bluuebunny/crossref_metadata_2025_split huggingface dataset:
Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn’s Disease
Authors: Hanzel Jurij , Jairath Vipul , De Cruz Peter , Guizzetti Leonardo , Shackelton Lisa M , Bossuyt Peter , Duijvestein Marjolijn , Dulai Parambir S , Grossmann Johannes , Hirten Robert P , Khanna Reena , Panes Julian , Peyrin-Biroulet Laurent , Regueiro Miguel , Rubin David T , Singh Siddharth , Stidham Ryan W , Sandborn William J , Feagan Brian G , D’Haens Geert R , Ma Christopher 
Published: November 2021

Abstract

Background
The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn’s disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.

Methods
An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds.

Results
Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain.

Conclusions
A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.
Strategies to Distinguish Perianal Fistulas Related to Crohn’s Disease From Cryptoglandular Disease: Systematic Review With Meta-Analysis
Authors: Chin Koon Siw Kevin , Engel Jake , Visva Samantha , Mallick Ranjeeta , Hart Ailsa , de Buck van Overstraeten Anthony , McCurdy Jeffrey D 
Published: November 2021

Abstract

Background
Management of perianal fistulas differs based on fistula type. We aimed to assess the ability of diagnostic strategies to differentiate between Crohn’s disease (CD) and cryptoglandular disease (CGD) in patients with perianal fistulas.

Methods
We performed a diagnostic accuracy systematic review and meta-analysis. A systematic search of electronic databases was performed from inception through February 2021 for studies assessing a diagnostic test’s ability to distinguish fistula types. We calculated weighted summary estimates with 95% confidence intervals for sensitivity and specificity by bivariate analysis, using fixed effects models when data were available from 2 or more studies. The Quality Assessment of Diagnostic Accuracy Studies tool was used to assess study quality.

Results
Twenty-one studies were identified and included clinical symptoms (2 studies; n=154), magnetic resonance imaging (MRI) characteristics (3 studies; n=296), ultrasound characteristics (7 studies; n=1003), video capsule endoscopy (2 studies; n=44), fecal calprotectin (1 study; n=56), and various biomarkers (8 studies; n=440). MRI and ultrasound characteristics had the most robust data. Rectal inflammation, multiple-branched fistula tracts, and abscesses on pelvic MRI and the Crohn’s ultrasound fistula sign, fistula debris, and bifurcated fistulas on pelvic ultrasonography had high specificity (range, 80%-95% vs 89%-96%) but poor sensitivity (range, 17%-37% vs 31%-63%), respectively. Fourteen of 21 studies had risk of bias on at least 1 of the Quality Assessment of Diagnostic Accuracy Studies domains.

Conclusions
Limited high-quality evidence suggest that imaging characteristics may help discriminate CD from CGD in patients with perianal fistulas. Larger, prospective studies are needed to confirm these findings and to evaluate if combining multiple diagnostic tests can improve diagnostic sensitivity.
Epidemiology and Natural History of Perianal Crohn’s Disease: A Systematic Review and Meta-Analysis of Population-Based Cohorts
Authors: Tsai Lester , McCurdy Jeffrey D , Ma Christopher , Jairath Vipul , Singh Siddharth 
Published: November 2021

Abstract

Background and Aims
Perianal Crohn’s disease (pCD) is a potentially severe phenotype of CD. We conducted a systematic review with meta-analysis to estimate cumulative incidence, risk factors, and outcomes of pCD in population-based cohort studies.

Methods
Through a systematic literature review through March 1, 2021, we identified population-based inception cohort studies reporting cumulative incidence of perianal disease (primarily abscess and/or fistula) in patients with CD. We estimated the cumulative incidence of pCD at presentation and 1-, 5-, and 10-year follow-up, and risk factors for perianal disease and outcomes including risk of major (bowel resection, proctectomy, ostomy) and minor perianal (incision and drainage, seton placement, etc.) surgery.

Results
In 12 population-based studies, prevalence of pCD was 18.7% (95% confidence interval [CI], 12.5%-27.0%) with 1-, 5-, and 10-year risk of perianal disease being 14.3% (95% CI, 7.9%-24.6%), 17.6% (95% CI, 11.3%-26.5%), and 18.9% (95% CI, 15.0%-23.4%), respectively. Approximately 11.5% of patients (95% CI, 6.7%-19.0%) had perianal disease at or before CD diagnosis. Colonic disease location and rectal involvement were associated with higher risk of pCD. Overall, 63.3% of patients (95% CI, 53.3-72.3) required minor perianal surgery and 6.4% of patients (95% CI, 1.8%-20.6%) required major abdominal surgery for pCD. Use of biologic therapy for pCD is common and has steadily increased throughout the years.

Conclusions
Approximately 1 in 5 patients with CD develops perianal disease within 10 years of CD diagnosis, including 11.5% who have perianal disease at presentation. Approximately two-thirds of patients require perianal surgery, with a smaller fraction requiring major abdominal surgery.
Behind a Digital Mask: Users’ Subjective Experience of Animated Characters and Its Effect on Source Credibility
Authors: Di Natale Anna Flavia , Triberti Stefano , Sibilla Federica , Imperato Chiara , Villani Daniela , Mancini Tiziana , Riva Giuseppe 
Published: November 2021

Abstract
Recently, computer-mediated communication has incorporated animated characters (ACs) as interface technologies. These digital entities are animated by mimicry and can be used either to deliver pre-recorded messages or to live communicate with others. The interlocutors can choose the physical appearance of the character and decide to use a character that may or may not represent their actual self. In this respect, it is important to investigate the psychological mechanisms describing how the user responds to ACs and the resulting effects on communication. To do this, a 2 × 2 experiment was conducted (n = 85) to evaluate the effects of human-likeness (human-like vs. non-human-like) and self-representation (actual self vs. ideal self) on users’ subjective experience, in terms of para-social relationship, identification and emotions, and its effect on communication-related variables such as source credibility. Results showed that, unlike self-representation, human-likeness had a significant effect on the interaction between the user and an AC, with non-human-like ACs stimulating a more engaging and positive interaction compared with human-like ACs. Data also confirmed the importance of para-social relationship and identification in fostering source credibility. Theoretical and practical implications are discussed.
Rapid Screening of β-Agonists in Animal Hair by Thermal Desorption Electrospray Ionization Mass Spectrometry
Authors: Zhang Hongyan , Chang Qiaoying , Wu Xingqiang , Qiu Guoyu , Li Jian , Wu Fuxiang 
Published: November 2021

Abstract

Background
Even though the use of β-agonists in livestock has been banned in many countries, β-agonists abuse is still out of control owing to time-consuming and complicated determination techniques.

Objective
This study applied ambient thermal desorption electrospray ionization mass spectrometry (TD-ESI/MS) as a new strategy for rapidly screening seven β-agonists. As it does not require pretreatment, this method allows on-site and real-time detection.

Method
Samples were collected directly using a simple metal probe. Analytes on the probe were desorbed and ionized by TD-ESI, after which analyte ions were detected using a triple quadrupole mass analyser.

Results
The results showed that a thermal desorption temperature of 320°C and nebulizer pressure of 3 psi demonstrated the highest sensitivity. Excellent linear relationships were obtained in concentrations ranging from 10 to 400 μg/kg. The limit of detection of the method was 1–10 μg/kg with RSDs of 7.2–14.6%. A positive sample was verified using HPLC coupled with triple quadrupole tandem mass spectrometry, consistent with the results from TD-ESI/MS.

Conclusion
This method was the first to apply TD-ESI/MS to rapid analyse β-agonists in livestock hair and was proven to be accurate, fast, and environmentally friendly. Because qualitative screening for each analysis was completed within approximately 1 min, the method could contribute to preventing non-compliance in the flow of animal-derived food to the market.

Highlights
This method was a promising method for the rapid screening of β-agonists in livestock hair at any time of breeding without imposing any harm to animal which proven to be a rapid, in situ, and non-destructive detection technique without any pretreatment.
Early Transcriptomic Response to Burn Injury: Severe Burns Are Associated With Immune Pathway Shutdown
Authors: Keyloun John W , Campbell Ross , Carney Bonnie C , Yang Ruoting , Miller Stacy-Ann , Detwiler Leanne , Gautam Aarti , Moffatt Lauren T , Hammamieh Rasha , Jett Marti , Shupp Jeffrey W ,   SYSCOT study group, McLawhorn Melissa M , Callcut Rachael A , Cohen Mitchell J , Petzold Linda R , Varner Jeffrey D , Bravo Maria Cristina , Brummel-Ziedins Kathleen E , Freeman Kalev , Mann Kenneth G , Orfeo Thomas , Pusateri Anthony E 
Published: November 2021

Abstract
Burn injury induces a systemic hyperinflammatory response with detrimental side effects. Studies have described the biochemical changes induced by severe burns, but the transcriptome response is not well characterized. The goal of this work is to characterize the blood transcriptome after burn injury. Burn patients presenting to a regional center between 2012 and 2017 were prospectively enrolled. Blood was collected on admission and at predetermined time points (hours 2, 4, 8, 12, and 24). RNA was isolated and transcript levels were measured with a gene expression microarray. To identify differentially regulated genes (false-discovery rate ≤0.1) by burn injury severity, patients were grouped by TBSA above or below 20% and statistically enriched pathways were identified. Sixty-eight patients were analyzed, most patients were male with a median age of 41 (interquartile range, 30.5–58.5) years, and TBSA of 20% (11%–34%). Thirty-five patients had % TBSA injury ≥20%, and this group experienced greater mortality (26% vs 3%, P = .008). Comparative analysis of genes from patients with &lt;/≥20% TBSA revealed 1505, 613, 380, 63, 1357, and 954 differentially expressed genes at hours 0, 2, 4, 8, 12, and 24, respectively. Pathway analysis revealed an initial up-regulation in several immune/inflammatory pathways within the ≥20% TBSA groups followed by shutdown. Severe burn injury is associated with an early proinflammatory immune response followed by shutdown of these pathways. Examination of the immunoinflammatory response to burn injury through differential gene regulation and associated immune pathways by injury severity may identify mechanistic targets for future intervention.
Repair, Consumption, and Sustainability: Fixing Fragile Objects and Maintaining Consumer Practices
Authors: Godfrey D Matthew , Price Linda L , Lusch Robert F 
Published: November 2021

AbstractRepair is an overlooked but important aspect of consumer behavior with implications for the social and environmental sustainability of consumption. This ethnographic study examines the interplay of repair and consumption by analyzing when and how consumers repair the objects they use. The analysis examines how conflicting and complementary practice elements can lead to object replacement and disposal or, alternatively, facilitate object repair and extended use. Results unfold how consumers calibrate their routine activities around the continually changing material capacities of objects. Consumers engage in repair as a response to worn or damaged objects that misalign from and often disrupt ongoing practices. Repairers, including consumers and professional service providers, attempt to adjust object capacities in ways that realign disrupted practices with the routinized ways that consumers do them. When successful, repair sustains consumer practices by avoiding prolonged disruption and unnecessary waste. However, conflicts between production, consumption, and repair can hinder the efficacy of repair interventions and shape whether and how consumers repair the objects they use. The article explains these challenges and concludes by discussing their implications for studies of repair, consumer practices, and sustainable consumption.
Three Decades of the Nakajima Doctrine in EU Law: Where Are We Now?
Authors: Stoyanov Kristiyan 
Published: November 2021

ABSTRACT
Under the Nakajima doctrine, the Court of Justice of the European Union (CJEU) can review the legality of a European Union (EU) measure in the light of the World Trade Organization (WTO) agreements if the EU legislature intended to implement a particular obligation assumed in the context of those agreements. This article argues that Nakajima remains a valid exception to the lack of direct effect of WTO law in the EU. Section II highlights the CJEU’s restrictive interpretation of Nakajima. Section III shows that in recent case law the CJEU continues to take a narrow interpretation of Nakajima, although the CJEU has been reluctant to abolish it altogether. This section also analyses the feasibility of establishing the intention to implement WTO law based on external circumstances (Section III.B) and demonstrates Nakajima’s significance beyond EU law (Section III.C). Section IV criticizes the CJEU’s combination of Nakajima and the principle of interpreting EU law in consistency with international law. Section V concludes.
Utilization of West Virginia Pediatric Medicaid Claims Data to Guide Outpatient Antimicrobial Stewardship Interventions
Authors: Kilgore Jacob T , Lanata Mariana M , Willis Jonathan M , McCarthy Michael J , Becker James B , Evans Joseph E , Smith Michael J 
Published: November 2021

Abstract
West Virginia consistently ranks in the top two nationally for per capita antibiotic prescription rates in both pediatric and adult outpatient populations. We present the first descriptive analysis evaluating outpatient prescription rates within the WV pediatric Medicaid population, which demonstrated significant antibiotic prescribing variability by provider type, specialty, and geography.
The updated basti stellar evolution models and isochrones – III. White dwarfs
Authors: Salaris Maurizio , Cassisi Santi , Pietrinferni Adriano , Hidalgo Sebastian 
Published: November 2021

ABSTRACT
We present new cooling models for carbon–oxygen white dwarfs (WDs) with both H- and He-atmospheres, covering the whole relevant mass range, to extend our updated basti (a Bag of Stellar Tracks and Isochrones) stellar evolution archive. They have been computed using core chemical stratifications obtained from new progenitor calculations, adopting a semi-empirical initial–final mass relation. The physics inputs have been updated compared to our previous basti calculations: 22Ne diffusion in the core is now included, together with an updated CO phase diagram, and updated electron conduction opacities. We have calculated models with various different neon abundances in the core, suitable to study WDs in populations with metallicities ranging from supersolar to metal poor, and have performed various tests/comparisons of the chemical stratification and cooling times of our models. Two complete sets of calculations are provided, for two different choices of the electron conduction opacities, to reflect the current uncertainty in the evaluation of the electron thermal conductivity in the transition regime between moderate and strong degeneracy, crucial for the H- and He-envelopes. We have also made a first, preliminary estimate of the effect – that turns out to be generally small – of Fe sedimentation on the cooling times of WD models, following recent calculations of the phase diagrams of carbon–oxygen-iron mixtures. We make publicly available the evolutionary tracks from both sets of calculations, including cooling times and magnitudes in the Johnson-Cousins, Sloan, Pan-STARSS, GALEX, Gaia-DR2, Gaia-eDR3, HST-ACS, HST-WFC3, and JWST photometric systems.
A 6D view of stellar shells
Authors: Dong-Páez C A , Vasiliev E , Evans N W 
Published: November 2021

ABSTRACT
Stellar shells are low surface brightness features, created during nearly head-on galaxy mergers from the debris of the tidally disrupted satellite. Here, we investigate the formation and evolution mechanism of shells in six dimensions (3D positions and velocities). We propose a new description in action-angle coordinates which condenses the seemingly complex behaviour of an expanding shell system into a simple picture, and stresses the crucial role of the existence of different stripping episodes in the properties of shells. Based on our findings, we construct a method for constraining the potential of the host galaxy and the average epoch of stripping. The method is applicable even if the shells cannot be identified or isolated from the data, or if the data are heavily contaminated with additional foreground stars. These results open up a new possibility to study the ancient merger that built the Milky Way Galaxy’s stellar halo.
The second decametre pulsar census at the UTR-2
Authors: Kravtsov Ihor P , Zakharenko Vyacheslav V , Ulyanov Oleg M , Shevtsova Alisa I , Yerin Serge M , Konovalenko Oleksandr O 
Published: November 2021

ABSTRACT
In this paper, we present the results of the second census of pulsars in the decametre wave range at the Ukrainian T-shaped Radio telescope, second modification (UTR-2). Over the past 10 yr, the worldwide number of discovered nearby pulsars has doubled, which means that there is some urgency to search for a low-frequency radio emission from these newly discovered sources. To increase the sensitivity of this census, the integration time was doubled compared with the first census of 2010–2013. As a result, the decametre radio emission of 20 pulsars was detected, and their flux densities and the shape of their pulses were obtained. The dispersion measures for 10 pulsars and the rotation periods for eight pulsars were refined. For several pulsars, the scattering time constant and FWHM were estimated in the decametre wave range. The upper limits of flux densities for 102 pulsars that have not yet been detected were also estimated.
Monte Carlo simulations of evolving rotational distributions of low-mass stars in young open clusters. Testing the influence of initial conditions
Authors: Vasconcelos M J , Bouvier J , Gallet F , Luz Filho E A 
Published: November 2021

ABSTRACT
The rotational evolution of a young stellar population can give informations about the rotation pattern of more evolved clusters. Combined with rotational period values of thousands of young stars and theoretical propositions about the redistribution and loss of stellar angular momentum, it allows us to trace the rotational history of stars according to their mass. We want to investigate how internal and environmental changes on single stars can change the rotational evolution of a young stellar population. We run Monte Carlo simulations of a young cluster composed by solar mass stars of 0.5, 0.8 and 1.0 M⊙ from 1 to 550 Myr taking into account observational and theoretical parameters. In order to compare our results with the observations we run Kolmogorov-Smirnov tests. Our standard model is able to reproduce some clusters younger than h Per and marginally M37, which is 550 Myr old. Varying the disk fraction or the initial period distribution did not improve the results. However, when we run a model with a finer mass grid the Pleiades can be also reproduced. Changing the initial mass distribution to be similar to the empirical ONC mass function also gives good results. Modeling the evolution of a young synthetic cluster from pre-main sequence to early main sequence considering physical mechanisms of extraction and exchange of angular momentum can not be achieved successfully for all clusters for which we have enough rotational data. Clusters of about the same age present different rotational behaviors due perhaps to differences in their initial conditions.
The ZTF-BTS Type Ia supernovae luminosity function is consistent with a single progenitor channel for the explosions
Authors: Sharon Amir , Kushnir Doron 
Published: November 2021

ABSTRACT
We construct the Type Ia supernovae (SNe Ia) luminosity function (LF) using the Zwicky Transient Facility Bright Transient Survey (BTS) catalogue. While this magnitude-limited survey has an unprecedented number of objects, it suffers from large distance uncertainties and lacks an estimation of host extinction. We bypass these issues by calculating the intrinsic luminosities from the shape parameters of the light curve’s g and r bands, with the luminosities calibrated from the well observed SNe Ia sample of the Carnegie Supernova Project, allowing us to construct, for the first time, the intrinsic LF of SNe Ia. We then use a novel tight relation between the colour stretch and the synthesized 56Ni mass, MNi56, to determine the MNi56 distribution of SNe Ia. We find that the LFs are unimodal, with their peaks in line with previous results, but have a much lower rate of dim events and luminous events. We show that the features on top of the unimodal LF-derived distributions are all compatible with statistical noise, consistent with a single progenitor channel for the explosions. We further derive, for the first time, the SNe Ia distribution of host galaxy extinction, and find a mean selective extinction of E(B − V) ≈ 0.1 and a non-negligible fraction with large, $\gt 1\, \text{mag}$, extinction in the optical bands. The high extinction is typical for luminous SNe, supporting their young population origin.