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The pathogenesis of senile frailty syndrome is not yet clear, and there is no recommended drug treatment. Therefore, finding effective medications and improving clinical efficacy are the issues causing main delays and difficulties in furthering our understanding and treatment of this condition. A randomized double-blind placebo-controlled study will be conducted. A total of 60 eligible patients with senile frailty syndrome will be enrolled and randomly assigned to one of two groups: a control group and an experimental group. After 12 weeks of intervention and a 1-month follow-up period, the efficacy and safety of Jiawei Huan Shao Dan (JWHSD) in the patients will be observed and their degrees of weakness and cognitive function evaluated. If the present trial is successful, it will provide patients and doctors with a new, more effective method of alleviating senile frailty syndrome.

La patogenia del síndrome de fragilidad senil aún no está clara, y no existe un tratamiento farmacológico recomendado. Por lo tanto, encontrar medicamentos efectivos y mejorar la eficacia clínica son los problemas que causan principales retrasos y dificultades en la comprensión y tratamiento de esta condición. Se llevará a cabo un estudio aleatorio doble ciego controlado con placebo. Un total de 60 pacientes elegibles con síndrome de fragilidad senil serán reclutados y asignados aleatoriamente a uno de dos grupos: un grupo de control y un grupo experimental. Después de 12 semanas de intervención y unperíodo de seguimiento de 1 mes, se observarán la eficacia y seguridad de Jiawei Huan Shao Dan (JWHSD) en los pacientes, así como sus grados de debilidad y función cognitiva. Si el presente ensayo tiene éxito, proporcionará a pacientes y médicos un nuevo método más efectivo para aliviar el síndrome de fragilidad senil.

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There is little evidence on the effectiveness of psychotherapeutic interventions in reducing new suicide attempts. This article aims to evaluate the effectiveness of psychotherapeutic interventions in reducing suicide attempts among patients with a history of previous attempts. We selected 17 articles from four databases: PubMed, Cochrane, APA PsycInfo and LILACS, in 2023. Six studies showed statistical differences that favored psychotherapeutic intervention at some point during the follow-up period. These psychotherapies addressed: problem-solving, hope induction, skills training. When comparing psychotherapy with usual care, a meta-analysis revealed an odds ratio of 0.41 (95 % CI, 0.17-0.99, p = .05) in the analysis up to 12 months of follow-up, and an odds ratio of 0.48 (95 % CI, 0.30-0.78, p < .001) after 12 months of follow-up. The results indicate the efficacy of these interventions in reducing additional suicide attempts, but they should be analyzed with caution, given the heterogeneity of the sample, treatments, and comparators. This review supports the development of prevention strategies indicated for patients who have attempted suicide.

Hay poca evidencia sobre la eficacia de las psicoterapias para reducir los nuevos intentos de suicidio. Este artículo tiene como objetivo evaluar la efectividad de las intervenciones psicoterapéuticas en la reducción de los intentos de suicidio entre pacientes con intentos previos. Se seleccionaron 17 artículos de cuatro bases de datos: PubMed, Cochrane, APA PsycInfo y LILACS. Seis estudios mostraron diferencias estadísticas que favorecieron la intervención psicoterapéutica en algún momento durante el período de seguimiento. Estas psicoterapias abordaron: resolución de problemas, inducción de esperanza y entrenamiento de habilidades. Al comparar la psicoterapia con el tratamiento habitual, el metanálisis reveló un odds ratio de 0.41 (IC del 95 %, 0.17 a 0.99, p = .05) en el análisis hasta los 12 meses de seguimiento, y un odds ratio de 0.48 (IC del 95 %, 0.30 a 0.78, p < .001) después de 12 meses de seguimiento. Los resultados apuntan a la eficacia de estas intervenciones para reducir los intentos de suicidio adicionales, pero deben analizarse con cautela, dada la heterogeneidad de la muestra, los tratamientos y los comparadores. Esta revisión apoya el desarrollo de estrategias de prevención indicadas para pacientes que han intentado suicidarse.

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Background: Clinical trials aim to improve health care by reducing treatment costs, enhancing quality, and advancing the discovery of safe treatments. Notably, limited knowledge among resident doctors may impact research quality. Aims and Objectives: The study seeks to evaluate awareness and knowledge of clinical trials among undergraduate, intern, and postgraduate medical students. Materials and Methods: It was an observational, cross-sectional study conducted on 300 medical students over 3 months after approval from the Institutional Ethics Committee (IEC). The pre-validated questionnaire containing 24 items was administered through email, WhatsApp, or in person. Data were analyzed using descriptive statistics. Results: In the study, 96.7% of participants believe the necessity of clinical trials. Notably, 72% of undergraduates and 76% of postgraduates express willingness to participate in a clinical trial. Furthermore, 93% of participants view trials as vital for innovative therapies, and 74.3% believe that they enhance health-care services. Knowledge gaps in clinical trials were evident: 56.3% of participants knew good clinical practice guidelines, 46.7% of participants were aware of them, and only 12.3% of participants knew the IEC role. However, 66.7% of participants recognized the Drug Controller General of India (DCGI) and IEC approvals as crucial for trials, and 53.7% of participants identified DCGI as the regulatory authority. 68.3% of participants could not define a placebo-controlled trial. However, 75% of participants were aware of the consequences of informed consent form non-compliance. Most knew about post-marketing surveillance (80.33%), but awareness of healthy volunteer involvement in Phase 1 was lower (48%). In addition, 62.33% of participants knew about marketing access after Phase 3, and 60% of participants were aware of adverse effects reporting procedures. Conclusion: The study reveals a concerning lack of awareness regarding clinical trials among undergraduate, intern, and postgraduate medical students, emphasizing the need for targeted educational interventions in medical curricula.

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Inborn errors of metabolism (IEM) are a rare and complex group of inherited disorders, typically observed in infants as autosomal recessive or, less commonly, as X-linked recessive conditions. Newborn screening (NBS) for IEMs can significantly improve prognosis and quality of life through early diagnosis and intervention, marking a significant public health achievement. NBS programs vary by country, but generally include tests for a range of metabolic errors, endocrine disorders, primary immunodeficiency disorders, congenital deafness, congenital heart defects, and cystic fibrosis. Integrating mass spectrometry (MS/MS), genetic sequencing, and emerging technologies such as next-generation sequencing into NBS programs represents a substantial advancement in the field of healthcare. These technologies enable early detection, intervention, and the possibility of personalized treatments through gene therapies. Such advancements are poised to shape the future of NBS, potentially enhancing healthcare outcomes for newborns on a global scale. Neonatal screening is the most well-known and widely implemented proactive and preventative pediatric public health initiative worldwide. It encompasses a comprehensive education system, screening, diagnostic confirmation, management, follow-up, and counseling. This article reviews recent advances in newborn metabolic screening, drawing on the results of various clinical trials and pilot studies.

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Introduction: Shivering is a common complication during neuraxial anesthesia, leading to metabolic and cardiovascular challenges. Existing treatments vary in effectiveness, and this study compares intravenous tramadol and nalbuphine, both administered with midazolam, for shivering control. Objectives: To evaluate and compare the efficacy of IV tramadol and IV nalbuphine, alongside midazolam, in controlling post-spinal anesthesia shivering. Materials and Methods: A prospective, randomized comparative clinical study involving 100 patients undergoing various surgical procedures under spinal anesthesia. Patients were divided into two groups to receive either IV Tramadol or IV Nalbuphine with midazolam. Parameters like shivering severity, time to cessation, recurrence, and side effects were recorded and analyzed. Results: Both tramadol and nalbuphine effectively controlled shivering with comparable response times and side effect profiles. There was no significant difference in the incidence of nausea, vomiting, and sedation between the groups. Hemodynamic stability was maintained throughout the study. Conclusion: IV tramadol and IV nalbuphine, in conjunction with midazolam, are effective in controlling post-spinal anesthesia shivering, with similar efficacy and safety profiles. They provide valuable options for clinicians in managing this common anesthetic complication. Further research is encouraged for more refined application in diverse patient populations.

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Treatment of hyperuricemia with allopurinol and Febuxotate has been shown to be effective in hypertensive patients. Studies comparing the effects of both drugs in hypertensive patients were very limited, especially in the Vietnam population. Evaluating the treatment outcome of febuxostat when compared with allopurinol in hyperuricemia patients with hypertension in Vietnam. We conducted a randomized controlled clinical trial with an allocation ratio of 1:2 on 108 hyperuricemia outpatients with hypertension ?40 years old. Group A was treated with allopurinol 100 mg, increased to 300 mg if treatment results were not achieved. Group B used febuxostat 40 mg, which increased to 80 mg. The endpoint was to control serum uric acid levels <6.0 mg/dl (<360 ?mol/l). Primary outcomes were re-evaluated after 4 and 8 weeks, comparing the reaching endpoint proportion between the two groups. The secondary outcomes were subgroup analysis on characteristic groups of age, gender, and serum lipid indices such as non-HDL-c and triglyceride (TG)/non-HDL-c ratio to evaluate the impact on treatment outcomes within and between two groups. The primary outcomes evaluating the effectiveness between the two regimens showed that the uric acid concentrations after 4 weeks in groups A and B were 343.5 ± 104.0 and 378.0 ± 90.0 µmol/l, respectively (p = 0.008), after 8 weeks it was 268.0 ± 97.8 and 310.0 ± 52.8 µmol/l (p < 0.001). After 8 weeks of intervention, the reaching endpoint proportion in the A and B groups was 91.7% and 97.1%, respectively [risk ratio (RR) = 1.06, 95% confidence interval (CI) 0.97–1.16, p = 0.297]. The secondary outcome was analized subgroup showed that there was a statistically significant difference when comparing group A and group B at age <60 (p = 0.020), male gender (p = 0.021), non-HDL ? 3.37 (p = 0.042), TG/HDL-c < 4.5 (p = 0.006), in which the allopurinol group showed more optimal serum uric acid lowering results. Both regimens had good outcomes in the ability to reduce serum uric acid and a high proportion of reaching endpoints. Therefore, it could be applied in the clinical of treating hyperuricemia patients with hypertension in Vietnam. When analyzed between the two groups, there was no large difference in treatment outcomes between the two regimens, so preference among the two regimens was not necessary.

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Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other. Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity. Trial Registration Number: 2021-A02773-38.

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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.

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ABSTRACT Background: Immunomodulatory drugs and immunotherapies are being evaluated in clinical trials for the treatment of neuroinflammation, as the latter is an essential mechanism for the development and progression of Parkinson´s disease. Objective: The objective of the study is to review recent evidence on the evaluation of immunomodulators in randomized controlled clinical trials measuring improvement of motor symptoms. Methods: A meta-analysis of Movement Disorder Society-Unified Parkinson´s disease Rating Scale (MDS-UPDRS III) scores extracted from seven articles selected after an online search of PubMed, Cochrane Library, and Clarivate's Web of Science for randomized controlled clinical trials published between 2000 and July 2023 was performed. The selected articles reported clinical trials evaluating the effects of specific immunomodulators or treatments with known effects on the immune system and inflammation. MDS-UPDRS III scores were reported in these studies, and the results of the placebo groups were compared with those of the treatment groups. Results: A total of 590 patients treated with immunomodulators and 622 patients treated with placebo were included. A test for heterogeneity yielded an I2 value > 50%. The mean standard difference for change in MDS-UPDR III score was −0.46 (CI [95%] = −0.90 - −0.02, p < 0.01). No significant differences were found in the change in mean MDS-UPDR III score between the treatment and placebo groups; however, two studies showed a trend toward separation from the mean. Conclusion: The immunomodulatory treatments included in this study showed no efficacy in improving motor symptoms in Parkinson´s disease patients. Further clinical trials with larger patient populations are needed.

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Introduction: Spasticity is a pervasive and debilitating condition. Anti-spastic medications like Baclofen and Diazepam are most commonly used for spasticity management. Objectives: The study aimed to evaluate and compare the efficacy of Baclofen with that of Diazepam in the management of spasticity following acquired spinal cord injuries. Methods: In this randomised open-label study involving 60 patients, 30 patients received 5 mg of oral Baclofen thrice daily and 30 patients received 5 mg of oral Diazepam thrice daily for the management of spasticity. The extent of spasticity was measured by Modified Ashworth Scale (MAS). The efficacy of these drugs was measured with the mean improvement in the above parameters on days 7, 14, 28, 56 and 90 from the start of pharmacotherapy. Results: Baseline muscle spasticity scores were comparable. At the endpoint, mean improvement in tone of right and le? hip flexors (1.43 vs. 0.87), hip adductors (1.30 vs. 0.87), knee flexors (0.80 vs. 0.37), ankle plantar flexors (0.80 vs. 0.37) and ankle dorsiflexors (1.23 vs. 0.93) were significantly higher in Baclofen group (p<0.05), while the tone of right and le? hip abductors, hip and knee extensors showed no significant difference among the groups. Conclusion: Baclofen was found to be superior to Diazepam in terms of efficacy, especially for flexor spasticity of lower limbs in acquired spinal cord injuries.

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Abstract Introduction: The Kangaroo Baby Massage (KBM) is a technique designed for preterm and low birth weight newborns that eliminates the need for an incubator, providing a practical and beneficial option for mothers at home. Objective: To test the effect of the KBM on perceived maternal self-efficacy favoring the mother-infant interaction at home. Materials and methods: A pragmatic, double-blind, randomized clinical trial was conducted in three phases: 1) KBM integration with Kathryn Barnard's theory, 2) study design, and 3) implementation and outcome evaluation. Two groups were defined: The intervention group (KBM) and the control group (which used the kangaroo position without massage), each group consisted of 34 mother-infant pairs. Recruitment took place within an outpatient kangaroo program in Bogota, Colombia. Implementation and follow-up were conducted via teleconsultation, using the KBM video "Diary of My Kangaroo Baby" and simulators. The perceived maternal self-efficacy questionnaire was conducted at three points in time: prior to the study and on the 7th and 14th day after the study. The questionnaire was analyzed with a statistical design of longitudinal data in F1LDF1 factorial experiments. Results: Homogeneous groups were defined based on sociodemographic variables and maternal-perinatal history. Mothers who applied the KBM technique showed higher scores in perceived maternal self-efficacy at both 7 and 14 days compared to the control group mothers [RTE (lower limit; upper limit) - day 7: control = 0.502 (0.437; 0.567) vs. KBM = 0.503 (0.426; 0.581), and day 14: control = 0.564 (0.482; 0.640) vs. KBM = 0.719 (0.650; 0.776)]. Conclusion: The KBM is a nursing intervention that enhances perceived maternal self-efficacy, fostering greater family involvement and strengthening mother-child interaction.

Resumen Introducción: El masaje al bebé canguro (MBC) es una técnica para recién nacidos pretérmino y bajo peso al nacer que no requiere incubadora y favorece a las madres en el hogar. Objetivo: Probar el efecto del MBC sobre la autoeficacia materna percibida para favorecer la interacción madre-hijo en el hogar. Materiales y métodos: Ensayo clínico aleatorizado pragmático, doble ciego, desarrollado en tres fases: 1) integración MBC y teoría de Kathryn Barnard, 2) diseño del estudio y 3) ejecución y resultados. Se definieron dos grupos: intervención (MBC) y control (posición canguro sin masaje), con 34 diadas madre-hijo en cada grupo. Reclutamiento realizado en un programa canguro ambulatorio de Bogotá, Colombia. La ejecución y el seguimiento fue hecha a través de teleconsulta, el video MBC "Diario de mi bebé canguro" y simuladores. Se aplicó el cuestionario de autoeficacia materna percibida en tres momentos: antes de iniciar el estudio y a los días 7 y 14 después del estudio. Se analizó con un diseño estadístico de datos longitudinales en experimentos factoriales F1LDF1. Resultados: Fueron definidos grupos homogéneos en las variables sociodemográficas y de antecedentes materno-perinatales. Las madres que aplicaron el MBC registraron puntajes más altos de autoeficacia materna percibida a los 7 y 14 días, en comparación con las madres del control [RTE (límite inferior; límite superior) - día 7: control = 0.502 (0.437; 0.567) vs. MBC = 0.503 (0.426; 0.581), y día 14: control = 0.564 (0.482; 0.640) vs. MBC = 0.719 (0.650; 0.776)]. Conclusión: El MBC es una intervención de enfermería que mejoró la autoeficacia materna percibida, favoreciendo la participación de la familia y la interacción madre-hijo.

Resumo Introdução: A massagem no bebê canguru (MBC) é uma técnica para bebês prematuros e de baixo peso que não necessita de incubadora e que dá apoio às mães no domicílio. Objetivo: Testar o efeito da MBC na autoeficácia materna percebida para apoiar a interação mãe-bebê em casa. Materiais e método: Ensaio clínico randomizado, pragmático, duplo-cego, desenvolvido em três fases: i) integração da MBC e da teoria de Kathryn Barnard, ii) desenho do estudo e iii) execução e resultados. Foram definidos dois grupos: intervenção (MBC) e controle (posição canguru sem massagem), com 34 díades mãe-bebê em cada grupo. O recrutamento foi realizado em um programa canguru ambulatorial em Bogotá, Colômbia. A implementação e o acompanhamento foram feitos por meio de teleconsultas, do vídeo MBC "Diário do meu bebê canguru" e de simuladores. O questionário de autoeficácia materna percebida foi aplicado em três momentos: antes do início do estudo e nos dias 7 e 14 após o estudo. Ele foi analisado com um projeto estatístico de dados longitudinais em experimentos fatoriais F1LDF1. Resultados: Foram definidos grupos homogêneos para variáveis sociodemográficas e histórico ma-terno-perinatal. As mães que aplicaram o MBC registraram pontuações mais altas de autoeficácia materna percebida aos 7 e 14 dias, em comparação com as mães do controle [RTE (limite inferior; limite superior) - dia 7: controle = 0,502 (0,437; 0,567) vs. MBC = 0,503 (0,426; 0,581), e dia 14: controle = 0,564 (0,482; 0,640) vs. MBC = 0,719 (0,650; 0,776)]. Conclusões: a MBC é uma intervenção de enfermagem que melhorou a autoeficácia materna percebida, favorecendo o envolvimento familiar e a interação entre mãe e filho.

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Objective: The aim of the study was to compare the efficacy of Clevira tablets in Human adult patients, with Influenza A&B and Vital flu. Methods: This study was an open label, balanced, randomized, multi-dose, two-treatment, parallel, and comparative Phase III clinical trial to determine the safety and efficacy of Clevira Tablets. Twenty patients were enrolled and received Clevira Tablet along with Standard Treatment for Influenza A&B and other respiratory viral infections. Enrollment was based on the diagnosis of hematology, biochemistry, serology, RT-PCR, and chest X-ray and inclusion, and none of the exclusion criteria and included in the study. Results: All the patients demonstrated safety measures with respect to blood pressure and pulse rate. Furthermore, statistically significant (P < 0.0001) improvement showed in temperature from baseline (102.03 ± 0.64) and at the end of the study period (98.14 ± 0.70). Conclusion: The study demonstrated an expedited clinical cure with normal vital signs and hematological results which validated that Clevira is safe and efficacious in patients with Influenza A&B and Viral flu. The data further entrusted that Clevira can be used in infected patients with Influeza A&B and Viral Flu, and relieve the signs and symptoms, with a rapid recovery, without any adverse side effects.

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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.

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INTRODUCTION: Chronic non-specific low back pain (CNSLBP) is a major worldwide condition that has severe emotional, social, and economic consequences. Management is difficult, requiring the development of new, effective, and safe approaches. OBJECTIVES: This study was conducted to examine the effects of Pulsed Electromagnetic Fields (PEMF) and retrowalking on pain, disability, spinal mobility, hamstring tightness, balance, and kinesiophobia in patients with chronic non-specific low back pain. MATERIALS AND METHODS: Participants (n = 48) with CNSLBP were randomised into four groups; Group A: Conventional group, Group B: PEMF group, Group C: retrowalking group, and Group D: PEMF and retrowalking group. The interventions were given three times per week for six weeks. The outcomes were pain, disability, hamstring tightness, balance, spinal mobility and kinesiophobia, measured at baseline and after 6 weeks. RESULTS: The result suggested a significant improvement in pain, disability, hamstring tightness, kinesiophobia and balance. However, no significant improvement in spinal mobility (flexion and extension ROM) was observed during the sixth week between-group comparison. The maximum improvement was seen in group D followed by group C and group B in comparison to group A. CONCLUSION: It can be concluded that PEMF and retrowalking when given in combination significantly decrease pain, disability, hamstring tightness, kinesiophobia and improve balance patients with chronic non-specific low back pain.

INTRODUÇÃO: A dor lombar crônica inespecífica (DLCI) é uma condição importante em todo o mundo que tem graves consequências emocionais, sociais e econômicas. O gerenciamento é difícil, exigindo o desenvolvimento de abordagens novas, eficazes e seguras. OBJETIVOS: Este estudo foi realizado para examinar os efeitos dos Campos Eletromagnéticos Pulsados (CEMP) e do retrowalking sobre a dor, a incapacidade, a mobilidade da coluna vertebral, a rigidez dos isquiotibiais, o equilíbrio e a cinesiofobia em pacientes com dor lombar crônica não específica. MATERIAIS E MÉTODOS: Os participantes (n = 48) com DLCI crônica foram divididos aleatoriamente em quatro grupos: Grupo A: Grupo convencional, Grupo B: Grupo CEMP, Grupo C: Grupo retrowalking e Grupo D: Grupo CEMP e retrowalking. As intervenções foram realizadas três vezes por semana durante seis semanas. Os resultados foram dor, incapacidade, tensão nos isquiotibiais, equilíbrio, mobilidade da coluna vertebral e cinesiofobia, medidos na linha de base e após seis semanas. RESULTADOS: O resultado sugeriu uma melhora significativa na dor, na incapacidade, na tensão dos isquiotibiais, na cinesiofobia e no equilíbrio. Entretanto, não foi observada melhora significativa na mobilidade da coluna vertebral (flexão e extensão da ADM) quando a comparação entre os grupos foi feita na sexta semana. A melhora máxima foi observada no grupo D, seguida pelo grupo C e pelo grupo B, em comparação com o grupo A. CONCLUSÃO: Pode-se concluir que a CEMP e o retrowalking, quando administrados em combinação, diminuem significativamente a dor, a incapacidade, a rigidez dos isquiotibiais, a cinesiofobia e melhoram o equilíbrio dos pacientes com dor crônica não espinhal.

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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.

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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.

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The COVID-19 pandemic has driven the search for alternative therapies, including convalescent plasma, historically used in infectious diseases. Despite results in other diseases, its effectiveness against COVID-19 remains uncertain with conflicting results in clinical trials. A pragmatic, single-center, prospective, and open randomized controlled trial was carried out in a hospital in Brazil, with the aim of evaluating the impact of convalescent plasma on the clinical improvement of patients hospitalized with COVID-19. The World Health Organization (WHO) ordinal scale was used to measure clinical improvement, focusing on the reduction in disease severity by up to 2 points, while antibody and C-reactive protein levels were monitored over time. After hospital admission, participants were randomized 1:1 to receive convalescent plasma and standard treatment or to be part of the control group with standard treatment. Follow-up was carried out on days 1, 3, 7, 14 and/or at discharge. From January 14 to April 4, 2022, 38 patients were included, but 3 were excluded due to protocol deviations, resulting in a total of 35 patients: 19 in the control group and 16 in the plasma group. There was no significant difference in clinical improvement between the convalescent plasma group and the control group, nor in secondary outcomes. The study had limitations due to the small number of patients and limited representation of COVID-19 cases. Broader investigations are needed to integrate therapies into medical protocols, both for COVID-19 and other diseases. Conducting randomized studies is challenging due to the complexity of medical conditions and the variety of treatments available.

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Objective To present a named entity recognition method referred to as BioBERT-Att-BiLSTM-CRF for eligibility criteria based on the BioBERT pretrained model.The method can automatically extract relevant information from clinical trials and provide assistance in efficiently formulating eligibility criteria.Methods Based on the UMLS medical semantic network and expert-defined rules,the study established medical entity annotation rules and constructed a named entity recognition corpus to clarify the entity recognition task.BioBERT-Att-BiLSTM-CRF converted the text into BioBERT vectors and inputted them into a bidirectional long short-term memory network to capture contextual semantic features.Meanwhile,attention mechanisms were applied to extract key features,and a conditional random field was used for decoding and outputting the optimal label sequence.Results BioBERT-Att-BiLSTM-CRF outperformed other baseline models on the eligibility criteria named entity recognition dataset.Conclusion BioBERT-Att-BiLSTM-CRF can efficiently extract eligibility criteria-related information from clinical trials,thereby enhancing the scientific validity of clinical trial registration data and providing assistance in the formulation of eligibility criteria for clinical trials.

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With the prolongation of peritoneal dialysis time, the peritoneum probably confronts structural and functional deterioration due to multiple factors, which will affect the efficiency of peritoneal dialysis. Clinically effective measures to protect peritoneal function are still lacking. This article reviewed studies in the last decade on protection of peritoneal function, which included strategies on dialysis prescription, medicine treatments for protection of peritoneal function, and non-medicine treatments such as far-infrared therapy and stem cell transplantation, to provide guidances for subsequent researches.