2,782,189 research outputs found

    Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia : A Randomized, Phase III Clinical Trial (SARTRE Study)

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    Publisher Copyright: © 2021, The Author(s).Introduction: SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS). Methods: We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15. Results: A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48–2.20). No relevant safety issues were identified. Conclusions: In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15.Peer reviewe

    The role of imagination in Bergman, Klein and Sartre

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    This thesis was submitted for the degree of Doctor of Philosophy and was awarded by Brunel UniversityThis thesis provides an inter-disciplinary study of selected works by Ingmar Bergman. I explore how key concepts from Melanie Klein and Jean-Paul Sartre apply to the focus on characters in a state of heightened imagination; and the value placed on imagination in the construction of these films. This involves recognition of the way an active response from the viewer is encouraged. Klein, Sartre and Bergman also attend to contextual factors that challenge any notion of subjectivity as sovereign and the power of imagination is frequently placed in a social context. All three figures develop their ideas within specialised fields drawing on the influence of others. Chapter 2 shows how Klein’s ideas relate to the influence of Freud before exploring how her work can be applied to Bergman’s films through the example of Wild Strawberries. Chapter 3 concentrates on Sartre’s early work, The Imaginary and considers how this is significant in relation to some of Sartre’s better-known philosophical ideas developed during and after the Second World War. These ideas will lead to an exploration of The Seventh Seal. Chapters 4, 5, and 6 focus on three films from distinct parts of Bergman’s career: Summer with Monika, The Virgin Spring and Hour of the Wolf. In Chapter 4 this will be preceded by a brief over-view of three more films from the early part of Bergman’s career. These chapters explore how Kleinian and Sartrean ideas can be incorporated in close analysis, and alongside selected critical responses to the films. The analysis integrates key points from Klein and Sartre in a methodology specific to film studies. This will include analysis of cinematic elements such as camera work and lighting, and recognition of narrative structure and character developmen

    The UN-SUSTAINABLE Match in HCV Recipients. Evidences from the Italian D-MELD Study on Balancing Donor-Recipient Risk Factors

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    The UN-SUSTAINABLE Match in HCV Recipients. Evidences from the Italian D-MELD Study on Balancing Donor-Recipient Risk Factor

    Appendectomy during the COVID-19 pandemic in Italy: a multicenter ambispective cohort study by the Italian Society of Endoscopic Surgery and new technologies (the CRAC study)

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    Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. The hypothesis is that a signifcant reduction in the number of emergent appendectomies was observed during the pandemic, restricted to complex cases. The study aimed to analyse emergent surgical appendectomies during pandemic on a national basis and compare it to the same period of the previous year. This is a multicentre, retrospective, observational study investigating the outcomes of patients undergoing emergent appendectomy in March–April 2019 vs March–April 2020. The primary outcome was the number of appendectomies performed, classifed according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs open) and the complication rates. One thousand fve hundred forty one patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the inclusion criteria: 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.2%) in 2019. According to AAST, patients with complicated appendicitis operated in 2019 were 30.3% vs 39.9% in 2020 (p=0.001). We observed an increase in the number of post-operative complications in 2020 (15.9%) compared to 2019 (9.6%) (p<0.001). The following determinants increased the likelihood of complication occurrence: undergoing surgery during 2020 (+67%), the increase of a unit in the AAST score (+26%), surgery performed>24 h after admission (+58%), open surgery (+112%) and conversion to open surgery (+166%). In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. During the frst pandemic wave, patients undergoing surgery were more frequently afected by more severe appendicitis than the previous year’s timeframe and experienced a higher number of complications. Trial registration number and date: Research Registry ID 5789, May 7th, 202

    The role of the basic arrhythmia research. The continued need for experiments in the intact heart and organism. Study group on experimental research of the working group on arrhythmias of the european society of cardiology

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    This article is the results of a Task Force of the Working group on cardiac arrhythmias of the European society of cardiology (ESC). The consensus document focuses on the fondamentals of experimental models to study cardiac arrhythmogensis and suggest a scheme for a systematic approach allowing comparisosn of results between different labs

    Risk factors for atrophic chronic gastritis in a European population: results of the Eurohepygast study

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    Background and aims: The development of atrophic chronic gastritis (ACG) is multifactorial, involving environment as well as host responses to Helicobacter pylori infection. The aim of this study was to determine factors involved in ACG in a European dyspeptic population. Methods: Data concerning sociodemographics, social behaviour, biological aspects, diet, and virulence factors of H pylori strains were collected in a cross sectional study from 19 European centres in 14 countries. Dyspeptic H pylori positive patients with ACG or non-ACG (NACG) at histology were included. Anti-CagA antibodies were evaluated by two immunoblot tests and anti-VacA antibodies by one. Logistic regression models were constructed, and estimated odds ratios (ORs) and 95% confidence intervals (95% Cl) were calculated from the coefficients. Results: Of the 451 patients included in the study, 267 were analysed: 202 had NACG and 65 ACG. Mean age was 44.4 years and 63% were women. Risk factors for atrophy identified by multivariate analysis were: age over 60 years (OR 4.14, 95% Cl 1.79-9.58), coffee consumption (OR 2.35, 95% Cl 1.07-5.16), sedative consumption (OR 2.17, 95% Cl 1.04-4.52), and harbouring anti-CagA and anti-VacA antibodies simultaneously (OR 3.09, 95% Cl 1.26-7.56), while the odds were significantly reduced for those with an anxiety score of 6 or more (OR 0.45, 95% Cl 0.21-0.99). Conclusion: The simultaneous presence of anti-CagA and anti-VacA antibodies enhanced the risk of ACG in European dyspeptic patients. Failure to discern diet and family history as risk factors for ACG may suggest that diet is homogeneous in Europe and that most of the risk factors for ACG identified so far are identical to risk factors for H pylori infection

    The Beatiful study:randomized trial of Ivrabradine inpatients with stable coronary artery diseaseand left venricular systolic dysfunction -baseline characteristics of the study population

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    Objectives: Ivabradine is a selective heart rate-lowering agent that acts by inhibiting the pacemaker current I f in sinoatrial node cells. Patients with coronary artery disease and left ventricular dysfunction are at high risk of death and cardiac events, and the BEAUTIFUL study was designed to evaluate the effects of ivabradine on outcome in such patients receiving optimal medical therapy. This report describes the study population at baseline. Methods: BEAUTIFUL is an international, multicentre, randomized, double-blind trial to compare ivabradine with placebo in reducing mortality and cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction (ejection fraction ! 40%). Results: A total of 10,917 patients were randomized. At baseline, their mean age was 65 years, 83% were male, 98% Caucasian, 88% had previous myocardial infarction, 37% had diabetes, and 40% had metabolic syndrome. Mean ejection fraction was 32% and resting heart rate was 71.6 bpm. Concomitant medications included beta-blockers (87%), renin-angiotensin system agents (89%), antithrom-botic agents (94%), and lipid-lowering agents (76%). Conclusions: Main results from BEAUTIFUL are expected in 2008, and should show whether ivabradine, on top of optimal medical treatment, reduces mortality and cardiovascular events in this population of high-risk patients

    The prognosis and main prognostic indicators of Guillain-Barré syndrome. A multicentre prospective study of 297 patients

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    To assess the prognosis of the Guillain-Barré syndrome and identify the main prognostic indicators, 297 patients with Guillain-Barré syndrome recruited through a network of Italian centres were followed up for 24 months or until clinical recovery, whichever was earliest. For each patient the time to plateau, improvement, clinical recovery, or death was calculated, and prognostic indicators (age, sex, antecedent events, disability at admission and nadir, electrophysiological patterns) and treatments were noted. The mean duration of follow-up was 309 days. During this period, 212 patients (71%) recovered, 48 (16%) had residua and 33 (11%) died. The mean times to nadir, improvement and clinical recovery were 12, 28 and 200 days. Using life-tables and survival curves, the cumulative probability of achieving the plateau of symptoms was 73% by 1 week and 98% by 4 weeks. Improvement started during the first week in 36% of cases and within 4 weeks in 85%. The rates of clinical recovery at 1 and 4 weeks, 6, 12 and 24 months were 4, 24, 57, 70 and 82%, respectively. The chance of recovery was significantly affected by age, antecedent gastroenteritis, disability, electrophysiological signs of axonopathy, latency to nadir and duration of active disease. The main treatments did not seem to affect the chance of recovery

    Intraocular pressure-lowering effect of latanoprost monotherapy versus latanoprost or pilocarpine in combination with timolol: a randomized, observed-masked multicenter study in patient with open-angle glaucoma

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    PURPOSE: To compare intraocular pressure (IOP) after adding either latanoprost or pilocarpine to timolol treatment or switching to latanoprost monotherapy in glaucomatous eyes in which IOP was inadequately controlled with timolol. METHODS: This 6-month randomized study comprised 148 patients with primary open-angle or pseudoexfoliation glaucoma, which was inadequately controlled with topical beta-adrenergic antagonists. After a 2- to 4-week run-in period with timolol 0.5% twice daily, patients were assigned in randomized fashion to three study groups: one group received add-on therapy of latanoprost 0.005% once daily, the second group received add-on therapy of pilocarpine 2% three times daily, and the third group switched to latanoprost 0.005% once daily. Mean diurnal IOP was measured at baseline and after 3 and 6 months of treatment. RESULTS: At 6 months, 128 patients had completed the study. Diurnal IOP was significantly reduced from baseline in all groups. Adding latanoprost to timolol treatment reduced diurnal IOP by 6.1+/-0.3 mmHg (-28%), adding pilocarpine to timolol treatment reduced diurnal IOP by 4.2+/-0.3 mmHg (-19%), and switching from timolol to latanoprost monotherapy reduced diurnal IOP by 5.5+/-0.3 mmHg (-25%). CONCLUSION: A significantly greater reduction in diurnal IOP was achieved after addition of latanoprost than after addition of pilocarpine in patients in whom IOP was not adequately controlled with timolol alone. Further, the results of this study indicate that a switch to latanoprost monotherapy can be attempted before combination treatment is initiated
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