Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial.

INTRODUCTION: SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms. METHODS AND ANALYSIS: This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms' questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4. ETHICS AND DISSEMINATION: This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals. TRIAL REGISTRATION NUMBER: NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

Consumption of ultra-processed foods and mental health of pregnant women from the South of Brazil.

The objective of this study is to evaluate the association between the consumption of ultra-processed foods (UPF) and the mental health of pregnant women from the South of Brazil. This is a cross-sectional study carried out in Criciúma, Brazil, through face-to-face interviews, from April to December 2022. Pregnant women aged 18 or older who underwent prenatal care in the forty-eight basic health care units of the municipality and who were in their third trimester of pregnancy were included. High consumption of UPF was considered as six or more items or subgroups of UPF consumed on the day before the interview, using the Nova-UPF screener. The mental health variables were depressive symptoms, stress, sadness and anxiety. Crude and adjusted analyses were conducted using the Fisher's exact test and the Poisson regression with robust variance. In total, 428 pregnant women were studied; most of them were aged between 20 and 25 years and were white. Pregnant women who presented high consumption of UPF were 1·42-fold (95 % CI 1·06, 1·92) more likely to experience anxiety and presented a prevalence 56 % (95 % CI 1·18, 2·07) higher of stress when compared with those who did not present high consumption of UPF. The prevalence of depressive symptoms and feelings of sadness was 1·31-fold (95 % CI 1·08, 1·60) and 3·41-fold (95 % CI 1·77, 6·58) higher among those with high consumption of UPF, respectively. The results suggest that diet quality is associated with the mental health of pregnant women. Promoting joint actions focused on food and nutritional education, and mental health, for pregnant women, is necessary.

Use of a menthol popsicle in managing postoperative thirst in patients undergoing radical prostatectomy: A randomized clinical trial.

Background and aim: Thirst is a real bother that most patients feel in the immediate postoperative period when they still need to fast. Many approaches regarding symptomatic relief strategies have been described in the literature, but strategies with cold water and/or menthol are effective in quenching thirst, as they act on pre-absorptive mechanisms. This study aims to evaluate the effectiveness of using menthol popsicles in relieving postoperative thirst in patients undergoing radical prostatectomy. Material and methods: This is a randomized controlled clinical trial with a quantitative approach. In all, 44 patients were evaluated in the immediate postoperative period of radical prostatectomy, with the intensity and discomfort of thirst being evaluated initially and subsequently. The study consisted of two groups: (1) the placebo group, popsicles without the addition of menthol substrates and (2) the experimental group, popsicles with the addition of 0.05% minty substrates. Results: The results demonstrate that the sociodemographic and clinical characteristics were homogeneous at the α = 5% significance level, except the occupation variable. The test detected changes in the intensity and discomfort of thirst in relation to the pre- and post-intervention times for the primary outcome when the groups were analyzed separately and for the interaction of the group versus time, there was no statistical difference between the groups. Conclusion: It was possible to prove that both the menthol popsicle and the popsicle without the addition of menthol were effective in relieving postoperative thirst in patients undergoing radical prostatectomy, but there was no statistically significant difference when comparing the two groups. Trial registration: The Brazilian Registry of Clinical Trials (RBR-8c3chr7).

Use of ginger to control nausea and vomiting caused by chemotherapy in patients with cervical cancer undergoing treatment: An experiment.

INTRODUCTION: Uterine cervix tumors have an invasive nature, with the capacity to proliferate to surrounding organs such as the vagina, bladder, and rectum, as well as the capacity for dissemination and involvement of structures distant from its place of origin. According to the International Federation of Gynecology and Obstetrics, patients with stages IB I, IB I microscopic (small dimension <4 cm) are indicated for radiotherapy or adjuvant chemoradiotherapy with cisplatin (40 mg/m2). However, cisplatin has side effects such as hematological implications (anemia, neutropenia, and thrombocytopenia), gastrointestinal disorders (nausea, vomiting, diarrhea, constipation), and fatigue. Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia. This study aimed to evaluate the effects of ginger on chemotherapy-induced nausea and vomiting in patients with cervical cancer undergoing treatment with cisplatin and radiotherapy. METHODS AND ANALYSES: A randomized intervention clinical and controlled trial with a triple-blind design is described, comparing the effects of institutional antiemetic therapy alone, as well as in combination with 2 different ginger concentrations. ETHICS AND DISSEMINATION: Due to the nature of the study, we obtained approval from the Division Ethics Committee of Liga Contra o Câncer. All participants signed an informed consent form prior to randomization. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data. TRIAL REGISTRATION NUMBER: This study is registered in the Brazilian Registry of Clinical Trials under number RBR-47yx6p9. This study was approved by the Division Ethics Committee of Liga Contra o Câncer under CAAE 40602320.0.0000.5293.

Implementação de ciclo de melhoria nos registros em prontuários hospitalares: um estudo quase experimental

RESUMO Objetivo: Implantar e avaliar um programa de melhoria dos registros em prontuários do um hospital do município de Farias Brito, estado do Ceará, Brasil. Material e Método: Trata-se de um estudo com abordagem quantitativa, quase experimental do tipo antes e depois de avaliação de critérios de qualidade. A pesquisa foi realizada entre janeiro de 2017 e julho de 2018. Foram avaliados 87 registros em prontuários selecionados de forma aleatória, realizados pela equipe multiprofissional totalizando 35 profissionais. Foi realizado em seis etapas: 1) Identificação e priorização de um problema de qualidade, 2) Análise das causas do problema, 3) Desenvolvimento de critérios para avaliar o nível de qualidade, 4) Avaliação do nível de qualidade, 5) Intervenção de melhoria dirigida aos critérios mais problemáticos e 6) Reavaliação do nível de qualidade. Para avaliar a qualidade, antes e depois da intervenção, foi realizado cálculo da estimativa pontual e do intervalo de confiança (IC= 95%) do nível de cumprimento de oito critérios. Para avaliar o efeito da intervenção, foi estimada melhoria absoluta e relativa de cada teste de hipótese unilateral por meio do cálculo do valor de Z. No ciclo de melhoria, os dados foram analisados pelo Gráfico de Pareto. Resultados: Na medição inicial, foram obtidos índices de cumprimento de 36,30% em média, enquanto na segunda medição, notou-se um aumento na média de cumprimentos de todos os critérios em 19,45%. Conclusão: Percebe-se que o ciclo de melhoria é uma ferramenta efetiva para fortalecer a qualidade dos serviços desenvolvidos especialmente a qualidade dos registros em prontuários do hospital.

ABSTRACT Objective: To implement and evaluate a program to improve medical records in a hospital located in the municipality of Farias Brito, Ceará State, Brazil. Material and Method: Quasi-experimental study of the type before and after the evaluation of quality criteria, with a quantitative approach. The survey was conducted between January 2017 and July 2018. 87 records were evaluated in randomly selected medical records that had been performed by the multi-professional team consisting of 35 professionals. The research was carried out in six steps: 1) Identification and prioritization of a quality problem, 2) Analysis of the causes of the problem, 3) Development of criteria to evaluate the quality level, 4) Evaluation of the quality level, 5) Improvement intervention aimed at the most problematic criteria, and 6) Re-evaluation of the quality level. To assess quality before and after the intervention, point estimation and confidence interval (CI= 95%) of the level of compliance to eight criteria was calculated. To evaluate the effect of the intervention, absolute and relative improvement of each one-sided hypothesis test was estimated by calculating the Z-score. In the improvement cycle, data were analyzed using Pareto chart. Results: In the first measurement, compliance rates of 36.30% on average were obtained, while in the second measurement there was an increase in the average level of compliance of all criteria by 19.45%. Conclusion: It is clear that the improvement cycle is an effective tool to strengthen the quality of the hospital services, especially when related to quality of patient's medical records.

RESUMEN Objetivo: Implementar y evaluar un programa para mejorar los registros en la historia clínica de un hospital del município de Farias Brito, estado de Ceará, Brasil. Material y Método: Estudio con enfoque cuantitativo, cuasi-experimental del tipo antes y después de la evaluación de criterios de calidad. La encuesta se realizó entre enero de 2017 y julio de 2018. Se evaluaron 87 registros de historias clínicas, seleccionados al azar, realizados por el equipo multiprofesional, totalizando 35 profesionales. Se llevó a cabo en seis pasos: 1) Identificación y priorización de un problema de calidad, 2) Análisis de las causas del problema, 3) Desarrollo de criterios para evaluar el nivel de calidad, 4) Evaluación del nivel de calidad, 5 ) Intervención de mejora dirigida a los criterios más problemáticos y 6) Reevaluación del nivel de calidad. Para evaluar la calidad, antes y después de la intervención, se calculó la estimación puntual y el intervalo de confianza (IC = 95%) del nivel de cumplimiento de ocho criterios. Para evaluar el efecto de la intervención, se estimó la mejora absoluta y relativa de cada prueba de hipótesis unilateral mediante el cálculo del valor Z. En el ciclo de mejora, los datos se analizaron mediante el diagrama de Pareto. Resultados: En la medición inicial se obtuvieron tasas de cumplimiento de 36,30% en promedio, mientras que en la segunda medición hubo un aumento en el promedio de cumplimiento de todos los criterios en 19,45%. Conclusión: Se observa que el ciclo de mejora es una herramienta eficaz para fortalecer la calidad de los servicios desarrollados, especialmente la calidad de los registros en la Historia clínica de los pacientes.

Late Cognitive Consequences of Gestational Diabetes to the Offspring, in a New Mouse Model.

Gestational diabetes mellitus (GD) is a form of insulin resistance triggered during gestation, which affects approximately 10% of pregnant women. Although previously considered a transient condition with few long-term consequences, growing evidence suggest that GD may be linked to permanent metabolic and neurologic changes in the offspring. Currently available GD models fail to recapitulate the full spectrum of this disease, thus providing limited information about the true burden of this condition. Here, we describe a new mouse model of GD, based on the administration of an insulin receptor antagonist (S961, 30 nmol/kg s.c. daily) during pregnancy. Pregnant mice developed increased fasting glycemia and glucose intolerance in the absence of maternal obesity, with a return to normoglycemia shortly after parturition. Moreover, we showed that the adult offspring of GD dams presented pronounced metabolic and cognitive dysfunction when exposed to short-term high-fat diet (HFD). Our data demonstrate that S961 administration to pregnant mice comprises a valuable approach to study the complex pathophysiology of GD, as well as strategies focused on prevention and treatment of both the mother and the offspring. Our findings suggest that the offspring of GD mothers are more susceptible to metabolic and cognitive impairments when exposed to high-fat diet later in life, thus indicating that approaches to prevent and treat these late effects should be pursued.

Noninvasive measurements of hemodynamic, autonomic and endothelial function as predictors of mortality in sepsis: A prospective cohort study.

BACKGROUND AND AIM: Sepsis is associated with marked alterations in hemodynamic responses, autonomic dysfunction and impaired vascular function. However, to our knowledge, analysis of noninvasive markers to identify greater risk of death has not yet been investigated. Thus, our aim was to explore the prognostic utility of cardiac output (CO), stroke volume (SV), indices of vagal modulation (RMSSD and SD1), total heart rate variability (HRV) indices and FMD of brachial artery (%FMD), all measured noninvasively, in the first 24 hours of the diagnosis of sepsis. METHODS: 60 patients were recruited at ICU between 2015 and 2017 and followed by 28 days. CO, SV, RR intervals were measurement. Doppler ultrasound was used to assess brachial artery FMD and the hyperemic response were obtained (%FMD). Patients were divided by survivors (SG) and nonsurvivors groups (NSG). RESULTS: A total of 60 patients were analysed (SG = 21 and NSG = 39). Survivors were younger (41±15 years vs. 55±11 years) and used less vasoactive drugs. As expected, APACHE and SOFA scores were lower in NSG compared to SG. In addition, higher SD1, triangular index, % FMD, velocity baseline and hyperemia flow velocity as well as lower HR values were observed in the SG, compared to NSG (P<0.05). Interestingly, RMSSD and SD1 indices were independent predictors of %FMD, ΔFMD and FMDpeak. RMSSD threshold of 10.8ms and %FMD threshold of -1 were optimal at discriminatomg survivors and nonsurvivors. CONCLUSION: Noninvasive measurements of autonomic and endotelial function may be important markers of sepsis mortality, which can be easily obtained in the early stages of sepsis at the bedside.

Use of herbal medicines by elderly patients: A systematic review.

OBJECTIVES: We aimed to survey the published literature for articles that describe the use of herbal supplements by elderly patients and to summarize important aspects of selected studies, including most commonly used supplements, study type, study location, and potential hazards of herbal supplement use. METHODS: Literature searches were conducted on three scientific/medical databases: Medline, Web of Science, and Scopus. Search results were examined for articles involving the use of herbal products in the elderly population that met selection criteria. RESULTS: Initial searches yielded 1297 articles. Of these original results, only 16 met specific selection criteria. Twelve (75%) of studies identified were performed in North America. Nine studies (56.25%) were conducted in the United States. Seven of the studies were cross-sectional (43.8%). The most commonly reported were gingko biloba, garlic, ginseng, aloe vera, chamomile, spearmint, and ginger. Of these, gingko and garlic are the most commonly used among community-dwelling elderly. Both of these supplements have the potential to interact with anticoagulants and produce bruising or bleeding problems. CONCLUSIONS: The use of herbal supplements is common among the elderly, a population that takes a disproportionate share of prescription medications compared to that taken by younger populations. Among the problems uncovered by these studies was a lack of dialog between medical professionals and patients about the use of herbal supplements. Prescribers need to consider the use of herbal supplements and discuss the matter with their elderly patients when making decisions about pharmacological treatments.