bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cytoreductive stereotactic body radiotherapy (SBRT) and combination SBRT with immune checkpoint inhibitors (ICIs) in metastatic renal cell carcinoma
Authors: Peng Jonathan , Lalani Aly-Khan , Swaminath Anand 
Published: January 2021

Introduction: Preclinical evidence demonstrates the immunogenic potential of stereotactic body radiotherapy (SBRT). There is growing interest in investigating this interplay with the immune system in metastatic renal cell carcinoma (mRCC). Cytoreduction with SBRT and combination therapy with SBRT and checkpoint inhibitor immuno-oncology agents (IO) are two potential therapeutic strategies in mRCC. In this review, we summarize the current clinical evidence for the use of cytoreductive SBRT to primary kidney and combination SBRT with IO.
Methods: A literature review for articles and abstracts published between January 2000 and March 2020 was conducted through the PubMed, the American Society of Clinical Oncology (ASCO), and the American Society of Radiation Oncology (ASTRO) database. Evaluation of studies followed the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) criteria.
Results: A total of three articles for cytoreductive SBRT and one article and three abstracts for combination SBRT and IO in mRCC met inclusion criteria for this review. Evidence for SBRT to primary kidney is limited by small series and pilot studies. Outcomes vary widely due to small patient numbers and study heterogeneity. Local control ranges from 85–100% and one- and two-year overall survival ranges from 38–71% and 19é53%, respectively. Combination SBRT and IO are tolerable for patients with early data, suggesting grade 3–4 adverse event rates of 0–24%. Long-term survival data is not yet available.
Conclusions: Cytoreductive SBRT and combination SBRT with IO therapy represent promising treatment strategies in mRCC. The evidence for clinical benefit is currently limited and requires further study with well-designed, randomized, controlled trials.
El paisaje urbano en la narrativa española contemporánea: las novelas de Antonio Muñoz Molina
Authors: Sánchez Sempere Irene 
Published: January 2021

Arte y literatura —en particular la novela— encuentran en el paisaje urbano uno de sus referentes principales y, desde múltiples perspectivas, abordan frecuentemente temas que le son consustanciales: la problemática relación entre individuo y sociedad, la soledad y el anonimato entre la multitud, la libertad y el cosmopolitismo, la esperanza del inmigrante, el hacinamiento y el crimen, etc. En las últimas décadas se repite, además, la ficcionalización del espacio interior del autor o los personajes en la configuración de ese paisaje. Partiendo de los vínculos históricos entre ciudad y literatura, el presente trabajo resume la evolución del tratamiento literario de lo urbano para llegar a la novela española de las últimas décadas, en cuyo contexto elegimos el caso paradigmático de Antonio Muñoz Molina para ilustrar, analizando múltiples ejemplos de su obra, aquel diálogo ficcionalizado entre el entorno urbano y la subjetividad del narrador, siempre ilumina por la memoria y la imaginación.
The preeminent urban model generates heterogeneous area of exchange, coexistence and competition characteristic of our time. Art and literature –particularly, the novel– find one of their principal references in the urban landscape and, from multiple perspectives, they frequently tackle topics inherent in it: the problematic relation between the individual and society, the loneliness and anonymity among the crowd, freedom and cosmopolitanism, the hope of the immigrant, overcrowding and crime… The city in the modern novel gets to acquire its own voice and personality, as if it were just another character. And in recent decades, we have observed a new inflection: dismissing physical objectivity, many writers project their own subjectivity onto the urban environment, drawing a literary landscape in which “myth, invention and reality” are merged. The current work gives an account on this, providing the example of several Spanish novelists, Antonio Muñoz Molina in particular.
Identidad y delimitación textual del poema 29 de Ausiàs March
Authors: Martin Pascual Llúcia 
Published: January 2021

La poesía 29 de Ausiàs March Si com lo taur se’n va fuyt pel desert, formada por una única estrofa, es una de las más populares y difundidas de su Cancionero. Se conserva en la mayor parte de los testimonios manuscritos e impresos. Sin embargo, posiblemente debido a un error de copia, la poesía 29 se difundió junto con la 30, Vengut és temps que será conegut, como si de una sola composición se tratase. Este posible error coincide en una serie de testimonios. La hipótesis de una filiación entre los diferentes manuscritos y el tratamiento de la poesía en los impresos puede contribuir a conocer mejor la tradición textual. La redacción conjunta de las dos poesías se debe a un problema de transmisión pues por su temática no son textos relacionables. En este trabajo observaremos el comportamiento de los dos textos y las posibles razones de su localización conjunta, así como también la decisión de editarlas por separado.
The poem 29 by Ausiàs March, Si com lo taur se’n va fuyt pel desert, consisting of a single stanza, is one of the most popular and widespread of this author. It is preserved in most of the handwritten and printed testimonies. However, possibly due to a copy error, the poem 29 was spread together with the poem 30, Vengut és temps que será conegut, like a single composition. This possible error coincides in a series of testimonies. Perhaps, the relation between certain manuscripts and the presence of the poetry in the printed books can contribute to a better understanding of the textual tradition. The joint writing of the two poems is due to a problem of transmission because they are not relatable texts in terms of subject matter. In this work we will observe the behavior of the two texts and the possible reasons for their joint location, as well as the decision to edit them separately.
Intenciones de comportamiento, satisfacción y calidad percibida de los espectadores del Campeonato Asiático de Voleibol Masculino Sub-23 de 2017
Authors: Naghi-Pour Givi B. , Hossein Monazzami A. , Mohamadi Turkmani E. , Mirfallah Nassiri R. 
Published: January 2021

El objetivo de este estudio fue analizar las intenciones de comportamiento, la satisfacción y la calidad percibida de los espectadores del Campeonato Asiático de Voleibol Masculino Sub-23 de 2017. La muestra estuvo compuesta por 351 espectadores del evento. El instrumento utilizado fue un cuestionario fiable formado por cinco sub-cuestionarios sobre calidad del servicio, calidad del producto principal, satisfacción con el servicio, satisfacción con el juego e intenciones de comportamiento. El análisis estadístico se basó en ecuaciones estructurales y se realizó con el software WarpPLS versión 6. La calidad de los servicios tuvo un efecto significativo en la satisfacción con el servicio (β = 0,504; P <0,001). La calidad del producto principal tuvo un efecto significativo en la satisfacción con el juego (β = 0,658; P <0,001). Además, la satisfacción con el juego tuvo un efecto significativo sobre las intenciones de comportamiento (β = 0,514; P <0,001). Sin embargo, el efecto de la satisfacción con el servicio sobre las intenciones de comportamiento no fue significativo. Por ello, es recomendable que los organizadores de megaeventos deportivos consideren estos resultados con el fin de mejorar las intenciones de comportamiento, la satisfacción y la calidad percibida de los espectadores.
The aim of this study was to analyze behavioral intentions, satisfaction and perceived quality of the spectators of the 2017 Asian Men's U23 Volleyball Championship. The sample was composed of 351 spectators of the event. The instrument used was a reliable questionnaire with five sub-questionnaires about service quality, main product quality, service satisfaction, game satisfaction, and behavioral intentions. The statistical analysis was based on structural equations and it was carried out with the software WarpPLS version 6. The quality of services had a significant effect on service satisfaction (β=0.504, P<0.001). The core product quality had a significant effect on game satisfaction (β=0.658, P<0.001). Also, the game satisfaction had a significant effect on behavioral intentions (β=0.514, P<0.001). However, the effect of service satisfaction on behavioral intentions was not significant. Therefore, it is recommendable that the organizers of mega sport events consider these results in order to improve the behavioral intentions, satisfaction and perceived quality of the spectators.
Associations between maternal socioeconomic, psychosocial and seasonal factors, infant characteristics and human milk cortisol concentrations
Authors: Lindberg Matti , Nolvi Saara , Härkönen Juho , Aatsinki Anna‐Katariina , Karlsson Linnea , Karlsson Hasse , Uusitupa Henna‐Maria 
Published: January 2021

AbstractObjectivesGlucocorticoids are one component of human milk (HM) potentially affecting offspring development. Previous studies have identified various maternal, obstetric and socioeconomic characteristics that are associated with HM cortisol concentration but the literature is still scarce concerning these determinants in human populations. We aimed to identify which factors are linked with HM cortisol concentration at 2 months postpartum.MethodsWe analyzed data from 340 lactating Finnish mothers using ordinary least squares regression with log‐transformed HM cortisol concentration as the dependent variable. Potential predictors included obstetric and maternal factors (maternal age, parity status, delivery mode, gestational age, pre‐pregnancy obesity, and smoking in pregnancy), socioeconomic status (education and socioeconomic class), subjective economic well‐being, maternal psychosocial factors (postpartum depression and anxiety symptoms), infant sex and age, and HM sample characteristics (time of the day and season of the year at sample collection).ResultsThe strongest and most robust predictors were season of the year of sample collection and parity status. HM cortisol concentration was significantly higher for primiparas than multiparas. HM samples collected in summer showed significantly higher cortisol concentrations than those collected in winter, spring or autumn.ConclusionsThe findings suggest that parity and season of the year at sample collection may be important factors to control for when examining HM cortisol. The strongest and most robust associations were related to maternal and sample characteristics and not to socioeconomic and psychosocial distress. This may be related to the fact that the study was conducted in a low‐risk population.
Introduction
Authors: Slokenberga Santa , Tzortzatou Olga , Reichel Jane 
Published: January 2021

AbstractThe General Data Protection Regulation (GDPR) is already four years old legal instrument, with over two years of practical experience, yet, several central questions on its application, its importance in scientific research, rights of the data subjects, and obligations on the controllers and processors remain uncharted. In this edited volume, questions ranging from the meaning of the GDPR provisions for a particular research project to impact of the GDPR on long term collaborations, when the UK is leaving the EU are is discussed. This chapter sets out the aim of this book and provides an overview of how various contributions interplay to shed light on how the GDPR shapes the research regimes on the use of personal data in biobanking by EU Member States.
The Regulation of Biobanking in Germany
Authors: Hoppe Nils 
Published: January 2021

AbstractBiobanking in Germany is currently not subject to sui generis regulation. Instead, a plethora of norms from differing areas of law form the bundle of regulation that applies to biobanking. The exact shape and extent of the bundle depends on the exact configuration of the biobank. In the context of data protection, the rather fragmented nature of the regulation is to a certain extent alleviated by the direct impact of the EU General Data Protection Regulation (GDPR). In particular, the federalized system of data protection in Germany is simplified by an overarching set of norms that apply equally across the board. Whilst this is a welcome systematization of this part of the regulation of biobanking in Germany, the exact nature of the implementation of the Regulation raises novel issues in its own right. In this paper, I will outline the fragmented nature of biobank regulation in Germany, illustrate the issues on the basis of Germany’s population biobank NaKo and then discuss some of the more significant issues raised by the GDPR in the context of biobanking.
The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research
Authors: Penasa Simone , Tomasi Marta 
Published: January 2021

AbstractThe Italian context of biobanking is made up of a vast number of collections, in some cases well-organised and connected in virtuous networks and in others not identifiable as structured biobanks. From a comparative perspective, Italy can be regarded as a hybrid model, positioned between countries with full and detailed legislation concerning biobanks and those that rely only on guidelines published by national ethics committees or professional societies that have no binding legal value. In countries like Italy where the need for specific regulation is more urgent, the entry into force of the GDPR could have offered a chance to fill the gap in the legislation with regard to biobanking for medical scientific research purposes. This overview highlights the improvements made and the obstacles that persist.
Norwegian Biobanks: Increased Complexity with GDPR and National Law
Authors: Befring Anne Kjersti 
Published: January 2021

AbstractNorway is generally regarded as having good opportunities for biobank research because of Biobank Norway—its national infrastructure of biobanks—which represents one of the world’s largest existing resources within biobanking. It covers both consented population-based and disease-specific clinical biobanks. However, the regulatory framework in Norway for biobanking is fragmented, which makes navigating the legal landscape challenging.The Personal Data Act (PDA) implements the General Data Protection Regulation (GDPR), and a few adjustments were made in the national health legislation in order to bring it into line with the GDPR. The Health Research Act (HRA) enables the use of biobanking and personal data in research with and without the consent of individuals. There are some disagreements about the changes brought about by the GDPR when it comes to research on biological material that includes personal data. When implementing GDPR Article 89, it was emphasised that the Data Protection Officer (DPO) has an important role even though the research ethics committee has allowed the use of data (the regional committee for medical and health research ethics (REC)). This has created conflicts. This article highlights key issues and ambiguities related to the GDPR and national legislation, and the relationship between the two.
The New European Legal Framework on Personal Data Protection and the Legal Status of Biological Samples and Biobanks for Biomedical Research Purposes in Spanish Law
Authors: Romeo-Casabona Carlos M. 
Published: January 2021

AbstractBiomedical research has increasingly resorted to biological material, particularly in view of the enormous potential for the future of a better knowledge of the DNA of all living beings and even the possibility of modifying it by means of various techniques, including gene editing. For Precision Personalised Medicine the support of biobanks is also a very important tool.In relation to the protection of personal data, Spain has quickly implemented and adapted its internal laws to the GDPR through its new Organic Act 3/2018 of 5 of December on Protection of Personal Data and guarantee of digital rights. The new Act implements and completes some features of the GDPR, including those related to the provisions of Articles 9 and 89, in particular health related data and big data. In this way and by means of this ‘bridge’ Act, an attempt has also been made to guarantee the harmony between the GDPR and the pre-existing legislation, trying to ensure at the same time in effectiveness in promoting scientific research and in respecting for the rights of samples’ donors.
Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape
Authors: Tzortzatou Olga , Slokenberga Santa , Reichel Jane , da Costa Andrade Andreia , Barbosa Carla , Bekaert Sofie , van Veen Evert-Ben , Romeo-Casabona Carlos M. , Cathaoir Katharina Ó. , Chassang Gauthier , Debucquoy Annelies , Derèze Jean-Jacques , Dollé Laurent , Fält Sonja Eaker , Halouzka Radek , Hartlev Mette , Hisbergues Michael , Hoppe Nils , Huys Isabelle , Kindt Els , Befring Anne Kjersti , Kozera Lukasz , Krekora-Zajac Dorota , Lalova Teodora , Mayrhofer Michaela , Negrouk Anastassia , Pawlikowski Jakub , Penasa Simone , Pormeister Kärt , Rial-Sebbag Emmanuelle , Siapka Anastasia , Southerington Tom , Stenbeck Magnus , Šutalo Maja , Tomasi Marta , Valcke Peggy , Vella Falzon Ruth 
Published: January 2021

AbstractThis chapter seeks to provide insight into the ways in which Member States leveraged the regulatory discretion afforded to them by the GDPR. Specifically, it reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientific research and the role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and finally, the GDPR’s impact and future possibilities for biobanking. In exercising self-determination, Member States can, to a certain extent, align data protection requirements with their values and aspirations. Such alignment, though, could jeopardize collaborative research. In light of the need to bridge divergent legal and ethical requirements at a national and supranational level, the role of Research Ethics Committees (RECs) might prove to be essential.
Striking a Balance Between Personalised Genetics and Privacy Protection from the Perspective of GDPR
Authors: Hansson Mats G. 
Published: January 2021

AbstractGDPR is currently being implemented across Europe and researchers, ethical review boards and national authorities are waiting for guidance on how to do the ethical balancing of the interests of privacy and the interest of conducting effective scientific, e.g. biomedical research, in practice. In order to reach this one must both understand the specific challenges that are related to new developments within the field of personalised medicine where massive uses of personal data are foreseen and what it really means to protect someone’s privacy. In this chapter I will suggest how a balance may be reached between personalised medicine and privacy protection based on the premises of genetic science, ethics and the GDPR.
Biobank Oversight and Sanctions Under the General Data Protection Regulation
Authors: Hallinan Dara 
Published: January 2021

AbstractThis contribution offers an insight into the function and problems of the oversight and sanctions mechanisms outlined in the General Data Protection Regulation as they relate to the biobanking context. These mechanisms might be considered as meta-mechanisms—mechanisms relating to, but not consisting of, substantive legal principles—functioning in tandem to ensure biobank compliance with data protection principles. Each of the mechanisms outlines, on paper at least, comprehensive and impressive compliance architecture—both expanding on their capacity in relation to Directive 95/46. Accordingly, each mechanism looks likely to have a significant and lasting impact on biobanks and biobanking. Despite this comprehensiveness, however, the mechanisms are not immune from critique. Problems appear regarding the standard of protection provided for research subject rights, regarding the disproportionate impact on legitimate interests tied up with the biobanking process—particularly genomic research interests—and regarding their practical implementability in biobanking.
Resistance to (Digital) Change
Authors: Scholkmann Antonia B. 
Published: January 2021

AbstractResistance to change has been elaborated on from different perspectives: with a focus on employee resistance to change and as a systemic phenomenon, but also in the light of digital change and digital transformation. However, an integration of these approaches is not easy to find. This chapter discusses the phenomenon of resistance to change in light of current understandings of the concept as well as new elaborations, which might help to pinpoint specific challenges of digital change resistance. To this end, I will dive into the research traditions that have been built up around the concept. In order to understand resistance to digital change, specifically, I will draw upon the theory of Danish educational researcher Knut Illeris and explore the potential of his writings to explain resistance to digital change from a learning perspective. Throughout I will use examples from higher education digitalization research, to illustrate the respective phenomena. Key navigation points of this chapter are to elaborate resistance to (digital) change both as an individual and a systemic phenomenon and to contribute to a better understanding of resistance to digital change in light of incremental and disruptive change expectations.
Organizational Learning and Digital Transformation: A Theoretical Framework
Authors: Dörner Olaf , Rundel Stefan 
Published: January 2021

AbstractThe chapter discusses digital transformation as a potential source of crisis for the organization and develops a theoretical framework for further empirical research. The basic concept is that organizational learning is neither exclusively individually nor structurally and that actors and organizations are in a reciprocal relationship. Different requirements during digital transformation, either from the members of the organization or from the environment, force the organization to handle it. The chapter proposes four different ways, how organizations cope with digital transformation. Within the first two types, previous action routines terminate and organizational learning takes place. (1) The action routines of the members of the organization change, as well as there is a new understanding from the organization (educational process). (2) Digital transformation brings with it the implementation of the new digital objects, although the organizational members don’t act in a generally new way (learning process). Within the last two types, the organization refuses the requirements of the digital transformation. (3) The organization implements digital objects, but the organizational members don’t use them. And finally (4), the organization can actively refuse digital transformation.