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BACKGROUND/AIM: London Protocol (LP) and Classification allied to high-resolution manometry (HRM) technological evolution has updated and enhanced the diagnostic armamentarium in anorectal disorders. This study aims to evaluate LP reproducibility under water-perfused HRM, provide normal data and new parameters based on 3D and healthy comparison studies under perfusional HRM. METHODS: Fifty healthy (25 F) underwent water-perfused 36 channel HRM based on LP at resting, squeeze, cough, push, and rectal sensory. Additional 3D manometric parameters were: pressure-volume (PV) 104mmHg2.cm (resting, short and long squeeze, cough); highest and lowest pressure asymmetry (resting, short squeeze, and cough). Complementary parameters (CP) were: resting (mean pressure, functional anal canal length); short squeeze (mean and maximum absolute squeeze pressure), endurance (fatigue rate, fatigue rate index, capacity to sustain); cough (anorectal gradient pressure); push (rectum-anal gradient pressure, anal canal relaxation percent); recto-anal inhibitory reflex (anal canal relaxation percent). RESULTS: No difference to genders: resting (LP, CP, and 3D); short squeeze (highest pressure asymmetry); endurance (CP); cough (CP, highest and lowest pressure asymmetry); push (gradient pressure); rectal sensory. Higher pressure in men: short squeeze (maximum incremental, absolute, and mean pressure, PV, lowest pressure asymmetry); long squeeze (PV); cough (anal canal and rectum maximum pressure, anal canal PV); push (anal canal and rectum maximum pressure). Anal canal relaxation was higher in women (push). CONCLUSIONS: LP reproducibility is feasible under water-perfused HRM, and comparative studies could bring similarity to dataset expansion. Novel 3D parameters need further studies with healthy and larger data to be validated and for disease comparisons. KEY POINTS: • London Protocol and Classification allied with the technological evolution of HRM (software and probes) has refined the diagnostic armamentarium in anorectal disorders. • Novel 3D and deepening the analysis of manometric parameters before the London Classification as a contributory diagnostic tool. • Comparison of healthy volunteers according to the London Protocol under a perfusional high-resolution system could establish equivalence points.

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Fundamento: La ultrasonografía del diámetro de la vaina del nervio óptico ha sido utilizada como medidor no invasivo de la presión intracraneal. Una de las deficiencias enunciadas resulta, la no existencia de un valor estándar, que sugiera el límite entre la normalidad y la hipertensión intracraneal. Objetivo: Determinar el diámetro de la vaina del nervio óptico mediante ecografía en voluntarios sanos. Métodos: Se realizó un estudio ecológico de poblaciones múltiples en 160 voluntarios sanos que cumplieron con los criterios de inclusión. Se realizaron 3 mediciones ultrasonográficas en modo B en cada ojo, se tomó como valor final el promedio. Las variables estudiadas fueron: edad, sexo, color de la piel y diámetro de la vaina del nervio óptico. Se calculó el porcentaje, media, mediana, límite y estándar. Con un valor de referencia al 95 % del intervalo de confianza. La relación entre las variables se determinó mediante análisis de regresión logística simple con el paquete estadístico de SPSS 22.0. Resultados: El diámetro de la vaina del nervio óptico, en los sujetos, se cuantificó entre 4,62 - 4,80 mm y 4,66 - 4,83 mm para los ojos derecho e izquierdo respectivamente. Al análisis de regresión lineal simple, solo el sexo se asoció al valor del diámetro de la vaina del nervio óptico (p= 0,000). Conclusiones: En una población de voluntarios sanos el valor del diámetro de la vaina del nervio óptico fue similar a otras descripciones, con diferencias entre el sexo, lo cual sugiere tomar en consideración esta variable al hacer la medición.

Foundation: Ultrasonography of the diameter of the optic nerve sheath has been used as a non-invasive measure of intracranial pressure. One of the deficiencies stated is the non-existence of a standard value that suggests the limit between normality and intracranial hypertension. Objective: Determine the diameter of the optic nerve sheath using ultrasound in healthy volunteers. Methods: A multi-population ecological study was conducted on 160 healthy volunteers who met the inclusion criteria. Three ultrasonographic measurements were performed in B mode in each eye, the average was taken as the final value. The variables studied were: age, sex, skin color and diameter of the optic nerve sheath. The percentage, mean, median, limit and standard were calculated. With a reference value at the 95% confidence interval. The relationship between the variables was determined by simple logistic regression analysis with the SPSS 22.0 statistical package. Results: That diameter of the optic nerve sheath, in the subjects, was quantified between 4.62 - 4.80 mm and 4.66 - 4.83 mm for the right and left eyes respectively. In the simple linear regression analysis, only sex was associated with the value of the diameter of the optic nerve sheath (p= 0.000). Conclusions: In a population of healthy volunteers, the value of the diameter of the optic nerve sheath was similar to other descriptions, with differences between sex, which suggests taking this variable into consideration when making the measurement.

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Introduction The number of stimuli is important to determine the quality of auditory evoked potential records. However, there is no consensus on that number in studies, especially in the sample studied. Objectives To investigate the influence of the number of rare stimuli on forming N2 and P3 components, with different types of acoustic stimuli. Methods Cross-sectional, descriptive, comparative study, approved by the ethics committee of the institution. The sample comprised 20 normal hearing adults of both sexes, aged 18 to 29 years old, with normal scores in the mental state examination and auditory processing skills. The event-related auditory evoked potentials were performed with nonverbal (1 kHz versus 2 kHz) and verbal stimuli (/BA/ versus /DA/). The number of rare stimuli varied randomly in the recordings, with 10, 20, 30, 40, and 50 presentations. Results P3 latency was significantly higher for nonverbal stimuli with 50 rare stimuli. N2 latency did not show any difference between the type and number of stimuli. The absolute P3 and N2-P3 amplitudes showed significant differences for both types of stimuli, with higher amplitude for 10 rare stimuli, in contrast with the other ones. The linear tendency test indicated significance only for the amplitude - as the number of rare stimuli increased, the amplitude tended to decrease. Conclusion The components were identifiable in the different numbers of rare stimuli and types of stimuli. The P3 and N2-P3 latency and amplitude increased with fewer verbal and nonverbal stimuli. Recording protocols must consider the number of rare stimuli.

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Introduction: Serum vitamin D levels depend on sunlight, diet, and other factors. Objective: We aimed to determine serum vitamin D levels and evaluate their relationship with anthropometric indicators and lifestyle habits in apparently healthy volunteers. Materials and Methods: In this cross-sectional study (n=75), socio-demographic, anthropometric, and lifestyle habit-related data were collected. Serum vitamin D levels were determined with high performance liquid chromatography, food intake was measured by semiquantitative frequency and nutritional status was assessed by anthropometry. Chi-square test and also principal component analysis were used to analyze the relationship between some variables and vitamin D status. Spearman's test was used to determine correlations between quantitative variables. Results: 73% were women and 61% belonged to medium socio-economic level. Median vitamin D intake was 137 (83.1­227.3) IU/day. Based on body mass index (BMI), 44% individuals had overweight/obesity. The 68% exhibited deficient/insufficient vitamin D levels (Hypovitaminosis D). BMI classification and waist circumference (CW) were not related with vitamin D status; however, activities with higher sun exposure were highly related (p = 0.013). Sun exposure time explained variation in component 2 (16.60%), where most of the individuals with normal level were grouped. Sun exposure time was positively correlated with vitamin D status (r = 0.263; p = 0.023). Discussion: Excess weight and abdominal obesity are not always associated with hypovitaminosis D. Conclusions: The majority of individuals showed hypovitaminosis D but their status was not related with anthropometric indicators. A Sun exposure time was the only factor positively correlated with vitamin D status.

Introducción: Los niveles séricos de vitamina D dependen de la luz solar, la dieta y otros factores. Objetivo: Nuestro objetivo fue determinar los niveles séricos de vitamina D y evaluar su relación con indicadores antropométricos y estilos de vida en voluntarios aparentemente sanos. Materiales y métodos: En este estudio trasversal (n=75) se recogieron datos sociodemográficos, antropométricos y aquellos relacionados con hábitos y estilos de vida. La vitamina D se determinó por cromatografía liquida de alta eficiencia; la ingesta de alimentos, mediante frecuencia semicuantitativa, y el estado nutricional por antropometría. Para analizar la relación entre algunas variables y el estado de la vitamina D se usó la prueba de Chi cuadrado y también el análisis de componentes principales. Se empleó la prueba de Spearman para determinar la correlación entre variables cuantitativas. Resultados: El 73% eran mujeres y el 61% pertenecían a un estrato socioeconómico medio. La mediana de la ingesta de vitamina D fue de 137 (83,1­227,3) UI/día. Según el índice de masa corporal (IMC), el 44% de los individuos tenían sobrepeso/obesidad. El 68% mostro deficiencia/insuficiencia de vitamina D (hipovitaminosis D). La clasificación del IMC y la circunferencia abdominal no se relacionaron con el estado de la vitamina D; sin embargo, las actividades con una mayor exposición solar estuvieron altamente relacionadas (p=0,013). El tiempo de exposición solar explico la variación en el componente 2 (16,60%) donde se agruparon la mayoría de los individuos con niveles normales. El tiempo de exposición solar tuvo una correlación positiva con el estado de la vitamina D (r = 0,263; p = 0,023). Discusión: El exceso de peso y la obesidad abdominal no siempre se relacionan con la hipovitaminosis D. Conclusiones: La mayoría de los individuos presentaron hipovitaminosis D, pero su estado no se relacionó con los indicadores antropométricos. El tiempo de exposición al sol fue el único factor que se correlaciono positivamente con el estado de la vitamina D.

Introdução: Os níveis séricos de vitamina D dependem da luz solar, da dieta e de outros fatores. Objetivo: Nosso objetivo foi determinar os níveis séricos de vitamina D e avaliar sua relação com indicadores antropométricos e hábitos de vida em voluntários aparentemente saudáveis. Materiais e métodos: Neste estudo transversal (n=75), foram coletados dados sociodemográficos, antropométricos e relacionados a hábitos de vida. Os níveis séricos de vitamina D foram determinados por cromatografia liquida de alto desempenho, a ingestão de alimentos foi medida por frequência semiquantitativa e o estado nutricional foi avaliado por antropometria. O teste do qui-quadrado e a análise de componentes principais foram utilizados para analisar a relação entre algumas variáveis e o estado da vitamina D. O teste de Spearman foi usado para determinar as correlações entre as variáveis quantitativas. Resultados: 73% eram mulheres e 61% pertenciam a um nível socioeconômico médio. A ingestão media de vitamina D foi de 137 (83,1-227,3) UI/dia. Com base no índice de massa corporal (IMC), 44% dos indivíduos tinham sobrepeso/obesidade. Os 68% apresentaram níveis deficientes/insuficientes de vitamina D (hipovitaminose D). A classificação do IMC e a circunferência da cintura (CW) não foram relacionadas ao status da vitamina D; entretanto, as atividades com maior exposição ao sol foram altamente relacionadas (p = 0,013). O tempo de exposição ao sol explicou a variação no componente 2 (16,60%), onde a maioria dos indivíduos com nível normal foi agrupada. O tempo de exposição ao sol foi positivamente correlacionado com o status de vitamina D (r = 0,263; p = 0,023). Discussão: O excesso de peso e a obesidade abdominal nem sempre estão associados com a hipovitaminose D. Conclusões: A maioria dos indivíduos apresentou hipovitaminose D, mas seu status não foi relacionado com indicadores antropométricos. O tempo de exposição ao sol foi o único fator positivamente correlacionado com o status da vitamina D.

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Los ensayos clínicos en Fase I se realzan con la participación de voluntarios sanos de prueban la seguridad y tolerabilidad de los productos farmacéuticos en investigación. En ellos, los participantes están expuestos a riesgos de medicamentos del estudio sin la posibilidad de un beneficio médico directo y, por lo general, deben pasar días o semanas en un centro de investigación. Los incentivos, como pagos monetarios se utilizan para incentivar la inscripción y compensar a los participantes por su tiempo. Estas características de los ensayos voluntarios sanos de fase I crean un contexto de investigación que difiere notablemente de la mayoría de las otras investigaciones clínicas, pues la mayoría de ellos son personas vulnerables económicamente. Este artículo presenta el objetivo de analizar factores bioéticos que inciden en el otorgamiento de incentivos a participantes voluntarios sanos en investigaciones Fase I.

Phase I Clinical Trials are conducted with the participation of healthy volunteers to test the safety and tolerability of pharmaceutical products. In them, participants are exposed to study drug risks without the possibility of direct medical benefit and usually must spend days or weeks at a research site. Incentives such as monetary payments are used to encourage enrollment and compensate participants for their time. These characteristics of Phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, as most of them are financially vulnerable individuals. This paper aims to analyze bioethical factors that influence the granting of incentives to healthy volunteer participants in Phase I research.

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Introduction: In the hyperbaric pressure environment the partial pressure of each gas component increases, which increases oxygen partial pressure. This causes the generation of free radicals and oxidative stress. Objective: To determine the effects of hyperbaric pressure on the oxidative stress status in healthy subjects. Methods: 29 healthy men performed standardized hyperbaric chamber dive to a depth of 30 meters of water (msw) for 30 minutes. Blood samples were collected before compression, immediately after decompression and 1 hour after decompression. The levels of Malondialdehyde, Catalase and Superoxide Dismutase were measured in blood samples. Results: Malondialdehyde activity increased immediately after decompression and recovered at 1 hour after decompression. Superoxide Dismutase enzyme activity decreased immediately after decompression as well as 1 hour after decompression. Catalase enzyme activity increased immediately after decompression, which was significant at 1 hour after decompression. Conclusion: Changes in the biological markers Malondialdehyde, Catalase and Superoxide Dismutase suggest the appearance of oxidative stress under the influence of a hyperbaric pressure environment.

Introducción: En la condición de presión hiperbárica, la presión parcial de los componentes del aire se encuentra aumentada, incluida la del oxígeno. Esto se considera la causa de formación de radicales libres y el estado de estrés oxidativo. Objetivo: Determinar los efectos de la presión hiperbárica sobre estado del estrés oxidativo en individuos sanos. Métodos: 29 hombres sanos realizaron buceo estandarizado en cámara hiperbárica, a una profundidad de 30 metros de agua, durante un tiempo total de 30 minutos. Se recogieron muestras de sangre antes de la compresión, inmediatamente después de la descompresión y una hora después. Se midieron los niveles de malondialdehído, catalasa y superóxido dismutasa en muestras de sangre. Resultados: La acción del malondialdehído se incrementó inmediatamente después del buceo y se recuperó en 1 hora. La acción de enzima superóxido dismutasa se encontró disminuida al término y 1 hora después, mientras la enzima catalasa se demostró lo contrario y aumentó significativamente en la primera hora. Conclusión: El cambio de los marcadores biológicos malondialdehído, catalasa y superóxido dismutasa sugiere estado de estrés oxidativo bajo la influencia de presión hiperbárica.

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Background:The combined supplementation of vitamins C and E potentially can mitigate oxidative stress (OS) and accelerate recovery following exercise. However, there is little evidence and a lack of consensus on the effects of these vitamins for this purpose. The objective of this systematic review was to summarize the evidence on the effects of the combined supplementation of vitamins C and E in OS, inflammatory markers, muscle damage, muscle soreness, and musculoskeletal functionality following acute exercise. Methods: The search was carried out from inception until March 2021, on MEDLINE, EMBASE, Cochrane CENTRAL, Web of Science, and SPORT Discus. We included placebo-controlled randomized clinical trials (RCTs) that evaluated the effects of combined supplementation of vitamins C and E in OS, inflammatory markers, muscle damage, muscle soreness, and muscle strength following a single bout of exercise. Random-effect meta-analyses were used to compare pre to post-exercise mean changes in subjects who received supplementation with vitamins C and E or placebo versus controls. Data are presented as standard mean difference (SMD) and 95% confidence interval (95% CI). Results: Eighteen RCTs, accounting for data from 322 individuals, were included. The use of vitamins attenuated lipid peroxidation (SMD= -0.703; 95% CI= -1.035 to -0.372; p < 0.001), IL-6 (SMD= -0.576; 95%CI= -1.036 to -0.117; p = 0.014), and cortisol levels (SMD= -0.918; 95%CI= -1.475 to -0.361; p = 0.001) immediately, and creatine kinase levels 48 h following exercise (SMD= -0.991; 95%CI= -1.611 to -0.372; p = 0.002). Supplementing the combination of vitamins had no effects on protein carbonyls, reduced/oxidized glutathione ratio, catalase, interleukin-1Ra, C-reactive protein, lactate dehydrogenase, muscle soreness, and muscle strength. Conclusion: Prior supplementation of the combination of vitamins C and E attenuates OS (lipid peroxidation), the inflammatory response (interleukin-6), cortisol levels, and muscle damage (creatine kinase) following a session of exercise.

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Abstract Introduction The number of stimuli is important to determine the quality of auditory evoked potential records. However, there is no consensus on that number in studies, especially in the sample studied. Objectives To investigate the influence of the number of rare stimuli on forming N2 and P3 components, with different types of acoustic stimuli. Methods Cross-sectional, descriptive, comparative study, approved by the ethics committee of the institution. The sample comprised 20 normal hearing adults of both sexes, aged 18 to 29 years old, with normal scores in the mental state examination and auditory processing skills. The event-related auditory evoked potentials were performed with nonverbal (1 kHz versus 2 kHz) and verbal stimuli (/BA/ versus /DA/). The number of rare stimuli varied randomly in the recordings, with 10, 20, 30, 40, and 50 presentations. Results P3 latency was significantly higher for nonverbal stimuli with 50 rare stimuli. N2 latency did not show any difference between the type and number of stimuli. The absolute P3 and N2-P3 amplitudes showed significant differences for both types of stimuli, with higher amplitude for 10 rare stimuli, in contrast with the other ones. The linear tendency test indicated significance only for the amplitude - as the number of rare stimuli increased, the amplitude tended to decrease. Conclusion The components were identifiable in the different numbers of rare stimuli and types of stimuli. The P3 and N2-P3 latency and amplitude increased with fewer verbal and nonverbal stimuli. Recording protocols must consider the number of rare stimuli.

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RESUMO Objetivo mapear as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis. Estratégia de pesquisa trata-se de uma revisão de escopo baseada na questão de pesquisa: "Quais as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis?" A busca foi realizada de forma eletrônica nas bases de dados MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase e Cochrane. Critérios de seleção a seleção dos estudos foi baseada na leitura dos títulos, resumos, palavras-chave e textos completos, aplicando-se os critérios de elegibilidade. Foram extraídos os dados relacionados às informações bibliográficas da publicação, características da amostra e da intervenção, os efeitos da intervenção nas medidas de autoavaliação, perceptivo-auditivas, acústicas, aerodinâmicas, eletroglotográficas, resultado do exame laríngeo, entre outros. Os dados foram resumidos e apresentados de forma quantitativa e descritiva. Resultados foram selecionados 97 artigos, entre os 979 estudos mapeados nesta revisão. A análise acústica foi a medida mais utilizada (n=70, 72,3%) para verificar os efeitos do treinamento vocal nos estudos selecionados, seguida pela eletroglotografia (n= 55, 56,7%), autoavaliação (n= 38, 39,2%), aerodinâmica (n= 33, 34,0%), julgamento perceptivo-auditivo (n= 22, 22,7%) e exame laríngeo (n= 16, 16,5%). Conclusão a análise acústica é a medida utilizada na maioria dos estudos para verificar o efeito da intervenção em indivíduos vocalmente saudáveis.

ABSTRACT Purpose to map the vocal assessment measures used to verify the effect of the intervention in vocally healthy individuals. Research strategy This is a scope review based on the research question: What vocal assessment measures are used to verify the effect of the intervention in vocally healthy individuals? The search was carried out electronically in MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase and Cochrane databases. Selection criteria The selection of studies was based on reading the titles, abstracts, keywords and full texts, applying the eligibility criteria. Data related to the publication's bibliographic information, sample and intervention characteristics, the effects of the intervention on self-assessment, auditory-perceptual, acoustic, aerodynamic, electroglottographic measures, laryngeal examination results, among others, were extracted. The data were summarized and presented in a quantitative and descriptive way. Results 97 articles were selected, among the 979 studies mapped in this review. Acoustic analysis was the most used measure (n=70, 72.3%) to verify the effects of vocal training in the selected studies, followed by electroglottography (n= 55, 56.7%), self-assessment (n= 38, 39 .2%), aerodynamics (n= 33, 34.0%), auditory-perceptual judgment (n= 22, 22.7%) and laryngeal examination (n= 16, 16.5%). Conclusion Acoustic analysis is the measure used in most studies to verify the effect of the intervention in vocally healthy individuals.

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Most transcutaneous electric diaphragmatic stimulation (TEDS) studies use a stimulation frequency (SF) of 30 Hz, although the reason for this SF value is not completely understood. Objective:The purpose of this study was to compare the acute effect of two TEDS frequencies on the respiratory muscle strength and endurance, muscle activation, muscle thickness, diaphragmatic mobility, cardiovascular variables and safety in healthy subjects. Methods:Randomized crossover clinical trial with 20 healthy subjects subjected to two interventions: SF=30 Hz group and SF=80 Hz group. TEDS was applied at the diaphragm motor points with a symmetric biphasicpulsed current (pulse duration= 500 µs) for 30 minutes. The evaluated outcomes were systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory muscle strength by maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), inspiratory peak flux (PIF), diaphragm thickness during inspiration (DTI) and expiration (DTE), diaphragm mobility and activation, and endurance (S-Index). Results:SF-30 Hz showed a reduction with respect to baseline values for SBP (p=0.04), HR (p<0.001), DTE (p=0.02), IPF (p=0.01), and S-Index (p=0.03). SF-80 Hz showed a reduction with respect to baseline values for HR (p<0.001) and an increase in MEP (p<0.001). However, these changes were not clinically important and there were no between-groups differences for any of the evaluated outcomes. No complications were observed. Conclusion:TEDS with SF-80 Hz produces similar effects to SF-30 Hz in healthy subjects and bothfrequencies proved to be safe (NCT03844711).

A maioria dos estudos utilizam a estimulação diafragmática elétrica transcutânea (EDET) com frequência (F) de estímulo de 30Hz e testar diferentes frequências torna-se necessário para uma aplicação otimizada. Objetivo: Foi comparar o efeito agudo de duas frequências diferentes da EDET sobre a força muscular respiratória e endurance, ativação diafragmática, espessura muscular e mobilidade diafragmática, variáveis cardiovasculares e segurança em indivíduos saudáveis. Métodos: Estudo randomizado cruzado com 20 indivíduos saudáveis submetidos a duas intervenções: Grupo I com F= 30Hz e Grupo II com F= 80Hz. A aplicação foi nos pontos motores do diafragma, com duração do pulso de 500µs, durante 30 minutos. Foram avaliados a pressão arterial sistólica (PAS) e diastólica (PAD), frequência cardíaca (FC), força muscular respiratória pela pressão inspiratória máxima (PImax), pressão expiratória máxima (PEmax), endurance e espessura muscular em inspiração (EDI) e expiração (EDE), mobilidade e ativação diafragmática. Resultados: O GI apresentou redução significativa em comparação às condições basais para os desfechos de PAS (p= 0.04), FC (p<0.001), EDI (p= 0,02), PIF (p= 0.01), e S-Index (p= 0.03). O GII apresentou redução significativa em comparação às condições basais para FC (p<0.001) e aumento da PEmax (p<0.001). Porém, estas alterações não foram clinicamente importantes e não houve diferença entre os grupos para nenhum desfecho avaliado. Nenhuma intercorrência foi observada. Conclusão: A EDET com F-80Hz produz efeitos semelhantes a F-30Hz em indivíduos saudáveis e ambas as frequências provaram ser seguras (NCT03844711).

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Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.

A pesquisa médica é essencial para desenvolver novas e melhores terapias, aumentar os padrões sociais e uma vida melhor para todos nós. A curiosidade científica ajudou a alcançar muitas inovações bem-sucedidas, mas a história também demonstra que a pesquisa pode conduzira abusos de indivíduos, negligenciando a autonomia e a integridade do ser humano. Desde a década de 1960, temos testemunhado um desenvolvimento contínuo de regulamentos internacionais e de diretrizes éticas (soft law) em pesquisa médica, levando a resultados científicos de maior qualidade. Um foco importante está no reconhecimento da vulnerabilidade humana e, consequentemente, num procedimento de consentimento informado adaptado. A nossa estrutura moderna de ensaios clínicos requer a inclusão de voluntários saudáveis nas primeiras fases do desenvolvimento de um novo medicamento, suscitando novas questões e desafios éticos. A pandemia de coronavírus acelerou o desenvolvimento de vacinas de uma forma bem-sucedida, contribuindo também para uma maior importância de voluntários saudáveis no cenário da pesquisa médica.

La investigación médica es esencial para desarrollarterapias nuevas y mejores, aumentar los estándares sociales y una vida mejor para todos nosotros. La curiosidad científica ha ayudado a lograr muchas innovaciones exitosas, pero la historia también demuestra que la investigación puede conducir a abusos deindividuos que descuidan la autonomía y la integridad del ser humano.Desde la década de 1960 hemos sido testigos de un desarrollo continuo de las regulaciones internacionales y de las directriceséticas(soft law) en la investigación médica, lo que ha llevado a una mayor calidad de los resultados científicos. Un enfoque importante radica en el reconocimiento de la vulnerabilidad humana y, por lo tanto, en un procedimiento de consentimiento informado adaptado.Nuestra moderna estructura de ensayos clínicos requiere la inclusión de voluntarios sanos en las primeras fases del desarrollo de un nuevo medicamento, lo que genera nuevas cuestiones y desafíos éticos. La pandemia de coronavirus ha acelerado el desarrollo de vacunas de una manera exitosa, lo que también ha dado lugar a una nueva importancia de los voluntarios sanos en el panorama de la investigación médica.

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To compare joint ultrasound measurements between the sexes in healthy volunteers. A cross-sectional study compared the joint ultrasound measurements between the sexes in healthy volunteers. Quantitative (synovial hypertrophy and perpendicular measurement in the largest synovial recess) and semiquantitative (synovial hypertrophy, power Doppler, and bone erosion; score 0-3) ultrasound measurements were performed. Forty-six articular recesses were evaluated and compared between group 1 (100 females) and group 2 (60 males) who were matched by age and BMI. For the quantitative measurements, 7360 recesses were studied. For the semiquantitative measurements, 22,720 recesses were evaluated. Higher values (p < .05) were found in females for the quantitative measurements of synovial hypertrophy for the following: radiocarpal, distal radioulnar and ulnocarpal, second/third dorsal and second/third palmar interphalangeal, second palmar metacarpophalangeal, glenohumeral, hip, talocrural, talonavicular, and talocalcaneal recesses; the highest difference was found for the hip (6.21 ± 1.35 vs. 4.81 ± 2.40) and distal radioulnar (1.46 ± 0.40 vs. 1.07 ± 0.70) recesses. For the semiquantitative measurements, significant differences were found. For synovial hypertrophy, higher measurements for females in the second/third palmar metacarpophalangeal, second palmar proximal interphalangeal, hip, tibiotalar, talonavicular, talocalcaneal, and second metatarsophalangeal recesses (highest difference for second palmar metacarpophalangeal [44 (22.0%) vs. 5 (4.2%)]). For power Doppler, there were higher values for females in the talonavicular recesses and higher values for males in the first/second/fifth metatarsophalangeal recesses (highest difference for fifth [9 (7.5%) vs. 2 (1.0%)]). For bone erosion, there were higher measurements for females in the radiocarpal recesses (10 [5.0%] vs. 0 [0.0%]) and higher values for males in the talonavicular recesses (4 [3.3%] vs. 0 [0.0%]). Higher quantitative and semiquantitative ultrasound measurements of synovial hypertrophy were typically found in females.

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A ventilação voluntária máxima é um dos testes difundidos para avaliação da resistência da musculatura respiratória, mesmo sem ser validado para este fim. Na literatura ainda são encontradas controvérsias quanto a interpretação e aplicabilidade do uso da VVM na prática clínica. OBJETIVO: Verificar a correlação entre a ventilação voluntária máxima e a força e resistência dos músculos respiratórios em jovens hígidos. MATERIAIS E MÉTODOS: Estudo observacional de corte transversal realizado na Clínica. Foram incluídos indivíduos > 18 anos, de ambos os sexos e hígidos. Os participantes tiveram sua avaliação da força muscular respiratória através do manovacuômetro, no qual se obteve a Pimáx e Pemáx. A resistência foi avaliada através do teste de carga constante pelo Power Breathe, utilizando 60% da Pimáx. A ventilação voluntária máxima foi realizada pelo espirômetro. Para a correlação das variáveis Pimáx, Pemáx e VVM foi aplicado o teste de correlação de Pearson. O estudo foi aprovado pelo comitê de ética, CAAE 10849519.9.0000.5544. RESULTADOS: Foram avaliados 27 participantes, em que 59,3% eram do sexo masculino e 55,6% ativos. A ventilação voluntária máxima com a Pimáx e Pemáx, apresentaram respectivamente p = 0,04 e 0,02 e r = 0,53 e 0,57. CONCLUSÃO: O teste de ventilação voluntária máxima possui uma correlação moderada com a força muscular respiratória, e não obtém correlação com o teste de carga constante.

Maximum voluntary ventilation is one of the widespread tests for assessing respiratory muscle strength, even without being validated for this purpose. Controversies are still found in the literature regarding the interpretation and applicability of the use of MVV in clinical practice. OBJECTIVE: To verify the correlation between maximum voluntary ventilation and respiratory muscle strength and endurance in healthy youngsters. MATERIALS AND METHODS: Observational cross-sectional study conducted at the Clinic. Individuals> 18 years of age, of both sexes and healthy were included. Participants had their respiratory muscle strength assessment using a manovacuometer, in which Pimax and Pmax were obtained. The resistance was evaluated through the constant load test by Power Breathe, using 60% of the Pimáx. Maximum voluntary ventilation was performed by a spirometer. Pearson's correlation test was applied to correlate the variables Pimax, Pmax and VVM. The study was approved by the ethics committee, CAAE 10849519.9.0000.5544. RESULTS: 27 participants were evaluated, of which 59.3% were male and 55.6% were active. The maximum voluntary ventilation with Pimax and Pmax, presented respectively p = 0.04 and 0.02 and r = 0.53 and 0.57. CONCLUSION: The maximum voluntary ventilation test has a moderate correlation with respiratory muscle strength and has no correlation with the constant load test.

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BACKGROUND: Vitamin C (ascorbic acid) seems to attenuate the overproduction of reactive species during and after exercises. Yet, no meta-analysis has summarized the magnitude of this effect. The objective of this study was to systematically review the effects of vitamin C supplementation on oxidative stress, inflammatory markers, damage, soreness, and the musculoskeletal functionality after a single bout of exercise. METHODS: Major electronic databases were searched, from inception to September 2019, for placebo-controlled randomized clinical trials (RCTs) that evaluated the effects of vitamin C supplementation on oxidative stress parameters, inflammation markers, muscle damage, muscle soreness, and muscle functionality after a single bout of exercise in healthy volunteers. Random-effects modelling was used to compare mean changes from pre- to postexercise in participants that were supplemented with vitamin C versus placebo. Data were reported as standard mean difference (SMD) and 95% confidence interval (CI). RESULTS: A total of 18 RCTs, accounting for 313 participants (62% males, median age = 24 years) were included. Vitamin C supplementation reduced lipid peroxidation immediately (SMD = - 0.488; 95% CI = - 0.888 to - 0.088), 1 h (SMD = - 0.521; 95% CI = - 0.911 to - 0.131) and between 1 and 2 h (SMD = - 0.449; 95% CI = - 0.772 to - 0.126) following exercise. Exercise induced interleukin-6 (IL-6) response was attenuated 2 h (SMD = - 0.764; 95% CI = - 1.279 to - 0.248) and between 1 and 2 h (SMD = - 0.447; 95% CI = - 0.828 to - 0.065) after exercise. No effects of vitamin C supplementation were found on creatine kinase (CK), C-reactive protein (CRP), cortisol levels, muscle soreness, and muscle strength. CONCLUSION: Vitamin C supplementation attenuates the oxidative stress (lipid peroxidation) and inflammatory response (IL-6) to a single bout of exercise. REGISTRATION: PROSPERO (CRD42018094222).

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Introdução: A autoliberação miofascial com o Foam Roller (FR) ou Roller Massager (RM) pode ser uma intervenção que favorece a recuperação após exercícios. Objetivo: Revisar de forma integrativa os efeitos do FR ou RM sobre a dor e a funcionalidade musculoesquelética de voluntários saudáveis após a realização de exercícios. Métodos: Revisão integrativa da literatura. A busca foi realizada nas bases de dados Medline (PubMed), Cochrane Library, Biblioteca Virtual em Saúde e PeDro, sem restrições de ano de publicação ou idioma, através dos descritores em inglês "Healthy Volunteers"; "Exercise"; "Clinical Trial"; e das palavras-chave "Myofascial Release", "Foam Rolling", "Roller Massage". Resultados: Inicialmente a busca incluiu 84 estudos e posterior análise dos critérios de elegibilidade foram incluídos apenas quatro estudos. Nestes estudos a intervenção melhorou a percepção da dor e algumas variáveis funcionais, dentre estas, a amplitude de movimento, força, resistência, velocidade de reação e a potência após os exercícios. Conclusão: Os estudos demonstram que o FR ou RM reduziram a dor e melhoram algumas variáveis funcionais. No entanto, estes resultados ainda são inconsistentes pelo baixo número de estudos, carecendo de maior investigação para aumentar o nível de evidência e a aplicação da técnica nesta condição. (AU)

Introduction: Self-myofascial release with the Foam Roller (FR) or Roller Massager (RM) may be an intervention that favors recovery after exercise. Objective: To review in an integrative way the effects of FR or RM on pain and musculoskeletal function of healthy volunteers after exercise. Methods: Integrative literature review. The study was performed in the databases Medline (PubMed), Cochrane Library, Virtual Health Library and PeDro, without restrictions of year of publication or language, through the English descriptors "healthy volunteers"; "exercise"; "clinical trial"; and the key words "myofascial release", "foam rolling", "roller massage". Results: Initially the search included 84 studies and subsequent analysis of the eligibility criteria, only four studies were included. In these studies, the intervention improved the perception of pain and some functional variables, among them, the range of motion, strength, resistance, reaction speed and power after exercise. Conclusion: Studies show that FR or RM reduced pain and improved some functional variables. However, these results are still inconsistent due to the low number of studies, requiring further investigation to increase the level of evidence and the application of the technique in this condition. (AU)

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OBJETIVO: Avaliar os efeitos de um protocolo de fadiga global de curta duração sobre os parâmetros cinemáticos da marcha de indivíduos saudáveis. MÉTODOS: Fizeram parte da amostra 21 adultos jovens saudáveis. Foi realizada a análise de parâmetros da cinemática linear (velocidade, cadência, comprimento do passo, largura do passo e tempo do passo) e angular da marcha (flexão e extensão dos quadris; flexão e extensão dos joelhos; plantiflexão e dorsiflexão dos tornozelos) antes e após a realização de um protocolo de fadiga global de curta duração. Para a avaliação da marcha, foi utilizado um sistema de captura da trajetória tridimensional da marcha, composto por um sistema de cinemetria dotado de 7 câmeras integradas. O Protocolo de Fadiga de Agilidade Funcional de Curta Duração, que consiste em um protocolo de fadiga global de curta duração com séries de exercícios de agilidade funcional, foi utilizado para fadigar os participantes. Para as comparações entre as avaliações pré e pós-fadiga, os valores médios de cada avaliação foram utilizados e submetidos ao teste t pareado, e nível de significância adotado foi p<0,05. RESULTADOS: Não houveram diferenças estatisticamente significativas nos parâmetros angulares e lineares avaliados, exceto para cadência (p=0,03). CONCLUSÕES: O protocolo de fadiga global de curta duração não alterou os parâmetros angulares e cinemáticos da marcha em indivíduos jovens, exceto a cadência que se mostrou mais elevada após o protocolo de fadiga.

AIMS: Evaluate the effects of a short-term fatigue protocol on gait's kinematic parameters of healthy subjects. METHODS: 21 healthy young adults participated in the sample. The parameters of linear kinematics of gait (velocity, cadence, step length, step width, step time) and angular kinematics of gait (hip's flexion and extension; knee's flexion and extension; ankle's dorsiflexion and plantar flexion) were analyzed before and after performing a short-term fatigue protocol. For gait evaluation, a three-dimensional gait trajectory capture system was used, consisting of a kinematic system with 7 integrated cameras. The Short-Term Functional Agility Fatigue Protocol, which consists of a short-term global fatigue protocol with series of functional agility exercises, was used to fatigue participants. For comparisons between pre and post fatigue evaluations, the mean values to paired t test, and statistical significance was set as p<0.05. RESULTS: There were no statistically significant differences in the angular and linear parameters evaluated, except for cadence (p=0.03). CONCLUSIONS: The short-term global fatigue protocol did not alter the angular and kinematic gait parameters in young subjects, except for the cadence, that was higher after the fatigue protocol.

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The aim of this systematic review was to examine procedures used and outcome measures reported from surface EMG (sEMG) of extradiaphragm inspiratory muscles in healthy people. Relevant articles were searched using the concepts "electromyography (EMG)", "respiratory muscles (sternocleidomastoid [SM], scalene, intercostal [IC] and parasternal)" and "healthy" in the electronic databases: MEDLINE, PubMed, EMBASE, Cochrane CENTRAL and Database of Systematic Reviews, CINAHL, SPORTDiscus, LILACS, and PEDro. Twenty-five papers were included and quality assessment was performed using an adapted Downs and Black checklist. Twenty-eight percent of included papers were classified as moderate quality and the rest were low quality. The SM was the muscle most often investigated. Description of EMG techniques were often incomplete for features such as the procedure before electrode placement, description of the surface electrodes, the EMG detection mode and amplification. Of note, descriptions of the IC muscle electrode positioning varied widely. Comparison of outcomes among studies was challenging because of the very diverse EMG outcomes reported. There are many controversies regarding methods and technique used to assess sEMG of extradiaphragm inspiratory muscles. Therefore, studies with higher methodological quality utilizing standardized EMG procedures including electrode positioning will enable accurate and reliable comparison among studies of the extradiaphragm inspiratory muscles.

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BACKGROUND: Nebivolol is a drug available as a racemate of d-nebivolol (SRRR) and lnebivolol (RSSS). In human liver microsomes, CYP2D6 mainly catalyses the metabolism of lnebivolol, while CYP2C19 catalyses the metabolism of d-nebivolol. Nebivolol stereoselective pharmacokinetics has been described only for extensive metabolizers (EM). OBJECTIVE: To describe the stereoseletive nebivolol pharmacokinetics in CYP2D6 poor metabolizers (PM) and to assess whether the phenotype has an impact on nebivolol pharmacokinetics. METHODS: Three healthy volunteers PM phenotyped (ratios of 20.1, 220 and 244 for the 8 h urinary excretion of metoprolol/alfa-hydroxymetoprolol) received a single oral dose of racemic nebivolol and sequential blood samples were collected between zero (predose) and 48 h. RESULTS: The obtained data were compared to 22 EM subjects with normal kidney function enrolled in our previous study. For both isomers, Cmax, Tmax and AUC0-48 were significantly greater in the PM group compared to the EMs (p = 0.006 - 0.001). For d-nebivolol, Cmax, Tmax and AUC0-48 were, on average, 5.9, 2.7 and 15.0 larger in PMs. The corresponding values for l-nebivolol were 4.4, 2.7 and 17.5. CONCLUSION: The decline in plasma concentration of both nebivolol isomers in PM phenotypes, especially those with MR of 220 and 244, which indicate minimal or absent CYP2D6 activity, points to alternative mechanisms for nebivolol elimination. Collectively, our results are the first to show the significant impact of CYP2D6 PM phenotype on the metabolic disposition and in vivo exposure to both nebivolol isomers.

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BACKGROUND: Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans. METHODS: A phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment. RESULTS: Twenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values. CONCLUSIONS: NeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials RPCEC00000157 , June 10, 2013.

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The purpose of this study was to investigate whether the anxiolytic effect of cannabidiol (CBD) in humans follows the same pattern of an inverted U-shaped dose-effect curve observed in many animal studies. Sixty healthy subjects of both sexes aged between 18 and 35 years were randomly assigned to five groups that received placebo, clonazepam (1 mg), and CBD (100, 300, and 900 mg). The subjects were underwent a test of public speaking in a real situation (TPSRS) where each subject had to speak in front of a group formed by the remaining participants. Each subject completed the anxiety and sedation factors of the Visual Analog Mood Scale and had their blood pressure and heart rate recorded. These measures were obtained in five experimental sessions with 12 volunteers each. Each session had four steps at the following times (minutes) after administration of the drug/placebo, as time 0: -5 (baseline), 80 (pre-test), 153 (speech), and 216 (post-speech). Repeated-measures analyses of variance showed that the TPSRS increased the subjective measures of anxiety, heart rate, and blood pressure. Student-Newman-Keuls test comparisons among the groups in each phase showed significant attenuation in anxiety scores relative to the placebo group in the group treated with clonazepam during the speech phase, and in the clonazepam and CBD 300 mg groups in the post-speech phase. Clonazepam was more sedative than CBD 300 and 900 mg and induced a smaller increase in systolic and diastolic blood pressure than CBD 300 mg. The results confirmed that the acute administration of CBD induced anxiolytic effects with a dose-dependent inverted U-shaped curve in healthy subjects, since the subjective anxiety measures were reduced with CBD 300 mg, but not with CBD 100 and 900 mg, in the post-speech phase.