bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessing the legal duty to use or disclose interim data for ongoing clinical trials
Authors: Eckstein Lisa 
Published: June 2019

Abstract
Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information.
This paper canvasses potential legal obligations to use or disclose emerging clinical trial data, including through tort law and securities laws. The analysis is supplemented by a comprehensive search of US cases in which courts have adjudicated upon such allegations. Notably, available cases demonstrate widespread judicial deference to clinical trial practices designed to shield clinical trial actors from emerging information. As a result, despite a theoretical possibility of legal obligations of use or disclosure, it appears that these will rarely be enforceable.
On the satisfiability problem for fragments of two-variable logic with one transitive relation
Authors: Szwast Wiesław , Tendera Lidia 
Published: June 2019

Abstract
We study the satisfiability problem for two-variable first-order logic over structures with one transitive relation. We show that the problem is decidable in 2-NExpTime for the fragment consisting of formulas where existential quantifiers are guarded by transitive atoms. As this fragment enjoys neither the finite model property nor the tree model property, to show decidability we introduce a novel model construction technique based on the infinite Ramsey theorem.
We also point out why the technique is not sufficient to obtain decidability for the full two-variable logic with one transitive relation; hence, contrary to our previous claim, [FO$^2$ with one transitive relation is decidable, STACS 2013: 317-328], the status of the latter problem remains open.
PAS stain based histological classification and severity grading of toenail onychomycosis
Authors: Hao Xingpei , Yim Joon , Freedman David , Siddiqui Sarwat , Levine David , Tritto Michael , Saffo Gina M , Isaac Adam , Mirkin Gene 
Published: June 2019

Abstract
Onychomycosis is a common world-wide health issue. Accurate detection is essential for treatment. Multiple studies have shown that PAS-stain based histological visualization of fungal elements is superior to either direct microscopy with 20% potassium hydroxide, or fungal culture. However, PAS stain based histological classification and severity grading of onychomycosis are lacking in the literature. Here we reported a fungal detection rate of 47.87% based on an analysis of 13,805 toenails processed for H&E and PAS stains over a three year period. Based on the analysis of fungal density, distribution and infiltrating depth level in 858 PAS-positive toenails, we created a novel PAS stain based histological classification system to classify onychomycosis as occult onychomycosis (OO), focal or diffuse subungual onychomycosis (FSO or DSO), focal or diffuse plate onychomycosis (FPO or DPO), focal or diffuse subungual and plate onychomycosis (FSPO or DSPO) and superficial onychomycosis (SO). The severities of OO, FSO and FPO were graded as mild, DSO and DPO as moderate, FSPO and DSPO as severe infections, which revealed that more than 75% PAS positive toenails were severe infections. Evaluation of 97 paired toenails biopsied pre- and post-treatment from 47 patients demonstrated that the severity of infection was significantly reduced from severe to mild and moderate levels. These data indicate that the current histological classification evaluates not only the severity of the fungal infection but also the response to treatment. We further propose a guideline for treatment of onychomycosis based on the histological classification and severity.
Testing the weak equivalence principle by differential measurements of fundamental constants in the Magellanic Clouds
Authors: Levshakov S A , Ng K-W , Henkel C , Mookerjea B , Agafonova I I , Liu S-Y , Wang W-H 
Published: June 2019

ABSTRACT
Non-standard fields are assumed to be responsible for phenomena attributed to dark energy and dark matter. Being coupled to ordinary matter, these fields modify the masses and/or charges of the elementary particles, thereby violating the weak equivalence principle. Thus, values of fundamental constants such as the proton-to-electron mass ratio, μ, and/or the fine structure constant, α, measured in different environment conditions can be used as probes for this coupling. Here we perform differential measurements of F = μα2 to test a non-standard coupling in the Magellanic Clouds–dwarf galaxies where the overall mass budget is dominated by dark matter. The analysis is based on [C i] and CO lines observed with the Herschel Space Observatory. Since these lines have different sensitivities to changes in μ and α, the combined α and μ variations can be evaluated through the radial velocity offsets, ΔV, between the CO and [C i] lines. Averaging over nine positions in the Magellanic Clouds, we obtain 〈ΔV〉 = −0.02 ± 0.07 km s−1, leading to |ΔF/F| < 2 × 10−7 (1σ), where ΔF/F = (Fobs − Flab)/Flab. However, for one position observed with five times higher spectral resolution we find ΔV = −0.05 ± 0.02 km s−1, resulting in ΔF/F = (−1.7 ± 0.7) × 10−7. Whether this offset is due to changes in the fundamental constants, due to chemical segregation in the emitting gas, or merely due to Doppler noise requires further investigations.
Fast-rising blue optical transients and AT2018cow following electron-capture collapse of merged white dwarfs
Authors: Lyutikov Maxim , Toonen Silvia 
Published: June 2019

AbstractWe suggest that fast-rising blue optical transients (FBOTs) and the brightest event of the class, AT2018cow, result from an electron-capture collapse to a neutron star following the merger of a massive ONeMg white dwarf (WD) with another WD. Two distinct evolutionary channels lead to the disruption of the less-massive WD during the merger and the formation of a shell-burning non-degenerate star incorporating the ONeMg core. During the shell-burning stage, a large fraction of the envelope is lost to the wind, while mass and angular momentum are added to the core. As a result, the electron-capture collapse occurs with a small envelope mass, after ∼102–104 yr. During the formation of a neutron star, as little as ${\sim } 10^{-2} \, \mathrm{M}_\odot$ of the material is ejected at the bounce-off with mildly relativistic velocities and total energy of about a few 1050 erg. This ejecta becomes optically thin on a time-scale of days – this is the FBOT. During the collapse, the neutron star is spun up and the magnetic field is amplified. The ensuing fast magnetically dominated relativistic wind from the newly formed neutron star shocks against the ejecta, and later against the wind. The radiation-dominated forward shock produces the long-lasting optical afterglow, while the termination shock of the relativistic wind produces the high-energy emission in a manner similar to pulsar wind nebulae. If the secondary WD was of the DA type, the wind will likely have ${\sim } 10^{-4} \, \mathrm{M}_\odot$ of hydrogen; this explains the appearance of hydrogen late in the afterglow spectrum. The model explains many of the puzzling properties of FBOTs/AT2018cow: host galaxies, a fast and light anisotropic ejecta producing a bright optical peak, afterglow high-energy emission of similar luminosity to the optical, and late infrared features.
Dust in and around galaxies: dust in cluster environments and its impact on gas cooling
Authors: Vogelsberger Mark , McKinnon Ryan , O’Neil Stephanie , Marinacci Federico , Torrey Paul , Kannan Rahul 
Published: June 2019

Abstract
Simulating the dust content of galaxies and their surrounding gas is challenging due to the wide range of physical processes affecting the dust evolution. Here we present cosmological hydrodynamical simulations of a cluster of galaxies, $M_\text{200,crit}=6 \times 10^{14}{\, \rm M_\odot }$, including a novel dust model for the moving mesh code arepo. This model includes dust production, growth, supernova-shock-driven destruction, ion-collision-driven thermal sputtering, and high-temperature dust cooling through far-infrared reradiation of collisionally deposited electron energies. Adopting a rather low thermal sputtering rate, we find, consistent with observations, a present-day overall dust-to-gas ratio of ∼2 × 10−5, a total dust mass of ${\sim } 2\times 10^9{\, \rm M_\odot }$, and a dust mass fraction of ∼3 × 10−6. The typical thermal sputtering time-scales within ${\sim } 100\, {\rm kpc}$ are around ${\sim } 10\, {\rm Myr}$, and increase towards the outer parts of the cluster to ${\sim } 10^3\, {\rm Myr}$ at a cluster-centric distance of $1\, {\rm Mpc}$. The condensation of gas-phase metals into dust grains reduces high-temperature metal-line cooling, but also leads to additional dust infrared cooling. The additional infrared cooling changes the overall cooling rate in the outer parts of the cluster, beyond ${\sim } 1\, {\rm Mpc}$, by factors of a few. This results in noticeable changes of the entropy, temperature, and density profiles of cluster gas once dust formation is included. The emitted dust infrared emission due to dust cooling is consistent with observational constraints.
Structural insights into dimethylation of 12S rRNA by TFB1M: indispensable role in translation of mitochondrial genes and mitochondrial function
Authors: Liu Xiaodan , Shen Shengqi , Wu Pengzhi , Li Fudong , Liu Xing , Wang Chongyuan , Gong Qingguo , Wu Jihui , Yao Xuebiao , Zhang Huafeng , Shi Yunyu 
Published: June 2019

AbstractMitochondria are essential molecular machinery for the maintenance of cellular energy supply by the oxidative phosphorylation system (OXPHOS). Mitochondrial transcription factor B1 (TFB1M) is a dimethyltransferase that maintains mitochondrial homeostasis by catalyzing dimethylation of two adjacent adenines located in helix45 (h45) of 12S rRNA. This m62A modification is indispensable for the assembly and maturation of human mitochondrial ribosomes. However, both the mechanism of TFB1M catalysis and the precise function of TFB1M in mitochondrial homeostasis are unknown. Here we report the crystal structures of a ternary complex of human (hs) TFB1M–h45–S-adenosyl-methionine and a binary complex hsTFB1M–h45. The structures revealed a distinct mode of hsTFB1M interaction with its rRNA substrate and with the initial enzymatic state involved in m62A modification. The suppression of hsTFB1M protein level or the overexpression of inactive hsTFB1M mutants resulted in decreased ATP production and reduced expression of components of the mitochondrial OXPHOS without affecting transcription of the corresponding genes and their localization to the mitochondria. Therefore, hsTFB1M regulated the translation of mitochondrial genes rather than their transcription via m62A modification in h45.
Automatic assessment of glioma burden: a deep learning algorithm for fully automated volumetric and bidimensional measurement
Authors: Chang Ken , Beers Andrew L , Bai Harrison X , Brown James M , Ly K Ina , Li Xuejun , Senders Joeky T , Kavouridis Vasileios K , Boaro Alessandro , Su Chang , Bi Wenya Linda , Rapalino Otto , Liao Weihua , Shen Qin , Zhou Hao , Xiao Bo , Wang Yinyan , Zhang Paul J , Pinho Marco C , Wen Patrick Y , Batchelor Tracy T , Boxerman Jerrold L , Arnaout Omar , Rosen Bruce R , Gerstner Elizabeth R , Yang Li , Huang Raymond Y , Kalpathy-Cramer Jayashree 
Published: June 2019

Abstract

Background
Longitudinal measurement of glioma burden with MRI is the basis for treatment response assessment. In this study, we developed a deep learning algorithm that automatically segments abnormal fluid attenuated inversion recovery (FLAIR) hyperintensity and contrast-enhancing tumor, quantitating tumor volumes as well as the product of maximum bidimensional diameters according to the Response Assessment in Neuro-Oncology (RANO) criteria (AutoRANO).

Methods
Two cohorts of patients were used for this study. One consisted of 843 preoperative MRIs from 843 patients with low- or high-grade gliomas from 4 institutions and the second consisted of 713 longitudinal postoperative MRI visits from 54 patients with newly diagnosed glioblastomas (each with 2 pretreatment “baseline” MRIs) from 1 institution.

Results
The automatically generated FLAIR hyperintensity volume, contrast-enhancing tumor volume, and AutoRANO were highly repeatable for the double-baseline visits, with an intraclass correlation coefficient (ICC) of 0.986, 0.991, and 0.977, respectively, on the cohort of postoperative GBM patients. Furthermore, there was high agreement between manually and automatically measured tumor volumes, with ICC values of 0.915, 0.924, and 0.965 for preoperative FLAIR hyperintensity, postoperative FLAIR hyperintensity, and postoperative contrast-enhancing tumor volumes, respectively. Lastly, the ICCs for comparing manually and automatically derived longitudinal changes in tumor burden were 0.917, 0.966, and 0.850 for FLAIR hyperintensity volume, contrast-enhancing tumor volume, and RANO measures, respectively.

Conclusions
Our automated algorithm demonstrates potential utility for evaluating tumor burden in complex posttreatment settings, although further validation in multicenter clinical trials will be needed prior to widespread implementation.
Transfusion-Transmitted Malaria: A Systematic Review and Meta-analysis
Authors: Ahmadpour Ehsan , Foroutan-Rad Masoud , Majidiani Hamidreza , Moghaddam Sirous Mehrani , Hatam-Nahavandi Kareem , Hosseini Seyed-Abdollah , Rahimi Mohammad Taghi , Barac Aleksandra , Rubino Salvatore , Zarean Mehdi , Mathioudakis Alexander G , Cevik Muge 
Published: June 2019

Abstract

Background
Malaria transmission through blood transfusion is an accidental but preventable cause of malaria infection and is increasingly becoming a matter of concern for blood transfusion services. This systematic review was conducted to provide a summary of evidence about the prevalence of Plasmodium infection in asymptomatic blood donors and the effectiveness of screening methods used based on the available literature.

Methods
PRISMA guidelines were followed. Scopus, PubMed, Science Direct, and EMBASE were searched from 1982 to October 10, 2017. All peer-reviewed original research articles describing the prevalence of malaria parasitemia in blood donors with different diagnostic methods were included. The random-effects model was applied to assess the effects of heterogeneity among the selected studies. Incoherence and heterogeneity between studies were quantified by I2 index and Cochran’s Q test. Publication and population bias was assessed with funnel plots and Egger’s regression asymmetry test. All statistical analyses were performed using Stata (version 2.7.2).

Results
Seventy-one studies from 21 countries, 5 continents, were included in the present systematic review. The median prevalence of malaria parasitemia among 984 975 asymptomatic healthy blood donors was 10.54%, 5.36%, and 0.38% by microscopy, molecular methods (polymerase chain reaction), and rapid diagnostic tests, respectively. The most commonly detected Plasmodium species was P. falciparum.

Conclusions
This systematic review demonstrates that compared with other transfusion-linked infections, that is, HIV, HCV, and HBV, transfusion-transmitted malaria is one of the most significant transfusion-associated infections especially in Sub-Saharan Africa. Future work must aim to understand the clinical significance of transfusion-transmitted malaria in malaria-endemic settings.
Alternative organizing with social purpose: revisiting institutional analysis of market-based activity
Authors: Mair Johanna , Rathert Nikolas 
Published: June 2019

AbstractGiven rampant economic inequality, social exclusion and overconsumption, organizing in markets increasingly focuses on leveraging commercial activity for a social purpose. Alternative forms of organizing have developed to overcome the deficiencies of contemporary capitalism. They have become prevalent in numerous institutional contexts through types of organizations such as social enterprises, cooperatives and platform-based sharing economy organizations. Our objective is to ignite research on alternative organizing. We build on two important institutional perspectives, Neo-institutionalism and Comparative Capitalism, to investigate how these organizations diverge from the archetypal corporation. In addition, we develop a framework to guide institutional analysis of the origins, enabling conditions and consequences of alternative organizing in contemporary markets and society. We conclude by laying out pathways for future research.
‘The Annexed Photos were Taken Today’:1 Photographing Patients in the Late-Nineteenth-century Asylum
Authors: Rawling Katherine D B 
Published: June 2019

Summary
Photographing patients was a common practice in many asylums in the nineteenth century. Asylum casebooks contain thousands of patient photographs varying in style and content, but they have been paid relatively little attention by historians of medicine. When patient photographs have been considered, one type of photograph has been taken to represent all patient photography. Through a comparison of casebook photographs from two very different institutions, this article argues that photographic practices were fluid, ambiguous and diverse in the nineteenth century, and the camera was used in a variety of ways inside the asylum. Examining the visual patient record can enhance and even challenge established histories of mental illness and medico-psychiatric practices, as we consider the photographing of patients as a stage in the doctor–patient encounter, an important part of diagnosis and resulting treatment, and as a feature of patient experience.
Making a diagnosis in severe cutaneous drug hypersensitivity reactions
Authors: Ardern-Jones Michael R. , Mockenhaupt Maja 
Published: June 2019

Purpose of review
Severe cutaneous adverse reactions (SCAR) are relatively uncommon but can be life-threatening. This review focuses on the nonanaphylactic (non-IgE-mediated) phenotypes of drug hypersensitivity, with specific reference to diagnosis and management of acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens–Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).

Recent findings
Here, we review recent guidelines on optimal supportive care as well as publications of interventional treatment for SJS/TEN, including various immunomodulating therapies, and management strategies for severe ocular disease with the use of amniotic membrane transplantation. In DRESS, long-term autoimmune sequelae are increasingly recognized and modify strategies for treatment of the acute episode. If the causative drug is not apparent from careful inspection of the drug exposure history, in-vitro diagnostics, HLA testing and skin testing before drug challenge testing may be considered and we present an algorithm for investigation of complex cases.

Summary
Careful phenotypic analysis of the increasingly complex recognized patterns of SCAR facilitates the enhancement in our understanding of T-cell mediated drug hypersensitivity and allows the improvement of in-vitro diagnostic testing to minimize patient exposure to test substances in all but a very limited number of cases, thereby enhancing safety.
Diabetic Control Predicts Surgical Site Infection Risk in Orthopaedic Trauma Patients
Authors: Reich Michael S. , Fernandez Isaac , Mishra Abhinav , Kafchinski Lisa , Adler Adam , Nguyen Mai P. 
Published: June 2019

Objectives:
(1) To determine the incidence of surgical site infections (SSIs) in diabetic orthopaedic trauma patients and (2) to establish a protocol for managing diabetes mellitus (DM) in orthopaedic trauma patients.

Design:
Retrospective cohort study.

Setting:
Level 1 Trauma Center.

Patients:
All diabetic orthopaedic trauma patients who underwent surgical intervention with at least 1 month follow-up. Patients were classified as poorly controlled or controlled diabetic patients based on admission hemoglobin A1c and blood glucose (BG) levels.

Interventions:
Orthopaedic surgical intervention in accordance with fracture type and a standardized diabetes management protocol with internal medicine comanagement.

Main Outcome Measurement:
SSI incidence.

Results:
There were 260 patients during the study period. Two hundred two (77.7%) were included in the final analysis. Seventy-five (37.1%) patients met the criteria for poorly controlled DM. The overall rate of SSI was 20.8%; 32.0% for poorly controlled diabetic patients, and 14.2% for controlled diabetic patients (P < 0.01). The admission blood glucose level (BG, P = 0.05), but not discharge BG, was associated with SSI incidence.

Conclusions:
Trauma patients with poorly controlled DM have a higher rate of SSIs than patients with controlled DM. Perioperative diabetes control does not seem to decrease infection rates in these patients.

Level of Evidence:
Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Trabecular bone score of postmenopausal women is positively correlated with bone mineral density and negatively correlated with age and body mass index
Authors: Torgutalp Şerife Ş. , Babayeva Naila , Kara Ömer S. , Özkan Ömer , Dönmez Gürhan , Korkusuz Feza 
Published: June 2019

Abstract

Objective:
Trabecular bone score (TBS), an indirect evaluation of skeletal microarchitecture, is calculated from dual-energy X-ray absorptiometry (DXA). This study aimed to determine the mean TBS values in healthy postmenopausal women and overall association between TBS and demographic features, bone mineral density (BMD) of the lumbar spine and femoral neck, and BMD to body mass index (BMI) ratio of the lumbar spine.

Methods:
Fifty-three postmenopausal healthy women were enrolled. The BMD of the lumbar spine and femoral neck was measured by DXA. Anteroposterior lumbar spine acquisitions were used to calculate the TBS for L1 to L4.

Results:
The mean BMD of the lumbar spine and femoral neck was 0.945 ± 0.133 and 0.785 ± 0.112 g/cm2, respectively. The mean TBS was 1.354 ± 0.107. There was a significant positive moderate correlation between TBS and total lumbar BMD to BMI ratio (r = 0.595, P < 0.001), and significant positive weak correlations between TBS and BMD of the lumbar spine (r = 0.347, P = 0.011) as well as between TBS and femoral neck (r = 0.305, P = 0.026), whereas significant negative moderate correlations were observed between TBS and age (r = −0.393, P = 0.004) as well as between TBS and BMI (r = −0.333, P = 0.015).

Conclusions:
TBS values of postmenopausal women were negatively correlated with age and BMI, and positively with BMD and BMD to BMI ratio.