Author: "Beatriz Silva" / Publisher: elsevier - Searchworks@Jio Institute Digital Library Search Results

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1. Mycobacterium leprae and Mycobacterium lepromatosis in small mammals in Midwest Brazil

Author: Beatriz Silva Nogueira, Maerle Oliveira Maia, Ravena Fernanda Braga de Mendonça, Luciano Nakazato, and Valéria Dutra
Subjects: RLEP, RLPM, Amazonia, Cerrado, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract: Leprosy is a chronic infectious disease caused by the bacilli Mycobacterium leprae and Mycobacterium lepromatosis. In addition to humans, animals such as nine-banded armadillos and red squirrels are species naturally infected. The objective of this study was to investigate the presence of M. leprae and M. lepromatosis in non-volant small mammals of the order Didelphimorphia and Rodentia through Polymerase Chain Reaction (PCR) assay. During 2015 and 2018, field expeditions were carried out in three municipalities, covering biotic elements of the Amazon and Cerrado biomes, in the Mato Grosso State, Midwest of Brazil. A specific primer for repetitive sequences of the genomic DNA of M. leprae and M. lepromatosis targeting the RLEP and RLPM gene, respectively, was used to screen for these agents. The molecular detection of M. leprae DNA in the samples was 13.8%. M. lepromatosis was not detected. The present study reports a description of M. leprae in small non-volant mammals in Brazil.
Published: 2024
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2. Acute toxicity of trypsin inhibitor from tamarind seeds in embryo and adult zebrafish (Danio rerio)

Author: Yohanna Layssa dos Santos Melo, Ana Carolina Luchiari, Beatriz Silva Lopes, Maria Gabriela Ferreira Rocha Silva, Tatiana dos Santos Pais, João Eduardo Procópio Gama Cortez, Christina da Silva Camillo, Sérgio Adriane Bezerra de Moura, Juliana Kelly da Silva-Maia, and Ana Heloneida de Araújo Morais
Subjects: Tamarindus indica L., Preclinical model, Embryotoxicity, Cardiotoxicity, Neurotoxicity, Genotoxicity, Toxicology. Poisons, RA1190-1270
Abstract: The trypsin inhibitor isolated from tamarind seeds (TTI) is being investigated for potential applications in the treatment of noncommunicable diseases (NCD), such as hypertension, obesity, and diabetes. This study aimed to assess TTI embryotoxicity and acute toxicity in adult zebrafish (Danio rerio). TTI was extracted and isolated from tamarind seeds. Embryonic and adult zebrafish were exposed for 96 hours to three concentrations of TTI (12.5, 25, and 50 mg/L). Zebrafish embryos (n=60 per group) were evaluated for survival, hatching, malformations, and potential developmental marker alterations, in addition to cardiotoxicity and neurotoxicity tests. For acute toxicity assessment in adults (n=20 per group), survival and locomotor and anxiety-like behaviors were assessed, along with genotoxicity (micronucleus) evaluation. Embryos exposed to TTI showed no significant adverse effects, presented normal heart rates and positive reflex response in the neurotoxicity tests. In adult fish, TTI did not cause mortality or significant behavioral changes, suggesting no neurotoxicity and no genotoxicity. Histopathological analyses of the whole body showed only changes in the liver and spinal cord, similar to those observed in the control group not exposed to TTI. These findings indicate TTI's biosafety and therapeutic potential in complex organisms. Further research is required to evaluate its long-term effects and efficacy in treating non-communicable diseases.
Published: 2024
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3. PERFIL EPIDEMIOLÓGICO DE HANTAVIROSE ENTRE 2012 E 2022, NO BRASIL

Author: Beatriz Silva de Marco, Alice Sarno Menezes, Gabriela Loula Dourado do Nascimento, Gabriel von Flach Sarmento, Davi Domingos dos Santos Ferreira, Guilherme von Flach Sarmento, Victor De Oliveira Alvim Albergaria, and Plácido Natanael de Lima Neto
Subjects: Brasil Hantavirose Perfil epidemiológico, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract: Introdução: A hantavirose é uma doença viral aguda, e pode ser transmitida a partir da inalação de aerossóis de excretas de roedores e, raramente, por sua mordida. Pode causar síndromes clínicas como: Síndrome Cardiopulmonar por Hantavirose ou Febre Hemorrágica com Síndrome Renal (FHSR). O FHSR pode se manifestar de diferentes formas, podendo ser assintomática, ou com apresentação súbita de febre, cefaleia, lombalgia e dor abdominal, podendo evoluir para um quadro de choque, hemorragia e insuficiência renal. Esse tipo de Febre Hemorrágica tem taxa de mortalidade entre 6 e 15%, e com necessidade de notificação compulsória. Assim, por conta de seu quadro clínico possivelmente fatal, faz-se necessário compreender o perfil epidemiológico da condição. Objetivo: Traçar o perfil epidemiológico dos casos de hantavirose no Brasil no período de 2012 a 2022. Metodologia: Trata-se de um estudo quantitativo, ecológico, descritivo, baseado em dados notificados no Sistema de Informações de Agravos de Notificação (SINAN/SUS) do Ministério da Saúde por meio do DATASUS, entre Jan/2012 e Dez/2022. Foram analisadas as seguintes variáveis: raça, faixa etária, sexo e região. Resultados: No período analisado, houve 788 casos de hantavirose. Quanto ao sexo biológico, 76,52% dos casos registrados foram do sexo masculino e 23,48% do sexo feminino. Em relação à raça/cor, a maioria dos casos, 63,20%, ocorreram em pessoas brancas. Os indivíduos pardos ocuparam o segundo lugar, com 26,40%. Já os pretos, amarelos e indígenas representam 6,09% dos casos. Não se obteve informações da raça/cor em 4,31% dos casos. Tratando-se de faixa etária, a população de 20 a 39 anos foi a mais acometida, representando 48,48% dos casos. Ademais, a faixa etária entre 40 e 59 anos representou 34,14% dos casos, enquanto crianças e adolescentes representam 11,42% e idosos, 5,96%. Ao analisar as regiões, a região Sul possui o maior número de casos, 43,78%, seguida pelo Centro-Oeste e Sudeste, com 26,52% e 25,13%, respectivamente. Conclusão: Portanto, ao analisar os resultados obtidos nos últimos 10 anos, o perfil epidemiológico mais atingido é formado por indivíduos do sexo masculino, brancos, entre 20 e 39 anos e da região Sul. Assim, tendo em vista que a análise dos casos de hantavirose pode ajudar a entender os obstáculos e auxiliar na prevenção para reduzir casos futuros, faz-se fundamental que o poder público fique atento a esse perfil epidemiológico, objetivando a prevenção e controle de tal moléstia.
Published: 2023
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4. PERFIL EPIDEMIOLÓGICO DA TUBERCULOSE GENITURINÁRIO NO BRASIL, ENTRE 2004 E 2023

Author: Gabriel von Flach Sarmento, Guilherme von Flach Sarmento, Plácido Natanael de Lima Neto, Beatriz Silva de Marco, Victor de Oliveira Alvim Albergaria, Alice Sarno Menezes, Gabriela Loula Dourado do Nascimento, and Davi Domingos dos Santos Ferreira
Subjects: Brasil Perfil epidemiológico Trato geniturinário Tuberculose, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract: Introdução: A Tuberculose (TB) é uma patologia granulomatosa crônica, apresentando como principal agente etiológico o Mycobacterium tuberculosis. Ela é considerada como a principal doença infecciosa causadora de óbitos em todo o globo. Apesar de seu principal sítio de infecção ser o pulmão, o trato geniturinário (TGU) pode ser acometido pela infecção. Por conta de sua importância, faz-se necessário compreender as características dos pacientes que são acometidos pela patologia. Objetivos: Analisar as internações por TB do TGU, além de caracterizar o perfil epidemiológico dos afetados, no Brasil, entre 2004 e 2023. Metodologia: Um estudo descritivo, ecológico e quantitativo com dados do departamento de informática do SUS (DATASUS). As informações obtidas foram referentes às internações por TB do TGU, entre Jan/2004 e Mar/2023, no Brasil, a partir do Sistema de Informação de Agravos de Notificação (SINAN). Resultados: Houve um total de 6373 internações, onde o ano com maior e menor número foram 2004 (517) e 2023 (58), respectivamente. A região mais afetada foi a Sudeste (3515; 55,2%), seguida pelo Sul (1119; 17,6%) e Nordeste (1077; 16,9%). Destas, os principais representantes foram São Paulo (SP) (1922; 30,2%), Rio Grande do Sul (603; 9,5%) e Bahia (365; 5,7%). As faixas etárias mais acometidas foram entre 40 e 49 (1419; 22,27%), 30 e 39 (1297; 20,35%) e 50 e 59 anos (1249; 19,6%). Já o sexo, 3571 (56,03%) eram do sexo masculino, enquanto 2800 (43,94%) pacientes eram do feminino. Ademais, 229 (4%) eram tabagistas, 310 (5%) etilistas e 105 (2%) usuários de drogas ilícitas. Apesar disto, uma fração importante dos pacientes não preencheu os hábitos aqui apresentados (59%; 25%; e 59%, respectivamente). Conclusão: A partir dos dados aqui apresentados, fica explícito que as internações por TB do TGU apresentaram uma leve queda, com uma estabilização a partir do ano de 2011. Nota-se um maior acometimento pelo Sudeste, com destaque para SP, por paciente do sexo masculino, com faixa etária de 30 a 59 anos. Além disso, percebeu-se que a maior parte dos pacientes não apresentavam hábitos que pudessem piorar sua condição de base. Por fim, entretanto, observou-se que uma fração considerável dos pacientes não tinham a ficha preenchida de maneira adequada. Isto torna-se um desafio importante para o traçado adequado e preciso do perfil epidemiológico dos pacientes, bem como seus hábitos, o que traria informações preciosas para possíveis medidas de prevenção da condição.
Published: 2023
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5. Development of deep learning segmentation models for coronary X-ray angiography: Quality assessment by a new global segmentation score and comparison with human performance

Author: Miguel Nobre Menezes, João Lourenço-Silva, Beatriz Silva, Oliveira Rodrigues, Ana Rita G. Francisco, Pedro Carrilho Ferreira, Arlindo L. Oliveira, and Fausto J. Pinto
Subjects: Aprendizagem profunda, Inteligência artifical, Aprendizagem de máquinas, Coronariografia, Doença coronária, Intervenção coronária percutânea, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Introduction and objectives: Although automatic artificial intelligence (AI) coronary angiography (CAG) segmentation is arguably the first step toward future clinical application, it is underexplored. We aimed to (1) develop AI models for CAG segmentation and (2) assess the results using similarity scores and a set of criteria defined by expert physicians. Methods: Patients undergoing CAG were randomly selected in a retrospective study at a single center. Per incidence, an ideal frame was segmented, forming a baseline human dataset (BH), used for training a baseline AI model (BAI). Enhanced human segmentation (EH) was created by combining the best of both. An enhanced AI model (EAI) was trained using the EH. Results were assessed by experts using 11 weighted criteria, combined into a Global Segmentation Score (GSS: 0–100 points). Generalized Dice Score (GDS) and Dice Similarity Coefficient (DSC) were also used for AI models assessment. Results: 1664 processed images were generated. GSS for BH, EH, BAI and EAI were 96.9+/-5.7; 98.9+/-3.1; 86.1+/-10.1 and 90+/-7.6, respectively (95% confidence interval, p
Published: 2022
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6. Clinical experience of a cardio-oncology consultation at a tertiary university hospital in Portugal: An observational study

Author: Manuela Fiuza, Andreia Magalhães, Miguel Nobre Menezes, Paula Costa, Leonor Abreu Ribeiro, Catarina Abreu, Raquel Brás, Joana Vieira, Ana I. Duarte, Pedro Morais, Beatriz Silva, Luís Costa, and Fausto J. Pinto
Subjects: Consulta de cardio-oncologia, Fatores de risco cardiovasculares, Cardiotoxicidade, FEVE, Desfecho, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Introduction: Heart disease and cancer are the two leading causes of morbidity and mortality worldwide. Advances in cancer screening and management have led to longer survival and better quality of life. Despite this progress, many cancer patients experience cardiovascular complications during and after cancer treatment. This study describes the experience of a cardio-oncology program at tertiary academic hospital. Methods: In this retrospective observational study, cancer patients referred to the CHULN cardio-oncology consultation (COC) between January 2016 and December of 2019 were included. Data collected included: patient demographics, cancer type, reason for referral, cardiovascular risk factors, cardiac and oncologic treatments and clinical outcomes. Results: A total of 520 patients (mean age: 65 ± 14 years; 65% women) were referred to the COC. The main reasons for referral were suspected heart failure (26%), pre-high risk chemotherapy assessment (20%) and decreased LVEF (15%). Pre-existing cardiovascular risk factors were common (79%) and 309 (59%) were taking cardiac medications. The most common type of malignancy was breast cancer (216, 41%) followed by gastrointestinal (139, 27%). More than half received anthracycline-based regimens (303, 58%). Most patients (401; 77%) successfully completed cancer therapy. At the time of last data collection, the majority of patients were alive (430, 83%). Cardiac-related mortality was observed in 16%. Conclusions: The close collaboration between cardiology and oncology teams and timely cardiac monitoring was the key to the majority of patients to completing their prescribed cancer therapy. Resumo: Introdução: As doenças cardiovasculares e o cancro são as principais causas de morbilidade e mortalidade em todo o mundo. Avanços na triagem e tratamento do cancro têm permitido uma sobrevivência mais longa e uma melhor qualidade de vida. Apesar deste progresso, muitos pacientes com cancro apresentam complicações cardiovasculares durante e após o tratamento oncológico. Este estudo descreve a experiência de um programa de cardio-oncologia num hospital universitário terciário. Métodos: Neste estudo observacional retrospetivo, foram incluídos pacientes com cancro referenciados para consulta de cardio-oncologia (CCO) do CHULN entre janeiro de 2016 e dezembro de 2019. Os dados coletados foram: dados demográficos, tipo de cancro, motivo de referenciação, fatores de risco cardiovasculares (FRCV), terapêutica cardíaca e oncológica e desfechos clínicos. Resultados: Foram referenciados para a CCO, 520 pacientes (idade média: 65 ± 14 anos; 65% mulheres). Os principais motivos de referenciação foram: suspeita de insuficiência cardíaca (26%), avaliação pré-quimioterapia de alto risco (20%) e diminuição da FEVE (15%). CVRF pré-existentes foram frequentes (79%) e 309 (59%) estavam com terapêutica cardiovascular. O tipo de cancro mais frequente foi o cancro da mama (216; 41%), seguido pelo cancro gastrointestinal (139; 27%). Mais da metade dos pacientes tez terapêutica oncológica baseada em antraciclinas (303, 58%). A maioria dos pacientes (401; 77%) completou com sucesso a terapêutica oncológica. Na altura da última coleta de dados a maioria dos pacientes estava viva (430, 83%). A mortalidade relacionada com o coração foi observada em 16%. Conclusões: A estreita colaboração entre as equipas de cardiologia e oncologia e a monitorização cardíaca atempada foi decisiva para que a maioria dos pacientes concluísse o tratamento oncológico.
Published: 2022
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7. Toxicology and Biodistribution: The Clinical Value of Animal Biodistribution Studies

Author: Beatriz Silva Lima and Mafalda Ascensão Videira
Subjects: gene therapy, risk-based approach, preclinical programs, biodistribution, model relevance, advanced therapy medicinal products, ATMPs, Genetics, QH426-470, Cytology, QH573-671
Abstract: Since the human genome decoding, understanding and identification of genetic disturbances behind many diseases, including cancer, are intensively increasing. Scientific and technological advances in this area trigger the search for therapeutic (curative) approaches targeting the correction of gene disturbances. Gene therapy medicinal products (GTMPs) emerge in this context, bringing new challenges for their characterization. Compared to small molecules, biodistribution is fundamental to identifying target organs and anticipating safety and efficacy, may be integrated into safety and pharmacology studies, and may eventually be anticipated based on specificities of vectors and constructs. This review describes and discusses the requirements for nonclinical development and evaluation of GTMPs versus conventional ones and the needs and challenges of constructing nonclinical packages that assure GTMPs’ human safety from early development, taking into consideration usefulness and/or limitations of many conventional, preclinical models. The experience gained in the European context is referenced.
Published: 2018
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8. Contributors

Author: Barrow, Paul, primary, Bayne, Kathryn, additional, Bluemel, Joerg, additional, Brennan, Frank, additional, Bolton, Iris D., additional, Bowman, Christopher J., additional, Buck, Wayne R., additional, Burns-Naas, Leigh Ann, additional, Burr, David B., additional, Cann, Jennifer A., additional, Cauvin, Annick J., additional, Cavagnaro, Joy A., additional, Certa, Ulrich, additional, Chapman, Kathryn, additional, Chellman, Gary J., additional, Coogan, Timothy P., additional, Couch, Jessica, additional, de Haan, Lolke, additional, Decelle, Thierry, additional, Delaunois, Annie, additional, Faggioni, Raffaella, additional, Ferguson, Betsy, additional, Finch, John, additional, Fisher, Virginia, additional, Frings, Werner, additional, Gelzleichter, Thomas, additional, Gschwind, Andreas, additional, Hall, Robert, additional, Halpern, Wendy G., additional, Heckel, Tobias, additional, Henson, Kristin L., additional, Henwood, Susan, additional, Heyen, Jonathan R., additional, Iverson, William Oliver, additional, Kallman, Mary Jeanne, additional, Kaspareit, Joachim, additional, Koban, Tina, additional, Korte, Sven, additional, Lainée, Pierre, additional, Leach, Michael W., additional, LeSauteur, Lynne, additional, Lewis, Anne D., additional, Lima, Beatriz Silva, additional, Ma, Yanfei L., additional, Mansfield, Keith G., additional, Luetjens, C. Marc, additional, Martin, Pauline L., additional, Mätz-Rensing, Kerstin, additional, Mikkelsen, Lars Fris, additional, Mounho-Zamora, Barbara, additional, Müller, Wolfgang, additional, Murphy, Dennis J., additional, Niehoff, Marc, additional, Niggemann, Birgit, additional, Palmer, Helen, additional, Patrick, Daniel J., additional, Peters, Christopher, additional, Piché, Marie-Soleil, additional, Prescott, Mark, additional, Prongay, Kamm, additional, Rebelatto, Marlon C., additional, Reymond, Alexandre, additional, Richman, Laura, additional, Roos, Christian, additional, Roskos, Lorin K., additional, Saravanan, Chandrassegar, additional, Sasseville, Vito G., additional, Schenck, Emanuel, additional, Schmitt, Georg, additional, Shenton, Jacintha M., additional, Singh, Anjali, additional, Skinner, Matthew, additional, Smith, David Glenn, additional, Stephan-Gueldner, Markus, additional, Todd, Marque, additional, Tseng, Chih-Ming L., additional, Vahle, John L., additional, Valentin, Jean-Pierre, additional, Vargas, Hugo M., additional, Wakshull, Eric, additional, Walter, Lutz, additional, Weinbauer, Gerhard F., additional, Wistuba, Joachim, additional, Yang, Harry, additional, and Zinner, Dietmar, additional
Published: 2015
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9. Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals

Author: Cavagnaro, Joy A., primary and Lima, Beatriz Silva, additional
Published: 2015
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10. Contributors

Author: Brian N. Legarth, Luis M. Alves, Maria Beatriz Silva, and Niels Bay
Published: 2021

11. Effect of thermo-mechanical cycling and chlorhexidine on the bond strength of universal adhesive system to dentin

Author: Ana Beatriz Silva Sousa, Rocio Geng Vivanco, Rafaella Tonani-Torrieri, Renata Silva Cardoso, Michelle Alexandra Chinelatti, Sergio Augusto de Freitas Vincenti, and Fernanda de Carvalho Panzeri Pires-de-Souza
Subjects: 0301 basic medicine, Molar, Materials science, CLOREXIDINA, Temperature cycling, Material science, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, stomatognathic system, medicine, Dentin, lcsh:Social sciences (General), Thermo-mechanical cycling, lcsh:Science (General), Phosphoric acid, Bond strength, Dentin bonding durability, Multidisciplinary, Chlorhexidine, Universal adhesive systems, 030104 developmental biology, medicine.anatomical_structure, Distilled water, chemistry, lcsh:H1-99, Adhesive, 030217 neurology & neurosurgery, Nuclear chemistry, medicine.drug, lcsh:Q1-390
Abstract: Objectives This study evaluated the influence of thermo-mechanical cycling (TMC) on the bond strength (BS) of a universal adhesive system (UAS - Adper Single Bond Universal, 3M ESPE) to dentin treated or not with 0.2% chlorhexidine (CHX). Methods Eighty human molars were flattened until reach the dentin and separated into 4 groups according to the bonding protocol: ENR Group: 37% phosphoric acid + 3-step etch-and-rinse adhesive system (ENR); UAS Group: UAS in self-etch mode; ENR + CHX Group: 37% phosphoric acid + CHX + ENR; UAS + CHX Group: CHX + UAS in self-etch mode. After treatments, teeth were restored (Filtek Z350, 3M ESPE). Samples (n = 10) were submitted to aging process: stored in distilled water at 37°C/30 days or TMC (ERIOS - 98N/1.6Hz + thermal cycling 5/37/55 °C - 1,200,000 cycles). Specimens were sectioned into sticks (1.0 mm2) and submitted to the microtensile test (Mechanical Test Machine - 0.5 mm/min). Fracture patterns and hybrid layer integrity were analyzed under Stereomicroscope and Scanning Electron Microscopy (SEM). Results The BS results (3-way ANOVA, Bonferroni's test, α = 5%) showed that groups treated with CHX presented higher BS values than control groups; significant in all cases (p < .05), except for ENR submitted to TMC (p > .05). When CHX was applied and samples were cycled, UAS revealed higher BS (p < .05) than ENR. After TMC, cohesive fractures increased for UAS, regardless of CHX application. SEM analysis demonstrated different hybridization patterns for the adhesive systems tested. Conclusion The performance of the universal adhesive system used in self-etch mode was better than that of the 3-step etch-and-rinse adhesive system. Clinical significance Universal adhesive systems have been developed in order to simplify the dentin hybridization protocol. It is important to determine the longevity of the adhesive interface using these bonding materials after chewing., Material science, Thermo-mechanical cycling; Bond strength; Chlorhexidine; Universal adhesive systems; Dentin bonding durability.
Published: 2020

12. Formability limits in sheet-bulk forming

Author: Maria Beatriz Silva, Ivo M. F. Bragança, J.P. Magrinho, Carlos M.A. Silva, P.N.C. Leonardo, and Paulo A.F. Martins
Subjects: Shearing (physics), 0209 industrial biotechnology, Digital image correlation, Finite element method, Materials science, Ductile damage, Mechanical Engineering, Sheet lengthwise compression, Forming processes, 02 engineering and technology, Fracture forming limits, Industrial and Manufacturing Engineering, Physics::Geophysics, 020303 mechanical engineering & transports, 020901 industrial engineering & automation, 0203 mechanical engineering, Sheet-bulk forming, Formability, Deformation (engineering), Composite material, Anisotropy, Experimentation, Plane stress
Abstract: This paper is focused on the characterization of the fracture limits in sheet-bulk forming. The approach extends to crack opening in mode III (out-of-plane shearing), a digital image correlation-based methodology for determining the fracture forming limits in mode I (tension) and mode II (in-plane shearing). For this purpose, a sheet lengthwise compression test with different end constraints is developed and utilized to obtain the strain loading paths up to fracture in mode III, for the first time directly from sheets. The three fracture forming limits of sheet-bulk forming are first characterized in principal strain space and then transformed into the space of effective strain vs. stress triaxiality by means of an analytical procedure based on anisotropic plastic deformation under proportional loading. A new uncoupled ductile damage criterion is introduced and successfully implemented in an in-house finite element computer program to predict the location where the out-of-plane shearing cracks are triggered. The overall results point out to the difficulty in merging the three different fracture forming limits into a single-branched fracture locus covering the plane stress deformation conditions and the three-dimensional states of stress that are likely to be found in sheet-bulk forming processes.
Published: 2020

13. On the manufacturing of highly-customized near net-shape medical implants using magnesium alloy sheet

Author: Universidad de Sevilla. Departamento de Ingeniería Mecánica y de Fabricación, Universidad de Sevilla. TEP -111 Ingeniería Mecánica, Agencia Catalana para Gestión de Ayudas Universitarias y de Investigación 2017-SGR- 0385, Castells, Joan, Guiglielmi, Pasquale, Ferrer, Inés, Centeno Báez, Gabriel, Palumbo, Gianfranco, Beatriz Silva, M., García Romeu, María Luisa, Universidad de Sevilla. Departamento de Ingeniería Mecánica y de Fabricación, Universidad de Sevilla. TEP -111 Ingeniería Mecánica, Agencia Catalana para Gestión de Ayudas Universitarias y de Investigación 2017-SGR- 0385, Castells, Joan, Guiglielmi, Pasquale, Ferrer, Inés, Centeno Báez, Gabriel, Palumbo, Gianfranco, Beatriz Silva, M., and García Romeu, María Luisa
Abstract: The purpose of this work is defining a global methodology framework for the manufacturing of medical implants using Mg alloys by Incremental Forming process from the results attained by the authors in this field. The methodology proposed considers two main steps, an indispensable related to material characterization that includes from the classical and mechanical to spifability testing and it includes numerical simulations. And another one related mainly to implant forming taking into account the best process parameters from the analysis carried out in the previous step. As newness, two variants of the incremental forming process, Single (SPIF) and Two-Point (TPIF) Incremental Forming, are used for the same magnesium implant geometry. Different outputs variables, mainly: Ra, Shape accuracy and Thicknesses, besides Force and Temperature were analysed for comparison purposes.
Published: 2020

14. Hole-flanging by single point incremental forming

Author: Maria Beatriz Silva, Niels Bay, and Paulo A.F. Martins
Subjects: Engineering drawing, Materials science, Fabrication, Flanging, Process (computing), Formability, Single point, Blank
Abstract: This chapter presents new developments in the fabrication of hole-flanges by single point incremental forming (SPIF) that comply with today’s requirements of flexible manufacturing under economically viable small-batch sizes. The content is aimed at providing readers a broad understanding of the deformation mechanics of hole-flanging produced by SPIF in order to allow them to: (i) understand plastic flow and failure resulting from the interaction between the forming tool and the sheet blank in different types of hole-flanges and (ii) identify the major process parameters and to recognize the influence of the precut geometry in the formability limits of the process.
Published: 2016

15. Flexible roll forming

Author: H. Moslemi Naeini, Maria Beatriz Silva, Paulo A.F. Martins, M. M. Kasaei, and Behnam Abbaszadeh
Subjects: Physics, business.industry, Forming processes, Structural engineering, Flange, Finite element method, Material flow, Stress (mechanics), Cross section (physics), visual_art, visual_art.visual_art_medium, Roll forming, Sheet metal, business
Abstract: Roll forming is one of the most common sheet metal forming processes to produce continuously a large variety of profiles with constant cross section in the longitudinal direction at high production rates. Flexible roll forming (FRF) is a new advanced variant of the roll forming process that has been developed to produce variable cross section profiles that are commonly used in the automotive, railway, ship construction, and building industries. As with all new forming processes, the deformation mechanics of FRF is still not fully understood and, therefore, the aim of this chapter is to investigate material flow and failure by wrinkling by combining experimental results with numerical predictions derived from finite element analysis. The presentation allows readers to understand the physics behind the distribution and evolution of stresses and strains with time and also to realize how the combined influence of effective strain and stress triaxiality can be used to investigate the occurrence of flange wrinkling in variable cross section profiles produced by FRF.
Published: 2015

16. Recent Approaches for the Determination of Forming Limits by Necking and Fracture in Sheet Metal Forming

Author: Carpóforo Vallellano, A.J. Martínez-Donaire, Maria Beatriz Silva, D. Morales-Palma, Paulo A.F. Martins, Gabriel Centeno, Universidad de Sevilla. Departamento de Ingeniería Mecánica y de Fabricación, Universidad de Sevilla. TEP111: Ingeniería Mecánica, and Ministerio de Economía y Competitividad (MINECO). España
Subjects: Materials science, Tension (physics), fungi, Failure, Forming processes, General Medicine, Sheet metal forming, Necking, Instability, Shear (sheet metal), Fracture, visual_art, visual_art.visual_art_medium, Fracture (geology), Composite material, Sheet metal, Engineering(all)
Abstract: Forming limit diagrams (FLD’s) are used to evaluate the workability of metal sheets. FLD’s provide the failure locus at which plastic instability occurs and localized necking develops (commonly designated as the forming limit curve - FLC), and the failure loci at the onset of fracture by tension (FFL) or by in-plane shear (SFFL). The interest of metal formers in controlling localized necking is understandable because the consequence of plastic instability is an undesirable surface blemish in components. However, because under certain loading conditions fracture can precede necking in sheet metal forming processes, there is a growing interest in characterizing the forming limits by necking and fracture in the FLD’s. This paper gathers together a number of recently developed methodologies for detecting the onset of local necking and fracture by in-plane tension or in-plane shear, and discusses their applicability to determine experimentally the FLC’s, FFL’s and SFFL’s. Ministerio de Economía y Competitividad DPI2012-32913
Published: 2015

17. Contributors

Author: Paul Barrow, Kathryn Bayne, Joerg Bluemel, Frank Brennan, Iris D. Bolton, Christopher J. Bowman, Wayne R. Buck, Leigh Ann Burns-Naas, David B. Burr, Jennifer A. Cann, Annick J. Cauvin, Joy A. Cavagnaro, Ulrich Certa, Kathryn Chapman, Gary J. Chellman, Timothy P. Coogan, Jessica Couch, Lolke de Haan, Thierry Decelle, Annie Delaunois, Raffaella Faggioni, Betsy Ferguson, John Finch, Virginia Fisher, Werner Frings, Thomas Gelzleichter, Andreas Gschwind, Robert Hall, Wendy G. Halpern, Tobias Heckel, Kristin L. Henson, Susan Henwood, Jonathan R. Heyen, William Oliver Iverson, Mary Jeanne Kallman, Joachim Kaspareit, Tina Koban, Sven Korte, Pierre Lainée, Michael W. Leach, Lynne LeSauteur, Anne D. Lewis, Beatriz Silva Lima, Yanfei L. Ma, Keith G. Mansfield, C. Marc Luetjens, Pauline L. Martin, Kerstin Mätz-Rensing, Lars Fris Mikkelsen, Barbara Mounho-Zamora, Wolfgang Müller, Dennis J. Murphy, Marc Niehoff, Birgit Niggemann, Helen Palmer, Daniel J. Patrick, Christopher Peters, Marie-Soleil Piché, Mark Prescott, Kamm Prongay, Marlon C. Rebelatto, Alexandre Reymond, Laura Richman, Christian Roos, Lorin K. Roskos, Chandrassegar Saravanan, Vito G. Sasseville, Emanuel Schenck, Georg Schmitt, Jacintha M. Shenton, Anjali Singh, Matthew Skinner, David Glenn Smith, Markus Stephan-Gueldner, Marque Todd, Chih-Ming L. Tseng, John L. Vahle, Jean-Pierre Valentin, Hugo M. Vargas, Eric Wakshull, Lutz Walter, Gerhard F. Weinbauer, Joachim Wistuba, Harry Yang, and Dietmar Zinner
Published: 2015

18. Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals

Author: Joy A. Cavagnaro and Beatriz Silva Lima
Subjects: Clinical trial, Alternative methods, Biopharmaceutical, Risk analysis (engineering), Species selection, business.industry, Medicine, Product (category theory), Guideline, Pharmacology, business, Animal species, Nonhuman primate
Abstract: Preclinical safety evaluation aims to support clinical trial initiation and subsequent progress through studies according to guidelines provided by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (International Conference on Harmonisation, ICH). For biopharmaceuticals, the ICH S6 guideline (1996) was unique in primarily recommending a basic framework for preclinical safety evaluation rather than prescribing study design set(s). Although preceding establishment of the “3Rs” (replace, reduce, refine), the guidance was consistent with those principles. Despite stressing the importance of selecting relevant animal species for toxicity assessment, it omitted the term most relevant to avoid nonhuman primate (NHP) species as the systematic first choice. Over the years, accumulated knowledge of specific products, product classes, and across various product classes led to improved preclinical developments, but NHP use increased rather than decreased, in large part to be more consistent with the practices used for pharmaceuticals (ICH M3). Therefore, the addendum (ICH S6 (R1), 2012) reinforced the importance of an alternative approach based on product attributes explicitly addressing the “3R” principles, and it expanded topics especially relevant to NHP use (species selection, study design, immunogenicity, reproductive toxicity). In vitro alternative methods for safety evaluation are also referred and encouraged. This chapter addresses the use and usefulness of NHP research, particularly for biopharmaceutical safety assessment, and discusses its future effect by emerging scientific and technological advances, including in vitro, human-based systems.
Published: 2015

19. Novel experimental techniques for the determination of the forming limits at necking and fracture

Author: Paulo A.F. Martins, Carpóforo Vallellano, Maria Beatriz Silva, A.J. Martínez-Donaire, D. Morales-Palma, and Gabriel Centeno
Subjects: Materials science, Experimental testing, Forming limit diagram, visual_art, visual_art.visual_art_medium, Formability, Forming processes, Fracture mechanics, Composite material, Sheet metal, Anisotropic plasticity, Necking
Abstract: Forming limit diagrams (FLDs) are currently the most useful and used tool for evaluating the workability of metal sheets. FLDs provide the failure locus at the onset of necking (commonly designated as the forming limit curve [FLC]) and at the onset of fracture in the principal strain space. The FLC is usually determined by means of Nakazima and Marciniak tests following the ISO 12004-2:2008 standard but the procedure for evaluating the necking strains presents difficulties that often lead to the fact that FLCs of the same material provided by different sources present sensible differences from each other. The interest in the determination of the onset of fracture has always been limited because most of the conventional sheet metal forming processes reach their formability limits at the onset of necking. However, this trend is progressively changing as a result of the growing interest and rapid development of new increment sheet forming processes in which plastic deformation is successfully accomplished for strain loading paths well above the FLC. On the other hand, a recently developed analytical framework built upon the fundamental concepts of anisotropic plasticity, ductile damage, and fracture mechanics helps better understanding of the relation between formability limits by fracture and crack opening modes. Both fracture limits by tension (also known as the fracture forming limit line [FFL]) and by in-plane shear (also known as the shear fracture forming limit line [SFFL]) will be characterized and experimentally determined. This chapter focuses on the innovative methods and procedures that were recently developed by the authors for the determination of the formability limits by necking (FLC) and fracture (FFL/SFFL), and on the application of FLDs to stretch-bending and single-point incremental forming processes. Results are comprehensively described and illustrated by a series of examples retrieved from experimental testing on steel and aluminum alloys and allow understanding of the influence of bending on formability.
Published: 2015

20. Insights on the safety of carotenogenic Chlorella vulgaris in rodents

Author: M. Luísa Corvo, Ana Paula Batista, Narcisa M. Bandarra, Anabela Raymundo, Rui Pinto, Joana Lucas, Rogério Mendes, Beatriz Silva-Lima, Diana Duarte, Luísa Gouveia, and Cristina de Mello-Sampayo
Subjects: chemistry.chemical_classification, medicine.medical_specialty, Chlorella vulgaris, Chlorella Vulgaris, food and beverages, Spleen, Orange (colour), Health benefits, Biology, Carotenoids, medicine.anatomical_structure, Biodisposition, Biochemistry, chemistry, Faecal matter, Toxicity, medicine, Histopathology, Food science, Safety, Agronomy and Crop Science, Carotenoid, Microalga
Abstract: Chlorella vulgaris ( Cv ) biomass is widely used as a traditional food in the Orient and its safety for human consumption has been proved. However, carotenogenic biomass (orange), resulting from induced stresses, needs further safety evaluation, which is the aim of this study. The preliminary toxicological characterization of Cv consisted of a single dose (mice), repeated dose studies (mice and rats) and a biodisposition evaluation (rats). No mortalities nor relevant clinical signs or behavioural changes were observed in mice or in rats. The carotenoids in the rat faecal matter suggest that the carotenoids contained in Cv have been absorbed through a potentially saturated transport across the intestinal wall. No safety concerns were identified based on clinical signs, biochemical parameters, and liver and spleen histopathology. No significant differences in food/water intake, blood-pressure, blood glucose levels, glucose tolerance and plasticity of erythrocytes were observed over one month with both supplemented and control animals. The intake of carotenogenic Cv did not reveal any signs of toxicity for doses far exceeding the proposed carotenoid human-diet dose. Therefore these preliminary results suggest that the orange Cv microalgae can be used as a source of carotenoids and could be used for human consumption with possible health benefits.
Published: 2013

21. About the contributors

Author: J. Paulo Davim, Roger White, David Bradley, Nikolai Zhelev, Panos Lazarou, Nikos A. Aspragathos, Fusaomi Nagata, Keisuke Ogiwara, Keigo Watanabe, Zhu Kunpeng, Wong Yoke San, Hong Geok Soon, Prasanta Sahoo, Tapan Kr. Barman, Inderdeep Singh, P.K. Rakesh, Jagannath Malik, V.N. Gaitonde, S.R Karnik, Maria Beatriz Silva, Tânia Marques, and Paulo A.F Martins
Published: 2012

22. Single-point incremental forming of polymers

Author: Tânia Marques, Paolo A.F. Martins, and Maria Beatriz Silva
Subjects: chemistry.chemical_classification, Materials science, Yield (engineering), Polymer, chemistry.chemical_compound, Membrane, chemistry, visual_art, Polyamide, visual_art.visual_art_medium, Polyethylene terephthalate, Formability, Polycarbonate, Single point, Composite material
Abstract: This chapter focuses on new developments in single-point incremental forming (SPIF) that offer the possibility of producing low-cost, small-batch, polymer sheet components at room temperature. The presentation is supported by experimentation with benchmark shapes made from polyvinylchloride (PVC), polyamide (PA), polyethylene terephthalate (PET) and polycarbonate (PC) and is aimed at identifying the formability limits of the process as a function of the major operating parameters. These are further examined by means of a theoretical framework based on membrane analysis with in-plane contact friction forces that is capable of modelling the cold plastic deformation of polymers with pressure-sensitive yield surfaces. Results show that single-point incremental forming of commercial polymer sheets seems promising for the manufacture of complex sheet components with very high depths at room temperature.
Published: 2012

23. Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trialResearch in context

Author: Laure F. Pittet, Nicole L. Messina, Ellie McDonald, Francesca Orsini, Simone Barry, Marc Bonten, John Campbell, Julio Croda, Mariana G. Croda, Margareth Dalcolmo, Kaya Gardiner, Amanda Gwee, Bruno Jardim, Marcus V.G. Lacerda, Michaela Lucas, David J. Lynn, Laurens Manning, Kirsten P. Perrett, Jeffrey J. Post, Cristina Prat-Aymerich, Peter C. Richmond, Jorge L. Rocha, Jesus Rodriguez-Baño, Adilia Warris, Nicholas J. Wood, Andrew Davidson, Nigel Curtis, Tenaya Jamieson, Nicole Messina, Thilanka Morawakage, Susan Perlen, Kirsten Perrett, Laure Pittet, Amber Sastry, Jia Wei Teo, Katherine Lee, Cecilia Moore, Suzanna Vidmar, Rashida Ali, Ross Dunn, Peta Edler, Grace Gell, Casey Goodall, Richard Hall, Ann Krastev, Nathan La, Nick McPhate, Thao Nguyen, Jack Ren, Luke Stevens, Ahmed Alamrousi, Rhian Bonnici, Thanh Dang, Susie Germano, Jenny Hua, Rebecca McElroy, Monica Razmovska, Scott Reddiex, Xiaofang Wang, Jeremy Anderson, Kristy Azzopardi, Vicki Bennett-Wood, Anna Czajko, Nadia Mazarakis, Conor McCafferty, Frances Oppedisano, Belinda Ortika, Casey Pell, Leena Spry, Ryan Toh, Sunitha Velagapudi, Amanda Vlahos, Ashleigh Wee-Hee, Pedro Ramos, Karina De La Cruz, Dinusha Gamage, Anushka Karunanayake, Isabella Mezzetti, Benjamin Ong, Ronita Singh, Enoshini Sooriyarachchi, Suellen Nicholson, Natalie Cain, Rianne Brizuela, Han Huang, Veronica Abruzzo, Morgan Bealing, Patricia Bimboese, Kirsty Bowes, Emma Burrell, Joyce Chan, Jac Cushnahan, Hannah Elborough, Olivia Elkington, Kieran Fahey, Monique Fernandez, Catherine Flynn, Sarah Fowler, Marie Gentile Andrit, Bojana Gladanac, Catherine Hammond, Norine Ma, Sam Macalister, Emmah Milojevic, Jesutofunmi Mojeed, Jill Nguyen, Liz O'Donnell, Nadia Olivier, Isabelle Ooi, Stephanie Reynolds, Lisa Shen, Barb Sherry, Judith Spotswood, Jamie Wedderburn, Angela Younes, Donna Legge, Jason Bell, Jo Cheah, Annie Cobbledick, Kee Lim, Sonja Elia, Lynne Addlem, Anna Bourke, Clare Brophy, Nadine Henare, Narelle Jenkins, Francesca Machingaifa, Skye Miller, Kirsten Mitchell, Sigrid Pitkin, Kate Wall, Paola Villanueva, Nigel Crawford, Wendy Norton, Niki Tan, Thilakavathi Chengodu, Diane Dawson, Victoria Gordon, Tony Korman, Jess O'Bryan, Sophie Agius, Samantha Bannister, Jess Bucholc, Alison Burns, Beatriz Camesella, John Carlin, Marianna Ciaverella, Maxwell Curtis, Stephanie Firth, Christina Guo, Matthew Hannan, Erin Hill, Sri Joshi, Katherine Lieschke, Megan Mathers, Sasha Odoi, Ashleigh Rak, Chris Richards, Leah Steve, Carolyn Stewart, Eva Sudbury, Helen Thomson, Emma Watts, Fiona Williams, Angela Young, Penny Glenn, Andrew Kaynes, Amandine Philippart De Floy, Sandy Buchanan, Thijs Sondag, Ivy Xie, Harriet Edmund, Bridie Byrne, Tom Keeble, Belle Ngien, Fran Noonan, Michelle Wearing-Smith, Alison Clarke, Pemma Davies, Oliver Eastwood, Alric Ellinghaus, Rachid Ghieh, Zahra Hilton, Emma Jennings, Athina Kakkos, Iris Liang, Katie Nicol, Sally O'Callaghan, Helen Osman, Gowri Rajaram, Sophia Ratcliffe, Victoria Rayner, Ashleigh Salmon, Angela Scheppokat, Aimee Stevens, Rebekah Street, Nicholas Toogood, Nicholas Wood, Twinkle Bahaduri, Therese Baulman, Jennifer Byrne, Candace Carter, Mary Corbett, Aiken Dao, Maria Desylva, Andrew Dunn, Evangeline Gardiner, Rosemary Joyce, Rama Kandasamy, Craig Munns, Lisa Pelayo, Ketaki Sharma, Katrina Sterling, Caitlin Uren, Clinton Colaco, Mark Douglas, Kate Hamilton, Adam Bartlett, Brendan McMullan, Pamela Palasanthiran, Phoebe Williams, Justin Beardsley, Nikki Bergant, Renier Lagunday, Kristen Overton, Jeffrey Post, Yasmeen Al-Hindawi, Sarah Barney, Anthony Byrne, Lee Mead, Marshall Plit, David Lynn, Saoirse Benson, Stephen Blake, Rochelle Botten, Tee Yee Chern, Georgina Eden, Liddy Griffith, Jane James, Miriam Lynn, Angela Markow, Domenic Sacca, Natalie Stevens, Steve Wesselingh, Catriona Doran, Alice Sawka, Sue Evans, Louise Goodchild, Christine Heath, Meredith Krieg, Helen Marshall, Mark McMillan, Mary Walker, Peter Richmond, Nelly Amenyogbe, Christina Anthony, Annabelle Arnold, Beth Arrowsmith, Rym Ben-Othman, Sharon Clark, Jemma Dunnill, Nat Eiffler, Krist Ewe, Carolyn Finucane, Lorraine Flynn, Camille Gibson, Lucy Hartnell, Elysia Hollams, Heidi Hutton, Lance Jarvis, Jane Jones, Jan Jones, Karen Jones, Jennifer Kent, Tobias Kollmann, Debbie Lalich, Wenna Lee, Rachel Lim, Sonia McAlister, Fiona McDonald, Andrea Meehan, Asma Minhaj, Lisa Montgomery, Melissa O'Donnell, Jaslyn Ong, Joanne Ong, Kimberley Parkin, Glady Perez, Catherine Power, Shadie Rezazadeh, Holly Richmond, Sally Rogers, Nikki Schultz, Margaret Shave, Patrycja Skut, Lisa Stiglmayer, Alexandra Truelove, Ushma Wadia, Rachael Wallace, Justin Waring, Michelle England, Erin Latkovic, Susan Herrmann, Marcus Lacerda, Paulo Henrique Andrade, Fabiane Bianca Barbosa, Dayanne Barros, Larissa Brasil, Ana Greyce Capella, Ramon Castro, Erlane Costa, Dilcimar de Souza, Maianne Dias, José Dias, Klenilson Ferreira, Paula Figueiredo, Thamires Freitas, Ana Carolina Furtado, Larissa Gama, Vanessa Godinho, Cintia Gouy, Daniele Hinojosa, Tyane Jardim, Joel Junior, Augustto Lima, Bernardo Maia, Adriana Marins, Kelry Mazurega, Tercilene Medeiros, Rosangela Melo, Marinete Moraes, Elizandra Nascimento, Juliana Neves, Maria Gabriela Oliveira, Thais Oliveira, Ingrid Oliveira, Arthur Otsuka, Rayssa Paes, Handerson Pereira, Gabrielle Pereira, Christiane Prado, Evelyn Queiroz, Laleyska Rodrigues, Bebeto Rodrigues, Vanderson Sampaio, Anna Gabriela Santos, Daniel Santos, Tilza Santos, Evelyn Santos, Ariandra Sartim, Ana Beatriz Silva, Juliana Silva, Emanuelle Silva, Mariana Simão, Caroline Soares, Antonny Sousa, Alexandre Trindade, Fernando Val, Adria Vasconcelos, Heline Vasconcelos, Carolinne Abreu, Katya Martinez Almeida, Camila Bitencourt de Andrade, Jhenyfer Thalyta Campos Angelo, Ghislaine Gonçalvez de Araújo Arcanjo, Bianca Maria Silva Menezes Arruda, Wellyngthon Espindola Ayala, Adelita Agripina Refosco Barbosa, Felipe Zampieri Vieira Batista, Fabiani de Morais Batista, Miriam de Jesus Costa, Mariana Garcia Croda, Lais Alves da Cruz, Roberta Carolina Pereira Diogo, Rodrigo Cezar Dutra Escobar, Iara Rodrigues Fernandes, Leticia Ramires Figueiredo, Leandro Galdino Cavalcanti Gonçalves, Sarita Lahdo, Joyce dos Santos Lencina, Guilherme Teodoro de Lima, Bruna Tayara LEOPOLDINA MEIRELES, Debora Quadros Moreira, Lilian Batista Silva Muranaka, Adriely de Oliveira, Karla Regina Warszawski de Oliveira, Matheus Vieira de Oliveira, Roberto Dias de Oliveira, Andrea Antonia Souza de Almeida dos Reis Pereira, Marco Puga, Caroliny Veron Ramos, Thaynara Haynara Souza da Rosa, Karla Lopes dos Santos, Claudinalva Ribeiro dos Santos, Dyenyffer Stéffany Leopoldina dos Santos, Karina Marques Santos, Paulo César Pereira da Silva, Paulo Victor Rocha da Silva, Débora dos Santos Silva, Patricia Vieira da Silva, Bruno Freitas da Rosa Soares, Mariana Gazzoni Sperotto, Mariana Mayumi Tadokoro, Daniel Tsuha, Hugo Miguel Ramos Vieira, Margareth Maria Pretti Dalcolmo, Cíntia Maria Lopes Alves da Paixão, Gabriela Corrêa E Castro, Simone Silva Collopy, Renato da Costa Silva, Samyra Almeida da Silveira, Alda Maria Da-Cruz, Alessandra Maria da Silva Passos de Carvalho, Rita de Cássia Batista, Maria Luciana Silva De Freitas, Aline Gerhardt de Oliveira Ferreira, Ana Paula Conceição de Souza, Paola Cerbino Doblas, Ayla Alcoforado da Silva dos Santos, Vanessa Cristine de Moraes dos Santos, Dayane Alves dos Santos Gomes, Anderson Lage Fortunato, Adriano Gomes-Silva, Monique Pinto Gonçalves, Paulo Leandro Garcia Meireless Junior, Estela Martins da Costa Carvalho, Fernando do Couto Motta, Ligia Maria Olivo de Mendonça, Girlene dos Santos Pandine, Rosa Maria Plácido Pereira, Ivan Ramos Maia, Jorge Luiz da Rocha, João Victor Paiva Romano, Glauce dos Santos, Erica Fernandes da Silva, Marilda Agudo Mendonça Teixeira de Siqueira, Ágatha Cristinne Prudêncio Soares, Sandra Franch Arroyo, Henny Ophorst-den Besten, Anna Boon, Karin M. Brakke, Axel Janssen, Marijke A.H. Koopmans, Toos Lemmens, Titia Leurink, Engelien Septer-Bijleveld, Kimberly Stadhouders, Darren Troeman, Marije van der Waal, Marjoleine van Opdorp, Nicolette van Sluis, Beatrijs Wolters, Jan Kluytmans, Jannie Romme, Wouter van den Bijllaardt, Linda van Mook, M.M.L (Miranda) van Rijen, P.M.G. Filius, Jet Gisolf, Frances Greven, Danique Huijbens, Robert Jan Hassing, R.C. Pon, Lieke Preijers, J.H. van Leusen, Harald Verheij, Wim Boersma, Evelien Brans, Paul Kloeg, Kitty Molenaar-Groot, Nhat Khanh Nguyen, Nienke Paternotte, Anke Rol, Lida Stooper, Helga Dijkstra, Esther Eggenhuizen, Lucas Huijs, Simone Moorlag, Mihai Netea, Eva Pranger, Esther Taks, Jaap ten Oever, Rob ter Heine, Kitty Blauwendraat, Bob Meek, Isil Erkaya, Houda Harbech, Nienke Roescher, Rifka Peeters, Menno te Riele, Carmen Zhou, Esther Calbo, Cristina Badia Marti, Emma Triviño Palomares, Tomás Perez Porcuna, Anabel Barriocanal, Ana Maria Barriocanal, Irma Casas, Jose Dominguez, Maria Esteve, Alicia Lacoma, Irene Latorre, Gemma Molina, Barbara Molina, Antoni Rosell, Sandra Vidal, Lydia Barrera, Natalia Bustos, Ines Portillo Calderón, David Gutierrez Campos, Jose Manuel Carretero, Angel Dominguez Castellano, Renato Compagnone, Encarnacion Ramirez de Arellano, Almudena de la Serna, Maria Dolores del Toro Lopez, Marie-Alix Clement Espindola, Ana Belen Martin Gutierrez, Alvaro Pascual Hernandez, Virginia Palomo Jiménez, Elisa Moreno, Nicolas Navarrete, Teresa Rodriguez Paño, Jesús Rodríguez-Baño, Enriqueta Tristán, Maria Jose Rios Villegas, Atsegiñe Canga Garces, Erika Castro Amo, Raquel Coya Guerrero, Josune Goikoetxea, Leticia Jorge, Cristina Perez, María Carmen Fariñas Álvarez, Manuel Gutierrez Cuadra, Francisco Arnaiz de las Revillas Almajano, Pilar Bohedo Garcia, Teresa Giménez Poderos, Claudia González Rico, Blanca Sanchez, Olga Valero, Noelia Vega, Anna Barnes, Helen Catterick, Tim Cranston, Phoebe Dawe, Emily Fletcher, Liam Fouracre, Alison Gifford, Neil Gow, John Kirkwood, Christopher Martin, Amy McAnew, Marcus Mitchell, Georgina Newman, Abby O'Connell, Jakob Onysk, Lynne Quinn, Shelley Rhodes, Samuel Stone, Lorrie Symons, Harry Tripp, Darcy Watkins, Bethany Whale, Alex Harding, Gemma Lockhart, Kate Sidaway-Lee, Sam Hilton, Sarah Manton, Daniel Webber-Rookes, Rachel Winder, James Moore, Freya Bateman, Michael Gibbons, Bridget Knight, Julie Moss, Sarah Statton, Josephine Studham, Lydia Hall, Will Moyle, and Tamsin Venton
Subjects: Bacille Calmette-Guérin (BCG) vaccine, Immunity, Heterologous, Health personnel, Randomised controlled trial, Primary prevention, Medicine (General), R5-920
Abstract: Summary: Background: Bacille Calmette-Guérin (BCG) vaccination has off-target (non-specific) effects that are associated with protection against unrelated infections and decreased all-cause mortality in infants. We aimed to determine whether BCG vaccination prevents febrile and respiratory infections in adults. Methods: This randomised controlled phase 3 trial was done in 36 healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom. Healthcare workers were randomised to receive BCG-Denmark (single 0.1 ml intradermal injection) or no BCG in a 1:1 ratio using a web-based procedure, stratified by stage, site, age, and presence of co-morbidity. The difference in occurrence of febrile or respiratory illness were measured over 12 months (prespecified secondary outcome) using the intention-to-treat (ITT) population. This trial is registered with ClinicalTrials.gov, NCT04327206. Findings: Between March 30, 2020, and April 1, 2021, 6828 healthcare workers were randomised to BCG-Denmark (n = 3417) or control (n = 3411; no intervention or placebo) groups. The 12-month adjusted estimated risk of ≥1 episode of febrile or respiratory illness was 66.8% in the BCG group (95% CI 65.3%–68.2%), compared with 63.4% in the control group (95% CI 61.8%–65.0%), a difference of +3.4 percentage points (95% CI +1.3% to +5.5%; p 0.002). The adjusted estimated risk of a severe episode (defined as being incapacitated for ≥3 consecutive days or hospitalised) was 19.4% in the BCG group (95% CI 18.0%–20.7%), compared with 18.8% in the control group (95% CI 17.4%–20.2%) a difference of +0.6 percentage points (95% CI −1.3% to +2.5%; p 0.6). Both groups had a similar number of episodes of illness, pneumonia, and hospitalisation. There were three deaths, all in the control group. There were no safety concerns following BCG vaccination. Interpretation: In contrast to the beneficial off-target effects reported following neonatal BCG in infants, a small increased risk of symptomatic febrile or respiratory illness was observed in the 12 months following BCG vaccination in adults. There was no evidence of a difference in the risk of severe disease. Funding: Bill & Melinda Gates Foundation, Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare, the National Health and Medical Research Council, the Swiss National Science Foundation and individual donors.
Published: 2024
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24. Specific and off-target immune responses following COVID-19 vaccination with ChAdOx1-S and BNT162b2 vaccines—an exploratory sub-study of the BRACE trialResearch in context

Author: Nicole L. Messina, Susie Germano, Rebecca McElroy, Rhian Bonnici, Branka Grubor-Bauk, David J. Lynn, Ellie McDonald, Suellen Nicholson, Kirsten P. Perrett, Laure F. Pittet, Rajeev Rudraraju, Natalie E. Stevens, Kanta Subbarao, Nigel Curtis, Andrew Davidson, Kaya Gardiner, Amanda Gwee, Tenaya Jamieson, Nicole Messina, Thilanka Morawakage, Susan Perlen, Kirsten Perrett, Laure Pittet, Amber Sastry, Jia Wei Teo, Francesca Orsini, Katherine Lee, Cecilia Moore, Suzanna Vidmar, Rashida Ali, Ross Dunn, Peta Edler, Grace Gell, Casey Goodall, Richard Hall, Ann Krastev, Nathan La, Nick McPhate, Thao Nguyen, Jack Ren, Luke Stevens, Ahmed Alamrousi, Thanh Dang, Jenny Hua, Monica Razmovska, Scott Reddiex, Xiaofang Wang, Jeremy Anderson, Kristy Azzopardi, Vicki Bennett-Wood, Anna Czajko, Nadia Mazarakis, Conor McCafferty, Frances Oppedisano, Belinda Ortika, Casey Pell, Leena Spry, Ryan Toh, Sunitha Velagapudi, Amanda Vlahos, Ashleigh Wee-Hee, Pedro Ramos, Karina De La Cruz, Dinusha Gamage, Anushka Karunanayake, Isabella Mezzetti, Benjamin Ong, Ronita Singh, Enoshini Sooriyarachchi, Natalie Cain, Rianne Brizuela, Han Huang, Veronica Abruzzo, Morgan Bealing, Patricia Bimboese, Kirsty Bowes, Emma Burrell, Joyce Chan, Jac Cushnahan, Hannah Elborough, Olivia Elkington, Kieran Fahey, Monique Fernandez, Catherine Flynn, Sarah Fowler, Marie Gentile Andrit, Bojana Gladanac, Catherine Hammond, Norine Ma, Sam Macalister, Emmah Milojevic, Jesutofunmi Mojeed, Jill Nguyen, Liz O’Donnell, Nadia Olivier, Isabelle Ooi, Stephanie Reynolds, Lisa Shen, Barb Sherry, Judith Spotswood, Jamie Wedderburn, Angela Younes, Donna Legge, Jason Bell, Jo Cheah, Annie Cobbledick, Kee Lim, Sonja Elia, Lynne Addlem, Anna Bourke, Clare Brophy, Nadine Henare, Narelle Jenkins, Francesca Machingaifa, Skye Miller, Kirsten Mitchell, Sigrid Pitkin, Kate Wall, Paola Villanueva, Nigel Crawford, Wendy Norton, Niki Tan, Thilakavathi Chengodu, Diane Dawson, Victoria Gordon, Tony Korman, Jess O’Bryan, Sophie Agius, Samantha Bannister, Jess Bucholc, Alison Burns, Beatriz Camesella, John Carlin, Marianna Ciaverella, Maxwell Curtis, Stephanie Firth, Christina Guo, Matthew Hannan, Erin Hill, Sri Joshi, Katherine Lieschke, Megan Mathers, Sasha Odoi, Ashleigh Rak, Chris Richards, Leah Steve, Carolyn Stewart, Eva Sudbury, Helen Thomson, Emma Watts, Fiona Williams, Angela Young, Penny Glenn, Andrew Kaynes, Amandine Philippart De Floy, Sandy Buchanan, Thijs Sondag, Ivy Xie, Harriet Edmund, Bridie Byrne, Tom Keeble, Belle Ngien, Fran Noonan, Michelle Wearing-Smith, Alison Clarke, Pemma Davies, Oliver Eastwood, Alric Ellinghaus, Rachid Ghieh, Zahra Hilton, Emma Jennings, Athina Kakkos, Iris Liang, Katie Nicol, Sally O’Callaghan, Helen Osman, Gowri Rajaram, Sophia Ratcliffe, Victoria Rayner, Ashleigh Salmon, Angela Scheppokat, Aimee Stevens, Rebekah Street, Nicholas Toogood, Nicholas Wood, Twinkle Bahaduri, Therese Baulman, Jennifer Byrne, Candace Carter, Mary Corbett, Aiken Dao, Maria Desylva, Andrew Dunn, Evangeline Gardiner, Rosemary Joyce, Rama Kandasamy, Craig Munns, Lisa Pelayo, Ketaki Sharma, Katrina Sterling, Caitlin Uren, Clinton Colaco, Mark Douglas, Kate Hamilton, Adam Bartlett, Brendan McMullan, Pamela Palasanthiran, Phoebe Williams, Justin Beardsley, Nikki Bergant, Renier Lagunday, Kristen Overton, Jeffrey Post, Yasmeen Al-Hindawi, Sarah Barney, Anthony Byrne, Lee Mead, Marshall Plit, David Lynn, Saoirse Benson, Stephen Blake, Rochelle Botten, Tee Yee Chern, Georgina Eden, Liddy Griffith, Jane James, Miriam Lynn, Angela Markow, Domenic Sacca, Natalie Stevens, Steve Wesselingh, Catriona Doran, Simone Barry, Alice Sawka, Sue Evans, Louise Goodchild, Christine Heath, Meredith Krieg, Helen Marshall, Mark McMillan, Mary Walker, Peter Richmond, Nelly Amenyogbe, Christina Anthony, Annabelle Arnold, Beth Arrowsmith, Rym Ben-Othman, Sharon Clark, Jemma Dunnill, Nat Eiffler, Krist Ewe, Carolyn Finucane, Lorraine Flynn, Camille Gibson, Lucy Hartnell, Elysia Hollams, Heidi Hutton, Lance Jarvis, Jane Jones, Jan Jones, Karen Jones, Jennifer Kent, Tobias Kollmann, Debbie Lalich, Wenna Lee, Rachel Lim, Sonia McAlister, Fiona McDonald, Andrea Meehan, Asma Minhaj, Lisa Montgomery, Melissa O’Donnell, Jaslyn Ong, Joanne Ong, Kimberley Parkin, Glady Perez, Catherine Power, Shadie Rezazadeh, Holly Richmond, Sally Rogers, Nikki Schultz, Margaret Shave, Patrycja Skut, Lisa Stiglmayer, Alexandra Truelove, Ushma Wadia, Rachael Wallace, Justin Waring, Michelle England, Erin Latkovic, Laurens Manning, Susan Herrmann, Michaela Lucas, Marcus Lacerda, Paulo Henrique Andrade, Fabiane Bianca Barbosa, Dayanne Barros, Larissa Brasil, Ana Greyce Capella, Ramon Castro, Erlane Costa, Dilcimar de Souza, Maianne Dias, José Dias, Klenilson Ferreira, Paula Figueiredo, Thamires Freitas, Ana Carolina Furtado, Larissa Gama, Vanessa Godinho, Cintia Gouy, Daniele Hinojosa, Bruno Jardim, Tyane Jardim, Joel Junior, Augustto Lima, Bernardo Maia, Adriana Marins, Kelry Mazurega, Tercilene Medeiros, Rosangela Melo, Marinete Moraes, Elizandra Nascimento, Juliana Neves, Maria Gabriela Oliveira, Thais Oliveira, Ingrid Oliveira, Arthur Otsuka, Rayssa Paes, Handerson Pereira, Gabrielle Pereira, Christiane Prado, Evelyn Queiroz, Laleyska Rodrigues, Bebeto Rodrigues, Vanderson Sampaio, Anna Gabriela Santos, Daniel Santos, Tilza Santos, Evelyn Santos, Ariandra Sartim, Ana Beatriz Silva, Juliana Silva, Emanuelle Silva, Mariana Simão, Caroline Soares, Antonny Sousa, Alexandre Trindade, Fernando Val, Adria Vasconcelos, Heline Vasconcelos, Julio Croda, Carolinne Abreu, Katya Martinez Almeida, Camila Bitencourt de Andrade, Jhenyfer Thalyta Campos Angelo, Ghislaine Gonçalvez de Araújo Arcanjo, Bianca Maria Silva Menezes Arruda, Wellyngthon Espindola Ayala, Adelita Agripina Refosco Barbosa, Felipe Zampieri Vieira Batista, Fabiani de Morais Batista, Miriam de Jesus Costa, Mariana Garcia Croda, Lais Alves da Cruz, Roberta Carolina Pereira Diogo, Rodrigo Cezar Dutra Escobar, Iara Rodrigues Fernandes, Leticia Ramires Figueiredo, Leandro Galdino Cavalcanti Gonçalves, Sarita Lahdo, Joyce dos Santos Lencina, Guilherme Teodoro de Lima, Larissa Santos Matos, Bruna Tayara Leopoldina Meireles, Debora Quadros Moreira, Lilian Batista Silva Muranaka, Adriely de Oliveira, Karla Regina Warszawski de Oliveira, Matheus Vieira de Oliveira, Roberto Dias de Oliveira, Andrea Antonia Souza de Almeida dos Reis Pereira, Marco Puga, Caroliny Veron Ramos, Thaynara Haynara Souza da Rosa, Karla Lopes dos Santos, Claudinalva Ribeiro dos Santos, Dyenyffer Stéffany Leopoldina dos Santos, Karina Marques Santos, Paulo César Pereira da Silva, Paulo Victor Rocha da Silva, Débora dos Santos Silva, Patricia Vieira da Silva, Bruno Freitas da Rosa Soares, Mariana Gazzoni Sperotto, Mariana Mayumi Tadokoro, Daniel Tsuha, Hugo Miguel Ramos Vieira, Margareth Maria Pretti Dalcolmo, Cíntia Maria Lopes Alves da Paixão, Gabriela Corrêa E Castro, Simone Silva Collopy, Renato da Costa Silva, Samyra Almeida da Silveira, Alda Maria Da-Cruz, Alessandra Maria da Silva Passos de Carvalho, Rita de Cássia Batista, Maria Luciana Silva De Freitas, Aline Gerhardt de Oliveira Ferreira, Ana Paula Conceição de Souza, Paola Cerbino Doblas, Ayla Alcoforado da Silva dos Santos, Vanessa Cristine de Moraes dos Santos, Dayane Alves dos Santos Gomes, Anderson Lage Fortunato, Adriano Gomes-Silva, Monique Pinto Gonçalves, Paulo Leandro Garcia Meireless Junior, Estela Martins da Costa Carvalho, Fernando do Couto Motta, Ligia Maria Olivo de Mendonça, Girlene dos Santos Pandine, Rosa Maria Plácido Pereira, Ivan Ramos Maia, Jorge Luiz da Rocha, João Victor Paiva Romano, Glauce dos Santos, Erica Fernandes da Silva, Marilda Agudo Mendonça Teixeira de Siqueira, Ágatha Cristinne Prudêncio Soares, Marc Bonten, Sandra Franch Arroyo, Henny Ophorst-den Besten, Anna Boon, Karin M. Brakke, Axel Janssen, Marijke A.H. Koopmans, Toos Lemmens, Titia Leurink, Cristina Prat-Aymerich, Engelien Septer-Bijleveld, Kimberly Stadhouders, Darren Troeman, Marije van der Waal, Marjoleine van Opdorp, Nicolette van Sluis, Beatrijs Wolters, Jan Kluytmans, Jannie Romme, Wouter van den Bijllaardt, Linda van Mook, M.M.L (Miranda) van Rijen, Margreet Filius, Jet Gisolf, Frances Greven, Danique Huijbens, Robert Jan Hassing, Roos Pon, Lieke Preijers, Joke van Leusen, Harald Verheij, Wim Boersma, Evelien Brans, Paul Kloeg, Kitty Molenaar-Groot, Nhat Khanh Nguyen, Nienke Paternotte, Anke Rol, Lida Stooper, Helga Dijkstra, Esther Eggenhuizen, Lucas Huijs, Simone Moorlag, Mihai Netea, Eva Pranger, Esther Taks, Jaap ten Oever, Rob ter Heine, Kitty Blauwendraat, Bob Meek, Isil Erkaya, Houda Harbech, Nienke Roescher, Rifka Peeters, Menno te Riele, Carmen Zhou, Esther Calbo, Cristina Badia Marti, Emma Triviño Palomares, Tomás Perez Porcuna, Anabel Barriocanal, Ana Maria Barriocanal, Irma Casas, Jose Dominguez, Maria Esteve, Alicia Lacoma, Irene Latorre, Gemma Molina, Barbara Molina, Antoni Rosell, Sandra Vidal, Lydia Barrera, Natalia Bustos, Ines Portillo Calderón, David Gutierrez Campos, Jose Manuel Carretero, Angel Dominguez Castellano, Renato Compagnone, Encarnacion Ramirez de Arellano, Almudena de la Serna, Maria Dolores del Toro Lopez, Marie-Alix Clement Espindola, Ana Belen Martin Gutierrez, Alvaro Pascual Hernandez, Virginia Palomo Jiménez, Elisa Moreno, Nicolas Navarrete, Teresa Rodriguez Paño, Jesús Rodríguez-Baño, Enriqueta Tristán, Maria Jose Rios Villegas, Atsegiñe Canga Garces, Erika Castro Amo, Raquel Coya Guerrero, Josune Goikoetxea, Leticia Jorge, Cristina Perez, María Carmen Fariñas Álvarez, Manuel Gutierrez Cuadra, Francisco Arnaiz de las Revillas Almajano, Pilar Bohedo Garcia, Teresa Giménez Poderos, Claudia González Rico, Blanca Sanchez, Olga Valero, Noelia Vega, John Campbell, Anna Barnes, Helen Catterick, Tim Cranston, Phoebe Dawe, Emily Fletcher, Liam Fouracre, Alison Gifford, John Kirkwood, Christopher Martin, Amy McAnew, Marcus Mitchell, Georgina Newman, Abby O’Connell, Jakob Onysk, Lynne Quinn, Shelley Rhodes, Samuel Stone, Lorrie Symons, Harry Tripp, Adilia Warris, Darcy Watkins, Bethany Whale, Alex Harding, Gemma Lockhart, Kate Sidaway-Lee, Sam Hilton, Sarah Manton, Daniel Webber-Rookes, Rachel Winder, James Moore, Freya Bateman, Michael Gibbons, Bridget Knight, Julie Moss, Sarah Statton, Josephine Studham, Lydia Hall, Will Moyle, and Tamsin Venton
Subjects: Vaccine, Off-target, Immunoregulation, Cytokine, SARS-CoV-2, Heterologous immunity, Medicine, Medicine (General), R5-920
Abstract: Summary: Background: The COVID-19 pandemic led to the rapid development and deployment of several highly effective vaccines against SARS-CoV-2. Recent studies suggest that these vaccines may also have off-target effects on the immune system. We sought to determine and compare the off-target effects of the adenovirus vector ChAdOx1-S (Oxford-AstraZeneca) and modified mRNA BNT162b2 (Pfizer-BioNTech) vaccines on immune responses to unrelated pathogens. Methods: Prospective sub-study within the BRACE trial. Blood samples were collected from 284 healthcare workers before and 28 days after ChAdOx1-S or BNT162b2 vaccination. SARS-CoV-2-specific antibodies were measured using ELISA, and whole blood cytokine responses to specific (SARS-CoV-2) and unrelated pathogen stimulation were measured by multiplex bead array. Findings: Both vaccines induced robust SARS-CoV-2 specific antibody and cytokine responses. ChAdOx1-S vaccination increased cytokine responses to heat-killed (HK) Candida albicans and HK Staphylococcus aureus and decreased cytokine responses to HK Escherichia coli and BCG. BNT162b2 vaccination decreased cytokine response to HK E. coli and had variable effects on cytokine responses to BCG and resiquimod (R848). After the second vaccine dose, BNT162b2 recipients had greater specific and off-target cytokine responses than ChAdOx1-S recipients. Interpretation: ChAdOx1-S and BNT162b2 vaccines alter cytokine responses to unrelated pathogens, indicative of potential off-target effects. The specific and off-target effects of these vaccines differ in their magnitude and breadth. The clinical relevance of these findings is uncertain and needs further study. Funding: Bill & Melinda Gates Foundation, National Health and Medical Research Council, Swiss National Science Foundation and the Melbourne Children’s. BRACE trial funding is detailed in acknowledgements.
Published: 2024
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25. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context

Author: Laure F. Pittet, Cecilia L. Moore, Ellie McDonald, Simone Barry, Marc Bonten, John Campbell, Julio Croda, Margareth Dalcolmo, Andrew Davidson, Mark W. Douglas, Kaya Gardiner, Amanda Gwee, Bruno Jardim, Marcus V.G. Lacerda, Michaela Lucas, David J. Lynn, Laurens Manning, Roberto D. de Oliveira, Kirsten P. Perrett, Cristina Prat-Aymerich, Peter C. Richmond, Jorge L. Rocha, Jesus Rodriguez-Baño, Adilia Warris, Nicholas J. Wood, Nicole L. Messina, Nigel Curtis, Tenaya Jamieson, Nicole Messina, Thilanka Morawakage, Susan Perlen, Kirsten Perrett, Laure Pittet, Amber Sastry, Jia Wei Teo, Francesca Orsini, Katherine Lee, Cecilia Moore, Suzanna Vidmar, Rashida Ali, Ross Dunn, Peta Edler, Grace Gell, Casey Goodall, Richard Hall, Ann Krastev, Nathan La, Nick McPhate, Thao Nguyen, Jack Ren, Luke Stevens, Ahmed Alamrousi, Rhian Bonnici, Thanh Dang, Susie Germano, Jenny Hua, Rebecca McElroy, Monica Razmovska, Scott Reddiex, Xiaofang Wang, Jeremy Anderson, Kristy Azzopardi, Vicki Bennett-Wood, Anna Czajko, Nadia Mazarakis, Conor McCafferty, Frances Oppedisano, Belinda Ortika, Casey Pell, Leena Spry, Ryan Toh, Sunitha Velagapudi, Amanda Vlahos, Ashleigh Wee-Hee, Pedro Ramos, Karina De La Cruz, Dinusha Gamage, Anushka Karunanayake, Isabella Mezzetti, Benjamin Ong, Ronita Singh, Enoshini Sooriyarachchi, Suellen Nicholson, Natalie Cain, Rianne Brizuela, Han Huang, Veronica Abruzzo, Morgan Bealing, Patricia Bimboese, Kirsty Bowes, Emma Burrell, Joyce Chan, Jac Cushnahan, Hannah Elborough, Olivia Elkington, Kieran Fahey, Monique Fernandez, Catherine Flynn, Sarah Fowler, Marie Gentile Andrit, Bojana Gladanac, Catherine Hammond, Norine Ma, Sam Macalister, Emmah Milojevic, Jesutofunmi Mojeed, Jill Nguyen, Liz O'Donnell, Nadia Olivier, Isabelle Ooi, Stephanie Reynolds, Lisa Shen, Barb Sherry, Judith Spotswood, Jamie Wedderburn, Angela Younes, Donna Legge, Jason Bell, Jo Cheah, Annie Cobbledick, Kee Lim, Sonja Elia, Lynne Addlem, Anna Bourke, Clare Brophy, Nadine Henare, Narelle Jenkins, Francesca Machingaifa, Skye Miller, Kirsten Mitchell, Sigrid Pitkin, Kate Wall, Paola Villanueva, Nigel Crawford, Wendy Norton, Niki Tan, Thilakavathi Chengodu, Diane Dawson, Victoria Gordon, Tony Korman, Jess O'Bryan, Sophie Agius, Samantha Bannister, Jess Bucholc, Alison Burns, Beatriz Camesella, John Carlin, Marianna Ciaverella, Maxwell Curtis, Stephanie Firth, Christina Guo, Matthew Hannan, Erin Hill, Sri Joshi, Katherine Lieschke, Megan Mathers, Sasha Odoi, Ashleigh Rak, Chris Richards, Leah Steve, Carolyn Stewart, Eva Sudbury, Helen Thomson, Emma Watts, Fiona Williams, Angela Young, Penny Glenn, Andrew Kaynes, Amandine Philippart De Floy, Sandy Buchanan, Thijs Sondag, Ivy Xie, Harriet Edmund, Bridie Byrne, Tom Keeble, Belle Ngien, Fran Noonan, Michelle Wearing-Smith, Alison Clarke, Pemma Davies, Oliver Eastwood, Alric Ellinghaus, Rachid Ghieh, Zahra Hilton, Emma Jennings, Athina Kakkos, Iris Liang, Katie Nicol, Sally O'Callaghan, Helen Osman, Gowri Rajaram, Sophia Ratcliffe, Victoria Rayner, Ashleigh Salmon, Angela Scheppokat, Aimee Stevens, Rebekah Street, Nicholas Toogood, Nicholas Wood, Twinkle Bahaduri, Therese Baulman, Jennifer Byrne, Candace Carter, Mary Corbett, Aiken Dao, Maria Desylva, Andrew Dunn, Evangeline Gardiner, Rosemary Joyce, Rama Kandasamy, Craig Munns, Lisa Pelayo, Ketaki Sharma, Katrina Sterling, Caitlin Uren, Clinton Colaco, Mark Douglas, Kate Hamilton, Adam Bartlett, Brendan McMullan, Pamela Palasanthiran, Phoebe Williams, Justin Beardsley, Nikki Bergant, Renier Lagunday, Kristen Overton, Jeffrey Post, Yasmeen Al-Hindawi, Sarah Barney, Anthony Byrne, Lee Mead, Marshall Plit, David Lynn, Saoirse Benson, Stephen Blake, Rochelle Botten, Tee Yee Chern, Georgina Eden, Liddy Griffith, Jane James, Miriam Lynn, Angela Markow, Domenic Sacca, Natalie Stevens, Steve Wesselingh, Catriona Doran, Alice Sawka, Sue Evans, Louise Goodchild, Christine Heath, Meredith Krieg, Helen Marshall, Mark McMillan, Mary Walker, Peter Richmond, Nelly Amenyogbe, Christina Anthony, Annabelle Arnold, Beth Arrowsmith, Rym Ben-Othman, Sharon Clark, Jemma Dunnill, Nat Eiffler, Krist Ewe, Carolyn Finucane, Lorraine Flynn, Camille Gibson, Lucy Hartnell, Elysia Hollams, Heidi Hutton, Lance Jarvis, Jane Jones, Jan Jones, Karen Jones, Jennifer Kent, Tobias Kollmann, Debbie Lalich, Wenna Lee, Rachel Lim, Sonia McAlister, Fiona McDonald, Andrea Meehan, Asma Minhaj, Lisa Montgomery, Melissa O'Donnell, Jaslyn Ong, Joanne Ong, Kimberley Parkin, Glady Perez, Catherine Power, Shadie Rezazadeh, Holly Richmond, Sally Rogers, Nikki Schultz, Margaret Shave, Patrycja Skut, Lisa Stiglmayer, Alexandra Truelove, Ushma Wadia, Rachael Wallace, Justin Waring, Michelle England, Erin Latkovic, Susan Herrmann, Marcus Lacerda, Paulo Henrique Andrade, Fabiane Bianca Barbosa, Dayanne Barros, Larissa Brasil, Ana Greyce Capella, Ramon Castro, Erlane Costa, Dilcimar de Souza, Maianne Dias, José Dias, Klenilson Ferreira, Paula Figueiredo, Thamires Freitas, Ana Carolina Furtado, Larissa Gama, Vanessa Godinho, Cintia Gouy, Daniele Hinojosa, Tyane Jardim, Joel Junior, Augustto Lima, Bernardo Maia, Adriana Marins, Kelry Mazurega, Tercilene Medeiros, Rosangela Melo, Marinete Moraes, Elizandra Nascimento, Juliana Neves, Maria Gabriela Oliveira, Thais Oliveira, Ingrid Oliveira, Arthur Otsuka, Rayssa Paes, Handerson Pereira, Gabrielle Pereira, Christiane Prado, Evelyn Queiroz, Laleyska Rodrigues, Bebeto Rodrigues, Vanderson Sampaio, Anna Gabriela Santos, Daniel Santos, Tilza Santos, Evelyn Santos, Ariandra Sartim, Ana Beatriz Silva, Juliana Silva, Emanuelle Silva, Mariana Simão, Caroline Soares, Antonny Sousa, Alexandre Trindade, Fernando Val, Adria Vasconcelos, Heline Vasconcelos, Carolinne Abreu, Katya Martinez Almeida, Camila Bitencourt de Andrade, Jhenyfer Thalyta Campos Angelo, Ghislaine Gonçalvez de Araújo Arcanjo, Bianca Maria Silva Menezes Arruda, Wellyngthon Espindola Ayala, Adelita Agripina Refosco Barbosa, Felipe Zampieri Vieira Batista, Fabiani de Morais Batista, Miriam de Jesus Costa, Mariana Garcia Croda, Lais Alves da Cruz, Roberta Carolina Pereira Diogo, Rodrigo Cezar Dutra Escobar, Iara Rodrigues Fernandes, Leticia Ramires Figueiredo, Leandro Galdino Cavalcanti Gonçalves, Sarita Lahdo, Joyce dos Santos Lencina, Guilherme Teodoro de Lima, Larissa Santos Matos, Bruna Tayara Leopoldina Meireles, Debora Quadros Moreira, Lilian Batista Silva Muranaka, Adriely de Oliveira, Karla Regina Warszawski de Oliveira, Matheus Vieira de Oliveira, Roberto Dias de Oliveira, Andrea Antonia Souza de Almeida dos Reis Pereira, Marco Puga, Caroliny Veron Ramos, Thaynara Haynara Souza da Rosa, Karla Lopes dos Santos, Claudinalva Ribeiro dos Santos, Dyenyffer Stéffany Leopoldina dos Santos, Karina Marques Santos, Paulo César Pereira da Silva, Paulo Victor Rocha da Silva, Débora dos Santos Silva, Patricia Vieira da Silva, Bruno Freitas da Rosa Soares, Mariana Gazzoni Sperotto, Mariana Mayumi Tadokoro, Daniel Tsuha, Hugo Miguel Ramos Vieira, Margareth Maria Pretti Dalcolmo, Cíntia Maria Lopes Alves da Paixão, Gabriela Corrêa E Castro, Simone Silva Collopy, Renato da Costa Silva, Samyra Almeida da Silveira, Alda Maria Da-Cruz, Alessandra Maria da Silva Passos de Carvalho, Rita de Cássia Batista, Maria Luciana Silva De Freitas, Aline Gerhardt de Oliveira Ferreira, Ana Paula Conceição de Souza, Paola Cerbino Doblas, Ayla Alcoforado da Silva dos Santos, Vanessa Cristine de Moraes dos Santos, Dayane Alves dos Santos Gomes, Anderson Lage Fortunato, Adriano Gomes-Silva, Monique Pinto Gonçalves, Paulo Leandro Garcia Meireless Junior, Estela Martins da Costa Carvalho, Fernando do Couto Motta, Ligia Maria Olivo de Mendonça, Girlene dos Santos Pandine, Rosa Maria Plácido Pereira, Ivan Ramos Maia, Jorge Luiz da Rocha, João Victor Paiva Romano, Glauce dos Santos, Erica Fernandes da Silva, Marilda Agudo Mendonça Teixeira de Siqueira, Ágatha Cristinne Prudêncio Soares, Sandra Franch Arroyo, Henny Ophorst-den Besten, Anna Boon, Karin M. Brakke, Axel Janssen, Marijke A.H. Koopmans, Toos Lemmens, Titia Leurink, Engelien Septer-Bijleveld, Kimberly Stadhouders, Darren Troeman, Marije van der Waal, Marjoleine van Opdorp, Nicolette van Sluis, Beatrijs Wolters, Jan Kluytmans, Jannie Romme, Wouter van den Bijllaardt, Linda van Mook, M.M.L (Miranda) van Rijen, P.M.G. Filius, Jet Gisolf, Frances Greven, Danique Huijbens, Robert Jan Hassing, R.C. Pon, Lieke Preijers, J.H. van Leusen, Harald Verheij, Wim Boersma, Evelien Brans, Paul Kloeg, Kitty Molenaar-Groot, Nhat Khanh Nguyen, Nienke Paternotte, Anke Rol, Lida Stooper, Helga Dijkstra, Esther Eggenhuizen, Lucas Huijs, Simone Moorlag, Mihai Netea, Eva Pranger, Esther Taks, Jaap ten Oever, Rob ter Heine, Kitty Blauwendraat, Bob Meek, Isil Erkaya, Houda Harbech, Nienke Roescher, Rifka Peeters, Menno te Riele, Carmen Zhou, Esther Calbo, Cristina Badia Marti, Emma Triviño Palomares, Tomás Perez Porcuna, Anabel Barriocanal, Ana Maria Barriocanal, Irma Casas, Jose Dominguez, Maria Esteve, Alicia Lacoma, Irene Latorre, Gemma Molina, Barbara Molina, Antoni Rosell, Sandra Vidal, Lydia Barrera, Natalia Bustos, Ines Portillo Calderón, David Gutierrez Campos, Jose Manuel Carretero, Angel Dominguez Castellano, Renato Compagnone, Encarnacion Ramirez de Arellano, Almudena de la Serna, Maria Dolores del Toro Lopez, Marie-Alix Clement Espindola, Ana Belen Martin Gutierrez, Alvaro Pascual Hernandez, Virginia Palomo Jiménez, Elisa Moreno, Nicolas Navarrete, Teresa Rodriguez Paño, Jesús Rodríguez-Baño, Enriqueta Tristán, Maria Jose Rios Villegas, Atsegiñe Canga Garces, Erika Castro Amo, Raquel Coya Guerrero, Josune Goikoetxea, Leticia Jorge, Cristina Perez, María Carmen Fariñas Álvarez, Manuel Gutierrez Cuadra, Francisco Arnaiz de las Revillas Almajano, Pilar Bohedo Garcia, Teresa Giménez Poderos, Claudia González Rico, Blanca Sanchez, Olga Valero, Noelia Vega, Anna Barnes, Helen Catterick, Tim Cranston, Phoebe Dawe, Emily Fletcher, Liam Fouracre, Alison Gifford, John Kirkwood, Christopher Martin, Amy McAnew, Marcus Mitchell, Georgina Newman, Abby O'Connell, Jakob Onysk, Lynne Quinn, Shelley Rhodes, Samuel Stone, Lorrie Symons, Harry Tripp, Darcy Watkins, Bethany Whale, Alex Harding, Gemma Lockhart, Kate Sidaway-Lee, Sam Hilton, Sarah Manton, Daniel Webber-Rookes, Rachel Winder, James Moore, Freya Bateman, Michael Gibbons, Bridget Knight, Julie Moss, Sarah Statton, Josephine Studham, Lydia Hall, Will Moyle, and Tamsin Venton
Subjects: Herpes simplex virus, Cold sore, Herpes labialis, Bacille Calmette-Guérin, Mycobacterium bovis, Prevention, Medicine (General), R5-920
Abstract: Summary: Background: Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects. Methods: In this nested randomised controlled trial within the multicentre, phase 3 BRACE trial, 6828 healthcare workers were randomised in 36 sites in Australia, the Netherlands, Spain, the United Kingdom and Brazil, to receive BCG-Denmark or no BCG (1:1 ratio using a web-based procedure) and followed for 12 months with 3-monthly questionnaires. Exclusion criteria included contraindication to BCG vaccine or previous vaccination with BCG within the past year, any other live-attenuated vaccine within the last month, or any COVID-specific vaccine. The intervention group received one intradermal dose of 0.1 mL of BCG-Denmark corresponding to 2−8 x 105 colony forming units of Mycobacterium bovis, Danish strain 1331. The primary outcome was the difference in restricted mean survival time (i.e., time to first cold-sore recurrence), in participants with frequent recurrent herpes labialis (≥4 recurrences/year), analysed by intention-to-treat. Secondary outcomes addressed additional questions, including analyses in other sub-populations. Adverse events were monitored closely during the first 3 months and were reported in all participants who received one dose of study drug according to intervention received. The BRACE trial is registered with ClinicalTrials.gov, NCT04327206. Findings: Between March 30, 2020 and February 18, 2021, 84 individuals with frequent recurrent cold sores were randomly assigned to BCG (n = 38) or control (n = 46). The average time to first cold-sore recurrence was 1.55 months longer in the BCG group (95% CI 0.27–2.82, p = 0.02) than the control group (hazard ratio 0.54, 95% CI 0.32–0.91; intention-to-treat). The beneficial effect of BCG was greater in the as-treated population (difference 1.91 months, 95% CI 0.69–3.12, p = 0.003; hazard ratio 0.45, 95% CI 0.26–0.76). In prespecified subgroup analyses, only sex modified the treatment effect (interaction p = 0.007), with benefit restricted to males. Over 12 months, a greater proportion of participants in the BCG group compared with the control group reported a decrease in duration (61% vs 21%), severity (74% vs 21%), frequency (55% vs 21%), and impact on quality of life (42% vs 15%) of cold sore recurrences. In participants who had ever had a cold sore, there was also a decrease in self-reported burden of recurrences in the BCG group. In participants who had never had a cold sore, there was an increased risk of a first episode in the BCG group (risk difference 1.4%; 95% CI 0.3–2.6%, p = 0.02). There were no safety concerns. Interpretation: BCG-Denmark vaccination had a beneficial effect on herpes labialis, particularly in males with frequent recurrences, but may increase the risk of a first cold sore. Funding: Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare, and individual donors.
Published: 2023
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26. Early preclinical screening using zebrafish (Danio rerio) reveals the safety of the candidate anti-inflammatory therapeutic agent TnP

Author: João Batista-Filho, Maria Alice Pimentel Falcão, Adolfo Luis Almeida Maleski, Amanda Beatriz Silva Soares, Leticia Balan-Lima, Geonildo Rodrigo Disner, Carla Lima, and Monica Lopes-Ferreira
Subjects: TnP peptide, Preclinical analysis, Toxicology assessments, Zebrafish, Drug safety, Toxicology. Poisons, RA1190-1270
Abstract: The patented anti-inflammatory peptide TnP had its effectiveness recently confirmed in vivo in a murine model of multiple sclerosis and asthma. In this work, the safety of the TnP was evaluated in investigative toxicology tests using zebrafish (Danio rerio) as a model. We conducted the OECD #236 test to investigate effects of the TnP on the survival, hatching performance, and morphological formation of zebrafish embryos. After determining these endpoints, morphometric analysis termination of locomotion eartbeat rate in zebrafish larvae were evaluated to identify adverse effects such as neurotoxicity and cardiotoxicity. The results highlight a wide therapeutic index for TnP with non-lethal and safe doses rom 1 nM to 10 μM, without causing neurotoxicity or cardiotoxic effect. The low frequencyf abnormalities by TnP was associated with high safety of the molecule and the developing embryo's ability to process and eliminate it. TnP crossed the blood-brain barrier without disturbing the normal architecture of forebrain, midbrain and hindbrain. Our data reinforce the importance of zebrafish as an accurate investigative toxicology model to assess acute toxicity as well as cardiotoxicity and neurotoxicity of molecules in the preclinical phase of development.
Published: 2021
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27. IMPACTO DO COVID‐19 E A COINFECÇÃO TB/HIV EM UM CENTRO DE REFERÊNCIA DO SUDESTE BRASILEIRO

Author: Dirce Ines Silva, Sarah Beatriz Silva, and Vanessa Caroline R Magalhaes
Subjects: Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Published: 2021
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28. Effect of thermo-mechanical cycling and chlorhexidine on the bond strength of universal adhesive system to dentin

Author: Rocio Geng Vivanco, Renata Silva Cardoso, Ana Beatriz Silva Sousa, Michelle Alexandra Chinelatti, Sergio Augusto de Freitas Vincenti, Rafaella Tonani-Torrieri, and Fernanda de Carvalho Panzeri Pires-de-Souza
Subjects: Material science, Thermo-mechanical cycling, Bond strength, Chlorhexidine, Universal adhesive systems, Dentin bonding durability, Science (General), Q1-390, Social sciences (General), H1-99
Abstract: Objectives: This study evaluated the influence of thermo-mechanical cycling (TMC) on the bond strength (BS) of a universal adhesive system (UAS - Adper Single Bond Universal, 3M ESPE) to dentin treated or not with 0.2% chlorhexidine (CHX). Methods: Eighty human molars were flattened until reach the dentin and separated into 4 groups according to the bonding protocol: ENR Group: 37% phosphoric acid + 3-step etch-and-rinse adhesive system (ENR); UAS Group: UAS in self-etch mode; ENR + CHX Group: 37% phosphoric acid + CHX + ENR; UAS + CHX Group: CHX + UAS in self-etch mode. After treatments, teeth were restored (Filtek Z350, 3M ESPE). Samples (n = 10) were submitted to aging process: stored in distilled water at 37°C/30 days or TMC (ERIOS - 98N/1.6Hz + thermal cycling 5/37/55 °C - 1,200,000 cycles). Specimens were sectioned into sticks (1.0 mm2) and submitted to the microtensile test (Mechanical Test Machine - 0.5 mm/min). Fracture patterns and hybrid layer integrity were analyzed under Stereomicroscope and Scanning Electron Microscopy (SEM). Results: The BS results (3-way ANOVA, Bonferroni's test, α = 5%) showed that groups treated with CHX presented higher BS values than control groups; significant in all cases (p < .05), except for ENR submitted to TMC (p > .05). When CHX was applied and samples were cycled, UAS revealed higher BS (p < .05) than ENR. After TMC, cohesive fractures increased for UAS, regardless of CHX application. SEM analysis demonstrated different hybridization patterns for the adhesive systems tested. Conclusion: The performance of the universal adhesive system used in self-etch mode was better than that of the 3-step etch-and-rinse adhesive system. Clinical significance: Universal adhesive systems have been developed in order to simplify the dentin hybridization protocol. It is important to determine the longevity of the adhesive interface using these bonding materials after chewing.
Published: 2020
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29. Thiazolyl-isatin derivatives: Synthesis, in silico studies, in vitro biological profile against breast cancer cells, mRNA expression, P-gp modulation, and interactions of Akt2 and VIM proteins.

Author: Freitas LAB, Sousa C, Lima BS, Duarte D, Gomes PATM, Ramos CGC, Costa VCM, Pitta MGDR, Rêgo MJBM, de Simone CA, Videira M, and Leite ACL
Subjects: Humans, Cell Line, Tumor, Female, ATP Binding Cassette Transporter, Subfamily B, Member 1 metabolism, ATP Binding Cassette Transporter, Subfamily B, Member 1 genetics, Molecular Docking Simulation, MCF-7 Cells, Drug Screening Assays, Antitumor, Structure-Activity Relationship, Proto-Oncogene Proteins c-akt metabolism, Breast Neoplasms metabolism, Breast Neoplasms pathology, Breast Neoplasms drug therapy, Isatin pharmacology, Isatin chemistry, Isatin chemical synthesis, RNA, Messenger metabolism, RNA, Messenger genetics, Thiazoles pharmacology, Thiazoles chemistry, Antineoplastic Agents pharmacology, Antineoplastic Agents chemical synthesis, Antineoplastic Agents chemistry
Abstract: The literature reports that thiazole and isatin nuclei present a range of biological activities, with an emphasis on anticancer activity. Therefore, our proposal was to make a series of compounds using the molecular hybridization strategy, which has been used by our research group, producing hybrid molecules containing the thiazole and isatin nuclei. After structural planning and synthesis, the compounds were characterized and evaluated in vitro against breast cancer cell lines (T-47D, MCF-7 and MDA-MB-231) and against normal cells (PBMC). The activity profile on membrane proteins involved in chemoresistance and tumorigenic signaling proteins was also evaluated. Among the compounds tested, the compounds 4c and 4a stood out with IC 50 values of 1.23 and 1.39 μM, respectively, against the MDA-MB-231 cell line. Both compounds exhibited IC 50 values of 0.45 μM for the MCF-7 cell line. Compounds 4a and 4c significantly decreased P-gp mRNA expression levels in MCF-7, 4 and 2 folds respectively. Regarding the impact on tumorigenic signaling proteins, compound 4a inhibited Akt2 in MDA-MB-231 and compound 4c inhibited the mRNA expression of VIM in MCF-7., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
Published: 2024
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30. Effect of natural primer associated to bioactive glass-ceramic on adhesive/dentin interface.

Author: Geng Vivanco R, Tonani-Torrieri R, Souza ABS, Marquele-Oliveira F, and Pires-de-Souza FCP
Subjects: Ceramics, Composite Resins, Dental Cements, Dentin, Dentin-Bonding Agents, Humans, Materials Testing, Resin Cements, Tensile Strength, Dental Bonding
Abstract: Objectives: This study evaluated the effect of propolis associated with Biosilicate on the bond strength (BS) and gelatinolytic activity at the adhesive/dentin interface., Methods: Occlusal cavities were prepared in 320 human molars. Half of them were submitted to cariogenic challenge. All the teeth were separated into eight groups (n = 20): Control - Adhesive System (Single Bond Universal, 3 MESPE); CHX - 0.12 % Chlorhexidine; Bio - 10 % Biosilicate; P16 - Propolis with low levels of polyphenols; P45 - Propolis with high levels of polyphenols; CHX Bio - CHX + Bio; P16 Bio - P16+Bio; P45 Bio - P45+Bio. The adhesive was applied (self-etch mode) after treatments. Restorations (Filtek Z350, 3 MESPE) were performed and samples sectioned into sticks, separated and stored in distilled water at 37 °C for 24 h, 6 months and 1 year. Microtensile BS (0.5 mm/min) was tested and analyzed (2-way ANOVA, Bonferroni's Test, p < .05 and Weibull analysis). Fracture patterns (VH-M100, Keyence) and adhesive interfaces (SEM, EVO-MA10, ZEISS and TEM, JEM-1010, JEOL) were observed; and biodegradation and in situ zymography performed., Results: P16 presented the highest BS values on sound dentin after 6 months. In caries-affected dentin (CAD), the association of treatments promoted the highest BS after 24 h. Sound dentin obtained significantly higher Weibull modulus than CAD. SEM displayed resin tags in P16, P45 and association of treatments. TEM showed good interaction between adhesive and dentin. According to the in situ zymography and biodegradation assay all natural primers reduced the gelatinolytic activity. P45 presented the lowest biodegradation and enzymatic activity., Conclusions: Propolis and the association of treatments promoted the highest bond strength results and preserved the dentin. All the experimental groups exhibited low gelatinolytic activity., Clinical Significance: Propolis and the association of treatments with Biosilicate could preserve the dentin substrate and improve the longevity of composite restorations., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
Published: 2021
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31. An evaluation framework for new approach methodologies (NAMs) for human health safety assessment.

Author: Parish ST, Aschner M, Casey W, Corvaro M, Embry MR, Fitzpatrick S, Kidd D, Kleinstreuer NC, Lima BS, Settivari RS, Wolf DC, Yamazaki D, and Boobis A
Subjects: Humans, Risk Assessment, Toxicity Tests, Decision Making, Safety Management
Abstract: The need to develop new tools and increase capacity to test pharmaceuticals and other chemicals for potential adverse impacts on human health and the environment is an active area of development. Much of this activity was sparked by two reports from the US National Research Council (NRC) of the National Academies of Sciences, Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) and Science and Decisions: Advancing Risk Assessment (2009), both of which advocated for "science-informed decision-making" in the field of human health risk assessment. The response to these challenges for a "paradigm shift" toward using new approach methodologies (NAMS) for safety assessment has resulted in an explosion of initiatives by numerous organizations, but, for the most part, these have been carried out independently and are not coordinated in any meaningful way. To help remedy this situation, a framework that presents a consistent set of criteria, universal across initiatives, to evaluate a NAM's fit-for-purpose was developed by a multi-stakeholder group of industry, academic, and regulatory experts. The goal of this framework is to support greater consistency across existing and future initiatives by providing a structure to collect relevant information to build confidence that will accelerate, facilitate and encourage development of new NAMs that can ultimately be used within the appropriate regulatory contexts. In addition, this framework provides a systematic approach to evaluate the currently-available NAMs and determine their suitability for potential regulatory application. This 3-step evaluation framework along with the demonstrated application with case studies, will help build confidence in the scientific understanding of these methods and their value for chemical assessment and regulatory decision-making., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2020
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32. Cutting frequency effect on barium phytoextraction by macrophytes in flooded environment: A field trial.

Author: Viana DG, Pires FR, Egreja Filho FB, Bonomo R, Martins LF, Costa KA, Ferreira AD, Madalão JC, Rocha Junior PRD, Nascimento MCP, Cruz LBS, and Dias OS
Subjects: Adsorption, Agriculture, Brazil epidemiology, Ecosystem, Eleocharis growth & development, Floods, Hydrogen-Ion Concentration, Soil, Time Factors, Typhaceae growth & development, Barium isolation & purification, Biodegradation, Environmental, Biomass, Soil Pollutants analysis
Abstract: In anoxic environmental conditions and with a drastic reduction of the redox potential, the barium sulphate used in petroleum drilling fluids becomes a hazard to the ecosystem. A field study was conducted in Brazil in an area with a history of accidental Barium (Ba) contamination to evaluate the role of frequent plant cutting on phytoremediation. The plant species Typha domingensis and Eleocharis acutangula, cultivated in a combined plantation, were subjected to four different cut frequencies: every 90 days (four cuts), 120 days (three cuts), 180 days (two cuts), or 360 days (one cut). The total amount of Ba extracted from the soil by the plants was evaluated for each treatment and at different soil depths Overall, total Ba in the soil decreased the most dramatically for cut frequencies of 120 (37.83%) and 180 (47.73%) days at 0-0.2 m below the surface, and with cut frequencies of 120 (51.98%) and 360 (31.79%) at 0.2-0.4 m depth. Further, total Ba in the plant biomass was greatest in the 120 and 360-days frequency groups. Thus, cuts at intervals of 120 days or more are associated with high levels of Ba in the plant tissue and a decrease of soil Ba., (Copyright © 2018 Elsevier B.V. All rights reserved.)
Published: 2019
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33. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

Author: Sewell F, Chapman K, Baldrick P, Brewster D, Broadmeadow A, Brown P, Burns-Naas LA, Clarke J, Constan A, Couch J, Czupalla O, Danks A, DeGeorge J, de Haan L, Hettinger K, Hill M, Festag M, Jacobs A, Jacobson-Kram D, Kopytek S, Lorenz H, Moesgaard SG, Moore E, Pasanen M, Perry R, Ragan I, Robinson S, Schmitt PM, Short B, Lima BS, Smith D, Sparrow S, van Bekkum Y, and Jones D
Subjects: Animals, Humans, International Cooperation, Research Design, Surveys and Questionnaires, Time Factors, Drug Design, Drug Evaluation, Preclinical methods, Models, Animal, Toxicology methods
Abstract: An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations, academic institutions and regulatory bodies) has shared data on the use of recovery animals in the assessment of pharmaceutical safety for early development. These data have been used as an evidence-base to make recommendations on the inclusion of recovery animals in toxicology studies to achieve scientific objectives, while reducing animal use. Recovery animals are used in pharmaceutical development to provide information on the potential for a toxic effect to translate into long-term human risk. They are included on toxicology studies to assess whether effects observed during dosing persist or reverse once treatment ends. The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2014
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33 results on '"Beatriz Silva"'

1. Mycobacterium leprae and Mycobacterium lepromatosis in small mammals in Midwest Brazil

2. Acute toxicity of trypsin inhibitor from tamarind seeds in embryo and adult zebrafish (Danio rerio)

3. PERFIL EPIDEMIOLÓGICO DE HANTAVIROSE ENTRE 2012 E 2022, NO BRASIL

4. PERFIL EPIDEMIOLÓGICO DA TUBERCULOSE GENITURINÁRIO NO BRASIL, ENTRE 2004 E 2023

5. Development of deep learning segmentation models for coronary X-ray angiography: Quality assessment by a new global segmentation score and comparison with human performance

6. Clinical experience of a cardio-oncology consultation at a tertiary university hospital in Portugal: An observational study

7. Toxicology and Biodistribution: The Clinical Value of Animal Biodistribution Studies

8. Contributors

9. Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals

10. Contributors

11. Effect of thermo-mechanical cycling and chlorhexidine on the bond strength of universal adhesive system to dentin

12. Formability limits in sheet-bulk forming

13. On the manufacturing of highly-customized near net-shape medical implants using magnesium alloy sheet

14. Hole-flanging by single point incremental forming

15. Flexible roll forming

16. Recent Approaches for the Determination of Forming Limits by Necking and Fracture in Sheet Metal Forming

17. Contributors

18. Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals

19. Novel experimental techniques for the determination of the forming limits at necking and fracture

20. Insights on the safety of carotenogenic Chlorella vulgaris in rodents

21. About the contributors

22. Single-point incremental forming of polymers

23. Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trialResearch in context

24. Specific and off-target immune responses following COVID-19 vaccination with ChAdOx1-S and BNT162b2 vaccines—an exploratory sub-study of the BRACE trialResearch in context

25. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context

26. Early preclinical screening using zebrafish (Danio rerio) reveals the safety of the candidate anti-inflammatory therapeutic agent TnP

27. IMPACTO DO COVID‐19 E A COINFECÇÃO TB/HIV EM UM CENTRO DE REFERÊNCIA DO SUDESTE BRASILEIRO

28. Effect of thermo-mechanical cycling and chlorhexidine on the bond strength of universal adhesive system to dentin

29. Thiazolyl-isatin derivatives: Synthesis, in silico studies, in vitro biological profile against breast cancer cells, mRNA expression, P-gp modulation, and interactions of Akt2 and VIM proteins.

30. Effect of natural primer associated to bioactive glass-ceramic on adhesive/dentin interface.

31. An evaluation framework for new approach methodologies (NAMs) for human health safety assessment.

32. Cutting frequency effect on barium phytoextraction by macrophytes in flooded environment: A field trial.

33. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

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33 results on '"Beatriz Silva"'

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