There are about 615 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.
To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome
Background: Chronic kidney disease (CKD) is a global public health concern. Currently 10-16% adults are affected with CKD. Adult individuals from low- and middle-income countries are at higher risk of developing CKD and End stage renal disease (ESRD). Preventive and risk reduction measures have potentials to reduce the disease progression; however, population in general from developing countries are yet to be properly aware about all these strategies that may help reduction in progression of CKD. Knowledge gap: Specific studies are grossly lacking about CKD prevalence, its associated factors, and the knowledge and awareness about preventive and risk reduction strategies among adults with CKD in rural and peri-urban Bangladesh. Moreover, knowledge gaps still exist about the role of Protein Energy Wasting (PEW), physical activities, medication adherence, dietary practice, salt restriction behaviours, etc. in influencing progression of CKD. Relevance: It has become essential to know more about the burden of CKD, its associated factors, current knowledge and awareness about healthy practices related to CKD and formulation of appropriate preventive and risk reduction strategies that will have potentials in reducing the progression of CKD in rural and peri-urban Bangladesh. The health education program for population in general and CKD individuals in particular will help in achieving meaningful results. Hypothesis:Health education about CKD and its preventive and risk reduction strategies will enhance the knowledge, awareness, and motivation for healthy practices among the residents of demographic surveillance system (DSS) area with CKD. Objectives: To implement and evaluate impact of a health education program in order to enhance knowledge, awareness, and motivation about healthy practices among rural adults suffering from CKD. Methods: A community based randomized controlled effectiveness trial (RCT) Study site: DSS area of Mirzapur sub-district under Tangail, Bangladesh. Outcome measures: Primary outcomes: Changes of scores of Australian CKD knowledge questionnaire Secondary outcomes: Awareness, Quality of life (QOL), and healthy practices leading to maintenance of blood pressure, blood sugar and body weight within normal ranges by the adult CKD individuals.
Asthma-COPD overlap (ACO) is a new entity in the world of respiratory ailments. The respiratory tract of these patients are continuously exposed to oxidants (due to cigarette smoking) causing oxidative stress. Antioxidant enzymes such as, superoxide dismutase (SOD) and catalase (CAT) neutralize these oxidants or free radicals and transform them into safer. Vitamin D is a natural antioxidant which has few evidence of increasing antioxidant enzyme level in COPD and asthma, but not in ACO patients. To evaluate the effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient patients with stable ACO. The randomized controlled trial was conducted in Department of Physiology Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from March 2018 to February 2019. For this study, a total number of 40 vitamin D3 deficient (serum 25 hydroxycholecalceferol <30 ng/ml) male, stable (diagnosed patient, who was not experienced any acute exacerbation, hospitalization, urgent care visits or changes in routine medication within 4 weeks prior to study) patients with ACO of age ≥40 years was selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and randomly grouped as A (control) and B (study). Then serum Superoxide dismutase and Catalase level of all the patients was assessed. Along with the standard pharmacological treatment of ACO (according to GOLD criteria), oral vitamin D3 (80,000 IU per week) will be supplied to the patients of the 'Study group' and placebo for 'Control group' for consecutive 26 weeks. At 26th week of follow up, all the study variables were examined. With this, all patients of both the groups were advised to continue ad lib (according to their own choice) diet. The results was expressed as mean±SD and the data was statistically analyzed by SPSS Version 16, using Independent sample 't' test (between two groups) and paired student's 't' test (between paired groups before and after intervention). In the interpretation of results, <0.05 level of probability (p) was accepted as significant.
This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.
We designed a double-blind, community-based, cluster-randomized control trial which will test to establish novel evidence on the efficacy of iron-fortified lentil in improving body Fe status of non-pregnant adolescents in rural Mymensingh district of Bangladesh. Lentils will be fortified with iron in the lab setting at the Crop Development Center (CDC) of the University of Saskatchewan in Canada. There will be three lentils based dietary intervention arm in this efficacy trial. Arm 1 will be intervened with iron-fortified lentils, Arm 2 will be non-iron fortified lentils, and Arm 3 arm will be the usual intake of lentil (no additional lentil). Arm 2 will be served as a comparison group and arm 3 will be served as control group. A total of 420 adolescent girls (including 20% drop-outs) - aged 10 - 17y; non-smoking, not pregnant, not breastfeeding, and generally healthy will be included in each arm - a total of 1260 adolescent girls in all three arms. Participating adolescents will be served thick preparation of cooked lentils (37.5gm raw lentil) 5 days a week for 85 feeding days (around 4+months). Socio-demographic characteristics, household food security status, and adolescent food habits will be collected at baseline and endline data point. Furthermore, venous blood will be collected to measure adolescents' Fe status at baseline, midline, and endline for 85 feeding days (5 days a week)- approx. 4+ months. In addition, Ravens Progressive Matrices will be used for non-verbal measurement of the cognitive ability of advanced observation and thinking skills specific to capacity for analyzing and solving problems, abstract reasoning, and the ability to learn of the adolescents. Both descriptive and inferential statistics will be used for this study. Serum ferritin level and cognitive performance is the primary outcome. The trial expects that the supplemental Fe from the iron-fortified lentils will improve body Fe status and cognitive performance after controlling for baseline Fe status and dietary Fe intake in this group of adolescent girls. The secondary outcome is the participants' anthropometries. Considering the amount of plant protein from lentils that need to be consumed to for the study, it is expected to have significant improvement in growth of the participants which will lead to increased productivity.
The CHAIN Network aims to identify modifiable biomedical and social factors driving the greatly increased risk of mortality among young undernourished children admitted to hospital with acute illness, as inpatients and after discharge. The study will inform priorities, risks and targeting for multi-faceted interventional trials. CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological samples. Study sites are located in Africa and South Asia. Children will be recruited at admission to hospital, stratified by nutritional status. Exposures will be assessed at admission, during hospitalisation, at discharge, and at two time points after discharge. The main outcomes of interest are mortality, re-admission to hospital and failure of nutritional recovery up to 180 days after discharge. To determine community health norms, an additional sample of children living in the same communities will be enrolled and assessed at one time point only.
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.
Background (brief): 1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. 2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported information, recommended by the World Health Organization for estimating gestational age but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. 3. Relevance: The goal of this study is to improve maternal and newborn outcomes by increasing the accuracy of gestational age estimation, using menstrual based dating, that is vital for providing timely and necessary obstetric and newborn care interventions. The study will determine the efficacy of three community based interventions using e-platform targeted to improve the recall and reporting of the date of last menstrual period in a rural resource poor setting. The innovative e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where e-Health and m-Health initiatives are proliferating with active support from all sectors in policy and implementation. Hypothesis : 1. Implementation of conventional and e-platform based interventions will lead to a 30% improvement in recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. 2. Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation. Objectives: The main objectives of the study are to: 1. Determine whether a set of conventional and e-platform based interventions improve recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. 2. Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three conventional and e-platform based interventions is proposed to improve recall of GA with a control arm. The trial will be conducted among adolescent girls and recently married women (within past two years) with no children or a single child in Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for recording date of LMP (ii) education and SMS based system for recording dates of LMP and reminders using mobile phone (normal) (iii) education and smart-phone based application for recording dates of LMP with an inbuilt reminder system. Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall of LMP date among enrolled participants in the three different intervention compared to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared to USG, following the intervention.
The purpose of this study is to investigate the incidence of Cryptosporidiosis in Bangladeshi children and describe the acquired immune response to the pathogen as well investigate the potential of human genetic susceptibility.