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- Caronna, Edoardo, et al.
(författare)
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Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world
- 2024
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Ingår i: JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY. - 0022-3050 .- 1468-330X.
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Tidskriftsartikel (refereegranskat)abstract
- Background Anti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who might respond. This study aimed to investigate clinical factors associated with good and excellent response to anti-CGRP MAbs at 6 months. Methods European multicentre, prospective, real-world study, including high-frequency episodic or chronic migraine (CM) patients treated since March 2018 with anti-CGRP MAbs. We defined good and excellent responses as >= 50% and >= 75% reduction in monthly headache days (MHD) at 6 months, respectively. Generalised mixed-effect regression models (GLMMs) were used to identify variables independently associated with treatment response. Results Of the 5818 included patients, 82.3% were females and the median age was 48.0 (40.0-55.0) years. At baseline, the median of MHD was 20.0 (14.0-28.0) days/months and 72.2% had a diagnosis of CM. At 6 months (n=4963), 56.5% (2804/4963) were good responders and 26.7% (1324/4963) were excellent responders. In the GLMM model, older age (1.08 (95% CI 1.02 to 1.15), p=0.016), the presence of unilateral pain (1.39 (95% CI 1.21 to 1.60), p<0.001), the absence of depression (0.840 (95% CI 0.731 to 0.966), p=0.014), less monthly migraine days (0.923 (95% CI 0.862 to 0.989), p=0.023) and lower Migraine Disability Assessment at baseline (0.874 (95% CI 0.819 to 0.932), p<0.001) were predictors of good response (AUC of 0.648 (95% CI 0.616 to 0.680)). These variables were also significant predictors of excellent response (AUC of 0.691 (95% CI 0.651 to 0.731)). Sex was not significant in the GLMM models. Conclusions This is the largest real-world study of migraine patients treated with anti-CGRP MAbs. It provides evidence that higher migraine frequency and greater disability at baseline reduce the likelihood of responding to anti-CGRP MAbs, informing physicians and policy-makers on the need for an earlier treatment in order to offer the best chance of treatment success.
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| 2. |
- Carraminana, Albert, et al.
(författare)
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Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV)
- 2019
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Ingår i: Journal of Cardiothoracic and Vascular Anesthesia. - : W B SAUNDERS CO-ELSEVIER INC. - 1053-0770 .- 1532-8422. ; 33:9, s. 2492-2502
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation. Design: International, multicenter, prospective, randomized controlled clinical trial. Setting: A network of university hospitals. Participants: The study comprises 1,380 patients scheduled for thoracic surgery. Interventions: The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation. Measurements and Main Results: Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients. (C) 2019 Published by Elsevier Inc.
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| 3. |
- Alay, Özgü, et al.
(författare)
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Monitoring and Analytics (Release B)
- 2021
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Rapport (refereegranskat)abstract
- This document describes the design and implementation of the 5GENESIS Monitoring & Analytics (M&A) framework in its Release B, developed within Task T3.3 of the project work plan. M&A Release B leverages and extends M&A Release A, which has been documented in the previous Deliverable D3.5 [1]. In particular, we present new features and enhancements introduced in this new Release compared to the Release A. We also report some examples of usage of the M&A framework, in order to showcase its integrated in the 5GENESIS Reference Architecture.
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| 4. |
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| 5. |
- Diaz Zayas, Almudena, et al.
(författare)
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A Modular Experimentation Methodology for 5G Deployments : The 5GENESIS Approach
- 2020
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Ingår i: Sensors. - : MDPI. - 1424-8220. ; 20:22
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Tidskriftsartikel (refereegranskat)abstract
- The high heterogeneity of 5G use cases requires the extension of the traditional per-component testing procedures provided by certification organizations, in order to devise and incorporate methodologies that cover the testing requirements from vertical applications and services. In this paper, we introduce an experimentation methodology that is defined in the context of the 5GENESIS project, which aims at enabling both the testing of network components and validation of E2E KPIs. The most important contributions of this methodology are its modularity and flexibility, as well as the open-source software that was developed for its application, which enable lightweight adoption of the methodology in any 5G testbed. We also demonstrate how the methodology can be used, by executing and analyzing different experiments in a 5G Non-Standalone (NSA) deployment at the University of Malaga. The key findings of the paper are an initial 5G performance assessment and KPI analysis and the detection of under-performance issues at the application level. Those findings highlight the need for reliable testing and validation procedures towards a fair benchmarking of generic 5G services and applications.
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| 6. |
- Emmelmann, Marc, et al.
(författare)
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Deliverable 6.2: Trials and experimentation (cycle 2)
- 2020
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Rapport (refereegranskat)abstract
- This deliverable presents the second cycle of trials and experimentation activities executed over 5GENESIS facilities. The document is the continuation of deliverable D6.1, in the sense that it captures tests carried out over the evolved infrastructures hosting 5GENESIS facilities following the methodology defined in D6.1. In this document 8 main KPIs and 4 application specific validation trials achieved, under 123 experiments that performed in total. The tests focus more on i) the evolved 5G infrastructure deployments that includes radio and core elements in non-standalone (NSA) deployment configurations based on commercial and open implementations, and ii) the use of Open 5GENESIS Suite for the execution of the tests.
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