70 10 20655 https://socictopen.socict.org/files/original/3e6e30e1fca10661e44251d2f64394ed.pdf 05b6f3839f29e894224c292185f80aab Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A QSTR-Based Expert System to Predict Sweetness of Molecules Creator An entity primarily responsible for making the resource Cristian Rojas, Roberto Todeschini, Davide Ballabio, Andrea Mauri, Viviana Consonni, Piercosimo Tripaldi, Francesca Grisoni Description An account of the resource This work describes a novel approach based on advanced molecular similarity to predict the sweetness of chemicals. The proposed Quantitative Structure-Taste Relationship (QSTR) model is an expert system developed keeping in mind the five principles defined by the Organization for Economic Co-operation and Development (OECD) for the validation of (Q)SARs. The 649 sweet and non-sweet molecules were described by both conformation-independent extended-connectivity fingerprints (ECFPs) and molecular descriptors. In particular, the molecular similarity in the ECFPs space showed a clear association with molecular taste and it was exploited for model development. Molecules laying in the subspaces where the taste assignation was more difficult were modeled trough a consensus between linear and local approaches (Partial Least Squares-Discriminant Analysis and N-nearest-neighbor classifier). The expert system, which was thoroughly validated through a Monte Carlo procedure and an external set, gave satisfactory results in comparison with the state-of-the-art models. Moreover, the QSTR model can be leveraged into a greater understanding of the relationship between molecular structure and sweetness, and into the design of novel sweeteners. Date A point or period of time associated with an event in the lifecycle of the resource 2017 Subject The topic of the resource Sweetness, QSAR, molecular descriptors, classification, Expert System Identifier An unambiguous reference to the resource within a given context DOI: 10.3389/fchem.2017.00053 Source A related resource from which the described resource is derived Frontiers in Chemistry Publisher An entity responsible for making the resource available Frontiers Media S.A. Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Chemistry Language A language of the resource EN https://socictopen.socict.org/files/original/9d38f455e485313ca7b095ef5d5ff56b.pdf 66b803e22e9880b640633fb664d4344b Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Agricultura sostenible Description An account of the resource Dominio científico: Agricultura sostenible Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A qualidade na recuperação de dados governamentais: um estudo sobre dados de políticas públicas na internet Creator An entity primarily responsible for making the resource Ricardo César Gonçalves Sant'Ana, Fábio Mosso Moreira, Pedro Henrique Santos Bisi, Leonardo Castro Botega, José Eduardo Santarem Segundo Description An account of the resource RESUMO O uso da Internet para acessar dados governamentais é crescente e apresenta possibilidades para o cidadão acompanhar a execução das políticas públicas. No contexto das políticas públicas para o setor da agricultura, destaca-se que estas constituem um fator preponderante no desenvolvimento social e econômico,principalmente dos pequenos produtores, que, por sua vez, necessitam desse conteúdo informacional para participarem e acompanharem as ações. O governo, mediante a Lei de Acesso à Informação, é responsável por garantir a ampla divulgação dos programas governamentais, entretanto, o que se observa muitas vezes é que os dados não são disponibilizados como deveriam, tendo principalmente problemas relacionados a qualidade das bases e dos serviços de recuperação. Assim, oobjetivo da pesquisa consiste em identificar dimensões de qualidade envolvidas no acesso a dados governamentais na Internet e aplicá-las no estudo do processo recuperação dos dados do Programa Nacional de Fortalecimento da Agricultura Familiar disponíveis no portal do Banco Central. Metodologicamente, realizou-se uma revisão teórica para identificar na literatura artigos que tratam sobre a questão da qualidade de dados no contexto governamental, e, posteriormente, uma Análise de Conteúdo para identificar categorias que pudessem representar tais dimensões de forma específica para este domínio. Estas dimensões foram aplicadas no estudo do processo de recuperação de dados de uma política pública agrícola direcionada ao desenvolvimento socioeconômico dos pequenos produtores, e os resultados obtidos estabelecem uma perspectiva sobre como a questão da qualidade de dados pode ser observada no cenário estudado, bem como suas implicações para o acesso e apropriação do conteúdo. Date A point or period of time associated with an event in the lifecycle of the resource 2020 Subject The topic of the resource Pronaf, Recuperação de dados, política pública, qualidade;dados governamentais Identifier An unambiguous reference to the resource within a given context 10.1590/1981-5344/3994 Source A related resource from which the described resource is derived Perspectivas em Ciência da Informação Publisher An entity responsible for making the resource available Universidade Federal de Minas Gerais, Escola de Ciência da Informação Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Bibliography. Library science. Information resources Relation A related resource <a href="http://www.scielo.br/pdf/pci/v25n2/1413-9936-pci-25-02-103.pdf" target="_blank" rel="noreferrer noopener">http://www.scielo.br/pdf/pci/v25n2/1413-9936-pci-25-02-103.pdf</a> https://socictopen.socict.org/files/original/70ec198dff344eb12658dba859cf48d8.pdf 978f255d24ed061adc272e3f9df0877a Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A Qualitative Analysis of Implementing E-Learning during the COVID-19 Lockdown Creator An entity primarily responsible for making the resource Carlos Peñarrubia-Lozano, Manuel Segura-Berges, Manuel Lizalde-Gil, Juan Carlos Bustamante Description An account of the resource The existing literature evidences the potential of the e-learning methodology, although some call it into question. Our study aimed to analyse the real scope of applying this methodology type to a lockdown situation like that caused by COVID-19. It could provide the scientific and educational community with useful novel information on e-learning and its real adequacy for schools in pre-university educational stages. This qualitative study was designed using questionnaires with open-ended questions for students and semistructured interviews for teachers, management board members, and families of students of Primary and Secondary Education. The scripts of data collection tools were made ad hoc. The thematic analysis was carried out in accordance with the study dimensions by relating the access and use of technological resources in classrooms, implementing the e-learning methodology during face-to-face teaching, and finally knowing the effects of its application during remote teaching in the lockdown situation. The results clearly show a need to adapt and adjust the implementation of this methodology by considering not only its specificities, but also a combination of e-learning and traditional teaching methodologies can help to introduce information and communication technologies (ICT) into classrooms. To conclude, including such a methodology in the educational context can be argued for, provided that specific training is received to allow the potential of both online and traditional teaching to be leveraged. Date A point or period of time associated with an event in the lifecycle of the resource 2021 Subject The topic of the resource coronavirus, e-learning, secondary, Blended learning, primary Identifier An unambiguous reference to the resource within a given context 10.3390/su13063317 Source A related resource from which the described resource is derived Biotemas Publisher An entity responsible for making the resource available Universidade Federal de Santa Catarina Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Environmental effects of industries and plants, Renewable energy sources, Environmental sciences https://socictopen.socict.org/files/original/5bebf795d3c3318eced4b90214facaee.pdf 622aad8b9d754093c462f51faef4822f Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A Qualitative Study On Mental Distress Of Vietnamese Students In The U.S.A. In The Covid-19 Era Creator An entity primarily responsible for making the resource Ngoc Cindy Pham, Juehui Richard Shi Description An account of the resource Objective: This paper aims to examine how the COVID-19 pandemic affects the mental distress of the Vietnamese students in the USA. We explore different root causes of mental distress among international students who are away from their home country, their loved ones, and being isolated from school and community due to this outbreak. Design: In-depth interviews were conducted to probe the reasons for mental stress during the pandemic and the narrative textual analysis was subsequently performed to analyze the results. This research includes the interviews of 20 Vietnamese students in the USA during the COVID-19 era. Results: The textual analysis showed that the mental distress of these Vietnamese students were caused by limited access to on-campus facilities and activities, limited access to public services including grocery shopping, transportations, clinics, the possibility of being infected, isolated living condition due to the lockdown order, and inability to go back to the home country when wanted. Conclusions: We found that both physical attributes (e.g., living condition, internet difficulty, overwhelmed healthcare system, restricted traveling, lack of personal interaction, limited access to public services) and psychological factors (e.g., anxiety of unfamiliar teaching modality, fear of viral infection, uncertain career aspects, cultural barrier and prejudice) directly led to the mental distress of these students. Moreover, other factors such as turbulent future job markets and potential racism toward Asians in relation with “Chinese virus” may cause the mental distress of these students. Date A point or period of time associated with an event in the lifecycle of the resource 2020 Subject The topic of the resource covid-19; vietnamese students; mental distress; narrative textual analysis; racism Identifier An unambiguous reference to the resource within a given context 10.24083/apjhm.v15i3.459 Source A related resource from which the described resource is derived Asia Pacific Journal of Health Management Publisher An entity responsible for making the resource available ACHSM Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Public aspects of medicine, Medicine (General) https://socictopen.socict.org/files/original/f251378439d6a31721af10378a35d7f0.pdf f7cff904092ffcba438c0558522c876e Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Agricultura sostenible Description An account of the resource Dominio científico: Agricultura sostenible Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A questão ambiental como objeto de atuação da vigilância sanitária: uma análise da inserção das enfermeiras nesse campo El ambiente como objeto de actuación de la vigiláncia sanitaria: un análisis de la inserción de las enfermeras en ese campo The environment as a health surveillance issue: analysis of nursing activities Creator An entity primarily responsible for making the resource Maria Celeste Soares Ribeiro, Maria Rita Bertolozzi Description An account of the resource O presente estudo buscou verificar como enfermeiras que atuam na área da Vigilância Sanitária do Município de São Paulo, tratam as questões relativas ao meio ambiente na sua prática cotidiana. A sua realização foi motivada pela urgente necessidade de conservação do meio ambiente, que vem sendo defendida na agenda das políticas nacionais e internacionais. Em julho-agosto de 1999, foram obtidos depoimentos de 8 enfermeiras, os quais foram analisados segundo técnica de análise de discurso. O desenvolvimento do estudo evidenciou que, em geral, as ações realizadas por essas enfermeiras não têm como finalidade a conservação ambiental, restringindo-se a ações de caráter focal e emergencial.El presente trabajo buscó verificar cómo se ubican las cuestiones relativas al medio ambiente en la práctica diaria de las enfermeras que trabajan en la vigilancia sanitaria. Tal preocupación tiene su razón de ser en el hecho de que la conservación del ambiente hace parte de la agenda nacional e internacional. Entre julio y agosto de 1999 fueron tomados los testimonios de ocho enfermeras, los cuales fueron estudiados mediante la técnica de análisis de discurso. Se concluye que, en general, las acciones desarrolladas por esas enfermeras no tienen como finalidad la conservación ambiental, restringiéndose a intervenciones de carácter puntual y emergencial.The fact that the need for environmental conservation has been on the national and international agenda determined the development of this study, which aims to examine how the environment is an issue for nurses working in health surveillance services, according to their testimonies. From July to August 1999, eight female nurses described their routine. Their reports were studied by means of the discourse analysis technique. It was concluded that, in general, their actions were not aimed at environmental conservation and were limited to factual and emergency issues. Date A point or period of time associated with an event in the lifecycle of the resource 2004 Subject The topic of the resource Ambiente, Enfermagem, Enfermería, Health Surveillance, Nursing, Vigilancia Sanitaria, environment, meio ambiente Identifier An unambiguous reference to the resource within a given context 10.1590/S0104-11692004000500006 Source A related resource from which the described resource is derived Revista Latino-Americana de Enfermagem Publisher An entity responsible for making the resource available Universidade de São Paulo Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Nursing Relation A related resource <a href="http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0104-11692004000500006" target="_blank" rel="noreferrer noopener">http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0104-11692004000500006</a> https://socictopen.socict.org/files/original/a20d59706635819fd35713e9c884cb01.pdf 73d75f543be57757e993f32ce5dbdc58 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Agricultura sostenible Description An account of the resource Dominio científico: Agricultura sostenible Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A questão ambiental na origem do problema agrário brasileiro e o caso da região Sul The environmental problem in the basis of the agrarian transformations in Brazil: the case of the South region Creator An entity primarily responsible for making the resource Humberto Miranda do Nascimento Description An account of the resource A especificidade do processo de apropriação privada de terras públicas no Brasil, após 1850, é o ponto de origem dos problemas ambientais atuais no espaço rural, isso porque foi desse período em diante que a ausência de limites ambientais se tornou a regra principal da aliança entre a concentração fundiária e o progresso técnico aplicado à agricultura, comprometendo dramaticamente outras formas de acesso, bem como o uso produtivo ou não produtivo das terras e seus recursos naturais. O estudo de caso realizado na região sudoeste do Paraná, no Sul do Brasil, no entanto, demonstra que, apesar de uma estrutura agrária mais democrática, a regra de ausência de limites ambientais também é reiterada. Naquela região, o impulso básico à degradação ambiental deve-se ao fato de as estratégias de reprodução da agricultura familiar estarem estreitamente associadas aos imperativos do mercado exportador de grãos.The characteristics of the private appropriation of lands of public domain in Brazil pos 1850 are the root of the current environmental problems in rural areas. Ever since, the absence of environmental boundaries has been the main rule for the links between land concentration and technical progress in agriculture, jeopardizing other ways of access and then use of lands and their natural resources. We analyze the case of the Southeast region in the State of Paraná, Brazil. This study suggests that despite of having a more democratic agrarian structure than Brazil as a whole, the Southeast of Paraná yet presents social and economical vulnerability and increasing levels of environmental risks as new cases of soil erosion are registered. This is due to the fact that the reproduction strategies of family agriculture are closely associated with the imperatives of the grain export market. Date A point or period of time associated with an event in the lifecycle of the resource 2008 Subject The topic of the resource Agrarian problem, Natural Resources, Paraná, Public Domain, Questão agrária, Recursos Naturais, Southeast of Paraná, Sudoeste, Terras públicas Identifier An unambiguous reference to the resource within a given context 10.1590/S0104-06182008000200005 Source A related resource from which the described resource is derived Economia e Sociedade Publisher An entity responsible for making the resource available Universidade Estadual de Campinas Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Economics as a science, Economic history and conditions Relation A related resource <a href="http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0104-06182008000200005" target="_blank" rel="noreferrer noopener">http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0104-06182008000200005</a> https://socictopen.socict.org/files/original/2097cd3b5a5892c3b2c6ae5ca832b06a.pdf 84479a728a13eaa901b7cbdb501d3ccd Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Agricultura sostenible Description An account of the resource Dominio científico: Agricultura sostenible Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A questão ecológica: entre a ciência e a ideologia/utopia de uma época Creator An entity primarily responsible for making the resource Silva Elmo Rodrigues da, Schramm Fermin Roland Description An account of the resource A problemática atual da questão ambiental remete-nos à discussão histórica da racionalidade científica, sobretudo nas sociedades ocidentais contemporâneas, onde o conflito entre a relação homem/meio natural fica evidenciado. Pretendendo dar conta deste conflito, a ecologia constituída como disciplina científica destaca-se como um campo problemático da ciência que busca integrar diversas disciplinas em torno de si. Alguns movimentos sociais, orientando-se por uma 'visão ecologizada' (ecossistêmica) de mundo, partem para denunciar os impactos ambientais oriundos, dentre outros, do modelo tecno-industrial altamente poluidor, consumidor dos recursos naturais e gerador da atual desordem global da biosfera. Esses movimentos, sendo orientados por éticas diferenciadas, reivindicam mudanças do quadro social e ambiental da sociedade atual a fim de garantir as necessidades das futuras gerações. Date A point or period of time associated with an event in the lifecycle of the resource 1997 Subject The topic of the resource ecología, meio ambiente, ética ambiental Source A related resource from which the described resource is derived Cadernos de Saúde Pública Publisher An entity responsible for making the resource available Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Medicine, Public aspects of medicine Relation A related resource <a href="http://www.scielosp.org/scielo.php?script=sci_arttext&amp;pid=S0102-311X1997000300002" target="_blank" rel="noreferrer noopener">http://www.scielosp.org/scielo.php?script=sci_arttext&amp;pid=S0102-311X1997000300002</a> https://socictopen.socict.org/files/original/2091f0f3a6c03320edf11e479a05ff71.pdf 84479a728a13eaa901b7cbdb501d3ccd Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Agricultura sostenible Description An account of the resource Dominio científico: Agricultura sostenible Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A questão ecológica: entre a ciência e a ideologia/utopia de uma época The ecological issue: science and ideology, or the utopia of a time Creator An entity primarily responsible for making the resource Elmo Rodrigues da Silva, Fermin Roland Schramm Description An account of the resource A problemática atual da questão ambiental remete-nos à discussão histórica da racionalidade científica, sobretudo nas sociedades ocidentais contemporâneas, onde o conflito entre a relação homem/meio natural fica evidenciado. Pretendendo dar conta deste conflito, a ecologia constituída como disciplina científica destaca-se como um campo problemático da ciência que busca integrar diversas disciplinas em torno de si. Alguns movimentos sociais, orientando-se por uma 'visão ecologizada' (ecossistêmica) de mundo, partem para denunciar os impactos ambientais oriundos, dentre outros, do modelo tecno-industrial altamente poluidor, consumidor dos recursos naturais e gerador da atual desordem global da biosfera. Esses movimentos, sendo orientados por éticas diferenciadas, reivindicam mudanças do quadro social e ambiental da sociedade atual a fim de garantir as necessidades das futuras gerações.Our modern concern over the environment brings us to the historical discussion of Scientific Rationalism, principally in contemporary western society, where the conflict between Man and the Natural World is at its greatest. In an attempt to solve this conflict, Ecology, a field of science, stands out riddled with problems, seeking to draw subjects from other fields into its own. Following an 'ecologized world view' (Ecosystemics), some social currents denounce the environmental impact of, technological and industrial models, highly pollutant and dependent on natural resources, generating the contemporary disorder in our biosphere. These movements, following different schools of thought, demand changes in society, taking into consideration the present and future state of the environment. Date A point or period of time associated with an event in the lifecycle of the resource 1997 Subject The topic of the resource ecology, ecología, environment, environmental ethics, meio ambiente, ética ambiental Identifier An unambiguous reference to the resource within a given context 10.1590/S0102-311X1997000300002 Source A related resource from which the described resource is derived Cadernos de Saúde Pública Publisher An entity responsible for making the resource available Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Medicine, Public aspects of medicine Relation A related resource <a href="http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0102-311X1997000300002" target="_blank" rel="noreferrer noopener">http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0102-311X1997000300002</a> https://socictopen.socict.org/files/original/27793a301bafa8040417d2d387716589.pdf 33116e4003f192c3e548cd7924c4d7b1 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial Creator An entity primarily responsible for making the resource John G. Laffey, Noel G. McElvaney, Natalie L. McEvoy, Jennifer L. Clarke, Oliver J. Mc Elvaney, Oisin F. Mc Elvaney, Fiona Boland, Deirdre Hyland, Pierce Geoghegan, Karen Donnelly, Oisin Friel, Ailbhe Cullen, Ann M. Collins, Daniel Fraughen, Ignacio Martin-Loeches, Martina Hennessy, Gerard F. Curley Description An account of the resource Abstract Objectives The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs). Trial design Phase 2, randomised, double-blind, placebo-controlled, pilot trial. Participants The study will be conducted in Intensive Care Units in hospitals across Ireland. Patients with a laboratory-confirmed diagnosis of SARS-CoV-2-infection, moderate to severe ARDS (meeting Berlin criteria for a diagnosis of ARDS with a PaO2/FiO2 ratio 18 years of age and requiring invasive or non-invasive mechanical ventilation. All individuals meeting any of the following exclusion criteria at baseline or during screening will be excluded from study participation: more than 96 hours has elapsed from onset of ARDS; age < 18 years; known to be pregnant or breastfeeding; participation in a clinical trial of an investigational medicinal product (other than antibiotics or antivirals) within 30 days; major trauma in the prior 5 days; presence of any active malignancy (other than nonmelanoma skin cancer) which required treatment within the last year; WHO Class III or IV pulmonary hypertension; pulmonary embolism prior to hospital admission within past 3 months; currently receiving extracorporeal life support (ECLS); chronic kidney disease receiving dialysis; severe chronic liver disease with Child-Pugh score > 12; DNAR (Do Not Attempt Resuscitation) order in place; treatment withdrawal imminent within 24 hours; Prisoners; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; IgA deficiency. Intervention and comparator Intervention: Either a once weekly intravenous infusion of Prolastin® at 120mg/kg of body weight for 4 weeks or a single dose of Prolastin® at 120mg/kg of body weight intravenously followed by once weekly intravenous infusion of an equal volume of 0.9% sodium chloride for a further 3 weeks. Comparator (placebo): An equal volume of 0.9% sodium chloride intravenously once per week for four weeks. Main outcomes The primary effectiveness outcome measure is the change in plasma concentration of IL-6 at 7 days as measured by ELISA. Secondary outcomes include: safety and tolerability of Prolastin® in the respective groups (as defined by the number of SAEs and AEs); PaO2/FiO2 ratio; respiratory compliance; sequential organ failure assessment (SOFA) score; mortality; time on ventilator in days; plasma concentration of alpha-1 antitrypsin (AAT) as measured by nephelometry; plasma concentrations of interleukin-1β (IL-1β), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TNF receptor 1 (sTNFR1, a surrogate marker for TNF-α) as measured by ELISA; development of shock; acute kidney injury; need for renal replacement therapy; clinical relapse, as defined by the need for readmission to the ICU or a marked decline in PaO2/FiO2 or development of shock or mortality following a period of sustained clinical improvement; secondary bacterial pneumonia as defined by the combination of radiographic findings and sputum/airway secretion microscopy and culture. Randomisation Following informed consent/assent patients will be randomised. The randomisation lists will be prepared by the study statistician and given to the unblinded trial personnel. However, the statistician will not be exposed to how the planned treatment will be allocated to the treatment codes. Randomisation will be conducted in a 1:1:1 ratio, stratified by site and age. Blinding (masking) The investigator, treating physician, other members of the site research team and patients will be blinded to treatment allocation. The clinical trial pharmacy personnel and research nurses will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set to maintain blinding. Numbers to be randomised (sample size) A total of 36 patients will be recruited and randomised in a 1:1:1 ratio to each of the trial arms. Trial status In March 2020, version 1.0 of the trial protocol was submitted to the local research ethics committee (REC), Health Research Consent Declaration Committee (HRCDC) and the Health Products regulatory Authority (HPRA). REC approval was granted on April 1st 2020, HPRA approval was granted on April 24th 2020 and the HRCDC provided a conditional declaration on April 17th 2020. In July 2020 a substantial amendment (version 2.0) was submitted to the REC, HRCDC and HPRA. Protocol changes in this amendment included: the addition of trial sites; extending the duration of the trial to 12 months from 3 months; removal of inclusion criteria requiring the need for vasopressors; amendment of randomisation schedule to stratify by age only and not BMI and sex; correction of grammatical error in relation to infusion duration; to allow for inclusion of subjects who may have been enrolled in a clinical trial involving either antibiotics or anti-virals in the past 30 days; to allow for inclusion of subjects who may be currently enrolled in a clinical trial involving either antibiotics or anti-virals; to remove the need for exclusion based on alpha-1 antitrypsin phenotype; removal of mandatory isoelectric focusing of plasma to confirm Pi*MM status at screening; removal of need for mandatory echocardiogram at screening; amendment on procedures around plasma analysis to reflect that this will be conducted at the central site laboratory (as trial is multi-site and no longer single site); wording amended to reflect that interim analysis of cytokine levels taken at 7 days may be conducted. HRCDC approved version 2.0 on September 14th 2020, and HPRA approved on October 22nd 2020. REC approved the substantial amendment on November 23rd. In November 2020, version 3.0 of the trial protocol was submitted to the REC and HPRA. The rationale for this amendment was to allow for patients with moderate to severe ARDS from SARS-CoV-2 with non-invasive ventilation. HPRA approved this amendment on December 1st 2020 and the REC approved the amendment on December 8th 2020. Patient recruitment commenced in April 2020 and the last patient will be recruited to the trial in April 2021. The last visit of the last patient is anticipated to occur in April 2021. At time of writing, patient recruitment is now complete, however follow-up patient visits and data collection are ongoing. Trial registration EudraCT 2020-001391-15 (Registered 31 Mar 2020). Full protocol The full protocol (version 3.0 23.11.2020) is attached as an additional file accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Date A point or period of time associated with an event in the lifecycle of the resource 2021 Subject The topic of the resource covid-19, SARS-CoV-2, acute respiratory distress syndrome, ARDS, Randomised controlled trial, protocol Identifier An unambiguous reference to the resource within a given context 10.1186/s13063-021-05254-0 Source A related resource from which the described resource is derived Epidemiology and Health Publisher An entity responsible for making the resource available Korean Society of Epidemiology Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Medicine (General) https://socictopen.socict.org/files/original/0890d7d055416d56d94c35869d570f3d.pdf 3d8c3d0d7c54ccf7d22d6b7b86a0b36a Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A Randomized open label parallel group pilot study to evaluate efficacy of Ayurveda interventions in the management of Asymptomatic and Mild COVID-19 patients-Experiences of a Lucknow based Level 2 hospital of Uttar Pradesh, India. Creator An entity primarily responsible for making the resource Adil Rais, Devendra Singh Negi, Amita Yadav, Himanshu Arya, Ramji Verma, R Galib, Absar Ahmad, Mahendra Kumar Yadav, P N Ahirwar Description An account of the resource Sars Cov-2 has emerged as a global threat since its onset in December 2019. India has also been severely affected by the dreadful Corona Virus and is currently battling one of the worst pandemics of history. WHO and the world medical fraternity are putting their efforts to materialize a treatment or vaccine for this novel virus. A randomized open label parallel group study was designed in a Lucknow based level 2 COVID hospital to evaluate the efficacy of Ayurvedic interventions in the management of asymptomatic and mild COVID 19 patients. To evaluate the efficacy of Ayurveda in the management of mildly affected COVID-19 patients. The current trial was an open label randomized 10-day study. Total 120 asymptomatic and/or mild Covid-19 positive patients fulfilling inclusion criteria were randomly grouped into three. RT-PCR of all the patients were done on 5th, 7th and on 10th day respectively. The observations were noted and results were analyzed statistically. Kruskal-Wallis test and Wilcoxon Sign rank test were used for data analysis where applicable. Improvement in symptoms, enhancement in Agni and recovery from COVID infection was observed. The results obtained were encouraging and showed better viral clearance and control of symptom progression in the patients placed on Ayurvedic medications. The promising results in the study showed that an approach involving Ayurveda can be helpful for the management of the mild COVID-19 patients. Ayurveda can be used to limit community spread and check disease progression to a more appalling state. Trial was registered with Clinical Trials Registry- India (CTRI registration number: CTRI/2020/06/025800. Date A point or period of time associated with an event in the lifecycle of the resource 2021 Subject The topic of the resource immunity, covid-19, Ayurveda, randomized trial, Agni Identifier An unambiguous reference to the resource within a given context 10.1016/j.jaim.2020.12.013 Source A related resource from which the described resource is derived Journal of Ayurveda and integrative medicine