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NCT ID: NCT05644184 Recruiting - Poliomyelitis Clinical Trials

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Start date: March 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (336 subjects), and neonates (1155 subjects).

NCT ID: NCT05629624 Recruiting - Malnutrition, Child Clinical Trials

Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

NCT ID: NCT05590260 Recruiting - Postpartum Anemia Clinical Trials

Prevention of Iron Deficiency Anemia Post-delivery

PRIORITY
Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth. A total of 4,800 eligible women, or 600 women per research site, will be consented and enrolled in the trial. The study hypothesizes that at 6 weeks post-delivery, prevalence of the non-anemic state in women in that received a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility will be greater than that of women given a supply of oral iron tablets taken twice daily for 6 weeks.

NCT ID: NCT05576207 Recruiting - Preterm Birth Clinical Trials

BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)

Target-BEP
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low prepregnancy BMI or low prepregnancy BMI and inadequate gestational weight gain) on birth weight and adverse birth outcomes of low birth weight (LBW < 2500 g) and small-for-gestational age (SGA). To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms The main question[s] it aims to answer are: • Does mean birth weight and rate of LBW and SGA differ among mothers randomized to four arms that include targeted or untargeted BEP supplementation vs. MMS differ. Participants will be recruited in early pregnancy and be enrolled in the trial and randomly receive: 1. A daily BEP supplement from enrollment until birth 2. A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement 3. A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement or get switched to a BEP supplement based on inadequate gestational weight gain. Researchers will compare the above groups to women receiving a MMS daily to see if birth weight is higher in the intervention arms. Other adverse outcomes such as low birth weight, small-for-gestational age and preterm birth will also be compared between groups and relative to the control.

NCT ID: NCT05570552 Recruiting - Immune Function Clinical Trials

1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh

GEOHealth-II
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment. In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.

NCT ID: NCT05521763 Recruiting - Influenza Vaccines Clinical Trials

Influenza Vaccine Uptake Among Healthcare Workers

Start date: March 12, 2022
Phase: N/A
Study type: Interventional

Background: 1. Burden: Health-care workers (HCWs), such as doctors, nurses, and support staff involved in direct or indirect patient care, are at increased risk of influenza virus infections. HCWs may also transmit and spread influenza among hospitalized patients and other caregivers. HCWs often (40-83%) work while experiencing influenza-like illness (ILI), increasing the likelihood of influenza transmission to colleagues and patients. 2. Knowledge gap: Despite the World Health Organization recommendation for seasonal influenza vaccination among priority target groups such as health care workers, the low-income country such as Bangladesh lacks a seasonal influenza vaccination policy among this high-risk group, and vaccine uptake remains low. 3. Relevance: This study aims to generate preliminary data on HCWs willingness to get seasonal influenza vaccines following vaccine availability and factors associated with vaccine uptakes. The data from the study will support policymakers to increase awareness and develop influenza vaccination policy among top priority groups such as health care workers. Hypothesis: The investigators hypothesize that awareness and availability of influenza vaccine supply would increase influenza vaccine uptake among health care workers Objectives: 1. To assess influenza vaccine uptake among healthcare workers (HCWs) following awareness and availability of influenza vaccine supply in study hospitals 2. To explore HCWs barriers and Motivators for influenza vaccine uptake 3. To understand policy makers' perspectives on the feasibility of influenza vaccination among HCWs and to share with the National Immunization Technical Advisory Group (NITAG) for a policy decision regarding influenza vaccination Methods: The study will be conducted at four tertiary-level public teaching hospitals in Bangladesh. The investigators will use a cluster randomized controlled trial design. The intervention will be randomly allocated at the facility level and will include four arms: i) availability of influenza vaccine supply; ii) influenza vaccine awareness; iii) both influenza vaccine supply and influenza vaccine awareness, and iv) control arm with no intervention. The investigators will assess influenza vaccine uptake before and after intervention and between different study arms. The investigators will also explore the barriers and motivators of vaccine uptake using a qualitative approach. To understand the policy makers' perspectives and opinions regarding influenza vaccination among health care workers, the investigators will conduct in-depth interviews. Outcome measures/variables: 1. The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms 2. Different motivators and barriers to influenza vaccine uptake

NCT ID: NCT05520034 Recruiting - Stroke Clinical Trials

Reduction of Recurrence of Stroke by Nurse-led Education in Bangladesh

Start date: October 2, 2022
Phase: N/A
Study type: Interventional

Stroke is a major public issue that can be occurred a patient with severe and unbearable disability for a long time. Recurrence of stroke is increasing due to a lack of knowledge and compliance with treatment regarding the modifiable risk factors of stroke and behavioral and lifestyle changes. Nurse-led health education with (self) monitoring of modifiable risk factors and behaviors can be an effective way to create knowledge about the behavioral changes in stroke patients. The investigators hypothesized that health education among first stroke patients and their family caregivers could reduce the stroke recurrence rate by controlling modifiable risk factors compared to the first stroke patients without health education.

NCT ID: NCT05510687 Recruiting - Presbyopia Clinical Trials

Transforming Households With Refraction and Innovative Financial Technology

THRIFT
Start date: December 10, 2023
Phase: N/A
Study type: Interventional

The aim of the proposed Randomised Clinical Trial (RCT) is to assess the impact of presbyopia correction and basic digital financial training on greater adoption and use of digital financial services (primary outcome) and other welfare impacts (secondary outcomes)) for safety-net beneficiaries in Bagladesh. Trial participants will be Old Age Allowance (OAA) and Widows Allowance (WA) beneficiaries who regularly receive payments as part of a government safety net program for the very poor. The primary objective of the THRIFT trial is to assess whether the combined complementary intervention of providing free eyeglasses and basic digital financial services training in the use of mobile phones and the THRIFT app (a module locally developed to capture digital financial transactions) to recipients of government OAA and WA safety-net payments can lead to greater financial inclusion and improved quality of life. THRIFT's primary outcome is the adoption and effective use of the DFS platform in receiving digital OAA and WA transfers using the mobile banking platform, as measured by the difference between the treatment and control groups. The secondary outcomes analysed under the THRIFT trial will be: Total mobile data consumption by the individual Whether use of the application was facilitated by a bKash agent or family member, or independently by the beneficiary Purchase of additional phones by study participant's household Purchase of additional phones by study participant Intra-household resource sharing by the beneficiary (as a percentage of total household consumption) Purchase of glasses other than those issued to the intervention group. Food security (measured using standard module developed by World Food Programme (WFP) Role of study participant in household decision making Subjective well-being of study participants Mobility of study participant Social connectedness of study participant External remittances, recorded on the bKash app and captured in survey Self-reported incidence of theft or fraudulent use of money from the index participant's account.

NCT ID: NCT05500690 Recruiting - Clinical trials for Environmental Exposure

Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies

Start date: October 8, 2023
Phase: N/A
Study type: Interventional

Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure. In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.

NCT ID: NCT05492019 Recruiting - Parkinson Disease Clinical Trials

Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a Randomized, Double-Blind, Placebo-Controlled Trial. The objective of the study is to assess the effect of doxycycline in levodopa treated Parkinson's disease patients regarding motor performance and cognitive functions. Parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. The motor and cognitive symptoms of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.