Displaying all 9 publications

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  1. Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, et al.
    Nepal J Epidemiol, 2020 Sep;10(3):878-887.
    PMID: 33042591 DOI: 10.3126/nje.v10i3.31622
    Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants' inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19" AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.
  2. Sathian B, Asim M, Banerjee I, Roy B, Pizarro AB, Mancha MA, et al.
    Nepal J Epidemiol, 2021 Mar;11(1):959-982.
    PMID: 33868742 DOI: 10.3126/nje.v11i1.36163
    Background: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines.

    Methods: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020.

    Results: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time.

    Conclusion: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.

  3. Banerjee I, Sathian B, Gupta RK, Amarendra A, Roy B, Bakthavatchalam P, et al.
    Nepal J Epidemiol, 2016 Jun;6(2):574-581.
    PMID: 27774346
    In developing countries like Nepal medicines can be acquired from the chemist's without of a prescription which sometime may have many drawbacks due to intake of excessive drugs without a proper diagnosis. The primary objective of the study was to find out the pattern of self-medication practice among the preclinical medical students at Manipal College of Medical Sciences.
  4. Aryal N, Regmi PR, Faller EM, van Teijlingen E, Khoon CC, Pereira A, et al.
    Nepal J Epidemiol, 2019 Sep;9(3):788-791.
    PMID: 31687253 DOI: 10.3126/nje.v9i3.25805
    This paper reports on a consultation meeting that discussed two emerging health issues of Nepali migrant workers in Malaysia and the ways they can be addressed. Primarily, it focused on the issue of sudden cardiac deaths of Nepali migrant workers in Malaysia. This issue has been raised internationally by both scientific and media in the recent years. Secondly, it discussed kidney health related problem among Nepali migrant workers which has caught the attention of Nepali media recently. The meeting was organized in Kuala Lumpur, Malaysia on 19th April, 2019 where twenty people including health researchers, representatives of migrant related national and international organizations, and Nepali migrant workers participated. The meeting concluded that three types of data collection are needed: (1) good record of deaths, if at possible proper post-mortems; (2) a verbal autopsy tool to help identify underlying causes ; and qualitative research into kidney related problems.
  5. Sathian B, Menezes RG, Asim M, Mekkodathil A, Sreedharan J, Banerjee I, et al.
    Nepal J Epidemiol, 2020 Mar;10(1):821-829.
    PMID: 32257512 DOI: 10.3126/nje.v10i1.28277
    Background: Worldwide, tobacco smoking is a major risk factor for morbidity and early mortality among adult population. The present study aimed to find out the association between current smoking and suicidal ideation among young people in Nepal.

    Materials and Methods: A cross-sectional questionnaire-based survey was carried out among 452 youths from Pokhara, Nepal. The present study included both genders (age 18-24 years) who were smokers as well as non-smokers.

    Results: Across the study period, 452 participants were identified after matching for age, and sex (226 in the smoking group and 226 in the non-smoking group). The mean age of participants was 21.6±1.2 years and 58.8% were males. The overall rate of suicidal ideation in our cohort was 8.9%. Smokers were slightly more likely to report suicidal ideation than non-smokers (aOR 1.12). The risk of developing suicidal ideation was 3.56 (95% CI 1.26-10.09) times more in individuals who smoked greater than 3.5 cigarettes per week (p=0.01).

    Conclusion: The rate of suicidal ideation was slightly higher among smokers and a dose-response relationship was identified with the number of cigarettes smoked per week. Being aware of the link between smoking and suicidal ideation may help health care professionals working with young people to address more effectively the issues of mental well-being and thoughts about suicide.

  6. Roy B, Murugesan K, Mathanmohun M, Sathian B
    Nepal J Epidemiol, 2023 Dec;13(4):1294-1297.
    PMID: 38299042 DOI: 10.3126/nje.v13i4.61245
    Nanoparticles (NPs) are small particles with a surface area ranging from 1 to 100 nm in diameter that are rampantly used in different fields, e.g., medicine, engineering, and others. Because of their unique properties, such as their tiny size, magnetic properties, quantum size effects, and macroscopic quantum tunnelling effects, they are crucial for a wide range of potential applications. NPs play a significant role in the treatment of vascular disorders, the production of vaccines, and the development of drug carriers for diverse therapies due to their bioavailability, targeting ability, and efficacy. However, significant risks to the environment and health are also associated with it. NPs cause necrotic plasma membrane rupture or apoptosis, which leads to cell death. NPs interfere with cell signalling, endosomal membranes, and organelles like the nucleus or mitochondria, affecting their function. NPs cause autophagic cell death, which causes a stress response and sterile inflammation. The primary routes for the entry of NPs into the human body are inhalation, ingestion, and skin contact. NPs accumulate in the respiratory system based on their size, shape, and surface properties. NPs can cause lung inflammation and fibrosis, disrupt the endocrine system by attaching to hormone receptors, and produce reactive oxygen species (ROS) associated with DNA damage, oligospermia, and male infertility. Carcinogenic properties of NPs cause mutations, apoptosis, and inflammatory responses. Collaborative research between ecologists and epidemiologists may enlighten ways to reduce the harmful effects of NPs.
  7. Sathian B, van Teijlingen E, Roy B, Kabir R, Banerjee I, Simkhada P, et al.
    Nepal J Epidemiol, 2023 Dec;13(4):1292-1293.
    PMID: 38299043 DOI: 10.3126/nje.v13i4.61271
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