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Objective: The aim of this paper is to critically re-appraise the published trials assessing amitriptyline for migraine prophylaxis. Methods: We report our methods and results following the Preferred Reporting Items for Systematic Reviews (PRISMA), by searching MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov for randomized trials of pharmacologic treatments for migraine prophylaxis. We included randomized trials that compared amitriptyline with placebo for migraine prophylaxis in adults. Our outcomes of interest were informed by the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) and include the proportion of patients who experience a 50% or more reduction in migraine days per month, migraine days per month, and adverse events leading to discontinuation. We assessed risk of bias by using a modified Cochrane RoB 2.0 tool and the certainty of evidence by using the GRADE approach. Results: Our search yielded 10.826 unique records, of which three trials (n = 622) were eligible for data synthesis and analysis. We found moderate certainty evidence that amitriptyline increases the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo (relative risk: 1.60 (95% CI 1.17 to 2.19); absolute risk difference: 165 more per 1,000 (95% CI 47 more to 327 more). We found moderate certainty evidence that amitriptyline increases the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.05 (95% CI 0.01 to 0.10); absolute risk difference: 50 more per 1,000 (95% CI 10 more to 100 more). Conclusions: Our meta-analysis showed that amitriptyline may have a prophylactic role in migraine patients, however these results are far from robust. This warrants further large-scale research to evaluate the role of amitriptyline in migraine prevention. [ABSTRACT FROM AUTHOR]

Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement. [ABSTRACT FROM AUTHOR]

Background: Triptans are migraine-specific acute treatments. A well-accepted definition of triptan failure is needed in clinical practice and for research. The primary aim of the present Consensus was to provide a definition of triptan failure. To develop this definition, we deemed necessary to develop as first a consensus definition of effective treatment of an acute migraine attack and of triptan-responder. Main body: The Consensus process included a preliminary literature review, a Delphi round and a subsequent open discussion. According to the Consensus Panel, effective treatment of a migraine attack is to be defined on patient well-being featured by a) improvement of headache, b) relief of non-pain symptoms and c) absence of adverse events. An attack is considered effectively treated if patient's well-being, as defined above, is restored within 2 hours and for at least 24 hours. An individual with migraine is considered as triptan-responder when the given triptan leads to effective acute attack treatment in at least three out of four migraine attacks. On the other hand, an individual with migraine is considered triptan non-responder in the presence of failure of a single triptan (not matching the definition of triptan-responder). The Consensus Panel defined an individual with migraine as triptan-resistant in the presence of failure of at least 2 triptans; triptan refractory, in the presence of failure to at least 3 triptans, including subcutaneous formulation; triptan ineligibile in the presence of an acknowledged contraindication to triptan use, as specified in the summary of product characteristics. Conclusions: The novel definitions can be useful in clinical practice for the assessment of acute attack treatments patients with migraine. They may be helpful in identifying people not responding to triptans and in need for novel acute migraine treatments. The definitions will also be of help in standardizing research on migraine acute care. [ABSTRACT FROM AUTHOR]

Background: Due to the COVID-19 pandemic, matches and soccer-specific training were suspended for several weeks, matches after resumption were congested, and substitutions per team and game increased from three to five. Objective: The aim of this review was to examine possible differences in physical match performance and injuries between before and after the COVID-19 induced break of matches and training in professional male European soccer leagues during the 2019/2020 season. Methods: A systematic search identified all scientifically peer-reviewed publications involving elite male soccer players competing in the European leagues which reported physical match performance variables such as total running distance and running distance at different speed zones and/or injury parameters pre- and post-COVID-19 induced break. Results: In total, 11 articles were included, which were coming from German Bundesliga, Polish Ekstraklasa, Croatian HNL, Spanish La Liga, and Italian Serie A. In all studies investigating the German Bundesliga, most parameters of physical match performance remained unaffected (0.08 ≤ p ≤ 0.82; − 0.15 ≤ ES 0.15), while studies investigating the Polish Ekstraklasa (p ≤ 0.03; − 0.27 ≤ ES − 0.18), Croatian HNL (p ≤ 0.04; − 1.42 ≤ ES ≤ 1.44), Spanish La Liga (p ≤ 0.017; − 0.32 ≤ ES ≤ 5.5), and Italian Serie A (p ≤ 0.014; − 1.01 ≤ ES 0.24) showed a decrease in most parameters of physical match performance after the COVID-19 break. Injury rates were only investigated by studies targeting the German Bundesliga and Italian Serie A. In the majority of studies (3 out of 4 studies), there occurred no difference in injuries between pre- and post-COVID-19 break (p > 0.05; ES = N/A). Conclusion: Results indicate that Bundesliga teams maintained physical match performance during the 9-weeks break in matches and 3-weeks break in group training, whereas a longer match and group training interruption up to 15 weeks and 8 weeks, respectively, in the other leagues appeared to lead to a decreased physical match performance. Regarding injuries, we speculate that the increase in substitutions from 3 to 5 substitutions per game might prevent an increase in injury occurrence during matches. The underlying studies' results provide hints for possible upcoming unexpected interruptions with respect to optimal physical preparations for the resumption of matches and a congested schedule to maintain physical match performance, or for possible rule changes such as 5 instead of 3 substitutions to avoid physical overload during congested match schedules. [ABSTRACT FROM AUTHOR]

Several data indicate that migraine, especially migraine with aura, is associated with an increased risk of ischemic stroke and other vascular events. Of concern is whether the risk of ischemic stroke in migraineurs is magnified by the use of hormonal contraceptives. As migraine prevalence is high in women of reproductive age, it is common to face the issue of migraine and hormonal contraceptive use in clinical practice. In this document, we systematically reviewed data about the association between migraine, ischemic stroke and hormonal contraceptive use. Thereafter a consensus procedure among international experts was done to develop statements to support clinical decision making, in terms of cardiovascular safety, for prescription of hormonal contraceptives to women with migraine. Overall, quality of current evidence regarding the risk of ischemic stroke in migraineurs associated with the use of hormonal contraceptives is low. Available data suggest that combined hormonal contraceptive may further increase the risk of ischemic stroke in those who have migraine, specifically migraine with aura. Thus, our current statements privilege safety and provide several suggestions to try to avoid possible risks. As the quality of available data is poor further research is needed on this topic to increase safe use of hormonal contraceptives in women with migraine. [ABSTRACT FROM AUTHOR]