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NCT ID: NCT05680805 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS

Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is to see the associations of metabolic responses of metformin with single nucleotide polymorphisms (SNPs) (rs628031 and rs2282143) of solute carrier family 22 member 1 (SLC22A1) gene in women with polycystic ovary syndrome (PCOS). This prospective clinical study will be conducted in the department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU) from February 2023 to September 2024 over a period of two years. A total of at least 100 women with PCOS (18 - 35 years) diagnosed based on International Evidence-based Guideline for PCOS 2018, will be included consecutively by convenient sampling. After taking informed written consent, relevant clinical history will be taken and physical examinations will be done at baseline. Following a run in phase of three weeks, patients will visit thrice after 1, 12 & 24 weeks of metformin maintenance therapy with a window period of 14 days both ways. Blood samples will be collected in fasting state at baseline and after 24 weeks of treatment to measure glycemic status, lipid profile, fasting insulin, c-peptide and detection of SLC22A1 gene (rs628031 and rs2282143) polymorphisms. Glucose will be measured by glucose oxidase method, lipids by glycerol phosphate dehydrogenase peroxidase method, insulin by chemiluminescent microparticle immunoassay, c-peptide by enzyme-linked immunosorbent assay (ELISA) and genetic analysis of rs628031 and rs2282143 by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).

NCT ID: NCT05668078 Completed - School Absenteeism Clinical Trials

Effectiveness of Rapid Antigen Testing of Students for COVID-19 in Reducing Absences From Schools in Bangladesh

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

The goal of this trial is to evaluate the impact of different testing strategies with Rapid Antigen Testing (RAT) on reduction of school absences. RATs are relatively inexpensive, fast, and can be performed at the point of care. Provision of testing in schools will allow rapid identification and isolation of individuals infected with Covid-19. This will likely reduce COVID-19 transmission, as well as allow symptomatic COVID-19 negative students to return to classroom, avoiding the 10-days isolation period. If proven successful, the lessons from this study can be translated to schools in similar settings. While several testing strategies have been proposed and evaluated in developed countries, no studies have evaluated the role of testing for safe operation of schools or reducing absenteeism in developing country contexts.The lessons learned from this study is likely to inform government policy regarding the provision of testing in school. Study design: Cluster randomized trial School types: Three types based on testing: - Intervention school-1: Test all symptomatic students, teachers, and support staff ; and track symptoms and absenteeism - Intervention school-2: Test all students, teachers, and support staff every 3 days, irrespective of symptoms (also test whenever develops symptoms) and track symptoms and absenteeism - Control school: Only track the students for symptom notification and absenteeism

NCT ID: NCT05660655 Recruiting - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.

NCT ID: NCT05644184 Not yet recruiting - Poliomyelitis Clinical Trials

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Start date: February 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: NCT05640297 Enrolling by invitation - Weight Gain Clinical Trials

"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.

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: NCT05614089 Not yet recruiting - Type 1 Diabetes Clinical Trials

Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

Start date: January 2023
Phase: Phase 4
Study type: Interventional

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

NCT ID: NCT05608928 Not yet recruiting - Clinical trials for Environmental Enteropathy

Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia

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

This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale phase 2 trial in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT05590260 Not yet recruiting - Postpartum Anemia Clinical Trials

Prevention of Iron Deficiency Anemia Post-delivery

Start date: January 1, 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: NCT05585658 Completed - Clinical trials for Natural Blood and Blood Product Toxicity

A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002

Start date: October 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Erythropoietin (EPO) biosimilarity for GBPD002 (test candidate) and Eprex® (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection in human subjects. This was a randomized, double-blind, two-sequence, crossover study. Subjects were randomly assigned and received a dose (4,000 IU) of either the test or comparator EPO. The subjects received the alternative formulation after the wash out period (4 weeks) of the first administration. The primary PK parameters, viz., maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUC00-inf), were calculated with the serum EPO concentrations from blood samples and were found comparable for both formulations. The geometric mean ratios (@90% CI) of the Cmax and AUCinf were 1.16 and 0.89, respectively, which were within the regulatory range of 0.80-1.25. The reticulocyte, hematocrit, hemoglobin and red blood cell counts were measured as PD markers. The time-matched serum EPO concentrations and PD markers denoted a counterclockwise hysteresis, and thereby suggesting a time delay between the observed concentration and the response. ANOVA derived P-values (all were greater than 0.05) for the effectors clearly revealed the similarity between effects on PD markers for both formulations. Both formulations were found tolerated well, and anti-drug antibodies were not observed. Thus, the two formulations are projected to be used interchangeably in clinical settings.