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NCT ID: NCT05127434 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Start date: November 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

NCT ID: NCT05072132 Active, not recruiting - Arsenic Exposure Clinical Trials

Returning Genetic Results on Arsenic Susceptibility

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

In recent years, returning genetic results to research participants has become a topic of debate, with a growing consensus that researchers should offer to return incidental findings and research results to participants. Currently, the research and debates surrounding return of results (ROR) have primarily taken place in high-income countries. Less attention has been paid to ROR in lower-resource countries. However, research participants in these settings may have additional threats, barriers, and/or competing interests that reduce the benefit or relevance of receiving genetic results. Arsenic is a toxic metal. Exposure to arsenic increases a person's risk for cancer, especially in the lung, kidney, bladder and skin. Many people in Bangladesh are exposed to elevated environmental levels of arsenic through naturally contaminated drinking water. People who metabolize arsenic (remove it from their body) slower compared to people who metabolize arsenic more efficiently are at higher risk for arsenic toxicities (e.g. cancer). The investigators have designed a study in which they plan to enroll individuals who have had consistently high urine As levels (≥200 µg/g creatinine) based on 15-20 years of follow-up data. The treatment and control groups will be selected based on genotype (i.e. inefficient and efficient As metabolizers, respectively), allowing for the selection of the groups to be quasi-random (based on inherited genotypes). A standard informational intervention will be provided to both the treatment and controls groups, reminding them of the effects of As exposure and strategies to reduce their exposure. The research question is whether the treatment group will, have a larger decrease in urine arsenic levels compared to the control group, indicating that the ROR intervention caused a change in water-seeking behavior leading to lower arsenic exposure.

NCT ID: NCT04998344 Active, not recruiting - Clinical trials for Influenza Viral Infections

An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh

FluEffect
Start date: April 7, 2021
Phase: Phase 4
Study type: Interventional

Annually influenza is a leading cause of severe disease and mortality particularly in young children <5 years old and pregnant women in the low and middle-income countries (LMICs) and both groups are prioritised for vaccination by the World Health Organisation (WHO). In Bangladesh, influenza is responsible for 10% of all childhood pneumonias and 9% of all death. Maternal influenza is associated with an increased risk of hospitalisation and foetal malformation. Influenza is a vaccine preventable disease, however, in most LMICs influenza vaccination is not part of the vaccination programme. This study will evaluate the effectiveness of inactivated influenza vaccine against influenza illness among pregnant women and children in Bangladesh. Influenza vaccine has not yet been studied as combined immunization strategy in a cluster randomized trial. This study is a community-based randomised trial in both pregnant women and young children to assess the impact of inactivated influenza vaccine in preventing influenza in the community as well as population level impact by both direct and indirect effect of vaccination.

NCT ID: NCT04868669 Active, not recruiting - Clinical trials for Gestational Weight Gain

Improving Maternal Nutrition in Matlab

IMNiM
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

Background: Maternal undernutrition and inadequate gestational weight gain (GWG) are prevalent in rural communities of low- and middle-income countries (LMICs). In Matlab, Bangladesh, 54% of the women fail to gain adequate weight (>4 kg) in the third trimester. Risks associated with inadequate GWG include giving birth to a small-for-gestational age (SGA) infant, low birth weight (LBW) infant, preterm birth (PTB), etc. Few contemporary studies examined the efficacy of nutrition counseling on GWG improvement in LMICs. Objectives: The primary objective of this study is to assess whether in-home, intensive nutrition counseling during pregnancy, compared to standard antenatal care, could improve GWG among pregnant women in rural Bangladesh. Methods: This prospective, two-arm, parallel group, equal allocation, open-label, community-based, cluster-randomized controlled trial will be conducted in the icddr,b service area of Matlab, a rural subdistrict of Bangladesh. Clusters will be randomly allocated 1:1 to the intervention arm in which pregnant women will receive monthly in-home, intensive nutrition counseling or the control arm in which pregnant women will receive standard antenatal care as offered by icddr,b and Govt. facilities. Fixed Site Clinics (FSCs) located at the homes of the community health research workers (CHRWs) will act as clusters. Of the 33 FSCs serving rural areas in the icddr,b service area, 20 will be selected randomly and listed. These 20 clinics will then be randomly allocated 1:1 to either an intervention or control group using a computer-generated random allocation sequence. To fulfil the required sample size, each selected CHRW will enroll 16 consecutive pregnancies. Required sample size is 16 women per cluster i.e. 160 women per arm. Eligible participants will be enrolled upon obtaining their consent by 13 and 6/7 weeks of gestation (first trimester) and followed up to 6 weeks postpartum. Trained health workers will visit the homes of the women in the intervention arm once a month and provide nutrition counseling to the women and her influential family members such as mothers, mothers-in-law and husbands. Both intention-to-treat and per-protocol analyses will be performed. Outcome measures/variables: Proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to the US Institute of Medicine (IOM) 2009 guidelines is the primary outcome variable.

NCT ID: NCT04758169 Active, not recruiting - Health Behavior Clinical Trials

Exploring Enhanced HFP to Reduce Child Marriage in Bangladesh

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Child marriage leads to pregnancy in adolescence, a root cause of both malnutrition and the intergenerational cycle of malnutrition. Two-thirds of Bangladeshi girls are married before 18 years, nearly half become pregnant before 19, and the rates of stunting and underweight are 26% and 36%, respectively. There are well-established risks of adolescent pregnancy for both mother (impaired growth and development due to nutrient reallocation for pregnancy and lactation), and infants (increased risk of low birth weight and small-for-gestational-age). Poor sexual and reproductive health (SRH), infant and young child feeding (IYCF), and water, sanitation, and hygiene (WASH) knowledge could impair the nutritional and health status of the whole family, sparking intergenerational issues. The investigators propose to investigate the efficacy of a gender-transformative enhanced homestead food production (EHFP) program to prevent child marriage, and in turn, adolescent pregnancy-induced malnutrition among girls aged 13-15 years in a high-risk area for child marriage, Khulna Division, southern Bangladesh. The investigators will conduct a cluster-randomized controlled trial in which n=1200 girls in after-school Adolescent Clubs will participate in a 24-month program teaching women's empowerment through hands-on workshops. All participants (control and EHFP groups) will be exposed to SRH, WASH, and IYCF, while those in the EHFP group will also receive EFHP training and inputs intended to improve nutrient intake and provide an income source for the adolescent girls' family. Investigators hypothesize that girls in the EHFP group will have lower rates of marriage and pregnancy, and improved food security, dietary diversity, nutritional status, IYCF, WASH, and SRH knowledge/practices.

NCT ID: NCT04753645 Active, not recruiting - Clinical trials for Hygiene Practices and Knowledge

BRAC Institute of Governance and Development-Hygiene Behavioural Change and Coalition

(BIGD-HBCC)
Start date: September 19, 2020
Phase: N/A
Study type: Interventional

In line with BRAC's overall goals to limit the COVID19 transmission, BRAC has constructed 1,000 handwashing stations coupled with other supports i.e. in-person demonstration, hygiene meetings, and soap distribution in Bangladesh. The purpose of this study is to assess the impact of public handwashing stations (HWSs) on people's hygiene behavior and health outcomes in response to the COVID-19 situation. For this, at the household level, we will collect information on self-reported handwashing practices, income, health status, and HWSs along with other relevant socio-demographic variables in detail. In addition, we will observe people's mobility, mask usage at public places, and the HWSs usage; and will associate the observed HWSs usage with their self-reported health outcomes. This study will conduct surveys on households (7,760) and public (5,820) in 20 sub-districts of Mymensingh, Khulna, and Dhaka divisions. Overall, this study is expected to directly benefit study participants and their communities by unveiling new evidence to inform BRAC's existing hygiene behavioral change programming in these communities. In addition, this information will yield future societal benefits by generating evidence on how to effectively implement and disseminate infrastructure and information that people can trust, believe, and use to form healthy hygiene habits.

NCT ID: NCT04736173 Active, not recruiting - Lung Cancer Clinical Trials

Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer

ARC-10
Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

NCT ID: NCT04693000 Active, not recruiting - Clinical trials for Keratotic Nodular Size

Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis

Start date: September 23, 2018
Phase: Phase 2
Study type: Interventional

Arsenic is one of the largest mass poisonings in Bangladesh. Arsenic keratosis of the palm and sole is a common feature of arsenicosis. Brinjal or eggplant ubiquitous vegetable found in different parts of the world, including Bangladesh, scientifically known as Solanum melongena. A study showed ointment containing crude extract of Solanum melongena peel origin is effective in arsenic keratosis. Solasodine is one of the active compounds of Solanum melongena peel. In the current study, an ointment containing a single compound solasodine isolated from Solanum melongena peel . The ointment made from solasodine extract was distributed among arsenic keratosis patients to see the effect.

NCT ID: NCT04542473 Active, not recruiting - SEPSIS Clinical Trials

Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

PB-SAM
Start date: July 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Children with severe malnutrition who are sick and admitted to hospitals have high mortality, usually because of infection. Malnourished children have more potentially harmful bacteria in their upper intestines than well-nourished children and this may contribute to inflammation in the gut and whole body. These bacteria may cross from the intestines to the bloodstream causing life-threatening infections. A related abnormality among malnourished children is reduction in the digestive enzymes made by the pancreas and the liver. Apart from helping with digestion of food, these enzymes are important in helping the body control bacteria in the upper intestines. It is therefore possible that treatment with digestive enzymes could help reduce the burden of harmful bacteria and thus lower inflammation and the risk of serious infection. One study conducted in Malawi has shown that children with severe malnutrition who were supplemented with pancreatic enzymes had a lower risk of dying. However, this was a small study and although promising, requires validation. No studies of supplementation with bile acids have been done among severely malnourished children. However, bile acids are commonly used to manage patients with liver function abnormalities, something that malnourished children suffer from as well. The investigators want to find out if supplementing these pancreatic enzymes and bile acids among ill children with severe acute malnutrition is safe and reduces the risk of death, deterioration or readmission to hospital.

NCT ID: NCT04464642 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Start date: July 10, 2019
Phase: Phase 4
Study type: Interventional

It is a randomized controlled study