bluuebunny/crossref_metadata_2025_split huggingface dataset:
Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial
Authors: Van Doormaal Tristan , Germans Menno R , Sie Mariska , Brouwers Bart , Carlson Andrew , Dankbaar Jan Willem , Fierstra Jorn , Depauw Paul , Robe Pierre , Regli Luca 
Published: July 2021

ObjectiveThe dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.DesignFirst in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.SettingThree large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.ParticipantsForty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.InterventionEach patient received one DSP after cranial surgery and closure of the dura mater with sutures.Outcome measuresPrimary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.ResultsNo patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.ConclusionsDSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.Trial registration numberNCT03566602.
Study protocol to develop a core outcome set for thyroid dysfunction to bridge the unmet needs of patient-centred care
Authors: Ooi Cheow Peng , Yusof Khan Abdul Hanif Khan , Abdul Manaf Rosliza , Mustafa Norlaila , Sukor Norlela , Williamson Paula R , Kamaruddin Nor Azmi 
Published: July 2021

AbstractIntroductionThyroid dysfunctions (TD) are common medical conditions affecting all global populations. Improved healthcare leading to increasing survival rates and delayed diagnosis rendered significant burden of the disease in the increasing number of patients with TD with comorbid illnesses. Therefore, reducing the burden of TD and improving the quality of care are crucial. Existing poor-quality data that guide evidence-based decisions only provide a fragmented picture of clinical care. The different outcomes across studies assessing the effectiveness of treatments impede our ability to synthesise results for determining the most efficient treatments. This project aims to produce a core outcome set (COS), which embeds the multiple complex dimensions of routine clinical care for the effectiveness studies and clinical care of adult patients with TD.Methods and analysisThis mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.Ethics and disseminationThe study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.Registration detailsCore Outcome Measures in Effectiveness Trials (COMET) Initiative database registration:http://www.comet-initiative.org/studies/details/1371
DEveloping Tests for Endometrial Cancer deTection (DETECT): protocol for a diagnostic accuracy study of urine and vaginal samples for the detection of endometrial cancer by cytology in women with postmenopausal bleeding
Authors: Jones Eleanor R , Carter Suzanne , O"Flynn Helena , Njoku Kelechi , Barr Chloe E , Narine Nadira , Shelton David , Rana Durgesh , Crosbie Emma J 
Published: July 2021

IntroductionPostmenopausal bleeding (PMB), the red flag symptom for endometrial cancer, triggers urgent investigation by transvaginal ultrasound scan, hysteroscopy and/or endometrial biopsy. These investigations are costly, invasive and often painful or distressing for women. In a pilot study, we found that voided urine and non-invasive vaginal samples from women with endometrial cancer contain malignant cells that can be identified by cytology. The aim of theDEvelopingTests forEndometrialCancer deTection (DETECT) Study is to determine the diagnostic test accuracy of urine and vaginal cytology for endometrial cancer detection in women with PMB.Methods and analysisThis is a multicentre diagnostic accuracy study of women referred to secondary care with PMB. Eligible women will be asked to provide a self-collected voided urine sample and a vaginal sample collected with a Delphi screener before routine clinical procedures. Pairs of specialist cytologists, blinded to participant cancer status, will assess and classify samples independently, with differences settled by consensus review or involving a third cytologist. Results will be compared with clinical outcomes from standard diagnostic tests. A sample size of 2000 women will have 80% power to establish a sensitivity of vaginal samples for endometrial cancer detection by cytology of ≥85%±7%, assuming 5% endometrial cancer prevalence. The primary objective is to determine the diagnostic accuracy of urogenital samples for endometrial cancer detection by cytology. Secondary objectives include the acceptability of urine and vaginal sampling to women.Ethics and disseminationThis study has been approved by the North West–Greater Manchester West Research Ethics Committee (16/NW/0660) and the Health Research Authority. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via charity websites.Trial registration numberISRCTN58863784.
Risk of all-cause mortality associated with chronic obstructive pulmonary disease and the role of healthy ageing trajectories: a population-based study of middle-aged and older adults
Authors: Bayes-Marin Ivet , Sanchez-Niubo Albert , Fernández Daniel , Haro Josep Maria , Olaya Beatriz 
Published: July 2021

ObjectivesThe aims were to study the risk of all-cause mortality associated with chronic obstructive pulmonary disease (COPD) and healthy ageing trajectories (HAT) in three birth cohorts and to determine the moderating role of HAT in the association between COPD and all-cause mortality.DesignProspective cohort study.SettingData from waves 1 to 5 of The Survey of Health, Ageing and Retirement in Europe.ParticipantsThe total sample was 28 857 community-dwelling individuals aged 50+ years.Main outcomeAll-cause mortality associated with COPD and HAT adjusting for covariates. We performed Aalen additive hazards models to explore these associations. Interactions between COPD and HAT were also explored. Analyses were conducted separately in three birth cohorts (>1945, 1936–1945 and ≤1935). Latent class growth analysis was used to classify participants into HAT.ResultsThree parallel HAT were found in the three birth cohorts (‘low’, ‘medium’ and ‘high’ healthy ageing). Participants with COPD had an increased mortality risk, but this effect was no longer significant after adjusting for covariates. The ‘low’ HAT was associated with increased mortality risk in the three subsamples, although this effect was lower after adjustment. The interaction between COPD and HAT was significant only in the ≤1935 birth cohort, indicating that those with COPD and a ‘low’ trajectory had a greater risk of mortality.ConclusionsThe healthy ageing scale may be a suitable tool to identify patients at higher risk to mitigate disease burden and improve patients’ quality of life.
Mental health crisis in healthcare providers in the COVID-19 pandemic: a cross-sectional facility-based survey
Authors: Sung Chih-Wei , Chen Chi-Hsin , Fan Cheng-Yi , Chang Jia-How , Hung Chia Chun , Fu Chia-Ming , Wong Li Ping , Huang Edward Pei-Chuan , Lee Tony Szu-Hsien 
Published: July 2021

ObjectivesDuring a pandemic, healthcare providers experience increased mental and physical burden. Burnout can lead to treatment errors, patient mortality, increased suicidal ideation and substance abuse as well as medical malpractice suits among medical staff. This study aimed to investigate the occurrence of burnout, acute stress disorder, anxiety disorder and depressive disorder among healthcare providers at the third month of the COVID-19 pandemic.DesignA cross-sectional facility-based survey.SettingHospitals around the country with different levels of care.ParticipantsA total of 1795 respondents, including 360 men and 1435 women who participated in the survey.Primary outcome measuresBurnout was assessed using the Physician Work Life Study. A score of ≥3 implied burnout.ResultsOf the 1795 respondents, 723 (40.3%) reported burnout, and 669 (37.3%) cared for patients with COVID-19. Anxiety levels were mild in 185 (10.3%) respondents, moderate in 209 (11.6%) and severe in 1401 (78.1%). The mean Center for Epidemiologic Studies Depression Scale-10 score was 9.5±6.3, and 817 (45.5%) respondents were classified as having depression. Factors associated with burnout were working in acute and critical care (ACC) divisions (adjusted OR (aOR)=1.84, 95% CI 1.20 to 3.39, p=0.019), caring for patients with COVID-19 (aOR=3.90, 95% CI 1.14 to 13.37, p=0.031) and having depressive disorder (aOR=9.44, 95% CI 7.44 to 11.97, p<0.001).ConclusionsPhysicians and nurses are vulnerable to burnout during a pandemic, especially those working in ACC divisions. Anxiety disorder, depressive disorder and care of patients with COVID-19 may be factors that influence the occurrence of burnout among healthcare providers.
Diverse experts’ perspectives on ethical issues of using machine learning to predict HIV/AIDS risk in sub-Saharan Africa: a modified Delphi study
Authors: Nichol Ariadne A , Bendavid Eran , Mutenherwa Farirai , Patel Chirag , Cho Mildred K 
Published: July 2021

ObjectiveTo better understand diverse experts’ views about the ethical implications of ongoing research funded by the National Institutes of Health that uses machine learning to predict HIV/AIDS risk in sub-Saharan Africa (SSA) based on publicly available Demographic and Health Surveys data.DesignThree rounds of semi-structured surveys in an online expert panel using a modified Delphi approach.ParticipantsExperts in informatics, African public health and HIV/AIDS and bioethics were invited to participate.MeasuresPerceived importance of or agreement about relevance of ethical issues on 5-point unipolar Likert scales. Qualitative data analysis identified emergent themes related to ethical issues and development of an ethical framework and recommendations for open-ended questions.ResultsOf the 35 invited experts, 22 participated in the online expert panel (63%). Emergent themes were the inclusion of African researchers in all aspects of study design, analysis and dissemination to identify and address local contextual issues, as well as engagement of communities. Experts focused on engagement with health and science professionals to address risks, benefits and communication of findings. Respondents prioritised the mitigation of stigma to research participants but recognised trade-offs between privacy and the need to disseminate findings to realise public health benefits. Strategies for responsible communication of results were suggested, including careful word choice in presentation of results and limited dissemination to need-to-know stakeholders such as public health planners.ConclusionExperts identified ethical issues specific to the African context and to research on sensitive, publicly available data and strategies for addressing these issues. These findings can be used to inform an ethical implementation framework with research stage-specific recommendations on how to use publicly available data for machine learning-based predictive analytics to predict HIV/AIDS risk in SSA.
Travelling for abortion services in Mexico 2016–2019: community-level contexts of Mexico City public abortion clients
Authors: Jacobson Laura E , Saavedra-Avendano Biani , Fuentes-Rivera Evelyn , Schiavon Raffaela , Darney Blair G 
Published: July 2021

ObjectiveTo describe the community context of women who travel to access Mexico City’s public sector abortion programme and identify factors associated with travelling from highly marginalised settings.MethodsWe used data from the Interrupción Legal de Embarazo (ILE) programme (2016–2019) and identified all abortion clients who travelled from outside Mexico City. We merged in contextual information at the municipality level and used descriptive statistics to describe ILE clients’ individual characteristics and municipalities on several measures of vulnerability. We also compared municipalities that ILE clients travelled from with those where no one travelled from. We used logistic regression to identify factors associated with travelling to access ILE services from highly marginalised versus less marginalised municipalities.ResultsOur sample included 21 629 ILE clients who travelled to Mexico City from 491 municipalities within all 31 states outside Mexico City. The majority of clients travelled from the least marginalised (81.9%) and most populated (over 100 000 inhabitants; 91.3%) municipalities. Most (91.2%) ILE clients came from municipalities with adolescent fertility rates in the bottom three quintiles. Clients with a primary or secondary education (vs high school or more) and those from a municipality with a high adolescent fertility rate (top two quintiles) had higher odds of travelling from a highly marginalised (vs less) municipality (adjusted odds ratio (aOR) 1.46, 95% CI 1.35 to 1.58 and aOR 1.89, 95% CI 1.68 to 2.12, respectively).ConclusionILE clients travel from geographically and socioeconomically diverse communities. There is an unmet need for legal abortion across Mexico.
Effect of small vs large muscle mass endurance training on maximal oxygen uptake in organ transplanted recipients
Authors: del Torto Alessio , Capelli Carlo , Peressutti Roberto , di Silvestre Adriana , Livi Ugolino , Nalli Chiara , Sponga Sandro , Amici Gianpaolo , Baccarani Umberto , Lazzer Stefano 
Published: July 2021

Maximal oxygen consumption (V̇O2max) is impaired in heart (HTx), kidney (KTx), and liver (LTx) transplanted recipients and the contribution of the cardiovascular, central, and peripheral (muscular) factors in affecting V̇O2max improvement after endurance training (ET) has never been quantified in these patients. ET protocols involving single leg cycling (SL) elicit larger improvements of the peripheral factors affecting O2 diffusion and utilization than the double leg (DL) cycling ET. Therefore, this study aimed to compare the effects of SL-ET vs DL-ET on V̇O2max. We determined the DL-V̇O2max and maximal cardiac output before and after 24 SL-ET vs DL-ET sessions on 33 patients (HTx = 13, KTx = 11 and LTx = 9). The DL-V̇O2max increased by 13.8% ± 8.7 (p < 0.001) following the SL-ET, due to a larger maximal O2 systemic extraction; meanwhile, V̇O2max in DL-ET increased by 18.6% ± 12.7 (p < 0.001) because of concomitant central and peripheral adaptations. We speculate that in transplanted recipients, SL-ET is as effective as DL-ET to improve V̇O2max and that the impaired peripheral O2 extraction and/or utilization play an important role in limiting V̇O2max in these types of patients. Novelty: SL-ET increases V̇O2max in transplanted recipients because of improved peripheral O2 extraction and/or utilization. SL-ET is as successful as DL-ET to improve the cardiorespiratory fitness in transplanted recipients. The model of V̇O2max limitation indicates the peripheral factors as a remarkable limitation to the V̇O2max in these patients.
Fighting off field dependence in MSSM Higgs-mass corrections of order $$\alpha _t\,\alpha _s$$ and $$\alpha _t^2$$
Authors: Domingo Florian , Paßehr Sebastian 
Published: July 2021

AbstractThe connection between gauge and Higgs sectors makes supersymmetric extensions of the Standard Model predictive frameworks for the derivation of Higgs masses. In this paper, we study the contamination of such predictions by field-renormalization constants, in the MSSM with two-loop gaugeless corrections of $$\mathcal {O}\big (\alpha _{t,b}\,\alpha _s,\,\alpha _{t,b}^2\big )$$

O

(

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,
b

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s

,

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2

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and full momentum dependence, and demonstrate how strict perturbative expansions allow to systematically neutralize the dependence on such unphysical objects. On the other hand, the popular procedure consisting in an iterative pole search remains explicitly dependent on field counterterms. We then analyze the magnitude of the intrinsic uncertainty that this feature implies for the iterative method, both in non-degenerate and near-degenerate regimes, and conclude that this strategy does not improve on the predictions of the more straightforward expansion. We also discuss several features related to the inclusion of the orders $$\alpha _{t,b}\,\alpha _s$$

α

t
,
b

α
s

and $$\alpha _{t,b}^2$$

α

t
,
b

2

in the so-called ‘fixed-order’ approach, such as the resummation of UV-logarithms for heavy supersymmetric spectra.
Conformal Higgs model: Gauge fields can produce a 125 GeV resonance
Authors: Nesbet Robert K. 
Published: July 2021

Recent cosmological observations and compatible theory offer an understanding of long-mysterious dark matter and dark energy. The postulate of universal conformal local Weyl scaling symmetry, without dark matter, modifies action integrals for both Einstein–Hilbert gravitation and the Higgs scalar field by gravitational terms. Conformal theory accounts for both observed excessive external galactic orbital velocities and for accelerating cosmic expansion. SU(2) symmetry-breaking is retained by the conformal scalar field, which does not produce a massive Higgs boson, requiring an alternative explanation of the observed LHC 125 GeV resonance. Conformal theory is shown here to be compatible with a massive neutral particle or resonance [Formula: see text] at 125 GeV, described as binary scalars [Formula: see text] and [Formula: see text] interacting strongly via quark exchange. Decay modes would be consistent with those observed at LHC. Massless scalar field [Formula: see text] is dressed by the [Formula: see text] field to produce Higgs Lagrangian term [Formula: see text] with the empirical value of [Formula: see text] known from astrophysics.
Ruthenium-Exsolution Catalyst for Dry Reforming of Biogas
Authors: Frantz Cedric , Rumpf Lionel , López Solá Alex , Wang Ligang , Naeem Muhammad Awais , Müller Christoph R. , Van herle Jan 
Published: July 2021

Solid oxide fuel cells have a proven efficiency for the direct conversion of biogas into electricity, and their full potential from European agricultural and waste-water sites still has to be fully evaluated and harnessed. Biogases are methane-rich mixtures whose composition and trace contaminants, especially of sulfur compounds, can vary greatly.
To avoid carbon deposition from the carbon-rich CH4-CO2 mixtures, some amount of steam and/or extra CO2 needs to be added to process the biogas. Ideally this can be recovered from the SOFC exhaust. In a preparatory work, biogas/SOFC integrated systems were studied and compared using Aspen Plus[1]. Best performances are reached with a catalytic methane pre-reformer when a fraction of the anode off-gas is recirculated for mixing with the biogas feed. This work provided the guidelines for the present catalytic study and predicted thermodynamic equilibria of gas mixtures.
Here, the overall performance of a ruthenium exsolution catalyst[2] for the reforming of methane was evaluated for these different biogas compositions at various gas hourly space velocities. Gas chromatography and material balance calculations enabled the full measurement of inlet and outlet gas compositions which, in turn, permitted to calculate precise conversion rates, reforming ratio, and the deviation from thermodynamic equilibrium. Methane conversion reached >95 % for a dry-dominant reforming mixture, which simplifies the overall system. The longer-term stability of the catalyst as well as its tolerance towards different sulfur traces that occur in biogas was then evaluated and analyzed.

[1] Shuai Ma, Gabriele Loreti, Ligang Wang, Andrea L. Facci, Stefano Ubertini, Changqing Dong, François Maréchal, and Jan Van herle, E3S Web of Conferences 2021 238:04002
DOI: 10.1051/e3sconf/202123804002

[2] Muhammad A. Naeem, Paula M. Abdala, Andac Armutlulu, Sung Min Kim, Alexey Fedorov, and Christoph R. Müller, ACS Catalysis 2020 10 (3), 1923-1937
DOI: 10.1021/acscatal.9b04555