bluuebunny/crossref_metadata_2025_split huggingface dataset:
When Does Stand-Alone Software Qualify as a Medical Device in the European Union?—The Cjeu’s Decision in Snitem and What it Implies for the Next Generation of Medical Devices
Authors: Minssen Timo , Mimler Marc , Mak Vivian 
Published: June 2020

Abstract
This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the ‘medical purpose’ categories of the regulatory definition of ‘medical device’. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data.
High circular polarization of near-infrared light induced by micron-sized dust grains
Authors: Fukushima Hajime , Yajima Hidenobu , Umemura Masayuki 
Published: June 2020

ABSTRACT
We explore the induction of circular polarization (CP) of near-infrared light in star-forming regions using three-dimensional radiative transfer calculations. The simulations trace the change of Stokes parameters at each scattering/absorption process in a dusty gas slab composed of aligned grains. We find that the CP degree enlarges significantly according as the size of dust grains increases and exceeds ∼20 per cent for micron-sized grains. Therefore, if micron-sized grains are dominant in a dusty gas slab, the high CP observed around luminous young stellar objects can be accounted for. The distributions of CP show the asymmetric quadrupole patterns regardless of the grain sizes. Also, we find that the CP degree depends on the relative position of a dusty gas slab. If a dusty gas slab is located behind a star-forming region, the CP reaches ∼60 per cent in the case of 1.0 µm dust grains. Hence, we suggest that the observed variety of CP maps can be explained by different size distributions of dust grains and the configuration of aligned grains.
Chaos and Lévy flights in the three-body problem
Authors: Manwadkar Viraj , Trani Alessandro A , Leigh Nathan W C 
Published: June 2020

ABSTRACT
We study chaos and Lévy flights in the general gravitational three-body problem. We introduce new metrics to characterize the time evolution and final lifetime distributions, namely Scramble Density $\mathcal {S}$ and the Lévy flight (LF) index $\mathcal {L}$, that are derived from the Agekyan–Anosova maps and homology radius $R_{\mathcal {H}}$. Based on these metrics, we develop detailed procedures to isolate the ergodic interactions and Lévy flight interactions. This enables us to study the three-body lifetime distribution in more detail by decomposing it into the individual distributions from the different kinds of interactions. We observe that ergodic interactions follow an exponential decay distribution similar to that of radioactive decay. Meanwhile, Lévy flight interactions follow a power-law distribution. Lévy flights in fact dominate the tail of the general three-body lifetime distribution, providing conclusive evidence for the speculated connection between power-law tails and Lévy flight interactions. We propose a new physically motivated model for the lifetime distribution of three-body systems and discuss how it can be used to extract information about the underlying ergodic and Lévy flight interactions. We discuss ejection probabilities in three-body systems in the ergodic limit and compare it to previous ergodic formalisms. We introduce a novel mechanism for a three-body relaxation process and discuss its relevance in general three-body systems.
Automation of the AST3 optical sky survey from Dome A, Antarctica
Authors: Ma Bin , Hu Yi , Shang Zhaohui , Hu Keliang , Wang Yongjiang , Yang Xu , Ashley Michael C B , Yuan Xiangyan , Wang Lifan 
Published: June 2020

ABSTRACT
The 0.5-m Antarctic Survey Telescopes (AST3) were designed for time-domain optical/infrared astronomy. They are located in Dome A, Antarctica, where they can take advantage of the continuous dark time during winter. Since the site is unattended in winter, everything for the operation, from observing to data reduction, had to be fully automated. Here, we present a brief overview of the AST3 project and some of its unique characteristics due to its location in Antarctica. We summarize the various components of the survey, including the customized hardware and software, that make complete automation possible.
The origin of X-ray emission in the gamma-ray emitting narrow-line Seyfert 1 1H 0323+342
Authors: Mundo Sergio A , Kara Erin , Cackett Edward M , Fabian A C , Jiang J , Mushotzky R F , Parker M L , Pinto C , Reynolds C S , Zoghbi A 
Published: June 2020

ABSTRACT
We present the results of X-ray spectral and timing analyses of the closest gamma-ray emitting narrow-line Seyfert 1 (γ-NLS1) galaxy, 1H 0323+342. We use observations from a recent, simultaneous XMM–Newton/NuSTAR campaign. As in radio-quiet NLS1s, the spectrum reveals a soft excess at low energies (≲2 keV) and reflection features such as a broad iron K emission line. We also find evidence of a hard excess at energies above ∼35 keV that is likely a consequence of jet emission. Our analysis shows that relativistic reflection is statistically required, and using a combination of models that includes the reflection model relxill for the broad-band spectrum, we find an inclination of $i=63^{+7}_{-5}$ degrees, which is in tension with much lower values inferred by superluminal motion in radio observations. We also find a flat (q = 2.2 ± 0.3) emissivity profile, implying that there is more reflected flux than usual being emitted from the outer regions of the disc, which in turn suggests a deviation from the thin disc model assumption. We discuss possible reasons for this, such as reflection off of a thick accretion disc geometry.
Enhanced secondary pollution offset reduction of primary emissions during COVID-19 lockdown in China
Authors: Huang Xin , Ding Aijun , Gao Jian , Zheng Bo , Zhou Derong , Qi Ximeng , Tang Rong , Wang Jiaping , Ren Chuanhua , Nie Wei , Chi Xuguang , Xu Zheng , Chen Liangduo , Li Yuanyuan , Che Fei , Pang Nini , Wang Haikun , Tong Dan , Qin Wei , Cheng Wei , Liu Weijing , Fu Qingyan , Liu Baoxian , Chai Fahe , Davis Steven J , Zhang Qiang , He Kebin 
Published: June 2020

AbstractTo control the spread of the 2019 novel coronavirus (COVID-19), China imposed nationwide restrictions on the movement of its population (lockdown) after the Chinese New Year of 2020, leading to large reductions in economic activities and associated emissions. Despite such large decreases in primary pollution, there were nonetheless several periods of heavy haze pollution in eastern China, raising questions about the well-established relationship between human activities and air quality. Here, using comprehensive measurements and modeling, we show that the haze during the COVID lockdown was driven by enhancements of secondary pollution. In particular, large decreases in NOx emissions from transportation increased ozone and nighttime NO3 radical formation, and these increases in atmospheric oxidizing capacity in turn facilitated the formation of secondary particulate matter. Our results, afforded by the tragic natural experiment of the COVID-19 pandemic, indicate that haze mitigation depends upon a coordinated and balanced strategy for controlling multiple pollutants.
Promoting Protesters’ Compliance: The Effect of General Perceptions of the Police versus Police Actions
Authors: Perry Gali 
Published: June 2020

Abstract
Public willingness to comply with the police is desirable in democratic societies, and even more so in high-risk policing tasks such as protest policing. To allow freedom of speech while maintaining public order, officers require protesters to follow orders and cooperate. The process-based model of policing suggests that protesters’ compliance will be mainly affected by their general perceptions of the police—primarily, trust in the police and perceptions of just policing procedures. In conjunction, police actions during a demonstration and the dynamics between officers and protesters can also affect protesters’ willingness to comply. This study uses a series of Ordinary Least Squares (OLS) regression models to analyse survey responses of 470 protesters who participated in the ‘Occupy’ protests in Israel during 2012. Findings suggest that positive evaluations of trust in the police and policing procedures correlate with compliance; however, when protesters perceived police actions as negative, they were less willing to comply.
Permutational analysis of Saccharomyces cerevisiae regulatory elements
Authors: Dhillon Namrita , Shelansky Robert , Townshend Brent , Jain Miten , Boeger Hinrich , Endy Drew , Kamakaka Rohinton 
Published: June 2020

Abstract
Gene expression in Saccharomyces cerevisiae is regulated at multiple levels. Genomic and epigenomic mapping of transcription factors and chromatin factors has led to the delineation of various modular regulatory elements—enhancers (upstream activating sequences), core promoters, 5′ untranslated regions (5′ UTRs) and transcription terminators/3′ untranslated regions (3′ UTRs). However, only a few of these elements have been tested in combinations with other elements and the functional interactions between the different modular regulatory elements remain under explored. We describe a simple and rapid approach to build a combinatorial library of regulatory elements and have used this library to study 26 different enhancers, core promoters, 5′ UTRs and transcription terminators/3′ UTRs to estimate the contribution of individual regulatory parts in gene expression. Our combinatorial analysis shows that while enhancers initiate gene expression, core promoters modulate the levels of enhancer-mediated expression and can positively or negatively affect expression from even the strongest enhancers. Principal component analysis (PCA) indicates that enhancer and promoter function can be explained by a single principal component while UTR function involves multiple functional components. The PCA also highlights outliers and suggest differences in mechanisms of regulation by individual elements. Our data also identify numerous regulatory cassettes composed of different individual regulatory elements that exhibit equivalent gene expression levels. These data thus provide a catalog of elements that could in future be used in the design of synthetic regulatory circuits.
Polyethylene Oxide Molecular Size Determines the Severity of Atypical Thrombotic Microangiopathy in a Guinea Pig Model of Acute Intravenous Exposure
Authors: Baek Jin Hyen , Shin Hye Kyung H , Koo Soo Min , Gao Yamei , Qu Haiou , Feng Xin , Xu Xiaoming , Pinto Julia , Katneni Upendra , Kimchi-Sarfaty Chava , Buehler Paul W 
Published: June 2020

AbstractIn 2017, Opana ER was voluntarily removed from the U.S. market based on concerns that its risks outweighed its therapeutic benefits. The data that supported this conclusion were based on postmarketing evaluation that demonstrated increased intravenous abuse associated outbreaks of HIV, hepatitis C, and uniquely, a thrombotic thrombocytopenic purpura (TTP)-like syndrome. In 2017, the cause was mechanistically linked to intravenous exposure of the high-molecular weight polyethylene oxide (PEO), an excipient component of the drug product. However, it was unknown how differing PEO preparations might alter this response in vivo. Knowing the likelihood of a PEO driven atypical thrombotic microangiopathy with hemolytic uremic syndrome (TMA-HUS), this study was specifically designed with the primary objective focused on understanding the impact of PEO molecular weight on TMA-HUS in a guinea pig model of acute repeat PEO (1, 4, and 7 MDa) dosing. Results from this analysis suggest that repeated dosing with PEO 4 and 7 MDa, but not 1 MDa induced a marked intravascular hemolysis with schistocytes, mild anemia, thrombocytopenia, hemoglobinuria, and kidney injury, consistent with observations of a TMA-HUS-like syndrome. Nonetheless, observations of tissue microthrombi, complement or altered von Willebrand factor involvement were not observed, which would be consistent with a definitive TMA. Further, only 7 MDa PEO dosing was associated with marked renal hypoxia. Taken together, this study defines renal injury risk with PEO formulations &gt;1 MDa that is driven by a robust intravascular hemolysis and potentially, tissue hypoxia.
The terminalia of the superfamily Scarabaeoidea (Coleoptera): specific glossary, dissecting methodology, techniques and previously unrecorded sexual dimorphism in some difficult groups
Authors: Cristóvão Joana P , Vaz-de-Mello Fernando Z 
Published: June 2020

AbstractThe terminology used for the morphological structures of the abdomen as well as male and female genitalia across the superfamily Scarabaeoidea is discussed, based on a literature review across the group. Issues relating to the orientation of the male terminalia and potential homologies between the ‘genital capsule’- and ‘spiculum gastrale’-bearing taxa are discussed and standardisation of terminology pertaining to some ambiguous terms is proposed. A Scarabaeoidea-specific glossary is presented, and synonyms across the literature are given. Schematic illustrations of the abdomen and terminalia are provided. Some new morphological structures are here described for the first time. A standardised dissection protocol for male and female Scarabaeoidea is proposed. Sexually dimorphic structures in the abdomen of Pleurosticti (Dynastinae, Rutelinae, Melolonthinae and Cetoniinae), Glaphyridae, Phaenomeridinae, Passalidae and Omorgus (Trogidae) are described and illustrated for the first time, providing future workers with the possibility to determine the sex of specimens based on external characters without the need for dissection.
Contamination in Urine Samples Collected Using Bladder Stimulation and Clean Catch Versus Urinary Catheterization in Infants Younger Than 90 Days
Authors: Rivas-García Arístides , Lorente-Romero Jorge , López-Blázquez María , Rodríguez-Jiménez Cristina , Castro-Rodríguez Cristina , Míguez-Navarro María Concepción 
Published: June 2020

Objectives
The objective of this study was to compare the risk of contamination for urine samples collected from patients younger than 90 days using 2 different techniques: bladder stimulation and “clean catch” (CC) and urinary catheterization (CATH).

Methods
A case-control study was carried out in the pediatric emergency room of a tertiary hospital between January 2016 and September 2017. All urine samples collected from patients younger than 90 days by CC or CATH were included. The incidence of contaminated urine samples was compared for both methods, and the risk of contamination was estimated using univariate and multivariate analyses.

Results
A total of 473 urine samples were collected, 310 via CATH (65.5%) and 163 via CC (34.5%). The median age was 1.4 months (interquartile range, 0.8–2.1 months), and 54.1% were males. Seventeen patients had a history of urinary tract infection (3.6%), and 16 were diagnosed with a congenital urorenal anomaly (3.4%). Sixteen urine samples were found to be contaminated (3.4%): 5 collected via CATH (1.6%) and 11 via CC (6.8%). The univariate analysis revealed a greater risk of contamination in specimens obtained using CC versus CATH (odds ratio, 4.41; 95% confidence interval, 1.51–12.93), and the multivariate analysis confirmed CC collection as an independent risk factor for contamination (odds ratio, 5.61; 95% confidence interval, 1.83–17.19).

Conclusions
The number of contaminated urine samples in infants younger than 90 days in our pediatric emergency department is low. However, using the CC urine collection technique seems to be an independent risk factor for sample contamination.
Low and high infection dose transmissions of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany
Authors: Pfefferle Susanne , Günther Thomas , Kobbe Robin , Czech-Sioli Manja , Nörz Dominic , Santer René , Oh Jun , Kluge Stefan , Oestereich Lisa , Peldschus Kersten , Indenbirken Daniela , Huang Jiabin , Grundhoff Adam , Aepfelbacher Martin , Knobloch Johannes K. , Lütgehetmann Marc , Fischer Nicole 
Published: June 2020

AbstractObjectivesWe used viral genomics to deeply analyze the first SARS-CoV-2 infection clusters in the metropolitan region of Hamburg, Germany. Epidemiological analysis and contact tracing together with a thorough investigation of virus variant patterns revealed low and high infection dose transmissions to be involved in transmission events.MethodsInfection control measures were applied to follow up contract tracing. Metagenomic RNA- and SARS-CoV-2 amplicon sequencing was performed from 25 clinical samples for sequence analysis and variant calling.ResultsThe index patient acquired SARS-CoV-2 in Italy and after his return to Hamburg transmitted it to 2 out of 132 contacts. Virus genomics and variant pattern clearly confirms the initial local cluster. We identify frequent single nucleotide polymorphisms at positions 241, 3037, 14408, 23403 and 28881 previously described in Italian sequences and now considered as one major genotype in Europe. While the index patient showed a single nucleotide polymorphism only one variant was transmitted to the recipients. Different to the initial cluster, we observed in household clusters occurring at the time in Hamburg also intra-host viral species transmission events.ConclusionsSARS-CoV-2 variant tracing highlights both, low infection dose transmissions suggestive of fomites as route of infection in the initial cluster and high and low infection dose transmissions in family clusters indicative of fomites and droplets as infection routes. This suggests (1) single viral particle infection can be sufficient to initiate SARS-CoV-2 infection and (2) household/family members are exposed to high virus loads and therefore have a high risk to acquire SARS-CoV-2.
CyTOF analysis identifies unusual immune cells in urine of BCG-treated bladder cancer patients
Authors: Castellano Eva , Samba Célia , Esteso Gloria , Simpson Laura , Vendrame Elena , García-Cuesta Eva M. , López-Cobo Sheila , Álvarez-Maestro Mario , Linares Ana , Leibar Asier , Ranganath Thanmayi , Reyburn Hugh T. , Martínez-Piñeiro Luis , Blish Catherine , Valés-Gómez Mar 
Published: June 2020

AbstractHigh grade non-muscle-invasive bladder tumours are treated with transurethral resection followed by recurrent intravesical instillations of Bacillus Calmette Guérin (BCG). Although bladder cancer patients respond well to BCG, important questions remain unanswered, including how to identify at early stages non-responder patients and patients at risk to abandon the treatment. Here, we analysed the cells released into the urine of bladder cancer patients longitudinally 3-7 days after BCG instillations. Mass cytometry (CyTOF) analyses revealed that most cells were granulocytes and monocytes rather than effector lymphocytes, and most expressed activation markers. A novel population of CD15+CD66b+CD14+CD16+cells was very abundant in several samples and expression of these markers was confirmed using flow cytometry and qPCR. Samples of patients with a stronger inflammatory response contained more cells in urine; however, this was not due to haematuria, as the proportions of the cell populations observed were different from blood. We provide the proof-of-concept for a new approach to analyse samples that may help classify patients and identify those at risk of BCG infection and other unwanted BCG-related events.
Evaluation of SARS-CoV-2 in Breastmilk from 18 Infected Women
Authors: Chambers Christina D. , Krogstad Paul , Bertrand Kerri , Contreras Deisy , Tobin Nicole H. , Bode Lars , Aldrovandi Grace M. 
Published: June 2020

To The EditorCurrently, the U.S. Centers for Disease Control and Prevention, American Academy of Pediatrics and the World Health Organization advise that women who are infected with SARS-CoV-2 may choose to breastfeed with appropriate protections to prevent transmission of the virus through respiratory droplets.(1) However, the potential for exposure to SARS-CoV-2 through breastfeeding is currently unknown. To date, case reports on breastmilk samples from a total of 24 SARS-CoV-2-infected women have been published.(2-7) Of those, viral RNA was detected in ten breastmilk samples from four women. In some but not all cases, environmental contamination as the source of the virus or retrograde flow from an infected infant could not be ruled out.
Light propagation within N95 Filtered Face Respirators: A simulation study for UVC decontamination
Authors: Lilge Lothar , Manalac Angelica , Weersink Madrigal , Schwiegelshohn Fynn , Young-Schultz Tanner , Abdalrhman Abdallatif Satti , Wang Chengjin , Ngan Aldrich , Gu Frank X. , Betz Vaughn , Hofmann Ron 
Published: June 2020

This study presents numerical simulations of UVC light propagation through seven different filtered face respirators (FFR) to determine their suitability for UV germicidal inactivation (UVGI). UV propagation was modelled using the FullMonte program for two external light illuminations. The optical properties of the dominant three layers were determined using the inverse adding doubling method.The resulting fluence rate volume histograms and the lowest fluence rate recorded in the modelled volume, sometimes in the nW cm-2, provide feedback on a respirator’s suitability for UVGI and the required exposure time for a given light source. While UVGI can present an economical approach to extend an FFR’s useable lifetime, it requires careful optimization of the illumination setup and selection of appropriate respirators.Abstract Figure
Study of pre-hospital care of Out of Hospital Cardiac Arrest victims and their outcome in a tertiary care hospital in India
Authors: Bhat Rachana , Ravindra Prithvishree , Sahu Ankit Kumar , Mathew Roshan , Wilson William 
Published: June 2020

AbstractBACKGROUNDIndia does not have a formal cardiac arrest registry and a centralized emergency medical system. In this study, we aimed to assess the prehospital care received by the patients with OHCA and to predict the factors that could influence their outcome.METHODSWe performed a prospective observational study, including OHCA patients presenting to the emergency department (ED) between February 2019 and January 2020. A structured proforma was used to capture information like basic demography, prehospital details like bystander cardiopulmonary resuscitation (CPR), use of an automated external defibrillator (AED), clinical profile, and outcome.RESULTSAmong the included 205 patients, the majority were male (71.2%) and belonged to older age (49.3%). The nature of arrest was predominantly non-traumatic (82.4%). The initial rhythm at presentation was non-shockable (96.5%). Return of spontaneous circulation (ROSC) was achieved in 17 (8.3%) patients, of which only 3 (1.4%) patients survived till discharge. The home was the most common location of OHCA (116, 56.6%). Among the OHCA patients, witnessed arrests were seen only in 64 (31.2%), of which 15 (7.8%) received bystander CPR, and AED was used in 1% of the patients. The initial shockable rhythm was a significant predictor of ROSC (OR 18.97 95%CI 3.83-93.89; p<0.001) and survival to discharge (OR 42.67; 95%CI 7.69-234.32; p<0.001).CONCLUSIONIn a developing country like India, this study underlines the poor status of the prehospital system like lower bystander CPR, AED and ambulance usage. Moreover, ROSC was seen only in less than 10% of patients, and only 1.3% got discharged from the hospital.