bluuebunny/crossref_metadata_2025_split huggingface dataset:
Beschleunigte Zulassung von Arzneimitteln: Herausforderungen für Patient:innen, Datenqualität und faire Preise
Authors: Haas Antje , Mayer Thomas , Tebinka-Olbrich Anja , Blindzellner Maximilian , Beggerow Elisa , Nickel Andreas 
Published: October 2021

Zusammenfassung
Zusammenfassung
Beschleunigte Zulassungen stellen die Nutzenbewertung und Erstattung von Arzneimitteln vor besondere Herausforderungen. Der Artikel setzt sich in Form eines narrativen Reviews mit den Auswirkungen dieser Zulassungen auf Patient:innen, Angehörige der Gesundheitsberufe und die Solidargemeinschaft sowie mit den möglichen Lösungsstrategien auseinander. Die Autor:innen geben dazu anhand aktueller Literatur zunächst einen Überblick über die Zulassung von Arzneimitteln mit „conditional marketing authorisation“, „approval under exceptional circumstances“ sowie Orphan Drugs. Anschließend stellen sie den Einfluss beschleunigter Zulassungen auf die Nutzenbewertung dar und bewerten diesen. Zum Schluss beschreiben sie in diesem Zusammenhang Herausforderungen im Hinblick auf Arzneimittelpreise.
Initial experience with AcQMap catheter for treatment of persistent atrial fibrillation and atypical atrial flutter
Authors: Liebregts M. , Wijffels M. C. E. F. , Klaver M. N. , van Dijk V. F. , Balt J. C. , Boersma L. V. A. 
Published: October 2021

Abstract
Introduction
The AcQMap High Resolution Imaging and Mapping System was recently introduced. This system provides 3D maps of electrical activation across an ultrasound-acquired atrial surface.

Methods
We evaluated the feasibility and the acute and short-term efficacy and safety of this novel system for ablation of persistent atrial fibrillation (AF) and atypical atrial flutter.

Results
A total of 21 consecutive patients (age (mean ± standard deviation) 62 ± 8 years, 23% female) underwent catheter ablation with the use of the AcQMap System. Fourteen patients (67%) were treated for persistent AF and 7 patients (33%) for atypical atrial flutter. Eighteen patients (86%) had undergone at least one prior ablation procedure. Acute success, defined as sinus rhythm without the ability to provoke the clinical arrhythmia, was achieved in 17 patients (81%). At 12 months, 4 patients treated for persistent AF (29%) and 4 patients treated for atypical flutter (57%) remained in sinus rhythm. Complications included hemiparesis, for which intra-arterial thrombolysis was given with subsequent good clinical outcome (n = 1), and complete atrioventricular block, for which a permanent pacemaker was implanted (n = 2). No major complications attributable to the mapping system occurred.

Conclusion
The AcQMap System is able to provide fast, high-resolution activation maps of persistent AF and atypical atrial flutter. Despite a high acute success rate, the recurrence rate of persistent AF was relatively high. This may be due to the selection of the patients with therapy-resistant arrhythmias and limited experience in the optimal use of this mapping system that is still under development.
Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems using a pelvitrainer model: a randomized controlled study
Authors: Zwimpfer Tibor A. , Wismer Claudine , Fellmann-Fischer Bernhard , Geiger James , Schötzau Andreas , Heinzelmann-Schwarz Viola 
Published: October 2021

AbstractLaparoscopic surgery provides well-known benefits, but it has technological limitations. Depth perception is particularly crucial, with three-dimensional (3D) imaging being superior to two-dimensional (2D) HD imaging. However, with the introduction of 4K resolution monitors, 2D rendering is capable of providing higher-quality visuals. Therefore, this study aimed to compare 3D HD and 2D 4K imaging using a pelvitrainer model. Eight experts and 32 medical students were performing the same four standardized tasks using 2D 4K and 3D HD imaging systems. Task completion time and the number of errors made were recorded. The Wilcoxon test and mixed-effects models were used to analyze the results. Students were significantly faster in all four tasks when using the 3D HD perspective. The median difference ranged from 18 s in task 3 (P < 0.003) up to 177.5 s in task 4 (P < 0.001). With the exception of task 4, students demonstrated significantly fewer errors in all tasks involving 3D HD imaging. The experts’ results confirmed these findings, as they were also faster in all four tasks using 3D HD, which was significant for task 1 (P < 0.001) and task 4 (P < 0.006). The expert group also achieved better movement accuracy using the 3D HD system, with fewer mistakes made in all four tasks, which was significant in task 4 (P < 0.001). Participants in both groups achieved better results with the 3D HD imaging system than with the 2D 4K system. The 3D HD image system should be used when available. Trial registration: this trial is registered at research registry under the identifier researchregistry6852.
Observation and Maneuver Detection for Cislunar Vehicles
Authors: Greaves Jesse A. , Scheeres Daniel J. 
Published: October 2021

AbstractInternational interest in the sustained development of cislunar space will generate traffic and debris in the region which requires monitoring; similar to how current space situation awareness is necessary for the traffic and debris near Earth. There are many challenges associated with developing a cislunar situation awareness program, but 2 primary issues addressed by this paper are observational strategies and maneuver detection methods. This work proposes an observational strategy that utilizes the ballistic Optimal Control Based Estimator (OCBE) to filter measurements from cislunar optical observers. To reduce numerical issues associated with filtering, new modifications to the ballistic Optimal Control Based Estimator (OCBE) are introduced that preserve the OCBE update equations in Square Root Information (SRI) space. This new derivation produces a more stable version of the ballistic OCBE which is beneficial for filtering larger data sets with non-linear motion and measurements. Applying the SRI OCBE to the estimation problem it was found that only a single L2 observer with angle and angle-rate measurements provided sufficient information for consistent estimation. Then a newly developed maneuver detection method is presented to statistically identify maneuvers. The method applies a binary hypothesis test to the optimal control policy of the ballistic OCBE to quantify mismodeling. This method was tested given a impulsive maneuver policy with a mean of 50 mm/s and standard deviation of 15 mm/s, and 194 out of 200 tests correctly identified if a maneuver occurred. The OCBE control policy also provided appropriate impulse estimates of mismodeling, which may be used to reconstruct maneuvers in future work. Together, the proposed observation and maneuver detection methodology yields reliable tracking and provides a statistical framework to detect maneuvers.
Efficacy of the Orally Disintegrating Strip Sildenafil for the Treatment of Erectile Dysfunction: A Prospective, Randomized Trial
Authors: Sangkum Premsant , Sirisopana Kun , Matang Wijittra , Phengsalae Yada , Lertsithichai Panuwat , Ketsuwan Chinnakhet , Kochakarn Wachira , Kongchareonsombat Wisoot 
Published: October 2021

Abstract

Introduction
Phosphodiesterase 5 inhibitors are the predominant treatment option for erectile dysfunction.

Aim
This study evaluates the efficacy and safety of sildenafil orally disintegrating strips for the treatment of erectile dysfunction.

Methods
One hundred twenty erectile dysfunction patients were enrolled in a prospective, randomized, controlled crossover study and allocated into 2 groups of 60 participants. Patients were either treated with sildenafil strips or tablets for 8 weeks after which they crossed over into the alternate treatment formulation for another 8 weeks following a 4-week wash-out period. Each participant was assessed 8 times throughout the study period and their formulation preference registered at the end of the study.

Main outcomes and measures
Changes in the abridged International Index of Erectile Function (IIEF-5) score and Erection Hardness Score (EHS) resulting from sildenafil orally disintegrating strip or tablet treatments were the primary end points, with differences in onset of action, duration of action, and incidence of adverse events between the 2 formulations included as secondary end points.

Results
Both sildenafil formulations were effective in treating patients with erectile dysfunction. There was significant improvement of erectile function in term of IIEF-5 score and EHS from both formulations. The number and type of adverse events were also comparable. Likewise, there were no statistically significant differences between the earliest onset of action times and longest duration of action times. However, the results showed a 7.1-minute earlier onset of action time for orally disintegrating strips that may be considered as clinically meaningful by some patients.

Conclusion
Sildenafil orally disintegrating strips are a safe and effective alternative to the conventional tablet formulation for the treatment of erectile dysfunction.
Pas encore classiques: La fabrique des antiquités américaines au xixe siècle
Authors: Achim Miruna , Gänger Stefanie 
Published: October 2021

Pas encore classiques: La fabrique des antiquités américaines au xixe siècleLes antiquités précolombiennes sont devenues une catégorie esthétique, scientifique, commerciale et juridique reconnaissable au cours du xixe siècle. Cet article présente les acteurs, les sites et les configurations matérielles et idéologiques qui jouèrent un rôle dans sa construction et son développement. La première section examine la tradition antiquaire ibérique qui, vers le milieu du xviie siècle, a mis en circulation les artefacts d’avant la conquête en tant qu’objets épistémiques, dans le contexte de la pertinence croissante des vestiges matériels comme objets d’investigation. L’article se penche ensuite sur les scènes de collecte dans les pays d’Amérique hispanique nouvellement indépendants, où les élites créoles, les musées locaux et les étrangers, mus par leurs propres intérêts, se sont disputé les antiquités. La troisième section explore la manière dont, au milieu du xixe siècle, les « technologies du papier » ont fonctionné comme des outils heuristiques pour connaître, organiser et interpréter les antiquités, conférant une densité ontologique à des objets et groupes d’objets spécifiques et conduisant à la construction de régimes de savoirs et d’expertises dédiés. Enfin, la quatrième section reconstruit les processus nationaux et internationaux d’institutionnalisation du passé d’avant la conquête à la fin des années 1800 et au début des années 1900 – à travers la consolidation des musées nationaux et la constitution de l’archéologie et de l’ethnographie comme disciplines scientifiques – afin d’examiner comment ceux-ci ont renforcé l’importance et la signification des antiquités.
Parliamentary Representation in Modern Britain: Past, Present, and Future
Authors: Taylor Miles 
Published: October 2021

AbstractA series of recent books all attest to a revival of interest in the theory and practice of parliamentary representation in the modern era as a scholarly discipline. This review surveys eight different aspects of that history since the early nineteenth century: the spatial dimension of the Palace of Westminster; the comparative framework offered by the history of parliaments in Europe; ideas of parliamentary representation; the history of parliamentary procedure; women in parliament; the House of Lords; the history of corruption; and the Brexit crisis. Insights and perspectives are drawn from recent historical research as well as from political science and intellectual history. The review concludes by observing that the history of parliamentary representation in the modern era is in good shape. Some older interpretive paradigms still lurk, especially an obsession with ‘democratization’. However, more is now known about individual MPs and constituencies than ever before. The digitization of the records of parliament is expediting the kind of longitudinal analysis which was impossible back in the 1960s and 1970s. And the intellectual history and public policy literature around the idea of representation is enjoying a renaissance.
Vaccination rates in cochlear implant patients: a review of paediatric recipients
Authors: Rose O , Moriarty R , Brown C , Teagle H , Neeff M 
Published: October 2021

AbstractObjectiveThis study aimed to investigate whether children with cochlear implants received the recommended vaccinations according to New Zealand national immunisation guidelines and to report the incidence of meningitis in this population after intervention.MethodA retrospective review of the vaccination coverage of paediatric patients receiving cochlear implants between 2005 and 2019 was performed.ResultsData were collected on 203 children. Evidence of immunisation against Haemophilus influenza B was documented in 94.1 per cent of this cohort and 21.2 per cent received the seasonal influenza vaccine. The pneumococcal conjugate vaccine was fully administered in 81.8 per cent of children; however, only 16.9 per cent of eligible children had received the pneumococcal polysaccharide vaccine. There was marked improvement in compliance to the pneumococcal conjugate vaccine once it became fully funded for cochlear implant patients.ConclusionDespite established guidelines, the paediatric vaccination rates were less than expected. Work is in progress to address this.
Adaptation, adjudication, and private ordering: Contractual Relations through the Williamson Lens
Authors: Masten Scott E. 
Published: October 2021

AbstractWilliamson's legacy will be permanently, and deservedly, linked with the theory of the firm. As important, however, is his contribution to our understanding of contracting. My aim here is to describe Williamson's conception of contracting, how it differs from other approaches to contracting, and some implications of that approach for contract design and enforcement. I argue that Williamson's ‘process orientation’ – in which the main dimension along which contracts vary is the extent to which contract adjustments are effected through court ordering versus private ordering – provides alternative interpretations of some conventional contract terms but also sheds light on some otherwise puzzling contractual phenomena.
Simulation of Crop Water Demand and Consumption Considering Irrigation Effects Based on Coupled Hydrology‐Crop Growth Model
Authors: Zhang Yuliang , Wu Zhiyong , Singh Vijay P. , Su Qiong , He Hai , Yin Hao , Zhang Yaxin , Wang Fang 
Published: October 2021

AbstractHydrological models are widely used in regional drought assessments. Usually, the spatiotemporal development of droughts is evaluated only via drought indexes based on simulated soil moisture. However, the physiological status of crops is key to accurately assessing the effect of drought, and hydrological models either do not consider crop physiological status or oversimplify it. In addition, the effects of reservoirs, irrigation, and crop rotation are generally not considered. To overcome the oversimplification of crop and irrigation modules in hydrological models, the variable infiltration capacity (VIC) model was coupled with the Environmental Policy Integrated Climate model. Irrigation and reservoir modules were introduced into the coupled hydrology‐crop growth (CHC) model. The CHC model was built for the watershed upstream of Heilin hydrological station on the Qingkou River on the border of Jiangsu and Shandong Provinces, China. The model performance was compared with simulation results of the Soil and Water Assessment Tool and VIC, which showed that the CHC model was more accurate. The temporal variation of water consumption and demand of three crop rotations, namely spring peanuts, summer peanuts‐winter wheat, and summer corn‐winter wheat, in the study area was analyzed. Drought area data obtained from Junan County yearbooks were consistent with the simulated water deficit and drought index considering the effect of irrigation. Crop irrigation increased soil water content and evapotranspiration and decreased crop water deficit. Therefore, crop irrigation was considered in hydrological simulations. The CHC model reliably simulated crop water consumption, soil moisture, and drought index, and the model simulated data could be used as basic data for water resources management and drought mitigation measures.
Selective and competitive functions of the AAR and UPR pathways in stress-induced angiogenesis
Authors: Zhang Fan , Zeng Qi-Yu , Xu Hao , Xu Ai-Ning , Liu Dian-Jia , Li Ning-Zhe , Chen Yi , Jin Yi , Xu Chun-Hui , Feng Chang-Zhou , Zhang Yuan-Liang , Liu Dan , Liu Na , Xie Yin-Yin , Yu Shan-He , Yuan Hao , Xue Kai , Shi Jing-Yi , Liu Ting Xi , Xu Peng-Fei , Zhao Wei-Li , Zhou Yi , Wang Lan , Huang Qiu-Hua , Chen Zhu , Chen Sai-Juan , Zhou Xiao-Long , Sun Xiao-Jian 
Published: October 2021

AbstractThe amino acid response (AAR) and unfolded protein response (UPR) pathways converge on eIF2α phosphorylation, which is catalyzed by Gcn2 and Perk, respectively, under different stresses. This close interconnection makes it difficult to specify different functions of AAR and UPR. Here, we generated a zebrafish model in which loss of threonyl-tRNA synthetase (Tars) induces angiogenesis dependent on Tars aminoacylation activity. Comparative transcriptome analysis of thetars-mutant and wild-type embryos with/without Gcn2- or Perk-inhibition reveals that only Gcn2-mediated AAR is activated in thetars-mutants, whereas Perk functions predominantly in normal development. Mechanistic analysis shows that, while a considerable amount of eIF2α is normally phosphorylated by Perk, the loss of Tars causes an accumulation of uncharged tRNAThr, which in turn activates Gcn2, leading to phosphorylation of an extra amount of eIF2α. The partial switchover of kinases for eIF2α largely overwhelms the functions of Perk in normal development. Interestingly, although inhibition of Gcn2 and Perk in this stress condition both can reduce the eIF2α phosphorylation levels, their functional consequences in the regulation of target genes and in the rescue of the angiogenic phenotypes are dramatically different. Indeed, genetic and pharmacological manipulations of these pathways validate that the Gcn2-mediated AAR, but not the Perk-mediated UPR, is required fortars-deficiency induced angiogenesis. Thus, the interconnected AAR and UPR pathways differentially regulate angiogenesis through selective functions and mutual competitions, reflecting the specificity and efficiency of multiple stress response pathways that evolve integrally to enable an organism to sense/respond precisely to various types of stresses.
Kinetic and structural roles for the surface in guiding SAS-6 self-assembly to direct centriole architecture
Authors: Banterle Niccolò , Nievergelt Adrian P. , de Buhr Svenja , Hatzopoulos Georgios N. , Brillard Charlène , Andany Santiago , Hübscher Tania , Sorgenfrei Frieda A. , Schwarz Ulrich S. , Gräter Frauke , Fantner Georg E. , Gönczy Pierre 
Published: October 2021

AbstractDiscovering mechanisms governing organelle assembly is a fundamental pursuit in biology. The centriole is an evolutionarily conserved organelle with a signature 9-fold symmetrical chiral arrangement of microtubules imparted onto the cilium it templates. The first structure in nascent centrioles is a cartwheel, which comprises stacked 9-fold symmetrical SAS-6 ring polymers emerging orthogonal to a surface surrounding each resident centriole. The mechanisms through which SAS-6 polymerization ensures centriole organelle architecture remain elusive. We deploy photothermally-actuated off-resonance tapping high-speed atomic force microscopy to decipher surface SAS-6 self-assembly mechanisms. We show that the surface shifts the reaction equilibrium by ~104 compared to solution. Moreover, coarse-grained molecular dynamics and atomic force microscopy reveal that the surface converts the inherent helical propensity of SAS-6 polymers into 9-fold rings with residual asymmetry, which may guide ring stacking and impart chiral features to centrioles and cilia. Overall, our work reveals fundamental design principles governing centriole assembly.
Selection on adaptive and maladaptive gene expression plasticity during thermal adaptation to urban heat islands
Authors: Campbell-Staton Shane C. , Velotta Jonathan P. , Winchell Kristin M. 
Published: October 2021

AbstractPhenotypic plasticity enables a single genotype to produce multiple phenotypes in response to environmental variation. Plasticity may play a critical role in the colonization of novel environments, but its role in adaptive evolution is controversial. Here we suggest that rapid parallel regulatory adaptation ofAnolislizards to urban heat islands is due primarily to selection for reduced and/or reversed heat-induced plasticity that is maladaptive in urban thermal conditions. We identify evidence for polygenic selection across genes of the skeletal muscle transcriptome associated with heat tolerance. Forest lizards raised in common garden conditions exhibit heat-induced changes in expression of these genes that largely correlate with decreased heat tolerance, consistent with maladaptive regulatory response to high-temperature environments. In contrast, urban lizards display reduced gene expression plasticity after heat challenge in common garden and a significant increase in gene expression change that is congruent with greater heat tolerance, a putatively adaptive state in warmer urban environments. Genes displaying maladaptive heat-induced plasticity repeatedly show greater genetic divergence between urban and forest habitats than those displaying adaptive plasticity. These results highlight the role of selection against maladaptive regulatory plasticity during rapid adaptive modification of complex systems in the wild.
A reasonable approach for the generation of hollow icosahedral kernels in metal nanoclusters
Authors: Kang Xi , Wei Xiao , Liu Xiaokang , Wang Sicong , Yao Tao , Wang Shuxin , Zhu Manzhou 
Published: October 2021

AbstractAlthough the hollow icosahedral M12 kernel has been extensively observed in metal nanoclusters, its origin remains a mystery. Here we report a reasonable avenue for the generation of the hollow icosahedron: the kernel collapse from several small nano-building blocks to an integrated hollow icosahedron. On the basis of the Au alloying processes from Ag28Cu12(SR)24 to the template-maintained AuxAg28-xCu12(SR)24 and then to the template-transformed Au12CuyAg32-y(SR)30, the kernel evolution/collapse from “tetrahedral Ag4 + 4∗Ag3” to “tetrahedral Au4 + 4∗M3 (M = Au/Ag)” and then to “hollow icosahedral Au12” is mapped out. Significantly, the “kernel collapse” from small-sized nano-building blocks to large-sized nanostructures not only unveils the formation of hollow icosahedral M12 in this work, but also might be a very common approach in constructing metallic kernels of nanoclusters and nanoparticles (not limited to the M12 structure).