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.
COVID-19 or coronavirus disease 2019 is an emerging infectious disease. The disease was first identified in China and then spread worldwide; hence, declared as a global pandemic on March 11, 2020 by World Health Organization (WHO). The pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of. Rapidly accumulating clinical evidence on COVID-19 paved the way for an extensive and prompt characterization of the acute phase of the disease. The clinical presentation is generally that of a respiratory infection with a symptom severity ranging from a mild common cold-like illness, to a severe viral pneumonia leading to acute respiratory distress syndrome that is potentially fatal. Characteristic symptoms include fever, cough, and dyspnoea, although some patients may be asymptomatic. Complications of severe disease include, but are not limited to, multi-organ failure, septic shock, and acute respiratory distress syndrome. The COVID-19 infection fatality rate is between 0.5 and 1 percent and the remaining affected patients will mostly recover but need convalescent care. However, discharge should not be considered as the final point of overcoming coronavirus and till date evidence on sequelae of the COVID-19 recovered patients is very limited. COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, metabolic derangement; and nutritional status. The extent to which these alterations may persist remains obscure, till date evidence on long term sequelae of the COVID-19 recovered patients is very limited. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future. Long-term morbidities were observed in survivors of severe acute respiratory syndrome but it is unidentified whether experience from SARS is applicable to COVID-19. The SARS-CoV-2 infection is severe in older, immune deficient people and who have any pre-existing medical conditions. Hence, it is imperative to comprehend the possible long-term sequelae of the COVID-19 recovered patients, and if they will develop any other harmful illnesses. This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale. Objective: 1. To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial. 2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals. 3. To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia. 4. To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals. Methodology: Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP. Outcome: 1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP. 2. To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh. 3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes. 4. A qualitative assessment of the feasibility of introducing bubble CPAP. Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital) Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study. Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed. Study duration: 44 months
The primary objective is to determine, among dengue-naïve adults in an endemic population, the protective efficacy of TetraVax-DV TV005 vaccine against dengue infection induced by a live recombinant attenuated rDEN2∆30-7169 attenuated virus strain administered 6, 12, or 24 months after vaccination. Secondary objectives are: 1. Determine the durability of protection of TetraVax-DV TV005. 2. Evaluate the safety of TetraVax-DV TV005 in dengue-naïve volunteers in a dengue endemic population. 3. Evaluate the safety of the rDEN2∆30-7169 attenuated virus strain in a dengue endemic population.
The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. The study also examines if community-based activation through values or individual activation through information results in higher mask-wearing.
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.
The outbreak of the severe acute respiratory syndrome (SARS) corona virus (CoV)-2 continues to increase globally. To control the coronavirus disease 2019 (COVID-19) transmission, diagnose is very important step which would help in the process of quarantine, isolation of the infected person and also in contact tracing. Among the various techniques real-time reverse transcription polymerase chain reaction (rRT-PCR) is mostly used and considers as gold standard method for viral nucleic acid detection as per World Health Organization (WHO) and Centre for Diseases Control (CDC), USA. However, possible false-negative and false-positive results produce misleading consequences, making it necessary to improve existing methods. So, investigators need a robust and reliable PCR kit to detect different kinds of variant of SARS-CoV-2 virus to reduce its transmissibility and take preventive management plan. Beside that to manage the increasing number of testing, investigators are mostly dependent on imported test kit which seems to be very difficult at this pandemic situation and costly. Hence, virulence of SARS-CoV-2 virus may change rapidly due to mutation and country become hot spot so, gene detection RT-PCR kit is time demand. In this point of view, investigator's aim to develop an validate multiplex rRT-PCR qualitative diagnostic method, which targets two viral genes E (envelope protein), N (nucleocapsid gene, according to the CDC, USA guidelines for the development of RT-PCR kit and one human gene RNase P as internal control simultaneously. This is a case control study where will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). This specimen will be blinded before supplying over to NILMRC/Contact ROL/ Bangladesh Clinical Trail Limited (BCTL), Dhaka, Bangladesh for Bangladesh Reference Institute for Chemical Measurements (BRiCM) RT-PCR Kit. Required in house validation will also be conducted as per International Council for Harmonization (ICH) and FDA guideline and also external validation will be carried in different Director General of Health Service (DGHS), Bangladesh approved COVID-19 diagnostic laboratory. Data will be analyzed by computer using Statistical Package for the Social Sciences (SPSS) software and will be presented into the frequency table, graph and chart according to the requirements.
Adolescent girls are the highly vulnerable group to develop anemia due to reproductive immaturities, poor personal hygiene, lack of nutritional intake, and lack of health education in the rural area of Bangladesh. Rapid advantage of technology, eHealth is the promising tool to overcome the barriers and provide appropriate health guidelines in distant rural communities by developing knowledge, attitude, and practice to reduce anemia and mitigate risk among the school-going adolescent girls. This research aims (1) To evaluate eHealth education's impact on reducing anemia among adolescent girls in rural Bangladesh. (2) To assess the effect of eHealth education to change the knowledge, attitude, and practice among adolescent girls regarding anemia. A Randomized Control Trial study will be conducted from May 22, 2022, to January 21, 2023, in the two schools at the Chandpur district, Bangladesh. During the 8th months' intervention, will be provided eHealth education by the trained community health worker. The participant will be allocated who will be diagnosed as anemic through the blood hemoglobin screening. The sample size was calculated, and the total sample is 138. In this study, one school will be considered an intervention group and another school control group through the simple coin toss randomization technique. Then random sampling technique will be used to select study participants.
The purpose of this study is to assess the impact of using autonomous artificial intelligence (AI) system for identification of diabetic retinopathy (DR) and diabetic macular edema on productivity of retina specialists in Bangladesh. Globally, the number of people with diabetes mellitus is increasing. Diabetic retinopathy is a chronic, progressive complication of diabetes mellitus that affects the microvasculature of the retina, which if left untreated can potentially result in vision loss. Early detection and treatment of diabetic retinopathy can prevent potential blindness. Study Aim: To assess the impact of using autonomous artificial intelligence (AI) system for detection of diabetic retinopathy (DR) and diabetic macular edema on physician productivity in Bangladesh. Main study question: Will ophthalmologists with clinic days randomized to use autonomous AI DR detection for all persons with diabetes (diagnosed or un-diagnosed) visiting their clinic system have a greater number of examined patients with diabetes (by either AI or clinical exam), and a greater complexity of examined patients on a recognized grading scale, per physician working hour than those randomized not to have autonomous AI screening for their diabetes population? The investigators anticipate that this study will demonstrate an increase in physician productivity, supporting efficiency for both physicians and patients, while also addressing increased access for DR screening; ultimately, preventing vision loss amongst diabetic patients. The study has the potential to contribute to the evidence base on the benefits of AI for physicians and patients. Additionally, the study has the potential to demonstrate the benefits (and/or challenges) of implementing AI in resource-constrained settings, such as Bangladesh.
Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited settings. The goal of the Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS) phase II L. plantarum trial is to generate knowledge on the safety, tolerability and effects on the microbiome of Lactiplantibacillus plantarum, with or without fructooligosaccharide, in infants (birth to 60 days of age) in Dhaka, Bangladesh. All data generated will support the design and implementation of a phase III trial to test the efficacy of the probiotic/synbiotic or other interventions for the prevention of SI, promotion of optimal growth and development, and effects on other health outcomes in early infancy.
Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease. It is also used for the treatment of psoriatic arthritis, ankylosing spondylitis, and Crohn's disease etc. Adalimumab binds specifically to TNF-α and blocks its general cytokine effects, thereby reducing TNF-induced inflammation and halting tissue destruction. Adalimumab was approved for medical use in the United States in 2002. It is on the World Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2017, it was the 169th most commonly prescribed medication in the United States, with more than three million prescriptions. Adalimumab is an expensive product which is indicated in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, etc. Each patient will be provided the study drug free of cost in this study which will benefit them immensely. The advent of therapeutic monoclonal antibodies has given a major boost to the treatment of individuals suffering from autoimmune disorders, including rheumatoid arthritis. Adalimumab is one such therapeutic monoclonal antibody used for treatment of rheumatoid arthritis marketed with brand name Humira by Abbvie Ltd. (USA) was the only adalimumab biosimilar available for patients in Bangladesh until recently. Incepta Pharmaceuticals Ltd. Bangladesh has introduced Bangladesh's first locally manufactured adalimumab biosimilar Advixa that is available at a fraction of Humira's cost. This study aims to evaluate the pharmacokinetics, safety and efficacy of the Adalimumab biosimilar (Advixa) in comparison to Adalimumab (Humira) as reference. The biosimilar Advixa being a local product will a cost-effective alternative to imported drugs currently available in the market. Objectives of the Protocol General objectives- 1. To assess the Pharmacokinetic between Test Product (A): Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd of Bangladesh and the corresponding Reference Product (B): Humira 40 mg/ 0.4ml of Abbvie Ltd in normal, healthy, adult, human subjects in a Parallel group study. 2. To evaluate the safety between two products. 3. To assess efficacy, tolerability and safety of biosimilar adalimumab (Advixa, Incepta) in compared with reference adalimumab (Humira, AbbVie) in patients with moderate to severe rheumatoid arthritis (RA). Specific objectives- 1. Pharmacokinetic (PK) Parameters: For Cmax and AUC0-t the 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%. 2. Safety assessment: Evaluation and comparison between references vs. test drug in terms of safety end point. 3. Efficacy assessment: The primary endpoints will be - 1. Proportion of patients with an ACR20 response in both the treatment groups at week 12. 2. Evaluation and comparison of safety between references vs. test drug. The secondary endpoints will be - 1. Change in Disease Activity Score of 28 joints - CRP (DAS28-CRP), 2. Proportion of patient with an ACR50 response and 3. Proportion of patients with an ACR70 response in both the treatment groups at week 12.