bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol of Tecopox study: a multicentre, open-label, double-arm trial to evaluate the efficacy and safety of oral tecovirimat therapy for patients with smallpox or monkeypox
Authors: Suzuki Tetsuya , Saito Sho , Tsuzuki Shinya , Ashida Shinobu , Takakusaki Mizue , Yoshikawa Tomoki , Shimojima Masayuki , Ebihara Hideki , Ohmagari Norio , Morioka Shinichiro 
Published: August 2023

IntroductionMonkeypox was originally endemic locally in West Africa; however, outbreaks in non-endemic countries have been recognised since May 2022. The effectiveness of tecovirimat has been estimated against smallpox, which belongs to the sameOrthopoxvirusgenus as monkeypox. Thus, tecovirimat is expected to be effective against monkeypox. This study aims to evaluate the efficacy and safety of oral tecovirimat therapy for patients with smallpox and monkeypox and to prepare a scheme for oral tecovirimat use in Japan.Methods and analysisThis nationwide, multicentre, non-randomised, open-label, double-arm study will involve viral examination of the blood, throat swabs, urine and skin lesions, performed periodically. Participants will freely decide whether to participate in an administered group (supportive treatment plus oral tecovirimat) or a non-administered group (only supportive treatment). Tecovirimat will be administered for 14 days. To ensure that financial problems do not preclude participation in the study, the research fund will cover the cost of tecovirimat and basic hospitalisation fees. The primary endpoint is the percentage of patients with negative PCR results (cycle threshold value ≥40) for skin lesion specimens at 14 days after inclusion in the study. Secondary endpoints include mortality at 14 and 30 days, viral load in each sample, duration of fever and adverse events. The sample size is estimated to be 50 patients with monkeypox or smallpox.Ethics and disseminationWritten informed consent will be obtained from all participants. This study was approved by the Certified Review Board of National Center for Global Health and Medicine and published in the Japan Registry of Clinical Trials. The results of this study will be published in peer-reviewed journals and/or in presentations at academic conferences.Trial registration numberjRCTs031220169.
Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial
Authors: Wright Nunes Julie A , Resnicow Ken , Richardson Caroline , Levine Diane , Kerr Eve , Saran Rajiv , Gillespie Brenda , Bragg-Gresham Jennifer , Delacroix Emerson L , Considine Shannon , Fan Audrey , Ellies Tammy , Garcia-Guzman Luis , Grzyb Katie , Klinkman Michael , Rockwell Pamela , Billi John , Martin Carly , Collier Kristin , Parker-Featherstone Ebony , Bryant Nicole , Seitz Maria , Lukela Jennifer , Brinley Floyd John , Fagerlin Angela 
Published: August 2023

IntroductionChronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3–5. Outcomes in patients with CKD stages 3–5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching.Methods and analysisWe will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3–5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination.Ethics and disseminationThis study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations.Trial registration numberNCT04087798.
Risk of sexual dysfunctions in breastfeeding females: protocol for a systematic review and meta-analysis
Authors: Smetanina Darya , Awar Shamsa Al , Khair Howaida , Alkaabi Meera , Das Karuna M , Ljubisavljevic Milos , Statsenko Yauhen , Zaręba Kornelia Teresa 
Published: August 2023

BackgroundEpidemiological studies do not provide accurate statistics on the percentage of breastfeeding women experiencing sexual dysfunctions and restraining from sexual activity. The data vary between 40% and 83% in the first group and 20–50% in the second one. Despite excessive studies on contributors to intimacy changes, breast feeding received little attention from researchers. The relationship between lactation and postpartum sexual dysfunctions remains unclear. This systematic review and meta-analysis will synthesise available data and establish the link between breast feeding and sexuality problems.Methods and analysisA comprehensive literature search will be performed in biomedical databases PubMed/Medline, Scopus, Web of Science, EMBASE and CINAHL. We will extract peer-reviewed original studies written in English, Arabic or Polish from 2000 to June 2023. We will also search for reports from international health organisations and local health authorities. The preliminary search was performed on 04 April 2023. The studies must provide data on dysfunction prevalence/incidence and the strength of the relationship between breast feeding and sexuality in generally healthy women. The Covidence software will be used to perform literature screening, data extraction and quality assessment of individual studies. We will use a random-effects model meta-analysis to calculate pooled weighted frequency measures and effect size. Between-study heterogeneity will be assessed with the I2test.Ethics and disseminationThis meta-analysis does not require ethical approval because it synthesises data from previously published original studies. The final work will be published in a peer-reviewed journal and presented at scientific conferences.PROSPERO registration numberCRD42023411053.
Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
Authors: Garrison Scott R , Youngson Erik , Perry Danielle A , Campbell Farah N , Kolber Michael R , Korownyk Christina , Allan Gary Michael , Green Lee , Bakal Jeffrey 
Published: August 2023

IntroductionBedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects.Methods and analysisDesign: Prospective parallel randomised, open-label, blinded end-point trial.Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.Sample size: The trial will continue until a projected 368 primary outcome events have occurred.Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years).Ethics and disseminationBedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal.Trial registration numberNCT04054648.
América latina: la trampa para las clases reinantes
Authors: Cueva Perus Marcos 
Published: August 2023

Este artículo se propone examinar algunas de las contradicciones sociales en las que se desenvuelven los gobiernos latinoamericanos actuales, en particular los progresistas. A partir de lo que entiende Michel Foucault por “soberanía” y mediante una metodología hipotético-deductiva, se afirma que la región latinoamericana, pese a la penetración capitalista generalizada, conserva rasgos arcaicos no sencillos de desterrar. Habida cuenta de un estado de crisis y de desnacionalización, bajo fuerte influencia estadounidense, ciertas “capas ideológicas y políticas”, no desligadas de las capas medias, podrían haberse visto llamadas a gestionarlo, pero sin cambiar estructuras de raíz, en un tipo de proceso que ya ha ocurrido antes en la historia. Desde este punto de vista, sigue siendo importante distinguir entre clase dirigente y “clase reinante”, y recordar que “progresismo”, a fin de cuentas, no es sinónimo de acceso de los sectores populares al poder, sobre todo en sociedades polarizadas.
Resumo: Este artigo pretende examinar algumas das contradições sociais nas quais operam os atuais governos latino-americanos, particularmente os progressistas. Partindo do que Michel Foucault entende por “soberania” e por meio de uma hipotética metodologia dedutiva, afirma-se que a região latino-americana, apesar da penetração capitalista generalizada, preserva traços arcaicos que não são fáceis de banir. Dado um estado de crise e desnacionalização, sob forte influência dos EUA, na crise, certas "camadas ideológicas e políticas", não desvinculadas das camadas médias, poderiam ter sido chamadas a geri-la, mas sem alterar as estruturas de raiz, de uma forma processo que já aconteceu antes na história. Desse ponto de vista, ainda é importante distinguir entre classe dominante e “classe reinante”, e lembrar que “progressismo”, afinal, não é sinônimo de acesso ao poder para os setores populares, especialmente em sociedades polarizadas .

Abstract: This article intends to examine some of the social contradictions in which current Latin American governments operate, particularly the progressive ones. Starting from what Michel Foucault understands by “sovereignty” and through a hypothetical deductive methodology, it is affirmed that the Latin American region, despite the generalized capitalist penetration, preserves archaic features that are not easy to banish. Given a state of crisis and denationalization, under strong US influence, in the crisis, certain "ideological and political layers", not detached from the middle layers, could have been called upon to manage it, but without changing root structures, in a kind of process that has happened before in history. From this point of view, it is still important to distinguish between the ruling class and the “class which reigns”, and to remember that “progressivism”, after all, is not synonymous with access to power for the popular sectors, especially in polarized societies.
Myocardial Fibrosis and Cardiomyopathy Risk: A Genetic Link in the MESA
Authors: Shabani Mahsima , Wang Min , Jenkins Gregory D. , Rotter Jerome I. , Rich Stephen S. , Batzler Anthony , Taylor Kent D. , Mychaleckyj Josyf C. , Liu Duan , Lima Joao A.C. , Pereira Naveen L. 
Published: August 2023

BACKGROUND:
Common genetic variants are associated with risk for hypertrophic cardiomyopathy and dilated cardiomyopathy and with left ventricular (LV) traits. Whether these variants are associated with myocardial fibrosis, an important pathophysiological mediator of cardiomyopathy, is unknown.

METHODS:
Multi-Ethnic Study of Atherosclerosis participants with T1-mapping cardiac magnetic resonance imaging in-whom extracellular volume was assessed, and genotyping information was available were included (N=1255). Log extracellular volume (%) was regressed on 50 candidate single nucleotide polymorphisms (previously identified to be associated with hypertrophic cardiomyopathy, dilated cardiomyopathy, and LV traits) adjusting for age, sex, diabetes, blood pressure, and principal components of ancestry. Ancestry-specific results were pooled by fixed-effect meta-analyses. Gene knockdown experiments were performed in human cardiac fibroblasts.

RESULTS:

The
SMARCB1
rs2186370 intronic variant (minor allele frequency: 0.18 in White and 0.50 in Black participants), previously identified as a risk variant for dilated cardiomyopathy and hypertrophic cardiomyopathy, was significantly associated with increased extracellular volume (
P=
0.0002) after adjusting for confounding clinical variables. The
SMARCB1
rs2070458 locus previously associated with increased LV wall thickness and mass was similarly significantly associated with increased extracellular volume (
P=
0.0002). The direction of effect was similar in all 4 ancestry groups, but the effect was strongest in Black participants. The variants are strong expression quantitative loci in human LV tissue and associated with genotype-dependent decreased expression of
SMARCB1
(
P=
7.3×10
-22
).
SMARCB1
knockdown in human cardiac fibroblasts resulted in increased TGF (transforming growth factor)-β1–mediated α-smooth muscle actin and collagen expression.

CONCLUSIONS:

Common genetic variation in
SMARCB1
previously associated with risk for cardiomyopathies and increased LV wall thickness is associated with increased cardiac magnetic resonance imaging–based myocardial fibrosis and increased TGF-β1 mediated myocardial fibrosis in vitro. Whether these findings suggest a pathophysiologic link between myocardial fibrosis and cardiomyopathy risk remains to be proven.
Revisiting mandibular symphyseal shape in juvenile early hominins and modern humans using a deformation-based approach
Authors: Zimmer Veronika A. , Oettlé Anna , Hoffmann Jakobus , Thackeray John Francis , Zipfel Bernhard , Braga José 
Published: August 2023

Abstract
The juvenile mandible is important in the investigation of ontogenetic and evolutionary changes among early hominins. We revisit the mandibular symphysis in juvenile specimens of Australopithecus africanus and Paranthropus robustus with two main contributions. First, we employ, for the first time, methods of computational anatomy to model complex symphyseal shape differences. Second, we present new fossil evidence from Kromdraai to improve our knowledge of symphyseal morphology. We describe differences between shapes by landmark-free diffeomorphism needed to align them. We assess which features of the mandibular symphysis best discriminate the juvenile symphysis in these fossil species, relative to the intraspecific variation observed among modern humans. Our approach eliminates potential methodological inconsistencies with traditional approaches (i.e., the need for homologous anatomical landmarks, assumption of linearity). By enabling detailed comparisons of complex shapes in juvenile mandibles, our proposed approach offers new perspectives for more detailed comparisons among Australopithecus, Paranthropus and early Homo.
International Legal Responses for Protecting Fishers’ Fundamental Rights Impacted by a Changing Ocean
Authors: Nakamura Julia , Cirne Lima Weston Julia , Lennan Mitchell 
Published: August 2023

Abstract
Climate change directly impacts the marine landscape where fishers operate. Most fishers rely on fishing for food, income and/or employment. A changing ocean can therefore significantly impact fishers’ lives and hinder the full exercise of their rights of access to fisheries resources, rights to fish, to food, to work, to culture, and to a healthy, clean and sustainable environment. This article questions whether international law supports the protection of fishers’ fundamental rights in the changing ocean context. The authors begin by elucidating what such context means to fishers and their rights, taking special account of small-scale fishers and vulnerable groups. The obligations of States Parties to key instruments under the law of the sea and international climate change law, vis-à-vis States’ obligations under human rights treaties and other relevant international guidance, are explored with a view to furthering the protection of fishers impacted by a changing ocean.
Kuduro, Digital Music and Lifestyle in Diaspora
Authors: Marcon Frank 
Published: August 2023

Abstract
Kuduro is a style of dance and electronic music that emerged in Angola in the nineties, in a peculiar social context. Initially consumed and produced by young people from the periphery of the city of Luanda, it became a means of expression, entertainment, socialization and subsistence, through which they became autonomous and symbolically transformed their realities of scarcity. With access to communication technologies and movements of global dispersion of people and information, kuduro also spread to other countries and gained other meanings. Here, I analyze the characteristics of its context of origin, the conditions and implications of such dispersal, and disputes over the meanings of style.
« Etes-vous la victime d’un “isme”? »: emploi nominal et référentiel du suffixe –isme
Authors: Agabalian Grigory 
Published: August 2023

Abstract
This article addresses the nominal use of the suffix -isme in French, as in the sentence “êtes-vous la victime d’un isme?” (“are you the victim of an ism?”). Using data from a media corpus, first I observe that there are occurrences where the suffix -isme is indeed a noun with a referential meaning (i.e. referring to extralinguistic objects), refering to doctrines, movements, religions or attitudes. Then, I observe that the suffix -isme is associated with axiologically negative realities (especially conflict) in its nominal use. From this information, I try to answer two questions: what is isme the name of and how to describe the negative assessment associated to it?
Système numéral et neutralisation du genre numéral en soureth
Authors: Skaff Rola 
Published: August 2023

Abstract
This article describes the numeral system in several varieties of Soureth, one of the modern languages derived from the eastern branch of Aramaic, a Semitic language of the Northwest.
Historically, it has been spoken in Iraq, Syria, Iran, and southeastern Turkey; and in the diaspora since the early 20th century.
After describing the system in general, the article will study a particular phenomenon concerning the gender agreement between the numeral and the counted name. Modern Aramaic, like the classical language, Syriac, has a binary gender marking on the noun (masculine or feminine), which affects the relations of agreement. The numeral system also contains marked masculine and feminine forms that agree with the noun (Coghill 2004 & 2018, Poizat 2008). However, there is a process of gender neutralization of the numeral that occurs (Khan 2009). Indeed, numerals do not always change according to the gender of the name counted. They thus have a single form that could be called a “neutral” form.
This paper presents the different uses of numerals in an oral corpus made up with Soureth speakers living in France. Some hypotheses will be proposed in order to analyze the neutralization process which does not exist in an absolute way in all varieties.
Regard sur quelques facteurs de sélection des subordonnants relatifs du français par des apprenants norvégiens
Authors: Stenkløv Nelly Foucher , Helland Hans Petter , Larrivée Pierre 
Published: August 2023

Abstract
Acquisition of relative is subject to the Accessibility Hierarchy developed by Keenan and Comrie (1977), and should not be subject to mother tongue transfer effects, even if these are documented. The tension between transfer and hierarchy is therefore explored on the basis of the acquisition of French relatives by Norwegian learners. These are interesting because Norwegian has a different relative system from French, and Norwegian speakers are generally multilingual, multiplying the sources of transfer. The guided and free productions of beginner and intermediate Norwegian learners make it possible to establish not only the error rate, but also the position of the erroneous relative on the accessibility hierarchy. However, the relatives used incorrectly are not necessarily more accessible in the hierarchy than the relative which should be used. There are nonetheless potential interfering effects from the animacy value of the antecedent.