bluuebunny/crossref_metadata_2025_split huggingface dataset:
Understanding regulatory cultures: The case of water regulatory reforms in India
Authors: Srivastava Shilpi 
Published: May 2021

AbstractThis article uses the concept of regulatory cultures to understand the (dis)embedding of “independent” water regulation in India. It analyzes the specific case of the Maharashtra Water Resources Regulatory Authority and explores how discourses and practices (1990–2015) shaped the regulatory development in the water sector. By documenting the practices of meaning‐making of “independent” regulation, the paper queries the process(es) of subnational regulatory diffusion and analyzes how water regulation is translated, negotiated, contested, and subverted as situated meanings evolve in the process. Taking an anthropological approach to studying the State and regulation, the article demonstrates how and why the State remains at the very center of the regulatory project in the water sector in India.
Child labor, social capital, and economic development*
Authors: Mizushima Atsue 
Published: May 2021

AbstractGlobally, 152 million children are involved in economic activities. Poverty is the main cause of child labor, and the lack of social norms and inadequate legal systems are contributing factors. In order to understand the cause of child labor and provide appropriate assistance, this paper focuses on the accumulation of human capital and social capital. The first part of the paper shows that, historically, child labor has been highly dependent on the initial endowments of human capital and social capital. We also show that the condition of bifurcation from an identical initial condition depends on the productivity derived from social capital. The second part of the paper examines the effect of development aid in recipient countries, particularly the effect of two types of programs that attempt to eliminate child labor and provide support to strengthen social capital. We show that both programs are effective at making the economy better off. However, large amounts of development aid for the program that strengthens social capital can make the economy of middle‐income countries worse off.
Are We Forgetting About IgA? A Re‐examination of Coronavirus Disease 2019 Convalescent Plasma
Authors: Verkerke Hans , Saeedi Bejan J. , Boyer Darra , Allen Jerry W. , Owens Joshua , Shin Sooncheon , Horwath Michael , Patel Kashyap , Paul Anu , Wu Shang‐Chuen , Wang Jianmei , Ho Alex , Maier Cheryl L. , Zerra Patricia E. , Chonat Satheesh , Arthur Connie M. , Roback John D. , Neish Andrew S. , Lough Christopher , Josephson Cassandra D. , Stowell Sean R. 
Published: May 2021

AbstractBackgroundWhile convalescent plasma (CP) may benefit patients with COVID‐19, fundamental questions remain regarding its efficacy, including the components of CP that may contribute to its therapeutic effect. Most current serological evaluation of CP relies on examination of total immunoglobulin or IgG‐specific anti‐SARS‐CoV‐2 antibody levels. However, IgA antibodies, which also circulate and are secreted along the respiratory mucosa, represent a relatively uncharacterized component of CP.Study design and methodsResidual samples from patients and CP donors were assessed for IgM, IgG, and IgA anti‐SARS‐CoV‐2 antibody titers against the receptor‐binding domain responsible for viral entry. Symptom onset was obtained by chart review.ResultsIncreased IgA anti‐SARS‐CoV‐2 antibody levels correlated with clinical improvement and viral clearance in an infant with COVID‐19, prompting a broader examination of IgA levels among CP donors and hospitalized patients. Significant heterogeneity in IgA levels was observed among CP donors, which correlated weakly with IgG levels or the results of a commonly employed serological test. Unlike IgG and IgM, IgA levels were also more likely to be variable in hospitalized patients and this variability persisted in some patients >14 days following symptom onset. IgA levels were also less likely to be sustained than IgG levels following subsequent CP donation.ConclusionsIgA levels can be very heterogenous among CP donors and hospitalized patients and do not necessarily correlate with commonly employed testing platforms. Examining isotype levels in CP and COVID‐19 patients may allow for a tailored approach when seeking to fill specific gaps in humoral immunity.
AWARENESS OF PAPAL STATEMENTS AND EVOLUTION ACCEPTANCE AMONG BRAZILIAN CATHOLIC SEMINARIANS
Authors: Campos Marcio Antonio 
Published: May 2021

AbstractThe current generation of Catholic seminarians is among the first ones to be trained to priesthood in a fully digital age, with unlimited access to sources for news, research, and controversies about science and religion, including the one opposing creationism and Darwinian evolution, despite favorable statements on evolution by twentieth and twenty‐first century Popes. This article presents an online survey conducted in 2019 among 229 Brazilian seminarians; 48 percent of them espoused evolutionary views (below the average of Brazilians, and Brazilian Catholics, polled in 2010 and 2014), while 55.9 percent considered evolution partially or fully compatible with Catholicism. Favorable views on evolution were more frequent among seminarians with a higher knowledge of the theory, and among those aware of papal statements on the subject, although it is not certain whether such awareness is the reason for a higher acceptance of evolution. Establishing relations of causation, which requires further research, can give evolution advocates a valuable tool to improve its acceptance among Catholics.
A Method to Compare Heterogeneous Types of Bone and Cartilage Meshes
Authors: Rooks Nynke B. , Schneider Marco T. Y. , Erdemir Ahmet , Halloran Jason P. , Laz Peter J. , Shelburne Kevin B. , Hume Donald R. , Imhauser Carl W. , Zaylor William , Elmasry Shady , Schwartz Ariel , Chokhandre Snehal K. , Abdollahi Nohouji Neda , Besier Thor F. 
Published: May 2021

Abstract
Accurately capturing the bone and cartilage morphology and generating a mesh remains a critical step in the workflow of computational knee joint modeling. Currently, there is no standardized method to compare meshes of different element types and nodal densities, making comparisons across research teams a significant challenge. The aim of this paper is to describe a method to quantify differences in knee joint bone and cartilages meshes, independent of bone and cartilage mesh topology. Bone mesh-to-mesh distances, subchondral bone boundaries, and cartilage thicknesses from meshes of any type of mesh are obtained using a series of steps involving registration, resampling, and radial basis function fitting after which the comparisons are performed. Subchondral bone boundaries and cartilage thicknesses are calculated and visualized in a common frame of reference for comparison. The established method is applied to models developed by five modeling teams. Our approach to obtain bone mesh-to-mesh distances decreased the divergence seen in selecting a reference mesh (i.e., comparing mesh A-to-B versus mesh B-to-A). In general, the bone morphology was similar across teams. The cartilage thicknesses for all models were calculated and the mean absolute cartilage thickness difference was presented, the articulating areas had the best agreement across teams. The teams showed disagreement on the subchondral bone boundaries. The method presented in this paper allows for objective comparisons of bone and cartilage geometry that is agnostic to mesh type and nodal density.
Investigation on the Characteristics of a New Structure Brake Distribution Valve
Authors: Wang Yu-qi , Liu Xin-hui , Chen Jin-shi , Han Ya-fang 
Published: May 2021

Abstract
A brake distribution valve is an important part of aircraft hydraulic systems. To realize the integration and lightweight design of traditional structure valves, boost the response speed of valves, and reduce the influence of nonwork zone and damping on valve performance, this paper presents a new structure brake distribution valve which consists of pressure reducing unit, overflow unit, and embedded shuttle valve instead of the traditional valve structure. Numerical simulations and model verification experiments of the entire valve demonstrate that the new structure valve's dynamic performance has been significantly improved on the premise of ensuring linear characteristics. The simulation results show that the response time of the new structure valve is shorter than that of the traditional structure valve, with a rate of 30.77%, in case of step response simulations, and the tracking error of the valve reduces by nearly 5% in sinusoidal response simulations.
New-onset type 1 diabetes in Finnish children during the COVID-19 pandemic
Authors: Salmi Heli , Heinonen Santtu , Hästbacka Johanna , Lääperi Mitja , Rautiainen Paula , Miettinen Päivi J , Vapalahti Olli , Hepojoki Jussi , Knip Mikael 
Published: May 2021

BackgroundViral infections may trigger type 1 diabetes (T1D), and recent reports suggest an increased incidence of paediatric T1D and/or diabetic ketoacidosis (DKA) during the COVID-19 pandemic.ObjectiveTo study whether the number of children admitted to the paediatric intensive care unit (PICU) for DKA due to new-onset T1D increased during the COVID-19 pandemic, and whether SARS-CoV-2 infection plays a role.MethodsThis retrospective cohort study comprises two datasets: (1) children admitted to PICU due to new-onset T1D and (2) children diagnosed with new-onset T1D and registered to the Finnish Pediatric Diabetes Registry in the Helsinki University Hospital from 1 April to 31 October in 2016–2020. We compared the incidence, number and characteristics of children with newly diagnosed T1D between the prepandemic and pandemic periods.ResultsThe number of children admitted to PICU due to new-onset T1D increased from an average of 6.25 admissions in 2016–2019 to 20 admissions in 2020 (incidence rate ratio [IRR] 3.24 [95% CI 1.80 to 5.83]; p=0.0001). On average, 57.75 children were registered to the FPDR in 2016–2019, as compared with 84 in 2020 (IRR 1.45; 95% CI 1.13 to 1.86; p=0.004). 33 of the children diagnosed in 2020 were analysed for SARS-CoV-2 antibodies, and all were negative.ConclusionsMore children with T1D had severe DKA at diagnosis during the pandemic. This was not a consequence of SARS-CoV-2 infection. Instead, it probably stems from delays in diagnosis following changes in parental behaviour and healthcare accessibility.
Understanding overuse of diagnostic imaging for patients with low back pain in the Emergency Department: a qualitative study
Authors: Blokzijl Johan , Dodd Rachael H , Copp Tessa , Sharma Sweekriti , Tcharkhedian Elise , Klinner Christiane , Maher Chris G , Traeger Adrian C 
Published: May 2021

BackgroundOveruse of lumbar imaging in the Emergency Department is a well-recognised healthcare challenge. Studies to date have not provided robust evidence that available interventions can reduce overuse. For an intervention aimed at reducing imaging to be effective, insight into how both patients and clinicians view lumbar imaging tests is essential.AimTo explore factors that might influence overuse of lumbar imaging in the Emergency Department.MethodsParticipants were recruited from three hospitals in Sydney, Australia between April and August 2019. We conducted focus groups and/or interviews with 14 patients and 12 clinicians. Sessions were audio-recorded and transcribed verbatim. Data were analysed using framework analysis by a team of four researchers with diverse backgrounds.ResultsPatients described feeling that the decision about lumbar imaging was made by their Emergency Department clinician and reported little involvement in the decision-making process. Other potential drivers of lumbar imaging overuse from the patients’ perspective were strong expectations for lumbar imaging, a reluctance to delay receiving a diagnosis, and requirements from third parties (eg, insurance companies) to have imaging. Emergency Department clinicians suggested that the absence of an ongoing therapeutic relationship, and the inability to manage perceived patient pressure could drive overuse of lumbar imaging. Suggested protective factors included: involving patients in the decision, ensuring clinicians have the ability to explain the reasons to avoid imaging and collaborative approaches to care both within the Emergency Department and with primary care.Conclusion and key findingsWe found several factors that could contribute to overuse of lumbar imaging in the Emergency Department. Solutions to overuse of lumbar imaging in the Emergency Department could include: (1) strategies to involve patients in decisions about imaging; (2) training and support to provide thorough and well explained clinical assessment for low back pain; and (3) systems that support collaborative approaches to care.
Gender differences in use of invasive diagnostic and therapeutic procedures for acute ischaemic heart disease in Chinese adults
Authors: Levy Muriel , Chen Yiping , Clarke Robert , Guo Yu , Lv Jun , Yu Canqing , Li Liming , Chen Zhengming , Mihaylova Borislava 
Published: May 2021

ObjectiveTo investigate gender differences in the use of diagnostic and therapeutic procedures for acute ischaemic heart disease (IHD) in Chinese adults and assess whether socioeconomic or health system factors contribute to such differences.MethodsIn 2004–2008, the China Kadoorie Biobank recruited 512 726 adults from 10 diverse areas in China. Data for 38 928 first hospitalisations with IHD (2911 acute myocardial infarction (AMI), 9817 angina and 26 200 other IHD) were obtained by electronic linkage to health insurance records until 31 December 2016. Multivariate Poisson regression models were used to estimate women-to-men rate ratios (RRs) of having cardiac enzyme tests, coronary angiography and coronary revascularisation.ResultsAmong the 38 928 individuals (61% women) with IHD admissions, women were less likely to have AMI (5% vs 12%), but more likely to have angina (26% vs 24%) or other IHD (69% vs 64%). For admissions with AMI, there were no differences in the use of cardiac enzymes between women and men (RR=1.00; 95% CI, 0.97 to 1.03), but women had lower use of coronary angiography (0.80, 0.68 to 0.93) and coronary revascularisation (0.85, 0.74 to 0.99). For angina, the corresponding RRs were: 0.97 (0.94 to 1.00), 0.66 (0.59 to 0.74) and 0.56 (0.47 to 0.67), respectively; while for other IHD, they were 0.97 (0.94 to 1.00), 0.87 (0.76 to 0.99) and 0.61 (0.51 to 0.73), respectively. Adjusting for socioeconomic and health system factors did not significantly alter the women-to-men RRs.ConclusionsAmong Chinese adults hospitalised with acute IHD, women were less likely than men to have coronary angiography and revascularisation, but socioeconomic and health system factors did not contribute to these differences.
Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure
Authors: Burmester Gerd R , Nash Peter , Sands Bruce E , Papp Kim , Stockert Lori , Jones Thomas V , Tan Huaming , Madsen Ann , Valdez Hernan , Cohen Stanley B 
Published: May 2021

ObjectivesTo analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.MethodsThe analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.Results13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts.ConclusionsThe tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.
First-in-Human, Phase 1 Dose-Escalation Study of Biparatopic Anti-HER2 Antibody–Drug Conjugate MEDI4276 in Patients with HER2-positive Advanced Breast or Gastric Cancer
Authors: Pegram Mark D. , Hamilton Erika P. , Tan Antoinette R. , Storniolo Anna Maria , Balic Kemal , Rosenbaum Anton I. , Liang Meina , He Peng , Marshall Shannon , Scheuber Anita , Das Mayukh , Patel Manish R. 
Published: May 2021

Abstract
MEDI4276 is a biparatopic tetravalent antibody targeting two nonoverlapping epitopes in subdomains 2 and 4 of the HER2 ecto-domain, with site-specific conjugation to a tubulysin-based microtubule inhibitor payload. MEDI4276 demonstrates enhanced cellular internalization and cytolysis of HER2-positive tumor cells in vitro. This was a first-in-human, dose-escalation clinical trial in patients with HER2-positive advanced or metastatic breast cancer or gastric cancer. MEDI4276 doses escalated from 0.05 to 0.9 mg/kg (60- to 90-minute intravenous infusion every 3 weeks). Primary endpoints were safety and tolerability; secondary endpoints included antitumor activity (objective response, progression-free survival, and overall survival), pharmacokinetics, and immunogenicity. Forty-seven patients (median age 59 years; median of seven prior treatment regimens) were treated. The maximum tolerated dose was exceeded at 0.9 mg/kg with two patients experiencing dose-limiting toxicities (DLTs) of grade 3 liver function test (LFT) increases, one of whom also had grade 3 diarrhea, which resolved. Two additional patients reported DLTs of grade 3 LFT increases at lower doses (0.4 and 0.6 mg/kg). The most common (all grade) drug-related adverse events (AEs) were nausea (59.6%), fatigue (44.7%), aspartate aminotransferase (AST) increased (42.6%), and vomiting (38.3%). The most common grade 3/4 drug-related AE was AST increased (21.3%). Five patients had drug-related AEs leading to treatment discontinuation. In the as-treated population, there was one complete response (0.5 mg/kg; breast cancer), and two partial responses (0.6 and 0.75 mg/kg; breast cancer)—all had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). MEDI4276 has demonstrable clinical activity but displays intolerable toxicity at doses &gt;0.3 mg/kg.
Nrg1β Released in Remote Ischemic Preconditioning Improves Myocardial Perfusion and Decreases Ischemia/Reperfusion Injury via ErbB2-Mediated Rescue of Endothelial Nitric Oxide Synthase and Abrogation of Trx2 Autophagy
Authors: Kundumani-Sridharan Venkatesh , Subramani Jaganathan , Owens Cade , Das Kumuda C. 
Published: May 2021

Objective:
Remote ischemic preconditioning (RIPC) is an intervention process where the application of multiple cycles of short ischemia/reperfusion (I/R) in a remote vascular bed provides protection against I/R injury. However, the identity of the specific RIPC factor and the mechanism by which RIPC alleviates I/R injury remains unclear. Here, we have investigated the identity and the mechanism by which the RIPC factor provides protection.

Approach and ResultS:
Using fluorescent in situ hybridization and immunofluorescence, we found that RIPC induces Nrg1β expression in the endothelial cells, which is secreted into the serum. Whereas, RIPC protected against myocardial apoptosis and infarction, treatment with neutralizing-Nrg1 antibodies abolished the protective effect of RIPC. Further, increased superoxide anion generated in RIPC is required for Nrg1 expression. Improved myocardial perfusion and nitric oxide production were achieved by RIPC as determined by contrast echocardiography and electron spin resonance. However, treatment with neutralizing-Nrg1β antibody abrogated these effects, suggesting Nrg1β is a RIPC factor. ErbB2 (Erb-B2 receptor tyrosine kinase 2) is not expressed in the adult murine cardiomyocytes, but expressed in the endothelial cells of heart which is degraded in I/R. RIPC-induced Nrg1β interacts with endothelial ErbB2 and thereby prevents its degradation. Mitochondrial Trx2 (thioredoxin) is degraded in I/R, but rescue of ErbB2 by Nrg1β prevents Trx-2 degradation that decreased myocardial apoptosis in I/R.

Conclusions:
Nrg1β is a RIPC factor that interacts with endothelial ErbB2 and prevents its degradation, which in turn prevents Trx2 degradation due to phosphorylation and inactivation of ATG5 (autophagy-related 5) by ErbB2. Nrg1β also restored loss of eNOS (endothelial nitric oxide synthase) function in I/R via its interaction with Src.
Homocysteine Is Associated With Future Venous Thromboembolism in 2 Prospective Cohorts of Women
Authors: Aday Aaron W. , Duran Edward K. , Van Denburgh Martin , Kim Eunjung , Christen William G. , Manson JoAnn E. , Ridker Paul M , Pradhan Aruna D. 
Published: May 2021

Objective:
Case-control studies have identified plasma homocysteine as a risk marker for venous thromboembolism (VTE). Prospective data, particularly among women, are sparse. We examined whether plasma homocysteine associates with incident VTE in 2 large prospective cohorts of women.

Approach and Results:

In the WHS (Women’s Health Study), a prospective cohort study of 27 555 women ≥45 years old and free of cardiovascular disease and VTE, we assessed baseline homocysteine concentration along with other thrombotic biomarkers for association with future VTE (n=743), pulmonary embolism (n=363), and deep vein thrombosis (n=545). We used a second cohort of 2672 women (n=102 VTE events) in the WAFACS (Women’s Antioxidant and Folic Acid Cardiovascular Study) to corroborate our findings. In age-adjusted analyses, elevated homocysteine, hsCRP (high-sensitivity C-reactive protein), fibrinogen, and sICAM-1 (soluble intercellular adhesion molecule-1) were associated with incident VTE (
P
for extreme quartile comparisons and
P
-trend <0.05). In multivariable models adjusting for body mass index and other traditional VTE risk factors, only the association for homocysteine persisted (HR
Q4
, 1.31 [95% CI, 1.06–1.63]). Elevated homocysteine levels were associated with unprovoked pulmonary embolism (HR
Q4
, 2.13 [95% CI, 1.30–3.51]) and deep vein thrombosis (HR
Q4
, 1.59 [95% CI, 1.05–2.40]) but not provoked events. In WAFACS, elevated homocysteine levels were also associated with VTE events (
P
-trend 0.023).

Conclusions:
Higher plasma homocysteine levels associate with VTE events in 2 cohorts of middle-aged and older women. Among VTE subtypes, homocysteine was associated with unprovoked, but not provoked, events. These data suggest a plausible biological role for homocysteine in the development of VTE.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT00000479, NCT00000541.