There are about 620 clinical studies being (or have been) conducted in Bangladesh. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
As the global availability of vaccines increases, and reaches areas disproportionately affected by arsenic and malnutrition, resolving questions about potential environmental and biologic barriers to maternal immunization has become increasingly urgent. It is not known whether arsenic, a known developmental toxicant, can alter maternal immune responses to vaccination and whether exposure to arsenic during pregnancy can impair the transfer of maternal vaccine-induced antibody to the newborn. Moreover, factors known to affect arsenic metabolism and toxicity outcomes, particularly micronutrients critical in one-carbon metabolism, have not been evaluated in studies of arsenic immunotoxicity and vaccine-induced protection in mothers and their newborns. The objective in this study is to investigate whether maternal arsenic exposure and one-carbon metabolism micronutrient deficiencies alter maternal and newborn measures of vaccine-induced protection, respiratory morbidity, and systemic immune function following influenza vaccination during pregnancy.
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will: I. Collect baseline data on housing types and finalize windows/vents protoypes. II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh. III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design
The study will use a quasi-experimental design to examine the feasibility of standardizing MIYCN counseling services in existing health facilities to improve the quality of MIYCN services. The impact of standardized and upgraded services on client utilization, knowledge and behavior will also be measured. 8 NGO-run urban health facilities in Dhaka will receive intensified MIYCN interventions, while another 8 NGO-run urban health facilities will serve as a comparison group. No randomization will take place.
Vitamin D3 supplementation doen not change lung functions and exercise tolerance in vitamin D3 deficient ACO patient was the null hypothesis of the research.
Principal Investigator: Mohammod Jobayer Chisti Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial Proposed start date: 1st July 2018, Estimated end date: 31st December 2022 Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale. Objectives: Stages I and II - To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II - To record adverse events following use of bubble CPAP in these settings - To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system Stage III: - To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia - To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure & mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia - To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.
This study will be conducted upon the patients with fatty liver disease. Patients who will be diagnosed as a case of fatty liver disease by ultrasound with raised liver enzyme (ALT) will be primarily selected for the study. A total number of 70 patients will be randomly selected for the study that will also be divided into two groups for the study purpose. The patients will be informed about the details of the study. After getting the detail information those who will give informed written consent will be finally included in the study. One group of patients will be treated by both life style modification and Obeticholic acid. Another group of patients by only life style modification. After 3 months of treatment the two groups will be compared of improvement of fatty liver disease and liver enzyme by improvement of fibroscan with CAP value as well as improvement of ALT value.
Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. A total of 40 infants (9-18 mo of age) will participate in this study. Investigators will use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). The investigators will also use two different stable isotopic retinols for the assessment of total body vitamin A stores. Baseline blood samples (5 mL) will be obtained from all infants and then randomly selected 30 infants will receive PENTA vaccines, while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP and on the same day, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group. Thus estimated plasma micronutrients and vitamin A stores before and after inflammation will calculate the effects of inflammation on the interpretation of micronutrient deficiencies based on biochemical indicator assessment.
Background: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality throughout the world which is a preventable as well as treatable disease. It has some important extra pulmonary effects which may contribute to the magnitude of the severity of this disease. Standard therapeutic treatment alone does not optimize its remedy. Vitamin D3 has been found to improve the physical efficiency of patients with various morbid disorders, including respiratory ailments. Hypothesis:Vitamin D3 administration in stable patients with moderate COPD improves lung function variables along with exercise tolerance. Objectives: To evaluate the effects of Vitamin D3 on lung functions and exercise tolerance in patients with stable moderate COPD. Methods: For this, a prospective interventional randomized double blinded study will be carried out on 46 vitamin D3 deficient (serum 25 dihidroxycholecalceferol less than 30 ng/ml), male, stable (diagnosed patient, who has not experienced any acute exacerbation , hospitalizations , urgent care visits, or changes in routine medication within 4 weeks prior to study), moderate (post bronchodilator FEV1/FVC<0.70 of predicted value and FEV1=50 to 79% of predicted value) COPD patients (age ≥40 years), who will be selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and will be grouped as A (control) and B (study) groups, respectively. All the patients will be again designated as A0, A90 (without D3) and B0, B90 (with D3) for before and after 90 days of follow up. All the participants will be matched in terms of duration of COPD, history of smoking, occupation and socioeconomic status. Along with the standard pharmacological treatment of COPD, the patients of the 'Study group' will be prescribed for 80000 IU of oral vitamin D3 pre week for consecutive 3 months. Along with this, all patients both the groups will be advised to continue ad lib (according to their own choice) diet. At the very 1st day of the study, the lung functions will be assessed by measuring Forced vital capacity (FVC), Forced expiratory volume in one second (FEV1), Forced expiratory ratio (FEV1/FVC%), Peak expiratory flow rate (PEFR) and Forced mid expiratory flow of FVC(FEF25-75%), with a portable digital spirometer. In addition, exercise tolerance will be assessed by change in 6 Minute Walk Distance (6MWD) in 6 Minute Walk Test (6MWT). Changes in peripheral capillary oxygen saturation (SpO2) by Pulse Oximeter and degree of dyspnoea by Modified Borg Scale (MBS) will also be measured both before and after 6MWT to evaluate their change in both the groups. All these variables will be measured again among same 46 patient after 90 days standard pharmacological treatment of COPD with D3 intervention (B group) and also without D3 intervention (A group). For statistical analysis, Chi-square test, independent sample 't' test between two groups, paired Student's 't' test within two specific measurements of different durations of each group ,will be done. In the interpretation of results, ≤0.05 level of probability (p) will be accepted as significant.
Title:Impact of vitamin D administration on cardiac autonomic tone in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap patients: A blinded randomized control trial. Background: Respiratory disease is closely associated with cardiovascular disease. Reduced Heart Rate Variability (HRV), reflecting impaired autonomic activity have been reported in both asthma and COPD. Vitamin D deficiency is a common feature in Asthma COPD Overlap (ACO) patient. Relationship between vitamin D deficiency and low HRV has been reported. Vitamin D administration has been reported to improve cardiac autonomic modulation in healthy subjects in response to external stressor. Objective: To assess the changes in cardiac autonomic tone after vitamin D administration for 90 days in vitamin D deficient ACO patients. Hypothesis:Null: Vitamin D administration does not have impact on cardiac autonomic tone in vitamin D3 deficient ACO patient. .Method: This randomized controlled trial will be conducted by Department of Physiology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from September' 2017 to August' 2018. For this study, a total number of 60 subjects (age > 40 years, both male and female) will be randomly selected. 30 diagnosed vitamin D deficient Asthma COPD Overlap (ACO) patients will form group A and another 30 diagnosed vitamin D3 deficient ACO patients with similar age, sex, (Body Mass Index) BMI will constitute control group B. Patients of study group B0 will take vitamin D3 with a prescribed schedule for 3 months and followed up after 3 months (group B90). On the other hand patients of group A1 will be given placebo and followed up after 3 months (group A90). All these patients will continue their medication prescribed by physician during these 3 months. On the basis of data recording - group B1 and group B90 will constitute pre and post vitamin D group whereas group A0 and group A90 will represent pre and post placebo follow up at day 0 and day 90. Cardiac autonomic nerve function will be assessed by recording ECG & Heart Rate Variability (HRV) analysis by a data acquisition device, powerlab 8/35, AD instruments, Australia. HRV measures of all patients will be recorded at baseline.Then after 3 months of follow up it will be recorded in both groups at day 90. Serum 25(OH)D level will be measured of all subject at day 0 and day 90. For statistical analysis unpaired and paired "t" test will be done by using Microsoft Office Excel Word version 2016