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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.

NCT ID: NCT06101147 Recruiting - PCOS Clinical Trials

Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome

Start date: September 21, 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 low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.

NCT ID: NCT06088316 Recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy of Amoxicillin-Esomeprazole HDDT Compared to Levofloxacin Triple Therapy for H. Pylori Eradication: A RCT

Start date: February 10, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is - 1. To identify the percentage of H. pylori infection among dyspeptic patients 2. To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori. Participants will be screened on the basis of two different test (stool antigen test & endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin & esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin & esomeprazole for 14 days in usual dose. Dyspeptic symptoms will be recorded before & after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.

NCT ID: NCT06084429 Recruiting - Health Literacy Clinical Trials

Developing School Health Champions to Increase Health Literacy Both in School Adolescents and Community People Through Providing Health Education by the School Nurses in Bangladesh: Community-based Pre- and Post-experimental Design

Start date: February 24, 2024
Phase: N/A
Study type: Interventional

Health literacy is a person's decision-making ability to improve their quality of life and prevent diseases by accessing, understanding and applying health information. Health literacy in the adolescent's period can aid them to gain and understand health information which can bring positive health outcomes. The aim of this pilot study is to examine the efficacy of health education and school health activities provided by school nurses on improving health literacy among secondary school adolescents. The study will also examine whether health education by health champions (the adolescents) is effective in improving the health literacy of the community people, and examine whether these interventions develop awareness, improve health knowledge, empower, and change behaviors of secondary school adolescents. This intervention study aims to improve health literacy in the adolescents in Bangladesh and the school-located community. The Begum Ayesha Pilot Girl's High School in Dohar, Dhaka district will be selected as a field. First, we will place school nurses at the school, provide health checkups for both the adolescents (about n=316) and community people (about n=200), and school nurses will provide weekly health education for 3 months to the adolescents. After certifying them as "Health Champions", the health champions visit the community and provide health education activities to the community people. For both participant groups, health literacy will be measured as efficacy checking of this pilot study. Assent and informed consent will be obtained from the participants. Autonomy, beneficence, non-maleficence, fidelity, veracity, confidentiality, and justice of the participants will be ensured. Also, anonymity will be maintained across all stages of the study.

NCT ID: NCT06081114 Recruiting - Clinical trials for Micronutrient Status

Micronutrient Dose Response Study in Bangladesh

MiNDR
Start date: October 22, 2023
Phase: N/A
Study type: Interventional

The recommended daily amounts of vitamins and minerals, referred to as micronutrients, are based on data from high income settings and for healthy populations do not fully correct nutritional deficiencies in undernourished settings. This study will determine the minimum acceptable doses across a range of nutrients at which sufficiency is achieved with supplementation using biochemical indicators of nutritional status in non-pregnant (non-lactating) women of reproductive age and pregnant women in Bangladesh. In this double-masked randomized controlled trial, a dose response study will be undertaken using increasing levels of doses provided as supplements to women (pregnant or non-pregnant) with nutritional indicators as outcomes.

NCT ID: NCT06071481 Recruiting - Dengue Fever Clinical Trials

Role of Vitamin D in Prevention of Dengue Haemorrhagic Fever and Dengue Shock Syndrome

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

Dengue is an arthropod-borne disease, found in tropical and sub-tropical climates worldwide, mostly in urban and semi-urban areas. Unfortunately, there is no intervention available to stop dengue severity. Despite significant efforts into developing vaccine and antiviral drug for dengue fever over the years, numerous challenges remain before an efficient, safe vaccine and antiviral drug. Dengue Haemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS) are a serious form of dengue infection that can escalate in a non-negligible percentage of febrile patients. Factors responsible for this deterioration are weakly understood. The host's genetics and secondary infections from novel dengue serotypes are obvious risk factors. The dietary state of the host has also been emphasized as a potentially important predictor of progression because some nutrients have potent immunomodulatory effects. Vitamin D is particularly important as it has ability to control immunological processes, including the downregulation of pro-inflammatory Th1 activity, which has been linked to the pathophysiology of severe dengue. There is a preliminary study regarding the effectiveness of vitamin D in the prevention of DHF and DSS in human. But a larger study is needed to prove its utility. The objective of the study is to determine the role of Vitamin D in efficacy, safety and dose response in the prevention of DHF and DSS. This will be an open-label Phase-2 Randomized controlled trial (RCT) which will be carried out in Dengue cell, Emergency Department and Outpatient Department (OPD) of Medicine Department in Bangabandhu Sheikh Mujib Medical University, Dhaka. It will be conducted from September 2023 to August 2024 enrolling about 120 patients from Dengue cell, Emergency Department and OPD of Medicine Department BSMMU. The duration of the study will be one year. All the investigations will be done in BSMMU. Patients will be followed up by phone call and physical visit. Those with severe symptoms will be admitted and evaluated accordingly. The study will have three arms namely, Arm 1(receiving standard care), Arm 2(receiving standard care and 2,00,000 IU Vitamin D oral solution) and Arm 3(receiving standard treatment and 4,00,000 IU Vitamin D oral solution). The patients will be enrolled according to inclusion criteria (having age more than 18 to 65years, NS1 positive, fever more than ≥38°C for 3days or less, typical sign symptoms of Dengue fever) and exclusion criteria (>72hours of fever, critically ill patients, pregnancy, known Vitamin D hypersensitivity, high serum calcium level, hypoalbuminaemia, malignancy, known nephrolithiasis and severe renal impairment). Information will be obtained on socio-demographic and clinical characteristics through face to face interview using a structured questionnaire. Clinical data and relevant blood samples will be taken at first appointment then after 4th day and 8th day of enrollment. This study has minimal chance of physical risks. Study purpose will be explained to the participants and informed written consent will be taken before collection of data. Data will be collected with assurance of proper safety and privacy. The interventional drug, vitamin D3 is a widely used agent with rare minimal side effects like, vomiting, abdominal pain, headache, constipation etc. Each participant will be counselled about the outcome of the drug and will be followed up and managed for potential side effects. Participants will be identified by a code number, strict confidentiality and anonymity will be maintained. There will be no loss of work time and no compensation will be available for the participants as this will be a part of standard care. On the other hand, this study would be helpful for both the clinician and the patients in making a rational approach in Group A Dengue fever for the prevention of DHF and DSS. Prior to the commencement of this study, the research protocol will take approval from Research and Training Monitoring Department(RTMD) of BCPS. The analyzed data will be presented in the form of text, tables, and graphs. Finally collected data will be analyzed by graph pad prism. Statistical analysis will be performed by Chi-square test on categorical data and one way ANOVA with Tukey's multiple comparisons test on continuous data. Kaplan-Meier Curve will be used to study the progression into DHF and DSS. This study, for the first time in Bangladesh, will obtain the baseline data regarding the utility of Vitamin D therapy in Dengue uncomplicated cases in preventing further deterioration of clinical severity and mortality. This trial will help clinicians and policy makers to avail a possible repurposing of Vitamin D for prevention of severe dengue. In addition, it will guide designing larger study to generate strong evidence and change the national health response accordingly.

NCT ID: NCT06051344 Recruiting - Clinical trials for Primary Osteoarthritis

Effect of Zoledronic Acid in Primary Knee Osteoarthritis

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

We try to find out the effect of zoledronic acid over pain of primary knee osteoarthritis and also functional status in a period of 6 months.