bluuebunny/crossref_metadata_2025_split huggingface dataset:
Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis
Authors: Dane Aaron , Spencer Amy , Rosenkranz Gerd , Lipkovich Ilya , Parke Tom ,   on behalf of the PSI/EFSPI Working Group on Subgroup Analysis
Published: December 2018

Subgroup by treatment interaction assessments are routinely performed when analysing clinical trials and are particularly important for phase 3 trials where the results may affect regulatory labelling. Interpretation of such interactions is particularly difficult, as on one hand the subgroup finding can be due to chance, but equally such analyses are known to have a low chance of detecting differential treatment effects across subgroup levels, so may overlook important differences in therapeutic efficacy. EMA have therefore issued draft guidance on the use of subgroup analyses in this setting. Although this guidance provided clear proposals on the importance of pre‐specification of likely subgroup effects and how to use this when interpreting trial results, it is less clear which analysis methods would be reasonable, and how to interpret apparent subgroup effects in terms of whether further evaluation or action is necessary.A PSI/EFSPI Working Group has therefore been investigating a focused set of analysis approaches to assess treatment effect heterogeneity across subgroups in confirmatory clinical trials that take account of the number of subgroups explored and also investigating the ability of each method to detect such subgroup heterogeneity. This evaluation has shown that the plotting of standardised effects, bias‐adjusted bootstrapping method and SIDES method all perform more favourably than traditional approaches such as investigating all subgroup‐by‐treatment interactions individually or applying a global test of interaction. Therefore, these approaches should be considered to aid interpretation and provide context for observed results from subgroup analyses conducted for phase 3 clinical trials.
Calculations of electron inelastic mean free paths. XII. Data for 42 inorganic compounds over the 50 eV to 200 keV range with the full Penn algorithm
Authors: Shinotsuka Hiroshi , Tanuma Shigeo , Powell Cedric J. , Penn Dave R. 
Published: December 2018

We have calculated inelastic mean free paths (IMFPs) for 42 inorganic compounds (AgBr, AgCl, AgI, Al2O3, AlAs, AlN, AlSb, cubic BN, hexagonal BN, CdS, CdSe, CdTe, GaAs, GaN, GaP, GaSb, GaSe, InAs, InP, InSb, KBr, KCl, MgF2, MgO, NaCl, NbC0.712, NbC0.844, NbC0.93, PbS, PbSe, PbTe, SiC, SiO2, SnTe, TiC0.7, TiC0.95, VC0.76, VC0.86, Y3Al5O12, ZnS, ZnSe, and ZnTe) for electron energies from 50 eV to 200 keV. These calculations were made with energy‐loss functions (ELFs) obtained from measured optical constants for 15 compounds while calculated ELFs were utilized for the other 27 compounds. Checks based on ELF sum rules showed that the calculated ELFs were superior to the measured ELFs that we had used previously. Our calculated IMFPs could be fitted to a modified form of the relativistic Bethe equation for inelastic scattering of electrons in matter for energies from 50 eV to 200 keV. The average root‐mean‐square (RMS) deviation in these fits was 0.60%. The IMFPs were also compared with a relativistic version of our predictive Tanuma‐Powell‐Penn (TPP‐2M) equation. The average RMS deviation in these comparisons was 10.7% for energies between 50 eV and 200 keV. This average RMS deviation is almost the same as that found in a similar comparison for a group of 41 elemental solids (11.9%) although relatively large deviations were found for cubic BN (65.6%) and hexagonal BN (34.3%). If these two compounds are excluded in the comparisons, the average RMS deviation becomes 8.7%. We found generally satisfactory agreement between our calculated IMFPs and values from other calculations and from experiments.
Current concepts in cochlear ribbon synapse formation
Authors: Coate Thomas M. , Scott M. Katie , Gurjar Mansa 
Published: December 2018

AbstractIn mammals, hair cells and spiral ganglion neurons (SGNs) in the cochlea together are sophisticated “sensorineural” structures that transduce auditory information from the outside world into the brain. Hair cells and SGNs are joined by glutamatergic ribbon‐type synapses composed of a molecular machinery rivaling in complexity the mechanoelectric transduction components found at the apical side of the hair cell. The cochlear hair cell ribbon synapse has received much attention lately because of recent and important findings related to its damage (sometimes termed “synaptopathy”) as a result of noise overexposure. During development, ribbon synapses between type I SGNs and inner hair cells form in the time window between birth and hearing onset and is a process coordinated with type I SGN myelination, spontaneous activity, synaptic pruning, and innervation by efferents. In this review, we highlight new findings regarding the diversity of type I SGNs and inner hair cell synapses, and the molecular mechanisms of selective hair cell targeting. Also discussed are cell adhesion molecules and protein constituents of the ribbon synapse, and how these factors participate in ribbon synapse formation. We also note interesting new insights into the morphological development of type II SGNs, and the potential for cochlear macrophages as important players in protecting SGNs. We also address recent studies demonstrating that the structural and physiological profiles of the type I SGNs do not reach full maturity until weeks after hearing onset, suggesting a protracted development that is likely modulated by activity.
Triclocarban at environmentally relevant concentrations induces the endoplasmic reticulum stress in zebrafish
Authors: Zhou Ting , Wei Jiajing , Su Yufang , Hu Zhiyong , Li Ying , Yuan Hongfang , Zhao Kai , Liu Chunyan , Zhang Huiping 
Published: December 2018

AbstractTriclocarban (TCC) is an antibacterial agent commonly found in environmental, wildlife, and human samples. However, with in‐depth study of TCC, its negative effects are increasingly presented. Toxicological studies of TCC at environmentally relevant concentrations have been conducted in zebrafish embryos and indicated that TCC leads to deformity of development causes developmental deformities. However, the molecular mechanisms underlying the toxicity of TCC in zebrafish embryos have not been entirely elucidated. We investigated whether exposure to TCC at environmentally relevant concentrations induces endoplasmic reticulum (ER) stress and unfolded protein response (UPR) in zebrafish. Zebrafish embryos were grown to 32 hours post fertilization and exposed to 2.5, 5, and 10 μg/L TCC and used in whole‐mount in situ hybridization to visualize the expression of ER chaperone hspa5 and ER stress‐related apoptosis factor chop. Zebrafish livers were exposed to different concentrations of TCC to elaborate the relationships between fatty degeneration and ER stress. Then, a human hepatic cell line (HL‐7702) was used to test whether TCC induced ER stress in human livers similar to those of zebrafish. In zebrafish embryos, TCC induced high hspa5 expression, which could defend against external stimulations. Furthermore, hapa5, hsp90b1, and chop exhibited ectopic expressions in the neuromast, intestinal tract, and tail tip of zebrafish embryos. On the one hand, significant differences were observed in the mRNA and protein expressions of the ER stress molecular chaperone pPERK‐pEIF2a‐ATF4 and ATF6 pathways in HL‐7702 cells exposed to TCC. On the other hand, lipid droplet accumulation slightly increased in zebrafish livers exposed to 10 μg/L TCC in vitro. These results demonstrate that TCC not only damages the development of zebrafish embryos and structure of zebrafish liver but also influences human hepatic cells by activating ER stress and the UPR signaling pathway.
Defining “water resilience”: Debates, concepts, approaches, and gaps
Authors: Rodina Lucy 
Published: December 2018

Resilience is increasingly applied the context of water systems, and water governance more broadly, in response to climate change impacts, hydrologic variability and uncertainty associated with various dimensions of global environmental change. However, the meanings, applications and implications of resilience as it relates to water governance are still poorly understood. Drawing on a systematic scoping review of the peer‐reviewed academic literature, this paper addresses the questions: how is resilience framed in relation to water systems and water governance, how are diverse resilience framings (re)shaping ideas and trends in water management, and what are the associated implications? The analysis found that the resilience‐informed water governance literature remains fragmented and predominantly centered on conventional approaches and framings of water planning, with a predominant focus on engineering resilience in water supply infrastructure. A recently emerging engagement with resilience in the water governance literature, however, draws on more diverse framings and theories and calls for a shift towards more integrative and ecologically‐centered thinking in water governance. Despite this, significant empirical and conceptual gaps remain, particularly around the integration of the various subsectors of water governance and, more importantly, around the institutional and governance dimensions of building water resilience.This article is categorized under:
Engineering Water > Planning Water
Human Water > Water Governance
Quantitative detection method for icing of horizontal‐axis wind turbines
Authors: Zhou Zhihong , Yi Xian , Jiang Wentao , Chen Yu , Tian Xiaobao , Li Weibin , Wang Kaichun , Ma Honglin 
Published: December 2018

AbstractIcing seriously endangers the operational safety of wind turbines, and there has been a lack of research on the quantitative detection and early warning of the icing distribution on a blade. In order to address the present state and specific engineering problems of wind turbines, a method based on external sensor installation is proposed for quantitatively monitoring the icing distribution on a blade through numerical simulation and sensor detection technology. Field tests were performed on 1.5 and 2.0 MW wind turbines in icy weather. The detected distribution and thickness of the blade icing showed good agreement with the field results, which verifies the effectiveness of the detection method. The error between the detected and real ice thicknesses was approximately 20%, which breaks through the limitations of previous qualitative monitoring, and the error for specific ice formations on the blade was within the acceptable range. This new monitoring method can provide a reference for wind turbine icing detection and technical support for the efficient design and effective operation of icing protection facilities.
Spatial characteristics and influencing factors of river pollution in China
Authors: Wang Enru , Li Qian , Hu Hao , Peng Fuli , Zhang Peng , Li Jianjun 
Published: December 2018

AbstractBased on recent water quality data collected from 763 monitoring sections nationwide, this study examined the concentration of major pollutants in China's major rivers. A spatial autocorrelation analysis confirmed that river pollution was spatially uneven and clustered. While pollution of surface water was a nationwide concern, most serious water pollution happened in the Huai, Hai, Yellow, and Liao river Basins in Northern China. The results of the spatial regression analysis showed that GDP per capita, surface water stock, population, and economic structure were all significantly correlated with surface water pollution, with population having strongest impact, followed by level of economic development. By investigating the common characteristics shared by the “hotspot” cities where serious water pollution occurred, this study recommended a regional or basin approach to assessing water quality and controlling river pollution that cuts across jurisdiction boundaries. While China has made considerable progress in improving water productivity, there is still enormous potential in water conservation. It is also imperative to restructure local economy and develop water‐efficient, less polluting industries and services.Practitioner points

River pollution in China was spatially uneven and clustered.

Most serious water pollution happened in the Huai, Hai, Yellow, and Liao river basins in Northern China.

GDP per capita, surface water stock, population, and economic structure correlated with surface water pollution, with population having strongest impact.

A regional or basin approach was recommended to assess water quality and controlling river pollution across jurisdiction boundaries.

It is also imperative to restructure local economy and develop water‐efficient, less polluting industries and services.
A review of the potential of the MinION™ single‐molecule sequencing system for forensic applications
Authors: Plesivkova Diana , Richards Rebecca , Harbison SallyAnn 
Published: December 2018

The use of new sequencing technologies in forensic biology has been explored recently, particularly using Illumina and Ion Torrent platforms. The MinION™, a single‐molecule nanopore sequencer from Oxford Nanopore Technologies™ could advance the field further due to the portability, lower overall instrument cost, and ease of use. This review focuses on exploring applications and the associated benefits and limitations of this technology relative to those currently used in forensic science. The MinION sequences single molecules directly, without amplification, and has the ability to generate long reads in real time. Due to the large amount of sequencing data that the MinION generates, having systems in place for storage and sophisticated analysis tools needs to be considered. The user is able to stop sequencing when the sought after information has been gathered, decreasing the time from sampling to sequence output. Possible forensic applications for the MinION where long sequence reads would be helpful include sequencing whole mitochondrial and bacterial genomes. Sequencing of short tandem repeats and single nucleotide polymorphisms may prove useful for rapid identification at the crime scene. Limitations of the current technology include accuracy of the base calling that has still not reached the standard required for forensic DNA analysis but can be counteracted by read depth and consensus. In addition, the optimum input sample size is currently greater than most real‐world forensic samples. Given the rapid pace of change, future developments by Oxford Nanopore Technologies are likely to overcome these barriers in the coming years.This article is categorized under:

Forensic Biology > Forensic DNA Technologies
Vaccination and Herd Immunity: Individual, Collective, and Institutional Responsibilities
Authors: Giubilini Alberto 
Published: December 2018

AbstractThis chapter discusses the relation between collective, individual, and institutional responsibilities with regard to the realization of herd immunity from certain infectious diseases. The argument is put forth that there is a form of collective moral obligation to realize herd immunity, that there is a principle of fairness in the distribution of the burdens of collective obligations, and that such principle entails that each of us has the individual moral responsibility to make their fair contribution to herd immunity through vaccination. These individual moral obligations, in turn, entail a further individual obligation to support policies aimed at realizing herd immunity. The chapter concludes with a suggestion that the individual moral obligations to support such policies generate an institutional responsibility to implement them.
Introduction
Authors: Frampton Sally 
Published: December 2018

AbstractThis introductory chapter provides an overview of the history of ovariotomy and the significance the operation held within medicine and society. It reviews the place of ovariotomy in the historiography and particularly the interest the operation has garnered from scholars working on gender and women’s history. It then examines the distinctiveness of surgical innovation within medicine and shows how innovation might be used as a conceptual focal point to examine the history of ovariotomy more closely. The chapter sets out the structure of the book, arguing for a more chronologically expansive account of the operation, beginning with its roots in eighteenth-century medicine and which then assesses the changing status and identity of the operation throughout the course of the nineteenth century.
The Afterlife of an Operation
Authors: Frampton Sally 
Published: December 2018

AbstractThis chapter argues for a new way of thinking about the history of surgical innovation that moves beyond simplistic dichotomies of diffusion and failure. Instead it offers an exploration of the ‘afterlife’ of ovariotomy, following the controversies that surrounded the operation towards the end of the century. By the 1890s, the term ‘ovariotomy’ had become increasingly uncertain in its meaning, as a range of other terms emerged to refer to new techniques in ovarian surgery that were being practised. Fears were also growing about the long-term effects upon women’s health of removing the ovaries. ‘Afterlife’ also refers to the formation of ovariotomy as an historical phenomenon during this time, even while it remained in contemporary practice. The historical narrative being developed was part of the innovation process rather than separate from it, as surgeons constructed accounts which posited the operation as an invention of their generation.
Conclusion
Authors: Frampton Sally 
Published: December 2018

AbstractThe concluding chapter argues for the need to nuance histories of surgical novelty and innovation beyond simplistic categories of success and failure and for the cultural and technological implications of surgical innovation to be seen as intertwined rather than separate. It addresses the usefulness of ‘innovation’ as an analytical category, responding to works which have critiqued ‘innovation-centric history’. It argues that no aspect of the innovation process can be treated as self-evident; and that which we might initially take for granted as being unambiguous about an innovation: its beginning, its ending, even its definition, are not necessarily so.
Psychosocial Consequences Among Nurses in the Affected Area of the Great East Japan Earthquake of 2011 and the Fukushima Complex Disaster: A Qualitative Study
Authors: Sato Hideko , Techasrivichien Teeranee , Omori Atsuko , Ono-Kihara Masako , Kihara Masahiro 
Published: December 2018

AbstractObjectiveThe goal of this study was to assess the psychosocial consequences among nurses affected by the Great East Japan Earthquake in order to identify their coping strategies and explore possible countermeasures against complex disasters.MethodsIn 2012, we conducted a qualitative study and screened participants for posttraumatic stress disorder (PTSD).ResultsThirty-eight nurses participated in this study. The result showed a relatively high proportion of probable PTSD (39%). Thirty-two conceptual codes emerged from the data and were grouped into 8 categories: “initial acute stress,” “acute stress turning chronic,” “chronic physical and mental fatigue,” “occupational stress,” “fear of the impact of radiation on children’s health,” “occupational satisfaction,” “positive influences of the disaster experiences,” and “impact of mutual care through interpersonal cognition.”ConclusionsThe study reveals that mutual care may have a positive impact in assisting recovery and enhancing the psychological well-being of nurses. We suggest that disaster management should take into consideration the conflict between professional and family responsibilities. In the light of the chronic impact of the nuclear crisis, enhanced support for interpersonal relationships and human resources, as well as appropriate safety precautions, is urgently needed to help affected nurses. (Disaster Med Public Health Preparedness. 2019;13:519-526)
Neritoptyx hogansoninew species (Gastropoda, Mollusca) from the Upper Cretaceous Fox Hills Formation on the Dakota Isthmus, western United States
Authors: Erickson J. Mark 
Published: December 2018

AbstractIn midcontinent North America, the Fox Hills Formation (Upper Cretaceous, upper Maastrichtian) preserves the last marine faunas in the central Western Interior Seaway (WIS).Neritoptyx hogansoninew species, a small littoral snail, exhibited allometric change from smooth to corded ornament and rounded to shouldered shape during growth. Specimens preserve a zig-zag pigment pattern that changes to an axial pattern during growth.Neritoptyx hogansoninew species was preyed on by decapod crustaceans, and spent shells were occupied by pagurid crabs. Dead mollusk shells, particularly those ofCrassostrea subtrigonalis(Evans and Shumard, 1857), provided a hard substrate to which they adhered on the Fox Hills tidal flats. This new neritimorph gastropod establishes a paleogeographic and chronostratigraphic proxy for intertidal conditions on the Dakota Isthmus during the late Maastrichtian. Presence of a neritid extends the marine tropical/temperate boundary in the WIS northward to ~44° late Maastrichtian paleolatitude. Late Maastrichtian closure of the isthmus subsequently altered marine heat transfer by interrupting northward flow of tropical currents from the Gulf Coast by as much as 1 to 1.5 million years before the Cretaceous ended.UUID:http://zoobank.org/3ba56c07-fcca-4925-a2f0-df663fc3a06b
Street Theater: Building Monumental Avenues in Roman Ephesus and Renaissance Florence
Authors: Ryan Garrett 
Published: December 2018

AbstractBetween the late first and the mid-third century CE, local elites in the eastern provinces of the Roman Empire lined the formerly utilitarian streets of their cities with honorific statues, colonnades, and ornamental buildings. The monumental avenues thus created have usually been interpreted as unplanned products of competitive munificence. This article, by contrast, suggests that the new streets had real political significance. It compares the monumental avenues of Roman Ephesus with a formal analogue from a better-documented historical context: the long, colonnaded courtyard of Florence's Uffizi complex, constructed by Duke Cosimo I in the mid-sixteenth century. Comparison with the Uffizi courtyard illuminates the prominence of “democratic” architectural conventions in Ephesian monumental avenues, the elite-centric vision of civic history implicit in their sculptural displays, and the degree to which public ceremonies reinforced their political messages.