bluuebunny/crossref_metadata_2025_split huggingface dataset:
New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions
Authors: Uemura Nobuo , Kasanuki Hiroshi , Umezu Mitsuo 
Published: April 2021

Abstract
Objective
The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA).
To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization.

Method
We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme.

Results
By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function.

Conclusions
The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.
A comparative study of conventional and tri-lobed stratospheric airships
Authors: Manikandan M. , Pant R.S. 
Published: April 2021

AbstractThe design and development of Stratospheric Airships for High-Altitude Long-Endurance missions (HALESAs) has generated interest worldwide. Conventional airships usually have a single-lobed axisymmetrical envelope shape. In contrast, several non-axisymmetric envelope configurations have been proposed for the HALESAs, such as flattened single lobed and multi lobed. This paper describes a methodology for carrying out a comparative analysis of a conventional HALESA and the multi-lobed HALESA designed for the same design mission. A sizing methodology which enables the estimation of its design parameters to meet some user-specified requirements has been developed for airships with envelopes of both these shapes. A Multidisciplinary Design Optimisation (MDO) approach has been followed in this methodology, which includes considerations from the disciplines of aerodynamics, energy, environment and structures. The study indicates that the envelope volume, solar array area and total mass of the single-lobed conventional airship are better than those of the tri-lobed HALESA. While the multi-lobed HALESA has the advantage of a flatter upper surface resulting in higher efficiency of the solar panels, the conventional airship has lower drag, which results in superior mission performance.
Discriminative Utility of Transcranial Magnetic Stimulation-Derived Markers of Cortical Excitability for Transient Ischemic Attack
Authors: Edwards Jodi D. , Ferris Jennifer K. , Gao Fuqiang , Honjo Kie , Boyd Lara A. 
Published: April 2021

ABSTRACT:Background:Several guidelines currently recommend acute diffusion weighted imaging (DWI) for the detection of ischemia in transient ischemic attack (TIA). However, DWI hyperintensities resolve early and only 30%–50% with clinically defined TIA show acute DWI positivity. A recent meta-analysis reported an unexplained 7-fold variation in DWI positivity in TIA across studies, concluding that DWI does not provide a consistent basis for defining ischemia. Intracortical excitability, measured using transcranial magnetic stimulation (TMS), has previously been shown to be altered after TIA and associated with ABCD2 scores; however, whether altered cortical excitability is associated with clinical and DWI-based definitions of TIA remains unclear.Methods:Individuals with TIA symptoms (N = 23; mean age = 61 ± 12) were prospectively recruited and underwent DWI and paired-pulse TMS. Multivariate linear regression was used to estimate associations between TMS-derived excitability thresholds, and clinical TIA diagnosis, and imaging-based evidence of cerebral ischemia (DWI positivity). Area under the curve (AUC) analyses was used to compare the discriminability of TMS-derived thresholds and clinical TIA diagnoses.Results:Thresholds for intracortical inhibition in the TIA-unaffected hemisphere were significantly associated with the clinical diagnosis of TIA. No associations between TMS-derived thresholds and DWI positivity were observed. TMS thresholds showed low-moderate discriminability and values differed by age (65+) and sex.Conclusions:In this small sample, TMS-derived markers of intracortical excitability were associated with clinical TIA diagnoses but not DWI positivity. Our results provide preliminary evidence for the potential discriminative utility of TMS for the diagnosis of TIA and highlight the need for future work in larger cohorts.
Effects of the COVID-19 Pandemic on Parkinson’s Disease: a Single-Centered Qualitative Study
Authors: Anghelescu Beatrice Ana-Maria , Bruno Veronica , Martino Davide , Roach Pamela 
Published: April 2021

ABSTRACT:Background:The public health measure restrictions across the world due to COVID-19 have inadvertently impacted the routines for people with Parkinson’s disease (PD) and their care partners not only in terms of compromised neurological clinical care but also drastically changing the way of life to minimize the risk of becoming infected. This study explores initial PD patients’ lived experiences to observe how quality of life and health care has been affected at the start of the COVID-19 pandemic and provide insight into the importance of patient engagement and virtual care.Methods:Twenty-two virtual, in-depth semi-structured interviews with persons diagnosed with PD who usually attend a Movement Disorders specialty clinic in Calgary, Alberta, were completed between April 28 and May 13, 2020, and the care partners that wished to participate. Interviews were recorded and transcribed, after which transcripts were analyzed and coded into relevant themes using NVivo 12.Results:Impacts from the public health measures and COVID-19 results into three main themes: (1) Impacts of COVID-19 on PD Clinical Care; (2) Activities of Daily Living; (3) Attitudes and Perceptions. Participants reported worsening in motor and nonmotor symptoms and had to accommodate to clinical care via virtual means which were associated with limitations and suggestions for improvement of remote care.Conclusion:This study provides a unique opportunity for researchers to better understand the lived experiences of PD patients in all aspects of their life suggesting that innovative means are needed for facilitating virtual health care medicine and increased social interaction.
Feature extraction and artificial neural networks for the on-the-fly classification of high-dimensional thermochemical spaces in adaptive-chemistry simulations
Authors: D’Alessio Giuseppe , Cuoci Alberto , Parente Alessandro 
Published: April 2021

Abstract
The integration of Artificial Neural Networks (ANNs) and Feature Extraction (FE) in the context of the Sample- Partitioning Adaptive Reduced Chemistry approach was investigated in this work, to increase the on-the-fly classification accuracy for very large thermochemical states. The proposed methodology was firstly compared with an on-the-fly classifier based on the Principal Component Analysis reconstruction error, as well as with a standard ANN (s-ANN) classifier, operating on the full thermochemical space, for the adaptive simulation of a steady laminar flame fed with a nitrogen-diluted stream of n-heptane in air. The numerical simulations were carried out with a kinetic mechanism accounting for 172 species and 6,067 reactions, which includes the chemistry of Polycyclic Aromatic Hydrocarbons (PAHs) up to C

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. Among all the aforementioned classifiers, the one exploiting the combination of an FE step with ANN proved to be more efficient for the classification of high-dimensional spaces, leading to a higher speed-up factor and a higher accuracy of the adaptive simulation in the description of the PAH and soot-precursor chemistry. Finally, the investigation of the classifier’s performances was also extended to flames with different boundary conditions with respect to the training one, obtained imposing a higher Reynolds number or time-dependent sinusoidal perturbations. Satisfying results were observed on all the test flames.
Limited impact of an ultraviolet disinfection intervention on hygienic behaviors of nursing staff in a military hospital
Authors: Blanchard Dawn M. , Resendiz Marisol , Lustik Michael B. , West Gordon F. 
Published: April 2021

AbstractUltraviolet disinfection (UV-C), though effective, has not been thoroughly evaluated at the level of the clinical end user. We assessed behavioral outcomes related to environmental hygiene among 60 nursing staff in a medical-surgical section after introduction of a UV-C tool aimed at disinfecting 4 high-touch surfaces, and we noted limited changes.
Dimensions of globalisation and social welfare policies in Organisation for Economic Co-operation and Development countries
Authors: Santos Marcelo , Simões Marta 
Published: April 2021

AbstractWhich dimensions of globalisation have an impact on social expenditure? How do different social welfare policies react to globalisation? This paper addresses these questions focusing on 36 Organisation for Economic Co-operation and Development countries over the period 1990–2015 and applying system Generalised Method of Moments to deal with endogeneity. We consider different dimensions of globalisation, economic, social and political, and their potential differentiated impacts on variegated social welfare policies. According to our findings, all the dimensions of globalisation have a positive effect on total social expenditure and on most of its components, although the influence is not statistically significant for social globalisation. The social welfare policies affected by globalisation are old age pensions, incapacity related, family and unemployment benefits and active labour market policies. These results can shed additional light on social and economic outcomes of globalisation such as poverty, inequality, long run growth and economic recovery.
TheArabidopsisembryo as a quantifiable model for studying pattern formation
Authors: Harnvanichvech Yosapol , Gorelova Vera , Sprakel Joris , Weijers Dolf 
Published: April 2021

AbstractPhenotypic diversity of flowering plants stems from common basic features of the plant body pattern with well-defined body axes, organs and tissue organisation. Cell division and cell specification are the two processes that underlie the formation of a body pattern. As plant cells are encased into their cellulosic walls, directional cell division through precise positioning of division plane is crucial for shaping plant morphology. Since many plant cells are pluripotent, their fate establishment is influenced by their cellular environment through cell-to-cell signaling. Recent studies show that apart from biochemical regulation, these two processes are also influenced by cell and tissue morphology and operate under mechanical control. Finding a proper model system that allows dissecting the relationship between these aspects is the key to our understanding of pattern establishment. In this review, we present theArabidopsisembryo as a simple, yet comprehensive model of pattern formation compatible with high-throughput quantitative assays.
Dickinsonia: mobile and adhered
Authors: Ivantsov Andrey , Zakrevskaya Maria 
Published: April 2021

AbstractThe classical genus of Ediacaran macroorganisms,Dickinsonia, was part of an extensive benthic marine community inhabiting the fields of microbial mats. The remains ofDickinsoniaare commonly preserved in the position of adhesion to the habitat substrate. However, these were mobile organisms. In addition to the already known feeding traces ofDickinsonia, structures described as traces of motor activity are reported. Long parallel furrows, extending from the posterior end of the body imprint, are interpreted as imprints of ridges left by an organism moving along the surface of the substrate. Groups of differently shaped grooves laying in the depression that enhalo theDickinsoniabody imprints or accompany their individual areas are interpreted as imprints of ridges and cords of mucous material. They are considered to represent structures of self-determined stretching and lift-off of the body margins from the substrate. The rings and arcs of silt- and sand-sized mineral particles bordering the body imprints are composed of material that was supposedly brushed off from the surface of the microbial mat byDickinsonia. They are considered traces of the adhesion of these organisms to the substrate. Accumulations of multidirectional pulling and tear-off structures, lacking the body imprint but accompanied by the joint plane passing into the overlying sediment and cutting through the bedding, are interpreted as escape traces. The dual modality of the behaviour (attachment and mobility) could indicate the adaptability ofDickinsoniato life in extremely shallow-water environments.
Globalization, Institutions, and Ethnic Inequality
Authors: Bormann Nils-Christian , Pengl Yannick I. , Cederman Lars-Erik , Weidmann Nils B. 
Published: April 2021

AbstractRecent research has shown that inequality between ethnic groups is strongly driven by politics, where powerful groups and elites channel the state's resources toward their constituencies. Most of the existing literature assumes that these politically induced inequalities are static and rarely change over time. We challenge this claim and argue that economic globalization and domestic institutions interact in shaping inequality between groups. In weakly institutionalized states, gains from trade primarily accrue to political insiders and their co-ethnics. By contrast, politically excluded groups gain ground where a capable and meritocratic state apparatus governs trade liberalization. Using nighttime luminosity data from 1992 to 2012 and a global sample of ethnic groups, we show that the gap between politically marginalized groups and their included counterparts has narrowed over time while economic globalization progressed at a steady pace. Our quantitative analysis and four qualitative case narratives show, however, that increasing trade openness is associated with economic gains accruing to excluded groups in only institutionally strong states, as predicted by our theoretical argument. In contrast, the economic gap between ethnopolitical insiders and outsiders remains constant or even widens in weakly institutionalized countries.
Rising Inequality As a Threat to the Liberal International Order
Authors: Flaherty Thomas M. , Rogowski Ronald 
Published: April 2021

AbstractThe rise of top-heavy inequality—earnings concentration in a very thin layer of elites—calls into question our understanding of the distributional effects of the Liberal International Order. Far more people lose from globalization, and fewer gain, than traditional economic models suggest. We review three modern trade theories (neo-Heckscher-Ohlin-Stolper-Samuelson or H-O-S-S, new new trade theory, and economic geography) that each arrive at the conclusion of top-heavy inequality by introducing some form of unit heterogeneity—an assumption that the actors we once treated as identical actually differ from one another in important ways. Heterogeneity allows the gains from globalization to concentrate in a narrow segment of workers with superlative talents, extraordinarily productive firms, or heavily agglomerated cities. An analysis of European voting data shows that shocks from trade and migration elicit populist opposition only where the top 1 percent have gained the most. With few politically feasible alternatives to protectionism, most notably the failure of democracies to redistribute income, our analysis predicts a persistence of public support for antiglobalization parties, especially those on the Right.
THE SORCERER'S APPRENTICE: SLEEPING SICKNESS, ONCHOCERCIASIS, AND UNINTENDED CONSEQUENCES IN GHANA, 1930–60
Authors: Bannister David 
Published: April 2021

AbstractThe Northern Territories Protectorate and its people were located on the economic and political margins of Britain's Gold Coast Crown Colony (now Ghana) throughout the colonial period. The article examines how the region's peripherality allowed the Gold Coast Tsetse Control Department to carry out an extensive campaign of bush clearing and resettlement along northern river valleys from the 1930s to 1950s, with little supervision by the Gold Coast Medical Department or northern officials. Intended to control human and animal sleeping sickness and to meet the economic preferences of the colony's central administration, this campaign had the effect of greatly increasing the exposure of northern communities to another disease, onchocerciasis, causing widespread blindness and contributing to a serious public health crisis in the early independence era.
Contour clustering: A field-data-driven approach for documenting and analysing prototypical f0 contours
Authors: Kaland Constantijn 
Published: April 2021

ABSTRACTThis paper reports an automatic data-driven analysis for describing prototypical intonation patterns, particularly suitable for initial stages of prosodic research and language description. The approach has several advantages over traditional ways to investigate intonation, such as the applicability to spontaneous speech, language- and domain-independency, and the potential of revealing meaningful functions of intonation. These features make the approach particularly useful for language documentation, where the description of prosody is often lacking. The core of this approach is a cluster analysis on a time-series of f0 measurements and consists of two scripts (Praat and R, available fromhttps://constantijnkaland.github.io/contourclustering/). Graphical user interfaces can be used to perform the analyses on collected data ranging from spontaneous to highly controlled speech. There is limited need for manual annotation prior to analysis and speaker variability can be accounted for. After cluster analysis, Praat textgrids can be generated with the cluster number annotated for each individual contour. Although further confirmatory analysis is still required, the outcomes provide useful and unbiased directions for any investigation of prototypical f0 contours based on their acoustic form.
Good reasons for losers: lottery justification and social risk
Authors: Spiekermann Kai 
Published: April 2021

AbstractMany goods are distributed by processes that involve randomness. In lotteries, randomness is used to promote fairness. When taking social risks, randomness is a feature of the process. The losers of such decisions ought to be given a reason why they should accept the outcome. Surprisingly, good reasons demand more than merely equalex antechances. What is also required is a true statement of the form: ‘the result could easily have gone the other way and you could have been the winner’. This rules in standard lotteries but rules out many lotteries based on merely epistemic probability.
Life as a Trust Game: a comment on The Option Value of Life
Authors: Ponthiere Gregory 
Published: April 2021

AbstractAccording to Burri (2020), a major reason why suicide is often irrational lies in the option value of life. Remaining alive is valuable because this allows for a larger menu of options, and the possibility of committing suicide in the future adds further value to the act of remaining alive now. In this note, I represent life as a trust game played by two selves – the young self and the old self – and I argue that the possibility to commit suicide in the future can encourage committing suicide now, against what the theory of the option value of life predicts.
Establishment and implementation of hospital-based health technology assessment at King Hussein Cancer Center: can our model be an example?
Authors: Al-Rabayah Abeer A. , Jaddoua Saad M. 
Published: April 2021

Abstract

Objective
To describe the establishment of, and assess the implementation of, a hospital-based health technology assessment (HTA) program in a comprehensive cancer center in Jordan.

Methods
This is a cross-sectional assessment study of the HTA program from 2008 to 2018. We used an indicator-based assessment that included structural, process, and outcome indicators. Structural indicators measured the program's enablers. Process indicators measured activities and outputs, whereas outcome indicators measured the program impact. A data collection form was prepared to collect data related to each indicator.

Results
The program met its core structural and process indicators. The Center for Drug Policy and Technology Assessment was established as an organizational entity to conduct assessments. A functional decision-making entity is available. There are competent pharmacists to conduct assessments, including economic evaluation and decision analytical modeling. There is a structured capacity building program that has been implemented within the last 5 years. Specific submission, assessment, and appraisal processes were established and implemented. Reference methodological guidelines for efficacy, safety, and cost-effectiveness assessments were developed and used by assessors. Thirty-one HTA reports were produced from 2012 to 2018 with a 100 percent utilization rate. Twenty-three medications were listed under restriction, and eight were rejected. The prices of twenty-one medications out of the twenty-three listed medications were reduced based on the HTA assessment results.

Conclusion
The HTA program at the King Hussein Cancer Center (KHCC) in Jordan is functional, is effective with a high utilization rate of produced assessments, and is having a positive impact on price reductions.
The less considered part: Contextualizing immaterial heritage from German colonial contexts in the restitution debate
Authors: Kalibani Mèhèza 
Published: April 2021

AbstractSince the publication of the “restitution report” by Felwine Sarr and Bénédicte Savoy in November 2018, the debate around the restitution of African artifacts inherited from German colonialism in German museums has become increasingly intense. While the restitution debate in Germany is generally focused on “material cultural heritage” and human remains, this reflection attempts to contextualize the “immaterial heritage” (museum collections inventory data, photographs, movies, sound recordings, and digital archive documents) from German colonialism and plead for its consideration in this debate. It claims that the first step of restitution consists of German ethnological museums being transparent about their possessions of artifacts from colonial contexts, which means providing all available information about museum collections from colonial contexts and making them easily accessible to the people from the former German colonies.