6 research outputs found

    D4.3 – Initial version of game applications for scenario pilots

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    This intermediate report provides an overview of the current versions of the RAGE games made using the RAGE assets for the first round of pilot testing and formative evaluation. The document serves as internal communication and discussion in RAGE among game companies and asset developers together with case owners and evaluators. Whilst detailed description of the design of the games, together with their learning outcomes and piloting can be found in D4.2 and D5.1, updates and changes to the designs, game flow and use of assets are included here.This study is part of the RAGE project. The RAGE project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 644187. This publication reflects only the author's view. The European Commission is not responsible for any use that may be made of the information it contains

    Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

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    Background Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.Methods We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (>= 200 mg/day) and furosemide (>= 25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials. gov, number NCT01288794.Findings From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0.028), resulting in a 38% reduction in the mortality hazard ratio (0.62 [95% CI 0.40-0.95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events.Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. (C) 2018 Elsevier Ltd. All rights reserved
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