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Tau PET and relative cerebral blood flow in dementia with Lewy bodies : A PET study

Purpose: Alpha-synuclein often co-occurs with Alzheimer's disease (AD) pathology in Dementia with Lewy Bodies (DLB). From a dynamic [18F]flortaucipir PET scan we derived measures of both tau binding and relative cerebral blood flow (rCBF). We tested whether regional tau binding or rCBF differed between DLB patients and AD patients and controls and examined their association with clinical character

ELSI Implications of Prioritizing Biological Therapies in the Times of COVID-19

There is no doubt that COVID-19 will have a substantial impact on access to biologics and biosimilar uptake, as well as on the related ethical, legal, and social dimensions of prioritization decisions. This holds especially true for Denmark and European markets, where governments are expected to cover most of the pharmaceutical needs of their citizens and where the crisis has been leading to an im

Knowledge transfer for large scale vaccine manufacturing

As the world rushes to identify safe and effective vaccines and therapeutics to counter the COVID-19 epidemic, attention is turning to the next step: manufacturing these products at enormous scale. To speed up the process, firms are even es-tablishing manufacturing capacity “at risk,” before products receive regulatory approval (1). Yet for at least some complex COVID-19 vaccines and biological th

Knowledge for policy-making in times of uncertainty: the case of autonomous vehicle model results

There has been a rapid rise in papers modelling the impacts of autonomous vehicles. Drawing on a review of this literature, we analyse and discuss the messages conveyed by these studies from a policy-making perspective. An overview of the studies is provided to highlight the different policy frames. We consider the roles that modelling knowledge should have in policy-making in the context of unsta

AIRR Data Under the E.U. Trade Secrets Directive: Aligning Scientific Practices with Commercial Realities

Whether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike. One such technology—adaptive immune receptor repertoire sequencing, or AIRR-seq—raises difficult questions concerning what information is and should be protected under the new Directive, and how to be

Book introduction: An Appraisal of the EU Directive on Trade Secrets

The EU Trade Secrets Directive (‘the Directive’) has standardized the national laws in EU member states for the protection of trade secrets. For the first time, a harmonised definition of what constitutes a ‘trade secret’ is established as well as common measures aimed at preventing the misappropriating of trade secrets and rules for procedures and sanctions.The adoption of the Directive reflects

The harmonization and protection of trade secrets in the EU: – An Appraisal of the EU Directive

The growing significance of trade secrets (TS) in today's society and business has unleashed an unprecedented boom in litigation, legislation, and in media and scholarly attention. Many factors contribute to this development, such as the rise of digitalization & artificial intelligence, increasing mobility, a changing intellectual property (IPR) landscape, the greater flexibility and applicabi

When does stand-alone software qualify as a medical device in the European Union?: The CJEU decision in SNITEM and what it implies for the next generation of medical devices

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the softwar

Ethical and Legal Challenges of Artificial Intelligence-Driven Health Care

This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be fo

The European Artificial Intelligence Strategy: Implications and Challenges for Digital Health

In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, p

(Anti-)deuteron production in pp collisions at √s=13TeV

The study of (anti-)deuteron production in pp collisions has proven to be a powerful tool to investigate the formation mechanism of loosely bound states in high-energy hadronic collisions. In this paper the production of (anti-)deuterons is studied as a function of the charged particle multiplicity in inelastic pp collisions at s=13 TeV using the ALICE experiment. Thanks to the large number of acc

Polygenic risk scores and breast and epithelial ovarian cancer risks for carriers of BRCA1 and BRCA2 pathogenic variants

PURPOSE: We assessed the associations between population-based polygenic risk scores (PRS) for breast (BC) or epithelial ovarian cancer (EOC) with cancer risks for BRCA1 and BRCA2 pathogenic variant carriers. METHODS: Retrospective cohort data on 18,935 BRCA1 and 12,339 BRCA2 female pathogenic variant carriers of European ancestry were available. Three versions of a 313 single-nucleotide polymorph

The Importance of the Physical Environment to Support Person-Centered Rehabilitation in the Home

This chapter aims to contribute to an understanding of the physical environment as an important part of the rehabilitation process for patients recovering from a stroke who rehabilitate at home. To further develop evidence-based care models for rehabilitation at home and incorporate person-environment dynamics, an understanding of how environmental factors relate to everyday life and recovering at

Search for direct production of electroweakinos in final states with missing transverse momentum and a Higgs boson decaying into photons in pp collisions at √s = 13 TeV with the ATLAS detector

A search for a chargino-neutralino pair decaying via the 125 GeV Higgs boson into photons is presented. The study is based on the data collected between 2015 and 2018 with the ATLAS detector at the LHC, corresponding to an integrated luminosity of 139 fb−1 of pp collisions at a centre-of-mass energy of 13 TeV. No significant excess over the expected background is observed. Upper limits at 95% conf