Resultados de investigación

Trial identifier: NCT04357808, Background: The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and predictors of response. To date, data on the use of subcutaneous sarilumab is limited and no randomized trial results are available. Methods: Open label randomized controlled trial at a single center in Spain. We included adult patients admitted with microbiology documented COVID-19 infection, imaging confirmed pneumonia, fever and/or laboratory evidence of inflammatory phenotype, and no need for invasive ventilation. Participants were randomly assigned to receive sarilumab, a single 400 mg dose in two 200 mg subcutaneous injections, added to standard care or standard care, in a 2:1 proportion. Primary endpoints included 30-day mortality, mean change in clinical status at day 7 scored in a 7-category ordinal scale ranging from death (category 1) to discharge (category 7), and duration of hospitalization. The primary efficacy analysis was conducted on the intention-to-treat population. Results: A total of 30 patients underwent randomization: 20 to sarilumab and 10 to standard care. Most patients were male (20/30, 67%) with a median (interquartile range) age of 61.5 years (56-72). At day 30, 2/20 (10%) patients died in the sarilumab arm vs. none (0/10) in standard care (Log HR 15.11, SE 22.64; p = 0.54). At day 7, no significant differences were observed in the median change in clinical status (2 [0-3]) vs. 3 [0-3], p = 0.32). Median time to discharge (days) was similar (7 [6-11] vs. 6 [4-12]; HR 0.65, SE 0.26; p = 0.27). No significant differences were detected in the rate of progression to invasive and noninvasive mechanical ventilation. Conclusions and relevance: Our pragmatic pilot study has failed to demonstrate the benefit of adding subcutaneous sarilumab to standard care for mortality by 30 days, functional status at day 7, or hospital stay. Findings herein do not exclude a potential effect of sarilumab in severe COVID-19 but adequately powered blinded randomized phase III trials are warranted to assess the impact of the subcutaneous route and a more selected target population

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations, Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/design The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020, This research is funded by the Government of Spain, Ministry of Science and Innovation, Instituto de Salud Carlos III, grant n° COV20/00072 (Royal Decree-Law 8/2020, of 17 March, on urgent extraordinary measures to deal with the economic and social impact of COVID-19), co-financed by the European Regional Development Fund (FEDER) “A way to make Europe,” and supported by SCReN (Spanish Clinical Research Network), ISCIII, project PT17/0017/0009. The funding institutions do not have any role in the design of the study, data collection, analysis, or interpretation of data, nor in writing the manuscript

ClinicalTrials.gov Identifier: NCT03048825, Background Patients experiencing myocardial infarction (MI) remain at high risk of future major adverse cardiovascular events (MACE). While low-dose colchicine and spironolactone have been shown to decrease post-MI MACE, more data are required to confirm their safety and efficacy in an unselected post-MI population. Therefore, we initiated the CLEAR SYNERGY (OASIS 9) trial to address these uncertainties. Methods The CLEAR SYNERGY trial is a 2 × 2 factorial randomized controlled trial of low-dose colchicine 0.5 mg daily versus placebo and spironolactone 25 mg daily versus placebo in 7,062 post-MI participants who were within 72 hours of the index percutaneous coronary intervention (PCI). We blinded participants, healthcare providers, research personnel, and outcome adjudicators to treatment allocation. The primary outcome for colchicine is the first occurrence of the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia-driven revascularization. The coprimary outcomes for spironolactone are (1) the composite of the total numbers of cardiovascular death or new or worsening heart failure and (2) the first occurrence of the composite of cardiovascular death, new or worsening heart failure, recurrent MI or stroke. We finished recruitment with 7,062 participants from 104 centers in 14 countries on November 8, 2022, and plan to present the results in the fall of 2024. Conclusions CLEAR SYNERGY is a large international randomized controlled trial that will inform the effects of low-dose colchicine and spironolactone in largely unselected post-MI patients who undergo PCI. (ClinicalTrials.gov Identifier: NCT03048825)

Recent years have seen great advances in the use of clinical ultrasound imaging in both hospital emergency departments and out-of-hospital settings. However, all new techniques require up-to-date definitions of competencies relevant to the clinical realities of different specialties and the geographic settings in which specialists work. To that end, a group of experts in clinical ultrasound reviewed the evidence available in the literature and strictly applied the Delphi method to define the competencies relevant to emergency physicians. The group worked with the starting premise that clinical ultrasound imaging should be a common competency across the specialty., En los últimos años se han producido grandes avances en el uso de la ecografía clínica tanto en los servicios de urgencias hospitalarios como en el ámbito extrahospitalario. Sin embargo, toda nueva técnica requiere de definiciones actualizadas de competencias relevantes para las realidades clínicas de las diferentes especialidades y los entornos geográficos en los que trabajan los especialistas. Para ello, un grupo de expertos en ecografía clínica revisó la evidencia disponible en la literatura y aplicó estrictamente el método Delphi para definir las competencias relevantes para los médicos de urgencias. El grupo trabajó con la premisa de partida de que la ecografía clínica debería ser una competencia común para toda la especialidad., Yes

Hepatitis B virus (HBV) infection remains a global public health problem. HBV vaccination is the most effective tool to reduce the incidence of HBV disease. Despite there has not been new clinical developments for the treatment of chronic hepatitis B in the last few years, changing epidemiology and current insights on natural history, diagnostic tools and therapy indications make necessary an update of the former version of the consensus document of the Spanish Association for Study of the Liver on the treatment of hepatitis B infection published in 2012. The current document updates the management of chronic hepatitis B. The treatment of choice is the long-term administration of a nucleos(t)ide analogue with high barrier to resistance (entecavir, tenofovir or tenofovir alafenamide). Pegylated interferon may be an option in patients with non-advanced liver disease, but its applicability is limited due to the low efficacy and poor tolerability. All patients must be monitored for the risk of progression to advanced liver disease and development of hepatocellular carcinoma., La infección por el virus de la hepatitis B (VHB) continúa siendo un problema global de salud pública. La vacunación frente al VHB, introducida en España en la década de 1990, constituye el método más eficaz para reducir la incidencia de la enfermedad. No obstante, la migración procedente de países donde la prevalencia de la infección es alta contribuye a que en nuestro país la tasa esté aún entre el 0,5 y el 1%. El espectro de la enfermedad crónica ocasionada por el VHB es muy variable y abarca desde el portador inactivo a pacientes con hepatitis crónica, cirrosis y carcinoma hepatocelular. A pesar de que en los últimos años no se han producido grandes avances en el desarrollo clínico de nuevos fármacos para el tratamiento de la hepatitis B crónica, los cambios en la epidemiología, en el conocimiento de la historia natural, métodos diagnósticos e indicaciones de tratamiento aconsejan la actualización del documento de consenso de la Asociación Española para el Estudio del Hígado (AEEH) sobre el tratamiento de la infección por el VHB publicado en el año 2012. El documento de la AEEH revisa el tratamiento de la hepatitis B crónica y establece como mejor pauta la administración prolongada de un análogo de nucleós(t)ido con alta barrera genética a la resistencia (entecavir, tenofovir o tenofovir alafenamida). El interferón-pegilado constituye una alternativa en pacientes con enfermedad hepática poco avanzada, pero su aplicabilidad es limitada por su baja eficacia y efectos adversos frecuentes. En todos los pacientes se debe evaluar el riesgo de progresión a enfermedad hepática avanzada y de desarrollo de carcinoma hepatocelular. Determinados subgrupos de pacientes con infección crónica por VHB deben ser incluidos en programas de vigilancia para el diagnóstico precoz de carcinoma hepatocelular, que constituye en el momento actual la principal complicación de la enfermedad., Sí

Este podcast traza la genealogía de la Responsabilidad Social Corporativa (RSC) desde sus antecedentes en la década de 1930 hasta las actuales corrientes del siglo XXI. En los años treinta y cuarenta del siglo XX, podemos identificar iniciativas voluntarias impulsadas por empresarios que pretenden mitigar las consecuencias negativas asociadas a la crisis económica de 1929. Sin embargo, estas iniciativas, que si pueden ser consideradas medidas de Responsabilidad Social (RS), no constituyen una estrategia corporativa en sentido estricto (no son RSC). La RSC nace en los años cincuenta del siglo XX en los Estados Unidos con figuras pioneras como Howard R. Bowen. Las décadas de 1960 y 1970 constituyen una etapa de esplendor y debate marcada por las críticas que a este concepto desarrolla Milton Friedman y por el desarrollo de modelos teóricos tan influyentes como el de Archie B. Carroll. En los años ochenta cobran relevancia nociones como "ética empresarial" y "stakeholders", mientras que en los noventa la RSC es comprendida como un factor de competitividad de la empresa. Finalmente, en el siglo XXI este concepto evoluciona hacia un enfoque estratégico, en el que emergen nociones clave como “valor compartido” o “Agenda 2030”

Este podcast presenta resultados de investigación del proyecto China Horizons project sobre la traducción en el mundo chino, más concretamente sobre la traducción en la política china. Mario Santander (UAM) examina el informe de Xi Jinping en chino de fecha 16 de octubre de 2022 ante el XX Congreso del Partido Comunista Chino (PCCh) en sus traducciones oficiales al inglés, francés y español. Mediante un enfoque comparativo y un análisis contrastivo, se analiza la forma de llevar a cabo las traducciones según el país receptor y el mensaje que el PCCh quiere presentar ante países de diferente cultura lingüística, que resulta en diferencias en el uso de términos políticos, económicos y sociales, This podcast presents research findings of the China Horizons’ project on translation in the Chinese world, more specifically on translation in Chinese politics. Mario Santander (UAM) examines Xi Jinping’s report in Chinese dated October 16, 2022 to the 20th Congress of the Chinese Communist Party (CCP) in its official translations into English, French and Spanish. Through a comparative approach and contrastive analysis, it analyzes the way translations are carried out according to the recipient country and the message that the CCP wants to present to countries with different linguistic cultures, resulting in differences in the use of political, economic and social terms, This research is a result of the project “China Horizons: Dealing with a Resurgent China” (DWARC) (grant no. 101061700) funded under the European Union’s Horizon Europe research and innovation programme

En este episodio nos adentramos en el fascinante mundo de la influencia cultural y el soft power. ¿Cómo moldean las exportaciones culturales de Corea del Sur —como el K-pop, los K-dramas y los esports— las dinámicas regionales? ¿Y cómo está China aprovechando sus propias industrias culturales, desde el cine hasta los videojuegos, para proyectar influencia dentro y fuera de sus fronteras? Acompáñanos mientras exploramos: El auge de la cultura pop surcoreana como fenómeno global. Las estrategias en evolución de China en industrias culturales y soft power. Tensiones, colaboraciones y competencia entre ambos países. Lo que este juego de influencias revela sobre política, identidad y poder en Asia Oriental, In this episode, we dive into the fascinating world of cultural influence and soft power. How do South Korea’s global cultural exports—like K-pop, K-dramas, and esports—shape regional dynamics? And how is China leveraging its own cultural industries, from cinema to video games, to project influence at home and abroad? Join us as we explore: The rise of South Korea’s pop culture as a global phenomenon. China’s evolving strategies in cultural industries and soft power. Tensions, collaborations, and competition between the two countries. What this interplay reveals about politics, identity, and influence in East Asia, This research is a result of the project “China Horizons: Dealing with a Resurgent China” (DWARC) (grant no. 101061700) funded under the European Union’s Horizon Europe research and innovation programme

New French extreme cinema combines existentialism with shock, hyper violence, and transgressions of women’s bodies. I contend such imagery is best understood as a representation of violence that enables enlightenment in and through the representation of women’s monstrosity and abjection. I examine this phenomenon through four films from New French Extremism’s inaugural cycle. El Nuevo Extremismo Francés combina el existencialismo con el shock, la hiperviolencia y las transgresiones de los cuerpos de las mujeres. En este artículo argumento que dicho imaginario se entiende mejor como una representación de la violencia que permite acceder al conocimiento mediante la representación de la monstruosidad y el abyecto de la mujer. Examino este fenómeno a través de cuatro películas de la primera ola de dicho movimiento., New French extreme cinema combines existentialism with shock, hyper violence, and transgressions of women’s bodies. I contend such imagery is best understood as a representation of violence that enables enlightenment in and through the representation of women’s monstrosity and abjection. I examine this phenomenon through four films from New French Extremism’s inaugural cycle. El Nuevo Extremismo Francés combina el existencialismo con el shock, la hiperviolencia y las transgresiones de los cuerpos de las mujeres. En este artículo argumento que dicho imaginario se entiende mejor como una representación de la violencia que permite acceder al conocimiento mediante la representación de la monstruosidad y el abyecto de la mujer. Examino este fenómeno a través de cuatro películas de la primera ola de dicho movimiento.