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NCT ID: NCT06222372 Recruiting - Leprosy Clinical Trials

Novel Interventions and Diagnostic Tests for Leprosy

INDIGO#2
Start date: March 4, 2020
Phase: N/A
Study type: Interventional

Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting. The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.

NCT ID: NCT06196450 Recruiting - Clinical trials for Environmental Enteric Dysfunction

Maternal Probiotic Intervention to Improve Gut Health

MPIGH
Start date: June 22, 2023
Phase: Phase 2
Study type: Interventional

This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate 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 trials in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT06193408 Recruiting - Cholera Clinical Trials

Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

Start date: February 11, 2024
Phase: Phase 2
Study type: Interventional

Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens

NCT ID: NCT06148142 Recruiting - Blood Pressure Clinical Trials

Effectiveness of a Community Pharmacy-based Health Promotion Program on Hypertension in Bangladesh and Pakistan

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The aim of this multi-country research project is to reduce the blood pressure of individuals with hypertension over a 12-month period in Bangladesh and Pakistan. A cluster randomized controlled trial (cRCT) will be conducted with two arms. The estimated sample size is around 3600 hypertensive adults. Bangladesh study participants will consist of 3600 hypertensive individuals. Approximately 10% of participants will be selected based on Bangladesh samples from Pakistan (360 hypertensive patients, four pharmacies). Community pharmacies will be randomised to one of two parallel groups (allocation ratio 1:1). Pharmacy professionals will provide educational training and counselling, as well as phone calls/mobile text messages and care coordination in the health sector as part of the intervention. The study will be conducted in three phases: baseline survey; intervention and follow-up; and endline survey with impact evaluation. The primary outcome will be BP reduction and the secondary outcomes will be BP controlled to target, treatment adherence, mortality or hospital admission rates resulting from hypertension and its related complications, incremental cost per quality-adjusted life year gained, improvement in knowledge on healthy lifestyle, change in dietary salt intake, and change in prevalence of current smokers.

NCT ID: NCT06126770 Recruiting - Clinical trials for Sexual and Reproductive Health and Rights

Development and Testing of Balika Bodhu

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

The study aims to generate knowledge on barriers experienced by married adolescent girls (MAGs) in demanding, accessing and practicing their rights regarding their sexual and reproductive health (SRH), including family planning (FP) use, conception, and seeking health care relating to SRH. We will also explore the underlying factors influencing such barriers. The study will develop and test a social norms intervention that addresses the gaps in programming and in the literature combining a comprehensive empowerment programme for MAGs with engagement of other stakeholders to increase demand, access and practices of positive behaviours in relation to sexual and reproductive health and rights (SRHR) among these girls. We will collaborate with a local organization, who usually work on empowerment and SRHR of women, for implementing the intervention and will build their capacity as well. The study will employ a mixed-method two-arm cluster randomized controlled trial design. All the information generated will inform the program and policy about the barriers and potential solutions to improve demand, access and practices of SRHR among the MAGs.

NCT ID: NCT06126029 Recruiting - Knee Osteoarthritis Clinical Trials

Effect of Metformin as Add-on Therapy to Ibuprofen on Disease Activity in Knee Osteoarthritis Patients.

Start date: October 15, 2023
Phase: Phase 2
Study type: Interventional

The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of metformin compared with placebo-controlled group on disease activity and interleukin-6 level in patients with knee osteoarthritis.The main question it aims to answer is:Is Metformin as add-on therapy more effective in reducing disease activity in Ibuprofen-treated patients with grade II-III knee osteoarthritis? Half of Participants will receive metformin with standard of care(ibuprofen and rabeprazole) while other half placebo and standard of care (ibuprofen and rabeprazole).

NCT ID: NCT06125782 Recruiting - Clinical trials for Autism Spectrum Disorder

Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial

Start date: September 19, 2023
Phase: Phase 2
Study type: Interventional

This study is conducted to assess whether Omega-3 fatty acid improves neurobehavioral staus of children with Autism Spectrum Disorder and whether there is any correlation of this improvement with reference range of Omega-3 fatty acid.

NCT ID: NCT06114407 Recruiting - Clinical trials for Spondyloarthritis, Axial

Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

Start date: October 30, 2023
Phase: Phase 2
Study type: Interventional

Axial Spondylarthritis (ax-SpA) is an important cause of inflammatory back pain in young adults. Janus kinase inhibitors (JAKi) has been approved for treatment of ax-SpA. Tofacitinib and baricitinib are drugs from same family (JAKi). Baricitinib is relatively less expensive than Tofacitinib. The goal of this non-inferiority clinical trial is to learn about the efficacy of baricitinib in refractory axial spondyloarthritis ( ax-SpA) and to compare its effect with that of tofacitinib. The main questions it aims to answer are: 1. Is baricitinib 4 mg effective in refractory ax-SpA? 2. Is baricitinib non-inferior to tofacitinib in refractory ax-SpA? Participants (treatment group, 92 patients) will be treated with baricitinib 2 mg twice daily for 12 weeks. Ninety two patients getting tofacitinib 10 mg/day (comparison group) will be taken as historical control from another study on the efficacy of tofacitinib in refractory ax-SpA?

NCT ID: NCT06111352 Recruiting - Clinical trials for Organophosphorus Poisoning

Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime

OPC
Start date: November 2023
Phase: Phase 2
Study type: Interventional

This open level randomized controlled trial will be conducted in the department of medicine at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history of organophosphorus poisoning within 24 hours with clinical features and physical evidence of poisoning consumed. Only moderate severity (POP Scale score 4-7) of OPC (Organophosphorus compound) patients will be included in this study. Then one group of patients will be treated with atropine and pralidoxime and another group will be treated with atropine. The outcome will be noted as clinical improvement or recovery. hospital stay, requirement of ICU, death.

NCT ID: NCT06103331 Recruiting - Clinical trials for Invasive Fungal Infections

Fungal Surveillance in Bangladesh

Start date: January 20, 2022
Phase:
Study type: Observational

This will be an exploratory descriptive study designed to conduct surveillance for the identification of invasive fungal pathogens among hospitalized patients in Bangladesh at two tertiary care acute-level hospitals. including the Dhaka Medical College Hospital, the Dhaka Hospital of icddr,b, and the National Institute of Cancer Research Hospital (NICRH). Respiratory samples, blood, urine, cerebrospinal fluid, surgical wound infection swabs, and other samples including biopsy tissue specimens will be obtained at intensive care units, general medicine and surgery wards, post-operative care, etc. The collected specimens will be sent to the clinical microbiology laboratories of the surveillance hospitals or to the pathology laboratory (biopsy tissue specimens) to test for Aspergillus, Histoplasms, Candida, Pneumocystis, Cryptococcus, and Mucormycetes. The lab. methods will include microscopy, staining, culture, and biochemical tests mainly and if feasible then some specimens may undergo molecular or immunological methods.