Response of estuarine meiofauna assemblage to effects of fertilizer enrichment used in the sugar cane monoculture. Pernambuco, Brazil

A aplicação in situ de fertilizantes inorgânicos foi utilizada para simular a eutrofização associada ao cultivo da cana-de-açúcar. A estrutura da associação de meiofauna foi analisada com o objetivo de avaliar este impacto. O experimento de enriquecimento do sedimento foi desenvolvido em nove áreas quadrangulares de 4m² distribuídas de forma aleatória no mediolitoral da área estuarina. Três áreas foram enriquecidas com alta concentração (375 g/m²) de NPK (Nitrogênio-Fósforo-Potássio), três com baixa concentração (187,5 g/m²) e as demais tratadas como controle. Os fertilizantes foram aplicados semanalmente. Os parâmetros físico-químicos do sedimento e a meiofauna bentônica foram coletados após três a quatro semanas da aplicação dos fertilizantes. Obedecendo este intervalo foram realizadas 6 amostragens subseqüentes. As amostras foram triadas e a meiofauna contada e identificada em nível de grande grupo. As respostas da meiofauna variaram de acordo com a área: enquanto a área Controle manteve sua abundância total durante todo o experimento, as áreas tratadas apresentaram forte queda nas densidades totais. A ordenação MDS e a análise ANOSIM evidenciaram mudanças significativas na estrutura da associação de meiofauna entre as áreas e também ao longo do experimento nas áreas tratadas.In situ application of inorganic fertilizer was used to simulate environmental eutrophication associated with the sugar cane monoculture. Meiofauna community structure is herein used to assess this experimental impact. Nine quadrangular areas (4m² each) were randomly defined in the midlittoral estuarine area. Three of these areas received a high dose of sugar cane fertilizer (375 g/m² Nitrogen-Phosphorus-Potassium), three areas received a low dose of the fertilizer (187.5 g/m²) and the other three areas represented the control. The fertilizer was applied every week. Environmental parameters and meiofauna were sampled using three-to-four week intervals. Six samplings were subsequently performed maintaining this interval. Meiofauna was counted and identified to major taxonomic groups. Meiofauna community structure varied throughout the experimental areas. Control areas maintained their abundance values during the study period, but within the enriched areas meiofauna abundance decreased greatly. MDS and ANOSIM analysis showed significant variation in the meiofauna community structure among experimental areas and also along the experimental period in the enriched areas

Apathy and functional disability in behavioral variant frontotemporal dementia

Background Behavioral variant frontotemporal dementia (bvFTD) has profound consequences on patients and their families. In this multicenter study, we investigated the contribution of cognitive and neuropsychiatric factors to everyday function at different levels of overall functional impairment. Methods In a retrospective cross-sectional study, 109 patients with bvFTD from 4 specialist frontotemporal dementia centers (Australia, England, India, and Brazil) were included. The measures administered evaluated everyday function (Disability Assessment for Dementia [DAD]), dementia staging (Clinical Dementia Rating [CDR]), general cognition (Addenbrooke’s Cognitive Examination–revised [ACE-R]), and neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI]). Patients were then subdivided according to functional impairment on the DAD into mild, moderate, severe, and very severe subgroups. Three separate multiple linear regression analyses were run, where (1) total DAD, (2) basic activities of daily living (BADL), and (3) instrumental activities of daily living (IADL) scores were dependent variables; ACE-R total score and selected NPI domains (agitation/aggression, euphoria, apathy, disinhibition, irritability, aberrant motor behavior) were used as independent variables. Age, sex, education, and country of origin were controlled for in the analyses. Results Cognitive deficits were similar across the mild, moderate, and severe subgroups but significantly worse in the very severe subgroup. NPI domain scores (agitation/aggression, euphoria, apathy, disinhibition, irritability, aberrant motor behavior) did not differ across the DAD subgroups. In the multiple regression analyses, a model including ACE-R and NPI apathy explained 32.5% of the variance for total DAD scores. For IADL, 35.6% of the variance was explained by the ACE-R only. No model emerged for BADL scores. Conclusions Cognitive deficits and apathy are key contributors to functional disability in bvFTD but factors underlying impairment in BADLs remain unclear. Treatments targeting reduction of disability need to address apathy and cognitive impairment to ensure greater efficacy, especially in regards to IADLs

Isokinetic evaluation of knee muscles in soccer players: discriminant analysis [Avaliação isocinética dos músculos do joelho em jogadores de futebol: análise discriminante]; [Evaluación isocinética de los músculos de la rodilla en jugadores de fútbol: análisis discriminante]

Introduction: Muscle activity in soccer players can be measured by isokinetic dynamometer, which is a reliable tool for assessing human performance. Objectives: To perform isokinetic analyses and to determine which variables differentiate the under-17 (U17) soccer category from the professional (PRO). Methods: Thirty four players were assessed (n=17 for each category). The isokinetic variables used for the knee extension-flexion analysis were: peak torque (Nm), total work (J), average power (W), angle of peak torque (deg.), agonist/ antagonist ratio (%), measured for three velocities (60°/s, 120°/s and 300°/s), with each series containing five repetitions. Three Wilks' Lambda discriminant analyses were performed, to identify which variables were more significant for the definition of each of the categories. Results: The discriminative variables at 60°/s in the PRO category were: extension peak torque, flexion total work, extension average power and agonist/antagonist ratio; and for the U17s were: extension total work, flexion peak torque and flexion average power. At 120°/s for the PRO category the discriminant variables were: flexion peak torque and extension average power; for the U17s they were: extension total work and flexion average power. Finally at 300°/s, the variables found in the PRO and U17 categories respectively were: extension average power and extension total work. Conclusion: Isokinetic variables for flexion and extension knee muscles were able to significantly discriminate between PRO and U17 soccer players. RESUMO Introdução: A atividade muscular em jogadores de futebol pode ser medida por meio do dinamômetro isocinético, que é um instrumento confiável para avaliação do desempenho humano. Objetivos: Conduzir análises isocinéticas e discriminar quais variáveis diferenciam a categoria sub-17 (S17) da profissional (PRO). Métodos: Trinta e quatro jogadores de futebol (n=17 para cada categoria) foram avaliados. As variáveis isocinéticas utilizadas para a análise de extensão-flexão do joelho foram: pico de torque (Nm), trabalho total (J), potência média (W), ângulo de pico de torque (graus), razão agonista/antagonista (%), testadas em três velocidades (60°/s, 120°/s e 300°/s), com cada série contendo cinco repetições. Três análises discriminantes foram feitas usando o método Wilk's Lambda para identificar quais variáveis fariam uma discriminação significativa entre as duas categorias. Resultados: As variáveis discriminantes a 60°/s na categoria PRO foram: pico de torque extensores, trabalho total flexores, potência média de extensores e razão agonista/antagonista; e para os S17 foram: trabalho total de extensores, pico de torque de flexores e potência média de flexores. A 120°/s para a categoria PRO as variáveis discriminantes foram: pico de torque de flexores e potência média de extensores; para os S17 foram: trabalho total de extensores e potência média de flexores. A 300°/s, as variáveis encontradas para as categorias PRO e S17 foram, respectivamente: potência média de extensores e trabalho total de extensores. Conclusão: As variáveis isocinéticas para os músculos do joelho flexores e extensores foram capazes de fazer uma discriminação significativa entre jogadores de futebol PRO e S17. RESUMEN Introducción: La actividad muscular en jugadores de fútbol puede ser medida por medio del dinamómetro isocinético, que es un instrumento confiable para evaluación del desempeño humano. Objetivos: Conducir análisis isocinéticos y discriminar qué variables diferencian la categoría sub-17 (S17) de la profesional (PRO). Métodos: Fueron evaluados treinta y cuatro jugadores de fútbol (n=17 para cada categoría). Las variables isocinéticas utilizadas para el análisis de extensión-flexión de la rodilla fueron: pico de torque (Nm), trabajo total (J), potencia media (W), ángulo de pico de torque (grados), razón agonista/antagonista (%), probadas en tres velocidades (60°/s, 120°/s y 300°/s), con cada serie conteniendo cinco repeticiones. Fueron realizados tres análisis discriminantes usando el método Wilk's Lambda para identificar qué variables harían una discriminación significativa entre las dos categorías. Resultados: Las variables discriminantes a 60°/s en la categoría PRO fueron: pico de torque extensores, trabajo total flexores, potencia media de extensores y razón agonista/antagonista; y para los S17 fueron: trabajo total de extensores, pico de torque de flexores y potencia media de flexores. A 120°/s para la categoría PRO las variables discriminantes fueron: pico de torque de flexores y potencia media de extensores; para los S17 fueron: trabajo total de extensores y potencia media de flexores. A 300°/s, las variables encontradas para las categorías PRO y S17 fueron, respectivamente: potencia media de extensores y trabajo total de extensores. Conclusión: Las variables isocinéticas para los músculos de la rodilla flexores y extensores fueron capaces de hacer una discriminación significativa entre jugadores de fútbol PRO y S17

Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study

Background: Myocardial infarction remains as a major cause of mortality worldwide and a high rate of survivors develop heart failure as a sequel, resulting in a high morbidity and elevated expenditures for health system resources. We have designed a multicenter trial to test for the efficacy of autologous bone marrow (ABM) mononuclear cell (MC) transplantation in this subgroup of patients. The main hypothesis to be tested is that treated patients will have a significantly higher ejection fraction (EF) improvement after 6 months than controls. Methods: A sample of 300 patients admitted with ST elevation acute myocardial infarction (STEMI) and left ventricle (LV) systolic dysfunction, and submitted to successful mechanical or chemical recanalization of the infarct-related coronary artery will be selected for inclusion and randomized to either treated or control group in a double blind manner. The former group will receive 100 x 106 MC suspended in saline with 5% autologous serum in the culprit vessel, while the latter will receive placebo (saline with 5% autologous serum). Implications: Many phase I/II clinical trials using cell therapy for STEMI have been reported, demonstrating that cell transplantation is safe and may lead to better preserved LV function. Patients with high risk to develop systolic dysfunction have the potential to benefit more. Larger randomized, double blind and controlled trials to test for the efficacy of cell therapies in patients with high risk for developing heart failure are required.Brazilian Ministry of Science and Technology (MCT)/The Financing Agency for Studies and Projects (FINEP

Artificial intelligence and real-world data for drug and food safety - A regulatory science perspective

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications through the annual conference Global Summit on Regulatory Science (GSRS). The 11th annual GSRS conference (GSRS21) focused on "Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI)." The conference discussed current advancements in both AI and RWD approaches with a specific emphasis on how they impact regulatory sciences and how regulatory agencies across the globe are pursuing the adaptation and oversight of these technologies. There were presentations from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the United Kingdom, and the United States. These presentations highlighted how various agencies are moving forward with these technologies by either improving the agencies' operation and/or preparing regulatory mechanisms to approve the products containing these innovations. To increase the content and discussion, the GSRS21 hosted two debate sessions on the question of "Is Regulatory Science Ready for AI?" and a workshop to showcase the analytical data tools that global regulatory agencies have been using and/or plan to apply to regulatory science. Several key topics were highlighted and discussed during the conference, such as the capabilities of AI and RWD to assist regulatory science policies for drug and food safety, the readiness of AI and data science to provide solutions for regulatory science. Discussions highlighted the need for a constant effort to evaluate emerging technologies for fit-for-purpose regulatory applications. The annual GSRS conferences offer a unique platform to facilitate discussion and collaboration across regulatory agencies, modernizing regulatory approaches, and harmonizing efforts