1,721,181 research outputs found

    Participation of women in clinical trials: not yet time to rest on our laurels

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    From the stories of workplace impropriety and sexual misconduct allegations, a movement emerged as a supportive platform for women to share their experiences in solidarity. This movement’s call for action has challenged all fields to examine institutionalized power dynamics and gender biases through a feminist lens. Advancing sex and gender considerations in the health care field can add to this growing movement. In the 1990s, the U.S. Food and Drug Agency’s (FDA’s) Office of Women’s Health established a specific program dedicated to support FDA research and development activities related to improving women’s health (1). Their mandate is to improve clinical study designs and procedures to better identify and evaluate possible sex differences in FDA-regulated products. As a response to various interest groups advocating for adequate representation of women in cardiovascular clinical trials, the FDA, as well as other agencies (i.e., National Institutes of Health [2], Canadian Institute of Health Research) established policies focused on greater participation of women in clinical trials to strengthen science and guarantee quality and generalizability of biomedical research, breaking the ceiling of health inequity. Reports of FDA drug approvals showed that women’s participation in clinical trials has progressively increased compared with reports from the 1990s that demonstrated a consistent underrepresentation of women (<20%) (3–5). Although women’s participation increased to 45% for new drugs approved between 2010 and 2012 (5), inclusion varies widely by indication and has been the lowest in cardiovascular trials (3–5)

    Impact of biological sex and genderrelated factors on public engagement in protective health behaviours during the COVID-19 pandemic : cross-sectional analyses from a global survey

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    Given the main objective of this study was to examine whether sex and gender-related factors were associated with the public’s adherence to COVID-19-recommended protective health behaviours. Design This was a retrospective analysis of the survey that captured data on people’s awareness, attitudes and behaviours as they relate to the COVID-19 policies. Setting Data from the International COVID-19 Awareness and Responses Evaluation survey collected between March 2020 and February 2021 from 175 countries. Participants Convenience sample around the world.Fil: Dev, Rubee. University of Alberta; Canada.Fil: Raparelli, Valeria. University of Alberta; Canada.Fil: Raparelli, Valeria. University of Ferrara; Italy.Fil: Bacon, Simon L. Montreal Behavioural Medicine Centre; Canada.Fil: Bacon, Simon L. Concordia University; Canada.Fil: Lavoie, Kim L. Montreal Behavioural Medicine Centre; Canada.Fil: Lavoie, Kim L. Université du Québec à Montréal; Canada.Fil: Pilote, Louise. McGill University; Canada.Fil: Norris, Colleen M. University of Alberta; Canada.Fil: Losada, Analía Verónica. Universidad de Flores; Argentina

    Demystifying How to Incorporate Sex and Gender Into Cardiovascular Research: A Practical Guide

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    Understanding the role of biological sex and sociocultural gender in cardiovascular medicine is one of the first steps toward personalized medicine. Sex- and gender-based analysis (SGBA) seeks to systematically incorporate sex and gender-related variables as well as the intersectionality with other factors in medical research, with the goal of providing evidence for equitable cardiovascular clinical practice. This article outlines simple steps that summarize an approach to SGBA that may ultimately be a game changer in cardiovascular research and practic

    Correction to: Sex and Gender Differences in Ischemic Heart Disease: Endocrine Vascular Disease Approach (EVA) Study Design

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    : The authors of this study protocol would like to amend it and clarify that medication adherence was assessed using the 4-item validated Morisky, Green, Levine scale [Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74] rather than the 4-item Morisky Medication Adherence Scale

    Hypoalbuminemia and Risk of Portal Vein Thrombosis in Cirrhosis

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    Background and aims: Hypoalbuminemia, as defined by serum albumin (SA) levels ≤35 g/L, is associated to venous and arterial thrombosis in general population and in patients at risk of cardiovascular disease. It is unknown if SA ≤35 g/L is also associated to portal vein thrombosis (PVT) in cirrhosis. Methods: Cirrhotic patients enrolled in the Portal vein thrombosis Relevance On Liver cirrhosis: Italian Venous thrombotic Events Registry (PRO-LIVER) study (n = 753), were followed-up for 2 years to assess the risk of PVT, that was diagnosed by Doppler ultrasonography. Child-Pugh classes, Model for End-Stage Liver Disease score, presence of hepatocellular carcinoma and laboratory variables including SA, D-dimer, and high-sensitivity C-reactive protein (hs-CRP) were measured at baseline. Results: SA ≤35 g/L was detected in 52% of patients. A logistic multivariate regression analysis showed that higher Child-Pugh class, hepatocellular carcinoma and thrombocytopenia were significantly associated to SA ≤35 g/L. In a subgroup of patients where data regarding hs-CRP and D-dimer were available, SA ≤35 g/L was inversely associated with hs-CRP and D-dimer. During the follow-up, a total of 61 patients experienced PVT. A Kaplan Meier survival analysis showed SA ≤35 g/L was associated to increased risk of PVT compared to SA >35 g/L (P = .005). A multivariate Cox proportional hazards regression analysis showed that male sex, lower platelet count, and SA ≤35 g/L remained associated to PVT after adjusting for confounding factors. Conclusion: Cirrhotic patients with SA ≤35 g/L are at higher risk of experiencing PVT compared to those with SA >35 g/L and could be considered as potential candidates to anticoagulant prophylaxis for PVT prevention

    Blood pressure variability in normotensive perimenopausal women: non-dipping status, maximum blood pressure and arterial stiffness

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    Background: Postmenopausal women are more likely to have uncontrolled hypertension and are at higher risk of cardiovascular disease compared with age-matched men. Blood pressure variability is emerging as a predictor of adverse cardiovascular outcomes and may be implicated in the relationship between menopause and worsened vascular health in women. We conducted an observational study, BRAVE (Blood pRessure And Vascular hEalth around menopause) to study this relationship. Method: Normotensive perimenopausal women were recruited. Blood pressure variability was measured through 24-h blood pressure monitoring. Vascular health was assessed through arterial stiffness (carotid-femoral pulse wave velocity), carotid intima-media thickness and endothelial function (reactive hyperemic index). Multivariate models were performed to identify factors associated with blood pressure variability and arterial stiffness in perimenopausal women. Results: Forty-nine healthy women (mean age 52.9 ± 4.0, 63% postmenopausal) were recruited. There was a high prevalence (40%) of night non-dipping, a measure of an abnormal pattern of blood pressure variability. Aside from night dipping, other measures of blood pressure variability were similar between premenopausal and postmenopausal women. In the multivariate analysis, body mass index was the only factor associated independently with different measures of blood pressure variability, including the maximum overnight blood pressure (ß = 1.95, p < 0.01). The latter was also significantly associated with arterial stiffness (ß = 0.035, p = 0.048). Finally, poor sleep was independently associated with an increase in arterial stiffness. Conclusions: Abnormal blood pressure variability, particularly night non-dipping, is common in normotensive perimenopausal women. Maximum overnight blood pressure is independently associated with arterial stiffness and may identify women at higher cardiovascular risk

    Cardiovascular Pathophysiology, Epidemiology, and Treatment Considerations of Coronavirus Disease 2019 (COVID-19): A Review

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    The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rapidly evolving, with important cardiovascular considerations. The presence of underlying cardiovascular risk factors and established cardiovascular disease (CVD) may affect the severity and clinical management of patients with COVID-19. We conducted a review of the literature to summarize the cardiovascular pathophysiology, risk fac-tors, clinical presentations, and treatment considerations of COVID-19 patients with underlying CVD. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for the SARS-CoV-2 virus, and it is associated with the cardiovascular system. Hypertension, diabetes, and CVD are the most common comorbidities in COVID-19 patients, and these factors have been associated with the progres-sion and severity of COVID-19. However, elderly populations, who develop more-severe COVID-19 complications, are naturally exposed to these comorbidities, underscoring the possible confounding of age. Observational data support international cardiovascular societies' recommendations to not discontinue ACE inhibitor/angiotensin-receptor blocker therapy in patients with guideline indications for fear of the increased risk of SARS-CoV-2 infection, severe disease, or death. In addition to the cardiotoxicity of experimental antivirals and potential interactions of experimental therapies with cardiovascular drugs, several strategies for cardiovascular protection have been rec-ommended in COVID-19 patients with underlying CVD. Troponin elevation is associated with increased risk of in-hospital mortality and adverse outcomes in patients with COVID-19. Cardiovascular care teams should have a high index of suspicion for fulminant myocarditis-like presentations being SARS-CoV-2 positive, and remain vigilant for cardiovascular complications in COVID-19 patients

    The coagulopathy of chronic liver disease: Is there a causal relationship with bleeding? Yes

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    Variceal hemorrhage is a major cause of death in patients with cirrhosis Much still could be performed in clinical practice to reduce the risk for bleeding in cirrhotic patients and accurate predictive rules should be provided for early recognition of high-risk patients Liver cirrhosis patients present a complex hemostatic dysfunction with prolongation of bleeding time, chronic coagulation activation, and secondary hyperfibrinolysis Therefore. liver failure determines an acquired coagulopathy that has been considered to be one potential underlying mechanism of bleeding Endotoxemia may play a pivotal role in activating clotting system in portal and systemic circulation and it could represent a common mechanism accounting for portal vein thrombosis, systemic hyperfibrinolysis and eventually gastrointestinal bleeding Nevertheless, clinical trials should also be planned to investigate the causal relationship between acquired coagulopathy and bleeding in patients with chronic liver disease. (C) 2010 European Federation of Internal Medicine Published by Elsevier BV All rights reserve
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