International migration, food insecurity, and mental health: A scoping review protocol / Migración internacional, inseguridad alimentaria y salud mental: protocolo de una revisión de alcance

Introducción La inseguridad alimentaria es una prioridad mundial que, según se ha constatado, repercute negativamente en la salud mental, aumentando los riesgos de padecer trastornos mentales comunes y enfermedades mentales graves. Los migrantes internacionales pueden enfrentarse a la inseguridad alimentaria a lo largo del ciclo migratorio, debido a una serie de factores de riesgo como las precarias condiciones de tránsito, la precariedad laboral, la presión financiera, la discriminación y la falta de disponibilidad y acceso a alimentos culturalmente relevantes, entre otros. Aunque existen varias revisiones sobre migración, inseguridad alimentaria y salud en general, no se ha realizado ninguna revisión de alcance sobre la inseguridad alimentaria entre los migrantes internacionales con especial atención a la salud mental. Objetivo Investigar la evidencia sobre inseguridad alimentaria y salud mental entre los migrantes internacionales. Métodos Se realizará una búsqueda de literatura científica en inglés, español, francés, italiano y portugués publicada desde 2013 en las bases de datos Web of Science, PubMed, Medline, APA PsycArticles, Cinahl, y ASSIA, y de literatura gris en Google Scholar. Dos autores revisarán de forma independiente los títulos, resúmenes y textos completos, antes de extraer los datos de las publicaciones que cumplan los criterios de elegibilidad. Los datos extraídos se mapearán descriptivamente según categorías temáticas generales emergentes. Resultados esperados La revisión contribuirá a identificar lo que se sabe sobre la migración internacional, la inseguridad alimentaria y la salud mental, las lagunas en la literatura sobre el tema, las oportunidades para subtemas específicos de investigación, y explorar cómo la inseguridad alimentaria y la salud mental pueden estar vinculadas en la literatura existente.

Introduction Food insecurity is a global priority that has been found to negatively impact mental health, increasing the risk of mental disorders and severe mental illness. International migrants may face food insecurity throughout their migratory cycle due to a range of risk factors, such as poor transit conditions, precarious employment, financial pressure, discrimination, and lack of availability and access to culturally relevant food, among others. Although there are multiple reviews on migration, food insecurity, and health in general, no scoping review has been conducted on food insecurity among international migrants focusing on mental health. Objective To investigate the available evidence on food insecurity and mental health among international migrants. Methods A search of scientific literature in English, Spanish, French, Italian, and Portuguese published since 2013 will be performed in the Web of Science, PubMed, Medline, APA PsycArticles, Cinahl, and ASSIA databases, including grey literature available in Google Scholar. Two authors will independently review titles, abstracts, and full texts before extracting data from publications complying with the eligibility criteria. Extracted data will be descriptively mapped according to emerging thematic categories. Expected results The review will contribute to identifying what is known about international migration, food insecurity, and mental health, gaps in the literature, opportunities for specific research subtopics, and how food insecurity and mental health can be linked in the existing literature.

Incidence of Muscular Strength, Anthropometry, and Asymmetry in the General Index of Autonomy in Older Chilean Women

SUMMARY: Frailty affects the functional autonomy (FA) of older adults and could manifest itself in muscle imbalances in the limbs, resulting in a disparity in size and strength between them. In Chile, information on the relationship between muscle strength (MS) levels and FA asymmetries in older women is limited. This study related the levels of MS, anthropometric parameters, and asymmetries of the lower and upper limbs, with the FA of a group of older Chilean women. The study included 39 women who participated, and their FA was evaluated using the GDLAM index (IG). Based on the score obtained in the IG, they were classified by percentiles as Group 1 with favorable FA (P ≤ 50) and Group 2 with low FA (P > 50). Anthropometric parameters were BMI, fat percentage, bone mass, circumferences (arm, thigh, calf), diameters (humerus, femur) and upper/lower limb strength was evaluated to determine asymmetries. The differences between the covariates of both groups were evaluated using the student's t test and the Mann-Whitney test for independent samples. G1 presented less asymmetry (p > 0.05) in the lower limbs and greater calf circumference than G2 (p < 0.05). G1 presented greater bilateral strength (dominant and non-dominant limb) compared to G2 (p < 0.05). The covariates of age, anthropometry, MS, and lower/upper limb asymmetries influence FA in older women.

La fragilidad afecta la autonomía funcional (AF) de las personas mayores y podría manifestarse en desequilibrios musculares en los miembros, dando lugar a una disparidad de tamaño y fuerza entre ellos. En Chile, la información que relaciona los niveles de fuerza muscular (FM) y las asimetrías con la AF en mujeres mayores es limitada. Este estudio relacionó los niveles de FM, parámetros antropométricos y asimetrías de los miembros inferiores y superiores, con la AF de un grupo de mujeres mayores chilenas. Participaron 39 mujeres, cuya AF se evaluó mediante el índice GDLAM (IG). En función de la puntuación obtenida en el IG, se clasificaron por percentiles en Grupo 1 con AF favorable (P ≤ 50) y Grupo 2 con AF baja (P > 50). Los parámetros antropométricos fueron IMC, porcentaje de grasa, masa ósea, circunferencias (brazo, muslo, pantorrilla), diámetros (húmero, fémur) y se evaluó la fuerza de los miembros superiores/ inferiores para determinar asimetrías. Las diferencias entre las covariables de ambos grupos se evaluaron mediante la prueba t de student y la prueba de Mann-Whitney para muestras independientes. G1 presentó menor asimetría (p > 0,05) en los miembros inferiores y mayor perímetro de pantorrilla que G2 (p < 0,05). G1 presentó mayor fuerza bilateral (miembro dominante y no dominante) en comparación con G2 (p < 0,05). Las covariables de antropometría, FM y asimetrías de extremidades inferiores/superiores influyen en la AF en mujeres mayores.

Acupuncture for generalized anxiety disorder: a study protocol for a randomized controlled trial

During the COVID-19 outbreak, there was a sharp increase in generalized anxiety disorder (GAD). Acupuncture therapy has the advantages of accurate clinical efficacy, safety and reliability, few adverse reactions, and no dependence, and is gradually becoming one of the emerging therapies for treating GAD. We present a study protocol for a randomized clinical trial with the aim of exploring the mechanism of brain plasticity in patients with GAD and evaluate the effectiveness and reliability of acupuncture treatment. Transcranial magnetic stimulation (TMS) will be used to assess cortical excitability in GAD patients and healthy people. Sixty-six GAD patients meeting the inclusion criteria will be randomly divided into two groups: TA group, (treatment with acupuncture and basic western medicine treatment) and SA group (sham acupuncture and basic western medicine treatment). Twenty healthy people will be recruited as the control group (HC). The parameters that will be evaluated are amplitude of motor evoked potentials (MEPs), cortical resting period (CSP), resting motor threshold (RMT), and Hamilton Anxiety Scale (HAMA) score. Secondary results will include blood analysis of γ-aminobutyric acid (GABA), glutamate (Glu), glutamine (Gln), serotonin (5-HT), and brain-derived nerve growth factor (BDNF). Outcomes will be assessed at baseline and after the intervention (week 8). This study protocol is the first clinical trial designed to detect differences in cerebral cortical excitability between healthy subjects and patients with GAD, and the comparison of clinical efficacy and reliability before and after acupuncture intervention is also one of the main contents of the protocol. We hope to find a suitable non-pharmacological alternative treatment for patients with GAD.

Multidisciplinary treatment program for improvement in pain and disability associated with nonspecific chronic low back pain / Programa de tratamento multidisciplinar para melhora da dor e incapacidade associada a dor crônica lombar inespecífica

ABSTRACT BACKGROUND AND OBJECTIVES: Lumbar disorders, which contribute to significant workplace absenteeism and chronic disability, are associated with a considerable financial and social burden. Although a conservative approach provides satisfactory pain relief, biomechanical improvement and is associated with a low risk of adverse effects, there is lack of consensus in the literature regarding the best therapeutic strategy in such cases. METHODS: This retrospective longitudinal study used secondary data from the institutional medical records of patients who completed a multidisciplinary program for the treatment of low back pain between 2019 and 2021. Data regarding pain levels and motor skills were obtained from patients who completed the care program at a private hospital in Bento Gonçalves, RS. The following step-wise treatment algorithm was used: evaluation by a specialist physician for the etiological diagnosis of pain, pharmacological management and dry needling, followed by standard rehabilitation intervention performed by the physiotherapy team and exercises by the physical education team. The visual analogue scale (VAS) was used to measure pain at the start and at the completion of the intervention, and the Oswestry Disability Index (ODI) was used to measure motor skills at the start and at 6 and 12 months following the multiprofessional intervention for rehabilitation. RESULTS: A reduction in pain and motor disability in patients who completed all stages of the treatment program was observed. Pain by the VAS presented the following scores: baseline 7 [5-8] and after treatment 2 [0-4]; and the scores of the ODI were: at baseline 0.34 [0.26 - 0.40], at 6 months 0.16 [0.08 - 0.26] and after treatment 0.12 [0.04 - 0.21]. CONCLUSION: The treatment program reduced the pain and disability associated with low back pain and can serve as the basis for further studies carried out to confirm the effectiveness of this intervention.

RESUMO JUSTIFICATIVA E OBJETIVOS: As doenças lombares, que contribuem para um absenteísmo significativo no local de trabalho e para a incapacidade crônica, estão associadas a um encargo financeiro e social considerável. Embora a abordagem conservadora proporcione alívio satisfatório da dor, melhore a biomecânica e esteja associada a baixo risco de efeitos adversos, não há consenso na literatura sobre a melhor estratégia terapêutica nesses casos. MÉTODOS: Neste estudo longitudinal retrospectivo, foram utilizados dados secundários dos prontuários médicos institucionais de pacientes que completaram um programa multidisciplinar para tratamento de dor lombar entre 2019 e 2021. Dados sobre níveis de dor e habilidades motoras foram obtidos de pacientes que completaram o programa assistencial de um hospital privado de Bento Gonçalves, RS. Foi utilizado o seguinte tratamento passo a passo: avaliação por médico especialista para diagnóstico etiológico da dor, manejo farmacológico e agulhamento a seco, seguido de intervenção de reabilitação padrão realizada pela equipe de fisioterapia e exercícios pela equipe de educação física. A escala analógica visual (EAV) foi utilizada para medir a dor no início e após a conclusão da intervenção, e o Índice de Incapacidade de Oswestry (ODI) foi usado para medir as habilidades motoras no início e aos 6 e 12 meses após a intervenção multiprofissional para reabilitação. RESULTADOS: Observou-se redução na dor e na incapacidade motora em pacientes que completaram todas as etapas do programa de tratamento. A intensidade da dor medida pela EAV apresentou as seguintes pontuações: basal 7 [5-8] e após tratamento 2 [0-4]; enquanto o ODI apresentou as pontuações: basal 0,34 [0,26 - 0,40], até 6 meses 0,16 [0,08 - 0,26] e após o tratamento 0,12 [0,04 - 0,21]. CONCLUSÃO: O programa de tratamento reduziu a dor e a incapacidade associadas à dor lombar e pode servir de base para novos estudos realizados para confirmar a eficácia desta intervenção.

Protocolo de avaliação para apraxia de fala adquirida / Assessment protocol for acquired apraxia of speech

RESUMO Objetivo Elaborar um protocolo de avaliação do planejamento motor da fala com estímulos fonologicamente balanceados para o português brasileiro e que contemple todas as variáveis necessárias para este diagnóstico. Método Foram realizadas três etapas: Na primeira, construíram-se listas de palavras cujo critério principal foram os padrões silábicos e acentuais. Do levantamento realizado na Etapa 1, procedeu-se à seleção dos vocábulos que compuseram a primeira versão do protocolo na Etapa 2, reunidas em duas tarefas: de repetição e de Leitura em Voz Alta (LVA). Em seguida, investigou-se a ocorrência das palavras usando a base de dados do Corpus Brasileiro (PUC-SP) - Linguateca. Na etapa 3 realizou-se a análise estatística para verificar se as listas de repetição e de LVA estavam equilibradas quanto à ocorrência das palavras. Assim, as listas foram distribuídas em quartis e foram analisadas de forma descritiva e bivariada. O nível de significância utilizado foi de 5%. Resultados Após a realização de todas as etapas, foi possível obter as palavras que compuseram as listas das tarefas de repetição e de LVA. Finalmente, foram então acrescidas ao protocolo as demais tarefas consideradas essenciais para a avaliação da apraxia como as taxas diadococinéticas e a prancha para a emissão oral espontânea. Conclusão O protocolo desenvolvido contém as tarefas consideradas padrão para a avaliação da apraxia de fala pela literatura internacional, o que torna esse instrumento importante para o diagnóstico desse distúrbio em falantes do português brasileiro.

ABSTRACT Purpose To develop an assessment protocol for speech motor planning with phonologically balanced stimuli for Brazilian Portuguese, including all necessary variables for this diagnosis. Methods Three stages were carried out: In the first, word lists were built with the main criterion being syllabic and accentual patterns. From the survey conducted in Stage 1, the words that composed the first version of the protocol lists in Stage 2 were selected, and grouped into two fundamental tasks for diagnosing acquired apraxia of speech (AOS): repetition and Reading Aloud (RA). In Stage 3, the occurrence of words was investigated using the Brazilian Corpus (PUC-SP) - Linguateca database, and a statistical analysis was performed to verify if the repetition and RA lists were balanced in terms of the occurrences. Thus, the lists were distributed in quartiles and submitted to both descriptive and bivariate analyses. A significance level of 5% (p<0.05) was adopted. Results After completion of all stages, the words that composed the lists of the repetition and RA tasks were obtained. Finally, other tasks considered essential for the assessment of AOS, such as diadochokinetic rates and the board for spontaneous oral emission, were then added to the protocol. Conclusion The developed protocol contains the tasks considered standard for the assessment of AOS according to the international literature, which makes this instrument important for diagnosing this disorder in speakers of Brazilian Portuguese.

Consensus of the Brazilian association of hematology, hemotherapy and cellular therapy on patient blood management: Management of critical bleeding

Abstract The management of major bleeding is a critical aspect of modern healthcare and it is imperative to emphasize the importance of applying Patient Blood Management (PBM) principles. Although transfusion support remains a vital component of bleeding control, treating severe bleeding goes beyond simply replacing lost blood. A more comprehensive, multidisciplinary approach is essential to optimize patient outcomes and minimize the risks associated with excessive transfusions.

Evaluación de validez convergente y discriminante de un protocolo de cribado online para detección de deterioro cognitivo leve en personas mayores en Chile

Introducción: La detección temprana del deterioro cognitivo en personas mayores permite disminuir la incertidumbre y mejorar las tareas de intervención. El objetivo de esta investigación fue determinar las características psicométricas de un protocolo de cribado online para detectar tempranamente deterioro leve en personas mayores. Método: el método usado fue de tipo mixta con preguntas de tipo cuantitativas y cualitativas. La muestra fue de 75 personas mayores del gran Concepción, región del Bio-Bio. El protocolo estaba compuesto por: Cuestionario sociodemográfico, Test del Reloj Versión Cacho, Moca, Escala Depresión Yesavage y Test Acentuación de Palabras. El procedimiento consistió en la aplicación del protocolo a través de un Tablet o Laptop, videollamadas. Resultados: Se encontró que el protocolo presenta validez discriminante y convergente. Conclusiones: se concluye que el protocolo de cribado online para detectar tempranamente deterioro leve en personas mayores es válido y fiable. Se discute el uso y la aplicación de un protocolo cribado usando la Teleneuropsicología (TeleNP), en personas mayores

ABTRACT Introduction: Early detection of cognitive impairment in the elderly allows us to reduce uncertainty and improve intervention tasks. The objective of this research was to determine the psychometric characteristics of an online screening protocol for early detection of mild impairment in the elderly. Method: the method used was of a mixed type with quantitative and qualitative questions. The sample consisted of 75 older people from the greater Concepción, Bio-Bio region. The protocol consisted of: Sociodemographic Questionnaire, Cacho Version Clock Test, Mocha, Yesavage Depression Scale and Word Stress Test. The procedure consisted of the application of the protocol through a Tablet or Laptop, video calls. Results: It was found that the protocol presents discriminant and convergent validity. Conclusions: it is concluded that the online screening protocol for early detection of mild deterioration in the elderly is valid and reliable. The use and application of a screening protocol using Teleneuropsychology (TeleNP) in older people is discussed.

Protocolo para el tratamiento de la recesión gingival con membrana de fibrina rica en plaquetas

Introducción: Es necesario la aplicación de protocolos de actuación como herramientas que permiten homogeneizar los procedimientos plásticos periodontales regenerativos y establecer las pautas de actuación del Periodontólogo para el abordaje de las recesiones gingivales con esta modalidad terapéutica de avanzada. Objetivo: Diseñar un protocolo para el tratamiento de la recesión gingival mediante la utilización de la membrana de fibrina rica en plaquetas, asociada al colgajo de avance coronal. Métodos: Se realizó una investigación con enfoque cualitativo en la Facultad de Estomatología de Villa Clara, de julio de 2020 a diciembre de 2021. Para el diseño del protocolo se empleó una fase de preparación y una de elaboración; dentro de esta última se estructuraron tres momentos: revisión sistemática de la literatura, aplicación de técnicas grupales (grupo focal y nominal) y conclusión del documento. Se realizó una valoración por criterios de especialistas externos antes de concluir la estructura definitiva del protocolo. Resultados: Se consultaron cinco guías para la confección de protocolos, cinco protocolos de atención médica y enfermería y 10 estomatológicos. La estructura del documento quedó conformada por: portada, introducción, objetivos, profesionales a quienes va dirigido, población diana, proceso de elaboración, procedimiento, algoritmo, fecha de implementación y revisión, proceso de implantación, indicadores de evaluación, glosario y referencias bibliográficas. Conclusiones: Se diseñó un protocolo de actuación que establece las pautas para la realización del proceder terapéutico regenerativo, desde la selección de los pacientes hasta la evolución de la terapéutica. El documento se valoró por especialistas externos como positivo.

Introduction: It is necessary to apply action protocols as tools to homogenize regenerative periodontal plastic procedures and to establish the guidelines for the periodontist to approach gingival recession with this advanced therapeutic modality. Objective: To design a protocol for the treatment of gingival recession using platelet-rich fibrin membrane associated with coronal advancement flap. Methods: A research with a qualitative approach was carried out in the School of Stomatology of Villa Clara, from July 2020 to December 2021. For the design of the protocol, a preparation phase and an elaboration phase were used; within the latter, three moments were structured: systematic review of the literature, application of group techniques (focal and nominal group) and conclusion of the document. An evaluation by external specialists was carried out before finalizing the definitive structure of the protocol. Results: Five guides for the preparation of protocols, five medical and nursing care protocols and 10 stomatological protocols were consulted. The structure of the document consisted of: cover page, introduction, objectives, target professionals, target population, elaboration process, procedure, algorithm, implementation and revision date, implementation process, evaluation indicators, glossary and bibliographic references. Conclusions: An action protocol was designed that establishes the guidelines for carrying out the regenerative therapeutic procedure, from the selection of patients to the evolution of the therapy. The document was positively evaluated by external specialists.

Cases Analysis and Countermeasures Discussion on Ethical Review of Clinical Trial Protocol Violation / 中国医学伦理学

To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.

Impact of Telemedicine use on clinical care indicators of pediatric intensive care units: protocol for a cluster randomized clinical trial / Impacto do uso da Telemedicina nos indicadores clínicos assistenciais de unidades de terapia intensiva pediátricas: protocolo para um ensaio clínico randomizado em cluster

ABSTRACT The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710

RESUMO O objetivo deste estudo será apresentar o protocolo de um ensaio clínico randomizado em cluster a ser realizado por meio do projeto TeleUTI - Qualificação da Assistência em Terapia Intensiva por Telemedicina. O estudo consistirá em um ensaio clínico randomizado por cluster, open label, em unidades de terapia intensiva pediátricas, com proporção de alocação de 1:1, com o intuito de comparar o grupo de intervenção (apoio da telemedicina para os pacientes internados na unidade de terapia intensiva pediátrica) com um grupo controle (cuidados habituais da unidade de terapia intensiva pediátrica). O estudo se propõe a selecionar 16 unidades de terapia intensiva pediátricas, incluindo 100 participantes por local, com o total de 1.600 participantes. O grupo intervenção receberá telerounds de segunda-feira a sexta-feira e terá à disposição especialistas e atividades de educação continuada. O desfecho primário a ser avaliado será o tempo de permanência nas unidades de terapia intensiva pediátricas, definido pela diferença entre a data de alta do participante com a data de admissão na unidade de terapia intensiva. Os desfechos secundários serão: taxa de mortalidade; dias livres de ventilação mecânica, dias de uso de antibióticos, dias de uso de drogas vasoativas e dias de uso de sedoanalgesia. Este estudo será conduzido em conformidade com a resolução 466/12 do Conselho Nacional de Saúde, com aprovação pelo Comitê de Ética em Pesquisa das instituições hospitalares envolvidas. O trabalho tem o potencial de reproduzir estudos sobre Telemedicina em cuidados intensivos, podendo trazer contribuições importantes ao atendimento em unidades de terapia intensiva no Brasil e em outras realidades. Se a Telemedicina mostrar resultados clínicos assistenciais positivos em relação ao tratamento convencional, mais pacientes pediátricos poderão ser beneficiados. Registro ClinicalTrials.gov: NCT05260710

Outcomes of topography-guided PRK/CXL in keratoconus using the NIDEK CXIII system棓Bharat Protocol� (Pilot study)

Purpose: Outcome of topography?guided excimer laser ablation in conjunction with accelerated, high?fluence cross?linking in corneal ecstatic disease using the NIDEK CXIII equipped with CATz algorithm from the FinalFit software棓Bharat Protocol.� Methods: Retrospective case record review of 30 eyes of 17 patients of stage 1?3 keratoconus who underwent the procedure was performed. Data collected were for visual acuity, distortion?induced eye pain, and keratometry. Pachymetry, lower order and higher order aberrations, spherical aberrations, and topographic cylinder were documented from by Scheimpflug imaging (Pentacam 70700: Oculus, Wetzlar, Germany). Results: At a minimum follow?up of 6 months (range 6.2� months), there was significant improvement in UCVA (P < 0.00001), BCVA (P = 0.0061), decrease in Kmax (P = 0.0349), Ksteep (P < 0.0411), Kflat (P = 0.0099), and pachymetry (P = 0.0001). Significant improvement was also seen in distortion?induced eye pain (27/30 to 2/30; P < 0.00001). A more than two?line improvement in UCVA and BCVA was seen in 23/30 and 17/30 cases, respectively. Ectasia was stabilized in all cases at the last follow?up, and no complications were seen. Conclusions: The 揃harat� Protocol to arrest keratectasia progression and improve corneal regularity is a safe and efficacious alternative as a keratoconus management option. This is the first such study on Nidek Platform for the same.

Predictors of Mortality and Functional recovery after severe traumatic brain injury: protocol for a prospective cohort study

Introduction: traumatic brain injury is a global public health problem due to its severity and high rates of morbimortality worldwide. Identifying predictors associated with increased mortality and unfavorable functional outcomes after the traumatic brain injury event is crucial for minimizing morbidity and mortality rates. Therefore, this study aims to establish a protocol to investigate the predictors of mortality and functional recovery after severe traumatic brain injury in Brazil.Methods: The study will include all patients admitted for severe traumatic brain injury (Glasgow Coma Scale ≤ 8) at the State Hospital of Urgency and Emergency, which is the referral trauma hospital of Espirito Santo. The outcomes of interest are hospital mortality and functional recovery 24 months after hospital discharge. Subjects will be followed up at seventy-two hours, three months, six months, twelve months, and twenty-four months after the trauma. Morbidity will be determined by assessing: 1) the level of motor and cognitive disability, 2) functional impairment and quality of life, and 3) aspects of rehabilitation treatment. Additionally, the traumatic brain injury load, estimated by the years of life lost, will be calculated. Discussion: the results of this study will help identify variables that can predict morbidity and mortality, as well as diagnostic and therapeutic targets for patients with severe traumatic brain injury. Furthermore, the findings will have practical implications for: 1) the development of public policies, 2) investments in hospital infrastructure 3) understanding the socioeconomic impact of functional loss in the individuals.Study registration: the study received approval from the Ethics Committee of the Federal University of Espirito Santo under protocol number 4.222.002 on August 18, 2020.

Introdução: traumatismo cranioencefálico é um problema global de saúde pública devido à sua gravidade e altas taxas de morbimortalidade em todo o mundo. Identificar preditores associados ao aumento da mortalidade e desfechos funcionais desfavoráveis após o evento do traumatismo craniencefálico é primordial para minimizar as taxas de morbidade e mortalidade. Portanto, este estudo tem como objetivo estabelecer um protocolo para investigar os preditores de mortalidade e recuperação funcional após traumatismo cranioencefálico grave no Brasil. Métodos: este estudo tem como objetivo investigar os preditores de mortalidade e recuperação funcional em pacientes com traumatismo cranioencefálico, além de fornecer uma visão geral do traumatismo cranioencefálico no estado do Espírito Santo. O estudo abrangerá todos os pacientes internados por traumatismo cranioencefálico grave (Escala de Coma de Glasgow ≤ 8) no Hospital Estadual de Urgência e Emergência, o hospital de referência para traumas no Espírito Santo. Os desfechos de interesse incluem mortalidade hospitalar e recuperação funcional após 24 meses da alta hospitalar. Os participantes serão acompanhados em setenta e duas horas, três meses, seis meses, doze meses e vinte e quatro meses após o trauma. A morbidade será determinada pela avaliação de: 1) nível de incapacidade motora e cognitiva, 2) comprometimento funcional e qualidade de vida, e 3) aspectos do tratamento e reabilitação. Além disso, a carga de traumatismo cranioencefálico, estimada em anos de vida perdidos, será calculada. Discussão: os resultados deste estudo ajudarão a identificar variáveis que podem predizer a morbidade e a mortalidade após traumatismo cranioencefálico grave. Além disso, as descobertas terão implicações práticas para: 1) o desenvolvimento de políticas públicas, 2) investimentos em infraestrutura hospitalar e 3) compreensão do impacto socioeconômico da perda funcional nesses indivíduos. Registro do estudo: o estudo recebeu aprovação do Comitê de Ética da Universidade Federal do Espírito Santo sob o número de protocolo 4.222.002 em 18 de agosto de 2020

Photobiomodulation efficacy of major salivary glands in children with caries activity: study protocol for randomized, double-blind, placebo-controlled, parallel-group clinical trial / Efeito da fotobiomodulação das principais glândulas salivares em crianças com actividade de cárie: ensaio clínico aleatório duplo-cego

Background: Dental caries is one of the most prevalent diseases among children worldwide. Saliva plays a significant role in the demineralization/remineralization of the dental surface. Several salivary characteristics, such as flow rate, pH, and buffering capacity, provide relevant information regarding the development of carious lesions. Photobiomodulation has shown promising results in improving salivary flow rate and buffer capacity in the adult population. Purpose: of this trial was to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries. Methods: This protocol details a randomized, double-blind, parallel-group, controlled trial that evaluated salivary parameters through photobiomodulation in children. Fifty 6- to 12-year-old participants will be randomly divided into two groups:1) photobiomodulation experimental group (G1) (n=25) and 2) photobiomodulation placebo group (G2) (n=25). Infrared light will be applied at 16 intra-and extraoral points and placebo, respectively. Unstimulated salivary samples will be collected before and immediately after application once a week for three consecutive weeks. Salivary samples will be analyzed for their flow rate, pH, and buffering capacity. The primary outcomes are the differences in salivary flow rates between G1 and G2. The secondary outcomes are differences in salivary pH and buffering capacity between G1 and G2. Discussion: The results of this clinical trial will offer evidence for the efficacy of photobiomodulation in salivary parameters and to support decision-making regarding non-invasive treatments to control dental caries.

Contexto: A cárie dentária é uma das doenças mais prevalentes entre as crianças em todo o mundo. A saliva desempenha um papel significativo na desmineralização/remineralização da superfície dentária. Várias características salivares, como a taxa de fluxo, o pH e a capacidade de tamponamento, fornecem informações relevantes sobre o desenvolvimento de lesões de cárie. A fotobiomodulação demonstrou resultados promissores na melhoria da taxa de fluxo salivar e da capacidade de tamponamento na população adulta. Objetivo: deste estudo foi avaliar a eficácia da fotobiomodulação das glândulas salivares principais sobre os parâmetros salivares em crianças com cárie. Métodos: Este protocolo detalha um estudo randomizado, duplo-cego, de grupos paralelos e controlado que avaliou parâmetros salivares por meio da fotobiomodulação em crianças. Cinquenta participantes de 6 a 12 anos de idade serão divididos aleatoriamente em dois grupos: 1) grupo experimental de fotobiomodulação (G1) (n=25) e 2) grupo placebo de fotobiomodulação (G2) (n=25). A luz infravermelha será aplicada em 16 pontos intra e extraorais e o placebo, respectivamente. Amostras salivares não estimuladas serão coletadas antes e imediatamente após a aplicação, uma vez por semana, durante três semanas consecutivas. As amostras salivares serão analisadas quanto à sua taxa de fluxo, pH e capacidade de tamponamento. Os resultados primários são as diferenças nas taxas de fluxo salivar entre G1 e G2. Os resultados secundários são as diferenças no pH salivar e na capacidade de tamponamento entre G1 e G2. Discussão: Os resultados desse ensaio clínico oferecerão evidências da eficácia da fotobiomodulação nos parâmetros salivares e apoiarão a tomada de decisões em relação a tratamentos não invasivos para o controle da cárie dentária.

Irrigation protocols effects on radicular dentin: Cleaning, disinfection and remaining ultrastructure / Efecto del protocolo de irrigación en la dentina radicular: limpieza, desinfección y ultraestructura remanente

A successful endodontic treatment requires a combination of satisfactory mechanical instrumentation, adequate irrigation protocols, and three-dimensional obturation of the canal system. Irrigation is considered the most critical procedure to ensure cleaning and disinfection. To date, a large variety of irrigants has been proposed. However, sodium hypochlorite (NaOCl) remains the gold standard. In order to achieve complete cleaning and disinfection, final irrigation with EDTA and ultrasonic devices has been used as an ideal protocol. Most endodontic research focuses on the cleaning and antibacterial properties of the irrigant solutions. Recent evidence demonstrated that the irrigation protocols cause erosion, affecting the radicular dentin ultrastructure. This article aims to describe the clinical features of the present knowledge concerning the effect of irrigation protocols on radicular dentin.

Un tratamiento de endodoncia exitoso requiere de una satisfactoria instrumentación mecánica, protocolos de irrigación adecuados y obturación tridimensional del sistema de conductos radiculares. La irrigación se considera el procedimiento más crítico para garantizar la limpieza y desinfección. Hasta la fecha, se ha propuesto una gran variedad de irrigantes. Sin embargo, el hipoclorito de sodio (NaOCl) sigue siendo el estándar de oro. Para lograr una limpieza y desinfección completa, se ha utilizado como protocolo ideal la irrigación final con EDTA y dispositivos ultrasónicos. La mayor parte de la investigación en endodoncia se enfoca en las propiedades antibacterianas y de limpieza de las soluciones de irrigación. Reciente evidencia demostró que los protocolos de irrigación provocan erosión, afectando la ultraestructura de la dentina radicular. Este artículo tiene como objetivo describir algunas consideraciones clínicas del conocimiento actual sobre el efecto de los protocolos de irrigación en la dentina radicular.

Management of Diabetic Macular Edema Through Ayurveda: A Single Case Study

Diabetic macular edema is one of the leading causes of visual acuity loss in people with diabetes. It produces blurry vision, particularly in the centre of the vision field, floaters and black spots in front of the eyes etc. The treatment recommended by modern science is laser photocoagulation and anti-VEGF injection, which is pricey and does not ensure visual reversal in the patient. In Ayurveda text, diabetic retinopathy and diabetic macular edema are not directly described but etiopathogenesis of eye diseases and Prameha gives an idea of possible correlation between these two diseases. So, DME resembles Timira (Pramehajanya). In Ayurveda, Timira has been explained in detail by our Acharyas. Clinical manifestations of Timira are Vihwal Drishti (blurred vision), Makshika Mashaka Kesha Jaala Pashyati (floaters), Tamasa Darshanam (Scotoma- black spots in front of eyes) and Nasa Akshi Yuktani Vipritani Vikshate (Metamorphopsia or distorted vision) which has similarity with features of DME. Material & Methods: In the present study, a female patient aged 51 years, visited the Shalakya Tantra OPD of National Institute of Ayurveda, Jaipur, with complaining of Blurriness of vision since 6 months and uncontrolled blood sugar level. Result: Blood sugar level was controlled and saw reduction in subjective and objective parameters. Discussion: Following an Ayurvedic drugs and routine will assist to slow the advancement of the condition, prevent further diabetes complications, and improve quality of life.

Service organization protocol for coping with undergraduate students' psychological distress: a collective construction / Protocolo de organización de servicios para el enfrentamiento del malestar psicológico de estudiantes universitarios: una construcción colectiva / Protocolo de organização de serviço para enfrentamento do sofrimento psíquico de universitários: uma construção coletiva

ABSTRACT Objective: to report on the experience of the elaboration process of a service organization protocol for coping with public undergraduate students' psychological distress in the countryside of São Paulo. Method: experience report on protocol production, an action research product, carried out according to the health care and service organization protocol model, made possible by remote meetings with 33 professionals linked to the management and services of the university's health and social assistance departments. Results: collective protocol production provided an opportunity for an institutional agreement on educational, therapeutic and support actions, to be developed in groups or individually with students, with provision for permanent education with civil servants. Final considerations: this experience made it possible to list specific actions to face undergraduate students' psychological distress, bringing health professionals closer to those in management, promoting the exchange of concepts and practices to re-signify and transform the work developed.

RESUMEN Objetivo: relatar la experiencia del proceso de elaboración colectiva de un protocolo de organización de servicios para el enfrentamiento del malestar psicológico de estudiantes de una universidad pública del interior de São Paulo. Método: relato de experiencia sobre la elaboración del protocolo, producto de investigación-acción, realizado según el modelo de protocolo de organización asistencial y de servicios de salud, posibilitado por encuentros a distancia con 33 profesionales vinculados a la gestión y servicios de los departamentos de salud y asistencia sociales universitarios. Resultados: la producción colectiva del protocolo brindó oportunidad para un acuerdo institucional sobre acciones educativas, terapéuticas y de apoyo, a ser desarrolladas en grupo o individualmente con los estudiantes, con previsión de educación permanente con los servidores públicos. Consideraciones finales: esta experiencia permitió enumerar acciones específicas para enfrentar el sufrimiento psíquico de estudiantes universitarios, acercando a los profesionales de la salud a los profesionales de la gestión, promoviendo el intercambio de conceptos y prácticas para resignificar y transformar el trabajo desarrollado.

RESUMO Objetivo: relatar experiência sobre o processo de elaboração coletiva de protocolo de organização de serviço para enfrentamento do sofrimento psíquico de estudantes de universidade pública do interior paulista. Método: relato de experiência da produção do protocolo, produto de pesquisa-ação, realizada conforme modelo de protocolo de cuidado à saúde e de organização de serviço, viabilizada por encontros remotos com 33 profissionais vinculados à gestão e aos serviços dos departamentos de saúde e assistência social da universidade. Resultados: a produção coletiva do protocolo oportunizou a pactuação institucional de ações educativas, terapêuticas e de apoio, para serem desenvolvidas em grupo ou individualmente com os estudantes, sendo previstas as de educação permanente com os servidores. Considerações finais: esta experiência possibilitou elencar ações específicas para o enfrentamento do sofrimento psíquico de estudantes universitários, aproximando profissionais da assistência aos da gestão, promovendo intercâmbio de concepções e práticas para ressignificar e transformar o trabalho desenvolvido.

Linfoma de células B de alto grado de malignidad con morfología blastoide durante el embarazo: reporte de un caso / High-grade malignant B-Cell lymphoma with blastoid during pregnancy: a case report

Resumen ANTECEDENTES: Durante el embarazo es más común el linfoma de Hodking que el no Hodking; afecta, en promedio, a mujeres de 30 años (18-44 años) y más. Suele diagnosticarse alrededor de las 28 semanas de embarazo y está documentado que puede llegarse al término. Los esquemas de tratamiento pueden iniciarse en el posparto inmediato o, incluso, antes. La incidencia mundial del linfoma no Hodking es de 0.8 por cada 100,000 mujeres; se desconoce la supervivencia durante el embarazo. CASO CLINICO: Paciente de 34 años, con antecedentes obstétricos de tres embarazos, una cesárea y un aborto y el embarazo actual en curso de las 29 semanas, referida de la ciudad de Colima debido a un reporte de BI-RADS 3 en el ultrasonido de mama y un nódulo mamario palpable, con evidencia de múltiples tumoraciones en la zona hepática, esplénica y peripancreática. La biopsia tomada de las zonas de la lesión reportó: linfoma de células B de alto grado de malignidad, con morfología blastoide y expresión de C-MYC y BCL2. Además, la paciente se encontró con: anemia, dolor abdominal, múltiples nódulos hepáticos y adenopatías abdominales. Se decidió la interrupción del embrazo a las 30 semanas, con la obtención de un recién nacido, sin complicaciones. Enseguida se inició el tratamiento con rituximab-etopósido-prednisolona-vincristina-ciclofosfamida-doxorrubicina (R-EPOCH) con adecuada adaptación por la paciente. CONCLUSION: Puesto que la información bibliográfica de linfoma y embarazo es escasa el caso aquí reportado es relevante por su aporte. La atención multidisciplinaria favorecerá siempre el pronóstico de las pacientes.

Abstract BACKGROUND: Hodking's lymphoma is more common during pregnancy than non-Hodking's lymphoma; it affects, on average, women aged 30 years (18-44 years) and older. It is usually diagnosed around 28 weeks of pregnancy and is documented to be carried to term. Treatment regimens can be initiated in the immediate postpartum period or even earlier. The worldwide incidence of non-Hodking's lymphoma is 0.8 per 100,000 women; survival during pregnancy is unknown. CLINICAL CASE: 34-year-old patient, with obstetric history of three pregnancies, one cesarean section and one abortion and the current pregnancy in progress at 29 weeks, referred from the city of Colima due to a report of BI-RADS 3 on breast ultrasound and a palpable breast nodule, with evidence of multiple tumors in the hepatic, splenic and peripancreatic area. Biopsy taken from the lesion areas reported: high grade malignant B-cell lymphoma, with blastoid morphology and expression of C-MYC and BCL2. In addition, the patient was found to have: anemia, abdominal pain, multiple hepatic nodules and abdominal adenopathies. It was decided to terminate the pregnancy at 30 weeks, with the delivery of an uncomplicated newborn. Rituximab-Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (R-EPOCH) therapy was started immediately with adequate adaptation by the patient. CONCLUSION: Since bibliographic information on lymphoma and pregnancy is scarce, the case reported here is relevant for its contribution. Multidisciplinary care will always favor the prognosis of patients.

Proposta de Pesquisa Científica para Avaliação da Segurança Microbiológica de Queijos Artesanais fabricados com leite cru e maturados por período inferior a 60 dias produzidos no estado de São Paulo / Scientific Research Proposal for the Microbiological Safety Evaluation of Raw Milk Artisanal Cheeses Ripened for Less than 60 Days in the State of São Paulo

Introdução: No Brasil, a legislação exige maturação mínima de 60 dias para queijos produzidos com leite cru, salvo se houver comprovação científica de que a redução do prazo não compromete a segurança do produto, como ocorreu com alguns queijos artesanais tradicionais de diferentes regiões do estado de Minas Gerais. No estado de São Paulo, onde os produtores seguem formulações e processos específicos individuais, a falta de um padrão de pesquisa validado dificulta a avaliação da segurança microbiológica deste tipo de queijo, pois essas pesquisas são dispendiosas e não há garantia de que os parâmetros estabelecidos pelos pesquisadores seriam aceitos pelos serviços de inspeção. Objetivo: Para abordar este desafio, esta proposta visa estabelecer um modelo de pesquisa científica padronizado para avaliar a segurança de queijos de leite cru maturados por menos de 60 dias. Métodos: Com base na proposta do DIPOA para classificação de Risco de Estabelecimentos, foi criado um checklist para classificação dos estabelecimentos/produtos, considerando risco do produto, volume processado e características de desempenho do estabelecimento em relação às Boas Práticas de Fabricação.  Resultados: A pontuação obtida pela aplicação do checklist na produção do queijo em questão determina o risco do produto como baixo, médio, alto ou muito alto e auxilia no estabelecimento do número mínimo de amostras a serem avaliadas mensalmente. Discussão: Espera-se que essa pesquisa auxilie produtores e órgãos de registro, fiscalização e inspeção no processo de legalização dos queijos artesanais de leite cru, possibilitando o desenvolvimento rural e a fixação de mão de obra no campo. (AU)

Introduction: In Brazil, the legislation requires a minimum ripening period of 60 days for raw milk cheeses, unless scientific evidence shows that the reduction in the ripening time does not compromise food safety, as seen with traditional artisanal cheeses from the state of Minas Gerais. In the state of Sao Paulo, where many producers have developed their own specific formulations and processes, the lack of a standardized validated research protocol for these types of cheese hinders their microbiological safety evaluation, since this type of research is costly and there are no guarantees that the parameters stablished by the researchers would be accepted by the inspection services. Objectives: To address this challenge, this proposal aims to stablish a standardized scientific research protocol for assessing the safety of raw milk cheeses ripened for less than 60 days. Methods: Based on the DIPOA (Department of Inspection of Products of Animal Origin) risk classification model for establishments, a checklist was created to categorize establishments/products, taking into consideration the product's risk, processed volume, and the establishment's performance assessed on the basis of good manufacturing practices. Results: The score obtained through the checklist application determines the final risk level of the product, categorized as low, medium, high, or very high, and helps determining the minimum number of samples to be evaluated monthly. Discussion: This research protocol may help producers, regulatory, inspection, and registration bodies in the legalization process of raw milk artisanal cheeses, enabling rural development and fixation of workforce in rural settings. (AU)

Effect of radiotherapy on the differentiation and osteogenic activity of mesenchymal stem cells on dental implants / Efeito da radioterapia na diferenciação e atividade osteogênica de células-tronco mesenquimais em implantes dentários

Objective: to evaluate the differentiation and gene expression of transcripts related to osteogenesis in a primary culture of Mesenchymal Stem Cells (MSCs) derived from rat femurs submitted to radiotherapy and the installation of pure titanium implants. Material and Methods: fifty-four rats received titanium implants in both femurs and were divided into three groups: Control: implant surgery (C); Implant + immediate irradiation (IrI), and Implant + late irradiation (IrL). Euthanasia occurred 3, 14, and 49 days after surgery. The bone marrow MSCs from the femurs were isolated and cultivated. The cell viability, total protein content, alkaline phosphatase (ALP) activity, and the formation of mineralization nodules and cellular genotoxicity were analyzed. The gene expression of Alkaline Phosphatase (phoA), Collagen 1 (COL1), Runt-related transcription factor 2 (RUNX2), Osterix (OSX), Osteopontin (OPN), Integrin ß1(ITGB1), Bone Sialoprotein (BSP), Osteonectin (SPARC), Osteocalcin (Bglap), Transforming Growth Factor ß-type (TGF-ß), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), Interleukin-6 (IL-6), Apolipoprotein E (APOE) and Prostaglandin E2 synthase (PGE2) were evaluated by qRT- PCR. Results: ionizing radiation suppresses the gene expression of essential transcripts for bone regeneration, as well as cellular viability, as observed in the IrI and IrL groups. Conclusion: although this can lead to the loss of osseointegration and failure of the implant, the MSCs showed more activity at 49 days than at 3 and 14 days. (AU)

Objetivo: avaliar a diferenciação e expressão gênica de transcritos relacionados à osteogênese em cultura primária de MSCs derivadas de fêmures de ratos submetidos à radioterapia e instalação de implantes de titânio puro. Material e Métodos: cinquenta e quatro ratos receberam implantes de titânio em ambos os fêmures e foram divididos em três grupos: Controle: cirurgia de implante (C); Implante + irradiação imediata (IrI) e Implante + irradiação tardia (IrL). A eutanásia ocorreu 3, 14 e 49 dias após a cirurgia. As MSCs de medula óssea dos fêmures foram isoladas e cultivadas. Foram analisadas a viabilidade celular, teor de proteína total, atividade da fosfatase alcalina (ALP), formação de nódulos de mineralização e genotoxicidade celular. A expressão gênica de Fosfatase Alcalina (phoA), Colágeno 1 (COL1), fator de transcrição relacionado a Runt 2 (RUNX2), Osterix (OSX), Osteopontina (OPN), Integrina ß1 (ITGB1), Sialoproteína Óssea (BSP), Osteonectina (SPARC), Osteocalcina (Bglap), Fator de Crescimento Transformador tipo ß (TGF-ß), Fator Estimulante de Colônia de Granulócitos-Macrófagos (GM-CSF), Interleucina-6 (IL-6), Apolipoproteína E (APOE) e Prostaglandina E2 sintase (PGE2) foram avaliados por qRT-PCR. Resultados: a radiação ionizante suprime a expressão gênica de transcritos essenciais para a regeneração óssea, bem como a viabilidade celular, como observado nos grupos IrI e IrL. Conclusão:embora isso possa levar à perda da osseointegração e falha do implante, as MSCs apresentaram maior atividade aos 49 dias do que aos 3 e 14 dias (AU)