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.
15 June 2014 in Asian Pacific Journal of Cancer Prevention
Awareness of Breast Cancer Warning Signs and Screening Methods among Female Residents of Pokhara Valley, Nepal Questionnaire;breast cancer;breast self-examination;mammogram;warning sign;Nepal; Background: Breast cancer is the second most common cancer in the world and by far the most frequent cancer among women. Objective: The present study was undertaken to assess the awareness of breast cancer warning signs and screening methods among the women of Pokhara valley, Nepal. Materials and Methods: A cross-sectional questionnaire survey was carried out in a community setting with the female population. The questionnaire was administered in face-to-face interviews by trained research assistants. Results: Nepalese women demonstrated poor awareness of warning signs like a breast lump, lump under the armpit, bleeding or discharge from the nipple, pulling of the nipple, changes in the position of the nipple, nipple rash, redness of the breast skin, changes in the size of the breast or nipple, changes in the shape of the breast or nipple, pain in the breast or armpit, and dimpling of the breast skin. While 100% of nurses were aware about breast self-examination(BSE), mammography and warning signs of breast cancer. Levels of knowledge were significantly poorer in women with other occupations. Graduates were more aware about BSE, mammogram and warning signs of breast cancer compared to those with other educational levels. Conclusions: The findings indicated that the level of awareness of breast cancer, including knowledge of warning signs and BSE, is sub-optimal among Nepalese women.
Background: SARS-CoV-2 is an RNA virus that undergoes mutation producing a variety of strains. Mutagens include UV radiation, metals, and endogenous components of organisms. Each strain is specific in terms of virulence, immune response in the body and efficacy of the vaccines. Conclusion: Researchers need to gather data and collaborate with global organizations to learn about the newly evolving strains. Information about the mutations and variants are inevitable in understanding virus transmission and developing vaccines to end the COVID-19 pandemic.
Introduction: 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.Materials and Methods: This was a cross sectional study carried out using structured questionnaire at Manipal College of Medical Sciences, Pokhara, Nepal between November 2012- July 2014.Results: The overall response rate of this study was 95.31%. 81.35% of the students were practicing self-medication in this institution. Most common group of drugs that were consumed were antipyretics 31%, antibiotics 26.2%, analgesics 18.89%, antihistaminics 10.1% respectively. Paracetamol was the most common drug used for self-medication 31%, followed by Azithromycin 17.6% and combination of Paracetamol and Ibuprofen 15.6%, Cetirizine 8.6%, Amoxicillin 6.5%, Omeprazole 6.3%, Albendazole 3.3%, Mefenemic acid 2.8%, Cefpodoxime2% respectively. Conclusion: Medical student should be educated through awareness programme regarding pros and cons of self-medication practice and they should be motivated regarding the rationale use of antibiotics.
Introduction: 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. Conclusions: Our findings invited a revisit to the reported solicited and unsolicited SAE 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.