bluuebunny/crossref_metadata_2025_split huggingface dataset:
Feasibility and acceptability of a structured quality by design approach to enhancing the rigor of clinical studies at an academic health center
Authors: Moradi Hamid , Schneider Margaret , Streja Elani , Cooper Dan 
Published: August 2021

Abstract

Introduction:
Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions. Quality by design (QbD) is a framework for embedding quality into the design, conduct, and monitoring of clinical trials. Here we report the feasibility and acceptability of a process for implementing QbD in clinical research at an academic health center via multidisciplinary design studios aimed at identifying and prioritizing critical to quality (CTQ) factors.

Methods:
The Clinical Trial Transformation Initiative’s Principles Document served as a guide to identify and categorize key CTQ factors, defined as elements of a clinical trial that are critical to patient safety and data integrity. Individual trials were reviewed in CTQ design studios (CTQ-DS) and the feasibility and acceptability of this intervention was examined through post-meeting interviews and surveys.

Results:
Eight clinical research protocols underwent the QbD evaluation process. The protocols ranged from multicenter randomized clinical trials to nonrandomized investigator-initiated studies. A developmental evaluation informed the iterative refinement of the CTQ-DS process, and post-meeting surveys revealed that CTQ-DS were highly valued by principal investigators (PIs) and resulted in multiple protocol changes.

Conclusions:
The present study demonstrated that QbD principles can be implemented to inform the design and conduct of clinical research at an academic health center using multidisciplinary design studios aimed at identifying and prioritizing CTQ elements. This approach was well received by the participants including study PIs. Future research will need to evaluate the effectiveness of this approach in improving the quality of clinical research.
Enabling Readiness of a School to Reopen During a Pandemic – A Field Experience
Authors: Baskaran Pritish , Raghav Pankaja , Naveen K. H. , Saurabh Suman 
Published: August 2021

AbstractModeling studies indicate that the closure of schools during the coronavirus disease (COVID-19) pandemic may not be well grounded for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as evidences indicate that children are less affected by this virus, and the clinical attack rates in the 0–19 age group are low. Experts also opine that school closures might have negative effects on the scholastic abilities of children and also an adverse impact on the economy and health care system, considering the responsibilities conferred upon the parents. Also, in a developing country like India, it is difficult for the rural population to afford distance online learning, which brings into importance the reopening of schools in a safe environment to avoid adversities such as increased drop-outs in the upcoming academic year, loss of in-person benefits such as mid-day meal scheme. This study highlights a field experience in relation to readiness assessment of a rural school in the Jodhpur district of Rajasthan, India, for a safe reopening to accept students in a safe and conducive atmosphere, which shall help prevent transmission of the virus in the schools among the children. In this regard, an indigenous readiness checklist has been developed to achieve the purpose, which assesses the readiness in 3 domains: (1) procedural readiness; (2) supplies, sanitation, and infrastructure-related; and (3) education and training.
A meta-analysis of the impact of open innovation on performance
Authors: Nguyen Thi Phuong Thao , Huang Fang , Tian Xiaowen 
Published: August 2021

AbstractUsing the meta-analysis technique, this research comprehensively reviews the existing open innovation (OI) literature, systematically aggregates empirical findings on the impact of OI on performance to identify key moderators and statistically tests the significance of these moderators in influencing the OI–performance relationship. Based on a comprehensive dataset of 2,377,123 firms and sub-firm units in 171 studies published from 2003 to 2018, this research demonstrates that the OI–performance relationship is significantly moderated by three key factors: performance measure, OI approach, and level of analysis. This research helps explain the conflicting findings regarding the OI–performance relationship in the existing literature, and contributes to the understanding of the effectiveness of OI practice.
A new alligatoroid (Eusuchia, Crocodylia) from the Eocene of China and its implications for the relationships of Orientalosuchina
Authors: Shan Hsi-yin , Wu Xiao-Chun , Sato Tamaki , Cheng Yen-nien , Rufolo Scott 
Published: August 2021

AbstractA new crocodylian, Dongnanosuchus hsui n. gen. n. sp., is described mainly based on four well-preserved skulls from the Eocene Youganwo Formation of the Maoming Basin, southeastern China. It is an alligatoroid and phylogenetically nested within the Orientalosuchina. Dongnanosuchus hsui n. gen. n. sp. differs from all other orientalosuchines primarily in certain features of the skull: (1) a preorbital ridge connects posteriorly with the dorsal orbital rim and a ridge around the anteroventral margin of the orbit, (2) the palatine is short and does not reach the posterior border of the suborbital fenestra, (3) the external mandibular fenestra is closed, and (4) the splenial joins the formation of the mandibular symphysis. The discovery of Dongnanosuchus hsui n. gen. n. sp. confirms the monophyly and North American origin of the Orientalosuchina but suggests that the clade dispersed to Asia via Beringia after diverging from the mainline rather than a sub-lineage of the Alligatoroidea in the Late Cretaceous.UUID: http://zoobank.org/f8ca22f1-6323-462e-bf32-03c6a164c82e.
Last step to the throne: the conflict between rulers and their successors
Authors: Zhou Congyi 
Published: August 2021

AbstractI model the dynamic between ruler and successor. The ruler cultivates a successor for a smooth power transition but fears being ousted by him, while the successor fears being removed by the ruler. The successor accumulates power while not threatening the ruler, and he prolongs their relationship by maintaining a low profile. The ruler gradually becomes more intolerant of the successor's growing power but, as his life nears its end, has less incentive to replace the successor. Thus conflict is most probable in the middle of their relationship; moreover, a predetermined succession order could increase its likelihood by restricting the ruler's choice. In the multi-candidate case, the strong candidate has some advantage but conflict is more likely to occur.
‘Yet another guitar recital filled the Wigmore Hall’: The Popularization of the Classical Guitar in Britain,c.1950–c.1970
Authors: RUSSELL DAVE 
Published: August 2021

AbstractThe popularity of the classical guitar in Britain surged between 1950 and 1970. The virtuosity of elite professionals led by the pioneering Andrés Segovia and the new stars Julian Bream and John Williams earned the classical instrument considerable purchase within the wider culture. Above all, it inspired thousands of largely middle-class, male, relatively young and urban amateur players, attracted not simply by the instrument’s intrinsic appeal but also by the opportunity offered to display a fashionable modernity and sophisticated connoisseurship. However, although securing for the classical guitar a much-enhanced musical role, these enthusiasts also created an often inward-looking specialist culture.
Prescribing intranasal steroids in HIV-positive patients: systematic review of the literature
Authors: Seymour N , Robinson M , Richardson D , Mohammed H , Williams D , McGilligan J A 
Published: August 2021

AbstractBackgroundThere are significant drug–drug interactions between human immunodeficiency virus antiretroviral therapy and intranasal steroids, leading to high serum concentrations of iatrogenic steroids and subsequently Cushing's syndrome.MethodAll articles in the literature on cases of intranasal steroid and antiretroviral therapy interactions were reviewed. Full-length manuscripts were analysed and the relevant data were extracted.ResultsA literature search and further cross-referencing yielded a total of seven reports on drug–drug interactions of intranasal corticosteroids and human immunodeficiency virus protease inhibitors, published between 1999 and 2019.ConclusionThe use of potent steroids metabolised via CYP3A4, such as fluticasone and budesonide, are not recommended for patients taking ritonavir or cobicistat. Mometasone should be used cautiously with ritonavir because of pharmacokinetic similarities to fluticasone. There was a delayed onset of symptoms in many cases, most likely due to the relatively lower systemic bioavailability of intranasal fluticasone.
Treatment outcomes in patients with laryngotracheal lesions and compromised airway during and prior to the coronovirus disease 2019 pandemic: a tertiary institution's experience
Authors: Gombert E , Ishii A , Guilcher P , Gorostidi F , Cantarella G , Pignataro L , Sandu K 
Published: August 2021

AbstractObjectiveThis study aimed to compare treatment outcomes in patients with laryngeal and tracheal stenosis treated during and prior to the coronavirus disease 2019 pandemic period.MethodPatients treated for laryngotracheal lesions with impending airway compromise during the active pandemic period were matched with those treated for similar lesions in the preceding years in a monocentric tertiary hospital setting.ResultsDuring the pandemic period of 55 days, 31 patients underwent 47 procedures. Seven patients (2 children, 5 adults) had open airway surgery, and one had an operation-specific complication. Twenty-four patients (10 children, 14 adults) underwent 40 endoscopic interventions without any complications. Operation specific results during and prior to the pandemic were comparable.ConclusionThe management strategy in patients with laryngotracheal lesions and impending airway compromise should not be altered during periods of risk from coronavirus disease 2019. Avoiding a tracheostomy by performing primary corrective surgery or proceeding with a definitive decannulation would be beneficial in these patients to reduce the risk of contagion.
The language of space and ownership in rural New South Wales in the mid-nineteenth-century: rural workers
Authors: Byrne Paula Jane 
Published: August 2021

AbstractLanguage used in depositions in colonial New South Wales shows a mobile non-Aboriginal society of close surveillance, rumour and informing. This derived from the convict system. In response to this there was considerable play with marking and markers, including the widespread use of nicknames and emphasis on personal space. Outside of this was the dreamlike realm of entertainment to be had in public houses, Aboriginal camps and Chinese tents at the diggings. Aboriginal politics was present at all of these places but Aboriginal camps were also places of considerable danger.
On (co)products of partial combinatory algebras, with an application to pushouts of realizability toposes
Authors: Zoethout Jetze 
Published: August 2021

AbstractWe consider two preorder-enriched categories of ordered partial combinatory algebras: OPCA, where the arrows are functional (i.e., projective) morphisms, and OPCA†, where the arrows are applicative morphisms. We show that OPCA has small products and finite biproducts, and that OPCA† has finite coproducts, all in a suitable 2-categorical sense. On the other hand, OPCA† lacks all nontrivial binary products. We deduce from this that the pushout, over Set, of two nontrivial realizability toposes is never a realizability topos. In contrast, we show that nontrivial subtoposes of realizability toposes are closed under pushouts over Set.
Evaluation of arterial stiffness and central blood pressure by oscillometric method in normotensive offspring of hypertensive parents
Authors: Yildirim Cansu Sivrikaya , Kosger Pelin , Akin Tugcem , Ucar Birsen 
Published: August 2021

AbstractChildren with a family history of hypertension have higher blood pressure and hypertensive pathophysiological changes begin before clinical findings. Here, the presence of arterial stiffness was investigated using central blood pressure measurement and pulse wave analysis in normotensive children with at least one parent with essential hypertension. Twenty-four-hour ambulatory pulse wave analysis monitoring was performed by oscillometric method in a study group of 112 normotensive children of hypertensive parents aged between 7 and 18 comparing with a control group of 101 age- and gender-matched normotensive children of normotensive parents. Pulse wave velocity, central systolic and diastolic blood pressure, systolic, diastolic and mean arterial blood pressure values were higher in the study group than the control group (p < 0.001, p = 0.002, p = 0.008, p = 0.001, p = 0.005, p = 0.001, p = 0.001, respectively). In all age groups (7–10, 11–14, and 15–18 years), pulse wave velocity was higher in the study group than the control group (p < 0.001). Pulse wave velocity was higher in children whose both parents are hypertensive compared to the children whose only mothers are hypertensive (p = 0.011). Pulse wave velocity values were positively correlated with age, weight, height, and body mass index (p < 0.05). Higher pulse wave velocity, central systolic and diastolic blood pressure values detected in the study group can be considered as early signs of hypertensive vascular changes. Pulse wave analysis can be a reliable, non-invasive, and reproducible method that can allow taking necessary precautions regarding lifestyle to prevent disease and target organ damage by detecting early hypertensive changes in genetically risky children.
Axillary arterial access for balloon dilatation of coarctation of aorta in newborns: a case series
Authors: Vanani Jignesh , Aggarwal Neeraj , Agarwal Mridul , Joshi Reena K. , Joshi Raja 
Published: August 2021

AbstractBalloon dilatation of coarctation of aorta is a standard of care for the patients presenting with severe left ventricular dysfunction. It can be performed through femoral, carotid, and axillary arterial access. Very few case series were available in the literature through axillary arterial access, despite being its advantage as non-end artery and easily palpable in coarctation of aorta. We present our experience with five cases of neonatal coarctation of aorta with severe left ventricular dysfunction where successful balloon dilatation of coarctation of aorta was performed via axillary approach without adverse events.
Implementing effective salt reduction programs and policies in low- and middle-income countries: learning from retrospective policy analysis in Argentina, Mongolia, South Africa and Vietnam
Authors: Webster Jacqui , Santos Joseph Alvin , Hogendorf Martyna , Trieu Kathy , Rosewarne Emalie , McKenzie Briar , Allemandi Lorena , Enkhtungalag Batsaikhan , Do Ha Thi Phuong , Naidoo Pamela , Farrand Clare , Waqanivalu Temo , Cobb Laura , Buse Kent , Dodd Rebecca 
Published: August 2021

AbstractObjective:To understand the factors influencing the implementation of salt reduction interventions in low- and middle-income countries (LMIC).Design:Retrospective policy analysis based on desk reviews of existing reports and semi-structured stakeholder interviews in four countries, using Walt and Gilson’s ‘Health Policy Triangle’ to assess the role of context, content, process and actors on the implementation of salt policy.Setting:Argentina, Mongolia, South Africa and Vietnam.Participants:Representatives from government, non-government, health, research and food industry organisations with the potential to influence salt reduction programmes.Results:Global targets and regional consultations were viewed as important drivers of salt reduction interventions in Mongolia and Vietnam in contrast to local research and advocacy, and support from international experts, in Argentina and South Africa. All countries had population-level targets and written strategies with multiple interventions to reduce salt consumption. Engaging industry to reduce salt in foods was a priority in all countries: Mongolia and Vietnam were establishing voluntary programs, while Argentina and South Africa opted for legislation on salt levels in foods. Ministries of Health, the WHO and researchers were identified as critical players in all countries. Lack of funding and technical capacity/support, absence of reliable local data and changes in leadership were identified as barriers to effective implementation. No country had a comprehensive approach to surveillance or regulation for labelling, and mixed views were expressed about the potential benefits of low sodium salts.Conclusions:Effective scale-up of salt reduction programs in LMIC requires: (1) reliable local data about the main sources of salt; (2) collaborative multi-sectoral implementation; (3) stronger government leadership and regulatory processes and (4) adequate resources for implementation and monitoring.
African Perspectives on Programs for North American Students in Africa: The Experience of the University of Zimbabwe
Authors: Zinyemba Ranga 
Published: August 2021

About three and half months before I left for Zimbabwe, I went to one of those parties where you only know the friend you came with. I ended up talking to a well-traveled guy wearing a striped wool scarf. At some point, I mentioned I was leaving for Zimbabwe in not so very long. This guy looked straight at me, his eyes big with suspicion over the stripes, and asked me exactly what good I thought the trip would do me.So I told him I was going to study women and literature; I outlined my whole approved proposal. And I told him what a great opportunity it would be. But he was looking more and more disdainful, and I mumbled to a stop.
Influence of time of day on dicamba and glyphosate efficacy
Authors: Kalina Jacob R. , Corkern Chris B. , Shilling Donn G. , Basinger Nicholas T. , Grey Timothy L. 
Published: August 2021

AbstractRenewed interest in studying auxin herbicides (WSSA Group 4) is increasing as a result of the release of genetically engineered crop varieties that are tolerant to preemergence and postemergence applications of specific formulations of dicamba. Auxin-resistant crops were developed in response to the development of weed species resistant to glyphosate and other herbicides. Research was conducted at multiple field locations in Georgia in 2018 and 2019 to examine weed control when postemergence herbicides were applied to dicamba- and glyphosate-resistant cotton at eight different points in time over a 24-h period. Applications were made at 1 h prior to sunrise all the way up to midnight during the same day to examine the effect of herbicide application timing on broadleaf weed control. Glyphosate, dicamba, and glyphosate plus dicamba were applied at each timing. Visual ratings of weed control were scored at 7, 14, 21, and 28 d after treatment (DAT). Weed control was affected by herbicide application timing. Midnight applications resulted in the lowest levels of control. Sicklepod, pitted morningglory, and prickly sida control was 49%, 38%, and 41%, respectively. Greatest control of all three species (up to 99%) occurred from the noon to 1 h prior to sunset application timings. Orthogonal contrasts of timing of application indicated that weed control was improved with day > night and pre-dawn > midnight.
Influence of IMF‐By on the Equatorial Ionospheric Plasma Drifts: TIEGCM Simulations
Authors: Hui Debrup , Vichare Geeta 
Published: August 2021

AbstractThe influence of east‐west component of interplanetary magnetic field (IMF‐By) on ionospheric plasma convection over polar region is well established by both observation and modeling studies. However, its influence beyond polar latitudes has rarely been addressed. To understand the effects of IMF‐By at low‐latitudes during geomagnetic storm times, we have designed simulation experiments using Thermosphere‐Ionosphere‐Electrodynamics General Circulation Model. This communication shows that strong IMF‐By and its polarity has effects on the storm‐time ionosphere‐thermosphere dynamics even near equator. It can change zonal electric field, magnitude of morning/evening time pre‐reversal‐enhancements (PRE) and meridional winds. At the storm onset when prompt penetration electric fields prevail, a strong IMF‐By, in general, reduces the vertical plasma drifts over the equator and the largest effects are observed near sunrise and sunset terminators. Later when disturbance dynamo is active, morning PRE appears, and a strongly positive IMF‐By strengthens morning PRE and weakens evening PRE, with respect to zero IMF‐By conditions. A strongly negative IMF‐By just shows the reverse, thus indicates dawn‐dusk asymmetry due to IMF‐By. It is also seen that the meridional winds are oppositely directed during positive and negative IMF‐By conditions. The effects of IMF‐By transition are observed on the evening PRE within 2 h from the transition. The new insights successfully explain the observations from a few earlier available works. However, the presented results should be treated with caution in view of model limitations associated with the empirical patterns of high latitude convection and preliminary scheme of merging high latitude‐low latitude potentials.
Electrostatic Model for Antenna Signal Generation From Dust Impacts
Authors: Shen Mitchell M. , Sternovsky Zoltan , Garzelli Alessandro , Malaspina David M. 
Published: August 2021

AbstractDust impacts on spacecraft are commonly detected by antenna instruments as transient voltage perturbations. The signal waveform is generated by the interaction between the impact‐generated plasma cloud and the elements of the antenna–spacecraft system. A general electrostatic model is presented that includes the two key elements of the interaction, namely the charge recollected from the impact plasma by the spacecraft and the fraction electrons and cations that escape to infinity. The clouds of escaping electrons and cations generate induced signals, and their vastly different escape speeds are responsible for the characteristic shape of the waveforms. The induced signals are modeled numerically for the geometry of the system and the location of the impact. The model employs a Maxwell capacitance matrix to keep track of the mutual interaction between the elements of system. A new reduced‐size model spacecraft is constructed for laboratory measurements using the dust accelerator facility. The model spacecraft is equipped with four antennas: two operating in a monopole mode, and one pair configured as a dipole. Submicron‐sized iron dust particles accelerated to >20 km/s are used for test measurements, where the waveforms of each antenna are recorded. The electrostatic model provides a remarkably good fit to the data using only a handful of physical fitting parameters, such as the escape speeds of electrons and cations. The presented general model provides the framework for analyzing antenna waveforms and is applicable for a range of space missions investigating the distribution of dust particles in relevant environments.