it is estimated that only 28.8 percent deliveries are being conducted in health facilities in the country. In case of postnatal care (PNC), from 2008 to 2010, only 27 percent of women received PNC for their last deliveries from a medically-trained provider within two days of their delivery. Despite the tremendous success of expanded programme on immunization (EPI) in Bangladesh, a substantial number of children are not fully vaccinated under EPI as data shows 82 percent were fully vaccinated by the age of 12 months. 2. Knowledge gap: Use of technology for covering all or major components of primary health care (PHC) is yet to be developed and tested in Bangladesh. Further, no such initiative has yet been taken focusing community clinic (CC) to ensure equity of services in Bangladesh. 3. Relevance: At present in Bangladesh, the CCs cater the services on family planning, maternal neonatal and child health (MNCH), health education for the rural people by using e-health strategy as the community health care provider (CHCP), newly recruited staff of community clinic are equipped with internet connected laptop service. So, updated technology for updating information, follow up and referral in primary health care can be used to increase the utilization of health services. Hypothesis (if any): Use of smart phones by community level healthcare providers will increase utilization of reproductive health (RH) and family planning (FP), MNCH, integrated management of childhood illness (IMCI), EPI and other PHC services at rural communities in Bangladesh. Objectives: To develop and test a mechanism as well as assess the impact of mHealth strategy to improve RH and FP, MNCH, IMCI, EPI and other PHC services in rural communities of Bangladesh. Methods: The service delivery personnel who are providing the services to the community people at different levels (community clinic, union health and family welfare centre, upazila health complex) will be equipped with smart phones having the facilities for text messages, voice messages as well as internet and data capturing. Training on handling of the smart phones, data capturing and monitoring will be provided to service providers in each upazila. They will be trained to input, edit, verify and monitor the data on different services through the software installed in their smart phones. The community clinic management and support groups will be oriented and motivated on mobile phone based registration, notification and referral to the health facilities. Outcome measures/variables: This will be a quasi-experimental pre-post design study and evaluation will be done through comparing antenatal care (ANC), postnatal care (PNC), and contraceptive prevalence rate (CPR) and EPI coverage before and after its implementation in the study versus comparison areas. The study will be conducted over a period of 30 months.