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Objectives: The COVID-19 pandemic has led to significant morbidity and mortality in lung transplant recipients (LTR). Respiratory viral infections may be associated with de-novo HLA donor-specific antibody (DSA) production and impact lung transplant outcome. Since one of the immunomodulation strategies post-SARS-CoV-2 infection in LTR include decreasing or holding anti-metabolites, concerns have been raised for higher incidence of de-novo DSA production in LTR. Method(s): We performed a retrospective chart review of 80 consecutive LTR diagnosed with COVID-19 to investigate this concern. COVID-19 disease severity was divided into 3 groups: mild, moderate, and severe. Mild disease was defined as patients with COVID-19 diagnosis who were stable enough to be treated as out-patients. Moderate disease was defined as patients who required admission to the hospital and were on less than 10 liters of oxygen at rest. Severe disease was identified as patients who required hospitalization and were on more than 10 liters of oxygen with or without mechanical ventilation or extra corporal membrane oxygenation (ECMO). Groups were compared using the Kruskal-Wallis test. Result(s): A total of 23, 47, and 10 LTR were diagnosed with mild, moderate, and severe COVID-19 respectively. De-novo HLA DSAwere detected in 0/23 (0%), 3/47 (6.3%), and 4/10 (40%) LTR with mild, moderate, and severe COVID-19 respectively (p = 0.0007) within 6 months post-COVID-19 diagnosis. Conclusion(s): Severe COVID-19 may be associated with increased risk of de novo HLA DSA production resulting in allograft dysfunction.Copyright © 2023 Elsevier Inc.
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Background: During the coronavirus disease 2019 (COVID-19) pandemic, established best practices in cancer care were modified to diminish the risk of COVID-19 infection among patients and health-care workers. Objective(s): We aimed to study the modifications in cancer-directed therapy during the first wave of the COVID-19 pandemic. Material(s) and Method(s): A cross-sectional study of patients with cancers of the head and neck, thoracic, urologic, and central nervous systems who visited the medical oncology department of the Tata Memorial Hospital, Mumbai, India, between April 22, 2020 and June 01, 2020, was conducted. Data were prospectively collected in an online pro forma and supplemented from the electronic medical records. Result(s): Of a total of 514 patients, 363 (71%) were men. The most common malignancy was lung cancer in 234 patients (46%). Cancer-directed therapy was modified in 83 patients (16%). Deviations consisted of modification of the chemotherapy regimen (48%), temporary discontinuation of chemotherapy in 37%, and interim chemotherapy to delay surgery in 5%. Changes in the chemotherapy regimen included a shift to a less intensive regimen in 45%, changing from intravenous to oral in 40%, and less frequent dosing of immunotherapy in 7%. Considering missed appointments as a deviation from planned cancer therapy, 68% of patients had a deviation in the standard planned cancer care. Conclusion(s): Almost two-thirds of the patients could not reach the hospital during the COVID-19 pandemic lockdown in India. Of those who could reach the hospital, one of out every six patients with cancer had a change in their cancer-directed treatment, half of which consisted of a modification in the standard chemotherapy regimens. The effects of these therapy deviations are likely to be long-lasting. (Clinical Trials Registry-India, CTRI/2020/07/026533).Copyright © 2023 Neurology India, Neurological Society of India Published by Wolters Kluwer - Medknow.
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Objective: To compare etiological frequencies in patients of acute pancreatitis presenting to our setup with international data. Study Design: Cross-sectional study Place and Duration of Study: Department of Gastroenterology, Pakistan Emirates Military Hospital & Combined Military Hospital, Rawalpindi Pakistan, from Aug 2020 to Jan 2022. Methodology: Patients over 12 years suffering from pancreatitis were recruited using a convenience sampling technique based upon predefined criteria for diagnosis of pancreatitis on a questionnaire. Relevant basic lab tests, including chemistries and imaging, including Ultrasound abdomen and CECT abdomen, were analyzed to establish aetiology. Data were continuously uploaded into an electronic data sheet. International Consensus Diagnostic Criteria (ICDC) algorithms were applied to diagnose autoimmune pancreatitis. Results: Out of 120 patients, 74(61.7%) were males, and 46(38.3%) were females. Biliary pancreatitis was the most common aetiology 50(41.7%), followed in descending order by idiopathic 36(30%), drug-induced pancreatitis (DIP) 9(7.5%), Post ERCP Pancreatitis (PEP) 8(6.7%), tumours 5(4%), Autoimmune pancreatitis (AIP), Hypertriglyceridemia and alcohol-induced pancreatitis each 2(1.7%). Conclusion: Biliary pancreatitis has the highest frequency, followed by idiopathic and drug-induced pancreatitis. © 2023, Army Medical College. All rights reserved.
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Objectives: More than 200 patients have benefited from lung transplantation who failed to recover from COVID-19-induced acute respiratory distress (ARDS) with conventional ventilatory support and/ or extracorporeal membrane oxygenation support (ECMO) in USA. We aim to share our experience and lessons learned at our institute through this case series. Method(s): After IRB approval, we performed a retrospective chart review and identified 37 patients who received ECMO for COVID-19 induced ARDS between May 2020 through January 2022. Out of these, 12 received a formal consultation from the transplant team. We studied patient characteristics, interventions during ECMO support, and evaluation outcomes. Result(s): Most of our patients had single organ failure i.e., lung, except for two who required dialysis after ECMO initiation. Six out of the 12 patients received bilateral lung transplant. One patient received the transplant before ECMO initiation. However, the patient required two runs of ECMO after the transplant due to postop complications from suspected COVID19 reinfection and deceased on postoperative day 101. All the patients after transplant had an expedited recovery except one who required prolonged hospitalization before starting physical therapy. The median length of hospital stay for the transplant group was 148 (89- 194) days and for the non-transplant group was 114 (58-178) days. The 30-day survival rate was 100% for the transplant group. At a median follow-up of 207 (0- 456) days after discharge, 5(83.3%) patients in the transplant group and 3(50%) patients in the nontransplant group were alive. In the non-transplant group, 4 patients received ECMO support for more than 75 days and at last follow-up 2 were alive and functioning well without needing new lungs. This asks for an objective prospective study to define the timeline of irreversibility of the lung injury. Conclusion(s): Lung transplantation is a viable salvage option in patients with COVI-19 induced irreversible lung injury. However, the irreversibility of the lung injury and the timing of lung transplant remains to be determined case-by-case. (Figure Presented).
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Objective: Malaysia's first case of coronavirus disease (COVID-19) was reported in January 2020, with the first case in the state of Negeri Sembilan diagnosed on 17 February 2020. The National COVID-19 Immunisation Programme commenced in early March 2021 in Negeri Sembilan. This study describes the COVID-19 cases and vaccination coverage in Seremban District, Negeri Sembilan, during 2021. Methods: The demographic and clinical characteristics of COVID-19 cases and the district's vaccination coverage were described. Vaccination coverage was plotted against COVID-19 cases on the epidemic curve. The chi-square test was used to examine the differences between the vaccination status of COVID-19 cases and severity category, hospitalization status and mortality. Results: In Seremban District, there were 65 879 confirmed cases of COVID-19 in 2021. The data revealed that the 21–30-year age group had the highest proportion of cases (16 365;24.8%), the majority of cases were male (58.3%), and most cases were from the sub-district of Ampangan (23.1%). The majority of cases were Malaysian. Over half (53.5%) were symptomatic, with fever (29.8%) and cough (22.8%) being the most frequently reported symptoms. COVID-19 vaccination status was significantly associated with severity category, hospitalization and mortality (P < 0.001 for all categories). Discussion: This is the first study to describe two-dose vaccination coverage and the trend in COVID-19 cases in Seremban District. It was observed that COVID-19 cases had been reduced following more than 60.0% vaccination coverage. © 2023, World Health Organization. All rights reserved.
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Introduction: As the U.S. population ages, gastroenterologists will provide care for an increasing number of older patients - many of whom use Medicare. In recent years there have been significant policy changes surrounding Medicare reimbursement for physicians. Understanding reimbursement trends can help reveal the financial impact of these policies on gastroenterologists. Our study aims to analyze the trends in Medicare reimbursement of common gastrointestinal (GI) services from 2007 to 2022. Method(s): The top 10 GI procedures and their respective CPT codes were identified through a joint list published by the American College of Gastroenterology, American Society of Gastrointestinal Endoscopy, and American Gastroenterological Association. The top 5 5 CPT codes relating to office/inpatient visits provided by gastroenterologists to Medicare Part B beneficiaries was identified using data from CMS. The Physician Fee Schedule Look-Up Tool from CMS was queried for the selected CPT codes from 2007 to 2022, to determine the facility reimbursement rate by Medicare for each service. The reimbursement data were adjusted to January 2022 U.S. dollars using the U.S. Department of Labor's Bureau of Labor Statistics' consumer price index inflation calculator. Result(s): The unadjusted physician reimbursement for GI procedures exhibited an average decrease of 7.0% (95% CI, 29.9% to 24.1%) from 2007 to 2022. After adjusting for inflation, the mean decrease in physician reimbursement for procedures was 33.0% (95% CI, 235.1% to 230.9%). The mean annual growth rate in reimbursement was 22.6% (95% CI, 22.8% to 22.4%). The unadjusted physician reimbursement for inpatient and outpatient visits exhibited an average increase of 32.1% (95% CI, 4.8% to 59.3%). After adjusting for inflation, physician reimbursement for patient visits exhibited a mean decrease of 4.92% (Figure 1). Conclusion(s): The analysis revealed a steady decline in adjusted and non-adjusted reimbursement between 2007 and 2022. Decreasing Medicare reimbursement may impact health outcomes, healthcare access, and patient satisfaction. Reimbursement policies must be scrutinized particularly in the light of high inflation and increased costs due to additional costs associated with care during the COVID-19 pandemic, staffing shortages, and increased staffing salaries. (Figure Presented).
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The novel coronavirus (COVID-19)poses unprecedented challenges to global economy and international development and has become a humanitarian crisis affecting millions of lives and livelihoods throughout the world. It affects almost every economic activity and operation and at the same time poses a threat to every sector of the economy, people, places, and businesses. COVID-19 brought not only crisis, disruptions, and challenges but also bred fertile ground for opportunities, innovations, and digitalization of economic sectors. In this context, this chapter focuses keenly on the economic impacts of the COVID-19 crisis, including the economic challenges and opportunities it creates, and accordingly, recommendations have been presented. © 2023, IGI Global. All rights reserved.
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The N protein of the SARS-CoV-2 virion is critical for viral genome packaging via RNA binding and regulation of viral transcription at the replication-transcription complex (RTC). The N protein can be divided into five main domains, and the central region is the linker, which is predicted to be primarily disordered and has not been heavily studied. The linker is Serine-Arginine Rich, which is phosphorylated at multiple sites by host kinases during infection, thereby promoting the N protein's role in viral transcription. Phosphorylation is a critical process for the regulation of many cellular processes and can provide recognition sites for binding complexes. In a study that examined the recognition of the SARS-CoV-2 N protein by the human 14-3-3 protein, the linker was found to contain critical phosphosites for 14-3-3 binding. The goals of this project are to determine the structure, dynamics, and RNA interactions of the Serine-Arginine Rich linker region. To accomplish this, we performed Nuclear Magnetic Resonance spectroscopy (NMR) experiments to analyze the structure of the linker region of the N protein and its ability to bind viral RNA. NMR confirms predictions that the linker is not entirely unstructured and it is able to bind RNA. The linker region of the N protein with phosphoserine incorporated at S188 was also examined via an NMR titration experiment with 1-1000 RNA. Compared to wild type, the incorporation of phosphorylation decreases binding. Other biophysical techniques such as Analytical Ultracentrifugation (AUC) and Multi-Angle Light Scattering (MALS) are used to identify the association state of the linker and the size of the resulting protein-RNA complex. We are currently working to biophysically characterize the structure, dynamics, and viral RNA binding ability of a mutation found in the Delta and Omicron variants: the R203M linker, which have been shown to enhance viral infectivity. This work was supported by the NSF EAGER grant NSF/ MCB 2034446 and URSA Engage. Support to facilities includes the Oregon State University NMR Facility funded in part by NIH, HEI Grant 1S10OD018518, and by the M. J. Murdock Charitable Trust grant # 2014162.Copyright © 2023 The American Society for Biochemistry and Molecular Biology, Inc.
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The objective of this research was to understand key levers that enabled city, regional, and national governments to improve non-motorized transport (NMT) infrastructure during the lockdowns necessitated by the COVID-19 pandemic. The research focused primarily on cycling and adopted a case study approach focusing on three cities: Bengaluru (India), Bogota (Colombia), and London (UK). The selected cities were chosen for diversity across geographies, country income levels, and the scale of interventions. Eight key levers were identified to understand how cycling interventions can be supported, implemented, sustained, and scaled up. These included institutional and organizational arrangements;technical capacity;financing;leadership;policy and regulatory framework;plans, strategies, and technical resources;role of civil society;and communications, messaging, and outreach. The research used secondary literature reviews and key informant interviews, which were validated through an online round table. Research revealed that certain levers were necessary in initiating and continuing successful NMT interventions. These included supportive leadership, participative civil society, and adequate financial and technical capacity. Communications and outreach helped bring behavioral change amongst residents while a coordinated institutional framework and plans and strategies were necessary to sustain momentum. This research contributes to urban mobility and public administration literature in understanding processes and enablers of sustainable mobility interventions. It is relevant for cities in low-and middle-income countries beginning to focus on NMT interventions to combat climate change and public health challenges. © National Academy of Sciences: Transportation Research Board 2021.
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In present study, the inhibitory potential of Neolamarckia cadamba phytoconstituents was investigated against SARS-CoV-2 3CL protease (3CL pro) (PDB ID: 6M2N). Molecular docking was analyzed using AutoDock Vina software by setting the grid parameter as X=-33.163, Y=-65.074 and Z= 41.434 with dimensions of the grid box 25 × 25 × 25 Å. Remdesivir was taken as the standard for comparative analysis along with inhibitor 5, 6, 7-trihydroxy-2-phenyl-4H-chromen-4-one. Furthermore, the exploration of 2 D Hydrogen-bond interactions was performed by Biovia Discovery Studio 4.5 program to identify the interactions between an amino acid of target and ligand followed by assessment of physicochemical properties using Lipinski's rule and Swiss ADME database. The decent bonding scores of secondary metabolites owing to hydrogen bonding with catalytic residues suggest the effectiveness of these phytochemicals towards 3CLpro. The results are further consolidated positively by Lipinski's rule and Swiss ADME prediction. Thus reasonably, observations with docking studies suggest possibility of phytochemicals from Neolamarckia cadamba to inhibit the 3CLpro and consequently would be explored further as agents for preventing COVID-19. © 2023, Universidade Federal de Mato Grosso do Sul, Departamento de Quimica. All rights reserved.
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Background Understanding health trends and estimating the burden of disease at the national and subnational levels helps policy makers track progress and identify disparities in overall health performance. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides comprehensive estimates for Pakistan. Comparison of health indicators since 1990 provides valuable insights about Pakistan's ability to strengthen its health-care system, reduce inequalities, improve female and child health outcomes, achieve universal health coverage, and meet the UN Sustainable Development Goals. We present estimates of the burden of disease, injuries, and risk factors for Pakistan provinces and territories from 1990 to 2019 based on GBD 2019 to improve health and health outcomes in the country. Methods We used methods and data inputs from GBD 2019 to estimate socio-demographic index, total fertility rate, cause-specific deaths, years of life lost, years lived with disability, disability-adjusted life-years, healthy life expectancy, and risk factors for 286 causes of death and 369 causes of non-fatal health loss in Pakistan and its four provinces and three territories from 1990 to 2019. To generate estimates for Pakistan at the national and subnational levels, we used 68 location-years of data to estimate Pakistan-specific demographic indicators, 316 location-years of data for Pakistan-specific causes of death, 579 location-years of data for Pakistan-specific non-fatal outcomes, 296 location-years of data for Pakistan-specific risk factors, and 3089 location-years of data for Pakistan-specific covariates. Findings Life expectancy for both sexes in Pakistan increased nationally from 61 center dot 1 (95% uncertainty interval [UI] 60 center dot 0-62 center dot 1) years in 1990 to 65 center dot 9 (63 center dot 8-67 center dot 8) years in 2019;however, these gains were not uniform across the provinces and federal territories. Pakistan saw a narrowing of the difference in healthy life expectancy between the sexes from 1990 to 2019, as health gains for women occurred at faster rates than for men. For women, life expectancy increased by 8 center dot 2% (95% UI 6middot3-13middot8) between 1990 and 2019, whereas the male life expectancy increased by 7 center dot 6% (3 center dot 5-11 center dot 8). Neonatal disorders, followed by ischaemic heart disease, stroke, diarrhoeal diseases, and lower respiratory infections were the leading causes of all-age premature mortality in 2019. Child and maternal malnutrition, air pollution, high systolic blood pressure, dietary risks, and tobacco consumption were the leading all-age risk factors for death and disability-adjusted life-years at the national level in 2019. Five non-communicable diseases-ischaemic heart disease, stroke, congenital defects, cirrhosis, and chronic kidney disease-were among the ten leading causes of years of life lost in Pakistan. Burden varied by socio-demographic index. Notably, Balochistan and Khyber Pakhtunkhwa had the lowest observed gains in life expectancy. Dietary iron deficiency was the leading cause of years lived with disability for both men and women in 1990 and 2019. Low birthweight and short gestation and particulate matter pollution were the leading contributors to overall disease burden in both 1990 and 2019 despite moderate improvements, with a 23 center dot 5% (95% UI 3 center dot 8-39 center dot 2) and 27 center dot 6% (14 center dot 3-38 center dot 6) reduction in age-standardised attributable DALY rates during the study period. Interpretation Our study shows that progress has been made on reducing Pakistan's disease burden since 1990, but geographical, age, and sex disparities persist. Equitable investment in the health system, as well as the prioritisation of high-impact policy interventions and programmes, are needed to save lives and improve health outcomes. Pakistan is facing several domestic and foreign challenges-the Taliban's return to power in Afghanistan, political turmoil, catastrophic flooding, the COVID-19 pandemic-that will shape the trajectory of the country's health and development. Pakistan must address the burden of infectious disease and curb rising rates of non-communicable diseases. Prioritising these three areas will enhance Pakistan's ability to achieve universal health coverage, meet its Sustainable Development Goals, and improve the overall health outcomes.
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E-government and the implementation of ICT technologies in the public sector has been in the center of interest for a few decades now, but it is a fact that the Covid-19 pandemic and the worldwide lockdowns have given a boost on their prosecution in our everyday lives. The aims of this study were to i) examine the implementation of digital transformation best practices utilized by the governments globally and ii) take a thorough look in the case of Greece, to determine whether and to what extent the Greek government adopted similar practices and initiatives, allowing the use of online digital services to citizens in a wide array of public sector areas during the Covid-19 pandemic. Initially, we sent a questionnaire to 202 people in Greece, via email and social media platforms. In response, 150 useable questionnaires were received with response rate of 74%. We gathered responses were gathered between May and June 2021, and data gathered were analyzed with PSPP statistical program. The results showed that the majority of the practices used by the government were well communicated, as most of the digital services were acknowledged by the participants even if they had not used them. In particular, the taxation portal and the central digital portal for governmental services were used in percentages of 76% and 66% respectively. In terms of use and satisfaction, responses were also quite encouraging, with 72% of the participants mentioning being very satisfied with the speed and quality of the new digital services, though leaving room for further research to conclude on improvement methods. After in-depth examination of the global and Greek progress of digital transformation during the COVID-19 pandemic, it is essential to state that all governments have shown tremendous improvement in order to cover citizens' needs, while using the majority of the available digital channels.
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A 66-year-old male with end-stage liver disease (ESLD) secondary to non-alcoholic fatty liver disease (NAFLD), complicated by hepatocellular carcinoma (HCC), underwent deceased donor liver transplantation from a Coronavirus disease 2019 (COVID-19) positive donor. He presented a month later with fever, diarrhea and pancytopenia which led to hospitalization. The hospital course was notable for respiratory failure, attributed to invasive aspergillosis, as well as a diffuse rash. A bone marrow biopsy revealed hypocellular marrow without specific findings. In the following days, laboratory parameters raised concern for secondary hemophagocytic lymphohistiocytosis (HLH). Clinical concern also grew for solid organ transplant graft-versus-host-disease (SOT-GVHD) based on repeat marrow biopsy with elevated donor-derived CD3+ T cells on chimerism. After, a multidisciplinary discussion, the patient was started on ruxolitinib, in addition to high dose steroids, to address both SOT-GVHD and secondary HLH. Patient developed symptoms concerning for hemorrhagic stroke and was transitioned to comfort care. Although GVHD has been studied extensively in hematopoietic stem cell transplant (HSCT) patients, it is a rare entity in SOT with a lack of guidelines for management. Additionally, whether COVID-19 may play a role in development of SOT-GVDH has not been explored.Copyright © 2023 The Authors
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Background & objectives: The most common clinical presentation of COVID 19 is acute respiratory distress syndrome. Due to its rapid and risky course of transmission and limited medical facilities, it is important to identify the patients with hampered lung function with minimal chance of aerosol spread. As conventional spirometry increases the chances of infection transmission, a breath-holding test can be used to determine vital capacity and cardiopulmonary reserve. Method(s): From May 11 to June 4, 2020, a randomly sampled study was conducted in a tertiary care hospital, Ahmedabad. Patients aged between 18-65 years with mild to moderate COVID 19 infection and who were vitally stable were included in the study. In all participants, the breath-holding test was performed and vital capacity and cardiopulmonary reserve were measured. Result(s): 16 females and 34 males, with a mean age of 45.82+/-12.08, were included in the study. Average Breath-holding time was 28.56 - 15.20 seconds, vital capacity was 3400+/-892.142 liters. Patients had 32%, 56% and 12% grade 0, 1 and 2 cardiopulmonary reserves respectively. Interpretation & conclusion: From our study, we concluded that vital capacity and cardiopulmonary reserve are compromised in patients with mild to moderate covid 19 infections. No Patients with more than two comorbidities had normal cardiopulmonary reserve and even vital capacity was lowest in them, when compared to patients with no comorbidities.Copyright © 2020 Ubiquity Press. All rights reserved.
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Halal tourism witnessed significant growth during the second half of the decade ended on December 2020 with the COVID-19 pandemic. This expansion can be witnessed equally in academic research and the Halal tourism industry. Keeping in view the phenomenal growth this research reviews the very high-quality research literature on Halal tourism to consolidate its findings and recommendations. It performs a thematic analysis of 74 articles published between the period 2009 to 2020 i.e., up to before the beginning of the COVID-19 pandemic, listed in the A* and A ranked journals of the Australian Business Deans Council (ABDC). It consolidates research methodologies, themes, dependent/independent and mediating/moderating variables, which ultimately lead to a master conceptual framework of research. It highlights that the research on Halal tourism is in its developing stages, with more themes emerging in recent years. It suggests that every country must reflect the blend of its own culture duly enveloped in the Shariah parameters. Finally, this review of the literature highlights a nexus between Social values, tourism services, and Islamic stipulations, as a way forward for research and developments in the Halal tourism research and industry.
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The COVID-19 pandemic left a lot of people sick, tired, and frustrated. Many people expressed their feelings on social media through comments and posts. Detecting hate speech on social media is important to help reduce the spread of racist comments. Machine learning algorithms can be used to classify hate speech. In our experiments, we implement semi-supervised machine learning algorithms to classify Twitter data. We used a count vectorizer as the feature and a support vector machine (SVM) classifier to classify COVID-19 related Twitter data while changing the amount of labeled data available. We found that self-training semi-supervised machine learning has similar effectiveness to supervised learning when there is significantly less training data available. © 2022 IEEE.
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An emergency shift to online education after Covid-19 brought many challenges for students and teachers, especially the university students living in the rural areas of Pakistan. So this study has focused on assessing the problems students faced while acquiring online education with special reference to the theoretical background of digital divide. It is a quantitative study which employed Heckman's treatment effect model to analyze the impact of digital divide on university students' performance. The results of the study indicate that online education further increases an already existing digital divide between have and have nots. Online education is a good alternate of face-to-face education in many cases however for ensuring maximum benefits of online education requires proper availability of gadgets and internet access along with training. Existing online education system in developing countries like Pakistan may be more suitable to teach theoretical subjects like social sciences which are subjective in nature however it is not much appropriate for teaching numerical subjects. The findings of the study direct a positive impact of digital divide due to the scarcity of necessary gadgets, internet access, family income, gender, field of study, age and location © 2023, Turkish Online Journal of Distance Education.All Rights Reserved.
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The COVID-19 pandemic has exposed numerous unresolved research ethics challenges particularly for Data Monitoring Committees (DMCs). DMCs have worked to ensure the ongoing social value of research as rapid changes occur in health policy and epidemiology and there is substantial pressure to release early findings to the public. Unlike Institutional Review Boards, DMCs are charged with carefully monitoring ongoing research, but with limited ethical guidance and often without representation from all host countries. This article highlights ethical challenges for DMCs and lessons learned from the COVID-19 pandemic. DMCs have long faced high-stakes decisions in clinical trials including whether to continue, modify, or terminate a trial based on emerging trial data. Trial protocols, statistical analysis plans, and data monitoring charters establish principles for DMC decisionmaking;however, there has not been a great deal of systematic examination of the ethical issues faced by DMCs. For example, which ethical considerations should be addressed by DMCs as opposed to Institutional Review Boards or researchers is often unclear. Formal guidance rarely addresses whether DMCs should monitor the representativeness of trial participants as compared with the target population for the intervention. Furthermore, post-trial issues have received limited attention. Should DMCs ensure the accuracy of press releases and manuscripts detailing study findings? How should DMCs determine when to unblind participants after a study is over if it is relevant for their medical decision-making? In this presentation, we will report preliminary results of a qualitative study of DMC members (i.e. statisticians, clinicians, and ethicists). We will highlight persistent controversies, the range of roles DMCs are expected to play in monitoring clinical trials, and variation in formal guidance about the ethical obligations of DMCs. We will also examine the question of whether and when ethicists should serve on DMCs. We will conclude by identifying critical ethical issues facing DMCs that warrant further attention.
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SARS-CoV-2, the novel coronavirus that was first reported in Wuhan, China in December 2019, has engrossed the world with immense distress. It has shattered the global healthcare system and has inflicted so much pain on humanity. COVID-19, the disease caused by a microscopic enemy, has now spread to almost all the countries in the world affecting millions of people and causing enormous casualties. World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2019. As of June 15, 2020, almost 7.70 million people have already been infected globally with 428,000 reported casualties. In the United States alone, 2.14 million people have been infected and 117,000 people have succumbed to this pandemic. A multipronged approach has been launched towards combating this pandemic with the main focus on exhaustive screening, developing efficacious therapies, and vaccines for long-term immunity. Several pharmaceutical companies in collaboration with various academic institutions and governmental organizations have started investigating new therapeutics and repurposing approved drugs so as to find fast and affordable treatments against this disease. The present communication aims at highlighting the efforts that are currently underway to treat or prevent SARS-CoV-2 infection through immunotherapy. Emphasis has been laid on discussing the approaches and platforms that are being utilized for the speedy development of therapeutic antibodies and preventive vaccines against SARS-CoV-2. The manuscript also presents a detailed discussion regarding strategy, clinical status, and timeline for the development of safe and enduring immunotherapy against SARS-CoV-2. All the details pertaining to the clinical status of each candidate have been last updated on June 15, 2020.Copyright © 2020 Bentham Science Publishers.