bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analyse erneuter AMNOG-Nutzenbewertungen von Arzneimitteln im gleichen Anwendungsgebiet
Authors: Rieder Veronika , Hammerschmidt Thomas 
Published: April 2018

Zusammenfassung
Zielsetzung Seit 2011 werden in Deutschland neuartige Arzneimittel zum Zeitpunkt der Markteinführung einer frühen Nutzenbewertung (FNB) mit anschließender Preisverhandlung unterzogen (AMNOG). Zu diesem Zeitpunkt ist die Evidenz zum Nutzen des Arzneimittels limitiert. Eine erneute Nutzenbewertung (ENB) im gleichen Anwendungsgebiet auf Basis neuerer Evidenz ist allerdings nicht regelhaft, sondern nur in Einzelfällen vorgesehen. Ziel ist, die Ergebnisse von ENB im gleichen Anwendungsgebiet zu untersuchen.
Methodik Analyse sämtlicher Verfahren mit abgeschlossener ENB in den Jahren 2011–2016.
Ergebnisse Unter den 228 Nutzenbewertungsverfahren sind 52 zu 26 Arzneimitteln mit FNB und ENB im gleichen Anwendungsgebiet. Überproportional viele ENB wurden bei Onkologika und Antidiabetika durchgeführt. Bei 15 Arzneimitteln mit nachgewiesenem Zusatznutzen hatte der G-BA den FNB-Beschluss befristet wegen unzureichender Datenlage zur Markteinführung, teils begründet durch bedingte Zulassungen. Die ENB fand nach 2,6 Jahren statt. Sie führte in 4 Fällen zu einer höheren und in 5 Fällen zu einer niedrigeren Nutzenbewertung. Für 7 Arzneimittel ohne Zusatznutzen beantragten die Hersteller eine ENB auf Basis neuer Evidenz nach ca. 1,7 Jahren. Drei dieser Arzneimittel konnten in der ENB einen Zusatznutzen nachweisen. 4 Orphan Drugs wurden gemäß gesetzlicher Vorgabe erneut bewertet, nachdem sie die Jahresumsatzschwelle von 50 Mio. € überschritten. Bei einem Orphan Drug kam es zu einer besseren, bei 2 zu einer schlechteren Nutzenbewertung. Die durchschnittliche Verbesserung beträgt 1,5 Punkte auf einer Bewertungsskala von −3 (Beleg für geringeren Zusatznutzen) bis 9 (Beleg für erheblichen Zusatznutzen) und ist begründet durch neue Datenschnitte und Studien. Die Verschlechterung beträgt durchschnittlich −1,4 Punkte. Es zeigt sich eine signifikante Korrelation der Veränderung der Nutzenbewertung mit der Veränderung des verhandelten Preises.
Schlussfolgerungen Die ENB auf Basis einer breiteren Evidenzgrundlage führt nicht zu einer wesentlichen Änderung der Nutzenbewertung und kann die Aussagesicherheit auch nur geringfügig erhöhen. Eine generelle ENB erscheint daher vor dem Hintergrund des administrativen Aufwands nicht gerechtfertigt. Das selektive Verfahren, erneute Nutzenbewertungen durchzuführen, ist hinreichend für Adjustierungen der Nutzenbewertung, wenn die Datenlage zur Markteinführung unzureichend erscheint.
Diskussionsprozesse im Rahmen der Priorisierung von Arzneimitteln
Authors: Potempa Christoph 
Published: April 2018

Aumann I et al. Priorisierung und Rationierung von Arzneimittel – eine experimentelle Analyse von Diskussionsprozessen. Z Evid Fortbild Qual Gesundh wesen 2017;
125: 3–13
Am Beispiel von vier fiktiven Arzneimitteln zur Behandlung unterschiedlicher Lungenerkrankungen haben die Autoren um Aumann et al. auf Basis von sechs
leitfadengestützten Gruppendiskussionen versucht, einen exemplarischen Diskussionsprozess zur Priorisierung von Arzneimitteln nachzuzeichnen – und liefern
damit Denkanstöße für künftige Entscheidungsszenarien.
Benefit of Cochlear Implantation in Children with Multiple-handicaps: Parent's Perspective
Authors: Nasralla Heloisa , Montefusco Adilson , Hoshino Ana , Samuel Paola , Magalhães Ana , Goffi-Gomez Maria , Tsuji Robinson , Bento Ricardo 
Published: April 2018

Introduction The cochlear implants centers in the world are studying the cochlear implantation in children with multiple handicaps.
Objective To develop a questionnaire to analyze the subjective benefits of the cochlear implantation in multiple handicapped children according to their parent's perspective.
Methods A questionnaire was applied to 14 families of multiple handicapped children, aging from 2–12 years old and having from 11 months to 11 years of implant use.
Results The social-emotional abilities were improved because of many factors, such as: auditory exposure, which happened in 84% of the children; recognition of their own names, which increased in 56%; and development of eye contact, in 28% of the subjects. Other benefits appeared to be: music appreciation and more attention and adherence to other therapies and school activities. Besides, some children became interested in objects, playing with other children, and more adapted to daily routines. Thirty-five percent of the children acquired oral language, mainly the bilaterally implanted, while 14% of them were engaged in sign language. Although all of the children showed a significant improvement in communication, the emotional issues of some families and the severity of the handicaps negatively impacted the outcomes. In spite of the families' acknowledgement of some benefits, the diagnosis of autism spectrum disorder caused frustration, requiring a readjustment of the expectations.
Conclusion The questionnaire turned out to be an adequate tool to reveal the social-emotional benefits of cochlear implantation. Although oral language was not the major outcome in these cases, the cochlear implant benefits involved the whole family. All of the families recommended the implant to other children in a similar situation.
Evolution of Keratoconus: From Diagnosis to Therapeutics
Authors: Imbornoni Lauren , McGhee Charles , Belin Michael 
Published: April 2018

AbstractThis review describes the evolution of the diagnosis and treatment of keratoconus from the earliest written description to present day. The first description was provided in 1736 by Benedict Duddell who described the prominent corneas of a fourteen-year-old boy. Throughout the 19th century, a variety of surgical procedures were proposed to manage the disease, such as surgically repositioning the pupil away from the cone, iris incarceration to produce a slit-like pupil, cauterization of the cone to produce a scar, and full thickness elliptical excision of the cone. Despite the ingenuity of these procedures, many led to serious complications. In 1936, Ramon Castroviejo revolutionized surgical management by performing the first corneal transplant for keratoconus. The advent of refractive surgery in the 1990s brought about a sudden and critical need for better understanding of keratoconus and corneal ectatic disease. Topographic analysis allowed for earlier detection of keratoconus, prior to clinical signs and symptoms. Tomographic analysis provided analysis of the anterior and posterior surfaces of the cornea and allowed for even earlier detection. The Belin/Ambrosio Enhanced Ectasia Display on the Pentacam incorporates anterior and posterior elevation, pachymetric map, best fit sphere and enhanced reference surface to provide an overall “D” value that is predictive of ectatic disease. This display allows refractive providers to quickly and accurately screen potential refractive surgery candidates to identify those at risk for ectasia and early subclinical keratoconus. Corneal crosslinking was revolutionary in the treatment of keratoconus. There have been several randomized controlled trials that have found it to be safe and effective to halt ectatic progression. Crosslinking was recently approved by the FDA for progressive keratoconus. Currently, there is no clear definition of ectasia progression. Providers must be able to clearly, objectively and consistently diagnose progressive disease to institute timely treatment in the population with the greatest potential benefit. The new Belin ABCD grading system and progression analysis incorporated into the Oculus Pentacam software provides an objective way of assessing progression over time. Keratoconus diagnosis and management have grown tremendously since the first description in 1736, but there is still much to learn about keratoconus and its management.
How sign language interpreters use multimodal actions to coordinate turn-taking in group work between deaf and hearing upper secondary school students
Authors: Berge Sigrid Slettebakk 
Published: April 2018

Abstract
This study examines interpreted group work situations involving deaf and hearing senior high school students, using Norwegian Sign Language and spoken Norwegian. The research question is: how does the sign language interpreter explicitly coordinate turn-taking in group work dialogues among deaf and hearing students? Video recordings of authentic learning situations constitute the basis for analysis of how a sign language interpreter uses multimodal actions to convey information that is used by the deaf and hearing students in establishing a shared focus of attention and thus coordinating their turn-taking. Five types of actions were recurrently identified: construction of visual gestures; timing of the interpreter’s input; use of gaze to negotiate for the deaf students’ speaking turns; left-right shifts in body position to convey information about which of the hearing students is speaking; and backward-forward shifts in body position to negotiate for shared attention. The analysis draws mainly on concepts developed by Goffman (1959, 1981), Goodwin (1994, 2000, 2007) and Wadensjö (1998). The discussion examines implications for the educational interpreter’s role set (Sarangi 2010, 2011), and the dual responsibility s/he fulfils by not only interpreting the students’ utterances, but also explicitly coordinating their interaction.
Foreign language teaching – Integrationism vs. MGM
Authors: Grein Marion 
Published: April 2018

Abstract
Modern language teaching is no longer grammar based, but based on authentic real life dialogues (dialogic speech acts) which enable learners to communicate or rather to interact verbally and nonverbally competent with native speakers. The conception of language teaching curricula, especially with regard to the development of textbooks, is in need of an applicable model of communication, based on regularities or principles of language-usage. Both, Integrationism and the Mixed Game Model (MGM) opt against segregational static approaches of linguistic analysis and – at first glance – could be considered suitable approaches within the field of language teaching. Yet, I will argue that the Integrational approach is hardly applicable here, whereas the MGM perfectly suits the needs of foreign language textbook authors and editors.
The persuasive use of pronouns in action games of election campaigns
Authors: Săftoiu Răzvan , Toader Adrian 
Published: April 2018

Abstract
Action games of election campaigns are one of the best venues for politicians to team up with specialists in communication studies in order to build, review, construct or deconstruct their own or their opponent’s image with the purpose of persuading the electorate to vote for a certain political group. Various action games of Donald Trump’s presidential campaign are analysed with regard to different dialogic means used by the speaker in order to persuade the audience to vote for him. For instance, he evokes nationalistic views in his speeches and skilfully uses pronouns in order to establish his role as dominant, strong, and credible nominee for presidency. Since we focus on a particular practice in dialogic language use, we will show that the Mixed Game Model (MGM) is more appropriate to study the argumentative power of words than integrationism.
Abandoning the simple by disintegrating the sign?
Authors: Pablé Adrian 
Published: April 2018

Abstract
In this comparative paper I suggest that linguistic theories need to be discussed in terms of the metatheoretical presuppositions sustaining them. In view of Edda Weigand’s rejection of the linguistic sign and her critique of Roy Harris’ integrational linguistics for failing to abandon the sign as its working concept and not adopting a holistic model that accounts for the complexity of human communication, I will argue that the key to understanding linguistic theories is semiology, including tacitly assumed – since ‘commonsensical’ – beliefs about what constitutes ‘language’, ‘a language’ and ‘communication’ (i.e. the metatheory). I will further argue that methodological considerations are not the primary domain of semiology. This paper is designed (i) as an integrational critique of Weigand’s conception of human communication as intentional and intersubjective and (ii) as an affirmation that linguistic indeterminacy concerns both form and meaning.
Integrationist reflections on the place of dialogue in our communicational universe
Authors: Jones Peter E. 
Published: April 2018

AbstractRoy Harris identifies the “main flaw” in J. L. Austin’s account of language as a “failure to consider to what extent being able to ‘do things with words’ is parasitic on being able to do things without them”. Harris’s comment here serves as a springboard for a critical evaluation of communicational theories based around “talk-in-interaction” or dialogic principles. The primacy thereby given to linguistic interaction arguably entails a mystification of communication processes and the dis-integration of the social world into which our communicational experiences are intervowen. Consequently, the ghost of segregationism, in the shape of Harris’s “fallacy of verbalism”, continues to haunt, at times faintly, at times aggressively, the assumptions and methodologies of the approaches in question.
Integrating self, voice, experience
Authors: Thibault Paul J. 
Published: April 2018

AbstractThe experience of hearing one’s own voice during the act of speaking is a form of self-awareness and self-reflection that occurs in relation to and in interaction with the flow of experience, including the experience of other selves and their voices. Self-communication is deeply implicated in and necessary for interpersonal communication (Harris 1996). And yet, it is the latter which is generally taken to be the paradigm case of human languaging. The fundamental role of self-communication is neglected in the language sciences. Starting with the important fact that we hear our own voice when we speak (Harris 1996, chap. 11), this paper examines the central role of self-communication in the emergence of the self and the self’s role in languaging.
In lacu leonum: fosse, tanière, parc ou ménagerie?
Authors: Vassilieva-Codognet Olga 
Published: April 2018

Si l’iconographie de Daniel dans la fosse aux lions a suscité de nombreux travaux qui se sont intéressés aux représentations de ce thème dans l’Antiquité et le haut Moyen Âge, aucun d’entre eux n’a abordé le traitement de l’épisode vétérotestamentaire dans l’enluminure médiévale. Cette étude n’est pourtant pas sans intérêt puisque la tradition médiévale du manuscrit enluminé, et plus spécialement celle de la Bible enluminée – le motif de Daniel et des lions constitue le choix préféré des miniaturistes pour illustrer le Livre de Daniel –, a permis de conserver pendant plusieurs siècles l’un des premiers motifs de l’art chrétien tout en le modifiant progressivement par l’ajout de détails réalistes. En particulier, les différentes interprétations de ce que pouvait être une ʻfosse aux lionsʼ ont donné naissance, tout au long du Moyen Âge, à des représentations plastiques qui vont du trou noir abstrait jusqu’à la ménagerie réaliste en passant par la tanière, le puits, ou encore le parc de chasse.
Le Vultur dans le De animalibus d’Albert le Grand
Authors: Wille Clara 
Published: April 2018

Albert le Grand, dans son œuvre intitulée De animalibus, a rédigé un vaste commentaire de l’œuvre zoologique d’Aristote se basant sur la traduction arabo-latine du De animalibus de Michel Scot – une traduction latine d’une traduction arabe des trois grands traités sur les animaux d’Aristote en dix-neuf livres. Mais Albert a ajouté à l’Aristote arabo-latin sept livres supplémentaires sur les animaux selon le modèle encyclopédique du Liber de natura rerum de Thomas de Cantimpré. Le traité zoologique De animalibus d’Albert le Grand est donc beaucoup plus volumineux que l’œuvre aristotélicienne qu’il commente et consiste en vingt-six livres. Le présent article propose de comparer les notices consacrées au vultur, vautour, dans les deux parties du De animalibus d’Albert le Grand. L’étude de ces différentes mentions peut ainsi nous informer sur le rapport entre les deux parties ainsi que sur la méthode de travailler et l’objectif scientifique d’Albert le Grand.
Where Translation Studies lost the plot
Authors: Pym Anthony 
Published: April 2018

AbstractRecent interest in the role of translation in language teaching calls for dialogue between the disciplines of Translation Studies and Language Education. In framing this dialogue, translation scholars would do well to avoid assuming superiority or special knowledge; they would instead do well to reflect on the history of their own discipline, particularly the opposition to language departments that can be found in some countries in the 1980s and 1990s. In politically turning away from language learning, translation scholars left the education field open for unopposed implantation of immersion and communicative teaching methods that ideologically shunned translation. Further, in framing their major internal debates in terms of binary categories, usually involving a good translation method opposed to a bad one, translation scholars themselves all but abandoned the non-binary pedagogical models that once included many types of translation solutions. Those non-binary models should now be investigated anew in order to rebrand translation for the language-education community. In so doing, however, translation scholars may need to break the unspoken pact that they have developed with the translation professions. They should instead adopt a view where everyone can translate, not just professionals, and everyone can be trained to translate better.
A model solution for English-Arabic-English translation students
Authors: Bazzi Samia 
Published: April 2018

AbstractThis paper proposes a model that addresses students’ common errors in English-Arabic-English translation. My study documents an attempt to develop a new interconnectedness between students’ errors and translation theories that may improve their performance when translating different genres. Consistent and repeated errors produced by tens of students working on the same texts were compiled and analyzed. The errors showed lack of knowledge of genre structure, functional analysis, appropriate intervention as well as lack of understanding of the wider context upon which appropriate decisions can be made. The methodology expounded in this study involves describing and categorizing students’ errors. It suggests solutions grounded in translation theory and proposes comparisons with professional translations. This methodology proved to be very successful during my teaching experience at the Lebanese University.1The model solution developed in this study draws on genre analysis, text-typology, text-functionality, register analysis, and equivalence. The application of the model solution minimized students’ errors to a large extent and enabled them to provide accurate descriptions of different translation strategies and critically assess professional translations.
Microstructure characterisation of Fe–21Cr–15Ni–Nb–V non-magnetic austenitic stainless steel during hot deformation
Authors: Song Yan-Lei , Li Chang-Sheng , Li Bin-Zhou , Han Ya-Hui 
Published: April 2018

Hot deformation behaviour of Fe–21Cr–15Ni–Nb–V stainless steel was investigated by isothermal compression in the temperature range of 950–1150°C with a strain rate of 0.01–10 s−1. The results showed that complete recrystallisation occurred beyond 1050°C, resulting from the pinning effect of (Nb, V)(C, N). The nucleation of dynamic recrystallisation (DRX) was performed by the bulging, sub-grain swallowing and twinning mechanism. With increasing strain rate, new twinning was transformed into the Σ3 regeneration mechanism in the partial DRX region, while an opposite transformation was observed in the complete DRX region. In the partial recrystallisation region, grain rotation resulted in the formation of 110 orientation. In the complete recrystallisation region, the texture tended to distribute randomly at a high strain rate, and the grain growth was accompanied by the emergence of stable 100 orientation. GRAPHICAL ABSTRACT
Extracellular vesicles from bone marrow‐derived mesenchymal stromal cells support ex vivo survival of human antibody secreting cells
Authors: Nguyen Doan C. , Lewis Holly C. , Joyner Chester , Warren Vivien , Xiao Haopeng , Kissick Haydn T. , Wu Ronghu , Galipeau Jacques , Lee F. Eun‐Hyung 
Published: April 2018

ABSTRACTExtracellular vesicles (EVs) from bone marrow (BM)‐derived mesenchymal stromal cells (BM‐MSC) are novel mechanisms of cell‐cell communication over short and long distances. BM‐MSC have been shown to support human antibody secreting cells (ASC) survival ex vivo, but whether the crosstalk between the MSC‐ASC interaction can occur via EVs is not known. Thus, we evaluated the role of EVs in ASC survival and IgG secretion. EVs were isolated from irradiated and non‐irradiated primary BM‐MSC and were quantified. They were further characterized by electron microscopy (EM) and CD63 and CD81 immuno‐gold EM staining. Human ASC were isolated via fluorescence‐activated cell sorting (FACS) and cultured ex vivo with the EV fractions, the EV‐reduced fractions, or conventional media. IgG Elispots were used to measure the survival and functionality of the ASC. Contents of the EV fractions were evaluated by proteomics. We saw that both irradiated and non‐irradiated MSC secretome preparations afforded vesicles of a size consistent with EVs. Both preparations appeared comparable in EM morphology and CD63 and CD81 immuno‐gold EM. Both irradiated and non‐irradiated EV fractions supported ASC function, at 88% and 90%, respectively, by day 3. In contrast, conventional media maintained only 4% ASC survival by day 3. To identify the specific factors that provided in vitro ASC support, we compared proteomes of the irradiated and non‐irradiated EV fractions with conventional media. Pathway analysis of these proteins identified factors involved in the vesicle‐mediated delivery of integrin signalling proteins. These findings indicate that BM‐MSC EVs provide an effective support system for ASC survival and IgG secretion.
ImagePy: an open-source, Python-based and platform-independent software package for bioimage analysis
Authors: Wang Anliang , Yan Xiaolong , Wei Zhijun 
Published: April 2018

AbstractSummaryThis note presents the design of a scalable software package named ImagePy for analysing biological images. Our contribution is concentrated on facilitating extensibility and interoperability of the software through decoupling the data model from the user interface. Especially with assistance from the Python ecosystem, this software framework makes modern computer algorithms easier to be applied in bioimage analysis.Availability and implementationImagePy is free and open source software, with documentation and code available at https://github.com/Image-Py/imagepy under the BSD license. It has been tested on the Windows, Mac and Linux operating systems.
Nef Cones of Nested Hilbert Schemes of Points on Surfaces
Authors: Ryan Tim , Yang Ruijie 
Published: April 2018

AbstractLet X be the projective plane, a Hirzebruch surface, or a general K3 surface. In this paper, we study the birational geometry of various nested Hilbert schemes of points parameterizing pairs of zero-dimensional subschemes on X. We calculate the nef cone for two types of nested Hilbert schemes. As an application, we recover a theorem of Butler on syzygies on Hirzebruch surfaces.