Effectiveness of Pilates-based exercises on the diastasis recti abdominis in climacteric women: a randomized controlled trial

Introduction: Recent studies have related the climacteric period with changes in connective tissue elasticity that may be related to diastasis recti abdominis. Mat Pilates is a method of exercise without impact that currently has more practitioners, due to its satisfactory results. However, there are no studies that evaluate the effectiveness of mat Pilates for women with diastasis recti abdominis. Objective: To evaluate the effectiveness of the mat Pilates program in climacteric women with diastasis recti abdominis. Methods: This randomized single-blinded clinical trial evaluated climacteric women with diastasis recti abdominis. The participants were randomized into the experimental group, which participated in 3 weekly sessions of mat Pilates for 12 weeks for a total of 36 sessions, and the control group (without exercises). The inter-rectus distance was measured with a digital caliper. The G*Power Version 3.1.9.2. software was used for the sample calculation, and the SPSS 20.0 program was used for statistical analysis. Results: The study comprised 21 women, including 10 in the control group and 11 in the experimental group, with mean ages of 54.3 ± 7.1 and 55.3 ± 6.0 years and body mass index values of 28.8 ± 5.5 kg/m2 and 29.9 ± 4.48 kg/m2, respectively. In the experimental group, reductions were observed in all the measures related to diastasis recti abdominis (p<0.05) in the supraumbilical, umbilical, and infra-umbilical regions. Conclusion: The mat Pilates method is effective for reducing diastasis recti abdominis in the climacteric period.

Efficiency of pulsed electromagnetic field and neuromuscular electrical stimulation on painful shoulder following stroke / Eficiência do campo eletromagnético pulsado e da estimulação elétrica neuromuscular em ombro doloroso após acidente vascular cerebral

INTRODUCTION: Shoulder pain after stroke, a complication with a prevalence of up to 16­84% usually occurs after 2­3 months and leads to patients withdrawing from rehabilitation programs, staying in the hospital longer, having less limb function and having a great negative impact on their quality of life. The aim of the present study was to determine the effect of PEMF and NMES in reducing shoulder pain in patients with stroke. MATERIAL AND METHODS: A prospective, randomized controlled trial included 51 patients with shoulder pain following stroke. The patients were randomly assigned to three groups (17 people in each group): Pulsed Electromagnetic Field (PEMF), Neuromuscular Electrical Stimulation (NMES) and Control group. The outcome measures were Visual Analogue Scale (VAS), Modified Ashworth Scale (MAS) and Fugl Meyer Assessment­Upper Extremity (FMA-UE), Active and Passive Range of Motion (AROM/PROM) assessed at the baseline, six weeks into the intervention, and one week into the follow-up. RESULTS: VAS score for pain showed a mean change of 1.60, 1.60 and 4.94 in PEMF, NMES, and control respectively after 20 sessions. It showed pain was significantly improved in all the groups (p<0.001), but the effectiveness of the PEMF and NMES groups was superior to the control group. CONCLUSION: The current literature showed that PEMF & NMES are effective in improving post-stroke shoulder pain, spasticity, range of motion and motor function and a novel method for stroke patients undergoing rehabilitation.

INTRODUÇÃO: Dor no ombro após acidente vascular cerebral com prevalência de 16­84% geralmente ocorre após 2­3 meses e pode resultar na suspensão de programas de reabilitação, internações hospitalares mais longas e redução da função dos membros, prejudicando qualidade de vida dos pacientes com AVC. O objetivo do presente estudo foi determinar o efeito da PEMF e da EENM na redução da dor no ombro em pacientes com acidente vascular cerebral. MATERIAL E MÉTODOS: Um estudo prospectivo, randomizado e controlado incluiu 51 pacientes com dor no ombro pós-AVC. Os pacientes foram divididos aleatoriamente em três grupos (17 pessoas em cada grupo): grupo Campo Eletromagnético Pulsado (PEMF), grupo Estimulação Elétrica Neuromuscular (EENM) e grupo Controle. As medidas de resultados foram na Escala Visual Analógica (VAS), Escala de Ashworth Modificada (MAS) e Avaliação de Fugl Meyer ­ Extremidade Superior (FMA-UE), Amplitude de Movimento (AROM/PROM) foram avaliadas no início do estudo, após seis semanas de tratamento, e após um acompanhamento semanal. RESULTADOS: A pontuação VAS para dor mostrada uma alteração média de 1,60, 1,60 e 4,94 na PEMF, EENM e Controle, respectivamente, após 20 sessões. Mostrou melhora significativa entre os três grupos (p<0,001), mas a eficácia do grupo PEMF e EENM foi superior ao grupo Controle. CONCLUSÃO: O presente estudo mostrou que PEMF e EENM são eficazes na melhora da dor no ombro pós-AVC, espasticidade, amplitude de movimento e função motora e um novo método para pacientes com AVC em reabilitação. Nossas descobertas indicam que a eficácia da EENM é claramente superior à do PEMF na manutenção da analgesia a longo prazo.

¿Ensayos clínicos de superioridad, equivalencia o no inferioridad?

La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.

Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.

Importancia del laboratorio en los ensayos clínicos

Los resultados de los exámenes que se realizan en el laboratorio clínico deben constituir una parte esencial en la evaluación de los sujetos incluidos en los ensayos clínicos para la introducción de nuevos medicamentos. En este artículo se describen los aspectos más importantes del trabajo en el laboratorio durante el desarrollo de un ensayo donde se emplean nuevas tecnologías. Los ensayos clínicos no solo mejoran los indicadores de salud de la población, sino que, además, exigen los mejores estándares de diagnóstico y evaluación del tratamiento, a través de nuevas tecnologías, donde se incluye el laboratorio clínico.

The results of the exams that are carried out in the clinical laboratory should constitute an essential part in the evaluation of people included in clinical trials for the introduction of new medications. In this article the most important aspects of work in the laboratory are described, during the development of a trial where new technologies are used. Clinical trials not only improve health indicators of the population, but also, demand the best diagnosis standards and evaluation of the treatment, through new technologies, where clinical laboratory is included.

Investigation and analysis of the current status of clinical research nurses / 中国临床药理学与治疗学

AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.

A Randomized，Double-blind，Multi-center Clinical Trial of Tengfu Jiangya Tablets Combined with Valsartan/Amlodipine in Treatment of Grade 2 Hypertension with Hyperactivity of Liver Yang / 中国实验方剂学杂志

ObjectiveTo observe the clinical efficacy and safety of Tengfu Jiangya tablets combined with valsartan/amlodipine in the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome. MethodAccording to a randomized，double-blind，and placebo parallel control method，288 patients with grade 2 hypertension with liver Yang hyperactivity from 7 subcenters were included. They were randomly divided into an observation group （144 cases） and a control group （144 cases），and then treated with Tengfu Jiangya tablets combined with valsartan/amlodipine and placebo combined with valsartan/amlodipine，respectively. The efficacy was evaluated after four weeks of intervention. During the experiment，the safety indicators and adverse reaction events of the subjects were recorded for safety evaluation，and the efficacy indicators and TCM syndrome scores were recorded for effectiveness evaluation. Sensitivity analysis was also conducted on the statistical results of the main efficacy indicators such as blood pressure （BP） compliance rate to ensure the accuracy of the analysis results. 88 groups of blood samples from each of the treatment and control groups were included as test subjects. Fasting blood samples were collected from the patients in the clinical trial on the day before and after medication，and enzyme linked immunosorbent assay （ELISA） was performed on the treated serum. The levels of arachidonic acid （AA），thromboxane B2 （TXB2），and prostaglandin E2 （PGE2） in the serum of the patients before and after treatment were measured to explore the regulation of inflammatory factors in the body by Tengfu Jiangya tablets. ResultA total of 271 patients （133 in the observation group and 138 in the control group） completed the trial. There was no statistically significant difference before and after treatment in such safety indicators as the blood routine （white blood cells，red blood cells，and platelets），urine routine （urinary protein and urinary red blood cells），alanine aminotransferase，aspartate aminotransferase，creatinine，urea，and abnormal electrocardiogram，and no serious adverse reactions were observed. After four weeks，the systolic blood pressure （SBP） difference and diastolic blood pressure （DBP） difference of patients in the observation group were greater than those in the control group（P<0.01）. According to the criteria for determining the antihypertensive effect，the overall response rate in the observation group［89.47%（119/133）］ was higher than that in the control group［57.97%（80/138）］ （Z=2.593，P<0.01）. The SBP compliance rate was 61.65%（82/133） and 37.68%（52/138） in the observation group and control group， respectively. The DBP compliance rate in the observation group was 78.20%（104/133），while in the control group it was 55.07%（76/138）. The overall BP compliance rate in the observation group was 48.12%（64/133），while in the control group it was 23.19%（32/138）. The BP compliance rates in the observation group were all significantly higher than those in the control group（χ2=15.571，16.236，18.404，P<0.01）. According to the criteria for evaluating the therapeutic effect of TCM syndrome integration，the overall response rate of the observation group［57.89%（77/133）］ was higher than that of the control group［38.41%（53/133）］ （Z=-3.172，P<0.01）.Compared with those before treatment， the levels of serum AA and TXB2 in the two groups were significantly decreased after treatment （P<0.01）， and the level of PGE2 in the observation group was significantly increased （P<0.01）. Compared with those of the control group after treatment， the levels of AA and TXB2 in the observation group were significantly decreased， while the level of PGE2 was significantly increased （P<0.01）. The results suggest that Tengfu Jiangya tablets can effectively reduce inflammatory factors，reduce the production of inflammatory mediators，and thus prevent the occurrence of inflammatory reactions in the treatment of patients with grade 2 hypertension. ConclusionTengfu Jiangya tablets can more effectively reduce patients' SBP and DBP，improve their BP compliance rates，and improve their TCM syndromes in the treatment of grade 2 hypertension with liver Yang hyperactivity. Its clinical application is safe. Tengfu Jiangya tablets has outstanding clinical efficacy and can be used as an effective intervention method for the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome.

Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19 / 中国医学伦理学

The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.

In-office dental bleaching in adolescents using 6% hydrogen peroxide with and without gingival barrier: a randomized double-blind clinical trial

Abstract At low concentrations used for in-office bleaching gels, such as 6% HP, gingival barrier continues to be performed. If we take into account that, in the at-home bleaching technique, no barrier is indicated, it seems that the use of a gingival barrier fails to make much sense when bleaching gel in low concentration is used for in-office bleaching. Objective This double-blind, split-mouth, randomized clinical trial evaluated the gingival irritation (GI) of in-office bleaching using 6% hydrogen peroxide (HP) with and without a gingival barrier in adolescents, as well as color change and the impact of oral condition on quality of life. Methodology Overall, 60 participants were randomized into which side would or would not receive the gingival barrier. In-office bleaching was performed for 50 minutes with 6% HP in three sessions. The absolute risk and intensity of GI were assessed with a visual analogue scale. Color change was assessed using a digital spectrophotometer and color guides. The impact of oral condition on quality of life was assessed using the Brazilian version of the Oral Health Impact Profile (α=0.05). Results The proportion of patients who presented GI for the "with barrier" group was 31.6% and for the "without barrier" group, 30% (p=1.0). There is an equivalence for the evaluated groups regarding GI intensity (p<0.01). Color change was detected with no statistical differences (p>0.29). There was a significant impact of oral condition on quality of life after bleaching (p<0.001). Conclusions The use or not of the gingival barrier for in-office bleaching with 6% HP was equivalent for GI, as well as for bleaching efficacy, with improvement in the impact of oral condition on quality of life.

Eficacia y seguridad del supositorio Proctokinasa® en el tratamiento de la enfermedad inflamatoria pélvica aguda

Introducción: La enfermedad inflamatoria pélvica aguda es una entidad frecuente en mujeres jóvenes en edad reproductiva, y constituye la causa principal de infertilidad. La búsqueda de un tratamiento antiinflamatorio eficaz y seguro que alivie el dolor, evite complicaciones y secuelas, es una prioridad para su tratamiento. Objetivo: Evaluar la eficacia y seguridad del tratamiento con Proctokinasa® en la enfermedad inflamatoria pélvica aguda grados I y II. Materiales y métodos: Se desarrolló un ensayo clínico, controlado, abierto, de enero de 2017 a enero de 2018, que incluyó 76 pacientes con diagnóstico de enfermedad inflamatoria pélvica aguda en la atención primaria de salud, quienes fueron asignadas aleatoriamente a dos grupos de tratamiento: grupo principal Proctokinasa®, que recibió una unidad/8 h por 2 días, y el grupo Piroxicam, un supositorio de 20 mg/24 h por 7 días. La antibioticoterapia oral recomendada se inició simultáneamente. Se evaluó la respuesta clínica y ecográfica al tratamiento. Los eventos adversos fueron evaluados. Resultados: Se constató respuesta clínica a partir de las 72 horas de tratamiento en más del 50 % de las pacientes en ambos grupos, y fue del 100 % de los casos para el grupo Proctokinasa® en las dos últimas evaluaciones realizadas (días 10 y 15). Se evidenció la remisión de las alteraciones ecográficas en el 96,9 % del grupo Proctokinasa®. Los eventos adversos fueron escasos y leves. Conclusiones: El empleo de Proctokinasa® resultó eficaz y seguro en el tratamiento de la enfermedad inflamatoria pélvica aguda grados I y II.

Introduction: Acute pelvic inflammatory disease is a common entity in young women of reproductive age and it is a leading cause of infertility. The search for an effective and safe anti-inflammatory treatment that relieves pain, avoids complications and sequels, it is priority for its treatment. Objective: To evaluate the efficacy and safety of the treatment with Proctokinasa® in acute pelvic inflammatory disease grades I and II. Materials and methods: An open, controlled clinical trial was carried out from January 2017 to January 2018 which included 76 patients diagnosed with acute pelvic inflammatory disease in primary health care; they were randomize assigned to two treatment groups: Proctokinasa® main group, who received one unity/8h for 2 days, and the Piroxican group, 1 suppository of 20 mg/24h per 7 days. The recommended oral antibiotic therapy was started simultaneously. Clinical and ultrasound response to treatment were evaluated. Adverse events were evaluated. Results: Clinical response was stated after 72 hours of treatment inmore than 50% of the patients in both groups, and it was 100% for the Proctokinasa® group in the last two evaluations (days 10 and 15). Remission of ultrasound alterations was evident in 96.9% of the Proctokinasa® group. Adverse events were few and mild. Conclusions: The use of Proctokinasa® was effective and safe in the treatment of acute pelvic inflammatory disease grades I and II.

Evaluation of the efficacy and safety of cannabidiol-rich cannabis extract in children with autism spectrum disorder: randomized, double-blind, and placebo-controlled clinical trial

Abstract Objective Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction and by restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa improve the quality of life of children with ASD without causing serious adverse effects, thus providing an alternative therapeutic option. The objective of this study was to evaluate the efficacy and safety of a cannabis extract rich in cannabidiol (CBD) in children with ASD. Methods In this randomized, double-blind, placebo-controlled clinical trial, 60 children, aged from 5 to 11 years, were selected and divided into two groups: the treatment group, which received the CBD-rich cannabis extract, and the control group, which received the placebo. They both used their respective products for a period of 12 weeks. Statistical analysis was done by two-factor mixed analysis of variance (two-way ANOVA). Results Significant results were found for social interaction (F1,116 = 14.13, p = 0.0002), anxiety (F1,116 = 5.99, p = 0.016), psychomotor agitation (F1,116 = 9.22, p = 0.003), number of meals a day (F1,116 = 4.11, p = 0.04), and concentration (F1,48 = 6.75, p = 0.01), the last of which was only significant in mild ASD cases. Regarding safety, it was found that only three children in the treatment group (9.7%) had adverse effects, namely dizziness, insomnia, colic, and weight gain. Conclusion CBD-rich cannabis extract was found to improve one of the diagnostic criteria for ASD (social interaction), as well as features that often co-exist with ASD, and to have few serious adverse effects.

Randomized crossover clinical trial of a Mindfulness-based intervention for nurse leaders: A pilot study / Ensayo clínico aleatorizado cruzado de una intervención basada en mindfulness con enfermeros líderes: estudio piloto / Ensaio clínico randomizado cruzado de uma intervenção baseada em mindfulness em enfermeiros líderes: estudo-piloto

Objective: to analyze the effects of a Mindfulness-based intervention on nurse leaders' emotional intelligence and resilience. Method: a pilot study of a randomized crossover clinical trial. The sample (n=32) was randomized into Group A (n=18) and Group B (n=14) and evaluated at the pre-test, post-test and follow-up moments. The outcomes were assessed using the Emotional Intelligence Measure, the Connor-Davidson Resilience Questionnaire and the Five Facet Mindfulness Questionnaire, and analyzed using Generalized Linear Mixed Models. Results: a total of 32 nurses with a mean age of 42.6 years old were evaluated. The analyses showed significant interactions between the effects of the group x moment factors on the Self-motivation (p=0.005), Sociability (p<0.001), Self-control (p=0.013), and Total (p=0.002) emotional intelligence skill scores; as well as on the Observe (p=0.042), Describe (p=0.008), Non-judgment (p<0.001), Act with awareness (p=0.004) and Total (p<0.001) mindfulness facets. Post-test: there was a statistically significant increase in the Sociability (p=0.009) and Self-control (p=0.015) emotional intelligence skills; as well as in the Non-judgment (p=0.022) and Total (p=0.002) mindfulness facets. Follow-up: a significant increase was observed in the Non-judgment (p=0.024) and Total (p=0.026) mindfulness facets. The "resilience" variable did not present statistical significance in the "group x moment" factor, both in the post-test and during follow-up. Conclusion: the Mindfulness-based intervention used proved to be effective in increasing nurse leaders' emotional intelligence and dispositional mindfulness skills. Brazilian Registry of Clinical Trials (RBR-3c62gy), registered on March 4 th , 2020, updated on September 16 th , 2022.

Objetivo: analizar los efectos de una intervención basada en mindfulness sobre la inteligencia emocional y la resiliencia de enfermeros líderes. Método: estudio piloto de un ensayo clínico aleatorizado cruzado. Muestra (n=32) aleatorizada en el grupo A (n=18) y grupo B (n=14), se los evaluó en el pretest, postest y seguimiento. Los resultados fueron evaluados mediante la Medida de Inteligencia Emocional, el Cuestionario de Resiliencia de Connor-Davidson y el Cuestionario Mindfulness de Cinco Facetas, y analizados por el Generalized Linear Mixed Models . Resultados: fueron evaluadas 32 enfermeras con una edad promedio de 42,6 años. Los análisis mostraron interacciones significativas de los efectos de los factores grupo vs. momento en los puntajes de las habilidades de automotivación (p=0,005), sociabilidad (p<0,001), autocontrol (p=0,013) y total (p=0,002) de inteligencia emocional; de las facetas observar (p=0,042), describir (p=0,008), no juzgar (p<0,001), actuar con conciencia (p=0,004) y total (p<0,001) de mindfulness. Postest: hubo un aumento estadísticamente significativo de las habilidades de sociabilidad (p=0,009) y autocontrol (p=0,015) de inteligencia emocional; de las facetas no juzgar (p=0,022) y total (p=0,002) de mindfulness . Seguimiento: se observó un aumento significativo en las facetas no juzgar (p=0,024) y total (p=0,026) de mindfulness . La variable resiliencia no presentó significación estadística en el factor grupo vs. momento en el postest y seguimiento. Conclusión: la intervención basada en mindfulness utilizada demostró ser eficaz para aumentar la inteligencia emocional y las habilidades de mindfulness disposicional de los enfermeros líderes. Registro Brasileño de Ensayos Clínicos (RBR-3c62gy), registrado el 4 de marzo de 2020, actualizado el 16 de septiembre de 2022.

Objetivo: analisar os efeitos de uma intervenção baseada em mindfulness na inteligência emocional e resiliência de enfermeiros líderes. Método: estudo-piloto de ensaio clínico randomizado cruzado. Amostra (n=32) randomizada em grupo A (n=18) e grupo B (n=14), avaliados nos momentos pré-teste, pós-teste e seguimento. Os desfechos foram avaliados pela Medida de Inteligência Emocional, pelo Questionário de Resiliência Connor-Davidson e pelo Questionário das Cinco Facetas de Mindfulness , e analisados pelo Generalized Linear Mixed Model . Resultados: foram avaliadas 32 enfermeiras com idade média de 42,6 anos. As análises mostraram interações significativas dos efeitos dos fatores Grupo x Momento nos escores das habilidades de automotivação (p=0,005), sociabilidade (p<0,001), autocontrole (p=0,013) e total (p=0,002) de inteligência emocional; das facetas observar (p=0,042), descrever (p=0,008), não julgar (p<0,001), agir com consciência (p=0,004) e total (p<0,001) de mindfulness . Pós-teste: houve aumento estatisticamente significante das habilidades de sociabilidade (p=0,009) e autocontrole (p=0,015) de inteligência emocional; das facetas não julgar (p=0,022) e total (p=0,002) de mindfulness . Seguimento: observou-se aumento significativo das facetas não julgar (p=0,024) e total (p=0,026) de mindfulness . A variável resiliência não apresentou significância estatística no fator Grupo x Momento, no pós-teste e seguimento. Conclusão: a intervenção baseada em mindfulness utilizada mostrou-se efetiva no aumento das habilidades de inteligência emocional e mindfulness disposicional de enfermeiros líderes. Registro Brasileiro de Ensaios Clínicos (RBR-3c62gy), registrado em 04 de março de 2020, atualizado em 16 de setembro de 2022.

Evaluación in vitro de la actividad antifúngica de extractos fluidos de Dichrostachys cinerea L. (marabú) frente a Candida albicans

Introducción: La Dichrostachys cinerea L. (marabú) es una planta que crece en Cuba, de la que se estudian propiedades medicinales. La resistencia de levaduras del género Candida a los antifúngicos sintéticos disponibles en la actualidad es cada vez mayor, por lo que se buscan nuevos compuestos de origen vegetal que puedan ser eficaces en el tratamiento de infecciones causadas por este germen. Objetivo: Evaluar la actividad antifúngica in vitro de Dichrostachys cinerea L. contra una cepa de Candida albicans. Métodos: Se realizó un estudio observacional analítico transversal in vitro para evaluar la actividad antifúngica de extractos fluidos de hojas y de tallos de D. cinerea L mediante el método de macrodilución en caldo y como sustancia de referencia el alcohol. Resultados: A través del proceso se mostró la actividad antifúngica del extracto fluido de tallos de D. cinerea L. al 50 % hasta la dilución 1/32, determinada como la concentración mínima inhibitoria; el extracto fluido de hojas al 30 % no logró inhibir el crecimiento de la cepa de Candida albicans ATCC 10231. Conclusiones: La actividad antifúngica del extracto fluido al 50 % de las hojas de Dichrostachys cinerea L. fue efectiva, no así el preparado farmacéutico al 30 %. Se determinó la concentración mínima inhibitoria del extracto fluido de hojas al 50 % y se demostró que ésta superó a la del alcohol al 50 % en tres diluciones contra la Candida albicans.

Introduction: Dichrostachys cinerea L. (marabou) is a plant that grows in Cuba, medicinal properties of this plant are being studied. The resistance of yeasts of the Candida genus to current available synthetic antifungals is increasingly greater. This is why, new compounds of plant origin are being searched for the effective treatment of infections caused by this germ. Objective: To evaluate the in vitro antifungal activity of Dichrostachys cinerea L against a strain of Candida albicans. Methods: An in vitro a cross-sectional analytic observational study was carried out to evaluate the antifungal activity of fluid extracts of D. cinerea L leaves and stems using the broth macro-dilution method and alcohol as the reference substance. Results: Through the process was shown the antifungal activity of the fluid extract of Dichrostachys cinerea L. stems at 50% up to the 1/32 dilution; it was determined as the minimum inhibitory concentration. The leaves fluid extract at 30% failed to inhibit the growth of the Candida albicans ATCC 10231 strain. Conclusions: The antifungal activity of the fluid extract at 50% of the leaves was effective, but not the pharmaceutical preparation at 30%. The minimum inhibitory concentration of the fluid extract of leaves at 50% was determined and it was shown that it exceeded that of alcohol at 50% in three dilutions against Candida albicans.

Educational video for self-care with arteriovenous fistula in renal patients: randomized clinical trial / Video educativo para el autocuidado de la fístula arteriovenosa en pacientes renales: ensayo clínico aleatorizado / Vídeo educacional para autocuidado com a fístula arteriovenosa de pacientes renais: ensaio clínico randomizado

Objective: to evaluate the effect of an educational video on the knowledge, attitude, and practice of self-care with arteriovenous fistula in patients undergoing hemodialysis treatment. Method: randomized controlled clinical trial, with two arms and single-blind. The intervention used an educational video on arteriovenous fistula self-care. The Fistula Self-Care Knowledge, Attitude, and Practice Scale was applied to 27 renal patients on hemodialysis in the control group and 28 in the intervention group at baseline, after seven and fourteen days. The data was analyzed using the Statistical Package for the Social Sciences software, using the chi-square test, Student's t-test, Mann-Whitney test, and Friedman's test with post-hoc analysis for multiple comparisons. Results: there were statistically significant differences in the knowledge and practice of self-care with the fistula at 0, 7 and, 14 days in the intervention (p= 0.004 and p<0.001, respectively) and control groups (p<0.001 for knowledge and practice). Attitude showed a significant difference at follow-up (p<0.001), but the post-hoc analysis did not confirm the significance obtained. Conclusion: patients' knowledge and practice showed significant increases at follow-up in the control and intervention groups, while the increase in attitude was not significant in either group. Clinical trial, registration number: U1111-1241-6730.

Objetivo: evaluar el efecto de un video educacional en el conocimiento, actitud y práctica del autocuidado de la fístula arteriovenosa de pacientes en tratamiento de hemodiálisis. Método: ensayo clínico aleatorio controlado, con dos brazos y simple ciego. La intervención utilizó un video educacional sobre el autocuidado de la fístula arteriovenosa. Fue aplicada la Escala de conocimiento, actitud y práctica del autocuidado de la fístula en 27 pacientes renales en hemodiálisis del grupo control y en 28 del grupo intervención en la línea de base, después de siete y catorce días. Los datos fueron analizados con el software Statistical Package for the Social Sciences , con la aplicación de las pruebas Chi-cuadrado, T de Student, Mann-Whitney y Test de Friedman, con análisis post-hoc para comparaciones múltiples. Resultados: se verificaron diferencias estadísticamente significativas en el conocimiento y práctica del autocuidado de la fístula en el seguimiento de 0, 7 y 14 días de los grupos intervención (p= 0,004 y p<0,001, respectivamente) y control (p<0,001 para el conocimiento y práctica). La actitud presentó diferencia significativa en el seguimiento (p<0,001), pero el análisis post-hoc no confirmó la significación obtenida. Conclusión: el conocimiento y práctica de los pacientes presentaron aumentos significantes en el seguimiento en los grupos control e intervención, en cuanto que el aumento de la actitud no fue significativo en ninguno de los grupos. Ensayo clínico, número de registro: U1111-1241-6730.

Objetivo: avaliar o efeito de um vídeo educacional no conhecimento, atitude e prática de autocuidado com a fístula arteriovenosa de pacientes em tratamento hemodialítico. Método: ensaio clínico randomizado controlado, com dois braços e unicego. A intervenção utilizou um vídeo educacional sobre o autocuidado com a fístula arteriovenosa. Foi aplicada a Escala de conhecimento, atitude e prática de autocuidado com a fístula em 27 pacientes renais em hemodiálise do grupo controle e 28 do grupo intervenção na linha de base, após sete e quatorze dias. Os dados foram analisados no software Statistical Package for the Social Sciences , com a aplicação dos testes qui-quadrado, T de Student, Mann-Whitney e Teste de Friedman com análise post-hoc para comparações múltiplas. Resultados: verificaram-se diferenças estatisticamente significantes no conhecimento e prática de autocuidado com a fístula no seguimento de 0, 7 e 14 dias dos grupos intervenção (p= 0,004 e p<0,001, respectivamente) e controle (p<0,001 para o conhecimento e prática). A atitude apresentou diferença significativa no seguimento (p<0,001), mas a análise post-hoc não confirmou a significância obtida. Conclusão: o conhecimento e prática dos pacientes apresentaram aumentos significativos no seguimento nos grupos controle e intervenção, enquanto o aumento da atitude não foi significativo em nenhum dos grupos. Ensaio clínico, número de registro: U1111-1241-6730.

Methodological Quality of Systematic Reviews Addressing Orthodontic Interventions: Methodological Study

ABSTRACT Objective: To assess the methodological quality and characteristics of systematic reviews (SRs) of interventional studies in orthodontics and assess how the certainty of the evidence is reported using the GRADE approach. Material and Methods: Six electronic databases were searched, followed by a hand search of the reference lists of eligible studies (PROSPERO #CRD42020180852). The required study design was randomized and nonrandomized studies of interventions published between January 2019 and May 2020. The Assessing the Methodological Quality of Systematic Reviews (AMSTAR 2) tool was used for the quality appraisal of the included SRs. Paired reviewers independently screened the studies, extracted data, and appraised the methodological quality. Results: The study included 46 SRs; 19.5% had moderate to high methodological quality, and the remaining had low to critically low methodological quality. Fifty-four percent of the reviews assessed the certainty of evidence using the GRADE approach, and 34.8% followed all GRADE criteria. Conclusion: Most reviews had a good judgment of the AMSTAR2 items, although some critical items contributed to decreased overall quality. Half of the reviews used the GRADE approach to assess the certainty of the evidence, and this approach should be included in future systematic reviews of interventions.

Colostrum immunotherapy and length of hospital stay in preterm infants: an intervention study / Imunoterapia de colostro e tempo de internamento de prematuros: estudo de intervenção

Abstract Objectives: to evaluate the effect of oropharyngeal colostrum immunotherapy on the length of hospital stay in preterm newborns with very low birth weight. Methods: interventional ambispective study, which consisted of eight daily administrations of 0.2 ml (four drops) of colostrum, totaling up to 56 syringes (for up to seven days). The control was historic. The main independent variable: length of hospital stay (days). Survival analysis was performed using the Kaplan-Meier Method and the survival effect was estimated - Log Rank Test (Mantel-Cox) and Breslow Test (Generalized Wilcoxon). A significance level of 5% was adopted. Results: of the 109 mother/child pairs, 56 were part of the treatment and 53 were part of the control group. There was no association between oropharyngeal colostrum immunotherapy and length of stay for preterm newborns with very low birth weight in the general sample. However, after stratification, a shorter hospital stay (42 versus 51 days, HR= 1.78, CI95%=1.02-3.09, p=0.04) was demonstrated among premature infants with ≥28 gestational weeks undergoing oropharyngeal colostrum immunotherapy. Conclusions: we found an association between oropharyngeal colostrum immunotherapy and shorter median length of hospital stay in the subgroup of premature infants ≥ 28 weeks of gestational age, but we did not find significant differences in those <28 weeks.

Resumo Objetivos: avaliar o efeito da imunoterapia orofaríngea de colostro no tempo de internamento hospitalar de recém-nascidos pré-termos de muito baixo peso. Métodos: estudo de intervenção, ambispectivo, que consistiu em oito administrações diárias de 0,2 ml (quatro gotas) de colostro, totalizando até 56 seringas (por até sete dias). O controle foi histórico. A variável independente principal: tempo de permanência hospitalar (dias). Realizada análise de sobrevivência pelo Método de Kaplan-Meier e estimado o efeito da sobrevida - Teste de Log Rank (Mantel-Cox) e Teste de Breslow (Wilcoxon Generalizado). Adotou-se o nível de significância de 5%. Resultados: das 109 duplas mães/filho, 56 fizeram parte da análise do grupo tratamento e 53 do controle. Não houve associação entre imunoterapia orofaríngea de colostro e tempo de internamento de recém-nascidos pré-termos de muito baixo peso na amostra geral. Após estratificação demonstrou-se menor tempo de permanência hospitalar (43 versus 51 dias, HR=1,78, IC95%= 1,02-3,09, p=0,04) entre os prematuros com ≥28 semanas gestacionais submetidos a imunoterapia orofaríngea de colostro. Conclusões: encontrou-se associação entre imunoterapia orofaríngea de colostro e menor mediana de tempo de internamento hospitalar no subgrupo de prematuros ≥ 28 semanas de idade gestacional, porém não foram encontradas diferenças significativas naqueles < 28 semanas.

Oropharyngeal colostrum immunotherapy and risk reduction of mortality in very low birth weight premature newborns: a clinical trial

Abstract Objective To evaluate the effect of oropharyngeal colostrum immunotherapy (OCI) on the mortality of preterm newborns (PTNB) with very low birth weight (VLBW). Method Non-randomized clinical trial, carried out with 138 mother-child pairs attended at a public maternity hospital. The treatment group used raw colostrum, dripping 4 drops (0.2 ml) into the oropharyngeal mucosa, totaling 8 administrations in 24 h, up to the 7th complete day of life (OCI). The control group was composed of newborns admitted to the same maternity hospital before the implementation of the OCI. Analyzes were performed: descriptive, bivariate, multiple logistic regression, and survival analysis, with a significance level of 5% and 95% CI. Results The treatment group had an RR of death of 0.26 (95% CI = 0.07-0.67; p= 0.00), adjusted for maternal age, marital status, gestational hypertension, type of delivery, number of prenatal visits, and birth weight. Number Needed to Treat (NNT) demonstrated that for every 5 individuals treated with OCI, one death was prevented NNT = 4.9 (95% CI = 1.84-5.20); however, for PTNB with VLBW who remained hospitalized for 50, 100 and 150 days, the NNT reduces to 4, 4 and 3, respectively. Conclusion The OCI proved to be a beneficial intervention, since it reduced the risk of mortality in PTNB with VLBW when compared to the control group.

What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Intervención digital basada en la atención plena para estrés y ansiedad generalizada en trabajadores universitarios / Digital intervention based on mindfulness for stress and generalized anxiety in university workers

Resumen Objetivo: Analizar el efecto y la percepción de una intervención digital, basada en atención plena para disminuir el estrés y ansiedad generalizada entre los trabajadores de la Universidad Veracruzana (UV). Materiales y Métodos: Un ensayo clínico aleatorizado se llevó a cabo con 102 participantes, divididos en un grupo experimental y un grupo control para evaluar el efecto de una intervención a través de WhatsApp, en la reducción del estrés y la ansiedad. El grupo experimental recibió un programa de meditación con el fin de capacitarlos y enseñarles a practicar la atención plena. Se utilizaron las escalas de estrés percibido PSS-10 y del trastorno de la ansiedad generalizada GAD-7 para evaluar el efecto de la intervención. Los participantes expresaron su opinión sobre la intervención mediante entrevistas focalizadas con preguntas estandarizadas. Resultados: Se encuentra una disminución en las medianas del nivel de estrés percibido y ansiedad generalizada del grupo experimental entre el momento pre-intervención y post-intervención, con una diferencia estadísticamente significativa, p=0.012 y p=0.013, respectivamente. En el grupo control se visualiza un ligero aumento en dichos niveles y no se identifican diferencias significativas entre la medición basal y final, tanto en estrés como en ansiedad. En el análisis del espectro del discurso, se examinó la categoría de "Usabilidad" y se identificaron diferentes aspectos relacionados con la percepción, participación y recomendación de la intervención. Conclusiones: Se encontró una mejoría estadísticamente significativa en los niveles de estrés y ansiedad generalizada. Se demuestra que, realizar intervenciones en salud pública que involucren la tecnología, es cada vez más adaptable y contribuye al avance del conocimiento dentro del autocuidado de la salud mental entre los trabajadores de la Universidad Veracruzana.

Abstract Objective: To analyze the effect and perception of a digital intervention, based on mindfulness to reduce stress and generalized anxiety among workers at the Universidad Veracruzana (UV). Materials and Methods: A randomized clinical trial was carried out with 102 participants, divided into an experimental group and a control group to evaluate the effect of an intervention through WhatsApp in reducing stress and anxiety. The experimental group received a meditation program in order to train and teach them to practice mindfulness. The PSS-10 Perceived Stress and GAD-7 Generalized Anxiety Disorder scales were used to assess the effect of the intervention. Participants expressed their opinion about the intervention through focused interviews with standardized questions. Results: There is a decrease in the median level of perceived stress and generalized anxiety of the experimental group between the pre-intervention and post-intervention moments, with a statistically significant difference, p=0.012 and p=0.013, respectively. In the control group, a slight increase in said levels was observed and no significant differences were identified between the baseline and final measurement, both in stress and anxiety. In the discourse spectrum analysis, the "Usability" category was examined and different aspects related to the perception, participation and recommendation of the intervention were identified. Conclusions: A statistically significant improvement was found in the levels of stress and generalized anxiety. It is shown that carrying out public health interventions that involve technology is increasingly adaptable and contributes to the advancement of knowledge within mental health self-care among workers at the Universidad Veracruzana.

Risk of bias assessment of clinical trials referenced in the technical notes on direct-acting oral anticoagulants available on e-NatJus / Avaliação do risco de viés dos ensaios clínicos referenciados nas notas técnicas sobre os anticoagulantes orais diretos disponíveis no e-NatJus

Objective: Assess and classify the risks of bias in the clinical trials (CTs) that make up the technical notes (TNs) referring to direct-acting oral anticoagulants (DOAC) requests. Methods: The TNs related to the DOAC requests of apixaban, dabigatran, edoxaban, and rivaroxaban were selected on the e-NatJus website and, after excluding duplicate references, an analysis of the CT used for their writing was carried out. The CT risk of bias (low, high, or uncertain bias) was assessed using the Cochrane Risk of Bias tool, and the results were added to Review Manager 5.4. Results: 181 TNs were selected, 236 articles were analyzed and after applying the inclusion criteria, 28 CTs were analyzed in full. None of the CTs were free of bias. Most CTs, 71% (20/28), had a low risk of bias regarding attrition bias and reporting bias. In contrast, 61% (17/28) of the studies did not control for selection, performance, and detection bias, as they present uncertainties and a high risk of bias. In addition, it was observed that 21% (6/28) of the CTs had a high risk of bias for conflict of interest. Conclusion: The biases present in the CT cited as a reference for the TN referring to the DOAC request are significant and compromise their quality (AU).

Objetivo: Avaliar e classificar os riscos de vieses dos ensaios clínicos (EC) que compõem as NTs referentes à solicitação dos DOAC. Métodos: As NTs relacionadas à solicitação dos DOAC apixabana, dabigatrana, edoxabana e rivaroxabana foram selecionadas no website e-NatJus e, após exclusão das referências duplicadas, foi realizada uma análise dos EC utilizados para a redação das mesmas. O risco de viés dos EC (baixo, alto ou viés incerto) foi avaliado utilizando a ferramenta Cochrane Risk of Bias e os resultados foram adicionados no Review Manager 5.4. Resultados: Foram selecionadas 181 NTs, analisados 236 artigos e após aplicação dos critérios de inclusão, resultou em 28 EC analisados na íntegra. Nenhum dos EC ficou isento de viés. A maioria dos EC, 71% (20/28), apresentou baixo risco de viés em relação ao viés de atrito e viés de relato. Por outro lado, 61% (17/28) dos estudos não controlaram o viés de seleção, performance e detecção, uma vez que apresentam incertezas e alto risco de viés. Além disso, foi observado que 21% (6/28) dos EC apresentaram alto risco de viés para conflito de interesses. Conclusão: Os vieses presentes nos EC citados como referência das NT referentes a solicitação dos DOAC são significativos e comprometem a sua qualidade (AU).

Effect of upper lip compression on pain reduction during local anesthesia. A split-mouth randomized clinical trial

Objectives: To evaluate the effect of pressure on the skin of upper lip in decreasing pain perception during a local maxillary anesthetic injection. Material and Methods: A split-mouth crossover randomized clinical trial was designed. Seventy-one volunteer students (23.6±1.9 years old, 53.5% women) were selected. A group chosen at random had their left or right side of upper lip compressed by a wooden clothes peg as the compression instrument and 0.6 ml of lidocaine 2% with epinephrine 1:100,000 was administered at the buccal apex level of the lateral incisors tooth. Two weeks later anesthesia was administered on the opposite side of the lip according to the randomization recorded. The intensity of perceived pain level between the two injections using a 100 mm visual analog scale (VAS) and co-variable effect were compared (Wilcoxon test p < 0.05, RStudio). Results: The average of the perceived pain with and without upper lip compression was 27.6±14.5 mm (range 0-80 mm) and 36.33±17.9 mm (range 10-90 mm) respectively (p= 0.002). No significant differences were recorded according the covariance analysis with the sex (p = 0.55) and age (p = 0.89). Conclusion: The upper lip compression significantly reduces the perception of pain during a local maxillary anesthetic technique.