bluuebunny/crossref_metadata_2025_split huggingface dataset:
An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules
Authors: Lalova Teodora , Negrouk Anastassia , Dollé Laurent , Bekaert Sofie , Debucquoy Annelies , Derèze Jean-Jacques , Valcke Peggy , Kindt Els J. , Huys Isabelle 
Published: January 2021

AbstractThis contribution aims to present in a clear and concise manner the intricate legal framework for biobank research in Belgium. In Part 1, we describe the Belgian biobank infrastructure, with a focus on the concept of biobank. In Part 2, we provide an overview of the applicable legal framework, namely the Act of 19 December 2008 on Human Body Material (HBM), and its amendments. Attention is given to an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health (FAMPH). Furthermore, we delineate the interplay with relevant data protection rules. Part 3 is dedicated to the main research oversight bodies in the field of biobanking. In Part 4, we provides several examples of the ‘law in context’. In particular, we discuss issues pertaining to presumed consent, processing of personal data associated with HBM, and information provided to the donor of HBM. Finally, Part 5 and 6 addresses the impact of the EU General Data Protection Regulation (GDPR), suggests lines for further research, and outline the future possibilities for biobanking in Belgium.
Research Biobanking, Personal Data Protection and Implementation of the GDPR in France
Authors: Chassang Gauthier , Hisbergues Michael , Rial-Sebbag Emmanuelle 
Published: January 2021

AbstractSince 1978 and the initial French data protection law (Loi n°78-17 du 6 Janvier 1978), consecutive modifications regarding the protection of personal health data, especially in 2004, 2016 and 2018, set up a strict legal regime for processing sensitive personal data, including for research purposes. In recent years, French law has evolved proactively and in parallel with the work of the European Union (EU) on the preparation of what became the General Data Protection Regulation (GDPR), which has been in force since May 2018. This Chapter performs a state-of-art analysis (as of 1 July 2019) of the French legal framework for research biobanks and data protection rules applying to biobanking, in particular those related to data subjects’ rights and Article 89 of the GDPR. Firstly, it provides updated information about the national landscape of active research biobanks in France (Sect. 1). Secondly, it explores how the French law embodies the developments brought by the GDPR and how it envisages individuals’ rights in the context of research biobanking (Sects. 2 and 3). Thirdly, this Chapter analyses existing and potential national exemptions to individuals’ rights, including with regard to Article 89 GDPR, and how France conceives of processing activities of ‘public interest’ (Sect. 4). Finally, the authors address ongoing debates around bioethics law in France and argue for the creation of a specific Act focused on biobanking as a means of integrating, clarifying and developing not only data protection rules but also other activities related to samples, human or not, in a unique, operational and compact act (Sect. 5).
Biobanks and GDPR: A Look at the Portuguese Panorama
Authors: Barbosa Carla , da Costa Andrade Andreia 
Published: January 2021

AbstractThe need for the existence of biobanks for health research purposes is something of which government authorities have been aware for several years. One year after the full entry into force of the GDPR, the Portuguese legislature has finally passed the law that ensures the full implementation of the data protection regime’s points left open by the European legislature. However, Portugal has also in place a range of legislation regulating the establishment and functioning of biobanks. The regulation of biobanks for research purposes imposes special protection duties on scientific research activity in which biological samples and associated data are used in order to guarantee protection of privacy and confidentiality.
Biobank and Biomedical Research: Responsibilities of Controllers and Processors Under the EU General Data Protection Regulation
Authors: Nordberg Ana 
Published: January 2021

AbstractBiobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk of privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonisation, resulting in a framework in which the specific duties and obligations of entities processing personal data—controllers and processors—were defined. Biobanks, in the exercise of their functions, assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules in the light of Article 89 GDPR, which creates safeguards and derogations relating to ‘processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when a biobank should be considered controller and processor; and what are the main duties of biobanks as data controllers and processors and options for compliance.
Safeguards and Derogations Relating to Processing for Scientific Purposes: Article 89 Analysis for Biobank Research
Authors: Duguet Anne-Marie , Herveg Jean 
Published: January 2021

AbstractWhen complying with appropriate safeguards, the processing of personal data for scientific research under the GDPR benefits from a special regime which is of interest for biobank research. On the one hand, under this condition, the further processing of personal data will not be incompatible with the initial purposes for which the data were originally collected and processed and it allows for retaining data for longer periods of time for scientific research. Complying with this condition is a condition to lift the prohibition to process special categories of personal data in the context of scientific research. On the other hand, complying with this condition makes it possible to derogate to some extent to several data subjects’ rights such as the right of access, the right to rectification, the right to the restriction of processing and the right to object to the processing.Possible safeguards range from specific procedures to support the exercise of data subjects’ rights to the use of anonymous data or (where necessary) of pseudonymised data, the appointment of a data protection officer, enforcing a procedure to ensure a feedback to data subjects on the results of the research, requiring specific professional accreditations, creating a specific supervisory body for the biobank research, or the creation of a specific Code of conduct for biobank research activities.This double regime under the GDPR is finally compared with the 2009 OECD Guidelines in biobanks and genetic research databases.
Brexit and Biobanking: GDPR Perspectives
Authors: Phillips Andelka M. , Hervey Tamara K. 
Published: January 2021

AbstractAt the time we wrote this chapter, we undertook the almost impossible task of providing a legal analysis of an event (Brexit) that had not happened and might never have happened. This chapter nonetheless contributes to the edited collection in that it reports on the then legal position in the UK, and presents an analysis of two possible immediate post-Brexit legal futures, for data protection law as applicable to biobanking in the UK. These post-Brexit futures are the position if the draft Withdrawal Agreement is ratified and comes into force, and the position if it does not (a so-called ‘No Deal’ Brexit). The chapter concludes with some thoughts on possible longer term futures. The main message is the deep uncertainties surrounding Brexit and what it means in both legal form and in practice.
Individualizing Workplace Learning with Digital Technologies
Authors: Barabasch Antje , Keller Anna 
Published: January 2021

AbstractVocational education and training (VET) at Swiss enterprises includes the work with various digital technologies. They ease administration of work hours, work tasks, evaluations or log book remarks; they support communication with peers, co-workers and trainers; and they come in handy for idea development and creative work. Overarching trends in terms of changing learning cultures in apprenticeship training, such as individualization, flexibilization, self-organized learning, project work or coaching, support the introduction of these technologies and also benefit from them. Based on three in-depth case studies, results on the usage and impact of digital technologies will be presented. This chapter addresses the following research questions: Which digital tools are used in workplace training? What are potential benefits and extended justifications for the use of digital tools? How are modern learning cultures impacting the use of digital tools? We will outline how and where digital technologies are used at the workplace in apprenticeship training, why management has introduced them and how apprentices and their trainers benefit from it. Based on our findings, we will draw conclusions about how learning cultures are influencing the use of technologies and vice versa how the introduction of these technologies shapes innovative learning cultures in VET.
Defending Union Values in Judicial Proceedings. On How to Turn Article 2 TEU into a Judicially Applicable Provision
Authors: Spieker Luke Dimitrios 
Published: January 2021

AbstractThis chapter centres on the question of how to address violations of EU values in judicial proceedings before the Court of Justice. Instead of relying on fundamental freedoms, EU secondary legislation or the Charter, this chapter explores a more promising path—engaging with Article 2 TEU itself. Yet this path rests on a crucial premise: the judicial applicability of the values enshrined in Article 2 TEU. Such a judicial applicability is far from self-evident and needs to be carefully construed. Based on recent jurisprudential developments, this chapter will propose ways to operationalise Article 2 TEU without curtailing its unrestricted scope of application. The judgments ofAssociação Sindical dos Juízes Portugueses,Minister for Justice and Equality(L.M.) andCommission v. Polandwill be at the heart of this contribution.
Thrombosis in Rheumatological Diseases
Authors: Bashal Fozya 
Published: January 2021

AbstractVenous thromboembolism (VTE) is a disease of blood coagulation that occurs in the veins, most often in the calf veins first, from where it may extend and cause deep vein thrombosis (DVT) or pulmonary embolism (PE). The first described case of venous thrombosis that we know of dates back to the thirteenth century, when deep vein thrombosis was reported in the right leg of a 20-year-old man [1].
Classification Criteria and Clinical Practice Guidelines for Rheumatic Diseases
Authors: Hassan Rola , Faruqui Hanan , Alquraa Reem , Eissa Ayman , Alshaiki Fatma , Cheikh Mohamed 
Published: January 2021

AbstractRheumatic diseases have many classification criteria and management guidelines that are continuously being updated in order to improve the quality of healthcare provision. With these ever-evolving criteria and guidelines, practicing clinicians need an easy way to get to the core of these updates and to retain them in an easy and memorable way. Classification criteria are meant to differentiate between similar diseases and also to confirm or rule out a certain disease based on inclusion and exclusion criteria. The diagnosis of rheumatic diseases can be challenging since many clinical signs and symptoms as well as many laboratory markers are not specific and can be positive in many diseases.
Approaching the self-dual point of the sinh-Gordon model
Authors: Konik Robert , Lájer Márton , Mussardo Giuseppe 
Published: January 2021

Abstract
One of the most striking but mysterious properties of the sinh-Gordon model (ShG) is the b → 1/b self-duality of its S-matrix, of which there is no trace in its Lagrangian formulation. Here b is the coupling appearing in the model’s eponymous hyperbolic cosine present in its Lagrangian, cosh(bϕ). In this paper we develop truncated spectrum methods (TSMs) for studying the sinh-Gordon model at a finite volume as we vary the coupling constant. We obtain the expected results for b ≪ 1 and intermediate values of b, but as the self-dual point b = 1 is approached, the basic application of the TSM to the ShG breaks down. We find that the TSM gives results with a strong cutoff Ec dependence, which disappears according only to a very slow power law in Ec. Standard renormalization group strategies — whether they be numerical or analytic — also fail to improve upon matters here. We thus explore three strategies to address the basic limitations of the TSM in the vicinity of b = 1. In the first, we focus on the small-volume spectrum. We attempt to understand how much of the physics of the ShG is encoded in the zero mode part of its Hamiltonian, in essence how ‘quantum mechanical’ vs ‘quantum field theoretic’ the problem is. In the second, we identify the divergencies present in perturbation theory and perform their resummation using a supra-Borel approximate. In the third approach, we use the exact form factors of the model to treat the ShG at one value of b as a perturbation of a ShG at a different coupling. In the light of this work, we argue that the strong coupling phase b > 1 of the Lagrangian formulation of model may be different from what is naïvely inferred from its S-matrix. In particular, we present an argument that the theory is massless for b > 1.
The Niederschlag fluorite-(barite) deposit, Erzgebirge/Germany—a fluid inclusion and trace element study
Authors: Haschke Sebastian , Gutzmer Jens , Wohlgemuth-Ueberwasser Cora C. , Kraemer Dennis , Burisch Mathias 
Published: January 2021

AbstractThe Niederschlag fluorite-barite vein deposit in the Western Erzgebirge, Germany, has been actively mined since 2013. We present the results of a first comprehensive study of the mineralogy, petrography, fluid inclusions, and trace element geochemistry of fluorite related to the Niederschlag deposit. Two different stages of fluorite mineralization are recognized. Stage I fluorite is older, fine-grained, associated with quartz, and forms complex breccia and replacement textures. Conversely, the younger Stage II fluorite is accompanied by barite and often occurs as banded and coarse crystalline open-space infill. Fluid inclusion and REY systematics are distinctly different for these two fluorite stages. Fluid inclusions in fluorite I reveal the presence of a low to medium saline (7–20% eq. w (NaCl+CaCl2)) fluid with homogenization temperatures of 140–180 °C, whereas fluorite II inclusions yield distinctly lower (80–120 °C) homogenization temperatures with at least two high salinity fluids involved (18–27% eq. w (NaCl+CaCl2)). In the absence of geochronological data, the genesis of the earlier generation of fluorite-quartz mineralization remains enigmatic but is tentatively related to Permian magmatism in the Erzgebirge. The younger fluorite-barite mineralization, on the other hand, has similarities to many fluorite-barite-Pb-Zn-Cu vein deposits in Europe that are widely accepted to be related to the Mesozoic opening of the northern Atlantic Ocean.
Coffee Berry Borer (Hypothenemus hampei) and its role in the evolutionary diversification of the coffee market
Authors: Toro-Zapata Hernán Darío , Trujillo-Salazar Carlos Andrés , Dercole Fabio , Olivar-Tost Gerard 
Published: January 2021

AbstractThe Coffee Berry Borer (CBB) is the main pest that affects coffee crops around the world, causing major economic losses and diminishing beverage quality. A mathematical model is formulated, from the perspective of the Adaptive Dynamics (AD) framework, to describe the evolution of coffee quality as a continuous differentiating attribute related to the mix of healthy and bored coffee. The study involves three stages: first, an agro-ecological model describes coffee production and growth of the CBB population prior to the processing of different qualities of coffee; second, a market model describes the competition between different blends of standard and special coffee; finally, the AD canonical equation is derived to describe the evolution of coffee quality resulting from innovations in the quality attribute filtered by market competition. Interestingly, AD allows to derive conditions for the emergence of diversity, i.e., the establishment of a second type of coffee that coexists with the former and, similarly, for subsequent branching in the quality attributes. The full model provides insights on the impact of CBB control strategies on the long-term market structure. Specifically, a strong control aimed at increasing coffee quality may impoverish the market diversity, independently of the consumers’ budget limitations and corresponding preference for either high or low quality.
Differential effects of sex on longitudinal patterns of cognitive decline in Parkinson’s disease
Authors: Bakeberg Megan C. , Gorecki Anastazja M. , Kenna Jade E. , Jefferson Alexa , Byrnes Michelle , Ghosh Soumya , Horne Malcolm K. , McGregor Sarah , Stell Rick , Walters Sue , Chivers Paola , Winter Samantha J. , Mastaglia Frank L. , Anderton Ryan S. 
Published: January 2021

AbstractBackgroundCognitive impairment is an important and diverse symptom of Parkinson’s disease (PD). Sex is a purported risk variable for cognitive decline in PD, but has not been comprehensively investigated.ObjectivesThis cross-sectional and longitudinal study examined sex differences in global and domain-specific cognitive performance in a large PD cohort.MethodsCognitive function was evaluated using the Addenbrooke’s Cognitive Examination in 392 people with PD (PwP) from the Australian Parkinson’s Disease Registry. The influence of sex on domain-specific cognitive performance was investigated using covariate-corrected generalised linear models. In a repeated measures longitudinal subset of 127 PwP, linear mixed models were used to assess the impact of sex on cognition over time, while accounting for covariates.ResultsCross-sectional-corrected modelling revealed that sex was significantly predictive of cognitive performance, with males performing worse than females on global cognition, and memory and fluency domains. Longitudinally, sex was significantly predictive of cognitive decline, with males exhibiting a greater reduction in global cognition and language, whereas females showed a greater decline in attention/orientation, memory and visuospatial domains, despite starting with higher baseline scores. At follow-up, a significantly higher proportion of males than females fulfilled criteria for mild cognitive impairment or PD dementia.ConclusionsSex was revealed as a significant determinant of overall cognitive performance as well as specific cognitive domains, with a differential pattern of decline in male and female participants. Such sex-specific findings appear to explain some of the heterogeneity observed in PD, warranting further investigation of mechanisms underlying this sexual dimorphism.
Robotic Complete Mesocolic Excision (CME) is a safe and feasible option for right colonic cancers: short and midterm results from a single-centre experience
Authors: Siddiqi Najaf , Stefan Samuel , Jootun Ravish , Mykoniatis Ioannis , Flashman Karen , Beable Richard , David Gerald , Khan Jim 
Published: January 2021

Abstract
Background
Complete mesocolic excision (CME) for right colon cancers has traditionally been an open procedure. Surgical adoption of minimal access CME remains limited due to the technical challenges, training gaps and lack of level-1 data for proven benefits. Currently there is limited published data regarding the clinical results with the use of robotic CME surgery. Aim To report our experience, results and techniques, highlighting a clinical and oncological results and midterm oncological outcomes for robotic CME.

Aim
To report our experience, results and techniques, highlighting a clinical and oncological results and midterm oncological outcomes for robotic CME.

Methods
All patients undergoing standardised robotic CME technique with SMV first approach between January 2015 and September 2019 were included in this retrospective review of a prospectively collected database. Patient demographics, operative data and clinical and oncological outcomes were recorded.

Results
Seventy-seven robotic CME resections for right colonic cancers were performed over a 4-year period. Median operative time was 180 (128–454) min and perioperative blood loss was 10 (10–50) ml. There were 25 patients who had previous abdominal surgery. Median postoperative hospital stay was 5 (3–18) days. There was no conversion to open surgery in this series. Median lymph node count was 30 (10–60). Three (4%) patients had R1 resection. There was one (1%) local recurrence in stage III disease and 4(5%) distal recurrence in stage II and stage III. There was no 30- or 90-day mortality. Three-year disease-free survival was 100%, 91.7% and 92% for stages I, II and III, respectively. Overall survival was 94%.

Conclusions
Robotic CME is feasible, effective and safe. Good oncological results and improved survival are seen in this cohort of patients with a standardised approach to robotic CME.
Onkologische Prävention – inwiefern ist die Ernährung entscheidend?
Authors: Rohrmann Sabine , Hermann Silke 
Published: January 2021

Zusammenfassung
Hintergrund
Krebs ist eine der häufigsten chronischen Erkrankungen in Deutschland und wird zu einem beträchtlichen Teil durch veränderbare Risikofaktoren verursacht.

Fragestellung
Welche Assoziationen gibt es zwischen Ernährungsfaktoren und einer Krebsentstehung?

Material und Methode
Narratives Review, das zur Beantwortung der Fragestellung vor allem systematische Übersichtsarbeiten und Metaanalysen heranzieht.

Ergebnisse
Derzeit werden alkoholische Getränke, rotes und verarbeitetes Fleisch, Salz und die glykämische Last als Risikofaktoren für zumindest einzelne Krebslokalisationen angesehen, während Obst, Gemüse, Ballaststoffe, Kaffee und teils Milch und Milchprodukte als protektive Faktoren gelten. Im Zusammenhang mit Ernährung gilt Adipositas als wichtigster Risikofaktor, der zudem selbst durch Ernährungsfaktoren beeinflusst wird. Zusammengenommen sind diese Faktoren für etwa 18 % aller Krebserkrankungen verantwortlich.

Schlussfolgerungen
Auch wenn Ernährungsfaktoren nicht an das Präventionspotenzial von Rauchen heranreichen, können sie das Risiko der Tumorentstehung, vor allem im Verdauungsbereich, beträchtlich reduzieren.