BACKGROUND REVIEW OF THE IMPACT OF ONLINE SALES ON SMEs IN LATIN AMERICA IN TIMES OF COVID-19. CASE STUDY: PORTOVIEJO, ECUA

The commercial strategies of the small businesses of Alajuela Street in the Portoviejo Canton of Manabí in Ecuador in times of COVID-19 have had different impacts. This article seeks to explore and disseminate the main business strategies of SMEs in Latin America and their impacts of these business strategies on small business sales. A case study is proposed from one of the cantons of Ecuador. To carry out the research, the consultation of specialized bibliography, the survey, direct observation and statistical processing are used. As main re-sults, it is obtained that in 99% of the cases, the merchants who applied online marketing strategies in periods of Covid-19 had a positive impact on their income, a behavior similar to that of studies in the Latin American field. 74% of those surveyed decided to keep offering the same kind of item or product during the pandemic and 18% decided to switch products to food. 94.1% of businesses were affected by COVID-19. © 2023, University of Cienfuegos, Carlos Rafael Rodriguez. All rights reserved.

Procalcitonin combined to point of care molecular respiratory panel testing for antibiotic stewardship in the emergency room: the PROARRAY study

Introduction: Molecular syndromic respiratory panel (RP) or procalcitonin (PCT)-driven algorithms have reported conflicting efficacy for antibiotic ATB) stewardship in LRTI. We hypothesized that combining real-time PCT measurement and virus identification would reduce ATB exposition in LRTI suspicions presenting to the emergency department (ED). Method(s): PROARRAY study is a prospective, randomized interventional trial, conducted in the adult ED of an academic 1600-bed hospital. Patients attending the ED with a suspicion of LRTI were randomized into the intervention arm (systematic PCT measurement and point of care BIOFIRE RP2plus (then 2.1) testing, with the recommendation to withhold or withdraw ATB if PCT < 0.25 mug/L and/or identification of a virus) or a standard of care (SOC) arm. The primary endpoint was the duration of antibiotic exposure in the first 28 days. Result(s): 451 patients were randomized (intervention: 225, SOC: 226), mean age 62.5 +/- 19.4 years, hospitalization rate 59.9%, mean length of stay 7.4 +/- 8.4 days. Main diagnoses were CAP (n = 129), COVID-19 (n = 91), AECOPD (n = 31). The BIOFIRE RP2.1plus identified at least one viral species in 112 patients (49.8%). The duration of ATB exposition in ITT population was 6.00 [0.00;9.00] and 5.00 [0.00-9.00] days in the SOC and interventional arm respectively (p = 0.71). ATB was started in 31.3% and 34.1% respectively (p = 0.54). ATB exposure was below 6 days in 100 (47.2%) and 108 patients (50.59%) respectively (p = 0.58). Conclusion(s): Displaying real-time PCT and RP results failed to significantly reduce the ATB exposition in LRTI suspicions. However, the ATB duration and rate of initiation were already low in SOC arm, which comprised PCT measurement in routine in our ED. Routine PCT measurement probably participated to the lower median ATB duration (6.0 days) than hypothesized (9.0 days) and argues for the main contribution of PCT in ATB stewardship. Moreover, as the intervention was done at ED's level, we did not control for ATB stewardship in wards for inpatients.

Incidental tomographic findings in patients with a Confirmed Diagnosis of COVID-19: An Observational Study

Objective: Describe incidental tomographic in the sample, correlating them with risk factors for chest diseases and sociodemographic data. Method(s): This is a retrospective and observational study covering 162 patients admitted to the COVID sector of the HU/UFJF, from April 1, 2020, to July 7, 2021, with a confirmed laboratory diagnosis of COVID-19. The variables were described in absolute and relative frequencies. The comparison of the correlation between the outcome variable (the tomographic findings) for independent samples was performed using Pearson's chi-square test (without correction) or Fisher's test when relevant. Result(s): Of the 162 patients, 15.4% had a solitary pulmonary nodule;14.8% had multiple pulmonary nodules;1.8%, lung mass;3.1%, mediastinal mass, and 9.3% had mediastinal adenomegaly. Findings such as excavations, pleural effusion, emphysema, PTE, pneumothorax, chronic interstitial disease, cavitation, aneurysms, and significant atheromatosis, classified in this study in the "Other" category showed impressive results, with an overall prevalence of 81.5%. This study demonstrated that 34% of patients had two or more types of incidental CT findings and that 88.3% of patients had at least some type of incidental CT finding. Conclusion(s): The pandemic of SARS-CoV-2 infections has brought a series of challenges and lessons learned to healthcare teams around the world. The massive implementation of highly sensitive diagnostic methods, such as chest tomography, ends up bringing an additional challenge, which is to deal with incidental findings, making good clinical reasoning necessary to avoid unnecessary investigations and not leave without diagnosis and treatment of diseases in early and asymptomatic stages.Copyright © 2023 Faculdade de Medicina de Ribeirao Preto - U.S.P.. All rights reserved.

Which biomarker(s) to predict worsening of SARS-CoV2 infection? An ancillary study from the COVIDeF cohort

Introduction: COVID-19 has been responsible for millions of deaths and intensive care unit (ICU) admissions all over the world. Identifying the patients at risk of developing a severe form is crucial for an optimized orientation and allocation of resources. The main objective of our study was to identify among a selection of biomarkers, those predictive of short term worsening in COVID-19. Method(s): This is an ancillary study using clinical data and collected biobanking from the multicentric cohort study COVIDeF, which included prospectively from March 31th 2020 to March 30th 2021, patients admitted with a suspected Sars-CoV2 infection in the Assistance- Publique-Hopitaux de Paris network, France. Patients with confirmed COVID-19 were divided in 2 groups: a severe (ICU admission or invasive or non-invasive ventilation or ARDS or death) and a control group (no worsening). The routine blood tests and following biomarkers: troponin, C Reactive Protein (CRP), procalcitonin, Mild- Regional pro-Adrenomedulin (MR-proADM), pro-endothelin, SuPAR, NT-proBNP, calprotectin, PF4, D-dimers, were measured in plasma or serum and compared between both groups using a conditional logistic regression. Result(s): Among the 1040 first patients included in the COVIDEF cohort, we selected 512 patients having a blood sample drawn at admission before worsening, of which 60 secondarily worsened (severe group). The mean age was 59.5 (+/- 19.5) years and 50.2% were females. Among the biomarkers tested, three were independently associated with worsening: CRP (mg/l) OR 1.01 [IC 1.01-1.02], procalcitonin (ng/ml) OR 0.4428 [0.21-0.95] and MR-proADM (pg/ml) OR 3.012 [1.06-8.53]. Conclusion(s): Among a selection of biomarkers of interest, MRproADM appears to best identify at admission COVID-19 patients at risk of worsening. Future interventional studies should test the efficacy and security of this biomarker to rule-in and rule-out severe outcome and the usefulness for allocating resources.

Oxidative stress in diverse clinical conditions of SARS-CoV-2 Cuban hospitalized patients

Context: COVID-19 related to SARS-CoV-2 infection generates inflammation with increased reactive oxygen species production. Drug treatment and others factors could influence systemic oxidative stress during pathogenic insult. Aims: To determine the redox status in COVID-19 patients with different clinical conditions and explore the relationship between redox and hematological hemochemical variables. Methods: In this comparative longitudinal study, blood samples were drawn from 160 individuals divided into four groups: COVID-19 asymptomatic, COVID-19 symptomatic (low and moderate symptoms), COVID-19 convalescent, and presumable healthy subjects. Demographic, redox, hematological, and hemochemical indices were assessed. Statistical analyses compared the median values of each variable and explored individual, simultaneous indices, and multivariate alteration. Results: Relative to the healthy group, acute COVID-19, and convalescent groups had significant differences in global damage indices and antioxidant status (p<0.05). The convalescent group showed significantly higher damage (malondialdehyde, advanced oxidation protein products, nitric oxide) and lower antioxidant enzymatic activities and glutathione concentration compared to other groups (p<0.05). Global modification of redox indices showed that more than 80% of studied individuals in acute conditions had simultaneous detrimental differences compared to a healthy status. The discriminant analysis permitted obtaining two canonical functions (p< 0.05) that reflect 98% of redox variables with 95% of variances with successful case classifications. Conclusions: These results corroborate that oxidative stress occurred in different COVID-19 and post-acute conditions with different molecular alterations of redox indices. Redox diagnosis should be considered in early diagnosis and treatment of infection, which would be worthwhile to conduct a more comprehensive study and management of disease evolution. © 2023 Journal of Pharmacy & Pharmacognosy Research.

Etrasimod for the treatment of ulcerative colitis: analysis of infection rates from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 clinical trials

Background: Infections are an important safety concern in patients with IBD and may be due to its therapies, such as corticosteroids. Etrasimod is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 (S1P1,4,5) modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). The biologic effect of etrasimod leads to selective and reversible lymphocyte retention in lymph nodes with a decrease in peripheral lymphocyte count. We report the infection events from the phase 3 ELEVATE programme. Method(s): Infection events were evaluated in the pivotal UC pooled safety analyses set comprising two phase 3 studies: ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369). Subjects (16- 80 years) with moderately to severely active UC were randomised 2:1 to once-daily etrasimod 2 mg or placebo (PBO). We report the n (%) and exposure-adjusted incidence rate (EAIR) of infections including serious infections, severe infections, opportunistic infections (including tuberculosis), and herpes infections. Infections were considered adverse events of special interest (AESI) if they were severe (>= CTCAE Grade 3), were opportunistic infections, or were herpes zoster or herpes simplex infections. Result(s): From the pooled ELEVATE UC 12 and ELEVATE UC 52 trials, 527 subjects received >=1 dose of etrasimod 2 mg (265.6 subject-years of exposure) and 260 subjects were randomised to PBO (103.0 subjectyears of exposure). Infections were similar between treatment groups (etrasimod: 99 [18.8%], EAIR=0.41;PBO: 46 [17.7%], EAIR=0.52). The most frequent infections in both groups were COVID-19, urinary tract infections, and nasopharyngitis (Table 1). Serious infections occurred in 3 (0.6%) subjects in the etrasimod arm (EAIR=0.01) and 5 (1.9%) in PBO arm (EAIR=0.05). Two cases of herpes zoster were reported in each treatment group (etrasimod: 0.4%, EAIR<0.01;PBO: 0.8%, EAIR=0.02);these were localised and nonserious. One opportunistic infection was reported in each arm (etrasimod: Subject withdrew from the study on day 20, the AE of Cytomegalovirus infection [Grade 2] was reported on day 36;PBO: Tuberculosis [Grade 2]). Overall, 3 cases of infection led to discontinuation: 2 in the etrasimod arm (both mild) and 1 in the PBO arm (Table 2). No subject with an absolute lymphocyte count <0.2x109/L subsequently reported a serious/ severe or opportunistic infection. There were no deaths. Downloaded from https://academic.oup.com/ecco-jcc/article/17/Supplement-1/i689/7010119 by guest on 04 February 2023 Sample output to test PDF Combine only i690 Poster presentations In these trials, etrasimod-treated subjects reported no in-crease in infections relative to PBO. Serious infections and herpes zoster were more commonly reported in the PBO-treated group. Longer-term follow-up data from the ongoing 5-year open-label extension will fur-ther characterize the etrasimod safety profile.

Long-term safety of 3 years of ozanimod in moderately to severely active ulcerative colitis: an interim analysis of the True North open-label extension

Background: The phase 3, randomised True North (TN) study demonstrated the efficacy and safety of ozanimod for up to 52 weeks in patients (pts) with moderately to severely active ulcerative colitis (UC). The ongoing TN open-label extension (OLE) aims to assess the long-term efficacy and safety of ozanimod in UC. This analysis evaluated the cumulative long-term safety of ozanimod in these studies, which included pts with up to ~3 years of treatment exposure. Method(s): In TN, pts were randomised to once-daily ozanimod 0.92 mg or placebo, or to open-label ozanimod for a 10-week induction period. Ozanimod clinical responders were rerandomised at Week 10 to ozanimod or placebo in the maintenance period through Week 52. TN pts were eligible to enrol in the OLE and receive ozanimod if they did not achieve clinical response at the end of induction (Week 10), lost response during maintenance, or completed maintenance at Week 52. This interim analysis of the TN OLE (data cutoff: 10 January 2022) included all pts who entered the OLE from TN (n=823). Safety was monitored from the first dose of ozanimod in TN and throughout the subsequent OLE. Exposureadjusted incidence rates per 100 patient-years (PY) were calculated. Result(s): The average age of TN OLE study participants was 41.7 years (+/-13.6), 41% were female, 62% had left-sided UC disease, and 35% had prior exposure to tumor necrosis factor inhibitors. Total PY exposure to ozanimod was 2219 years (mean [SD] exposure = 2.7 [1.6]). The most frequent treatment-emergent adverse events (TEAEs) reported through OLE Week 94 (up to 146 weeks of continuous treatment) are listed in the Table. Most TEAEs were nonserious;TEAEs leading to discontinuation were uncommon. Bradycardia was reported in 3 pts (0.4%;EAIR 0.1/100 PY;2 in TN and 1 in OLE;no pts were discontinued from treatment). Macular edema was reported in 2 (0.2%;EAIR 0.1/100 PY) pts. Reductions in ALC were common (470 [57.1%] had ALC < 500 cells/mm3), as previously described, but ALC reductions were not associated with the occurrence of TEAEs. Malignancies were uncommon (n=13 [1.6%];EAIR 0.6/100 PY), and included 6 basal cell carcinomas and 3 colorectal neoplasms. Two deaths were reported: 1 due to COVID-19 and 1 sudden death. Investigators deemed both to be unrelated to treatment. Ozanimod was not associated with an increased risk of ischemic heart disease or thromboembolic events. Conclusion(s): Long-term exposure to ozanimod for up to 3 years was well tolerated in pts with moderately to severely active UC. No new safety signals were observed with long-term ozanimod use in UC (2219 PY exposure). Safety findings are consistent with previous reports from the UC and multiple sclerosis development programs (>16,512 PY exposure). (Table Presented).

Incidence and risk factors for moderate/severe COVID-19 in rheumatic diseases patients on hydroxychloroquine: a 24-week prospective cohort

Objective To evaluate the incidence of COVID-19 and its main outcomes in rheumatic disease (RD) patients on hydroxychloroquine (HCQ) compared to household cohabitants (HC).Methods This is a 24-week nationwide prospective multi-centre cohort with a control group without RD and not using HCQ. All participants were monitored through scheduled phone interviews performed by health professionals. Details regarding COVID-19 symptoms, and epidemiological, clinical, and demographic data were recorded on a specific web-based platform. COVID-19 was defined according to the Brazilian Ministry of Health criteria and classified as mild, moderate or severe.Results A total of 9,585 participants, 5,164 (53.9%) RD patients on HCQ and 4,421 (46.1%) HC were enrolled from March 29th, 2020 to September 30th, 2020, according to the eligibility criteria. COVID-19 confirmed cases were higher in RD patients than in cohabitants [728 (14.1%) vs. 427 (9.7%), p<0.001] in a 24-week follow-up. However, there was no significant difference regarding outcomes related to moderate/ severe COVID-19 (7.1% and 7.3%, respectively, p=0.896). After multiple adjustments, risk factors associated with hospitalisation were age over 65 (HR=4.5;95%CI 1.35-15.04, p=0.014) and cardiopathy (HR=2.57;95%CI 1.12-5.91, p=0.026). The final survival analysis demonstrated the probability of dying in 180 days after a COVID-19 diagnosis was significantly higher in patients over 65 years (HR=20.8;95%CI 4.5-96.1) and with 2 or more comorbidities (HR=10.8;95%CI 1.1-107.9 and HR=24.8;95%CI 2.5-249.3, p=0.006, respectively).Conclusion Although RD patients have had a higher COVID-19 incidence than individuals from the same epidemiological background, the COVID-19 severity was related to traditional risk factors, particularly multiple comorbidities and age, and not to underlying RD and HCQ.

Comparativo De Diagnostico E Mortalidade Em Idosos Por Leucemias No Estado Do Parana Antes E Depois Da Pandemia De Covid-19

Introducao: A pandemia de COVID-19, causada pelo SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) trouxe um desafio para a populacao geral, sem condicoes de qualquer tipo de planejamento, porem sendo evidente o maior impacto em paises subdesenvolvidos como o Brasil, que apresentava capacidade mais limitada para lidar com casos criticos, levando ao colapso dos sistemas de saude em varias localidades. Entao, considerando que a febre e um dos principais sintomas de COVID-19 e tambem um sintoma comum nas leucemias e tambem considerando que a populacao idosa envolve uma maior complexidade devido sua fragilidade e multicomorbidades, e valido a analise no diagnostico e na mortalidade pelas leucemias comparando com ano pre-pandemico. Objetivos: Analisar, atraves dos dados disponiveis publicamente no Departamento de Informatica do Sistema Unico de Saude (DATASUS) e no Sistema de Informacao de Mortalidade (SIM), do ano de 2020, o impacto da pandemia de COVID-19 no diagnostico e mortalidade de leucemias no estado do Parana e comparar com o mesmo periodo de 2019, ultimo ano antes da pandemia. Material e Metodos: Constituiu-se de estudo transversal e descritivo. A populacao alvo foi de pacientes, de faixa etaria maior que 60 anos, com diagnostico de leucemia, firmado no estado do Parana, no periodo de 2019, ano pre-pandemia, e no ano seguinte, em 2020, primeiro apos a pandemia de COVID-19. Resultados: Em 2019, o estado do Parana registrou 198 novos casos de leucemia em idosos, sendo a maioria dado na faixa etaria entre 60 e 64 anos. No mesmo ano, foram registrados 303 obitos tendo como causa a leucemia, a maioria deles em pacientes com 80 anos ou mais. Ja em 2020, o Estado registrou 171 novos casos de leucemia, novamente com a maioria entre 60 e 64 anos. Os obitos foram contabilizados em 305, sendo a maioria na faixa etaria de 70 a 79 anos. Discussao: O numero de diagnosticos no estado do Parana reduziu apos o inicio da pandemia de COVID-19, semelhante a outros lugares do mundo com mesmo comportamento, tendo explicacao baseada talvez no respeito dos pacientes ao isolamento social e ao colapso dos sistemas de saude que necessitaram realocar recursos e funcionarios para o atendimento direto das sindromes respiratorias. A mortalidade parece nao ter sido afetada no Estado, apesar de pacientes idosos serem mais vulneraveis as complicacoes de COVID-19 e a um maior numero de internacoes, motivos pelos quais os pacientes mais idosos poderiam ter um atraso no inicio da terapia ou aumento na mortalidade por leucemias no periodo apos inicio da pandemia. Conclusao: Faz-se necessario, entao, manutencao da atencao com o diagnostico de leucemias na populacao idosa, mas tambem cautela em relacao a morbidade causada por esta, considerando maior vulnerabilidade dessa classe e maior susceptibilidade ao virus de COVID-19, que pode levar a atrasos e suspensao de esquemas de tratamento. Copyright © 2022

O Impacto Da Pandemia De Covid-19 No Diagnostico De Neoplasias Hematologicas No Estado Da Paraiba: Um Comparativo De Tres Anos

Introducao: Os canceres sao doencas geneticas cujo fenotipo maligno resulta de uma alteracao que e transmitida da celula alterada para suas celulas filhas, rompendo uma serie de barreiras fisiologicas para perpetuar. Atualmente, o cancer e encarado como um problema de saude publica em nivel global e, como outras doencas de curso menos agudo, o diagnostico e o tratamento do cancer tambem foram afetados pela pandemia de COVID-19 (coronavirus disease). Objetivos: Analisar, atraves dos dados disponiveis publicamente no Departamento de Informatica do Sistema Unico de Saude (DATASUS), dos anos de 2020 e 2021, o impacto da pandemia de COVID-19 no diagnostico de neoplasias malignas no estado da Paraiba e comparar com os mesmos periodos de 2019, ultimo ano antes da pandemia. Material e Metodos: Constituiu-se de estudo transversal e descritivo. A populacao alvo foi de pacientes, de todas as faixas etarias, com diagnostico de neoplasia hematologica, firmado no estado da Paraiba, no periodo de 2019, ano pre-pandemia, e no bienio 2020-2021, anos apos a pandemia de COVID-19. Resultados: Em 2019 a Paraiba registrou 403 novos casos de neoplasias hematologicas, sendo 213 no sexo masculino (52,8%). Os tipos mais comuns foram os linfomas nao-Hodgkin, correspondendo a 28,53%, seguido pelas leucemias (24,56%). Quanto ao estadiamento, a maioria dos diagnosticos foi no estagio II (11,6%), com o campo "Ignorado" correspondendo a 59,8%. O tempo medio entre o diagnostico e o inicio do tratamento foi menor que 30 dias (36,22%). Ja em 2020, o Estado registrou 439 novos casos, sendo 234 no sexo masculino (53,3%). Neste ano, os tipos mais comuns foram novamente os linfomas nao-Hodgkin, correspondendo a 32,11%, seguido pelas leucemias (28,7%). O estadiamento se deu no estagio 1 em sua maioria, correspondendo a 14,57%, com o campo ignorado neste ano tendo atingido a marca de 57,4%. O tempo medio entre o diagnostico e o inicio do tratamento foi menor que 30 dias (34,39%). No segundo ano apos a pandemia, em 2021, a Paraiba registrou 450 novos casos de neoplasias hematologicas, sendo 280 no sexo masculino (62,22%). Neste ano, o tipo mais comum foram as leucemias (32,44%) seguido dos linfomas nao-Hodgkin (29,33%). A maioria dos diagnosticos se deu no estagio III (10,66%) e o tempo medio entre o diagnostico e o inicio do tratamento foi maior que dois meses na maioria dos casos, correspondendo a 42,88%. Discussao: A pandemia de COVID-19 trouxe diversas repercussoes para a area da saude, mais do que aquelas implicadas tao somente pela infeccao que o virus SARS-CoV-2 traz em si, porem nao afetou o numero dos diagnosticos de neoplasias hematologicas no estado da Paraiba. Cabe pontuar que aumentou o tempo entre o diagnostico e o inicio do tratamento, bem como houve mais diagnosticos em estagios mais avancados da doenca, talvez pela realocacao de recursos e infraestrutura redirecionados para atendimento das sindromes respiratorias agudas. Conclusao: Apesar de nao haver impactado no numero de diagnosticos, a pandemia de COVID-19 trouxe impactos prognosticos, com maior tempo ate inicio do tratamento e com diagnosticos em estagios mais avancados de doenca. Tambem cabe destacar a quantidade de dados computados nos campos dados como "Ignorado", "Nao aplica" ou "Outros", o que dificulta a analise fidedigna dos dados epidemiologicos. Copyright © 2022

Study of the sewage from a municipality in southern Minas Gerais, Brazil: correlation of physical and chemical variables, COVID-19 cases, and SARS-CoV-2 RNA concentration

Wastewater-based epidemiology is an important public health tool with great applicability when facing the COVID-19 pandemic, since infected individuals are able to excrete SARS-CoV-2 particles. In this context, this study aimed to correlate the number of cases of COVID-19 with physical and chemical variables and the presence of the virus in raw sewage samples from a sewage treatment plant (SIP) in the municipality of Lavras, Minas Gerais, Brazil, collected between the 19th and 25th epidemiological weeks. The samples were concentrated by electronegative membrane adsorption method and SARS-CoV-2 RNA was extracted, detected, and quantified by RT-qPCR using oligonucleotides and probes for the N gene. Moreover, the variables pH, total suspended solids, and chemical oxygen demand were evaluated. COVID-19 cases were obtained from epidemiological bulletins made available by the municipal government From the 24th epidemiological week on, a reduction in viral concentration (copies L-1) was observed concomitantly with the pandemic response countermeasures initiated by the municipality. A strong and significant positive correlation (p<0.05) between viral load and number of confirmed cases was obtained through Spearman's test. However, there was no correlation between the presence of the virus and the physical and chemical characteristics of the sewage. Therefore, it is suggested that further research be carried out in order to track SARS-CoV-2 concentrations in wastewater, thus corroborating with the fight against the pandemic and the achievement of epidemiological surveillance systems based on sewage monitoring.

[Pre-clinical validation of a turbine-based ventilator for invasive ventilation-The ACUTE-19 ventilator]. / Validación preclínica de un respirador de turbina para la ventilación invasiva: el respirador ACUTE-19.

Background: The severe acute respiratory syndrome-coronavirus 2 pandemic pressure on healthcare systems can exhaust ventilator resources, especially where resources are restricted. Our objective was a rapid preclinical evaluation of a newly developed turbine-based ventilator, named the ACUTE-19, for invasive ventilation. Methods: Validation consisted of (a) testing tidal volume delivery in 11 simulated models, with various resistances and compliances; (b) comparison with a commercial ventilator (VIVO-50) adapting the United Kingdom Medicines and Healthcare products Regulatory Agency-recommendations for rapidly manufactured ventilators; and (c) in vivo testing in a sheep before and after inducing acute respiratory distress syndrome by saline lavage. Results: Differences in tidal volume in the simulated models were marginally different (largest difference 33 ml [95% CI 31 to 36]; P < .001). Plateau pressure was not different (-0.3 cmH2O [95% CI -0.9 to 0.3]; P = .409), and positive end-expiratory pressure was marginally different (0.3 cmH2O [95% CI 0.2 to 0.3]; P < .001) between the ACUTE-19 and the commercial ventilator. Bland-Altman analyses showed good agreement (mean bias -0.29 [limits of agreement 0.82 to -1.42], and mean bias 0.56 [limits of agreement 1.94 to -0.81], at a plateau pressure of 15 and 30 cmH2O, respectively). The ACUTE-19 achieved optimal oxygenation and ventilation before and after acute respiratory distress syndrome induction. Conclusions: The ACUTE-19 performed accurately in simulated and animal models yielding a comparable performance with a VIVO-50 commercial device. The ACUTE-19 can provide the basis for the development of a future affordable commercial ventilator.

Validación preclínica de un respirador de turbina para la ventilación invasiva: el respirador ACUTE-19 Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator

Graphical Antecedentes La pandemia producida por el síndrome respiratorio agudo severo por coronavirus 2 puede agotar los recursos sanitarios, especialmente de respiradores, en situaciones de escasez de recursos sanitarios. Nuestro objetivo fue realizar una evaluación preclínica rápida de un prototipo de respirador de turbina para la ventilación invasiva denominado ACUTE-19. Métodos La validación consistió en: a) evaluación de la administración de un volumen corriente en 11 modelos pulmonares simulados, con diversas resistencias y compliancias;b) comparación con un ventilador comercial (VIVO-50) adaptando las recomendaciones de la Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido para ventiladores de fabricación rápida, y c) realización de pruebas in vivo en una oveja antes y después de inducir el síndrome de distrés respiratorio agudo mediante lavado salino. Resultados Las diferencias de volumen corriente en los modelos simulados fueron mínimamente diferentes (la mayor diferencia fue de 33 ml [IC 95%: 31 a 36];p < 0,001). La presión de meseta no fue diferente (−0,3 cmH2O [IC 95%: −0,9 a 0,3];p = 0,409), y la presión positiva al final de la espiración fue levemente diferente (0,3 cmH2O [IC 95%: 0,2 a 0,3];p < 0,001) comparando el ACUTE-19 y el ventilador comercial. El análisis de Bland-Altman mostró una buena concordancia (sesgo medio −0,29 [límites de concordancia 0,82 a −1,42], y sesgo medio 0,56 [límites de concordancia 1,94 a −0,81], a una presión de meseta de 15 y 30 cmH2O, respectivamente). El ACUTE-19 consiguió una oxigenación y ventilación óptimas antes y después de la inducción del síndrome de distrés respiratorio agudo en el modelo animal. Conclusiones El ACUTE-19 se comportó con precisión en los modelos simulados y animales, con un rendimiento comparable al del dispositivo comercial VIVO-50. El ACUTE-19 puede servir de base para el desarrollo de un futuro ventilador comercial asequible.

Pre-clinical validation of a turbine-based ventilator for invasive ventilation-The ACUTE-19 ventilator.

BACKGROUND: The Severe Acute Respiratory Syndrome (SARS)-Coronavirus 2 (CoV-2) pandemic pressure on healthcare systems can exhaust ventilator resources, especially where resources are restricted. Our objective was a rapid preclinical evaluation of a newly developed turbine-based ventilator, named the ACUTE-19, for invasive ventilation. METHODS: Validation consisted of (a) testing tidal volume (V_T) delivery in 11 simulated models, with various resistances and compliances; (b) comparison with a commercial ventilator (VIVO-50) adapting the United Kingdom Medicines and Healthcare products Regulatory Agency-recommendations for rapidly manufactured ventilators; and (c) in vivo testing in a sheep before and after inducing acute respiratory distress syndrome (ARDS) by saline lavage. RESULTS: Differences in V_T in the simulated models were marginally different (largest difference 33ml [95%-confidence interval (CI) 31-36]; P<.001ml). Plateau pressure (P_plat) was not different (-0.3cmH₂O [95%-CI -0.9 to 0.3]; P=.409), and positive end-expiratory pressure (PEEP) was marginally different (0.3 cmH₂O [95%-CI 0.2 to 0.3]; P<.001) between the ACUTE-19 and the commercial ventilator. Bland-Altman analyses showed good agreement (mean bias, -0.29, [limits of agreement, 0.82 to -1.42], and mean bias 0.56 [limits of agreement, 1.94 to -0.81], at a P_plat of 15 and 30cmH₂O, respectively). The ACUTE-19 achieved optimal oxygenation and ventilation before and after ARDS induction. CONCLUSIONS: The ACUTE-19 performed accurately in simulated and animal models yielding a comparable performance with a VIVO-50 commercial device. The acute 19 can provide the basis for the development of a future affordable commercial ventilator.

Exploring Content-Based and Meta-Data Analysis for Detecting Fake News Infodemic: A case study on COVID-19

The coronavirus pandemic (COVID-19) is probably the most disruptive global health disaster in recent history. It negatively impacted the whole world and virtually brought the global economy to a standstill. However, as the virus was spreading, infecting people and claiming thousands of lives so was the spread and propagation of fake news, misinformation and disinformation about the event. These included the spread of unconfirmed health advice and remedies on social media. In this paper, false information about the pandemic is identified using a content-based approach and metadata curated from messages posted to online social networks. A content-based approach combined with metadata as well as an initial feature analysis is used and then several supervised learning models are tested for identifying and predicting misleading posts. Our approach shows up to 93 % accuracy in the detection of fake news related posts about the COVID-19 pandemic. © 2022 IEEE.

Trans-continental analysis of over, 2000 Inflammatory Bowel Disease patients implicates geography, disease type, and exposure to immunosuppression as drivers of SARS-CoV-2 seroprevalence: data from the ICARUS-IBD Consortium

Background IBD patients on immune-modulatory therapies are considered high-risk for SARS-CoV-2 infection. Direct comparisons of serological responses to SARS-CoV-2 infection in IBD patients across different continents and medications are lacking. We performed SARS-CoV-2 sero-surveillance of IBD patients prior to vaccination at seven large tertiary centres in Asia, Europe, and North America. Methods Clinical data and sera were collected from, 2,213 IBD patients receiving routine care at institutions in Belgium, Canada, Hong Kong, India, Japan, the United Kingdom, and the United States between, 26 May, 2020 and, 24 September, 2021 (Table, 1). Sera were taken prior to vaccination. Clinical data were collected through patient questionnaires and medical records. Antibody reactivity to the SARS-CoV-2 spike protein was assessed using the Roche SARS-CoV-2 anti-spike total antibody and/or Siemens Healthineers COV2T anti-spike total antibody assays, which showed, 99.4% concordance. Univariate analysis was performed to evaluate association between individual variables and sero-status. Results The pre-vaccination seroprevalence of antibodies to SARS-CoV-2 in IBD patient varied widely according to location from, 0% in Hong Kong to, 57.9% in New Delhi, India (p<0.001). Rates in Europe and North America were similar (range, 3.57%-8.94%). Overall, SARS-CoV-2 seroprevalence appears to be equal to or less than local populations (Table, 2). Seroprevalence rates were associated with IBD type (7.8% CD, 12.4% UC, 15% IBD-U, p<0.001), smoking status (p<0.001), and history of COVID diagnosis (p<0.001) or COVID hospitalization (p=0.001), and any IMM (p<0.001). (Table, 3). Whilst there were no significant differences in seroprevalence between patients receiving infliximab (IFX), vedolizumab (VDZ), and ustekinumab (UST), antibody levels were attenuated in patients on IFX monotherapy and combination therapy (both p=0.002) and VDZ (p=0.02), compared with no medications (Figure 1). Conclusion We confirm in diverse poulations that exposure to biologics or immunomodulators, type of disease, and smoking status are associated with seroprevalence and antibody levels. We show for the first time the dominant influence of geographical location on sero-status in these patients. These observations should be considered as we look towards post-vaccination data to help stratify patients for clinical guidelines on SARS-CoV-2 vaccination.

TRANS-CONTINENTAL ANALYSIS OF OVER 2,000 INFLAMMATORY BOWEL DISEASE PATIENTS IMPLICATES GEOGRAPHY, DISEASE TYPE, AND EXPOSURE TO IMMUNOSUPPRESSION AS DRIVERS OF SARS-COV-2 SEROPREVALENCE

Background: IBD patients on immune-modulatory therapies are considered high-risk for SARS-CoV-2 infection. Direct comparisons of serological responses to SARS-CoV-2 infection in IBD patients across different continents and medications are lacking. We performed SARSCoV- 2 sero-surveillance of IBD patients prior to vaccination at seven large tertiary centres in Asia, Europe, and North America. Methods: Clinical data and sera were collected from 2,241 IBD patients receiving routine care at institutions in Belgium, Canada, Hong Kong, India, Japan, United Kingdom, and the United States between May 2020 and September 2021 (Table 1). Sera were taken prior to vaccination. Clinical data were collected from patient questionnaires and medical records. Antibody reactivity to the SARS-CoV-2 spike protein was assessed using the Roche SARS-CoV-2 anti-spike total antibody and/or Siemens Healthineers COV2T anti-spike total antibody assays, which showed 99.4% concordance. We performed univariate analysis to evaluate association between variables and sero-status. Results: The pre-vaccination seroprevalence of antibodies to SARS-CoV-2 in IBD patient varied widely according to location from 0% in Hong Kong, China, to 57.9% in New Delhi, India. Rates in Europe and North America were similar (range 3.6%-8.9%). Overall, SARSCoV- 2 seroprevalence appears to be equal to or less than local populations (Table 1). Seroprevalence rates were associated with IBD type (Crohn's disease 7.8%, ulcerative colitis 12.4%, IBD-unclassified 15.0%, p<0.001), smoking status (p<0.001), and history of COVID diagnosis (p<0.001) or COVID hospitalization (p=0.001), and any immunomodulator (IMM) (p<0.001) (Table 1). Infection as indicated by seropositivity in the absence of known COVID infection occurred in 7.3% of patients. Whilst there were no significant differences in seroprevalence between patients receiving anti-tumor necrosis factor (anti-TNF) medications, vedolizumab (VDZ), and ustekinumab (UST), antibody levels were attenuated in patients on anti-TNF monotherapy (p=0.002), anti-TNF + IMM combination therapy (p=0.002), and VDZ (p=0.02), compared with no medications (Figure 1). Conclusion: We confirm in diverse populations that exposure to anti-TNFs, vedolizumab and immunomodulators, type of disease, and smoking status are associated with seroprevalence and antibody levels. We show for the first time the dominant influence of geographical location on sero-status in these patients. These observations should be considered as we look towards post-vaccination data to help stratify patients for clinical guidelines on SARS-CoV-2 vaccination. (Table Presented) Table 1. Seroprevalence of total anti-SARS-CoV-2 spike antibodies in IBD patients by ICARUS centre with non-IBD controls noted for New Delhi, India, and publicly reported local seroprevalence and by selected patient characteristics.(Figure Presented) Figure 1. Antibody levels by medication group.

CONSCIENTIZAÇÃO PARA DOAÇÃO DE SANGUE E CADASTRO PARA DOAÇÃO DE MEDULA ÓSSEA EM PERÍODO DE INTERAÇÕES SOCIAIS LIMITADAS

Considerando a situação da pandemia de COVID-19 que diminuiu significativamente o número de pessoas aptas a doar sangue e que as doenças do sangue, câncer, cirurgias e traumas continuam, o Programa de Extensão “Amizade Compatível - uma doação para a vida” manteve initerruptamente o seu objetivo em conscientizar a comunidade da importância do cadastro e doação de sangue (DS) e de medula óssea (MO). Dessa maneira, o objetivo deste trabalho é apresentar ações extensionistas de conscientização para doação de sangue e de medula óssea realizadas em período de interações sociais limitadas. Materiais e métodos: Foram promovidos por alunos extensionistas, pela plataforma Google Meet, dezenove encontros com a participação de universitários, pacientes e seus familiares, profissionais de saúde, membros de associações, atiradores do Tiro de Guerra (TG) do município de Uberaba e comunidade em geral, durante 15 meses, com os temas: Indicações de hemocomponentes, Tipos Sanguíneos, Quem precisa de sangue, Abordagem de Redes Sociais para incentivo a DS, Campanhas Universitárias para captação de DS com curso de Medicina, Odontologia e Direito, Leucemia Pediátrica e uso de hemocomponentes, Conscientização para DS e para o cadastro de MO, Comemoração do Dia Nacional do Doador de MO, Comemoração do Dia Estadual da Anemia Falciforme, Comemoração do Dia Mundial da Luta contra o Câncer, Comemoração do Dia Nacional e Internacional da Talassemia além de relatos de pacientes com doença falciforme, talassemia, leucemia mieloide aguda, familiares de paciente com leucemia linfóide aguda e com doador de medula óssea. O programa também realizou na Universidade e no Hospital Universitário a Campanha intitulada Junho Vermelho para incentivar o espírito solidário das pessoas para doação de sangue. A divulgação de todas as ações foi realizada pelas redes sociais do Programa de Extensão, da Universidade e de forma particular pelos incentivadores e parceiros do programa de extensão. Resultados: O total de participantes dos dezenove encontros foi de 1636 pessoas. Momentos de relato de pacientes e seus familiares sobre a doença, sobre a dependência de transfusões e sobre a busca do doador de MO foram os que mais sensibilizaram os participantes. As postagens da Campanha do Junho Vermelho contaram com 2951 interações. Discussão: Ações extensionistas realizadas de forma online constituíram uma maneira segura de conscientizar a população da importância da realização da DS e o cadastro para doação de MO, de proporcionar o contato de alunos/comunidade com pacientes e profissionais de saúde, além de trazer à tona a dificuldade de os hemocentros manterem seus estoques de sangue principalmente em período de pandemia. Conclusão: A partir de diferentes plataformas online é possível contactar com facilidade diferentes públicos e realizar ações extensionistas de conscientização para DS e MO, colocando não só o universitário, potencial doador, em contato com os necessitam diretamente da transfusão sanguínea, mas também a comunidade em geral.

SÍNDROME DE RICHTER: LEUCEMIA LINFOCÍTICA CRÔNICA TRANSFORMADA EM LINFOMA DE HODGKIN CLÁSSICO, UM RELATO DE CASO

Leucemia Linfocítica Crônica (LLC) é a leucemia mais comum em adultos no mundo ocidental, possui comportamento indolente e baixa atividade mitótica, sendo seu diagnóstico feito geralmente em pacientes assintomáticos, com base em exame de sangue rotineiro, segundo a OMS. Já a sua transformação em linfoma agressivo – Síndrome de Richter Clássica (variante Linfoma Difuso de Grandes Células B) - é um evento raro e acontece em cerca de 2 a 8% dos casos e sua variante Linfoma de Hodgkin em menos de 1%. Neste trabalho, o objetivo foi descrever um caso de transformação desta leucemia em Síndrome de Richter variante Linfoma de Hodgkin. O paciente deste relato teve diagnóstico de leucemia linfocítica crônica, estadiado como BINET A. Apresentava IGHV não mutado, ausência de alterações no TP53 e positividade para vírus Epstein-Barr. Após 3 anos e 5 meses do diagnóstico de LLC recebeu quimioterapia convencional (fludarabina e ciclofosfamida) devido ao surgimento de sintomas constitucionais e linfonodomegalia cervical de 3 cm, com linfocitose associada (204.000 leucócitos, 94% linfócitos), sem anemia ou trombocitopenia. Apresentou resposta clínica e laboratorial. Depois de 1 ano do primeiro tratamento iniciou medicação alvo (Acalabrutinibe) pois teve aumento das linfonodomegalias cervicais. Evoluiu com resolução completa em um mês de tratamento. Passados 3 meses (4 anos e 10 meses do diagnóstico de LLC), houve o aparecimento de conglomerado linfonodal no mesmo local, associado a sintomas B. Uma nova biópsia revelou que o paciente enquadrava-se dentro dos 1% de pacientes que transformam LLC em Linfoma de Hodgkin. Seu subtipo foi o clássico, com celularidade mista, estadiado como Ann Arbor IVB, para o qual foi proposto quimioterapia com esquema ABVD (doxorrubicina, bleomicina, vinblastina, dacarbazina). Durante o tratamento apresentou mucosite e hematotoxicidade, recuperou-se e obteve resposta clínica após o primeiro ciclo. Após o segundo ciclo infectou-se por SARS-COV2, esteve internado com necessidade de ventilação mecânica e mesmo com atrasos no tratamento, em reavaliação com PET/CT, apresentou resposta satisfatória (Deauville 2). Atualmente está no terceiro ciclo de quimioterapia e em reabilitação após internamento prolongado que resultou em sequela motora por neuropatia do doente crítico. A terapia nesta situação não está embasada em estudos prospectivos randomizados e por conta disso conflui com o instituído para LH de novo. Este caso raro exemplifica como uma doença indolente pode se tornar agressiva, exigindo um cuidado específico nas reavaliações durante as recaídas de doença.